Vol. 77 Tuesday, 

No. 171 September 4, 2012 

Part II 

Department of Health and Human Services 

45 CFR Part 170 

Centers for Medicare & Medicaid Services 

42 CFR Parts 412, 413, and 495 

Medicare and Medicaid Programs; Electronic Health Record Incentive 

Program—Stage 2; Health Information Technology: Standards, 

Implementation Specifications, and Certification Criteria for Electronic Health 

Record Technology, 2014 Edition; Revisions to the Permanent Certification 

Program for Health Information Technology; Final Rules 

mstockstill on DSK4VPTVN1PROD with RULES2

53968 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 412, 413, and 495 

[CMS–0044–F] 

RIN 0938–AQ84 

Medicare and Medicaid Programs; 

Electronic Health Record Incentive 

Program—Stage 2 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule specifies the 

Stage 2 criteria that eligible 

professionals (EPs), eligible hospitals, 

and critical access hospitals (CAHs) 

must meet in order to qualify for 

Medicare and/or Medicaid electronic 

health record (EHR) incentive payments. 

In addition, it specifies payment 

adjustments under Medicare for covered 

professional services and hospital 

services provided by EPs, eligible 

hospitals, and CAHs failing to 

demonstrate meaningful use of certified 

EHR technology (CEHRT) and other 

program participation requirements. 

This final rule revises certain Stage 1 

criteria, as finalized in the July 28, 2010 

final rule, as well as criteria that apply 

regardless of Stage. 

DATES: Effective dates: This final rule is 

effective on November 5, 2012, with the 

exception of the definition of 

‘‘meaningful EHR user’’ in § 495.4 and 

the provisions in § 495.6(f), § 495.6(g), 

§ 495.8, § 495.102(c), and part 495 

subpart D, which are effective 

September 4, 2012. 

Applicability dates: Sections 495.302, 

495.304, and 495.306 are applicable 

beginning payment year 2013. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Holland, (410) 786–1309, or 

Robert Anthony, (410) 786–6183, EHR 

Incentive Program issues or 

Administrative appeals process issues. 

David Koppel, (410) 786–3255, for 

Medicaid Incentive Program issues. 

Frank Szeflinski, (303) 844–7119, for 

Medicare Advantage issues. Travis 

Broome, (214) 767–4450, Medicare 

payment adjustment issues. Douglas 

Brown, (410) 786–0028, or Maria 

Michaels, (410) 786–2809 for Clinical 

quality measures issues. 

SUPPLEMENTARY INFORMATION: 

Acronyms 

ARRA American Recovery and 

Reinvestment Act of 2009 

AAC Average Allowable Cost (of CEHRT) 

ACO Accountable Care Organization 

AIU Adopt, Implement, Upgrade (CEHRT) 

CAH Critical Access Hospital 

CAHPS Consumer Assessment of 

Healthcare Providers and Systems 

CCN CMS Certification Number 

CDS Clinical Decision Support 

CEHRT Certified Electronic Health Record 

Technology 

CFR Code of Federal Regulations 

CHIP Children’s Health Insurance Program 

CHIPRA Children’s Health Insurance 

Program Reauthorization Act of 2009 

CMS Centers for Medicare & Medicaid 

Services 

CPOE Computerized Provider Order Entry 

CQM Clinical Quality Measure 

CY Calendar Year 

EHR Electronic Health Record 

EP Eligible Professional 

EPO Exclusive Provider Organization 

FACA Federal Advisory Committee Act 

FFP Federal Financial Participation 

FFY Federal Fiscal Year 

FFS Fee-For-Service 

FQHC Federally Qualified Health Center 

FTE Full-Time Equivalent 

FY Fiscal Year 

HEDIS Healthcare Effectiveness Data and 

Information Set 

HHS Department of Health and Human 

Services 

HIE Health Information Exchange 

HIT Health Information Technology 

HITPC Health Information Technology 

Policy Committee 

HIPAA Health Insurance Portability and 

Accountability Act of 1996 

HITECH Health Information Technology for 

Economic and Clinical Health Act 

HMO Health Maintenance Organization 

HOS Health Outcomes Survey 

HPSA Health Professional Shortage Area 

HRSA Health Resource and Services 

Administration 

IAPD Implementation Advance Planning 

Document 

ICR Information Collection Requirement 

IHS Indian Health Service 

IPA Independent Practice Association 

IT Information Technology 

LOINC Logical Observation Identifiers and 

Codes System 

MA Medicare Advantage 

MAC Medicare Administrative Contractor 

MAO Medicare Advantage Organization 

MCO Managed Care Organization 

MITA Medicaid Information Technology 

Architecture 

MMIS Medicaid Management Information 

Systems 

MSA Medical Savings Account 

NAAC Net Average Allowable Cost (of 

CEHRT) 

NCQA National Committee for Quality 

Assurance 

NCVHS National Committee on Vital and 

Health Statistics 

NPI National Provider Identifier 

NPRM Notice of Proposed Rulemaking 

ONC Office of the National Coordinator for 

Health Information Technology 

PAHP Prepaid Ambulatory Health Plan 

PAPD Planning Advance Planning 

Document 

PCP Primary Care Provider 

PECOS Provider Enrollment, Chain, and 

Ownership System 

PFFS Private Fee-For-Service 

PHO Physician Hospital Organization 

PHR Personal Health Record 

PHS Public Health Service 

PHSA Public Health Service Act 

PIHP Prepaid Inpatient Health Plan 

POS Place of Service 

PPO Preferred Provider Organization 

PQRS Physician Quality Reporting System 

PSO Provider Sponsored Organization 

RHC Rural Health Clinic 

RPPO Regional Preferred Provider 

Organization 

SAMHSA Substance Abuse and Mental 

Health Services Administration 

SMHP State Medicaid Health Information 

Technology Plan 

TIN Tax Identification Number 

Table of Contents 

I. Executive Summary and Overview 

A. Executive Summary 

1. Purpose of Regulatory Action 

a. Need for the Regulatory Action 

b. Legal Authority for the Regulatory 

Action 

2. Summary of Major Provisions 

a. Stage 2 Meaningful Use Objectives and 

Measures 

b. Reporting on Clinical Quality Measures 

(CQMs) 

c. Payment Adjustments and Exceptions 

d. Modifications to Medicaid EHR 

Incentive Program 

e. Stage 2 Timeline Delay 

3. Summary of Costs and Benefits 

B. Overview of the HITECH Programs 

Created by the American Recovery and 

Reinvestment Act of 2009 

II. Provisions of the Proposed Regulations 

and Analysis of and Responses to Public 

Comments 

A. Definitions Across the Medicare FFS, 

Medicare Advantage, and Medicaid 

Programs 

1. Uniform Definitions 

2. Meaningful EHR User 

3. Definition of Meaningful Use 

a. Considerations in Defining Meaningful 

Use 

b. Changes to Stage 1 Criteria for 

Meaningful Use 

c. State Flexibility for Stage 2 of 

Meaningful Use 

d. Stage 2 Criteria for Meaningful Use (Core 

Set and Menu Set) 

(1) Discussion of Whether Certain EPs, 

Eligible Hospitals or CAHs can meet all 

Stage 2 Meaningful Use Objectives Given 

Established Scopes of Practice 

(2) EPs Practicing in Multiple Practices/ 

Locations 

(3) Discussion of the Reporting 

Requirements of the Measures 

Associated with the Stage 2 Meaningful 

Use Objectives 

B. Reporting on Clinical Quality Measures 

Using Certified EHRs Technology by 

Eligible Professionals, Eligible Hospitals, 

and Critical Access Hospitals 

1. Time Periods for Reporting Clinical 

Quality Measures 

2. Certification Requirements for Clinical 

Quality Measures 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53969 

3. Criteria for Selecting Clinical Quality 

Measures 

4. Clinical Quality Measures for Eligible 

Professionals 

a. Statutory and Other Considerations 

b. Clinical Quality Measures for Eligible 

Professionals for CY 2013 

c. Clinical Quality Measures for Eligible 

Professionals Beginning With CY 2014 

5. Reporting Methods for Clinical Quality 

Measures for Eligible Professionals 

a. Reporting Methods for Medicaid EPs 

b. Reporting Methods for Medicare EPs in 

CY 2013 

c. Reporting Methods for Medicare EPs 

Beginning With CY 2014 

d. Group Reporting Option for Medicare 

and Medicaid Eligible Professionals 

Beginning With CY 2014 

6. Clinical Quality Measures for Eligible 

Hospitals and Critical Access Hospitals 

a. Statutory and Other Considerations 

b. Clinical Quality Measures for Eligible 

Hospitals and CAHs for FY 2013 

7. Reporting Methods for Eligible Hospitals 

and Critical Access Hospitals 

a. Reporting Methods in FY 2013 

b. Reporting Methods Beginning With FY 

2014 

c. Electronic Reporting of Clinical Quality 

Measures for Medicaid Eligible Hospitals 

C. Demonstration of Meaningful Use and 

Other Issues 

1. Demonstration of Meaningful Use 

a. Common Methods of Demonstration in 

Medicare and Medicaid 

b. Methods for Demonstration of the Stage 

2 Criteria of Meaningful Use 

c. Group Reporting Option of Meaningful 

Use Core and Menu Objectives and 

Associated Measures for Medicare and 

Medicaid EPs Beginning With CY 2014 

2. Data Collection for Online Posting, 

Program Coordination, and Accurate 

Payments 

3. Hospital-Based Eligible Professionals 

4. Interaction With Other Programs 

D. Medicare Fee-for-Service 

1. General Background and Statutory Basis 

2. Payment Adjustment Effective in CY 

2015 and Subsequent Years for EPs Who 

Are Not Meaningful Users of CEHRT for 

an Applicable Reporting Period 

a. Applicable Payment Adjustments in CY 

2015 and Subsequent Calendar Years for 

EPs Who Are Not Meaningful Users of 

CEHRT 

b. EHR Reporting Period for Determining 

Whether an EP Is Subject to the Payment 

Adjustment for CY 2015 and Subsequent 

Calendar Years 

c. Exception to the Application of the 

Payment Adjustment to EPs in CY 2015 

and Subsequent Calendar Years 

d. HPSA Bonus Technical Change 

e. Payment Adjustment Not Applicable to 

Hospital-Based EPs 

3. Incentive Market Basket Adjustment 

Effective in FY 2015 and Subsequent 

Years for Eligible Hospitals That Are Not 

Meaningful EHR Users for an Applicable 

Reporting Period 

a. Applicable Market Basket Adjustment 

for Eligible Hospitals Who Are Not 

Meaningful EHR Users for FY 2015 and 

Subsequent FYs 

b. EHR Reporting Period for Determining 

Whether a Hospital is Subject to the 

Market Basket Adjustment for FY 2015 

and Subsequent FYs 

c. Exception to the Application of the 

Market Adjustment to Hospitals in FY 

2015 and Subsequent FYs 

d. Application of Market Basket 

Adjustment in FY 2015 and Subsequent 

FYs to a State Operating Under a 

Payment Waiver Provided by Section 

1814(B)(3) of the Act 

4. Reduction of Reasonable Cost 

Reimbursement in FY 2015 and 

Subsequent Years for CAHs That Are Not 

Meaningful EHR Users 

a. Applicable Reduction of Reasonable Cost 

Payment Reduction in FY 2015 and 

Subsequent Years for CAHs That Are Not 

Meaningful EHR Users 

b. EHR Reporting Period for Determining 

Whether a CAH Is Subject to the 

Applicable Reduction of Reasonable Cost 

Payment in FY 2015 and Subsequent 

Years 

c. Exception to the Application of 

Reasonable Cost Payment Reductions to 

CAHs in FY 2015 and Subsequent FYs 

5. Administrative Review Process of 

Certain Electronic Health Record 

Incentive Program Determinations 

E. Medicare Advantage Organization 

Incentive Payments 

1. Definition (§ 495.200) 

2. Identification of Qualifying MA 

Organizations, MA–EPs and MAAffiliated Eligible Hospitals (§ 495.202) 

3. Incentive Payments to Qualifying MA 

Organizations for Qualifying MA EPs 

and Qualifying MA-Affiliated Eligible 

Hospitals (§ 495.204) 

a. Amount Payable to a Qualifying MA 

Organization for Its Qualifying MA EPs 

b. Increase in Incentive Payment for MA 

EPs Who Predominantly Furnish 

Services in a Geographic Health 

Professional Shortage Area (HPSA) 

4. Avoiding Duplicate Payments 

5. Payment Adjustments Effective in 2015 

and Subsequent MA Payment 

Adjustment Years (§ 495.211). 

6. Reconsideration Process for MA 

Organizations 

F. Revisions and Clarifications to the 

Medicaid EHR Incentive Program 

1. Net Average Allowable Costs 

2. Eligibility Requirements for Children’s 

Hospitals 

3. Medicaid Professionals Program 

Eligibility 

a. Calculating Patient Volume 

Requirements 

b. Practices Predominately 

4. Medicaid Hospital Incentive Payment 

Calculation 

a. Discharge Related Amount 

b. Acute Care Inpatient Bed Days and 

Discharges for the Medicaid Share and 

Discharge- Related Amount 

c. Hospitals Switching States 

5. Hospital Demonstrations of Meaningful 

Use—Auditing and Appeals 

6. State Flexibility for Stage 2 of 

Meaningful Use 

7. State Medicaid Health Information 

Technology Plan (SMHP) and 

Implementation Advance Planning 

Document (IAPD) 

a. Frequency of Health Information 

Technology (HIT) Implementation 

Advanced Planning Document (IAPD) 

Updates 

b. Requirements of States Transitioning 

From HIT Planning Advanced Planning 

Documents (P–APDs) to HIT IAPDs 

III. Waiver of Delay in Effective Date 

IV. Collection of Information Requirements 

A. ICR Regarding Demonstration of 

Meaningful Use Criteria (§ 495.6 and 

§ 495.8) 

B. ICRs Regarding Qualifying MA 

Organizations (§ 495.210) 

C. ICRs Regarding State Medicaid Agency 

and Medicaid EP and Hospital Activities 

(§ 495.332 Through § 495.344) 

V. Regulatory Impact Analysis 

A. Statement of Need 

B. Overall Impact 

C. Anticipated Effects 

1. Overall Effects 

a. Regulatory Flexibility Analysis and 

Small Entities 

(1) Number of Small Entities 

(2) Conclusion 

b. Small Rural Hospitals 

c. Unfunded Mandates Reform Act 

d. Federalism 

2. Effects on Eligible Professionals, Eligible 

Hospitals, and CAHs 

a. Background and Assumptions 

b. Industry Costs and Adoption Rates 

c. Costs of EHR Adoption for EPs 

d. Costs of EHR Adoption for Eligible 

Hospitals 

3. Medicare Incentive Program Costs 

a. Medicare Eligible Professionals (EPs) 

b. Medicare Eligible Hospitals and CAHs 

c. Critical Access Hospitals (CAHs) 

4. Medicaid Incentive Program Costs 

a. Medicaid EPs 

b. Medicaid Hospitals 

5. Benefits For All EPs and All Eligible 

Hospitals 

6. Benefits to Society 

7. General Considerations 

8. Summary 

9. Explanation of Benefits and Savings 

Calculations 

D. Accounting Statement 

E. Conclusion 

Regulations Text 

I. Executive Summary and Overview 

A. Executive Summary 

1. Purpose of Regulatory Action 

a. Rationale for the Regulatory Action 

In this final rule the Secretary of the 

Department of Health and Human 

Services (the Secretary) will specify 

Stage 2 criteria beginning in 2014 that 

eligible professionals (EPs), eligible 

hospitals, and critical access hospitals 

(CAHs) must meet in order to qualify for 

an incentive payment, as well as 

introduce changes to the program 

timeline and detail Medicare payment 

adjustments. Recommendations on 

Stage 2 criteria from the Health IT 

mstockstill on DSK4VPTVN1PROD with RULES2

53970 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

Policy Committee (HITPC), a Federal 

Advisory Committee that coordinates 

industry and provider input regarding 

the Medicare and Medicaid Electronic 

Health Record (EHR) Incentive Programs 

were substantially adopted, with 

consideration of current program data 

for the Medicare and Medicaid EHR 

Incentive Programs. Our current 

program data is derived from two 

sources. First, data elements from the 

registration and attestation process of 

those providers who have already 

registered and attested to Stage 1 of 

meaningful use. This includes 

demographic information about the 

provider, the Certified EHR Technology 

(CEHRT) used by the provider and their 

performance on the meaningful use 

objectives and measures. Second, we 

have information from thousands of 

questions providers submitted about the 

EHR Incentive Programs. These 

questions provide insights into the 

difficulties faced by providers and also 

into the areas of the EHR Incentive 

Programs that warrant additional 

clarification. 

b. Legal Authority for the Regulatory 

Action 

The American Recovery and 

Reinvestment Act of 2009 (ARRA) (Pub. 

L. 111–5) amended Titles XVIII and XIX 

of the Social Security Act (the Act) to 

authorize incentive payments to EPs, 

eligible hospitals, and CAHs, and 

Medicare Advantage (MA) organizations 

to promote the adoption and meaningful 

use of CEHRT. 

Sections 1848(o), 1853(l) and (m), 

1886(n), and 1814(l) of the Act provide 

the statutory basis for the Medicare 

incentive payments made to meaningful 

EHR users. These statutory provisions 

govern EPs, Medicare Advantage (MA) 

organizations (for certain qualifying EPs 

and hospitals that meaningfully use 

CEHRT), subsection (d) hospitals and 

critical access hospitals (CAHs) 

respectively. Sections 1848(a)(7), 1853(l) 

and (m), 1886(b)(3)(B), and 1814(l) of 

the Act also establish downward 

payment adjustments, beginning with 

calendar or fiscal year 2015, for EPs, MA 

organizations, subsection (d) hospitals 

and CAHs that are not meaningful users 

of CEHRT for certain associated 

reporting periods. 

Sections 1903(a)(3)(F) and 1903(t) of 

the Act provide the statutory basis for 

Medicaid incentive payments. (There 

are no payment adjustments under 

Medicaid). For a more detailed 

explanation of the statutory basis for the 

EHR incentive payments, see the Stage 

1 final rule (75 FR 44316 through 

44317). 

2. Summary of Major Provisions 

a. Stage 2 Meaningful Use Objectives 

and Measures 

In the Stage 1 final rule we outlined 

Stage 1 meaningful use criteria, we 

finalized a separate set of core objectives 

and menu objectives for EPs, eligible 

hospitals and CAHs. EPs and hospitals 

must meet the measure or qualify for an 

exclusion to all 15 core objectives and 

5 out of the 10 menu objectives in order 

to qualify for an EHR incentive 

payment. In this final rule, we maintain 

the same core-menu structure for the 

program for Stage 2. We are finalizing 

that EPs must meet the measure or 

qualify for an exclusion to 17 core 

objectives and 3 of 6 menu objectives. 

We are finalizing that eligible hospitals 

and CAHs must meet the measure or 

qualify for an exclusion to 16 core 

objectives and 3 of 6 menu objectives. 

Nearly all of the Stage 1 core and menu 

objectives are retained for Stage 2. The 

‘‘exchange of key clinical information’’ 

core objective from Stage 1 was reevaluated in favor of a more robust 

‘‘transitions of care’’ core objective in 

Stage 2, and the ‘‘Provide patients with 

an electronic copy of their health 

information’’ objective was removed 

because it was replaced by a ‘‘view 

online, download, and transmit’’ core 

objective. There are also multiple Stage 

1 objectives that were combined into 

more unified Stage 2 objectives, with a 

subsequent rise in the measure 

threshold that providers must achieve 

for each objective that has been retained 

from Stage 1. 

b. Reporting on Clinical Quality 

Measures (CQMs) 

EPs, eligible hospitals, and CAHs are 

required to report on specified clinical 

quality measures in order to qualify for 

incentive payments under the Medicare 

and Medicaid EHR Incentive Programs. 

This final rule outlines a process by 

which EPs, eligible hospitals, and CAHs 

will submit CQM data electronically, 

reducing the associated burden of 

reporting on quality measures for 

providers. EPs will submit 9 CQMs from 

at least 3 of the National Quality 

Strategy domains out of a potential list 

of 64 CQMs across 6 domains. We are 

recommending a core set of 9 CQMs 

focusing on adult populations with a 

particular focus on controlling blood 

pressure. We are also recommending a 

core set of 9 CQMs for pediatric 

populations. EPs should report on these 

recommended CQMs if they are 

representative of their clinical practice 

and patient population. Eligible 

hospitals and CAHs will submit 16 

CQMs from at least 3 of the National 

Quality Strategy domains out of a 

potential list of 29 CQMs across 6 

domains. For the Medicare EHR 

Incentive Program, EPs, eligible 

hospitals, and CAHs in their first year 

of demonstrating meaningful use must 

submit their CQM data via attestation, 

and those beyond their first year must 

submit their CQM data electronically 

via a CMS-designated transmission 

method. For EPs, this includes an 

aggregate electronic submission or a 

patient-level electronic submission 

through the method specified by the 

Physician Quality Reporting System 

(PQRS) that would provide one 

submission for credit in both the PQRS 

and Medicare EHR Incentive Program. 

For eligible hospitals and CAHs, this 

includes an aggregate electronic 

submission or a patient-level data 

submission through the method similar 

to the Medicare EHR Incentive Program 

Electronic Reporting Pilot, which is 

proposed for extension in the CY 2013 

Hospital Outpatient Prospective 

Payment System (OPPS) proposed rule 

(July 30, 2012, 77 FR 45188). For 

electronic submissions, patient-level 

data must be submitted using the 

Quality Reporting Data Architecture 

(QRDA) Category I format, and 

aggregate-level data must be submitted 

using the QRDA Category III format. 

c. Payment Adjustments and Exceptions 

Medicare payment adjustments are 

required by statute to take effect in 

2015. We are finalizing a process by 

which payment adjustments will be 

determined by a prior reporting period. 

Therefore, we specify that EPs and 

eligible hospitals that are meaningful 

EHR users in 2013 will avoid payment 

adjustment in 2015. Also, if such 

providers first meet meaningful use in 

2014, they will avoid the 2015 payment 

adjustment, if they are able to 

demonstrate meaningful use at least 3 

months prior to the end of the calendar 

(for EPs) or fiscal year (for eligible 

hospitals) and meet the registration and 

attestation requirement by July 1, 2014 

(for eligible hospitals) or October 1, 

2014 (for EPs). 

We also are finalizing exceptions to 

these payment adjustments. This final 

rule outlines four categories of 

exceptions based on (1) the lack of 

availability of internet access or barriers 

to obtaining IT infrastructure; (2) a timelimited exception for newly practicing 

EPs or new hospitals that will not 

otherwise be able to avoid payment 

adjustments; (3) unforeseen 

circumstances such as natural disasters 

that will be handled on a case-by-case 

basis; and (4) (EP only) exceptions due 

to a combination of clinical features 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53971 

limiting a provider’s interaction with 

patients or, if the EP practices at 

multiple locations, lack of control over 

the availability of CEHRT at practice 

locations constituting 50 percent or 

more of their encounters. 

d. Modifications to Medicaid EHR 

Incentive Program 

We are expanding the definition of 

what constitutes a Medicaid patient 

encounter, which is a required 

eligibility threshold for the Medicaid 

EHR Incentive Programs. We include 

encounters for individuals enrolled in a 

Medicaid program, including Title XXIfunded Medicaid expansion encounters 

(but not separate Children’s Health 

Insurance Programs (CHIPs)). We also 

specify flexibility in the lookback period 

for patient volume to be over the 12 

months preceding attestation, not tied to 

the prior calendar year. 

We are also making eligible 

approximately 12 additional children’s 

hospitals that have not been able to 

participate to date, despite meeting all 

other eligibility criteria, because they do 

not have a CMS Certification Number 

since they do not bill Medicare. 

These changes would take effect 

beginning with payment year 2013. 

e. Stage 2 Timeline Delay 

Lastly, we are finalizing a delay in the 

implementation of the onset of Stage 2 

criteria. In the Stage 1 final rule, we 

established that any provider who first 

attested to Stage 1 criteria in 2011 

would begin using Stage 2 criteria in 

2013. This final rule delays the onset of 

those Stage 2 criteria until 2014, which 

we believe provides the needed time for 

vendors to develop CEHRT. We are also 

introducing a special 3-month EHR 

reporting period, rather than a full year 

of reporting, for providers attesting to 

either Stage 1 or Stage 2 in 2014 in order 

to allow time for providers to 

implement newly certified CEHRT. In 

future years, providers who are not in 

their initial year of demonstrating 

meaningful use must meet criteria for 

12-month reporting periods. The 3- 

month reporting period allows 

providers flexibility in their first year of 

meeting Stage 2 without warranting any 

delay for Stage 3. This policy is 

consistent with CMS’s commitment to 

ensure that Stage 3 occurs on schedule 

(implemented by 2016). 

3. Summary of Costs and Benefits 

This final rule is anticipated to have 

an annual effect on the economy of $100 

million or more, making it an 

economically significant rule under the 

Executive Order and a major rule under 

the Congressional Review Act. 

Accordingly, we have prepared a 

Regulatory Impact Analysis that to the 

best of our ability presents the costs and 

benefits of the final rule. The total 

Federal cost of the Medicare and 

Medicaid EHR Incentive Programs 

between 2014 and 2019 is estimated to 

be $15.4 billion (these estimates include 

net payment adjustments for Medicare 

providers who do not achieve 

meaningful use in 2015 and subsequent 

years in the amount of $2.1 billion). In 

this final rule we have not quantified 

the overall benefits to the industry, nor 

to EPs, eligible hospitals, or CAHs 

participating in the Medicare and 

Medicaid EHR Incentive Programs. 

Information on the costs and benefits of 

adopting systems specifically meeting 

the requirements for the EHR Incentive 

Programs has not yet been collected and 

information on costs and benefits 

overall is limited. Nonetheless, we 

believe there are substantial benefits 

that can be obtained by eligible 

hospitals and EPs, including reductions 

in medical recordkeeping costs, 

reductions in repeat tests, decreases in 

length of stay, increased patient safety, 

and reduced medical errors. There is 

evidence to support the cost-saving 

benefits anticipated from wider 

adoption of EHRs. 

TABLE 1—ESTIMATED EHR INCENTIVE PAYMENTS AND BENEFITS IMPACTS ON THE MEDICARE AND MEDICAID PROGRAMS

OF THE HITECH EHR INCENTIVE PROGRAM. (FISCAL YEAR)—(IN BILLIONS) 

Fiscal year 

Medicare eligible Medicaid eligible 

Total 

Hospitals Professionals Hospitals Professionals 

2014 ......................................................................... $2.1 $1.9 $0.6 $0.5 $5.10 

2015 ......................................................................... 1.8 1.9 0.4 0.8 4.90 

2016 ......................................................................... 1.2 0.6 0.5 0.8 3.10 

2017 ......................................................................... 0.2 0.1 0.5 0.7 1.50 

2018 ......................................................................... ¥0.1 ¥0.2 0.1 0.7 0.50 

2019 ......................................................................... 0.0 ¥0.2 0.0 0.5 0.30 

B. Overview of the HITECH Programs 

Created by the American Recovery and 

Reinvestment Act of 2009 

The American Recovery and 

Reinvestment Act of 2009 (ARRA) (Pub. 

L. 111–5) amended Titles XVIII and XIX 

of the Social Security Act (the Act) to 

authorize incentive payments to EPs, 

eligible hospitals, and CAHs, and 

Medicare Advantage (MA) 

Organizations to promote the adoption 

and meaningful use of CEHRT. In the 

July 28, 2010 Federal Register (75 FR 

44313 through 44588) we published a 

final rule entitled ‘‘Medicare and 

Medicaid Programs; Electronic Health 

Record Incentive Program,’’ that 

specified the Stage 1 criteria that EPs, 

eligible hospitals, and CAHs must meet 

in order to qualify for an incentive 

payment, calculation of the incentive 

payment amounts, and other program 

participation requirements (hereinafter 

referred to as the Stage 1 final rule). (For 

a full explanation of the amendments 

made by ARRA, see the Stage 1 final 

rule (75 FR 44316).) In that final rule, 

we also detailed that the Medicare and 

Medicaid EHR Incentive Programs will 

consist of 3 different stages of 

meaningful use requirements. 

For Stage 1, CMS and the Office of the 

National Coordinator for Health 

Information Technology (ONC) worked 

closely to ensure that the definition of 

meaningful use of CEHRT and the 

standards and certification criteria for 

CEHRT were coordinated. Current ONC 

regulations may be found at 45 CFR part 

170. 

For Stage 2, CMS and ONC again 

worked together to align our regulations. 

In the March 7, 2012 Federal Register 

(77 FR 13698), we published a proposed 

rule that specified the potential Stage 2 

criteria that EPs, eligible hospitals, and 

CAHs would have to meet in order to 

qualify for Medicare and/or Medicaid 

EHR incentive payments (hereinafter 

referred to as the Stage 2 proposed rule). 

In addition, the proposed rule —(1) 

proposed payment adjustments under 

Medicare for covered professional 

services and hospital services provided 

mstockstill on DSK4VPTVN1PROD with RULES2

53972 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

by EPs, eligible hospitals, and CAHs 

failing to demonstrate meaningful use of 

CEHRT and other program participation 

requirements; and (2) proposed the 

revision of certain Stage 1 criteria, as 

well as criteria that apply regardless of 

stage. 

In the April 18, 2012 Federal Register 

(77 FR 23193), we published a 

document that corrected typographical 

and technical errors in the March 7, 

2012 Stage 2 proposed rule. 

Simultaneously in the March 7, 2012 

Federal Register (77 FR 13832), ONC 

published its notice of proposed 

rulemaking titled Health Information 

Technology: Standards, Implementation 

Specifications, and Certification Criteria 

for Electronic Health Record 

Technology, 2014 Edition; Revisions to 

the Permanent Certification Program for 

Health Information Technology. The 

notice of proposed rulemaking proposed 

revisions to the initial set of standards, 

implementation specifications, and 

certification criteria in ONC’s July 28, 

2010 final rule as well as the adoption 

of new standards, implementation 

specifications, and certification criteria. 

We urge those interested in this final 

rule to also review the ONC final rule 

on standards and implementation 

specifications for CEHRT. Readers may 

also visit http://www.cms.hhs.gov/ 

EHRincentiveprograms and http:// 

healthit.hhs.gov for more information 

on the efforts at the Department of 

Health and Human Services (HHS) to 

advance HIT initiatives. 

II. Provisions of the Proposed 

Regulations and Analysis of and 

Responses to Public Comments 

We received approximately 6,100 

items of timely correspondence in 

response to our Stage 2 proposed rule 

published in the March 7, 2012 Federal 

Register. We received some comments 

that were outside the scope of the 

proposed rule and therefore are not 

addressed in this final rule. Summaries 

of the timely public comments that are 

within the scope of the Stage 2 proposed 

rule and our responses to those 

comments are set forth in the various 

sections of this final rule under the 

appropriate headings. We have 

generally organized those sections by 

stating our proposals, summarizing and 

responding to the timely public 

comments received, and describing our 

final policy. 

A. Definitions Across the Medicare FFS, 

Medicare Advantage, and Medicaid 

Programs 

1. Uniform Definitions 

As discussed in the proposed rule, in 

the Stage 1 final rule, we finalized many 

uniform definitions for the Medicare 

FFS, Medicare Advantage (MA), and 

Medicaid EHR incentive programs. 

These definitions are set forth in part 

495 subpart A of the regulations, and we 

proposed to maintain most of these 

definitions, including, for example, 

‘‘Certified EHR Technology (CEHRT),’’ 

‘‘Qualified EHR,’’ ‘‘Payment Year,’’ and 

‘‘First, Second, Third, Fourth, Fifth, and 

Sixth Payment Year.’’ We noted in the 

Stage 2 proposed rule that our 

definitions of ‘‘CEHRT’’ and ‘‘Qualified 

EHR’’ incorporate the definitions 

adopted by ONC, and to the extent that 

ONC’s definitions are revised, our 

definitions would also incorporate those 

changes. For these definitions, we refer 

readers to ONC’s standards and 

certification criteria final rule that is 

published elsewhere in this issue of the 

Federal Register. 

We did not receive any comments on 

our proposal and will continue to use 

the existing definitions in part 495 

subpart A, except where stated 

otherwise in this final rule. 

We stated that we would revise the 

descriptions of the EHR reporting period 

to clarify that providers who are 

demonstrating meaningful use for the 

first time would have an EHR reporting 

period of 90 days regardless of payment 

year. We proposed to add definitions for 

the applicable EHR reporting period that 

would be used in determining the 

payment adjustments, as well as a 

definition of a payment adjustment year. 

A summary of the comments 

pertaining to the EHR reporting period, 

the applicable EHR reporting period for 

determining the payment adjustments, 

and the definition of a payment 

adjustment year, as well as our 

responses to those comments, can be 

found in sections II.A.3.a and II.D.2 of 

this final rule. 

2. Meaningful EHR User 

We proposed to include clinical 

quality measure reporting as part of the 

definition of ‘‘meaningful EHR user’’ 

under § 495.4 instead of as a separate 

meaningful use objective under § 495.6. 

Comment: A few commenters 

suggested that this change would create 

confusion, but the majority supported 

this change to alleviate confusion 

caused by the current situation. Many 

comments discussed the specifics of 

clinical quality measures. 

Response: We appreciate the support 

expressed for the proposal. We continue 

to believe that separating clinical 

quality measures from the meaningful 

use objectives and measures in § 495.6 

will reduce confusion and finalize the 

change as proposed. We address 

comments on the specifics of clinical 

quality measures in section II.B of this 

final rule. While clinical quality 

measure reporting will no longer be 

listed as a separate objective and 

measure in § 495.6, as it is now 

incorporated in the definition of 

meaningful EHR user in § 495.4, it 

remains a condition for demonstrating 

meaningful use. 

We proposed to revise the third 

paragraph of the definition of 

meaningful EHR user at § 495.4 to refer 

specifically to the payment adjustments 

and read as follows: ‘‘(3) To be 

considered a meaningful EHR user, at 

least 50 percent of an EP’s patient 

encounters during an EHR reporting 

period for a payment year (or during an 

applicable EHR reporting period for a 

payment adjustment year) must occur at 

a practice/location or practices/ 

locations equipped with CEHRT.’’ We 

did not receive any comments on this 

revision and we are finalizing it as 

proposed. 

3. Definition of Meaningful Use 

a. Considerations in Defining 

Meaningful Use 

In sections 1848(o)(2)(A) and 

1886(n)(3)(A) of the Act, the Congress 

identified the broad goal of expanding 

the use of EHRs through the concept of 

meaningful use. Section 1903(t)(6)(C) of 

the Act also requires that Medicaid 

providers adopt, implement, upgrade or 

meaningfully use CEHRT if they are to 

receive incentives under Title XIX. 

CEHRT used in a meaningful way is one 

piece of the broader HIT infrastructure 

needed to reform the health care system 

and improve health care quality, 

efficiency, and patient safety. This 

vision of reforming the health care 

system and improving health care 

quality, efficiency, and patient safety 

should inform the definition of 

meaningful use. 

As we explained in our Stage 1 

meaningful use rule and again in our 

Stage 2 proposed rule, we seek to 

balance the sometimes competing 

considerations of health system 

advancement (for example, improving 

health care quality, encouraging 

widespread EHR adoption, promoting 

innovation) and minimizing burdens on 

health care providers given the short 

timeframe available under the HITECH 

Act. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53973 

Based on public and stakeholder 

input received during our Stage 1 rule, 

we laid out a phased approach to 

meaningful use. Such a phased 

approach encompasses reasonable 

criteria for meaningful use based on 

currently available technology 

capabilities and provider practice 

experience, and builds up to a more 

robust definition of meaningful use as 

technology and capabilities evolve. The 

HITECH Act acknowledges the need for 

this balance by granting the Secretary 

the discretion to require more stringent 

measures of meaningful use over time. 

Ultimately, consistent with other 

provisions of law, meaningful use of 

CEHRT should result in health care that 

is patient centered, evidence-based, 

prevention-oriented, efficient, and 

equitable. 

Under this phased approach to 

meaningful use, we update the criteria 

of meaningful use through staggered 

rulemaking. We published the Stage 1 

final rule (75 FR 44314) on July 28, 

2010, and this rule finalizes the criteria 

and other requirements for Stage 2. We 

currently are planning at least one 

additional update, and anticipate 

finalizing the Stage 3 criteria through 

additional rulemaking in early 2014 

with Stage 3 starting in 2016. The stages 

represent an initial graduated approach 

to arriving at the ultimate goal. 

• The Stage 1 meaningful use criteria, 

consistent with other provisions of 

Medicare and Medicaid law, focused on 

electronically capturing health 

information in a structured format; 

using that information to track key 

clinical conditions and communicating 

that information for care coordination 

purposes (whether that information is 

structured or unstructured, but in 

structured format whenever feasible); 

implementing clinical decision support 

tools to facilitate disease and 

medication management; using EHRs to 

engage patients and families and 

reporting clinical quality measures and 

public health information. Stage 1 

focused heavily on establishing the 

functionalities in CEHRT that will allow 

for continuous quality improvement and 

ease of information exchange. By having 

these functionalities in CEHRT at the 

onset of the program and requiring that 

the EP, eligible hospital or CAH become 

familiar with them through the varying 

levels of engagement required by Stage 

1, we believe we created a strong 

foundation to build on in later years. 

Though some functionalities were 

optional in Stage 1, all of the 

functionalities are considered crucial to 

maximize the value to the health care 

system provided by CEHRT. We 

encouraged all EPs, eligible hospitals 

and CAHs to be proactive in 

implementing all of the functionalities 

of Stage 1 in order to prepare for later 

stages of meaningful use, particularly 

functionalities that improve patient 

care, the efficiency of the health care 

system and public and population 

health. The specific criteria for Stage 1 

of meaningful use are discussed in the 

Stage 1 final rule, published on July 28, 

2010 (75 FR 44314 through 44588). We 

are finalizing certain changes to the 

Stage 1 criteria in section II.A.3.b. of 

this final rule. 

• Stage 2: We stated in the Stage 2 

proposed rule that our Stage 2 goals, 

consistent with other provisions of 

Medicare and Medicaid law, would 

expand upon the Stage 1 criteria with a 

focus on ensuring that the meaningful 

use of EHRs supports the aims and 

priorities of the National Quality 

Strategy. Specifically, Stage 2 

meaningful use criteria would 

encourage the use of health IT for 

continuous quality improvement at the 

point of care and the exchange of 

information in the most structured 

format possible. Our proposed Stage 2 

meaningful use requirements included 

rigorous expectations for health 

information exchange including: more 

demanding requirements for eprescribing; incorporating structured 

laboratory results; and the expectation 

that providers will electronically 

transmit patient care summaries with 

each other and with the patient to 

support transitions in care. Increasingly 

robust expectations for health 

information exchange in Stage 2 and 

Stage 3 would support the goal that 

information follows the patient. In 

addition, as we forecasted in the Stage 

1 final rule, we proposed that nearly 

every objective that was optional for 

Stage 1 would be part of the core for 

Stage 2. 

• Stage 3: We anticipate that Stage 3 

meaningful use criteria will focus on: 

promoting improvements in quality, 

safety and efficiency leading to 

improved health outcomes; focusing on 

decision support for national high 

priority conditions; patient access to 

self-management tools; access to 

comprehensive patient data through 

robust, secure, patient-centered health 

information exchange; and improving 

population health. For Stage 3, we 

currently intend to propose higher 

standards for meeting meaningful use. 

For example, we intend to propose that 

every objective in the menu set for Stage 

2 be included in Stage 3 as part of the 

core set. While the use of a menu set 

allows providers flexibility in setting 

priorities for EHR implementation and 

takes into account their unique 

circumstances, we maintain that all of 

the objectives are crucial to building a 

strong foundation for health IT and to 

meeting the objectives of the HITECH 

Act. In addition, as the capabilities of 

HIT infrastructure increase, we may 

raise the thresholds for these objectives 

in both Stage 2 and Stage 3. 

In the Stage 1 final rule (75 FR 44323), 

we published the following Table 2 with 

our expected timeline for the stages of 

meaningful use. 

TABLE 2—STAGE OF MEANINGFUL USE CRITERIA BY PAYMENT YEAR AS FINALIZED IN 2010 

First payment year 

Payment year 

2011 2012 2013 2014 2015 

2011 ........................... Stage 1 ..................... Stage 1 ..................... Stage 2 ..................... Stage 2 ..................... TBD 

2012 ........................... ................................... Stage 1 ..................... Stage 1 ..................... Stage 2 ..................... TBD 

2013 ........................... ................................... ................................... Stage 1 ..................... Stage 1 ..................... TBD 

2014 ........................... ................................... ................................... ................................... Stage 1 ..................... TBD 

We proposed changes to this timeline 

as well as its extension beyond 2014. As 

we explained in the Stage 2 proposed 

rule, under the timeline used in Table 

2, an EP, eligible hospital, or CAH that 

became a meaningful EHR user for the 

first time in 2011 would need to begin 

their EHR reporting period for Stage 2 

on January 1, 2013 (EP) or October 1, 

2012 (eligible hospital or CAH). The 

HITPC recommended we delay by 1 

year the start of Stage 2 for providers 

who became meaningful EHR users in 

2011. We stated in the proposed rule 

that Stage 2 of meaningful use would 

require changes to both technology and 

workflow that cannot reasonably be 

expected to be completed in the time 

mstockstill on DSK4VPTVN1PROD with RULES2

53974 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

between the publication of the final rule 

and the start of the EHR reporting 

periods as listed in Table 2. We noted 

the similar concerns we have heard 

from other stakeholders and agreed that, 

based on our proposed definition of 

meaningful use for Stage 2, providers 

could have difficulty implementing 

these changes in time. Therefore, we 

proposed a 1-year extension of Stage 1 

of meaningful use for providers who 

successfully demonstrated meaningful 

use for 2011. Our proposed timeline 

through 2021, which we finalize in this 

rule with a notation of the special EHR 

reporting period in 2014, is displayed in 

Table 3. We refer readers to section 

II.D.2 of this final rule for a discussion 

of the applicable EHR reporting period 

that will be used to determine whether 

providers are subject to payment 

adjustments. 

TABLE 3—STAGE OF MEANINGFUL USE CRITERIA BY FIRST PAYMENT YEAR

First payment year 

Stage of meaningful use 

2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 

2011 ................................................. 1 1 1 *2 2 3 3 TBD TBD TBD TBD 

2012 ................................................. ............ 1 1 *2 2 3 3 TBD TBD TBD TBD 

2013 ................................................. ............ ............ 1 *1 2 2 3 3 TBD TBD TBD 

2014 ................................................. ............ ............ ............ *1 1 2 2 3 3 TBD TBD 

2015 ................................................. ............ ............ ............ ............ 1 1 2 2 3 3 TBD 

2016 ................................................. ............ ............ ............ ............ ............ 1 1 2 2 3 3 

2017 ................................................. ............ ............ ............ ............ ............ ............ 1 1 2 2 3 

*3-month quarter EHR reporting period for Medicare and continuous 90-day EHR reporting period (or 3 months at state option) for Medicaid 

EPs. All providers in their first year in 2014 use any continuous 90-day EHR reporting period. 

We explained in the proposed rule 

that the Medicare EHR incentive 

program and the Medicaid EHR 

incentive program have different rules 

regarding the number of payment years 

available, the last year for which 

incentives may be received, and the last 

payment year for initiating the program. 

The last year for which an EP and an 

eligible hospital or CAH can begin 

receiving Medicare incentive payments 

is 2014 and 2015 respectively. These 

providers would begin in Stage 1 of 

meaningful use. Medicaid EPs and 

eligible hospitals can receive a Medicaid 

EHR incentive payment for ‘‘adopting, 

implementing, and upgrading’’ (AIU) to 

CEHRT for their first payment year, 

which is not reflected in Table 3. For 

example, a Medicaid EP who earns an 

incentive payment for AIU in 2013 

would have to meet Stage 1 of 

meaningful use in his or her next 2 

payment years (2014 and 2015). The 

applicable payment years and the 

incentive payments available for each 

program are discussed in the Stage 1 

final rule. 

If we anticipate future criteria beyond 

Stage 3 of meaningful use, we expect to 

update Table 3 in the rulemaking for 

Stage 3, which remains on schedule for 

implementation in 2016. 

Comment: We received numerous 

comments, which represented a 

significant majority of all comments 

received, on the timing of the stages of 

meaningful use. Commenters asserted 

that the timeline is too aggressive and 

will result in many providers being 

unable to meet Stage 2 of meaningful 

use, particularly those who first attested 

in 2011 and 2012. The most common 

justification for this claim was the lack 

of sufficient time between the 

publication of this final rule and the 

time when a provider who first attested 

to meaningful use in 2011 or 2012 

would have to begin Stage 2 of 

meaningful use. Some commenters 

suggested that the time was insufficient 

regardless of resource constraints, while 

others suggested that currently vendors 

of CEHRT lack the necessary capacity to 

make the necessary upgrades to their 

CEHRT products and implement them 

for their customers in time. Commenters 

also pointed to competing priorities and 

demands on provider time and 

resources, such as the transition to ICD– 

10, the various programs and policies 

under the Affordable Care Act and other 

priorities that diminish the time and 

resources that can be devoted to 

reaching Stage 2 of meaningful use. 

Commenters offered several suggestions 

on how to increase the time available 

between publication of this final rule 

and the EHR reporting periods in 2014. 

The suggestions included using a 

shorter than full year EHR reporting 

period in 2014, delaying the start of 

Stage 2 until 2015 and using a shorter 

than full year EHR reporting period in 

2015, and delaying the start of Stage 2 

until 2015 with a full year EHR 

reporting period. Several commenters 

suggested a minimum of 18 months is 

needed, while others suggested longer 

periods. 

Response: While our proposal would 

provide more than a year between the 

publication of this final rule and the 

first day any provider would start their 

EHR reporting period in 2014 for any 

stage of meaningful use, we agree that 

additional time to demonstrate 

meaningful use in 2014 would be 

helpful to providers, many of whom 

will need to upgrade to new technology 

as well as ensure they are able to meet 

all of the objectives and measures for 

Stage 2. In considering what would be 

an appropriate length of time between 

publication of this final rule and the 

start of the EHR reporting periods for 

providers in 2014 for either Stage 2 or 

Stage 1, we weighed two primary factors 

against the comments calling for a 

delay. The first is that by delaying Stage 

2 until 2015, the movement towards 

improved outcomes that is the main 

goal of meaningful use would be put off 

by a full year. This full-year delay 

would have a ripple effect through the 

timeline of the stages as providers move 

along their own timelines across the 

stages of meaningful use. For this 

reason, we will not delay Stage 2 until 

2015, but instead we are using a 3- 

month EHR reporting period in 2014 as 

the first year any provider would attest 

to Stage 2. The second consideration is 

the data integrity of meaningful use 

attestations and clinical quality measure 

submissions, especially as it relates to 

our efforts towards alignment with other 

programs such as PQRS, Medicare 

Shared Savings Program (SSP), and 

potentially others. The more robust data 

set provided by a full year reporting 

period offers more opportunity for 

alignment than the data set provided by 

a shorter reporting period, especially 

compared across years. By altering the 

reporting period from year to year the 

data is less comparable from year to 

year. However, we agree with 

commenters that the use of a shorter 

EHR reporting period in 2014 is 

necessary to allow sufficient time for 

vendors to upgrade their CEHRT and for 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53975 

providers to implement it. In an effort 

to preserve some data validity with 

similar Medicare quality measurement 

programs, we are finalizing 3-month 

quarter EHR reporting periods in 2014 

for certain providers that are beyond 

their first year of meaningful use, rather 

than any continuous 90-day period 

within the year as for first-time 

meaningful users. For more information 

on alignment with other programs, we 

refer readers to our discussion on 

clinical quality measures (see section 

II.B.1. of this final rule). 

While commenters generally 

suggested a shorter EHR reporting 

period for the start of Stage 2 in any year 

rather than just Stage 2 in 2014, we 

believe that most of the reasons for a 

shorter period are due to the time 

constraints for vendor certification, 

upgrades and provider implementation 

between publication of this final rule 

and the beginning of Stage 2 in 2014. 

Any provider starting Stage 2 after 2014 

will have more time and therefore most 

of the constraints are lifted. We 

acknowledge that not all constraints go 

away, but we believe that the balance is 

sufficiently shifted such that the 

concerns of data validity and program 

alignment outweigh the few remaining 

concerns with a full year EHR reporting 

period for the provider’s first year of 

Stage 2 if it is after 2014. In addition, 

since ONC’s 2014 Edition certification is 

for all EHR systems, regardless of the 

stage of meaningful use the provider 

using that system is in, there are far 

fewer implementation concerns after 

2014. For example, if a provider begins 

Stage 2 in 2015, that provider would 

have been required to use CEHRT (that 

was certified to the 2014 Edition EHR 

certification criteria) for the previous 

year (2014) for Stage 1. 

Finally, we considered that for the 

Medicaid EHR incentive program, EPs 

work exclusively with the states as they 

must choose between either the 

Medicare or Medicaid EHR incentive 

program. We do not know whether 

shifting from an EHR reporting period of 

any continuous 90 days to a 3-month 

quarter will provide any alignment 

benefits for Medicaid EPs, and it could 

introduce system complexity for 

Medicaid agencies. Therefore, we are 

maintaining flexibility for states to 

allow Medicaid EPs to select any 

continuous 90-day EHR reporting period 

during 2014 as defined by the state 

Medicaid program, or, if the state so 

chooses, any 3-month calendar quarter 

in 2014. As nearly all hospitals 

participate in both Medicare and 

Medicaid, we are using the 3-month 

quarter EHR reporting period for all 

hospitals to align both programs. 

After consideration of the public 

comments received, we are modifying 

our proposal with regard to the EHR 

reporting periods for EPs, eligible 

hospitals and CAHs that attest to 

meaningful use for 2014 for their first 

year of Stage 2 or their second year of 

Stage 1. Our final policy is as follows: 

For 2014, Medicare EPs will attest using 

an EHR reporting period of January 1, 

2014 through March 31, 2014; April 1, 

2014 through June 30, 2014; July 1, 2014 

through September 30, 2014; or October 

1, 2014 through December 31, 2014. For 

2014, Medicare and Medicaid eligible 

hospitals and CAHs will attest using an 

EHR reporting period of October 1, 2013 

through December 31, 2013; January 1, 

2014 through March 31, 2014; April 1, 

2014 through June 30, 2014; or July 1, 

2014 through September 30, 2014. 

Medicaid EPs will attest using an EHR 

reporting period of any continuous 90- 

day period between January 1, 2014 and 

December 1, 2014 as defined by the state 

Medicaid program, or, if the state so 

chooses, any 3-month calendar quarter 

in 2014. 

b. Changes to Stage 1 Criteria for 

Meaningful Use 

We proposed the following changes to 

the objectives and associated measures 

for Stage 1: 

• Computerized Provider Order Entry 

(CPOE)—In 2013 (CY for EPs, FY for 

eligible hospitals/CAHs), we proposed 

that providers in Stage 1 could use the 

alternative denominator of the number 

of medication orders created by the EP 

or in the eligible hospital’s or CAH’s 

inpatient or emergency department 

(POS 21 or 23) during the EHR reporting 

period (for further explanation of this 

alternative denominator, see the 

discussion of the CPOE objective in the 

Stage 2 criteria section at II.A.3.d. of this 

final rule). 

A provider seeking to meet Stage 1 in 

2013 can use either the denominator 

defined in the Stage 1 final rule or the 

alternative denominator to calculate the 

percentage for the CPOE measure. We 

also proposed to require the alternative 

denominator for Stage 1 beginning in 

2014. 

Comment: Commenters both 

supported and opposed the new 

denominator for CPOE. Those 

supporting the proposed denominator 

did so for its simplicity and greater 

accuracy for measuring actual CPOE 

usage. Those opposing the proposed 

denominator did so either because they 

were concerned with the burden 

associated with counting paper or other 

orders that are never entered into the 

EHR or because of the potential higher 

performance required by the proposed 

denominator. 

Response: We proposed the 

alternative denominator to alleviate the 

burden associated with measurement, 

not to create a higher performance 

threshold. As we stated in the proposed 

rule, feedback from many providers 

indicated that the alternative 

denominator was more easily 

measurable. In response to concerns 

from commenters, we are finalizing the 

alternative denominator for this 

measure and specify that providers at 

any year in Stage 1 may elect to use 

either the denominator defined in the 

Stage 1 final rule or the alternative 

denominator to calculate the percentage 

for the CPOE measure. In response to 

comments, we are not requiring that the 

alternative denominator be used 

beginning in 2014, which will give 

providers who may find it difficult to 

measure the flexibility to continue to 

use the denominator defined in the 

Stage 1 final rule. 

• Vital Signs—For the objective of 

record and chart changes in vital signs, 

the proposed Stage 2 measure would 

allow an EP to split the exclusion and 

exclude blood pressure only or height/ 

weight only (for more detail, see the 

discussion of this objective in the Stage 

2 criteria section at II.A.3.d. of the final 

rule). We proposed an identical change 

to the Stage 1 exclusion as well, starting 

in CY 2013. We also proposed changing 

the age limitations on vital signs for 

Stage 2 (for more detail, see the 

discussion of this objective in the Stage 

2 criteria section). We proposed an 

identical change to the age limitations 

on vital signs for Stage 1, starting in 

2013 (CY for EPs, FY for eligible 

hospitals/CAHs). These changes to the 

exclusion and age limitations were 

proposed as an alternative in 2013 to the 

current Stage 1 requirements but 

required for Stage 1 beginning in 2014. 

Comment: While some commenters 

suggested that these changes would be 

confusing, most commenters supported 

the changes and indicated that they 

would provide added flexibility for 

providers who seek to incorporate the 

recording of this data into their clinical 

workflow. These commenters also noted 

that the age change reflects best clinical 

practices. Some commenters suggested 

removing BMI and growth charts from 

the measure since there are no best 

practices on BMI for patients under 3 

years of age and since providers who 

would not record height and weight 

would not be able to provide BMI or 

growth charts. 

Response: We appreciate the support 

for these changes and finalize them as 

proposed. We also note that BMI and 

mstockstill on DSK4VPTVN1PROD with RULES2

53976 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

growth charts are not required to meet 

this measure but are instead a capability 

provided by CEHRT. Providers who 

claim the exclusion for height and 

weight will not have data for CEHRT to 

create either BMI or growth charts and 

this will not affect their ability to meet 

the measure of this objective. 

Comment: Some commenters 

requested clarification on whether 

providers who provide ancillary 

services and do not normally record any 

of these elements as part of their regular 

scope of practice can claim the 

exclusion. 

Response: If a provider believes that 

height and weight and/or blood pressure 

are relevant to their scope of practice, 

they must record those data elements 

and cannot qualify for the exclusion. We 

believe that most providers who provide 

ancillary services can meet the measure 

of this objective by obtaining this 

information from a referring provider 

and recording the necessary data in 

their CEHRT. 

Comment: Some providers asked for 

clarification on whether providers who 

only occasionally record height and 

weight and/or blood pressure are still 

permitted to claim the exclusions for 

this measure. 

Response: We recognize that there are 

situations in which certain providers 

may only record height and weight and/ 

or blood pressure for a very limited 

number of patients (for example, highrisk surgical patients or patients on 

certain types of medication) but do not 

normally regard these data as relevant to 

their scope of practice. When a provider 

does not believe that height and weight 

and/or blood pressure are typically 

relevant to their scope of practice but 

still records these vital signs only in 

exceptional circumstances, the provider 

is permitted to claim the exclusions for 

this measure. 

After consideration of the public 

comments received, we are finalizing 

the changes to vital signs as proposed. 

We are making technical corrections to 

the regulation text at § 495.6(d)(8) and 

§ 495.6(f)(7) to clarify these are 

alternatives in 2013 and required 

beginning in 2014. 

• Exchange Key Clinical 

Information—As noted in the proposed 

rule, the objective of ‘‘capability to 

exchange key clinical information’’ has 

been surprisingly difficult for providers 

to understand, which has made the 

objective difficult for most providers to 

achieve. We solicited comment on 

several options for this objective that we 

believed would reduce or eliminate the 

burden associated with this objective or 

increase the value of the objective. The 

first option we considered was removal 

of this objective. The second option was 

to require that the test be successful. 

The third option was to eliminate the 

objective, but require that providers 

select either the Stage 1 medication 

reconciliation objective or the Stage 1 

summary of care at transitions of care 

and referrals objective from the menu 

set. The fourth option was to move from 

a test to one case of actual electronic 

transmission of a summary of care 

document for a real patient either to 

another provider of care at a transition 

or referral or to a patient authorized 

entity. We proposed the first option to 

remove this objective and measure from 

the Stage 1 core set beginning in 2013 

(CY for EPs, FY for eligible hospitals/ 

CAHs), but we also stated we would 

evaluate all four options in light of the 

public comments we received. 

Comment: While we received 

feedback and support from commenters 

on all of the proposed options, the 

majority of commenters supported the 

elimination of this objective for Stage 1. 

Some commenters instead supported a 

more exact definition of data exchange 

for this measure, and other commenters 

supported additional elements or 

additional requirements for exchange to 

be included as part of the measure. 

Other proposals included implementing 

a system that would allow case-by-case 

reporting of data exchange that would 

allow CMS to measure successes and 

failures by provider, vendor, and other 

elements. 

Response: We appreciate the many 

suggestions from commenters on 

clarifying data exchange and/or adding 

requirements to the measure. We also 

appreciate the suggestion of a case-bycase reporting system for data exchange. 

However, we are concerned that all of 

these options would not alleviate but 

actually increase the burden of this 

measure for providers by requiring them 

to document and submit substantially 

greater information than is currently 

required by attestation. While such a 

burden may be justified, we do not 

believe it is in this case because the 

Stage 2 requirements for actual 

electronic exchange of summary of care 

records create sufficient incentive to 

begin testing in Stage 1 without there 

being an explicit meaningful use 

requirement to do so. Because of these 

concerns and in reaction to the opinion 

of most commenters, we are finalizing 

the removal of this objective and 

measure for Stage 1 beginning in 2013. 

Although some commenters suggested 

removing this objective earlier, we do 

not believe the timing of publication of 

this final rule would allow us to 

implement such a change and allow 

consistent reporting for all providers in 

2012. Therefore, this objective and 

measure will be removed from the Stage 

1 criteria beginning in 2013 (CY for EPs, 

FY for eligible hospitals and CAHs). 

• View Online, Download, and 

Transmit—We proposed for Stage 2 a 

new method for making patient 

information available electronically, 

which would enable patients to view 

online, download, and transmit their 

health information and hospital 

admission information. We discuss in 

the Stage 2 criteria section at II.A.3.d the 

‘‘view online, download, and transmit’’ 

objectives for EPs and hospitals. We 

noted in the proposed rule that starting 

in 2014, CEHRT would no longer be 

certified to the Stage 1 EP and hospital 

core objectives of providing patients 

with electronic copies of their health 

information (§ 495.6(d)(12) and (f)(11)) 

or the Stage 1 hospital core objective of 

providing patients with electronic 

copies of their discharge instructions 

upon request (§ 495.6(f)(12)), nor would 

it support the Stage 1 EP menu objective 

of providing patients with timely 

electronic access to their health 

information (§ 495.6(e)(5)). Therefore 

starting in 2014, for Stage 1, we 

proposed to replace these objectives 

with the new ‘‘view online, download 

and transmit’’ objectives. 

Comment: There were a number of 

commenters who asked for clarifications 

regarding the requirements of these 

objectives. Other commenters raised 

concerns regarding the implementation 

of these objectives in both Stage 1 and 

Stage 2. 

Response: We discuss the 

clarifications and concerns raised by 

commenters in our Stage 2 criteria at 

II.A.3.d regarding these objectives. 

Please refer to those discussions for 

additional information. 

Comment: Some commenters 

supported this change while other 

commenters disagreed with it. Those 

who disagreed with the proposed 

change indicated that providers would 

not be ready to implement online access 

to health information in Stage 1, and 

that it was unlikely that providers could 

convince more than 50 percent of 

patients to sign up for online access 

within the Stage 1 reporting period. 

These commenters suggested 

eliminating all of the Stage 1 objectives 

for providing electronic copies of health 

information or discharge summaries and 

not replacing these objectives with the 

‘‘view, download, and transmit’’ 

objectives. 

Response: We disagree that the Stage 

1 objectives for providing patients with 

electronic copies of their health 

information and discharge instructions 

should be eliminated without replacing 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53977 

these objectives with the ‘‘view online, 

download, and transmit’’ objectives. We 

believe patient access to their health 

information is an important aspect of 

patient care and engagement, and we 

further believe that the capabilities of 

CEHRT in 2014 and beyond will enable 

providers to make this information 

available online in a way that does not 

impose a significant burden on 

providers. 

We note that only the first measure of 

the ‘‘view online, download, and 

transmit’’ objectives would be required 

for Stage 1. This means that providers 

would only have to make information 

available online to view online, 

download, and transmit for more than 

50 percent of all unique patients during 

the EHR reporting period in order to 

meet the measure. We further clarify 

that providers are only required to make 

this information available online to 

view online, download, and transmit 

and that patients who do not access the 

information or would not affect whether 

or not the provider is able to meet the 

measure. For Stage 1, providers are not 

required to meet the second measure of 

more than 5 percent of patients view 

online, download, or transmit to a third 

party their health or hospital admission 

information. Providers are only required 

to meet the second measure of the 

objectives in Stage 2. However, the 

exclusions for these objectives are 

available for providers in Stage 1. 

Therefore, we are finalizing our 

proposal to replace the existing Stage 1 

EP and hospital objectives listed above 

with the ‘‘view online, download, and 

transmit’’ objectives beginning in 2014 

for Stage 1. We are making a technical 

correction to the regulations text to 

clarify that the existing Stage 1 objective 

at § 495.6(f)(11) is being replaced. We 

clarify in Table 4 the four existing Stage 

1 objectives that are being replaced. We 

are also making a technical correction to 

the regulation text to remove the 

existing exclusion for the objective at 

§ 495.6(f)(12)(iii) beginning in 2014 

because the objective that this exclusion 

applies to is being replaced. 

• Removing CQM Reporting from 

Stage 1 Objectives—We proposed a 

revised definition of a meaningful EHR 

user at § 495.4 which would incorporate 

the requirement to submit clinical 

quality measures, as discussed in 

section II.A.2 of this final rule. We also 

proposed to remove the objective to 

submit clinical quality measures from 

§ 495.6 beginning in 2013 for Stage 1 to 

conform with this change in the 

definition of a meaningful EHR user. 

Comment: While some commenters 

indicated that this change would be 

confusing, most commenters supported 

this change. 

Response: We appreciate the support 

of commenters and believe that 

removing the objective will actually 

alleviate confusion. Therefore, as 

discussed earlier in II.A.2. of this final 

rule, we are finalizing as proposed, the 

revised definition of a meaningful EHR 

user at § 495.4 to include clinical 

quality measure submission, as well as 

the removal of this objective from 

§ 495.6 beginning in 2013. 

• Public Health Objectives—For the 

Stage 1 public health objectives, 

beginning in 2013, we proposed to add 

‘‘except where prohibited’’ to the 

regulation text in order to encourage all 

EPs, eligible hospitals, and CAHs to 

submit electronic immunization data, 

even when not required by state/local 

law. Therefore, if they are authorized to 

submit the data, they should do so even 

if it is not required by either law or 

practice. There are a few instances 

where some EPs, eligible hospitals, and 

CAHs are prohibited from submitting to 

a state/local immunization registry. For 

example, in sovereign tribal areas that 

do not permit transmission to an 

immunization registry or when the 

immunization registry only accepts data 

from certain age groups (for example, 

adults). 

Comment: Some commenters 

supported this change while others 

disagreed with it. A number of 

commenters interpreted the proposed 

addition of language as a change to 

either the measure of the objectives or 

the exclusions that are currently in 

place. 

Response: As noted in the proposed 

rule, the addition of this language was 

intended to ensure that providers who 

are not required by law or practice to 

submit data would do so and to make 

it clear that EPs, eligible hospitals, and 

CAHs that are prohibited from 

submitting data would not be required 

to submit such data. Immunizations was 

used as a descriptive example in the 

proposed rule, but this change applies 

to all Stage 1 public health objectives. 

The exclusions provided for these 

objectives in Stage 1 are not affected by 

the addition of this language and remain 

in place for all providers. Therefore, we 

are finalizing the addition of this 

language as proposed. 

• Menu Set Exclusions Policy—We 

proposed to change the policy on menu 

set exclusions for Stage 1 beginning in 

2014. Please see section II.A.3.d. of this 

final rule for a discussion of the 

proposal and our final policy. 

• Electronic Prescribing 

Comment: We received comments 

pointing out that we proposed a new 

exclusion for electronic prescribing 

objective for Stage 2 regarding the 

availability of pharmacies that can 

accept electronic prescriptions. These 

commenters noted that if this exclusion 

was not also made available for Stage 1 

then it would create a strange scenario 

where an EP might have to 

electronically prescribe during their 2 

years of Stage 1 and then meet an 

exclusion in Stage 2. 

Response: We agree that it makes no 

sense to apply this exclusion to eprescribing in Stage 2, but not in Stage 

1. We consider it an oversight of our 

proposed rule that we did not include 

that exclusion in our proposed changes 

to the Stage 1 criteria. We are finalizing 

an exclusion for the e-prescribing 

objective in Stage 2 for any EP who does 

not have a pharmacy within their 

organization and there are no 

pharmacies that accept electronic 

prescriptions within 10 miles of the EP’s 

practice location at the start of his/her 

EHR reporting period. We are also 

finalizing the addition of this exclusion 

to Stage 1 starting in CY 2013. 

TABLE 4—STAGE 1 CHANGES

Stage 1 objective Final changes Effective year 

(CY/FY) 

Use CPOE for medication orders 

directly entered by any licensed 

healthcare professional who can 

enter orders into the medical 

record per state, local and professional guidelines.

Change: Addition of an alternative measure More than 30 percent of 

medication orders created by the EP or authorized providers of the 

eligible hospital’s or CAH’s inpatient or emergency department 

(POS 21 or 23) during the EHR reporting period are recorded 

using CPOE.

2013 - Onward (Optional). 

mstockstill on DSK4VPTVN1PROD with RULES2

53978 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 4—STAGE 1 CHANGES—Continued 

Stage 1 objective Final changes Effective year 

(CY/FY) 

Generate and transmit permissible 

prescriptions electronically (eRx).

Change: Addition of an additional exclusion Any EP who: does not 

have a pharmacy within their organization and there are no pharmacies that accept electronic prescriptions within 10 miles of the 

EP’s practice location at the start of his/her EHR reporting period.

2013—Onward (Required). 

Record and chart changes in vital 

signs.

Change: Addition of alternative age limitations More than 50 percent 

of all unique patients seen by the EP or admitted to the eligible 

hospital’s or CAH’s inpatient or emergency department (POS 21 or 

23) during the EHR reporting period have blood pressure (for patients age 3 and over only) and height and weight (for all ages) recorded as structured data.

2013 Only (Optional). 

Record and chart changes in vital 

signs.

Change: Addition of alternative exclusions ........................................... 2013 Only (Optional). 

Any EP who 

(1) Sees no patients 3 years or older is excluded from recording 

blood pressure; 

(2) Believes that all three vital signs of height, weight, and blood 

pressure have no relevance to their scope of practice is excluded from recording them; 

(3) Believes that height and weight are relevant to their scope of 

practice, but blood pressure is not, is excluded from recording 

blood pressure; or 

(4) Believes that blood pressure is relevant to their scope of 

practice, but height and weight are not, is excluded from recording height and weight. 

Record and chart changes in vital 

signs.

Change: Age limitations on height, weight and blood pressure ........... 2014—Onward (Required). 

More than 50 percent of all unique patients seen by the EP or admitted to the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) during the EHR reporting period have 

blood pressure (for patients age 3 and over only) and height and 

weight (for all ages) recorded as structured data. 

Record and chart changes in vital 

signs.

Change: Changing the age and splitting the EP exclusion .................. 2014—Onward (Required). 

Any EP who 

(1) Sees no patients 3 years or older is excluded from recording 

blood pressure; 

(2) Believes that all three vital signs of height, weight, and blood 

pressure have no relevance to their scope of practice is excluded from recording them; 

(3) Believes that height and weight are relevant to their scope of 

practice, but blood pressure is not, is excluded from recording 

blood pressure; or 

(4) Believes that blood pressure is relevant to their scope of 

practice, but height and weight are not, is excluded from recording height and weight. 

Capability to exchange key clinical 

information (for example, problem 

list, medication list, medication allergies, and diagnostic test results), among providers of care 

and patient authorized entities 

electronically.

Change: Objective is no longer required ............................................... 2013—Onward (Required). 

Report ambulatory (hospital) clinical 

quality measures to CMS or the 

states.

Change: Objective is incorporated directly into the definition of a 

meaningful EHR user and eliminated as an objective under § 495.6.

2013—Onward (Required). 

EP and Hospital Objectives: Provide patients with an electronic 

copy of their health information 

(including diagnostics test results, 

problem list, medication lists, 

medication allergies, discharge 

summary, procedures) upon request.

Change: Replace these four objectives with the Stage 2 objective 

and one of the two Stage 2 measures..

2014—Onward (Required). 

EP Objective: Provide patients the ability to view online, download, 

and transmit their health information within 4 business days of the 

information being available to the EP..

EP Measure: More than 50 percent of all unique patients seen by the 

EP during the EHR reporting period are provided timely (within 4 

business days after the information is available to the EP) online 

access to their health information subject to the EP’s discretion to 

withhold certain information. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53979 

TABLE 4—STAGE 1 CHANGES—Continued 

Stage 1 objective Final changes Effective year 

(CY/FY) 

Hospital Objective: Provide patients 

with an electronic copy of their 

discharge instructions at time of 

discharge, upon request.

Hospital Objective: Provide patients the ability to view online, 

download, and transmit information about a hospital admission. 

EP Objective: Provide patients with 

timely electronic access to their 

health information (including lab 

results, problem list, medicatiion 

lists, and allergies) within 4 business days of the information 

being available to the EP..

Hospital Measure: More than 50 percent of all patients who are discharged from the inpatient or emergency department (POS 21 or 

23) of an eligible hospital or CAH have their information available 

online within 36 hours of discharge. 

Public Health Objectives: Change: Addition of ‘‘except where prohibited’’ to the objective regulation text for the public health objectives under § 495.6.2013—Onward (Required). 

Stage 1 Policy Changes 

Meeting an exclusion for a menu 

set objective counts towards the 

number of menu set objectives 

that must be satisfied to meet 

meaningful use.

Meeting an exclusion for a menu set objective does not count towards the number of menu set objectives that must be satisfied to 

meet meaningful use..

2014—Onward (Required). 

c. State Flexibility for Stage 2 of 

Meaningful Use 

We proposed to offer states flexibility 

under the Medicaid incentive program 

with the public health measures in 

Stage 2, similar to that of Stage 1, 

subject to the same conditions and 

standards as the Stage 1 flexibility 

policy. This applies to the public health 

measures as well as the measure to 

generate lists of specific conditions to 

use for quality improvement, reduction 

of disparities, research or outreach. We 

clarify that our proposal included the 

existing public health measures from 

Stage 1 as well as the new public health 

measures proposed for Stage 2. 

In addition, we stated that whether a 

state moved an objective to the core or 

left it in the menu, states may also 

specify the means of transmission of the 

data or otherwise change the public 

health measure, as long as it does not 

require EHR functionality above and 

beyond that which is included in the 

2014 ONC EHR certification criteria. 

We solicited comments on extending 

state flexibility as described for Stage 2 

of meaningful use and whether this 

remains a useful tool for state Medicaid 

agencies. 

Comment: Commenters requested 

clarification of the requirement that 

states cannot require EHR functionality 

above and beyond that which is 

included in the 2014 ONC EHR 

certification criteria. These commenters 

point out that the Stage 2 public health 

measures require capabilities beyond 

that which is included in the 2014 ONC 

EHR certification criteria already. 

Response: We assume commenters are 

referring to transmission methods which 

are not included in 2014 Edition EHR 

certification criteria adopted by ONC for 

public health objectives 

(immunizations, electronically 

reportable lab results, syndromic 

surveillance, cancer registries and 

specialized registries). This limitation 

applies only to those capabilities and 

standards included in 2014 ONC EHR 

certification criteria for a given public 

health objective. For example, a state 

could not require a different standard 

than the one included in 2014 ONC EHR 

certification criteria. In cases where the 

2014 ONC EHR certification criteria are 

silent, such as the means of 

transmission for a given public health 

objective, the state may propose changes 

to public health measures. 

Comment: Several commenters 

supported extending state flexibility 

with meaningful use for Stage 2, but 

requested that CMS provide a clearer 

definition of state flexibility. 

Commenters suggested that it would be 

helpful to EPs and eligible hospitals if 

states follow a common timeline for 

establishing state-specific requirements. 

Response: We appreciate these 

comments and would like to clarify that 

the state flexibility for Stage 2 remains 

defined the same way as it is defined in 

Stage 1 at § 495.316 (d)(2) and § 495.322 

(f)(2). Given that states are launching 

their programs at different times and are 

therefore at different stages in the 

program lifecycle and process, at this 

time we do not support the 

development of a common timeline for 

establishing state-specific requirements. 

The parameters remain the same as for 

Stage 1 and providers are subject to the 

requirements found in § 495.332. CMS 

approval of states’ requests will include 

a review of the outlined elements. 

After consideration of the public 

comments received, we are finalizing 

these provisions as proposed. 

d. Stage 2 Criteria for Meaningful Use 

(Core Set and Menu Set) 

We proposed to continue the Stage 1 

concept of a core set of objectives and 

a menu set of objectives for Stage 2. In 

the Stage 1 final rule (75 FR 44322), we 

indicated that for Stage 2, we expected 

to include the Stage 1 menu set 

objectives in the core set. We proposed 

to follow that approach for our Stage 2 

core set with two exceptions. We 

proposed to keep the objective of 

‘‘capability to submit electronic 

syndromic surveillance data to public 

health agencies’’ in the menu set for 

EPs. Our experience with Stage 1 is that 

very few public health agencies have the 

ability to accept non-emergency or non 

urgent care ambulatory syndromic 

surveillance data electronically and 

those that do are less likely to support 

EPs than hospitals; therefore we do not 

believe that current infrastructure 

supports moving this objective to the 

core set for EPs. We also proposed to 

keep the objective of ‘‘record advance 

directives’’ in the menu set for eligible 

hospitals and CAHs. As we stated in our 

Stage 1 final rule (75 FR 44345), we 

have continuing concerns that there are 

potential conflicts between storing 

advance directives and existing state 

laws. 

We proposed new objectives for Stage 

2, some of which would be part of the 

mstockstill on DSK4VPTVN1PROD with RULES2

53980 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

Stage 2 core set and others would make 

up the Stage 2 menu set, as discussed 

below with each objective. We proposed 

to eliminate certain Stage 1 objectives 

for Stage 2, such as the objective for 

testing the capability to exchange key 

clinical information. We proposed to 

combine some of the Stage 1 objectives 

for Stage 2. For example, the objectives 

of maintaining an up-to-date problem 

list, active medication list, and active 

medication allergy list would not be 

separate objectives for Stage 2. Instead, 

we proposed to combine these 

objectives with the objective of 

providing a summary of care record for 

each transition of care or referral by 

including them as required fields in the 

summary of care. 

We proposed a total of 17 core 

objectives and 5 menu objectives for 

EPs. We proposed that an EP must meet 

the criteria or an exclusion for all of the 

core objectives and the criteria for 3 of 

the 5 menu objectives. This is a change 

from our current Stage 1 policy where 

an EP could reduce the number of menu 

set objectives that the EP would 

otherwise need to meet by the number 

of menu set objectives that the EP could 

exclude. We noted the feedback we 

received on Stage 1 from providers and 

health care associations leads us to 

believe that most EPs had difficulty 

understanding the concept of deferral of 

a menu objective in Stage 1. Therefore, 

we proposed this change for Stage 2, as 

well as for Stage 1 beginning in 2014, to 

make the selection of menu objectives 

easier for EPs. We also proposed this 

change because we are concerned that 

under the current Stage 1 requirements 

some EPs could select and exclude 

menu objectives when there are other 

menu objectives they can legitimately 

meet, thereby making it easier for them 

to demonstrate meaningful use than EPs 

who attempt to legitimately meet the 

full complement of menu objectives. 

Although we provided the ability to do 

this in the selection of Stage 1 menu 

objectives through 2013, we stated that 

EPs participating in Stage 1 and Stage 2 

starting in 2014 should focus solely on 

those objectives they can meet rather 

than those for which they have an 

exclusion. In addition, we noted the 

exclusions for the Stage 2 menu 

objectives that we believe would 

accommodate EPs who are unable to 

meet certain objectives because of scope 

of practice. However, just as we signaled 

in our Stage 1 regulation, we stated our 

intent to propose in our next rulemaking 

that every objective in the menu set for 

Stage 2 (as described later in this 

section) be included in Stage 3 as part 

of the core set. 

We explained that in the case where 

an EP meets the criteria for the 

exclusions for 3 or more of the Stage 2 

menu objectives, the EP would have 

more exclusions than the allowed 

deferrals. EPs in this situation would 

attest to an exclusion for 1 or more 

menu objectives in his or her attestation 

to meaningful use. In doing so, the EP 

would be attesting that he or she also 

meets the exclusion criteria for all of the 

menu objectives that he or she did not 

choose. We stated that the same policy 

would also apply for the Stage 1 menu 

objectives for EPs beginning in 2014. 

We proposed a total of 16 core 

objectives and 4 menu objectives for 

eligible hospitals and CAHs for Stage 2. 

We proposed that an eligible hospital or 

CAH must meet the criteria or an 

exclusion for all of the core objectives 

and the criteria for 2 of the 4 menu 

objectives. We proposed that the policy 

for exclusions for EPs discussed in the 

preceding paragraph would also apply 

to eligible hospitals and CAHs for Stage 

1 beginning in 2014 and for Stage 2. 

We received many comments on the 

appropriateness of individual objectives 

placement in the core or menu set. We 

discuss these comments below for each 

individual objective. 

Comment: Commenters expressed 

concern over the small number of 

objectives in the menu set. They were 

concerned that the small number of 

objectives limited the usefulness of the 

menu set to providers. 

Response: Stage 2 does contain a more 

specialized and smaller menu set than 

Stage 1. We see this as a natural result 

of moving up the staged path towards 

improved outcomes and adding fewer 

new objectives. We also see 

specialization as necessary for 

meaningful use to be applicable to all 

EPs. Due to comments received we are 

adding two objectives for hospitals and 

one for EPs which will be in the menu, 

as further explained later in this section. 

After consideration of the public 

comments received, we finalize the 

concept of a core and menu set for Stage 

2. 

We finalize a total of 17 core 

objectives and 6 menu objectives for EPs 

for Stage 2. We finalize that an EP must 

meet the criteria or an exclusion for all 

of the core objectives and the criteria for 

3 of the 6 menu objectives unless an 

exclusion can be claimed for more than 

3 of the menu objectives in which case 

the criteria for the remaining nonexcluded objectives must be met. 

We finalize a total of 16 core 

objectives and 6 menu objectives for 

eligible hospitals and CAHs for Stage 2. 

We finalize that an eligible hospital or 

CAH must meet the criteria or an 

exclusion for all of the core objectives 

and the criteria for 3 of the 6 menu 

objectives. 

We also finalize our proposal to 

change the menu set exclusions policy 

for Stage 1. Beginning in 2014, 

qualifying for an exclusion from a menu 

set objective will no longer reduce the 

number of menu set objectives that an 

EP or hospital must otherwise satisfy to 

demonstrate meaningful use for Stage 1. 

There is an exception for EPs who meet 

the criteria to exclude five or more of 

the menu set objectives, in which case 

the EP must meet the criteria for all of 

the remaining non-excluded menu set 

objectives. This exception would not be 

applicable to hospitals due to the 

number of hospital menu set objectives 

that include exclusions. 

(1) Discussion of Whether Certain EPs, 

Eligible Hospitals or CAHs Can Meet All 

Stage 2 Meaningful Use Objectives 

Given Established Scopes of Practice 

We noted in the proposed rule that we 

do not believe that any of the proposed 

new objectives for Stage 2 make it 

impossible for any EP, eligible hospital 

or CAH to meet meaningful use. Where 

scope of practice may prevent an EP, 

eligible hospital or CAH from meeting 

the measure associated with an 

objective, we discussed the barriers and 

included exclusions in our descriptions 

of the individual objectives. We 

proposed to include new exclusion 

criteria when necessary for new 

objectives, continue the Stage 1 

exclusions for Stage 2, and continue the 

option for EPs and hospitals to defer 

some of the objectives in the menu set 

unless they meet the exclusion criteria 

for more objectives than they can defer 

as explained previously. 

We recognized in the proposed rule 

that at the time of publication, our data 

(derived internally from attestations) 

only reflected the meaningful use 

attestations from Medicare providers. 

There have been no significant changes 

in the data derived from meaningful use 

attestations since the publication of the 

proposed rule. 

We did not receive any comments on 

this provision. 

(2) EPs Practicing in Multiple Practices/ 

Locations 

We proposed for Stage 2 to continue 

our policy that to be a meaningful EHR 

user, an EP must have 50 percent or 

more of his or her outpatient encounters 

during the EHR reporting period at a 

practice/location or practices/locations 

equipped with CEHRT. An EP who does 

not conduct at least 50 percent of their 

patient encounters in any one practice/ 

location would have to meet the 50 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53981 

percent threshold through a 

combination of practices/locations 

equipped with CEHRT. We gave the 

following in the proposed rule example: 

if the EP practices at a federally 

qualified health center (FQHC) and 

within his or her individual practice at 

2 different locations, we would include 

in our review all 3 of these locations, 

and CEHRT would have to be available 

at one location or a combination of 

locations where the EP has 50 percent 

or more of his or her patient encounters. 

If CEHRT is only available at one 

location, then only encounters at this 

location would be included in 

meaningful use assuming this one 

location represents 50 percent or more 

of the EP’s patient encounters. If CEHRT 

is available at multiple locations that 

collectively represent 50 percent or 

more of the EP’s patient encounters, 

then all encounters from those locations 

would be included in meaningful use. 

In the proposed rule we stated that we 

have received many inquiries on this 

requirement since the publication of the 

Stage 1 final rule. We define patient 

encounter as any encounter where a 

medical treatment is provided and/or 

evaluation and management services are 

provided. This includes both 

individually billed events and events 

that are globally billed, but are separate 

encounters under our definition. We 

define a practice/location as equipped 

with CEHRT if the record of the patient 

encounter that occurs at that practice/ 

location is created and maintained in 

CEHRT. This can be accomplished in 

three ways: CEHRT could be 

permanently installed at the practice/ 

location, the EP could bring CEHRT to 

the practice/location on a portable 

computing device, or the EP could 

access CEHRT remotely using 

computing devices at the practice/ 

location. Although it is currently 

allowed under Stage 1 for an EP to 

create a record of the encounter without 

using CEHRT at the practice/location 

and then later input that information 

into CEHRT that exists at a different 

practice/location, we do not believe this 

process takes advantage of the value 

CEHRT offers. We proposed not to allow 

this practice beginning in 2013. We 

have also received inquiries whether the 

practice locations have to be in the same 

state, to which we clarify that they do 

not. Finally, we received inquiries 

regarding the interaction with hospitalbased EP determination. The 

determination of whether an EP is 

hospital-based or not occurs prior to the 

application of this policy, so only 

nonhospital-based eligible professionals 

are included. Furthermore, this policy, 

like all meaningful use policies for EPs, 

only applies to outpatient settings (all 

settings except the inpatient and 

emergency department of a hospital). 

Comment: Some commenters 

suggested that for EPs practicing in 

multiple locations that meaningful use 

attestations should be limited to just 

reporting on meaningful use for the 

most prevalent location due to the 

difficulty in aggregating data across 

locations. 

Response: We continue to believe that 

for the core measures, aggregating data 

is not overly burdensome. We allow the 

numerators and denominators 

calculated by CEHRT to be summed 

across an EP’s various practice 

locations. 

Comment: We received request for 

clarification on what to do when an EP 

is practicing in multiple locations that 

select different menu objectives to 

pursue, and the EP does not control this 

selection. 

Response: An EP who does not have 

the same menu objectives implemented 

across each of their practice locations 

equipped with CEHRT would attest to 

the three menu objectives that represent 

the greatest number of their patient 

encounters. For example, if six menu 

objectives are implemented between 

two locations, an EP would attest to the 

three menu objectives implemented at 

the location where they have the 

greatest number of encounters during 

the EHR reporting period. For measures 

that utilize a percentage threshold, they 

can limit the denominator to the 

location or locations that pursued that 

menu objective. 

After consideration of the public 

comments received, we are finalizing 

the proposed provisions with the 

modifications previously discussed. 

(3) Discussion of the Reporting 

Requirements of the Measures 

Associated With the Stage 2 Meaningful 

Use Objectives 

In our experience with Stage 1, we 

found the distinction between limiting 

the denominators of certain measures to 

only those patients whose records are 

maintained using CEHRT, but including 

all patients in the denominators of other 

measures, to be complicated for 

providers to implement. We proposed to 

remove this distinction for Stage 2 and 

instead include all patients in the 

denominators of all of the measures 

associated with the meaningful use 

objectives for Stage 2. We believe that 

by the time an EP, eligible hospital, or 

CAH has reached Stage 2 of meaningful 

use all or nearly all of their patient 

population should be included in their 

CEHRT, making this distinction no 

longer relevant. 

Comment: We received comments 

that maintain that this distinction is still 

necessary for Stage 2 because there are 

situations where significant patient 

records may still be maintained outside 

of CEHRT. Examples provided by 

commenters include worker’s 

compensation or other special contracts 

for certain patients, specialized 

departments or units in a hospital for 

which CEHRT is not tailored and 

patient requests to keep their records on 

paper. 

Response: We continue to believe that 

nearly all patient records will be stored 

in CEHRT by the time a provider 

reaches Stage 2. However, we 

acknowledge that if this assertion is 

correct then there is no practical 

consequence of maintaining the 

distinction, while if it is not, removing 

the distinction could have adverse 

impacts on providers. 

After consideration of the comments, 

we are not finalizing our proposed 

change. Instead, we maintain the 

distinction between measures that 

include only those patients whose 

records are maintained using CEHRT 

and measures that include all patients. 

Providers may limit the denominator to 

those patients whose records are 

maintained using CEHRT for measures 

with a denominator other than unique 

patients seen by the EP during the EHR 

reporting period or unique patients 

admitted to the eligible hospital’s or 

CAH’s inpatient or emergency 

department during the EHR reporting 

period. 

Comment: Some commenters 

suggested that the denominators should 

be limited to either just Medicarecovered patients for those participating 

in the Medicare EHR Incentive Program 

or just Medicaid-covered patients for 

those participating in the Medicaid EHR 

Incentive Program. Commenters 

presented two arguments in favor of this 

suggestion. First, that requiring a 

provider to include all patients was 

more burdensome than including just 

Medicare-covered or Medicaid-covered 

patients and that this burden was not 

offset by the incentive payments that are 

based (for Medicare only) on charges 

submitted to Medicare. Second, that if 

identifiable patient data was included in 

Medicare or Medicaid meaningful use 

reporting for patient not covered by 

Medicare or Medicaid this would raise 

serious privacy concerns and possibly 

require patient consent. Other 

commenters were supportive of current 

denominators that does not account for 

payers. 

mstockstill on DSK4VPTVN1PROD with RULES2

53982 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

Response: We discussed the burden 

differences between all patients versus 

patients differentiated by payer in our 

Stage 1 final rule (75 FR44332). We 

continue to believe that it is highly 

unlikely that providers will use 

different record keeping systems based 

on payer. Where there are differences in 

patient populations such as age we 

account for them directly in the measure 

not indirectly with payer as a 

generalized proxy. The burden of 

breaking out the patients by payer for 

purposes of meaningful use 

measurement would have only 

increased from the publication of the 

Stage 1 final rule as measurement tools 

have been designed and implemented to 

measure patients regardless of payer. If 

at a future date, the demonstration of 

meaningful use includes the submission 

of identifiable patient data we will 

certainly address the privacy 

implications of that requirement. 

However, the Stage 1 objectives and 

measures and Stage 2 objectives and 

measures included in this final rule do 

not require the submission of 

identifiable patient information. We are 

not making any changes to this policy 

in this final rule. 

We proposed new objectives that 

could increase reporting burden. To 

minimize the burden, we proposed to 

create a uniform set of denominators 

that would be used for all of the Stage 

2 meaningful use objectives, as 

discussed later. 

Many of our meaningful use 

objectives use percentage-based 

measures if appropriate. To provide a 

check on the burden of reporting of 

meaningful use, we proposed for Stage 

2 to use 1 of 4 denominators for each of 

the measures associated with the 

meaningful use objectives. We focused 

on denominators because the action that 

moves something from the denominator 

to the numerator usually requires the 

use of CEHRT by the provider. These 

actions are easily tracked by the 

technology. 

The four proposed denominators for 

EPs are— 

• Unique patients seen by the EP 

during the EHR reporting period 

(stratified by age or previous office 

visit); 

• Number of orders (medication, labs, 

radiology); 

• Office visits, and 

• Transitions of care/referrals. 

Comment: We received many 

comments supporting our efforts to 

minimize the variety of denominators. 

Some commenters argued that any 

variation (such as by age or orders of 

different types) should be considered 

separate denominators. 

Response: We appreciate the support 

for our proposal to minimize the variety 

of denominators. Our base of four 

denominators are only modified by 

information that must be entered into 

CEHRT in order to meet meaningful use; 

therefore, we believe that such 

modifications represent a small burden 

and are in keeping with our overall goal 

in minimizing the variety of 

denominators. 

In the proposed rule, we stated that 

the term ‘‘unique patient’’ means that if 

a patient is seen or admitted more than 

once during the EHR reporting period, 

the patient only counts once in the 

denominator. Patients seen or admitted 

only once during the EHR reporting 

period will count once in the 

denominator. A patient is seen by the 

EP when the EP has an actual physical 

encounter with the patient in which 

they render any service to the patient. 

A patient seen through telemedicine 

will also still count as a patient ‘‘seen 

by the EP.’’ In cases where the EP and 

the patient do not have an actual 

physical or telemedicine encounter, but 

the EP renders a minimal consultative 

service for the patient (like reading an 

EKG), the EP may choose whether to 

include the patient in the denominator 

as ‘‘seen by the EP’’ provided the choice 

is consistent for the entire EHR 

reporting period and for all relevant 

meaningful use measures. For example, 

a cardiologist may choose to exclude 

patients for whom they provide a onetime reading of an EKG sent to them 

from another provider, but include more 

involved consultative services as long as 

the policy is consistent for the entire 

EHR reporting period and for all 

meaningful use measures that include 

patients ‘‘seen by the EP.’’ EPs who 

never have a physical or telemedicine 

interaction with patients must adopt a 

policy that classifies at least some of the 

services they render for patients as 

‘‘seen by the EP,’’ and this policy must 

be consistent for the entire EHR 

reporting period and across meaningful 

use measures that involve patients 

‘‘seen by the EP’’—otherwise, these EPs 

will not be able to satisfy meaningful 

use, as they will have denominators of 

zero for some measures. In cases where 

the patient is seen by a member of the 

EP’s clinical staff the EP can include or 

not include those patients in their 

denominator at their discretion as long 

as the decision applies universally to all 

patients for the entire EHR reporting 

period and the EP is consistent across 

meaningful use measures. In cases 

where a member of the EP’s clinical staff 

is eligible for the Medicaid EHR 

incentive in their own right (for 

example, nurse practitioners (NPs) and 

certain physician assistants (PA)), 

patients seen by NPs or PAs under the 

EP’s supervision can be counted by both 

the NP or PA and the supervising EP as 

long as the policy is consistent for the 

entire EHR reporting period. 

Comment: While generally supporting 

the concept of a unique patient as a 

good tool to address the fact that not all 

meaningful use objectives need be 

addressed at every patient encounter or 

rendering of medical service, some 

commenters expressed concern about 

the ability to identify unique patients 

across CEHRTs in situations where an 

EP practices at multiple locations or in 

situations where an EP might switch 

CEHRT during an EHR reporting period. 

Response: We agree that determining 

unique patients across CEHRTs is 

difficult. When aggregating performance 

on meaningful use measures across 

multiple practice locations using 

different CEHRTs we do not require that 

it be determined that a patient seen at 

one location was not also seen at 

another location. While this could result 

in the same patient appearing more than 

once in the denominator of unique 

patients seen, we believe that the 

burden of seeking out these patients is 

greater than any gain in measurement 

accuracy. Furthermore, it is not possible 

for a provider to increase only the 

numerator with this policy as any 

increase in the numerator would also 

increase the denominator. Accordingly, 

we are adopting a final policy that will 

give EPs who practice at multiple 

locations or switch CEHRT during the 

EHR reporting period some flexibility as 

to the method for counting unique 

patients in the denominators. We leave 

it up to the EP to decide for the EHR 

reporting period whether to count a 

unique patient across all locations 

equipped with different CEHRT (for 

example, 1 patient seen at 3 locations 

with different CEHRT counts once) or at 

each location equipped with CEHRT (for 

example, 1 patient seen at 3 locations 

with different CEHRT counts thrice). In 

cases where a provider switches CEHRT 

products at a single location during the 

EHR reporting period, they also have the 

flexibility to count a patient as unique 

on each side of the switch and not 

across it (for example, 1 patient seen 

before the switch and after the switch 

could be counted once or twice). EPs in 

these scenarios must choose one of 

these methods for counting unique 

patients and apply it consistently 

throughout the entire EHR reporting 

period. 

With the flexibility for EPs practicing 

in multiple locations using different 

CEHRT or switching CEHRT during the 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53983 

EHR reporting period, we otherwise 

finalize our description of ‘‘unique 

patient’’ as proposed. 

We proposed that an office visit is 

defined as any billable visit that 

includes: (1) Concurrent care or transfer 

of care visits; (2) consultant visits; or (3) 

prolonged physician service without 

direct, face-to-face patient contact (for 

example, telehealth). A consultant visit 

occurs when a provider is asked to 

render an expert opinion/service for a 

specific condition or problem by a 

referring provider. The visit does not 

have to be individually billable in 

instances where multiple visits occur 

under one global fee. 

Comment: We received comments 

requesting that we establish a list of 

billing codes that constitute an office 

visit for purposes of clarity. 

Response: We continue to believe that 

the use of a list of billing codes would 

inappropriately limit the discretion of 

EPs that we have built into this 

measure. We finalize as proposed our 

description of an office visit and 

emphasize that there is room for EP 

discretion in this definition and that the 

most important consideration in 

utilizing that discretion is that the 

policy apply for the entire EHR 

reporting period and across all patients. 

We proposed to describe transitions of 

care as the movement of a patient from 

one setting of care (hospital, ambulatory 

primary care practice, ambulatory 

specialty care practice, long-term care, 

home health, rehabilitation facility) to 

another. Currently, the meaningful use 

measures that use transitions of care 

require there to be a receiving provider 

of care to accept the information. 

Therefore, a transition home without 

any expectation of follow-up care 

related to the care given in the prior 

setting by another provider is not a 

transition of care for purpose of Stage 2 

meaningful use measures as there is no 

provider recipient. A transition within 

one setting of care does not qualify as 

a transition of care. Referrals are cases 

where one provider refers a patient to 

another, but the referring provider 

maintains their care of the patient as 

well. Please note that a ‘‘referral’’ as 

defined here and elsewhere in this final 

rule is only intended to apply to the 

EHR Incentive Programs and is not 

applicable to other Federal regulations. 

Comment: We have received many 

comments that determining when a 

transition of care occurs is very difficult 

under our current Stage 1 rule, 

particularly when the provider is on the 

receiving end of the transition of care. 

Commenters suggest that the only 

reliable way to know if a patient saw 

another provider is to ask the patient at 

each encounter and even then this is not 

guaranteed. Several suggestions were 

presented to make the definition more 

precise on both the receiving and 

transitioning side. They were as 

follows:— 

• Discharges for eligible hospitals/ 

CAHs and referrals to other providers 

who do not share the same CEHRT as 

the EP are very clearly identified and 

should be the focus of the numerator/ 

denominator. 

• A transition within one setting of 

care does not qualify as a transition of 

care. Referral is defined as care ‘‘where 

one provider refers a patient to another, 

but the referring provider maintains 

their care of the patient as well.’’ 

• A patient is referred to another 

provider (for EPs) or a patient is 

discharged (for eligible hospitals). 

• Sharing data with health plans. 

Response: In reviewing the comments, 

we agree that a refinement of our 

transitions of care definition is needed. 

We also agree with the suggestions to 

point to specific events that identify a 

transition of care has occurred without 

relying entirely on asking the patient. 

Therefore, we revise our description of 

transitions of care for the purpose of 

defining the denominator. For an EP 

who is on the receiving end of a 

transition of care or referral, (currently 

used for the medication reconciliation 

objective and measure), the 

denominator includes first encounters 

with a new patient and encounters with 

existing patients where a summary of 

care record (of any type) is provided to 

the receiving provider. The summary of 

care record can be provided either by 

the patient or by the referring/transiting 

provider or institution. We believe that 

both of these situations would create 

information in the CEHRT that can be 

automatically recorded. For an EP who 

is initiating a patient transfer to another 

setting and/or referring a patient to 

another provider, (currently used for 

providing summary of care documents 

at transitions of care), the initiating/ 

referring EP would count the transitions 

and/or referrals that were ordered by the 

EP in the measure denominator. If 

another provider also sees the same 

patient, only the EP who orders the 

transition/referral would need to 

account for this transition for the 

purpose of this measure. EPs are not 

responsible for including patientinitiated transitions and referrals that 

were not ordered by the EP. For 

example, if the EP creates an order for 

admission to a nursing home, this 

transition of care would be counted in 

the EP’s measure denominator. If one of 

the EP’s patients is admitted to a 

nursing home by another provider, this 

transition would only have to be 

counted by the EP who creates the order 

and not necessarily by other EPs who 

care for the patient. We want to 

emphasize that these transitions of care/ 

referral descriptions have been 

developed for purposes of reducing the 

provider measurement burden for the 

EHR Incentive Program and do not 

necessarily apply to other programs or 

regulations. We also clarify that these 

descriptions are minimum 

requirements. An EP can include in the 

denominator transitions of care and 

referrals that fit the broader descriptions 

of these terms, but are not one of the 

specific events described previously. 

The four proposed denominators for 

eligible hospitals and CAHs are— 

• Unique patients admitted to the 

eligible hospital’s or CAH’s inpatient or 

emergency department during the EHR 

reporting period (stratified by age); 

• Number of orders (medication, labs, 

radiology); 

• Inpatient bed days; and 

• Transitions of care. 

We noted in the proposed rule that 

our explanation of ‘‘unique patients’’ 

and ‘‘transitions of care’’ for EPs would 

also apply for eligible hospitals and 

CAHs. 

Comment: Commenters suggested a 

problem with unique patients could 

arise if a hospital switched CEHRT 

during the EHR reporting period. 

Response: Our final policy on EPs 

who switch CEHRT during the EHR 

reporting period counting unique 

patients in the denominator would also 

apply for hospitals in the same 

situation. 

Comment: We have received many 

comments that determining when a 

transition of care occurs is very difficult 

under our Stage 1 regulations, 

particularly when the provider is on the 

receiving end of the transition of care. 

Commenters suggest that the only 

reliable way to know if a patient saw 

another provider is to ask the patient at 

each encounter and even then this is not 

guaranteed. Several suggestions were 

presented to make the definition more 

precise on both the receiving and 

transitioning side, which we 

summarized previously in the 

discussion of the proposed 

denominators for EPs. 

Response: For the same reasons as 

discussed for EPs, we agree that 

pointing to specific occurrences is 

needed to accurately measure this 

denominator. For transitions of care 

when the hospital is on the receiving 

end, (currently used for the medication 

reconciliation objective and measure), 

we include all admissions to the 

inpatient and emergency departments. 

mstockstill on DSK4VPTVN1PROD with RULES2

53984 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

For transitions of care when the hospital 

is transitioning the patient, (currently 

used for providing summary of care 

documents at transitions of care), we 

include all discharges from the inpatient 

department and after admissions to the 

emergency department when follow-up 

care is ordered by an authorized 

provider of the hospital. As with EPs, 

these are the minimum events that must 

be included in the denominator for the 

transitions of care measure. Hospitals 

can include additional transitions of 

care that match the full description of 

transitions of care, but are not one of 

these specific events. 

We proposed that admissions to the 

eligible hospital or CAH can be 

calculated using one of two methods 

currently available under Stage 1 of 

meaningful use. The observation 

services method includes all patients 

admitted to the inpatient department 

(POS 21) either directly or through the 

emergency department and patients 

who initially present to the emergency 

department (POS 23) and receive 

observation services. Details on 

observation services can be found in the 

Medicare Benefit Policy Manual, 

Chapter 6, Section 20.6. Patients who 

receive observation services under both 

the outpatient department (POS 22) and 

emergency department (POS 23) should 

be included in the denominator under 

this method. The all emergency 

department method includes all patients 

admitted to the inpatient department 

(POS 21) either directly or through the 

emergency department and all patients 

receiving services in the emergency 

department (POS 23). 

Comment: Commenters expressed 

near universal support for the 

continuance of the two options in 

defining an admission to the emergency 

department. 

Response: We continue to believe that 

not all information required by 

meaningful use may be relevant to all 

encounters in the emergency 

department and that this decision is best 

left to the hospital; therefore, we are 

finalizing this as proposed. 

We proposed that inpatient bed days 

are the admission day and each of the 

following full 24-hour periods during 

which the patient is in the inpatient 

department (POS 21) of the hospital. For 

example, a patient admitted to the 

inpatient department at noon on June 

5th and discharged at 2 p.m. on June 7th 

will be admitted for 2-patient days: the 

admission day (June 5th) and the 24 

hour period from 12 a.m. on June 6th to 

11:59 p.m. on June 6th. 

We did not receive comments on this 

proposal. This denominator is not used 

by the proposed meaningful use 

objectives and measures nor the 

finalized objectives and measures. 

As discussed later in this section, we 

are including the menu objective for 

hospitals of ‘‘Provide structured 

electronic lab results to ambulatory 

providers’’. The measure associated 

with the objective uses a denominator 

that was not included in our proposal. 

The denominator is the number of 

electronic lab orders received by the 

hospital from ambulatory providers. For 

this objective, we use the same 

description of ‘‘laboratory services’’ as 

for our Stage 2 CPOE objective: any 

service provided by a laboratory that 

could not be provided by a 

nonlaboratory. We also use the 

definition of ‘‘laboratory’’ at § 493.2 as 

for the Stage 2 CPOE objective. Any 

order for a laboratory service will be 

considered a lab order. For the order to 

be considered received electronically, it 

must be received by the hospital 

utilizing an electronic transmission 

method and not through methods such 

as physical electronic media, electronic 

fax, paper document or telephone call. 

After consideration of public 

comments, we are finalizing the 

following denominators for EPs: 

• Unique patients seen by the EP 

during the EHR reporting period 

(stratified by age or previous office 

visit); 

• Number of orders (medication, labs, 

radiology); 

• Office visits; and 

• Transitions of care/referrals 

including at a minimum one of the 

following: 

+ + When the EP is the recipient of 

the transition or referral, first 

encounters with a new patient and 

encounters with existing patients where 

a summary of care record (of any type) 

is provided to the receiving EP; 

++ When the EP is the initiator of the 

transition or referral, transitions and 

referrals ordered by the EP. 

We are finalizing the following 

denominators for eligible hospitals and 

CAHs: 

• Unique patients admitted to the 

eligible hospital’s or CAH’s inpatient or 

emergency department during the EHR 

reporting period (stratified by age); 

• Number of orders (medication, labs, 

radiology); 

• Transitions of care including at a 

minimum one of the following: 

++ When the hospital is the recipient 

of the transition or referral, all 

admissions to the inpatient and 

emergency departments, 

++ When the hospital is the initiator 

of the transition or referral, all 

discharges from the inpatient 

department and after admissions to the 

emergency department when follow-up 

care is ordered by authorized providers 

of the hospital; and 

• Electronic lab orders received by 

the hospital from ambulatory providers. 

(4) Discussion of the Relationship of 

Meaningful Use to CEHRT 

We proposed to continue our policy 

of linking each meaningful use objective 

to certification criteria for CEHRT. As 

with Stage 1, EPs, eligible hospitals, and 

CAHs must use the capabilities and 

standards that are certified to meet the 

objectives and associated measures for 

Stage 2 of meaningful use. In meeting 

any objective of meaningful use, an EP, 

eligible hospital or CAH must use the 

capabilities and standards that are 

included in certification. We noted that 

in some instances, meaningful use 

objectives and measures require use that 

is not directly enabled by certified 

capabilities and/or standards. In these 

cases, the EP, eligible hospital and CAH 

is responsible for meeting the objectives 

and measures of meaningful use, but the 

way they do so is not constrained by the 

capabilities and standards of CEHRT. In 

the proposed rule we gave the following 

example: in e-Rx and public health 

reporting, CEHRT applies standards to 

the message being sent and enables 

certain capabilities for transmission in 

2014; however, to actually engage in eRx or public health reporting many 

steps must be taken outside of these 

standards and capabilities such as 

contacting both parties and 

troubleshooting issues that may arise 

through the normal course of business. 

Comment: We received many 

comments that expressed confusion of 

when the capabilities and standards 

included in certification must be used 

and when they do not. 

Response: Nearly all of these 

comments were objective-specific, so we 

address them at the referenced 

objective. With each measure we 

include a universal statement on the 

applicability of the specific standards 

and capabilities included in the 2014 

edition of certification criteria for EHR 

technologies and, if applicable, specific 

allowances for that measure. 

After consideration of the public 

comments received, we are finalizing 

these provisions as proposed. 

(5) Discussion of the Relationship 

Between a Stage 2 Meaningful Use 

Objective and Its Associated Measure 

We proposed to continue our Stage 1 

policy that regardless of any actual or 

perceived gaps between the measure of 

an objective and full compliance with 

the objective (such as a measure 

threshold of less than 100 percent or a 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53985 

measure designed to account for 

circumstances where 100 percent 

compliance in not the intention of the 

objective), meeting the criteria of the 

measure means that the provider has 

met the objective for Stage 2. 

We did not receive any comments and 

we are finalizing these provisions as 

proposed. 

(6) Objectives and Their Associated 

Measures 

(a) Objectives and Measures Carried 

Over (Modified or Unmodified) From 

Stage 1 Core Set to Stage 2 Core Set 

Proposed Objective: Use 

computerized provider order entry 

(CPOE) for medication, laboratory and 

radiology orders directly entered by any 

licensed healthcare professional who 

can enter orders into the medical record 

per state, local and professional 

guidelines to create the first record of 

the order. 

In the proposed rule, we outlined the 

following benefits of CPOE. CPOE 

improves quality and safety by allowing 

clinical decision support at the point of 

the order and therefore influences the 

initial order decision. CPOE improves 

safety and efficiency by automating 

aspects of the ordering process to reduce 

the possibility of communication and 

other errors. Consistent with the 

recommendations of the HIT Policy 

Committee, we proposed to expand the 

orders included in the objective to 

medication (which was included in 

Stage 1), laboratory, and radiology. We 

believe that the expansion to laboratory 

and radiology furthers the goals of the 

CPOE objective, that such orders are 

commonly included in CPOE roll outs 

and that inclusion of the entry of these 

orders using CPOE is a logical step in 

the progression of meaningful use. We 

note that this does not require the 

electronic transmission of the order. 

We proposed to continue to define 

CPOE as the provider’s use of computer 

assistance to directly enter medical 

orders (for example, medications, 

consultations with other providers, 

laboratory services, imaging studies, and 

other auxiliary services) from a 

computer or mobile device. The order is 

then documented or captured in a 

digital, structured, and computable 

format for use in improving safety and 

efficiency of the ordering process. We 

further proposed that the CPOE function 

of CEHRT must be used by the ordering 

provider or licensed healthcare 

professionals under his or her direction 

to create the first record of that order, 

or it would not count as CPOE. As this 

proposed objective limits the use of 

CPOE to the creation of the first record 

of the order (a more restrictive standard 

than in Stage 1), we invited public 

comment on whether the stipulation 

that the CPOE function be used only by 

licensed healthcare professionals 

remains necessary or if CPOE can be 

expanded to include non-licensed 

healthcare professionals such as scribes. 

Comment: Commenters focused 

primarily on CPOE’s value as the trigger 

for clinical decision support 

interventions. It was suggested the term 

be revised from computerized provider 

order entry to computerized order 

evaluation. This focus led to the 

suggestion by several commenters that 

as long as the ordering providers 

‘‘signs’’ or otherwise authorizes the 

order before it is carried out this should 

count for CPOE. These commenters 

maintain that meaningful use should 

not dictate any of the processes that lead 

up to this authorization including who 

enters the order into CEHRT nor what 

types of record of the order may exist 

prior to entry into CEHRT. 

Response: We agree that CPOE as the 

trigger for CDS interventions is the 

primary value creating function of 

CPOE. However, we disagree that it is 

the only one. We believe automating 

aspects of and/or eliminating steps in 

the ordering process prior to final 

authorization of the order does reduce 

communication and other errors. 

Furthermore, it is our understanding 

from both commenters and our own 

experiences with CEHRT that many 

EHRs use the entry of the order as the 

trigger for CDS interventions and either 

display them again at authorization or 

do not display them at all at 

authorization. For these reasons, we 

continue to focus the definition and 

measurement of CPOE on when and by 

whom the order is entered into CEHRT 

and not on when it is authorized by the 

ordering provider in CEHRT. 

Comment: Commenters stated that the 

authentication of verbal orders is 

already covered by the conditions of 

participation for hospitals at 42 

CFR482.24(c)(1)(iii) which states that 

‘‘[a]ll verbal orders must be 

authenticated based upon Federal and 

state law. If there is no state law that 

designates a specific timeframe for the 

authentication of verbal orders, verbal 

orders must be authenticated within 48 

hours.’’ Meaningful use should adopt 

this same standard. 

Response: We are not adopting this 

standard for two reasons. First, as this 

is in an incentive program, we do not 

believe it is logical to base a 

requirement for meaningful use solely 

on a condition of participation. 

Hospitals already must comply with the 

conditions of participation, so we 

believe as an incentive program 

meaningful use should be incentivizing 

behavior beyond the conditions of 

participation. Second, as discussed 

later, we are not limiting the 

communication of orders prior to CPOE 

to verbal orders so there is not a direct 

corollary between this condition of 

participation and our description of 

CPOE. Section 482.23(c)(2) also speaks 

to verbal orders. First, it states, ‘‘If 

verbal orders are used, they are to be 

used infrequently. Second, it states, 

‘‘When verbal orders are used, they 

must only be accepted by persons who 

are authorized to do so by hospital 

policy and procedures consistent with 

Federal and state law.’’ We discuss who 

may enter the order later in comment 

and response, but reiterate our position 

that meaningful use should incentivize 

behavior that benefits patients beyond 

that required by the conditions of 

participation. 

Comment: Commenters objected to 

our proposal to change our policy 

regarding CPOE from ‘‘the CPOE 

function should be used the first time 

the order becomes part of the patient’s 

medical record and before any action 

can be taken on the order’’ to ‘‘the order 

created using the EHR must be the first 

record of that order or it would not 

count as CPOE’’. The commenters 

stressed that if they used a process that 

created a record of the order that was 

not part of the patient’s medical record, 

then the proposed policy requiring this 

record not be retained is not advisable. 

The commenters asserted that even if it 

was not part of the patient’s medical 

record the initial record of the order 

could be used for quality control 

purposes. 

Response: Our proposed policy 

change was intended as an evolution 

from the Stage 1 requirements for CPOE. 

However, after reviewing the comments 

received, we agree that requiring an 

electronic or written order that is not 

created using the CPOE function of 

CEHRT to not be retained in order for 

it to count as CPOE could have 

unforeseen and possibly detrimental 

consequences for quality control. We 

continue to believe that our original 

proposal would have increased CPOE’s 

ability to improve safety and efficiency 

and encourage all providers to 

streamline the ordering process to 

minimize the number of steps involved. 

However, we do not have sufficient 

information to determine whether the 

gains of the proposal are greater than or 

less than the potential cost of not 

retaining written or electronic orders 

issued before the use of the CPOE 

function. Therefore, we are not 

finalizing the proposed revised 

mstockstill on DSK4VPTVN1PROD with RULES2

53986 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

description of when the CPOE function 

must be utilized during the ordering 

process and instead finalize our existing 

Stage 1 description that the CPOE 

function should be used the first time 

the order becomes part of the patient’s 

medical record and before any action 

can be taken on the order. Based on the 

questions we have received on CPOE to 

date, the limiting criterion is the first 

time the order becomes part of the 

patient’s medical record rather than the 

limitation of before any action can be 

taken on the order. The provider must 

make the determination as to what 

constitutes the patient’s medical record 

and what does not based on their 

existing policies and applicable state 

and Federal law. Our only requirements 

in this regard are that the determination 

be made by the provider prior to the 

start of the EHR reporting period and be 

uniformly applied. 

Comment: We have received many 

comments on who can enter the order 

into CEHRT for it to count as CPOE. 

Four possibilities received comment 

support. First, only the ordering 

provider be able to enter the order into 

CEHRT. Second, any licensed 

healthcare professional who can enter 

orders into the medical record per state, 

local and professional guidelines can 

enter the order into CEHRT. This is the 

current policy which was proposed to 

continue. Third, an expansion to any 

licensed, certified or appropriately 

credentialed healthcare professional 

(some commenters replaced medical 

assistant with healthcare professional) 

who can enter orders into the medical 

record per state, local and professional 

guidelines. Fourth, an expansion to 

allow anyone, including those 

commonly referred to as scribes, enter 

the orders into the medical record per 

state, local and professional guidelines. 

We also note that there was some 

confusion among commenters as to our 

current limitation and proposal of any 

licensed healthcare professional using 

CPOE to create the first entry of the 

order into the patient’s medical record 

as we received many comments 

suggesting that nurses should be able to 

enter the orders. We clarify that nurses 

who are licensed and can enter orders 

into the medical record per state, local 

and professional guidelines may enter 

the order into CEHRT and have it count 

as CPOE. 

Response: As we did not revise our 

description of when in the ordering 

process the CPOE function must be 

used, we are inclined to not revise our 

description of who may enter it into 

CEHRT. However, we are particularly 

concerned with CPOE usage by EPs in 

this regard. Many EPs practice without 

the assistance of other licensed 

healthcare professionals. These EPs in 

their comments urged the expansion 

indicated in the third possibility of 

credentialed healthcare professionals/ 

medical assistants. We believe that this 

expansion is warranted and protects the 

concept that the CDS interventions will 

be presented to someone with medical 

knowledge as opposed to a layperson. 

The concept of credentialed healthcare 

professionals is over broad and could 

include an untold number of people 

with varying qualifications. Therefore, 

we finalize the more limited description 

of including credentialed medical 

assistants. The credentialing would 

have to be obtained from an 

organization other than the employing 

organization. Our responses to earlier 

comments factored into this decision as 

well. Based on the public comments 

received, questions submitted by the 

public on Stage 1 and demonstrations of 

CEHRT we have participated in, it is 

apparent that the prevalent time when 

CDS interventions are presented is 

when the order is entered into CEHRT, 

and that not all EHRs also present CDS 

when the order is authorized (assuming 

such a multiple step ordering process is 

in place). This means that the person 

entering the order could be required to 

enter the order correctly, evaluate CDS 

either using their own judgment or 

through accurate relay of the 

information to the ordering provider, 

and then either make a change to the 

order based on the CDS intervention or 

bypass the intervention. We do not 

believe that a layperson is qualified to 

do this, and as there is no licensing or 

credentialing of scribes, there is no 

guarantee of their qualifications. 

Comment: We received comments on 

a particular category of orders referred 

to as ‘‘protocol’’ or ‘‘standing’’ orders. 

The defining characteristic of these 

orders is that they are not created due 

to a specific clinical determination by 

the ordering provider for a given 

patient, but rather are pre-determined 

for patients with a given set of 

characteristics (for example, administer 

medication X and order lab Y for all 

patients undergoing a certain procedure 

or refills for given medication). 

Commenters maintain that these orders 

require special treatment in regards to 

when they are entered into CEHRT and 

who enters them. Commenters indicate 

that administrative staff should be 

allowed to enter them, but not override 

any CDS interventions that may appear. 

Response: We agree that this category 

of orders warrant different 

considerations than orders that are due 

to a specific clinical determination by 

the ordering provider for a specific 

patient. We therefore allow providers to 

exclude orders that are predetermined 

for a given set of patient characteristics 

or for a given procedure from the 

calculation of CPOE numerators and 

denominators. Note this does not 

require providers to exclude this 

category of orders from their numerator 

and denominator. We foresee two 

circumstances where a provider would 

not want to exclude this category of 

orders. The first is that they disagree 

that these type of orders warrant 

different considerations and therefore 

enter them according to our description 

of CPOE. The second is providers who 

are unable to separate them from other 

orders in their calculation of the 

denominator and numerator. 

Comment: Commenters mostly 

support the expansion to the laboratory 

and radiology orders. Three concerns 

were raised. First, commenters believed 

that as laboratory and radiology orders 

were new additions they should have a 

lower threshold than medication orders. 

Second, commenters desired a more 

descriptive definition on what 

constitutes a laboratory and particularly 

a radiology order. Third, commenters 

suggested that laboratory and radiology 

orders should be delayed for EPs until 

more laboratory and radiology providers 

could receive the order electronically. 

Response: We discuss the measure 

separately later in this section and 

address the comments on the threshold 

there. We describe laboratory services as 

any service provided by a laboratory 

that could not be provided by a nonlaboratory. Laboratory is defined at 42 

CFR 493.2 as: ‘‘a facility for the 

biological, microbiological, serological, 

chemical, immunohematological, 

hematological, biophysical, cytological, 

pathological, or other examination of 

from the human body for the purpose of 

providing information for the diagnosis, 

prevention, or treatment of any disease 

or impairment of, or the assessment of 

the health of, human beings. These 

examinations also include procedures to 

determine, measure, or otherwise 

describe the presence or absence of 

various substances or organisms in the 

body. Facilities only collecting or 

preparing specimens (or both) or only 

serving as a mailing service and not 

performing testing are not considered 

laboratories.’’ We describe radiologic 

services as any imaging service that uses 

electronic product radiation. Electronic 

product radiation is defined at 21 CFR 

1000.3 as: ‘‘any ionizing or nonionizing 

electromagnetic or particulate radiation, 

or [a]ny sonic, infrasonic, or ultrasonic 

wave that is emitted from an electronic 

product as the result of the operation of 

an electronic circuit in such product.’’ 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53987 

If the provider desires to include other 

types of imaging services that do not 

rely on electronic product radiation they 

may do so as long as the policy is 

consistent across all patients and for the 

entire EHR reporting period. Finally, as 

we discuss in the next comment and 

response, electronic transmission of the 

order is not a requirement for CPOE. 

Comment: Some commenters stated 

that while CPOE is a commonly 

understood function in the hospital 

setting, in the ambulatory setting its use 

is more ambiguous. For medication 

orders, the difference between CPOE for 

the medication and e-prescribing the 

medication is more subtle. The 

expansion to laboratory and radiology 

further complicates this in the 

ambulatory setting as most laboratory 

and radiology orders are sent to a third 

party which may or may not be able to 

receive such orders electronically. 

Response: While we agree that the 

concept of CPOE is a more definitive 

action in the ordering process in the 

hospital setting, we believe that it is still 

integral to the ambulatory setting and 

serves the same purposes in both 

settings as a trigger for CDS 

interventions and as a way to increase 

the efficiency and safety of the ordering 

process. CPOE is the entry of the order 

into the patient’s EHR that uses a 

specific function of CEHRT. It is not 

how that order is filled or otherwise 

carried out. For medications, on the 

ambulatory side CPOE feeds into eprescribing, and on the hospital side 

electronic medication administration 

record may be used, but neither of these 

are requirements for CPOE. For 

example, a medication could be entered 

into CEHRT using CPOE and then be 

electronically transmitted to a 

pharmacy. This would be both CPOE 

and e-prescribing. However, a 

medication could be entered into 

CEHRT using CPOE and then a printed 

copy of the prescription could be 

generated by CEHRT and given to the 

patient. This would still be CPOE, but 

not e-prescribing. Similarly, whether the 

ordering of laboratory or radiology 

services using CPOE in fact results in 

the order being transmitted 

electronically to the laboratory or 

radiology provider does not dictate 

whether CPOE was met. CPOE is a step 

in a process that takes place in both 

hospital and ambulatory settings, and 

we continue to believe it is relevant to 

both settings. 

After consideration of the public 

comments received, we are modifying 

this objective for EPs as § 495.6(j)(1)(i) 

and for eligible hospitals and CAHs at 

§ 495.6(l)(1)(i) to use the same language 

as Stage 1 (with the addition of 

laboratory and radiology orders), as we 

did not finalize our proposed changes to 

when the order must be entered: ‘‘Use 

computerized provider order entry 

(CPOE) for medication, laboratory, and 

radiology orders directly entered by any 

licensed healthcare professional who 

can enter orders into the medical record 

per state, local, and professional 

guidelines.’’ 

Proposed Measure: More than 60 

percent of medication, laboratory, and 

radiology orders created by the EP or 

authorized providers of the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period are 

recorded using CPOE. 

In Stage 1 of meaningful use, we 

adopted a measure of more than 30 

percent of all unique patients with at 

least one medication in their medication 

list seen by the EP or admitted to the 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period have at 

least one medication order entered 

using CPOE. In the Stage 1 final rule, we 

adopted a threshold of 60 percent for 

this measure for Stage 2. 

In our proposed rule, we discussed 

how our experience with Stage 1 has 

shown that the denominator of all 

orders created by the EP or in the 

hospital would not be unduly 

burdensome for providers and creates a 

better measurement for CPOE usage, 

particularly for EPs who infrequently 

order medications. We explained that 

the denominator recommended by the 

HITPC of ‘‘patients with at least one 

type of order’’ is a proxy measure for the 

number of orders issued. We asked for 

comments on whether the barriers to 

collecting information for our proposed 

denominator would be greater in a 

hospital or ambulatory setting. We also 

requested that commenters suggest 

different denominators or measures and 

encouraged any commenter proposing 

an alternative denominator to discuss 

whether the proposed threshold or an 

alternative threshold should be used for 

this measure and to include any 

exclusions they believe are necessary 

based on their alternative denominator. 

We also stated in our proposed rule 

that we believed providers do not roll 

out CPOE for only one order type, but 

rather for a package of order types. The 

HITPC had recommended a percentage 

threshold for laboratory orders, but a 

yes/no attestation of one order for 

radiology (not for both laboratory and 

radiology, as we mistakenly stated in 

the proposed rule). We also expressed 

concerns in the proposed rule about the 

possibility that an EP, eligible hospital 

or CAH could create a test environment 

to issue the one order and not roll out 

the capability widely or at all. For these 

reasons, we proposed a percentage 

threshold for all three types of orders: 

medication, laboratory, and radiology. 

Comment: Commenters both 

supported and opposed the new 

denominator for CPOE. Those 

supporting the proposed denominator 

did so for its simplicity and greater 

accuracy for measuring actual CPOE 

usage. Commenters that opposed the 

proposed denominator did so for one of 

two reasons. Either they were concerned 

with the burden associated with 

counting paper or other orders that are 

never entered into CEHRT or they were 

concerned that the proposed 

denominator requires much higher 

performance of CPOE usage. For 

example, in the hospital setting an 

inpatient might have 20 orders during a 

stay. Under the proposed denominator, 

13 of those orders would have to be 

entered using CPOE, while under the 

current denominator only one order 

would have to be entered using CPOE. 

A few commenters opposed the new 

denominator for both reasons. 

Response: In regards to the perceived 

higher performance of CPOE usage 

required by switching from the Stage 1 

denominator to the Stage 2 proposed 

denominator, the sole purpose of the 

proxy measure for CPOE used in Stage 

1 was to alleviate the measurement 

burden, not create a lower level of CPOE 

usage than implied by the percentage 

threshold. Therefore, as a more accurate 

measure is possible, it should reflect the 

percentage of CPOE use indicated by the 

established thresholds. In regards to the 

burden of the measure, we had stated in 

our proposed rule that the reason we 

believed we could move to the proposed 

denominator was feedback from many 

providers indicating that they could in 

fact measure the proposed denominator. 

In addition due to problems associated 

with the proxy for EPs who have 

comprehensive medication lists for their 

patients, but were not the ordering 

provider for many of those medications 

some EPs were having to use an 

alternative measure issued through 

guidance (https://questions.cms.gov/ 

faq.php?id=5005&faqId=3257) that 

allowed them to only include patients 

with medications the EP had ordered. 

We assume in determining the measures 

of meaningful use that the patient’s 

medical record conforms to existing 

Federal and state laws, which we 

believe would generally require that all 

orders issued by a provider for a patient 

become part of the patient’s medical 

record (for example, 42 CFR 

482.24(c)(2)(vi)). Therefore, the concept 

that some orders do not become part of 

mstockstill on DSK4VPTVN1PROD with RULES2

53988 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

the CEHRT means that the provider is 

maintaining patient medical records 

both electronically in CEHRT and 

outside of CEHRT using either paper 

charts or another electronic system. 

When a provider starts their first Stage 

2 EHR reporting period, they will have 

been using CEHRT for at least 15 

months. In our proposed rule, we have 

stated our belief that most providers 

would have fully transitioned patients’ 

medical records to CEHRT by the time 

they start Stage 2. However, as 

discussed previously, we are leaving 

open the option for limiting certain 

measures to only those records 

maintained in CEHRT. As this is one of 

those measures, there is no reason to 

change the measure to accommodate 

patient records not maintained in 

CEHRT as provider can choose to not 

include records not maintained in 

CEHRT in the denominator. Thus, we 

finalize the denominator as proposed. 

Comment: Commenters requested 

clarification on whether the measure 

puts all medication, laboratory and 

radiology orders in the same 

denominator and therefore it was 

potentially possible to meet the 60 

percent threshold without CPOE being 

used 60 percent of the time for one or 

more order type, up to and including 

the possibility that CPOE may never be 

used for one or more order type. Many 

commenters suggested that if all orders 

were in the same denominator this was 

not a good measure of the expansion of 

CPOE to laboratory and radiology and 

that the orders should be broken out 

separately. Only a few commenters 

suggested that the denominator should 

be the aggregate of all three types of 

orders. 

Response: We agree with the 

commenters that an aggregate 

denominator does not best reflect our 

expansion to laboratory and radiology 

and therefore create a separate 

denominator for each order type. This is 

consistent with the suggestions of the 

majority of commenters and most 

accurately reflects the use of CPOE. 

While CPOE does not require the 

electronic transmission of the order, 

many CEHRT will be linked to the 

technology systems that manage 

medication, as well as those for 

laboratories and radiology departments. 

These systems may be different thereby 

presenting unique challenges for each 

order type that could result in differing 

roll out times and utilization rates. In 

addition, a provider with a high number 

of one order type compared to others 

may even be able to reach a combined 

threshold without implementing CPOE 

for one or more of the order types. This 

would negate the benefits of expanding 

CPOE to these order types. We have 

exclusionary criteria for those providers 

who so infrequently issue an order type 

that it is not practical to implement 

CPOE for that order type. 

Comment: We received several 

suggestions on the percentage threshold 

for medication orders to reduce it below 

60 percent. The suggestions ranged from 

50 percent to 30 percent. Two reasons 

were given. First, that 60 percent was 

simply too high. Second, that the 

proposed denominator made 30 percent 

a much higher bar than it was when the 

proxy was in place and the threshold 

should not be raised until we have data 

based on the proposed denominator. 

Response: As we stated previously, 

the purpose of the proxy denominator 

was not to create a lower bar than CPOE 

usage at 30 percent, but to address 

measurement burden. While we agree 

that the information generated using the 

proxy denominator for CPOE is different 

from the finalized denominator, this is 

only true in a limited set of 

circumstances, especially for EPs. For it 

to be different at all, a provider must 

have ordered more than one medication 

for a patient during the EHR reporting 

period. Furthermore, this is most likely 

limited to providers who see a patient 

on more than one occasion. We believe 

it would be highly unlikely that a 

provider would use CPOE to order one 

medication and then not use it to order 

another during the same encounter or 

admission. For these reasons, we believe 

that while not a perfect correlation the 

information gained through Stage 1 

attestations. The Stage 1 attestations 

provide a reasonable basis on which to 

set the Stage 2 thresholds. We believe it 

is reasonable to expect the actual use of 

CPOE to increase from 30 percent in 

Stage 1 to 60 percent in Stage 2 and 

consist with the expectations that were 

finalized in the Stage 1 regulations. 

Therefore, for medication orders, we 

finalize the threshold at 60 percent. 

Comment: Some commenters 

maintain that the addition of laboratory 

and radiology orders to CPOE is a new 

function and should not be introduced 

at the same threshold. 

Response: Based on the same logic 

supporting the 60 percent threshold for 

medication orders (that is, 30 percent is 

reasonable when CPOE is first 

introduced for an order type, and 60 

percent in the next stage following 

CPOE introduction), we agree with the 

commenters that the thresholds should 

be different. We finalize a threshold of 

30 percent for each laboratory and 

radiology orders. 

After consideration of the public 

comments received, we are splitting the 

proposed measure into three measures 

and changing the threshold for 

radiology and laboratory orders at 

§ 495.6(j)(1)(ii) for EPs and 

§ 495.6(l)(1)(ii) for eligible hospitals and 

CAHs. 

• More than 60 percent of medication 

orders created by the EP or authorized 

providers of the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period are recorded using 

CPOE. 

• More than 30 percent of laboratory 

orders created by the EP or authorized 

providers of the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period are recorded using 

CPOE. 

• More than 30 percent of radiology 

orders created by the EP or authorized 

providers of the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period are recorded using 

CPOE. 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(a)(1). 

As discussed in the comment and 

response section, an EP, eligible 

hospital or CAH can limit the 

denominators to only include 

medication, laboratory and radiology 

orders for patients whose records are 

maintained using CEHRT. 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of 

medication orders created by the EP or 

authorized providers in the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period. 

• Numerator: The number of orders 

in the denominator recorded using 

CPOE. 

• Threshold: The resulting percentage 

must be more than 60 percent in order 

for an EP, eligible hospital or CAH to 

meet this measure. 

Exclusion: Any EP who writes fewer 

than 100 medication orders during the 

EHR reporting period. 

• Denominator: Number of radiology 

orders created by the EP or authorized 

providers in the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period. 

• Numerator: The number of orders 

in the denominator recorded using 

CPOE. 

• Threshold: The resulting percentage 

must be more than 30 percent in order 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53989 

for an EP, eligible hospital or CAH to 

meet this measure. 

Exclusion: Any EP who writes fewer 

than 100 radiology orders during the 

EHR reporting period. 

• Denominator: Number of laboratory 

orders created by the EP or authorized 

providers in the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period. 

• Numerator: The number of orders 

in the denominator recorded using 

CPOE. 

• Threshold: The resulting percentage 

must be more than 30 percent in order 

for an EP, eligible hospital or CAH to 

meet this measure. 

Exclusion: Any EP who writes fewer 

than 100 laboratory orders during the 

EHR reporting period. 

An EP through a combination of 

meeting the thresholds and/or 

exclusions must satisfy all three 

measures for this objective. 

A hospital must meet the thresholds 

for all three measures. 

Proposed EP Objective: Generate and 

transmit permissible prescriptions 

electronically (eRx). 

In the proposed rule, we noted that 

the use of electronic prescribing has 

several advantages over having the 

patient carry the prescription to the 

pharmacy or directly faxing a 

handwritten or typewritten prescription 

to the pharmacy. When the EP generates 

the prescription electronically, CEHRT 

can recognize the information and can 

provide decision support to promote 

safety and quality in the form of adverse 

interactions and other treatment 

possibilities. The CEHRT can also 

provide decision support that promotes 

the efficiency of the health care system 

by alerting the EP to generic alternatives 

or to alternatives favored by the 

patient’s insurance plan that are equally 

effective. Transmitting the prescription 

electronically promotes efficiency and 

safety through reduced communication 

errors. It also allows the pharmacy or a 

third party to automatically compare the 

medication order to others they have 

received for the patient. This 

comparison allows for many of the same 

decision support functions enabled at 

the generation of the prescription, but 

bases them on potentially greater 

information. 

We proposed to continue to define 

prescription as the authorization by an 

EP to dispense a drug that will not be 

dispensed without such authorization. 

This includes authorization for refills of 

previously authorized drugs. We 

proposed to define a permissible 

prescription as all drugs meeting the 

definition of prescription not listed as a 

controlled substance in Schedules II–V 

http://www.deadiversion.usdoj.gov/ 

schedules/index.html. Although the 

Drug Enforcement Administration’s 

(DEA) interim final rule on electronic 

prescriptions for controlled substances 

(75 FR 16236) removed the Federal 

prohibition to electronic prescribing of 

controlled substances, some challenges 

remain including more restrictive state 

law and widespread availability of 

products both for providers and 

pharmacies that include the 

functionalities required by the DEA’s 

regulations. We asked for public 

comments as to whether over the 

counter (OTC) medicines will be 

routinely electronically prescribed and 

proposed to continue to exclude them 

from the definition of a prescription. 

In our proposed rule we discussed 

several different workflow scenarios are 

possible when an EP prescribes a drug 

for a patient. First, the EP could 

prescribe the drug and provide it to the 

patient at the same time, and sometimes 

the EP might also provide a prescription 

for doses beyond those provided 

concurrently. Second, the EP could 

prescribe the drug, transmit it to a 

pharmacy within the same organization, 

and the patient would obtain the drug 

from that pharmacy. Third, the EP could 

prescribe the drug, transmit it to a 

pharmacy independent of the EP’s 

organization, and the patient would 

obtain the drug from that pharmacy. 

Although each of these scenarios would 

result in the generation of a 

prescription, the transmission of the 

prescription would vary. In the first 

situation, there is no transmission. In 

the second situation, the transmission 

may be the viewing of the generation of 

the prescription by another person using 

the same CEHRT as the EP, or it could 

be the transmission of the prescription 

from the Certified EHR Technology used 

by the EP to another system used by the 

same organization in the pharmacy. In 

the third situation, the EP’s Certified 

EHR Technology transmits the 

prescription outside of their 

organization either through a third party 

or directly to the external pharmacy. 

These differences in transmissions 

create differences in the need for 

standards. We proposed that only the 

third situation would require standards 

to ensure that the transmission meets 

the goals of electronic prescribing. In 

the first two scenarios one organization 

has control over the whole process. In 

the third scenario, the process is 

divided between organizations. In that 

situation, standards can ensure that 

despite the lack of control the whole 

process functions reliably. To have 

successfully e-prescribed, we proposed 

that the EP needs to use CEHRT as the 

sole means of creating the prescription, 

and when transmitting to an external 

pharmacy that is independent of the 

EP’s organization such transmission 

must use standards adopted for EHR 

technology certification. 

We did not receive any public 

comments on this objective, therefore, 

we are finalizing this objective at 

§ 495.6(j)(2)(i) as proposed. 

Proposed EP Measure: More than 65 

percent of all permissible prescriptions 

written by the EP are compared to at 

least one drug formulary and 

transmitted electronically using CEHRT. 

We proposed a new exclusion for 

Stage 2 that would allow EPs to exclude 

this objective if no pharmacies within 

25 miles of an EP’s practice location at 

the start of his/her EHR reporting period 

accept electronic prescriptions. This is 

25 miles in any straight line from the 

practice location independent of the 

travel route from the practice location to 

the pharmacy. We stated that EP’s 

practicing at multiple locations would 

be eligible for the exclusion if any of 

their practice locations that are 

equipped with CEHRT meet this 

criteria. An EP would not be eligible for 

this exclusion if he or she is part of an 

organization that owns or operates its 

own pharmacy within the 25-mile 

radius regardless of whether that 

pharmacy can accept electronic 

prescriptions from EPs outside of the 

organization. We also proposed an 

exclusion for EPs who write fewer than 

100 prescriptions during the EHR 

reporting period. 

Comment: Most commenters agreed 

with the exclusion of controlled 

substances in the denominator. They 

were concerned about industry 

readiness as well as potentially 

conflicting state regulations. Other 

commenters expressed concerns that 

specialists (that is, surgeons, 

psychiatrists) who write prescriptions 

that are not permissible (that is, 

controlled substances) would not be 

able to meet the measure. 

Response: We agree with the 

commenters and will continue to 

exclude controlled substances from the 

denominator. However, we are also 

adding an alternative denominator to 

provide additional flexibility for EPs 

who are able to electronically prescribe 

controlled substances and want to count 

these prescriptions in the measure. 

Comment: Most commenters did not 

support the inclusion of OTC medicines 

in this objective, as OTC medicines are 

not usually intended for the pharmacy 

to fill. Those commenters who did 

support it noted that OTC medicines are 

mstockstill on DSK4VPTVN1PROD with RULES2

53990 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

prescribed often times because it allows 

patients to use their health care 

spending accounts to pay for the cost. 

Response: After consideration of 

public comments, we agree with the 

majority of commenters in that OTC 

medicines should not be included as a 

part of this objective. While some OTC 

medicines are ordered by the EP, the 

low prevalence of such occurrences 

means the costs of including them in 

both measurement and actual eprescribing outweighs any benefit of 

inclusion. 

Comment: Most commenters thought 

the proposed threshold was too high or 

just right. Those who thought it was too 

high expressed concerns about the 

abilities of mail-order pharmacies to 

accept electronic subscriptions. Some 

commenters suggested lowering the 

threshold to 50 percent. Other 

commenters expressed concerns that 

patients may prefer a paper prescription 

and suggested excluding those patients 

from the denominator. The commenters 

who thought the proposed threshold 

was ‘‘just right’’ noted that most EPs 

who successfully demonstrated 

meaningful use for Stage 1 far exceeded 

the Stage 1 threshold of 40 percent. 

Response: Preliminary analysis of 

Stage 1 meaningful use attestation data 

shows that those EPs who successfully 

attested for this measure exceeded the 

40 percent threshold—many reporting 

thresholds of 80–100 percent. However, 

the Surescripts Q4 2011 Report suggests 

that close to 40 percent of physicians 

who began e-prescribing in 2008 meet 

the 65 percent threshold. This report 

only represents the earliest adopters. 

Based on public comments, we believe 

the 65 percent threshold we proposed 

may be unattainable for many EPs and 

question whether any real difference in 

provider behavior is achieved with a 65 

percent threshold versus a 50 percent 

threshold. This lower threshold also 

accounts for patients who may prefer a 

paper prescription, rather than having 

their prescription sent to a pharmacy 

electronically. After consideration of 

public comments, we are finalizing the 

threshold for this measure at 50 percent. 

Comment: Most commenters 

supported comparing prescriptions 

written by the EP to a drug formulary, 

but not without concern. Many noted 

that drug formularies are not always 

readily available, are linked to specific 

payers, or may not otherwise be readily 

available. 

Response: After review of the public 

comments, we realize this measure 

needs to be further clarified. We 

recognize that not every patient will 

have a formulary that is relevant for him 

or her. Therefore, we require not that 

the CEHRT check each prescription 

against a formulary relevant for a given 

patient, but rather that the CEHRT check 

each prescription for the existence of a 

relevant formulary. If a relevant 

formulary is available, then the 

information can be provided. We 

believe that this initial check is 

essentially an on or off function for the 

CEHRT and should not add to the 

measurement burden. Therefore, with 

this clarification of the check we are 

referring to, we are finalizing the drug 

formulary check as a component of this 

measure. We look forward to the day 

when a relevant formulary is available 

for every patient. We also modified the 

measure to use the word ‘‘query’’ 

instead of ‘‘compare’’ because it better 

explains the process in which the EP 

uses the CEHRT to consult the 

information provided in the formulary. 

Comment: Many commenters 

expressed concerns about patients who 

request paper copies of their 

prescriptions and how they would be 

accounted for in this measure. 

Commenters also expressed concerns 

about patients who prefer to use mailorder pharmacies that do not accept 

eRx. 

Response: We have accounted for 

patient preferences by lowering the 

threshold for this measure from 65 

percent to 50 percent. 

Comment: Many commenters 

expressed concerns that the word 

‘‘permissible’’ was omitted from the 

proposed exclusion for EPs who write 

fewer than 100 prescriptions during the 

EHR reporting period. 

Response: We agree with commenters 

in that we inadvertently omitted the 

word ‘‘permissible’’ from this exclusion. 

After consideration of public comments, 

we are finalizing this exclusion as ‘‘EPs 

who write fewer than 100 permissible 

prescriptions during the EHR reporting 

period.’’ 

Comment: Many commenters 

supported this exclusion but expressed 

concerns about how it was proposed 

and would be implemented. Some 

commenters suggested reducing the 

radius to 10 miles or less in urban areas 

and leaving it at 25 miles in rural areas. 

Other commenters suggested revising 

this exclusion for EPs where less than 

20 percent of pharmacies e-prescribe 

within a 25-mile radius of their office. 

Other commenters expressed concerns 

that there may only be a limited number 

of pharmacies in their geographic area 

that can accept prescriptions 

electronically. Yet others suggested 

including a grace period for EPs in areas 

where no pharmacies e-prescribe at the 

beginning of their EHR reporting period, 

but later begin accepting eRx. 

Response: We appreciate the 

commenters’ concerns about this 

exclusion. We agree with commenters in 

that a 25-mile radius may be too large. 

We believe the 10-mile radius is more 

reasonable as it takes the country’s 

geographic diversity (urban, suburban, 

rural areas) into account. We are 

therefore finalizing that if no 

pharmacies within a 10-mile radius of 

an EP’s practice location at the start of 

the EHR reporting period accept 

electronic prescriptions, the EP would 

qualify for this exclusion, unless the EP 

is part of an organization that owns or 

operates a pharmacy within the 10-mile 

radius. As for patient preference, we 

agree with commenters that not all 

patients will want to go to a particular 

pharmacy just because they accept 

electronic prescriptions. However, we 

believe we accounted for patient 

preference by lowering the threshold for 

the measure to 50 percent. 

After consideration of public 

comments, we are revising the measure 

at § 495.6(j)(2)(ii) to read: ‘‘More than 50 

percent of all permissible prescriptions, 

or all prescriptions, written by the EP 

are queried for a drug formulary and 

transmitted electronically using 

CEHRT.’’ 

We further specify that in order to 

meet this objective and measure, an EP 

must use the capabilities and standards 

of CEHRT at 45 CFR 170.314(b)(3) and 

45 CFR 170.314(a)(10). 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of 

prescriptions written for drugs requiring 

a prescription in order to be dispensed 

other than controlled substances during 

the EHR reporting period; or 

Number of prescriptions written for 

drugs requiring a prescription in order 

to be dispensed during the EHR 

reporting period. 

• Numerator: The number of 

prescriptions in the denominator 

generated, queried for a drug formulary 

and transmitted electronically using 

CEHRT. 

• Threshold: The resulting percentage 

must be more than 50 percent in order 

for an EP to meet this measure. 

Exclusions: Any EP who: (1) Writes 

fewer than 100 permissible 

prescriptions during the EHR reporting 

period; or (2) does not have a pharmacy 

within their organization and there are 

no pharmacies that accept electronic 

prescriptions within 10 miles of the EP’s 

practice location at the start of his/her 

EHR reporting period. 

Consolidated Objective: Maintain an 

up-to-date problem list of current and 

active diagnoses. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53991 

Consolidated Objective: Maintain 

active medication list. 

Consolidated Objective: Maintain 

active medication allergy list. 

For Stage 2, we proposed to 

consolidate the objectives for 

maintaining an up-to-date problem list, 

active medication list, and active 

medication allergy list with the Stage 2 

objective for providing a summary of 

care for each transition of care or 

referral. We stated that we continue to 

believe that an up-to-date problem list, 

active medication list, and active 

medication allergy list are important 

elements to be maintained in CEHRT. 

However, the continued demonstration 

of their meaningful use in Stage 2 would 

be required by other objectives focused 

on the transitioning of care of patients 

removing the necessity of measuring 

them separately. Providing this 

information is critical to continuity of 

care, so we proposed to add these as 

required fields in the summary of care 

for the following Stage 2 objective: ‘‘The 

EP, eligible hospital or CAH who 

transitions their patient to another 

setting of care or provider of care or 

refers their patient to another provider 

of care should provide a summary care 

record for each transition of care or 

referral.’’ We stated that EPs and 

hospitals would have to ensure the 

accuracy of these fields when providing 

the summary of care, which we believe 

would ensure a high level of compliance 

in maintaining an up-to-date problem 

list, active medication list, and active 

medication allergy list for patients. The 

required standards for these fields are 

discussed in the ONC standards and 

certification final rule published 

elsewhere in this issue of the Federal 

Register. 

Comment: Overall, we received very 

few comments on our proposal to 

consolidate the up-to-date problem list, 

active medication list, and active 

medication allergy list objectives. Some 

commenters opposed our proposal as 

they believe it would detract from the 

importance of these items. However, the 

vast majority of those who commented 

on this proposal supported the 

consolidation of these objectives. 

Response: After consideration of 

public comments, we are finalizing the 

consolidation of these objectives as 

proposed for the reasons discussed in 

the proposed rule. The objectives of 

maintaining an up-to-date problem list, 

active medication list, and active 

medication allergy list will be 

consolidated with the Stage 2 objective 

for providing a summary of care for each 

transition of care or referral. 

Proposed EP Objective: Record the 

following demographics: preferred 

language, gender, race and ethnicity, 

and date of birth. 

Proposed Eligible Hospital/CAH 

Objective. Record the following 

demographics: preferred language, 

gender, race and ethnicity, date of birth, 

and date and preliminary cause of death 

in the event of mortality in the eligible 

hospital or CAH. 

We proposed to continue the policy 

that EPs, eligible hospitals and CAHs 

collect baseline demographic data for all 

unique patients in the EHR using OMB 

standards for race and ethnicity. The 

proposed rule outlines some of the 

numerous benefits from recording basic 

patient demographic information in the 

EHR, including improved patientcentered care and management of the 

health of populations. In response to 

multiple comments from the Stage 1 

final rule regarding the preliminary 

cause of death data element required for 

eligible hospitals and CAHs, we 

clarified the following; this element is 

the preliminary cause of death recorded 

by the hospital and is not required to be 

amended when additional information 

becomes available, there is no specified 

timeframe for recording this element, 

and we invited additional public 

comment regarding these clarifications 

in the proposed rule. We also asked for 

public comment on the burden and 

ability to include additional measures of 

disability status, gender identity and/or 

sexual orientation. 

Comment: We received many 

comments suggesting CMS differentiate 

between the terms sex and gender. One 

commenter provided the definition that 

the term sex is used in recording vital 

health statistics that describe the 

physiological characteristics at time of 

birth. The term gender incorporates 

behaviors, roles, and expectations 

corresponding to an individual’s sex 

and is generally self reported. 

Response: We appreciate this 

clarification and will incorporate the 

change in terminology for the final rule 

using the term sex instead of gender in 

EP, eligible hospital and CAH objectives 

for recording demographics. This 

change in terminology aligns with vital 

statistic reporting and the HHS final 

demographic data collection standards 

published October 31, 2011. 

Comment: Several commenters 

indicated that the collection of race and 

ethnicity demographic information can 

be sensitive and patients may be 

unwilling or uncomfortable reporting 

this information to the individual 

collecting demographic data. Other 

comments supported CMS clarification 

in the Stage 1 final rule that providers 

can be allowed to account for patients 

who decline to provide elements of 

demographic information. Additional 

comments suggested that a single 

system parameter be developed to 

identify states that prohibit data 

reporting should be available to the 

EHR. 

Response: If a patient declines to 

provide information of ethnicity or race 

or if capturing a patient’s ethnicity or 

race is prohibited by state law, this 

should be duly noted as structured data 

in the EHR and this would still count as 

an entry for the purpose of meeting this 

measure. A study by the Agency for 

Healthcare Research and Quality 

(AHRQ) states that current state 

prohibitions on the collection of 

ethnicity and race apply to health plans’ 

collection of data at the time of 

enrollment. Title VI of the Civil Rights 

Act of 1964 permits health care 

organizations to collect race, ethnicity, 

and preferred language patient data for 

the purpose of quality improvement. 

Comment: Several commenters 

suggested that CMS use the same 

definition for race and ethnicity as the 

Centers for Disease Control and 

Prevention (CDC) and the United States 

Census Bureau. Other commenters were 

concerned about the need to collect data 

granular enough to identify differences 

between subpopulations and aligned 

across government programs. 

Response: We recognize that the CDC 

has developed codes that allow for the 

mapping of more detailed race and 

ethnicity categories such as those 

maintained by the U.S. Bureau of the 

Census to the less detailed OMB 

standard. We appreciate that providers 

may need to collect more granular 

demographic data to manage their 

patient populations. For purposes of 

achieving Stage 2 of meaningful use, we 

will continue to rely on the OMB 

standard as a minimum standard for the 

collection of race and ethnicity data. 

EPs, eligible hospitals, and CAHs who 

wish to collect more granular level data 

on patient race and ethnicity may do so 

as long as they can map the data to 1 

of the 5 races included in the existing 

OMB standards. The standards 

associated with the meaningful use 

objectives and measures are discussed 

further in the ONC standards and 

certification criteria final rule and we 

refer readers to that regulation 

published elsewhere in this issue of the 

Federal Register. 

Comment: Many commenters agreed 

with the need to incorporate disability 

status in EHR technology. However, it 

was also clear that several of these 

commenters varied in their definition of 

disability with interpretations that 

ranged from physical, mental, 

occupational, and economic disability 

mstockstill on DSK4VPTVN1PROD with RULES2

53992 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

1 Implementation Guide for CDA Release 2.0 (US 

REALM) July 2012, © 2012 Health Level Seven, Inc. 

Ann Arbor, MI. 

status. Commenters also differed 

regarding the most appropriate location 

for the capture and storage of disability 

status data elements within the EHR. 

Suggestions for where to incorporate 

disability status data varied (for 

example; from the demographic 

objective, to physician notes, and/or the 

problem list component of the summary 

of care document). Another commenter 

suggested that the demographic 

objective should be limited to collecting 

data with static values and the active 

problem list, electronic notes and/or 

care summary documents that are 

continually updated would be more 

appropriate for recording changes in 

patient disability status. 

Response: We wish to clarify that the 

term disability status used in the 

proposed rule was meant to be allencompassing by incorporating both the 

concepts of physical and cognitive 

disabilities as well as the concept of 

functional status limitations that impact 

an individual’s capability to perform 

activities in different environments. 

This latter concept incorporates metrics 

useful for planning and coordination 

across care settings. Commenters varied 

in their responses regarding the level of 

consensus on measurement standards 

for each of these health status measures. 

Since publishing the proposed rule we 

have learned that significant progress 

has been made regarding the capture of 

functional status into the consolidated 

clinical document architecture (C–CDA) 

standard for summary of care records. 

The C–CDA Implementation Guide 

provides the following examples that 

may be incorporated under functional 

status; assessments of a patient’s 

language, vision, hearing, activities of 

daily living, behavior, general function, 

mobility, self-care status, physical state 

and cognitive function.1 The C–CDA 

standards support the exchange of 

clinical documents between those 

involved in the care of a patient and 

allow for the re-use of clinical data for 

clinical care giving, public health 

reporting, quality monitoring, patient 

safety and clinical trials. This inclusion 

is addressed more fully under the 

discussion of the transition of care 

objective in this final rule. 

We strongly support the adoption, 

implementation and meaningful use of 

CEHRT for all individuals and the 

reduction of barriers for persons with 

disabilities. In finalizing this rule, we 

also considered the operational 

challenges that could result from the 

lack of consensus noted by many 

commenters to incorporate a physical 

disability standard measure in the 

demographic section of CEHRT at this 

time. As a result, we will not require the 

collection of disability status data under 

the demographic objective for Stage 2 of 

meaningful use. However, we suggest 

that providers examine the questions 

developed by the HHS as required by 

section 4302 of the Affordable Care Act. 

The questions resulted from an 

interagency process and are closely 

aligned to the Census Bureau’s 

American Community Survey and the 

International Classification of Disability. 

These questions may be found on the 

HHS Web site at http:// 

minorityhealth.hhs.gov/templates/ 

content.aspx?ID=9232#1. The answers 

to these questions could be incorporated 

as functional status or other data 

elements in the C–CDA summary of care 

document mentioned above and 

discussed more fully in the transition of 

care objective later in this rule. 

We will continue to work with ONC, 

other federal agencies and seek the 

advice of the HIT Policy Committee to 

explore further how disability status 

could be included in meaningful use 

Stage 3. 

Comments: Many commenters 

supported the proposed inclusion of 

recording gender identity and/or sexual 

orientation as part of the demographic 

objective. Other commenters suggested 

that the collection of this information is 

extremely sensitive and could be 

considered offensive for some patients 

especially when collected by 

administrative staff. Still other 

commenters did not see the clinical 

significance of collecting and recording 

this information in the demographic 

section of the EHR. Others commenters 

were against recording gender identity 

and/or sexual orientation because they 

did not consider this would provide 

additional clinical benefit. Still others 

suggested that the reporting of gender 

identity or sexual orientation be 

optional and up to individual clinician 

judgment whether or not it is 

appropriate to collect this information. 

Similar to the comments for the 

proposed inclusion of disability status, 

commenters noted both the data 

collection challenges and data reporting 

burden. Many commenters were 

opposed to the mandatory collection of 

all three additional measures for Stage 

2 of meaningful use and suggested that 

reporting could be optional. 

Response: Considering the lack of 

consensus for the definition of the 

concept of gender identity and/or sexual 

orientation as well as for a standard 

measure of the concept and where it 

would be most appropriate to store the 

data within the EHR, we will await 

further development of a consensus for 

the goal and standard of measurement 

for gender identity and/or sexual 

orientation. Additionally, we note that 

many commenters raised concerns as to 

whether such data collection is 

necessary for all EPs, eligible hospital, 

and CAH regardless of specialty. 

Comments: Several additional 

measures were suggested under the 

demographic objective including; 

measuring the level of access to and use 

of the internet, measuring computer 

literacy, and measuring standardized 

occupation using established industry 

codes. 

Response: We appreciate the 

numerous comments suggesting 

additional demographic information 

that will allow providers to improve the 

quality of individual patient centered 

care as well as population health. We 

may consider these suggestions further 

in the development of Stage 3 of 

meaningful use. 

Comment: A minority of commenters 

recommended removing the preliminary 

cause of death element altogether from 

the eligible hospital/CAH objective. 

Others suggested that the eligible 

hospital/CAH measure for preliminary 

cause of death be modified to simply 

capture whether or not the patient had 

a cause of death recorded, regardless of 

when that information was entered into 

the EHR, because the preliminary cause 

of death may often be inaccurate since 

by law the coroner or medical examiner 

makes the final determination for the 

patient’s death certificate. 

Response: We appreciate the 

suggestion for measure simplification. 

However, for this measure we want to 

respect the existing hospital workflow 

where a clinician evaluates the patient 

to pronounce the death. This 

preliminary cause of death is 

documented by the clinician in the 

patient’s chart. We recognize that these 

workflows may change as EHR 

technology develops and becomes more 

widely adopted and the exchange of 

health information is able to link to vital 

statistic reporting. However, for the time 

being the measure of preliminary cause 

of death under the demographic 

objective will remain unchanged. 

After consideration of the public 

comments received, we are modifying 

the meaningful use objective at 

§ 495.6(j)(3)(i) of our regulations as 

follows: EPs ‘‘Record all of the following 

demographics: Preferred language, sex, 

race, ethnicity, and date of birth.’’ 

After consideration of the public 

comments received, we are modifying 

the meaningful use objective at 

§ 495.6(l)(2)(i) of our regulations as 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53993 

follows: Eligible hospitals and CAHs 

‘‘Record all of the following 

demographics: Preferred language, sex, 

race, ethnicity, date of birth, date and 

preliminary cause of death in the event 

of mortality in the eligible hospital or 

CAH.’’ 

Proposed Measure: More than 80 

percent of all unique patients seen by 

the EP or admitted to the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period have 

demographics recorded as structured 

data. 

Comment: Most commenters were 

supportive of the increased threshold 

for this measure. 

Response: Our analysis of the 

meaningful use data for Stage 1 found 

that over 90 percent of EPs, eligible 

hospitals and CAHs were able to 

successfully report the demographic 

measure. Therefore, based on comments 

and actual performance data we do not 

foresee a burden in increasing the 

measure threshold from more than 50 

percent in Stage 1 to greater than 80 

percent in Stage 2. 

After consideration of public 

comments, we are finalizing this 

measure for EPs at § 495.6(j)(3)(ii) and 

for eligible hospitals and CAHs at 

§ 495.6(l)(2)(ii) as proposed. 

We further specify that in order to 

meet this objective and measure an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(a)(3). 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of unique 

patients seen by the EP or admitted to 

an eligible hospital or CAH inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period. 

• Numerator: The number of patients 

in the denominator who have all the 

elements of demographics (or a specific 

notation if the patient declined to 

provide one or more elements or if 

recording an element is contrary to state 

law) recorded as structured data. 

• Threshold: The resulting percentage 

must be more than 80 percent in order 

for an EP, eligible hospital or CAH to 

meet this measure. 

If a patient declines to provide one or 

more demographic elements this can be 

noted in the CEHRT and the EP or 

hospital may still count the patient in 

the numerator for this measure. The 

required elements and standards for 

recording demographics and noting 

omissions because of state law 

restrictions or patients declining to 

provide information will be discussed 

in the ONC standards and certification 

rule, published elsewhere in this issue 

of the Federal Register. 

Proposed Objective: Record and chart 

changes in the following vital signs: 

height/length and weight (no age limit); 

blood pressure (ages 3 and over); 

calculate and display body mass index 

(BMI); and plot and display growth 

charts for patients 0–20 years, including 

BMI. 

We proposed to continue our policy 

objective from Stage 1 to collect and 

record basic vital sign data for patients 

across health care settings. In the 

proposed rule, we outlined the benefits 

of documenting basic vital signs 

including that the data provides 

important clinical information on both 

the patient’s current condition as well 

as the ability to track changes in patient 

status over time. For Stage 2, we 

proposed to remove the age restrictions 

on recording height/length and weight, 

and also proposed to remove the age 

restrictions on calculating and 

displaying BMI and growth charts. In 

addition, we proposed to modify the 

Stage 1 blood pressure guideline to align 

with the American Academy of 

Pediatrics guideline recommendations 

to measure blood pressure for children 

3 years of age and older. We also 

proposed to continue our exclusions 

policy from Stage 1 (with modifications, 

as discussed below) for EPs who believe 

that recording and charting vital signs is 

outside the scope of their practice. 

Comment: Several commenters 

questioned why all providers need to 

collect vital sign data when this 

information should be available from a 

robust health information exchange 

across providers. 

Response: We will continue the Stage 

1 meaningful use policy that any 

method of obtaining height, weight and 

blood pressure is acceptable for the 

purpose of this objective as long as the 

information is recorded as structured 

data in the CEHRT. As stated in the 

proposed rule, the vital sign information 

can be entered into the patient’s medical 

record in a number of ways including: 

direct entry by the EP, eligible hospital, 

or CAH; entry by a designated 

individual from the EP, eligible 

hospital, or CAH’s staff; data transfer 

from another provider electronically, 

through an HIE or through other 

methods; or data entered directly by the 

patient through a portal or other means. 

Some of these methods are more 

accurate than others, and it is up to the 

EP or eligible hospital to determine the 

level of accuracy needed to care for their 

patient and how best to obtain this 

information. We also look forward to the 

time when a more robust health 

information exchange network will 

allow providers to share relevant data 

across settings and/or alert providers 

when additional data should be 

obtained. 

Comment: We received comments 

requesting that CMS include a statement 

clarifying which specialties would be 

included or excluded from this 

objective. 

Response: We appreciate commenter’s 

efforts to clarify this objective. However, 

we will continue our more general 

policy from Stage 1 (with modifications, 

as explained later) of allowing EPs to 

exclude this objective if they believe 

recording and charting changes in vital 

signs is not relevant to their scope of 

practice. We cannot define the scope of 

practice and/or interventions necessary 

for each individual patient and will 

continue to rely on provider 

determinations based on individual 

patient circumstances. Consider a 

hypothetical example of an elderly 

patient with multiple chronic 

conditions that includes depression. 

When the patient is seen by his 

behavioral healthcare provider to 

manage his depression, it is up to that 

provider to determine whether it would 

be medically necessary to record and 

chart the patient’s weight in order to 

manage the patient’s care. 

After consideration of public 

comments, we are finalizing this 

objective for EPs at § 495.6(j)(4)(i) and 

for eligible hospitals and CAHs at 

§ 495.6(l)(3)(i) as proposed. 

Proposed Measure: More than 80 

percent of all unique patients seen by 

the EP or admitted to the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period have 

blood pressure (for patients age 3 and 

over only) and height/length and weight 

(for all ages) recorded as structured data. 

We proposed to split the exclusions 

from Stage 1 such that an EP could 

choose to record height/length and 

weight only and exclude blood pressure, 

or record blood pressure only and 

exclude height/length and weight. We 

encouraged comments on this split and 

whether it should go both ways. We 

proposed to increase the threshold from 

more than 50 percent to more than 80 

percent for this measure. 

Comment: Several commenters agreed 

with the policy that height/length, 

weight, and blood pressure do not each 

need to be updated by a provider 

neither at every patient encounter nor 

even once per patient seen during the 

EHR reporting period. 

Response: We will maintain our 

policy from Stage 1 that it is up to the 

EP or hospital to determine whether 

height/length, weight, and blood 

mstockstill on DSK4VPTVN1PROD with RULES2

53994 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

pressure each need to be updated, the 

level of accuracy needed to care for their 

patient, and how best to obtain the vital 

sign information that will allow for the 

right care for each patient. 

Comment: Another commenter 

suggested that CMS clarify that the 

growth charts and BMI are not part of 

the actual measure for this objective. 

Response: We clarify that to satisfy 

the measure of this objective, the 

CEHRT must have the capability to 

calculate BMI and produce growth 

charts for patients as appropriate. Since 

BMI and growth charts are only 

produced when height/length and 

weight vital sign data are captured in 

the CEHRT, the measure is limited to 

these data elements. 

Overall commenters supported the 

added flexibility of our proposal to split 

the exclusion and allow EPs to record 

blood pressure only or height/length 

and weight only. Our analysis of the 

meaningful use data for Stage 1 found 

that over 90 percent of EPs, eligible 

hospitals and CAHs were able to 

successfully report the vital signs 

measure. We did not propose additional 

measure elements that could increase 

the reporting burden at this time. 

After consideration of the public 

comments received, we are finalizing 

this measure as proposed for EPs at 

§ 495.6(j)(4)(ii) and for eligible hospitals 

and CAHs at § 495.6(l)(3)(ii). 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(a)(4). The ability to 

calculate the measure is included in 

CEHRT. 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following: 

• Denominator: Number of unique 

patients seen by the EP or admitted to 

an eligible hospital’s or CAH’s inpatient 

or emergency department (POS 21 or 23) 

during the EHR reporting period. 

• Numerator: Number of patients in 

the denominator who have at least one 

entry of their height/length and weight 

(all ages) and/or blood pressure (ages 3 

and over) recorded as structured data. 

• Threshold: The resulting percentage 

must be more than 80 percent in order 

for an EP, eligible hospital, or CAH to 

meet this measure. 

• Exclusions: Any EP who sees no 

patients 3 years or older is excluded 

from recording blood pressure. Any EP 

who believes that all 3 vital signs of 

height/length, weight, and blood 

pressure have no relevance to their 

scope of practice is excluded from 

recording them. Any EP who believes 

that height/length and weight are 

relevant to their scope of practice, but 

blood pressure is not, is excluded from 

recording blood pressure. Any EP who 

believes that blood pressure is relevant 

to their scope of practice, but height/ 

length and weight are not, is excluded 

from recording height/length and 

weight. 

Proposed Objective: Record smoking 

status for patients 13 years old or older. 

We stated in the proposed rule that 

accurate information on smoking status 

provides context to a high number and 

wide variety of clinical decisions, such 

as immediate needs for smoking 

cessation or long-term outcomes for 

chronic obstructive pulmonary disease. 

Cigarette smoking is a key component to 

the current Million Hearts Initiative 

(http://millionhearts.hhs.gov). We did 

not propose rules on who may record 

smoking status or how often the record 

should be updated. In addition, we 

proposed to continue the age limitation 

at 13 years old. We also requested 

comments specifically on the possible 

inclusion of other forms of tobacco use 

and second hand smoke. 

Comment: We have received 

comments that assert that the objective 

is not relevant to a significant number 

of EPs due to their scope of practice and 

that it is redundant to the clinical 

quality measure ‘‘National Quality 

Forum (NQF) 28: Preventive Care and 

Screening: Tobacco Use: Screening and 

Cessation Intervention’’. Some of the 

comments suggest that it should be 

eliminated and those EPs for whom it is 

relevant select the CQM. 

Response: We disagree that the 

proposed objective and the clinical 

quality measure identified by 

commenters serve the same purpose and 

therefore only one should be included. 

The objective seeks to ensure that 

information on smoking status is 

included in the patient’s record. 

Furthermore, that the information is 

stored in a structured format so that it 

can automatically be identified by 

CEHRT as smoking status for possible 

reporting or exchanging. We also note 

that the clinical quality measure only 

focuses on patients 18 years or older, 

while the objective focuses on patients 

13 years or older. In addition, many 

quality measures related to smoking are 

coupled with follow-up actions by the 

provider such as counseling. We 

consider those follow-up actions to be 

beyond the scope of what we hope to 

achieve for this objective and would 

move the objective beyond the scope of 

practice for many providers. We 

disagree that the objective is not 

relevant to EPs seeing patient 13 years 

old or older. We note that this is 

intended to inform the provider. The 

frequency of when the information is 

updated, detail beyond the standard 

included in certification of EHR 

technology and many other factors 

discussed later are all left up to the 

provider to decide and fit to their scope 

of practice and their patient population. 

Comment: We received conflicting 

suggestions in comments regarding the 

age limitation. These comments can be 

divided into those suggesting a lower 

age (as low as 8 to 12), those supporting 

13 years old and those who believe it 

should be raised to 18 to match the 

clinical quality measures associated 

with smoking. 

Response: It is apparent from the 

comments that the appropriate age for 

smoking status is an elusive target 

highly dependent on the situation. For 

example, it was suggested in comments 

that the age be lowered for patients 

meeting certain characteristics such as 

parents who smoke or other risk factors, 

while remaining at 13 for other patients. 

In our review of the public comments, 

we do not believe a consensus has been 

reached on a different age limitation 

than our Stage 1 age limitation of 13 

years old and therefore finalize the age 

limitation as proposed. As with other 

meaningful use objectives and 

measures, this represents a minimum 

requirement. We encourage each and 

every provider to evaluate whether their 

scope of practice and/or patient 

population calls for collecting smoking 

status on patients younger than 13 or 

more detailed information than required 

by this objective. 

Comment: There continues to be 

strong support for expanding smoking to 

other forms of tobacco use. Commenters 

note that other types of tobacco use are 

supported by the clinical quality 

measure ‘‘NQF 28: Preventive Care and 

Screening: Tobacco Use: Screening and 

Cessation Intervention’’. 

Response: We refer readers to ONC’s 

standards and certification criteria final 

rule that is published elsewhere in this 

issue of the Federal Register for 

discussions on the adoption of a 

standard that would support other types 

of tobacco use. As ONC did not adopt 

a standard supporting other forms of 

tobacco use, we do not expand the 

objective. 

Comment: Some commenters 

expressed strong support for the 

inclusion of second-hand smoke either 

as part of this objective or as a separate 

objective. 

Response: We agree with the 

importance of collecting second-hand 

smoke information for many EPs and 

hospitals. However, as with other forms 

of tobacco use, there is not a standard 

on which to base the requirement of 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53995 

2Study Protocol for the Effects of computerized 

clinical decision support systems on practitioner 

performance and patient outcome: Methods of a 

decision-maker-researcher partnership systematic 

review. R Brian Haynes*, Nancy L Wilczynski and 

the Computerized Clinical Decision Support System 

(CCDSS) Systematic Review Team. 

IMPLEMENTATION SCIENCE 2010, 5:12. 

collection of this information as 

structured data. 

After consideration of the public 

comments received, we are finalizing 

this objective as proposed for EPs as 

§ 495.6(j)(5)(i) and for eligible hospitals 

and CAHs at § 495.6(l)(4)(i). 

Proposed Measure: More than 80 

percent of all unique patients 13 years 

old or older seen by the EP or admitted 

to the eligible hospital’s or CAH’s 

inpatient or emergency departments 

(POS 21 or 23) during the EHR reporting 

period have smoking status recorded as 

structured data. 

In our proposed rule, based on Stage 

1 data showing performance on this 

measure far exceeded the measure 

threshold of more than 50 percent, we 

proposed a threshold of more than 80 

percent for this measure for Stage 2 of 

meaningful use. 

Comment: We received comments 

asking for clarification on what must be 

recorded in the EHR and how often for 

the numerator to be met. 

Response: Information on smoking 

status must be present as structured data 

using the standard specified at 45 CFR 

170.314(a)(11). There is no requirement 

that the smoking status be entered into 

the record by a specific person or 

category of persons, there is no 

requirement that smoking status be 

entered into the CEHRT already in the 

terminology of the standard and there is 

no requirement on how frequently this 

information be updated. A patient 

indicating how many packs he smokes 

a day on a new patient questionnaire 

which is then entered by an 

administrative person and mapped in 

the CEHRT to one of the responses in 

the standard is valid for this measure. A 

physician could also ask a patient 

detailed questions to determine if the 

patient is a current smoker, input the 

information into the CEHRT, and select 

one of the responses of the standard. 

ONC has provided a mapping of 

SNOMED CT® ID to the descriptions at 

45 CFR 170.314(a)(11). 

Comment: We received a few 

comments on the threshold. Most were 

supportive, while others believe it 

should remain at 50 percent. 

Response: Due to our analysis of 

performance on this measure from Stage 

1 and the support received from 

commenters, we are finalizing the 

threshold as proposed. 

After consideration of public 

comments, we are finalizing this 

measure as proposed for EPs at 

§ 495.6(j)(5)(ii) and for eligible hospitals 

and CAHs at § 495.6(l)(4)(ii). 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(a)(11). 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of unique 

patients age 13 or older seen by the EP 

or admitted to an eligible hospital’s or 

CAH’s inpatient or emergency 

departments (POS 21 or 23) during the 

EHR reporting period. 

• Numerator: The number of patients 

in the denominator with smoking status 

recorded as structured data. 

• Threshold: The resulting percentage 

must be more than 80 percent in order 

for an EP, eligible hospital, or CAH to 

meet this measure. 

• Exclusion: Any EP, eligible 

hospital, or CAH that neither sees nor 

admits any patients 13 years old or 

older. 

CQM Reporting as a Stage 2 

Objective—We proposed to add CQM 

reporting to the definition of 

‘‘meaningful EHR user’’ under § 495.4 

instead of including it as a separate 

objective under § 495.6. Accordingly, 

we did not propose a CQM reporting 

objective for EPs and hospitals as part 

of the Stage 2 criteria under § 495.6. 

Comment: While some commenters 

indicated that this change would be 

confusing, most commenters supported 

this change. 

Response: We appreciate the support 

of commenters and believe including 

CQM reporting in the definition of 

‘‘meaningful EHR user’’ under § 495.4 

will actually alleviate confusion. 

Therefore, we are not finalizing an 

objective related to the reporting of 

CQMs in the Stage 2 criteria for 

meaningful use under § 495.6. Although 

CQM reporting is not listed as a separate 

objective and measure under § 495.6, it 

remains a condition for demonstrating 

meaningful use. 

Consolidated Objective: Implement 

drug-drug and drug-allergy interaction 

checks. 

For Stage 2, we proposed to make the 

objective for ‘‘Implement drug-drug and 

drug-allergy checks’’ one of the 

measures of the core objective for ‘‘Use 

clinical decision support to improve 

performance on high-priority health 

conditions.’’ We noted our belief that 

automated drug-drug and drug-allergy 

checks provide important information to 

advise the provider’s decisions in 

prescribing drugs to a patient. Because 

this functionality provides important 

clinical decision support that focuses on 

patient health and safety, we proposed 

to include this functionality as part of 

the objective for using clinical decision 

support. 

We discuss comments regarding this 

consolidation in the discussion of the 

clinical decision support objective. 

Proposed Objective: Use clinical 

decision support to improve 

performance on high-priority health 

conditions. 

We proposed to modify the clinical 

decision support (CDS) objective for 

Stage 2 such that CDS would be used to 

improve performance on high-priority 

health conditions. We stated it would be 

left to the provider’s clinical discretion 

to select the most appropriate CDS 

interventions for their patient 

population. We also proposed that the 

CDS interventions selected must be 

related to five or more of the clinical 

quality measures (CQMs) on which 

providers would be expected to report. 

The goal of the proposed CDS objective 

is for providers to implement 

improvements in clinical performance 

for high-priority health conditions that 

will result in improved patient 

outcomes. 

Comment: A few commenters voiced 

concern regarding the maturity of the 

development of clinical decision 

support systems. Others voiced a 

misconception that not all CEHRT 

includes pre-built CDS interventions 

where both capabilities and content are 

vendor supplied. The commenter went 

on to clarify that the CDS interventions 

must be specific to each provider’s 

requirements. Still others commented 

on the CMS change in terminology from 

CDS ‘‘rules’’ to CDS ‘‘interventions’’ 

increases the range of available 

interventions. 

Response: We recognize commenters’ 

concerns regarding the maturity of CDS 

systems. Closely linked to the 

development of EHRs, there are 

multiple factors impacting the evolution 

of CDS systems including; the 

increasing availability and 

sophistication of information 

technology in clinical settings, the 

increasing pace of publication of new 

evidence-based guidelines for clinical 

practice and the continual evaluation 

and improvements of CDS.2 We clarify 

that all CEHRT includes CDS 

interventions. The companion ONC 

standards and certification criteria final 

rule published elsewhere in this issue of 

the Federal Register includes further 

information regarding the criteria 

necessary to implement CDS in CEHRT 

mstockstill on DSK4VPTVN1PROD with RULES2

53996 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

for Stage 2 of meaningful use. With each 

incremental phase of meaningful use, 

CDS systems progress in their level of 

sophistication and ability to support 

patient care. For Stage 2 of meaningful 

use, it is our expectation that at a 

minimum, providers will select clinical 

decision support interventions to drive 

improvements in the delivery of care for 

the high-priority health conditions 

relevant to their patient population. 

Continuous quality improvement 

requires an iterative process in the 

implementation and evaluation of 

selected CDS interventions that will 

allow for ongoing learning and 

development. In this final rule, we will 

consider a broad range of CDS 

interventions that improve both clinical 

performance and the efficient use of 

healthcare resources in measuring 

providers’ ability to demonstrate the 

meaningful use of CEHRT for Stage 2. 

After consideration of the public 

comments received, we are finalizing 

this objective as proposed for EPs at 

§ 495.6(j)(6)(i) and for eligible hospitals 

and CAHs at § 495.6(l)(5)(i). 

Proposed Measure: We proposed two 

measures for EPs, eligible hospitals and 

CAHs for this objective. Both of the 

measures must be met in order for the 

provider to satisfy this objective: 

1. Implement five clinical decision 

support interventions related to five or 

more clinical quality measures at a 

relevant point in patient care for the 

entire EHR reporting period; and 

2. The EP, eligible hospital, or CAH 

has enabled and implemented the 

functionality for drug-drug and drugallergy interaction checks for the entire 

EHR reporting period. 

We proposed to make the Stage 1 

objective for ‘‘implement drug-drug and 

drug-allergy interaction checks’’ one of 

the measures of the CDS objective for 

Stage 2. Based on the HIT Policy 

Committee’s recommendation, we 

proposed that each CDS intervention 

must enable providers to review all of 

the following attributes for the 

intervention: developer of the 

intervention, bibliographic citation, 

funding source of the intervention, and 

the release or revision date of each 

intervention. The ONC standards and 

certification criteria final rule published 

elsewhere in this issue of the Federal 

Register provides additional 

information regarding the incorporation 

of the CDS in CEHRT. We proposed that 

providers must implement the CDS 

intervention at a relevant point in 

patient care when the intervention can 

influence clinical decisionmaking 

before an action is taken on behalf of the 

patient. We proposed that providers 

must implement five CDS interventions 

that they believe will result in 

improvement in performance for five or 

more of the clinical quality measures on 

which they report. If none of the clinical 

quality measures is applicable to an EP’s 

scope of practice, the EP should 

implement a CDS intervention that he or 

she believes will be effective in 

improving the quality, safety, or 

efficiency of patient care. 

Comment: Many commenters noted 

that at least one of the CDS 

interventions implemented should be 

tied to efficiency goals (for example, 

reducing the overuse of high-cost 

procedures). 

Response: While we believe that it is 

entirely possible for a CDS intervention 

to improve both the quality of care and 

improve healthcare efficiency, we agree 

with the suggestion that at least one 

intervention could be tied directly to 

improving the efficient use of healthcare 

resources. In considering whether a CDS 

intervention increases healthcare 

efficiency, providers can consider 

improvements in any healthcare 

process. Some examples, of CDS 

interventions that may lead to 

improvements in healthcare efficiency 

include, alerts when duplicate tests, 

procedures or treatments are ordered for 

the same patient, using clinical 

guidelines for direct patient care 

processes, documentation templates to 

reduce variability in recording and 

alerting when outside of specified 

parameters, and using evidence based 

pre-specified order sets for blood 

products. Therefore, we are modifying 

the proposed CDS measure such that 

four of the CDS interventions are related 

to four or more CQMs, and the fifth CDS 

intervention should be related to 

improving healthcare efficiency. We 

clarify that any of the five CDS 

interventions may be related to both 

CQMs and improving healthcare 

efficiency. 

Comment: Various comments were 

received in response to the proposed 

number of CDS interventions that are 

related to five or more CQMs. One 

commenter noted the potential for 

improved provider reporting and user 

efficiencies due to the inherent measure 

associations. Several commenters 

welcomed this improved alignment of 

CQM measures and reporting between 

the EHR Incentive Program and other 

CMS quality programs. Other 

commenters expressed the difficult 

burden for specialists and others who 

may not be able to identify sufficient 

CQMs related to their patient 

population. Still other comments 

suggested that providers could easily 

implement double the number of 

proposed CDS interventions. 

Response: Overall comments were 

supportive of the proposed number of 

CDS interventions and of aligning these 

interventions with CQM reporting. If 

none of the clinical quality measures are 

applicable to an EP’s scope of practice, 

the EP should implement a clinical 

decision support intervention that he or 

she believes will be effective in 

improving the quality, safety or 

efficiency of patient care. We believe 

that the proposed clinical quality 

measures for eligible hospitals and 

CAHs would provide ample opportunity 

for implementing clinical decision 

support interventions related to highpriority health conditions. 

Comment: Commenters also 

supported continuing the requirement 

for providers to enable and implement 

drug-drug and drug-allergy interaction 

checks for the entire reporting period 

under the new CDS measure. An AHA 

Survey indicated that 73 percent of 

hospitals could perform the drug/drug 

and drug/allergy check, as well as at 

least one additional clinical decision 

support function in the Fall of 2011. 

Response: We appreciate the 

commenters’ overall support for 

consolidating this Stage 1 objective into 

one of the required clinical decision 

support measures. We also agree that 

drug-drug and drug-allergy interaction 

checks are important CDS tools 

contributing to improvements in patient 

safety and the overall quality of patient 

care. 

Comment: Additional comments 

addressed concerns regarding the point 

at which professionals will be able to 

exercise clinical judgment about the 

CDS intervention before action is taken 

on behalf of the patient. The specific 

concern is that some interventions are 

only triggered when an action is about 

to be taken, and proposed that CMS 

revise this criterion to ‘‘before or at the 

time an action is taken.’’ 

Response: We agree with the 

commenter that providers should be 

allowed the flexibility to determine the 

most appropriate CDS intervention and 

timing of the CDS. The CDS measure for 

EPs, eligible hospitals and CAHs allows 

this flexibility by allowing the 

implementation at a ‘‘relevant point in 

patient care.’’ We clarify that the CDS 

implementation criterion which allow 

for CDS implementation at a relevant 

point in patient care includes 

interventions that may occur before or at 

the time an action is taken in the care 

delivery process. 

Comment: Several commenters 

expressed concern with ‘‘alert fatigue’’ 

associated with increased use of clinical 

decision support interventions. These 

commenters cited studies that suggest 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53997 

that multiple alerts may be disabled or 

ignored resulting in adverse effects in 

the quality of care and patient safety. 

Response: We recognize that ‘‘alert 

fatigue’’ is a potential occurrence with 

the increased use of some types of 

clinical decision support interventions. 

However, meaningful use seeks to 

leverage the capabilities of CEHRT to 

improve patient care. The selection of 

CDS interventions should weigh both 

the potential for unintended 

consequences including alert fatigue 

against the benefits of each CDS 

intervention, and the appropriate 

selection of an intervention type that 

interferes minimally with the provider’s 

clinical workflow and cognitive burden. 

We believe such determinations are best 

left to providers. CDS is included as a 

meaningful use objective because we 

believe that the overall benefit of CDS 

is to improve patient safety and the 

quality of care. Therefore, we will 

continue to require the implementation 

of clinical decision support 

interventions in order to achieve 

meaningful use. Finally, as defined in 

the ONC standards and certification 

criteria final rule published elsewhere 

in this issue of the Federal Register, 

CDS is ‘‘not simply an alert, 

notification, or explicit care 

suggestion.’’ While some alerts may be 

helpful and necessary, we encourage 

EPs and hospitals to consider the 

selection of CDS interventions that are 

not alerts in order to reduce the burden 

of alert fatigue. Examples of non-alert 

CDS may include patient or disease 

specific order sets, referential decision 

support (presentation or availability of 

clinical reference information such as 

diagnostic guidance, dosing guidelines, 

or lab value interpretation assistance, or 

patient or disease specific 

documentation forms/templates that 

remind the provider to capture essential 

historical or physical exam findings for 

a patient with a certain condition). A 

common example of a CDS form/ 

template would be a documentation 

form that is presented for patients with 

diabetes that includes a required section 

for the diabetic foot exam, where the 

same form would be presented for 

patients without diabetes and with the 

diabetic foot exam section removed. 

Comment: Several commenters 

requested the flexibility to be able to 

change CDS interventions at any point 

during the reporting period so that in 

effect they would not be implementing 

the CDS intervention during the entire 

reporting period. Commenters cited 

provider uncertainty at the beginning of 

a reporting period of which CQMs they 

will ultimately report during the 

attestation process (for example, due to 

low counts for the measures). Many 

commenters requested the additional 

flexibility for providers to be permitted 

to implement CDS interventions 

relevant to any of the finalized panel of 

clinical quality measures specific to the 

provider type, even if the provider 

ultimately chooses different clinical 

quality measures to report. Commenters 

requested the opportunity to change 

CDS interventions during the reporting 

period and not be penalized for the CDS 

measure that requires the intervention 

during the entire reporting period. 

Commenters also wanted clarification 

whether they have to align CDS 

interventions with the same CQM 

measures reported for meaningful use. 

Response: We expect providers to 

align CDS interventions with CQMs to 

the extent possible, although we 

recognize that providers may not know 

at the beginning of a reporting period 

which CQMs they will end up selecting 

to report. Based on the comments, we 

clarify that EPs and hospitals may 

implement CDS interventions that are 

related (as defined in the proposed rule) 

to any of the clinical quality measures 

for EPs and hospitals, respectively, and 

that are finalized for the EHR Incentive 

Program for the relevant year of 

reporting. In other words, providers are 

not required to implement CDS 

interventions that are related to the 

specific CQMs that they choose to report 

for that year. Providers who are not able 

to identify CQMs that apply to their 

scope of practice or patient population 

may implement CDS interventions that 

they believe are related to high-priority 

health conditions relevant to their 

patient population and will be effective 

in improving the quality, safety or 

efficiency of patient care. We will 

require providers to implement a 

minimum of five CDS interventions for 

the entire EHR reporting period. The 

provider may switch between CDS 

interventions or modify them during the 

EHR reporting period as long as a 

minimum of five are implemented for 

the entire EHR reporting period. We 

expect that providers may choose to 

implement a greater number of 

interventions from which they can 

select five interventions that have been 

enabled for the entire EHR reporting 

period when they attest to meaningful 

use. 

Comment: Several providers 

recommend to be allowed to use their 

clinical judgment regarding which 

clinical decision support interventions 

would best benefit patients within the 

scope of their practice. 

Response: We thank providers for this 

comment and want to clarify that in 

Stage 1; CMS allowed providers 

significant leeway in determining the 

clinical support interventions most 

relevant to their scope of practice. In 

Stage 2, we will continue to provide the 

flexibility for providers to identify highpriority health conditions that are most 

appropriate for CDS. As we stated in the 

proposed rule, for Stage 2 we will not 

require the provider to demonstrate 

actual improvements in performance on 

clinical quality measures for this 

objective. Because CQMs focus on highpriority health conditions by definition, 

to the extent possible, four of the five 

CDS interventions that are implemented 

must be related to CQMs. Providers are 

also reminded that the CDS 

interventions selected for Stage 2 

represent only a floor. We expect that 

providers will implement many CDS 

interventions, and providers are free to 

choose interventions in any domain that 

is a priority to the EP, eligible hospital 

or CAH. 

Comment: Several commenters voiced 

concern that CDS interventions must be 

predetermined at the beginning of an 

EHR reporting period but providers do 

not have to choose CQMs until the end 

of the attestation reporting period. There 

is concern that providers will be unable 

to change the CDS interventions if they 

decide to change the related CQMs in a 

reporting period. 

Response: We proposed alignment 

with CQMs to facilitate provider 

reporting and measurement, but as we 

clarified earlier, providers are allowed 

the flexibility to implement CDS 

interventions that are related to any of 

the CQMs that are finalized for the EHR 

Incentive Program. They are not limited 

to the CQMs they choose to report. 

Providers who are not able to identify 

CQMs that apply to their scope of 

practice or patient population may 

implement CDS interventions that they 

believe are related to high-priority 

health conditions relevant to their 

patient population and will be effective 

in improving the quality, safety or 

efficiency of patient care. These high 

priority conditions must be determined 

prior to the start of the EHR reporting 

period in order to implement the 

appropriate CDS to allow for improved 

performance. We require a minimum 

number of CDS interventions, and 

providers must determine whether a 

greater number of CDS interventions are 

appropriate for their patient 

populations. 

Comment: Commenters supported the 

inclusion of drug-drug and drug-allergy 

checks noting that they are critical to 

ensuring the safety of the medications 

prescribed for patients, and agree with 

the inclusion of this measure. Other 

commenters noted the lack of an for EPs 

mstockstill on DSK4VPTVN1PROD with RULES2

53998 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

who do not prescribe medications and 

thus would not be able to meet this core 

set objective. 

Response: We received similar 

feedback after publication of the Stage 1 

final rule and after careful consideration 

of the comments, we will allow an 

exclusion to this measure for EPs that 

write fewer than 100 medication orders 

during the EHR reporting period. We 

did not include this exclusion as a 

change to Stage 1 as this is primarily an 

implementation of a function of CEHRT 

and there is no requirement to update 

CEHRT in 2013. This exclusion aligns 

with the exclusion under the objective 

CPOE for medication orders discussed 

earlier in this rule. 

Comment: There were several 

comments regarding the implementation 

of CDS and the attributes required for 

each intervention. Commenters did not 

believe that the information requested 

in order to support the inclusion of CDS 

attributes would be available to many 

providers, particularly for providers in a 

group practice. Commenters also 

requested clarification whether these 

attributes would be required for drugdrug and drug-allergy interactions. 

Other commenters requested additional 

clarification regarding the extent that 

CDS attributes are required when the 

interventions result from self-generated 

evidence. Other comments addressed 

provider concerns regarding the need to 

purchase additional expensive vendor 

products and upgrades to incorporate 

these requirements. 

Response: We appreciate the many 

comments for the proposed CDS 

attributes. We clarify that the need for 

inclusion of attributes for each CDS 

intervention also applies to drug-drug 

and drug-allergy interventions as well as 

interventions based on self-generated 

evidence. The companion ONC 

standards and certification criteria final 

rule published elsewhere in this issue of 

the Federal Register further describes 

CEHRT requirements for these CDS 

attributes in order to ensure that all 

users of CEHRT will have access to this 

new functionality. After consideration 

of the public comments and for the 

reasons discussed earlier, we are 

modifying the measures for EPs at 

§ 495.6(j)(6)(ii) and for eligible hospitals 

and CAHs at § 495.6(l)(5)(ii) as follows: 

• Implement five clinical decision 

support interventions related to four or 

more clinical quality measures at a 

relevant point in patient care for the 

entire EHR reporting period. Absent 

four clinical quality measures related to 

an EP, eligible hospital or CAH’s scope 

of practice or patient population, the 

clinical decision support interventions 

must be related to high-priority health 

conditions . It is suggested that one of 

the five clinical decision support 

interventions be related to improving 

healthcare efficiency. 

• The EP, eligible hospital, or CAH 

has enabled and implemented the 

functionality for drug-drug and drugallergy interaction checks for the entire 

EHR reporting period. 

Exclusion: For the second measure, 

any EP who writes fewer than 100 

medication orders during the EHR 

reporting period. 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(a)(8) and (a)(2). 

Replaced Objective: Provide patients 

with an electronic copy of their health 

information. 

Replaced Objective: Provide patients 

with an electronic copy of their 

discharge instructions. 

For Stage 2, we did not propose the 

Stage 1 meaningful use objectives for 

EPs and hospitals to provide patients 

with an electronic copy of their health 

information and discharge instructions 

upon request. As we stated in the 

proposed rule, the HIT Policy 

Committee recommended that these 

objectives be combined with the 

objectives for view online, download, 

and transmit. We agreed with the HIT 

Policy Committee and proposed to 

replace the Stage 1 objectives above 

with objectives and measures for Stage 

2 that would enable patients to view 

online and download their health 

information and hospital admission 

information. We stated that continued 

online access to such information is 

more useful and provides greater 

accessibility over time and in different 

health care environments than a single 

electronic transmission or a one-time 

provision of an electronic copy, 

especially when that access is coupled 

with the ability to download a 

comprehensive point in time record. 

We received no comments that 

supported the retention of these 

objectives for Stage 2. Therefore, we are 

finalizing the replacement of these 

objectives for EPs, eligible hospitals, 

and CAHs as proposed. Please refer to 

the discussions later in this rule 

regarding view online, download, and 

transmit objectives for both EPs and 

eligible hospitals and CAHs for more 

information about the Stage 2 objectives 

that replace these Stage 1 objectives. 

Proposed EP Objective: Provide 

clinical summaries for patients for each 

office visit. 

In the proposed rule, we outlined the 

following benefits of providing clinical 

summaries for patients for each office 

visit: A summary of an office visit 

provides patients and their families 

with a record of the visit. This record 

can prove to be a vital reference for the 

patient and their caregivers about their 

health and actions they should be taking 

to improve their health. Without this 

reference, the patient must either recall 

each detail of the visit, potentially 

missing vital information, or contact the 

provider after the visit. Certified EHR 

technology enables the provider to 

create a summary easily and in many 

cases instantly. This capability removes 

nearly all of the barriers that exist when 

using paper records. 

As noted in the proposed rule, 

clinical summaries for each office visit 

are important because without this 

reference the patient must either recall 

each detail of the visit, potentially 

missing vital information, or contact the 

provider after the visit. We also noted 

that this is a meaningful use 

requirement, which does not override 

an individual’s broader right under 

HIPAA to access his or her health 

information. Providers must continue to 

comply with all applicable requirements 

under the HIPAA Privacy Rule, 

including the access provisions of 45 

CFR 164.524. However, none of the 

HIPAA access requirements preclude an 

EP from releasing electronic copies of 

clinical summaries to their patients as 

required by this meaningful use 

provision. For Stage 2, we proposed this 

as a core objective for EPs. 

Comment: Some commenters believed 

that this objective should be eliminated 

because the same information would be 

made available through the objective to 

‘‘Provide patients the ability to view 

online, download, and transmit their 

health information.’’ Other commenters 

suggested combining these objectives 

with a concomitant rise in the measure 

threshold. 

Response: While it is true that there 

may be overlap between the information 

in the clinical summary and the 

information made available through the 

objective to ‘‘Provide patients the ability 

to view online, download, and transmit 

their health information,’’ we believe 

the clinical summary after an office visit 

serves a different purpose than online 

access to health information. A 

summary of an office visit provides 

patients and their families with a record 

of the visit and specific lab tests or 

specific follow-up actions and treatment 

related to the visit. While this 

information is certainly part of the 

patient’s overall electronic health 

record, the clinical summary serves to 

highlight information that is relevant to 

the patient’s care at that particular 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 53999 

moment. Therefore, we decline to 

eliminate or combine the objective. 

After consideration of the public 

comments, we are finalizing the 

meaningful use objective for EPs at 

§ 495.6(j)(11)(i) as proposed. 

Proposed EP Measure: Clinical 

summaries provided to patients within 

24 hours for more than 50 percent of 

office visits. 

In the proposed rule, we proposed to 

maintain several policies regarding this 

objective from Stage 1. As we stated, for 

purposes of meaningful use, an EP 

could withhold information from the 

clinical summary if they believe 

substantial harm may arise from its 

disclosure through an after-visit clinical 

summary. An EP could also choose 

whether to offer the summary 

electronically or on paper by default, 

but at the patient’s request must make 

the other form available. The EP could 

select any modality (for example, 

online, CD, USB) as their electronic 

option and would not have to 

accommodate requests for different 

modalities. We also stated in the 

proposed rule that we do not believe it 

would be appropriate for an EP to 

charge the patient a fee for providing the 

summary. Finally, we stated that when 

a single consolidated summary is 

provided for an office visit that lasts for 

several consecutive days, or for an office 

visit where a patient is seen by multiple 

EPs, that office visit must be counted 

only once in both the numerator and 

denominator of the measure. We are 

finalizing all of these policies for Stage 

2 as proposed. 

Comment: Many commenters 

suggested that the measure should be 

changed from ‘‘24 hours’’ to ‘‘1 business 

day.’’ Other commenters believed that 

this timeframe was too short, especially 

for specialty providers who might not 

come into the office every day, and 

suggested either changing the timeframe 

to 48 hours or reverting to the 72-hour 

measure of Stage 1. Another commenter 

noted that delays past 24 hours can 

sometimes occur outside of the 

provider’s control—for example, in the 

case of new patients where the provider 

might not have access to adequate 

previous records. 

Response: We believe that Certified 

EHR technology enables the provider to 

create a summary with the required 

information easily and in most cases 

instantly. The feedback we have 

received on this objective in Stage 1 

through discussions with providers 

indicates that most providers make this 

clinical summary available as patients 

leave the office visit, and we expect this 

workflow to continue for most 

providers. Therefore a longer timeframe 

of 48 or 72 hours should not be 

necessary for providing clinical 

summaries. We also note that the 

clinical summary contains information 

relevant to the patient’s office visit and 

therefore the EP should not need to 

include information from previous 

records for most patients. However, we 

believe the threshold of more than 50 

percent of office visits allows EPs to 

meet the measure of this objective 

despite these challenges for a small 

number of patients. We also agree that 

the measure should be changed from 

‘‘24 hours’’ to ‘‘1 business day’’ since all 

providers may not have staff available to 

issue clinical summaries prior to the 

close of a work week or the beginning 

of a Federal holiday. Therefore, we are 

finalizing the change from ‘‘24 hours’’ to 

‘‘1 business day.’’ 

Comment: A number of commenters 

raised questions regarding the provision 

of the clinical summary. They asked 

whether the summary should be given 

automatically to each patient or whether 

offering the summary at the end of an 

office visit was sufficient to meet the 

measure. Commenters also asked 

whether patients who refused a copy of 

the clinical summary should be counted 

in the numerator of the measure. 

Response: It is the intention of this 

objective that clinical summaries be 

automatically given to patients within 1 

business day of an office visit. However, 

we do recognize that some patients may 

decline a physical copy of their clinical 

summary. In the event that a clinical 

summary is offered to and subsequently 

declined by the patient, that patient may 

still be included in the numerator of the 

measure. We note that the clinical 

summary must be offered to the patient; 

a passive indication of the clinical 

summary’s availability (for example, a 

sign at the reception desk, a note in 

form, etc.) would not serve as offering 

the clinical summary and those patients 

could not be counted in the numerator 

of the measure. However, the clinical 

summary does not necessarily need to 

be printed before being offered to the 

patient. 

Comment: Commenters asked 

whether making clinical summaries 

available on a patient portal or as part 

of the objective to ‘‘Provide patients the 

ability to view online, download, and 

transmit their health information’’ 

would meet the measure of this 

objective. Some commenters suggested 

that patients should be permitted to 

demand an electronic copy of clinical 

summaries where an EP has chosen to 

provide them in hard copy form. 

Response: We are continuing our 

policy from Stage 1 that the clinical 

summary can be provided through a 

patient portal or through other 

electronic means to satisfy this measure. 

A clinical summary provided through 

the same means that the provider makes 

other patient information available to 

meet the objective to ‘‘Provide patients 

the ability to view online, download, 

and transmit their health information’’ 

would also meet the measure of this 

objective. As stated previously, an EP 

can choose whether to offer the 

summary electronically or on paper by 

default, but at the patient’s request must 

make the other form available. The EP 

could select any modality (for example, 

online, CD, USB) as their electronic 

option and would not have to 

accommodate requests for different 

electronic modalities. 

Comment: Some commenters 

suggested that this measure should be 

based on the number of unique patients 

seen by the EP instead of office visits. 

Other commenters suggested that the 

threshold for the measure should be 

reduced. 

Response: We do not agree that the 

measure should be based on unique 

patients. The purpose of the clinical 

summary is to provide patients and 

their authorized representatives with a 

record of an office visit and specific lab 

tests or specific follow-up actions and 

treatment related to that visit. Nor do we 

agree that the percentage threshold of 

this measure should be reduced. We 

note that the threshold for this measure 

in Stage 1 was also 50 percent; any 

reduction would constitute a step 

backward for the meaningful use of this 

capability. 

Comment: Some commenters 

suggested that EPs should be permitted 

to charge a fee for provision of a clinical 

summary. 

Response: Because the clinical 

summary is meant to summarize the 

office visit and any lab tests, follow-up 

actions, or treatments related to that 

visit, we do not believe it is appropriate 

for an EP to charge patients additional 

fees for its provision. Also, because this 

is a meaningful use requirement for the 

incentivized provider and not a 

response to a patient request, we do not 

believe it is appropriate for an 

incentivized provider to charge the 

patient. This is consistent with our 

position for this objective in Stage 1 (75 

FR 44358). 

Comment: Commenters suggested that 

clinical summaries provided to patientauthorized representatives should also 

be counted for this measure. 

Response: We agree that the provision 

of a clinical summary to a patientauthorized representative should also be 

counted, and we have amended the 

measure accordingly. 

mstockstill on DSK4VPTVN1PROD with RULES2

54000 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

Comment: Many commenters believed 

that the list of required elements to be 

included in the clinical summary was 

excessive and not useful to the patient. 

Commenters suggested that the list be 

shortened or left to the provider’s 

discretion. Additionally, many 

commenters asked for clarification on 

whether certain fields could be left 

blank and still permit the EP to meet the 

measure of this objective. Finally, a 

number of commenters suggested that 

this objective should focus on whether 

the summary is provided and not on 

required information since CEHRT 

cannot distinguish between information 

not provided in a clinical summary 

because it is not relevant or because a 

provider has exercised discretion to 

withhold it. 

Response: This measure is focused on 

the provision of the clinical summary. 

The clinical summary represents a 

patient’s current care and health as a 

snapshot in time. When provided, we 

believe it can significantly improve a 

patient’s overall awareness of the care 

they are receiving as well as any 

conditions they may need to manage 

between office visits. The required 

information listed at the end of this 

section are provided as a way to 

standardize and prioritize for the 

purposes of EHR technology 

certification the minimum amount of 

information that must be available to 

EPs to select. Further, we believe that 

the information in this minimum list is 

the most applicable and beneficial to 

improving patient care. This is a list of 

information, not a particular structure or 

format for the summary handed to the 

patient. 

We have no requirements on the 

design of the summary just the 

information that must be present if it is 

in the CEHRT. The design of the 

summary should reflect the context of 

the visit. For example, the information 

of future appointments, referrals to 

other providers, future scheduled tests, 

and clinical instructions could all 

appear in a section of the summary 

called ‘‘Next steps’’. If all of these 

information areas were empty then 

‘‘next steps’’ could just be none and all 

the feeding information elements would 

be covered. Alternatively, if the 

summary is provided on letterhead that 

includes the office location and the 

provider’s name that information does 

not have to be repeated in the text of the 

summary. We cannot emphasize enough 

that this is required information for the 

summary not a particular required 

structure for the summary. We do not 

believe that the list of required 

information imposes an undue burden 

on providers because CEHRT will be 

able to automatically generate the 

clinical summary with at least all of the 

required information. In ONC’s rule it 

has included in the certification 

criterion that correlates to this objective 

the capability for end-users to customize 

(for example, edit) the clinical summary 

to make it more relevant to the patient 

encounter. 

In circumstances where there is no 

information available to populate one or 

more of the fields previously listed, 

either because the EP can be excluded 

from recording such information (for 

example, vital signs) or because there is 

no information to record (for example, 

no medication allergies or laboratory 

tests), an indication that the information 

is not available in the clinical summary 

would meet the measure of this 

objective. The feedback we have 

received on this objective in Stage 1 

through discussions with providers 

indicates that the absence of 

information in the clinical summary 

sometimes offers an opportunity for 

reconciliation of misinformation; for 

example, if ‘‘no medication allergies’’ is 

listed but the patient has one, he or she 

may communicate that to the provider, 

thus improving the quality of the data 

in the EHR. We do note that the measure 

of this objective already focuses on 

provision of the clinical summary and is 

not specific to the information which is 

provided within the clinical summary; 

the list of required elements is meant to 

standardize the information given to 

patients, not to create an additional 

measure for the objective. 

We also refer providers to our 

discussion of what constitutes an office 

visit. Many of the concerns we have 

heard regarding this summary are the 

result of misunderstandings about what 

constitutes an office visit. For example, 

in some cases removing sutures or 

giving allergy shots do not represent an 

office visit if that is the only service 

provided. 

Comment: Commenters asked for 

clarification on ‘‘current problem list 

and any updates,’’ ‘‘current medication 

list and any updates,’’ and ‘‘current 

medication allergy list and any 

updates,’’ since updates would be 

included in any current problem list. 

They suggested simplifying these 

requirements to ‘‘current problem list;’’ 

‘‘current medication list;’’ and ‘‘current 

medication allergy list’’. 

Response: We agree that including the 

language ‘‘and any updates’’ is 

redundant since a current problem, 

medication, or medication allergy list 

would already include updated 

information. We are amending this 

language in the list of required elements 

below. However, the clinical summary 

should include both a current problem 

list and any diagnosis specifically 

related to the office visit as separate 

fields. The diagnosis related to the office 

visit should be expressed in the ‘‘Reason 

for the patient’s visit’’ field, though it 

may also be included in the current 

problem list. We note that this is 

consistent documentation available in 

the Consolidated Clinical Document 

Architecture (CDA), which defines the 

‘‘Reason for the patient’s visit’’ field as 

the provider’s description of the reason 

for visit and the ‘‘Chief complaint field’’ 

as the patient’s own description. 

Comment: Commenters asked for 

clarification on ‘‘vital signs and any 

updates’’ and suggested simplifying this 

requirement to ‘‘Vitals taken during 

visit’’. 

Response: While we agree that vital 

signs taken during the visit would be 

most useful in the clinical summary, we 

also recognize that all vital signs may 

not be updated at each office visit. 

Therefore, we are amending this 

language to ‘‘Vital signs taken during 

the visit (or other recent vital signs)’’ in 

the list of required elements below. 

Comment: Commenters asked us to 

clarify if the requirement relating to the 

inclusion of laboratory test results 

applies only to test results available at 

the time of the office visit or to test 

results that become available after the 

clinical summary is issued. 

Response: By laboratory test results, 

we mean for the clinical summary to 

include results that are available at the 

time the clinical summary is issued to 

the patient. As we stated in the 

proposed rule, clinical summaries can 

quickly become out of date due to 

information not available to the EP at 

the end of the visit. The most common 

example of this is laboratory test results. 

We believe that EPs should make this 

information known to the patient when 

the results are available, but do not 

require that a new clinical summary 

must be issued when information needs 

to be updated. 

Comment: Commenters asked us to 

clarify if the list of diagnostic tests 

pending indicates diagnostic tests that 

have been scheduled or diagnostic tests 

for which results are not yet available. 

Response: Diagnostic tests pending 

refers to diagnostic tests that have been 

performed but for which results are not 

yet available. Laboratory or diagnostic 

tests that have been scheduled but not 

yet performed should be recorded under 

‘‘Future scheduled tests’’ in the list of 

required elements later in this section. 

Comment: Some commenters asked us 

to define clinical instructions. Other 

commenters asked if the instructions 

included as part of the care plan were 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54001 

redundant with the ‘‘clinical 

instructions’’ element in the list of 

required information. 

Response: By clinical instructions we 

mean care instructions for the patient 

that are specific to the office visit. 

Although we recognize that these 

clinical instructions at times may be 

identical to the instructions included as 

part of the care plan, we also believe 

that care plans may include additional 

instructions that are meant to address 

long-term or chronic care issues, 

whereas clinical instructions specific to 

the office visit may be related to acute 

patient care issues. Therefore, we 

maintain these as separate items in the 

list of required elements later. 

Comment: A commenter noted that 

future appointments and future 

scheduled tests might be stored in a 

scheduling system that is separate from 

CEHRT and suggested that if the 

information is not available in CEHRT 

that the EP be excluded from having to 

provide it as part of the clinical 

summary. 

Response: As noted previously, in 

circumstances where there is no 

information available to populate one or 

more of the fields previously listed, 

either because the EP can be excluded 

from recording such information (for 

example, vital signs) or because there is 

no information to record (for example, 

no medication allergies or laboratory 

tests), an indication that the information 

is not available in the clinical summary 

would meet the measure of this 

objective. This would also be true if the 

information is not accessible through 

CEHRT. 

Comment: Commenters asked for 

clarification regarding demographics 

‘‘maintained by EP.’’ Specifically, they 

asked whether the EP was required to 

enter demographics or whether these 

could be maintained by a member of his 

or her staff. 

Response: By demographics we mean 

the demographics maintained within 

CEHRT. We do not intend to specify 

that only the EP can enter such 

information into the EHR; demographic 

information can be entered into CEHRT 

by any person or through any electronic 

interface with another system. 

Therefore, we are amending the 

language to ‘‘Demographic information 

maintained within CEHRT’’ in our list 

of required elements later in this 

section. 

Comment: In regard to the inclusion 

of ‘‘care plan field’’ in the list of 

required information, some commenters 

believed that the wording was overly 

prescriptive since CEHRT could utilize 

multiple fields to structure care plans. 

Other commenters requested a more 

detailed definition of care plan. 

Response: We agree that the language 

proposed could be viewed as 

prescriptive, and we do not intend to 

limit the inclusion of the care plan to a 

single field. Therefore, we are amending 

the language to ‘‘Care plan field(s), 

including goals and instructions’’ in our 

list of required elements below. 

However, we decline to provide an 

alternate definition that would limit the 

information in the care plan. We believe 

that the definition we proposed in the 

proposed rule is sufficient to allow for 

the inclusion of a variety of care plans 

in the clinical summary. For purposes of 

the clinical summary, we define a care 

plan as the structure used to define the 

management actions for the various 

conditions, problems, or issues. A care 

plan must include at a minimum the 

following components: problem (the 

focus of the care plan), goal (the target 

outcome) and any instructions that the 

provider has given to the patient. A goal 

is a defined target or measure to be 

achieved in the process of patient care 

(an expected outcome). 

Comment: Some commenters asked 

for clarification about what is meant by 

patient decision aids. 

Response: By patient decision aids we 

mean any educational resource or tool 

that the provider believes can inform 

patient decisions about their own care. 

An example is an educational handout 

on the pros and cons of having surgery 

for a particular condition. 

Comment: Some commenters noted 

that because EHRs capture medical data, 

they will produce clinical summaries 

with medical terminology, whereas 

patients should receive summaries with 

nonmedical terminology and 

descriptions of both medications and 

lab test results that are easy to read and 

contain actionable items. 

Response: While we agree that 

clinical summaries with nonmedical 

terminology and extended descriptions 

would be most beneficial to patients, we 

also believe that the utility of this 

objective must be balanced against the 

potential burden it places on EPs. Since 

clinical summaries can be automatically 

generated from existing data in CEHRT, 

this removes significant workflow 

barriers to providing a summary for 

patients. We believe that requiring 

providers or their staff to render all 

information in the clinical summary 

into nonmedical terms at this time 

would impose a significant burden on 

providers and reduce the number of 

clinical summaries that providers make 

available to patients, thereby reducing 

the effectiveness of this objective. 

However, we note that most of the 

information that is required as part of 

the clinical summary should be easily 

understandable by most patients. Also, 

there is nothing to prevent an EP from 

providing additional information if he 

or she believes it would be more 

effective for the overall quality of 

patient care. We further note that we 

anticipate that the capabilities of 

CEHRT may soon allow for the 

provision of non-medical terminology 

and extended descriptions and we are 

considering adding this requirement in 

future stages of meaningful use. 

Comment: One commenter noted that 

the clinical summary contains a vast 

amount of protected health information 

(PHI) which could be compromised if 

patients discard the clinical summary 

insecurely. The commenter suggested 

requiring the clinical summary only for 

those patients who affirm they want it 

to eliminate any provider responsibility 

for security of the information. 

Response: We do not believe that 

making protected health information 

available to patients in any way 

compromises either patients or 

providers. On the contrary, we believe 

that offering this information is critical 

to improving the overall quality of 

patient care by offering specific followup instructions, test results, and care 

plan information to patients so that they 

can actively participate in their own 

care. We believe that providers can take 

steps to inform patients about the need 

to securely dispose of PHI, and we 

further note that making clinical 

summaries available electronically 

through an online portal or other means 

can be used to keep such PHI secure. 

Therefore, we decline to change the 

measure for this objective. 

After consideration of the public 

comments, we are finalizing the 

meaningful use measure for EPs as 

‘‘Clinical summaries provided to 

patients or patient-authorized 

representatives within 1 business day 

for more than 50 percent of office visits’’ 

at § 495.6(j)(11)(ii). 

We further specify that in order to 

meet this objective and measure, an EP 

must use the capabilities and standards 

of CEHRT at 45 CFR 170.314(e)(2). 

We clarify that the following 

information (or an indication that there 

is no information available) is required 

to be part of the clinical summary for 

Stage 2: 

• Patient name. 

• Provider’s name and office contact 

information. 

• Date and location of the visit. 

• Reason for the office visit. 

• Current problem list. 

• Current medication list. 

• Current medication allergy list. 

mstockstill on DSK4VPTVN1PROD with RULES2

54002 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

• Procedures performed during the 

visit. 

• Immunizations or medications 

administered during the visit. 

• Vital signs taken during the visit (or 

other recent vital signs). 

• Laboratory test results. 

• List of diagnostic tests pending. 

• Clinical instructions. 

• Future appointments. 

• Referrals to other providers. 

• Future scheduled tests. 

• Demographic information 

maintained within CEHRT (sex, race, 

ethnicity, date of birth, preferred 

language). 

• Smoking status 

• Care plan field(s), including goals 

and instructions. 

• Recommended patient decision aids 

(if applicable to the visit). 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of office 

visits conducted by the EP during the 

EHR reporting period. 

• Numerator: Number of office visits 

in the denominator where the patient or 

a patient-authorized representative is 

provided a clinical summary of their 

visit within 1 business day. 

• Threshold: The resulting percentage 

must be more than 50 percent in order 

for an EP to meet this measure. 

• Exclusion: Any EP who has no 

office visits during the EHR reporting 

period. 

Removed Objective: Capability to 

exchange key clinical information. 

In Stage 2, we proposed to move to 

actual use cases of electronic exchange 

of health information through the 

following objective: ‘‘The EP, eligible 

hospital or CAH who transitions their 

patient to another setting of care or 

provider of care or refers their patient to 

another provider of care should provide 

summary care record for each transition 

of care or referral.’’ We also proposed to 

remove this objective for Stage 1 as well, 

but requested comments on other 

options. Please refer to the section titled 

‘‘Changes to Stage 1’’ at II.A.3.b. of this 

final rule for details of the options 

considered. We are finalizing the 

removal of this objective as proposed in 

favor of the more robust, actual use case 

of electronic exchange through a 

summary of care record following each 

transition of care or referral. We believe 

that this actual use case is not only 

easier for providers to understand but it 

is also more beneficial because it 

contributes directly to the care of the 

patient through enhanced coordination 

between providers. A prudent provider 

will be preparing and testing to conduct 

actual exchange prior to the start of 

Stage 2 during their Stage 1 EHR 

reporting periods. 

Proposed Objective: Protect electronic 

health information created or 

maintained by the CEHRT through the 

implementation of appropriate technical 

capabilities. 

In the proposed rule, we outlined the 

following benefits of protecting health 

information: Protecting electronic health 

information is essential to all other 

aspects of meaningful use. Unintended 

and/or unlawful disclosures of personal 

health information could diminish 

consumers’ confidence in EHRs and 

electronic health information exchange. 

Ensuring that health information is 

adequately protected and secured will 

assist in addressing the unique risks and 

challenges that may be presented by 

electronic health records. 

Comment: A number of commenters 

supported the continued inclusion of 

this objective, yet several commenters 

requested the elimination of this 

objective as redundant to HIPAA 

regulations. 

Response: We believe that it is crucial 

that EPs, eligible hospitals, and CAHs 

evaluate the privacy and security 

implications of CEHRT as part of the 

EHR Incentive Programs, particularly as 

they pertain to 45 CFR 164.308(a)(1) and 

the protection and safeguarding of 

personal health information in general. 

Therefore, we retain this objective and 

measure for meaningful use in the final 

rule. 

After consideration of the public 

comments, we are finalizing the 

meaningful use objective for EPs at 

§ 495.6(j)(16)(i) and eligible hospitals 

and CAHs at § 495.6(l)(15)(i) as 

proposed. 

Proposed Measure: Conduct or review 

a security risk analysis in accordance 

with the requirements under 45 CFR 

164.308(a)(1), including addressing the 

encryption/security of data at rest in 

accordance with requirements under 45 

CFR 164.312(a)(2)(iv) and 45 CFR 

164.306(d)(3), and implement security 

updates as necessary and correct 

identified security deficiencies as part 

of the provider’s risk management 

process. 

In the proposed rule, we explained 

that this measure is the same as in Stage 

1 except that we specifically address the 

encryption/security of data is that is 

stored in CEHRT (data at rest). Due to 

the number of breaches reported to HHS 

involving lost or stolen devices, the HIT 

Policy Committee recommended 

specifically highlighting the importance 

of an entity’s reviewing its encryption 

practices as part of its risk analysis. We 

agree that this is an area of security that 

appears to need specific focus. Recent 

HHS analysis of reported breaches 

indicates that almost 40 percent of large 

breaches involve lost or stolen devices. 

Had these devices been encrypted, their 

data would have been secured. It is for 

these reasons that we specifically call 

out this element of the requirements 

under 45 CFR 164.308(a)(1) for the 

meaningful use measure. We did not 

propose to change the HIPAA Security 

Rule requirements, or require any more 

than is required under HIPAA. We only 

emphasize the importance of an EP or 

hospital including in its security risk 

analysis an assessment of the reasonable 

and appropriateness of encrypting 

electronic protected health information 

as a means of securing it, and where it 

is not reasonable and appropriate, the 

adoption of an equivalent alternative 

measure. 

We proposed this measure because 

the implementation of CEHRT has 

privacy and security implications under 

45 CFR 164.308(a)(1). A review must be 

conducted for each EHR reporting 

period and any security updates and 

deficiencies that are identified should 

be included in the provider’s risk 

management process and implemented 

or corrected as dictated by that process. 

In the proposed rule, we emphasized 

that our discussion of this measure and 

45 CFR 164.308(a)(1) is only relevant for 

purposes of the meaningful use 

requirements and is not intended to 

supersede what is separately required 

under HIPAA and other rulemaking. 

Compliance with the HIPAA 

requirements is outside of the scope of 

this rulemaking. Compliance with 42 

CFR Part 2 and state mental health 

privacy and confidentiality laws is also 

outside the scope of this rulemaking. 

EPs, eligible hospitals or CAH affected 

by 42 CFR Part 2 should consult with 

the Substance Abuse and Mental Health 

Services Administration (SAMHSA) or 

state authorities. 

Comment: Some commenters asked if 

the Stage 2 requirements for this 

objective contradict earlier Stage 1 

requirements and HIPAA regulations. 

Specifically, the addition of addressing 

encryption/security of data at rest to the 

measure was raised as a concern. 

Response: We do not believe that the 

Stage 2 measure of this objective 

contradicts either the Stage 1 measure or 

current HIPAA regulations. As noted in 

the proposed rule, this measure is the 

same as in Stage 1 except that we 

specifically highlight the encryption/ 

security of data that is stored in CEHRT 

(data at rest). Recent HHS analysis of 

reported breaches indicates that almost 

40 percent of large breaches (breaches 

affecting 500 or more individuals) 

involve lost or stolen devices. Had these 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54003 

devices been encrypted, their data 

would have been secured. It is for these 

reasons that we specifically call out this 

requirement under 45 CFR 

164.308(a)(1). We did not propose to 

change the HIPAA Security Rule 

requirements, or require any more under 

this measure than is required under 

HIPAA. We only emphasize the 

importance of an EP or hospital 

including in its security risk analysis an 

assessment of the reasonable and 

appropriateness of encrypting electronic 

protected health information as a means 

of securing it, and where it is not 

reasonable and appropriate, the 

adoption of an equivalent alternative 

measure. 

Comment: Several commenters asked 

for clarification of what constitutes an 

acceptable security risk analysis. 

Commenters also asked if the security 

risk analysis required in the measure 

should apply to health data stored in 

data centers with physical security. 

Response: We did not propose to 

change the HIPAA Security Rule 

requirements or impose additional 

requirements under this measure than 

those required under HIPAA. A review 

must be conducted for each EHR 

reporting period and any security 

updates and deficiencies that are 

identified should be included in the 

provider’s risk management process and 

implemented or corrected as dictated by 

that process. We refer providers to the 

requirements under 45 CFR 

164.308(a)(1), including addressing the 

encryption/security of data at rest in 

accordance with requirements under 45 

CFR 164.312(a)(2)(iv) and 45 CFR 

164.306(d)(3), of the HIPAA Security 

Rule for compliance. The HHS Office for 

Civil Rights (OCR) has issued guidance 

on conducting a security risk 

assessment pursuant to the HIPAA 

Security Rule (http://www.hhs.gov/ocr/ 

privacy/hipaa/administrative/ 

securityrule/rafinalguidancepdf.pdf). 

The scope of the security risk analysis 

for purposes of this meaningful use 

measure applies only to data created or 

maintained by CEHRT. This measure 

does not apply to data centers that are 

not part of CEHRT. However, we note 

that such data centers may be subject to 

the security requirements under 45 CFR 

164.308(a)(1) and refer providers to the 

HIPAA Security Rule for compliance 

information. 

Comment: One commenter asked if 

the measure of the objective required 

hospitals to report on data encryption 

methods. 

Response: No, eligible hospitals and 

CAHs are not required to report to CMS 

or the states on specific data encryption 

methods used. However, they are 

required to address the encryption/ 

security of data at rest in accordance 

with requirements under 45 CFR 

164.312(a)(2)(iv) and 45 CFR 

164.306(d)(3). 

Compliance with 42 CFR Part 2 and 

state mental health privacy and 

confidentiality laws is also outside the 

scope of this rulemaking. EPs, eligible 

hospitals or CAH affected by 42 CFR 

Part 2 should consult with the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) or 

state authorities. 

We are making a change in this final 

rule to the language of ‘‘data at rest’’ to 

specify our intention of data that is 

stored in CEHRT. After consideration of 

the public comments, we are finalizing 

the meaningful use measure as 

‘‘Conduct or review a security risk 

analysis in accordance with the 

requirements under 45 CFR 

164.308(a)(1), including addressing the 

encryption/security of data stored in 

CEHRT in accordance with 

requirements under 45 CFR 

164.312(a)(2)(iv) and 45 CFR 

164.306(d)(3), and implement security 

updates as necessary and correct 

identified security deficiencies as part 

of the provider’s risk management 

process’’ for EPs ‘‘at § 495.6(j)(16)(ii) 

and eligible hospitals and CAHs at 

§ 495.6(l)(15)(ii). 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(d)(1) through 

170.314(d)(8). 

(b) Objectives and Measures Carried 

Over (Modified or Unmodified) from 

Stage 1 Menu Set to Stage 2 Core Set 

We signaled our intent in the Stage 1 

final rule to move the objectives from 

the Stage 1 menu set to the Stage 2 core 

set. The HIT Policy Committee also 

recommended that we move all of these 

objectives to the core set for Stage 2. We 

proposed to include in the Stage 2 core 

set all of the objectives and associated 

measures from the Stage 1 menu set, 

except for the objective ‘‘capability to 

submit electronic syndromic 

surveillance data to public health 

agencies’’ for EPs, which will remain in 

the menu set for Stage 2. As discussed 

later, we also proposed to modify and 

combine some of these objectives and 

associated measures for Stage 2— 

Consolidated Objective: Implement 

drug formulary checks. 

For Stage 2, we proposed to include 

this objective within the core objective 

for EPs ‘‘Generate and transmit 

permissible prescriptions electronically 

(eRx)’’ and the menu objective for 

eligible hospitals and CAHs of 

‘‘Generate and transmit permissible 

discharge prescriptions electronically 

(eRx).’’ We believe that drug formulary 

checks are most useful when performed 

in combination with e-prescribing, 

where such checks can allow the EP or 

hospital to increase the efficiency of 

care and benefit the patient financially. 

We address the comments related to 

these proposals and state our final 

policy in the discussions of the eRx 

objectives for EPs and hospitals. 

Proposed Objective: Incorporate 

clinical lab test results into CEHRT as 

structured data. 

We propose to continue the policy 

from Stage 1 to incorporate clinical lab 

test results into CEHRT as structured 

data. We believe this measure 

contributes to the exchange of health 

information between providers of care, 

facilitates the sharing of information 

with patients and their designated 

representatives, and may reduce order 

entry errors which will contribute to 

patient care improvements. 

We did not receive any comments for 

this objective. We are finalizing the 

meaningful use objective for EPs at 

§ 495.6(j)(7)(i) and eligible hospitals and 

CAHs at § 495.6(l)(6)(i) as proposed. 

Proposed Measure: More than 55 

percent of all clinical lab tests results 

ordered by the EP or by authorized 

providers of the eligible hospital or CAH 

for patients admitted to its inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period whose 

results are either in a positive/negative 

or numerical format are incorporated in 

CEHRT as structured data. 

We proposed to increase the measure 

threshold from more than 40 percent for 

Stage 1 to more than 55 percent for 

Stage 2. We also solicited public 

comment regarding the feasibility of 

continuing to account for individual lab 

tests separately from group and panel 

tests. In addition, we solicited comment 

on whether standards and other 

capabilities would allow for the 

expansion of this measure to include all 

quantitative lab results. 

Comment: Many of the commenters 

voiced their concern that not all EHRs 

are capable of splitting out individual 

test results from panel tests and that it 

would not be feasible to require this for 

Stage 2 of meaningful use. Other 

commenters suggested modifying the 

current measure to use the number of 

laboratory test results in the EHR as the 

numerator and the total laboratory test 

results from the Lab Information System 

as the denominator. Others questioned 

the validity of the current measure that 

counts orders in the denominator and 

results in the numerator. Another 

comment is that not all providers have 

mstockstill on DSK4VPTVN1PROD with RULES2

54004 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

access to a lab interface system and not 

all lab interfaces are compatible. 

Response: We appreciate the many 

comments and suggestions submitted 

regarding this measure which were 

carefully considered as we developed 

the final regulation. Some commenters 

questioned the measure validity 

suggesting that the measure is imperfect 

since the numerator and denominator 

are incongruent. However, in 

considering the broader policy goal 

underlying this measure (to incorporate 

lab results into CEHRT in a standard 

format) the measure needs to be broad 

enough to allow providers to 

incorporate laboratory orders and 

results from multiple service providers. 

By incorporating all lab orders (whether 

panel or individual) in the denominator, 

and all lab test results in the numerator, 

providers will be able to capture 

structured lab data from a broad range 

of provider laboratory information 

systems into the CEHRT. We understand 

that the most likely scenario is that the 

denominator of total lab orders (if panel 

orders are counted as one) will be less 

than the numerator of laboratory results 

because results are provided for each 

individual test rather than by panel. 

Therefore, it is highly unlikely that the 

measure would impact a provider’s 

ability to meet the increased threshold 

in this scenario. 

Providers will need to continue to 

report individual lab test results 

recorded as structured data in the 

numerator, and in the denominator 

report all individual lab-tests ordered 

whether or not they are ordered 

individually or as part of a panel or 

group lab order. For example, one panel 

order of ten individual lab tests could be 

counted as 1 or 10 lab tests ordered in 

the denominator depending on the 

system that is used to incorporate this 

data into the CEHRT. We will monitor 

provider experience with this measure 

as technological capacity for the 

reporting and exchange of lab data 

continues to evolve. 

Comment: Other commenters 

mentioned uncertainty regarding the 

proper vocabulary to use for the 

incorporation of lab test results in a 

structured format. Several commenters 

went on to mention that there is not one 

current vocabulary that encompasses all 

types of tests. Another comment 

proposed that CMS work to amend the 

clinical laboratory improvement 

amendments (CLIA) to require hospital 

labs to report results in standard 

vocabulary such as the Logical 

Observation Identifiers Names and 

Codes System (LOINC) by the time Stage 

2 is implemented in 2014. 

Response: We refer readers to the 

ONC standards and certification criteria 

final rule published elsewhere in this 

issue of the Federal Register for 

vocabulary specifications. 

Comment: Many commenters were 

confused by the clarification CMS 

provided in the proposed rule for 

expanding the measure to all 

quantitative results (all results that can 

be compared on as a ratio or on a 

difference scale). Comments were mixed 

on whether this measure should include 

all types of lab tests that produce 

quantitative results. One commenter 

suggested CMS should allow ordinal 

responses for the measure since that is 

what LOINC uses as the response rather 

than counting test results with either a 

positive, negative or numeric response 

since operationally, counting tests based 

on whether or not they have two 

allowed answer choices is difficult, 

where counting tests based on whether 

the LOINC code for them had a Scale of 

QN or Ord would be quite simple. 

Another commenter suggested most 

people would assume that ‘‘numeric/ 

quantitative tests’’ would include 

decimals and whole numbers as well as 

results reported in a range (for example, 

>7.4 or <150) and ratios such as also 

titer levels (for example, 1:128). 

Response: We appreciate the number 

of comments regarding an expansion of 

the existing measure as well as further 

clarification. Based on both CMS and 

companion ONC comments received, 

we clarify that the measure incorporate 

all numeric/quantitative tests that report 

whole or decimal numbers. The 

structured data for the numeric/ 

quantitative test results may include 

positive or negative affirmations and/or 

numerical format that would include a 

reference range of numeric results and/ 

or ratios. 

Comment: Most commenters agreed 

that the increase measure threshold is 

appropriate. One commenter referenced 

a recent AHA survey that found ‘‘60 

percent of hospitals could perform this 

function in Fall 2011 at the raised 

threshold’’. 

Response: Our analysis of the Stage 1 

attestation data shows that 91.5 percent 

of EPs and 95 percent of eligible 

hospitals and CAHs were able to 

successfully demonstrate meaningful 

use for this measure. Therefore, 

combined with the AHA survey data 

results, we will adopt the proposed 

threshold of 55 percent or more for this 

measure. 

After consideration of the public 

comments received, we modify the 

measure for EPs at § 495.6(j)(7)(ii) and 

eligible hospitals and CAHs at 

§ 495.6(l)(6)(ii) to: 

More than 55 percent of all clinical 

lab tests results ordered by the EP or by 

authorized providers of the eligible 

hospital or CAH for patients admitted to 

its inpatient or emergency department 

(POS 21 or 23) during the EHR reporting 

period whose results are either in a 

positive/negative affirmation or 

numerical format are incorporated in 

CEHRT as structured data. 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(b)(5). 

• Denominator: Number of lab tests 

ordered during the EHR reporting 

period by the EP or by authorized 

providers of the eligible hospital or CAH 

for patients admitted to its inpatient or 

emergency department (POS 21 or 23) 

whose results are expressed in a 

positive or negative affirmation or as a 

number. 

• Numerator: Number of lab test 

results which are expressed in a positive 

or negative affirmation or as a numeric 

result which are incorporated in CEHRT 

as structured data. 

• Threshold: The resulting percentage 

must be more than 55 percent in order 

for an EP, eligible hospital, or CAH to 

meet this measure. 

• Exclusion: Any EP who orders no 

lab tests where results are either in a 

positive/negative affirmation or numeric 

format during the EHR reporting period. 

There is no exclusion available for 

eligible hospitals and CAHs because we 

do not believe any hospital will ever be 

in a situation where its authorized 

providers have not ordered any lab tests 

for admitted patients during an EHR 

reporting period. 

Proposed Objective: Generate lists of 

patients by specific conditions to use for 

quality improvement, reduction of 

disparities, research, or outreach. 

In the proposed rule, we outlined the 

following benefits of generating lists of 

patients by specific conditions: 

Generating patient lists is the first step 

in proactive management of populations 

with chronic conditions and is critical 

to providing accountable care. The 

ability to look at a provider’s entire 

population or a subset of that 

population brings insight that is simply 

not available when looking at patients 

individually. Small variations that are 

unnoticeable or seem insignificant on an 

individual basis can be magnified when 

multiplied across a population. A 

number of studies have shown that 

significant improvements result merely 

due to provider awareness of population 

level information. We believe that many 

EPs and eligible hospitals will use these 

reports in combination with one of the 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54005 

selected quality measures and decision 

support interventions to improve 

quality for a high priority issue (for 

example, identify patients who are in 

the denominator for a measure, but not 

the numerator, and in need of an 

intervention). The capabilities and 

variables used to generate the lists are 

defined in the ONC standards and 

certification final rule published 

elsewhere in this issue of the Federal 

Register; not all capabilities and 

variables must be used for every list. 

We have combined the comments and 

responses for this objective with the 

measure below. After consideration of 

the public comments, we are finalizing 

the meaningful use objective for EPs at 

§ 495.6(j)(8)(i) and eligible hospitals and 

CAHs at § 495.6(l)(7)(i) as proposed. 

Proposed Measure: Generate at least 

one report listing patients of the EP, 

eligible hospital, or CAH with a specific 

condition. 

We proposed to continue our Stage 1 

policies for this measure. The objective 

and measure do not dictate the specific 

report(s) that must be generated, as the 

EP, eligible hospital, or CAH is best 

positioned to determine which reports 

are most useful to their care efforts. The 

report used to meet the measure can 

cover every patient or a subset of 

patients. We believe there is no EP, 

eligible hospital, or CAH that could not 

benefit their patient population or a 

subset of their patient population by 

using such a report to identify 

opportunities for quality improvement, 

reductions in disparities of patient care, 

or for purposes of research or patient 

outreach; therefore, we did not propose 

an exclusion for this measure. The 

report can be generated by anyone who 

is on the EP’s or hospital’s staff during 

the EHR reporting period. We also 

solicited comment on whether a 

measure that either increases the 

number and/or frequency of the patient 

lists will further the intent of this 

objective. 

Comment: Most commenters voiced 

support for the objective and measure 

and wish it to remain unchanged in the 

final rule, although some commenters 

stated that the measure should only 

require demonstration that a list can be 

created and not require a certain 

number of patient lists until the needs 

to create certain patient lists are better 

ascertained. 

Response: We appreciate the support 

for this objective, and we note that the 

measure of the objective remains 

unchanged from Stage 1. Demonstration 

only of the capability to generate lists of 

patients by specific conditions would 

represent a step backward from the 

Stage 1 measure, therefore we do not 

agree that this would be an appropriate 

measure for Stage 2. We also believe 

there is ample evidence to support the 

use of patient lists in a variety of quality 

improvement efforts. 

Comment: Some commenters 

suggested that the measure requirements 

should be increased, either to require 

more than one report be generated 

during the EHR reporting period or to 

require that the report generated is 

linked to one of the EP’s or eligible 

hospital’s clinical decision support 

interventions. Another commenter 

suggested that the measure should 

indicate how the list should be used. 

Response: We believe that moving the 

objective from the menu set to the core 

represents an adequate increase for 

Stage 2. We also continue to believe that 

an EP, eligible hospital, or CAH is best 

positioned to determine which reports 

are most useful to their care efforts. 

Therefore, we do not propose to direct 

certain reports be created or link reports 

to clinical decision support 

interventions at this time. 

Comment: Some commenters 

suggested that lists should be generated 

according to specific clinical conditions 

or include specific elements, such as 

demographics, to aid analysis. One 

commenter wanted to know whether 

EPs retain flexibility in deciding the 

lists they generate, particularly in 

coordinating public health activities 

with state and local public health 

departments and Medicaid agencies. 

Another commenter suggested that the 

measure of the objective specify the 

continuous use of the report throughout 

the EHR reporting period. 

Response: As noted previously, we 

are continuing our policy from Stage 1 

that an EP, eligible hospital, or CAH is 

best positioned to determine which 

reports are most useful to their care 

efforts. Therefore, we do not propose to 

direct certain reports be created, nor do 

we require that specific conditions or 

elements be required for the reports. 

Also, we do not set requirements for the 

frequency of use of the report. 

Comment: A commenter asked us to 

clarify whether the EP must generate the 

patient list or if the patient list could be 

generated by a member of the EP’s staff 

in order to meet the measure. 

Response: For this and most 

meaningful use objectives, we do not 

specify how information must be 

entered into CEHRT or who must 

complete the required action to meet the 

measure. Therefore an EP or a member 

of the EP’s staff could generate the list 

and meet this measure. The exception to 

this rule is for computerized provider 

order entry (CPOE) of medication, 

laboratory, and radiology orders, which 

must be entered by a licensed healthcare 

professional per state, local, and 

professional guidelines. 

After consideration of the public 

comments, we are finalizing the 

meaningful use measure for EPs at 

§ 495.6(j)(8)(ii) and eligible hospitals 

and CAHs at § 495.6(l)(7)(ii) as 

proposed. 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(a)(14). 

Proposed EP Objective: Use clinically 

relevant information to identify patients 

who should receive reminders for 

preventive/follow-up care. 

In the proposed rule, we described the 

following benefits of this objective. By 

proactively reminding patients of 

preventive and follow-up care needs, 

EPs can increase compliance. These 

reminders are especially beneficial 

when long time lapses may occur as 

with some preventive care measures and 

when symptoms subside, but additional 

follow-up care is still required. 

We also proposed to revise this 

objective for Stage 2 to ‘‘Use clinically 

relevant information to identify patients 

who should receive reminders for 

preventive/follow-up care’’ based on the 

HITPC recommendation. An EP should 

use clinically relevant information 

stored within the CEHRT to identify 

patients who should receive reminders. 

We believe that the EP is best positioned 

to decide which information is 

clinically relevant for this purpose. 

Comment: A commenter stated that 

the language in the proposed objective 

is in conflict with the proposed 

measure. The proposed objective is to 

‘‘Use clinically relevant information to 

identify patients who should receive 

reminders for preventive/follow-up,’’ 

with no indication that the reminder be 

sent. However, the proposed measure 

refers to ‘‘patient who had an office visit 

and were sent a reminder, per patient 

preference.’’ 

Response: We agree with the 

commenter that the objective as 

proposed only speaks to the 

identification of the need for the 

reminder and that the proposed measure 

requires that the reminder be sent. The 

value of this objective is created when 

the reminder is sent to the patient and 

therefore, we revise the objective 

accordingly. 

Comment: Commenters requested 

request clarification of the operative 

definition of ‘‘reminder.’’ Remembering 

to keep the appointment is an important 

first step to follow-up and preventive 

care and therefore should be counted. 

mstockstill on DSK4VPTVN1PROD with RULES2

54006 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

Response: We believe that reminders 

should be limited to new actions that 

need to be taken not of actions that are 

already taken. For example, a reminder 

to schedule your next mammogram is a 

reminder to take action, while a 

reminder that your next mammogram is 

scheduled for next week is a reminder 

of action already taken. If we were to 

allow for reminders of existing 

scheduled appointments then every 

provider could meet this objective and 

measure without any patient ever 

learning new information. So we clarify 

that reminders for preventive/follow-up 

care should be for care that the patient 

is not already scheduled to receive. 

Reminders are not necessarily just to 

follow up with the reminding EP. 

Reminders for referrals or to engage in 

certain activities are also included in 

this objective and measure. 

After consideration of the public 

comments received, we are modifying 

the objective at § 495.6(j)(9)(i) to ‘‘Use 

clinically relevant information to 

identify patients who should receive 

reminders for preventive/follow-up care 

and send these patients the reminders, 

per patient preference.’’ 

Proposed EP Measure: More than 10 

percent of all unique patients who have 

had an office visit with the EP within 

the 24 months prior to the beginning of 

the EHR reporting period were sent a 

reminder, per patient preference. 

In Stage 1, the measure of this 

objective was limited to more than 20 

percent of all patients 65 years old or 

older or 5 years old or younger. Rather 

than raise the threshold for this 

measure, the HIT Policy Committee 

recommended lowering the threshold 

but extending the measure to all active 

patients. We proposed to apply the 

measure of this objective to all unique 

patients who have had an office visit 

with the EP within the 24 months prior 

to the beginning of the EHR reporting 

period. We believe this not only 

identifies the population most likely to 

consist of active patients, but also 

allows the EP flexibility to identify 

patients within that population who can 

benefit most from reminders. We 

solicited comments on the 

appropriateness of this timeframe. We 

also recognize that some EPs may not 

conduct face-to-face encounters with 

patients but still provide treatment to 

patients. These EPs could be 

unintentionally prevented from meeting 

this core objective under the measure 

requirements, so we proposed an 

exclusion for EPs who have no office 

visits in order to accommodate such 

EPs. Patient preference refers to the 

method of providing the reminder. 

Comment: Commenters expressed 

concern that even with the proposed 

revisions many patients in the 

denominator might not require a 

reminder. One example given was some 

colonoscopies are done on a schedule of 

once every ten years. Another example 

provided was specialists who see some 

patients only for one-time consults. 

Suggestions by commenters to deal with 

patients in the denominator who do not 

require reminders involve either much 

more precise measurement such as 

tracking and following up when CEHRT 

identifies the need for a patient 

reminder, to specific exclusions of 

certain visit types in the measure or to 

move the requirement to the menu set. 

Others suggested that providers who do 

not typically send reminders be sent 

granted exclusions. 

Response: We agree that not every 

active patient will require a reminder 

during the EHR reporting period, which 

is why the threshold is far below 100 

percent. We believe that a low threshold 

of 10 percent is the best way to account 

for the contextually specific reasons a 

patient might not be sent a reminder. 

We proposed an exclusion for EPs who 

would typically not send reminders, 

specifically those without office-based 

visits. This may not include all 

providers who do not typically send 

reminders, but as an exclusion must 

contain definitive criteria we believe it 

is a good exclusion. We did not receive 

in comments precise criteria for an 

alternative exclusion. 

Comment: We received many 

comments as to what constitutes an 

active patient in a practice. Many voiced 

the opinion that given the 24 month 

look back period in a typical practice, 

many patients would have moved to 

another practice. One suggestion given 

for an alternate way to count patients 

was to change the definition of ‘‘active 

patients’’ to be either three or more 

visits in 24 months or two or more visits 

in 12 months. Other commenters 

recommended that the time limitation 

be removed. 

Response: We proposed active 

patients as a method to limit the 

denominator to patients more likely to 

require a reminder. The goal is to limit 

the denominator as much as possible 

without excluding patients who should 

receive a reminder. After reviewing the 

comments, we change the look back to 

patients with at least two office visits in 

the last 24 months. We believe this 

better establishes a relationship between 

the provider and the EP. This would 

account for those specialists that do not 

have continuing relationships with their 

patients, but rather hand their care back 

to the referring provider. 

Comment: Several commenters raised 

concerns with the requirement that it be 

per patient preference. They asked for 

clarification on the definition of ‘‘per 

patient preference.’’ Specifically 

commenters asked if patient preference 

referred to whether the patient wanted 

reminders or what method of 

communication they wanted to receive 

the reminders. Second, clarification is 

requested on how providers should 

document these preferences. Third, 

there is concern that an insufficient 

number of patients will have their 

preferences recorded at the start of the 

EHR reporting period and if so, any 

method of communication should 

suffice for those patients. 

Response: We clarify that patient 

preference is the method of 

communication that patients prefer to 

receive their reminders such as (but not 

limited to) by mail, by phone or by 

secure messaging. Given the look back 

period associated with this measure, we 

agree that it is not feasible to have all 

patient preferences recorded prior to the 

start of the EHR reporting period. 

Therefore, we clarify that reminders 

must be sent using the preferred 

communication medium only when it is 

known by the provider. This is limited 

to the type of communication (phone, 

mail, secure messaging, etc.) and does 

not extend to other constraints like time 

of day. Patients may decline to provide 

their preferred communication medium 

in which case the provider may select 

the communication medium. A patient 

may also decline to receive reminders. 

We believe that this will be rare enough 

that combined with the 10 percent 

through, patients declining to receive 

reminders will not affect the ability of 

an EP to meet this measure. It is our 

expectation that providers will begin to 

collect this information and that in the 

future as the look back period catches 

up to the publication of this final rule 

it will become possible to require that 

all reminders be sent per patient 

preference. We do not specify how 

things are documented beyond the 

capabilities and standards included in 

CEHRT. 

After consideration of the public 

comments received, we are modifying 

the measure at § 495.6(j)(9)(ii) to ‘‘More 

than 10 percent of all unique patients 

who have had 2 or more office visits 

with the EP within the 24 months before 

the beginning of the EHR reporting 

period were sent a reminder, per patient 

preference when available.’’ 

We further specify that in order to 

meet this objective and measure, an EP 

must use the capabilities and standards 

of CEHRT at 45 CFR 170.314(a)(14). 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54007 

3 In 1973, the Department of Health, Education, 

and Welfare (HEW) released its report, Records, 

Computers, and the Rights of Citizens, which 

outlined a Code of Fair Information Practices that 

will create ‘‘safeguard requirements’’ for certain 

‘‘automated personal data systems’’ maintained by 

the Federal Government. This Code of Fair 

Information Practices is now commonly referred to 

as fair information practice principles (FIPPs) and 

established the framework on which much privacy 

policy will be built. There are many versions of the 

FIPPs; the principles described here are discussed 

in more detail in The Nationwide Privacy and 

Security Framework for Electronic Exchange of 

Individually Identifiable Health Information, 

December 15, 2008. http://healthit.hhs.gov/portal/

server.pt/community/healthit_hhs_gov_privacy_

security_framework/1173. 

4The FIPPs, developed in the United States 

nearly 40 years ago, are well-established and have 

been incorporated into both the privacy laws of 

many states with regard to government-held records 

and numerous international frameworks, including 

the development of the OECD’s privacy guidelines, 

the European Union Data Protection Directive, and 

the Asia-Pacific Economic Cooperation (APEC) 

Privacy Framework.http://healthit.hhs.gov/portal/

server.pt/community/healthit_hhs_gov_privacy_

security_framework/1173. 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of unique 

patients who have had two or more 

office visits with the EP in the 24 

months prior to the beginning of the 

EHR reporting period. 

• Numerator: Number of patients in 

the denominator who were sent a 

reminder per patient preference when 

available during the EHR reporting 

period. 

• Threshold: The resulting percentage 

must be more than 10 percent in order 

for an EP to meet this measure. 

• Exclusion: Any EP who has had no 

office visits in the 24 months before the 

EHR reporting period. 

Proposed EP Objective: Provide 

patients the ability to view online, 

download, and transmit their health 

information within 4 business days of 

the information being available to the 

EP. 

In the proposed rule, we stated that 

the goal of this objective was to allow 

patients easy access to their health 

information as soon as possible so that 

they can make informed decisions 

regarding their care or share their most 

recent clinical information with other 

health care providers and personal 

caregivers as they see fit. In addition, we 

noted that this objective aligns with the 

Fair Information Practice Principles 

(FIPPs),3 in affording baseline privacy 

protections to individuals.4 In 

particular, the principles include 

Individual Access (patients should be 

provided with a simple and timely 

means to access and obtain their 

individually identifiable information in 

a readable form and format). We 

indicated that this objective replaces the 

Stage 1 core objective for EPs of 

‘‘Provide patients with an electronic 

copy of their health information 

(including diagnostic test results, 

problem list, medication lists, 

medication allergies) upon request’’ and 

the Stage 1 menu objective for EPs of 

‘‘Provide patients with timely electronic 

access to their health information 

(including lab results, problem list, 

medication lists, and allergies) within 4 

business days of the information being 

available to the EP.’’ The HIT Policy 

Committee recommended making this a 

core objective for Stage 2 for EPs, and 

we agreed with their recommendation 

consistent with our policy of moving 

Stage 1 menu objectives to the core set 

for Stage 2. Consistent with the Stage 1 

requirements, we noted that the patient 

must be able to access this information 

on demand, such as through a patient 

portal or personal health record (PHR). 

However, we noted that providers 

should be aware that while meaningful 

use is limited to the capabilities of 

CEHRT to provide online access there 

may be patients who cannot access their 

EHRs electronically because of their 

disability. Additionally, other health 

information may not be accessible. 

Finally, we noted that providers who 

are covered by civil rights laws must 

provide individuals with disabilities 

equal access to information and 

appropriate auxiliary aids and services 

as provided in the applicable statutes 

and regulations. 

Comment: Some commenters 

suggested that this objective should be 

part of the menu set instead of a core 

objective for Stage 2. This would permit 

EPs who do not believe they can meet 

the measure at this time to select 

different objectives. 

Response: We do not agree that this 

objective should be part of the menu set. 

We proposed this objective as part of the 

core for EPs because it is intended to 

replace the previous Stage 1 core 

objective of ‘‘Provide patients with an 

electronic copy of their health 

information upon request’’ and the 

Stage 1 menu objective of ‘‘Provide 

patients with timely electronic access to 

their health information.’’ Although 

CEHRT will provide added capabilities 

for this objective, we do not believe the 

objective itself is sufficiently different 

from previous objectives to justify 

placing it in the menu set. Also, we 

believe that patient access to their 

electronic health information is a high 

priority for the EHR Incentive Programs 

and this objective best provides that 

access in a timely manner. 

Comment: Some commenters 

expressed the opinion that this objective 

should not be included as part of 

meaningful use and was more 

appropriately regulated under HIPAA 

and through the Office for Civil Rights. 

Response: We do not agree that this 

objective should not be included in 

meaningful use. Although we recognize 

that many issues concerning the privacy 

and security of electronic health 

information are subject to HIPAA 

requirements, we believe that 

establishing an objective to provide 

online access to health information is 

within the regulatory purview of the 

EHR Incentive Programs and consistent 

with the statutory requirements of 

meaningful use. 

Comment: Some commenters 

suggested that this objective should be 

combined with the objective to ‘‘Provide 

clinical summaries for patients after 

each office visit’’ since much of the 

information provided in these objectives 

is identical. 

Response: While it is true that there 

may be overlap between the information 

provided in the clinical summary and 

the information made available through 

this objective, we believe the clinical 

summary after an office visit serves a 

different purpose than online access to 

health information. A summary of an 

office visit provides patients and their 

families with a record of the visit and 

specific lab tests or specific follow-up 

actions and treatment related to the 

visit. While this information is certainly 

part of the patient’s overall electronic 

health record, the clinical summary 

serves to highlight information that is 

relevant to the patient’s care at that 

particular moment. Therefore, we 

decline to combine the two objectives. 

After consideration of the public 

comments, we are finalizing the 

meaningful use objective for EPs at 

§ 495.6(j)(10)(i) as proposed. 

Proposed EP Measures: We proposed 

two measures for this objective, both of 

which must be satisfied in order to meet 

the objective: 

More than 50 percent of all unique 

patients seen by the EP during the EHR 

reporting period are provided timely 

(within 4 business days after the 

information is available to the EP) 

online access to their health information 

subject to the EP’s discretion to 

withhold certain information. 

More than 10 percent of all unique 

patients seen by the EP during the EHR 

reporting period (or their authorized 

representatives) view, download or 

transmit to a third party their health 

information. 

Exclusions: Any EP who neither 

orders nor creates any of the 

information listed for inclusion as part 

of this measure may exclude both 

mstockstill on DSK4VPTVN1PROD with RULES2

54008 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

measures. Any EP that conducts 50 

percent or more of his or her patient 

encounters in a county that does not 

have 50 percent or more of its housing 

units with 4Mbps broadband 

availability according to the latest 

information available from the FCC on 

the first day of the EHR reporting period 

may exclude only the second measure. 

As we stated in the proposed rule, 

transmission can be any means of 

electronic transmission according to any 

transport standard(s) (SMTP, FTP, 

REST, SOAP, etc.). However, the 

relocation of physical electronic media 

(for example, USB, CD) does not qualify 

as transmission although the movement 

of the information from online to the 

physical electronic media will be a 

download. 

Comment: Some commenters 

suggested that the timeframe for the first 

measure should be expanded to 7 days, 

since the data required to be provided 

in order to meet the measure of this 

objective would sometimes be 

incomplete only 4 days after the 

patient’s visit. Other commenters 

suggested the timeline for the first 

measure should be shortened to 2 

business days or 24 hours. 

Response: We do not agree that the 

timeframe for the measure should be 

lengthened. In the Stage 1 menu 

objective of ‘‘Provide patients with 

timely electronic access to their health 

information,’’ we established the 

measure for providing access within 4 

business days. Also, we believe that 

most of the information required by this 

measure, except for lab tests, will be 

readily available within the specified 

time period. However, we also believe 

that 24 hours or 2 business days would 

not provide adequate time to make all 

information available online. Therefore, 

we maintain the requirement of making 

information available within 4 business 

days. 

Comment: Some commenters asked 

for clarification on whether online 

access had to be made available using 

CEHRT or if the information could be 

made available through other means 

(patient portal, PHR, etc.). 

Response: Both of the measures for 

this objective must be met using 

CEHRT. Therefore, for the purposes of 

meeting this objective, the capabilities 

provided by a patient portal, PHR, or 

any other means of online access and 

that would permit a patient or 

authorized representative to view, 

download, or transmit their personal 

health information would have to be 

certified in accordance with the 

certification requirements adopted by 

ONC. We refer readers to ONC’s 

standards and certification criteria final 

rule that is published elsewhere in this 

issue of the Federal Register. 

Comment: A commenter asked how 

long data should be made available 

online before it can be removed. In a 

related topic, another commenter asked 

which provider would be responsible 

for excluding data from sharing when 

multiple providers share CEHRT. 

Response: It is the goal of this 

objective to make available to the 

patient both current and historical 

health information. Therefore, we 

would anticipate that the data should be 

available online on an ongoing basis. 

However, an EP may withhold or 

remove information from online access 

if they believe substantial harm may 

arise from its disclosure online. In 

regard to withholding data and which 

provider should be responsible for 

making the determination when 

multiple providers share CEHRT, we 

would expect that providers sharing the 

CEHRT would make a joint 

determination regarding the information 

to be withheld. Therefore, we leave this 

decision to the providers’ discretion. 

Comment: Some commenters asked 

for clarification on how access by the 

patient is defined. 

Response: We define access as having 

been given when the patient possesses 

all of the necessary information needed 

to view, download, or transmit their 

information. This could include 

providing patients with instructions on 

how to access their health information, 

the Web site address they must visit for 

online access, a unique and registered 

username or password, instructions on 

how to create a login, or any other 

instructions, tools, or materials that 

patients need in order to view, 

download, or transmit their information. 

Comment: Some commenters 

suggested that patients under the age of 

18 should not have the same access to 

the same information to which adult 

patients have access and requested a 

separate list of required elements for 

patients under the age of 18. 

Response: An EP may decide that 

online access is not the appropriate 

forum for certain health information for 

patients under the age of 18. Within the 

confines of the laws governing guardian 

access to medical records for patients 

under the age of 18, we would defer to 

the EP’s judgment regarding which 

information should be withheld for such 

patients. In lieu of providing online 

access to patients under the age of 18, 

EPs could provide online access to 

guardians for patients under the age of 

18, in accordance with state and local 

laws, in order to meet the measure of 

this objective. Providing online access 

to guardians in accordance to state and 

local laws would be treated the same as 

access for patients, and guardians could 

then be counted in the numerator of the 

measure. We recognize that state and 

local laws may restrict the information 

that can be made available to guardians, 

and in these cases such information can 

be withheld and the patient could still 

be counted in the numerator of the 

measure. No requirement of meaningful 

use supersedes any Federal, State or 

local law regarding the privacy of a 

person’s health information. 

Comment: Some commenters 

suggested that specialists should 

transmit information to the patient’s 

primary care provider rather than 

providing online access to information 

in order to reduce the number of portals 

a patient must visit, which could cause 

confusion. 

Response: We believe that much of 

this information will be transmitted 

between providers as part of the 

summary of care record following a 

transition of care. However, we also 

believe there is value to the patient in 

having online access to this information 

for all providers they visit, including 

specialists. Therefore, we maintain this 

measure for all EPs. 

Comment: Many commenters voiced 

objections to the second measure of this 

objective and the concept of providers 

being held accountable for patient 

actions. The commenters believed that 

while providers could be held 

accountable for making information 

available online to patients, providers 

could not control whether patients 

actually accessed their information. 

Many commenters also noted that the 

potential barriers of limited internet 

access, computer access, and patient 

engagement with health IT for certain 

populations (for example, rural, elderly, 

lower income, visually impaired, nonEnglish-speaking, etc.) might make the 

measure impossible to meet for some 

providers. There were also a number of 

comments stating that metrics used to 

track views or downloads can be 

misleading and are not necessarily the 

most accurate measure of patient usage. 

Commenters suggested a number of 

possible solutions to allow providers to 

overcome these barriers, including 

eliminating the percentage threshold of 

the measure or requiring providers to 

offer and track patient access but not 

requiring them to meet a percentage 

measure in order to demonstrate 

meaningful use. However, some 

commenters believed that the measure 

was a reasonable and necessary step to 

ensure that providers had accountability 

for engagement of their patients in use 

of electronic health information and 

integration of it into clinical practice. In 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54009 

addition, commenters pointed to the 

unique role that providers can play in 

encouraging and facilitating their 

patients’ and their families’ use of 

online tools. 

Response: While we recognize that 

EPs cannot directly control whether 

patients access their health information 

online, we continue to believe that EPs 

are in a unique position to strongly 

influence the technologies patients use 

to improve their own care, including 

viewing, downloading, and transmitting 

their health information online. We 

believe that EPs’ ability to influence 

patients coupled with the low threshold 

of more than 10 percent of patients 

having viewed online, downloaded, or 

transmitted to a third party the patient’s 

health information make this measure 

achievable for all EPs. 

We recognize that certain patient 

populations face greater challenges in 

online access to health information. We 

address the potential barrier of limited 

Internet access in the comment 

regarding a broadband exclusion below. 

We address the potential barrier to 

individuals with disabilities through 

ONC’s rules requiring that EHRs meet 

web content accessibility standards. 

While we agree that excluding certain 

patient populations from this 

requirement would make the measure 

easier for EPs to achieve, we do not 

know of any reliable method to quantify 

these populations for each EP in such a 

way that we could standardize 

exclusions for each population. We also 

decline to eliminate the percentage 

threshold of this measure because we do 

not believe that a simple yes/no 

attestation for this objective is adequate 

to encourage a minimum level of patient 

usage. However, in considering the 

potential barriers faced by these patient 

populations, we agree that it would be 

appropriate to lower the proposed 

threshold of this measure to more than 

5 percent of unique patients who view 

online, download, or transmit to a third 

party the patient’s health information. 

In addition, we are concerned that 

blanket exclusions for certain 

disadvantaged populations could serve 

to extend existing disparities in 

electronic access to health information 

and violate civil rights laws. All entities 

receiving funds under this program are 

subject to civil rights laws. For more 

information about these laws and their 

requirements (see http://www.hhs.gov/ 

ocr/civilrights/index.html). We believe 

that this lower threshold, combined 

with the broadband exclusion detailed 

in the response that follow, will allow 

all EPs to meet the measure of this 

objective. 

Comment: Some commenters 

suggested an alternate definition of the 

second measure based on the number of 

patients seen within the last 2 years that 

access their health information online. 

Response: We believe that the current 

numerator and denominator for this 

measure encourage the active online 

access by patients of their health 

information. We further believe that 

broadening the time period of this 

measure to patients seen within the last 

2 years does not encourage both EPs and 

current patients to use online access to 

health information in the active 

management of their care, which is one 

of the goals of the EHR Incentive 

Programs. Therefore, we decline to 

adopt this suggested alternate 

definition. 

Comment: Some commenters asked 

for clarification on how view is defined. 

Response: We define view as the 

patient (or authorized representative) 

accessing their health information 

online. 

Comment: Some commenters noted 

that the potential financial burden of 

implementing an online patient portal 

to provide patients online access to 

health information. These commenters 

noted the added time burden for staff in 

handling the additional patient use of 

online resources, which may increase 

costs through the hiring of additional 

staff, as well as the need to modify their 

existing workflow to accommodate 

additional online messages from 

patients. Some commenters also 

believed that there would be an 

additional cost for sharing content 

before standards exist for content types 

and formats. 

Response: We do not believe that 

implementing online access for patients 

imposes a significant burden on 

providers. While we note that in some 

scenarios it may be possible for an EP 

to receive reimbursement from private 

insurance payers for online messaging, 

we acknowledge that EPs are generally 

not reimbursed for time spent 

responding to electronic messaging. 

However, it is also true that EPs are 

generally not reimbursed for other 

widely used methods of communication 

with patients (for example, telephone). 

As we noted in the proposed rule, many 

providers have seen a reduction in time 

responding to inquires and less time 

spent on the phone through the use of 

health IT, including online messages 

from patients. We expect the same will 

be true for online access to health 

information by reducing continuous 

requests for health records, test results, 

and other pertinent patient information. 

Finally, we believe that the standards 

established for this objective by ONC 

will serve as a content standard that will 

allow this information to be more easily 

transmitted and uploaded to another 

certified EHR, thereby reducing 

additional costs. 

Comment: Some commenters noted 

that patient engagement could occur 

effectively with or without online 

access, and patients should be 

encouraged to use any method (for 

example, telephone, internet, traditional 

mail) that suits them. These commenters 

noted that engagement offline reduces 

both the need and value for engagement 

online. 

Response: We agree that patient 

engagement can occur effectively 

through a variety of media, and we also 

believe that electronic access to health 

information can be an important 

component of patient engagement. We 

do not believe that offline engagement 

reduces the need for online access, as 

patients may opt to access information 

in a variety of ways. Because of the 

variety of ways that patients/families 

may access information, we keep the 

threshold for this measure low. We also 

note that online access to health 

information can enhance offline 

engagement—for example, patients 

could download information from an 

office visit with their primary care 

provider to bring with them for a 

consult with a specialist—which is one 

of the primary goals of the EHR 

Incentive Programs. 

Comment: Some commenters 

expressed concern that vendors would 

not be able to make these capabilities 

available as part of CEHRT in time for 

the beginning of Stage 2. 

Response: Many CEHRT vendors 

already make patient portals available 

that would meet the certification criteria 

and standards required for this measure. 

In fact, many vendors have already 

incorporated these capabilities into their 

CEHRT products in order to meet the 

measure of the Stage 1 objective to 

‘‘Provide patients with timely electronic 

access to their health information.’’ 

Although the Stage 2 measure requires 

some additional capabilities, we believe 

vendors will be able to make these 

capabilities available in time for the 

beginning of Stage 2. 

Comment: Some commenters 

requested clarification on the exclusion 

regarding an EP ‘‘who neither orders nor 

creates any of the information listed for 

inclusion as part of this measure may 

exclude both measures.’’ Because the 

list of required elements for this 

measure includes the patient’s name, 

provider’s name, and office contact 

information, these commenters 

suggested that no EP could qualify for 

this exclusion. 

mstockstill on DSK4VPTVN1PROD with RULES2

54010 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

Response: We amend the wording of 

the exclusion to accommodate providers 

who do not order or create any of the 

information listed, except for patient 

name, provider name, and office contact 

information. 

Comment: Some commenters 

suggested that basing an exclusion on 

the broadband data available from the 

FCC Web site (www.broadband.gov) was 

suspect since the data originates from 

vendors. 

Response: The broadband data made 

available from the FCC was collected 

from over 3,400 broadband providers 

nationwide. This data was then subject 

to many different types of analysis and 

verification methods, from drive testing 

wireless broadband service across their 

highways to meeting with community 

leaders to receive feedback. 

Representatives met with broadband 

providers, large and small, to confirm 

data, or suggest changes to service areas, 

and also went into the field looking for 

infrastructure to validate service 

offerings in areas where more 

information was needed. Therefore, we 

believe the data is appropriate for the 

exclusion to this measure. We note that 

since publication of our proposed rule 

the Web site has changed to 

www.broadbandmap.gov and the speed 

used has changed from 4Mbps to 

3Mbps. We are updating our exclusion 

to reflect these changes. 

Comment: Some commenters believe 

that broadband exclusions should be 

based on the patients’ locations instead 

of the providers, since county-level data 

may not be granular enough to capture 

all areas of low broadband availability 

within a particular region. 

Response: Although we agree that a 

broadband exclusion based primarily on 

the individual locations of each patient 

seen would be more accurate, we do not 

believe that there is any method of 

making this determination for every 

patient without placing an undue 

burden on the provider. We continue to 

believe that limited broadband 

availability in the EP’s immediate 

practice area, coupled with the low 

threshold of this measure, adequately 

serves as an acceptable proxy for 

determining areas where online access 

can present a challenge for patients. 

Therefore, we retain the broadband 

exclusion as proposed. 

Comment: Some commenters 

requested a clarification of the required 

element of ‘‘Any additional known care 

team members beyond the referring or 

transitioning provider and the receiving 

provider.’’ 

Response: With this element we mean 

for providers to indicate the names and 

contact information for any other health 

care professionals known to the EP. This 

could include referring providers, 

receiving providers, or any other 

provider inside or outside the EP’s 

practice that provides care to the 

patient. We are amending the language 

for this required element to ‘‘Any 

known care team members.’’ 

Comment: Some commenters 

suggested that growth charts should not 

be included for either download or 

transmission, since these charts are 

simply visualizations of the height and 

weight data elements. 

Response: We believe that growth 

charts can be a useful tool for both 

patients and providers, especially in 

instances where a patient may elect to 

download or transmit their health 

information to another provider. 

Therefore, we require them to be 

included to meet the measure of this 

objective. 

Comment: One commenter suggested 

that images should not be included in 

the list of required elements to be 

provided to patients online. They cited 

specific difficulties in image viewing 

online, as well as concerns over file 

size. 

Response: We note the commenter’s 

concerns and further note that images 

are not among the required elements to 

meet the measure of this objective. 

After consideration of the public 

comments, we finalize the first 

meaningful use measure for EPs as 

proposed at § 495.6(j)(10)(ii)(A). We 

finalize the second meaningful use 

measure for EPs as ‘‘More than 5 percent 

of all unique patients seen by the EP 

during the EHR reporting period (or 

their authorized representatives) view, 

download or transmit to a third party 

their health information’’ at 

§ 495.6(j)(10)(ii)(B). We finalize the 

following exclusions for EPs at 

§ 495.6(j)(10)(iii): ‘‘Any EP who neither 

orders nor creates any of the 

information listed for inclusion as part 

of both measures, except for ‘‘Patient 

name’’ and ‘‘Provider’s name and office 

contact information,’’ may exclude both 

measures;’’ ‘‘Any EP that conducts 50 

percent or more of his or her patient 

encounters in a county that does not 

have 50 percent or more of its housing 

units with 3Mbps broadband 

availability according to the latest 

information available from the FCC on 

the first day of the EHR reporting period 

may exclude only the second measure’’. 

We further specify that in order to 

meet this objective and measure, an EP 

must use the capabilities and standards 

of CEHRT at 45 CFR 170.314(e)(1). 

To calculate the percentage of the first 

measure for providing patient with 

timely online access to health 

information, CMS and ONC have 

worked together to define the following 

for this objective: 

• Denominator: Number of unique 

patients seen by the EP during the EHR 

reporting period. 

• Numerator: The number of patients 

in the denominator who have timely 

(within 4 business days after the 

information is available to the EP) 

online access to their health 

information. 

• Threshold: The resulting percentage 

must be more than 50 percent in order 

for an EP to meet this measure. 

For the second measure for reporting 

on the number of unique patients seen 

by the EP during the EHR reporting 

period (or their authorized 

representatives) who view, download or 

transmit health information, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of unique 

patients seen by the EP during the EHR 

reporting period. 

• Numerator: The number of unique 

patients (or their authorized 

representatives) in the denominator who 

have viewed online, downloaded, or 

transmitted to a third party the patient’s 

health information. 

• Threshold: The resulting percentage 

must be more than 5 percent in order for 

an EP to meet this measure. 

• Exclusions: Any EP who neither 

orders nor creates any of the 

information listed for inclusion as part 

of both measures, except for ‘‘Patient 

name’’ and ‘‘Provider’s name and office 

contact information,’’ may exclude both 

measures. Any EP that conducts 50 

percent or more of his or her patient 

encounters in a county that does not 

have 50 percent or more of its housing 

units with 3Mbps broadband 

availability according to the latest 

information available from the FCC on 

the first day of the EHR reporting period 

may exclude only the second measure. 

In order to meet this objective, the 

following information must be made 

available to patients electronically 

within 4 business days of the 

information being made available to the 

EP: 

• Patient name. 

• Provider’s name and office contact 

information. 

• Current and past problem list. 

• Procedures. 

• Laboratory test results. 

• Current medication list and 

medication history. 

• Current medication allergy list and 

medication allergy history. 

• Vital signs (height, weight, blood 

pressure, BMI, growth charts). 

• Smoking status. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54011 

• Demographic information 

(preferred language, sex, race, ethnicity, 

date of birth). 

• Care plan field(s), including goals 

and instructions, and 

• Any known care team members 

including the primary care provider 

(PCP) of record. 

As we stated in the proposed rule, 

this is not intended to limit the 

information made available by the EP. 

An EP can make available additional 

information and still align with the 

objective. In circumstances where there 

is no information available to populate 

one or more of the fields previously 

listed, either because the EP can be 

excluded from recording such 

information (for example, vital signs) or 

because there is no information to 

record (for example, no medication 

allergies or laboratory tests), the EP may 

have an indication that the information 

is not available and still meet the 

objective and its associated measure. 

Please note that while some of the 

information made available through this 

measure is similar to the information 

made available in the summary of care 

document that must be provided 

following transitions of care or referrals, 

the list of information above is specific 

to the view online, download, and 

transmit objective. Patients and 

providers have different information 

needs and contexts, so CMS has 

established separate required fields for 

each of these objectives. 

Proposed Objective: Use clinically 

relevant information from Certified EHR 

Technology to identify patient-specific 

education resources and provide those 

resources to the patient. 

In the proposed rule, we explained 

that providing clinically relevant 

education resources to patients is a 

priority for the meaningful use of 

CEHRT. Based on our experience with 

this objective in Stage 1, we are 

clarifying that while CEHRT must be 

used to identify patient-specific 

education resources, these resources or 

materials do not have to be stored 

within or generated by the CEHRT. We 

are aware that there are many electronic 

resources available for patient education 

materials, such as through the National 

Library of Medicine, that can be queried 

via CEHRT (that is, specific patient 

characteristics are linked to specific 

consumer health content). The EP or 

hospital should utilize CEHRT in a 

manner where the technology suggests 

patient-specific educational resources 

based on the information stored in the 

CEHRT. Certified EHR technology is 

certified to use the patient’s problem 

list, medication list, or laboratory test 

results to identify the patient-specific 

educational resources. The EP or 

hospital may use these elements or 

additional elements within CEHRT to 

identify educational resources specific 

to patients’ needs. The EP or hospital 

can then provide these educational 

resources to patients in a useful format 

for the patient (such as, electronic copy, 

printed copy, electronic link to source 

materials, through a patient portal or 

PHR). 

In the Stage 1 final rule (75 FR 44359), 

we included the phrase ‘‘if appropriate’’ 

in the objective so that the EP or the 

authorized provider in the hospital 

could determine whether the education 

resource was useful and relevant to a 

specific patient. Consistent with the 

recommendations of the HIT Policy 

Committee, we proposed to remove the 

phrase ‘‘if appropriate’’ from the 

objective for Stage 2 because we do not 

believe that any EP or hospital will have 

difficulty identifying appropriate 

patient-specific education resources for 

the low percentage of patients required 

by the measure of this objective. 

We also recognized that providing 

education materials at literacy levels 

and cultural competency levels 

appropriate to patients is an important 

part of providing patient-specific 

education. However, we continue to 

believe that there is not currently 

widespread availability of such 

materials and that such materials could 

be difficult for EPs and hospitals to 

identify for their patients. 

Comment: Many commenters sought 

clarification on the meaning of the term 

‘‘identified by CEHRT.’’ They 

questioned how the CEHRT would 

identify resources and whether the 

education resources had to be stored in 

the CEHRT or if it could contain links 

to the materials. 

Response: We clarified in the 

proposed rule (77 FR 13720) that while 

CEHRT must be used to identify patientspecific education resources, these 

resources or materials do not have to be 

stored within or generated by the 

Certified EHR Technology. We refer 

readers to ONC’s standards and 

certification criteria final rule that is 

published elsewhere in this issue of the 

Federal Register which describes the 

capabilities and standards that CEHRT 

must include. For patient-specific 

education materials, this includes a 

general functional capability to identify 

educational materials as well as a 

capability to do so using the HL7 

Context-aware Information Retrieval 

‘‘Infobutton’’ standard. This measure 

requires that an EP or hospital use the 

capabilities CEHRT includes to identify 

patient education materials. To clarify, 

although CEHRT will include the ability 

to identify education materials using the 

HL7 Infobutton standard, such 

capability alone does not need to be 

used in order to be counted in the 

numerator (that is, the general capability 

to identify education materials also 

counts towards the numerator). 

After reviewing the public comments, 

we finalize the objective for EPs at 

§ 495.6(j)(12)(i) and for eligible hospitals 

and CAHs at § 495.6(l)(9)(i) as proposed. 

Proposed EP Measure: Patient-specific 

education resources identified by 

Certified EHR Technology are provided 

to patients for more than 10 percent of 

all office visits by the EP. 

In the proposed rule, we noted that 

the Stage 1 measure for this objective for 

EPs was ‘‘More than 10 percent of all 

unique patients seen by the EP are 

provided patient-specific education 

resources.’’ Because we proposed this as 

a core objective for Stage 2, we proposed 

to modify the measure for EPs to 

‘‘Patient-specific education resources 

identified by CEHRT are provided to 

patients for more than 10 percent of all 

office visits by the EP.’’ We recognized 

that some EPs may not conduct face-toface encounters with patients but still 

provide treatment to patients. These EPs 

could be prevented from meeting this 

core objective under the previous 

measure requirements, so we proposed 

to alter the measure to account for office 

visits rather than unique patients seen 

by the EP. We also proposed an 

exclusion for EPs who have no office 

visits in order to accommodate such 

EPs. 

The resources will have to be those 

identified by CEHRT. If resources are 

not identified by CEHRT and provided 

to the patient then it will not count in 

the numerator. We do not intend 

through this requirement to limit the 

education resources provided to patient 

to only those identified by CEHRT. We 

proposed the threshold at only 10 

percent for this reason. We believe that 

the 10 percent threshold both ensures 

that providers are using CEHRT to 

identify patient-specific education 

resources and is low enough to not 

infringe on the provider’s freedom to 

choose education resources and to 

which patients these resources will be 

provided. The education resources will 

need to be provided prior to the 

calculation and subsequent attestation 

to meaningful use. 

Comment: Many commenters 

expressed concerns about the 

availability of resources that would be 

available at the appropriate literacy 

level for their patient populations. Some 

stated that there is a dearth of lowliteracy materials available as most 

education sites are geared toward 

mstockstill on DSK4VPTVN1PROD with RULES2

54012 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

college-educated patients; others stated 

that most materials are designed to be 

appropriate for a broad spectrum of 

literacy levels. Some commenters 

expressed concerns about the lack of 

resources available for non-English 

speaking patients. Yet other commenters 

were unclear as to what appropriate 

sources of patient-specific education 

would be. Some commenters expressed 

concerns that another alert within the 

system may create physician fatigue. 

Response: We understand the 

commenters concerns that the 

educational materials identified by the 

CEHRT may not be appropriate for 

certain patients. To accommodate these 

concerns, we are maintaining the 

threshold for this measure at 10 percent. 

As we stated in our proposed rule and 

in the Stage 1 Final Rule, we account for 

these concerns by maintaining a low 

threshold for this objective. 

Comment: Some commenters 

expressed concerns that the CEHRT, not 

the provider, would ‘‘choose’’ which 

educational resources would be 

provided to the patient. 

Response: We cannot define the scope 

of practice and/or appropriate 

educational resources to be shared with 

each individual patient and will 

continue to rely on provider 

determinations based on individual 

patient circumstances. 

Comment: Many commenters were 

concerned that the denominator for the 

EP measure included the number of 

office visits by the EP during the EHR 

reporting period. Commenters agreed 

with the rationale that EPs might not 

have the opportunity to provide 

educational materials to a patient if the 

patient has not had an office visit with 

the EP, however, commenters also 

stated that if an EP has a series of office 

visits with a patient, it might not be 

appropriate to provide education at each 

visit (for example, a patient with heart 

disease or high blood pressure that 

would see the EP multiple times during 

the EHR reporting period). To avoid the 

potential for presenting redundant 

information to patients, commenters 

suggested that the denominator be based 

on unique patients with office visits. 

This is consistent with the denominator 

for eligible hospitals, as that 

denominator is based on unique 

patients admitted. Additionally, 

commenters noted that counting unique 

patients is more appropriate to account 

for patient-specific education resources 

that are not provided in the context of 

an office visit, such as reference 

materials available from a portal or PHR 

about a patient’s medications, 

conditions, or lab results. 

Response: We agree with commenters 

in that counting unique patients with 

office visits during the EHR reporting 

period for EPs, rather than office visits, 

is a more appropriate denominator for 

this measure. A patient with a chronic 

disease, such as diabetes or heart 

disease, may have multiple office visits 

with an EP during the EHR reporting 

period. While providing educational 

resources for these patients is important, 

presenting the same materials each 

office visit may prove to be redundant. 

We encourage EPs to refer educational 

resources to their patients with multiple 

visits during the EHR reporting period 

at their discretion. 

Additionally, we do maintain that EPs 

with no office visits during the EHR 

reporting period can be excluded from 

this measure. Therefore, we are 

finalizing the denominator for this 

measure as the ‘‘Number of unique 

patients with office visits seen by the EP 

during the EHR reporting period.’’ 

Comment: Most commenters agreed 

that 10 percent was a reasonable 

threshold for this measure as it was 

proposed. 

Response: We agree with commenters 

and are finalizing 10 percent as the 

threshold for this measure. It will 

remain unchanged from Stage 1. 

After reviewing the public comments, 

we are finalizing the measure for EPs at 

§ 495.6(j)(12)(ii) as ‘‘Patient-specific 

education resources identified by 

CEHRT are provided to patients for 

more than 10 percent of all unique 

patients with office visits seen by the EP 

during the EHR reporting period.’’ 

We further specify that in order to 

meet this objective and measure, an EP 

must use the capabilities and standards 

of CEHRT at 45 CFR 170.314(a)(15). 

To calculate the percentage for EPs, 

CMS and ONC have worked together to 

define the following for this objective: 

• Denominator: Number of unique 

patients with office visits seen by the EP 

during the EHR reporting period. 

• Numerator: Number of patients in 

the denominator who were provided 

patient-specific education resources 

identified by the Certified EHR 

Technology. 

• Threshold: The resulting percentage 

must be more than 10 percent in order 

for an EP to meet this measure. 

• Exclusion: Any EP who has no 

office visits during the EHR reporting 

period. 

Proposed Eligible Hospital/CAH 

Measure: More than 10 percent of all 

unique patients admitted to the eligible 

hospital’s or CAH’s inpatient or 

emergency departments (POS 21 or 23) 

are provided patient-specific education 

resources identified by Certified EHR 

Technology. 

After consideration of public 

comments, we are finalizing the 

measure for eligible hospitals and CAHs 

at § 495.6(l)(9)(ii) as proposed. 

We further specify that in order to 

meet this objective and measure, an 

eligible hospital or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(a)(15). 

To calculate the percentage for 

hospitals, CMS and ONC have worked 

together to define the following for this 

objective: 

• Denominator: Number of unique 

patients admitted to the eligible 

hospital’s or CAH’s inpatient or 

emergency departments (POS 21 or 23) 

during the EHR reporting period. 

• Numerator: Number of patients in 

the denominator who are subsequently 

provided patient-specific education 

resources identified by CEHRT. 

• Threshold: The resulting percentage 

must be more than 10 percent in order 

for an eligible hospital or CAH to meet 

this measure. 

Proposed Objective: The EP, eligible 

hospital or CAH who receives a patient 

from another setting of care or provider 

of care or believes an encounter is 

relevant should perform medication 

reconciliation. 

In the proposed rule we outlined the 

following benefits of this objective. 

Medication reconciliation allows 

providers to confirm that the 

information they have on the patient’s 

medication is accurate. This not only 

assists the provider in their direct 

patient care, it also improves the 

accuracy of information they provide to 

others through health information 

exchange. 

In the proposed rule, we noted that 

that when conducting medication 

reconciliation during a transition of 

care, the EP, eligible hospital or CAH 

that receives the patient into their care 

should conduct the medication 

reconciliation. We reiterated that the 

measure of this objective does not 

dictate what information must be 

included in medication reconciliation. 

Information included in the process of 

medication reconciliation is 

appropriately determined by the 

provider and patient. In the proposed 

rule we defined medication 

reconciliation as the process of 

identifying the most accurate list of all 

medications that the patient is taking, 

including name, dosage, frequency, and 

route, by comparing the medical record 

to an external list of medications 

obtained from a patient, hospital or 

other provider. We proposed that the 

electronic exchange of information is 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54013 

not a requirement for medication 

reconciliation. 

Comment: Commenters requested that 

the definition of medication 

reconciliation should specifically 

mention over-the-counter medications, 

vitamins, herbal or other alternative care 

medications in the definition. 

Response: We believe our term 

medications is expansive and not 

limiting. We in no way limit what any 

provider chooses to include or not 

include in their conduct of a medication 

reconciliation. As we are focused on the 

use of CEHRT to assist in medication 

reconciliation it is not our intent to 

develop a definitive definition of what 

medication reconciliation is. 

Comment: Commenters stated that the 

objective is so reliant on health 

information exchange that it should not 

be moved to core until health 

information exchange capability 

increases. 

Response: Robust health information 

exchange is certainly of great assistance 

to medication reconciliation. However, 

it is not required for medication 

reconciliation. Nor is electronic health 

information exchange the only way 

EHRs can assist with medication 

reconciliation. So while we believe that 

medication reconciliation will become 

easier as health information exchange 

capability increases, it is not a 

prerequisite to performing medication 

reconciliation. 

After consideration of the comments 

received, we are finalizing this objective 

as proposed for EPs at § 495.6(j)(13)(i) 

and for eligible hospitals and CAHs at 

§ 495.6(l)(10)(i). 

Proposed Measure: The EP, eligible 

hospital or CAH performs medication 

reconciliation for more than 65 percent 

of transitions of care in which the 

patient is transitioned into the care of 

the EP or admitted to the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23). 

In the proposed rule, we stated that 

although the HITPC recommended 

maintaining this threshold at 50 percent 

we believed that due to this measure’s 

role in information exchange that we 

seek to promote through meaningful use 

a higher measure was appropriate. 

Based on the performance of providers 

in Stage 1, we proposed to raise the 

measure to 65 percent. 

Comment: If as stated in the proposed 

rule ‘‘the majority chose to defer this 

measure in Stage 1,’’ commenters 

asserted that this is insufficient 

information to justify raising the 

threshold to 65 percent and move the 

objective to core. Other commenters 

assert that any measure that moves from 

menu to core should maintain its Stage 

1 threshold regardless of the particular 

measure’s rate of deferral. 

Response: After considering the 

arguments for lowering the threshold to 

50 percent and the lack of robust data 

in support of the proposed threshold, 

we do lower the threshold to 50 percent. 

For this measure in particular, we agree 

that since most providers chose to defer 

this measure in Stage 1 the information 

available on performance from Stage 1 

meaningful EHR users is not as robust 

as for other objectives and measures. We 

do not agree with the comment that all 

objectives that move from menu to core 

should maintain the same threshold. We 

believe such a blanket policy would be 

arbitrary and not properly account for 

the information available for each 

objective and measure. For example, if 

most Stage 1 meaningful EHR users had 

reported on this measure, there would 

be a robust data set of performance on 

which to judge a threshold. A blanket 

policy would ignore such information. 

Comment: The denominator of 

transitions of care during the EHR 

reporting period for which the provider 

is the receiving part of the transition is 

imprecise and therefore difficult to 

determine, especially when neither the 

transitioning provider or patient notifies 

the provider of the transition. 

Response: We addressed this 

comment earlier in this section in our 

discussion of meaningful use 

denominators and provided a minimum 

set of specific actions that would 

indicate a transition of care has 

occurred. 

Comment: While the objective speaks 

to relevant encounters, these are not 

included in the measure. This makes 

measurement difficult for those 

providers that conduct medication 

reconciliation at more than just 

transitions of care. If providers were 

allowed to include these encounters in 

the measure, measurement would both 

be easier and more representative of the 

actual use of CEHRT by the provider. 

Response: We continue to believe that 

what is a relevant encounter is to 

variable to be included in the measure 

for all providers. However, a provider 

who institutes a policy for medication 

reconciliation at encounters 

encompassing more than just the 

minimum actions defined by the 

transitions of care denominator can 

include those encounters in their 

denominator and if medication 

reconciliation is conducted at the 

encounter in the numerator as well. 

After consideration of the comments, 

we are modifying the threshold of the 

measure for EPs at § 495.6(j)(13)(ii) and 

for eligible hospitals and CAHs at 

§ 495.6(l)(10)(ii). The EP, eligible 

hospital or CAH performs medication 

reconciliation for more than 50 percent 

of transitions of care in which the 

patient is transitioned into the care of 

the EP or admitted to the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23). 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(b)(4). 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of transitions 

of care during the EHR reporting period 

for which the EP or eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) was the 

receiving party of the transition. 

• Numerator: The number of 

transitions of care in the denominator 

where medication reconciliation was 

performed. 

• Threshold: The resulting percentage 

must be more than 50 percent in order 

for an EP, eligible hospital or CAH to 

meet this measure. 

• Exclusion: Any EP who was not the 

recipient of any transitions of care 

during the EHR reporting period. 

Proposed Objective: The EP, eligible 

hospital or CAH who transitions their 

patient to another setting of care or 

provider of care or refers their patient to 

another provider of care provides a 

summary care record for each transition 

of care or referral. 

In the proposed rule, we outlined the 

following benefits of this objective. By 

assuring lines of communication 

between providers caring for the same 

patient, all of the providers of care can 

operate with better information and 

more effectively coordinate the care 

they provide. Electronic health records, 

especially when linked directly or 

through health information exchanges, 

reduce the burden of such 

communication. The purpose of this 

objective is to ensure a summary of care 

record is provided to the receiving 

provider when a patient is transitioning 

to a new provider or has been referred 

to another provider while remaining 

under the care of the referring provider. 

In the proposed rule, we proposed to 

eliminate the Stage 1 objective for the 

exchange of key clinical information for 

Stage 2 and instead include such 

information as part of the summary of 

care when it is a part of the patient’s 

electronic record. We also proposed to 

incorporate two separate Stage 2 

recommendations from the HIT Policy 

Committee as required fields in the 

summary of care record— 

mstockstill on DSK4VPTVN1PROD with RULES2

54014 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

• Record care plan fields, including 

goals and instructions, for at least 10 

percent of transitions of care; and 

• Record team member, including 

primary care practitioner, for at least 10 

percent of patients. 

ONC also proposed in their standards 

and certification criteria rule (77 FR 

13848 to include these as standard 

fields required to populate the summary 

of care document so CEHRT will be able 

to include this information. We 

provided a description of a ‘‘care plan’’ 

as well as the minimum components it 

must include for purposes of 

meaningful use, although we recognized 

that the actual content would be 

dependent on the clinical context. We 

asked for comments on both our 

description of a care plan and whether 

a description is necessary for purpose of 

meaningful use. 

We proposed certain elements that are 

listed in the proposed rule (77 FR 

13722) to be included in the summary 

care document. In circumstances where 

there is no information available on an 

element, either because the EP, eligible 

hospital or CAH can be excluded from 

recording such information or because 

there is no information to record, the 

EP, eligible hospital or CAH may leave 

the field(s) blank and still meet the 

objective and its associated measure. 

In addition, we proposed that all 

summary of care documents used to 

meet this objective must include the 

following: 

• An up-to-date problem list of 

current and active diagnoses. 

• An active medication list, and 

• An active medication allergy list. 

We proposed that all summary of care 

documents must contain the most recent 

and up-to-date information on these 

three elements to count in the 

numerator. We proposed to define 

problem list as a list of current and 

active diagnoses. We solicited comment 

on whether the problem list should be 

extended to include, ‘‘when applicable, 

functional and cognitive limitations’’ or 

whether a separate list should be 

included for functional and cognitive 

limitations. We proposed to define an 

up-to-date problem list as a list 

populated with the most recent 

diagnoses known by the EP or hospital. 

We proposed to define active 

medication list as a list of medications 

that a given patient is currently taking. 

We proposed to define active 

medication allergy list as a list of 

medications to which a given patient 

has known allergies. We proposed to 

define allergy as an exaggerated immune 

response or reaction to substances that 

are generally not harmful. In the event 

that there are no current or active 

diagnoses for a patient, the patient is not 

currently taking any medications, or the 

patient has no known medication 

allergies, confirmation of no problems, 

no medications, or no medication 

allergies would satisfy the measure of 

this objective. Note that the inclusion 

and verification of these elements in the 

summary of care record replaces the 

Stage 1 objectives for ‘‘Maintain an upto-date problem list,’’ ‘‘Maintain active 

medication list,’’ and ‘‘Maintain active 

medication allergy list.’’ 

Comment: Commenters suggested that 

the required data for each type of 

referral and transitions varies and that 

rather than creating a list of elements, 

the provider should decide what is 

needed. 

Response: While we agree that 

tailoring the summary of care document 

for each referral and transition of care is 

desirable, we disagree that this means a 

list of basic elements that should be in 

each summary of care documents is not 

appropriate. We note that most 

organizations that try and tackle the 

issue of summary of care documents 

have required fields, core sets or other 

nomenclature for elements that they 

believe should be in all summary of care 

documents. For example, the CDA 

architecture used as the standard for the 

summary of care document contains 

required and optional fields. The 

American College of Physicians in their 

Neighborhood Model uses a core data 

set. None of these organizations intend 

for their list of elements to be limiting 

and nor do we intend our list to be 

limiting, but rather serve as a minimum. 

In our proposed rule we went further 

and said that if the provider does not 

have the information available to 

populate one or more of the fields listed, 

either because they can be excluded 

from recording such information (for 

example, vital signs) or because there is 

no information to record (for example, 

laboratory tests), the provider may leave 

the field(s) blank. The only exception to 

this is the problem list, medication list, 

and medication allergy list. Therefore, 

we are including a list of elements in 

this final rule. 

Comment: Commenters stated that 

their understanding is that if any of the 

fields specifically for problem list, 

medication list, or allergy list is blank 

(meaning no entry of problems, 

medications or allergies nor an 

indication that it is known by the 

provider that the patient has no 

problems, medication or allergies), the 

EP or hospital will not meet the 

measure, but that if any other 

information is blank, the EP or hospital 

will still meet the measure. Please 

clarify whether this is a correct 

understanding of the proposal. 

Response: This understanding of our 

proposed rule is generally correct. The 

problem list, medication list and 

medication allergy list must also either 

contain problems, medications and 

medication allergy or a specific notation 

that the patient has none. Leaving the 

field entirely blank with no entry 

whatsoever would not meet the 

measure. However, in cases where the 

provider does not have the information 

available to populate one or more of the 

other fields listed, either because they 

can be excluded from recording such 

information (for example, vital signs) or 

because there is no information to 

record (for example, laboratory tests), 

the provider may leave the field(s) 

blank. Note this does not allow a 

provider to disable a listed field from 

being generated by the CEHRT, but 

rather allows for when the CEHRT does 

not contain information on which to 

generate an entry for the field. 

Comment: Some commenters 

suggested the substitution of past 

medical history for historical problem 

list in the list of required elements, 

since past medical history could 

provide additional information valuable 

to patient care. 

Response: CMS’ Evaluation and 

Management Services Guide defines a 

past medical history as the patient’s past 

‘‘experiences with illnesses, operations, 

injuries and treatments’’ (see http:// 

www.cms.gov/Outreach-and-Education/ 

Medicare-Learning-Network-MLN/ 

MLNProducts/downloads/ 

eval_mgmt_serv_guide-ICN006764.pdf, 

p. 11). In our proposed rule, we referred 

to ‘‘current and historical problem list’’ 

as this is more concrete and standards 

based than the definition for past 

medical history. We believe the concept 

of past medical history is inclusive of 

current and historical problem list. We 

understand that providers are more 

familiar with the term past medical 

history and will evaluate expanding 

historical problem list to past medical 

history for Stage 3. However, for Stage 

2, we are finalizing current and 

historical problem list. For summary of 

care documents at transitions of care we 

encourage providers to send a list of 

items that he or she believes to be 

pertinent and relevant to the patient’s 

care, rather than a list of all problems, 

whether they are active or resolved, that 

have ever populated the problem list. 

While a current problem list should 

always be included, the provider can 

use his or her judgment in deciding 

which items historically present on the 

problem list, PMHx list (if it exists in 

CEHRT), or surgical history list are 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54015 

included given the clinical 

circumstances. 

Comment: Commenters stated that it 

is too burdensome to determine whether 

the problem list, medication list and 

medication allergy list are included in 

each summary of care document. 

Response: We disagree that this is too 

burdensome. We note that in Stage 1 

measuring the completeness of the 

problem list, medication list and 

medication allergy list is already a 

requirement. Summary of care 

documents are generated by the CEHRT 

based on the information available to it. 

Therefore, there are only two causes of 

error that would have to be discovered 

to make the determination of whether 

the problem list, medication list and 

medication allergy list are included. The 

problem list, medication list and 

medication allergy list do not contain 

information for a given patient and/or 

there is an error in the generation of the 

summary of care document. This 

discovery constitutes the burden of this 

measure. We have already noted that the 

ability to know whether the lists contain 

information is already a Stage 1 

measure. The second issue is prevalent 

in nearly every meaningful use measure 

that requires CEHRT to generate a 

measurement so that burden is already 

integral to meaningful use. 

Comment: Commenters stated that the 

different descriptions of problem list 

throughout the proposed rule create 

confusion. The four terms used are ‘‘an 

up-to-date problem list of current and 

active diagnoses’’, ‘‘problem list’’, 

‘‘Current problem list and any updates 

to it’’ and ‘‘problem list maintained by 

the hospital on the patient’’. CMS 

should use this term uniformly. 

Furthermore, the limitation of the 

problem list to only current and active 

diagnoses is inconsistent with how 

problem lists are used and historical 

problems should also be included. 

Response: We only proposed one 

definition of the base term ‘‘problem 

list’’, which is a list of current and 

active diagnoses. We then use 

descriptors to tailor the term to the 

objective in which it is being utilized. 

For example, ‘‘up-to-date’’ means that 

the problem list in the CEHRT is 

populated with the most recent 

diagnoses known by the EP or hospital. 

The description used for office visit 

summary ‘‘Current problem list and any 

updates to it’’ was intended to separate 

problems that were known before the 

visit and those that were determined 

during the visit. We agree that our 

limitation of the ‘‘problem list’’ to just 

current and active diagnoses is 

unnecessarily limiting. The C–CDA, 

which is the standard adopted for EHR 

technology certification, for summary of 

care documents states that ‘‘at a 

minimum, all pertinent current and 

historical problems should be listed’’. 

We revise our definition of ‘‘problem 

list’’ to include historical problems. 

This is a minimum. We do not limit the 

provider to just including diagnoses on 

the problem list. We agree that there 

should be just one definition of the base 

term ‘‘problem list’’; however, we 

disagree that the same list is appropriate 

for every case especially with the 

addition of the historical problems. 

Some objectives call for the current 

problem list which includes only those 

diagnoses of problems currently 

affecting the patient. Other objectives 

call for the current and historical 

problem list, which would include 

problems currently affecting the patient 

as well as those that have been resolved. 

For purposes of clarity, we are 

consolidating across all of the 

meaningful use objectives to just two 

descriptions of our term ‘‘problem list’’: 

‘‘current problem list’’ and ‘‘current and 

historical problem list.’’ This 

consolidation also removes the need for 

a separate item of past relevant 

diagnosis as these would be included in 

a historical problem list. We define 

active medication list as a list of 

medications that a given patient is 

currently taking. We define active 

medication allergy list as a list of 

medications to which a given patient 

has known allergies. We define allergy 

as an exaggerated immune response or 

reaction to substances that are generally 

not harmful. Information on problems, 

medications, and medication allergies 

could be obtained from previous 

records, transfer of information from 

other providers (directly or indirectly), 

diagnoses made by the EP or hospital, 

new medications ordered by the EP or 

in the hospital, or through querying the 

patient. In the event that there are no 

current or active diagnoses for a patient, 

the patient is not currently taking any 

medications, or the patient has no 

known medication allergies, 

confirmation of no problems, no 

medications, or no medication allergies 

would satisfy the measure of this 

objective. 

Comment: Many commenters 

recommended against any specification 

of problem list content regarding 

functional and cognitive limitations 

citing insufficient consensus around the 

appropriate classification of these 

functions. Commenters also stated that 

if included, functional and cognitive 

limitations should be further defined. 

Response: As noted earlier in this 

final rule under the demographic 

objective, we wish to clarify that both 

the concepts of physical and cognitive 

disabilities as well as the concept of 

functional limitations that impact an 

individual’s capability to perform 

activities were included in our 

description of disability status for the 

purpose of this rule. The latter concept 

is a common metric for care planning 

and care coordination across settings 

because knowledge of a patient’s 

abilities (for example, functional and/or 

cognitive status) are also necessary for 

clinical practice. While many 

commenters noted the lack of consensus 

for the terms and standards necessary to 

support the inclusion of disability, 

functional and cognitive status 

assessment and observations into the 

Consolidated CDA for summary of care 

records, we understand that this 

standard was updated to include 

section- and data-entry level templates 

that can describe a patient’s functional 

and cognitive status. However, we agree 

that there are insufficient definitions for 

disability, functional and cognitive 

status assessment and observations to 

include them as part of the problem list. 

Therefore, we are including ‘‘functional 

status, including functional, cognitive 

and disability’’ as a separate element in 

the summary of care document. 

Comment: In regard to the inclusion 

of ‘‘care plan field’’ in the list of 

required information, some commenters 

believed that the wording was overly 

prescriptive since CEHRT could utilize 

multiple fields to structure care plans. 

Other commenters requested a more 

detailed definition of care plan and/or 

the standards that are available or 

required. 

Response: We agree that the language 

proposed could be viewed as 

prescriptive, and we do not intend to 

limit the inclusion of the care plan to a 

single field. Therefore, we are amending 

the language to ‘‘Care plan field(s), 

including goals and instructions’’ in our 

list of required elements below. 

However, we decline to provide an 

alternate definition that would limit the 

information in the care plan. We believe 

that the definition we proposed in the 

proposed rule is sufficient to allow for 

the inclusion of a variety of care plans 

in the clinical summary. For purposes of 

the clinical summary, we define a care 

plan as the structure used to define the 

management actions for the various 

conditions, problems, or issues. A care 

plan must include at a minimum the 

following components: Problem (the 

focus of the care plan), goal (the target 

outcome), and any instructions that the 

provider has given to the patient. A goal 

is a defined target or measure to be 

achieved in the process of patient care 

(an expected outcome). 

mstockstill on DSK4VPTVN1PROD with RULES2

54016 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

Comment: Commenters stated that 

while the care team members are clearly 

important data elements and key to 

clinical coordination, they 

recommended further research into true 

standards to support these elements 

before any requirements are imposed. 

Response: Our proposal is to include 

‘‘Any additional known care team 

members beyond the referring or 

transitioning provider and the receiving 

provider’’. We believe that the ability to 

identify providers is well established. 

We note that there is no requirement to 

identify the role of each provider which 

we would agree are not well established 

beyond PCP and referring provider. We 

also note that this is only for cases when 

the other care team members are known 

by the transitioning provider. These 

allowances are sufficient to 

accommodate the current standard 

limitations and therefore we finalize as 

proposed. 

Comment: As referrals are included in 

the denominator as well as transitions of 

care, the summary of care document 

should include the reason for the 

referral. 

Response: We agree with this 

comment and add reason for referral for 

EPs. The reason for the referral is the 

clinical question the referring provider 

wants answered for a consultation or the 

procedure to be performed. If the 

consultation is more open ended, then 

a brief summary of the case details 

pertinent to referral suffices. 

After consideration of the comments, 

all summary of care documents used to 

meet this objective must include the 

following information if the provider 

knows it: 

• Patient name. 

• Referring or transitioning provider’s 

name and office contact information (EP 

only). 

• Procedures. 

• Encounter diagnosis. 

• Immunizations. 

• Laboratory test results. 

• Vital signs (height, weight, blood 

pressure, BMI). 

• Smoking status. 

• Functional status, including 

activities of daily living, cognitive and 

disability status. 

• Demographic information 

(preferred language, sex, race, ethnicity, 

date of birth). 

• Care plan field, including goals and 

instructions. 

• Care team including the primary 

care provider of record and any 

additional known care team members 

beyond the referring or transitioning 

provider and the receiving provider. 

• Discharge instructions (Hospital 

Only). 

• Reason for referral (EP only). 

In circumstances where there is no 

information available to populate one or 

more of the fields listed previously, 

either because the EP, eligible hospital 

or CAH can be excluded from recording 

such information (for example, vital 

signs) or because there is no information 

to record (for example, laboratory tests), 

the EP, eligible hospital or CAH may 

leave the field(s) blank and still meet 

the objective and its associated measure. 

In addition, all summary of care 

documents used to meet this objective 

must include the following in order to 

be considered a summary of care 

document for this objective: 

• Current problem list (Providers may 

also include historical problems at their 

discretion), 

• Current medication list, and 

• Current medication allergy list. 

An EP or hospital must verify these 

three fields for current problem list, 

current medication list, and current 

medication allergy list are not blank and 

include the most recent information 

known by the EP or hospital as of the 

time of generating the summary of care 

document. 

After consideration of public 

comments, we are finalizing this 

objective for EPs at § 495.6(j)(14)(i) and 

for eligible hospitals and CAHs at 

§ 495.6(l)(11)(i) as proposed. 

Proposed Measures: EPs, eligible 

hospitals, and CAHs must satisfy both 

measures in order to meet the objective: 

The EP, eligible hospital or CAH that 

transitions or refers their patient to 

another setting of care or provider of 

care provides a summary of care record 

for more than 65 percent of transitions 

of care and referrals. 

The EP, eligible hospital or CAH that 

transitions or refers their patient to 

another setting of care or provider of 

care electronically transmits a summary 

of care record using CEHRT to a 

recipient with no organizational 

affiliation and using a different CEHRT 

vendor than the sender for more than 10 

percent of transitions of care and 

referrals. 

First Measure: We proposed that if the 

provider to whom the referral is made 

or to whom the patient is transitioned 

has access to the medical record 

maintained by the referring provider, 

then the summary of care record would 

not need to be provided and that patient 

should not be included in the 

denominators of the measures of this 

objective. We stated in the proposed 

rule that different settings within a 

hospital using the same CEHRT would 

have access to the same information, so 

providing a clinical care summary for 

transfers within the hospital would not 

be necessary. 

Comment: If as stated in the proposed 

rule ‘‘the majority chose to defer this 

measure in Stage 1’’, commenters 

asserted this is insufficient information 

to justify raising the threshold to 65 

percent and move the objective to core. 

Other commenters assert that any 

measure that moves from menu to core 

should maintain its Stage 1 threshold 

regardless of the particular measure’s 

rate of deferral. 

Response: After considering the 

arguments for lowering the threshold to 

50 percent and the lack of a robust data 

set in support of the proposed 

threshold, we do lower the threshold to 

50 percent. For this measure in 

particular, we agree that since most 

providers chose to defer this measure in 

Stage 1 the information available on 

performance from Stage 1 meaningful 

EHR users is not as robust as for other 

objectives and measures. We do not 

agree with the comment that all 

objectives that move from menu to core 

should maintain the same threshold. We 

believe such a blanket policy would be 

arbitrary and not properly account for 

the information available for each 

objective and measure. For example, if 

most Stage 1 meaningful EHR users had 

reported on this measure, there would 

be a robust data set of performance on 

which to judge a threshold. A blanket 

policy would ignore such information. 

Comment: Commenters questioned 

and requested clarification on situations 

where the recipient of the transition or 

referral is using the same instance of 

CEHRT or otherwise has access to the 

CEHRT of the transitioning or referring 

provider. Some of these commenters 

acknowledged our proposal to address 

this situation were also split between 

support for our proposal to exclude 

these from the denominator versus 

allowing them to be in the denominator 

and numerator of both measures. Also 

commenters expressed concern on 

whether this was a measurable 

constraint. Finally, commenters 

requested clarification on whether our 

proposal applied to one or both 

measures. 

Response: We proposed that if the 

provider to whom the referral is made 

or to whom the patient is transitioned 

has access to the medical record 

maintained by the referring provider, 

then the summary of care record would 

not need to be provided and that patient 

should not be included in the 

denominators of the measures of this 

objective. We believe that different 

settings within a hospital using CEHRT 

would have access to the same 

information, so providing a clinical care 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54017 

summary for transfers within the 

hospital would not be necessary. This is 

a continuance of our current Stage 1 

policy. In response to comments, this 

policy applies to both measures. We 

clarify the first sentence that access to 

the medical record could be through 

several mechanisms. Some providers 

will be in the same organization and 

share CEHRT outright. Other providers 

might grant remote access to their 

CEHRT to providers not sharing their 

same CEHRT. We do not limit the 

mechanisms through which access is 

granted. We disagree that this access 

should count in the denominator or 

numerator of either measure. A 

summary of care document generated by 

CEHRT conforms to specific standards 

and could in many cases be 

automatically integrated into the 

recipient’s CEHRT. Access provides no 

such capability. For this reason, we 

finalize our policy of excluding these 

transitions and referrals from the 

denominator. However, if a 

transitioning or referring provider 

provides both access and a summary of 

care document to providers outside 

their organization and wishes to include 

them in their denominator and as 

appropriate their numerator, they can 

do so. Finally, while we agree that it 

some cases it may be difficult to 

determine whether the recipient has 

access to the sender’s CEHRT. We do 

not believe that we should remove an 

accommodation due to measurement 

difficulties. It is acceptable for a 

provider to include these transitions 

and referrals in the denominator, but 

only if a summary of care document is 

provided would it count in the 

numerator. 

Comment: Commenters stated that 

there are some providers who may 

engage in a small number of transitions 

of care and referrals and the 

implementation burden of this objective 

is too high to require of those with only 

a small number. This is particularly true 

as the requirement for electronic health 

information exchange is introduced. 

Response: We have previously 

allowed for a more than zero, but less 

than 100 exclusion for our other 

objective requiring electronic health 

information exchange (eRx); therefore, 

in response to these comments we will 

apply that policy to this objective and 

measure as well and raise the exclusion 

from zero to less than 100 transitions of 

care and referrals. Transitions of care 

and referrals are additive so someone 

with 50 transitions of care and 75 

referrals would not qualify for the 

exclusion. 

After consideration of public 

comments, we are revising the measure 

for EPs at § 495.6(j)(14)(ii)(A) and for 

eligible hospitals and CAHs at 

§ 495.6(l)(11)(ii)(A) to ‘‘The EP, eligible 

hospital or CAH that transitions or 

refers their patient to another setting of 

care or provider of care provides a 

summary of care record for more than 

50 percent of transitions of care and 

referrals.’’ 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(b)(l) and (b)(2)(i). 

To calculate the percentage of the first 

measure, CMS and ONC have worked 

together to define the following for this 

objective: 

• Denominator: Number of transitions 

of care and referrals during the EHR 

reporting period for which the EP or 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

was the transferring or referring 

provider. 

• Numerator: The number of 

transitions of care and referrals in the 

denominator where a summary of care 

record was provided. 

• Threshold: The percentage must be 

more than 50 percent in order for an EP, 

eligible hospital, or CAH to meet this 

measure. 

• Exclusion: Any EP who transfers a 

patient to another setting or refers a 

patient to another provider less than 100 

times during the EHR reporting period 

is excluded from all three measures. 

Second Measure: For Stage 2, we 

proposed the additional second measure 

for electronic transmittal because we 

believe that the electronic exchange of 

health information between providers 

will encourage the sharing of the patient 

care summary from one provider to 

another and the communication of 

important information that the patient 

may not have been able to provide, 

which can significantly improve the 

quality and safety of referral care and 

reduce unnecessary and redundant 

testing. Use of common standards can 

significantly reduce the cost and 

complexity of interfaces between 

different systems and promote 

widespread exchange and 

interoperability. In acknowledgement of 

this, ONC has included certain 

transmission protocols in the proposed 

2014 Edition EHR certification criteria. 

These protocols would allow every 

provider with CEHRT to have the tools 

in place to share critical information 

when patients are discharged or 

referred, representing a critical step 

forward in exchange and 

interoperability. Accordingly, we 

proposed to limit the numerator for this 

second measure to only count electronic 

transmissions which conform to the 

transport standards proposed for 

adoption at 45 CFR 170.202 of the ONC 

standards and certification criteria rule. 

To meet the second measure of this 

objective, we proposed that a provider 

must use CEHRT to create a summary of 

care document with the required 

information according to the required 

standards and electronically transmit 

the summary of care document using 

the transport standards to which its 

CEHRT has been certified. No other 

transport standards beyond those 

proposed for adoption as part of 

certification would be permitted to be 

used to meet this measure. 

In the proposed rule, we 

acknowledged the benefits of requiring 

the use of consistently implemented 

transport standards nationwide, but at 

the same time want to be cognizant of 

any unintended consequences of this 

approach. ONC requested comments on 

whether equivalent alternative transport 

standards exist to the ones ONC 

proposes to exclusively permit for 

certification. These comments are 

addressed in the ONC standards and 

certification final rule published 

elsewhere in this issue of the Federal 

Register. We noted in the proposed rule 

that the use of USB, CD–ROM, or other 

physical media or electronic fax would 

not satisfy the measures for electronic 

transmittal of a summary of care record. 

We discussed in the proposed rule, in 

lieu of requiring solely the transmission 

capability and transport standard(s) 

included in a provider’s CEHRT to be 

used to meet this measure, also 

permitting a provider to count 

electronic transmissions in the 

numerator if the provider electronically 

transmits summary of care records to 

support patient transitions using an 

organization that follows Nationwide 

Health Information Network (NwHIN) 

specifications (http://healthit.hhs.gov/ 

portal/server.pt/community/ 

healthit_hhs_gov__nhin_resources/ 

1194). This could include those 

organizations that are part of the NwHIN 

Exchange as well as any organization 

that is identified through a governance 

mechanism ONC would establish 

through regulation. We requested public 

comment on whether this additional 

flexibility should be added to our 

proposed numerator limitations. 

In the proposed rule we raised 

another potential concern that another 

transport standard emerges after CMS’ 

and ONC’s rules are finalized that is not 

adopted in a final rule by ONC as part 

of certification, but nonetheless 

accomplishes the objective in the same 

way. To mitigate this concern, ONC 

indicated in its proposed rule that it 

mstockstill on DSK4VPTVN1PROD with RULES2

54018 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

would pursue an off-cycle rulemaking to 

add as an option for certification 

transport standards that emerge at any 

time after these proposed rules are 

finalized in order to keep pace with 

innovation and thereby allow other 

transport standards to be used and 

counted as part of this measure’s 

numerator. We asked for comments on 

how these standards will further the 

goal of true health information 

exchange. 

Additionally, in order to foster 

standards based-exchange across 

organizational and vendor boundaries, 

we proposed to further limit the 

numerator by only permitting electronic 

transmissions to count towards the 

numerator if they are made to recipients 

that are—(1) not within the organization 

of the transmitting provider; and (2) do 

not have CEHRT from the same EHR 

vendor. 

We proposed these numerator 

limitations because, in collaboration 

with ONC, our experience has shown 

that one of the biggest barriers to 

electronic exchange is the adoption of 

numerous different transmission 

methods by different providers and 

vendors. Thus, we explained that it 

would be prudent for Stage 2 to include 

these more specific requirements and 

conformance to open, national 

standards as it will cause the market to 

converge on those transport standards 

that can best and most readily support 

electronic health information exchange 

and avoid the use of proprietary 

approaches that limit exchange among 

providers. We recognized that because 

the 2011 Edition EHR certification 

criteria did not include specific 

transport standards for transitions of 

care, some providers and vendors 

implemented their own methods for 

Stage 1 to engage in electronic health 

information exchange, some of which 

would no longer be an acceptable means 

of meeting meaningful use if this 

proposal were finalized. 

Therefore, in order to determine a 

reasonable balance that makes this 

measure achievable yet significantly 

advance interoperability and electronic 

exchange, we asked for comment on the 

following concerns stakeholders may 

have relative to the numerator 

limitations we proposed previously. 

We discussed a potential concern 

related to the feasibility of meeting this 

proposed measure if an insufficient 

number of providers in a given 

geographic location (because of upgrade 

timing or some other factor) have EHR 

technology certified to the transport 

standards ONC has proposed to adopt. 

For example, a city might have had a 

widely adopted health information 

exchange organization that still used 

another standard than those proposed 

for adoption by ONC. While it is not our 

intent to restrict providers who are 

engaged in electronic health information 

exchange via other transport standards, 

we believe requiring the use of a 

consistent transport standard could 

significantly further our overarching 

goals for Stage 2. 

We recognized that this limitation 

extends beyond the existing parameters 

set for Stage 1, which specified that 

providers with access to the same 

medical record do not include 

transitions of care or referrals among 

themselves in either the denominator or 

the numerator. We recognized that this 

limitation could severely limit the pool 

of eligible recipients in areas where one 

vendor or one organizational structure 

using the same EHR technology has a 

large market share and may make 

measuring the numerator more difficult. 

We sought comment on the extent to 

which this concern could potentially be 

mitigated with an exclusion or 

exclusion criteria that account for these 

unique environments. We believe the 

limitation on organizational and vendor 

affiliations is important because even if 

a network or organization is using the 

standards, it does not mean that a 

network is open to all providers. Certain 

organizations may find benefits, such as 

competitive advantage, in keeping their 

networks closed, even to those involved 

in the care of the same patient. We 

believe this limitation will help ensure 

that electronic transmission of the 

summary of care record can follow the 

patient in every situation. 

Even without the addition of the 

proposed exclusions under the 

proposed measure, CEHRT would need 

to be able to distinguish between (1) 

electronic transmissions sent using 

standards and those that are not, (2) 

transmission that are sent to recipients 

with the same organizational affiliation 

or not, and (3) transmissions that are 

sent to recipients using the same EHR 

vendor or not. ONC sought comment in 

their proposed certification rule as to 

the feasibility of this reporting 

requirement for CEHRT. 

Despite the possible unintended 

consequences of the parameters we 

proposed for the numerator, in the 

proposed rule we stated that we 

believed that these limitations would 

help ensure that electronic health 

information exchange proceeds at the 

pace necessary to accomplish the goals 

of meaningful use. We asked for 

comments on all these points and 

particularly suggestions that would both 

push electronic health information 

exchange beyond what is proposed and 

minimize the potential concerns 

expressed previously. 

The HIT Policy Committee 

recommended different thresholds for 

EPs and hospitals for the electronic 

transmission measure, with a threshold 

of only 25 instances for EPs. However, 

we proposed a percentage-based 

measure is attainable for both EPs and 

eligible hospitals/CAHs and better 

reflects the actual meaningful use of 

technology. It also provides a more level 

method for measurement across EPs. We 

asked for comments on whether there 

are significant barriers in addition to 

those discussed above to EPs meeting 

the 10 percent threshold for this 

measure. 

Comment: There were several 

comments that doubted that the 

technology will be ready for providers 

to meet this measure. They did not 

believe there is enough vendor support 

to create, customize, and implement the 

changes necessary to meet the new 

measure. Commenters expressed 

concern that many of the technologies, 

from EHRs to HIEs and transmission 

standards, needed to enable electronic 

health information exchange currently 

do not exist. 

Response: We disagree that it is 

premature to include this measure for 

Stage 2. We note that as an incentive 

program it is expected that the 

requirements will reach beyond what is 

commonplace today. Many 

organizations and providers are 

successfully engaged in electronic 

health information exchange today and 

by including this measure in meaningful 

use those established practices will be 

adopted by a greater number of 

providers. 

Comment: A commenter suggested 

that ONC’s certification rule was the 

appropriate place to ensure crossvendor interoperability, not the Stage 2 

measures and objectives. 

Response: While we agree that 

meaningful use should be enabled by 

the capabilities included in 

certification, the concept of meaningful 

use is to incentivize the use of such 

capabilities not just the acquisition of 

them. 

Comment: Commenters expressed two 

concerns on the limitation on the 

numerator that limited it to recipients 

with no organizational affiliation and 

using a different CEHRT vendor. First, 

there was concern that in some markets 

an organization or CEHRT vendor may 

control such a significant share of the 

market that meeting 10 percent is not 

possible. Second, even if the 10 percent 

threshold was feasible in a given 

market, one organization or CEHRT 

vendor may have enough market share 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54019 

that the provider’s referral patterns 

would inappropriately be influenced to 

give preference to those using different 

CEHRT vendors or outside their 

organizations. Commenters support 

appropriate information exchange 

between all providers, where clinically 

relevant, regardless of provider 

affiliations, but have these concerns on 

our proposed measure for this objective. 

Commenters presented several different 

solutions including removing one or 

both limitations, replacing the 

limitations with an error reporting 

system for instances where electronic 

health information exchange fails, 

moving the limitations to the 

denominator and providing exclusions 

for areas of high vendor or 

organizational market penetrations. 

Response: We agree that the measure 

as proposed runs both risks stated by 

commenters. Of the solutions presented 

by commenters, one directly alleviates 

both of these concerns. In drafting the 

final rule, we considered moving the 

limitations from the numerator to the 

denominator of the measure, both 

concerns are addressed. For example, if 

a provider makes 500 referrals during 

the EHR reporting period, 400 of which 

are to providers that either are affiliated 

with the same organization or use the 

same CEHRT vendor, then only 100 

referrals are even eligible for the 

proposed numerator. This creates a bar 

that is much higher than 10 percent, as 

50 percent of the eligible instances must 

be electronically transmitted to meet the 

proposed measure in this example, 

which we agree has the possibility of 

influencing referral patterns. However, 

applying the limitations of ‘‘no 

organizational affiliation’’ and ‘‘different 

CEHRT vendor’’ to the denominator 

instead of the numerator would result, 

in this example, in a denominator of 100 

referrals instead of 500 and a true 10 

percent threshold. There would be no 

need to change referral patterns as there 

would be no negative effect on the 

threshold for having a referral partner 

either in the same organization or using 

the same CEHRT vendor. We firmly 

believe that this solution is the best 

measure of the type of health 

information exchange that we proposed 

to target and that is supported in 

principle by nearly all commenters. 

However, we are not including this 

solution in the final rule as explained in 

the response to the next set of 

comments. Instead, we are removing the 

organizational and vendor limitations 

from this measure solely due to the 

burden of making these determinations 

for measurement. 

Comment: Many commenters 

expressed concern over the ability to 

measure this objective especially the 

organization and vendor limitations. 

Commenters who were providers 

expressed concern over the ability of 

their CEHRT vendor to measure this 

objective, while vendors of CEHRT 

expressed concern over the ability of 

providers to measure the objective. 

Combined, it appears that neither the 

provider nor the vendor believed they 

could even measure on their own and 

had concerns on their partners on which 

they placed their hopes for 

measurement. 

Response: In the proposed rule we 

determined that the CEHRT would have 

to be able to make three determinations 

to successfully calculate the numerator 

for this measure: (1) Electronic 

transmissions sent using standards and 

those that are not; (2) transmissions that 

are sent to recipients with the same 

organizational affiliation or not; and (3) 

transmissions that are sent to recipients 

using the same EHR vendor or not. We 

stated that ONC will seek comment in 

their proposed certification rule as to 

the feasibility of this reporting 

requirement for certified EHR 

technologies. ONC received comments 

similar to ours that making the 

determinations for the numerator was 

infeasible particularly in regard to the 

organizational and vendor limitations. 

Therefore, we are removing the 

organizational and vendor limitations 

from this measure solely due to the 

burden of making these determinations 

for measurement. Commenters did not 

suggest difficulties with determining 

that the electronic transmission was 

sent using the specified standards. 

Therefore, we finalize the stipulation 

that CEHRT be used, including its 

accompanying standards for this 

measure (‘‘measure 2’’). 

However, we are not abandoning all 

efforts to ensure that cross vendor 

electronic exchange is possible for all 

meaningful EHR users in Stage 2. As 

discussed in the prior comment and 

response, the only reason we are not 

finalizing the stipulations on the 

denominator is the measurement 

burden. We believe that a third measure 

is needed that reduces the burden 

relative to the proposed measure, but 

still ensures that all providers have 

implemented CEHRT in a way that 

enables them to electronically exchange 

summary of care documents with a 

recipient using EHR technology 

designed by a different vendor. 

Therefore, we have added a third 

measure (‘‘measure 3’’) that requires 

providers to use their CEHRT to either— 

• Conduct one or more successful 

electronic exchanges of a summary of 

care document, which is counted in 

measure 2 with a recipient who has EHR 

technology designed by a different EHR 

technology developer than the sender’s 

EHR technology certified to 45 CFR 

170.314(b)(2); or 

• Conduct one or more successful 

tests with the CMS designated test EHR 

during the EHR reporting period. 

For the first option in measure 3, the 

sender must verify that the recipient’s 

technology used to receive the summary 

of care record was not designed by the 

same EHR technology developer that 

designed the sender’s EHR technology 

certified to 45 CFR 170.314(b)(2). 

With respect to the second option in 

measure 3, and recognizing past 

difficulties and lessons learned from a 

‘‘test’’ oriented measure in Stage 1, we 

have collaborated with ONC and NIST 

to initiate a project that would result in 

a public facing (hosted online) ‘‘test 

EHR’’ with which EPs, eligible 

hospitals, and CAHs could engage in 

electronic exchange. We expect that 

most providers will satisfy the first 

option in the normal course of meeting 

measure 2. However, in those rare 

instances where that does not occur this 

other second option would give every 

EP, eligible hospital, or CAH an 

alternative method to meet measure 3 

with minimal burden by successfully 

testing electronic exchange with the 

CMS-designated test EHR. If this second 

option is used, we clarify that the use 

of test information about a fictional 

patient that would be identical in form 

to what would be sent about an actual 

patient (for example, ‘‘dummy data’’) 

must be used for the purposes of 

conducting a test with the CMSdesignated test EHR. Providers that use 

the same EHR technology certified to 45 

CFR 170.314(b)(2) and share a network 

for which their organization either has 

operational control or license to use can 

conduct one test that covers all 

providers in the organization. For 

example, if a large group of EPs with 

multiple physical locations use the 

same EHR technology certified to 45 

CFR 170.314(b)(2) and those locations 

are connected using a network that the 

group has either operational control of 

or license to use, then a single test 

would cover all EPs in that group. 

Similarly, if a provider uses an EHR 

technology that is hosted (cloud-based) 

on the developer’s network, then a 

single test would allow all EPs, eligible 

hospitals and CAHs using the EHR 

technology that is hosted (cloud-based) 

on the developer’s network to meet the 

measure. 

While making this does impose a 

burden on the provider, we believe the 

burden is outweighed by the benefits of 

ensuring that every provider who 

mstockstill on DSK4VPTVN1PROD with RULES2

54020 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

becomes a meaningful EHR user is 

capable of exchanging a summary of 

care document electronically regardless 

of who developed the sender’s EHR and 

the recipient’s EHR. 

We also seek to note for readers that 

while we have significantly reduced this 

objective’s burden from what we 

proposed in measure 2, we continue to 

believe that making vendor to vendor 

standards-based exchange attainable for 

all meaningful EHR users is of 

paramount importance. In that regard, 

and as we look toward meaningful use 

Stage 3, we will monitor the ease with 

which EPs, eligible hospitals, and CAHs 

engage in electronic exchange, 

especially across different vendors 

EHRs. If we do not see sufficient 

progress or that continued impediments 

exist such that our policy goals for 

standards-based exchange are not being 

met, we will revisit these more specific 

measurement limitations and consider 

other policies to strengthen the 

interoperability requirements included 

in meaningful use as well as consider 

other policies and regulations through 

which the Department could effect the 

outcome we seek. Finally, we also 

intend to consider future meaningful 

use requirements that increase 

expectations for standards-based 

exchange and make information that is 

exchanged more searchable and usable 

for a broad array of clinical purposes 

imperative to care improvement. We 

envision that these requirements would 

rely on metadata tagging as well as more 

dynamic methods of electronic health 

information exchange. 

Comment: Commenters expressed 

support for including in this measure’s 

numerator electronic transmissions 

enabled by query-based exchange 

models, including organizations using 

NwHIN Exchange specifications. The 

commenters indicated that NwHIN 

Exchange specifications are appropriate 

for exchange use cases not covered as 

well by the Direct standards, and use of 

either standard should be counted. This 

is particularly important in cases where 

the summary is pulled instead of 

pushed. Providers and organizations 

that are part of the NwHIN Exchange or 

other organizations using these 

standards should receive credit for those 

exchanges in meeting interoperability 

measures. 

Response: In Stage 2, all providers 

should be able to use CEHRT to share 

summary of care records in a ‘‘push’’ 

manner to support safe transitions and 

informed referrals. ‘‘Pull’’ (query) 

transactions can also support these 

goals. By ‘‘pull’’ transactions we refer to 

instances where the receiving provider 

retrieves the summary of care document 

from a location outside their own 

CEHRT as opposed to ‘‘push’’ 

transactions where the referring or 

transitioning provider sends the 

summary of care document to the 

receiving provider. Thus, such 

transactions should be counted towards 

the numerator of the provider initiating 

the transitions or referrals when the 

recipient (the provider ‘‘receiving’’ the 

transition or referral) actually receives 

or downloads the patient’s summary of 

care record relevant to the transition or 

referral. The act of uploading the 

summary of care record to a repository 

that can be queried by the recipient— 

without validation that this query in fact 

occurred will not be sufficient to count 

towards the numerator. While we 

acknowledge that there may not be a 

simple, universal way for this to be 

measured, we believe it is important to 

make this accommodation for those who 

elect to engage in this form of exchange. 

Therefore, we are revising the second 

measure to include in the sending 

provider’s numerator instances where 

the recipient receives the summary of 

care record via exchange facilitated by 

an organization that is an NwHIN 

Exchange participant or in a manner 

that is consistent with the governance 

mechanism ONC establishes for the 

nationwide health information network. 

The referring or transitioning provider 

would use their CEHRT to generate a 

summary of care document and to 

provide it an organization that is a 

NwHIN Exchange participant or in a 

manner that is consistent with the 

governance mechanism ONC establishes 

for the nationwide health information 

network. More information on NwHIN 

Exchange participants is available at 

http://healthit.hhs.gov/portal/server.pt/ 

community/ 

healthit_hhs_gov__nhin_exchange/ 

1407. ONC issued a request for 

information regarding a governance 

mechanism for the nationwide health 

information network that is available at 

77 FR 28543. 

After considering the comments 

received, we are modifying the second 

measure for EPs at § 495.6(j)(14)(ii)(B) 

and for eligible hospitals and CAHs at 

§ 495.6(l)(11)(ii)(B) to ‘‘The EP, eligible 

hospital or CAH that transitions or 

refers their patient to another setting of 

care or provider of care provides a 

summary of care record for more than 

10 percent of such transitions and 

referrals either (a) electronically 

transmitted using CEHRT to a recipient 

or (b) where the recipient receives the 

summary of care record via exchange 

facilitated by an organization that is a 

NwHIN Exchange participant or in a 

manner that is consistent with the 

governance mechanism ONC establishes 

for the nationwide health information 

network.’’ 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(b)(l) and (b)(2). 

To calculate the percentage of the 

second measure, CMS and ONC have 

worked together to define the following 

for this objective: 

• Denominator: Number of transitions 

of care and referrals during the EHR 

reporting period for which the EP or 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

was the transferring or referring 

provider. 

• Numerator: The number of 

transitions of care and referrals in the 

denominator where a summary of care 

record was a) electronically transmitted 

using CEHRT to a recipient or b) where 

the recipient receives the summary of 

care record via exchange facilitated by 

an organization that is a NwHIN 

Exchange participant or in a manner 

that is consistent with the governance 

mechanism ONC establishes for the 

nationwide health information network. 

The organization can be a third-party or 

the sender’s own organization. 

• Threshold: The percentage must be 

more than 10 percent in order for an EP, 

eligible hospital or CAH to meet this 

measure. 

• Exclusion: Any EP who transfers a 

patient to another setting or refers a 

patient to another provider less than 100 

times during the EHR reporting period 

is excluded from all three measures. 

Third Measure: After considering the 

comments received, we are adding a 

third measure for EPs at 

§ 495.6(j)(14)(ii)(C) and for eligible 

hospitals and CAHs at 

§ 495.6(l)(11)(ii)(C) to ‘‘An EP, eligible 

hospital or CAH must satisfy one of the 

two following criteria: 

• Conducts one or more successful 

electronic exchanges of a summary of 

care document, which is counted in 

‘‘measure 2’’ (for EPs the measure at 

§ 495.6(j)(14)(ii)(B) and for eligible 

hospitals and CAHs the measure at 

§ 495.6(l)(11)(ii)(B)) with a recipient 

who has EHR technology that was 

designed by a different EHR technology 

developer than the sender’s EHR 

technology certified to 45 CFR 

170.314(b)(2); or 

• Conducts one or more successful 

tests with the CMS designated test EHR 

during the EHR reporting period. 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54021 

capabilities and standards of CEHRT at 

45 CFR 170.314(b)(2). 

• Exclusion: Any EP who transfers a 

patient to another setting or refers a 

patient to another provider less than 100 

times during the EHR reporting period 

is excluded from all three measures. 

(c) Public Health Objectives 

General Public Health Discussion 

In the proposed rule, due to similar 

considerations among the public health 

objectives, we discussed them together. 

Some Stage 2 public health objectives 

are proposed to be in the core set while 

others are proposed to be in the menu 

set. Each objective is identified as either 

core or menu in the following 

discussion. 

• Capability to submit electronic data 

to immunization registries or 

immunization information systems 

except where prohibited, and in 

accordance with applicable law and 

practice. 

• Capability to submit electronic 

reportable laboratory results to public 

health agencies, except where 

prohibited, and in accordance with 

applicable law and practice. 

• Capability to submit electronic 

syndromic surveillance data to public 

health agencies, except where 

prohibited, and in accordance with 

applicable law and practice. 

• Capability to identify and report 

cancer cases to a state cancer registry 

except where prohibited, and in 

accordance with applicable law and 

practice. 

• Capability to identify and report 

specific cases to a specialized registry 

(other than a cancer registry), except 

where prohibited, and in accordance 

with applicable law and practice. 

We proposed the following 

requirements, which will apply to all of 

the public health objectives and 

measures. We proposed that actual 

patient data is required for the 

meaningful use measures that include 

ongoing submission of patient data. 

We discussed in the proposed rule 

situations where PHAs partner with 

health information exchange (HIE) 

organizations to facilitate the 

submission of public health data 

electronically from EHRs. As we stated 

in guidance for Stage 1, (see FAQ 

#10764 at: https:// 

questions.cms.hhs.gov) we clarified that 

such arrangements with HIE 

organizations, if designated by the PHA 

to simply transport the data, but not 

transforming content or message format 

(for example, HL7 format), are 

acceptable for the demonstration of 

meaningful use. Alternatively, if the 

intermediary is serving as an extension 

of the EP, eligible hospital or CAH’s 

CEHRT and performing capabilities for 

which certification is required (for 

example, transforming the data into the 

required standard), then that 

functionality must be certified in 

accordance with the certification 

program established by ONC. In this 

situation, the EP, eligible hospital or 

CAH must still ensure the 

accomplishment of ongoing submission 

of reports to the actual immunization 

information system or registry (whether 

performed by the intermediary or not), 

except in situations when the PHA has 

explicitly designated delivery of reports 

to the intermediary as satisfying these 

requirements. 

We proposed that an eligible provider 

is required to utilize the transport 

method or methods supported by the 

PHA in order to achieve meaningful use. 

Unlike in Stage 1, under our proposed 

Stage 2 criteria a failed submission will 

not meet the objective. An eligible 

provider must either have successful 

ongoing submission or meet an 

exclusion criterion. 

We stated in the proposed rule that 

we expect that CMS, CDC and PHAs 

will establish a process where PHAs 

will be able to provide letters affirming 

that the EP, eligible hospital or CAH 

was able to submit the relevant public 

health data to the PHA. This affirmation 

letter could then be used by the EP, 

eligible hospital or CAH for the 

Medicare and Medicaid meaningful use 

attestation systems, as well as in the 

event of any audit. We requested 

comments on challenges to 

implementing this strategy. 

We proposed to accept a yes/no 

attestation and information indicating to 

which PHA the public health data were 

submitted to support each of the public 

health meaningful use measures. 

Comment: Commenters asked for 

clarification of ongoing submission; 

additionally, due to the amount of time 

needed to prepare for submission of 

data, commenters asked for clarification 

on the timing to determine if a public 

health authority has the capacity to 

accept electronic data for ongoing 

submission. Other commenters noted 

that being ‘‘in queue’’ or in the process 

of validation for ongoing submission 

should count as meeting this measure. 

Commenters also noted that credit 

should be given for having moved into 

ongoing submission during Stage 1. 

Response: To clarify the timing issue, 

the EP or hospital must determine if the 

PHA has the capacity to accept 

electronic data using the specification 

prescribed by ONC for the public health 

information for the objectives of 

meaningful use within the first 60 days 

of the EHR reporting period. If the PHA 

does not have the capacity to accept 

reporting (including situations when the 

PHA accepts electronic data but states it 

lacks capacity to enroll the EP, eligible 

hospital or CAH during that reporting 

period), the EP or hospital can claim an 

exclusion for this measure related to the 

data that cannot be accepted. In 

determining whether the PHA has the 

capacity, CMS anticipates developing a 

centralized repository for this 

information, including a deadline for 

the PHA to submit information. If the 

PHA fails to provide information to this 

centralized repository by the deadline, 

the provider could claim the exclusion. 

In the event, that we are unable to 

develop a centralized repository, 

providers will make the determination 

of PHA capacity by working directly 

with the PHA as is currently the case for 

Stage 1 of meaningful use. If the PHA 

does have the capacity, the measure 

may be satisfied through any of the 

following general public health criteria: 

• Ongoing submission was already 

achieved for an EHR reporting period in 

a prior year and continues throughout 

the current EHR reporting period using 

either the current standard at 45 CFR 

170.314(f)(1) and (f)(2) or the standards 

included in the 2011 Edition EHR 

certification criteria adopted by ONC 

during the prior EHR reporting period 

when ongoing submission was 

achieved. 

• Registration with the PHA or other 

body to whom the information is being 

submitted of intent to initiate ongoing 

submission was made by the deadline 

(within 60 days of the start of the EHR 

reporting period) and ongoing 

submission was achieved. 

• Registration of intent to initiate 

ongoing submission was made by the 

deadline and the EP or hospital is still 

engaged in testing and validation of 

ongoing electronic submission. 

• Registration of intent to initiate 

ongoing submission was made by the 

deadline and the EP or hospital is 

awaiting invitation to begin testing and 

validation. 

The measure will not be met if the 

provider— 

• Fails to register their intent by the 

deadline; or 

• Fails to participate in the onboarding process as demonstrated by 

failure to respond to the PHA written 

requests for action within 30 days on 

two separate occasions. 

Comment: Several commenters 

expressed concern that no data transport 

mechanism was included in the Stage 2 

rule and/or EHR certification. Some 

expressed concern that the lack of a 

mstockstill on DSK4VPTVN1PROD with RULES2

54022 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

standard may result in EPs paying more 

for interfaces than received in incentive 

payments. Other commenters supported 

including no transport mechanism to 

allow maximum flexibility for public 

health authorities. 

Response: While we understand the 

concern of supporting multiple 

transport mechanisms, in order for data 

to flow to public health authority, 

vendors must support the transport 

mechanism utilized by the public health 

authority to which the EP or hospital 

reports. Public health authorities have 

moved to standardize transport 

mechanisms where feasible, and Health 

Information Exchanges are often 

facilitating the transport of data to 

public health. We stand by our policy 

that allows public health authorities to 

dictate the transport mechanism in their 

jurisdiction. Further, we clarify that this 

is independent of the EHR certification 

criteria as EHR certification does not 

address transport for public health 

objectives. 

Comment: Commenters suggested that 

the expectation that public health 

agencies provide affirmation letters is 

too restrictive in accomplishing the goal 

of established a record of 

communication between the provider 

and the PHA. They maintain that there 

are simpler and less burdensome ways 

such as automated acknowledgment 

messages from immunization 

submissions. 

Response: We agree that our proposal 

requiring it must be a letter is too 

restrictive and revise our expectation to 

allow for any written communication 

(which may be in electronic format) 

from the PHA affirming that the EP, 

eligible hospital or CAH was able to 

submit the relevant public health data to 

the PHA. 

Comment: Commenters requested 

greater clarification on what is meant by 

ongoing submission. Some suggested 

that it be transitioned to a percentage 

measurement as with other objectives of 

meaningful use. 

Response: We do not agree that a 

transition to a percentage measurement 

best serves the public health objectives. 

First, a percentage measure would only 

be applicable to those engaged in 

ongoing submission, and as indicated in 

an earlier response, we are allowing four 

different situations to meet the measure. 

Second, we believe that the requirement 

to submit information would be under 

applicable law, the agreements between 

the provider and PHA, or through 

meaningful use which requires 

submissions except where prohibited, 

so it is not necessary for meaningful use 

to monitor the already mandated 

submission. For greater clarification, we 

describe successful ongoing submission 

as electronic submission of reportable 

data during the normal course of a 

provider’s operations. This is not to say 

all data that is reportable is sent to the 

PHA. A provider who is submitting any 

reportable data during their normal 

course of their operations is engaged in 

ongoing submission. A provider that can 

only submit reportable data in a test 

environment or other circumstance that 

is not part of their normal operations 

would not be engaged in ongoing 

submission. 

Where a measure states ‘‘in 

accordance with applicable law and 

practice,’’ this reflects that some public 

health jurisdictions may have unique 

requirements for reporting and that 

some may not currently accept 

electronic data reports. In the former 

case, the proposed criteria for this 

objective will not preempt otherwise 

applicable state or local laws that 

govern reporting. In the latter case, EPs, 

eligible hospitals, and CAHs will be 

excluded from reporting. 

Comment: Several commenters 

requested the removal of ‘‘except where 

prohibited’’ from the objective, while 

others expressed support for this phrase. 

Those that did not support note that 

CMS does not have the authority to 

direct reporting if not required by law 

or regulations, while supporters 

applauded CMS for supporting 

reporting where allowed but not 

required by law. Several commenters 

suggested removing the phrase ‘‘in 

accordance with applicable law,’’ while 

other commenters wrote in support of 

the addition of the phrase. 

Response: We disagree with the 

commenters suggesting removal of these 

phrases and will keep them as part of 

the final rule. The phrase ‘‘except where 

prohibited’’ is meant to allow 

exemptions from reporting for providers 

who cannot by law report to the public 

health authority within their 

jurisdiction. For example, a sovereign 

Indian Nation may not be permitted to 

report immunization registry data to the 

public health authority in their 

jurisdiction. The phrase is meant to 

encourage reporting if a provider is 

authorized to do so. The ‘‘in accordance 

with applicable law’’ phrase allows 

public health authorities to utilize their 

existing laws and regulations for 

reporting. 

Proposed Objective: Capability to 

submit electronic data to immunization 

registries or immunization information 

systems except where prohibited, and in 

accordance with applicable law and 

practice. 

We proposed to include this objective 

in the Stage 2 core set for EPs, eligible 

hospitals and CAHs as recommended by 

the HITPC. We discussed in the 

proposed rule that the Stage 1 objective 

and measure acknowledged that our 

nation’s public health IT infrastructure 

is not universally capable of receiving 

electronic immunization data from 

CEHRT, either due to technical or 

resource readiness. Immunization 

programs, their reporting providers and 

federal funding agencies, such as the 

CDC, ONC, and CMS, have worked 

diligently since the passage of the 

HITECH Act in 2009 to facilitate EPs, 

eligible hospitals and CAHs ability to 

meet the Stage 1 measure. We proposed 

for Stage 2 to take the next step from 

testing to requiring actual submission of 

immunization data. In order to achieve 

improved population health, providers 

who administer immunizations must 

share that data electronically, to avoid 

missed opportunities or duplicative 

vaccinations. Stage 3 is likely to 

enhance this functionality to permit 

clinicians to view the entire 

immunization registry/immunization 

information system record and support 

bi-directional information exchange. 

We proposed that the threshold for 

Stage 2 should move from simply 

testing the electronic submission of 

immunization data (with follow-up 

submission if the test is successful) to 

ongoing submission. However, we asked 

for comments on the challenges that 

moving this objective from the menu set 

to the core set would present for EPs 

and hospitals. 

Comment: Some commenters 

suggested that the term immunization 

information systems was all 

encompassing making the inclusion of 

immunization registries redundant. 

Response: We agree that an 

information system could include 

registries; however, we do not believe 

that modifying the objective serves a 

distinct purpose and could confuse 

those accustomed to the term 

immunization registries. 

Comment: Commenters, although 

supportive of moving immunization 

registry reporting from menu to core, 

expressed concern that PHAs did not 

have the capacity to accept electronic 

data from additional providers. 

Response: We agree that not all PHAs 

will have the resources to onboard 

providers for immunization registry 

reporting. The final rule allows for an 

EP or hospital to be excluded from the 

measure if they operate in a jurisdiction 

for which no immunization registry is 

capable of accepting data. We further 

clarify that this exception applies not 

only if the technical capacity to receive 

the data does not exist, but also if the 

resources are not available within the 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54023 

public health authority to initiate 

ongoing submission with the EP or 

hospital. We also permit (as earlier 

stated) an EP or hospital to meet the 

measure so long as they have registered 

to submit and are either still in the 

process of testing and validation (within 

the time limits established earlier), or 

are still awaiting an invitation to begin 

submission. 

Comment: Numerous commenters 

encouraged the inclusion of 

bidirectional exchange of data with 

immunization registries. Many 

commenters noted that the EP or eligible 

hospital cannot take advantage of rich 

data and clinical decision support 

contained within an immunization 

registry without bidirectional exchange. 

Response: While we agree that the 

need for bidirectional data exchange is 

clear, this measure aligns more with the 

goals of Stage 3 meaningful use stated 

in the proposed rule. Additionally, the 

standards and mechanisms for 

bidirectional data exchange need to be 

more standardized across public health 

authorities. 

After consideration of the public 

comments received, we are finalizing 

this objective for EPs at § 495.6(j)(15)(i) 

and for eligible hospitals and CAHs at 

§ 495.6(l)(12)(i) as proposed. 

Proposed Measure: Successful 

ongoing submission of electronic 

immunization data from CEHRT to an 

immunization registry or immunization 

information system for the entire EHR 

reporting period. 

Comment: Many commenters noted 

the lack of national standards for the 

collection of immunization data with 

specific examples such as CVS versus 

MVX coding vocabularies and also 

noted the need for centralized data 

collection at a national level. 

Commenters noted that the lack of 

standardization results in costprohibitive compliance with this 

measure. 

Response: We agree that during the 

implementation of Stage 1 reporting of 

immunization data, the need for a more 

harmonized standard for immunization 

reporting was highlighted. To address 

this issue, the option of using version 

HL7 2.3.1 versus 2.5.1 for certification 

was removed and now only an HL7 

2.5.1 message can be used for Stage 2 

reporting of immunization data. The 

implementation guide for HL7 2.5.1 has 

been updated to remove much of the 

variability across states for 

immunization registry reporting. 

However, if EPs prior to CY 2014 and 

eligible hospitals and CAHs prior to 

FY2014 have achieved successful 

ongoing submission using EHR 

technology certified to the 2011 Edition 

EHR certification criteria (HL7 2.3.1 

only) it is acceptable to continue this 

ongoing submission and meet the Stage 

2 measure for as long as HL7 2.3.1 

continues to be accepted by the 

immunizations information system or 

immunization registry. EPs and eligible 

hospitals and CAHs conducting 

submissions using HL7 2.5.1 will be 

able to get their arrangement certified to 

the 2014 Edition EHR certification 

criteria. 

After consideration of the public 

comments received, we are finalizing 

this measure at for EPs at 495.6(j)(15)(ii) 

and for eligible hospitals and CAHs at 

495.6(l)(12)(ii) as proposed, but we 

modify the exclusions to conform with 

the general criteria for public health 

objectives and to address redundancy in 

two of the proposed exclusions. In the 

general criteria for public health 

objectives section we established a 

centralized repository of information 

about PHA capacity. If a PHA does not 

provide capacity information to this 

repository in time for it to be made 

available to providers at the start of their 

EHR reporting period, then the 

providers in that PHA’s jurisdiction will 

meet the modified exclusion. We 

proposed two exclusions: (1) The EP, 

eligible hospital or CAH operates in a 

jurisdiction for which no immunization 

registry or immunization information 

system is capable of receiving electronic 

immunization data in the specific 

standards required for CEHRT at the 

start of their EHR reporting period; and 

(2) the EP, eligible hospital or CAH 

operates in a jurisdiction for which no 

immunization registry or immunization 

information system is capable of 

accepting the version of the standard 

that the EP, eligible hospital or CAH’s 

CEHRT can send at the start of their 

EHR reporting period. In both cases the 

limitation is the ability of the 

immunization registry or immunization 

information system to receive 

immunization data in the standards 

required by ONC for EHR certification 

in 2014. Therefore, we are combining 

these exclusions. 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(f)(1) and (f)(2). 

However, if EPs prior to CY 2014 and 

eligible hospitals and CAHs prior to FY 

2014 have achieved successful ongoing 

submission using EHR technology 

certified to the 2011 Edition EHR 

certification criteria (HL7 2.3.1 only), it 

is acceptable to continue this ongoing 

submission and meet the Stage 2 

measure for as long as HL7 2.3.1 

continues to be accepted by the 

immunizations information system or 

immunization registry. We note that our 

decision to continue to permit the use 

of EHR technology certified to the 2011 

Edition EHR certification criteria is a 

special circumstance and emphasize 

that EPs, eligible hospitals, and CAHs 

will still need EHR technology certified 

to the 2014 Edition EHR certification 

criteria in order to meet the CEHRT 

definition beginning with the FY/CY 

2014 EHR reporting period. 

• Exclusions: Any EP, eligible 

hospital or CAH that meets one or more 

of the following criteria may be 

excluded from this objective: (1) The EP, 

eligible hospital or CAH does not 

administer any of the immunizations to 

any of the populations for which data is 

collected by their jurisdiction’s 

immunization registry or immunization 

information system during the EHR 

reporting period; (2) the EP, eligible 

hospital or CAH operates in a 

jurisdiction for which no immunization 

registry or immunization information 

system is capable of accepting the 

specific standards required for CEHRT 

at the start of their EHR reporting period 

(3) the EP, eligible hospital or CAH 

operates in a jurisdiction where no 

immunization registry or immunization 

information system provides 

information timely on capability to 

receive immunization data; or (4) the 

EP, eligible hospital or CAH operates in 

a jurisdiction for which no 

immunization registry or immunization 

information system that is capable of 

accepting the specific standards 

required by CEHRT at the start of their 

EHR reporting period can enroll 

additional EPs, eligible hospitals or 

CAHs. 

The second exclusion will not apply 

if an entity designated by the 

immunization registry or immunization 

information system can receive 

electronic immunization data 

submissions. For example, if the 

immunization registry cannot accept the 

data directly or in the standards 

required by CEHRT, but if it has 

designated a Health Information 

Exchange to do so on their behalf and 

the Health Information Exchange is 

capable of accepting the information in 

the standards required by CEHRT, the 

provider could not claim the second 

exclusion. 

Proposed Eligible Hospital/CAH 

Objective: Capability to submit 

electronic reportable laboratory results 

to public health agencies, except where 

prohibited, and in accordance with 

applicable law and practice. 

We proposed that this objective is in 

the Stage 2 core set for eligible hospitals 

and CAHs. The same rationale for the 

mstockstill on DSK4VPTVN1PROD with RULES2

54024 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

proposed changes between this 

proposed objective and that of Stage 1 

are discussed earlier under the 

immunization registry objective. Please 

refer to that section for details on our 

proposals in this regard. 

Comment: Commenters, although 

supportive of moving electronic 

laboratory reporting from menu to core, 

expressed concern that PHAs did not 

have the capacity to accept electronic 

data from additional providers. 

Response: We agree that not all PHAs 

will have the resources to onboard 

providers for electronic laboratory 

reporting. The final rule allows for an 

EP, eligible hospital or CAH to be 

excluded from the measure if they 

operate in a jurisdiction for which no 

public health authority is capable of 

accepting electronic laboratory data. We 

further clarify that this exception 

applies not only if the technical 

capacity to receive the data does not 

exist, but also if the resources are not 

available within the public health 

authority to initiate ongoing submission 

with the EP, eligible hospital or CAH. 

We also permit (as earlier stated) an EP, 

eligible hospital or CAH to meet the 

measure so long as they have registered 

to submit and are either still in the 

process of testing and validation, or are 

still awaiting an invitation to begin 

submission. 

Comment: Many commenters noted 

that lack of standards for reporting 

electronic laboratory data to public 

health authorities and also noted the 

variety of transport methods needed to 

support reporting to public health. 

Response: ONC has adopted an 

updated implementation guide for 

electronic laboratory reporting from 

EHR technology in its 2014 Edition EHR 

certification criteria. Additionally, the 

Centers for Disease Control and 

Prevention in coordination with the 

Council of State and Territorial 

Epidemiologists have created the 

national Reporting Condition Mapping 

Table (http://www.cdc.gov/

EHRmeaningfuluse/rcmt.html) that 

provides further guidance on 

appropriate vocabularies usable for 

reportable conditions across the country 

for reporting of ELR data. 

Comment: Several commenters wrote 

in favor of expansion of this 

requirement to be inclusive of the 

surveillance of healthcare associated 

infections (HAI). 

Response: While we agree that the 

reporting of healthcare associated 

infections is a critical part of public 

health surveillance, the methods and 

standards for reporting this information 

require very different standards for 

electronic laboratory reporting of 

reportable conditions. This measure 

aligns more with the goals of Stage 3 

meaningful use. 

Comment: Numerous commenters 

suggested that Electronic Laboratory 

Reporting is outside the scope of EHRs 

and should be excluded from the 

objectives. These commenters note that 

laboratory information systems (LIMS) 

already have ELR capabilities, and most 

EHRs do not. One commenter expressed 

concern that reporting from both 

laboratories and providers may cause 

duplicate reporting of a single case. The 

same commenter stated that many LIMS 

systems already have functionality to 

identify which laboratory results need 

to be reported to public health, which 

EHRs do not, and that building that 

capability into EHRs would be 

duplicative and burdensome. 

Response: We disagree with the 

statement that ELR is ‘‘outside the scope 

of EHRs and should be excluded’’ 

because we share ONC’s broad 

interpretation of the term EHR 

technology. Eligible Hospitals can 

choose to report data directly from any 

kind of EHR technology that has been 

certified to the certification criteria 

adopted by ONC. This could include 

EHR technology from a single EHR 

technology developer, a separate 

modularly certified component such as 

a LIMS certified as an EHR Module, or 

the technical capability offered by an 

HIE that is certified as an EHR Module 

for electronic laboratory reporting. 

After consideration of the public 

comments, we are finalizing this 

objective for eligible hospitals and 

CAHs at 495.6(l)(13)(i) as proposed. 

Proposed Eligible Hospital/CAH 

Measure: Successful ongoing 

submission of electronic reportable 

laboratory results from CEHRT to a 

public health agency for the entire EHR 

reporting period as authorized, and in 

accordance with applicable State law 

and practice. 

Please refer to the general public 

health discussion regarding use of 

intermediaries. 

Most comments received related to 

this measure have been addressed in the 

discussion of public health objectives in 

general or in the discussion of the 

objective associated with this measure. 

Comment: Commenters pointed out 

that the proposed measure includes the 

statement ‘‘as authorized, and in 

accordance with applicable State law 

and practice.’’ Some commenters 

believed the phrase was simply 

redundant to the objective and was 

inconsistent with the other public 

health measures. Other commenters 

expressed concern that the addition of 

the phrase implied a more restrictive 

measure than other public health 

measures particularly with the limit to 

state law as opposed to just law. 

Response: We agree with commenters 

that this phrase is redundant to the 

objective and may introduce confusion. 

Therefore, we are revising this measure 

to remove the phrase and make it 

consistent with the other public health 

measures. 

Based on consideration of those 

comments, we are modifying this 

measure for eligible hospitals and CAHs 

at § 495.6(l)(13)(ii) to successful ongoing 

submission of electronic reportable 

laboratory results from CEHRT to a 

public health agency for the entire EHR 

reporting period.’’ We also modify the 

exclusions to conform with the general 

criteria for public health objectives. In 

the general criteria for public health 

objectives, we plan to establish a 

centralized repository of PHA capacity 

information. If a PHA does not provide 

capacity information to this repository 

in time for it to be made available to 

providers at the start of their EHR 

reporting period, then the providers in 

that PHA’s jurisdiction will meet the 

modified exclusion. If the repository is 

not established, the eligible hospital or 

CAH must consult their PHA 

jurisdiction for guidance. 

We further specify that in order to 

meet this objective and measure, an 

eligible hospital or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(f)(4). 

• Exclusions: The eligible hospital or 

CAH that meets one or more of the 

following criteria may be excluded from 

this objective: (1) operates in a 

jurisdiction for which no public health 

agency is capable of receiving electronic 

reportable laboratory results in the 

specific standards required for Certified 

EHR Technology at the start of the EHR 

reporting period; (2) operates in a 

jurisdiction where no public health 

agency provides information timely on 

capability to receive electronic 

reportable laboratory results or (3) the 

eligible hospital or CAH operates in a 

jurisdiction for which no public health 

agency that is capable of accepting the 

specific standards required by CEHRT at 

the start of their EHR reporting period 

can enroll additional eligible hospitals 

or CAHs. 

Proposed Objective: Capability to 

submit electronic syndromic 

surveillance data to public health 

agencies except where prohibited, and 

in accordance with applicable law and 

practice. 

We proposed that this objective is in 

the Stage 2 core set for eligible hospitals 

and CAHs and the Stage 2 menu set for 

EPs. The Stage 1 objective and measure 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54025 

acknowledged that our nation’s public 

health IT infrastructure is not 

universally capable of receiving 

syndromic surveillance data from 

CEHRT, either due to technical or 

resource readiness. Given public health 

IT infrastructure improvements and new 

implementation guidance, for Stage 2, 

we proposed that this objective and 

measure be in the core set for hospitals 

and in the menu set for EPs. It is our 

understanding from hospitals and the 

CDC that many hospitals already send 

syndromic surveillance data. The CDC 

has issued the PHIN Messaging Guide 

for Syndromic Surveillance: Emergency 

Department and Urgent Care Data 

[http://www.cdc.gov/ehrmeaningfuluse/

Syndromic.html] as cited in the ONC 

final rule on EHR standards and 

certification. However, per the CDC and 

a 2010 survey completed by the 

Association of State and Territorial 

Health Officials (ASTHO), very few 

public health agencies are currently 

accepting syndromic surveillance data 

from ambulatory, non-hospital 

providers, and there is no corresponding 

implementation guide at the time of this 

final rule. CDC is working with the 

syndromic surveillance community to 

develop a new implementation guide for 

ambulatory and inpatient discharge 

reporting of syndromic surveillance 

information, which it expects will be 

available in the spring 2013. We 

anticipate that Stage 3 might include 

syndromic surveillance for EPs in the 

core set if the collection of ambulatory 

syndromic data becomes a more 

standard public health practice in the 

interim. 

The HIT Policy Committee 

recommended making this a core 

objective for Stage 2 for EPs and 

hospitals. However, we did not propose 

to adopt their recommendation for EPs. 

We specifically invited comment on the 

proposal to leave syndromic 

surveillance in the menu set for EPs, 

while requiring it in the core set for 

eligible hospitals and CAHs. 

Comment: Commenters noted that 

keeping the objective as menu for EPs is 

still problematic as most public health 

agencies are unable to accept the data. 

Commenters also expressed that for 

providers that are already reporting this 

objective, it makes sense to keep it as a 

menu set option. 

Response: We agree that although not 

all public health authorities are able to 

accept syndromic surveillance data from 

Eligible Professionals, since many EPs 

already report this measure and some 

public health authorities have the 

ability to accept this data, the measure 

will remain as a menu set option. 

Comment: Commenters noted that 

moving the objective as core is 

premature due to public health 

readiness. Commenters also expressed 

that for hospitals that have already 

reporting this objective, it makes sense 

to move the measure to core. 

Response: We agree that not all public 

health authorities are able to accept 

syndromic surveillance data from 

hospitals; however, our exclusion 

criteria addresses this situation. Since 

many hospitals already report this 

measure and many public health 

authorities have the ability to accept 

this data, the measure will remain as 

core. If there are no public health 

authorities for the hospitals to report 

syndromic surveillance data to, the 

hospital can claim an exemption. 

Comment: Many commenters noted 

that lack of standards for reporting 

syndromic surveillance data to public 

health authorities. 

Response: While a single national 

implementation guide exists for 

syndromic surveillance data of 

emergency department data from 

hospitals, currently an implementation 

guide does not exist for syndromic 

surveillance reporting from the eligible 

professional. The Centers for Disease 

Control and Prevention is working in 

conjunction with the International 

Society for Disease Surveillance and 

draft guidance is currently available for 

the reporting of ambulatory based 

syndromic surveillance. 

Comment: Several comments 

expressed concern about the level of 

reporting. Concern was expressed from 

entities with multiple locations that 

would need to report by facility or 

provider lever rather than as an 

organization. 

Response: Currently public health 

departments that collect syndromic 

surveillance data streamline the data 

collection process and collect data at an 

organization or facility level depending 

on the provider. Syndromic surveillance 

data is not collected at the provider 

level, although attestation would be at 

the provider level where reporting by a 

single organization or facility could 

count for multiple providers. 

After consideration of the public 

comments received, we are finalizing 

this objective for EPs in the menu set at 

§ 495.6(k)(3)(i) and for eligible hospitals 

and CAHs in the core set at 

§ 495.6(l)(14)(i) as proposed. 

Proposed Measure: Successful 

ongoing submission of electronic 

syndromic surveillance data from 

CEHRT to a public health agency for the 

entire EHR reporting period. 

All comments received related to this 

measure have been addressed in the 

discussion of public health objectives in 

general or in the discussion of the 

objective associated with this measure. 

After consideration of these public 

comments, we are finalizing this 

measure as proposed for EPs in the 

menu set at § 495.6(k)(3)(ii) and for 

eligible hospitals and CAHs in the core 

set at § 495.6(l)(14)(ii) as proposed, but 

we modify the exclusions to conform 

with the general criteria for public 

health objectives and to address 

redundancy in two of the proposed 

exclusions. In the general criteria for 

public health objectives, we plan to 

establish a centralized repository of 

PHA capacity information. If a PHA 

does not provide capacity information 

to this repository in time for it to be 

made available to providers at the start 

of their EHR reporting period, then the 

providers in that PHA’s jurisdiction will 

meet the modified exclusion. We 

proposed two exclusions: (1) The EP, 

eligible hospital, or CAH operates in a 

jurisdiction for which no public health 

agency is capable of receiving electronic 

syndromic surveillance data in the 

specific standards required for Certified 

EHR Technology at the start of their 

EHR reporting period; and (2) the EP, 

eligible hospital, or CAH operates in a 

jurisdiction for which no public health 

agency is capable of accepting the 

version of the standard that the EP’s, 

eligible hospital’s or CAH’s CEHRT can 

send at the start of their EHR reporting 

period. In both cases the limitation is 

the ability of the PHA to receive 

syndromic surveillance data in the 

standards required by ONC for EHR 

certification in 2014. Therefore, we are 

combining these exclusions. 

We expect that the CDC will be 

issuing (in Spring 2013) the CDC PHIN 

Messaging Guide for Ambulatory 

Syndromic Surveillance and we may 

rely on this guide to determine which 

categories of EPs will not collect such 

information. 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(f)(3). However, if EPs 

prior to CY 2014 and eligible hospitals 

and CAHs prior to FY 2014 have 

achieved successful ongoing submission 

using EHR technology certified to the 

2011 Edition EHR certification criteria 

(HL7 2.3.1 only), it is acceptable to 

continue this ongoing submission and 

meet the Stage 2 measure for as long as 

HL7 2.3.1 continues to be accepted by 

the PHA in that jurisdiction. We note 

that our decision to continue to permit 

the use of EHR technology certified to 

the 2011 Edition EHR certification 

criteria is a special circumstance and 

mstockstill on DSK4VPTVN1PROD with RULES2

54026 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

emphasize that EPs, eligible hospitals, 

and CAHs will still need EHR 

technology certified to the 2014 Edition 

EHR certification criteria in order to 

meet the CEHRT definition beginning 

with the FY/CY 2014 EHR reporting 

period. 

• Exclusions: Any EP, eligible 

hospital or CAH that meets one or more 

of the following criteria may be 

excluded from this objective: (1) the EP 

is not in a category of providers that 

collect ambulatory syndromic 

surveillance information on their 

patients during the EHR reporting 

period; (2) the eligible hospital or CAH 

does not have an emergency or urgent 

care department; (3) the EP, eligible 

hospital, or CAH operates in a 

jurisdiction for which no public health 

agency is capable of receiving electronic 

syndromic surveillance data in the 

specific standards required by CEHRT at 

the start of their EHR reporting period; 

(4) the EP, eligible hospital or CAH 

operates in a jurisdiction where no 

public health agency provides 

information timely on capability to 

receive syndromic surveillance data; or 

(5) the EP, eligible hospital or CAH 

operates in a jurisdiction for which no 

public health agency that is capable of 

accepting the specific standards 

required by CEHRT at the start of their 

EHR reporting period can enroll 

additional EPs, eligible hospitals or 

CAHs. 

As was described under the 

immunization registry measure, the 

third and fourth exclusions do not apply 

if the PHA has designated an HIE 

organization or other intermediary to 

collect this information on its behalf 

and that intermediary can do so in the 

specific Stage 2 standards and/or the 

same standard as the provider’s CEHRT. 

An urgent care department delivers 

ambulatory care, usually on an 

unscheduled, walk-in basis, in a facility 

dedicated to the delivery of medical 

care, but not classified as a hospital 

emergency department. Urgent care 

centers are primarily used to treat 

patients who have an injury or illness 

that requires immediate care but is not 

serious enough to warrant a visit to an 

emergency department. Often urgent 

care centers are not open on a 

continuous basis, unlike a hospital 

emergency department, which will be 

open at all times. 

(d) New Core and Menu Set Objectives 

and Measures for Stage 2 

We proposed the following objectives 

for inclusion in the core set for Stage 2: 

‘‘Provide patients the ability to view 

online, download, and transmit 

information about a hospital admission’’ 

and ‘‘Automatically track medication 

orders using an electronic medication 

administration record (eMAR)’’ for 

hospitals; ‘‘Use secure electronic 

messaging to communicate with 

patients’’ for EPs. We proposed all other 

new objectives for inclusion in the 

menu set for Stage 2. While the HIT 

Policy Committee recommended making 

all objectives mandatory and 

eliminating the menu option, we believe 

a menu set is necessary for some of 

these new objectives in order to give 

providers an opportunity to implement 

new technologies and make changes to 

workflow processes and to provide 

maximum flexibility for providers in 

specialties that may face particular 

challenges in meeting new objectives. 

Proposed Objective: Imaging results 

and information are accessible through 

CEHRT. 

In the proposed rule, we outlined the 

following benefits for this objective. 

Making the image that results from 

diagnostic scans and accompanying 

information accessible through CEHRT 

increases the utility and efficiency of 

both the imaging technology and the 

CEHRT. The ability to share the results 

of imaging scans will likewise improve 

the efficiency of all health care 

providers and increase their ability to 

share information with their patients. 

This will reduce the cost and radiation 

exposure from tests that are repeated 

solely because a prior test is not 

available to the provider. 

We stated in the proposed rule that 

most of the enabling steps to 

incorporating imaging relate to the 

certification of EHR technologies. As 

with the objective for incorporating lab 

results, we encourage the use of 

electronic exchange to incorporate 

imaging results into the CEHRT, but in 

absence of such exchange it is 

acceptable to manually add the image 

and accompanying information to 

CEHRT. 

Comment: Some commenters 

expressed concerns over the ability of 

CEHRT to store the images. 

Response: We did not propose that 

CEHRT store the images. Storing the 

images natively in CEHRT is one way to 

make them accessible through CEHRT, 

but there are many other ways. 

Comment: Commenters stated that 

unless a HIE organization existed to 

facilitate imaging exchange, building 

out an unique interface for each imaging 

provider is cost prohibitive. Second, 

commenters were concerned that 

because stand-alone radiology centers 

are not subject to the EHR Incentive 

Program they may not agreeing to 

provide their images electronically to 

the provider through their EHR. These 

commenters therefore suggest that it is 

premature to include this objective. 

Response: We agree that many 

advances in infrastructure are needed to 

fully enable this objective. We believe 

that from publication of this final rule 

to the start of Stage 2 significant 

progress will be made in part due to the 

inclusion of this objective in Stage 2. 

We do agree that these improvements in 

infrastructure will vary based on local 

conditions such as the presence of HIEs, 

the willingness of radiology centers to 

link to EHRs, and other factors and note 

that is a primary reason for this being 

a menu objective. We will also consider 

these comments below in relation to 

setting the threshold for the measure. 

Comment: The resolution required for 

viewing imaging for diagnostic purposes 

requires specific hardware which would 

be cost prohibitive for all EPs. CMS 

should clarify that the image can be of 

any resolution. 

Response: We do not impose 

limitations on the resolution of the 

image. To the extent this is a concern, 

it would be a capability of CEHRT not 

a requirement of meaningful use. 

Comment: Commenters requested 

clarification on whether both the image 

itself and the accompanying results and 

information must be available, or just 

one or the other. 

Response: The objective as proposed 

was intended to convey that the image 

itself is the result and that narratives/ 

explanations and other information 

would be the additional information. 

Due to the many comments we received 

requesting clarification, we are revising 

the objective for clarity. 

Comment: Commenters requested a 

more specific definition of imaging. 

Response: We believe that imaging is 

a well understood term in the provider 

community. However, we agree that a 

more specific definition is required for 

purposes of measuring meaningful use. 

We adopt the description of radiology 

services from the Stage 2 CPOE 

objective as the minimum description of 

imaging. Providers are free to use a more 

expansive definition of imaging. 

After review of the comments, we are 

revising the objective for EPs at 495.6 

(k)(1)(i) and for eligible hospitals and 

CAHs at 495.6(m)(2)(i) to ‘‘Imaging 

results consisting of the image itself and 

any explanation or other accompanying 

information are accessible through 

CEHRT.’’ 

Proposed Measure: More than 40 

percent of all scans and tests whose 

result is one or more images ordered by 

the EP or by an authorized provider of 

the eligible hospital or CAH for patients 

admitted to its inpatient or emergency 

department (POS 21 or 23) during the 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54027 

EHR reporting period are accessible 

through CEHRT. 

For Stage 2, we did not propose the 

image or accompanying information (for 

example, radiation dose) be required to 

be structured data. Images and imaging 

results that are scanned into the CEHRT 

may be counted in the numerator of this 

measure. We defined accessible as 

either incorporation of the image and 

accompanying information into CEHRT 

or an indication in CEHRT that the 

image and accompanying information 

are available for a given patient in 

another technology and a link to that 

image and accompanying information. 

Incorporation of the image means that 

the image and accompanying 

information is stored by the CEHRT. We 

did not propose that meaningful use 

would impose any additional retention 

requirements on the image. A link to the 

image and accompanying information 

means that a link to where the image 

and accompanying information is stored 

is available in CEHRT. This link must 

conform to the certification 

requirements associated with this 

objective in the ONC final rule 

published elsewhere in this issue of the 

Federal Register. We encouraged 

comments on the necessary level of 

specification and what those 

specifications should be to define 

accessible and what constitutes a direct 

link. 

Comment: Commenters suggested that 

the proposed threshold of 40 percent 

was too high given the dependency on 

the image provider and electronic 

exchange infrastructure discussed in the 

objective. The most popular suggested 

threshold was 10 percent. Commenters 

also suggested that an exclusion be 

created for providers who have no 

access to electronic images. A few of the 

commenters pointed to the lack of an 

imaging provider that could make 

electronic images available. Others were 

concerned that when a provider uses 

multiple imaging providers, 40 percent 

might be too high of a threshold even if 

at least one imaging provider that could 

make electronic images available. 

Response: After reviewing the 

comments, we agree that 40 percent is 

too high of a threshold for this measure 

and revise it to 10 percent. Providers, 

especially EPs, may use many imaging 

providers, and we do not want an EP to 

have to defer this objective simply 

because they have three imaging 

providers, and the one allowing 

electronic access represents less than 40 

percent of their orders. The comment 

regarding complete lack of an imaging 

provider that could make electronic 

images available speaks to the need for 

an exclusion. In considering an 

exclusion for those providers who have 

no access to electronic images, we take 

into account that it is a menu objective 

and also that there may be providers 

who fall into a situation where access is 

more than zero, but less than 10 percent. 

In regards to the menu, while it is true 

that a provider may defer this measure, 

the number of measures in the menu set 

are fewer and more specialized than in 

Stage 1. Furthermore, as an exclusion no 

longer counts towards meeting a menu 

objective, we are not concerned 

providers would choose this objective 

only to exclude it. For this reason, we 

are finalizing an exclusion for providers 

who have no access to electronic 

images. For those who cannot meet the 

10 percent threshold even with access to 

an imaging provider who makes 

electronic images available, deferral 

remains a possibility as well as shifting 

more orders to imaging providers that 

do allow electronic access. 

Comment: Several commenters 

disagreed with the proposed exclusion 

for EPs and believed it was inconsistent 

with the objective. These commenters 

believe the objective is intended for EPs 

who order imaging, whether or not they 

interpret the imaging studies 

themselves. These commenters 

suggested changing the exclusion to 

‘‘Any EP who orders (less than 100/50/ 

no) diagnostic scans or tests whose 

result is an image during the EHR 

reporting period’’. 

Response: Our intention with the 

proposed exclusion was to distinguish 

between ordering providers who have 

need of the image and those that do not. 

Based on the comments the need to 

view the image depends on a 

combination of factors including 

previous experiences with the type of 

image, the imaging facility, the 

circumstances of the patient, whether a 

similar image has been ordered before 

for the patient and the reading clinician. 

Given the wide variety of factors, we 

agree that it is not possible to create a 

distinct line between ordering providers 

who need the image and those that do 

not. We believe this line can be partly 

drawn by adopting the exclusion 

recommended by comments with a high 

count of 100. This is both consistent 

with our other objectives and as a high 

number indicates a particular benefit to 

the provider as well as increasing the 

likelihood that factors align for the 

ordering provider to need the image. 

Comment: Commenters stated that the 

use of the term ‘‘scan’’ is confusing and 

unnecessary. Scan frequently applies to 

actions and concepts other than certain 

types of imaging procedures. 

Response: We agree that the term scan 

has multiple uses, as any scan would be 

an image and could be classified as a 

test. Therefore, we remove the word 

scan from the measure as duplicative. 

After reviewing the comments, we 

modify the measure for EPs at § 495.6 

(k)(1)(ii) and for eligible hospitals and 

CAHs at § 495.6(m)(2)(ii) to: More than 

10 percent of all tests whose result is 

one or more images ordered by the EP 

or by an authorized provider of the 

eligible hospital or CAH for patients 

admitted to its inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period are accessible 

through CEHRT. 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(a)(12). 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this measure: 

• Denominator: Number of tests 

whose result is one or more images 

ordered by the EP or by an authorized 

provider on behalf of the eligible 

hospital or CAH for patients admitted to 

its inpatient or emergency department 

(POS 21 and 23) during the EHR 

reporting period. 

• Numerator: The number of results 

in the denominator that are accessible 

through CEHRT. 

• Threshold: The resulting percentage 

must be more than 10 percent in order 

to meet this measure. 

• Exclusion: Any EP who orders less 

than 100 tests whose result is an image 

during the EHR reporting period; or 

Any EP who has no access to 

electronic imaging results at the start of 

the EHR reporting period. 

No access means that none of the 

imaging providers used by the EP 

provide electronic images and any 

explanation or other accompanying 

information that are accessible through 

their CEHRT at the start of the EHR 

reporting period. 

We solicited comments on a potential 

second measure for this objective that 

would encourage the exchange of 

imaging and results between providers. 

We considered a threshold of 10 percent 

of all scans and tests whose result is one 

or more images ordered by the EP or by 

an authorized provider of the eligible 

hospital or CAH for patients admitted to 

its inpatient or emergency department 

(POS 21 or 23) during the EHR reporting 

period and accessible through CEHRT 

also be exchanged with another 

provider of care. 

Comment: While most commenters 

agree with the principle of exchange of 

images among providers of care, they 

nearly all agreed that this measure 

would be premature for Stage 2 due to 

mstockstill on DSK4VPTVN1PROD with RULES2

54028 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

infrastructure concerns. Some suggested 

that it be considered for Stage 3 as a 

logical next step from our proposed 

Stage 2 measure. 

Response: Given the comments, we 

are not including this measure in our 

final rule. We will consider the input 

provided when we develop our proposal 

for Stage 3. 

Proposed Objective: Record patient 

family health history as structured data 

In the proposed rule, we noted that 

every provider currently requests a 

family health history from the patient in 

order to obtain it. However, EHRs can 

allow the patient to contribute directly 

to the record and allow the record to be 

shared among providers, thereby greatly 

increasing the efficiency of collecting 

family health histories. Family health 

history is a major risk indicator for a 

variety of chronic conditions for which 

effective screening and prevention tools 

are available. 

Comment: Commenters generally 

supported the inclusion of recording 

family health history as a menu set 

measure for EPs, eligible hospitals and 

CAHs, while some suggested deferring 

the measure until Stage 3 when they 

expect more robust standards will be 

available. Some commenters also 

suggested family health history is best 

collected by primary care physicians, 

not hospitals. Others still suggested 

modifying this objective to allow for the 

use of unstructured data. 

Response: ONC has adopted standards 

requiring CEHRT to be able to use 

SNOMED–CT or the HL7 Pedigree 

standard to record a patient’s family 

health history. We refer readers to 

ONC’s standards and certification 

criteria final rule that is published 

elsewhere in this issue of the Federal 

Register. As a readily available standard 

is being adopted, we are maintaining 

this objective as proposed and including 

it in the menu set. We continue to 

believe that family history is part of 

regular physician and hospital 

workflow—even if it’s collected at a 

very high level. While it may primarily 

be the physicians working in the 

hospital that consider this information, 

these same physicians typically use the 

hospital EHR when evaluating their 

hospitalized patients so having this 

information in the hospital EHR is just 

as important as having it in the 

physician’s own EHR. We will also 

finalize the exclusion for EPs who have 

no office visits during the EHR reporting 

period to account for scope of practice 

concerns and the common collection of 

this information directly from patients. 

After consideration of public 

comments, we are finalizing this 

objective for EPs at § 495.6 (k)(2)(i) and 

for eligible hospitals and CAHs at 

§ 495.6(m)(3)(i) as proposed. 

Proposed Measure: More than 20 

percent of all unique patients seen by 

the EP, or admitted to the eligible 

hospital or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period have a 

structured data entry for one or more 

first-degree relatives. 

We proposed to adopt the definition 

of first degree relative used by the 

National Human Genome Research 

Institute of the National Institutes of 

Health. A first degree relative is a family 

member who shares about 50 percent of 

their genes with a particular individual 

in a family. First degree relatives 

include parents, offspring, and siblings. 

We considered other definitions, 

including those that address both 

affinity and consanguinity relationships 

and encourage comments on this 

definition. We noted that this is a 

minimum and not a limitation on the 

health history that can be recorded. We 

did not propose a time limitation on the 

indication that the family health history 

has been reviewed. The recent nature of 

this capability in EHRs will impose a de 

facto limitation on review to the recent 

past. 

We proposed an exclusion to this 

measure for EPs who have no office 

visits during the EHR reporting period. 

We believe that EPs who do not have 

office visits will not have the face-toface contact with patients necessary to 

obtain family health history 

information. 

Comment: Many commenters 

wondered why recording family health 

history was limited to first-degree 

relatives. They noted that a patient’s 

grandparents or other relatives may 

have equally relevant medical 

information that should be included in 

the EHR. Other commenters pointed out 

that not all patients may know their 

family health history, particularly 

patients who were adopted, and 

suggested including a code for 

‘‘unknown’’ or ‘‘not relevant.’’ They 

noted that in some cultures, the patient 

may not be willing to provide the data 

or that the data they have may be 

unreliable (such as informal adoptions 

in Native American tribes). 

Response: While information about 

second degree relatives may be useful 

for some diagnoses and conditions, we 

believe collecting medical history from 

first degree relatives is the floor, not the 

ceiling and encourage providers to 

collect additional information as they 

see fit. Additionally, we understand 

concerns about patients who may not 

know their family history. In these 

situations, we would find it acceptable 

for the provider to record the patient’s 

family history as ‘‘unknown.’’ Either a 

structured data entry of ‘‘unknown’’ or 

any structured data entry identified as 

part of the patient’s family history and 

conforming to the standards of CEHRT 

at 45 CFR 170.314(a)(13) must be in the 

provider’s CEHRT for the patient to 

count in the numerator. 

Comment: Some commenters 

suggested we introduce this measure 

with a lower threshold as this is a new 

requirement, but did not specify a 

threshold. They noted that providers 

who might have previously captured 

family history might not have that in a 

structured format or not coded against 

the standards chosen for CEHRT. This 

history would have to be redocumented. 

Response: We proposed a low 

threshold of 20 percent. As this measure 

is not reliant on other organizations and 

providers the way imaging is we do not 

believe that is necessary to lower the 

threshold further. 

Comment: Some commenters 

suggested this measure may not apply to 

certain specialty providers (for example, 

Urgent Care, Orthopedics) and 

suggested including an exclusion. 

Response: We proposed an exclusion 

to this measure for EPs who have no 

office visits during the EHR reporting 

period. We continue to believe that EPs 

who do not have office visits would not 

have the face-to-face contact with 

patients necessary to obtain family 

health history information. However, 

this exclusion may not apply to certain 

specialty providers (like the 

aforementioned). We continue believe 

that recording family health history, 

regardless of specialty, is can be an 

important indicator for chronic 

conditions. Additionally, as this 

measure is being finalized as part of the 

menu set, providers are not required to 

report on this objective. 

After consideration of public 

comments, we are finalizing the 

measure for EPs at § 495.6(k)(2)(ii) and 

for eligible hospitals and CAHs at 

§ 495.6(m)(3)(ii) to ‘‘More than 20 

percent of all unique patients seen by 

the EP, or admitted to the eligible 

hospital or CAH’s inpatient or 

emergency department (POS 21 or 23), 

during the EHR reporting period have a 

structured data entry for one or more 

first-degree relatives’’. 

We are finalizing the exclusion as 

proposed at § 495.6(k)(2)(iii). 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(a)(13). 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54029 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of unique 

patients seen by the EP or admitted to 

the eligible hospital’s or CAH’s 

inpatient or emergency departments 

(POS 21 or 23) during the EHR reporting 

period. 

• Numerator: The number of patients 

in the denominator with a structured 

data entry for one or more first-degree 

relatives. 

• Threshold: The resulting percentage 

must be more than 20 percent in order 

to meet this measure. 

• Exclusion: Any EP who has no 

office visits during the EHR reporting 

period. 

Proposed EP Objective: Capability to 

identify and report cancer cases to a 

state cancer registry, except where 

prohibited, and in accordance with 

applicable law and practice. 

We outlined the following benefits of 

this objective in the proposed rule. 

Reporting to cancer registries by EPs 

would address current underreporting 

of cancer, especially certain types. In 

the past most cancers were diagnosed 

and/or treated in a hospital setting and 

data were primarily collected from this 

source. However, medical practice is 

changing rapidly and an increasing 

number of cancer cases are never seen 

in a hospital or are cared for primarily 

in the outpatient setting. Data collection 

from EPs presents new challenges since 

the infrastructure for reporting is less 

mature than it is in hospitals. Certified 

EHR technology can address this barrier 

by identifying reportable cancer cases 

and treatments to the EP and facilitating 

electronic reporting either automatically 

or upon verification by the EP. 

We proposed to include ‘‘except 

where prohibited and in accordance 

with applicable law and practice’’ 

because we want to encourage all EPs to 

submit cancer cases, even in rare cases 

where they are not required to by state/ 

local law. Legislation requiring cancer 

reporting by EPs exists in 49 states with 

some variation in specific requirements, 

per the 2010 Council of State and 

Territorial Epidemiologists (CSTE) State 

Reportable Conditions Assessment 

(SRCA) (http://www.cste.org/dnn/

ProgramsandActivities/PublicHealth

Informatics/StateReportableConditions

QueryResults/tabid/261/Default.aspx).’’ 

If EPs are authorized to submit, they 

should do so even if it is not required 

by either law or practice.’’ In accordance 

with applicable law and practice’’ 

reflects that some public health 

jurisdictions may have unique 

requirements for reporting, and that 

some may not currently accept 

electronic provider reports. In the 

former case, the proposed criteria for 

this objective would not preempt 

otherwise applicable state or local laws 

that govern reporting. In the latter case, 

eligible professionals would be exempt 

from reporting. 

Comment: Nearly all commenters who 

wrote in support of the objective stated 

that the rule would decrease reporting 

burden for EPs because cancer diagnosis 

reporting in mandatory in most states. 

One commenter noted that the rule may 

increase compliance with mandatory 

reporting by reducing time and effort 

needed to submit cancer diagnosis 

report. Also, it was noted that 

incorporation of cancer reporting in 

meaningful use Stage 2 for eligible 

providers will improve completeness 

and quality of cancer reporting. 

Conversely, several of the commenters 

who recommended moving the objective 

to Stage 3 or remove the objective 

completely stated that inclusion of this 

object would place undue burden on 

EPs, especially because primary care 

providers rarely report to cancer 

registries. A commenter noted that the 

necessary EHR functionality currently 

exists primarily in oncology specialty 

EHRs, and EPs may be required to 

purchase additional modules to meet 

this object, and further states that this 

would be cost-prohibitive to EPs who 

only rarely diagnose cancer. One 

commenter suggested that the detailed 

reporting requirements would be too 

time-consuming for most EPs. Another 

commenter questions if responsibility 

for reporting cases, or presumptive 

cases, would shift to primary care 

providers. Other commenters suggest 

that the objective should be removed 

until such time that a national central 

repository can be established to simplify 

point-to-point connections. 

Response: We agree that inclusion of 

this requirement is likely to reduce 

reporting burden for those already 

required to report to cancer registries. 

We also agree with commenters that this 

objective is not relevant to all providers. 

For those EPs who do not meet the 

proposed exclusion of not diagnosing or 

directly treating cancer, yet are not 

already under a requirement to report to 

cancer registries, we note that this is a 

menu objective and can be deferred. 

Between the proposed exclusions and 

the option to defer, we do not believe 

the measure imposes a reporting burden 

on providers who would not normally 

report to cancer registries. 

Comment: The objectives of 

specialized registries and cancer 

registries reporting should be combined. 

Response: In review of comments we 

found no compelling reason to change 

our proposal. No commenter disputed 

that the reporting to cancer registries 

has different level of existing reporting 

requirements and supporting standards 

than other specialized registries. 

Comment: One commenter suggested 

changing the final rule to read, ‘‘public 

health central cancer registry’’ to clearly 

distinguish them from hospital-based 

cancer registries. 

Response: We agree that the term 

public health central cancer registry is 

better than just cancer registries and 

more inclusive than just state cancer 

registries as used in the proposed 

objective, but not the proposed measure. 

After consideration of the public 

comments received, we are modifying 

this objective for EPs at § 495.6 (k)(4)(i) 

to ‘‘Capability to identify and report 

cancer cases to a public health central 

cancer registry, except where 

prohibited, and in accordance with 

applicable law and practice.’’ 

Proposed EP Measure: Successful 

ongoing submission of cancer case 

information from CEHRT to a cancer 

registry for the entire EHR reporting 

period. 

Comment: Commenters are concerned 

that under the proposed menu set 

providers will be required to choose one 

of: (1) Syndromic surveillance; (2) 

submitting to cancer registries; or (3) 

submitting to specialty registries if they 

do not meet the exclusions for all three. 

The commenters believe that CMS 

should be providing physicians with a 

legitimate selection of menu set 

measures from which to choose. 

Response: Stage 2 does contain a more 

specialized and smaller menu set than 

Stage 1. We see this as a natural result 

of moving up the staged path towards 

improved outcomes. We also see it as 

necessary for meaningful use to be 

applicable to all EPs. We use exclusions 

to ensure that only those EPs who create 

reportable data have the obligation 

under meaningful use to report it so this 

would not be a barrier to meeting 

meaningful use. Furthermore, we added 

an objective to the menu set in this final 

rule for EPs so it is no longer true that 

an EP would be required to pick one of 

the three menu objectives mentioned by 

commenters. 

After consideration of the public 

comments received, we are modifying 

this measure for EPs at § 495.6 (k)(4)(ii) 

to ‘‘Successful ongoing submission of 

cancer case information from CEHRT to 

a public health central cancer registry 

for the entire EHR reporting period’’ and 

modify the exclusions to conform with 

the general criteria for public health 

objectives. 

We further specify that in order to 

meet this objective and measure, an EP 

mstockstill on DSK4VPTVN1PROD with RULES2

54030 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

must use the capabilities and standards 

of CEHRT 45 CFR 170.314(a), (c)(l), 

(f)(5), and (f)(6). 

• Exclusions: Any EP that meets at 

least 1 of the following criteria may be 

excluded from this objective: (1) The EP 

does not diagnose or directly treat 

cancer; (2) the EP operates in a 

jurisdiction for which no public health 

agency is capable of receiving electronic 

cancer case information in the specific 

standards required for CEHRT at the 

beginning of their EHR reporting period; 

(3) the EP operates in a jurisdiction 

where no PHA provides information 

timely on capability to receive 

electronic cancer case information; (4) 

the EP operates in a jurisdiction for 

which no public health agency that is 

capable of receiving electronic cancer 

case information in the specific 

standards required for CEHRT at the 

beginning of their EHR reporting period 

can enroll additional EPs. 

Proposed EP Objective: Capability to 

identify and report specific cases to a 

specialized registry (other than a cancer 

registry), except where prohibited, and 

in accordance with applicable law and 

practice. 

In the proposed rule, we outlined the 

following benefits of this objective. We 

believe that reporting to registries is an 

integral part of improving population 

and public health. The benefits of this 

reporting are not limited to cancer 

reporting. We include cancer registry 

reporting as a separate objective because 

it is more mature in its development 

than other registry types, not because 

other reporting is excluded from 

meaningful use. We have included this 

objective to provide more flexibility in 

the menu objectives that EPs can 

choose. We believe that specialized 

registry reporting could provide many 

EPs with meaningful use menu option 

that is more aligned with their scope of 

practice. 

Comment: The overwhelming 

majority of individuals and groups who 

commented on this objective expressed 

concern about the lack of specificity of 

this objective. Their concerns include: 

(1) Lack of specificity of the potential 

types of registries make planning for 

vendors and EPs very difficult; (2) lack 

of information about who would define 

which registries may be included; (3) 

leaving dozens or hundreds of 

possibilities; (4) lack of clarity as to the 

definition of ’specialized registry; (5) 

lack of standards for many registries; (6) 

or potential of needing to comply with 

standards not identified in the proposed 

rule; and (7) lack of public health 

readiness to accept data from EHRs. 

Response: The purpose of this 

objective and measure is to give 

meaningful use credit to those EPs who 

are engaged in ongoing submission with 

specialized registries. It is not expected 

that every EP will select this objective 

and measure from the menu nor even 

that every EP will have the capability to 

submit to a specialized registry. We are 

purposefully general in our description 

of specialized registry because we do 

not wish to exclude certain registries in 

an attempt to be more specific. The only 

limitation we place on our description 

of specialized registries is that the 

specialized registry cannot be 

duplicative of any of the other registries 

included in other meaningful use 

objectives and measures. This means 

that an EP cannot meet the 

immunization, syndromic surveillance 

or cancer objectives and this objective 

by reporting to the same registry. EPs 

who either do not wish to participate 

with a specialized registry or cannot 

overcome the barriers to doing so can 

defer or exclude this measure as their 

situation warrants. 

Comment: Commenters expressed 

support for expansion of the 

requirement to streamline and improve 

surveillance of healthcare-associated 

infections (HAIs), with the goal of 

improving patient care and safety. 

Response: A registry that is focused 

on healthcare associated infections 

could certainly be considered a 

specialized registry. 

After consideration of the public 

comments received, we are finalizing 

this objective for EPs at § 495.6 (k)(5)(i) 

as proposed. 

Proposed EP Measure: Successful 

ongoing submission of specific case 

information from CEHRT to a 

specialized registry for the entire EHR 

reporting period. 

Comment: Since the lack of specificity 

and named standards make it difficult to 

select this measure from the menu set, 

the actual viable measures available in 

the menu set are reduced to four and 

burdensome for providers who may 

need to pay for interfaces, costing the 

EPs extra time and money above the 

cost of the CEHRT. 

Response: Stage 2 does contain a more 

specialized and smaller menu set than 

Stage 1. We see this as a natural result 

of moving up the staged path towards 

improved outcomes. We also see it as 

necessary for meaningful use to be 

applicable to all EPs. We include 

exclusions that allow for those 

providers who do not create reportable 

data so every provider who would is 

required to report public health data 

would have public health data to report. 

Furthermore, we added an objective to 

the menu in this final rule for EPs so it 

is no longer true that an EP would be 

required to pick one of the three menu 

objectives. The purpose of this measure 

is to provide meaningful use credit to 

those providers engaged in the 

beneficial use of CEHRT of participating 

in specialized registries. Other EPs can 

either meet the exclusions or defer this 

objective and thereby avoid the burden 

of compliance with this objective. 

Comment: Given the large number of 

specialized registries, many of which 

have national scope, the exclusions are 

rendered meaningless. 

Response: We agree with this 

comment, and for purposes of the 

exclusion only, we limit it to registries 

sponsored by national specialty 

societies and specialized registries 

maintained by PHAs. We believe this 

provides needed limitations on the 

exclusions. This limitation does not 

apply to the specialized registries that 

can be used to satisfy the measure as the 

benefits are not limited only to reporting 

to registries operated by Public Health 

Agencies or national medical specialty 

organizations. Specialized registries 

operated by patient safety organizations 

and quality improvement organizations 

also enable knowledge generation or 

process improvement regarding the 

diagnosis, therapy and prevention of 

various conditions that affect a 

population. 

After consideration of the public 

comments received, we are finalizing 

this measure for EPs at § 495.6 (k)(5)(ii) 

as proposed, but we modify the 

exclusions to conform with the general 

criteria for public health objectives and 

in response to comments. 

We further specify that in order to 

meet this objective and measure, an EP 

must use the capabilities and standards 

of CEHRT 45 CFR 170.314(f)(5) and 

(f)(6). 

• Exclusions: Any EP that meets at 

least 1 of the following criteria may be 

excluded from this objective: (1) The EP 

does not diagnose or directly treat any 

disease associated with a specialized 

registry sponsored by a national 

specialty society for which the EP is 

eligible, or the public health agencies in 

their jurisdiction; (2) the EP operates in 

a jurisdiction for which no specialized 

registry sponsored by a public health 

agency or by a national specialty society 

for which the EP is eligible is capable 

of receiving electronic specific case 

information in the specific standards 

required by CEHRT at the beginning of 

their EHR reporting period; (3) the EP 

operates in a jurisdiction where no 

public health agency or national 

specialty society for which the EP is 

eligible provides information timely on 

capability to receive information into 

their specialized registries ; or (4) the EP 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54031 

operates in a jurisdiction for which no 

specialized registry sponsored by a 

public health agency or by a national 

specialty society for which the EP is 

eligible that is capable of receiving 

electronic specific case information in 

the specific standards required by 

CEHRT at the beginning of their EHR 

reporting period can enroll additional 

EPs. 

Proposed EP Objective: Use secure 

electronic messaging to communicate 

with patients on relevant health 

information. 

In the proposed rule, we outlined the 

following benefits of using secure 

electronic messaging to communicate 

with patients: Electronic messaging (for 

example, email) is one of the most 

widespread methods of communication 

for both businesses and individuals. The 

inability to communicate through 

electronic messaging may hinder the 

provider-patient relationship. Electronic 

messaging is very inexpensive on a 

transactional basis and allows for 

communication even when the provider 

and patient are not available at the same 

moment in time. The use of common 

email services and the security 

measures that may be used when they 

are sent may not be appropriate for the 

exchange of protected health 

information. Therefore, the exchange of 

health information through electronic 

messaging requires additional security 

measures while maintaining its ease of 

use for communication. While email 

with the necessary safeguards is 

probably the most widely used method 

of electronic messaging, for the 

purposes of meeting this objective, 

secure electronic messaging could also 

occur through functionalities of patient 

portals, PHRs, or other stand-alone 

secure messaging applications. 

We proposed this as a core objective 

for EPs for Stage 2. The additional time 

made available for Stage 2 

implementation made possible the 

inclusion of some new objectives in the 

core set as proposed in the proposed 

rule. We chose to identify objectives 

that address critical priorities of the 

country’s National Quality Strategy 

(NQS) (http://www.healthcare.gov/law/ 

resources/reports/ 

quality03212011a.html), with a focus on 

one for EPs and one for hospitals. 

For EPs, secure electronic messaging 

is critically important to two NQS 

priorities— 

• Ensuring that each person/family is 

engaged as partners in their care; and 

• Promoting effective communication 

and coordination of care. 

Secure messaging could make care 

more affordable by using more efficient 

communication vehicles when 

appropriate. Specifically, research 

demonstrates that secure messaging has 

been shown to improve patient 

adherence to treatment plans, which 

reduces readmission rates. Secure 

messaging has also been shown to 

increase patient satisfaction with their 

care. Secure messaging has been named 

as one of the top ranked features 

according to patients. Also, despite 

some trepidation, providers have seen a 

reduction in time responding to inquires 

and less time spent on the phone. We 

specifically sought comment on whether 

there may be special concerns with this 

objective in regards to behavioral health. 

Comment: Some commenters noted 

that patient engagement and enhanced 

patient-provider communications 

facilitated by an EHR are important 

goals, and secure messaging between 

EPs and patients is an appropriate 

objective to consider for Meaningful Use 

criteria. 

Response: We appreciate the 

commenters support of this objective 

and agree that electronic patientprovider communication is important to 

improving the overall quality of patient 

care. 

Comment: Some commenters 

suggested that this objective should be 

part of the menu set instead of a core 

objective for Stage 2. This would permit 

EPs who do not believe they can meet 

the measure at this time to select 

different objectives. 

Response: As we noted in the 

proposed rule, we placed this objective 

in the core because we believe it 

addresses critical priorities of the 

country’s National Quality Strategy 

(NQS) (http://www.healthcare.gov/law/ 

resources/reports/ 

quality03212011a.html): Ensuring that 

each person/family is engaged as 

partners in their care; and promoting 

effective communication and 

coordination of care. We also believe 

that secure messaging could make care 

more affordable by using more efficient 

communication vehicles when 

appropriate. Specifically, research 

demonstrates that secure messaging has 

been shown to improve patient 

adherence to treatment plans, which 

reduces readmission rates (see 

Rosenberg SN, Shnaiden TL, Wegh AA, 

Juster IA (2008) ‘‘Supporting the 

patient’s role in guideline compliance: a 

controlled study’’ American Journal of 

Managed Care 14(11):737–44; Gustafson 

DH, Hawkins R, Boberg E, Pingree S, 

Serlin RE, Graziano F, Chan CL (1999) 

‘‘Impact of a patient-centered, 

computer-based health information/ 

support system’’ American Journal of 

Preventive Medicine 16(1):1–9). Secure 

messaging has also been shown to 

increase patient satisfaction with their 

care (see Ralston JD, Carrell D, Reid R, 

Anderson M, Moran M, Hereford J 

(2007) ‘‘Patient Web services integrated 

with a shared medical record: patient 

use and satisfaction’’ Journal of the 

American Medical Informatics 

Association 14(6):798–806). Therefore, 

we are leaving this as a core objective 

for EPs for Stage 2. 

Comment: Several commenters 

responded to our question about 

whether there were special concerns 

about implementing this objective for 

behavioral health patients. These 

commenters indicated that they did not 

believe this objective posed a special 

concern and that it would help 

behavioral health patients obtain 

needed support from clinicians. 

Response: We appreciate the feedback 

from commenters regarding behavioral 

health. 

After consideration of the public 

comments, we are finalizing the 

meaningful use objective for EPs at 

§ 495.6(j)(17)(i) as proposed. 

Proposed EP Measure: A secure 

message was sent using the electronic 

messaging function of CEHRT by more 

than 10 percent of unique patients seen 

by the EP during the EHR reporting 

period. 

Comment: Many commenters voiced 

objections to the measure of this 

objective and the concept of providers 

being held accountable for patient 

actions. The commenters believed that 

while providers could be held 

accountable for making electronic 

messaging capabilities available to 

patients and encouraging patients to use 

electronic messaging, they could not 

control whether patients actually 

utilized electronic messaging. However, 

some commenters believed that the 

measure was a reasonable and necessary 

step to require vendors to make 

electronic messaging tools more widely 

available and for providers to 

incorporate electronic messaging into 

clinical practice. In addition, 

commenters pointed to the unique role 

that providers can play in encouraging 

and facilitating their patients’ and their 

families’ use of secure messaging. 

Response: While we recognize that 

EPs cannot directly control whether 

patients use electronic messaging, we 

continue to believe that EPs are in a 

unique position to strongly influence 

the technologies patients use to improve 

their own care, including secure 

electronic messaging. We believe that 

EPs’ ability to influence patients 

coupled with the low threshold make 

this measure achievable for all EPs. 

Comment: Other commenters did not 

object to the principle of providers 

mstockstill on DSK4VPTVN1PROD with RULES2

54032 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

being held accountable for patient 

actions but noted that the potential 

barriers of limited internet access, 

computer access, and electronic 

messaging platforms for certain 

populations (for example, rural, elderly, 

lower income, visually impaired, nonEnglish-speaking, etc.) might make the 

measure impossible to meet for some 

providers. Commenters suggested a 

number of possible solutions to allow 

providers to overcome these barriers: 

granting exclusions for certain patient 

populations, lowering the proposed 

threshold of the measure, or eliminating 

the percentage threshold of the measure. 

Response: We recognize that certain 

patient populations face greater 

challenges in utilizing electronic 

messaging. We address the potential 

barrier of limited internet access in the 

comment regarding a broadband 

exclusion below. While we agree that 

excluding certain patient populations 

from this requirement would make the 

measure easier for EPs to achieve, we do 

not know of any reliable method to 

quantify these populations for each EP 

in such a way that we could standardize 

exclusions for each population. In 

addition, we are concerned that blanket 

exclusions for certain disadvantaged 

populations could serve to extend 

existing disparities in electronic access 

to health information. We also decline 

to eliminate the percentage threshold of 

this measure because we do not believe 

that a simple yes/no attestation for 

implementation of electronic messaging 

is adequate to encourage a minimum 

level of patient usage. However, in 

considering the potential barriers faced 

by these patient populations, we agree 

that it would be appropriate to lower the 

proposed threshold of this measure to 

more than 5 percent of unique patients 

sending an electronic message. We 

believe that this lower threshold, 

combined with the broadband exclusion 

detailed in the response below, will 

allow all EPs to meet the measure of this 

objective. 

Comment: Several commenters 

suggested that the exclusion for FCCrecognized areas with under 50 percent 

broadband availability, which was 

proposed in the objective to ‘‘Provide 

patients the ability to view online, 

download, and transmit their health 

information,’’ should be extended to the 

electronic messaging objective. 

Response: We agree that the 

infrastructure required for electronic 

messaging is similar to the 

infrastructure required for successful 

usage of an online patient portal as 

described in the objective to ‘‘Provide 

patients the ability to view online, 

download, and transmit their health 

information.’’ Therefore, we believe an 

exclusion to this measure based on the 

availability of broadband is appropriate 

and are finalizing the exclusion in the 

language below. We note that since 

publication of our proposed rule the 

Web site has changed to 

www.broadbandmap.gov and the speed 

used has changed from 4Mbps to 

3Mbps. We updated our exclusion. 

Comment: Some commenters 

expressed concern about including all 

patients seen by the EP in the 

denominator and suggested limiting the 

denominator instead to patients who 

have indicated secure electronic 

messaging as their communication 

preference. Other commenters suggested 

the denominator should not be limited 

to patients seen by the EP and should 

also include patients who make 

inquiries or who attempt to make an 

appointment with the EP during the 

reporting period. 

Response: We do not agree that 

limiting the denominator to patients 

who have indicated secure electronic 

messaging as their communication 

preference is appropriate. The purpose 

of the measure is for EPs to promote 

wider use of electronic messaging as a 

regular communication vehicle for their 

patients, and we are concerned that 

limiting the denominator in the manner 

suggested would not lead to an increase 

in the promotion or usage of electronic 

messaging as an important 

communication vehicle between 

patients and providers. We also do not 

agree that expanding the denominator to 

patients not seen by the EP during the 

reporting period is appropriate. Another 

purpose of the measure is for secure 

messaging to include clinically relevant 

information, and we do not believe that 

patients seeking introductory 

information or making an appointment 

are likely to include clinically relevant 

information in secure messaging. 

Comment: Some commenters noted 

that patients whose only office visit 

with an EP occurs near the end of the 

reporting period might not be able to 

send an electronic message in time to be 

included in the numerator of the 

measure. 

Response: While we agree that 

patients with a single office visit near 

the end of the reporting period may not 

utilize electronic messaging and be 

eligible for inclusion in the numerator 

of the measure during the EHR reporting 

period, we believe that the threshold of 

this measure will be sufficiently low to 

permit EPs to meet the measure even 

without the participation of these 

patients. 

Comment: Several commenters 

requested clarification on the definition 

of a secure message. 

Response: We define a secure message 

as any electronic communication 

between a provider and patient that 

ensures only those parties can access 

the communication. This electronic 

message could be email or the electronic 

messaging function of a PHR, an online 

patient portal, or any other electronic 

means. However, we note that the 

secure message also must use the 

electronic messaging function of CEHRT 

in order to qualify for the measure of 

this objective. 

Comment: Some commenters 

suggested that EPs or patients should be 

permitted to use an electronic 

messaging function that is not part of 

CEHRT in order to meet the measure. 

Response: We believe that allowing 

patients to use multiple electronic 

messaging functions in order to 

communicate with the provider under 

this measure could create confusion for 

the EP and potentially lead to electronic 

messages that are missed or not 

responded to. We also believe that by 

encouraging patients to use the 

electronic messaging function that is 

part of CEHRT EPs can better ensure 

that electronic messages are sent 

securely to protect patient’s health 

information. Finally, we are concerned 

that CEHRT would not be able to track 

electronic messaging that is not part of 

the EHR, which would place an extra 

burden for reporting on EPs in meeting 

this measure. For all of these reasons, 

we require that patients use the 

electronic messaging function that is 

part of CEHRT in order to be included 

in the measure of this objective. 

Comment: Commenters agreed with 

our decision not to include in the 

definition for this measure ‘‘relevant 

health information.’’ Commenters did 

not believe CEHRT could support the 

categorization of electronic messages in 

a way that would satisfy such a 

requirement. 

Response: We appreciate the support 

offered by commenters. As we stated in 

the proposed rule, the secure messages 

sent should contain relevant health 

information specific to the patient in 

order to meet the measure of this 

objective. We believe the EP is the best 

judge of what health information should 

be considered relevant in this context. 

We do not specifically include the term 

‘‘relevant health information’’ in the 

measure because we believe the 

provider is best equipped to determine 

whether such information is included. 

We agree that it would be too great a 

burden for CEHRT to determine whether 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54033 

the information in the secure message 

has such information. 

Comment: Some commenters 

expressed concerns that we did not 

propose to measure provider response to 

patient electronic messaging. These 

commenters believed that the proposed 

measure places too much focus on 

patient messaging and should instead 

focus on communication between 

patient and provider. Some commenters 

suggested that the measure be modified 

for responsiveness of an EP or staff to 

patient messaging rather than the 

proposed percentage of patients who 

send a secure message. 

Response: As we stated in the 

proposed rule, there is an expectation 

that the EP would respond to electronic 

messages sent by the patient, although 

we do not specify the method of 

response or require the EP to document 

his or her response for this measure. We 

decline to specify the method of 

provider response because we believe it 

is best left to the provider’s clinical 

judgment to decide the course of action 

which should be taken in response to 

the patient’s electronic message. An EP 

or staff member could decide that a 

follow-up telephone call or office visit 

is more appropriate to address the 

concerns raised in the electronic 

message. Therefore, we decline to alter 

the measure to include provider 

response. 

Comment: Commenters asked for 

clarification as to whether the EP had to 

respond personally to electronic 

messaging or whether members of the 

EP’s staff could respond. Commenters 

also asked for clarification regarding 

whether or not messages sent by a 

patient-authorized representative would 

be recorded in this measure. 

Response: There is not an expectation 

that the EP must personally respond to 

electronic messages to the patient. Just 

as an EP’s staff respond to telephone 

inquiries or conduct office visits on 

behalf of the EP, staff could also 

respond to electronic messages from the 

patient. We also intend for electronic 

messages sent by a patient-authorized 

representative to be included in the 

measure of this objective and have 

modified the language of the measure 

below accordingly. 

Comment: Some commenters raised 

concerns regarding the security of 

electronic messaging, specifically citing 

instances where family members might 

have access to the patient’s account or 

elderly patients who would not know 

how to use a computer and would have 

to give account access to a caregiver. 

Other commenters raised concerns 

regarding their liability in providing 

access to such information or in 

responding to an electronic message. 

Response: We do not believe that 

secure electronic messaging poses 

greater risks to exposure of protected 

health information than other mediums 

such as telephone messaging, paper 

records, etc. In some cases secure 

electronic messaging can provide even 

greater protection of health information. 

We note that many patients grant access 

to health information to family members 

and caregivers to facilitate care, and we 

expect the same access to continue with 

secure electronic messaging. Nor do we 

believe that secure electronic messaging 

exposes providers to greater liability (for 

example, in areas of privacy protection 

or malpractice) than other mediums 

such as telephone, mail, paper records, 

etc. Previous research has demonstrated 

that better patient-provider 

communication reduces the likelihood 

of malpractice claims being filed. 

Comment: Some commenters noted 

that the potential financial burden of 

implementing securing messaging as a 

part of their clinical or administrative 

workflow. These commenters noted that 

EPs are not reimbursed for the time 

spent responding to electronic messages 

and that it can be time consuming for an 

EP to have multiple exchanges with a 

patient via email. 

Response: We do not believe that 

implementing electronic messaging 

imposes a significant burden on 

providers. While we note that in some 

scenarios it may be possible for an EP 

to receive reimbursement from private 

insurance payers for online messaging, 

we acknowledge that EPs are generally 

not reimbursed for time spent 

responding to electronic messaging. 

However, it is also true that EPs are 

generally not reimbursed for other 

widely used methods of communication 

with patients (for example, telephone). 

As we noted in the proposed rule, many 

providers have seen a reduction in time 

responding to inquires and less time 

spent on the phone through the use of 

electronic messaging. In addition, we 

note that EPs themselves do not have to 

respond to electronic messages 

personally and can delegate this task to 

staff, just as many EPs currently 

delegate telephone exchanges with 

patients to staff. 

After consideration of the public 

comments, we are finalizing the 

meaningful use measure for EPs as ‘‘A 

secure message was sent using the 

electronic messaging function of CEHRT 

by more than 5 percent of unique 

patients (or their authorized 

representatives) seen by the EP during 

the EHR reporting period’’ at 

§ 495.6(j)(17)(ii) and the exclusion for 

EPs as ‘‘Any EP who has no office visits 

during the EHR reporting period, or any 

EP who conducts 50 percent or more of 

his or her patient encounters in a county 

that does not have 50 percent or more 

of its housing units with 3Mbps 

broadband availability according to the 

latest information available from the 

FCC on the first day of the EHR 

reporting period’’ at § 495.6(j)(17)(iii). 

We further specify that in order to 

meet this objective and measure, an EP 

must use the capabilities and standards 

of CEHRT at 45 CFR 170.314(e)(3). 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of unique 

patients seen by the EP during the EHR 

reporting period. 

• Numerator: The number of patients 

or patient-authorized representatives in 

the denominator who send a secure 

electronic message to the EP that is 

received using the electronic messaging 

function of CEHRT during the EHR 

reporting period. 

• Threshold: The resulting percentage 

must be more than 5 percent in order for 

an EP to meet this measure. 

• Exclusion: Any EP who has no 

office visits during the EHR reporting 

period, or any EP who conducts 50 

percent or more of his or her patient 

encounters in a county that does not 

have 50 percent or more of its housing 

units with 3Mbps broadband 

availability according to the latest 

information available from the FCC on 

the first day of the EHR reporting 

period. 

Proposed Eligible Hospital/CAH 

Objective: Automatically track 

medications from order to 

administration using assistive 

technologies in conjunction with an 

electronic medication administration 

record (eMAR). 

In the proposed rule, we outlined the 

following benefits of automatically 

tracking medications with eMAR: eMAR 

increases the accuracy of medication 

administration thereby increasing both 

patient safety and efficiency. The HIT 

Policy Committee has recommended the 

inclusion of this objective for hospitals 

in Stage 2, and we proposed this as a 

core objective for eligible hospitals and 

CAHs. The additional time made 

available for Stage 2 implementation 

makes possible the inclusion of some 

new objectives in the core set. eMAR is 

critically important to making care safer 

by reducing medication errors which 

may make care more affordable. eMAR 

has been shown to lead to significant 

improvements in medication-related 

adverse events within hospitals with 

associated decreases in cost. eMAR cuts 

mstockstill on DSK4VPTVN1PROD with RULES2

54034 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

in half the adverse drug event (ADE) 

rates for non-timing medication errors, 

according to a study published in the 

New England Journal of Medicine (Poon 

et al., 2010, Effect of Bar-Code 

Technology on the Safety of Medication 

Administration http://www.nejm.org/ 

doi/abs/10.1056/ 

NEJMsa0907115?query=NC). A study 

done to evaluate cost-benefit of eMAR 

(Maviglia et al., 2007, Cost-Benefit 

Analysis of a Hospital Pharmacy Bar 

Code Solution http://archinte.amaassn.org/cgi/content/full/167/8/788) 

demonstrated that associated ADE cost 

savings allowed hospitals to break even 

after 1 year and begin reaping cost 

savings going forward. 

We proposed to define eMAR as 

technology that automatically 

documents the administration of 

medication into CEHRT using electronic 

tracking sensors (for example, radio 

frequency identification (RFID)) or 

electronically readable tagging such as 

bar coding). The specific characteristics 

of eMAR for the EHR Incentive 

Programs will be further described in 

the ONC standards and certification 

criteria final rule published elsewhere 

in this issue of the Federal Register. 

By its very definition, eMAR occurs at 

the point of care so we did not propose 

additional qualifications on when it 

must be used or who must use it. 

Comment: Some commenters 

suggested that this should be a menu 

objective for Stage 2. 

Response: As we stated in the 

proposed rule, we believe that eMAR is 

critically important to making care safer 

by reducing medication errors which 

may also make care more affordable. 

eMAR has been shown to lead to 

significant improvements in 

medication-related adverse events 

within hospitals with associated 

decreases in cost. Therefore, we believe 

that the benefits to patient safety from 

eMAR warrant the inclusion of this as 

a Stage 2 core objective for eligible 

hospitals and CAHs. 

After consideration of the public 

comments, we are finalizing the 

meaningful use objective for eligible 

hospitals and CAHs at § 495.6(l)(16)(i) 

as proposed. 

Proposed Eligible Hospital/CAH 

Measure: More than 10 percent of 

medication orders created by authorized 

providers of the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period are tracked using 

eMAR. 

Comment: A number of commenters 

questioned whether the measure should 

apply to at least one instance of the 

administration of a dose connected with 

a medication order or whether each 

individual dose connected with a 

medication order should be included in 

the measure. Some commenters 

believed that a single instance of 

administration of a dose should 

constitute fulfillment of the measure, 

while others believed that all doses 

administered rather than orders 

administered would be a more precise 

and meaningful measurement. 

Response: We believe that including 

each individual dose connected with a 

medication order through this measure 

could yield denominators that are very 

large. However, we believe that the 

benefits to patient safety from eMAR are 

seen when all doses of a medication 

order are tracked. Therefore, we clarify 

that we include in the numerator of this 

objective medication orders for which 

all doses are tracked using eMAR, and 

we are amending the measure language 

below to reflect this clarification. If a 

medication is ordered but not all doses 

of the medication are tracked using 

eMAR, then that order may not be 

included in the numerator of the 

measure. 

Comment: Some commenters raised 

the concern that certain rural and low 

volume hospitals might face undue 

financial burden in implementing this 

objective and proposed an exclusion for 

hospitals with either a limited number 

of inpatient beds or a low average 

inpatient volume. Some commenters 

suggested there should be an exclusion 

for very small hospitals for whom eMAR 

could be a prohibitively expensive 

undertaking. Other commenters noted 

that the difficulties in implementing 

eMAR were outweighed by the 

significant benefits to patient safety. 

Response: We agree with commenters 

who suggested that the potential 

benefits to patient safety of eMAR are 

significant. While we agree that certain 

hospitals may face challenges in 

implementing eMAR on a wider scale, 

we believe that the low threshold for 

this measure lessens the burden 

associated with implementation of 

eMAR for most rural and low volume 

hospitals. We also note that CEHRT will 

include eMAR capabilities, so the 

primary barrier to implementation for 

most hospitals will be workflow. 

However, we are also concerned that 

very small hospitals may have local 

technical support and training issues 

that may make an automated eMAR 

solution actually less effective than 

other approaches. We also believe that 

very small hospitals will have fewer 

health care professionals involved in the 

process of medication administration 

and fewer patients for whom 

duplicative orders could present an 

issue, which would also make an eMAR 

solution less effective. Therefore, we 

believe these hospitals would not 

benefit from eMAR as much as larger 

facilities and are finalizing an exclusion 

for these hospitals. Any hospital with an 

average daily inpatient census of fewer 

than 10 patients may be excluded from 

meeting the measure of this objective. 

For purposes of this exclusion, we 

define an average daily inpatient census 

as the total number of patients admitted 

during the previous calendar year 

divided by 365 (or 366 if the previous 

calendar year is a leap year). 

Comment: Some commenters stated 

that the percentage threshold of this 

measure should be replaced with the 

implementation of eMAR in one ward or 

unit of the hospital to limit burdensome 

measurement requirements. Other 

commenters argued that changing the 

measure to one ward or unit of the 

hospital would introduce ambiguity 

regarding what constitutes a ward or 

unit, while a percentage threshold 

would allow hospitals the flexibility to 

implement eMAR capabilities on a 

limited basis. 

Response: We believe that the low 

threshold of this objective does not 

impose burdensome measurement 

requirements on hospitals, especially 

since we do not anticipate a significant 

difference in the way CEHRT will 

measure eMAR usage regardless of 

where it is implemented. We agree that 

limiting the measure to implementation 

in a single ward or unit could introduce 

ambiguity regarding the precise 

definition of ward or unit, especially 

since some hospitals combine the 

locations and workflows of certain 

units. We further note that the 

percentage threshold does allow 

hospitals to implement eMAR in a 

limited capacity, and that a hospital 

could potentially meet the low measure 

of this objective by implementing in a 

single ward or unit or by implementing 

in several smaller wards or units that 

combine to yield more than 10 percent 

of medication orders created during the 

EHR reporting period. We believe the 

percentage measure of this objective 

yields maximum flexibility for a 

hospital to implement eMAR in a way 

that is clinically relevant to its 

individual workflow. 

Comment: Some commenters 

requested clarification on whether 

eMAR could be implemented solely in 

portions of an inpatient department or 

solely in portions of an emergency 

department in order to meet the 

measure, as opposed to implementing 

eMAR in both the inpatient and 

emergency departments. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54035 

Response: As stated previously, we 

have attempted to provide maximum 

flexibility for a hospital to implement 

eMAR in a way that is clinically 

relevant to its individual workflow. 

Therefore, we do not require that eMAR 

is implemented in both inpatient and 

emergency departments in order to meet 

this measure, only that more than 10 

percent of medication orders created by 

authorized providers of either the 

inpatient or emergency department 

(POS 21 or 23) during the EHR reporting 

period are tracked using eMAR. 

Hospitals could implement eMAR in the 

inpatient department, the emergency 

department, or both departments in 

order to meet the threshold of this 

measure. 

After consideration of the public 

comments, we modify the meaningful 

use measure as ‘‘More than 10 percent 

of medication orders created by 

authorized providers of the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period for 

which all doses are tracked using 

eMAR’’ for eligible hospitals and CAHs 

at § 495.6(l)(16)(ii) and finalize the 

exclusion as ‘‘Any eligible hospital or 

CAH with an average daily inpatient 

census of fewer than 10 patients’’ at 

§ 495.6(l)(16)(iii). 

We further specify that in order to 

meet this objective and measure, an 

eligible hospital or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(a)(16). 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of 

medication orders created by authorized 

providers in the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period. 

• Numerator: The number of orders 

in the denominator for which all doses 

are tracked using eMAR. 

• Threshold: The resulting percentage 

must be more than 10 percent in order 

for an eligible hospital or CAH to meet 

this measure. 

• Exclusion: Any hospital with an 

average daily inpatient census of fewer 

than ten (10) patients. 

Proposed Eligible Hospital/CAH 

Objective: Generate and transmit 

permissible discharge prescriptions 

electronically (eRx) 

In the proposed rule, we outlined the 

following benefits of electronic 

prescribing: The use of electronic 

prescribing has several advantages over 

having the patient carry the prescription 

to the pharmacy or directly faxing a 

handwritten or typewritten prescription 

to the pharmacy. When the hospital 

generates the prescription 

electronically, CEHRT can recognize the 

information and can provide decision 

support to promote safety and quality in 

the form of adverse interactions and 

other treatment possibilities. The 

CEHRT can also provide decision 

support that promotes the efficiency of 

the health care system by alerting the EP 

to generic alternatives or to alternatives 

favored by the patient’s insurance plan 

that are equally effective. Transmitting 

the prescription electronically promotes 

efficiency and safety through reduced 

communication errors. It also allows the 

pharmacy or a third party to 

automatically compare the medication 

order to others they have received for 

the patient. This comparison allows for 

many of the same decision support 

functions enabled at the generation of 

the prescription, but bases them on 

potentially greater information. 

We have combined the comments and 

responses for this objective with the 

measure below. After consideration of 

the public comments, we are finalizing 

the meaningful use objective for eligible 

hospitals and CAHs at § 495.6(m)(4)(i) 

as proposed. 

Proposed Eligible Hospital/CAH 

Measure: More than 10 percent of 

hospital discharge medication orders for 

permissible prescriptions (for new or 

changed prescriptions) are compared to 

at least one drug formulary and 

transmitted electronically using CEHRT. 

Comment: Most commenters voiced 

support for this as a menu set item, with 

some commenters noting that the 

threshold for this measure should 

remain low for Stage 2 because of the 

difficulty of using electronic prescribing 

for all prescriptions, including 

controlled substances. 

Response: We appreciate the support 

for this objective, and we note that the 

measure of the objective for eligible 

hospitals and CAHs for Stage 2 is set at 

more than 10 percent of all discharge 

medication orders for permissible 

prescriptions. We believe this sets a 

sufficiently low threshold that would 

allow most hospitals to achieve this 

measure and eliminates the inclusion of 

controlled substances, which are not 

included as permissible prescriptions 

for the purposes of this measure. 

Comment: Most commenters noted 

that distinguishing new and altered 

prescriptions from refills would be 

unnecessarily burdensome for hospitals. 

Response: Although we had initially 

proposed to limit this measure to only 

new and altered prescriptions because 

we believed that hospitals would not 

issue refill prescriptions, we agree with 

the commenters that distinguishing 

refills from new and altered 

prescriptions could be unnecessarily 

burdensome for hospitals. Therefore, we 

are not imposing this limitation and 

include new, altered, and refill 

prescriptions in the measure of 

discharge medication orders for 

permissible prescriptions. 

Comment: Some commenters 

expressed concerns about patient 

requests for paper prescriptions instead 

of electronic prescriptions. 

Response: We believe that the more 

than 10 percent of discharge medication 

orders threshold is sufficiently low to 

accommodate patient requests for paper 

prescriptions and still allow most, if not 

all, hospitals to meet the measure of this 

objective. 

Comment: Some commenters asked 

whether prescriptions electronically 

transmitted to in-house pharmacies 

should be included in the measure and 

if the standards specified by ONC for 

this measure would apply to these 

transmissions. 

Response: We are continuing the 

policy from Stage 1 that prescriptions 

transmitted electronically within an 

organization (the same legal entity) 

would be counted in the measure and 

would not need to use the standards 

specified by ONC for this objective. 

However, a hospital’s CEHRT must meet 

all applicable certification criteria and 

be certified as having the capability of 

meeting external transmission 

requirements. In addition, the EHR that 

is used to transmit prescriptions within 

the organization would need to be 

CEHRT. 

The hospital would include in the 

numerator and denominator both types 

of electronic transmission (those within 

and outside the organization) for the 

measure of this objective. We further 

clarify that for purposes of counting 

discharge prescriptions ‘‘generated and 

transmitted electronically,’’ we 

considered the generation and 

transmission of prescriptions to occur 

simultaneously if the prescriber and 

dispenser are the same person and/or 

are accessing the same record in an 

integrated EHR to create an order in a 

system that is electronically transmitted 

to an internal pharmacy. 

Comment: Some commenters asked 

for clarification regarding whether drugformulary checks had to be enabled for 

the entire EHR reporting period, as 

required by the Stage 1 measure. 

Response: No. The Stage 1 objective 

for drug-formulary checks has been 

combined with this Stage 2 objective for 

generating and transmitting permissible 

discharge prescriptions electronically. 

Although the measure of the Stage 1 

objective required the capability for 

mstockstill on DSK4VPTVN1PROD with RULES2

54036 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

5 Ibid. 

drug-formulary checks to be enabled for 

the entire reporting period, the measure 

of the Stage 2 objective specifies drugformulary checks should be performed 

for more than 10 percent of hospital 

discharge medication orders for 

permissible prescriptions. We recognize 

that not every patient will have a 

formulary that is relevant for him or her. 

Therefore, we require not that the EHR 

check each prescription against a 

formulary relevant for a given patient, 

but rather that the EHR check each 

prescription for the existence of a 

relevant formulary. If a relevant 

formulary is available, then the 

information can be provided. We 

believe that this initial check is 

essentially an on or off function for the 

EHR and should not add to the 

measurement burden. Therefore, with 

this clarification of the check we are 

referring to, we are finalizing the drug 

formulary check as a component of this 

measure. We look forward to the day 

when a relevant formulary is available 

for every patient. We modified the 

measure to use the word query instead 

of compare. 

Comment: Some commenters asked 

whether the measure of this objective 

applied to inpatient departments, 

emergency departments, or both. 

Response: We specify that the 

measure of this objective applies to 

medication orders for patients 

discharged from either the inpatient 

(POS 21) department, the emergency 

department, or both the inpatient and 

emergency departments of an eligible 

hospital or CAH during the EHR 

reporting period. 

Comment: One commenter asked for 

clarification of whether a patient for 

whom no relevant drug formularies are 

available could be counted in the 

numerator of the measure if the 

discharge prescription for that patient is 

generated and transmitted 

electronically. Another commenter 

suggested that patients for whom no 

relevant formularies are available 

should not be counted in the measure. 

Response: As noted in the proposed 

rule, we believe that the inclusion of the 

comparison to at least one drug 

formulary enhances the efficiency of the 

healthcare system when clinically 

appropriate and cheaper alternatives 

may be available. In the event that a 

relevant formulary is unavailable for a 

particular patient and medication 

combination, a discharge prescription 

that is generated and electronically 

transmitted should still be included in 

the numerator of the measure. We do 

not agree that prescriptions for patients 

for whom relevant formularies are 

unavailable should be excluded from 

this measure. 

Comment: Several commenters 

believed that the exclusion based on the 

availability of a pharmacy capable of 

receiving electronic prescriptions 

within 25 miles of the hospital’s 

location was not adequate for all areas, 

particularly rural areas. Some 

commenters suggested that 10 miles is 

a more appropriate distance. 

Response: We appreciate the 

commenters’ concerns about this 

exclusion. As stated in the proposed 

rule, we recognize that certain areas 

may not have widespread availability of 

electronic prescribing in all pharmacies, 

we believe that most hospitals will be 

able to fulfill electronic prescriptions 

through an internal pharmacy. However, 

we agree with commenters that basing 

the exclusion on a 25-mile radius could 

place a significant burden on patients to 

travel to fill prescriptions, especially in 

rural areas. Therefore, we are finalizing 

a 10-mile radius at the start of the EHR 

reporting period. Hospitals that do not 

have an internal pharmacy and that are 

located 10 miles from a pharmacy that 

can receive electronic prescriptions at 

the start of the EHR reporting period 

would be able to claim the exclusion for 

this measure. We also believe that the 

low threshold of more than 10 percent 

of discharge prescriptions transmitted 

electronically would make it possible 

for all hospitals to meet this measure. 

Comment: Some commenters 

requested for clarification of whether 

CEHRT would provide the capability to 

determine the availability of a pharmacy 

capable of receiving electronic 

prescriptions within 25 miles of the 

hospital’s location. 

Response: CEHRT will not provide 

the capability to determine whether a 

hospital meets the exclusion for this 

measure. As stated in the previous 

response, we are finalizing the 

exclusion for the availability of a 

pharmacy capable of receiving 

electronic prescriptions within 10 miles 

of the hospital’s location. Therefore, 

eligible hospitals and CAHs may use 

their own resources to make a 

determination regarding the availability 

of a pharmacy capable of receiving 

electronic prescriptions within 10 miles 

of the hospital’s location. 

After consideration of the public 

comments, we modify the meaningful 

use measure for eligible hospitals and 

CAHs as ‘‘More than 10 percent of 

hospital discharge medication orders for 

permissible prescriptions (for new, 

changed, and refilled prescriptions) are 

queried for a drug formulary and 

transmitted electronically using 

CEHRT’’ at § 495.6(m)(4)(ii) and we 

modify the exclusion for eligible 

hospitals and CAHs at § 495.6(m)(4)(iii) 

by changing the radius from 25 miles to 

10 miles. 

We further specify that in order to 

meet this objective and measure, an 

eligible hospital or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(a)(10) and (b)(3). 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of new, 

changed, or refill prescriptions written 

for drugs requiring a prescription in 

order to be dispensed other than 

controlled substances for patients 

discharged during the EHR reporting 

period. 

• Numerator: The number of 

prescriptions in the denominator 

generated, queried for a drug formulary 

and transmitted electronically. 

• Threshold: The resulting percentage 

must be more than 10 percent in order 

for an eligible hospital or CAH to meet 

this measure. 

• Exclusion: Any eligible hospital or 

CAH that does not have an internal 

pharmacy that can accept electronic 

prescriptions and is not located within 

10 miles of any pharmacy that accepts 

electronic prescriptions at the start of 

their EHR reporting period. 

Proposed Eligible Hospital/CAH 

Objective: Provide patients the ability to 

view online, download, and transmit 

information about a hospital admission. 

In the proposed rule, we noted that 

studies have found that patients 

engaged with computer based 

information sources and decision 

support show improvement in quality of 

life indicators, patient satisfaction and 

health outcomes. (Ralston, Carrell, Reid, 

Anderson, Moran, & Hereford, 2007) 

(Gustafson, Hawkins, Bober, S, 

Graziano, & CL, 1999) (Riggio, Sorokin, 

Moxey, Mather, Gould, & Kane, 2009) 

(Gustafson, et al., 2001). In addition, we 

noted that this objective aligns with the 

FIPPs,5 in affording baseline privacy 

protections to individuals. We stated 

that we believe this information is 

integral to the Partnership for Patents 

initiative and reducing hospital 

readmissions. While this objective does 

not require all of the information 

sources and decision support used in 

these studies, having a set of basic 

information available advances these 

initiatives. The ability to have this 

information online means it is always 

retrievable by the patient, while the 

download function ensures that the 

patient can take the information with 

them when secure internet access is not 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54037 

available. However, providers should be 

aware that while meaningful use is 

limited to the capabilities of CEHRT to 

provide online access, there may be 

patients who cannot access their EHRs 

electronically because of their disability. 

Additionally, other health information 

may not be accessible. Finally, we noted 

that providers who are covered by civil 

rights laws must provide individuals 

with disabilities equal access to 

information and appropriate auxiliary 

aids and services as provided in the 

applicable statutes and regulations. 

We proposed this as a core objective 

for hospitals for Stage 2. We also 

specified in the proposed rule the 

information that must be made available 

as part of the objective, although we 

noted hospitals could choose to provide 

additional information (77 FR 13730). 

Comment: Some commenters 

suggested that this objective should be 

part of the menu set instead of a core 

objective for Stage 2. This would permit 

eligible hospitals and CAHs that do not 

believe they can meet the measure at 

this time to select different objectives. 

Response: We do not agree that this 

objective should be part of the menu set. 

We proposed this objective as part of the 

core for eligible hospitals and CAHs 

because it is intended to replace the 

previous Stage 1 core objective of 

‘‘Provide patients with an electronic 

copy of their health information upon 

request’’ and the Stage 1 core objective 

of ‘‘Provide patients with an electronic 

copy of their discharge information.’’ 

Although CEHRT will provide added 

capabilities for this objective, we do not 

believe the objective itself is sufficiently 

different from previous objectives to 

justify placing it in the menu set. Also, 

we believe that patient access to their 

discharge information is a high priority 

for the EHR Incentive Programs and this 

objective best provides that access in a 

timely manner. 

Comment: Some commenters 

expressed the opinion that this objective 

should not be included as part of 

meaningful use and was more 

appropriately regulated under HIPAA 

and through the Office for Civil Rights. 

Response: We do not agree that this 

objective should not be included in 

meaningful use. Although we recognize 

that many issues concerning the privacy 

and security of information online are 

subject to HIPAA requirements, we 

believe that establishing an objective to 

provide online access to health 

information is within the regulatory 

purview of the EHR Incentive Programs 

and consistent with the statutory 

requirements of meaningful use. 

After consideration of the public 

comments, we are finalizing the 

meaningful use objective for eligible 

hospitals and CAHs at § 495.6(l)(8)(i) as 

proposed. 

Proposed Eligible Hospital/CAH 

Measure: There are 2 measures for this 

objective, both of which must be 

satisfied in order to meet the objective. 

More than 50 percent of all patients 

who are discharged from the inpatient 

or emergency department (POS 21 or 23) 

of an eligible hospital or CAH have their 

information available online within 36 

hours of discharge. 

More than 10 percent of all patients 

who are discharged from the inpatient 

or emergency department (POS 21 or 23) 

of an eligible hospital or CAH view, 

download or transmit to a third party 

their information during the EHR 

reporting period. 

Comment: A commenter questioned 

how long data should be made available 

online before it can be removed. 

Response: It is the goal of this 

objective to make available to the 

patient both current and historical 

health information regarding hospital 

discharges. Therefore, we would 

anticipate that the data should be 

available online on an ongoing basis. 

However, an eligible hospital or CAH 

may withhold or remove information 

from online access for purposes of 

meaningful use if they believe 

substantial harm may arise from its 

disclosure online. 

Comment: Some commenters asked 

for clarification on whether online 

access had to be made available using 

CEHRT or if the information could be 

made available through other means 

(patient portal, PHR, etc.). 

Response: Both of the measures for 

this objective must be met using 

CEHRT. Therefore, for the purposes of 

meeting this objective, the capabilities 

provided by a patient portal, PHR, or 

any other means of online access and 

that would permit a patient or 

authorized representative to view, 

download, or transmit their personal 

health information would have to be 

certified in accordance with the 

certification requirements adopted by 

ONC. We refer readers to ONC’s 

standards and certification criteria final 

rule that is published elsewhere in this 

issue of the Federal Register. 

Comment: Some commenters asked 

for clarification on how access by the 

patient is defined. 

Response: We define access as having 

been given when the patient possesses 

all of the necessary information needed 

to view, download, or transmit their 

discharge information. This could 

include providing patients with 

instructions on how to access their 

health information, the Web site address 

they must visit for online access, a 

unique and registered username or 

password, instructions on how to create 

a login, or any other instructions, tools, 

or materials that patients need in order 

to view, download, or transmit their 

discharge information. 

Comment: Some commenters 

suggested that patients under the age of 

18 should not have the same access to 

the same information to which adult 

patients have access and requested a 

separate list of required elements for 

patients under the age of 18. 

Response: An eligible hospital or CAH 

may decide that online access is not the 

appropriate forum for certain health 

information for patients under the age of 

18. Within the confines of the laws 

governing guardian access to medical 

records for patients under the age of 18, 

we would defer to the eligible hospital’s 

or CAH’s judgment regarding which 

information should be withheld for such 

patients. In lieu of providing online 

access to patients under the age of 18, 

eligible hospitals or CAHs could 

provide online access to guardians for 

patients under the age of 18, in 

accordance with state and local laws, in 

order to meet the measure of this 

objective. Providing online access to 

guardians in accordance to state and 

local laws would be treated the same as 

access for patients, and guardians could 

then be counted in the numerator of the 

measure. We recognize that state and 

local laws may restrict the information 

that can be made available to guardians, 

and in these cases such information can 

be withheld and the patient could still 

be counted in the numerator of the 

measure. 

Comment: Many commenters voiced 

objections to the second measure of this 

objective and the concept of providers 

being held accountable for patient 

actions. The commenters believed that 

while providers could be held 

accountable for making information 

available online to patients, providers 

could not control whether patients 

actually accessed their information. 

Many commenters also noted that the 

potential barriers of limited internet 

access, computer access, and patient 

engagement with health IT for certain 

populations (for example, rural, elderly, 

lower income, non-English-speaking, 

etc.) might make the measure 

impossible to meet for some providers. 

There were also a number of comments 

stating that metrics used to track views 

or downloads can be misleading and are 

not necessarily the most accurate 

measure of patient usage. Commenters 

suggested a number of possible 

solutions to allow providers to 

overcome these barriers, including 

mstockstill on DSK4VPTVN1PROD with RULES2

54038 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

eliminating the percentage threshold of 

the measure or requiring providers to 

offer and track patient access but not 

requiring them to meet a percentage 

measure in order to demonstrate 

meaningful use. However, some 

commenters believed that the measure 

was a reasonable and necessary step to 

ensure that providers had accountability 

for engagement of their patients in use 

of electronic health information and 

integration of it into clinical practice. In 

addition, commenters pointed to the 

unique role that providers can play in 

encouraging and facilitating their 

patients’ and their families’ use of 

online tools. 

Response: While we recognize that 

eligible hospitals and CAHs cannot 

directly control whether patients access 

their health information online, we 

continue to believe that eligible 

hospitals and CAHs are in a unique 

position to strongly influence the 

technologies patients use to improve 

their own care, including viewing, 

downloading, and transmitting their 

health information online. We believe 

that the eligible hospital’s or CAH’s 

ability to influence patients coupled 

with the low threshold of more than 10 

percent of patients who view online, 

download, or transmit to a third party 

their information make this measure 

achievable for all eligible hospitals and 

CAHs. 

We recognize that certain patient 

populations face greater challenges in 

online access to information. We 

address the potential barrier of limited 

internet access in the comment 

regarding a broadband exclusion below. 

We address the potential barrier to 

individuals with disabilities through 

ONC’s rules requiring that EHRs meet 

disability accessibility standards. While 

we agree that excluding certain patient 

populations from this requirement 

would make the measure easier for 

eligible hospitals and CAHs to achieve, 

we do not know of any reliable method 

to quantify these populations for each 

eligible hospital and CAH in such a way 

that we could standardize exclusions for 

each population. We also decline to 

eliminate the percentage threshold of 

this measure because we do not believe 

that a simple yes/no attestation for this 

objective is adequate to encourage a 

minimum level of patient usage. 

However, in considering the potential 

barriers faced by these patient 

populations, we agree that it would be 

appropriate to lower the proposed 

threshold of this measure to more than 

5 percent of unique patients who view 

online, download, or transmit to a third 

party their information. In addition, we 

are concerned that blanket exclusions 

for certain disadvantaged populations 

could serve to extend existing 

disparities in electronic access to 

information and violate civil rights 

laws. All entities receiving funds under 

this program are subject to civil rights 

laws. For more information about these 

laws and their requirements (see 

http://www.hhs.gov/ocr/civilrights/ 

index.html). We believe that this lower 

threshold, combined with the 

broadband exclusion detailed in the 

response later in this section, will allow 

all eligible hospitals and CAHs to meet 

the measure of this objective. 

Comment: Some commenters 

suggested making the numerator and 

denominator language for this measure 

consistent with the language used for 

this measure for EPs. 

Response: We agree that there are 

some slight variations in language 

between the measure for EPs and the 

measure for hospitals. To the extent 

possible, we have harmonized the 

language between both. 

Comment: Some commenters asked 

for clarification on how view is defined. 

Response: We define view as the 

patient (or authorized representative) 

accessing their health information 

online. 

Comment: Some commenters noted 

that the potential financial burden of 

implementing an online patient portal 

to provide patients online access to 

discharge information. These 

commenters noted the added time 

burden for staff in handling the 

additional patient use of online 

resources, which may increase costs 

through the hiring of additional staff, as 

well as the need to modify their existing 

workflow to accommodate potential 

online messages from patients. Some 

commenters also believed that there 

would be an additional cost for sharing 

content before standards exist for 

content types and formats. 

Response: As noted in the proposed 

rule, studies have found that patients 

engaged with computer based 

information sources and decision 

support show improvement in quality of 

life indicators, patient satisfaction and 

health outcomes (see Rosenberg SN, 

Shnaiden TL, Wegh AA, Juster IA (2008) 

‘‘Supporting the patient’s role in 

guideline compliance: a controlled 

study’’ American Journal of Managed 

Care 14(11):737–44; Gustafson DH, 

Hawkins R, Boberg E, Pingree S, Serlin 

RE, Graziano F, Chan CL (1999) ‘‘Impact 

of a patient-centered, computer-based 

health information/support system’’ 

American Journal of Preventive 

Medicine 16(1):1–9; Ralston JD, Carrell 

D, Reid R, Anderson M, Moran M, 

Hereford J (2007) ‘‘Patient web services 

integrated with a shared medical record: 

patient use and satisfaction’’ Journal of 

the American Medical Informatics 

Association 14(6):798–806). We believe 

that the information provided as part of 

this measure is integral to the 

Partnership for Patents initiative and 

reducing hospital readmissions. We do 

not believe that implementing online 

access for patients imposes a significant 

burden, financial or otherwise, on 

providers. While we note that in some 

scenarios it may be possible for an 

eligible hospital or CAH to receive 

reimbursement from private insurance 

payers for online messaging, we 

acknowledge that eligible hospitals and 

CAHs are generally not reimbursed for 

time spent responding to electronic 

messaging. However, it is also true that 

eligible hospitals and CAHs are 

generally not reimbursed for other 

widely used methods of communication 

with patients (for example, telephone). 

In addition, it will be part of the 

capability of CEHRT to automatically 

populate most of the list of required 

elements to meet this measure, which 

significantly reduces the administrative 

burden of providing this information. 

Finally, we believe that the standards 

established for this objective by ONC 

will serve as a content standard that will 

allow this information to be more easily 

transmitted and uploaded to another 

certified EHR, thereby reducing the cost 

of sharing information. 

Comment: Some commenters noted 

that patient engagement could occur 

effectively with or without online 

access, and patients should be 

encouraged to use any method (for 

example, telephone, internet, traditional 

mail) that suits them. These commenters 

noted that engagement offline reduces 

both the need and value for engagement 

online. 

Response: We agree that patient 

engagement can occur effectively 

through a variety of media, and we also 

believe that electronic access to 

discharge information can be an 

important component of patient 

compliance and improving longitudinal 

care. We do not believe that offline 

engagement reduces the need for online 

access, as patients may opt to access 

information in a variety of ways. 

Because of the variety of ways that 

patients/families may access 

information, we keep the threshold for 

this measure low. Measuring other 

means of accessing health information is 

beyond the scope of the EHR Incentive 

Programs. We also note that online 

access to health information can 

enhance offline engagement—for 

example, patients could download 

information from a hospital admission 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54039 

to bring with them for a consult on 

follow-up care—which is one of the 

primary goals of the EHR Incentive 

Programs. 

Comment: Some commenters 

expressed concern that vendors would 

not be able to make these capabilities 

available as part of CEHRT in time for 

the beginning of Stage 2. 

Response: Many CEHRT vendors 

already make patient portals available 

that would meet the certification criteria 

and standards required for this measure. 

Although the Stage 2 eligible hospital/ 

CAH measure requires some additional 

required elements and fields 

capabilities, we believe vendors will be 

able to make these capabilities available 

in time for the beginning of Stage 2. 

Comment: Some commenters 

suggested that basing the exclusion on 

the broadband data available from the 

FCC Web site (www.broadband.gov) was 

suspect since the data originates from 

vendors. 

Response: The broadband data made 

available from the FCC was collected 

from over 3,400 broadband providers 

nationwide. This data was then subject 

to many different types of analysis and 

verification methods, from drive testing 

wireless broadband service across their 

highways to meeting with community 

leaders to receive feedback. 

Representatives met with broadband 

providers, large and small, to confirm 

data, or suggest changes to service areas, 

and also went into the field looking for 

infrastructure to validate service 

offerings in areas where more 

information was needed. Therefore, we 

believe the data is appropriate for the 

exclusion to this measure. We note that 

since publication of our proposed rule 

the Web site has changed to 

www.broadbandmap.gov and the speed 

used has changed from 4Mbps to 

3Mbps. We are updating our exclusion 

to reflect these changes. 

Comment: Some commenters believe 

that broadband exclusions should be 

based on the patients’ locations instead 

of the providers, since county-level data 

may not be granular enough to capture 

all areas of low broadband availability 

within a particular region. 

Response: Although we agree that a 

broadband exclusion based primarily on 

the individual locations of each patient 

seen would be more accurate, we do not 

believe that there is any method of 

making this determination for every 

patient without placing an undue 

burden on the provider. We continue to 

believe that limited broadband 

availability in the eligible hospital’s or 

CAH’s immediate practice area, coupled 

with the low threshold of this measure, 

adequately serves as an acceptable 

proxy for determining areas where 

online access can present a challenge for 

patients. Therefore, after consideration 

of the public comments received, we are 

finalizing the broadband exclusion as 

proposed. 

Comment: Some commenters 

suggested that the required element of 

‘‘Problem list maintained by the 

hospital on the patient’’ should be made 

consistent with the required element in 

the objective of the same name and 

changed to ‘‘Problem list.’’ Other 

commenters asked for clarification of 

‘‘Relevant past diagnoses known by the 

hospital’’ and how this element differs 

from ‘‘Problem list.’’ 

Response: We agree that this language 

should be made standard. By ‘‘Relevant 

past diagnoses known by the hospital’’ 

we mean to indicate historical entries in 

the patient’s problem list. Therefore, we 

are eliminating the ‘‘Relevant past 

diagnoses’’ element and modifying the 

problem list element to ‘‘Current and 

past problem list’’ in the list of required 

elements below. 

Comment: Some commenters 

suggested that displaying all historical 

medications for each patient under the 

required element of ‘‘Medication list 

maintained by the hospital on the 

patient (both current admission and 

historical)’’ would be too burdensome 

for hospitals. These commenters 

suggested amending the required 

element to only the active medication 

list maintained by CEHRT. They also 

expressed confusion over the use of the 

term ‘‘current admission’’ since the 

information for this measure would be 

posted after the patient’s discharge. 

Response: We believe that just as 

providing a historical problem list for 

the patient can be useful, so too can 

providing a historical list of all 

medications. To clarify the intention of 

this objective, we are modifying the 

language in the list of required elements 

below to read ‘‘Active medication list 

and medication history. Current 

admission referred to the admission and 

subsequent discharge that places the 

patient in the denominator for this 

measure. 

Comment: Some commenters 

suggested that ‘‘Laboratory test results 

(available at discharge)’’ could result in 

a large number of test results that could 

be confusing to patients. They suggested 

limiting this required element to a 

subset of lab results of a particular type 

or lab results from the last 24 hours of 

admission. 

Response: We believe that a list of all 

laboratory test results can be beneficial 

to longitudinal care, therefore, we 

decline to modify this required element 

either by type of lab result or by any 

time period beyond those lab test results 

available at discharge. 

Comment: Some commenters 

suggested that the required element of 

‘‘Care transition summary and plan for 

next provider of care (for transitions 

other than home)’’ should be made 

consistent with the required element in 

the objective of the same name and 

changed to ‘‘Care plan field, including 

goals and instructions.’’ Some 

commenters also suggested that care 

transition plans are more appropriate for 

providers than patients. 

Response: By ‘‘care transition 

summary and plan for next provider of 

care’’ we mean for eligible hospitals and 

CAHs to include both the care plan 

field(s), including goals and 

instructions, and a copy of the summary 

of care document that hospitals must 

generate and provide for the core 

objective of ‘‘The eligible hospital or 

CAH that transitions their patient to 

another setting of care or provider of 

care or refers their patient to another 

provider of care should provide 

summary care record for each transition 

of care or referral.’’ While we believe 

that the summary of care documents are 

best exchanged directly with the 

provider to whom the hospital is 

transitioning care or referring the 

patient, we also believe that providing 

an electronic copy with discharge 

information will ensure that the 

provider can easily access the 

information after the transition of 

referral. We have modified the language 

in the list of required elements below to 

reflect this. 

After consideration of the public 

comments received, we are finalizing 

the first meaningful use measure for 

eligible hospitals and CAHs at 

§ 495.6(l)(8)(ii)(A) as proposed. We are 

modifying the second meaningful use 

measure for eligible hospitals and CAHs 

to be ‘‘More than 5 percent of all 

patients (or their authorized 

representatives) who are discharged 

from the inpatient or emergency 

department (POS 21 or 23) of an eligible 

hospital or CAH view, download or 

transmit to a third party their 

information during the EHR reporting 

period’’ at § 495.6(l)(8)(ii)(B), and the 

exclusion for eligible hospitals and 

CAHs at § 495.6(l)(8)(iii) as ‘‘Any 

eligible hospital or CAH that is located 

in a county that does not have 50 

percent or more of its housing units 

with 3Mbps broadband availability 

according to the latest information 

available from the FCC on the first day 

of the EHR reporting period is excluded 

from the second measure.’’ 

We further specify that in order to 

meet this objective and measure, an 

mstockstill on DSK4VPTVN1PROD with RULES2

54040 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

eligible hospital or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(e)(1). 

To calculate the percentage of the first 

measure for providing patients timely 

access to discharge information, CMS 

and ONC have worked together to 

define the following for this objective: 

• Denominator: Number of unique 

patients discharged from an eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period. 

• Numerator: The number of patients 

in the denominator whose information 

is available online within 36 hours of 

discharge. 

• Threshold: The resulting percentage 

must be more than 50 percent in order 

for an eligible hospital or CAH to meet 

this measure. 

To calculate the percentage of the 

second measure for reporting on the 

number of unique patients discharged 

from an eligible hospital’s or CAH’s 

inpatient or emergency department 

(POS 21 or 23) during the EHR reporting 

period (or their authorized 

representatives) who view, download or 

transmit health information, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of unique 

patients discharged from an eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period. 

• Numerator: The number of unique 

patients (or their authorized 

representatives) in the denominator who 

have viewed online, downloaded, or 

transmitted to a third party the 

discharge information provided by the 

eligible hospital or CAH. 

• Threshold: The resulting percentage 

must be more than 5 percent in order for 

an eligible hospital or CAH to meet this 

measure. 

• Exclusion: Any eligible hospital or 

CAH will be excluded from the second 

measure if it is located in a county that 

does not have 50 percent or more of its 

housing units with 3Mbps broadband 

availability according to the latest 

information available from the FCC on 

the first day of the EHR reporting 

period. 

The following information must be 

available to satisfy the objective and 

measure: 

• Patient name. 

• Admit and discharge date and 

location. 

• Reason for hospitalization. 

• Care team including the attending 

of record as well as other providers of 

care. 

• Procedures performed during 

admission. 

• Current and past problem list. 

• Current medication list and 

medication history. 

• Current medication allergy list and 

medication allergy history. 

• Vital signs at discharge. 

• Laboratory test results (available at 

time of discharge). 

• Summary of care record for 

transitions of care or referrals to another 

provider. 

• Care plan field(s), including goals 

and instructions. 

• Discharge instructions for patient. 

• Demographics maintained by 

hospital (sex, race, ethnicity, date of 

birth, preferred language). 

• Smoking status. 

As noted in the proposed rule, this is 

not intended to limit the information 

made available by the hospital. A 

hospital can make available additional 

information and still align with the 

objective. Please note that while some of 

the information made available through 

this measure is similar to the 

information made available in the 

summary of care document that must be 

provided following transitions of care or 

referrals, the list of information above is 

specific to the view online, download, 

and transmit objective. Patients and 

providers have different information 

needs and contexts, so CMS has 

established separate required fields for 

each of these objectives. 

Proposed Eligible Hospital/CAH 

Objective: Record whether a patient 65 

years old or older has an advance 

directive. 

In our proposed rule, we noted that 

the HIT Policy Committee 

recommended making this a core 

objective and also requiring eligible 

hospitals and CAHs to either store an 

electronic copy of the advance directive 

in the CEHRT or link to an electronic 

copy of the advance directive. However, 

we proposed to maintain this objective 

as part of the menu set for Stage 2, and 

we did not propose the requirement of 

an electronic copy or link to the 

advance directive. As we stated in our 

Stage 1 final rule (75 FR 44345), we 

have continuing concerns that there are 

potential conflicts between storing 

advance directives and existing state 

laws. Also, we believe that because of 

state law restrictions, an advance 

directive stored in an EHR may not be 

actionable. Finally, we believe that 

eligible hospitals and CAHs may have 

other methods of satisfying the intent of 

this objective at this time, although we 

recognize that these workflows may 

change as EHR technology develops and 

becomes more widely adopted. 

Therefore, we did not propose to adopt 

the HIT Policy Committee’s 

recommendations for this objective. 

The HIT Policy Committee has also 

recommended the inclusion of this 

objective for EPs in Stage 2. In our Stage 

1 final rule (75 FR 44345), we indicated 

our belief that many EPs will not record 

this information under current 

standards of practice and will only 

require information about a patient’s 

advance directive in rare circumstances. 

We continue to believe this is the case 

and that creating a list of specialties or 

types of EPs that will be excluded from 

the objective will be too cumbersome 

and still might not be comprehensive. 

Therefore, we did not propose the 

recording of the existence of advance 

directives as an objective for EPs in 

Stage 2. However, we solicited public 

comment on this decision and 

encouraged commenters to address 

specific concerns regarding scope of 

practice and ease of compliance for EPs. 

And we note that nothing in this rule 

compels the use of advance directives. 

Comment: While some commenters 

supported the HIT Policy Committee’s 

recommendations, many recommended 

that we keep this measure as part of the 

menu set. We received several 

comments about a link or copy of the 

advance directives, and these 

commenters generally supported our 

proposal of not including this as part of 

the objective. 

Response: While we appreciate the 

commenters support and the HITPC’s 

reiteration of their recommendation, 

neither the HITPC nor other 

commenters provided new information 

that would address our concerns 

regarding conflicting state laws. 

Comment: While most commenters 

agreed that this objective should not be 

extended to EPs at this time, a select few 

suggested adding it as part of the menu 

set. 

Response: We are not extending this 

objective to EPs. Our belief that many 

EPs would not record this information 

under current standards of practice was 

supported by commenters. Also, we 

continue to believe that creating a list of 

specialties or types of EPs that would be 

excluded from the objective would be 

too cumbersome and would not be 

comprehensive. 

After consideration of public 

comments, we are finalizing this 

objective for eligible hospitals and 

CAHs at § 495.6(m)(1)(i) as proposed. 

Proposed Eligible Hospital/CAH 

Measure: More than 50 percent of all 

unique patients 65 years old or older 

admitted to the eligible hospital’s or 

CAH’s inpatient department (POS 21) 

during the EHR reporting period have 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54041 

an indication of an advance directive 

status recorded as structured data. 

In the proposed rule, we explained 

that the calculation of the denominator 

for the measure of this objective is 

limited to unique patients age 65 or 

older who are admitted to an eligible 

hospital’s or CAH’s inpatient 

department (POS 21). Patients admitted 

to an emergency department (POS 23) 

should not be included in the 

calculation. As we discussed in our 

Stage 1 final rule (75 FR 44345), we 

believe that this information is a level 

of detail that is not practical to collect 

on every patient admitted to the eligible 

hospital’s or CAH’s emergency 

department, and therefore, have limited 

this measure only to the inpatient 

department of the hospital. 

Comment: A commenter indicated 

that nearly 70 percent of hospitals could 

meet this measure in Fall 2011. 

Response: Data collected from Stage 1 

attestations shows that less than 15 

percent of hospitals deferred this 

measure. 

After consideration of public 

comments, we are finalizing this 

measure for eligible hospitals and CAHs 

at § 495.6(m)(1)(ii) as proposed. We are 

maintaining the exclusion for any 

eligible hospital or CAH that admits no 

patients age 65 years old or older during 

the EHR reporting period. 

We further specify that in order to 

meet this objective and measure, an EP 

must use the capabilities and standards 

of CEHRT at 45 CFR 170.314(a)(17). 

• Denominator: Number of unique 

patients age 65 or older admitted to an 

eligible hospital’s or CAH’s inpatient 

department (POS 21) during the EHR 

reporting period. 

• Numerator: The number of patients 

in the denominator who have an 

indication of an advance directive status 

entered using structured data. 

• Threshold: The resulting percentage 

must be more than 50 percent in order 

for an eligible hospital or CAH to meet 

this measure. 

• Exclusion: Any eligible hospital or 

CAH that admits no patients age 65 

years old or older during the EHR 

reporting period. 

(f) HIT Policy Committee Recommended 

Objectives Discussed in the Proposed 

Rule Without Proposed Regulation Text 

We did not propose these objectives 

for Stage 2 as explained at each 

objective, but we solicited comments on 

whether these objectives should be 

incorporated into Stage 2. 

Hospital Objective: Provide structured 

electronic lab results to eligible 

professionals. 

Although the HITPC recommended 

this as a core objective for Stage 2 for 

hospitals, we did not propose this 

objective for the following reasons as 

explained in the proposed rule. 

Although hospital labs supply nearly 

half of all lab results, they are not the 

predominant vendors for providers who 

do not share or cannot access their 

technology. Independent and office 

laboratories provide over half of the labs 

in this market. We stated that we were 

concerned that imposing this 

requirement on hospital labs would 

unfairly disadvantage them in this 

market. Furthermore, not all hospitals 

offer these services so it would create a 

natural disparity in meaningful use 

between those hospitals offering these 

services and those that do not. Finally, 

all other aspects of meaningful use in 

Stage 1 and Stage 2 focus on the 

inpatient and emergency departments of 

a hospital. This objective is not related 

to these departments, and in fact 

excludes services provided in these 

departments. We asked for comments on 

both the pros and cons of this objective 

and whether it should be considered for 

this final rule as recommended by the 

HITPC. 

Comment: Nearly all of the 

commenters that supported the 

inclusion of this objective based their 

support wholly or in part on the concept 

that the benefits of hospitals providing 

structured electronic lab results 

outweigh the costs of doing so. They 

point to specific benefits, such as 

making it more likely that EPs will be 

able to meet the meaningful use 

measure of incorporating clinical labtest results into CEHRT as structured 

data, as well as more general benefits of 

structured electronic results. 

Response: The large number of 

commenters in support of this objective 

and the associated benefits they 

identified make a compelling case for 

inclusion. In particular, inclusion of this 

objective will enable EPs to incorporate 

laboratory test results into the CEHRT as 

structured data, which in turn adds to 

the ability of CEHRT to provide CDS 

and to calculate clinical quality 

measures. In addition, this objective 

will improve consistency in the market 

by incentivizing the use of the uniform 

standard for laboratory exchange 

transactions included in CEHRT as 

established in ONC’s certification 

criteria at (ONC reference once 

available). However, the benefits 

identified are somewhat tempered by 

the makeup of the commenters 

supporting the inclusion of this 

objective, who are usually those who 

stand to benefit (EPs, patient advocates 

and others), whereas those who did not 

support inclusion are usually those who 

would bear the burden (hospitals and 

vendors). We summarize and respond to 

the comments in opposition later. 

However, due to the strong 

disagreements among commenters about 

the inclusion of this objective, and also 

concern for market impact discussed in 

the comments later, we will include it 

in the menu set of Stage 2 and not in 

the core set as recommended by the 

HITPC and supported by some of the 

commenters. 

Comment: Several commenters 

questioned the applicability of this 

objective to meaningful use. Most stated 

that it was not applicable for several 

reasons. First, commenters asserted it is 

beyond the statutory authority of the 

Medicare EHR Incentive Program, 

which is established in sections of the 

statute that govern payment for hospital 

inpatient services, whereas laboratory 

services are paid under a different 

payment system. Second, as meaningful 

use is currently constrained to the 

inpatient and emergency departments, it 

would be inconsistent to expand it to 

include lab results for patients that are 

not admitted to either the inpatient or 

emergency department of the hospital. 

Third, systems used by hospitals to 

process and send laboratory results are 

not traditionally considered part of 

CEHRT, and including those systems in 

CEHRT could have many unintended 

consequences and costs. 

Response: We believe the statute 

supports a definition of meaningful use 

that is not limited to actions taken 

within the inpatient department of a 

hospital. The meaningful use incentive 

payments and payment adjustments for 

Medicare eligible hospitals are 

established in sections of the Act that 

are under the hospital inpatient 

prospective payment system (IPPS) 

(sections 1886(n) and 1886(b)(3)(B)(ix) 

of the Act, respectively). However, the 

statutory definition of a ‘‘meaningful 

EHR user’’ under section 1886(n)(3) of 

the Act does not constrain the use of 

CEHRT to the inpatient department of 

the hospital. The definition requires in 

part that an eligible hospital must use 

CEHRT ‘‘for the electronic exchange of 

health information to improve the 

quality of health care, such as 

promoting care coordination’’ (section 

1886(n)(3)(A)(ii)), which the objective of 

providing structured electronic lab 

results to ambulatory providers would 

support. Moreover, the majority of 

hospital objectives for Stages 1 and 2 of 

meaningful use take into account 

actions performed in the emergency 

department as well as the inpatient 

department. In the Stage 1 final rule, we 

indicated that we may consider 

mstockstill on DSK4VPTVN1PROD with RULES2

54042 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

applying the Stage 2 criteria more 

broadly to all hospital outpatient 

settings beyond the emergency 

department (75 FR 44322). One of the 

primary reasons not to include 

outpatient settings in meaningful use for 

hospitals is the potential for overlap 

with settings where EPs typically would 

use CEHRT. We believe there is minimal 

risk of such overlap with this objective, 

as it involves a function that is 

controlled by the hospital, and for 

which EPs are a recipient and not a 

provider of information. In regards to 

the third reason identified by 

commenters, CEHRT and meaningful 

use already include the ability to report 

electronic lab results to public health 

agencies, so consequences and costs of 

such inclusion should have already 

occurred. The impact of including these 

systems in certification is addressed in 

the ONC regulation published elsewhere 

in this issue of the Federal Register. 

Comment: A few commenters 

supported this objective because they 

believe that hospital labs have lagged 

behind independent labs in providing 

electronic results. 

Response: We agree that hospital lab 

reporting should be included as a menu 

set objective, but without actual data 

demonstrating lags by hospitals in 

laboratory exchange with ambulatory 

providers, we do not find this to be a 

compelling reason to include the 

objective as part of the core set. 

Comment: Commenters believed this 

objective is inappropriate because the 

meaningful use regulations do not apply 

to commercial clinical laboratories, 

leading to an adverse market impact for 

hospitals in competition with others 

that process laboratory results for 

physician offices. The operational 

impacts of this objective are significant. 

In the absence of functional health 

information exchanges, hospitals would 

need to create and maintain separate, 

system-to-system interfaces with each 

physician office that receives laboratory 

results electronically, at considerable 

cost and effort. The transition to using 

standardized code sets in laboratories 

that must continue to function is 

challenging and burdensome, 

particularly for small hospitals. 

Response: For these reasons, we 

include this objective and measure in 

the menu set. Those hospitals that see 

competitive benefits in providing 

electronic lab results to ambulatory 

providers may wish to select this as a 

menu set objective. Those who believe 

that building out the capability to 

provide electronic lab results is not 

beneficial in their competitive market 

environments can defer the objective. 

Similarly, those hospitals that consider 

the burden too high can defer this 

objective. 

After consideration of public 

comments, we are including this 

objective in the menu set for eligible 

hospitals and CAHs at § 495.6(m)(6)(i) 

as ‘‘Provide structured electronic lab 

results to ambulatory providers.’’ 

For each objective, we outline the 

benefits expected from that objective. 

We did not include these benefits in our 

proposed rule and we are adding them 

to this final rule. Hospitals sending 

structured lab results electronically to 

EPs using CEHRT and in accordance 

with designated standards will directly 

enhance the ability of EPs to meet 

meaningful use objectives, including 

incorporating laboratory test results into 

the EHR as structured data, generating 

lists of patients with particular 

conditions, utilizing clinical decision 

support, and enhancing the ability to 

calculate clinical quality measures. The 

addition of this objective will help 

improve consistency in the market, in 

contrast to today’s environment in 

which inconsistencies in interface 

requirements are hindering the delivery 

of structured hospital lab results to 

ambulatory EHRs. This objective will 

also benefit hospitals by creating a 

uniform standard for laboratory 

exchange transactions, which will 

eliminate variation, reducing interface 

costs and time to deploy. 

Hospital Measure: Hospital labs send 

(directly or indirectly) structured 

electronic clinical lab results to the 

ordering provider for more than 40 

percent of electronic lab orders 

received. 

The measure for this objective 

recommended by the HIT Policy 

Committee is that 40 percent of clinical 

lab test results electronically sent by an 

eligible hospital or CAH will need to be 

done so using the capabilities CEHRT. 

This measure requires that in situations 

where the electronic connectivity 

between an eligible hospital or CAH and 

an EP is established, the results 

electronically exchanged are done so 

using CEHRT. To facilitate the ease with 

which this electronic exchange may take 

place, ONC proposed that for 

certification, ambulatory EHR 

technology will need to be able to 

incorporate lab test results formatted in 

the same standard and implementation 

specifications to which inpatient EHR 

technology will need to be certified as 

being able to create. 

Comment: Some commenters who 

support this objective raised concerns 

that small hospitals might not be able to 

comply due to the burden involved and 

suggest an unspecified exclusion for 

them. 

Response: By including this objective 

as a menu set item, those hospitals that 

view lab reporting to ambulatory 

practices as too burdensome can defer 

this measure. 

Comment: Some commenters 

supporting the measure indicated that 

they would like to see hospital reference 

labs that are already providing 

electronic lab results to ordering 

providers ‘‘grandfathered’’ into the 

measure. 

Response: There are two reasons that 

a hospital providing electronic lab 

results already would need special 

consideration. First, they are not using 

the standards of CEHRT where 

available. Second, they may not have 

gotten the system they use certified. As 

it is meaningful use of CEHRT we do 

not believe that we should include 

exceptions to the use of CEHRT in 

meaningful use. We do not believe that 

providers must ‘‘rip and replace’’ 

existing systems. Existing systems that 

support the standards of CEHRT can be 

certified for inclusion and those that do 

not support the standards can defer the 

objective until they upgrade to the 

standards of CEHRT. 

Comment: Commenters expressed 

concern that if the objective is included 

in meaningful use that the threshold is 

unattainable. They noted that for a 

hospital to send electronic lab results 

the EP must be able to receive electronic 

results and that current adoption rates 

do not indicate that 40 percent of EPs 

will be able to receive electronic lab 

results. 

Response: The measure uses a 

denominator of electronic lab orders 

received so this consideration is already 

built into the measure. However, we do 

agree with commenters that 40 percent 

is a high threshold for this completely 

new measure as it is dependent on 

electronic health exchange. For the final 

measure we reduce the threshold to 20 

percent. While we considered lowering 

the threshold to 10 percent, the 

denominator limitation that the lab 

order must be received electronically 

already limits the measure to those 

ordering providers capable of 

submitting electronic orders and implies 

at least some electronic health 

information exchange has been 

established between the hospital and 

the ordering provider. 

After considering the comments, we 

are finalizing this measure for eligible 

hospitals and CAHs at § 495.6(m)(6)(ii) 

as ‘‘Hospital labs send structured 

electronic clinical lab results to the 

ordering provider for more than 20 

percent of electronic lab orders 

received.’’ 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54043 

In order to be counted in the 

numerator, the hospital would need to 

use CEHRT to send laboratory results to 

the ambulatory provider in a way that 

has the potential for electronic 

incorporation of those results as 

structure data. Methods that have no 

potential for automatic incorporation 

such as ‘‘portal view’’ do not count in 

the numerator. We further specify that 

in order to meet this objective and 

measure, an EP, eligible hospital, or 

CAH must use the capabilities and 

standards of CEHRT at 45 CFR 

170.314(b)(6). 

• Denominator: The number of 

electronic lab orders received. 

• Numerator: The number of 

structured clinical lab results sent to the 

ordering provider. 

• Threshold: The resulting percentage 

must be greater than 20 percent. 

EP Objective/Measure: Record patient 

preferences for communication medium 

for more than 20 percent of all unique 

patients seen during the EHR reporting 

period. 

We proposed that this requirement is 

better incorporated with other objectives 

that require patient communication and 

is not necessary as a standalone 

objective. 

Commenters were supportive of the 

incorporation of this objective and we 

continue to believe that it is better 

incorporated; therefore, we are 

finalizing this provision as proposed. 

Objective/Measure: Record care plan 

goals and patient instructions in the 

care plan for more than 10 percent of 

patients seen during the reporting 

period. 

We proposed that this requirement is 

better incorporated with other objectives 

that require summary of care documents 

and is not necessary as a standalone 

objective. 

Commenters were supportive of the 

incorporation of this objective as 

proposed and we continue to believe 

that it is better incorporated; therefore, 

we are finalizing this provision as 

proposed. 

Objective/Measure: Record health care 

team members (including at a minimum 

PCP, if available) for more than 10 

percent of all patients seen during the 

reporting period; this information can 

be unstructured. 

We proposed that this requirement is 

better incorporated with other objectives 

that require summary of care documents 

and is not necessary as a standalone 

objective. 

Commenters were supportive of the 

incorporation of this objective as 

proposed and we continue to believe 

that it is better incorporated; therefore, 

we are finalizing as proposed. 

Objective/Measure: Record electronic 

notes in patient records for more than 

30 percent of office visits. 

In the proposed rule, we encouraged 

public comment regarding the inclusion 

of this objective/measure. We noted that 

narrative entries are considered an 

important component of patient records 

and complement the structured data 

captured in CEHRT. We also noted our 

understanding that electronic notes are 

already widely used by providers and 

therefore may not need to include this 

as a meaningful use objective. 

Comment: Commenters agreed that 

existing technology has the capability to 

capture notes in an electronic form for 

inclusion in the patient record. Other 

commenters mentioned that not all 

CEHRT in use currently include the 

capability to incorporate narrative 

clinical documentation. 

Response: We reiterate the statement 

in the proposed rule regarding the 

important contribution of narrative 

clinical documentation in the patient 

record. In light of the comments that not 

all CEHRT currently has the capability 

to incorporate this clinical 

documentation, we agree to incorporate 

this functionality to record electronic 

notes as an additional menu objective 

for Stage 2 of meaningful use. The ONC 

standards and certification criteria final 

rule associated with this objective/ 

measure is published elsewhere in this 

issue of the Federal Register. We 

believe that inclusion of electronic 

patient notes to the meaningful use 

menu objectives is another incremental 

step towards maximizing the potential 

of EHR technology. 

Comment: The HIT Policy Committee 

commented that this objective/measure 

should apply to both EPs, eligible 

hospitals and CAHs because some 

certified EHRs do not have clinical 

documentation and because they believe 

that a complete record (including 

progress notes) is required to deliver 

high quality, efficient care. 

Response: We agree and are adopting 

this objective in the menu set for Stage 

2 for EPs, eligible hospitals and CAHs 

in order to allow providers access to the 

most accurate and complete patient 

information available electronically to 

support quality of care efforts across 

patient care settings. 

Comment: A commenter suggested 

that if this objective/measure becomes 

part of the final rule it will require a 

clear definition of how notes are defined 

and who may create, edit and sign them 

in order to be included in the measure 

numerator. Other commenters requested 

clarification of the term electronic note 

and whether it would include nursing 

notes, flow sheets, operative reports, 

discharge summaries, consults, etc. in 

addition to basic progress notes. 

Response: For this objective, we have 

determined that any EP as defined for 

the Medicare or Medicaid EHR 

Incentive Programs, or an authorized 

provider of the eligible hospital’s or 

CAH’s inpatient or emergency 

departments (POS 21 or 23) may author, 

edit, and provide an electronic signature 

for the electronic notes in order for them 

to be considered for this measure. We 

further define electronic notes as 

electronic progress notes for the purpose 

of this measure. We will rely on 

providers own determinations and 

guidelines defining when progress notes 

are necessary to communicate 

individual patient circumstances and 

for coordination with previous 

documentation of patient observations, 

treatments and/or results in the 

electronic health record. 

Comment: Many commenters agreed 

with the inclusion of the text searchable 

certification requirement and agreed 

that portions of clinical notes are 

already being collected electronically. 

The HIT Policy Committee 

recommended inclusion of this measure 

because some certified EHRs do not 

have clinical documentation, and 

believe that the benefit of a complete 

patient record, including progress notes, 

is required to deliver high quality, 

efficient care. Several commenters were 

opposed to the inclusion of this 

additional measure in order to limit the 

number of reporting objectives. 

Response: Based on the multiple 

reasons stated in this preamble we agree 

with the benefits of including the 

electronic progress notes measure in the 

menu set for the Stage 2 meaningful use 

objectives. We envision continued 

technological advances in the capture 

and processing of text and diagrammatic 

data such as research of natural 

language processing. We also believe 

there is added value in collecting both 

narrative data and structured data in the 

EHR and using that information to track 

key clinical conditions and 

communicating that information for care 

coordination purposes. Therefore, we 

are including this objective/measure to 

record electronic notes in the patient 

records for more than 30 percent of 

office visits or unique patients admitted 

to an eligible hospital’s or CAH’s 

inpatient or emergency department 

(POS 21 or 23) as was originally 

recommended by the HITPC. 

After consideration of public 

comments, we are finalizing this 

objective for EPs at § 495.6 (k)(6)(i) and 

for eligible hospitals and CAHs at 

§ 495.6(m)(5)(i) as ‘‘Record electronic 

notes in patient records.’’ 

mstockstill on DSK4VPTVN1PROD with RULES2

54044 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

We are adding the measure for EPs at 

§ 495.6(k)(6)(ii) and for eligible hospitals 

and CAHs at § 495.6(m)(5)(ii) of our 

regulations to include this new measure: 

EP Menu Measure: Enter at least one 

electronic progress note created, edited 

and signed by an EP for more than 30 

percent of unique patients with at least 

one office visit during the EHR reporting 

period. Electronic progress notes must 

be text-searchable. Non-searchable notes 

do not qualify, but this does not mean 

that all of the content has to be character 

text. Drawings and other content can be 

included with searchable text notes 

under this measure. 

Eligible Hospital/CAH Menu Measure: 

Enter at least one electronic progress 

note created, edited and signed by an 

authorized provider of the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

for more than 30 percent of unique 

patients admitted to the eligible hospital 

or CAH’s inpatient or emergency 

department during the EHR reporting 

period. Electronic progress notes must 

be text-searchable. Non-searchable notes 

do not qualify, but this does not mean 

that all of the content has to be character 

text. Drawings and other content can be 

included with searchable text notes 

under this measure. 

We further specify that in order to 

meet this objective and measure, an EP, 

eligible hospital, or CAH must use the 

capabilities and standards of CEHRT at 

45 CFR 170.314(a)(9). 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for these measures: 

• Denominator: Number of unique 

patients with at least one office visit 

during the EHR reporting period for EPs 

or admitted to an eligible hospital or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period. 

• Numerator: The number of unique 

patients in the denominator who have at 

least one electronic progress note from 

an eligible professional or authorized 

provider of the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) recorded as 

text-searchable data. 

• Threshold: The resulting percentage 

must be more than 30 percent in order 

for an EP, eligible hospital or CAH to 

meet this measure. 

TABLE B5—STAGE 2 OBJECTIVES AND MEASURES

Health outcomes policy priority 

Stage 2 objectives 

Stage 2 measures 

Eligible professionals Eligible hospitals and CAHs 

CORE SET 

Improving quality, safety, efficiency, and reducing health disparities.Use computerized provider order 

entry (CPOE) for medication, 

laboratory and radiology orders 

directly entered by any licensed 

healthcare professional who 

can enter orders into the medical record per state, local and 

professional guidelines.

Use computerized provider order 

entry (CPOE) for medication, 

laboratory and radiology orders 

directly entered by any licensed 

healthcare professional who 

can enter orders into the medical record per state, local and 

professional guidelines.

More than 60 percent of medication, 30 percent of laboratory, 

and 30 percent of radiology orders created by the EP or authorized providers of the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 

21 or 23) during the EHR reporting period are recorded 

using CPOE. 

Generate and transmit permissible prescriptions electronically 

(eRx).

....................................................... More than 50 percent of all permissible prescriptions, or all 

prescriptions written by the EP 

and queried for a drug formulary and transmitted electronically using CEHRT. 

Record the following demographics: 

• Preferred language 

• Sex 

• Race 

• Ethnicity 

• Date of birth 

Record the following demographics: 

• Preferred language 

• Sex 

• Race 

• Ethnicity 

• Date of birth 

• Date and preliminary cause 

of death in the event of 

mortality in the eligible hospital or CAH. 

More than 80 percent of all 

unique patients seen by the EP 

or admitted to the eligible hospital’s or CAH’s inpatient or 

emergency department (POS 

21 or 23) during the EHR reporting period have demographics recorded as structured 

data. 

Record and chart changes in vital 

signs: 

• Height/length 

• Weight 

• Blood pressure (age 3 and 

over) 

• Calculate and display BMI 

• Plot and display growth 

charts for patients 0–20 

years, including BMI 

Record and chart changes in vital 

signs: 

• Height/length 

• Weight 

• Blood pressure (age 3 and 

over) 

• Calculate and display BMI 

• Plot and display growth 

charts for patients 0–20 

years, including BMI 

More than 80 percent of all 

unique patients seen by the EP 

or admitted to the eligible hospital’s or CAH’s inpatient or 

emergency department (POS 

21 or 23) during the EHR reporting period have blood pressure (for patients age 3 and 

over only) and height/length 

and weight (for all ages) recorded as structured data. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54045 

TABLE B5—STAGE 2 OBJECTIVES AND MEASURES—Continued 

Health outcomes policy priority 

Stage 2 objectives 

Stage 2 measures 

Eligible professionals Eligible hospitals and CAHs 

Record smoking status for patients 13 years old or older.Record smoking status for patients 13 years old or older.More than 80 percent of all 

unique patients 13 years old or 

older seen by the EP or admitted to the eligible hospital’s or 

CAH’s inpatient or emergency 

departments (POS 21 or 23) 

during the EHR reporting period 

have smoking status recorded 

as structured data. 

Use clinical decision support to 

improve performance on highpriority health conditions.

Use clinical decision support to 

improve performance on highpriority health conditions.

1. Implement five clinical decision 

support interventions related to 

four or more clinical quality 

measures at a relevant point in 

patient care for the entire EHR 

reporting period. Absent four 

clinical quality measures related 

to an EP, eligible hospital or 

CAH’s scope of practice or patient population, the clinical decision support interventions 

must be related to high-priority 

health conditions. It is suggested that one of the five clinical decision support interventions be related to improving 

healthcare efficiency. 

2. The EP, eligible hospital, or 

CAH has enabled and implemented the functionality for 

drug and drug allergy interaction checks for the entire 

EHR reporting period. 

Incorporate clinical lab-test results 

into Certified EHR Technology 

as structured data. 

Incorporate clinical lab-test results 

into Certified EHR Technology 

as structured data.

More than 55 percent of all clinical lab tests results ordered by 

the EP or by authorized providers of the eligible hospital or 

CAH for patients admitted to its 

inpatient or emergency department (POS 21 or 23) during the 

EHR reporting period whose results are either in a positive/ 

negative affirmation or numerical format are incorporated in 

Certified EHR Technology as 

structured data. 

Generate lists of patients by specific conditions to use for quality 

improvement, reduction of disparities, research, or outreach 

Generate lists of patients by specific conditions to use for quality 

improvement, reduction of disparities, research, or outreach. 

Generate at least one report listing patients of the EP, eligible 

hospital or CAH with a specific 

condition. 

Use clinically relevant information 

to identify patients who should 

receive reminders for preventive/follow-up care and send 

these patients the reminder, per 

patient preference.

....................................................... More than 10 percent of all 

unique patients who have had 

two or more office visits with 

the EP within the 24 months 

before the beginning of the 

EHR reporting period were sent 

a reminder, per patient preference when available. 

Automatically track medications 

from order to administration 

using assistive technologies in 

conjunction with an electronic 

medication administration 

record (eMAR). 

More than 10 percent of medication orders created by authorized providers of the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 

21 or 23) during the EHR reporting period for which all 

doses are tracked using eMAR. 

mstockstill on DSK4VPTVN1PROD with RULES2

54046 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE B5—STAGE 2 OBJECTIVES AND MEASURES—Continued 

Health outcomes policy priority 

Stage 2 objectives 

Stage 2 measures 

Eligible professionals Eligible hospitals and CAHs 

Engage patients and families in 

their health care.

Provide patients the ability to view 

online, download, and transmit 

their health information within 4 

business days of the information being available to the EP. 

....................................................... 1. More than 50 percent of all 

unique patients seen by the EP 

during the EHR reporting period 

are provided timely (within 4 

business days after the information is available to the EP) 

online access to their health information subject to the EP’s 

discretion to withhold certain information. 

2. More than 5 percent of all 

unique patients seen by the EP 

during the EHR reporting period 

(or their authorized representatives) view, download, or transmit to a third party their health 

information. 

Provide patients the ability to view 

online, download, and transmit 

information about a hospital admission. 

1. More than 50 percent of all patients who are discharged from 

the inpatient or emergency department (POS 21 or 23) of an 

eligible hospital or CAH have 

their information available online within 36 hours of discharge. 

2. More than 5 percent of all patients (or their authorized representatives) who are discharged from the inpatient or 

emergency department (POS 

21 or 23) of an eligible hospital 

or CAH view, download or 

transmit to a third party their information during the reporting 

period. 

Provide clinical summaries for patients for each office visit........................................................ Clinical summaries provided to 

patients or patient-authorized 

representatives within 1 business day for more than 50 percent of office visits. 

Use Certified EHR Technology to 

identify patient-specific education resources and provide 

those resources to the patient.

Use Certified EHR Technology to 

identify patient-specific education resources and provide 

those resources to the patient.

Patient-specific education resources identified by CEHRT 

are provided to patients for 

more than 10 percent of all 

unique patients with office visits 

seen by the EP during the EHR 

reporting period. 

More than 10 percent of all 

unique patients admitted to the 

eligible hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) are provided patient-specific education 

resources identified by Certified 

EHR Technology. 

Use secure electronic messaging 

to communicate with patients 

on relevant health information.

....................................................... A secure message was sent 

using the electronic messaging 

function of Certified EHR Technology by more than 5 percent 

of unique patients (or their authorized representatives) seen 

by the EP during the EHR reporting period. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54047 

TABLE B5—STAGE 2 OBJECTIVES AND MEASURES—Continued 

Health outcomes policy priority 

Stage 2 objectives 

Stage 2 measures 

Eligible professionals Eligible hospitals and CAHs 

Improve care coordination ............. The EP who receives a patient 

from another setting of care or 

provider of care or believes an 

encounter is relevant should 

perform medication reconciliation. 

The eligible hospital or CAH who 

receives a patient from another 

setting of care or provider of 

care or believes an encounter is 

relevant should perform medication reconciliation.

The EP, eligible hospital or CAH 

performs medication reconciliation for more than 50 percent 

of transitions of care in which 

the patient is transitioned into 

the care of the EP or admitted 

to the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23). 

The EP who transitions their patient to another setting of care 

or provider of care or refers 

their patient to another provider 

of care provides a summary 

care record for each transition 

of care or referral.

The eligible hospital or CAH who 

transitions their patient to another setting of care or provider 

of care or refers their patient to 

another provider of care provides a summary care record 

for each transition of care or referral.

1. The EP, eligible hospital, or 

CAH that transitions or refers 

their patient to another setting 

of care or provider of care provides a summary of care record 

for more than 50 percent of 

transitions of care and referrals. 

2. The EP, eligible hospital or 

CAH that transitions or refers 

their patient to another setting 

of care or provider of care provides a summary of care record 

for more than 10% of such transitions and referrals either—(a) 

electronically transmitted using 

CEHRT to a recipient or (b) 

where the recipient receives the 

summary of care record via exchange facilitated by an organization that is a NwHIN Exchange participant or in a manner that is consistent with the 

governance mechanism ONC 

establishes for the nationwide 

health information network. 

3. An EP, eligible hospital or CAH 

must satisfy one of the two following criteria: 

(A) Conducts one or more 

successful electronic exchanges of a summary of 

care document, as part of 

which is counted in ‘‘measure 2’’ (for EPs the measure at § 495.6(j)(14)(ii)(B) 

and for eligible hospitals 

and CAHs the measure at 

§ 495.6(l)(11)(ii)(B)) with a 

recipient who has EHR 

technology that was developed designed by a different EHR technology developer than the sender’s 

EHR technology certified to 

45 CFR 170.314(b)(2); or 

(B) Conducts one or more 

successful tests with the 

CMS designated test EHR 

during the EHR reporting 

period. 

Improve population and public 

health.

Capability to submit electronic 

data to immunization registries 

or immunization information 

systems except where prohibited, and in accordance with applicable law and practice.

Capability to submit electronic 

data to immunization registries 

or immunization information 

systems except where prohibited, and in accordance with applicable law and practice.

Successful ongoing submission of 

electronic immunization data 

from Certified EHR Technology 

to an immunization registry or 

immunization information system for the entire EHR reporting 

period. 

mstockstill on DSK4VPTVN1PROD with RULES2

54048 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE B5—STAGE 2 OBJECTIVES AND MEASURES—Continued 

Health outcomes policy priority 

Stage 2 objectives 

Stage 2 measures 

Eligible professionals Eligible hospitals and CAHs 

Capability to submit electronic reportable laboratory results to 

public health agencies, except 

where prohibited, and in accordance with applicable law 

and practice.

Successful ongoing submission of 

electronic reportable laboratory 

results from Certified EHR 

Technology to public health 

agencies for the entire EHR reporting period. 

Capability to submit electronic 

syndromic surveillance data to 

public health agencies, except 

where prohibited, and in accordance with applicable law 

and practice.

Successful ongoing submission of 

electronic syndromic surveillance data from Certified EHR 

Technology to a public health 

agency for the entire EHR reporting period. 

Ensure adequate privacy and security protections for personal 

health information.

Protect electronic health information created or maintained by 

the Certified EHR Technology 

through the implementation of 

appropriate technical capabilities.

Protect electronic health information created or maintained by 

the Certified EHR Technology 

through the implementation of 

appropriate technical capabilities.

Conduct or review a security risk 

analysis in accordance with the 

requirements under 45 CFR 

164.308(a)(1), including addressing the encryption/security 

of data stored in CEHRT in accordance with requirements 

under 45 CFR 164.312(a)(2)(iv) 

and 45 CFR 164.306(d)(3), and 

implement security updates as 

necessary and correct identified 

security deficiencies as part of 

the provider’s risk management 

process. 

MENU SET 

Improving quality, safety, efficiency, and reducing health disparities........................................................ Record whether a patient 65 

years old or older has an advance directive.

More than 50 percent of all 

unique patients 65 years old or 

older admitted to the eligible 

hospital’s or CAH’s inpatient 

department (POS 21) during 

the EHR reporting period have 

an indication of an advance directive status recorded as 

structured data. 

Imaging results consisting of the 

image itself and any explanation or other accompanying 

information are accessible 

through Certified EHR Technology. 

Imaging results consisting of the 

image itself and any explanation or other accompanying 

information are accessible 

through Certified EHR Technology. 

More than 10 percent of all tests 

whose result is one or more images ordered by the EP or by 

an authorized provider of the eligible hospital or CAH for patients admitted to its inpatient or 

emergency department (POS 

21 and 23) during the EHR reporting period are accessible 

through Certified EHR Technology. 

Record patient family health history as structured data.Record patient family health history as structured data.More than 20 percent of all 

unique patients seen by the EP 

or admitted to the eligible hospital or CAH’s inpatient or 

emergency department (POS 

21 or 23) during the EHR reporting period have a structured 

data entry for one or more firstdegree relatives. 

Generate and transmit permissible discharge prescriptions 

electronically (eRx).

More than 10 percent of hospital 

discharge medication orders for 

permissible prescriptions (for 

new, changed, and refilled prescriptions) are queried for a 

drug formulary and transmitted 

electronically using Certified 

EHR Technology. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54049 

TABLE B5—STAGE 2 OBJECTIVES AND MEASURES—Continued 

Health outcomes policy priority 

Stage 2 objectives 

Stage 2 measures 

Eligible professionals Eligible hospitals and CAHs 

Record electronic notes in patient 

records.

Record electronic notes in patient 

records.

Enter at least one electronic 

progress note created, edited 

and signed by an eligible professional for more than 30 percent of unique patients with at 

least one office visit during the 

EHR reporting period. 

Enter at least one electronic 

progress note created, edited 

and signed by an authorized 

provider of the eligible hospital’s or CAH’s inpatient or 

emergency department (POS 

21 or 23) for more than 30 percent of unique patients admitted 

to the eligible hospital or CAH’s 

inpatient or emergency department during the EHR reporting 

period. Electronic progress 

notes must be text-searchable. 

Non-searchable notes do not 

qualify, but this does not mean 

that all of the content has to be 

character text. Drawings and 

other content can be included 

with searchable text notes 

under this measure. 

Provide structured electronic lab 

results to ambulatory providers.

Hospital labs send structured 

electronic clinical lab results to 

the ordering provider for more 

than 20 percent of electronic 

lab orders received. 

Improve Population and Public 

Health.

Capability to submit electronic 

syndromic surveillance data to 

public health agencies, except 

where prohibited, and in accordance with applicable law 

and practice.

....................................................... Successful ongoing submission of 

electronic syndromic surveillance data from Certified EHR 

Technology to a public health 

agency for the entire EHR reporting period. 

Capability to identify and report 

cancer cases to a public health 

central cancer registry, except 

where prohibited, and in accordance with applicable law 

and practice. 

....................................................... Successful ongoing submission of 

cancer case information from 

CEHRT to a public health central cancer registry for the entire 

EHR reporting period. 

Capability to identify and report 

specific cases to a specialized 

registry (other than a cancer 

registry), except where prohibited, and in accordance with applicable law and practice. 

....................................................... Successful ongoing submission of 

specific case information from 

Certified EHR Technology to a 

specialized registry for the entire EHR reporting period. 

B. Reporting on Clinical Quality 

Measures Using Certified EHR 

Technology by Eligible Professionals, 

Eligible Hospitals, and Critical Access 

Hospitals 

The following sections address CQMs 

reporting requirements using CEHRT. 

These include: EHR technology 

certification requirements; criteria for 

CQM selection; time periods for 

reporting CQMs; issues related to 

specifications for CQMs and 

transmission formats; reporting options 

and CQMs for EPs; reporting methods 

for EPs; reporting options and CQMs for 

eligible hospitals and CAHs; and 

reporting methods for eligible hospitals 

and CAHs. 

1. Time Periods for Reporting CQMs 

This section addresses the reporting 

periods and submission periods as they 

relate to reporting CQMs only. For a 

summary of the reporting and 

submission periods proposed for CQMs, 

please refer to Table 5 in the Stage 2 

proposed rule (77 FR 13742). 

We proposed that the reporting period 

for CQMs, which is the period during 

which data collection or measurement 

for CQMs occurs, would continue to 

track with the EHR reporting periods for 

the meaningful use objectives and 

measures: 

• EPs: January 1 through December 31 

(calendar year). 

• Eligible Hospitals and CAHs: 

October 1 through September 30 (federal 

fiscal year). 

• EPs, eligible hospitals, and CAHs in 

their first year of meaningful use for 

Stage 1, any continuous 90-day period 

within the calendar year (CY) or federal 

fiscal year (FY), respectively. 

mstockstill on DSK4VPTVN1PROD with RULES2

54050 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

To avoid a payment adjustment, 

Medicare EPs and eligible hospitals that 

are in their first year of demonstrating 

meaningful use in the year immediately 

preceding any payment adjustment year 

would have to ensure that their 90-day 

EHR reporting period ends at least 3 

months before the end of the CY or FY, 

and that all submission is completed by 

October 1 or July 1, respectively. For 

more information on payment 

adjustments, see section II.D. of this 

final rule. 

The submission period is the time 

during which EPs, eligible hospitals, 

and CAHs may submit CQM 

information. We proposed the 

submission period for CQM data 

generally would be the 2 months 

immediately following the end of the 

EHR reporting period as follows: 

• EPs: January 1 through February 28. 

• Eligible Hospitals and CAHs: 

October 1 through November 30. 

• EPs, eligible hospitals, and CAHs in 

their first year of Stage 1: Anytime after 

the end of their 90-day EHR reporting 

period until the end of the 2 months 

immediately following the end of the 

CY or FY, respectively. However, for 

purposes of avoiding the payment 

adjustments, Medicare EPs and eligible 

hospitals that are in their first year of 

demonstrating meaningful use in the 

year immediately preceding a payment 

adjustment year must submit their CQM 

data no later than October 1 (EPs) or 

July 1 (eligible hospitals) of such 

preceding year. 

Comment: Several commenters stated 

that the first year of a new stage for 

reporting CQMs should only require a 

90-day or 180-day reporting period 

instead of a 365-day reporting period. 

Response: We agree that vendors, EPs, 

eligible hospitals, and CAHs may need 

more time to develop, test, and 

implement EHR technology certified to 

the 2014 Edition EHR certification 

criteria and to be able to meet the CQM 

reporting requirements that we 

proposed beginning in 2014. Therefore, 

for the reasons discussed in this section, 

we are modifying the reporting periods 

for CQMs in 2014 to match the EHR 

reporting periods that we are finalizing 

for 2014. By using 3-month quarters as 

the reporting periods in 2014 for 

providers that are beyond their first year 

of demonstrating meaningful use 

instead of requiring a full year as 

proposed, we allow vendors and health 

care providers as much as 9 months 

more time to program, develop, and 

implement CEHRT, and meet the 

requirements for meaningful use in 

2014. We note that the 3-month quarter 

reporting period is only applicable for 

2014. For 2015 and subsequent years, 

we are finalizing our proposal of a full 

year reporting period for EPs, eligible 

hospitals and CAHs that are beyond 

their first year of demonstrating 

meaningful use. We have selected 3- 

month quarters rather than any 

continuous 90-day period to promote 

more ready comparisons of data. This is 

particularly important for eligible 

hospitals and CAHs since many of the 

CQMs that we are finalizing for 2014 

and subsequent years are also used in 

the CMS Hospital IQR Program. We 

have indicated our desire to transition 

the CMS Hospital IQR Program to 

collecting EHR-based quality data. 

Having data from hospitals for 

comparable quarter timeframes as used 

for the CMS Hospital IQR Program will 

be beneficial for comparing chart 

abstracted data with data derived from 

CEHRT and will facilitate data 

collection mode for potential future 

usage for Hospital Compare public 

reporting and the CMS Hospital Value 

Based Purchasing programs. 

After consideration of the public 

comments received, we are finalizing 

the reporting and submission periods as 

follows. The reporting period for CQMs 

generally will be the same as an EP’s, 

eligible hospital’s, or CAH’s respective 

EHR reporting period for the meaningful 

use objectives and measures, with the 

exceptions discussed later in this 

section. Please note that Medicare EPs 

who choose to report CQMs through the 

options we are finalizing that rely on 

other CMS programs (namely, Option 

2—PQRS (see section II.B.6.c. of this 

final rule) and the group reporting 

options—Physician Quality Reporting 

System (PQRS) and Accountable Care 

Organizations (ACOs) (see section 

II.B.6.d. of this final rule) would be 

subject to the reporting periods for 

CQMs established for those programs. 

As an example using CY 2014, for 

Medicare EPs who choose to submit 

CQMs under Option 2 (PQRS EHR 

Reporting Option) for purposes of 

satisfying the CQM reporting 

component of meaningful use, the 

reporting periods for the PQRS EHR 

reporting that fall within CY 2014 

would apply. Medicaid EPs and eligible 

hospitals must submit CQM data for a 

reporting period that is the same as their 

EHR reporting period using the 

reporting methods and submission 

periods specified by their state 

Medicaid agency. 

In 2013, the reporting period for 

CQMs will continue to be an EP’s, 

eligible hospital’s or CAH’s respective 

EHR reporting period. The submission 

period will be the 2 months 

immediately following the end of the 

CY or FY, respectively (EPs: January 1 

through February 28, 2014; eligible 

hospitals and CAHs: October 1 through 

November 30, 2013). EPs, eligible 

hospitals and CAHs in their first year of 

meaningful use may submit CQM data 

anytime after the end of their 90-day 

EHR reporting period until the end of 

the 2 months immediately following the 

end of the CY or FY, respectively. 

Beginning in 2014 and in subsequent 

years, for EPs, eligible hospitals and 

CAHs that are in their first year of 

meaningful use, the reporting period for 

CQMs will be their respective 90-day 

EHR reporting period, and they must 

submit CQM data by attestation. The 

submission period will be anytime after 

the end of their respective 90-day EHR 

reporting period until the end of the 2 

months immediately following the end 

of the CY or FY, respectively. However, 

for purposes of avoiding a payment 

adjustment, Medicare EPs and eligible 

hospitals that are in their first year of 

demonstrating meaningful use in the 

year immediately preceding a payment 

adjustment year must submit their CQM 

data no later than October 1 (EPs) or 

July 1 (eligible hospitals) of such 

preceding year. We note that these 

deadlines do not apply to CAHs. For 

more details on submission deadlines 

specific to CAHs, please refer to section 

II.D.4. of this final rule. 

Beginning in 2014 and in subsequent 

years, EPs, eligible hospitals and CAHs 

that are beyond their first year of 

meaningful use must electronically 

submit CQM data unless the Secretary 

lacks the capacity to accept electronic 

submission. In the unlikely event that 

the Secretary does not have the capacity 

to accept electronic submission, then 

consistent with sections 1848(o)(2)(B)(ii) 

and 1886(n)(3)(B)(ii) of the Act, we 

would continue to accept attestation as 

a method of reporting CQMs. We would 

inform the public of this fact by 

publishing a notice in the Federal 

Register and providing instructions on 

how CQM data should be submitted to 

us. For additional details on the 

reporting methods for EPs, please refer 

to sections II.B.6.c. and II.B.6.d. of this 

final rule, and for the reporting methods 

for eligible hospitals and CAHs, please 

refer to section II.B.8.b. of this final rule. 

The reporting periods for CQMs in 2014 

for EPs, eligible hospitals, and CAHs 

that are beyond their first year of 

meaningful use are as follows: 

• EPs, eligible hospitals and CAHs 

may report CQM data for the full CY or 

FY 2014, respectively, if desired. 

Alternatively, they may report CQM 

data for the 3-month quarter(s) that is/ 

are their respective EHR reporting 

period. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54051 

++ For EPs, the 3-month quarters are as 

follows: 

—January 1, 2014 through March 31, 

2014 

—April 1, 2014 through June 30, 2014 

—July 1, 2014 through September 30, 

2014 

—October 1, 2014 through December 

31, 2014 

++ For eligible hospitals and CAHs, the 

3-month quarters are as follows: 

—October 1, 2013 through December 

31, 2013 

—January 1, 2014 through March 31, 

2014 

—April 1, 2014 through June 30, 2014 

—July 1, 2014 through September 30, 

2014 

In all cases of electronic submission, 

the submission period will be the 2 

months immediately following the end 

of the CY or FY, respectively. This 

submission period will apply regardless 

of whether an EP, eligible hospital or 

CAH reports CQM data for the full CY 

or FY, respectively, or only for a 3- 

month quarter: 

• EPs: January 1, 2015 through 

February 28, 2015. 

• Eligible Hospitals and CAHs: 

October 1, 2014 through November 30, 

2014. 

The reporting periods for CQMs in 

2015 and in subsequent years for EPs, 

eligible hospitals, and CAHs that are 

beyond their first year of meaningful use 

will be the full CY or FY, respectively. 

For EPs, we expect to accept a single 

annual submission. For eligible 

hospitals and CAHs, we expect to align 

with the submission frequency of the 

Hospital IQR program for electronic 

reporting of CQMs. 

We summarize the reporting and 

submission periods beginning with CY/ 

FY 2014 for EPs, eligible hospitals, and 

CAHs reporting CQMs via attestation in 

Table 5 and reporting CQMs 

electronically in Table 6. 

TABLE 5—REPORTING AND SUBMISSION PERIODS FOR EPS, ELIGIBLE HOSPITALS AND CAHS IN THEIR FIRST YEAR OF

MEANINGFUL USE SUBMITTING CQMS VIA ATTESTATION BEGINNING WITH CY/FY 2014 

Provider type 

Reporting period for first year of 

meaningful use 

(Stage 1) 

Submission period for first year of meaningful use 

(Stage 1)* 

EP ............................................................... 90 consecutive days ................................. Anytime immediately following the end of the 90-day reporting period, but no later than February 28 of the 

following calendar year. 

Eligible Hospital/CAH ................................. 90 consecutive days ................................. Anytime immediately following the end of the 90-day reporting period, but no later than November 30 of the 

following fiscal year. 

*For purposes of avoiding a payment adjustment, Medicare EPs and eligible hospitals that are in their first year of demonstrating meaningful 

use in the year immediately preceding a payment adjustment year must submit their CQM data no later than October 1 (EPs) or July 1 (eligible 

hospitals) of such preceding year. 

TABLE 6—REPORTING AND SUBMISSION PERIODS FOR EPS, ELIGIBLE HOSPITALS AND CAHS BEYOND THEIR FIRST YEAR

OF MEANINGFUL USE SUBMITTING CQMS ELECTRONICALLY BEGINNING WITH CY/FY 2014 

Provider type Optional reporting period in 2014* 

Reporting period for subsequent 

years of meaningful use 

(stage 1 and subsequent stages) 

Submission period for subsequent 

years of meaningful use 

(stage 1 and subsequent stages)* 

EP .................................................. Calendar year quarter: 

January 1–March 31 

April 1–June 30 

July 1–September 30 

October 1–December 31 

1 calendar year (January 1–December 31).2 months following the end of the 

reporting period (January 1– 

February 28). 

Eligible Hospital/CAH ..................... Fiscal year quarter ........................

October 1–December 31 

January 1–March 31 

April 1–June 30 

July 1–September 30 

1 Fiscal year (October 1–September 30).2 months following the end of the 

reporting period (October 1–November 30). 

*NOTE: The optional quarter reporting periods have the same submission period as a full year reporting period for electronic submission. 

2. EHR Technology Certification 

Requirements for Reporting of CQMs 

ONC adopts certification criteria for 

EHR technology and proposed a 2014 

Edition of certification criteria in a 

proposed rule (77 FR 13832). As such, 

we proposed to require that CEHRT, as 

defined by ONC, must be used by EPs, 

eligible hospitals, and CAHs to satisfy 

their CQM reporting requirements (77 

FR 13743). We proposed that CQM 

reporting methods could include the 

following: 

• Aggregate reporting methods (EPs, 

eligible hospitals, and CAHs): 

++ Attestation 

++ Electronic submission 

• Patient-level reporting methods: 

++ The PQRS EHR reporting option, 

the group reporting options for 

PQRS, the Medicare SSP or Pioneer 

ACOs (note: these are reporting 

methods for EPs) 

++ The manner similar to the 2012 

Medicare EHR Incentive Program 

Electronic Reporting Pilot for 

Eligible Hospitals and CAHs. 

For the attestation and aggregate 

electronic reporting methods, we 

proposed that EPs, eligible hospitals, 

and CAHs must only submit CQMs that 

their EHR technology had been certified 

to ‘‘incorporate and calculate’’ (45 CFR 

170.314(c)(2) in ONC’s rule). For 

example, if an EP’s CEHRT was certified 

to calculate CQMs #1 through #9, and 

the EP submitted CQMs #1 through #8 

and #25, the EP would not have met the 

meaningful use requirement for 

reporting CQMs because his/her CEHRT 

was not certified to calculate CQM #25. 

For the attestation and aggregate 

electronic reporting methods, we 

proposed that CEHRT must be certified 

to the ‘‘reporting’’ certification criterion 

proposed for adoption by ONC at 45 

CFR 170.314(c)(3) and which focused on 

mstockstill on DSK4VPTVN1PROD with RULES2

54052 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

EHR technology’s capability to create 

and transmit a standard aggregate XMLbased file that CMS can electronically 

accept. 

Comment: Most commenters 

supported the requirement that EHR 

technology certified to the 2014 Edition 

EHR certification criteria should be able 

to capture, accurately calculate and 

transmit CQM data. Many of these 

commenters pointed out EHR 

technology certified to the 2011 Edition 

EHR certification criteria did not 

produce accurate results and was not 

explicitly tested and certified for 

accurate CQM calculation. As a result of 

experiences in Stage 1, some 

commenters recommended requiring 

that EHR technologies be able to 

calculate all measures finalized by CMS 

in order to be certified rather than 

requiring only one CQM to be certified, 

as was proposed by ONC to satisfy the 

Base EHR definition. Others supported 

EHR technology’s output of data to 

another product for calculation or 

output in the Quality Reporting Data 

Architecture (QRDA) format. Many 

commenters also supported consistency 

among EHR technologies based on 

certification and adequate testing of the 

systems during certification, including 

use of test data. One commenter 

recommended closer oversight of 

vendors by ONC and a remediation 

process for vendors who do not properly 

implement CEHRT. 

Many commenters stated that the 

specific XML-based format required by 

CMS for CQM reporting should be 

incorporated into ONC’s certification 

criteria. One commenter suggested that 

all vendors focus on codified data 

collection and provide complete CCD 

extractions to another system (such as 

PopHealth) and allow that system to 

manage the calculations and data tables 

as well as provide the extraction of data 

for a QRDA report, stating that this 

method would save time and money 

because it would not require testing 

each individual EHR product. Another 

commenter supported the use of CQM 

definitions that include standards for 

technical and electronic specifications 

that allow for interoperability across 

EHRs and consistent use among end 

users. 

Response: Comments on EHR 

technology certification requirements 

are outside the scope of this final rule 

and are addressed in ONC’s Standards 

and Certification Criteria (S&CC) final 

rule published elsewhere in this issue of 

the Federal Register. ONC has 

addressed the CQM requirements for the 

Base EHR definition, the standards 

necessary for the submission of CQM 

data to CMS, and has made other 

conforming revisions to the proposed 

certification criteria in response to 

public comments received. 

Comment: Several commenters stated 

that it was unrealistic to expect the 

transition to EHR technology certified to 

the 2014 Edition EHR certification 

criteria to be feasible for all EPs and all 

eligible hospitals and CAHs at the same 

time. These commenters explained that 

EHR vendors would need to develop, 

test, distribute upgraded products, and 

provide user support for a large number 

of clients in a short amount of time. 

Furthermore, EPs, eligible hospitals, and 

CAHs would need to devote time and 

resources as well as have qualified staff 

to purchase and implement the 

upgraded technology, including testing 

the system and training staff, which may 

include designing new clinical 

workflows. The commenters requested a 

more reasonable approach to 

transitioning to the upgraded 

technology that would ensure proper 

implementation and avoid 

compromising patient safety. 

Response: We acknowledge that the 

transition to upgraded EHR technology 

will be a challenge for all parties 

involved. Due to several interrelated 

factors addressed by ONC and CMS to 

relieve regulatory burden in our 

respective final rules, we have 

respectively included certain new 

flexibilities for EPs, eligible hospitals, 

and CAHs in order to allow for a more 

reasonable transition to the upgraded 

technology. ONC has decided to finalize 

a more flexible CEHRT definition for the 

EHR reporting periods in FY/CY 2013, 

which would permit EPs, eligible 

hospitals, and CAHs to use EHR 

technology that has been certified only 

to the 2014 Edition EHR certification 

criteria. 

For EPs, eligible hospitals, and CAHs 

that seek to use EHR technology 

certified only to the 2014 Edition EHR 

certification criteria in FY/CY 2013, we 

note that EHR technology certified to 

these criteria reflect the new set of 

CQMs we adopt in this rule for 

reporting beginning with FY/CY 2014. 

We also note that the reporting 

requirements in FY/CY 2013 are 

otherwise the same as for FY/CY 2011 

and 2012, including reporting on the 

CQMs that were finalized in the July 28, 

2010 Stage 1 final rule. For EPs, the 

reporting schema for CY 2013 will 

remain 3 core or alternate core CQMs, 

and 3 additional CQMs, as explained in 

section II.B.5.b. of this final rule. We 

note that EHR technology certified to 

the 2014 Edition certification criteria 

will exclude the three CQMs that we are 

removing from the list of EP CQMs for 

reporting beginning in CY 2014 (NQF 

0013, 0027, 0084). NQF 0013 is in the 

list of core CQMs in the Stage 1 final 

rule, but just as in the case where one 

of the core CQMs would not apply to an 

EP’s scope of practice or unique patient 

population, EPs can select one CQM 

from the list of alternate core CQMs to 

replace NQF 0013. Therefore, in order to 

meet the CQM reporting criteria for 

meaningful use in CY 2013, EPs who 

seek to use EHR technology certified 

only to the 2014 Edition EHR 

certification criteria could only select 

from CQMs that are included in both the 

Stage 1 and Stage 2 final rules. For 

eligible hospitals and CAHs, the 

reporting schema for FY 2013 will 

remain all 15 of the CQMs finalized for 

reporting in FYs 2011 and 2012 because 

all CQMs that were included in the 

Stage 1 final rule are also included in 

the Stage 2 final rule. 

Comment: Most commenters stated 

that CQM exceptions (allowable reason 

for non-performance of a quality 

measure for patients that meet the 

denominator criteria and do not meet 

the numerator criteria) should be 

incorporated into the CQM certification 

requirements. Many commenters also 

stated that EPs should not be penalized 

if it is later determined that a vendor 

has not met the certification 

requirement as it would be burdensome 

and expensive to then purchase 

additional certified modules and modify 

workflows after an existing EHR is 

determined to be non-certified. The 

same commenters believed that EPs 

should have an exemption from CQM 

reporting requirements of meaningful 

use until measures have been tested and 

vendors have shown they have met the 

certification requirements. 

Some commenters requested delaying 

implementation of CQMs that require 

information from Labor and Delivery 

information systems until they are 

certified. One commenter stated that 

EHR technology should be based on the 

2011 Edition EHR certification criteria. 

Another commenter stated that very few 

vendors are providing QI measure data 

integrity and error-checking algorithms, 

citing the information in FAQ 10839 

which includes that CMS does not 

require providers to record all clinical 

data in their CEHRT but that providers 

should report the CQM data exactly as 

it is generated as output from CEHRT. 

Response: We do not agree with the 

suggestion that EHR technology should 

based on the 2011 Edition EHR 

certification criteria. The 2014 Edition 

EHR certification criteria are 

significantly enhanced compared to 

2011 Edition and we believe that it is 

important for EPs, eligible hospitals and 

CAHs to adopt, implement, and use 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54053 

EHR technology based on the updated 

certification criteria. We expect that the 

enhancements in the 2014 Edition 

certification criteria will address the 

accuracy of outputs from CEHRT. 

We agree generally with the rest of the 

comments. All CQMs included in this 

final rule will have electronic 

specifications available at or around the 

time of publication. Certification 

requirements are outside the scope of 

this rule. We refer readers to ONC’s 

S&CC final rule published elsewhere in 

this issue of the Federal Register for 

information of certification 

requirements for items such as CQM 

exceptions. We discuss the testing of 

CQM specifications in section II.B.4. of 

this final rule. We encourage EPs, 

eligible hospitals and CAHs to refer to 

the Certified HIT Products List when 

selecting an EHR product (http:// 

oncchpl.force.com/ehrcert). We also 

encourage EPs, eligible hospitals, and 

CAHs to discuss their intent to 

participate in the EHR Incentive 

Programs with their vendors, and for 

vendors to communicate intentions 

related to certification of a product with 

EPs, eligible hospitals or CAHs. 

After consideration of the public 

comments received, we are finalizing 

the proposals related to EHR technology 

certification requirements for reporting 

of CQMs subject to the discussion 

earlier. They include: 

• The data reported to CMS for CQMs 

must originate from an EP’s, eligible 

hospital’s, or CAH’s CEHRT that has 

been certified to ‘‘capture and export’’ 

in accordance with 45 CFR 170.314(c)(1) 

and ‘‘electronic submission’’ in 

accordance with 45 CFR 170.314(c)(3). 

• For attestation and the aggregate 

electronic reporting methods, the only 

CQMs that can be reported are those for 

which an EP’s, eligible hospital’s, or 

CAH’s CEHRT has been certified to 

‘‘import and calculate’’ in accordance 

with 45 CFR 170.314(c)(2). 

• In FY/CY 2013, if an EP, eligible 

hospital, or CAH seeks to use EHR 

technology certified only to the 2014 

Edition EHR certification criteria for 

reporting CQMs, they can only report 

those CQMs that are included in both 

the Stage 1 and Stage 2 final rules. For 

EPs, this would exclude the option of 

reporting NQF 0013, 0027, 0084 from 

the CQMs in the Stage 1 final rule. Since 

NQF 0013 is a core CQM in the Stage 

1 final rule, EPs would select one of the 

alternate core CQMs to replace it. All 15 

CQMs for eligible hospitals and CAHs in 

the Stage 1 final rule are included in the 

Stage 2 final rule. 

3. Criteria for Selecting CQMs 

We solicited comment on a wideranging list of 125 potential CQMs for 

EPs and 49 potential CQMs for eligible 

hospitals and CAHs. We stated that we 

expected to finalize only a subset of 

these proposed CQMs. We discussed 

several criteria that we used to select the 

proposed CQMs. 

In the proposed rule, we stated our 

commitment to align quality 

measurement and reporting among our 

programs (for example, IQR, PQRS, 

CHIPRA, ACO programs). We noted that 

our alignment efforts focus on several 

fronts including using the same 

measures for different programs, 

standardizing the measure development 

and electronic specification processes 

across CMS programs, coordinating 

quality measurement stakeholder 

involvement efforts, and identifying 

ways to minimize multiple submission 

requirements and mechanisms. In the 

proposed rule, we gave the example that 

we are working toward allowing CQM 

data submitted via CEHRT by EPs, 

eligible hospitals and CAHs to apply to 

other CMS quality reporting programs. 

A longer-term vision would be hospitals 

and clinicians reporting through a 

single, aligned mechanism for multiple 

CMS programs. We stated our belief that 

the alignment options proposed for 

PQRS/EHR Incentive Program would be 

a first step toward such a vision. 

Comment: There was strong support 

for aligning CQMs and reporting 

mechanisms across multiple quality 

reporting programs as well as alignment 

with the goals of the National Quality 

Strategy and the HIT Policy Committee 

recommendations. However, some 

commenters addressed utility of the 

CQMs within the EHR Incentive 

Program as follows: 

• Removal of measures that are not 

included under other quality reporting 

programs. 

• Alignment in other areas such as 

specifications, reporting methods and to 

whom measures are reported. 

• Concern that the penalties that will 

be applied in 2015, given the many 

problems that were encountered 

implementing Stage 1 CQMs. 

• Administrative burden required by 

multiple submission requirements and 

multiple reporting mechanisms. Where 

possible, one commenter encouraged 

CMS to promote and/or mandate similar 

action for state, accreditation body, and 

private payer reporting. 

Response: We appreciate the 

comments received and have made 

every effort to accommodate the 

concerns by aligning quality reporting 

for EPs with the PQRS EHR Reporting 

Option and establishing an 

infrastructure for eligible hospitals and 

CAHs that could be used by IQR and 

other hospital reporting programs to 

electronically report CQMs. 

We continue to explore how data 

intermediaries and state Medicaid 

Agencies could participate in and 

further enable these quality 

measurement and reporting alignment 

efforts, while meeting the needs of 

multiple Medicare and Medicaid 

programs (for example, ACO programs, 

Dual Eligible initiatives, Medicaid 

shared savings efforts, CHIPRA and 

Affordable Care Act measure sets). 

Through these efforts, we intend to 

lessen provider burden and harmonize 

with our data exchange priorities. 

In addition to statutory requirements 

for EPs (see section II.B.5.a. of this final 

rule), eligible hospitals (see sections 

II.B.7.a. of this final rule), and CAHs 

(see section II.B.7.a. of this final rule), 

we relied on other criteria to select the 

proposed CQMs for EPs, eligible 

hospitals, and CAHs such as measures 

that can be technically implemented 

within the capacity of the CMS 

infrastructure for data collection, 

analysis, and calculation of reporting 

and performance rates. This includes 

measures that are ready for 

implementation, such as those with 

developed specifications for electronic 

submission that have been used in the 

EHR Incentive Program or other CMS 

quality reporting initiatives, or that will 

be ready soon after the expected 

publication of the final rule in 2012. 

This also includes measures that can be 

most efficiently implemented for data 

collection and submission. 

Comment: There were several 

comments on infrastructure regarding 

quality measures, the selection of 

quality measures, challenges of 

implementing EHRs and the lack of 

coordination between measure 

developers and software vendors. These 

comments included the following: 

• CQMs require data that is not coded 

in a structured format within the EHRs 

and thus require significant resources 

and effort, including specialized coding 

and training, in order to build CQMs 

within the EHR systems that can 

produce accurate results. 

• CMS should only include measures 

which have been sufficiently field tested 

and validated. The National Qualify 

Forum’s (NQF) Quality Data Model 

(QDM) and Measure Authoring Tool 

(MAT) have not been sufficiently tested 

to ensure valid and accurate EHR CQM 

calculations. 

• A general lack of communication 

between vendors and measure stewards. 

mstockstill on DSK4VPTVN1PROD with RULES2

54054 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

There were also several comments 

providing additional recommendations 

for selecting quality measures, including 

CQMs that: 

• Can be automatically abstracted 

from an EHR. 

• Rely on data that is considered 

viable and accurate. 

• Definitively support quality care 

improvement. 

• Align with current quality 

programs. 

Response: The CQMs that we are 

finalizing for reporting beginning with 

2014 have either undergone feasibility 

testing in EHR systems and clinical 

settings or were finalized in the Stage 1 

final rule for reporting in 2011 and 2012 

and specifications have been updated 

based on experiences with reporting 

those CQMs. In addition, ONC’s 2014 

Edition certification criteria explicitly 

require that the data elements be 

captured for certification (see 45 CFR 

170.314(c), as discussed in ONC’s final 

rule). We have taken into account the 

recommendations of commenters in our 

selection of the CQMs finalized for 

reporting beginning in 2014, and we are 

finalizing measures that align with 

current clinical quality programs as well 

as definitively support quality care 

improvements. 

Comment: Commenters pointed out 

the limitations of current CQMs in 

addressing longitudinal patient care 

management and population health. 

Response: We are finalizing CQMs for 

EPs, eligible hospitals, and CAHs that 

will have electronic specifications 

available at or around the time of 

publication of the final rule and also 

meet the selection criteria described in 

this rule. We agree with the importance 

of the clinical quality measurement 

goals mentioned by the commenters and 

are working with measure stewards and 

measure developers to create a broader 

set of electronic CQMs that would 

address these goals. 

We also identified the following as 

criteria used in selecting CQMs: 

• CQMs that can be technically 

implemented within the capacity of the 

CMS infrastructure for data collection, 

analysis, and calculation of reporting 

and performance rates. This includes 

CQMs that are ready for 

implementation, such as those with 

developed specifications for electronic 

submission that have been used in the 

EHR Incentive Program or other CMS 

quality reporting initiatives, or that will 

be ready soon after the expected 

publication of the final rule in 2012. 

This also includes CQMs that can be 

most efficiently implemented for data 

collection and submission. 

• CQMs that support CMS and HHS 

priorities for improved quality of care 

for people in the United States, which 

are based on the March 2011 report to 

the Congress, ‘‘National Strategy for 

Quality Improvement in Health Care’’ 

(National Quality Strategy, NQS) 

(http://www.healthcare.gov/law/ 

resources/reports/nationalquality

strategy032011.pdf) and the Health 

Information Technology Policy 

Committee’s (HITPC’s) 

recommendations (http://healthit.hhs.

gov/portal/server.pt?open=512&objID=

1815&parentname=CommunityPage&

parentid=7&mode=2&in_hi_userid=

11113&cached=true). 

• CQMs that address known gaps in 

quality of care, such as measures in 

which performance rates are currently 

low or for which there is wide 

variability in performance, or that 

address known drivers of high 

morbidity and/or cost for Medicare and 

Medicaid. 

• CQMs that address areas of care for 

different types of EPs (for example, 

Medicare- and Medicaid-eligible 

physicians, and Medicaid-eligible 

nurse-practitioners, certified nursemidwives, dentists, physician 

assistants). 

In an effort to align the CQMs used 

within the EHR Incentive Program with 

the goals of CMS and HHS, the NQS, 

and the HITPC’s recommendations, we 

have assessed all proposed CQMs 

against six domains based on the NQS’s 

six priorities, which were further 

developed by the HITPC Workgroups, as 

follows: 

• Patient and Family Engagement. 

These are CQMs that reflect the 

potential to improve patient-centered 

care and the quality of care delivered to 

patients. They emphasize the 

importance of collecting patientreported data and the ability to impact 

care at the individual patient level as 

well as the population level through 

greater involvement of patients and 

families in decision making, self care, 

activation, and understanding of their 

health condition and its effective 

management. 

• Patient Safety. These are CQMs that 

reflect the safe delivery of clinical 

services in both hospital and 

ambulatory settings and include 

processes that would reduce harm to 

patients and reduce burden of illness. 

These measures should enable 

longitudinal assessment of conditionspecific, patient-focused episodes of 

care. 

• Care Coordination. These are CQMs 

that demonstrate appropriate and timely 

sharing of information and coordination 

of clinical and preventive services 

among health professionals in the care 

team and with patients, caregivers, and 

families in order to improve appropriate 

and timely patient and care team 

communication. 

• Population and Public Health. 

These are CQMs that reflect the use of 

clinical and preventive services and 

achieve improvements in the health of 

the population served and are especially 

focused on the leading causes of 

mortality. These are outcome-focused 

and have the ability to achieve 

longitudinal measurement that will 

demonstrate improvement or lack of 

improvement in the health of the US 

population. 

• Efficient Use of Healthcare 

Resources. These are CQMs that reflect 

efforts to significantly improve 

outcomes and reduce errors. These 

CQMs also impact and benefit a large 

number of patients and emphasize the 

use of evidence to best manage high 

priority conditions and determine 

appropriate use of healthcare resources. 

• Clinical Processes/Effectiveness. 

These are CQMs that reflect clinical care 

processes closely linked to outcomes 

based on evidence and practice 

guidelines. 

We solicited comments on these 

domains, and whether they would 

adequately align with and support the 

breadth of CMS and HHS activities to 

improve quality of care and health 

outcomes. 

Comment: Many commenters 

supported the NQS initiative. Many 

commenters stated that the domains 

were imprecise and some CQMs can be 

placed in multiple domains. Some 

commenters recommended that the Care 

Coordination domain include pre- and 

post-acute care providers and that the 

CQMs be carefully assigned to the 

appropriate domains. 

Response: We appreciate the 

supportive comments with respect to 

the NQS. We agree with commenters 

that certain CQMs do not fit in only a 

single domain. When we considered 

CQMs for selection, we also considered 

to what extent a domain is already 

represented in the meaningful use 

objectives and measures, which use 

performance thresholds. For example, in 

the area of care coordination, to be a 

meaningful EHR user, a provider must 

provide a summary of care record for 

more than 50 percent of their transitions 

of care and referrals. In addition, in the 

area of patient and family engagement, 

to be a meaningful EHR user a provider 

must make patients’ health information 

available to them and potentially their 

caregivers and families and is 

responsible for ensuring that at least 5 

percent of their patients or their 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54055 

caregivers and families actually access 

that information. For these reasons, we 

are relaxing the requirement to report 

CQMs in each domain as discussed in 

section II.B.5.c. of this final rule for EP 

reporting requirements and II.B.7.c. of 

this final rule for eligible hospital and 

CAH reporting requirements. 

We stated in the proposed rule that 

we also considered the 

recommendations of the Measure 

Applications Partnership (MAP) for 

inclusion of CQMs. The MAP is a 

public-private partnership convened by 

the National Quality Forum (NQF) for 

the primary purpose of providing input 

to HHS on selecting performance 

measures for public reporting. The MAP 

published draft recommendations in 

their Pre-Rulemaking Report on January 

11, 2012 (http://www.qualityforum.org/ 

map/), which includes a list of, and 

rationales for, all the CQMs that the 

MAP did not support. The MAP did not 

review the CQMs for 2011 and 2012 that 

were previously adopted for the EHR 

Incentive Program in the Stage 1 final 

rule. We stated in the proposed rule that 

we included some of the CQMs not 

supported by the MAP in Tables 7 (EPs) 

and 8 (eligible hospitals and CAHs) to 

ensure alignment with other CMS 

quality reporting programs, address 

recommendations by other Federal 

advisory committees such as the HITPC, 

and support other quality goals such as 

the Million Hearts Campaign. We also 

stated that we included some CQMs to 

address specialty areas that may not 

have had applicable CQMs in the Stage 

1 final rule. 

We stated in the proposed rule that 

we anticipated that only a subset of 

these CQMs would be finalized. We 

stated that in considering which 

measures to finalize, we would take into 

account public comment on the CQMs 

themselves and the priorities listed 

previously. We also stated that we 

intended to prioritize CQMs in order to 

align with and support to the extent 

possible the measurement needs of CMS 

program activities related to quality of 

care, delivery system reform, and 

payment reform, especially the 

following: 

• Encouraging the use of outcome 

measures, which provide foundational 

data needed to assess the impact of 

these programs on population health. 

• Measuring progress in preventing 

and treating priority conditions, 

including those affecting a large number 

of CMS beneficiaries or contributing to 

a large proportion of program costs. 

• Improving patient safety and 

reducing medical harm. 

• Capturing the full range of 

populations served by CMS programs. 

Comment: Several commenters 

support the inclusion of CQMs 

recommended by the MAP. A 

commenter supported CQMs which are 

both MAP evaluated and NQF endorsed. 

Another commenter raised concern that 

CMS did not have enough time to 

consider the MAP recommendations as 

the CQMs published in the proposed 

rule differ from those recommended by 

the MAP. Some commenters were 

concerned that limiting the CQMs to 

MAP-supported and/or NQF-endorsed 

CQMs would discourage CQM 

innovation and the creation of novel 

CQMs and those that cover more 

specialties. 

Response: We carefully considered 

the MAP recommendations and took 

NQF endorsement status into 

consideration when making our CQM 

selections for reporting beginning with 

2014. In order to align with other 

quality reporting programs and address 

recommendations by other Federal 

advisory committees, such as the 

HITPC, as well as consider CQMs 

endorsed by other multistakeholder 

groups, we considered CQMs that were 

not supported by the MAP. After 

consideration of the public comments 

received, we are finalizing the policies 

on criteria for selecting CQMs as 

proposed. 

4. CQM Specification 

We stated in the proposed rule that 

we do not intend to use notice and 

comment rulemaking as a means to 

update or modify CQM specifications. 

In general, it is the role of the measure 

steward to make changes to a CQM in 

terms of the initial patient population, 

numerator, denominator, and potential 

exclusions. We recognized that it may 

be necessary to update CQM 

specifications after they have been 

published to ensure their continued 

relevance, accuracy, and validity. 

Measure specifications updates may 

include administrative changes, such as 

adding the NQF endorsement number to 

a CQM, correcting faulty logic, adding 

or deleting codes as well as providing 

additional implementation guidance for 

a CQM. 

These changes would be described in 

full through supplemental updates to 

the electronic specifications for EHR 

submission provided by CMS. We stated 

that measures would be tracked on a 

version basis as updates to those CQMs 

are made, and we would require EPs, 

eligible hospitals, and CAHs to submit 

the versions of the CQMs as identified 

on our Web site. 

We stated in the proposed rule that 

the complete CQM specifications would 

be posted on our Web site (https:// 

www.cms.gov/QualityMeasures/ 

03_ElectronicSpecifications.asp) at or 

around the time of the final rule. In 

order to assist the public in considering 

the proposed CQMs, we published 

tables titled ‘‘Proposed CQMs for 2014 

CMS EHR Incentive Programs for 

Eligible Professionals’’ and ‘‘Proposed 

CQMs for 2014 CMS EHR Incentive 

Programs for Eligible Hospitals and 

CAHs’’ on this Web site. These tables 

contain additional information for the 

EP, eligible hospital, and CAH CQMs, 

respectively, which may not be found 

on the NQF Web site. We noted that 

some of the CQMs were still being 

developed and that the additional 

descriptions provided in the tables may 

still change before the final rule is 

published. We noted that the titles and 

descriptions for the CQMs included in 

these tables were updated by the 

measure stewards and therefore may not 

match the information provided on the 

NQF Web site. 

We proposed that, under certain 

circumstances, it may be necessary to 

remove a CQM from the EHR Incentive 

Programs between rulemaking cycles. 

We stated in the proposed rule that 

when there is reason to believe the 

continued collection of a CQM as it is 

currently specified raises potential 

patient safety concerns and/or is no 

longer scientifically valid, we would 

take immediate action to remove the 

CQM from the EHR Incentive Programs 

and not wait for the next rulemaking 

cycle. Likewise, we stated if a CQM 

undergoes a substantive change by the 

measure steward between rulemaking 

cycles such that the measure’s intent 

has changed, we would remove the 

measure immediately from the EHR 

Incentive Programs until the next 

rulemaking cycle when we could 

propose the revised CQM for public 

comment. Under this proposed policy, 

we would promptly remove such CQMs 

from the set of CQMs available for EPs 

or eligible hospitals and CAHs to report 

under the EHR Incentive Programs, 

confirm the removal or propose the 

revised CQM, in the next EHR Incentive 

Programs rulemaking cycle, and notify 

providers (EPs, eligible hospitals, and 

CAHs) and the public of our decision to 

remove the CQM(s) through the usual 

communication channels (memos, email 

notification, web site postings). 

Comment: Numerous commenters 

indicated the importance of having 

CQM specifications and implementation 

guides as soon as possible. Several 

commenters pointed out that CQMs 

without electronic specifications should 

be re-tooled as eMeasures prior to 

inclusion in meaningful use. 

mstockstill on DSK4VPTVN1PROD with RULES2

54056 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

Response: We will provide complete 

CQM specifications at or around the 

time of the publication of this final rule 

on our Web site (https://www.cms.gov/ 

Medicare/Quality-Initiatives-PatientAssessment-Instruments/Quality

Measures/Electronic

Specifications.html). All of the CQMs 

that we are finalizing will be fully 

specified. 

Comment: Many commenters noted 

that more than 6 months is needed to 

deploy and adequately test upgrades 

that may affect clinician workflows and 

patient safety. Other commenters stated 

that software developers need at least 18 

to 24 months to alter their systems and 

allow for installation of software to 

complete process updates, development, 

testing, error checks, training, and rollout before the reporting periods begin. 

Multiple commenters requested 

notification and a scheduled approach 

to making changes to CQM 

specifications. Commenters suggested 

that CMS post the CQMs and updates in 

one place for easy reference. 

Response: We understand health care 

providers and software developers need 

sufficient time to accommodate CQM 

specification updates. However, we 

must balance this with our policy 

priority for CQMs to remain consistent 

with clinical practice guidelines and 

any new scientific data related to 

efficacy. To address the timing concerns 

mentioned by commenters, we expect to 

make the updated specifications, which 

will be tracked on a version basis, 

publicly available through our Web site 

(https://www.cms.gov/Medicare/ 

Quality-Initiatives-Patient-AssessmentInstruments/QualityMeasures/ 

ElectronicSpecifications.html) 

approximately 6 months in advance of 

the beginning of the CY and FY for EPs 

and hospitals, respectively. We will 

make every effort to have updated 

specifications made available earlier 

and ensure that measure updates are 

limited in scope. In the event that we 

remove CQMs between rulemakings, we 

will post this information on the same 

Web site and notify the public through 

listserv and any additional 

communication channels that may be 

appropriate. 

Comment: Many commenters stated 

that CQM specifications should not 

have to be updated in CEHRT during the 

period for which the EHR product is 

certified. Some commenters pointed out 

the burden and complexity of 

supporting multiple versions of the 

CQMs concurrently (that is, the 

specifications authorized for use within 

the current reporting period, and the 

updated specifications intended for 

implementation in the following 

reporting period). 

Response: CQM specifications are 

updated to maintain alignment with 

current clinical guidelines and ensure 

that the CQM remains relevant and 

actionable within the clinical care 

setting. We believe the benefits of 

having the ability to update 

specifications more frequently than the 

rulemaking cycle for the EHR Incentive 

Programs outweighs the burden and 

complexity identified by commenters. 

As a result of aligning with other 

quality reporting programs (for example, 

PQRS), the CQMs and specifications are 

being used in multiple programs. If we 

do not have the ability to update 

specifications annually, then our 

respective programs may no longer 

align. Furthermore, without having the 

ability to update the specifications at 

least annually, the CQMs could become 

obsolete and would not adequately 

reflect current best practices. The 

majority of the administrative changes 

expected in the annual specification 

updates would reflect updates that 

vendors would routinely push to their 

clients’ EHR technologies (for example, 

drug code updates). 

We did not receive any comments on 

our proposed policy to remove CQMs 

between rulemaking cycles under 

certain circumstances. 

After consideration of the public 

comments received, we are finalizing 

the following policies on CQM 

specifications. Updates to CQM 

specifications may be provided annually 

approximately 6 months in advance of 

the FY/CY for hospitals and EPs, 

respectively. Providers will not be 

required to use the updated 

specifications for purposes of 

submitting the CQMs for the EHR 

Incentive Program unless specified in 

future rulemaking. We note that EPs 

choosing to submit CQMs through 

another quality reporting program (for 

example, PQRS) would need to use the 

updated specifications if required by the 

other program. We are finalizing the 

policy on removing CQMs between 

rulemaking cycles under certain 

circumstances as proposed. In the event 

that one or more CQMs are removed 

between rulemakings, the number of 

CQMs that an EP, eligible hospital, or 

CAH must report would be reduced by 

the number of CQMs removed. For 

example, if one EP CQM was removed 

from the set of CQMs finalized for EPs 

in Table 7, EPs would only be required 

to submit 8 CQMs instead of 9. 

Likewise, if a hospital CQM is removed 

from the set of CQMs finalized in Table 

8, eligible hospitals and CAHs would 

only be required to submit 15 CQMs 

instead of 16. The requirement that the 

CQMs submitted cover at least 3 

domains will remain the same unless all 

CQMs for a particular domain have been 

eliminated. EPs that are not affected by 

such a removal of a CQM between 

rulemakings and could report on other 

CQMs are expected to continue 

reporting on 9 CQMs. Likewise, eligible 

hospitals and CAHs that are not affected 

and could report on other CQMs are 

expected to continue reporting on 16 

CQMs. 

5. CQMs for EPs 

(a) Statutory and Other Considerations 

Sections 1848(o)(2)(A)(iii) and 

1903(t)(6)(C) of the Act provide for the 

reporting of CQMs by EPs as part of 

demonstrating meaningful use of 

CEHRT. For further explanation of the 

statutory requirements, we refer readers 

to the discussion in our proposed and 

final rules for Stage 1 (75 FR 1870 

through 1902 and 75 FR 44380 through 

44435, respectively). 

Under sections 1848(o)(1)(D)(iii) and 

1903(t)(8) of the Act, the Secretary must 

seek, to the maximum extent 

practicable, to avoid duplicative 

requirements from federal and state 

governments for EPs to demonstrate 

meaningful use of CEHRT under 

Medicare and Medicaid. Therefore, to 

meet this requirement, we continued 

our practice from Stage 1 of proposing 

CQMs that would apply for both the 

Medicare and Medicaid EHR Incentive 

Programs, as listed in sections II.B.5.b. 

and II.B.5.c. of this final rule. 

Section 1848(o)(2)(B)(iii) of the Act 

requires that in selecting CQMs for EPs, 

and in establishing the form and manner 

of reporting, the Secretary shall seek to 

avoid redundant or duplicative 

reporting otherwise required, including 

reporting under subsection (k)(2)(C) 

(that is, reporting under the PQRS). 

Consistent with that requirement, we 

proposed to select CQMs for EPs for the 

EHR Incentive Programs that align with 

other quality reporting programs 

mentioned in the proposed rule (77 FR 

13745). We stated in the proposed rule 

that when a CQM is included in more 

than one CMS quality reporting program 

and is reported using CEHRT, we would 

seek to avoid requiring EPs to report the 

same CQM to separate programs through 

multiple transactions or mechanisms. 

Section 1848(o)(2)(B)(i)(I) of the Act 

requires the Secretary to give preference 

to CQMs endorsed by the entity with a 

contract with the Secretary under 

section 1890(a) (namely, the NQF). We 

proposed CQMs for EPs for 2013, 2014, 

and 2015 (and potentially subsequent 

years) that reflect this preference, 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54057 

although we note that the Act does not 

require the selection of NQF endorsed 

CQMs for the EHR Incentive Programs. 

CQMs listed in this final rule that do not 

have an NQF identifying number are not 

NQF endorsed, but are included in this 

final rule with the intent of eventually 

obtaining NQF endorsement of those 

CQMs determined to be critical to our 

program. 

We stated our intent to increase the 

total number of CQMs for EPs to include 

areas such as behavioral health, dental 

care, long-term care, special needs 

populations, and care coordination. We 

proposed new pediatric CQMs, an 

obstetric CQM, behavioral/mental 

health CQMs, CQMs related to HIV 

medical visits and antiretroviral 

therapy, two oral health CQMs, as well 

as other CQMs that address NQS goals. 

Although we did not propose additional 

CQMs in the areas of long-term and 

post-acute care due to the lack of 

electronic specifications, we stated that 

we would continue to develop or 

identify CQMs for these areas for future 

years. We received public comments 

related to statutory and other 

considerations. We have responded to 

those comments in later sections of this 

final rule, including comments related 

to form and manner and the clinical 

areas covered by specific CQMs (see 

sections II.B.6.c. or II.B.6.d. of this final 

rule). 

(b) CQMs for EPs for CY 2013 

We proposed that for the EHR 

reporting periods in CY 2013, EPs must 

submit data for the CQMs that were 

finalized in the Stage 1 final rule for 

CYs 2011 and 2012 (75 FR 44398 

through 44411, Tables 6 and 7). We 

stated that we expected to post updates 

to the CQMs’ electronic specifications 

on the EHR Incentive Program Web site 

at least 6 months prior to the start of CY 

2013. As required by the Stage 1 final 

rule, EPs must report on 3 core or 

alternate core CQMs, plus 3 additional 

CQMs. We referred readers to the 

discussion in the Stage 1 final rule for 

further explanation of the requirements 

for reporting those CQMs (75 FR 44398 

through 44411). 

We received no public comments and 

are finalizing these proposals for EPs for 

CY 2013. We have posted updates to the 

CQM specifications on the EHR 

Incentive Program Web site (https:// 

www.cms.gov/apps/ama/

license.asp?file=/QualityMeasures/ 

Downloads/QMEPSupplemental.zip) 

and note that they will be optional with 

respect to CY 2013 reporting. 

(c) CQMs and Reporting Options for EPs 

Beginning with CY 2014 

(i) Reporting Options 

We proposed two reporting options 

that would begin in CY 2014 for 

Medicare and Medicaid EPs, as 

described as follows: Options 1 and 2. 

We proposed the CQMs listed in Table 

8 of the proposed rule (77 FR 13749 

through 13757) for all EPs (Medicare 

and Medicaid) for the EHR reporting 

periods in CYs 2014, 2015, and 

potentially subsequent years, regardless 

of whether an EP is in Stage 1 or Stage 

2 of meaningful use. We stated that the 

policies and CQMs proposed for CYs 

2014 and 2015 would continue to apply 

in CY 2016 and subsequent years until 

a new rule is published. Therefore, we 

referred to CQMs that apply ’’beginning 

with’’ or ’’beginning in’’ CY 2014. We 

stated that for Medicaid EPs, although 

the reporting method for CQMs may 

vary by state, the set of CQMs from 

which to select would be the same as for 

Medicare EPs. We stated that Medicare 

EPs who are in their first year of Stage 

1 may report CQMs by attestation. 

For Option 1, we proposed two 

alternatives (Options 1a and 1b), but 

stated that we intended to finalize only 

a single method. We proposed that 

Medicare EPs who participate in both 

the PQRS EHR reporting option and the 

EHR Incentive Program may choose 

Option 2 instead of Option 1. 

• Option 1a: We proposed that EPs 

would select and report 12 CQMs from 

those listed in Table 8 of the proposed 

rule (77 FR 13749 to 13757), including 

at least 1 CQM from each of the 6 

domains, which are described in section 

II.B.3. of this final rule. EPs would 

select the CQMs that best apply to their 

scope of practice and/or unique patient 

population. If an EP’s CEHRT does not 

contain patient data for at least 12 

CQMs, then the EP must report the 

CQMs for which there is patient data 

and report the remaining required 

CQMs as ’’zero denominators’’ as 

displayed by the EPs CEHRT. If there 

are no CQMs applicable to the EP’s 

scope of practice or unique patient 

populations, EPs must still report 12 

CQMs even if zero is the result in either 

the numerator and/or the denominator 

of the CQM. If all applicable CQMs have 

a value of zero from their CEHRT, then 

EPs must report any 12 of the CQMs. We 

noted one advantage of this approach is 

that EPs can choose CQMs that best fit 

their practice and patient populations. 

However, because of the large number of 

CQMs to choose from, this approach 

would result in fewer EPs reporting on 

any given CQM, and likely only a small 

sample of patient data represented in 

each CQM. We proposed that EPs would 

submit the CQM data in an XML-based 

format on an aggregate basis reflective of 

all patients without regard to payer. 

• Option 1b: We proposed that EPs 

would report 11 ‘‘core’’ CQMs listed in 

Table 6 of the proposed rule (77 FR 

13746 to 13747), plus 1 ‘‘menu’’ CQM 

from Table 8 of the proposed rule (77 FR 

13749 to 13757). We noted that the 

’’core’’ CQM set reflected the national 

priorities outlined in section II.B.3. of 

the proposed rule. EPs would select 1 

CQM to report from the ‘‘menu’’ set 

based on their respective scope of 

practice and/or unique patient 

population. We explained one 

advantage of this approach is that 

quality data would be collected on a 

smaller set of CQMs, so the resulting 

data for each CQM would represent a 

larger number of patients and therefore 

could be more accurate. However, this 

approach could mean that more CQMs 

are reported with zero denominators (if 

they are not applicable to certain 

practices or populations), making the 

data less comprehensive. We stated that 

the policy on reporting ’’zeros’’ in the 

numerator and/or denominator of a 

CQM, as discussed previously under 

Option 1a, would also apply for Option 

1b. 

• Option 2: Submit and satisfactorily 

report CQMs under the PQRS’s EHR 

Reporting Option. 

We proposed that Medicare EPs who 

participate in both the PQRS EHR 

reporting option and the EHR Incentive 

Program may choose Option 2 instead of 

Option 1. In order to streamline quality 

reporting options for EPs participating 

in both programs, we proposed that 

Medicare EPs who submit and 

satisfactorily report PQRS CQMs under 

the PQRS’s EHR reporting option using 

CEHRT would satisfy the CQM 

reporting requirement under the 

Medicare EHR Incentive Program. We 

referred readers to 42 CFR 414.90 and 

the CY 2012 Medicare PFS final rule 

with comment period (76 FR 73314) for 

more information about the existing 

requirements of the PQRS and stated 

that EPs who choose this Option 2 

would be required to comply with any 

changes to the requirements of the 

PQRS that may apply in future years. 

Comment: Many commenters 

preferred Option 1a instead of 1b since 

it offers more flexibility and a larger 

selection of CQMs, especially for 

specialties including surgery, 

otolaryngology, urology, and psychiatry. 

However, they also indicated that it 

would be difficult to report 1 CQM from 

each of the 6 domains that apply to their 

scope of practice and/or unique patient 

population. 

mstockstill on DSK4VPTVN1PROD with RULES2

54058 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

Other commenters supported Option 

1b over 1a as long as it limits the 

number of CQMs to those that vendors 

would be required to support. A few 

commenters suggested removing the 

‘‘one menu CQM’’ requirement entirely. 

Many commenters suggested a 

modification of Options 1a and 1b to 

require reporting a specific number of 

core CQMs (fewer than the 11 proposed) 

and a specific number of menu CQMs 

(more than 1 as proposed) along with 

some changes to the domain 

requirement. Many commenters 

suggested a reporting option requiring 

EPs to report 6 clinically relevant CQMs 

covering at least 2 domains, and if no 

CQMs are clinically relevant for an EP, 

they must demonstrate zeros in the 

denominator for 6 CQMs covering at 

least 2 domains. A few commenters 

suggested requiring up to 9 CQMs 

covering a range of 2 to 4 domains. One 

commenter also advocated for the 

retention of all three reporting options 

(1a, 1b, and 2) so that EPs could select 

the one most appropriate to their 

practice. 

Response: We agree that a modified 

approach for Option 1 would provide a 

more optimal reporting schema for most 

EPs. In our modified approach, we 

included the positive and minimized 

the negative components of each of the 

two proposed options where possible. 

The Option 1 that we are finalizing (as 

explained in detail later) decreases the 

number of CQMs that EPs must select to 

report, decreases the total number of 

domains required to be covered among 

the selected CQMs, recommends but 

does not require reporting from a ‘‘core’’ 

set of CQMs, and offers specialist EPs 

the flexibility to select CQMs that are 

applicable to their scope of practice. 

We note the following CQMs in the 

finalized recommended core sets for 

adults and children were included in 

the proposed core set: NQF 0018, 0022, 

0024, 0028, 0418, and TBD—Closing the 

referral loop: receipt of specialist report. 

Comment: We also received many 

comments on Option 2. Numerous 

commenters supported Option 2, 

including the submission of CQM data 

via the PQRS program and receiving 

credit for both PQRS and meaningful 

use. However, some of these 

commenters indicated that not all EPs 

qualify to participate in PQRS. Another 

concern was that the patient population 

reported differs between the two 

programs in that PQRS requires 

reporting on Medicare patients only, 

whereas meaningful use reflects all 

patients without regard to payer. 

Response: For the reporting of CQMs, 

we are finalizing Option 2 as proposed 

in order to reduce reporting burden on 

EPs who participate in both programs 

and attain the goal of alignment with the 

PQRS EHR reporting option. EPs who 

do not participate in PQRS may submit 

CQMs for the EHR Incentive Program 

using Option 1. Regardless of whether 

an EP chooses Option 1 or Option 2 for 

CQM reporting, we note that all EPs 

must also report the meaningful use 

objectives and measures through 

attestation, as well as meet all other 

meaningful use requirements. 

We acknowledge that under the 

PQRS, only Medicare patient 

information is submitted. In general, our 

preference is to measure quality at the 

all patient level, based on samples of all 

patient data (that is, patients that meet 

the denominator criteria of each 

reported CQM). We believe this 

provides a better assessment of overall 

care quality rendered by EPs. However, 

although meaningful use reflects all 

patients without regard to payer, we 

believe Option 2 is appropriate because 

it is a step in the direction of the longerterm goal of a single, aligned 

mechanism for multiple CMS programs. 

After consideration of the public 

comments received, and for the reasons 

discussed earlier, we are finalizing two 

reporting options beginning with CY 

2014 for EPs in all stages of meaningful 

use. These options will continue to 

apply in the event that we have not 

engaged in another round of rulemaking 

by CY 2016. 

Option 1: Report 9 CQMs covering at 

least 3 domains. 

Medicare and Medicaid EPs selecting 

this reporting option will be required to 

submit a total of 9 CQMs covering at 

least 3 domains from Table 7. We expect 

EPs would select the CQMs that best 

apply to their scope of practice and/or 

unique patient population. For this 

reporting option, CQMs will be 

submitted on an aggregate basis 

reflective of all patients without regard 

to payer. We are not requiring the 

submission of a core set of CQMs, but 

we identify two recommended core sets, 

one for adults and one for children, that 

we encourage EPs to report to the extent 

those CQMs are applicable to an EP’s 

scope of practice and patient 

population. If an EP’s CEHRT does not 

contain patient data for at least 9 CQMs 

covering at least 3 domains, then the EP 

must report the CQMs for which there 

is patient data and report the remaining 

required CQMs as ‘‘zero denominators’’ 

as displayed by the EP’s CEHRT. If there 

are no CQMs applicable to the EP’s 

scope of practice and patient 

population, EPs must still report 9 

CQMs even if zero is the result in either 

the numerator or the denominator of the 

measure. If all applicable CQMs have a 

value of zero from their CEHRT, then 

EPs must report any 9 CQMs from Table 

7. 

Option 2: Submit and satisfactorily 

report CQMs under the PQRS’s EHR 

Reporting Option. 

Under this option, Medicare EPs who 

participate in both the PQRS and the 

Medicare EHR Incentive Program will 

satisfy the CQM reporting component of 

meaningful use if they submit and 

satisfactorily report PQRS CQMs under 

the PQRS’s EHR reporting option using 

CEHRT. EPs choosing to report under 

this option for purposes of the Medicare 

EHR Incentive Program will be subject 

to the reporting periods established for 

the PQRS EHR reporting option, which 

may be different from their EHR 

reporting period for the meaningful use 

objectives and measures. For example, 

in CY 2014, an EP who is beyond his or 

her first year of meaningful use will 

have a 3-month quarter EHR reporting 

period for the meaningful use objectives 

and measures, but the reporting periods 

for the PQRS EHR reporting option that 

fall within CY 2014 would apply for 

purposes of reporting CQMs. We 

emphasize that EPs who are in their first 

year of demonstrating meaningful use in 

the year immediately preceding a 

payment adjustment year cannot choose 

this Option 2 for reporting CQMs for the 

EHR Incentive Program. For purposes of 

avoiding a payment adjustment, they 

must submit their CQM data by 

attestation no later than October 1 of 

such preceding year. For more 

information on the requirements of the 

PQRS, we refer readers to 42 CFR 414.90 

and the CY 2013 Medicare PFS 

proposed rule (77 FR 44805 through 

44988). EPs who choose this option to 

satisfy the CQM reporting component of 

meaningful use under the Medicare EHR 

Incentive Program will be required to 

comply with any changes to the PQRS 

that may apply in future years. 

(ii) CQMs 

We proposed to remove three CQMs 

beginning with CY 2014 for EPs at all 

stages of meaningful use for the 

following reasons: 

• NQF # 0013—The measure steward 

did not submit this CQM to the NQF for 

continued endorsement. We included 

other CQMs that address high blood 

pressure and hypertension in Table 8 in 

the proposed rule. 

• NQF #0027—We determined this 

CQM is very similar to NQF #0028 a and 

b; therefore, to avoid duplication, we 

proposed to only retain NQF # 0028 a 

and b. 

• NQF #0084—The measure steward 

did not submit this CQM to the NQF for 

continued endorsement. Additionally, 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54059 

CMS has decided to remove this CQM 

because there are other FDA-approved 

anticoagulant therapies available in 

addition to Warfarin. We proposed to 

replace this measure, pending 

availability of electronic specifications, 

with NQF #1525—Atrial Fibrillation 

and Atrial Flutter: Chronic 

Anticoagulation Therapy. 

We did not receive public comments 

and are finalizing the elimination of 

measures NQF #0013, NQF #0027, and 

NQF #0084 beginning with CY 2014 for 

EPs at all stages of meaningful use. We 

proposed to replace NQF #0084 with 

NQF #1525, which was determined to 

contain data elements that were difficult 

to capture in EHRs after additional 

feasibility testing. Therefore, we are 

implementing an Adverse Drug Events 

CQM to replace NQF #0084: 

Title: ADE Prevention and 

Monitoring: Warfarin Time in 

Therapeutic Range. 

Description: Average percentage of 

time in which individuals with atrial 

fibrillation who are on chronic 

anticoagulation have International 

Normalized Ratio (INR) test results 

within the therapeutic range during the 

measurement period. 

For a list of all the CQMs proposed for 

EPs to report for the EHR Incentive 

Programs beginning with CY 2014, 

please refer to Table 8 in the Stage 2 

proposed rule (77 FR 13749 to 13757). 

We stated that we expected to finalize 

only a subset of the CQMs listed in 

Table 8 based on public comments and 

the priorities discussed in section II.B.3. 

of the proposed rule. 

We noted that some of these CQMs 

had not yet been submitted for 

consensus endorsement consideration 

or were under review for endorsement 

consideration by the NQF. We stated 

that we expect that any measure 

proposed in Table 8 for inclusion 

beginning with CY 2014 would be 

submitted for endorsement 

consideration by the measure steward. 

Because measure specifications may 

need to be updated more frequently 

than our expected rulemaking cycle will 

allow for, we stated that we would 

provide updates to the specifications at 

least 6 months prior to the beginning of 

the calendar year for which the 

measures would be required, and we 

expected to update specifications 

annually. 

Comment: Many commenters 

indicated support for CMS’s efforts to 

include CQMs that are broadly 

applicable across primary care and 

specialist EPs. However, many 

commenters also stated that most of the 

proposed CQMs apply to primary care 

practices and preventive medicine and 

requested more CQMs that apply to 

specialist practices or to adjust the 

reporting requirements to match the 

number of clinically available CQMs for 

nonprimary care EPs. Another 

commenter requested pediatricians be 

excluded from having to report on 

CQMs for patients older than 18 years 

old rather than having to demonstrate 

zero denominators on a population that 

does not apply to them. 

Many commenters stated that there 

were too many CQMs, citing issues with 

implementation of such a large set of 

measures as well as diluting the impact 

of quality measurement. Some of these 

commenters believed that CMS should 

focus on a smaller set of CQMs to refine 

for accuracy in implementation. They 

also did not believe that they should 

have to build CQMs into their CEHRT 

if those CQMs did not apply to their 

scope of practice because those CQMs 

would only yield zero denominators. 

Some suggested alternatives to building 

out all CQMs included allowing EPs to 

attest to having a low denominator, such 

as 25 or fewer patients, or for CMS to 

assign the primary care or specialty 

fields that each CQM applies to, 

whereby EPs whose field is not listed 

for a particular CQM would be exempt 

from reporting that CQM. 

Many of the proposed EP CQMs 

received support from the public. Some 

commenters gave feedback on specific 

proposed CQMs, including questions on 

the feasibility of reporting the CQM, 

issues with specific requirements of the 

CQM, and preferences for preventative 

CQMs. A few commenters did not 

support finalizing CQMs that were not 

NQF endorsed. We also received 

suggestions for additional CQMs that 

were not included in the list of 125 

proposed EP CQMs. A few commenters 

expressed concern about the lack of 

transparency in the development of the 

CQMs. 

Response: We stated in the Stage 2 

proposed rule that we would be 

finalizing a subset of the proposed 

CQMs. We convened a Quality 

Measures Task Force (QMTF), which is 

made up of stakeholders from across the 

Department and includes representation 

from different quality reporting 

programs. Through the QMTF and with 

senior leadership, we considered public 

comments, feasibility of the electronic 

specifications to be captured in EHRs, 

and the goals stated in section II.B.3. of 

this final rule when selecting the 

finalized list of EP CQMs. By including 

such a large representation of 

stakeholders, we believe that we have 

prioritized CQMs that align with other 

programs, which includes CQMs that 

are not used in other programs currently 

but could be implemented in other 

programs as they include more 

electronically specified CQMs in their 

respective CQM lists. This will move us 

closer to our longer-term goal of having 

a single, aligned mechanism for CQM 

reporting. 

Since the measure stewards are 

responsible for any information that 

affects the requirements of the CQM, we 

have shared the feedback on specific 

CQMs with the respective measure 

stewards. Consideration of both 

evidence and expert consensus are 

integral parts of the NQF’s measure 

endorsement process. More information 

on this Consensus Development Process 

is available on the NQF Web site: 

http://www.qualityforum.org/

Measuring_Performance/Consensus_

Development_Process.aspx. Although 

we give preference to CQMs that have 

been endorsed by NQF, section 

1848(o)(2)(B)(i)(I) of the Act does not 

require the selection of NQF-endorsed 

CQMs for the EHR Incentive Program. 

Please refer to section II.B.3. of this final 

rule for the discussion on criteria for 

inclusion of a CQM. 

We appreciate the commenters’ 

suggestions for additional CQMs that 

apply to specialties that may not have 

been as represented in the measure set 

as primary care or preventative 

medicine. Although we cannot in this 

final rule select CQMs that were not 

proposed in the proposed rule, we will 

consider the suggested CQMs for future 

inclusion. As for the commenters’ 

request to adjust the reporting 

requirements or exclude certain 

specialties from reporting certain CQMs, 

we believe that our policy on allowing 

‘‘zero denominators’’ to be reported 

allows specialists to meet the CQM 

reporting requirements of meaningful 

use and is a continuation of our policy 

from the Stage 1 final rule. 

Comment/Response: Table 7 

summarizes the public comments 

received on specific proposed EP CQMs 

and the CMS rationale (that is, our 

response to the CQM-specific 

comment(s)) for finalizing or not 

finalizing the CQM for reporting 

beginning with CY 2014. 

mstockstill on DSK4VPTVN1PROD with RULES2

54060 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 7—SUMMARY OF EP CQM-SPECIFIC COMMENTS AND RATIONALE TO FINALIZE OR NOT FINALIZE THE CQM 

CQM No. Commenters support 

finalization 

Commenters do not support 

finalization Finalized Rationale 

NQF 0002 ................................. No comments .......................... No comments .......................... Yes .......... Addresses efficient use of resources; alignment with 

other programs. 

NQF 0004 ................................. Supports measure ................... Privacy concerns; concerned 

that it could be difficult to 

implement.

Yes .......... Addresses high priority agency 

goals and aligns with other 

quality reporting programs. 

We retained NQF 0004 in 

order to represent the important issue of alcohol or 

other drug dependence 

treatment in our measure 

set. We also believe that 

through our collaboration 

with ONC, we have addressed the issues associated with data collection. 

NQF 0018 ................................. Public comment supports 

measure.

No comments .......................... Yes .......... Supports high priority goals 

(controlling high blood pressure). 

NQF 0022 ................................. No comments .......................... Measure is not supported by 

evidence.

Yes .......... Addresses patient safety. NQF 

requires clinical evidence 

supporting a measure in 

order to achieve NQF endorsement. 

NQF 0024 ................................. Support for measure but evidence only for overweight, 

obese, or underweight children and not ideal weight.

Contains data elements that 

are difficult to capture as 

structured data.

Yes .......... Supports high priority goals 

(weight assessment, nutrition, physical activity for children); received strong public 

support. Based on industry 

standards, CMS is collaborating with other federal 

agencies and private organizations to standardize data 

elements. 

NQF 0028 ................................. Support for measure ............... Concerns about capturing discrete data.Yes .......... Supports high priority goals 

(tobacco use cessation); 

alignment with other programs. 

NQF 0031 ................................. No comments .......................... Does not align with current 

clinical guidelines for frequency of screening.

Yes .......... This CQM is currently NQF 

endorsed.# This is a high 

priority prevention measure 

for breast cancer. 

NQF 0032 ................................. No comments .......................... Does not align with current 

clinical guidelines for frequency of screening.

Yes .......... This CQM is currently NQF 

endorsed# and will be updated for consistency with 

clinical guidelines as discussed earlier in this section. This is a high priority 

prevention measure for cervical cancer. 

NQF 0033 ................................. No comments .......................... Does not align with current 

clinical guidelines for frequency of screening.

Yes .......... This CQM is currently NQF 

endorsed# and will be updated for consistency with 

clinical guidelines as discussed earlier in this section. This is a high priority 

prevention measure. 

NQF 0034 ................................. No comments .......................... Does not align with current 

clinical guidelines.

Yes .......... This CQM is currently NQF 

endorsed# and will be updated for consistency with 

clinical guidelines as discussed earlier in this section. This is a high priority 

prevention measure. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54061 

TABLE 7—SUMMARY OF EP CQM-SPECIFIC COMMENTS AND RATIONALE TO FINALIZE OR NOT FINALIZE THE CQM— 

Continued 

CQM No. Commenters support 

finalization 

Commenters do not support 

finalization Finalized Rationale 

NQF 0036 ................................. No comments .......................... Duplicative of other measures 

(duplicate measure not included).

Yes .......... Addresses high priority agency 

goals and aligns with other 

quality reporting programs. 

Some aspects of this measure may be considered duplicative of other CQMs, 

however we believe that 

there are unique aspects of 

this CQM that are important 

to measure. 

NQF 0038 ................................. Supports measures to reduce 

rate of Hepatitis B.

No comments .......................... Yes .......... Supports public health goals. 

NQF 0041 ................................. Support for measure ............... No evidence to support influenza vaccinations for all patients; Concerns about capturing discrete data and accounting for alternative delivery locations.Yes .......... This CQM is currently NQF 

endorsed.# This is a high 

priority prevention measure. 

Delivery of the vaccine 

should be captured in the 

EHR even if it was delivered 

in an alternate location. 

NQF 0043 ................................. Support for measure ............... Concerns about capturing discrete data and accounting 

for alternative delivery locations.

Yes .......... Alignment with PQRS/ACOs/ 

NCQA–PCMH Accreditation. 

This is a high priority prevention measure. Delivery of 

the vaccine should be captured in the EHR even if it 

was delivered in an alternate location. Passed feasibility testing for the data elements needed. 

NQF 0052 ................................. Support with suggestions for 

improvements.

No comments .......................... Yes .......... Addresses efficient use of resources. 

NQF 0055 ................................. No comments .......................... Inconsistent with evidence ...... Yes .......... This CQM is currently NQF 

endorsed.# This is a high 

priority prevention measure. 

NQF 0056 ................................. Support for measure ............... Concerns about ability to collect discrete data.Yes .......... Supports high priority goals 

(diabetes); alignment with 

other programs. Passed feasibility testing for the data 

elements needed. 

NQF 0059 ................................. Support for measure ............... No comments .......................... Yes .......... Supports high priority goals 

(diabetes); alignment with 

other programs. 

NQF 0060 ................................. Support for measure ............... Concern that this measure is 

untested in a pediatric population.

Yes .......... Supports high priority goals 

(diabetes, pediatric population). 

NQF 0062 ................................. Supports measure ................... No comments .......................... Yes .......... Supports high priority goals 

(diabetes); alignment with 

other programs. 

NQF 0064 ................................. Supports measure as a way to 

monitor overuse and 

non-evidence based therapies.

No comments .......................... Yes .......... Supports high priority goals 

(diabetes); alignment with 

other programs. 

NQF 0068 ................................. Support for measure ............... No comments .......................... Yes .......... Supports high priority goals 

(heart disease); alignment 

with other programs. 

NQF 0069 ................................. No comments .......................... No comments .......................... Yes .......... Addresses efficient use of resources; alignment with 

other programs. 

NQF 0070 ................................. Support for measure ............... No comments .......................... Yes .......... Supports high priority goals 

(heart disease); alignment 

with other programs. 

NQF 0075 ................................. Support for measure ............... Denominator is complex and 

ability to capture prior year 

data is questioned.

Yes .......... Supports high priority goals 

(heart disease); alignment 

with other programs. We are 

also collaborating very 

closely with the ONC to ensure that these data are 

captured within CEHRT. 

mstockstill on DSK4VPTVN1PROD with RULES2

54062 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 7—SUMMARY OF EP CQM-SPECIFIC COMMENTS AND RATIONALE TO FINALIZE OR NOT FINALIZE THE CQM— 

Continued 

CQM No. Commenters support 

finalization 

Commenters do not support 

finalization Finalized Rationale 

NQF 0081 ................................. Support for measure ............... No comments .......................... Yes .......... Supports high priority goals 

(heart disease); alignment 

with other programs. 

NQF 0083 ................................. Support for measure ............... No comments .......................... Yes .......... Supports high priority goals 

(heart disease); alignment 

with other programs. 

NQF 0086 ................................. Support for measure ............... Does not advance quality of 

care.

Yes .......... This CQM is currently NQF 

endorsed.#

NQF 0088 ................................. Supports measure ................... Concerned about ability to 

transmit data between providers.

Yes .......... Supports high priority goals 

(diabetes); alignment with 

other programs. Data is not 

required to be electronically 

transmitted between providers. 

NQF 0089 ................................. Supports measure ................... Does not advance quality of 

care; Concerned about ability to transmit data between 

providers.

Yes .......... This CQM is currently NQF 

endorsed.# Communication 

between eye specialist and 

the physician who manages 

diabetes care is important. 

Data is not required to be 

electronically transmitted between providers. 

NQF 0101 ................................. Support for measure ............... Concerns about ability to collect discrete data.Yes .......... Addresses patient safety. 

Passed feasibility testing for 

the data elements required. 

NQF 0104 ................................. Support for measure ............... Duplicative of other measures; 

Concerns about ability to 

collect discrete data.

Yes .......... Supports public health goals; 

alignment with other programs. Duplicative measures have not been finalized. Takes initial steps toward collecting discrete 

data. 

NQF 0105 ................................. Support for measure ............... Concerns about suggesting 

pharmacotherapy over other 

treatment options.

Yes .......... This CQM is currently NQF 

endorsed.#

NQF 0108 ................................. No comments .......................... No comments .......................... Yes .......... Addresses pediatric population. 

NQF 0110 ................................. Support for measure ............... Concerns about complexity 

and confidentiality; Concerns about ability to collect 

discrete data.

Yes .......... We are collaborating very 

closely with the ONC to ensure that these data are 

captured within CEHRT. 

NQF 0384 ................................. Support for measure ............... Concerns about ability to collect discrete data.Yes .......... Addresses patient engagement; alignment with other 

programs. 

NQF 0385 ................................. Supports measure ................... Concerns about ability to collect discrete data.Yes .......... Addresses high priority agency 

goals and aligns with other 

quality reporting programs. 

NQF 0387 ................................. Support for measure ............... Concerns about ability to collect discrete data.Yes .......... Addresses high priority agency 

goals and aligns with other 

quality reporting programs. 

NQF 0389 ................................. Support for measure ............... Concerns about complexity; 

Concerns about ability to 

collect discrete data.

Yes .......... We are collaborating very 

closely with the ONC to ensure that these data are 

captured within CEHRT. 

NQF 0403 ................................. Support for measure ............... Concerns about ability to document AIDS status.Yes .......... Addresses high priority agency 

goals and aligns with other 

quality reporting programs. 

NQF 0405 ................................. Support for measure ............... Concerns about agreement 

with current clinical guidelines.

Yes .......... This CQM is currently NQF 

endorsed# and will be updated for consistency with 

clinical guidelines as discussed earlier in this section. 

TBD (proposed as NQF 

0407—HIV/AIDS RNA Control).

Support for measure ............... Concerns about ability to collect discrete data.Yes .......... Alignment with other programs. This CQM will be updated for consistency with 

the clinical guidelines as discussed earlier in this section. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54063 

TABLE 7—SUMMARY OF EP CQM-SPECIFIC COMMENTS AND RATIONALE TO FINALIZE OR NOT FINALIZE THE CQM— 

Continued 

CQM No. Commenters support 

finalization 

Commenters do not support 

finalization Finalized Rationale 

NQF 0418 ................................. Support for assessment of depression.Concern that patient refusal of 

screening could count 

against EP; Concerns about 

ability to collect discrete 

data.

Yes .......... Supports public health goals; 

alignment with other programs. 

We also recognize that patients may refuse the treatments measured within this 

CQM, but there are no performance thresholds established for the EHR Incentive 

Program. 

NQF 0419 ................................. Support for measure with concerns about ability to capture discrete data.Too check-boxy and does not 

advance quality of care.

Yes .......... This CQM is currently NQF 

endorsed.#

NQF 0421 ................................. Support for measure ............... Too check-boxy and does not 

advance quality of care; 

Concerns about ability to 

collect discrete data.

Yes .......... Supports public health goals. 

Alignment with PQRS/ 

ACOs/UDS. This CQM is 

currently NQF endorsed.#

Passed feasibility testing for 

the data elements needed. 

NQF 0564 ................................. Supports measure that targets 

high priority condition to 

Medicare population and will 

add substantial value to the 

clinical quality measure set.

No comments .......................... Yes .......... Addresses patient safety; 

alignment with other programs. 

NQF 0565 ................................. Supports measure that targets 

high priority condition to 

Medicare population and will 

add substantial value to the 

clinical quality measure set.

No comments .......................... Yes .......... Alignment with other programs. 

NQF 0608 ................................. No comments .......................... No comments .......................... Yes .......... Addresses high priority agency 

goals. 

NQF 0710 ................................. Supports measure concept but 

concerned metric is too high.

Privacy concerns ..................... Yes .......... Addresses high priority agency 

goals. 

To protect patient confidentiality and adhere to HIPAA 

requirements, CMS and all 

contractors for CMS are 

held to maintaining and 

abiding by the IT Security 

Policy in the transmission of 

electronic data. 

NQF 0712 ................................. Supports measure ................... Privacy concerns; Concerns 

about ability to collect discrete data.

Yes .......... Addresses high priority agency 

goals and takes initial steps 

towards collecting accurate 

discrete data. To protect patient confidentiality and adhere to HIPAA requirements, CMS and all contractors for CMS are held to 

maintaining and abiding by 

the IT Security Policy in the 

transmission of electronic 

data. 

TBD (proposed as 1335 Children dental).Supports measure ................... Concerns about collecting data 

via EHR and required 

changes to workflow; Concerns about ability to collect 

discrete data.

Yes .......... Addresses child health and 

dental measures not previously included in program. 

We are collaborating very 

closely with the ONC to ensure that these data are 

captured within CEHRT. 

NQF 1365 ................................. Support for measure ............... Concerns about ability to collect discrete data.Yes .......... Supports public health goals; 

alignment with other programs. Duplicative measures have not been finalized. Takes initial steps toward collecting discrete 

data. 

mstockstill on DSK4VPTVN1PROD with RULES2

54064 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 7—SUMMARY OF EP CQM-SPECIFIC COMMENTS AND RATIONALE TO FINALIZE OR NOT FINALIZE THE CQM— 

Continued 

CQM No. Commenters support 

finalization 

Commenters do not support 

finalization Finalized Rationale 

NQF 1401 ................................. No comments .......................... Concerns about linking measure to age of child when 

measure relates to maternal 

depression and ability to 

capture discrete data.

Yes .......... Addresses public health goals. 

We are collaborating very 

closely with the ONC to ensure that these data are 

captured within CEHRT. 

TBD (proposed as 1419 Primary caries prevention).Support if revised to clarify numerator and denominator.Concerns about whether 

measure reflects standard of 

care for medical providers.

Yes .......... Addresses child health and 

dental measures not previously included in program. 

Received strong public support. The CQM is currently 

NQF endorsed for medical 

providers.#

TBD (LDL) ................................ Supports measure ................... Not NQF endorsed; Concerns 

about ability to collect discrete data.

Yes .......... Addresses high priority goal 

(high cholesterol); Though 

we gave preference to NQF 

endorsement, some measures selected that were not 

NQF endorsed based on 

their measurement of high 

priority conditions. 

TBD (Fasting LDL) ................... Supports measure ................... Not NQF endorsed; Concerns 

about ability to collect discrete data.

Yes .......... Addresses high priority goal 

(high cholesterol); Though 

we gave preference to NQF 

endorsement, some measures selected that were not 

NQF endorsed based on 

their measurement of high 

priority conditions. 

TBD (Dementia) ....................... Supports measure ................... Not NQF endorsed; Concerns 

about ability to collect discrete data.

Yes .......... Addresses high priority agency 

goals and takes initial steps 

towards collecting accurate 

discrete data; Though we 

gave preference to NQF endorsement, some measures 

selected that were not NQF 

endorsed based on their 

measurement of high priority 

conditions. 

TBD (Hypertension) ................. No comments .......................... No comments .......................... Yes .......... Addresses high priority goal 

(hypertension). 

TBD (Closing referral loop) ...... Supports as an example of a 

core measure.

Concerns about ability to capture data exchange; not 

NQF endorsed.

Yes .......... Addresses care coordination; 

Though we gave preference 

to NQF endorsement, some 

measures selected that 

were not NQF endorsed 

based on their measurement 

of high priority conditions. 

TBD (FSA knee) ....................... Supports measure ................... Not NQF endorsed; Concerns 

about ability to collect discrete data.

Yes .......... Addresses functional status 

assessment and patient engagement; Though we gave 

preference to NQF endorsement, some measures selected that were not NQF 

endorsed based on their 

measurement of high priority 

conditions. 

TBD (FSA hip) .......................... Supports measure ................... Not NQF endorsed; Concerns 

about ability to collect discrete data.

Yes .......... Addresses functional status 

assessment and patient engagement; Though we gave 

preference to NQF endorsement, some measures selected that were not NQF 

endorsed based on their 

measurement of high priority 

conditions. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54065 

TABLE 7—SUMMARY OF EP CQM-SPECIFIC COMMENTS AND RATIONALE TO FINALIZE OR NOT FINALIZE THE CQM— 

Continued 

CQM No. Commenters support 

finalization 

Commenters do not support 

finalization Finalized Rationale 

TBD (FSA complex) ................. Supports measure ................... Not NQF endorsed; Concerns 

about ability to collect discrete data.

Yes .......... Addresses functional status 

assessment and patient engagement; Though we gave 

preference to NQF endorsement, some measures selected that were not NQF 

endorsed based on their 

measurement of high priority 

conditions. 

TBD (ADE) ............................... Supports .................................. Not NQF endorsed; Concerns 

about ability to collect discrete data.

Yes .......... Addresses patient safety; 

Though we gave preference 

to NQF endorsement, some 

measures selected that 

were not NQF endorsed 

based on their measurement 

of high priority conditions. 

TBD (HBP followup) ................. No comments .......................... Measure focuses on limited 

population; not NQF endorsed.

Yes .......... Addresses high priority goals 

(hypertension); Though we 

gave preference to NQF endorsement, some measures 

selected that were not NQF 

endorsed based on their 

measurement of high priority 

conditions. 

NQF 0001 ................................. Supports measure ................... Does not advance quality of 

care; Concerns about ability 

to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0012 ................................. Measure could be adapted to 

use EHRs to create more 

accurate quality measures.

No comments .......................... No ............ Measure no longer supported 

by measure steward. 

NQF 0014 ................................. No comments .......................... Does not advance quality of 

care.

No ............ Measure no longer supported 

by measure steward. 

NQF 0045 ................................. No comments .......................... Measure is untested in part of 

population age range; focus 

on communications instead 

of outcomes.

No ............ Difficulty ensuring accurate 

and standard data collected. 

NQF 0046 ................................. Supports measure ................... Concerns about ability to collect discrete data.No ............ Difficulty ensuring accurate 

and standard data collected. 

NQF 0047 ................................. Supports measure ................... Measure is complicated; concern about lack of look back 

period.

No ............ Difficulty ensuring accurate 

and standard data collected. 

NQF 0048 ................................. Supports measure with suggested changes.No comments .......................... No ............ Difficulty ensuring accurate 

and standard data collected. 

NQF 0050 ................................. Supports measure ................... Does not advance quality of 

care; Concerns about ability 

to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0051 ................................. Supports measure ................... Concerns about ability to collect discrete data.No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0058 ................................. No comments .......................... Definition of condition too restrictive.No ............ Concur with public comment 

that acute bronchitis is too 

restrictive for an antibiotic 

overuse CQM. Seek to limit 

measure set to reduce burden. 

NQF 0061 ................................. Support for measure ............... No comments .......................... No ............ Redundant with other measures assessing condition 

(e.g., NQF 0018). 

NQF 0066 ................................. Support for measure ............... Measure contains two diagnoses and should separated 

into two measures; Concerns about ability to collect 

discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0067 ................................. Support for measure ............... Concerns about ability to collect discrete data.No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0073 ................................. Support for measure and suggestion to adapt to further 

exploit EHRs.

No comments .......................... No ............ Redundant with other measures assessing condition 

(e.g., NQF 0018). 

mstockstill on DSK4VPTVN1PROD with RULES2

54066 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 7—SUMMARY OF EP CQM-SPECIFIC COMMENTS AND RATIONALE TO FINALIZE OR NOT FINALIZE THE CQM— 

Continued 

CQM No. Commenters support 

finalization 

Commenters do not support 

finalization Finalized Rationale 

NQF 0074 ................................. Support for measure ............... Concerns about ability to collect discrete data.No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0097 ................................. Support for measure ............... Measure does not advance 

quality of care, too ‘‘check 

boxy,’’ reconciling across 

care settings; Concerns 

about ability to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0098 ................................. Support for measure ............... Measure is vague; ability to 

capture discrete data; need 

standardized tool for assessment; no evidence 

interventions support outcomes.

No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0100 ................................. Support for measure ............... No evidence interventions support outcomes; Concerns 

about ability to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0102 ................................. Support for measure ............... Concerns about ability to collect discrete data and calculate measure.No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0103 ................................. Support for measure; harmonize with other measures.Does not advance quality of 

care; privacy issues; Concerns about ability to collect 

discrete data.

No ............ Concur with concerns in public 

comments. 

NQF 0106 ................................. Support for measure ............... Measure is too complex; concerns about ability to collect 

discrete data.

No ............ Concur with concerns in public 

comments that the measure 

is too complex; and agree 

with the concerns about 

ability to collect discrete 

data. 

NQF 0107 ................................. No comments .......................... Duplicative of other measures No ............ Concur with concerns in public 

comments that it is duplicative of other measures. 

NQF 0112 ................................. Support for measure ............... Measure is too complex; privacy issues; vague; concerns about ability to collect 

discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0239 ................................. Support for measure ............... Concerns about ability to collect discrete data.No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

Former NQF 0246 .................... Support for measure ............... Does not advance quality of 

care; not NQF endorsed; 

Concerns about ability to 

collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0271 ................................. Support for measure ............... Questions if appropriate for 

ambulatory setting; Concerns about ability to collect 

discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0312 ................................. Support for measure ............... Measure is vague .................... No ............ Difficulty ensuring accurate 

and standard data collected. 

NQF 0321 ................................. Support for measure ............... No comments .......................... No ............ Complexity associated with 

collecting discrete data. 

NQF 0322 ................................. Support for measure ............... Measure is vague; concerns 

about ability to capture discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0323 ................................. Support for measure ............... Interoperability concerns ......... No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0382 ................................. Support for measure ............... Concerns about ability to capture numerator data.No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0383 ................................. Support for measure ............... Concerns about ability to collect discrete data.No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0388 ................................. Support for measure ............... Concerns about ability to collect discrete data.No ............ Measure retired by steward. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54067 

TABLE 7—SUMMARY OF EP CQM-SPECIFIC COMMENTS AND RATIONALE TO FINALIZE OR NOT FINALIZE THE CQM— 

Continued 

CQM No. Commenters support 

finalization 

Commenters do not support 

finalization Finalized Rationale 

NQF 0399 ................................. Support for measure ............... No comments .......................... No ............ Seek to limit measure set to 

reduce burden. 

NQF 0400 ................................. Support for measure ............... No comments .......................... No ............ Seek to limit measure set to 

reduce burden. 

NQF 0401 ................................. Support for measure ............... Concerns about ability to collect discrete data.No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0406 ................................. Support for measure ............... Concerns about keeping 

up-to-date with changing 

guidelines.

No ............ Concur with concerns from 

public comments with concerns about keeping 

up-to-date with changing 

guidelines. 

NQF 0507 ................................. Support for measure ............... Does not advance quality of 

care.

No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0508 ................................. Support for measure ............... Inability to capture screening 

results as discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0510 ................................. Support for measure ............... Concerns about ability to collect discrete data.No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0513 ................................. Support for measure ............... Concerns about ability to collect discrete data.No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0519 ................................. Support for measure ............... Does not advance quality of 

care; Concerns about ability 

to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0561 ................................. Support for measure; supports 

care coordination and alignment with PQRS.

Does not advance quality of 

care; Concerns about ability 

to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0562 ................................. Support for measure ............... Concerns about ability to collect discrete data; important 

measure of overuse.

No ............ Concur with public comment 

and complexity associated 

with collecting discrete data. 

NQF 0575 ................................. Support for measure with reasonable target regarding potential adverse effects of 

tight diabetes control.

No comments .......................... No ............ Concur with concerns in public 

comments regarding potential adverse effects of tight 

diabetes control. 

NQF 0711 ................................. Supports measure concept but 

concerned metric is too high.

Potentially duplicative; privacy 

issues.

No ............ Concur with concerns in public 

comments about potentially 

duplicative measure; and 

privacy issues. 

NQF 1525 ................................. Support for measure ............... Concerns about ability to collect discrete data.No ............ Concur with public comment 

and complexity associated 

with collecting these discrete 

data. 

TBD (Risk Assessment for 

Falls).

Support for measure ............... Not NQF endorsed. Concerns 

about ability to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting these discrete 

data. 

TBD (Plan of Care for Falls) .... Support for measure ............... Not NQF endorsed; questions 

evidence base for plan of 

care for falls.

No ............ Concur with public comment 

and complexity associated 

with collecting these discrete 

data. 

TBD (ADK: BP Mgmt) .............. Support for measure ............... Not NQF endorsed. Concerns 

about ability to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting these discrete 

data. 

TBD (ADK: ESA) ...................... Support for measure ............... Not NQF endorsed. Concerns 

about ability to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting these discrete 

data. 

TBD (Wound Wet to Dry) ......... Support for measure ............... Not NQF endorsed. Concerns 

about ability to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting these discrete 

data. 

TBD (Dementia Staging) .......... Support for measure ............... Not NQF endorsed; does not 

advance quality of care. 

Concerns about ability to 

collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting these discrete 

data. 

mstockstill on DSK4VPTVN1PROD with RULES2

54068 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 7—SUMMARY OF EP CQM-SPECIFIC COMMENTS AND RATIONALE TO FINALIZE OR NOT FINALIZE THE CQM— 

Continued 

CQM No. Commenters support 

finalization 

Commenters do not support 

finalization Finalized Rationale 

TBD (Dementia FSA) ............... Support for measure ............... Not NQF endorsed. Concerns 

about ability to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting these discrete 

data. 

TBD (Dementia Safety) ............ Support for measure ............... Not NQF endorsed. Concerns 

about ability to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting these discrete 

data. 

TBD (Dementia Driving) ........... Support for measure ............... Not NQF endorsed. Concerns 

about ability to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting these discrete 

data. 

TBD (Dementia Caregiver) ...... Support for measure ............... Not NQF endorsed. Concerns 

about ability to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting these discrete 

data. 

TBD (Wound Compression) ..... Support for measure ............... Not NQF endorsed. Concerns 

about ability to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting these discrete 

data. 

TBD (RA: FSA) ........................ Support for measure ............... Not NQF endorsed. Concerns 

about ability to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting these discrete 

data. 

TBD (Glaucoma) ...................... No comments .......................... Not NQF endorsed .................. No ............ Concur with public comment 

and complexity associated 

with collecting these discrete 

data. 

TBD (Wound Diabetic) ............. Support for measure ............... Not NQF endorsed. Concerns 

about ability to collect discrete data.

No ............ Concur with public comment 

and complexity associated 

with collecting these discrete 

data. 

TBD (Hypertension: BPM) ....... No comments .......................... Not NQF endorsed; questions 

appropriateness due to narrow population.

No ............ Prefer CQMs on the topic of 

hypertension with NQF endorsement. 

# NQF endorsement includes a consensus development process that takes into account clinical guidelines and scientific evidence. NQF describes its consensus development process at http://www.qualityforum.org/Measuring_Performance/Consensus_Development_Process.aspx. 

After consideration of the public 

comments received and the CQM 

selection criteria discussed, we are 

finalizing the list of 64 CQMs for EPs 

included in Table 7. We note that the 

CQMs that do not have a CQM number 

in Table 7 are those that are not NQF 

endorsed. EPs will identify these CQMs 

by the eMeasure ID and version number 

that will be included in the CQM 

specifications that will be made 

available on our Web site. 

We also note that three of the CQMs 

listed with a CQM number of TBD in 

Table 7 were proposed with NQF 

numbers but are changed to ‘‘TBD’’ in 

this final rule as follows: 

• NQF 0407 is now HIV/AIDS: RNA 

control for Patients with HIV 

• NQF 1335 is now Children who have 

dental decay or cavities 

• NQF 1419 is now Primary Caries 

Prevention Intervention as Part of Well/ 

Ill Child Care as Offered by Primary 

Care Medical Providers 

NQF 0407 referenced antiretroviral 

therapy as the means for RNA control. 

This CQM is scheduled for NQF review 

and, due to changing clinical guidelines 

regarding therapies, significant change 

in this measure is expected. Due to the 

nature of HIV/AIDS, the virus mutates 

frequently, necessitating frequent 

changes in clinical guidelines with 

respect to treatments. By respecifying 

the CQM to remove antiretroviral 

therapy as the specific treatment and 

only focus on the outcome of RNA 

control, the intent of this CQM remains 

the same. The respecified CQM will be 

submitted to NQF for endorsement. 

NQF 1335 was endorsed as populationbased CQMs rather than individual 

provider-level CQMs and will be 

respecified to include individual 

provider reporting, and NQF 1419 was 

endorsed at the individual provider 

level but only for primary care 

physicians and will be respecified to 

include dental providers. Both will 

undergo additional testing, and the 

results for each CQM will be submitted 

to NQF to determine whether the 

respecification warrants a new NQF 

number. However, the intent of each of 

these CQMs will remain the same as 

proposed. 

The CQMs finalized in the 

recommended core sets are included in 

Table 7 and are denoted with a ‘‘*’’ for 

adult populations (9 CQMs) and ‘‘**’’ 

for pediatric populations (9 CQMs). We 

believe this approach supports the NQS 

and provides flexibility for specialists 

whose scope of practice may not be 

adequately represented in the proposed 

core CQM set. Controlling blood 

pressure has been and continues to be 

a high priority goal in many national 

health initiatives, including the Million 

Hearts campaign. Therefore, we 

emphasize the importance of reporting 

NQF #0018 as a primary recommended 

core CQM. We will monitor reporting on 

NQF #0018 and consider ways to 

increase its reporting. This may include, 

through future rulemaking, requiring 

EPs in relevant specialties such as 

primary care and cardiovascular care to 

report this CQM. We note that the 

designation of being recommended for 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54069 

the adult population or pediatric 

population does not limit an EP from 

reporting the CQM only for those 

populations as long as the patients still 

fit the criteria to be included in the 

measure (for example, the CQM 

numbered ‘‘TBD—Closing the referral 

loop: receipt of specialist report’’ is 

designated as a recommended core CQM 

for adult populations, but it can apply 

to pediatric populations as well). 

TABLE 8—CQMS FINALIZED FOR MEDICARE AND MEDICAID EPS BEGINNING WITH CY 2014 

CQM No. CQM title and description Measure steward and 

contact information 

Other quality measure 

programs that use the 

same CQM*** 

New CQM Domain 

NQF 0002** ............... Title: Appropriate Testing for Children with Pharyngitis.

Description: Percentage of children 2–18 years of 

age who were diagnosed with pharyngitis, ordered an antibiotic and received a group A streptococcus (strep) test for the episode. 

National Committee 

for Quality Assurance (NCQA) Contact information: 

www.ncqa.org.

EHR PQRS, 

CHIPRA.

......................... Efficient Use of 

Healthcare Resources. 

NQF 0004 .................. Title: Initiation and Engagement of Alcohol and 

Other Drug Dependence Treatment.

Description: Percentage of patients 13 years of 

age and older with a new episode of alcohol and 

other drug (AOD) dependence who received the 

following. Two rates are reported. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS, HEDIS, 

state use, ACA 

2701, NCQA– 

PCMH Recognition.

......................... Clinical Process/Effectiveness. 

a. Percentage of patients who initiated treatment 

within 14 days of the diagnosis. 

b. Percentage of patients who initiated treatment 

and who had two or more additional services 

with an AOD diagnosis within 30 days of the initiation visit. 

NQF 0018* ................. Title: Controlling High Blood Pressure ....................

Description: Percentage of patients 18–85 years of 

age who had a diagnosis of hypertension and 

whose blood pressure was adequately controlled 

(<140/90mmHg) during the measurement 

=period. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS, ACO, 

Group Reporting 

PQRS, UDS.

......................... Clinical Process/Effectiveness. 

NQF 0022* ................. Title: Use of High-Risk Medications in the Elderly ..

Description: Percentage of patients 66 years of 

age and older who were ordered high-risk medications. Two rates are reported. 

NCQA Contact Information: 

www.ncqa.org.

PQRS ....................... New ................. Patient Safety 

a. Percentage of patients who were ordered at 

least one high-risk medication. 

b. Percentage of patients who were ordered at 

least two different high-risk medications. 

NQF 0024** ............... Title: Weight Assessment and Counseling for Nutrition and Physical Activity for Children and Adolescents.NCQA Contact information: 

www.ncqa.org.

EHR PQRS, UDS .... ......................... Population/Public 

Health. 

Description: Percentage of patients 3–17 years 

of age who had an outpatient visit with a 

Primary Care Physician (PCP) or Obstetrician/Gynecologist (OB/GYN) and who had 

evidence of the following during the measurement period. Three rates are reported.

• Percentage of patients with height, weight, 

and body mass index (BMI) percentile documentation.

• Percentage of patients with counseling for 

nutrition.

• Percentage of patients with counseling for 

physical activity.

NQF 0028* ................. Title: Preventive Care and Screening: Tobacco ......

Use: Screening and Cessation Intervention. 

Description: Percentage of patients aged 18 years 

and older who were screened for tobacco use 

one or more times within 24 months AND who 

received cessation counseling intervention if 

identified as a tobacco user. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org.

EHR PQRS, ACO, 

Group Reporting 

PQRS, UDS.

......................... Population/Public 

Health. 

NQF 0031 .................. Title: Breast Cancer Screening ................................

Description: Percentage of women 40–69 years of 

age who had a mammogram to screen for breast 

cancer. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS, ACO, 

Group Reporting 

PQRS, ACA 2701, 

HEDIS, state use, 

NCQA–PCMH 

Recognition.

......................... Clinical Process/Effectiveness. 

NQF 0032 .................. Title: Cervical Cancer Screening .............................

Description: Percentage of women 21–64 years of 

age, who received one or more Pap tests to 

screen for cervical cancer. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS, ACA 

2701, HEDIS, 

state use, NCQA– 

PCMH Recognition, UDS.

......................... Clinical Process/Effectiveness. 

NQF 0033** ............... Title: Chlamydia Screening for Women ...................

Description: Percentage of women 16–24 years of 

age who were identified as sexually active and 

who had at least one test for chlamydia during 

the measurement period. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS, 

CHIPRA, ACA 

2701, HEDIS, 

state use, NCQA– 

PCMH Recognition.

......................... Population/Public 

Health. 

mstockstill on DSK4VPTVN1PROD with RULES2

54070 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 8—CQMS FINALIZED FOR MEDICARE AND MEDICAID EPS BEGINNING WITH CY 2014—Continued 

CQM No. CQM title and description Measure steward and 

contact information 

Other quality measure 

programs that use the 

same CQM*** 

New CQM Domain 

NQF 0034 .................. Title: Colorectal Cancer Screening ..........................

Description: Percentage of adults 50–75 years of 

age who had appropriate screening for colorectal 

cancer. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS, ACO, 

Group Reporting 

PQRS, NCQA– 

PCMH Recognition.

......................... Clinical Process/Effectiveness. 

NQF 0036** ............... Title: Use of Appropriate Medications for Asthma ...

Description: Percentage of patients 5–64 years of 

age who were identified as having persistent 

asthma and were appropriately prescribed medication during the measurement period. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS .............. ......................... Clinical Process/Effectiveness. 

NQF 0038** ............... Title: Childhood Immunization Status ......................

Description: Percentage of children 2 years of age 

who had four diphtheria, tetanus and acellular 

pertussis (DTaP); three polio (IPV), one measles, mumps and rubella (MMR); three H influenza type B (HiB); three hepatitis B (Hep B); one 

chicken pox (VZV); four pneumococcal conjugate (PCV); one hepatitis A (Hep A); two or 

three rotavirus (RV); and two influenza (flu) vaccines by their second birthday. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS, UDS .... ......................... Population/Public 

Health. 

NQF 0041 .................. Title: Preventative Care and Screening: Influenza 

Immunization.

Description: Percentage of patients aged 6 months 

and older seen for a visit between October 1 and 

March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org.

EHR PQRS, ACO, 

Group Reporting 

PQRS.

......................... Population/Public 

Health. 

NQF 0043 .................. Title: Pneumonia Vaccination Status for Older 

Adults.

Description: Percentage of patients 65 years of 

age and older who have ever received a pneumococcal vaccine. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS, ACO, 

Group Reporting 

PQRS, NCQA– 

PCMH Recognition.

......................... Clinical Process/Effectiveness. 

NQF 0052* ................. Title: Use of Imaging Studies for Low Back Pain ....

Description: Percentage of patients 18–50 years of 

age with a diagnosis of low back pain who did 

not have an imaging study (plain X-ray, MRI, CT 

scan) within 28 days of the diagnosis. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS .............. ......................... Efficient Use of 

Healthcare Resources. 

NQF 0055 .................. Title: Diabetes: Eye Exam .......................................

Description: Percentage of patients 18–75 years of 

age with diabetes who had a retinal or dilated 

eye exam by an eye care professional during the 

measurement period or a negative retinal exam 

(no evidence of retinopathy) in the 12 months 

prior to the measurement period. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS, Group 

Reporting PQRS.

......................... Clinical Process/Effectiveness. 

NQF 0056 .................. Title: Diabetes: Foot Exam ......................................

Description: Percentage of patients aged 18–75 

years of age with diabetes who had a foot exam 

during the measurement period. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS, Group 

Reporting PQRS.

......................... Clinical Process/Effectiveness. 

NQF 0059 .................. Title: Diabetes: Hemoglobin A1c Poor Control ........

Description: Percentage of patients 18–75 years of 

age with diabetes who had hemoglobin A1c 

>9.0% during the measurement period. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS, ACO, 

Group Reporting 

PQRS, UDS.

......................... Clinical Process/Effectiveness. 

NQF 0060 .................. Title: Hemoglobin A1c Test for Pediatric Patients ...

Description: Percentage of patients 5–17 years of 

age with diabetes with an HbA1c test during the 

measurement period. 

NCQA Contact Information: 

www.ncqa.org.

.................................. New ................. Clinical Process/Effectiveness. 

NQF 0062 .................. Title: Diabetes: Urine Protein Screening .................

Description: The percentage of patients 18–75 

years of age with diabetes who had a 

nephropathy screening test or evidence of 

nephropathy during the measurement period. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS, Group 

Reporting PQRS.

......................... Clinical Process/Effectiveness. 

NQF 0064 .................. Title: Diabetes: Low Density Lipoprotein (LDL) 

Management.

Description: Percentage of patients 18–75 years of 

age with diabetes whose LDL–C was adequately 

controlled (<100 mg/dL) during the measurement 

period. 

NCQA Contact Information: 

www.ncqa.org.

PQRS, Group Reporting PQRS.......................... Clinical Process/Effectiveness. 

NQF 0068 .................. Title: Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic.

Description: Percentage of patients 18 years of 

age and older who were discharged alive for 

acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous coronary interventions (PCI) in the 12 months prior to 

the measurement period, or who had an active 

diagnosis of ischemic vascular disease (IVD) 

during the measurement period, and who had 

documentation of use of aspirin or another 

antithrombotic during the measurement period. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS, ACO, 

Group Reporting 

PQRS.

......................... Clinical Process/Effectiveness. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54071 

TABLE 8—CQMS FINALIZED FOR MEDICARE AND MEDICAID EPS BEGINNING WITH CY 2014—Continued 

CQM No. CQM title and description Measure steward and 

contact information 

Other quality measure 

programs that use the 

same CQM*** 

New CQM Domain 

NQF 0069 ** .............. Title: Appropriate Treatment for Children with 

Upper Respiratory Infection (URI).

Description: Percentage of children 3 months–18 

years of age who were diagnosed with upper 

respiratory infection (URI) and were not dispensed an antibiotic prescription on or three 

days after the episode. 

NCQA Contact Information: 

www.ncqa.org.

PQRS, NCQA– 

PCMH Recognition.

New ................. Efficient Use of 

Healthcare Resources. 

NQF 0070 .................. Title: Coronary Artery Disease (CAD): Beta-Blocker 

Therapy—Prior Myocardial Infarction (MI) or Left 

Ventricular Systolic Dysfunction (LVEF <40%).

Description: Percentage of patients aged 18 years 

and older with a diagnosis of coronary artery disease seen within a 12 month period who also 

have a prior MI or a current or prior LVEF <40% 

who were prescribed beta-blocker therapy. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org.

EHR PQRS, NCQA– 

PCMH Recognition.

......................... Clinical Process/Effectiveness. 

NQF 0075 .................. Title: Ischemic Vascular Disease (IVD): Complete 

Lipid Panel and LDL Control.

Description: Percentage of patients 18 years of 

age and older who were discharged alive for 

acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous coronary interventions (PCI) in the 12 months prior to 

the measurement period, or who had an active 

diagnosis of ischemic vascular disease (IVD) 

during the measurement period, and who had a 

complete lipid profile performed during the measurement period and whose LDL–C was adequately controlled (<100 mg/dL). 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS, ACO, 

Group Reporting 

PQRS.

......................... Clinical Process/Effectiveness. 

NQF 0081 .................. Title: Heart Failure (HF): Angiotensin-Converting 

Enzyme (ACE) Inhibitor or Angiotensin Receptor 

Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD).

AMA–PCPI Contact 

Information: 

cpe@amaassn.org.

EHR PQRS, Group 

Reporting PQRS, 

NCQA–PCMH 

Recognition.

......................... Clinical Process/Effectiveness 

Description: Percentage of patients aged 18 years 

and older with a diagnosis of heart failure (HF) 

with a current or prior left ventricular ejection 

fraction (LVEF) <40% who were prescribed ACE 

inhibitor or ARB therapy either within a 12 month 

period when seen in the outpatient setting OR at 

each hospital discharge.

NQF 0083 .................. Title: Heart Failure (HF): Beta-Blocker Therapy for 

Left Ventricular Systolic Dysfunction (LVSD).

Description: Percentage of patients aged 18 years 

and older with a diagnosis of heart failure (HF) 

with a current or prior left ventricular ejection 

fraction (LVEF) <40% who were prescribed betablocker therapy either within a 12 month period 

when seen in the outpatient setting OR at each 

hospital discharge. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org.

EHR PQRS, ACO, 

Group Reporting 

PQRS.

......................... Clinical Process/Effectiveness. 

NQF 0086 .................. Title: Primary Open Angle Glaucoma (POAG): 

Optic Nerve Evaluation.

Description: Percentage of patients aged 18 years 

and older with a diagnosis of POAG who have 

an optic nerve head evaluation during one or 

more office visits within 12 months. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org.

EHR PQRS .............. ......................... Clinical Process/Effectiveness. 

NQF 0088 .................. Title: Diabetic Retinopathy: Documentation of Presence or Absence of Macular Edema and Level of 

Severity of Retinopathy.

Description: Percentage of patients aged 18 years 

and older with a diagnosis of diabetic retinopathy 

who had a dilated macular or fundus exam performed which included documentation of the 

level of severity of retinopathy and the presence 

or absence of macular edema during one or 

more office visits within 12 months. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org.

EHR PQRS .............. ......................... Clinical Process/Effectiveness. 

NQF 0089 .................. Title: Diabetic Retinopathy: Communication with 

the Physician Managing Ongoing Diabetes Care.

Description: Percentage of patients aged 18 years 

and older with a diagnosis of diabetic retinopathy 

who had a dilated macular or fundus exam performed with documented communication to the 

physician who manages the ongoing care of the 

patient with diabetes mellitus regarding the findings of the macular or fundus exam at least once 

within 12 months. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org.

EHR PQRS .............. ......................... Clinical Process/Effectiveness. 

mstockstill on DSK4VPTVN1PROD with RULES2

54072 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 8—CQMS FINALIZED FOR MEDICARE AND MEDICAID EPS BEGINNING WITH CY 2014—Continued 

CQM No. CQM title and description Measure steward and 

contact information 

Other quality measure 

programs that use the 

same CQM*** 

New CQM Domain 

NQF 0101 .................. Title: Falls: Screening for Future Fall Risk ..............

Description: Percentage of patients 65 years of 

age and older who were screened for future fall 

risk during the measurement period. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org; NCQA 

Contact Information: www.ncqa.org.

PQRS, ACO, Group 

Reporting PQRS.

New ................. Patient Safety. 

NQF 0104 .................. Title: Major Depressive Disorder (MDD): Suicide 

Risk Assessment.

Description: Percentage of patients aged 18 years 

and older with a new diagnosis or recurrent episode of MDD who had a suicide risk assessment 

completed at each visit during the measurement 

period. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org.

PQRS ....................... New ................. Clinical Process/Effectiveness. 

NQF 0105 .................. Title: Anti–depressant Medication Management .....

Description: Percentage of patients 18 years of 

age and older who were diagnosed with major 

depression and treated with antidepressant 

medication, and who remained on 

antidepressant medication treatment. Two rates 

are reported. 

NCQA Contact Information: 

www.ncqa.org.

EHR PQRS, HEDIS, 

state use, ACA 

2701.

......................... Clinical Process/Effectiveness. 

a. Percentage of patients who remained on an 

antidepressant medication for at least 84 days 

(12 weeks).

b. Percentage of patients who remained on an 

antidepressant medication for at least 180 days 

(6 months).

NQF 0108** ............... Title: ADHD: Follow-Up Care for Children Prescribed Attention-Deficit/Hyperactivity Disorder 

(ADHD) Medication.

Description: Percentage of children 6–12 years of 

age and newly dispensed a medication for attention-deficit/hyperactivity disorder (ADHD) who 

had appropriate follow-up care. Two rates are reported. 

NCQA Contact Information: 

www.ncqa.org.

.................................. New ................. Clinical Process/Effectiveness. 

a. Percentage of children who had one follow-up 

visit with a practitioner with prescribing authority 

during the 30-Day Initiation Phase.

b. Percentage of children who remained on ADHD 

medication for at least 210 days and who, in addition to the visit in the Initiation Phase, had at 

least two additional follow-up visits with a practitioner within 270 days (9 months) after the Initiation Phase ended.

NQF 0110 .................. Title: Bipolar Disorder and Major Depression: Appraisal for alcohol or chemical substance use.

Description: Percentage of patients with depression 

or bipolar disorder with evidence of an initial assessment that includes an appraisal for alcohol 

or chemical substance use. 

Center for Quality 

Assessment and 

Improvement in 

Mental Health 

(CQAIMH) Contact 

Information: 

www.cqaimh.org; 

cqaimh@cqaimh.org.

NCQA–PCMH Recognition.New ................. Clinical Process/Effectiveness. 

NQF 0384 .................. Title: Oncology: Medical and Radiation—Pain Intensity Quantified.

Description: Percentage of patient visits, regardless 

of patient age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy in which pain intensity is quantified. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org.

PQRS ....................... New ................. Patient and Family 

Engagement. 

NQF 0385 .................. Title: Colon Cancer: Chemotherapy for AJCC 

Stage III Colon Cancer Patients.

Description: Percentage of patients aged 18 

through 80 years with Stage III colon cancer who 

are referred for adjuvant chemotherapy, prescribed adjuvant chemotherapy, or have previously received adjuvant chemotherapy within 

the 12-month reporting period. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org;American 

Society of Clinical 

Oncology (ASCO): 

www.asco.org; National Comprehensive Cancer Network (NCCN): 

www.nccn.org.

EHR PQRS .............. ......................... Clinical Process/Effectiveness. 

NQF 0387 .................. Title: Breast Cancer: Hormonal Therapy for Stage 

IC–IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer.

Description: Percentage of female patients aged 18 

years and older with Stage IC through IIIC, ER 

or PR positive breast cancer who were prescribed tamoxifen or aromatase inhibitor (AI) during the 12-month reporting period. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org; ASCO: 

www.asco.org; 

NCCN: 

www.nccn.org.

EHR PQRS .............. ......................... Clinical Process/Effectiveness. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54073 

TABLE 8—CQMS FINALIZED FOR MEDICARE AND MEDICAID EPS BEGINNING WITH CY 2014—Continued 

CQM No. CQM title and description Measure steward and 

contact information 

Other quality measure 

programs that use the 

same CQM*** 

New CQM Domain 

NQF 0389 .................. Title: Prostate Cancer: Avoidance of Overuse of 

Bone Scan for Staging Low Risk Prostate Cancer Patients.

Description: Percentage of patients, regardless of 

age, with a diagnosis of prostate cancer at low 

risk of recurrence receiving interstitial prostate 

brachytherapy, OR external beam radiotherapy 

to the prostate, OR radical prostatectomy, OR 

cryotherapy who did not have a bone scan performed at any time since diagnosis of prostate 

cancer. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org.

EHR PQRS .............. ......................... Efficient Use of 

Healthcare Resources. 

NQF 0403 .................. Title: HIV/AIDS: Medical Visit ..................................

Description: Percentage of patients, regardless of 

age, with a diagnosis of HIV/AIDS with at least 

two medical visits during the measurement year 

with a minimum of 60 days between each visit. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org; NCQA 

Contact Information: www.ncqa.org.

.................................. New ................. Clinical Process/Effectiveness. 

NQF 0405 .................. Title: HIV/AIDS: Pneumocystis jiroveci pneumonia 

(PCP) Prophylaxis.

Description: Percentage of patients aged 6 weeks 

and older with a diagnosis of HIV/AIDS who 

were prescribed Pneumocystis jiroveci pneumonia (PCP) prophylaxis. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org; NCQA 

Contact Information: www.ncqa.org.

PQRS, NCQA– 

PCMH Recognition.

New ................. Clinical Process/Effectiveness. 

TBD (proposed as 

NQF 0407).

Title: HIV/AIDS: RNA control for Patients with HIV

Description: Percentage of patients aged 13 years 

and older with a diagnosis of HIV/AIDS, with at 

least two visits during the measurement year, 

with at least 60 days between each visit, whose 

most recent HIV RNA level is <200 copies/mL. 

NCQA Contact Information: 

www.ncqa.org.

PQRS ....................... New ................. Clinical Process/Effectiveness. 

NQF 0418*** .............. Title: Preventive Care and Screening: Screening 

for Clinical Depression and Follow-Up Plan.

Description: Percentage of patients aged 12 years 

and older screened for clinical depression on the 

date of the encounter using an age appropriate 

standardized depression screening tool AND if 

positive, a follow-up plan is documented on the 

date of the positive screen. 

Centers for Medicare 

and Medicaid 

Services (CMS) 1– 

888–;734–6433 or 

http://questions.

cms.hhs.gov/app/ 

ask/p/21,26,1139; 

Quality Insights of 

Pennsylvania 

(QIP) Contact Information: 

www.usquality

measures.org.

EHR PQRS, ACO, 

Group Reporting 

PQRS.

New ................. Population/Public 

Health. 

NQF 0419* ................. Title: Documentation of Current Medications in the 

Medical Record.

Description: Percentage of specified visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of 

current medications to the best of his/her knowledge and ability. This list must include ALL prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements 

AND must contain the medications’ name, dosage, frequency and route of administration. 

Centers for Medicare 

and Medicaid 

Services (CMS) 1–

888–734–6433 or 

http://questions.cms.hhs.gov/ 

app/ask/p/

21,26,1139; QIP 

Contact Information: www.usquality

measures.org.

PQRS, EHR PQRS .. New ................. Patient Safety. 

NQF 0421* ................. Title: Preventive Care and Screening: Body Mass 

Index (BMI) Screening and Follow-Up.

Description: Percentage of patients aged 18 years 

and older with a calculated BMI in the past six 

months or during the current reporting period 

documented in the medical record AND if the 

most recent BMI is outside of normal parameters, a follow-up plan is documented within the 

past six months or during the current reporting 

period. 

Normal Parameters: Age 65 years and older BMI 

≥23 and <30. 

Age 18–64 years BMI ≥18.5 and <25. 

Centers for Medicare 

and Medicaid 

Services (CMS) 1– 

888–734–6433 or 

http://questions.

cms.hhs.gov/app/

ask/p/21,26,1139; 

QIP Contact Information: 

www.usquality

measures.org.

EHR PQRS, ACO, 

Group Reporting 

PQRS, UDS.

......................... Population/Public 

Health. 

NQF 0564 .................. Title: Cataracts: Complications within 30 Days Following Cataract Surgery Requiring Additional 

Surgical Procedures.

Description: Percentage of patients aged 18 years 

and older with a diagnosis of uncomplicated cataract who had cataract surgery and had any of a 

specified list of surgical procedures in the 30 

days following cataract surgery which would indicate the occurrence of any of the following major 

complications: retained nuclear fragments, 

endophthalmitis, dislocated or wrong power IOL, 

retinal detachment, or wound dehiscence. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org; NCQA 

Contact Information: www.ncqa.org.

PQRS ....................... New ................. Patient Safety. 

mstockstill on DSK4VPTVN1PROD with RULES2

54074 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 8—CQMS FINALIZED FOR MEDICARE AND MEDICAID EPS BEGINNING WITH CY 2014—Continued 

CQM No. CQM title and description Measure steward and 

contact information 

Other quality measure 

programs that use the 

same CQM*** 

New CQM Domain 

NQF 0565 .................. Title: Cataracts: 20/40 or Better Visual Acuity within 90 Days Following Cataract Surgery.

Description: Percentage of patients aged 18 years 

and older with a diagnosis of uncomplicated cataract who had cataract surgery and no significant ocular conditions impacting the visual outcome of surgery and had best-corrected visual 

acuity of 20/40 or better (distance or near) 

achieved within 90 days following the cataract 

surgery. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org; NCQA 

Contact Information: www.ncqa.org.

PQRS ....................... New ................. Clinical Process/Effectiveness. 

NQF 0608 .................. Title: Pregnant women that had HBsAg testing ......

Description: This measure identifies pregnant 

women who had a HBsAg (hepatitis B) test during their pregnancy. 

Ingenix Contact Information: 

www.ingenix.com.

.................................. New ................. Clinical Process/Effectiveness. 

NQF 0710 .................. Title: Depression Remission at Twelve Months ......

Description: Adult patients age 18 and older with 

major depression or dysthymia and an initial 

PHQ–9 score >9 who demonstrate remission at 

twelve months defined as PHQ–9 score less 

than 5. This measure applies to both patients 

with newly diagnosed and existing depression 

whose current PHQ–9 score indicates a need for 

treatment. 

Minnesota Community Measurement 

(MNCM) Contact 

Information: 

www.mncm.org; 

info@mncm.org.

.................................. New ................. Clinical Process/Effectiveness. 

NQF 0712 .................. Title: Depression Utilization of the PHQ–9 Tool ......

Description: Adult patients age 18 and older with 

the diagnosis of major depression or dysthymia 

who have a PHQ–9 tool administered at least 

once during a 4 month period in which there was 

a qualifying visit. 

MNCM Contact Information: 

www.mncm.org; 

info@mncm.org.

.................................. New ................. Clinical Process/Effectiveness. 

TBD ** ........................ Title: Children who have dental decay or cavities ...

Description: Percentage of children ages 0–20, 

who have had tooth decay or cavities during the 

measurement period. 

Maternal and Child 

Health Bureau, 

Health Resources 

and Services Administration http:// 

mchb.hrsa.gov/.

.................................. New ................. Clinical Process/Effectiveness. 

NQF 1365 .................. Title: Child and Adolescent Major Depressive Disorder: Suicide Risk Assessment.

Description: Percentage of patient visits for those 

patients aged 6 through 17 years with a diagnosis of major depressive disorder with an assessment for suicide risk. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org.

.................................. New ................. Patient Safety. 

NQF 1401 .................. Title: Maternal depression screening .......................

Description: The percentage of children who turned 

6 months of age during the measurement year, 

who had a face-to-face visit between the clinician and the child during child’s first 6 months, 

and who had a maternal depression screening 

for the mother at least once between 0 and 6 

months of life. 

NCQA Contact Information: 

www.ncqa.org.

.................................. New ................. Population/Public 

Health. 

TBD ............................ Title: Primary Caries Prevention Intervention as Offered by Primary Care Providers, including Dentists.

Description: Percentage of children, age 0–20 

years, who received a fluoride varnish application during the measurement period. 

University of Minnesota Contact Information: 

www.umn.edu.

.................................. New ................. Clinical Process/Effectiveness. 

TBD ............................ Title: Preventive Care and Screening: Cholesterol—Fasting Low Density Lipoprotein (LDL–C) 

Test Performed.

Description: Percentage of patients aged 20 

through 79 years whose risk factors have been 

assessed and a fasting LDL–C test has been 

performed. 

CMS 1–888–734– 

6433 or http://

questions.cms.hhs.

gov/app/ask/p/

21,26,1139; QIP 

Contact Information: www.usquality

measures.org.

EHR PQRS .............. New ................. Clinical Process/Effectiveness. 

TBD ............................ Title: Preventive Care and Screening: Risk-Stratified Cholesterol—Fasting Low Density 

Lipoprotein (LDL–C).

Description: Percentage of patients aged 20 

through 79 years who had a fasting LDL–C test 

performed and whose risk-stratified fasting LDL– 

C is at or below the recommended LDL–C goal. 

CMS 1–888–734– 

6433 or http://

questions.cms.hhs.

gov/app/ask/p/21,

26,1139; QIP Contact Information: 

www.usquality

measures.org.

EHR PQRS .............. New ................. Clinical Process/Effectiveness. 

TBD ............................ Title: Dementia: Cognitive Assessment ...................

Description: Percentage of patients, regardless of 

age, with a diagnosis of dementia for whom an 

assessment of cognition is performed and the results reviewed at least once within a 12 month 

period. 

AMA–PCPI Contact 

Information: 

cpe@amaassn.org.

PQRS ....................... New ................. Clinical Process/Effectiveness. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54075 

TABLE 8—CQMS FINALIZED FOR MEDICARE AND MEDICAID EPS BEGINNING WITH CY 2014—Continued 

CQM No. CQM title and description Measure steward and 

contact information 

Other quality measure 

programs that use the 

same CQM*** 

New CQM Domain 

TBD ............................ Title: Hypertension: Improvement in blood pressure 

Description: Percentage of patients aged 18–85 

years of age with a diagnosis of hypertension 

whose blood pressure improved during the 

measurement period. 

CMS 1–888–734– 

6433 or http://

questions.cms.hhs.

gov/app/ask/p/21,

26,1139.

.................................. New ................. Clinical Process/Effectiveness. 

TBD* .......................... Title: Closing the referral loop: receipt of specialist 

report.

Description: Percentage of patients with referrals, 

regardless of age, for which the referring provider receives a report from the provider to 

whom the patient was referred. 

CMS 1–888–734– 

6433 or http://

questions.cms.hhs.

gov/app/ask/p/21,

26,1139.

.................................. New ................. Care Coordination. 

TBD ............................ Title: Functional status assessment for knee replacement.

Description: Percentage of patients aged 18 years 

and older with primary total knee arthroplasty 

(TKA) who completed baseline and follow-up 

(patient-reported) functional status assessments. 

CMS 1–888–734– 

6433 or http://

questions.cms.

hhs.gov/app/ask/p/

21,26,1139.

.................................. New ................. Patient and Family 

Engagement. 

TBD ............................ Title: Functional status assessment for hip replacement.

Description: Percentage of patients aged 18 years 

and older with primary total hip arthroplasty 

(THA) who completed baseline and follow-up 

(patient-reported) functional status assessments. 

CMS 1–888–734– 

6433 or http://

questions.cms.hhs.

gov/app/ask/p/21,

26,1139.

.................................. New ................. Patient and Family 

Engagement. 

TBD* .......................... Title: Functional status assessment for complex 

chronic conditions.

Description: Percentage of patients aged 65 years 

and older with heart failure who completed initial 

and follow-up patient-reported functional status 

assessments. 

CMS 1–888–734– 

6433 or http://

questions.cms.

hhs.gov/app/ask/p/

21,26,1139.

.................................. New ................. Patient and Family 

Engagement. 

TBD ............................ Title: ADE Prevention and Monitoring: Warfarin 

Time in Therapeutic Range.

Description: Average percentage of time in which 

individuals with atrial fibrillation who are on 

chronic anticoagulation have International Normalized Ratio (INR) test results within the therapeutic range during the measurement period. 

CMS 1–888–734– 

6433 or http://

questions.cms.hhs.

gov/app/ask/p/21,

26,1139.

.................................. New ................. Patient Safety. 

TBD ............................ Title: Preventive Care and Screening: Screening 

for High Blood Pressure and Follow-Up Documented.

Description: Percentage of patients aged 18 years 

and older seen during the reporting period who 

were screened for high blood pressure AND a 

recommended follow-up plan is documented 

based on the current blood pressure (BP) reading as indicated. 

CMS 1–888–734– 

6433 or http://

questions.cms.hhs.

gov/app/ask/p/21,

26,1139; QIP Contact Information: 

www.usquality

measures.org.

PQRS, EHR PQRS, 

Group Reporting 

PQRS, ACO.

New ................. Population/Public 

Health. 

* Recommended Adult Core CQMs for EPs. 

** Recommended Pediatric Core CQMs for EPs. 

*** PQRS = Physician Quality Reporting System. 

EHR PQRS = Physician Quality Reporting System’s Electronic Health Record Reporting Option. 

CHIPRA = Children’s Health Insurance Program Reauthorization Act. 

HEDIS = Healthcare Effectiveness Data and Information Set. 

ACA 2701 = Affordable Care Act section 2701. 

NCQA–PCMH = National Committee for Quality Assurance—Patient Centered Medical Home. 

Group Reporting PQRS = Physician Quality Reporting System’s Group Reporting Option. 

UDS = Uniform Data System (Health Resources Services Administration). 

ACO = Accountable Care Organization (Medicare Shared Savings Program). 

6. Reporting Methods for CQMs for EPs 

(a) Reporting Methods for Medicaid EPs 

For Medicaid EPs, we stated in the 

proposed rule that states are, and will 

continue in Stage 2 to be, responsible 

for determining whether and how 

electronic reporting would occur, or 

whether they wish to continue to allow 

reporting through attestation. If a state 

does require such electronic reporting, 

the state is responsible for sharing the 

details of the process with its provider 

community. We stated that we 

anticipate that whatever means states 

have deployed for capturing Stage 1 

CQMs electronically would be similar 

for reporting in CY 2013. However, we 

note that subject to our prior approval, 

this is within the states’ purview. 

Beginning in CY 2014, we proposed that 

the states would establish the method 

and requirements, subject to CMS prior 

approval, for the electronic capture and 

reporting of CQMs from CEHRT. 

Comment: Commenters suggested 

unified Medicaid CQM reporting to 

reduce the burden on EPs operating in 

multiple states. 

Response: For the purposes of the 

Medicaid EHR Incentive Program, EPs 

report CQMs to the state making the 

EHR incentive payment. However, data 

from all practice locations that are 

equipped with CEHRT will be used for 

reporting CQMs, even if the practice 

locations are in different states. 

After consideration of the public 

comments received, we are finalizing 

the policies for electronic reporting of 

CQMs for Medicaid EPs as proposed. As 

part of certification for EHR technology, 

ONC is including testing for data 

capture, CQM calculation, and 

electronic submission. For CQMs, this 

includes certification criteria for the 

QRDA Category I (QRDA–I) and QRDA 

Category III (QRDA–III) transmission 

formats. We expect the states that have 

electronic reporting options for CQMs 

might choose to adopt QRDA–I for 

patient-level data and/or QRDA–III for 

aggregate data as the form in which EPs 

would report CQM data. By adopting 

the same QRDA–I and/or QRDA–III that 

mstockstill on DSK4VPTVN1PROD with RULES2

54076 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

CMS is requiring for CQM reporting, the 

states would be able to leverage the 

development of the specifications by 

CMS and the industry as well as the 

testing done by ONC for certification of 

EHR technology. This would reduce the 

burden on EHR vendors to implement 

and test different specifications. 

(b) Reporting Methods for Medicare EPs 

in CY 2013 

In the Stage 2 proposed rule, we did 

not propose any reporting methods for 

Medicare EPs in 2013. However, in the 

CY 2013 Medicare PFS proposed rule 

(77 FR 44988), we proposed that EPs 

may continue to report by attestation 

CQM results as calculated by CEHRT, as 

they did for 2011 and 2012. For further 

explanation of reporting CQMs by 

attestation, please see the Stage 1 final 

rule (75 FR 44430 through 44434). We 

also proposed in the CY 2013 Medicare 

PFS proposed rule (77 FR 44988) to 

continue the voluntary electronic 

reporting pilot for CQMs (the PQRS— 

Medicare EHR Incentive Pilot) for 2013, 

which we had previously established for 

2012. We expect to finalize in the CY 

2013 Medicare PFS final rule the 

reporting methods that would apply in 

2013 for EPs participating in the 

Medicare EHR Incentive Program. 

(c) Reporting Methods for Medicare EPs 

Beginning With CY 2014 

Under section 1848(o)(2)(A)(iii) of the 

Act, EPs must submit information on 

the CQMs selected by the Secretary ‘‘in 

a form and manner specified by the 

Secretary’’ as part of demonstrating 

meaningful use of CEHRT. We proposed 

that Medicare EPs who are in their first 

year of Stage 1 may report CQMs 

through attestation for a continuous 90- 

day EHR reporting period. We proposed 

that Medicare EPs who choose Option 1 

for reporting CQMs would submit 

through an aggregate reporting method, 

which would require the EP to log into 

a CMS-designated portal and submit 

through an upload process data 

produced as output from their CEHRT 

in an XML-based format specified by 

CMS. We proposed that Medicare EPs 

who choose to report CQMs as 

described in Option 2 would submit in 

accordance with the requirements of the 

PQRS program. 

Comment: We received several 

comments on the proposal to use an 

XML-based format for transmitting 

aggregate results. Those commenters 

were generally in favor of using an 

aggregate XML and that the technical 

structure aligns with the PQRS registry 

reporting option. One commenter noted 

that the aggregate-level standard QRDA– 

III is not currently mature. Some 

commenters indicated a preference that 

the aggregate reporting method should 

only require submission of one data file 

instead of multiple files, citing that 

submitting multiple files is onerous and 

may not be manageable due to the 

number of files EPs would need to 

upload. 

Response: We acknowledge that there 

is currently no consensus standard for 

the electronic transmission of aggregate 

results of CQMs. However, the 2014 

Edition certification criteria adopt the 

QRDA–III specification. As a result, we 

expect to be able to receive data 

submitted using the QRDA–III 

specification. 

We proposed to consider an ‘‘interim 

submission’’ option for Medicare EPs 

who are in their first year of Stage 1 and 

who participate in PQRS. Under this 

option, EPs would submit the PQRS 

CQM data for a continuous 90-day EHR 

reporting period, and the data must be 

received no later than October 1 to meet 

the requirements of the EHR Incentive 

Program. We proposed that the EP 

would report the remainder of his/her 

CQM data by the deadline specified for 

PQRS in order to meet the requirements 

of the PQRS program. We solicited 

public comment on this potential 

option. 

Comment: Many commenters 

indicated the proposed interim 

submission option for Medicare EPs in 

their first year of Stage 1 is unclear and 

would involve a prohibitive amount of 

effort. The commenters also suggested 

removing this option. Other commenters 

supported the interim submission 

option. 

Response: This option was intended 

to accommodate Medicare EPs who are 

demonstrating meaningful use for the 

first time in 2014 and want to choose 

Option 2 (the PQRS EHR reporting 

option) for reporting CQMs. As 

proposed, however, it would require 

two submissions. We agree with the 

commenters that the ‘‘interim 

submission option’’ is complex and 

potentially burdensome. We are not 

finalizing the interim submission 

option. 

After consideration of the public 

comments received, we are finalizing 

the following reporting methods for 

Medicare EPs beginning in CY 2014: 

• Option 1: Aggregate reporting 

through a CMS-designated electronic 

transmission method using CEHRT. 

The format required for aggregate 

reporting will be the QRDA–III, which 

is an XML-based format. The electronic 

transmission method for aggregate 

reporting differs from reporting via 

attestation in that the QRDA–III report 

would be generated by the EPs CEHRT 

and transmitted electronically rather 

than the aggregate results manually 

input into the Registration and 

Attestation system. EPs who are in their 

first year of Stage 1 must report CQMs 

under Option 1 through attestation 

(please refer to the Stage 1 final rule for 

an explanation of reporting CQMs 

through attestation (75 FR 44430 

through 44434)). Consistent with section 

1848(o)(2)(B)(ii) of the Act, in the 

unlikely event that the Secretary does 

not have the capacity to receive CQM 

data electronically, EPs who are beyond 

the first year of Stage 1 may continue to 

report aggregate CQM results through 

attestation. 

• Option 2: Patient-level reporting via 

PQRS through the transmission methods 

established for the PQRS EHR-based 

reporting mechanisms and using 

CEHRT. 

Please refer to 42 CFR 414.90 and the 

CY 2013 Medicare PFS proposed rule 

(77 FR 44988) for more information on 

the PQRS. 

(d) Group Reporting Option for 

Medicare and Medicaid EPs Beginning 

With CY 2014 

For Stage 1, EPs were required to 

report the CQMs on an individual basis 

and did not have an option to report the 

CQMs as part of a group practice. Under 

section 1848(o)(2)(A) of the Act, the 

Secretary may provide for the use of 

alternative means for EPs furnishing 

covered professional services in a group 

practice (as defined by the Secretary) to 

meet the requirements of meaningful 

use. Beginning with CY 2014, we 

proposed three group reporting options 

to allow EPs within a single group 

practice to report CQM data on a group 

level. We proposed that all three 

methods would be available for 

Medicare EPs, while only the first one 

would be possible for Medicaid EPs, at 

states’ discretion. 

We proposed each of these options as 

an alternative to reporting CQM data as 

an individual EP under the proposed 

options and reporting methods 

discussed earlier in this rule. These 

group reporting options would only be 

available for reporting CQMs for 

purposes of the EHR Incentive Program 

and only if all EPs in the group are 

beyond the first year of Stage 1. EPs 

would not be able to use these group 

reporting options for any of the other 

meaningful use objectives and 

associated measures in the EHR 

Incentive Programs. 

The three group reporting options that 

we proposed for EPs are as follows: 

• Two or more EPs, each identified 

with a unique NPI associated with a 

group practice identified under one tax 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54077 

identification number (TIN) may be 

considered an EHR Incentive Group for 

the purposes of reporting CQMs for the 

Medicare EHR Incentive Program. This 

group reporting option would only be 

available for electronic reporting of 

CQMs and would not be available for 

those EPs in their first year of Stage 1. 

The CQMs reported under this option 

would represent all EPs within the 

group. EPs who choose this group 

reporting option for CQMs would have 

to individually satisfy the objectives and 

associated measures for their respective 

stage of meaningful use. We proposed 

that states may also choose this option 

to accept group reporting for CQMs, 

based upon a predetermined definition 

of a ‘‘group practice,’’ such as sharing 

one TIN. 

• Medicare EPs participating in the 

Medicare SSP and the testing of the 

Pioneer ACO model who use CEHRT to 

submit ACO measures in accordance 

with the requirements of the Medicare 

SSP would be considered to have 

satisfied their CQM reporting 

requirement as a group for the Medicare 

EHR Incentive Program. The Medicare 

SSP does not require the use of CEHRT. 

However, all CQM data would have to 

be extracted from CEHRT in order for 

the EP to qualify for the Medicare EHR 

Incentive Program if an EP intends to 

use this group reporting option. EPs 

would have to individually satisfy the 

objectives and associated measures for 

their respective stage of meaningful use, 

in addition to submitting CQMs as part 

of an ACO. EPs who are part of an ACO 

but do not enter the data used for 

reporting the CQMs (which excludes the 

survey tool or claims-based measures 

that are collected to calculate the quality 

performance score in the Medicare SSP) 

into CEHRT would not be able to meet 

meaningful use requirements. For more 

information about the requirements of 

the Medicare SSP, see 42 CFR 425 and 

the November 2, 2011 final rule (76 FR 

67802). EPs who use this group 

reporting option for the Medicare EHR 

Incentive Program would be required to 

comply with any changes to the 

Medicare SSP that may apply in the 

future. EPs would be required to be part 

of a group practice (that is, two or more 

EPs, each identified with a unique NPI 

associated with a group practice 

identified under one TIN) to be able to 

use this group reporting option. 

• Medicare EPs who satisfactorily 

report PQRS CQMs using CEHRT under 

the PQRS Group Practice Reporting 

Option (GPRO), would be considered to 

have satisfied their CQM reporting 

requirement as a group for the Medicare 

EHR Incentive Program. For more 

information about the PQRS GPRO, see 

42 CFR 414.90 and the CY 2012 

Medicare PFS final rule (76 FR 73314) 

and CY 2013 Medicare PFS proposed 

rule (77 FR 44805 through 44807). EPs 

who use this group reporting option for 

the Medicare EHR Incentive Program 

would be required to comply with any 

changes to the PQRS GPRO that may 

apply in the future and would have to 

individually satisfy the objectives and 

associated measures for their respective 

stage of meaningful use. 

Comment: We received numerous 

comments on the proposed group 

reporting options. Generally, most 

commenters supported including group 

reporting. Many commenters indicated 

group reporting options are consistent 

with the intent of many of the measures 

and would promote a more patient 

focused healthcare experience. A 

commenter requested clarification 

regarding whether group reporting was 

confined to CQMs or other objectives in 

meaningful use as well. Other 

commenters requested more detail on 

how new EPs or EPs leaving group 

practices might affect reporting and 

validation. Commenters indicated the 

requirement that only EPs beyond Stage 

1 be able to use this option be 

eliminated because new providers join 

practices frequently. A commenter 

requested that new members of a 

practice be able to report at the same 

level that the group is currently 

reporting. Many commenters requested 

greater specificity in the final rule and 

clarification whether all EPs under the 

same TIN need to submit as a group, or 

if some can submit as a group and 

others individually. A commenter 

recommended that not all EPs under the 

same TIN should have to have access to 

CEHRT at all group practice locations. 

Other commenters stated that the 

proposed option for group reporting is 

complex and suggested the files 

submitted contain only data related to 

providers within the group or practice 

that have met the measures. A 

commenter indicated that the addition 

of multiple reporting options has made 

it exceedingly difficult for providers 

already presented with multiple 

reporting options across state and 

federal programs. 

Response: We agree with commenters 

as to the benefits of reporting and 

measurement at the group level. We 

believe it can lessen the complexity and 

burden of reporting and also promote a 

greater patient focus. Group level 

reporting can avoid the need for 

multiple professionals in the same 

practice to report the same information 

on single patient that they may each 

treat. It can promote team work and the 

recognition that quality care often 

depends on interplay of multiple 

professionals rather that solely on a 

particular individual professional. 

Therefore, we agree that we should 

include the option of group reporting of 

CQMs for the EHR Incentive Program. 

With respect to applicability to 

measures other than CQMs, as proposed 

the group reporting options in section 

II.B.6.d. of the proposed rule (77 FR 

13758) would apply only to CQM 

reporting and not to other meaningful 

use objectives and associated measures. 

EPs reporting CQMs under a group 

reporting option must still attest to the 

meaningful use objectives and 

associated measures individually or 

through the batch reporting process we 

are finalizing in section II.C.1.c of this 

final rule to successfully demonstrate 

meaningful use. 

As for the three options for group 

reporting we proposed, we agree with 

the potential for complexity of group 

reporting under which different 

individuals within a group would be 

treated differently, such as the proposed 

requirement that all EPs in the group 

must be beyond their first year of 

meaningful use. We believe that this 

would be complex and difficult to 

operationalize, so we are not finalizing 

this requirement. We note that for the 

group reporting option under PQRS and 

for professionals participating in the 

Medicare SSP and the testing of the 

Pioneer ACO model, all individuals 

within a group are treated as being part 

of the group for the purposes of quality 

reporting. 

As a result, for the Medicare EHR 

Incentive Program, we are finalizing the 

following two group reporting options 

for the purposes of CQM reporting: 

• Medicare EPs participating in the 

Medicare SSP and the testing of the 

Pioneer ACO model who use CEHRT to 

submit ACO CQMs in accordance with 

the requirements of the Medicare SSP 

would be considered to have satisfied 

their CQM reporting requirement as a 

group for the Medicare EHR Incentive 

Program. 

• Medicare EPs who satisfactorily 

report PQRS CQMs using CEHRT under 

the PQRS GPRO would be considered to 

have satisfied their CQM reporting 

requirement as a group for the Medicare 

EHR Incentive Program. Under the CY 

2013 Medicare PFS proposed rule, 

additional group reporting options are 

proposed. We note that the proposed 

claims and registry options for GPRO, 

which do not involve the use of CEHRT, 

would not satisfy the CQM reporting 

requirement for the EHR Incentive 

Program. However, the options for 

GPRO involving the use of CEHRT, 

which include submissions from 

mstockstill on DSK4VPTVN1PROD with RULES2

54078 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

CEHRT directly to CMS or through a 

data intermediary to CMS, could satisfy 

the CQM reporting requirement for the 

EHR Incentive Program. Under the 

PQRS GPRO, CQM submission is at the 

group level, not at the level of any 

individual EP that is part of the group. 

Each individual EP who is a member of 

the group would meet the CQM 

reporting requirement for the EHR 

Incentive Program if the group meets the 

requirements for PQRS, with the 

exception of the EPs in the group who 

are in their first year of demonstrating 

meaningful use as noted later in this 

section. 

We do not finalize any additional 

requirements beyond those of the 

programs themselves for group 

reporting, with the exception that the 

group must use CEHRT in connection 

with submitting CQMs. Although a 

group may include EPs that are 

demonstrating meaningful use for the 

first time, we emphasize that these EPs 

cannot use either of these group 

reporting options for reporting CQMs for 

the EHR Incentive Program. CQM data 

collected by EPs that are part of a group 

and are in their first year of 

demonstrating meaningful use could 

still be part of the group’s collective 

data submission. However, for purposes 

of avoiding a payment adjustment, EPs 

who are in their first year of 

demonstrating meaningful use in the 

year immediately preceding a payment 

adjustment year must individually 

submit their CQM data by attestation no 

later than October 1 of such preceding 

year. We encourage EPs who would like 

to use the group reporting options 

beginning in 2014 to become 

meaningful EHR users in 2013. Please 

see section II.D.2. of this final rule for 

more details on payment adjustments. 

For the Medicaid EHR Incentive 

Program, the states will have the option 

to allow group reporting of CQMs 

through an update to their State 

Medicaid HIT plan, which must 

describe how they would address the 

issue of EPs who switch group practices 

during an EHR reporting period. 

7. CQMs for Eligible Hospitals and 

Critical Access Hospitals 

(a) Statutory and Other Considerations 

Sections 1886(n)(3)(A)(iii) and 

1903(t)(6)(C) of the Act provide for the 

reporting of CQMs by eligible hospitals 

and CAHs as part of demonstrating 

meaningful use of CEHRT. For further 

explanation of the statutory 

requirements, we refer readers to the 

discussion in our Stage 1 proposed and 

final rules (75 FR 1870 through 1902 

and 75 FR 44380 through 44435, 

respectively). 

Section 1886(n)(3)(B)(i)(I) of the Act 

requires the Secretary to give preference 

to CQMs that have been selected for the 

purpose of applying section 

1886(b)(3)(B)(viii) of the Act (that is, 

measures that have been selected for the 

Hospital Inpatient Quality Reporting 

(IQR) Program) or that have been 

endorsed by the entity with a contract 

with the Secretary under section 1890(a) 

of the Act (namely, the NQF). We 

proposed CQMs for eligible hospitals 

and CAHs for 2013, 2014, and 2015 (and 

potentially subsequent years) that reflect 

this preference, although we note that 

the Act does not require the selection of 

such CQMs for the EHR Incentive 

Programs. CQMs listed in this final rule 

that do not have an NQF identifying 

number are not NQF endorsed. 

Under section 1903(t)(8) of the Act, 

the Secretary must seek, to the 

maximum extent practicable, to avoid 

duplicative requirements from federal 

and state governments for eligible 

hospitals and CAHs to demonstrate 

meaningful use of CEHRT under 

Medicare and Medicaid. Therefore, to 

meet this requirement, we proposed to 

continue our practice from Stage 1 of 

proposed CQMs that would apply for 

both the Medicare and Medicaid EHR 

Incentive Programs. 

In accordance with CMS and HHS 

quality goals as well as the HHS 

National Quality Strategy 

recommendations, the hospital CQMs 

that we proposed beginning with FY 

2014 can be categorized into the 

following six domains, which are 

described in section II.B.3. of this final 

rule: 

• Patient & Family Engagement. 

• Patient Safety. 

• Care Coordination. 

• Population & Public Health. 

• Efficient Use of Healthcare 

Resources. 

• Clinical Process/Effectiveness. 

The selection of CQMs we proposed 

for eligible hospitals and CAHs was 

based on statutory requirements, the 

HITPC’s recommendations, alignment 

with other CMS and national hospital 

quality measurement programs such as 

the Joint Commission, the Medicare 

Hospital Inpatient Quality Reporting 

(IQR) Program and Hospital ValueBased Purchasing (HVBP) Program, the 

National Quality Strategy (NQS), and 

other considerations discussed in 

sections II.B.7.b. and II.B.7.c. of the 

proposed rule. 

Section 1886(n)(3)(B)(iii) of the Act 

requires that in selecting measures for 

eligible hospitals and CAHs, and in 

establishing the form and manner of 

reporting, the Secretary shall seek to 

avoid redundant or duplicative 

reporting with reporting otherwise 

required. In consideration of the 

importance of alignment with other 

measure sets that apply to eligible 

hospitals and CAHs, we analyzed the 

Hospital IQR Program, hospital CQMs 

used by state Medicaid agencies, and 

the Joint Commission’s hospital CQMs 

when selecting the proposed CQMs to 

be reported under the EHR Incentive 

Program. Furthermore, as we noted in 

the proposed rule, we placed emphasis 

on those CQMs that are in line with the 

NQS and the HITPC’s 

recommendations. 

Comment: Many commenters 

supported alignment of measure sets 

and reporting methods with other 

quality reporting programs and agency 

goals, such as Hospital IQR Program, 

HVBP, and NQS. These commenters 

commended CMS’s intentions to reduce 

duplicative requirements between 

programs, prevent hospitals from 

calculating both electronic and paperbased reports for the same CQMs, avoid 

confusion and move towards a single, 

aligned quality reporting mechanism. 

However, several commenters requested 

that we provide a timeline for these 

alignment efforts as well as additional 

clarification regarding how we intend to 

pursue and achieve alignment across 

quality report programs and what this 

means operationally for eligible 

hospitals and CAHs. One commenter 

requested that we also align with the 

Center for Disease Control and 

Prevention’s (CDC’s) National 

Healthcare Safety Network (NHSN) to 

make hospital acquired infections (HAI) 

a national healthcare priority. Other 

commenters requested that we seek 

alignment and accuracy in other areas of 

quality measurement, including 

electronic specifications, data reporting 

methodologies, and vendor certification 

requirements. One commenter also 

urged that we continuously align 

electronic specifications for all CQMs 

across quality reporting programs as 

measure stewards update and maintain 

their CQMs. 

Response: We appreciate the 

supportive comments regarding 

alignment. Our principal goals in 

alignment of the Hospital IQR, and the 

Medicare and Medicaid EHR Incentive 

Programs are to: (1) Provide a single set 

of CQMs for hospital reporting; (2) to 

the extent possible, avoid duplicate 

reporting by hospitals by using a single 

submission for multiple purposes as 

appropriate; and (3) transition from 

manual chart abstraction to automated 

extraction and electronic reporting 

based on the use of EHR technology. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54079 

In the FY 2012 Inpatient Prospective 

Payment Systems/Long-Term Care 

Hospital Prospective Payment System 

(IPPS/LTCH PPS) proposed rule (76 FR 

25893), we stated our intention to 

explore mechanisms for Hospital IQR 

Program data collection using EHRs, 

and gave FY 2015 as an example of 

when hospitals might be able to switch 

to EHR-based reporting of manually 

chart-abstracted Hospital IQR measures. 

The CQMs we are finalizing beginning 

in 2014 for reporting under the EHR 

Incentive Program are electronically 

specified versions of current IQR chart 

abstracted CQMs. The 2015 target date 

would allow for at least 1 year of 

electronic submission of CQMs through 

the EHR Incentive Program prior to our 

targeted date to begin EHR-based 

reporting for IQR. We must assess any 

data collection mode differences 

between EHR-based reporting and chart 

abstracted measures using a diverse and 

robust sample of hospitals before 

proposing in rulemaking to use EHR 

data collection in the Hospital IQR 

program. Among other factors, our 

ability to transition to EHR-based 

reporting for IQR will depend on 

whether EHR-based reporting is 

accurate and reliable. Our goal would be 

to phase out manual chart abstraction 

for hospital reporting. 

We did not propose the IQR CQMs on 

HAI for the EHR Incentive Program. 

Hospitals may electronically submit 

HAI information to the CDC, although 

this is not required. Information of 

electronic submission through the 

NHSN can be found at http:// 

www.cdc.gov/nhsn/ 

CDA_eSurveillance.html. NHSN data is 

based on surveillance data rather than 

chart abstraction. We will consider the 

NHSN measures for the EHR Incentive 

Program in future years. 

(b) CQMs for Eligible Hospitals and 

CAHs for FY 2013 

For the EHR reporting periods in FY 

2013, we proposed to require that 

eligible hospitals and CAHs submit 

information on each of the 15 CQMs 

that were finalized for FYs 2011 and 

2012 in the Stage 1 final rule (75 FR 

44418 through 44420). We refer readers 

to the discussion in the Stage 1 final 

rule for further explanation of the 

requirements for reporting those CQMs 

(75 FR 44411 through 44422). 

We did not receive any public 

comments on our proposals, and we are 

finalizing the CQMs for FY 2013 as 

proposed. 

(c) CQMs for Eligible Hospitals and 

CAHs Beginning With FY 2014 

(i) Reporting Options 

We proposed to require eligible 

hospitals and CAHs to report 24 CQMs 

from a menu of 49 CQMs beginning 

with FY 2014, including at least 1 CQM 

from each of the following 6 domains, 

which are discussed in section II.B.3. of 

this final rule: 

• Patient and Family Engagement. 

• Patient Safety. 

• Care Coordination. 

• Population and Public Health. 

• Efficient Use of Healthcare 

Resources. 

• Clinical Process/Effectiveness. 

For the remaining CQMs, we proposed 

that eligible hospitals and CAHs would 

select and report CQMs that best apply 

to their patient mix. We solicited 

comments on the number of CQMs and 

the appropriateness of the CQMs and 

domains for eligible hospitals and 

CAHs. 

Comment: A few commenters stated 

that the requirement to report 24 CQMs 

was too difficult and adds to the 

administrative burden placed on eligible 

hospitals and CAHs, especially rural 

hospitals. Many commenters suggested 

that CQM reporting requirement 

beginning with 2014 remain at 15 CQMs 

due to the number of issues experienced 

by hospitals when implementing the 

Stage 1 CQMs, although other 

commenters stated that requiring up to 

18 CQMs would be reasonable. A few 

commenters noted that CQMs were not 

evenly distributed among the 6 

domains, making the requirement to 

report at least one CQM from each 

domain difficult for some hospitals. One 

commenter recommended that if a 

domain did not have at least 4 CQMs 

eligible hospitals and CAHs should not 

be required to report that domain. 

Multiple commenters stated that eligible 

hospitals and CAHs in Stage 1 in FY 

2014 may have difficulty meeting the 

CQM requirement beginning in 2014 

and recommend that the Stage 1 CQMs 

meet the requirements for those 

hospitals. Alternatively, the commenters 

recommended that if the CQMs 

beginning in 2014 are required, that the 

number of CQMs being reported be 

reduced for the eligible hospitals and 

CAHs in Stage 1 beginning in FY 2014. 

One commenter stated that CQM 

requirements failed to align with other 

meaningful use objectives. 

Response: We acknowledge that 

increasing the number of CQMs 

required to be reported from 15 in 2011, 

2012, and 2013 to 24 beginning in 2014 

increases implementation burden on 

hospitals. We have stated our intention 

to implement EHR-based reporting of 

CQMs in other quality reporting 

programs, such as the Hospital IQR 

Program. One purpose of our proposal 

to increase the number of CQMs 

reported electronically for the EHR 

Incentive Program is to create an 

electronic reporting infrastructure that 

we can also use for other quality 

reporting programs. We also 

acknowledge that the requirement of 

reporting 24 CQMs for hospitals in their 

first year of Stage 1 in 2014 is a 

significant increase from the reporting 

requirement for hospitals that entered 

Stage 1 before 2014. We also 

acknowledge the difficulty in meeting 

the requirement to report at least 1 CQM 

in each of the 6 domains. For these 

reasons, we have finalized a policy that 

decreases the number of CQMs required 

from the proposal and decreases the 

total number of domains required to be 

covered among the selected CQMs. 

After consideration of the public 

comments received and for the reasons 

discussed previously, we are finalizing 

the following policy on reporting 

requirements for CQMs for eligible 

hospitals and CAHs beginning in 2014: 

Eligible hospitals and CAHs must 

report a total of 16 CQMs covering at 

least 3 domains from Table 8. We expect 

eligible hospitals and CAHs will select 

measures that best apply to their patient 

mix. As we proposed, if an eligible 

hospital’s or CAH’s CEHRT does not 

contain patient data for at least 16 

CQMs covering at least 3 domains, then 

the eligible hospital or CAH must report 

the CQMs for which there is patient data 

and report the remaining required 

CQMs as ‘‘zero denominators’’ as 

displayed by their certified EHR 

technology. In the unlikely event that 

there are no CQMs applicable to the 

eligible hospital’s or CAH’s patient mix, 

eligible hospitals or CAHs must still 

report 16 CQMs even if zero is the result 

in either the numerator or the 

denominator of the measure. If all CQMs 

have a value of zero from their CEHRT, 

then eligible hospitals or CAHs must 

select any 16 CQMs from Table 8 to 

report. We stated in the proposed rule 

that our experience from Stage 1 in 

implementing the current set of 15 

CQMs in specialty and low volume 

eligible hospitals illuminated several 

challenges. For example, children’s 

hospitals rarely see patients 18 years or 

older. One of the exceptions to this 

generality is individuals with sickle cell 

disease. National Institutes of Health 

Guidelines (NIH Publication 02–2117) 

list the conditions under which 

thrombolytic therapy cannot be 

recommended for adults or children 

with sickle cell disease. This, plus the 

mstockstill on DSK4VPTVN1PROD with RULES2

54080 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

fact that children’s hospitals have on 

average two or fewer cases of stroke per 

year, have created workflow, cost, and 

clinical barriers to demonstrating 

meaningful use as it relates to the CQMs 

for stroke and VTE. 

We proposed to consider whether a 

case number threshold would be 

appropriate, given the apparent burden 

on hospitals that very seldom have the 

types of cases addressed by certain 

CQMs such that hospitals that do not 

have enough cases to exceed the 

threshold would be exempt from 

reporting those CQMs. We solicited 

comments on what the numerical range 

of threshold should be, how hospitals 

would demonstrate to CMS or state 

Medicaid agencies that they have not 

exceeded this threshold, whether it 

should apply to only certain hospital 

CQMs (and if so, which ones), and the 

extent of the burden on hospitals if a 

case number threshold is not adopted 

given that they are allowed to report 

‘‘zeroes’’ for the measures. We solicited 

comments on limiting the case 

threshold exemption to only children’s, 

cancer hospitals, and a subset of 

hospitals in the Indian Health System as 

they have a much narrower patient base 

than acute care and critical access 

hospitals. We requested comments on 

whether such thresholds should be 

established for 2013, noting that the 

issue could be mitigated beginning in 

2014 by our proposal to establish a 

larger menu set of CQMs from which 

hospitals would select. 

Comment: Many commenters noted 

that the implementation of a case 

number threshold for CQM reporting 

would help reduce the burden placed 

on hospitals that very seldom have cases 

in the denominator of certain CQMs. 

However, commenters suggested 

differing mechanisms by which to 

implement a case number threshold. 

Many commenters suggested that we 

use Medicare claims data from the year 

prior to a hospital’s CQM submission or 

another historical data source to 

determine whether a hospital should be 

exempt from reporting certain CQMs. 

Another commenter suggested that the 

simplest option would be to continue to 

allow hospitals to report zeroes in the 

denominators for CQMs. A few 

commenters requested that we 

implement a case number threshold for 

all hospital types, not just specialty 

hospitals or CAHs, since some acute 

care hospitals do not provide a full 

range of services. Another commenter 

suggested that we work with children’s 

hospitals and CAHs and other types of 

hospitals with unique patient 

populations to ensure that meaningful 

use requirements are feasible for them. 

Some commenters stated that low 

volume eligible hospitals and CAHs 

would not know at the beginning of a 

reporting period which CQMs would 

not meet a case number threshold and 

therefore should not have to select the 

CQMs in advance based on this 

criterion. This commenter suggested 

that the hospitals select the CQMs to 

report that are most appropriate for their 

patient populations. One commenter 

requested that a case number threshold 

be implemented for all CQM reporting 

for FY 2013. 

In terms of a specific case number 

threshold, one commenter suggested 

five or fewer cases per month as an 

appropriate threshold number to exempt 

any type of hospital from reporting a 

CQM. This same commenter also 

suggested that if a hospital does not 

have a least one CQM in a domain with 

a denominator greater than five, then 

that hospital should be exempt from 

reporting on that entire domain. 

Another commenter suggested 

exempting eligible hospitals and CAHs 

from reporting a CQM if the relevant 

patient population comprised less than 

10 percent of their discharges. Other 

commenters suggested that children’s 

hospitals be excluded from all CQMs 

that are only applicable to patients 18 

years of age or older. Another 

commenter recommended that we set a 

case number threshold of 30 cases and 

require hospitals to validate this 

exemption through attestation. Other 

commenters did not suggest a specific 

case number threshold, but requested 

that we empirically derive this value 

and that it be aligned with values across 

quality reporting programs. 

Response: We recognize the potential 

cost and work flow challenges when 

hospitals have a low volume of cases 

per year that apply to a particular CQM. 

We note that under the Hospital IQR 

Program, we do not require a hospital 

that has 5 or fewer inpatient discharges 

(Medicare and non-Medicare combined) 

in a topic area during a quarter in which 

data must be submitted to submit 

patient-level data for that topic area for 

the quarter (76 FR 51641). For the 

Hospital IQR Program, the hospital is 

still required to submit its aggregate 

population and sample size counts for 

Medicare and non-Medicare discharges 

for the topic areas each quarter, and 

hospitals that qualify for this exception 

for a particular topic can still elect to 

voluntarily submit their patient-level 

data. In order to align with the Hospital 

IQR Program, we will adopt a similar 

policy for all eligible hospitals and 

CAHs participating in the EHR Incentive 

Program, whereby hospitals with 5 or 

fewer inpatient discharges per quarter or 

20 or fewer inpatient discharges per 

year (Medicare and non-Medicare 

combined) as defined by a CQM’s 

denominator population would be 

exempted from reporting on that CQM. 

After consideration of the public 

comments received and for the reasons 

discussed earlier, we are finalizing the 

following policy on case threshold 

exemptions for eligible hospitals and 

CAHs in all stages of meaningful use 

beginning in FY 2014. However, eligible 

hospitals and CAHs that are 

demonstrating meaningful use for the 

first time must submit their CQMs 

through attestation and will not be able 

to qualify for this exemption. The 

burden of submitting the aggregate 

population and sample size counts in 

order to qualify for the exemption 

would be at least equal to the effort 

required to obtain and attest to the 

calculated CQM data. 

Eligible hospitals and CAHs that have 

5 or fewer discharges per quarter in the 

same quarter as their reporting period in 

FY 2014, or 20 or fewer discharges per 

full FY reporting period beginning in FY 

2015, for which data is being 

electronically submitted (Medicare and 

non-Medicare combined) as defined by 

the CQM’s denominator population are 

exempted from reporting the CQM. For 

example, if the CQM’s denominator 

population is ischemic stroke patients 

greater than or equal to 18 years of age, 

then the threshold would be 5 or fewer 

ischemic stroke patients aged 18 years 

or older discharged from the hospital in 

the quarter for which data is being 

submitted (the hospital’s FY 2014 3- 

month quarter reporting period). To be 

eligible for the exemption, hospitals 

must submit their aggregate population 

and sample size counts for Medicare 

and non-Medicare discharges for the 

CQM for the reporting period no later 

than the 2-month submission period of 

October 1 through November 30 

immediately following the reporting 

period (please see section II.B.1. of this 

final rule for a description of reporting 

and submission periods). Hospitals will 

report this information in the same 

manner as for the Hospital IQR Program 

(76 FR 51639 through 51641). Please 

refer to the QualityNet Web site 

(www.qualitynet.org) and the CMS/Joint 

Commission Specifications Manual for 

National Hospital Inpatient Quality 

Measures, located on the QualityNet 

Web site, for technical information 

about data submission requirements. 

Hospitals that do not seek an exemption 

under the EHR Incentive Program do not 

have to submit aggregate population and 

sample size counts for any CQMs for the 

purposes of the EHR Incentive Program. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54081 

(ii) Clinical Quality Measures 

We proposed CQMs in Table 9 of the 

Stage 2 proposed rule (77 FR 13760 to 

13763) that would apply for all eligible 

hospitals and CAHs beginning with FY 

2014, regardless of whether an eligible 

hospital or CAH is in Stage 1 or Stage 

2 of meaningful use. The set of 49 CQMs 

that we proposed included the current 

set of 15 CQMs that were finalized for 

FYs 2011 and 2012 in the Stage 1 final 

rule. 

The CQM titles and descriptions in 

Table 8 reflect the most current updates, 

as provided by the measure stewards 

who are responsible for maintaining and 

updating the measure specifications, 

and therefore may not reflect the title 

and/or description as presented on the 

NQF Web site. 

Comment: Many commenters 

requested that we finalize fewer than 49 

CQMs. The most common reasons given 

for reducing the complete list of CQMs 

included limitations of the vendors to 

program and deploy systems and for 

hospitals to effectively implement those 

systems, especially among resourcelimited organizations. 

Several commenters recommended 

that CQMs that are suspended from the 

Hospital IQR program, not NQF 

endorsed, only apply to certain regions 

of the country or not electronically 

specified should not be considered for 

CQM reporting beginning in 2014. 

Additionally, some commenters 

suggested that no new CQMs be added 

until CEHRT can produce accurate 

calculations of the existing CQMs. A 

few commenters stated that increasing 

the number of CQMs in such a narrow 

timeframe would be challenging for 

organizations in terms of designing, 

creating, and implementing new 

workflows, building, testing and 

modifying configurations to ensure 

proper discrete data capture, and 

training staff. One of these commenters 

requested a phased-in approach for 

calculating CQMs through EHRs and 

requested that we do not add any new 

manually abstracted CQMs in other 

CMS quality reporting programs. 

One commenter stated that it was 

unclear if mid-cycle modifications of 

measures would require hospitals to 

resubmit data and recommended that if 

a measure were modified or deleted 

mid-cycle that hospitals not have to 

modify measures selected. 

Response: Some of the CQMs that 

were proposed but not finalized were 

not submitted by the measure stewards 

for continued NQF endorsement (NQF 

0136 Heart Failure (HF)-1 Detailed 

Discharge Instructions, NQF 0481 First 

Temperature Measured within One 

Hour of Admission to the NICU, and 

NQF 0482 First NICU Temperature <36 

degrees C). We are not finalizing NQF 

0143 and NQF 0144, both related to 

pediatric asthma, for CQM reporting 

beginning in 2014 because hospital 

performance on these measures in the 

IQR program is at or near 100 percent. 

While pediatric asthma is a priority for 

CMS, we recognize that there are greater 

opportunities to improve care than in 

measuring the provision of relievers and 

systemic corticosteroids, which are now 

common practice. Our future quality 

measurement and improvement efforts 

will focus on other aspects of the 

clinical care for children with asthma, 

targeting for inclusion in CQM reporting 

with Stage 3 rulemaking. We have also 

taken into consideration the ability of 

the eligible hospitals and CAHs to 

report CQMs from CEHRT when 

selecting the set of CQMs for reporting 

beginning in 2014. 

CQM specifications will be updated 

on an annual basis. We will not require 

resubmission of data as a result of these 

updates. If we remove a CQM from the 

program, we would not require data to 

be submitted on any additional CQMs 

nor would this affect data submitted 

prior to removal of the CQM. See 

section II.B.4. of this final rule for 

additional details on this policy. 

Comment: Some commenters 

requested denominator definitions such 

as elective delivery vs. delivery based 

on a physician’s order, and clarification 

on age ranges. A few commenters 

requested that some of the measure 

stewards listed in Table 9 of the 

proposed rule be corrected. 

Response: Clarifications on 

denominator definitions will be 

provided in the electronic specifications 

that will be posted on or about the 

publication of the final rule. Any further 

clarification needed should be 

addressed to the measure steward. The 

measure stewards listed incorrectly in 

Table 9 of the proposed rule were 

corrected (the correction notice can be 

found at 77 FR 23195 through 23196). 

Comment/Response: Table 9 

summarizes the public comments 

received on specific proposed eligible 

hospital and CAH CQMs and the CMS 

rationale (that is, our response to the 

CQM-specific comment(s)) for finalizing 

or not finalizing the CQM for reporting 

beginning with FY 2014. 

TABLE 9—SUMMARY OF ELIGIBLE HOSPITAL AND CAH CQM-SPECIFIC COMMENTS AND RATIONALE TO FINALIZE OR NOT

FINALIZE THE CQM 

CQM No. Commenters support 

finalization 

Commenters do not support 

finalization Finalized CMS rationale 

ED Throughput: NQF 0495, 

0497, 0496.

Many supported continuing 

with Stage 1 CQMs, instead 

of requiring additional CQMs 

for Stage 2 (ED-1&2). ED 

throughput measures are required by the Joint Commission.

Few stated factors affecting 

results are outside control of 

ED, difficult to implement 

without workflow changes 

and CPOE implemented 

hospital-wide, & may reflect 

negatively on hospitals routinely receiving complex patients. One commenter 

noted may not correlate with 

improved outcomes.

Yes .......... Continues with Stage 1 CQM 

reporting for ED-1&2, aligns 

with IQR/OQR/HVBP, retooled measures passed reliability, validity, & feasibility 

testing. 

Stroke-2,3,4,5,6,8: NQF 0435, 

0436, 0437, 0438, 0439, 

0440.

Many supported continuing 

with Stage 1 CQMs, instead 

of requiring additional CQMs 

for Stage 2.

Few stated that it is difficult to 

capture certain data elements within current clinical 

workflows, and recommends 

delay to Stage 3 after further e-specification testing is 

completed.

Yes .......... Continues with Stage 1 CQM 

reporting, aligns with IQR/ 

HVBP, retooled measures 

passed reliability, validity, & 

feasibility testing. 

mstockstill on DSK4VPTVN1PROD with RULES2

54082 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 9—SUMMARY OF ELIGIBLE HOSPITAL AND CAH CQM-SPECIFIC COMMENTS AND RATIONALE TO FINALIZE OR NOT

FINALIZE THE CQM—Continued 

CQM No. Commenters support 

finalization 

Commenters do not support 

finalization Finalized CMS rationale 

Stroke-10: NQF 0441 ............... Many supported continuing 

with Stage 1 CQMs, instead 

of requiring additional CQMs 

for Stage 2.

A commenter stated that this 

is a poor care coordination 

measure but provided no 

reasons.

Yes .......... Continues with Stage 1 CQM 

reporting, aligns with IQR/ 

HVBP, retooled measures 

passed reliability, validity, & 

feasibility testing. 

VTE-1,2,3,4,5,6: NQF 371, 

0372, 0373, 0374, 0375, 

0376.

Many supported continuing 

with Stage 1 CQMs, instead 

of requiring additional CQMs 

for Stage 2.

Few stated that it is difficult to 

capture certain data elements within current clinical 

workflows, one recommended delay to Stage 3 

after further e-specification 

testing is completed.

Yes .......... Continues with Stage 1 CQM 

reporting, aligns with IQR/ 

HVBP, retooled measures 

passed reliability, validity, & 

feasibility testing. 

AMI-1, 3, 5: NQF 0132, 0137, 

0160.

One commenter supported 

AMI-3, but for Stage 3 once 

CPOE is more widely implemented & e-specifications 

can be published in a timely 

manner to allow for inclusion 

of new guidelines. Inclusion 

will help tracking compliance.

Many stated these measures 

should not be finalized since 

they have been suspended 

from IQR, are not recommended by the MAP, are 

difficult to implement without 

CPOE implemented hospital-wide & one commenter 

stated it is difficult to capture 

unless an eMAR is implemented. AMI-1 & 5 are not 

included in CMS programs.

No ............ Suspended from IQR, thus not 

supportive of program alignment. 

AMI-2, 7a: NQF 0142, 0164 .... A few commenters support including these measures for 

Stage 3 to allow for additional time for testing & implementation. AMI-2 is required by the Joint Commission. Inclusion will help 

tracking compliance.

One commenter requested 

delay to Stage 3 until CPOE 

is more widely implemented. 

One commenter noted 

AMI-2 is topped out.

Yes .......... Aligns with IQR/HVBP, which 

both consider it an important 

CQM on post-discharge AMI 

prevention for hospitals to 

report. Retooled measure 

passed reliability, validity, & 

feasibility testing. 

AMI-8a,10: NQF 0163, 0639 .... N/A .......................................... One commenter stated it is difficult to capture certain data 

elements within current clinical workflows; one commenter stated it is difficult to 

capture if CPOE is not widely implemented.

Yes .......... Aligns with IQR/HVBP, retooled measure passed reliability, validity, & feasibility 

testing. 

PN-3b: NQF 0148 .................... One commenter supports including this measure for 

Stage 3 to allow additional 

time for testing & implementation. A few commenters 

support this measure if 

e-specifications are available in a timely manner. 

This is required by the Joint 

Commission.

Delay to Stage 3 after further 

e-specification testing is 

completed.

No ............ Retired from NQF endorsement. 

PN-6: NQF 0147 N/A .......................................... One commenter states data 

collection is difficult due to 

absent decision support algorithm.

Yes .......... Aligns with IQR/HVBP, retooled measure passed reliability, validity, & feasibility 

testing. 

Elective Delivery Prior to 39 

Weeks: NQF 0469.

A commenter supports the inclusion of this safety-related 

CQM.

Not required in IQR, a commenter was concerned that 

labor and delivery applications are not part of certification.

Yes .......... Aligns with IQR, Medicaid 

Adult Core, & Strong Start 

programs, retooled measure 

passed reliability, validity, & 

feasibility testing. 

Exclusive Breast Feeding at 

Discharge: NQF 0480.

Many commenters support 

this, noting that it will help 

improve maternity care practices and create an awareness of quality of care 

issues. A commenter supported this measure, but for 

Stage 3 once labor and delivery applications are part 

of certification.

Not required in IQR, highly 

subjective measure, specific 

to California only and not 

well vetted, and contains 

data elements difficult to 

capture.

Yes .......... Aligns with Medicaid reporting 

initiatives. Measure passed 

reliability, validity, & feasibility testing. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54083 

TABLE 9—SUMMARY OF ELIGIBLE HOSPITAL AND CAH CQM-SPECIFIC COMMENTS AND RATIONALE TO FINALIZE OR NOT

FINALIZE THE CQM—Continued 

CQM No. Commenters support 

finalization 

Commenters do not support 

finalization Finalized CMS rationale 

Home Management Plan of 

Care, CAC-3: NQF 0338.

A commenter supports this 

measure, but not until documentation for peri-operative, 

intra-operative and anesthesia are parts of certification.

Not required in IQR, not supported by the MAP, and 

overly burdensome.

Yes .......... Aligns with Medicaid reporting 

initiatives. Measure passed 

reliability, validity, & feasibility testing. 

Healthy Term Newborn: NQF 

0716.

A commenter supports this 

measure. A commenter supports this measure, but for 

Stage 3 once labor and delivery applications are part 

of certification.

Not required in IQR ................. Yes .......... Aligns with Medicaid reporting 

initiatives. Measure passed 

reliability, validity, & feasibility testing. 

Hearing Screening: NQF 1354 One commenter supports this 

measure if e-specifications 

are available in a timely 

manner.

Not required in IQR ................. Yes .......... Aligns with Medicaid reporting 

initiatives. Measure passed 

reliability, validity, & feasibility testing. 

SCIP INF-1,2,9: NQF 0527, 

0528, 0453.

A commenter supports these 

measures, but not until documentation for 

peri-operative, 

intra-operative and anesthesia are parts of certification. Inclusion will help 

tracking compliance.

N/A .......................................... Yes .......... Aligns with IQR/HVBP, retooled measure passed reliability, validity, & feasibility 

testing. 

SCIP INF-3,4,6: NQF 0529, 

0300, 0301.

A commenter supports this 

measure, but not until documentation for peri-operative, 

intra-operative and anesthesia are parts of certification. SCIP-INF-3 is required by the Joint Commission..

Not required in IQR and not 

recommended by the MAP. 

One commenter noted SCIP 

INF-6 may not correlate with 

improved outcomes.

No ............ SCIP-INF-3 reflects a limited 

patient population, keeps 

the total number of Stage 2 

measure options reasonable. SCIP-INF-4 is being 

reworked by the steward. 

SCIP-INF-6 is suspended 

from reporting in IQR. 

HF-1: NQF 0136 ...................... One commenter supported ..... One commenter did not support since being retired from 

NQF endorsement.

No ............ Retired from NQF endorsement. 

First Temperature within 1 hour 

in NICU > 36° and <36°: 

NQF 0481, 0482.

One commenter supported if 

e-specifications are published in a timely manner.

A few commenters stated it is 

not required in IQR and not 

recommended by MAP.

No ............ Retired from NQF endorsement. 

Global Immunizations Pneumonia & Influenza; NQF 

1653, 1659.

N/A .......................................... A few commenters stated 

these are not consistent with 

current guidelines.

No ............ Required in IQR but not for 

HVBP, and keeps the total 

number of Stage 2 measure 

options reasonable. 

Proportion of Infants 22-29 

weeks old treated with Surfactant: NQF 0484.

N/A .......................................... Contains data elements difficult to capture.No ............ Retired from NQF endorsement. 

#All hospital CQMs finalized in this rule are NQF-endorsed. NQF endorsement includes a consensus development process that takes into account clinical guidelines and scientific evidence. NQF describes its consensus development process at http://www.qualityforum.org/Measuring_Performance/Consensus_Development_Process.aspx. 

After consideration of the public 

comments received and the measure 

selection criteria discussed, we are 

finalizing the list of 29 CQMs for 

eligible hospitals and CAHs included in 

Table 10. 

TABLE 10—CQMS FINALIZED FOR ELIGIBLE HOSPITALS AND CAHS BEGINNING WITH FY 2014 

NQF No. Title Measure steward and 

contact information 

Other quality 

measure 

programs that 

use the same 

CQM *** 

New 

CQM Domain 

0495 ..... Title: Emergency Department (ED)-1 Emergency 

Department Throughput—Median time from ED 

arrival to ED departure for admitted ED patients.

Description: Median time from emergency department arrival to time of departure from the 

emergency room for patients admitted to the 

facility from the emergency department. 

CMS/Oklahoma Foundation for Medical Quality (OFMQ) 

Qualitynet.org and 

click on ‘‘Questions & 

Answers’’.

IQR ................... ............. Patient and Family Engagement. 

mstockstill on DSK4VPTVN1PROD with RULES2

54084 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 10—CQMS FINALIZED FOR ELIGIBLE HOSPITALS AND CAHS BEGINNING WITH FY 2014—Continued 

NQF No. Title Measure steward and 

contact information 

Other quality 

measure 

programs that 

use the same 

CQM *** 

New 

CQM Domain 

0497 ..... Title: ED-2 Emergency Department Throughput— 

admitted patients—Admit decision time to ED 

departure time for admitted patients.

Description: Median time (in minutes) from admit 

decision time to time of departure from the 

emergency department for emergency department patients admitted to inpatient status. 

CMS/OFMQ 

Qualitynet.org and 

click on ‘‘Questions & 

Answers’’.

IQR ................... ............. Patient and Family Engagement. 

0435 ..... Title: Stroke-2 Ischemic stroke—Discharged on 

anti-thrombotic therapy.

Description: Ischemic stroke patients prescribed 

antithrombotic therapy at hospital discharge. 

The Joint Commission 

www.jointcommission.

org and click on 

‘‘Contact Us’’.

IQR ................... ............. Clinical Process/Effectiveness. 

0436 ..... Title: Stroke-3 Ischemic stroke—Anticoagulation 

Therapy for Atrial Fibrillation/Flutter.

Description: Ischemic stroke patients with atrial fibrillation/flutter who are prescribed 

anticoagulation therapy at hospital discharge. 

The Joint Commission 

www.jointcommission.

org and click on 

‘‘Contact Us’’.

IQR ................... ............. Clinical Process/Effectiveness. 

0437 ..... Title: Stroke-4 Ischemic stroke—Thrombolytic 

Therapy.

Description: Acute ischemic stroke patients who 

arrive at this hospital within 2 hours (120 minutes) of time last known well and for whom IV 

t-PA was initiated at this hospital within 3 hours 

(180 minutes) of time last known well. 

The Joint Commission 

www.jointcommission.

org and click on 

‘‘Contact Us’’.

IQR ................... ............. Clinical Process/Effectiveness. 

0438 ..... Title: Stroke-5 Ischemic stroke—Antithrombotic 

therapy by end of hospital day two.

Description: Ischemic stroke patients administered antithrombotic therapy by the end of hospital day two. 

The Joint Commission 

www.jointcommission.

org and click on 

‘‘Contact Us’’.

IQR ................... ............. Clinical Process/Effectiveness. 

0439 ..... Title: Stroke-6 Ischemic stroke—Discharged on 

Statin Medication.

Description: Ischemic stroke patients with LDL 

greater than or equal to 100 mg/dL, or LDL not 

measured, or, who were on a lipid-lowering 

medication prior to hospital arrival are prescribed statin medication at hospital discharge. 

The Joint Commission 

www.jointcommission.

org and click on 

‘‘Contact Us’’.

IQR ................... ............. Clinical Process/Effectiveness. 

0440 ..... Title: Stroke-8 Ischemic or hemorrhagic stroke— 

Stroke education.

Description: Ischemic or hemorrhagic stroke patients or their caregivers who were given educational materials during the hospital stay addressing all of the following: activation of emergency medical system, need for follow-up after 

discharge, medications prescribed at discharge, risk factors for stroke, and warning 

signs and symptoms of stroke. 

The Joint Commission 

www.jointcommission.

org and click on 

‘‘Contact Us’’.

IQR ................... ............. Patient & Family Engagement. 

0441 ..... Title: Stroke-10 Ischemic or hemorrhagic stroke— 

Assessed for Rehabilitation.

Description: Ischemic or hemorrhagic stroke patients who were assessed for rehabilitation 

services. 

The Joint Commission 

www.jointcommission.

org and click on 

‘‘Contact Us’’.

IQR ................... ............. Care Coordination. 

0371 ..... Title: Venous Thromboembolism (VTE)-1 VTE 

prophylaxis.

Description: This measure assesses the number 

of patients who received VTE prophylaxis or 

have documentation why no VTE prophylaxis 

was given the day of or the day after hospital 

admission or surgery end date for surgeries 

that start the day of or the day after hospital 

admission. 

The Joint Commission 

www.jointcommission.

org and click on 

‘‘Contact Us’’.

IQR ................... ............. Patient Safety. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54085 

TABLE 10—CQMS FINALIZED FOR ELIGIBLE HOSPITALS AND CAHS BEGINNING WITH FY 2014—Continued 

NQF No. Title Measure steward and 

contact information 

Other quality 

measure 

programs that 

use the same 

CQM *** 

New 

CQM Domain 

0372 ..... Title: VTE-2 Intensive Care Unit (ICU) VTE prophylaxis.

Description: This measure assesses the number 

of patients who received VTE prophylaxis or 

have documentation why no VTE prophylaxis 

was given the day of or the day after the initial 

admission (or transfer) to the Intensive Care 

Unit (ICU) or surgery end date for surgeries 

that start the day of or the day after ICU admission (or transfer). 

The Joint Commission 

www.jointcommission.

org and click on 

‘‘Contact Us’’.

IQR ................... ............. Patient Safety. 

0373 ..... Title: VTE-3 VTE Patients with Anticoagulation 

OverlapTherapy.

Description: This measure assesses the number 

of patients diagnosed with confirmed VTE who 

received an overlap of parenteral (intravenous 

[IV] or subcutaneous [subcu]) anticoagulation 

and warfarin therapy. For patients who received less than five days of overlap therapy, 

they must be discharged on both medications 

or have a reason for discontinuation of overlap 

therapy. Overlap therapy must be administered 

for at least five days with an international normalized ratio (INR) greater than or equal to 2 

prior to discontinuation of the parenteral 

anticoagulation therapy, discharged on both 

medications or have a reason for discontinuation of overlap therapy. 

The Joint Commission 

www.jointcommission.

org and click on 

‘‘Contact Us’’.

IQR ................... New ..... Clinical Process/Effectiveness. 

0374 ..... Title: VTE-4 VTE Patients Receiving 

Unfractionated Heparin (UFH) with Dosages/ 

Platelet Count Monitoring by Protocol (or Nomogram).

Description: This measure assesses the number 

of patients diagnosed with confirmed VTE who 

received intravenous (IV) UFH therapy dosages AND had their platelet counts monitored 

using defined parameters such as a nomogram 

or protocol. 

The Joint Commission 

www.jointcommission.

org and click on 

‘‘Contact Us’’.

IQR ................... New ..... Clinical Process/Effectiveness. 

0375 ..... Title: VTE-5 VTE discharge instructions ...............

Description: This measure assesses the number 

of patients diagnosed with confirmed VTE that 

are discharged to home, home care, court/law 

enforcement, or home on hospice care on warfarin with written discharge instructions that address all four criteria: compliance issues, dietary advice, follow-up monitoring, and information about the potential for adverse drug reactions/interactions. 

The Joint Commission 

www.jointcommission.

org and click on 

‘‘Contact Us’’.

IQR ................... New ..... Patient and Family Engagement. 

0376 ..... Title: VTE-6 Incidence of potentially preventable 

VTE.

Description: This measure assesses the number 

of patients diagnosed with confirmed VTE during hospitalization (not present at admission) 

who did not receive VTE prophylaxis between 

hospital admission and the day before the VTE 

diagnostic testing order date. 

The Joint Commission 

www.jointcommission.

org and click on 

‘‘Contact Us’’.

IQR ................... New ..... Patient Safety. 

0142 ..... Title: AMI-2-Aspirin Prescribed at Discharge for 

AMI.

Description: Acute myocardial infarction (AMI) patients who are prescribed aspirin at hospital 

discharge. 

CMS/OFMQ www.

qualitynet.org and 

click on ‘‘Questions & 

Answers’’.

IQR ................... New ..... Clinical Process/Effectiveness. 

0469 ..... Title: PC-01 Elective Delivery Prior to 39 Completed Weeks Gestation.

Description: Patients with elective vaginal deliveries or elective cesarean sections at >= 37 

and <39 weeks of gestation completed. 

The Joint Commission 

(TJC) www.

jointcommission.org 

and click on ‘‘Contact 

Us’’.

TJC ................... ............. Clinical Process/Effectiveness. 

mstockstill on DSK4VPTVN1PROD with RULES2

54086 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 10—CQMS FINALIZED FOR ELIGIBLE HOSPITALS AND CAHS BEGINNING WITH FY 2014—Continued 

NQF No. Title Measure steward and 

contact information 

Other quality 

measure 

programs that 

use the same 

CQM *** 

New 

CQM Domain 

0164 ..... Title: AMI-7a—Fibrinolytic Therapy Received 

Within 30 minutes of Hospital Arrival.

Description: Acute myocardial infarction (AMI) patients with ST-segment elevation or LBBB on 

the ECG closest to arrival time receiving 

fibrinolytic therapy during the hospital stay and 

having a time from hospital arrival to 

fibrinolysis of 30 minutes or less. 

CMS/OFMQ www.

qualitynet.org and 

click on ‘‘Questions & 

Answers’’.

IQR, HVBP ....... New ..... Clinical Process/Effectiveness. 

0163 ..... Title: AMI-8a—Primary PCI Received Within 90 

Minutes of Hospital Arrival.

Description: Acute myocardial infarction (AMI) patients with ST-segment elevation or LBBB on 

the ECG closest to arrival time receiving primary PCI during the hospital stay with a time 

from hospital arrival to PCI of 90 minutes or 

less. 

CMS/OFMQ www.

qualitynet.org and 

click on ‘‘Questions & 

Answers’’.

IQR, HVBP ....... New ..... Clinical Process/Effectiveness. 

0639 ..... Title: AMI-10 Statin Prescribed at Discharge ........

Description: Acute Myocardial Infarction (AMI) 

patients who are prescribed a statin at hospital 

discharge. 

CMS/OFMQ www.

qualitynet.org and 

click on ‘‘Questions & 

Answers’’.

IQR ................... New ..... Clinical Process/Effectiveness. 

0147 ..... Title: PN-6—Initial Antibiotic Selection for Community-Acquired Pneumonia (CAP) in 

Immunocompetent Patients.

Description: Immunocompetent patients with 

Community-Acquired Pneumonia who receive 

an initial antibiotic regimen during the first 24 

hours that is consistent with current guidelines. 

CMS/OFMQ www.

qualitynet.org and 

click on ‘‘Questions & 

Answers’’.

IQR, HVBP ....... New ..... Efficient Use of 

Healthcare Resources. 

0527 ..... Title: SCIP-INF-1 Prophylactic Antibiotic Received within 1 Hour Prior to Surgical Incision.

Description: Surgical patients with prophylactic 

antibiotics initiated within one hour prior to surgical incision. Patients who received 

Vancomycin or a Fluoroquinolone for prophylactic antibiotics should have the antibiotics initiated within 2 hours prior to surgical incision. 

Due to the longer infusion time required for 

Vancomycin or a Fluoroquinolone, it is acceptable to start these antibiotics within 2 hours 

prior to incision time. 

CMS/OFMQ www.

qualitynet.org and 

click on ‘‘Questions & 

Answers’’.

IQR, HVBP ....... New ..... Patient Safety. 

0528 ..... Title: SCIP-INF-2-Prophylactic Antibiotic Selection 

for Surgical Patients.

Description: Surgical patients who received prophylactic antibiotics consistent with current 

guidelines (specific to each type of surgical 

procedure). 

CMS/OFMQ www.

qualitynet.org and 

click on ‘‘Questions & 

Answers’’.

IQR, HVBP ....... New ..... Efficient Use of 

Healthcare Resources. 

0453 ..... Title: SCIP-INF-9—Urinary catheter removed on 

Postoperative Day 1 (POD1) or Postoperative 

Day 2 (POD2) with day of surgery being day 

zero. 

Description: Surgical patients with urinary catheter removed on Postoperative Day 1 or Postoperative Day 2 with day of surgery being day 

zero. 

CMS/OFMQ www.

qualitynet.org and 

click on ‘‘Questions & 

Answers’’.

IQR, TJC .......... New ..... Patient Safety. 

0496 ..... Title: ED-3—Median time from ED arrival to ED 

departure for discharged ED patients. 

Description: Median time from emergency department arrival to time of departure from the 

emergency room for patients discharged from 

the emergency department. 

CMS/OFMQ www.

qualitynet.org and 

click on ‘‘Questions & 

Answers’’.

OQR ................. New ..... Care Coordination. 

0338 ..... Title: Home Management Plan of Care (HMPC) 

Document Given to Patient/Caregiver.

Description: An assessment that there is documentation in the medical record that a Home 

Management Plan of Care (HMPC) document 

was given to the pediatric asthma patient/caregiver. 

The Joint Commission 

(TJC) www.

jointcommission.org 

and click on ‘‘Contact 

Us’’.

state use ........... New ..... Patient & Family Engagement. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54087 

TABLE 10—CQMS FINALIZED FOR ELIGIBLE HOSPITALS AND CAHS BEGINNING WITH FY 2014—Continued 

NQF No. Title Measure steward and 

contact information 

Other quality 

measure 

programs that 

use the same 

CQM *** 

New 

CQM Domain 

0480 ..... Title: Exclusive Breast Milk Feeding .....................

Description: Exclusive breast milk feeding during 

the newborn’s entire hospitalization. 

The Joint Commission 

(TJC) www.

jointcommission.org 

and click on ‘‘Contact 

Us’’.

state use ........... New ..... Clinical Process/Effectiveness. 

0716 ..... Title: Healthy Term Newborn ................................

Description: Percent of term singleton live births 

(excluding those with diagnoses originating in 

the fetal period) who DO NOT have significant 

complications during birth or the nursery care. 

California Maternal 

Quality Care Collaborative www.cmqcc.org 

and click on ‘‘Contact 

Us’’.

state use ........... New ..... Patient Safety. 

1354 ..... Title: EHDI-1a—Hearing screening prior to hospital discharge.

Description: This measure assesses the proportion of births that have been screened for hearing loss before hospital discharge. 

CDC www.cdc.gov and 

click on ‘‘Contact 

CDC’’.

state use ........... New ..... Clinical Process/Effectiveness. 

*** IQR = Inpatient Quality Reporting. 

TJC = The Joint Commission. 

HVBP = Hospital Value-Based Purchasing. 

OQR = Outpatient Quality Reporting. 

8. Reporting Methods for Eligible 

Hospitals and Critical Access Hospitals 

(a) Reporting Methods in FY 2013 

In the Stage 2 proposed rule, we did 

not propose any reporting methods for 

Medicare eligible hospitals and CAHs in 

2013. However, in the CY 2013 OPPS 

proposed rule (77 FR 45188), we stated 

that eligible hospitals and CAHs may 

continue to report by attestation CQM 

results as calculated by CEHRT, as they 

did for 2011 and 2012. For further 

explanation of reporting CQMs by 

attestation, please see the Stage 1 final 

rule (75 FR 44430 through 44434). We 

also proposed in the CY 2013 OPPS 

proposed rule (77 FR 45188) to continue 

for 2013 the voluntary electronic 

reporting pilot for CQMs (the Medicare 

EHR Incentive Program Electronic 

Reporting Pilot for Eligible Hospitals 

and CAHs), which we had previously 

established for 2012. We expect to 

finalize in the CY 2013 Hospital OPPS 

final rule the reporting methods that 

would apply in 2013 for eligible 

hospitals and CAHs participating in the 

Medicare EHR Incentive Program. 

(b) Reporting Methods Beginning With 

FY 2014 

Under section 1886(n)(3)(A)(iii) of the 

Act, eligible hospitals and CAHs must 

submit information on the CQMs 

selected by the Secretary ‘‘in a form and 

manner specified by the Secretary’’ as 

part of demonstrating meaningful use of 

CEHRT. We proposed that Medicare 

eligible hospitals and CAHs would 

select one of the following two options 

for submitting CQMs electronically. 

• Option 1: Submit the selected 24 

CQMs through a CMS-designated portal. 

We proposed that CQM data would be 

submitted in an XML-based format on 

an aggregate basis reflective of all 

patients without regard to payer. This 

method would require eligible hospitals 

and CAHs to log into a CMS-designated 

portal and submit through an upload 

process data that is based on specified 

structures produced as output from their 

CEHRT. 

• Option 2: Submit the selected 24 

CQMs in a manner similar to the 2012 

Medicare EHR Incentive Program 

Electronic Reporting Pilot for Eligible 

Hospitals and CAHs using CEHRT. 

We proposed that, as an alternative to 

the aggregate-level reporting schema 

described previously under Option 1, 

Medicare eligible hospitals and CAHs 

that successfully report CQMs through 

an electronic reporting method similar 

to the 2012 Medicare EHR Incentive 

Program Electronic Reporting Pilot for 

Eligible Hospitals and CAHs using 

CEHRT would satisfy their CQMs 

reporting requirement under the 

Medicare EHR Incentive Program. 

Please refer to the CY 2012 OPPS final 

rule (76 FR 74489 through 74492) for 

details on the pilot. 

We noted that the Hospital IQR 

program does not currently have an 

electronic reporting mechanism. We 

solicited comments on whether an 

electronic reporting option is 

appropriate for the Hospital IQR 

Program and whether it would provide 

further alignment with the EHR 

Incentive Program. 

Comment: One commenter preferred 

Option 1 because it seems less 

burdensome. This commenter believed 

that a third party data warehouse to 

store patient-level data and aggregate 

the results would be necessary prior to 

implementing Option 1. The commenter 

also believed that the hospital should be 

able to calculate its own results. 

Response: Hospitals have access to 

patient-level data. A hospital could use 

a CEHRT that can calculate CQM results 

and also directly report patient-level 

data to CMS, so these functions are not 

mutually exclusive. No data warehouse 

is necessary. 

Comment: One commenter supported 

both the aggregate XML-based reporting 

option and the option similar to the 

2012 Medicare EHR Incentive Program 

Electronic Reporting Pilot as well as the 

longer-term goal of attaining full 

automatic electronic reporting. Another 

commenter urged us to make the 

strategy for automating the reporting of 

CQM data clear, so that hospitals can 

avoid reporting the same quality data 

through multiple reporting mechanisms. 

One commenter urged us to make the 

necessary investment to establish the 

infrastructure for the flow of EHR data, 

with careful consideration given to how 

we will ensure reliable, valid, and 

complete CQM data. 

Response: We are working to align the 

EHR Incentive Program with various 

other quality reporting programs in 

order to reduce duplicative reporting to 

the extent feasible and practical, 

beginning with the Hospital IQR 

Program. Under the Hospital IQR 

Program, hospitals report some 

mstockstill on DSK4VPTVN1PROD with RULES2

54088 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

measures by submitting chart-abstracted 

patient-level data, reflective of all 

patients without regard to payer. More 

information on the Hospital IQR 

Program, including the chart-abstracted 

measure data submission process, can 

be found in the ‘‘Guide to CMS Hospital 

IQR Program’’ on the QualityNet Web 

site (http://www.qualitynet.org/, select 

‘‘Hospital Inpatient Quality Reporting 

Program’’ from the ‘‘Hospitals— 

Inpatient’’ dropdown menu and click on 

the link to the guide from the 

‘‘Handbooks’’ menu on the right side of 

the page). We expect to establish a 

similar mechanism for electronic 

submission of CQM data for the EHR 

Incentive Program. 

The Hospital IQR Program does not 

currently have an EHR reporting option 

or requirement, but eligible hospitals 

and CAHs have been able to meet the 

CQM requirement for the EHR Incentive 

Program via the electronic reporting 

pilot. However, we expect that the 

Hospital IQR Program will transition to 

EHR-based reporting in a manner 

similar to the electronic reporting pilot, 

using an electronic transmission format 

such as the QRDA–I (for patient-level 

data). If the Hospital IQR Program 

establishes an EHR reporting option or 

requirement, we would consider 

whether we should allow hospitals to 

report CQMs through that mechanism 

using CEHRT for purposes of satisfying 

the CQM reporting component of the 

EHR Incentive Program. 

We proposed to consider an ‘‘interim 

submission’’ option for Medicare 

eligible hospitals and CAHs that are in 

their first year of Stage 1 beginning in 

FY 2014 through an electronic reporting 

method similar to the 2012 Medicare 

EHR Incentive Program Electronic 

Reporting Pilot for Eligible Hospitals 

and CAHs. Under this option, eligible 

hospitals and CAHs would 

electronically submit CQM data for a 

continuous 90-day EHR reporting 

period, and the data would have to be 

received no later than July 1 to meet the 

requirements of the EHR Incentive 

Program for purposes of avoiding a 

payment adjustment in the following 

year. We solicited public comment on 

this potential option. 

Comment: One commenter supported 

an ‘‘interim submission’’ option for 

those in their first year, which the 

commenter stated could also serve as a 

transitional step for those catching up. 

Response: Since we are allowing 

eligible hospitals and CAHs to submit 

their CQM data through attestation if 

they are in their first year of Stage 1, we 

are not finalizing the proposed interim 

submission option. 

After consideration of the public 

comments received, we are finalizing 

the following policy for CQM reporting 

methods for eligible hospitals and CAHs 

beginning in FY 2014. 

Eligible hospitals and CAHs that are 

in their first year of Stage 1 must report 

the selected 16 CQMs through 

attestation (please refer to the Stage 1 

final rule for an explanation of reporting 

CQMs through attestation (75 FR 44430 

through 44434)). For purposes of 

avoiding a payment adjustment, eligible 

hospitals that are in their first year of 

demonstrating meaningful use in the 

year immediately preceding a payment 

adjustment year must submit their CQM 

data no later than July 1 of such 

preceding year. We note that this 

deadline does not apply to CAHs. For 

more details on submission deadlines 

specific to CAHs, please refer to section 

II.D.4. of this final rule. 

Eligible hospitals and CAHs that are 

beyond their first year of meaningful use 

will be required to electronically submit 

the selected 16 CQMs using CEHRT 

using one of the options listed in this 

section of this final rule. Consistent 

with section 1886(n)(3)(B)(ii) of the Act, 

in the unlikely event that the Secretary 

does not have the capacity to receive 

CQM data electronically, eligible 

hospitals and CAHs may continue to 

report aggregate CQM results through 

attestation. 

• Option 1: Submit the selected 16 

CQMs on an aggregate basis through a 

CMS-designated transmission method 

using CEHRT. 

The CQM data will be submitted in 

the QRDA–III format reflective of all 

patients without regard to payer. This 

method will require transmitting the 

data via a CMS-designated transmission 

method. 

• Option 2: Submit the selected 16 

CQMs on a patient-level basis in a 

manner similar to the 2012 Medicare 

EHR Incentive Program Electronic 

Reporting Pilot for Eligible Hospitals 

and CAHs using CEHRT. As long as the 

CQM data originates from CEHRT, it 

may be submitted directly from the 

hospital’s CEHRT to CMS or through a 

data intermediary to CMS. 

The electronically reported patientlevel CQM data must use the QRDA 

category I (release 2) based on the 

Quality Data Model (QDM), which will 

include only patients that meet the 

denominator criteria of each reported 

CQM without regard to payer. For 

example, if a hospital selects NQF 

#0438 to report, the denominator 

criteria include ischemic stroke 

patients, so the QRDA–I for this CQM 

would include only ischemic stroke 

patients. This method will require 

submitting the data via a transmission 

method similar to the 2012 Medicare 

EHR Incentive Program Electronic 

Reporting Pilot for Eligible Hospitals 

and CAHs (76 FR 74122). The 

requirement that eligible hospitals and 

CAHs submit patient-level data under 

the EHR Incentive Program is consistent 

with the requirement that hospitals 

submit patient-level data under other 

quality reporting programs such as the 

Hospital IQR Program. 

We proposed to consider the 

following 4 options of patient 

population—payer data submission 

characteristics: 

• All patients—Medicare only. 

• All patients—all payer. 

• Sampling—Medicare only, or 

• Sampling—all payer. 

Currently, the Hospital IQR program 

uses the ‘‘sampling—all payer’’ data 

submission characteristic. We solicited 

public comment on each of these 4 sets 

of characteristics and the impact they 

may have to vendors and hospitals, 

including but not limited to potential 

issues with the respective size of data 

files for each characteristic. We 

proposed to select 1 of the 4 sets as the 

data submission characteristic for the 

electronic reporting method for eligible 

hospitals and CAHs beginning in FY 

2014. 

Comment: Many commenters favored 

the all patient-all payer submission 

option. Nearly all of these commenters 

supported this option because of 

challenges identifying whether a patient 

is covered by Medicare or not. One 

commenter also noted that sampling 

Medicare patients alone would severely 

decrease the population of patients 

reported in the denominator for many 

CQMs, and that it is difficult to validate 

that the sampling is being done 

correctly. The commenter also argued 

that since data is captured at the time 

of care, there should be no difficulty 

submitting the data and therefore no 

need for sampling. Another commenter 

advised against permitting sampling for 

CQM reporting beginning in 2014 as it 

adds an additional level of complexity. 

One commenter stated that the ideal 

solution would be having both—all 

patient-all payer, and all patientMedicare only, which would allow for 

Medicare vs. non-Medicare 

comparisons. 

Some commenters who favored the all 

patient-all payer data submission option 

suggested that sampling-all payer be 

made available as an alternative option, 

with one noting that a no-sampling 

method may be burdensome for hospital 

staff who must manually enter clinical 

data that is not captured electronically. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54089 

If sampling is adopted, the commenter 

asks that it align with existing Hospital 

IQR Program sampling methodologies. 

One commenter preferred the samplingall payer submission option, noting that 

it aligns with the reporting method for 

the Hospital IQR Program. 

Response: We acknowledge hospitals’ 

concerns about accurately 

distinguishing Medicare patients from 

other patients in their populations, and 

recognize that reporting data on 

Medicare patients only would reduce 

the population of patients for whom 

data are reported in most cases. Since 

payer will be collected as a 

supplemental data element for all CQMs 

beginning in 2014, we will be able to 

stratify measure results by payer. In the 

2014 Edition certification criteria, ONC 

has increased the focus on CEHRT’s 

capability to capture the structured data 

elements required for reporting the 

CQMs finalized in this rule. Therefore, 

the burden on hospital staff to manually 

enter data from a source other than the 

CEHRT should be greatly reduced. We 

also expect to propose electronic 

sampling algorithms in future 

rulemaking. 

After consideration of the public 

comments received, we are finalizing 

the ‘‘sampling-all payer’’ option for 

patient-level data. This submission 

characteristic will only include patients 

that meet the denominator criteria of the 

CQMs that the eligible hospital or CAH 

selects to report to CMS and only the 

data elements listed in the CQM and 

transmission specifications for those 

patients would be sent to CMS. 

(c) Electronic Reporting of Clinical 

Quality Measures for Medicaid Eligible 

Hospitals 

States that have launched their 

Medicaid EHR Incentive Programs plan 

to collect CQMs electronically from 

CEHRT used by eligible hospitals. Each 

state is responsible for sharing the 

details on the process for electronic 

reporting with its provider community. 

We anticipate that whatever means 

states have deployed for capturing 

CQMs included in the Stage 1 final rule 

electronically will be similar for CQMs 

beginning in 2014. However, we note 

that subject to our prior approval, the 

process, requirements, and the timeline 

is within the states’ purview. 

Comment: Commenters suggested 

unified Medicaid CQM reporting to 

reduce the burden on eligible hospitals 

operating in multiple states. 

Response: For the purposes of the 

Medicaid EHR Incentive Program, 

eligible hospitals only have to report 

CQMs to the state making the EHR 

incentive payment. However, data from 

all practice locations that are equipped 

with CEHRT will be used for reporting 

CQMs, even if the practice locations are 

in different states. 

After consideration of the public 

comments received, we are finalizing 

the policies for electronic reporting of 

CQMs for Medicaid eligible hospitals as 

proposed. We are clarifying that duallyeligible hospitals may submit their 

CQMs via the methods outlined in 

section II.B.8.b. of this final rule. As part 

of certification for EHR technology, 

ONC is including testing for data 

capture, CQM calculation, and 

electronic submission. For CQMs, this 

includes certification criteria for the 

QRDA–I and QRDA–III transmission 

format. We expect the states that have 

electronic reporting options for CQMs 

might choose to adopt QRDA–I for 

patient-level data and/or QRDA–III for 

aggregate data as the form in which 

eligible hospitals would report CQM 

data. By adopting the same QRDA–I 

and/or QRDA–III formats that CMS is 

requiring for CQM reporting, the states 

would be able to leverage the 

development of the specifications by 

CMS and the industry as well as the 

testing done by ONC for certification of 

EHR technology. This would reduce the 

burden on EHR vendors to implement 

and test different specifications. 

C. Demonstration of Meaningful Use 

and Other Issues 

1. Demonstration of Meaningful Use 

a. Common Methods of Demonstration 

in Medicare and Medicaid 

We proposed to continue our common 

method for demonstrating meaningful 

use in both the Medicare and Medicaid 

EHR Incentive Programs. The 

demonstration methods we adopt for 

Medicare will automatically be available 

to the states for use in their Medicaid 

programs. The Medicare methods are 

segmented into CQMs and meaningful 

use objectives, both of which 

meaningful users must meet. (We note 

that the discussion in this part of the 

preamble discuss the methods for 

meaningful use objectives. For the 

discussion on CQM reporting, please 

refer to II.B. of this final rule). We did 

not receive any comments on this 

general policy and for this final rule will 

continue the policy that was proposed 

(that is, common methods of 

demonstration with some flexibility for 

states as described in II.A.3.c of this 

final rule). 

b. Methods for Demonstration of the 

Stage 2 Criteria of Meaningful Use 

Except for the batch reporting option 

discussed in section II.C.1.c. of this final 

rule, we proposed no other changes to 

the attestation process for Stage 2 

meaningful use objectives. We proposed 

several changes to reporting for CQMs 

beginning 2014, regardless of Stage, as 

discussed in section II.B. of this final 

rule. An EP, eligible hospital or CAH 

must successfully attest to the Stage 2 

meaningful use objectives and 

successfully submit clinical quality 

measures to be a meaningful EHR user. 

We have revised § 495.8 to 

accommodate the Stage 2 objectives and 

measures, as well as changes to Stage 1. 

As discussed in our proposed rule (77 

FR 13764), as HIT matures we expect to 

base demonstration more on automated 

reporting by CEHRT, such as the direct 

electronic reporting of measures, both 

clinical and nonclinical, and 

documented participation in HIE. As 

this occurs, fewer objectives will be 

demonstrated through attestation. As 

explained in the proposed rule, 

however, we do not believe that the 

current advances in HIT and the 

certification of EHR technologies allow 

an alternative to attestation for the Stage 

2 final rule. We will continue to 

evaluate possible alternatives to 

attestation and the accompanying 

changes to certification and meaningful 

use. 

In addition, in lieu of EP-by-EP 

attestation, we proposed a batch file 

process for attestation. This batch file 

process would continue to require that 

meaningful use measures be assessed at 

the individual EP, eligible hospital or 

CAH level. It would be available no later 

than January 1, 2014. Batch reporting 

would allow large group practices to 

submit a large number of attestations at 

once, while still maintaining individual 

assessments of meaningful use. We 

proposed that a batch file process as 

discussed later would occur through the 

CMS attestation Web site. Each EP 

would still meet the required 

meaningful use thresholds 

independently; our proposal did not 

allow the use of group averages or any 

other method of group demonstration. 

We explained that CMS and the states 

could continue to test options, such as 

registries or the direct electronic 

reporting of some measures; however, 

any such testing would be voluntary. 

c. Group Reporting Option of 

Meaningful Use Core and Menu 

Objectives and Associated Measures for 

Medicare and Medicaid EPs Beginning 

With CY 2014 

As explained previously, we proposed 

a batch reporting process that would 

allow groups of EPs to report each 

individual EP’s core and menu objective 

data through a batch process, but would 

mstockstill on DSK4VPTVN1PROD with RULES2

54090 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

maintain individual assessments of 

meaningful use. (We note that the 

discussion in this part of the preamble 

does not discuss CQM reporting, which 

is discussed in II.B. of this final rule). 

Specifically, we proposed to establish 

a file format in which groups could 

submit core and menu objective 

information for individual Medicare EPs 

(including the stage of meaningful use 

the individual EP is in, numerator, 

denominator, exclusion, and yes/no 

information for each core and menu 

objective) as well as a process for 

uploading such batch files. 

We proposed that states would have 

the option, but not be required to, offer 

batch reporting of meaningful use data 

for Medicaid EP, and that states would 

outline their approaches in their state 

Medicaid HIT Plans (under current 

regulatory requirements in 

§ 495.332(c)(2) and (c)(3)). 

We proposed the following policies 

would apply to batch reporting: 

• Define a Medicare EHR Incentive 

Group as 2 or more EPs, each identified 

with a unique NPI associated with a 

group practice identified under one tax 

identification number (TIN) through the 

Provider Enrollment, Chain, and 

Ownership System (PECOS). 

• States choosing to exercise this 

option will have to clearly define a 

Medicaid EHR Incentive Group via their 

state Medicaid HIT Plan. 

• None of the EPs in either a 

Medicare or Medicaid EHR Incentive 

Group could be hospital-based 

according to the definition for these 

programs (see 42 CFR 495.4). 

• Any EP that successfully attests as 

part of one Medicare EHR Incentive 

Group will not be permitted to also 

attest individually or attest as part of a 

batch report for another Medicare EHR 

Incentive Group. 

• Because EPs can only participate in 

either the Medicare or Medicaid 

incentive programs in the same payment 

year, an EP that is part of a Medicare 

EHR Incentive Group will not be able to 

receive a Medicaid EHR incentive 

payment or be included as part of a 

batch report for a Medicaid EHR 

Incentive Group or vice versa. 

• The group reporting option 

discussed in this section is limited to 

data for the core and menu objectives 

and does not include the reporting of 

clinical quality measures, which is also 

required to demonstrate meaningful use 

and receive an EHR incentive payment. 

Clinical quality measures must be 

reported separately through other 

electronic submission options. (These 

options are described in section II.B. of 

this final rule.). 

• Because we proposed multiple 

group reporting methods for clinical 

quality measures, EPs will not have to 

report core and menu objective data in 

the same EHR Incentive Group as they 

report clinical quality measures. An EP 

will be able to submit the core and 

menu objectives as part of a group and 

the clinical quality measures as an 

individual or submit the core and menu 

objectives as an individual and the 

clinical quality measures as part of a 

group. 

• Batch reporting would not be 

required by CMS and t EPs will be 

permitted to attest individually through 

the CMS attestation Web site (as long as 

they did not also report as part of a 

group). 

• As in Stage 1, EPs will be required 

to individually meet all of the 

thresholds of the core and menu 

objectives and could not use group 

averages or any other method of group 

demonstration. 

• Batch reporting would not change 

the policy that payment adjustments 

will be applied to individual EPs and 

not to Medicare EHR Incentive Groups. 

This policy is described in section II.D. 

of this final rule. 

• Batch reporting would not change 

incentive payment assignment. That is, 

as with Stage 1, an EP’s incentive 

payment will not be automatically 

assigned to the Medicare EHR Incentive 

Group with which they batch report 

under this option. The EP will still have 

to select the payee TIN during the 

registration process. 

• An EP who chooses the group 

reporting option will be required to 

include in such reporting core and 

menu objective information on all 

outpatient encounters (that is, all 

encounters except those in the inpatient 

and emergency departments) where 

CEHRT is available, even if some 

encounters occurred at locations not 

associated with the EP’s Medicare EHR 

Incentive Group. We explained that this 

policy is required because EPs who 

practice in multiple practices or 

locations are responsible for submitting 

complete information for all actions 

taken at practices/locations equipped 

with CEHRT. Under § 495.4, to be 

considered a meaningful EHR user, an 

EP must have 50 percent or more of 

their outpatient encounters in 

practice(s) or location(s) where CEHRT 

is available. In the July 28, 2010 final 

rule (75 FR 44329), we also made clear 

that an EP must include outpatient 

encounters for all locations equipped 

with CEHRT. 

• There would not be a minimum 

participation threshold for reporting as 

part of an EHR Incentive Group; in other 

words, an EP who is able to meet the 50 

percent threshold of patient encounters 

in locations equipped with CEHRT 

could report all of their core and menu 

objective data as part of an EHR 

Incentive Group in which they had only 

5 percent of their patient encounters 

with that group, provided they report all 

of the data from the other locations 

through the same batch reporting 

process with the EHR Incentive Group. 

Many commenters supported our 

proposal to institute a batch reporting 

process. 

Some commenters offered comments 

or requested clarification. The summary 

of the comments and our responses 

follow: 

Comment: A few commenters 

questioned the statement that a group 

for purposes of batch reporting is two or 

more EPs, each identified with a unique 

NPI associated with a group practice 

identified under one tax identification 

number (TIN) through the Provider 

Enrollment, Chain, and Ownership 

System (PECOS). These commenters 

suggested that the difference between 

this definition of a group and the one 

under the Physician Quality Reporting 

System (PQRS) is confusing and should 

be harmonized or aligned. 

Response: Generally we agree with 

the principle of aligning definitions 

when possible. However, this 

rulemaking does not address PQRS 

definitions. Alignment with the current 

PQRS definition would entail changing 

our policy from 2 or more EPs to 25 or 

more EPs. We do not believe the 

benefits of alignment are greater than 

the administrative relief to group 

practices made up of 2 to 24 EPs. 

However, we note that in the Medicare 

Program; Revisions to Payment Policies 

Under the Physician Fee Schedule, DME 

Face-to-Face Encounters, Elimination of 

the Requirement for Termination of 

Non-Random Prepayment Complex 

Medical Review and Other Revisions to 

Part B for CY 2013 proposed rule (77 FR 

44722) we proposed to revise the PQRS 

definitions to 2 or more EPs. If finalized, 

the PQRS definition would align with 

our policy. Therefore, we are finalizing 

our policy that would allow batch 

reporting for groups with 2 (or more) 

EPs that meet the rules for such 

reporting. After consideration of the 

comments, we will establish a file 

format in which groups could submit 

core and menu objective information for 

individual Medicare EPs (including the 

stage of meaningful use the individual 

EP is in, numerator, denominator, 

exclusion, and yes/no information for 

each core and menu objective) and also 

establish a process through which 

groups would submit this batch file for 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54091 

upload as proposed. As noted 

previously, this batch file reporting 

process does not apply to CQM 

reporting, which is discussed in section 

II.B of this final rule. 

After consideration of the public 

comments received, we are finalizing 

this option as proposed. There is no 

accompanying regulation text for this 

policy, as it governs the procedures for 

attestation, but not the meaningful use 

requirements. 

We also sought public comment on a 

group reporting option that measures 

performance at a group, rather than at 

an individual, level (referred to as the 

‘‘group performance’’ option.) Rather 

than proposing a set of rules for such 

group performance, we requested 

comment on a host of topics. Many 

commenters supported a group 

performance option; however, we 

received very few detailed comments on 

many of the specific issues we put forth 

for discussion. Therefore, we continue 

to believe that additional policy 

development is necessary to address 

specifically how group performance 

would operate. We are not finalizing the 

group performance policy at this time, 

as we wish to consider it further. EPs 

will continue to be required to 

individually meet all of the thresholds 

of the core and menu objectives. The 

following comments were received on 

issues relating to group performance. 

We requested comments on the 

definition of ‘‘group,’’ noting that the 

PQRS Group Reporting Option requires 

a physician group practice to have a 

single tax payer identification number 

(TIN), with 25 or more individual 

eligible professionals who have 

reassigned their billing rights to the TIN. 

Commenters responded that 25 is too 

large a number, with some suggesting 4 

to 6, or even 2 or more, as an 

appropriate range. Commenters 

recommended that each EP within the 

TIN, be given the choice of participation 

in the group or individually. Some 

commenters also questioned whether a 

consistent TIN indicates a coherent 

group practice with care coordination. 

We requested comments on whether 

there should be a self-nomination 

process for groups, as in PQRS, or an 

alternative process for identifying 

groups. Commenters generally 

supported self-nomination, if it is a 

simple process. 

We also asked whether groups should 

be required to use the same CEHRT. 

Some commenters believed such a 

requirement would be onerous, 

explaining that in some cases imaging 

providers, such as radiologists have 

their own CEHRT. Other commenters 

supported using the same CEHRT to 

ensure consistent reporting. 

We questioned whether a group could 

be eligible for group reporting if CEHRT 

(same or different) were not available to 

all associated EPs at all locations. Some 

commenters responded yes, that in large 

systems clinics may be added or 

upgraded at different points in time and 

there may be transition times during 

which some clinics may not have 

CEHRT. Commenters stated that a 

threshold could be used to ensure that 

the EHR is available for most of the 

services provided by the group. Others 

stated that, no, groups should be held to 

the same standard; if the group as a 

whole is not eligible, individuals could 

still demonstrate meaningful use on an 

individual basis. 

We requested comment on the 

appropriate policy when a group uses 

multiple certified EHR technologies that 

cannot share data easily. Some 

commenters stated that because the 

group as a whole should still have to 

meet the meaningful use objectives, 

interoperability should not be a barrier 

to group performance. These 

commenters stated that while 

interoperability is the ultimate goal of 

EHR technology, it should not become 

a requirement prematurely and 

providers and vendors are best 

positioned to remedy interoperability 

problems. Commenters also urged us to 

ensure that clearinghouses and software 

vendors are within the scope of the 

covered entities that must comply with 

the rule, although no authority was 

cited for requiring such compliance. 

We questioned how meaningful use 

activities should be calculated, 

particularly when an EP practices 

individually and with a group, or in 

multiple group practices. Some 

commenters stated that meaningful use 

would always be at the group level. 

Others stated that if there are EPs 

practicing across two or more groups, 

then neither group should use the group 

reporting option, as this could result in 

different menu measure selections and 

other complications. Other commenters 

recommended that the EP’s covered 

services be calculated as a whole to 

generate the incentive payment amount 

and separate payments be made to each 

TIN based on the percentage of the EP’s 

covered services that were assigned to 

each TIN. 

We noted that the HITECH Act 

provides EPs who are meaningful users 

an incentive payment equal to 75 

percent of Medicare allowable charges 

for covered professional services 

furnished by the EP in a payment year. 

Thus, we questioned how covered 

professional services performed by EPs 

in some other practice could be assigned 

to another group’s TIN. Commenters 

suggested that groups could submit lists 

of EPs covered under its group 

submission and that have reassigned 

payment to the TIN. The covered 

services should include all covered 

services for the EP, regardless of TIN 

under which the services were billed. 

Commenters asserted that this process is 

not different from the current method in 

which individual EPs that work for 

multiple TINs can still reassign their 

incentive payments to a single TIN. 

Others recommended that for purposes 

of determining the 75 percent, CMS 

should simply limit its analysis to those 

services furnished at that practice. 

We solicited public comment on how 

meaningful use activities performed at 

other groups should be included. Some 

commenters stated that groups should 

attest only for the services within the 

group practice, not services outside of 

the group. These commenters expressed 

concern about not being able to validate 

outside data. 

If meaningful use activities outside 

the group were not included in group 

performance, we asked what the CMS 

policy should be for these activities 

performed outside the group. 

Commenters recommended that only 

the group activities should be 

considered, and that those activities 

performed outside the group should 

essentially be ignored. 

We solicited input on what our policy 

should be if an EP reports as part of a 

group, but he or she actually fails to 

meet a measure individually. 

Commenters generally stated that 

individual performance should be 

subsumed in the group performance. 

They assert that groups will have their 

own internal incentives to ensure that 

EPs are properly using the EHR system. 

Along the same lines, we requested 

information on what should happen if 

an EP rejects a particular objective 

completely. Should such an EP be 

considered a meaningful EHR user as 

long as the EP’s non-participation still 

allows group compliance with a 

percentage threshold? Again, 

commenters recommended 

measurement solely at the group level. 

Again, they stated that the group 

practice would have its own incentives 

to ensure EPs within the group properly 

use CEHRT. 

We questioned how yes/no objectives 

should be handled in group reporting. 

Commenters again recommended 

measurement at the group level: A yes 

would mean that the group has 

‘‘enabled’’ and is using that 

functionality of its CEHRT. 

mstockstill on DSK4VPTVN1PROD with RULES2

54092 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

We questioned how group 

performance would operate in cases 

when some EPs in the group participate 

in Medicaid while others participate in 

Medicare. Commenters stated that 

groups could provide lists of EPs and 

indicate which EPs are covered under 

Medicare versus Medicaid. However, in 

any case we, could also encourage states 

to accept the group’s submission as 

applying to Medicaid, as well as 

Medicare. While another commenter 

suggested that Medicare should be the 

default choice for a group, unless they 

all participate in Medicaid. 

As to our question of whether any 

incentive payment would be reassigned 

to the group automatically, or whether 

the EP would assign it to the group at 

registration, commenters gave 

conflicting recommendations. Some 

stated that individual EPs could 

reassign incentive payments to a TIN, 

and that the group could, at the end of 

the period, present a list of EPs who are 

within the TIN and reassigned payment 

to such TIN. Others favored automatic 

reassignment to the group 

demonstrating group performance, 

particularly when an EP is employed or 

contracts with only one group, or when 

a state does not permit assignment to an 

entity promoting the adoption of EHR 

technology. A commenter requested 

clarification on how an EP joining 

midyear would be handled. 

We requested comments on the 

policies that would apply if an EP 

participates in one group’s performance 

and the incentive payment were 

reassigned to the group automatically, 

but the EP also has covered services 

billed to other TINs. Commenters stated 

that if an EP leaves a group, there 

should be a mechanism for reporting 

this and allowing the EP to report 

individually or become part of another 

group; regardless, the automatic 

reassignment should stand. 

We solicited information on how to 

address situations when an EP leaves a 

group during an active EHR reporting 

period. Commenters recommended that 

incentives could be pro-rated on this 

basis, perhaps with ‘‘beginning and 

ending dates’’ included in the group 

performance file to streamline the 

proration. 

We requested information regarding 

payment adjustments, and whether they 

should also be applied at the group 

level. Some stated that group 

performance should be consistent at the 

incentive and payment adjustment 

phases of the EHR Incentive Program. 

Thus, if groups can receive incentives 

based on group performance, then group 

performance should also dictate 

payment adjustments at a group level. 

Others favored maintaining payment 

adjustments at the individual EP level. 

Finally, we solicited alternative 

options for reporting meaningful use, 

while capturing necessary data. One 

commenter recommended a ‘‘sub-TIN’’ 

group reporting option where a specific 

department, specialty or clinic could 

report performance on a group basis. 

2. Data Collection for Online Posting, 

Program Coordination, and Accurate 

Payments 

In addition to the data already being 

collected under our regulations at 

§ 495.10, we proposed to collect the 

business email address of EPs, eligible 

hospitals and CAHs to facilitate 

communication with providers. We 

proposed to begin collecting the 

information as soon as the registration 

system can be updated following the 

publication of this final rule for both the 

Medicare and Medicaid EHR Incentive 

Programs. We did not propose to post 

this information online. In our 

preamble, we proposed to amend 

§ 495.10 accordingly. However, no 

regulation text appeared. We did not 

receive any comments on our proposal. 

We are finalizing regulation text at 

§ 495.10(a)(3) to collect business email 

address. 

We note that we did not propose any 

changes to the registration for the 

Medicare and Medicaid EHR Incentive 

Programs, to the rules on EPs switching 

between programs, or to the record 

retention requirements in § 495.10. 

We did not propose any changes to 

the registration for the Medicare and 

Medicaid EHR Incentive Programs, to 

the rules on EPs switching between 

programs, or to the record retention 

requirements in § 495.10. 

We did not receive any comments and 

we are finalizing these provisions as 

proposed. 

3. Hospital-Based Eligible Professionals 

Our only proposed changes to the 

definition of hospital-based eligible 

professional were to allow the 

determination of hospital-based to 

continue once the payment adjustments 

go into effect, and to propose that the 

hospital-based analysis at the payment 

adjustment phase would, for Medicare, 

be based on federal FY 2 years prior to 

the payment adjustment year. (See 

proposed § 495.4 and section II.D.2. of 

this final rule.) 

We also requested comments on 

whether the definition of hospital-based 

should be refined to exclude from the 

definition those EPs who are not 

furnishing professional services 

‘‘through the use of the facilities and 

equipment, including qualified 

electronic health records, of the 

hospital’’ (section 1903(t)(3)(D) and 

1848(o)(1)(C)(ii) of the Act). We noted 

that during implementation of Stage 1, 

we were asked about situations where 

clinicians may work in specialized 

hospital units, the clinicians have 

independently procured and utilize 

EHR technology that is completely 

distinct from that of the hospital, and 

the clinicians are capable, without the 

facilities and equipment of the hospital, 

of meeting the eligible professional (for 

example ambulatory, not inpatient) 

definition of meaningful use. We stated 

our belief that such situations would be 

uncommon and might not be 

generalized under the uniform 

definition used by place of service 

codes. 

We specifically requested comments 

on the following subjects: (1) How to 

determine whether specialized hospital 

units are using stand-alone certified 

EHR technology separate from that of 

the hospital; and (2) how to determine 

whether EPs using stand-alone certified 

EHR technology separate from that of 

the hospital are truly not accessing the 

facilities and equipment of the hospital. 

We proposed that hospital facilities and 

equipment would include the physical 

environment needed to support the 

necessary hardware; internet 

connections and firewalls; the hardware 

itself, including servers; and system 

interfaces necessary for demonstrating 

meaningful use, for example, to health 

information exchanges, laboratory 

information systems, or pharmacies. We 

proposed possibly using attestation for 

such elements, and noted our belief that 

any such attestations would be subject 

to audit and the False Claims Act. 

We also requested comments on 

whether the criteria for ambulatory 

EHRs and the meaningful use criteria 

that apply to EPs could be met in cases 

where EPs are primarily providing 

inpatient or Emergency Department 

services. By definition, the EPs affected 

by this issue are those who provide 90 

percent or more of their services in the 

inpatient or emergency department, and 

who provide less than 10 percent of 

their services, and possibly none, in 

outpatient settings. However, since the 

beginning of the program, we have been 

clear that for EPs, meaningful use 

measures will not include patient 

encounters that occur within the 

inpatient or emergency departments 

(POS 21 or 23). See for example, FAQ 

10068, 10466, and FAQ 10462 at http:// 

questions.cms.gov or in section 

II.A.3.d.(2). of this final rule. 

Some of our meaningful use criteria 

for EPs are measured based on office 

visits (clinical summaries) and others 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54093 

assume an outpatient type of setting 

(patient reminders). The certification 

rules at 45 CFR part 170 differentiate 

between ambulatory and inpatient 

EHRs, and we requested comments on 

whether the EPs in this case would have 

inpatient or ambulatory technology. 

Comment: We received detailed 

comments addressing the majority of the 

questions we asked about how EPs 

would demonstrate they are not 

hospital-based were we to revise our 

definition of hospital-based to exclude 

EPs using stand-alone CEHRT separate 

from that of the hospital. These 

comments explained in a 

comprehensive manner how EPs use 

stand-alone CEHRT separate from that 

of the hospital, and also provide the 

facilities and equipment that make the 

use of CEHRT possible, including 

internet connections and firewalls. 

Commenters supported using the 

ambulatory certification criteria and the 

EP meaningful use objectives and 

measures with the inclusion of inpatient 

and emergency department encounters 

in meeting such measures. 

Response: Given such comprehensive 

comments, we believe that it is possible 

for EPs to provide CEHRT in the 

hospital environment, that is, 

sufficiently independent of the facilities 

and equipment, including qualified 

electronic health records, of the 

hospital. In the Stage 1 final rule, we 

explained why we were not interpreting 

the statute to provide for individualized 

determinations of whether EPs were 

hospital-based. We focused on language 

in the statute stating that ‘‘The 

determination of whether an eligible 

professional is a hospital-based eligible 

professional shall be made on the basis 

of the site of service.’’ (See 75 FR 44440 

through 44441). We continue to believe 

that this interpretation was reasonable 

based on the Congressional directive 

regarding site of service. However, we 

are now persuaded that the statute is 

also capable of the interpretation 

advanced by the commenters. Thus, 

while we continue to believe our prior 

interpretation was proper, we are 

convinced that other permissible 

interpretations may also be put forward 

through rulemaking. Therefore, we have 

added a new § 495.5 to allow us to 

exclude EPs who can demonstrate to us 

that the EP funds the acquisition, 

implementation, and maintenance of 

Certified EHR Technology, including 

supporting hardware and any interfaces 

necessary to meet meaningful use 

without reimbursement from an eligible 

hospital or CAH; and uses such 

Certified EHR Technology in the 

inpatient or emergency department of a 

hospital (instead of the hospital’s 

CEHRT). 

Once an EP registers for a given year 

they will know whether they are 

hospital based or not. An EP who is 

designated as hospital based, but wishes 

to be determined non hospital-based 

due to their funding of the acquisition, 

implementation and maintenance of 

CEHRT, including supporting hardware; 

and use of such CEHRT at a hospital, in 

lieu of using the CEHRT of such 

hospital will utilize an administrative 

process throughout the incentive 

payment year (and extending 2 months 

after the end of the incentive payment 

year) to provide documentation and 

seek a non-hospital based 

determination. Following a successful 

non-hospital based determination, the 

EP must attest each subsequent year that 

they continue to be in the same 

situation of funding of the acquisition, 

implementation and maintenance of 

CEHRT, including supporting hardware; 

and use of such CEHRT at a hospital 

without reimbursement from an eligible 

hospital or CAH, in lieu of using the 

Certified EHR Technology of such 

hospital, but would not have to provide 

the supporting documentation again. If 

and when a nonhospital-based 

determination has been made, the EP 

would then have to meet the same 

requirements of the EHR incentive 

program as any other EP including being 

subject to payment adjustments if 

applicable with a sole exception: The EP 

would include in their attestation to 

meaningful use all encounters at all 

locations, including those in the 

inpatient and emergency departments of 

the hospital, rather than just outpatient 

locations (other than the emergency 

department) as is the case for all other 

EPs. 

4. Interaction With Other Programs 

There were no proposed changes to 

the ability of providers to participate in 

the Medicare and Medicaid EHR 

Incentive Programs and other CMS 

programs, and we are not finalizing any 

new policies in this area. We continue 

to work on aligning the data collection 

and reporting of the various CMS 

programs, especially in the area of 

clinical quality measurement. See 

section II.B. of this final rule for the 

proposed alignment initiatives for 

clinical quality measures. 

Comment: Several commenters 

suggested changes to other CMS 

programs. 

Response: Our proposed rule 

included policies for the EHR incentive 

program, and not other programs. 

Therefore, we are not addressing 

comments on rules other than the EHR 

incentive program, as these programs 

are outside the scope of this rulemaking. 

D. Medicare Fee-for-Service 

1. General Background and Statutory 

Basis 

As we discussed in the Stage 1 final 

rule, sections 4101(b) and 4102(b) of the 

HITECH Act provide for reductions in 

payments to EPs, hospitals, and CAHs 

that are not meaningful users of CEHRT; 

beginning in CY 2015 for EPs, FY 2015 

for hospitals, and in cost reporting 

periods beginning in FY 2015 for CAHs. 

We discuss the specific statutory 

requirements for each of these payment 

reductions in the following three 

sections. In these sections, we also 

present our specific policies for 

implementing these mandatory payment 

reductions. 

2. Payment Adjustment Effective in CY 

2015 and Subsequent Years for EPs Who 

Are Not Meaningful Users of CEHRT for 

an Applicable Reporting Period 

Section 1848(a)(7) of the Act, as 

amended by section 4101(b) of the 

HITECH Act, provides for payment 

adjustments effective for CY 2015 and 

subsequent years for EPs, as defined in 

§ 495.100 of the regulations, who are not 

meaningful EHR users during the 

relevant EHR reporting period for the 

year. In general, beginning in 2015, if an 

EP is not a meaningful EHR user for the 

EHR reporting period for the year, then 

the Medicare physician fee schedule 

(PFS) amount for covered professional 

services furnished by the EP during the 

year (including the fee schedule amount 

for purposes of determining a payment 

based on the fee schedule amount) is 

adjusted to equal the ‘‘applicable 

percent’’ (defined later) of the fee 

schedule amount that will otherwise 

apply. As we also discuss later, the 

HITECH Act includes an exception, 

which, if applicable, could exempt 

certain EPs from this payment 

adjustment. The payment adjustments 

do not apply to hospital-based EPs. 

The term ‘‘applicable percent’’ is 

defined in the statute to mean: ‘‘(I) for 

2015, 99 percent (or, in the case of an 

eligible professional who was subject to 

the application of the payment 

adjustment [if the EP is not a successful 

electronic prescriber] under section 

1848(a)(5) of the Act for 2014, 98 

percent); (II) for 2016, 98 percent; and 

(III) for 2017 and each subsequent year, 

97 percent.’’ 

In addition, section 1848(a)(7)(iii) of 

the Act provides that if, for CY 2018 and 

subsequent years, the Secretary finds 

that the proportion of EPs who are 

meaningful EHR users is less than 75 

mstockstill on DSK4VPTVN1PROD with RULES2

54094 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

percent, the applicable percent shall be 

decreased by 1 percentage point for EPs 

who are not meaningful EHR users from 

the applicable percent in the preceding 

year, but that in no case shall the 

applicable percent be less than 95 

percent. 

Section 1848(a)(7)(B) of the Act 

provides that the Secretary may, on a 

case-by-case basis, exempt an EP who is 

not a meaningful EHR user for the 

reporting period for the year from the 

application of the payment adjustment 

if the Secretary determines that 

compliance with the requirements for 

being a meaningful EHR user would 

result in a significant hardship, such as 

in the case of an EP who practices in a 

rural area without sufficient Internet 

access. The exception is subject to 

annual renewal, but in no case may an 

EP be granted an exception for more 

than 5 years. 

a. Applicable Payment Adjustments in 

CY 2015 and Subsequent Calendar 

Years for EPs Who Are Not Meaningful 

Users of CEHRT 

Consistent with these provisions, in 

the Stage 1 final rule (75 FR 44572), we 

provided in § 495.102(d)(1) and (2) that, 

beginning in CY 2015, if an EP is not a 

meaningful EHR user for an EHR 

reporting period for the year, then the 

Medicare PFS amount that will 

otherwise apply for covered 

professional services furnished by the 

EP during the year will be adjusted by 

the following percentages: for 2015, 99 

percent (or, in the case of an EP who 

was subject to the application of the 

payment adjustment for e-prescribing 

under section 1848(a)(5) of the Act for 

2014, 98 percent); (2) for 2016, 98 

percent; and (3) for 2017 and each 

subsequent year, 97 percent. 

However, while we discussed the 

application of the additional adjustment 

for CY 2018 and subsequent years if the 

Secretary finds that the proportion of 

EPs who are meaningful EHR users is 

less than 75 percent in the preamble to 

the final rule (75 FR 44447), we did not 

include a specific provision for this 

adjustment in the regulations text. 

Therefore, we proposed to revise the 

current regulations, to provide 

specifically that, beginning with CY 

2018 and subsequent years, if the 

Secretary has found that the proportion 

of EPs who are meaningful EHR users 

under § 495.8 is less than 75 percent, 

the applicable percent is decreased by 1 

percentage point for EPs who are not 

meaningful EHR users from the 

applicable percent in the preceding 

year, but that in no case is the 

applicable percent less than 95 percent. 

In the proposed rule, we stated our 

expectation that we would base the 

determination of the proportion of EPs 

each year on the most recent CY for 

which we have sufficient data (that is, 

most likely, the data available as of 

October 1, 2017, as this is the last date 

for EPs to register and attest to 

meaningful use to avoid a payment 

adjustment in CY 2018). We proposed 

that the computation will be based on 

the ratio of EPs who have qualified as 

meaningful users in the numerator, to 

Medicare-enrolled EPs in the 

denominator. In the proposed rule we 

also explained that because hospitalbased EPs and EPs are granted an 

exception meet the definition of ‘‘EP,’’ 

we would not include such EPs in the 

denominator, because such EPs would 

not be subject to a determination of 

meaningful use status ‘‘under 

subsection (o)(2).’’ We also stated that 

we would provide more specific detail 

on this computation in future guidance 

after the final regulation is published. 

In general terms, the two 

aforementioned provisions for payment 

adjustments to EPs who are not 

meaningful users of EHR technology 

have the following effects for CY 2015 

and subsequent years. The adjustment 

to the Medicare PFS amount that will 

otherwise apply for covered 

professional services furnished by the 

EP will be 99 percent in CY 2015. 

However, for CY 2015 the adjustment 

for an EP who, in CY 2014, was subject 

to the application of the payment 

adjustment for e-prescribing under 

section 1848(a)(5) of the Act will be 98 

percent of the Medicare PFS amount. In 

CY 2016, the adjustment to the 

Medicare PFS amount that will 

otherwise apply will be 98 percent. 

Similarly, the adjustment to the 

Medicare PFS amount that will 

otherwise apply will be 97 percent in 

CY 2017. Depending on whether the 

proportion of EPs who are meaningful 

EHR users is less than 75 percent, the 

adjustment to the Medicare PFS amount 

can be as low as 96 percent in CY 2018, 

and 95 percent in CY 2019 and 

subsequent years. 

We did not receive any comments on 

our proposed methodology for making 

the determination of the applicable 

payment adjustment for Medicare EPs, 

including our proposed methodology for 

making the ‘‘75 percent determination’’ 

beginning for CY2018. Therefore, we are 

finalizing these provisions as proposed. 

We noted in our proposed rule that 

some eligible professionals may be 

eligible for both the Medicare and 

Medicaid EHR incentives, and have 

opted for the Medicaid EHR incentive. 

Under that program, in the first year of 

their participation, EPs may be eligible 

for an incentive payment for having 

adopted, implemented, or upgraded 

(AIU) to CEHRT. However, AIU does not 

constitute meaningful use of CEHRT. 

Therefore, those EPs who receive an 

incentive payment for AIU will not be 

considered meaningful EHR users for 

purposes of determining whether EPs 

are subject to the Medicare payment 

adjustment. Medicaid EPs who meet the 

first year requirements through AIU in 

either 2013 or 2014 will still be subject 

to the Medicare payment adjustment in 

2015 if they are not meaningful EHR 

users for the applicable reporting 

period. However, Medicaid EPs can, 

avoid this consequence by making sure 

that they meet meaningful use in 2013 

(or 2014 if this is the first year of 

demonstrating meaningful use). Since 

the Medicaid EHR Incentive Program 

allows EPs to initiate as late as 2016, 

AIU can still be an important initial step 

for providers who missed the window to 

avoid the Medicare penalties, assuming 

they then demonstrate meaningful use 

in the subsequent year. 

Comment: Commenters stated 

universal support for our proposal that 

EPs who are meaningful EHR users 

under the Medicaid EHR Incentive 

Program for an applicable reporting 

period will also be considered 

meaningful EHR users for that period for 

purposes of avoiding the Medicare 

payment adjustments. 

Response: We agree with commenters 

and are finalizing this provision as 

proposed for the reasons outlined in the 

proposed rule. 

Comment: A few commenters 

suggested that we allow Medicaid AIU 

to be used to avoid the payment 

adjustment. 

Response: The statute (section 

1848(a)(7) of the Act) specifically 

requires that the Medicare payment 

adjustment be applied to an EP ‘‘who is 

not a meaningful EHR user * * * for an 

EHR reporting period for the payment 

year.’’ As we have discussed previously, 

AIU does not involve the demonstration 

of meaningful use. Therefore, we cannot 

accept the commenters’ 

recommendation that demonstration of 

AIU be accepted to allow an EP to avoid 

the Medicare payment adjustment. 

After consideration of the public 

comments received, we are finalizing 

these provisions as proposed. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54095 

TABLE 11—PERCENT ADJUSTMENT FOR CY 2015 AND SUBSEQUENT YEARS, ASSUMING THAT, FOR CY 2018 AND

SUBSEQUENT YEARS, THE SECRETARY FINDS THAT LESS THAN 75 PERCENT OF EPS ARE MEANINGFUL EHR USERS

EPs who are non-meaningful users 2015 2016 2017 2018 2019 2020+ 

EP is not subject to the payment adjustment for e-prescribing in 2014 ............................................................ 99% 98% 97% 96% 95% 95% 

EP is subject to the payment adjustment for e-prescribing in 2014 ............................................................ 98 98 97 96 95 95 

TABLE 12—PERCENT ADJUSTMENT FOR CY 2015 AND SUBSEQUENT YEARS, ASSUMING THAT THE SECRETARY ALWAYS

FINDS THAT, FOR CY 2018 AND SUBSEQUENT YEARS, AT LEAST 75 PERCENT OF EPS ARE MEANINGFUL EHR USERS

EPs who are non-meaningful users 2015 2016 2017 2018 2019 2020+ 

EP is not subject to the payment adjustment for e-prescribing in 2014 ............................................................ 99% 98% 97% 97% 97% 97% 

EP is subject to the payment adjustment for e-prescribing in 2014 ............................................................ 98 98 97 97 97 97 

Comment: A commenter noted use of 

the word, ‘‘during,’’ in section 

1848(a)(7) of the Act, which states: 

‘‘* * * if the eligible professional is not 

a meaningful EHR user (as determined 

under subsection (o)(2) for an EHR 

reporting period for the year, the fee 

schedule amount for such services 

furnished by such professional during 

the year (including the fee schedule 

amount for purposes of determining a 

payment based on such amount) shall 

be equal to the applicable percent of the 

fee schedule amount that would 

otherwise apply to such services under 

this subsection (determined after 

application of paragraph (3) but without 

regard to this paragraph).’’ The 

commenter asserted that the phrase 

‘‘during the year’’ allows the Secretary 

to apply the payment adjustment for any 

amount of time during the year and does 

not require that the payment adjustment 

be applied for the entire year. 

Response: We disagree with this 

interpretation. Other parts of the statute 

clearly show the payment adjustment 

applies for a year at a time, and the 

Congress’ intent was to have the 

physician fee schedule adjusted for an 

entire calendar year (that is, 99 percent 

(or 98 percent) in 2015, 98 percent in 

2016, 97 percent in 2017, and so on.) 

The interpretation presented by the 

commenters would lead to absurd 

results, because it would allow the 

payment adjustment to be minimized to 

the point where it has no impact on the 

EP. 

Therefore, we are finalizing the 

payment adjustment percentages and 

time periods as proposed. 

b. EHR Reporting Period for 

Determining Whether an EP Is Subject 

to the Payment Adjustment for CY 2015 

and Subsequent Calendar Years 

In the Stage 1 final rule, we did not 

specifically discuss the EHR reporting 

periods that will apply for purposes of 

determining whether an EP is subject to 

the payment adjustments for CY 2015 

and subsequent years. Section 

1848(a)(7)(E)(ii) of the Act provides 

broad authority for the Secretary to 

choose the EHR reporting period for this 

purpose. Specifically, this section 

provides that ‘‘term ’EHR reporting 

period’ means, with respect to a year, a 

period (or periods) specified by the 

Secretary.’’ Thus, the statute neither 

requires that such reporting period fall 

within the year of the payment 

adjustment, nor precludes the reporting 

period from falling within the year of 

the payment adjustment. 

In developing our proposals in the 

case of EPs, we sought to establish 

appropriate reporting periods for 

purposes of the payment adjustments in 

CY 2015 and subsequent years to avoid 

creating a situation in which it might be 

necessary either to recoup 

overpayments or make additional 

payments after a determination is made 

about whether the payment adjustment 

should apply. We noted that this 

consideration is especially important in 

the case of EPs because, unlike the case 

with eligible hospitals and CAHs, there 

is not an existing mechanism for 

reconciliation or settlement of final 

payments subsequent to a payment year, 

based on the final data for the payment 

year. (Although, as we discussed in 

relation to our proposals on the 

payment adjustments for eligible 

hospitals in CY 2015 and subsequent 

years, this consideration also carries 

significant weight even where such a 

reconciliation or settlement mechanism 

is available.) Similarly, we did not want 

to create any scenarios under which 

providers would be required either to 

refund money, or to seek additional 

payment from beneficiaries, due to the 

need to recalculate beneficiary 

coinsurance after a determination of 

whether the payment adjustment should 

apply. If we were to establish EHR 

reporting periods that run concurrently 

with the payment adjustment year, we 

would not be able to safeguard against 

such retroactive adjustments 

(potentially including adjustments to 

beneficiary copayments, which are 

determined as a percentage of the 

Medicare PFS amount). 

Therefore, we proposed that EHR 

reporting periods for payment 

adjustments will begin and end prior to 

the year of the payment adjustment. 

Furthermore, we proposed that the EHR 

reporting periods for purposes of such 

determinations will be far enough in 

advance of the payment adjustment year 

to give us sufficient time to implement 

the system edits necessary to apply any 

required adjustments correctly, and that 

EPs will know in advance of the 

payment adjustment year whether or not 

they are subject to the adjustments that 

we have discussed. Specifically, we 

proposed that the following rules would 

apply for establishing the appropriate 

reporting periods for purposes of 

determining whether EPs are subject to 

the payment adjustments in CY 2015 

and subsequent years: 

• Except as provided in the following 

bulleted paragraph for EPs who become 

meaningful users for the first time in 

2014, we proposed that the EHR 

reporting period for the 2015 payment 

adjustment would be the same EHR 

reporting period that applies in order to 

receive the incentive for payment year 

mstockstill on DSK4VPTVN1PROD with RULES2

54096 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

2013. We stated that this proposal 

would align reporting periods for 

multiple physician reporting programs. 

For EPs we proposed that the period 

would generally be a full calendar year 

of 2013 (unless 2013 is the first year of 

demonstrating meaningful use, in which 

case a 90-day EHR reporting period 

would apply). Under our proposed 

policy, an EP who receives an incentive 

for payment year 2013 would be exempt 

from the payment adjustment in 2015. 

An EP who received an incentive for 

payment years in 2011 or 2012 (or both), 

but who failed to demonstrate 

meaningful use in 2013 would be 

subject to a payment adjustment in 

2015. (As all of these years will be for 

Stage 1 of meaningful use, we stated our 

belief that it is unnecessary to create a 

special process to accommodate 

providers that miss the 2013 year for 

meaningful use). For each year 

subsequent to CY 2015, we proposed an 

EHR reporting period for the payment 

adjustment that is the calendar year 2 

years prior to the payment adjustment 

period, subject again to the special 

exception for new meaningful users of 

the CEHRT as follows: 

• We proposed an exception for those 

EPs who never successfully attested to 

meaningful use prior to CY 2014. For 

these EPs, as it would be their first year 

of demonstrating meaningful use, for the 

2015 payment adjustment, we proposed 

to allow a continuous 90-day reporting 

period that begins in 2014 and that ends 

at least 3 months before the end of CY 

2014. In addition, the EP would have to 

successfully register for and attest to 

meaningful use no later than the date 

that occurs 3 months before the end of 

CY 2014. For EPs, we stated that under 

our proposal, the latest day the EP must 

successfully register for the incentive 

program and attest to meaningful use, 

and thereby avoid application of the 

adjustment in CY 2015, would be 

October 1, 2014. Thus, the EP’s EHR 

reporting period would need to begin no 

later than July 3, 2014 (allowing the EP 

a 90-day EHR reporting period, followed 

by 1 extra day to successfully submit the 

attestation and any other information 

necessary to earn an incentive 

payment). We proposed that this policy 

would continue to apply in subsequent 

years for EPs who are in their first year 

of demonstrating meaningful use in the 

year immediately preceding the 

payment adjustment year. 

Comment: Many commenters 

disagreed with our interpretation of the 

statute. These commenters asserted that 

both the Congressional intent and the 

language of the statute required an EHR 

reporting period aligned with the 

payment adjustment year. Thus, these 

commenters maintained that an EP 

should be subject to a payment 

adjustment during a payment year only 

if he or she fails to demonstrate 

meaningful use during that payment 

year. These commenters proposed 

several alternative methods for 

employing an EHR reporting period that 

is concurrent to the payment adjustment 

year for EPs. These recommended 

methods involved either making a 

determination of meaningful use early 

in a payment year, and then applying 

the payment adjustment (where 

applicable) for only a later part of the 

year, or developing a reconciliation 

process at the end of the year in which 

the payment adjustment is either 

collected from or refunded to the EP as 

appropriate. 

Response: We disagree with the 

commenters’ interpretation of the 

statutory language. As the commenters 

note, section 1848(a)(7) of the SSA 

specifically requires that the Medicare 

payment adjustment be applied to an EP 

‘‘who is not a meaningful EHR user 

* * * for an EHR reporting period for 

the payment year.’’ However, as we 

discussed in the proposed rule, section 

1848(a)(7)(E)(ii) of the Act specifically 

provides that ‘‘term ‘EHR reporting 

period’ means, with respect to a year, a 

period (or periods) specified by the 

Secretary.’’ Thus, the statute neither 

requires that such reporting period fall 

within the year of the payment 

adjustment, nor precludes the reporting 

period from falling within the year of 

the payment adjustment. Rather, the 

statute allows the Secretary the 

discretion to set the EHR reporting 

period and link to a year of payment 

adjustments. Indeed, given that 

Congress directed that the payment 

reduction that is applied to the 

physician fee schedule also apply for 

purposes of determining coinsurance, 

we believe there was an underlying 

intent to ensure that the physician fee 

schedule amount (and whether a 

percentage reduction applies) would be 

known at the time coinsurance is 

calculated. This would explain why 

Congress provided flexibility to the 

Secretary in determining which 

reporting period dictates whether the EP 

is subject to a payment adjustment. 

Finally, we note that other payment 

adjustment programs, such as the eprescribing program, and the physician 

quality reporting system, also use a 

prior reporting period. Thus, it is 

consistent for us to adopt a prior 

reporting period for the EHR program as 

well. 

Comment: Commenters also raised 

two more practical objections to our 

proposal to use a prior EHR reporting 

period. One objection is that there is 

insufficient vendor capacity for all 

providers to purchase CEHRT and 

achieve meaningful use prior to 2015, in 

order to avoid the payment adjustment 

in 2015. Some of these commenters 

asserted that the practical deadline for 

beginning the process of adopting and 

implementing CEHRT has already 

passed for some popular vendors; thus, 

vendor choice is limited by the 

proposed timeline. Commenters also 

assert that this issue is compounded 

because EHR vendors must upgrade 

current clients to 2014 CEHRT at 

roughly the same time. 

Response: We understand the 

commenters’ concerns. However, EPs 

have known for several years that they 

would face a payment adjustment 

beginning in 2015, and we believe that 

they have thus had adequate time to 

make appropriate preparations. During 

the last 2 years there has been a 

significant adoption of CEHRT with 

over 100,000 EPs receiving an incentive 

for adoption/implementation/upgrade 

or meaningful use. We also 

acknowledge the concerns expressed by 

many commenters about vendor 

capacity, and especially about whether 

every vendor will be available to every 

EP seeking to establish meaningful use. 

We note that to avoid the payment 

adjustment in 2015, all providers will be 

required to establish only Stage 1 of 

meaningful use in the applicable 

reporting period. For the payment 

adjustment in 2016, only those who first 

demonstrated meaningful use in 2011 or 

2012 will have to demonstrate Stage 2 

in the applicable reporting period and 

we are finalizing a shorter EHR 

reporting period for these EPs to 

account for the time limitations. We also 

believe other factors outweigh the 

concerns noted by commenters. As 

discussed previously, we do not believe 

the statute should be read to allow 

payment adjustments for only part of 

the year. Each of the other alternative 

suggestions presented by commenters 

would require reprocessing of claims for 

EPs, as well as addressing the difficult 

issue of how to adjust co-insurance in 

the context of this reprocessing (that is, 

to refund some coinsurance or to collect 

additional coinsurance, depending upon 

the results of the reprocessing on each 

claim). The administrative and financial 

cost of the reprocessing that would be 

required would be quite significant for 

both CMS and the affected EPs. 

Especially for smaller dollar claims, it is 

possible that in 2015 the cost of 

reprocessing for CMS and EPs could 

exceed that payment adjustment. For 

example, a claim of $100 will be 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54097 

reduced $1 or $2 in CY 2015. If that 

claim was reprocessed, CMS Medicare 

Administrative Contractors (MACs) 

would have to reprocess the claim, 

utilize the banking system to send the 

payment; the EP’s accounting process 

would have to accept the new payment 

and update the old claim and possibly 

incur the costs of collecting or refunding 

coinsurance. As the payment 

adjustments increase, the balance 

between the cost of the payment 

adjustments weighed against the cost of 

claim reprocessing may shift. In 

addition, as time passes we also 

anticipate that the supply of CEHRT and 

supporting services will increase to 

better match demand, lessening the 

concerns presented by the commenters. 

Therefore, we are finalizing the EHR 

reporting period for determining 

whether an EP is subject to the payment 

adjustment for CY 2015 and subsequent 

calendar years as proposed. The issue 

requiring all providers regardless of 

stage of meaningful use to upgrade to 

2014 CEHRT is addressed by ONC in 

their final rule published elsewhere in 

this issue of the Federal Register. We 

note that all providers, regardless of 

stage, will use a 3-month EHR reporting 

period in 2014. 

c. Exception to the Application of the 

Payment Adjustment to EPs in CY 2015 

and Subsequent Calendar Years 

As previously discussed, section 

1848(a)(7)(B) of the Act provides that 

the Secretary may, on a case-by-case 

basis, exempt an EP from the 

application of the payment adjustments 

in CY 2015 and subsequent CYs if the 

Secretary determines that compliance 

with the requirements for being a 

meaningful EHR user will result in a 

significant hardship, such as in the case 

of an EP who practices in a rural area 

without sufficient Internet access. As 

provided in the statute, the exception is 

subject to annual renewal, but in no 

case may an EP be granted an exception 

for more than 5 years. We note that the 

HITECH Act does not obligate the 

Secretary to grant exceptions. 

Nonetheless, in the proposed rule, we 

expressed our belief that there are 

hardships for which an exception 

should be granted. We therefore 

proposed three types of exceptions in 

the proposed rule and discussed a 

potential fourth. The three proposed 

exceptions were, by definition, time 

limited and we stated that the 

circumstances justifying such 

exceptions should not be present for 

more than 5 years. The fourth exception 

related to certain EPs and did not, by 

definition, involve time limited 

circumstances. Nevertheless, we noted 

that the 5 year limitation is statutory 

and cannot be altered by regulations, 

and that barriers to achieving 

meaningful use should be minimized 

over time. 

Comment: Some commenters 

suggested that the exception be granted 

for an all 5 years rather than an annual 

determination to reduce the burden on 

EPs seeking the exception and the 

burden on CMS to process the 

exceptions. 

Response: Section 1848(a)(7)(B) of the 

Act makes the hardship exception 

subject to annual renewal. Therefore, we 

would not grant an exception for more 

than 1 year unless we are certain that 

the circumstances that qualify an EP for 

an exception will not change for 5 years. 

The only such definitive case is for new 

EPs, and we grant a 2-year exception for 

such new EPs, because the date when an 

individual becomes an EP is a fixed 

point in time and not subject to change. 

However, all other exceptions discussed 

in the proposed rule depend on variable 

circumstances and could change from 

year to year. For example, although the 

exception we are finalizing for certain 

EPs (see § 495.102(d)(4)(iv)) could 

depend on scope of practice, which may 

be relatively fixed, it also depends on 

the ability to control the availability of 

CEHRT, which could easily change from 

year to year. Therefore, for these cases, 

we are not adopting this 

recommendation, and are finalizing a 

requirement for annual renewal. 

As mentioned previously, we 

proposed three specific exceptions and 

a potential fourth in the proposed rule. 

First, we proposed that the Secretary 

may grant an exception to EPs who 

practice in areas without sufficient 

Internet access. We noted that section 

1848(a)(7)(B) of the Act specifically 

allows the Secretary to establish a 

significant hardship ‘‘in the case of an 

eligible professional who practices in a 

rural area without sufficient Internet 

access.’’ However, our proposal 

recognized that a nonrural area may also 

lack sufficient Internet access to make 

complying with the requirements for 

being a meaningful EHR user a 

significant hardship for an EP. 

We noted that exceptions on the basis 

of insufficient Internet connectivity 

must intrinsically be considered on a 

case-by-case basis. Therefore, we 

proposed to require that EPs must 

demonstrate insufficient Internet 

connectivity to qualify for the exception 

through an application process. As we 

discussed in the proposed rule, the 

rationale for this exception is that lack 

of sufficient Internet connectivity 

renders compliance with the meaningful 

EHR use requirements a hardship, 

particularly for meeting those 

meaningful use objectives requiring 

Internet connectivity, such as, summary 

of care documents, electronic 

prescribing, making health information 

available online, and submission of 

public health information. Therefore, 

we proposed that the application must 

demonstrate insufficient Internet 

connectivity to comply with the 

meaningful use objectives and that there 

are insurmountable barriers to obtaining 

such infrastructure, such as a high cost 

of extending the Internet infrastructure 

to their facility. We also proposed that 

an EP must establish the existence of the 

hardship was for the year that is 2 years 

prior to the payment adjustment year. 

Therefore, we proposed to require that 

applications be submitted no later than 

July 1 of the calendar year before the 

payment adjustment year in order to 

provide sufficient time for a 

determination to be made and for the EP 

to be notified about whether an 

exception has been granted prior to the 

payment adjustment year. This 

proposed timeline for submission and 

consideration of hardship applications 

was intended to allow sufficient time to 

adjust our payment systems so that 

payment adjustments are not applied to 

EPs who have received an exception for 

a specific payment adjustment year. 

In our proposed rule, we also 

encouraged EPs to apply for the 

exception as soon as possible, which is 

after the first 90 days (the earliest EHR 

reporting period) of CY 2013. If 

applications are submitted close to or on 

the latest date possible (that is, July 1, 

2014 for the 2015 payment adjustment 

year), then the applications could not be 

processed in sufficient time to conduct 

an EHR reporting period in CY 2014 in 

the event that the application is denied. 

Comment: Commenters stated 

universal support for this exception. 

However, commenters expressed the 

concern about the situation of an EP 

who might have sufficient internet 

access in the 2 years prior, but lose it 

in 2014. 

Response: We are finalizing our 

proposed significant hardship exception 

for insufficient Internet connectivity 

with one modification. We believe that 

it is extremely unlikely that an EP 

would lose sufficient internet access at 

one location. However, an EP may 

relocate to a location without sufficient 

Internet access. Therefore, we are 

finalizing our proposal with the 

modification to allow for the 

demonstration of insufficient internet 

access for any 90-day continuous period 

between the start of the year 2 years 

prior to the payment adjustment year 

and through the application submission 

mstockstill on DSK4VPTVN1PROD with RULES2

54098 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

date of July 1 of the year prior to the 

payment adjustment year. The 90-day 

period should be within this timeframe 

(for example, for payment adjustment 

year 2015, the hardship would need to 

be shown for any continuous 90-day 

period that begins on or after January 1, 

2013 and ends on or before July 1, 2014. 

Second, we proposed to provide an 

exception for new EPs for a limited 

period of time after the EP has begun 

practicing. Newly practicing EPs will 

not be able to demonstrate that they are 

meaningful EHR users for a reporting 

period that occurs prior to the payment 

adjustment year. Therefore, we 

proposed that for 2 years after they 

begin practicing, EPs could receive an 

exception from the payment 

adjustments that will otherwise apply in 

CY 2015 and thereafter. We also 

proposed that, for purposes of this 

exception, an EP who switches 

specialties and begins practicing under 

a new specialty will not be considered 

newly practicing. For example, an EP 

who begins practicing in CY 2015 will 

receive an exception from the payment 

adjustments in CYs 2015 and 2016. 

However, as discussed previously, the 

new EP will still be required to 

demonstrate meaningful use in CY 2016 

in order to avoid being subject to the 

payment adjustment in CY 2017. In the 

absence of demonstrating meaningful 

use in CY 2016, an EP who had begun 

practicing in CY 2015 will be subject to 

the payment adjustment in CY 2017. We 

proposed to employ an application 

process for granting this exception, and 

will provide additional information on 

the timeline and form of the application 

in guidance subsequent to the 

publication of the final rule. 

Comment: Commenters stated 

universal support for this exception in 

public comments, and we are finalizing 

this exception as proposed for the 

reasons outlined in the proposed rule. 

Third, we proposed an additional 

exception in this final rule for extreme 

circumstances that make it impossible 

for an EP to demonstrate meaningful use 

requirements through no fault of her 

own during the reporting period. Such 

circumstances might include: a practice 

being closed down; a hospital closed; a 

natural disaster in which an EHR system 

is destroyed; EHR vendor going out of 

business; and similar circumstances. 

Because exceptions on extreme, 

uncontrollable circumstances must be 

evaluated on a case-by-case basis, we 

proposed to require EPs to qualify for 

the exception through an application 

process. 

Comment: Many commenters 

supported this exception. However a 

number of the supporters requested that 

various circumstances be added to the 

list of example circumstances that we 

provided. These examples dealt 

primarily with concerns related to 

vendors of CEHRT. Specifically, 

commenters were concerned about 

vendors of CEHRT not maintaining their 

certification status, ability to meet 

implementation schedules, and ability 

to find a vendor of CEHRT willing to 

work with them. In addition, 

commenters suggested that the provider 

facing severe financial distress, such as 

bankruptcy or restructuring of debt 

should be included as an example. 

Response: In evaluating these 

circumstances, we considered whether 

first and foremost they met the criteria 

of making it impossible for the EP to 

demonstrate meaningful use 

requirements through no fault of his or 

her own during the EHR reporting 

period. Second, we considered whether 

they establish a definitive circumstance 

that would always rise to the level of the 

exception or whether they would be 

dependent on the individual scenario. 

We are including two examples 

submitted by commenters in the 

preamble of the final rule that match the 

former criteria. First, we would consider 

the case an EP whose CEHRT loses its 

certification either through revocation 

or because the vendor did not upgrade 

their CEHRT to the latest requirements 

as an extreme circumstance that might 

qualify for this exception. Second, we 

would consider the case of an EP 

suffering severe financial distress 

resulting in a bankruptcy or 

restructuring of debt as an extreme 

circumstance that might qualify for this 

exception. 

We require applications to be 

submitted no later than July 1 of the 

calendar year before the payment 

adjustment year in order to provide 

sufficient time for a determination to be 

made and for the EP to be notified about 

whether an exception has been granted 

prior to the payment adjustment year. 

This timeline for submission and 

consideration of hardship applications 

also allows for sufficient time to adjust 

our payment systems so that payment 

adjustments are not applied to EPs who 

have received an exception for a specific 

payment adjustment year. 

The purpose of this exception is to 

accommodate EPs who would have 

otherwise been able to become a 

meaningful EHR user and avoid the 

payment adjustment for a given year in 

the absence of the extreme 

circumstances they face. Therefore, it is 

necessary to establish whether the 

relevant circumstances exist during the 

EHR reporting period for a given 

payment adjustment year rather than the 

payment adjustment year itself. In the 

proposed rule, we explained the 

inherently case-by-case nature of this 

exception request. While we discussed 

circumstances that arise in ‘‘either of the 

2 calendar years before the payment 

adjustment year,’’ our intent was to 

ensure that the regulations recognized 

the two different EHR reporting periods 

for new meaningful users (that is, those 

demonstrating meaningful use for the 

first time in the year immediately prior 

to the payment adjustment year), versus 

current meaningful users (that is, those 

demonstrating meaningful use in the 

calendar year that is two years before 

the payment adjustment year). 

Obviously, a ‘‘current’’ meaningful user, 

who is required under our regulations to 

demonstrate meaningful use in the 

calendar year two years before the 

payment adjustment year, may not 

receive an exception for circumstances 

that occur after that reporting period. 

While a new meaningful user might be 

able to demonstrate that extreme 

circumstances that occurred prior to the 

reporting period continue to warrant an 

exception, we believe the case-by-case 

nature of the exception requests would 

allow such ‘‘new’’ meaningful users this 

opportunity to demonstrate that a 

significant hardship continues to exist 

during the reporting period. Therefore, 

in this final rule, we are clarifying our 

regulation to distinguish between new 

and current meaningful users, to be 

clear that the extreme circumstances 

must exist during the period in which 

the provider would otherwise be 

required to demonstrate meaningful use. 

EPs should apply for this exception on 

the basis of circumstances arising in the 

CY 2 years prior to the payment 

adjustment year, or, in the case of EPs 

who have never attested to meaningful 

use, the year immediately prior to the 

payment adjustment year. 

Finally, we solicited comment on the 

appropriateness of granting a fourth 

exception for EPs meeting certain 

specific general criteria that might 

render demonstration of meaningful use 

very difficult. The criteria that we 

discussed were— 

• Lack of face-to-face or telemedicine 

interaction with patients, thereby 

making compliance with meaningful 

use criteria more difficult. Meaningful 

use requires that a provider collect a 

considerable amount of information 

about the patient and is able transport 

information online (to a PHR, to another 

provider, or to a patient) and is 

significantly easier if the provider has 

direct contact with the patient and a 

need for follow up care or contact. 

Certain physicians often do not have a 

consultative interaction with the 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54099 

patient. For example, pathologist and 

radiologists seldom have direct 

consultations with patients. Rather, they 

typically submit reports to other 

physicians who review the results with 

their patients; 

• Lack of follow up with patients. 

Again, the meaningful use requirements 

for collecting information about the 

patient and transporting information 

online are significantly easier to meet if 

a provider has direct contact with a 

patient and a need to follow-up with the 

patient; and 

• Lack of control over the availability 

of CEHRT at their practice locations. 

In our proposed rule, we stated that 

we did not believe any one of these 

barriers taken independently would 

constitute an insurmountable hardship; 

however, our experience with Stage 1 of 

meaningful use suggests that, taken 

together, they may pose a substantial 

obstacle to achieving meaningful use. 

Therefore, we discussed several options 

in the proposed rule. One option was to 

provide a time-limited, 2-year payment 

adjustment exception for all EPs who 

meet the previous criteria. This 

approach would allow us to reconsider 

this issue in future rulemaking. Another 

option was to provide such an exception 

with no specific time limit. However, 

we noted that even under this less 

restrictive option, by statute no 

individual EP can receive an exception 

for more than 5 years. As discussed 

earlier, we believe the proliferation of 

both CEHRT and health information 

exchange will reduce the barriers faced 

by specialties with less CEHRT adoption 

over time as other providers may be 

providing the necessary data for these 

specialties to meet meaningful use. We 

particularly requested comment on how 

soon EPs who meet the previous criteria 

will reasonably be able to achieve 

meaningful use. 

In the proposed rule, we encouraged 

comment on whether these criteria, or 

additional criteria not accounted for in 

the meaningful use exclusions, 

constitute a significant hardship to 

meeting meaningful use. We indicated 

that we that we would consider whether 

to adopt an exception based on these or 

similar criteria in the final rule, and, if 

so, whether such an exception should 

apply to individual EPs or across-theboard based on specialty or other 

groupings that generally meet the 

appropriate criteria. 

Comment: Numerous commenters 

expressed support for including this 

exception. Some commenters agreed 

with CMS’ assertion that all three 

barriers must be in place for this to be 

considered a significant hardship, while 

others maintained that any one of these 

barriers constitutes a significant 

hardship. Commenters from specific 

groups also presented arguments that 

they face one or more (up to all three) 

of the barriers presented in a sufficiently 

uniform way to have the exception 

apply across the board to their group. 

Response: After reviewing the 

comments on this issue, we believe that 

the hardships presented are significant. 

Some EPs in the specialties that face all 

three barriers have already successfully 

attested to meaningful use. Thus, even 

when all three barriers are present, 

meaningful use may be difficult, but not 

impossible to achieve. In establishing 

the criteria for meaningful use itself, we 

have adopted exclusions and 

constructed the measures to lower the 

first two barriers as much as possible. 

For example, EPs with no office visits 

(that is, without direct patient contact) 

do not have to provide visit summaries, 

nor do they have to provider patient 

reminders. Due to both the allowances 

built into the meaningful use criteria 

and the fact at least a few EPs in nearly 

all specialties have attested to 

meaningful use, we do not believe that 

each barrier stands alone as a significant 

hardship. However, in considering the 

hardships and how they would be 

overcome there are significant 

differences between the first two and 

the latter (lack of control of CEHRT). 

Lack of face-to-face and need for follow 

up are both overcome through robust 

health information exchange. However, 

we do not believe that the existing 

availability health information exchange 

is sufficient to overcome these 

hardships. Therefore, we are finalizing 

an exception for those EPs who lack 

both face-to-face interactions with 

patients and those who lack the need to 

follow up with patients. An EP may 

apply for this exception only on the 

grounds that they meet both of these 

criteria (lack of face-to-face interactions 

and lack the to follow up with patients). 

We consider lack of face-to-face and 

need for follow-up care to be situations 

where the EP has no or nearly no faceto-face patient interactions or need for 

follow-up care. The EP would need to 

demonstrate either a complete lack of 

face-to-face interactions and follow-up 

or that cases of face-to-face interaction 

and follow-up are extremely rare and 

not part of normal scope of practice for 

that EP. 

In reviewing the arguments presented 

for a group determination as well as 

considering common knowledge about 

the scope of practice of various 

specialties, we agree with commenters 

that the specialties of anesthesiology, 

radiology, and pathology lack face-toface interactions and need to follow up 

with patients with sufficient frequency 

to warrant granting an exception to each 

EP with one of these primary 

specialties. We note that 

anesthesiologists do interact with 

patients, but not in a manner that is 

conducive to collecting the information 

needed for many aspects of meaningful 

use. As discussed previously, this 

exemption is subject to annual renewal. 

In future rulemaking we will consider 

whether the proliferation of health 

information exchange or any other 

developments are sufficient to remove 

lack of face-to-face interaction as a 

barrier, and whether the proliferation of 

CEHRT is sufficient to remove lack of 

control over the availability of CEHRT 

as a barrier. We will consider these 

issues in relation both to the exception 

itself and its application to the 

specialties of anesthesiology, radiology, 

and pathology. As such, physicians in 

these three specialties should not expect 

that this exception will continue 

indefinitely, nor should they expect that 

we will grant the exception for the full 

5-year period permitted by statute. We 

will consider the extent to which these 

specialties continue to face these 

barriers in the Stage 3 rule and in other 

future rulemaking. We will also work to 

develop strategies to assist physicians 

who lack face-to-face interactions and 

the need to follow up with patients in 

demonstrating meaningful use. We may 

develop such strategies in the context of 

future rulemaking (for example, the 

Stage 3 rule) or in the form of additional 

guidance to physicians in these 

specialties. We also encourage all 

anesthesiologists, radiologists, and 

pathologists to continue to build out 

their ability to participate in health 

information exchange, adopt CEHRT 

and apply for the Medicare or Medicaid 

EHR incentives. Those seeking the 

Medicare EHR incentives can start 

through 2014, while those seeking the 

Medicaid EHR incentives can start 

through 2016. 

As hospital-based anesthesiologists, 

radiologists, and pathologists are not 

eligible for the incentive and are thus 

exempted from the payment adjustment, 

the exception discussed in this section 

relates to these specialists in 

nonhospital settings. 

With regard to the third barrier (lack 

of control over the availability of 

CEHRT at practice locations), we believe 

that in cases where an EP practices at 

multiple locations just this one barrier 

could be sufficient to constitute a 

significant hardship. In such cases, the 

EP would have to truly have no control 

over the availability of CEHRT. Control 

does not imply final decision-making 

authority. For example, we would 

mstockstill on DSK4VPTVN1PROD with RULES2

54100 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

6Chun-Ju Hsiao, Sandra L. Decker, Esther Hing 

and Jane E. Sisk. Most Physicians Were Eligible For 

Federal Incentives In 2011, But Few Had EHR 

Systems That Met Meaningful Use Criteria, Health 

Affairs, 31, No. 5 (2012). 

7Sandra L. Decker, Eric W. Jamoom and Jane E. 

Sisk. Physicians In Nonprimary Care And Small 

Practices And Those Age 55 And Older Lag In 

Adopting Electronic Health Records Systems, 

Health Affairs, 31, No. 5 (2012). 

generally view EPs practicing in a large, 

corporate, group as having control over 

the availability of CEHRT, because they 

can influence the group’s purchase of 

CEHRT, they may reassign their claims 

to the group, they may have a 

partnership/ownership stake in the 

group, or any payment adjustment 

would affect the group’s earnings, and 

the entire impact would not be borne by 

the individual EP. These EPs can 

influence the availability of CEHRT and 

the group’s earnings are directly affected 

by the payment adjustment. Thus, such 

EPs would not, as a general rule, be 

viewed as lacking control over the 

availability of CEHRT and would not be 

eligible for the hardship exception 

based solely on their membership in a 

group practice that has not adopted 

CEHRT. 

On the other hand, there are EPs who 

practice at multiple locations who truly 

have little to no control over whether 

CEHRT is available at their locations. 

These might include, surgeons using 

ambulatory surgery centers or 

physicians treating patients in a nursing 

home. In these cases, the surgeon or 

physician likely would bear the entire 

impact of any payment adjustment—and 

such adjustment would not affect the 

earnings of the ambulatory surgery 

center or nursing home. In addition, 

because the surgeon or physician merely 

sees patients at the center or home, and 

does not have any other interest in the 

facility, we believe they would exert 

little to no influence over whether the 

nursing home, center, or other similar 

outpatient site adopts and implements 

CEHRT. 

We note that we already have in place 

an eligibility requirement that allows for 

an EP to still qualify as a meaningful 

EHR user even if up to 49.9 percent of 

the EP’s outpatient encounters are in 

locations that lack CEHRT. Thus, our 

exception would apply only in the case 

of EPs practicing in multiple locations 

where the lack of control (as discussed 

previously) exists for a majority (50 

percent or more) of their outpatient 

encounters at such locations, causing 

such EPs to not be eligible to become 

meaningful EHR users. (In addition, we 

wish to make clear that we will not 

grant the exception to EPs that lack 

control in their practice locations but 

where those locations have adopted 

CEHRT would mean that the EP could 

become a meaningful EHR user.) 

For the reasons discussed earlier, we 

have adopted a final regulation that 

allows an EP practicing at multiple 

locations to demonstrate that the EP was 

truly unable to control the availability of 

CEHRT at either one or a combination 

of locations that constitute more than 50 

percent of their outpatient encounters. 

Inpatient hospital and emergency 

department encounters would not be 

included in either the numerator or the 

denominator for purposes determining 

whether the 50 percent threshold is met. 

This approach is consistent with the 

categories of encounters that are 

considered to be outpatient for purposes 

of determining hospital based status. 

(As noted previously, the locations cited 

by the EP for purposes of qualifying for 

this exception could not have CEHRT 

available—otherwise, we would view 

the EP as being potentially able to 

demonstrate meaningful use.) 

After considering the public 

comments, we are finalizing an 

exception by adding a new 

§ 495.102(d)(4)(iv) to the regulations. 

EPs whose primary specialty is listed in 

PECOS as anesthesiology, radiology or 

pathology 6 months prior to the first day 

of the year in which payment 

adjustments that would otherwise apply 

will be deemed to qualify for this 

exception, subject to the 5-year limit 

that applies to all exceptions under this 

paragraph. 

Comment: Many commenters 

requested that these and other 

commenter proposed exceptions apply 

to other programs besides the Medicare 

EHR incentive program. 

Response: This final rulemaking 

focuses on the EHR Incentive program, 

and we did not propose to make 

changes to other programs. We 

encourage interested parties to submit 

comments on proposed rules (if any) for 

those other programs. 

Comment: Commenters suggested the 

following additional exceptions: 

• All EPs over 60 or eligible for Social 

Security and for all practices with 5 or 

fewer physicians. 

• EPs who make a good faith effort, 

but fail to reach the thresholds thereby 

making a distinction between those who 

make an effort and those who do not 

attempt to become meaningful EHR 

user. 

• EP is not practicing for a significant 

period of time during the reporting 

period. 

• EP working in a practice without 

CEHRT changes to a new practice that 

has CEHRT during the reporting period. 

Response: We address each of these in 

turn. We agree that there is evidence 

that older EPs and those in smaller 

practices have been slower to adopt 

CEHRT.6 7 The HITECH Act even 

acknowledged the problems for smaller 

practices by creating assistance 

programs for EPs in individual or small 

practices in Title XIII, section 3012(c)(4) 

of the Act. However, based on 

attestation information submitted to us, 

EPs in both groups are successfully 

meeting meaningful use in significant 

numbers. Therefore, we do not believe 

that either an EP’s age or practice size 

constitutes a significant hardship. In 

addition, we believe it would be 

problematic to exempt a category of EPs 

based on age or size of practice given 

that the intent of the payment 

adjustments and incentives is to ensure 

widespread modernization to electronic 

health records. We do not believe that 

these elements, in themselves, 

demonstrate that the EP experiences a 

‘‘significant hardship’’ in becoming a 

meaningful EHR user. 

The next exception suggested by 

commenters is for EPs who attempt to 

become a meaningful EHR user, but fail 

to do so. Because we have already 

adopted an exception for EPs who face 

circumstances beyond their control, the 

application of this suggested exception 

would necessarily be limited to EPs who 

face normal difficulties, rather than 

significant hardship, in becoming 

meaningful EHR users. Again, the 

statute requires demonstration of a 

significant hardship as the basis for an 

exception, and we do not believe that a 

good faith attempt, in and of itself, 

demonstrates the existence of a 

significant hardship exists sufficient to 

prevent the EP from becoming a 

meaningful EHR user. Furthermore, 

Congress set the benchmark for 

receiving full payment, without being 

subject to payment adjustment, on the 

achievement of meaningful use rather 

than on the attempt to achieve 

meaningful use. Therefore, we do not 

believe that EPs who attempt, but fail, 

to meet meaningful use and do not 

qualify for one of our other exceptions 

should be granted a significant hardship 

exception. 

We also do not believe that it is 

appropriate to establish an exception for 

EPs not practicing for significant time 

periods during the EHR reporting 

period. First, we already proposed (and 

are finalizing) an exception for newly 

practicing EPs. Second, EPs who are not 

newly practicing, but only practice for 

part of the EHR reporting period should 

be able to report in the numerator and 

denominators simply the numbers that 

pertain to the time during which they 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54101 

are practicing. For example, a measure 

based on number of patients seen or 

actions taken would include only those 

patients/actions during the time the EP 

is practicing during the applicable 

reporting period. We recognize that 

some meaningful use measures, such as 

drug-drug and drug-allergy interaction 

checks, require a functionality to be 

enabled for the entire EHR reporting 

period. In this case, the EP would have 

the functionality enabled for the period 

s/he is practicing. 

The final exception suggested by 

commenters is for an EP working in a 

practice without CEHRT who changes to 

a new practice with CEHRT. Again, the 

commenters did not explain why such 

a circumstance, by itself, supports a 

significant hardship that prevents the 

EP from becoming a meaningful EHR 

user. Moreover, if the EP has never 

demonstrated meaningful use he or she 

should have an initial 90-day reporting 

period that allows the EP to demonstrate 

meaningful use in a shorter period. In 

addition, under current guidance, if the 

EP has more than 50 percent of their 

outpatient encounters at the new 

practice equipped with CEHRT then 

they would be able to exclude the old 

practice from their meaningful use 

measures. 

After considering the public 

comments, we are not finalizing these 

exceptions recommended by the 

commenters. The following table 

summarizes the timeline for EPs to 

avoid the applicable payment 

adjustment by demonstrating 

meaningful use or qualifying for an 

exception from the application of the 

payment adjustment: 

TABLE 13—TIMELINE FOR ELIGIBLE PROFESSIONALS (OTHER THAN HOSPITAL-BASED) TO AVOID PAYMENT ADJUSTMENT

EP payment 

adjustment year 

(calendar year) 

Demonstrate MU during EHR reporting 

period 2 years prior to year of payment 

adjustment 

or 

For an EP demonstrating meaningful use 

for the first time in the year prior to the 

payment adjustment year, EHR reporting 

period is a continuous 90-day reporting 

period beginning no later than 

or 

Apply or otherwise 

qualify for an 

exception no later 

than 

2015 .................. CY 2013 (with submission no later than 

February 28, 2014).

July 3, 2014 (with submission no later 

than October 1, 2014).

July 1, 2014. 

2016 .................. CY 2014 (with submission no later than 

February 28, 2015).

July 3, 2015 (with submission no later 

than October 1, 2015).

July 1, 2015. 

2017 .................. CY 2015 (with submission no later than 

February 29, 2016).

July 3, 2016 (with submission no later 

than October 1, 2016).

July 1, 2016. 

2018 .................. CY 2016 (with submission no later than 

February 28, 2017).

July 3, 2017 (with submission no later 

than October 1, 2017).

July 1, 2017. 

2019 .................. CY 2017 with submission no later than 

February 28, 2018).

July 3, 2018 (with submission no later 

than October 1, 2018).

July 1, 2018. 

Notes: (CY refers to the calendar year, January 1 through December 31 each year.) 

The timelines for CY 2020 and subsequent calendar years will follow the same pattern. 

TABLE 14—PERIOD HARDSHIP MUST BE SHOWN WITH APPLICATION DATE

Exception Period of consideration for exception Application for CY 2015 submitted 

no later than 

Insufficient internet access .............. Demonstrate insufficient internet access for any continuous 90-day 

period from the start of the CY 2 years prior to the payment adjustment year to July 1 of the year prior to the payment adjustment 

year (For CY 2015—January 1, 2013–July 1, 2014).

July 1, 2014. 

New EP ........................................... New EP granted an exception for the year they become an EP and 

the following year (For CY 2015, the EP would have to be new in 

either CY 2014 or CY 2015).

Guidance to be issued following 

publication of the final rule. 

Extreme Circumstances outside of 

the EP’s Control.

For an EP who has previously demonstrated meaningful use, the EP 

must demonstrate extreme circumstances that affect either of the 

CYs in the 2 years prior to the payment adjustment year. (For CY 

2015–CY 2013).

July 1, 2014. 

For EPs who have never demonstrated meaningful use, the EP must 

demonstrate extreme circumstances that affect the CY prior to the 

payment adjustment year. (For CY 2015–CY 2014). 

Lack of Face-Face/Telemedicine 

Patient Interactions and Lack of 

Need for Follow Up Care,.

Lack of Control Over Availability of 

CEHRT for EPs practicing in multiple locations. 

The CY 2 years prior to the payment adjustment year (For CY 2015– 

CY 2013) through the application deadline..

For all EPs, if they are registered in PECOS with a primary specialty 

of anesthesiology, pathology or radiology 6 months prior to first day 

of the payment adjustment year they meet the exception. (For CY 

2015—July 1, 2014) 

For applications only: July 1, 2014. 

d. HPSA Bonus Technical Change 

In this final rule we are also making 

a technical change to our regulations to 

correctly reflect our policy on EPs who 

predominantly furnish services in a 

geographic HPSA. This change is 

necessary to reflect the current policy 

that the 50 percent determination is 

based on the covered professional 

services provided during the payment 

year, in accordance with the preamble 

discussion in the Stage 1 final rule (75 

FR 44444 through 44445). The current 

regulation erroneously uses the phrase 

‘‘the year prior to the payment year,’’ 

which conflicts with our preamble 

discussion in both the proposed (75 FR 

1908 through 1909) and final Stage 1 

rules. We note that we are not changing 

the policy (already adopted) that the 

HPSA must be so designated by 

December 31 of the year prior to the 

payment year. 

mstockstill on DSK4VPTVN1PROD with RULES2

54102 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

e. Payment Adjustment Not Applicable 

to Hospital-Based EPs 

Section 1848(a)(7)(D) of the Act 

provides that no EHR payment 

adjustments otherwise applicable for CY 

2015 and subsequent years ‘‘may be 

made * * * in the case of a hospitalbased eligible professional (as defined 

in subsection (o)(1)(C)(ii)) of the Act.’’ 

We proposed that the same definition of 

hospital-based should apply during the 

incentive and payment adjustment 

phases of the Medicare EHR incentive 

program (that is, those eligible to receive 

incentives will also be subject to 

adjustments). Therefore, we proposed 

that our regulations at § 495.100 and 

§ 495.102(d) would retain, during the 

payment adjustment phase of the EHR 

Incentive Program, the definition of 

hospital-based eligible professional at 

§ 495.4. For purposes of the Medicare 

EHR incentive payment program, the 

determination of whether an EP is 

hospital-based is made on the basis of 

data from ‘‘the Federal FY prior to the 

payment year.’’ In the preamble to the 

Stage 1 final rule (75 FR 44442), we also 

stated that ‘‘in order to provide 

information regarding the hospitalbased status of each EP at the beginning 

of each payment year, we will need to 

use claims data from an earlier period. 

Therefore, we will use claims data from 

the prior fiscal year (October through 

September). Under this approach, the 

hospital-based status of each EP will be 

reassessed each year, using claims data 

from the fiscal year preceding the 

payment year. The hospital-based status 

will be available for viewing beginning 

in January of each payment year.’’ 

We proposed to retain the concept 

established in the Stage 1 final rule (75 

FR 44442) of making hospital-based 

determinations based upon a prior fiscal 

year of data. However, in the proposed 

rule we expressed concern about 

ensuring that EPs are aware of their 

hospital-based status in time to 

purchase EHR technology and 

meaningfully use it during the EHR 

reporting period that applies to a 

payment adjustment year. EPs who 

believe that they are not hospital based 

will have already either worked towards 

becoming meaningful EHR users or 

planned for the payment adjustment. 

EPs who believe that they will be 

determined hospital based may not have 

done so. EPs in these circumstances will 

need to know they are not hospital 

based in time to become a meaningful 

EHR user for a 90-day EHR reporting 

period in the year prior to the payment 

adjustment year. To use the example of 

the CY 2015 payment adjustment year, 

a determination based on FY 2013 data 

will allow an EP to know whether he or 

she is hospital-based by January 1, 2014. 

This timeline would give the EP 

approximately 6 months to begin the 

EHR reporting period, which could last 

from July through September of 2014. 

We stated in the proposed rule that we 

did not believe this to be sufficient time 

for the EP to implement CEHRT. 

Therefore, we proposed to base the 

hospital based determination for a 

payment adjustment year on 

determinations made 2 years prior. 

Again using CY 2015 payment 

adjustment year as an example, the 

determination would be available on 

January 1, 2013 based on FY 2012 data. 

This proposed determination date will 

give the EP up to 18 months to 

implement CEHRT and begin the EHR 

reporting period to avoid the CY 2015 

payment adjustment. In the proposed 

rule, we asserted that this a reasonable 

time frame to accommodate a difficult 

situation for some EPs. However, we 

also are aware that there may be EPs 

who are determined nonhospital-based 

under this ‘‘2-years prior’’ policy when 

they will be determined hospital-based 

if we made the determination just 1-year 

prior. Again, using the example of the 

CY 2015 payment adjustment year, an 

EP determined nonhospital-based as of 

January 1, 2013 (using FY 2012 data) 

may be found to be hospital-based as of 

January 1, 2014 (using FY 2013 data). In 

this situation, we stated in the proposed 

rule that we did not believe the EP 

should be penalized for having been 

nonhospital-based as of January 1, 2013, 

especially if the EP has never 

demonstrated meaningful use, and the 

EP’s first EHR reporting period will 

have fallen within CY 2014. Therefore, 

in the proposed rule we requested 

comments on expanding the hospitalbased determination to encompass 

determinations made either 1 or 2 years 

prior. Under this alternative, if the EP 

were determined hospital based as of 

either one of those dates, then the EP 

would be exempt from the payment 

adjustments in the corresponding 

payment adjustment year. This would 

mean that for the CY 2015 payment 

adjustment year, an EP determined 

hospital based as of either January 1, 

2013 (using FY 2012 data) or January 1, 

2014 (using FY 2013 data) would not be 

subject to the payment adjustment. In 

all cases, we would need to know that 

the EP is considered hospital based in 

sufficient time for the payment 

adjustment year. 

Comment: Commenters provided only 

general supportive comments on this 

proposal. 

Response: We thank the commenters 

for the support. For the reasons stated 

in the proposed rule, we are finalizing 

a rule that will determine hospital based 

using either of the following fiscal year’s 

data: (1) The fiscal year before the year 

that is 1 year prior to the payment 

adjustment year (for example, FY 2013 

data for payment adjustment year 2015); 

or (2) the fiscal year before the year that 

is 2 years prior to the payment 

adjustment year (for example, FY 2012 

data for payment adjustment year 2015). 

If the data from either year result in a 

hospital-based determination, then the 

EP would not be subject to the payment 

adjustments for the relevant year. 

We discuss one aspect of determining 

hospital-based status, specifically the 

circumstances of EPs who fund the 

acquisition, implementation, and 

maintenance of their own CEHRT in a 

hospital-based setting, in section II.C.3. 

of the preamble to this final rule. 

3. Incentive Market Basket Adjustment 

Effective in FY 2015 and Subsequent 

Years for Eligible Hospitals That Are 

Not Meaningful EHR Users for an 

Applicable Reporting Period 

Section 1886(b)(3)(B)(ix)(I) of the Act, 

as amended by section 4102(b)(1) of the 

HITECH Act, provides for an adjustment 

to the applicable percentage increase to 

the IPPS payment rate for those eligible 

hospitals that are not meaningful EHR 

users for the associated EHR reporting 

period for a payment year, beginning in 

FY 2015. Specifically, section 

1886(b)(3)(B)(ix)(I) of the Act provides 

that, ‘‘for FY 2015 and each subsequent 

FY,’’ an eligible hospital that is not ‘‘a 

meaningful EHR user * * * for an EHR 

reporting period’’ will receive a reduced 

update to the IPPS standardized 

amount. This reduction will apply to 

‘‘three-quarters of the percentage 

increase otherwise applicable.’’ The 

reduction to three-quarters of the 

applicable update for an eligible 

hospital that is not a meaningful EHR 

user will be ‘‘331⁄3 percent for FY 2015, 

662⁄3 percent for FY 2016, and 100 

percent for FY 2017 and each 

subsequent FY.’’ In other words, for 

eligible hospitals that are not 

meaningful EHR users, the Secretary is 

required to reduce the percentage 

increases otherwise applicable by 25 

percent (331⁄3 percent of 75 percent) in 

2015, 50 percent (662⁄3 percent of 75 

percent) in FY 2016, and 75 percent 

(100 percent of 75 percent) in FY 2017 

and subsequent years. Section 

4102(b)(1)(B) of the HITECH Act also 

provides that such ‘‘reduction shall 

apply only with respect to the FY 

involved and the Secretary shall not 

take into account such reduction in 

computing the applicable percentage 

increase * * * for a subsequent FY.’’ 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54103 

TABLE 15—PERCENTAGE DECREASE IN APPLICABLE HOSPITAL PERCENTAGE INCREASE FOR HOSPITALS THAT ARE NOT

MEANINGFUL EHR USERS

2015 2016 2017+ 

Hospital payment update is subject to EHR payment reduction ............................................................ 25% 50% 75% 

Section 1886(b)(3)(B)(ix)(II) of the Act, 

as amended by section 4102(b)(1) of the 

HITECH Act, provides that the Secretary 

may, on a case-by-case basis exempt a 

hospital from the application of the 

percentage increase adjustment for a 

fiscal year if the Secretary determines 

that requiring such hospital to be a 

meaningful EHR user will result in a 

significant hardship, such as in the case 

of a hospital in a rural area without 

sufficient Internet access. This section 

also provides that such determinations 

are subject to annual renewal, and that 

in no case may a hospital be granted 

such an exemption for more than 5 

years. 

Finally section 1886(b)(3)(B)(ix)(III) of 

the Act, as amended by section 

4102(b)(1) of the HITECH Act, provides 

that, for FY 2015 and each subsequent 

FY, a state in which hospitals are paid 

for services under section 1814(b)(3) of 

the Act shall adjust the payments to 

each eligible hospital in the state that is 

not a meaningful EHR user in a manner 

that is designed to result in an aggregate 

reduction in payments to hospitals in 

the state that is equivalent to the 

aggregate reduction that will have 

occurred if payments had been reduced 

to each eligible hospital in the state in 

a manner comparable to the reduction 

in section 1886(b)(3)(B)(ix)(I) of the Act. 

This section also requires that the state 

shall report to the Secretary the method 

it will use to make the required payment 

adjustment. (At present, section 

1814(b)(3) of the Act applies to the State 

of Maryland.) As we discussed in the 

Stage 1 final rule establishing the EHR 

incentive program (75 FR 44448), for 

purposes of determining whether 

hospitals are eligible for receiving EHR 

incentive payments, we employ the 

CMS Certification Number (CCN). We 

also proposed to use CCNs to identify 

hospitals for purposes of determining 

whether the reduction to the percentage 

increase otherwise applicable for FY 

2015 and subsequent years applies. (In 

other words, whether a hospital was a 

meaningful EHR user for the applicable 

EHR reporting period will be dependent 

on the CCN for the hospital.) We noted 

the results of this policy for certain 

cases in which hospitals change 

ownership, merge, or otherwise 

reorganize and the applicable CCN 

changes. In cases where a single 

hospital changes ownership, we 

determine whether to retain the 

previous CCN or to assign a new CCN 

depending upon whether the new 

owner accepts assignment of the 

provider’s prior participation 

agreement. Where a change of 

ownership has occurred, and a new 

CCN is assigned due to the new owner’s 

decision not to accept assignment of the 

prior provider agreement, we proposed 

not to recognize a meaningful use 

determination that was established 

under the prior CCN for purposes of 

determining whether the payment 

adjustment applies. Where the new 

owner accepts the prior provider 

agreement and is assigned the same 

CCN, we proposed to continue to 

recognize the demonstration of 

meaningful use under that CCN. The 

same policy was proposed for merging 

hospitals that use a single CCN. For 

example, if hospital A is not a 

meaningful EHR user (for the applicable 

reporting period), and it absorbs 

hospital B, which was a meaningful 

EHR user, then the entire hospital will 

be subject to a payment adjustment if 

hospital A’s CCN is the surviving 

identifier. The converse is true as well— 

if it were hospital B’s CCN that 

survived, the entire merged hospital 

will not be subject to a payment 

adjustment. (The guidelines for 

determining CCN assignment in the case 

of merged hospitals are described in the 

State Operations Manual, sections 

2779Aff. http://www.cms.gov/ 

Regulations-and-Guidance/Guidance/ 

Manuals/Internet-Only-Manuals-IOMsItems/CMS1201984.html) We advised 

hospitals that are changing ownership, 

merging, or otherwise reorganizing to 

take this policy into account. 

Comments received on the treatment 

of CCNs and new hospitals are 

addressed in the context of discussing 

our exception for new hospitals later in 

this section. 

a. Applicable Market Basket Adjustment 

for Eligible Hospitals Who Are Not 

Meaningful EHR Users for FY 2015 and 

Subsequent FYs 

In the stage 1 final rule on the 

Medicare and Medicaid Electronic 

Health Record Incentive Payment 

Programs, we revised § 412.64 of the 

regulations to provide for an adjustment 

to the applicable percentage increase 

update to the IPPS payment rate for 

those eligible hospitals that are not 

meaningful EHR users for the EHR 

reporting period for a payment year, 

beginning in FY 2015. Specifically, 

§ 412.64(d)(3) now provides that— 

• Beginning in fiscal year 2015, in the 

case of a ‘‘subsection (d) hospital,’’ as 

defined under section 1886(d)(1)(B) of 

the Act, that is not a meaningful 

electronic health record (EHR) user as 

defined in part 495, three-fourths of the 

applicable percentage change specified 

in paragraph (d)(1) is reduced— 

++ For fiscal year 2015, by 331⁄3

percent; 

++ For fiscal year 2016, by 662⁄3

percent; and 

++ For fiscal year 2017 and 

subsequent fiscal years, by 100 percent. 

In order to conform with this new 

update reduction, as required in section 

4102(b)(1)(A) of the HITECH Act, we 

also revised § 412.64(d)(2)(C) of our 

regulations to provide that, beginning 

with FY 2015, the reduction to the IPPS 

applicable percentage increase for 

failure to submit data on quality 

measures to the Secretary shall be onequarter of the applicable percentage 

increase, rather than the 2 percentage 

point reduction that applies for FYs 

2007 through 2014 in § 412.64(d)(2)(B). 

The effect of this revision is that the 

combined reductions to the applicable 

percentage increase for meaningful EHR 

use and quality data reporting will not 

produce an update of less than zero for 

a hospital in a given FY as long as the 

hospital applicable percentage increase 

remains a positive number. 

We did not propose any changes to 

the establishment of the payment 

adjustment amounts. We did propose 

the applicable EHR reporting period, for 

purposes of determining whether a 

hospital is subject to the applicable 

percentage increase adjustment for FY 

2015 and subsequent FYs, as a prior 

EHR reporting period (as defined in 

§ 495.4 of the regulations). We also 

proposed an amendment to § 412.64(d) 

to provide for the hardship and other 

exceptions we discuss later, as well as 

the application of the applicable 

percentage increase adjustment in FY 

2015 and subsequent FYs to a state 

operating under a payment waiver 

provided by section 1814(b)(3) of the 

Act. We discuss these proposals and the 

mstockstill on DSK4VPTVN1PROD with RULES2

54104 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

comments relating to them in the 

following sections of this preamble. 

b. EHR Reporting Period for 

Determining Whether a Hospital Is 

Subject to the Market Basket 

Adjustment for FY 2015 and Subsequent 

FYs 

Section 1886(b)(3)(B)(ix)(IV) of the 

Act makes clear that the Secretary has 

discretion to ‘‘specify’’ as the EHR 

reporting period ‘‘any period (or 

periods)’’ that will apply ‘‘with respect 

to a fiscal year.’’ Thus, as in the case of 

designating the EHR reporting period for 

purposes of the EP payment adjustment, 

the statute governing the applicable 

percentage increase adjustment for 

hospitals that are not meaningful users 

of EHR technology neither requires that 

such reporting period fall within the 

year of the payment adjustment, nor 

precludes the reporting period from 

falling within the year of the payment 

adjustment. 

As in the case of EPs, we sought to 

avoid creating a situation in which it 

might be necessary to make large 

payment adjustments, either to lower or 

to increase payments to a hospital, after 

a determination is made about whether 

the applicable percentage increase 

adjustment should apply. We stated in 

the proposed rule that we believe that 

this consideration remains compelling 

in the case of hospitals, despite the fact 

that the IPPS for acute care hospitals 

provides, unlike the case of EPs, a 

mechanism to make appropriate 

changes to hospital payments for a 

payment year through the cost reporting 

process. Despite the availability of the 

cost reporting process as a mechanism 

for correcting over- and underpayments 

made during a payment year, we seek to 

avoid wherever possible circumstances 

under which it may be necessary to 

make large adjustments to the rate-based 

payments that hospitals receive under 

the IPPS. Since the EHR payment 

adjustment in FYs 2015 and subsequent 

years is an adjustment to the applicable 

percentage increase used in determining 

prospective payments, we believe that it 

is far preferable to determine whether 

the adjustment applies on the basis of 

an EHR reporting period before the 

payment period, rather than to make the 

adjustment (where necessary) in a 

settlement process after the payment 

period on the basis of a determination 

concerning whether the hospital was a 

meaningful user during the payment 

period. 

Therefore, we proposed, for purposes 

of determining whether the relevant 

applicable percentage increase 

adjustment applies to hospitals who are 

not meaningful users of EHR technology 

in FY 2015 and subsequent years, that 

we would establish EHR reporting 

periods that begin and end prior to the 

year of the payment adjustment. 

Furthermore, we proposed that the EHR 

reporting periods for purposes of such 

determinations would be far enough in 

advance of the payment year that we 

have sufficient time to implement the 

system edits necessary to apply any 

required applicable percentage increase 

adjustment correctly, and that hospitals 

will know in advance of the payment 

year whether or not they are subject to 

the applicable percentage increase 

adjustment. Specifically, we proposed 

the following rules establishing the 

appropriate reporting periods for 

purposes of determining whether 

hospitals are subject to the applicable 

percentage increase adjustment in FY 

2015 and subsequent years (parallel to 

the rules that we proposed previously 

for determining whether EPs are subject 

to the payment adjustments in CY 2015 

and subsequent years): 

• Except as provided in second 

bulleted paragraph for eligible hospitals 

that become meaningful users for the 

first time in 2014, we proposed that the 

EHR reporting period for the FY 2015 

applicable percentage increase 

adjustment will be the same EHR 

reporting period that applies in order to 

receive the incentive for FY 2013. For 

hospitals this will generally be the full 

fiscal year of 2013 (unless FY 2013 is 

the first year of demonstrating 

meaningful use, in which case a 90-day 

EHR reporting period will apply). Under 

our proposed policy, a hospital that 

receives an incentive for FY 2013 would 

be exempt from the payment adjustment 

in FY 2015. A hospital that received an 

incentive for FYs 2011 or 2012 (or both), 

but that failed to demonstrate 

meaningful use for FY 2013 will be 

subject to a payment adjustment in FY 

2015. (As all of these years will be for 

Stage 1 of meaningful use, we do not 

believe that it is necessary to create a 

special process to accommodate 

providers that miss the 2013 year for 

meaningful use). For each year 

subsequent to FY 2015, the EHR 

reporting period payment adjustment 

will continue to be the FY 2 years before 

the payment adjustment period, subject 

again to the special provision for new 

meaningful users of CEHRT. 

• We proposed an exception for those 

hospitals that have never successfully 

attested to meaningful use prior to FY 

2014. For these hospitals, as it is their 

first year of demonstrating meaningful 

use, we proposed to allow a continuous 

90-day reporting period that begins in 

2014 and that ends at least 3 months 

prior to the end of FY 2014. In addition, 

the hospital would have to actually 

successfully register for and attest to 

meaningful use no later than the date 

that occurs 3 months before the end of 

the year. For hospitals, this means 

specifically that the latest day the 

hospital must successfully register for 

the incentive program and attest to 

meaningful use, and thereby avoid 

application of the adjustment in FY 

2015, is July 1, 2014. Thus, the 

hospital’s EHR reporting period must 

begin no later than April 2, 2014 

(allowing the hospital a 90-day EHR 

reporting period, followed by 1 extra 

day to successfully submit the 

attestation and any other information 

necessary to earn an incentive 

payment). In the proposed rule we used 

the date April 3, 2014 which would 

only allow an 89-day period through 

June 30, 2014. The correct date is April 

2, 2014 to allow September 30, 2014 to 

be the last day of the 90-day EHR 

reporting period with the extra day (Oct 

1, 2014) to attest. This policy would 

continue to apply in subsequent years. 

If a hospital is demonstrating 

meaningful use for the first time for the 

fiscal year immediately before the 

applicable percentage increase 

adjustment year, then the reporting 

period will be a continuous 90-day 

period that begins in such prior fiscal 

year and ends at least 3 months before 

the end of such year. In addition, all 

attestation, registration, and any other 

details necessary to determine whether 

the hospital is subject to a applicable 

percentage increase adjustment for the 

upcoming year will need to be 

completed by July 1. (As we discuss 

later, exception requests will be due by 

the April 1 before the beginning of the 

payment adjustment fiscal year.) 

In conjunction with adopting these 

rules for establishing the EHR Reporting 

Period for determining whether a 

hospital is subject to the applicable 

percentage increase adjustment for FY 

2015 and subsequent FYs, we proposed 

to revise § 412.64(d)(3) of our 

regulations to insert the phrase ‘‘for the 

applicable EHR reporting period,’’ so 

that it is clear that the EHR reporting 

period will not fall within the year of 

the market basket adjustment. 

We stated our belief that these 

proposed EHR reporting periods provide 

adequate time both for the systems 

changes that will be required for CMS 

to apply any applicable percentage 

increase adjustments in FY 2015 and 

subsequent years, and for hospitals to be 

informed in advance of the payment 

year whether any adjustment(s) will 

apply. They also provide appropriate 

flexibility by allowing more recent 

adopters of EHR technology a 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54105 

reasonable opportunity to establish their 

meaningful use of the technology and to 

avoid application of the payment 

adjustments. 

Comment: As with the comments on 

the EHR reporting period for EPs, many 

commenters made the same assertion 

that an EHR reporting period aligned 

with the payment adjustment year 

would be more consistent with the 

Congressional intent and the language of 

the statute. Some commenters 

contended that the statutory language 

requires the reporting period and 

payment adjustment year to coincide. 

Response: We believe our response to 

this comment in the context of the EP 

payment adjustments applies equally to 

his eligible hospital comment. The 

language in section 1886(b)(3)(B)(ix)(I) 

of the Act is substantially similar to the 

language in section 1848(a)(7) of the 

Act. As in the case of EPs, Congress 

provided the Secretary with flexibility 

to determine the EHR reporting period 

applicable to the payment adjustment 

year. Section 1886(b)(3)(B)(ix)(IV) of the 

Act specifically provides that ‘‘term 

‘EHR reporting period’ means, with 

respect to a fiscal year, any period (or 

periods) specified by the Secretary.’’ In 

addition, because the payment 

adjustment will be used to reduce the 

applicable percent increase that is used 

in the prospective ratesetting for 

hospitals, it is reasonable to conclude 

that this Secretarial flexibility was 

granted precisely because Congress 

understood that the Department needed 

to have final determinations on 

meaningful use prior to the fiscal year 

that is the payment adjustment year. As 

we have previously noted, other 

payment adjustment programs, such as 

the e-prescribing program, and the 

physician quality reporting system, also 

use a prior reporting period. Thus, it is 

consistent for us to adopt a prior 

reporting period for the EHR program as 

well. 

Comment: Commenters made the 

same comments as they did for EPs 

(relating to insufficient vendor capacity; 

the practical deadline having passed for 

adopting and implementing CEHRT, 

especially for popular vendors; and the 

issues surrounding upgrading current 

clients to 2014 CEHRT). As with EPs, 

the options presented by commenters all 

involved a reconciliation process, in 

this case, using the cost reporting 

process. 

Response: The issue of upgrading to 

2014 CEHRT is addressed by ONC in 

their final rule published elsewhere in 

this issue of the Federal Register. We 

appreciate the concerns of vendor 

capacity raised by the commenters. We 

discuss this situation and the reasons 

we are not revising our timetables in our 

previous discussion of the parallel 

policy for EPs. In the hospital context, 

the commenters correctly point out the 

existence of a payment reconciliation 

method, the hospital cost report, that it 

unavailable within the payment systems 

for EPs. We have carefully considered 

whether it is feasible to adopt a later 

reporting period (perhaps even the 

payment year itself) as the basis for 

determining whether eligible hospitals 

are subject to the EHR payment 

adjustment, and then to employ the cost 

reporting process to correct over and 

under payments in regards to the 

payment adjustments, as a number of 

commenters recommended. As a matter 

of course in the rate setting system, the 

basic rates and applicable percentage 

increase updates are fixed in advance 

and are not matters that are taken into 

account in the settlement of final 

payment amounts under the cost report 

reconciliation process. As the payment 

adjustment directly affects this rate we 

believe that it would not be possible to 

employ a cost report settlement process, 

but that claims would have to be 

reprocessed. 

It is true, as several commenters 

pointed out, that several components of 

the IPPS, including DSH and IME 

payments, are settled in the cost 

reporting process on the basis of final 

data (for example, bed days, resident 

FTEs) from the payment year. However, 

changes in other aspects of the payment 

system, such as outlier payments, 

cannot reconciled within the cost 

reporting process, but require 

reprocessing of claims. Application of 

the EHR payment adjustment changes 

the standardized amount upon which 

IPPS payments are based. Any change in 

the standardized amount applicable to a 

hospital changes the number of outlier 

payments the hospital would receive, 

and the amount of those payments. If we 

were to base final determination of 

whether the EHR payment adjustment 

should apply on meaningful use status 

during the payment year, it would be 

necessary to increase the standardized 

amount for some hospitals, that is, those 

that were assumed not to meet 

meaningful use requirements for 

purposes of making interim payments, 

but that subsequently established 

meaningful use during the payment 

year. Conversely, it would be necessary 

to decrease the standardized amount for 

those hospitals that had been assumed 

to meet meaningful use requirements for 

purposes of making interim payments, 

but that subsequently failed to meet 

those requirements during the payment 

year. In both cases, mass reprocessing of 

payments would be necessary in order 

to adjust outlier payments. Generally, 

hospitals whose standardized amounts 

are decreased at the time of final 

payment determination (due to 

application of a payment adjustment 

that was not applied to interim 

payments) would generally receive 

greater outlier payments. Conversely, 

hospitals whose standardized amounts 

are increased at the time of final 

payment determination (due to 

application of the full update that was 

not applied to interim payments) would 

generally receive lower outlier 

payments. (Reprocessing would also be 

necessary for new technology add-on 

payments, although the claims volume 

and dollar amounts involved in such 

reprocessing would be significantly 

lower.) Such reprocessing imposes 

significant costs on both the eligible 

hospital and CMS. As in the case of EPs, 

then, we continue to believe that the 

timeline we proposed is the most 

realistic approach to making payment 

adjustment determinations in an 

effective manner. 

Therefore, we are finalizing the 

proposed EHR reporting period for 

determining whether an eligible 

hospital is subject to the payment 

adjustment for CY 2015 and subsequent 

calendar years as proposed. 

c. Exception to the Application of the 

Market Basket Adjustment to Hospitals 

in FY 2015 and Subsequent FYs 

As mentioned previously, section 

1886(b)(3)(B)(ix)(II) of the Act, as 

amended by section 4102(b)(1) of the 

HITECH Act, provides that the Secretary 

may, on a case-by-case basis exempt a 

hospital from the application of the 

applicable percentage increase 

adjustment for a fiscal year if the 

Secretary determines that requiring such 

hospital to be a meaningful EHR user 

will result in a significant hardship, 

such as in the case of a hospital in a 

rural area without sufficient Internet 

access. This section also provides that 

such determinations are subject to 

annual renewal, and that in no case may 

a hospital be granted such an exception 

for more than 5 years. 

We proposed to add a new 

§ 412.64(d)(4), specifying the 

circumstances under which we will 

exempt a hospital from the application 

of the applicable percentage increase 

adjustment for a fiscal year. To be 

considered for an exception, a hospital 

must submit an application 

demonstrating that it meets one more of 

the exception criteria. 

As noted previously, the statute does 

not mandate the circumstances under 

which an exception must be granted, 

mstockstill on DSK4VPTVN1PROD with RULES2

54106 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

but (as in the case of a similar exception 

provided under the statute for EPs) it 

does state that the exception may be 

granted when ‘‘requiring such hospital 

to be a meaningful EHR user during 

such fiscal year will result in a 

significant hardship, such as in the case 

of a hospital in a rural area without 

sufficient Internet access.’’ Therefore, 

we proposed to provide in new 

§ 412.64(d)(4) that the Secretary may 

grant an exception to a hospital that is 

located in an area without sufficient 

Internet access. Furthermore, while the 

statute specifically states that such an 

exception may be granted to hospitals in 

‘‘a rural area without sufficient Internet 

access,’’ it does not require that such an 

exception be restricted only to rural 

areas without such access. While we 

believe that a lack of sufficient Internet 

access will rarely be an issue in an 

urban or suburban area, we do not 

believe that it is necessary to preclude 

the possibility that, in very rare and 

exceptional cases, a nonrural area may 

also lack sufficient Internet access to 

make complying with meaningful use 

requirements a significant hardship for 

a hospital. Therefore, we proposed that 

the Secretary may grant such an 

exception to a hospital in any area 

without sufficient Internet access. 

Because exceptions on the basis of 

insufficient Internet connectivity must 

intrinsically be considered on a case-bycase basis, we proposed to require 

hospitals to demonstrate insufficient 

Internet connectivity to qualify for the 

exception through an application 

process. The rationale for this exception 

is that lack of sufficient Internet 

connectivity renders compliance with 

the meaningful EHR use requirements a 

hardship particularly those objectives 

requiring Internet connectivity, 

summary of care documents, electronic 

prescribing, making health information 

available online, and submission of 

public health information. Therefore, 

we proposed that such an application 

must demonstrate insufficient Internet 

connectivity to comply with the 

meaningful use objectives listed 

previously and insurmountable barriers 

to obtaining such Internet connectivity 

such as high cost to build out Internet 

to their facility. As with EPs, the 

hardship would be demonstrated for 

period that is 2-years prior to the 

payment adjustment year (for example, 

FY 2013 for the payment adjustment in 

FY 2015). As with EPs, we will require 

applications to be submitted 6 months 

before the beginning of the payment 

adjustment year (that is, by April 1 

before the FY to which the adjustment 

will apply) in order to provide sufficient 

time for a determination to be made and 

for the hospital to be notified about 

whether an exception has been granted. 

This timeline for submission and 

consideration of hardship applications 

also allows for sufficient time to adjust 

our payment systems so that payment 

adjustments are not applied to hospitals 

who have received an exception for a 

specific FY. (Please also see our 

previous discussion of the parallel 

exception for EPs, with respect to 

encouraging providers to file these 

applications as early as possible, and 

the likelihood that there will not be an 

opportunity to subsequently 

demonstrate meaningful use if hospitals 

file close to or at the application 

deadline of April 1.) 

Comment: Commenters provided 

universal support for this proposed 

exception. However, some commenters 

raised concern about the situation of 

hospitals that might have Internet access 

in the 2-years prior, but lose it in the 

next year. 

Response: We are finalizing this 

exception as proposed with one 

modification. We appreciate the 

commenters’ concern about hospitals 

that might have sufficient Internet 

access in the 2 years prior to the 

adjustment period, but lose it in next 

year. We believe this is even less likely 

for hospitals than EPs, but as there is no 

downside to extending the time, we are 

finalizing a modification of our proposal 

to allow for the demonstration of 

insufficient Internet access for any 90- 

day period between the start of the year 

2 years prior to the payment adjustment 

year through the application submission 

date of April 1 of the year prior to the 

payment adjustment year. 

For the same reasons we proposed an 

exception for new EPs, we proposed an 

exception for a new hospital for a 

limited period of time after it has begun 

services. We proposed to allow new 

hospitals an exception for at least 1 full 

year cost reporting period after they 

accept their first patient. For example, a 

hospital that accepted its first patient in 

March of 2015, but with a cost reporting 

period from July 1 through June 30, 

would receive an exception from 

payment adjustment for FY 2015, as 

well as for FY 2016. However, the new 

hospital would be required to 

demonstrate meaningful use within the 

9 months of FY 2016 (register and attest 

by July 1, 2016) to avoid being subject 

to the payment adjustment in FY 2017. 

In proposing such an exception for 

new hospitals, however, we wanted to 

ensure that the exception would not be 

available to hospitals that have already 

been in operation in one form or 

another, perhaps under a different 

owner or merely in a different location, 

and thus have in fact had an 

opportunity to demonstrate meaningful 

use of EHR technology. Therefore, for 

purposes of qualifying for this 

exception, we proposed that the 

following hospitals would not be 

considered new hospitals under the 

exception: 

• A hospital that builds new or 

replacement facilities at the same or 

another location even if coincidental 

with a change of ownership, a change in 

management, or a lease arrangement. 

• A hospital that closes and 

subsequently reopens. 

• A hospital that has been in 

operation for more than 2 years but has 

participated in the Medicare program 

for less than 2 years. 

• A hospital that changes its status 

from a CAH to a hospital that is subject 

to the Medicare hospital in patient 

prospective payment systems. 

It is important to note that we 

proposed to consider a hospital that 

changes its status from a hospital (other 

than a CAH) that is excluded from the 

Medicare hospital inpatient prospective 

payment system (IPPS) to a hospital that 

is subject to the IPPS to be a new 

hospital for purposes of qualifying for 

the proposed exception. These IPPSexempt hospitals, such as long-term care 

hospitals, inpatient psychiatric 

facilities, inpatient rehabilitation 

facilities, children’s hospitals, and 

cancer hospitals, are excluded from the 

definition of ‘‘eligible hospital’’ for 

purposes of the Medicare EHR Incentive 

Program and have not necessarily had 

an opportunity to demonstrate 

meaningful use. On the other hand, 

CAHs are eligible for incentive 

payments and subject to payment 

adjustments. Under the guidelines for 

assigning CCNs to Medicare providers, a 

CAH that changes status to an IPPS 

hospital will necessarily receive a new 

CCN. This is because several digits of 

the CCN encode the provider’s status 

(for example, IPPS, CAH) under the 

Medicare program, However, we 

proposed to allow the CAH to register 

its meaningful use designation obtained 

under its previous CCN in order to 

avoid being subject to the hospital 

payment adjustment. It is worth noting 

that we adapted the proposed definition 

of ‘‘new hospital’’ for these purposes 

from similar rules that have been 

employed in the capital prospective 

payment system in § 412.300(b) of our 

regulations. We invited comment 

concerning the appropriateness of 

adapting these rules to the exception 

under the EHR program, and about 

whether modifications or other 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54107 

revisions to these rules will be 

appropriate in the EHR context. 

Comment: Several commenters 

recommended that the new hospitals 

exception for at least 1 full year cost 

reporting period be triggered not when 

the hospital accepts its first patient, but 

rather when it accepts its first Medicare 

covered patient. These commenters 

point out that there can be significant 

lapse between the time when a hospital 

accepts its first patient and the time 

when it accepts its first Medicare 

covered patient. Because the EHR 

payment adjustment applies to the 

Medicare payments, the commenters 

argued it is more appropriate to base the 

beginning of the new hospital exception 

on the admission of its first Medicare 

covered patient. 

Response: We agree with the 

commenters and are revising the new 

hospital exception in this final rule to 

run for at least one full year cost 

reporting period after the hospital 

accepts its first Medicare-covered 

patient. This change renders our third 

criterion (a hospital that has been in 

operation for more than 2 years but has 

participated in the Medicare program 

for less than 2 years) for not considering 

a hospital new moot as the exception is 

now based on the admission of the first 

Medicare-covered patient, which we 

believe is sufficiently analogous to 

starting participation in the Medicare 

program to allow us to remove this 

criterion. 

Comment: Some commenters argued 

that a hospital that undergoes a change 

of ownership and has a new CCN 

assigned due to the new owner’s 

decision not to accept the assignment of 

the prior provider agreement should be 

allowed to register its meaningful use 

designation for the old CCN in the same 

manner a CAH that becomes an 

inpatient PPS hospital would. 

Response: When a hospital has a new 

CCN assigned due to the new owner’s 

decision not to accept the assignment of 

the prior provider agreement it is not 

considered a change of ownership. 

Rather the hospital is terminated from 

the Medicare program and then 

reapplies for a new CCN. We disagree 

with the commenters that the history of 

the old CCN should carry forward in 

this case. In cases where a new owner 

decides not to accept the previous 

provider agreement and a new CCN is 

assigned by CMS, the new owner is in 

effect, making a conscious decision to 

create a rupture with significant, and 

relevant, aspects of the hospital’s 

history. Specifically, when a new owner 

acquires a Medicare participating 

hospital, CMS automatically assigns the 

provider agreement to the new owner. 

The new owner must then decide 

whether to accept or reject assignment 

of the existing agreement. If the new 

owner accepts assignment, the provider 

agreement remains intact and the owner 

retains all the benefits and liabilities of 

that agreement (as provided under 42 

CFR 489.18 of the regulations). If the 

new owner rejects assignment, the 

owner has voluntarily terminated the 

previous provider agreement, the CCN 

of the hospital is terminated, and the 

owner is not responsible for Medicare 

liabilities (known or unknown), as well 

as eligibility for Medicare payment. 

Under these circumstances, where the 

new owner has made a conscious 

decision to terminate the previous 

provider agreement, we believe it is 

appropriate not to recognize the 

meaningful use designation obtained 

under that provider agreement and CCN. 

We have consistently reminded new 

owners of hospitals that they cannot 

obtain the benefits of a decision not to 

accept assignment of the provider 

agreement without accepting the 

burdens of the decision as well. Unlike 

the case of a CAH that becomes an 

inpatient PPS hospital, the assignment 

of a new CCN follows from a voluntary 

decision of the new owner not to retain 

the previous provider agreement and 

CCN. 

We believe a similar result should 

apply in other cases where acquisitions 

and/or combinations of hospitals lead to 

the discontinuation of a CCN under 

which meaningful use had been 

demonstrated. For example, in some 

cases there is a combination of two or 

more certified hospitals under one 

agreement and one CCN. If the 

combined hospital has multiple 

locations, one location becomes the 

‘‘main location,’’ and all other locations 

become remote and/or provider based. 

The hospital is considered ‘‘one 

hospital’’ by Medicare and must be truly 

integrated at all levels, including its 

system for maintaining medical records. 

Where the new owner rejects the 

assignment of the provider agreement 

for one or more of the facilities that are 

being combined into the integrated 

hospital, known and unknown Medicare 

liabilities of those facilities do not 

transfer to the new owner. Under these 

circumstances, for the same reasons 

discussed in the previous case, it is 

appropriate not to recognize the 

meaningful use designation that was 

obtained under the provider 

agreement(s) and CCN(s) that have not 

been retained under the integrated 

hospital. 

Even where the new owners retain the 

acquired hospital’s Medicare provider 

agreement, the acquired hospital’s 

agreement is subsumed (although not 

terminated) into the single provider 

agreement of the combined hospital, 

and the acquired hospital’s CCN is 

retired (again, not terminated). The new 

owners are responsible for all known 

and unknown Medicare liabilities of 

previous owners of the hospital, and 

there is no break in Medicare payments, 

as is the case where assignment of the 

prior provider agreement is rejected. 

However, as noted previously, in these 

cases, if the combined hospital has 

multiple locations, one location 

becomes the ‘‘main location,’’ and all 

other locations become remote and/or 

provider based. The hospital is 

considered ‘‘one hospital’’ by Medicare 

and must be truly integrated at all 

levels. In these cases it is most 

appropriate to recognize the prior 

meaningful use status of the surviving 

CCN of the main location for purposes 

of determining whether the payment 

penalty applies to the newly integrated 

hospital. In that way, the meaningful 

use determination will be based on the 

prior status of the major portion of the 

newly integrated hospital. Otherwise, 

the meaningful use designation of a 

relatively minor remote and/or 

provider-based hospital may become the 

basis for the designation of a much 

larger combined and integrated hospital. 

Therefore, we are finalizing our 

proposed policy, in cases of various 

ownership changes, acquisitions, and 

combinations of hospitals, to employ 

the meaningful use status of the 

surviving CCN to determine whether the 

payment adjustment applies. 

Finally, we proposed an additional 

exception in this final rule for extreme 

circumstances that make it impossible 

for a hospital to demonstrate meaningful 

use requirements through no fault of its 

own during the reporting period. Such 

circumstances might include: A hospital 

closed; a natural disaster in which an 

EHR system is destroyed; EHR vendor 

going out of business; and similar 

circumstances. Because exceptions on 

extreme, uncontrollable circumstances 

must be evaluated on a case-by-case 

basis, we believe that it is appropriate 

to require hospitals to qualify for the 

exception through an application 

process. 

Comment: Commenters stated 

universal support for this exception. 

However many commenters requested 

various circumstances be added to the 

list of example circumstances. This list 

is very similar, but not entirely identical 

to that for EPs. These examples dealt 

primarily with concerns related to 

vendors of CEHRT. Specifically, 

commenters were concerned about 

vendors of CEHRT not maintaining their 

mstockstill on DSK4VPTVN1PROD with RULES2

54108 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

certification status, ability to meet 

implementation schedules, and ability 

to find a vendor of CEHRT willing to 

work with them. In addition, 

commenters suggested that the provider 

facing severe financial distress, such as 

bankruptcy or restructuring of debt 

should be included as an example. 

Response: We used the same 

evaluation criteria we used for EPs and 

came to the same conclusion to add two 

examples to the list that was proposed: 

(1) A hospital whose CEHRT (complete 

or modular) loses its certification either 

through revocation or because the 

vendor did not upgrade their CEHRT to 

the latest requirements; and (2) a 

hospital suffering severe financial 

distress resulting in a bankruptcy or 

restructuring of debt. 

We will require applications to be 

submitted no later than April 1 of the 

year before the payment adjustment year 

in order to provide sufficient time for a 

determination to be made and for the 

hospital to be notified about whether an 

exception has been granted prior to the 

payment adjustment year. This timeline 

for submission and consideration of 

hardship applications also allows for 

sufficient time to adjust our payment 

systems so that payment adjustments 

are not applied to hospitals who have 

received an exception for a specific 

payment adjustment year. As discussed 

earlier, in relation to EPs, in order for a 

hospital to apply for this exception, 

extreme circumstances would need to 

exist for the period in which the 

hospital would otherwise demonstrate 

meaningful use (that is, the EHR 

reporting period). We have modified our 

regulation to be clear that the 

circumstances must exist during the 

EHR reporting period (that is, 2 years 

prior to the payment adjustment year or, 

for hospitals that have never attested to 

meaningful use before, in the year 

immediately prior to the payment 

adjustment year). 

Comment: Commenters suggested the 

following additional exceptions: 

• Hospitals who make a good faith 

effort to purchase CEHRT, but could not 

find a vendor willing to work with 

them. 

• Hospitals that determine they must 

switch EHR vendors to achieve 

meaningful use. 

• Hospitals unable to meet 

meaningful use requirements because of 

failures on the part of EHR vendors. 

Response: For the first suggested 

exception, we do not believe that 

hospitals that attempt to purchase 

CEHRT but cannot find a vendor would 

warrant an exception. The mere failure 

of an attempt to purchase CEHRT does 

not demonstrate that the hospital faces 

hardship significant enough to prevent 

it from becoming a meaningful EHR 

user. We also believe it would be 

problematic to define the parameters for 

determining that no vendor was willing 

to work with a hospital. Moreover, we 

already have provided for an exception 

for hospitals that face extreme 

circumstances beyond their control. 

Under this exception, eligible hospitals 

could attempt to show that their 

situation is extreme and out of the 

ordinary and that failure to obtain 

CEHRT was truly beyond their control. 

We are skeptical that such showings 

could be made when all the hospital has 

done is to make an attempt to purchase 

CEHRT. However, this exception 

provides hospitals with the opportunity 

to demonstrate that their failure of 

attempts to obtain CEHRT was due to 

circumstances beyond their control. 

The next two exceptions may fall 

under the exception for extreme 

circumstances beyond the hospital’s 

control, but the hospital would need to 

demonstrate that it meets this extreme 

exception. Any determination would be 

highly dependent on individual 

circumstances and evaluation of 

whether it is truly necessary to switch 

vendors, whether the switching vendors 

would prevent the hospital from 

reaching meaningful use, and whether 

the ‘‘failures’’ of the EHR vendor are 

both outside the norm of EHR 

implementation and beyond the control 

of the hospital. 

Table 16 summarizes the timeline for 

hospitals to avoid the applicable 

payment adjustment by demonstrating 

meaningful use or qualifying for an 

exception from the application of the 

adjustment. 

TABLE 16—TIMELINE FOR ELIGIBLE HOSPITALS TO AVOID PAYMENT ADJUSTMENT

Hospital 

payment adjustment year 

(fiscal year) 

Demonstrate MU during EHR 

reporting period 2 years prior to year of 

payment adjustment 

Or 

For an eligible hospital demonstrating 

meaningful use for the first time in the 

year prior to the payment adjustment year 

use a continuous 90-day reporting period 

beginning no later than: 

Or 

Apply for an 

exception no later 

than: 

2015 .................. FY 2013 (with submission no later than 

November 30, 2013 ).

April 2, 2014 (with submission no later 

than July 1, 2014).

April 1, 2014. 

2016 .................. FY 2014 (with submission no later than 

November 30, 2014).

April 2, 2015 (with submission no later 

than July 1, 2015).

April 1, 2015. 

2017 .................. FY 2015 (with submission no later than 

November 30, 2015).

April 2, 2016 (with submission no later 

than July 1, 2016).

April 1, 2016. 

2018 .................. FY 2016 (with submission no later than 

November 30, 2016).

April 2, 2017 (with submission no later 

than July 1, 2017).

April 1, 2017. 

2019 .................. FY 2017 (with submission no later than 

November 30, 2017).

April 2, 2018 (with submission no later 

than July 1, 2014).

April 1, 2018. 

Notes: (FY refers to the Federal fiscal year: October 1 to September 30. For example, FY 2015 is October 1, 2014 through September 30,

2015.) 

The timelines for FY 2020 and subsequent fiscal years follow the same pattern. 

TABLE 17—PERIOD HARDSHIP MUST BE SHOWN WITH APPLICATION DATE

Exception Period of consideration for exception Submit application for FY 2015 no 

later than 

Insufficient Internet access ............. Demonstrate insufficient Internet access for any 90 days from the 

start of the FY 2 years prior to the payment adjustment year to 

April 1 of the year prior to the payment adjustment year (For FY 

2015–October 1, 2012–April 1, 2014).

April 1, 2014. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54109 

TABLE 17—PERIOD HARDSHIP MUST BE SHOWN WITH APPLICATION DATE—Continued 

Exception Period of consideration for exception Submit application for FY 2015 no 

later than 

New hospital .................................... New hospital granted an exception for one full cost reporting period 

after they admit their first Medicare patient.

Guidance to be issued following 

publication of the final rule. 

Extreme Circumstances outside of 

the hospital’s Control.

For a hospital that has previously demonstrated meaningful use, the 

hospital must demonstrate extreme circumstances that affect the 

FY 2 years prior to the payment adjustment year. (For FY 2015–FY 

2013).

For a hospital that has never demonstrated meaningful use, the hospital must demonstrate extreme circumstances that affect the FY 

prior to the payment adjustment year. (For FY 2015–FY 2014).

April 1, 2014. 

d. Application of Market Basket 

Adjustment in FY 2015 and Subsequent 

FYs to a State Operating Under a 

Payment Waiver Provided by Section 

1814(b)(3) of the Act 

As discussed previously, the statute 

requires payment adjustments for 

eligible hospitals in states where 

hospitals are paid under section 

1814(b)(3) of the Act. The statute also 

requires such adjustments to be 

designed to result in an aggregate 

reduction in payments equivalent to the 

aggregate reduction that would have 

occurred if payments had been reduced 

under section 1886(b)(3)(B)(ix)(I) of the 

Act. We proposed that an aggregate 

reduction in payments would mean the 

same dollar amount in reduced 

Medicare payments that that would 

have occurred if payments had been 

reduced to each eligible hospital in the 

state in a manner comparable to the 

reduction under § 412.64(d)(3). 

To implement this provision, we 

proposed a new § 412.64(d)(5) that 

includes this statutory requirement and 

that required states operating under a 

payment waiver under section 

1814(b)(3) of the Act to provide to the 

Secretary, no later than January 1, 2013, 

a report on the method that it proposes 

to employ in order to make the requisite 

payment adjustment. 

We did not receive any comments on 

this proposal; and therefore, we are 

finalizing these provisions as proposed. 

4. Reduction of Reasonable Cost 

Reimbursement in FY 2015 and 

Subsequent Years for CAHs That Are 

Not Meaningful EHR Users 

Section 4102(b)(2) of the HITECH Act 

amends section 1814(l) of the Act to 

include an adjustment to a CAH’s 

Medicare reimbursement for inpatient 

services if the CAH has not met the 

meaningful EHR user definition for an 

EHR reporting period. The adjustment 

will be made for a cost reporting period 

that begins in FY 2015, FY 2016, FY 

2017, and each subsequent FY 

thereafter. Specifically, sections 

1814(l)(4)(A) and (B) of the Act now 

provide that, if a CAH has not 

demonstrated meaningful use of CEHRT 

for an applicable reporting period, then 

for a cost reporting period that begins in 

FY 2015, its reimbursement will be 

reduced from 101 percent of its 

reasonable costs to 100.66 percent. For 

a cost reporting period beginning in FY 

2016, its reimbursement will be reduced 

to 100.33 percent of its reasonable costs. 

For a cost reporting period beginning in 

FY 2017 and each subsequent FY, its 

reimbursement will be reduced to 100 

percent of reasonable costs. 

However, as provided for eligible 

hospitals, a CAH may, on a case-by-case 

basis, be granted an exception from this 

adjustment if CMS or its Medicare 

contractor determines, on an annual 

basis, that a significant hardship exists, 

such as in the case of a CAH in a rural 

area without sufficient Internet access. 

However, in no case may a CAH be 

granted an exception under this 

provision for more than 5 years. 

a. Applicable Reduction of Reasonable 

Cost Payment Reduction in FY 2015 and 

Subsequent Years for CAHs That Are 

Not Meaningful EHR Users 

In the Stage 1 final rule (75 FR 44564), 

we finalized the regulations regarding 

the CAH adjustment at § 495.106(e) and 

§ 413.70(a)(6). 

b. EHR Reporting Period for 

Determining Whether a CAH Is Subject 

to the Applicable Reduction of 

Reasonable Cost Payment in FY 2015 

and Subsequent Years 

For CAHs we proposed an EHR 

reporting period that is aligned with the 

payment adjustment year. For example, 

if a CAH is not a meaningful EHR user 

in FY 2015, then its Medicare 

reimbursement will be reduced to 

100.66 percent for its cost reporting 

period that begins in FY 2015. This 

differs from what was proposed for 

eligible hospitals: an EHR reporting 

period prior to the payment adjustment 

year. We stated in the proposed rule that 

we believed the Medicare cost report 

process would allow us to make the 

CAH reduction for the cost reporting 

period that begins in the payment 

adjustment year, with minimal 

disruptions to the CAH’s cash flow and 

minimal administrative burden on the 

Medicare contractors as discussed later. 

CAHs are required to file an annual 

Medicare cost report that is typically for 

a consecutive 12-month period. The cost 

report reflects the inpatient statistical 

and financial data that forms the basis 

of the CAH’s Medicare reimbursement. 

Interim Medicare payments may be 

made to the CAH during the cost 

reporting period based on the previous 

year’s data. Cost reports are filed with 

the CAH’s Medicare contractor after the 

close of the cost reporting period and 

the data on the cost report are subject to 

reconciliation and a settlement process 

prior to a final Medicare payment being 

made. 

We proposed to amend the definition 

of the EHR reporting period that will 

apply for purposes of payment 

adjustments under § 495.4. For CAHs 

this will be the full Federal fiscal year 

that is the same as the payment 

adjustment year (unless a CAH is in its 

first year of demonstrating meaningful 

use, in which case a continuous 90-day 

reporting period within the payment 

adjustment year will apply). The 

adjustment would then apply based 

upon the cost reporting period that 

begins in the payment adjustment year 

(that is, FY 2015 and thereafter). Thus, 

if a CAH is not a meaningful user for FY 

2015, and thereafter, then the 

adjustment would be applied to the 

CAH’s reasonable costs incurred in a 

cost reporting period that begins in that 

affected FY as described in 

§ 413.70(a)(6)(i). 

We proposed to require CAHs to 

submit their attestations on meaningful 

use by November 30th of the following 

FY. For example, if a CAH is attesting 

that it was a meaningful EHR user for 

FY 2015, the attestation must be 

submitted no later than November 30, 

2015. Such an attestation (or lack 

mstockstill on DSK4VPTVN1PROD with RULES2

54110 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

thereof) will then affect interim 

payments to the CAH made after 

December 1st of the applicable FY. If the 

cost reporting period ends prior to 

December 1st of the applicable FY then 

any applicable payment adjustment will 

be made through the cost report 

settlement process. 

All comments received on this 

provision were in support. We thank 

commenters for their support and 

finalize as proposed for the reasons 

outlined in the proposed rule. 

c. Exception to the Application of 

Reasonable Cost Payment Reductions to 

CAHs in FY 2015 and Subsequent FYs 

As discussed previously, CAHs may 

receive exceptions from the payment 

adjustments for significant hardship. 

While our current regulations, in 

§ 413.70(a)(6)(ii) and (iii) contain this 

hardship provision we proposed 

revising these regulations to align them 

with the exceptions being proposed for 

EPs and subsection (d) hospitals. As 

with EPs and subsection (d) hospitals 

we proposed that CAHs could apply for 

an exception on the basis of lack of 

sufficient Internet connectivity. 

Applications will be required to 

demonstrate insufficient Internet 

connectivity to comply with the 

meaningful use objectives requiring 

internet connectivity (that is, summary 

of care documents, electronic 

prescribing, making health information 

available online, and submission of 

public health information) and 

insurmountable barriers to obtaining 

such internet connectivity. As CAHs 

will have an EHR reporting period 

aligned with the payment adjustment 

year, we proposed that the insufficient 

Internet connectivity will need to be 

demonstrated for each applicable 

payment adjustment year. For example, 

as proposed, to avoid a payment 

adjustment for cost reporting periods 

that begin during FY 2015, the hardship 

would need to be demonstrated for FY 

2015. For each year subsequent to FY 

2015, the basis for an exception would 

continue to be for the hardship in the 

FY in which the affected cost reporting 

period begins. As stated in 

§ 413.70(a)(6)(iii), any exception granted 

may not exceed 5 years. After 5 years, 

the exception will expire and the 

appropriate adjustment will apply if the 

CAH has not become a meaningful EHR 

user for the appropriate EHR reporting 

period. 

Comment: Commenters have 

suggested that it is inappropriate to base 

the Internet connectivity exception on 

the same year that a CAH is expected to 

demonstrate meaningful use. They 

assert that it is impractical for a CAH to 

achieve sufficient internet connectivity 

and meet meaningful use all in 1 year. 

A few commenters recommended a 2- 

year prospective exception for Internet 

connectivity as used for the EPs and 

inpatient PPS hospitals. 

Response: We agree with commenters 

that established sufficient Internet 

connectivity and meaningful use in the 

same year is not feasible. However, 

since the payment adjustment year is 

aligned with the CAH’s EHR period, we 

believe that using a 2-year lookback 

period similar to EPs and eligible 

hospitals is inappropriate for CAHs. 

Therefore, we will base the insufficient 

internet access exception on the cost 

reporting period that begins prior to or 

during the payment adjustment year. 

For FY 2015, the CAH must submit the 

application by November 30, 2015, but 

eligibility for this exception would be 

based on the information for any 90-day 

period within the cost reporting period 

that begins prior to or during the 

payment adjustment year. 

After consideration of the comments, 

we are revising this exception to base it 

on any 90-day period within the cost 

reporting period that begins prior to or 

during the payment adjustment year. 

As with new EPs and new eligible 

hospitals, we proposed an exception for 

a new CAH for a limited period of time 

after it has begun services. We proposed 

to allow an exception for 1 year after 

they accept their first patient. For 

example, a CAH that is established in 

FY 2015 would be exempt from the 

penalty through its cost reporting period 

ending at least 1 year after the CAH 

accepts its first patient. If the CAH is 

established March 15, 2015 and its first 

cost reporting period is less than 12 

months (for example, from March 15 

through June 30, 2015), the exception 

would exist for both the short cost 

reporting period and the following 12- 

month cost reporting period lasting from 

July 1, 2015 through June 30, 2016. 

However, the new CAH would be 

required to submit its attestation that it 

was a meaningful EHR user for FY 2016 

no later than November 30, 2016, in 

order to avoid being subject to the 

payment adjustment for the cost 

reporting period that begins in FY 2016 

(in the previous example from July 1, 

2016 through June 30, 2017). 

We stated in the proposed rule that in 

proposing such an exception for newly 

established CAHs, it is important to 

ensure that the exception is not 

available to CAHs that have already 

been in operation in one form or 

another, perhaps under a different 

ownership or merely in a different 

location, and thus have in fact had an 

opportunity to demonstrate meaningful 

use of EHR technology. Therefore, we 

proposed that for the purposes of 

qualifying for this exception, a new 

CAH means a CAH that has operated 

(under previous or present ownership) 

for less than 1 year. 

We stated in the proposed rule that in 

some cases an eligible hospital may 

convert to a CAH. An eligible hospital 

is a subsection (d) hospital that is a 

meaningful user and is paid under the 

inpatient hospital prospective payment 

systems as described in subpart A of 

Part 412 of the regulations. In these 

cases, eligible hospitals were able to 

qualify for purposes of the EHR hospital 

incentive payments by establishing 

meaningful use, and (as discussed 

previously) are also subject to a 

payment adjustment provision in FY 

2015 and subsequent years if they fail to 

demonstrate meaningful use of EHR 

technology during an applicable 

reporting period. Therefore, we 

proposed not to treat a CAH that has 

converted from an eligible hospital as a 

newly established CAH for the purposes 

of this exception. 

On the other hand, we stated in the 

proposed rule that other types of 

hospitals such as long-term care 

hospitals, psychiatric hospitals, and 

inpatient rehabilitation facilities are not 

subsection (d) hospitals. These other 

types of hospitals do not meet the 

definition of an ‘‘eligible hospital’’ for 

purposes of the Medicare EHR hospital 

incentive payments and the application 

of the proposed hospital market basket 

adjustment in FY 2015 and subsequent 

years under section 1886(n)(6)(B) of the 

Act. In some instances, a CAH may be 

converted from one of these types of 

hospitals. In that case, the CAH would 

not have had an opportunity to 

demonstrate meaningful use, and it is 

therefore appropriate to treat them as 

newly established CAHs if they convert 

from one of these other types of 

hospitals to a CAH for purposes of 

determining whether they should 

qualify for an exception from the 

application of the adjustment in FY 

2015 and subsequent years. Thus, we 

proposed to consider a CAH that 

converts from one of these other types 

of hospitals to be a newly established 

CAH for the purposes of qualifying for 

this proposed exception from the 

application of the adjustment in FY 

2015 and subsequent years. 

In summary, we proposed for 

purposes of qualifying for the exception 

to revise § 413.70(a)(6)(ii) to state that a 

newly established CAH means a CAH 

that has operated (under previous or 

present ownership) for less than 1 year. 

We also proposed to revise 

§ 413.70(a)(6)(ii) to state that the 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54111 

following CAHs are not newly 

established CAHs for purposes of this 

exception: 

• A CAH that builds new or 

replacement facilities at the same or 

another location even if coincidental 

with a change of ownership, a change in 

management, or a lease arrangement. 

• A CAH that closes and 

subsequently reopens. 

• A CAH that has been in operation 

for more than 1 year but has 

participated in the Medicare program 

for less than 1 year. 

• A CAH that has been converted 

from an eligible subsection (d) hospital. 

Comment: Identical to the concerns 

raised for subsection (d) hospitals, 

several comments stated that the new 

CAH exception for at least 1 full year 

cost reporting period be triggered not by 

when the hospital accepts its first 

patient, but rather when it accepts its 

first Medicare-covered patient. 

Response: We agree with the 

commenters and revise the exception for 

new CAHs to be for at least 1 full year 

cost reporting period after they accept 

their first Medicare-covered patient. 

This change renders our third criteria (a 

CAH that has been in operation for more 

than 2 years but has participated in the 

Medicare program for less than 2 years) 

for not considering a CAH new moot as 

the exception is now based on the 

admission of the first Medicare-covered 

patient, which we believe is sufficiently 

analogous to starting participation in the 

Medicare program to allow us to remove 

this criteria. 

After consideration of comments, we 

are revising this exception to base it on 

the point when the CAH accepts their 

first Medicare patient. 

Finally, we proposed an additional 

exception in this final rule for extreme 

circumstances that make it impossible 

for a CAH to demonstrate meaningful 

use requirements through no fault of its 

own during the reporting period. Such 

circumstances might include: A CAH is 

closed; a natural disaster in which an 

EHR system is destroyed; EHR vendor 

going out of business; and similar 

circumstances. Because exceptions on 

extreme, uncontrollable circumstances 

must be evaluated on a case-by-case 

basis, we believe that it is appropriate 

to require CAHs to qualify for the 

exception through an application 

process. 

Comment: Commenters supported 

this exception in principle. However, 

many commenters requested various 

circumstances be added to the list of 

example circumstances. This list is 

nearly entirely identical to that for EPs 

and subsection (d) hospitals as 

described earlier. 

Response: We used the same 

evaluation criteria we used for EPs and 

came to the same conclusion to add two 

examples. First, a CAH whose CEHRT 

(complete or modular) loses its 

certification either through revocation 

or because the vendor did not upgrade 

their CEHRT to the latest requirements; 

and second, a CAH suffering severe 

financial distress resulting in a 

bankruptcy or restructuring of debt 

As described previously, we are 

finalizing the policy to align a CAH’s 

payment adjustment year with the 

applicable EHR reporting period. A 

CAH must submit their meaningful use 

attestation for a specific EHR reporting 

period no later than 60 days after the 

close of the EHR reporting period (no 

later than November 30th of the year) 

otherwise the payment penalty could be 

applied to the CAH’s cost reporting 

period that begins in that payment 

adjustment year. We proposed to require 

a CAH to submit an application for an 

exception, as described previously, to 

its Medicare contractor by the same 

November 30th date that the meaningful 

use attestation is due. Therefore, we 

proposed that a CAH will be subject to 

the payment adjustment if it has not 

submitted its meaningful use attestation 

(or its attestation has been denied) and 

has not submitted an application for an 

exception by November 30th of the 

subsequent EHR reporting period. If a 

CAH’s request for an exception is not 

granted by the Medicare contractor then 

we proposed that the payment 

adjustment will be applied. We stated in 

the proposed rule that if a CAH 

anticipates submitting an exception 

application we recommend that the 

CAH communicate with its Medicare 

contractor to determine the necessary 

supporting documentation to submit by 

the November 30th due date. 

After consideration of public 

comments, we are finalizing these 

application deadlines exception as 

proposed. 

Table 18, summarizes the timeline for 

CAHs to avoid the applicable payment 

adjustment by demonstrating 

meaningful use or qualifying for an 

exception from the application of the 

adjustment. 

Comment: Commenters provided the 

same suggestions for additional 

exceptions for CAHs that they did for 

eligible hospitals. 

Response: As we stated in our 

response to similar comments submitted 

for eligible hospitals these additional 

exceptions could have been suggested as 

examples for the exception for extreme 

circumstances. We encourage hospitals 

in these situations to utilize the extreme 

circumstances exception. We believe 

these exceptions are too subjective to be 

finalized as new exceptions as suggested 

by commenters. 

TABLE 18—TIMELINE FOR CAHS TO AVOID PAYMENT ADJUSTMENT

CAH with cost 

reporting period 

beginning during 

payment 

adjustment year 

Demonstrate MU for EHR 

reporting period Or 

For a CAH demonstrating MU for the first 

time, a continuous 90-day reporting 

period ending no later than 

Or Apply for an exception 

no later than 

FY 2015 ............ FY 2015 (with submission no later than 

November 30, 2015).

September 30, 2015 (with submission no 

later than November 30, 2015).

November 30, 2015. 

FY 2016 ............ FY 2016 (with submission no later than 

November 30, 2016).

September 30, 2016 (with submission no 

later than November 30, 2016).

November 30, 2016. 

FY 2017 ............ FY 2017 (with submission no later than 

November 30, 2017).

September 30, 2017 (with submission no 

later than November 30, 2017).

November 30, 2017. 

FY 2018 ............ FY 2018 (with submission no later than 

November 30, 2018).

September 30, 2018 (with submission no 

later than November 30, 2018).

November 30, 2018. 

FY 2019 ............ FY 2019 (with submission no later than 

November 30, 2019).

September 30, 2019 (with submission no 

later than November 30, 2019).

November 30, 2019. 

Notes: (FY refers to the Federal fiscal year October 1 to September 30. For example, FY 2015 is October 1, 2014 to September 30, 2015.) 

The timelines for FY 2020 and subsequent fiscal years follow the same pattern. 

mstockstill on DSK4VPTVN1PROD with RULES2

54112 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 19—PERIOD HARDSHIP MUST BE SHOWN WITH APPLICATION DATE FOR CAHS

Exception Period of consideration for exception Submit application for FY 2015 no 

later than 

Insufficient Internet access—CAHs Demonstrate insufficient internet access for any 90 day period within 

the cost reporting period that begins prior to or during the payment 

adjustment year.

Nov 30, 2015. 

New CAHl ........................................ New CAH granted an exception for one full cost reporting period after 

they admit their first Medicare patient.

Guidance to be issued following 

publication of the final rule. 

Extreme Circumstances outside of 

the CAH’s Control.

Oct 1 through Sept 30 of the payment adjustment year ....................... Nov 30, 2015. 

5. Administrative Review Process of 

Certain Electronic Health Record 

Incentive Program Determinations 

In the Stage 2 proposed rule we 

proposed an administrative appeals 

process would apply to both Stage 1 and 

Stage 2 of meaningful use. We also 

posted guidance on the CMS Web site, 

http://www.cms.gov/qualitymeasures/

05_ehrincentiveprogramappeals.asp, in 

the interim between the publication of 

this proposed rule and the publication 

of the final rule. We sought public 

comments both on the guidance and the 

proposed rule. 

We proposed to limit permissible 

appeals to the following three types of 

appeals: 

• Eligibility Appeals 

• Meaningful Use Appeals 

• Incentive Payment Appeals 

We also proposed certain filing and 

other deadlines for such administrative 

appeals. We refer readers to our 

proposed rule at (77 FR 13779 through 

13780) for a full explanation of these 

proposals. 

We received several comments on our 

appeals proposals, which are discussed 

in this section of the preamble. 

However, after review of the public 

comments and the appeals filed as of 

the writing of this final rule, we believe 

the administrative review process is 

primarily procedural and does not need 

to be specified in regulation. The 

appeals process we proposed essentially 

constituted an agency reconsideration of 

certain types of determinations 

regarding eligibility for the program, 

meaningful use, or incentive payment 

amounts. We believe such an informal 

reconsideration process may be 

included in procedural guidance, rather 

than in our regulations. Therefore, our 

administrative appeals process will be 

included on our Web site at www.cms.

gov/EHRIncentivePrograms. 

We recognize that there is a 

procedural appeals process currently in 

effect, and in all cases, we will require 

that requests for appeals, all filings, and 

all supporting documentation and data 

be submitted through a mechanism and 

in a manner specified by us. We expect 

all providers to exhaust this 

administrative review process prior to 

seeking review in Federal Court. 

As we stated in the proposed rule, we 

also note that the HITECH Act prohibits 

both administrative and judicial review 

of the standards and method used to 

determine eligibility and payment 

(including those governing meaningful 

use) (see 42 CFR 413.70(a)(7), 

495.106(f), 495.110, 495.212). Our 

limited appeal process would not 

provide administrative review of these 

areas; but rather would involve cases of 

individual applicability; that is, where a 

provider is challenging not the 

standards and methods themselves, but 

whether the provider met the regulatory 

standards and methods promulgated by 

CMS in its rules. 

While we are not finalizing 

regulations on appeals, we respond to 

comments we received on our 

proposals. 

Comment: Several commenters 

requested CMS make more explicit 

information available to providers on 

the documentation that should be 

available in the event of an audit. 

Response: In the event of an audit, at 

a minimum, providers should have 

available electronic or paper 

documentation that supports providers’ 

completion of the Attestation Module 

responses, including the specific 

information that supports each measure. 

In addition, providers should have 

documentation to support the 

submission of CQMs, including the 

specific information that supports each 

measure. Providers should also 

maintain documentation to support 

their incentive payment calculations, for 

example data to support amounts 

included on their cost report, which are 

used in the calculation. As indicated in 

the Stage 1 final rule, providers should 

keep documentation for at least 6 years 

following the date of attestation. 

Comment: A commenter noted that 

states may need to change their audit 

procedures or State Medicaid Health 

Information Technology (HIT) Plans 

(SMHPs) regarding audit and appeals by 

CMS for demonstrating meaningful use. 

Response: We proposed that states 

would have an option to have CMS 

audit and conduct appeals of eligible 

hospitals’ meaningful use. We finalize 

that proposal in our Medicaid 

regulations at § 495.332. We agree that 

SMHPs regarding audit and appeals may 

need revising. We are working closely 

with states to align principles regarding 

both audit and appeals process for both 

the Medicare and Medicaid EHR 

Incentive Programs. We intend to give 

states both technical support and 

program information to ensure 

consistency in the application of those 

audit and appeals principles. 

Comment: A number of commenters 

asked for the addition of appeal 

categories beyond those we proposed. 

Several commenters requested CMS 

implement an appeals process for 

penalties and hardship exemptions. One 

commenter requested more 

comprehensive language to better define 

the requirements and circumstances 

under which appeals may be heard and 

acted upon. Another commenter 

requested CMS institute an appeals 

process relating to MACs’ decisions 

regarding reasonable costs and 

determining incentive payments for 

CAHs. 

Response: We appreciate the number 

of commenters that requested additional 

appeal categories. Since the writing and 

publication of the Stage 1 final rule, we 

have had the opportunity to review a 

number of appeals, and we note that 

many of these appeals do not 

necessarily fit easily into the categories 

we proposed. Based on the comments 

we received and the information we 

have regarding appeals that have 

already been filed, we are concerned 

that finalizing the categories we 

proposed for appeals could negatively 

impact providers and potentially add 

unnecessary burden and complexity. 

We are also concerned that specifying 

these categories could limit the 

flexibility we might otherwise have in 

addressing new or unanticipated appeal 

categories in the future, or in adding 

greater detail regarding the scope and 

requirements of particular types of 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54113 

appeals. For example, a number of the 

appeals we have received are related 

neither to eligibility, meaningful use, or 

incentive payments directly, but instead 

address registration or attestation 

system changes that we are currently in 

the process of implementing for 

providers’ benefit. Because of these 

concerns, we decline to finalize the 

categories of appeals as proposed and 

intend to issue guidance regarding types 

or categories of appeals and 

accompanying requirements on our Web 

site at www.cms.gov/ 

EHRIncentivePrograms. 

As stated earlier, the HITECH Act 

prohibits both administrative and 

judicial review of the standards and 

methods used to determine eligibility 

and payment (including those governing 

meaningful use) (see 42 CFR 

413.70(a)(7), 495.106(f), 495.110, 

495.212). Any procedures would not 

allow administrative appeals of these 

issues. As for reasonable costs reported 

by CAHs, we already stated in the Stage 

1 final rule that a CAH ‘‘may appeal the 

statistical and financial amounts from 

the Medicare cost report used to 

determine the CAH incentive payment,’’ 

but that the CAH ‘‘would utilize the 

current provider appeal process 

pursuant to section 1878 of the Act.’’ (75 

FR 44464) 

Finally, we note that there will not be 

appeal reconsiderations of hardship 

exception or payment adjustment 

determinations. As specified in section 

II.D.2.c. of this final rule, the granting of 

a hardship exception will be through an 

application process, and we expect 

providers to make a full declaration of 

all relevant information at the time of 

filing of that application. We are 

concerned that there would not be 

adequate time to process hardship 

exception applications, render 

determinations, and also process 

appeals of those redeterminations. 

Therefore, we decline to allow appeal 

reconsiderations of hardship exception 

determinations. We note that the 

HITECH Act prohibits both 

administrative and judicial review of 

the standards and methods used to 

determine payment adjustments, 

including hardship exceptions to those 

payment adjustments. 

Comment: A number of commenters 

noted concerns regarding the timelines 

proposed for filing appeals and 

forwarding documentation. 

Response: We appreciate the many 

comments regarding the proposed 

timelines for appeals. However, we are 

not finalizing our appeal regulations in 

this final rule. We intend to issue 

guidance regarding timelines for types 

or categories of appeals on our Web site 

at www.cms.gov/EHRIncentivePrograms. 

E. Medicare Advantage Organization 

Incentive Payments 

1. Definitions (§ 495.200) 

We proposed to add definitions of the 

terms ‘‘Adverse eligibility 

determination,’’ ‘‘Adverse payment 

determination’’ and ‘‘MA payment 

adjustment year.’’ We also proposed to 

add a definition for the term 

‘‘Potentially qualifying MA–EPs and 

potentially qualifying MA-affiliated 

eligible hospitals,’’ to cross reference the 

existing definition at § 495.202(a)(4). 

We proposed to clarify the application 

of ‘‘hospital-based EP’’ as that term is 

used in paragraph 5 of the definition of 

‘‘qualifying MA–EP’’ in § 495.200, to 

make clear that the calculation is not 

based on FFS-covered professional 

services, but rather on MA plan 

enrollees. Otherwise, qualifying MA– 

EPs who provide at least 80 percent of 

their covered professional services to 

MA plan enrollees of a qualifying MA 

organization might be considered 

‘‘hospital based’’ solely on the basis of 

90 percent of their FFS-covered 

professional services being provided in 

a hospital setting. We provided an 

example of a qualifying MA–EP that 

might bill FFS 10 times over a year for 

emergency room services provided to 

various Medicare patients. Although the 

vast majority of the MA–EP’s covered 

services were reimbursed under his or 

her arrangement with a qualifying MA 

organization, 100 percent (or 10) of the 

MA–EP’s FFS-covered services would 

have been for hospital-based services, 

which would prohibit the MA 

organization from receiving 

reimbursement under the MA EHR 

incentive program for the MA–EP. We 

do not believe that we should exclude 

MA–EPs from the MA EHR Incentive 

Program due to only a few FFS claims. 

Therefore, we are clarifying the 

definition of ‘‘qualifying MA–EP’’ to 

state that for purposes of the MA EHR 

Incentive Program, a hospital-based 

MA–EP provides 90 percent or more of 

his or her covered professional services 

in a hospital setting to MA plan 

enrollees of the qualifying MA 

organization. 

We did not receive any comments on 

these provisions and we are finalizing 

them as proposed with the exception of 

the definitions of the terms ‘‘Adverse 

eligibility determination,’’ and ‘‘Adverse 

payment determination.’’ As we explain 

later in this preamble discussion, we do 

not believe formal regulations for an 

informal reconsideration procedural 

rule are necessary and therefore, we are 

not finalizing these two definitions in 

our regulations. 

2. Identification of Qualifying MA 

Organizations, MA–EPs, and MAAffiliated Eligible Hospitals (§ 495.202) 

We proposed a technical change to 

§ 495.202(b)(1) to require that the 

qualifying MA organization identify 

those MA–EPs and MA-affiliated 

eligible hospitals that the qualifying MA 

organization believes would be 

meaningful users of CEHRT during the 

reporting period, when a qualifying MA 

organization intends to claim an 

incentive payment for a given qualifying 

MA–EP or MA-affiliated eligible 

hospital. 

We also proposed an amendment to 

§ 495.202(b)(2) to reflect current policy 

that qualifying MA organizations must 

report the CMS Certification Number 

(CCN) for qualifying MA-affiliated 

eligible hospitals. We explained that as 

the program matures, it is necessary to 

report this detail to effectively 

administer the program. We are 

adopting this change in this final rule 

(§ 495.202(b)(2)). 

We proposed a new § 495.202(b)(3) to 

establish a reporting requirement to 

identify qualifying MA–EPs who have 

furnished more than 50 percent of their 

covered Medicare professional services 

to MA enrollees of the qualifying MA 

organization in a designated geographic 

Health Professional Shortage Area 

(HPSA) during the reporting period. We 

also proposed to redesignate the current 

§ 495.202(b)(3) as (b)(4), and revised the 

introductory language in (b)(2) to reflect 

this redesignation. 

We also proposed to require MA 

organizations to identify qualifying 

MA–EPs or MA-affiliated eligible 

hospitals within 2 months of the close 

of the payment year (rather than within 

60 days) (previously § 495.202(b)(3), 

now newly redesignated 

§ 495.202(b)(4)). We explained that this 

change would be consistent with the 

Medicare FFS EHR Incentive Program, 

but in nonleap years this would reduce 

the time for reporting revenue amounts 

to CMS for qualifying MA–EPs from 60 

days to 59 days. We proposed 

conforming amendments to 

§ 495.204(b)(2) and § 495.210(b) and (c). 

We also explained that because the 

redesignated § 495.202(b)(4) relates to 

both the payment phase and the 

payment adjustment phase of the 

program, we are adding the word 

‘‘qualifying’’ to the text of the 

regulation. Therefore, we explained, this 

regulation applies to both qualifying 

MA–EPs and MA-affiliated eligible 

hospitals (both payment and payment 

adjustment phases of the program) and 

mstockstill on DSK4VPTVN1PROD with RULES2

54114 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

potentially qualifying MA–EPs and MAaffiliated eligible hospitals (only the 

payment adjustment phase of the 

program). 

We proposed to redesignate the 

current § 495.202(b)(4) as 

§ 495.202(b)(5), and to require a 

qualifying MA organization to identify 

the MA–EPs and MA-affiliated eligible 

hospitals that it believes would be both 

‘‘qualifying’’ and ‘‘potentially 

qualifying.’’ To calculate the payment 

adjustment, we explained that we will 

need to know how many qualifying 

MA–EPs and MA-affiliated eligible 

hospitals are, and are not, meaningful 

users. We also proposed to correct a 

cross-reference. 

We did not receive any comments on 

these provisions and we are finalizing 

them as proposed. 

3. Incentive Payments to Qualifying MA 

Organizations for Qualifying MA–EPs 

and Qualifying MA-Affiliated Eligible 

Hospitals (§ 495.204) 

a. Amount Payable to a Qualifying MA 

Organization for Its Qualifying MA–EPs 

In § 495.204(b), we proposed to clarify 

that methods relating to overhead costs 

may be submitted for MA–EPs 

regardless of whether the MA–EPs are 

salaried or paid in another fashion, such 

as on a capitated basis. 

As stated previously, we also 

proposed to require MA organizations, 

to submit revenue amounts relating to 

their qualifying MA–EPs within 2 

months of the close of the payment year, 

(rather than within 60 days). 

b. Increase in Incentive Payment for 

MA–EPs Who Predominantly Furnish 

Services in a Geographic Health 

Professional Shortage Area (HPSA) 

In a new § 495.204(e) (we proposed to 

redesignate the current paragraph (e) as 

paragraph (f)), we proposed to add a 

provision clarifying the currently 

existing policy governing whether a 

qualifying MA organization is entitled 

to a HPSA increase for a given 

qualifying MA–EP. We explained that 

section 1848(o)(1)(B)(iv) of the Act, 

which is currently in effect, and as 

applied to the MA program, provides a 

10-percent increase in the maximum 

incentive payment available for MA– 

EPs that predominantly furnish covered 

professional services during the MA 

EHR payment year in a geographic 

HPSA. We explained that consistent 

with the Medicare FFS EHR Incentive 

Program, we interpreted the term 

‘‘predominantly’’ to mean more than 50 

percent. For the MA EHR Incentive 

Program, we proposed to determine 

eligibility for the geographic HPSA 

increase on whether the qualifying MA– 

EP predominantly provided services to 

MA plan enrollees of the qualifying MA 

organization in a HPSA during the 

applicable MA EHR payment year. 

Further, we explained that it is worth 

noting that an MA organization does not 

automatically receive a HPSA bonus 

merely because its qualifying MA–EPs 

predominantly served a geographic 

HPSA. We stated that in order for the 

MA organization to receive the 10 

percent increase, the MA–EP needs to 

provide at least 10 percent or more of 

Medicare Part B covered professional 

services to MA plan enrollees of the 

qualifying MA organization. In other 

words, to qualify for the HPSA bonus an 

MA–EP needs to provide more than 

$24,000 of Medicare Part B covered 

professional services to MA plan 

enrollees of the qualifying MA 

organization. The MA–EP needs to 

provide up to $26,400 in covered 

services to earn the maximum HPSAenhanced bonus of $19,800 if the first 

payment year is 2011 or 2012. Thus, for 

MA–EPs who predominantly furnish 

services in a geographic HPSA, the 

‘‘incentive payment limit’’ in 

§ 495.102(b) would be $19,800, instead 

of $18,000, if the first MA EHR payment 

year for the MA organization with 

respect to the MA–EP is 2011 or 2012. 

If an MA organization could show that 

an MA–EP predominantly served 

beneficiaries in a HPSA during the 

payment year and that that MA–EP 

provided, for example, for the 2011 

payment year, at least $26,400 in Part B 

professional services to MA plan 

enrollees of the MA organization during 

the payment year, we stated that the MA 

organization could receive the entire 

$19,800 incentive payment for that MA– 

EP. If the MA–EP provided less than 

$26,400 in Part B professional services, 

the potential incentive payment for that 

MA–EP for that MA organization would 

be less than $19,800 for the payment 

year. We proposed a conforming 

amendment in § 495.202(b)(2)(ii) to 

require MA organizations to notify CMS 

whether the qualifying MA–EP 

predominantly provided covered 

services to MA plan enrollees in a 

HPSA. 

We added a new paragraph (5) to 

redesignated paragraph (f). This new 

paragraph (5) clarifies that we would 

recoup the EHR incentive payment if 

one of the following entities fails to 

comply with an audit request to 

produce documents or data needed to 

audit the validity of an EHR incentive 

payment:—(1) A qualifying MA–EP, (2) 

an entity that employs a qualifying MA– 

EP (or in which a qualifying MA–EP had 

a partnership interest), (3) an MAaffiliated eligible hospital, or (4) any 

other party contracting with the 

qualifying MA organization. We 

explained that we already have the 

authority to do this under the current 

§ 495.204(e)(4), (to be redesignated as 

(f)(4)); however, we proposed to amend 

the regulations to specifically address 

what would happen in the case of a 

failure to produce documents or data 

related to an audit request. 

We added a new paragraph (g) to 

§ 495.204 to clarify the current policy 

that in the unlikely event we paid a 

qualifying MA organization for a 

qualifying MA–EP, and it was later 

determined that the MA–EP—(1) was 

entitled to a full incentive payment 

under the Medicare FFS EHR Incentive 

Program; or (2) had received payment 

under the Medicaid EHR Incentive 

Program, we would recover the funds 

paid to the qualifying MA organization 

for such an MA–EP from the MA 

organization. (We stated that the former 

case would be in the unlikely event an 

MA–EP appeared to have earned an 

EHR incentive of less than the full 

amount under FFS, and then later was 

determined to have earned the full 

amount under FFS. In accordance with 

duplicate payment avoidance provisions 

in section 1853(l)(3)(B) of the Act and 

implementing regulations at § 495.208, 

we would recover the MA EHR 

incentive payment since a full FFS EHR 

payment was due.) If the organization 

still had an MA contract, we would 

recoup the amount from the MA 

organization’s monthly payment under 

section 1853(a)(1)(A) of the Act. If the 

organization no longer had an MA 

contract, we would recoup any amounts 

through other means, such as formal 

collection. We stated that since 

duplicate and overpayments are 

prohibited by statute (sections 

1853(l)(3)(B), 1853(m)(3)(B), and 

1903(t)(2) of the Act), we believe that 

this policy must apply to all years of the 

program, beginning with payment year 

2011. Thus, we would recover overpaid 

MA EHR incentive payments for all MA 

EHR payment years, including payment 

year 2011. 

We also clarified that, in accordance 

with statutory requirements, if it is 

determined that an MA organization 

received an incentive payment for an 

MA-affiliated eligible hospital that also 

received a payment under the Medicare 

FFS EHR Incentive program or that 

otherwise should not have received 

such payment, we would similarly 

recover the funds paid to the qualifying 

MA organization for such MA-affiliated 

eligible hospital from either the MA 

organization’s monthly payment under 

section 1853(a)(1)(A) of the Act, from 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54115 

the MA-affiliated eligible hospital’s 

CMS payment through the typical 

process for recouping Medicare funds 

from a ‘‘subsection (d)’’ hospital, or 

through other means such as a 

collection process, as necessary. As with 

EPs, as the statute prohibits us from 

making duplicate and overpayments, we 

explained that this policy does not 

constitute a new rule and must apply to 

all years of the program, beginning with 

payment year 2011. 

We did not receive any comments on 

these provisions and are finalizing them 

as proposed. 

4. Avoiding Duplicate Payments 

We stated that qualifying MA–EPs are 

eligible for the Medicare FFS EHR 

incentive payment if they meet certain 

requirements under that program. 

However, we also stated that an EHR 

incentive payment is only allowed from 

one program. We believe that the 

requirement that MA organizations 

notify MA–EPs that the MA 

organization intended to claim them for 

the MA EHR Incentive Program would 

minimize misunderstandings among 

MA–EPs (particularly if they expected 

to receive an incentive payment under 

the Medicare FFS Incentive Program). 

We stated that it was important for MA– 

EPs to understand certain aspects of the 

program such as when a qualifying MA 

organization claimed an MA–EP under 

the MA EHR Incentive Program and the 

MA–EP was not entitled to a full FFS 

EHR Incentive payment, the MA 

organization claim would prevent a 

partial payment under the Medicare FFS 

EHR Incentive Program from being paid 

directly to the MA–EP. 

We proposed to require each 

qualifying MA organization to attest that 

it notified the MA–EPs it intends to 

claim. We proposed to require that this 

attestation be submitted along with the 

MA organization’s meaningful use 

attestation for the MA EHR payment 

year for which the MA organization is 

seeking payment. 

Therefore, we proposed to revise 

§ 495.208 by adding—(1) a new 

paragraph (a) that requires a qualifying 

MA organization to notify MA–EPs 

when the MA organization intends to 

claim them for the MA EHR Incentive 

Program prior to making its attestation 

of meaningful use to CMS; (2) a new 

paragraph (b) that requires a qualifying 

MA organization to notify MA–EPs 

when it is claiming them, that the MA– 

EPs may still receive an incentive 

payment under the Medicare FFS or 

Medicaid EHR Incentive Program, if 

certain requirements are met; and (3) a 

new paragraph (c) that requires a 

qualifying MA organization to attest to 

CMS that these notification 

requirements have been satisfied by the 

MA organization. We also proposed to 

redesignate the current paragraphs (a) 

through (c) of § 495.208 as (d) through 

(f), respectively. 

As discussed previously, in § 495.210, 

we proposed to change the requirement 

that MA organizations attest to 

meaningful use within 60 days after the 

close of the MA EHR payment year for 

both MA–EPs and MA-affiliated eligible 

hospitals, to a requirement to do so 

within 2 months in order to provide 

consistency between the Medicare FFS 

and MA EHR Incentive Programs. 

Comment: A commenter requested 

that CMS confirm that MA organization 

reporting to CMS under HEDIS, HOS, 

and CAHPS will continue to apply for 

purposes of the MA EHR Incentive 

Payment Program during Stage 2. The 

commenter questioned if MA 

organizations, for both qualifying MA– 

EPs and MA-affiliated eligible hospitals, 

will be permitted to continue to submit 

HEDIS, HOS, and CAHPS data in lieu of 

CQMs during Stage 2. 

Response: We are confirming that 

during Stage 2 and subsequent stages of 

MA EHR Program implementation, we 

will continue to require qualifying MA 

organizations to successfully report 

HEDIS, HOS, and CAHPS measures in 

lieu of CQMs for purposes of 

meaningful use reporting for qualifying 

MA–EPs and MA-affiliated eligible 

hospitals. 

After review of the public comments 

received, we are finalizing these 

provisions as proposed. 

5. Payment Adjustments Effective for 

2015 and Subsequent MA Payment 

Adjustment Years (§ 495.211) 

In the proposed rule we explained 

that beginning in 2015, the law provides 

for adjustments to monthly MA 

payments under sections 1853(l)(4) and 

1853(m)(4) of the Act if a qualifying MA 

organization’s potentially qualifying 

MA–EPs or MA-affiliated eligible 

hospitals (or both) are not meaningful 

users of certified EHR technology. We 

proposed to add a definition of ‘‘MA 

Payment Adjustment Year’’ to the 

definitions in § 495.200. The definition 

was needed in part because the payment 

adjustment phase of the MA EHR 

program continued indefinitely— 

beyond the last year for which MA EHR 

incentive payments could be made to 

qualifying MA organizations. 

Additionally, since we proposed to 

operationalize MA EHR payment 

adjustments in a different manner than 

under the FFS Medicare program, we 

believed a definition was warranted. 

We proposed that an MA organization 

would have to had at least initiated 

participation in the incentive payment 

phase of the program from 2011 through 

2014 for MA–EPs or through 2015 for 

MA-affiliated eligible hospitals, to have 

its Part C payment under section 

1853(a)(1)(A) of the Act adjusted during 

the payment adjustment phase of the 

program, and would have to continue to 

qualify for participation in the program 

as a ‘‘qualifying MA organization’’ as 

defined for purposes of this program. 

The imposition of a payment adjustment 

is also conditioned on the qualifying 

MA organization having potentially 

qualifying MA–EPs and MA-affiliated 

eligible hospitals for the respective 

payment adjustment years. We took this 

approach because we believed that it 

would be impossible to verify that a 

given MA organization is, in fact, a 

qualifying MA organization with 

potentially qualifying MA–EPs and MAaffiliated eligible hospitals, unless the 

MA organization had first demonstrated 

that it met these requirements through 

receipt of MA EHR incentive payments 

for at least one of the MA EHR payment 

years as defined for purposes of this 

program. We noted that although MA 

EHR payment years for both MA–EPs 

and MA-affiliated eligible hospitals 

could theoretically continue through 

2016, the last first MA EHR payment 

year for which an MA organization 

could receive an EHR incentive 

payment is 2014 for MA–EPs, and 2015 

for MA-affiliated hospitals. 

Furthermore, we believe that payment 

adjustments under section 1853 of the 

Act would have limited applicability in 

the MA EHR Incentive Program because 

the HITECH Act limited the type of 

organization that would qualify as a 

‘‘qualifying MA organization’’ for 

purposes of the MA EHR Incentive 

Program in both phases of the program 

(the phase of the program during which 

we make incentive payments, and the 

phase of the program when we adjust 

payments under sections 1853(l)(4) and 

1853(m)(4) of the Act). We stated that 

section 1853(l)(5) of the Act limits 

which MA organizations may 

participate by defining the term 

‘‘qualifying MA organization.’’ We 

explained that a ‘‘qualifying MA 

organization’’ must be organized as a 

health maintenance organization 

(HMO), as defined in section 2791(b)(3) 

of the Public Health Service (PHS) Act 

(42 U.S.C. 1395w–23(l)(5)). The PHS Act 

further defines an HMO as a ‘‘federally 

qualified HMO, an organization 

recognized under state law as an HMO, 

or a similar organization regulated 

under state law for solvency in the same 

mstockstill on DSK4VPTVN1PROD with RULES2

54116 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

manner and to the same extent as such 

an HMO.’’ (See 42 U.S.C. 300gg–91). We 

explained that an MA organization 

participating in Medicare Part C might 

not be a federally qualified HMO, nor an 

organization recognized under state law 

as an HMO, nor a similar organization 

regulated under state law for solvency 

in the same manner and to the same 

extent as such an HMO. We noted that 

organizations that do not meet the PHS 

definition of ‘‘HMO’’ may not receive an 

incentive payment, nor would they be 

eligible to have their Part C payment 

adjusted for having potentially 

qualifying MA–EPs or MA-affiliated 

eligible hospitals that do not 

successfully demonstrate meaningful 

use of certified EHR technology. 

Secondly, section 1853(l)(2) of the Act 

requires that MA–EPs be as described in 

that paragraph. We stated that the vast 

majority of MA organizations do not 

employ their physicians; nor do they 

use physicians who work for, or who are 

partners of, an entity that contracts 

nearly exclusively with the MA 

organization (as set out in the definition 

of a ‘‘Qualifying MA–EP’’ in § 495.200). 

Thirdly, section 1853(m)(2) of the Act 

requires that a qualifying MA 

organization have common corporate 

governance with a hospital in order for 

it to be considered an MA-affiliated 

eligible hospital, and we did not expect 

many qualifying MA organizations to 

meet this test. 

We explained that the current 

§ 495.202(b)(4) (which we proposed to 

redesignate as § 495.202(b)(5)) requires 

all qualifying MA organizations that 

have potentially qualifying MA–EPs or 

MA-affiliated eligible hospitals that are 

not meaningful users to initially report 

that fact to us beginning in June of MA 

plan year 2015. We proposed that this 

reporting requirement would include 

only qualifying MA organizations that 

participated in and received MA EHR 

incentive payments. 

Further, we discussed that there may 

be MA organizations that participated in 

the incentive payment phase of the 

program, but then ceased being 

qualifying MA organizations, or that no 

longer have any qualifying MA–EPs or 

MA-affiliated eligible hospitals. We 

provided an example of a qualifying MA 

organization that contracts with a 

specific entity to deliver physicians’ 

services during the payment phase of 

the EHR Incentive Program, but then the 

entity changes, or the MA organization 

loses its contract with the entity. We 

explained that such changes could 

cause the MA organization’s MA EPs to 

no longer meet the 80/80/20 rule due to 

loss of the contract, or the entity might 

begin contracting with additional MA 

organizations. (See § 495.200, for the 

definition of ‘‘Qualifying MA–EP.’’) 

Therefore, we explained, the MA 

organization would not necessarily have 

its monthly payment adjusted because it 

might no longer meet the basic 

requirements under which MA EHR 

incentive payments were made to it. 

Therefore, we proposed to adjust 

payments, beginning for payment 

adjustment year 2015, only for 

qualifying MA organizations that 

received MA EHR payments and that 

had potentially qualifying MA–EPs or 

MA-affiliated eligible hospitals that 

were not meaningful EHR users. We 

proposed to rely on the existing selfreporting requirement in redesignated 

§ 495.202(b)(5) and subsequent audits to 

ensure compliance. 

Comment: A commenter 

recommended that CMS apply MA 

payment adjustments to qualifying MA 

organizations only for the category of 

MA provider (that is, MA–EP versus 

MA-affiliated hospital) for which it 

claimed and received MA EHR 

incentive payments. For example, if a 

qualifying MA organization claimed 

incentive payments during the payment 

phase of the program only for MA–EPs 

and not for any MA-affiliated eligible 

hospitals, then the MA organization 

should only be required to report on 

qualifying and potentially qualifying 

MA–EPs during the adjustment phase of 

the program, and should not be subject 

to payment adjustments for MAaffiliated hospitals. 

Response: We agree with the 

commenter that we will apply payment 

adjustments only to qualifying MA 

organizations for the category (or 

categories) of MA provider (either MA– 

EP, MA-affiliated eligible hospital, or 

both) for which it claimed and received 

MA EHR incentive payments. To the 

same extent that qualifying MA 

organizations have identified 

themselves and their qualifying MA– 

EPs and/or MA-affiliated eligible 

hospitals during the payment phase of 

the MA EHR Incentive Program, we 

expect them to continue to identify 

themselves and their MA–EPs and MAaffiliated hospitals during the 

adjustment phase of the program. We 

are taking this approach because we 

believe it would be impossible to verify 

that a given qualifying MA organization 

has potentially qualifying MA–EPs or 

MA-affiliated eligible hospitals, unless 

it had first identified those providers to 

us. We have modified § 495.211(c) to 

clarify that MA EHR payment 

adjustments with respect to MAaffiliated hospitals will only apply to 

qualifying MA organizations that 

previously received incentive payments 

under the MA EHR Incentive Program 

for MA-affiliated hospitals, and 

similarly, that MA EHR payment 

adjustments with respect to MA–EPs 

will only apply to qualifying MA 

organizations that previously received 

incentive payments under the MA EHR 

Incentive Program for MA–EPs. 

We proposed to collect payment 

adjustments made under sections 

1853(l)(4) and 1853(m)(4) of the Act 

after meaningful use attestations have 

been made. Final attestations of 

meaningful use occur after the end of an 

EHR reporting period, which for MA– 

EPs would run concurrent with the 

payment adjustment year. In the case of 

potentially qualifying MA-affiliated 

eligible hospitals, attestations of 

meaningful use would occur by the end 

of November after the EHR reporting 

period. As noted previously, we 

proposed to amend § 495.202(b) to 

indicate that in addition to initial 

identification of potentially qualifying 

MA–EPs and MA-affiliated eligible 

hospitals that are not meaningful users 

(as required by redesignated 

§ 495.202(b)(5)), qualifying MA 

organizations would also need to finally 

identify such MA–EPs and MAaffiliated eligible hospitals within 2 

months of the close of the applicable 

EHR reporting period. Final 

identification by qualifying MA 

organizations of potentially qualifying 

MA–EPs and/or MA-affiliated eligible 

hospitals that are not meaningful users 

would then result in application of a 

payment adjustment by CMS. On the 

other hand, final identification of all 

qualifying MA–EPs and/or MA-affiliated 

eligible hospitals as meaningful users 

would obviate an adjustment. We stated 

that, through audit, we would verify the 

accuracy of an applicable MA 

organization’s assertions or 

nonreporting. 

We proposed to adjust one or more of 

the qualifying MA organization’s 

monthly MA payments made under 

section 1853(a)(1)(A) of the Act after the 

qualifying MA organization attested to 

the percent of hospitals and 

professionals that either were, or were 

not, meaningful users of certified EHR 

technology. We stated that, to the extent 

a formerly qualifying MA organization 

did not report under § 495.202(b)(4) or 

(5), we would verify, upon audit, the 

accuracy of the applicable MA 

organization’s nondisclosure of such 

qualifying and potentially qualifying 

users. 

Under our proposed approach, the 

adjustment would be calculated based 

on Part C payment data made under 

section 1853(a)(1)(A) of the Act for the 

payment adjustment year. We stated 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54117 

that since an MA-affiliated eligible 

hospital must attest to meaningful use 

by November 30th, we could use the 

Part C payment information in effect at 

the time of the attestation to calculate 

the payment adjustment for a specific 

potentially qualifying MA-affiliated 

eligible hospital with respect to a 

specific MA organization. Although we 

expected (and preferred) to make an 

adjustment to a single MA monthly 

payment totaling the adjustment for the 

year, we requested comment on whether 

more than one monthly payment should 

be adjusted. We stated that one possible 

approach would be to make this 

decision on a case-by-case basis 

depending upon a given qualifying MA 

organization’s situation (for example, 

payment adjustment amount versus MA 

organization monthly payment). 

For payment adjustments based on 

potentially qualifying MA–EPs that are 

not meaningful users of certified EHR 

technology, we also proposed to 

calculate the adjustment based on the 

Part C payment made under section 

1853(a)(1)(A) of the Act for the payment 

adjustment year. Because attestations of 

meaningful use for qualifying MA–EPs 

occur in February of the calendar year 

following the EHR reporting year, we 

noted that we could calculate the 

payment adjustment based on the prior 

MA payment year’s payment, and that 

we could apply that adjustment to one 

or more of the prospective Part C 

payments. While we preferred to make 

an adjustment to one MA prospective 

payment for the full amount of the 

payment adjustment when possible, we 

solicited comment on whether we 

should make adjustments over several 

months or in a single month (for the 

entire adjustment amount), when 

possible. We received no comments on 

this proposal and therefore we are 

adopting the policy of collecting 

payment adjustments as quickly as 

possible in a single month, when 

possible. 

Thus, adjustments for MA payment 

adjustment year 2015 would be based 

on MA payment data under section 

1853(a)(1)(A) of the Act. However, while 

the payment adjustment for the 2015 

payment adjustment year would be 

collected as soon as possible, we stated 

that this might not be until CY 2016 

through an adjustment to the MA 

organization’s MA capitation payment 

or payments under section 1853(a)(1)(A) 

of the Act. 

We stated that proposed § 495.211(c) 

made clear that the potentially 

qualifying MA–EP and MA-affiliated 

eligible hospital payment adjustments 

would be calculated separately, and that 

each adjustment was applied to the 

qualifying MA organization’s monthly 

payment under section 1853(a)(1)(A) of 

the Act. As discussed previously, we are 

modifying § 495.211(c) to clarify that 

MA EHR payment adjustments for MAaffiliated hospitals only apply to 

qualifying MA organizations that 

previously received incentive payments 

under the MA EHR Incentive Program 

for MA-affiliated hospitals, and that 

payment adjustments for MA–EPs only 

apply to qualifying MA organizations 

that previously received incentive 

payments under the MA EHR Incentive 

Program for MA–EPs. 

Proposed paragraphs (a) through (c) 

would apply to adjustments based on 

both potentially qualifying and 

qualifying MA–EPs and MA-affiliated 

eligible hospitals that were not 

meaningful EHR users. Proposed 

paragraph (d) would apply only to 

adjustments based on potentially 

qualifying and qualifying MA–EPs that 

were not meaningful users of certified 

EHR technology. We also stated that 

paragraph (d) makes it clear that if a 

potentially qualifying MA–EP was not a 

meaningful user of CEHRT in payment 

adjustment year 2015 (and subsequent 

payment adjustment years), the 

qualifying MA organization’s monthly 

Part C payment would be adjusted 

accordingly. 

During the payment phase of the MA 

EHR Incentive Program qualifying MA 

organizations attest to meaningful use 

for each qualifying MA–EP and MAaffiliated eligible hospital they claimed. 

We also stated that during the payment 

adjustment phase of the program, we 

would need to know the percentage of 

both qualifying and potentially 

qualifying MA–EPs and MA-affiliated 

eligible hospitals that were not 

meaningful users of certified EHR 

technology. This percentage could be 

derived by taking the total number of 

the qualifying MA organization’s 

qualifying and potentially qualifying 

MA–EPs, or MA-affiliated eligible 

hospitals, and identifying the portion of 

those MA–EPs or MA-affiliated 

hospitals that were not meaningful EHR 

users. We would use this percentage to 

make the adjustment proportional to the 

percent that were not meaningful users 

for a given adjustment year and 

qualifying MA organization. 

Moreover, in determining the 

proportion of potentially qualifying 

MA–EPs and potentially qualifying MAaffiliated eligible hospitals (those that 

were not meaningful users), we would 

exclude EPs and hospitals that were 

neither qualifying nor potentially 

qualifying in accordance with the 

definition of ‘‘qualifying’’ and 

‘‘potentially qualifying MA–EPs’’ and 

‘‘MA-affiliated eligible hospitals’’ in 

§ 495.200. Thus, an MA–EP that was a 

hospital-based EP would not be a 

qualifying or potentially qualifying MA– 

EP since such an EP did not meet item 

(5) of the definition of qualifying MA– 

EP in § 495.200 and thus would not be 

used in our computation of the 

proportion of MA–EPs for purposes of 

applying the payment adjustment. We 

proposed the following formula to apply 

the payment adjustments proposed in 

§ 495.211(d)(2) to MA–EPs: 

[the total number of potentially 

qualifying MA–EPs]/[(the total 

number of potentially qualifying 

MA–EPs) + (the total number of 

qualifying MA–EPs)]. 

Similarly, the formula we proposed 

for purposes of applying payment 

adjustments in § 495.211(e)(2)(iii) with 

respect to MA-affiliated hospitals was: 

[the total number of potentially 

qualifying MA-affiliated eligible 

hospitals]/[(the total number of 

potentially qualifying MA-affiliated 

eligible hospitals) + (the total 

number of qualifying MA-affiliated 

eligible hospitals)]. 

Keeping in mind that redesignated 

§ 495.202(b)(4) and (5) required 

qualifying MA organizations to identify 

potentially qualifying MA–EPs and 

potentially qualifying MA-affiliated 

eligible hospitals and to provide other 

information beginning for plan year 

2015, we solicited comment on the 

question of whether, in the payment 

adjustment phase of this program, 

qualifying MA organizations with 

potentially qualifying MA–EPs and MAaffiliated eligible hospitals should—(1) 

still be required to attest to the 

meaningful use objectives and 

measures; or (2) instead be required 

only to report the percent of MA–EPs 

and MA-affiliated eligible hospitals that 

are not meaningful users of certified 

EHR technology. We suggested that 

commenters take into account that MAaffiliated eligible hospitals would still 

be required to perform a reporting 

function on behalf of their MA-affiliated 

organization in the National Level 

Repository (NLR), and that they were 

generally bound to ‘‘subsection (d)’’ 

hospital reporting requirements of the 

NLR. Thus, we were primarily 

interested in comments related to MA– 

EPs. 

We explained that while we wished to 

minimize burden, we were also 

concerned with our ability to audit the 

information reported to ensure 

compliance with MA program 

requirements. Having received no 

comments on this provision, we 

therefore adopt a final requirement to 

mstockstill on DSK4VPTVN1PROD with RULES2

54118 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

use only percentage-based reporting 

and, require MA organizations to retain 

and produce data and records necessary 

to substantiate their submissions, 

including evidence of meaningful use 

by those MA–EPs and MA-affiliated 

eligible hospitals so reported. 

We proposed that payment 

adjustments for MA–EPs would be 

calculated by multiplying: (1) The 

percent established under 

§ 495.211(d)(4) (which, in accordance 

with the statute, increases the 

adjustment amount up until 2017 and 

potentially beyond); with (2) the 

Medicare Physician Expenditure 

Proportion; and (3) by the percent of the 

qualifying MA organization’s qualifying 

and potentially qualifying MA–EPs that 

were not meaningful users. We 

explained that section 1853(l)(4)(B)(i) of 

the Act requires MA payments to be 

reduced using the ‘‘percentage points’’ 

reduction of section 1848(a)(7)(A)(ii) of 

the Act. As section 1848(a)(7)(A)(ii) of 

the Act is ‘‘subject to clause (iii),’’ and 

as clause (iii) of that same provision 

requires payment adjustments to 

increase when the proportion of EPs 

who are meaningful EHR users is less 

than 75 percent, we proposed to apply 

a similar policy for the MA program. 

Specifically, we proposed that if the 

proportion of MA–EPs of a qualifying 

MA organization did not meet the 75 

percent threshold (as determined in 

proposed § 495.211(d)(2)) in 2018 and 

subsequent years, the percentage 

reduction could increase to 4 percent in 

2018, and 5 percent in 2019 and 

subsequent years. We did not propose a 

possible 2 percent reduction for 2015 

(consistent with the Medicare FFS EHR 

Incentive Program when an EP is subject 

to an adjustment in 2014 under the eprescribing program), because MA 

organizations are not independently 

subject to e-prescribing payment 

adjustments. 

We proposed that the Medicare 

Physician Expenditure Proportion for a 

year would be the Secretary’s estimate 

of expenditures under Parts A and B not 

attributable to Part C that are 

attributable to expenditures for 

physician services. While we proposed 

a uniform portion for all MA 

organizations, we also proposed to 

adjust the proportion on a more 

individual basis to account for the fact 

that qualifying MA organizations may 

contract with a large number of EPs that 

are neither qualifying nor potentially 

qualifying. We explained that this 

individualized policy was based on the 

statutory language in section 1853(l)(1) 

of the Act, which states that the 

provisions of section 1848(a)(7) of the 

Act (that is, the payment adjustments) 

apply ‘‘with respect to’’ the EPs 

‘‘described in paragraph (2)’’ of section 

1853(l) of the Act. As section 1853(l)(2) 

of the Act creates several additional 

requirements for MA–EPs (that is, that 

they be employed by the qualifying MA 

organization, that they meet the 80/80/ 

20 requirements, and so on), we 

proposed adjusting the Physician 

Expenditure Proportion to recognize 

that many EPs may not qualify as MA– 

EPs, regardless of meaningful use. Thus, 

we proposed to adjust each MA 

organization’s Physician Expenditure 

Proportion to recognize that not all of 

the EPs would meet the technical 

(nonmeaningful use) requirements to be 

potentially qualifying or qualifying MA– 

EPs. Without our proposed adjustment, 

a small sample size of MA–EPs could 

magnify the reduction amount during 

the payment adjustment phase of the 

program, because the actions of a 

limited set of qualifying and potentially 

qualifying MA–EPs (and whether they 

meaningfully used certified EHR 

technology) would determine whether 

all of an MA organization’s physician 

expenditure proportion was reduced. 

We provided an example of our 

proposed MA payment adjustment for 

adjustment year 2015 as follows: 

Assume the hypothetical Medicare 

Physician Expenditure Proportion, 

adjusted as described previously, is 10 

percent for 2015; 

The qualifying MA organization’s 

percent of qualifying and potentially 

qualifying MA–EPs that are not 

meaningful users is 15 percent for 2015; 

and 

The monthly payment in 2015 for the 

given qualifying MA organization is 

$10,000,000. 

The proposed formula would read as 

follows: 

0.01 (the payment adjustment for 2015) 

× 0.1 (the hypothetical Medicare 

Physician Expenditure Proportion) 

× 0.15 (the percentage of qualifying 

and potentially qualifying MA–EPs 

that are not meaningful EHR users) 

× $10,000,000 (monthly Part C 

payment) × 12 (number of months 

in the MA payment year) = $18,000 

for the entire year, or $1,500 a 

month. We proposed that this 

adjustment would then be collected 

against one or more of the 

qualifying MA organization’s 

payments under section 

1853(a)(1)(A) of the Act. 

In proposed § 495.211(e), we set out a 

formula for payment adjustments based 

on potentially qualifying MA-affiliated 

eligible hospitals that are not 

meaningful users of certified EHR 

technology. 

We proposed an adjustment equal to 

the product of the following: 

• Monthly Part C payment for the 

payment adjustment year; 

• The percentage point reduction that 

applies to FFS hospitals as a result of 

section 1886(b)(3)(B)(ix)(I) of the Act; 

• The Medicare hospital expenditure 

proportion, adjusted in the same 

manner as the Physician Expenditure 

Proportion to recognize that not all 

hospitals are necessarily qualifying or 

potentially qualifying MA-affiliated 

eligible hospitals; and 

• The percentage of qualifying and 

potentially qualifying MA-affiliated 

eligible hospitals of a given qualifying 

MA organization that are not 

meaningful users of certified EHR 

technology. 

We proposed that the percentage 

point reduction of the first bullet (that 

is, the reduction that applies as a result 

of section 1886(b)(3)(B)(ix)(I) of the Act) 

would be based on the point reduction 

that results when three-fourths of the 

otherwise applicable percentage 

increase for the fiscal year was reduced 

by 331⁄3 percent for FY 2015, 662⁄3

percent for FY 2016, and 100 percent for 

FY 2017 and subsequent fiscal years. 

We stated this had the result of 

decreasing the otherwise applicable 

market basket update by one-fourth (for 

2015), one-half (for 2016), and threefourths (for 2017 and subsequent 

payment adjustment years). 

We stated that the Medicare Hospital 

Expenditure Proportion for a year was 

the Secretary’s estimate of expenditures 

under Medicare Parts A and B that were 

not attributable to Part C, that were 

attributable to expenditures for 

inpatient hospital services. As 

mentioned previously, we proposed that 

this proportion reflects only the MAaffiliated eligible hospitals that were 

either qualifying or potentially 

qualifying MA-affiliated eligible 

hospitals. 

We also proposed to use the market 

basket percentage increase that would 

otherwise apply to ‘‘subsection (d)’’ 

hospitals for an MA payment 

adjustment year. We provided the 

following hypothetical example. The 

market basket percentage increase for 

FY 2015 was hypothetically 4 percent. 

Three-quarters of one-third of 4 percent 

would be 1 percent. The hypothetical 

Medicare Hospital Expenditure 

proportion for the year was 15 percent, 

and one of two of the relevant MAaffiliated eligible hospitals was not a 

meaningful EHR user for the applicable 

period (FY 2015). The monthly payment 

to the MA organization in 2015 was 

$10,000,000 a month. 

The calculation would be as follows: 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54119 

0.01 (the market basket percentage point 

reduction) × 0.15 (the Medicare 

Hospital Expenditure Proportion) × 

0.5 (percent of the qualifying MA 

organization’s qualifying and 

potentially qualifying MA-affiliated 

eligible hospitals that are not 

meaningful users) × $10,000,000 

(monthly Part C payment) × 12 

(number of months in the MA 

payment year) = $90,000 for the 

year, or $7,500 a month. The 

payment adjustment would be 

applied on either a monthly basis, 

or in one adjustment. As stated 

previously, we requested comment 

on this aspect of the final rule. 

Comment: A commenter stated that 

the formula for computing the Medicare 

Physician Expenditure Proportion 

percent in § 495.211(d)(3)(ii) was not 

clear on whether physicians who saw 

no Medicare patient at all would be 

excluded from the expenditure 

proportion calculation (for example, 

most pediatricians), and whether a 

distinction would be made between 

services provided by MA–EPs and 

potential MA–EPs of the organization, 

and other physicians and the services 

they provide. The commenter explained 

that under the model of reimbursement 

for physician services it uses, the ability 

to track Part A and Part B costs to 

individual physicians was limited. The 

commenter proposed an alternate 

method for computing the Medicare 

Physician Expenditure Proportion based 

on what it called a ‘‘uniform 

distribution model as a proxy for the 

adjustment to the MPEP percent.’’ 

Response: We believe it is 

unnecessary to specifically exclude 

physicians, such as pediatricians, who 

see no Medicare patients from the 

Medicare Physician Expenditure 

Proportion calculation. Expenditures 

that are provided by EPs that are neither 

qualifying nor potentially qualifying 

MA–EPs are already adjusted out. This 

would be true in two ways for 

physicians, such as pediatricians, who 

see no Medicare patients. First, these 

physicians would not meet item (2) of 

the definition of a ‘‘qualifying MA–EP’’ 

in § 495.200, since these physicians do 

not provide ‘‘at least 80 percent’’ of their 

Medicare-covered professional services 

to enrollees of the qualifying MA 

organization. Since they provide no 

Medicare-covered professional services 

to enrollees of the qualifying MA 

organization, they do not meet the ‘‘80 

percent’’ requirement. Second, the 

Physician Expenditure Proportion is 

based only on Medicare expenditures 

for physician services (that is, the 

proportion of expenditures under Parts 

A and B not attributable to Part C that 

are attributable to expenditures for 

physician’s services). Physician 

expenditures for non-Medicare services 

(like most services of a pediatrician) do 

not count in the calculation. Finally, we 

do not believe an alternative method of 

computing the Medicare Physician 

Expenditure Proportion is necessary and 

therefore are not considering the 

alternate approach proposed by this 

commenter in this final rule. It should 

be noted that tracking Part B costs to 

individual MA–EPs (physicians) is a 

critical part of determining the incentive 

payment due a qualifying MA 

organization (see 42 CFR 495.204(ff)). 

To the extent methodologies for 

estimating the portion of MA–EP 

compensation that is attributable to Part 

B professional services are used during 

the payment phase of the MA EHR 

Incentive Program, we believe these 

methodologies can also be successfully 

used during the adjustment phase of the 

Program. 

Comment: A commenter questioned if 

section 3401 of the Affordable Care Act 

market basket update adjustment due to 

changes in economy-wide productivity 

for FY 2012 and each subsequent fiscal 

year would be included, or if any other 

adjustment would be included in the 

market basket update rate used in the 

penalty adjustment formula. 

Response: Section 1853(m)(4)(B)(i) of 

the Act directs us to use the ‘‘number of 

the percentage point reduction effected 

under section 1886(b)(3)(B)(ix)(I) for the 

period.’’ That reduction is based off of 

a starting point of the applicable 

percentage increase otherwise 

applicable under clause (i), while 

mandating that this be ‘‘determined 

without regard to clause (viii), (xi), or 

(xii)’’ of section 1886(b)(3)(B) of the Act. 

Thus, the starting point for determining 

the percentage points by which the 

update is reduced is the applicable 

percentage increase in clause (i) of 

section 1886(b)(3)(B) of Act, before it 

has been further reduced for 

productivity (under clause (xi) for other 

statutory reductions (in clause (xii)), or 

for failure to report on certain measures 

(under clause (viii)). Currently, the 

applicable percentage increase in clause 

(i), before the other reductions have 

been made, is the market basket 

percentage increase for hospitals in all 

areas. Thus, such a market basket 

increase will be our starting point, and 

the percentage points by which that 

increase is reduced solely due to the 

application of EHR Program adjustments 

will be the point reduction we use in 

the MA formula. 

Comment: A commenter proposed an 

alternate method for computing the 

Medicare Hospital Expenditure 

Proportion based on what they believe 

is ‘‘consistent with fee-for-service 

hospital penalties.’’ 

Response: We believe our proposed 

method is consistent with the method 

the Medicare fee-for-service program 

will use to implement EHR adjustments 

for ‘‘subsection (d)’’ hospitals. 

Comment: One commenter expressed 

concern that CMS had proposed that 

payment adjustments would be based 

on an earlier payment period. 

Response: We believe the commenter 

is confused, as we did not propose a 

prior EHR reporting period for the MA 

program. 

We received no other comments on 

this section of the proposed rule. After 

consideration of the public comments 

received, we are finalizing these 

provisions as proposed with the one 

modification noted to § 495.211(c). 

6. Reconsideration Process for MA 

Organizations 

We proposed a reconsideration 

process in new section, § 495.213. We 

did not receive any comments on the 

proposed process. However, for the 

reasons stated in section II.D.5 of this 

final rule, we do not believe formal 

regulations for an informal 

reconsideration procedural rule are 

necessary and therefore we are not 

including this new section in this final 

rule. 

As noted in the proposed rule and as 

required by statute, our administrative 

reconsideration process would not 

permit administrative review of the 

standards and methods used to 

determine eligibility and payment (see 

sections 1853(l)(8) and (m)(6) of the Act, 

and § 495.212 of the regulations). 

However, it would allow a 

reconsideration of the application of 

such standards and methods, in certain 

circumstances. 

F. Revisions and Clarifications to the 

Medicaid EHR Incentive Program 

Unless otherwise specified, the 

changes discussed in this section of the 

rule will take effect upon publication of 

this final rule. 

1. Net Average Allowable Costs 

In this final rule, we are formalizing 

through rulemaking the guidance that 

was shared with state Medicaid 

Directors in a letter on April 8, 2011 

(available at: http://www.cms.gov/smdl/ 

downloads/SMD11002.pdf). These 

technical changes are required to 

implement section 205(e) of the 

Medicare and Medicaid Extenders Act 

of 2010 (Extenders Act, Pub. L. 111– 

309). The Extenders Act, enacted on 

mstockstill on DSK4VPTVN1PROD with RULES2

54120 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

December 15, 2010, amended sections 

1903(t)(3)(E) and 1903(t)(6)(B) of the 

Act. The amended sections change the 

requirements for an EP to demonstrate 

the ‘‘net average allowable costs,’’ the 

contributions from other sources, and 

the 15 percent provider contribution 

requirements to participate in the 

Medicaid EHR Incentive Payment 

Program. The Extenders Act provided 

that an EP has met this responsibility, 

as long as the incentive payment is not 

in excess of 85 percent of the net 

average allowable cost ($21,250 for first 

year payments). 

Before the Extenders Act, Medicaid 

EPs who wanted to participate in the 

EHR Incentive Payment Program were 

required to provide documentation of 

certain costs related to acquiring and 

implementing certified EHR technology. 

The Extenders Act amended the 

relevant statute by allowing for 

providers to simply document and attest 

that they have adopted, implemented, 

upgraded, or meaningfully used 

certified EHR technology, while 

allowing us to set these average costs. 

As a result, rather than requiring each 

EP to calculate the payments received 

from outside sources, each will use the 

average costs and contribution amount 

we established. After conducting a 

meta-analysis of existing data of an EP’s 

costs to adopt, implement, or upgrade 

certified EHR technology, we 

determined that average contributions 

from outside sources should not exceed 

$29,000. The documentation originally 

required by an EP to demonstrate that 

he or she contributed 15 percent (for 

example, $3,750 for year 1) of the ‘‘net 

average allowable costs’’ is also no 

longer needed. The Act now provides 

that an EP has met this responsibility as 

long as the incentive payment is not in 

excess of 85 percent of the net average 

allowable cost ($21,250). Given that this 

change is already in effect, we proposed 

to remove from the required content in 

the state Medicaid HIT Plan, the 

requirement that states describe the 

process in place to ensure that Medicaid 

EHR incentive payments are not paid at 

amounts higher than 85 percent of the 

net average allowable cost of certified 

EHR technology, as described in 

§ 495.332. 

We received no comments on our 

proposal to codify this already-existing 

policy, and we are finalizing our 

proposals without modification. 

TABLE E1—DETERMINATION OF NET AVERAGE ALLOWABLE COSTS FOR THE FIRST PAYMENT YEAR

First year 

variables 1 Amounts Prior to Extenders Act changes Currently 

Average Allowable 

Costs.

$54,000 ...................... Determined through a CMS meta-analysis, 

described in both the proposed rule (75 FR 

1844) and the final rule (75 FR 44314).

No change. 

Contributions from 

Other Sources.

Does not exceed 

$29,000.

Subtracted from Average Allowable Costs to 

reach ‘‘Net’’ Average Allowable Costs. An 

EP was required to show documentation of 

all contributions from certain other sources.

No documentation is needed. We have determined that average contributions do not exceed $29,000. 

Capped Amount of 

‘‘Net’’ Average Allowable Costs.

$25,000 ...................... Capped by statute and designated in CMS 

final rule.

No change. 

Contribution from the 

EP.

$3,750 ........................ An EP was required to demonstrate that he 

or she had contributed at least 15 percent 

of the net average allowable costs towards 

a certified EHR.

No documentation needed. Determined to 

have been met by virtue of EP receiving no 

more than $21,250 in the first payment 

year. 

Incentive payment 2 ..... $21,250 ...................... 85 percent of the Net Average Allowable 

Costs; determined through statute. An EP 

could receive less than this amount if he or 

she had contributions from other sources 

exceeding $29,000.

All EPs will receive the maximum incentive 

payment of $21,250, as all EPs will be determined to have contributions from other 

sources under $29,000. 

1These same concepts (but not figures) apply to the second through sixth years, integrating the figures from the Stage 1 final rule. Ultimately, 

the incentive paid in the second through sixth years is still the statutory maximum of $8,500. 2This figure is further reduced to two-thirds for pediatricians qualifying with reduced Medicaid patient volumes. This is described at 42 CFR 

495.310. 

2. Definition of Adopt, Implement 

Upgrade 

We are adding clarifying language that 

maintains our policy that to qualify for 

an AIU payment, a provider must adopt, 

implement or upgrade to certified EHR 

technology that would allow that 

provider to qualify as a meaningful user. 

Our regulation has always defined 

certified EHR technology by reference to 

the ONC definition at 45 CFR 170.102, 

and ONC’s definition of certified EHR 

technology has consistently required the 

technology to support meaningful use. 

While ONC is changing the definition of 

certified EHR technology, we do not 

believe this change would allow a 

provider to receive an incentive for 

technology that could not support 

meaningful use (that is for purchasing 

only ‘‘Base EHR’’ technology). 

Nevertheless, in order to be absolutely 

clear in our regulations, we are 

amending them to ensure that providers 

do not receive Medicaid incentives for 

adopting technology that would not 

allow them to demonstrate meaningful 

use. 

3. Eligibility Requirements for 

Children’s Hospitals 

We proposed to revise the definition 

of a children’s hospital in § 495.302 to 

also include any separately certified 

hospital, either freestanding or hospital 

within hospital that predominately 

treats individuals under 21 years of age; 

and does not have a CMS certification 

number (CCN) because they do not serve 

any Medicare beneficiaries but has been 

provided an alternative number by CMS 

for purposes of enrollment in the 

Medicaid EHR Incentive Program. We 

will provide future guidance on how to 

obtain these alternative numbers. 

The only comments we received on 

this proposal were favorable. We are 

finalizing these policies as proposed. 

Guidance to these hospitals and the 

states on enumeration and determining 

eligibility is also forthcoming. 

4. Medicaid Professionals Program 

Eligibility 

Section 1903(t) of the Act authorizes 

Medicaid payments to encourage the 

adoption and use of certified EHR 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54121 

technology, and places Medicaid patient 

volume requirements on EPs to qualify 

for such payments under the Medicaid 

program. Patient volume requirements 

ensure that Medicaid funding is used to 

encourage the adoption and use of 

technology specifically to benefit the 

care of Medicaid populations. 

Therefore, we proposed that at least one 

of the clinical locations used for the 

calculation of an EP’s patient volume 

have CEHRT during the payment year 

for which the EP is attesting to 

adoption, implementation or upgrade or 

meaningful use. This will ensure that 

Medicaid funding goes to EPs using 

CEHRT to improve Medicaid patients’ 

care. 

The only comments that we received 

on this proposal were in support of the 

proposal. For the reasons explained in 

the proposed rule, we are finalizing this 

policy as proposed. We have amended 

§ 495.304 and § 495.332 accordingly. 

a. Calculating Patient Volume 

Requirements 

We proposed to revise § 495.306(c) to 

allow states the option for their 

providers to calculate total Medicaid 

encounters or total needy individual 

patient encounters in any 

representative, continuous 90-day 

period in the 12 months preceding the 

EP or eligible hospital’s attestation. This 

option will be in addition to the current 

regulatory language that bases patient 

volume on the prior calendar or fiscal 

year. We believe this adjustment will 

provide greater flexibility in eligible 

providers’ patient volume calculations. 

Likewise, we proposed to revise 

§ 495.306(d)(1)(i)(A) to allow for the 

calculation of the total Medicaid 

patients assigned to the EP’s panel in 

any representative, continuous 90-day 

period in either the preceding calendar 

year, as is currently permitted, or in the 

12 months preceding the EPs’ 

attestation, when at least one Medicaid 

encounter took place with the Medicaid 

patient in the 24 months prior to the 

beginning of the 90-day period. We also 

proposed to revise § 495.306(d)(1)(ii)(A) 

accordingly, so that the numerator and 

denominator are using equivalent 

periods. We proposed conforming 

changes to § 495.306(d)(2)(i) and (ii) for 

needy individual patient volume. We 

proposed changing the period during 

which the encounter must take place 

from 12 months to 24 months to account 

for new clinical guidelines from the U.S. 

Preventive Health Services Task Force 

that allow greater spacing between some 

wellness visits. Therefore, in order for a 

patient to be considered ‘‘active’’ on a 

provider’s panel, we proposed 24 

months is more appropriate. This 

change is also in order to be consistent 

with the proposed Stage 2 meaningful 

use measure for patient reminders sent 

to ‘‘active patients.’’ 

The only comments we received on 

this proposal were supportive. For the 

reasons explained in the proposed rule, 

we are finalizing this policy as 

proposed. We note that as explained in 

the proposed rule, this will be an option 

for states to implement at their 

discretion. States must seek prior 

approval from CMS via an amendment 

to their state Medicaid HIT Plan before 

implementing this change. 

We also proposed to expand the 

definition of ‘‘encounter’’ to include any 

service rendered on any one day to an 

individual enrolled in a Medicaid 

program. We explained that such a 

definition will ensure that patients 

enrolled in a Medicaid program are 

counted, even if the Medicaid program 

did not pay for the service (because, for 

example, a third party payer paid for the 

item or service, or the service is not 

covered under Medicaid). We also 

explained that the definition would 

include encounters for patients who are 

Title XIX eligible and who meet the 

definition of ‘‘optional targeted low 

income children’’ under section 

1905(u)(2) of the Act. Thus, individuals 

in Title XXI-funded Medicaid 

expansions (but not separate CHIPs) 

could be counted in providers’ patient 

volume calculations. We stated that this 

approach is consistent with existing 

policies that provide Title XIX 

protections to children enrolled in Title 

XXI-funded Medicaid expansions. 

In the proposed rule, we noted that as 

of 2010, 33 states have Title XXI 

Medicaid expansions via approved state 

plan amendments. Therefore, under our 

proposed policy, providers in those 

states would be able to include 

encounters with individuals in such 

expansions in their patient volume 

calculation for purposes of this program. 

In 2010, over 2.1 million children were 

covered in Medicaid expansion 

programs. We stated that our proposed 

change would likely increase the 

number of eligible providers who 

qualify for the Medicaid EHR Incentive 

Program, particularly those serving 

children because it allows states to 

create a larger base of Medicaid patients 

to be counted toward the patient volume 

requirements than existed under the 

Stage 1 rule. 

Comment: Some commenters were 

concerned about verifying patient 

volume requirements for patients seen 

for a service where Medicaid did not 

pay for all or part of the service. 

Commenters asked CMS to clarify the 

prepayment audit expectations of states 

with this broader definition. 

Response: This final rule does not 

change states’ obligations to complete 

due diligence to verify all eligibility 

criteria, including patient volume. 

Existing subregulatory guidance is 

available to states to assist in developing 

audit processes. We encourage states to 

take advantage of those materials, 

guidance, and technical assistance 

resources that we have made available 

to support their auditing activities. 

Comment: Commenters, while 

supportive of these changes, inquired 

whether these changes would be 

retroactive and affect payments already 

disbursed. They asked, for example, 

whether EPs who attested to Medicare 

for CY 2011 would be able to refund 

Medicare incentive payments and 

qualify for the Medicaid payment; or 

whether pediatricians who received the 

incentive for a patient volume of 20 

percent would be able to receive a 

replacement payment associated with 

the 30 percent patient volume. 

Response: These changes are not 

retroactive. Patient volume 

requirements for 2011 and 2012 are not 

affected by these changes. Eligibility for 

the program is determined at the time of 

attestation and prior to payment. States 

should implement this new definition of 

an encounter no later than 6 months 

after this rule is published and only for 

providers attesting for the 2013 program 

year and subsequent program years. In 

no event will this definition apply to 

attestations for the 2012 program year. 

Comment: Commenters also inquired 

whether these new eligibility changes 

meant that an EP or eligible hospital 

denied an incentive payment because of 

failure to satisfy patient volume 

requirements could reapply in the same 

program year. 

Response: As explained in our 

response to the previous comment, 

these changes would not be retroactive. 

Existing rules permit an EP or eligible 

hospital to reapply if they fail to meet 

the requirements for an incentive 

payment. If a provider fails to meet the 

requirements in 2013 before their state 

has implemented this change, they may 

then reapply after the change is made to 

their state’s systems. Additionally, an 

EP or eligible hospital denied eligibility 

in a previous year is always permitted 

to reapply for a subsequent year (subject 

to rules for EPs switching programs as 

explained in § 495.10). 

For the reasons explained in the 

proposed rule, and because this change 

will help more Medicaid providers 

qualify for the program, we are 

finalizing this policy as proposed. The 

expanded definition of encounter will 

mstockstill on DSK4VPTVN1PROD with RULES2

54122 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

include individuals enrolled in 

Medicaid who had a billable service on 

any one day during the 90-day patient 

volume timeframe. 

In our proposed rule, we also clarified 

that we understand that multiple 

providers may submit an encounter for 

the same individual. For example, it 

may be common for a PA or NP to 

provide care to a patient, then a 

physician to also see, or invoice for 

services to that patient. We explained 

that it is acceptable in these and similar 

circumstances to count the same 

encounter for multiple providers for 

purposes of calculating each provider’s 

patient volume when the encounters 

take place within the scope of practice. 

We did not receive any comments on 

this clarification and retain it for the 

final rule. 

b. Practices Predominantly 

Similar to our proposed revisions for 

patient volume, we proposed to revise 

the definition of ‘‘practices 

predominantly’’ at § 495.302 in order to 

provide more flexibility for eligible 

professionals and states. A state could 

choose to allow EPs to use either: (1) 

The most recent calendar year; or (2) the 

most recent 12 months prior to 

attestation. Also, as with the previously 

noted patient volume changes, these 

‘‘practices predominantly’’ changes are 

not retroactive. Patient volume 

requirements for 2011 and 2012 are not 

affected by these changes. States should 

implement this new definition of an 

encounter no later than 6 months after 

this rule is published and only for 

providers attesting to meeting program 

requirements for the 2013 program year 

and subsequent program years. In no 

event will this definition apply to 

attestations for the 2012 program year. 

Comment: Some commenters— 

commenting on the patient volume 

changes in § 495.306, the ‘‘practice 

predominantly’’ changes in § 495.302, 

and the revised definition of 

encounter—expressed concerns about 

the system challenges associated with 

such changes. They requested that CMS 

consider the burden on state systems to 

implement these changes. 

Response: We recognize that system 

changes must be considered when 

enacting or revising policies. However, 

we note that much of what we have 

proposed would be optional for states, 

while some would be required. We 

believe our final rule strikes a balance 

between optional and required policies 

for states, and providing 6 months to 

make systems changes balances 

implementation timelines with the 

overall goal to promote EHR adoption 

through the Medicaid EHR Incentive 

Program. We note that states receive 90 

percent Federal matching funds for 

administrative costs associated with the 

EHR Incentive Program. 

Comment: Although we did not make 

any proposals on the subject, some 

commenters requested a more 

prescriptive definition of pediatrician be 

provided to the states that includes 

pediatric ophthalmologists. 

Response: We did not make any 

proposals on the definition of 

pediatrician. This final rule does not 

change the previous flexibility that 

states had to define pediatrician. In 

some states, pediatric ophthalmologists 

are eligible for the program, but that is 

entirely dependent on how the state has 

chosen to define pediatrician. This 

suggestion is also outside the scope of 

this rulemaking. 

After consideration of the public 

comments received, we are finalizing 

the revised definition of ‘‘practices 

predominantly’’ at § 495.302 as 

proposed; this revised definition is 

applicable to providers attesting to 

meeting program requirements for the 

2013 program year and subsequent 

program years. 

5. Medicaid Hospital Incentive Payment 

Calculation 

a. Discharge Related Amount 

In order to ensure that Medicaid 

regulations are consistent with 

Medicare, we proposed that the 

Medicaid calculation should be 

consistent with the Medicare 

calculation found in § 495.104(c)(2). Our 

current regulations at 

§ 495.310(g)(1)(i)(B) require the use of 

the ‘‘12-month period selected by the 

state, but ending in the Federal fiscal 

year before the hospital’s fiscal year that 

serves as the first payment year.’’ We 

also published a tip sheet with 

additional guidance on the Medicaid 

hospital incentive payment calculation, 

which can be found at: (https://

www.cms.gov/MLNProducts/down

loads/Medicaid_Hosp_Incentive_

Payments_Tip_Sheets.pdf). However, 

some hospitals may not have a full 12 

months of data ending with the Federal 

fiscal year immediately preceding the 

first payment year, or they may have a 

slightly older 12-month period that 

could be used. Therefore, we have 

revised our regulations at 

§ 495.310(g)(1)(i)(B) to allow states to 

use, for the purpose of calculating the 

discharge related amount, and other 

determinations (such as inpatient bed 

days), the most recent continuous 12- 

month period for which data are 

available prior to the payment year. If 

such 12-month period is a cost report, 

it should be one, single 12-month cost 

reporting period (and not a 

consolidation of two separate cost 

reporting periods). If it is an alternative 

source different from the cost report, we 

will rely on the state to ensure that the 

source is an appropriate source, and that 

the period is a continuous 12 months, 

and that the state is using the most 

recent data that are available. States 

should implement these changes only 

for hospitals that begin participation in 

the program starting in federal fiscal 

year 2013 or subsequent federal fiscal 

years. Hospitals that began participation 

before federal fiscal year 2013 must use 

discharge data from the hospital fiscal 

year that ends during the federal fiscal 

year prior to the hospital fiscal year that 

serves as the first payment year. 

Comment: Commenters were 

concerned that hospitals may not have 

a full 12 months of data available 

ending with the Federal fiscal year 

immediately preceding the first 

payment year, thus restricting hospitals 

participation in the program. 

Response: We appreciate the 

commenters concern; however, the 

change in regulatory language does not 

require hospitals to use data 

immediately preceding the first 

payment year, but rather the most recent 

12 consecutive months of data available 

to the hospital prior to the payment 

year. The intent of this regulatory 

change was to encourage timely 

participation in the program. For the 

base year, the former policy required 

hospitals to initiate participation using 

a 12-month period ending in the Federal 

fiscal year before the hospital’s fiscal 

year that serves as the first payment 

year. In recognition of this challenge, we 

are changing the regulation at 

§ 495.310(g)(1)(i)(B) to allow hospitals to 

use, for purposes of determining the 

base year for the Medicaid incentive 

payment calculation, the most recent 

continuous 12-month period for which 

data are available prior to the payment 

year. Only those hospitals that begin 

participation in program year 2013 and 

beyond will be affected by this change. 

Hospitals that began participation in the 

program before 2013 will not have to 

adjust previous calculations. 

Comment: A commenter suggested 

that ‘‘the most recent data that are 

available’’ is ambiguous. Hospital cost 

report data are subject to significant 

audit and adjustments subsequent to 

their submission to the state, so the 

definition of ‘‘available’’ has a large 

impact on the reliability of the data used 

to calculate the incentive payment 

amount. The commenter noted that the 

state and CMS have a strong interest in 

ensuring that the data used to calculate 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54123 

the hospital incentive payment is 

accurate, defensible, and final, and the 

use of data that are not properly audited 

would create a significant potential for 

issuing incentive payments that would 

later need to be adjusted. The 

commenter suggested that CMS clarify 

‘‘the most recent data that are available’’ 

means the most recent data that, in the 

judgment of the state, are properly 

audited and finalized. 

Response: We appreciate the 

commenters concern; however, we do 

not agree that the data needs to be 

audited and finalized in order to be 

used for the incentive payment 

calculation. It is our expectation that the 

hospital incentive payment is calculated 

using the most accurate data available at 

the time of calculation and it is the 

responsibility of the state to make the 

determination of which source is most 

accurate. We do not restrict data 

sources, as we believe the states are best 

positioned to balance the accuracy and 

timeliness of the data available. 

Medicare pays hospitals using 

preliminary, filed, cost report data and 

reconciles payment when the data is 

audited and finalized. Similarly, we 

allow states to adjust calculations and 

reconcile payments when audited and 

finalized data are available. State policy 

changes or proposals regarding 

reconciliation of hospital incentive 

payments must be reflected in the state’ 

Medicaid Health Information 

Technology Plan (SMHP) and must be 

reviewed and approved by CMS. 

b. Acute Care Inpatient Bed Days and 

Discharges for the Medicaid Share and 

Discharge-Related Amount 

In order to ensure that the regulations 

accurately reflect our current policy, we 

proposed to amend the hospital 

payment regulations at 

§ 495.310(g)(1)(i)(B) and (g)(2) to 

recognize that only acute-care 

discharges and bed-days are included in 

our calculations. We currently require 

that only discharges from the acute care 

part of the hospital may be counted in 

both the discharge-related amount and 

the Medicaid share. For example, in 

response to a frequently asked question 

(https://questions.cms.gov, FAQ #2991), 

we explained that nursery days and 

nursery discharges (for newborns) could 

not be counted in both the Medicare and 

Medicaid EHR incentive programs. We 

stated: ‘‘[N]ursery days and discharges 

are not included in inpatient bed-day or 

discharge counts in calculating hospital 

incentives * * * because they are not 

considered acute inpatient services 

based on the level of care provided 

during a normal nursery stay.’’ 

Such regulatory amendments do not 

represent a change in policy but rather 

a clarification of existing policy. The 

Medicaid share will count only those 

days that will count as inpatient-bed 

days for Medicare purposes under 

section 1886(n)(2)(D) of the Act. (See 75 

FR 44498). In addition, in determining 

the overall EHR amount, section 

1903(t)(5)(B) of the Act requires the use 

of applicable amounts specified in 

section 1886(n)(2)(A) of the Act. 

Comment: A commenter expressed 

concern with the perceived removal of 

newborn nursery days from the hospital 

calculation. The commenter stated that 

this would create a disadvantage for 

some hospitals. 

Response: We wish to be clear our 

policy on nursery days is not a new 

policy or a proposed change. The 

change in regulatory language on the 

use of acute inpatient bed days is to 

ensure that our regulation text clearly 

reflects our existing policy. The 

requirement to exclude non-acute 

inpatient bed days from the incentive 

payment calculation is consistent with 

both the Medicare and Medicaid 

regulations under Stage 1, as stated in 

our frequently asked questions 

(available at https://questions.cms.gov, 

FAQ #2991). In that FAQ, we explain 

that the Medicaid payment to hospitals 

is based largely on the method that 

applies to Medicare incentive payments. 

Because such nursery discharges and 

bed days would not be included in the 

Medicare calculation, and because the 

Medicaid statute incorporates Medicare 

concepts, they also would not be 

counted in the Medicaid formula. We 

are simply adding additional language 

to clarify that all bed days and 

discharges used in the calculation are 

strictly limited to the acute-inpatient 

portion of the hospital. All hospitals 

will continue to exclude nonacute bed 

days and discharges from the hospital 

incentive calculation. 

Comment: A commenter suggested 

that CMS clarify and inform states and 

providers that neonatal intensive care 

days are considered acute, and should 

be included in the Medicaid hospital 

incentive payment calculation. 

Response: We appreciate the 

commenter’s suggestion and recognize 

that neonatal intensive care days are 

considered acute inpatient services that 

should be included in the hospital 

incentive calculation. 

c. Hospitals Switching States 

There may be a situation where a 

hospital changes participation in one 

state Medicaid EHR incentive program 

to participation in another state. We are 

clarifying that in no case will a hospital 

receive more than the aggregate 

incentive amount calculated by the state 

from which the hospital initiated 

participation in the program. Section 

495.310(e) requires a hospital to choose 

only one state per payment year from 

which to receive an incentive payment. 

Additionally, § 495.310(f)(2) states that 

in no case can total incentives received 

by a hospital exceed the aggregate EHR 

incentive amount, as calculated in 

§ 495.310(g). 

In this scenario, both states will be 

required to work together to determine 

the remaining payments due to the 

hospital based on the aggregate 

incentive amount and incentive 

amounts already paid. The hospital will 

then assume the second state’s payment 

cycle, less the money paid from the first 

state. States should consult with CMS 

before addressing this specific scenario. 

We did not receive any comments and 

we are finalizing these provisions as 

proposed for the reasons provided in the 

proposed rule. 

6. Hospital Demonstrations of 

Meaningful Use—Auditing and Appeals 

We proposed revisions to § 495.312 

under which states would have the 

option for CMS to conduct audits and 

handle any subsequent appeals of 

whether eligible hospitals are 

meaningful EHR users, on the state’s 

behalf. (We note that the preamble text 

(at 77 FR 13788) did not reflect the 

proposed regulations.) We also 

proposed revisions to the SMHP 

requirements in § 495.332 by adding a 

new paragraph (g) that would allow the 

state, at the state’s option, to include a 

signed agreement if the state has opted 

for CMS to conduct such audits and 

appeals. Under these proposals, the 

state electing the option would be 

required to (1) designate CMS to 

conduct all audits and appeals of 

eligible hospitals’ meaningful use 

attestations; (2) be bound by the audit 

and appeal findings; (3) perform any 

necessary recoupments arising from the 

audits; and (4) be liable for any FFP 

granted the state to pay eligible 

hospitals that, upon audit (and any 

subsequent appeal) are determined not 

to have been meaningful EHR users. 

Finally, we proposed to revise our 

regulations at § 495.370 to make clear 

that results of any adverse CMS audits 

(for states that have made the election) 

would be subject to the CMS 

administrative appeals process and not 

the state appeals process. 

Most hospitals are eligible for both 

Medicare and Medicaid incentive 

payments, submit attestations on 

meaningful use to us under the 

Medicare attestation system, and, if 

mstockstill on DSK4VPTVN1PROD with RULES2

54124 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

successful, under the authority of 

section 1903(t)(8) of the Act, are deemed 

to have met the meaningful use 

requirements for Medicaid. Thus, we 

believe the revisions that were included 

in our proposed regulation text would 

provide states with the option to 

alleviate their burden to develop an 

audit process for hospitals and then 

perform audits on hospitals’ meaningful 

use attestations. Because the regulation 

text made the CMS audits and appeals 

a state option, no state would be 

required to delegate the responsibility to 

CMS. 

As discussed in the proposed rule 

preamble, many states indicated an 

interest in having CMS audit all 

hospitals’ meaningful use attestations, 

and a majority of states have two or 

fewer Medicaid-only hospitals applying 

for incentive payments. Therefore, a 

state option for CMS to conduct audits 

and appeals will leverage the resources 

already devoted to auditing the vast 

majority of hospitals that are eligible for 

both incentive programs while retaining 

state flexibility to perform their own 

meaningful use audits and appeals for 

the Medicaid-only hospitals in states 

that choose to do so. (In cases where a 

state has made the election, meaningful 

use attestation data collected by states 

for the Medicaid-only eligible hospitals 

would be shared with our auditors to 

enable this process). 

As discussed in the proposed rule, we 

note that this policy does not extend to 

Medicaid eligible professionals, given 

the anticipated large number of 

Medicaid eligible professionals 

demonstrating meaningful use solely 

under the Medicaid program. In 

addition, states that opt for CMS to 

conduct audits and appeals will remain 

responsible for auditing all other aspects 

of eligibility for both EPs and eligible 

hospitals for incentive payments, 

including, but not limited to—(1) adopt, 

implement or upgrade; (2) patient 

volume; (3) average stay length; and (4) 

calculation of payment amounts. States 

will also remain responsible for auditing 

EPs for compliance with meaningful use 

of certified EHR technology. 

We did not receive any comments on 

either the preamble or the regulation 

text, and we are finalizing the proposed 

regulations for the reasons discussed 

previously. 

7. State Flexibility for Stage 2 of 

Meaningful Use 

We proposed to offer states flexibility 

with the public health measures in 

Stage 2, similar to that of Stage 1, 

subject to the same conditions and 

standards as the Stage 1 flexibility 

policy. This applies to the public health 

measures as well as the measure to 

generate lists of specific conditions to 

use for quality improvement, reduction 

of disparities, research or outreach. In 

addition, we proposed that whether 

moved to the core or left in the menu, 

states could also specify the means of 

transmission of the data or otherwise 

change the public health measure, as 

long as it does not require EHR 

functionality above and beyond that 

which is included in the ONC EHR 

certification criteria as finalized for 

Stage 2 of meaningful use. 

We did not receive any comments on 

this policy. Although § 495.316(d)(2) 

already contains provisions for state 

flexibility, there are new public health 

measures for Stage 2 of meaningful use 

and some of the descriptions are 

changing slightly for Stage 2. Therefore, 

in this final rule, we have amended 

§ 495.316(d)(2) to ensure that the 

objectives for which states will have 

flexibility are adequately represented for 

both Stage 1 and Stage 2. 

8. State Medicaid Health Information 

Technology Plan (SMHP) and 

Implementation Advance Planning 

Document (IAPD) 

a. Frequency of Health Information 

Technology (HIT) Implementation 

Advanced Planning Document (IAPD) 

Updates 

We proposed to revise § 495.342 

regarding the frequency of HIT IAPD 

updates. Rather than requiring each 

state to submit an annual HIT IAPD 

within 60 days from the HIT IAPD 

approved anniversary date, we proposed 

to require that a state’s annual IAPD 

(also known as an IAPD Update (IAPD– 

U)) be submitted a minimum of 12 

months from the date of the last CMS 

approved HIT IAPD. For example, if the 

initial HIT IAPD or previous IAPD–U 

was approved by CMS effective July 25, 

2011, the state must submit their next 

HIT IAPD–U on or before July 25, 2012. 

Therefore, annual IAPD updates are 

required only if the state has not 

submitted an IAPD–U in the past 12 

months, rather than on a fixed annual 

basis as currently reflected in § 495.342. 

We did not propose to change the 

requirements of the circumstances of 

‘‘as needed’’ IAPD updates as defined by 

§ 495.340. 

Comment: Comments received on the 

change to the annual HIT IAPD 

submission deadline requirements were 

supportive of the change and the idea of 

reducing the administrative burden on 

states. A commenter requested that the 

phrase, ‘‘minimum of 12 months’’ be 

changed to ‘‘maximum of 12 months.’’ 

Response: We believe that a better 

solution would be to remove the word 

‘‘minimum’’ from the text so it reads, 

‘‘Each state is required to submit the 

HIT IAPD Updates 12 months from the 

date of the last CMS approved HIT IAPD 

and must contain the following.’’ This 

more accurately describes the intent to 

clarify the timeline in which the state 

must submit the annual HIT IAPD. 

Therefore, § 495.342 is revised 

accordingly. 

b. Requirements of States Transitioning 

From HIT Planning Advanced Planning 

Documents (P–APDs) to HIT IAPDs 

We proposed the following process 

for states that have an approved HIT P– 

APD and are ready to submit a HIT 

IAPD for review and approval. We do 

not allow states to have more than one 

HIT Advance Planning Document (APD) 

open at a time. If planning activities 

from the HIT P–APD have been 

completed, in their HIT IAPD the state 

should explain in a narrative format that 

all planning activities have been 

completed and the planning advanced 

planning document can be closed out. If 

there are HIT planning activities that the 

state determines will continue during 

the implementation period, these 

planning activities must be included as 

line items within the HIT IAPD budget. 

We did not receive any comments on 

this discussion of the process states 

should use. We will use the previouslydescribed process for states 

transitioning from a HIT P–APD to a 

HIT IAPD. 

III. Waiver of Delayed Effective Date 

We ordinarily provide a 60-day delay 

in the effective date of the provisions of 

a major rule in accordance with the 

Administrative Procedure Act (APA) (5 

U.S.C. 553(d), which requires a 30-day 

delayed effective date, and the 

Congressional Review Act (5 U.S.C. 

801(a)(3), which requires a 60-day 

delayed effective date for major rules. 

However, we can waive the delay in 

effective date if the Secretary finds, for 

good cause, that such delay is 

impracticable, unnecessary, or contrary 

to the public interest, and incorporates 

a statement of the finding and the 

reasons in the rule issued under 5 

U.S.C. 553(d)(3) and 5 U.S.C. 808(2). 

The Secretary finds that good cause 

exists to make certain regulatory 

provisions effective upon publication in 

the Federal Register. 

Our revisions to § 495.6(f) and (g) 

change certain criteria for meaningful 

use beginning with FY 2013. Some 

eligible hospitals and CAHs will begin 

their EHR reporting period using the 

criteria under § 495.6(f) and (g) 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54125 

beginning October 1, 2012. All of these 

changes are optional and are meant to 

provide greater flexibility in meeting 

these criteria. Because these revisions 

relieve a restriction on eligible hospitals 

and CAHs, a waiver of the delayed 

effective date is in order. It is both 

unnecessary to delay the effective date, 

and in the public’s best interest to waive 

the delay in effective date for these 

changes. Furthermore, ensuring that 

these provisions are effective beginning 

with FY 2013 would mitigate any 

disadvantage experienced by eligible 

hospitals and CAHs beginning their 

EHR reporting periods at the beginning 

of the fiscal year, because it would 

allow them to use these revised criteria 

at the beginning of such period. Our 

revisions to § 495.6(f) include 

eliminating the reporting of clinical 

quality measures as a separate objective 

of meaningful use and instead including 

this reporting requirement as part of the 

definition of ‘‘meaningful EHR user’’ 

under § 495.4. Accordingly, the delayed 

effective date must also be waived with 

regard to the definition of ‘‘meaningful 

EHR user’’ under § 495.4 and the 

revisions to § 495.8. To allow these 

provisions to take effect with the 

beginning of FY 2013, it is impracticable 

to delay the effective date, which would 

occur after the beginning of the fiscal 

year. 

We have also made a technical 

correction to § 495.102(c) so that it 

correctly reflects the policy we adopted 

in the Stage 1 final rule for EPs who 

predominantly furnish services in a 

geographic HPSA. This change is 

technical in nature and merely codifies 

our existing policy. Retaining current 

regulatory language would allow an 

error to persist. Therefore, it is 

unnecessary, impracticable, and 

contrary to the public interest to delay 

the effective date of this codification. 

We are also waiving the delay in 

effective date for all of the changes we 

are making to subpart D of part 495. 

Some of these changes either codify or 

more clearly specify already existing 

policy (deletions of § 495.310(a)(1)(ii), 

§ 495.310(a)(2)(ii), and § 495.332(d)(9) to 

reflect the existing policy on net average 

allowable cost under the Medicare and 

Medicaid Extenders Act of 2010; 

changes to § 495.310(g) to clarify that 

the rules are for ‘‘acute-care inpatient 

discharges’’ and ‘‘acute care inpatient 

bed-days’’; changes to § 495.310 to 

clarify policy on hospitals switching 

states). Therefore, it is unnecessary, 

impracticable, and contrary to the 

public interest to delay the effective 

date of these provisions as they are 

already in effect as CMS policies. 

Others of these changes merely 

provide states or eligible providers with 

additional flexibility to adopt policies 

that will be of benefit to the states or 

providers, thus relieving a restriction 

(§ 495.302 change in definition for 

children’s hospital and practices 

predominantly; § 495.304 regarding 

allowing EPs and eligible hospitals to 

include individuals enrolled in a 

Medicaid program in 2013; changes to 

§ 495.306 regarding additional 

flexibility for determining patient 

volume in 2013; changes to § 495.312 

and § 495.332(c) and (g) and § 495.370 

regarding additional options for states in 

conducting audits and appeals of 

eligible hospitals’ meaningful use; and 

changes to § 495.342 adding flexibility 

on submission of the HIT IAPD). These 

changes will be in the public interest of 

states or eligible providers or both, 

because they provide additional 

flexibility allowing states to relieve their 

burdens, or allowing additional 

providers to qualify for Medicaid 

incentives under the program. It is 

important that these changes be in place 

as soon as possible, and especially as of 

October 1, 2012 for eligible hospitals 

beginning their fiscal years. Therefore, a 

waiver in the delay in the effective date 

is both impracticable and contrary to the 

public interest, and the Secretary finds 

good cause not to delay the effective 

date of these provisions. 

The final change to subpart D (in 

§ 495.304(f) and § 495.332(b)(6)) applies 

to EPs, who will not begin payment year 

2013 until the beginning of the calendar 

year in any case. However, in the 

interest of ensuring that states have a 

reasonable opportunity to amend their 

SMHPs and to ensure consistency in 

effective date for the entire subpart it is 

in the public interest to waive the delay 

in effective date for these changes as 

well. Again, the effect on EPs would not 

take place until January of 2013 in any 

case—well after a 60-day delay has 

occurred. 

For all these reasons, we believe that 

a 60-day delay in the effective date of 

the previously discussed provisions 

would be unnecessary, impracticable, 

and contrary to the public interest. 

Therefore, we find good cause for 

waiving the 60-day delay in the effective 

date for these provisions and making the 

provisions effective upon publication. 

IV. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 30- 

day notice in the Federal Register and 

solicit public comment before a 

collection of information requirement is 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. In order to fairly evaluate 

whether an information collection 

should be approved by OMB, section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires that we 

solicit comment on the following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

The following is a discussion of the 

requirements we believe are subject to 

the PRA and collection of information 

requirements (ICRs) as a result of this 

final rule. This analysis finalizes our 

projections which were proposed in the 

March 7, 2012 Federal Register (77 FR 

13790 through 13800) in which we 

proposed a revision to the existing PRA 

package approved under OMB control 

number 0938–1158. The projected 

numbers of EPs, eligible hospitals, 

CAHs, MA organizations, MA EPs, and 

MA-affiliated hospitals are based on the 

numbers used in the impact analysis 

assumptions as well as estimated federal 

costs and savings in section V. of this 

final rule. The actual burden will 

remain constant for all of Stage 2 as EPs, 

eligible hospitals, and CAHs will only 

need to attest that they have 

successfully demonstrated meaningful 

use one time per year. The only variable 

from year to year in Stage 2 will be the 

number of respondents, as noted in the 

impact analysis assumptions. For the 

purposes of this analysis, we are 

focusing only on 2014, the first year in 

which a provider may participate in 

Stage 2 of the Medicare EHR Incentive 

Program. We do not believe the burden 

for EPs, eligible hospitals, and CAHs 

participating in Stage 1 prior to 2014 

will be different from the agency 

information collection activities (75 FR 

65354) based on this final rule. 

Beginning in 2012, Medicare EPs, 

eligible hospitals, and CAHs have the 

option to electronically report their 

clinical quality measures through the 

respective electronic reporting pilots. 

The burden for the EP pilot is discussed 

in the CY 2012 Medicare PFS final rule 

with comment period (76 FR 73450 

through 73451). For eligible hospitals 

and CAHs, the burden is discussed in 

the CY 2012 OPPS final rule with 

comment period (76 FR 74489 through 

74492). 

mstockstill on DSK4VPTVN1PROD with RULES2

54126 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

A. ICR Regarding Demonstration of 

Meaningful Use Criteria (§ 495.6 and 

§ 495.8) 

In § 495.6 of the proposed rule, we 

proposed that to successfully 

demonstrate meaningful use of CEHRT 

for Stage 2, an EP, eligible hospital or 

CAH (collectively referred to as 

‘‘provider’’ in this section) must attest, 

through a secure mechanism in a 

specified manner, to the following 

during the EHR reporting period: (1) 

The provider used CEHRT and specified 

the technology was used; and (2) the 

provider satisfied each of the applicable 

objectives and associated measures in 

§ 495.6. In § 495.8, we proposed that a 

provider must also successfully report 

the clinical quality measures selected by 

CMS to CMS or the states, as applicable. 

We assumed that the CEHRT adopted by 

the provider would capture many of the 

objectives and associated measures and 

generate automated numerator and 

denominator information where 

required, or generate automated 

summary reports. We also expect that 

the provider would enable the 

functionality required to complete the 

objectives and associated measures that 

require the provider to attest that they 

have done so. 

We proposed that EPs would be 

required to report on a total of 17 core 

objectives and associated measures, 3 of 

5 menu set objectives and associated 

measures, and 12 ambulatory clinical 

quality measures. We estimated the total 

average annual cost burden for all 

198,912 nonhospital-based EPs who 

may attest in 2014 to be $186,098,885 

(198,912 EPs × 10 hours 24 minutes × 

$89.96 (mean hourly rate for physicians 

based on May 2010 Bureau of Labor 

Statistics (BLS) data)). We proposed that 

eligible hospitals and CAHs would be 

required to report on a total of 16 core 

objectives and associated measures, 2 of 

the 4 menu set objectives and associated 

measures, and 24 clinical quality 

measures. We estimated the total annual 

cost burden for all eligible hospitals and 

CAHs to attest to EHR technology, 

meaningful use core set and menu set 

criteria, and electronically submit the 

clinical quality measures would be 

$2,375,564 (4,993 eligible hospitals and 

CAHs × $62.23 (12 hours 14 minutes × 

$62.23 (mean hourly rate for lawyers 

based on May 2010 BLS) data)). 

Comment: A commenter suggested 

CMS account for Web site 

responsiveness when estimating the 

burden for providers as they enter 

attestation data. The commenter noted 

that the Web site would take several 

minutes after entering data until the 

next page would become available. 

Response: We cannot forecast 

technical difficulties with our Web sites, 

but strive to maintain a high level of 

responsiveness. 

Comment: Some commenters 

suggested CMS underestimated the 

amount of time it takes providers to 

attest that they have successfully 

demonstrated meaningful use. They 

noted that providers see attestation as 

more than just reporting their data at the 

end of the reporting period, rather, a 

process that is continuously monitored 

throughout that time. Others noted that 

the operational burden that providers 

encounter on a per-patient basis will 

increase significantly in Stage 2. 

Response: We appreciate the public 

comments on this burden analysis. 

However, this analysis specifically 

reflects the amount of time we estimate 

providers will take to prepare and report 

their meaningful use data through the 

Medicare and Medicaid EHR Incentive 

Programs Registration and Attestation 

System. We cannot account for 

individual providers’ workflows or 

training needs to participate in these 

programs. 

After consideration of the public 

comments received, we are finalizing 

these burden estimates as proposed but 

have updated them to reflect policy 

changes implemented through this final 

rule. 

In this final rule, there are 13 core 

objectives and up to 3 menu set 

objectives that will require an EP to 

enter numerators and denominators 

during attestation. Eligible hospitals and 

CAHs will have to attest they have met 

10 core objectives and 3 menu set 

objectives that require numerators and 

denominators. For objectives and 

associated measures requiring a 

numerator and denominator, we limit 

our estimates to actions taken in the 

presence of CEHRT. We do not 

anticipate a provider will maintain two 

recordkeeping systems when CEHRT is 

present. Therefore, we assume that all 

patient records that will be counted in 

the denominator will be kept using 

certified EHR technology. We expect it 

will take an individual provider or their 

designee approximately 10 minutes to 

attest to each meaningful use objective 

and associated measure that requires a 

numerator and denominator to be 

generated, as well as each CQM for 

providers attesting in their first year of 

the program. 

Additionally, providers will be 

required to report they have completed 

objectives and associated measures that 

require a ‘‘yes’’ or ‘‘no’’ response during 

attestation. For EPs, there are 3 core 

objectives and up to 3 menu set 

objectives that will require a ‘‘yes’’ or 

‘‘no’’ response during attestation. For 

eligible hospitals and CAHs, there are 5 

core objectives and that will require a 

‘‘yes’’ or ‘‘no’’ response during 

attestation and no such menu set 

objectives. We expect that it will take a 

provider or their designee 1 minute to 

attest to each objective that requires a 

‘‘yes’’ or ‘‘no’’ response. 

Providers will also be required to 

attest that they are protecting electronic 

health information. We estimate 

completion of the analysis required to 

successfully meet the associated 

measure for this objective will take 

approximately 6 hours, which is 

identical to our estimate for the Stage 1 

requirement. This burden estimate 

assumes that covered entities are 

already conducting and reviewing these 

risk analyses under current HIPAA 

regulations. Therefore, we have not 

accounted for the additional burden 

associated with the conduct or review of 

such analyses. 

Table 20 lists those objectives and 

associated measures for EPs, eligible 

hospitals and CAHs. We estimate the 

core set of objectives and associated 

measures will take an EP 8 hours and 13 

minutes to complete, and will take an 

eligible hospital or CAH 7 hours and 45 

minutes to complete. For EPs, we 

estimate the completion of 3 menu set 

objectives and associated measures will 

take between 3 minutes and 30 minutes 

to complete, depending on the 

combination of objectives they choose to 

attest to. We estimate the selection, 

preparation, and electronic submission 

of the 9 ambulatory clinical quality 

measures will take EPs 1 hour and 30 

minutes. We estimate it will take 

eligible hospitals and CAHs 30 minutes 

to attest to the 3 menu set objectives 

they choose. For eligible hospitals and 

CAHs, we estimate the selection, 

preparation, and electronic submission 

of 16 required clinical quality measures 

will take 2 hours and 40 minutes. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54127 

TABLE 20—BURDEN ESTIMATES

Eligible professionals Eligible hospitals and CAHs Stage 2 measures 

Burden estimate per 

respondent 

(EPs) 

Burden estimate per 

respondent 

(hospitals) 

CORE SET 

Use computerized provider 

order entry (CPOE) for 

medication, laboratory and 

radiology orders directly entered by any licensed 

healthcare professional who 

can enter orders into the 

medical record per state, 

local and professional 

guidelines.

Use computerized provider 

order entry (CPOE) for 

medication, laboratory and 

radiology orders directly entered by any licensed 

healthcare professional who 

can enter orders into the 

medical record per state, 

local and professional 

guidelines.

More than 60% of medication, 

30% of laboratory, and 30% 

of radiology orders created 

by the EP or authorized 

providers of the eligible 

hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) during 

the EHR reporting period 

are recorded using CPOE.

10 minutes ................. 10 minutes. 

Generate and transmit permissible prescriptions electronically (eRx)................................................. More than 50% of all permissible prescriptions, or all 

prescriptions written by the 

EP and queried for a drug 

formulary and transmitted 

electronically using CEHRT.

10 minutes.

Record the following demographics.

• Preferred language 

• Sex 

• Race 

• Ethnicity 

• Date of birth 

Record the following demographics.

• Preferred language 

• Sex 

• Race 

• Ethnicity 

• Date of birth 

• Date and preliminary cause 

of death in the event of 

mortality in the eligible hospital or CAH 

More than 80% of all unique 

patients seen by the EP or 

admitted to the eligible hospital’s or CAH’s inpatient or 

emergency department 

(POS 21 or 23) have demographics recorded as structured data.

10 minutes ................. 10 minutes. 

Record and chart changes in 

vital signs:.

• Height/length 

• Weight 

• Blood pressure (age 3 and 

over) 

• Calculate and display BMI 

• Plot and display growth 

charts for patients 0–20 

years, including BMI 

Record and chart changes in 

vital signs:.

• Height/length 

• Weight 

• Blood pressure (age 3 and 

over) 

• Calculate and display BMI 

• Plot and display growth 

charts for patients 0–20 

years, including BMI 

More than 80% of all unique 

patients seen by the EP or 

admitted to the eligible hospital’s or CAH’s inpatient or 

emergency department 

(POS 21 or 23) during the 

EHR reporting period have 

blood pressure (for patients 

age 3 and over only) and 

height/length and weight 

(for all ages) recorded as 

structured data.

10 minutes ................. 10 minutes. 

Record smoking status for patients 13 years old or older.Record smoking status for patients 13 years old or older.More than 80% of all unique 

patients 13 years old or 

older seen by the EP or admitted to the eligible hospital’s or CAH’s inpatient or 

emergency departments 

(POS 21 or 23) have smoking status recorded as 

structured data.

10 minutes ................. 10 minutes. 

Use clinical decision support 

to improve performance on 

high-priority health conditions.

Use clinical decision support 

to improve performance on 

high-priority health conditions.

1. Implement five clinical decision support interventions 

related to four or more clinical quality measures at a 

relevant point in care for 

the entire EHR reporting 

period. Absent four clinical 

quality measures related to 

an EP, eligible hospital or 

CAH’s scope of practice or 

patient population, the clinical decision support interventions must be related to 

improving healthcare efficiency.

mstockstill on DSK4VPTVN1PROD with RULES2

54128 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 20—BURDEN ESTIMATES—Continued 

Eligible professionals Eligible hospitals and CAHs Stage 2 measures 

Burden estimate per 

respondent 

(EPs) 

Burden estimate per 

respondent 

(hospitals) 

............................................ ................................................ 2. The EP, eligible hospital or 

CAH has enabled and implemented the functionality 

for drug-drug and drug-allergy interaction checks for 

the entire EHR reporting 

period.

1 minute .................... 1 minute. 

Incorporate clinical lab-test results as structured data.Incorporate clinical lab-test results as structured data.More than 55% of all clinical 

lab tests results ordered by 

the EP or by authorized 

providers of the eligible 

hospital or CAH for patients 

admitted to its inpatient or 

emergency department 

(POS 21 or 23) during the 

EHR reporting period 

whose results are either in 

a positive/negative affirmation or numerical format are 

incorporated in CEHRT as 

structured data.

10 minutes ................. 10 minutes. 

Generate lists of patients by 

specific conditions to use for 

quality improvement, reduction of disparities, research, 

or outreach.

Generate lists of patients by 

specific conditions to use 

for quality improvement, reduction of disparities, research, or outreach.

Generate at least one report 

listing patients of the EP, 

eligible hospital or CAH 

with a specific condition.

1 minute .................... 1 minute. 

Use clinically relevant information to identify patients who 

should receive reminders for 

preventive/follow-up care 

and send these patients the 

reminder, per patient preference.

................................................ More than 10% of all unique 

patients who have had two 

or more office visits with 

the EP within the 24 

months before the beginning of the EHR reporting 

period were sent a reminder, per patient preference when available.

10 minutes.

Automatically track medications from order to administration using assistive technologies in conjunction with 

an electronic medication 

administration record 

(eMAR).

More than 10% of medication 

orders created by authorized providers of the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) 

during the EHR reporting 

period for which all doses 

are tracked using eMAR.

.................................... 10 minutes. 

Provide patients the ability to 

view online, download, and 

transmit their health information within 4 business 

days of the information 

being available to the EP.

................................................ 1. More than 50% of all 

unique patients seen by the 

EP during the EHR reporting period are provided 

timely (within 4 business 

days after the information is 

available to the EP) online 

access to their health information subject to the EP’s 

discretion to withhold certain information.

2. More than 5% of all unique 

patients seen by the EP 

during the EHR reporting 

period (or their authorized 

representatives) view, 

download, or transmit to a 

third party their health information. 

10 minutes.

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54129 

TABLE 20—BURDEN ESTIMATES—Continued 

Eligible professionals Eligible hospitals and CAHs Stage 2 measures 

Burden estimate per 

respondent 

(EPs) 

Burden estimate per 

respondent 

(hospitals) 

Provide patients the ability to 

view online, download, and 

transmit information about a 

hospital admission.

1. More than 50% of all patients who are discharged 

from the inpatient or emergency department (POS 21 

or 23) of an eligible hospital 

or CAH have their information available online within 

36 hours of discharge.

2. More than 5% of all patients (or their authorized 

representatives) who are 

discharged from the inpatient or emergency department (POS 21 or 23) of an 

eligible hospital or CAH 

view, download or transmit 

to a third party their information during the reporting 

period. 

.................................... 10 minutes. 

Provide clinical summaries for 

patients for each office visit.

................................................ Clinical summaries provided 

to patients or patient-authorized representatives 

within 1 business day for 

more than 50% of office 

visits.

10 minutes.

Use CEHRT to identify patient-specific education resources and provide those 

resources to the patient.

Use CEHRT to identify patient-specific education resources and provide those 

resources to the patient.

Patient-specific education resources identified by 

CEHRT are provided to patients for more than 10% of 

all unique patients with office visits seen by the EP 

during the EHR reporting 

period.

More than 10% of all unique 

patients admitted to the eligible hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) 

are provided patient-specific education resources 

identified by CEHRT. 

10 minutes ................. 10 minutes. 

Use secure electronic messaging to communicate with 

patients on relevant health 

information.

................................................ A secure message was sent 

using the electronic messaging function of CEHRT 

by more than 5% of unique 

patients (or their authorized 

representatives) seen by 

the EP during the EHR reporting period.

10 minutes.

The EP who receives a patient from another setting of 

care or provider of care or 

believes an encounter is relevant should perform medication reconciliation.

The eligible hospital or CAH 

who receives a patient from 

another setting of care or 

provider of care or believes 

an encounter is relevant 

should perform medication 

reconciliation.

The EP, eligible hospital or 

CAH performs medication 

reconciliation for more than 

50% of transitions of care 

in which the patient is 

transitioned into the care of 

the EP or admitted to the 

eligible hospital’s or CAH’s 

inpatient or emergency department (POS 21 or 23).

10 minutes ................. 10 minutes. 

mstockstill on DSK4VPTVN1PROD with RULES2

54130 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 20—BURDEN ESTIMATES—Continued 

Eligible professionals Eligible hospitals and CAHs Stage 2 measures 

Burden estimate per 

respondent 

(EPs) 

Burden estimate per 

respondent 

(hospitals) 

The EP who transitions their 

patient to another setting of 

care or provider of care or 

refers their patient to another provider of care provides a summary care 

record for each transition of 

care or referral.

The eligible hospital or CAH 

who transitions their patient 

to another setting of care or 

provider of care or refers 

their patient to another provider of care provides a 

summary care record for 

each transition of care or 

referral.

1. The EP, eligible hospital, or 

CAH that transitions or refers their patient to another 

setting of care or provider 

of care provides a summary 

of care record for more 

than 50% of transitions of 

care and referrals.

2. The EP, eligible hospital or 

CAH that transitions or refers their patient to another 

setting of care or provider 

of care provides a summary 

of care record for more 

than 10% of such transitions and referrals either (a) 

electronically transmitted 

using CEHRT to a recipient 

or (b) where the recipient 

receives the summary of 

care record via exchange 

facilitated by an organization that is a NwHIN Exchange participant or in a 

manner that is consistent 

with the governance mechanism ONC establishes for 

the nationwide health information network. 

3. An EP, eligible hospital or 

CAH must satisfy one of 

the two following criteria: 

(A) conducts one or more 

successful electronic exchanges of a summary of 

care document, as part of 

which is counted in ‘‘measure 2’’ (for EPs the measure at § 495.6(j)(14)(ii)(B) 

and for eligible hospitals 

and CAHs the measure at 

§ 495.6(l)(11)(ii)(B)) with a 

recipient who has EHR 

technology that was developed designed by a different EHR technology developer than the sender’s 

EHR technology certified to 

45 CFR 170.314(b)(2). 

10 minutes ................. 10 minutes. 

Capability to submit electronic 

data to immunization registries or immunization information systems except 

where prohibited, and in accordance with applicable 

law and practice.

Capability to submit electronic 

data to immunization registries or immunization information systems except 

where prohibited, and in accordance with applicable 

law and practice.

Successful ongoing submission of electronic immunization data from CEHRT to 

an immunization registry or 

immunization information 

system for the entire EHR 

reporting period.

1 minute .................... 1 minute. 

Capability to submit electronic 

reportable laboratory results 

to public health agencies, 

except where prohibited, 

and in accordance with applicable law and practice.

Successful ongoing submission of electronic reportable 

laboratory results from 

CEHRT to public health 

agencies for the entire EHR 

reporting period.

.................................... 1 minute. 

Capability to submit electronic 

syndromic surveillance data 

to public health agencies, 

except where prohibited, 

and in accordance with applicable law and practice.

Successful ongoing submission of electronic syndromic 

surveillance data from 

CEHRT to a public health 

agency for the entire EHR 

reporting period.

.................................... 1 minute. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54131 

TABLE 20—BURDEN ESTIMATES—Continued 

Eligible professionals Eligible hospitals and CAHs Stage 2 measures 

Burden estimate per 

respondent 

(EPs) 

Burden estimate per 

respondent 

(hospitals) 

Protect electronic health information created or maintained by the CEHRT 

through the implementation 

of appropriate technical capabilities.

Protect electronic health information created or maintained by the CEHRT 

through the implementation 

of appropriate technical capabilities.

Conduct or review a security 

risk analysis in accordance 

with the requirements under 

45 CFR 164.308(a)(1), including addressing the 

encryption/security of data 

stored in CEHRT in accordance with requirements 

under 45 CFR 164.312 (a)

(2)(iv) and 45 CFR 164.306

(d)(3), and implement security updates as necessary 

and correct identified security deficiencies as part of 

the provider’s risk management process.

6 hours ...................... 6 hours. 

Core Set Burden 8 hours 13 minutes ... 7 hours 45 minutes. 

MENU SET 

Record whether a patient 65 

years old or older has an 

advance directive.

More than 50% of all unique 

patients 65 years old or 

older admitted to the eligible hospital’s or CAH’s inpatient department (POS 

21) during the EHR reporting period have an indication of an advance directive 

status recorded as structured data.

.................................... 10 minutes. 

Imaging results consisting of 

the image itself and any explanation or other accompanying information are accessible through CEHRT.

Imaging results consisting of 

the image itself and any explanation or other accompanying information are accessible through CEHRT.

More than 10% of all tests 

whose result is one or 

moreimages ordered by the 

EP or by an authorized provider of the eligible hospital 

or CAH for patients admitted to its inpatient or emergency department (POS 21 

and 23) during the EHR reporting period are accessible through CEHRT.

10 minutes ................. 10 minutes. 

Record patient family health 

history as structured data.

Record patient family health 

history as structured data.

More than 20% of all unique 

patients seen by the EP or 

admitted to the eligible hospital or CAH’s inpatient or 

emergency department 

(POS 21 or 23) during the 

EHR reporting period have 

a structured data entry for 

one or more first-degree 

relatives.

10 minutes ................. 10 minutes. 

Generate and transmit permissible discharge prescriptions electronically (eRx).More than 10% of hospital 

discharge medication orders for permissible prescriptions (for new, 

changed, and refilled prescriptions) are queried for a 

drug formulary and transmitted electronically using 

CEHRT.

.................................... 10 minutes 

mstockstill on DSK4VPTVN1PROD with RULES2

54132 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 20—BURDEN ESTIMATES—Continued 

Eligible professionals Eligible hospitals and CAHs Stage 2 measures 

Burden estimate per 

respondent 

(EPs) 

Burden estimate per 

respondent 

(hospitals) 

Record electronic notes in patient records.Record electronic notes in patient records.Enter at least one electronic 

progress note created, edited, and signed by an eligible professional for more 

than 30 percent of unique 

patients with at least one 

office visit during the EHR 

reporting period.

Enter at least one electronic 

progress note created, edited and signed by an authorized provider of the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) 

for more than 30 percent of 

unique patients admitted to 

the eligible hospital or 

CAH’s inpatient or emergency department during 

the EHR reporting period. 

Electronic progress notes 

must be text-searchable. 

Nonsearchable, notes do 

not qualify, but this does 

not mean that all of the 

content has to be character 

text. Drawings and other 

content can be included 

with searchable notes 

under this measure. 

10 minutes ................. 10 minutes. 

Provide structured electronic 

lab results to ambulatory 

providers.

Hospital labs send structured 

electronic clinical lab results 

to the ordering provider for 

more than 20% of electronic lab orders received.

.................................... 10 minutes 

Capability to submit electronic 

syndromic surveillance data 

to public health agencies, 

except where prohibited, 

and in accordance with applicable law and practice.

................................................ Successful ongoing submission of electronic syndromic 

surveillance data from 

CEHRT to a public health 

agency for the entire EHR 

reporting period.

1 minute.

Capability to identify and report cancer cases to a public health central cancer registry, except where prohibited, and in accordance with 

applicable law and practice.

................................................ Successful ongoing submission of cancer case information from CEHRT to a 

public health central cancer 

registry for the entire EHR 

reporting period.

1 minute.

Capability to identify and report specific cases to a specialized registry (other than 

a cancer registry), except 

where prohibited, and in accordance with applicable 

law and practice.

................................................ Successful ongoing submission of specific case information from CEHRT to a 

specialized registry for the 

entire EHR reporting period.

1 minute.

Menu Set Least Burdensome Criteria 3 minutes.

Menu Set Most Burdensome Criteria 30 minutes ................. 30 minutes. 

Time to Attest and Report Clinical Quality Measures 1 hour 30 minutes ..... 2 hours 40 minutes. 

Total—Core Set (including CQMs) + Least Burdensome Menu Set Criteria 9 hours 46 minutes.

Total—Core Set (including CQMs) + Most Burdensome Menu Set Criteria 10 hours 13 minutes. 10 hours 55 minutes. 

First, we will discuss the burden 

associated with the EP attestation to 

meeting the core meaningful use 

objectives and associated measures. We 

estimate that it will take no longer than 

8 hours and 13 minutes to attest that 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54133 

during the EHR reporting period, they 

used the CEHRT, specify the EHR 

technology used, and satisfy each of the 

applicable core objectives and 

associated measures. We estimate it will 

take an EP 30 minutes if they choose to 

submit the most burdensome objectives 

and associated measures from the menu 

set. If an EP chooses to attest to the least 

burdensome menu set objectives and 

associated measures, we estimate this 

will take approximately 3 minutes. We 

also estimate that it will take an EP an 

additional 1 hour and 30 minutes to 

select, prepare, and electronically 

submit the ambulatory clinical quality 

measures. The total burden hours for an 

EP to attest to the most burdensome 

criteria previously specified is 10 hours 

and 13 minutes. The total burden hours 

for an EP to attest to the least 

burdensome criteria previously 

specified is 9 hours and 46 minutes. We 

estimate that there could be 

approximately 537,600 nonhospitalbased Medicare and Medicaid EPs in 

2014. We anticipate approximately 37 

percent (198,912) of these EPs may 

attest to the information previously 

specified (after registration and 

completion of Stage 1) in CY 2014 to 

receive an incentive payment. We 

estimate the burden for the 

approximately 13,000 MA EPs in the 

MAO burden section. We estimate the 

total burden associated with these 

requirements for an EP is 10 hours and 

13 minutes (8 hours 13 minutes + 30 

minutes + 1 hour 30 minutes). The total 

estimated annual cost burden for all EPs 

to attest to EHR technology, meaningful 

use core set and most burdensome menu 

set criteria, and electronically submit 

the ambulatory clinical quality 

measures is $182,877,942 (198,912 EPs 

× 10 hours 13 minutes × $89.96 (mean 

hourly rate for physicians based on May 

2010 Bureau of Labor Statistics (BLS) 

data)). We estimate the total burden 

associated with these requirements for 

an EP is 9 hours and 46 minutes (8 

hours 13 minutes + 3 minutes + 1 hour 

30 minutes). The total estimated cost 

burden for all EPs to attest to EHR 

technology, meaningful use core set and 

least burdensome menu set criteria, and 

electronically submit the ambulatory 

clinical quality measures is 

$174,825,587 (198,912 EPs × 9 hours 46 

minutes × $89.96 (mean hourly rate for 

physicians based on May 2010 BLS 

data)). 

Similarly, eligible hospitals and CAHs 

will attest that they have met the core 

meaningful use objectives and 

associated measures, and will 

electronically submit the clinical quality 

measures. We estimate that it will take 

no longer than 7 hours and 45 minutes 

to attest that during the EHR reporting 

period, they used the CEHRT, specify 

the EHR technology used, and satisfied 

each of the applicable core objectives 

and associated measures. We estimate it 

will take an eligible hospital or CAH 30 

minutes to choose and submit the 

objectives and associated measures from 

the menu set. We also estimate that it 

will take an eligible hospital or CAH an 

additional 2 hours and 40 minutes to 

select, prepare, and electronically 

submit the clinical quality measures. 

Therefore, the total burden hours for an 

eligible hospital or CAH to attest to the 

aforementioned criteria is 10 hours, 55 

minutes. We estimate that there are 

about 4,993 eligible hospitals and CAHs 

(3,573 acute care hospitals, 1,325 CAHs, 

84 children’s hospitals, and 11 cancer 

hospitals) that may attest to the 

aforementioned criteria (after 

registration and completion of Stage 1) 

in FY 2014 to receive an incentive 

payment. We estimate the burden for 

the 30 MA-affiliated hospitals in section 

III.B. of this final rule. We estimate the 

total burden associated with these 

requirements for an eligible hospital or 

CAH is 10 hours and 55 minutes (7 

hours 45 minutes + 30 minutes + 2 

hours 40 minutes). The total estimated 

annual cost burden for all eligible 

hospitals and CAHs to attest to EHR 

technology, meaningful use core set and 

menu set criteria, and electronically 

submit the clinical quality measures is 

$2,069,061 (4,993 eligible hospitals and 

CAHs × $62.23 (11 hours 4 minutes × 

$62.23 (mean hourly rate for lawyers 

based on May 2010 BLS) data)). 

B. ICRs Regarding Qualifying MA 

Organizations (§ 495.210) 

We estimate that the burden will be 

significantly less for qualifying MA 

organizations attesting to the 

meaningful use of their MA EPs in Stage 

2, because—(1) qualifying MA 

organizations do not have to report the 

ambulatory clinical quality measures for 

their qualifying MA EPs; and (2) 

qualifying MA EPs use the EHR 

technology in place at a given location 

or system, so if CEHRT is in place and 

the qualifying MA organization requires 

its qualifying MA EPs to use the 

technology, qualifying MA 

organizations will be able to determine 

at a faster rate than individual FFS EPs, 

that its qualifying MA EPs meaningfully 

used CEHRT. In other words, qualifying 

MA organizations can make the 

determination en masse if the CEHRT is 

required to be used at its facilities, 

whereas under FFS, each EP likely must 

make the determination on an 

individual basis. We estimate that, on 

average, it will take an individual 45 

minutes to collect information necessary 

to determine if a given qualifying MA 

EP has met the meaningful use 

objectives and measures, and 15 

minutes for an individual to make the 

attestation for each MA EP. 

Furthermore, the individuals 

performing the assessment and attesting 

will not likely be eligible professionals, 

but non-clinical staff. We believe that 

the individual gathering the information 

could be equivalent to a GS 9, step 1, 

with an hourly rate of approximately 

$25.00/hour, and the person attesting 

(and who may bind the qualifying MA 

organization based on the attestation) 

could be equivalent to a GS 15, step 1, 

or approximately $59.00/hour. 

Therefore, for the approximately 13,000 

potentially qualifying MA EPs, we 

believe it will cost the participating 

qualifying MA organizations 

approximately $435,500 annually to 

make the attestations ([9,750 hours × 

$25.00] + [3,250 hours × $59.00]). 

Furthermore, MA-affiliated eligible 

hospitals will be able to complete the 

attestations slightly faster than eligible 

hospitals because MA-affiliated eligible 

hospitals do not have to report the 

hospital clinical quality measures. 

While it is estimated that it will take an 

eligible hospital or CAH approximately 

between 16 hours, 24 minutes and 16 

hours, 33 minutes to attest to the 

applicable meaningful use objectives 

and associated measures, 8 of those 

hours are attributed to reporting clinical 

quality measures, which MA 

organizations do not have to report. 

Therefore, we estimate that it will take 

between 8 hours, 24 minutes and 8 

hours, 33 minutes (which on average is 

8 hours 29 minutes) for an MA 

organization’s MA-affiliated eligible 

hospitals to make the attestations. We 

believe that the individual gathering the 

information could be equivalent to a GS 

9, step 1, with an hourly rate of 

approximately $25.00/hour, and the 

person attesting (and who may bind the 

qualifying MA organization based on 

the attestation) could be equivalent to a 

GS 15, step 1, or approximately $59.00/ 

hour. We believe that the person 

gathering the information could 

dedicate 7 of the estimated hours to 

gathering the information, and the 

individual certifying could take 1 hour 

and 29 minutes of the estimated time. 

Therefore, for the approximately 30 

potentially qualifying MA-affiliated 

eligible hospitals, we believe it will cost 

the participating qualifying MA 

organizations in the aggregate 

approximately $7,870 annually to 

mstockstill on DSK4VPTVN1PROD with RULES2

54134 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

successfully attest ([210 hrs × $25.00] + 

[44 hrs × $59.00]). 

We did not receive any comments and 

we are finalizing these estimates as 

proposed. 

C. ICRs Regarding State Medicaid 

Agency and Medicaid EP and Hospital 

Activities (§ 495.332 Through § 495.344) 

The burden associated with this 

section is the time and effort associated 

with completing the single provider 

election repository and each state’s 

process for the administration of the 

Medicaid incentive payments, including 

tracking of attestations and oversight; 

the submission of the state Medicaid 

HIT Plan and the additional planning 

and implementation documents; 

enrollment or reenrollment of providers, 

and collection and submission of the 

data for providers to demonstrate that 

they have adopted, implemented, or 

upgraded CEHRT or that they are 

meaningful users of such technology. 

We believe the burden associated with 

these requirements has already been 

accounted for in our discussion of the 

burden for § 495.316 in the Stage 1 final 

rule. However, we proposed to revise 42 

CFR 495 regarding the frequency of HIT 

IAPD updates. Rather than requiring 

each state to submit an annual HIT 

IAPD within 60 days from the HIT IAPD 

approved anniversary date, we proposed 

to require that a state’s annual IAPD or 

IAPD Update (IAPD–U) be submitted at 

a minimum of 12 months from the date 

of the last CMS approval. We are 

finalizing our proposed revision to 42 

CFR 495; therefore, annual IAPD 

updates are only required if a state has 

not submitted an IAPD–U in the past 12 

months, which will create less of a 

burden on the states. We expect that it 

will take a state 70 hours to update an 

annual IAPD. We believe that the 

requirement for states to agree to have 

CMS conduct audits and appeals for 

hospitals for meaningful use will reduce 

state burden, as they will not conduct 

their own audits. Also, the alternatives 

for calculating patient volume will 

alleviate state burden as patient volume 

will be more easily calculated. 

We did not receive any comments and 

we are finalizing these estimates as 

proposed. 

TABLE 21—ESTIMATED ANNUAL REPORTING AND RECORDKEEPING REQUIREMENTS

Reg section OMB Control 

No. 

Number of 

respondents 

Number of 

responses 

Burden per 

response 

(hours) 

Total annual 

burden 

(hours) 

Hourly labor 

cost of 

reporting 

($) 

Total cost 

($) 

§ 495.6—EHR 

Technology Used, 

Core Set Objectives/Measures 

(EPs) ................... ???-New 198,912 198,912 8.22 1,635,057 89.96 147,089,695.33 

§ 495.6—Menu Set 

Objectives/Measures (EPs) HIGH ???-New 198,912 198,912 0.50 99,456 89.96 8,947,061.76 

§ 495.6—Menu Set 

Objectives/Measures (EPs) LOW ???-New 198,912 198,912 0.05 9,946 89.96 894,706.18 

§ 495.6—Menu Set 

Objectives/Measures (EPs) AVERAGE ............... ???-New 198,912 198,912 0.28 54,701 89.96 4,920,883.97 

§ 495.8—CQMs for 

EPs ..................... ???-New 198,912 198,912 1.50 298,368 89.96 26,841,185.28 

§ 495.6—EHR 

Technology Used, 

Core Set Objectives/Measures 

(hospitals/CAHs) ???-New 2,696 2,696 7.75 20,894 62.23 1,300,233.62 

§ 495.6—Menu Set 

Objectives/Measures (hospitals/ 

CAHs) ................. ???-New 2,696 2,696 0.50 1,348 89.96 121,266.08 

§ 495.8—CQMs for 

hospitals/CAHs ... ???-New 2,696 2,696 2.67 7,198 89.96 647,560.87 

§ 495.210—Gather 

information for attestation (MA 

EPs) .................... ???-New 13,000 13,000 0.75 9,750 25.00 243,750.00 

§ 495.210—Attesting on behalf of 

MA EPs .............. ???-New 13,000 13,000 0.25 3,250 59.00 191,750.00 

§ 495.210—Total 

cost of attestation 

for Stage 2 (MA 

EPs) .................... ???-New 13,000 13,000 1.00 13,000 n/a 435,500.00 

§ 495.210—Gather 

information for attestation (MA-affiliated hospitals) ???-New 30 30 7.00 210 25.00 5,250.00 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54135 

TABLE 21—ESTIMATED ANNUAL REPORTING AND RECORDKEEPING REQUIREMENTS—Continued 

Reg section OMB Control 

No. 

Number of 

respondents 

Number of 

responses 

Burden per 

response 

(hours) 

Total annual 

burden 

(hours) 

Hourly labor 

cost of 

reporting 

($) 

Total cost 

($) 

§ 495.210—Attesting on behalf of 

MA-affiliated hospitals ................... ???-New 30 30 1.48 44 59.00 2,619.60 

§ 495.210—Total 

cost of attestation 

for Stage 2 (MAaffiliated hospitals) .................. ???-New 30 30 8.48 254 n/a 7,869.60 

§ 495.342–1. Frequency of Health 

Information Technology (HIT) Implementation Advanced Planning 

Document (IAPD) 

Updates .............. ???-New 56 56 70.00 3,920 56.24 220,460.80 

Burden Total 

for 2014 ....... ........................ ........................ ........................ ........................ 2,034,740.16 ........................ 181,584,656 

Note: All nonwhole numbers in this table are rounded to 2 decimal places. 

If you would like to comment on 

these information collection and 

recordkeeping requirements, submit 

your comments to the Office of 

Information and Regulatory Affairs, 

Office of Management and Budget, 

Attention: CMS Desk Officer, [CMS– 

0044–F], Fax: (202) 395–6974; or Email: 

OIRA_submission@omb.eop.gov. 

V. Regulatory Impact Analysis 

A. Statement of Need 

This final rule will implement the 

provisions of the ARRA that provide 

incentive payments to EPs, eligible 

hospitals, and CAHs participating in 

Medicare and Medicaid programs that 

adopt and meaningfully use CEHRT. 

The final rule specifies applicable 

criteria for earning incentives and 

avoiding payment adjustments. 

B. Overall Impact 

We have examined the impacts of this 

rule as required by Executive Order 

12866 on Regulatory Planning and 

Review (September 30, 1993), Executive 

Order 13563 on Improving Regulation 

and Regulatory Review (January 18, 

2011), the Regulatory Flexibility Act 

(RFA) (September 19, 1980, Pub. L. 96– 

354), section 1102(b) of the Social 

Security Act, section 202 of the 

Unfunded Mandates Reform Act of 1995 

(March 22, 1995; Pub. L. 104–4), 

Executive Order 13132 on Federalism 

(August 4, 1999) and the Congressional 

Review Act (5 U.S.C. 804(2)). 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). A regulatory impact analysis 

(RIA) must be prepared for major rules 

with economically significant effects 

($100 million or more in any 1 year). 

This final rule is anticipated to have an 

annual effect on the economy of $100 

million or more, making it an 

economically significant rule under the 

Executive Order and a major rule under 

the Congressional Review Act. 

Accordingly, we have prepared a 

Regulatory Impact Analysis that to the 

best of our ability presents the costs and 

benefits of the final rule. 

As noted in section I. of this final 

rule, this final rule is one of two 

coordinated rules related to the 

adoption and meaningful use of CEHRT. 

The other is ONC’s final rule, titled 

‘‘Health Information Technology: 

Standards, Implementation 

Specifications, and Certification Criteria 

for Electronic Health Record 

Technology, 2014 Edition; Revisions to 

the Permanent Certification Program for 

Health Information Technology’’ 

published elsewhere in this Federal 

Register. This analysis focuses on the 

impact associated with Stage 1 

meaningful use participation in 2014, 

Stage 2 requirements for meaningful 

use, the changes in quality measures 

that will take effect beginning in 2014, 

and other changes in the Medicare and 

Medicaid EHR Incentive Programs. 

A number of factors will affect the 

adoption of EHR systems and 

demonstration of meaningful use. Many 

of these factors are addressed in this 

analysis and in the provisions of the 

final rule titled ‘‘Health Information 

Technology: Standards, Implementation 

Specifications, and Certification Criteria 

for Electronic Health Record 

Technology, 2014 Edition; Revisions to 

the Permanent Certification Program for 

Health Information Technology’’ 

published elsewhere in this Federal 

Register. Readers should understand 

that these forecasts are also subject to 

substantial uncertainty since 

demonstration of meaningful use will 

depend not only on the standards and 

requirements for FYs 2014 and 2015 for 

eligible hospitals and CYs 2014 and 

2015 for EPs, but on future rulemakings 

issued by the HHS. 

The Act provides Medicare and 

Medicaid incentive payments for the 

meaningful use of CEHRT. Additionally, 

the Medicaid program also provides 

incentives for the adoption, 

implementation, and upgrade of 

CEHRT. Payment adjustments are 

incorporated into the Medicare program 

for providers unable to demonstrate 

meaningful use. The absolute and 

relative strength of these is unclear. For 

example, a provider with relatively 

small Medicare billings will be less 

disadvantaged by payment adjustments 

than one with relatively large Medicare 

billings. Another uncertainty arises 

because there are likely to be 

‘‘bandwagon’’ effects as the number of 

providers using EHRs rises, thereby 

inducing more participation in the 

mstockstill on DSK4VPTVN1PROD with RULES2

54136 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

incentives program, as well as greater 

adoption by entities (for example, 

clinical laboratories) that are not eligible 

for incentives or subject to payment 

adjustments, but do business with EHR 

adopters. It is impossible to predict 

exactly if and when such effects may 

take hold. 

One legislative uncertainty arises 

because under current law, physicians 

are scheduled for payment reductions 

under the sustainable growth rate (SGR) 

formula for determining Medicare 

payments. The current override of SGR 

payment reductions prevents any 

further reductions of Medicare 

physician payments throughout the rest 

of 2012. Any payment reductions 

implemented in CY 2013 and 

subsequent calendar years could cause 

major changes in physician behavior, 

enrollee care, and other Medicare 

provider payments, but the specific 

nature of these changes is exceptionally 

uncertain. Under a current law scenario, 

the EHR incentives or payment 

adjustments will exert only a minor 

influence on physician behavior relative 

to any large payment reductions. 

However, the Congress has legislatively 

avoided physician payment reductions 

for each year since 2002. 

All of these factors taken together 

make it difficult to predict with 

precision the timing or rates of adoption 

and ultimately meaningful use. Further, 

new data regarding rates of adoption or 

costs of implementation is just starting 

to emerge. Because of this continued 

uncertainty, these estimates for 

adoption rates should be used with 

caution. Our estimate of meaningful use 

demonstration assumes that by 2019 

nearly 100 percent of hospitals and 

nearly 70 percent of EPs will be 

meaningful users. This estimate is based 

on the substantial economic incentives 

created by the combined direct and 

indirect factors affecting providers. 

Data from the EHR Incentive Program 

to date has shown that about 12 percent 

of EPs and 8 percent of hospitals 

received incentive payments in 2011, 

the first year. This may be because 

providers have taken a ‘‘wait and see 

approach’’ in the first year of 

implementation or that they have had 

problems receiving certified systems. 

Two thousand eleven was the first year 

of the program and saw initially slow, 

but rapidly accelerating, growth in 

qualification for and payment of 

meaningful use incentives. Given that 

this is very early data, and given the 

differences between Stage 1 and Stage 2 

requirements, this data only indicates 

preliminary penetration rates. 

Overall, we expect spending under 

the EHR incentive program for transfer 

payments to Medicare and Medicaid 

providers between 2014 and 2019 to be 

$15.4 billion (these estimates include 

payment adjustments for Medicare 

providers who do not achieve 

meaningful use in 2015 and subsequent 

years in the amount of $2.1 billion). We 

have also estimated ‘‘per entity’’ costs 

for EPs, eligible hospitals, and CAHs for 

implementation/maintenance and 

reporting requirement costs, not all 

costs. We believe also that adopting 

entities will achieve dollar savings at 

least equal to their total costs, and that 

there will be additional benefits to 

society. We believe that implementation 

costs are significant for each 

participating entity because providers 

must purchase CEHRT to qualify as 

meaningful users of EHRs. However, we 

believe that providers who have already 

purchased CEHRT and participated in 

Stage 1 of meaningful use will 

experience significantly lower costs for 

participation in the program. We 

continue to believe that the short-term 

costs to demonstrate meaningful use of 

CEHRT are outweighed by the long-term 

benefits, including practice efficiencies 

and improvements in medical 

outcomes. Although both cost and 

benefit estimates are highly uncertain, 

the RIA that we have prepared to the 

best of our ability presents the costs and 

benefits of this final rule. 

Previously, the Stage 2 proposed rule 

and the Stage 1 final rule impact 

analyses showed two plausible 

scenarios for program costs. In this RIA, 

we are showing a scenario based on the 

FY 2013 Mid-Session Review of the 

President’s budget. The estimates are 

based on the limited actual historical 

data that is now available for the EHR 

Incentive Programs. The new 

projections differ somewhat from the 

two scenarios presented previously. The 

major reasons for the differences are 

different assumed penetration rates 

based on more recent data and analysis, 

and revised assumptions as to the 

timing of payments in relation to when 

meaningful use is achieved based on the 

actual experience of the programs to 

date. When compared with the two 

illustrations from the Stage 2 proposed 

rule and Stage 1 final rule, the 

penetration rates for the current 

estimates are generally closer to those in 

the high cost scenario. In general, the 

actual program experience, which is 

included in the new estimates, showed 

somewhat lower payments early in the 

first year, and somewhat higher 

payments towards the end of the first 

year than assumed in the two 

previously-used scenarios. The 

accounting statement numbers under 

the 7-percent discount for the two 

scenarios from the previous estimates 

were $706 million and $2,346 million. 

The current accounting statement 

number under the 7-percent discount is 

$2,558 million. The current projections, 

while based on more up-to-date 

information, are still very uncertain and 

actual future outcomes are likely to 

differ somewhat from these projections. 

Comment: A commenter suggested 

that the impact analysis should only 

address Stage 2 of the EHR Incentive 

Programs. 

Response: Although we considered 

the idea of only addressing Stage 2 in 

this impact analysis, we do not believe 

that such an analysis would provide a 

comprehensive impact of this final rule. 

This final rule establishes not only Stage 

2 criteria but also changes to Stage 1 

criteria and both payment adjustments 

and hardship exceptions that could 

affect providers at all stages of 

meaningful use. In addition, providers 

in all payment years will be at differing 

stages of meaningful use, and any 

impact analysis that focused on a single 

stage would not accurately capture the 

costs and benefits that accrue from all 

providers who are participating in the 

EHR Incentive Programs during a given 

payment year. Therefore, we include all 

providers in this impact analysis. 

C. Anticipated Effects 

The objective of the remainder of this 

RIA is to summarize the costs and 

benefits of the HITECH Act incentive 

program for the Medicare FFS, 

Medicaid, and MA programs. We also 

provide assumptions and a narrative 

addressing the potential costs to the 

industry for implementation of this 

technology. 

1. Overall Effects 

a. Regulatory Flexibility Analysis and 

Small Entities 

The Regulatory Flexibility Act (RFA) 

requires agencies to prepare a Final 

Regulatory Flexibility Analysis to 

describe and analyze the impact of the 

final rule on small entities unless the 

Secretary can certify that the regulation 

will not have a significant impact on a 

substantial number of small entities. In 

the healthcare sector, Small Business 

Administration (SBA) size standards 

define a small entity as one with 

between $7 million and $34 million in 

annual revenues. For the purposes of 

the RFA, essentially all non-profit 

organizations are considered small 

entities, regardless of size. Individuals 

and states are not included in the 

definition of a small entity. Since the 

vast majority of Medicare providers 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54137 

(well over 90 percent) are small entities 

within the RFA’s definitions, it is the 

normal practice of HHS simply to 

assume that all affected providers are 

‘‘small’’ under the RFA. In this case, 

most EPs, eligible hospitals, and CAHs 

are either nonprofit or meet the SBA’s 

size standard for small business. We 

also believe that the effects of the 

incentives program on many and 

probably most of these affected entities 

will be economically significant. 

Accordingly, this RIA section, in 

conjunction with the remainder of the 

preamble, constitutes the required 

Regulatory Flexibility Analysis. We 

believe that the adoption and 

meaningful use of EHRs will have an 

impact on virtually every EP and 

eligible hospital, as well as CAHs and 

some EPs and hospitals affiliated with 

MA organizations. While the program is 

voluntary, in the first 5 years it carries 

substantial positive incentives that will 

make it attractive to virtually all eligible 

entities. Furthermore, entities that do 

not demonstrate meaningful use of EHR 

technology for an applicable reporting 

period will be subject to significant 

Medicare payment reductions beginning 

with 2015. The anticipation of these 

Medicare payment adjustments are 

expected to motivate EPs, eligible 

hospitals, and CAHs to adopt and 

meaningfully use certified EHR 

technology. 

For some EPs, CAHs and eligible 

hospitals the EHR technology they 

currently have could be upgraded to 

meet the criteria for certified EHR 

technology as defined for this program. 

These costs may be minimal, involving 

no more than a software upgrade. 

‘‘Home-grown’’ EHR systems that might 

exist may also require an upgrade to 

meet the certification requirements. We 

believe many currently noncertified 

EHR systems will require significant 

changes to achieve certification and that 

EPs, CAHs, and eligible hospitals will 

have to make process changes to achieve 

meaningful use. 

The most recent data available 

suggests that more providers have 

adopted EHR technology since the 

publication of the Stage 1 final rule. A 

2011 survey conducted by the ONC and 

the AHA found that the percentage of 

U.S. hospitals which had adopted EHRs 

doubled from 16 to 35 percent between 

2009 and 2011. In November 2011, a 

CDC survey found the percentage of 

physicians who adopted basic EHRs in 

their practice had doubled from 17 to 34 

percent between 2008 and 2011, with 

the percent of primary care doctors 

using this technology nearly doubling 

from 20 to 39 percent. While these 

numbers are encouraging, they are still 

low relative to the overall population of 

providers. The majority of EPs still need 

to purchase certified EHR technology, 

implement this new technology, and 

train their staff on its use. The costs for 

implementation and complying with the 

criteria of meaningful use could lead to 

higher operational expenses. However, 

we believe that the combination of 

payment incentives and long-term 

overall gains in efficiency will 

compensate for the initial expenditures. 

(1) Number of Small Entities 

In total, we estimate that there are 

approximately 624,000 healthcare 

organizations (EPs, practices, eligible 

hospitals or CAHs) that will be affected 

by the incentive program. These include 

hospitals and physician practices as 

well as doctors of medicine or 

osteopathy, dental surgery or dental 

medicine, podiatric medicine, 

optometry or a chiropractor. 

Additionally, as many as 47,000 

nonphysician practitioners (such as 

certified nurse-midwives, etc) will be 

eligible to receive the Medicaid 

incentive payments. 

Of the 624,000 healthcare 

organizations we estimate will be 

affected by the incentive program, we 

estimate that 94.71 percent will be EPs, 

0.8 percent will be hospitals, and 4.47 

percent will be MA organization 

physicians or hospitals. We further 

estimate that EPs will spend 

approximately $54,000 to purchase and 

implement a certified EHR and $10,000 

annually for ongoing maintenance 

according to the Congressional Budget 

Office (CBO). In the paper, Evidence on 

the Costs and Benefits of Health 

Information Technology, May 2008, in 

attempting to estimate the total cost of 

implementing health IT systems in 

office-based medical practices, 

recognized the complicating factors of 

EHR types, available features, and 

differences in characteristics of the 

practices that are adopting them. The 

CBO estimated a cost range of $25,000 

to $45,000 per physician. For all eligible 

hospitals, the range is from $1 million 

to $100 million. Though reports vary 

widely, we anticipate that the average 

will be $5 million to achieve meaningful 

use. We estimate $1 million for 

maintenance, upgrades, and training 

each year. 

(2) Conclusion 

As discussed later in this analysis, we 

believe that there are many positive 

effects of adopting EHR on health care 

providers, quite apart from the incentive 

payments to be provided under this 

rule. While economically significant, we 

do not believe that the net effect on 

individual providers will be negative 

over time except in very rare cases. 

Accordingly, we believe that the object 

of the RFA to minimize burden on small 

entities is met by this rule. 

b. Small Rural Hospitals 

Section 1102(b) of the Act requires us 

to prepare a RIA if a rule will have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 604 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a metropolitan statistical area and has 

fewer than 100 beds. This final rule will 

affect the operations of a substantial 

number of small rural hospitals because 

they may be subject to adjusted 

Medicare payments in 2015 if they fail 

to adopt certified EHR technology by the 

applicable reporting period. As stated 

previously, we have determined that 

this final rule will create a significant 

impact on a substantial number of small 

entities, and have prepared a Regulatory 

Flexibility Analysis as required by the 

RFA and, for small rural hospitals, 

section 1102(b) of the Act. Furthermore, 

any impacts that will arise from the 

implementation of certified EHR 

technology in a rural eligible hospital 

will be positive, with respect to the 

streamlining of care and the ease of 

sharing information with other EPs to 

avoid delays, duplication, or errors. 

However, we have statutory authority to 

make case-by-case exceptions for 

significant hardship, and proposed 

certain case-by-case applications that 

may be made when there are barriers to 

internet connectivity that will impact 

health information exchange. 

c. Unfunded Mandates Reform Act 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates will require 

spending in any 1 year $100 million in 

1995 dollars, updated annually for 

inflation. In 2012, that threshold is 

approximately $139 million. UMRA 

does not address the total cost of a rule. 

Rather, it focuses on certain categories 

of cost, mainly those ‘‘Federal mandate’’ 

costs resulting from—(1) imposing 

enforceable duties on State, local, or 

tribal governments, or on the private 

sector; or (2) increasing the stringency of 

conditions in, or decreasing the funding 

of, State, local, or tribal governments 

under entitlement programs. 

This final rule imposes no substantial 

mandates on States. This program is 

voluntary for States and States offer the 

mstockstill on DSK4VPTVN1PROD with RULES2

54138 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

incentives at their option. The State role 

in the incentive program is essentially 

to administer the Medicaid incentive 

program. While this entails certain 

procedural responsibilities, these do not 

involve substantial State expense. In 

general, each State Medicaid Agency 

that participates in the incentive 

program will be required to invest in 

systems and technology to comply. 

States will have to identify and educate 

providers, evaluate their attestations 

and pay the incentive. However, the 

Federal government will fund 90 

percent of the State’s related 

administrative costs, providing controls 

on the total State outlay. 

The investments needed to meet the 

meaningful use standards and obtain 

incentive funding are voluntary, and 

hence not ‘‘mandates’’ within the 

meaning of the statute. However, the 

potential reductions in Medicare 

reimbursement beginning with FY 2015 

will have a negative impact on 

providers that fail to meaningfully use 

certified EHR technology for the 

applicable reporting period. We note 

that we have no discretion as to the 

amount of those potential payment 

reductions. Private sector EPs that 

voluntarily choose not to participate in 

the program may anticipate potential 

costs in the aggregate that may exceed 

$139 million; however, because EPs 

may choose for various reasons not to 

participate in the program, we do not 

have firm data for the percentage of 

participation within the private sector. 

This RIA, taken together with the 

remainder of the preamble, constitutes 

the analysis required by UMRA. 

d. Federalism 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a final 

rule that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This final rule will not have a 

substantial direct effect on State or local 

governments, preempt State law, or 

otherwise have a Federalism 

implication. Importantly, State 

Medicaid agencies are receiving 100 

percent match from the Federal 

government for incentives paid and a 90 

percent match for expenses associated 

with administering the program. As 

previously stated, we believe that State 

administrative costs are minimal. We 

note that this final rule does add a new 

business requirement for States, because 

of the existing systems that will need to 

be modified to track and report on the 

new meaningful use requirements for 

provider attestations. We are providing 

90 percent FFP to States for modifying 

their existing EHR Incentive Program 

systems. We believe the Federal share of 

the 90 percent match will protect the 

States from burdensome financial 

outlays and, as noted previously, States 

offer the Medicaid EHR incentive 

program at their option. 

2. Effects on Eligible Professionals, 

Eligible Hospitals, and CAHs 

a. Background and Assumptions 

The principal costs of this final rule 

are the additional expenditures that will 

be undertaken by eligible entities in 

order to obtain the Medicare and 

Medicaid incentive payments to adopt, 

implement or upgrade and/or 

demonstrate meaningful use of certified 

EHR technology, and to avoid the 

Medicare payment adjustments that will 

ensue if they fail to do so. The estimates 

for the provisions affecting Medicare 

and Medicaid EPs, eligible hospitals, 

and CAHs are somewhat uncertain for 

several reasons: (1) The program is 

voluntary although payment 

adjustments will be imposed on 

Medicare providers beginning in 2015 if 

they are unable to demonstrate 

meaningful use for the applicable 

reporting period; (2) the Stage 1 and 

Stage 2 criteria for the demonstration of 

meaningful use of CEHRT has been 

finalized, but will change in Stage 3 and 

over time; and (3) the impact of the 

financial incentives and payment 

adjustments on the rate of adoption of 

certified EHR technology by EPs, 

eligible hospitals, and CAHs is difficult 

to predict based on the information we 

have currently collected. The net costs 

and savings shown for this program 

represent a possible scenario and actual 

impacts could differ substantially. 

Based on input from a number of 

internal and external sources, including 

the Government Accountability Office 

(GAO) and CBO, we estimated the 

numbers of EPs and eligible hospitals, 

including CAHs under Medicare, 

Medicaid, and MA and used them 

throughout the analysis. 

• About 568,900 Medicare FFS EPs in 

2014 (some of whom will also be 

Medicaid EPs). 

• About 14 percent of the total EPs 

are hospital-based Medicare EPs, and 

are not eligible for the program. This 

leaves approximately 491,000 

nonhospital-based Medicare EPs in 

2014. 

• About 20 percent of the 

nonhospital-based Medicare EPs 

(approximately 98,200 Medicare EPs in 

2014) are also eligible for Medicaid 

(meet the 30 percent Medicaid patient 

volume criteria), but can only be paid 

under one program. We assume that any 

EP in this situation will choose to 

receive the Medicaid incentive 

payment, because it is larger. 

• About 46,600 non-Medicare eligible 

EPs (such as dentists, pediatricians, and 

eligible nonphysicians such as certified 

nurse-midwives, nurse practitioners and 

physicians assistants) will be eligible to 

receive the Medicaid incentive 

payments. 

• 4,993 eligible hospitals comprised 

of the following: 

++ 3,573 acute care hospitals. 

++ 1,325 CAHs. 

++ 84 children’s hospitals (Medicaid 

only). 

++ 11 cancer hospitals (Medicaid 

only). 

• All eligible hospitals, except for 

children’s and cancer hospitals, may 

qualify and apply for both Medicare and 

Medicaid incentive payments. 

• 12 MA organizations (about 28,000 

EPs, and 29 hospitals) will be eligible 

for incentive payments. 

b. Industry Costs and Adoption Rates 

In the Stage 1 final rule (75 FR 44545 

through 44547), we estimated the 

impact on healthcare providers using 

information from the same four studies 

cited previously in this final rule. Based 

on these studies and current average 

costs for available certified EHR 

technology products, we continue to 

estimate for EPs that the average adopt/ 

implement/upgrade cost is $54,000 per 

physician FTE, while annual 

maintenance costs average $10,000 per 

physician FTE. 

For all eligible hospitals, the range is 

from $1 million to $100 million. 

Although reports vary widely, we 

anticipate that the average will be $5 

million to achieve meaningful use, 

because providers who will like to 

qualify as meaningful users of EHRs will 

need to purchase certified EHRs. We 

further acknowledge ‘‘certified EHRs’’ 

may differ in many important respects 

from the EHRs currently in use and may 

differ in the functionalities they contain. 

We estimate $1 million for maintenance, 

upgrades, and training each year. Both 

of these estimates are based on average 

figures provided in the 2008 CBO 

report. Industry costs are important, in 

part, because EHR adoption rates will be 

a function of these industry costs and 

the extent to which the costs of 

‘‘certified EHRs’’ are higher than the 

total value of EHR incentive payments 

available to EPs and eligible hospitals 

(as well as adjustments, in the case of 

the Medicare EHR incentive program) 

and any perceived benefits including 

societal benefits. Because of the 

uncertainties surrounding industry cost 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54139 

estimates, we have made various 

assumptions about adoption rates in the 

following analysis in order to estimate 

the budgetary impact on the Medicare 

and Medicaid programs. 

c. Costs of EHR Adoption for EPs 

Since the publication of the Stage 1 

final rule, there has been little data 

published regarding the cost of EHR 

adoption and implementation. A 2011 

study (http://content.healthaffairs.org/ 

content/30/3/481.abstract) estimated 

costs of implementation for a fivephysician practice to be $162,000, with 

$85,500 in maintenance expenses in the 

first year. These estimates are similar to 

estimates made in the Stage 1 final rule. 

In the absence of additional data 

regarding the cost of adoption and 

implementation costs for certified EHR 

technology, we proposed to continue to 

estimate for EPs that the average adopt/ 

implement/upgrade cost is $54,000 per 

physician FTE, while annual 

maintenance costs average $10,000 per 

physician FTE, based on the cost 

estimate of the Stage 1 final rule. 

Comment: Some commenters 

suggested that specific costs and 

financial gains for each provider be 

recorded as part of attestation to inform 

the overall impact analysis. Another 

commenter suggested that the analysis 

should include costs associated with 

unintended consequences of the 

regulation, such as the loss of revenue 

to providers through the elimination of 

unnecessary or duplicative tests and the 

resistance of the market to improving 

patient care under such circumstances. 

The commenter also suggested that the 

impact analysis should be stratified 

according to primary care and specialty 

providers. 

Response: Although we agree that a 

system that records the specific costs 

and benefits for each provider would 

yield a more accurate financial analysis, 

we believe that such a requirement 

would place a significant burden on 

providers and potentially limit 

participation in the EHR Incentive 

Programs. We also do not believe that 

there is an accurate method to calculate 

the loss of revenue due to the 

elimination of unnecessary or 

duplicative tests or market resistance to 

improving patient care. The reduction of 

costs while improving patient care is 

one of the goals of the EHR Incentive 

Programs, and we do not believe that 

these reductions should be classified as 

negative impacts for the healthcare 

system as they would also lead to lower 

overall health care costs. Nor do we 

believe it is possible for us to 

proactively estimate such savings at this 

time. Because both primary-care and 

specialty providers receive the same 

incentive payment amounts under this 

program, we do not believe there is a 

benefit to stratifying the impact analysis 

in this way. 

d. Costs of EHR Adoption for Eligible 

Hospitals 

AHA conducts annual surveys that 

among other measures, track hospital 

spending. This data reflects the latest 

figures from the 2008 AHA Survey. 

Costs at these levels of adoption were 

significantly higher in 2008 than in 

previous years. This may better reflect 

the costs of implementing additional 

functionalities. The range in yearly 

information technology spending among 

hospitals is large, from $36,000 to over 

$32 million based on the AHA data. 

EHR system costs specifically were 

reported by experts to run as high as $20 

million to $100 million. HHS 

discussions with experts led to cost 

ranges for adoption that varied by 

hospital size and level of EHR system 

sophistication. Research to date has 

shown that adoption of comprehensive 

EHR systems is limited. In the 

aforementioned AHA study, 1.5 percent 

of these organizations had 

comprehensive systems, which were 

defined as hospital-wide clinical 

documentation of cases, test results, 

prescription and test ordering, plus 

support for decision-making that 

included treatment guidelines. Some 

10.9 percent have a basic system that 

does not include physician and nursing 

notes, and can only be used in one area 

of the hospital. Applying a similar 

standard to the 2008 AHA data, results 

in roughly 3 to 4 percent of hospitals 

having comprehensive systems and 12 

to 13 percent having basic systems. 

According to hospital CEOs, the main 

barrier to adoption is the cost of the 

systems, and the lack of capital. 

Hospitals have been concerned that they 

will not be able to recoup their 

investment, and they are already 

operating on limited margins. Because 

uptake of advanced systems is low, it is 

difficult to get a solid average estimate 

for implementation and maintenance 

costs that can be applied across the 

industry. In addition, we recognize that 

there are additional industry costs 

associated with adoption and 

implementation of EHR technology that 

are not captured in our estimates that 

eligible entities will incur. Because the 

impact of those activities, such as 

reduced staff productivity related to 

learning how to use the EHR 

technology, the need to add additional 

staff to work with HIT issues, and 

administrative costs related to reporting 

are unknown at this time and difficult 

to quantify. 

Comment: Some commenters 

suggested that overall IT operating costs 

should be included as part of the 

analysis. These commenters also 

suggested that estimates for costs related 

to staff training were too low and should 

include time and resources devoted to 

understanding the EHR Incentive 

Programs regulations. Other 

commenters suggested that costs 

associated with the time and resources 

related to registration and attestation 

should be included as part of the 

analysis. Finally, some commenters 

suggested that costs associated with 

EHR products, consultants, and trained 

IT professionals have increased since 

the start of the EHR Incentive Programs 

and should be reflected in the analysis. 

Response: As noted in this impact 

analysis, we based cost estimates for IT 

on peer-reviewed studies of EHR and 

health IT costs. These cost estimates 

included maintenance and operating 

costs specific to EHRs and staff training. 

There are many aspects of IT operating 

costs that are not directly related to the 

maintenance or operation of CEHRT, 

and we do not believe it would be 

appropriate to include those costs as 

part of the impact analysis of this 

regulation. We are not aware of any new 

data that suggests an overall increase in 

the costs of CEHRT or related 

implementation and maintenance costs 

since the start of the EHR Incentive 

Programs, and in many cases we believe 

that the product and maintenance costs 

of CEHRT can be significantly lower 

than our estimates. Therefore, we are 

continuing to use the estimates we 

proposed for this impact analysis. We 

also do not believe it is appropriate to 

include additional costs related to 

registration and attestation, as the cost 

for dedicating resources to these 

activities is addressed earlier in this 

final rule in our discussion of 

information collection requirements. 

3. Medicare Incentive Program Costs 

a. Medicare Eligible Professionals (EPs) 

We continue the method of cost 

estimation we used to determine the 

estimated costs of the Medicare 

incentives for EPs in our Stage 1 final 

rule (75 FR 44549). In order to 

determine estimated costs, we first 

needed to determine the EPs with 

Medicare claims. Then, we calculated 

that about 14 percent of those EPs are 

hospital based according to the 

definition in § 495.4 (finalized in our 

Stage 1 final rule), and therefore, do not 

qualify for incentive payments. This 

percent of EPs was subtracted from the 

mstockstill on DSK4VPTVN1PROD with RULES2

54140 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

total number of EPs who have claims 

with Medicare. These numbers were 

tabulated from Medicare claims data. 

In the Stage 1 final rule, we also 

estimated that about 20 percent of EPs 

that were not hospital based will qualify 

for Medicaid incentive payments and 

will choose that program because the 

payments are higher. Current program 

data does not provide additional 

evidence regarding this, so we 

continued to use the 20 percent 

estimation in the current projections. Of 

the remaining EPs, we estimated the 

percentage which will be meaningful 

users each calendar year. As discussed 

previously, our estimates for the number 

of EPs that will successfully 

demonstrate meaningful use of CEHRT 

are uncertain. The percentage of 

Medicare EPs who will satisfy the 

criteria for demonstrating meaningful 

use of CEHRT and will qualify for 

incentive payments is a key, but a 

highly uncertain factor. Accordingly, 

the estimated number of nonhospital 

based Medicare EPs who will 

demonstrate meaningful use of CEHRT 

over the period CYs 2014 through 2019 

is as shown in Table 22. 

TABLE 22—MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY

Calendar year 

2014 2015 2016 2017 2018 2019 

EPs who have claims with Medicare (thousands) 568 .9 574 .8 580 .8 586 .8 592 .7 598 .6 

Nonhospital Based EPs (thousands) ................... 491 .0 496 .1 501 .3 506 .4 511 .5 516 .7 

EPs that are both Medicare and Medicaid EPs 

(thousands) ....................................................... 98 .2 99 .2 100 .3 101 .3 102 .3 103 .3 

Percent of EPs who are Meaningful Users ......... 37 46 52 57 62 67 

Meaningful Users (thousands) ............................. 147 .1 184 .2 206 .5 229 .3 252 .5 276 .1 

Our estimates of the incentive 

payments and payment adjustment 

savings are presented in Table 23. These 

payments reflect the Medicare and 

Medicaid incentive payments and 

payment adjustments included in 42 

CFR Part 495 of our regulations. They 

reflect our assumptions about the 

proportion of EPs who will demonstrate 

meaningful use of CEHRT. These 

assumptions were developed based on a 

review of the studies presented in the 

Stage 1 impact analysis. 

Specifically, our assumptions are 

based on literature estimating current 

rates of physician EHR adoption and 

rates of diffusion of EHRs and similar 

technologies. There are a number of 

studies that have attempted to measure 

the rate of adoption of electronic 

medical records (EMR) among 

physicians prior to the enactment of the 

HITECH Act (see, for example, Funky 

and Taylor (2005) The State and Pattern 

of Health Information Technology 

Adoption. RAND Monograph MG–409. 

Santa Monica: The RAND Corporation; 

Ford, E.W., Menachemi, N., Peterson, 

L.T., Huerta, T.R. (2009) ‘‘Resistance is 

Futile: But it is Slowing the Pace of EHR 

Adoption Nonetheless’’ Journal of the 

American Informatics Association 16(3): 

274–281). More recently, there is also 

some data available to suggest that more 

providers have adopted EHR technology 

since the start of the EHR Incentive 

Programs. The 2011 ONC–AHA survey 

cited earlier found that the percentage of 

U.S. hospitals which had adopted EHRs 

increased from 16 to 35 percent between 

2009 and 2011. In November 2011, the 

CDC survey cited earlier found the 

percentage of physicians who adopted 

basic (EHRs in their practice had 

doubled from 17 to 34 percent between 

2008 and 2011. These survey results are 

in line with the estimated rate of EHR 

adoption presented in the Stage 1 

impact analysis, but they constitute a 

relatively small sample on which to 

base new estimates. Therefore we 

maintain the estimates that were based 

on the study with the most rigorous 

definition, though we note again that 

neither the Stage 1 nor the Stage 2 

meaningful use criteria are equivalent to 

a fully functional system as defined in 

this study. (DesRoches, CM, Campbell, 

EG, Rao, SR et al (2008) ‘‘Electronic 

Health Records in Ambulatory Care-A 

National Survey of Physicians’’ New 

England Journal of Medicine 359(1): 50– 

60. In addition, we note that the final 

penetration rates used in the initial 

estimates were developed in consensus 

with industry experts relying on the 

studies. Actual adoption trends could be 

different from these assumptions, given 

the elements of uncertainty we describe 

throughout this analysis. 

Estimated net costs of the Medicare 

EP portion of the HITECH Act are 

shown in Table 23. 

TABLE 23—ESTIMATED COSTS (+) AND SAVINGS (¥) FOR MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF

CERTIFIED EHR TECHNOLOGY

[In billions] 

Fiscal year 

Incentive 

payments 

($) 

Payment 

adjustment 

receipts 

Benefit 

payments 

Net total 

($) 

2014 ................................................................................................................................. 1.9 .................... .................... 1.9 

2015 ................................................................................................................................. 2.0 ¥0.1 .................... 1.9 

2016 ................................................................................................................................. 0.8 ¥0.1 .................... 0.6 

2017 ................................................................................................................................. 0.3 ¥0.2 .................... 0.1 

2018 ................................................................................................................................. .................... ¥0.2 .................... ¥0.2 

2019 ................................................................................................................................. .................... ¥0.2 .................... ¥0.2 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54141 

b. Medicare Eligible Hospitals and 

CAHs 

In brief, the estimates of hospital 

adoption were developed by calculating 

projected incentive payments (which 

are driven by discharges), comparing 

them to projected costs of attaining 

meaningful use, and then making 

assumptions about how rapidly 

hospitals will adopt given the fraction of 

their costs that were covered. 

Specifically, the first step in preparing 

estimates of Medicare program costs for 

eligible hospitals was to determine the 

amount of Medicare incentive payments 

that each hospital in the country could 

potentially receive under the statutory 

formula, based on its discharge numbers 

(total patients and Medicare patients). 

The total incentive payments potentially 

payable over a 4-year period vary 

significantly by hospitals’ inpatient 

caseloads, ranging from a low of about 

$11,000 to a high of $12.9 million, with 

the median being $3.8 million. The 

potential Medicare incentive payments 

for each eligible hospital were compared 

with the hospital’s expected cost of 

purchasing and operating certified EHR 

technology. Costs of adoption for each 

hospital were estimated using data from 

the 2009 AHA survey and IT 

supplement. Estimated costs varied by 

size of hospital and by the likely status 

of EHR adoption in that class of 

hospitals. Hospitals were grouped first 

by size (CAHs, non-CAH hospitals 

under 400 beds, and hospitals with 400 

or more beds) because EHR adoption 

costs do vary by size: namely, larger 

hospitals with more diverse service 

offerings and large physician staffs 

generally implement more customized 

systems than smaller hospitals that 

might purchase off-the-shelf products. 

We then calculated the proportion of 

hospitals within each class that were at 

one of three levels of EHR adoption: (1) 

Hospitals which had already 

implemented relatively advanced 

systems that included CPOE systems for 

medications; (2) hospitals which had 

implemented more basic systems 

through which lab results could be 

shared, but not CPOE for medications; 

and (3) hospitals starting from a base 

level with neither CPOE or lab 

reporting. The CPOE for medication 

standard was chosen for this estimate 

because expert input indicated that the 

CPOE standard in the final meaningful 

use definition will be the hardest one 

for hospitals to meet. Table 24 provides 

these proportions. 

TABLE 24—HOSPITAL IT CAPABILITIES BY HOSPITAL SIZE

Hospital size 

Levels of adoption 

Any CPOE meds Lab results Neither Total 

Number of 

hospitals Percentage Number of hospitals Percentage Number of hospitals Percentage Number of hospitals Percentage 

CAHs ................................ 169 22 390 51 210 27 769 23 

Small/Medium .................. 834 37 1,051 47 348 16 2,233 67 

Large (400+ beds) ........... 200 56 145 41 10 3 355 10 

Total .......................... 1,203 36 1,586 47 568 17 3,357 100 

We then calculated the costs of 

moving from these stages to meaningful 

use for each class of hospital, assuming 

that even for hospitals with CPOE 

systems they will incur additional costs 

of at least 10 percent of their IT budgets. 

These costs were based on crosssectional data from the AHA survey and 

thus do not likely represent the true 

costs of implementing systems. This 

data reflects the latest figures from the 

2009 AHA Survey. Costs at these levels 

of adoption were significantly higher 

than in previous years. This may better 

reflect the costs of implementing 

additional functionalities. We have also 

updated the number of discharges using 

the most recent cost report data 

available. The payment incentives 

available to hospitals under the 

Medicare and Medicaid programs are 

included in our regulations at 42 CFR 

part 495. We estimate that there are 12 

MAOs that might be eligible to 

participate in the incentive program. 

Those plans have 29 eligible hospitals. 

The costs for the MA program have been 

included in the overall Medicare 

estimates. 

Our estimated net costs for section 

4102 of the HITECH Act are shown in 

Table 25: Estimated costs (+) and 

savings (–) for eligible hospitals 

adopting certified EHRs. This provision 

is estimated to increase Medicare 

hospital expenditures by a net total of 

$5.3 billion during FYs 2014 through 

2019. 

TABLE 25—ESTIMATED COSTS (+) AND SAVINGS (¥) FOR MEDICARE ELIGIBLE HOSPITALS DEMONSTRATING MEANINGFUL

USE OF CERTIFIED EHR TECHNOLOGY

[In billions] 

Fiscal year Incentive 

payments 

Payment 

adjustment 

receipts 

Benefit 

payments Net total 

2014 ................................................................................................................................. $2.1 .................... (1) $2.1 

2015 ................................................................................................................................. 2.2 ¥0.4 (1) 1.8 

2016 ................................................................................................................................. 1.7 ¥0.5 (1) 1.2 

2017 ................................................................................................................................. 0.5 ¥0.3 (1) 0.2 

2018 ................................................................................................................................. .................... ¥0.1 (1) ¥0.1 

2019 ................................................................................................................................. .................... .................... (1) (1) 

1Savings of less than $50 million. 

mstockstill on DSK4VPTVN1PROD with RULES2

54142 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

Based on the comparison of Medicare 

incentive payments and 

implementation/operating costs for each 

eligible hospital (described previously), 

we made the assumptions shown in 

Table 25, related to the prevalence of 

CEHRT for FYs 2014 through 2018. 

These assumptions are consistent with 

the actual program data for 2011. As 

indicated, eligible hospitals that could 

cover the full cost of an EHR system 

through Medicare incentive payments 

were assumed to implement them 

relatively rapidly, and vice versa. In 

other words, eligible hospitals will have 

an incentive to purchase and implement 

an EHR system if they perceive that a 

large portion of the costs will be covered 

by the incentive payments. Table 26 

shows the assumptions that were used. 

TABLE 26—ASSUMED PROPORTION OF ELIGIBLE HOSPITALS WITH CERTIFIED EHR TECHNOLOGY, BY PERCENTAGE OF

SYSTEM COST COVERED BY MEDICARE INCENTIVE PAYMENTS

Fiscal year 

Incentive payments as percentage of EHR technology cost 

100+% 75–100% 50–75% 25–50% 0–25% 

2014 ................................................................................................. 1.0 0 .95 0 .85 0 .5 0 .3 

2015 ................................................................................................. 1.0 1 .0 0 .95 0 .75 0 .5 

2016 ................................................................................................. 1.0 1 .0 1 .0 0 .9 0 .75 

2017 ................................................................................................. 1.0 1 .0 1 .0 1 .0 0 .9 

2018 ................................................................................................. 1.0 1 .0 1 .0 1 .0 1 .0 

For instance, 95 percent of eligible 

hospitals whose incentive payments 

will cover between 75 percent and 100 

percent of the cost of a certified EHR 

system were assumed to have a certified 

system in FY 2014. All such hospitals 

were assumed to have a certified EHR 

system in FY 2015 and thereafter. 

High rates of EHR adoption are 

anticipated in the years leading up to 

FY 2015 due to the payment 

adjustments that will be imposed on 

eligible hospitals. However, we know 

from industry experts that issues 

surrounding the capacity of vendors and 

expert consultants to support 

implementation, issues of access to 

capital, and competing priorities in 

responding to payer demand will limit 

the number of hospitals that can adopt 

advanced systems in the short term. 

Therefore, we cannot be certain of the 

adoption rate for hospitals due to these 

factors and others previously outlined 

in this preamble. 

For large, organized facilities such as 

hospitals, we believe that the revenue 

losses caused by these payment 

adjustments will be a substantial 

incentive to adopt certified EHR 

technology, even in instances where the 

Medicare incentive payments will cover 

only a portion of the costs of 

purchasing, installing, populating, and 

operating the EHR system. Based on the 

assumptions about incentive payments 

as percentages of EHR technology costs 

in Table 26, we estimated that the great 

majority of eligible hospitals will 

qualify for at least a portion of the 

Medicare incentive payments that they 

could potentially receive, and only a 

modest number will incur payment 

adjustments. Nearly all eligible 

hospitals are projected to have 

implemented CEHRT by FY 2019. Table 

27 shows our estimated percentages of 

the total potential incentive payments 

associated with eligible hospitals that 

could demonstrate meaningful use of 

EHR systems. Also shown are the 

estimated percentages of potential 

incentives that will actually be paid 

each year. 

TABLE 27—ESTIMATED PERCENTAGE

OF MEDICARE INCENTIVES WHICH

COULD BE PAID FOR MEANINGFUL

USE OF CERTIFIED EHR TECHNOLOGY ASSOCIATED WITH ELIGIBLE

HOSPITALS AND ESTIMATED PERCENTAGE PAYABLE IN YEAR

Fiscal year 

Percent 

associated 

with eligible 

hospitals 

Percent 

payable in 

year 

2014 .................. 66.1 66.1 

2015 .................. 80.2 72.2 

2016 .................. 91.3 48.8 

2017 .................. 97.7 ....................

2018 .................. 100.0 ....................

For instance in FY 2014, 66.1 percent 

of the total amount of incentive 

payments which could be payable in 

that year will be for eligible hospitals 

who have demonstrated meaningful use 

of CEHRT and therefore will be paid. In 

FY 2015, 80.2 percent of the total 

amount of incentive payments which 

could be payable will be for hospitals 

who have certified EHR systems, but 

some of those eligible hospitals will 

have already received 4 years of 

incentive payments, and therefore 72.2 

percent of all possible incentive 

payments actually paid in that year. 

The estimated payments to eligible 

hospitals were calculated based on the 

hospitals’ qualifying status and 

individual incentive amounts under the 

statutory formula. Similarly, the 

estimated payment adjustments for 

nonqualifying hospitals were based on 

the market basket reductions and 

Medicare revenues. The estimated 

savings in Medicare eligible hospital 

benefit expenditures resulting from the 

use of hospital certified EHR systems 

are discussed under ‘‘general 

considerations’’ at the end of this 

section. We assumed no future growth 

in the total number of hospitals in the 

U.S. because growth in acute care 

hospitals has been minimal in recent 

years. 

c. Critical Access Hospitals (CAHs) 

We estimate that there are 1,325 CAHs 

eligible to receive EHR incentive 

payments. In the Stage 1 impact 

analysis, we estimated that the 22 

percent of CAHs with relatively 

advanced EHR systems will achieve 

meaningful use before 2016 given on the 

financial assistance available under 

HITECH for Regional Extension Centers, 

whose priorities include assisting CAHs 

in EHR adoption. We also estimated that 

most of the remaining CAHs that had 

already adopted some kind of EHR 

system at that time (51 percent of CAHs) 

will also achieve meaningful use by 

2016. Current program payment data, as 

well as current data from the Regional 

Extension Centers, provides some more 

information for us to alter these 

estimates. Our new estimates regarding 

the incentives that will be paid to CAHs 

are incorporated into the overall 

Medicare and Medicaid program costs. 

4. Medicaid Incentive Program Costs 

Under section 4201 of the HITECH 

Act, states can voluntarily participate in 

the Medicaid incentive payment 

program. However, as of the writing of 

this final rule 48 states are already 

participating in the Medicaid incentive 

payment program and the remaining 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54143 

states have indicated they will begin 

participation in 2012. Therefore we 

anticipate that all states will be 

participating by 2014, as we estimated 

in the Stage 1 impact analysis. The 

payment incentives available to EPs and 

hospitals under the Medicaid programs 

are included in our regulations at 42 

CFR part 495. The Federal costs for 

Medicaid incentive payments to 

providers who can demonstrate 

meaningful use of EHR technology were 

estimated similarly to the estimates for 

Medicare eligible hospital and EP. Table 

28 shows our estimates for the net 

Medicaid costs for eligible hospitals and 

EPs. 

TABLE 28—ESTIMATED FEDERAL COSTS (+) AND SAVINGS (¥) UNDER MEDICAID

[In billions] 

Fiscal year 

Incentive payments 

Benefit payments Net total 

Hospitals Eligible 

professionals 

2014 ......................................................................................... 0.6 0.5 (1) 1.1 

2015 ......................................................................................... 0.4 0.8 (1) 1.2 

2016 ......................................................................................... 0.5 0.8 (1) 1.2 

2017 ......................................................................................... 0.5 0.7 (1) 1.2 

2018 ......................................................................................... 0.1 0.7 (1) 0.8 

2019 ......................................................................................... 0.0 0.5 (1) 0.5 

1Savings of less than $50 million. 

a. Medicaid EPs 

To determine the Medicaid EP 

incentive payments, we first determined 

the number of qualifying EPs. As 

indicated previously, we assumed that 

20 percent of the nonhospital-based 

Medicare EPs will meet the 

requirements for Medicaid incentive 

payments (30 percent of patient volume 

from Medicaid). All of these EPs were 

assumed to choose the Medicaid 

incentive payments, as they are larger. 

In addition, the total number of 

Medicaid EPs was adjusted to include 

EPs who qualify for the Medicaid 

incentive payments but not for the 

Medicare incentive payments, such as 

most pediatricians, dentists, certified 

nurse-midwives, nurse practitioners, 

and physicians assistants. As noted 

previously, there is much uncertainty 

about the rates of demonstration of 

meaningful use that will be achieved. 

Our estimates are listed in Table 29. 

TABLE 29—ASSUMED NUMBER OF NONHOSPITAL-BASED MEDICAID EPS WHO WILL BE MEANINGFUL USERS OF

CERTIFIED EHR TECHNOLOGY

[All population figures are in thousands] 

Calendar year 

2014 2015 2016 2017 2018 2019 

EPs who have claims with Medicare ....................... 568.9 574.8 580.8 586.8 592.7 598.6 

Nonhospital-based EPs ........................................... 491.0 496.1 501.3 506.4 511.5 516.7 

A EPs who meet the Medicaid patient volume threshold.98.2 99.2 100.3 101.3 102.3 103.3 

B Medicaid 1 only EPs ................................................. 46.6 47.4 48.1 48.9 49.7 50.4 

Total Medicaid EPs (A + B) ..................................... 144.8 146.6 148.4 150.2 152.0 153.8 

Percent of EPs receiving incentive payment during 

year.

49.2% 58.8% 64.0% 52.9% 29.5% 22.6% 

Number of EPs receiving incentive payment during 

year.

71.2 86.3 95.0 79.4 44.8 34.8 

Percent of EPs who have ever received incentive 

payment.

49.2% 58.8% 64.0% 68.9% 73.5% 77.9% 

Number of EPs who have ever received incentive 

payment.

71.2 86.3 95.0 103.4 111.7 119.8 

It should be noted that since the 

Medicaid EHR incentive payment 

program provides that a Medicaid EP 

can receive an incentive payment in 

their first year because he or she has 

demonstrated a meaningful use or 

because he or she has adopted, 

implemented, or upgraded certified EHR 

technology, these participation rates 

include not only meaningful users but 

eligible providers implementing CEHRT 

as well. 

b. Medicaid Hospitals 

Medicaid incentive payments to most 

acute-care hospitals were estimated 

using the same adoption assumptions 

and method as described previously for 

Medicare eligible hospitals and shown 

in Table 30. Because hospitals’ 

Medicare and Medicaid patient loads 

differ, we separately calculated the 

range of percentage of total potential 

incentives that could be associated with 

qualifying hospitals, year by year, and 

the corresponding actual percentages 

payable each year. Acute care hospitals 

may qualify to receive both the 

Medicare and Medicaid incentive 

payments. 

As stated previously, the estimated 

eligible hospital incentive payments 

were calculated based on the hospitals’ 

qualifying status and individual 

incentive amounts payable under the 

statutory formula. The estimated savings 

in Medicaid benefit expenditures 

resulting from the use of CEHRT are 

discussed under ‘‘general 

considerations.’’ Since we were using 

mstockstill on DSK4VPTVN1PROD with RULES2

54144 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

Medicare cost report data and little data 

existed for children’s hospitals, we 

estimated the Medicaid incentives 

payable to children’s hospitals as an 

add-on to the base estimate, using data 

on the number of children’s hospitals 

compared to nonchildren’s hospitals. 

TABLE 30—ESTIMATED PERCENTAGE

OF POTENTIAL MEDICAID INCENTIVES

ASSOCIATED WITH ELIGIBLE HOSPITALS AND ESTIMATED PERCENTAGE PAYABLE EACH YEAR

Fiscal year 

Percent 

associated 

with eligible 

hospitals 

Percent 

payable in 

year 

2014 .................. 67.5 59.3 

2015 .................. 81.1 37.9 

2016 .................. 91.8 33.7 

2017 .................. 97.7 24.3 

2018 .................. 100.0 10.7 

2019 .................. 100.0 0.0 

5. Benefits for All EPs and All Eligible 

Hospitals 

In this final rule we have not 

quantified the overall benefits to the 

industry, nor to eligible hospitals or EPs 

in the Medicare, Medicaid, or MA 

programs. Although information on the 

costs and benefits of adopting systems 

that specifically meet the requirements 

for the EHR Incentive Programs (for 

example, certified EHR technology) has 

not yet been collected, and although 

some studies question the benefits of 

health information technology, a 2011 

study completed by ONC (Buntin et al. 

2011 ‘‘The Benefits of Health 

Information Technology: A Review of 

the Recent Literature Shows 

Predominantly Positive Results’’ Health 

Affairs.) found that 92 percent of 154 

articles published from July 2007 up to 

February 2010 reached conclusions that 

showed the overall positive effects of 

health information technology on key 

aspects of care, including quality and 

efficiency of health care. Among the 

positive results highlighted in these 

articles were decreases in patient 

mortality, reductions in staffing needs, 

correlation of clinical decision support 

to reduced transfusion and costs, 

reduction in complications for patients 

in hospitals with more advanced health 

IT, and a reduction in costs for hospitals 

with less advanced health IT. Another 

study, at one hospital emergency room 

in Delaware, showed the ability to 

download and create a file with a 

patient’s medical history saved the ER 

$545 per use, mostly in reduced waiting 

times. A pilot study of ambulatory 

practices found a positive ROI within 16 

months and annual savings thereafter 

(Greiger, et al. 2007, A Pilot Study to 

Document the Return on Investment for 

Implementing an Ambulatory Electronic 

Health Record at an Academic Medical 

Center http://www.journalacs.org/ 

article/S1072-7515%2807%2900390-0/ 

abstract-article-footnote-1s.) A study 

that compared the productivity of 75 

providers within a large urban primary 

care practice over a 4-year period 

showed increases in productivity of 1.7 

percent per month per provider after 

EHR adoption (DeLeon et al. 2010, ‘‘The 

business end of health information 

technology. Can a fully integrated 

electronic health record increase 

provider productivity in a large 

community practice?’’ J Med Pract 

Manage). Some vendors have estimated 

that EHRs could result in cost savings of 

between $100 and $200 per patient per 

year. At the time of the writing of this 

final rule, there was only limited 

information on participation in the EHR 

Incentive Programs and on adoption of 

Certified EHR Technology. As 

participation and adoption increases, 

there will be more opportunities to 

capture and report on cost savings and 

benefits. A number of relevant studies 

are required in the HITECH Act for this 

specific purpose, and the results will be 

made public, as they are available. 

6. Benefits to Society 

According to the recent CBO study 

‘‘Evidence on the Costs and Benefits of 

Health Information Technology’’ (http:// 

www.cbo.gov//ftpdocs/91xx/doc9168/

05-20-HealthIT.pdf) when used 

effectively, EHRs can enable providers 

to deliver health care more efficiently. 

For example, the study states that EHRs 

can reduce the duplication of diagnostic 

tests, prompt providers to prescribe 

cost-effective generic medications, 

remind patients about preventive care 

reduce unnecessary office visits and 

assist in managing complex care. This is 

consistent with the findings in the ONC 

study cited previously. Further, the CBO 

report claims that there is a potential to 

gain both internal and external savings 

from widespread adoption of health IT, 

noting that internal savings will likely 

be in the reductions in the cost of 

providing care, and that external savings 

could accrue to the health insurance 

plan or even the patient, such as the 

ability to exchange information more 

efficiently. However, it is important to 

note that the CBO identifies the highest 

gains accruing to large provider systems 

and groups and claims that office-based 

physicians may not realize similar 

benefits from purchasing health IT 

products. At this time, there is limited 

data regarding the efficacy of health IT 

for smaller practices and groups, and 

the CBO report notes that this is a 

potential area of research and analysis 

that remains unexamined. The benefits 

resulting specifically from this final rule 

are even harder to quantify because they 

represent, in many cases, adding 

functionality to existing systems and 

reaping the network externalities 

created by larger numbers of providers 

participating in information exchange. 

Since the CBO study, there has been 

additional research that has emerged 

documenting the association of EHRs 

with improved outcomes among 

diabetics (Hunt, JS et al. (2009) ‘‘The 

impact of a physician-directed health 

information technology system on 

diabetes outcomes in primary care: A 

pre- and post-implementation study’’ 

Informatics in Primary Care 17(3):165– 

74; Pollard, C et al. (2009) ‘‘Electronic 

patient registries improve diabetes care 

and clinical outcomes in rural 

community health centers’’ Journal of 

Rural Health 25(1):77–84) and trauma 

patients (Deckelbaum, D. et al. (2009) 

‘‘Electronic medical records and 

mortality in trauma patients’’ The 

Journal of Trauma: Injury, Infection, and 

Critical Care 67(3): 634–636), enhanced 

efficiencies in ambulatory care settings 

(Chen, C et al. (2009) ‘‘The Kaiser 

Permanente Electronic Health Record: 

Transforming and Streamlining 

Modalities of Care.’’Health Affairs 

28(2):323–333), and improved outcomes 

and lower costs in hospitals 

(Amarasingham, R. et al. (2009) 

‘‘Clinical information technologies and 

inpatient outcomes: A multiple hospital 

study’’ Archives of Internal Medicine 

169(2):108–14). However, data relating 

specifically to the EHR Incentive 

Programs is limited at this time. 

7. General Considerations 

The estimates for the HITECH Act 

provisions were based on the economic 

assumptions underlying the President’s 

2013 Budget. Under the statute, 

Medicare incentive payments for 

CEHRT are excluded from the 

determination of MA capitation 

benchmarks. As noted previously, there 

is considerable uncertainty about the 

rate at which eligible hospitals, CAHs 

and EPs are adopting EHRs and other 

HIT. Nonetheless, we believe that the 

Medicare incentive payments and the 

prospect of significant payment 

adjustments for not demonstrating 

meaningful use will result in the great 

majority of hospitals implementing 

CEHRT in the early years of the 

Medicare EHR incentive program. We 

expect that a steadily growing 

proportion of practices will implement 

CEHRT over the next 10 years, even in 

the absence of the Medicare incentives. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54145 

Actual future Medicare and Medicaid 

costs for eligible hospital and EP 

incentives will depend in part on the 

standards developed and applied for 

assessing meaningful use of certified 

EHR technology. We are administering 

the requirements in such a way as to 

encourage adoption of CEHRT and 

facilitate qualification for incentive 

payments, and expect to adopt 

progressively demanding standards at 

each stage year. Certified EHR 

technology has the potential to help 

reduce medical costs through efficiency 

improvements, such as prompter 

treatments, avoidance of duplicate or 

otherwise unnecessary services, and 

reduced administrative costs (once 

systems are in place), with most of these 

savings being realized by the providers 

rather than by Medicare or Medicaid. To 

the extent that this technology will have 

a net positive effect on efficiency, then 

more rapid adoption of such EHR 

systems will achieve these efficiencies 

sooner than will otherwise occur, 

without the EHR incentives. As noted, 

the possible efficiency savings from the 

adoption of EHR is expected to be 

realized by the providers rather than the 

payers. We expect a negligible impact 

on benefit payments to hospitals and 

EPs from Medicare and Medicaid as a 

result of the implementation of EHR 

technology. 

In the process of preparing the 

estimates for this rule, we consulted 

with and/or relied on internal CMS 

sources, as well as the following 

sources: 

• Congressional Budget Office (staff 

and publications). 

• American Medical Association 

(staff and unpublished data). 

• American Hospital Association. 

• Actuarial Research Corporation. 

• CMS Statistics 2011. 

• RAND Health studies on: 

++ ‘‘The State and Pattern of Health 

Information Technology Adoption’’ 

(Fonkych & Taylor, 2005); 

++ ‘‘Extrapolating Evidence of Health 

Information Technology Savings and 

Costs’’ (Girosi, Meili, & Scoville, 2005); 

and 

++ ‘‘The Diffusion and Value of 

Healthcare Information Technology’’ 

(Bower, 2005). 

• Kaiser Permanente (staff and 

publications). 

• Miscellaneous other sources (Health 

Affairs, American Enterprise Institute, 

ONC survey, Journal of Medical Practice 

Management, news articles and 

perspectives). 

As noted at the beginning of this 

analysis, it is difficult to predict the 

actual impacts of the HITECH Act with 

much certainty. We believe the 

assumptions and methods described 

herein are reasonable for estimating the 

financial impact of the provisions on the 

Medicare and Medicaid programs, but 

acknowledge the wide range of possible 

outcomes. 

8. Summary 

The total cost to the Medicare and 

Medicaid programs between 2014 and 

2019 is estimated to be $15.4 billion in 

transfers. We do not estimate total costs 

to the provider industry, but rather 

provide a possible per EP and per 

eligible hospital outlay for 

implementation and maintenance. 

TABLE 31—ESTIMATED EHR INCENTIVE PAYMENTS AND BENEFITS IMPACTS ON THE MEDICARE AND MEDICAID PROGRAMS

OF THE HITECH EHR INCENTIVE PROGRAM

[Fiscal year]—[In billions] 

Fiscal year 

Medicare eligible Medicaid eligible 

Total 

Hospitals Professionals Hospitals Professionals 

2014 ....................................................... $2.1 $1.9 $0.6 $0.5 $5.1 

2015 ....................................................... 1.8 1.9 0.4 0.8 4.9 

2016 ....................................................... 1.2 0.6 0.5 0.8 3.1 

2017 ....................................................... 0.2 0.1 0.5 0.7 1.5 

2018 ....................................................... ¥0.1 ¥0.2 0.1 0.7 0.5 

2019 ....................................................... .............................. ¥0.2 0.0 0.5 0.3 

9. Explanation of Benefits and Savings 

Calculations 

In our analysis, we assume that 

benefits to the program will accrue in 

the form of savings to Medicare, through 

the Medicare payment adjustments. 

Expected qualitative benefits, such as 

improved quality of care, better health 

outcomes, and the like, are unable to be 

quantified at this time. 

D. Accounting Statement 

Whenever a rule is considered a 

significant rule under Executive Order 

12866, we are required to develop an 

accounting statement indicating the 

classification of the expenditures 

associated with the provisions of this 

final rule. Monetary annualized benefits 

and nonbudgetary costs are presented as 

discounted flows using 3 percent and 7 

percent factors. Additional expenditures 

that will be undertaken by eligible 

entities in order to obtain the Medicare 

and Medicaid incentive payments to 

adopt and demonstrate meaningful use 

of certified EHR technology, and to 

avoid the Medicare payment 

adjustments that will ensue if they fail 

to do so are noted by a placeholder in 

the accounting statement. We are not 

able to explicitly define the universe of 

those additional costs, nor specify what 

the high or low range might be to 

implement EHR technology in this final 

rule. 

Expected qualitative benefits include 

improved quality of care, better health 

outcomes, reduced errors and the like. 

Private industry costs will include the 

impact of EHR activities such as 

temporary reduced staff productivity 

related to learning how to use the EHR, 

the need for additional staff to work 

with HIT issues, and administrative 

costs related to reporting. 

mstockstill on DSK4VPTVN1PROD with RULES2

54146 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

TABLE 32—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES CYS 2014 THROUGH 2019 

[In millions] 

Category 

Benefits 

Qualitative ......................................................................................... Expected qualitative benefits include improved quality of care, better health 

outcomes, reduced errors and the like. 

Costs 

.

Year dollar Estimates 

(in millions) 

Unit 

discount 

rate 

Period 

covered 

Low 

estimate 

High 

Estimate 

Annualized Monetized Costs to Private Industry Associated with 

Reporting Requirements.

2014 $178.0 $186.1 7% CY 2014 

$178.0 $186.1 3% 

Qualitative—Other private industry costs associated with the adoption of EHR technology.These costs will include the impact of EHR activities such as reduced staff 

productivity related to learning how to use the EHR technology, the need for 

additional staff to work with HIT issues, and administrative costs related to 

reporting. 

Transfers 

Year dollar Estimates (in millions) Unit 

discount 

rate 

Period covered 

Federal Annualized Monetized ......................................................... 2014 $2,558 7% CYs 2014–2019 

$2,441 3% 

From Whom To Whom? ................................................................... Federal Government to Medicare- and Medicaid-eligible professionals and 

hospitals. 

E. Conclusion 

The previous analysis, together with 

the remainder of this preamble, 

provides an RIA. We believe there are 

many positive effects of adopting EHR 

on health care providers, quite apart 

from the incentive payments to be 

provided under this rule. We believe 

there are benefits that can be obtained 

by eligible hospitals and EPs, including: 

reductions in medical recordkeeping 

costs, reductions in repeat tests, 

decreases in length of stay, and reduced 

errors. When used effectively, EHRs can 

enable providers to deliver health care 

more efficiently. For example, EHRs can 

reduce the duplication of diagnostic 

tests, prompt providers to prescribe 

cost-effective generic medications, 

remind patients about preventive care, 

reduce unnecessary office visits, and 

assist in managing complex care. We 

also believe that internal savings will 

likely come through the reductions in 

the cost of providing care. While 

economically significant, we do not 

believe that the net effect on individual 

providers will be negative over time 

except in very rare cases. Accordingly, 

we believe that the RFA objective to 

minimize burden on small entities is 

met by this final rule. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

List of Subjects 

42 CFR Part 412 

Administrative practice and 

procedure, Health facilities, Medicare, 

Puerto Rico, Reporting and 

recordkeeping requirements. 

42 CFR Part 413 

Health facilities, Kidney diseases, 

Medicare, Reporting and recordkeeping 

requirements. 

42 CFR Part 495 

Administrative practice and 

procedure, Electronic health records, 

Health facilities, Health professions, 

Health maintenance organizations 

(HMO), Medicaid, Medicare, Penalties, 

Privacy, Reporting and recordkeeping 

requirements. 

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services amends 42 CFR 

chapter IV as set forth below: 

PART 412—PROSPECTIVE PAYMENT 

SYSTEMS FOR INPATIENT HOSPITAL 

SERVICES 

■ 1. The authority citation for part 412 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh). 

Subpart D—Basic Method for 

Determining Prospective Payment 

Federal Rates for Inpatient Operating 

Costs 

■ 2. Section 412.64 is amended as 

follows: 

■ A. Revising paragraph (d)(3) 

introductory text. 

■ B. Adding paragraphs (d)(4) and (5). 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54147 

The revision and addition read as 

follows: 

§ 412.64 Federal rates for inpatient 

operating costs for Federal fiscal year 2005 

and subsequent fiscal years. 

* * * * * 

(d) * * * 

(3) Beginning fiscal year 2015, in the 

case of a ‘‘subsection (d) hospital,’’ as 

defined under section 1886(d)(1)(B) of 

the Act, that is not a meaningful 

electronic health record (EHR) user as 

defined in part 495 of this chapter for 

the applicable EHR reporting period and 

does not receive an exception, threefourths of the applicable percentage 

change specified in paragraph (d)(1) of 

this section is reduced— 

* * * * * 

(4) Exception–(i) General rules. The 

Secretary may, on a case-by-case basis, 

exempt an eligible hospital that is not a 

qualifying eligible hospital from the 

application of the reduction under 

paragraph (d)(3) of this section if the 

Secretary determines that compliance 

with the requirement for being a 

meaningful EHR user would result in a 

significant hardship for the eligible 

hospital. 

(ii) To be considered for an exception, 

a hospital must submit an application, 

in the manner specified by CMS, 

demonstrating that it meets one or more 

than one of the criteria specified in this 

paragraph (d)(4) of this section. These 

types of exceptions are subject to annual 

renewal, but in no case may a hospital 

be granted this type of exception for 

more than 5 years. (See § 495.4 for 

definitions of payment adjustment year, 

EHR reporting period, and meaningful 

EHR user.) 

(A) During any 90-day period from the 

beginning of the fiscal year that is 2 

years before the payment adjustment 

year to April 1 of the year before the 

payment adjustment year, the hospital 

was located in an area without sufficient 

Internet access to comply with the 

meaningful use objectives requiring 

internet connectivity, and faced 

insurmountable barriers to obtaining 

such internet connectivity. Applications 

requesting this exception must be 

submitted by April 1 of the year before 

the applicable payment adjustment year. 

(B)(1) During the fiscal year that is 2 

fiscal years before the payment 

adjustment year, the hospital that has 

previously demonstrated meaningful 

use faces extreme and uncontrollable 

circumstances that prevent it from 

becoming a meaningful EHR user. 

Applications requesting this exception 

must be submitted by April 1 of the year 

before the applicable payment 

adjustment year. 

(2) During the fiscal year preceding 

the payment adjustment year, the 

hospital that has not previously 

demonstrated meaningful use faces 

extreme and uncontrollable 

circumstances that prevent it from 

becoming a meaningful EHR user. 

Applications requesting this exception 

must be submitted by April 1 of the year 

before the applicable payment 

adjustment year. 

(C) The hospital is new in the 

payment adjustment year, and has not 

previously operated (under previous or 

present ownership). This exception 

expires beginning with the first Federal 

fiscal year that begins on or after the 

hospital has had at least one 12-month 

(or longer) cost reporting period after 

they accept their first Medicare covered 

patient. For purposes of this exception, 

the following hospitals are not 

considered new hospitals: 

(1) A hospital that builds new or 

replacement facilities at the same or 

another location even if coincidental 

with a change of ownership, a change in 

management, or a lease arrangement. 

(2) A hospital that closes and 

subsequently reopens. 

(3) A hospital that changes its status 

from a CAH to a hospital that is subject 

to the Medicare hospital inpatient 

prospective payment systems. 

(5) A State in which hospitals are paid 

for services under section 1814(b)(3) of 

the Act must— 

(i) Adjust the payments to each 

eligible hospital in the State that is not 

a meaningful EHR user in a manner that 

is designed to result in an aggregate 

reduction in payments to hospitals in 

the State that is equivalent to the 

aggregate reduction that would have 

occurred if payments had been reduced 

to each eligible hospital in the State in 

a manner comparable to the reduction 

under paragraph (d)(3) of this section; 

and 

(ii) Provide to the Secretary, by 

January 1, 2013, a report on the method 

that it proposes to employ in order to 

make the requisite payment adjustment 

described in paragraph (d)(5)(i) of this 

section. 

* * * * * 

PART 413—PRINCIPLES OF 

REASONABLE COST 

REIMBURSEMENT; PAYMENT FOR 

END-STAGE RENAL DISEASE 

SERVICES; OPTIONAL 

PROSPECTIVELY DETERMINED 

PAYMENT RATES FOR SKILLED 

NURSING FACILITIES 

■ 3. The authority citation for part 413 

continues to read as follows: 

Authority: Secs. 1102, 1812(d), 1814(b), 

1815, 1833(a), (i), and (n), 1861(v), 1871, 

1881, 1883, and 1886 of the Social Security 

Act (42 U.S.C. 1302, 1395d(d), 1395f(b), 

1395g, 1395l(a), (i), and (n), 1395x(v), 

1395hh, 1395rr, 1395tt, and 1395ww); and 

sec. 124 of Public Law 106–133 (113 Stat. 

1501A–332). 

■ 4. Section 413.70 is amended by 

revising paragraphs (a)(6)(i) 

introductory text, (a)(6)(ii), and (a)(6)(iii) 

to read as follows: 

§ 413.70 Payment for services of a CAH. 

(a) * * * 

(6)(i) For cost reporting periods 

beginning in or after FY 2015, if a CAH 

is not a qualifying CAH for the 

applicable EHR reporting period, as 

defined in § 495.4 and § 495.106(a) of 

this chapter, then notwithstanding the 

percentage applicable in paragraph 

(a)(1) of this section, the reasonable 

costs of the CAH in providing CAH 

services to its inpatients are adjusted by 

the following applicable percentage: 

* * * * * 

(ii) The Secretary may on a case-bycase basis, exempt a CAH that is not a 

qualifying CAH from the application of 

the payment adjustment under 

paragraph (a)(6)(i) of this section if the 

Secretary determines that compliance 

with the requirement for being a 

meaningful user would result in a 

significant hardship for the CAH. In 

order to be considered for an exception, 

a CAH must submit an application 

demonstrating that it meets one or more 

of the criteria specified in this 

paragraph (a)(6) for the applicable 

payment adjustment year no later than 

November 30 after the close of the 

applicable EHR reporting period. The 

Secretary may grant an exception for 

one or more of the following: 

(A) During any 90-day period from the 

beginning of the cost reporting period 

that begins in the fiscal year before the 

payment adjustment year to November 

30 after the end of the payment 

adjustment year, the hospital was 

located in an area without sufficient 

Internet access to comply with the 

meaningful use objectives requiring 

Internet connectivity, and faced 

insurmountable barriers to obtaining 

such Internet connectivity. 

(B) A CAH that faces extreme and 

uncontrollable circumstances that 

prevent it from becoming a meaningful 

EHR user during the payment 

adjustment year. 

(C) The CAH is new in the payment 

adjustment year and has not previously 

operated (under previous or present 

ownership). This exception expires 

beginning with the first Federal fiscal 

year that begins on or after the hospital 

mstockstill on DSK4VPTVN1PROD with RULES2

54148 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

has had at least one 12-month (or 

longer) cost reporting period after they 

accept their first Medicare-covered 

patient. For the purposes of this 

exception, the following CAHs are not 

considered new CAHs: 

(1) A CAH that builds new or 

replacement facilities at the same or 

another location even if coincidental 

with a change of ownership, a change in 

management, or a lease arrangement. 

(2) A CAH that closes and 

subsequently reopens. 

(3) A CAH that has been converted 

from an eligible hospital as defined at 

§ 495.4 of this chapter. 

(iii) Exceptions granted under 

paragraph (a)(6)(ii) of this section are 

subject to annual renewal, but in no 

case may a CAH be granted such an 

exception for more than 5 years. 

* * * * * 

PART 495—STANDARDS FOR THE 

ELECTRONIC HEALTH RECORD 

TECHNOLOGY INCENTIVE PROGRAM 

■ 5. The authority citation for part 495 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh). 

Subpart A—General Provisions 

■ 6. Section 495.4 is amended as 

follows: 

■ A. Revising the definition of ‘‘EHR 

reporting period’’. 

■ B. Adding the definition of ‘‘EHR 

reporting period for a payment 

adjustment year’’ in alphabetical order. 

■ C. Revising the definition of 

‘‘Hospital-based EP’’. 

■ D. Revising paragraphs (1) and (3) of 

the definition of ‘‘Meaningful EHR 

user’’. 

■ E. Adding the definition of ‘‘Payment 

adjustment year’’ in alphabetical order. 

The revisions and additions read as 

follows: 

§ 495.4 Definitions. 

* * * * * 

EHR reporting period. Except with 

respect to payment adjustment years, 

EHR reporting period means either of 

the following: 

(1) For an eligible EP— 

(i) For the payment year in which the 

EP is first demonstrating he or she is a 

meaningful EHR user, any continuous 

90-day period within the calendar year; 

(ii) Except as specified in paragraphs 

(1)(iii) and (1)(iv) of this definition, for 

the subsequent payment years following 

the payment year in which the EP first 

successfully demonstrates he or she is a 

meaningful EHR user, the calendar year. 

(iii) For an EP seeking to demonstrate 

he or she is a meaningful EHR user for 

the Medicare EHR incentive program for 

CY 2014, any of the following 3-month 

periods: 

(A) January 1, 2014 through March 31, 

2014. 

(B) April 1, 2014 through June 30, 

2014. 

(C) July 1, 2014 through September 

30, 2014. 

(D) October 1, 2014 through December 

31, 2014. 

(iv) For an EP seeking to demonstrate 

he or she is a meaningful EHR user for 

the Medicaid EHR incentive program for 

CY 2014 any continuous 90-day period 

within CY 2014. 

(2) For an eligible hospital or CAH— 

(i) For the payment year in which the 

eligible hospital or CAH is first 

demonstrating it is a meaningful EHR 

user, any continuous 90-day period 

within the Federal fiscal year; 

(ii) Except as specified in paragraph 

(2)(iii) of this definition, for the 

subsequent payment years following the 

payment year in which the eligible 

hospital or CAH first successfully 

demonstrates it is a meaningful EHR 

user, the Federal fiscal year. 

(iii) For an eligible hospital or CAH 

seeking to demonstrate it is a 

meaningful EHR user for FY 2014, any 

of the following 3-month periods: 

(A) October 1, 2013 through December 

31, 2013. 

(B) January 1, 2014 through March 31, 

2014. 

(C) April 1, 2014 through June 30, 

2014. 

(D) July 1, 2014 through September 

30, 2014. 

EHR reporting period for a payment 

adjustment year. For a payment 

adjustment year, the EHR reporting 

period means the following: 

(1) For an EP— 

(i)(A) Except as provided in 

paragraphs (1)(i)(B), (ii), and (iii) of this 

definition, the calendar year that is 2 

years before the payment adjustment 

year. 

(B) The special EHR reporting period 

for CY 2014 (specified in paragraph 

(1)(iii) or (1)(iv) of this definition, as 

applicable) of the definition of ‘‘EHR 

Reporting Period’’ that occurs within 

the calendar year that is 2 years before 

the payment adjustment year and is 

only for EHR reporting periods in CY 

2014. 

(ii) If an EP is demonstrating he or she 

is a meaningful EHR user for the first 

time in the calendar year, that is 2 years 

before the payment adjustment year, 

then any continuous 90-day period 

within such (2 years prior) calendar 

year. 

(iii)(A) If in the calendar year that is 

2 years before the payment adjustment 

year and in all prior calendar years, the 

EP has not successfully demonstrated he 

or she is a meaningful EHR user, then 

any continuous 90-day period that both 

begins in the calendar year 1 year before 

the payment adjustment year and ends 

at least 3 months before the end of such 

prior year. 

(B) Under this exception, the provider 

must successfully register for and attest 

to meaningful use no later than the date 

October 1 of the year before the payment 

adjustment year. 

(2) For an eligible hospital— 

(i)(A) Except as provided in 

paragraphs (2)(i)(B), (ii), and (iii) of this 

definition, the Federal fiscal year that is 

2 years before the payment adjustment 

year. 

(B) The special EHR reporting period 

for FY 2014 (defined in paragraph 

(2)(iii) of the definition ‘‘EHR Reporting 

Period’’) that occurs within the fiscal 

year that is 2 years before the payment 

adjustment year and is only for EHR 

reporting periods in fiscal year 2014. 

(ii) If an eligible hospital is 

demonstrating it is a meaningful EHR 

user for the first time in the Federal 

fiscal year that is 2 years before the 

payment adjustment year, then any 

continuous 90-day period within such 

(2 years prior) Federal fiscal year. 

(iii)(A) If in the Federal fiscal year 

that is 2 years before the payment 

adjustment year and for all prior Federal 

fiscal years the eligible hospital has not 

successfully demonstrated it is a 

meaningful EHR user, then any 

continuous 90-day period that both 

begins in the Federal fiscal year that is 

1 year before the payment adjustment 

year and ends at least 3 months before 

the end of such prior Federal fiscal year. 

(B) Under this exception, the eligible 

hospital must successfully register for 

and attest to meaningful use no later 

than July 1 of the year before the 

payment adjustment year. 

(3) For a CAH— 

(i) Except as provided in paragraph 

(3)(ii) of this definition, the Federal 

fiscal year that is the payment 

adjustment year. 

(ii) If the CAH is demonstrating it is 

a meaningful EHR user for the first time 

in the payment adjustment year, any 

continuous 90-day period within the 

Federal fiscal year that is the payment 

adjustment year. 

* * * * * 

Hospital-based EP. Unless it meets the 

requirements of § 495.5 of this part, a 

hospital-based EP means an EP who 

furnishes 90 percent or more of his or 

her covered professional services in 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54149 

sites of service identified by the codes 

used in the HIPAA standard transaction 

as an inpatient hospital or emergency 

room setting in the year preceding the 

payment year, or in the case of a 

payment adjustment year, in either of 

the 2 years before such payment 

adjustment year. 

(1) For Medicare, this is calculated 

based on— 

(i) The FFY preceding the payment 

year; and 

(ii) For the payment adjustments, on 

the— 

(A) FFY preceding the payment 

adjustment year; or 

(B) FFY 2 years before the payment 

adjustment year. 

(2) For Medicaid, it is at the State’s 

discretion if the data is gathered on the 

Federal fiscal year or calendar year 

preceding the payment year. 

* * * * * 

Meaningful EHR user * * * 

(1) Subject to paragraph (3) of this 

definition, an EP, eligible hospital or 

CAH that, for an EHR reporting period 

for a payment year or payment 

adjustment year, demonstrates in 

accordance with § 495.8 meaningful use 

of Certified EHR Technology by meeting 

the applicable objectives and associated 

measures under § 495.6 and successfully 

reporting the clinical quality measures 

selected by CMS to CMS or the States, 

as applicable, in the form and manner 

specified by CMS or the States, as 

applicable; and 

* * * * * 

(3) To be considered a meaningful 

EHR user, at least 50 percent of an EP’s 

patient encounters during an EHR 

reporting period for a payment year (or, 

in the case of a payment adjustment 

year, during an applicable EHR 

reporting period for such payment 

adjustment year) must occur at a 

practice/location or practices/locations 

equipped with Certified EHR 

Technology. 

* * * * * 

Payment adjustment year means 

either of the following: 

(1) For an EP, a calendar year 

beginning with CY 2015. 

(2) For a CAH or an eligible hospital, 

a Federal fiscal year beginning with FY 

2015. 

* * * * * 

■ 7. Section 495.5 is added to read as 

follows: 

§ 495.5 Requirements for EPs seeking to 

reverse a hospital-based determination 

under § 495.4. 

(a) Exception for certain EPs. 

Beginning with payment year 2013, an 

EP who meets the definition of hospitalbased EP specified in § 495.4 but who 

can demonstrate to CMS that the EP 

funds the acquisition, implementation, 

and maintenance of Certified EHR 

Technology, including supporting 

hardware and interfaces needed for 

meaningful use without reimbursement 

from an eligible hospital or CAH, and 

uses such Certified EHR Technology in 

the inpatient or emergency department 

of a hospital (instead of the hospital’s 

Certified EHR Technology), may be 

determined by CMS to be a nonhospitalbased EP. 

(b) Process for determining a 

nonhospital-based EP. When an EP 

registers for a given payment year they 

should receive a determination of 

whether they have been determined 

‘‘hospital-based.’’ 

(1) An EP determined ‘‘hospitalbased,’’ but who wishes to be 

determined nonhospital-based as 

specified in paragraph (a) of section, 

may use an administrative process to 

provide documentation and seek a 

nonhospital-based determination. Such 

administrative process will be available 

throughout the incentive payment year 

and including the 2 months following 

the incentive payment year in which the 

EP may attest to being a meaningful 

EHR user. 

(2) If an EP is determined 

nonhospital-based under paragraph (a) 

of this section, to be considered 

nonhospital-based for subsequent 

payment years, the EP must attest in 

such payment year (or by the time the 

EP must attest it is a meaningful EHR 

user for such year) that the EP continues 

to meet the criteria of paragraph (a) of 

this section. 

(c) Requirements for nonhospitalbased EPs. An EP determined 

nonhospital-based must— 

(1) Continue to meet all applicable 

requirements to receive an incentive 

payment, including meeting all 

requirements for meaningful use; and 

(2) Demonstrate meaningful use using 

all encounters at all locations equipped 

with Certified EHR Technology, 

including those in the inpatient and 

emergency departments of the hospital. 

■ 8. Section 495.6 is amended as 

follows: 

■ A. Redesignating paragraph (a)(2)(ii) 

as paragraph (a)(2)(ii)(A). 

■ B. Adding paragraph (a)(2)(ii)(B). 

■ C. Redesignating paragraph (b)(2)(ii) 

as paragraph (b)(2)(ii)(A). 

■ D. Adding paragraph (b)(2)(ii)(B). 

■ E. In paragraphs (c) introductory text 

and (c)(1), the references ‘‘paragraphs 

(d) through (g)’’ are removed and the 

references ‘‘paragraphs (d) through (m)’’ 

is added in their place. 

■ F. Redesignating paragraph (d)(1)(ii) 

as paragraph (d)(1)(ii)(A). 

■ G. Adding paragraph (d)(1)(ii)(B). 

■ H. Redesignating paragraph (d)(4)(iii) 

as paragraph (d)(4)(iii)(A). 

■ I. Adding a paragraph (d)(4)(iii)(B). 

■ J. Redesignating paragraph (d)(8)(i)(E) 

as paragraph (d)(8)(i)(E)(1). 

■ K. Adding paragraphs (d)(8)(i)(E)(2) 

and (3). 

■ L. Redesignating paragraph (d)(8)(ii) 

as paragraph (d)(8)(ii)(A). 

■ M. Adding paragraphs (d)(8)(ii)(B) and 

(C). 

■ N. Redesignating paragraph (d)(8)(iii) 

as paragraph (d)(8)(iii)(A). 

■ O. Adding paragraphs (d)(8)(iii)(B) 

and (C). 

■ P. Redesignating paragraph (d)(10)(i) 

as paragraph (d)(10)(i)(A). 

■ Q. Adding paragraph (d)(10)(i)(B). 

■ R. Redesignating paragraph (d)(10)(ii) 

as paragraph (d)(10)(ii)(A). 

■ S. Adding a paragraph (d)(10)(ii)(B). 

■ T. Redesignating paragraph (d)(12)(i) 

as paragraph (d)(12)(i)(A). 

■ U. Adding a paragraph (d)(12)(i)(B). 

■ V. Redesignating paragraph (d)(12)(ii) 

as paragraph (d)(12)(ii)(A). 

■ W. Adding a paragraph (d)(12)(ii)(B). 

■ X. Redesignating paragraph (d)(12)(iii) 

as paragraph (d)(12)(iii)(A). 

■ Y. Adding a paragraph (d)(12)(iii)(B). 

■ Z. Redesignating paragraph (d)(14)(i) 

as paragraph (d)(14)(i)(A). 

■ AA. Adding a paragraph (d)(14)(i)(B). 

■ BB. Redesignating paragraph 

(d)(14)(ii) as paragraph (d)(14)(ii)(A). 

■ CC. Adding a paragraph (d)(14)(ii)(B). 

■ DD. In paragraph (e) introductory 

text— 

■ i. Removing the colon and adding a 

period in its place. 

■ ii. Adding a sentence at the end of the 

paragraph. 

■ EE. Redesignating paragraph (e)(5)(i) 

as paragraph (e)(5)(i)(A). 

■ FF. Adding a paragraph (e)(5)(i)(B). 

■ GG. Redesignating paragraph (e)(5)(ii) 

as paragraph (e)(5)(ii)(A). 

■ HH. Adding paragraph (e)(5)(ii)(B). 

■ II. Redesignating paragraph (e)(9)(i) as 

(e)(9)(i)(A). 

■ JJ. Adding paragraph (e)(9)(i)(B). 

■ KK. Redesignating paragraph (e)(10)(i) 

as (e)(10)(i)(A). 

■ LL. Adding paragraph (e)(10)(i)(B). 

■ MM. Redesignating paragraph (f)(1)(ii) 

as paragraph (f)(1)(ii)(A). 

■ NN. Adding paragraphs (f)(1)(ii)(B) 

and (C). 

■ OO. Redesignating paragraph 

(f)(7)(i)(E) as paragraph (f)(7)(i)(E)(1). 

■ PP. Adding a paragraphs (f)(7)(i)(E)(2) 

and (3). 

■ QQ. Redesignating paragraph (f)(7)(ii) 

as (f)(7)(ii)(A). 

■ RR. Adding paragraphs (f)(7)(ii)(B) 

and (C). 

mstockstill on DSK4VPTVN1PROD with RULES2

54150 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

■ SS. Redesignating paragraph (f)(9)(i) 

as paragraph (f)(9)(i)(A). 

■ TT. Adding a paragraph (f)(9)(i)(B). 

■ UU. Redesignating paragraph (f)(9)(ii) 

as paragraph (f)(9)(ii)(A). 

■ VV. Adding a paragraph (f)(9)(ii)(B). 

■ WW. Redesignating paragraphs 

(f)(11)(i) and (ii) as paragraphs 

(f)(11)(i)(A) and (ii)(A), respectively. 

■ XX. Adding paragraphs (f)(11)(i)(B) 

and (ii)(B). 

■ YY. Redesignating paragraph (f)(12)(i) 

as paragraph (f)(12)(i)(A). 

■ ZZ. Adding a paragraph (f)(12)(i)(B). 

■ AAA. Redesignating paragraph 

(f)(12)(ii) as paragraph (f)(12)(ii)(A). 

■ BBB. Adding a paragraph (f)(12)(ii)(B). 

■ CCC. Redesignating paragraph 

(f)(12)(iii) as paragraph (f)(12)(iii)(A). 

■ DDD. Adding a paragraph 

(f)(12)(iii)(B). 

■ EEE. Redesignating paragraph 

(f)(13)(i) as paragraph (f)(13)(i)(A). 

■ FFF. Adding a paragraph (f)(13)(i)(B). 

■ GGG. Redesignating paragraph 

(f)(13)(ii) as paragraph (f)(13)(ii)(A). 

■ HHH. Adding a paragraph 

(f)(13)(ii)(B). 

■ III. In paragraph (g) introductory 

text— 

■ i. Removing the colon and adding a 

period in its place. 

■ ii. Adding a sentence at the end of the 

paragraph. 

■ JJJ. Redesignating paragraph (g)(8)(i) 

as paragraph (g)(8)(i)(A). 

■ KKK. Adding a paragraph (g)(8)(i)(B). 

■ LLL. Redesignating paragraph (g)(9)(i) 

as paragraph (g)(9)(i)(A). 

■ MMM. Adding a paragraph 

(g)(9)(i)(B). 

■ NNN. Redesignating paragraph 

(g)(10)(i) as paragraph (g)(10)(i)(A). 

■ OOO. Adding a paragraph 

(g)(10)(i)(B). 

■ PPP. Revising paragraphs (h) and (i). 

■ QQQ. Adding new paragraphs (j) 

through (m). 

The additions and revisions read as 

follows: 

§ 495.6 Meaningful use objectives and 

measures for EPs, eligible hospitals, and 

CAHs. 

* * * * * 

(a) * * * 

(2) * * * 

(ii) * * * 

(B) Beginning 2014, an exclusion does 

not reduce (by the number of exclusions 

applicable) the number of objectives 

that would otherwise apply in 

paragraph (e) of this section unless five 

or more objectives can be excluded. An 

EP must meet five of the objectives and 

associated measures specified in 

paragraph (e) of this section, one of 

which must be either paragraph (e)(9) or 

(10) of this section, unless the EP has an 

exclusion from five or more objectives 

specified in paragraph (e) of this 

section, in which case the EP must meet 

all remaining objectives and associated 

measures in paragraph (e) of this 

section. 

* * * * * 

(b) * * * 

(2) * * * 

(ii) * * * 

(B) Beginning 2014, an exclusion does 

not reduce (by the number of exclusions 

applicable) the number of objectives 

that would otherwise apply in 

paragraph (g) of this section. Eligible 

hospitals or CAHs must meet five of the 

objectives and associated measures 

specified in paragraph (g) of this 

section, one which must be specified in 

paragraph (g)(8), (9), or (10) of this 

section. 

* * * * * 

(d) * * * 

(1) * * * 

(ii) * * * 

(B) Subject to paragraph (c) of this 

section, more than 30 percent of 

medication orders created by the EP 

during the EHR reporting period are 

recorded using computerized provider 

order entry, or the measure specified in 

paragraph (d)(1)(ii)(A) of this section. 

* * * * * 

(4) * * * 

(iii) * * * 

(B) Beginning 2013, any EP who does 

not have a pharmacy within their 

organization and there are no 

pharmacies that accept electronic 

prescriptions within 10 miles of the EP’s 

practice location at the start of his/her 

EHR reporting period, or the exclusion 

specified in (d)(4)(iii)(A) of this section. 

* * * * * 

(8)(i) * * * 

(E) * * * 

(2) For 2013, plot and display growth 

charts for patients 0–20 years, including 

body mass index, or paragraph 

(d)(8)(i)(E)(1) of this section. 

(3) Beginning 2014, plot and display 

growth charts for patients 0–20 years, 

including body mass index. 

(ii) * * * 

(B) For 2013—(1) Subject to paragraph 

(c) of this section, more than 50 percent 

of all unique patients seen by the EP 

during the EHR reporting period have 

blood pressure (for patients age 3 and 

over only) and height/length and weight 

(for all ages) recorded as structured data; 

or 

(2) The measure specified in 

paragraph (d)(8)(ii)(A) of this section. 

(C) Beginning 2014, only the measure 

specified in paragraph (d)(8)(ii)(B)(1) of 

this section. 

(iii) * * * 

(B) For 2013, either of the following: 

(1) The exclusion specified in 

paragraph (d)(8)(iii)(A) of this section. 

(2) The exclusion for an EP who— 

(i) Sees no patients 3 years or older is 

excluded from recording blood pressure; 

(ii) Believes that all three vital signs 

of height/length, weight, and blood 

pressure have no relevance to their 

scope of practice is excluded from 

recording them; 

(iii) Believes that height/length and 

weight are relevant to their scope of 

practice, but blood pressure is not, is 

excluded from recording blood pressure; 

or 

(iv) Believes that blood pressure is 

relevant to their scope of practice, but 

height/length and weight are not, is 

excluded from recording height/length 

and weight. 

(C) Beginning 2014, only the 

exclusion specified in paragraph 

(d)(8)(iii)(B)(2) of this section. 

* * * * * 

(10)(i) * * * 

(B) Beginning 2013, this objective is 

reflected in the definition of a 

meaningful EHR user in § 495.4 and is 

no longer listed as an objective in this 

paragraph (d). 

(ii) * * * 

(B) Beginning 2013, this measure is 

reflected in the definition of a 

meaningful EHR user in § 495.4 and no 

longer listed as a measure in this 

paragraph (d). 

* * * * * 

(12)(i) * * * 

(B) Beginning 2014, provide patients 

the ability to view online, download, 

and transmit their health information 

within 4 business days of the 

information being available to the EP. 

(ii) * * * 

(B) Beginning 2014, subject to 

paragraph (c) of this section, more than 

50 percent of all unique patients seen by 

the EP during the EHR reporting period 

are provided timely (available to the 

patient within 4 business days after the 

information is available to the EP) 

online access to their health information 

subject to the EP’s discretion to 

withhold certain information. 

(iii) * * * 

(B) Beginning 2014, any EP who 

neither orders nor creates any of the 

information listed for inclusion as part 

of this measure. 

* * * * * 

(14)(i) * * * 

(B) Beginning 2013, this objective is 

no longer required as part of the core 

set. 

(ii) * * * 

(B) Beginning 2013, this measure is no 

longer required as part of the core set. 

* * * * * 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54151 

(e) * * * Beginning 2014, an EP must 

meet five of the following objectives and 

associated measures, one of which must 

be either paragraph (e)(9) or (10) of this 

section unless the EP has an exclusion 

from five or more objectives in this 

paragraph (e), in which case the EP 

must meet all remaining objectives and 

associated measures in paragraph (e) of 

this section. 

* * * * * 

(5)(i) * * * 

(B) Beginning 2014, this objective is 

no longer included in the menu set. 

(ii) * * * 

(B) Beginning 2014, this measure is no 

longer included in the menu set. 

* * * * * 

(9)(i) * * * 

(B) Beginning 2013, capability to 

submit electronic data to immunization 

registries or immunization information 

systems and actual submission except 

where prohibited and according to 

applicable law and practice. 

* * * * * 

(10)(i) * * * 

(B) Beginning 2013, capability to 

submit electronic syndromic 

surveillance data to public health 

agencies and actual submission except 

where prohibited and according to 

applicable law and practice. 

* * * * * 

(f) * * * 

(1) * * * 

(ii) * * * 

(B) Subject to paragraph (c) of this 

section, more than 30 percent of 

medication orders created by the 

authorized providers of the eligible 

hospital or CAH for patients admitted to 

their inpatient or emergency 

departments (POS 21 or 23) during the 

EHR reporting period are recorded using 

computerized provider order entry, or 

the measure specified in paragraph 

(f)(1)(ii)(A) of this section. 

* * * * * 

(7) * * * 

(i) * * * 

(E) * * * 

(2) For 2013, plot and display growth 

charts for patients 0–20 years, including 

body mass index, or paragraph 

(f)(7)(i)(E)(1) of this section. 

(3) Beginning 2014, plot and display 

growth charts for patients 0–20 years, 

including body mass index. 

(ii) * * * 

(B) For 2013—(1) Subject to paragraph 

(c) of this section, more than 50 percent 

of all unique patients admitted to the 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period have 

blood pressure (for patients age 3 and 

over only) and height/length and weight 

(for all ages) recorded as structured data; 

or 

(2) The measure specified in 

paragraph (f)(7)(ii)(A) of this section. 

(C) Beginning 2014, only the measure 

specified in paragraph (f)(7)(ii)(B)(1) of 

this section. 

* * * * * 

(9) * * * 

(i) * * * 

(B) Beginning 2013, this objective is 

reflected in the definition of a 

meaningful EHR user in § 495.4 and no 

longer listed as an objective in this 

paragraph (f). 

(ii) * * * 

(B) Beginning 2013, this measure is 

reflected in the definition of a 

meaningful EHR user in § 495.4 and no 

longer listed as a measure in this 

paragraph (f). 

* * * * * 

(11) * * * 

(i) * * * 

(B) Beginning 2014, this objective is 

no longer required as part of the core 

set. 

(ii) * * * 

(B) Beginning 2014, this measure is no 

longer required as part of the core set. 

(12) * * * 

(i) * * * 

(B) Beginning 2014, provide patients 

the ability to view online, download, 

and transmit information about a 

hospital admission. 

(ii) * * * 

(B) Beginning 2014, subject to 

paragraph (c) of this section, more than 

50 percent of all patients who are 

discharged from the inpatient or 

emergency department (POS 21 or 23) of 

an eligible hospital or CAH have their 

information available online within 36 

hours of discharge. 

(iii) * * * 

(B) Beginning 2014, this exclusion is 

no longer available. 

* * * * * 

(13) * * * 

(i) * * * 

(B) Beginning 2013, this objective is 

no longer required as part of the core 

set. 

(ii) * * * 

(B) Beginning 2013, this measure is no 

longer required as part of the core set. 

* * * * * 

(g) * * * Beginning 2014, eligible 

hospitals or CAHs must meet five of the 

following objectives and associated 

measures, one which must be specified 

in paragraph (g)(8), (9), or (10) of this 

section: 

* * * * * 

(8)(i) * * * 

(B) Beginning 2013, Capability to 

submit electronic data to immunization 

registries or immunization information 

systems and actual submission except 

where prohibited and according to 

applicable law and practice. 

(9)(i) * * * 

(B) Beginning 2013, capability to 

submit electronic data on reportable (as 

required by State or local law) lab 

results to public health agencies and 

actual submission except where 

prohibited according to applicable law 

and practice. 

(10)(i) * * * 

(B) Beginning 2013, capability to 

submit electronic syndromic 

surveillance data to public health 

agencies and actual submission except 

where prohibited and according to 

applicable law and practice. 

* * * * * 

(h) Stage 2 criteria for EPs–(1) General 

rule regarding Stage 2 criteria for 

meaningful use for EPs. Except as 

specified in paragraph (h)(2) of this 

section, EPs must meet all objectives 

and associated measures of the Stage 2 

criteria specified in paragraph (j) of this 

section and 3 objectives of the EP’s 

choice from paragraph (k) of this section 

to meet the definition of a meaningful 

EHR user. 

(2) Exclusion for nonapplicable 

objectives. (i) An EP may exclude a 

particular objective contained in 

paragraph (j) or (k) of this section, if the 

EP meets all of the following 

requirements: 

(A) Must ensure that the objective in 

paragraph (j) or (k) of this section 

includes an option for the EP to attest 

that the objective is not applicable. 

(B) Meets the criteria in the applicable 

objective that would permit the 

attestation. 

(C) Attests. 

(ii)(A) An exclusion will reduce (by 

the number of exclusions applicable) 

the number of objectives that would 

otherwise apply in paragraph (j) of this 

section. For example, an EP that has an 

exclusion from one of the objectives in 

paragraph (j) of this section must meet 

16 objectives from such paragraph to 

meet the definition of a meaningful EHR 

user. 

(B) An exclusion does not reduce (by 

the number of exclusions applicable) 

the number of objectives that would 

otherwise apply in paragraph (k) of this 

section unless four or more exclusions 

apply. For example, an EP that has an 

exclusion for one of the objectives in 

paragraph (k) of this section must meet 

three of the five nonexcluded objectives 

from such paragraph to meet the 

definition of a meaningful EHR user. If 

an EP has an exclusion for four of the 

objectives in paragraph (k) of this 

mstockstill on DSK4VPTVN1PROD with RULES2

54152 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

section, then he or she must meet the 

remaining two nonexcluded objectives 

from such paragraph to meet the 

definition of a meaningful EHR user. 

(i) Stage 2 criteria for eligible 

hospitals and CAHs–(1) General rule 

regarding Stage 2 criteria for meaningful 

use for eligible hospitals or CAHs. 

Except as specified in paragraph (i)(2) of 

this section, eligible hospitals and CAHs 

must meet all objectives and associated 

measures of the Stage 2 criteria 

specified in paragraph (l) of this section 

and three objectives of the eligible 

hospital’s or CAH’s choice from 

paragraph (m) of this section to meet the 

definition of a meaningful EHR user. 

(2) Exclusions for nonapplicable 

objectives. (i) An eligible hospital or 

CAH may exclude a particular objective 

that includes an option for exclusion 

contained in paragraphs (l) or (m) of this 

section, if the hospital meets all of the 

following requirements: 

(A) The hospital meets the criteria in 

the applicable objective that would 

permit an exclusion. 

(B) The hospital so attests. 

(ii)(A) An exclusion will reduce (by 

the number of exclusions applicable) 

the number of objectives that would 

otherwise apply in paragraph (l) of this 

section. For example, an eligible 

hospital that has an exclusion from 1 of 

the objectives in paragraph (l) of this 

section must meet 15 objectives from 

such paragraph to meet the definition of 

a meaningful EHR user. 

(B) An exclusion does not reduce (by 

the number of exclusions applicable) 

the number of objectives that would 

otherwise apply in paragraph (m) of this 

section. For example, an eligible 

hospital that has an exclusion for one of 

the objectives in paragraph (m) of this 

section must meet three of the five 

nonexcluded objectives from such 

paragraph to meet the definition of a 

meaningful EHR user. 

(j) Stage 2 core criteria for EPs. An EP 

must satisfy the following objectives 

and associated measures, except those 

objectives and associated measures for 

which an EP qualifies for an exclusion 

under paragraph (h)(2) of this section 

specified in this paragraph (j). 

(1)(i) Objective. Use computerized 

provider order entry for medication, 

laboratory, and radiology orders directly 

entered by any licensed healthcare 

professional who can enter orders into 

the medical record per State, local, and 

professional guidelines. 

(ii) Measures. Subject to paragraph (c) 

of this section— 

(A) More than 60 percent of 

medication orders created by the EP 

during the EHR reporting period are 

recorded using computerized provider 

order entry; 

(B) More than 30 percent of laboratory 

orders created by the EP during the EHR 

reporting period are recorded using 

computerized provider order entry; and 

(C) More than 30 percent of radiology 

orders created by the EP during the EHR 

reporting period are recorded using 

computerized provider order entry. 

(iii) Exclusions in accordance with 

paragraph (h)(2) of this section. (A) For 

the measure specified in paragraph 

(j)(1)(ii)(A) of this section, any EP who 

writes fewer than 100 medication orders 

during the EHR reporting period. 

(B) For the measure specified in 

paragraph (j)(1)(ii)(B) of this section, any 

EP who writes fewer than 100 laboratory 

orders during the EHR reporting period. 

(C) For the measure specified in 

paragraph (j)(1)(ii)(C), any EP who 

writes fewer than 100 radiology orders 

during the EHR reporting period. 

(2)(i) Objective. Generate and transmit 

permissible prescriptions electronically 

(eRx). 

(ii) Measure. Subject to paragraph (c) 

of this section, more than 50 percent of 

all permissible prescriptions, or all 

prescriptions, written by the EP are 

queried for a drug formulary and 

transmitted electronically using 

Certified EHR Technology. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who— 

(A) Writes fewer than 100 permissible 

prescriptions during the EHR reporting 

period; or (B) Does not have a pharmacy 

within their organization and there are 

no pharmacies that accept electronic 

prescriptions within 10 miles of the EP’s 

practice location at the start of his or her 

EHR reporting period. 

(3)(i) Objective. Record all of the 

following demographics: 

(A) Preferred language. 

(B) Sex. 

(C) Race. 

(D) Ethnicity. 

(E) Date of birth. 

(ii) Measure. More than 80 percent of 

all unique patients seen by the EP 

during the EHR reporting period have 

demographics recorded as structured 

data. 

(4)(i) Objective. Record and chart 

changes in the following vital signs: 

(A) Height/Length. 

(B) Weight. 

(C) Blood pressure (ages 3 and over). 

(D) Calculate and display body mass 

index (BMI). 

(E) Plot and display growth charts for 

patients 0–20 years, including body 

mass index. 

(ii) Measure. Subject to paragraph (c) 

of this section, more than 80 percent of 

all unique patients seen by the EP 

during the EHR reporting period have 

blood pressure (for patients age 3 and 

over only) and height/length and weight 

(for all ages) recorded as structured data. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who— 

(A) Sees no patients 3 years or older 

is excluded from recording blood 

pressure; 

(B) Believes that all three vital signs 

of height/length, weight, and blood 

pressure have no relevance to their 

scope of practice is excluded from 

recording them; 

(C) Believes that height/length and 

weight are relevant to their scope of 

practice, but blood pressure is not, is 

excluded from recording blood pressure; 

or 

(D) Believes that blood pressure is 

relevant to their scope of practice, but 

height/length and weight are not, is 

excluded from recording height/length 

and weight. 

(5)(i) Objective. Record smoking status 

for patients 13 years old or older. 

(ii) Measure. Subject to paragraph (c) 

of this section, more than 80 percent of 

all unique patients 13 years old or older 

seen by the EP during the EHR reporting 

period have smoking status recorded as 

structured data. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who sees no patients 13 years old or 

older. 

(6)(i) Objective. Use clinical decision 

support to improve performance on high 

priority health conditions. 

(ii) Measures. (A) Implement five 

clinical decision support interventions 

related to four or more clinical quality 

measures at a relevant point in patient 

care for the entire EHR reporting period. 

Absent four clinical quality measures 

related to an EP’s scope of practice or 

patient population, the clinical decision 

support interventions must be related to 

high-priority health conditions; and 

(B) The EP has enabled and 

implemented the functionality for drugdrug and drug-allergy interaction checks 

for the entire EHR reporting period. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section for 

paragraph (j)(6)(ii)(B) of this section. An 

EP who writes fewer than 100 

medication orders during the EHR 

reporting period. 

(7)(i) Objective. Incorporate clinical 

lab test results into Certified EHR 

Technology as structured data. 

(ii) Measure. Subject to paragraph (c) 

of this section, more than 55 percent of 

all clinical lab tests results ordered by 

the EP during the EHR reporting period 

whose results are either in a positive/ 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54153 

negative affirmation or numerical format 

are incorporated in Certified EHR 

Technology as structured data. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who orders no lab tests whose results 

are either in a positive/negative 

affirmation or numerical format during 

the EHR reporting period. 

(8)(i) Objective. Generate lists of 

patients by specific conditions to use for 

quality improvement, reduction of 

disparities, research, or outreach. 

(ii) Measure. Generate at least one 

report listing patients of the EP with a 

specific condition. 

(9)(i) Objective. Use clinically relevant 

information to identify patients who 

should receive reminders for 

preventive/follow-up care and send 

these patients the reminder, per patient 

preference. 

(ii) Measure. Subject to paragraph (c) 

of this section, more than 10 percent of 

all unique patients who have had two or 

more office visits with the EP within the 

24 months before the beginning of the 

EHR reporting period were sent a 

reminder, per patient preference when 

available. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who has had no office visits in the 24 

months before the beginning of the EHR 

reporting period. 

(10)(i) Objective. Provide patients the 

ability to view online, download, and 

transmit their health information within 

4 business days of the information being 

available to the EP. 

(ii) Measures. (A) More than 50 

percent of all unique patients seen by 

the EP during the EHR reporting period 

are provided timely (available to the 

patient within 4 business days after the 

information is available to the EP) 

online access to their health information 

subject to the EP’s discretion to 

withhold certain information; and 

(B) More than 5 percent of all unique 

patients seen by the EP during the EHR 

reporting period (or their authorized 

representatives) view, download or 

transmit to a third party their health 

information. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who— 

(A) Neither orders nor creates any of 

the information listed for inclusion as 

part of the measures in paragraphs 

(j)(10)(ii)(A) and (B) of this section, 

except for ‘‘Patient name’’ and 

‘‘Provider’s name and office contact 

information,’’ is excluded from both 

paragraphs (j)(10)(ii)(A) and (B) of this 

section; or 

(B) Conducts 50 percent or more of 

his or her patient encounters in a county 

that does not have 50 percent or more 

of its housing units with 3Mbps 

broadband availability according to the 

latest information available from the 

FCC on the first day of the EHR 

reporting period is excluded from 

paragraph (j)(10)(ii)(B) of this section. 

(11)(i) Objective. Provide clinical 

summaries for patients for each office 

visit. 

(ii) Measure. Subject to paragraph (c) 

of this section, clinical summaries 

provided to patients or patientauthorized representatives within 1 

business day for more than 50 percent 

of office visits. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who has no office visits during the EHR 

reporting period. 

(12)(i) Objective. Use clinically 

relevant information from Certified EHR 

Technology to identify patient-specific 

education resources and provide those 

resources to the patient. 

(ii) Measure. Patient-specific 

education resources identified by 

Certified EHR Technology are provided 

to patients for more than 10 percent of 

all unique patients with office visits 

seen by the EP during the EHR reporting 

period. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who has no office visits during the EHR 

reporting period. 

(13)(i) Objective. The EP who receives 

a patient from another setting of care or 

provider of care or believes an 

encounter is relevant should perform 

medication reconciliation. 

(ii) Measure. Subject to paragraph (c) 

of this section, the EP performs 

medication reconciliation for more than 

50 percent of transitions of care in 

which the patient is transitioned into 

the care of the EP. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who was not the recipient of any 

transitions of care during the EHR 

reporting period. 

(14)(i) Objective. The EP who 

transitions their patient to another 

setting of care or provider of care or 

refers their patient to another provider 

of care provides a summary care record 

for each transition of care or referral. 

(ii) Measures. (A) Subject to paragraph 

(c) of this section, the EP that transitions 

or refers their patient to another setting 

of care or provider of care provides a 

summary of care record for more than 

50 percent of transitions of care and 

referrals; 

(B) Subject to paragraph (c) of this 

section, the EP that transitions or refers 

their patient to another setting of care or 

provider of care provides a summary of 

care record for more than 10 percent of 

such transitions and referrals either— 

(1) Electronically transmitted using 

Certified EHR Technology to a recipient; 

or 

(2) Where the recipient receives the 

summary of care record via exchange 

facilitated by an organization that is a 

NwHIN Exchange participant or in a 

manner that is consistent with the 

governance mechanism ONC establishes 

for the nationwide health information 

network, and 

(C) Subject to paragraph (c) of this 

section an EP must satisfy one of the 

following: 

(1) Conducts one or more successful 

electronic exchanges of a summary of 

care record meeting the measure 

specified in paragraph (j)(14)(ii)(B) of 

this section with a recipient using 

technology to receive the summary of 

care record that was designed by a 

different EHR developer than the 

sender’s EHR technology certified at 45 

CFR 107.314(b)(2); or 

(2) Conducts one or more successful 

tests with the CMS designated test EHR 

during the EHR reporting period. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who transfers a patient to another 

setting or refers a patient to another 

provider less than 100 times during the 

EHR reporting period. 

(15)(i) Objective. Capability to submit 

electronic data to immunization 

registries or immunization information 

systems except where prohibited, and in 

accordance with applicable law and 

practice. 

(ii) Measure. Successful ongoing 

submission of electronic immunization 

data from Certified EHR Technology to 

an immunization registry or 

immunization information system for 

the entire EHR reporting period. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

that meets one or more of the following 

criteria: 

(A) Does not administer any of the 

immunizations to any of the 

populations for which data is collected 

by their jurisdiction’s immunization 

registry or immunization information 

system during the EHR reporting period. 

(B) Operates in a jurisdiction for 

which no immunization registry or 

immunization information system is 

capable of accepting the specific 

standards required for Certified EHR 

Technology at the start of his or her EHR 

reporting period. 

(C) Operates in a jurisdiction where 

no immunization registry or 

immunization information system 

provides information timely on 

capability to receive immunization data. 

mstockstill on DSK4VPTVN1PROD with RULES2

54154 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

(D) Operates in a jurisdiction for 

which no immunization registry or 

immunization information system that 

is capable of accepting the specific 

standards required by Certified EHR 

Technology at the start of his or her EHR 

reporting period can enroll additional 

EPs. 

(16)(i) Objective. Protect electronic 

health information created or 

maintained by the Certified EHR 

Technology through the implementation 

of appropriate technical capabilities. 

(ii) Measure. Conduct or review a 

security risk analysis in accordance 

with the requirements under 45 CFR 

164.308(a)(1), including addressing the 

encryption/security of data stored in 

Certified EHR Technology in accordance 

with requirements under 45 CFR 

164.312(a)(2)(iv) and 45 CFR 

164.306(d)(3), and implement security 

updates as necessary and correct 

identified security deficiencies as part 

of the EP’s risk management process. 

(17)(i) Objective. Use secure electronic 

messaging to communicate with 

patients on relevant health information. 

(ii) Measure. A secure message was 

sent using the electronic messaging 

function of Certified EHR Technology 

by more than 5 percent of unique 

patients (or their authorized 

representatives) seen by the EP during 

the EHR reporting period. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who meets one or more of the following 

criteria: 

(A) Has no office visits during the 

EHR reporting period. 

(B) Who conducts 50 percent or more 

of his or her patient encounters in a 

county that does not have 50 percent or 

more of its housing units with 3Mbps 

broadband availability according to the 

latest information available from the 

FCC on the first day of their EHR 

reporting period. 

(k) Stage 2 menu set criteria for EPs. 

An EP must meet 3 of the following 

objectives and associated measures, 

unless the EP has an exclusion from 4 

or more objectives in this paragraph (k) 

of this section, in which case the EP 

must meet all remaining objectives and 

associated measures. 

(1)(i) Objective. Imaging results 

consisting of the image itself and any 

explanation or other accompanying 

information are accessible through 

Certified EHR Technology. 

(ii) Measure. Subject to paragraph (c) 

of this section, more than 10 percent of 

all tests whose result is one or more 

images ordered by the EP during the 

EHR reporting period are accessible 

through Certified EHR Technology. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who meets one or more of the following 

criteria. 

(A) Orders less than 100 tests whose 

result is an image during the EHR 

reporting period. 

(B) Has no access to electronic 

imaging results at the start of the EHR 

reporting period. 

(2)(i) Objective. Record patient family 

health history as structured data. 

(ii) Measure. More than 20 percent of 

all unique patients seen by the EP 

during the EHR reporting period have a 

structured data entry for one or more 

first-degree relatives. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who has no office visits during the EHR 

reporting period. 

(3)(i) Objective. Capability to submit 

electronic syndromic surveillance data 

to public health agencies, except where 

prohibited, and in accordance with 

applicable law and practice. 

(ii) Measure. Successful ongoing 

submission of electronic syndromic 

surveillance data from Certified EHR 

Technology to a public health agency 

for the entire EHR reporting period. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

that meets one or more of the following 

criteria: 

(A) Is not in a category of providers 

who collect ambulatory syndromic 

surveillance information on their 

patients during the EHR reporting 

period. 

(B) Operates in a jurisdiction for 

which no public health agency is 

capable of receiving electronic 

syndromic surveillance data in the 

specific standards required for Certified 

EHR Technology at the start of their 

EHR reporting period. 

(C) Operates in a jurisdiction where 

no public health agency provides 

information timely on capability to 

receive syndromic surveillance data. 

(D) Operates in a jurisdiction for 

which no public health agency that is 

capable of accepting the specific 

standards required by Certified EHR 

Technology at the start of their EHR 

reporting period can enroll additional 

EPs. 

(4)(i) Objective. Capability to identify 

and report cancer cases to a public 

health central cancer registry, except 

where prohibited, and in accordance 

with applicable law and practice. 

(ii) Measure. Successful ongoing 

submission of cancer case information 

from Certified EHR Technology to a 

public health central cancer registry for 

the entire EHR reporting period. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who meets one or more of the 

following— 

(A) Does not diagnose or directly treat 

cancer. 

(B) Operates in a jurisdiction for 

which no public health agency is 

capable of receiving electronic cancer 

case information in the specific 

standards required for Certified EHR 

Technology at the start of their EHR 

reporting period. 

(C) Operates in a jurisdiction where 

no public health agency provides 

information timely on capability to 

receive electronic cancer case 

information. 

(D) Operates in a jurisdiction for 

which no public health agency that is 

capable of receiving electronic cancer 

case information in the specific 

standards required for Certified EHR 

Technology at the beginning of their 

EHR reporting period can enroll 

additional EPs. 

(5)(i) Objective. Capability to identify 

and report specific cases to a specialized 

registry (other than a cancer registry), 

except where prohibited, and in 

accordance with applicable law and 

practice. 

(ii) Measure. Successful ongoing 

submission of specific case information 

from Certified EHR Technology to a 

specialized registry for the entire EHR 

reporting period. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who meets one or more of the following 

criteria: 

(A) Does not diagnose or directly treat 

any disease associated with a 

specialized registry sponsored by a 

national specialty society for which the 

EP is eligible, or the public health 

agencies in their jurisdiction; 

(B) Operates in a jurisdiction for 

which no specialized registry sponsored 

by a public health agency or by a 

national specialty society for which the 

EP is eligible is capable of receiving 

electronic specific case information in 

the specific standards required by 

Certified EHR Technology at the 

beginning of their EHR reporting period; 

(C) Operates in a jurisdiction where 

no public health agency or national 

specialty society for which the EP is 

eligible provides information timely on 

capability to receive information into 

their specialized registries; or 

(D) Operates in a jurisdiction for 

which no specialized registry sponsored 

by a public health agency or by a 

national specialty society for which the 

EP is eligible that is capable of receiving 

electronic specific case information in 

the specific standards required by 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54155 

Certified EHR Technology at the 

beginning of his or her EHR reporting 

period can enroll additional EPs. 

(6)(i) Objective. Record electronic 

notes in patient records. 

(ii) Measure. Enter at least one 

electronic progress note created, edited, 

and signed by an EP for more than 30 

percent of unique patients with at least 

one office visit during the EHR reporting 

period. The text of the electronic note 

must be text-searchable and may 

contain drawings and other content. 

(l) Stage 2 core criteria for eligible 

hospitals or CAHs. An eligible hospital 

or CAH must meet the following 

objectives and associated measures 

except those objectives and associated 

measures for which an eligible hospital 

or CAH qualifies for an exclusion under 

paragraph (i)(2) of this section. 

(1)(i) Objective. Use computerized 

provider order entry for medication, 

laboratory, and radiology orders directly 

entered by any licensed healthcare 

professional who can enter orders into 

the medical record per State, local, and 

professional guidelines. 

(ii) Measures. Subject to paragraph (c) 

of this section, more than— 

(A) Sixty percent of medication orders 

created by authorized providers of the 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period are 

recorded using computerized provider 

order entry, 

(B) Thirty percent of laboratory orders 

created by authorized providers of the 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period are 

recorded using computerized provider 

order entry, and 

(C) Thirty percent of radiology orders 

created by authorized providers of the 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period are 

recorded using computerized provider 

order entry. 

(2)(i) Objective. Record all of the 

following demographics: 

(A) Preferred language. 

(B) Sex. 

(C) Race. 

(D) Ethnicity. 

(E) Date of birth. 

(F) Date and preliminary cause of 

death in the event of mortality in the 

eligible hospital or CAH. 

(ii) Measure. More than 80 percent of 

all unique patients admitted to the 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period have 

demographics recorded as structured 

data. 

(3)(i) Objective. Record and chart 

changes in the following vital signs: 

(A) Height/Length. 

(B) Weight. 

(C) Blood pressure (ages 3 and over). 

(D) Calculate and display body mass 

index (BMI). 

(E) Plot and display growth charts for 

patients 0–20 years, including body 

mass index. 

(ii) Measure. Subject to paragraph (c) 

of this section, more than 80 percent of 

all unique patients admitted to the 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period have 

blood pressure (for patients age 3 and 

over only) and height/length and weight 

(for all ages) recorded as structured data. 

(4)(i) Objective. Record smoking status 

for patients 13 years old or older. 

(ii) Measure. Subject to paragraph (c) 

of this section, more than 80 percent of 

all unique patients 13 years old or older 

admitted to the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period have smoking 

status recorded as structured data. 

(iii) Exclusion in accordance with 

paragraph (i)(2) of this section. Any 

eligible hospital or CAH that admits no 

patients 13 years old or older to their 

inpatient or emergency department 

(POS 21 or 23) during the EHR reporting 

period. 

(5)(i) Objective. Use clinical decision 

support to improve performance on high 

priority health conditions. 

(ii) Measures. (A) Implement five 

clinical decision support interventions 

related to four or more clinical quality 

measures at a relevant point in patient 

care for the entire EHR reporting period. 

Absent four clinical quality measures 

related to an eligible hospital or CAH’s 

patient population, the clinical decision 

support interventions must be related to 

high-priority health conditions; and 

(B) The eligible hospital or CAH has 

enabled and implemented the 

functionality for drug-drug and drugallergy interaction checks for the entire 

EHR reporting period. 

(6)(i) Objective. Incorporate clinical 

lab test results into Certified EHR 

Technology as structured data. 

(ii) Measure. More than 55 percent of 

all clinical lab tests results ordered by 

authorized providers of the eligible 

hospital or CAH for patients admitted to 

its inpatient or emergency department 

(POS 21 or 23) during the EHR reporting 

period whose results are either in a 

positive/negative affirmation or 

numerical format are incorporated in 

Certified EHR Technology as structured 

data. 

(7)(i) Objective. Generate lists of 

patients by specific conditions to use for 

quality improvement, reduction of 

disparities, research or outreach. 

(ii) Measure. Generate at least one 

report listing patients of the eligible 

hospital or CAH with a specific 

condition. 

(8)(i) Objective. Provide patients the 

ability to view online, download, and 

transmit information about a hospital 

admission. 

(ii) Measures. (A) More than 50 

percent of all patients who are 

discharged from the inpatient or 

emergency department (POS 21 or 23) of 

an eligible hospital or CAH have their 

information available online within 36 

hours of discharge; and 

(B) More than 5 percent of all patients 

who are discharged from the inpatient 

or emergency department (POS 21 or 23) 

of an eligible hospital or CAH (or their 

authorized representative) view, 

download or transmit to a third party 

their information during the EHR 

reporting period. 

(iii) Exclusion in accordance with 

paragraph (i)(2) of this section. Any 

eligible hospital or CAH that is located 

in a county that does not have 50 

percent or more of its housing units 

with 3Mbps broadband availability 

according to the latest information 

available from the FCC on the first day 

of the EHR reporting period is excluded 

from paragraph (l)(8)(ii)(B) of this 

section. 

(9)(i) Objective. Use clinically relevant 

information from Certified EHR 

Technology to identify patient-specific 

education resources and provide those 

resources to the patient. 

(ii) Measure. More than 10 percent of 

all unique patients admitted to the 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

are provided patient-specific education 

resources identified by Certified EHR 

Technology. 

(10)(i) Objective. The eligible hospital 

or CAH that receives a patient from 

another setting of care or provider of 

care or believes an encounter is relevant 

should perform medication 

reconciliation. 

(ii) Measure. Subject to paragraph (c) 

of this section, the eligible hospital or 

CAH performs medication 

reconciliation for more than 50 percent 

of transitions of care in which the 

patient is admitted to the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23). 

(11)(i) Objective. The eligible hospital 

or CAH that transitions their patient to 

another setting of care or provider of 

care or refers their patient to another 

provider of care provides a summary 

care record for each transition of care or 

referral. 

mstockstill on DSK4VPTVN1PROD with RULES2

54156 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

(ii) Measures. (A) Subject to paragraph 

(c) in this section, the eligible hospital 

or CAH that transitions or refers their 

patient to another setting of care or 

provider of care provides a summary of 

care record for more than 50 percent of 

transitions of care and referrals, 

(B) Subject to paragraph (c) in this 

section, the eligible hospital or CAH 

that transitions their patient to another 

setting of care or provider of care 

provides a summary of care record for 

more than 10 percent of such transitions 

and referrals either— 

(1) Electronically transmitted using 

Certified EHR Technology to a recipient; 

or 

(2) Where the recipient receives the 

summary of care record via exchange 

facilitated by an organization that is a 

NwHIN Exchange participant or in a 

manner that is consistent with the 

governance mechanism ONC establishes 

for the nationwide health information 

network; and 

(C) Subject to paragraph (c) of this 

section an eligible hospital or CAH must 

satisfy one of the following: 

(1) Conducts one or more successful 

electronic exchanges of a summary of 

care record meeting the measure 

specified in paragraph (l)(11)(ii)(B) of 

this section with a recipient using 

technology to receive the summary of 

care record that was designed by a 

different EHR developer than the 

sender’s EHR technology certified at 45 

CFR 107.314(b)(2); or 

(2) Conducts one or more successful 

tests with the CMS designated test EHR 

during the EHR reporting period. 

(12)(i) Objective. Capability to submit 

electronic data to immunization 

registries or immunization information 

systems except where prohibited, and in 

accordance with applicable law and 

practice. 

(ii) Measure. Successful ongoing 

submission of electronic immunization 

data from Certified EHR Technology to 

an immunization registry or 

immunization information system for 

the entire EHR reporting period. 

(iii) Exclusion in accordance with 

paragraph (i)(2) of this section. Any 

eligible hospital or CAH that meets one 

or more of the following criteria: 

(A) The eligible hospital or CAH does 

not administer any of the 

immunizations to any of the 

populations for which data is collected 

by their jurisdiction’s immunization 

registry or immunization information 

system during the EHR reporting period. 

(B) The eligible hospital or CAH 

operates in a jurisdiction for which no 

immunization registry or immunization 

information system is capable of 

accepting the specific standards 

required for Certified EHR Technology 

at the start of their EHR reporting 

period. 

(C) The eligible hospital or CAH 

operates in a jurisdiction where no 

immunization registry or immunization 

information system provides 

information timely on capability to 

receive immunization data. 

(D) Operates in a jurisdiction for 

which no immunization registry or 

immunization information system that 

is capable of accepting the specific 

standards required by Certified EHR 

Technology at the start of their EHR 

reporting period can enroll additional 

eligible hospitals or CAHs. 

(13)(i) Objective. Capability to submit 

electronic reportable laboratory results 

to public health agencies, where except 

where prohibited, and in accordance 

with applicable law and practice. 

(ii) Measure. Successful ongoing 

submission of electronic reportable 

laboratory results from Certified EHR 

Technology to a public health agency 

for the entire EHR reporting period. 

(iii) Exclusion in accordance with 

paragraph (i)(2) of this section. Any 

eligible hospital or CAH that meets one 

or more of the following criteria: 

(A) Operates in a jurisdiction for 

which no public health agency is 

capable of receiving electronic 

reportable laboratory results in the 

specific standards required for Certified 

EHR Technology at the start of their 

EHR reporting period. 

(B) Operates in a jurisdiction for 

which no public health agency provides 

information timely on capability to 

receive electronic reportable laboratory 

results. 

(C) Operates in a jurisdiction for 

which no public health agency that is 

capable of accepting the specific 

standards required by Certified EHR 

Technology at the start of their EHR 

reporting period can enroll additional 

eligible hospitals or CAHs. 

(14)(i) Objective. Capability to submit 

electronic syndromic surveillance data 

to public health agencies, except where 

prohibited, and in accordance with 

applicable law and practice. 

(ii) Measure. Successful ongoing 

submission of electronic syndromic 

surveillance data from Certified EHR 

Technology to a public health agency 

for the entire EHR reporting period. 

(iii) Exclusion in accordance with 

paragraph (i)(2) of this section. Any 

eligible hospital or CAH that meets one 

or more of the following criteria: 

(A) Does not have an emergency or 

urgent care department. 

(B) Operates in a jurisdiction for 

which no public health agency is 

capable of receiving electronic 

syndromic surveillance data in the 

specific standards required for Certified 

EHR Technology at the start of their 

EHR reporting period or can enroll 

additional eligible hospitals or CAHs. 

(C) Operates in a jurisdiction for 

which no public health agency provides 

information timely on capability to 

receive syndromic surveillance data. 

(D) Operates in a jurisdiction for 

which no public health agency that is 

capable of accepting the specific 

standards required by Certified EHR 

Technology at the start of their EHR 

reporting period can enroll additional 

eligible hospitals or CAHs. 

(15)(i) Objective. Protect electronic 

health information created or 

maintained by the Certified EHR 

Technology through the implementation 

of appropriate technical capabilities. 

(ii) Measure. Conduct or review a 

security risk analysis in accordance 

with the requirements under 45 CFR 

164.308(a)(1), including addressing the 

encryption/security of data stored in 

Certified EHR Technology in accordance 

with requirements under 45 CFR 

164.312(a)(2)(iv) and 45 CFR 

164.306(d)(3), and implement security 

updates as necessary and correct 

identified security deficiencies as part 

of the eligible hospital’s or CAH’s risk 

management process. 

(16)(i) Objective. Automatically track 

medications from order to 

administration using assistive 

technologies in conjunction with an 

electronic medication administration 

record (eMAR). 

(ii) Measure. Subject to paragraph (c) 

of this section, more than 10 percent of 

medication orders created by authorized 

providers of the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period for which all 

doses are tracked using eMAR. 

(iii) Exclusion in accordance with 

paragraph (i)(2) of this section. Any 

eligible hospital or CAH with an average 

daily inpatient census of fewer than 10 

patients. 

(m) Stage 2 menu set criteria for 

eligible hospitals or CAHs. An eligible 

hospital or CAH must meet the measure 

criteria for three of the following 

objectives and associated measures. 

(1)(i) Objective. Record whether a 

patient 65 years old or older has an 

advance directive. 

(ii) Measure. Subject to paragraph (c) 

of this section, more than 50 percent of 

all unique patients 65 years old or older 

admitted to the eligible hospital’s or 

CAH’s inpatient department (POS 21) 

during the EHR reporting period have 

an indication of an advance directive 

status recorded as structured data. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54157 

(iii) Exclusion in accordance with 

paragraph (i)(2) of this section. Any 

eligible hospital or CAH that admits no 

patients age 65 years old or older during 

the EHR reporting period. 

(2)(i) Objective. Imaging results 

consisting of the image itself and any 

explanation or other accompanying 

information are accessible through 

Certified EHR Technology. 

(ii) Measure. Subject to paragraph (c) 

of this section, more than 10 percent of 

all tests whose result is an image 

ordered by an authorized provider of the 

eligible hospital or CAH for patients 

admitted to its inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period are accessible 

through Certified EHR Technology. 

(3)(i) Objective. Record patient family 

health history as structured data. 

(ii) Measure. More than 20 percent of 

all unique patients admitted to the 

eligible hospital or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period have a 

structured data entry for one or more 

first-degree relatives. 

(4)(i) Objective. Generate and transmit 

permissible discharge prescriptions 

electronically (eRx). 

(ii) Measure. More than 10 percent of 

hospital discharge medication orders for 

permissible prescriptions (for new, 

changed and refilled prescriptions) are 

queried for a drug formulary and 

transmitted electronically using 

Certified EHR Technology. 

(iii) Exclusion in accordance with 

paragraph (i)(2) of this section. Any 

eligible hospital or CAH that does not 

have an internal pharmacy that can 

accept electronic prescriptions and 

there are no pharmacies that accept 

electronic prescriptions within 10 miles 

at the start of its EHR reporting period. 

(5)(i) Objective. Record electronic 

notes in patient records. 

(ii) Measure: Enter at least one 

electronic progress note created, edited 

and signed by an authorized provider of 

the eligible hospital’s or CAH’s 

inpatient or emergency department 

(POS 21 or 23) for more than 30 percent 

of unique patients admitted to the 

eligible hospital or CAH’s inpatient or 

emergency department during the EHR 

reporting period. The text of the 

electronic note must be text-searchable 

and may contain drawings and other 

content. 

(6)(i) Objective. Provide structured 

electronic lab results to ambulatory 

providers. 

(ii) Measure. Hospital labs send 

structured electronic clinical lab results 

to the ordering provider for more than 

20 percent of electronic lab orders 

received. 

■ 9. Section 495.8 is amended as 

follows: 

■ A. Revising paragraph (a)(2)(i)(B) and 

(a)(2)(ii). 

■ B. Revising paragraphs (b)(2)(i)(B) and 

(b)(2)(ii). 

§ 495.8 Demonstration of meaningful use 

criteria. 

(a) * * * 

(2) * * * 

(i) * * * 

(B) Satisfied the required objectives 

and associated measures under § 495.6 

for the EP’s stage of meaningful use. 

* * * * * 

(ii) Reporting clinical quality 

information. Successfully report the 

clinical quality measures selected by 

CMS to CMS or the States, as applicable, 

in the form and manner specified by 

CMS or the States, as applicable. 

* * * * * 

(b) * * * 

(2) * * * 

(i) * * * 

(B) Satisfied the required objectives 

and associated measures under § 495.6 

for the eligible hospital or CAH’s stage 

of meaningful use. 

* * * * * 

(ii) Reporting clinical quality 

information. Successfully report the 

clinical quality measures selected by 

CMS to CMS or the States, as applicable, 

in the form and manner specified by 

CMS or the States, as applicable. 

* * * * * 

§ 495.10 [Amended] 

■ 10. In § 495.10, paragraph (a)(3) is 

amended by removing the phrase 

‘‘Business address and’’ and adding in 

its place the phrase ‘‘Business address, 

business email address, and’’. 

■ 11. Section 495.100 is amended by 

revising the definitions of ‘‘Qualifying 

CAH,’’ ‘‘Qualifying eligible professional 

(qualifying EP),’’ and ‘‘Qualifying 

hospital’’ to read as follows: 

§ 495.100 Definitions. 

* * * * * 

Qualifying CAH means a CAH that is 

a meaningful EHR user for the EHR 

reporting period applicable to a 

payment year or payment adjustment 

year in which a cost reporting period 

begins. 

Qualifying eligible professional 

(qualifying EP) means an EP who is a 

meaningful EHR user for the EHR 

reporting period applicable to a 

payment or payment adjustment year 

and who is not a hospital-based EP, as 

determined for that payment or payment 

adjustment year. 

Qualifying hospital means an eligible 

hospital that is a meaningful EHR user 

for the EHR reporting period applicable 

to a payment or payment adjustment 

year. 

■ 10. Section 495.102 is amended as 

follows: 

■ A. Revising paragraphs (c), (d)(1), and 

(d)(2)(iii). 

■ B. Adding paragraph (d)(2)(iv). 

■ C. Revising paragraph (d)(3). 

■ D. Adding paragraphs (d)(4) and (5). 

The revisions and additions read as 

follows: 

§ 495.102 Incentive payments to EPs. 

* * * * * 

(c) Increase in incentive payment 

limit for EPs who predominantly furnish 

services in a geographic HPSA. In the 

case of a qualifying EP who furnishes 

more than 50 percent of his or her 

covered professional services during the 

payment year in a geographic HPSA that 

is designated as of December 31 of the 

prior year, the incentive payment limit 

determined under paragraph (b) of this 

section is to be increased by 10 percent. 

(d) Payment adjustment effective in 

CY 2015 and subsequent years for 

nonqualifying EPs. (1)(i) Subject to 

paragraphs (d)(3) and (4) of this section, 

beginning 2015, for covered professional 

services furnished by an EP who is not 

hospital-based, and who is not a 

qualifying EP by virtue of not being a 

meaningful EHR user (for the EHR 

reporting period applicable to the 

payment adjustment year), the payment 

amount for such services is equal to the 

product of the applicable percent 

specified in paragraph (d)(2) of this 

section and the Medicare physician fee 

schedule amount for such services. 

(2) * * * 

(iii) For 2017, 97 percent. 

(iv) For 2018 and subsequent years, 97 

percent, except as provided in 

paragraph (d)(3) of this section. 

(3) Decrease in applicable percent in 

certain circumstances. If, beginning CY 

2018 and for each subsequent year, the 

Secretary finds that the proportion of 

EPs who are meaningful EHR users is 

less than 75 percent, the applicable 

percent must be decreased by 1 

percentage point for EPs from the 

applicable percent in the preceding 

year, but in no case will the applicable 

percent be less than 95 percent. 

(4) Exceptions. The Secretary may, on 

a case-by-case basis, exempt an EP from 

the application of the payment 

adjustment under paragraph (d)(1) of 

this section if the Secretary determines 

that compliance with the requirement 

for being a meaningful EHR user would 

result in a significant hardship for the 

EP. To be considered for an exception, 

an EP must submit, in the manner 

specified by CMS, an application 

mstockstill on DSK4VPTVN1PROD with RULES2

54158 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

demonstrating that it meets one or more 

of the criteria in this paragraph (d)(4) 

unless otherwise specified in the 

criteria. The Secretary’s determination 

to grant an EP an exemption may be 

renewed on an annual basis, provided 

that in no case may an EP be granted an 

exemption for more than 5 years. 

(i) During any 90-day period from the 

beginning of the year that is 2 years 

before the payment adjustment year to 

July 1 of the year preceding the payment 

adjustment year, the EP was located in 

an area without sufficient Internet 

access to comply with the meaningful 

use objectives requiring internet 

connectivity, and faced insurmountable 

barriers to obtaining such internet 

connectivity. Applications requesting 

this exception must be submitted no 

later than July 1 of the year before the 

applicable payment adjustment year. 

(ii) The EP has been practicing for less 

than 2 years. 

(iii)(A) During the calendar year that 

is 2 calendar years before the payment 

adjustment year, the EP that has 

previously demonstrated meaningful 

use faces extreme and uncontrollable 

circumstances that prevent it from 

becoming a meaningful EHR user. 

Applications requesting this exception 

must be submitted no later than July 1 

of the year before the applicable 

payment adjustment year. 

(B) During the calendar year 

preceding the payment adjustment year, 

the EP that has not previously 

demonstrated meaningful use faces 

extreme and uncontrollable 

circumstances that prevent it from 

becoming a meaningful EHR user. 

Applications requesting this exception 

must be submitted by July 1 of the year 

before the applicable payment 

adjustment year. 

(iv) An EP may request an exception 

through an application submitted by 

July 1 of the year before the applicable 

payment adjustment year due to 

difficulty in meeting meaningful use 

based on any one of the following 

during the period that begins 2 calendar 

years before the payment adjustment 

year through the application deadline: 

(A) The EP practices at multiple 

locations and can demonstrate inability 

to control the availability of Certified 

EHR Technology at one such practice 

location or a combination of practice 

locations, and where the location or 

locations constitute more than 50 

percent of their patient encounters. 

(B) The EP can demonstrate difficulty 

in meeting meaningful use on the basis 

of lack of face-to-face or telemedicine 

interaction with patients and lack of 

need for follow up with patients. 

(C) The EP has a primary specialty 

listed in PECOS as anesthesiology, 

radiology or pathology 6 months prior to 

the first day of the payment adjustments 

that would otherwise apply. Such an EP 

may be deemed to qualify for this 

exception, subject to the 5-year limit 

that applies to all exceptions under this 

paragraph. 

(5) Payment adjustments not 

applicable to hospital-based EPs. No 

payment adjustment under paragraphs 

(d)(1) through (3) of this section may be 

made in the case of a hospital-based 

eligible professional, as defined in 

§ 495.4. 

§ 495.106 [Amended] 

■ 12. In § 495.106, paragraph (e) is 

amended by removing the phrase ‘‘for a 

payment year’’ and adding the phrase 

‘‘for a payment adjustment year’’ in its 

place. 

■ 13. Section 495.200 is amended by— 

■ A. Adding definitions for ‘‘MA 

payment adjustment year,’’ and 

‘‘Potentially qualifying MA EPs and 

potentially qualifying MA-affiliated 

eligible hospitals’’ in alphabetical order. 

■ B. Revising paragraph (5) of the 

definition of ‘‘Qualifying MA EP’’. 

The additions and revision read as 

follows: 

§ 495.200 Definitions. 

* * * * * 

MA payment adjustment year 

means—(1) For qualifying MA 

organizations that receive an MA EHR 

incentive payment for at least 1 

payment year, calendar years beginning 

with CY 2015. 

(2) For MA-affiliated eligible 

hospitals, the applicable EHR reporting 

period for purposes of determining 

whether the MA organization is subject 

to a payment adjustment is the federal 

fiscal year ending in the MA payment 

adjustment year. 

(3) For MA EPs, the applicable EHR 

reporting period for purposes of 

determining whether the MA 

organization is subject to a payment 

adjustment is the calendar year 

concurrent with the payment 

adjustment year. 

* * * * * 

Potentially qualifying MA EPs and 

potentially qualifying MA-affiliated 

eligible hospitals are defined for 

purposes of this subpart in 

§ 495.202(a)(4). 

* * * * * 

Qualifying MA EP * * * 

(5) Is not a ‘‘hospital-based EP’’ (as 

defined in § 495.4 of this part) and in 

determining whether 90 percent or more 

of his or her covered professional 

services were furnished in a hospital 

setting, only covered professional 

services furnished to MA plan enrollees 

of the qualifying MA organization, in 

lieu of FFS patients, will be considered. 

* * * * * 

■ 14. Section 495.202 is amended as 

follows: 

■ A. Revising paragraph (b)(1). 

■ B. In paragraph (b)(2) introductory 

text, removing the cross-reference 

‘‘(b)(3)’’ and adding the cross-reference 

‘‘(4)’’ in its place. 

■ C. Revising paragraph (b)(2)(iii). 

■ D. Redesignating paragraphs (b)(3) 

and (4) as paragraphs (b)(4) and (5). 

■ E. Adding a new paragraph (b)(3). 

■ F. Revising newly redesignated 

paragraph (b)(4). 

■ G. Revising newly redesignated 

paragraphs (b)(5)(i) and (ii). 

The addition and revisions read as 

follows: 

§ 495.202 Identification of qualifying MA 

organizations, MA–EPs and MA-affiliated 

eligible hospitals. 

* * * * * 

(b) * * * 

(1) A qualifying MA organization, as 

part of its initial bid starting with plan 

year 2012, must make a preliminary 

identification of MA EPs and MAaffiliated eligible hospitals that the MA 

organization believes will be qualifying 

MA EPs and MA-affiliated eligible 

hospitals for which the organization is 

seeking incentive payments for the 

current plan year. 

(2) * * * 

(iii) NPI or CCN. 

* * * * * 

(3) When reporting under either 

paragraph (b)(1) or (4) of this section for 

purposes of receiving an incentive 

payment, a qualifying MA organization 

must also indicate whether more than 

50 percent of the covered Medicare 

professional services being furnished by 

a qualifying MA EP to MA plan 

enrollees of the MA organization are 

being furnished in a designated 

geographic HPSA (as defined in 

§ 495.100 of this part). 

(4) Final identification of qualifying 

and potentially qualifying, as 

applicable, MA EPs and MA-affiliated 

eligible hospitals must be made within 

2 months of the close of the payment 

year or the EHR reporting period that 

applies to the payment adjustment year 

as defined in § 495.200. 

(5) * * * 

(i) Identify all MA EPs and MAaffiliated eligible hospitals of the MA 

organization that the MA organization 

believes will be either qualifying or 

potentially qualifying; 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54159 

(ii) Include information specified in 

paragraph (b)(2)(i) through (iii) of this 

section for each professional or hospital; 

and 

* * * * * 

■ 15. Section 495.204 is amended as 

follows: 

■ A. Revising the section heading. 

■ B. Revising paragraphs (b)(2) and 

(b)(4) introductory text, and (b)(4)(i) and 

(ii). 

■ C. Redesignating paragraph (e) as 

paragraph (f). 

■ D. Adding new paragraphs (e), (f)(5), 

and (g). 

The revisions and additions read as 

follows: 

§ 495.204 Incentive payments to qualifying 

MA organizations for qualifying MA–EPs 

and qualifying MA-affiliated eligible 

hospitals. 

* * * * * 

(b) * * * 

(2) The qualifying MA organization 

must report to CMS within 2 months of 

the close of the calendar year, the 

aggregate annual amount of revenue 

attributable to providing services that 

would otherwise be covered as 

professional services under Part B 

received by each qualifying MA EP for 

enrollees in MA plans of the MA 

organization in the payment year. 

* * * * * 

(4) CMS requires the qualifying MA 

organization to develop a 

methodological proposal for estimating 

the portion of each qualifying MA EP’s 

salary or revenue attributable to 

providing services that would otherwise 

be covered as professional services 

under Part B to MA plan enrollees of the 

MA organization in the payment year. 

The methodological proposal— 

(i) Must be approved by CMS; and 

(ii) May include an additional amount 

related to overhead, where appropriate, 

estimated to account for the MAenrollee related Part B practice costs of 

the qualifying MA EP. 

* * * * * 

(e) Potential increase in incentive 

payment for furnishing services in a 

geographic HPSA. In the case of a 

qualifying MA EP who furnishes more 

than 50 percent of his or her covered 

professional services to MA plan 

enrollees of the qualifying MA 

organization during a payment year in a 

geographic HPSA, the maximum 

amounts referred to in paragraph (b)(3) 

of this section are increased by 10 

percent. 

(f) * * * 

(5) If an MA EP, or entity that 

employs an MA EP, or in which an MA 

EP has a partnership interest, MAaffiliated eligible hospital, or other party 

contracting with the MA organization, 

fails to comply with an audit request to 

produce applicable documents or data, 

CMS recoups all or a portion of the 

incentive payment, based on the lack of 

applicable documents or data. 

(g) Coordination of payment with FFS 

or Medicaid EHR incentive programs. 

(1) If, after payment is made to an MA 

organization for an MA EP, it is 

determined that the MA EP is eligible 

for the full incentive payment under the 

Medicare FFS EHR Incentive Program or 

has received a payment under the 

Medicaid EHR Incentive Program, CMS 

recoups amounts applicable to the given 

MA EP from the MA organization’s 

monthly MA payment, or otherwise 

recoups the applicable amounts. 

(2) If, after payment is made to an MA 

organization for an MA-affiliated 

eligible hospital, it is determined that 

the hospital is ineligible for the 

incentive payment under the MA EHR 

Incentive Program, or has received a 

payment under the Medicare FFS EHR 

Incentive Program, or if it is determined 

that all or part of the payment should 

not have been made on behalf of the 

MA-affiliated eligible hospital, CMS 

recoups amounts applicable to the given 

MA-affiliated eligible hospital from the 

MA organization’s monthly MA 

payment, or otherwise recoups the 

applicable amounts. 

■ 16. Section 495.208 is amended as 

follows: 

■ A. Redesignating paragraphs (a) 

through (c) as paragraphs (d) through (f). 

■ B. Adding new paragraphs (a) through 

(c). 

The additions read as follows: 

§ 495.208 Avoiding duplicate payment. 

(a) CMS requires a qualifying MA 

organization that registers MA EPs for 

the purpose of participating in the MA 

EHR Incentive Program to notify each of 

the MA EPs for which it is claiming an 

incentive payment that the MA 

organization intends to claim, or has 

claimed, the MA EP for the current plan 

year under the MA EHR Incentive 

Program. 

(b) The notice must make clear that 

the MA EP may still directly receive an 

EHR incentive payment if the MA EP is 

entitled to a full incentive payment 

under the FFS portion of the EHR 

Incentive Program, or if the MA EP 

registered to participate under the 

Medicaid portion of the EHR Incentive 

Program and is entitled to payment 

under that program—in both of which 

cases no payment would be made for 

the EP under the MA EHR incentive 

program. 

(c) An attestation by the qualifying 

MA organization that the qualifying MA 

organization provided notice to its MA 

EPs in accordance with this section 

must be required at the time that 

meaningful use attestations are due with 

respect to MA EPs for the payment year. 

* * * * * 

■ 17. Section 495.210 is amended by 

revising paragraphs (b) and (c) to read 

as follows: 

§ 495.210 Meaningful EHR user attestation 

* * * * * 

(b) Qualifying MA organizations are 

required to attest within 2 months after 

the close of a calendar year whether 

each qualifying MA EP is a meaningful 

EHR user. 

(c) Qualifying MA organizations are 

required to attest within 2 months after 

close of the FY whether each qualifying 

MA-affiliated eligible hospital is a 

meaningful EHR user. 

■ 18. Add § 495.211 to subpart C to read 

as follows: 

§ 495.211 Payment adjustments effective 

for 2015 and subsequent MA payment years 

with respect to MA EPs and MA-affiliated 

eligible hospitals. 

(a) In general. Beginning for MA 

payment adjustment year 2015, payment 

adjustments set forth in this section are 

made to prospective payments (issued 

under section 1853(a)(1)(A) of the Act) 

of qualifying MA organizations that 

previously received incentive payments 

under the MA EHR Incentive Program, 

if all or a portion of the MA–EPs and 

MA-affiliated eligible hospitals that 

would meet the definition of qualifying 

MA–EPs or qualifying MA-affiliated 

eligible hospitals (but for their 

demonstration of meaningful use) are 

not meaningful EHR users. 

(b) Adjustment based on payment 

adjustment year. The payment 

adjustment is calculated based on the 

payment adjustment year. 

(c) Separate application of 

adjustments for MA EPs and MAaffiliated eligible hospitals. The 

payment adjustments identified in 

paragraphs (d) and (e) of this section are 

applied separately. Paragraph (d) of this 

section applies only to qualifying MA 

organizations that received payment for 

any MA payment year for qualifying MA 

EPs under § 495.204. Paragraph (e) of 

this section applies only to qualifying 

MA organizations that received payment 

for any MA payment year for qualifying 

MA-affiliated eligible hospitals under 

§ 495.204. 

(d) Payment adjustments effective for 

2015 and subsequent years with respect 

to MA EPs. (1) For payment adjustment 

year 2015, and subsequent payment 

mstockstill on DSK4VPTVN1PROD with RULES2

54160 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

adjustment years, if a qualifying MA EP 

is not a meaningful EHR user during the 

payment adjustment year, CMS— 

(i) Determines a payment adjustment 

based on data from the payment 

adjustment year; and 

(ii) Collects the payment adjustment 

owed by adjusting a subsequent year’s 

prospective payment or payments 

(issued under section 1853(a)(1)(A) of 

the Act), or by otherwise collecting the 

payment adjustment, if, in the year of 

collection, the MA organization does 

not have an MA contract with CMS. 

(2) Beginning for payment adjustment 

year 2015, a qualifying MA organization 

that previously received incentive 

payments must, for each payment 

adjustment year, report to CMS the 

following: 

[the total number of potentially 

qualifying MA EPs]/[(the total 

number of potentially qualifying 

MA EPs) + (the total number of 

qualifying MA EPs)]. 

(3) The monthly prospective payment 

amount paid under section 

1853(a)(1)(A) of the Act for the payment 

adjustment year is adjusted by the 

product of— 

(i) The percent calculated in 

accordance with paragraph (d)(2) of this 

section; 

(ii) The Medicare Physician 

Expenditure Proportion percent, which 

is CMS’s estimate of proportion of 

expenditures under Parts A and B that 

are not attributable to Part C that are 

attributable to expenditures for 

physicians’ services, adjusted for the 

proportion of expenditures that are 

provided by EPs that are neither 

qualifying nor potentially qualifying 

MA EPs with respect to a qualifying MA 

organization; and 

(iii) The applicable percent identified 

in paragraph (d)(4) of this section. 

(4) Applicable percent. The applicable 

percent is as follows: 

(i) For 2015, 1 percent; 

(ii) For 2016, 2 percent; 

(iii) For 2017, 3 percent. 

(iv) For 2018, 3 percent, except, in the 

case described in paragraph (d)(4)(vi) of 

this section, 4 percent. 

(v) For 2019 and each subsequent 

year, 3 percent, except, in the case 

described in paragraph (d)(4)(vi) of this 

section, the percent from the prior year 

plus 1 percent. In no case will the 

applicable percent be higher than 5 

percent. 

(vi) Beginning with payment 

adjustment year 2018, if the percentage 

in paragraph (d)(2) of this section is 

more than 25 percent, the applicable 

percent is increased in accordance with 

paragraphs (d)(4)(iv) and (v) of this 

section. 

(e) Payment adjustments effective for 

2015 and subsequent years with respect 

to MA-affiliated eligible hospitals. (1)(i) 

The payment adjustment set forth in 

this paragraph (e) applies if a qualifying 

MA organization that previously 

received an incentive payment (or a 

potentially qualifying MA-affiliated 

eligible hospital on behalf of its 

qualifying MA organization) attests that 

a qualifying MA-affiliated eligible 

hospital is not a meaningful EHR user 

for a payment adjustment year. 

(ii) The payment adjustment is 

calculated by multiplying the qualifying 

MA organization’s monthly prospective 

payment for the payment adjustment 

year under section 1853(a)(1)(A) of the 

Act by the percent set forth in paragraph 

(e)(2) of this section. 

(2) The percent set forth in this 

paragraph (e) is the product of— 

(i) The percentage point reduction to 

the applicable percentage increase in 

the market basket index for the relevant 

Federal fiscal year as a result of 

§ 412.64(d)(3) of this chapter; 

(ii) The Medicare Hospital 

Expenditure Proportion percent 

specified in paragraph (e)(3) of this 

section; and 

(iii) The percent of qualifying and 

potentially qualifying MA-affiliated 

eligible hospitals that are not 

meaningful EHR users. Qualifying MA 

organizations are required to report to 

CMS 

[the number of potentially qualifying 

MA-affiliated eligible hospitals]/ 

[(the total number of potentially 

qualifying MA-affiliated eligible 

hospitals) + (the total number of 

qualifying MA-affiliated eligible 

hospitals)]. 

(3) The Medicare Hospital 

Expenditure Proportion for a year is the 

Secretary’s estimate of expenditures 

under Parts A and B that are not 

attributable to Part C, that are 

attributable to expenditures for 

inpatient hospital services, adjusted for 

the proportion of expenditures that are 

provided by hospitals that are neither 

qualifying nor potentially qualifying 

MA-affiliated eligible hospitals with 

respect to a qualifying MA organization. 

■ 19. Section 495.302 is amended as 

follows: 

■ A. In the definition of ‘‘Adopt, 

implement or upgrade,’’ by revising 

paragraph (1). 

■ B. In the definition of ‘‘Children’s 

hospital,’’ by revising paragraph (1), 

redesignating paragraph (2) as paragraph 

(3), and adding a new paragraph (2). 

■ C. In the definition of ‘‘Practices 

predominantly,’’ by removing the 

phrase ‘‘in the most recent calendar 

year’’ and adding the phrase ‘‘(within 

the most recent calendar year or, as an 

optional State alternative beginning for 

payment year 2013, within the 12- 

month period preceding attestation)’’. 

The revisions and addition read as 

follows: 

§ 495.302 Definitions. 

* * * * * 

Adopt, implement or upgrade * * * 

(1) Acquire, purchase, or secure 

access to certified EHR technology 

capable of meeting meaningful use 

requirements; 

* * * * * 

Children’s hospital * * * 

(1) Has a CMS certification number 

(CCN), (previously known as the 

Medicare provider number), that has the 

last 4 digits in the series 3300–3399; or 

(2) Does not have a CCN but has been 

provided an alternative number by CMS 

for purposes of enrollment in the 

Medicaid EHR Incentive Program as a 

children’s hospital and; 

* * * * * 

■ 20. Section 495.304 is amended as 

follows: 

■ A. In paragraphs (c)(1) and (2), by 

removing the phrase ‘‘individuals 

receiving Medicaid’’ and adding the 

phrase ’’ individuals enrolled in a 

Medicaid program’’ in its place. 

■ B. Adding paragraph (f). 

The addition reads as follows: 

§ 495.304 Medicaid provider scope and 

eligibility. 

* * * * * 

(f) Further patient volume 

requirements for the Medicaid EP. For 

payment year 2013 and all subsequent 

payment years, at least one clinical 

location used in the calculation of 

patient volume must have Certified EHR 

Technology— 

(1) During the payment year for which 

the EP attests to having adopted, 

implemented or upgraded Certified EHR 

Technology (for the first payment year); 

or 

(2) During the payment year for which 

the EP attests it is a meaningful EHR 

user. 

■ 21. Section 495.306 is amended as 

follows; 

■ A. Revising paragraphs (b), (c)(1)(i), 

(c)(2)(i), (c)(3)(i), (d)(1)(i)(A), 

(d)(1)(ii)(A), (d)(2)(i)(A), (d)(2)(ii)(A), 

and (e)(1) introductory text. 

■ B. In paragraph (e)(1)(i), by removing 

‘‘; or’’ and adding a period in its place. 

■ C. Adding paragraph (e)(1)(iii). 

■ D. Revising paragraph (e)(2)(i) 

introductory text. 

■ E. In paragraph (e)(2)(i)(A), by 

removing ‘‘; or’’ and adding a period in 

its place. 

mstockstill on DSK4VPTVN1PROD with RULES2

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 54161 

■ F. Adding paragraph (e)(2)(i)(C). 

■ G. Revising paragraph (e)(2)(ii) 

introductory text. 

■ H. In paragraph (e)(2)(ii)(A), by 

removing ‘‘; or’’ and adding a period in 

its place. 

■ I. Adding paragraph (e)(2)(ii)(C). 

■ J. Revising paragraph (e)(3) 

introductory text. 

■ K. In paragraphs (e)(3)(i) and (ii), by 

removing the semicolon and adding a 

period in its place. 

■ L. In paragraph (e)(3)(iii), by removing 

‘‘; or’’ and adding a period in its place. 

■ M. Redesignating paragraphs (e)(3)(iii) 

and (e)(3)(iv) as paragraphs (e)(3)(iv) 

and (e)(3)(v). 

■ N. Adding a new paragraph (e)(3)(iii). 

The revisions and additions read as 

follows: 

§ 495.306 Establishing patient volume. 

* * * * * 

(b) State option(s) through SMHP. (1) 

A State must submit through the SMHP 

the option or options it has selected for 

measuring patient volume. 

(2)(i) A State must select the method 

described in either paragraph (c) or 

paragraph (d) of this section (or both 

methods). 

(ii) Under paragraphs (c)(1)(i), 

(c)(2)(i), (c)(3)(i), (d)(1)(i), and (d)(2)(i) of 

this section, States may choose whether 

to allow eligible providers to calculate 

total Medicaid or total needy individual 

patient encounters in any representative 

continuous 90-day period in the 12 

months preceding the EP or eligible 

hospital’s attestation or based upon a 

representative, continuous 90-day 

period in the calendar year preceding 

the payment year for which the EP or 

eligible hospital is attesting. 

(3) In addition, or as an alternative to 

the method selected in paragraph (b)(2) 

of this section, a State may select the 

method described in paragraph (g) of 

this section. 

(c) * * * 

(1) * * * 

(i) The total Medicaid patient 

encounters in any representative, 

continuous 90-day period in the 

calendar year preceding the EP’s 

payment year, or in the 12 months 

before the EP’s attestation; by 

* * * * * 

(2) * * * 

(i) The total Medicaid encounters in 

any representative, continuous 90-day 

period in the fiscal year preceding the 

hospitals’ payment year or in the 12 

months before the hospital’s attestation; 

by 

* * * * * 

(3) * * * 

(i) The total needy individual patient 

encounters in any representative, 

continuous 90-day period in the 

calendar year preceding the EP’s 

payment year, or in the 12 months 

before the EP’s attestation; by 

* * * * * 

(d) * * * 

(1) * * * 

(i)(A) The total Medicaid patients 

assigned to the EP’s panel in any 

representative, continuous 90-day 

period in either the calendar year 

preceding the EP’s payment year, or the 

12 months before the EP’s attestation 

when at least one Medicaid encounter 

took place with the individual in the 24 

months before the beginning of the 90- 

day period; plus 

* * * * * 

(ii)(A) The total patients assigned to 

the provider in that same 90-day period 

with at least one encounter taking place 

with the patient during the 24 months 

before the beginning of the 90-day 

period; plus 

* * * * * 

(2) * * * 

(i)(A) The total Needy Individual 

patients assigned to the EP’s panel in 

any representative, continuous 90-day 

period in the either the calendar year 

preceding the EP’s payment year, or the 

12 months before the EP’s attestation 

when at least one Needy Individual 

encounter took place with the 

individual in the 24 months before the 

beginning of the same 90-day period; 

plus 

* * * * * 

(ii)(A) The total patients assigned to 

the provider in that same 90-day period 

with at least one encounter taking place 

with the patient during the 24 months 

before the beginning of the 90-day 

period, plus 

* * * * * 

(e) * * * 

(1) A Medicaid encounter means 

services rendered to an individual on 

any one day where: 

* * * * * 

(iii) The individual was enrolled in a 

Medicaid program (or a Medicaid 

demonstration project approved under 

section 1115 of the Act) at the time the 

billable service was provided. 

(2) * * * 

(i) A Medicaid encounter means 

services rendered to an individual per 

inpatient discharge when any of the 

following occur: 

(C) The individual was enrolled in a 

Medicaid program (or a Medicaid 

demonstration project approved under 

section 1115 of the Act) at the time the 

billable service was provided. 

(ii) A Medicaid encounter means 

services rendered in an emergency 

department on any 1 day if any of the 

following occur: 

* * * * * 

(C) The individual was enrolled in a 

Medicaid program (or a Medicaid 

demonstration project approved under 

section 1115 of the Act) at the time the 

billable service was provided. 

(3) For purposes of calculating needy 

individual patient volume, a needy 

patient encounter means services 

rendered to an individual on any 1 day 

if any of the following occur: 

* * * * * 

(iii) The individual was enrolled in a 

Medicaid program (or a Medicaid 

demonstration project approved under 

section 1115 of the Act) at the time the 

billable service was provided. 

* * * * * 

■ 22. Section 495.310 is amended as 

follows: 

■ A. Removing and reserving 

paragraphs (a)(1)(ii) and (a)(2)(ii). 

■ B. Adding paragraph (f)(8). 

■ C. Revising paragraph (g)(1)(i)(B) 

introductory text. 

■ D. In paragraphs (g)(1)(i)(B)(1) through 

(g)(1)(i)(B)(3), by removing the term 

‘‘discharge’’ wherever it appears and 

adding the term ‘‘acute-care inpatient 

discharge’’ in its place. 

■ E. In paragraph (g)(1)(i)(C), by 

removing the term ‘‘discharges’’ and 

adding the term ‘‘acute-care inpatient 

discharges’’ in its place. 

■ F. In paragraphs (g)(2)(i)(A) and (B), 

(g)(2)(ii)(A), and (g)(2)(iii), by removing 

the phrase ‘‘inpatient-bed-days’’ 

wherever it appears and adding the 

phrase ‘‘acute care inpatient-bed-days’’ 

in its place. 

The addition and revision read as 

follows: 

§ 495.310 Medicaid provider incentive 

payments. 

* * * * * 

(f) * * * 

(8) The aggregate EHR hospital 

incentive amount calculated under 

paragraph (g) of this section is 

determined by the State from which the 

eligible hospital receives its first 

payment year incentive. If a hospital 

receives incentive payments from other 

States in subsequent years, total 

incentive payments received over all 

payment years of the program can be no 

greater than the aggregate EHR incentive 

amount calculated by the initial State. 

(g) * * * 

(1) * * * 

(i) * * * 

(B) The discharge-related amount for 

the most recent continuous 12-month 

period selected by the State, but ending 

before the federal fiscal year that serves 

mstockstill on DSK4VPTVN1PROD with RULES2

54162 Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Rules and Regulations 

as the first payment year. The dischargerelated amount is the sum of the 

following, with acute-care inpatient 

discharges over the 12-month period 

and based upon the total acute-care 

inpatient discharges for the eligible 

hospital (regardless of any source of 

payment): 

* * * * * 

■ 23. Section 495.312 is amended by 

revising paragraph (c) to read as follows: 

§ 495.312 Process for payments. 

* * * * * 

(c) State’s role. (1) Except as specified 

in paragraph (c)(2) of this section, the 

State determines the provider’s 

eligibility for the EHR incentive 

payment under subparts A and D of this 

part and approves, processes, and makes 

timely payments using a process 

approved by CMS. 

(2) At the State’s option, CMS 

conducts the audits and handles any 

subsequent appeals, of whether eligible 

hospitals are meaningful EHR users on 

the States’ behalf. 

* * * * * 

■ 24. Section 495.316 is amended by 

revising paragraph (d)(2) to read as 

follows: 

§ 495.316 State monitoring and reporting 

regarding activities required to receive an 

incentive payment. 

* * * * * 

(d) * * * 

(2)(i) Subject to § 495.332, the State 

may propose a revised definition for 

Stage 1 of meaningful use of certified 

EHR technology, subject to CMS prior 

approval, but only with respect to the 

following objectives: 

(A) Generate lists of patients by 

specific conditions to use for quality 

improvement, reduction of disparities, 

research or outreach. 

(B) Capability to submit electronic 

data to immunization registries or 

immunization information systems and 

actual submission except where 

prohibited, and according to applicable 

law and practice. 

(C) Capability to submit electronic 

data on reportable (as required by State 

or local law) lab results to public health 

agencies and actual submission except 

where prohibited according to 

applicable law and practice. 

(D) Capability to submit electronic 

syndromic surveillance data to public 

health agencies and actual submission 

except where prohibited and according 

to applicable law and practice. 

(ii) Subject to § 495.332, the State may 

propose a revised definition for Stage 2 

of meaningful use of certified EHR 

technology, subject to CMS prior 

approval, but only with respect to the 

following objectives: 

(A) Generate lists of patients by 

specific conditions to use for quality 

improvement, reduction of disparities, 

research, or outreach. 

(B) Capability to submit electronic 

data to immunization registries or 

immunization information systems, 

except where prohibited, and in 

accordance with applicable law and 

practice. 

(C) Capability to submit electronic 

reportable laboratory results to public 

health agencies, except where 

prohibited, and in accordance with 

applicable law and practice. 

(D) Capability to provide electronic 

syndromic surveillance data to public 

health agencies, except where 

prohibited, and in accordance with 

applicable law and practice. 

(E) Capability to identify and report 

cancer cases to a public health central 

cancer registry, except where 

prohibited, and in accordance with 

applicable law and practice. 

(F) Capability to identify and report 

specific cases to a specialized registry 

(other than a cancer registry), except 

where prohibited, and in accordance 

with applicable law and practice. 

* * * * * 

■ 23. Section 495.332 is amended by: 

■ A. Adding paragraph (b)(6). 

■ B. Revising paragraph (c) introductory 

text. 

■ C. Removing paragraph (d)(9). 

■ D. Adding paragraph (g). 

The additions and revisions read as 

follows: 

§ 495.332 State Medicaid health 

information technology (HIT) plan 

requirements. 

* * * * * 

(b) * * * 

(6) For ensuring that at least one 

clinical location used for the calculation 

of the EP’s patient volume has Certified 

EHR Technology during the payment 

year for which the EP is attesting. 

(c) Monitoring and validation. Subject 

to paragraph (g) of this section, for 

monitoring and validation of 

information States must include the 

following: 

* * * * * 

(g) Optional—signed agreement. At 

the State’s option, the State may include 

a signed agreement indicating that the 

State does all of the following: 

(1) Designates CMS to conduct all 

audits and appeals of eligible hospitals’ 

meaningful use attestations. 

(2) Is bound by the audit and appeal 

findings described in paragraph (g)(1) of 

this section. 

(3) Performs any necessary 

recoupments if audits (and any 

subsequent appeals) described in 

paragraph (g)(1) of this section 

determine that an eligible hospital was 

not a meaningful EHR user. 

(4) Is liable for any FFP granted to the 

State to pay eligible hospitals that, upon 

audit (and any subsequent appeal) are 

determined not to have been meaningful 

EHR users. 

■ 26. Section 495.342 is amended by 

revising the introductory text to read as 

follows: 

§ 495.342 Annual HIT IAPD requirements. 

Each State is required to submit the 

HIT IAPD Updates 12 months from the 

date of the last CMS approved HIT IAPD 

and must contain the following: 

* * * * * 

■ 27. Section 495.370 is amended by 

adding paragraph (d) to read as follows: 

§ 495.370 Appeals process for a Medicaid 

provider receiving electronic health record 

incentive payments. 

* * * * * 

(d) This section does not apply in the 

case that CMS conducts the audits and 

handles any subsequent appeals under 

§ 495.312(c)(2) of this part. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: August 21, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: August 21, 2012. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2012–21050 Filed 8–23–12; 2:30 pm] 

BILLING CODE 4120–01–P 

mstockstill on DSK4VPTVN1PROD with RULES2