13698 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 412, 413, and 495 

[CMS–0044–P] 

RIN 0938–AQ84 

Medicare and Medicaid Programs; 

Electronic Health Record Incentive 

Program—Stage 2 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

specify 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 would specify 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 and other program 

participation requirements. This 

proposed rule would also revise certain 

Stage 1 criteria, as well as criteria that 

apply regardless of Stage, as finalized in 

the final rule titled Medicare and 

Medicaid Programs; Electronic Health 

Record Incentive Program published on 

July 28, 2010 in the Federal Register. 

The provisions included in the 

Medicaid section of this proposed rule 

(which relate to calculations of patient 

volume and hospital eligibility) would 

take effect shortly after finalization of 

this rule, not subject to the proposed 1 

year delay for Stage 2 of meaningful use 

of certified EHR technology. Changes to 

Stage 1 of meaningful use would take 

effect for 2013, but most would be 

optional until 2014. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on May 7, 2012. 

ADDRESSES: In commenting, please refer 

to file code CMS–0044–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–0044–P, P.O. Box 8013, Baltimore, 

MD 21244–8013. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–0044–P, Mail 

Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to the 

following addresses prior to the close of 

the comment period: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–1066 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Holland, (410) 786–1309, or 

Robert Anthony, (410) 786–6183, EHR 

Incentive Program issues. Jessica Kahn, 

(410) 786–9361, for Medicaid Incentive 

Program issues. James Slade, (410) 786– 

1073, or Matthew Guerand, (410) 786– 

1450, for Medicare Advantage issues. 

Travis Broome, (214) 767–4450, 

Medicare payment adjustment issues. 

Douglas Brown, (410) 786–0028, or 

Maria Durham, (410) 786–6978, for 

Clinical quality measures issues. 

Lawrence Clark, (410) 786–5081, for 

Administrative appeals process issues. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 

8:30 a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

Acronyms 

ARRA—American Recovery and 

Reinvestment Act of 2009 

AAC—Average Allowable Cost (of certified 

EHR technology) 

AIU—Adopt, Implement, Upgrade (certified 

EHR technology) 

CAH—Critical Access Hospital 

CAHPS—Consumer Assessment of 

Healthcare Providers and Systems 

CCN—CMS Certification Number 

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 Physician Order Entry 

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 

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Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 13699 

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 

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 

certified EHR technology) 

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 

PFFS—Private Fee-For-Service 

PHO—Physician Hospital Organization 

PHS—Public Health Service 

PHSA—Public Health Service Act 

PIHP—Prepaid Inpatient Health Plan 

POS—Place of Service 

PPO—Preferred Provider Organization 

PQRI—Physician Quality Reporting Initiative 

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. 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 

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) 

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 

3. Criteria for Selecting Clinical Quality 

Measures 

4. Proposed Clinical Quality Measures for 

Eligible Professionals 

a. Statutory and Other Considerations 

b. Clinical Quality Measures Proposed for 

Eligible Professionals for CY 2013 

c. Clinical Quality Measures Proposed for 

Eligible Professionals Beginning With CY 

2014 

5. Proposed 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. Proposed Clinical Quality Measures for 

Eligible Hospitals and Critical Access 

Hospitals 

a. Statutory and Other Considerations 

b. Clinical Quality Measures Proposed for 

Eligible Hospitals and CAHs for FY 2013 

7. Proposed 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 Certified 

EHR Technology 

a. Applicable Payment Adjustments for EPs 

Who Are Not Meaningful Users of 

Certified EHR Technology in CY 2015 

and Subsequent Calendar Years 

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. Payment Adjustment Not Applicable to 

Hospital-Based EPs 

3. Incentive Market Basket Adjustment 

Effective In FY 2015 and Subsequent 

Years for Eligible Hospitals Who Are Not 

Meaningful EHR Users 

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 to CAHs in FY 

2015 and Subsequent FYs 

5. Proposed Administrative Review Process 

of Certain Electronic Health Records 

Incentive Program Determinations 

a. Permissible Appeals 

b. Filing Requirements 

c. Preclusion of Administrative and 

Judicial Review 

d. Inchoate Review 

e. Informal Review Process Standards 

(1) Request for Supporting Documentation 

b. Informal Review Decision 

3. Final Reconsideration 

4. Exhaustion of Administrative Review 

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) 

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4. Avoiding Duplicate Payments 

5. Payment Adjustments Effective in 2015 

and Subsequent MA Payment 

Adjustment Years for Potentially 

Qualifying MA EPs and Potentially 

Qualifying MA-Affiliated Eligible 

Hospitals (§ 495.211) 

6. Appeals Process for MA Organizations 

F. Proposed 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 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. Collection of Information Requirements 

A. ICR Regarding Demonstration of 

Meaningful Use Criteria (§ 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) 

IV. Response to Comments 

V. Regulatory Impact Analysis 

A. Statement of Need 

B. Overall Impact 

C. Anticipated Effects 

D. Accounting Statement 

I. Executive Summary and Overview 

A. Executive Summary 

1. Purpose of Regulatory Action 

a. Need for the Regulatory Action 

In this proposed rule the Secretary of 

the Department of Health and Human 

Services (the Secretary) would specify 

Stage 2 criteria EPs, eligible hospitals, 

and CAHs must meet in order to qualify 

for an incentive payment, as well as 

introduce changes to the program 

timeline and detail payment 

adjustments. These proposed criteria 

were substantially adopted from the 

recommendations of the Health IT 

Policy Committee (HITPC), a Federal 

Advisory Committee that coordinates 

industry and provider input regarding 

the Medicare and Medicaid EHR 

Incentive Programs, as well as in 

consideration of current program data 

for the Medicare and Medicaid EHR 

Incentive Programs. 

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 eligible 

professionals (EPs), eligible hospitals, 

and critical access hospitals (CAHs), 

and Medicare Advantage (MA) 

organizations to promote the adoption 

and meaningful use of certified 

electronic health record (EHR) 

technology. 

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 

certified EHR technology), 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 certified EHR technology 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 statutory basis, 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 criteria, we finalized a separate 

set of core objectives and menu 

objectives for both EPs and eligible 

hospitals and CAHs. EPs and hospitals 

must meet or qualify for an exclusion to 

all of the core objectives and 5 out of the 

10 menu measures in order to qualify 

for an EHR incentive payment. In this 

proposed rule, we propose to maintain 

the same core-menu structure for the 

program for Stage 2. We propose that 

EPs must meet or qualify for an 

exclusion to 17 core objectives and 3 of 

5 menu objectives. We propose that 

eligible hospitals and CAHs must meet 

or qualify for an exclusion to 16 core 

objectives and 2 of 4 menu objectives. 

Nearly all of the Stage 1 core and menu 

objectives would be retained for Stage 2. 

The ‘‘exchange of key clinical 

information’’ core objective from Stage 1 

would be re-evaluated 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 would be 

removed because it would be replaced 

by an ‘‘electronic/online access’’ core 

objective. There are also multiple Stage 

1 objectives that would be 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. 

For EPs, we propose a set of clinical 

quality measures beginning in 2014 that 

align with existing quality programs 

such as measures used for the Physician 

Quality Reporting System (PQRS), CMS 

Shared Savings Program, and National 

Council for Quality Assurance (NCQA) 

for medical home accreditation, as well 

as those proposed under Children’s 

Health Insurance Program 

Reauthorization Act (CHIPRA) and 

under ACA Section 2701. For eligible 

hospitals and CAHs, the set of CQMs we 

propose beginning in 2014 would align 

with the Hospital Inpatient Quality 

Reporting (HIQR) and the Joint 

Commission’s hospital quality 

measures. 

This proposed rule also outlines a 

process by which EPs, eligible hospitals, 

and CAHs would submit CQM data 

electronically, reducing the associated 

burden of reporting on quality measures 

for providers. We are soliciting public 

feedback on several mechanisms for 

electronic CQM reporting, including 

aggregate-level electronic reporting 

group reporting options; and through 

existing quality reporting systems. 

Within these mechanisms of reporting, 

we outline different approaches to CQM 

reporting that would require EPs to 

report 12 CQMs and eligible hospitals 

and CAHs to report 24 CQMs in total. 

c. Payment Adjustments and Exceptions 

Medicare payment adjustments are 

required by statute to take effect in 

2015. We propose a process by which 

payment adjustment would be 

determined by a prior reporting period. 

Therefore, we propose that any 

successful meaningful user in 2013 

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Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 13701 

would avoid payment adjustment in 

2015. Also, any Medicare provider that 

first meets meaningful use in 2014 

would avoid the penalty if they are able 

to demonstrate meaningful use at least 

3 months prior to the end of the 

calendar or fiscal year (respectively) and 

meet the registration and attestation 

requirement by July 1, 2014 (eligible 

hospitals) or October 1, 2014 (EPs). 

We also propose exceptions to these 

payment adjustments. This proposed 

rule outlines three categories of 

exceptions based on the lack of 

availability of Internet access or barriers 

to obtaining IT infrastructure, a timelimited exception for newly practicing 

EPs or new hospitals who would not 

otherwise be able to avoid payment 

adjustments, and unforeseen 

circumstances such as natural disasters 

that would be handled on a case-by-case 

basis. We also solicit comment on a 

fourth category of exception due to a 

combination of clinical features limiting 

a provider’s interaction with patients 

and lack of control over the availability 

of Certified EHR technology at their 

practice locations. 

d. Modifications to Medicaid EHR 

Incentive Program 

We propose to expand the definition 

of what constitutes a Medicaid patient 

encounter, which is a required 

eligibility threshold for the Medicaid 

EHR Incentive Programs. We propose to 

include encounters for individuals 

enrolled in a Medicaid program, 

including Title XXI-funded Medicaid 

expansion encounters (but not separate 

CHIP programs. We also propose 

flexibility in the look-back period for 

patient volume to be over the 12 months 

preceding attestation, not tied to the 

prior calendar year. 

We also propose to make 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. 

e. Stage 2 Timeline Delay 

Finally, we propose a minor delay of 

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 for Medicare 

in 2011 would begin using Stage 2 

criteria in 2013. This proposed rule 

delays the onset of those Stage 2 criteria 

until 2014, which we believe provides 

the needed time for vendors to develop 

Certified EHR Technology. 

3. Summary of Costs and Benefits 

This proposed 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 proposed rule. The total 

Federal cost of the Medicare and 

Medicaid EHR Incentive Programs is 

estimated to be $14.6 billion in transfers 

between 2014 and 2019. In this 

proposed rule we have not quantified 

the overall benefits to the industry, nor 

to eligible hospitals, or EPs 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. 

Fiscal year 

Medicare eligible Medicaid eligible 

Total 

Hospitals Professionals Hospitals Professionals 

2014 ..................................................................................... $1.3 $1.2 $0.4 $0.8 $3.7 

2015 ..................................................................................... 1.2 1.1 0.5 0.9 3.7 

2016 ..................................................................................... 0.6 0.8 0.9 1.0 3.3 

2017 ..................................................................................... 0.0 0.2 1.0 1.0 2.2 

2018 ..................................................................................... ¥0.2 ¥0.2 0.6 0.9 1.1 

2019 ..................................................................................... ¥0.0 ¥0.2 0.1 0.7 0.6 

Amounts are in 2012 billions. 

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 eligible 

professionals (EPs), eligible hospitals, 

and critical access hospitals (CAHs), 

and Medicare Advantage (MA) 

Organizations to promote the adoption 

and meaningful use of certified 

electronic health record (EHR) 

technology. On July 28, 2010 we 

published in the Federal Register (75 

FR 44313 through 44588) a final rule 

titled ‘‘Medicare and Medicaid 

Programs; Electronic Health Record 

Incentive Program,’’ that specified the 

Stage 1 criteria 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 final rule (75 FR 44316).) 

In that final rule, we also detailed that 

the Medicare and Medicaid EHR 

Incentive Programs would 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 Certified EHR 

Technology and the standards and 

certification criteria for Certified EHR 

Technology were coordinated. Current 

ONC regulations may be found at 45 

CFR part 170. For Stage 2, CMS and 

ONC will again work together to align 

our regulations. 

We urge those interested in this 

proposed rule to also review the ONC 

proposed rule on standards and 

implementation specifications for 

Certified EHR Technology. Readers may 

also visit http://healthit.hhs.gov and 

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

EHRincentiveprograms for more 

information on the efforts at the 

Department of Health and Human 

Services (HHS) to advance HIT 

initiatives. 

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13702 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 

II. Provisions of the Proposed 

Regulations 

A. Definitions Across the Medicare FFS, 

Medicare Advantage, and Medicaid 

Programs 

1. Uniform Definitions 

In the Stage 1 final rule, we finalized 

many uniform definitions for the 

Medicare FFS, MA, and Medicaid EHR 

incentive programs. These definitions 

are set forth in part 495 subpart A of the 

regulations, and we are proposing to 

maintain most of these definitions, 

including, for example, ‘‘Certified EHR 

Technology,’’ ‘‘Qualified EHR,’’ 

‘‘Payment Year,’’ and ‘‘First, Second, 

Third, Fourth, Fifth, and Sixth Payment 

Year.’’ We note that our definitions of 

‘‘Certified EHR Technology’’ 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 

proposed rule that is published 

elsewhere in this issue of the Federal 

Register. We are revising the 

descriptions of the EHR reporting period 

to clarify that for providers who are 

demonstrating meaningful for the first 

time their EHR reporting period is 90 

days regardless of payment year. We 

propose 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, 

as discussed in section II.D. of this 

proposed rule. 

2. Meaningful EHR User 

We propose to include clinical quality 

measure reporting as part of the 

definition of ‘‘meaningful EHR user’’ 

instead of as a separate meaningful use 

objective under 42 CFR 495.6. This 

change is explained in section II.A.3.d. 

in the context of the proposed Stage 2 

criteria for meaningful use. 

The third paragraph of the definition 

of meaningful EHR user at 42 CFR 495.4 

currently read as follows: ‘‘(3) To be 

considered a meaningful EHR user, at 

least 50 percent of an EP’s patient 

encounters during the EHR reporting 

period during the payment year must 

occur at a practice/location or practices/ 

locations equipped with certified EHR 

technology.’’ We propose to revise the 

third paragraph of the definition of 

meaningful EHR user at 42 CFR 495.4 to 

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 Certified EHR 

Technology.’’ This change is to include 

the payment adjustment in this 

definition. Currently, it only refers to 

the incentives. 

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, 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 Certified EHR 

Technology if they are to receive 

incentives under Title XIX. Certified 

EHR Technology 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, 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. 

Based on public and stakeholder 

input received during our Stage 1 

rulemaking, 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 

Certified EHR Technology 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 July 28, 2010, and this rule 

outlines our proposed Stage 2 approach. 

We currently anticipate at least one 

additional update, and anticipate 

updating the Stage 3 criteria with 

another proposed rule by early 2014. 

The stages represent an initial graduated 

approach to arriving at the ultimate 

goal. 

• Stage 1: 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 Certified EHR 

Technology that will allow for 

continuous quality improvement and 

ease of information exchange. By having 

these functionalities in certified EHR 

technology 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 Certified 

EHR Technology. 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 proposing 

certain changes to the Stage 1 criteria in 

section II.B.3.b. of this proposed rule. 

• Stage 2: Our Stage 2 goals, 

consistent with other provisions of 

Medicare and Medicaid law, 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 encourage the use of health IT 

for continuous quality improvement at 

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the point of care and the exchange of 

information in the most structured 

format possible. Stage 2 meaningful use 

requirements include rigorous 

expectations for health information 

exchange including: more demanding 

requirements for e-prescribing; 

incorporating structured laboratory 

results; and the expectation that 

providers will electronically transmit 

patient care summaries to support 

transitions in care across unaffiliated 

providers, settings and EHR systems. 

Increasingly robust expectations for 

health information exchange in Stage 2 

and Stage 3 will support the goal that 

information follows the patient. In 

addition, as we forecasted in the Stage 

1 final rule, we now consider nearly 

every objective that was optional for 

Stage 1 to be required in Stage 2, and 

we reevaluated the thresholds and 

exclusions of all the measures. 

• 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, 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 (as described later in this section) 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 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 with 

our expected timeline for the stages of 

meaningful use. 

TABLE 1—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 are proposing changes to this 

timeline as well as its extension beyond 

2014. Under the timeline used in the 

Stage 1 final rule (75 FR 44323), 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 or October 1, 2012, respectively. 

We anticipate publishing a final rule by 

summer 2012. The HIT Policy 

Committee recommended we delay by 1 

year the start of Stage 2 for providers 

who became meaningful EHR users in 

2011. Stage 2 of meaningful use requires 

changes to both technology and 

workflow that cannot reasonably be 

expected to be completed in the time 

between the publication of the final rule 

and the start of the EHR reporting 

periods. We have heard similar 

concerns from other stakeholders and 

agree that, based on our proposed 

definition of meaningful use for Stage 2, 

providers could have difficulty 

implementing these changes in time. 

Therefore, we are proposing a 1-year 

extension of Stage 1 of meaningful use 

for providers who successfully 

demonstrated meaningful use for 2011. 

Our proposed timeline through 2021 is 

displayed in Table 2. We refer readers 

to II.D.2 of this proposed rule for a 

discussion of the applicable EHR 

reporting period that would be used to 

determine whether providers are subject 

to payment adjustments. 

TABLE 2—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. 

Please note 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. 

Medicaid EPs and eligible hospitals can 

receive a Medicaid EHR incentive 

payment for ‘‘adopting, implementing, 

and upgrading’’ (AIU) to Certified EHR 

Technology for their first payment year, 

which is not reflected in Table 2. 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 there will be a Stage 4 of 

meaningful use, we expect to update 

this table in the rulemaking for Stage 3. 

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b. Changes to Stage 1 Criteria for 

Meaningful Use 

We propose the following changes to 

the objectives and associated measures 

for Stage 1. As explained later in this 

proposed rule, most of these changes 

would be optional for Stage 1 in 2013 

and would be required for Stage 1 

beginning in 2014 (CY for EPs, FY for 

eligible hospitals/CAHs). We do not 

believe that this creates an additional 

hardship as providers would have the 

option of completing Stage 1 in the 

same manner in 2013 as in 2011 and 

2012, and in fact, the changes we 

propose create flexibility for EPs, 

eligible hospitals, and CAHs seeking to 

achieve Stage 1 meaningful use 

objectives. 

The current denominator for the 

CPOE objective measure for Stage 1 is 

the number of unique patients with at 

least one medication in their medication 

list seen by an EP or admitted to an 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period. We 

created this denominator in response to 

comments that our original Stage 1 

proposed denominator for this measure, 

the number of orders for medications, is 

difficult to measure. Following 

publication of the final rule, we have 

received nearly unanimous feedback 

from providers that the logical 

denominator for this measure is the 

number of orders for medications and 

that it is measurable. For more details 

please reference the discussion of the 

Stage 2 CPOE objective. Beginning in 

2013 (CY for EPs, FY for eligible 

hospitals/CAHs), we propose to allow 

providers in Stage 1 to 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 proposed CPOE 

objective in the Stage 2 criteria section). 

A provider seeking to meet Stage 1 in 

2013 could use either the current or the 

proposed alternative denominator to 

calculate the percentage for the CPOE 

measure. 

Starting with the EHR reporting 

periods in FY/CY 2014, the proposed 

‘‘alternative denominator’’ would be 

required for all providers in Stage 1 and 

Stage 2. 

For the objective of record and chart 

changes in vital signs, our Stage 2 

proposal 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). 

We propose an identical change to the 

Stage 1 exclusion as well, starting in CY 

2013. We also propose 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 propose identical changes 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 

would be an alternative in 2013 to the 

current Stage 1 requirements and would 

be required for Stage 1 beginning in 

2014. We have found the objective of 

‘‘capability to exchange key clinical 

information’’ to be surprisingly difficult 

for providers to understand, which has 

made the objective considerably more 

difficult to achieve than we envisioned 

in the Stage 1 final rule. As the measure 

for this objective is simply a test with 

no associated requirement for follow-up 

submission, we are concerned the value 

of this objective is not sufficient to 

justify the burden of compliance. 

However, we also strongly believe that 

meaningful use of EHRs must ultimately 

involve real and ongoing electronic 

health information exchange to support 

care coordination, as the Stage 2 

objectives on this subject (described 

below) make clear. We considered four 

options for this objective, and welcome 

comment on all four, that variously 

reduce or eliminate the burden of the 

objective or increase the value of the 

objective. The first option we 

considered is removal of this objective. 

This acknowledges our experience with 

Stage 1 and the limited benefit of just a 

test. The second option is to require that 

the test be successful. This would 

increase the value of the objective and 

eliminate a common question we 

receive on what happens if the test is 

unsuccessful. The third option is 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 from the 

menu set. This would eliminate the 

burden and complexity of the test, but 

preserve the domain of care 

coordination for Stage 1. The fourth 

option is 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. This would increase 

the benefit of the objective and reduce 

the complexity of the defining the 

parameters of the test, but potentially 

increases the real burden of compliance 

significantly beyond what is currently 

included in Stage 1. We are proposing 

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). In Stage 2, we 

propose to move to actual use cases of 

electronic exchange of health 

information as discussed later in this 

proposed rule, which would require 

significant testing in the years of Stage 

1. We encourage comments on all four 

options and will evaluate them again in 

light of the public comment received. 

We propose for Stage 2 a new method 

for making patient information available 

electronically, which would enable 

patients to view online and download 

their health information and hospital 

admission information. We discuss in 

the Stage 2 criteria section the proposed 

‘‘view, download, and transmit’’ 

objectives for EPs and hospitals. Starting 

in 2014, Certified EHR Technology will 

no longer be certified to the Stage 1 EP 

and hospital core objectives of 

providing patients with electronic 

copies of their health information and 

discharge instructions upon request, nor 

will it support the Stage 1 EP menu 

objective of providing patients with 

timely electronic access to their health 

information. Therefore starting in 2014, 

for Stage 1, we propose to replace these 

objectives with the new ‘‘view online, 

download and transmit’’ objectives. We 

discuss these objectives further in our 

proposed Stage 2 criteria. 

We are proposing a revised definition 

of a meaningful EHR user which would 

incorporate the requirement to submit 

clinical quality measures, as discussed 

in section II.A.2. of this proposed rule, 

and as such are removing the objective 

to submit clinical quality measures 

beginning in 2013 and the associated 

regulation text under 45 CFR 495.6 for 

Stage 1 to conform with this change in 

the definition of a meaningful EHR user. 

For the Stage 1 public health 

objectives, beginning in 2013, we also 

propose to add ‘‘except where 

prohibited’’ to the regulation text, 

because we want 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). 

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TABLE 3—CHANGES TO STAGE 1 

Stage 1 objective Proposed 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–Only (Optional). 

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: Replacing the 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.

2014–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 ...........................................................

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. 

2013–Only (Optional). 

Record and chart changes in vital signs Change: Age Limitations on Growth Charts and Blood Pressure .........................

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.

2014–Onward 

(Required) 

Record and chart changes in vital signs Change: Changing the age and splitting the EP exclusion ...................................

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. 

2014–Onward 

(Required). 

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 42 CFR 495.6.

2013–Onward 

(Required) 

EP Objective: Provide patients with an 

electronic copy of their health information (including diagnostics test results, 

problem list, medication lists, medication allergies) upon request.

Change: Replace these three objectives with the Stage 2 objective and one of 

the two Stage 2 measures.

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.

2014–Onward 

(Required). 

Hospital Objective: Provide patients with 

an electronic copy of their discharge 

instructions and procedures at time of 

discharge, upon request.

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.

EP Objective: Provide patients with 

timely electronic access to their health 

information (including lab results, 

problem list, medication lists, medication allergies) within 4 business days 

of the information being available to 

the EP.

Hospital Objective: Provide patients the ability to view online, download and 

transmit information about a hospital admission.

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 42 CFR 495.6.

2013–Onward 

(Required). 

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c. State Flexibility for Stage 2 of 

Meaningful Use 

We propose 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, whether moved to the 

core or left 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 

ONC EHR certification criteria as 

finalized for Stage 2 of meaningful use. 

We solicit comment on extending 

State flexibility as described for Stage 2 

of meaningful use and whether this 

remains a useful tool for State Medicaid 

agencies. 

d. Stage 2 Criteria for Meaningful Use 

(Core Set and Menu Set) 

We are proposing 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 

propose to follow that approach for our 

Stage 2 core set with two exceptions. 

We are proposing 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 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 are also proposing 

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 are proposing new objectives for 

Stage 2, some of which would be part 

of the Stage 2 core set and others would 

make up the Stage 2 menu set, as 

discussed below with each objective. 

We are proposing to eliminate certain 

Stage 1 objectives for Stage 2, such as 

the objective for testing the capability to 

exchange key clinical information. We 

are also proposing 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 would 

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 are proposing a total of 17 core 

objectives and 5 menu objectives for 

EPs. We propose 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 by the number of 

exclusions applicable to the EP the 

number of menu set objectives that the 

EP would otherwise need to meet. We 

received feedback on Stage 1 that we 

have received 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, so we are proposing 

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 are proposing this change 

because we are concerned that under 

the current Stage 1 requirements 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 greater flexibility 

to do this in the selection of Stage 1 

menu objectives through 2013, we 

believe 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 have 

provided exclusions for the Stage 2 

menu objectives that we believe will 

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 currently intend 

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. 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. The same policy would 

also apply for the Stage 1 menu 

objectives for EPs beginning in 2014. 

We propose a total of 16 core 

objectives and 4 menu objectives for 

eligible hospitals and CAHs for Stage 2. 

We propose 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. 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. 

(1) Discussion of Whether Certain EPs, 

Eligible Hospitals or CAHs Can Meet All 

Stage 2 Meaningful Use Objectives 

Given Established Scopes of Practice 

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 discuss the barriers 

and include exclusions in our 

descriptions of the individual objectives 

later. We are proposing 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 recognize that at the time of 

publication, our data (derived internally 

from attestations) only reflects the 

meaningful use attestation from 

Medicare providers. Before the 

publication of the final rule, we plan on 

adjusting the data on the successful 

attestations to date to reflect the 

experience of successful Medicaid 

meaningful EHR users. This may result 

in changes to our current assumptions 

based upon the data available at the 

time of the proposed rule, especially 

given the different eligible professional 

types in the Medicaid EHR Incentive 

Program. It may be that different eligible 

professional types may have different 

levels of success in meeting the 

meaningful use measure thresholds, 

given their scope of practice. 

(2) EPs Practicing in Multiple Practices/ 

Locations 

We propose 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 

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during the EHR reporting period at a 

practice/location or practices/locations 

equipped with Certified EHR 

Technology. 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 

percent threshold through a 

combination of practices/locations 

equipped with Certified EHR 

Technology. For 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 

Certified EHR Technology 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 Certified EHR 

Technology 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 

Certified EHR Technology 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. 

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 have also received 

requests for clarification on what it 

means for a practice/location to be 

equipped with Certified EHR 

Technology. We define a practice/ 

location as equipped with Certified EHR 

Technology if the record of the patient 

encounter that occurs at that practice/ 

location is created and maintained in 

Certified EHR Technology. This can be 

accomplished in three ways: Certified 

EHR Technology could be permanently 

installed at the practice/location, the EP 

could bring Certified EHR Technology 

to the practice/location on a portable 

computing device, or the EP could 

access Certified EHR Technology 

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 Certified EHR Technology 

at the practice/location and then later 

input that information into Certified 

EHR Technology that exists at a 

different practice/location, we do not 

believe this process takes advantage of 

the value Certified EHR Technology 

offers. We are proposing 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. There is no 

interaction. The determination of 

whether an EP is hospital-based or not 

occurs prior to the application of this 

policy, so only non-hospital 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). 

(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 Certified EHR 

Technology, but including all patients 

in the denominators of other measures, 

to be complicated for providers to 

implement. We are proposing 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 Certified EHR 

Technology, making this distinction no 

longer relevant. 

We also continue our policy that EPs 

practicing in multiple locations do not 

have to include patients seen at 

practices/locations that are not 

equipped with Certified EHR 

Technology in the calculations of the 

meaningful use measures as long as the 

EP has 50 percent of their patient 

encounters during the EHR reporting 

period at locations equipped with 

Certified EHR Technology. 

We are proposing new objectives that 

could increase reporting burden. To 

minimize the burden, we are proposing 

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 wherever possible and if 

appropriate. To provide a check on the 

burden of reporting of meaningful use, 

we propose for Stage 2 to use 1 of 4 

denominators for each of the measures 

associated with the meaningful use 

objectives. We focus on denominators 

because the action that moves 

something from the denominator to the 

numerator usually requires the use of 

Certified EHR Technology by the 

provider. These actions are easily 

tracked by the technology. 

The four proposed 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. 

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 would 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 would 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 one-time 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 

would not be able to satisfy meaningful 

use, as they would 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 

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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. 

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, faceto-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. Transitions of care are 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 

proposed rule is only intended to apply 

to the EHR Incentive Programs and is 

not applicable to other Federal 

regulations.) 

The four proposed 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). 

• Inpatient bed days. 

• Transitions of care. 

The explanation of ‘‘unique patients’’ 

and ‘‘transitions of care’’ in the 

preceding paragraph for EPs also applies 

for eligible hospitals and CAHs. 

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). 

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 would 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. 

(4) Discussion of the Relationship of 

Meaningful Use to Certified EHR 

Technology 

We propose to continue our policy of 

linking each meaningful use objective to 

certification criteria for Certified EHR 

Technology. 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. 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 Certified EHR 

Technology. For example, in e-Rx and 

public health reporting, Certified EHR 

Technology applies standards to the 

message being sent and enables certain 

capabilities for transmission in 2014; 

however, to actually engage in e-Rx or 

public health reporting many steps must 

be taken despite these standards and 

capabilities such as contacting both 

parties and troubleshooting issues that 

may arise through the normal course of 

business. 

(5) Discussion of the Relationship 

Between a Stage 2 Meaningful Use 

Objective and its Associated Measure 

We propose 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, meeting the criteria of the 

measure means that the provider has 

met the objective for Stage 2. 

(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. 

We propose to continue to define 

CPOE as entailing 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. 

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 would 

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 this is a 

logical step in the progression of 

meaningful use. 

Our experience with Stage 1 of 

meaningful use demonstrated that our 

definition of CPOE in the Stage 1 final 

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rule does not indicate when in the 

ordering process the CPOE function 

must be utilized. We provided guidance 

at: https://questions.cms.hhs.gov/app/ 

answers/detail/a_id/10134/ on the Stage 

1 criteria to say 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. Our experience 

shows that the limiting criterion is the 

first time the order becomes part of the 

patient’s medical record rather than the 

limitation to licensed healthcare 

professionals entering the order. Our 

experience has also demonstrated that 

each provider must make the decision of 

whether the record of an order is part of 

the patient’s medical record 

independently as the possible variations 

in process and record keeping are too 

numerous for a universal statement on 

when in the process an order becomes 

part of the patient’s medical record. To 

further CPOE’s ability to improve safety 

and efficiency and to provide greater 

clarity for Stage 2 of meaningful use, we 

are proposing to redefine the point in 

the ordering process when CPOE must 

be utilized. We propose that to be 

considered CPOE, the CPOE function 

must be utilized to create the first record 

of any type for the order. This removes 

the possibility that a record of the order 

could be created prior to CPOE, but not 

be part of the patient’s medical record. 

In a practice, this means the originating 

provider (the provider whose judgment 

creates the order) must personally use 

the CPOE function, verbally 

communicate the order to someone else 

who will use the CPOE function, or give 

an electronic or written order that must 

not be retained in any way once the 

CPOE function has been utilized. This is 

a meaningful use requirement and does 

not affect any other legal or regulatory 

requirements as to what constitutes a 

patient’s health record or order. With 

this new proposal, we invite 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 nonlicensed 

healthcare professionals such as scribes. 

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. 

Our experience with Stage 1 of 

meaningful use has shown that a 

denominator of all orders created by the 

EP or in the hospital would not be 

unduly burdensome for providers. Many 

providers have voluntarily provided 

information on the number of 

medication orders in their clinic or 

hospital. However, this does not 

guarantee such a denominator would be 

feasible for all providers. We believe the 

EHRs can calculate a denominator of all 

orders entered into the Certified EHR 

Technology, with the numerator limited 

to those entered into Certified EHR 

Technology using CPOE. Potentially, 

this would exclude those orders that are 

never entered into the Certified EHR 

Technology in any manner. The 

provider would be responsible for 

including those orders in their 

denominator. However, we believe that 

providers using Certified EHR 

Technology use it as the patient’s 

medical record; therefore, an order not 

entered into Certified EHR Technology 

would be an order that is not entered 

into a patient’s medical record. For this 

reason, we expect that orders given for 

patients that are never entered into the 

Certified EHR Technology to be few in 

number or non-existent. We encourage 

comments on whether a denominator 

other than number of medication, 

laboratory, and radiology orders created 

by the EP or in the hospital would be 

needed for EPs and/or hospitals. For 

example, the HIT Policy Committee 

recommended a denominator of 

‘‘patients with at least one type of 

order.’’ We are proposing, however, a 

different denominator for this measure, 

which we believe would be possible to 

collect given our experience in Stage 1 

of meaningful use and a much more 

accurate measure of actual CPOE usage. 

The denominator of ‘‘patients with at 

least one type of order’’ is a proxy 

measure for the number of orders issued 

by the EP, eligible hospital or CAH. The 

accuracy of that proxy is dependent on 

the frequency in which an encounter 

results in an order. For example, an EP 

whose scope of practice is such that 

they order a medication on nearly every 

encounter would have every encounter 

as an opportunity to move the patient 

from the denominator to a numerator. 

The 2005 National Ambulatory Medical 

Care Survey (referenced in the Stage 1 

final rule, 75 FR 44333) found that 66 

percent of office-based visits had any 

type of medication order. EPs whose 

office visits are consistent with the 

survey findings would have a third 

fewer opportunities to move the patient 

from the denominator to the numerator. 

We believe a direct measure of the 

number of orders is feasible and more 

accurate as it is not dependent on the 

frequency of orders. We encourage 

comments on whether the barriers to 

collecting information for our proposed 

denominator would be greater in a 

hospital or ambulatory setting. As we 

noted previously, the denominator used 

in Stage 1 (as well as the denominator 

recommended by the HIT Policy 

Committee) is much more representative 

of CPOE use in a hospital setting than 

an ambulatory setting, so these settings 

could require different denominators or 

measures. We request comment on 

different denominators or measures and 

encourage 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. 

Based on our experience with 

attestation data from Stage 1, we 

continue to believe that the 60 percent 

threshold that we finalized previously 

for Stage 2 is appropriate. We also 

believe that this threshold translates to 

our new measure. The HIT Policy 

Committee recommended including 

laboratory and radiology orders in the 

measure, but as ‘‘yes/no’’ attestations of 

one order being entered using CPOE 

rather than at the 60 percent threshold. 

We believe this is unnecessary given the 

advance of CPOE. In our discussions 

with EPs, eligible hospitals and CAHs 

we find that they do not roll out CPOE 

with only one order type, but rather 

include medications, laboratory and 

radiology/imaging orders as a package. 

We are also concerned 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. We 

welcome comment on whether 

laboratory and radiology orders are 

sufficiently different in the use of CPOE 

that they would require a different 

threshold and whether such a threshold 

should be a lower percentage or a yes/ 

no attestation. 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of 

medication, radiology, and laboratory 

orders created by the EP or authorized 

providers in the eligible hospital’s or 

CAH’s inpatient or emergency 

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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, laboratory and 

radiology orders during the EHR 

reporting period. 

To qualify for the exclusion, an EP’s 

total number of medication, laboratory 

and radiology orders collectively must 

be less than 100. For example, an EP 

who writes 75 medication orders, 50 

laboratory orders and no radiology 

orders during the EHR reporting period 

would not meet the exclusion. 

Consolidated Objective: Implement 

drug-drug and drug-allergy interaction 

checks. 

For Stage 2, we are proposing 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 continue to believe 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 believe it 

is appropriate to include this 

functionality as part of the objective for 

using clinical decision support. 

Proposed EP Objective: Generate and 

transmit permissible prescriptions 

electronically (eRx). 

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, Certified 

EHR Technology 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 

Certified EHR Technology 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 propose to continue to define 

prescription as the authorization by an 

EP to dispense a drug that would not be 

dispensed without such authorization. 

This includes authorization for refills of 

previously authorized drugs. We 

propose 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. However, as Stage 2 of 

meaningful use would not go into effect 

until 2014, it is possible that significant 

progress in the availability of products 

enabling the electronic prescribing of 

controlled substances may occur. We 

encourage comments addressing the 

current and expected availability of 

these products and whether the 

availability would be sufficient to 

include controlled substances in the 

Stage 2 measure for e-Rx or to warrant 

an additional measure for EPs to choose 

that would include controlled substance 

electronic prescriptions in the 

denominator. 

We do not believe that OTC 

medicines will be routinely 

electronically prescribed and propose to 

continue to exclude them from the 

definition of a prescription. However, 

we encourage public comment on this 

assumption. 

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 Certified EHR Technology 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 propose 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, the EP needs to use 

Certified EHR Technology 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 the standards included in 

certification of EHRs. 

We received many inquiries as to the 

alignment with this objective and the 

eRx payment adjustment authorized by 

the Medicare Improvements for Patients 

and Providers Act of 2008 (MIPPA). The 

HITECH Act phases out the adjustment 

starting in CY 2015 so alignment 

between the programs is no longer 

necessary. At the time of publication of 

this proposed rule, the determination 

for CY 2013 MIPPA eRx payment 

adjustment will have already occurred. 

For these reasons alignment with Stage 

2 becomes a moot point. 

Proposed EP Measures: More than 65 

percent of all permissible prescriptions 

written by the EP are compared to at 

least one drug formulary and 

transmitted electronically using 

Certified EHR Technology. 

In Stage 1 of meaningful use, we 

adopted a measure of more than 40 

percent of all permissible prescriptions 

written by the EP are transmitted 

electronically using Certified EHR 

Technology. In the Stage 1 rule (75 FR 

44338), we acknowledged that there 

were reasons why a patient may prefer 

a paper prescription. A patient could 

have this preference for any number of 

reasons such as the desire to shop for 

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the best price (especially for patients in 

the Part D ‘‘donut hole’’), the ability to 

obtain medications through the 

Department of Veterans Affairs, lack of 

finances, indecision about whether to 

have the prescription filled locally or by 

mail order, and desire to use a 

manufacturer coupon to obtain a 

discount. We correspondingly lowered 

the threshold to 40 percent from 75 

percent as proposed for Stage 1 to 

account for patient preference for a 

paper prescription. While pharmacy 

acceptance of electronic prescriptions 

continues to accelerate, these patient 

preferences remain creating a ceiling for 

this threshold on which there is limited 

data with which to estimate. 

The HIT Policy Committee 

recommended an increase in the 

threshold of this measure from 40 

percent to 50 percent. The average 

successful Medicare meaningful EHR 

user rate currently exceeds 50 percent 

demonstrating to us that 50 percent does 

not exceed the ceiling created by patient 

preferences. We also believe that 

providers participating in Stage 2 will 

already have significant experience with 

this objective and can meet an even 

higher threshold. Therefore we are 

proposing a threshold of 65 percent for 

this measure. 

The ease with which an EP can meet 

this measure depends heavily on the 

availability of pharmacies in their local 

area that accept electronic prescriptions. 

We propose 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. For EP’s practicing at 

multiple locations, they are eligible for 

the exclusion if any of their practice 

locations that are equipped with 

Certified EHR Technology 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 have considered instances 

where an EP may prescribe medications 

in a facility (such as a nursing home or 

ambulatory surgery center) where they 

are compelled to use the facility’s 

ordering system, which may not be 

Certified EHR Technology. While we are 

not proposing exclusionary criteria 

related to this circumstance, we 

encourage comments on whether one is 

necessary or if the proposed 50 percent 

threshold is low enough to account for 

this situation. 

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. We 

recognize that not all drug formularies 

are linked to all Certified EHR 

Technologies, so we are not requiring 

that the formulary be relevant for each 

patient. Therefore, the comparison 

could return a result of formulary 

unavailable for that patient and 

medication combination and still allow 

the EP to meet the measure of this 

objective. This modification of the 

measure replaces the Stage 1 menu 

objective of ‘‘Implement drug-formulary 

checks’’ and is intended to provide 

better integration guidance for both EPs 

and their supporting vendors. 

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. 

• Numerator: The number of 

prescriptions in the denominator 

generated, compared to a drug 

formulary and transmitted 

electronically. 

• Threshold: The resulting percentage 

must be more than 65 percent in order 

for an EP to meet this measure. 

Exclusions: Any EP who writes fewer 

than 100 prescriptions during the EHR 

reporting period or does not have a 

pharmacy within their organization and 

there are no pharmacies that accept 

electronic prescriptions within 25 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. 

Consolidated Objective: Maintain 

active medication list. 

Consolidated Objective: Maintain 

active medication allergy list. 

For Stage 2, we are proposing 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 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 Certified EHR 

Technology. However, the continued 

demonstration of their meaningful use 

in Stage 2 is 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 are proposing 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 summary care 

record for each transition of care or 

referral.’’ EPs and hospitals would have 

to ensure the accuracy of these fields 

when providing the summary of care, 

which we believe will 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 

proposed rule published elsewhere in 

this issue of the Federal Register. 

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. 

The recording of demographic data 

benefits healthcare and population 

health. Gender, race, ethnicity, and age 

are all established risk factors for a large 

number of diseases and conditions. 

Having this information available to 

healthcare providers improves their 

ability to care for individual patients. 

This same information combined with 

preferred language and date and cause 

of death can create revealing data on the 

health of populations as small as the 

population treated by a single 

healthcare provider to the national 

population. Health disparities can be 

identified and risk factors for disease 

and conditions can be identified and 

refined, among other uses for this data. 

In order to obtain these benefits, 

especially for public health, it is 

important that information from 

different sources be comparable. For 

this reason, we propose to continue the 

use of the Office of Management and 

Budget (OMB) standards for race and 

ethnicity (http://www.whitehouse.gov/ 

omb/inforeg_statpolicy/#dr). As 

outlined in the OMB policy, more 

detailed descriptions of race can be 

used, but ultimately would need to be 

mapped to 1 of the 5 races included in 

the OMB standards. Current OMB 

standards align race categories with 

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every geographic location in the globe 

so there are not barriers to completing 

such mapping. We recognize that race is 

a social construct that varies across 

cultures and time which is why we fully 

support the use of other descriptions 

that can then be mapped using 

geography constructs to the OMB 

standards. There must also be the option 

for the selection of multiple races for a 

patient and an option for cases when a 

patient declines to provide the 

information. 

The recording of the cause of death 

raised many questions from providers in 

Stage 1 of meaningful use. Some cases 

are referred to medical examiners to 

determine the official cause of death 

while others are not. Individual hospital 

policies and local/State laws and 

regulations vary. For purposes of 

meaningful use, we refer to the 

preliminary cause of death recorded by 

the hospital. This preliminary cause is 

not required to be amended due to 

additional information, but the hospital 

may amend the information if they want 

to maintain the most accurate 

information. The recording of the 

preliminary cause of death also does not 

have to occur within a specified 

timeframe from the death. We believe 

these clarifications will enable hospitals 

to meet this measure, but we encourage 

comments on our description of 

recording the cause of death. 

In addition, we encourage public 

comment on the burden and ability of 

including disability status for patients 

as part of the data collection for this 

objective. We believe that the recording 

of disability status for certain patients 

can improve care coordination, and so 

we are considering making the 

recording of disability status an option 

for providers. We seek comment on the 

burden incorporating such an option 

would impose on EHR vendors, as well 

as the burden that collection of this data 

might impose on EPs, eligible hospitals, 

and CAHs. In addition, we request 

public comment on—(1) how to define 

the concept ‘‘disability status’’ in this 

context; and (2) whether the option to 

collect disability status for patients 

should be captured under the objective 

to record demographics, or if another 

objective would be more appropriate. 

We also seek comment on whether, 

we should also include the recording of 

gender identity and/or sexual 

orientation. We encourage commenters 

to identify the benefits of inclusion and 

the applicability across providers. 

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. 

For Stage 1 of meaningful use, we 

adopted a measure of 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) 

have demographics recorded as 

structured data. We agree with the HIT 

Policy Committee recommendation to 

increase the threshold of this measure 

and are proposing a more than 80 

percent threshold for Stage 2 of 

meaningful use. Our experience with 

Stage 1 shows performance on this 

measure above 80 percent. 

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’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 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 Certified EHR Technology 

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 

proposed 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. 

Having accurate information on 

height/length (depending on a patient’s 

age), weight, and blood pressure both on 

the current condition of the patient and 

changes over time provide context to a 

large number and great variety of 

clinical decisions. By capturing height, 

weight, and blood pressure in a 

structured format, EHRs can analyze 

and display the information without the 

need for intervention by the provider. 

The calculation of body mass index and 

plotting of growth charts are just two 

examples. The provider need not do 

anything to calculate BMI or plot a 

growth chart if height and weight are 

recorded as structured data because this 

functionality is included within 

Certified EHR Technology. Similarly, 

information on blood pressure provides 

many opportunities for clinical decision 

support and the identification of patient 

education materials. Again, these 

automated processes can be enabled 

within Certified EHR Technology 

simply by recording blood pressure as 

structured data. 

We propose to continue our policy 

from Stage 1 that height/length, weight, 

and blood pressure do not each need to 

be updated by a provider at every 

patient encounter nor even once per 

patient seen during the EHR reporting 

period. For this objective, we are 

primarily concerned that some 

information is available to the EP, 

eligible hospital or CAH, who can then 

make the determination based on the 

patient’s individual circumstances as to 

whether height/length, weight, and 

blood pressure need to be updated. The 

information can get into the patient’s 

medical record as structured data in a 

number of ways. Some examples 

include entry by the EP, eligible 

hospital, or CAH, entry by someone on 

the EP, eligible hospital, or CAH’s staff, 

transfer of the information electronically 

or otherwise from another provider, or 

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 hospital to 

determine what level of accuracy is 

needed for them to provide care to the 

patient and how best to obtain this 

information. Any method of obtaining 

height, weight or blood pressure is 

acceptable for purposes of this objective 

as long as the information is recorded as 

structured data. 

We have received continuous 

feedback during Stage 1 of meaningful 

use on the appropriate age for collecting 

these vital signs. In particular, we have 

heard from numerous health care 

professionals and associations and the 

HIT Policy Committee recommended 

that height/length and weight should 

not be age-limited and that the limit for 

blood pressure should be raised to 3 

years of age and older in order to align 

with guidelines and recommendations 

from other health care associations. We 

agree with this alignment and propose 

to remove the height/length and weight 

age limits and raise the blood pressure 

limit to 3 years of age and older, but we 

encourage public comment on the age 

limitations of vital signs. Age is 

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determined based on the date when the 

patient is last seen by the EP or 

admitted to the inpatient or emergency 

department of the hospital during the 

EHR reporting period. 

Because we propose to remove the age 

restrictions on recording height/length 

and weight, we also propose to remove 

the age restrictions on calculating and 

displaying BMI and growth charts. 

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 included two exclusions for EPs 

for this measure in Stage 1 of 

meaningful use. The first is that EPs 

who do not see any patients 2 years old 

or older (proposed to be raised to 3 

years old or older optionally in 2013 

and permanently in 2014) are excluded 

from recording blood pressure. The 

second is for EPs who believe that all 3 

vital signs of height/length, weight, and 

blood pressure have no relevance to 

their scope of practice. We received 

considerable feedback on Stage 1 that 

many EPs believe that while they may 

collect weight and blood pressure, they 

do not believe height/length is relevant 

to their scope of practice, or that blood 

pressure is relevant, but not height/ 

length and weight, or some other 

combination. 

Weight without height/length is not 

useful from a record keeping 

perspective. A 225 pound man who is 

5′5′′ has different considerations than a 

225 pound man who is 6′5′′ . Therefore, 

we propose to keep the recording of 

height/length and weight as linked 

requirements. We believe there are 

situations where height/length and 

weight may be relevant, but blood 

pressure is not. We are less certain that 

there would be cases where blood 

pressure is relevant, but height/length 

and weight are not. We propose for 

Stage 2 to split the exclusion so that an 

EP can choose to record height/length 

and weight only and exclude blood 

pressure or record blood pressure only 

and exclude height/length and weight. 

We encourage comments on this split 

and whether it should or should not go 

both ways. 

For Stage 1 of meaningful use, we 

adopted a measure of 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) 

have vital signs recorded as structured 

data. We agree with the HIT Policy 

Committee recommendation to increase 

the threshold of this measure and are 

proposing a more than 80 percent 

threshold for Stage 2 of meaningful use. 

Our preliminary Stage 1 data shows that 

the recording of vital signs far exceeded 

the measure threshold of more than 50 

percent, so we are proposing a threshold 

of 80 percent for this measure for Stage 

2 of meaningful use. We will continue 

to monitor this Stage 1 data as we solicit 

public comment so that we can 

determine if the more than 80 percent 

threshold is appropriate for this 

measure. 

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’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 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. 

An 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. 

An 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. 

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 do not 

propose rules on who may record 

smoking status or how often the record 

should be updated. 

For Stage 2, we propose to limit this 

measure to those patients 13 years old 

and older (as we did in Stage 1). We 

have not observed any significant 

consensus around when it is 

appropriate to collect smoking status, 

regardless of the presence or absence of 

other risk factors. If commenters 

disagree with our age limitation, we 

encourage them to include their reasons 

for disagreement and any evidence that 

may be available as to improved 

consensus among healthcare providers 

on what age limit is appropriate. 

In Stage 1 of meaningful use, we 

considered whether to expand the 

collection of information from smoking 

status to other forms of tobacco use. We 

continue to believe that there are 

insufficient electronic standards for 

collecting information on other types of 

tobacco use and that situations where a 

patient might use multiple types of 

tobacco would damage the standardized 

collection of smoking data, but we 

request comment on whether this is the 

case. 

Finally, in Stage 1 of meaningful use, 

we considered whether to include 

second hand smoke information as part 

of this objective. We continue to believe 

that the level of complexity in 

introducing this requirement is beyond 

a reasonable expectation of meaningful 

use at this time. We believe it would be 

difficult to define what constitutes a 

level of exposure to trigger recording 

second hand smoke information. We 

encourage commenters to submit 

information to us that demonstrates 

consensus and/or standards around the 

collection of second hand smoking data 

that would provide the basis on which 

to create an additional tobacco-related 

measure that is applicable to all EPs and 

hospitals. 

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 Stage 1 of meaningful use, we 

adopted a measure of more than 50 

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) have smoking status 

recorded as structured data. As we 

discussed in the Stage 1 final rule (75 

FR 44344), there were many concerns by 

commenters over the appropriate age at 

which to inquire about smoking status. 

There were also considerable 

differences among commenters as to 

what the appropriate inquiry was and 

what it should have included. Because 

of these comments, we adopted 50 

percent as the measure of this objective. 

The HIT Policy Committee 

recommended an increase in the 

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threshold of this measure from more 

than 50 percent to more than 80 percent. 

Our preliminary Stage 1 data shows that 

the recording of smoking status far 

exceeded the measure threshold of more 

than 50 percent, so we are proposing a 

threshold of 80 percent for this measure 

for Stage 2 of meaningful use. We will 

continue to monitor this Stage 1 data as 

we solicit public comment so that we 

can determine if the more than 80 

percent threshold is appropriate for this 

measure. 

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. 

Replaced EP Objective: Report 

ambulatory clinical quality measures to 

CMS or, in the case of Medicaid EPs, the 

States. 

Replaced Eligible Hospital/CAH 

Objective: Report hospital clinical 

quality measures to CMS or, in the case 

of Medicaid eligible hospitals, the 

States. 

In addition to the meaningful use core 

and menu objectives, EPs and hospitals 

are still required to report clinical 

quality measures to CMS or the States 

in order to demonstrate meaningful use 

of Certified EHR Technology. However, 

we propose to eliminate these objectives 

under 42 CFR 495.6 and instead include 

the reporting of clinical quality 

measures (CQMs) as part of the 

definition of ‘‘meaningful EHR user’’ 

under 42 CFR 495.4. For more 

information about the requirements for 

reporting clinical quality measures, see 

section II.B.3. of this proposed rule. As 

explained in that section, we are 

proposing to move to electronic 

reporting of clinical quality measure 

information. Because the core and menu 

objectives under § 495.6 are reported 

through attestation, we believe it makes 

more sense to separate the reporting of 

CQMs from the other meaningful use 

objectives and measures for Stage 2. 

Proposed Objective: Use clinical 

decision support to improve 

performance on high-priority health 

conditions. 

Clinical decision support at the point 

of care is an area of health IT in which 

significant evidence exists for its 

substantial positive impact on the 

quality, safety, and efficiency of care 

delivery. In Stage 1, we specified that 

the clinical decision support rule 

should be relevant to the provider’s 

specialty or related to a high clinical 

priority. We purposely used a 

description that would allow a provider 

significant leeway in determining the 

clinical decision support interventions 

that are most relevant to their scope of 

practice and benefit their patients in the 

greatest way. Following the 

recommendations of the HIT Policy 

Committee, we are proposing to modify 

the objective for Stage 2 to using clinical 

decision support to improve 

performance on high-priority health 

conditions. We believe that it is best left 

to the provider’s clinical discretion to 

determine which clinical decision 

support interventions would address 

high-priority conditions for their 

individual patient populations, but we 

are requiring as a measure of this 

objective that the clinical decision 

support intervention be related to 5 or 

more of the clinical quality measures on 

which EPs or hospitals would be 

expected to report. We define ‘‘related’’ 

to mean that the intervention’s intent is 

to improve the performance of the EP, 

eligible hospital, or CAH on a given 

clinical quality measure. Because 

clinical quality measures focus on highpriority health conditions by definition, 

this alignment will ensure that clinical 

decision support is also focused on 

high-priority health conditions and 

improved performance in measurable 

quality areas. 

For Stage 2, we are also proposing to 

make the Stage 1 objective for 

‘‘Implement drug-drug and drug-allergy 

checks’’ one of the measures of this 

clinical decision support objective. We 

continue to believe that automated drugdrug 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 believe it 

is appropriate to include this 

functionality as part of this objective for 

using clinical decision support. Finally, 

we have replaced the term ‘‘clinical 

decision support rule’’ used in our Stage 

1 rule with the term ‘‘clinical decision 

support intervention’’ to better align 

with, and clearly allow for, the variety 

of decision support mechanisms 

available to help improve clinical 

performance and outcomes. This 

mirrors an identical change in the ONC 

Standards and Certification proposed 

rule. 

Proposed Measures: EPs, eligible 

hospitals, and CAHs must satisfy both 

measures in order to meet the objective: 

1. Implement 5 clinical decision 

support interventions related to 5 or 

more clinical quality measures at a 

relevant point in patient care for the 

entire EHR reporting period. 

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. 

The drug-drug and drug-allergy 

checks and the implementation of 5 

clinical decision support interventions 

are separate measures for this objective. 

Therefore the EP or hospital must 

implement clinical decision support 

interventions in addition to drug-drug 

and drug-allergy interaction checks. 

For Stage 2 based on the HIT Policy 

Committee recommendations, each 

clinical decision support intervention 

must enable the provider to review all 

of the following attributes of the 

intervention: Developer of the 

intervention, bibliographic citation, 

funding source of the intervention, and 

release/revision date of the intervention. 

This will enable providers to review 

complete information including any 

potential conflict of interest for the 

decision support intervention(s), if they 

so choose. Certified EHR technology 

will display these attributes allowing 

providers to review them. Such 

information may be valuable so that 

providers can understand whether the 

clinical evidence that the intervention 

represents is current, and whether the 

development of that intervention was 

sponsored by an organization that may 

have conflicting business interests 

including, but not limited to, a 

pharmaceutical company, pharmacy 

benefits management company, or 

device manufacturer. We believe that 

there may be cases in which such 

organizations will have interest in 

sponsoring clinical decision support 

interventions, and such interventions 

may very well be in the patient’s best 

interest. Nonetheless, such sponsorship 

should be made transparent to the 

provider using the system. 

In addition to the review of clinical 

decision support attributes, providers 

must implement the clinical decision 

support intervention at a relevant point 

in patient care when the intervention 

can influence clinical decision making 

before an action is taken on behalf of the 

patient. Although we leave it to the 

provider’s clinical discretion to 

determine the relevant point in patient 

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care when such interventions will be 

most effective, the interventions must be 

presented through Certified EHR 

Technology to a licensed healthcare 

professional who can exercise clinical 

judgment about the decision support 

intervention before an action is taken on 

behalf of the patient. 

Finally, we propose that clinical 

decision support intervention must be 

related to 5 or more of the clinical 

quality measures that we will finalize 

for EPs and hospitals and on which they 

will be expected to report. By relating 

clinical decision support interventions 

to one or more clinical quality 

measures, providers are necessarily 

focusing on high-priority health 

conditions, as required by the objective 

and recommended by the HIT Policy 

Committee. Providers would implement 

5 clinical decision support interventions 

that they believe will result in 

improvement in performance for 5 or 

more of the clinical quality measures on 

which they report. For example, EPs 

reporting on the clinical quality 

measure of ‘‘Preventive Care and 

Screening: Influenza Immunization for 

Patients 50 Years Old or Older’’ (NQF 

0041, PQRI 110) could choose to 

implement a clinical decision support 

intervention that triggers an alert in 

Certified EHR Technology prompting a 

licensed healthcare professional to ask 

about influenza immunizations 

whenever a patient 50 years old or older 

presents for an office visit or other 

action that increases the likelihood that 

the patient receives an influenza 

immunization. 

Please note that for Stage 2, we do not 

propose to require the provider to 

demonstrate actual improvement in 

performance on clinical quality 

measures. Rather, the provider must use 

the goal of improvement in performance 

for a clinical quality measure when the 

provider selects a clinical decision 

support intervention to implement. 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. 

We do not believe that any EP, 

eligible hospital, or CAH would be in a 

situation where they could not 

implement five clinical decision 

support intervention as previously 

described. Therefore, we do not propose 

any exclusions for this objective and its 

associated measure. 

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 are not proposing 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. The HIT Policy 

Committee recommended that these 

objectives be combined with objectives 

for online viewing and downloading. 

We agree with the HIT Policy 

Committee and are replacing these Stage 

1 objectives with proposed objectives 

and measures for Stage 2 that would 

enable patients to view online and 

download their health information and 

hospital admission information 

(discussed later in this rule). We believe 

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. 

Proposed EP Objective: Provide 

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. 

We also note 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. 

Proposed EP Measure: Clinical 

summaries provided to patients within 

24 hours for more than 50 percent of 

office visits. 

Following the recommendation of the 

HIT Policy Committee, we propose to 

continue the 50 percent threshold from 

Stage 1. Although many EPs provide 

paper summaries as the patient leaves 

the office, we believe that a timeframe 

is still needed for those EPs who 

provide electronic summaries either as 

the provider’s preferred method of 

distribution or to accommodate patient 

requests for electronic summaries. 

Because the clinical summary is 

intended to be a summary of clinical 

information relevant to an office visit, 

we agree with the HIT Policy Committee 

that 24 hours is a sufficient timeframe 

in which to provide this summary. We 

note that the vast majority of 

information required in the clinical 

summary should be immediately 

available upon completion of the office 

visit. Although we provided 3 business 

days to send the clinical summary in 

Stage 1, we now believe that a faster 

exchange of information with patient is 

not only possible but also encourages 

better quality of care. However, we 

welcome comments on this timeframe. 

As in Stage 1, if a paper summary is 

mailed to the patient, the timeframe 

relates to when the summary is mailed 

and not when it is received by the 

patient. 

Summaries of an office visit 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 results. 

When such information becomes 

available, the HIT Policy Committee 

recommended that the EP have 4 

business days to make the information 

known to the patient. We concur that 

EPs should make this information 

known to the patient, but do not believe 

that a new clinical summary must be 

issued in every instance. For example, 

current common practice is for 

laboratory results to be delivered by 

phone. We are proposing another 

objective of meaningful use that would 

provide for online access to the latest 

health information, whereas this clinical 

summary objective focuses on a singular 

visit. We also are concerned with the 

practicality of measuring this aspect and 

cannot determine how we would assign 

a denominator to it. The EHR would 

have to be capable of recognizing that 

additional information is available, link 

such information to a specific office 

visit, time the provision of information 

to the patient, and create a record that 

the patient was notified. We believe that 

this is too burdensome. The clinical 

summary would include information on 

pending tests, and therefore, will alert 

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patients that more information may 

soon be available if necessary. 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 is 

provided a clinical summary of their 

visit within 24 hours. 

• 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. 

We propose to require the following 

information 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 and any 

updates to it. 

• Current medication list and any 

updates to it. 

• Current medication allergy list and 

any updates to it. 

• Procedures performed during the 

visit. 

• Immunizations or medications 

administered during the visit. 

• Vital signs and any updates. 

• Laboratory test results. 

• List of diagnostic tests pending. 

• Clinical instructions. 

• Future appointments. 

• Referrals to other providers. 

• Future scheduled tests. 

• Demographics maintained by EP 

(gender, race, ethnicity, date of birth, 

preferred language). (New requirement 

for Stage 2.) 

• Smoking status (New requirement 

for Stage 2.) 

• Care plan field, including goals and 

instructions. (New requirement for Stage 

2.) 

• Recommended patient decision aids 

(if applicable to the visit). (New 

requirement for Stage 2.) 

This is not intended to limit the 

information made available in the 

clinical summary by the EP. An EP can 

make available additional information 

and still meet the objective. The content 

of the care plan is dependent on the 

clinical context. We propose to describe 

a care plan as the structure used to 

define the management actions for the 

various conditions, problems, or issues. 

For purposes of meaningful use 

measurement, we propose that 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). 

We encourage EPs to develop the 

most robust care plan that is warranted 

by the situation. We also welcome 

comments on both our description of a 

care plan and whether a description is 

necessary for purpose of meaningful 

use. When an office visit lasts for 

several consecutive days and/or the 

patient is seen by multiple EPs during 

one office visit, a single consolidated 

summary at the end of the visit meets 

this objective. An example of a multiday 

office visit could be an evaluation one 

day, a diagnostic test the next and a 

follow-up treatment the next day based 

on the results of the test. Even in cases 

where multiple office visits occur under 

a global or bundled claim/fee, each visit 

results in an update to the status of the 

health of the patient and must be 

accompanied with a clinical summary. 

We would also maintain several other 

policies from Stage 1. For purposes of 

meaningful use, an EP may withhold 

information from the clinical summary 

if they believe substantial harm may 

arise from its disclosure through an 

after-visit clinical summary. 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 can 

select any modality (for example, 

online, CD, USB) as their electronic 

option and does not have to 

accommodate requests for different 

modalities. We do not believe it would 

be appropriate for an EP to charge the 

patient a fee for providing the summary. 

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. 

Removed Objective: Capability to 

exchange key clinical information. 

In Stage 2, we propose 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 believe that this 

actual use case is more beneficial and 

easier to understand. We also propose to 

remove this objective for Stage 1 as well, 

but consider other option. Please refer to 

the section titled ‘‘Changes to Stage 1’’ 

for details of the options considered. As 

we propose that the EHR reporting 

period for Stage 2 of meaningful use is 

the entire year, a prudent provider 

would 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 Certified EHR 

Technology through the implementation 

of appropriate technical capabilities. 

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. 

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. 

This measure is the same as in Stage 

1 except that we specifically address the 

encryption/security of data that is stored 

in Certified EHR Technology (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 do not propose to change 

the HIPAA Security Rule requirements, 

or require any more than would be 

required under HIPAA. We only 

emphasize the importance of an EP or 

hospital including in its security risk 

analysis an assessment of the 

reasonableness and appropriateness of 

encrypting electronic protected health 

information as a means of securing it, 

and where it is not reasonable and 

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appropriate, the adoption of an 

equivalent alternative measure. 

We propose this measure because the 

implementation of Certified EHR 

Technology 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. 

We emphasize 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. 

(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 

propose 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 would remain 

in the menu set for Stage 2. As 

discussed later, we also propose to 

modify and combine some of these 

objectives and associated measures for 

Stage 2. 

Consolidated Objective: Implement 

drug formulary checks. 

For Stage 2, we are proposing 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. 

Proposed Objective: Incorporate 

clinical lab-test results into Certified 

EHR Technology as structured data. 

We believe that incorporating clinical 

lab-test results into Certified EHR 

Technology as structured data assists in 

the exchange of complete information 

between providers of care, facilitates the 

sharing of information with patients and 

their designated representatives, and 

contributes to the improvement of 

health care delivery to the patient. We 

encourage every EP, eligible hospital, 

and CAH to utilize electronic exchange 

of results with laboratories in 

accordance with the certification criteria 

in the ONC standards and certification 

proposed rule published elsewhere in 

this issue of the Federal Register. If 

results are not received through 

electronic exchange, then they are 

presumably received in another form 

(such as by fax, telephone call, mail) 

and would need to be incorporated into 

the patient’s medical record in some 

way. We encourage the recording of 

results as structured data; however, 

there would be risk of recording the data 

twice (for example, scanning the faxed 

results and then entering the results as 

structured data). To reduce the risk of 

entry error, we highly encourage the 

electronic exchange of the results with 

the laboratory, instead of manual entry 

through typing, option selecting, 

scanning or other means. 

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 

Certified EHR Technology as structured 

data. 

Although the HIT Policy Committee 

did not recommend an increase in the 

threshold for this measure, our initial 

data on Stage 1 of meaningful use shows 

high compliance with this measure for 

those providers individually selecting 

the objective from the menu set. 

Therefore we are proposing to increase 

the threshold of this objective to 55 

percent for Stage 2. 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

• 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 whose results are expressed in a 

positive or negative affirmation or as a 

number which are incorporated in 

Certified EHR Technology 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 whose results are either in a 

positive/negative 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. 

Reducing the risk of entry error is one 

of the primary reasons we lowered the 

measure threshold to 40 percent for 

Stage 1, during which providers are 

changing their workflow processes to 

accurately incorporate information into 

EHRs through either electronic 

exchange or manual entry. However, for 

this measure, we do not limit the EP, 

eligible hospital or CAH to only 

counting structured data received via 

electronic exchange, but count in the 

numerator all structured data. By 

entering these results into the patient’s 

medical record as structured data, the 

EP, eligible hospital or CAH is 

accomplishing a task that must be 

performed regardless of whether the 

provider is attempting to demonstrate 

meaningful use or not. We believe that 

entering the data as structured data 

encourages future exchange of 

information. We have received inquiries 

on Stage 1 on how to account for 

laboratory tests that are ordered in a 

group or panel. The inquiries have 

highlighted several problems this 

creates for measurement (for example, 

EHR only counting a panel as one, but 

the results individually creating more 

than 100 percent performance, panels 

that include tests that are included in 

the measure and other tests that are not 

included in the measure, EHRs that 

count the entire panel if one test meets 

the numerator criteria). The measure in 

Stage 1 and Stage 2 counts lab tests 

individually, not as panels or groups in 

both the numerator and the 

denominator for the very complications 

illustrated by the inquiries that occur 

when this is not done. However, we 

solicit comment on whether such 

individual accounting is infeasible. We 

note that this in no way precludes the 

use of grouping and panels when 

ordering labs. While we are not 

proposing to move beyond numeric and 

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13718 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 

1 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 

would 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 would 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. 

2The 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 2 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. 

yes/no tests, we request comments on 

whether standards and other 

capabilities would allow us to expand 

the measure to all quantitative results 

(all results that can be compared on as 

a ratio or on a difference scale). 

Proposed Objective: Generate lists of 

patients by specific conditions to use for 

quality improvement, reduction of 

disparities, research, or outreach. 

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 would use 

these reports in combination with one of 

the 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 proposed rule published 

elsewhere in this issue of the Federal 

Register; not all capabilities and 

variables must be used for every list. 

Proposed Measure: Generate at least 

one report listing patients of the EP, 

eligible hospital, or CAH with a specific 

condition. 

We propose 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 do 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 are also 

seeking comment on whether a measure 

that either increases the number and/or 

frequency of the patient lists would 

further the intent of this objective. 

Proposed EP Objective: Use clinically 

relevant information to identify patients 

who should receive reminders for 

preventive/follow-up care. 

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. 

In Stage 1, this objective was stated as 

‘‘Send reminders to patients per patient 

preference for preventive/follow-up 

care.’’ For Stage 2, the HIT Policy 

Committee recommended that clinically 

relevant information from Certified EHR 

Technology be used to identify patients 

to whom reminders of preventive/ 

follow-up care would be most 

beneficial. We agree with this 

recommendation and are proposing to 

modify this objective for Stage 2 as ‘‘Use 

clinically relevant information to 

identify patients who should receive 

reminders for preventive/follow-up 

care.’’ An EP should use clinically 

relevant information stored within the 

Certified EHR Technology 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. 

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 propose 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 

encourage 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 are proposing 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. 

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 an office visit 

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 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. 

The goal of this objective is 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, 

this objective aligns with the Fair 

Information Practice Principles (FIPPs),1

in affording baseline privacy protections 

to individuals.2 In particular, the 

principles include Individual Access 

(patients should be provided with a 

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simple and timely means to access and 

obtain their individually identifiable 

information in a readable form and 

format). 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 agree 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, the patient must be able 

to access this information on demand, 

such as through a patient portal or 

personal health record (PHR). 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. 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. 

In the Stage 1 final rule (75 FR 44356), 

we indicated that information should be 

available to the patient through online 

access within 4 business days of the 

information being available to the EP 

through either the receipt of final lab 

results or a patient encounter that 

updates the EP’s knowledge of the 

patient’s health. For Stage 2, we propose 

to maintain the requirement of 

information being made available to the 

patient through online access within 4 

business days of the information being 

available to the EP. To that end, we 

propose to continue the definition of 

business days as Monday through 

Friday excluding Federal or State 

holidays on which the EP or their 

administrative staff are unavailable. The 

HIT Policy Committee recommended 

that EPs be required to make 

information resulting from a patient 

encounter available within 24 hours 

instead of 4 business days. They also 

recommended continuing the 4 business 

day timeframe for updates following the 

receipt of new information. We believe 

that splitting the timeframes in this 

manner adds unnecessary complexity to 

this objective and associated measure. 

We believe that 4 business days remains 

a reasonable timeframe and limits the 

needs for updating. To the extent that 

Certified EHR Technologies enable a 

quicker posting time we expect that this 

will be workflow benefit to the 

providers and they will utilize this 

quicker time regardless of the threshold 

timeline in meaningful use. 

Proposed EP Measures: We propose 2 

measures for this objective, both of 

which must be satisfied in order to meet 

the objective: 

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 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. 

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 would be a 

download. 

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 

online. 

• Threshold: The resulting percentage 

must be more than 50 percent in order 

for an EP to meet this measure. 

To calculate the percentage of the 

second measure for patients or patientauthorized representatives to 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 or downloaded or 

transmitted to a third party the patient’s 

health information. 

• Threshold: The resulting percentage 

must be more than 10 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 this measure 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 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. 

The thresholds of both of these 

measures must be reached in order for 

the EP to meet the objective. If the EP 

reaches one of these thresholds but not 

the other, then the EP will fail to meet 

this objective, unless the EP meets an 

applicable exclusion. An EP that 

conducts the 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 the 

second measure. According to the FCC 

at the time of formulation of this 

proposed rule, 370 counties in the 

United States have broadband 

penetration of less than 50 percent 

(www.broadband.gov). Further 

discussion of this exclusion can be 

found under the eligible hospital and 

CAH objective of ‘‘Provide patients the 

ability to view online, download, and 

transmit information about a hospital 

admission.’’ We are also proposing that 

an EP who neither orders nor creates 

any of the information listed for 

inclusion as part of these measures may 

exclude both the first and second 

measures. 

Consistent with the recommendations 

of the HIT Policy Committee, we are 

proposing a threshold of more than 10 

percent for patients (or their authorized 

representatives) to view, download or 

transmit to a third party health 

information. An EP has any number of 

ways to make this information available 

online. The EP can host a patient portal, 

contract with a vendor to host a patient 

portal, connect with an online PHR or 

other means. As long as the patient can 

view, download, and transmit the 

information using a standard web 

browser and internet connection, the 

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means is at the discretion of the EP. We 

note that this new measure does not 

focus solely on access and instead 

requires action by patients or their 

authorized representatives in order for 

the EP to meet it. A patient who views 

their information online, downloads it 

from the internet or uses the internet to 

transmit it to a third party would count 

for purposes of the numerator. While 

this is a departure from most 

meaningful use measures, which are 

dependent solely on actions taken by 

the EP, we believe that requiring a 

measurement of patient use ensures that 

the EP will promote the availability and 

active use of electronic health 

information by the patient or their 

authorized representatives. 

Furthermore, we believe that 

accountable care should extend to 

meaningful use objectives that 

encourage patient and family 

engagement. We invite comment on this 

new measure and whether the 10 

percent threshold is too high or too low 

given the patient’s role in achieving it. 

We define patient-authorized 

representative as any individual to 

whom the patient has granted access to 

their health information. Examples 

would include family members, an 

advocate for the patient, or other 

individual identified by the patient. A 

patient would have to affirmatively 

grant access to these representatives 

with the exception of minors for whom 

existing local, State or Federal law 

grants their parents or guardians access 

without the need for the minor to 

consent and individuals who are unable 

to provide consent and where the State 

appoints a guardian. 

In order to make the information 

available to patients online consistent 

with the information provided during 

transitions of care, we are aligning the 

information required to meet this 

objective with the information provided 

in the summary of care record for each 

transition of care or referral. Therefore, 

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. 

• Problem list. 

• Procedures. 

• Laboratory test results. 

• Medication list. 

• Medication allergy list. 

• Vital signs (height, weight, blood 

pressure, BMI, growth charts). 

• Smoking status. 

• Demographic information 

(preferred language, gender, race, 

ethnicity, date of birth). 

• Care plan field, including goals and 

instructions, and 

• Any additional known care team 

members beyond the referring or 

transitioning provider and the receiving 

provider. 

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. 

As stated in the Stage 1 final rule (75 

FR 44356), we understand that there 

may be situations where a provider 

decides that online posting is not the 

best forum to communicate results. 

Within the confines of laws governing 

patient access to their medical records, 

we defer to an EP’s judgment as to 

whether to hold information back in 

anticipation of an actual encounter or 

conversation between the EP or a 

member of their staff and the patient. 

Furthermore, for purposes of meeting 

this objective, an EP may withhold 

information from being accessible 

electronically if its disclosure would 

cause substantial harm to the patient or 

another individual. Therefore, if in the 

EP’s judgment substantial harm may 

arise from the disclosure of particular 

information, an EP may choose to 

withhold that particular information. 

Any such withholding would not affect 

the EP’s ability to meet this measure as 

that information would not be included 

in the percentage calculation. However, 

we note that such withholding of 

information would not have any effect 

on a provider’s obligations under 45 

CFR 164.524 when an individual 

exercises his or her right of access to 

inspect and obtain a copy of protected 

health information about the individual 

in a designated record set. We do not 

believe there would be a circumstance 

where all information about an 

encounter would be withheld from the 

patient and therefore some information 

would be eligible for uploading for 

online access. If nothing else, 

information that the encounter occurred 

should be provided. This is a 

meaningful use provision, which does 

not override applicable federal, State or 

local laws regarding patient access to 

health information, including the 

requirements under the HIPAA Privacy 

Rule at 45 CFR 164.524. 

As discussed earlier in this proposed 

rule, beginning in 2014, Certified EHR 

Technology will no longer be certified 

for the Stage 1 objectives of providing 

patients with an electronic copy of their 

health information upon request and 

providing patients with timely 

electronic access to their health 

information. This new ‘‘view and 

download’’ objective would replace 

those objectives, and we are proposing 

to include it in the core set for Stages 

1 and 2 beginning in 2014.’’ However, 

for Stage 1, we are only proposing the 

first measure of ‘‘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.’’ Both 

measures would be required for Stage 2. 

Proposed Objective: Use clinically 

relevant information from Certified EHR 

Technology to identify patient-specific 

education resources and provide those 

resources to the patient. 

Providing clinically relevant 

education resources to patients is a 

priority for the meaningful use of 

Certified EHR Technology. Because of 

our experience with this objective in 

Stage 1, we are clarifying that while 

Certified EHR Technology must be used 

to identify patient-specific education 

resources, these resources or materials 

do not have to be stored within or 

generated by the Certified EHR 

Technology. 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 

Certified EHR Technology (that is, 

specific patient characteristics are 

linked to specific consumer health 

content). The EP or hospital should 

utilize Certified EHR Technology in a 

manner where the technology suggests 

patient-specific educational resources 

based on the information stored in the 

Certified EHR Technology. 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 

Certified EHR Technology 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). 

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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 are proposing to remove 

the phrase ‘‘if appropriate’’ from the 

objective for Stage 2 because we do not 

believe that any EP or hospital would 

have difficulty identifying appropriate 

patient-specific education resources for 

the low percentage of patients required 

by the measure of this objective. 

We also recognize 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 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. We are specifically inviting 

comments and seeking input on 

whether EPs and hospitals believe that 

patient-specific education resources at 

appropriate literacy levels and with 

appropriate cultural competencies could 

be successfully identified at this time 

through the use of Certified EHR 

Technology. 

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 Stage 1, the measure of 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 are 

proposing this as a core objective for 

Stage 2, we have modified the measure 

for EPs to ‘‘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.’’ We recognize that some EPs 

may not conduct face-to-face 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 are proposing to 

alter the measure to account for office 

visits rather than unique patients seen 

by the EP. We are also proposing an 

exclusion for EPs who have no office 

visits in order to accommodate such 

EPs. The resources would have to be 

those identified by CEHRT. If resources 

are not identified by CEHRT and 

provided to the patient then it would 

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 set the threshold at only ten 

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 

would need to be provided prior to the 

calculation and subsequent attestation 

to meaningful use. 

To calculate the percentage for EPs, 

CMS and ONC have worked together to 

define the following for this objective: 

• Denominator: Number of office 

visits by the EP during the EHR 

reporting period. 

• Numerator: Number of patients who 

had office visits during the EHR 

reporting period who were subsequently 

provided patient-specific education 

resources identified by 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. 

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 Certified EHR 

Technology. 

• Threshold: The resulting percentage 

must be more than 10 percent in order 

for an eligible hospital or CAH to meet 

this measure. 

Our explanation of ‘‘patient-specific 

education resources identified by 

Certified EHR Technology’’ for the EP 

measure also applies for the hospital 

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. 

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. 

We note 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. It is for 

the receiving provider that up-to-date 

medication information will be most 

crucial in order to make informed 

clinical judgments for patient care. We 

reiterate 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. 

For the purposes of this objective, we 

propose to maintain the definition of a 

transition of care as the movement of a 

patient from one setting of care (for 

example, a hospital, ambulatory primary 

care practice, ambulatory specialty care 

practice, long-term care, home health, 

rehabilitation facility) to another. 

For Stage 2, we also propose to 

maintain the definition of 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. There are additional 

resources available that further define 

medication reconciliation that while not 

incorporated into meaningful use may 

be helpful for EPs, eligible hospitals, 

and CAHs. While we believe that an 

electronic exchange of information 

following the transition of care of a 

patient is the most efficient method of 

performing medication reconciliation, 

we also realize it is unlikely that an 

automated process within the EHR will 

fully supplant the medication 

reconciliation conducted between the 

provider and the patient. Therefore, the 

electronic exchange of information is 

not a requirement for medication 

reconciliation. 

While the objective is to conduct 

medication reconciliation at all relevant 

encounters, determining which 

encounters are relevant beyond 

transitions of care is too subjective to be 

included in the measure. 

Proposed Measure: The EP, eligible 

hospital or CAH performs medication 

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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). 

The HIT Policy Committee 

recommended maintaining this 

threshold at 50 percent. However, 

because this measure relates directly to 

the role of information exchange that we 

seek to promote through the meaningful 

use of Certified EHR Technology, we 

believe that a higher threshold for this 

measure is appropriate. Although the 

majority chose to defer this measure in 

Stage 1, the performance of both EPs 

and hospitals was well above the Stage 

1 threshold. For these reasons we are 

proposing to raise the threshold of this 

measure to 65 percent for Stage 2. 

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 65 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. 

By guaranteeing 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. 

The feedback we have received from 

providers who have met Stage 1 

meaningful use requirements has 

convinced us that the exchange of key 

clinical information is most efficiently 

accomplished within the context of 

providing a summary of care record 

during transitions of care. Therefore, we 

are proposing to eliminate the 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. 

In addition the HIT Policy Committee 

made two separate Stage 2 

recommendations for EPs, eligible 

hospitals, and CAHs to record 

additional information— 

• 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. 

We believe that this information is 

best incorporated as required data 

within the summary of care record 

itself. Rather than implement two 

separate objectives and measures for 

these recommendations, we are 

establishing these as required fields 

along with the summary of care 

information listed later. The ONC 

proposed rule on standards and 

certification includes these as standard 

fields required to populate the summary 

of care document so Certified EHR 

Technology would be able to include 

this information. We also recognize that 

a ‘‘care plan’’ may require further 

definition. The content of the care plan 

is dependent on the clinical context. We 

propose to describe a care plan as the 

structure used to define the 

management actions for the various 

conditions, problems, or issues. For 

purposes of meaningful use 

measurement we propose that 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). 

We encourage EPs to develop the 

most robust care plan that is warranted 

by the situation. We also welcome 

comments on both our description of a 

care plan and whether a description is 

necessary for purpose of meaningful 

use. 

All summary of care documents used 

to meet this objective must include the 

following: 

• Patient name. 

• Referring or transitioning provider’s 

name and office contact information (EP 

only). 

• Procedures. 

• Relevant past diagnoses. 

• Laboratory test results. 

• Vital signs (height, weight, blood 

pressure, BMI, growth charts). 

• Smoking status. 

• Demographic information 

(preferred language, gender, race, 

ethnicity, date of birth). 

• Care plan field, including goals and 

instructions, and 

• Any additional known care team 

members beyond the referring or 

transitioning provider and the receiving 

provider. 

In addition, eligible hospitals and 

CAHs would be required to include 

discharge instructions. 

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: 

• An up-to-date problem list of 

current and active diagnoses. 

• An active medication list, and 

• An active medication allergy list. 

We encourage all summary of care 

documents to contain the most recent 

and up-to-date information on all 

elements. In order for the summary of 

care document to count in the 

numerator of this objective, the EP or 

hospital must verify these three fields 

for problem list, medication list, and 

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. We define problem list as a 

list of current and active diagnoses. We 

solicit 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 

define an up-to-date problem list as a 

list populated with the most recent 

diagnoses known by the EP or hospital. 

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 

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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. 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.’’ 

We leave it to the provider’s clinical 

judgment to identify any additional 

clinical information that would be 

relevant to include in the summary of 

care record. 

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 Certified EHR 

Technology to a recipient with no 

organizational affiliation and using a 

different Certified EHR Technology 

vendor than the sender for more than 10 

percent of transitions of care and 

referrals. 

• Exclusion: Any EP who neither 

transfers a patient to another setting nor 

refers a patient to another provider 

during the EHR reporting period is 

excluded from both measures. 

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 65 percent in order for an EP, 

eligible hospital, or CAH to meet this 

measure. 

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 Certified 

EHR Technology would have access to 

the same information, so providing a 

clinical care summary for transfers 

within the hospital would not be 

necessary. 

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 electronically transmitted 

using Certified EHR Technology to a 

recipient with no organizational 

affiliation and using a different Certified 

EHR Technology vendor than the 

sender. 

• Threshold: The percentage must be 

more than 10 percent in order for an EP, 

eligible hospital or CAH to meet this 

measure. 

For Stage 2, we are proposing 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 proposed 

2014 Edition EHR certification criteria. 

Please see the ONC proposed rule 

published elsewhere in this issue of the 

Federal Register for more details. 

These protocols will allow every 

provider with certified electronic health 

record technology 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 propose 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 a provider must use Certified 

EHR Technology 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 

Certified EHR Technology 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. 

We acknowledge 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. Thus, 

ONC requests comments on whether 

equivalent alternative transport 

standards exist to the ones ONC 

proposes to exclusively permit for 

certification. Comments on transports 

standards should be made to the ONC 

proposed rule published elsewhere in 

this issue of the Federal Register, while 

comments on the appropriateness of 

limiting this measure to only those 

standards finalized by ONC should be 

made to this rule. Note, 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. The required 

elements and standards of the summary 

of care document will be discussed in 

the ONC standards and certification 

proposed rule published elsewhere in 

this issue of the Federal Register. We 

are considering, in lieu of requiring 

solely the transmission capability and 

transport standard(s) included in a 

provider’s Certified EHR Technology 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 

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through regulation. We request public 

comment on whether this additional 

flexibility should be added to our 

proposed numerator limitations. 

Another potential concern could be 

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 has indicated in its 

proposed rule that it 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 solicit 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 propose 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 Certified EHR Technology from 

the same EHR vendor. 

We propose 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 believe that it is 

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 recognize 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 solicit comment on the 

following concerns stakeholders may 

have relative to the numerator 

limitations we proposed previously. 

We could see 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 that 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 recognize 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 recognize 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 seek 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 

exclusions Certified EHR Technology 

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, and ONC will 

seek comment in their proposed 

certification rule as to the feasibility of 

this reporting requirement for certified 

EHR technologies. 

Despite the possible unintended 

consequences of the parameters we 

propose for the numerator, we believe 

that these limitations will help ensure 

that electronic health information 

exchange proceeds at the pace necessary 

to accomplish the goals of meaningful 

use. We encourage 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. 

However, we note that electronic 

transmittal is not a requirement for the 

first measure to provide a summary of 

care record. For the first measure, where 

the electronic transmittal of the 

summary of care record is not a 

requirement but an option, a provider is 

permitted to generate an electronic or 

paper copy of the summary of care 

record using the Certified EHR 

Technology and to document that it was 

provided to the patient, receiving 

provider or both. In this case, the use of 

physical media such as a CD–ROM, a 

USB or hard drive, or other formats 

could satisfy the measure of this 

objective. 

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. We believe 

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 encourage 

comment on whether there are 

significant barriers in addition to those 

discussed above to EPs meeting the 10 

percent threshold for this measure. 

In addition, the HIT Policy Committee 

recommended maintaining the 50 

percent threshold from Stage 1. 

However, because this measure relates 

directly to the role of information 

exchange that we seek to promote 

through the meaningful use of Certified 

EHR Technology, we believe that a 

higher threshold for this measure is 

appropriate. Although the majority 

chose to defer this measure in Stage 1, 

the performance of both EPs and 

hospitals was well above the Stage 1 

threshold. For these reasons we are 

proposing to raise the threshold of this 

measure to 65 percent for Stage 2. 

The thresholds of both measures must 

be reached in order for the EP, eligible 

hospital, or CAH to meet the objective. 

If the EP, eligible hospital, or CAH 

reaches one of these thresholds but not 

the other, then the EP, eligible hospital, 

or CAH will fail to meet this objective. 

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(c) Public Health Objectives 

Due to similar considerations among 

the public health objectives, we are 

discussing them together. Some Stage 2 

public health objectives are in the core 

set while others are in the menu set. 

Each objective is identified as either 

core or menu in the below 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 

where authorized, 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 are proposing the following 

requirements, which would apply to all 

of the public health objectives and 

measures. We propose that actual 

patient data is required for the 

meaningful use measures that include 

ongoing submission of patient data. 

There are a growing number of public 

health agencies partnering 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 at: 

https://questions.cms.hhs.gov/app/ 

answers/detail/a_id/10764/kw/ 

immunizations) we clarify that such 

arrangements with HIE organizations, if 

serving on the behalf of the public 

health agency 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 Certified EHR 

Technology 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. 

• An eligible provider is required to 

utilize the transport method or methods 

supported by the public health agency 

in order to achieve meaningful use. 

• Unlike in Stage 1, a failed 

submission would not meet the 

objective. An eligible provider must 

either have successful ongoing 

submission or meet exclusion criteria. 

• We expect that CMS, CDC and 

public health agencies (PHA) 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 

request comments on challenges to 

implementing this strategy. 

We will accept a yes/no attestation 

and information indicating to which 

public health agency the public health 

data were submitted to support each of 

the public health meaningful use 

measures. 

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 would not preempt otherwise 

applicable State or local laws that 

govern reporting. In the latter case, EPs, 

eligible hospitals and CAHs would be 

excluded from 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. 

This objective is in the Stage 2 core 

set for EPs, eligible hospitals and CAHs. 

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 

Certified EHR Technology, 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 

propose 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. 

The HIT Policy Committee 

recommended making this a core 

objective for Stage 2 for EPs and 

hospitals, and we are adopting their 

recommendation. We agree that the bar 

for Stage 2 should move from simply 

testing the electronic submission of 

immunization data to ongoing 

submission. We also agree that given the 

focus on upgrading and enhancing 

immunization registries’ capacity, under 

CDC’s guidance, this measure is 

sufficiently achievable to warrant its 

inclusion in the core set of Stage 2 

meaningful use measures. However, we 

specifically invite comment on the 

challenges that moving this objective 

from the menu set to the core set would 

present for EPs and hospitals. 

We also propose to modify the Stage 

1 objective to add ‘‘except where 

prohibited’’ because we want 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 is not required 

by either law or practice. There are a 

few instances where some EPs, eligible 

hospitals, and CAHs are not authorized 

or cannot submit 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). 

Proposed 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. 

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 the 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 

receiving electronic immunization data 

in the specific for Certified EHR 

Technology at the start of their EHR 

reporting period; or (3) the EP, eligible 

hospital or CAH operates in a 

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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. For the second 

and third scenarios, there is no 

exclusion if an entity designated by the 

immunization registry can receive 

electronic immunization data 

submissions. For example, if the 

immunization registry cannot accept the 

data directly or in the version of HL7 

used by the provider’s Certified EHR 

Technology, but has designated a Health 

Information Exchange to do so on their 

behalf, the provider could not claim the 

2nd or 3rd exclusions previously noted. 

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. 

This objective is in the Stage 2 core 

set for eligible hospitals and CAHs. The 

same rationale for the 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. 

Proposed Eligible Hospital/CAH 

Measure: Successful ongoing 

submission of electronic reportable 

laboratory results from Certified EHR 

Technology to a public health agency 

for the entire EHR reporting period. 

Please refer to the general public 

health discussion regarding use of 

intermediaries. 

Exclusions: The eligible hospital or 

CAH operates in a jurisdiction for which 

no public health agency is capable of 

receiving electronic reportable 

laboratory results in the specific 

standards required by ONC for EHR 

certification at the start of the EHR 

reporting period. 

Proposed Objective: Capability to 

submit electronic syndromic 

surveillance data to public health 

agencies except where prohibited, and 

in accordance with applicable law and 

practice. 

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 acknowledged 

that our nation’s public health IT 

infrastructure is not universally capable 

of receiving syndromic surveillance data 

from Certified EHR Technology, either 

due to technical or resource readiness. 

Given public health IT infrastructure 

improvements and new implementation 

guidance, for Stage 2, we are proposing 

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 

proposed 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 providers, and there is 

no corresponding implementation guide 

at the time of this proposed rule. CDC 

is working with the syndromic 

surveillance community to develop a 

new implementation guide for 

ambulatory reporting of syndromic 

surveillance information, which it 

expects will be available in the fall of 

2012. 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 are not 

proposing to adopt their 

recommendation for EPs. We 

specifically invite 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. 

Proposed Measure: Successful 

ongoing submission of electronic 

syndromic surveillance data from 

Certified EHR Technology to a public 

health agency for the entire 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 (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 

would not collect such information); (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 ONC for 

EHR certification for 2014 at the start of 

their EHR reporting period; or (4) the 

EP, eligible hospital, or CAH operates in 

a jurisdiction for which no public health 

agency is capable of accepting the 

specific standards required for Certified 

EHR Technology at the start of their 

EHR reporting period. As was described 

under the immunization registry 

measure, the third and fourth exclusions 

do not apply if the public health agency 

has designated an HIE to collect this 

information on its behalf and that HIE 

can do so in the specific Stage 2 

standards and/or the same standard as 

the provider’s Certified EHR 

Technology. 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 would be 

open at all times. 

(d) New Core and Menu Set Objectives 

and Measures for Stage 2 

We are proposing 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 are proposing 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 these new 

menu set 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 

Certified EHR Technology. 

Making the image that results from 

diagnostic scans and accompanying 

information accessible through Certified 

EHR Technology 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 

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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. 

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 Certified EHR 

Technology, but in absence of such 

exchange it is acceptable to manually 

add the image and accompanying 

information to Certified EHR 

Technology. 

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 

EHR reporting period are accessible 

through Certified EHR Technology. 

For Stage 2, we do 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 

Certified EHR Technology may be 

counted in the numerator of this 

measure. We define accessible as either 

incorporation of the image and 

accompanying information into 

Certified EHR Technology or an 

indication in Certified EHR Technology 

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 Certified 

EHR Technology. Meaningful use does 

not 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 Certified EHR 

Technology. This link must conform to 

the certification requirements associated 

with this objective in the ONC rule. We 

encourage comments on the necessary 

level of specification and what those 

specifications should be to define 

accessible and what constitutes a direct 

link. 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of scans and 

tests whose result is one or more image 

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 Certified EHR Technology. 

• Threshold: The resulting percentage 

must be more than 40 percent in order 

to meet this measure. 

Exclusion: Any EP who does not 

perform diagnostic interpretation of 

scans or tests whose result is an image 

during the EHR reporting period. 

We also solicit comments on a 

potential second measure for this 

objective that would encourage the 

exchange of imaging and results 

between providers. We are considering 

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 Certified 

EHR Technology also be exchanged 

with another provider of care. However, 

we are concerned that this extra 

measure may be difficult for some EPs 

to meet and might discourage a 

significant number of EPs from selecting 

this objective as part of their menu set. 

We also solicit comment on whether an 

exclusion for this second measure 

should be included for providers who 

do not typically exchange imaging scans 

and test results as a normal part of their 

workflow, and we encourage 

commenters to provide details about 

how such an exclusion might be 

included. 

Proposed Objective: Record patient 

family health history as structured data. 

Family health history is a major risk 

indicator for a variety of chronic 

conditions for which effective screening 

and prevention tools are available. 

Certified EHR technology can use family 

health history, if captured as structured 

data, to inform clinical decision 

support, patient reminders, and patient 

education. Family health history would 

also benefit from greater interoperability 

made possible by EHRs. A family health 

history is unique to each patient and 

fairly static over time. Currently, every 

provider requests this information 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. 

The HIT Policy Committee 

recommended delaying the inclusion of 

this objective until Stage 3 due to 

absence of available standards. 

However, we believe that standards 

supporting family health history are 

currently available. We are proposing 

this as a menu objective for Stage 2. 

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. 

For Stage 2, we do not propose to 

include the capability to exchange 

family health history electronically as 

part of the measure. We do not believe 

there is sufficient structured data 

capture of family health history to 

support such exchange. After Stage 2 

increases the capture of family health 

history in EHRs, we will seek to include 

exchange with other providers and the 

patient in Stage 3. 

We propose 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 note that this is 

a minimum and not a limitation on the 

health history that can be recorded. We 

invite comment on the utility of 

expanding this definition to capture 

risks associated with social and other 

environmental determinants. 

We do 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. 

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. 

We are concerned that certain EPs 

may not be able to meet this measure 

either due to scope of practice 

constraints or lack of patient interaction. 

Therefore, we are proposing an 

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13728 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 

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 would not 

have the face-to-face contact with 

patients necessary to obtain family 

health history information. We also 

believe that EPs who do not have office 

visits may be unable to obtain family 

health history information from 

referring physicians, which could 

prevent them from being able to meet 

the measure of this objective. While the 

exclusion does not relate directly to the 

denominator, it represents the barriers 

justifying the exclusion. Furthermore, 

all office visits would not require 

updates to family health history. 

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. 

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. 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 have 

included this objective to provide more 

flexibility in the menu objectives that 

EPs can choose. We believe that cancer 

reporting could provide many EPs with 

a meaningful use public health 

reporting option that is more aligned 

with their scope of practice. 

We include ‘‘except where prohibited 

and in accordance with applicable law’’ 

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. 

Proposed EP Measure: Successful 

ongoing submission of cancer case 

information from Certified EHR 

Technology to a cancer registry for the 

entire EHR reporting period. 

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; or (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 under Stage 2 at the 

beginning of their EHR reporting period. 

An EP must either successfully 

submit or meet 1 of the exclusion 

criteria. 

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. 

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. 

Proposed EP Measure: Successful 

ongoing submission of specific case 

information from Certified EHR 

Technology to a specialized registry for 

the entire EHR reporting period. 

Exclusions: Any EP that meets at least 

1of 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; or (2) the EP operates in a 

jurisdiction for which no registry is 

capable of receiving electronic specific 

case information in the specific 

standards required under Stage 2 at the 

beginning of their EHR reporting period. 

Proposed EP Objective: Use secure 

electronic messaging to communicate 

with patients on relevant health 

information. 

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 are proposing this as a core 

objective for EPs for Stage 2. The 

additional time made available for Stage 

2 implementation makes possible the 

inclusion of some new objectives in the 

core set. 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 seek comment on whether 

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there may be special concerns with this 

objective in regards to behavioral health. 

Proposed EP Measure: A secure 

message was sent using the electronic 

messaging function of Certified EHR 

Technology by more than 10 percent of 

unique patients seen by the EP during 

the EHR reporting period. 

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 

in the denominator who send a secure 

electronic message to the EP using the 

electronic messaging function of 

Certified EHR Technology 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 no office 

visits during the EHR reporting period. 

We note that this new measure 

requires action by patients in order for 

the EP to meet it. While this is a 

departure from most meaningful use 

measures, which are dependent solely 

on actions taken by the EP, we believe 

that requiring a measurement of patient 

use ensures that the EP will promote the 

availability and active use of secure 

electronic messaging by the patient. 

Furthermore, we believe that 

accountable care should extend to 

accountability for meaningful use 

objectives that encourage patient and 

family engagement. We invite comment 

on this new measure and whether EPs 

believe that the 10 percent threshold is 

too high or too low given the patient’s 

role in achieving it. 

We specify that 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, not because we believe that 

the messages sent by the patient to the 

healthcare provider do not need to 

contain relevant health information, but 

because we believe the provider is best 

equipped to determine whether such 

information is included. It would be too 

great a burden for the certified EHR 

technology, or the attestation process, to 

determine whether the information in 

the secure message has such 

information. We also note that 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 as 

a condition of meeting this measure. 

To address some circumstances 

regarding scope of practice, we propose 

an exclusion to this objective for EPs 

who have no office visits during the 

EHR reporting period. Not having any 

office visits for an entire EHR reporting 

period indicates that there may not be 

a need for follow-up communication 

through secure electronic messaging. 

Proposed Eligible Hospital/CAH 

Objective: Automatically track 

medications from order to 

administration using assistive 

technologies in conjunction with an 

electronic medication administration 

record (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 are proposing 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 in half the 

adverse drug event (ADE) rates for nontiming 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.ama-assn.

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 propose to define eMAR as 

technology that automatically 

documents the administration of 

medication into Certified EHR 

Technology 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 proposed rule 

published elsewhere in this issue of the 

Federal Register. 

By its very definition, eMAR occurs at 

the point of care so we do not propose 

additional qualifications on when it 

must be used or who must use it. 

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. 

This recommendation by the HIT 

Policy Committee was that the measure 

of this objective be that eMAR is 

implemented and in use for the entire 

EHR reporting period in at least one 

ward/unit of the hospital. However, we 

recognize that it may be difficult to 

provide a definition of ward or unit that 

is applicable for all eligible hospitals 

and CAHs. Therefore we are proposing 

a percentage-based measure that would 

be applicable to all medication orders 

created by authorized providers of an 

inpatient or emergency department. We 

believe the low threshold of 10 percent 

allows eligible hospitals and CAHs 

maximum flexibility in how they choose 

to implement eMAR. We note that this 

approach does not prevent an eligible 

hospital or CAH from implementing 

eMAR in a single ward or unit, provided 

that they are able to meet the 10 percent 

threshold from orders tracked through 

eMAR in that unit. Eligible hospitals 

and CAHs might also elect to implement 

eMAR more widely in order to better 

complement their current workflow. 

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 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. 

Proposed Eligible Hospital/CAH 

Objective: Generate and transmit 

permissible discharge prescriptions 

electronically (eRx) 

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, Certified EHR 

Technology can recognize the 

information and can provide decision 

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3 Ibid. 

support to promote safety and quality in 

the form of adverse interactions and 

other treatment possibilities. The 

Certified EHR Technology 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. 

The HIT Policy Committee 

recommended the inclusion of eRx for 

hospitals for discharge medications. We 

agree that eRx has unique advantages for 

discharge medications versus 

medications dispensed within the 

hospital. Primarily the efficiency of the 

transmission and the information it 

provides to the external pharmacy and/ 

or third party to compare to other 

medication orders received for the 

patient. 

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 

Certified EHR Technology. 

The HIT Policy Committee 

recommended that this measure be 

limited to new or changed prescriptions 

that were ordered during the course of 

treatment of the patient while in the 

hospital. The limitation is necessary 

because prescriptions that originate 

prior to the hospital stay, and that 

remain unchanged, would be within the 

purview of the original prescriber, and 

not hospital staff or attending 

physicians. We propose to include this 

limitation as we agree with the HIT 

Policy Committee that the hospital 

would not issue refills for medications 

they did not authorize or alter during 

their treatment of the patient. We ask 

that commenters consider whether a 

hospital issues refills to patients being 

discharged for medications the patient 

was taking when they arrived at the 

hospital and, if so, whether 

distinguishing those prescriptions from 

new or altered prescriptions is 

unnecessarily burdensome for the 

hospital. 

As this would be a new menu 

objective for hospitals for Stage 2 and 

we continue to have concerns about the 

effect of patient preferences, we are 

proposing a threshold of 10 percent as 

recommended by the HIT Policy 

Committee. We do not believe that an 

exclusion based on the number of 

medications is necessary, as we cannot 

envision a hospital with fewer than 100 

prescriptions, but we do propose an 

exclusion if there are no pharmacies 

that accept electronic prescriptions 

within 25 miles of the hospital. A 

hospital with an internal pharmacy that 

can dispense these electronic 

prescriptions to patients after discharge 

could not qualify for this exclusion. 

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. Not all 

drug formularies are linked to all 

Certified EHR Technologies, so we do 

not require that the formulary be one 

that is relevant for the particular patient. 

Therefore, the comparison could return 

a result of formulary unavailable for that 

patient and medication combination. 

This modification of the measure 

replaces the Stage 1 menu objective of 

‘‘Implement drug-formulary checks’’ 

and is intended to provide better 

integration guidance both for the 

hospital and their supporting vendors. 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

• Denominator: Number of new or 

changed 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, compared to 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 there are no 

pharmacies that accept electronic 

prescriptions within 25 miles 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. 

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, 

this objective aligns with the FIPPs,3 in 

affording baseline privacy protections to 

individuals. We believe that 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 

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. 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 propose this as a core objective for 

hospitals in Stage 2 with the following 

information that must be available as 

part of the objective: 

• Admit and discharge date and 

location. 

• Reason for hospitalization. 

• Providers of care during 

hospitalization. 

• Problem list maintained by the 

hospital on the patient. 

• Relevant past diagnoses known by 

the hospital. 

• Medication list maintained by the 

hospital on the patient (both current 

admission and historical). 

• Medication allergy list maintained 

by the hospital on the patient (both 

current admission and historical). 

• Vital signs at discharge. 

• Laboratory test results (available at 

time of discharge). 

• Care transition summary and plan 

for next provider of care (for transitions 

other than home). 

• Discharge instructions for patient, 

and 

• Demographics maintained by 

hospital (gender, race, ethnicity, date of 

birth, preferred language, smoking 

status). 

This is not intended to limit the 

information made available by the 

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hospital. A hospital can make available 

additional information and still align 

with the objective. 

A hospital has any number of ways to 

make this information available online. 

The hospital can host a patient portal, 

contract with a vendor to host a patient 

portal, connect with an online PHR, or 

other means. As long as the patient can 

view and download the information 

using a standard Web browser and 

internet connection, the means is at the 

discretion of the hospital. 

Proposed 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. 

This objective replaces two Stage 1 

objectives for providing patients 

electronic copies of their health 

information upon request and providing 

electronic copies of discharge 

instructions. In Stage 1 of meaningful 

use, there was a measure of 50 percent 

of patients requesting electronic copies 

(within 3 business days) and discharge 

instructions (at time of discharge) were 

provided to them. The creation of this 

Stage 2 combined objective creates 

different time constraints. The HIT 

Policy Committee recommended 36 

hours from discharge as an appropriate 

time period to meet this measure. We 

see no compelling reason to alter this 

recommendation; however, we 

encourage comment on whether this is 

an appropriate time frame for this new 

measure. 

The second measure represents a new 

concept for meaningful use criteria, 

because it measures the hospital based 

upon the actions of the patient. The HIT 

Policy Committee noted that providers 

would want flexibility with respect to 

the type of guidance provided to 

patients. In turn, the HIT Policy 

Committee recommended best practice 

guidance for providers, vendors, and 

software developments. We believe the 

hospital can sponsor education and 

awareness activities that result in 

patients viewing their information. 

Also, the low threshold of 10 percent 

recognizes that this kind of measure is 

in its earlier stages. A patient who views 

their information online, downloads it 

from the internet or uses the internet to 

transmit it to a third party would count 

for purposes of the numerator. However, 

we recognize, that in areas of the 

country where a significant section of 

the patient population does not have 

access to broadband internet, this 

measure may be significantly harder or 

impossible to achieve. For example, for 

a hospital in an area with 100 percent 

broadband availability, only 10 percent 

of the patient population must view the 

information. However, a hospital in an 

area with 30 percent broadband 

availability must essentially have a third 

of their patient population view the 

information. In addition, areas with 

high broadband penetration tend to 

correlate with more prolific users 

making it more likely that patients will 

view information online. There are 2 

possible solutions to this disparity. The 

first is to exclude hospitals that operate 

in areas with below a certain threshold 

of broadband penetration. The second 

would be to change the measure to 10 

percent of the broadband penetration. 

According to the FCC, 370 counties in 

the United States have broadband 

penetration of less than 50 percent (

www.broadband.gov). Hospitals in areas 

of low broadband availability tend to 

service large areas that may extend 

beyond the county in which the hospital 

is located. Under the first option we 

considered, if the county in which the 

hospital is located has less than 50 

percent 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, the hospital may 

exclude the second measure. Under the 

second option, the hospital would have 

to meet 10 percent of the broadband 

availability according to the FCC in the 

county in which they are located at the 

beginning of the EHR reporting period. 

For example, if the reported availability 

in a county on October 1, 2014, for a 

hospital was 23 percent, the hospital’s 

threshold for the second measure would 

be 2.3 percent. There are counties 

currently with zero percent availability. 

If there is a hospital in a county with 

zero percent availability, those hospitals 

would not have to meet the second 

measure. We propose to adopt the first 

method as we believe the second 

method is too complex to be a practical 

requirement. However, we welcome 

comments on both options as well as the 

correct threshold for the first option. 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

First Measure: 

• 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. 

Second Measure: 

• 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 who view, 

download or transmit to a third party 

the information provided by the eligible 

hospital or CAH online during the EHR 

reporting period. 

• 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 will be excluded from the second 

measure if it is located in a county that 

does not have 50 percent or more of 

their housing units with 4Mbps 

broadband availability according to the 

latest information available from the 

FCC at the start of the EHR reporting 

period is excluded from the second 

measure. 

(e) Objective and Measure Carried Over 

Unmodified From Stage 1 Menu Set to 

Stage 2 Menu Set 

Proposed Eligible Hospital/CAH 

Objective: Record whether a patient 65 

years old or older has an advance 

directive. 

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 Certified EHR Technology or link 

to an electronic copy of the advance 

directive. However, we propose to 

maintain this objective as part of the 

Menu Set and we are not proposing a 

copy or link to the advance directive for 

eligible hospitals and CAHs in Stage 2. 

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 

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workflows may change as EHR 

technology develops and becomes more 

widely adopted. Therefore, we do not 

propose to adopt the HIT Policy 

Committee’s recommendations to 

require this objective as a core measure, 

to store an electronic copy of the 

advance directive in the Certified EHR 

Technology, or to link to an electronic 

copy of the advance directive. 

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 would not 

record this information under current 

standards of practice and would 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 would be excluded 

from the objective would be too 

cumbersome and still might not be 

comprehensive. Therefore, we are not 

proposing the recording of the existence 

of advance directives as an objective for 

EPs in Stage 2. However, we invite 

public comment on this decision and 

encourage 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. 

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 

an indication of an advance directive 

status recorded as structured data. 

We propose that the measure of this 

objective would remain unmodified 

from Stage 1. To calculate the 

percentage, CMS and ONC have worked 

together to define the following for this 

objective: 

• 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. 

Please note 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. 

(f) Other HIT Policy Committee 

Recommended Objectives Not Proposed 

We are not proposing these objectives 

for Stage 2 as explained at each 

objective, but we encourage comments 

on whether these objectives should be 

incorporated into Stage 2. 

Hospital Objective: Provide structured 

electronic lab results to eligible 

professionals. 

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 would need to 

be done so using the capabilities 

Certified EHR Technology. 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 Certified EHR Technology. To 

facilitate the ease with which this 

electronic exchange may take place, 

ONC has proposed that for certification, 

ambulatory EHR technology would need 

to be able to incorporate lab test results 

formatted in the same standard and 

implementation specifications to which 

inpatient EHR technology would need 

to be certified as being able to create. 

However, we are not proposing this 

objective for a variety of reasons. While 

ONC is working to ease the barriers to 

this exchange through certification, this 

assumes that over 40 percent of the 

ordering providers would be utilizing 

Certified EHR Technology. Also, as 

discussed elsewhere, there is more to 

exchange than the established 

standards. Secondly, although hospital 

labs supply nearly half of all lab results 

to EPs, 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 are 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 focuses on the 

inpatient and emergency departments of 

a hospital. This objective is not related 

to these departments, in fact, it 

explicitly excludes services provided in 

these departments. We encourage 

comments on both the pros and cons of 

this objective and whether it should be 

considered for the final rule as 

recommended by the HIT Policy 

Committee. The HIT Policy Committee 

recommended this as a core objective 

for Stage 2 for eligible hospitals. 

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 believe that this requirement is 

better incorporated with other objectives 

that require patient communication and 

is not necessary as a standalone 

objective. 

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 believe that this requirement is 

better incorporated with other objectives 

that require summary of care documents 

and is not necessary as a standalone 

objective. 

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 believe that this requirement is 

better incorporated with other objectives 

that require summary of care documents 

and is not necessary as a standalone 

objective. 

Objective/Measure: Record electronic 

notes in patient records for more than 

30 percent of office visits. 

While we believe that medical 

evaluation entries by providers are an 

important component of patient records 

that can provide information not 

otherwise captured within standardized 

fields, we believe there is evidence to 

suggest that electronic notes are already 

widely used by providers of Certified 

EHR Technology and therefore do not 

need to be included as a meaningful use 

objective. For example, a 2008 survey of 

healthcare professionals indicated that 

75 percent of respondents were already 

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documentation and 74 percent were 

already using the EHR for nursing 

charting/documentation (2008 HIMSS/ 

HIMSS Analytics Ambulatory 

Healthcare IT Survey: http://www.

himss.org/content/files/2008_HA_

HIMSS_ambulatory_Survey.pdf). 

However, we note that ONC has 

included in its Stage 2 proposed rule 

certification capabilities that require 

Certified EHR Technology to allow the 

inclusion of electronic notes that are 

text-searchable. 

Table 4 provides a summary of stage 

2 objectives and measures that we are 

proposing to adopt. 

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B. Reporting on Clinical Quality 

Measures Using Certified EHR 

Technology by Eligible Professionals, 

Eligible Hospitals, and Critical Access 

Hospitals 

1. Time Periods for Reporting Clinical 

Quality Measures 

This section clarifies the time periods 

as they relate to reporting clinical 

quality measures only. We are not 

proposing any changes to the time 

periods for reporting clinical quality 

measures. The EHR reporting period for 

clinical quality measures under the EHR 

Incentive Program is the period during 

which data collection or measurement 

for clinical quality measures occurs. The 

reporting period is consistent with our 

Stage 1 final rule (75 FR 44314) and will 

continue to track with the EHR 

reporting periods for the meaningful use 

criteria: 

• Eligible Professionals (EPs): January 

1 through December 31 (calendar year). 

• Eligible Hospitals and Critical 

Access Hospitals (CAHs): October 1 

through September 30 (Federal fiscal 

year). 

• EPs, eligible hospitals, and CAHs in 

their first year of meaningful use for 

Stage 1, the EHR reporting period would 

be any continuous 90-day period within 

the calendar year (CY) or Federal fiscal 

year (FY), respectively. 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 the 90-day EHR reporting 

period ends at least three months before 

the end of the CY or FY, and that all 

submission is completed by October 1 

or July 1, respectively. For an 

explanation of the applicable EHR 

reporting periods for determining the 

payment adjustments, please see section 

II.D. of this proposed rule. 

TABLE 5—REPORTING ON CLINICAL QUALITY MEASURES USING CERTIFIED EHR TECHNOLOGY BY ELIGIBLE

PROFESSIONALS, ELIGIBLE HOSPITALS AND CRITICAL ACCESS HOSPITALS

Provider type 

Reporting period for first 

year of meaningful use 

(Stage 1) 

Submission period for first 

year of meaningful use 

(Stage 1) 

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 ........................... 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.

1 calendar year (January 1– 

December 31).

2 months following the end 

of the EHR reporting period (January 1–February 

28). 

Eligible Hospital/ 

CAH.

90 consecutive days ............ Anytime immediate following 

the end of the 90-day reporting period, but no later 

than November 30 of the 

following fiscal year.

1 fiscal year (October1–September 30).2 months following the end 

of the EHR reporting period (October 1–November 30). 

For example, for an EP, an EHR 

reporting period would be January 1, 

2014 through December 31, 2014 and is 

the same as CY 2014. If the EP is in his 

or her first year of Stage 1, the EHR 

reporting period could be at the earliest 

from January 1, 2014 through March 31, 

2014 and at the latest from October 3, 

2014 through December 31, 2014. If the 

EP is demonstrating meaningful use for 

the first time in CY 2014, for purposes 

of avoiding the payment adjustment in 

CY 2015, the EHR reporting period must 

end by September 30, 2014. 

For an eligible hospital or CAH, an 

EHR reporting period would be October 

1, 2013 through September 30, 2014 and 

is the same as FY 2014. If the eligible 

hospital or CAH is in its first year of 

meaningful use for Stage 1, the EHR 

reporting period could be at the earliest 

from October 1, 2013 through December 

29, 2013 and at the latest from July 3, 

2014 through September 30, 2014. If an 

eligible hospital is demonstrating 

meaningful use for the first time in FY 

2014, for purposes of avoiding the 

payment adjustment in FY 2015, the 

EHR reporting period must end by June 

30, 2014. 

For EPs, eligible hospitals, and CAHs, 

the submission period for clinical 

quality measure data to us generally 

would be 2 months immediately 

following the end of the EHR reporting 

period: 

• Eligible Professionals: 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 could submit 

clinical quality measure data anytime 

after their respective 90-day EHR 

reporting period up to 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 

clinical quality measure data no later 

than October 1 (for EPs) or July 1 (for 

eligible hospitals) of such preceding 

year. 

Using the same examples for the EHR 

reporting periods previously for an EP, 

the submission period for CY 2014 

would be January 1, 2015 through 

February 28, 2015. If the EP is in his or 

her first year of Stage 1, the submission 

period could begin at the earliest April 

1, 2014 and would end February 28, 

2015. However, if the EP is 

demonstrating meaningful use for the 

first time in CY 2014, for purposes of 

avoiding the payment adjustment in CY 

2015, the clinical quality measure data 

must be submitted by October 1, 2014. 

Using the same examples for the EHR 

reporting periods previously for an 

eligible hospital and CAH, the 

submission period for FY 2014 would 

be October 1, 2014 through November 

30, 2014. If the eligible hospital and 

CAH is in its first year of Stage 1, the 

submission period could begin at the 

earliest December 30, 2013 and would 

end November 30, 2014. However, if an 

eligible hospital is demonstrating 

meaningful use for the first time in FY 

2014, for purposes of avoiding the 

payment adjustment in FY 2015, the 

clinical quality measure data must be 

submitted by July 1, 2014. 

2. Certification Requirements for 

Clinical Quality Measures 

The Office of the National 

Coordinator (ONC) sets the certification 

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criteria for EHR technology, which for 

clinical quality measures are described 

in 45 CFR 170.314(c) in ONC’s proposed 

rule published elsewhere in this issue of 

the Federal Register. Certified EHR 

Technology will be required for the 

reporting methods finalized from this 

proposed rule. This may include 

attestation, reporting under the PQRS 

EHR reporting option, the group 

reporting options for EPs, the aggregate 

portal-based reporting methods, and the 

finalized reporting method for eligible 

hospitals and CAHs. Readers should 

refer to ONC’s proposed rule for an 

explanation of the definition of Certified 

EHR Technology that would apply 

beginning with 2014. 

In addition, for attestation and the 

aggregate portal-based reporting 

methods for EPs, eligible hospitals and 

CAHs, Certified EHR Technology must 

be certified to ‘‘incorporate and 

calculate’’ in accordance with 45 CFR 

170.314(c)(2) for each individual 

clinical quality measure that an EP, 

eligible hospital or CAH submits. EPs, 

eligible hospitals and CAHs must only 

submit clinical quality measures that 

their Certified EHR Technology is 

explicitly certified to calculate 

according to 45 CFR 170.314(c)(2) in 

ONC’s proposed rule in order to meet 

the meaningful use requirement for 

reporting clinical quality measures. For 

example, if an EP’s Certified EHR 

Technology is only certified to calculate 

clinical quality measures #1 through 

#12, and the EP submits clinical quality 

measures #1 through #11 and #37, the 

EP would not have met the meaningful 

use requirement for reporting clinical 

quality measures because his/her 

Certified EHR Technology was not 

certified to calculate clinical quality 

measure #37. 

Likewise, for attestation and the 

aggregate portal-based reporting 

methods, Certified EHR Technology 

must be certified for ‘‘reporting’’ (please 

refer to the discussion of 45 CFR 

170.314(c)(3) in ONC’s proposed rule), 

which certifies the capability to create 

and transmit a standard aggregate XMLbased file that can be electronically 

accepted by CMS. 

3. Criteria for Selecting Clinical Quality 

Measures 

We are soliciting comment on a wide 

ranging list of 125 potential measures 

for EPs and 49 potential measures for 

eligible hospitals and CAHs. We expect 

to finalize only a subset of these 

proposed measures. 

We are committed to aligning quality 

measurement and reporting among our 

programs (for example, IQR, PQRS, 

CHIPRA, ACO programs). Our 

alignment efforts focus on several fronts 

including choosing the same measures 

for different program measure sets, 

standardizing measure development and 

specification processes across CMS 

programs, coordinating quality 

measurement stakeholder involvement 

efforts and opportunities for public 

input, and identifying ways to minimize 

multiple submission requirements and 

mechanisms. For example, we are 

working towards allowing CQM data 

submitted via certified EHRs by EPs and 

EHs/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 believe the alignment 

options for PQRS/EHR Incentive 

Program proposed in this rule are the 

first step towards such a vision. We are 

exploring how 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 

ACA measure sets, etc). This would 

lessen provider burden and harmonize 

with our data exchange priorities, while 

also supporting our goal of the programs 

transforming our system to provide 

higher quality care, better health 

outcomes, and lower cost through 

improvement. 

In addition to statutory requirements 

for EPs (section II.B.4.(a) of this 

proposed rule), eligible hospitals 

(section II.B.6.(a) of this proposed rule), 

and CAHs (section II.B.6.(a) of this 

proposed rule), we relied on the 

following criteria to select this initial 

list of proposed clinical quality 

measures for EPs, eligible hospitals, and 

CAHs: 

• 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. 

• Measures 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 Congress, ‘‘National Strategy 

for Quality Improvement in Health 

Care’’ (National Quality Strategy) 

(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). 

These include the following 6 priorities: 

++ Making care safer by reducing 

harm caused in the delivery of care. 

++ Ensuring that each person and 

family are engaged as partners in their 

care. 

++ Promoting effective 

communication and coordination of 

care. 

++ Promoting the most effective 

prevention and treatment practices for 

the leading causes of mortality, starting 

with cardiovascular disease. 

++ Working with communities to 

promote wide use of best practices to 

enable healthy living. 

++ Making quality care more 

affordable for individuals, families, 

employers, and governments by 

developing and spreading new health 

care delivery models. 

• Measures 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. 

• Measures that address areas of care 

for different types of eligible 

professionals (for example, Medicareand Medicaid-eligible physicians, and 

Medicaid-eligible nurse-practitioners, 

certified nurse-midwives, dentists, 

physician assistants). 

In an effort to align the clinical 

quality measures used within the EHR 

Incentive Program with the goals of 

CMS and HHS, the National Quality 

Strategy, and the HITPC’s 

recommendations, we have assessed all 

proposed measures against six domains 

based on the National Quality Strategy’s 

six priorities, which were developed by 

the HITPC Workgroups, as follows: 

• Patient and Family Engagement. 

These are measures 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 

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families in decision making, self care, 

activation, and understanding of their 

health condition and its effective 

management. 

• Patient Safety. These are measures 

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 

measures 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 measures 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 measures that 

reflect efforts to significantly improve 

outcomes and reduce errors. These 

measures 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 measures that reflect clinical 

care processes closely linked to 

outcomes based on evidence and 

practice guidelines. 

We welcome comments on these 

domains, and whether they will 

adequately align with and support the 

breadth of CMS and HHS activities to 

improve quality of care and health 

outcomes. 

We also considered the 

recommendations of the Measure 

Applications Partnership (MAP) for 

inclusion of clinical quality measures. 

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 PreRulemaking Report on January 11, 2012 

(http://www.qualityforum.org/map/), 

which includes a list of, and rationales 

for, all the clinical quality measures that 

the MAP did not support. The MAP did 

not review the clinical quality measures 

for 2011 and 2012 that were previously 

adopted for the EHR Incentive Program 

in the Stage 1 final rule. We have 

included some of the clinical quality 

measures not supported by the MAP in 

Tables 8 (EPs) and 9 (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 included some measures to 

address specialty areas that may not 

have had applicable measures in the 

Stage 1 final rule. 

We anticipate that only a subset of 

these measures will be finalized. When 

considering which measures to finalize, 

we will take into account public 

comment on the measures themselves 

and the priorities listed previously. We 

intend to prioritize measures that align 

with and support the measurement 

needs of CMS program activities related 

to quality of care, delivery system 

reform, and payment reform, especially: 

• 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. 

4. Measure Specification 

We do not intend to use notice and 

comment rulemaking as a means to 

update or modify clinical quality 

measure specifications. A clinical 

quality measure that has completed the 

consensus process has a measure 

steward who has accepted responsibility 

for maintaining and updating the 

measure. In general, it is the role of the 

measure steward to make changes to a 

measure in terms of the initial patient 

population, numerator, denominator, 

and potential exclusions. We recognize 

that it may be necessary to update 

measure 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 measure, correcting faulty 

logic, adding or deleting codes as well 

as providing additional implementation 

guidance for a measure. These changes 

would be described in full through 

supplemental updates to the electronic 

specifications for EHR submission 

provided by CMS. 

The complete measure 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 when 

considering the proposed clinical 

quality measures in this proposed rule, 

we would publish tables titled 

‘‘Proposed Clinical Quality Measures for 

2014 CMS EHR Incentive Programs for 

Eligible Professionals’’ and ‘‘Proposed 

Clinical Quality Measures for 2014 CMS 

EHR Incentive Programs for Eligible 

Hospitals and CAHs’’ on this Web site 

at or around the time of the publication 

of this proposed rule. These tables 

contain additional information for the 

EP, eligible hospital and CAH clinical 

quality measures, respectively, which 

may not be found on the NQF Web site. 

Some of these measures are still being 

developed, therefore the additional 

descriptions provided in these tables 

may still change before the final rule is 

published. Public comments regarding 

these measures should be submitted 

using the same method required for all 

other comments related to this proposed 

rule. Please note that the titles and 

descriptions for the clinical quality 

measures included in these tables were 

updated by the measure stewards and 

therefore may not match the information 

provided on the NQF Web site. 

Measures that do not have an NQF 

number are not currently endorsed. 

Measures would be tracked on a 

version basis as updates to those 

measures are made. We would require 

all EPs, eligible hospitals, and CAHs to 

submit the versions of the clinical 

quality measure as identified on our 

Web site, and they would need to 

include the version numbers when they 

report the measure. It is our intent to 

include the version numbers with our 

updates to the measure specifications. 

Under certain circumstances, we 

believe it may be necessary to remove a 

clinical quality measure from the EHR 

Incentive Program between rulemaking 

cycles. When there is reason to believe 

that the continued collection of a 

measure as it is currently specified 

raises potential patient safety concerns 

and/or is no longer scientifically valid, 

it would be appropriate for us to take 

immediate action to remove the measure 

from the EHR Incentive Program and not 

wait for the rulemaking cycle. Likewise, 

if a clinical quality measure undergoes 

a substantive change by the measure 

steward between rulemaking cycles 

such that the measure’s intent has 

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changed, we would expect to remove 

the measure immediately from the EHR 

Incentive Program until the next 

rulemaking cycle when we could 

propose the revised measure for public 

comment. Under this policy, we would 

promptly remove such clinical quality 

measures from the set of measures 

available for providers to report under 

the EHR Incentive Program, confirm the 

removal (or propose the revised 

measure) in the next EHR Incentive 

Program rulemaking cycle, and notify 

providers (EPs, eligible hospitals, and 

CAHs) and the public of our decision to 

remove the measure(s) through the 

usual communication channels (memos, 

email notification, Web site postings). 

5. Proposed Clinical Quality Measures 

for Eligible Professionals 

(a) Statutory and Other Considerations 

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

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

reporting of clinical quality measures by 

EPs as part of demonstrating meaningful 

use of Certified EHR Technology. 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 Certified EHR 

Technology under Medicare and 

Medicaid. Therefore, to meet this 

requirement, we continue our practice 

from Stage 1 of proposing clinical 

quality measures that would apply for 

both the Medicare and Medicaid EHR 

Incentive Programs, as listed in sections 

II.B.4.(b). and II.B.4.(c). of this proposed 

rule. 

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

requires that in selecting measures 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 Physician 

Quality Reporting System). Consistent 

with that requirement, we are proposing 

to select clinical quality measures for 

EPs for the EHR Incentive Programs that 

align with other existing quality 

programs such as the Physician Quality 

Reporting System (PQRS) (76 FR 73026), 

the Medicare Shared Savings Program 

(76 FR 67802), measures used by the 

National Committee for Quality 

Assurance (NCQA) for medical home 

accreditation (http://ncqa.org), the 

Health Resources and Services 

Administration’s (HRSA) Uniform Data 

System (UDS) (75 FR 73170), Children’s 

Health Insurance Program 

Reauthorization Act (CHIPRA) (75 FR 

44314), and the final Section 2701 adult 

measures under the Affordable Care Act 

(ACA) published in the Federal Register 

on January 4, 2012 (77 FR 286). When 

a measure is included in more than one 

CMS quality reporting program and is 

reported using Certified EHR 

Technology, we would seek to avoid 

requiring EPs to report the same clinical 

quality measure 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 clinical quality measures endorsed by 

the entity with a contract with the 

Secretary under section 1890(a) 

(namely, the National Quality Forum 

(NQF)). We are proposing clinical 

quality measures for EPs 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 NQF endorsed 

measures for the EHR Incentive 

Programs. Measures listed in this 

proposed rule that do not have an NQF 

identifying number are not NQF 

endorsed, but are included in this 

proposed rule with the intent of 

eventually obtaining NQF endorsement 

of those measures determined to be 

critical to our program. 

Per the preamble discussion in the 

Stage 1 final rule regarding measures 

gaps and Medicaid providers (75 FR 

44506), we are proposing to increase the 

total number of clinical quality 

measures for EPs in order to cover areas 

noted by commenters such as behavioral 

health, dental care, long-term care, 

special needs populations, and care 

coordination. The new measures we are 

proposing beginning with CY 2014 

include new pediatric measures, an 

obstetric measure, behavioral/mental 

health measures, and measures related 

to HIV medical visits and antiretroviral 

therapy, as well as other measures that 

address National Quality Strategy goals. 

We recognize that we do not have 

additional measures to propose 

beginning with CY 2014 in the areas of 

long-term and post-acute care. Since the 

publication of the Stage 1 final rule, we 

have partnered with the National 

Governor’s Association to participate in 

a panel with long-term care and health 

information exchange experts to gain 

insight and consensus on possible 

clinical quality measures. At this time, 

however, no clinical quality measures 

for long-term and post-acute care have 

been identified as being ready 

(electronically specified) beginning with 

CY 2014. We expect to continue to 

develop or identify clinical quality 

measures for these areas with our 

partners and stakeholders for future 

years. 

We are pleased to propose two oral 

health measures beginning with CY 

2014. In the past year, we partnered 

with Agency for Healthcare Research 

and Quality (AHRQ) to solicit input 

from a technical expert panel to identify 

barriers to the adoption and use of 

health IT for oral health care providers. 

A final report titled ‘‘Quality Oral 

Health Care in Medicaid Through 

Health IT’’ is available at http:// 

healthit.ahrq.gov/portal/server.pt/ 

community/ahrq-fundedprojects/654/ 

medicaid-schip/14760. CMS, the 

American Dental Association, and the 

Dental Quality Alliance have all 

strategized ways to encourage and 

support the use of EHRs for oral health 

providers. We expect to continue to 

develop or identify clinical quality 

measures for dental/oral health care 

with our partners and stakeholders that 

could be ready for future years. 

(b) Proposed Clinical Quality Measures 

for Eligible Professionals for CY 2013 

We propose that for the EHR reporting 

periods in CY 2013, EPs must submit 

data for the clinical quality measures 

that were finalized in the Stage 1 final 

rule for CYs 2011 and 2012 (75 FR 

44398 through 44411, Tables 6 and 7). 

Updates to these clinical quality 

measures’ electronic specifications are 

expected to be posted on the EHR 

Incentive Program Web site at least 6 

months prior to the start of CY 2013 

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

03_ElectronicSpecifications.asp). As 

required by the Stage 1 final rule, EPs 

must report on three core or alternate 

core measures, plus three additional 

measures. We refer readers to the 

discussion in the Stage 1 final rule for 

further explanation of the requirements 

for reporting those clinical quality 

measures (75 FR 44398 through 44411). 

The proposed reporting methods for EPs 

for CY 2013 are discussed in sections 

II.B.5.(a). and II.B.5.(b). of this proposed 

rule. 

(c) Proposed Clinical Quality Measures 

for Eligible Professionals Beginning 

With CY 2014 

We are proposing two reporting 

options that would begin in CY 2014 for 

Medicare and Medicaid EPs, as 

described below: Options 1 and 2. For 

Options 1, we are proposing the 

following two alternatives, but intend to 

finalize only a single method: 

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13746 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 

• Option 1a: EPs would report 12 

clinical quality measures from those 

listed in Table 8, including at least 1 

measure from each of the 6 domains. 

• Option 1b: EPs would report 11 

‘‘core’’ clinical quality measures listed 

in Table 6 plus 1 ‘‘menu’’ clinical 

quality measure from Table 8. 

We welcome comment regarding the 

advantages and disadvantages of 

Options 1a and 1b, including EP 

preference, the appropriateness of the 

domains, the number of clinical quality 

measures required, and the appropriate 

split between ‘‘core’’ and ‘‘menu’’ 

clinical quality measures. It is our intent 

to finalize the most operationally viable 

and appropriate option or combination 

of options in our final rule. As an 

alternative to Options 1a or 1b, 

Medicare EPs who participate in both 

the Physician Quality Reporting System 

and the EHR Incentive Program may 

choose Option 2, as described below 

(the Physician Quality Reporting System 

EHR Reporting Option). 

We are proposing clinical quality 

measures in Table 8 that would apply to 

all EPs for the EHR reporting periods in 

CYs 2014 and 2015 (and potentially 

subsequent years), regardless of whether 

an EP is in Stage 1 or Stage 2 of 

meaningful use. For Medicaid EPs, the 

reporting method for clinical quality 

measures may vary by State. However, 

the set of clinical quality measures from 

which to select (Table 8) would be the 

same for both Medicaid EPs and 

Medicare EPs. Medicare EPs who are in 

their first year of Stage 1 of meaningful 

use may report clinical quality measures 

through attestation during the 2 months 

immediately following the end of the 

90-day EHR reporting period as 

described in section II.B.1. of this 

proposed rule. Readers should refer to 

the discussion in the Stage 1 final rule 

for more information about reporting 

clinical quality measures through 

attestation (75 FR 44430 through 44431). 

We expect that by CY 2016, we will 

have engaged in another round of 

rulemaking for the EHR Incentive 

Programs. However, in the unlikely 

event such rulemaking does not occur, 

the clinical quality measures proposed 

for CYs 2014 and 2015 would continue 

to apply for the EHR reporting periods 

in CY 2016 and subsequent years. 

Therefore, we refer to clinical quality 

measures that apply ‘‘beginning with’’ 

or ‘‘beginning in’’ CY 2014. 

• Option 1a: Select and submit 12 

clinical quality measures from Table 8, 

including at least 1 measure from each 

of the 6 domains. 

We are proposing that EPs must report 

12 clinical quality measures from those 

listed in Table 8, which must include at 

least one measure from each of the 

following 6 domains, which are 

described in section II.B.3. of this 

proposed rule: 

• Patient and Family Engagement. 

• Patient Safety. 

• Care Coordination. 

• Population and Public Health. 

• Efficient Use of Healthcare 

Resources. 

• Clinical Process/Effectiveness. 

EPs would select the clinical quality 

measures that best apply to their scope 

of practice and/or unique patient 

population. If an EP’s Certified EHR 

Technology does not contain patient 

data for at least 12 clinical quality 

measures, then the EP must report the 

clinical quality measures for which 

there is patient data and report the 

remaining required clinical quality 

measures as ‘‘zero denominators’’ as 

displayed by the EPs Certified EHR 

Technology. If there are no clinical 

quality measures applicable to the EP’s 

scope of practice or unique patient 

populations, EPs must still report 12 

clinical quality measures even if zero is 

the result in either the numerator and/ 

or the denominator of the measure. If all 

applicable clinical quality measures 

have a value of zero from their Certified 

EHR Technology, then EPs must report 

any 12 of the clinical quality measures. 

For this option, the clinical quality 

measures data would be submitted in an 

XML-based format on an aggregate basis 

reflective of all patients without regard 

to payer. One advantage of this 

approach is that EPs can choose 

measures that best fit their practice and 

patient populations. However, because 

of the large number of measures to 

choose from, this approach would result 

in fewer EPs reporting on any given 

measure, and likely only a small sample 

of patient data represented in each 

measure. 

• Option 1b: Submit 12 clinical 

quality measures composed of all 11 of 

the core clinical quality measures in 

Table 6 plus 1 menu clinical quality 

measure from Table 8. 

We are considering a ‘‘core’’ clinical 

quality measure set that all EPs must 

report, which will reflect the national 

priorities outlined in section II.B.3. of 

this proposed rule. In addition to the 

core clinical quality measure set, we are 

considering a ‘‘menu’’ set from which 

EPs would select 1 clinical quality 

measure to report based on their 

respective scope of practice and/or 

unique patient population. One 

advantage of this approach is that 

quality data would be collected on a 

smaller set of measures, so the resulting 

data for each measure would represent 

a larger number of patients and 

therefore could be more accurate. 

However, this approach could mean that 

more measures are reported with zero 

denominators (if they are not applicable 

to certain practices or populations), 

making the data less comprehensive. 

The menu set would consist of the 

measures in Table 8 that are not part of 

the core clinical quality measure set. 

The core clinical quality measure set for 

EPs consists of the following measures 

in Table 6 (these clinical quality 

measures are also in Table 8): 

TABLE 6—POTENTIAL CORE CLINICAL QUALITY MEASURE SET TO BE REPORTED BY ELIGIBLE PROFESSIONALS BEGINNING

IN CY 2014 

Measure 

Number Clinical quality measure title & description Clinical quality measure steward & contact information Domain 

TBD .................... Title: Closing the referral loop: receipt of specialist report Description: Percentage of patients regardless of age with a referral from 

a primary care provider for whom a report from the provider to 

whom the patient was referred was received by the referring provider.

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.usqualitymeasures.org.

Care Coordination. 

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Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 13747 

TABLE 6—POTENTIAL CORE CLINICAL QUALITY MEASURE SET TO BE REPORTED BY ELIGIBLE PROFESSIONALS BEGINNING

IN CY 2014—Continued 

Measure 

Number Clinical quality measure title & description Clinical quality measure steward & contact information Domain 

TBD .................... Title: Functional status assessment for complex chronic conditions; 

Description: Percentage of patients aged 65 years and older with 

heart failure and two or more high impact conditions 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.

Patient and 

Family Engagement. 

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 during the 

measurement year.

NCQA Contact Information: 

www.ncqa.org.

Clinical Process/ 

Effectiveness. 

NQF 0097 ........... Title: Medication Reconciliation; Description: Percentage of patients 

aged 65 years and older discharged from any inpatient facility 

(e.g. hospital, skilled nursing facility, or rehabilitation facility) and 

seen within 60 days following discharge in the office by the physician providing on-going care who had a reconciliation of the discharge medications with the current medication list in the medical 

record documented.

AMA–PCPI Contact Information: 

cpe@ama-assn.org; National 

Committee for Quality Assurance (NCQA) Contact information: www.ncqa.org.

Patient Safety. 

NQF 0418 ........... Title: Screening for Clinical Depression; Description: Percentage of 

patients aged 12 years and older screened for clinical depression 

using an age appropriate standardized tool and follow up plan 

documented.

CMS 1–888–734–6433 or http://

questions.cms.hhs.gov/app/ask/

p/21,26,1139.

Population/Public 

Health. 

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@ama-assn.org.

Population/Public 

Health. 

TBD .................... Title: Preventive Care and Screening: Cholesterol—Fasting Low 

Density Lipoprotein (LDL) Test Performed AND Risk-Stratified 

Fasting LDL; Description: Percentage of patients aged 20 through 

79 years whose risk factors * have been assessed and a fasting 

LDL test has been performed. Percentage of patients aged 20 

through 79 years who had a fasting LDL test performed and 

whose risk-stratified* fasting LDL is at or below the recommended 

LDL goal.

CMS 1–888–734–6433 or http://

questions.cms.hhs.gov/app/ask/

p/21,26,1139; QIP Contact Information: www.usqualitymeasures.org.

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 transluminal coronary angioplasty (PTCA) from January 1–November 1 of the year prior to the measurement year, or 

who had a diagnosis of ischemic vascular disease (IVD) during 

the measurement year and the year prior to the measurement 

year and who had documentation of use of aspirin or another 

antithrombotic during the measurement year.

NCQA Contact Information: 

www.ncqa.org.

Clinical Process/ 

Effectiveness. 

NQF 0024 ........... Title: Weight Assessment and Counseling for Nutrition and Physical 

Activity for Children and Adolescents; Description: Percentage of 

patients 3–17 years of age who had an outpatient visit with a Primary Care Physician (PCP) or OB/GYN and who had evidence of 

body mass index (BMI) percentile documentation, counseling for 

nutrition and counseling for physical activity during the measurement year.

NCQA Contact information: 

www.ncqa.org.

Population/Public 

Health. 

NQF 0022 ........... Title: Use of High-Risk Medications in the Elderly; Description: Percentage of patients ages 65 years and older who received at least 

one high-risk medication. Percentage of patients 65 years of age 

and older who received at least two different high-risk medications.

NCQA Contact Information: 

www.ncqa.org.

Patient Safety. 

TBD .................... Title: Adverse Drug Event (ADE) Prevention: Outpatient therapeutic 

drug monitoring; Description: Percentage of patients 18 years of 

age and older receiving outpatient chronic medication therapy 

who had the appropriate therapeutic drug monitoring during the 

measurement year.

CMS 1–888–734–6433 or http://

questions.cms.hhs.gov/app/ask/

p/21,26,1139.

Patient Safety. 

We selected these measures for the 

proposed core set based upon analysis 

of several factors that include: 

conditions that contribute the most to 

Medicare and Medicaid beneficiaries’ 

morbidity and mortality; conditions that 

represent national public/population 

health priorities; conditions that are 

common to health disparities; those 

conditions that disproportionately drive 

healthcare costs that could improve 

with better quality measurement; 

measures that would enable CMS, 

States, and the provider community to 

measure quality of care in new 

dimensions with a stronger focus on 

parsimonious measurement; and those 

measures that include patient and/or 

caregiver engagement. 

We request public comment on the 

core and menu set reporting schema 

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13748 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 

described as well as the number and 

appropriateness of the core set listed in 

Table 6. We are considering that all 

identified core clinical quality measures 

must be reported by all EPs in addition 

to a menu set clinical quality measure. 

The policy on reporting ‘‘zeros’’ 

discussed previously under Option 1a 

would also apply for this core and menu 

option. In this option, an EP who does 

not report all of the identified core 

clinical quality measures, plus a menu 

set clinical quality measure, would have 

not met the requirements for submitting 

the clinical quality measures. 

• Option 2: Submit and satisfactorily 

report clinical quality measures under 

the Physician Quality Reporting 

System’s EHR Reporting Option. 

We propose an alternative option for 

Medicare EPs who participate in both 

the Physician Quality Reporting System 

and the EHR Incentive Program. As an 

alternative to reporting the 12 clinical 

quality measures as described under 

Options 1a and 1b, and in order to 

streamline quality reporting options for 

participating providers, Medicare EPs 

who submit and satisfactorily report 

Physician Quality Reporting System 

clinical quality measures under the 

Physician Quality Reporting System’s 

EHR reporting option using Certified 

EHR Technology would satisfy their 

clinical quality measures reporting 

requirement under the Medicare EHR 

Incentive Program. For more 

information about the requirements of 

the Physician Quality Reporting System, 

we refer readers to 42 CFR 414.90 and 

the CY 2012 Medicare Physician Fee 

Schedule final rule with comment 

period (76 FR 73314). EPs who choose 

this option to satisfy their clinical 

quality measures reporting obligation 

under the Medicare EHR Incentive 

Program would be required to comply 

with any changes to the requirements of 

the Physician Quality Reporting System 

that may apply in future years. 

Table 7 lists the clinical quality 

measures that were finalized in the 

Stage 1 final rule (75 FR 44398 through 

44408) that we are proposing to 

eliminate beginning with CY 2014. 

TABLE 7—CLINICAL QUALITY MEASURES INCLUDED IN THE STAGE 1 FINAL RULE THAT ARE PROPOSED TO BE ELIMINATED

BEGINNING IN CY 2014 

Measure No. Clinical quality measure title & description Clinical quality measure developer * & 

contact information 

NQF# 0013 ............. Title: Hypertension: Blood Pressure Management; Description: Percentage of 

patient visits aged 18 years and older with a diagnosis of hypertension who 

have been seen for at least 2 office visits, with blood pressure (BP) recorded.

AMA–PCPI Contact Information: 

cpe@ama-assn.org. 

NQF# 0027 ............. Title: Smoking and Tobacco Use Cessation, Medical Assistance: a. Advising 

Smokers and Tobacco Users to Quit, b. Discussing Smoking and Tobacco 

Use Cessation Strategies.

NCQA Contact Information: 

www.ncqa.org. 

NQF# 0084 ............. Title: Heart Failure (HF): Warfarin Therapy Patients with Atrial Fibrillation; Description: Percentage of all patients aged 18 years and older with a diagnosis 

of heart failure and paroxysmal or chronic atrial fibrillation who were prescribed warfarin therapy.

AMA–PCPI Contact Information: 

cpe@ama-assn.org. 

*AMA–PCPI = American Medical Association-Physician Consortium for Performance Improvement. 

NCQA = National Committee for Quality Assurance. 

Based in part on the feedback 

received throughout Stage 1, we propose 

to eliminate these three clinical quality 

measures beginning with CY 2014 for 

EPs at all Stages for the following 

reasons: 

• NQF # 0013—The measure steward 

did not submit this measure to the 

National Quality Forum for continued 

endorsement. We have included other 

measures that address high blood 

pressure and hypertension in Table 8. 

• NQF #0027—We determined this 

measure is very similar to NQF #0028 a 

and b; therefore, to avoid duplication of 

measures, we propose to only retain 

NQF # 0028 a and b. 

• NQF #0084—The measure steward 

did not submit this measure to the 

National Quality Forum for continued 

endorsement. Additionally, CMS has 

decided to remove this measure because 

there are other FDA-approved 

anticoagulant therapies available in 

addition to Warfarin. We are proposing 

to replace this measure, pending 

availability of electronic specifications, 

with NQF #1525—Atrial Fibrillation 

and Atrial Flutter: Chronic 

Anticoagulation Therapy. 

Table 8 lists all of the clinical quality 

measures that we are considering for 

EPs to report for the EHR Incentive 

Programs beginning with CY 2014. 

However, we expect to finalize only a 

subset of these proposed measures 

based on public comment and the 

priorities listed in section II.B.3. of this 

proposed rule. The measures 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. Measures which are 

designated as ‘‘New’’ in the ‘‘New 

Measures’’ column were not finalized in 

the Stage 1 final rule. Please note that 

measures which are listed as also being 

part of the ‘‘ACO’’ program in the 

‘‘Other Quality Programs that Use the 

Same Measure’’ column of Table 8 are 

Medicare Shared Savings Program 

measures. Some of the clinical quality 

measures in Table 8 will require the 

development of electronic 

specifications. Therefore, we propose to 

consider these measures for inclusion 

beginning with CY 2014 based on our 

expectation that their electronic 

specifications will be available at the 

time of or within a reasonable period 

after the publication of the final rule. 

Additionally, some of these measures 

have not yet been submitted for 

consensus endorsement consideration 

or are currently under review for 

endorsement consideration by the 

National Quality Forum. We expect that 

any measure proposed in Table 8 for 

inclusion beginning with CY 2014 will 

be submitted for endorsement 

consideration by the measure steward. 

The finalized list of measures that 

would apply for EPs beginning with CY 

2014 will be published in the final rule. 

Because measure specifications may 

need to be updated more frequently 

than our expected rulemaking cycle 

would allow for, 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 expect to 

update specifications annually. All 

clinical quality measure specification 

updates, including a schedule for 

updates to electronic specifications, 

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would be posted on the EHR Incentive 

Program Web site (https://www.cms.gov/ 

QualityMeasures/ 

03_ElectronicSpecifications.asp), and 

we would notify the public of the 

posting. 

TABLE 8—CLINICAL QUALITY MEASURES PROPOSED FOR MEDICARE AND MEDICAID ELIGIBLE PROFESSIONALS BEGINNING

WITH CY 2014 

Measure No. Clinical quality measure title & description Clinical quality measure steward & contact information 

Other quality measure 

programs that use the same measure** 

New 

measure Domain 

NQF 0001 ........... Title: Asthma: Assessment of Asthma Control ....................................

Description: Percentage of patients aged 5 through 50 years with a 

diagnosis of asthma who were evaluated at least once for asthma 

control (comprising asthma impairment and asthma risk).

American Medical Association-Physician Consortium for Performance 

Improvement (AMA–PCPI).

Contact Information: cpe@amaassn.org.

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

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

Description: Percentage of children 2–18 years of age who were diagnosed with pharyngitis, dispensed 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: (a) Initiation, (b) Engagement.

Description: The percentage of adolescent and adult patients with a 

new episode of alcohol and other drug (AOD) dependence who 

initiate treatment through an inpatient AOD admission, outpatient 

visit, intensive outpatient encounter or partial hospitalization within 

14 days of the diagnosis and who initiated treatment and who had 

two or more additional services with an AOD diagnosis within 30 

days of the initiation visit.

NCQA .................................................

Contact Information: www.ncqa.org. 

EHR PQRS, HEDIS, 

State use, ACA 2701, 

NCQA–PCMH Accreditation.

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

NQF 0012 ........... Title: Prenatal Care: Screening for Human Immunodeficiency Virus 

(HIV).

Description: Percentage of patients, regardless of age, who gave 

birth during a 12-month period who were screened for HIV infection during the first or second prenatal care visit.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

EHR PQRS .................. ............... Population/Public 

Health. 

NQF 0014 ........... Title: Prenatal Care: Anti-D Immune Globulin .....................................

Description: Percentage of D (Rh) negative, unsensitized patients, 

regardless of age, who gave birth during a 12-month period who 

received anti-D immune globulin at 26–30 weeks gestation.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

EHR PQRS, NCQA– 

PCMH Accreditation.

............... Patient Safety. 

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 during the measurement year.

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 ages 65 years and older who received at least one high-risk medication. Percentage of patients 

65 years of age and older who received at least two different 

high-risk medications.

NCQA .................................................

Contact Information: www.ncqa.org. 

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

NQF 0024 ........... Title: Weight Assessment and Counseling for Nutrition and Physical 

Activity for Children and Adolescents.

Description: Percentage of patients 3–17 years of age who had an 

outpatient visit with a Primary Care Physician (PCP) or OB/GYN 

and who had evidence of body mass index (BMI) percentile documentation, counseling for nutrition and counseling for physical activity during the measurement year.

NCQA .................................................

Contact Information: www.ncqa.org. 

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

Health. 

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 Accreditation.

............... 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 Accreditation, UDS.

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

NQF 0033 ........... Title: Chlamydia Screening in 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 year.

NCQA .................................................

Contact Information: www.ncqa.org. 

EHR PQRS, CHIPRA, 

ACA 2701, HEDIS, 

State use, NCQA– 

PCMH Accreditation.

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

Health. 

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 Accreditation.

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

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

Description: Percentage of patients 5–50 years of age who were 

identified as having persistent asthma and were appropriately prescribed medication during the measurement year. Report three 

age stratifications (5–11 years, 12–50 years, and total).

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); two H influenza 

type B (HiB); three hepatitis B (Hep B); one chicken pox (VZV); 

four pneumococcal conjugate (PCV); two hepatitis A (Hep A); two 

or three rotavirus (RV); and two influenza (flu) vaccines by their 

second birthday. The measure calculates a rate for each vaccine 

and nine separate combination rates.

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. 

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TABLE 8—CLINICAL QUALITY MEASURES PROPOSED FOR MEDICARE AND MEDICAID ELIGIBLE PROFESSIONALS BEGINNING

WITH CY 2014—Continued 

Measure No. Clinical quality measure title & description Clinical quality measure steward & 

contact information 

Other quality measure 

programs that use the 

same measure** 

New 

measure Domain 

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 Accreditation.

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

NQF 0045 ........... Title: Osteoporosis: Communication with the Physician Managing 

Ongoing Care Post-Fracture.

Description: Percentage of patients aged 50 years and older treated 

for a hip, spine, or distal radial fracture with documentation of 

communication with the physician managing the patient’s ongoing care that a fracture occurred and that the patient was or 

should be tested or treated for osteoporosis.

NCQA .................................................

Contact Information: www.ncqa.org. 

PQRS, NCQA–PCMH 

Accreditation.

New ...... Care Coordination. 

NQF 0046 ........... Title: Osteoporosis: Screening or Therapy for Osteoporosis for 

Women Aged 65 Years and Older.

Description: Percentage of female patients aged 65 years and older 

who have a central dual-energy X-ray absorptiometry measurement ordered or performed at least once since age 60 or pharmacologic therapy prescribed within 12 months.

NCQA .................................................

Contact Information: www.ncqa.org. 

PQRS, NCQA–PCMH 

Accreditation.

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

NQF 0047 ........... Title: Asthma Pharmacologic Therapy for Persistent Asthma ............

Description: Percentage of patients aged 5 through 50 years with a 

diagnosis of persistent asthma and at least one medical encounter for asthma during the measurement year who were prescribed 

long-term control medication.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

EHR PQRS, UDS ........ ............... Clinical Process/Effectiveness. 

NQF 0048 ........... Title: Osteoporosis: Management Following Fracture of Hip, Spine 

or Distal radius for Men and Women Aged 50 Years and Older.

Description: Percentage of patients aged 50 years or older with fracture of the hip, spine or distal radius that had a central dual-energy X-ray absorptiometry measurement ordered or performed or 

pharmacologic therapy prescribed.

NCQA .................................................

Contact Information: www.ncqa.org. 

PQRS ........................... New ...... Clinical Process/Effectiveness. 

NQF 0050 ........... Title: Osteoarthritis (OA): Function and Pain Assessment .................

Description: Percentage of patient visits for patients aged 21 years 

and older with a diagnosis of OA with assessment for function 

and pain.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS ........................... New ...... Patient and Family Engagement. 

NQF 0051 ........... Title: Osteoarthritis (OA): assessment for use of anti-inflammatory or 

analgesic over-the-counter (OTC) medications.

Description: Percentage of patient visits for patients aged 21 years 

and older with a diagnosis of OA with an assessment for use of 

anti-inflammatory or analgesic OTC medications.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org 

PQRS ........................... New ...... Clinical Process/Effectiveness. 

NQF 0052 ........... Title: Use of Imaging Studies for Low Back Pain ...............................

Description: Percentage of patients with a primary diagnosis of low 

back pain who did not have an imaging study (plain x-ray, MRI, 

CT scan) within 28 days of 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 (type 1 or type 2) who had a retinal or dilated eye exam or a 

negative retinal exam (no evidence of retinopathy) by an eye care 

professional.

NCQA .................................................

Contact Information: www.ncqa.org. 

EHR PQRS, Group Reporting PQRS................ Clinical Process/Effectiveness. 

NQF 0056 ........... Title: Diabetes: Foot Exam ..................................................................

Description: The percentage of patients aged 18–75 years with diabetes (type 1 or type 2) who had a foot exam (visual inspection, 

sensory exam with monofilament, or pulse exam).

NCQA .................................................

Contact Information: www.ncqa.org. 

EHR PQRS, Group Reporting PQRS................ Clinical Process/Effectiveness. 

NQF 0058 ........... Title: Avoidance of Antibiotic Treatment in Adults with Acute Bronchitis.

Description: Percentage of adults ages 18 through 64 years with a 

diagnosis of acute bronchitis who were not dispensed an antibiotic prescription on or within 3 days of the initial date of service.

NCQA .................................................

Contact Information: www.ncqa.org. 

PQRS ........................... New ...... Efficient Use of 

Healthcare Resources. 

NQF 0059 ........... Title: Diabetes: Hemoglobin A1c Poor Control ...................................

Description: Percentage of patients 18–75 years of age with diabetes (type 1 or type 2) who had hemoglobin A1c >9.0%.

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 pediatric patients with diabetes with an 

HbA1c test in a 12-month measurement period.

NCQA .................................................

Contact Information: www.ncqa.org. 

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

NQF 0061 ........... Title: Diabetes: Blood Pressure Management ....................................

Description: Percentage of patients 18–75 years of age with diabetes (type 1 or type 2) who had blood pressure <140/90 mmHg.

NCQA .................................................

Contact Information: www.ncqa.org. 

EHR PQRS, Group Reporting PQRS................ Clinical Process/Effectiveness. 

NQF 0062 ........... Title: Diabetes: Urine Screening ..........................................................

Description: Percentage of patients 18–75 years of age with diabetes (type 1 or type 2) who had a nephropathy screening test or 

evidence of nephropathy.

NCQA .................................................

Contact Information: www.ncqa.org. 

EHR PQRS, Group Reporting PQRS................ Clinical Process/Effectiveness. 

NQF 0064 ........... Title: Diabetes: Low Density Lipoprotein (LDL) Management and 

Control.

Description: Percentage of patients 18–75 years of age with diabetes (type 1 or type 2) who had LDL–C <100 mg/dL.

NCQA .................................................

Contact Information: www.ncqa.org. 

PQRS, Group Reporting PQRS................ Clinical Process/Effectiveness. 

NQF 0066 ........... Title: Coronary Artery Disease (CAD): Angiotensin-converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) 

Therapy¥Diabetes 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 diabetes OR a current or prior Left Ventricular 

Ejection Fraction (LVEF) <40% who were prescribed ACE inhibitor or ARB therapy.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

ACO, Group Reporting 

PQRS.

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

NQF 0067 ........... Title: Coronary Artery Disease (CAD): Antiplatelet Therapy ...............

Description: Percentage of patients aged 18 years and older with a 

diagnosis of coronary artery disease seen within a 12 month period who were prescribed aspirin or clopidogrel.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

EHR PQRS, Group Reporting PQRS................ Clinical Process/Effectiveness. 

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 13751 

TABLE 8—CLINICAL QUALITY MEASURES PROPOSED FOR MEDICARE AND MEDICAID ELIGIBLE PROFESSIONALS BEGINNING

WITH CY 2014—Continued 

Measure No. Clinical quality measure title & description Clinical quality measure steward & 

contact information 

Other quality measure 

programs that use the 

same measure** 

New 

measure Domain 

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 transluminal 

coronary angioplasty (PTCA) from January 1-November 1 of the 

year prior to the measurement year, or who had a diagnosis of 

ischemic vascular disease (IVD) during the measurement year 

and the year prior to the measurement year and who had documentation of use of aspirin or another antithrombotic during the 

measurement year.

NCQA .................................................

Contact Information: www.ncqa.org. 

EHR PQRS, ACO, 

Group Reporting 

PQRS.

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

NQF 0069 ........... Title: Appropriate Treatment for Children with Upper Respiratory Infection (URI).

Description: Percentage of children who were given a diagnosis of 

URI and were not dispensed an antibiotic prescription on or three 

days after the episode date.

NCQA .................................................

Contact Information: www.ncqa.org. 

PQRS, NCQA–PCMH 

Accreditation.

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 Accreditation.

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

NQF 0073 ........... Title: Ischemic Vascular Disease (IVD): Blood Pressure Management.

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 transluminal 

coronary angioplasty (PTCA) from January 1-November 1 of the 

year prior to the measurement year, or who had a diagnosis of 

ischemic vascular disease (IVD) during the measurement year 

and the year prior to the measurement year and whose recent 

blood pressure is in control (<140/90 mmHg).

NCQA .................................................

Contact Information: www.ncqa.org. 

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

NQF 0074 ........... Title: Coronary Artery Disease (CAD): Lipid Control ..........................

Description: Percentage of patients aged 18 years and older with a 

diagnosis of coronary artery disease seen within a 12 month period who have a LDL–C result <100mg/dL OR patients who have 

a LDL–C result ≥100mg/dL and have a documented plan of care 

to achieve LDL–C <100mg/dL, including at a minimum the prescription of a statin.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS, ACO, Group 

Reporting PQRS.

............... 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 transluminal 

angioplasty (PTCA) from January 1–November 1 of the year prior 

to the measurement year, or who had a diagnosis of ischemic 

vascular disease (IVD) during the measurement year and the year 

prior to the measurement year and who had a complete lipid profile performed during the measurement year and whose LDL– 

C<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).

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.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

EHR PQRS, Group Reporting PQRS, 

NCQA–PCMH Accreditation.

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

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 PROPOSALS2

13752 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 

TABLE 8—CLINICAL QUALITY MEASURES PROPOSED FOR MEDICARE AND MEDICAID ELIGIBLE PROFESSIONALS BEGINNING

WITH CY 2014—Continued 

Measure No. Clinical quality measure title & description Clinical quality measure steward & 

contact information 

Other quality measure 

programs that use the 

same measure** 

New 

measure Domain 

NQF 0097 ........... Title: Medication Reconciliation ...........................................................

Description: Percentage of patients aged 65 years and older discharged from any inpatient facility (e.g. hospital, skilled nursing facility, or rehabilitation facility) and seen within 60 days following 

discharge in the office by the physician providing on-going care 

who had a reconciliation of the discharge medications with the 

current medication list in the medical record documented.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org; NCQA Contact Information: www.ncqa.org.

ACO, Group Reporting 

PQRS, NCQA– 

PCMH Accreditation.

New ...... Patient Safety. 

NQF 0098 ........... Title: Urinary Incontinence: Assessment of Presence or Absence of 

Urinary Incontinence in Women Age 65 Years and Older.

Description: Percentage of female patients aged 65 years and older 

who were assessed for the presence or absence of urinary incontinence within 12 months.

NCQA .................................................

Contact Information: www.ncqa.org. 

PQRS ........................... New ...... Clinical Process/Effectiveness. 

NQF 0100 ........... Title: Urinary Incontinence: Plan of Care for Urinary Incontinence in 

Women Aged 65 Years and Older.

Description: Percentage of female patients aged 65 years and older 

with a diagnosis of urinary incontinence with a documented plan 

of care for urinary incontinence at least once within 12 months.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org; NCQA Contact Information: www.ncqa.org.

PQRS ........................... New ...... Patient and Family Engagement. 

NQF 0101 ........... Title: Falls: Screening for Falls Risk ....................................................

Description: Percentage of patients aged 65 years and older who 

were screened for future fall risk (patients are considered at risk 

for future falls if they have had 2 or more falls in the past year or 

any fall with injury in the past year) at least once within 12 

months.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org; NCQA Contact Information: www.ncqa.org.

PQRS, ACO, Group 

Reporting PQRS.

New ...... Patient Safety. 

NQF 0102 ........... Title: Chronic Obstructive Pulmonary Disease (COPD): Bronchodilator Therapy.

Description: Percentage of patients aged 18 years and older with a 

diagnosis of COPD and who have FEV1/FVC less than 70% and 

have symptoms who were prescribed an inhaled bronchodilator.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS, Group Reporting PQRS.New ...... Clinical Process/Effectiveness. 

NQF 0103 ........... Title: Major Depressive Disorder (MDD): Diagnostic Evaluation ........

Description: Percentage of patients aged 18 years and older with a 

new diagnosis or recurrent episode of MDD who met the DSM–IV 

criteria during the visit in which the new diagnosis or recurrent 

episode was identified during the measurement period.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS ........................... New ...... Clinical Process/Effectiveness. 

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: (a) Effective Acute 

Phase Treatment, (b) Effective Continuation Phase Treatment.

Description: The percentage of patients 18 years of age and older 

who were diagnosed with a new episode of major depression, 

treated with antidepressant medication, and who remained on an 

antidepressant medication treatment.

NCQA .................................................

Contact Information: www.ncqa.org. 

EHR PQRS, HEDIS, 

State use, ACA 2701.

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

NQF 0106 ........... Title: Diagnosis of attention deficit hyperactivity disorder (ADHD) in 

primary care for school age children and adolescents.

Description: Percentage of patients newly diagnosed with ADHD 

whose medical record contains documentation of DSM–IV–TR or 

DSM–PC criteria.

Institute for Clinical Systems Improvement (ICSI).

Contact Information: www.icsi.org .....

...................................... New ...... Care Coordination. 

NQF 0107 ........... Title: Management of attention deficit hyperactivity disorder (ADHD) 

in primary care for school age children and adolescents.

Description: Percentage of patients treated with psychostimulant 

medication for the diagnosis of ADHD whose medical record contains documentation of a follow-up visit at least twice a year.

ICSI ....................................................

Contact Information: www.icsi.org .....

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

NQF 0108 ........... Title: ADHD: Follow-Up Care for Children Prescribed Attention-Deficit/Hyperactivity Disorder (ADHD) Medication.

Description: (a) Initiation Phase: Percentage of children 6–12 years 

of age as of the Index Prescription Episode Start Date with an 

ambulatory prescription dispensed for ADHD medication and who 

had one follow-up visit with a practitioner with prescribing authority during the 30-Day Initiation Phase.

(b) Continuation and Maintenance (C&M) Phase: Percentage of children 6–12 years of age as of the Index Prescription Episode Start 

Date with an ambulatory prescription dispensed for ADHD medication who remained on the 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.

NCQA .................................................

Contact Information: www.ncqa.org. 

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

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 Accreditation.New ...... Clinical Process/Effectiveness. 

NQF 0112 ........... Title: Bipolar Disorder: Monitoring change in level-of-functioning .......

Description: Percentage of patients aged 18 years and older with an 

initial diagnosis or new episode/presentation of bipolar disorder.

CQAIMH .............................................

Contact Information: 

www.cqaimh.org; 

cqaimh@cqaimh.org.

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

NQF 0239 ........... Title: Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (when indicated in ALL patients).

Description: Percentage of patients aged 18 years and older undergoing procedures for which VTE prophylaxis is indicated in all patients, who had an order for Low Molecular Weight Heparin 

(LMWH), Low-Dose Unfractionated Heparin (LDUH), adjusteddose warfarin, fondaparinux or mechanical prophylaxis to be 

given within 24 hours prior to incision time or within 24 hours after 

surgery end time.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

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

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 13753 

TABLE 8—CLINICAL QUALITY MEASURES PROPOSED FOR MEDICARE AND MEDICAID ELIGIBLE PROFESSIONALS BEGINNING

WITH CY 2014—Continued 

Measure No. Clinical quality measure title & description Clinical quality measure steward & 

contact information 

Other quality measure 

programs that use the 

same measure** 

New 

measure Domain 

Formerly NQF 

0246, 

no longer endorsed. 

Title: Stroke and Stroke Rehabilitation: Computed Tomography (CT) 

or Magnetic Resonance Imaging (MRI) Reports.

Description: Percentage of final reports for CT or MRI studies of the 

brain performed either: 

• In the hospital within 24 hours of arrival, OR ..................................

• In an outpatient imaging center to confirm initial diagnosis of 

stroke, transient ischemic attack (TIA) or intracranial hemorrhage..

For patients aged 18 years and older with either a diagnosis of 

ischemic stroke, TIA or intracranial hemorrhage OR at least one 

documented symptom consistent with ischemic stroke, TIA or 

intracranial hemorrhage that includes documentation of the presence or absence of each of the following: hemorrhage, mass lesion and acute infarction.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org; NCQA Contact Information: www.ncqa.org.

PQRS ........................... New ...... Clinical Process/Effectiveness. 

NQF 0271 ........... Title: Perioperative Care: Discontinuation of Prophylactic Antibiotics 

(Non-Cardiac Procedures).

Description: Percentage of non-cardiac surgical patients aged 18 

years and older undergoing procedures with the indications for 

prophylactic parenteral antibiotics AND who received a prophylactic parenteral antibiotic, who have an order for discontinuation 

of prophylactic parenteral antibiotics within 24 hours of surgical 

end time.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS, NCQA–PCMH 

Accreditation.

New ...... Patient Safety. 

NQF 0312 ........... Title: Lower Back Pain: Repeat Imaging Studies ...............................

Description: Percentage of patients with back pain who received inappropriate imaging studies in the absence of red flags or progressive symptoms (overuse measure, lower performance is better).

NCQA .................................................

Contact Information: www.ncqa.org. 

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

Healthcare Resources. 

NQF 0321 ........... Title: Adult Kidney Disease: Peritoneal Dialysis Adequacy: Solute ....

Description: Percentage of patients aged 18 years and older with a 

diagnosis of ESRD receiving peritoneal dialysis who have a Kt/V≤ 

= 1.7 per week measured once every 4 months.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS ........................... New ...... Care Coordination. 

NQF 0322 ........... Title: Back Pain: Initial Visit 

Description: The percentage of patients with a diagnosis of back 

pain who have medical record documentation of all of the following on the date of the initial visit to the physician: 

1. Pain assessment .............................................................................

2. Functional status .............................................................................

3. Patient history, including notation of presence or absence of ‘‘red 

flags’’.

4. Assessment of prior treatment and response, and .........................

5. Employment status ..........................................................................

NCQA .................................................

Contact Information: www.ncqa.org. 

PQRS ........................... New ...... Efficient Use of 

Healthcare Resources. 

NQF 0323 ........... Title: Adult Kidney Disease: Hemodialysis Adequacy: Solute ............

Description: Percentage of calendar months within a 12-month period during which patients aged 18 years and older with a diagnosis of end-stage renal disease (ESRD) receiving hemodialysis 

three times a week have a spKt/V≥1.2.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS ........................... New ...... Care Coordination. 

NQF 0382 ........... Title: Oncology: Radiation Dose Limits to Normal Tissues .................

Description: Percentage of patients, regardless of age, with a diagnosis of pancreatic or lung cancer receiving 3D conformal radiation therapy with documentation in medical record that radiation 

dose limits to normal tissues were established prior to the initiation of a course of 3D conformal radiation for a minimum of two 

tissues.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org;.

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

NQF 0383 ........... Title: Oncology: Measure Pair: Oncology: Medical and Radiation— 

Plan of Care for Pain.

Description: Percentage of patient visits, regardless of patient age, 

with a diagnosis of cancer currently receiving chemotherapy or radiation therapy who report having pain with a documented plan of 

care to address pain.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS ........................... New ...... Patient and Family Engagement. 

NQF 0384 ........... Title: Oncology: Measure Pair: 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 Stage III Colon Cancer Patients.

Description: Percentage of patients aged 18 years and older with 

Stage IIIA through IIIC 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. 

NQF 0388 ........... Title: Prostate Cancer: Three Dimensional (3D) Radiotherapy ..........

Description: Percentage of patients, regardless of age, with a diagnosis of clinically localized prostate cancer receiving external 

beam radiotherapy as a primary therapy to the prostate with or 

without nodal irradiation (no metastases; no salvage therapy) who 

receive three-dimensional conformal radiotherapy (3D–CRT) or intensity modulated radiation therapy (IMRT).

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

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

mstockstill on DSK4VPTVN1PROD with PROPOSALS2

13754 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 

TABLE 8—CLINICAL QUALITY MEASURES PROPOSED FOR MEDICARE AND MEDICAID ELIGIBLE PROFESSIONALS BEGINNING

WITH CY 2014—Continued 

Measure No. Clinical quality measure title & description Clinical quality measure steward & 

contact information 

Other quality measure 

programs that use the 

same measure** 

New 

measure 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 0399 ........... Title: Hepatitis C: Hepatitis A Vaccination in Patients with HCV ........

Description: Percentage of patients aged 18 years and older with a 

diagnosis of hepatitis C who have received at least one injection 

of hepatitis A vaccine, or who have documented immunity to hepatitis A.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS, NCQA–PCMH 

Accreditation.

New ...... Population/Public 

Health. 

NQF 0400 ........... Title: Hepatitis C: Hepatitis B Vaccination in Patients with HCV ........

Description: Percentage of patients aged 18 years and older with a 

diagnosis of hepatitis C who have received at least one injection 

of hepatitis B vaccine, or who have documented immunity to hepatitis B.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS, NCQA–PCMH 

Accreditation.

New ...... Population/Public 

Health. 

NQF 0401 ........... Title: Hepatitis C: Counseling Regarding Risk of Alcohol Consumption.

Description: Percentage of patients aged 18 years and older with a 

diagnosis of hepatitis C who were counseled about the risks of alcohol use at least once within 12 months.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS, NCQA–PCMH 

Accreditation.

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

NQF 0403 ........... Title: Medical Visits ..............................................................................

Description: Percentage of patients regardless of age, with a diagnosis of HIV/AIDS with at least one medical visit in each 6 month 

period 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: Pneumocystitis jiroveci pneumonia (PCP) Prophylaxis ..............

Description: Percentage of patients with 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 

Accreditation.

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

NQF 0406 ........... Title: Patients with HIV/AIDS Who Are Prescribed Potent 

Antiretroviral Therapy.

Description: Percentage of patients who were prescribed potent 

antiretroviral therapy.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org; NCQA Contact Information: www.ncqa.org.

PQRS, NCQA–PCMH 

Accreditation.

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

NQF 0407 ........... Title: HIV RNA control after six months of potent antiretroviral therapy.

Description: Percentage of patients aged 13 years and older with a 

diagnosis of HIV/AIDS who had at least two medical visits during 

the measurement year, with at least 60 days between each visit, 

who are receiving potent antiretroviral therapy, who have a viral 

load below limits of quantification after at least 6 months of potent 

antiretroviral therapy OR whose viral load is not below limits of 

quantification after at least 6 months of potent antiretroviral therapy and has a documented plan of care.

NCQA .................................................

Contact Information: www.ncqa.org. 

PQRS ........................... New ...... Clinical Process/Effectiveness. 

NQF 0418 ........... Title: Screening for Clinical Depression ..............................................

Description: Percentage of patients aged 12 years and older 

screened for clinical depression using an age appropriate standardized tool and follow up plan documented.

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.usqualit

ymeasures.org.

EHR PQRS, ACO ........ New ...... Population/Public 

Health. 

NQF 0419 ........... Title: Documentation of Current Medications in the Medical Record

Description: Percentage of specified visits as defined by the denominator criteria 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, overthe-counters, herbals, vitamin/mineral/dietary (nutritional) supplements AND must contain the medications’ name, dosage, frequency and route.

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, 

Group Reporting 

PQRS.

New ...... Patient Safety. 

NQF 0421 ........... Title: Adult Weight Screening and Follow-Up .....................................

Description: Percentage of patients aged 18 years and older with a 

calculated body mass index (BMI) in the past six months or during the current visit documented in the medical record AND if the 

most recent BMI is outside of normal parameters, a follow-up plan 

is documented.

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 0507 ........... Title: Radiology: Stenosis Measurement in Carotid Imaging Studies

Description: Percentage of final reports for all patients, regardless of 

age, for carotid imaging studies (neck magnetic resonance 

angiography [MRA], neck computer tomography angiography 

[CTA], neck duplex ultrasound, carotid angiogram) performed that 

include direct or indirect reference to measurements of distal internal carotid diameter as the denominator for stenosis measurement.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS ........................... New ...... Clinical Process/Effectiveness. 

NQF 0508 ........... Title: Radiology: Inappropriate Use of ‘‘Probably Benign’’ Assessment Category in Mammography Screening.

Description: Percentage of final reports for screening mammograms 

that are classified as ‘‘probably benign.’’ 

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS ........................... New ...... Efficient Use of 

Healthcare Resources. 

NQF 0510 ........... Title: Radiology: Exposure Time Reported for Procedures Using Fluoroscopy.

Description: Percentage of final reports for procedures using fluoroscopy that include documentation of radiation exposure or exposure time.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

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

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WITH CY 2014—Continued 

Measure No. Clinical quality measure title & description Clinical quality measure steward & 

contact information 

Other quality measure 

programs that use the 

same measure** 

New 

measure Domain 

NQF 0513 ........... Title: Thorax CT: Use of Contrast Material .........................................

Description: This measure calculates the percentage of thorax studies that are performed with and without contrast out of all thorax 

studies performed (those with contrast, those without contrast, 

and those with both).

CMS ...................................................

Contact Information: 1–888–734– 

6433 or http://questions.cms.hhs.gov/app/ask/p/

21,26,1139.

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

Healthcare Resources. 

NQF 0519 ........... Title: Diabetic Foot Care and Patient/Caregiver Education Implemented During Short Term Episodes of Care.

Description: Percentage of short term home health episodes of care 

during which diabetic foot care and education were included in 

the physician-ordered plan of care and implemented for patients 

with diabetes.

CMS ...................................................

Contact Information: 1–888–734– 

6433 or http://questions.cms.hhs.gov/app/ask/p/

21,26,1139.

...................................... New ...... Care Coordination. 

NQF 0561 ........... Title: Melanoma: Coordination of Care ...............................................

Description: Percentage of patient visits, regardless of patient age, 

with a new occurrence of melanoma who have a treatment plan 

documented in the chart that was communicated to the physicians(s) providing continuing care within one month of diagnosis.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org; NCQA Contact Information: www.ncqa.org.

PQRS ........................... New ...... Care Coordination. 

NQF 0562 ........... Title: Melanoma: Overutilization of Imaging Studies in Melanoma .....

Description: Percentage of patients, regardless of age, with a current diagnosis of stage 0 through IIC melanoma or a history of 

melanoma of any stage, without signs or symptoms suggesting 

systemic spread, seen for an office visit during the one-year 

measurement period, for whom no diagnostic imaging studies 

were ordered.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org; NCQA Contact Information: www.ncqa.org.

PQRS ........................... New ...... Efficient Use of 

Healthcare Resources. 

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. 

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 0575 ........... Title: Diabetes: Hemoglobin A1c Control (<8.0%) ..............................

Description: The percentage of patients 18–75 years of age with diabetes (type 1 or type 2) who had hemoglobin A1c <8.0%.

NCQA .................................................

Contact Information: www.ncqa.org. 

EHR PQRS, Group Reporting PQRS, UDS................ 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 0711 ........... Title: Depression Remission at Six Months ........................................

Description: Adult patients age 18 and older with major depression 

or dysthymia and an initial PHQ–9 score >9 who demonstrate remission at six 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.

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. 

NQF 1335 ........... Title: Children who have dental decay or cavities ..............................

Description: Assesses if children aged 1–17 years have had tooth 

decay or cavities in the past 6 months.

Maternal and Child Health Bureau, 

Health Resources and Services 

Adminstration 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 documentation of a maternal depression screening 

for the mother.

NCQA .................................................

Contact Information: www.ncqa.org. 

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

Health. 

NQF 1419 ........... Title: Primary Caries Prevention Intervention as Part of Well/Ill Child 

Care as Offered by Primary Care Medical Providers.

Description: The measure will a) track the extent to which the 

PCMP or clinic (determined by the provider number used for billing) applies FV as part of the EPSDT examination and b) track 

the degree to which each billing entity’s use of the EPSDT with 

FV codes increases from year to year (more children varnished 

and more children receiving FV four times a year according to 

ADA recommendations for high-risk children).

University of Minnesota .....................

Contact Information: www.umn.edu ...

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

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WITH CY 2014—Continued 

Measure No. Clinical quality measure title & description Clinical quality measure steward & 

contact information 

Other quality measure 

programs that use the 

same measure** 

New 

measure Domain 

NQF 1525 ........... Title: Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation 

Therapy.

Description: Percentage of patients aged 18 years and older with 

nonvalvular AF or atrial flutter at high risk for thromboembolism, 

according to CHADS2 risk stratification, who were prescribed warfarin or another oral anticoagulant drug that is FDA approved for 

the prevention of thromboembolism during the 12-month reporting 

period.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org; American College of Cardiology Foundation (ACCF) www.

cardiosource.org; American Heart 

Association (AHA) www.heart.org.

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

TBD .................... Title: Preventive Care and Screening: Cholesterol—Fasting Low 

Density Lipoprotein (LDL) Test Performed AND Risk-Stratified 

Fasting LDL.

Description: Percentage of patients aged 20 through 79 years 

whose risk factors* have been assessed and a fasting LDL test 

has been performed. Percentage of patients aged 20 through 79 

years who had a fasting LDL test performed and whose riskstratified* fasting LDL is at or below the recommended LDL goal.

CMS ...................................................

1–888–734–6433 or http://questions.cms.hhs.gov/app/ask/p/

21,26,1139; QIP Contact Information: www.usqualitymeasures.org.

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

TBD .................... Title: Falls: Risk Assessment for Falls ................................................

Description: Percentage of patients aged 65 years and older with a 

history of falls who had a risk assessment for falls completed 

within 12 months.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org; NCQA Contact Information: www.ncqa.org.

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

TBD .................... Title: Falls: Plan of Care for Falls ........................................................

Description: Percentage of patients aged 65 years and older with a 

history of falls who had a plan of care for falls documented within 

12 months.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org; NCQA Contact Information: www.ncqa.org.

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

TBD .................... Title: Adult Kidney Disease: Blood Pressure Management ................

Description: Percentage of patient visits for those patients aged 18 

years and older with a diagnosis of CKD (stage 3, 4, or 5 not receiving RRT) and proteinuria with a blood pressure <130/80 

mmHg or ≥130/80 mmHg with documented plan of care.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

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

TBD .................... Title: Adult Kidney Disease: Patients on Erythropoiesis Stimulating 

Agent (ESA)-Hemoglobin Level >12.0 g/dL.

Description: Percentage of calendar months within a 12-month period during which a hemoglobin (Hgb) level is measured for patients aged 18 years and older with a diagnosis of advanced CKD 

(stage 4 or 5, not receiving RRT) or end-stage renal disease 

(ESRD) (who are on hemodialysis or peritoneal dialysis) who are 

also receiving ESA therapy have a hemoglobin (Hgb) level >12.0 

g/dL.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

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

Healthcare Resources. 

TBD .................... Title: Chronic Wound Care: Use of wet to dry dressings in patients 

with chronic skin ulcers (overuse measure).

Description: Percentage of patient visits for those patients aged 18 

years and older with a diagnosis of chronic skin ulcer without a 

prescription or recommendation to use wet to dry dressings.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org; NCQA Contact Information: www.ncqa.org.

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

TBD .................... Title: Dementia: Staging of Dementia .................................................

Description: Percentage of patients, regardless of age, with a diagnosis of dementia whose severity of dementia was classified as 

mild, moderate, or severe at least once within a 12 month period.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

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. 

TBD .................... Title: Dementia: Functional Status Assessment ..................................

Description: Percentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of functional status is 

performed and the results reviewed at least once within a 12 

month period.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS ........................... New ...... Patient and Family Engagement. 

TBD .................... Title: Dementia: Counseling Regarding Safety Concerns ...................

Description: Percentage of patients, regardless of age, with a diagnosis of dementia or their caregiver(s) who were counseled or referred for counseling regarding safety concerns within a 12 month 

period.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS ........................... New ...... Patient and Family Engagement. 

TBD .................... Title: Dementia: Counseling Regarding Risks of Driving ....................

Description: Percentage of patients, regardless of age, with a diagnosis of dementia or their caregiver(s) who were counseled regarding the risks of driving and the alternatives to driving at least 

once within a 12 month period.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

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

TBD .................... Title: Dementia: Caregiver Education and Support .............................

Description: Percentage of patients, regardless of age, with a diagnosis of dementia whose caregiver(s) were provided with education on dementia disease management and health behavior 

changes AND referred to additional resources for support within a 

12-month period.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

PQRS ........................... New ...... Patient and Family Engagement. 

TBD .................... Title: Chronic Wound Care: Patient education regarding long term 

compression therapy.

Description: Percentage of patients aged 18 years and older with a 

diagnosis of venous ulcer who received education regarding the 

need for long term compression therapy including interval replacement of compression stockings within the 12 month reporting period.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org; NCQA Contact Information: www.ncqa.org.

...................................... New ...... Patient and Family Engagement. 

TBD .................... Title: Rheumatoid Arthritis (RA): Functional Status Assessment ........

Description: Percentage of patients aged 18 years and older with a 

diagnosis of RA for whom a functional status assessment was 

performed at least once within 12 months.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org; NCQA Contact Information: www.ncqa.org.

PQRS ........................... New ...... Patient and Family Engagement. 

TBD .................... Title: Glaucoma Screening in Older Adults .........................................

Description: Percentage of patients 65 years and older, without a 

prior diagnosis of glaucoma or glaucoma suspect, who received a 

glaucoma eye exam by an eye-care professional for early identification of glaucomatous conditions.

NCQA .................................................

Contact Information: www.ncqa.org. 

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

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TABLE 8—CLINICAL QUALITY MEASURES PROPOSED FOR MEDICARE AND MEDICAID ELIGIBLE PROFESSIONALS BEGINNING

WITH CY 2014—Continued 

Measure No. Clinical quality measure title & description Clinical quality measure steward & contact information 

Other quality measure 

programs that use the same measure** 

New 

measure Domain 

TBD .................... Title: Chronic Wound Care: Patient Education regarding diabetic 

foot care.

Description: Percentage of patients aged 18 years and older with a 

diagnosis of diabetes and foot ulcer who received education regarding appropriate foot care AND daily inspection of the feet 

within the 12 month reporting period.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org; NCQA Contact Information: www.ncqa.org.

...................................... New ...... Patient and Family Engagement. 

TBD .................... Title: Hypertension: Improvement in blood pressure ..........................

Description: Percentage of patients aged 18 years and older with 

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 regardless of age with a referral 

from a primary care provider for whom a report from the provider 

to whom the patient was referred was received by the referring 

provider.

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 and two or more high impact conditions 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: Adverse Drug Event (ADE) Prevention: Outpatient therapeutic 

drug monitoring.

Description: Percentage of patients 18 years of age and older receiving outpatient chronic medication therapy who had the appropriate therapeutic drug monitoring during the measurement year.

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.

Description: Percentage of patients aged 18 years and older who 

are screened for high blood pressure.

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, Group Reporting PQRS, ACO.New ...... Population/Public 

Health. 

TBD .................... Title: Hypertension: Blood Pressure Management ..............................

Description: Percentage of patients aged 18 years and older with a 

diagnosis of hypertension seen within a 12 month period with a 

blood pressure <140/90mmHg OR patients with a blood pressure 

≥140/90mmHg and prescribed 2 or more anti-hypertensive medications during the most recent office visit.

AMA–PCPI .........................................

Contact Information: cpe@amaassn.org.

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

** 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. Proposed Reporting Methods for 

Clinical Quality Measures for Eligible 

Professionals 

(a) Proposed Reporting Methods for 

Medicaid EPs 

For Medicaid EPs, 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 allow reporting 

through attestation. If a State does 

require such electronic reporting, the 

State is responsible for sharing the 

details on the process with its provider 

community. We anticipate that 

whatever means States have deployed 

for capturing Stage 1 clinical quality 

measures 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, the 

States will establish the method and 

requirements, subject to CMS prior 

approval, for electronically reporting. 

(b) Proposed Reporting Methods for 

Medicare EPs in CY 2013 

In the CY 2012 Medicare Physician 

Fee Schedule final rule, we established 

a pilot program for Medicare EPs for CY 

2012 that is intended to test and 

demonstrate our capacity to accept 

electronic reporting of Stage 1 clinical 

quality measure data (76 FR 73422 

through 73425). The title of this pilot 

program is the Physician Quality 

Reporting System—Medicare EHR 

Incentive Pilot, and it capitalizes on 

existing quality measures reporting 

infrastructure. The EHR Incentive 

Program Registration and Attestation 

System is located at https:// 

ehrincentives.cms.gov/hitech/ 

login.action. 

(c) Proposed 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 clinical quality measures selected by 

the Secretary ‘‘in a form and manner 

specified by the Secretary’’ as part of 

demonstrating meaningful use of 

Certified EHR Technology. As discussed 

in section II.B.4.b. of this proposed rule, 

Medicare EPs who are in their first year 

of Stage 1 may report clinical quality 

measures through attestation for a 

continuous 90-day EHR reporting period 

(for an explanation of reporting through 

attestation, see the discussion in the 

Stage 1 final rule (75 FR 44430 through 

44431)). 

Medicare EPs who choose to report 12 

clinical quality measures as described in 

Options 1.a. and 1.b. in section II.B.4.c. 

of this proposed rule would submit 

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through an aggregate reporting method, 

which would require the EP to log into 

a CMS-designated portal. Once the EP 

has logged into the portal, they would 

be required to submit through an upload 

process, data produced as output from 

their Certified EHR Technology in an 

XML-based format specified by CMS. 

We are considering an ‘‘interim 

submission’’ option for Medicare EPs 

who are in their first year of Stage 1 and 

who participate in the Physician Quality 

Reporting System. Under this option, 

EPs would submit the Physician Quality 

Reporting System clinical quality 

measures 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. The EP would report 

the remainder of his/her clinical quality 

measures data by the deadline specified 

for the Physician Quality Reporting 

System to meet the requirements of the 

Physician Quality Reporting System. We 

request public comment on this 

potential option. Medicare EPs who are 

beyond their first year of Stage 1 and 

who choose the Physician Quality 

Reporting System EHR reporting option 

(Option 2 in section II.B.4.(c). of this 

proposed rule) must report in the form 

and manner specified for the Physician 

Quality Reporting System (for more 

information on current reporting 

requirements, see the CY 2012 Medicare 

Physician Fee Schedule final rule with 

comment period (76 FR 73314)). 

(d) Group Reporting Option for 

Medicare and Medicaid Eligible 

Professionals Beginning With CY 2014 

For Stage 1, EPs were required to 

report the clinical quality measures on 

an individual basis and did not have an 

option to report the measures 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 eligible professionals 

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 are proposing three group 

reporting options to allow eligible 

professionals within a single group 

practice to report clinical quality 

measure data on a group level. All three 

methods would be available for 

Medicare EPs, while only the first one 

would be possible for Medicaid EPs, at 

States’ discretion. 

We are proposing each of these 

options as an alternative to reporting 

clinical quality measure data as an 

individual eligible professional under 

the proposed options and reporting 

methods discussed earlier in this rule. 

These group reporting options would 

only be available for reporting clinical 

quality measures 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 propose for EPs are as follows: 

• Two or more EPs, each identified 

with a unique NPI associated with a 

group practice identified under one tax 

identification number (TIN) may be 

considered an EHR Incentive Group for 

the purposes of reporting clinical 

quality measures for the Medicare EHR 

Incentive Program. This group reporting 

option is only available for electronic 

reporting of clinical quality measures 

and is not available for those EPs in 

their first year of Stage 1. The clinical 

quality measures reported under this 

option would represent all EPs within 

the group. EPs who choose this group 

reporting option for clinical quality 

measures must still individually satisfy 

the objectives and associated measures 

for their respective stage of meaningful 

use. CMS proposes that States may also 

choose this option to accept group 

reporting for clinical quality measures, 

based upon a pre-determined definition 

of a ‘‘group practice,’’ such as sharing 

one TIN. 

• Medicare EPs participating in the 

Medicare Shared Savings Program and 

the testing of the Pioneer Accountable 

Care Organization (ACO) model who 

use Certified EHR Technology to submit 

ACO measures in accordance with the 

requirements of the Medicare Shared 

Savings Program would be considered 

to have satisfied their clinical quality 

measures reporting requirement as a 

group for the Medicare EHR Incentive 

Program. The Medicare Shared Savings 

Program does not require the use of 

Certified EHR Technology. However, all 

clinical quality measures data must be 

extracted from Certified EHR 

Technology in order for the EP to 

qualify for the Medicare EHR Incentive 

Program if an EP intends to use this 

group reporting option. EPs must still 

individually satisfy the objectives and 

associated measures for their respective 

stage of meaningful use, in addition to 

submitting clinical quality measures as 

part of an ACO. EPs who are part of an 

ACO but do not enter the data used for 

reporting the clinical quality measures 

(which excludes the survey tool or 

claims-based measures that are collected 

to calculate the quality performance 

score in the Medicare Shared Savings 

Program) into Certified EHR Technology 

would not be able to meet meaningful 

use requirements. (For more information 

about the requirements of the Medicare 

Shared Savings Program, see 42 CFR 

part 425 and the final rule published at 

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 Shared Savings Program that 

may apply in the future. EPs must be 

part of a group practice (that is, two or 

more eligible professionals, 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 Physician Quality Reporting 

System clinical quality measures using 

Certified EHR Technology under the 

Physician Quality Reporting System 

Group Practice Reporting Option, would 

be considered to have satisfied their 

clinical quality measures reporting 

requirement as a group for the Medicare 

EHR Incentive Program. For more 

information about the Physician Quality 

Reporting System Group Practice 

Reporting Option, see 42 CFR 414.90 

and the CY 2012 Medicare Physician 

Fee Schedule final rule (76 FR 73314). 

EPs who use this group reporting option 

for the Medicare EHR Incentive Program 

would be required to comply with any 

changes to the Physician Quality 

Reporting System Group Practice 

Reporting Option that may apply in the 

future and must still individually satisfy 

the objectives and associated measures 

for their respective stage of meaningful 

use. 

States would have the option to allow 

group reporting of clinical quality 

measures based upon the first option 

previously described, through an update 

to their State Medicaid HIT Plan, and 

would have to address how they would 

address the issue of EPs who switch 

group practices during an EHR reporting 

period. 

7. Proposed Clinical Quality Measures 

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 clinical quality measures by 

eligible hospitals and CAHs as part of 

demonstrating meaningful use of 

Certified EHR Technology. 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). 

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Section 1886(n)(3)(B)(i)(I) of the Act 

requires the Secretary to give preference 

to clinical quality measures 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) (namely, the NQF). We 

are proposing clinical quality measures 

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 measures for the EHR Incentive 

Programs. Measures listed in this 

proposed 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 Certified EHR 

Technology under Medicare and 

Medicaid. Therefore, to meet this 

requirement, we continue our practice 

from Stage 1 of proposing clinical 

quality measures that would apply for 

both the Medicare and Medicaid EHR 

Incentive Programs, as listed in sections 

II.B.6.(b). and II.B.6.(c). of this proposed 

rule. 

In accordance with CMS and HHS 

quality goals as well as the HHS 

National Quality Strategy 

recommendations, the hospital clinical 

quality measures that we are proposing 

beginning with FY 2014 can be 

categorized into the following six 

domains, which are described in section 

II.B.3. of this proposed rule: 

• Clinical Process/Effectiveness. 

• Patient Safety. 

• Care Coordination. 

• Efficient Use of Healthcare 

Resources. 

• Patient & Family Engagement. 

• Population & Public Health. 

The selection of clinical quality 

measures we are proposing 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 Program 

and Hospital Value-Based Purchasing 

Program, the National Quality Strategy, 

and other considerations discussed in 

sections II.B.6.(b). and II.B.6.(c). of this 

proposed rule. The proposed reporting 

methods for Medicare eligible hospitals 

and CAHs are described in sections 

II.B.7.(a). and II.B.7.(b). of this proposed 

rule. The proposed reporting methods 

for Medicaid-only eligible hospitals are 

described in section II.B.7.(c). of this 

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 have analyzed 

the Hospital IQR Program, hospital 

measures used by State Medicaid 

agencies, and the Joint Commission’s 

hospital quality measures when 

selecting the measures to be reported 

under the EHR Incentive Program. 

Furthermore, we have placed emphasis 

on those measures that are in line with 

the National Quality Strategy and the 

HITPC’s recommendations. 

(b) Proposed Clinical Quality Measures 

for Eligible Hospitals and CAHs for FY 

2013 

For the EHR reporting periods in FY 

2013, we propose that the eligible 

hospitals and CAHs would be required 

to submit information on each of the 15 

clinical quality measures that were 

finalized for FYs 2011 and 2012 in the 

Stage 1 final rule (75 FR 44418 through 

44420, Table 10). We refer readers to the 

discussion in the Stage 1 final rule for 

further explanation of the requirements 

for reporting those clinical quality 

measures (75 FR 44411 through 44422). 

(c) Clinical Quality Measures Proposed 

for Eligible Hospitals and CAHs 

Beginning With FY 2014 

We are proposing to change the 

reporting requirement beginning with 

FY 2014 to require eligible hospitals and 

CAHs to report 24 clinical quality 

measures from a menu of 49 clinical 

quality measures, including at least 1 

clinical quality measure from each of 

the 6 domains. The 49 clinical quality 

measures would include the current set 

of 15 clinical quality measures that were 

finalized for FYs 2011 and 2012 in the 

Stage 1 final rule as well as additional 

pediatric measures, an obstetric 

measure, and cardiac measures. 

Our experience from Stage 1 in 

implementing the current set of 15 

clinical quality measures in specialty 

and low volume eligible hospitals has 

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 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 clinical quality 

measures for stroke and VTE. We are 

considering 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 measures. 

Hospitals that do not have enough cases 

to exceed the threshold would be 

exempt from reporting certain clinical 

quality measures. We solicit 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 

clinical quality measures (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 ‘‘zeros’’ for the 

measures). We are also soliciting 

comment 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 more narrow patient base than 

acute care and critical access hospitals. 

Comments are solicited for application 

of the thresholds to Stage 1 of 

meaningful use in 2013, as the issue 

would be mitigated for Stages 1 and 2 

by a beginning in 2014 proposed menu 

set of hospital clinical quality measures. 

Aside from the previous threshold 

discussion, we are proposing clinical 

quality measures in Table 9 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. 

We propose that eligible hospitals and 

CAHs must report a total of 24 clinical 

quality measures from those listed in 

Table 9. Eligible hospitals and CAHs 

would have to select and report at least 

1 measure from each of the following 6 

domains: 

• Patient and Family Engagement. 

• Patient Safety. 

• Care Coordination. 

• Population and Public Health. 

• Efficient Use of Healthcare 

Resources. 

• Clinical Process/Effectiveness. 

For the remaining clinical quality 

measures, eligible hospitals and CAHs 

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would select and report the measures 

from Table 9 that best apply to their 

patient mix. We are soliciting comment 

on the number of measures and the 

appropriateness of the measures and 

domains for eligible hospitals and 

CAHs. 

If an eligible hospital’s or CAH’s 

Certified EHR Technology does not 

contain patient data for at least 24 

measures, including a minimum of at 

least 1 from each domain, then the 

eligible hospital or CAH must report the 

measures for which there is patient data 

and report the remaining required 

measures as ‘‘zero denominators’’ 

through the form and manner specified 

by the Secretary. In the unlikely event 

that there are no measures applicable to 

the eligible hospital’s or CAH’s patient 

mix, eligible hospitals or CAHs must 

still report 24 measures even if zero is 

the result in either the numerator or the 

denominator of the measure. If all 

measures have a value of zero from their 

Certified EHR Technology, then eligible 

hospitals or CAHs must report any 24 of 

the measures. 

In the Stage 1 final rule (75 FR 44418), 

the title for the clinical quality measure 

NQF #438 was listed as ‘‘Ischemic or 

hemorrhagic stroke—Antithrombotic 

therapy by day 2.’’ The corrected 

measure title, which is also included in 

Table 9 is ‘‘Stroke-5 Ischemic stroke— 

Antithrombotic therapy by day 2.’’ 

Table 9 lists all of the clinical quality 

measures that we are proposing for 

eligible hospitals and CAHs to report for 

the EHR Incentive Programs beginning 

with FY 2014. The measures titles and 

descriptions in Table 9 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. Measures which are 

designated as ‘‘New’’ in the ‘‘New 

Measures’’ column were not finalized in 

the Stage 1 final rule. Some of the 

clinical quality measures in this table 

will require the development of 

electronic specifications. Therefore, we 

propose to consider these clinical 

quality measures for possible inclusion 

beginning with FY 2014 based on our 

expectation that their electronic 

specifications will be available at the 

time of or within a reasonable period 

the publication of the final rule. All 

clinical quality measure specification 

updates, including a schedule for 

updates to electronic specifications, 

would be posted on the EHR Incentive 

Program Web site (https://www.cms.gov/ 

QualityMeasures/ 

03_ElectronicSpecifications.asp), and 

we would notify the public. 

Additionally, some of these measures 

have been submitted by the measure 

steward and are currently under review 

for endorsement consideration by the 

National Quality Forum. The finalized 

list of clinical quality measures that 

would apply for eligible hospitals and 

CAHs beginning with FY 2014 will be 

published in the final rule. 

TABLE 9—CLINICAL QUALITY MEASURES PROPOSED FOR ELIGIBLE HOSPITALS AND CRITICAL ACCESS HOSPITALS

BEGINNING WITH FY 2014 

NQF # Title Measure steward and contact 

information 

Other quality measure 

programs that use the 

same measure *** 

New 

measure 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..

Oklahoma Foundation for Medical 

Quality (OFMQ) www.ofmq.com 

and click on ‘‘Contact’’.

IQR ................................ Patient and Family Engagement. 

0497 ................... Title: ED-2 Emergency Department Throughput—admitted patients— 

Admit decision time to ED departure time for admitted patients.

Description: Median time from admit decision time to time of departure from the emergency department for emergency department patients admitted to inpatient status.

Oklahoma Foundation for Medical 

Quality (OFMQ) www.ofmq.com 

and click on ‘‘Contact’’.

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.joint

commission.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. 

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TABLE 9—CLINICAL QUALITY MEASURES PROPOSED FOR ELIGIBLE HOSPITALS AND CRITICAL ACCESS HOSPITALS

BEGINNING WITH FY 2014—Continued 

NQF # Title Measure steward and contact 

information 

Other quality measure 

programs that use the 

same measure *** 

New 

measure 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 Overlap of Anticoagulation Therapy ....

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. Overlap 

therapy must be administered for at least five days with an international normalized ratio (INR) = 2 prior to discontinuation of the 

parenteral anticoagulation therapy or the patient must be discharged on both medications.

The Joint Commission www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR ................................ New ....... Clinical Process/Effectiveness. 

0374 ................... Title: VTE Patients Unfractionated Heparin (UFH) Dosages/Platelet 

Count Monitoring by Protocol (or Nomogram) Receiving Unfractionated Heparin (UFH) with Dosages/Platelet Count Monitored 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, to home 

with home health, or home hospice 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 on arrival) 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. 

0132 ................... Title: AMI-1-Aspirin at arrival for acute myocardial infarction (AMI) ......

Description: Percentage of acute myocardial infarction (AMI) patients 

without aspirin contraindications who received aspirin within 24 

hours before or after hospital arrival.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR, TJC ....................... New ....... Clinical Process/Effectiveness. 

0142 ................... Title: AMI-2-Aspirin Prescribed at Discharge for AMI ............................

Description: Percentage of acute myocardial infarction (AMI) patients 

without aspirin contraindications who are prescribed aspirin at hospital discharge.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR ................................ New ....... Clinical Process/Effectiveness. 

0469 ................... Title: Elective Delivery Prior to 39 Completed Weeks Gestation ..........

Description: Percentage of babies electively delivered prior to 39 

completed weeks gestation.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

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

0137 ................... Title: AMI-3-ACEI or ARB for Left Ventricular Systolic DysfunctionAcute Myocardial Infarction (AMI) Patients.

Description: Percentage of acute myocardial infarction (AMI) patients 

with left ventricular systolic dysfunction (LVSD) and without both 

Angiotensin converting enzyme inhibitor (ACEI) and Angiotensin receptor blocker (ARB) contraindications who are prescribed an ACEI 

or ARB at hospital discharge. For purposes of this measure, LVSD 

is defined as chart documentation of a left ventricular ejection fraction (LVEF) less than 40% or a narrative description of left ventricular systolic (LVS) function consistent with moderate or severe systolic dysfunction.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR ................................ New ....... Clinical Process/Effectiveness. 

0160 ................... Title: AMI-5-Beta Blocker Prescribed at Discharge for AMI ..................

Description: Percentage of acute myocardial infarction (AMI) patients 

without beta blocker contraindications who are prescribed a beta 

blocker at hospital discharge.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR ................................ New ....... Clinical Process/Effectiveness. 

0164 ................... Title: AMI-7a-Fibrinolytic Therapy received within 30 minutes of hospital arrival.

Description: Percentage of acute myocardial infarction (AMI) patients 

receiving fibrinolytic therapy during the hospital stay and having a 

time from hospital arrival to fibrinolysis of 30 minutes or less.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR, HVBP .................... New ....... Clinical Process/Effectiveness. 

0163 ................... Title: AMI-8a-Primary Percutaneous Coronary Intervention (PCI) ........

Description: Percentage of acute myocardial infarction (AMI) patients 

receiving percutaneous coronary intervention (PCI) during the hospital stay with a time from hospital arrival to PCI of 90 minutes or 

less.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR, HVBP .................... New ....... Clinical Process/Effectiveness. 

0639 ................... Title: AMI-10 Statin Prescribed at Discharge ........................................

Description: Percent of acute myocardial infarction (AMI) patients 18 

years of age or older who are prescribed a statin medication at 

hospital discharge.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR ................................ New ....... Clinical Process/Effectiveness. 

0148 ................... Title: PN-3b-Blood Cultures Performed in the Emergency Department 

Prior to Initial Antibiotic Received in Hospital.

Description: Percentage of pneumonia patients 18 years of age and 

older who have had blood cultures performed in the emergency department prior to initial antibiotic received in hospital.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR, HVBP .................... New ....... Efficient Use of 

Healthcare Resources. 

0147 ................... Title: PN-6-Initial Antibiotic Selection for Community-Acquired Pneumonia (CAP) in Immunocompetent Patients.

Description: Percentage of pneumonia patients 18 years of age or 

older selected for initial receipts of antibiotics for community-acquired pneumonia (CAP).

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR, HVBP .................... New ....... Efficient Use of 

Healthcare Resources. 

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TABLE 9—CLINICAL QUALITY MEASURES PROPOSED FOR ELIGIBLE HOSPITALS AND CRITICAL ACCESS HOSPITALS

BEGINNING WITH FY 2014—Continued 

NQF # Title Measure steward and contact 

information 

Other quality measure 

programs that use the 

same measure *** 

New 

measure Domain 

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.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

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).

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR, HVBP .................... New ....... Efficient Use of 

Healthcare Resources. 

0529 ................... Title: SCIP-INF-3-Prophylactic Antibiotics Discontinued Within 24 

Hours After Surgery End Time.

Description: Surgical patients whose prophylactic antibiotics were discontinued within 24 hours after Anesthesia End Time. The Society 

of Thoracic Surgeons (STS) Practice Guideline for Antibiotic Prophylaxis in Cardiac Surgery (2006) indicates that there is no reason 

to extend antibiotics beyond 48 hours for cardiac surgery and very 

explicitly states that antibiotics should not be extended beyond 48 

hours even with tubes and drains in place for cardiac surgery.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR, HVBP, State use .. New ....... Efficient Use of 

Healthcare Resources. 

0300 ................... Title: SCIP-INF-4-Cardiac Patients with Controlled 6 AM Postoperative Serum Glucose.

Description: Percentage of cardiac surgery patients with controlled 6 

a.m. serum glucose (</=200 mg/dl) on postoperative day (POD) 1 

and POD 2.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR, HVBP .................... New ....... Clinical Process/Effectiveness. 

0301 ................... Title: SCIP-INF-6-Surgery patients with appropriate hair removal ........

Description: Percentage of surgery patients with surgical hair site removal with clippers or depilatory or no surgical hair site removal.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR ................................ New ....... Patient Safety. 

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.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR, TJC ....................... New ....... Patient Safety. 

0136 ................... Title: HF-1 Heart Failure (HF): Detailed Discharge Instructions ...........

Description: Percentage of heart failure patients discharged home 

with written instructions or educational material given to patient or 

caregiver at discharge or during the hospital stay addressing all of 

the following: Activity level, diet, discharge medications, follow-up 

appointment, weight monitoring, and what to do if symptoms worsen.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR, HVBP .................... New ....... Patient & Family Engagement. 

0434 ................... Title: Stroke-1 Venous Thromboembolism (VTE) Prophylaxis ..............

Description: Ischemic or a hemorrhagic stroke patients who received 

VTE prophylaxis or have documentation why no VTE prophylaxis 

was given the day of or the day after hospital admission.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR ................................ New ....... Patient Safety. 

0284 ................... Title: SCIP-Card-2 Surgery Patients on a Beta Blocker Therapy Prior 

to Admission Who Received a Beta Blocker During the 

Perioperative Period.

Description: Percentage of patients on beta blocker therapy prior to 

admission who received a beta blocker during the perioperative period.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR, HVBP .................... New ....... Clinical Process/Effectiveness. 

0218 ................... Title: SCIP-VTE-2 Surgery Patients Who Received Appropriate Venous Thromboembolism (VTE) Prophylaxis Within 24 hours Prior to 

Surgery to 24 Hours After Surgery End Time.

Description: Percentage of surgery patients who received appropriate 

Venous Thromboembolism (VTE) prophylaxis within 24 hours prior 

to surgery to 24 hours after surgery end time.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

IQR, HVBP .................... New ....... Patient Safety. 

0496 ................... Title: ED-3 Description: 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.

Oklahoma Foundation for Medical 

Quality (OFMQ) www.ofmq.com 

and click on ‘‘Contact’’.

OQR .............................. New ....... Care Coordination. 

0338 ................... Title: Home Management Plan of Care Document Given to Patient/ 

Caregiver.

Description: Documentation exists that the Home Management Plan 

of Care (HMPC) as a separate document, specific to the patient, 

was given to the patient/caregiver, prior to or upon discharge.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

State use ....................... New ....... Patient & Family Engagement. 

0341 ................... Title: PICU Pain Assessment on Admission ..........................................

Description: Percentage of PICU patients receiving: a. Pain assessment on admission, b. Periodic pain assessment.

National Association of Children’s 

Hospitals and Related Institutions (NACHRI) www.nachri.org 

and click on ‘‘Contact Us’’.

State use ....................... New ....... Patient & Family Engagement. 

0342 ................... Title: PICU Periodic Pain Assessment ..................................................

Description: Percentage of PICU patients receiving: a. Pain assessment on admission, b. Periodic pain assessment.

National Association of Children’s 

Hospitals and Related Institutions (NACHRI) www.nachri.org 

and click on ‘‘Contact Us’’.

State use ....................... New ....... Patient & Family Engagement. 

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Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 13763 

TABLE 9—CLINICAL QUALITY MEASURES PROPOSED FOR ELIGIBLE HOSPITALS AND CRITICAL ACCESS HOSPITALS

BEGINNING WITH FY 2014—Continued 

NQF # Title Measure steward and contact 

information 

Other quality measure 

programs that use the 

same measure *** 

New 

measure Domain 

0480 ................... Title: Exclusive Breastfeeding at Hospital Discharge ............................

Description: Exclusive Breastfeeding (BF) for the first 6 months of 

neonatal life has long been the expressed goal of WHO, DHHS, 

APA, and ACOG. ACOG has recently reiterated its position (ACOG 

2007). A recent Cochrane review substantiates the benefits (Kramer, 2002). Much evidence has now focused on the prenatal and 

intrapartum period as critical for the success of exclusive (or any) 

BF (Shealy, 2005; Taveras, 2004; Petrova, 2007; CDC-MMWR, 

2007). Exclusive Breastfeeding rate during birth hospital stay has 

been calculated by the California Department of Public Health for 

the last several years using newborn genetic disease testing data. 

HP2010 and the CDC have also been active in promoting this 

measure. Holding prenatal and intrapartum providers accountable 

is an important way to incent greater efforts during the critical prenatal and immediate postpartum periods where BF attitudes are solidified.

California Maternal Quality Care 

Collaborative www.cmqcc.org 

and click on ‘‘Contact Us’’.

State use ....................... New ....... Clinical Process/Effectiveness. 

0481 ................... Title: First temperature measured within one hour of admission to the 

NICU.

Description: Percent of NICU admissions with a birth weight of 501– 

1500g with a first temperature taken within 1 hour of NICU admission.

Vermont Oxford Network www.

vtoxford.org and click on ‘‘Contact Us’’.

State use ....................... New ....... Clinical Process/Effectiveness. 

0482 ................... Title: First NICU Temperature < 36 degrees C .....................................

Description: Percent of all NICU admissions with a birth weight of 

501–1500g whose first temperature was measured within one hour 

of admission to the NICU and was below 36 degrees Centigrade.

Vermont Oxford Network www.

vtoxford.org and click on ‘‘Contact Us’’.

State use ....................... New ....... Clinical Process/Effectiveness. 

0143 ................... Title: Use of relievers for inpatient asthma ............................................

Description: Percentage of pediatric asthma inpatients, age 2–17, 

who were discharged with a principal diagnosis of asthma who received relievers for inpatient asthma.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

State use ....................... New ....... Clinical Process/Effectiveness. 

0144 ................... Title: Use of systemic corticosteroids for inpatient asthma ...................

Description: Percentage of pediatric asthma inpatients (age 2–17 

years) who were discharged with principal diagnosis of asthma who 

received systemic corticosteroids for inpatient asthma.

The Joint Commission (TJC) www.

jointcommission.org and click on 

‘‘Contact Us’’.

State use ....................... New ....... Clinical Process/Effectiveness. 

0484 ................... Title: Proportion of infants 22 to 29 weeks gestation treated with surfactant who are treated within 2 hours of birth.

Description: Number of infants 22 to 29 weeks gestation treated with 

surfactant within 2 hours of birth.

Vermont Oxford Network www.

vtoxford.org and click on ‘‘Contact Us’’.

State use ....................... New ....... Clinical Process/Effectiveness. 

0716 ................... Title: Healthy Term Newborn .................................................................

Description: Percent of term singleton livebirths (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: Hearing screening prior to hospital discharge (EHDI-1a) .............

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. 

1653 ................... Title: IMM-1 Pneumococcal Immunization (PPV23) ..............................

Description: This prevention measure addresses acute care hospitalized inpatients 65 years of age and older (IMM-1b) AND inpatients 

aged between 6 and 64 years (IMM-1c) who are considered high 

risk and were screened for receipt of 23-valent pneumococcal polysaccharide vaccine (PPV23) and were vaccinated prior to discharge if indicated. The numerator captures two activities; screening and the intervention of vaccine administration when indicated. 

As a result, patients who had documented contraindications to 

PPV23, patients who were offered and declined PPV23 and patients who received PPV23 anytime in the past are captured as numerator events.

Oklahoma Foundation for Medical 

Quality (OFMQ) www.ofmq.com 

and click on ‘‘Contact’’.

IQR ................................ New ....... Population/Public 

Health. 

1659 ................... Title: IMM-2 Influenza Immunization ......................................................

Description: This prevention measure addresses acute care hospitalized inpatients age 6 months and older who were screened for seasonal influenza immunization status and were vaccinated prior to 

discharge if indicated. The numerator captures two activities: 

Screening and the intervention of vaccine administration when indicated. As a result, patients who had documented contraindications 

to the vaccine, patients who were offered and declined the vaccine 

and patients who received the vaccine during the current year’s influenza season but prior to the current hospitalization are captured 

as numerator events.

Influenza (flu) is an acute, contagious, viral infection of the nose, 

throat and lungs (respiratory illness) caused by influenza viruses. 

Outbreaks of seasonal influenza occur annually during late autumn 

and winter months although the timing and severity of outbreaks 

can vary substantially from year to year and community to community. Influenza activity most often peaks in February, but can peak 

rarely as early as November and as late as April. In order to protect as many people as possible before influenza activity increases, 

most flu-vaccine is administered in September through November, 

but vaccine is recommended to be administered throughout the influenza season as well. Because the flu vaccine usually first becomes available in September, health systems can usually meet 

public and patient needs for vaccination in advance of widespread 

influenza circulation.

Oklahoma Foundation for Medical 

Quality (OFMQ) www.ofmq.com 

and click on ‘‘Contact’’.

IQR ................................ New ....... Population/Public 

Health. 

*** 

IQR = Inpatient Quality Reporting. 

TJC = The Joint Commission. 

HVBP = Hospital Value-Based Purchasing. 

OQR = Outpatient Quality Reporting. 

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13764 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 

8. Proposed Reporting Methods for 

Eligible Hospitals and Critical Access 

Hospitals 

(a) Reporting Methods in FY 2013 

In the CY 2012 Hospital Outpatient 

Prospective Payment System (OPPS) 

final rule with comment period (76 FR 

74122), we implemented a pilot 

program for Medicare eligible hospitals 

and CAHs for 2012 that is intended to 

test and demonstrate our capacity to 

accept electronic reporting of clinical 

quality measure information. The title of 

this pilot program is the 2012 Medicare 

EHR Incentive Program Electronic 

Reporting Pilot for Eligible Hospitals 

and CAHs. The EHR Incentive Program 

Registration and Attestation System is 

located at https://ehrincentives.cms.gov/ 

hitech/login.action. 

(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 clinical 

quality measures selected by the 

Secretary ‘‘in a form and manner 

specified by the Secretary’’ as part of 

demonstrating meaningful use of 

Certified EHR Technology. Medicare 

eligible hospitals and CAHs that are in 

their first year of Stage 1 of meaningful 

use may report the 24 clinical quality 

measures from Table 9 through 

attestation for a continuous 90-day EHR 

reporting period as described in section 

II.B.1. of this proposed rule. Readers 

should refer to the discussion in the 

Stage 1 final rule for more information 

about reporting clinical quality 

measures through attestation (75 FR 

44430 through 44431). Medicare eligible 

hospitals and CAHs would select one of 

the following two options for submitting 

clinical quality measures electronically. 

• Option 1: Submit the selected 24 

clinical quality measures through a 

CMS-designated portal. 

For this option, the clinical quality 

measures 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 the 

eligible hospitals and CAHs to log into 

a CMS-designated portal. Once the 

eligible hospitals and CAHs have logged 

into the portal, they would be required 

to submit through an upload process, 

data that is based on specified structures 

produced as output from their Certified 

EHR Technology. 

• Option 2: Submit the selected 24 

clinical quality measures in a manner 

similar to the 2012 Medicare EHR 

Incentive Program Electronic Reporting 

Pilot for Eligible Hospitals and CAHs 

using Certified EHR Technology. 

We propose that, as an alternative to 

the aggregate-level reporting schema 

described previously under Option 1, 

Medicare eligible hospitals and CAHs 

that successfully report measures in an 

electronic reporting method similar to 

the 2012 Medicare EHR Incentive 

Program Electronic Reporting Pilot for 

Eligible Hospitals and CAHs using 

Certified EHR Technology would satisfy 

their clinical quality measures 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 are considering an ‘‘interim 

submission’’ option for Medicare 

eligible hospitals and CAHs that are in 

their first year of Stage 1 beginning in 

FY 2014 and available in subsequent 

years 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 submit 

clinical quality measures data for a 

continuous 90-day EHR reporting 

period, and the data must be received 

no later than July 1 to meet the 

requirements of the EHR Incentive 

Program. We request public comment 

on this potential option. 

We are considering 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 request 

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 intend 

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. 

We note that the Hospital IQR 

program does not currently have an 

electronic reporting mechanism. We 

invite comment on whether an 

electronic reporting option would be 

appropriate for the Hospital IQR 

Program and whether it would provide 

further alignment with the EHR 

Incentive Program. 

(c) Electronic Reporting of Clinical 

Quality Measures for Medicaid Eligible 

Hospitals 

States that have launched their 

Medicaid EHR Incentive Programs plan 

to collect clinical quality measures 

electronically from Certified EHR 

Technology 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 Stage 

1 clinical quality measures 

electronically will be similar for Stage 2. 

However, we note that subject to our 

prior approval, the process, 

requirements, and the timeline is within 

the States’ purview. 

C. Demonstration of Meaningful Use 

and Other Issues 

1. Demonstration of Meaningful Use 

a. Common Methods of Demonstration 

in Medicare and Medicaid 

We propose 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 would automatically be 

available to the States for use in their 

Medicaid programs. The Medicare 

methods are segmented into clinical 

quality measures and meaningful use 

objectives. 

b. Methods for Demonstration of the 

Stage 2 Criteria of Meaningful Use 

We do not propose changes to the 

attestation process for Stage 2 

meaningful use objectives, except the 

group reporting option discussed in 

section II.C.1.c. of this proposed rule. 

Several changes are proposed for 

clinical quality measure reporting, as 

discussed in section II.B.3. of this 

proposed 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 would revise § 495.8 to 

accommodate the Stage 2 objective and 

measures, as well as changes we are 

making to Stage 1. 

As HIT matures we expect to base 

demonstration more on automated 

reporting by certified EHR technologies, 

such as the direct electronic reporting of 

measures both clinical and nonclinical 

and documented participation in HIE. 

As HIT advances we expect to move 

more of the objectives away from being 

demonstrated through attestation. 

However, at this time we do not believe 

that the advances in HIT and the 

certification of EHR technologies allow 

us to propose an alternative to 

attestation in this proposed rule. We 

continue to evaluate the possible 

alternatives to attestation and the 

changes to certification and/or 

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Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 13765 

meaningful use. As discussed later, 

while we would continue to require 

analysis of all meaningful use measures 

at the individual EP, eligible hospital or 

CAH level, we are proposing a batch file 

process in lieu of individual Medicare 

EP attestation through the CMS 

Attestation Web site beginning with CY 

2014. This batch reporting process will 

ensure that meaningful use of certified 

EHR technology continues to be 

measured at the individual level, while 

promoting efficiencies for group 

practices that must submit attestations 

on large groups of individuals. 

We would continue to leave open the 

possibility for CMS and/or the States to 

test options to utilize existing and 

emerging HIT products and 

infrastructure capabilities to satisfy 

other objectives of the meaningful use 

definition. The optional testing could 

involve the use of registries or the direct 

electronic reporting of some measures 

associated with the objectives of the 

meaningful use definition. We would 

not require any EP, eligible hospital or 

CAH to participate in this testing in 

either 2013 or 2014 in order to receive 

an incentive payment or avoid the 

payment adjustment. 

c. Group Reporting Option of 

Meaningful Use Core and Menu 

Objectives and Associated Measures for 

Medicare and Medicaid EPs Beginning 

With CY 2014 

For Stage 1, EPs were required to 

attest and report on core and menu 

objectives on an individual basis and 

did not have an option to report 

collectively with other EPs in the same 

group practice. Under section 

1848(o)(2)(A) of the Act, the Secretary 

may provide for the use of alternative 

means for eligible professionals 

furnishing covered professional services 

in a group practice (as defined by the 

Secretary) to meet the requirements of 

meaningful use. For EHR reporting 

periods occurring in CY 2014 and 

subsequent years, we are proposing a 

group reporting option to allow 

Medicare EPs within a single group 

practice to report core and menu 

objective data through a batch file 

process in lieu of individual Medicare 

EP attestation through the CMS 

Attestation Web site. The purpose of 

proposing a group reporting option is to 

provide administrative relief to group 

practices that have large numbers of EPs 

who need to attest to meaningful use. 

This option is intended to allow a batch 

reporting of each individual EP’s core 

and menu objective data, and each EP 

would still have to meet the required 

meaningful use thresholds 

independently. This option does not 

permit any EP to meet the required 

meaningful use thresholds through the 

use of a group average or any other 

method of group demonstration. 

We would establish a file format in 

which groups would be required to 

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 upload. 

States would have the option of 

offering batch reporting of meaningful 

use data for Medicaid EPs. States would 

need to outline their approach in their 

State Medicaid HIT Plan. 

For purposes of this group reporting 

option, we propose to 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). This is the same 

definition as one proposed in the group 

reporting option of clinical quality 

measures. States choosing to exercise 

this option would 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 would 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 would 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. 

This group reporting option would be 

limited to data for the core and menu 

objectives, but it would not include the 

reporting of clinical quality measures, 

which is also required in order to 

demonstrate meaningful use and receive 

an EHR incentive payment. Clinical 

quality measures must be reported 

separately through one of the electronic 

submission options that are described in 

section II.B. of this proposed rule. 

Because we are proposing multiple 

group reporting methods for clinical 

quality measures, EPs would not have to 

report core and menu objective data in 

the same EHR Incentive Group as they 

report their clinical quality measures. 

An EP would be able to submit the core 

and menu objectives as part of a group 

and the clinical quality measures as an 

individual or vice versa (that is, use 

clinical quality group reporting, while 

using individual reporting for the core/ 

menu objectives).Please note that EPs 

would not be required to batch report as 

part of a group, and would still be 

permitted to attest individually through 

the CMS Attestation Web site (as long as 

they did not also report as part of a 

group). In order to demonstrate 

meaningful use and avoid any payment 

adjustments applicable under the 

Medicare EHR Incentive Program, EPs 

would be required to individually meet 

all of the thresholds of the core and 

menu objectives. In other words, an EP 

cannot avoid payment adjustments 

through the use of a group average or 

any other method of group 

demonstration. Payment adjustments 

would be applied to individual EPs, as 

described in section II.C. of this 

proposed rule and not to Medicare EHR 

Incentive Groups. 

An EP’s incentive payment would not 

be automatically assigned to the 

Medicare EHR Incentive Group with 

which they batch report under this 

option. The EP would still have to select 

the payee TIN during the registration 

process. 

EPs that practice in multiple practices 

or locations would be responsible for 

submitting complete information for all 

actions taken at practices/locations 

equipped with Certified EHR 

Technology. Under 42 CFR 495.4, to be 

considered a meaningful EHR user, an 

EP must have 50 percent or more of 

their patient encounters in practice(s) or 

location(s) where Certified EHR 

Technology is available. In the July 28, 

2010 final rule (75 FR 44329), we also 

made clear that an EP must include 

encounters for all locations equipped 

with Certified EHR Technology. We are 

not proposing to change these 

requirements in this rulemaking. 

Therefore, an EP who chooses the group 

reporting option would be required to 

include in such reporting core and 

menu objective information on all 

encounters where Certified EHR 

Technology is available, even if some 

encounters occurred at locations not 

associated with the EP’s Medicare EHR 

Incentive Group. We are not proposing 

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 Certified EHR 

Technology could report all of their core 

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13766 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 

and menu objective data as part of an 

EHR Incentive Group in which they had 

only 5 percent of their patient 

encounters, provided they report all of 

the data from the other locations 

through the batch reporting process. 

We also seek public comment on a 

group reporting option that allows 

groups an additional reporting option in 

which groups report for their EPs a 

whole rather than broken out by 

individual EP. 

In the January 18, 2011 Federal 

Register (76 FR 2910), the Health IT 

Policy Committee published a request 

for comment, to which 422 

organizations and individuals submitted 

comments. In it, the committee invited 

comment on the following question, 

‘‘Should Stage 2 allow for a group 

reporting option to allow group 

practices to demonstrate meaningful use 

at the group level for all EPs in that 

group?’’ 

The majority of those responding to 

this question supported this approach as 

one reporting option for EPs. 

Commenters often cited that a group 

reporting option will reduce 

administrative burden. Many 

commenters expressed an opinion that 

permitting group reporting may harness 

EP competition that will improve 

performance with peers within the 

group practice. Furthermore, 

commenters also stated that this option 

would: Facilitate physician teamwork 

and care coordination, be helpful for 

specialists and community health 

centers, and highlight system-level 

performance, thus creating incentives to 

invest in system-wide improvement 

programs. 

When commenting on the group 

reporting option we are providing the 

following list of suggested topics, but 

this list is by no means exhaustive: 

• What should the definition of a 

group be for the exercise of group 

reporting? For example, under the PQRS 

Group Reporting Option, a group is 

defined as a physician group practice, as 

defined by a single Tax Payer 

Identification Number, with 25 or more 

individual eligible professionals who 

have reassigned their billing rights to 

the TIN. We could adopt this definition 

or an alternative definition. 

• Should there be a self nomination 

process for groups as in PQRS or an 

alternative process for identifying 

groups? 

• Regarding the availability of 

Certified EHR Technology across the 

group, should the group be required to 

utilize the same Certified EHR 

Technology? 

• Should a group be eligible if 

Certified EHR Technology (same or 

different) is not available to all 

associated EPs at all locations? 

• Should a group be eligible if they 

use multiple Certified EHR 

Technologies that cannot share data 

easily? 

• With respect to EPs who practice in 

multiple groups or in a group and 

practice individually, how should 

meaningful use activities be calculated? 

• As the HITECH Act requires all 

meaningful users to be paid 75 percent 

of all covered services, how should the 

covered services performed by EPs in 

another practice be assigned to the 

group TIN? 

• How will meaningful use activities 

performed at other groups be included? 

• Should these services be included 

in the attesting group, or should CMS 

just ignore this information or account 

for it in other ways? 

• How should the government 

address an EPs failure to meet a measure 

individually? 

• If an EP chooses not to participate 

in a particular objective should they be 

a meaningful EHR user under the group 

if their non-participation still allows 

group compliance with a percentage 

threshold? 

• How should yes/no objectives be 

handled in this situation? 

• Some EPs in a group participate in 

Medicaid while others participate in 

Medicare; what covered services should 

the meaningful use calculation capture? 

• Incentive payment assignment. 

• Should the incentive payment be 

reassigned to the group automatically or 

does the EP still need to assign it to the 

group at registration? 

• Should the same policy exist if the 

EP has covered services billed to other 

TINs? 

• How should covered services for 

EPs who leave a group during an active 

EHR reporting period be handled? 

• How should payment adjustments 

for Group reporting be handled? 

• What alternative options should be 

considered for reporting meaningful 

use, while capturing necessary data? 

For options presented, please share 

how each would be effectively 

implemented while meeting the 

objectives of the statute. For example, 

should EPs continue to report 

individually, use the batch file process 

proposed in this proposed rule or be 

included in a report of all EP data 

combined under one TIN? 

2. Data Collection for Online Posting, 

Program Coordination, and Accurate 

Payments 

In addition to the data already being 

collected under our regulations 

(§ 495.10), we propose to collect the 

business email address of EPs, eligible 

hospitals and CAHs to facilitate 

communication with providers. We do 

not propose to post this information 

online. We propose to amend § 495.10 

accordingly. We propose to begin 

collection 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 do 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. 

3. Hospital-Based Eligible Professionals 

We propose changes to the definition 

of a hospital-based eligible professional 

only to recognize the determination of 

hospital-based once Medicare providers 

are subject to payment adjustments. We 

refer readers to section II.D.2. of this 

proposed rule for that discussion. 

While we are not proposing changes 

to the definition, we do seek comments 

on the following discussion. The 

definition of ‘‘hospital-based’’ in the 

Social Security Act discusses the 

eligible professional 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). In the Stage 1 final rule, we 

addressed comments on this portion of 

the definition (75 FR 44441). 

Nevertheless, during implementation of 

Stage 1, we have been 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 in-patient) definition of meaningful 

use. These inquiries point out that such 

situations are uncommon and might not 

be generalized under the uniform 

definition used by place of service 

codes. 

We solicit comments on this issue. 

Specifically, comments should address 

and provide documentation supporting 

whether specialized hospital units are 

using stand-alone certified EHR 

technology separate from that of the 

hospital. In addition, the comments 

should address (and we would request 

documentation on) whether EPs are 

using the facilities and equipment of the 

hospital. We consider hospital facilities 

and equipment to refer to the physical 

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environment needed to support the 

necessary hardware; internet access 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. 

Thus, comments should address 

whether EPs using stand-alone certified 

EHR technology separate from that of 

the hospital, are truly not accessing the 

facilities and equipment of the 

hospitals. We would appreciate 

discussions of EP workflow to 

demonstrate how the EPs avoid use of 

such facilities and equipment. 

Were we to adopt a policy on this 

issue, we believe additional attestation 

elements would need to be added to the 

determination of whether an EP is 

hospital-based. Such attestations would 

be subject to audit and the False Claims 

Act. In addition, were we to adopt a 

policy on this issue, EPs found not to be 

hospital-based would not only be 

potentially eligible for incentive 

payments, but also subject to payment 

adjustments under Medicare. 

We also request 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 would 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. 

We reiterate this policy in section 

II.A.3.d.(2). of this proposed rule, where 

we explain that all meaningful use 

policies for EPs apply only to outpatient 

settings (all settings except the inpatient 

and emergency department of a 

hospital). Some of our meaningful use 

criteria for EPs are measured based on 

office visits (clinical summaries) and 

others assume an outpatient type of 

setting (patient reminders). The 

certification rules at 45 CFR part 170 

differentiate between ambulatory and 

inpatient EHRs, and it is unclear 

whether the EPs in this case would have 

inpatient or ambulatory technology. We 

request comments on this issue. Finally, 

we request comments as to whether 

patients affected by this situation would 

essentially be ‘‘double-counted;’’ once 

for the hospital’s EHR incentive 

payment, and once for the EP’s 

incentive payment, and whether and 

how this issue should be addressed, 

such as potentially excluding discharges 

associated with EPs who receive an 

incentive payment based upon the same 

inpatient. 

4. Interaction With Other Programs 

There are no proposed changes to the 

ability of providers to participate in the 

Medicare and Medicaid EHR incentive 

programs and other CMS programs. 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 proposed rule for the 

proposed alignment initiatives for 

clinical quality measures. 

D. Medicare Fee-for-Service 

1. General Background and Statutory 

Basis 

As we discussed in the Stage 1 final 

rule (75 FR 44447), sections 4101(a) and 

4102(a) of the HITECH Act amended 

sections 1848, 1886, and 1814(l) of the 

Act to provide for incentive payments to 

EPs, hospitals, and CAHs that are 

meaningful users of certified EHR 

technology. Depending upon when the 

EP, hospital, or CAH first qualifies as a 

meaningful user of EHR technology, 

these incentive payments could begin as 

early as CY 2011 for EPs, FY 2011 for 

hospitals, or a cost reporting period 

beginning during FY 2011 for CAHs. In 

no case may these incentive payments 

be made later than CY 2016 for EPs, FY 

2016 for hospitals or a cost reporting 

period beginning after the end of FY 

2015 for CAHs. 

As we also discussed in the Stage 1 

final rule, sections 4101(b) and 4102(b) 

of the HITECH Act provide as well for 

reductions in payments to EPs, 

hospitals, and CAHs that are not 

meaningful users of certified EHR 

technology, 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 proposals for 

implementing these mandatory payment 

reductions. 

2. Payment Adjustment Effective in CY 

2015 and Subsequent Years for EPs Who 

Are Not Meaningful Users of Certified 

EHR Technology 

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 who are not 

meaningful EHR users during the 

relevant EHR reporting period for the 

year. (As defined in § 495.100 of the 

regulations, for these purposes an EP is 

a physician, which includes a doctor of 

medicine or osteopathy, a doctor of 

dental surgery or medicine, a doctor of 

podiatric medicine, a doctor of 

optometry, or a chiropractor.) 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 would 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: ‘‘(1) for 

2015, 99 percent (or, in the case of an 

EP who was subject to the application 

of the payment adjustment if the EP is 

not a successful electronic prescriber in 

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.’’ 

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 

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. 

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a. Applicable Payment Adjustments for 

EPs Who Are Not Meaningful Users of 

Certified EHR Technology in CY 2015 

and Subsequent Calendar Years 

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 would 

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 are proposing 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. 

We expect to base the determination 

each year on the most recent CY for 

which we have sufficient data. The 

computation would be based on the 

ratio of EPs who have qualified as 

meaningful users in the numerator, to 

Medicare-enrolled EPs in the 

denominator. We note that the statute 

requires us to base this determination 

on ‘‘the proportion of eligible 

professionals who are meaningful EHR 

users (as determined under subsection 

(o)(2).’’ Both hospital-based EPs and EPs 

who have been granted any of the 

exceptions that we are proposing remain 

EPs within the statutory definition of 

the term, as implemented in our 

regulations in § 495.100 of our 

regulations. However, hospital-based 

EPs and EPs granted a exception would 

not be subject to the determination of 

meaningful use status ‘‘under 

subsection (o)(2).’’ Therefore, we are 

proposing to exclude from the 

denominator of the requisite ratio both 

the total number of EPs granted an 

exception in the most recent CY for 

which we have sufficient data, and all 

hospital-based EPs from the relevant 

period. We anticipate that we would 

compute the requisite ratio of EPs who 

are meaningful EHR users based on 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 

would provide more specific detail on 

this computation in future guidance 

after the final regulation is published. 

We note that, in general terms, these 

two 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 would 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 also subject to the application of the 

payment adjustment for e-prescribing 

under section 1848(a)(5) of the Act 

would be 98 percent of the Medicare 

PFS amount. In CY 2016, the adjustment 

to the Medicare PFS amount that would 

otherwise apply will be 98 percent. 

Similarly, the adjustment to the 

Medicare PFS amount that would 

otherwise apply would 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. 

It is important to note 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 

certified EHR technology, as provided in 

§ 495.8(a)(2)(iv). However, AIU does not 

constitute meaningful use of certified 

EHR technology. Therefore, those EPs 

who receive an incentive payment for 

AIU would 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 

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 participation). 

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. 

TABLE 10—PERCENT ADJUSTMENT FOR CY 2015 AND SUBSEQUENT YEARS, ASSUMING THAT THE SECRETARY FINDS

THAT LESS THAN 75 PERCENT OF EPS ARE MEANINGFUL EHR USERS FOR CY 2018 AND SUBSEQUENT YEARS

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 11—PERCENT ADJUSTMENT FOR CY 2015 AND SUBSEQUENT YEARS, ASSUMING THAT THE SECRETARY ALWAYS

FINDS THAT AT LEAST 75 PERCENT OF EPS ARE MEANINGFUL EHR USERS FOR CY 2018 AND SUBSEQUENT YEARS

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 

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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 would 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 the case of EPs, we have 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. 

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 discuss in the separate sections later 

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 do 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 are proposing that EHR 

reporting periods for payment 

adjustments would begin and end prior 

to the year of the payment adjustment. 

Furthermore, we are proposing 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 believe that the 

following rules should 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 second 

bulleted paragraph, we propose 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 2013. This proposal 

would align reporting periods for 

multiple physician reporting programs. 

For EPs this would generally be a full 

calendar year (unless 2013 is the first 

year of demonstrating meaningful use, 

in which case a 90-day EHR reporting 

period would apply). Under this 

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 for 2013 

would be subject to a payment 

adjustment in 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 CY 2015, the EHR 

reporting period for the payment 

adjustment would continue to be the 

calendar year 2 years prior to the 

payment adjustment period, subject 

again to the special exception for new 

meaningful users of the Certified EHR 

Technology as follows: 

We would create an exception for 

those EPs who have never successfully 

attested to meaningful use in the past 

nor during the regular EHR reporting 

period we are proposing in the first 

bulleted paragraph. For these EPs, as it 

is their first year of demonstrating 

meaningful use, for the 2015 payment 

adjustment, we propose 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 actually 

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, this means 

specifically that 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, is October 1, 2014. Thus, the EP’s 

EHR reporting period must 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). 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. 

We believe that these proposed EHR 

reporting periods provide adequate time 

both for the systems changes that will be 

required for us to apply any applicable 

payment adjustments in CY 2015 and 

subsequent years, and for EPs 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 

reasonable opportunity to establish their 

meaningful use of the technology and to 

avoid application of the payment 

adjustments. We welcome comments on 

this proposal. 

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 would 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, we believe that given the 

timeframes of the HITECH Act payment 

adjustments there are hardships for 

which an exception should be granted. 

We propose three types of exceptions in 

this proposed rule and are considering 

a potential fourth. We request public 

comments on all four exception options. 

Three types are by definition time 

limited and should not be at risk of 

existing for more than 5 years. The 

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potential fourth refers to barriers facing 

EPs as discussed further. We believe 

that these barriers will be lowered over 

time as internet access, health 

information exchange and Certified EHR 

Technology itself becomes available 

more widely. However, we note that the 

5 year limitation is statutory and cannot 

be altered by regulations. 

In the Stage 1 final rule, we provided 

for this exception in our regulations at 

§ 495.102(d)(3). However, we did not 

specify the specific circumstances, 

process, or period for which an 

exception would be granted. We 

therefore propose to modify the 

provision (in a renumbered 

§ 495.102(d)(4)) to specify the 

circumstances under which an 

exception would be granted. 

First, we propose that the Secretary 

may grant an exception to EPs who 

practice in areas without sufficient 

Internet access. This is in keeping with 

the language at section 1848(a)(7)(B) of 

the Act that a significant hardship may 

exist ‘‘in the case of an eligible 

professional who practices in a rural 

area without sufficient Internet access.’’ 

It also recognizes that a non-rural 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. 

Because exceptions on the basis of 

insufficient Internet connectivity must 

intrinsically be considered on a case-bycase basis, we believe that it is 

appropriate to require EPs to 

demonstrate insufficient Internet 

connectivity to qualify for the exception 

through an application process. As we 

have noted, 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, summary of care 

documents, electronic prescribing, 

making health information available 

online and submission of public health 

information. Therefore, we believe that 

the application must demonstrate 

insufficient Internet connectivity to 

comply with the meaningful use 

objectives listed previously and 

insurmountable barriers to obtaining 

such infrastructure, such as a high cost 

of extending the Internet infrastructure 

to their facility. The hardship would be 

shown for the year that is 2 years prior 

to the payment adjustment year. We 

would 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. 

We are proposing to establish the 

hardship period 2 years prior to the 

payment adjustment year because, by 

definition, the majority of EPs without 

sufficient Internet connectivity would 

not have previously been meaningful 

EHR users. EPs who have never 

demonstrated meaningful use would 

generally have a short (90-day) EHR 

reporting period that occurs in the year 

before the payment adjustment year. 

However, if there is insufficient Internet 

connectivity in the year prior to that 

reporting period, we believe it is 

reasonable to assume that the EP would 

face hardships during the reporting 

period year, if the EP acquired Internet 

connectivity and then were required to 

obtain Certified EHR Technology, 

implement it, and become a meaningful 

EHR user all in the same year. 

We also encourage EPs to apply for 

the exception as soon as possible, which 

would be 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. 

Secondly, we propose to provide an 

exception for new EPs for a limited 

period of time after the EP has begun 

practicing. Newly practicing EPs would 

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 are 

proposing that for 2 years after they 

begin practicing, EPs could receive an 

exception from the payment 

adjustments that would otherwise apply 

in CY 2015 and thereafter. We note that, 

for purposes of this exception, an EP 

who switches specialties and begins 

practicing under a new specialty would 

not be considered newly practicing. For 

example, an EP who begins practicing in 

CY 2015 would receive an exception 

from the payment adjustments in CYs 

2015 and 2016. However, as discussed 

previously, the new EP would 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 would 

be subject to the payment adjustment in 

CY 2017. We will 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. 

Thirdly, we are proposing an 

additional exception in this proposed 

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 

believe that it is appropriate to require 

EPs to qualify for the exception through 

an application process. 

We would 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 for EPs who would 

have otherwise be able to become 

meaningful EHR users and avoid the 

payment adjustment for a given year. 

Therefore, it is not necessary to account 

for circumstances that arise during a 

payment adjustment year, but rather 

those that arise in the two years prior to 

the payment adjustment year (that is in 

the calendar year immediately prior to 

the payment adjustment year, or the 

calendar year that is 2 years prior). 

Finally, we are soliciting comments 

on the appropriateness of granting an 

exception for EPs meeting certain 

criteria. These include— 

• 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 is able to 

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. 

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Certain physicians often do not have a 

consultative interaction with the 

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 transporting information online are 

significantly easier to meet if a provider 

immediate contact with or follows up 

with or contact patients; and 

• Lack of control over the availability 

of Certified EHR Technology at their 

practice locations. 

We do not believe that any one of 

these barriers taken independently 

constitutes 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. 

One option is to provide a time-limited, 

two 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 is to 

provide such an exception with no 

specific time limit. However, we note 

that even under this less restrictive 

option, by statute no individual EP can 

receive an exception for more than five 

years. As discussed earlier, we believe 

the proliferation of both Certified EHR 

Technology 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 request comment on how 

soon EPs who meet the previous criteria 

would reasonably be able to achieve 

meaningful use. 

We believe that EPs who meet the 

criteria listed previously face unique 

challenges in trying to successfully 

achieve meaningful use. However, we 

encourage comment on whether these 

criteria, or additional criteria not 

accounted for in the meaningful use 

exclusions constitute a significant 

hardship to meeting meaningful use. For 

the final rule, we will consider whether 

to adopt an exception based on these or 

similar criteria, and, if so, whether such 

an an exception should apply to 

individual EPs or across-the-board 

based on specialty or other groupings 

that generally meet the appropriate 

criteria. 

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 

penalty: 

TABLE 12—TIMELINE FOR ELIGIBLE PROFESSIONALS (OTHER THAN HOSPITAL-BASED) TO AVOID PAYMENT ADJUSTMENT

EP Payment 

adjustment year 

(calendar year) 

Establish meaningful use for the full 

calendar year 2 years prior: OR 

For an EP demonstrating meaningful 

use for the first time in the year prior 

to the payment adjustment year in a 

continuous 90-day reporting period 

beginning no later than: 

OR Apply for an exception 

no later than: 

2015 ............................... CY 2013 (with submission period the 

2 months following the end of the 

reporting period).

July 3, 2014 (with submission no 

later than October 1, 2014).

July 1, 2014. 

2016 ............................... CY 2014 (with submission period the 

2 months following the end of the 

reporting period).

July 3, 2015 (with submission no 

later than October 1, 2015).

July 1, 2015. 

2017 ............................... CY 2015 (with submission period the 

2 months following the end of the 

reporting period).

July 3, 2016 (with submission no 

later than October 1, 2016).

July 1, 2016. 

2018 ............................... CY 2016 (with submission period the 

2 months following the end of the 

reporting period).

July 3, 2017 (with submission no 

later than October 1, 2017).

July 1, 2017. 

2019 ............................... CY 2017(with submission period the 

2 months following the end of the 

reporting period).

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. 

d. 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 believe 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 would also be subject to 

adjustments). Therefore, 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. Section 495.4 

defines a hospital-based EP as ‘‘an EP 

who furnishes 90 percent or more of his 

or her covered professional services in 

a hospital setting in the year preceding 

the payment year. A setting is 

considered a hospital setting if it is a 

site of service that would be identified 

by the codes used in the HIPAA 

standard transactions as an inpatient 

hospital, or emergency room setting.’’ 

We further specified in the definition of 

hospital-based eligible professional that, 

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 that 

final rule (75 FR 44442), we also stated 

that ‘‘in order to provide information 

regarding the hospital-based 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 would 

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 

will retain the concept established in 

the stage 1 final rule (75 FR 44442) of 

making hospital-based determinations 

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based upon a prior fiscal year of data. 

However, we are concerned 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. While 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 would 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 would allow an EP to 

know whether he or she is hospitalbased 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 do not 

believe this is sufficient time for the EP 

to implement Certified EHR 

Technology. Therefore, we are 

proposing 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 Certified EHR Technology 

and begin the EHR reporting period to 

avoid the CY 2015 payment adjustment. 

We consider 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 non-hospital-based 

under this ‘‘2 years prior’’ policy when 

they would be determined hospitalbased if we made the determination just 

1 year prior. Again, using the example 

of the CY 2015 payment adjustment 

year, an EP determined non-hospitalbased as of January 1, 2013 (using FY 

2012 data) may be found to be hospitalbased as of January 1, 2014 (using FY 

2013 data). In this situation, we do not 

believe the EP should be penalized for 

having been non-hospital based as of 

January 1, 2013, especially if the EP has 

never demonstrated meaningful use, 

and the EP’s first EHR reporting period 

would have fallen within CY 2014. 

Therefore, for the final rule, we are 

considering 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. 

3. Incentive Market Basket Adjustment 

Effective in FY 2015 and Subsequent 

Years for Eligible Hospitals That Are 

Not Meaningful EHR Users 

In addition to providing for incentive 

payments for meaningful use of EHRs, 

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 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 (662⁄3 percent of 75 percent) 

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.’’ 

TABLE 13—PERCENTAGE DECREASE IN

APPLICABLE HOSPITAL PERCENTAGE

INCREASE FOR HOSPITALS THAT ARE

NOT MEANINGFUL EHR USERS

2015 2016 2017+ 

Hospital is subject to EHR 

payment adjustment ......... 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 would 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 would 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 

will also 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.). It is 

important to note the results of this 

policy for certain cases in which 

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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 would not 

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 we thus continues to 

assign the same CCN, we would 

continue to recognize the demonstration 

of meaningful use under that CCN. The 

same policy would apply to 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 

would 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 

2779A ff.) We advise hospitals that are 

changing ownership, merging, or 

otherwise reorganizing to take this 

policy into account. 

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 of this 

chapter, three-fourths of the applicable 

percentage change specified in paragraph 

(d)(1) of this section is reduced— 

(i) For fiscal year 2015, by 331⁄3 percent; 

(ii) For fiscal year 2016, by 662⁄3 percent; 

and 

(iii) 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 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. 

In this proposed rule, we have no 

further proposals specifically regarding 

the establishment of the applicable 

percentage increase adjustment for 

eligible hospitals who are not 

meaningful EHR users for FY 2015 and 

subsequent FYs beyond the provisions 

we have just cited. However, we believe 

that the existing regulatory provisions 

establishing the applicable percentage 

increase adjustment need to be 

supplemented to ensure that it is clear 

that 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, will be a prior EHR reporting 

period (as defined in § 495.4 of the 

regulations). We have also proposed an 

amendment to § 412.64(d) to recognize 

the availability of the exception, 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 issues and 

present our proposals 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’’ the EHR 

reporting period that will apply ‘‘with 

respect to a [calendar or 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 wish 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 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. 

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 affect 

the settlement of final payment amounts 

under the cost report reconciliation 

process. Since the EHR payment 

adjustment in FYs 2015 and subsequent 

years is an adjustment to the applicable 

percentage increase, 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 are proposing, 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 will establish EHR reporting periods 

that begin and end prior to the year of 

the payment adjustment. Furthermore, 

we are proposing that the EHR reporting 

periods for purposes of such 

determinations will be far enough in 

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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 believe that 

the following rules should apply for 

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, we propose that the 

EHR reporting period for the FY 2015 

applicable percentage increase 

adjustment would be the same EHR 

reporting period that applies in order to 

receive the incentive for FY 2013. For 

hospitals this would generally be the 

full fiscal year (unless FY 2013 is the 

first year of demonstrating meaningful 

use, in which case a 90-day EHR 

reporting period would apply). Under 

this 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 would 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 

would continue to be the FY 2 years 

before the payment period, subject again 

to the special provision for new 

meaningful users of certified EHR 

technology. 

• We would create an exception for 

those hospitals that have never 

successfully attested to meaningful use 

in the past nor during the regular EHR 

reporting period we are proposing in the 

first bulleted paragraph previously. For 

these hospitals, as it is their first year of 

demonstrating meaningful use, we 

propose 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 3, 

2014 (allowing the hospital a 90-day 

EHR reporting period, followed by one 

extra day to successfully submit the 

attestation and any other information 

necessary to earn an incentive 

payment). 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 would 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 would need to be completed by 

July 1. (As we discuss later, exception 

requests would be due by the April 1 

before the beginning of the next fiscal 

year.) 

In conjunction with adopting these 

rules for determining the EHR Reporting 

Period for determining whether a 

hospital is subject to the applicable 

percentage increase adjustment for FY 

2015 and subsequent FYs, we are 

specifically proposing 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 believe 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 reasonable opportunity to 

establish their meaningful use of the 

technology and to avoid application of 

the payment adjustments. We welcome 

comments on this proposal. 

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 

would 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. 

In this proposed rule we are 

proposing to add a new§ 412.64(d)(4), 

specifying the circumstances under 

which we would 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 or both of the following criteria. 

As noted previously, the statute does 

not mandate the circumstances under 

which an exception must be granted, 

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 would result in a 

significant hardship, such as in the case 

of a hospital in a rural area without 

sufficient Internet access.’’ We are 

therefore proposing 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 non-rural area may 

also lack sufficient Internet access to 

make complying with meaningful use 

requirements a significant hardship for 

a hospital. Therefore, we are providing 

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 believe that it is 

appropriate to require hospitals to 

demonstrate insufficient Internet 

connectivity to qualify for the exception 

through an application process. The 

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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 believe 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 would 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 

would 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.) 

For the same reasons we are 

proposing an exception for new EPs, we 

propose an exception for a new hospital 

for a limited period of time after it has 

begun services. We would 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, it is important 

to ensure that the exception is not 

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, the following hospitals 

would not be considered new hospitals 

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 would 

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 

this 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 would 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 would 

allow the CAH to register its meaningful 

use designation obtained under its 

previous CCN in order to avoid being 

subject the hospital payment 

adjustment. It is worth noting that we 

have 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 welcome comment 

concerning the appropriateness of 

adapting these rules to the exception 

under the EHR program, and about 

whether modifications or other 

revisions to these rules would be 

appropriate in the EHR context. 

Finally, we are proposing an 

additional exception in this proposed 

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. 

We would 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. The purpose 

of this exception is for hospitals who 

would have otherwise be able to become 

meaningful EHR users and avoid the 

payment adjustment for a given year. 

Therefore, it is not necessary to account 

for circumstances that arise during a 

payment adjustment year, but rather 

those that arise in the 2 years prior to 

the payment adjustment year. 

The following table 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. 

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TABLE 14—TIMELINE FOR ELIGIBLE HOSPITALS TO AVOID PAYMENT ADJUSTMENT

Hospital payment 

adjustment year 

(fiscal year) 

Establish meaningful use the full 

fiscal year 2 years prior: 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 period the 

2 months following the end of the 

reporting period).

April 3, 2014 (with submission no 

later than July 1, 2014).

April 1, 2014. 

2016 ............................... FY 2014 (with submission period the 

2 months following the end of the 

reporting period).

April 3, 2015 (with submission no 

later than July 1, 2015).

April 1, 2015. 

2017 ............................... FY 2015 (with submission period the 

2 months following the end of the 

reporting period).

April 3, 2016 (with submission no 

later than July 1, 2016).

April 1, 2016. 

2018 ............................... FY 2016 (with submission period the 

2 months following the end of the 

reporting period).

April 3, 2017 (with submission no 

later than July 1, 2017).

April 1, 2017. 

2019 ............................... FY 2017 (with submission period the 

2 months following the end of the 

reporting period).

April 3, 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. 

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. Such adjustments 

shall 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. In this 

context, we would consider 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 

propose a new § 412.64(d)(5) that 

includes this statutory requirement. 

States operating under a payment 

waiver under section 1814(b)(3) of the 

Act must 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. 

In this context, we are also proposing 

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). 

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 

would 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 

certified EHR technology for an 

applicable reporting period, then for a 

cost reporting period that begins in FY 

2015, its reimbursement would be 

reduced from 101 percent of its 

reasonable costs to 100.66 percent. For 

a cost reporting period beginning in FY 

2016, its reimbursement would 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 

would 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 propose 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 for its cost reporting period that 

begins in FY 2015. This differs from 

what is being proposed for eligible 

hospitals where the EHR reporting 

period will be prior to the market basket 

adjustment year. We believe 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 

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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 have proposed an amended 

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 would 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). 

CAHs are required 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 thereof) would 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. 

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 are proposing to 

revise these regulations to align them 

with the exceptions being proposed for 

EPs and subsection (d) hospitals. As 

with EPs and subsection (d) hospitals 

CAHs could apply for an exception on 

the basis of lack of sufficient Internet 

connectivity. Applications would 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, the insufficient Internet 

connectivity would need to be 

demonstrated for each applicable 

payment adjustment year. For example, 

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. 

As with new EPs and new eligible 

hospitals, we are also proposing an 

exception for a new CAH for a limited 

period of time after it has begun 

services. We would 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 one year 

after the CAH accepts its first patient. If 

the CAH is established March 15 of 

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 of 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). 

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, 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. 

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 penalty provision in FY 2015 

and subsequent years if they fail to 

demonstrate meaningful use of EHR 

technology during an applicable 

reporting period. Therefore, we are 

proposing 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, 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 

are proposing 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 propose 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 

propose to revise § 413.70(a)(6)(ii) to 

state that the 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 

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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. 

Finally, we are proposing an 

additional exception in this proposed 

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. 

As described previously, we are 

proposing 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 that 

EHR reporting period (or November 

30th of the subsequent EHR reporting 

period) otherwise the payment penalty 

could be applied to the CAH’s cost 

reporting period that begins in that 

payment adjustment year. We are 

proposing 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, a CAH will be subject 

to the payment penalty 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 

the payment penalty will be applied. 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. 

Table 15, 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. 

TABLE 15—TIMELINE FOR CAHS TO AVOID PAYMENT ADJUSTMENT

CAH with cost reporting 

period beginning during 

payment adjustment 

year: 

Establish meaningful use for the 

EHR reporting period: OR 

For a CAH demonstrating meaningful use 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. 

5. Proposed Administrative Review 

Process of Certain Electronic Health 

Record Incentive Program 

Determinations 

The Stage 1 final rule established 

requirements in 42 CFR 495.370 for 

States to create appeals processes under 

the Medicaid EHR Incentive Program, 

but did not establish an appeal process 

for all of the EHR Incentive Program. In 

§ 495.404, we are proposing a process 

for Medicare EPs, eligible hospitals, 

CAHs, qualifying MA organizations on 

behalf of an EP, and qualifying MAaffiliated hospitals in a limited 

circumstance to file an appeal in the 

Medicare FFS EHR Incentive Program. 

(See proposed § 495.213 of the 

regulations text for a discussion of the 

appeal process proposed for the MA 

EHR Incentive Program). In § 495.404(f), 

we are proposing an appeal process for 

Medicaid providers in a limited 

circumstance, specifically when we 

conduct a meaningful use audit of the 

Medicaid eligible hospital and make an 

adverse audit finding. 

Although 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), we 

believe a limited appeal process is 

warranted in certain cases involving 

individual applicability; that is, where a 

provider, as defined in § 495.400, is 

challenging not the standards and 

methods themselves, but whether the 

provider met the regulatory standards 

and methods promulgated by CMS in its 

rules. 

The proposed administrative appeals 

process applies to both Stage 1 and 

Stage 2 of meaningful use. We will post 

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 seek public 

comments both on the guidance and the 

proposed rule. 

We note that in all cases, we would 

require that requests for appeals, all 

filings, and all supporting 

documentation and data be submitted 

through an online mechanism in a 

manner specified by CMS. 

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a. Permissible Appeals 

We propose to limit permissible 

appeals to the following three types of 

appeals: 

(1) Eligibility Appeals 

These appeals could be filed by EPs, 

eligible hospitals, or CAHs. The 

provider would need to demonstrate 

that it meets all the EHR Incentive 

Program requirements except for the 

issue raised and should have received a 

payment but could not because of a 

circumstance outside the provider’s 

control. A circumstance outside a 

provider’s control is any event, as 

defined by us, which reasonably 

prevented a provider from participating 

in the EHR Incentive Program, and 

which the provider could not under any 

circumstance control. For example, 

system issues wholly within the control 

of CMS that could not be resolved to 

allow a provider to participate in the 

EHR Incentive Program or natural 

disasters that prevent the provider from 

registering or attesting might be 

circumstances outside the control of the 

provider, depending upon the specific 

situation. 

In limited circumstances, an MAaffiliated eligible hospital could also file 

an eligibility appeal based on common 

corporate governance with a qualifying 

MA organization, for which at least two 

thirds of the Medicare hospital 

discharges (or bed-days) are of (or for) 

Medicare individuals enrolled under 

MA plans or whether it meets the 

requirement of section 1853(m)(3)(B)(i) 

of the Act to be an MA-affiliated 

hospital because it has less than onethird of Medicare bed-days covered 

under Part A rather than Part C. 

(2) Meaningful Use Appeals 

These appeals could be filed by EPs, 

eligible hospitals, CAHs, and MA 

organizations on behalf of MA providers 

to challenge adverse audit or other 

findings that the provider did not, in 

fact, demonstrate that it is a meaningful 

EHR user, or, that it did not demonstrate 

it was using certified EHR technology. 

(See section II.F. of this proposed rule, 

explaining proposed amendments to 

§ 495.316 and § 495.332). These appeals 

could be filed by Medicaid providers in 

a limited circumstance, specifically 

when we conduct a meaningful use 

audit of the Medicaid eligible hospital 

and make an adverse audit finding. 

States would agree in their State 

Medicaid Health Information 

Technology Plans (SMHPs) to be bound 

by our audit and appeal determinations 

on meaningful use). Medicaid EPs 

would continue to use the State appeal 

process for all appeals under the 

Medicaid EHR Incentive Program. 

(3) Incentive Payment Appeals 

These appeals could be filed by 

Medicare EPs. The appeal would need 

to challenge the claims count used at 

attestation for determining the incentive 

payment. The appeal could not contest 

an individual claims payment or 

coverage decisions, but only the 

inclusion of final claims used to 

calculate the incentive payment 

amount. The appeal could also 

challenge a recoupment of an incorrect 

incentive payment based on any Federal 

determination (including a recoupment 

based on duplicative payment). Any 

issue involving incentive payment 

based upon a hospital cost report must 

be filed with the Provider 

Reimbursement and Review Board 

(PRRB); thus appeals raising hospital 

cost report issues will be dismissed in 

accordance with these proposed rules. 

However, we wish to make clear that the 

PRRB would not have jurisdiction over 

issues to be decided under the 

administrative process described in this 

proposal (for example, eligibility issues 

or whether a provider was a meaningful 

EHR user). 

b. Filing Requirements 

(1) Filing Deadlines 

Appeals filed by a provider after the 

specified deadline would be dismissed 

and could not be re-filed, except under 

extenuating circumstances. If the filing 

deadline falls on a Saturday, Sunday, or 

a Federal holiday, then, the filing 

deadline would be extended to the next 

business day. We propose the following 

filing deadlines for each appeal: 

• An eligibility appeal must be filed 

no later than 30 days after the 2-month 

period following the payment year. 

• A meaningful use appeal must be 

filed no later than 30 days from the date 

of the demand letter or other finding 

that could result in the recoupment of 

an EHR incentive payment. 

• An incentive payment appeal must 

be filed no later than 60 days from the 

date the incentive payment was issued 

or 60 days from any Federal 

determination that the incentive 

payment calculation was incorrect 

(including determinations that 

payments were duplicative). 

A provider could request to extend 

the filing deadline by showing 

extenuating circumstances existed, 

which prevented the provider from 

filing the appeal by the applicable 

deadline. To demonstrate extenuating 

circumstances, a provider would need 

to present documentation (in its late 

filing) that occurrences, events, or 

transactions prevented the provider 

from filing by the applicable deadline. 

Extenuating circumstances will be 

decided on a case-by-case basis. 

Extenuating circumstances include, but 

are not limited to, system issues that 

affect a provider’s incentive payment. 

We may extend the filing deadline for 

providers in response to extenuating 

circumstances that occur within the 

EHR Incentive Program. We will 

provide information on our Web site at 

least 7 calendar days before the filing 

deadline providing the new filing 

deadline. 

A provider could withdraw an appeal 

at any time after the initial appeal filing 

and before an informal review decision 

is issued. The issues raised in the 

appeal filing could be refiled by the 

provider if prior to the specified filing 

deadline as specified in § 495.408(b). 

(2) Issues Raised at Time of Filing 

A provider would be required to raise 

all relevant issues at the time of the 

initial filing of an appeal. Except under 

extenuating circumstances, issues not 

raised at the initial appeal filing could 

not be raised at a later time and would 

be dismissed. To demonstrate 

extenuating circumstances, a provider 

would need to show (in its amendment 

filing) that circumstances beyond the 

provider’s control prevented all relevant 

issues from being included at the time 

of the initial appeal filing. For example, 

the provider received documentation 

from another entity after the initial 

appeal filing, which raised additional 

issues that should have been included 

in the initial appeal filing. The provider 

would be required to provide (with its 

amendment filing) documentation of 

occurrences, events, or transactions that 

prevented the additional issues from 

being raised at the initial appeal filing. 

We propose that any amendment must 

be filed no later than 15 days after the 

initial appeal filing deadline. 

c. Preclusion of Administrative and 

Judicial Review 

Any provider using our 

administrative appeal process would 

have the burden of showing at the time 

of the initial appeal filing that any issue 

raised in the appeal is not precluded 

from administrative and judicial review 

under the HITECH Act and our 

regulations at 42 CFR 413.70(a)(7), 

495.106(f), 495.110, 495.212. Appeal 

issues found to be precluded would be 

dismissed. 

d. Inchoate Review 

We propose that issues raised in an 

appeal would also be reviewed for 

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premature or inchoate issues. Issues are 

considered inchoate or premature if a 

provider is challenging a program issue 

that we still have an opportunity to 

resolve before the end of the respective 

payment period as indicated in the 

filing deadlines. The provider would 

have the burden of demonstrating in the 

initial appeal filing that the provider 

allowed us an opportunity to resolve the 

issue, and provide documentation of 

such resolution efforts (for example, 

documentation from contacting the EHR 

Information Center and demonstrating 

the issue was still not resolved or a 

demand letter has been issued asking for 

recoupment of an incentive payment.) A 

provider that is unable to meet the 

burden would have their appeal 

dismissed and have the opportunity to 

refile when the provider can 

demonstrate: (1) That it has met all the 

program requirements other than the 

issue raised and should have received 

an incentive payment; (2) CMS was not 

able to resolve the issue before the end 

of the payment year; and (3) the appeal 

challenges the same program issues 

from the dismissed inchoate or 

premature appeal and is filed no later 

than 30 days after the 2-month period 

following the payment year for which 

the initial appeal was filed. 

e. Informal Review Process Standards 

Properly filed appeals (using the filing 

rules discussed previously) would first 

be subject to informal review, in 

accordance with the following process 

and standards: For eligibility appeals, 

the provider would be required to 

demonstrate at the initial appeal filing 

that it meets all of the requirements of 

the EHR Incentive Program except for 

the issue raised, that the issue raised 

was the result of a circumstance outside 

of the provider’s control that prevented 

the provider from receiving an incentive 

payment, and submit evidence that the 

provider took action to participate in the 

EHR Incentive Program. We are also 

proposing special rules for MA-affiliated 

hospitals appealing determinations 

regarding common corporate 

governance with a qualifying MA 

organization, for which at least twothirds of the Medicare hospital 

discharges (or bed-days) are of (or for) 

Medicare individuals enrolled under 

MA plans or that the hospital has less 

than one-third of Medicare bed-days for 

the year covered under Part A rather 

than Part C. 

For meaningful use appeals, the 

provider would be required to 

demonstrate that it met the meaningful 

use objectives and associated measures 

discussed in the demand letter issued 

by CMS or other findings that could 

result in a recoupment of the EHR 

incentive payment and that the provider 

used certified EHR technology during 

the EHR reporting period for the 

payment year for which the appeal was 

filed. 

For incentive payment appeals, the 

provider would be required to 

demonstrate that all relevant claims 

were submitted timely, according to the 

requirements set forth in the EHR 

Incentive Program but that the timely 

and appropriately filed claims were not 

included in calculating the amount of 

the EHR incentive payment. The EHR 

Incentive Program requires all claims be 

filed no later than 2 months after the 

end of the payment year. Nevertheless, 

we believe there may be situations in 

which timely filed claims are not 

reflected in our integrated data 

repository (IDR) due to claims 

processing delays. In this case, we will 

nevertheless calculate incentive 

payments based on the allowed charges 

for covered professional services 

included in the IDR (by our deadline for 

making incentive payments). However, 

EPs will be able to file appeals of these 

payment amounts, if they can show that 

timely filed claims were not included in 

the calculation, and that they would 

have received a higher incentive 

payment had such claims been 

included. We believe that at the time 

such appeals are filed, the IDR will have 

more up-to-date information, thereby 

allowing us to determine these appeals 

based on the allowed charges for the 

timely filed claims. 

f. Request for Supporting 

Documentation—Documentation 

Essential To Validate an Issue Raised in 

the Appeal 

We propose that providers would 

have 7 calendar days to comply with the 

request for supporting documentation. 

Missing this 7-day deadline would 

result in dismissal of the appeal, except 

in extenuating circumstances. A 

provider would be required to 

demonstrate that extenuating 

circumstance existed that prevented the 

provider from submitting supporting 

documentation within the required 7- 

day deadline. Extenuating 

circumstances would be decided on a 

case-by-case basis, for example, if a 

provider received documentation from 

another entity after the 7 calendar days 

to respond to the request for supporting 

documentation. 

g. Informal Review Decision 

We propose that an informal review 

decision would be rendered within 90 

days after the initial appeal filing, 

unless extensions or amendments are 

granted. 

h. Final Reconsideration 

We propose that providers dissatisfied 

with an informal review decision could 

file a request for reconsideration of 

issues denied in the informal review 

decision. All comments and 

documentation supporting the 

provider’s position that the issues 

denied in the appeal should have been 

approved would be required to be 

submitted within 15 days from the date 

of the informal review decision. 

Requests for reconsideration would be 

reviewed with the same standards of 

review as the informal review. One-time 

extensions of 15 additional days could 

be requested, if the provider could 

demonstrate that it did not receive the 

informal review decision within 5 days 

of the date on the informal review 

decision. 

We would render a final decision on 

the request for reconsideration within 

10 days after the request for 

reconsideration and all supporting 

documentation and data are received. 

If the provider does not request 

reconsideration, the informal review 

decision is a final decision by CMS. 

i. Exhaustion of Administrative Review 

We expect all providers to exhaust the 

administrative review process proposed 

in this rule, prior to seeking review in 

Federal Court. 

E. Medicare Advantage Organization 

Incentive Payments 

1. Definitions (§ 495.200) 

We propose to add definitions of the 

terms ‘‘Adverse eligibility 

determination,’’ ‘‘Adverse payment 

determination’’ and ‘‘MA payment 

adjustment year.’’ Please see the 

discussion in section II.E.5 of this 

proposed rule. We also would 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 propose 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 

qualifying MA organizations might be 

considered ‘‘hospital based’’ solely on 

the basis of the fact that 90 percent of 

their FFS covered professional services 

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were provided in a hospital setting. For 

example, a qualifying MA EP might bill 

FFS 10 times over a year because of 

emergency room services provided to 

various patients. Although the vast 

majority of the MA EP’s covered 

services were reimbursed under his or 

her arrangement with the MA 

organization, 100 percent (or 10) of the 

MA EP’s FFS covered services would be 

for hospital-based services, which 

would otherwise prohibit the MA 

organization from receiving 

reimbursement under the MA EHR 

incentive program for the MA EP. We do 

not believe we should exclude MA EPs 

from the MA EHR Incentive Program 

due to only a few FFS claims. In 

addition, MA organizations may not 

have access to an MA EP’s FFS covered 

professional service data if the 

professional services were rendered 

outside of the employment arrangement 

between the qualifying MA organization 

and the qualifying MA EP. Therefore, 

we are clarifying in the definition of 

‘‘qualifying MA EP’’ 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. 

2. Identification of Qualifying MA 

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

We propose a technical change to 

§ 495.202(b)(1) to indicate that the 

qualifying MA organizations must 

identify those MA EPs and MAaffiliated eligible hospitals that the 

qualifying MA organization believes 

will be meaningful users of certified 

EHR technology during the reporting 

period, if a qualifying MA organization 

intends to claim an incentive payment 

for a given qualifying MA EP or MAaffiliated eligible hospital. 

In § 495.202(b)(2), we clarify that 

qualifying MA organizations must 

report the CMS Certification Number 

(CCN) for qualifying MA-affiliated 

eligible hospitals. As this program 

matures, this is a detail that became 

necessary to report in order to properly 

administer the program. 

We propose a new § 495.202(b)(3) to 

include a reporting requirement to 

ensure that we can identify which 

qualifying MA EPs a given qualifying 

MA organization believes have 

furnished more than 50 percent of his or 

her 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 

propose to redesignate the current 

§ 495.202(b)(3) as (b)(4), and revise the 

introductory language in (b)(2) to reflect 

this redesignation. 

We require in the current 

§ 495.202(b)(3) that MA organizations 

identify qualifying MA EPs or MAaffiliated eligible hospitals within 60 

days of the close of the payment year. 

We are proposing to change the 60-day 

requirement to a 2-month requirement 

in order to be more consistent with the 

Medicare FFS EHR Incentive Program. 

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 are proposing 

conforming amendments to 

§ 495.204(b)(2) and § 495.210(b) and (c). 

Because the redesignated § 495.202 

(b)(4) relates to both the payment phase 

and the payment adjustment phase of 

the program, we added the word 

‘‘qualifying’’ to the text of the 

regulation. Therefore this regulation 

applies to both qualifying MA EPs and 

MA-affiliated eligible hospitals 

(payment and payment adjustment 

phases) and potentially qualifying MA 

EPs and MA-affiliated eligible hospitals 

(payment adjustment phase) of the 

program. 

We redesignated the current 

§ 495.202(b)(4) as § 495.202(b)(5), and 

indicated that the qualifying MA 

organization must identify the MA EPs 

and MA-affiliated eligible hospitals that 

it believes will be both ‘‘qualifying’’ and 

‘‘potentially qualifying.’’ In order to 

calculate the payment adjustment, we 

will need to know how many qualifying 

MA EPs and MA-affiliated eligible 

hospitals are and are not meaningful 

users. We also propose to correct a 

cross-reference. 

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 propose to clarify 

that methods relating to overhead costs 

may be submitted for MA EPs regardless 

of whether the MA EP is salaried or paid 

in another fashion, such as on a 

capitated basis, where appropriate. 

As stated previously, we also propose 

to require MA organizations, to submit 

revenue amounts relating to their 

qualifying MA EPs within 2 months of 

the close of the calendar year, as 

opposed to 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) (the current 

paragraph (e) would be redesignated 

paragraph (f)), we propose to add a 

provision governing whether a 

qualifying MA organization is entitled 

to a HPSA increase for a given 

qualifying MA EP. 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 if the MA EP 

predominantly furnishes his or her 

covered professional services during the 

MA EHR payment year in a geographic 

HPSA. Consistent with the Medicare 

FFS EHR Incentive Program, we 

interpret the term ‘‘predominantly’’ to 

mean more than 50 percent. For the MA 

EHR Incentive Program, we propose 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. 

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. In order for 

the MA organization to receive the 10 

percent increase, the MA EP would 

need 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 would 

need to provide more than $24,000 of 

Medicare Part B covered professional 

services to MA plan enrollees of the 

qualifying MA organization in order to 

begin earning the HPSA bonus—up to 

$26,400 to earn the maximum HPSAenhanced bonus of $19,800 for first 

payment years 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 MAO with respect to the 

MA EP were 2011 or 2012. If an MA 

organization can 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, the MA 

organization could receive the entire 

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$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 are proposing a conforming 

amendment in § 495.202(b)(2)(ii) to 

require MA organizations to notify CMS 

whether the qualifying MA EP 

predominantly provides covered 

services to MA plan enrollees in a 

HPSA. 

We also would add a new paragraph 

(5) to redesignated paragraph (f). This 

new paragraph (5) would clarify that 

if—(1) A qualifying MA EP; (2) an entity 

that employs a qualifying MA EP (or in 

which a qualifying MA EP has a 

partnership interest); (3) an MAaffiliated eligible hospital; or (4) any 

other party contracting with the 

qualifying MA organization, fails to 

comply with an audit request to 

produce documents or data needed to 

audit the validity of an EHR incentive 

payment, we will recoup the EHR 

incentive payment related to the 

applicable documents or data not 

produced. While we believe that we 

presently have the authority to do this 

under the current § 495.204(e)(4), (to be 

redesignated as (f)(4)), we believe it 

would be helpful for the regulations to 

specifically address what happens in 

the case of a failure to produce 

documents or data related to an audit 

request. 

We propose to add a new paragraph 

(g) to § 495.204 to clarify that in the 

unlikely event we pay a qualifying MA 

organization for a qualifying MA EP, 

and it is later determined that the MA 

EP—(1) Is entitled to a full incentive 

payment under the Medicare FFS EHR 

Incentive Program; or (2) has received 

payment under the Medicaid EHR 

Incentive Program, we will recover the 

funds paid to the qualifying MA 

organization for such an MA EP from 

the MA organization. (The former 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 by FFS to have earned the 

full amount. 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 now due.) If the 

organization still has an MA contract, 

we will recoup the amount from the MA 

organization’s monthly payment under 

section 1853(a)(1)(A) of the Act. If the 

organization no longer has an MA 

contract, we will recoup any amounts 

through other means, such as formal 

collection. As duplicate and 

overpayments are prohibited by statute 

(sections 1853(l)(3)(B), 1853(m)(3)(B), 

1903(t)(2) of the Act), we would recover 

overpaid MA EHR incentive payments 

for all MA EHR payment years, 

including payment year 2011. 

We also clarify that, in accordance 

with statutory requirements, if it is 

determined that an MA organization has 

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 will 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 

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 

duplicate and overpayments are 

prohibited by statute, this rule applies 

beginning with payment year 2011. 

4. Avoiding Duplicate Payments 

Qualifying MA EPs are eligible for the 

Medicare FFS EHR incentive payment if 

they meet certain requirements under 

that program. However, an EHR 

incentive payment is only allowed 

under one program. We believe the 

requirement that MA organizations 

notify MA EPs that the MA organization 

intends to claim them for the MA EHR 

Incentive Program will minimize 

misunderstandings among MA EPs 

(particularly if they expect to receive an 

incentive payment under the Medicare 

FFS Incentive Program). It is important 

for MA EPs to understand certain 

aspects of the program such as when a 

qualifying MA organization claims an 

MA EP under the MA EHR Incentive 

Program and the MA EP is not entitled 

to a full FFS EHR Incentive payment, 

the MA organization would prevent a 

partial payment under the Medicare FFS 

EHR Incentive Program from being paid 

directly to the MA EP. 

We propose to require each qualifying 

MA organization to attest that it has 

notified the MA EPs it intends to claim. 

We propose 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 propose to revise 

§ 495.208 by adding—(1) A new 

paragraph (a) requiring 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) 

requiring qualifying MA organizations 

to notify MA EPs when they are 

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) requiring the qualifying 

MA organization to attest to CMS that 

these notification requirements have 

been satisfied by the MA organization. 

We also propose to redesignate the 

current paragraphs (a) through (c) of 

§ 495.208 as (d) through (f), respectively. 

As discussed previously, in a revised 

§ 495.210 we are proposing 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. 

5. Payment Adjustments Effective for 

2015 And Subsequent MA Payment 

Adjustment Years (§ 495.211). 

Beginning in 2015, the Act 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 are 

proposing to add a definition of ‘‘MA 

Payment Adjustment Year’’ to the 

definitions in § 495.200. The definition 

is needed in part because the payment 

adjustment phase of the MA EHR 

program continues indefinitely—beyond 

the last year for which MA EHR 

incentive payments can be made to 

qualifying MA organizations. 

Additionally, since we are proposing to 

operationalize MA EHR payment 

adjustments in a different manner than 

under the FFS Medicare program, we 

believe a definition is warranted. 

We are proposing that an MA 

organization must have 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 in order 

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 must continue to qualify 

for participation in the program as a 

‘‘qualifying MA organization’’ as 

defined for purposes of this program. 

Such a payment adjustment is also 

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conditioned on the qualifying MA 

organization having potentially 

qualifying MA EPs and MA-affiliated 

eligible hospitals for the respective 

payment adjustment years. We take this 

approach because we believe 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 has first demonstrated 

that it meets 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. Note that although MA EHR 

payment years for both MA EPs and 

MA-affiliated eligible hospitals can 

theoretically continue through 2016, the 

last first MA EHR payment year for 

which an MA organization can receive 

an EHR incentive payment is 2014 for 

MA EPs, and 2015 for MA-affiliated 

hospitals. 

Furthermore, we believe payment 

adjustments under section 1853 of the 

Act will have limited applicability in 

the MA EHR Incentive Program because 

the HITECH Act limits 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 are making incentive payments, and 

the phase of the program when we are 

adjusting payments under sections 

1853(l)(4) and 1853(m)(4) of the Act). 

Section 1853(l)(5) of the Act limits 

which MA organizations may 

participate by defining the term 

‘‘qualifying MA organization.’’ 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. 1395w23(l)(5)). The PHS Act 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 manner and to the same 

extent as such an HMO.’’ (See 42 U.S.C. 

300gg-91). 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. 

Organizations that do not meet the PHS 

definition of ‘‘HMO’’ cannot 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, 1853(l)(2) of the Act 

requires that MA EPs be as described in 

that paragraph. 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 do not expect 

many qualifying MA organizations to 

meet this test. 

The current § 495.202(b)(4) (which is 

being redesignated 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. This reporting 

requirement would include only 

qualifying MA organizations that 

participated in and received MA EHR 

incentive payments. 

There may be MA organizations that 

participated in the payment phase of the 

program that no longer, in practice, are 

qualifying MA organizations, or that no 

longer have qualifying MA EPs or MAaffiliated eligible hospitals. For 

example, if a qualifying MA 

organization that contracted with one 

entity to deliver physicians’ services 

during the payment phase of the EHR 

Incentive Program, loses its contract 

with that entity, or if the entity 

subsequently contracts with other MA 

organizations, the MA organization may 

no longer meet the basic requirements to 

participate in the program (that is, may 

no longer be subject to adjustments due 

to not meeting the 80/80/20 rule). (See 

§ 495.200, for the definition of 

‘‘Qualifying MA EP’’ in the Stage 1 final 

rule). Therefore, 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 would adjust payments 

beginning for payment adjustment year 

2015 only for qualifying MA 

organizations that received MA EHR 

payments and that have potentially 

qualifying MA EPs or MA-affiliated 

eligible hospitals that are not 

meaningful EHR users. We would rely 

on the existing self-reporting 

requirement in redesignated 

§ 495.202(b)(5) and subsequent audits to 

ensure compliance. 

We propose 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 will 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 are 

proposing 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 will also need to finally 

identify such MA EPs and MA-affiliated 

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 will 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 will obviate an 

adjustment. Through audit we will 

verify the accuracy of an applicable MA 

organization’s assertions or 

nonreporting. 

We are proposing 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 

attests to the percent of hospitals and 

professionals that either are or are not 

meaningful users of certified EHR 

technology. To the extent a formerly 

qualifying MA organization does not 

report under § 495.202(b)(4) or (5), we 

would verify, upon audit, the accuracy 

of the applicable MA organization’s 

nondisclosure of 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. An MAaffiliated eligible hospital must attest to 

meaningful use by November 30th. 

Therefore, 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 

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specific MA organization. Although we 

expect (and prefer) to make an 

adjustment to one MA monthly payment 

totaling the adjustment for the year, we 

request comments on whether more 

than one monthly payment should be 

adjusted. One possible approach would 

be to make this decision on a case-bycase basis depending upon a given 

qualifying MA organization’s situation 

(for example, payment adjustment 

amount versus MA organization’s 

monthly payment). 

For payment adjustments based on 

potentially qualifying MA EPs that are 

not meaningful users of certified EHR 

technology, we also propose 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 

could calculate the payment adjustment 

based on the prior MA payment year’s 

payment, and apply that adjustment to 

one or more of the prospective Part C 

payments. While we prefer to make an 

adjustment to one MA prospective 

payment for the full amount of the 

payment adjustment when possible, we 

solicit comment on whether we should 

make adjustments over several months 

or in a single month (for the entire 

adjustment amount), 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 for 2015. 

However, while the payment adjustment 

for the 2015 payment adjustment year 

would be collected as soon as possible, 

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. 

Proposed § 495.211(c) makes clear 

that the potentially qualifying MA EP 

and MA-affiliated eligible hospital 

payment adjustments are calculated 

separately, and that each adjustment is 

applied to the qualifying MA 

organization’s monthly payment under 

section 1853(a)(1)(A) of the Act, as 

discussed previously. 

While 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 

are not meaningful users of certified 

EHR technology. This paragraph makes 

clear that if a potentially qualifying MA 

EP is not a meaningful user of certified 

EHR technology in payment adjustment 

year 2015 (and subsequent payment 

adjustment years), the qualifying MA 

organization’s monthly Part C payment 

may 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 are 

claiming. During the payment 

adjustment phase of this program, we 

would need to know the percentage of 

both qualifying and potentially 

qualifying MA EPs and MA-affiliated 

eligible hospitals that are not 

meaningful users of certified EHR 

technology. This percentage can 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 are not meaningful EHR users. We 

would use this percentage to make the 

adjustment proportional to the percent 

that are 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 

are not meaningful users), we would 

exclude EPs and hospitals that were 

neither qualifying nor potentially 

qualifying MA EPs 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 is a 

hospital-based EP would not be a 

qualifying or potentially qualifying MA 

EP since such an EP does not meet the 

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. The 

formula we are proposing for purposes 

of applying the payment adjustments 

proposed in § 495.211(d)(2) with respect 

to MA EPs is: 

[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 are 

proposing for purposes of applying 

payment adjustments in 

§ 495.211(e)(2)(iii) with respect to MAaffiliated hospitals is: 

[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) require 

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 are asking for 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. Commenters should 

take into account that MA-affiliated 

eligible hospitals may still be required 

to perform a reporting function on 

behalf of their MA-affiliated 

organization in the National Level 

Repository (NLR), and are generally 

bound to ‘‘subsection (d)’’ hospital 

reporting requirements of the NLR, so 

we are primarily interested in 

stakeholders’ thoughts on the 

requirements related to MA EPs. 

While we wish to minimize burden, 

we are concerned about our ability to 

audit the information reported to ensure 

compliance with MA program 

requirements. Therefore, should we 

adopt the proposal in the final rule to 

require qualifying MA organizations to 

report only a percentage of MA EPs and 

MA-affiliated hospitals that are not 

meaningful users along with identifying 

information in § 495.202(b)(2)(i) through 

(iii), we also propose to require such 

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 propose that payment adjustments 

for MA EPs be calculated by 

multiplying: (1) The percent established 

under § 495.211(d)(4) of this proposed 

rule, (which 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 are not 

meaningful users. The statute at section 

1853(l)(4)(B)(i) of the Act says that the 

‘‘percentage points’’ in section 

1848(a)(7)(A)(ii) of the Act apply to 

qualifying MA organizations with 

potentially qualifying MA EPs that are 

not meaningful users. We would also 

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apply the additional reductions required 

under section 1848(a)(7)(A)(iii) of the 

Act to MA payment adjustments. We 

propose 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, 5 percent in 2019 and 

subsequent years. We also note that we 

have not proposed the possibility of a 2 

percent reduction for 2015 (consistent 

with the Medicare FFS EHR Incentive 

Program), because that increased 

reduction applies in the case of EPs that 

were subject to an adjustment in 2014 

under the e-prescribing program. MA 

organizations are not independently 

subject to the e-prescribing payment 

adjustments. Proposed regulations may 

be found in § 495.211(d)(4)(iv) through 

(vi). 

The Medicare Physician 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 

physician services. While this 

proportion would be uniform across all 

MA organizations, in accordance with 

the requirement in section 1853(l)(1) of 

the Act that payment adjustments be 

with respect to the eligible professionals 

described in paragraph (2) of 1853(l) of 

the Act, we also propose 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. 

Therefore, we would adjust each MA 

organization’s Physician Expenditure 

Proportion to recognize that not all of 

the EPs would meet the nonmeaningful 

use requirements to be potentially 

qualifying or qualifying MA EPs. For 

example, not all EPs might furnish 80 

percent of their Title XVIII professional 

services to enrollees of the qualifying 

MA organization. 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. 

An example of our proposed MA 

payment adjustment for adjustment year 

2015 is 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. 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. 

The formula would result in an 

adjustment that is 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. 

The percentage point reduction 

specified by section 1886(b)(3)(B)(ix)(I) 

of the Act is based on the point 

reduction that results when threefourths of the otherwise applicable 

percentage increase for the fiscal year is 

reduced by 331⁄3 percent for FY 2015, 

662⁄3 percent for FY 2016, and 100 

percent for FY 2017 and subsequent 

fiscal years. This has 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). 

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. As 

mentioned previously, we propose that 

this proportion reflect only the MAaffiliated eligible hospitals that are 

either qualifying or potentially 

qualifying MA-affiliated eligible 

hospitals. 

We also propose to use the market 

basket percentage increase that would 

otherwise apply to ‘‘subsection (d)’’ 

hospitals for an MA payment 

adjustment year. A hypothetical 

example would be as follows. The 

market basket percentage increase for 

FY 2015 is hypothetically 4 percent. 

Three-quarters of one-third of 4 percent 

would be 1 percent. The hypothetical 

Medicare Hospital Expenditure 

proportion for the year is 15 percent, 

and one of two of the relevant MAaffiliated eligible hospitals is not a 

meaningful EHR user for the applicable 

period (FY 2015). The monthly payment 

to the MA organization in 2015 is 

$10,000,000 a month. 

The calculation would be as follows: 

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 request 

comment on this aspect of the proposed 

rule. 

6. Reconsideration Process for MA 

Organizations 

We propose a new section, § 495.213, 

which would set forth a reconsideration 

process for qualifying MA organizations 

that participate in the MA EHR 

Incentive Program. Under our proposal 

certain MA organization 

reconsiderations would be heard under 

the appeal process proposed in section 

II.D.5. of this proposed rule, while 

others would be heard using the process 

described in this section. This would 

allow us to take advantage of another 

reconsideration mechanism, and ensure 

consistency in decision-making for 

reconsiderations relating to, for 

example, meaningful use 

determinations. 

Although the HITECH Act prohibits 

both administrative and judicial review 

of the standards and methods used to 

determine eligibility and payment 

(sections 1853(l)(8) and (m)(6) of the 

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13786 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 

Act, and 42 CFR 495.212), we believe it 

is prudent to include a process for 

seeking reconsideration, in certain 

circumstances, of the application of 

those standards and methods. For 

eligibility issues, we would limit 

reconsiderations to those involving CMS 

system errors that did not allow the 

performance of a required function, and 

the qualifying MA organization or MAaffiliated eligible hospital missed a 

deadline (such as a registration or 

attestation deadline) because of such 

system malfunction. Thus, in § 495.200 

we define ‘‘Adverse eligibility 

determination’’ to include only 

determinations or omissions by CMS 

caused by a malfunction of a CMS 

system. 

For qualifying MA-affiliated eligible 

hospitals (either acting on behalf of the 

qualifying MA organization or where 

the qualifying MA organization acts on 

the hospitals’ behalf), we would require 

using the reconsideration process 

established for hospitals under the FFS 

EHR Incentive Program (described in 

section II.D.5. of this proposed rule). 

Reconsiderations of adverse meaningful 

use audits would also be heard using 

the process described in section II.D.5. 

of this proposed rule. 

The remainder of this preamble 

discussion relates to reconsiderations 

involving eligibility and payment issues 

for MA EPs. We would conduct 

reconsiderations of the application of 

payment requirements to, and eligibility 

requirements to participate in the 

program by a given MA EP under this 

section. We also request comment as to 

other issues that may require 

reconsideration, including a discussion 

of whether the issues are within our 

control. For example, if a qualifying MA 

organization’s system incorrectly reports 

the identities of its qualifying MA EPs 

to us, we do not believe this could be 

used as a ground for reconsideration, 

because such a determination would be 

outside of our control. Of course, if a 

qualifying MA organization overreports, we will recoup the applicable 

funds related to the over-reporting. 

We request comment on defining the 

terms ‘‘adverse payment determination’’ 

and ‘‘adverse eligibility determination.’’ 

We preliminarily believe the term 

‘‘adverse eligibility determination’’ 

should be defined as ‘‘a determination 

or omission by CMS that prohibits a 

qualifying MA organization from 

participating in the EHR Incentive 

Program, that a representative of the MA 

organization believes was the result of a 

malfunction of a CMS system.’’ We 

preliminarily believe the term ‘‘adverse 

payment determination’’ should be 

defined as ‘‘a determination by CMS 

that negatively affects an EHR payment 

determination.’’ 

We also propose to hear 

reconsiderations of payment adjustment 

amounts, when that phase of the 

program occurs. 

We propose a two-level 

reconsideration process. The first level 

would be a request for an informal 

reconsideration. The second level 

would be a final reconsideration. 

Requests for informal reconsideration 

would need to be submitted within 60 

calendar days of an adverse eligibility or 

payment determination. If we find 

against the MA organization, it will 

have 30 calendar days from the date on 

the informal reconsideration decision to 

file a request for final reconsideration. If 

the 30th or 60th calendar day (as 

applicable) is a Saturday, Sunday, or a 

Federal holiday, the reconsideration 

request will be due by the next business 

day. The MA organization would be 

required to submit all evidence and data 

in the initial request for informal 

reconsideration; no new evidence or 

data would be permitted at the final 

reconsideration stage. An MA 

organization could not use the 

reconsideration process to submit new 

payment-related information. Failure to 

file an informal or final reconsideration 

request pursuant to this CMS process 

would result in eligibility or payment 

determinations becoming final and 

binding, absent CMS reopening due to 

audit or other evidence of material 

misrepresentation. 

F. Proposed Revisions and Clarifications 

to the Medicaid EHR Incentive Program 

The proposals discussed in this 

section of the proposed rule would take 

effect upon finalization of this rule, not 

when Stage 2 of meaningful use of 

certified EHR technology takes effect. 

1. Net Average Allowable Costs 

In this proposed 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 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 propose 

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. 

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TABLE 16—DETERMINATION OF NET AVERAGE ALLOWABLE COSTS FOR THE FIRST PAYMENT YEAR

First year variables1 Amounts Prior to extenders act changes Currently 

Average Allowable Costs ............... $54,000 ......................................... Determined through a CMS metaanalysis, 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. 

1.These 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. 2.This figure is further reduced to two-thirds for pediatricians qualifying with reduced Medicaid patient volumes. This is described at 42 CFR 

495.310. 

2. Eligibility Requirements for 

Children’s Hospitals 

We propose 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 that 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. 

3. Medicaid Professionals Program 

Eligibility 

Section 1903(t) of the Act authorizes 

Medicaid payments to encourage the 

adoption and use of certified EHR 

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 for care of 

Medicaid populations. Otherwise, 

Medicaid funding could potentially be 

used to fund adoption and use of 

technology that does not benefit the 

Medicaid population directly. 

Therefore, we propose that at least one 

of the clinical locations used for the 

calculation of an EPs’ patient volume 

have certified EHR technology during 

the payment year for which the EP is 

attesting to adopt, implement or 

upgrade in their first participation year, 

or to meaningful use in subsequent 

years. This will ensure that EPs receive 

Medicaid funding for certified EHR 

technology that is used on behalf of the 

EP’s Medicaid patients. We have 

amended § 495.304 and § 495.332 

accordingly. 

a. Calculating Patient Volume 

Requirements 

We propose to revise § 495.306 (c) to 

allow States the option for their 

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. This option would 

be in addition to the current regulatory 

language basing patient volume on the 

prior calendar or fiscal year. We believe 

this adjustment would provide greater 

flexibility in eligible providers’ patient 

volume calculations. 

Likewise, we propose 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 1 Medicaid encounter took 

place with the Medicaid patient in the 

24 months prior to the beginning of the 

90-day period. Also, we propose to 

revise § 495.306(d)(1)(ii)(A) accordingly, 

so that the numerator and denominator 

are using equivalent periods. 

Conforming changes would be made to 

§ 495.306(d)(2)(i) and (ii) for needy 

individual patient volume. We are 

proposing these changes 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 propose 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.’’ 

We propose to expand the current 

definition of ‘‘encounter’’ to also 

include any service rendered on any one 

day to an individual ‘‘enrolled’’ in a 

Medicaid program. Such a definition 

would 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 all of the item 

or service or the service is not covered 

under Medicaid). The definition would 

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also 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 CHIP 

programs) could be counted in 

providers’ patient volume calculations. 

This approach is consistent with 

existing policies that provide Title XIX 

protections to children enrolled in Title 

XXI-funded Medicaid expansions. 

As of 2010, 33 States have Title XXI 

Medicaid expansions via approved State 

plan amendments. Therefore, 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 expect this change would 

increase the number of eligible 

providers who qualify for the Medicaid 

EHR Incentive Program, particularly 

those serving children. We expect that 

this change would represent an increase 

because States were more limited in 

their inclusion of Medicaid expansion 

populations based upon the July 28, 

2010 final rule. 

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 clarify 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. 

b. Practices Predominantly 

Similar to our proposed revisions for 

patient volume, we propose to revise the 

definition of ‘‘practices predominantly’’ 

at § 495.302. EPs could use either: (1) 

The most recent calendar year; or (2) the 

most recent 12 months prior to 

attestation. 

4. Medicaid Hospital Incentive Payment 

Calculation 

a. Discharge Related Amount 

In order to ensure that Medicaid 

regulations are consistent with 

Medicare, we are proposing 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/

downloads/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 are 

revising our policy 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 

would 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 is available. 

b. Acute Care Inpatient Bed Days and 

Discharges for the Medicaid Share and 

Discharge-Related Amount 

We currently require that only 

discharges from the acute care part of 

the hospital are allowable to be counted 

in both the discharge-related amount 

and the Medicaid share. For example, in 

response to a frequently asked question 

(available at https://questions.cms.hhs.

gov/app/answers/detail/a_id/10361) 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.’’ Also, we 

explained 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. 

In order to ensure that the regulations 

accurately reflect our current policy, we 

propose 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. 

Such regulatory amendments do not 

represent a change in policy but rather 

a clarification of existing policy. The 

Medicaid share would count only those 

days that would 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. 

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 1 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 would 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 

would then assume the second State’s 

payment cycle less the money that was 

paid from the first State. States should 

consult with us before addressing this 

specific scenario. 

5. Hospital Demonstrations of 

Meaningful Use—Auditing and Appeals 

We are proposing revisions to 

§ 495.316 under which we would 

conduct meaningful use audits and any 

subsequent appeals of such audits of 

any participating hospitals, including 

those that are eligible for only the 

Medicaid EHR Incentive program. In 

section 1903(t)(6)(C)(II) of the Act, all 

demonstrations of meaningful use must 

be ‘‘acceptable to the Secretary’’ and 

may be based upon methods that are 

adopted under the Medicare program in 

section 1886(n) of the Act. Thus, under 

this standard, we would require that all 

Medicaid hospitals would be subject to 

audit and appeal by CMS just for 

demonstrations of meaningful use. 

Therefore, States will continue to 

provide the remaining audit functions 

for requirements under the Medicaid 

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EHR Incentive Program. In addition (as 

discussed later), as we would be 

conducting the audit, hospitals would 

be subject to the CMS appeals process 

for any disputes regarding audit 

findings related to meaningful use, and 

States would be bound by our 

determinations regarding meaningful 

use findings. We have proposed to 

revise the SMHP requirements in 

§ 495.332 to clarify that States must 

indicate that if they are in agreement 

that they would be bound by our audit 

and appeal determinations in these 

circumstances. We also would revise 

our regulations at § 495.370 to make 

clear that appeals of adverse CMS audits 

would be subject to the CMS 

administrative appeals process and not 

the State administrative process. 

We believe it is essential for us to 

conduct the audits and appeals of 

hospital meaningful use because 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 successful, under the 

authority of section 1903(t)(8) of the 

Act, are deemed to have met the 

meaningful use requirements for 

Medicaid. This proposed revision 

would alleviate the burden on States 

developing processes, for which many 

States have indicated interest, and 

devoting resources to audit hospitals’ 

meaningful use attestations when we 

estimate that a majority of States would 

have two or fewer Medicaid-only 

hospitals apply for incentive payments. 

Instead, we would leverage the 

resources we would have already 

devoted to auditing the vast majority of 

hospitals eligible for both incentive 

programs, to include the approximately 

150 hospitals that are only eligible for 

Medicaid incentives. The meaningful 

use attestation data collected by States 

for the Medicaid-only eligible hospitals 

will be shared with our auditors to 

enable this process. We are not 

proposing to audit Medicaid eligible 

professionals because the anticipated 

number of Medicaid eligible 

professionals demonstrating meaningful 

use would not provide the same level of 

cost/resource efficiency. However, we 

are leveraging our work in designing 

and implementing Medicare EP 

meaningful use audits by sharing 

strategic approaches with States. States 

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 would also remain 

responsible for auditing EPs for 

compliance with meaningful use of 

certified EHR technology. 

Please note that right to audit 

discussed in this proposed rule is in 

addition to, and not in lieu of, any other 

applicable rights to audit, such as those 

held by the Office of the Inspector 

General (OIG). We do not intend for 

anything in this rule to limit or restrict 

the authority of another Federal agency 

or another office within the Department 

of Health & Human Services to audit, 

evaluate, investigate, or inspect. 

6. 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 are proposing 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 propose 

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 are not changing the requirements of 

the circumstances of ‘‘as needed’’ IAPD 

updates as defined by § 495.340. 

b. Requirements of States Transitioning 

from HIT Planning Advanced Planning 

Documents (P–APDs) to HIT IAPDs 

We are proposing the following 

process for States that have had an HIT 

P–APD approved by CMS, 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, the State 

should explain in a narrative format to 

be included in the HIT IAPD 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 to be ongoing 

during the implementation period, these 

planning activities must be included as 

line items within the HIT IAPD budget. 

III. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 60- 

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. 

We are soliciting public comment on 

each of these issues for the following 

sections of this document that contain 

information collection requirements 

(ICRs): 

This analysis serves as a revision to 

the existing PRA package approved 

under OMB control number 0938–1158. 

The following is a discussion of the new 

information collection requirements 

contained in this proposed regulation 

that we believe are subject to PRA. The 

projected numbers of EPs, eligible 

hospitals, and 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 

the section V of this proposed rule. The 

actual burden would remain constant 

for all of Stage 2 as the EHR reporting 

period would be the entire calendar year 

for EPs and Federal fiscal year for 

eligible hospitals and CAHs. The only 

variable from year to year in Stage 2 

would 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 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 

proposed rule. Beginning in 2012, 

Medicare EPs, eligible hospitals, and 

CAHs have the option to electronically 

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report their clinical quality measures 

through the respective electronic 

reporting pilots. The burden for the EP 

pilot is discussed in the CY 2012 

Medicare Physician Fee Schedule final 

rule with comment period (76 FR 73422 

through 73425). For eligible hospitals 

and CAHs, the burden is discussed in 

the CY 2012 Hospital Outpatient 

Prospective Payment final rule with 

comment period (76 FR 74489 through 

74492). 

A. ICR Regarding Demonstration of 

Meaningful Use Criteria (§ 495.6 and 

§ 495.8) 

In § 495.6, we propose that to 

successfully demonstrate meaningful 

use of certified EHR technology 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 certified EHR technology 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 

propose that providers must also 

successfully report the clinical quality 

measures selected by CMS to CMS or 

the States, as applicable. We estimate 

that the certified EHR technology 

adopted by the provider will 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 will enable the 

functionality required to complete the 

objectives and associated measures that 

require the provider to attest that they 

have done so. 

We propose 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 propose that 

eligible hospitals and CAHs would be 

required to report on a total of 16 core 

objectives and associated measures, 2 of 

4 menu set objectives and associated 

measures, and 24 clinical quality 

measures. 

There are 13 core objectives and up to 

2 menu set objectives that would require 

an EP to enter numerators and 

denominators during attestation. 

Eligible hospitals and CAHs would have 

to attest they have met 11 core 

objectives and 4 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 certified EHR technology. 

We do not anticipate a provider would 

maintain two recordkeeping systems 

when certified EHR technology is 

present. Therefore, we assume that all 

patient records that would be counted 

in the denominator would be kept using 

certified EHR technology. We expect it 

would 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 would require a ‘‘yes’’ or 

‘‘no’’ response during attestation. For 

eligible hospitals and CAHs, there are 4 

core objectives and that would require 

a ‘‘yes’’ or ‘‘no’’ response during 

attestation and no such menu set 

objectives. We expect that it would take 

a provider or their designee 1 minute to 

attest to each objective that requires a 

‘‘yes’’ or ‘‘no’’ response. 

Providers would 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 17 lists those objectives and 

associated measures for EPs and eligible 

hospitals and CAHs. We estimate the 

core set of objectives and associated 

measures will take an EP 8 hours 12 

minutes to complete, and will take an 

eligible hospital or CAH 7 hours 54 

minutes to complete. For EPs, we 

estimate the completion of 3 menu set 

objectives and associated measures will 

take between 3 minutes and 21 minutes 

to complete, depending on the 

combination of objectives they choose to 

attest to. For EPs, we estimate the 

selection, preparation, and electronic 

submission of the 12 ambulatory 

clinical quality measures would take 2 

hours. We estimate it would take 

eligible hospitals and CAHs 20 minutes 

to attest to the 2 menu set objectives 

they choose. For eligible hospitals and 

CAHs, we estimate the selection, 

preparation, and electronic submission 

of 24 required clinical quality measures 

would take 4 hours. 

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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 12 minutes to attest that 

during the EHR reporting period, they 

used the certified EHR technology, 

specify the EHR technology used and 

satisfied each of the applicable core 

objectives and associated measures. We 

estimate it will take an EP 21 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 no longer than 3 minutes. We 

also estimate that it will take an EP an 

additional 2 hours 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 33 

minutes. The total burden hours for an 

EP to attest to the least burdensome 

criteria previously specified is 10 hours 

15 minutes. We estimate that there 

could be approximately 537,600 nonhospital-based Medicare and Medicaid 

EPs in 2014. We anticipate 

approximately 37% (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 

requirement for an EP is 10 hours 33 

minutes (8 hours 12 minutes + 21 

minutes + 2 hours). 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 

$188,783,003 (198,912 EPs × 10 hours 

33 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 requirement for an EP is 10 

hours 15 minutes (8 hours 12 minutes 

+ 3 minutes + 2 hours). 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 $183,414,766 (198,912 EPs 

× 10 hours 15 minutes × $89.96 (mean 

hourly rate for physicians based on May 

2010 BLS data)). We invite public 

comments on the estimated percentages 

and numbers of (registered) EPs that 

will attest to the aforementioned criteria 

because such information would help us 

more accurately determine the burden 

on the EPs. 

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 54 minutes 

to attest that during the EHR reporting 

period, they used the certified EHR 

technology, 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 20 

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 4 hours 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 12 hours 14 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 proposed rule. We estimate 

the total burden associated with these 

requirements for an eligible hospital or 

CAH is 12 hours 14 minutes (7 hours 54 

minutes + 20 minutes + 4 hours). 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 $2,375,564 (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)). We invite public comments on 

the estimated percentages and numbers 

of (registered) eligible hospitals and 

CAHs that will attest to the 

aforementioned criteria because such 

information would help use more 

accurately determine the burden on the 

eligible hospitals and CAHs. We also 

invite comments on the type of 

personnel or staff that would most likely 

attest on behalf of the eligible hospital 

or CAH. 

B. ICRs Regarding Qualifying MA 

Organizations (§ 495.210) 

We estimate that the burden would 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 certified EHR technology 

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 certified 

EHR technology. In other words, 

qualifying MA organizations can make 

the determination en masse if the 

certified EHR technology 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 

professional, 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. 

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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 

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 

successfully attest ([210 hrs × 

$25.00] + [44 hrs × $59.00]). 

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 certified EHR technology 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. 

However, we are proposing 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 are 

proposing 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. Therefore, annual IAPD 

updates are only required if the State 

has not submitted an IAPD–U in the 

past 12 months, which we create less of 

a burden on the States. We expect that 

it would take a State 70 hours to update 

an annual IAPD. We believe that the 

proposed requirements 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, 

proposed alternatives for calculating 

patient volume will alleviate State 

burden as patient volume will be more 

easily calculated. 

TABLE 18—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 

incl. CQMs (EPs) ...................... 0938–New 198,912 198,912 8.20 1,631,078 $89.96 $146,731,812.86 

§ 495.6—Menu Set Objectives/ 

Measures (EPs) HIGH ............. 0938–New 198,912 198,912 0.35 69,619 89.96 6,262,943.23 

§ 495.6—Menu Set Objectives/ 

Measures (EPs) LOW .............. 0938–New 198,912 198,912 0.05 9,946 89.96 894,706.18 

§ 495.6—Menu Set Objectives/ 

Measures (EPs) AVERAGE ..... 0938–New 198,912 198,912 0.20 39,782 89.96 3,578,824.70 

§ 495.8—CQMs for EPs ............... 0938–New 198,912 198,912 2.00 397,824 89.96 35,788,247.04 

§ 495.6—EHR Technology Used, 

Core Set Objectives/Measures 

(hospitals/CAHs) ....................... 0938–New 2,696 2,696 7.90 21,298 62.23 1,325,399.43 

§ 495.6—Menu Set Objectives/ 

Measures (hospitals/CAHs) ...... 0938–New 2,696 2,696 0.33 890 89.96 80,035.61 

§ 495.8—CQMs for hospitals/ 

CAHs ........................................ 0938–New 2,696 2,696 4.00 10,784 89.96 970,128.64 

§ 495.210—Gather information for 

attestation (MA EPs) ................ 0938–New 13,000 13,000 0.75 9,750 25.00 243,750.00 

§ 495.210—Attesting on behalf of 

MA EPs .................................... 0938–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) ........ 0938–New 13,000 13,000 1.00 13,000 n/a 435,500.00 

§ 495.210—Gather information for 

attestation (MA-affiliated hospitals) ........................................ 0938–New 30 30 7.00 210 25.00 5,250.00 

§ 495.210—Attesting on behalf of 

MA-affiliated hospitals .............. 0938–New 30 30 1.48 44 59.00 2,619.60 

§ 495.210—Total cost of attestation for Stage 2 (MA-affiliated 

hospitals) .................................. 0938–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 ......................................... 0938–New 56 56 70.00 3,920 56.24 220,460.80 

Burden Total for 2014 ........... .................... .................... .................... .................... 2,118,831.28 .................... 189,138,279 

Note: All non-whole numbers in this table are rounded to 2 decimal places. 

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If you would like to comment on 

these information collection and 

recordkeeping requirements, please do 

either of the following: 

1. Submit your comments 

electronically as specified in the 

ADDRESSES section of this proposed rule; 

or 

2. Submit your comments to the 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Attention: CMS Desk Officer, 

[CMS–0044–P] Fax: (202) 395–6974; or 

Email: OIRA_submission@omb.eop.gov. 

IV. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the ‘‘DATES’’ section 

of this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

V. Regulatory Impact Analysis 

A. Statement of Need 

This proposed rule would 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 certified 

EHR technology. The proposed 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 proposed 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 proposed rule. 

As noted in section I. of this proposed 

rule, this proposed rule is one of two 

coordinated rules related to the 

adoption and meaningful use of 

certified EHR technology. The other is 

ONC’s proposed 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 2 requirements for 

meaningful use, the changes in quality 

measures that will take effect beginning 

in 2014, and other changes being 

proposed for 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 proposed provisions 

of the 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 certified EHR 

technology. Additionally, the Medicaid 

program also provides incentives for the 

adoption, implementation, and upgrade 

of certified EHR technology. 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 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 would 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 impossible to predict with 

precision the timing or rates of adoption 

and ultimately meaningful use. Further, 

little new data is currently available 

regarding rates of adoption or costs of 

implementation since the publication of 

our Stage 1 final rule. Because of this 

continued uncertainty and because 

there is little new data on which to base 

alternate forecasts, we are maintaining 

the high and low estimates for adoption 

rates that we established in our Stage 1 

final rule (75 FR 44548 through 44563). 

Therefore, we show two scenarios, 

which illustrate how different scenarios 

would impact overall costs. Our high 

scenario of meaningful use 

demonstration assumes that by 2019, 

nearly 100 percent of hospitals and 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. To emphasize the 

uncertainties involved, we have also 

created a low scenario estimate for the 

demonstration of meaningful use each 

year, which assumes less robust 

adoption and meaningful use. Our low 

scenario of meaningful use 

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demonstration assumes that by 2019, 

nearly 95.6 percent of hospitals and 36 

percent of EPs will be meaningful users. 

Data from the EHR Incentive Program 

to date has shown that about 4 percent 

of EPs and 8 percent of hospitals 

received incentive payments in 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. 2011 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 is not very 

useful in estimating penetration rates 

when stage 2 is implemented. 

Overall, we expect spending under 

the EHR incentive program for transfer 

payments to Medicare and Medicaid 

providers between 2014 and 2019 to be 

$3.3 billion under the low scenario, and 

$12.7 billion under the high scenario 

(these estimates include net payment 

adjustments for Medicare providers who 

do not achieve meaningful use in 2015 

and beyond in the amount of $3.9 

billion under the high scenario and $8.1 

billion under the low scenario). 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 

who would like to qualify as meaningful 

users of EHRs will need to purchase 

certified EHR technology. However, we 

believe that providers who have already 

purchased certified EHR technology and 

participated in Stage 1 of meaningful 

use will experience significantly lower 

costs for participation in the program. 

We continue to believe that the shortterm costs to demonstrate meaningful 

use of certified EHR technology 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 proposed rule. 

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 an Initial 

Regulatory Flexibility Analysis to 

describe and analyze the impact of the 

proposed 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 nonprofit 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 

(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 

Initial 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 non-certified 

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 Office of 

the National Coordinator for Health IT 

(ONC) and the American Hospital 

Association (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 Centers for Disease 

Control and Prevention (CDC) survey 

found the percentage of physicians who 

adopted basic electronic health records 

(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 45,000 

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 MAO physicians or 

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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 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 would 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 would 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 proposed rule 

would 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 proposed rule 

would 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 would arise from the 

implementation of certified EHR 

technology in a rural eligible hospital 

would 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 have proposed 

certain case-by-case applications that 

may be made when there are barriers to 

internet connectivity that would 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 would require 

spending in any 1 year $100 million in 

1995 dollars, updated annually for 

inflation. In 2011, that threshold is 

approximately $136 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 rule imposes no substantial 

mandates on States. This program is 

voluntary for States and States offer the 

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 

$136 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 

proposed rule that imposes substantial 

direct requirement costs on State and 

local governments, preempts State law, 

or otherwise has Federalism 

implications. This proposed rule would 

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 proposed 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 proposed 

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 criteria for the 

demonstration of meaningful use of 

certified EHR technology has been 

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finalized for stage 1 and is being 

proposed for stage 2, 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 570,300 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 non-physicians 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) would 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 proposed 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 would be $5 

million to achieve meaningful use, 

because providers who would like to 

qualify as meaningful users of EHRs will 

need to purchase certified EHRs. We 

further acknowledge that ‘‘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 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 propose 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. 

d. Costs of EHR Adoption for Eligible 

Hospitals 

The American Hospital Association 

(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 the smallest of 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, 

administrative costs related to reporting, 

and the like are unknown at this time 

and difficult to quantify. 

4. Medicare Incentive Program Costs 

a. Medicare Eligible Professionals 

(EPs) 

We propose to 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 

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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 

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 would 

qualify for Medicaid incentive payments 

and would 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 certified 

EHR technology are uncertain. The 

percentage of Medicare EPs who will 

satisfy the criteria for demonstrating 

meaningful use of certified EHR 

technology 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 certified 

EHR technology over the period CYs 

2014 through 2019 is as shown in Table 

19. 

TABLE 19—MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY, HIGH AND LOW

SCENARIO

Calendar year 

2014 2015 2016 2017 2018 2019 

EPs who have claims with Medicare (thousands) ........................................................... 570.3 576.0 581.7 587.5 593.3 599.0 

Non-Hospital Based EPs (thousands) ............................................................................. 492.2 497.1 502.1 507.1 512.0 517.0 

EPs that are both Medicare and Medicaid EPs (thousands) .......................................... 98.4 99.4 100.4 101.4 102.4 103.4 

Low Scenario: 

Percent of EPs who are Meaningful Users .............................................................. 18 21 24 28 32 36 

Meaningful Users (thousands) .................................................................................. 70.2 83.1 97.3 112.9 129.9 148.1 

High Scenario: 

Percent of EPs who are Meaningful Users .............................................................. 49 53 58 62 66 70 

Meaningful Users (thousands) .................................................................................. 192.6 212.2 231.9 251.3 270.4 288.8 

Our estimates of the incentive 

payment costs and payment adjustment 

savings are presented in Table 20. These 

costs 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 

certified EHR technology. 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 electronic health records (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 for the low 

scenario of the Medicare EP portion of 

the HITECH Act are shown in Table 20. 

TABLE 20—ESTIMATED COSTS (+) AND SAVINGS (–) FOR MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF

CERTIFIED EHR TECHNOLOGY, LOW SCENARIO

[In 2012 Billions] 

Fiscal year Incentive 

payments 

Payment 

adjustment 

receipts 

Benefit 

payments Net total 

2014 ................................................................................................................................. $0.6 .................... .................... $0.6 

2015 ................................................................................................................................. 0.5 ¥0.6 .................... ¥0.1 

2016 ................................................................................................................................. 0.3 ¥1.0 .................... ¥0.6 

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TABLE 20—ESTIMATED COSTS (+) AND SAVINGS (–) FOR MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF

CERTIFIED EHR TECHNOLOGY, LOW SCENARIO—Continued 

[In 2012 Billions] 

Fiscal year Incentive 

payments 

Payment 

adjustment 

receipts 

Benefit 

payments Net total 

2017 ................................................................................................................................. 0.1 ¥1.4 .................... ¥1.3 

2018 ................................................................................................................................. .................... ¥1.6 .................... ¥1.6 

2019 ................................................................................................................................. .................... ¥1.6 .................... ¥1.6 

Estimated net costs for the high 

scenario of the Medicare EP portion of 

the HITECH Act are shown in Table 21. 

TABLE 21—ESTIMATED COSTS (+) AND SAVINGS (–) FOR MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF

CERTIFIED EHR TECHNOLOGY, HIGH SCENARIO

[In 2012 Billions] 

Fiscal year Incentive 

Payments 

Payment 

Adjustment 

Receipts 

Benefit 

Payments Net Total 

2014 ................................................................................................................................. $1.3 .................... .................... $1.3 

2015 ................................................................................................................................. $1.1 ¥$0.4 .................... $0.7 

2016 ................................................................................................................................. $0.7 ¥$0.6 .................... $0.1 

2017 ................................................................................................................................. $0.3 ¥$0.8 .................... ¥$0.5 

2018 ................................................................................................................................. .................... ¥$0.8 .................... ¥$0.8 

2019 ................................................................................................................................. .................... ¥$0.8 .................... ¥$0.8 

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 would 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 admission 

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 2008 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 21 provides 

these proportions. 

TABLE 22—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 ................................ 176 19 440 48 293 32 909 23 

Small/Medium .................. 817 31 1,352 51 462 18 2,631 67 

Large (400+beds) ............. 216 54 163 41 18 5 397 10 

Total .......................... 1209 31 1955 50 773 20 3,937 100 

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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 would incur additional 

costs of at least 10 percent of their IT 

budgets. These costs were based on 

cross-sectional 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 2008 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 high scenario estimated net costs 

for section 4102 of the HITECH Act are 

shown in Table 23: Estimated costs (+) 

and savings (–) for eligible hospitals 

adopting certified EHRs. This provision 

is estimated to increase Medicare 

hospital expenditures by a net total of 

$5.4 billion during FYs 2014 through 

2019. 

TABLE 23—ESTIMATED COSTS (+) AND SAVINGS (¥) FOR MEDICARE ELIGIBLE HOSPITALS DEMONSTRATING MEANINGFUL

USE OF CERTIFIED EHR TECHNOLOGY, HIGH SCENARIO

[In 2012 billions] 

Fiscal year Incentive 

payments 

Payment 

adjustment 

receipts 

Benefit 

payments Net total 

2014 ................................................................................................................................. $1.9 .................... (1) $1.9 

2015 ................................................................................................................................. 2.1 ¥0.3 (1) 1.8 

2016 ................................................................................................................................. 1.3 ¥0.1 (1) 1.2 

2017 ................................................................................................................................. 0.5 ¥0.1 (1) 0.5 

2018 ................................................................................................................................. .................... (1) (1) (1) 

2019 ................................................................................................................................. .................... .................... (1) (1) 

1Savings of less than $50 million. 

We are also providing the estimates 

for a low scenario in Table 24. 

TABLE 24—ESTIMATED COSTS (+) AND SAVINGS (¥) FOR MEDICARE ELIGIBLE HOSPITALS DEMONSTRATING MEANINGFUL

USE OF CERTIFIED EHR TECHNOLOGY, LOW SCENARIO

[In 2012 billions] 

Fiscal year Incentive 

payments 

Payment 

adjustment 

receipts 

Benefit 

payments Net total 

2014 ................................................................................................................................. $1.2 .................... (1) $1.2 

2015 ................................................................................................................................. 1.4 ¥0.9 (1) 0.5 

2016 ................................................................................................................................. 1.2 ¥0.6 (1) 0.6 

2017 ................................................................................................................................. 0.6 ¥0.3 (1) 0.3 

2018 ................................................................................................................................. .................... ¥0.2 (1) ¥0.2 

2019 ................................................................................................................................. .................... ¥0.1 (1) ¥0.1 

1Savings of less than $50 million. 

Based on the comparison of Medicare 

incentive payments and 

implementation/operating costs for each 

eligible hospital (described previously), 

we made the assumptions shown in 

Tables 25 and 26, related to the 

prevalence of certified EHR technology 

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 25 

shows the scenario’s estimates: 

TABLE 25—ASSUMED PROPORTION OF ELIGIBLE HOSPITALS WITH CERTIFIED EHR TECHNOLOGY, BY PERCENTAGE OF

SYSTEM COST COVERED BY MEDICARE INCENTIVE PAYMENTS HIGH SCENARIO

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 .75 0 .6 

2015 ............................................................................. 1.0 1 .0 0 .95 0 .9 0 .8 

2016 ............................................................................. 1.0 1 .0 1 .0 0 .95 0 .9 

2017 ............................................................................. 1.0 1 .0 1 .0 1 .0 0 .95 

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TABLE 25—ASSUMED PROPORTION OF ELIGIBLE HOSPITALS WITH CERTIFIED EHR TECHNOLOGY, BY PERCENTAGE OF

SYSTEM COST COVERED BY MEDICARE INCENTIVE PAYMENTS HIGH SCENARIO—Continued 

Fiscal year 

Incentive payments as percentage of EHR technology cost 

100+% 75–100% 50–75% 25–50% 0–25% 

2018 ............................................................................. 1.0 1 .0 1 .0 1 .0 1 .0 

For instance, under the high scenario 

95 percent of eligible hospitals whose 

incentive payments would 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. 

Table 26 shows the low scenario 

estimates. 

TABLE 26—ASSUMED PROPORTION OF ELIGIBLE HOSPITALS WITH CERTIFIED EHR TECHNOLOGY, BY PERCENTAGE OF

SYSTEM COST COVERED BY MEDICARE INCENTIVE PAYMENTS LOW SCENARIO

Fiscal year 

Incentive payments as percentage of EHR technology cost 

100+% 75–100% 50–75% 25–50% 0–25% 

2014 ............................................................................. 0.9 0 .75 0 .55 0 .4 0 .3 

2015 ............................................................................. 1.0 0 .9 0 .75 0 .6 0 .5 

2016 ............................................................................. 1.0 1 .0 0 .9 0 .85 0 .75 

2017 ............................................................................. 1.0 1 .0 0 .95 0 .9 0 .85 

2018 ............................................................................. 1.0 1 .0 1 .0 0 .95 0 .9 

2019 ............................................................................. 1.0 1 .0 1 .0 1 .0 1 .0 

For large, organized facilities such as 

hospitals, we believe that the revenue 

losses caused by these payment 

adjustments would be a substantial 

incentive to adopt certified EHR 

technology, even in instances where the 

Medicare incentive payments would 

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 27, we estimated that the great 

majority of eligible hospitals would 

qualify for at least a portion of the 

Medicare incentive payments that they 

could potentially receive, and only a 

modest number would incur payment 

adjustments. Nearly all eligible 

hospitals are projected to have 

implemented certified EHR technology 

by FY 2019. Table 27 shows our high 

scenario 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 would 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, 

HIGH SCENARIO

Fiscal year 

Percent associated with eligible 

hospitals 

Percent payable in 

year 

2014 ............................................................................................................................................................. 82.6 82.6 

2015 ............................................................................................................................................................. 92.6 54.2 

2016 ............................................................................................................................................................. 96.9 43.4 

2017 ............................................................................................................................................................. 99.0 ..............................

2018 ............................................................................................................................................................. 100.0 ..............................

For instance in FY 2014 under the 

high scenario, 82.6 percent of the total 

amount of incentive payments which 

could be payable in that year would be 

for eligible hospitals who have 

demonstrated meaningful use of 

certified EHR technology and therefore 

will be paid. In FY 2015 under the high 

scenario, 92.6 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 would 

have already received 4 years of 

incentive payments, and therefore 54.2 

percent of all possible incentive 

payments actually paid in that year. 

Table 28 shows the low scenario 

estimates. 

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TABLE 28—ESTIMATED PERCENTAGE OF MEDICARE INCENTIVES WHICH COULD BE PAID FOR THE MEANINGFUL USE OF

CERTIFIED EHR TECHNOLOGY ASSOCIATED WITH ELIGIBLE HOSPITALS AND ESTIMATED PERCENTAGE PAYABLE IN

YEAR, LOW SCENARIO

Fiscal year 

Percent associated with eligible 

hospitals 

Percent payable in 

year 

2014 ............................................................................................................................................................. 47.6 47.6 

2015 ............................................................................................................................................................. 66.4 49.6 

2016 ............................................................................................................................................................. 85.9 64.1 

2017 ............................................................................................................................................................. 91.4 ..............................

2018 ............................................................................................................................................................. 95.6 ..............................

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 would 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) 

would also achieve meaningful use by 

2016. Current program payment data, as 

well as current data from the Regional 

Extension Centers, does not provide 

enough information for us to alter these 

estimates. Therefore, we are maintaining 

these estimates for the current impact 

analysis. Our estimates regarding the 

incentives that will be paid to CAHs are 

incorporated into the overall Medicare 

and Medicaid program costs. 

5. 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 proposed rule 43 States are already 

participating in the Medicaid incentive 

payment program and the remaining 

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 

29 shows our high estimates for the net 

Medicaid costs for eligible hospitals and 

EPs. 

TABLE 29—ESTIMATED FEDERAL COSTS (+) AND SAVINGS (¥) UNDER MEDICAID, HIGH SCENARIO

[In 2012 $billions] 

Fiscal year 

Incentive payments 

Benefit 

payments Net total 

Hospitals Eligible 

professionals 

2014 ................................................................................................................. 0.7 0.9 (1) 1.6 

2015 ................................................................................................................. 0.6 1.1 (1) 1.7 

2016 ................................................................................................................. 0.5 1.1 (1) 1.7 

2017 ................................................................................................................. 0.4 0.9 (1) 1.3 

2018 ................................................................................................................. 0.2 0.6 (1) 0.7 

2019 ................................................................................................................. 0.0 0.3 (1) 0.3 

1Savings of less than $50 million. 

Table 30 shows the low estimates for 

Medicaid costs and savings. 

TABLE 30—ESTIMATED FEDERAL COSTS (+) AND SAVINGS (¥) UNDER MEDICAID, LOW SCENARIO

[In 2012 $billions] 

Fiscal year 

Incentive payments 

Benefit 

payments Net total 

Hospitals Eligible 

professionals 

2014 ................................................................................................................. 0.4 0.4 (1) 0.8 

2015 ................................................................................................................. 0.5 0.5 (1) 1.0 

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TABLE 30—ESTIMATED FEDERAL COSTS (+) AND SAVINGS (¥) UNDER MEDICAID, LOW SCENARIO—Continued 

[In 2012 $billions] 

Fiscal year 

Incentive payments 

Benefit 

payments Net total 

Hospitals Eligible 

professionals 

2016 ................................................................................................................. 0.7 0.6 (1) 1.3 

2017 ................................................................................................................. 0.8 0.5 (1) 1.3 

2018 ................................................................................................................. 0.4 0.4 (1) 0.9 

2019 ................................................................................................................. 0.1 0.3 (1) 0.4 

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 non-hospital-based 

Medicare EPs would 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 high scenario estimates are listed in 

Table 31. 

TABLE 31—ASSUMED NUMBER OF NONHOSPITAL BASED MEDICAID EPS WHO WILL BE MEANINGFUL USERS OF

CERTIFIED EHR TECHNOLOGY, HIGH SCENARIO

[All population figures are in thousands] 

Calendar year 

2014 2015 2016 2017 2018 2019 

EPs who have claims with Medicare .......................................... 570.3 576.0 581.7 587.5 593.3 599.0 

Non Hospital-Based EPs ............................................................ 492.2 497.1 502.1 507.1 512.0 517.0 

A EPs who meet the Medicaid patient volume threshold .............. 98.4 99.4 100.4 101.4 102.4 103.4 

B Medicaid 1 only EPs .................................................................... 46.3 47.1 47.8 48.6 49.3 50.1 

Total Medicaid EPs (A + B) ........................................................ 144.7 146.5 148.2 150.0 151.7 153.5 

Percent of EPs receiving incentive payment during year .......... 82.2% 85.6% 88.8% 43.8% 25.0% 14.4% 

Number of EPs receiving incentive payment during year .......... 119.0 125.4 131.7 65.7 38.0 22.1 

Percent of EPs who have ever received incentive payment ...... 82.2% 85.6% 88.8% 91.9% 94.7% 95.9% 

Number of EPs who have ever received incentive payment ..... 119.0 125.4 131.7 137.7 143.6 147.2 

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 

certified EHR technology as well. Table 

32 shows our low scenario estimates. 

TABLE 32—ASSUMED NUMBER OF NONHOSPITAL BASED MEDICAID EPS WHO WILL BE MEANINGFUL USERS OF

CERTIFIED EHR TECHNOLOGY LOW SCENARIO

[All population figures are in thousands] 

Calendar year 

2014 2015 2016 2017 2018 2019 

EPs who have claims with Medicare .......................................... 570.3 576.0 581.7 587.5 593.3 599.0 

Non Hospital-Based EPs ............................................................ 492.2 497.1 502.1 507.1 512.0 517.0 

A EPs who meet the Medicaid patient volume threshold .............. 98.4 99.4 100.4 101.4 102.4 103.4 

B Medicaid 1 only EPs .................................................................... 46.3 47.1 47.8 48.6 49.3 50.1 

Total Medicaid EPs (A + B) ........................................................ 144.7 146.5 148.2 150.0 151.7 153.5 

Percent of EPs receiving incentive payment during year .......... 36.0% 40.5% 45.3% 30.7% 21.9% 15.1% 

Number of EPs receiving incentive payment during year .......... 52.1 59.4 67.2 46.0 33.2 23.1 

Percent of EPs who have ever received incentive payment ...... 36.0% 40.5% 45.3% 50.4% 55.7% 59.9% 

Number of EPs who have received ever incentive payment ..... 52.1 59.4 67.2 75.5 84.4 91.9 

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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 33. 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 certified EHR 

technology are discussed under ‘‘general 

considerations.’’ Since we were using 

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 non-children’s hospitals. 

TABLE 33—ESTIMATED PERCENTAGE OF POTENTIAL MEDICAID INCENTIVES ASSOCIATED WITH ELIGIBLE HOSPITALS AND

ESTIMATED PERCENTAGE PAYABLE EACH YEAR, HIGH SCENARIO

Fiscal year 

Percent associated with eligible 

hospitals 

Percent payable in 

year 

2014 ............................................................................................................................................................. 83.1 44.0 

2015 ............................................................................................................................................................. 92.9 38.5 

2016 ............................................................................................................................................................. 97.1 26.2 

2017 ............................................................................................................................................................. 99.0 14.0 

2018 ............................................................................................................................................................. 100.0 4.2 

2019 ............................................................................................................................................................. 100.0 0.0 

Table 34 shows our low scenario 

estimates. 

TABLE 34—ESTIMATED PERCENTAGE OF POTENTIAL MEDICAID INCENTIVES ASSOCIATED WITH ELIGIBLE HOSPITALS AND

ESTIMATED PERCENTAGE PAYABLE EACH YEAR, LOW SCENARIO

Fiscal year 

Percent associated with eligible 

hospitals 

Percent payable in 

year 

2014 ............................................................................................................................................................. 49.2 30.9 

2015 ............................................................................................................................................................. 67.8 44.5 

2016 ............................................................................................................................................................. 86.5 52.8 

2017 ............................................................................................................................................................. 91.8 37.3 

2018 ............................................................................................................................................................. 95.9 18.7 

2019 ............................................................................................................................................................. 100.0 0.0 

6. Benefits for All EPs and All Eligible 

Hospitals 

In this proposed 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 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 four 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 

proposed 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 

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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. 

7. 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 would 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 proposed 

regulation 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. 

8. 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 

certified EHR technology 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 

certified EHR technology in the early 

years of the Medicare EHR incentive 

program. We expect that a steadily 

growing proportion of practices will 

implement certified EHR technology 

over the next 10 years, even in the 

absence of the Medicare incentives. 

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 certified EHR 

technology 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 would 

achieve these efficiencies sooner than 

would otherwise occur, without the 

EHR incentives. 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. 

9. Summary 

Consistent with the estimates we are 

maintaining from the Stage 1 final rule, 

the total cost to the Medicare and 

Medicaid programs between 2014 and 

2019 is estimated to be $3.3 billion in 

transfers under the low scenario, and 

$12.7 billion under the high scenario. 

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. 

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TABLE 35—ESTIMATED EHR INCENTIVE PAYMENTS AND BENEFITS IMPACTS ON THE MEDICARE AND MEDICAID PROGRAMS

OF THE HITECH EHR INCENTIVE PROGRAM (FISCAL YEAR)—(IN 2012 BILLIONS) LOW SCENARIO

Fiscal year 

Medicare eligible Medicaid eligible 

Total 

Hospitals Professionals Hospitals Professionals 

2014 ..................................................................................... $1.2 $0.6 $0.4 $0.4 $2.6 

2015 ..................................................................................... 0.5 ¥0.1 0.5 0.5 1.4 

2016 ..................................................................................... 0.6 ¥0.6 0.7 0.6 1.3 

2017 ..................................................................................... 0.3 ¥1.3 0.8 0.5 0.3 

2018 ..................................................................................... ¥0.2 ¥1.6 0.4 0.4 ¥1.0 

2019 ..................................................................................... ¥0.1 ¥1.6 0.1 0.3 ¥1.3 

Table 36 shows the total costs from 

2014 through 2019 for the high scenario. 

TABLE 36—ESTIMATED EHR INCENTIVE PAYMENTS AND BENEFITS IMPACTS ON THE MEDICARE AND MEDICAID PROGRAMS

OF THE HITECH EHR INCENTIVE PROGRAM (FISCAL YEAR)—(IN 2012 BILLIONS) HIGH SCENARIO

Fiscal year 

Medicare eligible Medicaid eligible 

Total 

Hospitals Professionals Hospitals Professionals 

2014 ..................................................................................... $1.9 $1.3 $0.7 $0.9 $4.8 

2015 ..................................................................................... 1.8 0.7 0.6 1.1 4.2 

2016 ..................................................................................... 1.2 0.1 0.5 1.1 2.9 

2017 ..................................................................................... 0.5 ¥0.5 0.4 0.9 1.3 

2018 ..................................................................................... ........................ ¥0.8 0.2 0.6 0.0 

2019 ..................................................................................... ........................ ¥0.8 ........................ 0.3 ¥0.5 

10. Explanation of Benefits and Savings 

Calculations 

In our analysis, we assume that 

benefits to the program would accrue in 

the form of savings to Medicare, through 

the Medicare EP 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 

proposed 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 proposed rule. 

Expected qualitative benefits include 

improved quality of care, better health 

outcomes, reduced errors and the like. 

Private industry costs would 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. 

TABLE 37—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES CYS 2014 THROUGH 2019 

[In 2012 millions] 

Category Benefits 

Qualitative ......................................................................................................... Expected qualitative benefits include improved quality of care, 

better health outcomes, reduced errors and the like. 

Costs 

Year Estimates Unit Period 

dollar (in millions) discount covered 

rate 

Low High 

estimate estimate 

Annualized Monetized Costs to Private Industry Associated with Reporting 

Requirements.

2012 $186.5 $191.8 7% CYs 2014–2019 

$186.5 $191.8 3% 

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Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 13813 

TABLE 37—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES CYS 2014 THROUGH 2019— 

Continued 

[In 2012 millions] 

Qualitative—Other private industry costs associated with the adoption of 

EHR technology.

These costs would 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 Estimates Unit Period 

dollar (in millions) discount covered 

rate 

Low High 

estimate estimate 

Federal Annualized Monetized ......................................................................... 2012 $705.7 $2,345.6 7% CYs 2014–2019 

$618.2 $2,216.9 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 would 

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 object of the 

Regulatory Flexibility Analysis to 

minimize burden on small entities are 

met by this proposed rule. We invite 

public comments on the analysis and 

request any additional data that would 

help us determine more accurately the 

impact on the EPs and eligible hospitals 

affected by the proposed 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 proposes to amend 

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 

(d)(5). 

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 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 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). Such exceptions are 

subject to annual renewal, but in no 

case may a hospital be granted such an 

exception for more than 5 years. (See 

§ 495.4 for definitions of payment 

adjustment year, EHR reporting period, 

and meaningful EHR user.) 

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13814 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 

(A) During the fiscal year that is 2 

years 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 no 

later than April 1 of the year before the 

applicable payment adjustment year. 

(B) During either of the 2 fiscal years 

before the payment adjustment year, the 

hospital faces extreme and 

uncontrollable circumstances that 

prevent it from becoming a meaningful 

EHR user. Applications requesting this 

exception must be submitted no later 

than 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 as a 

new hospital. 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 has been in 

operation for more than 2 years but has 

participated in the Medicare program 

for less than 2 years. 

(4) A hospital that changes its status 

from a CAH to a hospital that is subject 

to the capital prospective payment 

systems. 

(5) A State in which hospitals are paid 

for services under section 1814(b)(3) of 

the Act must 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. 

Such a State must 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. 

* * * * * 

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) for the applicable payment 

adjustment year no later than 60 days 

after the close of the applicable EHR 

reporting period. The Secretary may 

grant an exception for one or more than 

one of the following: 

(A) A CAH that is 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. 

(C) A new CAH, which, for the 

purposes of this exception, means a 

CAH that has operated (under previous 

or present ownership) for less than 1 

year. 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 as a new CAH. 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 in operation 

for more than 1 year but has 

participated in the Medicare program 

for less than 1 year. 

(4) 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,’’ and paragraphs (1) 

and (3) of the definition of ‘‘Meaningful 

EHR user’’. 

D. Adding the definition of ‘‘Payment 

adjustment year’’ in alphabetical order. 

The additions and revisions 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 

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meaningful EHR user, any continuous 

90-day period within the calendar year; 

(ii) 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. 

(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) 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. 

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) Except as provided in paragraphs 

(1)(ii) and (iii) of this definition, the 

calendar year that is 2 years before the 

payment adjustment year. 

(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) Except as provided in paragraphs 

(2)(ii) and (iii) of this definition, the 

Federal fiscal year that is 2 years before 

the payment adjustment year. 

(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 is an EP (as defined 

under this section) who furnishes 90 

percent or more of his or her covered 

professional services in a hospital 

setting in the year preceding the 

payment year, or in the year 2 years 

before the payment adjustment year. For 

Medicare, this will be calculated based 

on the Federal FY before the payment 

year for purposes of determining 

qualification for incentive payments, or 

2 years before the or payment 

adjustment year for purposes of 

determining whether a payment 

adjustment applies. For Medicaid, it is 

at the State’s discretion if the data is 

gathered on the Federal FY or CY before 

the payment year. A setting is 

considered a hospital setting if it is a 

site of service that would be identified 

by the codes used in the HIPAA 

standard transactions as an inpatient 

hospital, or emergency room setting. 

* * * * * 

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 

during an applicable EHR reporting 

period for a 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 495.6 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. Redesignating paragraph (d)(1)(ii) 

as paragraph (d)(1)(ii)(A). 

F. Adding paragraphs (d)(1)(ii)(B) and 

(C). 

G. Redesignating paragraph (d)(8)(i)(E) 

as paragraph (d)(8)(i)(E)(1). 

H. Adding a paragraph (d)(8)(i)(E)(2). 

I. Redesignating paragraph (d)(8)(ii) as 

paragraph (d)(8)(ii)(A). 

J. Adding paragraphs (d)(8)(ii)(B) and 

(C). 

K. Redesignating paragraph (d)(8)(iii) 

as paragraph (d)(8)(iii)(A). 

L. Adding paragraphs (d)(8)(iii)(B) 

and (C). 

M. Redesignating paragraph (d)(10)(i) 

as paragraph (d)(10)(i)(A). 

N. Adding paragraph (d)(10)(i)(B). 

O. Redesignating paragraph (d)(10)(ii) 

as paragraph (d)(10)(ii)(A). 

P. Adding a paragraph (d)(10)(ii)(B). 

Q. Redesignating paragraph (d)(12)(i) 

as paragraph (d)(12)(i)(A). 

R. Adding a paragraph (d)(12)(i)(B). 

S. Redesignating paragraph (d)(12)(ii) 

as paragraph (d)(12)(ii)(A). 

T. Adding a paragraph (d)(12)(ii)(B). 

U. Redesignating paragraph (d)(12)(iii) 

as paragraph (d)(12)(iii)(A). 

V. Adding a paragraph (d)(12)(iii)(B). 

W. Redesignating paragraph (d)(14)(i) 

as paragraph (d)(14)(i)(A). 

X. Adding a paragraph (d)(14)(i)(B). 

Y. Redesignating paragraph (d)(14)(ii) 

as paragraph (d)(14)(ii)(A). 

Z. Adding a paragraph (d)(14)(ii)(B). 

AA. In paragraph (e) introductory 

text— 

(i) Removing the ‘‘:’’ and adding a ‘‘.’’ 

in its place. 

(ii) Adding a sentence at the end of 

the paragraph. 

BB. Redesignating paragraph (e)(5)(i) 

as paragraph (e)(5)(i)(A). 

CC. Adding a paragraph (e)(5)(i)(B). 

DD. Redesignating paragraph (e)(5)(ii) 

as paragraph (e)(5)(ii)(A). 

EE. Adding paragraph (e)(5)(ii)(B). 

FF. Redesignating paragraph (e)(9)(i) 

as (e)(9)(i)(A). 

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GG. Adding paragraph (e)(9)(i)(B). 

HH. Redesignating paragraph (e)(10)(i) 

as (e)(10)(i)(A). 

II. Adding paragraph (e)(10)(i)(B). 

JJ. Redesignating paragraph (f)(1)(ii) as 

paragraph (f)(1)(ii)(A). 

KK. Adding paragraphs (f)(1)(ii)(B) 

and (C). 

LL. Redesignating paragraph 

(f)(7)(i)(E) as paragraph (f)(7)(i)(E)(1). 

MM. Adding a paragraph 

(f)(7)(i)(E)(2). 

NN. Redesignating paragraph (f)(7)(ii) 

as (f)(7)(ii)(A). 

OO. Adding paragraphs (f)(7)(ii)(B) 

and (C). 

PP. Redesignating paragraph (f)(9)(i) 

as paragraph (f)(9)(i)(A). 

QQ. Adding a paragraph (f)(9)(i)(B). 

RR. Redesignating paragraph (f)(9)(ii) 

as paragraph (f)(9)(ii)(A). 

SS. Adding a paragraph (f)(9)(ii)(B). 

TT. Redesignating paragraph (f)(12)(i) 

as paragraph (f)(12)(i)(A). 

UU. Adding a paragraph (f)(12)(i)(B). 

VV. Redesignating paragraph 

(f)(12)(ii) as paragraph (f)(12)(ii)(A). 

WW. Adding a paragraph (f)(12)(ii)(B). 

XX. Redesignating paragraph (f)(13)(i) 

as paragraph (f)(13)(i)(A). 

YY. Adding a paragraph (f)(13)(i)(B). 

ZZ. Redesignating paragraph (f)(13)(ii) 

as paragraph (f)(13)(ii)(A). 

AAA. Adding a paragraph 

(f)(13)(ii)(B). 

BBB. In paragraph (g) introductory 

text— 

(i) Removing the ‘‘:’’ and adding a ‘‘.’’ 

in its place. 

(ii) Adding a sentence at the end of 

the paragraph. 

CCC. Redesignating paragraph (g)(8)(i) 

as paragraph (g)(8)(i)(A). 

DDD. Adding a paragraph (g)(8)(i)(B). 

EEE. Redesignating paragraph (g)(9)(i) 

as paragraph (g)(9)(i)(A). 

FFF. Adding a paragraph (g)(9)(i)(B). 

GGG Redesignating paragraph 

(g)(10)(i) as paragraph (g)(10)(i)(A). 

HHH. Adding a paragraph 

(g)(10)(i)(B). 

III. Revising paragraphs (h) and (i). 

JJJ. 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 in 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 exclusions apply. 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 

(e)(10) of this section, unless the EP 

meets five or more exclusions specified 

in paragraph (e) of this section, in which 

case the EP must meet all remaining 

objectives and associated measures. 

* * * * * 

(b) * * * 

(2) * * * 

(ii) * * * 

(B) Beginning in 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), (g)(9), or (g)(10) of this 

section. 

(d) * * * 

(1) * * * 

(ii) * * * 

(B) For 2013, 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 CPOE or the measure 

specified in paragraph (d)(1)(ii)(A) of 

this section. 

(C) Beginning 2014, only the measure 

specified in paragraph (d)(1)(ii)(B) of 

this section. 

* * * * * 

(8)(i) * * * 

(E) * * * 

(2) For 2013, plot and display growth 

charts for patients 0–20 years, including 

BMI. 

(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) of 

this section. 

(iii) * * * 

(B) For 2013, 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/length, weight, and blood 

pressure have no relevance to their 

scope of practice is excluded from 

recording them; 

(3) 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 

(4) 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 exclusion in 

paragraph (d)(8)(iii)(B) 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 in 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. 

* * * * * 

(e) * * *. Beginning in 2014, an EP 

must meet five of the following 

objectives and associated measures, one 

of which must be either paragraph (e)(9) 

or (e)(10) of this section unless the EP 

meets five or more exclusions specified 

in this paragraph (e), in which case the 

EP must meet all remaining objectives 

and associated measures: 

* * * * * 

(5)(i) * * * 

(B) Beginning 2014, this objective is 

no longer included in the menu set. 

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(ii) * * * 

(B) Beginning 2014, this measure is no 

longer included in the menu set. 

* * * * * 

(9)(i) * * * 

(B) Beginning in 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 in 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) Beginning 2013, 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 

CPOE, or the measure specified in 

paragraph (f)(1)(ii)(A) of this section. 

(C) Beginning 2014, only the measure 

specified in paragraph (f)(1)(ii)(B) of this 

section. 

* * * * * 

(7) * * * 

(i) * * * 

(E) * * * 

(2) Beginning 2013, plot and display 

growth charts for patients 0–20 years, 

including BMI. 

(ii) * * * 

(B) For 2013, 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) are recorded as structured 

data. 

(C) Beginning 2014, only the measure 

specified in paragraph (f)(7)(ii)(B) 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 (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 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. 

* * * * * 

(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 in 2014, eligible 

hospitals or CAHs must meet five of the 

following objectives and associated 

measures, one which must be specified 

in paragraph (g)(8), (g)(9), or (g)(10) of 

this section: 

* * * * * 

(8)(i) * * * 

(B) Beginning in 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 in 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 in 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 

paragraphs (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 4 or more exclusions 

apply. For example, an EP that has an 

exclusion for 1 of the objectives in 

paragraph (k) of this section must meet 

3 of the 4 nonexcluded objectives from 

such paragraph to meet the definition of 

a meaningful EHR user. If an EP has an 

exclusion for 4 of the objectives in 

paragraph (k) of this section, then he or 

she must meet the remaining the 

nonexcluded objective 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 two 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 

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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 unless 3 or more exclusions 

apply. For example, an eligible hospital 

that has an exclusion for 1 of the 

objectives in paragraph (m) of this 

section must meet 2 of the 3 nonexcluded objectives from such 

paragraph to meet the definition of a 

meaningful EHR user. If an eligible 

hospital has an exclusion for 3 of the 

objectives in paragraph (m) of this 

section, then the hospital must meet the 

remaining nonexcluded objective 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 (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. 

(ii) Measure. More than 60 percent of 

medication, laboratory, and radiology 

orders created by the EP during the EHR 

reporting period are recorded using 

CPOE. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who writes fewer than 100 medication, 

laboratory, and radiology orders during 

the EHR reporting period. 

(2)(i) Objective. Generate and transmit 

permissible prescriptions electronically 

(eRx). 

(ii) 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 Certified EHR Technology. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who writes fewer than 100 prescriptions 

during the EHR reporting period or does 

not have a pharmacy within their 

organization and there are no 

pharmacies that accept electronic 

prescriptions within 25 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) Gender. 

(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 BMI. 

(ii) Measure. 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. 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 five or more clinical quality 

measures, if applicable, at a relevant 

point in patient care for the entire EHR 

reporting period; and 

(B) The EP has enabled the 

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

EHR reporting period. 

(7)(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 

the EP during the EHR reporting period 

whose results are either in a positive/ 

negative 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 or 

numeric 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. 

(ii) Measure. More than 10 percent of 

all unique patients who have had an 

office visit with the EP within the 24 

months before the beginning of the EHR 

reporting period were sent a reminder, 

per patient preference. 

(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 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. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who neither orders nor creates any of 

the information listed for inclusion as 

part of this measure is excluded from 

both paragraphs (i)(10)(ii)(A) and (B) of 

this section Any EP that conducts the 

majority (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 

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availability according to the latest 

information available from the FCC on 

the first day of the EHR reporting period 

is excluded from paragraph (i)(10)(ii)(B) 

of this section. 

(11)(i) Objective. Provide clinical 

summaries for patients for each office 

visit. 

(ii) Measure. Clinical summaries 

provided to patients within 24 hours 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 office visits by the EP. 

(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. The EP performs 

medication reconciliation for more than 

65 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 should provide summary care 

record for each transition of care or 

referral. 

(ii) Measures. (A) 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 65 percent of transitions 

of care and referrals; and 

(B) The EP that transitions or refers 

their patient to another setting of care or 

provider of care electronically transmits 

using Certified EHR Technology to a 

recipient with no organizational 

affiliation and using a different Certified 

EHR Technology vendor than the sender 

a summary of care record for more than 

10 percent of transitions of care and 

referrals. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who neither transfers a patient to 

another setting nor refers a patient to 

another provider during the EHR 

reporting period is excluded from both 

measures. 

(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) The EP does not administer any of 

the immunizations to any of the 

populations for which data is collected 

by the jurisdiction’s immunization 

registry or immunization information 

system during the EHR reporting period. 

(B) The EP 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 Certified EHR 

Technology at the start of their EHR 

reporting period. 

(C) The EP 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’s Certified EHR 

Technology can send at the start of their 

EHR reporting period. 

(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 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 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 10 percent of unique 

patients 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. 

(k) Stage 2 menu set criteria for EPs. 

An EP must meet 3 of the following 

objectives and associated measures, 

unless the EP meets 4 or more 

exclusions specified in this paragraph 

(k), in which case the EP must meet all 

remaining objectives and associated 

measures. 

(1)(i) Objective. Imaging results and 

information are accessible through 

Certified EHR Technology. 

(ii) Measure. More than 40 percent of 

all scans and 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 does not perform diagnostic 

interpretation of scans or tests whose 

result is an image during 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) The EP is not in a category of 

providers who collect ambulatory 

syndromic surveillance information on 

their patients during the EHR reporting 

period. 

(B) The EP 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) The EP operates in a jurisdiction 

for which no public health agency is 

capable of accepting the version of the 

standard that the EP’s Certified EHR 

Technology can send at the start of their 

EHR reporting period. 

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(4)(i) Objective. Capability to identify 

and report cancer cases to a State 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 

cancer registry for the entire EHR 

reporting period. 

(iii) Exclusion in accordance with 

paragraph (h)(2) of this section. Any EP 

who— 

(A) Does not diagnose or directly treat 

cancer; or 

(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. 

(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— 

(A) Does not diagnose or directly treat 

any disease associated with a 

specialized registry; or 

(B) Operates in a jurisdiction for 

which no registry is capable of receiving 

electronic specific case information in 

the specific standards required under 

Stage 2 at the beginning of their EHR 

reporting period. 

(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 (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. 

(ii) Measure. More than 60 percent of 

medication, laboratory, and 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 CPOE. 

(2)(i) Objective. Record all of the 

following demographics: 

(A) Preferred language. 

(B) Gender. 

(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 BMI. 

(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 

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. 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 five or more clinical quality 

measures, if applicable, at a relevant 

point in patient care for the entire EHR 

reporting period; and 

(B) The eligible hospital or CAH has 

enabled the functionality for drug-drug 

and drug-allergy interaction checks for 

the duration of the 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 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 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. 

(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 4Mbps broadband availability 

according to the latest information 

available from the FCC at the start 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. The eligible hospital or 

CAH performs medication 

reconciliation for more than 65 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). 

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(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 should provide 

summary care record for each transition 

of care or referral. 

(ii) Measures. (A) 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 65 percent of 

transitions of care and referrals; and 

(B) The eligible hospital or CAH that 

transitions or refers their patient to 

another setting of care or provider of 

care electronically transmits using 

Certified EHR Technology to a recipient 

with no organizational affiliation and 

using a different Certified EHR 

Technology vendor than the sender a 

summary of care record for more than 

10 percent of transitions of care and 

referrals. 

(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 the 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 

receiving electronic immunization data 

in the specific standards required for 

Certified EHR Technology at the start of 

their EHR reporting period. 

(C) The eligible hospital or CAH does 

not have an immunization registry or 

immunization information system 

capable of accepting the version of the 

standard that the eligible hospital’s or 

CAH’s Certified EHR Technology can 

send at the start of their EHR reporting 

period. 

(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 as 

authorized, and in accordance with 

applicable State law and practice. 

(iii) Exclusion in accordance with 

paragraph (i)(2) of this section. Any 

eligible hospital or CAH that 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. 

(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) The eligible hospital or CAH does 

not have an emergency or urgent care 

department. 

(B) The 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. 

(C) The eligible hospital or CAH 

operates in a jurisdiction for which no 

public health agency is capable of 

accepting the version of standard that 

the eligible hospital’s or CAH’s Certified 

EHR Technology can send at the start of 

their EHR reporting period. 

(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 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 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. eMAR is implemented 

and in use for the entire EHR reporting 

period in at least one ward/unit of the 

hospital. 

(m) Stage 2 menu set criteria for 

eligible hospitals or CAHs. An eligible 

hospital or CAH must meet the measure 

criteria for two 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. 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. 

(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. 

(2)(i) Objective. Imaging results and 

information are accessible through 

Certified EHR Technology. 

(ii) Measure. More than 40 percent of 

all scans and 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 or 

changed prescriptions) are compared 

against at least one 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 25 miles. 

8. Section 495.8 is amended as 

follows: 

A. Revising paragraph (a)(2)(i)(B) and 

(a)(2)(ii). 

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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. 

* * * * * 

9. 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 (d)(1), 

(d)(2)(iii), and (d)(3). 

B. Adding paragraphs (d)(2)(iv), (d)(4), 

and (d)(5). 

The revisions and additions read as 

follows: 

§ 495.102 Incentive payments to EPs. 

* * * * * 

(d) Payment adjustment effective in 

CY 2015 and subsequent years for 

nonqualifying EPs. (1)(i) Subject to 

paragraphs (d)(3) and (d)(4) of this 

section, beginning in 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 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 

with 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 

demonstrating that it meets one or more 

of the criteria in this paragraph (d)(4). 

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 the calendar year that is 2 

years before the payment adjustment 

year, the EP was located in an area 

without sufficient Internet access to 

comply with the meaningful EHR 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) During either of the 2 calendar 

years before the payment adjustment 

year, the EP 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. 

(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] 

11. 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. 

12. Section 495.200 is amended by— 

A. Adding definitions for ‘‘Adverse 

eligibility determination,’’ ‘‘Adverse 

payment determination,’’ ‘‘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. 

Adverse eligibility determination 

means a determination or omission by 

CMS that was the result of a 

malfunction of a CMS system that 

prohibits a qualifying MA organization, 

qualifying MA EP, or qualifying MAaffiliated eligible hospital from 

participating in the Medicare Advantage 

EHR Incentive Program. 

Adverse payment determination 

means a determination by CMS that 

negatively affects an EHR payment 

determination under this subpart. 

* * * * * 

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 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 

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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. 

* * * * * 

13. 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 

‘‘(b)(4)’’ in its place. 

C. In paragraph (b)(2)(iii), removing 

the term ‘‘NPI.’’ and adding the phrase 

‘‘NPI or CCN.’’ in its place. 

D. Redesignating paragraphs (b)(3) 

and (b)(4) as paragraphs (b)(4) and 

(b)(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. 

* * * * * 

(3) When reporting under either 

paragraph (b)(1) or (b)(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; 

(ii) Include information specified in 

paragraph (b)(2)(i) through (iii) of this 

section for each professional or hospital; 

and 

* * * * * 

14. Section 495.204 is amended as 

follows: 

A. Revising the section heading. 

B. Revising paragraphs (b)(2) and 

(b)(4). 

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. 

15. 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. 

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(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. 

* * * * * 

16. 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. 

17. A new § 495.211 is added 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. 

(d) Payment adjustments effective for 

2015 and subsequent years with respect 

to MA EPs. (1) For payment adjustment 

year 2015, and subsequent payment 

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. 

18. A new § 495.213 is added to 

subpart C to read as follows: 

§ 495.213 Reconsideration process for a 

qualifying MA organization. 

(a) In general. A qualifying MA 

organization may seek reconsideration 

of an adverse eligibility or payment 

determination in accordance with the 

requirements of this section. 

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(b) Rejection of requests barred from 

administrative and judicial review. 

Reconsideration requests prohibited 

under § 495.212 will be rejected. 

(c) Rejection of requests including 

new payment information. 

Reconsideration requests that seek to 

include new payment-related 

information will be rejected. 

(d) Channeling of hospital and 

meaningful use reconsideration 

requests. (1) All reconsideration 

requests involving MA-affiliated eligible 

hospitals must meet the requirements of 

and be channeled through the 

reconsideration process in subpart E of 

this part and will be rejected for 

reconsideration under this section. 

(2) All reconsideration requests 

involving the meaningful use of 

Certified EHR Technology must follow 

the requirements of and be channeled 

through the reconsideration process in 

subpart E of this part and will be 

rejected for reconsideration under this 

section. 

(e) Informal reconsideration. (1)(i) A 

qualifying MA organization must 

request an informal reconsideration in 

writing within 60 calendar days of an 

adverse eligibility or payment 

determination. 

(ii) If the 60th calendar day occurs on 

a Saturday, Sunday or Federal holiday, 

the request for an informal 

reconsideration is due the calendar day 

following the Sunday or Federal 

holiday. 

(2) The request for an informal 

reconsideration—(i) Must specify the 

finding(s) or issue(s) with which the 

qualifying MA organization disagrees 

and the reason(s) for the disagreement; 

and 

(ii) May include additional 

documentary evidence that the 

qualifying MA organization wishes CMS 

to consider. 

(3) An informal reconsideration 

decision is final and binding, absent 

reopening due to audit or other 

evidence of material misrepresentation, 

unless a request for a final 

reconsideration is requested in 

accordance with paragraph (f) of this 

section. 

(f) Final reconsideration. (1)(i) A 

qualifying MA organization seeking a 

final reconsideration must request the 

final reconsideration in writing within 

30 calendar days of the date on the 

notice issued as a result of the informal 

reconsideration. 

(ii) If the 30th calendar day occurs on 

a Saturday, Sunday or Federal holiday, 

the request for a final reconsideration is 

due the calendar day following the 

Sunday or Federal holiday. 

(2) The request for a final 

reconsideration must— 

(i) Specify the finding(s) or issue(s) 

with which the qualifying MA 

organization disagrees and the reason(s) 

for the disagreement; 

(ii) Include a copy of the documents 

and evidence submitted for the informal 

reconsideration and a copy of the 

decision issued in accordance with the 

informal reconsideration. 

(iii) Not include new evidence or 

documents not presented at the informal 

reconsideration level. 

(3) A final reconsideration is final and 

binding, absent reopening due to audit 

or other evidence of material 

misrepresentation. 

19. Section 495.302 is amended as 

follows: 

A. In the definition of ‘‘Children’s 

hospital,’’ by revising paragraph (1), 

redesignating paragraph (2) as paragraph 

(3), and adding a new paragraph (2). 

B. In the definition of ‘‘Practices 

predominantly,’’ by removing the 

phrase ‘‘in the most recent calendar year 

occurs’’ and adding the phrase ‘‘(within 

the most recent calendar year or within 

the 12-month period preceding 

attestation)’’. 

The revision and addition reads as 

follows: 

§ 495.302 Definitions. 

* * * * * 

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 (c)(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. 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 ‘‘.’’ 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 ‘‘.’’ in its 

place. 

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 ‘‘.’’ 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 ‘‘; ’’ and adding ‘‘.’’ in its 

place. 

L. In paragraph (e)(3)(iii), by removing 

‘‘; or’’ and adding ‘‘.’’ 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 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, 

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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 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 per 

inpatient discharge 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 

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 

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 

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 

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 the second sentence of 

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. 

(a) * * * 

(1) * * * 

(ii) [Reserved]. 

(2) * * * 

(ii) [Reserved]. 

* * * * * 

(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) * * * 

(B) * * *. The discharge-related 

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 495.332 is amended as 

follows: 

A. Adding a new paragraph (b)(6). 

B. Revising paragraph (c) introductory 

text. 

C. Removing paragraph (d)(9). 

D. Adding a new paragraph (g). 

The revisions and additions 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) Subject to paragraph (g) of this 

section, for monitoring and validation of 

information States must include the 

following: 

* * * * * 

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(g) 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. 

25. 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 a minimum of 12 

months from the date of the last CMS 

approved HIT IAPD and must contain 

the following: 

* * * * * 

26. Section 495.370 is amended by 

adding a new 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. 

27. Add a new subpart E to read as 

follows: 

Subpart E—Administrative Review of 

Certain Electronic Health Record Incentive 

Program Determinations 

Sec. 

495.400 Basis and purpose. 

495.402 Definitions. 

495.404 Provider scope and eligibility to 

file. 

495.406 Filing appeals. 

495.408 General filing rules. 

495.410 Other requirements. 

495.412 Informal review process and 

decision. 

495.414 Final reconsiderations. 

Subpart E—Administrative Review of 

Certain Electronic Health Record 

Incentive Program Determinations 

§ 495.400 Basis and purpose. 

This subpart— 

(a) Contains an administrative appeal 

process for Medicare EPs, eligible 

hospitals, and CAHs, and, in certain 

cases, Medicaid eligible hospitals and 

potentially qualifying MA EPs and MAaffiliated eligible hospitals; and 

(b) Defines the types of appeals and 

issues that may be raised on appeal as 

well as the documents or data, or both, 

that must be submitted to support issues 

raised in the appeal filing. 

§ 495.402 Definitions. 

For purposes of this subpart, the 

following definitions apply: 

Circumstance outside a provider’s 

control means any event that reasonably 

prevented a provider from participating 

in the EHR Incentive Program and 

which the provider could not under any 

circumstances control. 

Eligibility appeal means any of the 

following: 

(1) An appeal filed by a provider that 

can demonstrate it met all program 

requirements for the EHR Incentive 

Program and should have received a 

payment but could not because of 

circumstances outside a provider’s 

control. A provider must also 

demonstrate an action to participate in 

the EHR Incentive Program. 

(2) An appeal of whether a hospital 

may be considered a potentially 

qualifying MA-affiliated eligible 

hospital, as defined under § 495.200, 

based on common corporate governance 

with a qualifying MA organization, for 

which at least two-thirds of the 

Medicare hospital discharges (or beddays) are of (or for) Medicare 

individuals enrolled under MA plans, as 

well as whether less than one-third of 

Medicare bed-days for the year are 

covered under Part A rather than Part C. 

Incentive payment appeal means an 

appeal challenging only the total 

estimated allowed charges for a 

qualifying EP’s covered professional 

services under § 495.102(b) of this part. 

The appeal could not contest an 

individual claims payment or coverage 

decisions, but only the inclusion of final 

claims used to calculate the incentive 

payment amount or the inclusion of 

claims used to calculate the incentive 

payment amount. Incentive payment 

appeals may also include appeals 

challenging a subsequent Federal 

determination that the incentive 

payment calculation amount was 

incorrect (including determinations that 

the incentive payment was duplicative). 

Meaningful use appeal means an 

appeal challenging a determination or 

finding that a provider was not a 

meaningful EHR user, or that it did not 

use Certified EHR Technology. 

Permissible appeal means an 

eligibility appeal, a meaningful use 

appeal, or an incentive payment appeal. 

Provider means one of the following 

entities that is permitted to file an 

appeal in accordance with the 

requirements specified in this subpart: 

(1) An EP. 

(2) An eligible hospital. 

(3) A CAH. 

(4) A qualifying MA organization on 

behalf of a potentially qualifying MA 

EP. 

(5) A potentially qualifying MAaffiliated eligible hospital. 

(6) A Medicaid eligible hospital. 

§ 495.404 Provider scope and eligibility to 

file. 

Subject to the limitations and 

requirements contained in this subpart, 

only permissible appeals are permitted 

to be filed, only the following providers 

may file appeals, and only for the types 

of appeals specified in this section: 

(a) An EP as defined under § 495.100 

is permitted to file an eligibility appeal, 

a meaningful use appeal, or an incentive 

payment appeal. 

(b) An eligible hospital as defined 

under § 495.100 is permitted to file an 

eligibility appeal or a meaningful use 

appeal. 

(c) A CAH as defined under § 495.4 is 

permitted to file an eligibility appeal or 

a meaningful use appeal. 

(d) A qualifying MA organization as 

defined under § 495.200 is permitted to 

file a meaningful use appeal for a 

potentially qualifying MA EP as defined 

under § 495.200 who has been 

determined not to be a meaningful EHR 

user. 

(e) A potentially qualifying MAaffiliated eligible hospital as defined 

under § 495.200 is permitted to file an 

eligibility appeal described in paragraph 

(ii) of the definition (that is, an appeal 

based on common corporate governance 

with a qualifying MA organization, for 

which at least two-thirds of the 

Medicare hospital discharges (or bed 

days) are of (or for) Medicare 

individuals enrolled under MA plans 

and/or whether less than one-third of 

Medicare bed-days for the year are 

covered under Part A rather than Part C) 

and a meaningful use appeal if 

determined not to be a meaningful EHR 

user. 

(f) A Medicaid-eligible hospital under 

subpart D of this part is permitted to file 

a meaningful use appeal, but only in the 

case that an adverse audit has been 

conducted by CMS. 

§ 495.406 Filing appeals. 

A provider must make all filings or 

requests, and submit all documentation, 

comments, and data through an online 

mechanism and in a manner specified 

by CMS. 

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13828 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 

§ 495.408 General filing rules. 

(a) All relevant issues raised in initial 

filing of appeal. Except under 

extenuating circumstances described in 

paragraph (c)(1) of this section, a 

provider must raise all relevant issues at 

the time of the initial filing of an appeal. 

(b) Deadlines for filing appeals. (1) 

General rules. (i) Except under 

extenuating circumstances described in 

paragraph (c)(2) of this section, an 

appeal filed by a provider after the 

specified deadline is dismissed and 

cannot be refiled. 

(ii) If the filing deadline falls on a 

Saturday, Sunday, or a Federal holiday 

then the deadline for filing the appeal 

is extended to the next business day. 

(iii) CMS may extend the filing 

deadline for providers in response to 

extenuating circumstances that occur 

within the EHR Incentive Program. CMS 

will provide information on our Web 

site at least 7 calendar days before the 

filing deadline providing the new filing 

deadline. 

(2) Deadline for an eligibility appeal. 

An eligibility appeal must be filed no 

later than 30 days after the 2-month 

period following the payment year. 

(3) Deadline for a meaningful use 

appeal. A meaningful use appeal must 

be filed no later than 30 days from the 

date of the demand letter or other 

finding that could result in the 

recoupment of an EHR incentive 

payment. 

(4) Deadline for an incentive payment 

appeal. An incentive payment appeal 

must be filed no later than 60 days from 

the date the incentive payment was 

issued or 60 days from any Federal 

determination that the incentive 

payment amount was incorrect 

(including determinations that the 

payment was duplicative). 

(c) Extenuating circumstances for 

filing—(1) Amendment to raise 

additional issues. A provider— 

(i) May file an amendment to raise 

additional issues, if the provider can 

demonstrate an extenuating 

circumstance existed that prevented all 

relevant issues from being included at 

the time of the initial filing of the 

appeal; 

(ii) Must show, in its amendment 

request, that extenuating circumstances 

existed by submitting documentation of 

occurrences, events, or transactions that 

prevented the additional issues from 

being raised in the initial appeal filing; 

and 

(iii) Must file its amendment claiming 

an extenuating circumstance within 15 

days after the initial filing of the appeal. 

(2) Request an extension of the filing 

deadline. (i) A provider— 

(A) May file a request to extend the 

deadline under paragraph (b) of this 

section, if the provider can demonstrate 

an extenuating circumstance existed 

that prevented the appeal from being 

filed by the applicable deadline; and 

(B) Must show, in its extension 

request, that extenuating circumstances 

existed by submitting documentation of 

occurrences, events, or transactions that 

prevented the appeal from being filed by 

the applicable deadline. 

(ii) The length of an extension granted 

by CMS is based upon documentation 

filed and the reason(s) requested. 

(iii) A request to extend the deadline 

must be filed before the deadline 

expires for the appeal the provider is 

filing. 

(d) Withdrawal of appeal filing. A 

provider may withdraw an appeal at any 

time after the initial appeal filing and 

before an informal review decision is 

issued. The issues raised in the appeal 

filing may be re-filed by the provider 

before the deadline specified in 

paragraph (b) of this section. 

§ 495.410 Other requirements. 

(a) General rule. CMS reviews each 

issue raised in the appeal filing to 

determine if each issue is precluded 

from the appeals process. Appeal issues 

found to be precluded will be 

dismissed. 

(b) Judicial and administrative review. 

Providers have the burden of 

demonstrating that each issue raised in 

the appeal filing is not precluded from 

administrative and judicial review 

under the Act and implementing 

regulations at 42 CFR 413.70(a)(7), 

495.106(f), 495.110, and 495.212. 

(c) Inchoate issues. (1) A provider has 

the burden of doing all of the following: 

(i) Demonstrating that the provider 

met all the EHR Incentive Program 

requirements other than the issue raised 

and should have received an incentive 

payment for the payment year for which 

the appeal is filed. 

(ii) Demonstrating that before the end 

of the payment year for which the 

appeal is filed, the provider allowed 

CMS an opportunity to resolve the issue 

that is raised in the appeal. 

(iii) Demonstrating that CMS was not 

able to resolve the issue by the end of 

the 2 months following the payment 

year for which the appeal is filed. 

(2) The provider must provide 

documentation of the resolution efforts 

described in paragraph (c)(1)(ii) of this 

section. 

(d) Hospital cost report issues. Any 

issue involving an incentive payment 

based upon a hospital cost report must 

be filed with the Provider 

Reimbursement and Review Board. 

Issues raised in an appeal filing that 

involve a hospital cost report will be 

dismissed in accordance with these 

rules. 

§ 495.412 Informal review process and 

decision. 

(a) General rule. The informal review 

process is the first level review in the 

appeals process. 

(b) Supporting documentation—(1) 

Request for additional supporting 

documentation essential to validate an 

issue raised in the appeal. During the 

informal review process, CMS may 

request supporting documentation from 

a provider for an issue that is raised in 

the appeal. Except in extenuating 

circumstances described in this 

paragraph (b), a provider has 7 calendar 

days to comply with the request for 

supporting documentation. 

(2) Failure to submit supporting 

documentation. An issue raised in the 

appeal is dismissed if a provider fails to 

submit supporting documentation 

within 7 calendar days from the date of 

the request by CMS. 

(3) Request for extension before the 

supporting documentation deadline. A 

request for an extension to submit 

supporting documentation may be filed 

if a provider can demonstrate an 

extenuating circumstance existed that 

prevented the supporting 

documentation from being filed by the 

provider within 7 calendar days. 

(i) A provider must show extenuating 

circumstances existed by providing, 

with its request for extension, 

documentation of occurrences, events, 

or transactions that prevented a request 

from being complied within 7 calendar 

days. A request for an extension must be 

filed before the 7 calendar days to 

respond to the request has expired. 

(ii) A request for an extension of the 

time period to submit supporting 

documentation must be filed within 7 

calendar days from the date the request 

was made by CMS. 

(iii) The length of an extension 

granted by CMS is based upon 

documentation submitted and the 

reasons requested. 

(c) Informal review standards. All 

appeal requests are reviewed according 

to the guidelines associated with the 

specific appeal type. 

(1) Eligibility appeals. A provider 

must do all of the following: 

(i) Demonstrate that the provider can 

meet all of the requirements of the EHR 

except for the issue raised. 

(ii) Except for eligibility appeals 

described in part (ii) of the definition 

(that is, appeals involving common 

corporate governance with a qualifying 

MA organization, for which at least twomstockstill on DSK4VPTVN1PROD with PROPOSALS2

Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Proposed Rules 13829 

thirds of the Medicare hospital 

discharges (or bed-days) are of (or for) 

Medicare individuals enrolled under 

MA plans and/or whether less than onethird of Medicare bed-days for the year 

are covered under Part A rather than 

Part C), demonstrate that the issue 

raised in the appeal filing was the result 

of a circumstance outside of a provider’s 

control and prevented the provider from 

receiving an incentive payment. 

(iii) Submit evidence that an action 

was taken to participate in the EHR 

Incentive Program. 

(iv) For eligibility appeals described 

in part (ii) of the definition, demonstrate 

in accordance with subpart C of this 

part that either: 

(A) The MA-affiliated hospital is 

under common corporate governance 

with a qualifying MA organization, for 

which at least two-thirds of the 

Medicare hospital discharges (or beddays) are of (or for) Medicare 

individuals enrolled under MA plans; 

and/or 

(B) The MA-affiliated eligible hospital 

has less than one-third of Medicare beddays for the year covered under Part A 

rather than Part C. 

(2) Meaningful use appeals. A 

provider must do all of the following: 

(i) Demonstrate that the provider 

successfully meets the meaningful use 

objective and associated measure 

discussed in the demand letter or other 

finding for recoupment of the EHR 

incentive payment. 

(ii) Demonstrate that the provider 

used Certified EHR Technology during 

the EHR reporting period for the 

payment year for which the appeal was 

filed. 

(3) Incentive payment appeals. 

Providers appealing the amount of the 

incentive payment must do the 

following: 

(i) Demonstrate that all relevant 

claims were submitted timely and 

appropriately and were either not used 

or misused in accordance with 

§ 495.102(a)(2) of this part. 

(ii) Demonstrate that the timely and 

appropriately submitted claims were not 

used in calculating the amount of the 

EHR incentive payment. 

(d) Informal review decision. (1) CMS 

issues an informal review decision 

within 90 days of the initial appeal 

filing, unless an extension or 

amendment was granted to the provider 

or CMS. 

(2) An informal review decision under 

this section represents CMS’s final 

decision, unless a provider files a 

reconsideration request under § 495.414 

of this subpart. 

§ 495.414 Final reconsiderations. 

(a) Reconsideration request. A 

provider dissatisfied with the CMS 

informal review decision under 

§ 495.412 of this part may file a request 

for reconsideration of issues denied in 

that decision. The request for 

reconsideration may include comments 

and documentation to support the 

position that the issues raised in the 

appeal should not have been denied. 

(b) Deadline for reconsideration 

requests. (1) Except as provided in 

paragraph (b)(2) of this section, 

reconsideration requests must be filed 

within 15 days from the date of the 

informal review decision. 

(2) A provider may request a one-time 

extension of 15 additional days to file 

the reconsideration request, if the 

provider can demonstrate that the 

informal review decision was not 

received by the provider (or provider’s 

representative) within 5 days from the 

date of the decision. 

(c) Final decision. CMS renders a final 

decision within 10 days of the date the 

provider files the request for 

reconsideration. 

(d) Reconsideration request not filed. 

If a provider does not file a request for 

reconsideration within the time period 

specified in paragraph (b) of this 

section, then the informal review 

decision is CMS’s final decision. 

(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: February 8, 2012. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: February 21, 2012. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2012–4443 Filed 2–23–12; 4:15 pm] 

BILLING CODE 4120–01–P 

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