Vol. 80 Monday, 

No. 60 March 30, 2015 

Part II 

Department of Health and Human Services 

Centers for Medicare and Medicaid Services 

42 CFR Part 495 

Office of the Secretary 

45 CFR Part 170 

Medicare and Medicaid Programs; Electronic Health Record Incentive 

Program—Stage 3; 2015 Edition Health Information Technology (Health IT) 

Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) 

Definition, and ONC Health IT Certification Program Modifications; 

Proposed Rules 

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16732 Federal Register / Vol. 80, No. 60 / Monday, March 30, 2015 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 495 

[CMS–3310–P] 

RIN 0938–AS26 

Medicare and Medicaid Programs; 

Electronic Health Record Incentive 

Program—Stage 3 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This Stage 3 proposed rule 

would specify the meaningful use 

criteria that eligible professionals (EPs), 

eligible hospitals, and critical access 

hospitals (CAHs) must meet in order to 

qualify for Medicare and Medicaid 

electronic health record (EHR) incentive 

payments and avoid downward 

payment adjustments under Medicare 

for Stage 3 of the EHR Incentive 

Programs. It would continue to 

encourage electronic submission of 

clinical quality measure (CQM) data for 

all providers where feasible in 2017, 

propose to require the electronic 

submission of CQMs where feasible in 

2018, and establish requirements to 

transition the program to a single stage 

for meaningful use. Finally, this Stage 3 

proposed rule would also change the 

EHR reporting period so that all 

providers would report under a full 

calendar year timeline with a limited 

exception under the Medicaid EHR 

Incentive Program for providers 

demonstrating meaningful use for the 

first time. These changes together 

support our broader efforts to increase 

simplicity and flexibility in the program 

while driving interoperability and a 

focus on patient outcomes in the 

meaningful use program. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on May 29, 2015. 

ADDRESSES: In commenting, please refer 

to file code CMS–3310–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–3310–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–3310–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) 786–7195 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, 

Medicare EHR Incentive Program and 

Medicare payment adjustment 

Elisabeth Myers (CMS), (410) 786–4751, 

Medicare EHR Incentive Program 

Thomas Romano (CMS), (410) 786– 

0465, Medicaid EHR Incentive 

Program 

Ed Howard (CMS), (410) 786–6368, 

Medicare Advantage 

Deborah Krauss (CMS), (410) 786–5264, 

clinical quality measures 

Alesia Hovatter (CMS), (410) 786–6861, 

clinical quality measures 

Elise Sweeney Anthony (ONC), (202) 

475–2485, certification definition 

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 

API Application-Program Interface 

ARRA American Recovery and 

Reinvestment Act of 2009 

AAC Average Allowable Cost (of certified 

EHR Technology) 

ACO Accountable Care Organization 

AIU Adopt, Implement, Upgrade (certified 

EHR Technology) 

CAH Critical Access Hospitals 

CAHPS Consumer Assessment of 

Healthcare Providers and Systems 

CCN CMS Certification Number 

CDC Centers for Disease Control 

CEHRT Certified Electronic Health Record 

Technology 

CFR Code of Federal Regulations 

CHIP Children’s Health Insurance Program 

CHIPRA Children’s Health Insurance 

Program Reauthorization Act of 2009 

CMS Centers for Medicare and Medicaid 

Services 

CPOE Computerized Physician Order Entry 

CQM Clinical Quality Measure 

CY Calendar Year 

EHR Electronic Health Record 

EP Eligible Professional 

EPO Exclusive Provider Organization 

FACA Federal Advisory Committee Act 

FFP Federal Financial Participation 

FFY Federal Fiscal Year 

FFS Fee-for-Service 

FQHC Federally Qualified Health Center 

FTE Full Time Equivalent 

FY Fiscal Year 

HEDIS Healthcare Effectiveness Data and 

Information Set 

HHS Department of Health and Human 

Services 

HIE Health Information Exchange 

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HIT Health Information Technology 

HITPC Health Information Technology 

Policy Committee 

HIPAA Health Insurance Portability and 

Accountability Act of 1996 

HITECH Health Information Technology for 

Economic and Clinical Health Act 

HMO Health Maintenance Organization 

HOS Health Outcomes Survey 

HPSA Health Professional Shortage Area 

HRSA Health Resources and Services 

Administration 

IAPD Implementation Advanced Planning 

Document 

ICR Information Collection Requirement 

IHS Indian Health Service 

IPA Independent Practice Association 

IPPS Inpatient Prospective Payment System 

IQR Inpatient Quality Reporting 

IT Information Technology 

MA Medicare Advantage 

MAC Medicare Administrative Contractor 

MCO Managed Care Organization 

MITA Medicaid Information Technology 

Architecture 

MMIS Medicaid Management Information 

Systems 

MSA Medical Savings Account 

MU Meaningful Use 

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 

NQF National Quality Forum 

ONC Office of the National Coordinator for 

Health Information Technology 

PAHP Prepaid Ambulatory Health Plan 

PAPD Planning Advanced 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 

PQRS Physician Quality Reporting System 

PHI Protected Health Information 

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 

I. Executive Summary and Background 

A. Executive Summary 

1. Purpose of Regulatory Action 

a. Need for Regulatory Action 

In this proposed rule, we specify the 

policies that would be applicable for 

Stage 3 of the Medicare and Medicaid 

EHR Incentive Programs. Under Stage 3, 

we are proposing a set of requirements 

that EPs, eligible hospitals, and CAHs 

must achieve in order to meet 

meaningful use, qualify for incentive 

payments under the Medicare and 

Medicaid EHR Incentive Programs, and 

avoid downward payment adjustments 

under Medicare. These Stage 3 

requirements focus on the advanced use 

of certified EHR technology (CEHRT) to 

promote health information exchange 

and improved outcomes for patients. 

Stage 3 of meaningful use is expected 

to be the final stage and would 

incorporate portions of the prior stages 

into its requirements. In addition, 

following a proposed optional year in 

2017, beginning in 2018 all providers 

would report on the same definition of 

meaningful use at the Stage 3 level 

regardless of their prior participation, 

moving all participants in the EHR 

Incentive Programs to a single stage of 

meaningful use in 2018. The 

incorporation of the requirements into 

one stage for all providers is intended to 

respond to stakeholder input regarding 

the complexity of the program, the 

success of certain measures which are 

part of the meaningful use program to 

date, and the need to set a long-term, 

sustainable foundation based on a 

consolidated set of key advanced use 

objectives for the Medicare and 

Medicaid EHR Incentive Programs. 

In addition, we propose changes to 

the EHR reporting period, timelines, and 

structure of the Medicare and Medicaid 

EHR Incentive Programs. We believe 

these changes would provide a flexible, 

clear framework to reduce provider 

burden, streamline reporting, and 

ensure future sustainability of the 

Medicare and Medicaid EHR Incentive 

Programs. These changes together lay a 

foundation for our broader efforts to 

support interoperability and quality 

initiatives focused on improving patient 

outcomes. 

b. Legal Authority for the Regulatory 

Action 

The American Recovery and 

Reinvestment Act of 2009 (ARRA) (Pub. 

L. 111–5) amended Titles XVIII and XIX 

of the Social Security Act (the Act) to 

authorize incentive payments to EPs, 

eligible hospitals, and CAHs, and 

Medicare Advantage (MA) organizations 

to promote the adoption and meaningful 

use of Certified Electronic Health 

Record Technology (CEHRT). Sections 

1848(o), 1853(l) and (m), 1886(n), and 

1814(l) of the Act provide the statutory 

basis for the Medicare incentive 

payments made to meaningful EHR 

users. These statutory provisions govern 

EPs, MA organizations (for certain 

qualifying EPs and hospitals that 

meaningfully use CEHRT), subsection 

(d) hospitals and critical access 

hospitals (CAHs), respectively. Sections 

1848(a)(7), 1853(l) and (m), 

1886(b)(3)(B), and 1814(l) of the Act also 

establish downward payment 

adjustments, beginning with calendar or 

fiscal year (FY) 2015, for EPs, MA 

organizations, subsection (d) hospitals, 

and CAHs that are not meaningful users 

of CEHRT for certain associated 

reporting periods. Sections 1903(a)(3)(F) 

and 1903(t) of the Act provide the 

statutory basis for Medicaid incentive 

payments. (There are no payment 

adjustments under Medicaid). (For a 

more detailed explanation of the 

statutory basis for the EHR incentive 

payments, see the July 28, 2010 Stage 1 

final rule titled, ‘‘Medicare and 

Medicaid Programs; Electronic Health 

Record Incentive Program; Final Rule’’ 

(75 FR 44316 through 44317)). 

2. Summary of Major Provisions 

a. Meaningful Use in 2017 and 

Subsequent Years 

The Stage 1 final rule sets the 

foundation for the Medicare and 

Medicaid EHR Incentive Programs by 

establishing requirements for the 

electronic capture of clinical data, 

including providing patients with 

electronic copies of their health 

information. We outlined Stage 1 

meaningful use criteria, and finalized 

core and menu objectives for EPs, 

eligible hospitals, and CAHs. (For a full 

discussion of Stage 1 of meaningful use, 

we refer readers to the Stage 1 final rule 

(75 FR 44313 through 44588).) 

In the September 4, 2012 Stage 2 final 

rule (77 FR 53967 through 54162), we 

focused on the next step after the 

foundation of data capture in Stage 1, 

the exchange of that essential health 

data among health care providers and 

patients to improve care coordination. 

To this end, we maintained the same 

core-menu structure for several finalized 

Stage 1 core and menu objectives. We 

finalized that EPs must meet the 

measure for or qualify for an exclusion 

to 17 core objectives and 3 of 6 menu 

objectives. We finalized that eligible 

hospitals and CAHs must meet the 

measure or qualify for an exclusion to 

16 core objectives and 3 of 6 menu 

objectives. We combined several Stage 1 

measures included into Stage 2. With 

the experience providers gained from 

the Stage 1 final rule, we also increased 

functional objective measure thresholds 

in Stage 2 to increase efficiency, 

effectiveness, and flexibility. We also 

finalized a set of clinical quality 

measures (CQMs) for all providers 

participating in any stage of the program 

to report to CMS beginning in 2014. (For 

a full discussion of the meaningful use 

objectives and measures, and the CQMs 

we finalized under Stage 2, we refer 

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readers to the Stage 2 final rule at 77 FR 

53967 through 54162.) 

In this Stage 3 proposed rule, we 

build on the groundwork established in 

the Stage 1 and Stage 2 final rules, 

including continuing our goal started 

under Stage 2 to increase interoperable 

health data sharing among providers. In 

addition, this Stage 3 proposed rule 

would also focus on the advanced use 

of EHR technology to promote improved 

patient outcomes and health 

information exchange. We also propose 

to continue improving program 

efficiency, effectiveness, and flexibility 

by making changes to the Medicare and 

Medicaid EHR Incentive Programs that 

simplify reporting requirements and 

reduce program complexity. These 

changes proposed respond to comments 

received in earlier rulemaking that 

expressed confusion and concerns 

regarding increased reporting burden 

related to the number of program 

requirements, the multiple stages of 

program participation, and the timing of 

EHR reporting periods. In order to 

address these stakeholder concerns, one 

significant change we propose for Stage 

3 includes establishing a single set of 

objectives and measures (tailored to EP 

or eligible hospital/CAH) to meet the 

definition of meaningful use. This new, 

streamlined definition of meaningful 

use proposed for Stage 3 would be 

optional for any provider who chooses 

to attest to these objectives and 

measures for an EHR reporting period in 

2017; and would be required for all 

eligible providers—regardless of prior 

participation in the EHR Incentive 

Program—for an EHR reporting period 

in 2018 and subsequent years. 

In addition to reducing program 

complexity, the Stage 3 proposed rule 

would further support efforts to align 

the EHR Incentive Programs with other 

CMS quality reporting programs that use 

certified EHR technology, such as the 

Hospital Inpatient Quality Reporting 

(IQR) and Physician Quality Reporting 

System (PQRS) programs, as well as 

continue alignment across care settings 

for providers demonstrating meaningful 

use. This alignment would both reduce 

provider burden associated with 

reporting on multiple CMS programs 

and enhance CMS operational 

efficiency. The Stage 3 proposed rule 

and ONC’s 2015 Edition of Health 

Information Technology (Health IT) 

Certification Criteria, 2015 Edition Base 

Electronic Health Record (EHR) 

Definition, and ONC Health IT 

Certification Program Modifications 

(hereinafter referenced as the ‘‘2015 

Edition proposed rule’’) published 

elsewhere in this edition of the Federal 

Register would also continue to support 

the privacy and security of patient 

health information within certified 

health IT. 

b. Meaningful Use Requirements, 

Objectives and Measures for 2017 and 

Subsequent Years 

Under this Stage 3 proposed rule, 

with the exception of Medicaid 

providers in their first year of 

demonstrating meaningful use as 

detailed in section II.F.1. of this 

proposed rule, all providers (EPs, 

eligible hospitals, and CAHs) would 

report on a calendar year EHR reporting 

period beginning in calendar year 2017. 

This proposal builds on efforts to align 

the EHR reporting period with reporting 

periods for other quality reporting 

programs identified in the Stage 2 final 

rule (77 FR 53971 through 53975 and 

54049 through 54051) and the FY 2015 

Hospital Inpatient Prospective Payment 

Systems (IPPS) final rule (79 FR 49854 

through 50449). In addition, all 

providers, other than Medicaid EPs and 

eligible hospitals demonstrating 

meaningful use for the first time, would 

be required to attest based on a full year 

of data for a single set of meaningful use 

objectives and measures to demonstrate 

Stage 3 of meaningful use, which is 

proposed as optional for an EHR 

reporting period in 2017 and mandatory 

for an EHR reporting period in 2018, 

and subsequent years for all providers 

participating in the Medicare and 

Medicaid EHR Incentive Programs. 

The methodology for the selection of 

the proposed Stage 3 objectives and 

measures for the Medicare and 

Medicaid EHR Incentive Programs 

included the following: 

• Review attestation data for Stages 1 

and 2 of meaningful use. 

• Conduct listening sessions and 

interviews with providers, EHR system 

developers, regional extension centers, 

and health care provider associations. 

• Review recommendations from 

government agencies and advisory 

committees focused on health care 

improvement, such as the Health 

Information Technology (HIT) Policy 

Committee, the National Quality Forum 

(NQF), and the Centers for Disease 

Control (CDC). 

The information we gathered from 

these sources focused on analyzing 

measure performance, implementing 

discrete EHR functionalities and 

standards, and examining objectives and 

measures presenting the best 

opportunity to improve patient 

outcomes and enhance provider 

support. 

Based on this analysis, we are 

proposing a set of 8 objectives with 

associated measures designed to do all 

of the following: 

• Align with national health care 

quality improvement efforts. 

• Promote interoperability and health 

information exchange. 

• Focus on the 3-part aim of reducing 

cost, improving access, and improving 

quality. 

We intend to have this Stage 3 

proposed rule be the last stage of the 

meaningful use framework, which 

leverages the structure identified in the 

Stage 1 and Stage 2 final rules, while 

simultaneously establishing a single set 

of objectives and measures designed to 

promote best practices and continued 

improvement in health outcomes in a 

sustainable manner. Measures in the 

Stage 1 and Stage 2 final rules that 

included paper-based workflows, chart 

abstraction, or other manual actions 

would be removed or transitioned to an 

electronic format utilizing EHR 

functionality for Stage 3. In addition, we 

are proposing the removal of ‘‘topped 

out’’ measures, or measures that are no 

longer useful in gauging performance, in 

order to reduce the reporting burden on 

providers for measures already 

achieving widespread adoption. 

c. Clinical Quality Measurement 

EPs, eligible hospitals, and CAHs 

must report CQMs in order to qualify for 

incentive payments under the Medicare 

and Medicaid EHR Incentive Programs 

and avoid downward payment 

adjustments under Medicare. 

We are committed to continuing the 

electronic calculation and reporting of 

key clinical data through the use of 

CQMs. We are also focused on 

improving alignment of reporting 

requirements for CMS programs using 

EHR technology, maintaining flexibility 

with reporting requirements while 

streamlining reporting mechanisms for 

providers, and increasing quality data 

integrity. 

This proposed rule addresses quality 

reporting alignment on several fronts. 

Our long-term vision seeks to have 

hospitals, clinicians, and other health 

care providers report through a single, 

aligned mechanism for multiple CMS 

programs. In the Stage 2 final rule, we 

outlined preliminary alignment options 

for quality reporting programs with the 

EHR Incentive Programs as the first step 

toward that vision (77 FR 54053). 

In order to facilitate continuous 

quality improvement, we need a method 

to allow changes to meaningful use 

CQMs and the associated reporting 

requirements on an ongoing basis. For 

other CMS quality reporting programs, 

changes occur through the annual 

Medicare payment rules, such as the 

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Physician Fee Schedule (PFS) and the 

IPPS rules. Including CQMs in these 

annual rules would allow us to capture 

changes and updates annually. 

Therefore, we intend to further support 

alignment between the Medicare and 

Medicaid EHR Incentive Programs and 

other CMS quality reporting programs, 

such as PQRS and Hospital IQR, by 

including the reporting requirements for 

CQMs for providers demonstrating 

meaningful use in future rulemaking. 

We propose to continue encouraging 

CQM data submission through 

electronic submission for Medicare 

participants in 2017, and to require 

electronic submission of CQMs where 

feasible beginning in 2018 for Medicare 

providers demonstrating meaningful 

use. (We further discuss Medicaid CQM 

submission in section II.F.3. of this 

proposed rule.) 

d. Payment Adjustments and Hardship 

Exceptions 

The statute requires Medicare 

payment adjustment beginning in 2015. 

For the Stage 3 proposed rule, we 

propose to maintain all payment 

adjustment provisions for all EPs, 

eligible hospitals, and CAHs finalized in 

the Stage 2 final rule (77 FR 54093 

through 54113 and 54115 through 

54119) except for a change to the 

relationship between the EHR reporting 

period year and the payment adjustment 

year for CAHs. We are proposing a 

change to the timing of the EHR 

reporting period and related deadlines 

for attestations and hardship exceptions 

for CAHs in relation to the payment 

adjustment year, in order to 

accommodate a transition to EHR 

reporting for meaningful use on the 

calendar instead of the fiscal year 

timeline. The payment adjustment 

provisions being maintained in the 

Stage 3 proposed rule include the 

process we finalized in Stage 2 by 

which a prior EHR reporting period 

determines a payment adjustment. We 

also maintain the four categories of 

exceptions based on all of the following: 

• The lack of availability of internet 

access or barriers to obtain IT 

infrastructure. 

• A time-limited exception for newly 

practicing EPs or new hospitals that 

would not otherwise be able to avoid 

payment adjustments. 

• Unforeseen circumstances such as 

natural disasters that would be handled 

on a case-by-case basis. 

• (EP only) exceptions due to a 

combination of clinical features limiting 

a provider’s interaction with patients or, 

if the EP practices at multiple locations, 

lack of control over the availability of 

CEHRT at practice locations constituting 

50 percent or more of their encounters. 

e. Modifications to the Medicaid EHR 

Incentive Program 

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

the Act provide the statutory basis for 

the Medicaid EHR Incentive Program. 

For this Stage 3 proposed rule, we 

propose that under the proposed 

changes to EHR reporting periods that 

would begin in 2017, Medicaid EPs and 

eligible hospitals demonstrating 

meaningful use for the first time in the 

Medicaid EHR Incentive Program would 

be required to attest for an EHR 

reporting period of any continuous 90- 

day period in the calendar year for 

purposes of receiving an incentive, as 

well as avoiding the payment 

adjustment under the Medicare 

Program. 

We are proposing to continue to allow 

states to set up a CQM submission 

process that Medicaid EPs and eligible 

hospitals may use to report on CQMs for 

2017 and subsequent years. We also 

propose amendments to state reporting 

on providers who are participating in 

the Medicaid EHR Incentive Program as 

well as state reporting on 

implementation and oversight activities. 

f. Summary of Costs and Benefits 

Upon finalization, the provisions in 

this proposed rule are anticipated to 

have an annual effect on the economy 

of $100 million or more, making it an 

economically significant rule under the 

Executive Order and a major rule under 

the Congressional Review Act. 

Accordingly, we have prepared a 

Regulatory Impact Analysis that to the 

best of our ability presents the costs and 

benefits of the final rule. The total 

federal cost of the Medicare and 

Medicaid EHR Incentive Programs 

between 2017 and 2020 is estimated to 

be $3.7 billion in transfers. In this 

proposed rule we do not estimate total 

costs and benefits to the provider 

industry, but rather provide a possible 

per EP and per eligible hospital outlay 

for implementation and maintenance. 

Nonetheless, we believe there are 

substantial benefits that can be obtained 

by society (perhaps accruing to eligible 

hospitals and EPs), including cost 

reductions related to improvements in 

patient safety and patient outcomes and 

cost savings benefits through 

maximizing efficiencies in clinical and 

business processes facilitated by 

certified health IT. 

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

OF THE HITECH EHR INCENTIVE PROGRAM

[Fiscal year—in billions] 

Fiscal year 

Medicare eligible Medicaid eligible 

Total 

Hospitals Professionals Hospitals Professionals 

2017 ..................................................................................... $1.6 $0.3 $0.4 $0.8 $3.1 

2018 ..................................................................................... 0.0 ¥0.2 0.1 0.5 0.4 

2019 ..................................................................................... 0.0 ¥0.2 0.0 0.3 0.1 

2020 ..................................................................................... 0.0 ¥0.1 0.0 0.2 0.1 

B. Overview of the Regulatory History 

The American Recovery and 

Reinvestment Act of 2009 (Pub. L. 111– 

5) (ARRA) amended Titles XVIII and 

XIX of the Act to authorize incentive 

payments to EPs, eligible hospitals, and 

CAHs, and MA organizations to promote 

the adoption and meaningful use of 

CEHRT. In the July 28, 2010 Federal 

Register (75 FR 44313 through 44588), 

we published a final rule (‘‘Medicare 

and Medicaid Programs; Electronic 

Health Record Incentive Program’’, or 

‘‘Stage 1 final rule’’) 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. For a full explanation of 

the amendments made by ARRA, see the 

Stage 1 final rule at 75 FR 44316. In that 

Stage 1 final rule, we also detailed that 

the Medicare and Medicaid EHR 

Incentive Program would consist of 

three different stages of meaningful use 

requirements. 

In the September 4, 2012 Federal 

Register (77 FR 53967 through 54162), 

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we published a final rule (‘‘Medicare 

and Medicaid Programs; Electronic 

Health Record Incentive Program-Stage 

2; Final Rule’’ or ‘‘Stage 2 final rule’’) 

that specified the Stage 2 criteria that 

EPs, eligible hospitals, and CAHs would 

have to meet in order to qualify for 

incentive payments. In addition, the 

Stage 2 final rule finalized payment 

adjustments and other program 

participation requirements under 

Medicare for covered professional and 

hospital services provided by EPs, 

eligible hospitals, and CAHs failing to 

demonstrate meaningful use of CEHRT, 

and finalized the revision of certain 

Stage 1 criteria, and finalized criteria 

that applied regardless of stage. 

In the December 7, 2012 Federal 

Register (77 FR 72985), CMS and ONC 

jointly published an interim final rule 

with comment period (IFC) titled 

‘‘Health Information Technology: 

Revisions to the 2014 Edition Electronic 

Health Record Certification Criteria; and 

Medicare and Medicaid Programs; 

Revisions to the Electronic Health 

Record Incentive Program’’ (December 

7, 2012 IFC). The Department of Health 

and Human Services (HHS) issued the 

IFC to replace the Data Element Catalog 

(DEC) standard and the Quality 

Reporting Document Architecture 

(QRDA) Category III standard adopted in 

the final rule published on September 4, 

2012 in the Federal Register with 

updated versions of those standards. 

The December 7, 2012 IFC also revised 

the Medicare and Medicaid EHR 

Incentive Programs by— 

• Adding an alternative measure for 

the Stage 2 meaningful use (MU) 

objective for hospitals to provide 

structured electronic laboratory results 

to ambulatory providers; 

• Correcting the regulation text for 

the measures associated with the 

objective for hospitals to provide 

patients the ability to view online, 

download, and transmit information 

about a hospital admission; and 

• Making the case number threshold 

exemption for CQM reporting applicable 

for eligible hospitals and CAHs 

beginning with FY 2013. 

The December 7, 2012 IFC also 

provided notice of our intention to issue 

technical corrections to the electronic 

specifications for CQMs released on 

October 25, 2012. 

In the September 4, 2014 Federal 

Register (79 FR 52910 through 52933) 

CMS and ONC published a final rule 

titled ‘‘Medicare and Medicaid 

Programs; Modifications to the Medicare 

and Medicaid Electronic Health Record 

(EHR) Incentive Program for 2014 and 

Other Changes to the EHR Incentive 

Program; and Health Information 

Technology: Revisions to the Certified 

EHR Technology Definition and EHR 

Certification Changes Related to 

Standards; Final Rule’’ (‘‘2014 CEHRT 

Flexibility final rule’’). Due to issues 

related to EHR technology certified to 

the 2014 Edition availability delays, the 

2014 CEHRT Flexibility final rule 

included policies allowing EPs, eligible 

hospitals, and CAHs that could not fully 

implement EHR technology certified to 

the 2014 Edition for an EHR reporting 

period in 2014 to continue to use one 

of the following options for reporting 

periods in CY 2014 and FY 2014, 

respectively— 

• EHR technology certified to the 

2011 Edition; or 

• A combination of EHR technology 

certified to the 2011 Edition and EHR 

technology certified to the 2014 Edition 

for the EHR reporting periods. 

These CEHRT options applied only to 

those providers that could not fully 

implement EHR technology certified to 

the 2014 Edition to meet meaningful use 

for an EHR reporting period in 2014 due 

to delays in 2014 Edition availability. 

Although the 2014 CEHRT flexibility 

final rule did not alter the attestation or 

hardship exception application 

deadlines for 2014, it did make changes 

to the attestation process to support 

these flexible options for CEHRT. This 

2014 CEHRT Flexibility final rule also 

discussed the provisions of the 

December 7, 2012 IFC and finalized 

policies relating to the provisions 

contained in the December 7, 2012 IFC. 

In the November 13, 2014, Federal 

Register, we published an interim final 

rule with comment period, under the 

Medicare Program; Revisions to 

Payment Policies Under the Physician 

Fee Schedule, Clinical Laboratory Fee 

Schedule, Access to Identifiable Data for 

the Center for Medicare and Medicaid 

Innovation Models & Other Revisions to 

Part B for CY 2015; Final Rule (79 FR 

67976 through 67978) (November 13, 

2014 IFC). Under this November 13, 

2014 IFC, we recognized a hardship 

exception for EPs and eligible hospitals 

for 2014 under the established category 

of extreme and uncontrollable 

circumstances in accordance with the 

Secretary’s discretionary authority. To 

accommodate this hardship exception, 

we further extended the hardship 

application deadline for EPs and eligible 

hospitals to November 30 for 2014 only. 

We also amended the regulations to 

allow CMS to specify a later hardship 

application deadline for certain 

hardship categories for EPs, eligible 

hospitals, and CAHs. 

For Stages 1 and 2, CMS and ONC 

worked closely to ensure that the 

definition of meaningful use of CEHRT 

and the standards and certification 

criteria for CEHRT were coordinated. 

Current ONC regulations may be found 

at 45 CFR part 170. For this Stage 3 

proposed rule, CMS and ONC will again 

work together to align our regulations. 

We urge those interested in this Stage 

3 proposed rule to also review the ONC 

2015 Edition proposed rule, which is 

published elsewhere in this Federal 

Register. Readers may also visit: 

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

EHRincentiveprograms and http://

www.healthit.gov for more information 

on the efforts at the Department of 

Health and Human Services (HHS) to 

advance HIT initiatives. 

II. Provisions of the Proposed 

Regulations 

A. Meaningful Use Requirements, 

Objectives, and Measures for 2017 and 

Subsequent Years 

1. Definitions Across the Medicare Feefor-Service, Medicare Advantage, and 

Medicaid Programs 

a. Uniform Definitions 

As discussed in both the Stage 1 and 

2 final rules, we finalized several 

uniform definitions applicable for the 

Medicare FFS, Medicare Advantage, and 

Medicaid EHR Incentive Programs. We 

set forth these uniform definitions in 

part 495 subpart A of the regulations. 

We propose to maintain these 

definitions, unless stated otherwise in 

this proposed rule. (For further 

discussion of the uniform definitions 

finalized previously, we refer readers to 

the Stage 1 and Stage 2 final rules at 75 

FR 44317 through 44321 and 77 FR 

53972). 

As discussed in sections II.A.1.c.(1). 

and (2). of this proposed rule, we are 

proposing a single set of criteria for 

meaningful use (‘‘Stage 3’’) in order to 

eliminate the varying stages of the EHR 

Incentive Programs. We propose that 

this Stage 3 definition of meaningful use 

would be optional for providers in 2017 

and mandatory for all providers 

beginning in 2018. To support Stage 3, 

we propose revising the uniform 

definitions under 42 CFR 495.4 for 

‘‘EHR reporting period’’ and ‘‘EHR 

reporting period for a payment 

adjustment year,’’ as explained later in 

this section. The proposed revisions to 

these uniform definitions include 

eliminating the current 90-day EHR 

reporting period for EPs, eligible 

hospitals, and CAHs demonstrating 

meaningful use for the first time, and 

instead creating a single EHR reporting 

period aligned to the calendar year. The 

proposed removal of the 90-day EHR 

reporting period would not apply to 

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Medicaid EPs and eligible hospitals 

demonstrating meaningful use for the 

first time. We believe eliminating the 

90-day EHR reporting period for most 

providers would simplify reporting, by 

aligning providers on the same EHR 

reporting timeline across all settings. In 

addition, a single EHR reporting period 

on the calendar year would align the 

EHR Incentive Program with other CMS 

quality reporting programs using 

certified EHR technology such as the 

Hospital IQR Program and PQRS. 

Finally, a single EHR reporting period 

based on the calendar year allows for a 

single attestation period, thereby 

enabling the HHS systems to better 

capture data, conduct enhanced stress 

testing and issue resolution, and 

improve quality assurance of systems 

before each deployment. We detail the 

proposed revisions to each of the 

uniform definitions later in this section. 

b. Meaningful EHR User 

In the Stage 3 proposed rule, we 

propose to modify the definition of 

‘‘Meaningful EHR User’’ under 42 CFR 

495.4 to include the Stage 3 objectives 

and measures defined at § 495.7. 

The definition of a ‘‘Meaningful EHR 

User’’ under the Act requires the use of 

certified electronic health record 

technology (CEHRT) (see, for example, 

section 1848(o)(2) of the Act). We note 

that the term CEHRT is a defined term 

for the purpose of meeting the objectives 

of the EHR Incentive Programs (defined 

at § 495.4). The term references ONC’s 

certification criteria for a ‘‘Base EHR,’’ 

other ONC certification criteria required 

in the EHR Incentive Programs and the 

definition of a ‘‘Meaningful EHR User.’’ 

References to CEHRT within this 

proposed rule are to certification criteria 

that are required for purposes of the 

EHR Incentive Programs. We recognize 

that CEHRT is just one form of health 

IT. For this reason, this proposed rule 

also includes references to ‘‘health IT’’ 

where appropriate to capture the 

broader category of technologies where 

applicable. 

c. Definition of Meaningful Use 

(1) Considerations in Defining 

Meaningful Use 

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

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

identified the broad goal of expanding 

the use of EHRs through the concept of 

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

the Act also requires that Medicaid 

providers adopt, implement, upgrade or 

meaningfully use CEHRT if they are to 

receive incentives under Title XIX. 

CEHRT used in a meaningful way is one 

piece of the broader HIT infrastructure 

needed to reform the health care system 

and improve health care quality, 

efficiency, and patient safety. This 

vision of reforming the health care 

system and improving health care 

quality, efficiency, and patient safety 

should inform the definition of 

meaningful use. 

As we explained in the Stage 1 and 

Stage 2 rules, 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 rule, 

we laid out a phased approach to 

meaningful use. Such a phased 

approach encompasses reasonable 

criteria for meaningful use based on 

currently available technology 

capabilities and provider practice 

experience, and builds up to a more 

robust definition of meaningful use as 

technology and capabilities evolve. The 

HITECH Act acknowledges the need for 

this balance by granting the Secretary 

the discretion to require more stringent 

measures of meaningful use over time. 

Ultimately, consistent with other 

provisions of law, meaningful use of 

CEHRT should result in health care that 

is patient centered, evidence-based, 

prevention-oriented, efficient, and 

equitable. 

As stated in the Stage 2 final rule (77 

FR 53973), we anticipated the Stage 3 

criteria for meaningful use would focus 

on promoting improvements in quality, 

efficiency, and safety leading to 

improved health outcomes. We also 

anticipated that Stage 3 would focus on 

clinical decision support for national 

high priority conditions; improving 

patient access to self-management tools; 

improving access to comprehensive 

patient data through robust, secure, 

patient-centered health information 

exchange; and improvements in 

population health. 

For this Stage 3 proposed rule, we 

seek to streamline the criteria for 

meaningful use. We intend to do this 

by— 

• Creating a single stage of 

meaningful use objectives and measures 

(Stage 3), which would be optional for 

all providers in 2017 and mandatory for 

all providers in 2018; 

• Allowing providers flexible options 

for 2017; 

• Changing the EHR reporting period 

to a full calendar year for all providers; 

and 

• Aligning with other CMS quality 

reporting programs using certified 

health IT such as PQRS and Hospital 

IQR for clinical quality measurement. 

(a) Meaningful Use Stages 

Under the phased approach to 

meaningful use, we updated the criteria 

for meaningful use through staggered 

rulemaking, which covered Stages 1 and 

2 of the EHR Incentive Program. For 

further explanation of the criteria we 

finalized under Stages 1 and 2, 

including the recent final rule extending 

Stage 2, we refer readers to 75 FR 44314 

through 44588, 77 FR 53968 through 

54162, and 79 FR 52910 through 52933. 

The current progression of the stages is 

outlined in Table 2. 

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 * 1 or 2 2 2 3 3 TBD TBD TBD 

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

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

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

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

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

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

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

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

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In the Stage 2 final rule (77 FR 53974), 

we also stated that we would indicate in 

future rulemaking our intent for the 

potential development of stages or 

further criteria beyond Stage 3. In this 

proposed rule, we intend for Stage 3 to 

be the final stage in meaningful use and 

that no further stages would be 

developed. However, we understand 

that multiple technological and clinical 

care standard changes associated with 

EHR technology may result in the need 

to consider changes to the objectives 

and measures of meaningful use under 

the EHR Incentive Programs. 

Accordingly, we note that, as 

circumstances warrant, we would 

consider addressing such changes in 

future rulemaking. 

As shown in Table 2, providers in any 

given year may be participating in 1 of 

3 different stages of the EHR Incentive 

Programs in addition to other CMS 

quality reporting programs using 

certified health IT such as PQRS and 

Hospital IQR. Through listening 

sessions, correspondence, and public 

comment forums, providers expressed 

frustration regarding the competing 

reporting requirements of multiple CMS 

programs, and the overall challenge of 

planning and reporting on the complex 

and numerous meaningful use 

requirements, including the need to 

manage changing processes, workflows, 

and reporting systems. In addition, 

group practices with EPs in different 

stages of meaningful use have to 

simultaneously support multiple stages 

of the program in order to demonstrate 

meaningful use for each EP. Meanwhile, 

if the current 3-stage framework 

continues, HHS and state systems 

would be required to support all 3 

stages of the EHR Incentive Programs in 

perpetuity with extensive 

implementation of complex processes to 

accept submissions, analyze data, and 

coordinate systems. 

Providers have expressed ongoing 

concern that the EHR Incentive 

Programs are complicated, not focused 

on clinical reality and workflow, and 

stifling to innovation in health IT 

development. Specifically, providers 

have expressed concerns about the 

number of Stage 1 and 2 objectives and 

measures becoming obsolete or lacking 

any link to improving outcomes. In 

addition, providers have expressed 

concern that continued focus on Stage 1 

measures impedes current and potential 

future innovation in advanced 

utilization of health information 

technology. Providers worry that Stage 3 

of meaningful use would exacerbate 

these existing concerns. 

The certified EHR technology 

requirements within the EHR Incentive 

Programs and included in ONC’s Health 

IT Certification Program have resulted 

in considerable increases in certified 

EHR technology adoption among 

providers and are paving the way for 

more comprehensive, patient-centered 

care across the care continuum. We 

recognize that while these 

advancements have been beneficial 

there are concerns, as stated previously, 

that require careful examination to 

ensure the sustainability and efficacy of 

the program going forward—as HHS 

moves to further encourage new uses of 

health IT and support the developing 

health IT infrastructure beyond the 

strides already made. Therefore, we seek 

to set a new foundation for this evolving 

program by proposing a number of 

changes to meaningful use. First, we 

propose a definition of meaningful use 

that would apply beginning in 2017. 

This definition of meaningful use, 

although referred to as ‘‘Stage 3’’, would 

be the only definition for the Medicare 

and Medicaid EHR Incentive Programs, 

and would incorporate certain 

requirements and aspects of Stages 1 

and 2. Beginning with 2018, we propose 

to require all EPs, eligible hospitals, and 

CAHs, regardless of their prior 

participation in the EHR Incentive 

Program, to satisfy the requirements, 

objectives, and measures of Stage 3. 

However, for 2017, we propose that 

Stage 3 would be optional for providers. 

This option would allow for a provider 

to move on to Stage 3 in 2017 or remain 

at Stage 2, or for some providers to 

remain at Stage 1, depending on their 

participation timeline. For example, 

under this proposal, a provider in Stage 

2 in 2016 could choose to remain in 

Stage 2 in 2017 or progress to Stage 3. 

In contrast to our rulemaking in 2014 to 

accommodate the use of multiple 

Editions to meet the definitions of 

CEHRT during the EHR reporting 

periods in that year, this policy is based 

on the provider selection of the 

objectives and measures for their 

demonstration of meaningful use in 

2017. Both the EHR technology certified 

to the 2014 Edition and the EHR 

technology certified to the 2015 Edition 

will support attestations for Stage 1 or 

Stage 2 in 2017. In addition, the 

development and certification process 

for EHR technology products is not 

dependent on this selection by 

individual providers. Therefore, we do 

not expect that this policy would affect 

the availability of EHR technology 

certified to the 2015 Edition in 2017 or 

the ability of an individual provider to 

implement EHR technology certified to 

the 2015 Edition during the year 

regardless of which stage they choose 

for their EHR reporting period in 2017. 

Therefore, we are proposing in section 

II.A.2.b. that all providers would be 

required to use EHR technology certified 

to the 2015 Edition for a full calendar 

year for the EHR reporting period in 

2018. The revised timeline based on 

these proposals is outlined in Table 3. 

TABLE 3—STAGE OF MEANINGFUL USE CRITERIA BY FIRST YEAR

First year as a 

meaningful EHR user 

Stage of meaningful use 

2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 

2021 

and future 

years 

2011 ......................................... 1 1 1 * 2 2 2 2 or 3 3 3 3 3 

2012 ......................................... ............ 1 1 * 2 2 2 2 or 3 3 3 3 3 

2013 ......................................... ............ ............ 1 1 2 2 2 or 3 3 3 3 3 

2014 ......................................... ............ ............ ............ 1 1 2 2 or 3 3 3 3 3 

2015 ......................................... ............ ............ ............ ............ 1 1 1, 2 or 3 3 3 3 3 

2016 ......................................... ............ ............ ............ ............ ............ 1 1, 2 or 3 3 3 3 3 

2017 ......................................... ............ ............ ............ ............ ............ ............ 1, 2 or 3 3 3 3 3 

2018 and future years .............. ............ ............ ............ ............ ............ ............ .............. 3 3 3 3 

* Please note, a provider scheduled to participate in Stage 2 in 2014, who instead elected to demonstrate stage 1 because of delays in availability of EHR technology certified to the 2014 Edition, is still considered a stage 2 provider in 2014 despite the alternate demonstration of meaningful use. In 2015, all such providers are considered to be participating in their second year of Stage 2 of meaningful use. 

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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 

incentive payments may be received, 

and the last year to initiate the program 

and receive an incentive payment. 

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 3. The 

applicable payment years and the 

incentive payments available for each 

program are discussed in the Stage 1 

final rule (75 FR 44318 through 44320). 

Although Table 3 outlines a provider’s 

progression through the stages of 

meaningful use, it does not necessarily 

reflect the relation to incentive 

payments in the Medicare or Medicaid 

EHR Incentive Programs. We note that 

some providers may not ever qualify to 

receive an incentive payment depending 

on, among other factors, when and 

whether they successfully demonstrate 

meaningful use in the EHR Incentive 

Programs. We intend for the timeline in 

Table 3 to also apply to those EPs, 

eligible hospitals, and CAHs that never 

receive an incentive payment under the 

EHR Incentive Programs. 

We are further proposing that Stage 3 

would adopt a simplified reporting 

structure on a focused set of objectives 

and associated measures to replace all 

criteria under Stages 1 and 2. 

Specifically, we are proposing criteria 

for meaningful use for EPs, eligible 

hospitals, and CAHs (optional in 2017 

and mandatory beginning in 2018), 

regardless of a provider’s prior 

participation in the Medicare and 

Medicaid EHR Incentive Programs, as 

described in detail in section II.A.1.c. of 

this proposed rule. We believe that a 

single set of objectives would reduce 

provider burden and allow for greater 

focus on improving outcomes, 

enhancing interoperability, and 

increasing patient engagement. In 

addition, with all providers 

participating at the same level, the 

impact of the scale of participation 

helps to support growth in health 

information exchange and patient 

engagement infrastructure, as more 

providers participate the ease of 

participation increases. Finally, the 

associated measures proposed for Stage 

3 in this proposed rule would use 

advanced EHR functionality and ITbased processes. The requirements, 

objectives, and measures are outlined 

further in sections II.A.1.c.(2). of this 

proposed rule. In order to maintain 

clarity in relation to the various rules 

and stages, provisions outlined in the 

Stage 1 or Stage 2 final rules, and 

proposals under this Stage 3 proposed 

rule, we will maintain the ‘‘Stage’’ 

designation in order to indicate the rule 

that contains the provision. The 

requirements, objectives, and measures 

proposed as part of this proposed 

definition of meaningful use would be 

referred to as ‘‘Stage 3’’. 

We welcome public comment on 

these proposals. 

(b) EHR Reporting Period 

In the Stage 1 and Stage 2 final rules, 

we established that the EHR reporting 

period for eligible hospitals and CAHs 

is based on the federal fiscal year 

(October 1 through September 30). This 

fiscal year EHR reporting period 

originally was designed to support 

coordination between program 

implementation and CMS payment 

systems following the development of 

the EHR Incentive Programs in 2010 to 

allow for efficient payment of incentives 

for eligible hospitals and CAHs. 

However, as the EHR Incentive Program 

evolved, we found the fiscal year EHR 

reporting period resulted in varying 

reporting timelines between provider 

types (for example, the EHR reporting 

period for EPs is based on the calendar 

year) and a shortened timeline for 

system developers to meet hospital and 

CAH technology requirements. 

Enhanced coordination between CMS 

programs and other system 

implementation changes have 

subsequently made it unnecessary to 

maintain a reporting timeframe for 

eligible hospitals and CAHs based on 

the federal fiscal year. Therefore, we are 

proposing changes to the EHR reporting 

period beginning with the EHR 

reporting period in 2017 in order to do 

all of the following: 

• Simplify reporting for providers, 

especially groups and diverse systems. 

• Support further alignment of CMS 

quality reporting programs using 

certified health IT such as Hospital IQR 

and PQRS. 

• Simplify HHS system requirements 

for data capture. 

• Provide for greater flexibility, stress 

testing, and Quality Assurance (QA) of 

systems before deployment. 

In the FY 2015 IPPS final rule (79 FR 

49853 through 50449), we aligned the 

reporting and submission timelines for 

CQMs for the Medicare EHR Incentive 

Programs for eligible hospitals and 

CAHs with the reporting and 

submission timelines for the Hospital 

IQR Program on a calendar year basis. 

This was designed to allow for better 

alignment between these programs in 

light of the directive in section 

1886(n)(3)(B)(iii) of the Act to avoid 

redundant or duplicative reporting. 

Calendar year reporting on quality data 

for hospitals allows for greater 

efficiency in measure development, the 

electronic specification of measures, 

and the update and deployment of 

measure logic and value sets for 

electronic clinical quality measures. The 

FY 2014 IPPS final rule (78 FR 50904) 

clarified that eligible hospitals and 

CAHs demonstrating meaningful use for 

the first time in FY 2014 and reporting 

on CQMs electronically must report on 

a 3-month quarter in FY 2014, rather 

than on a continuous 90-day period. 

Such changes not only better align 

program reporting but also allow for 

better data integrity as previously 

discussed in the Stage 2 final rule (77 

FR 53974 through 53975) and further 

discussed in section II.B.1.b. of this 

proposed rule. 

(i) Calendar Year Reporting 

We are proposing to change the 

definitions of ‘‘EHR reporting period’’ 

and ‘‘EHR reporting period for a 

payment adjustment year’’ under § 495.4 

for EPs, eligible hospitals, and CAHs 

such that the EHR reporting period 

would be one full calendar year, with a 

limited exception under the Medicaid 

EHR Incentive Program for providers 

demonstrating meaningful use for the 

first time as discussed later in this 

section and in section II.A.2.b. of this 

proposed rule. This would allow for the 

full alignment of the EHR reporting 

timeline for the meaningful use 

objectives and associated measures and 

the CQMs, and align the timing of 

reporting by EPs, eligible hospitals, and 

CAHs. We propose this change would 

apply beginning in CY 2017. For 

example, for the incentive payments for 

the 2017 payment year, the EHR 

reporting period for EPs, eligible 

hospitals, and CAHs would be the full 

2017 calendar year. We note that the 

incentive payments under Medicare FFS 

and Medicare Advantage (MA) (sections 

1848(o), 1886(n), 1814(l)(3), 1853(l) and 

(m) of the Act) will end before 2017. 

However, under this proposed change, 

EPs and eligible hospitals that seek to 

qualify for an incentive payment under 

Medicaid would have a full calendar 

year EHR reporting period if they are 

not demonstrating meaningful use for 

the first time. For the payment 

adjustments under Medicare, we discuss 

the timing of the EHR reporting period 

in relation to the payment adjustment 

year in section II.D.2. of this proposed 

rule. 

This proposal would mean that 

eligible hospitals and CAHs would have 

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a reporting gap for the objectives and 

measures of meaningful use consisting 

of the 3-month quarter from October 1, 

2016 through December 31, 2016. 

Depending on future rulemaking, 

eligible hospitals and CAHs may still be 

required to report on CQMs over this 

time. The next EHR reporting period for 

eligible hospitals and CAHs to collect 

data on the objectives and measures of 

meaningful use would then begin on 

January 1, 2017 and end on December 

31, 2017. Eligible hospitals and CAHs 

would then report on a full calendar 

year basis from that point forward. 

(ii) Eliminate 90-Day EHR Reporting 

Period 

We are further proposing to eliminate 

the 90-day EHR reporting period for 

new meaningful EHR users beginning in 

2017, with a limited exception for 

Medicaid EPs and eligible hospitals 

demonstrating meaningful use for the 

first time. This would allow for a single 

EHR reporting period of a full calendar 

year for all providers across all settings. 

Specifically, we propose to eliminate 

the EHR reporting period of any 

continuous 90 days for EPs, eligible 

hospitals, and CAHs that are 

demonstrating meaningful use for the 

first time. Those providers instead 

would have an EHR reporting period of 

a full calendar year, as described 

previously. However, as discussed in 

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

we propose to maintain the 90-day EHR 

reporting period for a provider’s first 

payment year based on meaningful use 

for EPs and eligible hospitals 

participating in the Medicaid EHR 

Incentive Program. We propose 

corresponding revisions to the 

definitions of ‘‘EHR reporting period’’ 

and ‘‘EHR reporting period for a 

payment adjustment year’’ under 

§ 495.4. We propose these changes 

would apply beginning in CY 2017. 

As stated previously, all providers 

would attest based on a single EHR 

reporting period consisting of one full 

calendar year for the applicable 

objectives and measures of meaningful 

use in 2017 and subsequent years. These 

providers would submit their data in the 

2 months following the close of the EHR 

reporting period. For further 

information on the submission methods, 

see section II.D.9.b. of this proposed 

rule. 

We welcome public comment on 

these proposals. 

(iii) State Flexibility for Stage 3 of 

Meaningful Use 

Consistent with our approach under 

both Stage 1 and 2, we propose to 

continue to offer states flexibility under 

the Medicaid EHR Incentive Program in 

Stage 3 by adding a new provision at 

§ 495.316(d)(2)(iii) subject to the same 

conditions and standards as the Stage 2 

flexibility policy. Under Stage 3, state 

flexibility would apply only with 

respect to the public health and clinical 

data registry reporting objective 

outlined under section II.A.1.c.(1).(b).(i). 

of this proposed rule. 

For Stage 3 of meaningful use, we 

would continue to allow states to 

specify the means of transmission of the 

data and otherwise change the public 

health agency reporting objective as 

long as it does not require functionality 

greater than what is required for Stage 

3 and included in the 2015 Edition 

proposed rule elsewhere in this issue of 

the Federal Register. 

We welcome comment on this 

proposal. 

(2) Criteria for Meaningful Use Stage 3 

In the Stage 1 and Stage 2 final rules, 

meaningful use included the concept of 

a core and a menu set of objectives. 

Each objective had associated measures 

that a provider needed to meet as part 

of demonstrating meaningful use of 

CEHRT. In Stage 2 of meaningful use, 

we also combined some of the objectives 

of Stage 1 and incorporated them into 

objectives for Stage 2. For example, we 

combined the objectives of maintaining 

an up-to-date problem list, active 

medication list, and active medication 

allergy list with the objective of 

providing a summary of care record for 

each transition of care or referral 

through required fields in the summary 

of care document (77 FR 53990 through 

53991 and 77 FR 54013 through 54016). 

We did this to allow for the more 

advanced use of EHR technology 

functions to support clinical processes, 

and to eliminate the need for providers 

to individually report on measures that 

were often already incorporated in 

workflows and for which many 

providers were already meeting the 

threshold (known as ‘‘topping out’’). In 

the Stage 2 final rule (77 FR 53973), we 

signaled that the Stage 2 core and menu 

objectives would all be included in the 

Stage 3 proposal for meaningful use. 

Since the publication of the Stage 2 

final rule, we have reviewed meaningful 

use performance from both a qualitative 

and quantitative perspective including 

analyzing performance rates, reviewing 

CEHRT functionalities and standards, 

and considering information gained by 

engaging with providers through 

listening sessions, correspondence, and 

open forums like the HIT Policy 

Committee. The data support a number 

of key points for consideration: 

• Providers are performing higher 

than the thresholds for some of the 

meaningful use measures using some 

EHR functionalities that—prior to the 

Stage 1 and Stage 2 final rules—were 

not common place (such as the 

maintenance of problem lists). 

• Providers in different specialties 

and settings implemented CEHRT and 

met objectives in different ways. 

• Providers express support for 

reducing the reporting burden on 

measures that have ‘‘topped out.’’ 

• Providers expressed support for 

advanced functionality that would offer 

value to providers and patients. 

• Providers expressed support for 

flexibility regarding how objectives are 

implemented in their practice settings. 

• Providers in health systems and 

large group practices expressed 

frustration about the reporting burden of 

having to compile multiple reports 

spanning multiple stages and objectives. 

Since the EHR Incentive Programs 

began in 2011, stakeholder associations 

and providers have requested that we 

consider changes to the number of 

objectives and measures that providers 

must meet to demonstrate meaningful 

use of certified EHR technology under 

the EHR Incentive Programs. These 

recommendations also extended to 

considerations for the structure of Stage 

3 of meaningful use. Many of these 

recommendations include allowing a 

provider to fail any two objectives (in 

effect making all objectives ‘‘menu’’ 

objectives) and still meet meaningful 

use, or to allow providers to receive an 

incentive payment or avoid a downward 

payment adjustment based on varied 

percentages of performance, and 

removing all measure thresholds. We 

have reviewed these recommendations 

and have declined to follow this course 

for a number of reasons. 

First, the statute specifically requires 

the Secretary to seek to improve the use 

of EHR and health care quality over time 

by requiring more stringent measures of 

meaningful use (see, for example, 

section 1848(o)(2)(A)(iii) of the Act). 

This is one reason why we established 

stages of meaningful use to move 

providers along a progression from 

adoption to advanced use of certified 

EHR technology. Therefore, we intend 

to continue to use measure thresholds 

that may increase over time, and to 

incorporate advanced use functions of 

certified EHR technology into 

meaningful use objectives and 

measures. 

Second, there are certain objectives 

and measures which capture policies 

specifically required by the statute as 

core goals of meaningful use of certified 

EHR technology, such as electronic 

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prescribing for EPs, health information 

exchange, and clinical quality 

measurement (see sections 1848(o)(2)(A) 

and 1886(n)(3)(A) of the Act). Specific 

to the health information exchange, the 

statute requires certified EHR 

technology connected in a manner that 

provides for the electronic exchange of 

health information to improve the 

quality of health care, such as 

promoting care coordination. 

Further, the statute requires that the 

certified EHR technology which 

providers must use shall be a ‘‘qualified 

EHR’’ as defined in section 3000(13) of 

the Public Health Service Act as an 

electronic record of health-related 

information on an individual that 

includes patient demographic and 

clinical health information, such as 

medical history and problem lists; and 

has the capacity to— 

• Provide clinical decision support; 

• Support physician order entry; 

• Capture and query information 

relevant to health care quality; and 

• Exchange electronic health 

information with, and integrate such 

information from, other sources (see 

section 1848(o)(4) of the Act). 

The objectives that address these 

requirements are integral to the 

foundational goals of the program, 

which would be undermined if 

providers were allowed to fail to meet 

these objectives and still be considered 

meaningful EHR users. For these 

reasons, we intend to continue to 

require providers to meet the objectives 

and measures of meaningful use as 

required for the program, rather than 

allowing providers to fail any two 

objectives of their choice or making all 

objectives menu objectives. 

Finally, while we understand 

providers are seeking to reduce the 

overall burden of reporting, we do not 

believe these recommendations 

accomplish that goal. Adding all 

objectives and measures to the menu set 

and allowing for varying degrees of 

participation may add complexity for 

the individual provider seeking to 

determine how they can meet the 

requirements and demonstrate 

meaningful use of certified EHR 

technology. We instead are proposing 

(as discussed in sections II.A.1. and II.B. 

of this proposed rule) to reduce provider 

burden and simplify the program by 

aligning reporting periods and CQM 

reporting. In addition, the statute 

provides that in selecting measures for 

the EHR Incentive Program, the 

Secretary shall seek to avoid redundant 

or duplicative reporting otherwise 

required, including reporting under the 

PQRS and Hospital IQR Program (see 

sections 1848(o)(2)(B)(iii) and 

1886(n)(3)(B)(iii) of the Act). Although 

the statute refers to redundant or 

duplicative reporting in the context of 

other CMS quality reporting programs, 

we believe it is also useful and 

appropriate to consider whether there 

are redundant or duplicative aspects of 

the objectives and measures of Stages 1 

and 2 of meaningful use as we develop 

policies for Stage 3. 

To that end, we have analyzed the 

objectives and measures of meaningful 

use in Stage 1 and Stage 2 of the 

program to determine where measures 

are redundant, duplicative, or have 

‘‘topped out.’’ ‘‘Topped out’’ is the term 

used to describe measures that have 

achieved widespread adoption at a high 

rate of performance and no longer 

represent a basis upon which provider 

performance may be differentiated. We 

considered redundant objectives and 

measures to include those where a 

viable health IT-based solution may 

replace paper-based actions, such as the 

Stage 2 Clinical Summary objective (77 

FR 54001 and 54002). We considered 

duplicative objectives and measures to 

include those where some aspect is also 

captured in the course of meeting 

another objective or measure, such as 

recording vital signs which is also 

required as part of the summary of care 

document under the Stage 2 Summary 

of Care objective (77 FR 54013 through 

54021). Finally, measures which have 

‘‘topped out’’ do not provide a 

meaningful gain in the effort to improve 

the use of EHR and health care quality 

over time by requiring more stringent 

measures of meaningful use as directed 

in the statute (see section 

1848(o)(2)(A)(iii) of the Act). For further 

discussion of ‘‘topped out’’ measures, 

we direct readers to section II.A.2.a. of 

this proposed rule. 

Therefore, our proposals for Stage 3 

would continue the precedent of 

focusing on the advanced use of 

certified EHR technology. They would 

reduce the reporting burden; eliminate 

measures that are now redundant, 

duplicative, and ‘‘topped out’’; create a 

single set of objectives for all providers 

with limited variation between EPs, 

eligible hospitals, and CAHs as 

necessary; and provide flexibility within 

the objectives to allow providers to 

focus on implementations that support 

their practice. 

(a) Topped Out Objectives and Measures 

In other contexts and CMS programs, 

CQMs are regularly evaluated to 

determine whether they have ‘‘topped 

out,’’ which means generally that 

measure performance among providers 

is so high and unvarying that 

meaningful distinctions and 

improvements in performance can no 

longer be made. Examples of this type 

of evaluation are found in the Hospital 

Inpatient Quality Reporting (IQR) 

program, the Hospital-Value Based 

Purchasing (HVBP) program, the EndStage Renal Disease (ESRD) Quality 

Initiative, and within the National 

Quality Forum (NQF) endorsement and 

maintenance process for CQMs. We 

believe that quality measures, once 

‘‘topped-out,’’ represent care standards 

that have been widely adopted. We 

believe such measures should be 

considered for removal from program 

reporting because their associated 

reporting burden may outweigh the 

value of the quality information they 

provide and because, in some cases, the 

inclusion of these measures may impact 

the ability to differentiate among 

provider performance as a whole for 

programs which use baseline and 

benchmarking based on measure 

performance scores. Therefore, 

measures are regularly subject to an 

evaluation process to identify their 

continued efficacy. This evaluation 

process is used to determine whether a 

measure is ‘‘topped out’’ and, if so, 

whether that measure should be 

removed from program reporting 

requirements. We note that both the 

identification and the determination of 

a measure are part of the process as a 

measure may be identified as topped 

out, but still be determined useful as a 

measure for a specific program because 

of other factors that merit continued use 

of the measure. 

While the EHR Incentive Program 

does not use a benchmarking system to 

rate the overall and relative performance 

of providers as part of the definitions of 

meaningful use; we are proposing to 

adopt an approach to evaluate whether 

objectives and measures have become 

‘‘topped out’’ and, if so, whether a 

particular objective or measure should 

be considered for removal from 

reporting requirements. We propose to 

apply the following two criteria, which 

are similar to the criteria used in the 

Hospital IQR and HVBP Programs (79 

FR 50203): 1—Statistically 

indistinguishable performance at the 

75th and 99th percentile, and 2— 

performance distribution curves at the 

25th, 50th, and 75th percentiles as 

compared to the required measure 

threshold. 

An example of a current Stage 1 

objective which would be considered 

‘‘topped out’’ under this approach is the 

objective to record demographics (75 FR 

44340 through 44343). For the record 

demographics objective, we reviewed 

performance data submitted by 

providers through attestation and 

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1 Data may be found on the CMS Web site data 

and program reports page: https://www.cms.gov/

Regulations-and-Guidance/Legislation/

EHRIncentivePrograms/DataAndReports.html. 

determined that across all years of 

participation, the 75th percentile is 

performing at 99.8 percent with the 99th 

percentile performing at 100 percent. In 

addition, the 25th, 50th, and 75th 

percentiles are all performing with 

minimal variance and significantly 

higher than the measure threshold of 50 

percent, with performance rates at 97 

percent, 99 percent, and 100 percent 

respectively for eligible hospitals and 92 

percent, 98 percent and 100 percent 

respectively for EPs in Stage 1.1 For 

more information on the performance 

data, please see the EHR Incentive 

Programs Objective and Measure 

Performance Report by Percentile 

available at http://www.cms.gov/

Regulations-and-Guidance/Legislation/

EHRIncentivePrograms/

DataAndReports.html. We further note 

that this particular objective may also be 

considered duplicative as further 

discussed in section II.A.2.c. of this 

proposed rule, as the functionality 

which supports the objective within the 

EHR is also used in other objectives 

such as the objective to provide patientspecific education resources (77 FR 

54011 through 54012) and the Stage 2 

summary of care objective (77 FR 54013 

through 54021). Therefore, this is an 

example of an objective that we 

determined is topped out and may no 

longer provide value as an independent 

objective in the program. 

We welcome public comments on our 

proposed approach for topped out 

objectives and measures. 

(b) Electronic Versus Paper-Based 

Objectives and Measures 

In Stages 1 and 2, we require or allow 

providers the option to include paperbased formats for certain objectives and 

measures. For these objectives and 

measures, providers would print, fax, 

mail, or otherwise produce a paper 

document and manually count these 

actions to include in the measure 

calculation. Examples of these include: 

The provision of a non-electronic 

summary of care document for a 

transition or referral to meet the 

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

for eligible hospitals and CAHs 

at§ 495.6(l)(11)(i): ‘‘The [provider] who 

transitions or refers their patient to 

another setting of care or provider of 

care provides a summary of care record 

for more than 50 percent of transitions 

of care and referrals;’’ and the provision 

of paper-based patient education 

materials measure for at § 495.6(j)(12)(i) 

for EPs and § 495.6(l)(9)(i) requiring: 

‘‘Patient-specific education resources 

identified by Certified EHR Technology 

are provided to patients for more than 

10 percent of all unique patients with 

office visits seen by the EP [or 

discharged from the eligible hospital or 

CAH] during the EHR reporting period.’’ 

Each of these measures may be met 

using a non-electronic format or action, 

and we propose to discontinue this 

policy for Stage 3. We recognize the 

strides that providers have made in the 

use of CEHRT and as we move forward 

in MU, it is appropriate to remove the 

earlier iterations of objectives and 

measures that were designed to support 

beginning EHR use and instead focus on 

objectives that are based solely on 

electronic use of data. This does not 

imply that we do not support the 

continued use of paper-based materials 

in a practice setting. Some patients may 

prefer to receive a paper version of their 

clinical summary or may want to 

receive education items or reminders on 

paper or some other method that is not 

electronic. We strongly recommend that 

providers continue to provide patients 

with visit summaries, patient health 

information, and preventative care 

recommendations in the format that is 

most relevant for each individual 

patient and easiest for that patient to 

access. In some cases, this may include 

the continued use of non-IT-based 

resources. We are simply proposing that 

paper-based formats would not be 

required or allowed for the purposes of 

the objectives and measures for Stage 3 

of meaningful use. We welcome public 

comments on this proposal. 

(c) Advanced EHR Functions 

As discussed in section II.A.1.c.(2).(a). 

of this proposed rule, we are proposing 

to simplify requirements for meaningful 

use through an analysis of existing 

objectives and measures for Stages 1 and 

2 to determine if they are redundant, 

duplicative, or ‘‘topped out’’. We note 

that some of the objectives and 

measures which meet these criteria 

involve EHR functions that are required 

by the statutory definition of ‘‘certified 

EHR technology’’ (see section 1848(o)(4) 

of the Act, which references the 

definition of ‘‘qualified EHR’’ in section 

3000(13) of the Public Health Service 

Act) which a provider must use to 

demonstrate meaningful use. The 

objectives and measures proposed for 

Stage 3 would include uses of these 

functions in a more advanced form. For 

example, patient demographic 

information is included in an electronic 

summary of care document called a 

consolidated clinical document 

architecture (CCDA) provided during a 

transition of care in the Stage 2 

Summary of Care objective and 

measures (77 FR 54013 through 54021), 

which represents a more advanced use 

of the EHR function than in the Stage 1 

and 2 objective to record patient 

demographic information (77 FR 53991 

through 53993). 

We adopted a multi-part approach to 

identify the objectives and measures 

which would be proposed for providers 

to demonstrate meaningful use for Stage 

3. This methodology included the 

analysis mentioned previously of 

existing Stage 1 and 2 objectives and 

measures, and provider performance; a 

review and consideration of the HIT 

Policy Committee recommendations 

(which are publically available for 

review at: http://www.healthit.gov/

facas/health-it-policy-committee/healthit-policy-committee-recommendationsnational-coordinator-health-it); and an 

evaluation of how the potential 

objectives and measures align with the 

foundational goals of the program 

defined in the HITECH Act. 

In the Stage 2 proposed and final 

rules, we often identified the HIT Policy 

Committee recommendations as part of 

our discussion of the specific objectives 

and measures, for example in the Stage 

2 CPOE objective at 77 FR 43985. In this 

proposed rule for Stage 3 of meaningful 

use, although we have considered the 

HIT Policy Committee’s 

recommendations in developing our 

proposed policies, we are not 

referencing the recommendations in 

each individual proposed objective and 

measure as there are multiple factors 

that contribute to the selection of each 

proposed objective and measure. In 

addition, many of the HIT Policy 

Committee recommendations address 

functions and standards that are part of 

the advanced use of certified EHR 

technology captured by one or more 

objectives proposed for Stage 3 of 

meaningful use. For example, the HIT 

Policy Committee has recommended an 

expansion of demographic data 

captured as structured data as well as a 

change to the related standards for use. 

However, this function and standard is 

required for certification of EHR 

technology for meaningful use and it is 

a required field for an electronic 

summary of care document for health 

information exchange. It is also to be 

included in the information accessible 

to a patient within their electronic 

patient record. Therefore, to provide 

clarity for readers, we provide a 

notation within Table 4 to identify 

alignment between the proposed Stage 3 

objectives and measures and the 

recommendations of the HIT Policy 

Committee for Stage 3 of meaningful 

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2The National Quality Strategy: ‘‘HHS National 

Strategy for Quality Improvement in Health Care’’ 

http://www.ahrq.gov/workingforquality/about.htm. 

use. We direct readers to the HIT Policy 

Committee recommendations available 

on HealthIT.gov for further information 

(http://www.healthit.gov/facas/health-itpolicy-committee/health-it-policycommittee-recommendations-nationalcoordinator-health-it). 

As mentioned previously, the statute 

includes certain foundational goals and 

requirements for meaningful use of 

certified EHR technology and the 

functions of that technology. Therefore, 

after review of the existing Stage 1 and 

Stage 2 objectives and measures of 

meaningful use, the recommendations 

of the HIT Policy Committee, and the 

foundational goals and requirements 

under the HITECH Act; we have 

identified eight key policy areas which 

represent the advanced use of EHR 

technology and align with the program’s 

foundational goals and overall national 

health care improvement goals, such as 

those found in the CMS National 

Quality Strategy.2 These eight policy 

areas provide the basis for the proposed 

objectives and measures for Stage 3 of 

meaningful use. They are included in 

Table 4 as follows: 

TABLE 4—OBJECTIVES AND MEASURES FOR MEANINGFUL USE IN 2017 AND SUBSEQUENT YEARS

Program goal/objective Delivery system reform goal alignment 

Protect Patient Health Information ........................................................... Foundational to Meaningful Use and Certified EHR Technology *. 

Recommended by HIT Policy Committee. 

Electronic Prescribing (eRx) ..................................................................... Foundational to Meaningful Use. 

National Quality Strategy Alignment. 

Clinical Decision Support (CDS) .............................................................. Foundational to Certified EHR Technology. 

Recommended by HIT Policy Committee. 

National Quality Strategy Alignment. 

Computerized Provider Order Entry (CPOE) ........................................... Foundational to Certified EHR Technology. 

National Quality Strategy Alignment. 

Patient Electronic Access to Health Information ...................................... Recommended by HIT Policy Committee. 

National Quality Strategy Alignment. 

Coordination of Care through Patient Engagement ................................. Recommended by HIT Policy Committee. 

National Quality Strategy Alignment. 

Health Information Exchange (HIE) ......................................................... Foundational to Meaningful Use and Certified EHR Technology. 

Recommended by HIT Policy Committee. 

National Quality Strategy Alignment. 

Public Health and Clinical Data Registry Reporting ................................ Recommended by HIT Policy Committee. 

National Quality Strategy Alignment. 

* See, for example, sections 1848(o)(2) and (4) of the Act. 

These objectives build on the measures 

and EHR functionalities from the Stage 

1 final rule and the Stage 2 final rule to 

advance the core functions of EHRs in 

a clinically relevant way that benefits 

providers and patients. 

Under this proposal, which would 

apply to Stage 3 of meaningful use in 

2017 and subsequent years, providers 

must successfully attest to these eight 

objectives and the associated measures 

(or meet the exclusion criteria for the 

applicable measure). As mentioned 

previously, the statute requires the 

Secretary to seek to improve the use of 

EHR and health care quality over time 

by requiring more stringent measures of 

meaningful use (see section 

1848(o)(2)(A)(iii) of the Act). While we 

are proposing to simplify the program 

by removing topped-out, redundant, and 

duplicative measures and aligning 

reporting periods for providers; we are 

maintaining the push to improve the use 

of EHRs over time through these eight 

objectives and the associated measures 

proposed for Stage 3 of meaningful use. 

These proposed objectives and measures 

include advanced EHR functions, use a 

wide range of structured standards in 

CEHRT, employ increased thresholds 

over similar Stage 1 and 2 measures, 

support more complex clinical and care 

coordination processes, and require 

enhanced care coordination through 

patient engagement through a flexibility 

structure of active engagement 

measures. 

These proposed objectives and their 

associated measures are further 

discussed in section II.A.1.(c).(2). of this 

proposed rule. CMS and ONC will 

continue to monitor and review 

performance on the objectives and 

measures finalized for Stage 3 to 

continue to evaluate them for rigor and 

efficacy and, if necessary, propose 

changes in future rulemaking. 

(d) Flexibility Within Meaningful Use 

Objectives and Measures 

We are proposing to incorporate 

flexibility within certain objectives 

proposed for Stage 3 for providers to 

choose the measures most relevant to 

their unique practice setting. This 

means that as part of successfully 

demonstrating meaningful use, 

providers would be required to attest to 

the results for the numerators and 

denominators of all measures associated 

with an objective; however, a provider 

would only need to meet the thresholds 

for two of the three associated measures. 

The proposed Stage 3 objectives 

including flexible measure options are 

as follows: 

• Coordination of Care through 

Patient Engagement—Providers must 

meet the thresholds of two of three 

measures and must attest to the 

numerators and denominators of all 

three measures. 

• Health Information Exchange— 

Providers must meet the thresholds of 

two of three measures and must attest to 

the numerators and denominators of all 

three measures. 

• Public Health Reporting—EPs must 

report on three measures and eligible 

hospitals and CAHs must report on four 

measures. 

We propose that if a provider meets 

the exclusion criteria for a particular 

measure within an objective which 

allows providers to meet the thresholds 

for two of three measures (namely, the 

Coordination of Care through Patient 

Engagement objective and the Health 

Information Exchange objective), the 

provider may exclude the measure and 

must meet the thresholds of the 

remaining two measures to meet the 

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objective. If a provider meets the 

exclusion criteria for two measures for 

such an objective, the provider may 

exclude those measures and must meet 

the threshold of the remaining measure 

to meet the objective. If a provider meets 

the exclusion criteria for all three 

measures for such an objective, the 

provider may exclude those measures 

and would be considered to have met 

the objective. 

We discuss the proposed policy for 

exclusions for the public health 

reporting objective as well as the 

exclusion criteria in further detail 

within the individual objectives and 

measures in section II.A.1.(c).(2). of this 

proposed rule. 

(e) EPs Practicing in Multiple Practices/ 

Locations 

For Stage 3, we propose to maintain 

the policy from the Stage 2 final rule (77 

FR 53981) which states that to be a 

meaningful user, an EP must have 50 

percent or more of his or her outpatient 

encounters during the EHR reporting 

period at a practice/location or 

practices/locations equipped with 

CEHRT. An EP who does not conduct at 

least 50 percent of their patient 

encounters in any one practice/location 

would have to meet the 50 percent 

threshold through a combination of 

practices/locations equipped with 

CEHRT. For example, if the EP practices 

at a federally qualified health center 

(FQHC) and within his or her individual 

practice at two different locations, we 

would include in our review all three of 

these locations, and CEHRT would have 

to be available at one location or a 

combination of locations where the EP 

has 50 percent or more of his or her 

patient encounters. If CEHRT is only 

available at one location, then only 

encounters at this location would be 

included in meaningful use assuming 

this one location represents 50 percent 

or more of the EP’s patient encounters. 

If CEHRT is available at multiple 

locations that collectively represent 50 

percent or more of the EP’s patient 

encounters, then all encounters from 

those locations would be included in 

meaningful use. In the Stage 2 final rule 

at (77 FR 53981), we defined patient 

encounter as any encounter where a 

medical treatment is provided 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. 

In addition, in the Stage 2 final rule 

at (77 FR 53981) we defined a practice/ 

location as equipped with CEHRT if the 

record of the patient encounter that 

occurs at that practice/location is 

created and maintained in CEHRT. This 

can be accomplished in the following 

three ways: CEHRT could be 

permanently installed at the practice/

location, the EP could bring CEHRT to 

the practice/location on a portable 

computing device, or the EP could 

access CEHRT remotely using 

computing devices at the practice/

location. We propose to maintain these 

definitions for Stage 3. 

(f) Denominators 

The objectives for Stage 3 of 

meaningful use include percentagebased measures wherever possible. In 

the Stage 2 final rule, we included a 

discussion of the denominators used for 

the program that included the use of one 

of four denominators for each of the 

measures associated with the 

meaningful use objectives outlined in 

the Stage 2 final rule at 77 FR 53982 for 

EPs and 77 FR 53983 for eligible 

hospitals and CAHs. We focused on 

denominators because the action that 

moves something from the denominator 

to the numerator requires the use of 

CEHRT by the provider. For Stage 3 we 

refer readers to each of the proposed 

objectives and measures for Stage 3 for 

the specific calculation of each 

denominator for each measure. Here, we 

simply outline the general proposals for 

determining the scope of the measure 

denominators. 

For EPs, the references used to define 

the scope of the potential denominators 

for measures include the following: 

• Unique patients seen by the EP 

during the EHR reporting period. The 

scope for this calculation may be 

limited to only those patients whose 

records are maintained in the EHR for 

the denominator of the measures for 

objectives other than those referencing 

‘‘unique patients’’ as previously 

established in the Stage 2 final rule at 

(77 FR 53981). We propose to maintain 

the policy that EPs who practice at 

multiple locations or switch CEHRT 

during the EHR reporting period may 

determine for themselves the method for 

counting unique patients in the 

denominators to count unique patient 

across all locations equipped with 

different CEHRT, or to count at each 

location equipped with CEHRT. In cases 

where a provider switches CEHRT 

products at a single location during the 

EHR reporting period, they also have the 

flexibility to count a patient as unique 

on each side of the switch and not 

across it. EPs in these scenarios must 

choose one of these methods for 

counting unique patients and apply it 

consistently throughout the entire EHR 

reporting period. 

A patient is seen by the EP when the 

EP has a real time physical encounter 

with the patient in which they render 

any service to the patient. We also 

consider a patient seen through 

telehealth as a patient ‘‘seen by the EP’’ 

(telehealth may include the commonly 

known telemedicine as well as 

telepsychiatry, telenursing, and other 

diverse forms of technology-assisted 

health care). However, in cases where 

the EP and the patient do not have a real 

time physical or telehealth encounter, 

but the EP renders a consultative service 

for the patient, such as reading an EKG, 

virtual visits, or asynchronous 

telehealth, the EP may choose whether 

to include the patient in the 

denominator as ‘‘seen by the EP.’’ This 

is necessary so that these providers can 

avoid reporting a zero in the 

denominator and be able to satisfy 

meaningful use. However, we stress that 

once providers choose, they must 

maintain that denominator choice for 

the entire EHR reporting period and for 

all relevant meaningful use measures. 

• Office visits. The denominators of 

the measures that reference ‘‘office 

visits’’ may be limited to only those 

patients whose records are maintained 

using CEHRT. An office visit is defined 

as any billable visit that includes the 

following: 

++ Concurrent care or transfer of care 

visits, 

++ Consultant visits, or 

++ Prolonged physician service 

without direct, face-to-face patient 

contact (for example, telehealth). 

• All medication, laboratory, and 

diagnostic imaging orders created 

during the reporting period 

• Transitions of care and referrals 

including at least— 

++ When the EP is the recipient of the 

transition or referral, the first encounter 

with a new patient and encounters with 

existing patients where a summary of 

care record (of any type) is provided to 

the receiving EP; and 

++ When the EP is the initiator of the 

transition or referral, transitions and 

referrals ordered by the EP. 

Transitions of care are the movement 

of a patient from one setting of care to 

another. Referrals are cases where one 

provider refers a patient to another, but 

the referring provider maintains their 

care of the patient as well. For the 

purposes of distinguishing settings of 

care in determining the movement of a 

patient, we propose that a transition or 

referral may take place when a patient 

is transitioned or referred between 

providers with different billing 

identities, such as a different National 

Provider Identifier (NPI) or hospital 

CMS Certification Number (CCN). We 

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also propose that in the cases where a 

provider has a patient who seeks out 

and receives care from another provider 

without a prior referral, the first 

provider may include that transition as 

a referral if the patient subsequently 

identifies the other provider of care. 

For further explanation of the terms 

‘‘unique patient,’’ ‘‘seen by the EP,’’ 

‘‘office visit,’’ ‘‘transitions of care,’’ and 

‘‘referrals,’’ we refer readers to the 

discussion at 77 FR 53982 through 

53983. For eligible hospitals and CAHs, 

the references used to define the scope 

of the potential denominators for 

measures include the following: 

• Unique patients admitted to the 

eligible hospital’s or CAH’s inpatient or 

emergency department during the EHR 

reporting period. 

• All medication, laboratory, and 

diagnostic imaging orders created 

during the reporting period. 

• Transitions of care and referrals 

including at least— 

++ When the hospital is the recipient 

of the transition or referral: all 

admissions to the inpatient and 

emergency departments; and 

++ When the hospital is the initiator 

of the transition or referral: all 

discharges from the inpatient 

department; and after admissions to the 

emergency department when follow-up 

care is ordered by an authorized 

provider. 

We propose that the explanation of 

the terms ‘‘unique patients,’’ 

‘‘transitions of care,’’ and ‘‘referrals’’ 

stated previously for EPs would also 

apply for eligible hospitals and CAHs, 

and we refer readers to the discussion 

of those terms in the hospital context in 

the Stage 2 final rule (77 FR 53983 and 

53984). We propose for Stage 3 to 

maintain the policy that admissions 

may be calculated using one of two 

methods (the observation services 

method and the all emergency 

department method), as described for 

Stage 2 at 77 FR 53984. The method an 

eligible hospital or CAH chooses must 

be used uniformly across all measures 

for all objectives. 

We reiterate that all discharges from 

an inpatient setting are considered a 

transition of care. We further propose 

for transitions from an emergency 

department, that eligible hospitals and 

CAHs must count any discharge where 

follow up care is ordered by an 

authorized provider regardless of the 

completeness of information available 

on the receiving provider. The eligible 

hospital or CAH should determine an 

internal policy applicable for the 

identification and capture of a patient’s 

primary care provider or other relevant 

care team members for the purposes of 

ordering potential follow-up care. This 

will allow eligible hospitals and CAHs 

to better differentiate between 

discharges where care is ordered and 

discharges to home where no follow up 

care is ordered. 

(g) Patient-Authorized Representatives 

In the Stage 3 Coordination of Care 

through Patient Engagement objective 

and the Patient Electronic Access 

objective outlined in section 

II.A.1.c.(2).(i). of this proposed rule, we 

propose the inclusion of patientauthorized representatives in the 

numerators as equivalent to the 

inclusion of the patient. We recognize 

that patients often consult with and rely 

on trusted family members and other 

caregivers to help coordinate care, 

understand health information, and 

make health care decisions. 

Accordingly, as part of these objectives, 

we encourage providers to provide 

access to health information to patientauthorized representatives in 

accordance with all applicable laws. We 

expect that patient-authorized 

representatives accessing such 

information under these objectives 

could include a wide variety of sources, 

including caregivers and various family 

members. However, we expect that 

patient-authorized representatives with 

access to such health information will 

always act on the patient’s behalf and in 

the patient’s best interests, and will 

remain free from any potential or actual 

conflict of interest with the patient. We 

further expect that the patientauthorized representatives would have 

the patient’s best interests at heart and 

will act in a manner protective of the 

patient. 

(h) Discussion of the Relationship of 

Meaningful Use to CEHRT 

We propose to continue our policy of 

linking each meaningful use objective to 

the CEHRT definition and to ONCestablished certification criteria. As 

with Stage 1 and Stage 2, EPs, eligible 

hospitals, and CAHs must use 

technology certified to the certification 

criteria in the ONC Health IT 

Certification Program to meet the 

objectives and associated measures for 

Stage 3 of meaningful use. In some 

instances, meaningful use objectives 

and measures may not be directly 

enabled by certification criteria of the 

Health IT Certification Program. For 

example, in e-Rx and public health 

reporting, the CEHRT definition 

requires criteria established by the 

Health IT Certification Program to be 

applied to the message being sent or 

received and for purposes of message 

transmission. However, to actually 

engage in e-Rx or public health 

reporting, there are many steps that 

must be taken to meet the requirements 

of the measure, such as contacting both 

parties and troubleshooting issues that 

may arise through the normal course of 

business. In these cases, the EP, eligible 

hospital, and CAH remain responsible 

for meeting the objectives and measures 

of meaningful use, but the way they do 

so is not entirely constrained by the 

CEHRT definition. 

(i) Discussion of the Relationship 

Between a Stage 3 Meaningful Use 

Objective and Its Associated Measure 

We propose to continue our Stage 1 

and 2 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 

meaningful use in Stage 3. 

Objective 1: Protect Patient Health 

Information 

The Health Insurance Portability and 

Accountability Act (HIPAA) was 

enacted in part to provide federal 

protections for individually identifiable 

health information (IIHI). The Secretary 

of HHS adopted what are commonly 

known as the HIPAA Privacy, Security 

and Breach Notification Rules (HIPAA 

Rules) to implement certain aspects of 

the HIPAA statute and the HITECH 

statute pertaining to a patient’s IIHI. The 

Privacy Rule provides protections for 

most individually identifiable health 

information, in any form or media, 

whether electronic, paper, or oral, held 

by covered entities and business 

associates. The Security Rule specifies a 

series of administrative, physical, and 

technical standards that provide 

protections for most electronic 

individually identifiable health 

information, held by covered entities 

and business associates. Covered 

entities consist of most health care 

providers, health plans, and health care 

clearinghouses. Business associates 

consist of persons or organizations that 

perform certain functions or activities 

on behalf of, or provide certain services 

to, covered entities or other business 

associates that involve the use or 

disclosure of individually identifiable 

health information. Individually 

identifiable health information is 

information that relates to an 

individual’s physical or mental health 

or condition, the provision of health 

care to an individual, or the payment for 

the provision of health care to an 

individual. Individually identifiable 

health information is information that 

identifies an individual directly or with 

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respect to which there is a reasonable 

basis to believe it can be used to identify 

an individual. The individually 

identifiable health information 

protected by the HIPAA Rules is known 

as ‘‘protected health information’’ and 

that information in electronic form is 

known as ‘‘electronic protected health 

information’’ (ePHI). The Privacy Rule 

can be found at 45 CFR Part160 and 

subparts A and E of part 164 and the 

Security Rule can be found at 45 CFR 

Part160 and Subparts A and C of Part 

164. Section 164.308(a)(1) of the 

Security Rule requires covered entities 

and business associates, among other 

things, to conduct a security risk 

analysis to assess the potential risks to 

the ePHI they create, receive, maintain, 

or transmit. 

Consistent with HIPAA and its 

implementing regulations, and as we 

stated under both the Stage 1 and Stage 

2 final rules (75 FR 44368 through 

44369 and 77 FR 54002 through 54003), 

protecting ePHI remains essential to all 

aspects of meaningful use under the 

EHR Incentive Programs. We remain 

cognizant that unintended or unlawful 

disclosures of ePHI could diminish 

consumer confidence in EHRs and the 

overall exchange of ePHI. Therefore, in 

both the Stage 1 and 2 final rules, we 

created a meaningful use core objective 

aimed at protecting patients’ health care 

information. Most recently, we finalized 

at (77 FR 54002 and 54003), a Stage 2 

meaningful use core objective requiring 

providers to ‘‘protect ePHI created or 

maintained by the certified EHR 

technology through the implementation 

of appropriate technical capabilities.’’ 

The measure for this objective requires 

providers to conduct or review a 

security risk analysis in accordance 

with the requirements under 45 CFR 

164.308(a)(1), including addressing the 

security (to include encryption) of data 

stored in CEHRT in accordance with 

requirements under 45 CFR 164.312 

(a)(2)(iv) and 45 CFR 164.306(d)(3), 

implementing security updates as 

necessary, and correcting identified 

security deficiencies as part of the 

provider’s risk management process. For 

further detail on this objective, we refer 

readers to the Stage 2 proposed and 

final rules (77 FR 13716 through 13717 

and 77 FR 54002). 

In this Stage 3 proposed rule, we 

continue to emphasize the importance 

of protecting ePHI under the EHR 

Incentive Programs. With more and 

more users using electronic health 

records, we believe that adequate 

protection of ePHI remains instrumental 

to the continued success of the EHR 

Incentive Program. 

However, public comments on the 

Stage 2 final rule and subsequent 

comments received through public 

forums, suggest some confusion remains 

among providers between the 

requirements of this meaningful use 

objective and the requirements 

established under 45 CFR 164.308(a)(1), 

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

164.306(d)(3) of the HIPAA Security 

Rule. Although we stressed that the 

objective and measure finalized relating 

to ePHI are specific to the EHR Incentive 

Programs, and further added that 

compliance with the requirements in 

the HIPAA Security Rule falls outside 

the scope of this rulemaking, we 

nonetheless continued to receive 

inquiries about the relationship between 

our objective and the HIPAA Rules. 

Therefore, for Stage 3, in order to 

alleviate provider confusion and 

simplify the EHR Incentive Program, we 

are proposing to maintain the 

previously finalized Stage 2 objective on 

protecting ePHI. However, we propose 

further explanation of the security risk 

analysis timing and review 

requirements for purposes of meeting 

this objective and associated measure 

for Stage 3. 

Proposed Objective: Protect electronic 

protected health information (ePHI) 

created or maintained by the certified 

EHR technology (CEHRT) through the 

implementation of appropriate 

technical, administrative, and physical 

safeguards. 

For the proposed Stage 3 objective, we 

have added language to the security 

requirements for the implementation of 

appropriate technical, administrative, 

and physical safeguards. We propose to 

include administrative and physical 

safeguards because an entity would 

require technical, administrative, and 

physical safeguards to enable it to 

implement risk management security 

measures to reduce the risks and 

vulnerabilities identified. Technical 

safeguards alone are not enough to 

ensure the confidentiality, integrity, and 

availability of ePHI. Administrative 

safeguards (for example, risk analysis, 

risk management, training, and 

contingency plans) and physical 

safeguards (for example, facility access 

controls, workstation security) are also 

required to protect against threats and 

impermissible uses or disclosures to 

ePHI created or maintained by CEHRT. 

Proposed Measure: Conduct or review 

a security risk analysis in accordance 

with the requirements under 45 CFR 

164.308(a)(1), including addressing the 

security (including encryption) of data 

stored in CEHRT in accordance with 

requirements under 45 CFR 

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

164.306(d)(3), implement security 

updates as necessary, and correct 

identified security deficiencies as part 

of the provider’s risk management 

process. 

Under this proposed measure, a risk 

analysis must assess the risks and 

vulnerabilities to ePHI created or 

maintained by the CEHRT and must be 

conducted or reviewed for each EHR 

reporting period, which, as proposed in 

this rule, would be a full calendar year, 

and any security updates and 

deficiencies identified should be 

included in the provider’s risk 

management process and implemented 

or corrected as dictated by that process. 

To address inquiries about the 

relationship between this measure and 

the HIPAA Security Rule, we explain 

that the requirement of this proposed 

measure is narrower than what is 

required to satisfy the security risk 

analysis requirement under 45 CFR 

164.308(a)(1). The requirement of this 

proposed measure is limited to annually 

conducting or reviewing a security risk 

analysis to assess whether the technical, 

administrative, and physical safeguards 

and risk management strategies are 

sufficient to reduce the potential risks 

and vulnerabilities to the 

confidentiality, availability, and 

integrity of ePHI created by or 

maintained in CEHRT. In contrast, the 

security risk analysis requirement under 

45 CFR 164.308(a)(1) must assess the 

potential risks and vulnerabilities to the 

confidentiality, availability, and 

integrity of all ePHI that an organization 

creates, receives, maintains, or 

transmits. This includes ePHI in all 

forms of electronic media, such as hard 

drives, floppy disks, CDs, DVDs, smart 

cards or other storage devices, personal 

digital assistants, transmission media, or 

portable electronic media. 

We propose that the timing or review 

of the security risk analysis to satisfy 

this proposed measure must be as 

follows: 

• EPs, eligible hospitals, and CAHs 

must conduct the security risk analysis 

upon installation of CEHRT or upon 

upgrade to a new Edition of certified 

EHR Technology. The initial security 

risk analysis and testing may occur prior 

to the beginning of the first EHR 

reporting period using that certified 

EHR technology. 

• In subsequent years, a provider 

must review the security risk analysis of 

the CEHRT and the administrative, 

physical, and technical safeguards 

implemented, and make updates to its 

analysis as necessary, but at least once 

per EHR reporting period. 

We note that providers have several 

resources available for strategies and 

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3 Data may be found on the CMS Web site data 

and program reports page: https://www.cms.gov/

Regulations-and-Guidance/Legislation/

EHRIncentivePrograms/DataAndReports.html. 

4 Data may be found on the CMS Web site data 

and program reports page: https://www.cms.gov/

Regulations-and-Guidance/Legislation/

EHRIncentivePrograms/DataAndReports.html. 

methods for securing ePHI. Completing 

a security risk analysis requires a time 

investment, and may necessitate the 

involvement of security, health IT, or 

system IT staff or support teams at your 

facility. The Office for Civil Rights 

(OCR) provides broad scale guidance on 

security risk analysis requirements at: 

http://www.hhs.gov/ocr/privacy/hipaa/

administrative/securityrule/

rafinalguidancepdf.pdf. 

In addition, other tools and resources 

are available to assist providers in the 

process. For example, the Office of the 

National Coordinator for Health IT 

(ONC) provides guidance and a Security 

Risk Assessment (SRA) tool created in 

conjunction with OCR on its Web site 

at: http://www.healthit.gov/providersprofessionals/security-risk-assessmenttool. The SRA Tool is a self-contained 

application available at no cost to the 

provider. There are a total of 156 

questions and resources are included 

with each question to— 

• Assist in understanding the context 

of the question 

• Consider the potential impacts to 

ePHI if the requirement is not met 

• See the actual safeguard language of 

the HIPAA Security Rule 

In addition, the SRA Tool assists a 

provider by suggesting when corrective 

action may be required for a particular 

item. This tool is not required by the 

HIPAA Security Rule, but is one means 

by which providers and professionals in 

small and medium sized practices may 

perform a security risk analysis. 

We further note that the 2015 Edition 

proposed rule published elsewhere in 

this issue of the Federal Register 

includes an auditable events and 

tamper-resistance criterion which is 

known as an ‘‘audit log’’ which can be 

a valuable resource in ensuring the 

protection of ePHI. While we recognize 

there may be legitimate instances where 

the function must be disabled for a short 

time, we strongly recommend providers 

ensure this function is enabled at all 

times when the CEHRT is in use. The 

audit log function serves to ensure 

consistent protection of ePHI as well as 

providing support in mitigating risk in 

other areas such as patient safety, 

adverse events, and in the event of any 

potential breach. 

We emphasize that our discussion of 

this measure as it relates to 45 CFR 

164.308(a)(1) is only relevant for 

purposes of the meaningful use 

requirements and is not intended to 

supersede or satisfy the broader, 

separate requirements under the HIPAA 

Security Rule and other rulemaking. 

Compliance with the requirements in 

the HIPAA Security Rule fall outside of 

the scope of this rulemaking. 

Compliance with 42 CFR part 2 and 

state mental health privacy and 

confidentiality laws also fall outside the 

scope of this rulemaking. EPs, eligible 

hospitals, or CAHs affected by 42 CFR 

part 2 should consult with the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) or 

State authorities. 

We welcome public comments on this 

proposal. 

Objective 2: Electronic Prescribing 

For Stage 3, we propose to maintain 

the objective and measure finalized in 

the Stage 2 final rule for electronic 

prescribing for EPs, with minor changes. 

In the Stage 2 final rule, we included for 

eligible hospitals and CAHs a menu set 

objective for the electronic prescription 

of discharge medications. We are 

proposing to include the Stage 2 menu 

objective, with a modification to 

increase the threshold, as a required 

objective for Stage 3 of meaningful use 

for eligible hospitals and CAHs. 

For a full discussion of electronic 

prescribing as a meaningful use 

objective in the Stage 2 final rule, we 

direct readers to (77 FR 53989 through 

53990 for EPs and 77 FR 54035 through 

54036 for eligible hospitals and CAHs). 

Proposed Objective: EPs must 

generate and transmit permissible 

prescriptions electronically, and eligible 

hospitals and CAHs must generate and 

transmit permissible discharge 

prescriptions electronically (eRx). 

As discussed in the Stage 2 final rule 

(77 FR 53989), transmitting the 

prescription electronically promotes 

efficiency and patient 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 that works in conjunction 

with clinical decision support 

interventions enabled at the generation 

of the prescription. While the EP 

performance rate across all years and 

stages of participation indicate wide 

spread adoption, with the median rate at 

89 percent for Stage 1 and 92 percent for 

Stage 2 3, we believe continued support 

of this objective is warranted to support 

the continued development of the 

ePrescribing marketplace. The 

continued expansion of the number and 

variety of products helps to reduce entry 

barriers and proliferate important 

standards for ePrescribing for a wide 

range of providers beyond those eligible 

for the EHR Incentive Programs. This 

represents a benefit to patients and to 

population health through a potential 

overall reduction in the occurrence of 

prescription drug related adverse 

events. For eligible hospitals and CAHs, 

the performance rate among Stage 2 

providers selecting the measure is 

higher than the 10 percent threshold 

and has increased since the previous 

report (median rate is 76 4 percent). This 

opportunity to expand on early success, 

combined with the continued expansion 

of the pharmacy market acceptance of 

electronic prescriptions leads CMS to 

believe providers can meet an even 

higher threshold and should be 

encouraged to do so. 

We propose to continue to define 

‘‘prescription’’ as the authorization by a 

provider to dispense a drug that would 

not be dispensed without such 

authorization. This includes 

authorization for refills of previously 

authorized drugs. We propose to 

continue to generally define a 

‘‘permissible prescription’’ as all drugs 

meeting the definition of prescription 

not listed as a controlled substance in 

Schedules II–V (DEA Web site at 

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

schedules/index.html (77 FR 53989) 

with a slight modification to allow for 

inclusion of scheduled drugs where 

such drugs are permissible to be 

electronically prescribed. We note that 

the electronic prescribing of controlled 

substances (EPCS) is now legal in many 

states. This functionality provides 

prescribers with a way to manage 

treatments for patients with pain 

electronically and also deters creation of 

fraudulent prescriptions, which is a 

major concern in combating opioid 

misuse and abuse. While the technology 

may, in many instances, be in place to 

support EPCS, workflow challenges and 

additional modifications may need to 

occur to meet the requirements of Drug 

Enforcement Agency regulations (75 FR 

16236). However, as Stage 3 would not 

begin until January of 2017 and would 

not be required until January of 2018, it 

is possible that significant progress in 

the availability of products enabling the 

electronic prescribing of controlled 

substances may occur. Therefore, we are 

proposing that providers who practice 

in a state where controlled substances 

may be electronically prescribed who 

wish to include these prescriptions in 

the numerator and denominator may do 

so under the definition of ‘‘permissible 

prescriptions’’ for their practice. If a 

provider chooses to include such 

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prescriptions, they must do so 

uniformly across all patients and across 

all allowable schedules for the duration 

of the EHR reporting period. 

For Stage 2, we requested comment 

on whether over-the-counter (OTC) 

medicines should be included in the 

definition of a prescription for this 

objective and determined that they 

should be excluded. For further 

information on that discussion, we 

direct readers to (77 FR 53989 and 

53990). We maintain that OTC 

medicines will not 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 and whether OTC 

medicines should be included in this 

objective for Stage 3. 

In the Stage 2 final rule at (77 FR 

53989), we discussed several different 

workflow scenarios that are possible 

when an EP prescribes a drug for a 

patient and that these differences in 

transmissions create differences in the 

need for standards. We propose to 

maintain this policy for Stage 3 for EPs 

and extend it to eligible hospitals and 

CAHs so that only a scenario in which 

a provider— 

• Prescribes the drug; 

• Transmits it to a pharmacy 

independent of the provider’s 

organization; and 

• The patient obtains the drug from 

that pharmacy requires the use of 

standards to ensure that the 

transmission meets the goals of 

electronic prescribing. In that situation, 

standards can ensure the whole process 

functions reliably. In all cases under 

this objective, the provider needs to use 

CEHRT as the sole means of creating the 

prescription, and when transmitting to 

an external pharmacy that is 

independent of the provider’s 

organization, such transmission must be 

pursuant to ONC Health IT Certification 

Program criteria. 

Proposed EP Measure: More than 80 

percent of all permissible prescriptions 

written by the EP are queried for a drug 

formulary and transmitted electronically 

using CEHRT. 

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 CEHRT. In the Stage 

1 final rule (75 FR 44338), we 

acknowledged that there were reasons 

why a patient may prefer a paper 

prescription such as the desire to shop 

for the best price (especially for patients 

in the Part D ‘‘donut hole’’), the 

indecision about whether to have the 

prescription filled locally or by mail 

order, and the desire to use a 

manufacturer coupon (except in the Part 

D program) to obtain a discount. 

In Stage 2, we adopted a measure of 

more than 50 percent of all permissible 

prescriptions written by the EP are 

queried for a drug formulary and 

transmitted electronically using CEHRT. 

Our analysis of attestation data from 

Stages 1 and 2 shows that the median 

performance on this measure for Stage 

1 EPs is 89 percent and for Stage 2 EPs 

is 92 percent, which demonstrates that 

the 50 percent threshold does not 

exceed the ceiling created by patient 

preferences 5. We believe that with 

continued experience with this 

objective and the continued expansion 

of the pharmacy market acceptance of 

electronic prescriptions, providers can 

meet an even higher threshold and 

should be encouraged to do so in line 

with the statutory directive to seek to 

improve the use of EHRs and health care 

quality over time by requiring more 

stringent measures of meaningful use 

(see section 1848(o)(2)(A)(iii) of the 

Act). Therefore, we are proposing a 

threshold of 80 percent for this measure 

for Stage 3. 

We propose to maintain for Stage 3 

the exclusion from Stage 2 for EPs who 

write fewer than 100 permissible 

prescriptions during the EHR reporting 

period. We also propose to maintain for 

Stage 3 the exclusion from Stage 2 if no 

pharmacies within a 10-mile radius of 

an EP’s practice location at the start of 

his or her EHR reporting period accept 

electronic prescriptions (77 FR 53990). 

This is 10 miles in any straight line from 

the practice location independent of the 

travel route from the practice location to 

the pharmacy. For EPs practicing at 

multiple locations, they are eligible for 

the exclusion if any of their practice 

locations equipped with CEHRT meet 

this criterion. 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 

10-mile radius regardless of whether 

that pharmacy can accept electronic 

prescriptions from EPs outside of the 

organization. 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

Denominator: Number of 

prescriptions written for drugs requiring 

a prescription in order to be dispensed 

other than controlled substances during 

the EHR reporting period or Number of 

prescriptions written for drugs requiring 

a prescription in order to be dispensed 

during the EHR reporting period. 

Numerator: The number of 

prescriptions in the denominator 

generated, queried for a drug formulary, 

and transmitted electronically using 

CEHRT. 

Threshold: The resulting percentage 

must be more than 80 percent in order 

for an EP to meet this measure. 

Exclusions: Any EP who: (1) Writes 

fewer than 100 permissible 

prescriptions during the EHR reporting 

period; or (2) does not have a pharmacy 

within their organization and there are 

no pharmacies that accept electronic 

prescriptions within 10 miles of the EP’s 

practice location at the start of his or her 

EHR reporting period. 

Proposed Eligible Hospital/CAH 

Measure: More than 25 percent of 

hospital discharge medication orders for 

permissible prescriptions (for new and 

changed prescriptions) are queried for a 

drug formulary and transmitted 

electronically using CEHRT. 

In the Stage 2 final rule, we included 

in this measure new, changed, and refill 

prescriptions ordered during the course 

of treatment of the patient while in the 

hospital (77 FR 54036). We are 

proposing to limit this measure for Stage 

3 to only new and changed 

prescriptions. We believe this limitation 

is appropriate 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 believe 

that in most cases a hospital would not 

issue refills for medications that were 

not authorized or altered during a 

patient’s hospital stay. With this new 

proposal, we invite public comment on 

whether a hospital would issue refills 

upon discharge for medications the 

patient was taking when they arrived at 

the hospital and, if so, whether 

distinguishing those refill prescriptions 

from new or altered prescriptions is 

unnecessarily burdensome for the 

hospital. 

Our review of the Stage 2 attestation 

data for eligible hospitals and CAHs 

indicates performance levels of 53 

percent at the median and 31 percent for 

the lowest quartile (www.cms.gov/

ehrincentiveprograms Data and 

Reports). Thus, we are proposing to 

increase the threshold for the measure 

from 10 percent to 25 percent for Stage 

3 of meaningful use for eligible 

hospitals and CAHs. 

We propose to maintain the Stage 2 

exclusion for any eligible hospital or 

CAH that does not have an internal 

pharmacy that can accept electronic 

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Web site at: http://www.fda.gov/downloads/

AboutFDA/CentersOffices/

OfficeofMedicalProductsandTobacco/CDRH/

CDRHReports/UCM391521.pdf. 

prescriptions and is not located within 

10 miles of any pharmacy that accepts 

electronic prescriptions at the start of 

their EHR reporting period (77 FR 

54036). 

We recognize that not every patient 

will have a formulary that is relevant for 

him or her. If a relevant formulary is 

available, then the information can be 

provided. If there is no formulary for a 

given patient, the comparison could 

return a result of formulary unavailable 

for that patient and medication 

combination, and the provider may 

count the prescription in the numerator 

if they generate and transmit the 

prescription electronically as required 

by the measure. 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

Denominator: The 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, queried for a drug formulary 

and transmitted electronically. 

Threshold: The resulting percentage 

must be more than 25 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 10 miles at the start 

of their EHR reporting period. 

We invite public comment on these 

proposals. 

Objective 3: Clinical Decision Support 

Proposed Objective: Implement 

clinical decision support (CDS) 

interventions focused on improving 

performance on high-priority health 

conditions. 

Clinical decision support at the 

relevant point of care is an area of 

health IT in which significant evidence 

exists for substantial positive impact on 

the quality, safety, and efficiency of care 

delivery. For Stage 2, we finalized an 

objective for the use of CDS to improve 

performance on high-priority health 

conditions, and two associated 

measures (77 FR 53995 through 53998). 

The first measure requires a provider to 

implement five CDS interventions 

related to four or more CQMs at a 

relevant point in patient care for the 

entire EHR reporting period. Absent 

four CQMs related to the provider’s 

scope of practice or patient population, 

the CDS interventions must be related to 

high-priority health conditions. At least 

one of the CDS interventions should be 

related to improving healthcare 

efficiency. To meet the Stage 2 Clinical 

Decision Support objective, providers 

must implement the CDS 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 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. 

For the second measure, we 

consolidated the Stage 1 ‘‘drug-drug/

drug-allergy interaction checks’’ 

objective into the Stage 2 CDS objective 

in the Stage 2 final rule (77 FR 53995 

through 53998). The second measure 

requires a provider to enable and 

implement the functionality for drugdrug and drug-allergy interaction checks 

for the entire EHR reporting period. We 

also finalized an exclusion for the 

second measure for any EP who writes 

fewer than 100 medication orders 

during the EHR reporting period. 

For Stage 3 of meaningful use, we 

propose to maintain the Stage 2 

objective with slight modifications and 

further explanation of the relevant point 

of care, the types of CDS allowed, and 

the selection of a CDS applicable to a 

provider’s scope of practice and patient 

population. 

First, we offer further explanation of 

the concept of the relevant point of care 

and note that providers should 

implement the CDS intervention at a 

relevant point in clinical workflows 

when the intervention can influence 

clinical decision making before 

diagnostic or treatment action is taken 

in response to the intervention. Second, 

many providers may associate CDS with 

pop-up alerts; however, these alerts are 

not the only method of providing CDS. 

CDS should not be viewed as simply an 

interruptive alert, notification, or 

explicit care suggestion. Well-designed 

CDS encompasses a variety of workflowoptimized information tools, which can 

be presented to providers, clinical and 

support staff, patients, and other 

caregivers at various points in time. 

These may include but are not limited 

to: Computerized alerts and reminders 

for providers and patients; information 

displays or links; context-aware 

knowledge retrieval specifications 

which provide a standard mechanism to 

incorporate information from online 

resources (commonly referred to as 

InfoButtons); clinical guidelines; 

condition-specific order sets; focused 

patient data reports and summaries; 

documentation templates; diagnostic 

support; and contextually relevant 

reference information. These 

functionalities may be deployed on a 

variety of platforms (that is, mobile, 

cloud-based, installed).6 We encourage 

innovative efforts to use CDS to improve 

care quality, efficiency, and outcomes. 

HIT functionality that builds upon the 

foundation of an EHR to provide 

persons involved in care processes with 

general and person-specific information, 

intelligently filtered and organized, at 

appropriate times, to enhance health 

and health care. CDS is not intended to 

replace clinician judgment, but rather, is 

a tool to assist care team members in 

making timely, informed, and higher 

quality decisions. 

We propose to retain both measures of 

the Stage 2 objective for Stage 3 and we 

are proposing that these additional 

options mentioned previously on the 

actions, functions, and interventions 

may constitute CDS for purposes of 

meaningful use would meet the measure 

requirements outlined in the proposed 

measures. 

Proposed Measures: EPs, eligible 

hospitals, and CAHs must satisfy both 

measures in order to meet the objective: 

Measure 1: Implement five clinical 

decision support interventions related 

to four or more CQMs at a relevant point 

in patient care for the entire EHR 

reporting period. Absent four CQMs 

related to an EP, eligible hospital, or 

CAH’s scope of practice or patient 

population, the clinical decision 

support interventions must be related to 

high-priority health conditions. 

Measure 2: The EP, eligible hospital, 

or CAH has enabled and implemented 

the functionality for drug-drug and 

drug-allergy interaction checks for the 

entire EHR reporting period. 

Exclusion: For the second measure, 

any EP who writes fewer than 100 

medication orders during the EHR 

reporting period. 

We recommend that providers explore 

a wide range of potential CDS 

interventions and determine the best 

mix for their practice and patient 

population. There are a wide range of 

CQMs which providers may implement 

in conjunction with the CDS. We refer 

readers to the CMS eCQM Library 

(www.cms.gov/ehrincentiveprograms/

ecqmlibrary) for a list of the CQMs 

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7HHS National Quality Strategy: http://

www.ahrq.gov/workingforquality/. 

currently in use and under development 

for CMS programs and the associated 

National Quality Strategy domain 

categories. 

In alignment with the HHS National 

Quality Strategy goals,7 providers are 

encouraged to implement CDS related to 

quality measurement and improvement 

goals on the following areas: 

• Preventive care. 

• Chronic condition management. 

• Heart disease and hypertension. 

• Appropriateness of diagnostic 

orders or procedures such as labs, 

diagnostic imaging, genetic testing, 

pharmacogenetic and pharmacogenomic 

test result support or other diagnostic 

testing. 

• Advanced medication-related 

decision support, to include 

pharmacogenetic and pharmacogenomic 

test result support. 

An example of a potential CDS a 

provider may include which highlights 

the proposed expansion of the variety of 

workflow-optimized tools available for 

providers, and the link between a CDS 

and a high priority health condition, 

may be found in the use of treatment 

protocols and algorithms within the 

Million Hearts initiative. The Million 

Hearts initiative emphasizes the use of 

treatment protocols which can be 

embedded throughout the clinical 

workflow for hypertension control to 

standardize a team’s or system’s 

approach to achieving outcomes of 

interest. These treatment protocols or 

algorithms can expand the number of 

care team members that can assist in 

achieving desired outcomes; lend 

clarity, efficiency, and cost-effectiveness 

to selection of medications; and specify 

intervals and processes for patient 

follow up for care related to 

hypertension. For further information 

on this example, we direct readers to the 

Million Hearts initiative protocols 

http://millionhearts.hhs.gov/resources/

protocols.html. In this example, these 

CDS interventions are applied to utilize 

standardized treatment approaches or 

protocols specific to hypertension 

control; however, we emphasize that 

similar strategies and approaches to the 

implementation of a variety of CDS can 

be widely applied. Another relevant 

example is clinical decision support in 

certified EHR technology that is used for 

consultation regarding appropriate use 

criteria for applicable imaging services 

as outlined in section 218 of the 

‘‘Protecting Access to Medicare Act of 

2014’’ which includes provisions 

focused on promoting evidence based 

care. We welcome public comments on 

the proposals. 

As in the Stage 2 final rule (77 FR 

53997), we do not propose to require the 

provider to report a change in 

performance on individual CQMs either 

independently or in relation to the 

paired CDS. Rather, we recommend 

each provider set internal goals for 

improved performance using the CQM, 

or related set of CQMs, as indicators for 

their own reference when selecting and 

implementing a CDS intervention. We 

note that for CDS and CQM pairings, we 

recommend providers focus on the use 

of CQMs which measure patient 

outcomes (also known as outcome 

measures), as preferred over CQMs 

which measure clinical process without 

consideration of a particular outcome 

(also known as process measures). 

Outcome measure CQMs are designed to 

provide a patient-centered and outcomefocused indicator for quality 

improvement goal-setting and planning. 

Where possible, we recommend 

providers implement CDS interventions 

which relate to care quality 

improvement goals and a related 

outcome measure CQM. However, for 

specialty hospitals and certain EPs, if 

there are no CQMs which are outcome 

measures related to their scope of 

practice, the provider should implement 

a CDS intervention related to a CQM 

process measure; or if none of the 

available CQMs apply, the provider 

should apply an intervention that he or 

she believes will be effective in 

improving the quality, safety, or 

efficiency of patient care. 

CMS and ONC are committed to 

harmonizing the quality improvement 

ecosystem, refining and developing 

outcome measures, and aligning 

standards for CDS and quality 

measurement. Work is underway in the 

ONC Standards and Interoperability 

Framework to align and develop a 

shared quality improvement data model 

and technical expression standards for 

both CDS and quality measurement. 

Upon successful completion, such 

standards may be considered for 

inclusion in future quality measurement 

and certification rulemaking. 

Given the wide range of CDS 

interventions currently available and 

the continuing development of new 

technologies, we do not believe that any 

EP, eligible hospital, or CAH would be 

unable to identify and implement five 

CDS interventions as previously 

described. Therefore, we do not propose 

any exclusion for the first measure of 

this objective. 

Objective 4: Computerized Provider 

Order Entry 

In the Stage 2 final rule, we expanded 

the use of computerized provider order 

entry (CPOE) from the Stage 1 objective 

requiring only medication orders to be 

entered using CPOE to include 

laboratory orders and radiology orders. 

For a full discussion of this expansion, 

we direct readers to (77 FR 53985 

through 53989). We maintain CPOE 

continues to represent an opportunity 

for providers to leverage technology to 

capture these orders to reduce error and 

maximize efficiencies within their 

practice, therefore we are proposing to 

maintain the use of CPOE for these 

orders as an objective of meaningful use 

for Stage 3. 

Proposed Objective: Use 

computerized provider order entry 

(CPOE) for medication, laboratory, and 

diagnostic imaging orders directly 

entered by any licensed healthcare 

professional, credentialed medical 

assistant, or a medical staff member 

credentialed to and performing the 

equivalent duties of a credentialed 

medical assistant; who can enter orders 

into the medical record per state, local, 

and professional guidelines. 

We propose to continue to define 

CPOE as the provider’s use of computer 

assistance to directly enter clinical 

orders (for example, medications, 

consultations with other providers, 

laboratory services, imaging studies, and 

other auxiliary services) from a 

computer or mobile device. The order is 

then documented or captured in a 

digital, structured, and computable 

format for use in improving safety and 

efficiency of the ordering process. 

We propose to continue our policy 

from the Stage 2 final rule that the 

orders to be included in this objective 

are medication, laboratory, and 

radiology orders as such orders are 

commonly included in CPOE 

implementation and offer opportunity to 

maximize efficiencies for providers. 

However, for Stage 3, we are proposing 

to expand the objective to include 

diagnostic imaging, which is a broader 

category including other imaging tests 

such as ultrasound, magnetic resonance, 

and computed tomography in addition 

to traditional radiology. This change 

addresses the needs of specialists and 

allows for a wider variety of clinical 

orders relevant to particular specialists 

to be included for purposes of 

measurement. 

In Stage 3, we propose to continue the 

policy from the Stage 2 final rule at 77 

FR 53986 that orders entered by any 

licensed healthcare professional or 

credentialed medical assistant would 

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8 Data can be found on the CMS Web site data and 

program reports page: https://www.cms.gov/

Regulations-and-Guidance/Legislation/

EHRIncentivePrograms/DataAndReports.html. 

count toward this objective. A 

credentialed medical assistant may 

enter orders if they are credentialed to 

perform the duties of a medical assistant 

by a credentialing body other than the 

employer. If a staff member of the 

eligible provider is appropriately 

credentialed and performs assistive 

services similar to a medical assistant, 

but carries a more specific title due to 

either specialization of their duties or to 

the specialty of the medical professional 

they assist, orders entered by that staff 

member would be included in this 

objective. We further note that medical 

staff whose organizational or job title, or 

the title of their credential, is other than 

medical assistant may enter orders if 

these staff are credentialed to perform 

the equivalent duties of a credentialed 

medical assistant by a credentialing 

body other than their employer and 

perform such duties as part of their 

organizational or job title. We defer to 

the provider’s discretion to determine 

the appropriateness of the credentialing 

of staff to ensure that any staff entering 

orders have the clinical training and 

knowledge required to enter orders for 

CPOE. This determination must be 

made by the EP or representative of the 

eligible hospital or CAH based on— 

• Organizational workflows; 

• Appropriate credentialing of the 

staff member by an organization other 

than the employing organization; 

• Analysis of duties performed by the 

staff member in question; and 

• Compliance with all applicable 

federal, state, and local laws and 

professional guidelines. 

However, as stated in the Stage 2 final 

rule at 77 FR 53986, it is apparent that 

the prevalent time when CDS 

interventions are presented is when the 

order is entered into CEHRT, and that 

not all EHRs also present CDS when the 

order is authorized (assuming such a 

multiple step ordering process is in 

place). This means that the person 

entering the order would be required to 

enter the order correctly, evaluate a CDS 

intervention either using their own 

judgment or through accurate relay of 

the information to the ordering 

provider, and then either make a change 

to the order based on the information 

provided by the CDS intervention or 

bypass the intervention. The execution 

of this role represents a significant 

impact on patient safety; therefore, we 

continue to maintain for Stage 3 that a 

layperson is not qualified to perform 

these tasks. We believe that the order 

must be entered by a qualified 

individual. We further propose that if 

the individual entering the orders is not 

the licensed healthcare professional, the 

order must be entered with the direct 

supervision or active engagement of a 

licensed healthcare professional. 

We propose to maintain for Stage 3 

our existing policy for Stages 1 and 2 

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. 

The numerator of this objective also 

includes orders entered using CPOE 

initially when the patient record became 

part of the certified EHR. This does not 

include paper orders entered initially 

into the patient record and then 

transferred to CEHRT by other 

individuals at a later time, nor does it 

include orders entered into technology 

not compliant with the CEHRT 

definition and transferred into the 

CEHRT at a later time. In addition, 

based on the discussion in the Stage 2 

final rule (77 FR 53986), we propose to 

maintain for Stage 3 that ‘‘protocol’’ or 

‘‘standing’’ orders may be excluded 

from this objective. The defining 

characteristic of these orders is that they 

are not created due to a specific clinical 

determination by the ordering provider 

for a given patient, but rather are 

predetermined for patients with a given 

set of characteristics (for example, 

administer medication X and order lab 

Y for all patients undergoing a certain 

specific procedure or refills for given 

medication). We agree that this category 

of orders warrant different 

considerations than orders that are due 

to a specific clinical determination by 

the ordering provider for a specific 

patient. Therefore, we allow providers 

to exclude orders that are 

predetermined for a given set of patient 

characteristics or for a given procedure 

from the calculation of CPOE 

numerators and denominators. 

However, the exclusion of this type of 

order may not be a blanket policy for 

patients presenting with a specific 

diagnosis or symptom which requires 

the evaluation and determination of the 

provider for the order. 

We propose to maintain the Stage 2 

description of ‘‘laboratory services’’ as 

any service provided by a laboratory 

that could not be provided by a nonlaboratory for the CPOE objective for 

Stage 3 (77 FR 53984). We also propose 

to maintain for Stage 3 the Stage 2 

description of ‘‘radiologic services’’ as 

any imaging service that uses electronic 

product radiation (77 FR 53986). Even 

though we are proposing to expand the 

CPOE objective from radiology orders to 

all diagnostic imaging orders, this 

description would still apply for 

radiology services within the expanded 

objective. 

We invite public comment on these 

proposals. 

Proposed Measures: An EP, eligible 

hospital or CAH must meet all three 

measures. 

Proposed Measure 1: More than 80 

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 computerized provider 

order entry; 

Proposed Measure 2: More than 60 

percent of laboratory orders created by 

the EP or authorized providers of the 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period are 

recorded using computerized provider 

order entry; and 

Proposed Measure 3: More than 60 

percent of diagnostic imaging 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 

computerized provider order entry. 

We propose to continue a separate 

percentage threshold for all three types 

of orders: medication, laboratory, and 

diagnostic imaging. We continue to 

believe that an aggregate denominator 

cannot best capture differentiated 

performance on the individual order 

types within the objective, and therefore 

maintain a separate denominator for 

each order type. We propose to retain 

exclusionary criteria from Stage 2 for 

those EPs who so infrequently issue an 

order type specified by the measures 

(write fewer than 100 of the type of 

order), that it is not practical to 

implement CPOE for that order type. 

Based on our review of attestation 

data from Stages 1 and 2 demonstrating 

provider performance on the CPOE 

measures, we propose to increase the 

threshold for medication orders to 80 

percent and to increase the threshold for 

diagnostic imaging orders and 

laboratory orders to 60 percent. Median 

performance for Stage 1 on medication 

orders is 95 percent for EPs and 93 

percent foreligible hospitals and CAHs. 

Stage 2 median performance on 

laboratory and radiology orders is 80 

percent and 83 percent for eligible 

hospitals and CAHs and 100 percent for 

EPs for both measures.8 We believe it is 

reasonable to expect the actual use of 

CPOE for medication orders to increase 

from 60 percent in Stage 2 to 80 percent 

in Stage 3 and the actual use of CPOE 

for diagnostic imaging and laboratory 

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orders to increase from 30 percent in 

Stage 2 to 60 percent in Stage 3. We note 

that despite the expansion of the 

category for radiology orders to 

diagnostic imaging orders, we do not 

anticipate a negative impact on the 

ability of providers to meet the higher 

threshold as the adoption of the 

expanded functionality does not require 

additional workflow implementation 

and allows for inclusion of a wider 

range of orders already being captured 

by many providers. Therefore, for 

medication orders we propose the 

threshold at 80 percent and for 

diagnostic imaging and laboratory 

orders we propose the threshold at 60 

percent for Stage 3. 

In the Stage 2 final rule, we addressed 

the concern posed when calculating a 

denominator of all orders entered into 

the CEHRT while limiting the 

numerator to only those entered into 

CEHRT using CPOE (77 FR 53987 

through 53988). Potentially, this would 

exclude those orders that are never 

entered into the CEHRT in any manner. 

The provider would be responsible for 

including those orders in their 

denominator. However, we believe that 

providers using CEHRT use it as the 

patient’s medical record; therefore, an 

order not entered into CEHRT 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 

CEHRT to be few in number or nonexistent. While our experience with 

both Stage 1 and Stage 2 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 and would 

create a better measurement for CPOE 

usage, particularly for EPs who 

infrequently order medications, this 

does not guarantee such a denominator 

would be feasible for all providers. We 

invite comments on whether to continue 

to allow, but not require, providers to 

limit the measure of this objective to 

those patients whose records are 

maintained using CEHRT. 

Proposed Measure 1: To calculate the 

percentage, CMS and ONC have worked 

together to define the following for this 

measure: 

Denominator: Number of medication 

orders created by the EP or authorized 

providers in the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period. 

Numerator: The number of orders in 

the denominator recorded using CPOE. 

Threshold: The resulting percentage 

must be more than 80 percent in order 

for an EP, eligible hospital, or CAH to 

meet this measure. 

Exclusion: Any EP who writes fewer 

than 100 medication orders during the 

EHR reporting period. 

Proposed Measure 2: To calculate the 

percentage, CMS and ONC have worked 

together to define the following for this 

measure: 

Denominator: Number of laboratory 

orders created by the EP or authorized 

providers in the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period. 

Numerator: The number of orders in 

the denominator recorded using CPOE. 

Threshold: The resulting percentage 

must be more than 60 percent in order 

for an EP, eligible hospital, or CAH to 

meet this measure. 

Exclusion: Any EP who writes fewer 

than 100 laboratory orders during the 

EHR reporting period. 

Proposed Measure 3: To calculate the 

percentage, CMS and ONC have worked 

together to define the following for this 

measure: 

Denominator: Number of diagnostic 

imaging orders created by the EP or 

authorized providers in the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period. 

Numerator: The number of orders in 

the denominator recorded using CPOE. 

Threshold: The resulting percentage 

must be more than 60 percent in order 

for an EP, eligible hospital, or CAH to 

meet this measure. 

Exclusion: Any EP who writes fewer 

than 100 diagnostic imaging orders 

during the EHR reporting period. 

We seek comment on if there are 

circumstances which might warrant an 

additional exclusion for an EP such as 

a situation representing a barrier to 

successfully implementing the 

technology required to meet the 

objective. We also seek comment on if 

there are circumstances where an 

eligible hospital or CAH which focuses 

on a particular patient population or 

specialty may have an EHR reporting 

period where the calculation results in 

a zero denominator for one of the 

measures, how often such 

circumstances might occur, and whether 

an exclusion would be appropriate. 

An EP through a combination of 

meeting the thresholds and exclusions 

must satisfy all three measures for this 

objective. An eligible hospital or CAH 

must meet the thresholds for all three 

measures. 

We welcome public comment on 

these proposals. 

Objective 5: Patient Electronic Access to 

Health Information 

The Stage 1 and Stage 2 final rules 

included a number of objectives focused 

on increasing patient access to health 

information and supporting provider 

and patient communication. These 

objectives include patient reminders (77 

FR 54005 through 54007), patientspecific education resources (77 FR 

54011 through 54012), clinical 

summaries of office visits (77 FR 53998 

through 54002), secure messaging (77 

FR 54031 through 54033), and the 

ability for patients to view, download, 

and transmit their health information to 

a third party (77 FR 54007 through 

54011). For Stage 3, we generally 

identified two related policy goals 

within the overall larger goal of 

improved patient access to health 

information and patient-centered 

communication. The first is to ensure 

patients have timely access to their full 

health record and related important 

health information; and the second is to 

engage in patient-centered 

communication for care planning and 

care coordination. While these two goals 

are intricately linked, we see them as 

two distinct priorities requiring 

different foci and measures of success. 

For the first goal, we are proposing to 

incorporate the Stage 2 objectives 

related to providing patients with access 

to health information, including the 

objective for providing access for 

patients (or their authorized 

representatives) to view online, 

download, and transmit their health 

information and the objective for 

patient-specific education resources, 

into a new Stage 3 objective entitled, 

‘‘Patient Electronic Access’’ (Objective 

5), focused on using certified EHR 

technology to support increasing patient 

access to important health information. 

For the second goal, we are proposing 

an objective entitled Coordination of 

Care through Patient Engagement 

(Objective 6) incorporating the policy 

goals of the Stage 2 objectives related to 

secure messaging, patient reminders, 

and the ability for patients (or their 

authorized representatives) to view 

online, download, and transmit their 

health information using the 

functionality of the certified EHR 

technology. 

In this Stage 3 Patient Electronic 

Access Objective, we are proposing to 

incorporate certain measures and 

objectives from Stage 2 into a single 

objective focused on providing patients 

with timely access to information 

related to their care. This proposed 

objective is a consolidation of the first 

measure of the Stage 2 Core Objective 

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9 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. 

10The 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. 

for EPs of ‘‘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’’ and the Stage 2 

Core Objective for EPs to ‘‘Use clinically 

relevant information from CEHRT to 

identify patient-specific education 

resources and provide those resources to 

the patient.’’ For eligible hospitals and 

CAHs, this proposed objective 

consolidates the first measure of the 

Stage 2 Core Objective for eligible 

hospitals/CAHs of ‘‘Provide patients the 

ability to view online, download, and 

transmit information about a hospital 

admission’’ and the Stage 2 Core 

Objective ‘‘Use clinically relevant 

information from CEHRT to identify 

patient-specific education resources and 

provide those resources to the patient.’’ 

For further discussion around the 

development of the Stage 2 objectives, 

we direct readers to the Stage 2 final 

rule at (77 FR 53973). 

In Stage 2, there are objectives that 

allow providers to communicate and 

provide information to patients through 

paper-based means, such as clinical 

summaries of office visits and patientspecific education resources. Although 

these methods of communication and 

information exchange are embraced by 

many providers and patients and we 

continue to support their use, we will 

no longer require or allow providers to 

capture and calculate these actions or 

attest to these measures for meaningful 

use Stage 3. While we believe that 

providing patients access to health 

information in many formats is 

beneficial to patient-centered 

communication, care delivery, and 

quality improvement, meaningful use 

Stage 3 focuses exclusively on 

electronic, certified EHR technology 

supported communication. 

We are also proposing to expand the 

options through which providers may 

engage with patients under the EHR 

Incentive Programs. Specifically, we are 

proposing an additional functionality, 

known as application-program 

interfaces (APIs), which would allow 

providers to enable new functionalities 

to support data access and patient 

exchange. An API is a set of 

programming protocols established for 

multiple purposes. APIs may be enabled 

by a provider or provider organization 

to provide the patient with access to 

their health information through a thirdparty application with more flexibility 

than often found in many current 

‘‘patient portals.’’ From the provider 

perspective, using this option would 

mean the provider would not be 

required to separately purchase or 

implement a ‘‘patient portal,’’ nor 

would they need to implement or 

purchase a separate mechanism to 

provide the secure download and 

transmit functions for their patients 

because the API would provide the 

patient the ability to download or 

transmit their health information to a 

third party. If the provider elects to 

implement an API, the provider would 

only need to fully enable the API 

functionality, provide patients with 

detailed instructions on how to 

authenticate, and provide supplemental 

information on available applications 

which leverage the API. For further 

discussion on the technical 

requirements for APIs, we direct readers 

to the 2015 Edition proposed rule 

published elsewhere in this issue of the 

Federal Register. The certification 

criteria proposed by ONC would 

establish API criteria which would 

allow patients, through a third-party 

application, to pull certain components 

of their unique health data directly from 

the provider’s CEHRT, and potentially 

could—on demand—pull such 

information from multiple providers 

caring for a patient. Therefore, we are 

proposing for the Patient Electronic 

Access objective to allow providers to 

enable API functionality in accordance 

with the proposed ONC requirements in 

the 2015 Edition proposed rule 

published elsewhere in this issue of the 

Federal Register. 

From the patient perspective, an API 

enabled by a provider will empower the 

patient to receive information from their 

provider in the manner that is most 

valuable to that particular patient. 

Patients would be able to collect their 

health information from multiple 

providers and potentially incorporate all 

of their health information into a single 

portal, application, program, or other 

software. We also believe that providerenabled APIs allow patients to control 

the manner in which they receive their 

health information while still ensuring 

the interoperability of data across 

platforms. In addition, we recognize that 

a large number of patients consult with 

and rely on trusted family members and 

other caregivers to help coordinate care, 

understand health information, and 

make decisions. Therefore, we 

encourage providers to provide access to 

health information to appropriately 

authorized patient representatives. 

As some low-cost and free API 

functions already exist in the health IT 

industry, we expect third-party 

application developers to continue to 

create low-cost solutions that leverage 

APIs as part of their business models. 

Therefore, we encourage health IT 

system developers to leverage these 

existing API platforms and applications 

to allow providers no-cost, or low-cost 

solutions to implement and enable an 

API as part of their CEHRT systems. In 

addition, we do not believe it would be 

appropriate for EPs and hospitals to 

charge patients a fee for accessing their 

information using an API. 

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 and share their most 

recent clinical information with other 

health care providers and personal 

caregivers as they see fit. We believe 

this is also integral to the hospital 

Partnership for Patients initiative and 

reducing hospital readmissions. This 

objective aligns with the Fair 

Information Practice Principles 

(FIPPS),9 in affording baseline privacy 

protections to individuals.10

We seek comment on what additional 

requirements might be needed to ensure 

that if the eligible hospital, CAH or EP 

selects the API option—(1) the 

functionality supports a patient’s right 

to have his or her protected health 

information sent directly to a third party 

designated by the patient; and (2) 

patients have at least the same access to 

and use of their health information that 

they have under the view, download, 

and transmit option. 

Proposed Objective: The EP, eligible 

hospital, or CAH provides access for 

patients to view online, download, and 

transmit their health information, or 

retrieve their health information 

through an API, within 24 hours of its 

availability. 

We continue to believe that patient 

access to their electronic health 

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information is a high priority for the 

EHR Incentive Programs. Furthermore, 

providing educational resources about a 

patient’s health including 

recommendations for preventative care 

and screenings, identifying risk factors, 

and other important health resources 

can help to increase patient health 

literacy, empower patients to make 

more informed decisions, and support 

the efforts of providers in managing a 

patient care plan. We also believe that 

patient access to health information 

should be provided in the manner 

requested by the patient when possible. 

We note that for this objective, the 

provider is only required to provide 

access to the information through these 

means; the patient is not required to 

take action in order for the provider to 

meet this objective. In the Patient 

Electronic Access to Health Information 

objective, we note that ‘‘provides 

access’’ means that the patient has all 

the tools they need to gain access to 

their health information including any 

necessary instructions, user 

identification information, or the steps 

required to access their information if 

they have previously elected to ‘‘optout’’ of electronic access. If this 

information is provided to the patient in 

a clear and actionable manner, the 

provider may count the patient for this 

objective. Additionally, this objective 

should not require the provider to make 

extraordinary efforts to assist patients in 

use or access of the information, but the 

provider must inform patients of these 

options, and provide sufficient guidance 

so that all patients could leverage this 

access. The providers may withhold 

from online disclosure any information 

either prohibited by federal, state, or 

local laws or if such information 

provided through online means may 

result in significant harm. We also note, 

as we have previously, that this is a 

meaningful use requirement, which 

does not affect an individual’s 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. 

Proposed Measures: EPs, eligible 

hospitals, and CAHs must satisfy both 

measures in order to meet the objective: 

Proposed Measure 1: For more than 

80 percent of all unique patients seen by 

the EP or discharged from the eligible 

hospital or CAH inpatient or emergency 

department (POS 21 or 23): 

(1) The patient (or patient-authorized 

representative) is provided access to 

view online, download, and transmit 

their health information within 24 hours 

of its availability to the provider; or 

(2) The patient (or patient-authorized 

representative) is provided access to an 

ONC-certified API that can be used by 

third-party applications or devices to 

provide patients (or patient-authorized 

representatives) access to their health 

information, within 24 hours of its 

availability to the provider. 

Proposed Measure 2: The EP, eligible 

hospital or CAH must use clinically 

relevant information from CEHRT to 

identify patient-specific educational 

resources and provide electronic access 

to those materials to more than 35 

percent of unique patients seen by the 

EP or discharged from the eligible 

hospital or CAH inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period. 

We propose that for measure 1, the 

patient must be able to access this 

information on demand, such as 

through a patient portal, personal health 

record (PHR), or API and have 

everything necessary to access the 

information even if they opt out. All 

three functionalities (view, download, 

and transmit) or an API must be present 

and accessible to meet the measure. The 

functionality must support a patient’s 

right to have his or her protected health 

information sent directly to a third party 

designated by the patient consistent 

with the provision of access 

requirements at 45 CFR 164.524(c) of 

the HIPAA Privacy Rule. 

However, if the provider can 

demonstrate that at least one application 

that leverages the API is available 

(preferably at no cost to the patient) and 

that more than 80 percent of all unique 

patients have been provided 

instructions on how to access the 

information; the provider need not 

create, purchase, or implement 

redundant software to enable view, 

download, and transmit capability 

independently of the API. 

We propose to increase the threshold 

for measure 1 from the Stage 1 and Stage 

2 threshold of 50 percent to a threshold 

of 80 percent for Stage 3. We believe 

that all patients should be provided 

access to their electronic health record; 

however, we are setting the threshold at 

80 percent based on the highest 

threshold defined for measures based on 

unique patients seen by the provider 

during the EHR reporting period in the 

Stage 2 final rule (for example see 77 FR 

53993). Based on the continued progress 

toward automation and standardization 

of data capture supported by CEHRT 

which facilitates a faster response time, 

we further propose to decrease patient 

wait time for the availability of 

information to within 24 hours of the 

office visit or of the information 

becoming available to the provider for 

potential inclusion in the case of lab or 

other test results which require 

sufficient time for processing and 

returning results. 

For measure 2, we propose to increase 

the threshold that was finalized in Stage 

2 from 10 percent to 35 percent. We 

believe that the 35 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. 

We continue to propose that both 

measures for this objective must be met 

using CEHRT. For the purposes of 

meeting this objective, this would mean 

the capabilities provided by a patient 

portal, PHR, or any other means of 

online access that would permit a 

patient or authorized representatives to 

view, download, and transmit their 

personal health information and/or any 

API enabled, must be certified in 

accordance with the certification 

requirements adopted by ONC. 

We are proposing a continuation of 

the exclusion in Stage 2 for both EPs 

and eligible hospitals/CAHs in that any 

EP, eligible hospital, or CAH would be 

excluded from the first 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. 

We continue to 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. Finally, we 

propose an additional exclusion for EPs 

for Stage 3, that any EP who has no 

office visits during the EHR reporting 

period may be excluded from the 

measures. We encourage comments on 

these exclusions and will evaluate them 

again in light of the public comments 

received. 

Proposed Measure 1: To calculate the 

percentage, CMS and ONC have worked 

together to define the following for this 

measure: 

Denominator: The number of unique 

patients seen by the EP or the number 

of unique patients discharged from an 

eligible hospital or CAH inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period. 

Numerator: The number of patients in 

the denominator who are provided 

access to information within 24 hours of 

its availability to the EP or eligible 

hospital/CAH. 

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Threshold: The resulting percentage 

must be more than 80 percent in order 

for a provider to meet this measure. 

Exclusions: An EP may exclude from 

the measure if they have no office visits 

during the EHR reporting period. 

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 the 

measure. 

Any eligible hospital or CAH will be 

excluded from the 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. 

Proposed Measure 2: To calculate the 

percentage, CMS and ONC have worked 

together to define the following for this 

measure: 

Denominator: The number of unique 

patients seen by the EP or the number 

of unique patients discharged from an 

eligible hospital or CAH inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period. 

Numerator: The number of patients in 

the denominator who were provided 

electronic access to patient-specific 

educational resources using clinically 

relevant information identified from 

CEHRT. 

Threshold: The resulting percentage 

must be more than 35 percent in order 

for a provider to meet this measure. 

Exclusions: An EP may exclude from 

the measure if they have no office visits 

during the EHR reporting period. 

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 the 

measure. 

Any eligible hospital or CAH will be 

excluded from the 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. 

Alternate Proposals: 

We note that for measure one we are 

seeking comment on the following set of 

alternate proposals for providers to meet 

the measure using the functions of 

CEHRT outlined previously in this 

section. These alternate proposals 

involve the requirements to use a view, 

download, and transmit function or an 

API to provide patients access to their 

health information. We believe the 

current view, download, and transmit 

functions are widely in use and 

represent the current standard for 

patient access to their health record. 

However, we believe that the use of 

APIs could potentially replace this 

function and move toward a more 

accessible means for patients to access 

their information. Therefore, we are 

seeking comment on alternatives which 

would present a different mix of CEHRT 

functionality for providers to use for 

patients seeking to access their records. 

The proposed first measure discussed 

previously would allow providers the 

option either to give patients access to 

the view, download, and transmit 

functionality, or to give patients access 

to an API. Specifically, we are seeking 

comment on whether the API option 

should be required rather than optional 

for providers, and if so, should 

providers also be required to offer the 

view, download, and transmit function. 

Proposed Measure 1: For more than 

80 percent of all unique patients seen by 

the EP or discharged from the eligible 

hospital or CAH inpatient or emergency 

department (POS 21 or 23): 

(1) The patient (or patient-authorized 

representative) is provided access to 

view online, download, and transmit 

their health information within 24 hours 

of its availability to the provider; or 

(2) The patient (or the patientauthorized representative) is provided 

access to an ONC-certified API that can 

be used by third-party applications or 

devices to provide patients (or patient 

authorized representatives) access to 

their health information, within 24 

hours of its availability to the provider. 

Alternate A: For more than 80 percent 

of all unique patients seen by the EP or 

discharged from the eligible hospital or 

CAH inpatient or emergency department 

(POS 21 or 23): 

(1) The patient (or the patientauthorized representative) is provided 

access to view online, download, and 

transmit his or her health information 

within 24 hours of its availability to the 

provider; and 

(2) The patient (or patient-authorized 

representatives) is provided access to an 

ONC-certified API that can be used by 

third-party applications or devices to 

provide patients (or patient authorized 

representatives) access to their health 

information within 24 hours of its 

availability to the provider. 

Alternate B: For more than 80 percent 

of all unique patients seen by the EP or 

discharged from the eligible hospital or 

CAH inpatient or emergency department 

(POS 21 or 23): 

(1) The patient (or patient-authorized 

representative) is provided access to 

view online, download, and transmit 

their health information within 24 hours 

of its availability to the provider; and 

the patient (or patient-authorized 

representative) is provided access to an 

ONC-certified API that can be used by 

third-party applications or devices to 

provide patients (or patient authorized 

representatives) access to their health 

information within 24 hours of its 

availability to the provider; or, 

(2) The patient (or patient-authorized 

representatives) is provided access to an 

ONC-certified API that can be used by 

third-party applications or devices to 

provide patients (or patient authorized 

representatives) access to their health 

information within 24 hours of its 

availability to the provider. 

Alternate C: For more than 80 percent 

of all unique patients seen by the EP or 

discharged from the eligible hospital or 

CAH inpatient or emergency department 

(POS 21 or 23), the patient (or patientauthorized representative) is provided 

access to an ONC-certified API that can 

be used by third-party applications or 

devices to provide patients (or patientauthorized representatives) access to 

their health information, within 24 

hours of its availability to the provider. 

These three alternate proposals would 

represent different use cases for the 

CEHRT function to support view, 

download, and transmit and/or API 

functionality. We note that under these 

proposed alternates the following mix of 

functions would be applicable: 

Alternate A would require both 

functions to be available instead of 

allowing the provider to choose between 

the two; Alternate B would require the 

provider to choose to have either both 

functions, or just an API function; and 

Alternate C would require the provider 

to only have the API function. For 

Alternate C, the use of a separate view, 

download, and transmit function would 

be entirely at the provider’s discretion 

and not included as part of the 

definition of meaningful use. 

We welcome public comment on 

these proposals. 

Objective 6: Coordination of Care 

Through Patient Engagement 

As mentioned previously, the Stage 1 

and Stage 2 final rules included a 

number of objectives focused on patient 

access to health information and 

communication among providers, care 

teams, and patients. These patient 

engagement objectives focused on 

changing behaviors among providers 

and patients to promote patient 

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11 Data can be found on CMS Web site Data and 

Program Reports page: https://www.cms.gov/

Regulations-and-Guidance/Legislation/

EHRIncentivePrograms/DataAndReports.html. 

involvement in health care. Specifically, 

the objectives included supporting 

provider and patient communication 

about their health, improving overall 

patient health literacy, and supporting 

patient-driven coordination with 

providers and other members of the 

patient’s care team. The Stage 1 and 

Stage 2 objectives included patient 

reminders (77 FR 54005 through 54007), 

patient-specific education resources (77 

FR 54011 through 54012), clinical 

summaries of office visits (77 FR 53998 

through 54002), secure messaging (77 

FR 54031 through 54033), and the 

ability for patients to view, download, 

and transmit their health information to 

a third party (77 FR 54007 through 

54011). For Stage 3, as mentioned 

previously, we are proposing to 

incorporate the Stage 2 objectives 

related to providing patients with access 

to health information into a new Stage 

3 objective entitled, ‘‘Patient Electronic 

Access’’ (Objective 5). For the proposed 

objective entitled Coordination of Care 

through Patient Engagement (Objective 

6), we are proposing to incorporate the 

policy goals of the Stage 2 objectives 

related to secure messaging, patient 

reminders, and the measure of patient 

engagement requiring patients (or their 

authorized representatives) to view, 

download, and transmit their health 

information using the functionality of 

the certified EHR technology. 

As mentioned previously, while we 

believe there may be many methods of 

communication and information sharing 

among providers, or other care team 

members, and patients (including paperbased or telephone communications), 

meaningful use Stage 3 focuses 

exclusively on electronic, certified EHR 

technology supported communication 

in the requirements outlined in this 

proposed objective for Coordination of 

Care through Patient Engagement. 

Proposed Objective: Use 

communications functions of certified 

EHR technology to engage with patients 

or their authorized representatives about 

the patient’s care. 

Specifically, this proposed rule 

focuses on encouraging the use of EHR 

functionality for secure dialogue and 

efficient communication between 

providers, care team members, and 

patients about their care and health 

status, as well as important health 

information such as preventative and 

coordinated care planning. In addition, 

certified EHR technology functions 

designed to support patient engagement 

can be a platform to securely capture 

and record patient-generated health data 

and information provided in nonclinical care settings. 

We are also proposing to expand the 

options through which providers may 

engage with patients under the EHR 

Incentive Programs including the use of 

APIs as mentioned previously. An API 

can enable a patient—through a thirdparty application—to access and 

retrieve their health information from a 

care provider in a way that is most 

valuable to that particular patient. 

Therefore, we are proposing a 

meaningful use objective for Stage 3 to 

support this provider and patient 

engagement continuum based on the 

foundation already created within the 

EHR Incentive Programs but using new 

methods and expanded options to 

advance meaningful patient engagement 

and patient-centered care. We also 

propose that for purposes of this 

objective, patient engagement may 

include patient-centered 

communication between and among 

providers facilitated by authorized 

representatives of the patient and of the 

EP, eligible hospital, or CAH. As care 

delivery evolves, the participation of a 

diverse group of care team members 

enables more robust care for the patient. 

Engagement between the patient and, 

for example, nutritionists, social 

workers, physical therapists, or other 

members of the provider’s care team is 

crucial to effective patient engagement 

and are therefore included in this 

objective. 

For Stage 3 of meaningful use, we 

propose the following measures for the 

Patient Engagement Objective: 

Proposed Measures: We are proposing 

that providers must attest to the 

numerator and denominator for all three 

measures, but would only be required to 

successfully meet the threshold for two 

of the three proposed measures to meet 

the Coordination of Care through Patient 

Engagement Objective. These three 

measures support the communication 

continuum between providers, patients, 

and the patient’s authorized 

representatives through the use of view, 

download, and transmit functionality. 

They also support using API 

functionality through patient 

engagement with their health data, but 

also potentially through secure 

messaging functions and standards, and 

the capture and inclusion of data 

collected from non-clinical settings, 

including patient-generated health data. 

Proposed Measure 1: During the EHR 

reporting period, more than 25 percent 

of all unique patients seen by the EP or 

discharged from the eligible hospital or 

CAH inpatient or emergency department 

(POS 21 or 23) actively engage with the 

electronic health record made accessible 

by the provider. An EP, eligible hospital 

or CAH may meet the measure by either: 

(1) More than 25 percent of all unique 

patients (or patient-authorized 

representatives) seen by the EP or 

discharged from the eligible hospital or 

CAH inpatient or emergency department 

(POS 21 or 23) during the EHR reporting 

period view, download or transmit to a 

third party their health information; or 

(2) More than 25 percent of all unique 

patients (or patient-authorized 

representatives) seen by the EP or 

discharged from the eligible hospital or 

CAH inpatient or emergency department 

(POS 21 or 23) during the EHR reporting 

period access their health information 

through the use of an ONC-certified API 

that can be used by third-party 

applications or devices. 

Proposed Measure 2: For more than 

35 percent of all unique patients seen by 

the EP or discharged from the eligible 

hospital or CAH inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period, a secure message 

was sent using the electronic messaging 

function of CEHRT to the patient (or the 

patient’s authorized representatives), or 

in response to a secure message sent by 

the patient (or the patient’s authorized 

representative). 

Proposed Measure 3: Patientgenerated health data or data from a 

non-clinical setting is incorporated into 

the certified EHR technology for more 

than 15 percent of all unique patients 

seen by the EP or discharged by the 

eligible hospital or CAH inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period. 

For measure 1, we are proposing to 

increase the threshold for the measure 

from 5 percent to 25 percent based on 

provider performance on the related 

Stage 2 measure requiring more than 5 

percent of patients to view, download, 

or transmit to a third party the health 

information made available to them by 

the provider. Stage 2 median 

performance for an EP on this measure 

is 32 percent and 11 percent for eligible 

hospitals.11 Therefore, we are proposing 

more than 25 percent of all unique 

patients (or the patient’s authorized 

representatives) seen by the EP, eligible 

hospital or CAH during the EHR 

reporting period must view, download, 

or transmit to a third party their health 

information or access their health 

information through the use of an ONCcertified API that can be used by thirdparty applications or devices. For the 

API option, we propose that providers 

must attest that they have enabled an 

API and that at least one application 

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which leverages the API is available to 

patients (or the patient-authorized 

representatives) to retrieve health 

information from the provider’s certified 

EHR. 

CMS recognizes that there may be 

inherent challenges in measuring 

patient access to CEHRT through thirdparty applications that utilize an ONCcertified API, and we solicit comment 

on the nature of those challenges and 

what solutions can be put in place to 

overcome them. For example, are there 

specific requirements around the use of 

APIs or are there specific certification 

requirements for APIs that could make 

the measurement of this objective easier. 

We also solicit comment on suggested 

alternate proposals for measuring 

patient access to CEHRT through thirdparty applications that utilize an API, 

including the pros and cons of 

measuring a minimum number of 

patients (one or more) who must access 

their health information through the use 

of an API in order to meet the measure 

of this objective. 

For measure 2, the EP, eligible 

hospital, CAH, or the provider’s 

authorized representative must 

communicate with the patient (or the 

patient’s authorized representatives), 

through secure electronic messaging for 

more than 35 percent of the unique 

patients seen by the provider during the 

EHR reporting period. ‘‘Communicate’’ 

means when a provider sends a message 

to a patient (or the patient’s authorized 

representatives) or when a patient (or 

the patient’s authorized representatives) 

sends a message to the provider. In 

patient-to-provider communication, the 

provider must respond to the patient (or 

the patient’s authorized representatives) 

for purposes of this measure. We 

propose to increase the threshold for 

this measure over the threshold for the 

Stage 2 measure because for Stage 3 

provider initiated messages would 

count toward the measure numerator. 

For measure 2, we propose to include 

in the measure numerator situations 

where providers communicate with 

other care team members using the 

secure messaging function of certified 

EHR technology, and the patient is 

engaged in the message and has the 

ability to be an active participant in the 

conversation between care providers. 

However, we seek comment on how this 

action could be counted in the 

numerator, and the extent to which that 

interaction could or should be counted 

for eligible providers engaged in the 

communication. For example, should 

only the initiating provider be allowed 

to include the communication as an 

action in the numerator? Or, should any 

provider who contributes to such a 

message during the EHR reporting 

period be allowed to count the 

communication? In addition, we seek 

comment on what should be considered 

a contribution to the patient-centered 

communication; for example, a 

contribution must be active 

participation or response, a contribution 

may be viewing the communication, or 

a contribution may be simple inclusion 

in the communication. 

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 provider is the 

best judge of what health information 

should be considered relevant in this 

context. For the purposes of this 

measure, we are proposing that secure 

messaging content may include, but is 

not limited to, questions about test 

results, problems, and medications; 

suggestions for follow-up care or 

preventative screenings; confirmations 

of diagnosis and care plan goals; and 

information regarding patient progress. 

However, we note that messages with 

content exclusively relating to billing 

questions, appointment scheduling, or 

other administrative subjects should not 

be included in the numerator. For care 

team secure messaging with the patient 

included in the conversation, we also 

believe the provider may exercise 

discretion if further communications 

resulting from the initial action should 

be excluded from patient disclosure to 

prevent harm. We note that if such a 

message is excluded, all subsequent 

actions related to that message would 

not count toward the numerator. 

For measure 3, EPs, eligible hospitals, 

and CAHs (or their authorized 

representatives) must incorporate health 

data obtained from a non-clinical setting 

in a patient’s electronic health record 

for more than 15 percent of unique 

patients seen during the EHR reporting 

period. We note that the use of the term 

‘‘clinical’’ means different things in 

relation to place of service for billing for 

Medicare and Medicaid services. 

However, for purposes of this measure 

only, we are proposing that a nonclinical setting shall be defined as a 

setting with any provider who is not an 

EP, eligible hospital or CAH as defined 

for the Medicare and Medicaid EHR 

Incentive Programs. Therefore, for this 

measure, a non-clinical setting is any 

provider or setting of care which is not 

an EP, eligible hospital, or CAH in 

either the Medicare or Medicaid EHR 

Incentive Programs and where the care 

provider does not have shared access to 

the EP, eligible hospital, or CAHs 

certified EHR. This may include, but is 

not limited to, health and care-related 

data from care providers such as 

nutritionists, physical therapists, 

occupational therapists, psychologists, 

and home health care providers as well 

as data obtained from patients 

themselves. We specifically mention 

this last item and refer to this subcategory as patient-generated health 

data, which may result from patient selfmonitoring of their health (such as 

recording vital signs, activity and 

exercise, medication intake, and 

nutrition), either on their own, or at the 

direction of a member of the care team. 

We are proposing this measure in 

response to requests from providers to 

support the capture and incorporation 

of patient-generated health data, and the 

capture and incorporation of data from 

a non-clinical setting into an EHR. 

Providers have expressed a desire to 

have this information captured in a 

useful and structured way and made 

available in the EHR. The capture and 

incorporation of this information is an 

integral part of ensuring that providers 

and patients have adequate information 

to partner in making clinical care 

decisions, especially for patients with 

chronic disease and complex health 

conditions for whom self-monitoring is 

an important part of an ongoing care 

plan. 

We are seeking comment on how the 

information for measure 3 could be 

captured, standardized, and 

incorporated into an EHR. For the 

purposes of this measure, the types of 

data that would satisfy the measure is 

broad. It may include, but is not limited 

to social service data, data generated by 

a patient or a patient’s authorized 

representatives, advance directives, 

medical device data, home health 

monitoring data, and fitness monitor 

data. In addition, the sources of data 

vary and may include mobile 

applications for tracking health and 

nutrition, home health devices with 

tracking capabilities such as scales and 

blood pressure monitors, wearable 

devices such as activity trackers or heart 

monitors, patient reported outcome 

data, and other methods of input for 

patient and non-clinical setting 

generated health data. We emphasize 

that these represent several examples of 

the data types that could be covered 

under this measure. We also note that 

while the scope of data covered by this 

measure is broad, it may not include 

data related to billing, payment, or other 

insurance information. As part of 

determining the proper scope of this 

measure, we are seeking comment on 

the following questions: 

• Should the data require verification 

by an authorized provider? 

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• Should the incorporation of the 

data be automated? 

• Should there be structured data 

elements available for this data as fields 

in an EHR? 

• Should the data be incorporated in 

the CEHRT with or without provider 

verification? 

• Should the provenance of the data 

be recorded in all cases and for all types 

of data? 

We also seek comment on whether 

this proposed measure should have a 

denominator limited to patients with 

whom the provider has multiple 

encounters, such as unique patients 

seen by the provider two or more times 

during the EHR reporting period. We 

also seek comment on whether this 

measure should be divided into two 

distinct measures. The first measure 

would include only the specific subcategory of patient-generated health 

data, or data generated predominantly 

through patient self-monitoring rather 

than by a provider. The second measure 

would include all other data from a nonclinical setting. This would result in the 

objective including four measures with 

providers having an option of which 

two measures to focus on for the EHR 

reporting period. 

We also seek comment on whether the 

third measure should be proposed for 

eligible hospitals and CAHs, or remain 

an option only for eligible professionals. 

For those commenters who believe it 

should not be applicable for eligible 

hospitals and CAHs, we seek further 

comment on whether eligible hospitals 

and CAHs should then choose one of 

the remaining two measures or be 

required to attest to both. 

Providers must attest to the numerator 

and denominator for all three measures, 

and must meet the threshold for two of 

the three measures to meet the objective 

for Stage 3 of meaningful use: 

Proposed Measure 1: We have 

identified the following for measure 1 of 

this objective: 

Option 1: View, Download, or Transmit 

to a Third Party 

Denominator: Number of unique 

patients seen by the EP, or the number 

of unique patients discharged from an 

eligible hospital or CAH inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period. 

Numerator: The number of unique 

patients (or their authorized 

representatives) in the denominator who 

have viewed online, downloaded, or 

transmitted to a third party the patient’s 

health information. 

Threshold: The resulting percentage 

must be more than 25 percent in order 

for an EP, eligible hospital, or CAH to 

meet this measure. 

Option 2: API 

Denominator: The number of unique 

patients seen by the EP or the number 

of unique patients discharged from an 

eligible hospital or CAH inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period. 

Numerator: The number of unique 

patients (or their authorized 

representatives) in the denominator who 

have accessed their health information 

through the use of an an ONC-certified 

API. 

Threshold: The resulting percentage 

must be more than 25 percent in order 

for an EP, eligible hospital, or CAH to 

meet this measure. 

Exclusions: Applicable for either 

option discussed previously, the 

following providers may exclude from 

the measure: 

Any EP who has no office visits 

during the EHR reporting period may 

exclude from the measure. 

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 from the 

measure. 

Any eligible hospital or CAH 

operating in a location 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 from the measure. 

Measure 2: Denominator: Number of 

unique patients seen by the EP or the 

number of unique patients discharged 

from an eligible hospital or CAH 

inpatient or emergency department 

(POS 21 or 23) during the EHR reporting 

period. 

Numerator: The number of patients in 

the denominator for whom a secure 

electronic message is sent to the patient, 

the patient’s authorized representatives, 

or in response to a secure message sent 

by the patient. 

Threshold: The resulting percentage 

must be more than 35 percent in order 

for an EP, eligible hospital, or CAH to 

meet this measure. 

Exclusion: Any EP who has no office 

visits during the EHR reporting period 

may exclude from the measure. 

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 from the 

measure. 

Any eligible hospital or CAH 

operating in a location 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 from the measure. 

Measure 3: Denominator: Number of 

unique patients seen by the EP or the 

number of unique patients discharged 

from an eligible hospital or CAH 

inpatient or emergency department 

(POS 21 or 23) during the EHR reporting 

period. 

Numerator: The number of patients in 

the denominator for whom data from 

non-clinical settings, which may 

include patient-generated health data, is 

captured through the certified EHR 

technology into the patient record. 

Threshold: The resulting percentage 

must be more than 15 percent in order 

for an EP, eligible hospital, or CAH to 

meet this measure. 

Exclusion: Any EP who has no office 

visits during the EHR reporting period 

may exclude from the measure. 

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 from the 

measure. 

Any eligible hospital or CAH 

operating in a location 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 from the measure. 

We seek comment on this proposed 

objective and the related proposed 

measures. 

Objective 7: Health Information 

Exchange 

Improved communication between 

providers caring for the same patient 

can help providers make more informed 

care decisions and coordinate the care 

they provide. Electronic health records 

and the electronic exchange of health 

information, either directly or through 

health information exchanges, can 

reduce the burden of such 

communication. The purpose of this 

objective is to ensure a summary of care 

record is transmitted or captured 

electronically and incorporated into the 

EHR for patients seeking care among 

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different providers in the care 

continuum, and to encourage 

reconciliation of health information for 

the patient. This objective promotes 

interoperable systems and supports the 

use of CEHRT to share information 

among care teams. 

Proposed Objective: The EP, eligible 

hospital, or CAH provides a summary of 

care record when transitioning or 

referring their patient to another setting 

of care, retrieves a summary of care 

record upon the first patient encounter 

with a new patient, and incorporates 

summary of care information from other 

providers into their EHR using the 

functions of certified EHR technology. 

In the Stage 2 final rule at 77 FR 

53983, we described transitions of care 

as the movement of a patient from one 

setting of care (hospital, ambulatory 

primary care practice, ambulatory 

specialty care practice, long-term care, 

home health, rehabilitation facility) to 

another. Referrals are cases where one 

provider refers a patient to another 

provider, but the referring provider also 

continues to provide care to the patient. 

In this rule, we also recognize there may 

be circumstances when a patient refers 

himself or herself to a setting of care 

without a provider’s prior knowledge or 

intervention. These referrals may be 

included as a subset of the existing 

referral framework and they are an 

important part of the care coordination 

loop for which summary of care record 

exchange is integral. Therefore, a 

provider should include these instances 

in their denominator for the measures if 

the patient subsequently identifies the 

provider from whom they received care. 

In addition, the provider may count 

such a referral in the numerator for each 

measure if they undertake the action 

required to meet the measure upon 

disclosure and identification of the 

provider from whom the patient 

received care. 

In the Stage 2 final rule, we indicated 

that a transition or referral within a 

single setting of care does not qualify as 

a transition of care (77 FR 53983). We 

received public comments and 

questions requesting clearer 

characterization of when a setting of 

care can be considered distinct from 

another setting of care. For example, 

questions arose whether EPs who work 

within the same provider practice are 

considered the same or two distinct 

settings of care. Similarly, questions 

arose whether an EP who practices in an 

outpatient setting that is affiliated with 

an inpatient facility is considered a 

separate entity. Therefore, for the 

purposes of distinguishing settings of 

care in determining the movement of a 

patient, we explain that for a transition 

or referral, it must take place between 

providers which have, at the minimum, 

different billing identities within the 

EHR Incentive Programs, such as a 

different National Provider Identifiers 

(NPI) or hospital CMS Certification 

Numbers (CCN) to count toward this 

objective. 

Please note that a ‘‘referral’’ as 

defined here and elsewhere in this 

proposed rule only applies to the EHR 

Incentive Programs and is not 

applicable to other federal regulations. 

We stated in the Stage 2 proposed rule 

at 77 FR 13723 that if the receiving 

provider has access to the medical 

record maintained by the provider 

initiating the transition or referral, then 

the summary of care record would not 

need to be provided and that patient 

may be excluded from the denominators 

of the measures for the objective. We 

further note that this access may vary 

from read-only access of a specific 

record, to full access with authoring 

capabilities, depending on provider 

agreements and system implementation 

among practice settings. In many cases, 

a clinical care summary for transfers 

within organizations sharing access to 

an EHR may not be necessary, such as 

a hospital sharing their CEHRT with 

affiliated providers in ambulatory 

settings who have full access to the 

patient information. However, public 

comments received and questions 

submitted by the public on the Stage 2 

Summary of Care Objective reveal that 

there may be benefits to the provision of 

a summary of care document following 

a transition or referral of a patient, even 

when access to medical records is 

already available. For example, a 

summary of care document would 

notify the receiving provider of relevant 

information about the latest patient 

encounter as well as highlight the most 

up-to-date information. In addition, the 

‘‘push’’ of a summary of care document 

may function as an alert to the recipient 

provider of the transition that a patient 

has received care elsewhere and would 

encourage the provider to review a 

patient’s medical record for follow-up 

care or reconciliation of clinical 

information. 

Therefore, we are revising this 

objective for Stage 3 to allow the 

inclusion of transitions of care and 

referrals in which the recipient provider 

may already have access to the medical 

record maintained in the referring 

provider’s CEHRT, as long as the 

providers have different billing 

identities within the EHR Incentive 

Program. We note that for a transition or 

referral to be included in the numerator, 

if the receiving provider already has 

access to the CEHRT of the initiating 

provider of the transition or referral, 

simply accessing the patient’s health 

information does not count toward 

meeting this objective. However, if the 

initiating provider also sends a 

summary of care document, this 

transition can be included in the 

denominator and the numerator, as long 

as this transition is counted consistently 

across the organization. 

Proposed Measures: We are proposing 

that providers must attest to the 

numerator and denominator for all three 

measures, but would only be required to 

successfully meet the threshold for two 

of the three proposed measures to meet 

the Health Information Exchange 

Objective. 

Proposed Measure 1: For more than 

50 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: (1) creates a summary 

of care record using CEHRT; and (2) 

electronically exchanges the summary 

of care record. 

Proposed Measure 2: For more than 

40 percent of transitions or referrals 

received and patient encounters in 

which the provider has never before 

encountered the patient, the EP, eligible 

hospital or CAH incorporates into the 

patient’s EHR an electronic summary of 

care document from a source other than 

the provider’s EHR system. 

Proposed Measure 3: For more than 

80 percent of transitions or referrals 

received and patient encounters in 

which the provider has never before 

encountered the patient, the EP, eligible 

hospital, or CAH performs a clinical 

information reconciliation. The provider 

must implement clinical information 

reconciliation for the following three 

clinical information sets: 

• Medication. Review of the patient’s 

medication, including the name, dosage, 

frequency, and route of each 

medication. 

• Medication allergy. Review of the 

patient’s known allergic medications. 

• Current Problem list. Review of the 

patient’s current and active diagnoses. 

For the first measure, we are 

maintaining the requirements 

established in the Stage 2 final rule to 

capture structured data within the 

certified EHR and to generate a 

summary of care document using 

CEHRT for purposes of this measure (77 

FR 54014). For purposes of this 

measure, we are requiring that the 

summary of care document created by 

CEHRT be sent electronically to the 

receiving provider. 

In the Stage 2 final rule at 77 FR 

54016, we specified all summary of care 

documents must include the following 

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information in order to meet the 

objective, if the provider knows it: 

• Patient name. 

• Referring or transitioning provider’s 

name and office contact information (EP 

only). 

• Procedures. 

• Encounter diagnosis. 

• Immunizations. 

• Laboratory test results. 

• Vital signs (height, weight, blood 

pressure, BMI). 

• Smoking status. 

• Functional status, including 

activities of daily living, cognitive and 

disability status. 

• Demographic information 

(preferred language, sex, race, ethnicity, 

date of birth). 

• Care plan field, including goals and 

instructions. 

• Care team including the primary 

care provider of record and any 

additional known care team members 

beyond the referring or transitioning 

provider and the receiving provider. 

• Discharge instructions (Hospital 

Only). 

• Reason for referral (EP only). 

For the 2015 Edition proposed rule, 

ONC has proposed a set of criteria 

called the Common Clinical Data Set 

which include the required elements for 

the summary of care document, the 

standards required for structured data 

capture of each, and further definition 

of related terminology and use. 

Therefore, for Stage 3 of meaningful use 

we are proposing that summary of care 

documents used to meet the Stage 3 

Health Information Exchange objective 

must include the requirements and 

specifications included in the Common 

Clinical Data Set (CCDS) specified by 

ONC for certification to the 2015 Edition 

proposed rule published elsewhere in 

this issue of the Federal Register. 

We note that ONC’s 2015 Edition 

proposed rule may include additional 

fields beyond those initially required for 

Stage 2 of meaningful use as new 

standards have been developed to 

accurately capture vital information on 

patient health. For example, the 2015 

Edition proposed rule includes a 

criterion and standard for capturing the 

unique device identifier (UDI) for 

implantable medical devices. The 

inclusion of the UDI in the CCDS 

reflects the understanding that UDIs are 

an important part of patient information 

that should be exchanged and available 

to providers who care for patients with 

implanted medical devices. Hundreds of 

thousands of Medicare beneficiaries 

receive some type of implantable 

medical device each year. Some 

implants require ongoing monitoring 

and medication for the device to 

perform effectively, such as a 

mechanical heart valve. Other 

implanted devices are affected by 

imaging procedures and are not MRI 

safe such as some pace makers. Even the 

variation between specific makes and 

models of similar devices may impact 

the clinical processes required to 

mitigate against patient safety risk. 

Without readily available data, the 

patient is put at risk if the provider does 

not have adequate knowledge of the 

existence and specific details of medical 

implants. Therefore, the documentation 

of UDIs in a patient medical record and 

the inclusion of that data field within 

the CCDS requirements for the summary 

of care documents is a key step toward 

improving the quality of care and 

ensuring patient safety. This example 

highlights the importance of capturing 

health data in a structured format using 

specified, transferable standards. 

In circumstances where there is no 

information available to populate one or 

more of the fields included in the CCDS, 

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 blank and still meet the 

requirements for the measure. 

However, all summary of care 

documents used to meet this objective 

must be populated with the following 

information using the CCDS 

certification standards for those fields: 

• Current problem list (Providers may 

also include historical problems at their 

discretion). 

• A current medication list. 

• A current medication allergy list. 

We define allergy as an exaggerated 

immune response or reaction to 

substances that are generally not 

harmful. Information on problems, 

medications, and medication allergies 

could be obtained from previous 

records, transfer of information from 

other providers (directly or indirectly), 

diagnoses made by the EP or hospital, 

new medications ordered by the EP or 

in the hospital, or through querying the 

patient. 

We propose to maintain that all 

summary of care documents contain the 

most recent and up-to-date information 

on all elements. In the event that there 

are no current diagnoses for a patient, 

the patient is not currently taking any 

medications, or the patient has no 

known medication allergies; the EP, 

eligible hospital, or CAH must record or 

document within the required fields 

that there are no problems, no 

medications, or no medication allergies 

recorded for the patient to satisfy the 

measure of this objective. The EP or 

hospital must verify that the 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. 

For summary of care documents at 

transitions of care, we encourage 

providers to send a list of items that he 

or she believes to be pertinent and 

relevant to the patient’s care, rather than 

a list of all problems, whether active or 

resolved, that have ever populated the 

problem list. While a current problem 

list must always be included, the 

provider can use his or her judgment in 

deciding which items historically 

present on the problem list, medical 

history list (if it exists in CEHRT), or 

surgical history list are relevant given 

the clinical circumstances. 

Similarly, for Stage 3 we have 

received comments from stakeholders 

and through public forums and 

correspondence on the potential of 

allowing only clinically relevant 

laboratory test results and clinical notes 

(rather than all laboratory tests results 

and clinical notes) in the summary of 

care document for purposes of meeting 

the objective. We believe that while 

there may be a benefit and efficiency to 

be gained in the potential to limit 

laboratory test results or clinical notes 

to those most relevant for a patient’s 

care; a single definition of clinical 

relevance may not be appropriate for all 

providers, all settings, or all individual 

patient diagnosis. Furthermore, we note 

that should a reasonable limitation 

around a concept of ‘‘clinical relevance’’ 

be added; a provider must still have the 

CEHRT functionality to include and 

send all labs or clinical notes. Therefore, 

we defer to provider discretion on the 

circumstances and cases wherein a 

limitation around clinical relevance 

may be beneficial and note that such a 

limitation would be incumbent on the 

provider to define and develop in 

partnership with their health IT 

developer as best fits their 

organizational needs and patient 

population. We specify that while the 

provider has the discretion to define the 

relevant clinical notes or relevant 

laboratory results to send as part of the 

summary of care record, providers must 

be able to provide all clinical notes or 

laboratory results through an electronic 

transmission of a summary of care 

document if that level of detail is 

subsequently requested by a provider 

receiving a transition of care or referral 

or the patient is transitioning to another 

setting of care. We note that this 

proposal would apply for lab results, 

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clinical notes, problem lists, and the 

care plan within the summary of care 

document. 

For the second measure, we are 

proposing to address the other end of 

the transition of care continuum. In the 

Stage 2 rule, we limited the action 

required by providers to sending an 

electronic transmission of a summary of 

care document. We did not have a 

related requirement for the recipient of 

that transmission. We did not adopt a 

certification requirement for the 

receiving end of a transition or referral 

or for the measure related to sending the 

summary, as that is a factor outside the 

sending provider’s immediate control. 

However, in Stage 3 of meaningful use, 

we are proposing a measure for the 

provider as the recipient of a transition 

or referral requiring them to actively 

seek to incorporate an electronic 

summary of care document into the 

patient record when a patient is referred 

to them or otherwise transferred into 

their care. This proposal is designed to 

complete the electronic transmission 

loop and support providers in using 

CEHRT to support the multiple roles a 

provider plays in meaningful health 

information exchange. 

For the purposes of defining the cases 

in the denominator, we are proposing 

that what constitutes ‘‘unavailable’’ and 

therefore, may be excluded from the 

denominator, will be that a provider— 

• Requested an electronic summary of 

care record to be sent and did not 

receive an electronic summary of care 

document; and 

• Queried at least one external source 

via HIE functionality and did not locate 

a summary of care for the patient, or the 

provider does not have access to HIE 

functionality to support such a query. 

We seek comment on whether 

electronic alerts received by EPs from 

hospitals when a patient is admitted, 

seen in the emergency room or 

discharged from the hospital—so called 

‘‘utilization alerts’’—should be included 

in measure two, or as a separate 

measure. Use of this form of health 

information exchange is increasingly 

rapidly, driven by hospital and EP 

efforts to improve care transitions and 

reduce readmissions. We also seek 

comment on which information from a 

utilization alert would typically be 

incorporated into a patient’s record and 

how this is done today. 

For both the first and second 

measures, we are proposing that a 

provider may use a wide range of health 

IT system for health information 

exchange to receive or send an 

electronic summary of care document, 

but must use their certified EHR 

technology to create the summary of 

care document sent or to incorporate the 

summary of care document received 

into the patient record. We are also 

proposing that the receipt of the 

summary of care document (CCDA) may 

be passive (provider is sent the CCDA 

and incorporates it) or active (provider 

requests a direct transfer of the CCDA or 

provider queries an HIE for the CCDA). 

In the Stage 2 proposed rule, we noted 

the benefits of requiring standards for 

the transport mechanism for health 

information exchange consistently 

nationwide (77 FR 13723). We requested 

public comment in that proposed rule 

on the Nationwide Health Information 

Network specifications and a 

governance mechanism for health 

information exchange to be established 

by ONC. In the final rule, a governance 

mechanism option was included in the 

second measure for the Stage 2 

summary of care objective at 77 FR 

54020. In this Stage 3 proposed rule, we 

again seek comment on a health 

information exchange governance 

mechanism. Specifically we seek 

comment on whether providers who 

create a summary of care record using 

CEHRT for purposes of Measure 1 

should be permitted to send the created 

summary of care record either—(1) 

through any electronic means; or (2) in 

a manner that is consistent with the 

governance mechanism ONC establishes 

for the nationwide health information 

network. We additionally seek comment 

on whether providers who are receiving 

a summary of care record using CEHRT 

for the purposes of Measure 2 should 

have a similar requirement for the 

transport of summary of care documents 

requested from a transitioning provider. 

Finally, we seek comment on how a 

governance mechanism established by 

ONC at a later date could be 

incorporated into the EHR Incentive 

Programs for purposes of encouraging 

interoperable exchange that benefits 

patients and providers, including how 

the governance mechanism should be 

captured in the numerator, 

denominator, and thresholds for both 

the first (send) and second (receive) 

measures of this Health Information 

exchange objective. 

For the third measure, we are 

proposing a measure of clinical 

information reconciliation which 

incorporates the Stage 2 objective for 

medication reconciliation and expands 

the options to allow for the 

reconciliation of other clinical 

information such as medication 

allergies, and problems which will 

allow providers additional flexibility in 

meeting the measure in a way that is 

relevant to their scope of practice. In the 

Stage 2 final rule, we outlined the 

benefits of medication reconciliation, 

which enables providers to validate that 

the patient’s list of active medications is 

accurate (77 FR 54011 through 54012). 

This activity improves patient safety, 

improves care quality, and improves the 

validity of information that the provider 

shares with others through health 

information exchange. We believe that 

reconciliation of medication allergies 

and problems affords similar benefits. 

For this proposed measure, we specify 

that the EP, eligible hospital, or CAH 

that receives the patient into their care 

should conduct the clinical information 

reconciliation. It is for the receiving 

provider that up-to-date information 

will be most crucial to make informed 

clinical judgments for patient care. We 

reiterate that this measure does not 

dictate what subset of information must 

be included in reconciliation. 

Information included in the process is 

determined by the provider’s clinical 

judgment of what is most relevant to 

patient care. 

For this measure, we propose to 

define clinical information 

reconciliation as the process of creating 

the most accurate patient-specific 

information in one or more of the 

specified categories by using the clinical 

information reconciliation capability of 

their certified EHR technology which 

will compare the ‘‘local’’ information to 

external/incoming information that is 

being incorporated into the certified 

EHR technology from any external 

source. We refer providers to the 

standards and certification criteria for 

clinical information reconciliation 

proposed in ONC’s 2015 Edition 

proposed rule published elsewhere in 

this issue of the Federal Register. 

As with medication reconciliation, we 

believe that an electronic exchange of 

information following the transition of 

care of a patient is the most efficient 

method of performing clinical 

information reconciliation. 

We recognize that workflows to 

reconcile clinical information vary 

widely across providers and settings of 

care, and we request comment on the 

challenges that this objective might 

present for providers, and how such 

challenges might be mitigated, while 

preserving the policy intent of the 

measure. In particular, we solicit 

comment on the following: 

• Automation and Manual 

Reconciliation. The Stage 2 measure 

does not specify whether reconciliation 

must be automated or manual. Some 

providers have expressed concern over 

the automatic inclusion of data in the 

patient record from referring providers, 

while others have indicated that 

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requiring manual reconciliation imposes 

significant workflow burden. We also 

seek comment on whether the use and 

display of meta-tagged data could 

address concerns related to the origin of 

data and thereby permit more 

automated reconciliation of these data 

elements. 

• Review of Reconciled Information. 

Depending on clinical setting, this 

measure could be accomplished through 

manual reconciliation or through 

automated functionality. In either 

scenario, should the reconciliation or 

review of automated functionality be 

performed only by the same staff 

allowed under the Stage 3 requirements 

for the Computerized Provider Order 

Entry objective? 

• What impact would the 

requirement of clinical information 

reconciliation have on workflow for 

specialists? Are there particular 

specialties where this measure would be 

difficult to meet? 

• What additional exclusions, if any, 

should be considered for this measure? 

We also encourage comment on the 

proposal to require reconciliation of all 

three clinical information reconciliation 

data sets, or if we should potentially 

require providers to choose 2 of 3 

information reconciliation data sets 

relevant to their specialty or patient 

population. We expect that most 

providers would find that conducting 

clinical information reconciliation for 

medications, medication allergies, and 

problem lists is relevant for every 

patient encountered. We solicit 

examples describing challenges and 

burdens that providers who deliver 

specialist care or employ unique clinical 

workflow practices may experience in 

completing clinical information 

reconciliation for all three data sets and 

whether an exclusion should be 

considered for providers for whom such 

reconciliation may not be relevant to 

their scope of practice or patient 

population. Additionally, we solicit 

comments around the necessity to 

conduct different types of clinical 

information reconciliation of data for 

each individual patient. For example, it 

is possible that the data for certain 

patients should always be reviewed for 

medication allergy reconciliation, when 

it may not be as relevant to other patient 

populations. 

We propose that to meet this 

objective, a provider must attest to the 

numerator and denominator for all three 

measures but would only be required to 

successfully meet the threshold for two 

of the three proposed measures. We 

invite public comment on this proposal. 

Measure 1: To calculate the 

percentage of the first measure, CMS 

and ONC have worked together to 

define the following for this measure: 

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 

created using certified EHR technology 

and exchanged electronically. 

Threshold: The percentage must be 

more than 50 percent in order for an EP, 

eligible hospital, or CAH to meet this 

measure. 

Exclusion: An EP neither transfers a 

patient to another setting nor refers a 

patient to another provider during the 

EHR reporting period. 

* 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 the 

measures. 

Any eligible hospital or CAH will be 

excluded from the 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. 

Measure 2: To calculate the 

percentage of the second measure, CMS 

and ONC have worked together to 

define the following for this measure: 

Denominator: Number of patient 

encounters during the EHR reporting 

period for which an EP, eligible 

hospital, or CAH was the receiving party 

of a transition or referral or has never 

before encountered the patient and for 

which an electronic summary of care 

record is available. 

Numerator: Number of patient 

encounters in the denominator where an 

electronic summary of care record 

received is incorporated by the provider 

into the certified EHR technology. 

Threshold: The percentage must be 

more than 40 percent in order for an EP, 

eligible hospital, or CAH to meet this 

measure. 

Exclusion: Any EP, eligible hospital or 

CAH for whom the total of transitions or 

referrals received and patient 

encounters in which the provider has 

never before encountered the patient, is 

fewer than 100 during the EHR 

reporting period is excluded from this 

measure. 

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 the 

measures. 

Any eligible hospital or CAH will be 

excluded from the 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. 

Measure 3: To calculate the 

percentage, CMS and ONC have worked 

together to define the following for this 

measure: 

Denominator: Number of transitions 

of care or 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 recipient of the transition or 

referral or has never before encountered 

the patient. 

Numerator: The number of transitions 

of care or referrals in the denominator 

where the following three clinical 

information reconciliations were 

performed: medication list, medication 

allergy list, and current problem list. 

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 for whom the total of transitions or 

referrals received and patient 

encounters in which the provider has 

never before encountered the patient, is 

fewer than 100 during the EHR 

reporting period is excluded from this 

measure. 

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 the 

measure. 

Any eligible hospital or CAH will be 

excluded from the 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. 

We welcome comment on these 

proposals. 

Objective 8: Public Health and 

Clinical Data Registry Reporting 

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This objective builds on the 

requirements set forth in the Stage 2 

final rule (77 FR 54021 through 54026). 

In addition, this objective includes 

improvements to the Stage 2 measures, 

supports innovation that has occurred 

since the Stage 2 rule was released, and 

adds flexibility in the options that an 

eligible provider has to successfully 

report. 

Further, this objective places 

increased focus on the importance of the 

ongoing lines of communication that 

should exist between providers and 

public health agencies (PHAs) or as 

further discussed later in this section, 

between providers and clinical data 

registries (CDRs). Providers’ use of 

certified EHR technology can increase 

the flow of secure health information 

and reduce the burden that otherwise 

could attach to these important 

communications. The purpose of this 

Stage 3 objective is to further advance 

communication between providers and 

PHAs or CDRs, as well as strengthen the 

capture and transmission of such health 

information within the care continuum. 

In this Stage 3 proposed rule, we are 

proposing changes to the Stage 1 and 

Stage 2 public health and specialty 

registry objectives to consolidate the 

prior objectives and measures into a 

single objective in alignment with 

efforts to streamline the program and 

support flexibility for providers. We 

propose to include a new measure for 

case reporting to reflect the diverse 

ways that providers can electronically 

exchange data with PHAs and CDRs. In 

addition, we are using new terms such 

as public health registries and clinical 

data registries to incorporate the Stage 2 

designations for cancer registries and 

specialized registries under these 

categories which are used in the health 

care industry to designate a broader 

range of registry types. We further 

explain the use of these terms within 

the specifications outlined for each 

applicable measure. 

Proposed Objective: The EP, eligible 

hospital, or CAH is in active 

engagement with a PHA or CDR to 

submit electronic public health data in 

a meaningful way using certified EHR 

technology, except where prohibited, 

and in accordance with applicable law 

and practice. 

For Stage 3, we are proposing to 

remove the prior ‘‘ongoing submission’’ 

requirement and replace it with an 

‘‘active engagement’’ requirement. 

Depending on the measure, the ongoing 

submission requirement from the Stage 

1 and Stage 2 final rules required the 

successful ongoing submission of 

applicable data from certified EHR 

technology to a PHA or CDR for the 

entire EHR reporting period. As part of 

the Stage 2 final rule, we provided 

examples demonstrating how ongoing 

submission could satisfy the measure 

(77 FR 54021). However, stakeholders 

noted that the ongoing submission 

requirement does not accurately capture 

the nature of communication between 

providers and a PHA or CDR, and does 

not consider the many steps necessary 

to arrange for registry submission to a 

PHA or CDR. Given this feedback, we 

believe that ‘‘active engagement’’ as 

defined later in this section is more 

aligned with the process providers 

undertake to report to a CDR or to a 

PHA. 

For purposes of meeting this new 

objective, EPs, eligible hospitals and 

CAHs would be required to demonstrate 

that ‘‘active engagement’’ with a PHA or 

CDR has occurred. Active engagement 

means that the provider is in the process 

of moving towards sending ‘‘production 

data’’ to a PHA or CDR, or— is sending 

production data to a PHA or CDR. We 

note that the term ‘‘production data’’ 

refers to data generated through clinical 

processes involving patient care, and it 

is here used to distinguish between this 

data and ‘‘test data’’ which may be 

submitted for the purposes of enrolling 

in and testing electronic data transfers. 

We propose that ‘‘active engagement’’ 

may be demonstrated by any of the 

following options: 

Active Engagement Option 1— 

Completed Registration to Submit Data: 

The EP, eligible hospital, or CAH 

registered to submit data with the PHA 

or, where applicable, the CDR to which 

the information is being submitted; 

registration was completed within 60 

days after the start of the EHR reporting 

period; and the EP, eligible hospital, or 

CAH is awaiting an invitation from the 

PHA or CDR to begin testing and 

validation. This option allows providers 

to meet the measure when the PHA or 

the CDR has limited resources to initiate 

the testing and validation process. 

Providers that have registered in 

previous years do not need to submit an 

additional registration to meet this 

requirement for each EHR reporting 

period. 

Active Engagement Option 2—Testing 

and Validation: The EP, eligible 

hospital, or CAH is in the process of 

testing and validation of the electronic 

submission of data. Providers must 

respond to requests from the PHA or, 

where applicable, the CDR within 30 

days; failure to respond twice within an 

EHR reporting period would result in 

that provider not meeting the measure. 

Active Engagement Option 3— 

Production: The EP, eligible hospital, or 

CAH has completed testing and 

validation of the electronic submission 

and is electronically submitting 

production data to the PHA or CDR. 

We also propose to provide support to 

providers seeking to meet the 

requirements of this objective by 

creating a centralized repository of 

national, state, and local PHA and CDR 

readiness. In the Stage 2 final rule (77 

FR 54021), we noted the benefits of 

developing a centralized repository 

where a PHA could post readiness 

updates regarding their ability to accept 

electronic data using specifications 

prescribed by ONC for the public health 

objectives. We also published, pursuant 

to the Paperwork Reduction Act of 1995, 

a notice in the Federal Register on 

February 7, 2014 soliciting public 

comment on the proposed information 

collection required to develop the 

centralized repository on public health 

readiness (79 FR 7461). We considered 

the comments and we now propose 

moving forward with the development 

of the centralized repository. The 

centralized repository is integral to 

meaningful use and is expected to be 

available by the start of CY 2017. We 

expect that the centralized repository 

will include readiness updates for PHAs 

and CDRs at the state, local, and 

national level. We welcome your 

comments on the use and structure of 

the centralized repository. 

Proposed Measures: We are proposing 

a total of six possible measures for this 

objective. EPs would be required to 

choose from measures 1 through 5, and 

would be required to successfully attest 

to any combination of three measures. 

Eligible hospitals and CAHs would be 

required to choose from measures one 

through six, and would be required to 

successfully attest to any combination of 

four measures. The measures are as 

shown in Table 5. As noted, measures 

four and five for Public Health Registry 

Reporting and Clinical Data Registry 

Reporting may be counted more than 

once if more than one Public Health 

Registry or Clinical Data Registry is 

available. 

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TABLE 5—MEASURES FOR OBJECTIVE 8: PUBLIC HEALTH AND CLINICAL DATA REGISTRY REPORTING OBJECTIVE

Measure 

Maximum 

times measure 

can count towards objective for EP 

Maximum 

times measure 

can count towards objective for eligible 

hospital or 

CAH 

Measure 1—Immunization Registry Reporting ........................................................................................................ 1 1 

Measure 2—Syndromic Surveillance Reporting ...................................................................................................... 1 1 

Measure 3—Case Reporting ................................................................................................................................... 1 1 

Measure 4—Public Health Registry Reporting* ...................................................................................................... 3 4 

Measure 5—Clinical Data Registry Reporting** ...................................................................................................... 3 4 

Measure 6—Electronic Reportable Laboratory Results .......................................................................................... N/A 1 

* EPs, eligible hospitals, and CAHs may choose to report to more than one public health registry to meet the number of measures required to 

meet the objective. 

** EPs, eligible hospitals, and CAHs may choose to report to more than one clinical data registry to meet the number of measures required to 

meet the objective. 

For EPs, we propose that an exclusion 

for a measure does not count toward the 

total of three measures. Instead, in order 

to meet this objective, an EP would need 

to meet three of the total number of 

measures available to them. If the EP 

qualifies for multiple exclusions and the 

remaining number of measures available 

to the EP is less than three, the EP can 

meet the objective by meeting all of the 

remaining measures available to them 

and claiming the applicable exclusions. 

Available measures include ones for 

which the EP does not qualify for an 

exclusion. 

For eligible hospitals and CAHs, we 

propose that an exclusion for a measure 

does not count toward the total of four 

measures. Instead, in order to meet this 

objective an eligible hospital or CAH 

would need to meet four of the total 

number of measures available to them. 

If the eligible hospital or CAH qualifies 

for multiple exclusions and the total 

number of remaining measures available 

to the eligible hospital or CAH is less 

than four, the eligible hospital or CAH 

can meet the objective by meeting all of 

the remaining measures available to 

them and claiming the applicable 

exclusions. Available measures include 

ones for which the eligible hospital or 

CAH does not qualify for an exclusion. 

We note that we are proposing to 

allow EPs, eligible hospitals, and CAHs 

to choose to report to more than one 

public health registry to meet the 

number of measures required to meet 

the objective. We are also proposing to 

allow EPs, eligible hospitals, and CAHs 

to choose to report to more than one 

clinical data registry to meet the number 

of measures required to meet the 

objective. We believe that this flexibility 

allows for EPs, eligible hospitals, and 

CAHs to choose reporting options that 

align with their practice and that will 

aid the provider’s ability to care for their 

patients. 

Measure 1—Immunization Registry 

Reporting: The EP, eligible hospital, or 

CAH is in active engagement with a 

public health agency to submit 

immunization data and receive 

immunization forecasts and histories 

from the public health immunization 

registry/immunization information 

system (IIS). 

We believe the immunization registry 

reporting measure remains a priority for 

Stage 3 because the exchange of 

information between certified EHR 

technology and immunization registries 

allows a provider to use the most 

complete immunization history 

available to inform decisions about the 

vaccines a patient may need. Public 

health agencies and providers also use 

immunization information for 

emergency preparedness and to estimate 

population immunization coverage 

levels of certain vaccines. 

We propose that to successfully meet 

the requirements of this measure, 

bidirectional data exchange between the 

provider’s certified EHR technology and 

the immunization registry/IIS is 

required. We understand that many 

states and local public health 

jurisdictions are exchanging 

immunization data bidirectionally with 

providers, and that the number of states 

and localities able to support 

bidirectional exchange continues to 

increase. In the 2015 Edition proposed 

rule published by ONC elsewhere in 

this issue of the Federal Register, the 

ONC is proposing to adopt a 

bidirectional exchange standard for 

reporting to immunization registries/IIS. 

We believe this functionality is 

important for patient safety and 

improved care because it allows the 

provider to use the most complete 

immunization record possible to make 

decisions on whether a patient needs a 

vaccine. Immunization registries and 

health IT systems also are able to 

provide immunization forecasting 

functions which can inform discussions 

between providers and patients on what 

vaccines they may need in the future 

and the timeline for the receipt of such 

immunizations. Therefore, we believe 

that patients, providers, and the public 

health community would benefit from 

technology that can accommodate 

bidirectional immunization data 

exchange. We welcome comment on 

this proposal. 

Exclusion for Measure 1: Any EP, 

eligible hospital, or CAH meeting one or 

more of the following criteria may be 

excluded from the immunization 

registry reporting measure if the EP, 

eligible hospital, or CAH: (1) Does not 

administer any immunizations to any of 

the populations for which data is 

collected by their jurisdiction’s 

immunization registry or immunization 

information system during the EHR 

reporting period; (2) operates in a 

jurisdiction for which no immunization 

registry or immunization information 

system is capable of accepting the 

specific standards required to meet the 

CEHRT definition at the start of the EHR 

reporting period; or (3) operates in a 

jurisdiction where no immunization 

registry or immunization information 

system has declared readiness to receive 

immunization data at the start of the 

EHR reporting period. 

Measure 2—Syndromic Surveillance 

Reporting: The EP, eligible hospital, or 

CAH is in active engagement with a 

public health agency to submit 

syndromic surveillance data from a nonurgent care ambulatory setting for EPs, 

or an emergency or urgent care 

department for eligible hospitals and 

CAHs (POS 23). This measure remains 

a policy priority for Stage 3 because 

electronic syndromic surveillance is 

valuable for early detection of 

outbreaks, as well as monitoring disease 

and condition trends. We are 

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distinguishing between EPs and eligible 

hospital or CAHs reporting locations 

because, as discussed in the Stage 2 

final rule, few PHAs appeared to have 

the ability to accept non-emergency or 

non-urgent care ambulatory syndromic 

surveillance data electronically (77 FR 

53979). We continue to observe 

differences in the infrastructure and 

current environments for supporting 

electronic syndromic surveillance data 

submission to PHAs between eligible 

hospitals or CAHs and EPs. Because 

eligible hospitals and CAHs send 

syndromic surveillance data using 

different methods as compared to EPs, 

we are defining slightly different 

exclusions for each setting as described 

later in this section. 

Exclusion for EPs for Measure 2: Any 

EP meeting one or more of the following 

criteria may be excluded from the 

syndromic surveillance reporting 

measure if the EP: (1) Does not treat or 

diagnose or directly treat any disease or 

condition associated with a syndromic 

surveillance system in their jurisdiction; 

(2) operates in a jurisdiction for which 

no public health agency is capable of 

receiving electronic syndromic 

surveillance data from EPs in the 

specific standards required to meet the 

CEHRT definition at the start of the EHR 

reporting period; or (3) operates in a 

jurisdiction where no public health 

agency has declared readiness to receive 

syndromic surveillance data from EPs at 

the start of the EHR reporting period. 

Exclusion for eligible hospitals/CAHs 

for Measure 2: Any eligible hospital or 

CAH meeting one or more of the 

following criteria may be excluded from 

the syndromic surveillance reporting 

measure if the eligible hospital or CAH: 

(1) Does not have an emergency or 

urgent care department; (2) operates in 

a jurisdiction for which no public health 

agency is capable of receiving electronic 

syndromic surveillance data from 

eligible hospitals or CAHs in the 

specific standards required to meet the 

CEHRT definition at the start of the EHR 

reporting period; or (3) operates in a 

jurisdiction where no public health 

agency has declared readiness to receive 

syndromic surveillance data from 

eligible hospitals or CAHs at the start of 

the EHR reporting period. 

Measure 3—Case Reporting: The EP, 

eligible hospital, or CAH is in active 

engagement with a public health agency 

to submit case reporting of reportable 

conditions. 

This is a new reporting option that 

was not part of Stage 2. The collection 

of electronic case reporting data greatly 

improves reporting efficiencies between 

providers and the PHA. Public health 

agencies collect ‘‘reportable 

conditions’’, as defined by the state, 

territorial, and local PHAs to monitor 

disease trends and support the 

management of outbreaks. In many 

circumstances, there has been low 

reporting compliance because providers 

do not know when, where, or how to 

report. In some cases, the time burden 

to report can also contribute to low 

reporting compliance. However, 

electronic case reporting presents a core 

benefit to public health improvement 

and a variety of stakeholders have 

identified electronic case reporting as a 

high value element of patient and 

continuity of care. Further, we believe 

that electronic case reporting reduces 

burdensome paper-based and laborintensive case reporting. Electronic 

reporting will support more rapid 

exchange of case reporting information 

between PHAs and providers and can 

include structured questions or data 

fields to prompt the provider to supply 

additional required or care-relevant 

information. 

To support case reporting, the ONC 

has proposed a certification criterion 

that includes capabilities to enable 

certified EHR systems to send initial 

case reporting data and receive a request 

from the public health agency for 

supplemental or ad hoc structured data 

in the 2015 Edition proposed rule, 

published elsewhere in this issue of the 

Federal Register. 

Exclusion for Measure 3: Any EP, 

eligible hospital, or CAH meeting one or 

more of the following criteria may be 

excluded from the case reporting 

measure if the EP, eligible hospital, or 

CAH: (1) Does not treat or diagnose any 

reportable diseases for which data is 

collected by their jurisdiction’s 

reportable disease system during the 

EHR reporting period; (2) operates in a 

jurisdiction for which no public health 

agency is capable of receiving electronic 

case reporting data in the specific 

standards required to meet the CEHRT 

definition at the start of the EHR 

reporting period; or (3) operates in a 

jurisdiction where no public health 

agency has declared readiness to receive 

electronic case reporting data at the start 

of the EHR reporting period. 

Measure 4—Public Health Registry 

Reporting: The EP, eligible hospital, or 

CAH is in active engagement with a 

public health agency to submit data to 

public health registries. 

In the Stage 2 final rule, we were 

purposefully general in our use of the 

term ‘‘specialized registry’’ (other than a 

cancer registry) to encompass both 

registry reporting to public health 

agencies and clinical data registries in 

order to prevent inadvertent exclusion 

of certain registries through an attempt 

to be more specific (77 FR 54030). In 

response to insight gained from the 

industry through listening sessions, 

public forums, and reponses to the 

February 2014 Public Health Reporting 

RFI; we propose to carry forward the 

concept behind this broad category from 

Stage 2, but also propose to split public 

health registry reporting from clinical 

data registry reporting into two separate 

measures which better define the 

potential types of registries available for 

reporting. We propose to define a 

‘‘public health registry’’ as a registry 

that is administered by, or on behalf of, 

a local, state, territorial, or national PHA 

and which collects data for public 

health purposes. While immunization 

registries are a type of public health 

registry, we propose to keep 

immunization registry reporting 

separate from the public health registry 

reporting measure to retain continuity 

from Stage 1 and 2 policy in which 

immunization registry reporting was a 

distinct and separate objective (77 FR 

54023). We believe it is important to 

retain the public health registry 

reporting option for Stage 3 because 

these registries allow the public health 

community to monitor health and 

disease trends, and inform the 

development of programs and policy for 

population and community health 

improvement. 

We reiterate that any EP, eligible 

hospital, or CAH may report to more 

than one public health registry to meet 

the total number of required measures 

for the objective. For example, if a 

provider meets this measure through 

reporting to both the National Hospital 

Care Survey and the National 

Healthcare Safety Network registry, the 

provider could get credit for meeting 

two measures. ONC will consider the 

adoption of standards and 

implementation guides in future 

rulemaking. Should these subsequently 

be finalized, they may then be adopted 

as part of the certified EHR technology 

definition as it relates to meeting the 

public health registry reporting measure 

through future rulemaking for the EHR 

Incentive Programs. 

We further note that ONC adopted 

standards for ambulatory cancer case 

reporting in its final rule ‘‘2014 Edition, 

Release 2 EHR Certification Criteria and 

the ONC HIT Certification Program; 

Regulatory Flexibilities, Improvements, 

and Enhanced Health Information 

Exchange’’ (79 FR 54468) and we 

provided EPs the option to select the 

cancer case reporting menu objective in 

the Stage 2 final rule (77 FR 54029 

through 54030). We included cancer 

registry reporting as a separate objective 

from specialized registry reporting 

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12https://download.ama-assn.org/resources/doc/

cqi/x-pub/nqrn-what-is-clinical-data-registry.pdf. 

because it was more mature in its 

development than other registry types, 

not because other reporting was 

intended to be excluded from 

meaningful use. For the Stage 3 public 

health registry reporting measure, given 

the desire to provide more flexible 

options for providers to report to the 

registries most applicable for their scope 

of practice, we propose that EPs would 

have the option of counting cancer case 

reporting under the public health 

registry reporting measure. We note that 

cancer case reporting is not an option 

for eligible hospitals and CAHs under 

this measure because hospitals have 

traditionally diagnosed or treated 

cancers and have the infrastructure 

needed to report cancer cases. 

Exclusions for Measure 4: Any EP, 

eligible hospital, or CAH meeting at 

least one of the following criteria may 

be excluded from the public health 

registry reporting measure if the EP, 

eligible hospital, or CAH: (1) Does not 

diagnose or directly treat any disease or 

condition associated with a public 

health registry in their jurisdiction 

during the EHR reporting period; (2) 

operates in a jurisdiction for which no 

public health agency is capable of 

accepting electronic registry 

transactions in the specific standards 

required to meet the CEHRT definition 

at the start of the EHR reporting period; 

or (3) operates in a jurisdiction where 

no public health registry for which the 

EP, eligible hospital, or CAH is eligible 

has declared readiness to receive 

electronic registry transactions at the 

beginning of the EHR reporting period. 

Measure 5—Clinical Data Registry 

Reporting: The EP, eligible hospital, or 

CAH is in active engagement to submit 

data to a clinical data registry. 

As discussed in the Public Health 

Registry Reporting measure, we propose 

to split specialized registry reporting 

into two separate, clearly defined 

measures: Public health registry 

reporting and clinical data registry 

reporting. In Stage 2 for EPs, reporting 

to specialized registries is a menu 

objective and this menu objective 

includes reporting to clinical data 

registries. For Stage 3, we propose to 

include clinical data registry reporting 

as an independent measure. The 

National Quality Registry Network 

defines clinical data registries as those 

that record information about the health 

status of patients and the health care 

they receive over varying periods of 

time.12 We propose to further 

differentiate between clinical data 

registries and public health registries as 

follows: For the purposes of meaningful 

use, ‘‘public health registries’’ are those 

administered by, or on behalf of, a local, 

state, territorial, or national public 

health agencies; and ‘‘clinical data 

registries’’ are administered by, or on 

behalf of, other non-public health 

agency entities. We believe that clinical 

data registries are important for 

providing information that can inform 

patients and their providers on the best 

course of treatment and for care 

improvements, and can support 

specialty reporting by developing 

reporting for areas not usually covered 

by PHAs but that are important to a 

specialist’s provision of care. Clinical 

data registries can also be used to 

monitor health care quality and resource 

use. 

As noted previously, we reiterate that 

any EP, eligible hospital, or CAH may 

report to more than one clinical data 

registry to meet the total number of 

required measures for this objective. 

ONC will consider the adoption of 

standards and implementation guides in 

future rulemaking. Should these 

subsequently be finalized, they may 

then be adopted as part of the certified 

EHR technology definition as it relates 

to meeting the clinical data registry 

reporting measure through future 

rulemaking for the EHR Incentive 

Programs. 

Exclusions for Measure 5: Any EP, 

eligible hospital, or CAH meeting at 

least one of the following criteria may 

be excluded from the clinical data 

registry reporting measure if the EP, 

eligible hospital, or CAH: (1) Does not 

diagnose or directly treat any disease or 

condition associated with a clinical data 

registry in their jurisdiction during the 

EHR reporting period; (2) operates in a 

jurisdiction for which no clinical data 

registry is capable of accepting 

electronic registry transactions in the 

specific standards required to meet the 

CEHRT definition at the start of the EHR 

reporting period; or (3) operates in a 

jurisdiction where no clinical data 

registry for which the EP, eligible 

hospital, or CAH is eligible has declared 

readiness to receive electronic registry 

transactions at the beginning of the EHR 

reporting period. 

Measure 6—Electronic Reportable 

Laboratory Result Reporting: The 

eligible hospital or CAH is in active 

engagement with a public health agency 

to submit electronic reportable 

laboratory results. This measure is 

available to eligible hospitals and CAHs 

only. Electronic reportable laboratory 

result reporting to PHAs is required for 

eligible hospitals and CAHs in Stage 2 

(77 FR 54021). We propose to retain this 

measure for Stage 3 to promote the 

exchange of laboratory results between 

eligible hospitals/CAHs and PHAs for 

improved timeliness, reduction of 

manual data entry errors, and more 

complete information. 

Exclusion for Measure 6: Any eligible 

hospital or CAH meeting one or more of 

the following criteria may be excluded 

from the electronic reportable laboratory 

result reporting measure if the eligible 

hospital or CAH: (1) Does not perform 

or order laboratory tests that are 

reportable in their jurisdiction during 

the EHR reporting period; (2) operates in 

a jurisdiction for which no public health 

agency is capable of accepting the 

specific ELR standards required to meet 

the CEHRT definition at the start of the 

EHR reporting period; or (3) operates in 

a jurisdiction where no public health 

agency has declared readiness to receive 

electronic reportable laboratory results 

from an eligible hospital or CAH at the 

start of the EHR reporting period. 

The Use of CEHRT for the Public 

Health and Clinical Data Registry 

Reporting Objective 

As proposed previously, the Public 

Health and Clinical Data Registry 

Reporting objective requires active 

engagement with a public health agency 

to submit electronic public health data 

from certified EHR technology. ONC 

defined the standards and certification 

criteria to meet the definition of CEHRT 

in its 2011, 2014, and 2014 Release 2 

Edition EHR certification criteria rules 

(see section II.B. of the ‘‘2014 Edition, 

Release 2 EHR Certification Criteria and 

the ONC HIT Certification Program; 

Regulatory Flexibilities, Improvements, 

and Enhanced Health Information 

Exchange’’ for a full description of 

ONC’s regulatory history; (79 FR 

54434)). For example, ONC adopted 

standards for immunization reporting 

(see § 170.314(f)(1) and (f)(2)), inpatient 

syndromic surveillance (see 

§ 170.314(f)(3) and (f)(7)), ELR (see 

§ 170.314(f)(4)), and cancer case 

reporting (see § 170.314(f)(5) and (f)(6)) 

in its 2014 Edition final rule. 

We support ONC’s intent to promote 

standardized and interoperable 

exchange of public health data across 

the country. Therefore, to meet all of the 

measures within this public health 

objective EPs, eligible hospitals, and 

CAHs must use CEHRT as we propose 

to define it under § 495.4 in this 

proposed rule and use the standards 

included in the 2015 Edition proposed 

rule published elsewhere in this edition 

of the Federal Register. We anticipate 

that as new public health registries and 

clinical data registries are created, ONC 

and CMS will work with the public 

health community and clinical specialty 

societies to develop ONC-certified 

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electronic reporting standards for those 

registries so that providers have the 

option to count participation in those 

registries under the measures of this 

objective. ONC will look to adopt such 

standards, as appropriate, in future rules 

published by ONC. 

We welcome public comment on 

these proposals. 

II. Provisions of the Proposed 

Regulations 

A. Meaningful Use Requirements, 

Objectives and Measures 

2. Certified EHR Technology (CEHRT) 

Requirements 

Certified EHR technology is defined 

for the Medicare and Medicaid EHR 

Incentive Programs at 42 CFR 495.4, 

which references ONC’s definition of 

CEHRT under 45 CFR 170.102. The 

definition establishes the requirements 

for EHR technology that must be used 

by providers to meet the meaningful use 

objectives and measures. The Stage 2 

final rule requires that CEHRT must be 

used by EPs, eligible hospitals, and 

CAHs to satisfy their CQM reporting 

requirements under the Medicare and 

Medicaid EHR Incentive Programs. In 

addition, the CQM data reported to CMS 

must originate from EHR technology 

that is certified to ‘‘capture and export’’ 

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

and ‘‘electronic submission’’ in 

accordance with 45 CFR 170.314(c)(3) 

(77 FR 54053). 

On September 4, 2014, CMS and ONC 

published a final rule in the Federal 

Register (79 FR 52910 through 52933) 

that, among other things, modified the 

meaningful use requirements for 2014 

and the CEHRT definition. 

First, we granted flexibility to 

providers who experienced product 

availability issues that affected their 

ability to fully implement EHR 

technology certified to the 2014 Edition 

of certification criteria (79 FR 52913 

through 52926). We allowed those EPs, 

eligible hospitals, and CAHs to continue 

using either EHR technology certified to 

the 2011 Edition, or a combination of 

EHR technology certified to the 2011 

Edition and 2014 Edition, for the EHR 

reporting periods in CY 2014 and FY 

2014. EPs, eligible hospitals, and CAHs 

could take one of these approaches if 

they were unable to fully implement 

EHR technology certified to the 2014 

Edition for an EHR reporting period in 

2014 due to delays in the availability of 

EHR technology certified to the 2014 

Edition. 

Second, we established that in order 

to receive an incentive payment for 

2014 under Medicaid for adopting, 

implementing, or upgrading CEHRT, a 

provider must adopt, implement, or 

upgrade to EHR technology certified to 

the 2014 Edition and meet the CEHRT 

definition (79 FR 52925 through 52926). 

Finally, ONC revised the CEHRT 

definition under 45 CFR 170.102 to 

align with our policy allowing for the 

use of EHR technology certified to the 

2011 Edition, or a combination of EHR 

technology certified to the 2011 Edition 

and 2014 Edition, in 2014 (79 FR 

52930). 

For further detail on the changes to 

the requirements for 2014 and CEHRT 

definition, we refer readers to the 2014 

CEHRT Flexibility final rule (79 FR 

52910 through 52933). 

a. CEHRT Definition for the EHR 

Incentive Programs 

As we have stated previously in 

rulemaking, the statute and regulations 

require EPs, eligible hospitals, and 

CAHs to use ‘‘Certified EHR 

Technology’’ if they are to be considered 

meaningful EHR users and eligible for 

incentive payments under Medicare or 

Medicaid, and to avoid payment 

adjustments under Medicare (for 

example, see section 1848(o)(2)(A)(i) of 

the Act, and 42 CFR 495.4). However, in 

contrast to prior rulemaking cycles 

where ONC has established a 

meaningful-use-specific CEHRT 

definition for the EHR Incentive 

Programs that CMS has adopted by 

cross-reference under 42 CFR 495.4, we 

propose to take a different approach 

under which we would define the term 

‘‘Certified EHR Technology,’’ and that 

definition would be specific to the EHR 

Incentive Programs. 

This proposed change is designed to 

simplify the overall regulatory 

relationship between ONC and CMS 

rules for stakeholders and to ensure that 

relevant CMS policy for the EHR 

Incentive Programs is clearly referenced 

in CMS regulations. For example, ONC’s 

definition of CEHRT under 45 CFR 

170.102 includes the compliance dates 

for EPs, eligible hospitals, and CAHs to 

use EHR technology certified to a 

particular edition of certification criteria 

to meet the CEHRT definition and for 

purposes of the EHR Incentive 

Programs, such as the requirement to 

use EHR technology certified to the 

2014 Edition beginning in 2015. Under 

the proposed new approach, we would 

establish through rulemaking for the 

EHR Incentive Programs (either with 

stand-alone rulemaking or through other 

vehicles such as the annual Medicare 

payment rules) the compliance dates by 

which providers must use EHR 

technology certified to a particular 

edition of certification criteria to meet 

the CEHRT definition, which would be 

reflected in our regulations under 42 

CFR part 495 rather than ONC’s 

regulations under 45 CFR part 170. 

b. Defining CEHRT for 2015 Through 

2017 and for 2018 and Subsequent 

Years 

In adopting a CEHRT definition 

specific for the EHR Incentive Programs, 

we propose to include, as currently for 

the ONC CEHRT definition under 45 

CFR 170.102, the relevant Base EHR 

definitions adopted by ONC in 45 CFR 

170.102 and other ONC certification 

criteria relevant to the EHR Incentive 

Programs. We refer readers to ONC’s 

2015 Edition proposed rule published 

elsewhere in this issue of the Federal 

Register for the proposed 2015 Edition 

Base EHR definition and discussion of 

the 2014 Edition Base EHR definition. 

We are including the Base EHR 

definition(s) because as ONC explained 

in the 2014 Edition final rule ‘‘2014 

Edition, Release 2 EHR Certification 

Criteria and the ONC HIT Certification 

Program; Regulatory Flexibilities, 

Improvements, and Enhanced Health 

Information Exchange’’ (77 FR 54443 

through 54444) the ‘‘Base EHR’’ 

essentially serves as a substitute for the 

term ‘‘Qualified EHR’’ in the definition 

of CEHRT. The term ‘‘Qualified EHR’’ is 

defined in section 3000(13) of the 

PHSA, to include certain capabilities 

listed in that section, and is included in 

the statutory definition of ‘‘certified 

EHR technology’’ for the EHR Incentive 

Programs (for example, see section 

1848(o)(4) of the Act). The Base EHR 

definition(s) also include additional 

capabilities as proposed by ONC that we 

agree all providers should have that are 

participating in the EHR Incentive 

Programs to support their attempts to 

meet meaningful use objectives and 

measures as well as interoperable health 

information exchange. 

We propose to define the editions of 

certification criteria that may be used 

for years 2015 through 2017 to meet the 

CEHRT definition. At a minimum, EPs, 

eligible hospitals, and CAHs would be 

required to use EHR technology certified 

to the 2014 Edition certification criteria 

for their respective EHR reporting 

periods in 2015 through 2017. A 

provider may also upgrade to the 2015 

Edition prior to 2018 to meet the 

required certified EHR technology 

definition for the EHR reporting periods 

in 2015, 2016, or 2017, or they may use 

a combination of 2014 and 2015 

Editions prior to 2018 if they have 

modules from both Editions which meet 

the requirements for the objectives and 

measures or if they fully upgrade during 

an EHR reporting period. 

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Based on experience with delays in 

the availability of EHR technology 

certified to the 2014 Edition for 

providers to implement and use to meet 

meaningful use for an EHR reporting 

period in 2014, we propose to include 

as part of the CEHRT definition a longer 

period of time for providers to use 

technology certified to the 2014 Edition 

in an effort to give providers more time 

in updating their technology to the 2015 

Edition before the EHR reporting period 

in 2018. We also propose to make the 

use of a combination of technology 

certified to the 2014 Edition and 2015 

Edition to meet the CEHRT definition 

more flexible in 2015 through 2017 by 

taking into account ONC’s proposed 

new privacy and security certification 

approach for health IT (see ONC’s 2015 

Edition proposed rule published 

elsewhere in this issue of the Federal 

Register). Specifically, as a provider 

updates to technology certified to the 

2015 Edition, the provider would not 

necessarily need to continue to meet the 

privacy and security capability 

requirements of the 2014 Edition Base 

EHR definition because the technology 

they adopt certified to the 2015 Edition 

would include necessary privacy and 

security capabilities. Additionally, 

because ONC is proposing, for the 2015 

Edition, to no longer require 

certification of Health IT Modules to 

capabilities that support meaningful use 

objectives with percentage-based 

measures, we propose to include these 

capabilities (45 CFR 170.314(g)(1) or (2) 

or 45 CFR 170.315(g)(1) or (2)), as 

applicable, in the CEHRT definition for 

2015 through 2017 so that providers 

have technology that can appropriately 

record and calculate meaningful use 

measures. We note that there are many 

combinations of 2014 and 2015 Edition 

certified technologies that could be used 

to successfully meet the transitions of 

care requirements included in the 2014 

and 2015 Edition Base EHR definitions 

for the purposes of meeting meaningful 

use objectives and measures. We believe 

we have identified all combinations in 

the proposed regulation text under 

§ 495.4 that could be used to meet the 

CEHRT definition through 2017 and be 

used for the purposes of meeting 

meaningful use objectives and 

measures. We welcome comments on 

the accuracy of the identified available 

options. 

We propose that starting with 2018, 

all EPs, eligible hospitals, and CAHs 

would be required to use technology 

certified to the 2015 Edition to meet the 

CEHRT definition and demonstrate 

meaningful use for an EHR reporting 

period in 2018 and subsequent years. 

The CEHRT definition would include, 

for the reasons discussed previously, 

meeting the 2015 Edition Base EHR 

definition and having other important 

capabilities, that include the capabilities 

to— 

• Record or create and incorporate 

family health history; 

• Capture patient health information 

such as advance directives; 

• Record numerators and 

denominators for meaningful use 

objectives with percentage-based 

measures and calculate the percentages; 

• Calculate and report clinical quality 

measures; and 

• Any other capabilities needed to be 

a Meaningful EHR User. 

For information on 2015 Edition 

certification criteria that include these 

capabilities and are associated with 

proposed Meaningful Use objectives for 

Stage 3, please see the 2015 Edition 

proposed rule published elsewhere in 

this issue of the Federal Register. We 

expect that the certification criteria with 

capabilities that support CQM 

calculation and reporting would be 

jointly proposed with CQM reporting 

requirements in a separate rulemaking. 

c. Proposed Definition for CEHRT 

For the reasons stated previously, we 

propose to adopt a definition of 

Certified EHR Technology under 42 CFR 

495.4 for the Medicare and Medicaid 

EHR Incentive Programs that would 

apply for the EHR reporting periods in 

2015 up to and including 2017 and for 

the EHR reporting periods in 2018 and 

subsequent years. We refer readers to 

ONC’s 2015 Edition proposed rule 

published elsewhere in this issue of the 

Federal Register for further explanation 

of the concepts and terms used in our 

proposed definition of Certified EHR 

Technology, including the 2014 Edition 

Base EHR definition, 2015 Edition Base 

EHR definition, certification criteria, 

and the regulation text under 45 CFR 

part 170. 

B. Reporting on Clinical Quality 

Measures Using Certified EHR 

Technology by EPs, Eligible Hospitals, 

and Critical Access Hospitals 

1. Clinical Quality Measure (CQM) 

Requirements for Meaningful Use in 

2017 and Subsequent Years 

Under sections 1848(o)(2)(A), 

1886(n)(3)(A), and 1814(l)(3)(A) of the 

Act and 42 CFR 495.4, EPs, eligible 

hospitals, and CAHs must report on 

CQMs selected by CMS using certified 

EHR technology, as part of being a 

meaningful EHR user under the 

Medicare and Medicaid EHR Incentive 

Programs. 

In regard to the selection of CQMs, we 

expect to continue to include CQMs that 

align with the National Quality Strategy; 

as well as, the our Quality Strategy. We 

also expect to consider programmatic 

goals and outcome measures that would 

advance patient and population health. 

a. Clinical Quality Measure Reporting 

Requirements for EPs 

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

requires that in selecting measures for 

EPs for the Medicare EHR Incentive 

Program, and in establishing the form 

and manner of reporting, the Secretary 

shall seek to avoid redundant or 

duplicative reporting, including 

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

the Physician Quality Reporting System 

(PQRS). Consistent with that 

requirement, in the Stage 2 final rule, 

we finalized a policy to align certain 

aspects of reporting CQMs for the 

Medicare EHR Incentive Program for 

EPs with reporting under the PQRS. 

Specifically, we stated that Medicare 

EPs who participate in both the PQRS 

and the Medicare EHR Incentive 

Program will satisfy the CQM reporting 

component of meaningful use if they 

submit and satisfactorily report PQRS 

CQMs under the PQRS’s EHR reporting 

option using CEHRT (77 FR 54058). 

Section 1848(m)(7) of the Act requires 

the Secretary to develop a plan to 

integrate reporting on quality measures 

under the PQRS with reporting 

requirements under the Medicare EHR 

Incentive Program relating to the 

meaningful use of electronic health 

records. Therefore, it is our goal to align 

the reporting requirements for the CQM 

component of meaningful use under the 

Medicare EHR Incentive Program and 

for PQRS wherever possible. 

Historically, most requirements for the 

Medicare and Medicaid EHR Incentive 

Programs have been established through 

stand-alone rulemaking, such as the 

rules for Stage 1 (75 FR 44314 through 

44588) and Stage 2 (77 FR 53968 

through 54162), which span multiple 

program years. This limited our ability 

to align the EHR Incentive Program with 

the requirements established in the 

annual Medicare payment rules for 

other CMS quality programs affecting 

physicians and other EPs. 

To further our goals of alignment and 

avoiding redundant or duplicative 

reporting across the various CMS 

quality reporting programs, we intend to 

address CQM reporting requirements for 

the Medicare and Medicaid EHR 

Incentive Program for EPs for 2017 and 

subsequent years in the Medicare 

Physician Fee Schedule (PFS) 

rulemaking, which also establishes the 

requirements for PQRS and other 

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quality programs affecting EPs. We note 

that the form and manner of reporting 

of CQMs for Medicare EPs would also 

be included in the PFS, while for 

Medicaid we would continue to allow 

the states to determine form and method 

requirements subject to CMS approval. 

We propose to continue the policy of 

establishing certain CQM requirements 

that apply for both the Medicare and 

Medicaid EHR Incentive Programs 

including a common set of CQMs and 

the reporting periods for CQMs in the 

EHR Incentive Programs. However, we 

believe that receiving and reviewing 

public comments for various CMS 

quality programs at one time (for 

example, EHR Incentive Program, PQRS, 

Physician Compare); and finalizing the 

requirements for these programs 

simultaneously, would allow us to 

better align these programs for EPs to 

support streamlined reporting and 

program efficacy. We propose to 

continue to support active 

communication with providers to 

facilitate the sharing of information 

related to CQM selection and reporting, 

the announcement of opportunities for 

public comment on CQM selection and 

reporting, and upcoming or relevant 

CQM program milestones in partnership 

with state Medicaid programs and the 

Medicare quality reporting programs. 

We propose to continue to post the 

defined CQM sets and the published 

electronic specifications for CQM that 

are in use for all aligned programs on 

the CMS Web site as currently posted on 

the eCQM Library page: http://

www.cms.gov/Regulations-andGuidance/Legislation/

EHRIncentivePrograms/eCQM_

Library.html. 

b. CQM Reporting Requirements for 

Eligible Hospitals and Critical Access 

Hospitals 

Section 1886(n)(3)(B)(iii) of the Act 

requires that, in selecting measures for 

eligible hospitals for the Medicare EHR 

Incentive Program, and establishing the 

form and manner for reporting 

measures, the Secretary shall seek to 

avoid redundant or duplicative 

reporting with reporting otherwise 

required, including reporting under 

section 1886(b)(3)(B)(viii) of the Act, the 

Hospital IQR Program. 

Similar to our intentions for EPs 

discussed previously, and to further our 

alignment goal among CMS quality 

reporting programs for eligible hospitals 

and CAHs, and avoid redundant or 

duplicative reporting among hospital 

programs, we intend to address CQM 

reporting requirements for the Medicare 

and Medicaid EHR Incentive Program 

for eligible hospitals and CAHs for 2016, 

2017, and future years, in the Inpatient 

Prospective Payment System (IPPS) 

rulemaking. IPPS rulemaking also 

establishes the requirements for the 

Hospital IQR Program and other quality 

programs affecting hospitals. We intend 

to include all Medicare EHR Incentive 

Program requirements related to CQM 

reporting in the IPPS rulemaking 

including, but not limited to, new 

program requirements, reporting 

requirements, reporting and submission 

periods, reporting methods, and 

information regarding the CQMs. As 

with EPs, for the Medicaid EHR 

Incentive Program we would continue 

to allow the states to determine form 

and method requirements subject to 

CMS approval. However, as previously 

noted, this proposal would continue the 

policy of establishing certain CQM 

requirements that apply for both the 

Medicare and Medicaid EHR Incentive 

Programs including a common set of 

CQMs and the reporting periods for 

CQMs in the EHR Incentive Programs. 

We believe that receiving and reviewing 

public comments for various CMS 

quality programs at one time and 

finalizing the requirements for these 

programs simultaneously would allow 

us to better align these programs for 

eligible hospitals and CAHs, allow more 

flexibility into the Medicare and 

Medicaid EHR Incentive Programs, and 

add overall value and consistency by 

providing us the opportunity to address 

public comments that affect multiple 

programs at one time. We propose to 

continue to support active 

communication with providers to 

facilitate the sharing of information 

related to CQM selection and reporting, 

the announcement of opportunities for 

public comment on CQM selection and 

reporting, and upcoming or relevant 

CQM program milestones in partnership 

with state Medicaid programs and the 

Medicare quality reporting programs. 

We propose to continue to post the 

defined CQM sets and the published 

electronic specifications for CQM that 

are in use for all aligned programs on 

the CMS Web site as currently posted on 

the eCQM Library page: http://

www.cms.gov/Regulations-andGuidance/Legislation/

EHRIncentivePrograms/eCQM_

Library.html. 

2. CQM Reporting Period 

In the Stage 2 final rule, we finalized 

a reporting period for CQMs for EPs, 

eligible hospitals, and CAHs (see 77 FR 

54049 through 54051). In the FY 2015 

IPPS final rule, we began to shift CQM 

reporting to a calendar year basis for 

eligible hospitals and CAHs for the 

Medicare EHR Incentive Program (79 FR 

50319 through 50321). We established 

that for eligible hospitals and CAHs that 

submit CQMs electronically in 2015, the 

reporting period is one calendar quarter 

from Q1, Q2, or Q3 of CY 2015 (79 FR 

50321). 

As discussed in sections 

II.A.1.c.(1).(b).(i). and II.F. of this 

proposed rule, we are proposing to 

require an EHR reporting period of 1 full 

calendar year for meaningful use for 

providers participating in the Medicare 

EHR Incentive Program, with a limited 

exception for Medicaid providers 

demonstrating meaningful use for the 

first time. We are proposing to require 

the same length for the CQM reporting 

period for EPs, eligible hospitals, and 

CAHs beginning in 2017. As noted, we 

are proposing a limited exception for 

Medicaid providers demonstrating 

meaningful use for the first time who 

would have a CQM reporting period of 

any continuous 90 days that is the same 

90-day period as their EHR Reporting 

Period. 

We believe full year reporting would 

allow for the collection of more 

comparable data across CMS quality 

programs and increase alignment across 

those programs. The more robust data 

set provided by a full year reporting 

period offers more opportunity for 

alignment than the data set provided by 

a shorter reporting period, especially 

compared across years. We further 

believe this full calendar year reporting 

period for CQMs would reduce the 

complexity of reporting requirements 

for the Medicare EHR Incentive Program 

by streamlining the reporting timeline 

for providers for CQMs and meaningful 

use objectives and measures. We 

welcome comment on the following 

proposals. 

a. CQM Reporting Period for EPs 

With the previously stated 

considerations in mind, and in an effort 

to align with other CMS quality 

reporting programs such as the PQRS, 

we propose to require for CQM 

reporting under the EHR Incentive 

Program a reporting period of one full 

calendar year for all EPs participating in 

the Medicare and Medicaid EHR 

Incentive Program, with a limited 

exception for Medicaid providers 

demonstrating meaningful use for the 

first time who would have a CQM 

reporting period of any continuous 90 

days that is the same 90-day period as 

their EHR Reporting Period. These 

reporting periods would apply 

beginning in CY 2017 for all EPs 

participating in the EHR Incentive 

Program. 

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b. CQM Reporting Period for Eligible 

Hospital/CAH 

For eligible hospitals and CAHs in 

2017 and subsequent years, we are 

proposing to require a reporting period 

of 1 full calendar year which consists of 

4 quarterly data reporting periods for 

providers participating in the Medicare 

and Medicaid EHR Incentive Program, 

with a limited exception for Medicaid 

providers demonstrating meaningful use 

for the first time who would have a 

CQM reporting period of any 

continuous 90 days that is the same 90- 

day period as their EHR Reporting 

Period. More details of the form and 

manner will be provided in the IPPS 

rulemaking cycle. 

c. Reporting Flexibility EPs, Eligible 

Hospitals, CAHs 2017 

In order to align with the flexibility 

option of participation in Meaningful 

Use in 2017 (see section II.C.1.b. of this 

proposed rule), we are proposing that 

EPs, eligible hospitals, and CAHs would 

be able to have more flexibility to report 

CQMs in one of two ways in 2017—via 

electronic reporting or attestation. First 

EPs, eligible hospitals, and CAHs may 

choose to report eCQMs electronically 

using the CQMs finalized for use in 

2017 using the most recent version of 

the eCQMs (electronic specifications), 

which would be the electronic 

specifications of the CQMs published by 

CMS in 2016. Alternately, a provider 

may choose to continue to attest also 

using the most recent (2016 version) 

eCQM electronic specifications. We note 

that the intent to allow attestation in 

2017 is to provide flexibility for 

providers transitioning between 

versions of CEHRT in 2017 and believe 

that requiring the most recent version of 

the annual updates should not be a 

significant burden given that developers 

do not need to recertify a product each 

time CQM specifications are updated. 

However, we seek comment on if CMS 

should consider allowing providers to 

report using another earlier version of 

the specifications. 

We note that, unlike the flexible 

options established in rulemaking in 

2014 (79 FR 52927 through 52930), 

providers may select the CQMs they 

choose to report separately from the 

Stage objectives and measures of 

meaningful use for their EHR reporting 

period in 2017. 

We invite public comment on our 

proposals. 

3. Reporting Methods for CQMs 

In the Stage 2 final rule, we finalized 

the reporting methods for CQMs for EPs 

(77 FR 54075 through 54078), eligible 

hospitals, and CAHs (77 FR 54087 

through 54089) for the Medicare EHR 

Incentive Program, which included 

reporting electronically, where feasible, 

or by attestation. To further align the 

Medicare and Medicaid EHR Incentive 

Programs with programs such as PQRS 

and the Hospital IQR program, starting 

in 2017, we propose to continue to 

encourage electronic submission of 

CQM data for all EPs, eligible hospitals, 

and CAHs where feasible; however, as 

outlined in section II.C.1.b. of this 

proposed rule, we would allow 

attestation for CQMs in 2017. For 2018 

and subsequent years, we are proposing 

that providers participating in the 

Medicare program must electronically 

report where feasible and that 

attestation to CQMs would no longer be 

an option except in certain 

circumstances where electronic 

reporting is not feasible. This would 

include providers facing circumstances 

which render them unable to 

electronically report (such as a data 

submission system failure, natural 

disaster, or certification issue outside 

the control of the provider) who may 

attest to CQMs if they also attest that 

electronically reporting was not feasible 

for their demonstration of meaningful 

use for a given year. We believe that the 

collection and electronic reporting of 

data through health information 

technology would greatly simplify and 

streamline reporting for many CMS 

quality reporting programs and reduce 

the burden of quality measure reporting 

for providers who participate in these 

programs. We also believe this would 

further encourage the adoption and use 

of certified EHR technology by allowing 

EPs, eligible hospitals, and CAHs to 

report data for multiple programs 

through a single electronic submission. 

Through electronic reporting, EPs, 

eligible hospitals, and CAHs would be 

able to leverage EHRs to capture, 

calculate, and electronically submit 

quality data to CMS for the Medicare 

EHR Incentive Program. We note that 

we intend to address the form and 

manner of electronic reporting in future 

Medicare payment rules. 

For the Medicaid EHR Incentive 

Program, as in the Stage 2 rulemaking 

(77 FR 54089), we propose that states 

would continue in Stage 3 to be 

responsible for determining whether 

and how electronic reporting of CQMs 

would occur, or whether they wish to 

continue to allow reporting through 

attestation. If a state does require such 

electronic reporting, the state is 

responsible for sharing the details of the 

process with its provider community. 

We anticipate that whatever means 

states have deployed for capturing 

CQMs electronically for Stages 1 and 2 

would be similar for reporting in Stage 

3. However, we note that subject to our 

prior approval, this is within the states’ 

purview. We propose for Stage 3 that 

the states would establish the method 

and requirements, subject to our prior 

approval, for the electronic capture and 

reporting of CQMs from CEHRT. 

PROPOSED eCQM REPORTING TIMELINES FOR MEDICARE & MEDICAID EHR INCENTIVE PROGRAM

Year ................................... 2017 only .......................... 2017 only .......................... 2018 and subsequent 

years.

2018 and subsequent 

years. 

Reporting Method Available.Attestation ......................... Electronic Reporting .......... Attestation ......................... Electronic Reporting. 

Provider Type who May 

Use Method.

All Medicare providers ...... All Medicare Providers ...... Medicare Providers with 

circumstances rendering 

them unable to eReport.

All Medicare Providers. 

Medicaid providers must 

refer to state requirements for reporting.

Medicaid providers must 

refer to state requirements for reporting.

Medicaid providers must 

refer to state requirements for reporting.

Medicaid providers must 

refer to state requirements for reporting. 

CQM Reporting Period ...... 1 CY for Medicare ............. 1 CY for Medicare ............. 1 CY for Medicare ............. 1 CY for Medicare. 

1 CY for returning Medicaid.1 CY for returning Medicaid.1 CY for returning Medicaid.1 CY for returning Medicaid. 

90 days for first time 

meaningful user Medicaid.

90 days for first time 

meaningful user Medicaid.

90 days for first time 

meaningful user Medicaid.

90 days for first time 

meaningful user Medicaid. 

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PROPOSED eCQM REPORTING TIMELINES FOR MEDICARE & MEDICAID EHR INCENTIVE PROGRAM—Continued 

eCQM Version Required 

(CQM electronic specifications update).

2016 Annual Update ......... 2016 Annual Update ......... 2016 Annual Update or 

more recent version.

2017 Annual Update. 

CEHRT Edition Required .. 2014 Edition ......................

Or 

2015 Edition 

2014 Edition ......................

Or 

2015 Edition 

2015 Edition ...................... 2015 Edition. 

We invite public comments on our 

proposals. 

a. Quality Reporting Data Architecture 

Category III (QRDA–III) Option for 

Eligible Hospitals and CAHs 

In the Stage 2 final rule (77 FR 54088), 

we finalized two options for eligible 

hospitals and CAHs to electronically 

submit CQMs beginning in FY 2014 

under the Medicare EHR Incentive 

Program. Option 1 was to submit 

aggregate level CQM data using QRDA– 

III electronically. Option 2 was to 

submit data electronically using a 

method similar to the 2012 and 2013 

Medicare EHR Incentive Program 

electronic reporting pilot for eligible 

hospitals and CAHs, which used 

QRDA–I (patient-level data). 

We noted in the FY 2014 and 2015 

IPPS/LTCH PPS final rules (78 FR 50904 

through 50905 and 79 FR 50321 through 

50322) that we had determined that the 

electronic submission of aggregate-level 

data using QRDA–III would not be 

feasible in 2014 or 2015 for eligible 

hospitals and CAHs under the Medicare 

EHR Incentive Program. We stated that 

we would reassess this policy for future 

reporting periods. 

In this proposed rule, we are 

proposing to remove the QRDA–III 

option for eligible hospitals and CAHs, 

as we have found this is not an option 

for electronic reporting as we move 

forward with the EHR Incentive 

Program, we believe the calculations, 

per the QRDA–III, are not advantageous 

to quality improvement. As the EHR 

Incentive Program further aligns with 

the Hospital IQR program, we intend to 

continue utilizing the electronic 

reporting standard of QRDA–I patient 

level data that we finalized in the FY 

2015 IPPS rule (79 FR 50322), which 

will allow the same level of CQM 

reporting, and use and analysis of these 

data for quality improvement initiatives. 

As we understand the need to support 

state flexibility, we are also proposing 

that states would continue to have the 

option, subject to our prior approval, to 

allow or require QRDA–III for CQM 

reporting. 

4. CQM Specification and Changes to 

the Annual Update 

In the Stage 2 final rule, we stated that 

we do not intend to use notice and 

comment rulemaking as a means to 

update or modify electronic CQM 

(eCQM) specifications (77 FR 54055). In 

general, it is the role of the measure 

steward to make changes to a CQM in 

terms of the initial patient population, 

numerator, denominator, potential 

exclusions, logic, and value sets. We 

recognize that it may be necessary to 

update CQM specifications after they 

have been published to ensure their 

continued clinical relevance, accuracy, 

and validity. CQM specification updates 

may include administrative changes, 

such as adding the NQF endorsement 

number to a CQM, correcting faulty 

logic, adding or deleting codes as well 

as providing additional implementation 

guidance for a CQM. 

These changes are described through 

the annual updates to the electronic 

specifications for EHR submission 

published by CMS. CQMs are currently 

tracked on a version basis as updates are 

made and we require EPs, eligible 

hospitals, and CAHs to submit the 

versions of the CQMs as identified on 

our Web site. The Web site contains all 

versions of the CQMs since reporting via 

attestation does not require the most 

recent version of the CQMs, but 

electronic reporting of the CQMs does 

require the most recent version to be 

reported. Because we require the most 

recent version of the CQM specifications 

to be used for electronic reporting 

methods, we understand that EHR 

vendors must make CQM updates on an 

annual basis. We also understand that 

providers must regularly implement 

those updates to stay current with the 

most recent CQM version. 

We continue to evaluate the CQM 

update timeline and look for ways to 

provide CQM updates timely, so that 

vendors can develop, test, and deploy 

these updates and providers can 

implement those updates as necessary. 

We have the flexibility to update CQMs 

so they remain clinically relevant, 

accurate, and valid. While we are not 

proposing any change to our policy on 

updating CQM specifications in this 

proposed rule, we seek comment on our 

annual update timeline and suggestions 

for how to improve the CQM update 

process. 

5. EHR Technology Certification 

Requirements for Reporting of CQMs 

In the 2014 Edition EHR Certification 

Criteria Final Rule, ONC finalized 

certain certification criteria to support 

the MU objectives and CQMs set forth 

by CMS. In that rule, ONC also specified 

that in order for an EP, eligible hospital, 

or CAH to have EHR technology that 

meets the Base EHR definition, the EHR 

technology must be certified to a 

minimum of nine CQMs for EPs or 16 

CQMs for eligible hospitals and CAHs 

(77 FR 54264 through 54265; see also 45 

CFR 170.102). This is the same number 

required for quality reporting to the 

Medicare and Medicaid EHR Incentive 

Programs, the PQRS EHR reporting and, 

beginning in 2015, the electronic 

reporting option under the Hospital IQR 

Program. In certain cases, an EP, eligible 

hospital or CAH may purchase an EHR 

product that is certified to the minimum 

number of CQMs and discover that, for 

at least one of those CQMs, they do not 

have data on which to report. In these 

cases, the EP (77 FR 54058 through 

54059), eligible hospital or CAH (77 FR 

54051) would report a zero denominator 

for one or more CQMs. 

We believe EHRs should be certified 

to more than the minimum number of 

CQMs required by one or more CMS 

quality reporting programs so that EPs, 

eligible hospitals, and CAHs have a 

choice of which CQMs to report, and 

could therefore choose to report on 

CQMs most applicable to their patient 

population or scope of practice. 

We realize that requiring EHRs to be 

certified to more than the minimum 

number of CQMs required by the 

Medicare and Medicaid EHR Incentive 

Programs may increase the burden on 

EHR vendors. However, in the interest 

of EPs, eligible hospitals, and CAHs 

being able to choose to report eCQMs 

that represent their patient populations, 

we would like to see EP vendors certify 

to all eCQMs that are in the EP selection 

list, or eligible hospital/CAH vendors 

certify to all eCQMs in the selection list 

for those stakeholders. 

We are also considering a phased 

approach such that the number of CQMs 

required for the vendors to have 

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certified would increase each year until 

EHR products are required to certify all 

CQMs required for reporting by EPs, 

eligible hospitals, and CAHs. For 

example, in year one of this phased 

plan, we might require that EHRs be 

certified to at least 18 of 64 available 

CQMs for EPs and 22 of 29 available 

CQMs for eligible hospitals and CAHs; 

in year two, we might require at least 36 

CQMs for EPs and all 29 CQMs for 

eligible hospitals and CAHs; in 

subsequent years of the plan, we would 

increase the number of required CQMs 

for EPs until the EHR is certified to all 

applicable CQMs for EPs, eligible 

hospitals, and CAHs. 

We have also considered alternate 

plans that would require EHRs to be 

certified to more than the minimum 

number of CQMs required for reporting, 

but would not require the EHR to be 

certified to all available CQMs. For 

example, we might require that EHRs be 

certified to a certain core set of CQMs 

plus an additional 9 CQMs for EPs, and 

a certain core set of CQMs plus an 

additional 16 CQMs for eligible 

hospitals and CAHs, which the EHR 

vendor could choose from the list of 

available CQMs. 

We note that the specifics of this plan 

would be outlined in separate noticeand-comment rulemaking such as the 

PFS or IPPS rules. We specifically seek 

comment on this issue of a plan to 

increase the number of CQMs to which 

an EHR is certified. 

6. Electronic Reporting of CQMs 

As previously stated in the Medicare 

and Medicaid EHR Incentive Programs 

Stage 2 final rule (77 FR 54051 through 

54053), CQM data submitted by EPs, 

eligible hospitals, and CAHs are 

required to be captured, calculated and 

reported using certified EHR 

technology. We received numerous 

questions from stakeholders expressing 

confusion over what it means to capture 

data in certified EHR technology. 

Specifically, stakeholders question 

whether they may manually abstract 

data into the EHR from a patient’s chart. 

We do not consider the manual 

abstraction of data from the EHR to be 

capturing the data using certified EHR 

technology. We believe that electronic 

information interfaced or electronically 

transmitted from non-certified EHR 

technology, such as lab information 

systems, automated blood pressure 

cuffs, and electronic scales, into the 

certified EHR, would satisfy the 

‘‘capture’’ requirement, as long as that 

data is visible to providers in the EHR. 

C. Demonstration of Meaningful Use 

and Other Issues 

1. Demonstration of Meaningful Use 

a. Common Methods of Demonstration 

in Medicare and Medicaid 

We are proposing 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. 

b. Methods for Demonstration of the 

Stage 3 Criteria of Meaningful Use for 

2017 and Subsequent Years 

We are proposing to continue the use 

of attestation as the method for 

demonstrating that an EP, eligible 

hospital, or CAH has met the Stage 3 

objectives and measures of meaningful 

use. We are proposing to continue the 

existing optional batch file process for 

attestation in lieu of individual 

Medicare EP attestation through our 

registration and attestion system. This 

batch reporting process ensures 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 (77 FR 54089). 

We would continue to leave open the 

possibility for CMS and the states to test 

options for demonstrating meaningful 

use that utilize existing and emerging 

HIT products and infrastructure 

capabilities. These options could 

involve the use of registries or the direct 

electronic reporting of measures 

associated with the objectives of 

meaningful use. We would not require 

any EP, eligible hospital, or CAH to 

participate in this testing in order to 

receive an incentive payment or avoid 

the payment adjustment. 

For 2017 only, we are proposing 

changes to the attestation process for the 

meaningful use objectives and 

measures, which would allow flexibility 

for providers during this transitional 

year. These proposals are supported by 

a similar flexibility proposed in the 

requirements for the Edition of CEHRT 

a provider may use in 2017 as further 

discussed in section II.A.I.C.(1).(b).(3). 

of this proposed rule. In addition, we 

discuss the attestation changes proposed 

for CQM reporting in detail under 

section II.B.2.a. of this proposed rule. 

(1) Meaningful Use Objective and 

Measures in 2017 

In order to allow all providers to 

successfully transition to Stage 3 of 

meaningful use for a full year-long EHR 

reporting period in 2018, we are 

proposing to allow flexibility for the 

EHR Incentive Programs in 2017. This 

transition period would allow providers 

to establish and test their processes and 

workflows for Stage 3 of meaningful use 

prior to 2018. Specifically, for 2017, we 

are proposing that providers may either 

repeat a year at their current stage or 

move up stage levels. However, for 

2017, a provider may not move 

backward in their progression. Under 

this proposal, providers who 

participated in Stage 1 in 2016 may 

choose to attest to the Stage 1 objective 

and measures, or they may move on to 

Stage 2 or Stage 3 objectives and 

measures for an EHR reporting period in 

2017. Providers who participated in 

Stage 2 in 2016 may choose to attest to 

the Stage 2 objectives and measures or 

move on to Stage 3 objectives and 

measures for an EHR reporting period in 

2017. However, under no 

circumstances, may providers return to 

Stage 1. In 2018, all providers, 

regardless of their prior participation or 

the stage level chosen in 2017, would be 

required to attest to Stage 3 objectives 

and measures for an EHR reporting 

period in 2018. 

(2) CEHRT and Stage Flexibility in 2017 

Based on the delays providers 

experienced with fully implementing 

the EHR technology certified to the 2014 

Edition (as further described in the 2014 

CEHRT Flexibility final rule (79 FR 

52910 through 52933) we believe it is 

necessary to preemptively prepare for 

the upgrade to EHR technology certified 

to the 2015 Edition and the transition to 

Stage 3. Preparation for the upgrade 

would ensure that providers and 

developers have adequate time to 

certify, install, fully implement the 

software, and establish the processes 

and workflows for the objectives and 

measures for providers moving to the 

next stage of the EHR Incentive 

Programs. Accordingly, we propose 

allowing providers flexible CEHRT 

options for 2017. These options may 

impact the selection of objectives and 

measures to which a provider can attest. 

Specifically, under the CEHRT options 

for 2017, we propose that providers 

would have the option to continue to 

use EHR technology certified to the 

2014 Edition, in whole or in part, for an 

EHR reporting period in 2017. We note 

that providers who use only the EHR 

technology certified to the 2014 Edition 

for an EHR reporting period in 2017 

may not choose to attest to the Stage 3 

objectives and measures as those 

objectives and measures require the 

support of EHR technology certified to 

the 2015 Edition. 

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Providers using only EHR technology 

certified in whole or in relevant part to 

the 2014 Edition certification criteria 

may attest to the objectives and 

measures of meaningful use in the 

following manner: 

• If a provider first demonstrated 

meaningful use in 2015 or 2016, they 

may attest to Stage 1 objectives and 

measures or Stage 2 objectives and 

measures. 

• If a provider first demonstrated 

meaningful use in any year prior to 

2015, they may attest to the Stage 2 

objectives and measures. 

Providers using EHR technology 

certified in whole or in relevant part to 

the 2015 Edition certification criteria 

may elect to attest to the objectives and 

measures of meaningful use in the 

following manner: 

• If a provider first demonstrated 

meaningful use in 2015 or 2016, they 

may attest to Stage 1 objectives and 

measures, Stage 2 objectives and 

measures, or Stage 3 objectives and 

measures if they have all the 2015 

Edition functionality required to meet 

all Stage 3 objectives. 

• If a provider first demonstrated 

meaningful use in any year prior to 

2015, they may attest to Stage 2 

objectives and measures, or Stage 3 

objectives and measures if they have all 

the 2015 Edition functionality required 

to meet all Stage 3 objectives. 

We note that all providers would be 

required to fully upgrade to EHR 

technology certified to the 2015 Edition 

for the EHR reporting period in 2018. 

We also reiterate that providers may 

elect to attest to Stage 3 of the program 

using EHR technology certified to the 

2015 Edition beginning in 2017. We 

further stress that the use of 2011 

CEHRT, although an option under the 

2014 CEHRT Flexibility final rule (79 

FR 52913 through 52914), is not an 

option under this proposal. However, as 

part of this proposal, we would like to 

seek comment on alternate flexibility 

options. Specifically, we are seeking 

comment on whether the flexible option 

to attest to Stages 1 or 2 should be 

limited to only those providers who 

could not fully implement EHR 

technology certified to the 2015 Edition 

in 2017. We are also seeking comment 

on whether those providers with fully 

implemented EHR technology certified 

to the 2015 Edition in 2017 should be 

required to attest to Stage 3 only in 

2017. Finally, we seek comment on 

whether providers should not have the 

option to attest to Stage 3 in 2017 

regardless of an upgrade to EHR 

technology certified to the 2015 Edition 

in 2017, and should instead be required 

to wait to demonstrate Stage 3 until 

2018 using EHR technology certified to 

the 2015 Edition. 

We welcome comments on these 

proposals. 

(3) CQM Flexibility in 2017 

In the 2014 CEHRT Flexibility final 

rule, we did not allow providers to 

separate their CQM reporting selection 

from the year of meaningful use 

objectives they reported on. We did not 

allow this reporting for a number of 

reasons including how we defined 

CQMs, as well as the number of CQMs 

reporting changes occurring between 

Stage 1 in 2011 through 2013, and Stage 

1 and 2 in 2014. For further discussion, 

we direct readers to 79 FR 52927 

through 52930. 

To report CQMs for 2017, we propose 

to allow greater flexibility by proposing 

to split the use of CEHRT for CQM 

reporting from the use of CEHRT for the 

objectives and measures. This means 

that providers would be able to 

separately report CQMs using EHR 

technology certified to the 2015 Edition 

even if they use EHR technology 

certified to the 2014 Edition for the 

meaningful use objectives and measures 

for an EHR reporting period in 2017. 

Providers may also use EHR technology 

certified to the 2015 Edition for their 

meaningful use objectives and measures 

in 2017 and use EHR technology 

certified to the 2014 Edition for their 

CQM reporting for an EHR reporting 

period in 2017. 

For an EHR reporting period in 2017, 

EPs, eligible hospitals, and CAHs may 

choose to report eCQMs electronically 

using the CQMs finalized for use in 

2017 using the most recent version of 

the eCQMs (electronic specifications), 

which would be the electronic 

specifications of the CQMs published by 

CMS in 2016. Alternately, a provider 

may choose to continue to attest to the 

CQMs established for use in 2017 also 

using the most recent (2016 version) 

eCQM electronic specifications. These 

options are available for provider using 

either EHR technology certified to the 

2014 Edition or EHR technology 

certified to the 2015 Edition. These 

flexible options for an EHR reporting 

period in 2017 are further discussed in 

sections II.B.2.a. of this proposed rule. 

An EP, eligible hospital, or CAH must 

use certified EHR technology, 

successfully attest to the meaningful use 

objectives and measures, and 

successfully submit CQMs to be a 

meaningful EHR user. We note that 

states may determine the form and 

method of CQM submission for 

participants in the Medicaid program 

subject to our approval as outline in 

sections II.B.3 and II.F.3. of this 

proposed rule. However, the selection of 

CQMs and the minimum reporting 

period are the same for providers in 

both Medicare and Medicaid as outlined 

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

Similar to our rationale under the 

2014 CEHRT Flexibility final rule (79 

FR 52910 through 52933), we believe 

the proposals outlined for attestation in 

2017 would allow providers the 

flexibility to choose the option which 

applies to their particular circumstances 

and use of CEHRT. Upon attestation, 

providers may select one of the 

proposed options available for their 

participation year and EHR Edition. The 

EHR Incentive Program Registration and 

Attestation System would then prompt 

the provider to attest to meeting the 

objectives, measures, and CQMs 

applicable under that option. We further 

propose that auditors would be 

provided guidance related to reviewing 

attestations associated with the options 

for using CEHRT in 2017, as was done 

for 2014. 

We welcome comment on this 

proposal. 

c. EHR Reporting Period in 2017 and 

Subsequent Years 

We are proposing, with limited 

exceptions outlined in section II.F.1. of 

this proposed rule, that the EHR 

reporting period in 2017 would be a full 

calendar year for all providers. We 

encourage providers to begin Stage 3 in 

2017. However, under the current 

timeline shown in Table 3, we recognize 

that providers first demonstrating 

meaningful use under Stage 1 in 2016 or 

2017 or under Stage 2 in 2016 or 2017 

must begin Stage 3 in 2018. We further 

recognize providers scheduled to begin 

Stage 3 in 2017 that instead choose to 

meet the Stage 2 criteria in 2017 must 

begin Stage 3 in 2018. However, in 

2018, all providers, except as outlined 

in section II.F.1. of this proposed rule, 

must report based on a full calendar 

year EHR reporting period for the Stage 

3 objectives and measures. In addition, 

in 2018, all providers must use EHR 

technology certified to the 2015 Edition 

for the full EHR reporting period in 

order to successfully demonstrate 

meaningful use. 

For CQM reporting in 2018 and 

subsequent years, as outlined in section 

II.B.3 of this proposed rule, we are 

proposing that providers participating 

in the Medicare program must 

electronically report, where feasible, 

and that attestation to CQMs would no 

longer be an option except in 

circumstances where electronic 

reporting is not feasible. This would 

include providers facing circumstances 

which render them unable to 

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electronically report (such as a data 

submission system failure, natural 

disaster, or certification issue outside 

the control of the provider) who may 

attest to CQMs if they also attest that 

electronically reporting was not feasible 

for their demonstration of meaningful 

use for a given year. 

We welcome public comment on this 

proposal. 

2. Data Collection for Online Posting, 

Program Coordination, and Accurate 

Payments 

We propose to continue posting Stage 

1 and Stage 2 aggregate and individual 

performance and participation data 

resulting from the EHR Incentive 

programs online regularly for public 

use. We further note our intent to 

potentially publish the performance and 

participation data on Stage 3 objectives 

and measures of meaningful use in 

alignment with quality programs which 

utilize publicly available performance 

data such as physician compare. 

In addition to the data already being 

collected under our regulations, as 

outlined in section III. of this proposed 

rule, we propose to collect the following 

information from providers to ensure 

providers keep their information up-todate through the system of record for 

their National Provider Identifier (NPI) 

in the National Plan & Provider 

Enumeration System: 

• Primary Practice Address (address, 

city, state zip, country code, etc.). 

• Primary Business/Billing Address 

(address, city, state, zip, country code, 

etc.). 

• Primary License information (for 

example, provide medical license in at 

least one state (or territory)). 

• Contact Information (phone 

number, fax number, and contact email 

address). 

• Health Information Exchange 

Information: 

++ Such as DIRECT address required 

(if available). 

++ If DIRECT address is not available, 

Electronic Service Information is 

required. 

++ If DIRECT address is available, 

Electronic Service Information is 

optional in addition to DIRECT address. 

We do not propose any changes to the 

registration for the Medicare and 

Medicaid EHR Incentive Programs. 

3. 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 

sections II.B.1. through II.B.6. of this 

proposed rule for the proposed 

alignment initiatives for CQMs. 

D. Payment Adjustments and Hardship 

Exceptions 

Sections 4101(b) and 4102(b) of the 

HITECH Act, amending sections 1848, 

1853, and 1886 of the Act, require 

reductions in payments to EPs, eligible 

hospitals, and CAHs that are not 

meaningful users of certified EHR 

technology, beginning in CY 2015 for 

EPs, FY 2015 for eligible hospitals, and 

in cost reporting periods beginning in 

FY 2015 for CAHs. 

1. Statutory Basis for Payment 

Adjustment and Hardship Exceptions 

for EPs 

Section 1848(a)(7) of the Act provides 

for payment adjustments, effective for 

CY 2015 and subsequent years, for EPs 

as defined in 42 CFR 495.100, who are 

not meaningful EHR users during the 

relevant EHR reporting period for the 

year. Section 1848(a)(7) provides that 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’’ of the fee schedule amount 

that would otherwise apply. The term 

‘‘applicable percent’’ is defined in 

section 1848(a)(7)(A)(ii) of the Act as: (I) 

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

an EP who was subject to the 

application of the payment adjustment 

[if the EP was not a successful electronic 

prescriber] under section 1848(a)(5) of 

the Act for 2014, 98 percent); (II) for 

2016, 98 percent; and (III) for 2017 and 

each subsequent year, 97 percent. 

In addition, section 1848(a)(7)(A)(iii) 

of the Act provides that if, for CY 2018 

and subsequent years, the Secretary 

finds 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. 

We established regulations 

implementing these statutory provisions 

under 42 CFR 495.102. We refer readers 

to the final rules for Stages 1 and 2 (75 

FR 44442 through 44448 and 77 FR 

54093 through 54102) for more 

information. 

2. EHR Reporting Period for 

Determining Whether an EP Is Subject 

to the Payment Adjustment for CY 2018 

and Subsequent Calendar Years 

Section 1848(a)(7)(E)(ii) of the Act 

provides the Secretary with broad 

authority to choose the EHR reporting 

period that will apply for purposes of 

determining the payment adjustments 

for CY 2015 and subsequent years. In 

the Stage 2 final rule (77 FR 54095 

through 54097), we adopted a policy 

that the EHR reporting periods for the 

payment adjustments will begin and 

end prior to the year of the payment 

adjustment. We stated that this is based 

on our desire 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, 

and the resulting implications for 

beneficiary coinsurance. 

Specifically, we finalized under 

§ 495.4 of the regulations that for EPs, 

the EHR reporting period for a payment 

adjustment year is the full calendar year 

that is 2 years before the payment 

adjustment year. For example, the full 

calendar year of 2015 would be the EHR 

reporting period for the CY 2017 

payment adjustment year. We also 

finalized an exception to this rule for 

EPs who have never successfully 

attested to meaningful use. Stated 

generally, under this exception, for an 

EP who is demonstrating meaningful 

use for the first time, the EHR reporting 

period for a payment adjustment year is 

any continuous 90-day period. For a full 

description of this exception, including 

limitations on when the continuous 90- 

day period must occur in relation to the 

payment adjustment year and the 

deadlines for registration and 

attestation, we refer readers to the 

definition of ‘‘EHR reporting period for 

a payment adjustment year’’ under 

§ 495.4 of the regulations and the 

discussion in the Stage 2 final rule (77 

FR 54095 through 54096). We 

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established that these policies apply for 

the CY 2015 payment adjustment year 

and subsequent payment adjustment 

years. 

However, in this Stage 3 proposed 

rule, we propose to eliminate the 

exception discussed previously for a 90- 

day EHR reporting period for new 

meaningful EHR users beginning with 

the EHR reporting period in 2017, with 

a limited exception for Medicaid EPs 

demonstrating meaningful use for the 

first time. We propose that for EPs who 

have successfully demonstrated 

meaningful use in a prior year as well 

as those who have not, the EHR 

reporting period for a payment 

adjustment year would be the full 

calendar year that is 2 years before the 

payment adjustment year. For example, 

for all EPs demonstrating meaningful 

use, the full CY 2017 would be the EHR 

reporting period for the CY 2019 

payment adjustment year. To avoid a 

payment adjustment in CY 2019, EPs 

must demonstrate meaningful use of 

certified EHR technology for an EHR 

reporting period of the entire CY 2017. 

This policy would continue to apply in 

subsequent years. 

As discussed in sections II.A.1.a. and 

II.F.1. of this proposed rule, we are 

proposing to maintain a 90-day EHR 

reporting period for the first payment 

year based on meaningful use for 

Medicaid EPs demonstrating meaningful 

use for the first time. We recognize that 

these EPs may be subject to payment 

adjustments under Medicare if they fail 

to demonstrate meaningful use, and 

thus we propose that the same 90-day 

EHR reporting period used for the 

Medicaid incentive payment would also 

apply for purposes of the Medicare 

payment adjustment for the payment 

adjustment year two years after the 

calendar year in which the provider 

demonstrates meaningful use. We note 

under our current policy, if an EP has 

never successfully demonstrated 

meaningful use, the EHR reporting 

period for a payment adjustment year is 

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. We do not propose to 

maintain this policy, and thus for 

Medicaid EPs who are new meaningful 

EHR users, the 90-day EHR reporting 

period for a payment adjustment year 

must occur within the calendar year that 

is 2 years before the payment 

adjustment year. These proposals for 

Medicaid EPs would apply beginning 

with the EHR reporting period in CY 

2017. 

We provide the following example: 

Example A: If an EP has never 

successfully demonstrated meaningful 

use prior to CY 2017 and demonstrates 

under the Medicaid EHR Incentive 

Program that he or she is a meaningful 

EHR user for the first time in CY 2017, 

the EHR reporting period for the 

Medicaid incentive payment would be 

any continuous 90-day period within 

CY 2017. The same 90-day period 

would also serve as the EHR reporting 

period for the CY 2019 payment 

adjustment year under Medicare. This 

90-day period would not serve as the 

EHR reporting period for the CY 2018 

payment adjustment year under 

Medicare even if the EP registers for and 

attests to meaningful use by October 1, 

2017. The EP would have to 

demonstrate meaningful use for an EHR 

reporting period of the full CY 2018 to 

earn an incentive payment under 

Medicaid for the CY 2018 payment year 

and avoid the payment adjustment 

under Medicare for the CY 2020 

payment adjustment year. 

We propose these changes to further 

our goal to align reporting requirements 

under the EHR Incentive Program and 

the reporting requirements for various 

CMS quality reporting programs, to 

respond to stakeholders who cited 

difficulty with following varying 

reporting requirements, and to simplify 

HHS system requirements for data 

capture. We further note that newly 

practicing EPs have the ability to apply 

for a hardship exception from the 

Secretary under § 495.102(d)(4)(ii), 

which provides for an exception from 

the payment adjustments for the 2 years 

after they begin practicing. We propose 

amendments to the definition of ‘‘EHR 

reporting period for a payment 

adjustment year’’ under § 495.4 to 

reflect these proposals. We welcome 

public comments on this proposal. 

3. Exception to the Application of the 

Payment Adjustment to EPs in CY 2017 

and Subsequent Years 

As previously discussed, sections 

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 adjustment 

in CY 2015 and subsequent calendar 

years if the Secretary determines that 

compliance with the requirements for 

being a meaningful EHR user will result 

in a significant hardship, such as an EP 

who practices in a rural area without 

sufficient internet access. As provided 

by 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. The statute does not 

require the Secretary to grant 

exceptions. However, as we stated in the 

Stage 2 final rule at 77 FR 54097, we 

believe that certain circumstances 

evidence the existence of a hardship, 

thereby justifying the need for an 

exception by the Secretary. Therefore, in 

the Stage 2 final rule, we finalized 

various types of hardship exceptions 

that EPs could apply for, which 

included insufficient internet access, 

newly practicing EPs, extreme 

circumstances outside of an EP’s 

control, lack of control over the 

availability of CEHRT for EPs practicing 

in multiple locations, lack of face-toface patient interactions and lack of 

need for follow-up care, and certain 

primary specialties. For further 

discussion of the hardship exceptions, 

we refer readers to the Stage 2 final rule 

at 77 FR 54097 through 54101 and 42 

CFR 495.102(d)(4). 

In this Stage 3 proposed rule, we 

propose no changes to the types of 

exceptions previously finalized for EPs, 

nor do we propose any new types of 

exceptions for 2017 and subsequent 

years. Accordingly, we propose that the 

exceptions continue as previously 

finalized. 

4. Statutory Basis for Payment 

Adjustments and Hardship Exceptions 

for Eligible Hospitals 

Section 1886(b)(3)(B)(ix)(I) of the Act, 

as amended by section 4102(b)(1) of the 

HITECH Act, provides for an adjustment 

to the applicable percentage increase to 

the IPPS payment rate for those eligible 

hospitals that are not meaningful EHR 

users for the associated EHR reporting 

period for a payment adjustment year, 

beginning in FY 2015. Specifically, 

section 1886(b)(3)(B)(ix)(I) of the Act 

provides that, for FY 2015 and each 

subsequent fiscal year, 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 applies to ‘‘three-quarters of 

the percentage increase otherwise 

applicable’’ prior to the application of 

statutory adjustments under sections 

1886(b)(3)(B)(viii), 1886(b)(3)(B)(xi), and 

1886(b)(3)(B)(xii) of the Act, or threequarters of the applicable market basket 

update. 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 

must reduce the applicable percentage 

increase (prior to the application of 

other statutory adjustments) by 25 

percent (331⁄3 of 75 percent) in FY 2015, 

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50 percent (662⁄3 percent of 75 percent) 

in FY 2016, and 75 percent (100 percent 

of 75 percent) in FY 2017 and 

subsequent years. Section 4102(b)(1)(B) 

of the HITECH Act also provides that 

the reduction shall apply only with 

respect to the fiscal year involved and 

the Secretary shall not take into account 

such reduction in computing the 

applicable percentage increase for a 

subsequent fiscal year. 

Section 1886(b)(3)(B)(ix)(II) of the Act, 

as amended by Section 4102(b)(1) of the 

HITECH Act, provides that the Secretary 

may, on a case-by-case basis, exempt a 

hospital from the application of the 

applicable percentage increase 

adjustment for a fiscal year if the 

Secretary determines that requiring such 

hospital to be a meaningful EHR user 

will result in a significant hardship, 

such as in the case of a hospital in a 

rural area without sufficient internet 

access. This section also provides that 

such determinations are subject to 

annual renewal, and that in no case may 

a hospital be granted an exception for 

more than 5 years. 

5. Applicable Market Basket Update 

Adjustment for Eligible Hospitals That 

Are Not Meaningful EHR Users for FY 

2019 and Subsequent Fiscal Years 

Section 412.64(d) of the regulations 

sets forth the adjustment to the 

percentage increase in the market basket 

index for those eligible hospitals that 

are not meaningful EHR users for the 

EHR reporting period for a payment 

year, beginning in FY 2015. 

6. EHR Reporting Period for 

Determining Whether a Hospital Is 

Subject to the Market Basket Update 

Adjustment for FY 2018 and Subsequent 

Fiscal Years 

Section 1886(b)(3)(B)(ix)(IV) of the 

Act makes clear that the Secretary has 

discretion to specify as the EHR 

reporting period ‘‘any period (or 

periods)’’ that will apply ‘‘with respect 

to a fiscal year.’’ In the Stage 2 final rule 

at 77 FR 54104 through 54105, we 

finalized the applicable EHR reporting 

period for purposes of determining 

whether an eligible hospital is subject to 

the payment adjustment. 

As with EPs, we finalized that the 

EHR reporting period for the payment 

adjustment year for eligible hospitals 

will begin and end prior to the year of 

the payment adjustment. We finalized 

under § 495.4 of the regulations that for 

eligible hospitals, the EHR reporting 

period for a payment adjustment year is 

the full federal fiscal year that is 2 years 

before the payment adjustment year. We 

established this policy beginning with 

the FY 2015 payment adjustment year 

and continuing in subsequent years. For 

example, the full federal fiscal year of 

2015 would be the EHR reporting period 

for the FY 2017 payment adjustment 

year. However, in this Stage 3 proposed 

rule, beginning in 2017, we propose to 

change the EHR reporting period for a 

payment adjustment year for eligible 

hospitals from a fiscal year basis to a 

calendar year basis. Specifically, we 

propose to revise the definition of ‘‘EHR 

reporting period for a payment 

adjustment year’’ under § 495.4 such 

that the EHR reporting period for a 

payment adjustment year for an eligible 

hospital would be the full calendar year 

that is 2 years before the payment 

adjustment year. For example, the entire 

CY 2017 would be the EHR reporting 

period used to determine whether the 

payment adjustment would apply for an 

eligible hospital for FY 2019. This 

change would apply beginning with the 

CY 2017 EHR reporting period for 

purposes of the FY 2019 payment 

adjustment year, and continue to apply 

in subsequent years. We note that 

eligible hospitals would have ample 

time to adjust to the new calendar year 

reporting timeframe given that under 

our current policy, the EHR reporting 

period occurs prior to the payment 

adjustment year. We further believe that 

aligning all providers, including eligible 

hospitals, to a calendar year EHR 

reporting timeframe for purposes of the 

payment adjustment, would simplify 

reporting for all providers, especially for 

larger providers with diverse systems 

and groups. In addition, placing all 

providers, including eligible hospitals, 

onto a calendar year timeframe would 

further simplify HHS system 

requirements for data capture and 

would move the EHR Incentive Program 

another step closer to alignment with 

various CMS quality reporting 

programs. We welcome comments on 

this proposal. 

Further, in the Stage 2 final rule, we 

finalized an exception to the general 

rule of a full federal fiscal year EHR 

reporting period for eligible hospitals 

that have never successfully attested to 

meaningful use. Stated generally, under 

this exception, for an eligible hospital 

that is demonstrating meaningful use for 

the first time, the EHR reporting period 

for a payment adjustment year is any 

continuous 90-day period. For a full 

description of this exception, including 

limitations on when the continuous 90- 

day period must occur in relation to the 

payment adjustment year and the 

deadlines for registration and 

attestation, we refer readers to the 

definition of ‘‘EHR reporting period for 

a payment adjustment year’’ under 

§ 495.4 of the regulations and the 

discussion in the Stage 2 final rule (77 

FR 54104 and 54105). 

However, in this Stage 3 proposed 

rule, we propose to eliminate this 

exception for eligible hospitals that are 

new meaningful EHR users beginning 

with the EHR reporting period in 2017, 

with a limited exception for Medicaid 

eligible hospitals demonstrating 

meaningful use for the first time. As 

explained previously, we propose that 

for eligible hospitals that have 

successfully demonstrated meaningful 

use in a prior year as well as those that 

have not, the EHR reporting period for 

a payment adjustment year would be the 

full calendar year that is 2 years before 

the payment adjustment year. For 

example, for all eligible hospitals, the 

full CY 2017 would be the EHR 

reporting period for the FY 2019 

payment adjustment year. This policy 

would continue to apply in subsequent 

years. 

Though, as discussed in sections 

II.A.1.a. and II.F.1. of this proposed rule, 

for Medicaid eligible hospitals 

demonstrating meaningful use for the 

first time, we are proposing to maintain 

a 90-day EHR reporting period for the 

first payment year based on meaningful 

use. We recognize that these eligible 

hospitals may be subject to payment 

adjustments under Medicare if they fail 

to demonstrate meaningful use, and 

thus we propose that the same 90-day 

EHR reporting period used for the 

Medicaid incentive payment would also 

apply for purposes of the Medicare 

payment adjustment for the payment 

adjustment year 2 years after the 

calendar year in which the provider 

demonstrates meaningful use. We note 

under our current policy, if an eligible 

hospital has never successfully 

demonstrated meaningful use, the EHR 

reporting period for a payment 

adjustment year is any continuous 90- 

day period that both begins in the 

federal fiscal year 1 year before the 

payment adjustment year and ends at 

least 3 months before the end of such 

prior year. We do not propose to 

maintain this policy, and thus for 

Medicaid eligible hospitals that are new 

meaningful EHR users, the 90-day EHR 

reporting period for a payment 

adjustment year must occur within the 

calendar year that is 2 years before the 

payment adjustment year. These 

proposals for Medicaid eligible 

hospitals would apply beginning with 

the EHR reporting period in CY 2017. 

We provide the following example: 

Example A: If an eligible hospital has 

never successfully demonstrated 

meaningful use prior to CY 2017 and 

demonstrates under the Medicaid EHR 

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Incentive Program that it is a 

meaningful EHR user for the first time 

in CY 2017, the EHR reporting period 

for the Medicaid incentive payment 

would be any continuous 90-day period 

within CY 2017. The same 90-day 

period would also serve as the EHR 

reporting period for the FY 2019 

payment adjustment year under 

Medicare. This 90-day period would not 

serve as the EHR reporting period for 

the FY 2018 payment adjustment year 

under Medicare even if the eligible 

hospital registers for and attests to 

meaningful use by July 1, 2017. The 

eligible hospital would have to 

demonstrate meaningful use for an EHR 

reporting period of the full CY 2018 to 

earn an incentive payment under 

Medicaid for the 2018 payment year and 

avoid the payment adjustment under 

Medicare for the FY 2020 payment 

adjustment year. 

Like our proposal to move eligible 

hospitals to a calendar year timeframe, 

we believe that removing the 

continuous 90-day EHR reporting period 

for most eligible hospitals would 

simplify reporting for providers, 

especially those hospitals with diverse 

groups and systems. In addition, 

eliminating the 90-day EHR reporting 

period would move the EHR Incentive 

Program one step closer to alignment 

within the program and with CMS 

quality reporting programs and would 

simplify HHS system requirements for 

data capture. Therefore, moving eligible 

hospitals to a calendar year EHR 

reporting period for the payment 

adjustment years, as well as requiring 

all providers (EPs and hospitals) to 

report based on the same full year 

calendar timeframe would accomplish 

these goals and be responsive to prior 

public comments asking us to simplify 

the EHR Incentive Program. 

We propose amendments to the 

definition of ‘‘EHR reporting period for 

a payment adjustment year’’ under 

§ 495.4 to reflect these proposals. 

We note that hospitals that are eligible 

under both the Medicaid and Medicare 

incentive programs, and that are 

attesting for the Medicaid program, do 

not need to separately attest in the 

Medicare program in 2017 and 

subsequent years, because the statute 

does not allow for Medicare EHR 

incentive payments to eligible hospitals 

after FY 2016. If a hospital eligible 

under both programs is demonstrating 

meaningful use for the first time, and 

using a continuous 90-day EHR 

reporting period under the Medicaid 

program, it could attest for the Medicaid 

program only, and still avoid the 

Medicare payment adjustment that is 2 

years after the calendar year in which 

the EHR reporting period occurs. 

However, if a hospital eligible under 

both programs chooses also to attest for 

the Medicare program, it would be 

required to complete an EHR reporting 

period of 1 full calendar year to avoid 

the Medicare payment adjustment that 

is 2 years after that calendar year. 

We welcome public comments on 

these proposals. 

7. Exception to the Application of the 

Market Basket Update Adjustment to 

Hospitals in FY 2019 and Subsequent 

Fiscal Years 

As stated 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 

payment adjustment for a fiscal year if 

the Secretary determines that 

compliance with the requirements for 

being a meaningful EHR user will result 

in a significant hardship, such as an 

eligible hospital located in a rural area 

without sufficient internet access. 

Section 1886(b)(3)(B)(ix)(III) also 

provides that the exception is subject to 

annual renewal, but in no case may a 

hospital be granted an exception for 

more than 5 years. The Secretary’s 

hardship exception authority is 

discretionary. 

As we explained in the Stage 2 final 

rule at 77 FR 54105 through 54106, we 

believe that certain circumstances may 

constitute a hardship that would 

warrant the Secretary’s use of the 

exception authority. Therefore, in the 

Stage 2 final rule, we finalized various 

types of hardship exceptions for which 

eligible hospitals may apply, which 

included lack of insufficient internet 

access, extreme circumstances outside 

of a hospital’s control, and the 

establishment of new hospitals. For 

further discussion of the hardship 

exceptions, we refer readers to the Stage 

2 final rule at 77 FR 54105 through 

54108 as well as 42 CFR 412.64(d)(4). 

In this Stage 3 proposed rule, we 

propose no changes to the types of 

exceptions previously finalized for 

eligible hospitals, nor do we propose 

any new exceptions for eligible 

hospitals. Accordingly, for Stage 3, we 

propose to continue the hardship 

exceptions for 2017 and subsequent 

years as previously finalized. 

8. Statutory Basis for Payment 

Adjustments to CAHs 

Section 4102(b)(2) of the HITECH Act 

amended section 1814(l) of the Act to 

include an adjustment to a CAH’s 

Medicare reimbursement for inpatient 

services if the CAH is not a meaningful 

EHR user for an EHR reporting period. 

The adjustment will be made for cost 

reporting periods that begin in FY 2015, 

FY 2016, FY 2017, and each subsequent 

FY thereafter. Specifically, sections 

1814(l)(4)(A) and (B) of the Act provide 

that, if a CAH does not demonstrate 

meaningful use of CEHRT for an 

applicable EHR reporting period, then 

for a cost reporting period beginning in 

FY 2015, the CAH’s reimbursement 

shall be reduced from 101 percent of its 

reasonable costs to 100.66 percent of 

reasonable costs. 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 fiscal 

year, 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 this exception for more than 5 

years. 

9. 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 

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 

In Stage 2, we amended the definition 

of the EHR reporting period that would 

apply for purposes of the payment 

adjustment for CAHs under § 495.4 (77 

FR 54109 and 54110). For CAHs, this is 

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 EHR reporting 

period within the payment adjustment 

year would apply). The adjustment 

applies based upon the cost reporting 

period that begins in the payment 

adjustment year (that is, FY 2015 and 

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thereafter). Thus, if a CAH is not a 

meaningful EHR user for FY 2015, and 

thereafter, then the payment adjustment 

is applied to the CAH’s reasonable costs 

incurred in a cost reporting period that 

begins in the affected fiscal year as 

described in § 413.70(a)(6)(i). We further 

finalized that CAHs submit their 

attestations on meaningful use by 

November 30 of the following fiscal 

year. 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, will then affect interim 

payments to the CAH made after 

December 1 of the applicable fiscal year. 

If the cost reporting period ends prior to 

December 1 of the applicable fiscal year, 

then any applicable payment 

adjustment will be made through the 

cost report settlement process. 

Under this Stage 3 proposed rule, we 

are proposing a change to the EHR 

reporting period that would apply for 

the payment adjustments for CAHs, 

beginning with the FY 2017 payment 

adjustment year. First, similar to what 

we proposed for eligible hospitals 

previously, we propose that the EHR 

reporting period for a payment 

adjustment year for CAHs would be a 

full calendar year, rather than a full 

federal fiscal year. We propose the EHR 

reporting period for a payment 

adjustment year would be the calendar 

year that overlaps the last 3 quarters of 

the federal fiscal year that is the 

payment adjustment year. For example, 

in order for a CAH to avoid application 

of the adjustment to its reasonable costs 

incurred in a cost reporting period that 

begins in FY 2017, the CAH must 

demonstrate it is a meaningful EHR user 

for an EHR reporting period of the full 

CY 2017. This proposed change would 

mean that the EHR reporting period 

would no longer precisely align with the 

payment adjustment year. We propose 

amendments to the definition of ‘‘EHR 

reporting period for a payment 

adjustment year’’ under § 495.4 to 

reflect these proposals. 

In the Stage 2 final rule, we note the 

process for the implementation of a 

payment adjustment to CAH cost reports 

in relation to the EHR reporting period 

attestation deadline (77 FR 54109 and 

54110). Under our Stage 3 proposal, we 

would need to move the CAH attestation 

deadline in order to accommodate the 

change to a calendar year-based EHR 

reporting period. Therefore, we propose 

to move the CAH attestation deadline to 

the last day in February following the 

end of the EHR reporting period as we 

currently allow for EPs. Any accounting 

shifts that occur as a result from the 

change to a calendar year-based EHR 

reporting period can be accommodated 

through the cost reporting and 

settlement process. The CAH must attest 

no later than 2 months (February 28 or 

February 29 if applicable) following the 

close of the EHR reporting period at the 

end of each calendar year to avoid the 

payment adjustment. Such an 

attestation or lack thereof, will then 

affect interim payments to the CAH 

made after March 1 of the applicable 

federal fiscal year. If the cost reporting 

period ends prior to March 1 of the 

applicable fiscal year, then any 

applicable payment adjustment will be 

made through the cost report settlement 

process. 

We are proposing this change to the 

EHR reporting period for the payment 

adjustment year to further align most 

providers to a calendar year-based EHR 

reporting period. We believe that the 

change to calendar year reporting for 

CAHs is feasible given that the cost 

reporting and cost settlement processes 

is unique to CAHs under the Medicare 

EHR Incentive Program. Unlike eligible 

hospitals or EPs, who use a claims 

processing system to determine the 

payment adjustment under the Medicare 

EHR Program, CAHs are required to file 

an annual Medicare cost report that is 

typically for a consecutive 12-month 

period. The cost report reflects the 

inpatient statistical and financial data 

that forms the basis of the CAH’s 

Medicare reimbursement. Interim 

Medicare payment 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 the 

reconciliation and settlement process 

prior to a final Medicare payment being 

made. The proposed change to a 

calendar year EHR reporting period for 

CAHs would not significantly impact 

the ability to implement the payment 

adjustments in the cost report 

reconciliation process for either CAHs 

or CMS. It would only shift the potential 

date where the reconciliation of any 

payment adjustment in the cost 

reporting process may occur. These 

payments would still be subject to the 

reconciliation and settlement process 

prior to a final Medicare payment being 

made. 

For example, currently CAHs must 

file their attestations on meaningful use 

by November 30 of the federal fiscal 

year following the close of the federal 

fiscal year in which the EHR reporting 

period occurs. Under our current 

system, if a CAH is attesting that it was 

a meaningful EHR user for FY 2015, the 

attestation must be submitted not later 

than November 30, 2015. A payment 

adjustment applied if the CAH does not 

successfully attest would affect interim 

payment to the CAH made after 

December 1 of 2015. If the cost reporting 

period ends prior to December 1, 2015, 

then any applicable payment 

adjustment will be made under the cost 

reporting settlement process. 

In an example of a similar scenario 

under the new proposal, a CAH that 

does not successfully demonstrate 

meaningful use based on a calendar year 

EHR reporting period in 2017 (January 

1, 2017 through December 31, 2017) 

would be subject to a payment 

adjustment applied to its reasonable 

costs incurred in the cost reporting 

period beginning in FY 2017 (October 1, 

2017 through September 30, 2018). To 

avoid the payment adjustment in this 

example, the CAH must attest no later 

than February 28, 2018 to demonstrate 

meaningful use for an EHR reporting 

period in 2017. If the CAH does not 

attest by February 28, 2018, a payment 

adjustment would then affect interim 

payments to the CAH made after March 

1, 2018. If the cost reporting period ends 

prior to March 1, 2018, then any 

applicable payment adjustment would 

be made through the cost report 

settlement process. We note that this is 

reflective of a similar policy in the Stage 

2 final rule addressing the process for 

CAH payment adjustments with an 

attestation deadline of November 30 in 

a given year and direct readers to 77 FR 

54110 for further information on this 

policy. 

Second, as noted previously, and 

outlined in the definition of ‘‘EHR 

reporting period for a payment 

adjustment year’’ under § 495.4, we 

established an exception for first-time 

CAH meaningful EHR users. Under our 

current policy, if a CAH is 

demonstrating it is a meaningful EHR 

user for the first time in the payment 

adjustment year, the applicable EHR 

reporting period is any continuous 90- 

day period within the federal fiscal year 

that is the payment adjustment year. 

For this Stage 3 proposed rule, we 

propose to eliminate this exception for 

CAHs that are new meaningful EHR 

users beginning with the EHR reporting 

period in 2017, with a limited exception 

for CAHs demonstrating meaningful use 

for the first time under the Medicaid 

EHR Incentive Program. As discussed in 

II.A.1.a. and II.F.1. of this proposed rule, 

for CAHs that demonstrate meaningful 

use for the first time under Medicaid, 

we are proposing to maintain a 90-day 

EHR reporting period for the first 

payment year based on meaningful use. 

We recognize that these CAHs may be 

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subject to payment adjustments under 

Medicare if they fail to demonstrate 

meaningful use, and thus we propose 

that the same 90-day EHR reporting 

period used for the Medicaid incentive 

payment would also apply for purposes 

of the Medicare payment adjustment. 

We propose amendments to the 

definition of ‘‘EHR reporting period for 

a payment adjustment year’’ under 

§ 495.4 to reflect these proposals. 

Example A: If a CAH has never 

successfully demonstrated meaningful 

use prior to CY 2017 and demonstrates 

under the Medicaid EHR Incentive 

Program that it is a meaningful EHR 

user for the first time in CY 2017, the 

EHR reporting period for the Medicaid 

incentive payment would be any 

continuous 90-day period within CY 

2017. The same 90-day period would 

also serve as the EHR reporting period 

for the FFY 2017 payment adjustment 

year under Medicare. 

Like our proposal to move CAHs to a 

calendar year timeframe, we believe that 

removing the continuous 90-day EHR 

reporting period for most CAHs would 

simplify reporting for providers, 

especially those CAHs with diverse 

groups and systems. In addition, 

eliminating the 90-day EHR reporting 

period would move the EHR Incentive 

Program one step closer to alignment 

within the program and with CMS 

quality reporting programs, and would 

simplify HHS system requirements for 

data capture. Therefore, moving CAHs 

to a calendar year EHR reporting period 

for the payment adjustment year, as well 

as requiring most providers (EPs, CAHs, 

and eligible hospitals) to report based 

on the same full year calendar 

timeframe would accomplish these 

goals and be responsive to prior public 

comments asking us to simplify the EHR 

Incentive Program. 

We welcome public comments on 

these proposals. 

10. Administrative Review Process of 

Certain Electronic Health Record 

Incentive Program Determinations 

In the Stage 2 final rule (77 FR 54112 

through 54113), we discussed an 

administrative appeals process for both 

Stages 1 and 2 of meaningful use. We 

believe this appeals process is primarily 

procedural and does not need to be 

specified in regulation. We have 

developed guidance on the appeals 

process, which is available on our Web 

site at www.cms.gov/

EHRIncentivePrograms. We propose no 

changes in this proposed rule and 

intend to continue to specify the 

appeals process in guidance available 

on our Web site. 

E. Medicare Advantage Organization 

Incentive Payments 

We are not proposing any changes to 

the existing policies and regulations for 

Medicare Advantage (MA) 

organizations. Our existing policies and 

regulations include provisions 

concerning the EHR incentive payments 

to qualifying MA organizations and the 

payment adjustments for 2015 and 

subsequent MA payment adjustment 

years. (For more information on MA 

organization incentive payments, we 

refer readers to the final rules for Stages 

1 and 2 (75 FR 44468 through 44482 and 

77 FR 54113 through 54119).) 

F. The Medicaid EHR Incentive Program 

The proposals discussed in sections 

II.F.1. through II.F.3. of this proposed 

rule would be applicable upon the 

effective date of the final rule, not when 

Stage 3 of meaningful use of certified 

EHR technology begins, unless 

otherwise indicated. 

1. EHR Reporting Period for First Year 

of Meaningful Use 

We are proposing amendments to the 

definitions of ‘‘EHR reporting period’’ 

and ‘‘EHR reporting period for a 

payment adjustment year’’ in § 495.4 to 

shift the EHR reporting periods for 

eligible hospitals and CAHs to periods 

that are based on the calendar year, not 

the federal fiscal year, and to establish 

a full calendar year as the EHR reporting 

period or EHR reporting period for a 

payment adjustment year for almost all 

providers beginning in 2017. However, 

we are also proposing a limited 

exception under which Medicaid EPs 

and eligible hospitals demonstrating 

meaningful use for the first time could 

use any continuous 90-day EHR 

reporting period within the calendar 

year. This EHR reporting period for 

Medicaid providers demonstrating 

meaningful use for the first time would 

apply both for purposes of receiving an 

incentive payment in the Medicaid 

program and for purposes of avoiding 

the payment adjustment under the 

Medicare program for the payment 

adjustment year that is two years after 

the calendar year in which the provider 

first demonstrates meaningful use for an 

EHR reporting period. Under this 

proposal, Medicaid EPs and eligible 

hospitals would have an EHR reporting 

period of any continuous 90-day period 

in the calendar year that is the payment 

year, for their first payment year based 

on meaningful use, beginning in 2017. 

We note that hospitals that are eligible 

under both the Medicaid and Medicare 

incentive programs, and that are 

attesting for the Medicaid program, do 

not need to separately attest in the 

Medicare program in 2017 and 

subsequent years, because the statute 

does not allow for Medicare EHR 

incentive payments to eligible hospitals 

after FY 2016. If a hospital eligible 

under both programs is demonstrating 

meaningful use for the first time, and 

using a continuous 90-day EHR 

reporting period under the Medicaid 

program, it could attest for the Medicaid 

program only, and still avoid the 

Medicare payment adjustment that is 2 

years after the calendar year in which 

the EHR reporting period occurs. 

However, if a hospital eligible under 

both programs chooses also to attest for 

the Medicare program, it would be 

required to complete an EHR reporting 

period of 1 full calendar year to avoid 

the Medicare payment adjustment that 

is 2 years after that calendar year. We 

note that, consistent with the other 

proposed amendments to § 495.4 

discussed previously, this proposal 

would change the EHR reporting period 

for eligible hospitals from one that is 

based on the federal fiscal year to one 

that is based on the calendar year, 

beginning in 2017. For further 

discussion of the relationship between 

the 90-day EHR reporting period under 

the Medicaid EHR Incentive Program 

and the payment adjustments under 

Medicare, we refer readers to section 

II.D. of this proposed rule. 

This policy would allow Medicaid 

providers flexibility in their first year of 

demonstrating meaningful use. It also 

would reduce the burden on states to 

implement significant policy and 

system changes in preparation for Stage 

3, as the 90-day period for the first year 

of meaningful use is consistent with our 

previous policies and meaningful use 

timelines. 

2. Reporting Requirements 

a. State Reporting on Program Activities 

As discussed in section 

II.A.1.c.(1).(b).(iii). of this proposed rule, 

we are adding a new provision at 

§ 495.316(d)(2)(iii) to provide states 

with flexibility regarding the Stage 3 

public health and clinical data registry 

reporting objective. 

We also propose to amend 

§ 495.316(c), as well as add a new 

paragraph § 495.316(f), to formalize the 

process of how states report to us 

annually on the providers that have 

attested to adopt, implement, or upgrade 

(AIU), or that have attested to 

meaningful use. Under this proposal, 

states would follow a structured 

submission process, in the manner 

prescribed by CMS, which would 

include a new annual reporting 

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deadline. We propose to require states 

to submit annual reports to CMS within 

45 days of the end of the second quarter 

of each federal fiscal year. 

We propose to regularize the timing of 

the annual reporting process described 

in § 495.316 to ensure more timely 

annual reports and allow for clearer 

communication to states on when the 

reports should be submitted to CMS. In 

addition, CMS and states would be able 

to more effectively track the progress of 

states’ incentive program 

implementation and oversight as well as 

provider progress in achieving 

meaningful use. Predictable deadlines 

for annual reporting would permit CMS 

and the states to more quickly compare 

and assess overall program impact each 

year. 

We are also considering changes to 

the data that the annual reporting 

requirements outlined in § 495.316(d) 

require states to include in their annual 

reports. Specifically, we are considering 

whether to remove the requirement that 

states report information about practice 

location for providers that qualify for 

incentive payments on the basis of 

having adopted, implemented, or 

upgraded certified EHR technology or 

on the basis of demonstrating they are 

meaningful users of certified EHR 

technology. While we believe that this 

data is useful to both CMS and the states 

for program implementation purposes, 

we believe the benefits of including it in 

state reports might be outweighed by the 

burdens to states of reporting it. 

Therefore, we are seeking more 

information on state burdens and costs 

associated with complying with this 

requirement. We solicit comments both 

on the burdens associated with the 

requirement to report practice location 

information for providers that receive 

incentive payments through the 

Medicaid EHR Incentive Program, and 

on the benefits of including this 

information in state reports. 

We propose to amend § 495.352 to 

formalize the process of how states 

submit quarterly progress reports on 

implementation and oversight activities 

and to specify the elements that should 

be included in the quarterly reports. 

Under this proposal, states would 

follow a structured submission process, 

in the manner prescribed by CMS. We 

propose that states would report on the 

following activities: State system 

implementation dates; provider 

outreach; auditing; state-specific SMHP 

tasks; state staffing levels and changes; 

the number and type of providers that 

qualified for an incentive payment on 

the basis of demonstrating that they are 

meaningful EHR users of certified EHR 

technology and the amounts of 

incentive payments; and the number 

and type of providers that qualified for 

an incentive payment on the basis of 

having adopted, implemented, or 

upgraded certified EHR technology and 

the amounts of incentive payments. 

We propose these changes to the 

quarterly reporting process described in 

§ 495.352 so that CMS and states can 

better track state implementation and 

oversight activity progress in a way that 

would permit CMS and the states to 

compare overall programmatic and 

provider progress. We also expect that 

streamlined and enhanced quarterly 

progress reporting would lead to an 

improvement in overall data quality that 

would help inform future meaningful 

use activity across states. 

We would like to include a deadline 

for states’ quarterly reporting under the 

proposed amendments to § 495.352, and 

are considering requiring states to 

submit quarterly progress reports to 

CMS within 30 days after the end of 

each federal fiscal year quarter. We 

believe that a set deadline would 

improve timeliness and communication, 

but we do not want to set a deadline 

that is overly burdensome for a report 

that must be submitted quarterly. We 

seek public comment on the deadline 

we are considering. 

b. State Reporting on Meaningful EHR 

Users 

Starting in FY 2015 for eligible 

hospitals and CY 2015 for EPs, 

providers that fail to demonstrate 

meaningful use for an applicable EHR 

reporting period will be subject to 

downward payment adjustments under 

Medicare. As discussed in the Stage 2 

final rule (77 FR 54094), EPs who are 

meaningful EHR users under the 

Medicaid EHR Incentive Program for an 

applicable EHR reporting period will be 

considered meaningful EHR users for 

that period for purposes of avoiding the 

Medicare payment adjustments. 

Currently, hospitals eligible for both 

Medicaid and Medicare incentive 

payments attest in both the Medicare 

and Medicaid systems to earn an 

incentive payment in both programs. 

The statute does not authorize Medicare 

EHR incentive payments to eligible 

hospitals after FY 2016. To avoid 

duplicative reporting, hospitals eligible 

under both programs will not be 

required to attest in both programs 

beginning in 2017. Therefore, we must 

have accurate and timely data from 

states regarding both EPs and eligible 

hospitals that have successfully 

demonstrated meaningful use for each 

payment year to ensure that meaningful 

EHR users in the Medicaid EHR 

Incentive Program are appropriately 

exempted from the Medicare payment 

adjustment for the applicable payment 

adjustment year. This additional 

reporting is necessary because the 

electronic data currently contained in 

the National Level Repository are 

insufficient to determine which 

Medicaid providers should be exempted 

from the Medicare payment adjustments 

in an accurate and timely manner. 

Accordingly, we propose to add new 

paragraphs (g) and (h) to § 495.316 to 

require that states submit reports on a 

quarterly basis that identify certain 

providers that attested to meaningful 

use through the Medicaid EHR Incentive 

Program for each payment year. Under 

this proposal, states would submit 

quarterly reports for Medicaid EPs and 

eligible hospitals that successfully attest 

to meaningful use for each payment 

year. 

We propose that states would report 

quarterly, in the manner prescribed by 

CMS, information on each provider that 

successfully attests to meaningful use, 

regardless of whether the provider has 

been paid yet. The report would be 

required to specify the Medicaid state 

and payment year. For each EP or 

eligible hospital listed in the report, the 

state would also specify the Payment 

Year Number, the NPI for EPs and the 

CCN for eligible hospitals, the 

Attestation Submission Date, the State 

Qualification (as either meaningful use 

or blank), and the State Qualification 

Date (the beginning date of the reporting 

period in which successful meaningful 

use attestation was achieved by the EP 

or eligible hospital). The EP or eligible 

hospital’s ‘‘payment year number’’ 

refers to the number of years that the 

provider has been paid in the EHR 

Incentive Program; so, for example, this 

would be ‘‘2’’ for the 2014 payment year 

if the provider received payments for 

2013 and 2014. States would have this 

data, even for providers that have 

previously received an incentive 

payment through the Medicare EHR 

Incentive Program. If the state is 

reporting a disqualification, then the 

state would leave the State Qualification 

field blank. If applicable, in the cases of 

EPs or eligible hospitals previously 

identified as meaningful EHR users, the 

state would be required to specify the 

State Disqualification and State 

Disqualification Date (that is, the 

beginning date of the EHR reporting 

period during which an EP or eligible 

hospital was found not to meet the 

definition of a meaningful EHR user). 

Under this proposal, states would 

submit this information beginning with 

payment year 2013 data. The reports 

would cover back to the 2013 payment 

year because that would be the EHR 

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reporting period for the 2015 Medicare 

payment adjustment year under § 495.4. 

Providers that successfully attested to 

meaningful use for 2013 would be 

exempt from the Medicare payment 

adjustment in 2015. 

Under this proposal, states would not 

be required to include information 

about certain providers in their reports. 

We recognize that several provider types 

that are eligible for the Medicaid EHR 

Incentive Program are not subject to the 

Medicare payment adjustments. 

Accordingly, states would not be 

required to report on those EPs who are 

eligible for the Medicaid EHR Incentive 

Program on the basis of being a nurse 

practitioner, certified nurse-midwife, or 

physician assistant. 

3. Clinical Quality Measurement for the 

Medicaid Program 

States are, and will continue in Stage 

3 to be, responsible for determining 

whether and how electronic reporting of 

CQMs would occur, or whether they 

wish to allow reporting through 

attestation. This is consistent with our 

policy in the Stage 2 final rule (77 FR 

54075). If a state does require 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 Stages 1 and 2 

clinical quality measures electronically 

would be similar for reporting in 2017 

and subsequent years. However, we note 

that subject to our prior approval, this 

is within the states’ purview. States that 

wish to establish the method and 

requirements for electronically reporting 

would continue to be required to do so 

through the SMHP submission, subject 

to our prior approval. 

To further our goals of alignment and 

avoiding duplicative reporting across 

quality reporting programs, we would 

recommend that states include a 

narrative in their SMHP for CY 2017 

describing how their proposed 

meaningful use CQM data submission 

strategy aligns with their State Medicaid 

Quality Strategy and report which 

certified EHR technology requirements 

they mandate for eCQM reporting. 

For more information on requirements 

around the State Medicaid Quality 

Strategy, see http://medicaid.gov/

Federal-Policy-Guidance/Downloads/

SHO-13-007.pdf. 

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 evaluate fairly 

whether an information collection 

should be approved by OMB, section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires that we 

solicit comment on the following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

The following is a discussion of the 

requirements contained in this proposed 

regulation that we believe are subject to 

PRA and collection of information 

requirements (ICRs). 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.C. of 

this proposed rule. The actual burden 

would remain constant for all of Stage 

3 as EPs, eligible hospitals, and CAHs 

would only need to attest that they have 

successfully demonstrated meaningful 

use in 2017 and annually thereafter. The 

only variable from year-to-year in Stage 

3 would be the number of respondents, 

as noted in the impact analysis 

assumptions. For the purposes of this 

analysis, we are focusing only on 2017, 

the first year in which a provider may 

participate in Stage 3 of the Medicare 

EHR Incentive Program. We do not 

believe the burden for EPs, eligible 

hospitals, and CAHs participating in 

Stages 1 and 2 prior to 2017 would 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 report their clinical 

quality measures through the respective 

electronic reporting pilots. For eligible 

hospitals and CAHs, the burden is 

discussed in the CY 2012 Hospital 

Outpatient Prospective Payment System 

final rule with comment period (76 FR 

73450 through 73451). 

As discussed in section I.A.1.a. of this 

proposed rule, Stage 3 is intended to 

build on Stages 1 and 2 with a focus on 

advanced use of certified EHR 

technology to promote improved patient 

outcomes while assuring that the 

framework is flexible and does not 

hinder innovation. In this proposed 

rule, the definition of meaningful use 

with associated reporting requirements 

would replace all prior definitions and 

requirements beginning in 2018. At that 

point, all eligible providers would be 

required to report only Stage 3 

requirements on an annual basis. For 

2017, providers may simply repeat their 

current status at Stage 1 or Stage 2, or 

move on to Stage 3. The same reporting 

time would apply to all providers. 

Consequently, the proposed ICRs reflect 

the provider burden associated with 

complying with and reporting of Stage 

3 requirements beginning in 2017 and 

each subsequent year. 

We are soliciting public comment on 

each of these issues for the following 

sections of this document that contain 

information collection requirements 

(ICRs). 

A. ICR Regarding Demonstration of 

Meaningful Use Criteria (§ 495.6, § 495.7 

and § 495.8) 

In § 495.7 we propose that to 

successfully demonstrate meaningful 

use of certified EHR technology for 

Stage 3, 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— 

• The provider used certified EHR 

technology and specified the technology 

was used; and 

• The provider satisfied each of the 

applicable objectives and associated 

measures in § 495.7. 

In § 495.8, we stipulate 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 

captures many of the objectives and 

associated measures and generate 

automated numerator and denominator 

information where required, or generate 

automated summary reports. We also 

expect that the provider would enable 

the functionality required to complete 

the objectives and associated measures 

that require the provider to attest that 

they have done so. 

We propose that there would be 5 

objectives and 10 measures that would 

require an EP to enter numerators and 

denominators during attestation. 

Eligible hospitals and CAHs would have 

to attest they have met 5 objectives and 

10 measures that would require 

numerators and denominators. For 

objectives and associated measures 

requiring a numerator and denominator 

in this proposed rule, we limit our 

estimates to actions taken in the 

presence of certified EHR technology. 

We do not anticipate a provider would 

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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 

designee approximately 10 minutes to 

attest to each meaningful use objective 

and associated measure that requires a 

numerator and denominator to be 

generated. The security risk assessment 

and its associated measure would not 

require a numerator and denominator 

and we would expect it would take an 

individual provider or designee 

approximately 6 hours to complete. The 

clinical decision support and active 

engagement with a public health agency 

measures would take an eligible 

professional, eligible hospital or critical 

access hospital 1 minute each to report 

each CDS intervention or registry. 

We propose that EPs would be 

required to report on a total of 8 

objectives and 16 associated measures. 

For the purpose of this proposed 

collection of information, we assumed 

that all eligible providers would comply 

with the requirements of meaningful use 

Stage 3. We propose that eligible 

hospitals and CAHs would be required 

to report on a total of 8 objectives and 

17 associated measures. We estimated 

the total annual cost burden for all 

eligible hospitals and CAHs to attest to 

EHR technology, meaningful use 

objectives and associated measures, and 

electronically submit the clinical quality 

measures would be $2,135,204 (4,900 

eligible hospitals and CAHs × 6 hours 

52 minutes × $63.46 (mean hourly rate 

for lawyers based on May 2013 BLS) 

data)). We estimate the total annual cost 

burden for all EPs to attest to EHR 

technology, meaningful use objectives 

and associated measures, and 

electronically submit the clinical quality 

measures would be $385,834,395 

(609,100 EPs × 6 hours 52 minutes × 

$92.25 (mean hourly rate for physicians 

based on May 2013 BLS) data). 

In this proposed rule, there are 5 

objectives that would require an EP to 

enter numerators and denominators 

during attestation. Eligible hospitals and 

CAHs would have to attest that they 

have met five 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 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 would be 

required to report they have completed 

objectives and associated measures that 

require a ‘‘yes’’ or ‘‘no’’ response during 

attestation. For EPs, there are three 

objectives that would require a ‘‘yes’’ or 

‘‘no’’ response during attestation. As 

discussed previously, the associated 

measures are that EPs are required to 

conduct a security risk analysis, report 

to three registries to fulfil the public 

health objective, and must implement at 

least five clinical decision support 

interventions. For eligible hospitals and 

CAHs, there are three objectives that 

would require a ‘‘yes’’ or ‘‘no’’ response 

during attestation. The associated 

measures for eligible hospitals and 

CAHs require the provider to conduct a 

security risk analysis, report to four 

registries to fulfill the public health 

objective and must implement at least 

five clinical decision support 

interventions. We estimate each of these 

measures would take 1 minute to report. 

Providers would also be required to 

attest that they are protecting electronic 

health information. We estimate 

completion of the analysis required to 

meet successfully the associated 

measure for this objective would take 

approximately 6 hours, which is 

identical to our estimate for the Stage 1 

and Stage 2 requirements. 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 6 lists those objectives and 

associated measures for EPs and eligible 

hospitals and CAHs. We estimate the 

objectives and associated measures 

would take an EP 6 hours 52 minutes to 

complete, and would take an eligible 

hospital or CAH 6 hours 52 minutes to 

complete. 

In this proposed rule EPs, eligible 

hospitals, and CAHs have virtually 

identical burdens. Eligible hospitals and 

CAHs are required to report to one 

additional registry than EPs are required 

to report. Consequently, we have not 

prepared lowest and highest burdens. 

Rather, we have computed a burden for 

EPs and a burden for eligible hospitals 

and CAHs. 

TABLE 6—BURDEN ESTIMATES

Objectives—Eligible professionals Objectives—Eligible hospitals/CAHs Measures 

Burden estimate 

per respondent 

(EPs) 

Burden estimate 

per respondent 

(hospitals) 

Protect electronic protected health information (ePHI) created or maintained 

by the CEHRT through the implementation of appropriate technical, administrative and physical safeguards.

Protect electronic protected health information (ePHI) created or maintained 

by the CEHRT through the implementation of appropriate technical, administrative and physical safeguards.

Conduct or review a security risk analysis in accordance with the requirements under 45 CFR 164.308(a)(1), 

including addressing the security (to 

include encryption) of data stored in 

CEHRT in accordance with requirements under 45 CFR 164.312(a)(2)(iv) 

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

security updates as necessary, and 

correct identified security deficiencies 

as part of the provider’s risk management process.

6 hours ............. 6 hours. 

Generate and transmit permissible prescriptions electronically (eRx.).Generate and transmit permissible discharge prescriptions electronically 

(eRx).

1. EP Measure: More than 80% of all 

permissible prescriptions written by 

the EP are queried for a drug formulary and transmitted electronically 

using CEHRT.

10 minutes ........ 10 minutes. 

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TABLE 6—BURDEN ESTIMATES—Continued 

Objectives—Eligible professionals Objectives—Eligible hospitals/CAHs Measures 

Burden estimate 

per respondent 

(EPs) 

Burden estimate 

per respondent 

(hospitals) 

............................................................. 2. Eligible Hospital Measure: More than 

25% of hospital discharge medication 

orders for permissible prescriptions 

(for new and changed prescriptions) 

are queried for a drug formulary and 

transmitted electronically using 

CEHRT. 

Implement clinical decision support 

(CDS) interventions focused on improving performance on high-priority 

health conditions.

Implement clinical decision support 

(CDS) interventions focused on improving performance on high-priority 

health conditions.

Measure 1: The EP, eligible hospital and 

CAH must implement five clinical decision support interventions related to 

four or more CQMs at a relevant point 

in patient care for the entire EHR reporting period. Absent four CQMs related to an EP, eligible hospital, or 

CAH’s scope of practice or patient 

population, the clinical decision support interventions must be related to 

high-priority health conditions.

1 minute ............ 1 minute. 

............................................................. Measure 2: The EP, eligible hospital, or 

CAH has enabled and implemented 

the functionality for drug-drug and 

drug-allergy interaction checks for the 

entire EHR reporting period. 

Use computerized provider order entry 

(CPOE) for medication, laboratory, 

and diagnostic imaging orders directly 

entered by any licensed healthcare 

professional, credentialed medical 

assistant, or a medical staff member 

credentialed to and performing the 

equivalent duties of a credentialed 

medical assistant; who can enter orders into the medical record per state, 

local, and professional guidelines.

Use computerized provider order entry 

(CPOE) for medication, laboratory, 

and diagnostic imaging orders directly 

entered by any licensed healthcare 

professional, credentialed medical assistant, or a medical staff member 

credentialed to and performing the 

equivalent duties of a credentialed 

medical assistant; who can enter orders into the medical record per state, 

local, and professional guidelines.

Measure 1: More than 80 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 computerized provider 

order entry..

10 minutes ........ 10 minutes. 

............................................................. Measure 2: More than 60 percent of laboratory orders created by the EP or 

authorized providers of the eligible 

hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) 

during the EHR reporting period are 

recorded using computerized provider 

order entry 

............................................................. Measure 3: More than 60 percent of 

diagnostic imaging 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 computerized provider order entry. 

The EP provides access for patients to 

view online, download, and transmit 

their health information, or retrieve 

their health information through an 

API, within 24 hours of its availability.

The eligible hospital or CAH provides 

access for patients to view online, 

download, and transmit their health information, or retrieve their health information through an API, within 24 

hours of its availability.

Measure 1: For more than 80 percent of 

all unique patients seen by the EP or 

discharged from the eligible hospital 

or CAH inpatient or emergency department (POS 21 or 23): 

10 minutes ........ 10 minutes. 

............................................................. (1) The patient (or the patient authorized 

representative) is provided access to 

view online, download, and transmit 

his or her health information within 24 

hours of its availability to the provider; 

or 

............................................................. (2) The patient (or the patient authorized 

representative) is provided access to 

an ONC-certified API that can be used 

by third-party applications or devices 

to provide patients (or patient authorized representatives) access to their 

health information, within 24 hours of 

its availability to the provider 

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TABLE 6—BURDEN ESTIMATES—Continued 

Objectives—Eligible professionals Objectives—Eligible hospitals/CAHs Measures 

Burden estimate 

per respondent 

(EPs) 

Burden estimate 

per respondent 

(hospitals) 

............................................................. Measure 2: The EP, eligible hospital or 

CAH must use clinically relevant information from CEHRT to identify patient-specific educational resources 

and provide electronic access to those 

materials to more than 35 percent of 

unique patients seen by the EP or discharged from the eligible hospital or 

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

reporting period. 

Use communications functions of certified EHR technology to engage with 

patients or their authorized representatives about the patient’s care.

Use communications functions of certified EHR technology to engage with 

patients or their authorized representatives about the patient’s care 

Measure 1: During the EHR reporting 

period, more than 25 percent of all 

unique patients seen by the EP or discharged from the eligible hospital or 

CAH inpatient or emergency department (POS 21 or 23) actively engage 

with the electronic health record made 

accessible by the provider. An EP 

may meet the measure by either—.

10 minutes ........ 10 minutes. 

............................................................. (1) More than 25 percent of all unique 

patients (or patient-authorized representatives) seen by the EP or discharged from the eligible hospital or 

CAH during the EHR reporting period 

view, download or transmit to a third 

party their health information; or 

............................................................. (2) More than 25 percent of all unique 

patients (or patient-authorized representatives) seen by the EP or discharged from the eligible hospital or 

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

reporting period access their health information through the use of an ONCcertified API that can be used by thirdparty applications or devices. 

............................................................. Measure 2: During the EHR reporting 

period, for more than 35 percent of all 

unique patients seen by the EP or discharged from the eligible hospital or 

CAH during the EHR reporting period, 

a secure message was sent using the 

electronic messaging function of 

CEHRT to the patient (or their authorized representatives), or in response 

to a secure message sent by the patient. 

............................................................. Measure 3: Patient-generated health 

data or data from a non-clinical setting 

is incorporated into the certified EHR 

technology for more than 15 percent 

of all unique patients seen by the EP 

or discharged by the eligible hospital 

or CAH during the EHR reporting period. 

The EP provides a summary of care 

record when transitioning or referring 

their patient to another setting of care, 

retrieves a summary of care record 

upon the first patient encounter with a 

new patient, and incorporates summary of care information from other 

providers into their EHR using the 

functions of certified EHR technology.

The eligible hospital or CAH provides a 

summary of care record when 

transitioning or referring their patient 

to another setting of care, retrieves a 

summary of care record upon the first 

patient encounter with a new patient, 

and incorporates summary of care information from other providers into 

their EHR using the functions of certified EHR technology.

Measure 1: For more than 50 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—(1) creates a summary of care 

record using CEHRT; and (2) electronically exchanges the summary of 

care record.

10 minutes ........ 10 minutes. 

............................................................. Measure 2: For more than 40 percent of 

transitions or referrals received and 

patient encounters in which the provider has never before encountered 

the patient, the EP, eligible hospital or 

CAH incorporates into the patient’s 

record in their EHR an electronic summary of care document from a source 

other than the provider’s EHR system. 

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TABLE 6—BURDEN ESTIMATES—Continued 

Objectives—Eligible professionals Objectives—Eligible hospitals/CAHs Measures 

Burden estimate 

per respondent 

(EPs) 

Burden estimate 

per respondent 

(hospitals) 

............................................................. Measure 3: For more than 80 percent of 

transitions or referrals received and 

patient encounters in which the provider has never before encountered 

the patient, the EP, eligible hospital, 

or CAH performs clinical information 

reconciliation. The provider would 

choose at least two of the following 

three clinical information sets on 

which to perform reconciliations: 

............................................................. Medication. Review of the patient’s 

medication, including the name, dosage, frequency, and route of each 

medication. 

............................................................. Medication allergy. Review of the patient’s known allergic medications. 

............................................................. Current Problem list. Review of the patient’s current and active diagnoses. 

The EP is in active engagement with a 

PHA or CDR to submit electronic public health data in a meaningful way 

using certified EHR technology, except 

where prohibited, and in accordance 

with applicable law and practice.

The eligible hospital or CAH is in active 

engagement with a PHA or CDR to 

submit electronic public health data in 

a meaningful way using certified EHR 

technology, except where prohibited, 

and in accordance with applicable law 

and practice.

Providers must report data on an ongoing basis to established public health 

registries. 

1 minute ............ 1 minute. 

............................................................. Measure 1: Immunization Registry Reporting: The EP, eligible hospital, or 

CAH is in active engagement with a 

public health agency to submit immunization data and receive immunization forecasts and histories from the 

public health immunization registry/immunization information system (IIS). 

............................................................. Measure 2: Syndromic Surveillance Reporting: The EP, eligible hospital, or 

CAH is in active engagement with a 

public health agency to submit 

syndromic surveillance data from a 

non-urgent care ambulatory setting for 

EPs, or an emergency or urgent care 

department for eligible hospitals and 

CAHs (POS 23). 

............................................................. Measure 3: Case Reporting: The EP, eligible hospital, or CAH is in active engagement with a public health agency 

to submit case reporting of reportable 

conditions. 

............................................................. Measure 4: Public Health Registry Reporting: The EP, eligible hospital, or 

CAH is in active engagement with a 

public health agency to submit data to 

public health registries.

............................................................. Measure 5: Clinical Data Registry Reporting: The EP, eligible hospital, or 

CAH is in active engagement to submit data to a clinical data registry. 

............................................................. Measure 6: Electronic Reportable Laboratory Result Reporting: The eligible 

hospital or CAH is in active engagement with a public health agency to 

submit electronic reportable laboratory 

results 

............................................................. EP Objective: report to 3 of the following 

registries: 

Immunization 

Syndromic Surveillance 

Case Reporting 

Public Health 

Clinical Data 

............................................................. EPs may choose to report to more than 

one public health registry to meet the 

number of measures required to meet 

the objective. 

............................................................. EPs may choose to report to more than 

one clinical data registry to meet the 

number of measures required to meet 

the objective. 

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16786 Federal Register / Vol. 80, No. 60 / Monday, March 30, 2015 / Proposed Rules 

TABLE 6—BURDEN ESTIMATES—Continued 

Objectives—Eligible professionals Objectives—Eligible hospitals/CAHs Measures 

Burden estimate 

per respondent 

(EPs) 

Burden estimate 

per respondent 

(hospitals) 

............................................................. EH/CAH Objective: report to 4 of the following registries: 

Immunization 

Syndromic Surveillance 

Case Reporting 

Public Health 

Clinical Data 

Electronic Reportable Laboratory 

Results. 

............................................................. Eligible hospitals and CAHs may choose 

to report to more than one public 

health registry to meet the number of 

measures required to meet the objective. 

............................................................. Eligible hospitals and CAHs may choose 

to report to more than one clinical 

data registry to meet the number of 

measures required to meet the objective. 

Criteria Burden Time to Attest and 

Report Clinical Quality Measures.

.................................................................. .................................................................. 6 hours 52 minutes.6 hours 52 minutes. 

Total—Criteria Burden .............. .................................................................. .................................................................. 6 hours 52 minutes.6 hours 52 minutes. 

In this proposed rule, we estimate that 

it would take no longer than 6 hours 

and 52 minutes for an EP to satisfy each 

of the applicable objectives and 

associated measures. The total burden 

hours for an EP to attest to the criteria 

previously specified would be 6 hours 

52 minutes. We estimate that there 

could be approximately 609,100 nonhospital-based Medicare and Medicaid 

EPs in 2017. 

We estimate the burden for the 

approximately 13,635 MA EPs in the 

MAO burden section. We estimate the 

total burden associated with these 

requirements for an EP would be 6 

hours 52 minutes. The total estimated 

annual cost burden for all EPs to attest 

to EHR technology and meaningful use 

objectives would be $385,834,395 

(506,400 × 6 hours 52 minutes × $92.25 

(mean hourly rate for physicians based 

on May 2013 BLS data)). 

Similarly, eligible hospitals and CAHs 

would attest that they have met the core 

meaningful use objectives and 

associated measures, and would 

electronically submit the clinical quality 

measures. We estimate that it would 

take no longer, than 6 hours and 52 

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 objectives and associated 

measures. We estimate that there are 

about 4,900 eligible hospitals and CAHs 

(3,397 acute care hospitals, 1,395 CAHs, 

97 children’s hospitals, and 11 cancer 

hospitals) that may attest to the 

aforementioned criteria in FY 2017. We 

estimate the total burden associated 

with these requirements for an eligible 

hospital and CAH would be 6 hours 52 

minutes. The total estimated annual cost 

burden for all eligible hospitals and 

CAHs to attest to EHR technology, 

meaningful use core set and menu set 

criteria, and electronically submit the 

clinical quality measures would be 

$2,135,204 (4,908 eligible hospitals and 

CAHs × $63.46 (6 hours 52 minutes × 

$63.46 (mean hourly rate for lawyers 

based on May 2013 BLS) data)). 

B. ICRs Regarding Qualifying MA 

Organizations (§ 495.210) 

In this proposed rule, we estimate that 

the burden would be significantly less 

for qualifying MA organizations 

attesting to the meaningful use of their 

MA EPs in Stage 3, because 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 would 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 together 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 would 

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 would not likely be 

eligible professional, but non-clinical 

staff. We believe that the individual 

gathering the information could be 

equivalent to a GS 11, step 1 (2015 

unadjusted for locality rate), 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 

(2015 unadjusted for locality rate), or 

approximately $50.00/hour. Therefore, 

for the estimated 13,635 potentially 

qualifying MA EPs, we believe it would 

cost the participating qualifying MA 

organizations approximately $426,050 

annually to make the attestations 

([10,226 hours × $25.00] + [3,408 hours 

× $50.00]). 

C. ICR Regarding State Reporting 

Requirements (§ 495.316 and § 495.352) 

We are proposing to revise 42 CFR 

495 regarding state reporting 

requirements to CMS. With respect to 

the annual reporting requirements in 

§ 495.316 and the quarterly reporting 

requirements in § 495.352, we do not 

believe that the proposed amendments 

to these reporting requirements would 

increase the burden on states beyond 

what was previously finalized under 

OMB control number 0938–1158 

following the Stage 2 final rule. The 

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deadlines we propose or are considering 

would be consistent with our past 

practice, and the changes we propose or 

consider to the data elements to be 

reported on would be either reduced or 

similar in burden. Similarly, we do not 

expect the proposed amendments 

regarding the 90-day EHR reporting 

period for first time meaningful users 

would impose a burden on states 

because those amendments would 

generally maintain the current policy. 

However, we are proposing to revise 

§ 495.316 to include a new quarterly 

reporting requirement. Under the 

proposed amendment, states would 

report quarterly to CMS regarding the 

EPs and Medicaid eligible hospitals that 

have successfully demonstrated 

meaningful use for each payment year. 

We need this information to ensure that 

those EPs who are meaningful EHR 

users in the Medicaid EHR Incentive 

Program are appropriately exempted 

from the Medicare payment adjustment. 

We cannot accurately exempt these 

providers using the current data 

received from states. We expect that it 

would take a state 20 hours each year 

to submit this report on a quarterly 

basis. We believe that the state 

employee reporting the information 

could be equivalent to a GS 12, step 1 

(2015 unadjusted for locality rate), with 

an hourly rate of approximately $30.00/ 

hour. This amount is then reduced by 

the 90 percent federal contribution for 

administrative services for Medicaid 

under the EHR Incentive Programs, this 

equates to approximately $3.00/hour. 

Therefore, for all state Medicaid 

agencies to report four times per year at 

20 hours per report the estimated cost 

is $13,460 (4560 hours × $3.00/hour). 

TABLE 7—ESTIMATED ANNUAL INFORMATION COLLECTION BURDEN

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.x—Objectives/

Measures (EPs) ........ 0938–1158 609,100 609,100 6.86 4,178,426 92.25 385,834,395 

§ 495.6—Objectives/

Measures (hospitals/

CAHs) ....................... 0938–1158 4,900 4,900 6.86 33,614 63.46 2,135,204 

§ 495.210—Gather information for attestation (MA EPs) ........... 0938–1158 13,635 13,635 0.75 10,226 25.00 255,650 

§ 495.210—Attestation 

on behalf of MA EPs 0938–1158 13,635 13,635 0.25 3408.75 50.00 170,400 

§ 495.316—Quarterly 

Reporting .................. 0938–1158 56 224 20 4480 3.00 13,440 

Totals .................... ........................ 627,635 627,635 ........................ 4,225,674 ........................ 388,408,189 

Notes: 

All non-whole numbers in this table are rounded to 2 decimal places. 

There are no capital/maintenance costs associated with the information collection requirements contained in this rule. Therefore, we have removed the associated column from Table 7. 

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 final rule; or 

2. Submit your comments to the 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Attention: CMS Desk Officer, 

[CMS–3310–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 proposed rule, 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. This proposed rule 

specifies applicable criteria for 

demonstrating Stage 3 of meaningful 

use. 

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 (RIA) that 

presents the estimated costs and 

benefits of this proposed rule. 

As noted in section I.A.2. of this 

proposed rule, this proposed rule is one 

of two coordinated rules related to the 

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13 In this case, the provider implementation and 

adoption costs discussed in this CMS RIA would 

instead be attributable to ONC’s rulemaking. 

meaningful use of certified EHR 

technology. The other is ONC’s 2015 

Edition Health Information Technology 

(Health IT) Certification Criteria, 2015 

Edition Base Electronic Health Record 

(EHR) Definition, and ONC Health IT 

Certification Program Modifications 

proposed elsewhere in this issue of the 

Federal Register. This analysis focuses 

on the impact associated with Stage 3 

requirements for meaningful use, the 

changes in quality measures that would 

take effect beginning in 2017, and other 

changes being proposed for the 

Medicare and Medicaid EHR Incentive 

Programs. 

As we discussed in the Stage 2 final 

rule (77 FR 54163 through 54291), a 

number of factors would affect the 

adoption of EHR systems and 

demonstration of meaningful use. In this 

proposed rule, we continue to believe 

that a number of factors would affect the 

adoption of EHR systems and 

demonstration of meaningful use. 

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 2017 

and for eligible hospitals and EPs, but 

on future rulemakings issued by the 

HHS. 

We further stated in the 2012 Stage 2 

final rule (77 FR 54135 through 54136), 

the statute 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. Beginning 

in 2015, payment adjustments are 

incorporated into the Medicare EHR 

Incentive 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. 

An uncertainty arises because under 

current law, physicians are scheduled 

for a large payment reduction in April 

2015 under the sustainable growth rate 

(SGR) formula, which determines 

Medicare physician payment updates. A 

large payment reduction could cause 

major changes in physician behavior, 

enrollee care, and other Medicare 

provider payments, but the specific 

nature of these changes is uncertain. 

Under current law, the remaining EHR 

incentives for Medicaid or the Medicaid 

payment adjustments will exert only a 

minor influence on physician behavior 

relative to this large physician payment 

reduction. However, the Congress has 

legislatively avoided a large physician 

payment reduction for each year since 

2002. 

All of these factors taken together 

make it impossible in this proposed rule 

to predict with precision the timing or 

rates of adoption and meaningful use. 

However, new data is currently 

available regarding rates of adoption or 

costs of implementation since the 

publication of our Stage 1 and Stage 2 

final rules. We have included the new 

data in our estimates, although even 

these forecasts are still fairly uncertain. 

Overall, in this proposed rule, we 

expect spending under the EHR 

incentive program for transfer payments 

to Medicare and Medicaid providers 

between 2017 and 2020 to be $3.7 

billion (this estimate includes net 

payment adjustments for Medicare 

providers who do not achieve 

meaningful use in the amount of $0.8 

billion). We have also estimated ‘‘per 

entity’’ costs for EPs, eligible hospitals, 

and CAHs for implementation/

maintenance and reporting requirement 

costs, not all costs. We believe many 

adopting entities may achieve dollar 

savings at least equal to their total costs, 

and that there may be additional 

benefits to society. We also believe that 

implementation costs are significant for 

each participating entity because 

providers who were like to qualify as 

meaningful users of EHRs were likely to 

purchase certified EHR technology. 

However, we believe that providers who 

have already purchased certified EHR 

technology and participated in Stage 1 

or Stage 2 of meaningful use will 

experience significantly lower costs for 

participation in the program. We 

continue to believe that the short-term 

costs to demonstrate meaningful use of 

certified EHR technology may be 

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 presents the 

estimated costs and benefits of this 

proposed rule. 

C. Anticipated Effects 

The objective of the remainder of this 

proposed 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 

health care industry for implementation 

of this technology. 

1. Overall Effects 

a. EHR Technology Development and 

Certification Costs 

We note that the costs incurred by IT 

developers for EHR technology 

development and certification to the 

2015 Edition certification criteria for 

health IT are also in part attributable to 

the requirements for the use of CEHRT 

established in this proposed rule for 

Stage 3 of the EHR Incentive Programs. 

Therefore, to the extent that providers’ 

implementation and adoption costs are 

attributable to this proposed rule, health 

IT developers’ preparation and 

development costs would also be 

attributable as these categories of 

activities may be directly or indirectly 

incentivized by the requirements to 

demonstrate meaningful use. However, 

even if this Stage 3 proposed rule were 

not finalized, other CMS programs (for 

example PQRS and IQR) do require or 

promote certification to ONC’s criteria— 

or a professional organization or other 

such entity could require or promote 

certification to ONC’s critieria.13 As 

noted previously, this analysis focuses 

on the impact associated with Stage 3 

requirements for meaningful use for 

providers; while the development and 

certification costs are addressed in the 

the 2015 Edition proposed rule 

published elsewhere in this issues of the 

Federal Register. 

b. 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 health care 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. 

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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 

would be economically significant. 

Accordingly, this RIA section, in 

conjunction with the remainder of the 

preamble, constitutes the required 

Initial Regulatory Flexibility Analysis 

(IRFA). 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 

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 

in 2015. 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 currently 

implemented 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 used 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. 

Data available suggests that more 

providers have adopted EHR technology 

since the publication of the Stage 1 final 

rule. An ONC data brief (No. 16, May 

2014) noted that hospital adoption of 

EHR systems has increased 5 fold since 

2008. Nine in ten acute care hospitals 

possessed CEHRT in 2013, increasing 29 

percent since 2011. In January 2014, a 

Centers for Disease Control and 

Prevention (CDC) data brief entitled, 

‘‘Use and Characteristics of Electronic 

Health Record Systems Among Officebased Physician Practices: United 

States, 2001 through 2013 found that 78 

percent of office-based used any type of 

EHR systems, up from 18 percent in 

2001. The majority of EPs have already 

purchased certified EHR technology, 

implemented this new technology, and 

trained 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 

may compensate for some of the initial 

expenditures. 

(1) Small Entities 

We estimate that EPs would spend 

approximately $54,000 to purchase and 

implement a certified EHR and $10,000 

annually for ongoing maintenance 

according to the Congressional Budget 

Office (CBO) (75 FR 44546). 

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. Annual operating and 

maintenance amount was estimated at 

12 to 20 percent of initial costs (that is, 

$3,000 to $9,000) per physician. For all 

eligible hospitals, the range is from $1 

million to $100 million. Though reports 

vary widely, we anticipate that the 

average will be $5 million for eligible 

hospitals to achieve meaningful use. We 

estimate $1 million for maintenance, 

upgrades, and training each year per 

eligible hospital. However, as stated 

earlier many providers have already 

purchased systems with expenditures 

focused on maintenance and upgrades. 

We believe that future retrospective 

studies on the costs to implement and 

EHR and the return on investment (ROI) 

will demonstrate the actual costs 

incurred by providers participating in 

the EHR Incentive Programs. 

(2) Conclusion 

As discussed later in this analysis, we 

believe that there are many positive 

effects of adopting EHR on health care 

providers. We believe that the net effect 

on some individual providers may be 

positive. Accordingly, we believe that 

the object of the RFA to minimize 

burden on small entities is met by this 

proposed rule. 

b. Small Rural Hospitals 

Section 1102(b) of the Act requires us 

to prepare a regulatory impact analysis 

(RIA) if a rule will have a significant 

impact on the operations of a substantial 

number of small rural hospitals. This 

analysis must conform to the provisions 

of section 603 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, the Secretary retains 

the discretionary statutory authority to 

make case-by-case exceptions for 

significant hardships, and has already 

established certain categories where 

case-by-case applications may be made 

such as barriers to internet connectivity 

that impact health information 

exchange. 

c. Unfunded Mandates Reform Act 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates will require 

spending in any 1 year $100 million in 

1995 dollars, updated annually for 

inflation. In 2014, that threshold is 

approximately $141 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 proposed 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 

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substantial state expense. In general, 

each state Medicaid Agency that 

participates in the incentive program 

would be required to invest in systems 

and technology to comply. States would 

have to identify and educate providers, 

evaluate their attestations and pay the 

incentive. However, the federal 

government would 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 

would 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 

$141 million. However, because EPs 

may choose for various reasons not to 

participate in the program, we do not 

have firm data for the percentage of 

participation within the private sector. 

This RIA, taken together with the 

remainder of the preamble, constitutes 

the analysis required by UMRA. 

d. Federalism 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a final 

rule that imposes substantial direct 

requirement costs on state and local 

governments, preempts state law, or 

otherwise has federalism implications. 

This proposed rule will not have a 

substantial direct effect on state or local 

governments, preempt state law, or 

otherwise have a federalism 

implication. Importantly, state Medicaid 

agencies are receiving 100 percent 

match from the federal government for 

incentives paid and a 90-percent match 

for expenses associated with 

administering the program. As 

previously stated, we believe that state 

administrative costs are minimal. We 

note that this proposed rule does add a 

new business requirement for states, 

because of the existing systems that 

would 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 EPs, 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 

finalized for Stage 1 and Stage 2 and is 

being proposed for Stage 3, but may 

change 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, we 

estimated the numbers of EPs and 

eligible hospitals, including CAHs 

under Medicare, Medicaid, and MA and 

used them throughout the analysis. 

• About 675,500 Medicare FFS EPs in 

2017 (some of whom will also be 

Medicaid EPs). 

• About 60,600 non-Medicare eligible 

EPs (such as dentists, pediatricians, and 

eligible non-physicians such as certified 

nurse-midwives, nurse practitioners, 

and physicians assistants) could be 

eligible to receive the Medicaid 

incentive payments in 2017. 

• 4,900 eligible hospitals comprising 

the following: 

++ 3,397 acute care hospitals 

++ 1,395 CAHs 

++ 97 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. 

• About 16 MA organizations 

b. Industry Costs and Adoption Rates 

In the Stage 2 final rule (77 FR 54136 

through 54146), we estimated the 

impact on health care providers using 

information from four studies. In the 

absence of any more recent estimates 

that we are aware of, in this proposed 

rule, we continue to use the same 

estimates cited in the Stage 2 final rule. 

We continue to believe that these 

estimates are reasonably reflective of 

EHR costs. However, we note, we are 

unable to delineate all costs due to the 

great variability in characteristics among 

the entities that are affected by the 

proposed rule; the variability includes, 

but is not limited to, the size of the 

practice, extent of use of electronic 

systems, type of system used, number of 

staff using the EHR system and the cost 

for maintaining and/or upgrading 

systems. 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, we continue 

to estimate the range is from $1 million 

to $100 million. Although reports vary 

widely, we continue to anticipate that 

the average will be $5 million to achieve 

meaningful use, because providers who 

will like to qualify as meaningful users 

of EHRs will need to purchase certified 

EHRs. We further acknowledge 

‘‘certified EHRs’’ may differ in many 

important respects from the EHRs 

currently in use and may differ in the 

functionalities they contain. We 

continue to 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. However, as noted 

previously, we are unable to delineate 

all costs due to the great variability in 

characteristics among the entities that 

are affected by the proposed rule; the 

variability includes, but is not limited 

to, the size of the hospital, extent of use 

of electronic systems, type of system 

used, number of staff using the EHR 

system and the cost for maintaining 

and/or upgrading systems. 

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 

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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. In the absence of additional 

data regarding the cost of adoption and 

implementation costs for certified EHR 

technology, we proposed to continue to 

estimate for EPs that the average adopt/ 

implement/upgrade cost is $54,000 per 

physician FTE, while annual 

maintenance costs average $10,000 per 

physician FTE, based on the cost 

estimate of the Stage 1 final rule. 

However, as noted previously, we are 

unable to delineate all costs due to the 

great variability that are affected by but 

not limited to the size of the practice, 

extent of use of electronic systems, type 

of system used, number of staff using 

the EHR system, and the cost for 

maintaining and/or upgrading systems. 

d. Costs of EHR Adoption for Eligible 

Hospitals 

According to the American Hospital 

Association 2008 Survey, the range in 

yearly information technology spending 

among hospitals ranged from $36,000 to 

over $32 million. EHR system costs 

specifically were reported by other 

experts to run as high as $20 million to 

$100 million (77 FR 54139). We note 

that recently we have seen about 96 

percent of eligible hospitals have 

received at least one incentive payment 

under either the Medicare or Medicaid 

programs. However, as noted 

previously, we are unable to delineate 

all costs due to the great variability that 

are affected by but not limited to the 

size of the eligible hospital, extent of 

use of electronic systems, type of system 

used, number of staff using the EHR 

system, and the cost for maintaining 

and/or upgrading systems. 

3. Medicare Incentive Program Costs 

The estimates for the HITECH Act 

provisions are based on the economic 

assumptions underlying the President’s 

FY 2016 Budget. Under the statute, 

Medicare incentive payments for 

certified EHR technology are excluded 

from the determination of MA 

capitation benchmarks. We continue to 

expect a negligible impact on benefit 

payments to hospitals and EPs from 

Medicare and Medicaid because of the 

implementation of EHR technology. 

As noted at the beginning of this 

analysis, it is difficult to predict the 

actual impacts of the HITECH Act with 

great 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. 

a. Medicare Eligible Professionals (EPs) 

We began making EHR Incentive 

payments in 2011. Medicare payments 

are to be paid for the successful 

demonstration on meaningful use 

through CY 2016. Due to the payment 

lag, some payments may be issued in CY 

2017. To avoid the Medicare payment 

adjustment beginning in 2015, EPs need 

to successfully demonstrate meaningful 

use regardless of whether they earn an 

incentive payment. We estimated the 

percentage of the remaining EPs who 

would be meaningful users each 

calendar year. Table 8 shows the results 

of these calculations. 

TABLE 8—MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY

Calendar year 

2017 2018 2019 2020 

Medicare EPs who have claims with Medicare (thousands) ........................... 675.5 683.3 691.1 698.8 

Non-Hospital-based Medicare EPs (thousands) ............................................. 609.1 616.1 623.1 630.1 

Percent of EPs who are Meaningful Users ..................................................... 70 73 75 78 

Meaningful Users (thousands) ......................................................................... 426.4 446.7 467.3 488.3 

Our estimates of the incentive 

payment costs and payment adjustment 

savings are presented in Table 9. They 

reflect actual historical data and our 

assumptions about the proportion of EPs 

who will demonstrate meaningful use of 

certified EHR technology. Estimated 

costs are expected to decrease in 2017 

through 2020 due to a smaller number 

of new EPs that would achieve 

meaningful use and the cessation of the 

incentive payment program. Payment 

adjustment receipts represent the 

estimated amount of money collected 

due to the payment adjustments for 

those not achieving meaningful use. 

Estimated net costs for the Medicare EP 

portion of the HITECH Act are also 

shown in Table 9. 

TABLE 9—ESTIMATED COSTS (+) AND SAVINGS (¥) FOR MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF

CERTIFIED EHR TECHNOLOGY

[In Billions] 

Fiscal Year Incentive 

payments 

Payment adjustment 

receipts 

Benefit 

payments Net total 

2017 ................................................................................................................. $0.6 ¥$0.2 — $0.3 

2018 ................................................................................................................. — ¥0.2 — ¥0.2 

2019 ................................................................................................................. — ¥0.2 — ¥0.2 

2020 ................................................................................................................. — ¥0.1 — ¥0.1 

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b. Medicare Eligible Hospitals and 

CAHs 

In brief, the estimates of hospital 

adoption were developed by calculating 

projected incentive payments and then 

making assumptions about how rapidly 

hospitals would adopt meaningful use. 

Specifically, the first step in preparing 

estimates of Medicare program costs for 

eligible hospitals was to determine how 

many eligible hospitals already received 

payments under the EHR Incentive 

program and for what years those 

payments were received. In order to do 

this, we used the most recent available 

data that listed the recipients of 

incentive payments, and the year and 

payment amount. This information 

pertained to eligible hospitals receiving 

payments through September 2014. 

We assume that all eligible hospitals 

that receive a payment in the first year 

will receive payments in future years. 

We also assume the eligible hospitals 

that have not yet received any incentive 

payments will eventually achieve 

meaningful use (either to receive 

incentive payments or to avoid payment 

adjustments). We assume that all 

eligible hospitals would achieve 

meaningful use by 2018. No new 

incentive payments would be paid after 

2016. However, some incentive 

payments originating in 2016 would be 

paid in 2017. 

The average incentive payment for 

each eligible hospital was $1.5 million 

in the first year. In later years, the 

amount of the incentive payments drops 

according to the schedule allowed in 

law. The average incentive payment for 

CAHs received in the first year was 

about $950,000. The average incentive 

payment received in the second year 

was about $332,500. The average 

incentive payment received in the third 

year was about $475,000. These average 

amounts were used for these incentive 

payments in the future. The third year 

average was also used for the fourth 

year. These assumptions about the 

number of hospitals achieving 

meaningful use in a particular year and 

the average amount of an incentive 

payment allows us to calculate the total 

amount of incentive payments to be 

made and the amount of payment 

adjustments for those hospitals who 

have not achieved meaningful use. The 

payment incentives available to 

hospitals under the Medicare and 

Medicaid EHR Incentive Programs are 

included in our regulations at 42 CFR 

part 495. We further estimate that there 

are 16 MA organizations that might be 

eligible to participate in the incentive 

program. Those plans have 32 eligible 

hospitals. The costs for the MA program 

have been included in the overall 

Medicare estimates. 

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 were 

discussed earlier in 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. The results are 

shown in Table 10. 

TABLE 10—ESTIMATED COSTS (+) AND SAVINGS (¥) FOR MEDICARE ELIGIBLE HOSPITALS DEMONSTRATING MEANINGFUL

USE OF CERTIFIED EHR TECHNOLOGY

[In billions] 

Fiscal year Incentive 

payments 

Payment 

adjustment 

receipts 

Benefit 

payments Net total 

2017 ................................................................................................................. $1.6 (1) (1) $1.6 

2018 ................................................................................................................. 0.0 (1) (1) (1) 

2019 ................................................................................................................. 0.0 0.0 (1) (1) 

2020 ................................................................................................................. 0.0 0.0 (1) (1) 

1Savings of less than $50 million. All numbers are projections. 

4. Medicaid Incentive Program Costs 

Under section, 4201 of the HITECH 

Act, states and territories can 

voluntarily participate in the Medicaid 

EHR Incentive Program. However, as of 

the writing of this proposed rule, all 

states already participate. The payment 

incentives available to EPs and eligible 

hospitals under the Medicaid EHR 

Incentive Program 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 

hospitals and EPs. Table 11 shows our 

estimates for the net Medicaid costs for 

eligible hospitals and EPs. 

TABLE 11—ESTIMATED FEDERAL COSTS (+) AND SAVINGS (¥) UNDER MEDICAID

[In $billions] 

Fiscal year 

Incentive payments 

Benefit 

payments Net total 

Hospitals Eligible 

professionals 

2017 ................................................................................................................. 0.4 0.8 (1) 1.2 

2018 ................................................................................................................. 0.1 0.5 (1) 0.6 

2019 ................................................................................................................. 0 0.3 (1) 0.3 

2020 ................................................................................................................. 0.0 0.2 (1) 0.2 

1Savings of less than $50 million. 

a. Medicaid EPs 

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TABLE 12—ASSUMED NUMBER OF NONHOSPITAL BASED MEDICAID EPS WHO WOULD BE MEANINGFUL USERS OF

CERTIFIED EHR TECHNOLOGY

[Population figures in thousands] 

Calendar year 

2017 2018 2019 2020 

A ................................... EPs who meet the Medicaid patient volume threshold ........ 101.3 102.3 103.3 104.4 

B ................................... Medicaid only Eps ................................................................. 60.6 61.7 62.9 64.0 

Total Medicaid EPs (A + B) .................................................. 161.8 164.0 166.2 168.4 

Percent of EPs receiving incentive payment during year ..... 44.7% 30.9% 20.7% 14.3% 

Number of EPs receiving incentive payment during year .... 72.4 50.7 34.5 24.0 

Percent of EPs who have ever received incentive payment 67.9% 74.7% 78.0% 81.1% 

Number of EPs who have ever received incentive payment 109.9 122.5 129.6 136.6 

It should be noted that since the 

Medicaid EHR Incentive Program 

provides that a Medicaid EP can receive 

an incentive payment in his or her 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. 

b. Medicaid Hospitals 

Medicaid incentive payments to most 

eligible hospitals were estimated using 

the same methodology as described 

previously for Medicare eligible 

hospitals and shown in Table 10. Many 

eligible hospitals may qualify to receive 

both the Medicare and Medicaid 

incentive payment. We assume that all 

eligible hospitals would achieve 

meaningful use by 2016. However, 

many of these eligible hospitals would 

have already received the maximum 

amount of incentive payments. Table 13 

shows our assumptions about the 

remaining incentive payments to be 

paid. 

TABLE 13—ESTIMATED PERCENTAGE

OF HOSPITALS THAT COULD BE PAID

FOR MEANINGFUL USE AND ESTIMATED PERCENTAGE PAYABLE IN

YEAR

Fiscal year 

Percent of 

hospitals who 

are meaningful 

users 

Percent of 

hospitals being 

paid 

2017 .......... 100.0 13.5 

2018 .......... 100.0 5.2 

2019 .......... 100.0 1.5 

2020 .......... 100.0 0.0 

As stated previously, the estimated 

eligible hospital incentive payments 

were calculated based on the eligible 

hospitals’ qualifying status and 

individual incentive amounts payable 

under the statutory formula. The 

average Medicaid incentive payment in 

the first year was $1 million. The 

estimated savings in Medicaid benefit 

expenditures resulting from the use of 

certified EHR technology are discussed 

in section V.C.4. of this proposed rule. 

Since we use Medicare 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. 

5. 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. A 

subsequent 2013 study completed by 

the RAND Corporation for ONC 

(Shekelle et al. 2013 ‘‘Health 

Information Technology: An Updated 

Systemic Review with a Focus on 

Meaningful Use Functionalities’’) found 

77 percent of articles published between 

January 2010 to August 2013 that 

evaluated the effects of health IT on 

healthcare quality, safety, and efficiency 

reported findings that were at least 

partially positive. The Centers for 

Disease Control and Prevention 

publication in January 2014, (Hsiao et 

al, ‘‘Use and Characteristics of 

Electronic Health Record Systems 

Among Office-based Physician 

Practices: United states, 2001–2013’’) 

concluded that the adoption of basic 

EHR systems by office-based physicians 

increased 21 percent between 2012 and 

2013, varying widely across the states 

ranging from 21 percent in New Jersey 

to 83 percent in North Dakota. 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-1.) Another 

study compared the productivity of 75 

providers within a large urban primary 

care practice over a 4-year period 

showed increases in productivity of 1.7 

percent per month per provider after 

EHR adoption (DeLeon et al. 2010, ‘‘The 

business end of health information 

technology’’). Some vendors have 

estimated that EHRs could result in cost 

savings of between $100 and $200 per 

patient per year. As participation and 

adoption increases, there will be more 

opportunities to capture and report on 

cost savings and benefits. 

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6. Benefits to Society 

According to the CBO study 

‘‘Evidence on the Costs and Benefits of 

Health Information Technology’’ (http:// 

www.cbo.gov//ftpdocs/91xx/doc9168/

05-20-HealthIT.pdf) when used 

effectively, EHRs can enable providers 

to deliver health care more efficiently. 

For example, the study states that EHRs 

can reduce the duplication of diagnostic 

tests, prompt providers to prescribe 

cost-effective generic medications, 

remind patients about preventive care, 

reduce unnecessary office visits, and 

assist in managing complex care. This is 

consistent with the findings in the ONC 

study cited previously. Further, the CBO 

report claims that there is a potential to 

gain both internal and external savings 

from widespread adoption of health IT, 

noting that internal savings will likely 

be in the reductions in the cost of 

providing care, and that external savings 

could accrue to the health insurance 

plan or even the patient, such as the 

ability to exchange information more 

efficiently. However, it is important to 

note that the CBO identifies the highest 

gains accruing to large provider systems 

and groups and claims that office-based 

physicians may not realize similar 

benefits from purchasing health IT 

products. At this time, there is limited 

data regarding the efficacy of health IT 

for smaller practices and groups, and 

the CBO report notes that this is a 

potential area of research and analysis 

that remains unexamined. The benefits 

resulting specifically from this proposed 

rule are even harder to quantify because 

they represent, in many cases, adding 

functionality to existing systems and 

reaping the network externalities 

created by larger numbers of providers 

participating in information exchange. 

In the Stage 2 final rule at 77 FR 

54144, we discussed research 

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). The 2013 ONC report 

cited previously reported findings from 

their literature review on health IT and 

safety of care, health IT and quality of 

care, health IT and safety of care, and 

health It and efficiency of care in 

ambulatory and non-ambulatory care 

settings. The report indicated that a 

majority of studies that evaluated the 

effects of health IT on healthcare 

quality, safety, and efficiency reported 

findings that were at least partially 

positive. The report concluded that their 

findings ‘‘suggested that health IT, 

particularly those functionalities 

included in the Meaningful Use . . ., 

can improve healthcare quality and 

safety.’’ However, data relating 

specifically to the EHR Incentive 

Programs is limited at this time. 

7. Summary 

In this proposed rule, the total cost to 

the Medicare and Medicaid programs 

between 2017 and 2020 is estimated to 

be $3.7 billion in transfers. As discussed 

in section V.C.4. of this proposed rule, 

we do not estimate total costs to the 

provider industry, but rather provide a 

possible per EP and per eligible hospital 

outlay for implementation and 

maintenance. 

TABLE 14—ESTIMATED EHR INCENTIVE PAYMENTS AND BENEFITS IMPACTS ON THE MEDICARE AND MEDICAID PROGRAMS

OF THE HITECH EHR INCENTIVE PROGRAM (FISCAL YEAR) 

[In billions] 

Fiscal year 

Medicare eligible Medicaid eligible 

Total 

Hospitals Professionals Hospitals Professionals 

2017 ..................................................................................... $1.6 $0.3 $0.4 $0.8 $3.1 

2018 ..................................................................................... 0.0 ¥0.2 0.1 0.5 0.4 

2019 ..................................................................................... 0.0 ¥0.2 0.0 0.3 0.1 

2020 ..................................................................................... 0.0 ¥0.1 0.0 0.2 0.1 

Total .............................................................................. 1.6 ¥0.2 0.5 1.8 3.7 

D. Alternatives Considered 

As stated in the Stage 1 final rule (75 

FR 44546), HHS has no discretion to 

change the incentive payments or 

payment adjustment reductions 

specified in the statute for providers 

that adopt or fail to adopt a certified 

EHR and demonstrate meaningful use of 

certified EHR technology. However, we 

have discretion around how best to meet 

the HITECH Act requirements for 

meaningful use for FY 2017 and 

subsequent years, which we have 

exercised in this proposed rule. 

Additionally, we have used our 

discretion to appropriately propose the 

timing of registration, attestation and 

payment requirements to allow EPs and 

eligible organizations as much time as 

possible in coordination with the 

anticipated certification of EHR 

technology to obtain and meaningfully 

use certified EHRs. We recognize that 

there may be additional costs that result 

from various discretionary policy 

choices by providers. However, those 

costs cannot be estimated and are not 

captured in this analysis. 

E. Accounting Statement and Table 

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 non-budgetary costs are 

presented as discounted flows using 3 

percent and 7 percent factors in the 

following Table 15. 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. We note that federal 

annualized monetized transfers 

represent the net total of annual 

incentive payments in the Medicare and 

Medicaid EHR Incentive programs less 

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the reductions in Medicare payments to 

providers failing to demonstrate 

meaningful use as a result of the related 

Medicare payment adjustments. 

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 15—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES CYS 2017 THROUGH 2020 

[In millions] 

CATEGORY 

BENEFITS 

Qualitative ........................................................................................................ Expected qualitative benefits include improved quality of care, 

better health outcomes, reduced errors and the like. 

COSTS 

Year dollar Estimates 

(in millions) 

Unit discount 

rate 

Period 

covered 

........................ Primary 

Estimate 

Annualized Monetized Costs to Private Industry Associated with Reporting 

Requirements ............................................................................................... 2017 $478.1 

$478.4 

7% 

3% 

CY 2017 

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 dollar Estimates 

(in millions) 

Unit discount 

rate 

Period 

covered 

Federal Annualized Monetized ........................................................................ 2017 $1,000.4 

$954.8 

7% 

3% 

CYs 2017– 

2020 

From Whom To Whom? .................................................................................. Federal Government to Medicare- and Medicaid-eligible 

professionals and hospitals. 

F. 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. 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. Health IT can enable providers to 

deliver health care more efficiently. For 

example, EHRs can reduce the 

duplication of diagnostic tests, prompt 

providers to prescribe cost-effective 

generic medications, remind patients 

about preventive care, reduce 

unnecessary office visits, and assist in 

managing complex care. We also believe 

that internal savings will likely come 

through the reductions in the cost of 

providing care. We believe that the net 

effect on individual providers may be 

positive over time in many 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, the Office of 

Management and Budget reviewed this 

rule. 

List of Subjects in 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 part 495 as set forth below: 

PART 495—STANDARDS FOR THE 

ELECTRONIC HEALTH RECORD 

TECHNOLOGY INCENTIVE PROGRAM 

■ 1. 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). 

■ 2. Section 495.4 is amended as 

follows: 

■ A. Adding the definition for 

‘‘Application-program interface (API)’’. 

■ B. Revising the definition of ‘‘Certified 

electronic health record technology’’. 

■ C. Amending the definition of ‘‘EHR 

reporting period’’ by— 

■ i. Redesignating paragraphs (1)(i), 

(1)(ii), (1)(iii) introductory text, 

(1)(iii)(A), (1)(iii)(B), (1)(iii)(C), 

(1)(iii)(D), and (1)(iv) as paragraphs 

(1)(i)(A), (1)(i)(B), (1)(i)(C) introductory 

text, (1)(i)(C)(1), (1)(i)(C)(2), (1)(i)(C)(3), 

(1)(1)(C)(4), and (1)(i)(D), respectively. 

■ ii. Adding new paragraph (1)(i) 

introductory text. 

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■ iii. Adding a new paragraph (1)(ii). 

■ iv. Redesignating paragraphs (2)(i), 

(2)(ii), (2)(iii) introductory text, 

(2)(iii)(A), (2)(iii)(B), (2)(iii)(C), and 

(2)(iii)(D), as paragraphs (2)(i)(A), 

(2)(i)(B), (2)(i)(C) introductory text and 

(2)(i)(C)(1), (2)(i)(C)(2), (2)(i)(C)(3), and 

(2)(i)(C)(4), respectively. 

■ v. Adding new paragraph (2)(i) 

introductory text. 

■ vi. Adding a new paragraph (2)(ii). 

■ D. Amending the definition of ‘‘EHR 

reporting period for a payment 

adjustment year’’ by: 

■ i. Redesignating paragraphs (1)(i)(A), 

(1)(i)(B), (1)(ii), (1)(iii)(A), and (1)(iii)(B) 

as paragraphs (1)(i)(A)(1), (1)(i)(A)(2), 

(1)(i)(B), (1)(i)(C)(1) and (1)(i)(C)(2), 

respectively. 

■ ii. In newly redesignated paragraph 

(1)(i)(A)(1), by removing the crossreference ‘‘paragraphs (1)(i)(B), (ii), and 

(iii)’’ and adding in its place the crossreference ‘‘paragraphs (1)(i)(A)(2), 

(1)(i)(B), and (1)(i)(C)’’. 

■ iii. In newly redesignated paragraph 

(1)(i)(A)(2), by removing the crossreference ‘‘paragraphs (1)(iii) or (iv)’’ 

and adding in its place the crossreference ‘‘paragraph (1)(i)(C)’’. 

■ iv. Adding new paragraph (1)(i) 

introductory text. 

■ v. Adding a new paragraph (1)(ii). 

■ vi. Redesignating paragraphs (2)(i)(A), 

(2)(i)(B), (2)(ii), (2)(iii)(A), and (2)(iii)(B) 

as paragraphs (2)(i)(A)(1), (2)(i)(A)(2), 

(2)(i)(B), (2)(i)(C)(1) and (2)(i)(C)(2), 

respectively. 

■ vii. In newly redesignated paragraph 

(2)(i)(A)(1), by removing the crossreference ‘‘paragraphs (2)(i)(B), (ii), and 

(iii)’’ and adding in its place the crossreference ‘‘paragraphs (2)(i)(A)(2), 

(2)(i)(B), and (2)(i)(C)’’. 

■ viii. In newly redesignated paragraph 

(2)(i)(A)(2), by removing the crossreference ‘‘paragraph (2)(iii)’’ and 

adding in its place the cross-reference 

‘‘paragraph (2)(i)(C)’’. 

■ ix. Adding new paragraph (2)(i) 

introductory text. 

■ x. Adding new paragraph (2)(ii). 

■ xi. Redesignating paragraphs (3)(i) and 

(3)(ii) as paragraphs (3)(i)(A) and 

(3)(i)(B). 

■ xii. In newly redesignated paragraph 

(3)(i)(A), by removing the crossreference ‘‘paragraph (3)(ii)’’ and adding 

in its place the cross-reference 

‘‘paragraph (3)(i)(B)’’. 

■ xiii. Adding new paragraph (3)(i) 

introductory text. 

■ xiv. Adding new paragraph (3)(ii). 

■ E. In the paragraph (1) of the 

definition of ‘‘Meaningful EHR User’’ by 

removing the reference ‘‘under § 495.6’’ 

and adding in its place the reference to 

‘‘under § 495.6 or 495.7’’. 

The additions read as follows: 

§ 495.4 Definitions. 

* * * * * 

Application-program interface (API) 

means a set of programming protocols 

established for multiple purposes. APIs 

may be enabled by a provider or 

provider organization to provide the 

patient with access to their health 

information through a third-party 

application with more flexibility than 

often found in many current ‘‘patient 

portals.’’ 

Certified electronic health record 

technology (CEHRT) means the 

following: 

(1) For any Federal fiscal year (FY) or 

calendar year (CY) before 2018, EHR 

technology (which could include 

multiple technologies) certified under 

the ONC Health IT Certification Program 

that— 

(i) Meets the— 

(A) 2014 Edition Base EHR definition 

(as defined at 45 CFR 170.102); or 

(B) 2015 Edition Base EHR definition 

(as defined at 45 CFR 170.102); or 

(ii) Has been certified to the following 

certification criteria: 

(A)(1) CPOE at— 

(i) 45 CFR 170.314(a)(1), (18), (19) or 

(20); or 

(ii) 45 CFR 170.315(a)(1), (2) or (3); 

(2)(i) Record demographics at 45 CFR 

170.314(a)(3); or 

(ii) 45 CFR 170.315(a)(5). 

(3)(i) Problem list at 45 CFR 

170.314(a)(5); or 

(ii) 45 CFR 170.315(a)(7). 

(4)(i) Medication list at 45 CFR 

170.314(a)(6); or (ii) 45 CFR 

170.315(a)(8). 

(5)(i) Medication allergy list 45 CFR 

170.314(a)(7); or (ii) 45 CFR 

170.315(a)(9); 

(6)(i) Clinical decision support at 45 

CFR 170.314(a)(8); or (ii) 45 CFR 

170.315(a)(10). 

(7) Health information exchange at 

transitions of care at one of the 

following: 

(i) 45 CFR 170.314(b)(1) and (2). 

(ii) 45 CFR 170.314(b)(1), (b)(2), and 

(h)(1). 

(iii) 45 CFR 170.314(b)(1), (b)(2), and 

(b)(8). 

(iv) 45 CFR 170.314(b)(1), (b)(2), 

(b)(8), and (h)(1). 

(v) 45 CFR 170.314(b)(8) and (h)(1). 

(vi) 45 CFR 170.314(b)(1), (b)(2), and 

170.315(h)(2). 

(vii) 45 CFR 170.314(b)(1), (b)(2), 

(h)(1), and 170.315(h)(2). 

(viii) 45 CFR 170.314(b)(1), (b)(2), 

(b)(8), and 170.315(h)(2). 

(ix) 45 CFR 170.314(b)(1), (b)(2), 

(b)(8), (h)(1), and 170.315(h)(2). 

(x) 45 CFR 170.314(b)(8), (h)(1), and 

170.315(h)(2). 

(xi) 45 CFR 170.314(b)(1), (b)(2), and 

170.315(b)(1). 

(xii) 45 CFR 170.314(b)(1), (b)(2), 

(h)(1), and 170.315(b)(1). 

(xiii) 45 CFR 170.314(b)(1), (b)(2), 

(b)(8), and 170.315(b)(1). 

(xiv) 45 CFR 170.314(b)(1), (b)(2), 

(b)(8), (h)(1), and 170.315(b)(1). 

(xv) 45 CFR 170.314(b)(8), (h)(1), and 

170.315(b)(1). 

(xvi) 45 CFR 170.314(b)(1), (b)(2), 

(b)(8), (h)(1), 170.315(b)(1), and 

170.315(h)(1). 

(xvii) 45 CFR 170.314(b)(1), (b)(2), 

(b)(8), (h)(1), 170.315(b)(1), and 

170.315(h)(2). 

(xviii) 45 CFR 170.314(h)(1) and 

170.315(b)(1). 

(xix) 45 CFR 170.315(b)(1) and (h)(1). 

(xx) 45 CFR 170.315(b)(1) and (h)(2). 

(xxi) 45 CFR 170.315(b)(1), (h)(1), and 

(h)(2). 

(B) Clinical quality measures at 45 

CFR 170.314(c)(1) or 170.315(c)(1). 

(C) The 2014 Edition or 2015 Edition 

certification criteria that are necessary 

to be a Meaningful EHR User (as defined 

in this section), including the following: 

(1) The applicable automated 

numerator recording and automated 

measure calculation certification criteria 

that support attestation as a Meaningful 

EHR User at 45 CFR 170.315(g)(1) and 

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

(2) Clinical quality measure 

certification criteria that support the 

calculation and reporting of clinical 

quality measures at 45 CFR 

170.314(c)(2) and (c)(3) or 45 CFR 

170.315(c)(2) and (c)(3). 

(2) For 2018 and subsequent years, 

EHR technology (which could include 

multiple technologies) certified under 

the ONC Health IT Certification Program 

that meets the 2015 Edition Base EHR 

definition (as defined at 45 CFR 

170.102) and has been certified to the 

2015 Edition health IT certification 

criteria that— 

(i)(A) Include the capabilities to 

record 45 CFR 170.315(a)(14); or 

(B) Create and incorporate family 

health history 45 CFR 170.315(a)(15). 

(ii) Include the capabilities that 

support patient health information 

capture at 45 CFR 170.315(a)(19); and 

(iii) Are necessary to be a Meaningful 

EHR User (as defined in this section), 

including the following: 

(A) The applicable automated 

numerator recording and automated 

measure calculation certification criteria 

that support attestation as a Meaningful 

EHR User at 45 CFR 170.315(g)(1) and 

(2). 

(B) Clinical quality measure 

certification criteria that support the 

calculation and reporting of clinical 

quality measures under the 2015 Edition 

certification criteria 45 CFR 

170.315(c)(2) and (c)(3). 

* * * * * 

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EHR reporting period. * * * 

(1) * * * 

(i) The following are applicable before 

CY 2017. 

* * * * * 

(ii) The following are applicable 

beginning in CY 2017 under the 

Medicaid EHR Incentive Program: 

(A) For the payment year in which the 

EP is first demonstrating he or she is a 

meaningful EHR user, any continuous 

90-day period within the calendar year. 

(B) 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) * * * 

(i) The following are applicable before 

CY 2017: 

* * * * * 

(ii) The following are applicable 

beginning in CY 2017 under the 

Medicaid EHR Incentive Program: 

(A) 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 calendar year. 

(B) 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 calendar year. 

EHR reporting period for a payment 

adjustment year. * * * 

(1) * * * 

(i) The following are applicable before 

CY 2017: 

* * * * * 

(ii) The following are applicable 

beginning in CY 2017: 

(A) Except as provided under 

paragraph (1)(ii)(B) of this definition, 

the calendar year that is 2 years before 

the payment adjustment year. 

(B) If an EP is demonstrating under 

the Medicaid EHR Incentive Program 

that 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 the continuous 

90-day period that is the EHR reporting 

period for the Medicaid incentive 

payment within such (2 years prior) 

calendar year. 

(2) * * * 

(i) The following are applicable before 

CY 2017: 

* * * * * 

(ii) The following are applicable 

beginning in CY 2017: 

(A) Except as provided in paragraph 

(2)(ii)(B) of this definition, the calendar 

year that is 2 years before the payment 

adjustment year. 

(B) If an eligible hospital is 

demonstrating under the Medicaid EHR 

Incentive Program that it is a 

meaningful EHR user for the first time 

in the calendar year that is 2 years 

before the payment adjustment year, 

then the continuous 90-day period that 

is the EHR reporting period for the 

Medicaid incentive payment within 

such (2 years prior) calendar year. 

(3) * * * 

(i) The following are applicable before 

CY 2017: 

* * * * * 

(ii) The following are applicable 

beginning in CY 2017: 

(A) Except as provided in paragraph 

(3)(ii)(B) of this definition, the calendar 

year that begins on the first day of the 

second quarter of the Federal fiscal year 

that is the payment adjustment year. 

(B) If a CAH is demonstrating under 

the Medicaid EHR Incentive Program 

that it is a meaningful EHR user for the 

first time in the calendar year that 

begins on the first day of the second 

quarter of the Federal fiscal year that is 

the payment adjustment year, then any 

continuous 90-day period within such 

calendar year. 

* * * * * 

■ 3. Section 495.6 is amended by 

revising the section heading and adding 

introductory text to read as follows: 

§ 495.6 Meaningful use objectives and 

measures for EPs, eligible hospitals, and 

CAHs before 2018. 

The following criteria are applicable 

before 2018: 

* * * * * 

■ 4. Section 495.7 is added to read as 

follows: 

§ 495.7 Stage 3 meaningful use objectives 

and measures for EPs, eligible hospitals, 

and CAHs for 2018 and subsequent years. 

The following criteria are optional for 

EPs, eligible hospitals, and CAHs in 

2017 as outlined at § 495.8(a)(2)(i)(E)(3) 

and (b)(2)(E)(3) and applicable for all 

EPs, eligible hospitals, and CAHs for 

2018 and subsequent years: 

(a) Stage 3 criteria for EPs. 

(1) General rule regarding Stage 3 

criteria for meaningful use for EPs. 

Except as specified in paragraphs (a)(2) 

through (a)(3) of this section, EPs must 

meet all objectives and associated 

measures of the Stage 3 criteria 

specified in paragraph (d) of this section 

to meet the definition of a meaningful 

EHR user. 

(2) Selection of measures for specified 

objectives in paragraph (d) of this 

section. An EP may meet the criteria for 

2 out of the 3 measures associated with 

an objective, rather than meeting the 

criteria for all 3 of the measures, if the 

EP meets all of the following 

requirements: 

(i) Must ensure that the objective in 

paragraph (d) of this section includes an 

option to meet 2 out of the 3 associated 

measures. 

(ii) Meets the threshold for 2 out of 

the 3 measures for that objective. 

(iii) Attests to all 3 of the measures for 

that objective 

(3) Exclusion for nonapplicable 

objectives and measures. 

(i) An EP may exclude a particular 

objective that includes an option for 

exclusion contained in paragraph (d) of 

this section, if the EP meets all of the 

following requirements: 

(A) Meets the criteria in the 

applicable objective that would permit 

the exclusion. 

(B) Attests to the exclusion. 

(ii) An EP may exclude a measure 

within an objective which allows for a 

provider to meet the threshold for 2 of 

the 3 measures, as outlined in paragraph 

(a)(2) of this section, in the following 

manner: 

(A)(1) Meets the criteria in the 

applicable measure or measures that 

would permit the exlusion; and 

(2) Attests to the exclusion or 

exclusions. 

(B)(1) Meets the threshold; and 

(2) Attests to any remaining measure 

or measures. 

(4) Exception for Medicaid EPs who 

adopt, implement or upgrade in their 

first payment year. For Medicaid EPs 

who adopt, implement or upgrade its 

certified EHR technology in their first 

payment year, the meaningful use 

objectives and associated measures of 

the Stage 3 criteria specified in 

paragraph (d) of this section, apply 

beginning with the second payment 

year, and do not apply to the first 

payment year. 

(b) Stage 3 criteria for eligible 

hospitals and CAHs. 

(1) General rule regarding Stage 3 

criteria for meaningful use for eligible 

hospitals or CAHs. Except as specified 

in paragraphs (b)(2) through (b)(3) of 

this section, eligible hospitals and CAHs 

must meet all objectives and associated 

measures of the Stage 3 criteria 

specified in paragraph (d) of this section 

to meet the definition of a meaningful 

EHR user. 

(2) Selection of measures for specified 

objectives in paragraph (d) of this 

section. An eligible hospital or CAH 

may meet the criteria for 2 out of the 3 

measures associated with an objective, 

rather than meeting the criteria for all 3 

of the measures, if the eligible hospital 

or CAH meets all of the following 

requirements: 

(i) Must ensure that the objective in 

paragraph (d) of this section includes an 

option to meet 2 out of the 3 associated 

measures. 

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(ii) Meets the threshold for 2 out of 

the 3 measures for that objective. 

(iii) Attests to all 3 of the measures for 

that objective. 

(3) Exclusion for nonapplicable 

objectives and measures. 

(i) An eligible hospital or CAH may 

exclude a particular objective that 

includes an option for exclusion 

contained in paragraph (d) of this 

section, if the eligible hospital or CAH 

meets all of the following requirements: 

(A) Meets the criteria in the 

applicable objective that would permit 

the exclusion. 

(B) Attests to the exclusion. 

(ii) An eligible hospital or CAH may 

exclude a measure within an objective 

which allows for a provider to meet the 

threshold for 2 of the 3 measures, as 

outlined in paragraph (b)(2) of this 

section, in the following manner: 

(A)(1) Meets the criteria in the 

applicable measure or measures that 

would permit the exclusion; and 

(2) Attests to the exclusion or 

exclusions. 

(B)(1) Meets the threshold; and 

(2) Attests to any remaining measure 

or measures. 

(4) Exception for Medicaid eligible 

hospitals or CAHs that adopt, 

implement or upgrade in their first 

payment year. For Medicaid eligible 

hospitals or CAHs who adopt, 

implement or upgrade certified EHR 

technology in their first payment year, 

the meaningful use objectives and 

associated measures of the Stage 3 

criteria specified in paragraph (d) of this 

section apply beginning with the second 

payment year, and do not apply to the 

first payment year. 

(c) Objectives and associated 

measures in paragraph (d) of this 

section that rely on measures that count 

unique patients or actions. 

(1) If a measure (or associated 

objective) in paragraph (d) of this 

section references paragraph (c) of this 

section, then the measure may be 

calculated by reviewing only the actions 

for patients whose records are 

maintained using certified EHR 

technology. A patient’s record is 

maintained using certified EHR 

technology if sufficient data was entered 

in the certified EHR technology to allow 

the record to be saved, and not rejected 

due to incomplete data. 

(2) If the objective and associated 

measure does not reference this 

paragraph (c) of this section, then the 

measure must be calculated by 

reviewing all patient records, not just 

those maintained using certified EHR 

technology. 

(d) Stage 3 objectives and measures 

for EPs, eligible hospitals, and CAHs. 

(1) Protect patient health information. 

(i) EP protect patient health 

information. 

(A) Objective. Protect electronic 

protected health information (ePHI) 

created or maintained by the certified 

EHR technology (CEHRT) through the 

implementation of appropriate 

technical, administrative, and physical 

safeguards. 

(B) Measure. Conduct or review a 

security risk analysis in accordance 

with the requirements under 45 CFR 

164.308(a)(1), including: 

(1) Addressing the security (including 

encryption) of data stored in CEHRT in 

accordance with requirements under 45 

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

164.306(d)(3), 

(2) Implement security updates as 

necessary, and 

(3) Correct identified security 

deficiencies as part of the EP’s risk 

management process. 

(ii) Eligible hospital/CAH protect 

patient health information. 

(A) Objective. Protect electronic 

protected health information (ePHI) 

created or maintained by the certified 

EHR technology (CEHRT) through the 

implementation of appropriate 

technical, administrative, and physical 

safeguards. 

(B) Measure. Conduct or review a 

security risk analysis in accordance 

with the requirements under 45 CFR 

164.308(a)(1), including— 

(1) Addressing the security (including 

encryption) of data stored in CEHRT in 

accordance with requirements under 45 

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

164.306(d)(3); 

(2) Implement security updates as 

necessary; and 

(3) Correct identified security 

deficiencies as part of the eligible 

hospital’s or CAH’s risk management 

process. 

(2) Electronic prescribing. 

(i) EP electronic prescribing. 

(A) Objective. Generate and transmit 

permissible prescriptions electronically 

(eRx). 

(B) Measure. Subject to paragraph (c) 

of this section, more than 80 percent of 

all permissible prescriptions written by 

the EP are queried for a drug formulary 

and transmitted electronically using 

certified EHR technology (CEHRT). 

(C) Exclusions in accordance with 

paragraph (a)(3) of this section. 

(1) Any EP who writes fewer than 100 

permissible prescriptions during the 

EHR reporting period; or 

(2) Any EP who does not have a 

pharmacy within its organization and 

there are no pharmacies that accept 

electronic prescriptions within 10 miles 

of the EP’s practice location at the start 

of his/her EHR reporting period. 

(ii) Eligible hospital/CAH electronic 

prescribing. 

(A) Objective. Generate and transmit 

permissible discharge prescriptions 

electronically (eRx). 

(B) Measure. Subject to paragraph (c) 

of this section, more than 25 percent of 

hospital discharge medication orders for 

permissible prescriptions (for new and 

changed prescriptions) are queried for a 

drug formulary and transmitted 

electronically using certified EHR 

technology (CEHRT). 

(C) Exclusions in accordance with 

paragraph (b)(3) of this section. Any 

eligible hospital or CAH that does not 

have an internal pharmacy that can 

accept electronic prescriptions and 

there are no pharmacies that accept 

electronic prescriptions within 10 miles 

at the start of the eligible hospital’s or 

CAH’s EHR reporting period. 

(3) Clinical decision support. 

(i) EP clinical decision support. 

(A) Objective. Implement clinical 

decision support (CDS) interventions 

focused on improving performance on 

high-priority health conditions. 

(B) Measures. 

(1) Implement five clinical decision 

support interventions related to four or 

more clinical quality measures (CQMs) 

at a relevant point in patient care for the 

entire EHR reporting period. Absent 

four clinical quality measures related to 

an EP’s scope of practice or patient 

population, the clinical decision 

support interventions must be related to 

high-priority health conditions; and 

(2) The EP has enabled and 

implemented the functionality for drugdrug and drug-allergy interaction checks 

for the entire EHR reporting period. 

(C) Exclusion in accordance with 

paragraph (a)(3) of this section for 

paragraph (d)(3)(i)(B)(2) of this section. 

An EP who writes fewer than 100 

medication orders during the EHR 

reporting period. 

(ii) Eligible hospital/CAH clinical 

decision support. 

(A) Objective. Implement clinical 

decision support (CDS) interventions 

focused on improving performance on 

high-priority health conditions. 

(B) Measures. 

(1) Implement five clinical decision 

support interventions related to four or 

more clinical quality measures at a 

relevant point in patient care for the 

entire EHR reporting period. Absent 

four clinical quality measures (CQMs) 

related to an eligible hospital or CAH’s 

patient population, the clinical decision 

support interventions must be related to 

high-priority health conditions; and 

(2) The eligible hospital or CAH has 

enabled and implemented the 

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allergy interaction checks for the entire 

EHR reporting period. 

(4) Computerized provider order entry 

(CPOE). 

(i) EP CPOE. 

(A) Objective. Use computerized 

provider order entry (CPOE) for 

medication, laboratory, and diagnostic 

imaging orders directly entered by any 

licensed healthcare professional, 

credentialed medical assistant, or a 

medical staff member credentialed to 

and performing the equivalent duties of 

a credentialed medical assistant; who 

can enter orders into the medical record 

per state, local, and professional 

guidelines. 

(B) Measures. Subject to paragraph (c) 

of this section— 

(1) More than 80 percent of 

medication orders created by the EP 

during the EHR reporting period are 

recorded using computerized provider 

order entry; 

(2) More than 60 percent of laboratory 

orders created by the EP during the EHR 

reporting period are recorded using 

computerized provider order entry; and 

(3) More than 60 percent of diagnostic 

imaging orders created by the EP during 

the EHR reporting period are recorded 

using computerized provider order 

entry. 

(C) Exclusions in accordance with 

paragraph (a)(3) of this section. 

(1) For the measure specified in 

paragraph (d)(4)(i)(B)(1) of this section, 

any EP who writes fewer than 100 

medication orders during the EHR 

reporting period. 

(2) For the measure specified in 

paragraph (d)(4)(i)(B)(2) of this section, 

any EP who writes fewer than 100 

laboratory orders during the EHR 

reporting period. 

(3) For the measure specified in 

paragraph (d)(4)(i)(B)(3) of this section, 

any EP who writes fewer than 100 

diagnostic imaging orders during the 

EHR reporting period. 

(ii) Eligible hospital and CAH CPOE. 

(A) Objective. Use computerized 

provider order entry (CPOE) for 

medication, laboratory, and diagnostic 

imaging orders directly entered by any 

licensed healthcare professional, 

credentialed medical assistant, or a 

medical staff member credentialed to 

and performing the equivalent duties of 

a credentialed medical assistant; who 

can enter orders into the medical record 

per state, local, and professional 

guidelines. 

(B) Measures. Subject to paragraph (c) 

of this section, more than— 

(1) Eighty percent of medication 

orders created by authorized providers 

of the eligible hospital’s or CAH’s 

inpatient or emergency department 

(POS 21 or 23) during the EHR reporting 

period are recorded using computerized 

provider order entry; 

(2) Sixty percent of laboratory orders 

created by authorized providers of the 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period are 

recorded using computerized provider 

order entry; and 

(3) Sixty percent of diagnostic 

imaging orders created by authorized 

providers of the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period are recorded using 

computerized provider order entry. 

(5) Patient electronic access to health 

information. 

(i) EP patient electronic access to 

health information. 

(A) Objective. The EP provides access 

for patients to view online, download, 

and transmit their health information, or 

retrieve their health information 

through an application-program 

interface (API), within 24 hours of its 

availability. 

(B) Measures. EPs must meet the 

following two measures: 

(1) For more than 80 percent of all 

unique patients seen by the EP)— 

(i) The patient (or patient authorized 

representatives) is provided access to 

view online, download, and transmit 

their health information within 24 hours 

of its availability to the provider; or 

(ii) The patient (or patient authorized 

representatives) is provided access to an 

ONC-certified application-program 

interface (API) that can be used by thirdparty applications or devices to provide 

patients (or patient authorized 

representatives) access to their health 

information, within 24 hours of its 

availability to the provider. 

(2) The EP must use clinically 

relevant information from CEHRT to 

identify patient-specific educational 

resources and provide electronic access 

to those materials to more than 35 

percent of unique patients seen by the 

EP during the EHR reporting period. 

(C) Exclusions in accordance with 

paragraph (a)(3) of this section. 

(1) Any EP who has no office visits 

during the reporting period may exclude 

from the measures specified in 

paragraphs (d)(7)(i)(B)(1) and (B)(2) of 

this section. 

(2) 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 from the measures specified in 

paragraphs (d)(7)(i)(B)(1) and (2) of this 

section. 

(ii) Eligible hospital and CAH patient 

electronic access to health information. 

(A) Objective. The eligible hospital or 

CAH provides access for patients to 

view online, download, and transmit 

their health information, or retrieve 

their health information through an 

application-program interface (API), 

within 24 hours of its availability. 

(B) Measures. Eligible hospitals and 

CAHs must meet the following two 

measures: 

(1) For more than 80 percent of all 

unique patients discharged from the 

eligible hospital or CAH inpatient or 

emergency department (POS 21 or 23)— 

(i) The patient (or patient authorized 

representatives) is provided access to 

view online, download, and transmit 

their health information within 24 hours 

of its availability to the provider; or 

(ii) The patient (or patient authorized 

representatives) is provided access to an 

ONC-certified application-program 

interface (API) that can be used by thirdparty applications or devices to provide 

patients (or patient authorized 

representatives) access to their health 

information, within 24 hours of its 

availability to the provider. 

(2) The eligible hospital or CAH must 

use clinically relevant information from 

CEHRT to identify patient-specific 

educational resources and provide 

electronic access to those materials to 

more than 35 percent of unique patients 

discharged from the eligible hospital or 

CAH inpatient or emergency department 

(POS 21 or 23) during the EHR reporting 

period. 

(C) Exclusion in accordance with 

paragraph (b)(3) 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 on the first day 

of the EHR reporting period is excluded 

from the measures specified in 

paragraphs (d)(7)(ii)(B)(1) and (2) of this 

section. 

(6) Coordination of care through 

patient engagement. 

(i) EP coordination of care through 

patient engagement. 

(A) Objective. Use communications 

functions of certified EHR technology to 

engage with patients or their authorized 

representatives about the patient’s care. 

(B) Measures. In accordance with 

paragraph (a)(2) of this section, an EP 

must satisfy 2 out of the 3 following 

measures in paragraphs (d)(5)(i)(B)(1), 

(2), and (3) of this section except those 

measures for which an EP qualifies for 

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an exclusion under paragraph (a)(3) of 

this section. 

(1) During the EHR reporting period, 

more than 25 percent of all unique 

patients seen by the EP actively engage 

with the electronic health record made 

accessible by the provider. An EP may 

meet measure specified in paragraph 

(d)(5)(i)(B)(1) of this paragraph by 

either— 

(i) More than 25 percent of all unique 

patients (or patient-authorized 

representatives) seen by the EP during 

the EHR reporting period view, 

download or transmit to a third party 

their health information; or 

(ii) More than 25 percent of all unique 

patients (or patient-authorized 

representatives) seen by the EP during 

the EHR reporting period access their 

health information through the use of an 

ONC-certified API that can be used by 

third-party applications or devices. 

(2) For more than 35 percent of all 

unique patients seen by the EP during 

the EHR reporting period, a secure 

message was sent using the electronic 

messaging function of CEHRT to the 

patient (or their authorized 

representatives), or in response to a 

secure message sent by the patient. 

(3) Patient generated health data or 

data from a nonclinical setting is 

incorporated into the certified EHR 

technology for more than 15 percent of 

all unique patients seen by the EP 

during the EHR reporting period. 

(C) Exclusions in accordance with 

paragraph (a)(3) of this section. 

(1) Any EP who has no office visits 

during the reporting period may exclude 

from the measures specified in 

paragraphs (d)(5)(i)(B)(1), (B)(2) and 

(B)(3) of this section. 

(2) 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 from the measures specified in 

paragraphs (d)(5)(i)(B)(1), (B)(2) and 

(B)(3) of this section. 

(ii) Eligible hospital and CAH 

coordination of care through patient 

engagement. 

(A) Objective. Use communications 

functions of certified EHR technology to 

engage with patients or their authorized 

representatives about the patient’s care. 

(B) Measures. In accordance with 

paragraph (b)(2) of this section, an 

eligible hospital or CAH must satisfy 2 

of the 3 following measures in 

paragraph (d)(5)(ii)(B)(1), (2), and (3) of 

this section, except those measures for 

which an eligible hospital or CAH 

qualifies for an exclusion under 

paragraph (b)(3) of this section. 

(1) During the EHR reporting period, 

more than 25 percent of all unique 

patients discharged from the eligible 

hospital or CAH inpatient or emergency 

department (POS 21 or 23) actively 

engage with the electronic health record 

made accessible by the provider. An 

eligible hospital or CAH may meet the 

measure specified in paragraph 

(d)(5)(ii)(B)(1) of this section by 

having— 

(i) More than 25 percent of all unique 

patients (or patient-authorized 

representatives) discharged from the 

eligible hospital or CAH inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period view, 

download or transmit to a third party 

their health information; or 

(ii) More than 25 percent of all unique 

patients (or patient-authorized 

representatives) discharged from the 

eligible hospital or CAH inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period access 

their health information through the use 

of an ONC-certified API that can be used 

by third-party applications or devices. 

(2) For more than 35 percent of all 

unique patients discharged from the 

eligible hospital or CAH inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period, a 

secure message was sent using the 

electronic messaging function of CEHRT 

to the patient (or their authorized 

representatives), or in response to a 

secure message sent by the patient. 

(3) Patient generated health data or 

data from a non-clinical setting is 

incorporated into the certified EHR 

technology for more than 15 percent of 

unique patients discharged from the 

eligible hospital or CAH inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period. 

(C) Exclusions under paragraph (b)(3) 

of this section. 

(1) Any eligible hospital or CAH 

operating in a location 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 from the measures 

specified in pargraphs (d)(5)(ii)(B)(1), 

(B)(2), and (B)(3) of this section. 

(7) Health information exchange. 

(i) EP health information exchange. 

(A) Objective. The EP provides a 

summary of care record when 

transitioning or referring their patient to 

another setting of care, retrieves a 

summary of care record upon the first 

patient encounter with a new patient, 

and incorporates summary of care 

information from other providers into 

their EHR using the functions of 

certified EHR technology. 

(B) Measures. In accordance with 

paragraph (a)(2) of this section, an EP 

must attest to all 3 measures, but must 

meet the threshold for 2 of the 3 

measures in paragraph (d)(6)(i)(B)(1), 

(2), and (3), in order to meet the 

objective. Subject to paragraph (c) of 

this section— 

(1) Measure 1. For more than 50 

percent of transitions of care and 

referrals, the EP that transitions or refers 

their patient to another setting of care or 

provider of care— 

(i) Creates a summary of care record 

using CEHRT; and 

(ii) Electronically exchanges the 

summary of care record. 

(2) Measure 2. For more than 40 

percent of transitions or referrals 

received and patient encounters in 

which the provider has never before 

encountered the patient, the EP 

incorporates into the patient’s EHR an 

electronic summary of care document 

from a source other than the provider’s 

EHR system. 

(3) Measure 3. For more than 80 

percent of transitions or referrals 

received and patient encounters in 

which the provider has never before 

encountered the patient, the EP 

performs clinical information 

reconciliation. The EP must implement 

clinical information reconciliation for 

the following three clinical information 

sets: 

(i) Medication. Review of the patient’s 

medication, including the name, dosage, 

frequency, and route of each 

medication. 

(ii) Medication allergy. Review of the 

patient’s known allergic medications. 

(iii) Current problem list. Review of 

the patient’s current and active 

diagnoses. 

(C) Exclusions in accordance with 

paragraph (a)(3) of this section. An EP 

must be excluded when any of the 

following occur: 

(1) An EP neither transfers a patient 

to another setting nor refers a patient to 

another provider during the EHR 

reporting period must be excluded from 

paragraph (d)(6)(i)(B)(1) of this section. 

(2) Any EP for whom the total of 

transitions or referrals recieved and 

patient encounters in which the 

provider has never before encountered 

the patient, is fewer than 100 during the 

EHR reporting period may be excluded 

from paragraphs (d)(6)(i)(B)(2) and 

(d)(6)(i)(B)(3) of this section. 

(3) 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 

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with 4Mbps broadband availability 

according to the latest information 

available from the FCC on the first day 

of the EHR reporting period may 

exclude from the measures specified in 

paragraphs (d)(6)(i)(B)(1), (B)(2) and 

(B)(3) of this section. 

(ii) Eligible hospitals and CAHs health 

information exchange. 

(A) Objective. The eligible hospital or 

CAH provides a summary of care record 

when transitioning or referring their 

patient to another setting of care, 

retrieves a summary of care record upon 

the first patient encounter with a their 

new patient, and incorporates summary 

of care information from other providers 

into EHR using the functions of certified 

EHR technology. 

(B) Measures. In accordance with 

paragraph (b)(2) of this section, an 

eligible hospital or CAH must attest to 

all three measures, but must meet the 

threshold for 2 of the 3 measures in 

paragraph (d)(6)(ii)(B)(1), (2), and (3). 

Subject to paragraph (c) of this section— 

(1) Measure 1. For more than 50 

percent of transitions of care and 

referrals, the eligible hospital or CAH 

that transitions or refers its patient to 

another setting of care or provider of 

care— 

(i) Creates a summary of care record 

using CEHRT; and 

(ii) Electronically exchanges the 

summary of care record. 

(2) Measure 2. For more than 40 

percent of transitions or referrals 

received and patient encounters in 

which the provider has never before 

encountered the patient, the eligible 

hospital or CAH incorporates into the 

patient’s EHR an electronic summary of 

care document from a source other than 

the provider’s EHR system. 

(3) Measure 3. For more than 80 

percent of transitions or referrals 

received and patient encounters in 

which the provider has never before 

encountered the patient, the eligible 

hospital or CAH performs a clinical 

information reconciliation. The provider 

must implement clinical information 

reconciliation for the following three 

clinical information sets: 

(i) Medication. Review of the patient’s 

medication, including the name, dosage, 

frequency, and route of each 

medication. 

(ii) Medication allergy. Review of the 

patient’s known allergic medications. 

(iii) Current problem list. Review of 

the patient’s current and active 

diagnoses. 

(C) Exclusions in accordance with 

paragraph (b)(3) of this section. 

(1) Any eligible hospital or CAH for 

whom the total of transitions or referrals 

recieved and patient encounters in 

which the provider has never before 

encountered the patient, is fewer than 

100 during the EHR reporting period 

may be excluded from paragraphs 

(d)(6)(i)(B)(2) and (d)(6)(i)(B)(3) of this 

section. 

(2) Any eligible hospital or CAH 

operating in a location 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 from the measures 

specified in paragraphs (d)(6)(ii)(B)(1), 

(2) and (3) of this section. 

(8) Public Health and Clinical Data 

Registry Reporting. 

(i) EP Public Health and Clinical Data 

Registry: Reporting objective. 

(A) Objective. The EP is in active 

engagement with a public health agency 

(PHA) or clinical data registry (CDR) to 

submit electronic public health data in 

a meaningful way using certified EHR 

technology, except where prohibited, 

and in accordance with applicable law 

and practice. 

(B) Measures. In order to meet the 

objective under paragraph (d)(8)(i)(A) of 

this section, an EP must choose from 

measures 1 through 5 (paragraphs 

(d)(8)(i)(B)(1) through (d)(8)(i)(B)(5) of 

this section) and must successfully 

attest to any combination of three 

measures. These measures may be met 

by any combination, including meeting 

measure specified in paragraph 

(d)(8)(i)(B)(4) or (5) of this section 

multiple times, in accordance with 

applicable law and practice: 

(1) Immunization registry reporting: 

The EP is in active engagement with a 

public health agency to submit 

immunization data and receive 

immunization forecasts and histories 

from the public health immunization 

registry/immunization information 

system (IIS). 

(2) Syndromic surveillance reporting. 

The EP is in active engagement with a 

public health agency to submit 

syndromic surveillance data from a nonurgent care ambulatory setting. 

(3) Case reporting. The EP is in active 

engagement with a public health agency 

to submit case reporting of reportable 

conditions. 

(4) Public health registry reporting. 

The EP is in active engagement with a 

public health agency to submit data to 

public health registries. 

(5) Clinical data registry reporting. 

The EP is in active engagement to 

submit data to a clinical data registry. 

(C) Exclusions in accordance with 

paragraph (a)(3) of this section. 

(1) Any EP meeting one or more of the 

following criteria may be excluded from 

the immunization registry reporting 

measure in paragraph (d)(8)(i)(B)(1) of 

this section if the EP: 

(i) Does not administer any 

immunizations to any of the 

populations for which data is collected 

by their jurisdiction’s immunization 

registry or immunization information 

system during the EHR reporting period. 

(ii) Operates in a jurisdiction for 

which no immunization registry or 

immunization information system is 

capable of accepting the specific 

standards required to meet the CEHRT 

definition at the start of its EHR 

reporting period. 

(iii) Operates in a jurisdiction where 

no immunization registry or 

immunization information system has 

declared readiness to receive 

immunization data at the start of the 

EHR reporting period. 

(2) Any EP meeting one or more of the 

following criteria may be excluded from 

the syndromic surveillance reporting 

measure described in paragraph 

(d)(8)(i)(B)(2) of the section if the EP: 

(i) Does not treat or diagnose or 

directly treat any disease or condition 

associated with a syndromic 

surveillance system in the EP’s 

jurisdiction. 

(ii) Operates in a jurisdiction for 

which no public health agency is 

capable of receiving electronic 

syndromic surveillance data in the 

specific standards required to meet the 

CEHRT definition at the start of the EHR 

reporting period. 

(iii) Operates in a jurisdiction where 

no public health agency has declared 

readiness to receive syndromic 

surveillance data at the start of the EHR 

reporting period. 

(3) Any EP meeting one or more of the 

following criteria may be excluded from 

the case reporting measure at paragraph 

(d)(8)(i)(B)(3) of this section if the EP: 

(i) Does not treat or diagnose any 

reportable diseases for which data is 

collected by their jurisdiction’s 

reportable disease system during the 

EHR reporting period. 

(ii) Operates in a jurisdiction for 

which no public health agency is 

capable of receiving electronic case 

reporting data in the specific standards 

required to meet the CEHRT definition 

at the start of the EHR reporting period. 

(iii) Operates in a jurisdiction where 

no public health agency has declared 

readiness to receive electronic case 

reporting data at the start of the EHR 

reporting period. 

(4) Any EP meeting at least one of the 

following criteria may be excluded from 

the public health registry reporting 

measure specified in paragraph 

(d)(8)(i)(B)(4) of this section if the EP: 

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(i) Does not diagnose or directly treat 

any disease or condition associated with 

a public health registry in the EP’s 

jurisdiction during the EHR reporting 

period. 

(ii) Operates in a jurisdiction for 

which no public health agency is 

capable of accepting electronic registry 

transactions in the specific standards 

required to meet the CEHRT definition 

at the start of the EHR reporting period. 

(iii) Operates in a jurisdiction where 

no public health registry for which the 

EP is eligible has declared readiness to 

receive electronic registry transactions 

at the beginning of the EHR reporting 

period. 

(5) Any EP meeting at least one of the 

following criteria may be excluded from 

the clinical data registry reporting 

measure specified in paragraph 

(d)(8)(i)(B)(5) of this section if the EP: 

(i) Does not diagnose or directly treat 

any disease or condition associated with 

a clinical data registry in their 

jurisdiction during the EHR reporting 

period; 

(ii) Operates in a jurisdiction for 

which no clinical data registry is 

capable of accepting electronic registry 

transactions in the the specific 

standards required to meet the CEHRT 

definition at the start of the EHR 

reporting period. 

(iii) Operates in a jurisdiction where 

no clinical data registry for which the 

EP is eligible has declared readiness to 

receive electronic registry transactions 

at the beginning of the EHR reporting 

period. 

(ii) Eligible hospital and CAH Public 

Health and Clinical Data Registry: 

Reporting objective. 

(A) Objective. The eligible hospital or 

CAH is in active engagement with a 

public health agency (PHA) or clinical 

data registry (CDR) to submit electronic 

public health data in a meaningful way 

using certified EHR technology, except 

where prohibited, and in accordance 

with applicable law and practice. 

(B) Measures. In order to meet the 

objective under paragraph (d)(8)(ii)(A) 

of this section, an eligible hospital or 

CAH must choose from measures 1 

through 6 (as described in paragraphs 

(d)(8)(ii)(B)(1) through (d)(8)(ii)(B)(6) of 

this section) and must successfully 

attest to any combination of four 

measures. These measures may be met 

by any combination, including meeting 

the measure specified in paragraph 

(d)(8)(ii)(B)(4) or (5) of this section 

multiple times, in accordance with 

applicable law and practice: 

(1) Immunization registry reporting. 

The eligible hospital or CAH is in active 

engagement with a public health agency 

to submit immunization data and 

receive immunization forecasts and 

histories from the public health 

immunization registry/immunization 

information system (IIS). 

(2) Syndromic surveillance reporting. 

The eligible hospital or CAH is in active 

engagement with a public health agency 

to submit syndromic surveillance data 

from an emergency or urgent care 

department (POS 23). 

(3) Case reporting. The eligible 

hospital or CAH is in active engagement 

with a public health agency to submit 

case reporting of reportable conditions. 

(4) Public health registry reporting. 

The eligible hospital or CAH is in active 

engagement with a public health agency 

to submit data to public health 

registries. 

(5) Clinical data registry reporting. 

The eligible hospital or CAH is in active 

engagement to submit data to a clinical 

data registry. 

(6) Electronic reportable laboratory 

result reporting. The eligible hospital or 

CAH is in active engagement with a 

public health agency to submit 

electronic reportable laboratory results. 

(C) Exclusions in accordance with 

paragraph (b)(3) of this section. 

(1) Any eligible hospital or CAH 

meeting one or more of the following 

criteria may be excluded from to the 

immunization registry reporting 

measure specified in paragraph 

(d)(8)(ii)(B)(1) of this section if the 

eligible hospital or CAH: 

(i) Does not administer any 

immunizations to any of the 

populations for which data is collected 

by its jurisdiction’s immunization 

registry or immunization information 

system during the EHR reporting period. 

(ii) Operates in a jurisdiction for 

which no immunization registry or 

immunization information system is 

capable of accepting the specific 

standards required to meet the CEHRT 

definition at the start of the EHR 

reporting period. 

(iii) Operates in a jurisdiction where 

no immunization registry or 

immunization information system has 

declared readiness to receive 

immunization data at the start of the 

EHR reporting period. 

(2) Any eligible hospital or CAH 

meeting one or more of the following 

criteria may be excluded from the 

syndromic surveillance reporting 

measure specified in paragraph 

(d)(8)(ii)(B)(2) of this section if the 

eligible hospital or CAH: 

(i) Does not have an emergency or 

urgent care department. 

(ii) Operates in a jurisdiction for 

which no public health agency is 

capable of receiving electronic 

syndromic surveillance data in the 

specific standards required to meet the 

CEHRT definition at the start of the EHR 

reporting period. 

(iii) Operates in a jurisdiction where 

no public health agency has declared 

readiness to receive syndromic 

surveillance data at the start of the EHR 

reporting period. 

(3) Any eligible hospital or CAH 

meeting one or more of the following 

criteria may be excluded from the case 

reporting measure specified in 

paragraph (d)(8)(ii)(B)(3) of this section 

if the eligible hospital or CAH: 

(i) Does not treat or diagnose any 

reportable diseases for which data is 

collected by their jurisdiction’s 

reportable disease system during the 

EHR reporting period. 

(ii) Operates in a jurisdiction for 

which no public health agency is 

capable of receiving electronic case 

reporting data in the specific standards 

required to meet the CEHRT definition 

at the start of their EHR reporting 

period. 

(iii) Operates in a jurisdiction where 

no public health agency has declared 

readiness to receive electronic case 

reporting data at the start of the EHR 

reporting period. 

(4) Any eligible hospital or CAH 

meeting at least one of the following 

criteria may be excluded from the 

public health registry reporting measure 

specified in paragraph (d)(8)(ii)(B)(4) of 

this section if the eligible hospital or 

CAH: 

(i) Does not diagnose or directly treat 

any disease or condition associated with 

a public health registry in its 

jurisdiction during the EHR reporting 

period. 

(ii) Operates in a jurisdiction for 

which no public health agency is 

capable of accepting electronic registry 

transactions in the specific standards 

required to meet the CEHRT definition 

at the start of the EHR reporting period. 

(iii) Operates in a jurisdiction where 

no public health registry for which the 

eligible hospital or CAH is eligible has 

declared readiness to receive electronic 

registry transactions at the beginning of 

the EHR reporting period. 

(5) Any eligible hospital or CAH 

meeting at least one of the following 

criteria may be excluded from the 

clinical data registry reporting measure 

specified in paragraph (d)(8)(ii)(B)(5) of 

this section if the eligible hospital or 

CAH: 

(i) Does not diagnose or directly treat 

any disease or condition associated with 

a clinical data registry in their 

jurisdiction during the EHR reporting 

period. 

(ii) Operates in a jurisdiction for 

which no clinical data registry is 

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Federal Register / Vol. 80, No. 60 / Monday, March 30, 2015 / Proposed Rules 16803 

capable of accepting electronic registry 

transactions in the specific standards 

required to meet the CEHRT definition 

at the start of the EHR reporting period. 

(iii) Operates in a jurisdiction where 

no clinical data registry for which the 

eligible hospital or CAH is eligible has 

declared readiness to receive electronic 

registry transactions at the beginning of 

the EHR reporting period. 

(6) Any eligible hospital or CAH 

meeting one or more of the following 

criteria may be excluded from the 

electronic reportable laboratory result 

reporting measure specified in 

paragraph (d)(8)(ii)(B)(6) of this section 

if the eligible hospital or CAH: 

(i) Does not perform or order 

laboratory tests that are reportable in its 

jurisdiction during the EHR reporting 

period. 

(ii) Operates in a jurisdiction for 

which no public health agency that is 

capable of accepting the specific ELR 

standards required to meet the CEHRT 

definition at the start of the EHR 

reporting period. 

(iii) Operates in a jurisdiction where 

no public health agency has declared 

readiness to receive electronic 

reportable laboratory results at the start 

of the EHR reporting period. 

■ 5. Section 495.8 is amended as 

follows: 

■ A. In paragraph (a) introductory text, 

by removing the cross-reference ‘‘under 

§ 495.6 of this subpart’’ and adding in 

its place the cross-reference ‘‘under 

§ 495.6 or § 495.7’’. 

■ B. In paragraph (a)(1)(i)(B), by 

removing the cross-reference ‘‘under 

§ 495.6(d) and § 495.6(e) of this subpart’’ 

and adding in its place the crossreference ‘‘under § 495.6 or § 495.7’’. 

■ C. In paragraph (a)(1)(iii), by removing 

the cross-reference ‘‘in § 495.6 and 

§ 495.8 of this subpart’’ and adding in 

its place the cross-reference ‘‘in § 495.6 

or § 495.7 and § 495.8’’. 

■ D. In paragraph (a)(2)(i)(B), by 

removing the cross-reference ‘‘under 

§ 495.6’’ and adding in its place the 

cross-reference ‘‘under § 495.6 or 

§ 495.7’’. 

■ E. Adding paragraph (a)(2)(i)(E). 

■ F. In paragraph (a)(2)(iv), by removing 

the cross-reference ‘‘in § 495.6 and 

§ 495.8 of this subpart’’ and adding in 

its place the cross-reference ‘‘in § 495.6 

or § 495.7 and § 495.8’’. 

■ G. In paragraph (b)(1)(i)(B), by 

removing the cross-reference ‘‘under 

§ 495.6(f) and § 495.6(g)’’ and adding in 

its place the cross-reference ‘‘under 

§ 495.6 or § 495.7’’. 

■ H. Redesignating paragraph (b)(1)(iv) 

and paragraph (b)(1)(iii). 

■ I. In newly redesignated paragraph 

(b)(1)(iii), by removing the crossreference ‘‘in § 495.6 and § 495.8 of this 

subpart’’ and adding in its place the 

cross-reference ‘‘in § 495.6 or § 495.7 

and § 495.8’’. 

■ J. In paragraph (b)(2)(i)(B), by 

removing the cross-reference ‘‘under 

§ 495.6’’ and adding in its place the 

cross-reference ‘‘under § 495.6 or 

§ 495.7’’. 

■ K. Adding paragraph (b)(2)(i)(E). 

The additions read as follows: 

§ 495.8 Demonstration of meaningful use 

criteria. 

(a) * * * 

(2) * * * 

(i) * * * 

(E) For 2017 only, an EP may attest to 

the following: 

(1) Stage 1 objectives and measures 

outlined at § 495.6 if the EP has never 

before demonstrated meaningful use, or 

if the EP previously demonstrated 

meaningful use for the first time in 2015 

or 2016. 

(2) Stage 2 objectives and measures 

outlined at § 495.6 if the EP previously 

demonstrated meaningful use for any 

year prior to 2017. 

(3) Stage 3 objectives and measures 

outlined at § 495.7 if the EP has never 

before demonstrated meaningful use or 

if the EP has demonstrated meaningful 

use for any year prior to 2017. 

* * * * * 

(b) * * * 

(2) * * * 

(i) * * * 

(E) For 2017 only, an eligible hospital 

or CAH may attest to the following: 

(1) Stage 1 objectives and measures 

outlined at § 495.6 if the eligible 

hospital or CAH has never before 

demonstrated meaningful use, or if the 

eligible hospital or CAH previously 

demonstrated meaningful use for the 

first time in 2015 or 2016. 

(2) Stage 2 objectives and measures 

outlined at § 495.6 if the eligible 

hospital or CAH previously 

demonstrated meaningful use for any 

year prior to 2017. 

(3) Stage 3 objectives and measures 

outlined at § 495.7 if the eligible 

hospital or CAH has never before 

demonstrated meaningful use or if the 

eligible hospital or CAH has 

demonstrated meaningful use for any 

year prior to 2017. 

* * * * * 

■ 6. Section 495.316 is amended by 

revising paragraph (c) introductory text 

and adding paragraphs (d)(2)(iii), (f), (g), 

and (h) to read as follows: 

§ 495.316 State monitoring and reporting 

regarding activities required to receive an 

incentive payment. 

* * * * * 

(c) Subject to § 495.332 and § 495.352, 

the State is required to submit to CMS 

annual reports, in the manner 

prescribed by CMS, on the following: 

* * * * * 

(d) * * * 

(2) * * * 

(iii) Subject to § 495.332, the State 

may propose a revised definition for 

Stage 3 of meaningful use of certified 

EHR technology, subject to CMS prior 

approval, but only with respect to the 

public health and clinical data registry 

reporting objective described in 

§ 495.7(d)(8). 

* * * * * 

(f) Each State must submit to CMS the 

annual report described in paragraph (c) 

of this section within 45 days of the end 

of the second quarter of the Federal 

fiscal year. 

(g) The State must, on a quarterly 

basis and in the manner prescribed by 

CMS, submit a report(s) on the 

following: 

(1) The State and payment year to 

which the quarterly report pertains. 

(2) Subject to paragraph (h)(2) of this 

section, provider-level attestation data 

for each EP and eligible hospital that 

attests to demonstrating meaningful use 

for each payment year beginning with 

2013. 

(h)(1) Subject to paragraph (h)(2) of 

this section, the quarterly report 

described in paragraph (g) of this 

section must include the following for 

each EP and eligible hospital: 

(i) The payment year number. 

(ii) The provider’s National Provider 

Identifier or CCN, as appropriate. 

(iii) Attestation submission date. 

(iv) The state qualification. 

(v) The state qualification date, which 

is the beginning date of the provider’s 

EHR reporting period for which it 

demonstrated meaningful use. 

(vi) The State disqualification, if 

applicable. 

(vii) The State disqualification date, 

which is the beginning date of the 

provider’s EHR reporting period to 

which the provider attested but for 

which it did not demonstrate 

meaningful use, if applicable. 

(2) The quarterly report described in 

paragraph (g) of this section is not 

required to include information on EPs 

who are eligible for the Medicaid EHR 

incentive program on the basis of being 

a nurse practitioner, certified nursemidwife or physician assistant. 

■ 7. Section 495.352 is revised to read 

as follows: 

§ 495.352 Reporting requirements. 

(a) Each State must submit to HHS on 

a quarterly basis a progress report, in the 

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16804 Federal Register / Vol. 80, No. 60 / Monday, March 30, 2015 / Proposed Rules 

manner prescribed by HHS, 

documenting specific implementation 

and oversight activities performed 

during the quarter, including progress in 

implementing the State’s approved 

Medicaid HIT plan. 

(b) The quarterly progress reports 

must include, but need not be limited to 

providing, updates on the following: 

(1) State system implementation 

dates. 

(2) Provider outreach. 

(3) Auditing. 

(4) State-specific State Medicaid HIT 

Plan tasks. 

(5) State staffing levels and changes. 

(6) The number and type of providers 

that qualified for an incentive payment 

on the basis of having adopted, 

implemented or upgraded certified EHR 

technology and the amounts of 

incentive payments. 

(7) The number and type of providers 

that qualified for an incentive payment 

on the basis of having demonstrated that 

they are meaningful users of certified 

EHR technology and the amounts of 

incentive payments. 

Dated: March 10, 2015. 

Andrew M. Slavitt, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: March 18, 2015. 

Sylvia M. Burwell, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2015–06685 Filed 3–20–15; 3:00 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

45 CFR Part 170 

RIN 0991–AB93 

2015 Edition Health Information 

Technology (Health IT) Certification 

Criteria, 2015 Edition Base Electronic 

Health Record (EHR) Definition, and 

ONC Health IT Certification Program 

Modifications 

AGENCY: Office of the National 

Coordinator for Health Information 

Technology (ONC), Department of 

Health and Human Services (HHS). 

ACTION: Notice of proposed rulemaking 

with comment period. 

SUMMARY: This notice of proposed 

rulemaking introduces a new edition of 

certification criteria (the 2015 Edition 

health IT certification criteria or ‘‘2015 

Edition’’), proposes a new 2015 Edition 

Base EHR definition, and proposes to 

modify the ONC Health IT Certification 

Program to make it open and accessible 

to more types of health IT and health IT 

that supports various care and practice 

settings. The 2015 Edition would also 

establish the capabilities and specify the 

related standards and implementation 

specifications that Certified Electronic 

Health Record (EHR) Technology 

(CEHRT) would need to include to, at a 

minimum, support the achievement of 

meaningful use by eligible professionals 

(EPs), eligible hospitals, and critical 

access hospitals (CAHs) under the 

Medicare and Medicaid EHR Incentive 

Programs (EHR Incentive Programs) 

when such edition is required for use 

under these programs. 

DATES: To be assured consideration, 

written or electronic comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

May 29, 2015. 

ADDRESSES: You may submit comments, 

identified by RIN 0991–AB93, by any of 

the following methods (please do not 

submit duplicate comments). Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

• Federal eRulemaking Portal: Follow 

the instructions for submitting 

comments. Attachments should be in 

Microsoft Word, Microsoft Excel, or 

Adobe PDF; however, we prefer 

Microsoft Word. http://

www.regulations.gov. 

• Regular, Express, or Overnight Mail: 

Department of Health and Human 

Services, Office of the National 

Coordinator for Health Information 

Technology, Attention: 2015 Edition 

Health IT Certification Criteria Proposed 

Rule, Hubert H. Humphrey Building, 

Suite 729D, 200 Independence Ave SW., 

Washington, DC 20201. Please submit 

one original and two copies. 

• Hand Delivery or Courier: Office of 

the National Coordinator for Health 

Information Technology, Attention: 

2015 Edition Health IT Certification 

Criteria Proposed Rule, Hubert H. 

Humphrey Building, Suite 729D, 200 

Independence Ave SW., Washington, 

DC 20201. Please submit one original 

and two copies. (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 mail drop slots located in the main 

lobby of the building.) 

Enhancing the Public Comment 

Experience: To facilitate public 

comment on this proposed rule, a copy 

will be made available in Microsoft 

Word format. We believe this version 

will make it easier for commenters to 

access and copy portions of the 

proposed rule for use in their individual 

comments. Additionally, a separate 

document will be made available for the 

public to use to provide comments on 

the proposed rule. This document is 

meant to provide the public with a 

simple and organized way to submit 

comments on the certification criteria, 

associated standards and 

implementation specifications, and 

respond to specific questions posed in 

the preamble of the proposed rule. 

While use of this document is entirely 

voluntary, we encourage commenters to 

consider using the document in lieu of 

unstructured comments or to use it as 

an addendum to narrative cover pages. 

Roughly 30% of the public comments 

submitted to our past two editions of 

certification criteria proposed rules used 

the provided template, which greatly 

assisted in our ability to rapidly process 

and more accurately categorize public 

comments. Because of the technical 

nature of this proposed rule, we believe 

that use of the document may facilitate 

our review and understanding of the 

comments received. The Microsoft 

Word version of the proposed rule and 

the document that can be used for 

providing comments can be found at 

http://www.regulations.gov as part of 

this proposed rule’s docket and on 

ONC’s Web site (http://

www.healthit.gov). 

Inspection of Public Comments: All 

comments received before the close of 

the comment period will be available for 

public inspection, including any 

personally identifiable or confidential 

business information that is included in 

a comment. Please do not include 

anything in your comment submission 

that you do not wish to share with the 

general public. Such information 

includes, but is not limited to: a 

person’s social security number; date of 

birth; driver’s license number; state 

identification number or foreign country 

equivalent; passport number; financial 

account number; credit or debit card 

number; any personal health 

information; or any business 

information that could be considered 

proprietary. We will post all comments 

that are received before the close of the 

comment period at http://

www.regulations.gov. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov or the Department 

of Health and Human Services, Office of 

the National Coordinator for Health 

Information Technology, Hubert H. 

Humphrey Building, Suite 729D, 200 

Independence Ave SW., Washington, 

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