20346 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 495 

[CMS–3311–P] 

RIN 0938–AS58 

Medicare and Medicaid Programs; 

Electronic Health Record Incentive 

Program—Modifications to Meaningful 

Use in 2015 Through 2017 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

change the Medicare and Medicaid 

Electronic Health Record (EHR) 

Incentive Program EHR reporting period 

in 2015 to a 90-day period aligned with 

the calendar year, and also would align 

the EHR reporting period in 2016 with 

the calendar year. In addition, this 

proposed rule would modify the patient 

action measures in the Stage 2 

objectives related to patient engagement. 

Finally, it would streamline the program 

by removing reporting requirements on 

measures which have become 

redundant, duplicative, or topped out 

through advancements in EHR function 

and provider performance for Stage 1 

and Stage 2 of the Medicare and 

Medicaid EHR Incentive Programs. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on June 15, 2015. 

ADDRESSES: In commenting, please refer 

to file code CMS–3311–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– 

3311–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– 

3311–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. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http://

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

Acronyms 

ARRA—American Recovery and 

Reinvestment Act of 2009 

AAC—Average Allowable Cost (of certified 

EHR Technology) 

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 

ePHI—Electronic Protected Health 

Information 

EPO—Exclusive Provider Organization 

FACA—Federal Advisory Committee Act 

FFP—Federal Financial Participation 

FFY—Federal Fiscal Year 

FFS—Fee-for-Service 

FQHC—Federally Qualified Health Center 

FTE—Full Time Equivalent 

FY—Fiscal Year 

HEDIS—Healthcare Effectiveness Data and 

Information Set 

HHS—Department of Health and Human 

Services 

HIE—Health Information Exchange 

HIT—Health Information Technology 

HITPC—Health Information Technology 

Policy Committee 

HIPAA—Health Insurance Portability and 

Accountability Act of 1996 

HITECH—Health Information Technology for 

Economic and Clinical Health Act 

HMO—Health Maintenance Organization 

HOS—Health Outcomes Survey 

HPSA—Health Professional Shortage Area 

HRSA—Health 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 

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Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 20347 

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 would 

implement changes to Stage 1 and Stage 

2 of the Medicare and Medicaid EHR 

Incentive Programs. In the March 30, 

2015 Federal Register (80 FR 16731 

through 16804), we published in the 

proposed rule for Stage 3 of meaningful 

use which included changes to the 

objectives and measures of meaningful 

use for providers beginning in 2017. 

These changes included removing 

redundant, duplicative, and topped out 

measures, and focusing the EHR 

Incentive Programs on advanced use of 

EHR technology. In order to reduce 

reporting burden, eliminate redundant 

and duplicative reporting, and to better 

align the objectives and measures of 

meaningful use for 2015 through 2017 

with the proposed Stage 3 requirements 

which would be optional in 2017 and 

required beginning in 2018, we are 

proposing to make similar modifications 

to Stage 1 and Stage 2 of the EHR 

Incentive Programs. 

In addition, in order to accommodate 

these changes, we propose additional 

modifications to the EHR reporting 

period and timeline of the Medicare and 

Medicaid EHR Incentive Programs in 

2015 and 2016. We believe these 

changes would better align reporting 

periods for providers, support a flexible, 

clear framework to reduce provider 

burden, and ensure future sustainability 

of the Medicare and Medicaid EHR 

Incentive Programs. 

b. Legal Authority for the Regulatory 

Action 

The American Recovery and 

Reinvestment Act of 2009 (ARRA) (Pub. 

L. 111–5) amended Titles XVIII and XIX 

of the Social Security Act (the Act) to 

authorize incentive payments to Eligible 

Professionals (EPs), eligible hospitals, 

and Critical Access Hospitals (CAHs), 

and Medicare Advantage (MA) 

organizations to promote the adoption 

and meaningful use of Certified 

Electronic Health Record 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 

CAHs respectively. Sections 1848(a)(7), 

1853(l) and (m), 1886(b)(3)(B), and 

1814(l) of the Act also establish 

downward payment adjustments, 

beginning with calendar or fiscal year 

2015, for EPs, MA organizations, 

subsection (d) hospitals, and CAHs that 

are not meaningful users of CEHRT for 

certain associated reporting periods. 

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

Act provide the statutory basis for 

Medicaid incentive payments. (There 

are no payment adjustments under 

Medicaid). (For a more detailed 

explanation of the statutory basis for the 

EHR incentive payments, see the July 

28, 2010 Stage 1 final rule (75 FR 44316 

through 44317).) 

2. Summary of Major Provisions 

a. Aligning Meaningful Use in 2015 

Through 2017 With the Stage 3 

Proposals for 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 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 the 

objectives and measures of Stage 1, we 

refer readers to the Stage 1 final rule at 

75 FR 44313 through 44588.) In the 

Stage 1 rulemaking, we discussed the 

idea that alignment of stage of 

meaningful use and payment year 

should synchronize for all providers in 

2015. However, while we stated a goal 

to align the stages of meaningful use 

across all providers in 2015 (75 FR 

44322), we did not finalize such 

changes in the Stage 2 final rule. 

Furthermore, we stated in subsequent 

rulemaking (see for example the 2014 

CERHT Flexibility rule at 79 FR 52923 

and 52596) that the requirements for 

each stage for the program must be 

informed by analysis of program data 

related to performance and participation 

milestones. 

In the September 4, 2012 stage 2 final 

rule, we maintained the same coremenu structure finalized for several 

Stage 1 core and menu objectives. We 

finalized that EPs must meet the 

measure 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 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. Also, 

beginning in 2014, we finalized a set of 

clinical quality measures (CQMs) for all 

providers participating in any Stage of 

the program to report to CMS. (For a full 

discussion of the meaningful use 

objectives and measures, and the CQMs 

we finalized under Stage 2, we refer 

readers to the Stage 2 final rule at 77 FR 

53968 through 54162.) 

In the Stage 3 proposed rule, we built 

on the groundwork established in the 

Stage 1 and Stage 2 final rules, 

including continuing our goal started 

under Stage 2 to increase 

interoperability among providers. We 

also proposed to make changes to the 

Medicare and Medicaid EHR Incentive 

Programs that simplify reporting 

requirements and reduce program 

complexity. These changes were 

intended to balance the statutory 

requirements in the HITECH Act with 

responsiveness to providers expressing 

confusion and concerns over increased 

reporting burden related to the number 

of program requirements, the multiple 

stages of program participation, and the 

timing of EHR reporting periods. 

Therefore, we proposed for Stage 3 a 

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20348 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 

single set of 8 objectives and related 

measures to meet the definition of 

meaningful use. We proposed that this 

single set of 8 objectives would be 

optional for 2017 and mandatory 

beginning in 2018. Also, the Stage 3 

proposed rule would move all providers 

to an EHR reporting period of one full 

calendar year, with a limited exception 

for Medicaid providers demonstrating 

meaningful use for the first time, to 

support program alignment and simplify 

reporting requirements among provider 

types. The Stage 3 proposed rule and 

the 2015 Edition 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 by the Office of the National 

Coordinator for Health Information 

Technology (ONC) may be reviewed at 

80 FR 16731 through 16804 and 80 FR 

16804 through 1692, respectively. The 

Stage 3 proposed rule would align the 

stages of meaningful use across all 

providers beginning in 2018. 

In this proposed rule, we are seeking 

to make changes to the requirements for 

Stage 1 and Stage 2 of meaningful use 

for 2015 through 2017 to align with the 

approach for Stage 3 of meaningful use 

in 2017 and subsequent years. The 

analysis conducted during the planning 

process for Stage 3 also allowed insight 

into the progress toward program 

milestones and provider performance on 

the objectives and measures. This 

analysis allowed us to identify an 

approach to be responsive to 

stakeholder concerns about program 

complexity and revisit the consideration 

that the stage of meaningful use and 

EHR reporting periods should align 

where possible. Therefore, we are 

proposing a number of changes to both 

the EHR reporting period, and to the 

number of objectives and measures to 

which a provider must attest to 

demonstrate meaningful use. 

Specifically, we are proposing to move 

all providers to an EHR reporting period 

based on the calendar year beginning in 

2015. Also, we propose to align the 

objectives and measures used in 2015 

through 2017 with those identified in 

the Stage 3 proposed rule for use in 

2017 and subsequent years. This 

includes a proposal that, beginning with 

an EHR reporting period in 2015, 

providers would no longer be required 

to attest to certain objectives and 

measures which have been identified 

through our analysis to have reduced 

utility because they may now be 

redundant, duplicative, or ‘‘topped 

out’’. (For further discussion of this 

selection process for Stage 3, we direct 

readers to sections I.A.2. and II.A.2. of 

the Stage 3 proposed rule at (80 FR 

16733 through 16735 and 16767 through 

16768, respectively). The related 

selection process for the proposed 

changes to meaningful use in 2015 

through 2017 uses a similar approach to 

reducing the reporting burden while 

also seeking to meet our statutory 

requirement to include more stringent 

measures of meaningful use. Our 

approach for applying these principals 

for meaningful use in 2015 through 

2017 is discussed in more detail in 

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

b. EHR Reporting Period in 2015 and 

2016 

We are proposing to align the 

definition of an EHR reporting period 

with the calendar year for all providers 

beginning in 2015 and continuing 

through 2016 onward. Specifically, this 

proposal would change the EHR 

reporting period for eligible hospitals 

and CAHs from a period based on the 

fiscal year to the calendar year 

beginning in 2015. This aligns with the 

provision outlined in the Stage 3 

proposed rule to move all providers to 

an EHR reporting period of 1 full 

calendar year beginning in 2017 with a 

limited exception for Medicaid 

providers demonstrating meaningful use 

for the first time (80 FR 16734 and 80 

FR 16737 through 16739). For 2015 and 

2016, we are proposing to allow new 

participants in the EHR Incentive 

Program to attest to meaningful use for 

an EHR reporting period of any 

continuous 90-day period within the 

calendar year. In addition, for 2015 

only, we are proposing to allow all EPs 

(regardless of their prior participation in 

the program) to attest to an EHR 

reporting period of any continuous 90- 

day period within the calendar year. For 

2015 only, we are proposing to allow 

eligible hospitals and CAHs (regardless 

of their prior participation in the 

program) to attest to an EHR reporting 

period of any continuous 90-day period 

within the period beginning October 1, 

2014 and the close of the 2015 calendar 

year. This 90-day EHR reporting period 

for 2015 would allow providers 

additional time to address any 

remaining issues with the 

implementation of technology certified 

to the 2014 Edition and to accommodate 

the changes to the objectives and 

measures of meaningful use proposed in 

this rule. 

In 2016, we propose EPs, eligible 

hospitals, and CAHs that are 

demonstrating meaningful use for the 

first time may use an EHR reporting 

period of any continuous 90-day period 

between January 1, 2016 and December 

31, 2016. However, all returning 

participants would use an EHR 

reporting period of a full calendar year 

from January 1, 2016 through December 

31, 2016. In 2017, all providers, both 

new and existing participants, would 

use an EHR reporting period of 1 full 

calendar year as proposed in the Stage 

3 proposed rule at (80 FR 16737 through 

16739) with a limited exception for 

Medicaid providers demonstrating 

meaningful use for the first time. 

c. Meaningful Use Objectives and 

Measures for 2015 Through 2017 

In the Stage 3 proposed rule, we 

outlined our method and approach for 

identifying the objectives and measures 

retained for Stage 3 of meaningful use 

in 2017. We also identified those 

objectives and measures which are now 

redundant, duplicative, or topped out; 

and therefore; would no longer be 

required for the successful 

demonstration of meaningful use for 

Stage 3. For further discussion of this 

approach, we refer readers to (80 FR 

16733 through 16735 and 16767 through 

16768). 

In this proposed rule, we discuss how 

we have used the same method to 

identify objectives and measures from 

Stages 1 and 2 of meaningful use which 

we believe should no longer be required 

for a provider to demonstrate 

meaningful use in 2015 through 2017 as 

these measures have been identified as 

redundant, duplicative, or topped out. 

These changes would remove the menu 

and core structure of Stages 1 and 2 and 

reduce the overall number of objectives 

to which a provider must attest. We 

discuss this approach in section II.B.1.c. 

of this proposed rule. 

In addition, we are proposing changes 

to individual objectives and measures 

for Stage 2 of meaningful use as follows: 

• Changing the threshold from the 

Stage 2 Objective for Patient Electronic 

Access measure number 2 from ‘‘5 

percent’’ to ‘‘equal to or greater than 1’’. 

• Changing the threshold from the 

Stage 2 Objective Secure Electronic 

Messaging from being a percentagebased measure, to yes-no measure 

stating the ‘‘functionality fully 

enabled’’. 

• Consolidating all public health 

reporting objectives into one objective 

with measure options following the 

structure of the Stage 3 Public Health 

Reporting Objective (80 FR 16745 

through 16767). 

• Changing the eligible hospital 

electronic prescribing objective from a 

‘‘menu’’ objective to a mandatory 

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Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 20349 

objective with an exclusion available for 

certain eligible hospitals and CAHs. 

These proposed changes would apply 

for providers beginning with the EHR 

reporting period in 2015. We note that 

these proposals include provisions to 

maintain the existing definitions for the 

objectives and measures including 

numerator and denominator calculation, 

provisions to maintain measure 

thresholds for 2015, and provisions to 

allow exclusions for certain eligible 

providers in 2015 in order to facilitate 

the transition for providers already 

engaged in the workflows, data capture 

and measure calculation for meaningful 

use for an EHR reporting period in 2015. 

d. Certification Requirements 

Under this proposed rule, we are not 

proposing changes to the individual 

certification requirements for the 

objectives and measures of meaningful 

use for an EHR reporting period in 2015 

through 2017. Until a transition to EHR 

technology certified to the 2015 Edition 

is required (proposed in the Stage 3 

proposed rule beginning with an EHR 

reporting period in 2018 at (80 FR 16767 

and 16768), we are proposing that 

providers would continue to use EHR 

technology certified to the 2014 Edition 

for an EHR reporting period in 2015, 

2016, and 2017. As outlined in the Stage 

3 proposed rule, providers may upgrade 

early to EHR technology certified to the 

2015 Edition for an EHR reporting 

period prior to 2018. (For further 

information on this, and to review the 

applicable definition of CEHRT, we 

direct readers to the Stage 3 proposed 

rule at (80 FR 16767 and 16768). 

e. Medicaid EHR Incentive Program in 

2015 through 2017 

The proposals included in this 

proposed rule would also apply for the 

Medicaid EHR Incentive Program, 

including the proposed changes to the 

EHR reporting period in 2015 and 2016, 

and the objectives and measures 

required to demonstrate meaningful use 

in 2015 through 2017. Consistent with 

the Stage 3 proposed rule, we propose 

to continue to offer states flexibility 

under the Medicaid EHR Incentive 

Program for the public health reporting 

objective. For meaningful use in 2015 

through 2017, we would continue the 

policy stated in the Stage 2 final rule (77 

FR 53979) to allow states to specify the 

means of transmission of the data or 

otherwise change the public health 

measure (as long as it does not require 

EHR functionality above and beyond 

that which is included in the 

certification requirements specified 

under the 2014 Edition certification 

criteria). (For more information see the 

Stage 3 proposed rule (80 FR 16737 

through 16739).) 

f. Clinical Quality Measurement 

We are not proposing changes to the 

CQM selection or reporting scheme (9 or 

16 CQMs across at least 3 domains) from 

the CQM requirements previously 

established for all providers seeking to 

demonstrate meaningful use in the 

Medicare and Medicaid EHR Incentive 

Programs defined in earlier rulemaking 

(see, for example, 77 FR 54049 through 

54089). For an EHR reporting period in 

2015, and for providers demonstrating 

meaningful use for the first time in 

2016, we are proposing that providers 

may— 

• Attest to any continuous 90-day 

period of CQM data during the calendar 

year through the Medicare EHR 

Incentive Program registration and 

attestation site; or 

• Electronically report CQM data 

using the established methods for 

electronic reporting. 

For 2016 and subsequent years, 

providers beyond their first year of 

meaningful use may attest to one full 

calendar year of CQM data or they may 

electronically report their CQM data 

using the established methods for 

electronic reporting outlined in section 

II.C. of this proposed rule. 

g. Demonstration of Meaningful Use 

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 states for use in their 

Medicaid programs. We are proposing to 

continue the use of attestation as the 

method for demonstrating that an EP, 

eligible hospital, or CAH has met the 

objectives and measures of meaningful 

use. In lieu of individual Medicare EP 

attestation through the CMS registration 

and attestation system, we are proposing 

to continue the existing optional batch 

file process for attestation. We are 

additionally proposing changes to the 

attestation deadlines to accommodate 

the proposed change to reporting based 

on the calendar year for eligible 

hospitals and CAHs beginning with an 

EHR reporting period in 2015, as well as 

the proposed change to a 90-day EHR 

reporting period for all providers in 

2015. We are proposing changes to the 

attestation deadlines for new 

meaningful EHR users in 2015 and 2016 

to avoid the Medicare payment 

adjustments in 2016 and 2017. Finally, 

we are proposing an alternate attestation 

option for certain Medicaid providers to 

demonstrate meaningful use in 2015 

and subsequent years to avoid Medicare 

payment adjustments. 

h. Payment Adjustments and Hardship 

Exceptions 

We are proposing changes to the 

definition of an EHR reporting period 

for a payment adjustment at § 495.4 as 

well as the attestation deadlines for 

certain providers to demonstrate 

meaningful use for an EHR reporting 

period to avoid the Medicare payment 

adjustment. 

i. Summary of Cost Benefit Analysis 

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). Accordingly, we have prepared 

a regulatory impact analysis that to the 

best of our ability presents the costs and 

benefits of the proposed rule. 

The regulatory impact analysis of this 

proposed rule for modification to the 

Medicare and Medicaid EHR Incentive 

Programs from 2015 through 2017 

outlines the reduction in the reporting 

burden for providers demonstrating 

meaningful use in 2015 and estimates 

the total annual cost savings. The low 

and high estimates for these total 

savings are $52,547,132 and 

$68,617,864 respectively. In addition to 

these reductions, we believe there are 

substantial cost savings accruing to 

eligible hospitals and EPs related to 

having additional time to achieve 

meaningful use. 

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 

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20350 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 

Incentive Program would consist of 

three different stages of meaningful use 

requirements. 

In the September 4, 2012 Federal 

Register (77 FR 53967 through 54162), 

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 (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. 

In the March 30, 2015 Federal 

Register, we published a proposed rule 

entitled ‘‘Medicare and Medicaid 

Programs; Electronic Health Record 

Incentive Program Stage 3’’ (80 FR 

16731 through 16804). In this March 30, 

2015 Stage 3 proposed rule, we 

specified the proposed meaningful use 

criteria that EPs, eligible hospitals, and 

critical access hospitals must meet in 

order to demonstrate meaningful use of 

certified EHR technology for Stage 3 of 

the EHR Incentive Programs. It also 

specifies the proposed requirements for 

electronic submission of CQMs and 

creates a single set of meaningful use 

requirements for Stage 3 which would 

be optional for providers in 2017 and 

required for all providers beginning in 

2018. Finally, the Stage 3 proposed rule 

would also change the EHR reporting 

period so that all providers would 

report under a calendar year timeline. 

For Stages 1 and 2, CMS and the ONC 

worked closely to ensure that the 

definition of meaningful use of CEHRT 

and the associated standards and 

certification criteria were coordinated. 

(Current ONC regulations may be found 

at 45 CFR part 170.) For the Stage 3 

proposed rule and the ONC 2015 

Edition proposed rule, CMS and ONC 

have aligned the proposed rules (80 FR 

16731 through 16804 and 80 FR 16804 

through 16921) and would again work 

together to align the final regulations. 

(Readers may also visit: 

www.cms.hhs.gov/

EHRincentiveprograms and 

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. Introduction 

When the EHR Incentive Program 

began in 2011, the requirements for the 

objectives and measures of meaningful 

use were designed to begin a process 

toward health care delivery system 

transformation aligning with 

foundational goals defined in the 

HITECH Act. First, 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). To meet 

this goal, we established stages of 

meaningful use to move providers along 

a progression from adoption to 

advanced use of certified EHR 

technology. Second, the statute includes 

requirements for the use of EHR 

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technology, which defines both the 

functions that should be available 

within the EHR and the purpose to 

which those functions should be 

applied. These requirements include 

functions that are similar to the 

following (see section 1848(o)(4) of the 

Act)— 

• The capacity to provide clinical 

decision support; 

• To support provider order entry; 

• To capture and query information 

relevant to health care quality; and 

• To exchange protected health 

information with, and integrate such 

information from other sources. 

The statute also defines key 

foundational principles of meaningful 

use such as electronic prescribing, the 

electronic exchange of health 

information to support the improvement 

of care and care coordination, and the 

use of EHR technology to submit 

information on clinical quality measures 

and other measures (see section 

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

Since the EHR Incentive Programs 

began in 2011, a number of 

environmental changes have occurred 

which prompted us to reevaluate the 

program requirements in relation to 

progress toward goals. These changes 

include a wide range of factors 

including— 

• Expansion of basic certified EHR 

technology infrastructure; 

• Advancements in EHR and related 

health information technology; 

• Widespread adoption of certain 

standards and functionality; 

• Increased use of CEHRT to support 

quality improvement; and 

• Performance on certain measures 

reaching maximum potential. 

The Certified Health IT Product List 

(ONC CHPL) developed by ONC assists 

providers in identifying certified EHR 

technology products that have been 

certified by an ONC-Authorized 

Certification Body (ONC–ACB). 

Certified EHR technology products, 

certified to the 2014 Edition, are 

required for use in the Medicare and 

Medicaid EHR Incentive Programs to 

meet meaningful use criteria for Stage 1 

and 2 for an EHR reporting period in 

2015. We reviewed data related to the 

ONC CHPL as of March 20, 2015 and 

found 1956 unique products that are 

currently certified to the 2011 Edition 

and 2157 unique products that are 

certified to the 2014 Edition. A unique 

product is a product that is certified and 

receives a unique certification ID 

(product updates and product version 

changes are included in the unique 

product count). Data from March 2013 

to March 2015 shows an increase of 104 

percent in the total number of certified 

EHR technology products and an 

increase of 133 percent in total unique 

certified EHR technology products in 

the last 2 years alone. We believe the 

increase in the number of certified EHR 

technology products available is a 

positive step for providers seeking to 

meet meaningful use requirements and 

advance EHR technology. The data 

provided and additional information 

related to the ONC CHPL may be found 

on the HealthIT.gov Web site at http:// 

healthit.gov/chpl. 

For a wide range of data and reports 

on health IT adoption rates, use of 

certification functions and standards, 

updates to eCQM specifications and 

testing, as well as the performance data 

for providers in relation to the available 

software, we direct readers to the ONC 

Web site (http://www.healthit.gov), the 

CMS eCQM Library (http://cms.gov/

Regulations-and-Guidance/Legislation/

EHRIncentivePrograms/eCQM_

Library.html), and the CMS EHR 

Incentive Programs data and reports 

Web site (http://www.cms.gov/

Regulations-and-Guidance/Legislation/

EHRIncentivePrograms/DataAnd

Reports.html). 

As the program has increased the 

overall adoption of EHRs and as EHR 

technology has automated certain 

clinical functions and supported 

standardized data capture, we propose 

modifications, which would recognize 

these changes and realign the program 

with ongoing program goals. Our quality 

reporting programs regularly reevaluate 

measures based on factors like clinical 

relevance, updates to electronic 

specifications, and measure 

performance. We consider modifications 

to the objectives and measures of this 

program similar to those regularly made 

in our quality reporting programs. 

In addition to these environmental 

changes, stakeholder associations and 

provider groups have through 

correspondence, public forums, and 

public comment requested that we 

consider changes to the requirements to 

demonstrate meaningful use of certified 

EHR technology in the EHR Incentive 

Programs which would reduce the 

overall complexity of the program and 

the burden on providers. We believe 

some of these recommended changes 

may contradict certain statutory 

requirements for this program. For 

example, certain provisions such as 

electronic prescribing or health 

information exchange cannot be fully 

‘‘optional’’ because they are expressly 

required under the statute (see section 

1848(o)(2)(A) of the Act). The statutory 

directive to require increasingly more 

stringent measures of meaningful use 

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

prohibits the removal of all measure 

thresholds. Further examples are also 

discussed in the Stage 3 proposed rule 

at (80 FR 16737 through 16742). 

However, there are methods that 

could be employed to modify Stages 1 

and 2 of the program to address 

stakeholder concerns, meet the statutory 

requirements for the program defined in 

the HITECH Act, and continue to 

support progress toward the program’s 

foundational goals. In addition, these 

methods would move providers along a 

continuum from data capture to 

advanced use of certified EHR 

technology including electronic 

prescribing, health information 

exchange, and quality improvement 

with increasingly stringent measures as 

identified in the Act and discussed in 

section II.B.1.b. of this proposed rule. 

Therefore, we are proposing 

modifications to Stages 1 and 2 and are 

seeking public comment on these 

proposals, which are intended to be 

responsive to the changing environment 

and to stakeholder concern over 

program complexity and redundant 

reporting requirements. We propose 

these modifications to address these 

concerns and to continue to support the 

overall goal of the widespread adoption 

and meaningful use of EHR technology 

in efforts to transform our health care 

delivery system and improve health care 

quality. 

B. Meaningful Use Requirements for 

EHR Reporting Periods in 2015 Through 

2017 

1. Definitions Across the Medicare Fee 

for Service, Medicare Advantage, and 

Medicaid Programs 

a. Uniform Definitions 

As discussed in prior 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. (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 respectively.) (For discussion of 

the proposed changes to uniform 

definitions outlined in the Stage 3 

proposed rule, we refer readers to the 

Stage 3 proposed rule at (80 FR 16736 

through 16737). 

In this proposed rule, we are 

proposing to maintain the previously 

finalized uniform definitions except as 

stated in this proposed rule. 

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b. Changes to Definitions for 2015 

Through 2017 

We are proposing changes to a 

number of definitions previously 

finalized for meaningful use in the Stage 

1 and Stage 2 rules in order to modify 

the program in response to the changing 

health IT environment and related 

stakeholder concerns. These changes 

address the following: 

• An overall simplification of the 

program aligned to the overarching 

goals of sustainability as discussed in 

the Stage 3 proposed rule (80 FR 16737) 

and in section II.B.1.b.(1). of this 

proposed rule and a related change to 

requirements necessary to accommodate 

these changes outlined in section 

II.B.1.b.(2) of this proposed rule. 

• Moving all providers to an EHR 

reporting period aligned with the 

calendar year as outlined in section 

II.B.1.b.(3).A. of this proposed rule. 

• Providing flexibility for providers 

in 2015 to accommodate the proposed 

changes as outlined in section II.B.1.b of 

this proposed rule. 

• Removing requirements for 

objectives and measures which are 

redundant or duplicative or which have 

‘‘topped out’’ as described at (80 FR 

16767) of the Stage 3 proposed rule and 

outlined in section II.B.1.c.(1). of this 

proposed rule. 

• Restructuring the remaining 

measures and objectives to streamline 

requirements for 2015 through 2017 and 

to accommodate the changes for an EHR 

reporting period in 2015 as outlined in 

section II.B.1.c.(2). of this proposed rule. 

• Refocusing the existing program on 

building toward advanced use of EHR 

technology, aligned with the Stage 3 

proposed rule, through maintaining the 

objectives and measures outlined in 

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

(1) Stages of Meaningful Use 

In the phased approach to meaningful 

use, we finalized 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 in Stages 1 and 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 as finalized in 

prior rulemaking is outlined in Table 1. 

TABLE 1—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 

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

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

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

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

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

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

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

In the Stage 3 proposed rule, we noted 

our intent for Stage 3 to be the final 

stage in meaningful use and that no 

further stages would be developed. We 

further proposed that all providers may 

optionally move to Stage 3 in 2017, and 

that all providers are required to move 

to Stage 3 beginning in 2018 regardless 

of their prior participation or stage of 

meaningful use. (For further discussion 

on this proposal, we direct readers to 

(80 FR 16774). 

In this proposed rule to modify Stages 

1 and 2 for meaningful use in 2015 

through 2017, we propose to further 

reduce complexity in the program and 

work toward this overall shift to a single 

set of objectives and measures in Stage 

3 in 2018. We propose to require all 

providers to attest to a single set of 

objectives and measures beginning with 

an EHR reporting period in 2015. These 

objectives and measures would leverage 

existing objectives and measures of 

meaningful use. Because this change 

may occur after providers have already 

begun their work toward meeting 

meaningful use in 2015, we propose 

accommodations within individual 

objectives for providers in different 

stages of meaningful use. These 

accommodations include retaining the 

different specifications between Stage 1 

and Stage 2, and allowing special 

exclusions for certain objectives or 

measures for eligible providers 

previously scheduled to participate in 

Stage 1 for an EHR reporting period in 

2015. 

In this rule, we propose all providers 

would be required to attest to certain 

objectives and measures finalized in the 

Stage 2 final rule, which would align 

with those objectives and measures 

proposed for Stage 3 of meaningful use. 

In effect, this would create a new 

progression using the existing objectives 

and measures where providers attest to 

a modified version of Stage 2 with 

accommodations for Stage 1 providers 

(equivalent to a reduced version of Stage 

3) in 2015; a modified version of Stage 

2 in 2016 (equivalent to a reduced 

version of Stage 3); either a modified 

version of Stage 2 (equivalent to a 

reduced version of Stage 3) or the full 

version of Stage 3 outlined in the Stage 

3 proposed rule in 2017; and the full 

version of Stage 3 outlined in the Stage 

3 proposed rule beginning in 2018. 

The revised timeline based on this 

proposal and the Stage 3 proposed rule 

is outlined in Table 2. 

TABLE 2—STAGE OF MEANINGFUL USE CRITERIA BY FIRST YEAR

First year as a 

meaningful EHR 

user 

Stage of meaningful use 

2015 2016 2017 2018 

2011 ........................ Modified Stage 2 ........................ Modified Stage 2 ........................ Modified Stage 2 Or Stage 3 ..... Stage 3 

2012 ........................ Modified Stage 2 ........................ Modified Stage 2 ........................ Modified Stage 2 Or Stage 3 ..... Stage 3 

2013 ........................ Modified Stage 2 ........................ Modified Stage 2 ........................ Modified Stage 2 Or Stage 3 ..... Stage 3 

2014 ........................ Modified Stage 2 * ...................... Modified Stage 2 ........................ Modified Stage 2 Or Stage 3 ..... Stage 3 

2015 ........................ Modified Stage 2 * ...................... Modified Stage 2 ........................ Modified Stage 2 Or Stage 3 ..... Stage 3 

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TABLE 2—STAGE OF MEANINGFUL USE CRITERIA BY FIRST YEAR—Continued 

First year as a 

meaningful EHR 

user 

Stage of meaningful use 

2015 2016 2017 2018 

2016 ........................ - NA - .......................................... Modified Stage 2 ........................ Modified Stage 2 Or Stage 3 ..... Stage 3 

* The Modifications to Stage 2 proposed in this rule include alternate exclusions and specifications for certain objectives and measures for providers that were scheduled to demonstrate Stage 1 of meaningful use in 2015. 

For simplification and reader clarity, 

we would therefore refer to the ‘‘Stage’’ 

designation in relation to the EHR 

Incentive Program rules and to the 

objectives and measures as follows: 

• Meaningful use objectives and 

measures for 2015 through 2017 

• Stage 3 meaningful use objectives 

and measures for 2017 and subsequent 

years 

This alignment of Stages 1 and 2 to 

the proposals for Stage 3 essentially 

creates a new paradigm for providers in 

2015 through 2017. This includes a 

simplified structure and focus on the 

objectives and measures with 

sustainable growth potential aligned to 

the programs foundational goals prior to 

the full implementation of Stage 3 in 

2018. This change could alleviate the 

need to include the option in 2017 to 

allow providers to choose to 

demonstrate Stage 3 of the program in 

2017. To better understand the impact 

and potential complexity, we seek 

comment on whether or not we should 

implement only the modifications 

proposed in this rule from 2015 through 

2017 and begin Stage 3 in 2018 without 

an option year in 2017, or if we should 

allow providers the option to 

demonstrate Stage 3 beginning in 2017 

as discussed in the Stage 3 proposed 

rule (80 FR 16774). 

We seek comment on these proposals. 

(2) Meaningful EHR User 

In the Stage 3 proposed rule (80 FR 

16731 through 16804), we proposed to 

modify the definition of ‘‘Meaningful 

EHR User’’ in 42 CFR 495.4 to include 

the Stage 3 objectives and measures 

proposed at § 495.7. We further propose 

to redesignate some of the numbering of 

the regulation text under Part 495 to 

more clearly identify which sections of 

the regulation apply to specific years of 

the program. This would allow more 

direct references for the objectives and 

measures, while also preserving the 

content that applies for prior program 

years. We note this numerical 

redesignation would not affect the 

content of the regulation text except 

where noted in this proposed rule, nor 

would it change the proposed objectives 

and measures of Stage 3 of meaningful 

use at (80 FR 16745 through 16767). The 

redesignated numerical references for 

the regulation text are as follows: 

Current section designation Proposed section redesignation 

§ 495.6—Objectives and Measures .......................................................... § 495.20—Objectives and Measures Prior to 2015 

§ 495.22—Objectives and Measures Beginning in 2015 

§ 495.7 *—Stage 3 Objectives and Measures .......................................... § 495.24—Stage 3 Objectives and Measures 

§ 495.8—Demonstration of Meaningful Use ............................................. § 495.40—Demonstration of Meaningful Use 

§ 495.10—Participation Requirements ..................................................... § 495.60—Participation Requirements 

* Indicates a new section that was proposed in the Stage 3 proposed rule. 

In this proposed rule, we refer to 

§ 495.20 for the objectives and measures 

that apply for years prior to 2015, 

§ 495.22 for the objectives and measures 

proposed in this rule for 2015 through 

2017, and § 495.24 for the objectives and 

measures proposed in the Stage 3 

proposed rule for 2017 and subsequent 

years. Pending public comment and 

agency review of these proposals, all 

changes in Part 495 would be reconciled 

through the final rule. 

(3) EHR Reporting Periods in 2015 

Through 2017 

In 42 CFR 495.4, we define an EHR 

reporting period for eligible hospitals 

and CAHs based on the federal fiscal 

year (October 1 through September 30). 

However, the fiscal year EHR reporting 

period has resulted in varying reporting 

timelines between provider types and a 

shortened timeline for system 

developers to meet hospital and CAH 

technology needs. In the Stage 3 

proposed rule, we outline changes to the 

EHR reporting period beginning with 

the EHR reporting period in 2017 in 

order to move eligible hospitals and 

CAHs to EHR reporting periods based 

on a calendar year. (For further 

discussion of this proposal and the 

relationship to program alignment with 

quality reporting programs, we direct 

readers to 80 FR 16739.) 

In this proposed rule, our intent is to 

modify the program to remove 

redundant and duplicative measures; 

reduce reporting burden for measures 

that have ‘‘topped out’’ while preserving 

the program’s foundational goals and 

the requirement for stringent or robust 

measurement; and better align the 

existing program with other CMS 

quality reporting programs. In order to 

move these efforts forward and to 

accommodate the proposed changes 

beginning in 2015 while still allowing 

providers time to complete an EHR 

reporting period after the effective date 

of a final rule, we are proposing changes 

to the uniform definition of an ‘‘EHR 

reporting period’’ in § 495.4 beginning 

in 2015. We are also proposing similar 

changes to the definition of an ‘‘EHR 

reporting period for a payment 

adjustment year’’ in § 495.4 beginning in 

2015 as discussed in section II.E.1. of 

this proposed rule. We are proposing 

changes to the attestation deadlines for 

purposes of the incentive payments and 

payment adjustments in section I.A.1.i. 

of this proposed rule. 

(a) Calendar Year Reporting Beginning 

in 2015 

Beginning in 2015, we are proposing 

to change the definition of ‘‘EHR 

reporting period’’ at § 495.4 for EPs, 

eligible hospitals, and CAHs such that 

the EHR reporting period would begin 

and end in relation to a calendar year. 

This change would allow eligible 

hospitals and CAHs the same amount of 

time as EPs from the release of a new 

edition by ONC to the required date for 

full implementation of the EHR 

technology certified in accordance with 

those criteria. In addition, this change 

would allow providers additional time 

to accommodate the changes proposed 

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in this rule for demonstrating 

meaningful use in 2015. Finally, this 

change would align EHR reporting 

periods for the EHR Incentive Program 

with EHR reporting periods in CMS 

quality reporting programs, which have 

similar or related requirements. 

In this proposal, all providers (EPs, 

eligible hospitals, and CAHs) would be 

required to complete an EHR reporting 

period within January 1 and December 

31 of the calendar year in order to 

demonstrate meaningful use. In order to 

accommodate eligible hospitals and 

CAHs that may have planned their EHR 

reporting period in 2015 during the 

federal fiscal year and want to continue 

to use that time period for reporting, we 

propose for 2015 only these providers 

may begin an EHR reporting period as 

early as October 1 of 2014 and end by 

December 31 of 2015. Beginning with 

2016, the EHR reporting period must be 

completed within January 1 and 

December 31 of the calendar year. 

We seek comment on this proposal. 

(b) 90-Day EHR Reporting Period for All 

Providers in 2015 

In the 2014 CEHRT Flexibility rule 

(79 FR 52919) we noted that many 

commenters had requested a 90-day 

EHR reporting period in 2015. In that 

rule, we discussed the reasons we did 

not propose or finalize a change to allow 

for an EHR reporting period of 90 days 

in 2015. We stated that we did not 

finalize changes to the EHR reporting 

period, because we believed such 

changes were not necessary to mitigate 

risk associated with the delay in the 

availability of EHR technology certified 

to the 2014 Edition (79 FR 52919). In 

addition, we stated that such changes 

would put the forward progress of the 

program at risk, and potentially cause 

further delay in implementing effective 

health IT infrastructure and 

misalignment with the CMS quality 

reporting programs (79 FR 52919). We 

maintain the assertion that the delay in 

2014 Edition availability does not 

necessitate changes to the EHR reporting 

period 2015; and that the proposed 

change to the EHR reporting period in 

2015 in conjunction with the other 

modifications to the EHR Incentive 

Program proposed in this rule does 

represent a potential risk to the 

continued development of effective 

health IT infrastructure. 

Subsequent to the publication of the 

2014 CEHRT Flexibility final rule, we 

conducted a full analysis of provider 

performance on Stage 1 and Stage 2 

measures and identified areas where 

measures were topped out or had 

become redundant or duplicative based 

on the widespread adoption of EHR 

technology certified to the 2014 Edition 

and successful implementation of the 

more complex Stage 2 objective 

functions. We determined that there was 

significant potential for a positive 

impact through reducing the reporting 

burden, simplifying the program, and 

realigning the program with long term 

goals for advanced use of EHRs. 

However, in order to implement these 

changes, a shortened EHR reporting 

period would be necessary in 2015 to 

allow both providers and CMS time to 

make necessary changes to systems. We 

believe the benefits to be gained from 

the proposals in this rule outweigh the 

potential risk of misalignment 

introduced by the shortened reporting 

period, if the risk is limited to only be 

allowable for an EHR reporting period 

in 2015. Therefore, we are proposing to 

allow a 90-day EHR reporting period in 

2015 only to accommodate 

implementation of the other changes 

proposed in this rule. 

For 2015 only, we are proposing to 

change the definition of ‘‘EHR reporting 

period’’ at § 495.4 for EPs, eligible 

hospitals, and CAHs such that the EHR 

reporting period in 2015 would be any 

continuous 90-day period within the 

calendar year. We intend this change to 

allow providers adequate time to plan 

for any necessary changes to their 

implementation of meaningful use 

required in order to accommodate the 

changes outlined in this proposed rule. 

We further believe this change is 

responsive to provider and stakeholder 

feedback received through 

correspondence, public forums, and 

public comment, which requested that 

we allow a 90-day EHR reporting period 

in 2015 in order to provide flexibility 

for continuing difficulties providers are 

experiencing with successful 

implementation of EHR technology 

certified to the 2014 Edition. 

We propose that for an EHR reporting 

period in 2015, eligible professionals 

may select an EHR reporting period of 

any continuous 90-day period from 

January 1, 2015 through December 31, 

2015; while eligible hospitals and CAHs 

may select an EHR reporting period of 

any continuous 90-day period from 

October 1, 2014 through December 31, 

2015. This is intended to accommodate 

the shift from reporting based on the 

federal fiscal year to the calendar year 

for eligible hospitals and CAHs. 

In 2016, for eligible professionals, 

eligible hospitals, and CAHs that have 

not successfully demonstrated 

meaningful use in a prior year and are 

first-time participants in the program, 

the EHR reporting period would be any 

continuous 90-day period between 

January 1, 2016 and December 31, 2016. 

However, for all returning participants 

that have successfully demonstrated 

meaningful use in a prior year, the EHR 

reporting period would be a full 

calendar year from January 1, 2016 

through December 31, 2016. In 2017, the 

EHR reporting period would be 1 full 

calendar year for all providers, as 

proposed in the Stage 3 proposed rule 

(80 FR 16739). 

We invite comment on these 

proposals. 

c. Definition of Meaningful Use 

(1) Considerations in Defining 

Meaningful Use 

In order to update the definition of 

meaningful use of certified EHR 

technology and make modifications to 

program requirements to reflect a 

changing health IT environment, we 

analyzed the existing objectives and 

measures of meaningful use to consider 

if they should be modified for the 

program beginning in 2015. As outlined 

in the Stage 3 proposed rule, we looked 

at the set of potential objectives and 

measures for inclusion in the program 

for 2017 and subsequent years, and 

sought to determine if they were 

redundant, duplicative, or had reached 

a performance level considered to be 

‘‘topped out.’’ We stated that redundant 

measures include those objectives 

where there is now a viable health ITbased solution which may replace 

paper-based actions and therefore a 

provider should no longer be required to 

also report on the objective where the 

measures includes paper-based actions, 

such as the Stage 2 Clinical Summary 

objective (77 FR 53998 through 54002). 

We stated that duplicative measures 

include those objectives where a 

measure which is also captured in the 

course of meeting another objective, 

such as recording vital signs which is 

also a required part of the Consolidated 

Clinical Document Architecture (C– 

CDA) in the Summary of Care objective 

(77 FR 54014 through 54016). Finally, 

we stated that ‘‘topped out’’ measures 

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. (For further discussion 

of this approach to identifying the 

objectives and measures for Stage 3, we 

direct readers to (80 FR 16740 through 

16744). 

In this proposed rule, we have taken 

a similar approach to review the current 

objectives and measures of meaningful 

use with a few additional 

considerations. These included 

reviewing the functions and standards 

included the 2014 Edition when 

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1CMS EHR Incentive Programs Web site: ‘‘Data 

and Reports’’ https://www.cms.gov/Regulationsand-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html. 

determining if a measure is redundant 

or duplicative; and adding a review of 

isolated performance rates for providers 

in the first year of meaningful use in 

addition to reviewing quartile 

performance rates for topped out 

measures. (For further discussion on 

‘‘topped out’’ measures in the Stage 3 

proposed rule, we direct readers to (80 

FR 16741 and 16742). For further 

information on the performance rates for 

new participants as well as quartile 

performance rates for individual 

measures, we direct readers to the CMS 

EHR Incentive Program Web site data 

and reports page.1

Our analysis of the objectives and 

measures of meaningful use Stages 1 

and 2 identified a number of measures, 

which meet these criteria as either 

redundant, duplicative, or topped out 

with new participants consistently 

performing at a statistically comparable 

rate to returning participants. Table 3 

identifies the current objectives and 

measures which meet these criteria. We 

are therefore proposing to no longer 

require providers to attest to these 

objectives and measures as currently 

codified in the CFR under § 495.6 in 

order to demonstrate meaningful use 

beginning in 2015. 

TABLE 3—OBJECTIVES AND MEASURES IDENTIFIED BY PROVIDER TYPE WHICH ARE REDUNDANT, DUPLICATIVE OR

TOPPED OUT

Provider type Objectives and measures 

Eligible Professional ............. Record Demographics .................................................... 42 CFR § 495.6 (j)(3)(i) and (ii). 

Record Vital Signs .......................................................... 42 CFR § 495.6 (j)(4)(i) and (ii). 

Record Smoking Status .................................................. 42 CFR § 495.6 (j)(5)(i) and (ii). 

Clinical Summaries ......................................................... 42 CFR § 495.6 (j)(11)(i) and (ii). 

Structured Lab Results ................................................... 42 CFR § 495.6 (j)(7)(i) and (ii). 

Patient List ...................................................................... 42 CFR § 495.6 (j)(8)(i) and (ii). 

Patient Reminders ........................................................... 42 CFR § 495.6 (j)(9)(i) and (ii). 

Summary of Care ............................................................

Measure 1—Any Method 

Measure 3—Test 

42 CFR § 495.6 (j)(14)(i) and (ii). 

Electronic Notes .............................................................. 42 CFR § 495.6 (j)(9)(i) and (ii). 

Imaging Results .............................................................. 42 CFR § 495.6 (k)(6)(i) and (ii). 

Family Health History ...................................................... 42 CFR § 495.6 (k)(2)(i) and (ii). 

Eligible Hospital/CAH ........... Record Demographics .................................................... 42 CFR § 495.6 (l)(2)(i) and (ii). 

Record Vital Signs .......................................................... 42 CFR § 495.6 (l)(3)(i) and (ii). 

Record Smoking Status .................................................. 42 CFR § 495.6 (l)(4)(i) and (ii). 

Structured Lab Results ................................................... 42 CFR § 495.6 (l)(6)(i) and (ii). 

Patient List ...................................................................... 42 CFR § 495.6 (l)(7)(i) and (ii). 

Summary of Care ............................................................

Measure 1—Any Method 

Measure 3—Test 

42 CFR § 495.6 (l)(11)(i) and (ii). 

eMAR .............................................................................. 42 CFR § 495.6 (l)(16)(i) and (ii). 

Advanced Directives ....................................................... 42 CFR § 495.6 (m)(1)(i) and (ii). 

Electronic Notes .............................................................. 42 CFR § 495.6 (m)(2)(i) and (ii). 

Imaging Results .............................................................. 42 CFR § 495.6 (m)(2)(i) and (ii). 

Family Health History ...................................................... 42 CFR § 495.6 (m)(3)(i) and (ii). 

Structure Labs to Ambulatory Providers ......................... 42 CFR § 495.6 (m)(6)(i) and (ii). 

We note that many of these objectives 

and measures include actions that may 

be valuable to providers and patients, 

such as providing a clinical summary to 

a patient after an office visit. We 

encourage providers to continue to 

conduct these activities as best suits 

their practice and the preferences of 

their patient population. The removal of 

these measures is in no way intended as 

a removal of endorsement of these best 

practices or to discourage providers 

from conducting and tracking these 

activities for their own quality 

improvement goal. Instead, we would 

no longer require providers to calculate 

and attest to the results of these 

measures in order to demonstrate 

meaningful use beginning in 2015. 

We seek comment on this proposal. 

(2) Changes to Definition of Meaningful 

Use for 2015 Through 2017 

In order to implement the proposed 

changes to no longer require providers 

to attest to their performance on the 

identified objectives and measures and 

to accomplish the related goal of 

restructuring the program to align with 

long-term goals, there are a number of 

changes, which must be made to other 

requirements of meaningful use. These 

changes fall into the following two 

major categories: 

• Changes to streamline the structure 

for 2015 through 2017 to align with the 

proposed structure for Stage 3 of 

meaningful use in 2017 and subsequent 

years; and 

• Changes to accommodate this shift 

to allow providers to successfully 

demonstrate meaningful use for an EHR 

reporting period in 2015. 

In addition, we have heard from 

stakeholder associations and provider 

representatives that providers have 

faced significant challenges in 

implementing the patient engagement 

objectives, which require patient action. 

These are outlined in the Stage 2 final 

rule at 77 FR 54046 under the Health 

Outcomes Policy Priority ‘‘Engage 

patients and families in their care’’: The 

Patient Electronic Access objective 

Stage 2 measure 2 for more than 5 

percent of patients to view, download or 

transmit their health information; and, 

the EPs secure electronic messaging 

objective for more than 5 percent of 

patients to send a secure message using 

CEHRT. These concerns have included 

both the barriers to successful 

implementation of the required health 

IT or CEHRT functions necessary to 

support the measures and especially the 

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secure transmission function; and the 

challenges to effectively changing 

patient behavior including patient IT 

knowledge gaps, lack of widespread 

access to technologies, and cultural 

barriers among specific patient 

populations. We recognize these 

concerns and are proposing changes to 

these objectives to allow providers to 

focus on improvements without 

jeopardizing their ability to successfully 

demonstrate meaningful use. These 

changes are outlined in section 

II.B.1.c.(2).(c). of this proposed rule. 

(a) Structural Requirements of 

Meaningful Use in 2015 Through 2017 

If we remove the requirement to attest 

to the identified measures and 

objectives, the distribution requirements 

between menu and core objectives can 

no longer be applicable. In addition, 

stakeholder associations and provider 

representatives have expressed through 

correspondence, public forum, and 

public comment on regulation that the 

core and menu structure is 

unnecessarily complex and a source of 

confusion for providers. Therefore, we 

propose to eliminate the distinction 

between core and menu objectives, and 

further propose that all retained 

objectives and measures would be 

required for the program. We note that 

for Stage 1 providers, this means three 

current menu objectives would now be 

required; and for Stage 2 eligible 

hospitals and CAHs, one current menu 

objective would now be a required 

objective. These objectives are as 

follows: 

• Stage 1 Menu: Perform Medication 

Reconciliation 

• Stage 1 Menu: Patient Specific 

Educational Resources 

• Stage 1 Menu: Public Health 

Reporting Objectives (multiple 

options) 

• Stage 2 Menu Eligible Hospitals and 

CAHs Only: Electronic Prescribing 

We note that the objectives and 

measures retained in each case for all 

providers would be the Stage 2 

objectives and measures; however, we 

are proposing to establish alternate 

exclusions and specifications to mitigate 

any additional burden on providers for 

an EHR reporting period in 2015. These 

related proposals are discussed further 

in section II.B.3.c.(2).(b). of this 

proposed rule. 

For the public health reporting 

objectives and measures, we are 

proposing to consolidate the different 

Stage 2 core and menu objectives into a 

single objective with multiple measure 

options. We proposed this approach for 

the Stage 3 public health reporting 

objective as we believe it provides 

greater flexibility for providers and 

supports continued efforts to engage 

providers and public health agencies in 

the essential data capture and 

information exchange which supports 

quality improvement, emergency 

response, and population health 

management initiatives. For further 

discussion of the rationale for the Stage 

3 objective, we direct readers to (80 FR 

16731 through 16804). We discuss the 

proposal for the consolidated public 

health reporting objective for 

meaningful use in 2015 through 2017 in 

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

We propose that EPs must select to 

report on any combination of 2 of the 5 

available options outlined in section 

II.B.2.j. of this proposed rule and 

eligible hospitals and CAHs must select 

to report on any combination of 3 of the 

6 available options in section II.B.2.j. of 

this proposed rule. If a provider is 

scheduled to attest to Stage 1 of 

meaningful use in 2015, we propose to 

allow these EPs in 2015 to select to 

report on only 1 of the 5 available 

options outlined in section II.B.2.j. of 

this proposed rule and these eligible 

hospitals and CAHs in 2015 to select to 

report on any combination of 2 of the 6 

available options in section II.B.2.j. of 

this proposed rule. 

Therefore, we propose that the 

structure of meaningful use for 2015 

through 2017 would be 9 required 

objectives for EPs using the Stage 2 

objectives for EPs with alternate 

exclusions and specifications for Stage 1 

providers in 2015. We propose that the 

structure of meaningful use for 2015 

through 2017 would be 8 required 

objectives for eligible hospitals and 

CAHs using the Stage 2 objectives for 

eligible hospitals and CAHs with 

alternate exclusions and specifications 

for Stage 1 providers and some stage 2 

providers in 2015. In addition, EPs 

would be required to report on a total 

of 2 measures from the public health 

reporting objective or meet the criteria 

for exclusion from up to 5 measures, 

and eligible hospitals and CAHs would 

be required to report on a total of 3 

measures from the public health 

reporting objective or meet the criteria 

for exclusion from up to 6 measures. We 

reiterate that the alternate exclusions 

and specifications mentioned are further 

defined in section II.B.1.c.(2).(b). of this 

section of this proposed rule, and the 

objectives and measures are defined in 

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

TABLE 4—CURRENT STAGE STRUCTURE, RETAINED OBJECTIVES, AND PROPOSED STRUCTURE

Current stage 1 

structure Retained objectives Proposed structure 

EP ................................. 13 core objectives ..............................

5 of 9 menu objectives including 1 

public health objective.

6 core objectives ................................

3 menu objectives ..............................

2 public health objectives ...................

9 core objectives. 

1 public health objective (2 measure 

options). 

EH/CAH ........................ 11 core objectives ..............................

5 of 10 menu objectives including 1 

public health objective.

5 core objectives ................................

3 menu objectives ..............................

3 public health objectives ...................

8 core objectives. 

1 public health objective (3 measure 

options). 

EP ................................. 17 core objectives including public 

health objectives.

3 of 6 menu objectives .......................

9 core objectives ................................

0 menu objectives ..............................

4 public health objectives ...................

9 core objectives. 

1 public health objective (2 measure 

options). 

EH/CAH ........................ 16 core objectives including public 

health objectives.

3 of 6 menu objectives .......................

7 core objectives ................................

1 menu objective ................................

3 public health objectives ...................

8 core objectives. 

1 public health objective (3 measure 

options). 

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2CMS EHR Incentive Programs Web site: ‘‘Data 

and Reports: Performance data through February 

2015’’ https://www.cms.gov/Regulations-andGuidance/Legislation/EHRIncentivePrograms/

Downloads/AttestationPerformanceData_

Feb2015.pdf 

(b) Alternate Exclusions and 

Specifications for Stage 1 Providers for 

Meaningful Use in 2015 

We are proposing several alternate 

exclusions and specifications for 

providers scheduled to demonstrate 

Stage 1 of meaningful use in 2015, 

which would allow these providers to 

continue to demonstrate meaningful use 

despite the proposals to use only the 

Stage 2 objectives and measures 

identified for meaningful use in 2015 

through 2017. These provisions fall into 

the following two major categories: 

• Maintaining the specifications for 

objectives and measures which have a 

lower threshold or other measure 

difference between Stage 1 and Stage 2. 

• Establishing an exclusion for Stage 

2 measures which do not have an 

equivalent Stage 1 measure associated 

with any Stage 1 objective or where the 

provider did not plan to attest to the 

menu objective which would now be 

otherwise required. 

For the first category, we propose that 

providers who are scheduled to 

demonstrate Stage 1 of meaningful use 

for an EHR reporting period in 2015 

may attest to meaningful use using the 

specifications established for the Stage 1 

objectives and measures defined at 42 

CFR 495.6 for each retained objective or 

measure where there is a difference in 

specifications between Stages 1 and 2. 

For example, in Stage 1 the electronic 

prescribing objective for EPs requires 

that ‘‘More than 40 percent of all 

permissible prescriptions written by the 

EP are transmitted electronically using 

certified EHR technology’’ (75 FR 

44338). While the Stage 2 electronic 

prescribing objectives requires that 

‘‘More than 50 percent of all permissible 

prescriptions written by the EP are 

compared to at least one drug formulary 

and transmitted electronically using 

Certified EHR Technology’’ (77 FR 

53990). Therefore, we are proposing that 

for an EHR reporting period in 2015, 

providers scheduled to demonstrate 

Stage 1 of meaningful use may attest 

based on the specifications associated 

with the Stage 1 measure. We note that 

for an EHR reporting period beginning 

in 2016, all providers must attest to the 

specifications including the measure 

thresholds associated with the Stage 2 

measure. For an EHR reporting period in 

2016, all providers, including those who 

would otherwise be scheduled for Stage 

1 in 2016, would be required to meet the 

Stage 2 specifications with no alternate 

exclusions. 

For the second category, we note that 

some objectives, such as the Patient 

Electronic Access objective, have the 

same requirements for one measure 

(more than 50 percent of patients are 

provided access to view, download, and 

transmit their health information) for 

both Stage 1 and Stage 2, but also have 

an additional measure for Stage 2 (more 

than 5 percent of patients view, 

download, or transmit their health 

information). Other objectives, such as 

the Summary of Care objective, are 

designated as a menu objective for Stage 

1 but are a core objective for Stage 2 and 

also may have additional measure 

requirements in Stage 2 that are not 

applicable for Stage 1 (77 FR 54013 

through 54017). Finally, some objectives 

consist of requirements from multiple 

objectives from Stage 1 that were 

consolidated into a single objective for 

Stage 2 such as drug-drug and drugallergy decision support interventions. 

For these consolidated objectives, all 

providers would be required to attest to 

the Stage 2 objective and measures. For 

objectives where there is a measure that 

is not equivalent between Stage 1 and 

Stage 2 or where the objective moves 

from menu to core between Stage 1 and 

Stage 2, we propose to include an 

exclusion for providers who were 

scheduled to demonstrate Stage 1 of 

meaningful use for the EHR reporting 

period in 2015. For example, Stage 1 

providers may exclude from the 

requirement to send an electronic 

summary of care record for more than 

10 percent of transitions of care as 

required in the Stage 2 Summary of Care 

objective measure 2 (75 FR 44364). 

These alternate exclusions and 

specifications for certain objectives and 

measures of meaningful use for an EHR 

reporting period in 2015 are defined for 

each objective and measure in the 

description of each objective and 

measure included in section II.B.2. of 

this proposed rule. 

We invite public comment on this 

proposal. 

(c) Changes to Patient Engagement 

Requirements for 2015 Through 2017 

Through correspondence, public 

forums, and public comment on our 

proposed regulations, stakeholders have 

expressed concern that certain factors 

like demographics, low utilization of 

internet capable technology among their 

patient population, or other external 

barriers which are beyond their control 

are impacting providers’ ability to meet 

certain measures which require 

providers to track patient action. In 

addition, providers and system 

developers have noted through similar 

means an overall immaturity in the 

market with health IT equipped with 

the functions required to support the 

transmission of health information by a 

patient or the delivery of a secure 

message from a patient to a third party. 

Providers have indicated that while they 

support the goal of improved patient 

engagement, these issues are impacting 

their ability to meet the measure 

requirements. We note that data 

obtained from provider attestations 

shows performance on these measures is 

concentrated around the median rate 

(around 20 percent 2) which indicates 

the potential for ongoing performance 

that exceeds the existing threshold. 

However, there is a wide variance at the 

high and low ends, which indicates that 

there may be external factors impacting 

performance. Therefore, we are seeking 

to mitigate these concerns by making 

changes to the related measures. We 

believe these changes would allow 

providers the necessary time to work 

toward patient education about the 

availability of these resources as well as 

allowing the industry as a whole time to 

develop a stronger infrastructure 

supporting patient engagement. 

There are two objectives for EPs and 

one objective for eligible hospitals and 

CAHs, which specifically contain 

measures requiring a provider to track 

patient action. We propose to modify 

these measures as follows: 

• Patient Action To View, Download, or 

Transmit Health Information 

++ Remove the 5 percent threshold 

for Measure 2 from the EP Stage 2 

Patient Electronic Access (VDT) 

objective. Instead require that at least 1 

patient seen by the provider during the 

EHR reporting period views, downloads, 

or transmits his or her health 

information to a third party. This would 

demonstrate the capability is fully 

enabled and workflows to support the 

action have been established by the 

provider. 

++ Remove the 5 percent threshold 

for Measure 2 from the eligible hospital 

and CAH Stage 2 Patient Electronic 

Access (VDT) objective. Instead require 

that at least 1 patient discharged from 

the hospital during the EHR reporting 

period views, downloads, or transmits 

his or her health information to a third 

party. This would demonstrate the 

capability is fully enabled and 

workflows to support the action have 

been established by the provider. 

We seek comment on potential 

alternate proposals for this proposed 

change to the threshold for Measure 2 of 

the Stage 2 Patient Electronic Access 

objective. For example, we seek 

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comment on potential alternates such as 

a percentage threshold less than 5 

percent, or a numerator greater than 10 

patients, or another similar numerical 

alternative. We further seek comment on 

suggestions for other potential 

alternatives which would accomplish 

the goals here stated of reducing the 

burden on providers to account for 

patient actions while still continuing to 

encourage IT supported patient 

engagement. 

• Secure Electronic Messaging Using 

CEHRT 

++ Convert the measure for the Stage 

2 EP Secure Electronic Messaging 

objective from the 5 percent threshold to 

a yes/no attestation to the statement: 

‘‘The capability for patients to send and 

receive a secure electronic message was 

enabled during the EHR reporting 

period’’. 

These changes are reflected in the 

discussion of these objectives in section 

II.B.2. of this proposed rule. We note 

that these changes are intended to allow 

providers to work toward meaningful 

patient engagement through health IT 

using the methods best suited to their 

practice and their patient population. 

We further note that the Stage 3 

proposed rule includes an objective 

exclusively focused on patient 

engagement with an expanded set of 

measures and increased thresholds 

which providers would be required to 

meet beginning in 2018 (and optionally 

in 2017). (For further information on 

that proposed objective, we direct 

readers to 80 FR 16755 through 16758.) 

We invite public comment on this 

proposal. 

2. Meaningful Use Objectives and 

Measures for 2015, 2016, and 2017 

We propose the following objectives 

and measures for EPs, eligible hospitals, 

and CAHs to successfully demonstrate 

meaningful use for an EHR reporting 

period in 2015 through 2017. We note 

that there are 9 proposed objectives for 

EPs plus one consolidated public health 

reporting objective, and 8 proposed 

objectives for eligible hospitals and 

CAHs plus one consolidated public 

health reporting objective which would 

be required with alternate exclusions for 

certain providers in 2015 and which 

would be mandatory for all providers 

for an EHR reporting period beginning 

in 2016. 

a. Protect Electronic Health Information 

We are proposing to retain with 

certain modifications the Stage 2 

objective and measure for Protect 

Electronic Health Information for 

meaningful use in 2015 through 2017. 

(For further information and discussion 

of the existing Stage 2 Protect Electronic 

Health Information objective and 

measure, please refer to 77 FR 54002 

and 54003). 

Proposed Objective: Protect electronic 

health information created or 

maintained by the CEHRT through the 

implementation of appropriate technical 

capabilities. 

In the Stage 2 final rule (77 FR 54002 

through 54003), we discussed the 

benefits of safeguarding electronic 

protected health information (ePHI), as 

doing so is essential to all other aspects 

of meaningful use. Unintended and 

unlawful disclosures (or both) of ePHI 

could diminish consumers’ confidence 

in EHRs and health information 

exchange. Ensuring that ePHI is 

adequately protected and secured would 

assist in addressing the unique risks and 

challenges that may be presented by 

electronic health records. 

Proposed Measure: Conduct or review 

a security risk analysis in accordance 

with the requirements in 45 CFR 

164.308(a)(1), including addressing the 

security (to include encryption) of data 

stored in Certified EHR Technology in 

accordance with requirements in 45 

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

164.306(d)(3), and implement security 

updates as necessary and correct 

identified security deficiencies as part 

of the EP, eligible hospital, or CAHs risk 

management process. 

A review must be conducted for each 

EHR reporting period and any security 

updates and deficiencies that are 

identified should be included in the 

provider’s risk management process and 

implemented or corrected as dictated by 

that process. We refer providers to the 

requirements in 45 CFR 164.308(a)(1), 

including addressing the security (to 

include encryption) of data at rest in 

accordance with requirements in 45 

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

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

Rule for compliance. The HHS Office for 

Civil Rights (OCR) has issued guidance 

on conducting a security risk analysis in 

accordance with the HIPAA Security 

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

hipaa/administrative/securityrule/

rafinalguidancepdf.pdf). Other free tools 

and resources available to assist 

providers include a Security Risk 

Assessment (SRA) Tool developed by 

ONC and OCR http://www.healthit.gov/ 

providers-professionals/security-riskassessment-tool. 

The scope of the security risk analysis 

for purposes of this meaningful use 

measure applies to ePHI created or 

maintained by CEHRT. However, we 

note that other ePHI may be subject to 

the HIPPA Rules and we refer providers 

to those rules for additional security 

requirements. 

We invite public comment on this 

proposal. 

b. Clinical Decision Support 

We are proposing to retain the Stage 

2 objective and measures for Clinical 

Decision Support (CDS) for meaningful 

use in 2015 through 2017. This is a 

consolidated objective, which 

incorporates the Stage 1 objective to 

implement drug-drug and drug-allergy 

interaction checks. (For further 

information and discussion of the 

existing consolidated Stage 2 CDS 

objective and measures, please refer to 

77 FR 53995 through 53998.) 

Proposed Objective: Use clinical 

decision support to improve 

performance on high-priority health 

conditions. 

We propose to retain the Stage 2 

clinical decision support (CDS) 

objective such that CDS would be used 

to improve performance on high-priority 

health conditions. It would be left to the 

provider’s clinical discretion to select 

the most appropriate CDS interventions 

for his or her patient population. CDS 

interventions selected should be related 

to four or more of the clinical quality 

measures (CQMs) on which providers 

would be expected to report. The goal 

of the proposed CDS objective is for 

providers to implement improvements 

in clinical performance for high-priority 

health conditions that would result in 

improved patient outcomes. We propose 

to maintain that 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. 

Proposed Measure: In order for EPs, 

eligible hospitals, and CAHs to meet the 

objective they must satisfy both of the 

following measures: 

• Measure 1: Implement five clinical 

decision support interventions related 

to four or more clinical quality measures 

at a relevant point in patient care for the 

entire EHR reporting period. Absent 

four clinical quality measures related to 

an EP, eligible hospital or CAH’s scope 

of practice or patient population, the 

clinical decision support interventions 

must be related to high-priority health 

conditions. 

• Measure 2: The EP, eligible 

hospital, or CAH has enabled and 

implemented the functionality for drugdrug and drug allergy interaction checks 

for the entire EHR reporting period. 

For the first measure, it is suggested 

that one of the five clinical decision 

support interventions be related to 

improving healthcare efficiency. 

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Exclusion: For the second measure, 

any EP who writes fewer than 100 

medication orders during the EHR 

reporting period. 

Alternate Exclusions and Specifications 

for Stage 1 Providers for Meaningful Use 

in 2015 

We propose that providers who are 

scheduled to demonstrate Stage 1 of 

meaningful use for an EHR reporting 

period in 2015 may attest to meaningful 

use using the specifications established 

for the Stage 1 objectives and measures 

as they are currently defined at 42 CFR 

495.6 for each retained objective or 

measure where there is a difference in 

specifications between Stages 1 and 2. 

We note that the Stage 1 Clinical 

Decision Support objective has a 

different requirement than the Stage 2 

Clinical Decision Support objective 

measure 1 defined previously. For Stage 

1, the objective reads ‘‘Implement one 

clinical decision support rule relevant 

to specialty or high clinical priority 

along with the ability to track 

compliance with that rule’’ for EPs and 

‘‘Implement one clinical decision 

support rule related to a high priority 

hospital condition along with the ability 

to track compliance with that rule’’ for 

eligible hospitals and CAHs (42 CFR 

495.6). Therefore, for an EHR reporting 

period in 2015 only, we propose that an 

EP, eligible hospital or CAH who is 

scheduled to participate in Stage 1 in 

2015 may satisfy the following Stage 1 

measure instead of the Stage 2 measure 

1 stated previously: 

• Alternate Objective and Measure 

(For Measure 1): Objective: Implement 

one clinical decision support rule 

relevant to specialty or high clinical 

priority, or high priority hospital 

condition, along with the ability to track 

compliance with that rule. Measure: 

Implement one clinical decision support 

rule. 

We propose that for an EHR reporting 

period in 2015, an EP, eligible hospital 

or CAH who is scheduled to participate 

in Stage 1 in 2015 must also satisfy the 

Stage 2 measure 2 previously stated 

because it is the same as an existing 

Stage 1 measure (77 FR 53998). There 

are no alternate exclusions for this 

objective. 

We invite public comment on this 

proposal. 

c. Computerized Provider Order Entry 

(CPOE) 

We are proposing to retain the Stage 

2 objective and measures for 

Computerized Provider Order Entry 

(CPOE) for meaningful use in 2015 

through 2017, with the modifications 

proposed here as alternate exclusions 

and specifications for Stage 1 providers 

for an EHR reporting period in 2015. 

(For further information and discussion 

of the existing Stage 2 CPOE objective 

and measures, please refer to 77 FR 

53985 through 53987.) 

Proposed Objective: Use 

computerized provider order entry for 

medication, laboratory, and radiology 

orders directly entered by any licensed 

healthcare professional who can enter 

orders into the medical record per state, 

local, and professional guidelines. 

We define CPOE as entailing the 

provider’s use of computer assistance to 

directly enter medical orders (for 

example, medications, consultations 

with other providers, laboratory 

services, imaging studies, and other 

auxiliary services) from a computer or 

mobile device. The order is then 

documented or captured in a digital, 

structured, and computable format for 

use in improving safety and efficiency 

of the ordering process. CPOE improves 

quality and safety by allowing clinical 

decision support at the point of the 

order and therefore influences the initial 

order decision. CPOE improves safety 

and efficiency by automating aspects of 

the ordering process to reduce the 

possibility of communication and other 

errors. 

Proposed Measures: In Stage 2 of 

meaningful use, we adopted three 

measures for this objective: 

• Measure 1: More than 60 percent of 

medication orders created by the EP or 

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. 

• Measure 2: More than 30 percent of 

laboratory orders created by the EP or 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. 

• Measure 3: More than 30 percent of 

radiology orders created by the EP or 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. We propose to retain the 

three measures of this current Stage 2 

objective to calculate a percentage 

threshold for all three types of orders: 

Medication, laboratory, and radiology. 

We propose to retain exclusionary 

criteria for those providers who so 

infrequently issue an order type that it 

is not practical to implement CPOE for 

that order type. To calculate the 

percentage, CMS and ONC have worked 

together to define the following for this 

objective: 

• Measure 1: 

Denominator: Number of medication 

orders created by the EP or authorized 

providers in the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period. 

Numerator: The number of orders in 

the denominator recorded using CPOE. 

Threshold: The resulting percentage 

must be more than 60 percent in order 

for an EP, eligible hospital or CAH to 

meet this measure. 

Exclusion: Any EP who writes fewer 

than 100 medication orders during the 

EHR reporting period. 

• Measure 2: 

Denominator: Number of laboratory 

orders created by the EP or authorized 

providers in the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period. 

Numerator: The number of orders in 

the denominator recorded using CPOE. 

Threshold: The resulting percentage 

must be more than 30 percent in order 

for an EP, eligible hospital or CAH to 

meet this measure. 

Exclusion: Any EP who writes fewer 

than 100 laboratory orders during the 

EHR reporting period. 

• Measure 3: 

Denominator: Number of radiology 

orders created by the EP or authorized 

providers in the eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) during the 

EHR reporting period. 

Numerator: The number of orders in 

the denominator recorded using CPOE. 

Threshold: The resulting percentage 

must be more than 30 percent in order 

for an EP, eligible hospital or CAH to 

meet this measure. 

Exclusion: Any EP who writes fewer 

than 100 radiology orders during the 

EHR reporting period. 

An EP through a combination of 

meeting the thresholds and exclusions 

(or both) must satisfy all three measures 

for this objective. A hospital must meet 

the thresholds for all three measures. 

Alternate Exclusions and Specifications 

for Stage 1 Providers for Meaningful Use 

in 2015 

We propose that providers who are 

scheduled to demonstrate Stage 1 of 

meaningful use for an EHR reporting 

period in 2015 may attest to meaningful 

use using the specifications and 

thresholds established for the Stage 1 

objectives and measures as they are 

currently defined at 42 CFR 495.6 for 

each retained objective or measure 

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where there is a difference in 

specifications between Stages 1 and 2. 

In the Stage 1 final rule, the CPOE 

measure requires that ‘‘More than 30 

percent of all unique patients with at 

least one medication in their medication 

list seen by the EP or admitted to the 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period have at 

least one medication order entered 

using CPOE’’ (75 FR 44334). In addition, 

in the Stage 2 final rule, we established 

an optional alternative to this measure 

for Stage 1 of ‘‘More than 30 percent of 

medication orders created by the EP or 

authorized providers of the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period are 

recorded using CPOE.’’ (77 FR 53988). 

Therefore, we are proposing that for an 

EHR reporting period in 2015, providers 

scheduled to demonstrate Stage 1 of 

meaningful use may attest to the 

specification associated with the Stage 1 

measure. 

We further propose that providers 

scheduled to demonstrate Stage 1 of 

meaningful use for an EHR reporting 

period in 2015 may claim an exclusion 

for any retained Stage 2 measure where 

there is not an equivalent Stage 1 

measure currently defined at 42 CFR 

495.6. The Stage 2 CPOE objective 

includes measures for laboratory and 

radiology orders, whereas the Stage 1 

CPOE objective does not include these 

measures. Thus, we propose that for an 

EHR reporting period in 2015 only, 

providers scheduled to demonstrate 

Stage 1 of meaningful use in 2015 may 

exclude the Stage 2 CPOE measures for 

laboratory and radiology orders 

(measures 2 and 3 listed previously). We 

propose that for an EHR reporting 

period beginning in 2016, all providers 

must attest to the Stage 2 objective and 

measures, and meet the thresholds 

associated with all three of the Stage 2 

measures discussed previously in order 

to successfully demonstrate meaningful 

use. 

Alternate Measure 1: More than 30 

percent of all unique patients with at 

least one medication in their medication 

list seen by the EP or admitted to the 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period have at 

least one medication order entered 

using CPOE; or more than 30 percent of 

medication orders created by the EP 

during the EHR reporting period, or 

created by the authorized providers of 

the eligible hospital or CAH for patients 

admitted to their inpatient or emergency 

departments (POS 21 or 23) during the 

EHR reporting period, are recorded 

using computerized provider order 

entry. 

Alternate Exclusion for Measure 2: 

Provider may claim an exclusion for 

measure 2 (laboratory orders) of the 

Stage 2 CPOE objective for an EHR 

reporting period in 2015. 

Alternate Exclusion for Measure 3: 

Provider may claim an exclusion for 

measure 3 (radiology orders) of the 

Stage 2 CPOE objective for an EHR 

reporting period in 2015. 

We invite public comment on this 

proposal. 

d. Electronic Prescribing 

We are proposing to retain the Stage 

2 objective and measure for Electronic 

Prescribing (eRx) for EPs as well as for 

eligible hospitals and CAHs for 

meaningful use in 2015 through 2017. 

We note that the Stage 2 objective for 

eligible hospitals and CAHs is currently 

a menu objective, but we propose it 

would be required for 2015 through 

2017, with an exception for Stage 1 

eligible hospitals and CAHs for an EHR 

reporting period in 2015. (For further 

information and discussion of the 

existing Stage 2 eRx objectives and 

measures, please refer to 77 FR 53989 

through 53990 for EPs and 77 FR 54035 

through 54036 for eligible hospitals and 

CAHs.) 

(1) EP Proposed Objective 

Proposed EP Objective: Generate and 

transmit permissible prescriptions 

electronically (eRx). 

The use of electronic prescribing has 

several advantages over having the 

patient carry the prescription to the 

pharmacy or directly faxing a 

handwritten or typewritten prescription 

to the pharmacy. When the EP generates 

the prescription electronically, CEHRT 

can recognize the information and can 

provide decision support to promote 

safety and quality in the form of adverse 

interactions and other treatment 

possibilities. The CEHRT can also 

provide decision support that promotes 

the efficiency of the health care system 

by alerting the EP to generic alternatives 

or to alternatives favored by the 

patient’s insurance plan that are equally 

effective. Transmitting the prescription 

electronically promotes efficiency and 

safety through reduced communication 

errors. It also allows the pharmacy or a 

third party to automatically compare the 

medication order to others they have 

received for the patient. This 

comparison allows for many of the same 

decision support functions enabled at 

the generation of the prescription, but 

bases them on potentially greater 

information. 

Proposed EP Measure: More than 50 

percent of all permissible prescriptions, 

or all prescriptions, written by the EP 

are queried for a drug formulary and 

transmitted electronically using 

Certified EHR Technology. 

We propose to retain the exclusion 

introduced for Stage 2 that would allow 

EPs to exclude this objective if no 

pharmacies within 10 miles of an EP’s 

practice location at the start of his/her 

EHR reporting period accept electronic 

prescriptions. This is 10 miles in any 

straight line from the practice location 

independent of the travel route from the 

practice location to the pharmacy. We 

stated that EPs practicing at multiple 

locations would be eligible for the 

exclusion if any of their practice 

locations that are equipped with CEHRT 

meet this criteria. An EP would not be 

eligible for this exclusion if he or she is 

part of an organization that owns or 

operates its own pharmacy within the 

10 mile radius regardless of whether 

that pharmacy can accept electronic 

prescriptions from EPs outside of the 

organization. 

We also propose to retain the 

exclusion for EPs who write fewer than 

100 permissible prescriptions during the 

EHR reporting period. 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

Denominator: Number of 

prescriptions written for drugs requiring 

a prescription in order to be dispensed 

other than controlled substances during 

the EHR reporting period; or Number of 

prescriptions written for drugs requiring 

a prescription in order to be dispensed 

during the EHR reporting period. 

Numerator: The number of 

prescriptions in the denominator 

generated, queried for a drug formulary 

and transmitted electronically using 

CEHRT. 

Threshold: The resulting percentage 

must be more than 50 percent in order 

for an EP to meet this measure. 

Exclusions: Any EP who: 

• Writes fewer than 100 permissible 

prescriptions during the EHR reporting 

period; or 

• Does not have a pharmacy within 

his or her 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. 

Alternate Exclusions and Specifications 

for Stage 1 Providers for Meaningful Use 

in 2015 

We propose that providers who are 

scheduled to demonstrate Stage 1 of 

meaningful use for an EHR reporting 

period in 2015 may attest to meaningful 

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use using the specifications established 

for the Stage 1 objectives and measures 

as they are currently defined at 42 CFR 

495.6 for each retained objective or 

measure where there is a difference in 

specifications between Stages 1 and 2. 

In Stage 1, the electronic prescribing 

measure for EPs requires that ‘‘More 

than 40 percent of all permissible 

prescriptions written by the EP are 

transmitted electronically using 

certified EHR technology’’ (75 FR 

44338). 

Therefore, we are proposing that for 

an EHR reporting period in 2015, EPs 

scheduled to demonstrate Stage 1 of 

meaningful use may attest to the 

specifications and threshold associated 

with the Stage 1 measure. We note that 

for an EHR reporting period beginning 

in 2016, all EPs must meet the 

specifications and threshold for the 

retained Stage 2 measure in order to 

successfully demonstrate meaningful 

use. 

Alternate EP Measure: More than 40 

percent of all permissible prescriptions 

written by the EP are transmitted 

electronically using Certified EHR 

Technology. 

There are no alternate exclusions for 

this EP objective. 

(2) Eligible Hospital/CAH Proposed 

Objective 

Proposed Eligible Hospital/CAH 

Objective: Generate and transmit 

permissible discharge prescriptions 

electronically (eRx). 

In the Stage 2 final rule at 77 FR 

54035, we describe that the use of 

electronic prescribing has several 

advantages over having the patient carry 

the prescription to the pharmacy or 

directly faxing a handwritten or 

typewritten prescription to the 

pharmacy. When the hospital generates 

the prescription electronically, CEHRT 

can provide support for a number of 

purposes such as promoting safety and 

quality in the form of decision support 

around adverse interactions and other 

treatment possibilities; increasing the 

efficiency of the health care system by 

alerting the EP to generic alternatives or 

to alternatives favored by the patient’s 

insurance plan that are equally effective; 

and reducing communication errors by 

allows the pharmacy or a third party to 

automatically compare the medication 

order to others they have received for 

the patient. This allows for many of the 

same decision support functions 

enabled at the generation of the 

prescription, but with access to 

potentially greater information. For this 

reason, we continue to support the use 

of electronic prescribing for discharge 

prescriptions in a hospital setting. 

Proposed Eligible Hospital/CAH 

Measure: More than 10 percent of 

hospital discharge medication orders for 

permissible prescriptions (for new, 

changed and refilled prescriptions) are 

queried for a drug formulary and 

transmitted electronically using 

Certified EHR Technology. 

We propose to retain the exclusion 

that would allow a hospital to exclude 

this objective if there is no internal 

pharmacy that can accept electronic 

prescriptions and is not located within 

10 miles of any pharmacy that accepts 

electronic prescriptions at the start of 

their EHR reporting period. 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

Denominator: Number of new, 

changed, or refill prescriptions written 

for drugs requiring a prescription in 

order to be dispensed other than 

controlled substances for patients 

discharged during the EHR reporting 

period. 

Numerator: The number of 

prescriptions in the denominator 

generated, queried for a drug formulary 

and transmitted electronically. 

Threshold: The resulting percentage 

must be more than 10 percent in order 

for an eligible hospital or CAH to meet 

this measure. 

Exclusion: Any eligible hospital or 

CAH that does not have an internal 

pharmacy that can accept electronic 

prescriptions and is not located within 

10 miles of any pharmacy that accepts 

electronic prescriptions at the start of 

their EHR reporting period. 

Alternate Exclusions and Specifications 

for Stage 1 Providers for Meaningful Use 

in 2015 

We propose that eligible hospitals and 

CAHs scheduled to report on Stage 1 

objectives for an EHR reporting period 

in 2015 may claim an exclusion for the 

Stage 2 eRx measure as there is not an 

equivalent Stage 1 measure defined at 

42 CFR 495.6. We further propose that 

eligible hospitals and CAHs scheduled 

to report Stage 2 objectives for an EHR 

reporting period in 2015 who were not 

intending to attest to the eRx menu 

objective and measure may also claim 

an exclusion. We note that for an EHR 

reporting period beginning in 2016, all 

providers must attest to the objective 

and measure and meet the specifications 

and threshold for the Stage 2 measure in 

order to successfully demonstrate 

meaningful use. 

Alternate Eligible Hospital/CAH 

Exclusion: Provider may claim an 

exclusion for the eRx objective and 

measure if for an EHR reporting period 

in 2015 they were either scheduled to 

demonstrate Stage 1 which does not 

have an equivalent measure, or if they 

are scheduled to demonstrate Stage 2 

but did not intend to select the Stage 2 

eRx menu objective for an EHR 

reporting period in 2015. 

There are no alternate specifications 

for this eligible hospital and CAH 

objective. 

We invite public comment on this 

proposal. 

e. Summary of Care 

We are proposing to retain only the 

second measure of the existing Stage 2 

objective for Summary of Care for 

meaningful use in 2015 through 2017 

with the modifications discussed in this 

proposed rule. (For further information 

and discussion of the existing Stage 2 

Summary of Care objective and 

measures, we refer readers to the 

discussion in the Stage 2 final rule at 77 

FR 54013 through 54021.) 

Proposed Objective: The EP, eligible 

hospital or CAH who transitions their 

patient to another setting of care or 

provider of care or refers their patient to 

another provider of care provides a 

summary care record for each transition 

of care or referral. 

In the Stage 2 final rule, we outlined 

the following benefits of this objective. 

By assuring lines of communication 

between providers caring for the same 

patient, all of the providers of care can 

operate with better information and 

more effectively coordinate the care 

they provide. Electronic health records, 

especially when linked directly or 

through health information exchanges, 

reduce the burden of such 

communication. The purpose of this 

objective is to ensure a summary of care 

record is provided to the receiving 

provider when a patient is transitioning 

to a new provider or has been referred 

to another provider while remaining in 

the care of the referring provider. 

Proposed Measure: The EP, eligible 

hospital or CAH that transitions or 

refers their patient to another setting of 

care or provider of care that—(1) uses 

CEHRT to create a summary of care 

record; and (2) electronically transmits 

such summary to a receiving provider 

for more than 10 percent of transitions 

of care and referrals. 

We are proposing to retain an updated 

version of the second measure of the 

Stage 2 Summary of Care objective with 

modifications based on guidance 

provided through CMS responses to 

frequently asked questions we have 

received since the publication of the 

Stage 2 final rule. We are proposing to 

retain this measure for electronic 

transmittal because we believe that the 

electronic exchange of health 

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information between providers would 

encourage the sharing of the patient care 

summary from one provider to another 

and the communication of important 

information that the patient may not 

have been able to provide, which can 

significantly improve the quality and 

safety of referral care and reduce 

unnecessary and redundant testing. Use 

of common standards in creating the 

summary of care record can 

significantly reduce the cost and 

complexity of interfaces between 

different systems and promote 

widespread exchange and 

interoperability. 

The proposed updates to this measure 

reflect stakeholder input regarding 

operational challenges in meeting this 

measure, and seek to increase flexibility 

for providers while continuing to drive 

interoperability across care settings and 

encouraging further innovation. 

Currently, the measure specifies the 

manner in which the summary of care 

must be electronically transmitted. 

Providers must either—(1) electronically 

transmit the summary of care using 

CEHRT to a recipient; or (2) where the 

recipient receives the summary of care 

record via exchange facilitated by an 

organization that is a NwHIN Exchange 

participant or in a manner that is 

consistent with the governance 

mechanism ONC establishes for the 

nationwide health information network. 

We propose to update this measure to 

state simply that a provider would be 

required to create the summary of care 

record using CEHRT and transmit the 

summary of care record electronically. 

To calculate the percentage of the 

measure, CMS and ONC have worked 

together to define the following for this 

objective: 

Denominator: Number of transitions 

of care and referrals during the EHR 

reporting period for which the EP or 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

was the transferring or referring 

provider. 

Numerator: The number of transitions 

of care and referrals in the denominator 

where a summary of care record was 

created using Certified EHR Technology 

and is exchanged electronically. 

Threshold: The percentage must be 

more than 10 percent in order for an EP, 

eligible hospital or CAH to meet this 

measure. 

Exclusion: Any EP who transfers a 

patient to another setting or refers a 

patient to another provider less than 100 

times during the EHR reporting period. 

Alternate Exclusions and Specifications 

for Stage 1 Providers for Meaningful Use 

in 2015 

We propose that providers scheduled 

to demonstrate Stage 1 of meaningful 

use for an EHR reporting period in 2015 

may claim an exclusion for Measure 2 

of the Stage 2 Summary of Care core 

objective, as there is not an equivalent 

Stage 1 measure. The measure related to 

the electronic transmission of a 

summary of care record in the Summary 

of Care core objective requires an 

electronic summary of care document to 

be sent for transitions and referrals and 

is only applicable for Stage 2. There is 

not an equivalent objective and measure 

in Stage 1. We note that for an EHR 

reporting period beginning in 2016, all 

providers must attest to the complete 

objective and meet the specifications 

and threshold for the both Stage 2 

measures in order to successfully 

demonstrate meaningful use. 

Alternate Exclusion: Provider may 

claim an exclusion for the measure of 

the Stage 2 Summary of Care objective 

which requires the electronic 

transmission of a summary of care 

document if for an EHR reporting period 

in 2015 they were scheduled to 

demonstrate Stage 1, which does not 

have an equivalent measure. 

There are no alternate specifications 

for this objective. 

We invite public comment on this 

proposal. 

f. Patient Specific Education 

We are proposing to retain the Stage 

2 objective and measure for Patient 

Specific Education for meaningful use 

for 2015 through 2017. (For further 

information and discussion of the 

existing Stage 2 Patient Specific 

Education objective and measure, please 

refer to 77 FR 54011 and 54012.) 

Proposed Objective: Use clinically 

relevant information from Certified EHR 

Technology to identify patient-specific 

education resources and provide those 

resources to the patient. 

In the Stage 2 proposed rule, we 

explained that providing clinically 

relevant education resources to patients 

is a priority for the meaningful use of 

CEHRT. While CEHRT must be used to 

identify patient-specific education 

resources, these resources or materials 

do not have to be stored within or 

generated by the CEHRT. We are aware 

that there are many electronic resources 

available for patient education 

materials, such as through the National 

Library of Medicine’s MedlinePlus 

(http://www.nlm.nih.gov/medlineplus, 

that can be queried via CEHRT (that is, 

specific patient characteristics are 

linked to specific consumer health 

content). The EP or hospital should 

utilize CEHRT in a manner where the 

technology suggests patient-specific 

educational resources based on the 

information stored in the CEHRT. 

Certified EHR technology is certified to 

use the patient’s problem list, 

medication list, or laboratory test results 

to identify the patient-specific 

educational resources. The EP or 

hospital may use these elements or 

additional elements within CEHRT to 

identify educational resources specific 

to patients’ needs. The EP or hospital 

can then provide these educational 

resources to patients in a useful format 

for the patient (such as, electronic copy, 

printed copy, electronic link to source 

materials, through a patient portal or 

PHR). 

Proposed EP Measure: Patient-specific 

education resources identified by 

Certified EHR Technology are provided 

to patients for more than 10 percent of 

all unique patients with office visits 

seen by the EP during the EHR reporting 

period. 

We propose to retain the exclusion for 

EPs who have no office visits in order 

to accommodate such EPs. 

The resources would have to be those 

identified by CEHRT. If resources are 

not identified by CEHRT and provided 

to the patient then it would not count 

in the numerator. We do not intend 

through this requirement to limit the 

education resources provided to patient 

to only those identified by CEHRT. The 

education resources would need to be 

provided prior to the calculation and 

subsequent attestation to meaningful 

use. 

To calculate the percentage for EPs, 

CMS and ONC have worked together to 

define the following for this objective: 

Denominator: Number of unique 

patients with office visits seen by the EP 

during the EHR reporting period. 

Numerator: Number of patients in the 

denominator who were provided 

patient-specific education resources 

identified by the Certified EHR 

Technology. 

Threshold: The resulting percentage 

must be more than 10 percent in order 

for an EP to meet this measure. 

Exclusion: Any EP who has no office 

visits during the EHR reporting period. 

Proposed Eligible Hospital/CAH 

Measure: More than 10 percent of all 

unique patients admitted to the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

are provided patient specific education 

resources identified by Certified EHR 

Technology. 

To calculate the percentage for 

hospitals, CMS and ONC have worked 

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together to define the following for this 

objective: 

Denominator: Number of unique 

patients admitted to the eligible hospital 

or CAH inpatient or emergency 

departments (POS 21 or 23) during the 

EHR reporting period. 

Numerator: Number of patients in the 

denominator who are subsequently 

provided patient-specific education 

resources identified by CEHRT. 

Threshold: The resulting percentage 

must be more than 10 percent in order 

for an eligible hospital or CAH to meet 

this measure. 

Alternate Exclusions and Specifications 

for Stage 1 Providers for Meaningful Use 

in 2015 

While the Patient Specific Education 

objective is designated as an optional 

menu objective in Stage 1 of meaningful 

use, the same objective is a mandatory 

core objective in Stage 2 of meaningful 

use. We expect that not all Stage 1 

scheduled providers were planning to 

choose this menu objective when 

attesting in an EHR reporting period in 

2015. Therefore, we propose that any 

provider scheduled to demonstrate 

Stage 1 of meaningful use for an EHR 

reporting period in 2015 who was not 

intending to attest to the Stage 1 Patient 

Specific Education menu objective, may 

claim an exclusion to the measure. We 

note that for an EHR reporting period 

beginning in 2016, all providers must 

attest to the objective and measure and 

meet the Stage 2 specifications and 

threshold in order to successfully 

demonstrate meaningful use. 

Alternate Exclusion: Provider may 

claim an exclusion for the measure of 

the Stage 2 Patient Specific Education 

objective if for an EHR reporting period 

in 2015 they were scheduled to 

demonstrate Stage 1 but did not intend 

to select the Stage 1 Patient Specific 

Education menu objective. 

There are no alternate specifications 

for this objective. 

We invite public comment on this 

proposal. 

g. Medication Reconciliation 

We are proposing to retain the Stage 

2 objective and measure for Medication 

Reconciliation for meaningful use in 

2015 through 2017. (For further 

information and discussion of the 

existing Stage 2 Medication 

Reconciliation objective and measure, 

please refer to 77 FR 54012 and 54013.) 

Proposed Objective: The EP, eligible 

hospital or CAH who receives a patient 

from another setting of care or provider 

of care or believes an encounter is 

relevant should perform medication 

reconciliation. 

Medication reconciliation allows 

providers to confirm that the 

information they have on the patient’s 

medication is accurate. This not only 

assists the provider in his or her direct 

patient care, it also improves the 

accuracy of information they provide to 

others through health information 

exchange. 

In the Stage 2 proposed rule, we noted 

that that when conducting medication 

reconciliation during a transition of 

care, the EP, eligible hospital or CAH 

that receives the patient into their care 

should conduct the medication 

reconciliation. We reiterated that the 

measure of this objective does not 

dictate what information must be 

included in medication reconciliation. 

Information included in the process of 

medication reconciliation is 

appropriately determined by the 

provider and patient. We defined 

medication reconciliation as the process 

of identifying the most accurate list of 

all medications that the patient is 

taking, including name, dosage, 

frequency, and route, by comparing the 

medical record to an external list of 

medications obtained from a patient, 

hospital or other provider. 

Proposed Measure: The EP, eligible 

hospital or CAH performs medication 

reconciliation for more than 50 percent 

of transitions of care in which the 

patient is transitioned into the care of 

the EP or admitted to the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23). 

For the purposes of this measure, we 

propose to maintain the definition of a 

transition of care as the movement of a 

patient from one setting of care (for 

example, a hospital, ambulatory primary 

care practice, ambulatory specialty care 

practice, long-term care, home health, 

rehabilitation facility) to another and 

referrals are cases where one provider 

refers a patient to another, but the 

referring provider maintains his or her 

care of the patient as well. 

To calculate the percentage, CMS and 

ONC have worked together to define the 

following for this objective: 

Denominator: Number of transitions 

of care during the EHR reporting period 

for which the EP or eligible hospital’s or 

CAH’s inpatient or emergency 

department (POS 21 or 23) was the 

receiving party of the transition. 

Numerator: The number of transitions 

of care in the denominator where 

medication reconciliation was 

performed. 

Threshold: The resulting percentage 

must be more than 50 percent in order 

for an EP, eligible hospital or CAH to 

meet this measure. 

Exclusion: Any EP who was not the 

recipient of any transitions of care 

during the EHR reporting period. 

Alternate Exclusions and Specifications 

for Stage 1 Providers for Meaningful Use 

in 2015 

While the Medication Reconciliation 

objective is designated as an optional 

menu objective in Stage 1 of meaningful 

use, the same objective is a mandatory 

core objective in Stage 2 of meaningful 

use. We expect that not all Stage 1 

scheduled providers were planning to 

choose this menu objective when 

attesting in an EHR reporting period in 

2015. Therefore, we propose that any 

provider scheduled to demonstrate 

Stage 1 of meaningful use for an EHR 

reporting period in 2015 who was not 

intending to attest to the Stage 1 

Medication Reconciliation menu 

objective, may claim an exclusion to the 

measure. We note that for an EHR 

reporting period beginning in 2016, all 

providers must attest to the objective 

and measure and meet the Stage 2 

specifications and threshold in order to 

successfully demonstrate meaningful 

use. 

Alternate Exclusion: Provider may 

claim an exclusion for the measure of 

the Stage 2 Medication Reconciliation 

objective if for an EHR reporting period 

in 2015 they were scheduled to 

demonstrate Stage 1 but did not intend 

to select the Stage 1 Medication 

Reconciliation menu objective. 

There are no alternate specifications 

for this objective. 

We invite public comment on this 

proposal. 

h. Patient Electronic Access (VDT) 

We are proposing to retain the Stage 

2 objective for Patient Electronic Access 

for meaningful use in 2015 through 

2017. We are proposing to retain the 

first measure of the Stage 2 objective 

without modification. We are proposing 

to retain the second measure for the 

Stage 2 objective with modification to 

the measure threshold. (For further 

information and discussion of the 

existing Stage 2 Patient Electronic 

Access objective and measures, please 

refer to 77 FR 54007 through 54011.) 

Proposed EP Objective: Provide 

patients the ability to view online, 

download, and transmit their health 

information within 4 business days of 

the information being available to the 

EP. 

Proposed Eligible Hospital/CAH 

Objective: Provide patients the ability to 

view online, download, and transmit 

information about a hospital admission. 

In the Stage 2 proposed rule, we 

stated that the goal of this objective was 

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20364 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 

to allow patients easy access to their 

health information as soon as possible, 

so that they can make informed 

decisions regarding their care or share 

their most recent clinical information 

with other health care providers and 

personal caregivers as they see fit. 

The ability to have this information 

online means it is always retrievable by 

the patient, while the download 

function ensures that the patient can 

take the information with them when 

secure internet access is not available. 

The patient must be able to access this 

information on demand, such as 

through a patient portal or personal 

health record (PHR). We note that while 

a covered entity may be able to fully 

satisfy a patient’s request for 

information through VDT, the measure 

does not replace the covered entity’s 

responsibilities to meet the broader 

requirements under HIPAA to provide 

an individual, upon request, with access 

to PHI in a designated record set. 

Providers should also be aware that 

while meaningful use is limited to the 

capabilities of CEHRT to provide online 

access there may be patients who cannot 

access their EHRs electronically because 

of their disability. Additionally, other 

health information may not be 

accessible. Finally, we noted that 

providers who are covered by civil 

rights laws must provide individuals 

with disabilities equal access to 

information and appropriate auxiliary 

aids and services as provided in the 

applicable statutes and regulations. 

Proposed EP Measures 

• EP Measure 1: More than 50 percent 

of all unique patients seen by the EP 

during the EHR reporting period are 

provided timely (within 4 business days 

after the information is available to the 

EP) online access to their health 

information subject to the EP’s 

discretion to withhold certain 

information. 

• EP Measure 2: At least one patient 

seen by the EP during the EHR reporting 

period (or their authorized 

representatives) views, downloads, or 

transmits his or her health information 

to a third party. 

In order to meet this objective, the 

following information must be made 

available to patients electronically 

within 4 business days of the 

information being made available to the 

EP: 

++ Patient name. 

++ Provider’s name and office contact 

information. 

++ Current and past problem list. 

++ Procedures. 

++ Laboratory test results. 

++ Current medication list and 

medication history. 

++ Current medication allergy list and 

medication allergy history. 

++ Vital signs (height, weight, blood 

pressure, BMI, growth charts). 

++ Smoking status. 

++ Demographic information 

(preferred language, sex, race, ethnicity, 

date of birth). 

++ Care plan field(s), including goals 

and instructions. 

++ Any known care team members 

including the primary care provider 

(PCP) of record. 

As we stated in the Stage 2 proposed 

rule, this is not intended to limit the 

information made available by the EP. 

An EP can make available additional 

information and still align with the 

objective. In circumstances where there 

is no information available to populate 

one or more of the fields previously 

listed, either because the EP can be 

excluded from recording such 

information (for example, vital signs) or 

because there is no information to 

record (for example, no medication 

allergies or laboratory tests), the EP may 

have an indication that the information 

is not available and still meet the 

objective and its associated measure. 

Please note that while some of the 

information made available through this 

measure is similar to the information 

made available in the summary of care 

document that must be provided 

following transitions of care or referrals, 

the list of information provided is 

specific to the view online, download, 

and transmit objective. Patients and 

providers have different information 

needs and contexts, so we have 

established separate required fields for 

each of these objectives. 

We propose to retain the exclusion 

that any EP who neither orders nor 

creates any of the information listed for 

inclusion as part of this measure may 

exclude from this measure as well as the 

exclusion for limited broadband access 

in an EPs service area. 

To calculate the percentage of the first 

measure for providing patient with 

timely online access to health 

information, CMS and ONC have 

worked together to define the following 

for this objective: 

• EP Measure 1: More than 50 percent 

of all unique patients seen by the EP 

during the EHR reporting period are 

provided timely (within 4 business days 

after the information is available to the 

EP) online access to their health 

information subject to the EP’s 

discretion to withhold certain 

information. 

Denominator: Number of unique 

patients seen by the EP during the EHR 

reporting period. 

Numerator: The number of patients in 

the denominator who have timely 

(within 4 business days after the 

information is available to the EP) 

online access to their health 

information. 

Threshold: The resulting percentage 

must be more than 50 percent in order 

for an EP to meet this measure. 

• EP Measure 2: At least one patient 

seen by the EP during the EHR reporting 

period (or his or her authorized 

representatives) views, downloads, or 

transmits his or her health information 

to a third party. 

• Exclusions: Any EP who— 

(a) Neither orders nor creates any of 

the information listed for inclusion as 

part of the measures; or 

(b) Conducts 50 percent or more of his 

or her patient encounters in a county 

that does not have 50 percent or more 

of its housing units with 4Mbps 

broadband availability according to the 

latest information available from the 

FCC on the first day of the EHR 

reporting period. 

Proposed Eligible Hospital/CAH 

Measures: 

• Eligible Hospital/CAH Measure 1: 

More than 50 percent of all patients who 

are discharged from the inpatient or 

emergency department (POS 21 or 23) of 

an eligible hospital or CAH have their 

information available online within 36 

hours of discharge. 

• Eligible Hospital/CAH Measure 2: 

At least 1 patient who is discharged 

from the inpatient or emergency 

department (POS 21 or 23) of an eligible 

hospital or CAH (or his or her 

authorized representative) views, 

downloads, or transmits to a third party 

his or her information during the EHR 

reporting period. 

The following information must be 

available to satisfy the objective and 

measure: 

++ Patient name. 

++ Admit and discharge date and 

location. 

++ Reason for hospitalization. 

++ Care team including the attending 

of record as well as other providers of 

care. 

++ Procedures performed during 

admission. 

++ Current and past problem list. 

++ Vital signs at discharge. 

++ Laboratory test results (available at 

time of discharge). 

++ Summary of care record for 

transitions of care or referrals to another 

provider. 

++ Care plan field(s), including goals 

and instructions. 

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3Rosenberg SN, Shnaiden TL, Wegh AA, Juster 

IA (2008) ‘‘Supporting the patient’s role in 

guideline compliance: a controlled study’’ 

American Journal of Managed Care 14(11):737–44; 

Gustafson DH, Hawkins R, Boberg E, Pingree S, 

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

a patient-centered, computer-based health 

information/support system’’ American Journal of 

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

D, Reid R, Anderson M, Moran M, Hereford J (2007) 

‘‘Patient web services integrated with a shared 

medical record: patient use and satisfaction’’ 

Journal of the American Medical Informatics 

Association 14(6):798–806). 

++ Discharge instructions for patient. 

++ Demographics maintained by 

hospital (sex, race, ethnicity, date of 

birth, preferred language). 

++ Smoking status. 

This is not intended to limit the 

information made available by the 

hospital. A hospital can make available 

additional information and still align 

with the objective. Please note that 

while some of the information made 

available through this measure is similar 

to the information made available in the 

summary of care document that must be 

provided following transitions of care or 

referrals, this list of information 

provided is specific to the view online, 

download, and transmit objective. 

Patients and providers have different 

information needs and contexts, so CMS 

has established separate required fields 

for each of these objectives. 

To calculate the percentage of the first 

measure for providing patients timely 

access to discharge information, CMS 

and ONC have worked together to 

define the following for this objective: 

• Eligible Hospital/CAH Measure 1: 

More than 50 percent of all patients who 

are discharged from the inpatient or 

emergency department (POS 21 or 23) of 

an eligible hospital or CAH have their 

information available online within 36 

hours of discharge. 

Denominator: Number of unique 

patients discharged from an eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period. 

Numerator: The number of patients in 

the denominator whose information is 

available online within 36 hours of 

discharge. 

Threshold: The resulting percentage 

must be more than 50 percent in order 

for an eligible hospital or CAH to meet 

this measure. 

• Eligible Hospital/CAH Measure 2: 

At least 1 patient who is discharged 

from the inpatient or emergency 

department (POS 21 or 23) of an eligible 

hospital or CAH (or his or her 

authorized representative) views, 

downloads, or transmits to a third party 

his or her information during the EHR 

reporting period. 

• Exclusion: 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. 

Alternate Exclusions and Specifications 

for Stage 1 Providers for Meaningful Use 

in 2015 

The Patient Electronic Access 

objective has two associated measures, 

the first (provide access to view, 

download, and transmit health 

information) is applicable for both Stage 

1 and Stage 2 while the second (patients 

view, download, or transmit their health 

information) is only applicable for Stage 

2. Therefore, we propose that providers 

scheduled to demonstrate Stage 1 of 

meaningful use for an EHR reporting 

period in 2015 may additionally claim 

an exclusion for the second measure of 

the Stage 2 Patient Electronic Access 

objective as there is not an equivalent 

Stage 1 measure defined at 42 CFR 

495.6. We note that for an EHR reporting 

period beginning in 2016, all providers 

must attest to the objective and both 

measures and meet the specifications 

and threshold associated with the 

retained Stage 2 objective and measures 

in order to successfully demonstrate 

meaningful use. 

• Alternate Exclusion Measure 2: 

Provider may claim an exclusion for the 

second measure if for an EHR reporting 

period in 2015 they were scheduled to 

demonstrate Stage 1, which does not 

have an equivalent measure. 

There are no alternate specifications 

for this objective. 

We invite public comment on this 

proposal. 

i. Secure Electronic Messaging 

We are proposing to retain the Stage 

2 objective for secure electronic 

messaging with modifications to the 

measure for meaningful use in 2015 

through 2017. (For further information 

and discussion of the existing Stage 2 

secure electronic messaging objective 

and measure, please refer to 77 FR 

54033.) 

Proposed Objective: Use secure 

electronic messaging to communicate 

with patients on relevant health 

information. 

In the Stage 2 proposed rule, we 

outlined the following benefits of using 

secure electronic messaging to 

communicate with patients: Electronic 

messaging (for example, email) is one of 

the most widespread methods of 

communication for both businesses and 

individuals. The ability to communicate 

through forms of electronic messaging is 

essential to the provider-patient 

relationship. Electronic messaging is 

very inexpensive on a transactional 

basis and allows for communication 

even when the provider and patient are 

not available at the same moment in 

time. However, common email services 

may not be secure enough to be 

appropriate for the exchange of ePHI. 

Therefore, the exchange of ePHI through 

electronic messaging requires additional 

security measures while maintaining its 

ease of use for communication. While 

secure email with the necessary 

safeguards is probably the most widely 

used method of electronic messaging, 

for the purposes of meeting this 

objective, secure electronic messaging 

could also occur through functionalities 

of patient portals, PHRs, or other standalone secure messaging applications. 

For EPs, secure electronic messaging 

is critically important to two National 

Quality Strategy (NQS) priorities— 

• Ensuring that each person/family is 

engaged as partners in their care; and 

• Promoting effective communication 

and coordination of care. 

Secure electronic messaging could 

make care more affordable by using 

more efficient communication vehicles 

when appropriate. Specifically, research 

demonstrates that secure messaging has 

improved patient adherence to 

treatment plans, which reduces 

readmission rates. In addition, secure 

messaging has led to increased patient 

satisfaction with their care and is one of 

the top ranked features according to 

patients. In addition, despite some 

trepidation, providers have seen a 

reduction in time responding to 

inquiries and less time spent on the 

phone.3

Proposed Measure: During the EHR 

reporting period, the capability for 

patients to send and receive a secure 

electronic message with the provider 

was fully enabled. 

We propose to retain the exclusion for 

EPs who have no office visits, and for 

those EPs who lack the infrastructure 

required for secure electronic messaging 

due to being located in areas with 

limited broadband availability as 

identified by the FCC. 

Measure: During the EHR reporting 

period, the capability for patients to 

send and receive a secure electronic 

message with the provider was fully 

enabled. 

Exclusion: Any EP who has no office 

visits during the EHR reporting period, 

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or any EP who conducts 50 percent or 

more of his or her patient encounters in 

a county that does not have 50 percent 

or more of its housing units with 4Mbps 

broadband availability according to the 

latest information available from the 

FCC on the first day of the EHR 

reporting period. 

Alternate Exclusions and Specifications 

for Stage 1 Providers for Meaningful Use 

in 2015 

For the secure electronic messaging 

objective, there is no Stage 1 objective 

or measure which relates to the 

requirements of the Stage 2 objective 

and measure. We therefore propose that 

an EP scheduled to demonstrate Stage 1 

of meaningful use for an EHR reporting 

period in 2015 may claim an exclusion 

for the secure electronic messaging 

objective measure as there is not an 

equivalent Stage 1 objective or measure 

defined at 42 CFR 495.6. We note that 

for an EHR reporting period beginning 

in 2016, all providers must attest to the 

objective and measure of the retained 

Stage 2 secure electronic messaging 

objective in order to successfully 

demonstrate meaningful use. 

• Alternate Exclusion: An EP may 

claim an exclusion for the measure if for 

an EHR reporting period in 2015 they 

were scheduled to demonstrate Stage 1, 

which does not have an equivalent 

measure. 

There are no alternate specifications 

for this objective and there is no 

equivalent objective for eligible 

hospitals and CAHs in the Stage 2 

objectives and measures for meaningful 

use. 

We invite public comment on this 

proposal. 

j. Public Health and Clinical Data 

Registry (CDR) Reporting 

As mentioned previously, we are 

proposing to adopt the consolidated 

Stage 3 version of the public health 

reporting objectives for all providers to 

demonstrate meaningful use for an EHR 

reporting period in 2015 through 2017. 

We note that this change does not 

fundamentally change a provider’s 

ability to demonstrate meeting the 

requirements of meaningful use with 

any actions they may have already taken 

or are in the progress of taking to meet 

the prior requirements of meaningful 

use defined in the Stage 1 and Stage 2 

rules for public health reporting. These 

requirements are currently defined at 

(75 FR 44325 through 44326) for EPs 

and (75 FR 44364 through 44368) for 

eligible hospitals and CAHs in the Stage 

1 final rule. In the Stage two final rule 

the requirements may be found at (77 

FR 54021 through 54026) for EPs and 

(77 FR 54029 through 54031) for eligible 

hospitals and CAHs. We further note 

that this change does not require the 

addition of any new technology or 

standard not already available in 

CEHRT to demonstrate meaningful use 

in 2014. 

This objective is designed based on 

the objective proposed in the Stage 3 

proposed rule at which builds on the 

requirements set forth in the Stage 2 

final rule (see for example 77 FR 54047 

through 54048 under the Health 

Outcomes Policy Priority ‘‘Improve 

population and public health’’). In the 

Stage 3 proposed rule, we proposed 

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 (80 FR 16739 

and 16740). 

Proposed Objective: The EP, 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. 

In the Stage 3 proposed rule, we 

highlighted our intention to remove the 

prior ongoing submission requirement 

and replace it with an ‘‘active 

engagement’’ requirement. We believe 

that ‘‘active engagement’’ as defined in 

the Stage 3 rule at (80 FR 16739 and 

16740) and reiterated in this section is 

more aligned with the process providers 

undertake to report to a clinical registry 

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 note that the change in definition 

is intended to better capture the 

activities a provider may conduct in 

order to engage with a PHA or CDR, and 

that any prior action taken to meet the 

non-consolidated public health 

reporting objectives of meaningful use 

Stages 1 and 2 would count toward 

meeting the active engagement 

requirement of this objective. 

Proposed Measures: We are proposing 

a total of 6 possible measures for this 

objective. For meaningful use in 2015 

through 2017, EPs would be required to 

choose from Measures 1 through 5, and 

would be required to successfully attest 

to any combination of two measures. 

For meaningful use in 2015 through 

2017, eligible hospitals and CAHs 

would be required to choose from 

Measures 1 through 6, and would be 

required to successfully attest to any 

combination of three measures. In 2015 

only for providers scheduled to be in 

Stage 1, EPs would be required to 

choose from Measures 1 through 5, but 

would be permitted to successfully 

attest to one measure; and eligible 

hospitals and CAHs would be required 

to choose from Measures 1 through 6, 

but would be permitted to successfully 

attest to any combination of two 

measures. The measures are as shown in 

Table 5. As noted, measures 4 and 5 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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The measures are as follows: 

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 (measure 4) 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 (measure 5) 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 two measures. Instead, in order 

to meet this objective an EP would need 

to meet two 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 two, the EP can 

meet the objective by meeting the one 

remaining measure available to them 

and claiming the applicable exclusions. 

If no measures remain available, the EP 

can meet the objective by claiming 

applicable exclusions for all measures. 

An EP who is scheduled to be in Stage 

1 in 2015 must report at least one 

measure unless they can exclude from 

all available measures. 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 three 

measures. Instead, in order to meet this 

objective an eligible hospital or CAH 

would need to meet three 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 three, the eligible hospital or CAH 

can meet the objective by meeting all of 

the remaining measures available to 

them and claiming the applicable 

exclusions. If no measures remain 

available, the eligible hospital or CAH 

can meet the objective by claiming 

applicable exclusions for all measures. 

An eligible hospital or CAH that is 

scheduled to be in Stage 1 in 2015 must 

report at least two measures unless they 

can either—(1) exclude from all but one 

available measure and report that one 

measure; or (2) can exclude from all 

available measures. 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 would 

aid the provider’s ability to care for their 

patients. 

To calculate the measures: 

• 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 

the EHR Incentive Programs 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 

system 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 (80 FR 16851), 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 for 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: 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: 

++ 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; 

++ 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 

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definition at the start of the EHR 

reporting period; or 

++ Operates in a jurisdiction where 

no immunization registry or 

immunization information system has 

declared readiness to receive 

immunization data from the EP, eligible 

hospital or CAHs 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 the EHR Incentive Programs 

because electronic syndromic 

surveillance is valuable for early 

detection of outbreaks, as well as 

monitoring disease and condition 

trends. 

We are 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 nonemergency 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 

by the following: 

Exclusion for EPs: Any EP meeting 

one or more of the following criteria 

may be excluded from the syndromic 

surveillance reporting measure if the 

EP— 

++ Does not treat or diagnose or 

directly treat any disease or condition 

associated with a syndromic 

surveillance system in his or her 

jurisdiction; 

++ 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 

++ 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: 

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— 

++ Does not have an emergency or 

urgent care department; 

++ 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 

++ 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. 

Electronic case reporting, however, 

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 paperbased and labor intensive case 

reporting. Electronic reporting would 

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 (80 

FR 16855). 

Exclusion: 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: 

++ 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; 

++ 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 

++ 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 responses to a 

Federal Register notice soliciting public 

comments on the proposed information 

collections to develop a centralized 

repository on public health readiness to 

support meaningful use (79 FR 7461); 

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 

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Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 20369 

4https://download.ama-assn.org/resources/doc/

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

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 would 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 2014 Edition final rule 

(see § 170.314(f)(6)) and CMS 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 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 agency 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. Under this 

measure, we note that cancer case 

reporting is not an option for eligible 

hospitals and CAHs, because hospitals 

have traditionally diagnosed and treated 

cancers (or both) and have the 

infrastructure needed to report cancer 

cases. 

Exclusions: 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— 

++ Does not diagnose or directly treat 

any disease or condition associated with 

a public health registry in their 

jurisdiction during the EHR reporting 

period; 

++ 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 

++ 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 4. 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 1 clinical data 

registry to meet the total number of 

required measures for this objective. 

ONC would 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. 

Exclusion: 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— 

++ Does not diagnose or directly treat 

any disease or condition associated with 

a clinical data registry in their 

jurisdiction during the EHR reporting 

period; 

++ 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 

++ 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 the EHR Incentive Programs 

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: 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— 

++ Does not perform or order 

laboratory tests that are reportable in 

their jurisdiction during the EHR 

reporting period; 

++ 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 

++ Operates in a jurisdiction where 

no public health agency has declared 

readiness to receive electronic 

reportable laboratory results from 

eligible hospitals or CAHs at the start of 

the EHR reporting period. 

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20370 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 

We seek public comment on this 

proposal. 

TABLE 6—MEANINGFUL USES OBJECTIVES AND MEASURES FOR 2015 THROUGH 2017 

Provider type 

Proposed objectives 

for 2015, 2016 and 

2017 

Proposed measures for providers in 2015, 

2016 and 2017 

Proposed alternate measures, exclusions 

and/or specifications for certain providers in 

2015 ONLY 

Eligible Professional .... CPOE ......................... • Measure 1: More than 60 percent of medication orders created by the EP or 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. 

• Measure 2: More than 30 percent of laboratory orders created by the EP or 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. 

• Measure 3: More than 30 percent of radiology orders created by the EP or 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. 

If for an EHR reporting period in 2015, the 

provider is scheduled to demonstrate Stage 

1: 

• Alternate Measure 1: More than 30 percent 

of all unique patients with at least one 

medication in their medication list seen by 

the EP or admitted to the eligible hospital’s 

or CAH’s inpatient or emergency department (POS 21 or 23) during the EHR reporting period have at least one medication 

order entered using CPOE; or more than 

30 percent of medication orders created by 

the EP during the EHR reporting period, or 

created by the authorized providers of the 

eligible hospital or CAH for patients admitted to their inpatient or emergency departments (POS 21 or 23) during the EHR reporting period, are recorded using computerized provider order entry. 

• Alternate Exclusion for Measure 2: Provider may claim an exclusion for measure 

2 (laboratory orders) of the Stage 2 CPOE 

objective for an EHR reporting period in 

2015. 

• Alternate Exclusion for Measure 3: Provider may claim an exclusion for measure 

3 (radiology orders) of the Stage 2 CPOE 

objective for an EHR reporting period in 

2015. 

Electronic Prescribing EP Measure: More than 50 percent of all permissible prescriptions, or all prescriptions, 

written by the EP are queried for a drug 

formulary and transmitted electronically 

using Certified EHR Technology. 

If for an EHR reporting period in 2015, the 

provider is scheduled to demonstrate Stage 

1: 

Alternate EP Measure: More than 40 percent 

of all permissible prescriptions written by 

the EP are transmitted electronically using 

Certified EHR Technology. 

Clinical Decision Support.• Measure 1: Implement five clinical decision 

support interventions related to four or 

more clinical quality measures at a relevant 

point in patient care for the entire EHR reporting period. Absent four clinical quality 

measures related to an EP, eligible hospital 

or CAH’s scope of practice or patient population, the clinical decision support interventions must be related to high-priority 

health conditions. It is suggested that one 

of the five clinical decision support interventions be related to improving healthcare 

efficiency. 

• 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. 

If for an EHR reporting period in 2015, the 

provider is scheduled to demonstrate Stage 

1: 

Alternate Objective and Measure 1: 

Objective: Implement one clinical decision 

support rule relevant to specialty or high 

clinical priority, or high priority hospital condition, along with the ability to track compliance with that rule. 

Measure: Implement one clinical decision 

support rule. 

Patient Electronic Access (VDT).• EP Measure 1: More than 50 percent of all 

unique patients seen by the EP during the 

EHR reporting period are provided timely 

(within 4 business days after the information is available to the EP) online access to 

their health information subject to the EP’s 

discretion to withhold certain information. 

Alternate Exclusion Measure 2: Provider may 

claim an exclusion for the second measure 

if for an EHR reporting period in 2015 they 

were scheduled to demonstrate Stage 1, 

which does not have an equivalent measure. 

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Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 20371 

TABLE 6—MEANINGFUL USES OBJECTIVES AND MEASURES FOR 2015 THROUGH 2017—Continued 

Provider type 

Proposed objectives 

for 2015, 2016 and 

2017 

Proposed measures for providers in 2015, 

2016 and 2017 

Proposed alternate measures, exclusions 

and/or specifications for certain providers in 

2015 ONLY 

• EP Measure 2: At least one patient seen 

by the EP during the EHR reporting period 

(or their authorized representatives) views, 

downloads, or transmits his or her health 

information to a third party. 

Protect Electronic 

Health Information.

Measure: Conduct or review a security risk 

analysis in accordance with the requirements in 45 CFR 164.308(a)(1), including 

addressing the security (to include 

encryption) of ePHI data stored in Certified 

EHR Technology in accordance with requirements in 45 CFR 164.312(a)(2)(iv) 

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

security updates as necessary and correct 

identified security deficiencies as part of 

the EP, eligible hospital, or CAHs risk management process. 

NONE. 

Patient Specific Education.EP Measure: Patient-specific education resources identified by Certified EHR Technology are provided to patients for more 

than 10 percent of all unique patients with 

office visits seen by the EP during the EHR 

reporting period. 

Alternate Exclusion: Provider may claim an 

exclusion for the measure of the Stage 2 

Patient Specific Education objective if for 

an EHR reporting period in 2015 they were 

scheduled to demonstrate Stage 1 but did 

not intend to select the Stage 1 Patient 

Specific Education menu objective. 

Medication Reconciliation.Measure: The EP, eligible hospital or CAH 

performs medication reconciliation for more 

than 50 percent of transitions of care in 

which the patient is transitioned into the 

care of the EP or admitted to the eligible 

hospital’s or CAH’s inpatient or emergency 

department (POS 21 or 23). 

Alternate Exclusion: Provider may claim an 

exclusion for the measure of the Stage 2 

Medication Reconciliation objective if for an 

EHR reporting period in 2015 they were 

scheduled to demonstrate Stage 1 but did 

not intend to select the Stage 1 Medication 

Reconciliation menu objective. 

Summary of Care ....... Measure: The EP, eligible hospital or CAH 

that transitions or refers their patient to another setting of care or provider of care (1) 

uses CEHRT to create a summary of care 

record; and (2) electronically transmits 

such summary to a receiving provider for 

more than 10 percent of transitions of care 

and referrals. 

Alternate Exclusion: Provider may claim an 

exclusion for Measure 2 of the Stage 2 

Summary of Care objective if for an EHR 

reporting period in 2015 they were scheduled to demonstrate Stage 1, which does 

not have an equivalent measure. 

Secure Messaging ..... Measure: During the EHR reporting period, 

the capability for patients to send and receive a secure electronic message with the 

provider was fully enabled. 

Alternate Exclusion: An EP may claim an exclusion for the measure if for an EHR reporting period in 2015 they were scheduled 

to demonstrate Stage 1, which does not 

have an equivalent measure. 

Public Health .............. • Measure Option 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). 

NONE. 

• Measure Option 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 Option 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. 

mstockstill on DSK4VPTVN1PROD with PROPOSALS3

20372 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 

TABLE 6—MEANINGFUL USES OBJECTIVES AND MEASURES FOR 2015 THROUGH 2017—Continued 

Provider type 

Proposed objectives 

for 2015, 2016 and 

2017 

Proposed measures for providers in 2015, 

2016 and 2017 

Proposed alternate measures, exclusions 

and/or specifications for certain providers in 

2015 ONLY 

• Measure Option 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 Option 5—Clinical Data Registry 

Reporting: The EP, eligible hospital, or 

CAH is in active engagement to submit 

data to a clinical data registry. 

Eligible Hospital/CAH .. CPOE ......................... • Measure 1: More than 60 percent of medication orders created by the EP or 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. 

• Measure 2: More than 30 percent of laboratory orders created by the EP or 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. 

• Measure 3: More than 30 percent of radiology orders created by the EP or 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. 

If for an EHR reporting period in 2015, the 

provider is scheduled to demonstrate Stage 

1: 

• Alternate Measure 1: More than 30 percent 

of all unique patients with at least one 

medication in their medication list seen by 

the EP or admitted to the eligible hospital’s 

or CAH’s inpatient or emergency department (POS 21 or 23) during the EHR reporting period have at least one medication 

order entered using CPOE; or more than 

30 percent of medication orders created by 

the EP or created by the authorized providers of the eligible hospital or CAH for 

patients admitted to their inpatient or emergency departments (POS 21 or 23) during 

the EHR reporting period are recorded 

using computerized provider order entry. 

• Alternate Exclusion for Measure 2: Provider may claim an exclusion for measure 

2 (laboratory orders) of the Stage 2 CPOE 

objective for an EHR reporting period in 

2015. 

• Alternate Exclusion for Measure 3: Provider may claim an exclusion for measure 

3 (radiology orders) of the Stage 2 CPOE 

objective for an EHR reporting period in 

2015. 

Clinical Decision Support.• Measure 1: Implement five clinical decision 

support interventions related to four or 

more clinical quality measures at a relevant 

point in patient care for the entire EHR reporting period. Absent four clinical quality 

measures related to an EP, eligible hospital 

or CAH’s scope of practice or patient population, the clinical decision support interventions must be related to high-priority 

health conditions. It is suggested that one 

of the five clinical decision support interventions be related to improving healthcare 

efficiency. 

• 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. 

If for an EHR reporting period in 2015, the 

provider is scheduled to demonstrate Stage 

1: 

Alternate Measure 1: Implement one clinical 

decision support rule. We propose that for 

an EHR reporting period in 2015, an EP, 

eligible hospital or CAH who is scheduled 

to participate in Stage 1 in 2015 must also 

satisfy the Stage 2 measure 2 previously 

stated because it is the same as an existing Stage 1 measure (77 FR 53998). There 

are no alternate exclusions for this objective. 

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Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 20373 

TABLE 6—MEANINGFUL USES OBJECTIVES AND MEASURES FOR 2015 THROUGH 2017—Continued 

Provider type 

Proposed objectives 

for 2015, 2016 and 

2017 

Proposed measures for providers in 2015, 

2016 and 2017 

Proposed alternate measures, exclusions 

and/or specifications for certain providers in 

2015 ONLY 

Patient Electronic Access (VDT).• Eligible Hospital/CAH Measure 1: More 

than 50 percent of all patients who are discharged from the inpatient or emergency 

department (POS 21 or 23) of an eligible 

hospital or CAH have their information 

available online within 36 hours of discharge. 

• Eligible Hospital/CAH Measure 2: At least 

1 patient who is discharged from the inpatient or emergency department (POS 21 or 

23) of an eligible hospital or CAH (or his or 

her authorized representative) views, 

downloads, or transmits to a third party his 

or her information during the EHR reporting 

period. 

Alternate Exclusion Measure 2: Provider may 

claim an exclusion for the second measure 

if for an EHR reporting period in 2015 they 

were scheduled to demonstrate Stage 1, 

which does not have an equivalent measure. 

Protect Electronic 

Health Information.

Measure: Conduct or review a security risk 

analysis in accordance with the requirements in 45 CFR 164.308(a)(1), including 

addressing the security (to include 

encryption) of ePHI data stored in Certified 

EHR Technology in accordance with requirements in 45 CFR 164.312(a)(2)(iv) 

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

security updates as necessary and correct 

identified security deficiencies as part of 

the EP, eligible hospital, or CAHs risk management process. 

NONE. 

Patient Specific Education.Eligible Hospital/CAH Measure: More than 10 

percent of all unique patients admitted to 

the eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) are 

provided patient specific education resources identified by Certified EHR Technology. 

Alternate Exclusion: Provider may claim an 

exclusion for the measure of the Stage 2 

Patient Specific Education objective if for 

an EHR reporting period in 2015 they were 

scheduled to demonstrate Stage 1 but did 

not intend to select the Stage 1 Patient 

Specific Education menu objective. 

Medication Reconciliation.Measure: The EP, eligible hospital or CAH 

performs medication reconciliation for more 

than 50 percent of transitions of care in 

which the patient is transitioned into the 

care of the EP or admitted to the eligible 

hospital’s or CAH’s inpatient or emergency 

department (POS 21 or 23). 

Alternate Exclusion: Provider may claim an 

exclusion for the measure of the Stage 2 

Medication Reconciliation objective if for an 

EHR reporting period in 2015 they were 

scheduled to demonstrate Stage 1 but did 

not intend to select the Stage 1 Medication 

Reconciliation menu objective. 

Summary of Care ....... Measure: The EP, eligible hospital or CAH 

that transitions or refers their patient to another setting of care or provider of care (1) 

uses CEHRT to create a summary of care 

record; and (2) electronically transmits 

such summary to a receiving provider for 

more than 10 percent of transitions of care 

and referrals. 

Alternate Exclusion: Provider may claim an 

exclusion for Measure 2 of the Stage 2 

Summary of Care objective if for an EHR 

reporting period in 2015 they were scheduled to demonstrate Stage 1, which does 

not have an equivalent measure. 

Electronic Prescribing Eligible Hospital/CAH Measure: More than 10 

percent of hospital discharge medication 

orders for permissible prescriptions (for 

new, changed and refilled prescriptions) 

are queried for a drug formulary and transmitted electronically using Certified EHR 

Technology. 

Alternate EH Exclusion: Measure Exclusion: 

Provider may claim an exclusion for the 

eRx objective and measure if for an EHR 

reporting period in 2015 they were either 

scheduled to demonstrate Stage 1 which 

does not have an equivalent measure, or if 

they are scheduled to demonstrate Stage 2 

but did not intend to select the Stage 2 

eRx menu objective for an EHR reporting 

period in 2015. 

Public Health .............. • Measure Option 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). 

NONE. 

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20374 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 

TABLE 6—MEANINGFUL USES OBJECTIVES AND MEASURES FOR 2015 THROUGH 2017—Continued 

Provider type 

Proposed objectives 

for 2015, 2016 and 

2017 

Proposed measures for providers in 2015, 

2016 and 2017 

Proposed alternate measures, exclusions 

and/or specifications for certain providers in 

2015 ONLY 

• Measure Option 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 Option 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 Option 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 Option 5—Clinical Data Registry 

Reporting: The EP, eligible hospital, or 

CAH is in active engagement to submit 

data to a clinical data registry. 

• Measure Option 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. 

3. Certified EHR Technology 

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 in 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 in 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). 

Rather than establishing a meaningful 

use specific CEHRT definition for the 

EHR Incentive Programs in the ONC 

2015 Edition proposed rule, we instead 

proposed to define the term ‘‘Certified 

EHR Technology’’ in the Stage 3 

proposed rule at § 495.4 (80 FR 16767 

and 16768). 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 

Medicare and Medicaid EHR Incentive 

Programs is clearly defined in CMS 

regulations. 

We are proposing no further changes 

to the definition of CEHRT in this 

proposed rule. We reiterate that 

providers must use EHR technology 

certified to the 2014 Edition for an EHR 

reporting period in 2015. As proposed 

in the Stage 3 proposed rule, providers 

must use EHR technology certified at 

least to the 2014 Edition in 2016 and 

2017. Providers may adopt EHR 

technology certified to the 2015 Edition 

prior to the beginning of Stage 3 in 2017 

or 2018, and that technology could be 

used to satisfy the definition of CEHRT 

under § 495.4 to demonstrate 

meaningful use (80 FR 16767 through 

16768). 

4. Medicaid EHR Incentive Program in 

2015 Through 2017 

The proposals included in this 

proposed rule would apply for 

providers participating in the Medicaid 

EHR Incentive Program in 2015 through 

2017. 

Consistent with both Stage 1 and 2, 

we propose to continue to offer states 

flexibility in the Medicaid EHR 

Incentive Program for meaningful use in 

2015 through 2017. This flexibility 

would apply to the public health 

reporting objective and measures where 

we propose to continue to allow states 

to specify the means of transmission of 

the data or otherwise change the public 

health reporting objective and measures 

as long as it does not require EHR 

functionality above and beyond that 

which is included in 45 CFR part 170 

as stated in the Stage 2 final rule (77 FR 

53979). 

Finally, we propose to provide an 

alternate attestation option for Medicaid 

providers who are seeking to 

demonstrate meaningful use to avoid 

the Medicare payment adjustment and 

who are prohibited from switching 

between the Medicare and Medicaid 

EHR incentive programs. For these 

providers, we propose that they may use 

the Medicare Registration and 

Attestation system to attest to 

meaningful use without switching 

programs solely for the purposes of 

avoiding the Medicare payment 

adjustment. We are proposing this 

alternate attestation option in response 

to concerns about providers who 

participate in the Medicaid EHR 

Incentive Program; but, due to their 

patient volume or another similar factor, 

they are unable to attest to meaningful 

use through their state Medicaid 

program for a given year. If such a 

provider uses the alternate attestation 

option to demonstrate meaningful use 

for an EHR reporting period, they may 

avoid the Medicare payment adjustment 

associated with that EHR reporting 

period without switching out of the 

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Medicaid EHR Incentive Program. This 

option is discussed in further detail in 

section II.D. of this proposed rule. 

We invite public comment on these 

proposals. 

C. Clinical Quality Measurement 

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 the Stage 2 final 

rule, we outlined the CQMs available for 

use in the EHR Incentive Programs 

beginning in 2014 for EPs, eligible 

hospitals, and CAHs at (77 FR 54057 

through 54068 for EPs and 77 FR 54081 

through 54087 for eligible hospitals/

CAHs) as well as the form and method 

for submission at (77 FR 54076 through 

54080 for EPs and 77 FR 54087 through 

54089 for eligible hospitals/CAHs). 

Following the publication of the Stage 2 

final rule, we also established 

requirements for reporting on CQMs 

under the EHR Incentive Program in the 

PFS and IPPS rules (see for example 79 

FR 50319 through 50321 and 79 FR 

67779). In sections II.B.1.a. and b. of the 

preamble of the Stage 3 proposed rule, 

we outlined the requirements for CQM 

reporting for all providers for the EHR 

Incentive Programs in 2017 and 

subsequent years (80 FR 16768 and 

16769) as well as the intent to continue 

program alignment with other CMS 

quality reporting programs in the IPPS 

and PFS rules. 

In this proposed rule for meaningful 

use in 2015 through 2017, we are 

proposing to maintain the existing 

requirements established in earlier 

rulemaking for the reporting of CQMs. 

The options for CQM submission for 

providers in the Medicare EHR 

Incentive Program are as follows: 

• EP Options for Medicare EHR 

Incentive Program Participation (single 

program participation) 

++ Option 1: Attest to CQMs through 

the EHR Registration & Attestation 

System. 

++ Option 2: Electronically report 

CQMs through Physician Quality 

Reporting System (PQRS) Portal. 

• EP Options for Electronic Reporting 

for Multiple Programs (for example: 

EHR Incentive Program plus PQRS 

participation) 

++ Option 1: Report individual 

eligible professionals’ CQMs through 

PQRS Portal. 

++ Option 2: Report group’s CQMs 

through PQRS Portal. 

We note that under option 2, this may 

include an EP reporting using the group 

reporting option, either electronically 

using QRDA, or via the GPRO Web 

Interface through Pioneer ACO 

participation. 

• Eligible hospital and CAH Options 

for Medicare EHR Incentive Program 

Participation (single program 

participation) 

++ Option 1: Attest to CQMs through 

the EHR Registration & Attestation 

System. 

++ Option 2: Electronically report 

CQMs through QualityNet Portal. 

• Eligible hospital and CAH Options 

for Electronic Reporting for Multiple 

Programs (for example: EHR Incentive 

Program plus IQR participation) 

++ Electronically report through 

QualityNet Portal. 

For the Medicaid EHR Incentive 

Program, states would continue to be 

responsible for determining whether 

and how electronic reporting of CQMs 

would occur, or if they wish to allow 

reporting through attestation. Any 

changes that states make to their CQM 

reporting methods must be submitted 

through the State Medicaid Health IT 

Plan (SMHP) process for our review and 

approval prior to being implemented. 

We are also proposing to maintain the 

existing CQM reporting requirements of 

nine CQMs covering at least three NQS 

domains for EPs and 16 CQMs covering 

at least three NQS domains for eligible 

hospitals and CAHs (77 FR 54058 for 

EPs and 77 FR 54056 for eligible 

hospitals and CAHs). 

As discussed in section II.B.2(a) of 

this proposed rule, beginning in 2015, 

we are proposing to change the 

definition of ‘‘EHR reporting period’’ in 

§ 495.4 for eligible hospitals and CAHs 

such that the EHR reporting period 

would begin and end in relation to a 

calendar year. In connection with this 

proposal, we also propose that in 2015 

and for all methods of reporting, eligible 

hospitals and CAHs would be required 

to complete a reporting period for 

clinical quality measures aligned with 

the calendar year in order to 

demonstrate meaningful use. In order to 

accommodate eligible hospitals and 

CAHs that may have planned their 

clinical quality measure reporting in 

2015 based on the federal fiscal year, we 

propose for 2015 only that eligible 

hospitals and CAHs that are submitting 

CQMs via attestation, may begin a 

reporting period as early as October 1 of 

2014 and end by December 31 of 2015. 

Eligible hospitals and CAHs submitting 

CQMs via electronic reporting must 

meet the requirements established in the 

FY 2015 final rule (79 FR 50319 through 

50321). 

As discussed in section II.B.1.b.(3). of 

this proposed rule, for 2015 only, we are 

proposing to change the EHR reporting 

period for all EPs, eligible hospitals, and 

CAHs to any continuous 90-day period 

within the calendar year. In connection 

with this proposal, we also propose a 

90-day reporting period for clinical 

quality measures for all EPs, eligible 

hospitals, and CAHs that report clinical 

quality measures by attestation. We are 

proposing eligible professionals may 

select any continuous 90-day period 

from January 1, 2015 through December 

31, 2015, while eligible hospitals and 

CAHs may select any continuous 90-day 

period from October 1, 2014 through 

December 31, 2015, to report CQMs via 

attestation using the EHR Incentive 

Program registration and attestation 

system. In accordance with our existing 

policy, it is acceptable for a provider to 

use a continuous 90-day reporting 

period for CQMs even if it is different 

from their continuous 90-day EHR 

reporting period for the meaningful use 

objectives and measures if that provider 

is reporting via attestation. We also 

propose that a provider may choose to 

attest to a CQM reporting period of 

greater than 90-days up to and including 

1 full calendar year of data. 

We further propose to continue our 

existing policy that providers in any 

year of participation for the EHR 

Incentive Programs for 2015 through 

2017 may instead electronically report 

CQM data using the options previously 

outlined for electronic reporting either 

for single program participation in the 

Medicare EHR Incentive Programs, or 

for participation in multiple programs if 

the requirements of the aligned quality 

program are met. 

We note that EPs seeking to 

participate in multiple programs with a 

single electronic submission would be 

required to submit a full calendar year 

of CQM data using the 2014 electronic 

specifications for the CQMs (which are 

also known as eCQMs) for a reporting 

period in 2015. These specifications 

include the annual updates released in 

June of 2014 and are available at the 

CMS eCQMs Library (http://cms.gov/

Regulations-and-Guidance/Legislation/

EHRIncentivePrograms/eCQM_

Library.html) 

Eligible hospitals and CAHs seeking 

to participate in multiple programs with 

a single electronic submission for a 

reporting period in 2015 would be 

required to submit 1 calendar quarter of 

data for 2015 from either Q1 (January 1, 

2015–March 31, 2015), Q2 (April 1, 

2015 June 30, 2015), or Q3 (July 1, 

2015–September 30, 2015) and would 

require of the use of the April 2014 

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CMS eCQM Library (http://cms.gov/

Regulations-and-Guidance/Legislation/

EHRIncentivePrograms/eCQM_

Library.html). For further information, 

we direct readers to the FY 2015 IPPS 

final rule at 79 FR 50319 through 50321. 

We note that an EHR certified for 

CQMs under the 2014 Edition 

certification criteria does not need to be 

recertified each time it is updated to a 

more recent version of the eCQMs. (For 

further information on CQM reporting, 

we direct readers to the EHR Incentive 

Program Web site where guides and tip 

sheets are available for each reporting 

option (www.CMS.gov/

ehrincentiveprograms)). 

We invite public comment on this 

proposal. 

D. Demonstration of Meaningful Use for 

2015 Through 2017 

1. 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. 

2. Methods for Demonstration of the 

Criteria for Meaningful Use in 2015 

Through 2017 

As mentioned previously in section 

II.B.2. of this proposed rule, we are 

redesignating the numbering of certain 

sections of the regulation text under 42 

CFR part 495. In prior rules, we defined 

the criteria for the demonstration of 

meaningful use at 42 CFR 495.8, which 

would be redesignated as § 495.40. In 

this proposed rule, we define the 

criteria for the demonstration of 

meaningful use at § 495.40 including 

references to the objectives and 

measures of meaningful use as well as 

the requirement to report CQMs. In 

order to demonstrate meaningful use in 

2015 through 2017, we are proposing 

that the requirements at § 495.40 

include a reference to the objectives and 

measures of meaningful use for 2015 

through 2017 outlined at § 495.22 which 

the provider must satisfy. 

We are proposing to continue the use 

of attestation as the method for 

demonstrating that an EP, eligible 

hospital, or CAH has met the objectives 

and measures of meaningful use. Instead 

of individual Medicare EP attestation 

through the CMS Registration and 

Attestation System, we are also 

proposing to continue the existing 

optional batch file process for 

attestation. Further, we are proposing 

changes to the deadlines for EPs, 

eligible hospitals, and CAHs to 

demonstrate meaningful use in 2015 

and 2016; as well as specific changes to 

the deadlines for providers to 

demonstrate meaningful use for the first 

time in order to avoid a payment 

adjustment in 2015 and 2016. 

a. Attestation Deadlines for Meaningful 

Use in 2015 and 2016 

In order to accommodate the 

proposed changes to the EHR reporting 

period, we are proposing changes to the 

attestation deadlines for eligible 

hospitals and CAHs for 2015 and 2016. 

Currently, in order to demonstrate 

meaningful use, eligible hospitals and 

CAHs are required to complete an EHR 

reporting period within a federal fiscal 

year. These providers must then attest to 

that EHR reporting period by the end of 

the open attestation period 2 months 

after the close of the federal fiscal year. 

For 2015, this means that eligible 

hospitals and CAHs must complete an 

EHR reporting period between October 

1, 2014 and September 30, 2015 and 

must attest by November 30, 2015. 

However, we are proposing in section 

II.B.3.a. of this proposed rule that 

eligible hospitals and CAHs would 

instead be required to complete an EHR 

reporting period for 2015 between 

October 1, 2014 and the end of the 

calendar year on December 31, 2015, 

and to complete an EHR reporting 

period for 2016 between January 1, 2016 

and December 31, 2016. 

Therefore, we are proposing a change 

to the attestation deadlines as follows: 

• For an EHR reporting period in 

2015, an eligible hospital or CAH must 

attest by February 29, 2016. 

• For an EHR reporting period in 

2016, an eligible hospital or CAH must 

attest by February 28, 2017. 

In addition, despite the proposed 

change to a 90-day EHR reporting period 

in 2015 discussed previously in this 

proposed rule, providers would not be 

able to attest to meaningful use for an 

EHR reporting period in 2015 prior to 

January 1, 2016. This would allow us 

adequate time to make the system 

changes necessary to accept attestations 

reflecting the proposals in this proposed 

rule. This would mean that even if 

providers successfully complete a 

continuous 90-day EHR reporting period 

in the first quarter of FY or CY 2015, 

they would attest after the close of the 

fourth quarter of CY 2015. This change 

would not delay incentive payments for 

Medicare EPs, because 2015 cannot be 

an EP’s first payment year under section 

1848(o)(1)(B)(v) of the Act. Thus, all EPs 

who qualify for an incentive payment 

for 2015 would be returning participants 

in the program and would have had the 

full CY 2015 (as their EHR reporting 

period under our current policy). We 

understand that this may delay 

incentive payments for eligible hospitals 

and CAHs. However, most eligible 

hospitals and CAHs in the program are 

beyond their first year of demonstrating 

meaningful use; thus, would not have 

been attesting until after September 30, 

2015 under our current policy. 

Therefore, for most eligible hospitals 

and CAHs, this change would shift the 

incentive payment by 1 quarter within 

the same federal fiscal year. Thus, we 

believe the potential negative impact of 

this change would be minimal and 

outweighed by the opportunity to 

capitalize on efficiencies created by 

aligning the EHR reporting periods 

across EPs, eligible hospitals, and CAHs. 

We invite public comment on this 

proposal. 

b. New Participant Attestation 

Deadlines for Meaningful Use in 2015 

and 2016 To Avoid a Payment 

Adjustment 

In § 495.4 the definition of an EHR 

reporting period for a payment 

adjustment year establishes special 

deadlines for attestation for EPs and 

eligible hospitals that are demonstrating 

meaningful use for the first time in the 

year immediately preceding a payment 

adjustment year. Generally stated, a 

provider must complete an EHR 

reporting period in the first 3 quarters 

of the preceding year, and the deadlines 

for attestation are October 1 for EPs and 

July 1 for eligible hospitals of the 

preceding year. For CAHs, the EHR 

reporting period is within the federal 

fiscal year that is the payment 

adjustment year and the deadline for 

attestation for CAHs is the same for 

purposes of the incentive payment and 

the payment adjustment (November 30, 

2015). After the October 1 or July 1 

deadlines, EPs and eligible hospitals 

may still attest for an EHR reporting 

period in the fourth quarter of the CY 

or FY, respectively. However, if they 

attest after the respective deadlines, 

then they would not avoid the Medicare 

payment adjustment in the subsequent 

payment adjustment year. 

In the Stage 2 proposed rule (77 FR 

13769 for EPs and 77 FR 13773 through 

13774 for eligible hospitals/CAHs), we 

explained the rationale for these special 

deadlines for attestation. We explained 

that these EHR reporting periods 

provide adequate time both for the 

systems changes that will be required 

for us to apply any applicable payment 

adjustments and for providers to be 

informed in advance of the payment 

year whether a payment adjustment 

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would apply. Those deadlines also 

provide appropriate flexibility by 

allowing more recent adopters of EHR 

technology a reasonable opportunity to 

establish their meaningful use of the 

technology and to avoid application of 

the payment adjustments. However, we 

are proposing a later deadline for 

attestation only for 2015 to allow 

enough time for all providers to 

complete a 90-day EHR reporting period 

after the anticipated effective date of the 

final rule. As a result of this later 

deadline, in 2016, providers that are 

new participants in the EHR Incentive 

Program may be subject to a payment 

adjustment on claims submitted prior to 

attestation to meaningful use for an EHR 

reporting period in 2015. After 

successful attestation, the payment 

adjustment would be removed and any 

adjustments previously applied to 

claims in 2016 would be reprocessed 

and reconciled for the provider. 

However, as our policies seek to 

minimize the claims reprocessing 

burden, we note these are exceptional 

circumstances caused by the need for a 

later attestation deadline to 

accommodate a 90-day EHR reporting 

period in 2015 after the effective date of 

the final rule, and this is not an 

acceptable long-term solution. For the 

reasons previously stated in the Stage 2 

proposed rule, the special deadlines for 

first-time meaningful EHR users 

(October 1 for EPs and July 1 for eligible 

hospitals) are necessary in 2016 and 

subsequent years where no extenuating 

circumstances exist. For these reasons, 

we propose changes to the attestation 

deadlines for purposes of the payment 

adjustment years in section II.E.2.(a). 

through (c). of this proposed rule. 

We invite public comment on these 

proposals. 

3. Alternate Method of Demonstration 

for Certain Medicaid Providers 

Beginning in 2015 

At 42 CFR 495.10, redesignated as 

§ 495.60, we defined the requirements 

for EPs switching between the Medicare 

and Medicaid EHR Incentive Programs. 

An EP who qualifies as both a Medicaid 

EP and a Medicare EP must notify us as 

to whether he or she elects to participate 

in the Medicare or the Medicaid EHR 

Incentive Program, and after receiving at 

least one incentive payment, may 

switch between the two EHR incentive 

programs only one time, and only for a 

payment year before 2015. For further 

discussion of this policy we direct 

readers to (75 FR 44324 through 44325). 

We are not proposing any changes to the 

switching requirements under § 495.60. 

However, we note that an EP who 

qualifies as both a Medicaid EP and a 

Medicare EP would be subject to the 

Medicare payment adjustment if the EP 

fails to demonstrate meaningful use for 

the applicable EHR reporting period for 

a payment adjustment year. We 

recognize it is possible that an EP who 

receives an incentive payment under the 

Medicaid EHR Incentive Program for a 

given year may fail in a subsequent year 

to meet the eligibility criteria for the 

Medicaid EHR Incentive Program. For 

example, the EP would be unable to 

qualify for a Medicaid EHR incentive 

payment for 2015, if he or she receives 

a Medicaid EHR incentive payment for 

meaningful use for the 2013 payment 

year, but does not meet the 30 percent 

Medicaid patient volume requirement 

for purposes of the 2015 payment year. 

Under § 495.60(e), in this example in 

order to avoid the Medicare payment 

adjustment, the EP would be unable to 

switch to the Medicare EHR Incentive 

Program for the 2015 payment year; 

thus, the EP would not have a way to 

demonstrate meaningful use for an 

applicable EHR reporting period for the 

payment adjustment year. Therefore, for 

purposes of avoiding the Medicare 

payment adjustment, we are proposing 

to establish an additional attestation 

option to allow EPs who have received 

at least one incentive payment under 

the Medicaid EHR Incentive Program 

(for either AIU or meaningful use) to 

demonstrate meaningful use by 

attestation using the EHR Incentive 

Program Registration and Attestation 

system. We note that this attestation 

would not constitute a switch from the 

Medicaid EHR Incentive Program to the 

Medicare EHR Incentive Program, and 

EPs who attest under this option would 

not earn an incentive payment in either 

program for the year. We are proposing 

this attestation option for the purposes 

of demonstrating meaningful use to 

avoid the Medicare payment adjustment 

only. In the prior example, the EP 

whose Medicaid patient volume was 

less than the required threshold would 

be able to attest to meaningful use for 

an EHR reporting period in 2015 to 

avoid the 2017 payment adjustment. 

This EP would continue to be 

designated a Medicaid EHR Incentive 

Program participant. In 2016 in order to 

earn an incentive payment and avoid a 

Medicare payment adjustment, if the EP 

meets the Medicaid patient volume 

threshold with regard to the 2016 

payment year, then the EP would be 

required to demonstrate meaningful use 

in the Medicaid program for an EHR 

reporting period. 

As stated above, we are proposing that 

EPs who have previously received an 

incentive payment under Medicaid for 

adopting, implementing, or upgrading to 

certified EHR technology may also use 

this alternate attestation option even if 

it is their first year of demonstrating 

meaningful use. However, these EPs 

would be required to demonstrate 

meaningful use for the EHR reporting 

periods established for the Medicare 

EHR Incentive Program for EPs who 

have never successfully demonstrated 

meaningful use in a prior year. In the 

Stage 3 proposed rule (80 FR 16739), we 

propose that beginning in 2017, EPs 

who demonstrate meaningful use for the 

first time under the Medicare EHR 

Incentive Program must use an EHR 

reporting period of one full calendar 

year. Accordingly, under our proposal 

in this rule, Medicaid providers using 

this alternate attestation option in 2017 

or subsequent years would also be 

required to use an EHR reporting period 

of 1 full calendar year even if they are 

demonstrating meaningful use for the 

first time. 

We invite public comment on this 

proposal. 

4. Data Collection for Online Posting, 

Program Coordination, and Accurate 

Payments 

We propose no changes to the data 

collection requirements or to the 

registration requirements under 

§ 495.10, redesignated as § 495.60. As 

noted in section II.C.2 of the Stage 3 

proposed rule, we note that we intend 

to continue to post meaningful use 

participation data both at an individual 

and aggregate level for the purposes of 

data transparency, program integrity, 

and for use with aligned CMS quality 

reporting programs. 

5. Hospital-Based Eligible Professionals 

Section 1848(o)(1)(C)(i) of the Act, as 

added by section 4101(a) of the HITECH 

Act, states that hospital-based EPs are 

not eligible for Medicare incentive 

payments. Similarly, the majority of 

hospital-based EPs will not be eligible 

for Medicaid incentive payments under 

section 1903(t)(2)(A) of the Act (the only 

exception to this rule is for those 

practicing predominantly in an FQHC or 

RHC). Sections 4101(a) and 4201(a) of 

the HITECH Act originally defined the 

term ‘‘hospital-based eligible 

professional’’ to mean an EP, such as a 

pathologist, anesthesiologist, or 

emergency physician, who furnishes 

substantially all of his or her Medicare 

covered professional services during the 

relevant EHR reporting period in a 

hospital setting (whether inpatient or 

outpatient) through the use of the 

facilities and equipment of the hospital, 

including the hospital’s qualified EHRs. 

Following publication of the Stage 1 

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proposed rule (75 FR 1844 through 

2011), Congress modified the definition 

of hospital-based EPs. Specifically, on 

April 15, 2010, President Obama signed 

into law the Continuing Extension Act 

of 2010 (Pub. L. 111–157). Section 5 of 

the Continuing Extension Act of 2010 

(Pub. L. 111–157) made the following 

changes to the Act as it applies to both 

the Medicare and Medicare EHR 

incentives for EPs: 

• Qualifications for Clinic-based 

Physicians 

++ Medicare—Section 

1848(o)(1)(C)(ii) of the Act (42 U.S.C. 

1395w–4(o)(1)(C)(ii)) is amended by 

striking ‘‘setting (whether inpatient or 

outpatient)’’ and inserting ‘‘inpatient or 

emergency room setting’’. 

++ Medicaid—Section 1903(t)(3)(D) of 

the Act (42 U.S.C. 1396b(t)(3)(D)) is 

amended by striking ‘‘setting (whether 

inpatient or outpatient)’’ and inserting 

‘‘inpatient or emergency room setting’’. 

These amendments were effective as 

if included in the enactment of the 

HITECH Act. The previous sections 

indicate that the determination of 

whether an EP is a hospital-based EP 

shall be made on the basis of the site of 

service, as defined by the Secretary, and 

without regard to any employment or 

billing arrangement between the EP and 

any other provider. For example, the 

hospital-based determination for an EP 

would not be affected by whether the EP 

is an employee of the hospital, under a 

contractual relationship with the 

hospital, or with respect to whether he 

or she has made a reassignment to the 

hospital for Part B billing purposes. In 

addition, section 1848(a)(7)(D) of the 

Act, as added by section 4101(b) of the 

HITECH Act, exempts hospital-based 

EPs from the downward payment 

adjustment applied under section 

1848(a)(7)(A)(i) of the Act to covered 

professional services provided during a 

payment year by EPs who are not 

meaningful EHR users for the relevant 

payment year beginning in 2015. 

Based on section 4101(a) of the 

HITECH Act (and prior to the 

amendments in the Continuing 

Extension Act of 2010), we proposed in 

the Stage 1 proposed rule (75 FR 1904 

through1907) that an EP would be 

considered a hospital-based EP; 

therefore, ineligible to receive a 

Medicare or Medicaid EHR incentive 

payment if more than 90 percent of their 

services are provided in the following 

place of service (POS) codes for HIPAA 

standard transactions— 

• 21—Inpatient Hospital; 

• 22—Outpatient Hospital; 

• 23—Emergency Room. 

In the Stage 1 final rule (75 FR 44439 

through 44442), we incorporated the 

changes to the hospital-based definition, 

that were included in the Continuing 

Extension Act of 2010, into our 

definition of ‘‘hospital-based EP’’ under 

§ 495.4. We defined an EP as hospitalbased if he or she furnishes 90 percent 

or more of his or her covered 

professional services in sites of service 

identified as an inpatient hospital (POS 

21) or emergency room (POS 23) setting 

in the year preceding the payment year. 

We did not include POS 22 for 

outpatient hospital settings in our final 

definition. 

As noted previously, section 

1848(a)(7)(D) of the Act exempts 

hospital-based EPs who are not 

meaningful EHR users from the 

downward payment adjustments under 

Medicare. In the Stage 2 final rule (77 

FR 54102), for purposes of the Medicare 

payment adjustments, we amended the 

definition of hospital-based EP under 

§ 495.4 to define a hospital-based EP as 

an EP who furnishes 90 percent or more 

of his or her covered professional 

services in sites of service identified as 

an inpatient hospital (POS 21) or 

emergency room (POS 23) setting in 

either of the 2 years before the year 

preceding a payment adjustment year. 

However, recently several hospital 

associations, individual providers, and 

other stakeholders have raised concerns 

with our current definition of a hospitalbased EP. Specifically, these 

stakeholders asserted that the limitation 

of hospital-based to POS codes 21 and 

23, covering inpatient and emergency 

room settings only, does not adequately 

capture all settings where services might 

be furnished by a hospital-based EP. 

They stated that POS 22, which covers 

an outpatient hospital place of service, 

is also billed by hospital-based EPs, 

especially in relation to certain CPT 

codes. These stakeholders expressed the 

belief that our current definition of 

hospital-based EP in the regulations is 

too narrow and will unfairly subject 

many EPs who are not hospital-based 

under our definition, but who 

stakeholders would consider to be 

hospital-based, to the downward 

payment adjustment under Medicare in 

2015. Accordingly, these stakeholders 

recommended that we consider adding 

additional place of service codes or 

settings to the regulatory definition of 

hospital-based EP. 

We appreciate this feedback from 

stakeholders and are requesting public 

comment on our current definition of a 

hospital-based EP under § 495.4 for the 

EHR Incentive Programs. 

We are seeking public comment on 

whether additional place of service 

codes or settings should be included in 

our definition of a hospital-based EP. As 

stated previously, stakeholders 

specifically identified POS 22 for 

outpatient hospital settings as an area of 

concern; therefore, we are especially 

interested in comments on POS 22 for 

outpatient hospital settings. In addition, 

we seek comments on whether and how 

the inclusion of additional POS codes or 

settings in our definition of hospitalbased EP might affect the eligibility of 

EPs for the EHR incentive payments 

under Medicare or Medicaid. 

We welcome public comment. 

E. 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 

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

for payment adjustments, effective for 

CY 2015 and subsequent years, for EPs 

as defined in § 495.100, who are not 

meaningful EHR users during the 

relevant EHR reporting period for the 

year. Section 1848(a)(7) of the Act 

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 

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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 Stages 1 and 2 final rules (75 FR 

44442 through 44448, 77 FR 54093 

through 54102) for more information. 

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 would be ‘‘33 1/3 percent for FY 

2015, 66 2/3 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 (33 1/3 of 75 percent) in 

FY 2015; 

• 50 percent (66 2/3 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 FY 

involved and the Secretary shall not 

take into account such reduction in 

computing the applicable percentage 

increase for a subsequent FY.’’ 

Section 412.64(d) of our 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. 

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

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

HITECH Act, provides that the Secretary 

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

hospital from the application of the 

applicable percentage increase 

adjustment for a fiscal year if the 

Secretary determines that requiring such 

hospital to be a meaningful EHR user 

would result in a significant hardship, 

such as in the case of a hospital in a 

rural area without sufficient internet 

access. This section of the Act 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. 

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 would 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 cases 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. 

In the Stage 1 final rule (75 FR 44564 

and 44574), we finalized the regulations 

regarding the CAH adjustment at 

§ 495.106(e) and § 413.70(a)(6). 

2. EHR Reporting Period for a Payment 

Adjustment Year 

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

provides the Secretary with broad 

authority to choose the EHR reporting 

period that would apply for purposes of 

determining the payment adjustments 

for EPs 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 our 

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. Generally 

stated, 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 our regulations and the 

discussion in the Stage 2 final rule (77 

FR 54095 through 54096). We 

established that these policies apply for 

the CY 2015 payment adjustment year 

and subsequent payment adjustment 

years. 

Similarly, 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 

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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 our 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. 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. Generally 

stated, 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 through 

54105). 

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 

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 FY as described in 

§ 413.70(a)(6)(i). We further finalized 

that CAHs submit their attestations on 

meaningful use by November 30th of the 

following FY. For example, if a CAH is 

attesting that it was a meaningful EHR 

user for FY 2015, the attestation must be 

submitted no later than November 30, 

2015. Such an attestation or lack 

thereof, would then affect interim 

payments to the CAH made after 

December 1st of the applicable FY. If the 

cost reporting period ends prior to 

December 1st of the applicable FY, then 

any applicable payment adjustment 

would be made through the cost report 

settlement process 

In the Stage 3 proposed rule (80 FR 

16774 through 16779), we proposed to 

eliminate the exception discussed 

previously for a 90-day EHR reporting 

period for new meaningful EHR users in 

the Medicare EHR Incentive Program 

beginning with the EHR reporting 

period in 2017, with a limited exception 

for new meaningful EHR users under 

the Medicaid EHR Incentive Program. 

We also proposed for eligible hospitals 

and CAHs to shift the EHR reporting 

period for a payment adjustment year 

from a fiscal year basis to a calendar 

year basis. We proposed that for EPs and 

eligible hospitals demonstrating 

meaningful use under the Medicare EHR 

Incentive Program, including those 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 further 

information on these proposals, we 

direct readers to the Stage 3 proposed 

rule (80 FR 16739 and 16740). 

In the Stage 3 proposed rule, we also 

proposed a change to the EHR reporting 

period that would apply for the 

payment adjustments for CAHs, 

beginning with the FY 2017 payment 

adjustment year. Similar to what we 

proposed for eligible hospitals, we 

proposed 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 

proposed 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 2017 

calendar year. For further information 

on these proposals, we direct readers to 

the Stage 3 proposed rule (80 FR 16777 

through 16779). 

In the Stage 3 proposed rule, we 

proposed amendments to the definition 

of ‘‘EHR reporting period for a payment 

adjustment year’’ under § 495.4 to 

reflect these proposals for EPs, eligible 

hospitals, and CAHs. 

In this proposed rule, we are 

proposing several changes to the 

definition of the EHR reporting period 

for a payment adjustment year for EPs, 

eligible hospitals, and CAHs at § 495.4, 

in connection with other proposals 

made in this rule. Specifically, as stated 

in section I.A.2.b. of this proposed rule, 

we propose to change the EHR reporting 

period in 2015 to 90 days for all 

providers. This 90-day EHR reporting 

period in 2015 would allow adequate 

time to accommodate the changes to the 

objectives and measures of meaningful 

use proposed in this rule. We are also 

proposing to move all providers to an 

EHR reporting period based on the 

calendar year beginning in 2015 to 

support program alignment and simplify 

reporting requirements among provider 

types (section I.A.2.a. of this proposed 

rule). 

a. Changes to the EHR Reporting Period 

for a Payment Adjustment Year for EPs 

We propose a change to our current 

policy for 2015 only. We propose that 

for all EPs, including those who have 

demonstrated meaningful use in a prior 

year and those who have not, the EHR 

reporting period for a payment 

adjustment year would be any 

continuous 90-day period in CY 2015 

and would apply for purposes of the 

payment adjustments in CY 2016 for 

EPs demonstrating meaningful use for 

the first time in 2015 and for purposes 

of the payment adjustments in CY 2017 

for both returning and new participant 

EPs who demonstrate meaningful use in 

2015. We propose the deadline for 

attestation would be February 29, 2016. 

We would maintain our current 

policy for 2016. Under that policy, if an 

EP is demonstrating meaningful use for 

the first time in 2016, the EHR reporting 

period for a payment adjustment year is 

any continuous 90-day period in CY 

2016 and applies for purposes of the 

payment adjustments in CYs 2017 and 

2018. To avoid the payment adjustment 

in CY 2017, the 90-day period must 

occur within the first three quarters of 

CY 2016 and the EP must attest by 

October 1, 2016. If an EP has previously 

demonstrated meaningful use, the EHR 

reporting period for a payment 

adjustment year is the full CY 2016 and 

applies for purposes of the payment 

adjustment in CY 2018. 

We invite comment on this proposal. 

b. Changes to the EHR Reporting Period 

for a Payment Adjustment Year for 

Eligible Hospitals 

We propose a change to our current 

policy for 2015. We propose that for all 

eligible hospitals, including those that 

have demonstrated meaningful use in a 

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prior year and those that have not, the 

EHR reporting period for a payment 

adjustment year would be any 

continuous 90-day period beginning 

October 1, 2014 and ending December 

31, 2015. This EHR reporting period 

would apply for purposes of the 

payment adjustments in FY 2016 for 

eligible hospitals demonstrating 

meaningful use for the first time in 2015 

and for purposes of the payment 

adjustments in FY 2017 for both 

returning and new participant eligible 

hospitals that demonstrate meaningful 

use in 2015. We propose the deadline 

for attestation would be February 29, 

2016. 

We also propose to change our current 

policy for 2016. We propose that if an 

eligible hospital is demonstrating 

meaningful use for the first time in 

2016, the EHR reporting period for a 

payment adjustment year would be any 

continuous 90-day period in CY 2016 

and apply for purposes of the payment 

adjustments in FYs 2017 and 2018. To 

avoid the payment adjustment in FY 

2017, the 90-day period must occur 

within the first three quarters of CY 

2016, and the eligible hospital must 

attest by October 1, 2016. If an eligible 

hospital has previously demonstrated 

meaningful use, the EHR reporting 

period for a payment adjustment year 

would be the full CY 2016, the 

attestation deadline would be February 

28, 2017, and this EHR reporting period 

would apply for purposes of the 

payment adjustment in FY 2018. 

c. Changes to the EHR Reporting Period 

for a Payment Adjustment Year for 

CAHs 

For CAHs, we are proposing to shift 

the EHR reporting period for a payment 

adjustment year from the federal fiscal 

year that is the payment adjustment year 

to the calendar year that begins on the 

first day of the second quarter of the 

federal fiscal year that is the payment 

adjustment year. In the Stage 3 proposed 

rule, we outline how CAHs are different 

from EPs and eligible hospitals in that 

the EHR reporting period is aligned with 

the payment adjustment year, rather 

than in advance of the payment 

adjustment year. In the Stage 3 proposed 

rule, we propose a similar change to this 

definition for an EHR reporting period 

for a payment adjustment year 

beginning in 2017 and explain how this 

change to the calendar year would work 

for CAHs. For further discussion of this 

proposal, we direct readers to the Stage 

3 proposed rule (80 FR 16739 through 

16740). 

In this proposed rule, we propose a 

change to our current policy for 2015. 

We propose that for all CAHs, including 

those that have demonstrated 

meaningful use in a prior year and those 

that have not, the EHR reporting period 

for a payment adjustment year would be 

any continuous 90-day period beginning 

October 1, 2014 and ending December 

31, 2015. This EHR reporting period 

would apply for purposes of the 

payment adjustments for the cost 

reporting period that begins in federal 

FY 2015. We propose the deadline for 

attestation would be February 29, 2016. 

Any CAH that does not demonstrate 

meaningful for an EHR reporting period 

in 2015 would receive a downward 

adjustment to payments for its 

reasonable costs incurred in the cost 

reporting period that begins in federal 

FY 2015. If a CAH fails to demonstrate 

meaningful use in 2015 and has a fiscal 

year that ends between October 1, 2015 

and March 1, 2016, then the payment 

adjustment would be applied through 

the cost report reconciliation process. 

We also propose to change our current 

policy for 2016. We propose that if a 

CAH is demonstrating meaningful use 

for the first time in 2016, the EHR 

reporting period for a payment 

adjustment year would be any 

continuous 90-day period in CY 2016 

and apply for purposes of the payment 

adjustments for the cost reporting 

period that begins in federal FY 2016. 

The deadline for attestation would be 

February 28, 2017. If a CAH has 

previously demonstrated meaningful 

use, the EHR reporting period for a 

payment adjustment year would be the 

full CY 2016, the attestation deadline 

would be February 28, 2017, and this 

EHR reporting period would apply for 

purposes of the payment adjustments 

for the cost reporting period that begins 

in federal FY 2016. 

Any CAH that does not demonstrate 

meaningful for an EHR reporting period 

in 2016 would receive a downward 

adjustment to payments for its 

reasonable costs incurred in the cost 

reporting period that begins in federal 

FY 2016. If a CAH fails to demonstrate 

meaningful use in 2016 and has a fiscal 

year that ends between October 1, 2016 

and March 1, 2017, then the payment 

adjustment would be applied through 

the cost report reconciliation process. 

3. Hardship Exceptions 

As stated previously, sections 

1848(a)(7)(B) and 1886(b)(3)(B)(ix)(II) of 

the Act provide the Secretary with 

discretionary authority to exempt, on a 

case by case basis, a provider from the 

application of the Medicare payment 

adjustment if the Secretary determines 

that compliance with the requirements 

for being a meaningful EHR user would 

result in a significant hardship. We have 

established various types of hardship 

exceptions for which providers may 

apply as well as deadlines for 

application. For more information, we 

refer readers to the Stage 2 final rule at 

77 FR 54093 through 54113. 

In this proposed rule, we propose no 

changes to the existing hardship 

exceptions under our regulations. 

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 information collection 

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 IV.C.3.a. 

and b. of this proposed rule. The actual 

burden would remain constant for per 

year as EPs, eligible hospitals, and 

CAHs would need to attest that they 

have successfully demonstrated 

meaningful use under the proposed 

definition in 2015 through 2017. For the 

purposes of this analysis, we are 

focusing only on 2015, the first year in 

which a provider may use the proposed 

definition of meaningful use. We do not 

believe the burden for EPs, eligible 

hospitals, and CAHs participating in 

Stages 1 and 2 prior to 2015 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 had the option to 

electronically report their clinical 

quality measures through the respective 

aligned quality reporting programs; 

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however, for the purposes of defining 

the burden for 2015 through 2017, we 

maintain the estimates for attestation to 

CQM data. 

In this proposed rule, the definition of 

meaningful use with associated 

reporting requirements would replace 

all prior definitions and requirements 

beginning in 2015. At that point, all 

eligible providers would be required to 

report meaningful use requirements on 

an annual basis. For 2017, providers 

may simply repeat this proposed 

definition of meaningful use or move on 

to Stage 3. The same reporting burden 

would apply to all providers. 

Consequently, the proposed ICRs reflect 

the provider burden associated with 

complying with and reporting of the 

proposed requirements beginning in 

2015 and each subsequent year. We note 

that the proposals in this rule result in 

a reduction of the reporting burden on 

providers attesting to meaningful use as 

compared to the existing program 

requirements finalized in the Stage 2 

final rule (77 FR 54132). 

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 (§ 495.20 

Through § 495.60) 

In § 495.40 we propose that to 

successfully demonstrate meaningful 

use of certified EHR technology for 

meaningful use in 2015 through 2017, 

an EP, eligible hospital, or CAH 

(collectively referred to as ‘‘provider’’ in 

this section) must attest, through a 

secure mechanism in a specified 

manner, to the following during the 

EHR reporting period: (1) The provider 

used certified EHR technology and 

specified the technology was used; and 

(2) the provider satisfied each of the 

applicable objectives and associated 

measures in § 495.22. In § 495.40, 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 for 

which they are required to attest. 

We propose that EPs would be 

required to report on a total of 10 

objectives and associated measures and 

eligible hospitals and CAHs would 

report on a total of 9 objectives and 

associated measures. In this proposed 

rule, there are 6 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 6 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 2 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 approximately 1 

hour 30 minutes to attest to CQM 

requirements. 

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 3 

objectives that would require a ‘‘yes’’ or 

‘‘no’’ response during attestation. For 

eligible hospitals and CAHs, there are 2 

objectives and that would require a 

‘‘yes’’ or ‘‘no’’ response during 

attestation. We expect that it would take 

a provider or their designee 1 minute to 

attest to each objective that requires a 

‘‘yes’’ or ‘‘no’’ response. 

Providers would also be required to 

attest that they are protecting ePHI. 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 7 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 49 minutes to 

complete, and would take an eligible 

hospital or CAH 6 hours 48 minutes to 

complete. 

In this proposed rule EPs, eligible 

hospitals, and CAHs have nearly 

identical reporting burdens. Eligible 

hospitals and CAHs are required to 

report to one additional registry than 

EPs are required to report; however, EPs 

have an additional objective, Secure 

Electronic Messaging, which requires a 

‘‘yes’’ or ‘‘no’’ response. 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 7—BURDEN ESTIMATES

Eligible professionals Eligible hospitals and CAHs Measures 

Burden 

estimate per 

respondent 

(EPs) 

Burden 

estimate per 

respondent 

(hospitals) 

Objectives and Measures 

Use computerized provider 

order entry (CPOE) for medication, laboratory and radiology orders directly entered 

by any licensed healthcare 

professional who can enter 

orders into the medical record 

per state, local and professional guidelines.

Use computerized provider 

order entry (CPOE) for medication, laboratory and radiology orders directly entered 

by any licensed healthcare 

professional who can enter 

orders into the medical 

record per state, local and 

professional guidelines.

More than 60% of medication, 30% of 

laboratory, and 30% of radiology orders 

created by the EP or authorized providers of the eligible hospital’s or 

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

reporting period are recorded using 

CPOE.

10 minutes ..... 10 minutes. 

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TABLE 7—BURDEN ESTIMATES—Continued 

Eligible professionals Eligible hospitals and CAHs Measures 

Burden 

estimate per 

respondent 

(EPs) 

Burden 

estimate per 

respondent 

(hospitals) 

Generate and transmit permissible prescriptions electronically (eRx).More than 50% of all permissible prescriptions, or all prescriptions written by 

the EP and queried for a drug formulary and transmitted electronically 

using CEHRT.

10 minutes.

Generate and transmit permissible discharge prescriptions 

electronically (eRx).

More than 10% of hospital discharge 

medication orders for permissible prescriptions (for new, changed, and refilled prescriptions) are queried for a 

drug formulary and transmitted electronically using CEHRT.

10 minutes. 

Use clinical decision support to 

improve performance on highpriority health conditions.

Use clinical decision support to 

improve performance on 

high-priority health conditions.

1. Implement five clinical decision support 

interventions related to four or more 

clinical quality measures at a relevant 

point in care for the entire EHR reporting period. Absent four clinical quality 

measures related to an EP, eligible 

hospital or CAH’s scope of practice or 

patient population, the clinical decision 

support interventions must be related 

to improving healthcare efficiency.

2. The EP, eligible hospital or CAH has 

enabled and implemented the 

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

EHR reporting period.

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

Provide patients the ability to 

view online, download, and 

transmit their health information within 4 business days of 

the information being available to the EP.

1. More than 50% of all unique patients 

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

business days after the information is 

available to the EP) online access to 

their health information subject to the 

EP’s discretion to withhold certain information.

2. At least 1 patient seen by the EP during the EHR reporting period (or their 

authorized representatives) views, 

downloads, or transmits to a third party 

their health information.

10 minutes.

Provide patients the ability to 

view online, download, and 

transmit information about a 

hospital admission.

1. More than 50% of all patients who are 

discharged from the inpatient or emergency department (POS 21 or 23) of 

an eligible hospital or CAH have their 

information available online within 36 

hours of discharge.

2. At least 1 patient (or their authorized 

representatives) who are discharged 

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

hospital or CAH views, downloads or 

transmits to a third party their information during the reporting period.

10 minutes. 

Use CEHRT to identify patientspecific education resources 

and provide those resources 

to the patient.

Use CEHRT to identify patientspecific education resources 

and provide those resources 

to the patient.

Patient-specific education resources identified by CEHRT are provided to patients for more than 10% of all unique 

patients with office visits seen by the 

EP during the EHR reporting period.

More than 10% of all unique patients admitted to the eligible hospital’s or 

CAH’s inpatient or emergency departments (POS 21 or 23) are provided patient-specific education resources identified by CEHRT.

10 minutes ..... 10 minutes. 

Use secure electronic messaging to communicate with 

patients on relevant health information.

The secure electronic messaging function 

was fully enabled for the EHR reporting 

period.

10 minutes.

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TABLE 7—BURDEN ESTIMATES—Continued 

Eligible professionals Eligible hospitals and CAHs Measures 

Burden 

estimate per 

respondent 

(EPs) 

Burden 

estimate per 

respondent 

(hospitals) 

The EP who receives a patient 

from another setting of care 

or provider of care or believes 

an encounter is relevant 

should perform medication 

reconciliation.

The eligible hospital or CAH 

who receives a patient from 

another setting of care or 

provider of care or believes 

an encounter is relevant 

should perform medication 

reconciliation.

The EP, eligible hospital or CAH performs medication reconciliation for 

more than 50% of transitions of care in 

which the patient is transitioned into 

the care of the EP or admitted to the 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23).

10 minutes ..... 10 minutes. 

The EP who transitions their patient to another setting of care 

or provider of care or refers 

their patient to another provider of care provides a summary care record for each 

transition of care or referral.

The eligible hospital or CAH 

who transitions their patient 

to another setting of care or 

provider of care or refers 

their patient to another provider of care provides a 

summary care record for 

each transition of care or referral.

1. The EP, eligible hospital or CAH that 

transitions or refers their patient to another setting of care or provider of care 

provides a summary of care record for 

more than 10% of such transitions and 

referrals either (a) electronically transmitted using CEHRT to a recipient or 

(b) where the recipient receives the 

summary of care record via exchange 

facilitated by an organization that is a 

NwHIN Exchange participant or in a 

manner that is consistent with the governance mechanism ONC establishes 

for the nationwide health information 

network.

10 minutes ..... 10 minutes. 

Active engagement with a public health agency to report 

public health data.

Active engagement with a public health agency to report 

public health data.

EPs must attest to at least 2 options out 

of 5.

Eligible Hospitals and CAHs must attest 

to at least 3 options out of 6.

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

Protect electronic protected 

health information created or 

maintained by the CEHRT 

through the implementation of 

appropriate technical capabilities.

Protect electronic protected 

health information created or 

maintained by the CEHRT 

through the implementation 

of appropriate technical capabilities.

Conduct or review a security risk analysis 

in accordance with the requirements 

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

addressing the 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), and implement security 

updates as necessary and correct identified security deficiencies as part of the 

provider’s risk management process.

6 hours.

Time to Attest to Objectives and Measures ........................................................................................................... 6 hours 49 

minutes.

6 hours 48 

minutes. 

Time to Attest and Report Clinical Quality Measures ............................................................................................ 1 hour 30 minutes.1 hour 30 minutes. 

Total—Objectives + CQM Reporting ............................................................................................................... 8 hours 19 

minutes.

8 hours 18 

minutes. 

In this proposed rule, we estimate that 

it would take no longer than 6 hours 49 

minutes for an EP to attest to each of the 

applicable objectives and associated 

measures. The total burden hours for an 

EP to attest to the meaningful use 

objectives and measures and to report 

CQMs would be 8 hours 19 minutes. We 

estimate that there could be 

approximately 595,100 nonhospitalbased Medicare EPs in 2014. Based on 

the historical data, we anticipate 

approximately 60 percent (357,060) of 

these EPs may attest to the objectives 

and measures of meaningful use. In 

addition, we believe approximately 

30,000 Medicaid only EPs, or 

approximately 51 percent of the 

Medicaid-only EPs, will successfully 

demonstrate meaningful use in 2015. 

The total estimated annual cost burden 

for all EPs to attest to meaningful use 

would be $297,076,291 (387,060 × 8 

hours 19 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 meaningful use objectives and 

associated measures, and would submit 

the clinical quality measures. We 

estimate that it would take no longer 

than 6 hours 48 minutes to attest to each 

of the applicable objectives and 

associated measures. Therefore, the total 

burden hours for an eligible hospital or 

CAH to attest to the meaningful use 

objectives and measures and to report 

CQMs, would be 8 hours 18 minutes. 

We estimate that there are about 4,900 

eligible hospitals and CAHs that may 

attest to the aforementioned criteria in 

FY 2015 of which 95 percent are 

expected to successfully demonstrate 

meaningful use. The total estimated 

annual cost burden for all eligible 

hospitals and CAHs to attest to 

meaningful use would be $2,451,872 

(4,655 eligible hospitals and CAHs × 

$63.46 (8 hours 18 minutes × $63.46 

(mean hourly rate for lawyers based on 

May 2013 BLS) data)). 

We provide the estimate of the burden 

for the approximately 13,635 MA EPs in 

the MA organization burden section. 

The total annual burden estimates for 

meaningful use under this proposed 

rule are shown in Table 10. 

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For the purpose of this proposed 

collection of information, we assumed 

that all eligible providers would comply 

with the requirements of Meaningful 

Use as previously defined if the policies 

proposed in this rule were not finalized. 

Therefore, in this proposed rule, we 

estimate that the policies contained 

herein, once finalized, would result in 

an overall reduction in the reporting 

burden for providers of 1.45 hours to 1.9 

hours for EPs and 2.62 hours for eligible 

hospitals and CAHs per respondent. 

While batch reporting for objectives and 

measures, and group reporting for 

CQMs, are available for EPs in the 

current program; the program is based 

upon successful individual provider 

demonstration of meaningful use and so 

individual totals are used to identify the 

estimated reduction in provider 

reporting burden. This reduction of 

burden is outlined in Table 8. 

TABLE 8—REDUCTION IN REPORTING BURDEN HOURS

Burden under current program and proposed modifications Estimated burden per respondent 

EPs 

Estimated burden per respondent 

eligible hospitals and CAHs 

Total Under Current Stage 2 Requirements at 42 CFR 495.6 ...............

Core Set (including CQMs) + Least Burdensome Menu Set Criteria .....

9 hours 46 minutes ........................ NA. 

Total Under Current Stage 2 Requirements at 42 CFR 495.6 ...............

Core Set (including CQMs) + Most Burdensome Menu Set Criteria ......

10 hours 13 minutes ...................... 10 hours 55 minutes. 

Total Under Proposed Modifications at 495.22 ......................................

All Objectives and Measures + CQMs ....................................................

8 hours 19 minutes ........................ 8 hours 18 minutes. 

Reduction from Least Burdensome Estimate ......................................... 1 hour 27 minutes ......................... NA. 

Reduction from Most Burdensome Estimate .......................................... 1 hour 54 minutes ......................... 2 hour 37 minutes. 

Using the hourly costs associated with 

the reporting burden as mentioned 

previously, this reduction of 1.45 hours 

to 1.9 hours for EPs and 2.62 hours for 

eligible hospitals and CAHs represents a 

per response savings of $133.76 to 

$175.28 for EPs and $166.27 for eligible 

hospitals and CAHs. The total cost 

reduction in cost for providers 

demonstrating meaningful use is 

estimated at $48,534,332 at the lowest 

and $63,359,464 at the highest. These 

estimates are further outlined in Table 

9. 

TABLE 9—REDUCTION IN BURDEN COST SAVINGS

Number of responses Burden reduction 

hours Hourly cost Reduction per respondent 

Total cost 

reduction 

387,060 ............................................................................................ 1.45 $92.25 $133.76 $51,773,146 

387,060 ............................................................................................ 1.9 92.25 175.28 67,843,877 

4,655 ................................................................................................ 2.62 63.46 166.27 773,987 

Total Least ................................................................................ ............................ ............................ ............................ 52,547,132 

Total Most .......................................................................... ............................ ............................ ............................ 68,617,864 

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, 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 in masse if the 

certified EHR technology is required to 

be used at its facilities, whereas under 

FFS, each EP likely must make the 

determination on an individual basis. 

We further note, that these differences 

also mean the total reduction in burden 

for MA organizations resulting from the 

proposals in this rule would be 

negligible. 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 the 

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 with assumed 100 

percent successfully demonstrating 

meaningful use, we believe it would 

cost the participating qualifying MA 

organizations approximately $426,050 

annually to collect the required 

information and make the attestations 

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

$50.00]). 

C. ICRs Regarding State Medicaid 

Agency and Medicaid EP and Hospital 

Activities (§ 495.332 Through § 495.344) 

In this proposed rule, we are 

proposing no changes to State Medicaid 

Agency reporting which affect the time 

and effort associated with completing 

the single provider election repository 

and each state’s process for the 

administration of the Medicaid 

incentive payments, including tracking 

of attestations and oversight; the 

submission of the state Medicaid HIT 

Plan and the additional planning and 

implementation documents; or the 

enrollment or reenrollment of providers, 

or for the collection and submission of 

the data for providers to demonstrate 

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that they have adopted, implemented, or 

upgraded certified EHR technology. We 

believe the burden associated with these 

requirements has already been 

accounted for in our discussion in the 

Stage 1 and Stage 2 final rules at (75 FR 

44516 through 44544 and 77 FR 54125 

through 54135). For the collection and 

submission of the data for providers to 

demonstrate that they are meaningful 

users of such technology, we believe the 

burden associated with these 

requirements has already been 

accounted for in our discussion of the 

burden for § 495.20 through § 495.60. 

TABLE 10—ESTIMATED ANNUAL REPORTING BURDEN FOR MEANINGFUL USE

Regulation 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 

($) 

§ 495.22—Objectives/Measures/CQMs 

(EPs) ........................................................ 0938–1158 387,060 387,060 8 .32 3,220,339 $92.25 $297,076,291 

§ 495.22—Objectives/Measures/CQMs 

(hospitals/CAHs) ...................................... 0938–1158 4,655 4,655 8 .3 38,637 63.46 2,451,872 

§ 495.210—Gather Attestation Information 

(MA EPs and EHs) .................................. 0938–1158 13,635 13,635 0 .75 10,226 25.00 255,656 

§ 495.210—Attest (MA EPs and EHs) ........ 0938–1158 13,635 13,635 0 .25 3,409 50.00 170,438 

Total ..................................................... ........................ 418,985 418,985 .......................... 3,272,611 ........................ 299,954,257 

* To avoid double counting, this number of respondents is only included once in the total. 

** 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 10. 

If you would like to comment on 

these information collection and 

recordkeeping requirements, please do 

either of the following: 

1. Submit your comments 

electronically as specified in the 

ADDRESSES section of this proposed rule; 

or 

2. Submit your comments to the 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Attention: CMS Desk Officer, 

[CMS–3311–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. The proposed rule 

specifies applicable criteria for 

demonstrating meaningful use for an 

EHR reporting period in 2015 through 

2017. 

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). 

In relation to the existing program 

requirements outlined in the Stage 2 

final rule (77 FR 53967 through 54162), 

we do not expect this rule to result in 

more incentives paid or in more 

providers failing meaningful use and 

being assessed a payment adjustment. 

This is due to the nature of the 

modifications being proposed in this 

rule, which, while they reduce the 

reporting burden on providers, do not 

affect the clinical processes and IT 

functions required to successfully meet 

the objectives and measures of 

meaningful use. The proposals in this 

rule do not fundamentally change the 

technology required to support 

participation in the meaningful use 

program. Under the current program, 

the requirement to report data on the 

measures and objectives which have 

been identified as now redundant to 

other more advanced measures being 

retained, or are duplicative of other 

measures using the same certified EHR 

technology function, is essentially 

requiring providers to report on the 

same action or process twice. Therefore, 

it is not the occurrence of the action or 

process which is reduced by the 

proposals in this rule, but the burden 

associated with the duplicative and 

redundant reporting. In addition, the 

objectives and measures which are 

considered topped out have reached 

high performance and the statistical 

evidence demonstrates that the expected 

result of any provider attesting to 

meaningful use would be a score near 

the maximum. However, the analysis of 

these measures and their identification 

as topped out also takes into account the 

statistical likelihood that the functions 

of measures and the processes behind 

them would continue even without a 

requirement to report the results. 

Therefore, while the proposals result in 

a reduction in reporting requirements, 

this does not correlate to a change in the 

overall achievement of the measures 

and objective as compared to the current 

program. Finally, when compared 

against historical data, the shortened 

reporting period in 2015, which has 

been proposed to accommodate the 

implementation of the policies of this 

rule, is expected to have a minimal 

impact on successful demonstration of 

meaningful use. This expectation of 

minimal impact is based on a number of 

factors: 

• The shortened period is for 2015 

only and not for 2016 or 2017. 

• Historical data on attestations 

shows no strong correlation between a 

shorter reporting period and the ability 

of providers to attest to a second year of 

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5CMS Data and Reports: Quarterly Public Use 

Files for participation, Monthly Reports for 

performance rates: http://www.cms.gov/

Regulations-and-Guidance/Legislation/EHR

IncentivePrograms/DataAndReports.html. 

6CMS Data and Reports: Quarterly Public Use 

Files for participation, Monthly Reports for 

performance rates: http://www.cms.gov/

Regulations-and-Guidance/Legislation/EHR

IncentivePrograms/DataAndReports.html. 

meaningful use, no correlation for 

providers returning to attest to a third or 

fourth year of meaningful use, and 

providers who would otherwise be in 

their first year of meaningful use would 

already have a 90-day reporting period.5

• Performance data shows 

statistically negligible disparity among 

providers attesting for a 90-day 

reporting period and those attesting for 

a full year reporting period on the 

measures which have been identified as 

redundant, duplicative, and topped 

out.6

For these reasons, we do not believe 

the proposals in this rule would impact 

the overall estimates for incentive 

payments, payment adjustments, and 

the net transfer costs associated with the 

program. However, these proposals do 

affect the costs associated with the 

reporting burden on providers. The 

impacts directly attributable with the 

proposals in this rule relate to both an 

hourly reduction per response an 

overall reduction in the cost associated 

with reporting for providers 

demonstrating meaningful use. The 

burden analysis in this proposed rule, as 

compared to the Stage 2 estimates, 

reduces the reporting burden for 

attestation for providers by 

approximately 1.45 hours to 1.9 hours 

for EPs and 2.62 hours for eligible 

hospitals and CAHs per respondent. 

This burden estimate and analysis of the 

impact of the policies result in a total 

cost reduction estimated at $48,534,332 

at the lowest and $63,359,464 at the 

highest. However, we believe this 

proposed rule will have additional 

impacts—most notably, cost savings for 

hospitals and providers that would have 

additional time to achieve meaningful 

use—which cannot be adequately 

estimated because of the wide variation 

among provider types, and therefore a 

designation as an economically 

significant rule under the Executive 

Order and a major rule under the 

Congressional Review Act is still 

applicable. The burden estimate and 

analysis of the impact of the policies 

proposed in this proposed rule are 

outlined further in section III. of this 

proposed rule. 

1. Overall Effects 

a. Regulatory Flexibility Analysis and 

Small Entities 

The Regulatory Flexibility Act (RFA) 

requires agencies to prepare an Initial 

Regulatory Flexibility Analysis to 

describe and analyze the impact of the 

proposed rule on small entities unless 

the Secretary can certify that the rule 

will not have a significant impact on a 

substantial number of small entities. In 

the healthcare sector, Small Business 

Administration (SBA) size standards 

define a small entity as one with 

between $7 million and $34 million in 

annual revenues. For the purposes of 

the RFA, essentially all non-profit 

organizations are considered small 

entities, regardless of size. Individuals 

and states are not included in the 

definition of a small entity. Since the 

vast majority of Medicare providers 

(well over 90 percent) are small entities 

within the RFA’s definitions, it is the 

normal practice of HHS simply to 

assume that all affected providers are 

‘‘small’’ under the RFA. In this case, 

most EPs, eligible hospitals, and CAHs 

are either nonprofit or meet the SBA’s 

size standard for small business. We 

also believe that the effects of the 

incentives program on many and 

probably most of these affected entities 

will be economically significant. 

Accordingly, this RIA section, in 

conjunction with the remainder of the 

preamble, constitutes the required 

Initial Regulatory Flexibility Analysis 

(RFA). 

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. As of January 1, 

2015, more than 95 percent of eligible 

hospitals had successfully demonstrated 

meaningful use. 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 with over 

60 percent earning an incentive 

payment for participation in the 

program prior to 2015. 

The cost reductions provided by the 

proposals in this rule offer a benefit to 

these providers. Furthermore, 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) 

would demonstrate the actual costs 

incurred by providers participating in 

the EHR Incentive Programs. The 

potential costs savings in this proposed 

rule would benefit these providers as a 

reduction in the overall cost of program 

participation. 

(2) Conclusion 

As discussed later in this analysis, we 

believe that there are many positive 

effects of adopting EHR on health care 

providers. Furthermore, we believe that 

the proposals in this rule will result in 

an overall reduction in the reporting 

burden for providers of all types. 

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 

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20388 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 

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. There is no identifiable disparity 

among this group and the overall 

success rates for eligible hospitals and 

CAHs in demonstrating meaningful use; 

furthermore, 95 percent of eligible 

hospitals and CAHs have successfully 

demonstrated meaningful use as of 

January 1, 2015. Finally, on the whole 

we anticipate an estimated reduction in 

the reporting burden on eligible 

hospitals as a group to be less than $1 

million. Therefore, we do not believe 

that this proposed rule would have a 

significant impact on a substantial 

number of small entities. 

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 2015, that threshold is 

approximately $144 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 

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. In addition, the changes being 

made by this proposed rule have very 

little impact on any state functions. 

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 would not have a 

substantial direct effect on state or local 

governments, preempt state law, or 

otherwise have a Federalism 

implication. 

2. Effects on EPs, Eligible Hospitals, and 

CAHs 

a. Background and Assumptions 

There are no new costs associated 

with this proposed rule. Furthermore, 

the estimates for the provisions affecting 

Medicare and Medicaid EPs, eligible 

hospitals, and CAHs are somewhat 

uncertain for the following reasons: 

• The program is voluntary although 

payment adjustments will be imposed 

on Medicare providers if they are unable 

to demonstrate meaningful use for the 

applicable reporting period. 

• The potential reduction in burden 

for EPs rely on relate to assumptions of 

what options for meaningful use they 

would otherwise attest to should the 

policies in this proposed rule not be 

adopted. 

• The net costs and savings for any 

individual provider may not directly 

correlate to the total for the organization 

as larger organizations may employ 

economies of scale in meaningful use 

attestations. 

However, based on the actual count of 

providers eligible for the program as of 

December 31, 2014 which were 

identified through the process of 

implementing payment adjustments for 

2015, we estimated the numbers of EPs 

and eligible hospitals, including CAHs 

under Medicare, Medicaid, and MA for 

2015 through 2017 and used the 

updated estimates throughout the 

analysis. These total potential eligible 

providers are as follows: 

• About 660,000 Medicare FFS EPs 

(some of whom will also be Medicaid 

EPs). About 595,100 non-hospital based 

Medicare EPs. 

• About 58,300 non-Medicare eligible 

EPs (such as dentists, pediatricians, and 

eligible non-physicians such as certified 

nurse-midwives, nurse practitioners, 

and physicians assistants). 

• 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). 

• 16 MA organizations and 13,635 

MA EPs 

b. Industry Costs and Adoption Rates 

In this proposed rule, we are 

proposing no new policies which would 

require changes to the development, 

certification, and implementation of 

certified EHR technology as compared 

to the policies in the existing program 

outlined in the Stage 2 final rule (77 FR 

54136 through 54146). 

3. Medicare Incentive Program Costs 

As noted at the beginning of this 

analysis, it is difficult to predict the 

actual impacts of the policies in this 

proposed rule with certainty. We 

believe the assumptions and methods 

described herein are reasonable for 

estimating the financial impact of the 

provisions on providers participating in 

the Medicare and Medicaid programs, 

but acknowledge the wide range of 

possible outcomes. 

a. Medicare Eligible Professionals (EPs) 

In brief, the estimates of Medicare EP 

burden reduction are based on current 

participation as of January 1, 2015. We 

estimate that significant cost reductions 

for Medicare EPs participating in the 

EHR Incentive Program will result from 

the policies in this proposed rule when 

compared to the requirements of the 

current program. Our estimates of the 

reduction in burden cost savings are 

presented in Table 12. They reflect our 

assumptions about the proportion of EPs 

who will demonstrate meaningful use of 

certified EHR technology outlined in 

Table 11 based on historical data. 

TABLE 11—MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY

Calendar year 

2015 2016 2017 

Medicare EPs who have claims with Medicare (in thousands) ................................ 660 .0 667 .8 675 .5 

Nonhospital-based Medicare EPs (in thousands) ..................................................... 595 .1 602 .1 609 .1 

Percent of EPs who are Meaningful Users ............................................................... 60 65 70 

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TABLE 11—MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY—Continued 

Calendar year 

2015 2016 2017 

Meaningful Users (in thousands) ............................................................................... 357 .1 391 .4 426 .4 

TABLE 12—ESTIMATED COST REDUCTION FOR MEDICARE EPS

Calendar year 

2015 2016 2017 

Meaningful Users (in thousands) ............................................................................... 357 .1 391 .4 426 .4 

Lowest Estimated Cost Savings ................................................................................ $47,760,345 .60 $52,353,664 .00 $57,035,264 .00 

Highest Estimated Cost Savings ............................................................................... $62,585,476 .80 $68,604,592 .00 $74,739,392 .00 

b. Medicare Eligible Hospitals and 

CAHs 

In brief, the estimates of hospital 

burden reduction are based on current 

participation as of January 1, 2015. We 

estimate that significant cost reductions 

for Medicare eligible hospitals and 

CAHs participating in the EHR Incentive 

Program would result from the policies 

in this proposed rule when compared to 

the requirements of the current program. 

Our estimates of the reduction in 

burden cost savings are presented in 

Table 12. They reflect our assumptions 

about the proportion of eligible 

hospitals and CAHs that will 

demonstrate meaningful use of certified 

EHR technology outlined in Table 13 

based on historical data. 

TABLE 13—MEDICARE ELIGIBLE HOSPITALS AND CAHS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR 

TECHNOLOGY

Calendar year 

2015 2016 2017 

Eligible Hospitals ............................................................................................................. 3,397 3,397 3,397 

CAHs ................................................................................................................................ 1,395 1,395 1,395 

Percent Demonstrating Meaningful Use .......................................................................... 95 97 99 

Meaningful Users ............................................................................................................. 4,552 4,648 4,744 

TABLE 14—ESTIMATED COST REDUCTION FOR MEDICARE ELIGIBLE HOSPITALS AND CAHS

Calendar year 

2015 2016 2017 

Meaningful Users ....................................................................................................... 4,552 4,648 4,744 

Estimated Cost Savings ............................................................................................ $756,861 .04 $772,822 .96 $788,784 .88 

4. Medicaid Only EPs 

We estimate that significant cost 

reductions for Medicaid only EPs 

participating in the EHR Incentive 

Program will result from the policies in 

this proposed rule when compared to 

the requirements of the current program. 

Our estimates of the reduction in 

burden cost savings are presented in 

Table 16. They reflect our assumptions 

about the proportion of Medicaid only 

EPs who will demonstrate meaningful 

use of certified EHR technology outlined 

in Table 15 based on historical data. 

TABLE 15—MEDICAID ONLY EPS DEMONSTRATING MEANINGFUL USE

Calendar year 

2015 2016 2017 

Medicaid only EPs ..................................................................................................... 58 .3 59 .4 60 .6 

Percent of EPs who are Meaningful Users ............................................................... 51 53 55 

Meaningful Users (in thousands) ............................................................................... 30 31 .48 33 .33 

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TABLE 16—ESTIMATED COST REDUCTION FOR MEDICAID ONLY EPS

Calendar year 

2015 2016 2017 

Meaningful Users (in thousands) ............................................................................... 30,000 31,480 33,330 

Lowest Estimated Cost Savings ................................................................................ $4,012,800 .00 $4,210,764 .80 $4,458,220 .80 

Highest Estimated Cost Savings ............................................................................... $5,258,400 .00 $5,517,814 .40 $5,842,082 .40 

It should be noted that since the 

Medicaid EHR Incentive Program 

provides that a Medicaid EP can receive 

an incentive payment in their first year 

because he or she has demonstrated a 

meaningful use or because he or she has 

adopted, implemented, or upgraded 

certified EHR technology, these 

participation rates include only those 

Medicaid providers who are expected to 

demonstrate meaningful use. Providers 

who are dual-eligible have been 

included in the Medicare EP program 

estimates based on the total current 

volume of Medicare EPs who have 

demonstrated meaningful use in either 

Medicare or Medicaid as of January 1, 

2015. 

b. Medicaid Only Hospitals 

The burden reduction for Medicaid 

only eligible hospitals assumes a similar 

participation rate for the demonstration 

of meaningful use as is applicable for 

Medicare eligible hospitals. We estimate 

that significant cost reductions for 

Medicaid only eligible hospitals 

participating in the EHR Incentive 

Program will result from the policies in 

this proposed rule when compared to 

the requirements of the current program. 

Our estimates of the reduction in 

burden cost savings are presented in 

Table 18. They reflect our assumptions 

about the proportion of Medicaid only 

eligible hospitals that will demonstrate 

meaningful use of certified EHR 

technology outlined in Table 17 based 

on historical data. 

TABLE 17—MEDICAID ONLY ELIGIBLE HOSPITALS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY

Calendar year 

2015 2016 2017 

Eligible Hospitals ............................................................................................................. 108 108 108 

Percent Demonstrating Meaningful Use .......................................................................... 95 97 99 

Meaningful Users ............................................................................................................. 103 105 107 

TABLE 18—ESTIMATED COST REDUCTION FOR MEDICARE ELIGIBLE HOSPITALS AND CAHS

Calendar year 

2015 2016 2017 

Meaningful Users ............................................................................................................. 4,552 4,648 4,744 

Estimated Cost Savings .................................................................................................. $17,125.81 $17,458.35 $17,790.89 

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 at 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 

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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. The proposals in this 

rule focus on a long term goal of moving 

providers along a continuum from data 

capture to advanced use of certified 

EHR technology. The reduction of 

reporting burden recognizes progress 

toward key milestones and is intended 

to allow providers to refocus on 

leveraging health IT to support health 

information exchange, patient 

engagement, and quality improvement. 

As participation and adoption increases, 

there will be more opportunities to 

capture and report on cost savings and 

benefits. 

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 

regulation are even harder to quantify 

because they represent, in many cases, 

the reduction in the time spent per each 

individual respondent to attest to the 

meaningful use objectives and 

measures. While this time may 

represent a reduced burden and the 

opportunity to reallocate recourses, 

there is no viable way to estimate that 

benefit over a wide range of provider 

types, practice sizes and other potential 

variables. For example, the reduction of 

about 2 hours per respondent for a small 

practice might be insignificant; 

however, for a practice of 1,000 

providers it may represent as many as 

2,000 man hours which could be 

reallocated to making other 

improvements in clinical processes and 

patient outcomes. Conversely, a large 

practice may instead leverage the batch 

reporting option and only see an overall 

reduction of 20 man hours as an 

organization while a small practice may 

find an even greater reduction than the 

estimate which may amount to a 

significantly increased benefit and more 

time for the provider to spend in patient 

care. 

In the Stage 2 final rule, 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,, 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.’’ 

C. Accounting Statement 

Whenever a rule is considered a 

significant rule under Executive Order 

12866, we are required to develop an 

accounting statement indicating the 

classification of the expenditures 

associated with the provisions of this 

proposed rule. This rule is considered 

economically significant as mentioned 

previously because the impacts directly 

attributable with the proposals in this 

rule would result in an overall 

reduction in the reporting burden and 

associated costs for providers 

demonstrating meaningful use. 

Monetary annualized benefits and 

nonbudgetary costs are presented as 

discounted flows using 3 percent and 7 

percent factors. 

TABLE 19—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED COST REDUCTIONS AND BENEFITS CYS 2015 

THROUGH 2017 

[In millions] 

Category 

Benefits 

Low estimate High estimate 

Annualized Monetized Cost Reductions to Private Industry 

Associated with Reporting Requirements.

2015 52.8 

52.8 

68.9 

68.9 

7% 

3% 

CY 2015 

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TABLE 19—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED COST REDUCTIONS AND BENEFITS CYS 2015 

THROUGH 2017—Continued 

[In millions] 

Category 

Benefits 

Low estimate High estimate 

Qualitative—Other private industry and societal benefits 

associated with the reduction in provider reporting burden and with having additional time to achieve meaningful use.

In this proposed rule, there is no 

estimated increase in costs associated 

with incentive payments or payment 

adjustments for the Medicare and 

Medicaid EHR Programs attributable to 

the proposed policies. 

D. Conclusion 

The previous analysis, together with 

the remainder of this preamble, 

provides an RIA. We invite public 

comments on the analysis and request 

any additional data that will help us 

determine more accurately the impact 

on the EPs and eligible hospitals 

affected by the proposed rule and on 

Medicare and Medicaid payments to 

these entities. 

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 further 

amend 42 CFR part 495, as previously 

proposed to be amended on March 30, 

2015 (80 FR 16732), as follows: 

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. Amend the definition of ‘‘EHR 

reporting period’’ by: 

■ i. In paragraph (1)(i) introductory text 

removing the phrase ‘‘before CY 2017’’ 

and adding in its place the phrase 

‘‘before CY 2015’’. 

■ ii. Redesignating paragraph (1)(ii) as 

paragraph (1)(iii). 

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

■ iv. In paragraph (2)(i) introductory 

text removing the phrase ‘‘before CY 

2017’’ and adding in its place the phrase 

‘‘before CY 2015’’. 

■ v. Redesignating paragraph (2)(ii) as 

paragraph (2)(iii). 

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

■ B. Amend the definition of ‘‘EHR 

reporting period for a payment 

adjustment year’’ by: 

■ i. In paragraph (1)(i) introductory text 

removing the phrase ‘‘before CY 2017’’ 

and adding in its place the phrase 

‘‘before 2015’’. 

■ ii. Redesignating paragraph (1)(ii) as 

paragraph (1)(iii). 

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

■ iv. In paragraph (2)(i) introductory 

text removing the phrase ‘‘before CY 

2017’’ and adding in its place the phrase 

‘‘before CY 2015’’. 

■ v. Redesignating paragraph (2)(ii) as 

paragraph (2)(iii). 

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

■ vii. In paragraph (3)(i) introductory 

text removing the phrase ‘‘before CY 

2017’’ and adding in its place the phrase 

‘‘before CY 2015’’. 

■ viii. Redesignating paragraph (3)(ii) as 

paragraph (3)(iii). 

■ ix. Adding a new paragraph (3)(ii). 

■ C. Amend the definition of 

‘‘Meaningful EHR user’’ by: 

■ i. In paragraph (1), by removing the 

reference ‘‘§ 495.8’’ and adding in its 

place the reference ‘‘§§ 495.40’’. 

■ ii. In paragraph (1), by removing the 

reference ‘‘§ 495.6 or 495.7’’ and adding 

in its place the reference ‘‘§§ 495.20, 

495.22, and 495.24’’. 

The additions read as follows: 

§ 495.4 Definitions. 

* * * * * 

EHR reporting period. * * * 

(1) * * * 

(ii) The following are applicable for 

2015 and 2016: 

(A) For the CY 2015 payment year, 

any continuous 90-day period within 

CY 2015. 

(B) For the CY 2016 payment year: 

(1) For the EP first demonstrating he 

or she is a meaningful EHR user, any 

continuous 90-day period within CY 

2016. 

(2) For the EP who has successfully 

demonstrated he or she is a meaningful 

EHR user in any prior year, the CY 2016. 

* * * * * 

(2) * * * 

(ii) The following are applicable for 

2015 and 2016: 

(A) For the FY 2015 payment year, 

any continuous 90-day period within 

the period beginning October 1, 2014 

and ending December 31, 2015. 

(B) For the FY 2016 payment year for 

the eligible hospital or CAH— 

(1) First demonstrating it is a 

meaningful EHR user, any continuous 

90-day period within CY 2016; or 

(2) That has successfully 

demonstrated it is a meaningful EHR 

user in any prior year, the CY 2016. 

* * * * * 

EHR reporting period for a payment 

adjustment year * * * 

(1) * * * 

(ii) The following are applicable for 

2015 and 2016: 

(A) For an EHR reporting period in 

2015: 

(1) Except as specified under 

paragraph (1)(ii)(A)(2) of this definition, 

any continuous 90-day period within 

the calendar year that is 2 years before 

the payment adjustment year. 

(2) If in the calendar year that is 2 

years before the payment adjustment 

year and in all prior calendar years, the 

EP has not successfully demonstrated he 

or she is a meaningful EHR user, then 

any continuous 90-day period within 

the calendar year that is 1 year before 

the payment adjustment year. The EP 

must successfully register for and attest 

to meaningful use by February 29, 2016. 

(B) For an EHR reporting period in 

2016: 

(1) Except as specified in paragraphs 

(1)(ii)(B)(2) and (3) of this definition, the 

calendar year that is 2 years before the 

payment adjustment year. 

(2) If an EP is demonstrating he or she 

is a meaningful EHR user for the first 

time in the calendar year that is 2 years 

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before the payment adjustment year, 

then any continuous 90-day period 

within such (2 years prior) calendar 

year. 

(3) If in the calendar year that is 2 

years before the payment adjustment 

year and in all prior calendar years, the 

EP has not successfully demonstrated he 

or she is a meaningful EHR user, then 

any continuous 90-day period that both 

begins in the calendar year 1 year before 

the payment adjustment year and ends 

at least 3 months before the end of such 

prior year. The EP must successfully 

register for and attest to meaningful use 

by October 1, 2016. 

* * * * * 

(2) * * * 

(ii) The following are applicable for 

2015 and 2016: 

(A) For an EHR reporting period in 

2015: 

(1) Except as specified in paragraph 

(2)(ii)(A)(2) of this definition, any 

continuous 90-day period within the 

period beginning on October 1, 2014 

and ending on the last day of the 

calendar year that is 2 years before the 

payment adjustment year. 

(2) If in the calendar year that is 2 

years before the payment adjustment 

year and in all prior years, the eligible 

hospital has not successfully 

demonstrated it is a meaningful EHR 

user, then any continuous 90-day period 

within the period beginning on October 

1, 2014 and ending on the last day of the 

calendar year that is 1 year prior to the 

payment adjustment year. The eligible 

hospital must successfully register for 

and attest to meaningful use by 

February 29, 2016. 

(B) For an EHR reporting period in 

2016: 

(1) Except as specified in paragraphs 

(2)(ii)(B)(2) and (3) of this definition, the 

calendar year that is 2 years before the 

payment adjustment year. 

(2) If an eligible hospital is 

demonstrating 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 any 

continuous 90-day period within such 

(2 years prior) calendar year. 

(3) If in the calendar year that is 2 

years before the payment adjustment 

year and in all prior years, the eligible 

hospital has not successfully 

demonstrated it is a meaningful EHR 

user, then any continuous 90-day period 

that both begins in the calendar year 

that is 1 year before the payment 

adjustment year and ends at least 3 

months before the end of such prior 

calendar year. The eligible hospital 

must successfully register for and attest 

to meaningful use by October 1, 2016. 

* * * * * 

(3) * * * 

(ii) The following are applicable for 

2015 and 2016: 

(A) The EHR reporting period for the 

FY 2015 payment adjustment year is 

any continuous 90-day period within 

the period beginning on October 1, 2014 

and ending on December 31, 2015. The 

CAH must successfully register for and 

attest to meaningful use by February 29, 

2016. 

(B) For an EHR reporting period in 

2016: 

(1) Except as provided in paragraph 

(3)(ii)(B)(2) of this definition, the CY 

2016 is the EHR reporting period for the 

FY 2016 payment adjustment year. 

(2) If the CAH is demonstrating it is 

a meaningful EHR user for the first time, 

the EHR reporting period for the FY 

2016 payment adjustment year is any 

continuous 90-day period within CY 

2016. 

* * * * * 

§ 495.6 [Redesignated as § 495.20] 

■ 3. Redesignate § 495.6 as § 495.20. 

■ 4. Newly redesignated § 495.20 is 

amended by revising the section 

heading and adding new introductory 

text to read as follows. 

§ 495.20 Meaningful use objectives and 

measures for EPs, eligible hospitals, and 

CAHs before 2015. 

The following criteria are applicable 

before 2015: 

* * * * * 

■ 5. Add § 495.22 to read as follows: 

§ 495.22 Meaningful use objectives and 

measures for EPs, eligible hospitals, and 

CAHs for 2015 through 2017. 

(a) General rules. (1) The criteria 

specified in this section are applicable 

for all EPs, eligible hospitals, and CAHs 

for 2015 through 2017. 

(2) For 2017 only, EPs, eligible 

hospitals, and CAHs have the option to 

use the criteria specified for 2018 (as 

outlined at § 495.24) instead of the 

criteria specified in this section. 

(b) Criteria for EPs for 2015 through 

2017—(1) General rule regarding criteria 

for meaningful use for 2015 through 

2017 for EPs. Except as specified in 

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

must meet all objectives and associated 

measures of the meaningful use criteria 

specified under paragraph (e) of this 

section to meet the definition of a 

meaningful EHR user. 

(2) Exclusion for nonapplicable 

objectives. (i) An EP may exclude a 

particular objective contained in 

paragraph (e) of this section, if the EP 

meets all of the following requirements: 

(A) Must ensure that the objective in 

paragraph (e) of this section includes an 

option for the EP to attest that the 

objective is not applicable. 

(B) Meets the criteria in the applicable 

objective that would permit the 

attestation. 

(C) Attests. 

(ii) An exclusion will reduce (by the 

number of exclusions applicable) the 

number of objectives that would 

otherwise apply in paragraph (e) of this 

section. 

(c) Criteria for eligible hospitals and 

CAHs for 2015 through 2017—(1) 

General rule regarding criteria for 

meaningful use for 2015 through 2017 

for eligible hospitals and CAHs. Except 

as specified in paragraph (c)(2) of this 

section, eligible hospitals and CAHs 

must meet all objectives and associated 

measures of the meaningful use criteria 

specified under paragraph (e) of this 

section to meet the definition of a 

meaningful EHR user. 

(2) Exclusion for nonapplicable 

objectives. (i) An eligible hospital or 

CAH may exclude a particular objective 

contained in paragraph (e) of this 

section, if the eligible hospital or CAH 

meets all of the following requirements: 

(A) Must ensure that the objective in 

paragraph (e) of this section includes an 

option for the eligible hospital or CAH 

to attest that the objective is not 

applicable. 

(B) Meets the criteria in the applicable 

objective that would permit the 

attestation. 

(C) Attests. 

(ii) An exclusion will reduce (by the 

number of exclusions applicable) the 

number of objectives that would 

otherwise apply in paragraph (e) of this 

section. 

(d) Many of the objectives and 

associated measures in paragraph (e) of 

this section rely on measures that count 

unique patients or actions. (1) If a 

measure (or associated objective) in 

paragraph (e) of this section references 

paragraph (d) 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 (d) of this section, then the 

measure must be calculated by 

reviewing all patient records, not just 

those maintained using certified EHR 

technology. 

(e) Meaningful use objectives and 

measures for 2015 through 2017—(1) 

Protect patient health information—(i) 

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Objective. Protect electronic protected 

health information created or 

maintained by the Certified EHR 

Technology through the implementation 

of appropriate technical capabilities. 

(ii) Measures—(A) EP measure. 

Conduct or review a security risk 

analysis in accordance with the 

requirements in 45 CFR 164.308(a)(1), 

including addressing the security (to 

include encryption) of ePHI created or 

maintained in Certified EHR 

Technology in accordance with 

requirements under 45 CFR 

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

164.306(d)(3), and implement security 

updates as necessary and correct 

identified security deficiencies as part 

of the EP’s risk management process. 

(B) Eligible hospital or CAH measure. 

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 ePHI 

created or maintained in Certified EHR 

Technology in accordance with 

requirements under 45 CFR 

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

164.306(d)(3), and implement security 

updates as necessary and correct 

identified security deficiencies as part 

of the eligible hospital’s or CAH’s risk 

management process. 

(2) Clinical decision support—(i) 

Objective. Use clinical decision support 

to improve performance on high-priority 

health conditions. 

(ii) EP measures—(A) Measure. In 

order for EPs to meet the objective they 

must satisfy both of the following 

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 related to 

an EP’s scope of practice or patient 

population, the clinical decision 

support interventions must be related to 

high-priority health conditions. 

(2) Enabled and implemented the 

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

EHR reporting period. 

(B) Exclusion in accordance with 

paragraph (b)(2) of this section. An EP 

who writes fewer than 100 medication 

orders during the EHR reporting period 

may be excluded from the measure 

under paragraph (e)(2)(i)(A)(2) of this 

section. 

(C) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015—(1) Alternate exclusion. 

An EP previously scheduled to be in 

Stage 1 in 2015 may meet an alternate 

measure specified in paragraph 

(e)(2)(ii)(C)(2) in place of the measure 

outlined under paragraph (e)(2)(ii)(A)(1) 

of this section. 

(2) Alternate objective and measure— 

(i) Alternate objective. Implement one 

clinical decision support rule relevant 

to specialty or high clinical priority 

along with the ability to track 

compliance with that rule. 

(ii) Alternate measure. Implement one 

clinical decision support rule. 

(iii) Eligible hospital and CAH 

measures—(A) Measure. In order for 

eligible hospitals and CAHs to meet the 

objective they must satisfy both of the 

following 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 related to 

an eligible hospital or CAH’s scope of 

practice or patient population, the 

clinical decision support interventions 

must be related to high-priority health 

conditions. 

(2) Enabled and implemented the 

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

EHR reporting period. 

(B) Alternate specifications for an 

EHR reporting period in 2015—(1) 

Alternate objective and measure. An 

eligible hospital or CAH previously 

scheduled to be in Stage 1 in 2015 may 

meet an alternate measure described in 

paragraph (e)(2)(iii)(B)(2) of this section 

in place of the measure described in 

paragraph (e)(2)(iii)(A)(1) of this section. 

(i) Objective. Implement one clinical 

decision support rule related to a high 

priority hospital condition along with 

the ability to track compliance with that 

rule. 

(ii) Measure. Implement one clinical 

decision support rule. 

(3) Computerized provider order 

entry—(i) Objective. Use computerized 

provider order entry for medication, 

laboratory, and radiology orders directly 

entered by any licensed healthcare 

professional who can enter orders into 

the medical record per State, local, and 

professional guidelines. 

(ii) EP measures—(A) Measures. An 

EP must meet the following 3 measures, 

subject to paragraph (d) of this section: 

(1) More than 60 percent of 

medication orders created by the EP 

during the EHR reporting period are 

recorded using computerized provider 

order entry. 

(2) More than 30 percent of laboratory 

orders created by the EP during the EHR 

reporting period are recorded using 

computerized provider order entry. 

(3) More than 30 percent of radiology 

orders created by the EP during the EHR 

reporting period are recorded using 

computerized provider order entry. 

(B) Exclusion in accordance with 

paragraph (b)(2) of this section. (1) For 

the measure specified in paragraph 

(e)(3)(ii)(A)(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 (e)(3)(ii)(A)(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 (e)(3)(ii)(A)(3) of this section, 

any EP who writes fewer than 100 

radiology orders during the EHR 

reporting period. 

(C) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015—(1) An EP previously 

scheduled to be in Stage 1 in 2015 may 

meet an alternate measure (e)(3)(ii)(C)(2) 

in place of the measure outlined under 

paragraph (e)(3)(ii)(A)(1) of this section, 

and may exclude the measures outlined 

under paragraphs (e)(3)(ii)(A)(2) and (3) 

of this section. 

(2) Subject to paragraph (d) of this 

section— 

(i) More than 30 percent of all unique 

patients with at least one medication in 

their medication list seen by the EP 

during the EHR reporting period have at 

least one medication order entered 

using CPOE; or 

(ii) More than 30 percent of 

medication orders created by the EP 

during the EHR reporting period are 

recorded using computerized provider 

order entry. 

(3) Alternate exclusions. An EP 

previously scheduled to be in Stage 1 in 

2015 may exclude the measure— 

(i) Specified in paragraph 

(e)(3)(ii)(A)(2) of this section for an EHR 

reporting period in 2015. 

(ii) Specified in paragraph 

(e)(3)(ii)(A)(3) of this section for an EHR 

reporting period in 2015. 

(iii) Eligible hospital and CAH 

measures—(A) An eligible hospital or 

CAH must meet the following 3 

measures, subject to paragraph (d) of 

this section: 

(1) More than 60 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) More than 30 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. 

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(3) More than 30 percent of radiology 

orders created by authorized providers 

of the eligible hospital’s or CAH’s 

inpatient or emergency department 

(POS 21 or 23) during the EHR reporting 

period are recorded using computerized 

provider order entry. 

(B) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015. (1) An eligible hospital 

or CAH previously scheduled to be in 

Stage 1 in 2015 may— 

(i) Meet an alternate measure 

specified in paragraph (e)(3)(iii)(B)(2) of 

this section in place of the measure 

outlined under paragraph 

(e)(3)(iii)(A)(1) of this section; and 

(ii) May exclude the measures 

outlined under paragraphs 

(e)(3)(iii)(A)(2) and (e)(3)(iii)(A)(3) of 

this section. 

(2) Alternate measure 1. Subject to 

paragraph (d) of this section, 

(i) More than 30 percent of all unique 

patients with at least one medication in 

their medication list admitted to the 

eligible hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23) 

have at least one medication order 

entered using CPOE; or 

(ii) More than 30 percent of 

medication orders created by the 

authorized providers of the eligible 

hospital or CAH for patients admitted to 

their inpatient or emergency 

departments (POS 21 or 23) during the 

EHR reporting period are recorded using 

computerized provider order entry. 

(3) Alternate exclusions. An eligible 

hospital or CAH previously scheduled 

to be in Stage 1 in 2015 may exclude the 

measure specified— 

(i) In paragraph (e)(3)(iii)(A)(2) of this 

section for an EHR reporting period in 

2015; or 

(ii) In paragraph (e)(3)(iii)(A)(3) of this 

section for an EHR reporting period in 

2015. 

(4) Electronic prescribing—(i) 

Objective. For EPs, generate and 

transmit permissible prescriptions 

electronically (eRx); and, for eligible 

hospitals and CAHs, generate and 

transmit permissible discharge 

prescriptions electronically (eRx). 

(ii) EP measure—(A) Measure. Subject 

to paragraph (d) of this section, more 

than 50 percent of all permissible 

prescriptions, or all prescriptions, 

written by the EP are queried for a drug 

formulary and transmitted electronically 

using Certified EHR Technology. 

(B) Exclusion in accordance with 

paragraph (b)(2) of this section. Any EP 

who— 

(1) Writes fewer than 100 permissible 

prescriptions during the EHR reporting 

period; or 

(2) Does not have a pharmacy within 

his or her 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. 

(C) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015. An EP previously 

scheduled to be in Stage 1 in 2015 may 

meet an alternate measure under 

paragraph (e)(4)(ii)(C)(2) of this section 

in place of the measure outlined under 

paragraph (e)(4)(ii)(A) of this section. 

(1) Alternate measure. Subject to 

paragraph (d) of this section, more than 

40 percent of all permissible 

prescriptions written by the EP are 

transmitted electronically using 

Certified EHR Technology. 

(2) Alternate exclusion. There are no 

alternate exclusions for this measure 

(iii) Eligible hospital and CAH 

measure—(A) Measure. Subject to 

paragraph (d) of this section, more than 

10 percent of hospital discharge 

medication orders for permissible 

prescriptions (for new, changed, and 

refilled prescriptions) are queried for a 

drug formulary and transmitted 

electronically using Certified EHR 

Technology. 

(B) Exclusion in accordance with 

paragraph (c)(2) of this section. Any 

eligible hospital or CAH that does not 

have an internal pharmacy that can 

accept electronic prescriptions and is 

not located within 10 miles of any 

pharmacy that accepts electronic 

prescriptions at the start of their EHR 

reporting period. 

(C) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015. An eligible hospital or 

CAH previously scheduled to be in— 

(1) Stage 1 in 2015 may exclude the 

measure specified in paragraph 

(e)(4)(iii)(A) of this section for an EHR 

reporting period in 2015; or 

(2) Stage 2 in 2015 may exclude the 

measure specified in paragraph 

(e)(4)(iii)(A) of this section for an EHR 

reporting period in 2015 if they did not 

previously intend to select the Stage 2 

Electronic Prescribing Menu Objective 

for an EHR reporting period in 2015. 

(5) Summary of care—(i) Objective. 

The EP, eligible hospital or CAH who 

transitions a patient to another setting of 

care or provider of care or refers a 

patient to another provider of care 

provides a summary care record for each 

transition of care or referral. 

(ii) EP measure—(A) Measure. Subject 

to paragraph (d) of this section, the EP 

who transitions or refers his or her 

patient to another setting of care or 

provider of care must do the following: 

(1) Use CEHRT to create a summary 

of care record. 

(2) Electronically transmit such 

summary to a receiving provider for 

more than 10 percent of transitions of 

care and referrals. 

(B) Exclusion in accordance with 

paragraph (b)(2) of this section. Any EP 

who transfers a patient to another 

setting or refers a patient to another 

provider less than 100 times during the 

EHR reporting period. 

(C) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015. An EP previously 

scheduled to be in Stage 1 in 2015 may 

exclude the measure specified in 

paragraph (e)(5)(ii)(A) of this section for 

an EHR reporting period in 2015. 

(iii) Eligible hospital and CAH 

measure—(A) Measure. Subject to 

paragraph (d) of this section, the eligible 

hospital or CAH that transitions or 

refers its patient to another setting of 

care or provider of care must do the 

following: 

(1) Use CEHRT to create a summary 

of care record. 

(2) Electronically transmit such 

summary to a receiving provider for 

more than 10 percent of transitions of 

care and referrals. 

(B) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015. An eligible hospital or 

CAH previously scheduled to be in 

Stage 1 in 2015 may exclude the 

measure specified in paragraph 

(e)(5)(iii)(A) of this section for an EHR 

reporting period in 2015. 

(6) Patient specific education—(i) 

Objective. Use clinically relevant 

information from Certified EHR 

Technology to identify patient-specific 

education resources and provide those 

resources to the patient. 

(ii) EP measure—(A) Measure. 

Patient-specific education resources 

identified by Certified EHR Technology 

are provided to patients for more than 

10 percent of all unique patients with 

office visits seen by the EP during the 

EHR reporting period. 

(B) Exclusion in accordance with 

paragraph (b)(2) of this section. Any EP 

who has no office visits during the EHR 

reporting period. 

(C) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015. An EP previously 

scheduled to be in Stage 1 in 2015 may 

exclude the measure specified in 

paragraph (e)(6)(ii)(A) of this section for 

an EHR reporting period in 2015 if the 

EP did not previously intend to select 

the Stage 1 Patient-Specific Education 

Resources Menu Objective for an EHR 

reporting period in 2015. 

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(iii) Eligible hospital and CAH 

measure—(A) Measure. More than 10 

percent of all unique patients admitted 

to the eligible hospital’s or CAH’s 

inpatient or emergency department 

(POS 21 or 23) are provided patientspecific education resources identified 

by Certified EHR Technology. 

(B) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015. An eligible hospital or 

CAH previously scheduled to be in 

Stage 1 in 2015 may exclude the 

measure specified in paragraph 

(e)(6)(iii)(A) of this section for an EHR 

reporting period in 2015 if they did not 

previously intend to select the Stage 1 

Patient-Specific Education Resources 

Menu Objective for an EHR reporting 

period in 2015. 

(7) Medication reconciliation—(i) 

Objective. The EP, eligible hospital or 

CAH that receives a patient from 

another setting of care or provider of 

care or believes an encounter is relevant 

should perform medication 

reconciliation. 

(ii) EP measure—(A) Measure. Subject 

to paragraph (d) of this section, the EP 

performs medication reconciliation for 

more than 50 percent of transitions of 

care in which the patient is transitioned 

into the care of the EP. 

(B) Exclusion in accordance with 

paragraph (b)(2) of this section. Any EP 

who was not the recipient of any 

transitions of care during the EHR 

reporting period. 

(C) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015. An EP previously 

scheduled to be in Stage 1 in 2015 may 

exclude the measure specified in 

paragraph (e)(7)(ii)(A) of this section for 

an EHR reporting period in 2015 if they 

did not previously intend to select the 

Stage 1 Medication Reconciliation Menu 

Objective for an EHR reporting period in 

2015. 

(iii) Eligible hospital or CAH measure. 

An eligible hospital or CAH must meet 

the following measure, subject to 

paragraph (d) of this section: 

(A) Measure. Subject to paragraph (d) 

of this section, the eligible hospital or 

CAH performs medication 

reconciliation for more than 50 percent 

of transitions of care in which the 

patient is admitted to the eligible 

hospital’s or CAH’s inpatient or 

emergency department (POS 21 or 23). 

(B) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015. An eligible hospital or 

CAH previously scheduled to be in 

Stage 1 in 2015 may exclude the 

measure specified in paragraph 

(e)(7)(iii)(A) of this section for an EHR 

reporting period in 2015 if they did not 

previously intend to select the Stage 1 

Medication Reconciliation Menu 

Objective for an EHR reporting period in 

2015. 

(8) Patient electronic access—(i) EP 

objective. Provide patients the ability to 

view online, download, and transmit 

their health information within 4 

business days of the information being 

available to the EP. 

(A) EP measures. An EP must meet 

the following 2 measures: 

(1) More than 50 percent of all unique 

patients seen by the EP during the EHR 

reporting period are provided timely 

(within 4 business days after the 

information is available to the EP) 

online access to their health information 

subject to the EP’s discretion to 

withhold certain information. 

(2) At least 1 patient seen by the EP 

during the EHR reporting period (or 

their authorized representatives) views, 

downloads, or transmits his or her 

health information to a third party. 

(B) Exclusion in accordance with 

paragraph (b)(2) of this section. (1) Any 

EP who neither orders nor creates any 

of the information listed for inclusion as 

part of the measure in paragraph 

(e)(8)(ii)(A)(1) or (2) of this section, 

except for ‘‘Patient name’’ and 

‘‘Provider’s name and office contact 

information,’’ is excluded from both 

paragraphs (e)(8)(ii)(A)(1) and (2) of this 

section. 

(2) Any EP who conducts 50 percent 

or more of his or her patient encounters 

in a county that does not have 50 

percent or more of its housing units 

with 4Mbps broadband availability 

according to the latest information 

available from the Federal 

Communications Commission on the 

first day of the EHR reporting period is 

excluded from paragraph (e)(8)(ii)(A)(2) 

of this section. 

(C) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015. An EP previously 

scheduled to be in Stage 1 in 2015 may 

exclude the measure specified in 

paragraph (e)(8)(ii)(A)(2) of this section 

for an EHR reporting period in 2015. 

(ii) Eligible hospital and CAH 

objective. Provide patients the ability to 

view online, download, and transmit 

information within 36 hours of hospital 

discharge . 

(A) Eligible hospital and CAH 

measures. An eligible hospital or CAH 

must meet the following 2 measures: 

(1) More than 50 percent of all unique 

patients who are discharged from the 

inpatient or emergency department 

(POS 21 or 23) of an eligible hospital or 

CAH have their information available 

online within 36 hours of discharge. 

(2) At least 1 patient(or the patient’s 

authorized representative) who is 

discharged from the inpatient or 

emergency department (POS 21 or 23) of 

an eligible hospital or CAH views, 

downloads or transmits to a third party 

his or her information during the EHR 

reporting period. 

(B) Exclusion applicable under (c)(2) 

of this section. Any eligible hospital or 

CAH that is located in a county that 

does not have 50 percent or more of its 

housing units with 4Mbps broadband 

availability according to the latest 

information available from the FCC on 

the first day of the EHR reporting period 

is excluded from paragraph 

(e)(8)(iii)(A)(2) of this section. 

(C) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015. An eligible hospital or 

CAH previously scheduled to be in 

Stage 1 in 2015 may exclude the 

measure specified in paragraph 

(e)(8)(iii)(A)(2) of this section for an 

EHR reporting period in 2015. 

(9) Secure messaging—(i) EP 

objective. Use secure electronic 

messaging to communicate with 

patients on relevant health information. 

(ii) EP measure—(A) Measure. The 

capability for patients to send and 

receive a secure electronic message with 

the EP was fully enabled during the 

EHR reporting period. 

(B) Exclusion in accordance with 

paragraph (b)(2) of this section. An EP 

may exclude from the measure if he or 

she— 

(1) Has no office visits during the EHR 

reporting period; or 

(2) 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 

Federal Communications Commission 

on the first day of the EP’s EHR 

reporting period. 

(C) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015. An EP previously 

scheduled to be in Stage 1 in 2015 may 

exclude the measure specified in 

paragraph (e)(9)(ii)(A) of this section for 

an EHR reporting period in 2015. 

(10) Public Health and Clinical Data 

Registry reporting—(i) EP Public Health 

and Clinical Data Registry reporting— 

(A) Objective. The EP is in active 

engagement with a public health agency 

or clinical data registry 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. 

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(B) Measures. In order to meet the 

objective under paragraph (e)(10)(i)(A) 

of this section, an EP must choose from 

measures 1 through 5 (as specified in 

paragraphs (e)(10)(i)(B)(1) through 

(e)(10)(i)(B)(5) of this section) and must 

successfully attest to any combination of 

two measures. These measures may be 

met by any combination, including 

meeting measures specified in 

paragraph (e)(10)(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 (b)(2) 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 (e)(10)(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 his or her 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 his or her EHR 

reporting period. 

(iii) Operates in a jurisdiction where 

no immunization registry or 

immunization information system has 

declared readiness to receive 

immunization data from the EP 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 

(e)(10)(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 his or her 

jurisdiction. 

(ii) 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. 

(iii) 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. 

(3) An EP meeting one or more of the 

following criteria may be excluded from 

the case reporting measure at 

(e)(10)(i)(B)(3) if the EP: 

(i) Does not treat or diagnose any 

reportable diseases for which data is 

collected by his or her 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 his or her 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 

(e)(10)(i)(B)(4) of this section if the EP: 

(i) Does not diagnose or directly treat 

any disease or condition associated with 

a public health registry in his or her 

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 start 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 

(e)(10)(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 his or her 

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 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 start of the EHR reporting period. 

(D) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015. An EP previously 

scheduled to be in Stage 1 in 2015 may 

choose from measures 1 through 5 (as 

specified in paragraphs (e)(10)(i)(B)(1) 

through (e)(10)(i)(B)(5) of this section) 

and must successfully attest to any one 

measure in accordance with applicable 

law and practice for an EHR reporting 

period in 2015. 

(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 

or clinical data registry 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 (e)(10)(ii)(A) 

of this section, an eligible hospital or 

CAH must choose from measures 1 

through 6 (as described in paragraphs 

(e)(10)(ii)(B)(1) through (e)(10)(ii)(B)(6) 

of this section) and must successfully 

attest to any combination of three 

measures. These measures may be met 

by any combination, including meeting 

the measures specified in paragraph 

(e)(10)(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 

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20398 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 

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 (c)(2) of this section. (1) Any 

eligible hospital or CAH meeting one or 

more of the following criteria may be 

excluded from the immunization 

registry reporting measure specified in 

paragraph (e)(10)(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 from the eligible 

hospital or CAH 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 

(e)(10)(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 from 

eligible hospitals or CAHs 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 from eligible hospitals 

or CAHs at the start of the EHR 

reporting period. 

(3) An eligible hospital or CAH 

meeting one or more of the following 

criteria may be excluded from the case 

reporting measure specified in 

paragraph (e)(10)(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 its 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 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 (e)(10)(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 their 

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 start 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 (e)(10)(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 where 

no clinical data registry 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. 

(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)(10)(ii)(B)(6) of this section 

if the eligible hospital or CAH: 

(i) Does not perform or order 

laboratory tests that are reportable in the 

eligible hospital’s or CAH’s 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 from 

eligible hospitals or CAHs at the start of 

the EHR reporting period. 

(D) Alternate exclusions and 

specifications for an EHR reporting 

period in 2015. An eligible hospital or 

CAH previously scheduled to be in 

Stage 1 in 2015 may choose from 

measures 1 through 6 (as specified in 

paragraphs (e)(10)(ii)(B)(1) through 

(e)(10)(ii)(B)(6) of this section) and must 

successfully attest to any 2 measures. 

These measures may be met by any 

combination, including meeting the 

measures specified in paragraph 

(e)(10)(ii)(B)(4) or (5) of this section 

multiple times, in accordance with 

applicable law and practice. 

§ 495.7 [Redesginated as § 495.24] 

■ 6. Redesignate § 495.7 as § 495.24. 

§ 495.8 [Redesginated as § 495.40] 

■ 7. Redesignate § 495.8 as § 495.40. 

■ 8. Newly redesignated § 495.40 is 

amended by: 

■ A. In paragraph (a) introductory text 

by removing the cross-reference ‘‘under 

§ 495.6 or § 495.7’’ and adding in its 

place the cross-reference ‘‘under 

§ 495.20 or § 495.24’’. 

■ B. In paragraph (a)(1)(i)(B) by 

removing the cross-reference ‘‘under 

§ 495.6 or § 495.7’’ and adding in its 

place the cross-reference ‘‘under 

§ 495.20 or § 495.24’’. 

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

the cross-reference ‘‘in § 495.6 or § 495.7 

and § 495.8’’ and adding in its place the 

cross-reference ‘‘in § 495.20 or § 495.24 

and § 495.40’’. 

■ D. Revising paragraph (a)(2)(i)(B). 

■ E. In paragraph (a)(2)(i)(D) by 

removing the cross-reference ‘‘under 

§ 495.6(a)(4) or (h)(3)’’ and adding in its 

place the cross-reference ‘‘in 

§ 495.20(a)(4) or (h)(3)’’. 

■ F. Redesignating paragraph (a)(2)(i)(E) 

as paragraph (a)(2)(i)(F). 

■ G. Adding a new paragraph 

(a)(2)(i)(E). 

■ H. Revising newly redesignated 

paragraph (a)(2)(i)(F). 

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Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 20399 

■ I. Adding paragraph (a)(2)(i)(G). 

■ J. In paragraph (a)(2)(iv) by removing 

the cross-reference ‘‘in § 495.6 or § 495.7 

and § 495.8’’ and adding in its place the 

cross-reference ‘‘in § 495.20 or § 495.24 

and § 495.40’’. 

■ K. In paragraph (b)(1)(i)(B) by 

removing the cross-reference ‘‘under 

§ 495.6 or § 495.7’’ and adding in its 

place the cross-reference ‘‘under 

§ 495.20 or § 495.24’’. 

■ L. In paragraph (b)(1)(iii) by removing 

the cross-reference ‘‘in § 495.6 or § 495.7 

and § 495.8’’ and adding in its place the 

cross-reference ‘‘in § 495.20 or § 495.24 

and § 495.40’’. 

■ M. Revising paragraph (b)(2)(i)(B). 

■ N. In paragraph (b)(2)(i)(D) by 

removing the cross-reference ‘‘under 

§ 495.6(b)(4) or (i)(3)’’ and adding in its 

place the cross-reference ‘‘in 

§ 495.20(b)(4) or (h)(3)’’. 

■ O. Redesignating paragraph (b)(2)(i)(E) 

as paragraph (b)(2)(i)(F). 

■ P. Adding a new paragraph 

(b)(2)(i)(E). 

■ Q. Revising newly redesignated 

paragraph (b)(2)(i)(F). 

■ R. Adding paragraph (b)(2)(i)(G). 

The revisions and additions read as 

follows: 

§ 495.40 Demonstration of meaningful use 

criteria. 

(a) * * * 

(2) * * * 

(i) * * * 

(B) For calendar years before 2015, 

satisfied the required objectives and 

associated measures under § 495.20 for 

the EP’s stage of meaningful use. 

* * * * * 

(E) For CYs 2015 through 2017, 

satisfied the required objectives and 

associated measures under § 495.22(e) 

for meaningful use. 

(F) For CY 2017 only, an EP may 

satisfy either of the following objectives 

and measures for meaningful use: 

(1) Objectives and measures specified 

in § 495.22(e). 

(2) Objectives and measures specified 

in § 495.24(d) 

(G) For CY 2018 and subsequent 

years, satisfied the required objectives 

and associated measures under 

§ 495.24(d) for meaningful use. 

* * * * * 

(b) * * * 

(2) * * * 

(i) * * * 

(B) For fiscal years before 2015, 

satisfied the required objectives and 

associated measures under § 495.20 for 

the eligible hospital or CAH’s stage of 

meaningful use. 

* * * * * 

(E) For CYs 2015 through 2017, 

satisfied the required objectives and 

associated measures under § 495.22(e) 

for meaningful use. 

(F) For CY 2017 only, an eligible 

hospital or CAH may satisfy either of 

the following objectives and measures 

for meaningful use: 

(1) Objectives and measures specified 

at § 495.22(e); or 

(2) Objectives and measures specified 

at § 495.24(d). 

(G) For CY 2018 and subsequent 

years, satisfied the required objectives 

and associated measures under 

§ 495.24(h) for meaningful use. 

* * * * * 

§ 495.10 [Redesginated as § 495.60] 

■ 9. Redesignate § 495.10 as § 495.60. 

Dated: April 2, 2015. 

Andrew M. Slavitt, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: April 8, 2015. 

Sylvia M. Burwell, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2015–08514 Filed 4–10–15; 4:15 pm] 

BILLING CODE 4120–01–P 

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