This document is scheduled to be published in the

Federal Register on 03/30/2015 and available online at

http://federalregister.gov/a/2015-06685, and on FDsys.gov

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 495

[CMS-3310-P]

RIN 0938-AS26

Medicare and Medicaid Programs; Electronic Health Record Incentive 

Program-Stage 3

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

SUMMARY: This Stage 3 proposed rule would specify the meaningful use criteria that 

eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must 

meet in order to qualify for Medicare and Medicaid electronic health record (EHR) 

incentive payments and avoid downward payment adjustments under Medicare for 

Stage 3 of the EHR Incentive Programs. It would continue to encourage electronic 

submission of clinical quality measure (CQM) data for all providers where feasible in 

2017, propose to require the electronic submission of CQMs where feasible in 2018, and 

establish requirements to transition the program to a single stage for meaningful use. 

Finally, this Stage 3 proposed rule would also change the EHR reporting period so that all 

providers would report under a full calendar year timeline with a limited exception under 

the Medicaid EHR Incentive Program for providers demonstrating meaningful use for the 

first time. These changes together support our broader efforts to increase simplicity and 
CMS-3310-P 2

flexibility in the program while driving interoperability and a focus on patient outcomes 

in the meaningful use program.

DATES: To be assured consideration, comments must be received at one of the 

addresses provided below, no later than 5 p.m. on [insert date 60 days after date of 

publication in the Federal Register]. 

ADDRESSES: In commenting, please refer to file code CMS-3310-P. Because of staff 

and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

You may submit comments in one of four ways (please choose only one of the 

ways listed):

1. Electronically. You may submit electronic comments on this regulation to 

http://www.regulations.gov. Follow the "Submit a comment" instructions.

2. By regular mail. You may mail written comments to the following address 

ONLY:

Centers for Medicare & Medicaid Services,

Department of Health and Human Services,

Attention: CMS-3310-P,

P.O. Box 8013,

Baltimore, MD 21244-8013.

Please allow sufficient time for mailed comments to be received before the close 

of the comment period.

3. By express or overnight mail. You may send written comments to the 

following address ONLY:
CMS-3310-P 3

Centers for Medicare & Medicaid Services,

Department of Health and Human Services,

Attention: CMS-3310-P,

Mail Stop C4-26-05,

7500 Security Boulevard,

Baltimore, MD 21244-1850.

4. By hand or courier. Alternatively, you may deliver (by hand or courier) your 

written comments ONLY to the following addresses prior to the close of the comment 

period:

a. For delivery in Washington, DC--

Centers for Medicare & Medicaid Services,

Department of Health and Human Services,

Room 445-G, Hubert H. Humphrey Building,

200 Independence Avenue, SW.,

Washington, DC 20201

(Because access to the interior of the Hubert H. Humphrey Building is not readily 

available to persons without federal government identification, commenters are 

encouraged to leave their comments in the CMS drop slots located in the main lobby of 

the building. A stamp-in clock is available for persons wishing to retain a proof of filing 

by stamping in and retaining an extra copy of the comments being filed.) 
CMS-3310-P 4

b. For delivery in Baltimore, MD--

Centers for Medicare & Medicaid Services,

Department of Health and Human Services,

7500 Security Boulevard,

Baltimore, MD 21244-1850. 

If you intend to deliver your comments to the Baltimore address, call telephone 

number (410) 786-7195 in advance to schedule your arrival with one of our staff 

members.

Comments erroneously mailed to the addresses indicated as appropriate for hand 

or courier delivery may be delayed and received after the comment period.

For information on viewing public comments, see the beginning of the 

"SUPPLEMENTARY INFORMATION" section.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Holland, (410) 786-1309, Medicare EHR Incentive Program and Medicare 

payment adjustment 

Elisabeth Myers (CMS), (410) 786-4751, Medicare EHR Incentive Program 

Thomas Romano (CMS), (410) 786-0465, Medicaid EHR Incentive Program 

Ed Howard (CMS), (410) 786-6368, Medicare Advantage 

Deborah Krauss (CMS), (410) 786-5264, clinical quality measures

Alesia Hovatter (CMS), (410) 786-6861, clinical quality measures 

Elise Sweeney Anthony (ONC), (202) 475-2485, certification definition 
CMS-3310-P 5

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 website as soon as 

possible after they have been received: http://www.regulations.gov. Follow the search 

instructions on that website to view public comments. 

Comments received timely will also be available for public inspection as they are 

received, generally beginning approximately 3 weeks after publication of a document, at 

the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security 

Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 

8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 

1-800-743-3951.

Acronyms

API Application-program Interface

ARRA American Recovery and Reinvestment Act of 2009

AAC Average Allowable Cost (of certified EHR Technology)

ACO Accountable Care Organization 

AIU Adopt, Implement, Upgrade (certified EHR Technology)

CAH Critical Access Hospitals

CAHPS Consumer Assessment of Healthcare Providers and Systems

CCN CMS Certification Number
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CDC Centers for Disease Control

CEHRT Certified Electronic Health Record Technology

CFR Code of Federal Regulations

CHIP Children's Health Insurance Program

CHIPRA Children's Health Insurance Program Reauthorization Act of 2009

CMS Centers for Medicare and Medicaid Services

CPOE Computerized Physician Order Entry

CQM Clinical Quality Measure

CY Calendar Year

EHR Electronic Health Record

EP Eligible Professional

EPO Exclusive Provider Organization

FACA Federal Advisory Committee Act

FFP Federal Financial Participation 

FFY Federal Fiscal Year

FFS Fee-for-Service

FQHC Federally Qualified Health Center

FTE Full Time Equivalent

FY Fiscal Year

HEDIS Healthcare Effectiveness Data and Information Set

HHS Department of Health and Human Services

HIE Health Information Exchange
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HIT Health Information Technology

HITPC Health Information Technology Policy Committee 

HIPAA Health Insurance Portability and Accountability Act of 1996

HITECH Health Information Technology for Economic and Clinical Health Act

HMO Health Maintenance Organization 

HOS Health Outcomes Survey

HPSA Health Professional Shortage Area

HRSA Health Resources and Services Administration 

IAPD Implementation Advanced Planning Document

ICR Information Collection Requirement

IHS Indian Health Service

IPA Independent Practice Association 

IPPS Inpatient Prospective Payment System

IQR Inpatient Quality Reporting

IT Information Technology 

MA Medicare Advantage

MAC Medicare Administrative Contractor

MCO Managed Care Organization

MITA Medicaid Information Technology Architecture

MMIS Medicaid Management Information Systems

MSA Medical Savings Account

MU Meaningful Use
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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
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TIN Tax Identification Number

I. Executive Summary and Background

A. Executive Summary

1. Purpose of Regulatory Action

a. Need for Regulatory Action

In this proposed rule, we specify the policies that would be applicable for Stage 3 

of the Medicare and Medicaid EHR Incentive Programs. Under Stage 3, we are 

proposing a set of requirements that EPs, eligible hospitals, and CAHs must achieve in 

order to meet meaningful use, qualify for incentive payments under the Medicare and 

Medicaid EHR Incentive Programs, and avoid downward payment adjustments under 

Medicare. These Stage 3 requirements focus on the advanced use of certified EHR 

technology (CEHRT) to promote health information exchange and improved outcomes 

for patients. 

Stage 3 of meaningful use is expected to be the final stage and would incorporate 

portions of the prior stages into its requirements. In addition, following a proposed 

optional year in 2017, beginning in 2018 all providers would report on the same 

definition of meaningful use at the Stage 3 level regardless of their prior participation, 

moving all participants in the EHR Incentive Programs to a single stage of meaningful 

use in 2018. The incorporation of the requirements into one stage for all providers is 

intended to respond to stakeholder input regarding the complexity of the program, the 

success of certain measures which are part of the meaningful use program to date, and the 

need to set a long-term, sustainable foundation based on a consolidated set of key 
CMS-3310-P 10

advanced use objectives for the Medicare and Medicaid EHR Incentive Programs.

In addition, we propose changes to the EHR reporting period, timelines, and 

structure of the Medicare and Medicaid EHR Incentive Programs. We believe these 

changes would provide a flexible, clear framework to reduce provider burden, streamline 

reporting, and ensure future sustainability of the Medicare and Medicaid EHR Incentive 

Programs. These changes together lay a foundation for our broader efforts to support 

interoperability and quality initiatives focused on improving patient outcomes.

b. Legal Authority for the Regulatory Action

The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111–5) 

amended Titles XVIII and XIX of the Social Security Act (the Act) to authorize incentive 

payments to EPs, eligible hospitals, and CAHs, and Medicare Advantage (MA) 

organizations to promote the adoption and meaningful use of Certified Electronic Health 

Record Technology (CEHRT). Sections 1848(o), 1853(l) and (m), 1886(n), and 1814(l) 

of the Act provide the statutory basis for the Medicare incentive payments made to 

meaningful EHR users. These statutory provisions govern EPs, MA organizations (for 

certain qualifying EPs and hospitals that meaningfully use CEHRT), subsection (d) 

hospitals and critical access hospitals (CAHs), respectively. Sections 1848(a)(7), 1853(l) 

and (m), 1886(b)(3)(B), and 1814(l) of the Act also establish downward payment 

adjustments, beginning with calendar or fiscal year (FY) 2015, for EPs, MA 

organizations, subsection (d) hospitals, and CAHs that are not meaningful users of 

CEHRT for certain associated reporting periods. Sections 1903(a)(3)(F) and 1903(t) of 

the Act provide the statutory basis for Medicaid incentive payments. (There are no 
CMS-3310-P 11

payment adjustments under Medicaid). (For a more detailed explanation of the statutory 

basis for the EHR incentive payments, see the July 28, 2010 Stage 1 final rule titled, 

"Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Final 

Rule" (75 FR 44316 through 44317)).

2. Summary of Major Provisions

a. Meaningful Use in 2017 and Subsequent Years 

The Stage 1 final rule sets the foundation for the Medicare and Medicaid EHR 

Incentive Programs by establishing requirements for the electronic capture of clinical 

data, including providing patients with electronic copies of their health information. We 

outlined Stage 1 meaningful use criteria, and finalized core and menu objectives for EPs, 

eligible hospitals, and CAHs. (For a full discussion of Stage 1 of meaningful use, we 

refer readers to the Stage 1 final rule (75 FR 44313 through 44588).)

In the September 4, 2012 Stage 2 final rule (77 FR 53967 through 54162), we 

focused on the next step after the foundation of data capture in Stage 1, the exchange of 

that essential health data among health care providers and patients to improve care 

coordination. To this end, we maintained the same core-menu structure for several 

finalized Stage 1 core and menu objectives. We finalized that EPs must meet the 

measure for or qualify for an exclusion to 17 core objectives and 3 of 6 menu objectives. 

We finalized that eligible hospitals and CAHs must meet the measure or qualify for an 

exclusion to 16 core objectives and 3 of 6 menu objectives. We combined several 

Stage 1 measures included into Stage 2. With the experience providers gained from the 

Stage 1 final rule, we also increased functional objective measure thresholds in Stage 2 to 
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increase efficiency, effectiveness, and flexibility. We also finalized a set of clinical 

quality measures (CQMs) for all providers participating in any stage of the program to 

report to CMS beginning in 2014. (For a full discussion of the meaningful use objectives 

and measures, and the CQMs we finalized under Stage 2, we refer readers to the Stage 2 

final rule at 77 FR 53967 through 54162.) 

In this Stage 3 proposed rule, we build on the groundwork established in the 

Stage 1 and Stage 2 final rules, including continuing our goal started under Stage 2 to 

increase interoperable health data sharing among providers. In addition, this Stage 3 

proposed rule would also focus on the advanced use of EHR technology to promote 

improved patient outcomes and health information exchange. We also propose to 

continue improving program efficiency, effectiveness, and flexibility by making changes 

to the Medicare and Medicaid EHR Incentive Programs that simplify reporting 

requirements and reduce program complexity. These changes proposed respond to 

comments received in earlier rulemaking that expressed confusion and concerns 

regarding increased reporting burden related to the number of program requirements, the 

multiple stages of program participation, and the timing of EHR reporting periods. In 

order to address these stakeholder concerns, one significant change we propose for 

Stage 3 includes establishing a single set of objectives and measures (tailored to EP or 

eligible hospital/CAH) to meet the definition of meaningful use. This new, streamlined 

definition of meaningful use proposed for Stage 3 would be optional for any provider 

who chooses to attest to these objectives and measures for an EHR reporting period in 

2017; and would be required for all eligible providers - regardless of prior participation in 
CMS-3310-P 13

the EHR Incentive Program – for an EHR reporting period in 2018 and subsequent years. 

In addition to reducing program complexity, the Stage 3 proposed rule would 

further support efforts to align the EHR Incentive Programs with other CMS quality 

reporting programs that use certified EHR technology, such as the Hospital Inpatient 

Quality Reporting (IQR) and Physician Quality Reporting System (PQRS) programs, as 

well as continue alignment across care settings for providers demonstrating meaningful 

use. This alignment would both reduce provider burden associated with reporting on 

multiple CMS programs and enhance CMS operational efficiency. The Stage 3 proposed 

rule and ONC's 2015 Edition of Health Information Technology (Health IT) Certification 

Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health 

IT Certification Program Modifications (hereinafter referenced as the "2015 Edition 

proposed rule") published elsewhere in this edition of the Federal Register would also 

continue to support the privacy and security of patient health information within certified 

health IT. 

b. Meaningful Use Requirements, Objectives and Measures for 2017 and Subsequent 

Years

Under this Stage 3 proposed rule, with the exception of Medicaid providers in 

their first year of demonstrating meaningful use as detailed in section II.F.1. of this 

proposed rule, all providers (EPs, eligible hospitals, and CAHs) would report on a 

calendar year EHR reporting period beginning in calendar year 2017. This proposal 

builds on efforts to align the EHR reporting period with reporting periods for other 

quality reporting programs identified in the Stage 2 final rule (77 FR 53971 through 
CMS-3310-P 14

53975 and 54049 through 54051) and the FY 2015 Hospital Inpatient Prospective 

Payment Systems (IPPS) final rule (79 FR 49854 through 50449). In addition, all 

providers, other than Medicaid EPs and eligible hospitals demonstrating meaningful use 

for the first time, would be required to attest based on a full year of data for a single set of 

meaningful use objectives and measures to demonstrate Stage 3 of meaningful use, which 

is proposed as optional for an EHR reporting period in 2017 and mandatory for an EHR 

reporting period in 2018, and subsequent years for all providers participating in the 

Medicare and Medicaid EHR Incentive Programs. 

The methodology for the selection of the proposed Stage 3 objectives and 

measures for the Medicare and Medicaid EHR Incentive Programs included the 

following: 

 Review attestation data for Stages 1 and 2 of meaningful use.

 Conduct listening sessions and interviews with providers, EHR system 

developers, regional extension centers, and health care provider associations.

 Review recommendations from government agencies and advisory committees 

focused on health care improvement, such as the Health Information Technology (HIT) 

Policy Committee, the National Quality Forum (NQF), and the Centers for Disease 

Control (CDC). 

The information we gathered from these sources focused on analyzing measure 

performance, implementing discrete EHR functionalities and standards, and examining 

objectives and measures presenting the best opportunity to improve patient outcomes and 

enhance provider support. 
CMS-3310-P 15

Based on this analysis, we are proposing a set of 8 objectives with associated 

measures designed to do all of the following: 

 Align with national health care quality improvement efforts.

 Promote interoperability and health information exchange.

 Focus on the 3-part aim of reducing cost, improving access, and improving 

quality.

We intend to have this Stage 3 proposed rule be the last stage of the meaningful 

use framework, which leverages the structure identified in the Stage 1 and Stage 2 final 

rules, while simultaneously establishing a single set of objectives and measures designed 

to promote best practices and continued improvement in health outcomes in a sustainable 

manner. Measures in the Stage 1 and Stage 2 final rules that included paper-based 

workflows, chart abstraction, or other manual actions would be removed or transitioned 

to an electronic format utilizing EHR functionality for Stage 3. In addition, we are 

proposing the removal of "topped out" measures, or measures that are no longer useful in 

gauging performance, in order to reduce the reporting burden on providers for measures 

already achieving widespread adoption. 

c. Clinical Quality Measurement

EPs, eligible hospitals, and CAHs must report CQMs in order to qualify for 

incentive payments under the Medicare and Medicaid EHR Incentive Programs and avoid 

downward payment adjustments under Medicare. 

We are committed to continuing the electronic calculation and reporting of key 

clinical data through the use of CQMs. We are also focused on improving alignment of 
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reporting requirements for CMS programs using EHR technology, maintaining flexibility 

with reporting requirements while streamlining reporting mechanisms for providers, and 

increasing quality data integrity. 

This proposed rule addresses quality reporting alignment on several fronts. Our 

long-term vision seeks to have hospitals, clinicians, and other health care providers report 

through a single, aligned mechanism for multiple CMS programs. In the Stage 2 final 

rule, we outlined preliminary alignment options for quality reporting programs with the 

EHR Incentive Programs as the first step toward that vision (77 FR 54053). 

In order to facilitate continuous quality improvement, we need a method to allow 

changes to meaningful use CQMs and the associated reporting requirements on an 

ongoing basis. For other CMS quality reporting programs, changes occur through the 

annual Medicare payment rules, such as the Physician Fee Schedule (PFS) and the IPPS 

rules. Including CQMs in these annual rules would allow us to capture changes and 

updates annually. Therefore, we intend to further support alignment between the 

Medicare and Medicaid EHR Incentive Programs and other CMS quality reporting 

programs, such as PQRS and Hospital IQR, by including the reporting requirements for 

CQMs for providers demonstrating meaningful use in future rulemaking. We propose to 

continue encouraging CQM data submission through electronic submission for Medicare 

participants in 2017, and to require electronic submission of CQMs where feasible 

beginning in 2018 for Medicare providers demonstrating meaningful use. (We further 

discuss Medicaid CQM submission in section II.F.3. of this proposed rule.)

d. Payment Adjustments and Hardship Exceptions
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The statute requires Medicare payment adjustment beginning in 2015. For the 

Stage 3 proposed rule, we propose to maintain all payment adjustment provisions for all 

EPs, eligible hospitals, and CAHs finalized in the Stage 2 final rule (77 FR 54093 

through 54113 and 54115 through 54119) except for a change to the relationship between 

the EHR reporting period year and the payment adjustment year for CAHs. We are 

proposing a change to the timing of the EHR reporting period and related deadlines for 

attestations and hardship exceptions for CAHs in relation to the payment adjustment year, 

in order to accommodate a transition to EHR reporting for meaningful use on the 

calendar instead of the fiscal year timeline. The payment adjustment provisions being 

maintained in the Stage 3 proposed rule include the process we finalized in Stage 2 by 

which a prior EHR reporting period determines a payment adjustment. We also maintain 

the four categories of exceptions based on all of the following:

• The lack of availability of internet access or barriers to obtain IT infrastructure.

• A time-limited exception for newly practicing EPs or new hospitals that would

not otherwise be able to avoid payment adjustments.

• Unforeseen circumstances such as natural disasters that would be handled on a 

case-by-case basis.

• (EP only) exceptions due to a combination of clinical features limiting a 

provider's interaction with patients or, if the EP practices at multiple locations, lack of 

control over the availability of CEHRT at practice locations constituting 50 percent or 

more of their encounters. 

e. Modifications to the Medicaid EHR Incentive Program
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Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory basis for the 

Medicaid EHR Incentive Program. For this Stage 3 proposed rule, we propose that under 

the proposed changes to EHR reporting periods that would begin in 2017, Medicaid EPs 

and eligible hospitals demonstrating meaningful use for the first time in the Medicaid 

EHR Incentive Program would be required to attest for an EHR reporting period of any 

continuous 90-day period in the calendar year for purposes of receiving an incentive, as 

well as avoiding the payment adjustment under the Medicare Program. 

We are proposing to continue to allow states to set up a CQM submission process 

that Medicaid EPs and eligible hospitals may use to report on CQMs for 2017 and 

subsequent years. We also propose amendments to state reporting on providers who are 

participating in the Medicaid EHR Incentive Program as well as state reporting on 

implementation and oversight activities. 

f. Summary of Costs and Benefits

Upon finalization, the provisions in this proposed rule are anticipated to have an 

annual effect on the economy of $100 million or more, making it an economically 

significant rule under the Executive Order and a major rule under the Congressional 

Review Act. Accordingly, we have prepared a Regulatory Impact Analysis that to the 

best of our ability presents the costs and benefits of the final rule. The total federal cost 

of the Medicare and Medicaid EHR Incentive Programs between 2017 and 2020 is 

estimated to be $3.7 billion in transfers. In this proposed rule we do not estimate total 

costs and benefits to the provider industry, but rather provide a possible per EP and per 

eligible hospital outlay for implementation and maintenance. Nonetheless, we believe 
CMS-3310-P 19

there are substantial benefits that can be obtained by society (perhaps accruing to eligible 

hospitals and EPs), including cost reductions related to improvements in patient safety 

and patient outcomes and cost savings benefits through maximizing efficiencies in 

clinical and business processes facilitated by certified health IT. 

TABLE 1: ESTIMATED EHR INCENTIVE PAYMENTS AND BENEFITS 

IMPACTS ON THE MEDICARE AND MEDICAID PROGRAMS OF THE 

HITECH EHR INCENTIVE PROGRAM. (FISCAL YEAR) – (IN BILLIONS)

Fiscal 

Year

Medicare Eligible Medicaid Eligible

Hospitals Professionals Hospitals Professionals Total

2017 $1.6 $0.3 $0.4 $0.8 $3.1

2018 $0.0 -$0.2 $0.1 $0.5 $0.4

2019 $0.0 -$0.2 $0.0 $0.3 $0.1

2020 $0.0 -$0.1 $0.0 $0.2 $0.1
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B. Overview of the Regulatory History

The American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5)(ARRA) 

amended Titles XVIII and XIX of the Act to authorize incentive payments to EPs, 

eligible hospitals, and CAHs, and MA organizations to promote the adoption and 

meaningful use of CEHRT. In the July 28, 2010 Federal Register (75 FR 44313 through 

44588), we published a final rule ("Medicare and Medicaid Programs; Electronic Health 

Record Incentive Program", or "Stage 1 final rule") that specified the Stage 1 criteria EPs, 

eligible hospitals, and CAHs must meet in order to qualify for an incentive payment, 

calculation of the incentive payment amounts, and other program participation 

requirements. For a full explanation of the amendments made by ARRA, see the Stage 1 

final rule at 75 FR 44316. In that Stage 1 final rule, we also detailed that the Medicare 

and Medicaid EHR Incentive Program would consist of three different stages of 

meaningful use requirements. 

In the September 4, 2012 Federal Register (77 FR 53967 through 54162), 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. 
CMS-3310-P 21

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 
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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 
CMS-3310-P 23

Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to 

Part B for CY 2015; Final Rule (79 FR 67976 through 67978) (November 13, 2014 IFC). 

Under this November 13, 2014 IFC, we recognized a hardship exception for EPs and 

eligible hospitals for 2014 under the established category of extreme and uncontrollable 

circumstances in accordance with the Secretary's discretionary authority. To 

accommodate this hardship exception, we further extended the hardship application 

deadline for EPs and eligible hospitals to November 30 for 2014 only. We also amended 

the regulations to allow CMS to specify a later hardship application deadline for certain 

hardship categories for EPs, eligible hospitals, and CAHs. 

For Stages 1 and 2, CMS and ONC worked closely to ensure that the definition of 

meaningful use of CEHRT and the standards and certification criteria for CEHRT were 

coordinated. Current ONC regulations may be found at 45 CFR part 170. For this 

Stage 3 proposed rule, CMS and ONC will again work together to align our regulations.

We urge those interested in this Stage 3 proposed rule to also review the ONC 

2015 Edition proposed rule, which is published elsewhere in this Federal Register. 

Readers may also visit: http://www.cms.hhs.gov/EHRincentiveprograms and 

http://www.healthit.gov for more information on the efforts at the Department of Health 

and Human Services (HHS) to advance HIT initiatives. 
CMS-3310-P 24

II. Provisions of the Proposed Regulations

A. Meaningful Use Requirements, Objectives, and Measures for 2017 and Subsequent 

Years

1. Definitions across the Medicare Fee-for-Service, Medicare Advantage, and Medicaid 

Programs

a. Uniform Definitions

As discussed in both the Stage 1 and 2 final rules, we finalized several uniform 

definitions applicable for the Medicare FFS, Medicare Advantage, and Medicaid EHR 

Incentive Programs. We set forth these uniform definitions in part 495 subpart A of the 

regulations. We propose to maintain these definitions, unless stated otherwise in this 

proposed rule. (For further discussion of the uniform definitions finalized previously, we 

refer readers to the Stage 1 and Stage 2 final rules at 75 FR 44317 through 44321 and 

77 FR 53972). 

As discussed in sections II.A.1.c.(1). and (2). of this proposed rule, we are 

proposing a single set of criteria for meaningful use ("Stage 3") in order to eliminate the 

varying stages of the EHR Incentive Programs. We propose that this Stage 3 definition 

of meaningful use would be optional for providers in 2017 and mandatory for all 

providers beginning in 2018. To support Stage 3, we propose revising the uniform 

definitions under 42 CFR 495.4 for "EHR reporting period" and "EHR reporting period 

for a payment adjustment year," as explained later in this section. The proposed revisions 

to these uniform definitions include eliminating the current 90-day EHR reporting period 

for EPs, eligible hospitals, and CAHs demonstrating meaningful use for the first time, 
CMS-3310-P 25

and instead creating a single EHR reporting period aligned to the calendar year. The 

proposed removal of the 90-day EHR reporting period would not apply to Medicaid EPs 

and eligible hospitals demonstrating meaningful use for the first time. We believe 

eliminating the 90-day EHR reporting period for most providers would simplify 

reporting, by aligning providers on the same EHR reporting timeline across all settings. 

In addition, a single EHR reporting period on the calendar year would align the EHR 

Incentive Program with other CMS quality reporting programs using certified EHR 

technology such as the Hospital IQR Program and PQRS. Finally, a single EHR 

reporting period based on the calendar year allows for a single attestation period, thereby 

enabling the HHS systems to better capture data, conduct enhanced stress testing and 

issue resolution, and improve quality assurance of systems before each deployment. We 

detail the proposed revisions to each of the uniform definitions later in this section. 

b. Meaningful EHR User

In the Stage 3 proposed rule, we propose to modify the definition of "Meaningful 

EHR User" under 42 CFR 495.4 to include the Stage 3 objectives and measures defined 

at § 495.7. 

The definition of a "Meaningful EHR User" under the Act requires the use of 

certified electronic health record technology (CEHRT) (see, for example, section 

1848(o)(2) of the Act). We note that the term CEHRT is a defined term for the purpose

of meeting the objectives of the EHR Incentive Programs (defined at § 495.4). The term 

references ONC's certification criteria for a "Base EHR," other ONC certification criteria 

required in the EHR Incentive Programs and the definition of a "Meaningful EHR User." 
CMS-3310-P 26

References to CEHRT within this proposed rule are to certification criteria that are 

required for purposes of the EHR Incentive Programs. We recognize that CEHRT is just 

one form of health IT. For this reason, this proposed rule also includes references to 

"health IT" where appropriate to capture the broader category of technologies where

applicable.

c. Definition of Meaningful Use

(1) Considerations in Defining Meaningful Use

In sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act, the Congress identified 

the broad goal of expanding the use of EHRs through the concept of meaningful use. 

Section1903(t)(6)(C) of the Act also requires that Medicaid providers adopt, implement, 

upgrade or meaningfully use CEHRT if they are to receive incentives under Title XIX. 

CEHRT used in a meaningful way is one piece of the broader HIT infrastructure needed 

to reform the health care system and improve health care quality, efficiency, and patient 

safety. This vision of reforming the health care system and improving health care 

quality, efficiency, and patient safety should inform the definition of meaningful use.

As we explained in the Stage 1 and Stage 2 rules, we seek to balance the 

sometimes competing considerations of health system advancement (for example, 

improving health care quality, encouraging widespread EHR adoption, promoting 

innovation) and minimizing burdens on health care providers given the short timeframe 

available under the HITECH Act. 

Based on public and stakeholder input received during our Stage 1 rule, we laid 

out a phased approach to meaningful use. Such a phased approach encompasses 
CMS-3310-P 27

reasonable criteria for meaningful use based on currently available technology 

capabilities and provider practice experience, and builds up to a more robust definition of 

meaningful use as technology and capabilities evolve. The HITECH Act acknowledges 

the need for this balance by granting the Secretary the discretion to require more stringent 

measures of meaningful use over time. Ultimately, consistent with other provisions of 

law, meaningful use of CEHRT should result in health care that is patient centered, 

evidence-based, prevention-oriented, efficient, and equitable. 

As stated in the Stage 2 final rule (77 FR 53973), we anticipated the Stage 3 criteria 

for meaningful use would focus on promoting improvements in quality, efficiency, and 

safety leading to improved health outcomes. We also anticipated that Stage 3 would 

focus on clinical decision support for national high priority conditions; improving patient 

access to self-management tools; improving access to comprehensive patient data through 

robust, secure, patient-centered health information exchange; and improvements in 

population health.

For this Stage 3 proposed rule, we seek to streamline the criteria for meaningful 

use. We intend to do this by--

 Creating a single stage of meaningful use objectives and measures (Stage 3), 

which would be optional for all providers in 2017 and mandatory for all providers in 

2018; 

 Allowing providers flexible options for 2017; 

 Changing the EHR reporting period to a full calendar year for all providers; and

 Aligning with other CMS quality reporting programs using certified health IT
CMS-3310-P 28

such as PQRS and Hospital IQR for clinical quality measurement. 

(a) Meaningful Use Stages

Under the phased approach to meaningful use, we updated the criteria for 

meaningful use through staggered rulemaking, which covered Stages 1 and 2 of the EHR 

Incentive Program. For further explanation of the criteria we finalized under Stages 1 

and 2, including the recent final rule extending Stage 2, we refer readers to 75 FR 44314 

through 44588, 77 FR 53968 through 54162, and 79 FR 52910 through 52933. The 

current progression of the stages is outlined in Table 2. 

TABLE 2: STAGE OF MEANINGFUL USE CRITERIA

BY FIRST PAYMENT YEAR

First

Payment Year

Stage of Meaningful Use

2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

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

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

2013 1 1* 2 2 3 3 TBD TBD TBD

2014 1* 1 2 2 3 3 TBD TBD

2015 1 1 2 2 3 3 TBD

2016 1 1 2 2 3 3

2017 1 1 2 2 3

*3-month quarter EHR reporting period for Medicare and continuous 90-day EHR reporting period (or 3 months 

at Stage option) for Medicaid EPs. All providers in the first year in 2014 use any continuous 90-day EHR 

reporting period. 

In the Stage 2 final rule (77 FR 53974), we also stated that we would indicate in 

future rulemaking our intent for the potential development of stages or further criteria 

beyond Stage 3. In this proposed rule, we intend for Stage 3 to be the final stage in 

meaningful use and that no further stages would be developed. However, we understand 

that multiple technological and clinical care standard changes associated with EHR 

technology may result in the need to consider changes to the objectives and measures of 

meaningful use under the EHR Incentive Programs. Accordingly, we note that, as 

circumstances warrant, we would consider addressing such changes in future rulemaking. 
CMS-3310-P 29

As shown in Table 2, providers in any given year may be participating in 1 of 3 

different stages of the EHR Incentive Programs in addition to other CMS quality 

reporting programs using certified health IT such as PQRS and Hospital IQR. Through 

listening sessions, correspondence, and public comment forums, providers expressed 

frustration regarding the competing reporting requirements of multiple CMS programs, 

and the overall challenge of planning and reporting on the complex and numerous 

meaningful use requirements, including the need to manage changing processes, 

workflows, and reporting systems. In addition, group practices with EPs in different 

stages of meaningful use have to simultaneously support multiple stages of the program 

in order to demonstrate meaningful use for each EP. Meanwhile, if the current 3-stage 

framework continues, HHS and state systems would be required to support all 3 stages of 

the EHR Incentive Programs in perpetuity with extensive implementation of complex 

processes to accept submissions, analyze data, and coordinate systems. 

Providers have expressed ongoing concern that the EHR Incentive Programs are 

complicated, not focused on clinical reality and workflow, and stifling to innovation in 

health IT development. Specifically, providers have expressed concerns about the 

number of Stage 1 and 2 objectives and measures becoming obsolete or lacking any link

to improving outcomes. In addition, providers have expressed concern that continued 

focus on Stage 1 measures impedes current and potential future innovation in advanced 

utilization of health information technology. Providers worry that Stage 3 of meaningful 

use would exacerbate these existing concerns. 
CMS-3310-P 30

The certified EHR technology requirements within the EHR Incentive Programs 

and included in ONC's Health IT Certification Program have resulted in considerable 

increases in certified EHR technology adoption among providers and are paving the way 

for more comprehensive, patient-centered care across the care continuum. We recognize 

that while these advancements have been beneficial there are concerns, as stated 

previously, that require careful examination to ensure the sustainability and efficacy of 

the program going forward—as HHS moves to further encourage new uses of health IT 

and support the developing health IT infrastructure beyond the strides already made. 

Therefore, we seek to set a new foundation for this evolving program by proposing a 

number of changes to meaningful use. First, we propose a definition of meaningful use 

that would apply beginning in 2017. This definition of meaningful use, although referred 

to as "Stage 3", would be the only definition for the Medicare and Medicaid EHR 

Incentive Programs, and would incorporate certain requirements and aspects of Stages 1 

and 2. Beginning with 2018, we propose to require all EPs, eligible hospitals, and CAHs, 

regardless of their prior participation in the EHR Incentive Program, to satisfy the 

requirements, objectives, and measures of Stage 3. However, for 2017, we propose that 

Stage 3 would be optional for providers. This option would allow for a provider to move 

on to Stage 3 in 2017 or remain at Stage 2, or for some providers to remain at Stage 1, 

depending on their participation timeline. For example, under this proposal, a provider in 

Stage 2 in 2016 could choose to remain in Stage 2 in 2017 or progress to Stage 3. In 

contrast to our rulemaking in 2014 to accommodate the use of multiple Editions to meet 

the definitions of CEHRT during the EHR reporting periods in that year, this policy is 
CMS-3310-P 31

based on the provider selection of the objectives and measures for their demonstration of 

meaningful use in 2017. Both the EHR technology certified to the 2014 Edition and the 

EHR technology certified to the 2015 Edition will support attestations for Stage 1 or 

Stage 2 in 2017. In addition, the development and certification process for EHR 

technology products is not dependent on this selection by individual providers. 

Therefore, we do not expect that this policy would affect the availability of EHR 

technology certified to the 2015 Edition in 2017 or the ability of an individual provider to 

implement EHR technology certified to the 2015 Edition during the year regardless of 

which stage they choose for their EHR reporting period in 2017. Therefore, we are 

proposing in section II.A.2.b. that all providers would be required to use EHR technology 

certified to the 2015 Edition for a full calendar year for the EHR reporting period in 

2018. The revised timeline based on these proposals is outlined in Table 3. 

TABLE 3: STAGE OF MEANINGFUL USE CRITERIA 

BY FIRST YEAR

First

Year as a 

Meaningful EHR 

User

Stage of Meaningful Use

2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

2021 

and 

future 

years

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

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

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

2014 1 1 2 2 or 3 3 3 3 3

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

2016 1 1, 2 or 3 3 3 3 3

2017 1, 2 or 3 3 3 3 3

2018 and future years 3 3 3 3

*Please note, a provider scheduled to participate in Stage 2 in 2014, who instead elected to demonstrate stage 

1 because of delays in availability of EHR technology certified to the 2014 Edition, is still considered a stage 2 

provider in 2014 despite the alternate demonstration of meaningful use. In 2015, all such providers are considered to be 

participating in their second year of Stage 2 of meaningful use. 
CMS-3310-P 32

Please note that the Medicare EHR Incentive Program and the Medicaid EHR 

Incentive Program have different rules regarding the number of payment years available, 

the last year for which incentive payments may be received, and the last year to initiate 

the program and receive an incentive payment. Medicaid EPs and eligible hospitals can 

receive a Medicaid EHR incentive payment for "adopting, implementing, and upgrading"

(AIU) to Certified EHR Technology for their first payment year, which is not reflected in 

Table 3. The applicable payment years and the incentive payments available for each 

program are discussed in the Stage 1 final rule (75 FR 44318 through 44320). Although 

Table 3 outlines a provider's progression through the stages of meaningful use, it does not 

necessarily reflect the relation to incentive payments in the Medicare or Medicaid EHR 

Incentive Programs. We note that some providers may not ever qualify to receive an 

incentive payment depending on, among other factors, when and whether they 

successfully demonstrate meaningful use in the EHR Incentive Programs. We intend for 

the timeline in Table 3 to also apply to those EPs, eligible hospitals, and CAHs that never 

receive an incentive payment under the EHR Incentive Programs.

We are further proposing that Stage 3 would adopt a simplified reporting structure 

on a focused set of objectives and associated measures to replace all criteria under 

Stages 1 and 2. Specifically, we are proposing criteria for meaningful use for EPs, 

eligible hospitals, and CAHs (optional in 2017 and mandatory beginning in 2018), 

regardless of a provider's prior participation in the Medicare and Medicaid EHR 

Incentive Programs, as described in detail in section II.A.1.c. of this proposed rule. We 

believe that a single set of objectives would reduce provider burden and allow for greater 
CMS-3310-P 33

focus on improving outcomes, enhancing interoperability, and increasing patient 

engagement. In addition, with all providers participating at the same level, the impact of 

the scale of participation helps to support growth in health information exchange and 

patient engagement infrastructure, as more providers participate the ease of participation 

increases. Finally, the associated measures proposed for Stage 3 in this proposed rule 

would use advanced EHR functionality and IT-based processes. The requirements, 

objectives, and measures are outlined further in sections II.A.1.c.(2). of this proposed 

rule. In order to maintain clarity in relation to the various rules and stages, provisions 

outlined in the Stage 1 or Stage 2 final rules, and proposals under this Stage 3 proposed 

rule, we will maintain the "Stage" designation in order to indicate the rule that contains 

the provision. The requirements, objectives, and measures proposed as part of this 

proposed definition of meaningful use would be referred to as "Stage 3". 

We welcome public comment on these proposals. 

(b) EHR Reporting Period

In the Stage 1 and Stage 2 final rules, we established that the EHR reporting 

period for eligible hospitals and CAHs is based on the federal fiscal year (October 1 

through September 30). This fiscal year EHR reporting period originally was designed to 

support coordination between program implementation and CMS payment systems 

following the development of the EHR Incentive Programs in 2010 to allow for efficient 

payment of incentives for eligible hospitals and CAHs. However, as the EHR Incentive 

Program evolved, we found the fiscal year EHR reporting period resulted in varying 

reporting timelines between provider types (for example, the EHR reporting period for 
CMS-3310-P 34

EPs is based on the calendar year) and a shortened timeline for system developers to meet 

hospital and CAH technology requirements. Enhanced coordination between CMS 

programs and other system implementation changes have subsequently made it 

unnecessary to maintain a reporting timeframe for eligible hospitals and CAHs based on 

the federal fiscal year. Therefore, we are proposing changes to the EHR reporting period 

beginning with the EHR reporting period in 2017 in order to do all of the following:

 Simplify reporting for providers, especially groups and diverse systems.

 Support further alignment of CMS quality reporting programs using certified 

health IT such as Hospital IQR and PQRS.

 Simplify HHS system requirements for data capture.

 Provide for greater flexibility, stress testing, and Quality Assurance (QA) of 

systems before deployment. 

In the FY 2015 IPPS final rule (79 FR 49853 through 50449), we aligned the 

reporting and submission timelines for CQMs for the Medicare EHR Incentive Programs 

for eligible hospitals and CAHs with the reporting and submission timelines for the 

Hospital IQR Program on a calendar year basis. This was designed to allow for better 

alignment between these programs in light of the directive in section 1886(n)(3)(B)(iii) of 

the Act to avoid redundant or duplicative reporting. Calendar year reporting on quality 

data for hospitals allows for greater efficiency in measure development, the electronic 

specification of measures, and the update and deployment of measure logic and value sets 

for electronic clinical quality measures. The FY 2014 IPPS final rule (78 FR 50904) 

clarified that eligible hospitals and CAHs demonstrating meaningful use for the first time 
CMS-3310-P 35

in FY 2014 and reporting on CQMs electronically must report on a 3-month quarter in 

FY 2014, rather than on a continuous 90-day period. Such changes not only better align

program reporting but also allow for better data integrity as previously discussed in the 

Stage 2 final rule (77 FR 53974 through 53975) and further discussed in section II.B.1.b.

of this proposed rule. 

(i) Calendar Year Reporting

We are proposing to change the definitions of "EHR reporting period" and "EHR 

reporting period for a payment adjustment year" under § 495.4 for EPs, eligible hospitals, 

and CAHs such that the EHR reporting period would be one full calendar year, with a 

limited exception under the Medicaid EHR Incentive Program for providers 

demonstrating meaningful use for the first time as discussed later in this section and in 

section II.A.2.b. of this proposed rule. This would allow for the full alignment of the 

EHR reporting timeline for the meaningful use objectives and associated measures and 

the CQMs, and align the timing of reporting by EPs, eligible hospitals, and CAHs. We 

propose this change would apply beginning in CY 2017. For example, for the incentive 

payments for the 2017 payment year, the EHR reporting period for EPs, eligible 

hospitals, and CAHs would be the full 2017 calendar year. We note that the incentive 

payments under Medicare FFS and Medicare Advantage (MA) (sections 1848(o), 

1886(n), 1814(l)(3), 1853(l) and (m) of the Act) will end before 2017. However, under 

this proposed change, EPs and eligible hospitals that seek to qualify for an incentive 

payment under Medicaid would have a full calendar year EHR reporting period if they 

are not demonstrating meaningful use for the first time. For the payment adjustments 
CMS-3310-P 36

under Medicare, we discuss the timing of the EHR reporting period in relation to the 

payment adjustment year in section II.D.2. of this proposed rule. 

This proposal would mean that eligible hospitals and CAHs would have a 

reporting gap for the objectives and measures of meaningful use consisting of the 

3-month quarter from October 1, 2016 through December 31, 2016. Depending on future 

rulemaking, eligible hospitals and CAHs may still be required to report on CQMs over 

this time. The next EHR reporting period for eligible hospitals and CAHs to collect data 

on the objectives and measures of meaningful use would then begin on January 1, 2017 

and end on December 31, 2017. Eligible hospitals and CAHs would then report on a full 

calendar year basis from that point forward. 

(ii) Eliminate 90-day EHR Reporting Period

We are further proposing to eliminate the 90-day EHR reporting period for new 

meaningful EHR users beginning in 2017, with a limited exception for Medicaid EPs and 

eligible hospitals demonstrating meaningful use for the first time. This would allow for a 

single EHR reporting period of a full calendar year for all providers across all settings. 

Specifically, we propose to eliminate the EHR reporting period of any continuous 

90 days for EPs, eligible hospitals, and CAHs that are demonstrating meaningful use for 

the first time. Those providers instead would have an EHR reporting period of a full 

calendar year, as described previously. However, as discussed in section II.A.2.b. of this 

proposed rule, we propose to maintain the 90-day EHR reporting period for a provider's 

first payment year based on meaningful use for EPs and eligible hospitals participating in 

the Medicaid EHR Incentive Program. We propose corresponding revisions to the 
CMS-3310-P 37

definitions of "EHR reporting period" and "EHR reporting period for a payment 

adjustment year" under § 495.4. We propose these changes would apply beginning in 

CY 2017. 

As stated previously, all providers would attest based on a single EHR reporting 

period consisting of one full calendar year for the applicable objectives and measures of 

meaningful use in 2017 and subsequent years. These providers would submit their data 

in the 2 months following the close of the EHR reporting period. For further information 

on the submission methods, see section II.D.9.b. of this proposed rule. 

We welcome public comment on these proposals. 

(iii) State Flexibility for Stage 3 of Meaningful Use 

Consistent with our approach under both Stage 1 and 2, we propose to continue to 

offer states flexibility under the Medicaid EHR Incentive Program in Stage 3 by adding a 

new provision at § 495.316(d)(2)(iii) subject to the same conditions and standards as the 

Stage 2 flexibility policy. Under Stage 3, state flexibility would apply only with respect 

to the public health and clinical data registry reporting objective outlined under section 

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

For Stage 3 of meaningful use, we would continue to allow states to specify the 

means of transmission of the data and otherwise change the public health agency 

reporting objective as long as it does not require functionality greater than what is 

required for Stage 3 and included in the 2015 Edition proposed rule elsewhere in this 

issue of the Federal Register.

We welcome comment on this proposal.
CMS-3310-P 38

(2) Criteria for Meaningful Use Stage 3

In the Stage 1 and Stage 2 final rules, meaningful use included the concept of a 

core and a menu set of objectives. Each objective had associated measures that a 

provider needed to meet as part of demonstrating meaningful use of CEHRT. In Stage 2 

of meaningful use, we also combined some of the objectives of Stage 1 and incorporated

them into objectives for Stage 2. For example, we combined the objectives of 

maintaining an up-to-date problem list, active medication list, and active medication 

allergy list with the objective of providing a summary of care record for each transition of 

care or referral through required fields in the summary of care document (77 FR 53990

through 53991 and 77 FR 54013 through 54016). We did this to allow for the more 

advanced use of EHR technology functions to support clinical processes, and to eliminate 

the need for providers to individually report on measures that were often already 

incorporated in workflows and for which many providers were already meeting the 

threshold (known as "topping out"). In the Stage 2 final rule (77 FR 53973), we signaled 

that the Stage 2 core and menu objectives would all be included in the Stage 3 proposal 

for meaningful use. 

Since the publication of the Stage 2 final rule, we have reviewed meaningful use 

performance from both a qualitative and quantitative perspective including analyzing

performance rates, reviewing CEHRT functionalities and standards, and considering

information gained by engaging with providers through listening sessions, 

correspondence, and open forums like the HIT Policy Committee. The data support a 

number of key points for consideration: 
CMS-3310-P 39

 Providers are performing higher than the thresholds for some of the meaningful 

use measures using some EHR functionalities that—prior to the Stage 1 and Stage 2 final 

rules—were not common place (such as the maintenance of problem lists).

 Providers in different specialties and settings implemented CEHRT and met 

objectives in different ways.

 Providers express support for reducing the reporting burden on measures that

have "topped out."

 Providers expressed support for advanced functionality that would offer value 

to providers and patients.

 Providers expressed support for flexibility regarding how objectives are 

implemented in their practice settings.

 Providers in health systems and large group practices expressed frustration 

about the reporting burden of having to compile multiple reports spanning multiple stages 

and objectives.

Since the EHR Incentive Programs began in 2011, stakeholder associations and 

providers have requested that we consider changes to the number of objectives and 

measures that providers must meet to demonstrate meaningful use of certified EHR 

technology under the EHR Incentive Programs. These recommendations also extended to 

considerations for the structure of Stage 3 of meaningful use. Many of these 

recommendations include allowing a provider to fail any two objectives (in effect making 

all objectives "menu" objectives) and still meet meaningful use, or to allow providers to 

receive an incentive payment or avoid a downward payment adjustment based on varied 
CMS-3310-P 40

percentages of performance, and removing all measure thresholds. We have reviewed 

these recommendations and have declined to follow this course for a number of reasons. 

First, the statute specifically requires the Secretary to seek to improve the use of 

EHR and health care quality over time by requiring more stringent measures of 

meaningful use (see, for example, section 1848(o)(2)(A)(iii) of the Act). This is one 

reason why we established stages of meaningful use to move providers along a 

progression from adoption to advanced use of certified EHR technology. Therefore, we 

intend to continue to use measure thresholds that may increase over time, and to 

incorporate advanced use functions of certified EHR technology into meaningful use 

objectives and measures. 

Second, there are certain objectives and measures which capture policies 

specifically required by the statute as core goals of meaningful use of certified EHR 

technology, such as electronic prescribing for EPs, health information exchange, and 

clinical quality measurement (see sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act). 

Specific to the health information exchange, the statute requires certified EHR 

technology connected in a manner that provides for the electronic exchange of health 

information to improve the quality of health care, such as promoting care coordination.

Further, the statute requires that the certified EHR technology which providers 

must use shall be a "qualified EHR" as defined in section 3000(13) of the Public Health 

Service Act as an electronic record of health-related information on an individual that 

includes patient demographic and clinical health information, such as medical history and 

problem lists; and has the capacity to-- 
CMS-3310-P 41

 Provide clinical decision support;

 Support physician order entry; 

 Capture and query information relevant to health care quality; and 

 Exchange electronic health information with, and integrate such information 

from, other sources (see section 1848(o)(4) of the Act).

The objectives that address these requirements are integral to the foundational 

goals of the program, which would be undermined if providers were allowed to fail to 

meet these objectives and still be considered meaningful EHR users. For these reasons, 

we intend to continue to require providers to meet the objectives and measures of 

meaningful use as required for the program, rather than allowing providers to fail any two

objectives of their choice or making all objectives menu objectives. 

Finally, while we understand providers are seeking to reduce the overall burden of 

reporting, we do not believe these recommendations accomplish that goal. Adding all 

objectives and measures to the menu set and allowing for varying degrees of participation 

may add complexity for the individual provider seeking to determine how they can meet 

the requirements and demonstrate meaningful use of certified EHR technology. We 

instead are proposing (as discussed in sections II.A.1. and II.B. of this proposed rule) to 

reduce provider burden and simplify the program by aligning reporting periods and CQM 

reporting. In addition, the statute provides that in selecting measures for the EHR 

Incentive Program, the Secretary shall seek to avoid redundant or duplicative reporting 

otherwise required, including reporting under the PQRS and Hospital IQR Program (see 

sections 1848(o)(2)(B)(iii) and 1886(n)(3)(B)(iii) of the Act). Although the statute refers 
CMS-3310-P 42

to redundant or duplicative reporting in the context of other CMS quality reporting 

programs, we believe it is also useful and appropriate to consider whether there are 

redundant or duplicative aspects of the objectives and measures of Stages 1 and 2 of 

meaningful use as we develop policies for Stage 3. 

To that end, we have analyzed the objectives and measures of meaningful use in 

Stage 1 and Stage 2 of the program to determine where measures are redundant, 

duplicative, or have "topped out." "Topped out" is the term used to describe measures 

that have achieved widespread adoption at a high rate of performance and no longer 

represent a basis upon which provider performance may be differentiated. We 

considered redundant objectives and measures to include those where a viable health 

IT-based solution may replace paper-based actions, such as the Stage 2 Clinical Summary 

objective (77 FR 54001 and 54002). We considered duplicative objectives and measures 

to include those where some aspect is also captured in the course of meeting another 

objective or measure, such as recording vital signs which is also required as part of the 

summary of care document under the Stage 2 Summary of Care objective (77 FR 54013

through 54021). Finally, measures which have "topped out" do not provide a meaningful 

gain in the effort to improve the use of EHR and health care quality over time by 

requiring more stringent measures of meaningful use as directed in the statute (see 

section 1848(o)(2)(A)(iii) of the Act). For further discussion of "topped out" measures, 

we direct readers to section II.A.2.a. of this proposed rule.

Therefore, our proposals for Stage 3 would continue the precedent of focusing on 

the advanced use of certified EHR technology. They would reduce the reporting burden;
CMS-3310-P 43

eliminate measures that are now redundant, duplicative, and "topped out"; create a single 

set of objectives for all providers with limited variation between EPs, eligible hospitals,

and CAHs as necessary; and provide flexibility within the objectives to allow providers 

to focus on implementations that support their practice.

(a) Topped Out Objectives and Measures

In other contexts and CMS programs, CQMs are regularly evaluated to determine 

whether they have "topped out," which means generally that measure performance among

providers is so high and unvarying that meaningful distinctions and improvements in 

performance can no longer be made. Examples of this type of evaluation are found in the 

Hospital Inpatient Quality Reporting (IQR) program, the Hospital-Value Based 

Purchasing (HVBP) program, the End-Stage Renal Disease (ESRD) Quality Initiative, 

and within the National Quality Forum (NQF) endorsement and maintenance process for 

CQMs. We believe that quality measures, once ''topped-out,'' represent care standards 

that have been widely adopted. We believe such measures should be considered for 

removal from program reporting because their associated reporting burden may outweigh 

the value of the quality information they provide and because, in some cases, the 

inclusion of these measures may impact the ability to differentiate among provider 

performance as a whole for programs which use baseline and benchmarking based on 

measure performance scores. Therefore, measures are regularly subject to an evaluation 

process to identify their continued efficacy. This evaluation process is used to determine 

whether a measure is "topped out" and, if so, whether that measure should be removed 

from program reporting requirements. We note that both the identification and the 
CMS-3310-P 44

determination of a measure are part of the process as a measure may be identified as 

topped out, but still be determined useful as a measure for a specific program because of 

other factors that merit continued use of the measure. 

While the EHR Incentive Program does not use a benchmarking system to rate the 

overall and relative performance of providers as part of the definitions of meaningful use;

we are proposing to adopt an approach to evaluate whether objectives and measures have 

become "topped out" and, if so, whether a particular objective or measure should be 

considered for removal from reporting requirements. We propose to apply the following 

two criteria, which are similar to the criteria used in the Hospital IQR and HVBP 

Programs (79 FR 50203): 1 –statistically indistinguishable performance at the 75th and 

99th percentile, and 2 – performance distribution curves at the 25th, 50th, and 75th

percentiles as compared to the required measure threshold. 

An example of a current Stage 1 objective which would be considered "topped 

out" under this approach is the objective to record demographics (75 FR 44340 through 

44343). For the record demographics objective, we reviewed performance data 

submitted by providers through attestation and determined that across all years of 

participation, the 75th percentile is performing at 99.8 percent with the 99th percentile 

performing at 100 percent. In addition, the 25th, 50th, and 75th percentiles are all 

performing with minimal variance and significantly higher than the measure threshold of 

50 percent, with performance rates at 97 percent, 99 percent, and 100 percent respectively

for eligible hospitals and 92 percent, 98 percent and 100 percent respectively for EPs in 
CMS-3310-P 45

Stage 1.

1

For more information on the performance data, please see the EHR Incentive 

Programs Objective and Measure Performance Report by Percentile available at

http://www.cms.gov/Regulations-andGuidance/Legislation/EHRIncentivePrograms/DataAndReports.html. We further note 

that this particular objective may also be considered duplicative as further discussed in 

section II.A.2.c. of this proposed rule, as the functionality which supports the objective 

within the EHR is also used in other objectives such as the objective to provide

patient-specific education resources (77 FR 54011 through 54012) and the Stage 2 

summary of care objective (77 FR 54013 through 54021). Therefore, this is an example 

of an objective that we determined is topped out and may no longer provide value as an 

independent objective in the program. 

We welcome public comments on our proposed approach for topped out 

objectives and measures.

(b) Electronic Versus Paper-based Objectives and Measures

In Stages 1 and 2, we require or allow providers the option to include paper-based 

formats for certain objectives and measures. For these objectives and measures, 

providers would print, fax, mail, or otherwise produce a paper document and manually 

count these actions to include in the measure calculation. Examples of these include: the 

provision of a non-electronic summary of care document for a transition or referral to 

meet the measure at § 495.6(j)(14)(i) for EPs and for eligible hospitals and CAHs 

at§ 495.6(l)(11)(i): "The [provider] who transitions or refers their patient to another 

 

1 Data may be found on the CMS website data and program reports page: https://www.cms.gov/Regulations-andGuidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
CMS-3310-P 46

setting of care or provider of care provides a summary of care record for more than 

50 percent of transitions of care and referrals;" and the provision of paper-based patient 

education materials measure for at § 495.6(j)(12)(i) for EPs and § 495.6(l)(9)(i)

requiring: "Patient-specific education resources identified by Certified EHR Technology 

are provided to patients for more than 10 percent of all unique patients with office visits 

seen by the EP [or discharged from the eligible hospital or CAH] during the EHR 

reporting period." Each of these measures may be met using a non-electronic format or

action, and we propose to discontinue this policy for Stage 3. We recognize the strides 

that providers have made in the use of CEHRT and as we move forward in MU, it is 

appropriate to remove the earlier iterations of objectives and measures that were designed 

to support beginning EHR use and instead focus on objectives that are based solely on 

electronic use of data. This does not imply that we do not support the continued use of 

paper-based materials in a practice setting. Some patients may prefer to receive a paper 

version of their clinical summary or may want to receive education items or reminders on 

paper or some other method that is not electronic. We strongly recommend that 

providers continue to provide patients with visit summaries, patient health information, 

and preventative care recommendations in the format that is most relevant for each 

individual patient and easiest for that patient to access. In some cases, this may include 

the continued use of non-IT-based resources. We are simply proposing that paper-based 

formats would not be required or allowed for the purposes of the objectives and measures 

for Stage 3 of meaningful use. We welcome public comments on this proposal.

(c) Advanced EHR Functions
CMS-3310-P 47

As discussed in section II.A.1.c.(2).(a). of this proposed rule, we are proposing to 

simplify requirements for meaningful use through an analysis of existing objectives and 

measures for Stages 1 and 2 to determine if they are redundant, duplicative, or "topped 

out". We note that some of the objectives and measures which meet these criteria involve 

EHR functions that are required by the statutory definition of "certified EHR technology"

(see section 1848(o)(4) of the Act, which references the definition of "qualified EHR" in 

section 3000(13) of the Public Health Service Act) which a provider must use to 

demonstrate meaningful use. The objectives and measures proposed for Stage 3 would 

include uses of these functions in a more advanced form. For example, patient 

demographic information is included in an electronic summary of care document called a 

consolidated clinical document architecture (CCDA) provided during a transition of care 

in the Stage 2 Summary of Care objective and measures (77 FR 54013 through 54021), 

which represents a more advanced use of the EHR function than in the Stage 1 and 2 

objective to record patient demographic information (77 FR 53991 through 53993).

We adopted a multi-part approach to identify the objectives and measures which 

would be proposed for providers to demonstrate meaningful use for Stage 3. This 

methodology included the analysis mentioned previously of existing Stage 1 and 2 

objectives and measures, and provider performance; a review and consideration of the 

HIT Policy Committee recommendations (which are publically available for review at: 

http://www.healthit.gov/facas/health-it-policy-committee/health-it-policy-committeerecommendations-national-coordinator-health-it); and an evaluation of how the potential 
CMS-3310-P 48

objectives and measures align with the foundational goals of the program defined in the 

HITECH Act. 

In the Stage 2 proposed and final rules, we often identified the HIT Policy 

Committee recommendations as part of our discussion of the specific objectives and

measures, for example in the Stage 2 CPOE objective at 77 FR 43985. In this proposed 

rule for Stage 3 of meaningful use, although we have considered the HIT Policy 

Committee's recommendations in developing our proposed policies, we are not

referencing the recommendations in each individual proposed objective and measure as 

there are multiple factors that contribute to the selection of each proposed objective and 

measure. In addition, many of the HIT Policy Committee recommendations address

functions and standards that are part of the advanced use of certified EHR technology 

captured by one or more objectives proposed for Stage 3 of meaningful use. For 

example, the HIT Policy Committee has recommended an expansion of demographic data 

captured as structured data as well as a change to the related standards for use. However, 

this function and standard is required for certification of EHR technology for meaningful 

use and it is a required field for an electronic summary of care document for health 

information exchange. It is also to be included in the information accessible to a patient 

within their electronic patient record. Therefore, to provide clarity for readers, we 

provide a notation within Table 4 to identify alignment between the proposed Stage 3 

objectives and measures and the recommendations of the HIT Policy Committee for 

Stage 3 of meaningful use. We direct readers to the HIT Policy Committee 

recommendations available on HealthIT.gov for further information 
CMS-3310-P 49

(http://www.healthit.gov/facas/health-it-policy-committee/health-it-policy-committeerecommendations-national-coordinator-health-it). 

As mentioned previously, the statute includes certain foundational goals and 

requirements for meaningful use of certified EHR technology and the functions of that 

technology. Therefore, after review of the existing Stage 1 and Stage 2 objectives and 

measures of meaningful use, the recommendations of the HIT Policy Committee, and the 

foundational goals and requirements under the HITECH Act; we have identified eight 

key policy areas which represent the advanced use of EHR technology and align with the 

program's foundational goals and overall national health care improvement goals, such as 

those found in the CMS National Quality Strategy2. These eight policy areas provide the 

basis for the proposed objectives and measures for Stage 3 of meaningful use. They are 

included in Table 4 as follows: 

 

2 The National Quality Strategy: "HHS National Strategy for Quality Improvement in Health Care"

http://www.ahrq.gov/workingforquality/about.htm.
CMS-3310-P 50

TABLE 4: OBJECTIVES AND MEASURES FOR MEANINGFUL USE IN 2017 

AND SUBSEQUENT YEARS

Program Goal/Objective Delivery System Reform Goal Alignment

Protect Patient Health 

Information

Foundational to Meaningful Use and Certified EHR 

Technology*

Recommended by HIT Policy Committee

Electronic Prescribing (eRx) Foundational to Meaningful Use

National Quality Strategy Alignment

Clinical Decision Support (CDS)

Foundational to Certified EHR Technology

Recommended by HIT Policy Committee

National Quality Strategy Alignment

Computerized Provider Order 

Entry (CPOE)

Foundational to Certified EHR Technology

National Quality Strategy Alignment

Patient Electronic Access to 

Health Information

Recommended by HIT Policy Committee

National Quality Strategy Alignment

Coordination of Care through 

Patient Engagement

Recommended by HIT Policy Committee

National Quality Strategy Alignment

Health Information Exchange

(HIE)

Foundational to Meaningful Use and Certified EHR 

Technology

Recommended by HIT Policy Committee

National Quality Strategy Alignment

Public Health and Clinical Data 

Registry Reporting

Recommended by HIT Policy Committee

National Quality Strategy Alignment

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

These objectives build on the measures and EHR functionalities from the Stage 1 final 

rule and the Stage 2 final rule to advance the core functions of EHRs in a clinically 

relevant way that benefits providers and patients.

Under this proposal, which would apply to Stage 3 of meaningful use in 2017 and 

subsequent years, providers must successfully attest to these eight objectives and the 

associated measures (or meet the exclusion criteria for the applicable measure). As 

mentioned previously, the statute requires the Secretary to seek to improve the use of 

EHR and health care quality over time by requiring more stringent measures of 

meaningful use (see section 1848(o)(2)(A)(iii) of the Act). While we are proposing to 
CMS-3310-P 51

simplify the program by removing topped-out, redundant, and duplicative measures and 

aligning reporting periods for providers; we are maintaining the push to improve the use 

of EHRs over time through these eight objectives and the associated measures proposed 

for Stage 3 of meaningful use. These proposed objectives and measures include 

advanced EHR functions, use a wide range of structured standards in CEHRT, employ 

increased thresholds over similar Stage 1 and 2 measures, support more complex clinical 

and care coordination processes, and require enhanced care coordination through patient 

engagement through a flexibility structure of active engagement measures. 

These proposed objectives and their associated measures are further discussed in 

section II.A.1.(c).(2). of this proposed rule. CMS and ONC will continue to monitor and 

review performance on the objectives and measures finalized for Stage 3 to continue to 

evaluate them for rigor and efficacy and, if necessary, propose changes in future 

rulemaking. 

(d) Flexibility within Meaningful Use Objectives and Measures

We are proposing to incorporate flexibility within certain objectives proposed for 

Stage 3 for providers to choose the measures most relevant to their unique practice

setting. This means that as part of successfully demonstrating meaningful use, providers 

would be required to attest to the results for the numerators and denominators of all 

measures associated with an objective; however, a provider would only need to meet the 

thresholds for two of the three associated measures. The proposed Stage 3 objectives 

including flexible measure options are as follows: 

 Coordination of Care through Patient Engagement – Providers must meet the 
CMS-3310-P 52

thresholds of two of three measures and must attest to the numerators and denominators 

of all three measures.

 Health Information Exchange – Providers must meet the thresholds of two of

three measures and must attest to the numerators and denominators of all three measures.

 Public Health Reporting – EPs must report on three measures and eligible 

hospitals and CAHs must report on four measures.

We propose that if a provider meets the exclusion criteria for a particular measure 

within an objective which allows providers to meet the thresholds for two of three 

measures (namely, the Coordination of Care through Patient Engagement objective and 

the Health Information Exchange objective), the provider may exclude the measure and 

must meet the thresholds of the remaining two measures to meet the objective. If a 

provider meets the exclusion criteria for two measures for such an objective, the provider 

may exclude those measures and must meet the threshold of the remaining measure to 

meet the objective. If a provider meets the exclusion criteria for all three measures for 

such an objective, the provider may exclude those measures and would be considered to 

have met the objective. 

We discuss the proposed policy for exclusions for the public health reporting 

objective as well as the exclusion criteria in further detail within the individual objectives 

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

(e) EPs Practicing in Multiple Practices/Locations

For Stage 3, we propose to maintain the policy from the Stage 2 final rule 

(77 FR 53981) which states that to be a meaningful user, an EP must have 50 percent or 
CMS-3310-P 53

more of his or her outpatient encounters during the EHR reporting period at a 

practice/location or practices/locations equipped with CEHRT. An EP who does not 

conduct at least 50 percent of their patient encounters in any one practice/location would 

have to meet the 50 percent threshold through a combination of practices/locations 

equipped with CEHRT. For example, if the EP practices at a federally qualified health 

center (FQHC) and within his or her individual practice at two different locations, we 

would include in our review all three of these locations, and CEHRT would have to be 

available at one location or a combination of locations where the EP has 50 percent or 

more of his or her patient encounters. If CEHRT is only available at one location, then 

only encounters at this location would be included in meaningful use assuming this one 

location represents 50 percent or more of the EP's patient encounters. If CEHRT is 

available at multiple locations that collectively represent 50 percent or more of the EP's 

patient encounters, then all encounters from those locations would be included in 

meaningful use. In the Stage 2 final rule at (77 FR 53981), we defined patient encounter 

as any encounter where a medical treatment is provided or evaluation and management 

services are provided. This includes both individually billed events and events that are 

globally billed, but are separate encounters under our definition. 

In addition, in the Stage 2 final rule at (77 FR 53981) we defined a 

practice/location as equipped with CEHRT if the record of the patient encounter that 

occurs at that practice/location is created and maintained in CEHRT. This can be 

accomplished in the following three ways: CEHRT could be permanently installed at the 

practice/location, the EP could bring CEHRT to the practice/location on a portable 
CMS-3310-P 54

computing device, or the EP could access CEHRT remotely using computing devices at 

the practice/location. We propose to maintain these definitions for Stage 3. 

(f) Denominators 

The objectives for Stage 3 of meaningful use include percentage-based measures 

wherever possible. In the Stage 2 final rule, we included a discussion of the 

denominators used for the program that included the use of one of four denominators for 

each of the measures associated with the meaningful use objectives outlined in the 

Stage 2 final rule at 77 FR 53982 for EPs and 77 FR 53983 for eligible hospitals and 

CAHs. We focused on denominators because the action that moves something from the 

denominator to the numerator requires the use of CEHRT by the provider. For Stage 3 

we refer readers to each of the proposed objectives and measures for Stage 3 for the 

specific calculation of each denominator for each measure. Here, we simply outline the 

general proposals for determining the scope of the measure denominators. 

For EPs, the references used to define the scope of the potential denominators for 

measures include the following: 

 Unique patients seen by the EP during the EHR reporting period. The scope for 

this calculation may be limited to only those patients whose records are maintained in the 

EHR for the denominator of the measures for objectives other than those referencing 

"unique patients" as previously established in the Stage 2 final rule at (77 FR 53981). 

We propose to maintain the policy that EPs who practice at multiple locations or switch 

CEHRT during the EHR reporting period may determine for themselves the method for 

counting unique patients in the denominators to count unique patient across all locations 
CMS-3310-P 55

equipped with different CEHRT, or to count at each location equipped with CEHRT. In

cases where a provider switches CEHRT products at a single location during the EHR 

reporting period, they also have the flexibility to count a patient as unique on each side of 

the switch and not across it. EPs in these scenarios must choose one of these methods for 

counting unique patients and apply it consistently throughout the entire EHR reporting 

period.

A patient is seen by the EP when the EP has a real time physical encounter with 

the patient in which they render any service to the patient. We also consider a patient 

seen through telehealth as a patient "seen by the EP" (telehealth may include the 

commonly known telemedicine as well as telepsychiatry, telenursing, and other diverse 

forms of technology-assisted health care). However, in cases where the EP and the 

patient do not have a real time physical or telehealth encounter, but the EP renders a 

consultative service for the patient, such as reading an EKG, virtual visits, or 

asynchronous telehealth, the EP may choose whether to include the patient in the 

denominator as "seen by the EP." This is necessary so that these providers can avoid 

reporting a zero in the denominator and be able to satisfy meaningful use. However, we 

stress that once providers choose, they must maintain that denominator choice for the 

entire EHR reporting period and for all relevant meaningful use measures.

 Office visits. The denominators of the measures that reference "office visits"

may be limited to only those patients whose records are maintained using CEHRT. An 

office visit is defined as any billable visit that includes the following: 

++ Concurrent care or transfer of care visits,
CMS-3310-P 56

++ Consultant visits, or 

++ Prolonged physician service without direct, face-to-face patient contact (for 

example, telehealth). 

 All medication, laboratory, and diagnostic imaging orders created during the 

reporting period

 Transitions of care and referrals including at least--

++ When the EP is the recipient of the transition or referral, the first encounter 

with a new patient and encounters with existing patients where a summary of care record 

(of any type) is provided to the receiving EP; and 

++ When the EP is the initiator of the transition or referral, transitions and 

referrals ordered by the EP. 

Transitions of care are the movement of a patient from one setting of care to 

another. Referrals are cases where one provider refers a patient to another, but the 

referring provider maintains their care of the patient as well. For the purposes of 

distinguishing settings of care in determining the movement of a patient, we propose that 

a transition or referral may take place when a patient is transitioned or referred between 

providers with different billing identities, such as a different National Provider Identifier 

(NPI) or hospital CMS Certification Number (CCN). We also propose that in the cases 

where a provider has a patient who seeks out and receives care from another provider 

without a prior referral, the first provider may include that transition as a referral if the 

patient subsequently identifies the other provider of care. 

For further explanation of the terms "unique patient," "seen by the EP," "office 
CMS-3310-P 57

visit," "transitions of care," and "referrals," we refer readers to the discussion at 

77 FR 53982 through 53983. For eligible hospitals and CAHs, the references used to 

define the scope of the potential denominators for measures include the following:

 Unique patients admitted to the eligible hospital's or CAH's inpatient or 

emergency department during the EHR reporting period. 

 All medication, laboratory, and diagnostic imaging orders created during the 

reporting period.

 Transitions of care and referrals including at least--

++ When the hospital is the recipient of the transition or referral: all admissions 

to the inpatient and emergency departments; and

++ When the hospital is the initiator of the transition or referral: all discharges 

from the inpatient department; and after admissions to the emergency department when 

follow-up care is ordered by an authorized provider.

We propose that the explanation of the terms "unique patients," "transitions of 

care," and "referrals" stated previously for EPs would also apply for eligible hospitals and 

CAHs, and we refer readers to the discussion of those terms in the hospital context in the 

Stage 2 final rule (77 FR 53983 and 53984). We propose for Stage 3 to maintain the 

policy that admissions may be calculated using one of two methods (the observation 

services method and the all emergency department method), as described for Stage 2 at 

77 FR 53984. The method an eligible hospital or CAH chooses must be used uniformly 

across all measures for all objectives. 

We reiterate that all discharges from an inpatient setting are considered a 
CMS-3310-P 58

transition of care. We further propose for transitions from an emergency department, that 

eligible hospitals and CAHs must count any discharge where follow up care is ordered by 

an authorized provider regardless of the completeness of information available on the 

receiving provider. The eligible hospital or CAH should determine an internal policy 

applicable for the identification and capture of a patient's primary care provider or other 

relevant care team members for the purposes of ordering potential follow-up care. This 

will allow eligible hospitals and CAHs to better differentiate between discharges where 

care is ordered and discharges to home where no follow up care is ordered. 

(g) Patient-Authorized Representatives

In the Stage 3 Coordination of Care through Patient Engagement objective and the 

Patient Electronic Access objective outlined in section II.A.1.c.(2).(i). of this proposed 

rule, we propose the inclusion of patient-authorized representatives in the numerators as 

equivalent to the inclusion of the patient. We recognize that patients often consult with 

and rely on trusted family members and other caregivers to help coordinate care, 

understand health information, and make health care decisions. Accordingly, as part of 

these objectives, we encourage providers to provide access to health information to 

patient-authorized representatives in accordance with all applicable laws. We expect that 

patient-authorized representatives accessing such information under these objectives

could include a wide variety of sources, including caregivers and various family 

members. However, we expect that patient-authorized representatives with access to such 

health information will always act on the patient's behalf and in the patient's best 

interests, and will remain free from any potential or actual conflict of interest with the 
CMS-3310-P 59

patient. We further expect that the patient-authorized representatives would have the 

patient's best interests at heart and will act in a manner protective of the patient.

(h) Discussion of the Relationship of Meaningful Use to CEHRT

We propose to continue our policy of linking each meaningful use objective to the 

CEHRT definition and to ONC-established certification criteria. As with Stage 1 and 

Stage 2, EPs, eligible hospitals, and CAHs must use technology certified to the 

certification criteria in the ONC Health IT Certification Program to meet the objectives 

and associated measures for Stage 3 of meaningful use. In some instances, meaningful 

use objectives and measures may not be directly enabled by certification criteria of the 

Health IT Certification Program. For example, in e-Rx and public health reporting, the 

CEHRT definition requires criteria established by the Health IT Certification Program to 

be applied to the message being sent or received and for purposes of message 

transmission. However, to actually engage in e-Rx or public health reporting, there are 

many steps that must be taken to meet the requirements of the measure, such as 

contacting both parties and troubleshooting issues that may arise through the normal 

course of business. In these cases, the EP, eligible hospital, and CAH remain responsible 

for meeting the objectives and measures of meaningful use, but the way they do so is not 

entirely constrained by the CEHRT definition. 

(i) Discussion of the Relationship between a Stage 3 Meaningful Use Objective and its 

Associated Measure

We propose to continue our Stage 1 and 2 policy that regardless of any actual or 

perceived gaps between the measure of an objective and full compliance with the 
CMS-3310-P 60

objective, meeting the criteria of the measure means that the provider has met the 

objective for meaningful use in Stage 3. 

Objective 1: Protect Patient Health Information

The Health Insurance Portability and Accountability Act (HIPAA) was enacted in 

part to provide federal protections for individually identifiable health information (IIHI). 

The Secretary of HHS adopted what are commonly known as the HIPAA Privacy, 

Security and Breach Notification Rules (HIPAA Rules) to implement certain aspects of 

the HIPAA statute and the HITECH statute pertaining to a patient's IIHI. The Privacy 

Rule provides protections for most individually identifiable health information, in any 

form or media, whether electronic, paper, or oral, held by covered entities and business 

associates. The Security Rule specifies a series of administrative, physical, and technical 

standards that provide protections for most electronic individually identifiable health 

information, held by covered entities and business associates. Covered entities consist of 

most health care providers, health plans, and health care clearinghouses. Business 

associates consist of persons or organizations that perform certain functions or activities 

on behalf of, or provide certain services to, covered entities or other business associates 

that involve the use or disclosure of individually identifiable health information. 

Individually identifiable health information is information that relates to an individual's 

physical or mental health or condition, the provision of health care to an individual, or the 

payment for the provision of health care to an individual. Individually identifiable health 

information is information that identifies an individual directly or with respect to which

there is a reasonable basis to believe it can be used to identify an individual. The 
CMS-3310-P 61

individually identifiable health information protected by the HIPAA Rules is known as 

"protected health information" and that information in electronic form is known as 

"electronic protected health information" (ePHI). The Privacy Rule can be found at 

45 CFR Part160 and subparts A and E of part 164 and the Security Rule can be found at 

45 CFR Part160 and Subparts A and C of Part 164. Section 164.308(a)(1) of the 

Security Rule requires covered entities and business associates, among other things, to 

conduct a security risk analysis to assess the potential risks to the ePHI they create, 

receive, maintain, or transmit.

Consistent with HIPAA and its implementing regulations, and as we stated under 

both the Stage 1 and Stage 2 final rules (75 FR 44368 through 44369 and 77 FR 54002 

through 54003), protecting ePHI remains essential to all aspects of meaningful use under 

the EHR Incentive Programs. We remain cognizant that unintended or unlawful 

disclosures of ePHI could diminish consumer confidence in EHRs and the overall 

exchange of ePHI. Therefore, in both the Stage 1 and 2 final rules, we created a 

meaningful use core objective aimed at protecting patients' health care information. Most 

recently, we finalized at (77 FR 54002 and 54003), a Stage 2 meaningful use core 

objective requiring providers to "protect ePHI created or maintained by the certified EHR 

technology through the implementation of appropriate technical capabilities." The 

measure for this objective requires providers to conduct or review a security risk analysis 

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

the security (to include encryption) of data stored in CEHRT in accordance with 

requirements under 45 CFR 164.312 (a)(2)(iv) and 45 CFR 164.306(d)(3), implementing 
CMS-3310-P 62

security updates as necessary, and correcting identified security deficiencies as part of the 

provider's risk management process. For further detail on this objective, we refer readers 

to the Stage 2 proposed and final rules (77 FR 13716 through 13717 and 77 FR 54002).

In this Stage 3 proposed rule, we continue to emphasize the importance of 

protecting ePHI under the EHR Incentive Programs. With more and more users using 

electronic health records, we believe that adequate protection of ePHI remains 

instrumental to the continued success of the EHR Incentive Program. 

However, public comments on the Stage 2 final rule and subsequent comments 

received through public forums, suggest some confusion remains among providers 

between the requirements of this meaningful use objective and the requirements 

established under 45 CFR 164.308(a)(1), 45 CFR 164.312(a)(2)(iv) and 

45 CFR 164.306(d)(3) of the HIPAA Security Rule. Although we stressed that the 

objective and measure finalized relating to ePHI are specific to the EHR Incentive 

Programs, and further added that compliance with the requirements in the HIPAA 

Security Rule falls outside the scope of this rulemaking, we nonetheless continued to 

receive inquiries about the relationship between our objective and the HIPAA Rules. 

Therefore, for Stage 3, in order to alleviate provider confusion and simplify the EHR 

Incentive Program, we are proposing to maintain the previously finalized Stage 2 

objective on protecting ePHI. However, we propose further explanation of the security 

risk analysis timing and review requirements for purposes of meeting this objective and 

associated measure for Stage 3. 
CMS-3310-P 63

Proposed Objective: Protect electronic protected health information (ePHI) created or 

maintained by the certified EHR technology (CEHRT) through the implementation of 

appropriate technical, administrative, and physical safeguards. 

For the proposed Stage 3 objective, we have added language to the security 

requirements for the implementation of appropriate technical, administrative, and 

physical safeguards. We propose to include administrative and physical safeguards

because an entity would require technical, administrative, and physical safeguards to 

enable it to implement risk management security measures to reduce the risks and 

vulnerabilities identified. Technical safeguards alone are not enough to ensure the 

confidentiality, integrity, and availability of ePHI. Administrative safeguards (for 

example, risk analysis, risk management, training, and contingency plans) and physical 

safeguards (for example, facility access controls, workstation security) are also required 

to protect against threats and impermissible uses or disclosures to ePHI created or 

maintained by CEHRT. 

Proposed Measure: Conduct or review a security risk analysis in accordance with the 

requirements under 45 CFR 164.308(a)(1), including addressing the security (including

encryption) of data stored in CEHRT in accordance with requirements under 

45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), implement security updates as 

necessary, and correct identified security deficiencies as part of the provider's risk 

management process. 

Under this proposed measure, a risk analysis must assess the risks and 

vulnerabilities to ePHI created or maintained by the CEHRT and must be conducted or 
CMS-3310-P 64

reviewed for each EHR reporting period, which, as proposed in this rule, would be a full 

calendar year, and any security updates and deficiencies identified should be included in 

the provider's risk management process and implemented or corrected as dictated by that 

process. 

To address inquiries about the relationship between this measure and the HIPAA 

Security Rule, we explain that the requirement of this proposed measure is narrower than 

what is required to satisfy the security risk analysis requirement under 

45 CFR 164.308(a)(1). The requirement of this proposed measure is limited to annually 

conducting or reviewing a security risk analysis to assess whether the technical, 

administrative, and physical safeguards and risk management strategies are sufficient to 

reduce the potential risks and vulnerabilities to the confidentiality, availability, and 

integrity of ePHI created by or maintained in CEHRT. In contrast, the security risk 

analysis requirement under 45 CFR 164.308(a)(1) must assess the potential risks and 

vulnerabilities to the confidentiality, availability, and integrity of all ePHI that an 

organization creates, receives, maintains, or transmits. This includes ePHI in all forms of 

electronic media, such as hard drives, floppy disks, CDs, DVDs, smart cards or other 

storage devices, personal digital assistants, transmission media, or portable electronic 

media.

We propose that the timing or review of the security risk analysis to satisfy this 

proposed measure must be as follows: 

 EPs, eligible hospitals, and CAHs must conduct the security risk analysis upon 

installation of CEHRT or upon upgrade to a new Edition of certified EHR Technology. 
CMS-3310-P 65

The initial security risk analysis and testing may occur prior to the beginning of the first 

EHR reporting period using that certified EHR technology. 

 In subsequent years, a provider must review the security risk analysis of the 

CEHRT and the administrative, physical, and technical safeguards implemented, and 

make updates to its analysis as necessary, but at least once per EHR reporting period. 

We note that providers have several resources available for strategies and 

methods for securing ePHI. Completing a security risk analysis requires a time 

investment, and may necessitate the involvement of security, health IT, or system IT staff 

or support teams at your facility. The Office for Civil Rights (OCR) provides broad scale 

guidance on security risk analysis requirements at: 

http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/rafinalguidancepdf.pdf. 

In addition, other tools and resources are available to assist providers in the 

process. For example, the Office of the National Coordinator for Health IT (ONC) 

provides guidance and a Security Risk Assessment (SRA) tool created in conjunction 

with OCR on its website at: http://www.healthit.gov/providers-professionals/securityrisk-assessment-tool. The SRA Tool is a self-contained application available at no cost to 

the provider. There are a total of 156 questions and resources are included with each 

question to--

 Assist in understanding the context of the question

 Consider the potential impacts to ePHI if the requirement is not met

 See the actual safeguard language of the HIPAA Security Rule
CMS-3310-P 66

In addition, the SRA Tool assists a provider by suggesting when corrective action 

may be required for a particular item. This tool is not required by the HIPAA Security 

Rule, but is one means by which providers and professionals in small and medium sized 

practices may perform a security risk analysis. 

We further note that the 2015 Edition proposed rule published elsewhere in this 

issue of the Federal Register includes an auditable events and tamper-resistance

criterion which is known as an "audit log" which can be a valuable resource in ensuring 

the protection of ePHI. While we recognize there may be legitimate instances where the 

function must be disabled for a short time, we strongly recommend providers ensure this 

function is enabled at all times when the CEHRT is in use. The audit log function serves 

to ensure consistent protection of ePHI as well as providing support in mitigating risk in 

other areas such as patient safety, adverse events, and in the event of any potential 

breach.

We emphasize that our discussion of this measure as it relates to 

45 CFR 164.308(a)(1) is only relevant for purposes of the meaningful use requirements 

and is not intended to supersede or satisfy the broader, separate requirements under the 

HIPAA Security Rule and other rulemaking. Compliance with the requirements in the 

HIPAA Security Rule fall outside of the scope of this rulemaking. Compliance with 

42 CFR Part 2 and state mental health privacy and confidentiality laws also fall outside 

the scope of this rulemaking. EPs, eligible hospitals, or CAHs affected by 42 CFR Part 2 

should consult with the Substance Abuse and Mental Health Services Administration 

(SAMHSA) or State authorities. 
CMS-3310-P 67

We welcome public comments on this proposal. 

Objective 2: Electronic Prescribing

For Stage 3, we propose to maintain the objective and measure finalized in the 

Stage 2 final rule for electronic prescribing for EPs, with minor changes. In the Stage 2 

final rule, we included for eligible hospitals and CAHs a menu set objective for the 

electronic prescription of discharge medications. We are proposing to include the Stage 2 

menu objective, with a modification to increase the threshold, as a required objective for 

Stage 3 of meaningful use for eligible hospitals and CAHs. 

For a full discussion of electronic prescribing as a meaningful use objective in 

the Stage 2 final rule, we direct readers to (77 FR 53989 through 53990 for EPs and 

77 FR 54035 through 54036 for eligible hospitals and CAHs). 

Proposed Objective: EPs must generate and transmit permissible prescriptions 

electronically, and eligible hospitals and CAHs must generate and transmit permissible 

discharge prescriptions electronically (eRx). 

As discussed in the Stage 2 final rule (77 FR 53989), transmitting the prescription 

electronically promotes efficiency and patient safety through reduced communication 

errors. It also allows the pharmacy or a third party to automatically compare the 

medication order to others they have received for the patient that works in conjunction 

with clinical decision support interventions enabled at the generation of the prescription. 

While the EP performance rate across all years and stages of participation indicate wide

spread adoption, with the median rate at 89 percent for Stage 1 and 92 percent for Stage 
CMS-3310-P 68

2

3

, we believe continued support of this objective is warranted to support the continued 

development of the ePrescribing marketplace. The continued expansion of the number 

and variety of products helps to reduce entry barriers and proliferate important standards 

for ePrescribing for a wide range of providers beyond those eligible for the EHR 

Incentive Programs. This represents a benefit to patients and to population health 

through a potential overall reduction in the occurrence of prescription drug related 

adverse events. For eligible hospitals and CAHs, the performance rate among Stage 2 

providers selecting the measure is higher than the 10 percent threshold and has increased 

since the previous report(median rate is 764percent). This opportunity to expand on 

early success, combined with the continued expansion of the pharmacy market 

acceptance of electronic prescriptions leads CMS to believe providers can meet an even 

higher threshold and should be encouraged to do so. 

We propose to continue to define "prescription" as the authorization by a provider 

to dispense a drug that would not be dispensed without such authorization. This includes 

authorization for refills of previously authorized drugs. We propose to continue to 

generally define a "permissible prescription" as all drugs meeting the definition of 

prescription not listed as a controlled substance in Schedules II-V (DEA website at 

http://www.deadiversion.usdoj.gov/schedules/index.html (77 FR 53989) with a slight 

modification to allow for inclusion of scheduled drugs where such drugs are permissible 

to be electronically prescribed. We note that the electronic prescribing of controlled 

 

3 Data may be found on the CMS website data and program reports page: https://www.cms.gov/Regulations-andGuidance/Legislation/EHRIncentivePrograms/DataAndReports.html.

4 Data may be found on the CMS website data and program reports page: https://www.cms.gov/Regulations-andGuidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
CMS-3310-P 69

substances (EPCS) is now legal in many states. This functionality provides prescribers 

with a way to manage treatments for patients with pain electronically and also deters 

creation of fraudulent prescriptions, which is a major concern in combating opioid misuse 

and abuse. While the technology may, in many instances, be in place to support EPCS, 

workflow challenges and additional modifications may need to occur to meet the 

requirements of Drug Enforcement Agency regulations (75 FR 16236). However, as 

Stage 3 would not begin until January of 2017 and would not be required until January of 

2018, it is possible that significant progress in the availability of products enabling the 

electronic prescribing of controlled substances may occur. Therefore, we are proposing 

that providers who practice in a state where controlled substances may be electronically 

prescribed who wish to include these prescriptions in the numerator and denominator 

may do so under the definition of "permissible prescriptions" for their practice. If a 

provider chooses to include such prescriptions, they must do so uniformly across all 

patients and across all allowable schedules for the duration of the EHR reporting period.

For Stage 2, we requested comment on whether over-the-counter (OTC) 

medicines should be included in the definition of a prescription for this objective and 

determined that they should be excluded. For further information on that discussion, we 

direct readers to (77 FR 53989 and 53990). We maintain that OTC medicines will not be 

routinely electronically prescribed and propose to continue to exclude them from the 

definition of a prescription. However, we encourage public comment on this assumption 

and whether OTC medicines should be included in this objective for Stage 3. 
CMS-3310-P 70

In the Stage 2 final rule at (77 FR 53989), we discussed several different 

workflow scenarios that are possible when an EP prescribes a drug for a patient and that 

these differences in transmissions create differences in the need for standards. We 

propose to maintain this policy for Stage 3 for EPs and extend it to eligible hospitals and 

CAHs so that only a scenario in which a provider-- 

 Prescribes the drug;

 Transmits it to a pharmacy independent of the provider's organization; and 

 The patient obtains the drug from that pharmacy

requires the use of standards to ensure that the transmission meets the goals of electronic 

prescribing. In that situation, standards can ensure the whole process functions reliably. 

In all cases under this objective, the provider needs to use CEHRT as the sole means of 

creating the prescription, and when transmitting to an external pharmacy that is 

independent of the provider's organization, such transmission must be pursuant to ONC 

Health IT Certification Program criteria. 

Proposed EP Measure: More than 80 percent of all permissible prescriptions written by 

the EP are queried for a drug formulary and transmitted electronically using CEHRT. 

In Stage 1 of meaningful use, we adopted a measure of more than 40 percent of 

all permissible prescriptions written by the EP are transmitted electronically using 

CEHRT. In the Stage 1 final rule (75 FR 44338), we acknowledged that there were 

reasons why a patient may prefer a paper prescription such as the desire to shop for the 

best price (especially for patients in the Part D "donut hole''), the indecision about 
CMS-3310-P 71

whether to have the prescription filled locally or by mail order, and the desire to use a 

manufacturer coupon (except in the Part D program) to obtain a discount. 

In Stage 2, we adopted a measure of more than 50 percent of all permissible 

prescriptions written by the EP are queried for a drug formulary and transmitted 

electronically using CEHRT. Our analysis of attestation data from Stages 1 and 2 shows 

that the median performance on this measure for Stage 1 EPs is 89 percent and for 

Stage 2 EPs is 92 percent, which demonstrates that the 50 percent threshold does not 

exceed the ceiling created by patient preferences5. We believe that with continued 

experience with this objective and the continued expansion of the pharmacy market 

acceptance of electronic prescriptions, providers can meet an even higher threshold and 

should be encouraged to do so in line with the statutory directive to seek to improve the 

use of EHRs and health care quality over time by requiring more stringent measures of 

meaningful use (see section 1848(o)(2)(A)(iii) of the Act). Therefore, we are proposing a 

threshold of 80 percent for this measure for Stage 3. 

We propose to maintain for Stage 3 the exclusion from Stage 2 for EPs who write 

fewer than 100 permissible prescriptions during the EHR reporting period. We also 

propose to maintain for Stage 3 the exclusion from Stage 2 if no pharmacies within a 

10-mile radius of an EP's practice location at the start of his or her EHR reporting period 

accept electronic prescriptions (77 FR 53990). This is 10 miles in any straight line from 

the practice location independent of the travel route from the practice location to the 

pharmacy. For EPs practicing at multiple locations, they are eligible for the exclusion if 

 

5 Data can be found on the CMS website data and program reports page: https://www.cms.gov/Regulations-andGuidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
CMS-3310-P 72

any of their practice locations equipped with CEHRT meet this criterion. An EP would 

not be eligible for this exclusion if he or she is part of an organization that owns or 

operates its own pharmacy within the 10-mile radius regardless of whether that pharmacy 

can accept electronic prescriptions from EPs outside of the organization. 

To calculate the percentage, CMS and ONC have worked together to define the 

following for this objective: 

Denominator: Number of prescriptions written for drugs requiring a prescription 

in order to be dispensed other than controlled substances during the EHR reporting period 

or Number of prescriptions written for drugs requiring a prescription in order to be 

dispensed during the EHR reporting period. 

Numerator: The number of prescriptions in the denominator generated, queried 

for a drug formulary, and transmitted electronically using CEHRT. 

Threshold: The resulting percentage must be more than 80 percent in order for an 

EP to meet this measure. 

Exclusions: Any EP who: (1) writes fewer than 100 permissible prescriptions 

during the EHR reporting period; or (2) does not have a pharmacy within their 

organization and there are no pharmacies that accept electronic prescriptions within 

10 miles of the EP's practice location at the start of his or her EHR reporting period. 

Proposed Eligible Hospital/CAH Measure: More than 25 percent of hospital discharge 

medication orders for permissible prescriptions (for new and changed prescriptions) are 

queried for a drug formulary and transmitted electronically using CEHRT. 
CMS-3310-P 73

In the Stage 2 final rule, we included in this measure new, changed, and refill 

prescriptions ordered during the course of treatment of the patient while in the hospital 

(77 FR 54036). We are proposing to limit this measure for Stage 3 to only new and 

changed prescriptions. We believe this limitation is appropriate because prescriptions 

that originate prior to the hospital stay, and that remain unchanged, would be within the 

purview of the original prescriber, and not hospital staff or attending physicians. We 

propose to include this limitation as we believe that in most cases a hospital would not 

issue refills for medications that were not authorized or altered during a patient's hospital 

stay. With this new proposal, we invite public comment on whether a hospital would 

issue refills upon discharge for medications the patient was taking when they arrived at 

the hospital and, if so, whether distinguishing those refill prescriptions from new or 

altered prescriptions is unnecessarily burdensome for the hospital. 

Our review of the Stage 2 attestation data for eligible hospitals and CAHs 

indicates performance levels of 53 percent at the median and 31 percent for the lowest 

quartile (www.cms.gov/ehrincentiveprograms Data and Reports). Thus, we are 

proposing to increase the threshold for the measure from 10 percent to 25 percent for 

Stage 3 of meaningful use for eligible hospitals and CAHs. 

We propose to maintain the Stage 2 exclusion for any eligible hospital or CAH 

that does not have an internal pharmacy that can accept electronic prescriptions and is not 

located within 10 miles of any pharmacy that accepts electronic prescriptions at the start 

of their EHR reporting period (77 FR 54036).
CMS-3310-P 74

We recognize that not every patient will have a formulary that is relevant for him 

or her. If a relevant formulary is available, then the information can be provided. If there 

is no formulary for a given patient, the comparison could return a result of formulary 

unavailable for that patient and medication combination, and the provider may count the 

prescription in the numerator if they generate and transmit the prescription electronically 

as required by the measure. 

To calculate the percentage, CMS and ONC have worked together to define the 

following for this objective: 

Denominator: The number of new or changed prescriptions written for drugs 

requiring a prescription in order to be dispensed other than controlled substances for 

patients discharged during the EHR reporting period. 

Numerator: The number of prescriptions in the denominator generated, queried 

for a drug formulary and transmitted electronically. 

Threshold: The resulting percentage must be more than 25 percent in order for an 

eligible hospital or CAH to meet this measure. 

Exclusion: Any eligible hospital or CAH that does not have an internal pharmacy 

that can accept electronic prescriptions and there are no pharmacies that accept electronic 

prescriptions within 10 miles at the start of their EHR reporting period. 

We invite public comment on these proposals. 
CMS-3310-P 75

Objective 3: Clinical Decision Support

Proposed Objective: Implement clinical decision support (CDS) interventions 

focused on improving performance on high-priority health conditions.

Clinical decision support at the relevant point of care is an area of health IT in 

which significant evidence exists for substantial positive impact on the quality, safety, 

and efficiency of care delivery. For Stage 2, we finalized an objective for the use of CDS 

to improve performance on high-priority health conditions, and two associated measures 

(77 FR 53995 through 53998). The first measure requires a provider to implement five 

CDS interventions related to four or more CQMs at a relevant point in patient care for the 

entire EHR reporting period. Absent four CQMs related to the provider's scope of 

practice or patient population, the CDS interventions must be related to high-priority 

health conditions. At least one of the CDS interventions should be related to improving 

healthcare efficiency. To meet the Stage 2 Clinical Decision Support objective, providers 

must implement the CDS intervention at a relevant point in patient care when the 

intervention can influence clinical decision making before an action is taken on behalf of 

the patient. Although we leave it to the provider's clinical discretion to determine the 

relevant point in patient care when such interventions will be most effective, the 

interventions must be presented through Certified EHR Technology to a licensed

healthcare professional who can exercise clinical judgment about the decision support 

intervention before an action is taken on behalf of the patient. For the second measure, 

we consolidated the Stage 1 "drug-drug/drug-allergy interaction checks" objective into 

the Stage 2 CDS objective in the Stage 2 final rule (77 FR 53995 through 53998). The 
CMS-3310-P 76

second measure requires a provider to enable and implement the functionality for 

drug-drug and drug-allergy interaction checks for the entire EHR reporting period. We 

also finalized an exclusion for the second measure for any EP who writes fewer than 

100 medication orders during the EHR reporting period. 

For Stage 3 of meaningful use, we propose to maintain the Stage 2 objective with 

slight modifications and further explanation of the relevant point of care, the types of 

CDS allowed, and the selection of a CDS applicable to a provider's scope of practice and 

patient population. 

First, we offer further explanation of the concept of the relevant point of care and

note that providers should implement the CDS intervention at a relevant point in clinical 

workflows when the intervention can influence clinical decision making before 

diagnostic or treatment action is taken in response to the intervention. Second, many 

providers may associate CDS with pop-up alerts; however, these alerts are not the only 

method of providing CDS. CDS should not be viewed as simply an interruptive alert, 

notification, or explicit care suggestion. Well-designed CDS encompasses a variety of 

workflow-optimized information tools, which can be presented to providers, clinical and 

support staff, patients, and other caregivers at various points in time. These may include 

but are not limited to: computerized alerts and reminders for providers and patients; 

information displays or links; context-aware knowledge retrieval specifications which 

provide a standard mechanism to incorporate information from online resources 

(commonly referred to as InfoButtons); clinical guidelines; condition-specific order sets; 

focused patient data reports and summaries; documentation templates; diagnostic 
CMS-3310-P 77

support; and contextually relevant reference information. These functionalities may be 

deployed on a variety of platforms (that is, mobile, cloud-based, installed).6 We 

encourage innovative efforts to use CDS to improve care quality, efficiency, and 

outcomes. HIT functionality that builds upon the foundation of an EHR to provide 

persons involved in care processes with general and person-specific information, 

intelligently filtered and organized, at appropriate times, to enhance health and health 

care. CDS is not intended to replace clinician judgment, but rather, is a tool to assist care 

team members in making timely, informed, and higher quality decisions.

We propose to retain both measures of the Stage 2 objective for Stage 3 and we 

are proposing that these additional options mentioned previously on the actions, 

functions, and interventions may constitute CDS for purposes of meaningful use would 

meet the measure requirements outlined in the proposed measures. 

Proposed Measures: EPs, eligible hospitals, and CAHs must satisfy both measures in 

order to meet the objective:

Measure 1: Implement five clinical decision support interventions related to four or 

more CQMs at a relevant point in patient care for the entire EHR reporting period. 

Absent four CQMs related to an EP, eligible hospital, or CAH's scope of practice or 

patient population, the clinical decision support interventions must be related to 

high-priority health conditions. 

Measure 2: The EP, eligible hospital, or CAH has enabled and implemented the 

 

6

FDASIA Health IT report available on the FDA website at: 

http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/C

DRHReports/UCM391521.pdf.
CMS-3310-P 78

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

reporting period.

Exclusion: For the second measure, any EP who writes fewer than 100 

medication orders during the EHR reporting period.

We recommend that providers explore a wide range of potential CDS 

interventions and determine the best mix for their practice and patient population. There 

are a wide range of CQMs which providers may implement in conjunction with the CDS. 

We refer readers to the CMS eCQM Library 

(www.cms.gov/ehrincentiveprograms/ecqmlibrary) for a list of the CQMs currently in 

use and under development for CMS programs and the associated National Quality 

Strategy domain categories. 

In alignment with the HHS National Quality Strategy goals

7

, providers are 

encouraged to implement CDS related to quality measurement and improvement goals on 

the following areas:

 Preventive care.

 Chronic condition management.

 Heart disease and hypertension.

 Appropriateness of diagnostic orders or procedures such as labs, diagnostic 

imaging, genetic testing, pharmacogenetic and pharmacogenomic test result support or 

other diagnostic testing.

 Advanced medication-related decision support, to include pharmacogenetic and 

pharmacogenomic test result support.

 

7 HHS National Quality Strategy: http://www.ahrq.gov/workingforquality/.
CMS-3310-P 79

An example of a potential CDS a provider may include which highlights the 

proposed expansion of the variety of workflow-optimized tools available for providers,

and the link between a CDS and a high priority health condition, may be found in the use 

of treatment protocols and algorithms within the Million Hearts initiative. The Million 

Hearts initiative emphasizes the use of treatment protocols which can be embedded 

throughout the clinical workflow for hypertension control to standardize a team's or 

system's approach to achieving outcomes of interest. These treatment protocols or 

algorithms can expand the number of care team members that can assist in achieving 

desired outcomes; lend clarity, efficiency, and cost-effectiveness to selection of 

medications; and specify intervals and processes for patient follow up for care related to 

hypertension. For further information on this example, we direct readers to the Million 

Hearts initiative protocols http://millionhearts.hhs.gov/resources/protocols.html. In this 

example, these CDS interventions are applied to utilize standardized treatment 

approaches or protocols specific to hypertension control; however, we emphasize that 

similar strategies and approaches to the implementation of a variety of CDS can be 

widely applied. Another relevant example is clinical decision support in certified EHR 

technology that is used for consultation regarding appropriate use criteria for applicable 

imaging services as outlined in section 218 of the "Protecting Access to Medicare Act of 

2014" which includes provisions focused on promoting evidence based care. We 

welcome public comments on the proposals.

As in the Stage 2 final rule (77 FR 53997), we do not propose to require the 

provider to report a change in performance on individual CQMs either independently or 
CMS-3310-P 80

in relation to the paired CDS. Rather, we recommend each provider set internal goals for 

improved performance using the CQM, or related set of CQMs, as indicators for their 

own reference when selecting and implementing a CDS intervention. We note that for 

CDS and CQM pairings, we recommend providers focus on the use of CQMs which 

measure patient outcomes (also known as outcome measures), as preferred over CQMs 

which measure clinical process without consideration of a particular outcome (also 

known as process measures). Outcome measure CQMs are designed to provide a 

patient-centered and outcome-focused indicator for quality improvement goal-setting and 

planning. Where possible, we recommend providers implement CDS interventions which 

relate to care quality improvement goals and a related outcome measure CQM. However,

for specialty hospitals and certain EPs, if there are no CQMs which are outcome 

measures related to their scope of practice, the provider should implement a CDS 

intervention related to a CQM process measure; or if none of the available CQMs apply, 

the provider should apply an intervention that he or she believes will be effective in 

improving the quality, safety, or efficiency of patient care.

CMS and ONC are committed to harmonizing the quality improvement 

ecosystem, refining and developing outcome measures, and aligning standards for CDS 

and quality measurement. Work is underway in the ONC Standards and Interoperability 

Framework to align and develop a shared quality improvement data model and technical 

expression standards for both CDS and quality measurement. Upon successful 

completion, such standards may be considered for inclusion in future quality 

measurement and certification rulemaking.
CMS-3310-P 81

Given the wide range of CDS interventions currently available and the continuing 

development of new technologies, we do not believe that any EP, eligible hospital, or 

CAH would be unable to identify and implement five CDS interventions as previously 

described. Therefore, we do not propose any exclusion for the first measure of this 

objective.

Objective 4: Computerized Provider Order Entry

In the Stage 2 final rule, we expanded the use of computerized provider order 

entry (CPOE) from the Stage 1 objective requiring only medication orders to be entered 

using CPOE to include laboratory orders and radiology orders. For a full discussion of 

this expansion, we direct readers to (77 FR 53985 through 53989). We maintain CPOE 

continues to represent an opportunity for providers to leverage technology to capture 

these orders to reduce error and maximize efficiencies within their practice, therefore we 

are proposing to maintain the use of CPOE for these orders as an objective of meaningful 

use for Stage 3.

Proposed Objective: Use computerized provider order entry (CPOE) for medication, 

laboratory, and diagnostic imaging orders directly entered by any licensed healthcare 

professional, credentialed medical assistant, or a medical staff member credentialed to 

and performing the equivalent duties of a credentialed medical assistant; who can enter 

orders into the medical record per state, local, and professional guidelines. 

We propose to continue to define CPOE as the provider's use of computer 

assistance to directly enter clinical orders (for example, medications, consultations with 

other providers, laboratory services, imaging studies, and other auxiliary services) from a 

computer or mobile device. The order is then documented or captured in a digital, 
CMS-3310-P 82

structured, and computable format for use in improving safety and efficiency of the 

ordering process. 

We propose to continue our policy from the Stage 2 final rule that the orders to be 

included in this objective are medication, laboratory, and radiology orders as such orders 

are commonly included in CPOE implementation and offer opportunity to maximize 

efficiencies for providers. However, for Stage 3, we are proposing to expand the 

objective to include diagnostic imaging, which is a broader category including other 

imaging tests such as ultrasound, magnetic resonance, and computed tomography in 

addition to traditional radiology. This change addresses the needs of specialists and 

allows for a wider variety of clinical orders relevant to particular specialists to be 

included for purposes of measurement.

In Stage 3, we propose to continue the policy from the Stage 2 final rule at 

77 FR 53986 that orders entered by any licensed healthcare professional or credentialed 

medical assistant would count toward this objective. A credentialed medical assistant 

may enter orders if they are credentialed to perform the duties of a medical assistant by a 

credentialing body other than the employer. If a staff member of the eligible provider is 

appropriately credentialed and performs assistive services similar to a medical assistant,

but carries a more specific title due to either specialization of their duties or to the 

specialty of the medical professional they assist, orders entered by that staff member 

would be included in this objective. We further note that medical staff whose 

organizational or job title, or the title of their credential, is other than medical assistant 

may enter orders if these staff are credentialed to perform the equivalent duties of a 
CMS-3310-P 83

credentialed medical assistant by a credentialing body other than their employer and 

perform such duties as part of their organizational or job title. We defer to the provider's 

discretion to determine the appropriateness of the credentialing of staff to ensure that any 

staff entering orders have the clinical training and knowledge required to enter orders for 

CPOE. This determination must be made by the EP or representative of the eligible 

hospital or CAH based on-- 

 Organizational workflows;

 Appropriate credentialing of the staff member by an organization other than the 

employing organization;

 Analysis of duties performed by the staff member in question; and 

 Compliance with all applicable federal, state, and local laws and professional 

guidelines. 

However, as stated in the Stage 2 final rule at 77 FR 53986, it is apparent that the 

prevalent time when CDS interventions are presented is when the order is entered into 

CEHRT, and that not all EHRs also present CDS when the order is authorized (assuming 

such a multiple step ordering process is in place). This means that the person entering the 

order would be required to enter the order correctly, evaluate a CDS intervention either 

using their own judgment or through accurate relay of the information to the ordering 

provider, and then either make a change to the order based on the information provided 

by the CDS intervention or bypass the intervention. The execution of this role represents 

a significant impact on patient safety; therefore, we continue to maintain for Stage 3 that 

a layperson is not qualified to perform these tasks. We believe that the order must be 
CMS-3310-P 84

entered by a qualified individual. We further propose that if the individual entering the 

orders is not the licensed healthcare professional, the order must be entered with the 

direct supervision or active engagement of a licensed healthcare professional.

We propose to maintain for Stage 3 our existing policy for Stages 1 and 2 that the 

CPOE function should be used the first time the order becomes part of the patient's 

medical record and before any action can be taken on the order. The numerator of this 

objective also includes orders entered using CPOE initially when the patient record 

became part of the certified EHR. This does not include paper orders entered initially 

into the patient record and then transferred to CEHRT by other individuals at a later time, 

nor does it include orders entered into technology not compliant with the CEHRT 

definition and transferred into the CEHRT at a later time. In addition, based on the 

discussion in the Stage 2 final rule (77 FR 53986), we propose to maintain for Stage 3 

that "protocol" or "standing" orders may be excluded from this objective. The defining 

characteristic of these orders is that they are not created due to a specific clinical 

determination by the ordering provider for a given patient, but rather are predetermined 

for patients with a given set of characteristics (for example, administer medication X and 

order lab Y for all patients undergoing a certain specific procedure or refills for given 

medication). We agree that this category of orders warrant different considerations than 

orders that are due to a specific clinical determination by the ordering provider for a 

specific patient. Therefore, we allow providers to exclude orders that are predetermined 

for a given set of patient characteristics or for a given procedure from the calculation of 

CPOE numerators and denominators. However, the exclusion of this type of order may 
CMS-3310-P 85

not be a blanket policy for patients presenting with a specific diagnosis or symptom 

which requires the evaluation and determination of the provider for the order. 

We propose to maintain the Stage 2 description of "laboratory services" as any 

service provided by a laboratory that could not be provided by a non-laboratory for the 

CPOE objective for Stage 3 (77 FR 53984). We also propose to maintain for Stage 3 the 

Stage 2 description of "radiologic services" as any imaging service that uses electronic 

product radiation (77 FR 53986). Even though we are proposing to expand the CPOE 

objective from radiology orders to all diagnostic imaging orders, this description would 

still apply for radiology services within the expanded objective. 

We invite public comment on these proposals. 

Proposed Measures: An EP, eligible hospital or CAH must meet all three measures. 

Proposed Measure 1: More than 80 percent of medication orders created by the 

EP or authorized providers of the eligible hospital's or CAH's inpatient or emergency 

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

computerized provider order entry;

Proposed Measure 2: More than 60 percent of laboratory orders created by the 

EP or authorized providers of the eligible hospital's or CAH's inpatient or emergency 

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

computerized provider order entry; and

Proposed Measure 3: More than 60 percent of diagnostic imaging orders created 

by the EP or authorized providers of the eligible hospital's or CAH's inpatient or 

emergency department (POS 21 or 23) during the EHR reporting period are recorded 
CMS-3310-P 86

using computerized provider order entry.

We propose to continue a separate percentage threshold for all three types of 

orders: medication, laboratory, and diagnostic imaging. We continue to believe that an 

aggregate denominator cannot best capture differentiated performance on the individual 

order types within the objective, and therefore maintain a separate denominator for each 

order type. We propose to retain exclusionary criteria from Stage 2 for those EPs who so 

infrequently issue an order type specified by the measures (write fewer than 100 of the 

type of order), that it is not practical to implement CPOE for that order type. 

Based on our review of attestation data from Stages 1 and 2 demonstrating 

provider performance on the CPOE measures, we propose to increase the threshold for 

medication orders to 80 percent and to increase the threshold for diagnostic imaging 

orders and laboratory orders to 60 percent. Median performance for Stage 1 on 

medication orders is 95 percent for EPs and 93 percent foreligible hospitals and CAHs. 

Stage 2 median performance on laboratory and radiology orders is 80 percent and 

83 percent for eligible hospitals and CAHs and 100 percent for EPs for both measures8. 

We believe it is reasonable to expect the actual use of CPOE for medication orders to

increase from 60 percent in Stage 2 to 80 percent in Stage 3 and the actual use of CPOE 

for diagnostic imaging and laboratory orders to increase from 30 percent in Stage 2 to 

60 percent in Stage 3. We note that despite the expansion of the category for radiology 

orders to diagnostic imaging orders, we do not anticipate a negative impact on the ability 

of providers to meet the higher threshold as the adoption of the expanded functionality 

 

8 Data can be found on the CMS website data and program reports page: https://www.cms.gov/Regulations-andGuidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
CMS-3310-P 87

does not require additional workflow implementation and allows for inclusion of a wider 

range of orders already being captured by many providers. Therefore, for medication 

orders we propose the threshold at 80 percent and for diagnostic imaging and laboratory 

orders we propose the threshold at 60 percent for Stage 3. 

In the Stage 2 final rule, we addressed the concern posed when calculating a 

denominator of all orders entered into the CEHRT while limiting the numerator to only 

those entered into CEHRT using CPOE (77 FR 53987 through 53988). Potentially, this 

would exclude those orders that are never entered into the CEHRT in any manner. The 

provider would be responsible for including those orders in their denominator. However, 

we believe that providers using CEHRT use it as the patient's medical record; therefore, 

an order not entered into CEHRT would be an order that is not entered into a patient's 

medical record. For this reason, we expect that orders given for patients that are never 

entered into the CEHRT to be few in number or non-existent. While our experience with 

both Stage 1 and Stage 2 of meaningful use has shown that a denominator of all orders 

created by the EP or in the hospital would not be unduly burdensome for providers and 

would create a better measurement for CPOE usage, particularly for EPs who 

infrequently order medications, this does not guarantee such a denominator would be 

feasible for all providers. We invite comments on whether to continue to allow, but not 

require, providers to limit the measure of this objective to those patients whose records 

are maintained using CEHRT. 

Proposed Measure 1 To calculate the percentage, CMS and ONC have worked 

together to define the following for this measure: 
CMS-3310-P 88

Denominator: Number of medication orders created by the EP or authorized 

providers in the eligible hospital's or CAH's inpatient or emergency department (POS 21 

or 23) during the EHR reporting period. 

Numerator: The number of orders in the denominator recorded using CPOE. 

Threshold: The resulting percentage must be more than 80 percent in order for an 

EP, eligible hospital, or CAH to meet this measure. 

Exclusion: Any EP who writes fewer than 100 medication orders during the EHR 

reporting period. 

Proposed Measure 2 To calculate the percentage, CMS and ONC have worked 

together to define the following for this measure : 

Denominator: Number of laboratory orders created by the EP or authorized 

providers in the eligible hospital's or CAH's inpatient or emergency department (POS 21 

or 23) during the EHR reporting period. 

Numerator: The number of orders in the denominator recorded using CPOE. 

Threshold: The resulting percentage must be more than 60 percent in order for an 

EP, eligible hospital, or CAH to meet this measure. 

Exclusion: Any EP who writes fewer than 100 laboratory orders during the EHR 

reporting period. 

Proposed Measure 3 To calculate the percentage, CMS and ONC have worked 

together to define the following for this measure : 
CMS-3310-P 89

Denominator: Number of diagnostic imaging orders created by the EP or 

authorized providers in the eligible hospital's or CAH's inpatient or emergency 

department (POS 21 or 23) during the EHR reporting period. 

Numerator: The number of orders in the denominator recorded using CPOE. 

Threshold: The resulting percentage must be more than 60 percent in order for an 

EP, eligible hospital, or CAH to meet this measure. 

Exclusion: Any EP who writes fewer than 100 diagnostic imaging orders during 

the EHR reporting period.

We seek comment on if there are circumstances which might warrant an 

additional exclusion for an EP such as a situation representing a barrier to successfully 

implementing the technology required to meet the objective. We also seek comment on 

if there are circumstances where an eligible hospital or CAH which focuses on a 

particular patient population or specialty may have an EHR reporting period where the 

calculation results in a zero denominator for one of the measures, how often such 

circumstances might occur, and whether an exclusion would be appropriate. 

An EP through a combination of meeting the thresholds and exclusions must 

satisfy all three measures for this objective. An eligible hospital or CAH must meet the 

thresholds for all three measures. 

We welcome public comment on these proposals. 

Objective 5: Patient Electronic Access to Health Information

The Stage 1 and Stage 2 final rules included a number of objectives focused on 

increasing patient access to health information and supporting provider and patient 
CMS-3310-P 90

communication. These objectives include patient reminders (77 FR 54005 through 

54007), patient-specific education resources (77 FR 54011 through 54012), clinical 

summaries of office visits (77 FR 53998 through 54002), secure messaging (77 FR 54031 

through 54033), and the ability for patients to view, download, and transmit their health 

information to a third party (77 FR 54007 through 54011). For Stage 3, we generally 

identified two related policy goals within the overall larger goal of improved patient 

access to health information and patient-centered communication. The first is to ensure 

patients have timely access to their full health record and related important health 

information; and the second is to engage in patient-centered communication for care 

planning and care coordination. While these two goals are intricately linked, we see them 

as two distinct priorities requiring different foci and measures of success. For the first 

goal, we are proposing to incorporate the Stage 2 objectives related to providing patients 

with access to health information, including the objective for providing access for 

patients (or their authorized representatives) to view online, download, and transmit their 

health information and the objective for patient-specific education resources, into a new 

Stage 3 objective entitled, "Patient Electronic Access" (Objective 5), focused on using 

certified EHR technology to support increasing patient access to important health 

information. For the second goal, we are proposing an objective entitled Coordination of 

Care through Patient Engagement (Objective 6) incorporating the policy goals of the 

Stage 2 objectives related to secure messaging, patient reminders, and the ability for 

patients (or their authorized representatives) to view online, download, and transmit their 

health information using the functionality of the certified EHR technology. 
CMS-3310-P 91

In this Stage 3 Patient Electronic Access Objective, we are proposing to 

incorporate certain measures and objectives from Stage 2 into a single objective focused 

on providing patients with timely access to information related to their care. This 

proposed objective is a consolidation of the first measure of the Stage 2 Core Objective 

for EPs of "Provide patients the ability to view online, download, and transmit their 

health information within 4 business days of the information being available to the EP"

and the Stage 2 Core Objective for EPs to "Use clinically relevant information from 

CEHRT to identify patient-specific education resources and provide those resources to 

the patient." For eligible hospitals and CAHs, this proposed objective consolidates the 

first measure of the Stage 2 Core Objective for eligible hospitals/CAHs of "Provide 

patients the ability to view online, download, and transmit information about a hospital 

admission" and the Stage 2 Core Objective "Use clinically relevant information from 

CEHRT to identify patient-specific education resources and provide those resources to 

the patient." For further discussion around the development of the Stage 2 objectives, we 

direct readers to the Stage 2 final rule at (77 FR 53973).

In Stage 2, there are objectives that allow providers to communicate and provide 

information to patients through paper-based means, such as clinical summaries of office 

visits and patient-specific education resources. Although these methods of 

communication and information exchange are embraced by many providers and patients 

and we continue to support their use, we will no longer require or allow providers to 

capture and calculate these actions or attest to these measures for meaningful use Stage 3. 

While we believe that providing patients access to health information in many formats is 
CMS-3310-P 92

beneficial to patient-centered communication, care delivery, and quality improvement, 

meaningful use Stage 3 focuses exclusively on electronic, certified EHR technology 

supported communication.

We are also proposing to expand the options through which providers may engage 

with patients under the EHR Incentive Programs. Specifically, we are proposing an 

additional functionality, known as application-program interfaces (APIs), which would 

allow providers to enable new functionalities to support data access and patient exchange. 

An API is a set of programming protocols established for multiple purposes. APIs may 

be enabled by a provider or provider organization to provide the patient with access to 

their health information through a third-party application with more flexibility than often 

found in many current "patient portals." From the provider perspective, using this option 

would mean the provider would not be required to separately purchase or implement a 

"patient portal," nor would they need to implement or purchase a separate mechanism to 

provide the secure download and transmit functions for their patients because the API 

would provide the patient the ability to download or transmit their health information to a 

third party. If the provider elects to implement an API, the provider would only need to 

fully enable the API functionality, provide patients with detailed instructions on how to 

authenticate, and provide supplemental information on available applications which 

leverage the API. For further discussion on the technical requirements for APIs, we 

direct readers to the 2015 Edition proposed rule published elsewhere in this issue of the 

Federal Register. The certification criteria proposed by ONC would establish API 

criteria which would allow patients, through a third-party application, to pull certain
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components of their unique health data directly from the provider's CEHRT, and 

potentially could—on demand—pull such information from multiple providers caring for 

a patient. Therefore, we are proposing for the Patient Electronic Access objective to 

allow providers to enable API functionality in accordance with the proposed ONC 

requirements in the 2015 Edition proposed rule published elsewhere in this issue of the 

Federal Register. 

From the patient perspective, an API enabled by a provider will empower the 

patient to receive information from their provider in the manner that is most valuable to 

that particular patient. Patients would be able to collect their health information from 

multiple providers and potentially incorporate all of their health information into a single 

portal, application, program, or other software. We also believe that provider-enabled 

APIs allow patients to control the manner in which they receive their health information 

while still ensuring the interoperability of data across platforms. In addition, we 

recognize that a large number of patients consult with and rely on trusted family members 

and other caregivers to help coordinate care, understand health information, and make 

decisions. Therefore, we encourage providers to provide access to health information to 

appropriately authorized patient representatives.

As some low-cost and free API functions already exist in the health IT industry, 

we expect third-party application developers to continue to create low-cost solutions that 

leverage APIs as part of their business models. Therefore, we encourage health IT 

system developers to leverage these existing API platforms and applications to allow 

providers no-cost, or low-cost solutions to implement and enable an API as part of their 
CMS-3310-P 94

CEHRT systems. In addition, we do not believe it would be appropriate for EPs and 

hospitals to charge patients a fee for accessing their information using an API. 

The goal of this objective is to allow patients easy access to their health 

information as soon as possible, so that they can make informed decisions regarding their 

care and share their most recent clinical information with other health care providers and 

personal caregivers as they see fit. We believe this is also integral to the hospital

Partnership for Patients initiative and reducing hospital readmissions. This objective 

aligns with the Fair Information Practice Principles (FIPPS)9,in affording baseline 

privacy protections to individuals.10 

We seek comment on what additional requirements might be needed to ensure 

that if the eligible hospital, CAH or EP selects the API option-- (1) the functionality 

supports a patient's right to have his or her protected health information sent directly to a 

third party designated by the patient; and (2) patients have at least the same access to and 

use of their health information that they have under the view, download, and transmit 

option.

Proposed Objective: The EP, eligible hospital, or CAH provides access for patients to 

view online, download, and transmit their health information, or retrieve their health 

information through an API, within 24 hours of its availability.

 

9

1 In 1973, the Department of Health, Education, and Welfare (HEW) released its report, Records, Computers, and the Rights of 

Citizens, which outlined a Code of Fair Information Practices that would create ''safeguard requirements'' for certain ''automated 

personal data systems'' maintained by the Federal Government. This Code of Fair Information Practices is now commonly referred to 

as fair information practice principles (FIPPs) and established the framework on which much privacy policy would be built. There are 

many versions of the FIPPs; the principles described here are discussed in more detail in The Nationwide Privacy and Security 

Framework for Electronic Exchange of Individually Identifiable Health Information, December 15, 2008. 

http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov_privacy_security_framework/1173. 

10 The FIPPs, developed in the United States nearly 40 years ago, are well-established and have been incorporated into both the 

privacy laws of many states with regard to government-held records 2 and numerous international frameworks, including the 

development of the OECD's privacy guidelines, the European Union Data Protection Directive, and the Asia-Pacific Economic 

Cooperation (APEC) Privacy Framework. 

http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov_privacy_security_framework/1173. 
CMS-3310-P 95

We continue to believe that patient access to their electronic health information is 

a high priority for the EHR Incentive Programs. Furthermore, providing educational 

resources about a patient's health including recommendations for preventative care and 

screenings, identifying risk factors, and other important health resources can help to 

increase patient health literacy, empower patients to make more informed decisions, and 

support the efforts of providers in managing a patient care plan. We also believe that 

patient access to health information should be provided in the manner requested by the 

patient when possible. 

We note that for this objective, the provider is only required to provide access to 

the information through these means; the patient is not required to take action in order for 

the provider to meet this objective. In the Patient Electronic Access to Health 

Information objective, we note that "provides access" means that the patient has all the 

tools they need to gain access to their health information including any necessary 

instructions, user identification information, or the steps required to access their 

information if they have previously elected to "opt-out" of electronic access. If this 

information is provided to the patient in a clear and actionable manner, the provider may 

count the patient for this objective. Additionally, this objective should not require the 

provider to make extraordinary efforts to assist patients in use or access of the 

information, but the provider must inform patients of these options, and provide sufficient 

guidance so that all patients could leverage this access. The providers may withhold 

from online disclosure any information either prohibited by federal, state, or local laws or 

if such information provided through online means may result in significant harm. We 
CMS-3310-P 96

also note, as we have previously, that this is a meaningful use requirement, which does 

not affect an individual's right under HIPAA to access his or her health information. 

Providers must continue to comply with all applicable requirements under the HIPAA 

Privacy Rule, including the access provisions of 45 CFR 164.524.

Proposed Measures: EPs, eligible hospitals, and CAHs must satisfy both measures in 

order to meet the objective:

Proposed Measure 1: For more than 80 percent of all unique patients seen by 

the EP or discharged from the eligible hospital or CAH inpatient or emergency 

department (POS 21 or 23):

(1) The patient (or patient-authorized representative) is provided access to view 

online, download, and transmit their health information within 24 hours of its availability 

to the provider; or 

(2) The patient (or patient-authorized representative) is provided access to an 

ONC-certified API that can be used by third-party applications or devices to provide 

patients (or patient-authorized representatives) access to their health information, within 

24 hours of its availability to the provider.

Proposed Measure 2: The EP, eligible hospital or CAH must use clinically 

relevant information from CEHRT to identify patient-specific educational resources and 

provide electronic access to those materials to more than 35 percent of unique patients 

seen by the EP or discharged from the eligible hospital or CAH inpatient or emergency 

department (POS 21 or 23) during the EHR reporting period. 

We propose that for measure 1, the patient must be able to access this information 
CMS-3310-P 97

on demand, such as through a patient portal, personal health record (PHR), or API and 

have everything necessary to access the information even if they opt out. All three 

functionalities (view, download, and transmit) or an API must be present and accessible 

to meet the measure. The functionality must support a patient's right to have his or her 

protected health information sent directly to a third party designated by the patient 

consistent with the provision of access requirements at 45 CFR 164.524(c) of the HIPAA 

Privacy Rule.

However, if the provider can demonstrate that at least one application that 

leverages the API is available (preferably at no cost to the patient) and that more than 

80 percent of all unique patients have been provided instructions on how to access the 

information; the provider need not create, purchase, or implement redundant software to 

enable view, download, and transmit capability independently of the API. 

We propose to increase the threshold for measure 1 from the Stage 1 and Stage 2 

threshold of 50 percent to a threshold of 80 percent for Stage 3. We believe that all 

patients should be provided access to their electronic health record; however, we are 

setting the threshold at 80 percent based on the highest threshold defined for measures 

based on unique patients seen by the provider during the EHR reporting period in the 

Stage 2 final rule (for example see 77 FR 53993). Based on the continued progress 

toward automation and standardization of data capture supported by CEHRT which 

facilitates a faster response time, we further propose to decrease patient wait time for the 

availability of information to within 24 hours of the office visit or of the information 
CMS-3310-P 98

becoming available to the provider for potential inclusion in the case of lab or other test 

results which require sufficient time for processing and returning results. 

For measure 2, we propose to increase the threshold that was finalized in Stage 2 

from 10 percent to 35 percent. We believe that the 35 percent threshold both ensures that 

providers are using CEHRT to identify patient-specific education resources and is low 

enough to not infringe on the provider's freedom to choose education resources and to 

which patients these resources will be provided. 

We continue to propose that both measures for this objective must be met using 

CEHRT. For the purposes of meeting this objective, this would mean the capabilities 

provided by a patient portal, PHR, or any other means of online access that would permit 

a patient or authorized representatives to view, download, and transmit their personal 

health information and/or any API enabled, must be certified in accordance with the 

certification requirements adopted by ONC. 

We are proposing a continuation of the exclusion in Stage 2 for both EPs and 

eligible hospitals/CAHs in that any EP, eligible hospital, or CAH would be excluded 

from the first measure if it is located in a county that does not have 50 percent or more of 

their housing units with 4Mbps broadband availability according to the latest information 

available from the FCC at the start of the EHR reporting period. We continue to 

recognize that in areas of the country where a significant section of the patient population 

does not have access to broadband internet, this measure may be significantly harder or 

impossible to achieve. Finally, we propose an additional exclusion for EPs for Stage 3, 

that any EP who has no office visits during the EHR reporting period may be excluded 
CMS-3310-P 99

from the measures. We encourage comments on these exclusions and will evaluate them 

again in light of the public comments received. 

Proposed Measure 1: To calculate the percentage, CMS and ONC have worked 

together to define the following for this measure: 

Denominator: The number of unique patients seen by the EP or the number of 

unique patients discharged from an eligible hospital or CAH inpatient or emergency 

department (POS 21 or 23) during the EHR reporting period. 

Numerator: The number of patients in the denominator who are provided access 

to information within 24 hours of its availability to the EP or eligible hospital/CAH. 

Threshold: The resulting percentage must be more than 80 percent in order for a 

provider to meet this measure. 

Exclusions: An EP may exclude from the measure if they have no office visits 

during the EHR reporting period. 

Any EP that conducts 50 percent or more of his or her patient encounters in a 

county that does not have 50 percent or more of its housing units with 4Mbps broadband 

availability according to the latest information available from the FCC on the first day of 

the EHR reporting period may exclude the measure.

Any eligible hospital or CAH will be excluded from the measure if it is located in 

a county that does not have 50 percent or more of their housing units with 4Mbps 

broadband availability according to the latest information available from the FCC at the 

start of the EHR reporting period.
CMS-3310-P 100

Proposed Measure 2: To calculate the percentage, CMS and ONC have worked 

together to define the following for this measure: 

Denominator: The number of unique patients seen by the EP or the number of 

unique patients discharged from an eligible hospital or CAH inpatient or emergency 

department (POS 21 or 23) during the EHR reporting period. 

Numerator: The number of patients in the denominator who were provided 

electronic access to patient-specific educational resources using clinically relevant 

information identified from CEHRT. 

Threshold: The resulting percentage must be more than 35 percent in order for a 

provider to meet this measure. 

Exclusions: An EP may exclude from the measure if they have no office visits 

during the EHR reporting period. 

Any EP that conducts 50 percent or more of his or her patient encounters in a 

county that does not have 50 percent or more of its housing units with 4Mbps broadband 

availability according to the latest information available from the FCC on the first day of 

the EHR reporting period may exclude the measure.

Any eligible hospital or CAH will be excluded from the measure if it is located in 

a county that does not have 50 percent or more of their housing units with 4Mbps 

broadband availability according to the latest information available from the FCC at the 

start of the EHR reporting period. 

Alternate Proposals: 

We note that for measure one we are seeking comment on the following set of 
CMS-3310-P 101

alternate proposals for providers to meet the measure using the functions of CEHRT 

outlined previously in this section. These alternate proposals involve the requirements to 

use a view, download, and transmit function or an API to provide patients access to their 

health information. We believe the current view, download, and transmit functions are 

widely in use and represent the current standard for patient access to their health record. 

However, we believe that the use of APIs could potentially replace this function and 

move toward a more accessible means for patients to access their information. Therefore, 

we are seeking comment on alternatives which would present a different mix of CEHRT 

functionality for providers to use for patients seeking to access their records. The 

proposed first measure discussed previously would allow providers the option either to 

give patients access to the view, download, and transmit functionality, or to give patients 

access to an API. Specifically, we are seeking comment on whether the API option 

should be required rather than optional for providers, and if so, should providers also be 

required to offer the view, download, and transmit function. 

Proposed Measure 1: For more than 80 percent of all unique patients seen by 

the EP or discharged from the eligible hospital or CAH inpatient or emergency 

department (POS 21 or 23):

(1) The patient (or patient-authorized representative) is provided access to view 

online, download, and transmit their health information within 24 hours of its availability 

to the provider; or

(2) The patient (or the patient-authorized representative) is provided access to an 

ONC-certified API that can be used by third-party applications or devices to provide 
CMS-3310-P 102

patients (or patient authorized representatives) access to their health information, within 

24 hours of its availability to the provider.

Alternate A: For more than 80 percent of all unique patients seen by the EP or 

discharged from the eligible hospital or CAH inpatient or emergency department (POS 21 

or 23):

(1) The patient (or the patient-authorized representative) is provided access to 

view online, download, and transmit his or her health information within 24 hours of its 

availability to the provider; and

(2) The patient (or patient-authorized representatives) is provided access to an 

ONC-certified API that can be used by third-party applications or devices to provide 

patients (or patient authorized representatives) access to their health information within 

24 hours of its availability to the provider.

Alternate B: For more than 80 percent of all unique patients seen by the EP or 

discharged from the eligible hospital or CAH inpatient or emergency department (POS 21 

or 23):

(1) The patient (or patient-authorized representative) is provided access to view 

online, download, and transmit their health information within 24 hours of its availability 

to the provider; and the patient (or patient-authorized representative) is provided access 

to an ONC-certified API that can be used by third-party applications or devices to 

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

within 24 hours of its availability to the provider; or,

(2) The patient (or patient-authorized representatives) is provided access to an 
CMS-3310-P 103

ONC-certified API that can be used by third-party applications or devices to provide 

patients (or patient authorized representatives) access to their health information within 

24 hours of its availability to the provider.

Alternate C: For more than 80 percent of all unique patients seen by the EP or 

discharged from the eligible hospital or CAH inpatient or emergency department (POS 21 

or 23), the patient (or patient-authorized representative) is provided access to an 

ONC-certified API that can be used by third-party applications or devices to provide 

patients (or patient-authorized representatives) access to their health information, within 

24 hours of its availability to the provider.

These three alternate proposals would represent different use cases for the 

CEHRT function to support view, download, and transmit and/or API functionality. We 

note that under these proposed alternates the following mix of functions would be 

applicable: Alternate A would require both functions to be available instead of allowing 

the provider to choose between the two; Alternate B would require the provider to choose 

to have either both functions, or just an API function; and Alternate C would require the 

provider to only have the API function. For Alternate C, the use of a separate view, 

download, and transmit function would be entirely at the provider's discretion and not 

included as part of the definition of meaningful use. 

We welcome public comment on these proposals. 

Objective 6: Coordination of Care through Patient Engagement

As mentioned previously, the Stage 1 and Stage 2 final rules included a number of 

objectives focused on patient access to health information and communication among 
CMS-3310-P 104

providers, care teams, and patients. These patient engagement objectives focused on 

changing behaviors among providers and patients to promote patient involvement in 

health care. Specifically, the objectives included supporting provider and patient 

communication about their health, improving overall patient health literacy, and 

supporting patient-driven coordination with providers and other members of the patient's 

care team. The Stage 1 and Stage 2 objectives included patient reminders (77 FR 54005 

through 54007), patient-specific education resources (77 FR 54011 through 54012), 

clinical summaries of office visits (77 FR 53998 through 54002), secure messaging 

(77 FR 54031 through 54033), and the ability for patients to view, download, and 

transmit their health information to a third party (77 FR 54007 through 54011). For 

Stage 3, as mentioned previously, we are proposing to incorporate the Stage 2 objectives 

related to providing patients with access to health information into a new Stage 3 

objective entitled, "Patient Electronic Access" (Objective 5). For the proposed objective 

entitled Coordination of Care through Patient Engagement (Objective 6), we are 

proposing to incorporate the policy goals of the Stage 2 objectives related to secure 

messaging, patient reminders, and the measure of patient engagement requiring patients 

(or their authorized representatives) to view, download, and transmit their health 

information using the functionality of the certified EHR technology. 

As mentioned previously, while we believe there may be many methods of 

communication and information sharing among providers, or other care team members, 

and patients (including paper-based or telephone communications), meaningful use 

Stage 3 focuses exclusively on electronic, certified EHR technology supported 
CMS-3310-P 105

communication in the requirements outlined in this proposed objective for Coordination 

of Care through Patient Engagement. 

Proposed Objective: Use communications functions of certified EHR technology to 

engage with patients or their authorized representatives about the patient's care. 

Specifically, this proposed rule focuses on encouraging the use of EHR 

functionality for secure dialogue and efficient communication between providers, care 

team members, and patients about their care and health status, as well as important health 

information such as preventative and coordinated care planning. In addition, certified 

EHR technology functions designed to support patient engagement can be a platform to 

securely capture and record patient-generated health data and information provided in 

non-clinical care settings. 

We are also proposing to expand the options through which providers may engage 

with patients under the EHR Incentive Programs including the use of APIs as mentioned 

previously. An API can enable a patient—through a third-party application—to access 

and retrieve their health information from a care provider in a way that is most valuable 

to that particular patient. 

Therefore, we are proposing a meaningful use objective for Stage 3 to support this 

provider and patient engagement continuum based on the foundation already created 

within the EHR Incentive Programs but using new methods and expanded options to 

advance meaningful patient engagement and patient-centered care. We also propose that 

for purposes of this objective, patient engagement may include patient-centered 

communication between and among providers facilitated by authorized representatives of 
CMS-3310-P 106

the patient and of the EP, eligible hospital, or CAH. As care delivery evolves, the 

participation of a diverse group of care team members enables more robust care for the 

patient. Engagement between the patient and, for example, nutritionists, social workers, 

physical therapists, or other members of the provider's care team is crucial to effective 

patient engagement and are therefore included in this objective. 

For Stage 3 of meaningful use, we propose the following measures for the Patient 

Engagement Objective: 

Proposed Measures: We are proposing that providers must attest to the numerator and 

denominator for all three measures, but would only be required to successfully meet the 

threshold for two of the three proposed measures to meet the Coordination of Care 

through Patient Engagement Objective. These three measures support the 

communication continuum between providers, patients, and the patient's authorized 

representatives through the use of view, download, and transmit functionality. They also 

support using API functionality through patient engagement with their health data, but 

also potentially through secure messaging functions and standards, and the capture and 

inclusion of data collected from non-clinical settings, including patient-generated health 

data. 

Proposed Measure 1: During the EHR reporting period, more than 25 percent of 

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

inpatient or emergency department (POS 21 or 23) actively engage with the electronic 

health record made accessible by the provider. An EP, eligible hospital or CAH may 

meet the measure by either: 
CMS-3310-P 107

(1) More than 25 percent of all unique patients (or patient-authorized 

representatives) seen by the EP or discharged from the eligible hospital or CAH inpatient 

or emergency department (POS 21 or 23) during the EHR reporting period view, 

download or transmit to a third party their health information; or

(2) More than 25 percent of all unique patients (or patient-authorized 

representatives) seen by the EP or discharged from the eligible hospital or CAH inpatient 

or emergency department (POS 21 or 23) during the EHR reporting period access their 

health information through the use of an ONC-certified API that can be used by 

third-party applications or devices.

Proposed Measure 2: For more than 35 percent of all unique patients seen by 

the EP or discharged from the eligible hospital or CAH inpatient or emergency 

department (POS 21 or 23) during the EHR reporting period, a secure message was sent 

using the electronic messaging function of CEHRT to the patient (or the patient's

authorized representatives), or in response to a secure message sent by the patient (or the 

patient's authorized representative).

Proposed Measure 3: Patient-generated health data or data from a non-clinical 

setting is incorporated into the certified EHR technology for more than 15 percent of all 

unique patients seen by the EP or discharged by the eligible hospital or CAH inpatient or 

emergency department (POS 21 or 23) during the EHR reporting period.

For measure 1, we are proposing to increase the threshold for the measure from 

5 percent to 25 percent based on provider performance on the related Stage 2 measure 

requiring more than 5 percent of patients to view, download, or transmit to a third party 
CMS-3310-P 108

the health information made available to them by the provider. Stage 2 median 

performance for an EP on this measure is 32 percent and 11 percent for eligible 

hospitals.11 Therefore, we are proposing more than 25 percent of all unique patients (or 

the patient's authorized representatives) seen by the EP, eligible hospital or CAH during 

the EHR reporting period must view, download, or transmit to a third party their health 

information or access their health information through the use of an ONC-certified API 

that can be used by third-party applications or devices. For the API option, we propose 

that providers must attest that they have enabled an API and that at least one application 

which leverages the API is available to patients (or the patient-authorized representatives) 

to retrieve health information from the provider's certified EHR.

CMS recognizes that there may be inherent challenges in measuring patient 

access to CEHRT through third-party applications that utilize an ONC-certified API, and 

we solicit comment on the nature of those challenges and what solutions can be put in 

place to overcome them. For example, are there specific requirements around the use of 

APIs or are there specific certification requirements for APIs that could make the 

measurement of this objective easier. We also solicit comment on suggested alternate 

proposals for measuring patient access to CEHRT through third-party applications that 

utilize an API, including the pros and cons of measuring a minimum number of patients 

(one or more) who must access their health information through the use of an API in 

order to meet the measure of this objective. 

For measure 2, the EP, eligible hospital, CAH, or the provider's authorized 

 

11 Data can be found on CMS website Data and Program Reports page: https://www.cms.gov/Regulations-andGuidance/Legislation/EHRIncentivePrograms/DataAndReports.html
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representative must communicate with the patient (or the patient's authorized 

representatives), through secure electronic messaging for more than 35 percent of the 

unique patients seen by the provider during the EHR reporting period. "Communicate"

means when a provider sends a message to a patient (or the patient's authorized 

representatives) or when a patient (or the patient's authorized representatives) sends a 

message to the provider. In patient-to-provider communication, the provider must 

respond to the patient (or the patient's authorized representatives) for purposes of this 

measure. We propose to increase the threshold for this measure over the threshold for the 

Stage 2 measure because for Stage 3 provider initiated messages would count toward the 

measure numerator. 

For measure 2, we propose to include in the measure numerator situations where 

providers communicate with other care team members using the secure messaging 

function of certified EHR technology, and the patient is engaged in the message and has 

the ability to be an active participant in the conversation between care providers. 

However, we seek comment on how this action could be counted in the numerator, and 

the extent to which that interaction could or should be counted for eligible providers 

engaged in the communication. For example, should only the initiating provider be 

allowed to include the communication as an action in the numerator? Or, should any 

provider who contributes to such a message during the EHR reporting period be allowed 

to count the communication? In addition, we seek comment on what should be 

considered a contribution to the patient-centered communication; for example, a 

contribution must be active participation or response, a contribution may be viewing the 
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communication, or a contribution may be simple inclusion in the communication.

We specify that the secure messages sent should contain relevant health 

information specific to the patient in order to meet the measure of this objective. We 

believe the provider is the best judge of what health information should be considered 

relevant in this context. For the purposes of this measure, we are proposing that secure 

messaging content may include, but is not limited to, questions about test results, 

problems, and medications; suggestions for follow-up care or preventative screenings; 

confirmations of diagnosis and care plan goals; and information regarding patient 

progress. However, we note that messages with content exclusively relating to billing 

questions, appointment scheduling, or other administrative subjects should not be 

included in the numerator. For care team secure messaging with the patient included in 

the conversation, we also believe the provider may exercise discretion if further 

communications resulting from the initial action should be excluded from patient 

disclosure to prevent harm. We note that if such a message is excluded, all subsequent 

actions related to that message would not count toward the numerator. 

For measure 3, EPs, eligible hospitals, and CAHs (or their authorized 

representatives) must incorporate health data obtained from a non-clinical setting in a 

patient's electronic health record for more than 15 percent of unique patients seen during 

the EHR reporting period. We note that the use of the term "clinical" means different 

things in relation to place of service for billing for Medicare and Medicaid services. 

However, for purposes of this measure only, we are proposing that a non-clinical setting 

shall be defined as a setting with any provider who is not an EP, eligible hospital or CAH 
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as defined for the Medicare and Medicaid EHR Incentive Programs. Therefore, for this 

measure, a non-clinical setting is any provider or setting of care which is not an EP, 

eligible hospital, or CAH in either the Medicare or Medicaid EHR Incentive Programs 

and where the care provider does not have shared access to the EP, eligible hospital, or 

CAHs certified EHR. This may include, but is not limited to, health and care-related data 

from care providers such as nutritionists, physical therapists, occupational therapists, 

psychologists, and home health care providers as well as data obtained from patients 

themselves. We specifically mention this last item and refer to this sub-category as 

patient-generated health data, which may result from patient self-monitoring of their 

health (such as recording vital signs, activity and exercise, medication intake, and 

nutrition), either on their own, or at the direction of a member of the care team. We are 

proposing this measure in response to requests from providers to support the capture and 

incorporation of patient-generated health data, and the capture and incorporation of data 

from a non-clinical setting into an EHR. Providers have expressed a desire to have this 

information captured in a useful and structured way and made available in the EHR. The 

capture and incorporation of this information is an integral part of ensuring that providers 

and patients have adequate information to partner in making clinical care decisions, 

especially for patients with chronic disease and complex health conditions for whom 

self-monitoring is an important part of an ongoing care plan. 

We are seeking comment on how the information for measure 3 could be 

captured, standardized, and incorporated into an EHR. For the purposes of this measure, 

the types of data that would satisfy the measure is broad. It may include, but is not 
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limited to social service data, data generated by a patient or a patient's authorized 

representatives, advance directives, medical device data, home health monitoring data, 

and fitness monitor data. In addition, the sources of data vary and may include mobile 

applications for tracking health and nutrition, home health devices with tracking 

capabilities such as scales and blood pressure monitors, wearable devices such as activity 

trackers or heart monitors, patient reported outcome data, and other methods of input for 

patient and non-clinical setting generated health data. We emphasize that these represent 

several examples of the data types that could be covered under this measure. We also 

note that while the scope of data covered by this measure is broad, it may not include data 

related to billing, payment, or other insurance information. As part of determining the 

proper scope of this measure, we are seeking comment on the following questions: 

 Should the data require verification by an authorized provider?

 Should the incorporation of the data be automated?

 Should there be structured data elements available for this data as fields in an 

EHR?

 Should the data be incorporated in the CEHRT with or without provider 

verification?

 Should the provenance of the data be recorded in all cases and for all types of 

data?

We also seek comment on whether this proposed measure should have a 

denominator limited to patients with whom the provider has multiple encounters, such as 

unique patients seen by the provider two or more times during the EHR reporting period. 
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We also seek comment on whether this measure should be divided into two distinct 

measures. The first measure would include only the specific sub-category of 

patient-generated health data, or data generated predominantly through patient 

self-monitoring rather than by a provider. The second measure would include all other 

data from a non-clinical setting. This would result in the objective including four 

measures with providers having an option of which two measures to focus on for the 

EHR reporting period. 

We also seek comment on whether the third measure should be proposed for 

eligible hospitals and CAHs, or remain an option only for eligible professionals. For 

those commenters who believe it should not be applicable for eligible hospitals and 

CAHs, we seek further comment on whether eligible hospitals and CAHs should then 

choose one of the remaining two measures or be required to attest to both. 

Providers must attest to the numerator and denominator for all three measures, 

and must meet the threshold for two of the three measures to meet the objective for 

Stage 3 of meaningful use:

Proposed Measure 1: We have identified the following for measure 1 of this 

objective:

Option 1: View, Download, or Transmit to a Third Party

Denominator: Number of unique patients seen by the EP, or the number of 

unique patients discharged from an eligible hospital or CAH inpatient or emergency 

department (POS 21 or 23) during the EHR reporting period.

Numerator: The number of unique patients (or their authorized representatives) in 
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the denominator who have viewed online, downloaded, or transmitted to a third party the 

patient's health information. 

Threshold: The resulting percentage must be more than 25 percent in order for an 

EP, eligible hospital, or CAH to meet this measure.

Option 2: API 

Denominator: The number of unique patients seen by the EP or the number of 

unique patients discharged from an eligible hospital or CAH inpatient or emergency 

department (POS 21 or 23) during the EHR reporting period. 

Numerator: The number of unique patients (or their authorized representatives) in 

the denominator who have accessed their health information through the use of an an 

ONC-certified API.

Threshold: The resulting percentage must be more than 25 percent in order for an 

EP, eligible hospital, or CAH to meet this measure. 

Exclusions: Applicable for either option discussed previously, the following 

providers may exclude from the measure:

Any EP who has no office visits during the EHR reporting period may exclude 

from the measure. 

Any EP that conducts 50 percent or more of his or her patient encounters in a 

county that does not have 50 percent or more of its housing units with 4Mbps broadband 

availability according to the latest information available from the FCC on the first day of 

the EHR reporting period may exclude from the measure.

Any eligible hospital or CAH operating in a location that does not have 50 percent 
CMS-3310-P 115

or more of its housing units with 4Mbps broadband availability according to the latest 

information available from the FCC on the first day of the EHR reporting period may 

exclude from the measure. 

Measure 2: 

Denominator: Number of unique patients seen by the EP or the number of unique 

patients discharged from an eligible hospital or CAH inpatient or emergency department 

(POS 21 or 23) during the EHR reporting period. 

Numerator: The number of patients in the denominator for whom a secure 

electronic message is sent to the patient, the patient's authorized representatives, or in 

response to a secure message sent by the patient.

Threshold: The resulting percentage must be more than 35 percent in order for an 

EP, eligible hospital, or CAH to meet this measure. 

Exclusion: Any EP who has no office visits during the EHR reporting period may 

exclude from the measure. 

Any EP that conducts 50 percent or more of his or her patient encounters in a 

county that does not have 50 percent or more of its housing units with 4Mbps broadband 

availability according to the latest information available from the FCC on the first day of 

the EHR reporting period may exclude from the measure.

Any eligible hospital or CAH operating in a location that does not have 50 percent 

or more of its housing units with 4Mbps broadband availability according to the latest 

information available from the FCC on the first day of the EHR reporting period may 

exclude from the measure. 
CMS-3310-P 116

Measure 3:

Denominator: Number of unique patients seen by the EP or the number of unique 

patients discharged from an eligible hospital or CAH inpatient or emergency department 

(POS 21 or 23) during the EHR reporting period.

Numerator: The number of patients in the denominator for whom data from 

non-clinical settings, which may include patient-generated health data, is captured 

through the certified EHR technology into the patient record. 

Threshold: The resulting percentage must be more than 15 percent in order for an 

EP, eligible hospital, or CAH to meet this measure. 

Exclusion: Any EP who has no office visits during the EHR reporting period may 

exclude from the measure. 

Any EP that conducts 50 percent or more of his or her patient encounters in a 

county that does not have 50 percent or more of its housing units with 4Mbps broadband 

availability according to the latest information available from the FCC on the first day of 

the EHR reporting period may exclude from the measure.

Any eligible hospital or CAH operating in a location that does not have 50 percent 

or more of its housing units with 4Mbps broadband availability according to the latest 

information available from the FCC on the first day of the EHR reporting period may 

exclude from the measure. 

We seek comment on this proposed objective and the related proposed measures.

Objective 7: Health Information Exchange
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Improved communication between providers caring for the same patient can help 

providers make more informed care decisions and coordinate the care they provide. 

Electronic health records and the electronic exchange of health information, either 

directly or through health information exchanges, can reduce the burden of such 

communication. The purpose of this objective is to ensure a summary of care record is 

transmitted or captured electronically and incorporated into the EHR for patients seeking 

care among different providers in the care continuum, and to encourage reconciliation of 

health information for the patient. This objective promotes interoperable systems and 

supports the use of CEHRT to share information among care teams.

Proposed Objective: The EP, eligible hospital, or CAH provides a summary of care 

record when transitioning or referring their patient to another setting of care, retrieves a 

summary of care record upon the first patient encounter with a new patient, and 

incorporates summary of care information from other providers into their EHR using the 

functions of certified EHR technology. 

In the Stage 2 final rule at 77 FR 53983, we described transitions of care as the 

movement of a patient from one setting of care (hospital, ambulatory primary care 

practice, ambulatory specialty care practice, long-term care, home health, rehabilitation 

facility) to another. Referrals are cases where one provider refers a patient to another 

provider, but the referring provider also continues to provide care to the patient. In this 

rule, we also recognize there may be circumstances when a patient refers himself or 

herself to a setting of care without a provider's prior knowledge or intervention. These 

referrals may be included as a subset of the existing referral framework and they are an 
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important part of the care coordination loop for which summary of care record exchange 

is integral. Therefore, a provider should include these instances in their denominator for 

the measures if the patient subsequently identifies the provider from whom they received 

care. In addition, the provider may count such a referral in the numerator for each 

measure if they undertake the action required to meet the measure upon disclosure and 

identification of the provider from whom the patient received care.

In the Stage 2 final rule, we indicated that a transition or referral within a single 

setting of care does not qualify as a transition of care (77 FR 53983). We received public 

comments and questions requesting clearer characterization of when a setting of care can 

be considered distinct from another setting of care. For example, questions arose whether 

EPs who work within the same provider practice are considered the same or two distinct 

settings of care. Similarly, questions arose whether an EP who practices in an outpatient 

setting that is affiliated with an inpatient facility is considered a separate entity. 

Therefore, for the purposes of distinguishing settings of care in determining the 

movement of a patient, we explain that for a transition or referral, it must take place 

between providers which have, at the minimum, different billing identities within the 

EHR Incentive Programs, such as a different National Provider Identifiers (NPI) or 

hospital CMS Certification Numbers (CCN) to count toward this objective. 

Please note that a "referral" as defined here and elsewhere in this proposed rule 

only applies to the EHR Incentive Programs and is not applicable to other federal 

regulations. 
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We stated in the Stage 2 proposed rule at 77 FR 13723 that if the receiving 

provider has access to the medical record maintained by the provider initiating the 

transition or referral, then the summary of care record would not need to be provided and 

that patient may be excluded from the denominators of the measures for the objective. 

We further note that this access may vary from read-only access of a specific record, to 

full access with authoring capabilities, depending on provider agreements and system 

implementation among practice settings. In many cases, a clinical care summary for 

transfers within organizations sharing access to an EHR may not be necessary, such as a 

hospital sharing their CEHRT with affiliated providers in ambulatory settings who have 

full access to the patient information. However, public comments received and questions 

submitted by the public on the Stage 2 Summary of Care Objective reveal that there may 

be benefits to the provision of a summary of care document following a transition or 

referral of a patient, even when access to medical records is already available. For 

example, a summary of care document would notify the receiving provider of relevant 

information about the latest patient encounter as well as highlight the most up-to-date 

information. In addition, the "push" of a summary of care document may function as an 

alert to the recipient provider of the transition that a patient has received care elsewhere 

and would encourage the provider to review a patient's medical record for follow-up care 

or reconciliation of clinical information. 

Therefore, we are revising this objective for Stage 3 to allow the inclusion of 

transitions of care and referrals in which the recipient provider may already have access 

to the medical record maintained in the referring provider's CEHRT, as long as the 
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providers have different billing identities within the EHR Incentive Program. We note 

that for a transition or referral to be included in the numerator, if the receiving provider 

already has access to the CEHRT of the initiating provider of the transition or referral, 

simply accessing the patient's health information does not count toward meeting this 

objective. However, if the initiating provider also sends a summary of care document, 

this transition can be included in the denominator and the numerator, as long as this 

transition is counted consistently across the organization.

Proposed Measures: We are proposing that providers must attest to the numerator 

and denominator for all three measures, but would only be required to successfully meet 

the threshold for two of the three proposed measures to meet the Health Information 

Exchange Objective.

Proposed Measure 1: For more than 50 percent of transitions of care and 

referrals, the EP, eligible hospital or CAH that transitions or refers their patient to another 

setting of care or provider of care: (1) creates a summary of care record using CEHRT;

and (2) electronically exchanges the summary of care record. 

Proposed Measure 2: For more than 40 percent of transitions or referrals 

received and patient encounters in which the provider has never before encountered the 

patient, the EP, eligible hospital or CAH incorporates into the patient's EHR an electronic 

summary of care document from a source other than the provider's EHR system. 

Proposed Measure 3: For more than 80 percent of transitions or referrals 

received and patient encounters in which the provider has never before encountered the 

patient, the EP, eligible hospital, or CAH performs a clinical information reconciliation. 
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The provider must implement clinical information reconciliation for the following 

three clinical information sets: 

 Medication. Review of the patient's medication, including the name, dosage, 

frequency, and route of each medication.

 Medication allergy. Review of the patient's known allergic medications.

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

For the first measure, we are maintaining the requirements established in the 

Stage 2 final rule to capture structured data within the certified EHR and to generate a 

summary of care document using CEHRT for purposes of this measure (77 FR 54014). 

For purposes of this measure, we are requiring that the summary of care document 

created by CEHRT be sent electronically to the receiving provider.

In the Stage 2 final rule at 77 FR 54016, we specified all summary of care 

documents must include the following information in order to meet the objective, if the 

provider knows it: 

● Patient name.

● Referring or transitioning provider's name and office contact information 

(EP only).

● Procedures.

● Encounter diagnosis.

● Immunizations.

● Laboratory test results.

● Vital signs (height, weight, blood pressure, BMI).
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● Smoking status.

● Functional status, including activities of daily living, cognitive and disability 

status.

● Demographic information (preferred language, sex, race, ethnicity, date of 

birth).

● Care plan field, including goals and instructions.

● Care team including the primary care provider of record and any additional 

known care team members beyond the referring or transitioning provider and the 

receiving provider.

● Discharge instructions (Hospital Only).

● Reason for referral (EP only).

For the 2015 Edition proposed rule, ONC has proposed a set of criteria called the 

Common Clinical Data Set which include the required elements for the summary of care 

document, the standards required for structured data capture of each, and further 

definition of related terminology and use. Therefore, for Stage 3 of meaningful use we 

are proposing that summary of care documents used to meet the Stage 3 Health 

Information Exchange objective must include the requirements and specifications 

included in the Common Clinical Data Set (CCDS) specified by ONC for certification to 

the 2015 Edition proposed rule published elsewhere in this issue of the Federal Register.

We note that ONC's 2015 Edition proposed rule may include additional fields 

beyond those initially required for Stage 2 of meaningful use as new standards have been 

developed to accurately capture vital information on patient health. For example, the 
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2015 Edition proposed rule includes a criterion and standard for capturing the unique 

device identifier (UDI) for implantable medical devices. The inclusion of the UDI in the 

CCDS reflects the understanding that UDIs are an important part of patient information 

that should be exchanged and available to providers who care for patients with implanted 

medical devices. Hundreds of thousands of Medicare beneficiaries receive some type of 

implantable medical device each year. Some implants require ongoing monitoring and 

medication for the device to perform effectively, such as a mechanical heart valve. Other 

implanted devices are affected by imaging procedures and are not MRI safe such as some 

pace makers. Even the variation between specific makes and models of similar devices 

may impact the clinical processes required to mitigate against patient safety risk. 

Without readily available data, the patient is put at risk if the provider does not have 

adequate knowledge of the existence and specific details of medical implants. Therefore, 

the documentation of UDIs in a patient medical record and the inclusion of that data field 

within the CCDS requirements for the summary of care documents is a key step toward 

improving the quality of care and ensuring patient safety. This example highlights the 

importance of capturing health data in a structured format using specified, transferable 

standards. 

In circumstances where there is no information available to populate one or more 

of the fields included in the CCDS, either because the EP, eligible hospital, or CAH can 

be excluded from recording such information (for example, vital signs) or because there 

is no information to record (for example, laboratory tests), the EP, eligible hospital, or 

CAH may leave the field blank and still meet the requirements for the measure. 
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However, all summary of care documents used to meet this objective must be 

populated with the following information using the CCDS certification standards for 

those fields: 

 Current problem list (Providers may also include historical problems at their

discretion).

 A current medication list.

 A current medication allergy list. 

We define allergy as an exaggerated immune response or reaction to substances 

that are generally not harmful. Information on problems, medications, and medication 

allergies could be obtained from previous records, transfer of information from other 

providers (directly or indirectly), diagnoses made by the EP or hospital, new medications 

ordered by the EP or in the hospital, or through querying the patient. 

We propose to maintain that all summary of care documents contain the most 

recent and up-to-date information on all elements. In the event that there are no current 

diagnoses for a patient, the patient is not currently taking any medications, or the patient 

has no known medication allergies; the EP, eligible hospital, or CAH must record or 

document within the required fields that there are no problems, no medications, or no 

medication allergies recorded for the patient to satisfy the measure of this objective. The 

EP or hospital must verify that the fields for problem list, medication list, and medication 

allergy list are not blank and include the most recent information known by the EP or 

hospital as of the time of generating the summary of care document. 
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For summary of care documents at transitions of care, we encourage providers to 

send a list of items that he or she believes to be pertinent and relevant to the patient's 

care, rather than a list of all problems, whether active or resolved, that have ever 

populated the problem list. While a current problem list must always be included, the 

provider can use his or her judgment in deciding which items historically present on the 

problem list, medical history list (if it exists in CEHRT), or surgical history list are 

relevant given the clinical circumstances. 

Similarly, for Stage 3 we have received comments from stakeholders and through 

public forums and correspondence on the potential of allowing only clinically relevant 

laboratory test results and clinical notes (rather than all laboratory tests results and 

clinical notes) in the summary of care document for purposes of meeting the objective. 

We believe that while there may be a benefit and efficiency to be gained in the potential 

to limit laboratory test results or clinical notes to those most relevant for a patient's care; 

a single definition of clinical relevance may not be appropriate for all providers, all 

settings, or all individual patient diagnosis. Furthermore, we note that should a 

reasonable limitation around a concept of "clinical relevance" be added; a provider must 

still have the CEHRT functionality to include and send all labs or clinical notes. 

Therefore, we defer to provider discretion on the circumstances and cases wherein a 

limitation around clinical relevance may be beneficial and note that such a limitation 

would be incumbent on the provider to define and develop in partnership with their health 

IT developer as best fits their organizational needs and patient population. We specify 

that while the provider has the discretion to define the relevant clinical notes or relevant 
CMS-3310-P 126

laboratory results to send as part of the summary of care record, providers must be able to 

provide all clinical notes or laboratory results through an electronic transmission of a 

summary of care document if that level of detail is subsequently requested by a provider 

receiving a transition of care or referral or the patient is transitioning to another setting of 

care. We note that this proposal would apply for lab results, clinical notes, problem lists, 

and the care plan within the summary of care document. 

For the second measure, we are proposing to address the other end of the 

transition of care continuum. In the Stage 2 rule, we limited the action required by 

providers to sending an electronic transmission of a summary of care document. We did 

not have a related requirement for the recipient of that transmission. We did not adopt a 

certification requirement for the receiving end of a transition or referral or for the 

measure related to sending the summary, as that is a factor outside the sending provider's 

immediate control. However, in Stage 3 of meaningful use, we are proposing a measure 

for the provider as the recipient of a transition or referral requiring them to actively seek 

to incorporate an electronic summary of care document into the patient record when a 

patient is referred to them or otherwise transferred into their care. This proposal is 

designed to complete the electronic transmission loop and support providers in using 

CEHRT to support the multiple roles a provider plays in meaningful health information 

exchange. 

For the purposes of defining the cases in the denominator, we are proposing that 

what constitutes "unavailable" and therefore, may be excluded from the denominator, will 

be that a provider-- 
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 Requested an electronic summary of care record to be sent and did not receive 

an electronic summary of care document; and

 Queried at least one external source via HIE functionality and did not locate a 

summary of care for the patient, or the provider does not have access to HIE functionality 

to support such a query.

We seek comment on whether electronic alerts received by EPs from hospitals 

when a patient is admitted, seen in the emergency room or discharged from the hospital--

so called "utilization alerts"--should be included in measure two, or as a separate 

measure. Use of this form of health information exchange is increasingly rapidly, driven 

by hospital and EP efforts to improve care transitions and reduce readmissions. We also 

seek comment on which information from a utilization alert would typically be 

incorporated into a patient's record and how this is done today.

For both the first and second measures, we are proposing that a provider may use 

a wide range of health IT system for health information exchange to receive or send an 

electronic summary of care document, but must use their certified EHR technology to 

create the summary of care document sent or to incorporate the summary of care 

document received into the patient record. We are also proposing that the receipt of the 

summary of care document (CCDA) may be passive (provider is sent the CCDA and 

incorporates it) or active (provider requests a direct transfer of the CCDA or provider 

queries an HIE for the CCDA). In the Stage 2 proposed rule, we noted the benefits of 

requiring standards for the transport mechanism for health information exchange 

consistently nationwide (77 FR 13723). We requested public comment in that proposed 
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rule on the Nationwide Health Information Network specifications and a governance 

mechanism for health information exchange to be established by ONC. In the final rule, 

a governance mechanism option was included in the second measure for the Stage 2 

summary of care objective at 77 FR 54020. In this Stage 3 proposed rule, we again seek 

comment on a health information exchange governance mechanism. Specifically we seek 

comment on whether providers who create a summary of care record using CEHRT for 

purposes of Measure 1 should be permitted to send the created summary of care record 

either-- (1) through any electronic means; or (2) in a manner that is consistent with the 

governance mechanism ONC establishes for the nationwide health information 

network. We additionally seek comment on whether providers who are receiving a 

summary of care record using CEHRT for the purposes of Measure 2 should have a 

similar requirement for the transport of summary of care documents requested from a 

transitioning provider. Finally, we seek comment on how a governance mechanism 

established by ONC at a later date could be incorporated into the EHR Incentive 

Programs for purposes of encouraging interoperable exchange that benefits patients and 

providers, including how the governance mechanism should be captured in the 

numerator, denominator, and thresholds for both the first (send) and second (receive) 

measures of this Health Information exchange objective. 

For the third measure, we are proposing a measure of clinical information 

reconciliation which incorporates the Stage 2 objective for medication reconciliation and 

expands the options to allow for the reconciliation of other clinical information such as 

medication allergies, and problems which will allow providers additional flexibility in 
CMS-3310-P 129

meeting the measure in a way that is relevant to their scope of practice. In the Stage 2 

final rule, we outlined the benefits of medication reconciliation, which enables providers 

to validate that the patient's list of active medications is accurate (77 FR 54011 through 

54012). This activity improves patient safety, improves care quality, and improves the 

validity of information that the provider shares with others through health information 

exchange. We believe that reconciliation of medication allergies and problems affords 

similar benefits. 

For this proposed measure, we specify that the EP, eligible hospital, or CAH that 

receives the patient into their care should conduct the clinical information reconciliation. 

It is for the receiving provider that up-to-date information will be most crucial to make 

informed clinical judgments for patient care. We reiterate that this measure does not 

dictate what subset of information must be included in reconciliation. Information 

included in the process is determined by the provider's clinical judgment of what is most 

relevant to patient care. 

For this measure, we propose to define clinical information reconciliation as the 

process of creating the most accurate patient-specific information in one or more of the 

specified categories by using the clinical information reconciliation capability of their 

certified EHR technology which will compare the "local" information to 

external/incoming information that is being incorporated into the certified EHR 

technology from any external source. We refer providers to the standards and 

certification criteria for clinical information reconciliation proposed in ONC's 

2015 Edition proposed rule published elsewhere in this issue of the Federal Register. 
CMS-3310-P 130

As with medication reconciliation, we believe that an electronic exchange of 

information following the transition of care of a patient is the most efficient method of 

performing clinical information reconciliation. 

We recognize that workflows to reconcile clinical information vary widely across 

providers and settings of care, and we request comment on the challenges that this 

objective might present for providers, and how such challenges might be mitigated, while 

preserving the policy intent of the measure. In particular, we solicit comment on the 

following: 

 Automation and Manual Reconciliation. The Stage 2 measure does not specify 

whether reconciliation must be automated or manual. Some providers have expressed 

concern over the automatic inclusion of data in the patient record from referring 

providers, while others have indicated that requiring manual reconciliation imposes 

significant workflow burden. We also seek comment on whether the use and display of 

meta-tagged data could address concerns related to the origin of data and thereby permit 

more automated reconciliation of these data elements.

 Review of Reconciled Information. Depending on clinical setting, this measure 

could be accomplished through manual reconciliation or through automated functionality. 

In either scenario, should the reconciliation or review of automated functionality be 

performed only by the same staff allowed under the Stage 3 requirements for the 

Computerized Provider Order Entry objective? 
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 What impact would the requirement of clinical information reconciliation have 

on workflow for specialists? Are there particular specialties where this measure would 

be difficult to meet?

 What additional exclusions, if any, should be considered for this measure? 

We also encourage comment on the proposal to require reconciliation of all three 

clinical information reconciliation data sets, or if we should potentially require providers 

to choose 2 of 3 information reconciliation data sets relevant to their specialty or patient 

population. We expect that most providers would find that conducting clinical 

information reconciliation for medications, medication allergies, and problem lists is 

relevant for every patient encountered. We solicit examples describing challenges and 

burdens that providers who deliver specialist care or employ unique clinical workflow 

practices may experience in completing clinical information reconciliation for all three 

data sets and whether an exclusion should be considered for providers for whom such 

reconciliation may not be relevant to their scope of practice or patient population. 

Additionally, we solicit comments around the necessity to conduct different types of 

clinical information reconciliation of data for each individual patient. For example, it is 

possible that the data for certain patients should always be reviewed for medication 

allergy reconciliation, when it may not be as relevant to other patient populations. 

We propose that to meet this objective, a provider must attest to the numerator 

and denominator for all three measures but would only be required to successfully meet 

the threshold for two of the three proposed measures. We invite public comment on this 

proposal.
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Measure 1: To calculate the percentage of the first measure, CMS and ONC 

have worked together to define the following for this measure: 

Denominator: Number of transitions of care and referrals during the EHR 

reporting period for which the EP or eligible hospital's or CAH's inpatient or emergency 

department (POS 21 or 23) was the transferring or referring provider.

Numerator: The number of transitions of care and referrals in the denominator 

where a summary of care record was created using certified EHR technology and 

exchanged electronically.

Threshold: The percentage must be more than 50 percent in order for an EP, 

eligible hospital, or CAH to meet this measure. 

Exclusion: An EP neither transfers a patient to another setting nor refers a patient 

to another provider during the EHR reporting period.

*Any EP that conducts 50 percent or more of his or her patient encounters in a county 

that does not have 50 percent or more of its housing units with 4Mbps broadband 

availability according to the latest information available from the FCC on the first day of 

the EHR reporting period may exclude the measures. 

Any eligible hospital or CAH will be excluded from the measure if it is located in 

a county that does not have 50 percent or more of their housing units with 4Mbps 

broadband availability according to the latest information available from the FCC at the 

start of the EHR reporting period. 

Measure 2: To calculate the percentage of the second measure, CMS and ONC 

have worked together to define the following for this measure: 
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Denominator: Number of patient encounters during the EHR reporting period for 

which an EP, eligible hospital, or CAH was the receiving party of a transition or referral 

or has never before encountered the patient and for which an electronic summary of care 

record is available. 

Numerator: Number of patient encounters in the denominator where an electronic 

summary of care record received is incorporated by the provider into the certified EHR 

technology.

Threshold: The percentage must be more than 40 percent in order for an EP, 

eligible hospital, or CAH to meet this measure. 

Exclusion: Any EP, eligible hospital or CAH for whom the total of transitions or 

referrals received and patient encounters in which the provider has never before 

encountered the patient, is fewer than 100 during the EHR reporting period is excluded 

from this measure. 

Any EP that conducts 50 percent or more of his or her patient encounters in a 

county that does not have 50 percent or more of its housing units with 4Mbps broadband 

availability according to the latest information available from the FCC on the first day of 

the EHR reporting period may exclude the measures.

Any eligible hospital or CAH will be excluded from the measure if it is located in 

a county that does not have 50 percent or more of their housing units with 4Mbps 

broadband availability according to the latest information available from the FCC at the 

start of the EHR reporting period.
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Measure 3: To calculate the percentage, CMS and ONC have worked together to 

define the following for this measure: 

Denominator: Number of transitions of care or referrals during the EHR reporting 

period for which the EP or eligible hospital's or CAH's inpatient or emergency 

department (POS 21 or 23) was the recipient of the transition or referral or has never 

before encountered the patient. 

Numerator: The number of transitions of care or referrals in the denominator 

where the following three clinical information reconciliations were performed: 

medication list, medication allergy list, and current problem list. 

Threshold: The resulting percentage must be more than 80 percent in order for an 

EP, eligible hospital, or CAH to meet this measure. 

Exclusion: Any EP, eligible hospital or CAH for whom the total of transitions or 

referrals received and patient encounters in which the provider has never before 

encountered the patient, is fewer than 100 during the EHR reporting period is excluded 

from this measure. 

Any EP that conducts 50 percent or more of his or her patient encounters in a 

county that does not have 50 percent or more of its housing units with 4Mbps broadband 

availability according to the latest information available from the FCC on the first day of 

the EHR reporting period may exclude the measure.

Any eligible hospital or CAH will be excluded from the measure if it is located in 

a county that does not have 50 percent or more of their housing units with 4Mbps 
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broadband availability according to the latest information available from the FCC at the 

start of the EHR reporting period.

We welcome comment on these proposals. 

Objective 8: Public Health and Clinical Data Registry Reporting

This objective builds on the requirements set forth in the Stage 2 final rule 

(77 FR 54021 through 54026). In addition, this objective includes improvements to the 

Stage 2 measures, supports innovation that has occurred since the Stage 2 rule was 

released, and adds flexibility in the options that an eligible provider has to successfully 

report. 

Further, this objective places increased focus on the importance of the ongoing 

lines of communication that should exist between providers and public health agencies 

(PHAs) or as further discussed later in this section, between providers and clinical data 

registries (CDRs). Providers' use of certified EHR technology can increase the flow of 

secure health information and reduce the burden that otherwise could attach to these 

important communications. The purpose of this Stage 3 objective is to further advance 

communication between providers and PHAs or CDRs, as well as strengthen the capture 

and transmission of such health information within the care continuum. 

In this Stage 3 proposed rule, we are proposing changes to the Stage 1 and Stage 2 

public health and specialty registry objectives to consolidate the prior objectives and 

measures into a single objective in alignment with efforts to streamline the program and 

support flexibility for providers. We propose to include a new measure for case reporting 

to reflect the diverse ways that providers can electronically exchange data with PHAs and 
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CDRs. In addition, we are using new terms such as public health registries and clinical 

data registries to incorporate the Stage 2 designations for cancer registries and specialized 

registries under these categories which are used in the health care industry to designate a 

broader range of registry types. We further explain the use of these terms within the 

specifications outlined for each applicable measure. 

Proposed Objective: The EP, eligible hospital, or CAH is in active engagement with a 

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

EHR technology, except where prohibited, and in accordance with applicable law and 

practice. 

For Stage 3, we are proposing to remove the prior "ongoing submission"

requirement and replace it with an "active engagement" requirement. Depending on the 

measure, the ongoing submission requirement from the Stage 1 and Stage 2 final rules 

required the successful ongoing submission of applicable data from certified EHR 

technology to a PHA or CDR for the entire EHR reporting period. As part of the Stage 2 

final rule, we provided examples demonstrating how ongoing submission could satisfy 

the measure (77 FR 54021). However, stakeholders noted that the ongoing submission 

requirement does not accurately capture the nature of communication between providers 

and a PHA or CDR, and does not consider the many steps necessary to arrange for 

registry submission to a PHA or CDR. Given this feedback, we believe that "active 

engagement" as defined later in this section is more aligned with the process providers 

undertake to report to a CDR or to a PHA. 
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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 
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30 days; failure to respond twice within an EHR reporting period would result in that 

provider not meeting the measure. 

Active Engagement Option 3 – Production: The EP, eligible hospital, or CAH has 

completed testing and validation of the electronic submission and is electronically 

submitting production data to the PHA or CDR.

We also propose to provide support to providers seeking to meet the requirements 

of this objective by creating a centralized repository of national, state, and local PHA and 

CDR readiness. In the Stage 2 final rule (77 FR 54021), we noted the benefits of 

developing a centralized repository where a PHA could post readiness updates regarding 

their ability to accept electronic data using specifications prescribed by ONC for the 

public health objectives. We also published, pursuant to the Paperwork Reduction Act of 

1995, a notice in the Federal Register on February 7, 2014 soliciting public comment on 

the proposed information collection required to develop the centralized repository on 

public health readiness (79 FR 7461). We considered the comments and we now propose 

moving forward with the development of the centralized repository. The centralized 

repository is integral to meaningful use and is expected to be available by the start of 

CY 2017. We expect that the centralized repository will include readiness updates for 

PHAs and CDRs at the state, local, and national level. We welcome your comments on 

the use and structure of the centralized repository.

Proposed Measures: We are proposing a total of six possible measures for this 

objective. EPs would be required to choose from measures 1 through 5, and would be 

required to successfully attest to any combination of three measures. Eligible hospitals 
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and CAHs would be required to choose from measures one through six, and would be 

required to successfully attest to any combination of four measures. The measures are as 

shown in Table 5. As noted, measures four and five for Public Health Registry Reporting 

and Clinical Data Registry Reporting may be counted more than once if more than one 

Public Health Registry or Clinical Data Registry is available.

TABLE 5: MEASURES FOR OBJECTIVE 8: PUBLIC HEALTH AND 

CLINICAL DATA REGISTRY REPORTING OBJECTIVE

Measure Maximum times measure can 

count towards objective for EP

Maximum times measure can 

count towards objective for 

eligible hospital or CAH

Measure 1 – Immunization 

Registry Reporting

1 1

Measure 2 – Syndromic 

Surveillance Reporting

1 1

Measure 3 – Case Reporting 1 1

Measure 4 - Public Health 

Registry Reporting*

3 4

Measure 5 - Clinical Data 

Registry Reporting**

3 4

Measure 6 - Electronic 

Reportable Laboratory Results

N/A 1

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

number of measures required to meet the objective.

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

number of measures required to meet the objective.

For EPs, we propose that an exclusion for a measure does not count toward the 

total of three measures. Instead, in order to meet this objective, an EP would need to 

meet three of the total number of measures available to them. If the EP qualifies for 

multiple exclusions and the remaining number of measures available to the EP is less 

than three, the EP can meet the objective by meeting all of the remaining measures 

available to them and claiming the applicable exclusions. Available measures include 

ones for which the EP does not qualify for an exclusion. 
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For eligible hospitals and CAHs, we propose that an exclusion for a measure does 

not count toward the total of four measures. Instead, in order to meet this objective an 

eligible hospital or CAH would need to meet four of the total number of measures 

available to them. If the eligible hospital or CAH qualifies for multiple exclusions and 

the total number of remaining measures available to the eligible hospital or CAH is less 

than four, the eligible hospital or CAH can meet the objective by meeting all of the 

remaining measures available to them and claiming the applicable exclusions. Available 

measures include ones for which the eligible hospital or CAH does not qualify for an 

exclusion. 

We note that we are proposing to allow EPs, eligible hospitals, and CAHs to 

choose to report to more than one public health registry to meet the number of measures 

required to meet the objective. We are also proposing to allow EPs, eligible hospitals, 

and CAHs to choose to report to more than one clinical data registry to meet the number 

of measures required to meet the objective. We believe that this flexibility allows for 

EPs, eligible hospitals, and CAHs to choose reporting options that align with their 

practice and that will aid the provider's ability to care for their patients.

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

CAH is in active engagement with a public health agency to submit immunization data 

and receive immunization forecasts and histories from the public health immunization 

registry/immunization information system (IIS). 

We believe the immunization registry reporting measure remains a priority for 

Stage 3 because the exchange of information between certified EHR technology and 
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immunization registries allows a provider to use the most complete immunization history 

available to inform decisions about the vaccines a patient may need. Public health 

agencies and providers also use immunization information for emergency preparedness 

and to estimate population immunization coverage levels of certain vaccines.

We propose that to successfully meet the requirements of this measure, 

bidirectional data exchange between the provider's certified EHR technology and the 

immunization registry/IIS is required. We understand that many states and local public 

health jurisdictions are exchanging immunization data bidirectionally with providers, and 

that the number of states and localities able to support bidirectional exchange continues 

to increase. In the 2015 Edition proposed rule published by ONC elsewhere in this issue

of the Federal Register, the ONC is proposing to adopt a bidirectional exchange 

standard for reporting to immunization registries/IIS. We believe this functionality is

important for patient safety and improved care because it allows the provider to use the 

most complete immunization record possible to make decisions on whether a patient 

needs a vaccine. Immunization registries and health IT systems also are able to provide 

immunization forecasting functions which can inform discussions between providers and 

patients on what vaccines they may need in the future and the timeline for the receipt of 

such immunizations. Therefore, we believe that patients, providers, and the public health 

community would benefit from technology that can accommodate bidirectional 

immunization data exchange. We welcome comment on this proposal.

Exclusion for Measure 1: Any EP, eligible hospital, or CAH meeting one or more 

of the following criteria may be excluded from the immunization registry reporting 
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measure if the EP, eligible hospital, or CAH: (1) does not administer any immunizations 

to any of the populations for which data is collected by their jurisdiction's immunization 

registry or immunization information system during the EHR reporting period; (2) 

operates in a jurisdiction for which no immunization registry or immunization 

information system is capable of accepting the specific standards required to meet the 

CEHRT definition at the start of the EHR reporting period; or (3) operates in a 

jurisdiction where no immunization registry or immunization information system has 

declared readiness to receive immunization data at the start of the EHR reporting period. 

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

CAH is in active engagement with a public health agency to submit syndromic 

surveillance data from a non-urgent care ambulatory setting for EPs, or an emergency or 

urgent care department for eligible hospitals and CAHs (POS 23). This measure remains 

a policy priority for Stage 3 because electronic syndromic surveillance is valuable for 

early detection of outbreaks, as well as monitoring disease and condition trends. We are 

distinguishing between EPs and eligible hospital or CAHs reporting locations because, as 

discussed in the Stage 2 final rule, few PHAs appeared to have the ability to accept 

non-emergency or non-urgent care ambulatory syndromic surveillance data electronically 

(77 FR 53979). We continue to observe differences in the infrastructure and current 

environments for supporting electronic syndromic surveillance data submission to PHAs 

between eligible hospitals or CAHs and EPs. Because eligible hospitals and CAHs send 

syndromic surveillance data using different methods as compared to EPs, we are defining 

slightly different exclusions for each setting as described later in this section. 
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Exclusion for EPs for Measure 2: Any EP meeting one or more of the following 

criteria may be excluded from the syndromic surveillance reporting measure if the EP: 

(1) does not treat or diagnose or directly treat any disease or condition associated with a 

syndromic surveillance system in their jurisdiction; (2) operates in a jurisdiction for 

which no public health agency is capable of receiving electronic syndromic surveillance 

data from EPs in the specific standards required to meet the CEHRT definition at the start 

of the EHR reporting period; or (3) operates in a jurisdiction where no public health 

agency has declared readiness to receive syndromic surveillance data from EPs at the 

start of the EHR reporting period.

Exclusion for eligible hospitals/CAHs for Measure 2: Any eligible hospital or 

CAH meeting one or more of the following criteria may be excluded from the syndromic 

surveillance reporting measure if the eligible hospital or CAH: (1) does not have an 

emergency or urgent care department; (2) operates in a jurisdiction for which no public 

health agency is capable of receiving electronic syndromic surveillance data from eligible 

hospitals or CAHs in the specific standards required to meet the CEHRT definition at the 

start of the EHR reporting period; or (3) operates in a jurisdiction where no public health 

agency has declared readiness to receive syndromic surveillance data from eligible 

hospitals or CAHs at the start of the EHR reporting period.

Measure 3 - Case Reporting: The EP, eligible hospital, or CAH is in active 

engagement with a public health agency to submit case reporting of reportable 

conditions. 
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This is a new reporting option that was not part of Stage 2. The collection of 

electronic case reporting data greatly improves reporting efficiencies between providers 

and the PHA. Public health agencies collect "reportable conditions", as defined by the 

state, territorial, and local PHAs to monitor disease trends and support the management 

of outbreaks. In many circumstances, there has been low reporting compliance because 

providers do not know when, where, or how to report. In some cases, the time burden to 

report can also contribute to low reporting compliance. However, electronic case 

reporting presents a core benefit to public health improvement and a variety of 

stakeholders have identified electronic case reporting as a high value element of patient 

and continuity of care. Further, we believe that electronic case reporting reduces 

burdensome paper-based and labor-intensive case reporting. Electronic reporting will 

support more rapid exchange of case reporting information between PHAs and providers

and can include structured questions or data fields to prompt the provider to supply 

additional required or care-relevant information. 

To support case reporting, the ONC has proposed a certification criterion that 

includes capabilities to enable certified EHR systems to send initial case reporting data 

and receive a request from the public health agency for supplemental or ad hoc structured 

data in the 2015 Edition proposed rule, published elsewhere in this issue of the Federal 

Register.

Exclusion for Measure 3: Any EP, eligible hospital, or CAH meeting one or more 

of the following criteria may be excluded from the case reporting measure if the EP, 

eligible hospital, or CAH: (1) does not treat or diagnose any reportable diseases for 
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which data is collected by their jurisdiction's reportable disease system during the EHR 

reporting period; (2) operates in a jurisdiction for which no public health agency is 

capable of receiving electronic case reporting data in the specific standards required to 

meet the CEHRT definition at the start of the EHR reporting period; or (3) operates in a 

jurisdiction where no public health agency has declared readiness to receive electronic 

case reporting data at the start of the EHR reporting period. 

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

CAH is in active engagement with a public health agency to submit data to public health 

registries. 

In the Stage 2 final rule, we were purposefully general in our use of the term 

"specialized registry" (other than a cancer registry) to encompass both registry reporting 

to public health agencies and clinical data registries in order to prevent inadvertent 

exclusion of certain registries through an attempt to be more specific (77 FR 54030). In 

response to insight gained from the industry through listening sessions, public forums, 

and reponses to the February 2014 Public Health Reporting RFI; we propose to carry 

forward the concept behind this broad category from Stage 2, but also propose to split 

public health registry reporting from clinical data registry reporting into two separate 

measures which better define the potential types of registries available for reporting. We 

propose to define a "public health registry" as a registry that is administered by, or on 

behalf of, a local, state, territorial, or national PHA and which collects data for public 

health purposes. While immunization registries are a type of public health registry, we 

propose to keep immunization registry reporting separate from the public health registry 
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reporting measure to retain continuity from Stage 1 and 2 policy in which immunization 

registry reporting was a distinct and separate objective (77 FR 54023). We believe it is 

important to retain the public health registry reporting option for Stage 3 because these 

registries allow the public health community to monitor health and disease trends, and 

inform the development of programs and policy for population and community health 

improvement.

We reiterate that any EP, eligible hospital, or CAH may report to more than one 

public health registry to meet the total number of required measures for the objective. 

For example, if a provider meets this measure through reporting to both the National 

Hospital Care Survey and the National Healthcare Safety Network registry, the provider 

could get credit for meeting two measures. ONC will consider the adoption of standards 

and implementation guides in future rulemaking. Should these subsequently be finalized, 

they may then be adopted as part of the certified EHR technology definition as it relates 

to meeting the public health registry reporting measure through future rulemaking for the 

EHR Incentive Programs. 

We further note that ONC adopted standards for ambulatory cancer case reporting 

in its final rule "2014 Edition, Release 2 EHR Certification Criteria and the ONC HIT 

Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health 

Information Exchange" (79 FR 54468) and we provided EPs the option to select the 

cancer case reporting menu objective in the Stage 2 final rule (77 FR 54029 through 

54030). We included cancer registry reporting as a separate objective from specialized 

registry reporting because it was more mature in its development than other registry 
CMS-3310-P 147

types, not because other reporting was intended to be excluded from meaningful use. For 

the Stage 3 public health registry reporting measure, given the desire to provide more 

flexible options for providers to report to the registries most applicable for their scope of 

practice, we propose that EPs would have the option of counting cancer case reporting 

under the public health registry reporting measure. We note that cancer case reporting is 

not an option for eligible hospitals and CAHs under this measure because hospitals have 

traditionally diagnosed or treated cancers and have the infrastructure needed to report 

cancer cases.

Exclusions for Measure 4: Any EP, eligible hospital, or CAH meeting at least one 

of the following criteria may be excluded from the public health registry reporting 

measure if the EP, eligible hospital, or CAH: (1) does not diagnose or directly treat any 

disease or condition associated with a public health registry in their jurisdiction during 

the EHR reporting period; (2) operates in a jurisdiction for which no public health agency 

is capable of accepting electronic registry transactions in the specific standards required 

to meet the CEHRT definition at the start of the EHR reporting period; or (3) operates in 

a jurisdiction where no public health registry for which the EP, eligible hospital, or CAH 

is eligible has declared readiness to receive electronic registry transactions at the 

beginning of the EHR reporting period.

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

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

As discussed in the Public Health Registry Reporting measure, we propose to 

split specialized registry reporting into two separate, clearly defined measures: public 
CMS-3310-P 148

health registry reporting and clinical data registry reporting. In Stage 2 for EPs, reporting 

to specialized registries is a menu objective and this menu objective includes reporting to 

clinical data registries. For Stage 3, we propose to include clinical data registry reporting 

as an independent measure. The National Quality Registry Network defines clinical data 

registries as those that record information about the health status of patients and the 

health care they receive over varying periods of time.12 We propose to further 

differentiate between clinical data registries and public health registries as follows: for 

the purposes of meaningful use, "public health registries" are those administered by, or 

on behalf of, a local, state, territorial, or national public health agencies; and "clinical 

data registries" are administered by, or on behalf of, other non-public health agency 

entities. We believe that clinical data registries are important for providing information 

that can inform patients and their providers on the best course of treatment and for care 

improvements, and can support specialty reporting by developing reporting for areas not 

usually covered by PHAs but that are important to a specialist's provision of care. 

Clinical data registries can also be used to monitor health care quality and resource use.

As noted previously, we reiterate that any EP, eligible hospital, or CAH may 

report to more than one clinical data registry to meet the total number of required 

measures for this objective. ONC will consider the adoption of standards and 

implementation guides in future rulemaking. Should these subsequently be finalized, 

they may then be adopted as part of the certified EHR technology definition as it relates 

to meeting the clinical data registry reporting measure through future rulemaking for the 

EHR Incentive Programs.

 

12 https://download.ama-assn.org/resources/doc/cqi/x-pub/nqrn-what-is-clinical-data-registry.pdf.
CMS-3310-P 149

Exclusions for Measure 5: Any EP, eligible hospital, or CAH meeting at least one 

of the following criteria may be excluded from the clinical data registry reporting 

measure if the EP, eligible hospital, or CAH: (1) does not diagnose or directly treat any 

disease or condition associated with a clinical data registry in their jurisdiction during the 

EHR reporting period; (2) operates in a jurisdiction for which no clinical data registry is 

capable of accepting electronic registry transactions in the specific standards required to 

meet the CEHRT definition at the start of the EHR reporting period; or (3) operates in a 

jurisdiction where no clinical data registry for which the EP, eligible hospital, or CAH is 

eligible has declared readiness to receive electronic registry transactions at the beginning 

of the EHR reporting period.

Measure 6 – Electronic Reportable Laboratory Result Reporting: The 

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

electronic reportable laboratory results. This measure is available to eligible hospitals 

and CAHs only. Electronic reportable laboratory result reporting to PHAs is required for 

eligible hospitals and CAHs in Stage 2 (77 FR 54021). We propose to retain this 

measure for Stage 3 to promote the exchange of laboratory results between eligible 

hospitals/CAHs and PHAs for improved timeliness, reduction of manual data entry 

errors, and more complete information.

Exclusion for Measure 6: Any eligible hospital or CAH meeting one or more of 

the following criteria may be excluded from the electronic reportable laboratory result 

reporting measure if the eligible hospital or CAH: (1) does not perform or order 

laboratory tests that are reportable in their jurisdiction during the EHR reporting period; 
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(2) operates in a jurisdiction for which no public health agency is capable of accepting 

the specific ELR standards required to meet the CEHRT definition at the start of the EHR 

reporting period; or (3) operates in a jurisdiction where no public health agency has 

declared readiness to receive electronic reportable laboratory results from an eligible 

hospital or CAH at the start of the EHR reporting period.

The use of CEHRT for the Public Health and Clinical Data Registry Reporting 

Objective

As proposed previously, the Public Health and Clinical Data Registry Reporting 

objective requires active engagement with a public health agency to submit electronic 

public health data from certified EHR technology. ONC defined the standards and 

certification criteria to meet the definition of CEHRT in its 2011, 2014, and 2014 

Release 2 Edition EHR certification criteria rules (see section II.B. of the "2014 Edition, 

Release 2 EHR Certification Criteria and the ONC HIT Certification Program; 

Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange" for 

a full description of ONC's regulatory history; (79 FR 54434)). For example, ONC 

adopted standards for immunization reporting (see § 170.314(f)(1) and (f)(2)), inpatient 

syndromic surveillance (see § 170.314(f)(3) and (f)(7)), ELR (see § 170.314(f)(4)), and 

cancer case reporting (see § 170.314(f)(5) and (f)(6)) in its 2014 Edition final rule. 

We support ONC's intent to promote standardized and interoperable exchange of 

public health data across the country. Therefore, to meet all of the measures within this 

public health objective EPs, eligible hospitals, and CAHs must use CEHRT as we 

propose to define it under § 495.4 in this proposed rule and use the standards included in 
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the 2015 Edition proposed rule published elsewhere in this edition of the Federal 

Register. We anticipate that as new public health registries and clinical data registries 

are created, ONC and CMS will work with the public health community and clinical 

specialty societies to develop ONC-certified electronic reporting standards for those 

registries so that providers have the option to count participation in those registries under 

the measures of this objective. ONC will look to adopt such standards, as appropriate, in 

future rules published by ONC. 

We welcome public comment on these proposals.
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II. Provisions of the Proposed Regulations

A. Meaningful Use Requirements, Objectives and Measures

2. Certified EHR Technology (CEHRT) Requirements

Certified EHR technology is defined for the Medicare and Medicaid EHR 

Incentive Programs at 42 CFR 495.4, which references ONC's definition of CEHRT 

under 45 CFR 170.102. The definition establishes the requirements for EHR technology 

that must be used by providers to meet the meaningful use objectives and measures. The 

Stage 2 final rule requires that CEHRT must be used by EPs, eligible hospitals, and 

CAHs to satisfy their CQM reporting requirements under the Medicare and Medicaid 

EHR Incentive Programs. In addition, the CQM data reported to CMS must originate 

from EHR technology that is certified to "capture and export" in accordance with 

45 CFR 170.314(c)(1) and "electronic submission" in accordance with 

45 CFR 170.314(c)(3) (77 FR 54053). 

On September 4, 2014, CMS and ONC published a final rule in the Federal 

Register (79 FR 52910 through 52933) that, among other things, modified the 

meaningful use requirements for 2014 and the CEHRT definition. 

First, we granted flexibility to providers who experienced product availability 

issues that affected their ability to fully implement EHR technology certified to the 2014 

Edition of certification criteria (79 FR 52913 through 52926). We allowed those EPs, 

eligible hospitals, and CAHs to continue using either EHR technology certified to the 

2011 Edition, or a combination of EHR technology certified to the 2011 Edition and 2014 

Edition, for the EHR reporting periods in CY 2014 and FY 2014. EPs, eligible hospitals, 
CMS-3310-P 153

and CAHs could take one of these approaches if they were unable to fully implement 

EHR technology certified to the 2014 Edition for an EHR reporting period in 2014 due to 

delays in the availability of EHR technology certified to the 2014 Edition. 

Second, we established that in order to receive an incentive payment for 2014 

under Medicaid for adopting, implementing, or upgrading CEHRT, a provider must 

adopt, implement, or upgrade to EHR technology certified to the 2014 Edition and meet 

the CEHRT definition (79 FR 52925 through 52926). 

Finally, ONC revised the CEHRT definition under 45 CFR 170.102 to align with 

our policy allowing for the use of EHR technology certified to the 2011 Edition, or a 

combination of EHR technology certified to the 2011 Edition and 2014 Edition, in 2014

(79 FR 52930).

For further detail on the changes to the requirements for 2014 and CEHRT 

definition, we refer readers to the 2014 CEHRT Flexibility final rule (79 FR 52910 

through 52933). 

a. CEHRT Definition for the EHR Incentive Programs

As we have stated previously in rulemaking, the statute and regulations require 

EPs, eligible hospitals, and CAHs to use "Certified EHR Technology" if they are to be 

considered meaningful EHR users and eligible for incentive payments under Medicare or 

Medicaid, and to avoid payment adjustments under Medicare (for example, see section 

1848(o)(2)(A)(i) of the Act, and 42 CFR 495.4). However, in contrast to prior 

rulemaking cycles where ONC has established a meaningful-use-specific CEHRT 

definition for the EHR Incentive Programs that CMS has adopted by cross-reference 
CMS-3310-P 154

under 42 CFR 495.4, we propose to take a different approach under which we would 

define the term "Certified EHR Technology," and that definition would be specific to the 

EHR Incentive Programs. 

This proposed change is designed to simplify the overall regulatory relationship 

between ONC and CMS rules for stakeholders and to ensure that relevant CMS policy for 

the EHR Incentive Programs is clearly referenced in CMS regulations. For example, 

ONC's definition of CEHRT under 45 CFR 170.102 includes the compliance dates for 

EPs, eligible hospitals, and CAHs to use EHR technology certified to a particular edition 

of certification criteria to meet the CEHRT definition and for purposes of the EHR 

Incentive Programs, such as the requirement to use EHR technology certified to the 2014 

Edition beginning in 2015. Under the proposed new approach, we would establish 

through rulemaking for the EHR Incentive Programs (either with stand-alone rulemaking 

or through other vehicles such as the annual Medicare payment rules) the compliance 

dates by which providers must use EHR technology certified to a particular edition of 

certification criteria to meet the CEHRT definition, which would be reflected in our

regulations under 42 CFR part 495 rather than ONC's regulations under 45 CFR Part 170. 

b. Defining CEHRT for 2015 through 2017 and for 2018 and Subsequent Years

In adopting a CEHRT definition specific for the EHR Incentive Programs, we 

propose to include, as currently for the ONC CEHRT definition under 45 CFR 170.102, 

the relevant Base EHR definitions adopted by ONC in 45 CFR 170.102 and other ONC 

certification criteria relevant to the EHR Incentive Programs. We refer readers to ONC's 

2015 Edition proposed rule published elsewhere in this issue of the Federal Register for 
CMS-3310-P 155

the proposed 2015 Edition Base EHR definition and discussion of the 2014 Edition Base 

EHR definition. We are including the Base EHR definition(s) because as ONC explained 

in the 2014 Edition final rule "2014 Edition, Release 2 EHR Certification Criteria and the 

ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced 

Health Information Exchange" (77 FR 54443 through 54444) the "Base EHR" essentially

serves as a substitute for the term "Qualified EHR" in the definition of CEHRT. The 

term "Qualified EHR" is defined in section 3000(13) of the PHSA, to include certain 

capabilities listed in that section, and is included in the statutory definition of "certified 

EHR technology" for the EHR Incentive Programs (for example, see section 1848(o)(4) 

of the Act). The Base EHR definition(s) also include additional capabilities as proposed 

by ONC that we agree all providers should have that are participating in the EHR 

Incentive Programs to support their attempts to meet meaningful use objectives and 

measures as well as interoperable health information exchange.

We propose to define the editions of certification criteria that may be used for 

years 2015 through 2017 to meet the CEHRT definition. At a minimum, EPs, eligible 

hospitals, and CAHs would be required to use EHR technology certified to the 2014 

Edition certification criteria for their respective EHR reporting periods in 2015 through 

2017. A provider may also upgrade to the 2015 Edition prior to 2018 to meet the 

required certified EHR technology definition for the EHR reporting periods in 2015, 

2016, or 2017, or they may use a combination of 2014 and 2015 Editions prior to 2018 if 

they have modules from both Editions which meet the requirements for the objectives 

and measures or if they fully upgrade during an EHR reporting period. 
CMS-3310-P 156

Based on experience with delays in the availability of EHR technology certified to 

the 2014 Edition for providers to implement and use to meet meaningful use for an EHR 

reporting period in 2014, we propose to include as part of the CEHRT definition a longer 

period of time for providers to use technology certified to the 2014 Edition in an effort to 

give providers more time in updating their technology to the 2015 Edition before the 

EHR reporting period in 2018. We also propose to make the use of a combination of 

technology certified to the 2014 Edition and 2015 Edition to meet the CEHRT definition 

more flexible in 2015 through 2017 by taking into account ONC's proposed new privacy 

and security certification approach for health IT (see ONC's 2015 Edition proposed rule 

published elsewhere in this issue of the Federal Register). Specifically, as a provider 

updates to technology certified to the 2015 Edition, the provider would not necessarily 

need to continue to meet the privacy and security capability requirements of the 2014 

Edition Base EHR definition because the technology they adopt certified to the 

2015 Edition would include necessary privacy and security capabilities. Additionally, 

because ONC is proposing, for the 2015 Edition, to no longer require certification of 

Health IT Modules to capabilities that support meaningful use objectives with 

percentage-based measures, we propose to include these capabilities 

(45 CFR 170.314(g)(1) or (2) or 45 CFR 170.315(g)(1) or (2)), as applicable, in the 

CEHRT definition for 2015 through 2017 so that providers have technology that can 

appropriately record and calculate meaningful use measures. We note that there are many 

combinations of 2014 and 2015 Edition certified technologies that could be used to 

successfully meet the transitions of care requirements included in the 2014 and 
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2015 Edition Base EHR definitions for the purposes of meeting meaningful use 

objectives and measures. We believe we have identified all combinations in the proposed 

regulation text under § 495.4 that could be used to meet the CEHRT definition through 

2017 and be used for the purposes of meeting meaningful use objectives and measures. 

We welcome comments on the accuracy of the identified available options. 

We propose that starting with 2018, all EPs, eligible hospitals, and CAHs would 

be required to use technology certified to the 2015 Edition to meet the CEHRT definition 

and demonstrate meaningful use for an EHR reporting period in 2018 and subsequent 

years. The CEHRT definition would include, for the reasons discussed previously, 

meeting the 2015 Edition Base EHR definition and having other important capabilities, 

that include the capabilities to--

 Record or create and incorporate family health history; 

 Capture patient health information such as advance directives; 

 Record numerators and denominators for meaningful use objectives with 

percentage-based measures and calculate the percentages; 

 Calculate and report clinical quality measures; and 

 Any other capabilities needed to be a Meaningful EHR User. 

For information on 2015 Edition certification criteria that include these capabilities and 

are associated with proposed Meaningful Use objectives for Stage 3, please see the 

2015 Edition proposed rule published elsewhere in this issue of the Federal Register. 

We expect that the certification criteria with capabilities that support CQM calculation 
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and reporting would be jointly proposed with CQM reporting requirements in a separate 

rulemaking. 

c. Proposed Definition for CEHRT

For the reasons stated previously, we propose to adopt a definition of Certified 

EHR Technology under 42 CFR 495.4 for the Medicare and Medicaid EHR Incentive 

Programs that would apply for the EHR reporting periods in 2015 up to and including 

2017 and for the EHR reporting periods in 2018 and subsequent years. We refer readers 

to ONC's 2015 Edition proposed rule published elsewhere in this issue of the Federal 

Register for further explanation of the concepts and terms used in our proposed 

definition of Certified EHR Technology, including the 2014 Edition Base EHR 

definition, 2015 Edition Base EHR definition, certification criteria, and the regulation 

text under 45 CFR Part 170.
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B. Reporting on Clinical Quality Measures Using Certified EHR Technology by EPs, 

Eligible Hospitals, and Critical Access Hospitals

1. Clinical Quality Measure (CQM) Requirements for Meaningful Use in 2017 and 

Subsequent Years

Under sections 1848(o)(2)(A),1886(n)(3)(A), and 1814(l)(3)(A) of the Act and 

42 CFR 495.4, EPs, eligible hospitals, and CAHs must report on CQMs selected by CMS 

using certified EHR technology, as part of being a meaningful EHR user under the 

Medicare and Medicaid EHR Incentive Programs.

In regard to the selection of CQMs, we expect to continue to include CQMs that 

align with the National Quality Strategy; as well as, the our Quality Strategy. We also 

expect to consider programmatic goals and outcome measures that would advance patient 

and population health. 

a. Clinical Quality Measure Reporting Requirements for EPs

Section 1848(o)(2)(B)(iii) of the Act requires that in selecting measures for EPs

for the Medicare EHR Incentive Program, and in establishing the form and manner of 

reporting, the Secretary shall seek to avoid redundant or duplicative reporting, including 

reporting under subsection (k)(2)(C) for the Physician Quality Reporting System (PQRS). 

Consistent with that requirement, in the Stage 2 final rule, we finalized a policy to align 

certain aspects of reporting CQMs for the Medicare EHR Incentive Program for EPs with 

reporting under the PQRS. Specifically, we stated that Medicare EPs who participate in 

both the PQRS and the Medicare EHR Incentive Program will satisfy the CQM reporting 

component of meaningful use if they submit and satisfactorily report PQRS CQMs under 
CMS-3310-P 160

the PQRS's EHR reporting option using CEHRT (77 FR 54058). 

Section 1848(m)(7) of the Act requires the Secretary to develop a plan to integrate 

reporting on quality measures under the PQRS with reporting requirements under the 

Medicare EHR Incentive Program relating to the meaningful use of electronic health 

records. Therefore, it is our goal to align the reporting requirements for the CQM 

component of meaningful use under the Medicare EHR Incentive Program and for PQRS 

wherever possible. Historically, most requirements for the Medicare and Medicaid EHR 

Incentive Programs have been established through stand-alone rulemaking, such as the 

rules for Stage 1 (75 FR 44314 through 44588) and Stage 2 (77 FR 53968 through 

54162), which span multiple program years. This limited our ability to align the EHR 

Incentive Program with the requirements established in the annual Medicare payment 

rules for other CMS quality programs affecting physicians and other EPs. 

To further our goals of alignment and avoiding redundant or duplicative reporting 

across the various CMS quality reporting programs, we intend to address CQM reporting 

requirements for the Medicare and Medicaid EHR Incentive Program for EPs for 2017 

and subsequent years in the Medicare Physician Fee Schedule (PFS) rulemaking, which 

also establishes the requirements for PQRS and other quality programs affecting EPs. 

We note that the form and manner of reporting of CQMs for Medicare EPs would also be 

included in the PFS, while for Medicaid we would continue to allow the states to 

determine form and method requirements subject to CMS approval. We propose to 

continue the policy of establishing certain CQM requirements that apply for both the 

Medicare and Medicaid EHR Incentive Programs including a common set of CQMs and 
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the reporting periods for CQMs in the EHR Incentive Programs. However, we believe 

that receiving and reviewing public comments for various CMS quality programs at one 

time (for example, EHR Incentive Program, PQRS, Physician Compare); and finalizing 

the requirements for these programs simultaneously, would allow us to better align these 

programs for EPs to support streamlined reporting and program efficacy. We propose to 

continue to support active communication with providers to facilitate the sharing of 

information related to CQM selection and reporting, the announcement of opportunities 

for public comment on CQM selection and reporting, and upcoming or relevant CQM 

program milestones in partnership with state Medicaid programs and the Medicare 

quality reporting programs. We propose to continue to post the defined CQM sets and 

the published electronic specifications for CQM that are in use for all aligned programs 

on the CMS website as currently posted on the eCQM Library page: 

http://www.cms.gov/Regulations-andGuidance/Legislation/EHRIncentivePrograms/eCQM_Library.html. 

b. CQM Reporting Requirements for Eligible Hospitals and Critical Access Hospitals

Section 1886(n)(3)(B)(iii) of the Act requires that, in selecting measures for 

eligible hospitals for the Medicare EHR Incentive Program, and establishing the form and 

manner for reporting measures, the Secretary shall seek to avoid redundant or duplicative 

reporting with reporting otherwise required, including reporting under 

section 1886(b)(3)(B)(viii) of the Act, the Hospital IQR Program. 

Similar to our intentions for EPs discussed previously, and to further our 

alignment goal among CMS quality reporting programs for eligible hospitals and CAHs, 
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and avoid redundant or duplicative reporting among hospital programs, we intend to 

address CQM reporting requirements for the Medicare and Medicaid EHR Incentive 

Program for eligible hospitals and CAHs for 2016, 2017, and future years, in the 

Inpatient Prospective Payment System (IPPS) rulemaking. IPPS rulemaking also 

establishes the requirements for the Hospital IQR Program and other quality programs 

affecting hospitals. We intend to include all Medicare EHR Incentive Program 

requirements related to CQM reporting in the IPPS rulemaking including, but not limited 

to, new program requirements, reporting requirements, reporting and submission periods, 

reporting methods, and information regarding the CQMs. As with EPs, for the Medicaid 

EHR Incentive Program we would continue to allow the states to determine form and 

method requirements subject to CMS approval. However, as previously noted, this 

proposal would continue the policy of establishing certain CQM requirements that apply 

for both the Medicare and Medicaid EHR Incentive Programs including a common set of 

CQMs and the reporting periods for CQMs in the EHR Incentive Programs. We believe 

that receiving and reviewing public comments for various CMS quality programs at one 

time and finalizing the requirements for these programs simultaneously would allow us to 

better align these programs for eligible hospitals and CAHs, allow more flexibility into

the Medicare and Medicaid EHR Incentive Programs, and add overall value and 

consistency by providing us the opportunity to address public comments that affect 

multiple programs at one time. We propose to continue to support active communication 

with providers to facilitate the sharing of information related to CQM selection and 

reporting, the announcement of opportunities for public comment on CQM selection and 
CMS-3310-P 163

reporting, and upcoming or relevant CQM program milestones in partnership with state 

Medicaid programs and the Medicare quality reporting programs. We propose to 

continue to post the defined CQM sets and the published electronic specifications for 

CQM that are in use for all aligned programs on the CMS website as currently posted on 

the eCQM Library page: http://www.cms.gov/Regulations-andGuidance/Legislation/EHRIncentivePrograms/eCQM_Library.html.

2. CQM Reporting Period

In the Stage 2 final rule, we finalized a reporting period for CQMs for EPs, 

eligible hospitals, and CAHs (see 77 FR 54049 through 54051). In the FY 2015 IPPS 

final rule, we began to shift CQM reporting to a calendar year basis for eligible hospitals 

and CAHs for the Medicare EHR Incentive Program (79 FR 50319 through 50321). We 

established that for eligible hospitals and CAHs that submit CQMs electronically in 2015, 

the reporting period is one calendar quarter from Q1, Q2, or Q3 of CY 2015

(79 FR 50321).

As discussed in sections II.A.1.c.(1).(b).(i). and II.F. of this proposed rule, we are 

proposing to require an EHR reporting period of 1 full calendar year for meaningful use 

for providers participating in the Medicare EHR Incentive Program, with a limited 

exception for Medicaid providers demonstrating meaningful use for the first time. We 

are proposing to require the same length for the CQM reporting period for EPs, eligible 

hospitals, and CAHs beginning in 2017. As noted, we are proposing a limited exception 

for Medicaid providers demonstrating meaningful use for the first time who would have a 

CQM reporting period of any continuous 90 days that is the same 90-day period as their 
CMS-3310-P 164

EHR Reporting Period.

We believe full year reporting would allow for the collection of more comparable 

data across CMS quality programs and increase alignment across those programs. The 

more robust data set provided by a full year reporting period offers more opportunity for 

alignment than the data set provided by a shorter reporting period, especially compared 

across years. We further believe this full calendar year reporting period for CQMs would

reduce the complexity of reporting requirements for the Medicare EHR Incentive 

Program by streamlining the reporting timeline for providers for CQMs and meaningful 

use objectives and measures. We welcome comment on the following proposals. 

a. CQM Reporting Period for EPs

With the previously stated considerations in mind, and in an effort to align with 

other CMS quality reporting programs such as the PQRS, we propose to require for CQM 

reporting under the EHR Incentive Program a reporting period of one full calendar year

for all EPs participating in the Medicare and Medicaid EHR Incentive Program, with a 

limited exception for Medicaid providers demonstrating meaningful use for the first time 

who would have a CQM reporting period of any continuous 90 days that is the same 

90-day period as their EHR Reporting Period. These reporting periods would apply 

beginning in CY 2017 for all EPs participating in the EHR Incentive Program. 

b. CQM Reporting Period for Eligible Hospital/CAH 

For eligible hospitals and CAHs in 2017 and subsequent years, we are proposing 

to require a reporting period of 1 full calendar year which consists of 4 quarterly data 

reporting periods for providers participating in the Medicare and Medicaid EHR 
CMS-3310-P 165

Incentive Program, with a limited exception for Medicaid providers demonstrating 

meaningful use for the first time who would have a CQM reporting period of any 

continuous 90 days that is the same 90-day period as their EHR Reporting Period. More 

details of the form and manner will be provided in the IPPS rulemaking cycle.

c. Reporting Flexibility EPs, Eligible Hospitals, CAHs 2017

In order to align with the flexibility option of participation in Meaningful Use in 

2017 (see section II.C.1.b. of this proposed rule), we are proposing that EPs, eligible 

hospitals, and CAHs would be able to have more flexibility to report CQMs in one of two 

ways in 2017 – via electronic reporting or attestation. First EPs, eligible hospitals, and 

CAHs may choose to report eCQMs electronically using the CQMs finalized for use in 

2017 using the most recent version of the eCQMs (electronic specifications), which 

would be the electronic specifications of the CQMs published by CMS in 2016. 

Alternately, a provider may choose to continue to attest also using the most recent (2016

version) eCQM electronic specifications. We note that the intent to allow attestation in 

2017 is to provide flexibility for providers transitioning between versions of CEHRT in 

2017 and believe that requiring the most recent version of the annual updates should not 

be a significant burden given that developers do not need to recertify a product each time 

CQM specifications are updated. However, we seek comment on if CMS should 

consider allowing providers to report using another earlier version of the specifications. 

We note that, unlike the flexible options established in rulemaking in 2014 

(79 FR 52927 through 52930), providers may select the CQMs they choose to report 

separately from the Stage objectives and measures of meaningful use for their EHR 
CMS-3310-P 166

reporting period in 2017. 

We invite public comment on our proposals.

3. Reporting Methods for CQMs 

In the Stage 2 final rule, we finalized the reporting methods for CQMs for EPs

(77 FR 54075 through 54078), eligible hospitals, and CAHs (77 FR 54087 through 

54089) for the Medicare EHR Incentive Program, which included reporting 

electronically, where feasible, or by attestation. To further align the Medicare and 

Medicaid EHR Incentive Programs with programs such as PQRS and the Hospital IQR 

program, starting in 2017, we propose to continue to encourage electronic submission of 

CQM data for all EPs, eligible hospitals, and CAHs where feasible; however, as outlined 

in section II.C.1.b. of this proposed rule, we would allow attestation for CQMs in 2017. 

For 2018 and subsequent years, we are proposing that providers participating in the 

Medicare program must electronically report where feasible and that attestation to CQMs 

would no longer be an option except in certain circumstances where electronic reporting 

is not feasible. This would include providers facing circumstances which render them 

unable to electronically report (such as a data submission system failure, natural disaster, 

or certification issue outside the control of the provider) who may attest to CQMs if they 

also attest that electronically reporting was not feasible for their demonstration of 

meaningful use for a given year. We believe that the collection and electronic reporting 

of data through health information technology would greatly simplify and streamline 

reporting for many CMS quality reporting programs and reduce the burden of quality 

measure reporting for providers who participate in these programs. We also believe this 
CMS-3310-P 167

would further encourage the adoption and use of certified EHR technology by allowing 

EPs, eligible hospitals, and CAHs to report data for multiple programs through a single 

electronic submission. Through electronic reporting, EPs, eligible hospitals, and CAHs 

would be able to leverage EHRs to capture, calculate, and electronically submit quality 

data to CMS for the Medicare EHR Incentive Program. We note that we intend to 

address the form and manner of electronic reporting in future Medicare payment rules.

For the Medicaid EHR Incentive Program, as in the Stage 2 rulemaking 

(77 FR 54089), we propose that states would continue in Stage 3 to be responsible for 

determining whether and how electronic reporting of CQMs would occur, or whether

they wish to continue to allow reporting through attestation. If a state does require such 

electronic reporting, the state is responsible for sharing the details of the process with its 

provider community. We anticipate that whatever means states have deployed for 

capturing CQMs electronically for Stages 1 and 2 would be similar for reporting in 

Stage 3. However, we note that subject to our prior approval, this is within the states'

purview. We propose for Stage 3 that the states would establish the method and 

requirements, subject to our prior approval, for the electronic capture and reporting of 

CQMs from CEHRT.
CMS-3310-P 168

Proposed eCQM Reporting Timelines for Medicare & Medicaid EHR Incentive 

Program

Year 2017 only 2017 only 2018 and subsequent 

years

2018 and subsequent 

years

Reporting Method 

Available

Attestation Electronic Reporting Attestation Electronic Reporting

Provider Type who 

May Use Method

All Medicare 

providers

Medicaid providers 

must refer to state 

requirements for 

reporting

All Medicare 

Providers

Medicaid providers 

must refer to state 

requirements for 

reporting

Medicare Providers 

with circumstances 

rendering them 

unable to eReport

Medicaid providers 

must refer to state 

requirements for 

reporting

All Medicare 

Providers

Medicaid providers 

must refer to state 

requirements for 

reporting

CQM Reporting 

Period

1 CY for Medicare

1 CY for returning 

Medicaid

90 days for first time 

meaningful user 

Medicaid

1 CY for Medicare

1 CY for returning 

Medicaid

90 days for first time 

meaningful user 

Medicaid

1 CY for Medicare

1 CY for returning 

Medicaid

90 days for first time 

meaningful user 

Medicaid

1 CY for Medicare

1 CY for returning 

Medicaid

90 days for first time 

meaningful user 

Medicaid

eCQM Version 

Required 

(CQM electronic 

specifications 

update) 

2016 Annual Update 2016 Annual Update 2016 Annual Update 

or more recent 

version

2017 Annual Update

CEHRT Edition 

Required

2014 Edition 

Or

2015 Edition

2014 Edition 

Or

2015 Edition

2015 Edition 2015 Edition

We invite public comments on our proposals.

a. Quality Reporting Data Architecture Category III (QRDA-III) Option for Eligible 

Hospitals and CAHs

In the Stage 2 final rule (77 FR 54088), we finalized two options for eligible 

hospitals and CAHs to electronically submit CQMs beginning in FY 2014 under the 

Medicare EHR Incentive Program. Option 1 was to submit aggregate level CQM data 

using QRDA-III electronically. Option 2 was to submit data electronically using a 

method similar to the 2012 and 2013 Medicare EHR Incentive Program electronic 

reporting pilot for eligible hospitals and CAHs, which used QRDA-I (patient-level data). 
CMS-3310-P 169

We noted in the FY 2014 and 2015 IPPS/LTCH PPS final rules (78 FR 50904 

through 50905 and 79 FR 50321 through 50322) that we had determined that the 

electronic submission of aggregate-level data using QRDA-III would not be feasible in 

2014 or 2015 for eligible hospitals and CAHs under the Medicare EHR Incentive 

Program. We stated that we would reassess this policy for future reporting periods. 

In this proposed rule, we are proposing to remove the QRDA-III option for 

eligible hospitals and CAHs, as we have found this is not an option for electronic 

reporting as we move forward with the EHR Incentive Program, we believe the 

calculations, per the QRDA-III, are not advantageous to quality improvement. As the 

EHR Incentive Program further aligns with the Hospital IQR program, we intend to 

continue utilizing the electronic reporting standard of QRDA-I patient level data that we 

finalized in the FY 2015 IPPS rule (79 FR 50322), which will allow the same level of 

CQM reporting, and use and analysis of these data for quality improvement initiatives. 

As we understand the need to support state flexibility, we are also proposing that 

states would continue to have the option, subject to our prior approval, to allow or require 

QRDA-III for CQM reporting. 

4. CQM Specification and Changes to the Annual Update

In the Stage 2 final rule, we stated that we do not intend to use notice and 

comment rulemaking as a means to update or modify electronic CQM (eCQM) 

specifications (77 FR 54055). In general, it is the role of the measure steward to make 

changes to a CQM in terms of the initial patient population, numerator, denominator, 

potential exclusions, logic, and value sets. We recognize that it may be necessary to 
CMS-3310-P 170

update CQM specifications after they have been published to ensure their continued 

clinical relevance, accuracy, and validity. CQM specification updates may include 

administrative changes, such as adding the NQF endorsement number to a CQM, 

correcting faulty logic, adding or deleting codes as well as providing additional 

implementation guidance for a CQM. 

These changes are described through the annual updates to the electronic 

specifications for EHR submission published by CMS. CQMs are currently tracked on a 

version basis as updates are made and we require EPs, eligible hospitals, and CAHs to 

submit the versions of the CQMs as identified on our website. The website contains all 

versions of the CQMs since reporting via attestation does not require the most recent 

version of the CQMs, but electronic reporting of the CQMs does require the most recent 

version to be reported. Because we require the most recent version of the CQM 

specifications to be used for electronic reporting methods, we understand that EHR 

vendors must make CQM updates on an annual basis. We also understand that providers 

must regularly implement those updates to stay current with the most recent CQM

version. 

We continue to evaluate the CQM update timeline and look for ways to provide 

CQM updates timely, so that vendors can develop, test, and deploy these updates and 

providers can implement those updates as necessary. We have the flexibility to update 

CQMs so they remain clinically relevant, accurate, and valid. While we are not 

proposing any change to our policy on updating CQM specifications in this proposed 

rule, we seek comment on our annual update timeline and suggestions for how to 
CMS-3310-P 171

improve the CQM update process. 

5. EHR Technology Certification Requirements for Reporting of CQMs

In the 2014 Edition EHR Certification Criteria Final Rule, ONC finalized certain 

certification criteria to support the MU objectives and CQMs set forth by CMS. In that 

rule, ONC also specified that in order for an EP, eligible hospital, or CAH to have EHR 

technology that meets the Base EHR definition, the EHR technology must be certified to 

a minimum of nine CQMs for EPs or 16 CQMs for eligible hospitals and CAHs

(77 FR 54264 through 54265; see also 45 CFR 170.102). This is the same number 

required for quality reporting to the Medicare and Medicaid EHR Incentive Programs, the

PQRS EHR reporting and, beginning in 2015, the electronic reporting option under the 

Hospital IQR Program. In certain cases, an EP, eligible hospital or CAH may purchase 

an EHR product that is certified to the minimum number of CQMs and discover that, for 

at least one of those CQMs, they do not have data on which to report. In these cases, the 

EP (77 FR 54058 through 54059), eligible hospital or CAH (77 FR 54051) would report a 

zero denominator for one or more CQMs.

We believe EHRs should be certified to more than the minimum number of 

CQMs required by one or more CMS quality reporting programs so that EPs, eligible 

hospitals, and CAHs have a choice of which CQMs to report, and could therefore choose 

to report on CQMs most applicable to their patient population or scope of practice. 

We realize that requiring EHRs to be certified to more than the minimum number 

of CQMs required by the Medicare and Medicaid EHR Incentive Programs may increase 

the burden on EHR vendors. However, in the interest of EPs, eligible hospitals, and 
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CAHs being able to choose to report eCQMs that represent their patient populations, we 

would like to see EP vendors certify to all eCQMs that are in the EP selection list, or 

eligible hospital/CAH vendors certify to all eCQMs in the selection list for those 

stakeholders. 

We are also considering a phased approach such that the number of CQMs 

required for the vendors to have certified would increase each year until EHR products 

are required to certify all CQMs required for reporting by EPs, eligible hospitals, and 

CAHs. For example, in year one of this phased plan, we might require that EHRs be 

certified to at least 18 of 64 available CQMs for EPs and 22 of 29 available CQMs for 

eligible hospitals and CAHs; in year two, we might require at least 36 CQMs for EPs and 

all 29 CQMs for eligible hospitals and CAHs; in subsequent years of the plan, we would 

increase the number of required CQMs for EPs until the EHR is certified to all applicable 

CQMs for EPs, eligible hospitals, and CAHs.

We have also considered alternate plans that would require EHRs to be certified 

to more than the minimum number of CQMs required for reporting, but would not 

require the EHR to be certified to all available CQMs. For example, we might require 

that EHRs be certified to a certain core set of CQMs plus an additional 9 CQMs for EPs, 

and a certain core set of CQMs plus an additional 16 CQMs for eligible hospitals and 

CAHs, which the EHR vendor could choose from the list of available CQMs. 

We note that the specifics of this plan would be outlined in separate 

notice-and-comment rulemaking such as the PFS or IPPS rules. We specifically seek 

comment on this issue of a plan to increase the number of CQMs to which an EHR is 
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certified.

6. Electronic Reporting of CQMs

As previously stated in the Medicare and Medicaid EHR Incentive Programs

Stage 2 final rule (77 FR 54051 through 54053), CQM data submitted by EPs, eligible 

hospitals, and CAHs are required to be captured, calculated and reported using certified 

EHR technology. We received numerous questions from stakeholders expressing 

confusion over what it means to capture data in certified EHR technology. Specifically, 

stakeholders question whether they may manually abstract data into the EHR from a 

patient's chart. We do not consider the manual abstraction of data from the EHR to be

capturing the data using certified EHR technology. We believe that electronic 

information interfaced or electronically transmitted from non-certified EHR technology, 

such as lab information systems, automated blood pressure cuffs, and electronic scales, 

into the certified EHR, would satisfy the "capture" requirement, as long as that data is 

visible to providers in the EHR. 
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C. Demonstration of Meaningful Use and Other Issues

1. Demonstration of Meaningful Use

a. Common Methods of Demonstration in Medicare and Medicaid

We are proposing to continue our common method for demonstrating meaningful 

use in both the Medicare and Medicaid EHR Incentive Programs. The demonstration 

methods we adopt for Medicare would automatically be available to the States for use in 

their Medicaid programs. 

b. Methods for Demonstration of the Stage 3 Criteria of Meaningful Use for 2017 and 

Subsequent Years

We are proposing to continue the use of attestation as the method for 

demonstrating that an EP, eligible hospital, or CAH has met the Stage 3 objectives and 

measures of meaningful use. We are proposing to continue the existing optional batch 

file process for attestation in lieu of individual Medicare EP attestation through our

registration and attestion system. This batch reporting process ensures that meaningful 

use of certified EHR technology continues to be measured at the individual level, while 

promoting efficiencies for group practices that must submit attestations on large groups 

of individuals (77 FR 54089). 

We would continue to leave open the possibility for CMS and the states to test 

options for demonstrating meaningful use that utilize existing and emerging HIT products 

and infrastructure capabilities. These options could involve the use of registries or the 

direct electronic reporting of measures associated with the objectives of meaningful use. 
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We would not require any EP, eligible hospital, or CAH to participate in this testing in 

order to receive an incentive payment or avoid the payment adjustment. 

For 2017 only, we are proposing changes to the attestation process for the 

meaningful use objectives and measures, which would allow flexibility for providers 

during this transitional year. These proposals are supported by a similar flexibility 

proposed in the requirements for the Edition of CEHRT a provider may use in 2017 as 

further discussed in section II.A.I.C.(1).(b).(3). of this proposed rule. In addition, we 

discuss the attestation changes proposed for CQM reporting in detail under section 

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

(1) Meaningful Use Objective and Measures in 2017

In order to allow all providers to successfully transition to Stage 3 of meaningful 

use for a full year-long EHR reporting period in 2018, we are proposing to allow 

flexibility for the EHR Incentive Programs in 2017. This transition period would allow 

providers to establish and test their processes and workflows for Stage 3 of meaningful 

use prior to 2018. Specifically, for 2017, we are proposing that providers may either

repeat a year at their current stage or move up stage levels. However, for 2017, a 

provider may not move backward in their progression. Under this proposal, providers

who participated in Stage 1 in 2016 may choose to attest to the Stage 1 objective and 

measures, or they may move on to Stage 2 or Stage 3 objectives and measures for an 

EHR reporting period in 2017. Providers who participated in Stage 2 in 2016 may 

choose to attest to the Stage 2 objectives and measures or move on to Stage 3 objectives 

and measures for an EHR reporting period in 2017. However, under no circumstances, 
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may providers return to Stage 1. In 2018, all providers, regardless of their prior 

participation or the stage level chosen in 2017, would be required to attest to Stage 3 

objectives and measures for an EHR reporting period in 2018. 

(2) CEHRT and Stage Flexibility in 2017

Based on the delays providers experienced with fully implementing the EHR 

technology certified to the 2014 Edition (as further described in the 2014 CEHRT 

Flexibility final rule (79 FR 52910 through 52933) we believe it is necessary to 

preemptively prepare for the upgrade to EHR technology certified to the 2015 Edition

and the transition to Stage 3. Preparation for the upgrade would ensure that providers and 

developers have adequate time to certify, install, fully implement the software, and 

establish the processes and workflows for the objectives and measures for providers 

moving to the next stage of the EHR Incentive Programs. Accordingly, we propose 

allowing providers flexible CEHRT options for 2017. These options may impact the 

selection of objectives and measures to which a provider can attest. Specifically, under 

the CEHRT options for 2017, we propose that providers would have the option to 

continue to use EHR technology certified to the 2014 Edition, in whole or in part, for an 

EHR reporting period in 2017. We note that providers who use only the EHR technology 

certified to the 2014 Edition for an EHR reporting period in 2017 may not choose to 

attest to the Stage 3 objectives and measures as those objectives and measures require the 

support of EHR technology certified to the 2015 Edition.
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Providers using only EHR technology certified in whole or in relevant part to the

2014 Edition certification criteria may attest to the objectives and measures of 

meaningful use in the following manner: 

 If a provider first demonstrated meaningful use in 2015 or 2016, they may 

attest to Stage 1 objectives and measures or Stage 2 objectives and measures.

 If a provider first demonstrated meaningful use in any year prior to 2015, they 

may attest to the Stage 2 objectives and measures. 

Providers using EHR technology certified in whole or in relevant part to the

2015 Edition certification criteria may elect to attest to the objectives and measures of 

meaningful use in the following manner:

 If a provider first demonstrated meaningful use in 2015 or 2016, they may 

attest to Stage 1 objectives and measures, Stage 2 objectives and measures, or Stage 3 

objectives and measures if they have all the 2015 Edition functionality required to meet 

all Stage 3 objectives. 

 If a provider first demonstrated meaningful use in any year prior to 2015, they 

may attest to Stage 2 objectives and measures, or Stage 3 objectives and measures if they 

have all the 2015 Edition functionality required to meet all Stage 3 objectives.

We note that all providers would be required to fully upgrade to EHR technology 

certified to the 2015 Edition for the EHR reporting period in 2018. We also reiterate that 

providers may elect to attest to Stage 3 of the program using EHR technology certified to 

the 2015 Edition beginning in 2017. We further stress that the use of 2011 CEHRT, 

although an option under the 2014 CEHRT Flexibility final rule (79 FR 52913 through 
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52914), is not an option under this proposal. However, as part of this proposal, we would 

like to seek comment on alternate flexibility options. Specifically, we are seeking 

comment on whether the flexible option to attest to Stages 1 or 2 should be limited to

only those providers who could not fully implement EHR technology certified to the 

2015 Edition in 2017. We are also seeking comment on whether those providers with 

fully implemented EHR technology certified to the 2015 Edition in 2017 should be 

required to attest to Stage 3 only in 2017. Finally, we seek comment on whether 

providers should not have the option to attest to Stage 3 in 2017 regardless of an upgrade 

to EHR technology certified to the 2015 Edition in 2017, and should instead be required 

to wait to demonstrate Stage 3 until 2018 using EHR technology certified to the 2015 

Edition. 

We welcome comments on these proposals. 

(3) CQM Flexibility in 2017

In the 2014 CEHRT Flexibility final rule, we did not allow providers to separate 

their CQM reporting selection from the year of meaningful use objectives they reported 

on. We did not allow this reporting for a number of reasons including how we defined 

CQMs, as well as the number of CQMs reporting changes occurring between Stage 1 in 

2011 through 2013, and Stage 1 and 2 in 2014. For further discussion, we direct readers 

to 79 FR 52927 through 52930. 

To report CQMs for 2017, we propose to allow greater flexibility by proposing to 

split the use of CEHRT for CQM reporting from the use of CEHRT for the objectives and 

measures. This means that providers would be able to separately report CQMs using 
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EHR technology certified to the 2015 Edition even if they use EHR technology certified 

to the 2014 Edition for the meaningful use objectives and measures for an EHR reporting 

period in 2017. Providers may also use EHR technology certified to the 2015 Edition for 

their meaningful use objectives and measures in 2017 and use EHR technology certified 

to the 2014 Edition for their CQM reporting for an EHR reporting period in 2017. 

For an EHR reporting period in 2017, EPs, eligible hospitals, and CAHs may 

choose to report eCQMs electronically using the CQMs finalized for use in 2017 using 

the most recent version of the eCQMs (electronic specifications), which would be the 

electronic specifications of the CQMs published by CMS in 2016. Alternately, a 

provider may choose to continue to attest to the CQMs established for use in 2017 also 

using the most recent (2016 version) eCQM electronic specifications. These options are 

available for provider using either EHR technology certified to the 2014 Edition or EHR 

technology certified to the 2015 Edition. These flexible options for an EHR reporting 

period in 2017 are further discussed in sections II.B.2.a. of this proposed rule. An EP, 

eligible hospital, or CAH must use certified EHR technology, successfully attest to the 

meaningful use objectives and measures, and successfully submit CQMs to be a 

meaningful EHR user. We note that states may determine the form and method of CQM 

submission for participants in the Medicaid program subject to our approval as outline in 

sections II.B.3 and II.F.3. of this proposed rule. However, the selection of CQMs and the 

minimum reporting period are the same for providers in both Medicare and Medicaid as 

outlined in section II.B.3. of this proposed rule.
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Similar to our rationale under the 2014 CEHRT Flexibility final rule

(79 FR 52910 through 52933), we believe the proposals outlined for attestation in 2017 

would allow providers the flexibility to choose the option which applies to their particular 

circumstances and use of CEHRT. Upon attestation, providers may select one of the 

proposed options available for their participation year and EHR Edition. The EHR 

Incentive Program Registration and Attestation System would then prompt the provider 

to attest to meeting the objectives, measures, and CQMs applicable under that option. 

We further propose that auditors would be provided guidance related to reviewing 

attestations associated with the options for using CEHRT in 2017, as was done for 2014. 

We welcome comment on this proposal. 

c. EHR Reporting Period in 2017 and Subsequent Years

We are proposing, with limited exceptions outlined in section II.F.1. of this 

proposed rule, that the EHR reporting period in 2017 would be a full calendar year for all 

providers. We encourage providers to begin Stage 3 in 2017. However, under the 

current timeline shown in Table 3, we recognize that providers first demonstrating

meaningful use under Stage 1 in 2016 or 2017 or under Stage 2 in 2016 or 2017 must 

begin Stage 3 in 2018. We further recognize providers scheduled to begin Stage 3 in 

2017 that instead choose to meet the Stage 2 criteria in 2017 must begin Stage 3 in 2018. 

However, in 2018, all providers, except as outlined in section II.F.1. of this proposed 

rule, must report based on a full calendar year EHR reporting period for the Stage 3 

objectives and measures. In addition, in 2018, all providers must use EHR technology 

certified to the 2015 Edition for the full EHR reporting period in order to successfully 
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demonstrate meaningful use. 

For CQM reporting in 2018 and subsequent years, as outlined in section II.B.3 of 

this proposed rule, we are proposing that providers participating in the Medicare program 

must electronically report, where feasible, and that attestation to CQMs would no longer 

be an option except in circumstances where electronic reporting is not feasible. This 

would include providers facing circumstances which render them unable to electronically 

report (such as a data submission system failure, natural disaster, or certification issue 

outside the control of the provider) who may attest to CQMs if they also attest that 

electronically reporting was not feasible for their demonstration of meaningful use for a 

given year.

We welcome public comment on this proposal. 

2. Data Collection for Online Posting, Program Coordination, and Accurate Payments

We propose to continue posting Stage 1 and Stage 2 aggregate and individual 

performance and participation data resulting from the EHR Incentive programs online 

regularly for public use. We further note our intent to potentially publish the 

performance and participation data on Stage 3 objectives and measures of meaningful use 

in alignment with quality programs which utilize publicly available performance data

such as physician compare. 

In addition to the data already being collected under our regulations, as outlined in 

section III. of this proposed rule, we propose to collect the following information from 

providers to ensure providers keep their information up-to-date through the system of 

record for their National Provider Identifier (NPI) in the National Plan & Provider 
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Enumeration System: 

 Primary Practice Address (address, city, state zip, country code, etc.).

 Primary Business/Billing Address (address, city, state, zip, country code, etc.).

 Primary License information (for example, provide medical license in at least 

one state (or territory)).

 Contact Information (phone number, fax number, and contact email address).

 Health Information Exchange Information: 

++ Such as DIRECT address required (if available).

++ If DIRECT address is not available, Electronic Service Information is 

required.

++ If DIRECT address is available, Electronic Service Information is optional in 

addition to DIRECT address. 

We do not propose any changes to the registration for the Medicare and Medicaid 

EHR Incentive Programs.

3. Interaction with Other Programs

There are no proposed changes to the ability of providers to participate in the 

Medicare and Medicaid EHR Incentive Programs and other CMS programs. We 

continue to work on aligning the data collection and reporting of the various CMS 

programs, especially in the area of clinical quality measurement. See sections II.B.1. 

through II.B.6. of this proposed rule for the proposed alignment initiatives for CQMs.
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D. Payment Adjustments and Hardship Exceptions

Sections 4101(b) and 4102(b) of the HITECH Act, amending sections 1848, 1853, 

and 1886 of the Act, require reductions in payments to EPs, eligible hospitals, and CAHs 

that are not meaningful users of certified EHR technology, beginning in CY 2015 for 

EPs, FY 2015 for eligible hospitals, and in cost reporting periods beginning in FY 2015 

for CAHs. 

1. Statutory Basis for Payment Adjustment and Hardship Exceptions for EPs

Section 1848(a)(7) of the Act provides for payment adjustments, effective for 

CY 2015 and subsequent years, for EPs as defined in 42 CFR 495.100, who are not 

meaningful EHR users during the relevant EHR reporting period for the year. Section 

1848(a)(7) provides that in general, beginning in 2015, if an EP is not a meaningful EHR 

user for the EHR reporting period for the year, then the Medicare physician fee schedule 

(PFS) amount for covered professional services furnished by the EP during the year 

(including the fee schedule amount for purposes of determining a payment based on the 

fee schedule amount) is adjusted to equal the "applicable percent" of the fee schedule 

amount that would otherwise apply. The term "applicable percent" is defined in section 

1848(a)(7)(A)(ii) of the Act as: (I) for 2015, 99 percent (or, in the case of an EP who was 

subject to the application of the payment adjustment [if the EP was not a successful 

electronic prescriber] under section 1848(a)(5) of the Act for 2014, 98 percent); (II) for 

2016, 98 percent; and (III) for 2017 and each subsequent year, 97 percent. 

In addition, section 1848(a)(7)(A)(iii) of the Act provides that if, for CY 2018 and 

subsequent years, the Secretary finds the proportion of EPs who are meaningful EHR 
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users is less than 75 percent, the applicable percent shall be decreased by 1 percentage 

point for EPs who are not meaningful EHR users from the applicable percent in the 

preceding year, but that in no case shall the applicable percent be less than 95 percent. 

Section 1848(a)(7)(B) of the Act provides that the Secretary may, on a 

case-by-case basis, exempt an EP who is not a meaningful EHR user for the reporting 

period for the year from the application of the payment adjustment if the Secretary 

determines that compliance with the requirements for being a meaningful EHR user 

would result in a significant hardship, such as in the case of an EP who practices in a 

rural area without sufficient internet access. The exception is subject to annual renewal, 

but in no case may an EP be granted an exception for more than 5 years. 

We established regulations implementing these statutory provisions under 

42 CFR 495.102. We refer readers to the final rules for Stages 1 and 2 (75 FR 44442 

through 44448 and 77 FR 54093 through 54102) for more information. 

2. EHR Reporting Period for Determining whether an EP is Subject to the Payment 

Adjustment for CY 2018 and Subsequent Calendar Years

Section 1848(a)(7)(E)(ii) of the Act provides the Secretary with broad authority to 

choose the EHR reporting period that will apply for purposes of determining the payment 

adjustments for CY 2015 and subsequent years. In the Stage 2 final rule (77 FR 54095 

through 54097), we adopted a policy that the EHR reporting periods for the payment 

adjustments will begin and end prior to the year of the payment adjustment. We stated 

that this is based on our desire to avoid creating a situation in which it might be necessary 

either to recoup overpayments or make additional payments after a determination is made 
CMS-3310-P 185

about whether the payment adjustment should apply, and the resulting implications for 

beneficiary coinsurance. 

Specifically, we finalized under § 495.4 of the regulations that for EPs, the EHR 

reporting period for a payment adjustment year is the full calendar year that is 2 years 

before the payment adjustment year. For example, the full calendar year of 2015 would 

be the EHR reporting period for the CY 2017 payment adjustment year. We also 

finalized an exception to this rule for EPs who have never successfully attested to 

meaningful use. Stated generally, under this exception, for an EP who is demonstrating 

meaningful use for the first time, the EHR reporting period for a payment adjustment 

year is any continuous 90-day period. For a full description of this exception, including 

limitations on when the continuous 90-day period must occur in relation to the payment 

adjustment year and the deadlines for registration and attestation, we refer readers to the 

definition of "EHR reporting period for a payment adjustment year" under § 495.4 of the 

regulations and the discussion in the Stage 2 final rule (77 FR 54095 through 54096). 

We established that these policies apply for the CY 2015 payment adjustment year and 

subsequent payment adjustment years. 

However, in this Stage 3 proposed rule, we propose to eliminate the exception 

discussed previously for a 90-day EHR reporting period for new meaningful EHR users 

beginning with the EHR reporting period in 2017, with a limited exception for Medicaid 

EPs demonstrating meaningful use for the first time. We propose that for EPs who have 

successfully demonstrated meaningful use in a prior year as well as those who have not, 

the EHR reporting period for a payment adjustment year would be the full calendar year 
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that is 2 years before the payment adjustment year. For example, for all EPs

demonstrating meaningful use, the full CY 2017 would be the EHR reporting period for 

the CY 2019 payment adjustment year. To avoid a payment adjustment in CY 2019, EPs 

must demonstrate meaningful use of certified EHR technology for an EHR reporting 

period of the entire CY 2017. This policy would continue to apply in subsequent years. 

As discussed in sections II.A.1.a. and II.F.1. of this proposed rule, we are 

proposing to maintain a 90-day EHR reporting period for the first payment year based on 

meaningful use for Medicaid EPs demonstrating meaningful use for the first time. We 

recognize that these EPs may be subject to payment adjustments under Medicare if they 

fail to demonstrate meaningful use, and thus we propose that the same 90-day EHR 

reporting period used for the Medicaid incentive payment would also apply for purposes 

of the Medicare payment adjustment for the payment adjustment year two years after the 

calendar year in which the provider demonstrates meaningful use. We note under our 

current policy, if an EP has never successfully demonstrated meaningful use, the EHR 

reporting period for a payment adjustment year is any continuous 90-day period that both 

begins in the calendar year 1 year before the payment adjustment year and ends at least 

3 months before the end of such prior year. We do not propose to maintain this policy, 

and thus for Medicaid EPs who are new meaningful EHR users, the 90-day EHR 

reporting period for a payment adjustment year must occur within the calendar year that 

is 2 years before the payment adjustment year. These proposals for Medicaid EPs would 

apply beginning with the EHR reporting period in CY 2017.

We provide the following example: 
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Example A: If an EP has never successfully demonstrated meaningful use prior 

to CY 2017 and demonstrates under the Medicaid EHR Incentive Program that he or she 

is a meaningful EHR user for the first time in CY 2017, the EHR reporting period for the 

Medicaid incentive payment would be any continuous 90-day period within CY 2017. 

The same 90-day period would also serve as the EHR reporting period for the CY 2019 

payment adjustment year under Medicare. This 90-day period would not serve as the 

EHR reporting period for the CY 2018 payment adjustment year under Medicare even if 

the EP registers for and attests to meaningful use by October 1, 2017. The EP would 

have to demonstrate meaningful use for an EHR reporting period of the full CY 2018 to 

earn an incentive payment under Medicaid for the CY 2018 payment year and avoid the 

payment adjustment under Medicare for the CY 2020 payment adjustment year. 

We propose these changes to further our goal to align reporting requirements 

under the EHR Incentive Program and the reporting requirements for various CMS 

quality reporting programs, to respond to stakeholders who cited difficulty with following 

varying reporting requirements, and to simplify HHS system requirements for data 

capture. We further note that newly practicing EPs have the ability to apply for a 

hardship exception from the Secretary under § 495.102(d)(4)(ii), which provides for an 

exception from the payment adjustments for the 2 years after they begin practicing. We 

propose amendments to the definition of "EHR reporting period for a payment 

adjustment year" under § 495.4 to reflect these proposals. We welcome public comments 

on this proposal. 

3. Exception to the Application of the Payment Adjustment to EPs in CY 2017 and 
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Subsequent Years

As previously discussed, sections 1848(a)(7)(B) of the Act provides that the 

Secretary may, on a case-by-case basis, exempt an EP from the application of the 

payment adjustment in CY 2015 and subsequent calendar years if the Secretary 

determines that compliance with the requirements for being a meaningful EHR user will

result in a significant hardship, such as an EP who practices in a rural area without 

sufficient internet access. As provided by the statute, the exception is subject to annual 

renewal, but in no case may an EP be granted an exception for more than 5 years. The 

statute does not require the Secretary to grant exceptions. However, as we stated in the 

Stage 2 final rule at 77 FR 54097, we believe that certain circumstances evidence the 

existence of a hardship, thereby justifying the need for an exception by the Secretary. 

Therefore, in the Stage 2 final rule, we finalized various types of hardship exceptions that 

EPs could apply for, which included insufficient internet access, newly practicing EPs, 

extreme circumstances outside of an EP's control, lack of control over the availability of 

CEHRT for EPs practicing in multiple locations, lack of face-to-face patient interactions 

and lack of need for follow-up care, and certain primary specialties. For further 

discussion of the hardship exceptions, we refer readers to the Stage 2 final rule at 

77 FR 54097 through 54101 and 42 CFR 495.102(d)(4). 

In this Stage 3 proposed rule, we propose no changes to the types of exceptions 

previously finalized for EPs, nor do we propose any new types of exceptions for 2017 

and subsequent years. Accordingly, we propose that the exceptions continue as 

previously finalized. 
CMS-3310-P 189

4. Statutory Basis for Payment Adjustments and Hardship Exceptions for Eligible 

Hospitals

Section 1886(b)(3)(B)(ix)(I) of the Act, as amended by section 4102(b)(1) of the 

HITECH Act, provides for an adjustment to the applicable percentage increase to the 

IPPS payment rate for those eligible hospitals that are not meaningful EHR users for the 

associated EHR reporting period for a payment adjustment year, beginning in FY 2015. 

Specifically, section 1886(b)(3)(B)(ix)(I) of the Act provides that, for FY 2015 and each 

subsequent fiscal year, an eligible hospital that is not "a meaningful EHR user . . . for an 

EHR reporting period" will receive a reduced update to the IPPS standardized amount. 

This reduction applies to "three-quarters of the percentage increase otherwise applicable"

prior to the application of statutory adjustments under sections 1886(b)(3)(B)(viii), 

1886(b)(3)(B)(xi), and 1886(b)(3)(B)(xii) of the Act, or three-quarters of the applicable 

market basket update. The reduction to three-quarters of the applicable update for an 

eligible hospital that is not a meaningful EHR user will be "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 fiscal year involved and the Secretary shall 

not take into account such reduction in computing the applicable percentage increase for 
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a subsequent fiscal year. 

Section 1886(b)(3)(B)(ix)(II) of the Act, as amended by Section 4102(b)(1) of the 

HITECH Act, provides that the Secretary may, on a case-by-case basis, exempt a hospital 

from the application of the applicable percentage increase adjustment for a fiscal year if 

the Secretary determines that requiring such hospital to be a meaningful EHR user will 

result in a significant hardship, such as in the case of a hospital in a rural area without 

sufficient internet access. This section also provides that such determinations are subject 

to annual renewal, and that in no case may a hospital be granted an exception for more 

than 5 years. 

5. Applicable Market Basket Update Adjustment for Eligible Hospitals that are not 

Meaningful EHR Users for FY 2019 and Subsequent Fiscal Years

Section 412.64(d) of the regulations sets forth the adjustment to the percentage 

increase in the market basket index for those eligible hospitals that are not meaningful 

EHR users for the EHR reporting period for a payment year, beginning in FY 2015. 

6. EHR Reporting Period for Determining whether a Hospital is Subject to the Market 

Basket Update Adjustment for FY 2018 and Subsequent Fiscal Years

Section 1886(b)(3)(B)(ix)(IV) of the Act makes clear that the Secretary has 

discretion to specify as the EHR reporting period "any period (or periods)" that will apply 

"with respect to a fiscal year." In the Stage 2 final rule at 77 FR 54104 through 54105, 

we finalized the applicable EHR reporting period for purposes of determining whether an 

eligible hospital is subject to the payment adjustment. 

As with EPs, we finalized that the EHR reporting period for the payment 
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adjustment year for eligible hospitals will begin and end prior to the year of the payment 

adjustment. We finalized under § 495.4 of the regulations that for eligible hospitals, the 

EHR reporting period for a payment adjustment year is the full federal fiscal year that is 

2 years before the payment adjustment year. We established this policy beginning with 

the FY 2015 payment adjustment year and continuing in subsequent years. For example, 

the full federal fiscal year of 2015 would be the EHR reporting period for the FY 2017 

payment adjustment year. However, in this Stage 3 proposed rule, beginning in 2017, we 

propose to change the EHR reporting period for a payment adjustment year for eligible 

hospitals from a fiscal year basis to a calendar year basis. Specifically, we propose to 

revise the definition of "EHR reporting period for a payment adjustment year" under 

§ 495.4 such that the EHR reporting period for a payment adjustment year for an eligible 

hospital would be the full calendar year that is 2 years before the payment adjustment 

year. For example, the entire CY 2017 would be the EHR reporting period used to 

determine whether the payment adjustment would apply for an eligible hospital for 

FY 2019. This change would apply beginning with the CY 2017 EHR reporting period 

for purposes of the FY 2019 payment adjustment year, and continue to apply in 

subsequent years. We note that eligible hospitals would have ample time to adjust to the 

new calendar year reporting timeframe given that under our current policy, the EHR 

reporting period occurs prior to the payment adjustment year. We further believe that 

aligning all providers, including eligible hospitals, to a calendar year EHR reporting 

timeframe for purposes of the payment adjustment, would simplify reporting for all 

providers, especially for larger providers with diverse systems and groups. In addition, 
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placing all providers, including eligible hospitals, onto a calendar year timeframe would 

further simplify HHS system requirements for data capture and would move the EHR 

Incentive Program another step closer to alignment with various CMS quality reporting 

programs. We welcome comments on this proposal. 

Further, in the Stage 2 final rule, we finalized an exception to the general rule of a 

full federal fiscal year EHR reporting period for eligible hospitals that have never 

successfully attested to meaningful use. Stated generally, under this exception, for an 

eligible hospital that is demonstrating meaningful use for the first time, the EHR 

reporting period for a payment adjustment year is any continuous 90-day period. For a 

full description of this exception, including limitations on when the continuous 90-day 

period must occur in relation to the payment adjustment year and the deadlines for 

registration and attestation, we refer readers to the definition of "EHR reporting period 

for a payment adjustment year" under § 495.4 of the regulations and the discussion in the 

Stage 2 final rule (77 FR 54104 and54105).

However, in this Stage 3 proposed rule, we propose to eliminate this exception for 

eligible hospitals that are new meaningful EHR users beginning with the EHR reporting 

period in 2017, with a limited exception for Medicaid eligible hospitals demonstrating 

meaningful use for the first time. As explained previously, we propose that for eligible 

hospitals that have successfully demonstrated meaningful use in a prior year as well as 

those that have not, the EHR reporting period for a payment adjustment year would be 

the full calendar year that is 2 years before the payment adjustment year. For example, 

for all eligible hospitals, the full CY 2017 would be the EHR reporting period for the 
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FY 2019 payment adjustment year. This policy would continue to apply in subsequent 

years. 

Though, as discussed in sections II.A.1.a. and II.F.1. of this proposed rule, for 

Medicaid eligible hospitals demonstrating meaningful use for the first time, we are 

proposing to maintain a 90-day EHR reporting period for the first payment year based on 

meaningful use. We recognize that these eligible hospitals may be subject to payment 

adjustments under Medicare if they fail to demonstrate meaningful use, and thus we 

propose that the same 90-day EHR reporting period used for the Medicaid incentive 

payment would also apply for purposes of the Medicare payment adjustment for the 

payment adjustment year 2 years after the calendar year in which the provider 

demonstrates meaningful use. We note under our current policy, if an eligible hospital 

has never successfully demonstrated meaningful use, the EHR reporting period for a 

payment adjustment year is any continuous 90-day period that both begins in the federal 

fiscal year 1 year before the payment adjustment year and ends at least 3 months before 

the end of such prior year. We do not propose to maintain this policy, and thus for 

Medicaid eligible hospitals that are new meaningful EHR users, the 90-day EHR 

reporting period for a payment adjustment year must occur within the calendar year that 

is 2 years before the payment adjustment year. These proposals for Medicaid eligible 

hospitals would apply beginning with the EHR reporting period in CY 2017.

We provide the following example: 

Example A: If an eligible hospital has never successfully demonstrated 

meaningful use prior to CY 2017 and demonstrates under the Medicaid EHR Incentive 
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Program that it is a meaningful EHR user for the first time in CY 2017, the EHR 

reporting period for the Medicaid incentive payment would be any continuous 90-day 

period within CY 2017. The same 90-day period would also serve as the EHR reporting 

period for the FY 2019 payment adjustment year under Medicare. This 90-day period 

would not serve as the EHR reporting period for the FY 2018 payment adjustment year 

under Medicare even if the eligible hospital registers for and attests to meaningful use by

July 1, 2017. The eligible hospital would have to demonstrate meaningful use for an 

EHR reporting period of the full CY 2018 to earn an incentive payment under Medicaid 

for the 2018 payment year and avoid the payment adjustment under Medicare for the 

FY 2020 payment adjustment year.

Like our proposal to move eligible hospitals to a calendar year timeframe, we 

believe that removing the continuous 90-day EHR reporting period for most eligible 

hospitals would simplify reporting for providers, especially those hospitals with diverse 

groups and systems. In addition, eliminating the 90-day EHR reporting period would 

move the EHR Incentive Program one step closer to alignment within the program and 

with CMS quality reporting programs and would simplify HHS system requirements for 

data capture. Therefore, moving eligible hospitals to a calendar year EHR reporting 

period for the payment adjustment years, as well as requiring all providers (EPs and 

hospitals) to report based on the same full year calendar timeframe would accomplish 

these goals and be responsive to prior public comments asking us to simplify the EHR 

Incentive Program. 

We propose amendments to the definition of "EHR reporting period for a 
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payment adjustment year" under § 495.4 to reflect these proposals.

We note that hospitals that are eligible under both the Medicaid and Medicare 

incentive programs, and that are attesting for the Medicaid program, do not need to 

separately attest in the Medicare program in 2017 and subsequent years, because the 

statute does not allow for Medicare EHR incentive payments to eligible hospitals after 

FY 2016. If a hospital eligible under both programs is demonstrating meaningful use for 

the first time, and using a continuous 90-day EHR reporting period under the Medicaid 

program, it could attest for the Medicaid program only, and still avoid the Medicare 

payment adjustment that is 2 years after the calendar year in which the EHR reporting 

period occurs. However, if a hospital eligible under both programs chooses also to attest 

for the Medicare program, it would be required to complete an EHR reporting period of 1 

full calendar year to avoid the Medicare payment adjustment that is 2 years after that 

calendar year.

We welcome public comments on these proposals. 

7. Exception to the Application of the Market Basket Update Adjustment to Hospitals in 

FY 2019 and Subsequent Fiscal Years. 

As stated previously, section 1886(b)(3)(B)(ix)(II) of the Act, as amended by 

section 4102(b)(1) of the HITECH Act, provides that the Secretary, may, on a 

case-by-case basis, exempt a hospital from the application of the applicable percentage 

increase payment adjustment for a fiscal year if the Secretary determines that compliance 

with the requirements for being a meaningful EHR user will result in a significant 

hardship, such as an eligible hospital located in a rural area without sufficient internet 
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access. Section 1886(b)(3)(B)(ix)(III) also provides that the exception is subject to 

annual renewal, but in no case may a hospital be granted an exception for more than 

5 years. The Secretary's hardship exception authority is discretionary. 

As we explained in the Stage 2 final rule at 77 FR 54105 through 54106, we 

believe that certain circumstances may constitute a hardship that would warrant the 

Secretary's use of the exception authority. Therefore, in the Stage 2 final rule, we 

finalized various types of hardship exceptions for which eligible hospitals may apply, 

which included lack of insufficient internet access, extreme circumstances outside of a 

hospital's control, and the establishment of new hospitals. For further discussion of the 

hardship exceptions, we refer readers to the Stage 2 final rule at 77 FR 54105 through 

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

In this Stage 3 proposed rule, we propose no changes to the types of exceptions 

previously finalized for eligible hospitals, nor do we propose any new exceptions for 

eligible hospitals. Accordingly, for Stage 3, we propose to continue the hardship 

exceptions for 2017 and subsequent years as previously finalized. 

8. Statutory Basis for Payment Adjustments to CAHs

Section 4102(b)(2) of the HITECH Act amended section 1814(l) of the Act to 

include an adjustment to a CAH's Medicare reimbursement for inpatient services if the 

CAH is not a meaningful EHR user for an EHR reporting period. The adjustment will be 

made for cost reporting periods that begin in FY 2015, FY 2016, FY 2017, and each 

subsequent FY thereafter. Specifically, sections 1814(l)(4)(A) and (B) of the Act provide 

that, if a CAH does not demonstrate meaningful use of CEHRT for an applicable EHR 
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reporting period, then for a cost reporting period beginning in FY 2015, the CAH's 

reimbursement shall be reduced from 101 percent of its reasonable costs to 

100.66 percent of reasonable costs. For a cost reporting period beginning in FY 2016, its 

reimbursement would be reduced to 100.33 percent of its reasonable costs. For a cost 

reporting period beginning in FY 2017 and each subsequent fiscal year, its 

reimbursement would be reduced to 100 percent of reasonable costs. 

However, as provided for eligible hospitals, a CAH, may, on a case-by-case basis, 

be granted an exception from this adjustment if CMS or its Medicare contractor 

determines, on an annual basis, that a significant hardship exists, such as in the case of a 

CAH in a rural area without sufficient internet access. However, in no case may a CAH 

be granted this exception for more than 5 years. 

9. Reduction of Reasonable Cost Reimbursement in FY 2015 and Subsequent Years for 

CAHs that are Not Meaningful EHR Users

a. Applicable Reduction of Reasonable Cost Payment Reduction in FY 2015 and 

Subsequent Years for CAHs that are Not Meaningful EHR Users

In the Stage 1 final rule (75 FR 44564), we finalized the regulations regarding the 

CAH adjustment at § 495.106(e) and § 413.70(a)(6). 

b. EHR Reporting Period for Determining Whether a CAH is Subject to the Applicable 

Reduction of Reasonable Cost Payment in FY 2015 and Subsequent Years

In Stage 2, we amended the definition of the EHR reporting period that would 

apply for purposes of the payment adjustment for CAHs under § 495.4 (77 FR 54109 and 

54110). For CAHs, this is the full federal fiscal year that is the same as the payment 
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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 fiscal year as described in § 413.70(a)(6)(i). We further finalized that CAHs 

submit their attestations on meaningful use by November 30 of the following fiscal year. 

For example, if a CAH is attesting that it was a meaningful EHR user for FY 2015, the 

attestation must be submitted no later than November 30, 2015. Such an attestation or 

lack thereof, will then affect interim payments to the CAH made after December 1 of the 

applicable fiscal year. If the cost reporting period ends prior to December 1 of the 

applicable fiscal year, then any applicable payment adjustment will be made through the 

cost report settlement process. 

Under this Stage 3 proposed rule, we are proposing a change to the EHR reporting 

period that would apply for the payment adjustments for CAHs, beginning with the 

FY 2017 payment adjustment year. First, similar to what we proposed for eligible 

hospitals previously, we propose that the EHR reporting period for a payment adjustment 

year for CAHs would be a full calendar year, rather than a full federal fiscal year. We 

propose the EHR reporting period for a payment adjustment year would be the calendar 

year that overlaps the last 3 quarters of the federal fiscal year that is the payment 

adjustment year. For example, in order for a CAH to avoid application of the adjustment 
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to its reasonable costs incurred in a cost reporting period that begins in FY 2017, the 

CAH must demonstrate it is a meaningful EHR user for an EHR reporting period of the 

full CY 2017. This proposed change would mean that the EHR reporting period would 

no longer precisely align with the payment adjustment year. We propose amendments to 

the definition of "EHR reporting period for a payment adjustment year" under § 495.4 to 

reflect these proposals. 

In the Stage 2 final rule, we note the process for the implementation of a payment 

adjustment to CAH cost reports in relation to the EHR reporting period attestation 

deadline (77 FR 54109 and 54110). Under our Stage 3 proposal, we would need to move 

the CAH attestation deadline in order to accommodate the change to a calendar 

year-based EHR reporting period. Therefore, we propose to move the CAH attestation 

deadline to the last day in February following the end of the EHR reporting period as we 

currently allow for EPs. Any accounting shifts that occur as a result from the change to a 

calendar year-based EHR reporting period can be accommodated through the cost 

reporting and settlement process. The CAH must attest no later than 2 months 

(February 28 or February 29 if applicable) following the close of the EHR reporting 

period at the end of each calendar year to avoid the payment adjustment. Such an 

attestation or lack thereof, will then affect interim payments to the CAH made after 

March 1 of the applicable federal fiscal year. If the cost reporting period ends prior to 

March 1 of the applicable fiscal year, then any applicable payment adjustment will be 

made through the cost report settlement process. 

We are proposing this change to the EHR reporting period for the payment 
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adjustment year to further align most providers to a calendar year-based EHR reporting 

period. We believe that the change to calendar year reporting for CAHs is feasible given 

that the cost reporting and cost settlement processes is unique to CAHs under the 

Medicare EHR Incentive Program. Unlike eligible hospitals or EPs, who use a claims 

processing system to determine the payment adjustment under the Medicare EHR 

Program, CAHs are required to file an annual Medicare cost report that is typically for a 

consecutive 12-month period. The cost report reflects the inpatient statistical and 

financial data that forms the basis of the CAH's Medicare reimbursement. Interim 

Medicare payment may be made to the CAH during the cost reporting period based on 

the previous year's data. Cost reports are filed with the CAH's Medicare contractor after 

the close of the cost reporting period, and the data on the cost report are subject to the 

reconciliation and settlement process prior to a final Medicare payment being made. The 

proposed change to a calendar year EHR reporting period for CAHs would not 

significantly impact the ability to implement the payment adjustments in the cost report 

reconciliation process for either CAHs or CMS. It would only shift the potential date 

where the reconciliation of any payment adjustment in the cost reporting process may 

occur. These payments would still be subject to the reconciliation and settlement process 

prior to a final Medicare payment being made. 

For example, currently CAHs must file their attestations on meaningful use by 

November 30of the federal fiscal year following the close of the federal fiscal year in 

which the EHR reporting period occurs. Under our current system, if a CAH is attesting 

that it was a meaningful EHR user for FY 2015, the attestation must be submitted not 
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later than November 30, 2015. A payment adjustment applied if the CAH does not 

successfully attest would affect interim payment to the CAH made after December 1 of 

2015. If the cost reporting period ends prior to December 1, 2015, then any applicable 

payment adjustment will be made under the cost reporting settlement process. 

In an example of a similar scenario under the new proposal, a CAH that does not 

successfully demonstrate meaningful use based on a calendar year EHR reporting period 

in 2017 (January 1, 2017 through December 31, 2017) would be subject to a payment 

adjustment applied to its reasonable costs incurred in the cost reporting period beginning 

in FY 2017 (October 1, 2017 through September 30, 2018). To avoid the payment 

adjustment in this example, the CAH must attest no later than February 28, 2018 to 

demonstrate meaningful use for an EHR reporting period in 2017. If the CAH does not 

attest by February 28, 2018, a payment adjustment would then affect interim payments to 

the CAH made after March 1, 2018. If the cost reporting period ends prior to 

March 1, 2018, then any applicable payment adjustment would be made through the cost 

report settlement process. We note that this is reflective of a similar policy in the Stage 2 

final rule addressing the process for CAH payment adjustments with an attestation 

deadline of November 30 in a given year and direct readers to 77 FR 54110 for further 

information on this policy. 

Second, as noted previously, and outlined in the definition of "EHR reporting 

period for a payment adjustment year" under § 495.4, we established an exception for 

first-time CAH meaningful EHR users. Under our current policy, if a CAH is 

demonstrating it is a meaningful EHR user for the first time in the payment adjustment 
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year, the applicable EHR reporting period is any continuous 90-day period within the 

federal fiscal year that is the payment adjustment year. 

For this Stage 3 proposed rule, we propose to eliminate this exception for CAHs 

that are new meaningful EHR users beginning with the EHR reporting period in 2017, 

with a limited exception for CAHs demonstrating meaningful use for the first time under 

the Medicaid EHR Incentive Program. As discussed in II.A.1.a. and II.F.1. of this 

proposed rule, for CAHs that demonstrate meaningful use for the first time under 

Medicaid, we are proposing to maintain a 90-day EHR reporting period for the first 

payment year based on meaningful use. We recognize that these CAHs may be subject to 

payment adjustments under Medicare if they fail to demonstrate meaningful use, and thus 

we propose that the same 90-day EHR reporting period used for the Medicaid incentive 

payment would also apply for purposes of the Medicare payment adjustment. 

We propose amendments to the definition of "EHR reporting period for a 

payment adjustment year" under § 495.4 to reflect these proposals. Example A: If a 

CAH has never successfully demonstrated meaningful use prior to CY 2017 and 

demonstrates under the Medicaid EHR Incentive Program that it is a meaningful EHR 

user for the first time in CY 2017, the EHR reporting period for the Medicaid incentive 

payment would be any continuous 90-day period within CY 2017. The same 90-day 

period would also serve as the EHR reporting period for the FFY 2017 payment 

adjustment year under Medicare. 

Like our proposal to move CAHs to a calendar year timeframe, we believe that 

removing the continuous 90-day EHR reporting period for most CAHs would simplify 
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reporting for providers, especially those CAHs with diverse groups and systems. In 

addition, eliminating the 90-day EHR reporting period would move the EHR Incentive 

Program one step closer to alignment within the program and with CMS quality reporting 

programs, and would simplify HHS system requirements for data capture. Therefore, 

moving CAHs to a calendar year EHR reporting period for the payment adjustment year, 

as well as requiring most providers (EPs, CAHs, and eligible hospitals) to report based on 

the same full year calendar timeframe would accomplish these goals and be responsive to 

prior public comments asking us to simplify the EHR Incentive Program. 

We welcome public comments on these proposals. 

10. Administrative Review Process of Certain Electronic Health Record Incentive 

Program Determinations

In the Stage 2 final rule (77 FR 54112 through 54113), we discussed an 

administrative appeals process for both Stages 1 and 2 of meaningful use. We believe 

this appeals process is primarily procedural and does not need to be specified in 

regulation. We have developed guidance on the appeals process, which is available on 

our website at www.cms.gov/EHRIncentivePrograms. We propose no changes in this 

proposed rule and intend to continue to specify the appeals process in guidance available 

on our website.
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E. Medicare Advantage Organization Incentive Payments

We are not proposing any changes to the existing policies and regulations for 

Medicare Advantage (MA) organizations. Our existing policies and regulations include 

provisions concerning the EHR incentive payments to qualifying MA organizations and 

the payment adjustments for 2015 and subsequent MA payment adjustment years. (For 

more information on MA organization incentive payments, we refer readers to the final 

rules for Stages 1 and 2 (75 FR 44468 through 44482 and 77 FR 54113 through 54119).) 
CMS-3310-P 205

F. The Medicaid EHR Incentive Program

The proposals discussed in sections II.F.1. through II.F.3. of this proposed rule 

would be applicable upon the effective date of the final rule, not when Stage 3 of 

meaningful use of certified EHR technology begins, unless otherwise indicated. 

1. EHR Reporting Period for First Year of Meaningful Use

We are proposing amendments to the definitions of "EHR reporting period" and 

"EHR reporting period for a payment adjustment year" in § 495.4 to shift the EHR 

reporting periods for eligible hospitals and CAHs to periods that are based on the 

calendar year, not the federal fiscal year, and to establish a full calendar year as the EHR 

reporting period or EHR reporting period for a payment adjustment year for almost all 

providers beginning in 2017. However, we are also proposing a limited exception under 

which Medicaid EPs and eligible hospitals demonstrating meaningful use for the first 

time could use any continuous 90-day EHR reporting period within the calendar year. 

This EHR reporting period for Medicaid providers demonstrating meaningful use for the 

first time would apply both for purposes of receiving an incentive payment in the 

Medicaid program and for purposes of avoiding the payment adjustment under the 

Medicare program for the payment adjustment year that is two years after the calendar 

year in which the provider first demonstrates meaningful use for an EHR reporting 

period. Under this proposal, Medicaid EPs and eligible hospitals would have an EHR 

reporting period of any continuous 90-day period in the calendar year that is the payment 

year, for their first payment year based on meaningful use, beginning in 2017. We note 

that hospitals that are eligible under both the Medicaid and Medicare incentive programs, 
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and that are attesting for the Medicaid program, do not need to separately attest in the 

Medicare program in 2017 and subsequent years, because the statute does not allow for 

Medicare EHR incentive payments to eligible hospitals after FY 2016. If a hospital 

eligible under both programs is demonstrating meaningful use for the first time, and using 

a continuous 90-day EHR reporting period under the Medicaid program, it could attest 

for the Medicaid program only, and still avoid the Medicare payment adjustment that is 

2 years after the calendar year in which the EHR reporting period occurs. However, if a 

hospital eligible under both programs chooses also to attest for the Medicare program, it 

would be required to complete an EHR reporting period of 1 full calendar year to avoid 

the Medicare payment adjustment that is 2 years after that calendar year. We note that, 

consistent with the other proposed amendments to § 495.4 discussed previously, this 

proposal would change the EHR reporting period for eligible hospitals from one that is 

based on the federal fiscal year to one that is based on the calendar year, beginning in 

2017. For further discussion of the relationship between the 90-day EHR reporting 

period under the Medicaid EHR Incentive Program and the payment adjustments under 

Medicare, we refer readers to section II.D. of this proposed rule. 

This policy would allow Medicaid providers flexibility in their first year of 

demonstrating meaningful use. It also would reduce the burden on states to implement 

significant policy and system changes in preparation for Stage 3, as the 90-day period for 

the first year of meaningful use is consistent with our previous policies and meaningful 

use timelines. 

2. Reporting Requirements
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a. State Reporting on Program Activities

As discussed in section II.A.1.c.(1).(b).(iii). of this proposed rule, we are adding a 

new provision at § 495.316(d)(2)(iii) to provide states with flexibility regarding the 

Stage 3 public health and clinical data registry reporting objective. 

We also propose to amend § 495.316(c), as well as add a new paragraph 

§ 495.316(f), to formalize the process of how states report to us annually on the providers 

that have attested to adopt, implement, or upgrade (AIU), or that have attested to

meaningful use. Under this proposal, states would follow a structured submission 

process, in the manner prescribed by CMS, which would include a new annual reporting 

deadline. We propose to require states to submit annual reports to CMS within 45 days 

of the end of the second quarter of each federal fiscal year.

We propose to regularize the timing of the annual reporting process described in 

§ 495.316 to ensure more timely annual reports and allow for clearer communication to 

states on when the reports should be submitted to CMS. In addition, CMS and states 

would be able to more effectively track the progress of states' incentive program 

implementation and oversight as well as provider progress in achieving meaningful use. 

Predictable deadlines for annual reporting would permit CMS and the states to more 

quickly compare and assess overall program impact each year. 

We are also considering changes to the data that the annual reporting 

requirements outlined in § 495.316(d) require states to include in their annual reports. 

Specifically, we are considering whether to remove the requirement that states report 

information about practice location for providers that qualify for incentive payments on 
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the basis of having adopted, implemented, or upgraded certified EHR technology or on 

the basis of demonstrating they are meaningful users of certified EHR technology. While 

we believe that this data is useful to both CMS and the states for program implementation 

purposes, we believe the benefits of including it in state reports might be outweighed by 

the burdens to states of reporting it. Therefore, we are seeking more information on state 

burdens and costs associated with complying with this requirement. We solicit 

comments both on the burdens associated with the requirement to report practice location 

information for providers that receive incentive payments through the Medicaid EHR 

Incentive Program, and on the benefits of including this information in state reports.

We propose to amend § 495.352 to formalize the process of how states submit 

quarterly progress reports on implementation and oversight activities and to specify the 

elements that should be included in the quarterly reports. Under this proposal, states 

would follow a structured submission process, in the manner prescribed by CMS. We 

propose that states would report on the following activities: state system implementation 

dates; provider outreach; auditing; state-specific SMHP tasks; state staffing levels and 

changes; the number and type of providers that qualified for an incentive payment on the 

basis of demonstrating that they are meaningful EHR users of certified EHR technology 

and the amounts of incentive payments; and the number and type of providers that

qualified for an incentive payment on the basis of having adopted, implemented, or 

upgraded certified EHR technology and the amounts of incentive payments. 

We propose these changes to the quarterly reporting process described in 

§ 495.352 so that CMS and states can better track state implementation and oversight 
CMS-3310-P 209

activity progress in a way that would permit CMS and the states to compare overall 

programmatic and provider progress. We also expect that streamlined and enhanced 

quarterly progress reporting would lead to an improvement in overall data quality that 

would help inform future meaningful use activity across states. 

We would like to include a deadline for states' quarterly reporting under the 

proposed amendments to § 495.352, and are considering requiring states to submit 

quarterly progress reports to CMS within 30 days after the end of each federal fiscal year 

quarter. We believe that a set deadline would improve timeliness and communication, 

but we do not want to set a deadline that is overly burdensome for a report that must be 

submitted quarterly. We seek public comment on the deadline we are considering. 

b. State Reporting on Meaningful EHR Users

Starting in FY 2015 for eligible hospitals and CY 2015 for EPs, providers that fail 

to demonstrate meaningful use for an applicable EHR reporting period will be subject to 

downward payment adjustments under Medicare. As discussed in the Stage 2 final rule 

(77 FR 54094), EPs who are meaningful EHR users under the Medicaid EHR Incentive 

Program for an applicable EHR reporting period will be considered meaningful EHR 

users for that period for purposes of avoiding the Medicare payment adjustments. 

Currently, hospitals eligible for both Medicaid and Medicare incentive payments attest in 

both the Medicare and Medicaid systems to earn an incentive payment in both programs. 

The statute does not authorize Medicare EHR incentive payments to eligible hospitals 

after FY 2016. To avoid duplicative reporting, hospitals eligible under both programs

will not be required to attest in both programs beginning in 2017. Therefore, we must 
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have accurate and timely data from states regarding both EPs and eligible hospitals that 

have successfully demonstrated meaningful use for each payment year to ensure that 

meaningful EHR users in the Medicaid EHR Incentive Program are appropriately 

exempted from the Medicare payment adjustment for the applicable payment adjustment 

year. This additional reporting is necessary because the electronic data currently 

contained in the National Level Repository are insufficient to determine which Medicaid 

providers should be exempted from the Medicare payment adjustments in an accurate and 

timely manner. Accordingly, we propose to add new paragraphs (g) and (h) to § 495.316 

to require that states submit reports on a quarterly basis that identify certain providers that

attested to meaningful use through the Medicaid EHR Incentive Program for each 

payment year. Under this proposal, states would submit quarterly reports for Medicaid 

EPs and eligible hospitals that successfully attest to meaningful use for each payment 

year. 

We propose that states would report quarterly, in the manner prescribed by CMS, 

information on each provider that successfully attests to meaningful use, regardless of 

whether the provider has been paid yet. The report would be required to specify the 

Medicaid state and payment year. For each EP or eligible hospital listed in the report, the 

state would also specify the Payment Year Number, the NPI for EPs and the CCN for 

eligible hospitals, the Attestation Submission Date, the State Qualification (as either 

meaningful use or blank), and the State Qualification Date (the beginning date of the 

reporting period in which successful meaningful use attestation was achieved by the EP 

or eligible hospital). The EP or eligible hospital's "payment year number" refers to the 
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number of years that the provider has been paid in the EHR Incentive Program; so, for 

example, this would be "2" for the 2014 payment year if the provider received payments 

for 2013 and 2014. States would have this data, even for providers that have previously 

received an incentive payment through the Medicare EHR Incentive Program. If the state 

is reporting a disqualification, then the state would leave the State Qualification field 

blank. If applicable, in the cases of EPs or eligible hospitals previously identified as 

meaningful EHR users, the state would be required to specify the State Disqualification 

and State Disqualification Date (that is, the beginning date of the EHR reporting period 

during which an EP or eligible hospital was found not to meet the definition of a 

meaningful EHR user). 

Under this proposal, states would submit this information beginning with payment 

year 2013 data. The reports would cover back to the 2013 payment year because that 

would be the EHR reporting period for the 2015 Medicare payment adjustment year 

under § 495.4. Providers that successfully attested to meaningful use for 2013 would be 

exempt from the Medicare payment adjustment in 2015.

Under this proposal, states would not be required to include information about 

certain providers in their reports. We recognize that several provider types that are 

eligible for the Medicaid EHR Incentive Program are not subject to the Medicare 

payment adjustments. Accordingly, states would not be required to report on those EPs 

who are eligible for the Medicaid EHR Incentive Program on the basis of being a nurse 

practitioner, certified nurse-midwife, or physician assistant.

3. Clinical Quality Measurement for the Medicaid Program
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States are, and will continue in Stage 3 to be, responsible for determining whether 

and how electronic reporting of CQMs would occur, or whether they wish to allow 

reporting through attestation. This is consistent with our policy in the Stage 2 final rule 

(77 FR 54075). If a state does require electronic reporting, the state is responsible for 

sharing the details on the process with its provider community. We anticipate that 

whatever means states have deployed for capturing Stages 1 and 2 clinical quality 

measures electronically would be similar for reporting in 2017 and subsequent years.

However, we note that subject to our prior approval, this is within the states' purview. 

States that wish to establish the method and requirements for electronically reporting 

would continue to be required to do so through the SMHP submission, subject to our 

prior approval.

To further our goals of alignment and avoiding duplicative reporting across 

quality reporting programs, we would recommend that states include a narrative in their 

SMHP for CY 2017 describing how their proposed meaningful use CQM data submission 

strategy aligns with their State Medicaid Quality Strategy and report which certified EHR 

technology requirements they mandate for eCQM reporting. 

For more information on requirements around the State Medicaid Quality 

Strategy, see http://medicaid.gov/Federal-Policy-Guidance/Downloads/SHO-13-007.pdf. 
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III. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995, we are required to provide 60-day 

notice in the Federal Register and solicit public comment before a collection of 

information requirement is submitted to the Office of Management and Budget (OMB) 

for review and approval. In order to evaluate fairly whether an information collection 

should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 

1995 requires that we solicit comment on the following issues:

● The need for the information collection and its usefulness in carrying out the 

proper functions of our agency.

● The accuracy of our estimate of the information collection burden.

● The quality, utility, and clarity of the information to be collected. 

● Recommendations to minimize the information collection burden on the 

affected public, including automated collection techniques.

The following is a discussion of the requirements contained in this proposed 

regulation that we believe are subject to PRA and collection of information requirements 

(ICRs). The projected numbers of EPs, eligible hospitals, and CAHs, MA organizations, 

MA EPs and MA-affiliated hospitals are based on the numbers used in the impact 

analysis assumptions as well as estimated federal costs and savings in the section V.C. of 

this proposed rule. The actual burden would remain constant for all of Stage 3 as EPs, 

eligible hospitals, and CAHs would only need to attest that they have successfully 

demonstrated meaningful use in 2017 and annually thereafter. The only variable from 
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year-to-year in Stage 3 would be the number of respondents, as noted in the impact 

analysis assumptions. For the purposes of this analysis, we are focusing only on 2017, 

the first year in which a provider may participate in Stage 3 of the Medicare EHR 

Incentive Program. We do not believe the burden for EPs, eligible hospitals, and CAHs 

participating in Stages 1 and 2 prior to 2017 would be different from the Agency 

Information Collection Activities (75 FR 65354) based on this proposed rule. Beginning 

in 2012, Medicare EPs, eligible hospitals, and CAHs have the option to electronically 

report their clinical quality measures through the respective electronic reporting pilots. 

For eligible hospitals and CAHs, the burden is discussed in the CY 2012 Hospital 

Outpatient Prospective Payment System final rule with comment period (76 FR 73450 

through 73451). 

As discussed in section I.A.1.a. of this proposed rule, Stage 3 is intended to build 

on Stages 1 and 2 with a focus on advanced use of certified EHR technology to promote 

improved patient outcomes while assuring that the framework is flexible and does not 

hinder innovation. In this proposed rule, the definition of meaningful use with associated 

reporting requirements would replace all prior definitions and requirements beginning in 

2018. At that point, all eligible providers would be required to report only Stage 3

requirements on an annual basis. For 2017, providers may simply repeat their current 

status at Stage 1 or Stage 2, or move on to Stage 3. The same reporting time would apply 

to all providers. Consequently, the proposed ICRs reflect the provider burden associated 

with complying with and reporting of Stage 3 requirements beginning in 2017 and each 

subsequent year. 
CMS-3310-P 215

We are soliciting public comment on each of these issues for the following 

sections of this document that contain information collection requirements (ICRs). 

A. ICR Regarding Demonstration of Meaningful Use Criteria (§ 495.6, § 495.7 and 

§ 495.8)

In § 495.7 we propose that to successfully demonstrate meaningful use of 

certified EHR technology for Stage 3, an EP, eligible hospital, or CAH (collectively 

referred to as "provider" in this section) must attest, through a secure mechanism in a 

specified manner, to the following during the EHR reporting period-- 

 The provider used certified EHR technology and specified the technology was 

used; and 

 The provider satisfied each of the applicable objectives and associated 

measures in § 495.7. 

In § 495.8, we stipulate that providers must also successfully report the clinical quality 

measures selected by CMS to CMS or the states, as applicable. We estimate that the 

certified EHR technology adopted by the provider captures many of the objectives and 

associated measures and generate automated numerator and denominator information 

where required, or generate automated summary reports. We also expect that the 

provider would enable the functionality required to complete the objectives and 

associated measures that require the provider to attest that they have done so. 

We propose that there would be 5 objectives and 10 measures that would require 

an EP to enter numerators and denominators during attestation. Eligible hospitals and 

CAHs would have to attest they have met 5 objectives and 10 measures that would 
CMS-3310-P 216

require numerators and denominators. For objectives and associated measures requiring 

a numerator and denominator in this proposed rule, we limit our estimates to actions 

taken in the presence of certified EHR technology. We do not anticipate a provider 

would maintain two recordkeeping systems when certified EHR technology is present. 

Therefore, we assume that all patient records that would be counted in the denominator 

would be kept using certified EHR technology. We expect it would take an individual 

provider or designee approximately 10 minutes to attest to each meaningful use objective 

and associated measure that requires a numerator and denominator to be generated. The 

security risk assessment and its associated measure would not require a numerator and 

denominator and we would expect it would take an individual provider or designee 

approximately 6 hours to complete. The clinical decision support and active engagement 

with a public health agency measures would take an eligible professional, eligible 

hospital or critical access hospital 1 minute each to report each CDS intervention or 

registry. 

We propose that EPs would be required to report on a total of 8 objectives and 

16 associated measures. For the purpose of this proposed collection of information, we 

assumed that all eligible providers would comply with the requirements of meaningful 

use Stage 3. We propose that eligible hospitals and CAHs would be required to report on 

a total of 8 objectives and 17 associated measures. We estimated the total annual cost 

burden for all eligible hospitals and CAHs to attest to EHR technology, meaningful use 

objectives and associated measures, and electronically submit the clinical quality 

measures would be $2,135,204 (4,900 eligible hospitals and CAHs × 6 hours 52 minutes 
CMS-3310-P 217

× $63.46 (mean hourly rate for lawyers based on May 2013 BLS) data)). We estimate the 

total annual cost burden for all EPs to attest to EHR technology, meaningful use 

objectives and associated measures, and electronically submit the clinical quality 

measures would be $385,834,395 (609,100 EPs × 6 hours 52 minutes × $92.25 

(mean hourly rate for physicians based on May 2013 BLS) data). 

In this proposed rule, there are 5 objectives that would require an EP to enter 

numerators and denominators during attestation. Eligible hospitals and CAHs would 

have to attest that they have met five objectives that require numerators and 

denominators. For objectives and associated measures requiring a numerator and 

denominator, we limit our estimates to actions taken in the presence of certified EHR 

technology. We do not anticipate a provider would maintain two recordkeeping systems 

when certified EHR technology is present. Therefore, we assume that all patient records 

that would be counted in the denominator would be kept using certified EHR technology. 

We expect it would take an individual provider or designee approximately 10 minutes to 

attest to each meaningful use objective and associated measure that requires a numerator 

and denominator to be generated, as well as each CQM for providers attesting in their 

first year of the program. 

Additionally, providers would be required to report they have completed 

objectives and associated measures that require a "yes" or "no" response during 

attestation. For EPs, there are three objectives that would require a "yes" or "no"

response during attestation. As discussed previously, the associated measures are that 

EPs are required to conduct a security risk analysis, report to three registries to fulfil the 
CMS-3310-P 218

public health objective, and must implement at least five clinical decision support 

interventions. For eligible hospitals and CAHs, there are three objectives that would

require a "yes" or "no" response during attestation. The associated measures for eligible 

hospitals and CAHs require the provider to conduct a security risk analysis, report to 

four registries to fulfill the public health objective and must implement at least 

five clinical decision support interventions. We estimate each of these measures would 

take 1 minute to report.

Providers would also be required to attest that they are protecting electronic health 

information. We estimate completion of the analysis required to meet successfully the 

associated measure for this objective would take approximately 6 hours, which is 

identical to our estimate for the Stage 1 and Stage 2 requirements. This burden estimate 

assumes that covered entities are already conducting and reviewing these risk analyses 

under current HIPAA regulations. Therefore, we have not accounted for the additional 

burden associated with the conduct or review of such analyses. 

Table 6 lists those objectives and associated measures for EPs and eligible 

hospitals and CAHs. We estimate the objectives and associated measures would take an 

EP 6 hours 52 minutes to complete, and would take an eligible hospital or CAH 6 hours 

52 minutes to complete. 

In this proposed rule EPs, eligible hospitals, and CAHs have virtually identical 

burdens. Eligible hospitals and CAHs are required to report to one additional registry 

than EPs are required to report. Consequently, we have not prepared lowest and highest 
CMS-3310-P 219

burdens. Rather, we have computed a burden for EPs and a burden for eligible hospitals 

and CAHs. 
CMS-3310-P 220

TABLE 6: BURDEN ESTIMATES

Objectives - Eligible 

Professionals

Objectives - Eligible 

Hospitals/CAHs Measures

Burden Estimate 

per Respondent 

(EPs)

Burden 

Estimate per 

Respondent 

(Hospitals)

Protect electronic protected 

health information (ePHI) 

created or maintained by the 

CEHRT through the 

implementation of appropriate 

technical, administrative and 

physical safeguards.

Protect electronic protected health 

information (ePHI) created or 

maintained by the CEHRT 

through the implementation of 

appropriate technical, 

administrative and physical 

safeguards

Conduct or review a security risk 

analysis in accordance with the 

requirements under 

45 CFR 164.308(a)(1), including 

addressing the security (to include 

encryption) of data stored in CEHRT in 

accordance with requirements under 

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

45 CFR 164.306(d)(3), implement 

security updates as necessary, and 

correct identified security deficiencies 

as part of the provider's risk 

management process.

6 hours 6 hours

Generate and transmit 

permissible prescriptions 

electronically (eRx.)

Generate and transmit permissible 

discharge prescriptions 

electronically (eRx).

1. EP Measure: More than 80% of all 

permissible prescriptions written by the 

EP are queried for a drug formulary 

and transmitted electronically using 

CEHRT.

2. Eligible Hospital Measure: More 

than 25% of hospital discharge 

medication orders for permissible 

prescriptions (for new and changed 

prescriptions) are queried for a drug 

formulary and transmitted 

electronically using CEHRT.

10 minutes 10 minutes

Implement clinical decision 

support (CDS) interventions 

focused on improving 

performance on high-priority 

health conditions.

Implement clinical decision 

support (CDS) interventions 

focused on improving 

performance on high-priority 

health conditions.

Measure 1. The EP, eligible hospital 

and CAH must implement five clinical 

decision support interventions related

to four or more CQMs at a relevant 

point in patient care for the entire EHR 

1 minute 1 minute
CMS-3310-P 221

Objectives - Eligible 

Professionals

Objectives - Eligible 

Hospitals/CAHs Measures

Burden Estimate 

per Respondent 

(EPs)

Burden 

Estimate per 

Respondent 

(Hospitals)

reporting period. Absent four CQMs 

related to an EP, eligible hospital, or 

CAH's scope of practice or patient 

population, the clinical decision 

support interventions must be related to 

high-priority health conditions.

Measure 2: The EP, eligible hospital, 

or CAH has enabled and implemented 

the functionality for drug-drug and 

drug-allergy interaction checks for the 

entire EHR reporting period.

Use computerized provider order 

entry (CPOE) for medication, 

laboratory, and diagnostic 

imaging orders directly entered 

by any licensed healthcare 

professional, credentialed 

medical assistant, or a medical 

staff member credentialed to and 

performing the equivalent duties 

of a credentialed medical 

assistant; who can enter orders 

into the medical record per state, 

local, and professional 

guidelines. 

Use computerized provider order 

entry (CPOE) for medication, 

laboratory, and diagnostic 

imaging orders directly entered 

by any licensed healthcare 

professional, credentialed medical 

assistant, or a medical staff 

member credentialed to and 

performing the equivalent duties 

of a credentialed medical 

assistant; who can enter orders 

into the medical record per state, 

local, and professional guidelines. 

Measure 1. More than 80 percent of 

medication orders created by the EP or 

authorized providers of the eligible 

hospital's or CAH's inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period are 

recorded using computerized provider 

order entry.

Measure 2: More than 60 percent of 

laboratory orders created by the EP or 

authorized providers of the eligible 

hospital's or CAH's inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period are 

recorded using computerized provider 

order entry.

Measure 3: More than 60 percent of 

diagnostic imaging orders created by 

the EP or authorized providers of the 

eligible hospital's or CAH's inpatient or 

emergency department (POS 21 or 23) 

10 minutes 10 minutes
CMS-3310-P 222

Objectives - Eligible 

Professionals

Objectives - Eligible 

Hospitals/CAHs Measures

Burden Estimate 

per Respondent 

(EPs)

Burden 

Estimate per 

Respondent 

(Hospitals)

during the EHR reporting period are 

recorded using computerized provider 

order entry.

The EP provides access for 

patients to view online, 

download, and transmit their 

health information, or retrieve 

their health information through 

an API, within 24 hours of its 

availability.

The eligible hospital or CAH 

provides access for patients to 

view online, download, and 

transmit their health information, 

or retrieve their health 

information through an API, 

within 24 hours of its availability.

Measure 1: For more than 80 percent 

of all unique patients seen by the EP or 

discharged from the eligible hospital or 

CAH inpatient or emergency 

department (POS 21 or 23):

(1) The patient (or the patient 

authorized representative) is 

provided access to view online, 

download, and transmit his or her

health information within 24 hours 

of its availability to the provider; 

or 

1) (2) The patient (or the patient 

authorized representative) is 

provided access to an ONCcertified API that can be used 

by third-party applications or 

devices to provide patients (or 

patient authorized 

representatives) access to their 

health information, within 

24 hours of its availability to 

the provider.

Measure 2: The EP, eligible hospital or 

CAH must use clinically relevant 

information from CEHRT to identify 

patient-specific educational resources 

and provide electronic access to those 

materials to more than 35 percent of 

unique patients seen by the EP or 

discharged from the eligible hospital or 

CAH inpatient or emergency 

10 minutes 10 minutes
CMS-3310-P 223

Objectives - Eligible 

Professionals

Objectives - Eligible 

Hospitals/CAHs Measures

Burden Estimate 

per Respondent 

(EPs)

Burden 

Estimate per 

Respondent 

(Hospitals)

department (POS 21 or 23) during the 

EHR reporting period. 

Use communications functions of 

certified EHR technology to 

engage with patients or their 

authorized representatives about 

the patient's care. 

Use communications functions of 

certified EHR technology to 

engage with patients or their 

authorized representatives about 

the patient's care. 

Measure 1: During the EHR reporting 

period, more than 25 percent of all 

unique patients seen by the EP or 

discharged from the eligible hospital or 

CAH inpatient or emergency 

department (POS 21 or 23) actively 

engage with the electronic health 

record made accessible by the provider. 

An EP may meet the measure by either-

- 

(1) More than 25 percent of 

all unique patients (or patientauthorized representatives) seen by the 

EP or discharged from the eligible 

hospital or CAH during the EHR 

reporting period view, download or 

transmit to a third party their health 

information; or

(2) More than 25 percent of 

all unique patients (or 

patient-authorized representatives) seen 

by the EP or discharged from the 

eligible hospital or CAH inpatient or 

emergency department (POS 21 or 23) 

during the EHR reporting period access 

their health information through the use 

of an ONC-certified API that can be 

used by third-party applications or 

devices. 

Measure 2: During the EHR reporting 

period, for more than 35 percent of all 

unique patients seen by the EP or 

discharged from the eligible hospital or 

10 minutes 10 minutes
CMS-3310-P 224

Objectives - Eligible 

Professionals

Objectives - Eligible 

Hospitals/CAHs Measures

Burden Estimate 

per Respondent 

(EPs)

Burden 

Estimate per 

Respondent 

(Hospitals)

CAH during the EHR reporting period, 

a secure message was sent using the 

electronic messaging function of 

CEHRT to the patient (or their 

authorized representatives), or in 

response to a secure message sent by 

the patient.

Measure 3: Patient-generated health 

data or data from a non-clinical setting 

is incorporated into the certified EHR 

technology for more than 15 percent of 

all unique patients seen by the EP or 

discharged by the eligible hospital or 

CAH during the EHR reporting period.

The EP provides a summary of 

care record when transitioning or 

referring their patient to another 

setting of care, retrieves a 

summary of care record upon the 

first patient encounter with a new 

patient, and incorporates 

summary of care information 

from other providers into their 

EHR using the functions of 

certified EHR technology. 

The eligible hospital or CAH 

provides a summary of care 

record when transitioning or 

referring their patient to another 

setting of care, retrieves a 

summary of care record upon the 

first patient encounter with a new 

patient, and incorporates 

summary of care information 

from other providers into their 

EHR using the functions of 

certified EHR technology. 

Measure 1: For more than 50 percent 

of transitions of care and referrals, the 

EP, eligible hospital or CAH that 

transitions or refers their patient to 

another setting of care or provider of 

care-- (1) creates a summary of care 

record using CEHRT; and (2) 

electronically exchanges the summary 

of care record. 

Measure 2: For more than 40 percent 

of transitions or referrals received and 

patient encounters in which the 

provider has never before encountered 

the patient, the EP, eligible hospital or 

CAH incorporates into the patient's 

record in their EHR an electronic 

summary of care document from a 

source other than the provider's EHR 

system. 

Measure 3: For more than 80 percent of 

10 minutes 10 minutes
CMS-3310-P 225

Objectives - Eligible 

Professionals

Objectives - Eligible 

Hospitals/CAHs Measures

Burden Estimate 

per Respondent 

(EPs)

Burden 

Estimate per 

Respondent 

(Hospitals)

transitions or referrals received and 

patient encounters in which the 

provider has never before encountered 

the patient, the EP, eligible hospital, or 

CAH performs clinical information 

reconciliation. The provider would

choose at least two of the following 

three clinical information sets on which 

to perform reconciliations:

Medication. Review of the patient's 

medication, including the name, 

dosage, frequency, and route of each 

medication.

Medication allergy. Review of the 

patient's known allergic medications.

Current Problem list. Review of the 

patient's current and active diagnoses.

The EP is in active engagement 

with a PHA or CDR to submit 

electronic public health data in a 

meaningful way using certified 

EHR technology, except where 

prohibited, and in accordance 

with applicable law and practice. 

The eligible hospital or CAH is in 

active engagement with a PHA or 

CDR to submit electronic public 

health data in a meaningful way 

using certified EHR technology, 

except where prohibited, and in 

accordance with applicable law 

and practice. 

Providers must report data on an 

ongoing basis to established public 

health registries.

Measure 1 – Immunization Registry 

Reporting: The EP, eligible hospital, or 

CAH is in active engagement with a 

public health agency to submit 

immunization data and receive 

immunization forecasts and histories 

from the public health immunization 

registry/immunization information 

system (IIS).

Measure 2 – Syndromic Surveillance 

Reporting: The EP, eligible hospital, or 

CAH is in active engagement with a 

public health agency to submit 

syndromic surveillance data from a 

1 minute 1 minute
CMS-3310-P 226

Objectives - Eligible 

Professionals

Objectives - Eligible 

Hospitals/CAHs Measures

Burden Estimate 

per Respondent 

(EPs)

Burden 

Estimate per 

Respondent 

(Hospitals)

non-urgent care ambulatory setting for 

EPs, or an emergency or urgent care 

department for eligible hospitals and 

CAHs (POS 23).

Measure 3 - Case Reporting: The EP, 

eligible hospital, or CAH is in active 

engagement with a public health 

agency to submit case reporting of 

reportable conditions.

Measure 4 - Public Health Registry 

Reporting: The EP, eligible hospital, or 

CAH is in active engagement with a 

public health agency to submit data to 

public health registries. 

Measure 5 – Clinical Data Registry 

Reporting: The EP, eligible hospital, or 

CAH is in active engagement to submit 

data to a clinical data registry. 

Measure 6 – Electronic Reportable 

Laboratory Result Reporting: The 

eligible hospital or CAH is in active 

engagement with a public health 

agency to submit electronic reportable 

laboratory results. 

EP Objective: report to 3 of the 

following registries:

Immunization

Syndromic Surveillance

Case Reporting

Public Health 

Clinical Data
CMS-3310-P 227

Objectives - Eligible 

Professionals

Objectives - Eligible 

Hospitals/CAHs Measures

Burden Estimate 

per Respondent 

(EPs)

Burden 

Estimate per 

Respondent 

(Hospitals)

EPs may choose to report to more than 

one public health registry to meet the 

number of measures required to meet 

the objective.

EPs may choose to report to more than 

one clinical data registry to meet the 

number of measures required to meet 

the objective.

EH/CAH Objective: report to 4 of the 

following registries:

Immunization

Syndromic Surveillance

Case Reporting

Public Health 

Clinical Data

Electronic Reportable Laboratory 

Results

Eligible hospitals and CAHs may 

choose to report to more than one 

public health registry to meet the 

number of measures required to meet 

the objective.

Eligible hospitals and CAHs may 

choose to report to more than one 

clinical data registry to meet the 

number of measures required to meet 

the objective.

Criteria Burden 6 hours 52 minutes 6 hours 52 minutes

Time to Attest and Report Clinical Quality Measures

Total - Criteria Burden 6 hours 52 minutes 6 hours 52 minutes
CMS-3310-P 228
CMS-3310-P 229

In this proposed rule, we estimate that it would take no longer than 6 hours and 

52 minutes for an EP to satisfy each of the applicable objectives and associated measures. The 

total burden hours for an EP to attest to the criteria previously specified would be 6 hours 

52 minutes. We estimate that there could be approximately 609,100 non-hospital-based 

Medicare and Medicaid EPs in 2017. 

We estimate the burden for the approximately 13,635 MA EPs in the MAO burden 

section. We estimate the total burden associated with these requirements for an EP would be 

6 hours 52 minutes. The total estimated annual cost burden for all EPs to attest to EHR 

technology and meaningful use objectives would be $385,834,395 (506,400 x 6 hours 52 minutes 

x $92.25 (mean hourly rate for physicians based on May 2013 BLS data)). 

Similarly, eligible hospitals and CAHs would attest that they have met the core 

meaningful use objectives and associated measures, and would electronically submit the clinical 

quality measures. We estimate that it would take no longer, than 6 hours and 52 minutes to attest 

that during the EHR reporting period, they used the certified EHR technology, specify the EHR 

technology used and satisfied each of the applicable objectives and associated measures. We 

estimate that there are about 4,900 eligible hospitals and CAHs (3,397 acute care hospitals, 1,395

CAHs, 97 children's hospitals, and 11 cancer hospitals) that may attest to the aforementioned 

criteria in FY 2017. We estimate the total burden associated with these requirements for an 

eligible hospital and CAH would be 6 hours 52 minutes. The total estimated annual cost burden 

for all eligible hospitals and CAHs to attest to EHR technology, meaningful use core set and 

menu set criteria, and electronically submit the clinical quality measures would be $2,135,204

(4,908 eligible hospitals and CAHs x $63.46 (6 hours 52minutes x $63.46 (mean hourly rate for 

lawyers based on May 2013 BLS) data)). 
CMS-3310-P 230

B. ICRs Regarding Qualifying MA Organizations (§ 495.210)

In this proposed rule, we estimate that the burden would be significantly less for 

qualifying MA organizations attesting to the meaningful use of their MA EPs in Stage 3, because 

qualifying MA EPs use the EHR technology in place at a given location or system, so if certified 

EHR technology is in place and the qualifying MA organization requires its qualifying MA EPs 

to use the technology, qualifying MA organizations would be able to determine at a faster rate 

than individual FFS EPs, that its qualifying MA EPs meaningfully used certified EHR 

technology. In other words, qualifying MA organizations can make the determination together if 

the certified EHR technology is required to be used at its facilities, whereas under FFS, each EP 

likely must make the determination on an individual basis. We estimate that, on average, it 

would take an individual 45 minutes to collect information necessary to determine if a given 

qualifying MA EP has met the meaningful use objectives and measures, and 15 minutes for an 

individual to make the attestation for each MA EP. Furthermore, the individuals performing the 

assessment and attesting would not likely be eligible professional, but non-clinical staff. We 

believe that the individual gathering the information could be equivalent to a GS 11, step 1 (2015

unadjusted for locality rate), with an hourly rate of approximately $25.00/hour, and the person 

attesting (and who may bind the qualifying MA organization based on the attestation) could be 

equivalent to a GS 15, step 1 (2015 unadjusted for locality rate), or approximately $50.00/hour. 

Therefore, for the estimated 13,635 potentially qualifying MA EPs, we believe it would cost the 

participating qualifying MA organizations approximately $426,050 annually to make the 

attestations ([10,226 hours x $25.00]+[3,408 hours x $50.00]). 
CMS-3310-P 231

C. ICR Regarding State Reporting Requirements (§ 495.316 and § 495.352)

We are proposing to revise 42 CFR 495 regarding state reporting requirements to CMS. 

With respect to the annual reporting requirements in § 495.316 and the quarterly reporting 

requirements in § 495.352, we do not believe that the proposed amendments to these reporting 

requirements would increase the burden on states beyond what was previously finalized under 

OMB control number 0938-1158 following the Stage 2 final rule. The deadlines we propose or 

are considering would be consistent with our past practice, and the changes we propose or 

consider to the data elements to be reported on would be either reduced or similar in burden. 

Similarly, we do not expect the proposed amendments regarding the 90-day EHR reporting 

period for first time meaningful users would impose a burden on states because those 

amendments would generally maintain the current policy.

However, we are proposing to revise § 495.316 to include a new quarterly reporting 

requirement. Under the proposed amendment, states would report quarterly to CMS regarding 

the EPs and Medicaid eligible hospitals that have successfully demonstrated meaningful use for 

each payment year. We need this information to ensure that those EPs who are meaningful EHR 

users in the Medicaid EHR Incentive Program are appropriately exempted from the Medicare 

payment adjustment. We cannot accurately exempt these providers using the current data 

received from states. We expect that it would take a state 20 hours each year to submit this 

report on a quarterly basis. We believe that the state employee reporting the information could 

be equivalent to a GS 12, step 1 (2015 unadjusted for locality rate), with an hourly rate of 

approximately $30.00/hour. This amount is then reduced by the 90 percent federal contribution 

for administrative services for Medicaid under the EHR Incentive Programs, this equates to 
CMS-3310-P 232

approximately $3.00/hour. Therefore, for all state Medicaid agencies to report four times per 

year at 20 hours per report the estimated cost is $13,460 (4560 hours x $3.00/hour).
CMS-3310-P 233

TABLE 7: ESTIMATED ANNUAL INFORMATION COLLECTION BURDEN

Reg Section

OMB 

Control No.

Number

of 

Respondents

Number 

of 

Responses

Burden 

per 

Response 

(hours)

Total 

Annual 

Burden 

(hours)

Hourly 

Labor Cost 

of 

Reporting 

($)

Total Cost 

($)

§495.x - Objectives/Measures (EPs) 0938--1158 609,100 609,100 6.86 4,178,426 92.25 385,834,395

§495.6 Objectives/Measures (hospitals/CAHs) 0938--1158 4,900 4,900 6.86 33,614 63.46 2,135,204

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

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

§495.316 – Quarterly Reporting 0938—1158 56 224 20 4480 3.00 13,440

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

Notes: 

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

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

column from Table 7.
CMS-3310-P 234

If you would like to comment on these information collection and recordkeeping requirements, 

please do either of the following: 

1. Submit your comments electronically as specified in the ADDRESSES section of this 

final rule; or 

2. Submit your comments to the Office of Information and Regulatory Affairs, Office of 

Management and Budget,

Attention: CMS Desk Officer, [CMS-3310-P]

Fax: (202) 395-6974; or 

Email: OIRA_submission@omb.eop.gov

IV. Response to Comments

Because of the large number of public comments we normally receive on Federal 

Register documents, we are not able to acknowledge or respond to them individually. We will 

consider all comments we receive by the date and time specified in the "DATES" section of this 

proposed rule, and when we proceed with a subsequent document, we will respond to the 

comments in the preamble to that document.
CMS-3310-P 235

V. Regulatory Impact Analysis

A. Statement of Need

This proposed rule would implement the provisions of the ARRA that provide incentive 

payments to EPs, eligible hospitals, and CAHs participating in Medicare and Medicaid programs 

that adopt and meaningfully use certified EHR technology. This proposed rule specifies 

applicable criteria for demonstrating Stage 3 of meaningful use. 

B. Overall Impact

We have examined the impacts of this rule as required by Executive Order 12866 on 

Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving 

Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) 

(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of 

the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 

13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of 

available regulatory alternatives and, if regulation is necessary, to select regulatory approaches 

that maximize net benefits (including potential economic, environmental, public health and 

safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be 

prepared for major rules with economically significant effects ($100 million or more in any 

1 year). This proposed rule is anticipated to have an annual effect on the economy of 

$100 million or more, making it an economically significant rule under the Executive Order and 

a major rule under the Congressional Review Act. Accordingly, we have prepared a Regulatory 

Impact Analysis (RIA) that presents the estimated costs and benefits of this proposed rule. 
CMS-3310-P 236

As noted in section I.A.2. of this proposed rule, this proposed rule is one of two 

coordinated rules related to the meaningful use of certified EHR technology. The other is ONC's

2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition 

Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program 

Modifications proposed elsewhere in this issue of the Federal Register. This analysis focuses 

on the impact associated with Stage 3 requirements for meaningful use, the changes in quality 

measures that would take effect beginning in 2017, and other changes being proposed for the 

Medicare and Medicaid EHR Incentive Programs. 

As we discussed in the Stage 2 final rule (77 FR 54163 through 54291), a number of 

factors would affect the adoption of EHR systems and demonstration of meaningful use. In this 

proposed rule, we continue to believe that a number of factors would affect the adoption of EHR 

systems and demonstration of meaningful use. Readers should understand that these forecasts 

are also subject to substantial uncertainty since demonstration of meaningful use will depend not 

only on the standards and requirements for 2017 and for eligible hospitals and EPs, but on future 

rulemakings issued by the HHS. 

We further stated in the 2012 Stage 2 final rule (77 FR 54135 through 54136), the statute

provides Medicare and Medicaid incentive payments for the meaningful use of certified EHR 

technology. Additionally, the Medicaid program also provides incentives for the adoption, 

implementation, and upgrade of certified EHR technology. Beginning in 2015, payment 

adjustments are incorporated into the Medicare EHR Incentive Program for providers unable to 

demonstrate meaningful use. The absolute and relative strength of these is unclear. For 

example, a provider with relatively small Medicare billings will be less disadvantaged by 

payment adjustments than one with relatively large Medicare billings. Another uncertainty 
CMS-3310-P 237

arises because there are likely to be "bandwagon" effects as the number of providers using EHRs 

rises, thereby inducing more participation in the incentives program, as well as greater adoption 

by entities (for example, clinical laboratories) that are not eligible for incentives or subject to 

payment adjustments, but do business with EHR adopters. It is impossible to predict exactly if 

and when such effects may take hold. 

An uncertainty arises because under current law, physicians are scheduled for a large 

payment reduction in April 2015 under the sustainable growth rate (SGR) formula, which 

determines Medicare physician payment updates. A large payment reduction could cause major 

changes in physician behavior, enrollee care, and other Medicare provider payments, but the 

specific nature of these changes is uncertain. Under current law, the remaining EHR incentives 

for Medicaid or the Medicaid payment adjustments will exert only a minor influence on 

physician behavior relative to this large physician payment reduction. However, the Congress 

has legislatively avoided a large physician payment reduction for each year since 2002. 

All of these factors taken together make it impossible in this proposed rule to predict with 

precision the timing or rates of adoption and meaningful use. However, new data is currently 

available regarding rates of adoption or costs of implementation since the publication of our 

Stage 1 and Stage 2 final rules. We have included the new data in our estimates, although even 

these forecasts are still fairly uncertain. 

Overall, in this proposed rule, we expect spending under the EHR incentive program for 

transfer payments to Medicare and Medicaid providers between 2017 and 2020 to be $3.7 billion 

(this estimate includes net payment adjustments for Medicare providers who do not achieve 

meaningful use in the amount of $0.8 billion). We have also estimated "per entity" costs for EPs, 

eligible hospitals, and CAHs for implementation/maintenance and reporting requirement costs, 
CMS-3310-P 238

not all costs. We believe many adopting entities may achieve dollar savings at least equal to 

their total costs, and that there may be additional benefits to society. We also believe that 

implementation costs are significant for each participating entity because providers who were 

like to qualify as meaningful users of EHRs were likely to purchase certified EHR technology. 

However, we believe that providers who have already purchased certified EHR technology and 

participated in Stage 1 or Stage 2 of meaningful use will experience significantly lower costs for 

participation in the program. We continue to believe that the short-term costs to demonstrate 

meaningful use of certified EHR technology may be outweighed by the long-term benefits, 

including practice efficiencies and improvements in medical outcomes. Although both cost and 

benefit estimates are highly uncertain, the RIA that we have prepared presents the estimated 

costs and benefits of this proposed rule. 

C. Anticipated Effects

The objective of the remainder of this proposed RIA is to summarize the costs and 

benefits of the HITECH Act incentive program for the Medicare FFS, Medicaid, and MA 

programs. We also provide assumptions and a narrative addressing the potential costs to the 

health care industry for implementation of this technology. 

1. Overall Effects

a. EHR Technology Development and Certification Costs

We note that the costs incurred by IT developers for EHR technology development and 

certification to the 2015 Edition certification criteria for health IT are also in part attributable to 

the requirements for the use of CEHRT established in this proposed rule for Stage 3 of the EHR 

Incentive Programs. Therefore, to the extent that providers' implementation and adoption costs 

are attributable to this proposed rule, health IT developers' preparation and development costs 
CMS-3310-P 239

would also be attributable as these categories of activities may be directly or indirectly 

incentivized by the requirements to demonstrate meaningful use. However, even if this Stage 3 

proposed rule were not finalized, other CMS programs (for example PQRS and IQR) do require 

or promote certification to ONC's criteria – or a professional organization or other such entity 

could require or promote certification to ONC's critieria.

13

 As noted previously, this analysis 

focuses on the impact associated with Stage 3 requirements for meaningful use for providers; 

while the development and certification costs are addressed in the the 2015 Edition proposed rule

published elsewhere in this issues of the Federal Register. 

b. Regulatory Flexibility Analysis and Small Entities

The Regulatory Flexibility Act (RFA) requires agencies to prepare an Initial Regulatory 

Flexibility Analysis to describe and analyze the impact of the proposed rule on small entities 

unless the Secretary can certify that the regulation will not have a significant impact on a 

substantial number of small entities. In the health care sector, Small Business Administration 

(SBA) size standards define a small entity as one with between $7 million and $34 million in 

annual revenues. For the purposes of the RFA, essentially all 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 would be economically significant. Accordingly, this RIA section, in conjunction with 

 

13 In this case, the provider implementation and adoption costs discussed in this CMS RIA would instead be 

attributable to ONC's rulemaking.
CMS-3310-P 240

the remainder of the preamble, constitutes the required Initial Regulatory Flexibility Analysis 

(IRFA). We believe that the adoption and meaningful use of EHRs will have an impact on 

virtually every EP and eligible hospital, as well as CAHs and some EPs and hospitals affiliated 

with MA organizations. While the program is voluntary, in the first 5 years it carries substantial 

positive incentives that make it attractive to virtually all eligible entities. Furthermore, entities 

that do not demonstrate meaningful use of EHR technology for an applicable reporting period 

will be subject to significant Medicare payment reductions beginning in 2015. These Medicare 

payment adjustments are expected to motivate EPs, eligible hospitals, and CAHs to adopt and 

meaningfully use certified EHR technology. 

For some EPs, CAHs, and eligible hospitals the EHR technology currently implemented

could be upgraded to meet the criteria for certified EHR technology as defined for this program. 

These costs may be minimal, involving no more than a software upgrade. "Home-grown" EHR 

systems that might exist may also require an upgrade to meet the certification requirements. We 

believe many currently used non-certified EHR systems will require significant changes to 

achieve certification and that EPs, CAHs, and eligible hospitals will have to make process 

changes to achieve meaningful use. 

Data available suggests that more providers have adopted EHR technology since the 

publication of the Stage 1 final rule. An ONC data brief (No. 16, May 2014) noted that hospital 

adoption of EHR systems has increased 5 fold since 2008. Nine in ten acute care hospitals 

possessed CEHRT in 2013, increasing 29 percent since 2011. In January 2014, a Centers for 

Disease Control and Prevention (CDC) data brief entitled, "Use and Characteristics of Electronic 

Health Record Systems Among Office-based 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 
CMS-3310-P 241

2001. The majority of EPs have already purchased certified EHR technology, implemented this 

new technology, and trained their staff on its use. The costs for implementation and complying 

with the criteria of meaningful use could lead to higher operational expenses. However, we 

believe that the combination of payment incentives and long-term overall gains in efficiency may 

compensate for some of the initial expenditures. 

(1) Small Entities

We estimate that EPs would spend approximately $54,000 to purchase and implement a 

certified EHR and $10,000 annually for ongoing maintenance according to the Congressional 

Budget Office (CBO) (75 FR 44546). 

In the paper, Evidence on the Costs and Benefits of Health Information Technology, 

May 2008, in attempting to estimate the total cost of implementing health IT systems in 

office-based medical practices, recognized the complicating factors of EHR types, available 

features and differences in characteristics of the practices that are adopting them. The CBO 

estimated a cost range of $25,000 to $45,000 per physician. Annual operating and maintenance 

amount was estimated at 12 to 20 percent of initial costs (that is, $3,000 to $9,000) per physician. 

For all eligible hospitals, the range is from $1 million to $100 million. Though reports vary 

widely, we anticipate that the average will be $5 million for eligible hospitals to achieve 

meaningful use. We estimate $1 million for maintenance, upgrades, and training each year per 

eligible hospital. However, as stated earlier many providers have already purchased systems 

with expenditures focused on maintenance and upgrades. We believe that future retrospective 

studies on the costs to implement and EHR and the return on investment (ROI) will demonstrate 

the actual costs incurred by providers participating in the EHR Incentive Programs.
CMS-3310-P 242

(2) Conclusion

As discussed later in this analysis, we believe that there are many positive effects of 

adopting EHR on health care providers. We believe that the net effect on some individual 

providers may be positive. Accordingly, we believe that the object of the RFA to minimize 

burden on small entities is met by this proposed rule. 

b. Small Rural Hospitals

Section 1102(b) of the Act requires us to prepare a regulatory impact analysis (RIA) if a 

rule will have a significant impact on the operations of a substantial number of small rural 

hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes 

of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside 

of a metropolitan statistical area and has fewer than 100 beds. This proposed rule would affect 

the operations of a substantial number of small rural hospitals because they may be subject to 

adjusted Medicare payments in 2015 if they fail to adopt certified EHR technology by the 

applicable reporting period. As stated previously, we have determined that this proposed rule 

would create a significant impact on a substantial number of small entities, and have prepared a 

Regulatory Flexibility Analysis as required by the RFA and, for small rural hospitals, section 

1102(b) of the Act. Furthermore, any impacts that would arise from the implementation of 

certified EHR technology in a rural eligible hospital would be positive, with respect to the 

streamlining of care and the ease of sharing information with other EPs to avoid delays, 

duplication, or errors. However, the Secretary retains the discretionary statutory authority to 

make case-by-case exceptions for significant hardships, and has already established certain 

categories where case-by-case applications may be made such as barriers to internet connectivity 

that impact health information exchange.
CMS-3310-P 243

c. Unfunded Mandates Reform Act

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that 

agencies assess anticipated costs and benefits before issuing any rule whose mandates will 

require spending in any 1 year $100 million in 1995 dollars, updated annually for inflation. In 

2014, that threshold is approximately $141 million. UMRA does not address the total cost of a 

rule. Rather, it focuses on certain categories of cost, mainly those "federal mandate" costs 

resulting from-- (1) imposing enforceable duties on state, local, or tribal governments, or on the 

private sector; or (2) increasing the stringency of conditions in, or decreasing the funding of, 

state, local, or tribal governments under entitlement programs. 

This proposed rule imposes no substantial mandates on states. This program is voluntary 

for states and states offer the incentives at their option. The state role in the incentive program is 

essentially to administer the Medicaid incentive program. While this entails certain procedural 

responsibilities, these do not involve substantial state expense. In general, each state Medicaid 

Agency that participates in the incentive program would be required to invest in systems and 

technology to comply. States would have to identify and educate providers, evaluate their 

attestations and pay the incentive. However, the federal government would fund 90 percent of 

the state's related administrative costs, providing controls on the total state outlay. 

The investments needed to meet the meaningful use standards and obtain incentive 

funding are voluntary, and hence not "mandates" within the meaning of the statute. However, 

the potential reductions in Medicare reimbursement beginning with FY 2015 would have a 

negative impact on providers that fail to meaningfully use certified EHR technology for the 

applicable reporting period. We note that we have no discretion as to the amount of those 

potential payment reductions. Private sector EPs that voluntarily choose not to participate in the 
CMS-3310-P 244

program may anticipate potential costs in the aggregate that may exceed $141 million. However, 

because EPs may choose for various reasons not to participate in the program, we do not have 

firm data for the percentage of participation within the private sector. This RIA, taken together 

with the remainder of the preamble, constitutes the analysis required by UMRA. 

d. Federalism

Executive Order 13132 establishes certain requirements that an agency must meet when it 

promulgates a final rule that imposes substantial direct requirement costs on state and local 

governments, preempts state law, or otherwise has federalism implications. This proposed rule 

will not have a substantial direct effect on state or local governments, preempt state law, or 

otherwise have a federalism implication. Importantly, state Medicaid agencies are receiving 

100 percent match from the federal government for incentives paid and a 90-percent match for 

expenses associated with administering the program. As previously stated, we believe that state 

administrative costs are minimal. We note that this proposed rule does add a new business 

requirement for states, because of the existing systems that would need to be modified to track 

and report on the new meaningful use requirements for provider attestations. We are providing 

90-percent FFP to states for modifying their existing EHR Incentive Program systems. We 

believe the federal share of the 90-percent match will protect the states from burdensome 

financial outlays and as noted previously, states offer the Medicaid EHR incentive program at 

their option. 

2. Effects on EPs, Eligible Hospitals, and CAHs

a. Background and Assumptions

The principal costs of this proposed rule are the additional expenditures that will be 

undertaken by eligible entities in order to obtain the Medicare and Medicaid incentive payments 
CMS-3310-P 245

to adopt, implement or upgrade and/or demonstrate meaningful use of certified EHR technology, 

and to avoid the Medicare payment adjustments that will ensue if they fail to do so. The 

estimates for the provisions affecting Medicare and Medicaid EPs, eligible hospitals, and CAHs 

are somewhat uncertain for several reasons: (1) the program is voluntary although payment 

adjustments will be imposed on Medicare providers beginning in 2015 if they are unable to 

demonstrate meaningful use for the applicable reporting period; (2) the criteria for the 

demonstration of meaningful use of certified EHR technology has been finalized for Stage 1 and 

Stage 2 and is being proposed for Stage 3, but may change over time; and (3) the impact of the 

financial incentives and payment adjustments on the rate of adoption of certified EHR 

technology by EPs, eligible hospitals, and CAHs is difficult to predict based on the information 

we have currently collected. The net costs and savings shown for this program represent a 

possible scenario and actual impacts could differ substantially. 

Based on input from a number of internal and external sources, we estimated the numbers 

of EPs and eligible hospitals, including CAHs under Medicare, Medicaid, and MA and used 

them throughout the analysis. 

● About 675,500 Medicare FFS EPs in 2017 (some of whom will also be Medicaid EPs).

● About 60,600 non-Medicare eligible EPs (such as dentists, pediatricians, and eligible 

non-physicians such as certified nurse-midwives, nurse practitioners, and physicians assistants) 

could be eligible to receive the Medicaid incentive payments in 2017.

● 4,900 eligible hospitals comprising the following:

++ 3,397 acute care hospitals

++ 1,395 CAHs

++ 97 children's hospitals (Medicaid only)
CMS-3310-P 246

++ 11 cancer hospitals (Medicaid only)

● All eligible hospitals, except for children's and cancer hospitals, may qualify and apply 

for both Medicare and Medicaid incentive payments.

● About 16 MA organizations

b. Industry Costs and Adoption Rates

In the Stage 2 final rule (77 FR 54136 through 54146), we estimated the impact on health

care providers using information from four studies. In the absence of any more recent estimates 

that we are aware of, in this proposed rule, we continue to use the same estimates cited in the 

Stage 2 final rule. We continue to believe that these estimates are reasonably reflective of EHR 

costs. However, we note, we are unable to delineate all costs due to the great variability in 

characteristics among the entities that are affected by the proposed rule; the variability includes, 

but is not limited to, the size of the practice, extent of use of electronic systems, type of system 

used, number of staff using the EHR system and the cost for maintaining and/or upgrading 

systems. Based on these studies and current average costs for available certified EHR 

technology products, we continue to estimate for EPs that the average adopt/implement/upgrade 

cost is $54,000 per physician FTE, while annual maintenance costs average $10,000 per 

physician FTE. 

For all eligible hospitals, we continue to estimate the range is from $1 million to 

$100 million. Although reports vary widely, we continue to anticipate that the average will be 

$5 million to achieve meaningful use, because providers who will like to qualify as meaningful 

users of EHRs will need to purchase certified EHRs. We further acknowledge "certified EHRs"

may differ in many important respects from the EHRs currently in use and may differ in the 

functionalities they contain. We continue to estimate $1 million for maintenance, upgrades, and 
CMS-3310-P 247

training each year. Both of these estimates are based on average figures provided in the 2008 

CBO report. However, as noted previously, we are unable to delineate all costs due to the great 

variability in characteristics among the entities that are affected by the proposed rule; the 

variability includes, but is not limited to, the size of the hospital, extent of use of electronic 

systems, type of system used, number of staff using the EHR system and the cost for maintaining 

and/or upgrading systems.

Industry costs are important, in part, because EHR adoption rates will be a function of 

these industry costs and the extent to which the costs of "certified EHRs" are higher than the 

total value of EHR incentive payments available to EPs and eligible hospitals (as well as 

adjustments, in the case of the Medicare EHR incentive program) and any perceived benefits 

including societal benefits. Because of the uncertainties surrounding industry cost estimates, we 

have made various assumptions about adoption rates in the following analysis in order to 

estimate the budgetary impact on the Medicare and Medicaid programs. 

c. Costs of EHR Adoption for EPs

Since the publication of the Stage 1 final rule, there has been little data published 

regarding the cost of EHR adoption and implementation. A 2011 study 

(http://content.healthaffairs.org/content/30/3/481.abstract) estimated costs of implementation for 

a five-physician practice to be $162,000, with $85,500 in maintenance expenses in the first year. 

In the absence of additional data regarding the cost of adoption and implementation costs for 

certified EHR technology, we proposed to continue to estimate for EPs that the average 

adopt/implement/upgrade cost is $54,000 per physician FTE, while annual maintenance costs 

average $10,000 per physician FTE, based on the cost estimate of the Stage 1 final rule.

However, as noted previously, we are unable to delineate all costs due to the great variability that 
CMS-3310-P 248

are affected by but not limited to the size of the practice, extent of use of electronic systems, type 

of system used, number of staff using the EHR system, and the cost for maintaining and/or 

upgrading systems.

d. Costs of EHR Adoption for Eligible Hospitals 

According to the American Hospital Association 2008 Survey, the range in yearly 

information technology spending among hospitals ranged from $36,000 to over $32 million. 

EHR system costs specifically were reported by other experts to run as high as $20 million to 

$100 million (77 FR 54139). We note that recently we have seen about 96 percent of eligible

hospitals have received at least one incentive payment under either the Medicare or Medicaid 

programs. However, as noted previously, we are unable to delineate all costs due to the great 

variability that are affected by but not limited to the size of the eligible hospital, extent of use of 

electronic systems, type of system used, number of staff using the EHR system, and the cost for 

maintaining and/or upgrading systems.

3. Medicare Incentive Program Costs

The estimates for the HITECH Act provisions are based on the economic assumptions 

underlying the President's FY 2016 Budget. Under the statute, Medicare incentive payments for 

certified EHR technology are excluded from the determination of MA capitation benchmarks. 

We continue to expect a negligible impact on benefit payments to hospitals and EPs from 

Medicare and Medicaid because of the implementation of EHR technology. 

As noted at the beginning of this analysis, it is difficult to predict the actual impacts of 

the HITECH Act with great certainty. We believe the assumptions and methods described herein 

are reasonable for estimating the financial impact of the provisions on the Medicare and 

Medicaid programs, but acknowledge the wide range of possible outcomes. 
CMS-3310-P 249

a. Medicare Eligible Professionals (EPs)

We began making EHR Incentive payments in 2011. Medicare payments are to be paid 

for the successful demonstration on meaningful use through CY 2016. Due to the payment lag, 

some payments may be issued in CY 2017. To avoid the Medicare payment adjustment

beginning in 2015, EPs need to successfully demonstrate meaningful use regardless of whether 

they earn an incentive payment. We estimated the percentage of the remaining EPs who would

be meaningful users each calendar year. Table 8 shows the results of these calculations.

TABLE 8: MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF CERTIFIED 

EHR TECHNOLOGY

Calendar year

2017 2018 2019 2020

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

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

Percent of EPs who are Meaningful Users 70 73 75 78

Meaningful Users (thousands) 426.4 446.7 467.3 488.3

Our estimates of the incentive payment costs and payment adjustment savings are 

presented in Table 9. They reflect actual historical data and our assumptions about the 

proportion of EPs who will demonstrate meaningful use of certified EHR technology. Estimated 

costs are expected to decrease in 2017 through 2020 due to a smaller number of new EPs that 

would achieve meaningful use and the cessation of the incentive payment program. Payment 

adjustment receipts represent the estimated amount of money collected due to the payment 

adjustments for those not achieving meaningful use. Estimated net costs for the Medicare EP 

portion of the HITECH Act are also shown in Table 9. 
CMS-3310-P 250

TABLE 9: ESTIMATED COSTS (+) AND SAVINGS (–) FOR MEDICARE

EPS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR

TECHNOLOGY (IN BILLIONS)

Fiscal Year Incentive

Payments

Payment 

Adjustment

Receipts

Benefit 

Payments Net Total

2017 $0.6 –$0.2 — $0.3

2018 — –$0.2 — –$0.2

2019 — –$0.2 — –$0.2

2020 — –$0.1 — –$0.1

b. Medicare Eligible Hospitals and CAHs

In brief, the estimates of hospital adoption were developed by calculating projected 

incentive payments and then making assumptions about how rapidly hospitals would adopt 

meaningful use. 

Specifically, the first step in preparing estimates of Medicare program costs for eligible 

hospitals was to determine how many eligible hospitals already received payments under the 

EHR Incentive program and for what years those payments were received. In order to do this,

we used the most recent available data that listed the recipients of incentive payments, and the

year and payment amount. This information pertained to eligible hospitals receiving payments 

through September 2014. 

We assume that all eligible hospitals that receive a payment in the first year will receive 

payments in future years. We also assume the eligible hospitals that have not yet received any 

incentive payments will eventually achieve meaningful use (either to receive incentive payments

or to avoid payment adjustments). We assume that all eligible hospitals would achieve 

meaningful use by 2018. No new incentive payments would be paid after 2016. However, some 

incentive payments originating in 2016 would be paid in 2017.
CMS-3310-P 251

The average incentive payment for each eligible hospital was $1.5 million in the first 

year. In later years, the amount of the incentive payments drops according to the schedule 

allowed in law. The average incentive payment for CAHs received in the first year was about 

$950,000. The average incentive payment received in the second year was about $332,500. The 

average incentive payment received in the third year was about $475,000. These average 

amounts were used for these incentive payments in the future. The third year average was also 

used for the fourth year. These assumptions about the number of hospitals achieving meaningful 

use in a particular year and the average amount of an incentive payment allows us to calculate 

the total amount of incentive payments to be made and the amount of payment adjustments for 

those hospitals who have not achieved meaningful use. The payment incentives available to 

hospitals under the Medicare and Medicaid EHR Incentive Programs are included in our 

regulations at 42 CFR part 495. We further estimate that there are 16 MA organizations that 

might be eligible to participate in the incentive program. Those plans have 32 eligible hospitals. 

The costs for the MA program have been included in the overall Medicare estimates. 

The estimated payments to eligible hospitals were calculated based on the hospitals'

qualifying status and individual incentive amounts under the statutory formula. Similarly, the 

estimated payment adjustments for non-qualifying hospitals were based on the market basket 

reductions and Medicare revenues. The estimated savings in Medicare eligible hospital benefit 

expenditures resulting from the use of hospital certified EHR systems were discussed earlier in 

this section. We assumed no future growth in the total number of hospitals in the U.S. because 

growth in acute care hospitals has been minimal in recent years. The results are shown in

Table 10.
CMS-3310-P 252

TABLE 10: ESTIMATED COSTS (+) AND SAVINGS (-) FOR MEDICARE 

ELIGIBLE HOSPITALS DEMONSTRATING MEANINGFUL 

USE OF CERTIFIED EHR TECHNOLOGY

(in billions)

Fiscal Year

Incentive 

payments

Payment 

adjustment 

receipts

Benefit 

payments Net Total

2017 $1.6 (

1

) (

1

) $1.6

2018 0.0 (

1

) (

1

) (

1

)

2019 0.0 0.0 (

1

) (

1

)

2020 0.0 0.0 (

1

) (

1

)

1

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

4. Medicaid Incentive Program Costs

Under section, 4201 of the HITECH Act, states and territories can voluntarily participate 

in the Medicaid EHR Incentive Program. However, as of the writing of this proposed rule, all 

states already participate. The payment incentives available to EPs and eligible hospitals under 

the Medicaid EHR Incentive Program are included in our regulations at 42 CFR part 495. The 

federal costs for Medicaid incentive payments to providers who can demonstrate meaningful use 

of EHR technology were estimated similarly to the estimates for Medicare eligible hospitals and 

EPs. Table 11 shows our estimates for the net Medicaid costs for eligible hospitals and EPs. 

TABLE 11: ESTIMATED FEDERAL COSTS (+) AND SAVINGS (–) UNDER 

MEDICAID, (In $Billions)

Fiscal Year

Incentive Payments

Benefit 

Hospitals Payments Net Total

Eligible 

Professionals

2017 0.4 0.8 (1) 1.2

2018 0.1 0.5 (1) 0.6

2019 0 0.3 (1) 0.3

2020 0.0 0.2 (1) 0.2

1

 Savings of less than $50 million.

a. Medicaid EPs 
CMS-3310-P 253

TABLE 12: ASSUMED NUMBER OF NONHOSPITAL BASED MEDICAID EPS WHO 

WOULD BE MEANINGFUL USERS OF CERTIFIED EHR TECHNOLOGY

(Population Figures in Thousands)

Calendar Year

2017 2018 2019 2020

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

B Medicaid only Eps 60.6 61.7 62.9 64.0

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

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

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

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

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

It should be noted that since the Medicaid EHR Incentive Program provides that a 

Medicaid EP can receive an incentive payment in his or her first year because he or she has 

demonstrated a meaningful use or because he or she has adopted, implemented, or upgraded 

certified EHR technology, these participation rates include not only meaningful users but eligible 

providers implementing certified EHR technology as well. 

b. Medicaid Hospitals

Medicaid incentive payments to most eligible hospitals were estimated using the same 

methodology as described previously for Medicare eligible hospitals and shown in Table 10. 

Many eligible hospitals may qualify to receive both the Medicare and Medicaid incentive 

payment. We assume that all eligible hospitals would achieve meaningful use by 2016. 

However, many of these eligible hospitals would have already received the maximum amount of 

incentive payments. Table 13 shows our assumptions about the remaining incentive payments to 

be paid.

TABLE 13: ESTIMATED PERCENTAGE OF HOSPITALS THAT 

COULD BE PAID FOR MEANINGFUL USE AND ESTIMATED 

PERCENTAGE PAYABLE IN YEAR

Fiscal Year Percent of hospitals who 

are Meaningful Users

Percent of Hospitals 

being Paid

2017 100.0 13.5
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2018 100.0 5.2

2019 100.0 1.5

2020 100.0 0.0

As stated previously, the estimated eligible hospital incentive payments were calculated 

based on the eligible hospitals' qualifying status and individual incentive amounts payable under 

the statutory formula. The average Medicaid incentive payment in the first year was $1 million.

The estimated savings in Medicaid benefit expenditures resulting from the use of certified EHR 

technology are discussed in section V.C.4. of this proposed rule. Since we use Medicare data

and little data existed for children's hospitals, we estimated the Medicaid incentives payable to 

children's hospitals as an add-on to the base estimate, using data on the number of children's 

hospitals compared to non-children's hospitals. 

5. Benefits for all EPs and all Eligible Hospitals 

In this proposed rule, we have not quantified the overall benefits to the industry, nor to 

eligible hospitals or EPs in the Medicare, Medicaid, or MA programs. Although information on 

the costs and benefits of adopting systems that specifically meet the requirements for the EHR 

Incentive Programs (for example, certified EHR technology) has not yet been collected, and 

although some studies question the benefits of health information technology, a 2011 study 

completed by ONC (Buntin et al. 2011 "The Benefits of Health Information Technology: A 

Review of the Recent Literature Shows Predominantly Positive Results" Health Affairs.) found 

that 92 percent of articles published from July 2007 up to February 2010 reached conclusions 

that showed the overall positive effects of health information technology on key aspects of care, 

including quality and efficiency of health care. Among the positive results highlighted in these 

articles were decreases in patient mortality, reductions in staffing needs, correlation of clinical 

decision support to reduced transfusion and costs, reduction in complications for patients in 
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hospitals with more advanced health IT, and a reduction in costs for hospitals with less advanced 

health IT. A subsequent 2013 study completed by the RAND Corporation for ONC (Shekelle et 

al. 2013 "Health Information Technology: An Updated Systemic Review with a Focus on

Meaningful Use Functionalities) found 77 percent of articles published between January 2010 to 

August 2013 that evaluated the effects of health IT on healthcare quality, safety, and efficiency 

reported findings that were at least partially positive. The Centers for Disease Control and 

Prevention publication in January 2014, (Hsiao et al, "Use and Characteristics of Electronic 

Health Record Systems Among Office-based Physician Practices: United states, 2001-2013") 

concluded that the adoption of basic EHR systems by office-based physicians increased 

21 percent between 2012 and 2013, varying widely across the states ranging from 21 percent in 

New Jersey to 83 percent in North Dakota. Another study, at one hospital emergency room in 

Delaware, showed the ability to download and create a file with a patient's medical history saved 

the ER $545 per use, mostly in reduced waiting times. A pilot study of ambulatory practices 

found a positive ROI within 16 months and annual savings thereafter (Greiger et al. 2007, A

Pilot Study to Document the Return on Investment for Implementing an Ambulatory Electronic 

Health Record at an Academic Medical Center http://www.journalacs.org/article/S1072-

7515%2807%2900390-0/abstract - article-footnote-1.) Another study compared the productivity 

of 75 providers within a large urban primary care practice over a 4-year period showed increases 

in productivity of 1.7 percent per month per provider after EHR adoption (DeLeon et al. 2010, 

"The business end of health information technology"). Some vendors have estimated that EHRs 

could result in cost savings of between $100 and $200 per patient per year. As participation and 

adoption increases, there will be more opportunities to capture and report on cost savings and 

benefits. 
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6. Benefits to Society

According to the CBO study "Evidence on the Costs and Benefits of Health Information 

Technology" (http://www.cbo.gov//ftpdocs/91xx/doc9168/05-20-HealthIT.pdf) when used 

effectively, EHRs can enable providers to deliver health care more efficiently. For example, the 

study states that EHRs can reduce the duplication of diagnostic tests, prompt providers to 

prescribe cost-effective generic medications, remind patients about preventive care, reduce 

unnecessary office visits, and assist in managing complex care. This is consistent with the 

findings in the ONC study cited previously. Further, the CBO report claims that there is a 

potential to gain both internal and external savings from widespread adoption of health IT, 

noting that internal savings will likely be in the reductions in the cost of providing care, and that 

external savings could accrue to the health insurance plan or even the patient, such as the ability 

to exchange information more efficiently. However, it is important to note that the CBO 

identifies the highest gains accruing to large provider systems and groups and claims that 

office-based physicians may not realize similar benefits from purchasing health IT products. At 

this time, there is limited data regarding the efficacy of health IT for smaller practices and 

groups, and the CBO report notes that this is a potential area of research and analysis that 

remains unexamined. The benefits resulting specifically from this proposed rule are even harder 

to quantify because they represent, in many cases, adding functionality to existing systems and 

reaping the network externalities created by larger numbers of providers participating in 

information exchange. 

In the Stage 2 final rule at 77 FR 54144, we discussed research documenting the 

association of EHRs with improved outcomes among diabetics (Hunt, JS et al. (2009) "The 

impact of a physician-directed health information technology system on diabetes outcomes in 
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primary care: a pre- and post-implementation study" Informatics in Primary Care 17(3): 

165-74; Pollard, C et al. (2009) "Electronic patient registries improve diabetes care and clinical 

outcomes in rural community health centers" Journal of Rural Health 25(1): 77-84) and trauma 

patients (Deckelbaum, D. et al. (2009) "Electronic medical records and mortality in trauma 

patients "The Journal of Trauma: Injury, Infection, and Critical Care 67(3): 634-636), enhanced 

efficiencies in ambulatory care settings (Chen, C et al. (2009) "The Kaiser Permanente 

Electronic Health Record: Transforming and Streamlining Modalities Of Care. "Health Affairs"

28(2): 323-333), and improved outcomes and lower costs in hospitals (Amarasingham, R. et al. 

(2009) "Clinical information technologies and inpatient outcomes: a multiple hospital study"

Archives of Internal Medicine 169(2): 108–14). The 2013 ONC report cited previously reported 

findings from their literature review on health IT and safety of care, health IT and quality of care, 

health IT and safety of care, and health It and efficiency of care in ambulatory and 

non-ambulatory care settings. The report indicated that a majority of studies that evaluated the 

effects of health IT on healthcare quality, safety, and efficiency reported findings that were at 

least partially positive. The report concluded that their findings "suggested that health IT, 

particularly those functionalities included in the Meaningful Use..., can improve healthcare 

quality and safety." However, data relating specifically to the EHR Incentive Programs is 

limited at this time.

7. Summary 

In this proposed rule, the total cost to the Medicare and Medicaid programs between 2017 

and 2020 is estimated to be $3.7 billion in transfers. As discussed in section V.C.4. of this 

proposed rule, we do not estimate total costs to the provider industry, but rather provide a 

possible per EP and per eligible hospital outlay for implementation and maintenance.
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TABLE 14: ESTIMATED EHR INCENTIVE PAYMENTS AND BENEFITS IMPACTS 

ON THE MEDICARE AND MEDICAID PROGRAMS OF THE HITECH EHR 

INCENTIVE PROGRAM. (FISCAL YEAR) 

(in billions) 

Fiscal 

Year

Medicare Eligible Medicaid Eligible

Hospitals Professionals Hospitals Professionals Total

2017 $1.6 $0.3 $0.4 $0.8 $3.1

2018 $0.0 -$0.2 $0.1 $0.5 $0.4

2019 $0.0 -$0.2 $0.0 $0.3 $0.1

2020 $0.0 -$0.1 $0.0 $0.2 $0.1

Total $1.6 $-0.2 $0.5 $1.8 $3.7

D. Alternatives Considered

As stated in the Stage 1 final rule (75 FR 44546), HHS has no discretion to change the 

incentive payments or payment adjustment reductions specified in the statute for providers that 

adopt or fail to adopt a certified EHR and demonstrate meaningful use of certified EHR 

technology. However, we have discretion around how best to meet the HITECH Act 

requirements for meaningful use for FY 2017 and subsequent years, which we have exercised in 

this proposed rule. Additionally, we have used our discretion to appropriately propose the timing 

of registration, attestation and payment requirements to allow EPs and eligible organizations as 

much time as possible in coordination with the anticipated certification of EHR technology to 

obtain and meaningfully use certified EHRs. We recognize that there may be additional costs 

that result from various discretionary policy choices by providers. However, those costs cannot 

be estimated and are not captured in this analysis.

E. Accounting Statement and Table

Whenever a rule is considered a significant rule under Executive Order 12866, we are 

required to develop an accounting statement indicating the classification of the expenditures 

associated with the provisions of this proposed rule. Monetary annualized benefits and non-
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budgetary costs are presented as discounted flows using 3 percent and 7 percent factors in the 

following Table 15. We are not able to explicitly define the universe of those additional costs, 

nor specify what the high or low range might be to implement EHR technology in this proposed 

rule. We note that federal annualized monetized transfers represent the net total of annual 

incentive payments in the Medicare and Medicaid EHR Incentive programs less the reductions in 

Medicare payments to providers failing to demonstrate meaningful use as a result of the related 

Medicare payment adjustments. 

Expected qualitative benefits include improved quality of care, better health outcomes, 

reduced errors and the like. Private industry costs would include the impact of EHR activities 

such as temporary reduced staff productivity related to learning how to use the EHR, the need for 

additional staff to work with HIT issues, and administrative costs related to reporting.
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TABLE 15: ACCOUNTING STATEMENT:

CLASSIFICATION OF ESTIMATED EXPENDITURES CYs 2017 THROUGH 2020 

(in millions)

CATEGORY

BENEFITS

Qualitative Expected qualitative benefits include improved quality of care, better 

health outcomes, reduced errors and the like.

COSTS

Year 

Dollar

Estimates

(in millions)

Unit 

Discount 

Rate Period Covered

Primary Estimate

Annualized Monetized Costs to Private Industry 

Associated with Reporting Requirements

2017 $478.1 7% CY 2017

$478.4 3%

Qualitative--Other private industry costs 

associated with the adoption of EHR technology.

These costs would include the impact of EHR activities such as 

reduced staff productivity related to learning how to use the EHR 

technology, the need for additional staff to work with HIT issues, 

and administrative costs related to reporting.

TRANSFERS

Year 

Dollar

Estimates

(in millions)

Unit 

Discount 

Rate Period Covered

Federal Annualized Monetized 2017 $1,000.4 7% CYs 2017-2020

$954.8 3%

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

professionals and hospitals

F. Conclusion

The previous analysis, together with the remainder of this preamble, provides an RIA. 

We believe there are many positive effects of adopting EHR on health care providers. We 

believe there are benefits that can be obtained by eligible hospitals and EPs, including: 

reductions in medical recordkeeping costs, reductions in repeat tests, decreases in length of stay, 

and reduced errors. Health IT can enable providers to deliver health care more efficiently. For 

example, EHRs can reduce the duplication of diagnostic tests, prompt providers to prescribe 

cost-effective generic medications, remind patients about preventive care, reduce unnecessary 

office visits, and assist in managing complex care. We also believe that internal savings will 

likely come through the reductions in the cost of providing care. We believe that the net effect 
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on individual providers may be positive over time in many cases. Accordingly, we believe that 

the object of the Regulatory Flexibility Analysis to minimize burden on small entities are met by 

this proposed rule. We invite public comments on the analysis and request any additional data 

that would help us determine more accurately the impact on the EPs and eligible hospitals 

affected by the proposed rule.

In accordance with the provisions of Executive Order 12866, the Office of Management 

and Budget reviewed this rule. 
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List of Subjects 

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. 
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For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services 

proposes to amend 42 CFR part 495 as set forth below:

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD 

TECHNOLOGY INCENTIVE PROGRAM

1. The authority citation for part 495 continues to read as follows: 

Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 

1395hh).

2. Section 495.4 is amended as follows: 

A. Adding the definition for “Application-program interface (API)”.

B. Revising the definition of "Certified electronic health record technology".

C. Amending the definition of "EHR reporting period" by--

i. Redesignating paragraphs (1)(i), (1)(ii), (1)(iii) introductory text, (1)(iii)(A), 

(1)(iii)(B), (1)(iii)(C), (1)(iii)(D), and (1)(iv) as paragraphs (1)(i)(A) , (1)(i)(B), (1)(i)(C) 

introductory text, (1)(i)(C)(1), (1)(i)(C)(2), (1)(i)(C)(3), (1)(1)(C)(4), and (1)(i)(D), respectively.

ii. Adding new paragraph (1)(i) introductory text.

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

iv Redesignating paragraphs (2)(i), (2)(ii), (2)(iii) introductory text, (2)(iii)(A), 

(2)(iii)(B), (2)(iii)(C), and (2)(iii)(D), as paragraphs (2)(i)(A), (2)(i)(B), (2)(i)(C) introductory 

text and (2)(i)(C)(1), (2)(i)(C)(2), (2)(i)(C)(3), and (2)(i)(C)(4), respectively.

v. Adding new paragraph (2)(i) introductory text. 

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

D. Amending the definition of "EHR reporting period for a payment adjustment year"

by:
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i. Redesignating paragraphs (1)(i)(A), (1)(i)(B), (1)(ii), (1)(iii)(A), and (1)(iii)(B) as 

paragraphs (1)(i)(A)(1), (1)(i)(A)(2), (1)(i)(B), (1)(i)(C)(1) and (1)(i)(C)(2), respectively.

ii. In newly redesignated paragraph (1)(i)(A)(1), by removing the cross-reference 

"paragraphs (1)(i)(B), (ii), and (iii)" and adding in its place the cross-reference "paragraphs 

(1)(i)(A)(2), (1)(i)(B), and (1)(i)(C)".

iii. In newly redesignated paragraph (1)(i)(A)(2), by removing the cross-reference 

"paragraphs (1)(iii) or (iv)" and adding in its place the cross-reference "paragraph (1)(i)(C)".

iv. Adding new paragraph (1)(i) introductory text.

v. Adding a new paragraph (1)(ii).

vi. Redesignating paragraphs (2)(i)(A), (2)(i)(B), (2)(ii), (2)(iii)(A), and (2)(iii)(B) as 

paragraphs (2)(i)(A)(1), (2)(i)(A)(2), (2)(i)(B), (2)(i)(C)(1) and (2)(i)(C)(2), respectively.

vii. In newly redesignated paragraph (2)(i)(A)(1), by removing the cross-reference 

"paragraphs (2)(i)(B), (ii), and (iii)" and adding in its place the cross-reference "paragraphs 

(2)(i)(A)(2), (2)(i)(B), and (2)(i)(C)".

viii. In newly redesignated paragraph (2)(i)(A)(2), by removing the cross-reference 

"paragraph (2)(iii)" and adding in its place the cross-reference "paragraph (2)(i)(C)".

ix. Adding new paragraph (2)(i) introductory text.

x. Adding new paragraph (2)(ii).

xi. Redesignating paragraphs (3)(i) and (3)(ii) as paragraphs (3)(i)(A) and (3)(i)(B).

xii. In newly redesignated paragraph (3)(i)(A), by removing the cross-reference 

"paragraph (3)(ii)" and adding in its place the cross-reference "paragraph (3)(i)(B)".

xiii. Adding new paragraph (3)(i) introductory text.

xiv. Adding new paragraph (3)(ii).
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E. In the paragraph (1) of the definition of "Meaningful EHR User" by removing the 

reference "under §495.6" and adding in its place the reference to "under §495.6 or 495.7". 

The additions read as follows: 

§495.4 Definitions.

* * * * *

Application-program interface (API) means a set of programming protocols established 

for multiple purposes. APIs may be enabled by a provider or provider organization to provide 

the patient with access to their health information through a third-party application with more 

flexibility than often found in many current "patient portals." 

Certified electronic health record technology (CEHRT) means the following:

(1) For any Federal fiscal year (FY) or calendar year (CY) before 2018, EHR technology 

(which could include multiple technologies) certified under the ONC Health IT Certification 

Program that--

(i) Meets the--

(A) 2014 Edition Base EHR definition (as defined at 45 CFR 170.102); or

(B) 2015 Edition Base EHR definition (as defined at 45 CFR 170.102); or

(ii) Has been certified to the following certification criteria:

(A)(1) CPOE at--

(i) 45 CFR 170.314(a)(1), (18), (19) or (20); or

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

(2)(i) Record demographics at 45 CFR 170.314(a)(3); or

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

(3)(i) Problem list at 45 CFR 170.314(a)(5); or
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(ii) 45 CFR 170.315(a)(7).

(4)(i) Medication list at 45 CFR 170.314(a)(6); or 

(ii) 45 CFR 170.315(a)(8).

(5)(i) Medication allergy list 45 CFR 170.314(a)(7); or 

(ii) 45 CFR 170.315(a)(9);

(6)(i) Clinical decision support at 45 CFR 170.314(a)(8); or 

(ii) 45 CFR 170.315(a)(10). 

(7) Health information exchange at transitions of care at one of the following:

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

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

(iii) 45 CFR 170.314(b)(1), (b)(2), and (b)(8). 

(iv) 45 CFR 170.314(b)(1), (b)(2), (b)(8), and (h)(1).

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

(vi) 45 CFR 170.314(b)(1), (b)(2), and 170.315(h)(2).

(vii) 45 CFR 170.314(b)(1), (b)(2), (h)(1), and 170.315(h)(2).

(viii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), and 170.315(h)(2). 

(ix) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), and 170.315(h)(2).

(x) 45 CFR 170.314(b)(8), (h)(1), and 170.315(h)(2).

(xi) 45 CFR 170.314(b)(1), (b)(2), and 170.315(b)(1).

(xii) 45 CFR 170.314(b)(1), (b)(2), (h)(1), and 170.315(b)(1).

(xiii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), and 170.315(b)(1).

(xiv) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), and 170.315(b)(1).

(xv) 45 CFR 170.314(b)(8), (h)(1), and 170.315(b)(1).
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(xvi) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), 170.315(b)(1), and 170.315(h)(1).

(xvii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), 170.315(b)(1), and 170.315(h)(2).

(xviii) 45 CFR 170.314(h)(1) and 170.315(b)(1). 

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

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

(xxi) 45 CFR 170.315(b)(1), (h)(1), and (h)(2). 

(B) Clinical quality measures at 45 CFR 170.314(c)(1) or 170.315(c)(1).

(C) The 2014 Edition or 2015 Edition certification criteria that are necessary to be a 

Meaningful EHR User (as defined in this section), including the following:

(1) The applicable automated numerator recording and automated measure calculation 

certification criteria that support attestation as a Meaningful EHR User at 45 CFR 170.315(g)(1) 

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

(2) Clinical quality measure certification criteria that support the calculation and 

reporting of clinical quality measures at 45 CFR 170.314(c)(2) and (c)(3) or 

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

(2) For 2018 and subsequent years, EHR technology (which could include multiple 

technologies) certified under the ONC Health IT Certification Program that meets the 2015 

Edition Base EHR definition (as defined at 45 CFR 170.102) and has been certified to the 2015 

Edition health IT certification criteria that--

(i)(A) Include the capabilities to record 45 CFR 170.315(a)(14); or 

(B) Create and incorporate family health history 45 CFR 170.315(a)(15).

(ii) Include the capabilities that support patient health information capture at 

45 CFR 170.315(a)(19); and 
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(iii) Are necessary to be a Meaningful EHR User (as defined in this section), including 

the following:

(A) The applicable automated numerator recording and automated measure calculation 

certification criteria that support attestation as a Meaningful EHR User at 45 CFR 170.315(g)(1) 

and (2).

(B) Clinical quality measure certification criteria that support the calculation and 

reporting of clinical quality measures under the 2015 Edition certification criteria 

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

* * * * *

EHR reporting period. * * *

(1) * * *

(i) The following are applicable before CY 2017.

* * * * *

(ii) The following are applicable beginning in CY 2017 under the Medicaid EHR 

Incentive Program:

(A) For the payment year in which the EP is first demonstrating he or she is a 

meaningful EHR user, any continuous 90-day period within the calendar year. 

(B) For the subsequent payment years following the payment year in which the EP first 

successfully demonstrates he or she is a meaningful EHR user, the calendar year.

(2) * * *

(i) The following are applicable before CY 2017:

* * * * *

(ii) The following are applicable beginning in CY 2017 under the Medicaid EHR 
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Incentive Program: 

(A) For the payment year in which the eligible hospital or CAH is first demonstrating it 

is a meaningful EHR user, any continuous 90-day period within the calendar year.

(B) For the subsequent payment years following the payment year in which the eligible 

hospital or CAH first successfully demonstrates it is a meaningful EHR user, the calendar year.

EHR reporting period for a payment adjustment year. * * *

(1) * * *

(i) The following are applicable before CY 2017:

* * * * *

(ii) The following are applicable beginning in CY 2017:

(A) Except as provided under paragraph (1)(ii)(B) of this definition, the calendar year 

that is 2 years before the payment adjustment year. 

(B) If an EP is demonstrating under the Medicaid EHR Incentive Program that he or she 

is a meaningful EHR user for the first time in the calendar year that is 2 years before the payment 

adjustment year, then the continuous 90-day period that is the EHR reporting period for the 

Medicaid incentive payment within such (2 years prior) calendar year.

(2) * * *

(i) The following are applicable before CY 2017:

* * * * *

(ii) The following are applicable beginning in CY 2017:

(A) Except as provided in paragraph (2)(ii)(B) of this definition, the calendar year that is 

2 years before the payment adjustment year. 
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(B) If an eligible hospital is demonstrating under the Medicaid EHR Incentive Program 

that it is a meaningful EHR user for the first time in the calendar year that is 2 years before the 

payment adjustment year, then the continuous 90-day period that is the EHR reporting period for 

the Medicaid incentive payment within such (2 years prior) calendar year.

(3) * * *

(i) The following are applicable before CY 2017:

* * * * *

(ii) The following are applicable beginning in CY 2017:

(A) Except as provided in paragraph (3)(ii)(B) of this definition, the calendar year that 

begins on the first day of the second quarter of the Federal fiscal year that is the payment 

adjustment year. 

(B) If a CAH is demonstrating under the Medicaid EHR Incentive Program that it is a 

meaningful EHR user for the first time in the calendar year that begins on the first day of the 

second quarter of the Federal fiscal year that is the payment adjustment year, then any 

continuous 90-day period within such calendar year.

* * * * *

3. Section 495.6 is amended by revising the section heading and adding introductory text 

to read as follows: 

§ 495.6 Meaningful use objectives and measures for EPs, eligible hospitals, and CAHs 

before 2018.

The following criteria are applicable before 2018:

* * * *

4. Section 495.7 is added to read as follows: 
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§ 495.7 Stage 3 meaningful use objectives and measures for EPs, eligible hospitals, and 

CAHs for 2018 and subsequent years.

The following criteria are optional for EPs, eligible hospitals, and CAHs in 2017 as 

outlined at § 495.8(a)(2)(i)(E)(3) and (b)(2)(E)(3) and applicable for all EPs, eligible hospitals, 

and CAHs for 2018 and subsequent years:

(a) Stage 3 criteria for EPs.

(1) General rule regarding Stage 3 criteria for meaningful use for EPs. Except as 

specified in paragraphs (a)(2) through (a)(3) of this section, EPs must meet all objectives and 

associated measures of the Stage 3 criteria specified in paragraph (d) of this section to meet the 

definition of a meaningful EHR user.

(2) Selection of measures for specified objectives in paragraph (d) of this section. An EP 

may meet the criteria for 2 out of the 3 measures associated with an objective, rather than 

meeting the criteria for all 3 of the measures, if the EP meets all of the following requirements: 

(i) Must ensure that the objective in paragraph (d) of this section includes an option to 

meet 2 out of the 3 associated measures.

(ii) Meets the threshold for 2 out of the 3 measures for that objective.

(iii) Attests to all 3 of the measures for that objective 

(3) Exclusion for nonapplicable objectives and measures. 

(i) An EP may exclude a particular objective that includes an option for exclusion 

contained in paragraph (d) of this section, if the EP meets all of the following requirements: 

(A) Meets the criteria in the applicable objective that would permit the exclusion.

(B) Attests to the exclusion.
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(ii) An EP may exclude a measure within an objective which allows for a provider to 

meet the threshold for 2 of the 3 measures, as outlined in paragraph (a)(2) of this section, in the 

following manner:

(A)(1) Meets the criteria in the applicable measure or measures that would permit the 

exlusion; and 

(2) Attests to the exclusion or exclusions. 

(B)(1) Meets the threshold; and 

(2) Attests to any remaining measure or measures. 

(4) Exception for Medicaid EPs who adopt, implement or upgrade in their first payment 

year. For Medicaid EPs who adopt, implement or upgrade its certified EHR technology in their 

first payment year, the meaningful use objectives and associated measures of the Stage 3 criteria 

specified in paragraph (d) of this section, apply beginning with the second payment year, and do 

not apply to the first payment year.

(b) Stage 3 criteria for eligible hospitals and CAHs.

(1) General rule regarding Stage 3 criteria for meaningful use for eligible hospitals or 

CAHs. Except as specified in paragraphs (b)(2) through (b)(3) of this section, eligible hospitals 

and CAHs must meet all objectives and associated measures of the Stage 3 criteria specified in 

paragraph (d) of this section to meet the definition of a meaningful EHR user.

(2) Selection of measures for specified objectives in paragraph (d) of this section. An 

eligible hospital or CAH may meet the criteria for 2 out of the 3 measures associated with an 

objective, rather than meeting the criteria for all 3 of the measures, if the eligible hospital or 

CAH meets all of the following requirements: 
CMS-3310-P 273

(i) Must ensure that the objective in paragraph (d) of this section includes an option to 

meet 2 out of the 3 associated measures.

(ii) Meets the threshold for 2 out of the 3 measures for that objective.

(iii) Attests to all 3 of the measures for that objective. 

(3) Exclusion for nonapplicable objectives and measures. 

(i) An eligible hospital or CAH may exclude a particular objective that includes an 

option for exclusion contained in paragraph (d) of this section, if the eligible hospital or CAH 

meets all of the following requirements: 

(A) Meets the criteria in the applicable objective that would permit the exclusion.

(B) Attests to the exclusion.

(ii) An eligible hospital or CAH may exclude a measure within an objective which 

allows for a provider to meet the threshold for 2 of the 3 measures, as outlined in paragraph 

(b)(2) of this section, in the following manner:

(A)(1) Meets the criteria in the applicable measure or measures that would permit the 

exclusion; and 

(2) Attests to the exclusion or exclusions. 

(B)(1) Meets the threshold; and 

(2) Attests to any remaining measure or measures. 

(4) Exception for Medicaid eligible hospitals or CAHs that adopt, implement or upgrade 

in their first payment year. For Medicaid eligible hospitals or CAHs who adopt, implement or 

upgrade certified EHR technology in their first payment year, the meaningful use objectives and 

associated measures of the Stage 3 criteria specified in paragraph (d) of this section apply 

beginning with the second payment year, and do not apply to the first payment year.
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(c) Objectives and associated measures in paragraph (d) of this section that rely on 

measures that count unique patients or actions.

(1) If a measure (or associated objective) in paragraph (d) of this section references 

paragraph (c) of this section, then the measure may be calculated by reviewing only the actions 

for patients whose records are maintained using certified EHR technology. A patient's record is 

maintained using certified EHR technology if sufficient data was entered in the certified EHR 

technology to allow the record to be saved, and not rejected due to incomplete data.

(2) If the objective and associated measure does not reference this paragraph (c) of this 

section, then the measure must be calculated by reviewing all patient records, not just those 

maintained using certified EHR technology.

(d) Stage 3 objectives and measures for EPs, eligible hospitals, and CAHs.

(1) Protect patient health information.

(i) EP protect patient health information.

(A) Objective. Protect electronic protected health information (ePHI) created or 

maintained by the certified EHR technology (CEHRT) through the implementation of 

appropriate technical, administrative, and physical safeguards. 

(B) Measure. Conduct or review a security risk analysis in accordance with the 

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

(1) Addressing the security (including encryption) of data stored in CEHRT in 

accordance with requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3),

(2) Implement security updates as necessary, and

(3) Correct identified security deficiencies as part of the EP's risk management process.

(ii) Eligible hospital/CAH protect patient health information.
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(A) Objective. Protect electronic protected health information (ePHI) created or 

maintained by the certified EHR technology (CEHRT) through the implementation of 

appropriate technical, administrative, and physical safeguards.

(B) Measure. Conduct or review a security risk analysis in accordance with the 

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

(1) Addressing the security (including encryption) of data stored in CEHRT in 

accordance with requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3);

(2) Implement security updates as necessary; and

(3) Correct identified security deficiencies as part of the eligible hospital's or CAH's risk 

management process.

(2) Electronic prescribing.

(i) EP electronic prescribing.

(A) Objective. Generate and transmit permissible prescriptions electronically (eRx).

(B) Measure. Subject to paragraph (c) of this section, more than 80 percent of all 

permissible prescriptions written by the EP are queried for a drug formulary and transmitted 

electronically using certified EHR technology (CEHRT).

(C) Exclusions in accordance with paragraph (a)(3) of this section. 

(1) Any EP who writes fewer than 100 permissible prescriptions during the EHR 

reporting period; or

(2) Any EP who does not have a pharmacy within its organization and there are no 

pharmacies that accept electronic prescriptions within 10 miles of the EP's practice location at 

the start of his/her EHR reporting period.

(ii) Eligible hospital/CAH electronic prescribing.
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(A) Objective. Generate and transmit permissible discharge prescriptions electronically 

(eRx).

(B) Measure. Subject to paragraph (c) of this section, more than 25 percent of hospital 

discharge medication orders for permissible prescriptions (for new and changed prescriptions) 

are queried for a drug formulary and transmitted electronically using certified EHR technology

(CEHRT). 

(C) Exclusions in accordance with paragraph (b)(3) of this section. Any eligible hospital 

or CAH that does not have an internal pharmacy that can accept electronic prescriptions and 

there are no pharmacies that accept electronic prescriptions within 10 miles at the start of the 

eligible hospital's or CAH's EHR reporting period.

(3) Clinical decision support.

(i) EP clinical decision support.

(A) Objective. Implement clinical decision support (CDS) interventions focused on 

improving performance on high-priority health conditions.

(B) Measures. 

(1) Implement five clinical decision support interventions related to four or more clinical 

quality measures (CQMs) at a relevant point in patient care for the entire EHR reporting period. 

Absent four clinical quality measures related to an EP's scope of practice or patient population, 

the clinical decision support interventions must be related to high-priority health conditions; and

(2) The EP has enabled and implemented the functionality for drug-drug and drugallergy interaction checks for the entire EHR reporting period.
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(C) Exclusion in accordance with paragraph (a)(3) of this section for paragraph 

(d)(3)(i)(B)(2) of this section. An EP who writes fewer than 100 medication orders during the 

EHR reporting period.

(ii) Eligible hospital/CAH clinical decision support.

(A) Objective. Implement clinical decision support (CDS) interventions focused on 

improving performance on high-priority health conditions.

(B) Measures. 

(1) Implement five clinical decision support interventions related to four or more clinical 

quality measures at a relevant point in patient care for the entire EHR reporting period. Absent 

four clinical quality measures (CQMs) related to an eligible hospital or CAH's patient 

population, the clinical decision support interventions must be related to high-priority health 

conditions; and

(2) The eligible hospital or CAH has enabled and implemented the functionality for 

drug-drug and drug-allergy interaction checks for the entire EHR reporting period.

(4) Computerized provider order entry (CPOE).

(i) EP CPOE.

(A) Objective. Use computerized provider order entry (CPOE) for medication, 

laboratory, and diagnostic imaging orders directly entered by any licensed healthcare 

professional, credentialed medical assistant, or a medical staff member credentialed to and 

performing the equivalent duties of a credentialed medical assistant; who can enter orders into 

the medical record per state, local, and professional guidelines. 

(B) Measures. Subject to paragraph (c) of this section—
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(1) More than 80 percent of medication orders created by the EP during the EHR 

reporting period are recorded using computerized provider order entry;

(2) More than 60 percent of laboratory orders created by the EP during the EHR 

reporting period are recorded using computerized provider order entry; and

(3) More than 60 percent of diagnostic imaging orders created by the EP during the EHR 

reporting period are recorded using computerized provider order entry.

(C) Exclusions in accordance with paragraph (a)(3) of this section. 

(1) For the measure specified in paragraph (d)(4)(i)(B)(1) of this section, any EP who 

writes fewer than 100 medication orders during the EHR reporting period.

(2) For the measure specified in paragraph (d)(4)(i)(B)(2) of this section, any EP who 

writes fewer than 100 laboratory orders during the EHR reporting period.

(3) For the measure specified in paragraph (d)(4)(i)(B)(3) of this section, any EP who 

writes fewer than 100 diagnostic imaging orders during the EHR reporting period.

(ii) Eligible hospital and CAH CPOE.

(A) Objective. Use computerized provider order entry (CPOE) for medication, 

laboratory, and diagnostic imaging orders directly entered by any licensed healthcare 

professional, credentialed medical assistant, or a medical staff member credentialed to and 

performing the equivalent duties of a credentialed medical assistant; who can enter orders into 

the medical record per state, local, and professional guidelines. 

(B) Measures. Subject to paragraph (c) of this section, more than—

(1) Eighty percent of medication orders created by authorized providers of the eligible 

hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting 

period are recorded using computerized provider order entry;
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(2) Sixty percent of laboratory orders created by authorized providers of the eligible 

hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR reporting 

period are recorded using computerized provider order entry; and

(3) Sixty percent of diagnostic imaging orders created by authorized providers of the 

eligible hospital's or CAH's inpatient or emergency department (POS 21 or 23) during the EHR 

reporting period are recorded using computerized provider order entry.

(5) Patient electronic access to health information.

(i) EP patient electronic access to health information.

(A) Objective. The EP provides access for patients to view online, download, and 

transmit their health information, or retrieve their health information through an 

application-program interface (API), within 24 hours of its availability.

(B) Measures. EPs must meet the following two measures:

(1) For more than 80 percent of all unique patients seen by the EP)--

(i) The patient (or patient authorized representatives) is provided access to view online, 

download, and transmit their health information within 24 hours of its availability to the 

provider; or 

(ii) The patient (or patient authorized representatives) is provided access to an 

ONC-certified application-program interface (API) that can be used by third-party applications 

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

information, within 24 hours of its availability to the provider.

(2) The EP must use clinically relevant information from CEHRT to identify patientspecific educational resources and provide electronic access to those materials to more than 

35 percent of unique patients seen by the EP during the EHR reporting period. 
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(C) Exclusions in accordance with paragraph (a)(3) of this section. 

(1) Any EP who has no office visits during the reporting period may exclude from the 

measures specified in paragraphs (d)(7)(i)(B)(1) and (B)(2) of this section.

(2) Any EP that conducts 50 percent or more of his or her patient encounters in a county 

that does not have 50 percent or more of its housing units with 4Mbps broadband availability 

according to the latest information available from the FCC on the first day of the EHR reporting 

period may exclude from the measures specified in paragraphs (d)(7)(i)(B)(1) and (2) of this 

section.

(ii) Eligible hospital and CAH patient electronic access to health information.

(A) Objective. The eligible hospital or CAH provides access for patients to view online, 

download, and transmit their health information, or retrieve their health information through an 

application-program interface (API), within 24 hours of its availability. 

(B) Measures. Eligible hospitals and CAHs must meet the following two measures: 

(1) For more than 80 percent of all unique patients discharged from the eligible hospital 

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

(i) The patient (or patient authorized representatives) is provided access to view online, 

download, and transmit their health information within 24 hours of its availability to the 

provider; or 

(ii) The patient (or patient authorized representatives) is provided access to an 

ONC-certified application-program interface (API) that can be used by third-party applications 

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

information, within 24 hours of its availability to the provider.
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(2) The eligible hospital or CAH must use clinically relevant information from CEHRT 

to identify patient-specific educational resources and provide electronic access to those materials 

to more than 35 percent of unique patients discharged from the eligible hospital or CAH 

inpatient or emergency department (POS 21 or 23) during the EHR reporting period. 

(C) Exclusion in accordance with paragraph (b)(3) of this section. Any eligible hospital 

or CAH that is located in a county that does not have 50 percent or more of its housing units with 

4Mbps broadband availability according to the latest information available from the FCC on the 

first day of the EHR reporting period is excluded from the measures specified in paragraphs 

(d)(7)(ii)(B)(1) and (2) of this section.

(6) Coordination of care through patient engagement.

(i) EP coordination of care through patient engagement.

(A) Objective. Use communications functions of certified EHR technology to engage 

with patients or their authorized representatives about the patient's care. 

(B) Measures. In accordance with paragraph (a)(2) of this section, an EP must satisfy 2 

out of the 3 following measures in paragraphs (d)(5)(i)(B)(1), (2), and (3) of this section except 

those measures for which an EP qualifies for an exclusion under paragraph (a)(3) of this section.

(1) During the EHR reporting period, more than 25 percent of all unique patients seen by 

the EP actively engage with the electronic health record made accessible by the provider. An EP 

may meet measure specified in paragraph (d)(5)(i)(B)(1) of this paragraph by either--

(i) More than 25 percent of all unique patients (or patient-authorized representatives) 

seen by the EP during the EHR reporting period view, download or transmit to a third party their 

health information; or
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(ii) More than 25 percent of all unique patients (or patient-authorized representatives) 

seen by the EP during the EHR reporting period access their health information through the use 

of an ONC-certified API that can be used by third-party applications or devices.

(2) For more than 35 percent of all unique patients seen by the EP during the EHR 

reporting period, a secure message was sent using the electronic messaging function of CEHRT 

to the patient (or their authorized representatives), or in response to a secure message sent by the 

patient.

(3) Patient generated health data or data from a nonclinical setting is incorporated into 

the certified EHR technology for more than 15 percent of all unique patients seen by the EP 

during the EHR reporting period.

(C) Exclusions in accordance with paragraph (a)(3) of this section.

(1) Any EP who has no office visits during the reporting period may exclude from the 

measures specified in paragraphs (d)(5)(i)(B)(1), (B)(2) and (B)(3) of this section.

(2) Any EP that conducts 50 percent or more of his or her patient encounters in a county 

that does not have 50 percent or more of its housing units with 4Mbps broadband availability 

according to the latest information available from the FCC on the first day of the EHR reporting 

period may exclude from the measures specified in paragraphs (d)(5)(i)(B)(1), (B)(2) and (B)(3) 

of this section.

(ii) Eligible hospital and CAH coordination of care through patient engagement.

(A) Objective. Use communications functions of certified EHR technology to engage 

with patients or their authorized representatives about the patient's care. 

(B) Measures. In accordance with paragraph (b)(2) of this section, an eligible hospital or 

CAH must satisfy 2 of the 3 following measures in paragraph (d)(5)(ii)(B)(1), (2), and (3) of this 
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section, except those measures for which an eligible hospital or CAH qualifies for an exclusion 

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

(1) During the EHR reporting period, more than 25 percent of all unique patients 

discharged from the eligible hospital or CAH inpatient or emergency department (POS 21 or 23) 

actively engage with the electronic health record made accessible by the provider. An eligible 

hospital or CAH may meet the measure specified in paragraph (d)(5)(ii)(B)(1) of this section by 

having--

(i) More than 25 percent of all unique patients (or patient-authorized representatives) 

discharged from the eligible hospital or CAH inpatient or emergency department (POS 21 or 23) 

during the EHR reporting period view, download or transmit to a third party their health 

information; or 

(ii) More than 25 percent of all unique patients (or patient-authorized representatives) 

discharged from the eligible hospital or CAH inpatient or emergency department (POS 21 or 23) 

during the EHR reporting period access their health information through the use of an ONCcertified API that can be used by third-party applications or devices. 

(2) For more than 35 percent of all unique patients discharged from the eligible hospital 

or CAH inpatient or emergency department (POS 21 or 23) during the EHR reporting period, a 

secure message was sent using the electronic messaging function of CEHRT to the patient (or 

their authorized representatives), or in response to a secure message sent by the patient.

(3) Patient generated health data or data from a non-clinical setting is incorporated into 

the certified EHR technology for more than 15 percent of unique patients discharged from the 

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

reporting period. 
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(C) Exclusions under paragraph (b)(3) of this section.

(1) Any eligible hospital or CAH operating in a location that does not have 50 percent or 

more of its housing units with 4Mbps broadband availability according to the latest information 

available from the FCC on the first day of the EHR reporting period may exclude from the 

measures specified in pargraphs (d)(5)(ii)(B)(1), (B)(2), and (B)(3) of this section. 

(7) Health information exchange.

(i) EP health information exchange.

(A) Objective. The EP provides a summary of care record when transitioning or 

referring their patient to another setting of care, retrieves a summary of care record upon the first 

patient encounter with a new patient, and incorporates summary of care information from other 

providers into their EHR using the functions of certified EHR technology. 

(B) Measures. In accordance with paragraph (a)(2) of this section, an EP must attest to 

all 3 measures, but must meet the threshold for 2 of the 3 measures in paragraph (d)(6)(i)(B)(1), 

(2), and (3),in order to meet the objective. Subject to paragraph (c) of this section-- 

(1) Measure 1. For more than 50 percent of transitions of care and referrals, the EP that 

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

(i) Creates a summary of care record using CEHRT; and 

(ii) Electronically exchanges the summary of care record. 

(2) Measure 2. For more than 40 percent of transitions or referrals received and patient 

encounters in which the provider has never before encountered the patient, the EP incorporates 

into the patient's EHR an electronic summary of care document from a source other than the 

provider's EHR system. 
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(3) Measure 3. For more than 80 percent of transitions or referrals received and patient 

encounters in which the provider has never before encountered the patient, the EP performs 

clinical information reconciliation. The EP must implement clinical information reconciliation 

for the following three clinical information sets:

(i) Medication. Review of the patient's medication, including the name, dosage, 

frequency, and route of each medication.

(ii) Medication allergy. Review of the patient's known allergic medications. 

(iii) Current problem list. Review of the patient's current and active diagnoses. 

(C) Exclusions in accordance with paragraph (a)(3) of this section. An EP must be 

excluded when any of the following occur: 

(1) An EP neither transfers a patient to another setting nor refers a patient to another 

provider during the EHR reporting period must be excluded from paragraph (d)(6)(i)(B)(1) of 

this section.

(2) Any EP for whom the total of transitions or referrals recieved and patient encounters 

in which the provider has never before encountered the patient, is fewer than 100 during the 

EHR reporting period may be excluded from paragraphs (d)(6)(i)(B)(2) and (d)(6)(i)(B)(3) of 

this section.

(3) Any EP that conducts 50 percent or more of his or her patient encounters in a county 

that does not have 50 percent or more of its housing units with 4Mbps broadband availability 

according to the latest information available from the FCC on the first day of the EHR reporting 

period may exclude from the measures specified in paragraphs (d)(6)(i)(B)(1), (B)(2) and (B)(3) 

of this section.

(ii) Eligible hospitals and CAHs health information exchange.
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(A) Objective. The eligible hospital or CAH provides a summary of care record when 

transitioning or referring their patient to another setting of care, retrieves a summary of care 

record upon the first patient encounter with a their new patient, and incorporates summary of 

care information from other providers into EHR using the functions of certified EHR technology. 

(B) Measures. In accordance with paragraph (b)(2) of this section, an eligible hospital or 

CAH must attest to all three measures, but must meet the threshold for 2 of the 3 measures in 

paragraph (d)(6)(ii)(B)(1), (2), and (3). Subject to paragraph (c) of this section--

(1) Measure 1. For more than 50 percent of transitions of care and referrals, the eligible 

hospital or CAH that transitions or refers its patient to another setting of care or provider of care-

-

(i) Creates a summary of care record using CEHRT; and 

(ii) Electronically exchanges the summary of care record. 

(2) Measure 2. For more than 40 percent of transitions or referrals received and patient 

encounters in which the provider has never before encountered the patient, the eligible hospital 

or CAH incorporates into the patient's EHR an electronic summary of care document from a 

source other than the provider's EHR system. .

(3) Measure 3. For more than 80 percent of transitions or referrals received and patient 

encounters in which the provider has never before encountered the patient, the eligible hospital 

or CAH performs a clinical information reconciliation. The provider must implement clinical 

information reconciliation for the following three clinical information sets:

(i) Medication. Review of the patient's medication, including the name, dosage, 

frequency, and route of each medication.

(ii) Medication allergy. Review of the patient's known allergic medications.
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(iii) Current problem list. Review of the patient's current and active diagnoses.

(C) Exclusions in accordance with paragraph (b)(3) of this section. 

(1) Any eligible hospital or CAH for whom the total of transitions or referrals recieved 

and patient encounters in which the provider has never before encountered the patient, is fewer 

than 100 during the EHR reporting period may be excluded from paragraphs (d)(6)(i)(B)(2) and 

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

(2) Any eligible hospital or CAH operating in a location that does not have 50 percent or 

more of its housing units with 4Mbps broadband availability according to the latest information 

available from the FCC on the first day of the EHR reporting period may exclude from the 

measures specified in paragraphs (d)(6)(ii)(B)(1), (2) and (3) of this section. 

(8) Public Health and Clinical Data Registry Reporting.

(i) EP Public Health and Clinical Data Registry: Reporting objective.

(A) Objective. The EP is in active engagement with a public health agency (PHA) or 

clinical data registry (CDR) to submit electronic public health data in a meaningful way using 

certified EHR technology, except where prohibited, and in accordance with applicable law and 

practice.

(B) Measures. In order to meet the objective under paragraph (d)(8)(i)(A) of this 

section, an EP must choose from measures 1 through 5 (paragraphs (d)(8)(i)(B)(1) through 

(d)(8)(i)(B)(5) of this section) and must successfully attest to any combination of three measures. 

These measures may be met by any combination, including meeting measure specified in 

paragraph (d)(8)(i)(B)(4) or (5) of this section multiple times, in accordance with applicable law 

and practice:
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(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 non-urgent care ambulatory setting.

(3) Case reporting. The EP is in active engagement with a public health agency to 

submit case reporting of reportable conditions.

(4) Public health registry reporting. The EP is in active engagement with a public health 

agency to submit data to public health registries. 

(5) Clinical data registry reporting. The EP is in active engagement to submit data to a 

clinical data registry.

(C) Exclusions in accordance with paragraph (a)(3) of this section.

(1) Any EP meeting one or more of the following criteria may be excluded from the 

immunization registry reporting measure in paragraph (d)(8)(i)(B)(1) of this section if the EP: 

(i) Does not administer any immunizations to any of the populations for which data is 

collected by their jurisdiction's immunization registry or immunization information system 

during the EHR reporting period.

(ii) Operates in a jurisdiction for which no immunization registry or immunization 

information system is capable of accepting the specific standards required to meet the CEHRT 

definition at the start of its EHR reporting period.

(iii) Operates in a jurisdiction where no immunization registry or immunization 

information system has declared readiness to receive immunization data at the start of the EHR 

reporting period.
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(2) Any EP meeting one or more of the following criteria may be excluded from the 

syndromic surveillance reporting measure described in paragraph (d)(8)(i)(B)(2) of the section if 

the EP: 

(i) Does not treat or diagnose or directly treat any disease or condition associated with a 

syndromic surveillance system in the EP's jurisdiction.

(ii) Operates in a jurisdiction for which no public health agency is capable of receiving 

electronic syndromic surveillance data in the specific standards required to meet the CEHRT 

definition at the start of the EHR reporting period.

(iii) Operates in a jurisdiction where no public health agency has declared readiness to 

receive syndromic surveillance data at the start of the EHR reporting period.

(3) Any EP meeting one or more of the following criteria may be excluded from the case 

reporting measure at paragraph (d)(8)(i)(B)(3) of this section if the EP: 

(i) Does not treat or diagnose any reportable diseases for which data is collected by their

jurisdiction's reportable disease system during the EHR reporting period.

(ii) Operates in a jurisdiction for which no public health agency is capable of receiving 

electronic case reporting data in the specific standards required to meet the CEHRT definition at 

the start of the EHR reporting period.

(iii) Operates in a jurisdiction where no public health agency has declared readiness to 

receive electronic case reporting data at the start of the EHR reporting period. 

(4) Any EP meeting at least one of the following criteria may be excluded from the 

public health registry reporting measure specified in paragraph (d)(8)(i)(B)(4) of this section if 

the EP: 
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(i) Does not diagnose or directly treat any disease or condition associated with a public 

health registry in the EP's jurisdiction during the EHR reporting period. 

(ii) Operates in a jurisdiction for which no public health agency is capable of accepting 

electronic registry transactions in the specific standards required to meet the CEHRT definition 

at the start of the EHR reporting period.

(iii) Operates in a jurisdiction where no public health registry for which the EP is eligible 

has declared readiness to receive electronic registry transactions at the beginning of the EHR 

reporting period.

(5) Any EP meeting at least one of the following criteria may be excluded from the 

clinical data registry reporting measure specified in paragraph (d)(8)(i)(B)(5) of this section if 

the EP: 

(i) Does not diagnose or directly treat any disease or condition associated with a clinical 

data registry in their jurisdiction during the EHR reporting period; 

(ii) Operates in a jurisdiction for which no clinical data registry is capable of accepting 

electronic registry transactions in the the specific standards required to meet the CEHRT 

definition at the start of the EHR reporting period.

(iii) Operates in a jurisdiction where no clinical data registry for which the EP is eligible 

has declared readiness to receive electronic registry transactions at the beginning of the EHR 

reporting period.

(ii) Eligible hospital and CAH Public Health and Clinical Data Registry: Reporting 

objective. 

(A) Objective. The eligible hospital or CAH is in active engagement with a public 

health agency (PHA) or clinical data registry (CDR) to submit electronic public health data in a 
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meaningful way using certified EHR technology, except where prohibited, and in accordance 

with applicable law and practice.

(B) Measures. In order to meet the objective under paragraph (d)(8)(ii)(A) of this 

section, an eligible hospital or CAH must choose from measures 1 through 6 (as described in 

paragraphs (d)(8)(ii)(B)(1) through (d)(8)(ii)(B)(6) of this section) and must successfully attest to 

any combination of four measures. These measures may be met by any combination, including 

meeting the measure specified in paragraph (d)(8)(ii)(B)(4) or (5) of this section multiple times, 

in accordance with applicable law and practice:

(1) Immunization registry reporting. The eligible hospital or CAH is in active 

engagement with a public health agency to submit immunization data and receive immunization 

forecasts and histories from the public health immunization registry/immunization information 

system (IIS). 

(2) Syndromic surveillance reporting. The eligible hospital or CAH is in active 

engagement with a public health agency to submit syndromic surveillance data from an 

emergency or urgent care department (POS 23).

(3) Case reporting. The eligible hospital or CAH is in active engagement with a public 

health agency to submit case reporting of reportable conditions.

(4) Public health registry reporting. The eligible hospital or CAH is in active 

engagement with a public health agency to submit data to public health registries. 

(5) Clinical data registry reporting. The eligible hospital or CAH is in active 

engagement to submit data to a clinical data registry.

(6) Electronic reportable laboratory result reporting. The eligible hospital or CAH is in 

active engagement with a public health agency to submit electronic reportable laboratory results. 
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(C) Exclusions in accordance with paragraph (b)(3) of this section.

(1) Any eligible hospital or CAH meeting one or more of the following criteria may be 

excluded from to the immunization registry reporting measure specified in paragraph 

(d)(8)(ii)(B)(1) of this section if the eligible hospital or CAH: 

(i) Does not administer any immunizations to any of the populations for which data is 

collected by its jurisdiction's immunization registry or immunization information system during 

the EHR reporting period.

(ii) Operates in a jurisdiction for which no immunization registry or immunization 

information system is capable of accepting the specific standards required to meet the CEHRT 

definition at the start of the EHR reporting period.

(iii) Operates in a jurisdiction where no immunization registry or immunization 

information system has declared readiness to receive immunization data at the start of the EHR 

reporting period.

(2) Any eligible hospital or CAH meeting one or more of the following criteria may be 

excluded from the syndromic surveillance reporting measure specified in paragraph 

(d)(8)(ii)(B)(2) of this section if the eligible hospital or CAH: 

(i) Does not have an emergency or urgent care department. 

(ii) Operates in a jurisdiction for which no public health agency is capable of receiving 

electronic syndromic surveillance data in the specific standards required to meet the CEHRT 

definition at the start of the EHR reporting period.

(iii) Operates in a jurisdiction where no public health agency has declared readiness to 

receive syndromic surveillance data at the start of the EHR reporting period.
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(3) Any eligible hospital or CAH meeting one or more of the following criteria may be 

excluded from the case reporting measure specified in paragraph (d)(8)(ii)(B)(3) of this section if 

the eligible hospital or CAH: 

(i) Does not treat or diagnose any reportable diseases for which data is collected by their 

jurisdiction's reportable disease system during the EHR reporting period.

(ii) Operates in a jurisdiction for which no public health agency is capable of receiving 

electronic case reporting data in the specific standards required to meet the CEHRT definition at 

the start of their EHR reporting period.

(iii) Operates in a jurisdiction where no public health agency has declared readiness to 

receive electronic case reporting data at the start of the EHR reporting period.

(4) Any eligible hospital or CAH meeting at least one of the following criteria may be 

excluded from the public health registry reporting measure specified in paragraph (d)(8)(ii)(B)(4) 

of this section if the eligible hospital or CAH: 

(i) Does not diagnose or directly treat any disease or condition associated with a public 

health registry in its jurisdiction during the EHR reporting period.

(ii) Operates in a jurisdiction for which no public health agency is capable of accepting 

electronic registry transactions in the specific standards required to meet the CEHRT definition 

at the start of the EHR reporting period.

(iii) Operates in a jurisdiction where no public health registry for which the eligible 

hospital or CAH is eligible has declared readiness to receive electronic registry transactions at 

the beginning of the EHR reporting period. 
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(5) Any eligible hospital or CAH meeting at least one of the following criteria may be 

excluded from the clinical data registry reporting measure specified in paragraph (d)(8)(ii)(B)(5) 

of this section if the eligible hospital or CAH: 

(i) Does not diagnose or directly treat any disease or condition associated with a clinical 

data registry in their jurisdiction during the EHR reporting period.

(ii) Operates in a jurisdiction for which no clinical data registry is capable of accepting 

electronic registry transactions in the specific standards required to meet the CEHRT definition 

at the start of the EHR reporting period.

(iii) Operates in a jurisdiction where no clinical data registry for which the eligible 

hospital or CAH is eligible has declared readiness to receive electronic registry transactions at 

the beginning of the EHR reporting period.

(6) Any eligible hospital or CAH meeting one or more of the following criteria may be 

excluded from the electronic reportable laboratory result reporting measure specified in 

paragraph (d)(8)(ii)(B)(6) of this section if the eligible hospital or CAH: 

(i) Does not perform or order laboratory tests that are reportable in its jurisdiction during 

the EHR reporting period.

(ii) Operates in a jurisdiction for which no public health agency that is capable of 

accepting the specific ELR standards required to meet the CEHRT definition at the start of the

EHR reporting period.

(iii) Operates in a jurisdiction where no public health agency has declared readiness to 

receive electronic reportable laboratory results at the start of the EHR reporting period. 

5. Section 495.8 is amended as follows:

A. In paragraph (a) introductory text, by removing the cross-reference "under §495.6 of
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this subpart" and adding in its place the cross-reference "under §495.6 or §495.7". 

B. In paragraph (a)(1)(i)(B), by removing the cross-reference "under §495.6(d) and 

§495.6(e) of this subpart" and adding in its place the cross-reference "under §495.6 or §495.7".

C. In paragraph (a)(1)(iii), by removing the cross-reference "in §495.6 and §495.8 of this 

subpart" and adding in its place the cross-reference "in §495.6 or §495.7 and §495.8".

D. In paragraph (a)(2)(i)(B), by removing the cross-reference "under §495.6" and adding 

in its place the cross-reference "under §495.6 or §495.7".

E. Adding paragraph (a)(2)(i)(E).

F. In paragraph (a)(2)(iv), by removing the cross-reference "in §495.6 and §495.8 of this 

subpart" and adding in its place the cross-reference "in §495.6 or §495.7 and §495.8".

G. In paragraph (b)(1)(i)(B), by removing the cross-reference " under §495.6(f) and 

§495.6(g) " and adding in its place the cross-reference "under §495.6 or §495.7".

H. Redesignating paragraph (b)(1)(iv) and paragraph (b)(1)(iii).

I. In newly redesginated paragraph (b)(1)(iii), by removing the cross-reference "in 

§495.6 and §495.8 of this subpart" and adding in its place the cross-reference "in §495.6 or 

§495.7 and §495.8".

J. In paragraph (b)(2)(i)(B), by removing the cross-reference "under §495.6" and adding 

in its place the cross-reference "under §495.6 or §495.7".

K. Adding paragraph (b)(2)(i)(E).

The additions read as follows: 

§495.8 Demonstration of meaningful use criteria.

(a) * * *

(2) * * *
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(i) * * *

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

(1) Stage 1 objectives and measures outlined at § 495.6 if the EP has never before 

demonstrated meaningful use, or if the EP previously demonstrated meaningful use for the first 

time in 2015 or 2016.

(2) Stage 2 objectives and measures outlined at § 495.6 if the EP previously 

demonstrated meaningful use for any year prior to 2017. 

(3) Stage 3 objectives and measures outlined at § 495.7 if the EP has never before 

demonstrated meaningful use or if the EP has demonstrated meaningful use for any year prior to 

2017. 

* * * * *

(b) * * *

(2) * * *

(i) * * *

(E) For 2017 only, an eligible hospital or CAH may attest to the following:

(1) Stage 1 objectives and measures outlined at § 495.6 if the eligible hospital or CAH 

hase never before demonstrated meaningful use, or if the eligible hospital or CAH previously 

demonstrated meaningful use for the first time in 2015 or 2016.

(2) Stage 2 objectives and measures outlined at § 495.6 if the eligible hospital or CAH 

previously demonstrated meaningful use for any year prior to 2017.

(3) Stage 3 objectives and measures outlined at § 495.7 if the eligible hospital or CAH 

has never before demonstrated meaningful use or if the eligible hospital or CAH has 

demonstrated meaningful use for any year prior to 2017. 
CMS-3310-P 297

* * * * *

6. Section 495.316 is amended by revising paragraph (c) introductory text and adding 

paragraphs (d)(2)(iii), (f), (g), and (h) to read as follows:

§495.316 State monitoring and reporting regarding activities required to receive an 

incentive payment

* * * * *

(c) Subject to § 495.332 and § 495.352, the State is required to submit to CMS annual 

reports, in the manner prescribed by CMS, on the following: 

* * * * *

(d) * * *

(2) * * *

(iii) Subject to § 495.332, the State may propose a revised definition for Stage 3 of 

meaningful use of certified EHR technology, subject to CMS prior approval, but only with 

respect to the public health and clinical data registry reporting objective described in 

§ 495.7(d)(8).

* * * * *

(f) Each State must submit to CMS the annual report described in paragraph (c) of this 

section within 45 days of the end of the second quarter of the Federal fiscal year.

(g) The State must, on a quarterly basis and in the manner prescribed by CMS, submit a 

report(s) on the following:

(1) The State and payment year to which the quarterly report pertains. 

(2) Subject to paragraph (h)(2) of this section, provider-level attestation data for each EP 

and eligible hospital that attests to demonstrating meaningful use for each payment year 
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beginning with 2013.

(h)(1) Subject to paragraph (h)(2) of this section, the quarterly report described in 

paragraph (g) of this section must include the following for each EP and eligible hospital: 

(i) The payment year number.

(ii) The provider's National Provider Identifier or CCN, as appropriate.

(iii) Attestation submission date.

(iv) The state qualification.

(v) The state qualification date, which is the beginning date of the provider's EHR 

reporting period for which it demonstrated meaningful use.

(vi) The State disqualification, if applicable.

(vii) The State disqualification date, which is the beginning date of the provider's EHR 

reporting period to which the provider attested but for which it did not demonstrate meaningful 

use, if applicable.

(2) The quarterly report described in paragraph (g) of this section is not required to 

include information on EPs who are eligible for the Medicaid EHR incentive program on the 

basis of being a nurse practitioner, certified nurse-midwife or physician assistant.

7. Section 495.352 is revised to read as follows: 

§ 495.352 Reporting requirements.

(a) Each State must submit to HHS on a quarterly basis a progress report, in the manner 

prescribed by HHS, documenting specific implementation and oversight activities performed 

during the quarter, including progress in implementing the State's approved Medicaid HIT plan.

(b) The quarterly progress reports must include, but need not be limited to providing, 

updates on the following: 
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(1) State system implementation dates.

(2) Provider outreach.

(3) Auditing.

(4) State-specific State Medicaid HIT Plan tasks. 

(5) State staffing levels and changes.

(6) The number and type of providers that qualified for an incentive payment on the 

basis of having adopted, implemented or upgraded certified EHR technology and the amounts of 

incentive payments. 

(7) The number and type of providers that qualified for an incentive payment on the 

basis of having demonstrated that they are meaningful users of certified EHR technology and the 

amounts of incentive payments.
CMS-3310-P

Dated: March 10, 2015.

 __________________________________

Andrew M. Slavitt,

Acting Administrator,

Centers for Medicare & Medicaid Services.

Approved: March 18, 2015.

 __________________________________

Sylvia M. Burwell,

Secretary, 

Department of Health and Human Services.

BILLING CODE 4120-01-P
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[FR Doc. 2015-06685 Filed: 3/20/2015 03:00 pm; Publication Date: 3/30/2015]