29732 Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Proposed Rules 

containing the 2-cyclohexen-1-one 

moiety (calculated as the herbicide), in 

or on the following commodities are 

removed, including: Blueberry at 4.0 

ppm; Borage, seed at 6.0 ppm; 

Caneberry subgroup 13A at 5.0 ppm; 

Canola, seed at 35.0 ppm; Cotton, 

undelinted seed at 5.0 ppm; Crambe, 

seed at 35.0 ppm; Cranberry at 2.5 ppm; 

Cuphea, seed at 35.0 ppm; Echium, seed 

at 35.0 ppm; Flax, seed at 5.0 ppm; 

Fruit, citrus, group 10 at 0.5 ppm; Fruit, 

pome, group 11 at 0.2 ppm; Gold of 

pleasure, seed at 35.0 ppm; Grape at 1.0 

ppm; Hare’s ear mustard, seed at 35.0 

ppm; Juneberry at 5.0 ppm; Lesquerella, 

seed at 35.0 ppm; Lingonberry at 5.0 

ppm; Lunaria, seed at 35.0 ppm; 

Meadowfoam, seed at 35.0 ppm; 

Milkweed, seed at 35.0 ppm; Mustard, 

seed at 35.0 ppm; Oil radish, seed at 

35.0 ppm; Poppy, seed at 35.0 ppm; 

Rapeseed, seed at 35.0 ppm; Salal at 5.0 

ppm; Sesame, seed at 35.0 ppm; 

Sunflower, seed at 7.0 ppm; Sweet 

rocket, seed at 35.0 ppm; Vegetable, 

bulb, group 3 at 1.0 ppm; and Vegetable, 

fruiting, group 8 at 4.0 ppm, upon 

establishment of the proposed 

tolerances listed in 4. under ‘‘New 

Tolerance’’. 

2. PP 4E8244. (EPA–HQ–OPP–2014– 

0230). Interregional Research Project 

Number 4 (IR–4), 500 College Road East, 

Suite 201 W, Princeton, NJ 08540, 

proposing, pursuant to section 408(d) of 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), 21 U.S.C. 346a(d), to 

amend 40 CFR 180.617 by removing 

tolerances for residues of the fungicide 

metconazole, 5-[(4-chlorophenyl)- 

methyl]-2, 2-dimethyl-1-(1H-1,2,4- 

triazol-1-ylmethyl) cyclopentanol, 

measured as the sum of cis- and transisomers in or on the following raw 

agricultural commodities: Canola seed 

at 0.04 ppm; Fruit, stone, group 12 at 0.2 

ppm; Pistachio at 0.04 ppm; and Nut, 

Tree, Group 14 at 0.04 ppm. Upon 

establishment of the proposed 

tolerances listed in 5. under ‘‘New 

Tolerance’’, these previously established 

tolerances will be superseded by 

inclusion in crop group or subgroup 

tolerances established by this action. 

3. PP 3F8191. (EPA–HQ–OPP–2014– 

0225). Valent USA Corporation, 1101 

14th Street, NW., Suite 1050, 

Washington, DC 20005, requests to 

amend the tolerances in 40 CFR 180.627 

for residues of the fungicide 

fluopicolide, [2,6-dichloro-N-[[3-chloro5-(trifluoromethyl)-2- 

pyridinyl]methyl]benzamide], including 

its metabolites and degradates, in or on 

Vegetable, tuberous and corm subgroup 

1C from 0.02 ppm to 0.3 ppm; and 

Potato, processed waste from 0.05 ppm 

to 0.3 ppm. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

fluopicolide [2,6-dichloro-N-[[3-chloro5-(trifluoromethyl)-2- 

pyridinyl]methyl]benzamide] in or on 

the commodity. The Valent method RM43C-1 by LC/MS/MS is used to measure 

and evaluate the chemical fluopicolide. 

4. PP 3F8214. (EPA–HQ–OPP–2014– 

0210). FMC Corporation, 1735 Market 

Street, Philadelphia, PA 19103, requests 

to amend the tolerances in 40 CFR 

180.418 for the residues of the 

insecticide zeta-cypermethrin, in or on 

Alfalfa, forage from 5.0 ppm to 15.0 

ppm; and Alfalfa, hay from 15.0 ppm to 

30.0 ppm. There is a practical analytical 

method (gas chromatography with 

Electron Capture Detection) (GC/ECD) 

for detecting and measuring levels of 

cypermethrin and zeta-cypermethrin in 

or on food with a limit of detection 

(LOD) that allows monitoring of food 

with residues at or above the levels set 

in these tolerances. 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Agricultural commodities, Feed 

additives, Food additives, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 15, 2014. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

[FR Doc. 2014–11904 Filed 5–22–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 495 

[CMS–0052–P] 

RIN 0938–AS30 

Office of the Secretary 

45 CFR Part 170 

RIN 0991–AB97 

Medicare and Medicaid Programs; 

Modifications to the Medicare and 

Medicaid Electronic Health Record 

Incentive Programs for 2014; and 

Health Information Technology: 

Revisions to the Certified EHR 

Technology Definition 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), and Office of 

the National Coordinator for Health 

Information Technology (ONC), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

change the meaningful use stage 

timeline and the definition of certified 

electronic health record technology 

(CEHRT). It would also change the 

requirements for the reporting of 

clinical quality measures for 2014. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on July 21, 2014. 

ADDRESSES: In commenting, please refer 

to file code CMS–0052–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–0052–P, P.O. Box 8013, Baltimore, 

MD 21244–1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–0052–P, Mail 

Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to the 

following addresses prior to the close of 

the comment period: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 


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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. 

Elisabeth Myers, (410) 786–4751. 

Steven Posnack, (202) 690–7151. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http://

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

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

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

A. Statutory Basis for the Medicare and 

Medicaid EHR Incentive Programs 

The American Recovery and 

Reinvestment Act of 2009 (ARRA) (Pub. 

L. 111–5) amended Titles XVIII and XIX 

of the Social Security Act (the Act) to 

authorize incentive payments to eligible 

professionals (EPs), eligible hospitals, 

critical access hospitals (CAHs), and 

Medicare Advantage (MA) organizations 

to promote the adoption and meaningful 

use of certified electronic health record 

(EHR) technology. Sections 1848(o), 

1853(l) and (m), 1886(n), and 1814(l) of 

the Act provide the statutory basis for 

the Medicare incentive payments made 

to meaningful EHR users. These 

statutory provisions govern EPs, MA 

organizations (for certain qualifying EPs 

and hospitals that meaningfully use 

certified EHR technology (CEHRT), 

subsection (d) hospitals, and CAHs, 

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

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

the Act also establish downward 

payment adjustments, beginning with 

calendar or fiscal year 2015, for EPs, MA 

organizations, subsection (d) hospitals, 

and CAHs that are not meaningful users 

of CEHRT for certain associated 

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

and 1903(t) of the Act provide the 

statutory basis for Medicaid incentive 

payments. 

B. Considerations in Defining 

Meaningful Use and CEHRT 

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

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

identified the broad goal of expanding 

the use of EHRs through the concept of 

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

the Act also requires that Medicaid 

providers adopt, implement, upgrade, or 

meaningfully use CEHRT if they are to 

receive incentives under Title XIX of the 

Act. CEHRT used in a meaningful way 

is one piece of the broader health 

information technology (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. 

Certified EHR technology is defined 

for the Medicare and Medicaid EHR 

Incentive Programs at 42 CFR 495.4, 

which references the Office of the 

National Coordinator for Health 

Information Technology’s (ONC) 

definition of CEHRT under 45 CFR 

170.102. For Stages 1 and 2 of 

meaningful use, 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. The 

definition of CEHRT under 45 CFR 

170.102 requires, beginning with 

Federal fiscal year (FY) and calendar 

year (CY) 2014, EHR technology 

certified to the 2014 Edition EHR 

certification criteria. Therefore, all EPs, 

eligible hospitals, and CAHs must use 

2014 Edition CEHRT to meet 

meaningful use under the Medicare and 

Medicaid EHR Incentive Programs 

beginning with FY 2014 and CY 2014. 

On September 4, 2012, we published 

in the Federal Register (77 FR 53968 

through 54162) a final rule titled 

‘‘Medicare and Medicaid Programs; 

Electronic Health Record Incentive 

Program—Stage 2,’’ that established, 

among other final policies, the timeline 

for the stages of meaningful use through 

2021 and the EHR reporting periods in 

2014, as shown in Table 1 (77 FR 53973 

through 53975). 

TABLE 1—STAGE OF MEANINGFUL USE CRITERIA BY FIRST PAYMENT YEAR

First payment year 

Stage of meaningful use 

2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 

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

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

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

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

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

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

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

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

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

EPs, eligible hospitals, and CAHs that 

attest to meaningful use for 2014 for 

their first year of Stage 2 or their second 

year of Stage 1 have a 3-month quarter 

EHR reporting period in CY 2014 (EPs) 

or FY 2014 (eligible hospitals and 

CAHs). For the Medicaid incentive 

payments for meaningful use, EPs have 

an EHR reporting period of any 

continuous 90-day period in CY 2014 as 

defined by the State Medicaid program, 

or, if the State so chooses, any 3-month 


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CY quarter in 2014. EPs, eligible 

hospitals, and CAHs that demonstrate 

meaningful use for the first time in 2014 

have an EHR reporting period of any 

continuous 90-day period in CY 2014 or 

FY 2014, respectively. 

II. Provisions of the Proposed 

Regulations 

A. Proposed Changes to Meaningful Use 

Stage Timeline and the Use of CEHRT 

1. Reporting in 2014 

We are revisiting some of the 

requirements for the Medicare and 

Medicaid EHR Incentive Programs for 

2014. Many EHR vendors have 

indicated, through letters to CMS, 

public forums and listening sessions, 

survey data, and information related to 

the certification and testing process, that 

the amount of time available after the 

publication of the Stage 2 final rule in 

which to make the required coding 

changes to enable their EHR products to 

be certified to the 2014 Edition of EHR 

certification criteria was much too short. 

We understand, based on information 

gained from EHR technology developers 

and ONC-Authorized Certification 

Bodies on timing, backlogs, and the 

certification case load, many EHR 

products were certified later than 

anticipated, which has impacted the 

corresponding time available to 

providers—especially hospitals—to 

effectively deploy 2014 Edition CEHRT 

and to make the necessary patient 

safety, staff training, and workflow 

investments in order to be prepared to 

demonstrate meaningful use in 2014. 

The availability of 2014 Edition CEHRT 

is further limited by the large number of 

providers needing to upgrade to 2014 

Edition CEHRT. By the end of February 

2014, over 350,000 providers had 

received an EHR incentive payment for 

adopting, implementing, or upgrading, 

or for successfully demonstrating 

meaningful use using 2011 Edition 

CEHRT. All providers need 2014 

Edition CEHRT to adopt, implement, or 

upgrade, or to successfully demonstrate 

meaningful use for Stage 1 or Stage 2 in 

2014. Through letters to CMS, public 

forums, listening sessions, and public 

comment at CMS meetings, many 

provider associations have expressed 

concern that, although 2014 Edition 

CEHRT may be available for adoption, 

there is a backlog of many months for 

the updated version to be installed and 

implemented so that providers can 

successfully attest for 2014. We also 

understand that the delay in availability 

may limit a provider’s ability to fully 

implement 2014 Edition CEHRT across 

the facility. For example, (1) a hospital 

may have different systems in multiple 

settings, which all require an update 

and integration or (2) a provider may 

have certain 2014 Edition CEHRT 

functionality that, once implemented in 

a live setting, requires software patches 

or workflow changes. 

In an effort to grant more flexibility to 

providers who have experienced 2014 

Edition CEHRT product availability 

issues that impact the ability to fully 

implement 2014 Edition CEHRT to 

attest to meaningful use using 2014 

Edition CEHRT, we are proposing the 

following changes for the Medicare and 

Medicaid EHR Incentive Programs for 

2014 for providers that are not able to 

fully implement 2014 Edition CEHRT 

for a full EHR reporting period in 2014. 

We are proposing to allow these EPs, 

eligible hospitals, and CAHs that could 

not fully implement 2014 Edition 

CEHRT for the 2014 reporting year due 

to delays in 2014 Edition CEHRT 

availability to continue to use 2011 

Edition CEHRT or a combination of 

2011 Edition and 2014 Edition CEHRT 

for the EHR reporting periods in CY 

2014 and FY 2014, respectively. These 

proposed alternatives are for providers 

that could not fully implement 2014 

Edition CEHRT to meet meaningful use 

for the duration of an EHR reporting 

period in 2014 due to delays in 2014 

Edition CEHRT availability. 

We are proposing this change for 2014 

only. We will maintain the existing 

policy that all providers must use 2014 

Edition CEHRT for the EHR reporting 

periods in CY 2015, FY 2015, and in 

subsequent years or until new 

certification requirements are adopted 

in subsequent rulemaking. 

We strongly recommend eligible 

professionals, eligible hospitals, and 

CAHs that have not yet purchased EHR 

technology to obtain 2014 Edition 

CEHRT as these providers will still need 

to use 2014 Edition CEHRT for their 

EHR reporting period in 2015 as stated 

earlier. 

In order to avoid inadvertently 

incentivizing the purchase of an 

outdated product that cannot be used to 

demonstrate meaningful use in a 

subsequent year, we are proposing that 

to qualify for an incentive payment 

under Medicaid for 2014 for adopting, 

implementing, or upgrading CEHRT, a 

provider must adopt, implement, or 

upgrade to 2014 Edition CEHRT only. A 

provider would not be able to qualify for 

a Medicaid incentive payment for 2014 

for adopting, implementing, or 

upgrading to 2011 Edition CEHRT or a 

combination of 2011 and 2014 Edition 

CEHRT. We are proposing to revise the 

definition of ‘‘Adopt, Implement or 

Upgrade’’ under 42 CFR 495.302 to 

reflect this proposal. 

The edition of certified EHR 

technology which is available to a 

provider dictates the stage and version 

of the meaningful use objectives and 

measures to which the provider will be 

able to attest. For example, 2011 Edition 

CEHRT alone does not have the 

necessary functionality required to meet 

the Stage 2 objectives and measures. In 

addition, the edition of CEHRT 

determines which clinical quality 

measures a provider can calculate and 

report because the calculations are part 

of the software programming within the 

CEHRT system. 

The three options for the use of 

CEHRT editions and the available Stage 

of meaningful use objectives and 

measures associated with each option 

are as follows: 

a. Using 2011 Edition CEHRT Only 

We are proposing that all EPs, eligible 

hospitals, and CAHs that use only 2011 

Edition CEHRT for their EHR reporting 

period in 2014 must meet the 

meaningful use objectives and 

associated measures for Stage 1 under 

42 CFR 495.6 that were applicable for 

the 2013 payment year, regardless of 

their current stage of meaningful use. 

We note that in the Stage 2 final rule (77 

FR 53975 through 53979), we finalized 

certain changes to the Stage 1 objectives 

and associated measures, and some of 

those changes were applicable 

beginning with 2013 while other 

changes were applicable beginning with 

2014. For ease of reference, we will refer 

to the Stage 1 objectives and associated 

measures under 42 CFR 495.6 that were 

applicable for 2013 as the ‘‘2013 Stage 

1 objectives and measures,’’ and we will 

refer to the Stage 1 objectives and 

associated measures under 42 CFR 495.6 

that are applicable for 2014 as the ‘‘2014 

Stage 1 objectives and measures.’’ 

Providers who choose this option must 

attest that they are unable to fully 

implement 2014 Edition CEHRT 

because of issues related to 2014 Edition 

CEHRT availability delays when they 

attest to the meaningful use objectives 

and measures. 

b. Using a Combination of 2011 and 

2014 Edition CEHRT 

We are proposing that all EPs, eligible 

hospitals, and CAHs using a 

combination of 2011 Edition CEHRT 

and 2014 Edition CEHRT for their EHR 

reporting period in 2014 may choose to 

meet the 2013 Stage 1 objectives and 

measures or the 2014 Stage 1 objectives 

and measures, or if they are scheduled 

to begin Stage 2 in 2014 under the 

timeline shown in Table 1, they may 

choose to meet the Stage 2 objectives 

and associated measures under 42 CFR 


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495.6. Providers who choose this option 

must attest that they are unable to fully 

implement 2014 Edition CEHRT 

because of issues related to 2014 Edition 

CEHRT availability delays when they 

attest to the meaningful use objectives 

and measures. 

c. Using 2014 Edition CEHRT for 2014 

Stage 1 Objectives and Measures in 2014 

for Providers Scheduled To Begin Stage 

2 

A provider’s ability to fully 

implement all of the functionality of 

2014 Edition CEHRT may be limited by 

the availability and timing of product 

installation, deployment of new 

processes and workflows, and employee 

training. This effect is compounded for 

providers in Stage 2 as some providers 

may not be able to fully implement all 

of the functions included in 2014 

Edition CEHRT that are necessary to 

meet the Stage 2 objectives and 

measures in time to complete their EHR 

reporting period in 2014. Therefore, 

under our proposal, providers who are 

scheduled to begin Stage 2 for the 2014 

EHR reporting period but are unable to 

fully implement all the functions of 

their 2014 Edition CEHRT required for 

Stage 2 objectives and measures due to 

delays in 2014 Edition CEHRT 

availability would have the option of 

using 2014 Edition CEHRT to attest to 

the 2014 Stage 1 objectives and 

measures for the 2014 EHR reporting 

period. Providers who are scheduled to 

begin Stage 2 in 2014 who choose this 

option must attest that they are unable 

to fully implement 2014 Edition CEHRT 

because of issues related to 2014 Edition 

CEHRT availability delays when they 

attest to the meaningful use objectives 

and measures. 

The EHR reporting periods in 2014 

already have been established, and we 

are not proposing any changes. Under 

the current timeline shown in Table 1, 

providers that first demonstrated 

meaningful use Stage 1 in 2011 or 2012 

are required to begin Stage 2 in 2014. 

We are proposing that the flexibility 

regarding use of the various editions of 

CEHRT as outlined earlier would apply 

only to the EHR reporting periods in 

2014 for the EHR Incentive Program. 

Providers that were scheduled to begin 

Stage 2 in 2014 that instead meet the 

Stage 1 criteria in 2014 will be required 

to begin Stage 2 in 2015 as noted in 

Table 3. In 2015, all providers, except 

those in their first year of demonstrating 

meaningful use, are required to have a 

full year EHR reporting period. In 

addition, in 2015, all providers are 

required to have 2014 Edition CEHRT in 

order to successfully demonstrate 

meaningful use. 

TABLE 2—PROPOSED CEHRT SYSTEMS AVAILABLE FOR USE IN 2014 

If you were scheduled to 

demonstrate: 

You would be able to attest for Meaningful Use: 

Using 2011 Edition CEHRT to do: Using 2011 & 2014 Edition CEHRT 

to do: Using 2014 Edition CEHRT to do: 

Stage 1 in 2014 ................. 2013 Stage 1 objectives and measures *.2013 Stage 1 objectives and measures *.2014 Stage 1 objectives and measures 

-OR2014 Stage 1 objectives and measures *.

Stage 2 in 2014 ................. 2013 Stage 1 objectives and measures *.2013 Stage 1 objectives and measures *.2014 Stage 1 objectives and measures * 

-OR- -OR2014 Stage 1 objectives and measures *.

Stage 2 objectives and measures * 

-ORStage 2 objectives and measures *.

* Only providers that could not fully implement 2014 Edition CEHRT for the reporting period in 2014 due to delays in 2014 Edition CEHRT 

availability. 

The following are example scenarios 

under our proposal. 

Example A: An EP initiated 

participation in the Medicare EHR 

Incentive Program in 2011. The EP 

successfully demonstrated meaningful 

use and received incentive payments for 

2011, 2012, and 2013. Based on the 

timeline in the Stage 2 final rule, the EP 

is required to use 2014 Edition CEHRT 

and demonstrate Stage 2 of meaningful 

use in 2014. Under our proposal, this EP 

who is scheduled to begin Stage 2 in 

2014 would have the following options: 

• Attest to the Stage 2 objectives and 

measures of meaningful use using 2014 

Edition CEHRT in 2014 as scheduled. 

• Attest to the Stage 2 objectives and 

measures of meaningful use using a 

combination of 2011 and 2014 Edition 

CEHRT in 2014 if they are unable to 

fully implement 2014 Edition CEHRT 

due to delays in 2014 Edition CEHRT 

availability. 

• Attest to the 2014 Stage 1 objectives 

and measures using 2014 Edition 

CEHRT or a combination of 2011 and 

2014 Edition CEHRT in 2014 if they are 

unable to fully implement 2014 Edition 

CEHRT due to delays in 2014 Edition 

CEHRT availability. 

• Attest to the 2013 Stage 1 objectives 

and measures using 2011 Edition 

CEHRT or a combination of 2011 and 

2014 Edition CEHRT in 2014 if they are 

unable to fully implement 2014 Edition 

CEHRT due to delays in 2014 Edition 

CEHRT availability. Clinical quality 

measures must be submitted through 

attestation if attesting to the 2013 Stage 

1 objectives and measures as discussed 

below in section B of this proposal. 

Example B: An EP initiated 

participation in the Medicare EHR 

Incentive Program in 2013. The EP 

successfully demonstrated meaningful 

use and received an incentive payment 

for 2013. Based on the timeline in the 

Stage 2 final rule, the EP is required to 

use 2014 Edition CEHRT and 

demonstrate Stage 1 of meaningful use 

in 2014. Under our proposal, this EP 

would have one of the following 

options: 

• Attest using 2014 Edition CEHRT to 

the 2014 Stage 1 objectives and 

measures of meaningful use in 2014 as 

scheduled. 

• Attest using a combination of 2011 

and 2014 Edition CEHRT and meet the 

2014 Stage 1 objectives and measures of 

meaningful use in 2014 if they are 

unable to fully implement 2014 Edition 

CEHRT due to delays in 2014 Edition 

CEHRT availability. 

• Attest using 2011 Edition CEHRT or 

a combination of 2011 and 2014 Edition 

CEHRT and meet the 2013 Stage 1 


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objectives and measures of meaningful 

use in 2014 if they are unable to fully 

implement 2014 Edition CEHRT due to 

delays in 2014 Edition CEHRT 

availability. Clinical quality measures 

must be submitted through attestation if 

attesting to the 2013 Stage 1 objectives 

and measures as discussed in section 

II.B. of this proposed rule. 

2. Extension of Stage 2 

Under the current timeline shown in 

Table 1, an EP, eligible hospital or CAH 

that first became a meaningful user in 

2011 or 2012 would be required to begin 

Stage 3 on January 1, 2016 (the first day 

of CY 2016 for EPs) or October 1, 2015 

(the first day of FY 2016 for eligible 

hospitals or CAHs), respectively. 

However, because we intend to analyze 

the meaningful use Stage 2 data to 

inform our development of the criteria 

for Stage 3 of meaningful use, we are 

proposing a 1-year extension of Stage 2 

for those providers as is reflected in 

Table 3. We are proposing that Stage 3 

would begin in CY 2017 for EPs and FY 

2017 for eligible hospitals and CAHs 

that first became meaningful users in 

2011 or 2012. The goal of this proposed 

change is two-fold: First, to allow CMS 

and ONC to focus efforts on the 

successful implementation of the 

enhanced patient engagement, 

interoperability, and health information 

exchange requirements in Stage 2; and 

second, to utilize data from Stage 2 

participation to inform policy decisions 

for Stage 3. 

This proposed change would allow 

EPs, eligible hospitals, and CAHs that 

first became meaningful users in 2011 or 

2012 to begin Stage 3 on January 1, 2017 

(EPs) and October 1, 2016 (eligible 

hospitals and CAHs). We will maintain 

the existing timeline for providers that 

first became meaningful users in 2013 

and for those that begin in 2014 and 

subsequent years or until new 

certification requirements are adopted 

in subsequent rulemaking, as shown in 

Table 3. 

TABLE 3—PROPOSED 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 State option) for Medicaid 

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

We invite public comment on our 

proposals. 

B. Clinical Quality Measure Submission 

in 2014 

In 2014, as part of the definition of 

‘‘meaningful EHR user’’ under 42 CFR 

495.4, all providers are required to 

select and report on clinical quality 

measures (CQMs) from the relevant sets 

adopted in the Stage 2 final rule (77 FR 

54069 through 54075, and 77 FR 54081 

through 54089 and further specified as 

noted in the December 7, 2012 interim 

final rule with comment period (77 FR 

72985) and published on the CMS 

eCQM Library [http://cms.gov/

Regulations-and-Guidance/Legislation/

EHRIncentivePrograms/eCQM_

Library.html], regardless of their stage of 

meaningful use or year of participation 

in the EHR Incentive Program. We are 

proposing the following changes for 

reporting on clinical quality measures in 

2014 for EPs, eligible hospitals, and 

CAHs for the Medicare and Medicaid 

EHR Incentive Programs. The method of 

CQM submission under this proposal 

would depend on the edition of CEHRT 

a provider uses to record, calculate, and 

report its clinical quality measures for 

the selected EHR reporting period in 

2014. 

Due to limitations in the Registration 

and Attestation System for the EHR 

Incentive Program and other CMS data 

systems, the reporting options and 

methods for CQMs for 2014 would 

depend upon the edition of CEHRT that 

a provider uses for its EHR reporting 

period in 2014. If a provider elects to 

use only 2011 Edition CEHRT for its 

EHR reporting period in 2014, the 

provider would be required to report 

CQMs by attestation as follows: 

• EPs would report from the set of 44 

measures and according to the reporting 

criteria finalized in the Stage 1 final rule 

(75 FR 44386 through 44411)— 

++ Three core/alternate core; 

++ Three additional measures; and 

++ The reporting period would be any 

continuous 90 days within CY 2014 

for EPs that are demonstrating 

meaningful use for the first time or a 

3-month CY quarter for EPs that have 

previously demonstrated meaningful 

use. 

• Eligible hospitals and CAHs would 

report all 15 measures finalized in the 

Stage 1 final rule (75 FR 44411 through 

44422). 

• The reporting period would be any 

continuous 90 days within FY 2014 for 

hospitals that are demonstrating 

meaningful use for the first time or a 3- 

month FY quarter for hospitals that have 

previously demonstrated meaningful 

use. 

If a provider elects to use a 

combination of 2011 Edition and 2014 

Edition CEHRT and chooses to attest to 

the 2013 Stage 1 objectives and 

measures for its EHR reporting period in 

2014, the provider would be required to 

report CQMs by attestation using the 

same measure sets and reporting criteria 

outlined earlier for providers who elect 

to use only 2011 Edition CEHRT for 

their EHR reporting periods in 2014. 

Because of the differences in how CQMs 

are calculated and tested between the 

2011 and the 2014 Editions of CEHRT, 

we are further proposing that a provider 

may attest to data for the CQMs derived 

exclusively from the 2011 Edition 

CEHRT for the portion of the reporting 

period in which 2011 Edition CEHRT 

was in place. 

If a provider elects to use a 

combination of 2011 Edition and 2014 

Edition CEHRT and chooses to attest to 

the 2014 Stage 1 objectives and 

measures or the Stage 2 objectives and 

measures, the provider would be 

required to submit CQMs in accordance 

with the requirements and policies 

established for clinical quality measure 

reporting for 2014 in the Stage 2 final 

rule and subsequent rulemakings. For 

further explanation, we refer readers to 


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Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Proposed Rules 29737 

the following: For EPs—77 FR 54049 

through 54089, 77 FR 72985 through 

72991, 78 FR 74753 through 74757; and 

for eligible hospitals and CAHs—77 FR 

54049 through 54089, 77 FR 72985 

through 72991, 78 FR 50903 through 

50906. We are also proposing that a 

provider must submit CQMs in 

accordance with the requirements and 

policies established for 2014 in those 

rulemakings if the provider elects to use 

only 2014 Edition CEHRT for the entire 

duration of its EHR reporting period in 

2014, regardless of the stage of 

meaningful use that the provider 

chooses to meet. 

For the Medicaid EHR Incentive 

Program, the method of reporting CQMs 

for EPs and eligible hospitals will 

continue to be at the state’s discretion 

subject to our prior approval, as 

established in the Stage 2 final rule (77 

FR 54075 through 54078, and 54087 

through 54089). 

We invite public comment on our 

proposal. 

C. Revision to the CEHRT Definition for 

Additional Flexibility in 2014 

To support the CMS proposals to 

provide additional flexibility in the 

Medicare and Medicaid EHR Incentive 

Programs during 2014, ONC is 

proposing to make a minor, but 

necessary, corresponding revision to the 

CEHRT definition at 45 CFR 170.102. 

ONC is proposing to revise the 

CEHRT definition to change certain 

Federal fiscal year (FY)/calendar year 

(CY) cutoffs in paragraphs (1) and (2) of 

the CEHRT definition under 45 CFR 

170.102. These FY/CY cutoffs were 

finalized in ONC’s 2014 Edition final 

rule (77 FR 54257 through 54260). The 

policy in paragraph (1) of the definition 

applies to any fiscal year/calendar year 

up to and including 2013. The policy in 

paragraph (2) of the definition applies to 

FY 2014/CY 2014 and all subsequent 

years. 

Paragraph (1) sets forth policy that 

permitted the use of 2011 Edition 

certified Complete EHRs and EHR 

Modules, a combination of 2011 and 

2014 Edition certified Complete EHRs 

and EHR Modules, and 2014 Edition 

certified Complete EHRs and EHR 

Modules to be used to meet the CEHRT 

definition through the end of FY 2013/ 

CY 2013. However, paragraph (2) 

establishes policy that, starting with FY 

2014/CY 2014, only the use of 2014 

Edition certified Complete EHRs and 

EHR Modules could be used to meet the 

CEHRT definition. 

The following specific proposed 

revisions to the CEHRT definition are 

necessary to support the added 

flexibility we proposed for 2014. The 

effect of these proposed revisions would 

be to allow EPs, eligible hospitals, and 

CAHs to use either 2011 Edition or a 

combination of 2011 and 2014 Edition 

certified Complete EHRs and EHR 

Modules to meet the CEHRT definition 

and to demonstrate meaningful use 

Stage 1 for 2014. 

Specifically, ONC is proposing to 

modify the CEHRT definition at 45 CFR 

170.102 to replace the following 

• ‘‘2013’’ with ‘‘2014’’ in the first 

sentence of paragraph (1). 

• ‘‘FY and CY 2014’’ with ‘‘FY and 

CY 2015’’ in paragraph (1)(i) and (1)(iii). 

• ‘‘2014’’ with ‘‘2015’’ in the first 

sentence of paragraph (2). 

Overall, this proposed revision would 

make the first day of FY 2015 (for 

eligible hospitals and CAHs) and CY 

2015 (for eligible professionals) the new 

required start date for exclusive use of 

2014 Edition certified Complete EHRs 

and EHR Modules to meet the CEHRT 

definition. 

We invite public comment on our 

proposals. 

III. Collection of Information 

Requirements 

This document does not impose any 

new information collection 

requirements, that is, reporting, 

recordkeeping or third-party disclosure 

requirements, as defined under the 

Paperwork Reduction Act of 1995 (5 

CFR 1320). However, it does make 

reference to the currently approved 

information collection request 

associated with the Electronic Health 

Record Incentive Program. The 

information collection requirements for 

the program are currently approved 

under OMB control number 0938–1158 

with an expiration date of April 30, 

2015. 

IV. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

V. Regulatory Impact Statement 

We have examined the impact 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 rule does not reach the economic 

threshold and thus is not considered a 

major rule. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities. For purposes of the RFA, small 

entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. Most 

hospitals and most other providers and 

suppliers are small entities, either by 

nonprofit status or by having revenues 

of less than $7.0 million to $35.5 

million in any 1 year. Individuals and 

States are not included in the definition 

of a small entity. We are not preparing 

an analysis for the RFA because we have 

determined, and the Secretary certifies, 

that this proposed rule would not have 

a significant economic impact on a 

substantial number of small entities. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may 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 for 

Medicare payment regulations and has 

fewer than 100 beds. We are not 

preparing an analysis for section 1102(b) 

of the Act because we have determined, 

and the Secretary certifies, that this 

proposed rule would not have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates require spending 

in any 1 year of $100 million in 1995 

dollars, updated annually for inflation. 

In 2014, that threshold is approximately 


sroberts on DSK5SPTVN1PROD with PROPOSALS
29738 Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Proposed Rules 

$141 million. This rule will have no 

consequential effect on State, local, or 

tribal governments or on the private 

sector. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

Since this rule does not impose any 

costs on State or local governments, the 

requirements of Executive Order 13132 

are not applicable. 

CMS is proposing, for 2014 only, that 

EPs, eligible hospitals, and CAHs would 

be able to use either 2011 Edition, 2014 

Edition or a combination of 2011 and 

2014 Edition certified Complete EHRs 

and EHR Modules to meet the CEHRT 

definition and to demonstrate 

meaningful use during 2014. 

To support the CMS proposals to 

provide added flexibility in the 

Medicare and Medicaid EHR Incentive 

Programs during 2014, ONC is 

proposing to make a minor, but 

necessary, corresponding revision to the 

CEHRT definition specified at 45 CFR 

170.102, to change certain FY/CY 

cutoffs in paragraphs (1) and (2) of the 

CEHRT definition. These FY/CY cutoffs 

were finalized in ONC’s 2014 Edition 

final rule (77 FR 54257 through 54260). 

With respect to our proposal to allow 

the flexibility to use 2011 Edition 

Certified EHR Technology, a 

combination of 2011 Edition and 2014 

Edition Certified EHR Technology, or 

solely 2014 Edition Certified EHR 

Technology in 2014, we do not believe 

that this proposal will have a significant 

impact as it merely gives providers the 

flexibility to choose to retain and use 

their 2011 Edition CEHRT, a 

combination of 2011 and 2014 Edition 

CEHRT, or 2014 Edition CEHRT in 

2014. We are making this proposal in 

response to concerns that the 

availability of 2014 Edition CEHRT is 

quite limited. We refer readers to the 

impact analyses included in the final 

rule titled ‘‘Medicare and Medicaid 

Programs; Electronic Health Record 

Incentive Program—Stage 2’’ (77 FR 

53698 through 54162). Similarly, the 

ONC proposal to revise the CEHRT 

definition merely provides additional 

flexibility in support of the CMS 

proposals and ONC does not believe 

that it will have a significant impact (see 

‘‘Health Information Technology: 

Standards, Implementation 

Specifications, and Certification Criteria 

for Electronic Health Record 

Technology, 2014 Edition; Revisions to 

the Permanent Certification Program for 

Health Information Technology’’ (77 FR 

54163 through 54292)). 

In accordance with the provisions of 

Executive Order 12866, this rule was 

reviewed by the Office of Management 

and Budget. 

List of Subjects 

42 CFR Part 495 

Administrative practice and 

procedure, Health facilities, Health 

maintenance, organizations (HMO), 

Medicare, Penalties, Privacy, Reporting 

and recordkeeping requirements. 

45 CFR Part 170 

Computer technology, Electronic 

health record, Electronic information 

system, Electronic transactions, Health, 

Health care, Health information 

technology, Health insurance, Health 

records, Hospitals, Incorporation by 

reference, Laboratories, Medicaid, 

Medicare, Privacy, Reporting and 

recordkeeping requirements, Public 

health, Security. 

For the reasons stated in the preamble 

of this proposed rule, the Centers for 

Medicare & Medicaid Services is 

proposing to amend 42 CFR Part 495 

and the Department is proposing to 

amend 45 CFR Part 170 as set forth 

below: 

Title 42—Public Health 

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 495.302 is amended by 

adding paragraph (4) to the definition of 

‘‘Adopt, implement or upgrade’’ to read 

as follows: 

§ 495.302 Definitions. 

* * * * * 

Adopt, implement or upgrade 

means— 

* * * * * 

(4) For payment year 2014, the 

references to ‘‘certified EHR 

technology’’ in paragraphs (1) through 

(3) of this definition are deemed to be 

references to paragraph (2) of the 

definition of ‘‘Certified EHR 

Technology’’ under 45 CFR 170.102 

(that is, the definition of ‘‘Certified EHR 

Technology’’ for FY and CY 2015 and 

subsequent years). 

* * * * * 

Title 45—Public Health 

PART 170—HEALTH INFORMATION 

TECHNOLOGY STANDARDS, 

IMPLEMENTATION SPECIFICATIONS, 

AND CERTIFICATION CRITERIA AND 

CERTIFICATION PROGRAMS FOR 

HEALTH INFORMATION 

TECHNOLOGY 

■ 3. The authority citation for part 170 

continues to read as follows: 

Authority: 42 U.S.C. 300jj–11; 42 U.S.C. 

300jj–14; 5 U.S.C. 552. 

§ 170.102 [Amended] 

■ 4. In § 170.102, the definition of 

‘‘Certified EHR Technology’’ is amended 

as follows: 

■ A. In paragraph (1) introductory text, 

by removing the year ‘‘2013’’ and 

adding in its place the year ‘‘2014’’. 

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

‘‘; or ’’ and adding in its place ‘‘;’’. 

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

the phrase ‘‘FY and CY 2014’’ and 

adding in its place the phrase ‘‘FY and 

CY 2015’’ and by removing the crossreference ‘‘paragraph (2);’’ and adding in 

its place the cross-reference ‘‘paragraph 

(2) of this definition’’. 

■ D. In paragraph (2), by removing the 

phrase ‘‘FY and CY 2014’’ and adding 

in its place the phrase ‘‘FY and CY 

2015’’. 

Dated: May 12, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: May 13, 2014. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2014–11944 Filed 5–20–14; 4:15 pm] 

BILLING CODE 4120–01–P 


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