Federal Register / Vol. 77, No. 236 / Friday, December 7, 2012 / Rules and Regulations 72985 

a typographical error only. EPA finds 

that this constitutes good cause under 5 

U.S.C. 553(b)(3)(B). 

IV. Do any of the statutory and 

executive order reviews apply to this 

action? 

This technical correction only revises 

the spelling of one commodity and does 

not otherwise change the original final 

rule. As a technical correction, this 

action is not subject to the statutory and 

executive order review requirements. 

For information about the statutory and 

executive order review requirements as 

they relate to the final rule, see Unit VI. 

in the Federal Register of October 17, 

2012 (77 FR 63745) (FRL–9364–9). 

V. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: November 30, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR part 180 is 

corrected as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.511, remove from the table 

in paragraph (a), the entry for ‘‘Logan’’ 

and add an entry for ‘‘Longan’’ to read 

as follows: 

§ 180.511 Buprofezin; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Longan ........................................ 0.30 

* * * * * 

* * * * * 

[FR Doc. 2012–29680 Filed 12–6–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 495 

[CMS–0046–IFC] 

RIN 0938–AR71 

Office of the Secretary 

45 CFR Part 170 

RIN 0991–AB89 

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 

AGENCY: Office of the National 

Coordinator for Health Information 

Technology (ONC) and Centers for 

Medicare & Medicaid Services (CMS), 

Department of Health and Human 

Services. 

ACTION: Interim final rule with comment 

period. 

SUMMARY: The Department of Health and 

Human Services (HHS) is issuing this 

interim final rule with comment period 

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. 

This interim final rule with comment 

period also revises the Medicare and 

Medicaid Electronic Health Record 

(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 clinical quality measure 

(CQM) reporting applicable for eligible 

hospitals and critical access hospitals 

(CAHs) beginning with FY 2013. This 

rule also provides notice of CMS’s 

intention to issue technical corrections 

to the electronic specifications for 

CQMs released on October 25, 2012. 

DATES: Effective Date: This interim final 

rule with comment period is effective 

January 7, 2013. 

The incorporation by reference of 

certain publications listed in the rule is 

approved by the Director of the Federal 

Register as of January 7, 2013. 

Comment Date: To be assured 

consideration, written or electronic 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on February 5, 2013. 

ADDRESSES: Because of staff and 

resource limitations, we cannot accept 

comments by facsimile (FAX) 

transmission. You may submit 

comments, identified by RIN 0991– 

AB89 or RIN 0938–AR71, by any of the 

following methods (please do not 

submit duplicate comments). 

• Federal eRulemaking Portal: Follow 

the instructions for submitting 

comments. Attachments should be in 

Microsoft Word, Adobe PDF, or Excel; 

however, we prefer Microsoft Word. 

http://www.regulations.gov. 

• Regular, Express, or Overnight Mail: 

Department of Health and Human 

Services, Office of the National 

Coordinator for Health Information 

Technology, Attention: Steven Posnack, 

Hubert H. Humphrey Building, Suite 

729D, 200 Independence Ave. SW., 

Washington, DC 20201. Please submit 

one original and two copies. 

• Hand Delivery or Courier: Office of 

the National Coordinator for Health 

Information Technology, Attention: 

Steven Posnack, Hubert H. Humphrey 

Building, Suite 729D, 200 Independence 

Ave. SW., Washington, DC 20201. 

Please submit one original and two 

copies. (Because access to the interior of 

the Hubert H. Humphrey Building is not 

readily available to persons without 

federal government identification, 

commenters are encouraged to leave 

their comments in the mail drop slots 

located in the main lobby of the 

building.) 

Inspection of Public Comments: All 

comments received before the close of 

the comment period will be available for 

public inspection, including any 

personally identifiable or confidential 

business information that is included in 

a comment. Please do not include 

anything in your comment submission 

that you do not wish to share with the 

general public. Such information 

includes, but is not limited to: A 

person’s social security number; date of 

birth; driver’s license number; state 

identification number or foreign country 

equivalent; passport number; financial 

account number; credit or debit card 


srobinson on DSK4SPTVN1PROD with 
72986 Federal Register / Vol. 77, No. 236 / Friday, December 7, 2012 / Rules and Regulations 

number; any personal health 

information; or any business 

information that could be considered to 

be proprietary. We will post all 

comments received before the close of 

the comment period at http:// 

www.regulations.gov. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov or U.S. Department 

of Health and Human Services, Office of 

the National Coordinator for Health 

Information Technology, Hubert H. 

Humphrey Building, Suite 729D, 200 

Independence Ave. SW., Washington, 

DC 20201 (call ahead to the contact 

listed below to arrange for inspection). 

FOR FURTHER INFORMATION CONTACT: 

Steven Posnack, Director, Federal Policy 

Division, Office of Policy and 

Planning, Office of the National 

Coordinator for Health Information 

Technology, 202–690–7151, for EHR 

technology standards and certification 

criteria issues. 

Elizabeth Holland, (410) 786–1309, or 

Robert Anthony, (410) 786–6183, for 

Medicare EHR Incentive Program 

issues. 

David Koppel, (410) 786–3255, for 

Medicaid EHR Incentive Program 

issues. 

Maria Michaels, (410) 786–2809, for 

clinical quality measures issues. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Statutory Basis 

1. Standards, Implementation 

Specifications, and Certification Criteria 

The Health Information Technology 

for Economic and Clinical Health 

(HITECH) Act, Title XIII of Division A 

and Title IV of Division B of the 

American Recovery and Reinvestment 

Act of 2009 (ARRA) (Pub. L. 111–5), was 

enacted on February 17, 2009. The 

HITECH Act amended the Public Health 

Service Act (PHSA) and created ‘‘Title 

XXX—Health Information Technology 

and Quality’’ (Title XXX) to improve 

health care quality, safety, and 

efficiency through the promotion of HIT 

and electronic health information 

exchange. 

Section 3004(b)(3) of the PHSA titled 

‘‘Subsequent Standards Activity’’ 

provides that the ‘‘Secretary shall adopt 

additional standards, implementation 

specifications, and certification criteria 

as necessary and consistent’’ with the 

schedule published by the HIT 

Standards Committee. We consider this 

provision in the broader context of the 

HITECH Act to grant the Secretary the 

authority and discretion to adopt 

standards, implementation 

specifications, and certification criteria 

that have been recommended by the HIT 

Standards Committee and endorsed by 

the National Coordinator, as well as 

other appropriate and necessary HIT 

standards, implementation 

specifications, and certification criteria. 

2. HIT Certification Programs 

Section 3001(c)(5) of the PHSA 

provides the National Coordinator with 

the authority to establish a certification 

program or programs for the voluntary 

certification of HIT. Specifically, section 

3001(c)(5)(A) specifies that the 

‘‘National Coordinator, in consultation 

with the Director of the National 

Institute of Standards and Technology, 

shall keep or recognize a program or 

programs for the voluntary certification 

of health information technology as 

being in compliance with applicable 

certification criteria adopted under this 

subtitle’’ (that is, certification criteria 

adopted by the Secretary under section 

3004 of the PHSA). The certification 

program(s) must also ‘‘include, as 

appropriate, testing of the technology in 

accordance with section 13201(b) of the 

[HITECH] Act.’’ 

Section 13201(b) of the HITECH Act 

requires that with respect to the 

development of standards and 

implementation specifications, the 

Director of the National Institute of 

Standards and Technology (NIST), in 

coordination with the HIT Standards 

Committee, ‘‘shall support the 

establishment of a conformance testing 

infrastructure, including the 

development of technical test beds.’’ 

The HITECH Act also indicates that 

‘‘[t]he development of this conformance 

testing infrastructure may include a 

program to accredit independent, nonFederal laboratories to perform testing.’’ 

3. Medicare and Medicaid Electronic 

Health Record (EHR) Incentive Programs 

We described the legislative basis for 

the Medicare and Medicaid EHR 

Incentive Programs in our Stage 1 and 

2 final rules. Such legislative basis 

remains the same for this interim final 

rule with comment period. We refer 

readers to the Stage 1 and 2 final rules 

(75 FR 44316 through 44317; 77 FR 

53970) for discussions of legislative 

basis, including sections 1848(o), 

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

1903(a)(3)(F), and 1903(t) of the Social 

Security Act (the Act). 

B. Regulatory History 

1. Standards, Implementation 

Specifications, and Certification Criteria 

Rules 

In the September 4, 2012 Federal 

Register (77 FR 54163), the Secretary 

issued a final rule (the ‘‘2014 Edition 

EHR certification criteria final rule’’) 

that adopted the 2014 Edition EHR 

certification criteria and a revised 

Certified EHR Technology (CEHRT) 

definition. The standards, 

implementation specifications, and 

certification criteria adopted by the 

Secretary in the final rule established 

the capabilities that CEHRT must 

include in order to, at a minimum, 

support the achievement of meaningful 

use (MU) by eligible professionals (EPs), 

eligible hospitals, and critical access 

hospitals (CAHs) under the Medicare 

and Medicaid EHR Incentive Programs 

beginning with the EHR reporting 

periods in FY/CY 2014. 

The Secretary previously issued an 

interim final rule (75 FR 2014, January 

13, 2010) and final rule (75 FR 44590, 

July 28, 2010) which adopted an initial 

set of standards, implementation 

specifications, and certification criteria 

and a CEHRT definition to support MU 

(the ‘‘2011 Edition EHR certification 

criteria final rule’’). In the October 13, 

2010 Federal Register (75 FR 62686), an 

interim final rule with comment period 

was issued to remove certain 

implementation specifications related to 

public health surveillance that had been 

previously adopted in the final rule. 

2. HIT Certification Programs Rules 

In the 2014 Edition EHR certification 

criteria final rule previously mentioned 

above, ONC made revisions to the 

permanent certification program, 

including changing the program’s name 

to the ONC HIT Certification Program. 

Previously, the Secretary issued a final 

rule on January 7, 2011 (76 FR 1262) 

establishing the permanent certification 

program’s requirements (now called the 

ONC HIT Certification Program) and a 

final rule on June 24, 2010 (75 FR 

36158) establishing the temporary 

certification program. 

3. Medicare and Medicaid EHR 

Incentive Programs Rules 

CMS’s final rule (the ‘‘Stage 2 final 

rule’’) implementing Stage 2 of 

meaningful use appeared in the 

September 4, 2012 Federal Register (77 

FR 53968). The final rule also contained 

some revisions to Stage 1 of meaningful 

use, beginning with EHR reporting 

periods in FY/CY 2013. A correction 

notice appeared in the October 23, 2012 

Federal Register (77 FR 64755). 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 77, No. 236 / Friday, December 7, 2012 / Rules and Regulations 72987 

1http://www.cms.gov/Regulations-and-Guidance/ 

Legislation/EHRIncentivePrograms/ 

2014_ClinicalQualityMeasures.html. 

2http://www.nlm.nih.gov/healthit/dec/. 

3http://www.hl7.org/permalink/ 

?CDAR2_IG_QRDA_CATIII_R1_NOV. 

II. Provisions of the Interim Final Rule 

With Comment Period 

A. Adoption and Incorporation by 

Reference of Newer Versions of the DEC 

and QRDA III Standards 

1. Data Element Catalog 

In the 2014 Edition EHR certification 

criteria final rule (77 FR 54163), we 

adopted the Data Element Catalog 

(DEC), August 2012 version, standard at 

45 CFR 170.204(c) and incorporated the 

standard by reference at 45 CFR 

170.299(m)(5). The DEC is included in 

the certification criterion at 45 CFR 

170.314(c)(1), which requires EHR 

technology presented for certification to 

be able to electronically record all of the 

data identified in the DEC that would be 

necessary to calculate each clinical 

quality measure (CQM). 

On October 25, 2012, CMS released 

the final 2014 CQM electronic 

specifications (e-specifications).1 In 

preparation for that release, we 

performed a gap analysis to determine 

whether the DEC, August 2012 version 

(now referred to as ‘‘DEC version 1.0’’) 

still appropriately specified all of the 

data that EHR technology would need to 

capture to support these final 2014 CQM 

e-specifications. Based on that analysis, 

we determined that the version of the 

DEC we adopted in the final rule needed 

to be updated in order to correctly align 

with data capture expectations 

expressed by numerous 2014 CQM especifications. Working with our 

colleagues at the National Library of 

Medicine (NLM), a new version of the 

DEC (version 1.1) 2 is now available that 

fully aligns with the final 2014 CQM especifications. By replacing the version 

of the DEC that is currently incorporated 

by reference at 45 CFR 170.299(m)(5) 

with an updated version (Data Element 

Catalog, Version 1.1 (October 2012)), 

EHR technology certified under the 

ONC HIT Certification Program will be 

capable of supporting the electronic 

capture of all of the necessary data for 

CQM calculation and submission by 

EPs, eligible hospitals, and CAHs for the 

Medicare and Medicaid EHR Incentive 

Programs. Based on our expectation that 

EHR technology testing and certification 

will begin in January 2013, if we do not 

act now to immediately update the 

version of the DEC currently 

incorporated by reference, EHR 

technology would be required to be 

tested and certified to DEC version 1.0 

and thus capture, in some cases, less 

data than necessary to support the 

accurate calculation and reporting of the 

2014 CQMs. As a consequence, CMS 

and the States would then receive 

incomplete CQM data from EPs, eligible 

hospitals, and CAHs. Therefore, we are 

replacing the version of the DEC that is 

currently incorporated by reference at 

45 CFR 170.299(m)(5) with the updated 

version (DEC, Version 1.1 (October 

2012)) that we are adopting as the 

standard referenced by the 2014 Edition 

EHR certification criterion at 45 CFR 

170.314(c)(1). 

2. Quality Reporting Document 

Architecture (QRDA) Category III 

(QRDA III) 

In the 2014 Edition EHR certification 

criteria final rule, we adopted the QRDA 

III, Release 1, standard at 45 CFR 

170.205(k) and incorporated the 

standard by reference at 45 CFR 

170.299(f)(14). The QRDA III is included 

in the certification criterion at 45 CFR 

170.314(c)(3), which requires EHR 

technology presented for certification to 

be capable of electronically creating a 

data file for transmission of clinical 

quality measurement data in accordance 

with QRDA III and that can be 

electronically accepted by CMS. 

As noted in the 2014 Edition EHR 

certification criteria final rule (77 FR 

54232), we adopted QRDA III 

(specifically, Quality Reporting 

Document Architecture Category III, 

Release 1, Implementation Guide for 

CDA Release 2 (US Realm) Based on 

HL7 CDA Release 2.0, August 2012) 

even though it had not been balloted 

because we expected it to become a 

normative standard in the near future 

and agreed with CMS’s decision to 

select this format rather than developing 

its own CMS-defined XML template 

because QRDA III is a product of several 

years of industry consensus work. The 

QRDA III standard has now been 

successfully balloted (specifically, HL7 

Implementation Guide for CDA®

Release 2: Quality Reporting Document 

Architecture—Category III, DSTU 

Release 1 (US Realm) Draft Standard for 

Trial Use, November 2012).3 The 

November 2012 balloted version of 

QRDA III clarifies ambiguities in the 

August version we adopted; specifically, 

certain data that would need to be 

included in any QRDA III file submitted 

to CMS, such as a provider’s National 

Provider Identifier (NPI) or Taxpayer 

Identification Number (TIN) in order for 

the electronic submission to be properly 

processed. Additionally, some of the 

required components have been 

changed to optional in the November 

2012 balloted version of the standard, 

which may reduce the burden for EHR 

technology developers. Finally, we are 

making this change because CMS 

intends to implement its electronic 

submission systems to receive QRDA III 

files formatted according to the 

November 2012 balloted version. For 

these reasons, we are replacing the 

version of the QRDA III that is currently 

incorporated by reference at 45 CFR 

170.299(f)(14) with the November 2012 

balloted version of QRDA III that we are 

adopting as the standard referenced by 

the 2014 Edition EHR certification 

criterion at 45 CFR 170.314(c)(3). 

B. Revisions to the Medicare and 

Medicaid EHR Incentive Programs 

1. Meaningful Use Criteria 

a. Stage 2 Hospital Objective for 

Providing Electronic Lab Results to 

Ambulatory Providers 

In the Stage 2 final rule (77 FR 54041 

through 54043), we included the 

following objective and measure in the 

Stage 2 menu set for eligible hospitals 

and CAHs at 42 CFR 495.6(m)(6)(i) and 

(ii): 

Objective: Provide structured 

electronic lab results to ambulatory 

providers. 

Measure: Hospital labs send 

structured electronic clinical lab results 

to the ordering provider for more than 

20 percent of electronic lab orders 

received. 

The measure denominator is limited 

to lab orders received electronically by 

the hospital. In our response to 

comments in the Stage 2 final rule (77 

FR 54042), we recognized that this 

measure is based on some degree of 

electronic health information exchange 

taking place between the hospital and 

the ordering provider. The measure 

denominator assumes that if a hospital 

does not receive a lab order 

electronically, it would be less likely to 

send the results electronically to the 

ordering provider. Upon further 

consideration, however, in cases where 

hospitals send a large number of lab 

results electronically in response to 

orders they receive through nonelectronic means (for example, by phone 

or on paper), the measure might not 

capture a hospital’s performance of the 

objective. In addition, a hospital that 

receives a very small percentage of its 

total lab orders electronically could 

have difficulty meeting the measure 

threshold regardless of the number of 

lab results it sends electronically to 

ordering providers. For example, if a 

hospital receives 10,000 lab orders and 

responds to 4,000 with structured 

electronic clinical lab results, but only 


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72988 Federal Register / Vol. 77, No. 236 / Friday, December 7, 2012 / Rules and Regulations 

100 of those orders were received 

electronically and of those 18 were 

responded to with structured electronic 

clinical lab results, then the hospital 

would score 18/100 and fail to meet the 

measure’s 20-percent threshold despite 

sending 4,000 structured electronic 

clinical lab results. 

While we continue to believe that 

most hospitals will find it advantageous 

to use the existing measure, for the 

reasons discussed previously, we are 

adding an alternative measure for this 

objective. Hospitals can meet either the 

existing measure or the alternative 

measure to satisfy the objective. The 

alternative measure is ‘‘Hospital labs 

send structured electronic clinical lab 

results to the ordering provider for more 

than 20 percent of lab orders received’’ 

at § 495.6(m)(6)(ii)(B). The denominator, 

numerator, and threshold for this 

alternative measure are as follows: 

• Denominator: The number of lab 

orders received from ambulatory 

providers. 

• Numerator: The number of lab 

orders in the denominator for which 

structured electronic clinical lab results 

were sent to the ordering provider. 

• Threshold: The resulting percentage 

must be greater than 20 percent. 

The existing measure of ‘‘Hospital 

labs send structured electronic clinical 

lab results to the ordering provider for 

more than 20 percent of electronic lab 

orders received’’ will be redesignated as 

42 CFR 495.6(m)(6)(ii)(A). We clarify the 

numerator, denominator, and threshold 

of the existing measure as follows: 

• Denominator: The number of 

electronic lab orders received from 

ambulatory providers. 

• Numerator: The number of lab 

orders in the denominator for which 

structured electronic clinical lab results 

were sent to the ordering provider. 

• Threshold: The resulting percentage 

must be greater than 20 percent. 

b. Stages 1 and 2 Hospital Objective for 

View, Download, and Transmit 

In the Stage 2 final rule (77 FR 54041 

through 54043), we included the 

following objective and two associated 

measures in the Stage 2 core set for 

eligible hospitals and CAHs at 42 CFR 

495.6(l)(8)(i) and (ii). We also included 

the objective and measure in the Stage 

1 core set for eligible hospitals and 

CAHs at 42 CFR 495.6(f)(12)(i)(B) and 

(ii)(B). 

Objective: Provide patients the ability 

to view online, download, and transmit 

information about a hospital admission. 

Measures: (A) More than 50 percent of 

all patients who are discharged from the 

inpatient or emergency department 

(POS 21 or 23) of an eligible hospital or 

CAH have their information available 

online within 36 hours of discharge; and 

(B) More than 5 percent of all patients 

who are discharged from the inpatient 

or emergency department (POS 21 or 23) 

of an eligible hospital or CAH (or their 

authorized representative) view, 

download or transmit to a third party 

their information during the EHR 

reporting period. 

In the Stage 2 final rule (77 FR 53968), 

we inadvertently omitted the word 

‘‘unique’’ from the regulation text for 

the two measures. We described in the 

preamble of the final rule (77 FR 54040) 

the denominators of the measures as 

‘‘Number of unique patients discharged 

from an eligible hospital’s or CAH’s 

inpatient or emergency department 

(POS 21 or 23) during the EHR reporting 

period.’’ However, the regulation text 

for these measures incorrectly refers to 

‘‘all patients’’ instead of ‘‘all unique 

patients.’’ Because we intended for the 

regulation text to be consistent with the 

measure specifications as described in 

the preamble, we are correcting the 

regulation text at § 495.6(f)(12)(ii)(B), 

(l)(8)(ii)(A), and (l)(8)(ii)(B) to clarify 

that these measures are based on the 

number of unique patients discharged 

from a hospital’s inpatient or emergency 

department during the EHR reporting 

period. 

2. Case Number Threshold Exemption 

for CQM Reporting for Hospitals 

In the Stage 2 proposed rule, CMS 

solicited comments on whether a case 

number threshold would be appropriate 

for hospital clinical quality measures 

reporting, given the apparent burden on 

hospitals that very seldom have the 

types of cases addressed by certain 

measures. We requested comments on 

whether such thresholds should be 

established for 2013, noting that the 

issue would be mitigated beginning in 

2014 by our proposal to establish a 

larger menu set of CQMs from which 

hospitals would select. 

As we stated in the Stage 2 final rule 

(77 FR 54080), many commenters noted 

that the implementation of a case 

number threshold for hospital CQM 

reporting would help reduce the burden 

placed on hospitals that very seldom 

have cases that would be counted in the 

denominator of certain CQMs. 

Commenters suggested a variety of 

possible implementation mechanisms, 

but all commenters responded to the 

premise that the threshold would be in 

effect in FY 2013. 

In the Stage 2 final rule, we adopted 

a policy that would apply beginning in 

FY 2014. Under such policy, eligible 

hospitals and CAHs with 5 or fewer 

inpatient discharges per quarter or 20 or 

fewer inpatient discharges per year 

(Medicare and non-Medicare 

combined), as defined by a CQM’s 

denominator population, would be 

exempted from reporting on that CQM. 

We stated that the exemption would be 

available in all stages of meaningful use 

beginning in FY 2014, but that eligible 

hospitals and CAHs that submit CQMs 

through attestation (because they are 

demonstrating meaningful use for the 

first time) would not be able to qualify 

for the exemption. We explained that 

the burden of submitting aggregate 

population and sample size counts in 

order to qualify for the exemption 

would be at least equal to the effort 

required to obtain and attest to the 

calculated CQM data. 

Upon further review of this policy, we 

believe there are valid reasons to make 

this policy applicable for EHR reporting 

periods in FY 2013, as well as for 

eligible hospitals and CAHs that are 

submitting their CQMs through 

attestation. For FY 2013, eligible 

hospitals and CAHs are required to 

submit information on each of the 15 

CQMs that were finalized for FYs 2011 

and 2012 in the Stage 1 final rule (75 FR 

44418 through 44420). Because they do 

not have a choice as to which CQMs to 

report for FY 2013, hospitals may 

experience the burden of revising 

workflow in order to accurately report 

on CQMs for which they have fewer 

than 20 cases per year. In addition, after 

considering the workflow redesign costs 

that could be incurred by training staff 

to input data used in calculating lowvolume CQMs, we have re-assessed the 

burdens of attesting to calculated CQM 

data and submitting aggregate 

population and sample size counts in 

order to qualify for the exemption. 

Therefore, we are finalizing a case 

threshold exemption that is applicable 

for eligible hospitals and CAHs in all 

stages of meaningful use beginning with 

FY 2013. Eligible hospitals and CAHs 

that are demonstrating meaningful use 

for the first time and submitting their 

CQMs using attestation would be able to 

qualify for the exemption. Eligible 

hospitals and CAHs with 5 or fewer 

discharges during the relevant EHR 

reporting period (if attesting to a 90-day 

EHR reporting period), or 20 or fewer 

discharges during the year (if attesting 

to a full year EHR reporting period) as 

defined by the CQM’s denominator 

population would be exempted from 

reporting on that CQM. 

In FY 2013, since the reporting 

requirement is to report all 15 of the 

CQMs finalized in the Stage 1 final rule, 

invoking the case threshold exemption 

would reduce the number of CQMs a 

hospital would be required to report by 


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Federal Register / Vol. 77, No. 236 / Friday, December 7, 2012 / Rules and Regulations 72989 

the number of CQMs for which it does 

not meet the case threshold of 

discharges as described earlier. For 

example, if the hospital submitted 

aggregate population and sample size 

data reflecting 4 stroke patients 

discharged in FY 2013, then the hospital 

would be exempt from reporting the 

CQMs that include stroke patients as 

part of the denominator population (that 

is, the 7 stroke CQMs out of the total 15 

CQMs). Therefore, this hospital would 

successfully meet the CQM reporting 

requirements in FY 2013 if they submit 

the 8 remaining CQMs. If a hospital 

does not reach the case threshold for all 

15 CQMs, the hospital would be exempt 

from reporting all CQMs. 

Beginning in FY 2014, the reporting 

requirement is to report 16 CQMs 

covering at least 3 domains from a list 

of 29 CQMs. The hospital would follow 

the same process as in FY 2013, but in 

order to be exempted from reporting 

fewer than 16 CQMs it would need to 

qualify for the case threshold exemption 

for more than 13 of the 29 CQMs. If the 

hospital does not meet the case 

threshold for 13 or fewer CQMs, the 

hospital would be able to report at least 

16 CQMs. Likewise, if the CQMs for 

which the hospital can meet the case 

threshold of discharges do not cover at 

least 3 domains, the hospital would be 

exempt from the requirement to cover 

the remaining domains. For example, if 

the hospital does not meet the case 

threshold of discharges for 13 CQMs, 

and thus could report 16 CQMs, but the 

16 CQMs cover only 2 of the 3 domains, 

then the hospital would be exempt from 

covering the third domain. 

To be eligible for the exemption, 

Medicare-eligible hospitals and CAHs 

must use the same process outlined in 

the Stage 2 final rule (see 77 FR 54080), 

including submitting aggregate 

population and sample size counts for 

Medicare and non-Medicare discharges 

as defined by the CQM’s denominator 

population for the EHR reporting period 

no later than November 30 after the end 

of the fiscal year containing the EHR 

reporting period (for example, 

November 30, 2013 for the hospital’s 

EHR reporting period that occurs in FY 

2013). Medicaid-only hospitals, 

including children’s hospitals, must 

report this same information to the state 

to which they attest, in a manner 

specified by that state. 

3. Technical Corrections to CQM 

Electronic Specifications 

During the time period since the final 

2014 CQM e-specifications were 

released on October 25, 2012, we have 

identified technical errors in a few of 

the e-specifications that, if not 

corrected, would produce inaccurate 

results. In order to maintain the 

integrity of the CQM(s) affected by such 

errors, and to allow for accurate 

reporting of the measure(s), CMS will 

issue technical corrections to the especifications released on October 25, 

2012. We expect to issue these 

corrections on or around December 21, 

2012. In order to meet this date, we are 

encouraging individuals and 

organizations (in particular, vendors 

and system implementers) that have 

identified logic or other technical issues 

with any of the e-specifications released 

on October 25, 2012 to submit the issues 

to the following email address no later 

than December 10, 2012 (HIT_quality_

measurement@CMS.hhs.gov). The 

corrected e-specifications will be 

required both for certification and 

reporting purposes. 

III. Waiver of Proposed Rulemaking 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register to provide a period for public 

comment before the provisions of the 

rule take effect in accordance with 

section 553(b) of the Administrative 

Procedure Act (APA) (5 U.S.C. 553(b)). 

However, we can waive the notice and 

comment procedure if the Secretary 

finds good cause that a notice and 

comment procedure is impracticable, 

unnecessary, or contrary to the public 

interest, and incorporates a statement of 

the finding and the reasons in the final 

notice or rule that is issued. 

A. Adoption of Newer Versions of the 

DEC and QRDA III Standards 

Under the regulatory framework we 

have established, EHR technology will 

be certified under the ONC HIT 

Certification Program and subsequently 

used by EPs, eligible hospitals, and 

CAHs to participate in the Medicare and 

Medicaid EHR Incentive Programs. We 

believe it would be contrary to the 

public interest if EHR technology is 

required to be certified to the versions 

of the DEC and QRDA III standards that 

we adopted in the 2014 Edition EHR 

certification criteria final rule. With 

respect to the DEC standard, the EHR 

technology would not be fully capable 

of electronically capturing all 

potentially necessary CQM data for 

electronic submission to CMS or the 

States under the Medicare and Medicaid 

EHR Incentive Programs. With respect 

to the QRDA III standard, the August 

2012 version did not specify certain 

data that would need to be included in 

a QRDA III file submitted to CMS in 

order for the electronic submission to be 

properly processed. As we noted in 

section II.A.1 of this interim final rule 

with comment period, this update is 

necessary to prevent EHR technology 

from being required to be tested and 

certified to DEC version 1.0 and thus 

capture, in some cases, less data than 

necessary to support the accurate 

calculation and reporting of the 2014 

CQMs. As a consequence, this would 

lead to CMS and the States receiving 

incomplete CQM data from EPs, eligible 

hospitals, and CAHs. Similarly, with 

respect to our adoption of the November 

2012 balloted version of QRDA III, we 

believe that this step is necessary for a 

number of reasons, including: (1) The 

changes in the November 2012 version 

provide necessary clarifications that 

reduce implementation ambiguity and 

ensure that the data CMS needs to 

properly process electronically 

submitted QRDA III files is captured 

and transmitted; and (2) CMS’s 

intentions to implement its electronic 

submission systems to receive QRDA III 

files formatted according to the 

November 2012 balloted version. 

Accordingly, by adopting the new 

versions of the DEC and QRDA III 

standards in this interim final rule with 

comment period to replace the 

previously adopted versions, we can 

facilitate the development and 

certification of EHR technology to 

standards that can fully support the 

electronic capture and electronic 

submission of CQM data under the 

Medicare and Medicaid EHR Incentive 

Programs, which benefits the public 

interest. 

Finally, because testing and 

certification of EHR technology to the 

2014 Edition EHR certification criteria is 

expected to begin in January 2013, 

updating these standards in advance 

would avoid the scenario where EHR 

technology would be certified to 

different versions of these standards, 

and consequently, some EHR 

technology may need to be re-developed 

and re-certified to meet the new 

versions of the standards. Based on this 

timeframe for EHR technology 

developers, and the additional time 

providers will need for adoption and 

implementation of certified EHR 

technology, we believe it would be 

impracticable and contrary to the public 

interest to undergo notice and comment 

rulemaking to adopt the new versions of 

the DEC and QRDA III standards. 

B. Modifications to Meaningful Use 

Hospital Objectives 

The alternative measure for the Stage 

2 hospital objective of ‘‘provide 

structured electronic lab results to 

ambulatory providers’’ (42 CFR 

495.6(m)(6)) that we are finalizing in 

this rule relieves a restriction on eligible 


srobinson on DSK4SPTVN1PROD with 
72990 Federal Register / Vol. 77, No. 236 / Friday, December 7, 2012 / Rules and Regulations 

hospitals and CAHs. The correction of 

the regulation text for the measures 

associated with the hospital objective of 

‘‘provide patients the ability to view 

online, download, and transmit 

information about a hospital admission’’ 

(42 CFR 495.6(f)(12)(i)(B) and 

495.6(l)(8)(i)) is necessary to ensure 

accurate certification of EHR 

technologies. It would also be 

impracticable and contrary to the public 

interest to engage in notice and 

comment rulemaking to finalize these 

modifications. Because these measures 

are percentage-based, they are linked to 

the certification criteria that ONC has 

adopted at 45 CFR 170.314(g)(1) and 

(g)(2). Thus, if we did not institute these 

changes in a timely manner, it could 

potentially delay the certification of 

EHR technology to the 2014 Edition 

EHR certification criteria, which as 

noted in the preceding section is 

expected to begin in January 2013. A 

delay in the availability of certified EHR 

technology could negatively affect 

hospitals’ ability to make informed 

purchasing decisions and shorten their 

timeframe to implement EHR 

technology certified to the 2014 Edition 

EHR certification criteria. We believe 

many hospitals would benefit from the 

certainty of knowing these changes as 

they begin their planning and analysis 

in advance of purchasing and updating 

their EHR technology. Furthermore, if 

there were to be a delay in the 

certification of EHR technology to the 

criteria adopted at 45 CFR 170.314(g)(1) 

and (g)(2), it could prevent hospitals 

from adopting and using 2014 Edition 

EHR technology to meet the CEHRT 

definition in FY 2013. For these reasons, 

there is good cause to make the changes 

to the objectives and measures effective 

prior to receiving public comment. 

C. Case Number Threshold Exemption 

for CQM Reporting 

The low case number threshold 

exemption we are finalizing in this rule 

relieves a restriction on eligible 

hospitals and CAHs. It also is contrary 

to the public interest, impracticable, and 

unnecessary to engage in notice and 

comment rulemaking to finalize this 

exemption. As CMS already received 

comments regarding the exemption 

being available for those hospitals 

reporting CQMs beginning in FY 2013, 

we believe it would be unnecessary to 

engage in another round of comments. 

In addition, eligible hospitals and CAHs 

require immediate notification of the 

exemption to be able to invoke it for 

EHR reporting periods in FY 2013; it 

would not be possible to engage in 

notice and comment rulemaking in 

time. It also benefits the public interest 

if eligible hospitals and CAHs, to the 

extent possible, do not encounter the 

burden of complying with reporting on 

CQMs for which they have case 

numbers beneath our thresholds. For 

these reasons, there is good cause to 

make the case number threshold 

exemption effective prior to receiving 

public comment. 

IV. Response to Comments 

Because of the 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 of that document. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

VI. Regulatory Impact Statement 

We have examined the impact of this 

interim final rule with comment period 

as required by Executive Order 12866 

on Regulatory Planning and Review 

(September 30, 1993), Executive Order 

13563 on Improving Regulation and 

Regulatory Review (February 2, 2011), 

the Regulatory Flexibility Act (5 U.S.C. 

601 et seq.), section 1102(b) of the 

Social Security Act, section 202 of the 

Unfunded Mandates Reform Act of 1995 

(2 U.S.C. 1532), and Executive Order 

13132 on Federalism (August 4, 1999). 

A. Executive Orders 12866 and 13563— 

Regulatory Planning and Review 

Analysis 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). A regulatory impact analysis 

(RIA) must be prepared for major rules 

with economically significant effects 

($100 million or more in any 1 year). 

This interim final rule with comment 

period does not reach the economic 

threshold and, thus, is not considered a 

major rule. Therefore, an RIA has not 

been prepared. 

B. Regulatory Flexibility Act and Social 

Security Act Section 1102(b) 

The Regulatory Flexibility Act (RFA) 

requires agencies to analyze options for 

regulatory relief of small businesses if a 

rule has a significant impact on a 

substantial number of small entities. 

Similarly, CMS is also required by 

section 1102(b) of the Act to prepare an 

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 604 of the RFA. We do not 

believe that the changes in this interim 

final rule with comment period alter 

any of the prior analyses we performed 

for the 2014 Edition EHR certification 

criteria final rule or the Stage 2 final 

rule; and therefore, the Secretary 

certifies that this interim final rule with 

comment period will not have a 

significant impact on a substantial 

number of small entities. 

C. Executive Order 13132—Federalism 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a final 

rule (including an interim final rule) 

that imposes substantial direct 

requirement costs on state and local 

governments, preempts state law, or 

otherwise has federalism implications. 

Because this interim final rule with 

comment period does not impose any 

costs on state or local governments, the 

requirements of Executive Order 13132 

are not applicable. 

D. Unfunded Mandates Reform Act of 

1995 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 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. 

The current inflation-adjusted statutory 

threshold is approximately $139 

million. This interim final rule with 

comment period will not impose an 

unfunded mandate on state, local, and 

tribal governments or on the private 

sector that will reach the threshold 

level. 

The Office of Management and Budget 

reviewed this interim final rule with 

comment period. 

List of Subjects 

42 CFR Part 495 

Administrative practice and 

procedure, Electronic health records, 

Health facilities, Health professions, 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 77, No. 236 / Friday, December 7, 2012 / Rules and Regulations 72991 

Health maintenance organizations 

(HMO), Medicaid, 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 set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services amends 42 CFR part 

495 and the Department amends 45 CFR 

subtitle A, subchapter D, 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 495.6 is amended as 

follows: 

■ a. In paragraph (f)(12)(ii)(B), by 

removing the phrase ‘‘all patients who 

are discharged’’ and adding in its place 

the phrase ‘‘all unique patients who are 

discharged’’. 

■ b. In paragraphs (l)(8)(ii)(A) and (B), 

by removing the phrases ‘‘all patients 

who are discharged’’ and adding in its 

place the phrases ‘‘all unique patients 

who are discharged’’. 

■ c. By revising paragraph (m)(6)(ii). 

The revision reads as follows: 

§ 495.6 Meaningful use objectives and 

measures for EPs, eligible hospitals, and 

CAHs. 

* * * * * 

(m) * * * 

(6) * * * 

(ii) Measures. Hospital labs send 

structured electronic clinical lab results 

to the ordering provider for more than 

20 percent of— 

(A) The electronic lab orders received; 

or 

(B) The lab orders received. 

Title 45—Public Welfare 

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. 

■ 4. Amend § 170.299 by revising 

paragraphs (f)(14) and (m)(5) to read as 

follows: 

§ 170.299 Incorporation by reference. 

* * * * * 

(f) * * * 

(14) HL7 Implementation Guide for 

CDA® Release 2: Quality Reporting 

Document Architecture—Category III, 

DSTU Release 1 (US Realm) Draft 

Standard for Trial Use, November 2012, 

IBR approved for § 170.205. 

* * * * * 

(m) * * * 

(5) Data Element Catalog, Version 1.1, 

October 2012, IBR approved for 

§ 170.204. 

* * * * * 

Section 3004 of the Public Health 

Service Act and Sections 1102 and 1871 

of the Social Security Act (42 U.S.C. 

1302 and 1395hh). 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program); 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: December 3, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Dated: December 3, 2012. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2012–29607 Filed 12–4–12; 4:15 pm] 

BILLING CODE 4150–45–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 622 

[Docket No. 120718253–2644–02] 

RIN 0648–BC30 

Fisheries of the Caribbean, Gulf of 

Mexico, and South Atlantic; SnapperGrouper Fishery Off the Southern 

Atlantic States; Transferability of Black 

Sea Bass Pot Endorsements 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule. 

SUMMARY: NMFS issues this final rule to 

implement a revision of a disapproved 

action from Amendment 18A (the 

Resubmittal) to the Fishery Management 

Plan (FMP) for the Snapper-Grouper 

Fishery of the South Atlantic Region 

(Amendment 18A), as prepared and 

submitted by the South Atlantic Fishery 

Management Council (Council). This 

final rule allows black sea bass pot 

endorsements to be transferred under 

specific conditions. The intent of this 

rule is to implement the transferability 

action originally submitted in 

Amendment 18A, as clarified in the 

Resubmittal. 

DATES: This rule is effective January 7, 

2013. 

ADDRESSES: Electronic copies of 

Amendment 18A and the Resubmittal 

may be obtained from the Southeast 

Regional Office Web site at http:// 

sero.nmfs.noaa.gov/sf/ 

SASnapperGrouperHomepage.htm. 

Amendment 18A includes an 

Environmental Impact Statement (EIS), 

a Regulatory Flexibility Act Analysis 

(RFA), a Regulatory Impact Review, and 

a Fishery Impact Statement. The 

Resubmittal includes a Regulatory 

Impact Review and a Fishery Impact 

Statement. 

FOR FURTHER INFORMATION CONTACT: Kate 

Michie, 727–824–5305. 

SUPPLEMENTARY INFORMATION: The 

snapper-grouper fishery of the South 

Atlantic is managed under the FMP. The 

FMP was prepared by the Council and 

is implemented through regulations at 

50 CFR part 622 under the authority of 

the Magnuson-Stevens Fishery 

Conservation and Management Act 

(Magnuson-Stevens Act). 

On August 22, 2012, NMFS published 

a notice of availability for the 

Rebsubmittal and requested public 


srobinson on DSK4SPTVN1PROD with