[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Rules and Regulations]
[Pages 11447-11449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04785]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 495

[CMS-3310 & 3311-F2]
RINs 0938-AS26 and AS58


Medicare and Medicaid Programs; Electronic Health Record 
Initiative Program--Stage 3 and Modifications to Meaningful Use in 2015 
Through 2017; Corrections and Correcting Amendment

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

ACTION: Final rule; corrections and correcting amendment.

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SUMMARY: This document corrects certain technical and typographical 
errors that appeared in the October 16, 2015 final rule with comment 
period titled ``Medicare and Medicaid Programs; Electronic Health 
Record Incentive Program--Stage 3 and Modifications to Meaningful Use 
in 2015 through 2017.''

DATES: This document is effective on March 4, 2016.

FOR FURTHER INFORMATION CONTACT: Kateisha Martin, (410) 786-4651.

SUPPLEMENTARY INFORMATION:

I. Background

    In FR Doc. 2015-25595 of October 16, 2015 (80 FR 62762), in the 
final rule with comment period titled ``Medicare and Medicaid Programs; 
Electronic Health Record Incentive Program--Stage 3 and Modifications 
to Meaningful Use in 2015 through 2017'' (hereafter referred to as the 
``2015 EHR Incentive Programs final rule with comment period''), there 
were a number of technical errors that are identified and corrected in 
this correcting amendment. The provisions in this document are treated 
as if they had been included in the 2015 EHR Incentive Programs final 
rule with comment period.
    In the 2015 EHR Incentive Programs final rule with comment period, 
we specified the requirements that eligible professionals (EPs), 
eligible hospitals, and critical access hospitals (CAHs) must meet in 
order to participate in the Medicare and Medicaid EHR Incentive 
Programs and successfully demonstrate meaningful use of certified EHR 
technology. In addition, it changed the Medicare and Medicaid EHR 
Incentive Programs reporting period in 2015 to a 90-day period aligned 
with the calendar year. It also removed reporting requirements on 
measures that have become redundant, duplicative, or topped out from 
the Medicare and Medicaid EHR Incentive Programs. In addition, it 
established the requirements for Stage 3 of the program as optional in 
2017 and required for all participants beginning in 2018. The final 
rule with comment period continues to encourage the electronic 
submission of clinical quality measure (CQM) data, establishes 
requirements to transition the program to a single stage, and aligns 
reporting for providers in the Medicare and Medicaid EHR Incentive 
Programs.

II. Summary of Errors

A. Summary of Errors in the Preamble

    On page 62767, in our discussion of certified EHR technology 
requirements for the EHR Incentive Program, we made a typographical 
error in the word ``use'' in the sentence specifying that providers may 
continue to use technology certified to the 2014 Edition until EHR 
technology certified to the 2015 Edition is required with an EHR 
reporting period beginning in 2018.
    On page 62801, in our response to the public comment regarding 
``Objective 4: Electronic Prescribing'' we made a typographical error 
in the word ``distinguish'' in the sentence specifying that we will no 
longer distinguish between prescriptions for controlled substances.
    On page 62806, in our response to a public comment regarding 
``Objective 4: Electronic Prescribing'' and the pathways acceptable for 
transmitting Summary of Care records, we inadvertently omitted the word 
``have'' in the sentence specifying that to count in the numerator the 
sending provider must have reasonable certainty of receipt of the 
summary of care document. In addition, there is typographical error and 
the word ``obtain'' was omitted causing an incomplete sentence which 
reads ``Instead, r the referring provider must confirmation''. This 
sentence is

[[Page 11448]]

corrected to read ``Instead, the referring provider must obtain 
confirmation''.
    On page 62819, we made a typographical error in our discussion 
regarding previous registrations with a public health agency or 
clinical data registry that occurred in a previous stage of meaningful 
use could count toward Active Engagement Option 1 for any of the EHR 
reporting periods in 2015, 2016 or 2017.
    On page 62825, in Table 6--PUBLIC HEALTH REPORTING OBJECTIVE 
MEASURES FOR EPs, ELIGIBLE HOSPITALS, AND CAHs IN 2015 THROUGH 2017, we 
inadvertently included the phrase ``with a public health agency'' in 
the description of the Measure 3 Specialized Registry Reporting 
``Measure Specification'' in error.
    On page 62834, in our response to a public comment regarding the 
eventual progression toward universal inclusion of controlled 
substances in electronic prescribing as a desired goal, we made a 
grammatical error.
    On page 62868, in our response to a public comment regarding 
reporting to specialized registries, we made a typographical error in 
the cross-reference for the section outlining the Specialized Registry 
Reporting measure for 2015 through 2017.
    On page 62885, in Table 15--EP OBJECTIVES, MEASURES, AND 
CERTIFICATION CRITERIA FOR STAGE 3 IN 2018 AND SUBSEQUENT YEARS, we 
made technical errors in the descriptions of Measures 1 and 2 of 
Objective 6--Coordination of Care through Patient Engagement where the 
table text does not match the correct text in the preamble and 
regulation text for the correct year.
    On page 62883, in TABLE 14--ELIGIBLE HOSPITAL/CAH OBJECTIVES, 
MEASURES, AND CERTIFICATION CRITERIA FOR STAGE 3 IN 2017, we made 
technical errors in the threshold description for Measures 1 and 2 of 
Objective 6 where the table text does not match the correct text in the 
preamble and regulation text for the correct year.
    On page 62928, in Table 25--ESTIMATED ANNUAL INFORMATION COLLECTION 
BURDEN, we made typographical errors in the regulatory citations listed 
in the first column of the table.

B. Summary of Errors in the Regulations Text

    On page 62945, in Sec.  495.22(e)(3)(ii)(C)(3), we erroneously 
stated that the alternate exclusion applies for only measure 3 for EPs 
scheduled to be in Stage 1 in 2016 instead of stating that the 
exclusion applies for both measures 2 and 3 for EPs scheduled to be in 
Stage 1 in 2016.
    On page 62948, in Sec.  495.22(e)(10)(ii)(C)(3), we incorrectly 
referenced EPs instead of eligible hospitals or CAHs in specifying the 
exclusion for the immunization registry reporting measure.
    On page 62951, in Sec.  495.24(d)(7)(i)(B)(3), we erroneously 
stated that the provider must implement clinical information 
reconciliation for ``two of the following three'' clinical information 
sets instead of stating that the provider must implement clinical 
information reconciliation for ``the following three'' clinical 
information sets, which is consistent with the proposed regulation text 
(80 FR 16800) and the description in the final rule preamble (80 FR 
62862).
    On page 62952, in Sec.  495.24(d)(7)(ii)(B)(3), we erroneously 
stated that the provider must implement clinical information 
reconciliation for ``two of the following three'' clinical information 
sets instead of stating that the provider must implement clinical 
information reconciliation for ``the following three'' clinical 
information sets, which is consistent with the proposed regulation text 
(80 FR 16801) and the description in the final rule preamble (80 FR 
62862).

III. Waiver of Proposed Rulemaking, 60-Day Comment Period, and Delay in 
Effective Date

    Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), 
the agency is required to publish a notice of the proposed rule in the 
Federal Register before the provisions of a rule take effect. 
Similarly, section 1871(b)(1) of the Act requires the Secretary to 
provide for notice of the proposed rule in the Federal Register and 
provide a period of not less than 60 days for public comment. In 
addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of 
the Act mandate a 30-day delay in effective date after issuance or 
publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA 
provide for exceptions from the notice and comment and delay in 
effective date APA requirements; in cases in which these exceptions 
apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide 
exceptions from the notice and 60-day comment period and delay in 
effective date requirements of the Act as well. Section 553(b)(B) of 
the APA and section 1871(b)(2)(C) of the Act authorize an agency to 
dispense with normal rulemaking requirements for good cause if the 
agency makes a finding that the notice and comment process are 
impracticable, unnecessary, or contrary to the public interest. In 
addition, both section 553(d)(3) of the APA and section 
1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay 
in effective date where such delay is contrary to the public interest 
and an agency includes a statement of support.
    We believe that this document does not constitute a rulemaking that 
would be subject to these requirements. This document corrects 
technical and typographic errors in the preamble and regulation text 
included in the 2015 EHR Incentive Programs final rule with comment 
period. The corrections contained in this document are consistent with, 
and do not make substantive changes to, the policies that were adopted 
subject to notice and comment procedures in the final rule with comment 
period. As a result, the corrections made through this document are 
intended to ensure that the 2015 EHR Incentive Programs final rule with 
comment period accurately reflects the policies adopted in that rule. 
In addition, even if this were a rulemaking to which the notice and 
comment procedures and delayed effective date requirements applied, we 
find that there is good cause to waive such requirements. Undertaking 
further notice and comment procedures to incorporate the corrections in 
this document into the final rule with comment period or delaying the 
effective date would be contrary to the public interest because it is 
in the public's interest for eligible professionals, eligible 
hospitals, and critical access hospitals to be advised, in a timely 
manner, of the meaningful use criteria and EHR reporting periods that 
they must meet in order to qualify for Medicare and Medicaid electronic 
health record incentive payments and avoid payment reductions under 
Medicare, and to ensure that the final rule with comment period 
accurately reflects our policies as of the date they take effect and 
are applicable. Furthermore, such procedures would be unnecessary, as 
we are not altering our policies; rather, we are simply implementing 
correctly the policies that we previously proposed, received comment 
on, and subsequently finalized. This correcting document is intended 
solely to ensure that the 2015 EHR Incentive Programs final rule with 
comment period accurately reflects these policies. Therefore, we 
believe we have good cause to waive the notice and comment and 
effective date requirements.

[[Page 11449]]

IV. Correction of Errors

    In FR Doc. 2015-25595 of October 16, 2015 (80 FR 62762), we are 
making the following corrections:
    1. On page 62767, first column, first full paragraph, line 16, the 
phrase ``continue to usher'' is corrected to read ``continue to use''.
    2. On page 62801, second column, first full paragraph, line 32, the 
phrase ``longer distinguishing between'' is corrected to read ``longer 
distinguish between''.
    3. On page 62806, third column, first paragraph--
    a. Lines 4 and 5, the phrase ``must reasonable certainty'' is 
corrected to read ``must have reasonable certainty''.
    b. Line 9 and 10, the phrase ``Instead, r the referring provider 
must confirmation'' is corrected to read ``Instead, the referring 
provider must obtain confirmation''.
    4. On page 62819, second column, last paragraph, line 12, the 
phrase ``a previous stages'' is corrected to read ``a previous stage''.
    5. On page 62825, in TABLE 6--PUBLIC HEALTH REPORTING OBJECTIVE 
MEASURES FOR EPS, ELIGIBLE HOSPITALS, AND CAHS IN 2015 THROUGH 2017, 
second column (Measure specification column for Measure 3) lines 5 and 
6, the phrase ``The EP, eligible hospital, or CAH is in active 
engagement with a public health agency to submit data to a specialized 
registry'' is corrected to read ``The EP, eligible hospital, or CAH is 
in active engagement to submit data to a specialized registry''.
    6. On page 62834, first column, last paragraph, line 22, the phrase 
``distinguishing between'' is corrected to read ``distinguish 
between''.
    7. On page 62868, second column, first full paragraph, lines 39 and 
40, the phrase ``section aII.B.2.b.x for further information'' is 
corrected to read ``Objective 10 in section II.B.2.a. of this final 
rule for further information''.
    8. On page 62883, in Table 14--ELIGIBLE HOSPITAL/CAH OBJECTIVES, 
MEASURES, AND CERTIFICATION CRITERIA FOR STAGE 3 IN 2017--CONTINUED, 
second column--
    a. Second set of paragraphs, second paragraph (Measure 1 of 
Objective 6), line 2, the phrase ``more than 10 percent'' is corrected 
to read ``more than 5 percent''.
    b. Third set of paragraphs, last paragraph (Measure 2 of Objective 
6) line 1, the phrase ``more than 25%'' is corrected to read ``more 
than 5%''.
    9. On page 62885, in TABLE 15--EP OBJECTIVES, MEASURES, AND 
CERTIFICATION CRITERIA FOR STAGE 3 IN 2018 AND SUBSEQUENT YEARS, second 
column--
    a. Line 17 from the bottom of the column (Measure 1 of Objective 
6), the phrase ``Measure 1: For 2017, during the EHR reporting period'' 
is corrected to read ``Measure 1: During the EHR reporting period''.
    b. Line 6 from the bottom of the column (Measure 2 of Objective 6), 
the phrase ``Measure 2: For 2017, more than 25%'' is corrected to read 
``Measure 2: More than 25%''.
    10. On page 62928, in TABLE 25--ESTIMATED ANNUAL INFORMATION 
COLLECTION BURDEN, the first column (Reg. Section)--
    a. Line 1, the citation ``Sec.  495.x'' is corrected to read 
``Sec.  495.24''
    b. Line 3, the citation ``Sec.  495.6'' is corrected to read 
``Sec.  495.22''.

List of Subjects in 42 CFR Part 495

    Administrative practice and procedure, Electronic health records, 
Health facilities, Health professions, Health maintenance organizations 
(HMO), Medicaid, Medicare, Penalties, Privacy, Reporting and 
recordkeeping requirements.

    As noted in section II.B. of this document, the Centers for 
Medicare & Medicaid Services is making the following correcting 
amendments to 42 CFR part 495:

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY 
INCENTIVE PROGRAM

0
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).


Sec.  495.22  [Amended]

0
2. Section 495.22 is amended as follows:
0
a. In paragraph (e)(3)(ii)(C)(3) by removing the phrase ``paragraph 
(e)(3)(ii)(A)(3) of this section in 2016'' and adding in its place the 
phrase ``paragraphs (e)(3)(ii)(A)(2) and (e)(3)(ii)(A)(3) of this 
section in 2016.''
0
b. In paragraph (e)(10)(ii)(C)(3) introductory text by removing the 
phrase ``if the EP:'' and adding in its place the phrase ``if the 
eligible hospital or CAH:''.


Sec.  495.24  [Amended]

0
3. Section 495.24 is amended as follows:
0
a. In paragraph (d)(7)(i)(B)(3) introductory text by removing the 
phrase ``for two of the following three clinical information sets:'' 
and adding in its place the phrase ``for the following three clinical 
information sets:''.
0
b. In paragraph (d)(7)(ii)(B)(3) introductory text by removing the 
phrase ``for two of the following three clinical information sets:'' 
and adding in its place the phrase ``for the following three clinical 
information sets:''.

    Dated: February 25, 2016.
Wilma Robinson,
Deputy Executive Secretary to the Department, Department of Health and 
Human Services.
[FR Doc. 2016-04785 Filed 3-3-16; 8:45 am]
BILLING CODE 4120-01-P