[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]
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