[Federal Register Volume 81, Number 105 (Wednesday, June 1, 2016)]
[Rules and Regulations]
[Pages 34909-34913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12841]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 414

[CMS-1631-F3]
RIN 0938-AS40


Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2016; 
Corrections

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

ACTION: Final rule; correcting amendment.

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SUMMARY: This document corrects technical and typographical errors that 
appeared in the final rule with comment period published in the 
November 16, 2015 Federal Register (80 FR 70886 through 71386) entitled 
``Medicare Program; Revisions to Payment Policies Under the Physician 
Fee Schedule and

[[Page 34910]]

Other Revisions to Part B for CY 2016.'' The effective date for the 
rule was January 1, 2016.

DATES: 
    Effective Date: This correcting document is effective May 31, 2016.
    Applicability Date: The corrections indicated in this document are 
applicable beginning January 1, 2016.

FOR FURTHER INFORMATION CONTACT: Michelle Peterman (410) 786-2591.

SUPPLEMENTARY INFORMATION: 

I. Background

    In FR Doc. 2015-28005 (80 FR 70886 through 71386), the final rule 
entitled ``Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2016'' 
(hereinafter referred to as the CY 2016 PFS final rule with comment 
period), there were a number of technical and typographical errors that 
are identified and corrected in section IV., the Correction of Errors. 
These corrections are applicable as of January 1, 2016.

II. Summary of Errors

A. Summary of Errors in the Preamble

    On page 71138, due to typographical errors, the QualityNet Help 
Desk email address, the qualified clinical data registry (QCDR) data 
validation execution report delivery date, and the email subject are 
incorrect.
    On page 71139, due to typographical errors, the QualityNet Help 
Desk email address, the qualified registry data validation execution 
report delivery date, and the email subject are incorrect.
    On pages 71141 and 71145, we incorrectly stated the Measure 
Application Validation (MAV) process utilized to determine the 
reporting of Physician Quality Reporting System (PQRS) cross-cutting 
resources.
    On page 71147, we inadvertently omitted language restating the 
Consumer Assessment of Healthcare Providers and Systems (CAHPS) 
requirements that apply to groups of 100 or more eligible professionals 
(EPs) that register to participate in the Group Practice Reporting 
Option (GPRO) regardless of reporting mechanism.
    On pages 71148 through 71150, we inadvertently omitted language 
restating the CAHPS requirement for the QCDR reporting option in Table 
28--Summary of Requirements for the 2018 PQRS Payment Adjustment: Group 
Practice Reporting Criteria for Satisfactory Reporting of Quality 
Measures Data via the GPRO.

B. Summary of Errors in Regulation Text

    On page 71380 of the CY 2016 PFS final rule with comment period, we 
inadvertently omitted language in Sec.  414.90(k)(5)(i). In this 
paragraph, we inadvertently omitted language restating the CAHPS 
requirements that apply to groups of 100 or more EPs that register to 
participate in the Group Practice Reporting Option (GPRO) regardless of 
reporting mechanism.

III. Waiver of Proposed Rulemaking

    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 APA notice and comment, and delay in 
effective date requirements; similarly, sections 1871(b)(2)(C) and 
1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and 
comment, and delay in effective date requirements of the Act. Section 
553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an 
agency to dispense with normal notice and comment rulemaking procedures 
for good cause if the agency makes a finding that the notice and 
comment process is impracticable, unnecessary, or contrary to the 
public interest; and includes a statement of the finding and the 
reasons for it in the notice. 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 the agency includes in the rule a statement 
of the finding and the reasons for it.
    In our view, this correcting document does not constitute a 
rulemaking that would be subject to these requirements. This document 
merely corrects typographical and technical errors in the CY 2016 PFS 
final rule with comment period. The corrections contained in this 
document are consistent with, and do not make substantive changes to, 
the policies and payment methodologies that were adopted subject to 
notice and comment procedures in the CY 2016 PFS final rule with 
comment period. As a result, the corrections made through this 
correcting document are intended to ensure that the CY 2016 PFS final 
rule with comment period accurately reflects the policies adopted in 
that rule.
    Even if this were a rulemaking to which the notice and comment 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 CY 2016 PFS final rule with comment period or delaying the 
effective date of the corrections would be contrary to the public 
interest because it is in the public interest to ensure that the CY 
2016 PFS final rule with comment period accurately reflects our final 
policies as soon as possible following the date they take effect. 
Further, such procedures would be unnecessary, because we are not 
altering the payment methodologies or policies, but rather, we are 
simply correcting the Federal Register document to reflect the policies 
that we previously proposed, received comment on, and subsequently 
finalized. This correcting document is intended solely to ensure that 
the CY 2016 PFS final rule with comment period accurately reflects 
these policies. For these reasons, we believe there is good cause to 
waive the requirements for notice and comment and delay in effective 
date.

IV. Correction of Errors

    In FR Doc. 2015-28005 of November 16, 2015 (80 FR 70886), make the 
following corrections:

A. Correction of Errors in the Preamble

    1. On page 71138, second column, second paragraph, lines 8 through 
12, the phrase and sentence ``Desk at [email protected] by 5:00 p.m. 
e.s.t. on June 30, 2016. The email subject should be ``PY2015 Qualified 
Registry Data Validation Execution Report.'' '' are corrected to read 
``Desk at [email protected] by 5:00 p.m. e.s.t. on June 30, 2017. 
The email subject should be ``PY2016 Qualified Registry Data Validation 
Execution Report.'' ''.
    2. On page 71139, third column, fifth full paragraph, lines 8 
through 14, the phrase and sentence ``Desk at [email protected] by 
5:00 p.m. ET on June 30 of the year in which the reporting period 
occurs (that is, June 30, 2016 for reporting periods occurring in 
2016). The email subject should be ``PY2015 Qualified Registry Data 
Validation Execution Report.'' '' are corrected to read ``Desk at 
[email protected]

[[Page 34911]]

hcqis.org by 5:00 p.m. ET on June 30 following the year in which the 
reporting period occurs (that is, June 30, 2017 for the reporting 
periods occurring in 2016). The email subject should be ``PY2016 
Qualified Registry Data Validation Execution Report.'' ''.
    3. On page 71141, first column, first partial paragraph, lines 5 
through 9, the sentence ``In addition, the MAV process will also allow 
us to determine whether an EP should have reported on any of the PQRS 
cross-cutting measures.'' is corrected to read ``Please note, the MAV 
process is not utilized to determine whether an EP should have reported 
on any of the PQRS cross-cutting measures. This analysis occurs prior 
to the EP being subject to MAV.''.
    4. On page 71145, third column, first partial paragraph, lines 4 
through 8, the sentence ``However, please note that the MAV process for 
the 2018 PQRS payment adjustment will now allow us to determine whether 
a group practice should have reported on at least 1 cross-cutting 
measure.'' is corrected to read ``Please note, the MAV process is not 
utilized to determine whether an EP should have reported on any of the 
PQRS cross-cutting measures. This analysis occurs prior to the EP being 
subject to MAV.''.
    5. On page 71147, the third column is corrected by adding the 
following paragraph after the first partial paragraph:

    ``For group practices of 100 or more EPs registered to 
participate in the GPRO via QCDR for the 2018 PQRS payment 
adjustment: The administration of the CAHPS for PQRS survey is 
REQUIRED. Therefore, if reporting via QCDR, these group practices 
must meet the following criterion for satisfactory reporting for the 
2018 PQRS payment adjustment: For the 12-month reporting period for 
the 2018 PQRS payment adjustment, report all CAHPS for PQRS survey 
measures via a certified survey vendor, and report at least 6 
measures available for reporting under a QCDR covering at least 2 of 
the NQS domains, AND report each measure for at least 50 percent of 
the group practice's patients. Of the non-CAHPS for PQRS measures, 
the group practice would report on at least 2 outcome measures, OR, 
if 2 outcomes measures are not available, report on at least 1 
outcome measures and at least 1 of the following types of measures--
resource use, patient experience of care, efficiency/appropriate 
use, or patient safety.''

    6. On page 71148 through 71150, Table 28--Summary of Requirements 
for the 2018 PQRS Payment Adjustment: Group Practice Reporting Criteria 
for Satisfactory Reporting of Quality Measures Data via the GPRO is 
corrected to read as follows:

----------------------------------------------------------------------------------------------------------------
                                   Group practice                          Reporting      Satisfactory reporting
       Reporting  period                size           Measure type        mechanism             criteria
----------------------------------------------------------------------------------------------------------------
12-month (Jan 1-Dec 31, 2016)..  25-99 EPs;         Individual GPRO    Web Interface....  Report on all measures
                                 100+ EPs (if        Measures in the                       included in the web
                                  CAHPS for PQRS     Web Interface.                        interface; AND
                                  does not apply).                                         populate data fields
                                                                                           for the first 248
                                                                                           consecutively ranked
                                                                                           and assigned
                                                                                           beneficiaries in the
                                                                                           order in which they
                                                                                           appear in the group's
                                                                                           sample for each
                                                                                           module or preventive
                                                                                           care measure. If the
                                                                                           pool of eligible
                                                                                           assigned
                                                                                           beneficiaries is less
                                                                                           than 248, then the
                                                                                           group practice must
                                                                                           report on 100 percent
                                                                                           of assigned
                                                                                           beneficiaries. In
                                                                                           other words, we
                                                                                           understand that, in
                                                                                           some instances, the
                                                                                           sampling methodology
                                                                                           we provide will not
                                                                                           be able to assign at
                                                                                           least 248 patients on
                                                                                           which a group
                                                                                           practice may report,
                                                                                           particularly those
                                                                                           group practices on
                                                                                           the smaller end of
                                                                                           the range of 25-99
                                                                                           EPs. If the group
                                                                                           practice is assigned
                                                                                           less than 248
                                                                                           Medicare
                                                                                           beneficiaries, then
                                                                                           the group practice
                                                                                           must report on 100
                                                                                           percent of its
                                                                                           assigned
                                                                                           beneficiaries. A
                                                                                           group practice must
                                                                                           report on at least 1
                                                                                           measure for which
                                                                                           there is Medicare
                                                                                           patient data.
12-month (Jan 1-Dec 31, 2016)..  25-99 EPs that     Individual GPRO    Web Interface +    The group practice
                                  elect CAHPS for    Measures in the    CMS-Certified      must have all CAHPS
                                  PQRS;.             Web Interface +    Survey Vendor.     for PQRS survey
                                 100+ EPs (if        CAHPS for PQRS.                       measures reported on
                                  CAHPS for PQRS                                           its behalf via a CMS-
                                  applies).                                                certified survey
                                                                                           vendor. In addition,
                                                                                           the group practice
                                                                                           must report on all
                                                                                           measures included in
                                                                                           the Web Interface;
                                                                                           AND populate data
                                                                                           fields for the first
                                                                                           248 consecutively
                                                                                           ranked and assigned
                                                                                           beneficiaries in the
                                                                                           order in which they
                                                                                           appear in the group's
                                                                                           sample for each
                                                                                           module or preventive
                                                                                           care measure. If the
                                                                                           pool of eligible
                                                                                           assigned
                                                                                           beneficiaries is less
                                                                                           than 248, then the
                                                                                           group practice must
                                                                                           report on 100 percent
                                                                                           of assigned
                                                                                           beneficiaries. A
                                                                                           group practice will
                                                                                           be required to report
                                                                                           on at least 1 measure
                                                                                           for which there is
                                                                                           Medicare patient
                                                                                           data.
                                                                                          Please note that, if
                                                                                           the CAHPS for PQRS
                                                                                           survey is applicable
                                                                                           to a group practice
                                                                                           who reports quality
                                                                                           measures via the Web
                                                                                           Interface, the group
                                                                                           practice must
                                                                                           administer the CAHPS
                                                                                           for PQRS survey in
                                                                                           addition to reporting
                                                                                           the Web Interface
                                                                                           measures.

[[Page 34912]]

 
12-month (Jan 1-Dec 31, 2016)..  2-99 EPs;          Individual         Qualified          Report at least 9
                                 100+ EPs (if        Measures.          Registry.          measures, covering at
                                  CAHPS for PQRS                                           least 3 of the NQS
                                  does not apply).                                         domains. Of these
                                                                                           measures, if a group
                                                                                           practice sees at
                                                                                           least 1 Medicare
                                                                                           patient in a face-to-
                                                                                           face encounter, the
                                                                                           group practice would
                                                                                           report on at least 1
                                                                                           measure in the PQRS
                                                                                           cross-cutting measure
                                                                                           set. If less than 9
                                                                                           measures covering at
                                                                                           least 3 NQS domains
                                                                                           apply to the group
                                                                                           practice, the group
                                                                                           practice would report
                                                                                           on each measure that
                                                                                           is applicable to the
                                                                                           group practice, AND
                                                                                           report each measure
                                                                                           for at least 50
                                                                                           percent of the
                                                                                           group's Medicare Part
                                                                                           B FFS patients seen
                                                                                           during the reporting
                                                                                           period to which the
                                                                                           measure applies.
                                                                                           Measures with a 0
                                                                                           percent performance
                                                                                           rate would not be
                                                                                           counted.
12-month (Jan 1-Dec 31, 2016)..  2-99 EPs that      Individual         Qualified          The group practice
                                  elect CAHPS for    Measures + CAHPS   Registry + CMS-    must have all CAHPS
                                  PQRS;              for PQRS.          Certified Survey   for PQRS survey
                                 100+ EPs (if                           Vendor.            measures reported on
                                  CAHPS for PQRS                                           its behalf via a CMS-
                                  applies).                                                certified survey
                                                                                           vendor, and report at
                                                                                           least 6 additional
                                                                                           measures, outside of
                                                                                           the CAHPS for PQRS
                                                                                           survey, covering at
                                                                                           least 2 of the NQS
                                                                                           domains using the
                                                                                           qualified registry.
                                                                                           If less than 6
                                                                                           measures apply to the
                                                                                           group practice, the
                                                                                           group practice must
                                                                                           report on each
                                                                                           measure that is
                                                                                           applicable to the
                                                                                           group practice. Of
                                                                                           the additional
                                                                                           measures that must be
                                                                                           reported in
                                                                                           conjunction with
                                                                                           reporting the CAHPS
                                                                                           for PQRS survey
                                                                                           measures, if any EP
                                                                                           in the group practice
                                                                                           sees at least 1
                                                                                           Medicare patient in a
                                                                                           face-to-face
                                                                                           encounter, the group
                                                                                           practice must report
                                                                                           on at least 1 measure
                                                                                           in the PQRS cross-
                                                                                           cutting measure set.
12-month (Jan 1-Dec 31, 2016)..  2-99 EPs;          Individual         Direct EHR         Report 9 measures
                                 100+ EPs (if        Measures.          Product or EHR     covering at least 3
                                  CAHPS for PQRS                        Data Submission    domains. If the group
                                  does not apply).                      Vendor Product.    practice's direct EHR
                                                                                           product or EHR data
                                                                                           submission vendor
                                                                                           product does not
                                                                                           contain patient data
                                                                                           for at least 9
                                                                                           measures covering at
                                                                                           least 3 domains, then
                                                                                           the group practice
                                                                                           must report all of
                                                                                           the measures for
                                                                                           which there is
                                                                                           Medicare patient
                                                                                           data. A group
                                                                                           practice must report
                                                                                           on at least 1 measure
                                                                                           for which there is
                                                                                           Medicare patient
                                                                                           data.
12-month (Jan 1-Dec 31, 2016)..  2-99 EPs that      Individual         Direct EHR         The group practice
                                  elect CAHPS for    Measures + CAHPS   Product or EHR     must have all CAHPS
                                  PQRS;              for PQRS.          Data Submission    for PQRS survey
                                 100+ EPs (if                           Vendor Product +   measures reported on
                                  CAHPS for PQRS                        CMS-Certified      its behalf via a CMS-
                                  applies).                             Survey Vendor.     certified survey
                                                                                           vendor, and report at
                                                                                           least 6 additional
                                                                                           measures, outside of
                                                                                           CAHPS for PQRS,
                                                                                           covering at least 2
                                                                                           of the NQS domains
                                                                                           using the direct EHR
                                                                                           product or EHR data
                                                                                           submission vendor
                                                                                           product. If less than
                                                                                           6 measures apply to
                                                                                           the group practice,
                                                                                           the group practice
                                                                                           must report all of
                                                                                           the measures for
                                                                                           which there is
                                                                                           Medicare patient
                                                                                           data. Of the
                                                                                           additional 6 measures
                                                                                           that must be reported
                                                                                           in conjunction with
                                                                                           reporting the CAHPS
                                                                                           for PQRS survey
                                                                                           measures, a group
                                                                                           practice would be
                                                                                           required to report on
                                                                                           at least 1 measure
                                                                                           for which there is
                                                                                           Medicare patient
                                                                                           data.

[[Page 34913]]

 
12-month (Jan 1-Dec 31, 2016)..  2-99 EPs;          Individual PQRS    Qualified          Report at least 9
                                 100+ EPs (if        measures and/or    Clinical Data      measures available
                                  CAHPS for PQRS     non-PQRS           Registry (QCDR).   for reporting under a
                                  does not apply).   measures                              QCDR covering at
                                                     reportable via a                      least 3 of the NQS
                                                     QCDR.                                 domains, AND report
                                                                                           each measure for at
                                                                                           least 50 percent of
                                                                                           the group practice's
                                                                                           patients. Of these
                                                                                           measures, the group
                                                                                           practice would report
                                                                                           on at least 2 outcome
                                                                                           measures, OR, if 2
                                                                                           outcomes measures are
                                                                                           not available, report
                                                                                           on at least 1 outcome
                                                                                           measures and at least
                                                                                           1 of the following
                                                                                           types of measures--
                                                                                           resource use, patient
                                                                                           experience of care,
                                                                                           efficiency/
                                                                                           appropriate use, or
                                                                                           patient safety.
12-month (Jan 1-Dec 31, 2016)..  2-99 EPs that      Individual PQRS    Qualified          The group practice
                                  elect CAHPS for    measures and/or    Clinical Data      must have all CAHPS
                                  PQRS;              non-PQRS           Registry (QCDR)    for PQRS survey
                                 100+ EPs (if        measures           + CMS-Certified    measures reported on
                                  CAHPS for PQRS     reportable via a   Survey Vendor.     its behalf via a CMS-
                                  applies).          QCDR + CAHPS for                      certified survey
                                                     PQRS.                                 vendor, and report at
                                                                                           least 6 additional
                                                                                           measures, outside of
                                                                                           the CAHPS for PQRS
                                                                                           survey, covering at
                                                                                           least 2 of the NQS
                                                                                           domains using the
                                                                                           QCDR AND report each
                                                                                           measure for at least
                                                                                           50 percent of the
                                                                                           group practice's
                                                                                           patients. Of these
                                                                                           non-CAHPS measures,
                                                                                           the group practice
                                                                                           would report on at
                                                                                           least 2 outcome
                                                                                           measures, OR, if 2
                                                                                           outcomes measures are
                                                                                           not available, report
                                                                                           on at least 1 outcome
                                                                                           measures and at least
                                                                                           1 of the following
                                                                                           types of measures--
                                                                                           resource use, patient
                                                                                           experience of care,
                                                                                           efficiency/
                                                                                           appropriate use, or
                                                                                           patient safety.
----------------------------------------------------------------------------------------------------------------

List of Subjects in 42 CFR Part 414

    Administrative practices and procedure, Health facilities, Health 
professions, Kidney diseases, Medicare, Reporting and recordkeeping 
requirements.

    Accordingly, 42 CFR chapter IV is corrected by making the following 
correcting amendments to part 414:

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
1. The authority citation for part 414 continues to read as follows:

    Authority:  Secs. 1102, 1871, and 1881(b)(l) of the Social 
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).


0
2. Section 414.90 is amended by revising paragraph (k)(5)(i) to read as 
follows:


Sec.  414.90  Physician Quality Reporting System (PQRS).

* * * * *
    (k) * * *
    (5) * * *
    (i) If a group practice does not report the CAHPS for PQRS survey 
measures, report at least 9 measures available for reporting under a 
QCDR covering at least 3 of the NQS domains, and report each measure 
for at least 50 percent of the eligible professional's patients. Of 
these measures, report on at least 3 outcome measures, or, if 3 
outcomes measures are not available, report on at least 2 outcome 
measures and at least 1 of the following types of measures--resource 
use, patient experience of care, efficiency/appropriate use, or patient 
safety. If a group practice reports the CAHPS for PQRS survey measures, 
apply reduced criteria as follows: 6 QCDR measures covering 2 NQS 
domains; and, of the non-CAHPS for PQRS measures, 2 outcome measures or 
1 outcome and 1 other specified type of measure, as applicable.
* * * * *CMS-1631-F3

    Dated: May 25, 2016.
Madhura Valverde,
Executive Secretary to the Department.
[FR Doc. 2016-12841 Filed 5-31-16; 8:45 am]
 BILLING CODE 4120-01-P