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

Federal Register, Volume 81 Issue 105 (Wednesday, June 1, 2016)

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:

  1. 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.

  2. Summary of Errors

    1. 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.

    2. 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.

  3. 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.

  4. Correction of Errors

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

    1. Correction of Errors in the Preamble

    1. On page 71138, second column, second paragraph, lines 8 through 12, the phrase and sentence ``Desk at Qnetsupport@sdps.org 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 Qnetsupport@hcqis.org 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 Qnetsupport@sdps.org 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 Qnetsupport@

      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

    7. 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

    8. 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

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