82_FR_46372 82 FR 46181 - Medicare Program; Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom-Fabricated Orthotics; Withdrawal

82 FR 46181 - Medicare Program; Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom-Fabricated Orthotics; Withdrawal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 82, Issue 191 (October 4, 2017)

Page Range46181-46182
FR Document2017-21425

This document withdraws a proposed rule that was published in the Federal Register on January 12, 2017. The proposed rule specified the qualifications needed for qualified practitioners to furnish and fabricate, and qualified suppliers to fabricate prosthetics and custom- fabricated orthotics; accreditation requirements that qualified suppliers must meet in order to bill for prosthetics and custom fabricated orthotics; requirements that an organization must meet in order to accredit qualified suppliers to bill for prosthetics and custom-fabricated orthotics; and a timeframe by which qualified practitioners and qualified suppliers must meet the applicable licensure, certification, and accreditation requirements. In addition, the proposed rule removed the current exemption from accreditation and quality standards for certain practitioners and suppliers.

Federal Register, Volume 82 Issue 191 (Wednesday, October 4, 2017)
[Federal Register Volume 82, Number 191 (Wednesday, October 4, 2017)]
[Proposed Rules]
[Pages 46181-46182]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21425]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 424

[CMS-6012-WN]
RIN 0938-AR84


Medicare Program; Establishment of Special Payment Provisions and 
Requirements for Qualified Practitioners and Qualified Suppliers of 
Prosthetics and Custom-Fabricated Orthotics; Withdrawal

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

ACTION: Withdrawal of proposed rule.

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SUMMARY: This document withdraws a proposed rule that was published in 
the Federal Register on January 12, 2017. The proposed rule specified 
the qualifications needed for qualified practitioners to furnish and 
fabricate, and qualified suppliers to fabricate prosthetics and custom-
fabricated orthotics; accreditation requirements that qualified 
suppliers must meet in order to bill for prosthetics and custom 
fabricated orthotics; requirements that an organization must meet in 
order to accredit qualified suppliers to bill for prosthetics and 
custom-fabricated orthotics; and a timeframe by which qualified 
practitioners and qualified suppliers must meet the applicable 
licensure, certification, and accreditation requirements. In addition, 
the proposed rule removed the current exemption from accreditation and 
quality standards for certain practitioners and suppliers.

DATES: As of October 4, 2017, the proposed rule published January 12, 
2017, at 82 FR 3678, is withdrawn.

FOR FURTHER INFORMATION CONTACT: John Spiegel, (410) 786-1909.

SUPPLEMENTARY INFORMATION: In the January 12, 2017 Federal Register (82 
FR 3678), we published a proposed rule titled, ``Medicare Program; 
Establishment of Special Payment Provisions and Requirements for 
Qualified Practitioners and Qualified Suppliers of Prosthetics and 
Custom Fabricated Orthotics'' to ensure that only those who are 
qualified to do so can furnish, fabricate, and bill for the prosthetics 
and custom-fabricated orthotics addressed by the proposed rule.
    We received over 5,000 public comments in response to the January 
12, 2017 proposed rule.
    In light of the cost and time burdens that the proposed rule would 
create for many providers and suppliers, particularly the cost and 
burden for those providers and suppliers that are small businesses, and 
the complexity of the issues raised in the detailed public comments 
received, we are withdrawing the January 12, 2017 proposed rule in 
order to assure agency flexibility in re-examining the issues and 
exploring options and alternatives with stakeholders.
    Accordingly, the proposed rule published January 12, 2017, at 82 FR 
3678, is withdrawn.


[[Page 46182]]


    Dated: July 21, 2017.
Demetrios L. Kouzoukas,
Principal Deputy Administrator and Director, Center for Medicare.
    Approved: September 7, 2017.
Thomas E. Price,
Secretary, Department of Health and Human Services.
[FR Doc. 2017-21425 Filed 10-3-17; 8:45 am]
 BILLING CODE 4120-01-P



                                                                       Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Proposed Rules                                         46181

                                                  DEPARTMENT OF HEALTH AND                                Following the Supreme Court’s opinion                 Federal Register on January 12, 2017.
                                                  HUMAN SERVICES                                          in Windsor, the Federal government was                The proposed rule specified the
                                                                                                          permitted to recognize the validity of                qualifications needed for qualified
                                                  Centers for Medicare & Medicaid                         same-sex marriages when administering                 practitioners to furnish and fabricate,
                                                  Services                                                Federal statutes and programs.                        and qualified suppliers to fabricate
                                                                                                            The December 2014 rulemaking                        prosthetics and custom-fabricated
                                                  [CMS–3302–WN]
                                                                                                          proposed to revise certain conditions of              orthotics; accreditation requirements
                                                  42 CFR Part 416, 418, 482, 483, and 485                 participation (CoPs), conditions for                  that qualified suppliers must meet in
                                                                                                          coverage (CfCs), and requirements for                 order to bill for prosthetics and custom
                                                  Medicare and Medicaid Programs;                         certain Medicare- and Medicaid-                       fabricated orthotics; requirements that
                                                  Revisions to Certain Patient’s Rights                   participating facilities to ensure that the
                                                                                                                                                                an organization must meet in order to
                                                  Conditions for Participation and                        requirements at issue were consistent
                                                                                                                                                                accredit qualified suppliers to bill for
                                                  Conditions for Coverage; Withdrawal                     with the Windsor decision. We received
                                                                                                          97 public comments in response to the                 prosthetics and custom-fabricated
                                                  AGENCY: Centers for Medicare &                          December 2014 proposed rule.                          orthotics; and a timeframe by which
                                                  Medicaid Services (CMS), HHS.                           Following publication of the proposed                 qualified practitioners and qualified
                                                  ACTION: Withdrawal of proposed rule.                    rule, on June 26, 2015 in Obergefell v.               suppliers must meet the applicable
                                                                                                          Hodges, (135 S. Ct. 2584 (2015)), the                 licensure, certification, and
                                                  SUMMARY:     This document withdraws a                  Supreme Court held that the Due                       accreditation requirements. In addition,
                                                  proposed rule that was published in the                 Process and Equal Protection clauses of               the proposed rule removed the current
                                                  Federal Register on December 12, 2014.                  the Fourteenth Amendment requires a                   exemption from accreditation and
                                                  This proposed rule would revise the                     state to license a marriage between two               quality standards for certain
                                                  applicable conditions of participation                  people of the same sex, and to recognize              practitioners and suppliers.
                                                  for certain providers, conditions for                   same-sex marriages lawfully performed
                                                  coverage for certain suppliers, and                                                                           DATES: As of October 4, 2017, the
                                                                                                          in other States. In light of the Obergefell
                                                  requirements for long-term care                                                                               proposed rule published January 12,
                                                                                                          decision, we have decided to withdraw
                                                  facilities, to ensure that the                                                                                2017, at 82 FR 3678, is withdrawn.
                                                                                                          the December 2014 proposed rule. We
                                                  requirements are consistent with the                    believe that the Obergefell decision has              FOR FURTHER INFORMATION CONTACT:    John
                                                  Supreme Court decision in United                        addressed many of the concerns raised                 Spiegel, (410) 786–1909.
                                                  States v. Windsor (570 U.S.12, 133 S. Ct.               in the December 2014 proposed rule.
                                                  2675 (2013)), and HHS policy.                             Accordingly, the proposed rule                      SUPPLEMENTARY INFORMATION:      In the
                                                  Specifically, it proposed to revise                     published December 12, 2014, at 79 FR                 January 12, 2017 Federal Register (82
                                                  certain definitions and patient’s rights                73873, is withdrawn.                                  FR 3678), we published a proposed rule
                                                  provisions that currently defer to state                                                                      titled, ‘‘Medicare Program;
                                                                                                            Dated: August 24, 2017.
                                                  law, in order to ensure that same-sex                                                                         Establishment of Special Payment
                                                  spouses are recognized and afforded                     Seema Verma,
                                                                                                                                                                Provisions and Requirements for
                                                  equal rights in certain Medicare and                    Administrator, Centers for Medicare &
                                                                                                          Medicaid Services.
                                                                                                                                                                Qualified Practitioners and Qualified
                                                  Medicaid-participating facilities.                                                                            Suppliers of Prosthetics and Custom
                                                                                                            Approved: September 7, 2017.
                                                  DATES: As of October 4, 2017, the                                                                             Fabricated Orthotics’’ to ensure that
                                                                                                          Thomas E. Price,
                                                  proposed rule published December 12,                                                                          only those who are qualified to do so
                                                  2014, at 79 FR 73873, is withdrawn.                     Secretary, Department of Health and Human
                                                                                                                                                                can furnish, fabricate, and bill for the
                                                                                                          Services.
                                                  FOR FURTHER INFORMATION CONTACT:                                                                              prosthetics and custom-fabricated
                                                                                                          [FR Doc. 2017–21419 Filed 10–3–17; 8:45 am]
                                                  Ronisha Blackstone, 410–786–6882.                                                                             orthotics addressed by the proposed
                                                                                                          BILLING CODE 4120–01–P
                                                  SUPPLEMENTARY INFORMATION: On                                                                                 rule.
                                                  December 12, 2014, we published a                                                                                We received over 5,000 public
                                                  proposed rule in the Federal Register                   DEPARTMENT OF HEALTH AND                              comments in response to the January 12,
                                                  entitled, ‘‘Medicare and Medicaid                       HUMAN SERVICES                                        2017 proposed rule.
                                                  Program; Revisions to Certain Patient’s
                                                  Rights Conditions of Participation and                                                                           In light of the cost and time burdens
                                                                                                          Centers for Medicare & Medicaid
                                                  Conditions for Coverage’’ (79 FR 73873).                Services                                              that the proposed rule would create for
                                                  In United States v. Windsor, 570 U.S.12,                                                                      many providers and suppliers,
                                                  133 S. Ct. 2675 (2013), the Supreme                     42 CFR Part 424                                       particularly the cost and burden for
                                                  Court held that section 3 of the Defense                                                                      those providers and suppliers that are
                                                                                                          [CMS–6012–WN]                                         small businesses, and the complexity of
                                                  of Marriage Act (DOMA) was
                                                  unconstitutional because it violated the                RIN 0938–AR84                                         the issues raised in the detailed public
                                                  Fifth Amendment (See Windsor, 133 S.                                                                          comments received, we are withdrawing
                                                  Ct. 2675, 2695). Section 3 of DOMA                      Medicare Program; Establishment of                    the January 12, 2017 proposed rule in
                                                  provided that in determining the                        Special Payment Provisions and                        order to assure agency flexibility in re-
                                                  meaning of any Act of the Congress, or                  Requirements for Qualified                            examining the issues and exploring
                                                  of any ruling, regulation, or                           Practitioners and Qualified Suppliers                 options and alternatives with
sradovich on DSK3GMQ082PROD with PROPOSALS




                                                  interpretation of the various                           of Prosthetics and Custom-Fabricated                  stakeholders.
                                                  administrative bureaus and agencies of                  Orthotics; Withdrawal
                                                                                                                                                                   Accordingly, the proposed rule
                                                  the United States, the word ‘‘marriage’’                AGENCY: Centers for Medicare &                        published January 12, 2017, at 82 FR
                                                  meant only a legal union between one                    Medicaid Services (CMS), HHS.                         3678, is withdrawn.
                                                  man and one woman as husband and                        ACTION: Withdrawal of proposed rule.
                                                  wife, and the word ‘‘spouse’’ could refer
                                                  only to a person of the opposite sex who                SUMMARY: This document withdraws a
                                                  was a husband or a wife (1 U.S.C. 7).                   proposed rule that was published in the


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                                                  46182                Federal Register / Vol. 82, No. 191 / Wednesday, October 4, 2017 / Proposed Rules

                                                    Dated: July 21, 2017.                                 2016 (no earlier than 60 days after the               Secretary of Health and Human Services
                                                  Demetrios L. Kouzoukas,                                 rule was finalized), and phase II would               (the Secretary) under the Health
                                                  Principal Deputy Administrator and Director,            begin no sooner than January 1, 2017.                 Insurance Portability and
                                                  Center for Medicare.                                    The proposed goal was to have both                    Accountability Act of 1996 (HIPAA).
                                                    Approved: September 7, 2017.                          phases of the model in full operation                 This proposed rule would have also
                                                  Thomas E. Price,                                        during the last 3 years of the proposed               established penalty fees for a CHP that
                                                  Secretary, Department of Health and Human               5-year duration to fully evaluate                     failed to comply with the certification of
                                                  Services.                                               changes and collect sufficient data.                  compliance requirements.
                                                  [FR Doc. 2017–21425 Filed 10–3–17; 8:45 am]               We received 1,350 timely public
                                                                                                          comments in response to the March 11,                 DATES: As of October 4, 2017, the
                                                  BILLING CODE 4120–01–P
                                                                                                          2016, proposed rule. Some commenters                  proposed rule published January 2,
                                                                                                          signaled their support for the proposed               2014, at 79 FR 298, is withdrawn.
                                                  DEPARTMENT OF HEALTH AND                                rule, however, a number of commenters                 FOR FURTHER INFORMATION CONTACT:
                                                  HUMAN SERVICES                                          expressed concerns about the proposed                 Geanelle G. Herring, (410) 786–4466.
                                                                                                          model. As we worked to address these
                                                  Centers for Medicare & Medicaid                         concerns, the complexity of the issues                SUPPLEMENTARY INFORMATION:      In the
                                                  Services                                                related to the proposed model design                  January 2, 2014, Federal Register (79 FR
                                                                                                          and the desire to increase stakeholder                298), we published the proposed rule
                                                  42 CFR Part 511                                         input led us to the decision to withdraw              titled ‘‘Administrative Simplification:
                                                                                                          the March 11, 2016 proposed rule.                     Certification of Compliance for Health
                                                  [CMS–1670–WN]                                                                                                 Plans’’ which would have required
                                                                                                          Moving forward, we want to ensure
                                                  RIN 0938–AS85                                           agency flexibility in re-examining these              controlling health plans (CHPs) to
                                                                                                          important issues and exploring new                    submit certain information and
                                                  Medicare Program; Part B Drug                           options and alternatives with                         documentation that demonstrated
                                                  Payment Model; Withdrawal                               stakeholders as we develop potential                  compliance with the standards and
                                                                                                          payment models that support innovative                operating rules adopted under the
                                                  AGENCY: Centers for Medicare &
                                                                                                          approaches to improve quality,                        Health Insurance Portability and
                                                  Medicaid Services (CMS), HHS.
                                                                                                          accessibility, and affordability, reduce              Accountability Act of 1996 (HIPAA) for
                                                  ACTION: Withdrawal of proposed rule.                                                                          three electronic transactions: Eligibility
                                                                                                          Medicare program expenditures, and
                                                  SUMMARY:    This document withdraws a                   empower patients and doctors to make                  for a health plan, health care claim
                                                  proposed rule that was published in the                 decisions about their health care.                    status, and health care electronic funds
                                                  Federal Register on March 11, 2016.                       Accordingly, the proposed rule                      transfers (EFT) and remittance advice.
                                                  The proposed rule discussed our                         published March 11, 2016, at 81 FR                    The proposed rule would have also
                                                  proposal to implement a new Medicare                    13230, is withdrawn.                                  established penalty fees for a CHP that
                                                  payment model under section 1115A of                                                                          failed to comply with the certification of
                                                                                                            Dated: July 17, 2017.                               compliance requirements.
                                                  the Social Security Act (the Act).
                                                                                                          Seema Verma,
                                                  DATES: As of October 4, 2017, the                                                                                We received approximately 72 public
                                                                                                          Administrator, Centers for Medicare &
                                                  proposed rule published March 11,                       Medicaid Services.
                                                                                                                                                                comments in response to the January 2,
                                                  2016, at 81 FR 13230, is withdrawn.                                                                           2014 proposed rule. In light of the
                                                                                                            Dated: August 25, 2017.
                                                  FOR FURTHER INFORMATION CONTACT:                                                                              issues raised in the public comments
                                                                                                          Thomas E. Price,                                      received, we have decided to withdraw
                                                  Rasheeda Johnson, (410) 786–3434.
                                                                                                          Secretary, Department of Health and Human             the January 2014 proposed rule in order
                                                  SUPPLEMENTARY INFORMATION: On March                     Services.
                                                  11, 2016, we published a proposed rule                                                                        to re-examine the issues and explore
                                                                                                          [FR Doc. 2017–21420 Filed 10–3–17; 8:45 am]           options and alternatives to comply with
                                                  in the Federal Register entitled
                                                  ‘‘Medicare Program; Part B Drug
                                                                                                          BILLING CODE 4120–01–P                                the statutory requirements. We note that
                                                  Payment Model’’ (81 FR 13230). The                                                                            the Secretary has established regulations
                                                  rule proposed the Part B Drug Payment                                                                         pertaining to compliance with, and
                                                  Model as a two-phase model that would                   DEPARTMENT OF HEALTH AND                              enforcement of, HIPAA Administrative
                                                  test whether alternative drug payment                   HUMAN SERVICES                                        Simplification standards and operating
                                                  designs will lead to a reduction in                                                                           rules. The withdrawal of this proposed
                                                                                                          Office of the Secretary                               rule does not remove the requirements
                                                  Medicare expenditures, while
                                                  preserving or enhancing the quality of                                                                        for covered entities to comply with any
                                                                                                          45 CFR Parts 160 and 162                              of those regulations codified at 45 CFR
                                                  care provided to Medicare beneficiaries.
                                                  In the first phase, CMS would test a                    [CMS–0037–WN]                                         parts 160 and 162.
                                                  change to the 6 percent add-on to                                                                                Accordingly, the proposed rule
                                                  Average Sales Price (ASP) that is used                  Administrative Simplification:                        published January 2, 2014, at 79 FR 298,
                                                  to make drug payments under Part B                      Certification of Compliance for Health                is withdrawn.
                                                  such that the add-on would be 2.5                       Plans; Withdrawal
                                                                                                                                                                  Dated: August 18, 2017.
                                                  percent plus a flat fee (in a budget                    AGENCY: Office of the Secretary, HHS.                 Seema Verma,
                                                  neutral manner). In the second phase,
sradovich on DSK3GMQ082PROD with PROPOSALS




                                                                                                          ACTION: Withdrawal of proposed rule.                  Administrator, Centers for Medicare &
                                                  we would implement a collection of
                                                                                                                                                                Medicaid Services.
                                                  value-based purchasing tools similar to                 SUMMARY:   This document withdraws the
                                                  those employed by commercial health                     January 2, 2014, proposed rule that                     Dated: August 30, 2017.
                                                  plans, pharmacy benefit managers,                       would have required a controlling                     Thomas E. Price,
                                                  hospitals, and other entities that manage               health plan (CHP) to submit information               Secretary, Department of Health and Human
                                                  health benefits and drug utilization. We                and documentation demonstrating that                  Services.
                                                  proposed to operate the model for 5                     it is compliant with certain standards                [FR Doc. 2017–21424 Filed 10–3–17; 8:45 am]
                                                  years; phase I would begin in the fall of               and operating rules adopted by the                    BILLING CODE 4120–01–P




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Document Created: 2018-10-25 09:56:05
Document Modified: 2018-10-25 09:56:05
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionWithdrawal of proposed rule.
DatesAs of October 4, 2017, the proposed rule published January 12, 2017, at 82 FR 3678, is withdrawn.
ContactJohn Spiegel, (410) 786-1909.
FR Citation82 FR 46181 
RIN Number0938-AR84

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