Notice2022-22296
Establishment of the Medicare Drug Rebate and Negotiations Group Within the Center for Medicare (CM)
Primary source
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Published
October 14, 2022
Effective
October 8, 2022
Issuing agencies
Health and Human Services Department
Abstract
Establish the Medicare Drug Rebate and Negotiations Group within the Center for Medicare (CM) to implement the Drug Price Negotiation Program and the Inflation Rebate Program in Medicare Part B and Part D as authorized under the Inflation Reduction Act of 2022. CMS is responsible for implementing these new programs.
Full Text
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<title>Federal Register, Volume 87 Issue 198 (Friday, October 14, 2022)</title>
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[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Page 62433]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-22296]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Establishment of the Medicare Drug Rebate and Negotiations Group
Within the Center for Medicare (CM)
AGENCY: Centers for Medicare & Medicaid Services, HHS.
SUMMARY: Establish the Medicare Drug Rebate and Negotiations Group
within the Center for Medicare (CM) to implement the Drug Price
Negotiation Program and the Inflation Rebate Program in Medicare Part B
and Part D as authorized under the Inflation Reduction Act of 2022. CMS
is responsible for implementing these new programs.
DATES: This reorganization was approved by the Secretary of Health and
Human Services and takes effect October 8, 2022.
SUPPLEMENTARY INFORMATION: Statement of Organization, Functions, and
Delegations of Authority Part F of the Statement of Organization,
Functions, and Delegations of Authority for the Department of Health
and Human Services, Centers for Medicare & Medicaid Services (CMS)
(last amended at Federal Register, Vol. 75, No. 56, pp. 14176-14178,
dated March 24, 2010; Vol. 76, No. 203, pp. 65197-65199, dated October
20, 2011; Vol. 78, No. 86, p. 26051, dated May 3, 2013; Vol. 79, No. 2,
pp. 397-398, dated January 3, 2014; and Vol. 84, No. 32, p. 4470, dated
February 15, 2019) is amended to reflect the establishment of the
Medicare Drug Rebate and Negotiations Group within the Center for
Medicare (CM) to implement the Drug Price Negotiation Program and the
Inflation Rebate Program in Medicare Part B and Part D as authorized
under the Inflation Reduction Act of 2022. CMS is responsible for
implementing these new programs.
Title I, Subtitle B, Part 1, sections 11001-11004, of the Inflation
Reduction Act of 2022 (IRA) Public Law 117-169 enacted on August 16,
2022, establishes a new Drug Price Negotiation Program under Medicare
Part B and Medicare Part D to lower prices for certain high-spend
single source drugs. Title I, Subtitle B, sections 11101 and 11102 of
the IRA also enacts a new program to establish Inflation Rebates in
Medicare Part B and Medicare Part D. CMS is responsible for
implementing these new programs.
The work required to implement and administer these new programs
will be novel and differ significantly from the Medicare functions that
CMS performs today. Given the unique nature of this new work, there is
not an existing operating component, group, office or division in CMS
or CM that performs these actions. Moreover, the scope and complexity
of these new programs, and the deadlines for implementation, require
that a new, dedicated organization be established to ensure that CMS is
able to implement these programs successfully and on time. In order to
implement and operate these new programs, CMS is creating a new group--
the Medicare Drug Rebate and Negotiations Group--within CM.
Part F, Section FC. 10 (Organization) is revised as follows:
Center for Medicare, Medicare Drug Rebate and Negotiations Group
Part F, Section FC. 20 (Functions) for the new organization is as
follows:
Medicare Drug Rebate and Negotiations Group
With regard to the Drug Price Negotiation Program, each year, the
new group will negotiate drug prices with pharmaceutical manufacturers
for certain Part B and Part D drugs. This will require identifying
negotiation-eligible drugs, entering into agreements with
manufacturers, collecting extensive data from manufacturers and other
sources, calculating ceiling and maximum fair prices, negotiating
prices with manufacturers, re-negotiating prices as necessary and
publishing the results of the negotiation. Under the Inflation Rebate
Program, manufacturers of certain drugs will be required to pay a
penalty or ``rebate'' if the price of their drug increases faster than
the rate of inflation. For this program, the new group will need to
identify the universe of rebatable drugs under Part B and Part D;
determine which drugs had price increases in excess of inflation; and
compute, invoice, and collect rebates owed by manufacturers.
To carry out these functions, the major tasks of the new group will
include:
<bullet> Developing policy, including identifying and vetting
policy options and preparing policy memoranda, rulemaking and technical
guidance;
<bullet> Briefing policy officials in CMS, U.S. Department of
Health and Human Services (HHS), and Executive Office of the President
(EOP);
<bullet> Establishing operational processes to collect data from
manufacturers and other sources;
<bullet> Conducting pharmacoeconomic analyses and assessments of
selected drugs;
<bullet> Establishing operational processes to negotiate and re-
negotiate drug prices and conducting those negotiations with
manufacturers;
<bullet> Establishing operational processes to calculate and
invoice rebates;
<bullet> Developing contractual agreements with manufacturers
necessary to effectuate both programs;
<bullet> Monitoring manufacturer compliance with programmatic
rules;
<bullet> Procuring and managing contractors to support these
functions;
<bullet> Conducting stakeholder outreach and educational materials;
and
<bullet> Responding to inquiries from Congress, the press, and
other external stakeholders.
Authority: 44 U.S.C. 3101.
Dated: October 7, 2022.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-22296 Filed 10-12-22; 4:15 pm]
BILLING CODE 4120-01-P
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