United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2021_register
executive
2021-05-28
article
Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements: Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States
Proposed Rules
D09002ee1ae4e49e4
D09002ee1ae4e4a65
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Centers for Medicare & Medicaid Services
originator
org
United States Government Agency or Subagency
This proposed rule proposes to delay for 6 months the January 1, 2022 effective date for amendatory instruction 10.a., which addresses the reporting by manufacturers of multiple best prices connected to a value based purchasing arrangement, of the final rule entitled, ``Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements'', published in the December 31, 2020 Federal Register. This proposed rule also proposes to delay for 2 years the April 1, 2022 effective date of inclusion (inclusion date) for U.S. territories (American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands) in the amended regulatory definitions of ``States'' and ``United States'' for purposes of the Medicaid Drug Rebate Program (MDRP), adopted in the interim final rule with comment period entitled, ``Medicaid Program; Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of States and United States'', published in the November 25, 2019 Federal Register to April 1, 2024. In the alternative, we are proposing to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received. We are requesting public comment on the proposed delays of applicable effective date and inclusion date discussed in greater detail below.
86 FR 28742
https://www.govinfo.gov/app/details/FR-2021-05-28/2021-11160
2021-11160
fr28my21-19
RIN 0938-AT82
4120-01-P
CMS-2482-P2
https://www.govinfo.gov/app/details/FR-2021-05-28/2021-11160
https://www.govinfo.gov/content/pkg/FR-2021-05-28/html/2021-11160.htm
https://www.govinfo.gov/content/pkg/FR-2021-05-28/pdf/2021-11160.pdf
Accounting
Administrative Practice and Procedure
Drugs
Grant Programs-Health
Health Facilities
Health Professions
Medicaid
Reporting and Recordkeeping Requirements
Rural Areas
5 p.
28742
28746
86 FR 28742
Code of Federal Regulations
Title 42 Part 433
42 CFR Part 433
Code of Federal Regulations
Title 42 Part 438
42 CFR Part 438
Code of Federal Regulations
Title 42 Part 447
42 CFR Part 447
Code of Federal Regulations
Title 42 Part 456
42 CFR Part 456
Regulation Identification Number 0938-AT82
RIN 0938-AT82
Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements: Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States; Federal Register Vol. 86, Issue
PRORULE
2021-11160
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
2021-06-28
CMS-2482-P2
4120-01-P
2021-11160
Proposed rule.
This proposed rule proposes to delay for 6 months the January 1, 2022 effective date for amendatory instruction 10.a., which addresses the reporting by manufacturers of multiple best prices connected to a value based purchasing arrangement, of the final rule entitled, ``Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements'', published in the December 31, 2020 Federal Register. This proposed rule also proposes to delay for 2 years the April 1, 2022 effective date of inclusion (inclusion date) for U.S. territories (American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands) in the amended regulatory definitions of ``States'' and ``United States'' for purposes of the Medicaid Drug Rebate Program (MDRP), adopted in the interim final rule with comment period entitled, ``Medicaid Program; Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of States and United States'', published in the November 25, 2019 Federal Register to April 1, 2024. In the alternative, we are proposing to finalize an inclusion date that may be earlier than April 1, 2024, but not before January 1, 2023, based on public comments received. We are requesting public comment on the proposed delays of applicable effective date and inclusion date discussed in greater detail below.
To be assured consideration, comments on the proposals must be received at one of the addresses provided below by June 28, 2021.
Christine Hinds, (410) 786-4578; Wendy Tuttle, (410) 786-8690.
Accounting
Administrative Practice and Procedure
Drugs
Grant Programs-Health
Health Facilities
Health Professions
Medicaid
Reporting and Recordkeeping Requirements
Rural Areas
Medicaid Program:
Establishing Minimum Standards in Medicaid State Drug Utilization Review and Supporting Value-Based Purchasing for Drugs Covered in Medicaid, etc.; Delays of Effective and Inclusion Dates,
http://www.regulations.gov
https://www.cms.gov/files/document/covid-pandemic-plan.pdf
https://www.federalregister.gov/documents/2020/12/31/2020-28567/medicaid-program-establishing-minimum-standards-in-medicaid-state-drug-utilization-review-dur-and
Regulations.gov
Federal Register
Vol. 86, no. 102
Office of the Federal Register, National Archives and Records Administration
2021-05-28
continuing
daily
deposited
born digital
493 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2021-05-28
P0b002ee1ae4e3d1b
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr28my21
https://www.govinfo.gov/app/details/FR-2021-05-28
https://www.govinfo.gov/content/pkg/FR-2021-05-28/pdf/FR-2021-05-28.pdf
https://www.govinfo.gov/content/pkg/FR-2021-05-28/xml/FR-2021-05-28.xml
fdlp
28687
29171
DGPO
2021-05-28
2021-05-28
FR-2021-05-28
machine generated
eng
FR
FR-2021-05-28
86
102