2021-11160: 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

Summary

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.

The agency’s own summary, as published.

What this changes

Amends 4 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 42 CFR 433 State Fiscal Administration
• 42 CFR 438 Managed Care
• 42 CFR 447 Payments for Services
• 42 CFR 456 Utilization Control