On April 15, 2025, the White House issued an Executive Order (EO) entitled “Lowering Drug Prices by Once Again Putting Americans First.” The EO directs various agencies to engage in a number of distinct efforts to lower...more
On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act...more
On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program....more
The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more
On May 3, 2024, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the IRA. Notwithstanding the...more
On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative dispute resolution (ADR) process...more
On April 2, 2024, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Notice of Benefit and Payment Parameters (NBPP) final rule (Final Rule), finalizing policies applicable to qualified health plans offered...more
On December 14, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “revised” guidance documents implementing the Medicare Part B and Part D inflation rebate provisions of the Inflation Reduction Act of...more
On November 3, 2023, the U.S. District Court for the District of South Carolina issued a decision granting in large part Genesis Health Care’s (Genesis’s) motion for summary judgment in its litigation against the Health...more
On July 3, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its final guidance on the Drug Price Negotiation Program established by the IRA. CMS showed some willingness to adopt stakeholder suggestions...more
On May 23, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program...more
On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction Act (IRA) on August 16, 2022. The Drug...more
On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “initial” guidance documents implementing the Medicare Part B and Part D inflation rebate provisions of the Inflation Reduction Act of 2022...more
On January 3, 2023, the Department of Health and Human Services Office of Inspector General (OIG) publicly released two reports with respect to Medicare Part B average sales price (ASP)....more
On November 30, 2022, the Health Resources and Services Administration (HRSA) published a proposed rule (Proposed Rule) in the Federal Register that proposes to introduce several changes to the current administrative dispute...more
On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant drug pricing-related provisions. The bill generally revives many of the drug pricing provisions...more
On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s motion for summary judgment and vacating (i.e.,...more
On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s motion for summary judgment and vacating (i.e.,...more
Last week, the Centers for Medicare & Medicaid Services (CMS) issued Manufacture Release 116, available here, which provides technical guidance to manufacturers on the multiple best prices (BPs) reporting option for...more
While Congress continues to consider significant drug pricing legislation, separate regulatory and statutory changes have been finalized this week with potential implications for manufacturers that report prices into the...more
This morning, the U.S. House passed drug pricing legislation as part of the Build Back Better Act (BBBA) (specifically the Rules Committee version available here and the manager’s amendments available here). In prelude to...more
On October 13, 2021, the in-person portion of the annual informaconnect Medicaid Drug Rebate Program (MDRP) Conference concluded in New Brunswick, New Jersey. A day earlier, on October 12, 2021, a joint hearing was held in...more
10/19/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On May 14, 2021, the Centers for Medicare & Medicaid Services (CMS) released a display copy of a Final Rule (Final Rule) further delaying the effective date of the Medicare Coverage of Innovative Technology (MCIT) and...more
The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the Republican-led H.R. 19, the “Lower Costs, More Cures Act of 2021” and a reintroduced...more
4/26/2021
/ Biden Administration ,
Critical Infrastructure Sectors ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part D ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda
On March 17, 2021, the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register delaying the effective date of the final rule titled, “Medicare Program; Medicare Coverage of Innovative...more