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The Genesis case: The beginning of the end of HRSA’s “patient” definition?

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

CMS Proposes Significant Changes to Medicaid Drug Rebate Program

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

HHS OIG issues ASP reports exploring need for guidance and increased oversight in ASP reporting

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

Inflation Reduction Act’s Medicare Part D benefit redesign explained

In the third of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Ken Choe and Melissa Bianchi discussed the Medicare Part D redesign and answered questions from...more

Inflation Reduction Act’s Medicare Part B and D inflation rebates explained

In the second of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Alice Valder Curran and Ken Choe, as well as David Chan, President and General Manager of...more

Inflation Reduction Act’s Drug Price Negotiation Program explained

In the first of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Alice Valder Curran and Ken Choe discussed the Drug Price Negotiation Program established by...more

Senate Passes Drug Pricing Legislation

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

D.C. District Court rules for PhRMA in PBM accumulator programs Final Rule litigation

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

Trump Administration revives rebate safe harbor rule in late effort to reform drug pricing

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...more

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