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Ramping up the drug pricing debate: Dueling bills and paying for health care infrastructure

The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the reintroduced Republican-led H.R. 19, the “Lower...

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No Surprises Act prohibits balance billing, creates arbitration process for out-of-network providers

Effective January 1, 2022, the “No Surprises Act” signed into U.S. law as part of H.R. 133, “Consolidated Appropriations Act, 2021,” implicates (1) emergency...

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2020 final price reporting developments: stimulus legislation, 340B contract pharmacy Advisory Opinion

As we begin the new year, we wanted to highlight two final developments from December 2020:First, on Dec. 27, 2020, the stimulus legislation H.R. 133, the Consolidated Appropriations Act...

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MDRP: CMS Final Rule on value-based purchasing, line extension definition, PBM accumulator programs

On December 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule (link) that materially modifies current Medicaid Drug Rebate Program (MDRP) regulations,...

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340B Program: HRSA Issues Administrative Dispute Resolution Final Rule

On December 14, 2020, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register defining an administrative dispute resolution (ADR) ...

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Trump administration reversal would take away FDA’s authority to approve biosimilars

On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions ...

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Medicaid Drug Rebate Program proposed rule on value-based pricing, line extension, PBM accumulators

On June 17, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Proposed Rule (link) that would materially modify current Medicaid Drug Rebate Program (MDRP) regulations....

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Medicaid Drug Rebate Program: CMS addresses authorized generics, drug category narrow exception

The Centers for Medicare & Medicaid Services (CMS) recently issued two manufacturer releases. The first provides further information regarding the treatment of sales of authorized...

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Medicaid Drug Rebate Program: CMS addresses authorized generics, drug category narrow exception in manufacturer releases 112 and 113

The Centers for Medicare & Medicaid Services (CMS) recently issued two manufacturer releases. The first provides further information regarding the treatment of sales of authorized...

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