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Expedited breakthrough device coverage, “reasonable and necessary” definition delayed until Dec. 15

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...

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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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CMS delays “reasonable and necessary” definition, expedited breakthrough device coverage process rule

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...

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CMS finalizes “reasonable and necessary” definition, expedited breakthrough device coverage process

On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) published a final rule that, for the first time, adopts a regulatory standard for determining whether a ...

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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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Medicare links Part B payment rates to international prices: Most Favored Nation Model

On November 20, 2020, the U.S. Centers for Medicare & Medicaid Services (CMS) issued an interim final rule (IFR) with comment period implementing a mandatory “Most Favored...

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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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