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U.S. House passes drug pricing legislation

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...

News

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...

News

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...

News

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...

News

Life sciences and health care horizons 2021

Companies in the life sciences and health care industry navigated unparalleled challenges in 2020. The pandemic forced the development and adoption of new technologies and innovations...

News

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 ...

News

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...

Hogan Lovells Publications

Election 2020 Snapshot: Helping our clients make sense of the U.S. election results

On Tuesday, November 3, 2020, Americans chose the presidency and the makeup of the United States Congress.

News

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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