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HHS Names the First 10 Drugs for Medicare Price Negotiation

Listening Sessions on Drug Price Negotiations Will Be Live Streamed and Opened to the Public This Fall - In this Alert, we provide an update regarding the first 10 drugs for Medicare price negotiation selected under the...more

2022-2023 Medical Product and Service Regulatory Initiatives

The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more

New Reimbursement Rules Will Likely Impact Digital Health and Telemedicine

On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued the 2023 Physician Fee Schedule (PFS) Final Rule. CMS publishes a PFS annually so as to make changes in federal healthcare reimbursement and...more

Prescription Drug Provisions in the Inflation Reduction Act of 2022

The Inflation Reduction Act of 2022 (the Act) includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, such as allowing the U.S. Department of Health...more

CMS Proposes Basic Changes for Medicare Coverage, Including a New Reimbursement Pathway for FDA-designated Breakthrough Medical...

On August 31, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that, if finalized, would entail changes in Medicare coverage. (“Medicare Coverage of Innovative Technology (MCIT) and Definition...more

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