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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

New California Law Turns Up the Heat on the Sunshine Act: California Physicians and Surgeons Must Provide Notice to Patients About...

Effective January 1, 2023, California Assembly Bill 1278 requires California-licensed physicians and surgeons, including physicians and surgeons licensed under the Medical Practice Act or the Osteopathic Act (but excluding...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

Forecasting Healthcare Regulatory Developments in a Biden Administration

President Joe Biden was sworn into office on January 20, 2021. As with any incoming administration, new policies will be pursued while those of the previous administration are furthered, abandoned, or undone. The federal...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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