FDA

Medicare Coverage of Alzheimer’s Drugs Relies on FDA Traditional Approval

June 5, 2023 - The Centers for Medicare and Medicaid Services (CMS) has announced that it will provide Medicare coverage for new Alzheimer’s drugs if they receive traditional approval from the Food and Drug Administration (FDA). “Alzheimer’s disease takes a toll on not just the people suffering from the disease but also on their loved ones and...


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CMS Releases Alzheimer’s Treatment National Coverage Determination

by Kelsey Waddill

CMS has finalized its national coverage determination for monoclonal antibodies directed against amyloid, a new potential treatment for Alzheimer’s disease. The agency moved forward with its...

Step Therapy Protocols Vary By Health Plan, 55% Too Strict

by Kelsey Waddill

For certain diseases, some payers implement step therapy protocols that are stricter than clinical and regulatory entities have recommended, researchers found in a Health Affairs study. “Step...

Medicare Covers COVID-19 Booster for Immunocompromised Americans

by Kelsey Waddill

CMS has announced that immunocompromised individuals will receive the coronavirus booster shot without cost-sharing. On August 12, 2021, the Food and Drug Administration (FDA) recommended a booster...

CMS Rule Aims to Accelerate Medicare Coverage of Breakthrough Tech

by Kelsey Waddill

CMS has issued a final rule entitled Medicare Coverage of Innovative Technology (MCIT) that aims to accelerate Medicare coverage of technological innovations. “Government processes have slowed...

CareFirst Announces COVID-19 Vaccine Coverage for All Members

by Kelsey Waddill

CareFirst BlueCross BlueShield (CareFirst) has announced that it would offer coronavirus vaccine coverage for all coronavirus vaccines for members, including self-insured members. “The health...

Payers Recommend Actions To Promote Biosimilars, Drug Competition

by Kelsey Waddill

The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) can streamline the biosimilar approval process and adopt other strategies to promote biosimilars and lower healthcare spending,...

Proposed Bill Permits HHS to Negotiate Drug Prices, Saves $345 B

by Kelsey Waddill

By allowing the HHS to negotiate drug prices tied to international standards, Title I of the Lower Drug Costs Now Act of 2019 (HR-3) would save the federal government $345 billion from 2023 to 2029,...

Employers Coalition Takes Up Drug Price Transparency, Price Caps

by Kelsey Waddill

When it comes to lowering skyrocketing drug prices, employers are making their voices heard on drug price transparency, drug price increase caps, and other price reducing strategies through the...