Both brand-name and generic drugs must be approved by the Food and Drug Administration (FDA) before they can be prescribed to people. Brand-name drugs are marketed under exclusive, trademark-protected names and are protected by patents.

We examined approaches to improve coordination between the FDA and Centers for Medicare and Medicaid Services (CMS) for drugs granted accelerated approval. We argue that policymakers have focused on expedited pathways at the FDA without sufficient attention to complementary policies at the CMS.

Medicare-approved private plans offer this coverage. Even if you don’t take prescription drugs now, consider getting Medicare drug coverage. All plans must cover a wide range of prescription drugs that people with Medicare take, including most drugs in certain protected classes, like drugs to treat cancer, HIV/AIDS, or depression.

Aug 4, 2023 · FDA indicates US Food and Drug Administration. Among 64 analyzed technologies that required establishment of new Medicare coverage, the time spent seeking a coverage milestone varied from less than 91 days to about 7 years.

Aug 29, 2023 · The increasing number of drugs granted accelerated approval by the Food and Drug Administration (FDA) has challenged the Medicare program, which often pays for expensive therapies despite substantial uncertainty about benefits and risks to Medicare beneficiaries.

Medicare drug coverage (also known as Medicare Part D) helps pay for the brand-name and generic drugs you need. It's optional and offered to everyone with Medicare by insurance companies and other private companies approved by Medicare. Even if you don’t take prescription drugs now, ...

Jul 6, 2023 · Broader Medicare coverage is now available for Biogen and Eisai’s Leqembi (the brand name for lecanemab) following the Food and Drug Administration’s (FDA) move to grant traditional approval to the drug that treats individuals with Alzheimer’s disease.

Better coordination between the FDA and CMS could improve the transparency and predictability of drug approval and coverage around accelerated-approval drugs, with important implications for patient outcomes, health spending, and evidence generation processes.

Jan 29, 2025 · Rachel Sachs and Richard G. Frank identify key questions and policy options for CMS and the Medicare drug renegotiation process. ... exclusivities recognized by the Food and Drug Administration ...

The Food and Drug Administration (FDA) defines a medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: • Recognized in the official National Formulary, or the United States Pharmacopoeia,