The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), both as part of the Department of Health and Human Services, and hereinafter also referred...

Apr 8, 2022 · Ensuring the availability of innovative interventions for people is a shared priority for both the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA).

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the...

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.

After the FDA has determined that a product can be brought to market, CMS must determine whether Medicare and Medicaid should cover and pay for it. This policy brief lays out practical, bipartisan, and achievable steps for FDA and CMS to improve their collaboration with each other and with stakeholders.

Dec 4, 2024 · Today, the Biden-Harris Administration announced that two drug manufacturers with Food and Drug Administration-approved gene therapies for sickle cell disease have entered into agreements with the Centers for Medicare & Medicaid Services (CMS) to participate in the Cell and Gene Therapy Access Model.

Jan 18, 2024 · CMS regulates laboratories that perform testing on individuals in the U.S. through the Clinical Laboratory Improvement Amendments of 1988 (CLIA) by establishing quality standards for all...

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, 2024 · Through the evaluation of information submitted to the agency, including clinical trial data, the Food and Drug Administration (FDA) ensures that drugs are “safe and effective” and that biologics meet the standard of “safety, purity, and potency.”

Importance When the US Food and Drug Administration (FDA) approves a drug or medical device on the basis of limited clinical evidence, the Centers for Medicare & Medicaid Services (CMS) must decide whether the therapy is “reasonable and necessary” for coverage among Medicare beneficiaries. However, the legal underpinnings of CMS’s ...