FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Each phase-in program requires the manufacturer to have had a Coverage Gap Discount Program agreement in effect in 2021, and only covers applicable drugs that have been in the market as of August 16, 2022 (i.e., had Part D expenditures on or before August 16, 2022).

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Labelling Drug Pricing Compounding Payment Processing 105

Putting Patients First Blog

NOVEMBER 14, 2023

When pharmacies are compelled to hold onto funds for extended periods as part of the retrospective payment process, it can strain their financial resources, potentially leading to difficulties in maintaining sufficient medication supplies, thereby disrupting patient access. JAMA Network Open, 2(4) , doi: 10.1001/jamanetworkopen.2019.2606

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Drug Pricing Specialty Pharmacies HIPAA Payment Processing 40

Putting Patients First Blog

JULY 2, 2024

When pharmacies are compelled to hold onto funds for extended periods as part of the retrospective payment process, it can strain their financial resources, potentially leading to difficulties in maintaining sufficient medication supplies and disrupting patient access. 2022 AMA prior authorization (PA) physician survey.

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Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52