Teva received an appellate court ruling suggesting that CMS did not have authority from Congress to define a bona fide marketing standard for its IRA Medicare Fair Price negotiations. How does this relate to products targeted for IPAY negotiations and biosimilar competitors? This week, Teva received an appellate court ruling on the IRA Medicare Fair … Continue reading The Bona Fide Marketing Standard and What That Means for Biosimilars and Generics
Tag: CMS
New CMS Proposal Lowers Cost Sharing for Part D Biosimilars and Follow-on Biologics
CMS treats biosimilars as generics for the purposes of the part D coverage gap. It now wants to ensure that biosimilars are treated as generics in terms of the coverage gap for only those receiving low-income subsidies.
Additional Thoughts on CMS’s Changes to Biosimilar Part B Coding
The biosimilar news articles of the last week have included more data and announcements from the American College of Rheumatology on clinical outcomes of biosimilars to the reference product, debates over their prescription and utility of interchangeability, and of course, and frustration over the delays in biosimilars reaching the market caused by patent litigation. As … Continue reading Additional Thoughts on CMS’s Changes to Biosimilar Part B Coding
CMS Makes Major Policy Change to Biosimilar HCPCS Coding
Currently, all biosimilars for the same reference product are given the same temporary Q code, while the reference product retains its J code. CMS has decided to change course and assign each biosimilar its own Q code.
Biosimilar Industry Group Urges Congress to Address Part B Reimbursement
Reimbursement of biosimilars for Medicare Part B beneficiaries has long been an issue for biosimilar manufacturers.