Brian Carey

2 months ago | jdsupra.com | Brian Carey |Elizabeth Halpern |James Huang

BackgroundMedicare generally only covers or items that are “reasonable and necessary” for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. When CMS issues an NCD establishing whether an item or service is covered by Medicare, it must evaluate clinical, medical, technical, and scientific evidence to determine if the item or service satisfies this reasonable and necessary standard.

May 13, 2024 | jdsupra.com | Brian Carey |Samuel B. Hoff |Ross Margulies

Key Takeaways: The Department of Health and Human Services Office of Inspector General (OIG) has issued a long-awaited, favorable advisory opinion regarding certain single-donor rare disease state patient assistance funds operated by an independent charity. In an unprecedent move, OIG set a time limit for the advisory opinion, terminating it two years after the full implementation of the Medicare Part D benefit redesign established through the Inflation Reduction Act of 2022 (IRA).

Mar 28, 2024 | jdsupra.com | Patrick Brennan |Brian Carey |Sarah Cooleybeck

Key Takeaways: Bipartisan legislation moving through the U.S. House and Senate, known as the BIOSECURE Act, could limit the ability of U.S. life sciences companies to contract with biotechnology companies with ties to the Chinese government or another “foreign adversary.” The potentially broad scope of the legislation would both prohibit the U.S. government from contracting with a “biotechnology company of concern,” as well as prevent companies that contract with or receive funding from the...

Dec 11, 2023 | jdsupra.com | Thomas Barker |Brian Carey |Erin Estey Hertzog

Key Takeaways: The draft framework represents the most significant formal step taken by any Administration toward the exercise of march-in rights over patents of inventions made with federally funded research since the enactment of the Bayh-Dole Act in 1980.

Feb 17, 2023 | jdsupra.com | Brian Carey |Erin Estey Hertzog

Key Takeaways: On February 7, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published a report outlining administrative challenges the Centers for Medicare & Medicaid Services (CMS) may encounter in implementing and operationalizing the Part B inflation rebates, together with solutions to these challenges.