Stuart Langbein

Aug 14, 2024 | jdsupra.com | James Huang |Stuart Langbein |Rianna Modi

August 14, 2024 James Huang, Stuart Langbein, Rianna Modi, Beth Roberts, Victoria Wallace Hogan Lovells + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: On August 7, 2024, the Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET) (Final Notice).

Aug 14, 2024 | lexology.com | Stuart Langbein |Beth Roberts |James Huang |Victoria Wallace |Rianna Modi

On August 7, 2024, the Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET) (Final Notice). The long-anticipated Final Notice on the TCET pathway finalizes a new mechanism to provide Medicare patients with more timely and predictable access to certain Food and Drug Administration (FDA) designated Breakthrough devices.

Jul 29, 2024 | lexology.com | Alice Valder Curran |Ken Choe |Stuart Langbein |Kathleen Peterson |Samantha Marshall |Mahmud Brifkani | +2 more

The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers.

Jul 3, 2024 | jdsupra.com | Elizabeth Halpern |James Huang |Stuart Langbein

July 3, 2024 Elizabeth Halpern, James Huang, Stuart Langbein, Rianna Modi, Beth Roberts, Victoria Wallace Hogan Lovells + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: On June 27, 2024, the Ensuring Access to Breakthrough Products Act of 2024 (H.R. 1691) was marked up and reported out of the House Ways and Means Committee.

Jun 28, 2023 | jdsupra.com | Elizabeth Halpern |Stuart Langbein |Beth Roberts

Stakeholders may submit comments to the Notice during the comment period, which will end on August 28, 2023. According to a CMS Fact Sheet on TCET, CMS will respond to comments in a final notice. Eligibility to participate in TCETAs proposed, the TCET pathway would facilitate coverage only for devices that have Breakthrough designation from the FDA.