In this episode of the Diagnosing Health Care Podcast: From wholesale revisions of the merger guidelines to significant amendments to the Hart-Scott-Rodino premerger notification forms, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) have proposed significant changes that, if adopted, will have profound effects on merger review and enforcement for the foreseeable future.
What might these changes mean for hospitals, health systems, and other stakeholders in the health care industry?
On this episode, Epstein Becker Green attorneys Trish ...
On August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the ten (10) Medicare Part D drugs selected for the first round of negotiations of the Medicare Drug Price Negotiation Program (Program)—a few days before the September 1, 2023, statutory deadline imposed by the Inflation Reduction Act (IRA). The negotiated pricing will go into effect in 2026.
In its announcement, CMS included details about upcoming opportunities for public input regarding the Program, including a series of patient-focused listening sessions CMS plans to hold for each ...
On March 15, the Centers for Medicare and Medicaid Services (CMS) released guidance on the drug price negotiations provisions of the Inflation Reduction Act (IRA). The guidance contains CMS’s interpretations for a range of elements in the drug price negotiation process, including the manufacturer specific data elements that it will review in potential adjusting its view of the appropriate price.
While other data elements also deserve manufacturers’ attention, CMS’s approach to accounting for manufacturer costs associated with research, development and manufacturing will have profound implications for biopharmaceutical manufacturers. The agency’s proposed factors omit substantial investments while improperly treating others as sunk costs. As innovators prepare to comment on CMS’s guidance, they will want to convey the need for more fulsome consideration of these investments in the upcoming negotiations.
Blog Editors
Recent Updates
- Podcast: Telehealth Post-Public Health Emergency – What to Expect in 2024 – Diagnosing Health Care
- Unpacking Averages: Analyzing FDA Device-Related Citizens Petitions by Topic
- Warning - Transaction Delays Expected. State Notice Requirements Ahead for Health Care M&A!
- New York Aims to Bolster Hospital Cybersecurity with Imminent Release of Proposed Regulations
- Sharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft Guidance