- Posts by Richard H. Hughes IVMember of the Firm
Richard Hughes is a multi-talented health lawyer, strategic advisor, advocate, and teacher.
His thought leadership and problem-solving strategies have broken barriers to access for vaccines and medicines. His advice on legal ...
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.
In its recent decision in U.S. House of Representatives v. Burwell, the U.S. District Court for the District of Columbia ruled that the Obama administration's payment of cost-sharing subsidies for enrollees in plans offered through the Affordable Care Act's Exchanges is unauthorized for lack of Congressional appropriation. The decision would affect future cost-sharing subsidies, though the court immediately stayed the decision pending its outcome on appeal.
In its decision, the court found in favor of the members of the House of Representatives, based upon its ...
2016 is poised to be a major year in network adequacy developments across public and private insurance markets. Changes are ahead in the Medicare and Medicaid managed care programs, the Exchange markets and the state-regulated group and individual markets, including state-run Exchanges. The developing standards and enforcement will vary significantly across these markets.
Through 2014 and 2015, major news stories discussed concerns over the growing use of narrow provider networks by issuers on the Affordable Care Act's insurance exchanges ("Exchanges"). Others reported on ...
- DOJ’s FY 2023 Statistics: Highest Number of Settlements, Judgments, and Civil Investigative Demands in History and a Continued Health Care Focus
- FDA Releases Updated Directory on Select Dietary Supplement Ingredients
- In Alabama, Pre-Embryos are “Extrauterine Children” Under the State’s Wrongful Death Statute
- NJ Approves Cannabis Regulatory Amendment with Major Impacts on Class 5 Retail License Holders
- Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not Disproportionately Hurting Minorities