From its inception the 340B program has been the subject of disputes between drug manufacturers and their safety-net hospital customers. On August 12 HHS proposed an administrative process for resolving those disputes. Established in 1992, the 340B program requires manufacturers to enter into pharmaceutical …
Bill Would Extend CMPs to Federal Grants
July 7, 2015 Leave a Comment
The bill known as the “21st Century Cures,” H.R.6, would extend Civil Monetary Penalties (CMPs) to cover false claims and false statements relating to grants, contracts, and other agreements funded by the Department of Health & Human Services (HHS). Falsehoods relating to clinical trials appear to be a …
HHS RELABELS INVALIDATED 340B REGULATION AS “INTERPRETATIVE RULE”
July 23, 2014 Leave a Comment
Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted its long-held position on its website, this time calling it an “interpretative …
HHS POISED FOR ROUND TWO OF ORPHAN DRUG FIGHT
June 16, 2014 Leave a Comment
HHS isn’t ready to throw in the towel in the fight over expansion of the 340B program under the Affordable Care Act (ACA). On Thursday HHS said in a court filing that it will appeal last month’s federal court ruling that struck down a regulation issued by the Health Resources & Services …
AHA SUES HHS OVER TWO-MIDNIGHT RULE
April 15, 2014 Leave a Comment
Somebody had to do it—sue HHS to overturn the much-maligned two-midnight rule. So, yesterday the American Hospital Association, joined by several other high-profile hospital organizations, filed a lawsuit against HHS Secretary Katherine Sebelius (no wonder she’s resigning) to prevent enforcement of the …