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Cost Sharing Program In Part D From Coalition Of Cancer Drug Manufacturers Rebuffed By OIG

 
• By Cathy Kelly

Federal watchdog group acknowledges proposed assistance program aligns with comments in a 2005 OIG advisory bulletin on patient assistance programs in Medicare Part D, but maintains the bulletin should not serve as a roadmap for a compliant program in this case.

Program Would Cover 90% Of Oncology Drug Use In Part D • Source: Shutterstock

A proposed cost sharing assistance program for oncology drugs in Medicare Part D that would be funded by a coalition of manufacturers and administered by an intermediary “would generate prohibited remuneration if the requisite intent were present, which would constitute grounds for the imposition of sanctions” under the federal anti-kickback statute, the US Health and Human Services Department’s Office of Inspector General concluded in an advisory opinion posted on 5 October.

The OIG said it is not in a position to evaluate the program sponsors’ intent because that is beyond the scope of the advisory opinion process. As a result, “we cannot reach a definitive conclusion regarding the existence of a federal anti-kickback statute violation in this opinion

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More from Compliance

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

More from Pink Sheet

Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.

EMA Explores Using AI Language Models To Refine Oncology Guidance

 
• By Vibha Sharma

The European Medicines Agency has for the first time explicitly stated it is considering the use of large language models as a tool to improve the readability of a scientific guideline.

Industry On Making England’s HTA Innovation Lab A Success

 
• By Eliza Slawther

England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.