Monday, December 21, 2020
On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment models – one model for prescription drugs covered by Part B of the Medicare program (in general terms, Medicare Part B covers drugs that are administered by infusion or injection in physician offices and hospital outpatient departments, as well as certain drugs furnished by suppliers), and a second model for prescription drugs covered by Part D of the Medicare program (Medicare Part D covers most medications that are dispensed by local and/or mail-order pharmacies and covered under a Medicare prescription drug plan).
Prospects Dim for Medicare Drug Reimbursement Cuts medscape.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medscape.com Daily Mail and Mail on Sunday newspapers.
PhRMA and others file injunction to stop favored nation rule from taking effect on January 1, 2021 American Hospital Association is among the providers against the rule that would cut drug reimbursement.
, Managing Editor
The Pharmaceutical Research and Manufacturers of America, the Association of Community Cancer Centers, the Global Colon Cancer Association and National Infusion Center Association have filed a motion for a temporary restraining order and preliminary injunction to stop the Most Favored Nation rule from taking effect on January 1, 2021.
The motion and accompanying memorandum of law filed on Thursday assert that, because the rule would cause immediate and irreparable harm, the court should halt implementation.
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As we previously reported, in July 2019 the U.S. Department of Health and Human Services (HHS) announced a Safe Importation Action Plan (Action Plan) created with the FDA to allow the importation of certain prescription drugs originally intended for foreign markets, and particularly Canada. In the fall, the Trump administration announced implementation of the Action Plan (the “Final Rule”,
see 85 Fed. Reg. 62,094 (Oct. 1, 2020)). In response, on November 27, days before the Final Rule was to go into effect, Canadian Health Minister Patty Hadju signed an order to limit bulk exports of prescription drugs if they would create a shortage at home. Hadju stated that “[c]ompanies will now also be required to provide information to assess existing or potential shortages, when requested, and within 24 hours if there is a serious or imminent health risk.”