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Courts Block Implementing Most Favored Drug Pricing Rule


Tuesday, December 29, 2020
On 23 December 2020, Judge Catherine Blake of the U.S. District Court for the District of Maryland granted the Pharmaceutical Research and Manufacturers of America (PhRMA) a 14-day nationwide temporary restraining order, preventing the Centers for Medicare and Medicaid Services (CMS) from implementing and enforcing its Most Favored Nation (MFN) interim final rule (MFN Rule) scheduled to take effect on 1 January 2021.
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On 28 December 2020, in a parallel case and specifically adopting the reasoning in Judge Blake’s order, Judge Vince Chhabria of the U.S. District Court for the Northern District of California granted California Life Sciences Association (CSLA) a preliminary injunction prohibiting CMS from implementing the MFN Rule based on a failure to follow notice and comment procedures under Administrative Procedure Act (APA). Most notably, Judge Chhabria’s order vacates the MFN Rule in its entirety pending completion of the no ....

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PhRMA is granted temporary injunction against favored nation rule


PhRMA is granted temporary injunction against favored nation rule 
The American Hospital Association is also against the rule that was to have gone into effect on January 1, 2021. 
, Managing Editor
Today Judge Catherine Blake of the U.S. District Court for the District of Maryland granted PhRMA and others a temporary restraining order regarding the administration s most favored nation rule that was supposed to go into effect on January 1, 2021.
The move pleased both PhRMA and the American Hospital Association. 
Hospitals and health systems have very deep concerns about the substance and legality of this model, and the AHA filed a Declaration with this lawsuit expressing how the model could negatively impact hospitals, health systems and the patients they care for, said AHA executive vice president Tom Nickels. ....

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Trump's 'Most-Favored Nation' Rule On Drug Prices Blocked


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Trump s Most-Favored Nation Rule On Drug Prices Blocked
Law360 (December 23, 2020, 8:23 PM EST) A Maryland federal judge on Wednesday blocked a recent Trump administration rule that links Medicare reimbursement for dozens of drugs to lower prices paid in other countries, finding that the government rushed to finalize the rule without providing a public comment period.
U.S. District Judge Catherine C. Blake granted the temporary restraining order brought by the Association of Community Cancer Centers, the National Infusion Center Association, the Global Colon Cancer Association and Pharmaceutical Research and Manufacturers of America, saying the Administrative Procedure Act requires the government to publish a notice and provide a public comment period before promulgation of a final. ....

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Medicare Part B Most Favored Nation Drug Pricing Model: New Rules, New Lawsuits, New Tweets | Sheppard Mullin Richter & Hampton LLP


[co-author: Ariana Stobaugh ]
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). ....

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