PHARMA: Biden Freezes Trump’s Lower Cost Insulin and Epinephrine Rule
Posted on 01/22/2021
Big pharma is smiling big right now. The big three insulin producers are Eli Lilly and Company, Novo Nordisk A/S, and Sanofi S.A., in which they dominate more than 90% of the world insulin market by value. After swearing-in, U.S. President Joe Biden’s HHS froze the Trump administration’s December 2020 drug policy that mandates community health centers to pass on all their insulin and epinephrine discount savings to patients.
The rule was finalized in late December 2020. The drug rule was put in place to benefit patients who have a hard time paying for expensive insulin and allergy medication. Former President Trump campaigned on lowering the price of important pharmaceutical drugs like insulin, which is used to treat diabetes, and epinephrine. Diabetes afflicts over a quarter of Medicare beneficiaries and drives billions in Medicare spending every year. More than 20 million Americans
Federal District Courts Enjoin CMS’s Most Favored Nation Model Rule for Medicare Part B Drug Reimbursement Saturday, January 9, 2021
At a time when prescription drug costs have been increasingly burdensome for Medicare beneficiaries, and the American taxpayer, the Centers for Medicare and Medicaid Services (“CMS”) issued an interim final rule with comment period on November 27, 2020,[i] explicitly recognizing, as a basis for the rule, “[i]ncreases in drug prices” that “far exceed prices in other countries.”[ii] and establishing a new reimbursement methodology for the payment of selected drugs under Part B of the Medicare program.[iii]
The new rule implements the “Most Favored Nation Model” (“MFN Rule” or “Model Rule”) which sought to link drug costs under Medicare Part B for 50 high-cost drugs to the lowest price of a non-U.S. member country of the Organization for Economic Co-operation and Development.[iv] The expectation was that the MF
email article
WASHINGTON The fate of the Trump administration s most favored nation (MFN) rule for bringing down prescription drug prices remains uncertain as President-elect Joe Biden prepares to assume office later this month.
On Sept. 13, 2020, President Trump signed an executive order saying that the Department of Health and Human Services would test payment models for Medicare Parts B and D in which Medicare would pay for certain drugs not more than the most favored nation price, defined as the lowest price, after adjusting for volume and differences in national gross domestic product, for a pharmaceutical product that the drug manufacturer sells in a member country of the Organisation for Economic Co-operation and Development that has a comparable per-capita gross domestic product.
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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 notice and com