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 September 30, 2023

Judge refuses to block Medicare drug negotiation program

A judge just refused to put a stop to the Medicare Drug Price Negotiation program, much to the dismay of some Democrats as well as the pharmaceutical industry.

CNBC reports that, on Friday, Judge Michael Newman, of the Southern District of Ohio, refused to grant the preliminary injunction against the program that had been requested by the Chamber of Commerce lobbying group.

The group was trying to stop the program from going into effect before Oct. 1, which, according to CNBC, "is the deadline for manufacturers of the first 10 drugs selected for negotiations to agree to participate in the talks."

As the Centers for Medicare and Medicaid Services (CMS) explain on their website, the Medicare Drug Price Negotiation program allows Medicare "to negotiate directly with drug companies to improve access to some of the costliest single-source brand-name Medicare Part B and Part D drugs."

These negotiations, as stated, are scheduled to begin in the near future, namely, October 2023. The negotiations will continue through the rest of 2023 and through 2024.

The prices of different drugs will be negotiated at different times.

The first round of negotiations will regard the drugs: Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica, Stelara, and Fiasp. Also considered will be some other insulins made by Novo Nordisk, including NovoLog.

The prices reached for the drugs through the negotiations would not be expected to take effect until 2026, at the earliest.

But, before the program gets that far, it is going to have to survive some legal challenges.

One of these legal challenges has come from the Chamber of Commerce lobbying group. The group brought the lawsuit against the administration of President Joe Biden back in June.

The group has argued that the program violates the First and Fifth Amendments of the U.S. Constitution. The group also claims that the program violates the Constitution's separation of powers principle.

But, Judge Newman, a Trump nominee, disagrees. In his 18-page order, declining the injunction request, he wrote:

As to Plaintiffs' motion for a preliminary injunction, they have demonstrated neither a strong likelihood of success nor irreparable harm. Consequently, their request for immediate preliminary injunctive denied.

At the same time, though, Newman also refused to dismiss the lawsuit, meaning that, for now, both the program and the lawsuit will proceed.

Newman has given the lobbying group until Oct. 13 to amend its complaint, and he has given the Biden administration until Oct. 27 to renew its motion to dismiss.

Written By:
Oliver Winters

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