publication date: Dec. 11, 2020

Cancer and industry groups file legal challenges to administration’s MFN rule

By Paul Goldberg

Pharmaceutical and biotechnology industry groups, joined by cancer groups, filed legal challenges to an HHS rule that uses international reference prices to lower Medicare Part B prices.

The Most Favored Nation Rule, published by the Trump administration Nov. 20, would place a large number of cancer drugs out of reach of Medicare patients, critics say (The Cancer Letter, Dec. 4, 2020).

Critics also point out that countries that enjoy MFN status with the U.S. have very different drug development, approval, supply, and pricing systems.

One of the legal challenges was filed by the Pharmaceutical Research and Manufacturers of America in conjunction with the Association of Community Cancer Centers, the Global Colon Cancer Association, and the National Infusion Center Association. The lawsuit, filed in U.S. District Court for the District of Maryland, is available here.

Another suit was filed by the Biotechnology Innovation Organization, the California Life Sciences Association, and BIOCOM California. The complaint, filed in the U.S. District Court for the Northern District of California is available here.

The Community Oncology Alliance is expected to file a separate suit Dec. 11.

The complaint, spearheaded by PhRMA, seeks an injunction on enforcement of the MFN Interim Final Rule and a declaration that the rule is unconstitutional and invalid.

The allegations center on three areas:

The administration has exceeded the authority granted to the Center for Medicare & Medicaid Innovation under the Affordable Care Act;

The administration has violated the U.S. Constitution by using a regulatory process to rewrite the Medicare statute and transform the reimbursement system … Continue reading Cancer and industry groups file legal challenges to administration’s MFN rule

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