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Colorado PDAB First In Nation To Consider UPL For A Drug

Colorado’s prescription drug affordability board (PDAB) voted unanimously Friday (Feb. 23) to consider establishing an upper payment limit on Amgen’s psoriasis and arthritis drug Enbrel, and if the board follows through it would be the first in the nation to establish an upper payment limit for a drug.

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Paragon Echoes Community Plans’ Recs In New Suite Of MA Reforms

Paragon Health Institute has joined the ranks of stakeholders pushing for major overhauls to the Medicare Advantage program in a new report saying changes to benchmarking, risk adjustment, star ratings and alignment of MA with fee-for-service Medicare could save the program $250 billion over 10 years.

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Ahead of oral arguments in the Supreme Court case over the abortion pill mifepristone, the anti-abortion physician plaintiffs in the case are again arguing that FDA’s move in 2021 to allow the drug to be prescribed via telehealth violates the 1870 Comstock Act, providing a potential pathway for the justices to restrict access to the drug despite the plaintiffs’ weak case for standing.

CMS says it was following Congress’ instructions when it decided to finalize all its proposed changes to the Medicaid Disproportionate Share Hospital allocations despite the tens of millions of dollars the rule is expected to slash from some hospitals’ finances.

Ahead of FDA’s annual Rare Disease Day event March 1, the House Energy & Commerce Committee will hold a legislative hearing to consider 18 bills aimed at assisting patients with rare diseases, including legislation reauthorizing FDA’s pediatric rare disease priority review voucher and expanding the number of orphan drugs excluded from the Inflation Reduction Act’s (IRA) Medicare drug price negotiation program.

FDA is strongly urging device makers to use accredited third parties recognized by the agency to ensure their pre-market submissions don’t include falsified test results, pointing to growing concerns that fabricated data from unaccredited third parties in China and India are showing up in device applications.

Colorado’s prescription drug affordability board (PDAB) voted unanimously Friday (Feb. 23) to consider establishing an upper payment limit on Amgen’s psoriasis and arthritis drug Enbrel, and if the board follows through it would be the first in the nation to establish an upper payment limit for a drug.

House and Senate Democrats Thursday (Feb. 22) wrote to AHIP and United Health Group to demand insurers comply with the Affordable Care Act’s requirement to cover all FDA-approved contraceptives without cost-sharing, specifically urging the companies to immediately adopt the “therapeutic equivalent standard” the administration outlined in guidance issued Jan. 22.

Democrats on the House Energy & Commerce Committee are taking FDA to task for missing a deadline to release legally mandated guidance on diversity action plans for pivotal clinical trials, a provision that was included in the Food and Drug Omnibus Reform Act of 2022 (FDORA).