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Citing the First Amendment, the Fifth Amendment and the logic of fair play, Pfizer Inc. is taking on a Health and Human Services’ (HHS) antitrust policy that prohibits drug companies from helping Medicare beneficiaries with hefty copays.
Except for breakthrough devices and qualifying infectious disease drugs, the footwork for getting Medicare's new technology add-on payment (NTAP) can be more challenging than that needed to win FDA approval. It could be even tougher for products that use artificial intelligence (AI) or that follow a subscription model for pricing.
Heartflow Inc., of Redwood City, Calif., is working on two Medicare administrative contractors (MACs) to cover its functional flow reserve algorithm for the coronary arteries, but Heartflow’s Heather Brown told BioWorld that said that the existing local coverage policies fall far short of the cost of the service, thus impeding beneficiary access.
