“Nothing to see here” seems to be the general reaction to the four executive orders President Donald Trump signed Friday in an effort to reduce U.S. prescription drug prices. Two of the orders – one on importing drugs from Canada and the other on kicking the safe harbor out from under the rebates pharmacy benefit managers (PBMs) get from drug companies – instruct Health and Human Services (HHS) to continue, or resume, rulemaking on those measures.
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.
The Medicare coverage memo for next-generation DNA sequencing (NGS) was reopened to allow for NGS testing for other than late-stage cancers, but stakeholders are urging the U.S. Centers for Medicare and Medicaid Services (CMS) to allow repeat testing, another change that would considerably boost utilization.
Advocates of telehealth are backing the bipartisan, bicameral Connect for Health Act of 2019, which would eliminate geographic and origination site restrictions on Medicare coverage and save billions of taxpayer dollars.
Despite a substantial build-up of expectations, the U.S. federal government has excluded device makers from a proposal to provide safe harbors under the anti-kickback statutes for value-based arrangements between providers and medical device makers. The news comes as a blow to device makers, who have argued for some time that value-based arrangements between industry and hospitals could save the taxpayer millions each year in Medicare spending, but the draft rule made note of concern that such arrangements might reduce competition among device makers.
Whether it's mere political posturing or a genuine prescription to control U.S. drug prices, a Democratic plan taking shape in the House provides an idea of what direct government negotiation might look like.
Faced with a tradeoff between low Medicare premiums that benefit all beneficiaries and lower out-of-pocket costs that benefit the sickest beneficiaries, the Trump administration chose lower premiums, sinking a proposed rule that would have pulled drug rebates from the safe antikickback harbor.
Once upon a time in the days before enlightenment, we tried to use science to develop our drugs. Believe it or not, researchers actually had to come up with a hypothesis of how a drug might work, what disease it might tackle and who it might work for – before testing it in a crayon box of humans. In the early days, the focus was on drugs that worked for the average patient. In their rush to develop these drugs, sponsors were exclusive, almost elitist – some would say even discriminatory – in the patients they allowed in their clinical...
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