The separate “pass-through” payment Medicare provides for new, high-cost Part B drugs that are part of certain hospital procedures in the U.S. may be an incentive for hospitals to use those drugs rather than less expensive alternatives, according to a new Government Accountability Office (GAO) report.
The Medicare Part D rebate rule finalized by the Trump administration last November could be in limbo for a while. As it did with other so-called midnight rules issued in the waning days of the Trump presidency, the U.S. Department of Health and Human Services, under the Biden administration, is postponing the implementation of the rule, which was intended to simplify the U.S. drug pricing system by eliminating the rebates drug makers pay to pharmacy benefit managers for formulary placement or requiring plans to pass the discounts directly to patients.
The U.S. pathway for legally importing certain prescription drugs from Canada to take advantage of lower prices is closer to opening for business with the FDA issuing a final rule and guidance on making it happen.
“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.
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