The Medicare Wasteful and Inappropriate Service Reduction (WISeR) proposal is designed to tamp down on waste, fraud and abuse in the Medicare program, but Jeff Wurzberg, a partner at Norton Rose Fulbright LLP, told BioWorld that the contractors developing these AI models have incentives to return non-covered determinations for services.
Hailing it as a win-win and a historic step forward in fighting chronic disease, the Trump administration announced pricing agreements Nov. 6 with Eli Lilly and Co. and Novo Nordisk A/S that will expand the availability of the companies’ weight loss drugs by cutting prices and, for the first time, providing coverage for the drugs in obesity through Medicare and Medicaid.
The U.S. CMS has confirmed that it will cover renal denervation as a treatment for hypertension in a final coverage memo that largely mirrors the July 2025 draft. One key difference, however, is that Medicare beneficiaries are eligible for RDN after only six weeks of optimized medical therapy, half the three-month waiting period described in the draft.
Impulse Dynamics Inc. snared an affirmative Medicare coverage policy for its Optimizer cardiac contractility modulation (CCM) system, giving the company sole possession of the U.S. marketplace for this therapy at least for the time being.
The U.S. CMS has adopted an aggressive payment policy for skin substitutes in the Medicare physician fee schedule for 2026, although the payment rate is sufficiently higher than the agency had proposed to mollify some critics.
The Office of Inspector General (OIG) said in a new report that the U.S. Medicare program had overpaid a group of providers of durable medical equipment (DME) by nearly $23 million between 2018 and 2024, an amount that is a significant drop from prior years, but which OIG said calls for further reforms for the Medicare DME program.
John Crowley doesn’t worry about where his kids’ toys are made, but he told the Senate Health, Education, Labor and Pensions Committee that he does care where their medicines are made. His concerns, as a father and as president/CEO of the Biotechnology Innovation Organization, are becoming more urgent, he testified at an Oct. 29 HELP hearing on the future of biotech in the U.S.
Caught between the rock and the hard place of most-favored nation (MFN) pricing and the threat of a hefty biopharma sector tariff, drug companies marketing in the U.S. are exploring their options. Several large firms already have committed millions and billions of dollars in investment in new or expanded U.S.-based manufacturing facilities to avoid tariffs on finished drugs.
Government and market demands on companies and their pricing strategies have shifted dramatically in the past 10 years and the pricing landscape continues to change, creating uncertain ground beneath developers’ feet. At the BioFuture conference in New York, a panel discussed how big and small companies go about their pricing strategies and build educated guesses into how that strategy might work out in the market.
Like the federal district court before it, the U.S. Court of Appeals for the Third Circuit said it lacks jurisdiction to rule on the merits of Novo Nordisk A/S’ claim that the CMS violated the Inflation Reduction Act (IRA) when it treated six of the company’s insulin aspart products as one negotiation-eligible single-source drug.
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