The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a couple of years emerge.
Just as it is for terminally ill cancer patients, time is of the essence for people in the early stages of Alzheimer’s disease. Thus, the clinical meaningfulness of Eli Lilly and Co.’s donanemab is the time it gives patients before the disease progresses, Reisa Sperling, a neurology professor at Harvard Medical School and director of the Center for Alzheimer’s Research and Treatment at Brigham and Women’s Hospital, told the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee June 10.
Just as it is for terminally ill cancer patients, time is of the essence for people in the early stages of Alzheimer’s disease. Thus, the clinical meaningfulness of Eli Lilly and Co.’s donanemab is the time it gives patients before the disease progresses, Reisa Sperling, a neurology professor at Harvard Medical School and director of the Center for Alzheimer’s Research and Treatment at Brigham and Women’s Hospital, told the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee June 10.
New York-based Cleerly Labs Inc., petitioned several U.S. Medicare administrative contractors for coverage of the use of the company’s artificial intelligence product for analysis of CT coronary arteries to evaluate the disease burden of plaque.
U.S. Medicare coverage of products for leg and foot ulcers has undergone a second review in less than a year thanks to pushback from stakeholders after the August 2023 issuance of proposed non-coverage policies for more than 100 cell and tissue-based products.
One of the problems with the European Union’s Artificial Intelligence Act is that it spans all sectors of the E.U. economy, an approach that Sen. Bill Cassidy (R-La.) suggested is less than optimal in remarks to this year’s meeting of the Medical Device Manufacturers Association. Nonetheless, Cassidy said some in the Senate are keen to pass legislation without taking proper stock of the lack of congressional expertise, which runs the risk that hasty legislation may create more problems than it solves.
In finalizing its 2025 Medicare Advantage and Part D rule, the U.S. Centers for Medicare & Medicaid Services (CMS) all but did away with the coverage differences between biosimilars and interchangeables.
When it comes to whether Medicare Part D should cover the new anti-obesity drugs, the U.S. Centers for Medicare & Medicaid Services and lawmakers may be caught between the math and public pressure.
Medicare coverage of medical software in the U.S. is generally not the subject of flattering remarks from industry, but the novelty of the subcategory of artificial intelligence (AI) would seem to suggest that the Medicare problem for AI is even more severe. That suspicion was borne out by consultant Bruce Quinn who said at a public meeting here in Washington that some areas of software coverage and reimbursement, including AI software, “are just a train wreck,” a problem he said is especially acute in fee-for-service care.
Wegovy (semaglutide) has racked up another indication. The U.S. FDA approved the injectable for reducing risk of major adverse cardiovascular events such as death, heart attack or stroke and for long-term weight management. The approval expands the drug’s potential. The mighty glucagon-like peptide 1 receptor agonist from Novo Nordisk A/S was already approved for those age 12 and older who are obese and for some overweight adults with weight-related problems.
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