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.
A renewed focus on telehealth and telemedicine may be pumping new life into remote patient monitoring for heart failure, which seems to be the case for the Cardiomems device by Abbott Inc.
U.S. Medicare coverage of transcatheter aortic valve replacement devices requires the use of team medicine for patient selection purposes, which seems to have served as a tripwire for Cape Cod Hospital (CCH) in Hyannis, Mass. Federal agencies forged an agreement with CCH that included a $24 million fine for failure to appropriately screen patients for the procedure, an event that serves as a reminder that non-compliance with Medicare rules can trigger enforcement actions by other agencies.
The U.S. Centers for Medicare and Medicaid Services (CMS) is rethinking its proposed “stacking rule” for determining best price in the Medicaid program.
With round 1 not yet completed, the U.S. Centers for Medicare & Medicaid Services (CMS) already is prepping for round 2 of the Medicare negotiations mandated by the 2022 Inflation Reduction Act. While the negotiation process will expand to Part B drugs in the future, round 2, like the first cycle, will be limited to single-source Part D drugs that account for some of the highest Medicare expenditures. However, the number of drugs selected for the next cycle could grow from the current 10 to up to 15
The U.S. government chalked up another win April 29 against the constitutional challenges to the Inflation Reduction Act’s provision mandating direct Medicare price negotiations for selected prescription drugs.
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.
After investing $24 billion in three major acquisitions earlier this year, Bristol Myers Squibb Co. said April 25 it would cut 2,200 employees and discontinue 12 programs in an effort to save $1.5 billion and put the company on track for growth by the end of the decade. The number of jobs lost represent 28% of all biopharma jobs lost so far in 2024 – 7,834, as announced by 82 companies. There were 17,424 jobs lost at 185 companies in 2023 and 18,500 jobs lost at 123 companies in 2022, according to BioWorld data.
Having addressed the manufacturing issues that resulted in a few complete response letters, Alvotech Holdings SA and Teva Pharmaceutical Industries Ltd.’s biosimilars partnership is now on a roll, with the U.S. FDA approving the team’s second biosimilar, Selarsdi, less than two months after approving the first one, Simlandi, as an adalimumab interchangeable.
Telehealth received a much-needed boost from the COVID-19 pandemic, but normal reality has settled in and a number of telehealth bills have surfaced in the U.S. House of Representatives. However, Rep. Brett Guthrie (R-Ky.) advised other members of the House that a recent extension of temporary Medicare telehealth coverage added $2 billion to Medicare spending, a fact which he said forces legislators to ensure that “whatever we move out of committee is paid for.”
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