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.”
Some gene therapies could be big winners under the changes the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing to Medicare’s new technology add-on program (NTAP) for its fiscal 2025 inpatient prospective payment system.
In the inpatient draft for fiscal 2025, the U.S. Centers for Medicare & Medicaid Services has proposed an accountable care model for beneficiaries on fee-for-service care, one which is designed to provide the coordination of care ordinarily seen only in accountable care organizations.
The U.S. Centers for Medicare & Medicaid Services has proposed a few significant changes to the new technology add-on program for the fiscal year 2025 inpatient prospective payment system, including a boost in NTAP rates for gene therapy services.
With credit card fees taking a sizable bite of their billings, many U.S. health care providers are fighting back by offering patients cash discounts. But when a drug company covers card processing fees for its distributors to pass on to their provider clients so they can pay for so-called “buy-and-bill” Medicare Part B drugs with a credit card at cash prices, it’s fraud if those concessions aren’t figured into the drug’s average sales price – at least that’s what the U.S. Department of Justice is claiming in a complaint it released April 10 against Regeneron Pharmaceuticals Inc.
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