The U.S. Centers for Medicare & Medicaid Services (CMS) had covered transcarotid artery revascularization for patients at high risk of poor outcomes during carotid artery endarterectomy to correct for stenosis, but the agency recently expanded that patient population to those at standard surgical risk. The news was lauded by the Society for Vascular Surgery (SVS) as a solid development for patients, given that this procedure’s complication rates are in many instances lower than seen in conventional endarterectomy.
The U.S. Centers for Medicare & Medicaid Services’ (CMS) decision last month restricting coverage of a class of Alzheimer’s drugs to clinical trials meeting the agency’s standards still isn’t sitting well with some lawmakers.
The U.S. CMS has suspended the effective date of the radiation oncology (RO) model for bundled care under the Medicare outpatient prospective payment system. The development stems from congressional legislation that pushed the start date back until next year, giving stakeholders who are opposed to the program more time to press their case with Congress and the agency.
Bringing a new medical device or diagnostic to market has never been a small feat for small companies, and regulatory review is still one of the largest hurdles facing device makers. However, a new report by Boston Consulting Group (BCG) and the UCLA Biodesign program shows that the twin issues of coverage and reimbursement still combine to present the most difficult hurdle to overcome for med-tech companies.
While the Medicare Coverage of Innovative Technologies (MCIT) program has been formally abandoned, the U.S. CMS has resurrected those policy underpinnings in the form of the Transitional Coverage for Emerging Technologies (TCET) concept. Several speakers on a recent webinar said the TCET paradigm should allow CMS to promptly rescind coverage in the event of a safety signal, including Mark McClellan, who has served as both FDA commissioner and CMS administrator.
Most of the better-known targets of prosecution under the U.S. False Claims Act (FCA) are drug and device manufacturers, but the Department of Justice (DOJ) seems to have opened a new front in the war on Medicare fraud.
The U.S. CMS has expanded the population of Medicare beneficiaries who are eligible for lung cancer screening via low-dose CT (LDCT) imaging. The news drew raves from stakeholders who also lauded the expansion of the facilities that can conduct the procedure, constituting a set of changes that advocates say will save thousands of additional lives.
Developers of apps for digital health have struggled to obtain Medicare coverage in the U.S. for their products, an impasse that seems unlikely to resolve anytime soon. Jason Bennett of CMS said on a Feb. 9 webinar that while the durable medical equipment (DME) benefit category seems like a natural fit for digital health products, there are some statutory and definitional roadblocks, including that digital health products might not be durable enough to qualify.
Despite mandating earlier this year that private health insurance plans make over-the-counter COVID tests free to their subscribers, the U.S. CMS took until Feb. 3 to make the same benefit available to Medicare beneficiaries. The problem is that these tests will not be available to Medicare beneficiaries free of charge until “early spring,” the agency said, a point in time by which the latest surge of the pandemic is likely to have dissipated.
The process of reauthorizing critical U.S. FDA user fee agreements (UFAs) for drugs, generics and biosimilars took its first step forward in Congress Feb. 3 as the House Energy & Commerce Subcommittee on Health dipped its feet into the new enhancements included in the agreements the FDA negotiated with stakeholders over the past two years.
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