Real-world evidence (RWE) and clinical trial data might seem to bear little resemblance to each other, but Naomi Aronson, executive director for clinical evaluation at the Blue Cross and Blue Shield Association, said there are problems common to both. The most significant of these is an absence of validated outcomes measures for many conditions, measures Aronson said are “desperately” needed in order to make an appropriate coverage determination.
The Trump administration has issued an executive order designed to improve access to telehealth for Medicare beneficiaries in rural America, making permanent numerous changes that had been temporarily added for the COVID-19 pandemic. The news arrives as the Centers for Medicare and Medicaid Services (CMS) posted the draft Medicare physician fee schedule (MPFS) complete with expanded use of telehealth for a number of services.
If there’s a readily visible upside to the COVID-19 pandemic, it may be that telehealth is not only much more accessible, it’s also supremely topical among policymakers. However, privacy concerns are still a significant source of drag in some respects, a consideration that extends to digital medicine as well in the context of contact tracing used to corral the SARS-CoV-2 virus.
After the recent conclusion of the American Diabetes Association (ADA) Scientific Sessions, virtual diabetes management company Onduo LLC held an event with the ADA and diabetes researchers to discuss how technology can help to bridge that gap to empower more diabetes patients.
The U.S. Centers for Medicare and Medicaid Services (CMS) posted the much-anticipated draft do-over of the mitral valve repair device coverage memo, and in the process renamed the policy the mitral valve transcatheter edge-to-edge repair (TEER) national coverage memo.
After 30 years of following the same rules to ensure Medicaid receives the lowest price available for prescription drugs, the U.S. Centers for Medicare & Medicaid Services (CMS) is starting to adapt those rules for the 21st century.
The Medicare inpatient draft is always an event due to its impact on medical technology. Now, several products soon may see their new technology add-on payments (NTAP) expire because of eligibility. The Centers for Medicare and Medicaid Services (CMS) said both Claret Medical Inc.’s Sentinel embolic protection device and Procept Biorobotics Corp.’s Aquabeam device have used up their NTAP eligibility, and hospitals may see lower rates for using those devices starting Oct. 1
Unpredictable and unaffordable copays for insulin could be a thing of the past for millions of people enrolled in certain Medicare Part D prescription drug plans.
Except for breakthrough devices and qualifying infectious disease drugs, the footwork for getting Medicare's new technology add-on payment (NTAP) can be more challenging than that needed to win FDA approval. It could be even tougher for products that use artificial intelligence (AI) or that follow a subscription model for pricing.
The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic.
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