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BioWorld - Monday, March 16, 2026
Home » Topics » Regulatory » CMS

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U.S. White House

White House moves on telehealth executive order to counter rural hospital closure

Aug. 4, 2020
By Mark McCarty
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.
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Telehealth illustration

Support for telehealth growing, but privacy still a sticking point

July 13, 2020
By Mark McCarty
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.
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Product image

COVID-19, BLM push diabetes equity, access issues as experts assess tech use after ADA

July 7, 2020
By Stacy Lawrence
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.
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Product image

CMS steers closer to coverage of secondary mitral regurgitation in draft coverage rewrite

July 1, 2020
By Mark McCarty
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.
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CMS begins to tear down the wall to value-based Rx pricing

June 18, 2020
By Mari Serebrov
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.
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Medicare puzzle

NTAP eligibility for Sentinel, Aquabeam devices set to expire for Medicare NTAP program

May 29, 2020
By Mark McCarty
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
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Drugs-insulin2

Manufacturers to foot much of the bill for Medicare insulin savings

May 26, 2020
By Mari Serebrov
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.
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2-24-Viz-AI.png

Medicare NTAP no tap dance for some new technologies, pricing models

May 18, 2020
By Mari Serebrov
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.
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Laptop, stethoscope, medical icons, health professional

CMS, ONC offer enforcement discretion for EHR rules

April 24, 2020
By Mark McCarty
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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Laptop, stethoscope, medical icons, health professional

CMS, ONC offer enforcement discretion for EHR rules

April 23, 2020
By Mark McCarty
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. The term of the delays of compliance for several of these rules is not uniform, ranging from “late 2020” to “spring 2021,” and vendors thus will have to be vigilant to ensure they do not cross any compliance tripwires.
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