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BioWorld - Wednesday, February 4, 2026
Home » Topics » Regulatory » CMS

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CMS OKs coverage for Pq Bypass TORUS 2 study

Dec. 20, 2019
By Meg Bryant
Pq Bypass Inc., of Milpitas, Calif., said that the Centers for Medicare and Medicaid Services (CMS) has agreed to cover its TORUS 2 investigational device exemption (IDE) clinical trial, which is evaluating the Torus stent graft in the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA).
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Abbott-MITRACLIP-12-16.png

Doctors ink mitral valve repair guidelines as CMS eyes Mitraclip coverage

Dec. 16, 2019
By Mark McCarty
While the U.S. Centers for Medicare and Medicaid Services (CMS) revisits its coverage policy for transcatheter mitral valve repair devices, several physician societies have drafted recommendations for operator and institutional volume requirements that could restrict the number of centers authorized to practice devices such as Abbott Park, Ill.-based Abbott Laboratories’ Mitraclip.
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U.S. health spending rises to $3.6T in 2018, but falls as share of GDP

Dec. 6, 2019
By Mark McCarty
Policymakers are often as sensitive to overall health care spending as they are to increases in Medicare spending, and the latest report on both brought some good news and some bad news. The good news is that overall health care spending was essentially flat as a share of gross domestic product (GDP) in 2018, but the bad news is that Medicare spending jumped 6.4%, thus renewing the troublesome historical trend of outpacing typical GDP growth.
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Patients to payers: Can you hear me now?

Nov. 22, 2019
By Mari Serebrov
Patient engagement has become more than a buzzword for the FDA and drug and device developers. But for payers, not so much. When valuing new drugs and devices, payers often undervalue or ignore what they may consider convenience updates, giving little to no consideration to the difference a seemingly minor improvement could make to patients debilitated by fatigue, pain, the burden of treatment and the burden of a disease itself.
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CMS backs away from rate cuts for PET in CY 2020 doc fee final

Nov. 6, 2019
By Mark McCarty
The U.S. Centers for Medicare and Medicaid Services (CMS) has decided against a series of rate cuts for PET imaging in the Medicare physician fee schedule for 2020, a move lauded by physicians who were facing a rate cut of as much as 80% for nuclear medicine and molecular imaging procedures.
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CMS drops references to late-stage cancers in draft rewrite of NGS coverage memo

Oct. 31, 2019
By Mark McCarty
The U.S. Centers for Medicare and Medicaid Services (CMS) has posted a draft rewrite of the coverage memo for next-generation sequencing (NGS), and while the draft rewrite fails to address a number of concerns, the agency eliminated references to advance-stage cancer, opening the door to considerably greater utilization.
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Bipartisan group of legislators push back on cuts to PET imaging

Oct. 7, 2019
By Mark McCarty
A bipartisan group of 43 members of the U.S. House of Representatives has inked a letter to the U.S. Centers for Medicare and Medicaid Services (CMS), objecting to planned Medicare cuts for myocardial positron emission tomography (PET) imaging. The letter argues that the proposed rate cut of 72% would hamper access to a procedure that is typically provided in physician offices – and puts the onus on the CMS to justify the rate cut.
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Trump promises quicker Medicare coverage for breakthrough technologies

Oct. 4, 2019
By Mari Serebrov

Advamed urges CMS to form Medicare advisory panel for digital health

Oct. 3, 2019
By Mark McCarty
Medicare coverage of digital health is evolving, but there are those who have argued that the U.S. Centers for Medicare and Medicaid Services (CMS) is moving too slowly to capitalize on significant opportunities. The Advanced Medical Technology Association (Advamed) said in comments to the docket for the draft physician fee schedule that an advisory panel should be regularly convened in order to exploit the potential for digital health to "transform the delivery of care and improve patient care outcomes."
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MDMA cites class effect for safety in comments to Medicare outpatient draft

Oct. 1, 2019
By Mark McCarty
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