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Home » Topics » Regulatory » CMS

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Regulatory front

Merit Medical agrees to $18M fine in qui tam case

Oct. 15, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Federal Circuit declines to overturn lower court ruling for Medtronic; FDA stands pat on biotin interference threshold in final guidance; CMS adds to telehealth list.
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Regulatory front

FDA posts draft for biocompatibility updates

Oct. 14, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA taking adcomm nominations; HHS, DoD ink deal with Cue Health; NTAP town hall set for Dec. 15-16.
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Regulatory front

Medicare imaging stakeholders urge waiver of budget neutrality for MPFS

Oct. 13, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG: Medicare overpaid for facet-joint injections; FDA posts IIE policy for non-COVID tests.
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Regulatory front

Stakeholders sound off on Medicare doc fee, outpatient drafts

Oct. 6, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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U.S. flag, stethoscope
Virtual Medtech Conference

CMS’s Jensen says FDA, CMS collaboration will expand with MCIT program

Oct. 5, 2020
By Mark McCarty
Device makers have wondered in the past whether they like the idea of the Centers for Medicare & Medicaid Services (CMS) peering over the U.S. FDA’s shoulders in premarket applications, which might be a concern as well for the Medicare program for coverage of breakthrough devices. Tamara Syrek Jensen, director of the Coverage and Analysis Group at CMS, declined to say whether her office has any influence over what would be designated as a breakthrough device by FDA, stating little more than that “we will constantly be talking with the FDA” about breakthrough devices.
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Medicare puzzle

MedPAC eyes deflation, bundling as solutions to high-end testing under lab fee schedule

Oct. 1, 2020
By Mark McCarty
The Medicare clinical lab fee schedule (CLFS) in the U.S. has gone through some twists and convolutions in connection with the rate reset effort, but the suite of expensive, high-end tests is another source of spending concern. The Medicare Payment Advisory Commission (MedPAC) examined that question recently and is considering several possible solutions. Among these are a fixed-rate deflation metric from a starting price point and bundling with a provider’s bundled payment program, two possible solutions that each carry their own set of headaches.
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Colorful illustration of the heart

CMS draws heat for proposal to eliminate national coverage for artificial hearts

Sep. 25, 2020
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) recently proposed some changes to national coverage policies for left ventricular assist devices (LVADs) and artificial hearts, the latter of which would no longer be covered under a national coverage determination. The proposal to allow Medicare administrative contractors (MAC) to make coverage decisions for artificial hearts on a case-by-case basis clanged across both industry and medical societies, which cited data collection problems and inequalities in access as reasons the existing coverage policy should remain in place.
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U.S. flag, stethoscope

CMS’s Jensen emphasizes definition of ‘reasonable and necessary’ in MCIT draft

Sep. 23, 2020
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) has posted a proposed rule for coverage of FDA-designated breakthrough devices, a programmatic objective that has been front and center for the agency for several years. However, Tamara Syrek Jensen, director of the Coverage and Analysis Group (CAG) at CMS, said the proposal to redefine the term “reasonable and necessary” may be the more critical piece of the proposed rule because it would give the agency unprecedented flexibility in covering a broad swath of medical technologies.
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Product image

Registry played a role in Watchman experience, but approval for device iteration still aspirational

Sep. 15, 2020
By Mark McCarty
The U.S. FDA has been easing gently down the road of real-world evidence (RWE) in regulatory decision-making, and the case of the Watchman left atrial appendage device is instructive in this regard. Robert Shipley, of Boston Scientific Corp. (BSX), said on webinar hosted by the Advanced Medical Technology Association that the FDA changed gears and agreed to a registry for a post-approval study for the first generation Watchman, but added that the use of registry data and other RWE for approval of a next-generation device is as yet more aspirational than practicable.
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U.S. flag and money

Advamed: NTAP term of eligibility stuck at three years in absence of pandemic override

Sep. 11, 2020
By Mark McCarty
Don May, Advamed’s executive vice president for payment and health care policy, said on a Sept. 11 press briefing that any device that misses its first year of new technology add-on payment (NTAP) eligibility may not be able to recover that year unless CMS makes an exception for the pandemic, seemingly leaving the Boston Scientific Eluvia device with only two years of eligibility for its NTAP application.
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