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Home » Topics » Regulatory » CMS

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U.S. Capitol building, Washington D.C.

House members pushing MCIT as Cures 2.0 awaits committee action

Nov. 24, 2021
By Mark McCarty
A number of members of the U.S. House of Representatives have penned a letter to the Centers for Medicare & Medicaid Services (CMS) in support of the Medicare Coverage of Innovative Technology (MCIT) rule, the second time in recent weeks the agency has heard from Congress. The net effect of these letters is to suggest that Cures 2.0, which would provide Medicare coverage of breakthrough devices, is not on solid footing, which if true would suggest that the Biden administration’s Advanced Research Projects Agency for Health (ARPA-H) is similarly endangered.
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U.S. flag and money

Follow-up legislation to US 21st Century Cures Act reintroduced

Nov. 16, 2021
By Mark McCarty

Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) have reintroduced Cures 2.0, legislation they said will increase access to live-saving cures and treatments for a variety of diseases such as Alzheimer’s disease.


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U.S. flag, stethoscope

CMS puts final nail in the MCIT coffin

Nov. 15, 2021
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) finally laid to rest the rule for Medicare Coverage of Innovative Technology (MCIT), a policy proposal that found favor with industry and with several patient groups. However, the news comes shortly after a bipartisan group of 10 senators had penned a letter to the agency to reissue the rule, reinforcing the prospect that the MCIT proposal will find widespread support in the halls of Congress in 2022.
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Medicare puzzle

Ten US senators press CMS to resurrect rule for Medicare breakthrough device coverage

Nov. 9, 2021
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) has withdrawn the proposal to provide automatic Medicare coverage of FDA breakthrough devices, but the proposal may not be as dead as it once seemed.
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U.S. flag, stethoscope

Stakeholders jeer Medicare physician fee final for 2022, but telehealth scores a win

Nov. 3, 2021
By Mark McCarty
The U.S. CMS waded into controversy with two final rules calendar year 2022, drawing fire from device makers and doctors who allege that cuts in rates for physicians will hamper beneficiary access. Software developers working in the telehealth space will find much to cheer, however, given that some telehealth services that were covered during the COVID-19 pandemic will be covered after the pandemic has passed.
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Kidneys

CMS makes first award under ESRD add-on payment program

Nov. 1, 2021
By Mark McCarty
The U.S. Center for Medicare & Medicaid Services (CMS) has made the first award to a product under an add-on payment for treatment of end-stage renal disease (ESRD) as part of the prospective payment schedule for calendar year 2022. Outset Medical Inc., of San Jose, Calif., snared the first of these novel add-on payments for medical technologies under the ESRD prospective payment system, but device makers working the ESRD space can expect to see many similar such awards in the years ahead.
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Gavel and scales

Omni strikes again in false claims case against MD Spine Solutions

Oct. 21, 2021
By Mark McCarty
Enforcement against false claims filed with federal health care programs continues to snare a number of testing clinics as demonstrated by the recent news that a clinical lab has come to terms with federal prosecutors over urine drug testing. MD Spine Solutions LLC, of Reno, Nevada, has agreed to pay up to $16 million to settle allegations that it performed unnecessary urine drug tests, a case brought to the attention of the courts not by a former employee, but by Omni Healthcare Inc., which has been active in the False Claims Act space, thus highlighting the hazards of third-party litigation to clinical lab operators.
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U.S. flag, stethoscope

Med-tech trade associations tee off on withdrawal of MCIT rule

Oct. 19, 2021
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services’ (CMS) withdrawal of a proposal to provide automatic coverage of FDA-designated breakthrough devices has drawn criticism from device makers, but the industrial reaction runs the gamut.
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telehealth-telemed-online-doctor.png

EY Pulse: Three ways med-tech companies can capitalize on pandemic shifts

Oct. 13, 2021
By Annette Boyle
The Ernst & Young Pulse of the Industry 2021 report outlined several ways med-tech companies can benefit from fundamental changes in business wrought by the pandemic to build a stronger foundation for the future. While the need for more agile supply chains and the drive to measure social and environmental impact as well as financial metrics have affected all economic sectors, COVID-19 transformed the med-tech industry in specific ways that could have long-lasting impact.
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Central nervous system

OIG recommends precertification for Part B neurostimulation

Oct. 7, 2021
By Mark McCarty
The U.S. Office of Inspector General (OIG) said a review of claims for implant of neurostimulation devices indicates that many of these claims lack the data to ensure that the devices were appropriately implanted.
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