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Home » Topics » Regulatory » CMS

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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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Health, medical icons
2021 Medtech Conference

Existing authorities are adequate for breakthrough device coverage in U.S.

Sep. 28, 2021
By Mark McCarty
The demise of the Medicare Coverage of Innovative Technologies (MCIT) rule may not be the end of the breakthrough devices coverage story, but Lee Fleisher of the U.S. Centers for Medicare & Medicaid Services (CMS) said the MCIT rule was riddled with deficiencies. Fleisher said CMS is of the view that expedited coverage of breakthrough medical devices would be better handled under existing statutory authorities, suggesting the agency sees no need for the MCIT-driven provisions of the Cures 2.0 legislation.
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Doctor performing surgery

Cardiologist hit with nearly $7M settlement over allegations of unnecessary ablations, stenting

Sep. 20, 2021
By Mark McCarty
Physicians occasionally go over the line where Medicare services are concerned, but the U.S. Department of Justice announced Sept. 15 that a cardiologist in Orlando, Fla., went farther than the ordinary illicit billing.
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U.S. flag, stethoscope

CMS rescinds MCIT rule ahead of schedule

Sep. 15, 2021
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) has withdrawn the rule for the Medicare Coverage of Innovative Technologies (MCIT) program, an action that predates the agency’s self-imposed deadline of December 2021 by three months. The agency cited some previously discussed issues with the rule, but the move was blasted by industry as thwarting the support of the majority of stakeholders.
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U.S. flag, stethoscope

Medicare panel backs Inspire Medical’s bid for rate boost for hypoglossal stimulation device

Aug. 23, 2021
By Mark McCarty
Medicare coverage does not necessarily mean appropriate reimbursement levels, a point pressed by Inspire Medical Systems Inc. at the Aug. 23 Medicare outpatient advisory panel hearing. The panel agreed that the company’s hypoglossal nerve stimulation (HNS) device for sleep apnea was subject to an inappropriate device offset figure, which could lead to a Medicare rate increase of more than $7,000 and a significant boost of sales of the company’s flagship Inspire HNS device.
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