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Home » Topics » Regulatory » CMS

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Telehealth illustration

MedPAC may recommend pilot coverage for telehealth post-PHE

Jan. 25, 2021
By Mark McCarty
The impetus to provide more Medicare coverage of telehealth may prove irresistible, but the Medicare Payment Advisory Commission (MedPAC) has some reservations, including that telehealth payment rates should not favor companies like Dallas-based Teladoc Health Inc. over bricks-and-mortar clinics. This and other considerations are driving the commission toward a recommendation that a two-year telehealth pilot program would be more appropriate than simply jumping into a quickly broadened world of Medicare telehealth coverage.
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3D rendering of heart, mitral valve

CMS rewrite of mitral valve memo adds secondary regurgitation, doubles market

Jan. 20, 2021
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) issued a final version of a proposed rewrite of the national coverage determination (NCD) for mitral valve repair devices that includes a coverage with evidence development (CED) mandate. The final also retains the draft’s provisions for secondary mitral valve regurgitation, which analysts say will double or even triple the market for devices thus approved by the FDA.
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Regulatory front for Jan. 20, 2021

Jan. 20, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS, OIG differ on CERT program.
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Regulatory front for Jan. 15, 2021

Jan. 15, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS wraps up prior authorization rule; ITC finds no violation of Section 337.
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Medicare puzzle

CMS delays proposed reset of ‘reasonable and necessary’ in MCIT final rule

Jan. 14, 2021
By Mark McCarty
The Medicare Coverage of Innovative Technology (MCIT) program drew rave reviews when it was unveiled, but the associated proposal to redefine the term “reasonable and necessary” met with skepticism. The final rule includes some discussion of how private payer coverage might be leveraged to broaden the definition, but the Centers for Medicare & Medicaid Services (CMS) nonetheless punted on the question for now, promising to tackle it within a year.
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Regulatory front for Jan. 12, 2021

Jan. 12, 2021
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS finalizes MCIT rule; HHS lists permanent waivers of notification; FDA schedules advisory meeting for latest Lutonix model; HHS announces telehealth grants; Telemarketer caught in sting over telehealth fraud; Churn at FDA chief counsel’s office.
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Regulatory front for Jan. 4, 2021

Jan. 4, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Curative test for COVID should be conducted per product label; FDA posts MEA final guidance; CMS eyes radiology quality measures; Ra Medical agrees to fines.
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Glass globe

2020 Year in Review: Rescission of U.S. FDA regulation of lab-developed tests broke new ground

Dec. 31, 2020
By Mark McCarty
As is the case with many national governments, the U.S. federal government does not routinely measure its activities in the calendar year, but we at BioWorld don’t share that outlook. CY 2020 was odd in more ways than one from a regulatory standpoint, and thus we offer our version of a regulatory top 10 for a year that might not look much better in the rear-view mirror than it has looked as a current event.
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Regulatory front for Dec. 28, 2020

Dec. 28, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS unveils push toward digital collection of quality measures; NIH awards for ‘outside-the-box’ projects under RADx; ISO posts IP management standard.
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Regulatory front

FDA posts three guidances under safety and performance program

Dec. 11, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA delays comment period for electromagnetic compatibility draft; CMS, ONC post info sharing, prior authorization rule; Van Hollen debuts diagnostic accuracy bill; CDC updates POC testing guidelines; GAO: Specimen biopsy handling errors relatively low.
Read More
Previous 1 2 … 20 21 22 23 24 25 26 27 28 … 32 33 Next

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