BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Thursday, June 12, 2025
Home » Topics » Regulatory » CMS

CMS
CMS RSS Feed RSS

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.
Read More

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.
Read More
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.
Read More

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.
Read More
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
Regulatory front

Senators sound off on E&M offsets

Dec. 9, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USPTO finalizes SAS rule, U.S. senators press case for permanent telehealth, CMS no fan of national coverage policy for Allomap, TGA posts guidance for class I tests, Marburg MCMs protected under PREP.
Read More
U.S. flag, stethoscope

Medicare outpatient final retains prior authorization mandate for two spinal procedures

Dec. 3, 2020
By Mark McCarty
Of all the things that irritate physicians about health insurance, prior authorization might be at the top of the list. That didn’t stop the U.S. Centers for Medicare & Medicaid Service (CMS) from imposing a prior authorization requirement for the implant of spinal stimulators and for cervical fusion with disc removal in the calendar year 2021 Medicare outpatient prospective payment system, however.
Read More
Medicare puzzle

CMS finalizes changes to E&M services in physician fee final for calendar year 2021

Dec. 2, 2020
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) has posted the Medicare physician fee schedule for calendar year 2021, a document that has drawn blistering reviews from a number of stakeholders. The criticisms generally revolve around the impact of higher rates for evaluation and management (E&M) services on other rates, but there is already legislation in play on Capitol Hill that would reverse the changes wrought by increases in rates for E&M services.
Read More
Regulatory front

CMS posts final coverage memos for VADs, artificial hearts

Dec. 2, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA slaps two companies for illicit COVID offerings; FDA approves new PET imaging agent for prostate cancer.
Read More
Colorectal cancer illustration

Test sensitivity, specificity debated in Medicare colorectal cancer biomarker coverage draft

Nov. 24, 2020
By Mark McCarty
The draft version of the U.S. Medicare national coverage analysis for blood-based biomarker tests for colorectal cancer (CRC) engendered a large body of support, but several stakeholders recommended that the Centers for Medicare & Medicaid Services (CMS) avoid prescriptiveness regarding the sensitivity and specificity for any tests that would be covered under the policy.
Read More
Previous 1 2 … 20 21 22 23 24 25 26 27 28 … 32 33 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 11, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for June 12, 2025.
  • AI-generated illustration of heart and metabolic impact

    Deep Apple signs big Novo deal for cardiometabolic small molecules

    BioWorld
    Deep Apple Therapeutics Inc. could bring in as much as $812 million in a new collaboration and license deal with Novo Nordisk A/S. The total includes an...
  • DNA double helix under a magnifying glass

    23andme genetic privacy concerns garner Congressional scrutiny

    BioWorld MedTech
    The bankruptcy of genetic testing service 23andme Holding Corp. prompted a reaction from many quarters, but a June 11 Senate hearing highlighted an interest in...
  • Red and blue bispecific antibodies

    3Sbio revs on with phase II data in tight PD-1/VEGF bispecific race

    BioWorld
    3Sbio Inc. reported interim phase II study results of its PD-1/VEGF bispecific antibody, SSGJ-707 – a “fabulous” asset, according to Pfizer Inc. CEO Albert...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing