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Labs Have Two More Months To Report Private-Payer Data, CMS Says

 
• By Sue Darcey

The US Medicare agency will allow laboratories two additional months – until May 30, 2017 – to report their private-payer pricing data, which will serve as the basis for clinical laboratory Medicare reimbursements starting in January. The agency said it is responding to industry feedback that more time is needed to collect the data.

The Center for Medicare and Medicaid Services will exercise "enforcement discretion" for two more months, giving laboratories until May 30, 2017 to report their private-payer pricing data to the agency, as required under the Protecting Access to Medicare Act, the agency announced March 30.

PAMA requires labs to report payment rates from private insurers and test volumes to support a transition to market-based Medicare...

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Makary And Oz Tout Successes At Their Respective Agencies, Say They Are Breaking Down Walls

 
• By Brian Bossetta

Nearly one year into leading their agencies, US FDA Commission Marty Makary and CMS Administrator Mehmet Oz took to the stage together at the Milken Institute’s Future of Health Summit 2025 to highlight what they see as progress and lay out plans for the road ahead.

Global Medtech Guidance Tracker: October 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight’s Guidance Tracker. Over 60 documents have been posted on the tracker since its last update.

Under Pressure: How To Safeguard The EU Responsible Person

 
• By Amanda Maxwell

The roles and responsibilities of EU medtech’s persons responsible for regulatory compliance vary widely in role and risk exposure. The recent TEAM-PRRC meeting highlighted how vulnerable they can be and the steps to protect themselves.

Number of Persons Responsible For Regulatory Compliance Grows Nearly 10%

 
• By Amanda Maxwell

The EU’s Medical Device and IVD Regulations require every manufacturer and authorized representative to have a PRRC. As compliance becomes mandatory for increasing numbers of manufacturers, figures are soaring and this role is becoming both increasingly distinctive and more complex.

More from Medtech Insight

Under Pressure: How To Safeguard The EU Responsible Person

 
• By Amanda Maxwell

The roles and responsibilities of EU medtech’s persons responsible for regulatory compliance vary widely in role and risk exposure. The recent TEAM-PRRC meeting highlighted how vulnerable they can be and the steps to protect themselves.

Viome’s CEO To Expand Into Clinical Diagnostics ‘For Which There Are No Solutions’ With AI, RNA Test

 
• By Marion Webb

Viome Life Sciences accelerates its push into clinical diagnostics with studies in colorectal cancer and a major partnership with Microsoft to scale its molecular data analysis platform. Viome leverages RNA analysis and AI to detect disease at the molecular level and personalize preventive health.

Philips Ramps Up US Production, Seeks To Swiftly Move On From New FDA Warning Letter

 
• By Shubham Singh

Philips puts its latest “disappointing” warning letter into context, while announcing progress in regulatory performance, expanded US production and tariff resilience plans