US CMS Opens Medicare National Coverage Analysis For NGS Germline Mutation Tests

The CMS opened a national coverage analysis tracking sheet on 29 April to reconsider evidence for next-generation sequencing tests of germline mutations. These assays identify beneficiaries with hereditary cancer who may benefit from targeted treatments based on the tests’ conclusions about carcinogenic genetic mutations passed on by patients’ parents.

DNA detail background with selective focus
• Source: shutterstock.com

The US Centers for Medicare and Medicaid Services (CMS) said on 29 April that it is considering reimbursement of next-generation sequencing tests that can pinpoint cancer-causing germline mutations in a beneficiary and help provide personalized therapies to treat cancers.

“It is important that tests detect somatic (cancer) and germline (inherited) mutations accurately and produce valid results that are useful...

More from Policy & Regulation

More from Medtech Insight

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

Endo Tools, Fujifilm Partner to Fast-Track Endomina Rollout Across MEA Region

 
• By 

CEO Alexandre Chau told Medtech Insight that the Middle East and Africa presented the ideal mix of market potential, physician training opportunities, and regulatory readiness when the company was considering expansion markets beyond Europe and the US.