Local Medicare Contractors Propose Coverage For Novocure’s Optune

The Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have issued a proposed local coverage determination that provides coverage of Novocure’s Optune Tumor Treating Fields device for treating newly diagnosed glioblastoma at certain cancer centers.

Glioblastoma stem cells organized in tumor niche formation - Image
• Source: shutterstock.com

The Durable Medical Equipment Medicare Administrative Contractors (DME MACs) are recommending local Medicare coverage of Novocure’s Optune Tumor Treating Fields device for treating newly diagnosed glioblastomas, an aggressive type of brain cancer.

Tumor Treating Fields are tuned electric fields created by the Optune device to disrupt solid tumor cells’ ability to divide...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Policy & Regulation

‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

FDA Outlines Responsibilities For Owners Of Transferred 510(k)s

 
• By 

The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.

US House Budget Sets FDA FY26 Funding At $3.2B

 

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

Panel: FDA’s Home Healthcare Initiative Holds Promise, But Challenges Remain

 
• By 

During a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety.

More from Medtech Insight

‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

Ultrahuman Launches Home Health Monitoring

 

Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.

FDA Outlines Responsibilities For Owners Of Transferred 510(k)s

 
• By 

The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.