BRCA Reimbursement Cut Heightens Tensions Between CMS And Lab Industry

CMS has extended the comment period on its nearly 50 percent BRCA testing reimbursement cut to the end of February. But comments from lab and diagnostics groups so far try to underscore the “capriciousness and lack of transparency” that CMS displayed when it made the cut. Experts say the agency is unlikely to change its mind.

CMS extended the comment period on BRCA diagnostic testing reimbursement to Feb. 28, but the consensus among experts is that the agency will not reverse its nearly 50 percent reimbursement cut on sequencing of the BRCA1 and BRCA2 genes for the likelihood of inheriting breast and ovarian cancer.

“Once [CMS has] set something, they won’t change it up or down,” said Charles Root, CEO of Medicare compliance and...

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 United States

FDA Document Request Denied As Case Against SurModics Merger Intensifies

 
• By 

A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.

Abbott Lowers Outlook But Headwinds Are Temporary

 

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

Device Sterilization Plants Get Extra 2 Years To Comply On EtO Phase-Out

 
• By 

The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.

Numerous Injuries Prompt Class I Recall Of Dexcom CGM Receivers

 

Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.

More from North America

Experts Call For Database Of Medical Device Labels

 
• By 

A recent JAMA column called for the US FDA to create an online database of medical device labeling, arguing that the move would increase transparency and help researchers, among other benefits. Medtech Insight discussed the idea with the paper’s lead author.

Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 

A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.

With CMS Coverage Established, Medtronic Looks To Next Steps For Renal Denervation

 
• By 

US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the