Reimbursement In Brief

CMS proposes new indications for implanted cardiac pacemakers, declines coverage reconsideration request from Cyberonics. Trustees project Medicare solvency until 2026. More reimbursement briefs.

CMS posted a proposed decision memo May 29 stating that the existing clinical evidence supports coverage of implanted permanent single-chamber or dual-chamber cardiac pacemakers in patients with documented symptomatic bradycardia due to sinus node dysfunction or second degree and/or third degree atrioventricular block. The proposal would noncover 14 additional indications, including asymptomatic first-degree atrioventricular block and asymptomatic sinus bradycardia, based on findings of insufficient evidence that implanted cardiac pacemakers are reasonable and necessary for the conditions. CMS notes that symptoms of bradycardia are those that are directly attributable to a heart rate of less than 60 beats per minute, such as syncope, seizures, congestive heart failure, dizziness or confusion.

CMS opened the national coverage analysis in January in response to a letter from the Heart Rhythm Society and the...

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

Surgical Robotics CEOs Talk Metrics For Success, Valuations, Competition And IPO Outlook

 
• By 

Leaders of robotic systems companies Distalmotion, Neocis and Noah Medical discussed success metrics, competition and funding. Institutional investors are focusing on utilization, procedure rates and a clear path to profitability as the IPO window reopens, BTIG analyst Ryan Zimmerman said.

Serious Injuries Tied To Medtronic Bravo GERD Diagnosing System

 

The US FDA has issued an early alert to notify consumers about serious risks associated with a recall from Medtronic and its subsidiary Given Imaging. The alert concerns delivery capsules for diagnosing GERD.

DME And Diagnostics In Crosshairs As DOJ ‘Follows The Money’

 
• By 

The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.

FDA Blocks Some Olympus Endoscopes From Entering US

 

After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.

More from Medtech Insight

Dxcover Launches US Operations With New Headquarters In Tennessee

 

Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.

EnsoData Boosts AI Sleep Tech With $20M Series B Funding, Targets Underdiagnosis Crisis

 
• By 

EnsoData positions itself as device-agnostic and interoperable, with FDA-cleared software that can integrate with all major devices. CEO Mortara said this flexibility helps maximize patient reach by enabling both direct provider engagement and integration with device manufacturers.

FDA Blocks Some Olympus Endoscopes From Entering US

 

After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.