Medicare Bonus Payments Awarded To Cook’s Stent, Second Sight’s Eye Implant

Cook Medical’s Zilver PTX stent and Second Sight Medical Products’ Argus II retinal prosthesis system will enjoy new-technology add-on payments in 2014 under CMS’ hospital inpatient prospective payment system final rule.

Three products, including two devices, will receive Medicare hospital inpatient new-technology add-on payments for the first time in fiscal year 2014. Two additional devices that had sought the payments will not qualify because they have yet to gain FDA approval.

CMS announced the decisions in its final inpatient prospective payment system rule, issued Aug. 2 and set to take effect Oct. 1.

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

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By 

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

Zika Virus Test Among 4 New FDA Device Classifications

 
• By 

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

More from Medtech Insight

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.

BD To Shift China-Facing Production, Ramp Up US Output With $2.5B To Counter Tariff Blow

 
• By 

BD is accelerating transitions of product sourcing for China to avoid tariffs. Historically, products like Vacutainer were exported from Sumter, SC, to China, and Flush was shipped from Columbus, NE.

Zika Virus Test Among 4 New FDA Device Classifications

 
• By 

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel