1. Medtech Insight
  2. >>Policy & Regulation

CMS Proposes Extra Payments On CustomFlex Iris, Single-Use Duodenoscope, Heart Device

Medicare agency discusses unique nature of devices in outpatient payment system proposed rule

 
• By Sue Darcey

The Centers for Medicare and Medicaid Services highlighted three FDA breakthrough devices it is proposing for additional pass-through payments in its 2021 outpatient pay rule.

Eye
An artificial iris is one of the technologies proposed by CMS for pass-through payments

The Centers for Medicare and Medicaid Services (CMS) wants to give additional pass-through payments to a few novel devices: an artificial iris, a single-use duodenoscope, and a brain stimulation product to treat heart failure.

The US Medicare agency outlined the recommended payments in its 2021 Outpatient Prospective Payment System (OPPS) and ambulatory surgery center (ASC) proposed rules, which were released on 7 August...

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
Start Free Trial

Already a subscriber?

More from Policy & Regulation

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

 
• By Brian Bossetta

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 Ashley Yeo

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 Elizabeth Orr

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FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

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’

 
• By Natasha Barrow

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 Shubham Singh

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 Elizabeth Orr

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