1. Medtech Insight
  2. >>Policy & Regulation

Reimbursement In Brief

Medicare will cover clinical trials of extracorporeal photopheresis in lung transplant recipients. Government Accountability Office reports on GPO oversight. More reimbursement news.

Medicare will nationally cover extracorporeal photopheresis for the treatment of bronchiolitis obliterans syndrome in lung transplant patients, but only when the procedure is done as part of a clinical research study meeting certain conditions. CMS announced the policy in a final decision issued May 2. (See Also see "Reimbursement In Brief" - Medtech Insight, 6 February, 2012..) In a new twist also seen in a recent bariatric surgery coverage proposal, the agency said the ECP clinical studies must be approved within two years; if there are no approved studies by May 2, 2014, the coverage policy will expire. (See Also see "CMS Obesity Coverage Proposal Includes Sunset Deadlines For CED Studies" - Medtech Insight, 9 April, 2012..)

The policy expands on the Medicare-allowed uses of extracorporeal photopheresis, a procedure in which a patient's white blood cells are...

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

US FDA Unveils Plans To Consolidate Support Services

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 
• By Brian Bossetta

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

MDUFA VI Launches With Public Meeting, Call For Comments

 
• By Elizabeth Orr

Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.

Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation

 
• By Sue Sutter

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.

More from Medtech Insight

‘UK Must Put Adoption On A Par With Innovation’

 
• By Ashley Yeo

Market access concerns dominated at the annual BioWales In London event, where AstraZeneca set out industry’s priorities and the UK Office for Life Sciences struck an optimistic tone about how the UK will lastingly improve uptake of innovation.

Sofinnova And NVIDIA Partner To ‘Supercharge’ Computation For European Startups

 
• By Natasha Barrow

European venture capital firm Sofinnova Partners’ portfolio companies BioCorteX, Bioptimus, Cure51 and Latent Labs will benefit from the investor’s new partnership with tech giant NVIDIA.

MDUFA VI Launches With Public Meeting, Call For Comments

 
• By Elizabeth Orr

Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.