The Centers for Medicare and Medicaid Services has announced coverage of platelet-rich plasma gel for chronic wounds, but only for patients who are enrolled in clinical trials that meet the agency’s criteria.
“The available evidence does not permit us to conclude that use of autologous PRP improves health outcomes in beneficiaries with chronic diabetic, pressure, and/or venous wounds,” the agency wrote in itsdecision statement Therefore, trials are needed to prove effectiveness.
The decision comes after CMS rejection of coverage since 1992, according to Cytomedix of Gaithersburg, Md., which manufactures a device called AutoloGel that produces PRP from a patient’s own blood. “This determination reverses a nearly 20-year non-coverage determination for PRP and provides for an appropriate research study with practical study designs we are confident will demonstrate that patients treated with our autologous PRP product, the AutoloGel System, experience clinically significant health outcomes,” Martin P. Rosendale, CEO of Cytomedix, said in a statement.
Cytomedix submitted another request in October 2011 for CMS review of its PRP therapy, which was approved under the coverage with evidence development (CED) program.
Under the program, services, equipment, and supplies are covered through Medicare and Medicaid while a product is further investigated. CMS noted in its decision that it “is evaluating PRP as a service, and not a specific system for administrating PRP.”
In the PRP process, autologous blood is centrifuged to produce a concentrate of platelets and plasma proteins. Individual growth factors are not identified or separated, but additives are used to change the consistency.
Autologous PRP has had many uses over the years, including use as an adhesive in plastic surgery and as filler for acute wounds. It has also been used to treat amateur and professional athletes – such as golfer Tiger Woods, basketball player Kobe Bryant, and baseball star Alex Rodriguez – to help heal tendons and ligaments, and is growing in popularity in the sports world, according to recent consumer news reports.
According to the CMS, to continue being covered for wound healing PRP therapy must show complete wound healing in patients and a reduction of wound size or healing trajectory. It also must help a patient’s ability to return to previous function and normal activities. The studies have to be prospective and enroll Medicare beneficiaries with chronic nonhealing diabetic, pressure, and/or venous wounds who are receiving optimal care, in addition to the therapy.
The agency must receive all pertinent data by August 2014.
Cytomedix said that it has been in talks with CMS about trials. “We look forward to continuing to work with CMS in the coming weeks in further defining the specifics of the protocols for the research studies and clinical questions to be answered through the CED program,” said Mr. Rosendale.