The Agency for Healthcare Research and Quality (AHRQ) had commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Platelet-rich Plasma (PRP) for Wound Care in the Medicare Population. The Centers for Medicare & Medicaid Services (CMS) requested this report from the EPC Program at AHRQ in response to a reconsideration request submitted by a PRP manufacturer.
Medicare coverage for the PRP has been restricted to patients with chronic non-healing diabetic wounds, pressure wounds and venous wounds under Coverage with Evidence Development (CED) since 2012. Commercial payers did not cover the PRP in most cases. On March 23, 2020 the AHRQ sought public input on the PRP Evidence Review for the Medicare population.
CMS has completed a thorough review of published evidence to determine if the use of PRP in patients with chronic non-healing pressure ulcers, venous ulcers, and diabetic foot ulcers is reasonable and necessary under the Medicare program. This document is now in its final stage of production.
GIRS has assisted our clients to submit clinical data and to track the outcomes of the AHRQ and other review organizations HTA outcomes. It is important to track and submit data to review organizations when they seek public input as the final decisions and outcomes influence the coverage decisions of the U.S. insurers.
Some key questions that the PRP evidence review considered were:
Comparative Effectiveness Questions: For patients with diabetic, venous and pressure chronic wounds, what are the benefits and risks of treatments that include:
- PRP alone,
- PRP with other standard of care wound care treatments,
- PRP compared to other wound care treatments.
The patient-related outcomes that were considered: These include completely closed/healed wounds (skin closure with complete re-epithelialization without drainage or dressing requirements), time to complete wound closure, wound reoccurrence, risk of developing wound infection, amputation, hospitalization (frequency and duration), return to baseline activities and function, reduction of wound size, pain, opioid medication use, exudate and odor, quality of life and adverse effects
Differences in formulations and applications: the review considered the differences in formulation techniques, components differences in application techniques, frequency of application and “dosage” (amounts applied)?
Study characteristics: the review considered comparators, patient characteristics of enrollees, measurement and assessment methods, wound characteristics, method of applying skin PRP, etc.
The review also considered what kinds of PRPs are being marketed in the U.S.
The EPC also considered what PRPs are in ongoing clinical trials, the best study designs for producing better evidence, and the gaps in the research.
The plan was to conduct a comprehensive database search and to use relevant systematic reviews and meta-analysis to identify additional existing and new literature. Searches were also conducted of FDA, ClinicalTrials.gov, Health Canada, Medicines and Healthcare Products Regulatory Agency (MHRA), AHRQ’s Horizon Scanning System, the International Working Group on the Diabetic Foot (IWGDF) website, conference proceedings, patient advocate group websites, and medical society websites. In addition, public comment was sought from all stakeholders on March 20th, 2020.
Draft Conclusions. GIRS communicated with the EPC on a Draft Report that was found and on the next steps. We have verified that the statutory due date for posting the proposed decision is 10/3/2020.
The draft conclusions for inclusion in the Final Report show that PRP shortens healing time and reduces wound size, in individuals with lower extremity diabetic ulcers.
The evidence is insufficient to estimate an effect of autologous platelet-rich plasma on wound healing in individuals with lower extremity venous ulcers or pressure ulcers.
The evidence review also shows the limitations of PRP clinical studies including inadequate description of offloading, wound care procedures, wound characteristics, PRP formulation techniques, concentration and volume, inadequate length of follow-up, and lack of stratification by comorbidities and other patient characteristics.
What can you do?
Once CMS posts the proposed decision memo, you can provide any more information that you may have on PRP. There is a 30-day comment period, and you can provide to CMS any information that is not included in the assessment. But if you are going to submit information about studies in progress, CMS will only look at peer-reviewed studies, not studies currently in progress that have not been peer-reviewed and published.
What we do
The GIRS Value Pointer Outcomes Strategies® reviews our clients’ study designs and assists with the development of payer – desired clinical outcomes strategies. We can help you to develop clinical studies that address the weaknesses that characterize the data for PRPs.
We work with Health Technology Assessment (HTA) organizations to provide the evidence for review and then we educate payers so that positive coverage can be implemented for our clients’ technologies. We also have helped our clients obtain coverage with CED.
We also have over 10 years of experience supporting PRP companies with reimbursement and clinical outcomes strategies. We can assist you to comment and to provide additional evidence to CMS on PRPs. GIRS is also ready and willing to help mitigate and manage any negative coverage effects that might occur from an unfavorable review of your PRP product.
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About GIRS
For more than 17 years, GIRS has been assisting medical technology manufacturers with their market uptake and reimbursement strategies so that patients can have access to the care that they need. To implement successful market access strategies, the GIRS Value Discovery Landscape Assessments® team and the Payer Advocacy Compass® team work together to develop and implement foundation reimbursement landscape and payer advocacy strategies to obtain positive coverage, appropriate payment, and innovative payer contracting arrangements to improve market uptake. For more information, email us at info@girsinc.com or call us at 901-834-9119.
Disclaimer: The information in this blog is based on payer information which is dynamic. It is accurate at the time of posting but should not be construed to be reimbursement or legal advice. CPT® is the trademark of the American Medical Association (AMA).