LCD Reference Article Response To Comments Article

Response to Comments: Platelet Rich Plasma

A58819

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Article ID
A58819
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Platelet Rich Plasma
Article Type
Response to Comments
Original Effective Date
08/01/2021
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As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the Platelet Rich Plasma LCD. The official notice period for the final LCD begins on June 10, 2021, and the final determination will become effective on August 1, 2021.

Response To Comments

Number Comment Response
1

One commenter indicated there was “clinical trial evidence that supports coverage of Platelet Rich Plasma for “specific conditions” and then went on to explain how PRP has been studied to be “an effective treatment for knee osteoarthritis.” The presenter acknowledged the clinical studies have “heterogeneity of PRP preparation” and variability for the “follow up duration” in the studies and further acknowledged these variabilities created difficulty in “interpreting the results differently”.

We disagree. The clinical utility of the PRP for knee osteoarthritis has not been shown to be reasonable or necessary and assessing PRP for knee osteoarthritis cannot be assessed based only on the non-inferiority, effectiveness or superior effect compared with hyaluronic acid or acetaminophen.

Furthermore, the issue in the medical literature is more than just the variability in the PRP preparation and follow up duration. The clinical studies have also shown to be have potential bias in the clinical trials, a variability between the number of injections, an interval variability between the injections, a variability between the volume of PRP injected, the duration between the injections, the frequency of the injections, and the type of the PRP injected.

The coverage determination will remain non-covered for all platelet rich plasma injections and/or applications as a means of managing musculoskeletal injuries and/or joint conditions.

 

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L38937 - Platelet Rich Plasma
Related National Coverage Documents
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Updated On Effective Dates Status
06/04/2021 08/01/2021 - N/A Currently in Effect You are here

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