LCD Reference Article Response To Comments Article

Response to Comments: Platelet Rich Plasma Injections for Non-Wound Injections

A58967

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A58967
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Article Title
Response to Comments: Platelet Rich Plasma Injections for Non-Wound Injections
Article Type
Response to Comments
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01/23/2022
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This article is response to comments receive for the proposed non-coverage policy on Platelet Rich Plasma Injections for Non-Wound Injections.

Response To Comments

Number Comment Response
1

Comments were received from the American Association of Oral and Maxillofacial Surgeons (AAOMS). They submitted an additional study to provide evidence of benefit on the use of PRP in oral and maxillofacial surgery, specifically with major bone graft procedures. 

Thank you for the submission of additional literature. This article has been added to the review in the LCD. While this article suggests potential promise, the small numbers, prospective study design, lack of comparator, and lack of long-term outcome data do not provide robust evidence to demonstrate the efficacy of PRP in this population. If additional studies are published that support this indication, they can be reviewed through the LCD reconsideration process.

2

AAOMS states “Use of PRP is vital as a bioactive material in certain types of bone grafting scenarios. PRP is essential in cases of osteoradionecrosis; the treatment of failed bone grafts; and grafting in the presence of infection. It has been documented that PRP has been helpful with soft tissue repair and revascularization of the operative site.”

Literature was not submitted to support the role of PRP in these conditions. If additional studies are published that support this indication, they can be reviewed through the LCD reconsideration process.

3

Comments were received from Terumo BTC, a blood component, therapeutic apheresis, cellular and autologous biologic technologies company requesting medical necessity for PRP. They provided additional clinical studies to support the use of PRP for a variety of conditions. 

Thank for the citation list. Several studies were already included in the LCD; the others were reviewed and added to the LCD if appropriate. Non-English studies were excluded. Park et al. provide a Level I study for the use of PRP in osteoarthritis of the knee. While this study is high-quality, its sample size was too small to extrapolate to a larger population. It alone cannot address the lack of standardization across the body of literature on this subject. Efforts to achieve this were attempted with several meta-analyses, which were included in the list. However, meta-analysis is ineffective when there is a lack of high-quality data and does not address the fundamental issues as multiple confounders such as the source of stem cells, most effective delivery method, the role of surgery, and type and amount of PRP used. As more high-quality literature is produced, answers to these questions may be found. In that case, the role of PRP for the treatment of osteoarthritis of the knee can be re-evaluated through the LCD reconsideration process.

4

Zimmer Biomet, a manufacturer of devices for preparation for PRP, submitted comments that they believe the use of PRP for Tendinosis (recalcitrant tendinosis): Chronic Lateral Epicondylitis (Tennis Elbow), Chronic Plantar Fasciitis, Chronic Achilles Tendinopathy, Chronic Patellar Tendinopathy (Jumper’s Knee) is well supported in clinical literature. Additional literature to support use was submitted. These comments included:

  1. Mishra et al. study, while there was a lack of improvement in global pain scores at 12 weeks, the authors did report improvement at 24 weeks which was not included in the LCD evidence analysis.
  2. Watt et al. 2018 was submitted which reviewed a study comparing leukocyte-rich platelet-rich plasma injections with a surgical invention for the management of refractory tennis elbow.
  3. The commenters state that they did not feel that the review of the 2014 Cochrane database review by Moraes et al. was a full assessment of the reported outcomes and pointed out that the authors did report evidence to support the use of PRP to treat lateral epicondylitis through improved function (PRTEE, Liverpool Elbow scores) vs. control at both 3 and 6 months (p=0.044, p=0.00074).
  4. The commentator notes in the Fitzpatricks et al. (2017) study differentiates between leukocyte rich and leukocyte poor PRPS for treatment of tendinopathies. It concludes that leukocyte-rich PRP improves outcomes in tendinopathies. They state, “the authors concluded that the analysis found strong evidence that LR-PRP improves outcomes in tendinopathy and that the type of PRP and the techniques used to affect the outcomes and should always be included in any future meta-analysis.”
  1. While the Mishra study (2013) did report improvement in the PRP group at 24 weeks compared to the control group, the results were not statically significant (P= 0.037).
  2. Watt et al. were not included in the proposed LCD. In this study, patients with chronic tennis elbow were randomized to surgery vs. PRP. They reported that surgical patients have lower pain scores at 12 months and that 70% of PRP patients avoided surgery. However, there was not a conservative arm, so the outcomes without either intervention are unknown. Additionally, the number of patients who received PRP who eventually proceeded with surgical management after 12 months is unknown. Due to the nature of the study blinding was not feasible but still introduces the risk of bias.
  3. While the Cochrane review did report that three elbow epicondylitis trials showed a statically significant difference in favor of PRP, the author also acknowledges the clinical significance of this finding is uncertain. The available evidence was deemed insufficient to conclude if the effect of PRP will “differ importunately in individual conditions.”
  4. The investigation of leukocyte poor vs leukocyte rich plasma is a useful step in providing evidence towards more standardization of the PRP preparations. Clinical trials must be use standardizations to gain the evidence needed to fully understand and evaluate the role of PRP. While this study is a step towards providing evidence to support one factor it has not been reproduced or confirmed. The authors are accurate in stating that future meta-analysis should clarify platelet rich or platelet poor PRP but unfortunately many of the studies that would be included in analysis do not specify this information as that has not been a subject of investigation in many of the PRP studies
5

Zimmer Biomet provided an evidence table of twenty articles are published on the safety and performance of the Zimmer Biomet devices used to treat tendinosis, which are summarized in the evidence table below.

Thank you for the evidence summary. The performance of specific devices for the preparation of PRP is beyond the scope of the LCD. The evidence table provided represented studies in a population notably younger than the average Medicare population. Only one of the submitted studies includes patients over 65; therefore, extrapolation to the Medicare population is uncertain.

Nonetheless, we agree that there is clinical literature that favors the safety of PRP. However, this does not address the fundamental problem of lack of standardized protocols and wide variations in procedural technique. As stated in the LCD, for a treatment to be considered medically reasonable and necessary per 1862(a)(1)(A) of The Act must be appropriate, including duration and frequency furnished following accepted standards of medical practice for the condition. The lack of accepted standards of medical practice and, therefore, a lack of consistency in these studies has resulted in a heterogeneous body of literature that does not answer the fundamental questions of safety and efficacy nor provide standard practices for use. Once PRP preparations, injection volumes, and techniques are more standardized, the literature may provide these answers and appropriate patient selection criteria, which is currently lacking. New literature and societal guidelines that address these concerns may be submitted for reconsideration of the non-coverage policy.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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