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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules state that osteoarthritis (OA) is a common disease involving joint damage, inadequate healing 
response, and progressive deterioration of the joint architecture. Presently, intra-articular injections of CS or 
viscosupplementation with HA remain the mainstay of conservative treatment. The evidence for using PRP for 
this condition includes multiple RCTs and systematic reviews. Most trials have compared PRP with HA for 
knee osteoarthritis, though HA as a comparator is questionable because the evidence demonstrating the benefit 
of HA for osteoarthritis is not robust. 
Systematic reviews have generally found that PRP was more effective than placebo or HA in reducing pain and 
improving function. However, systematic review authors have noted that their findings should be interpreted 
with caution due to important limitations, including significant statistical heterogeneity, questionable clinical 
significance, and a high risk of bias in study conduct.
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 One retrospective study compared PRP to HA in 190 
patients between January 2014 and October 2017. Western Ontario and McMaster Universities Osteoarthritis 
Index (WOMAC), VAS, and ROM were measured before injection, at 15 days, six months, 12 months, and at 
last follow-up. HA treated patients experienced a higher arthroplasty rate (36.0% vs. 5.3%, p < 0.001), lower 
ROM, worse VAS and WOMAC score, and increased risk of any arthroplasty occurrence (log-rank < 0.001) 
than PRP patients.
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A 2014 systematic review of 10 randomized and non-randomized trials of PRP for OA of the knee found intra-
articular PRP injections were more effective for pain reduction (mean difference (MD) -2.45; 95% CI -2.92 to -
1.98; p-value < 0.00001 and MD -2.07; 95% CI -2.59 to -1.55; p-value < 0.00001, single and double PRP 
injections, respectively) compared with placebo at 6 months post injection. Intra-articular PRP injections were 
compared with hyaluronic acid and showed a statistically significant difference in favor of PRP on pain 
reduction based on the VAS and numeric rating scale (standardized mean difference -0.92; 95% CI -1.20 to -
0.63; p-value <0.00001) at six months post injection. Almost all trials revealed a high risk of bias.
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A similar SR/MA in 2020 of 18 studies (all level 1) met inclusion criteria, including 811 patients undergoing 
intra-articular injection with PRP (mean age, 57.6 years) and 797 patients with HA (mean age, 59.3 years). The 
mean follow-up was 11.1 months for both groups. Mean improvement was significantly higher in the PRP 
group (44.7%) than the HA group (12.6%) for WOMAC total scores (P < 0.01). Of 11 studies based on the 
VAS, six reported PRP patients to have significantly less pain at the latest follow-up when compared with HA 
patients (P < 0.05). Of 6 studies based on the Subjective IKDC outcome score, three reported PRP patients to have significantly better scores at the latest follow-up when compared with HA patients (P < 0.05). Finally, LP-
PRP was associated with significantly better Subjective IKDC scores vs. LP-PRP (P < 0.05).
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Park and colleges
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 conducted an RCT to evaluate the efficacy of inter-articular PRP injections in knee 
osteoarthritis as compared with hyaluronic acid (HA) injection and to determine if clinical efficacy is 
associated with its biological characteristics. This RCT enrolled 110 symptomatic knee osteoarthritis patients 
who received a single injection of leukocyte-rich PRP or HA. Outcomes were assessed at baseline, six weeks, 
three and six months after injection. Authors reported PRP showed significant improvement in IKDC 
subjective scores at six months vs. HA. No significant differences were observed between the clinical outcomes 
in other groups. The proportion of individuals who scored above the minimal clinically important difference 
(MCID) for VAS at six months was significantly greater in the PRP group (P=0.044). Adverse events did not 
differ between the groups. Strengths of this study include RCT design, clearly defined protocol for and PRP 
preparation and administration, and standardized tools for pain assessment. Limitations include lack of placebo 
group and lack of radiological imaging. While it makes valuable contribution comparison to other studies with 
confounders such as leucocyte rich vs. poor, number of injections, type of preparation kit, underlying medical 
conditions, adjunctive therapies were not addressed. 
To address these differences several authors have attempted to use systematic review/meta-analysis approach to 
pool data. Three meta-analysis comparing the literature on the effectiveness and safety of PRP and HA in 
patients with adult knee osteoarthritis were reviewed. Tan et al reviewed twenty-six RCTs with 2430 
individuals and reported PRP significantly reduced patient pain and improved function as comparted to 
HA.
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Chen et al.
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reviewed 14 RTCs comprised of 1350 patients, and Han et al.
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 report on fifteen RCTs 
comprised of 1314 individuals both reporting PRP injections reduced pain more effectively than HA injections. 
All three trials reported no significant difference in adverse events between the two groups. However, meta-
analysis cannot adequately address these factors as they have not been adequately investigated in the trials 
included in the analysis. The fundamental issues as multiple confounders such as the source of stem cells, most 
effective delivery method, role of surgery and type and amount of PRP used are not addressed in high-quality 
studies.
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 This significant heterogeneity subsequently affects the reliability of conclusions. Additionally, 
despite the seemingly large body of evidence, it is important to note that some RCTs were included in multiple 
SR/MAs. 
A recent prospective study compared the efficacy of intra-articular injections of PRP and HA with a control 
group of NS solution for knee OA. This was a randomized, dose-controlled, placebo-controlled, double-blind, 
triple-parallel clinical trial. A total of 87 osteoarthritic knees (53 patients) were randomly assigned to 1 of 3 
groups receiving three weekly injections of either LP-PRP (31 knees), HA (29 knees), or NS (27 knees). 
WOMAC score and IKDC subjective score were collected at baseline and at 1, 2, 6, and 12 months after 
treatment. All three groups showed statistically significant improvements in both outcome measures at one 
month; however, only the PRP group sustained the significant improvement in both the WOMAC score (63.71 
 20.67, increased by 21%) and IKDC score (49.93  17.74, increased by 40%) at 12 months. The conclusion 
was that intra-articular injections of LP-PRP could provide clinically significant functional improvement for at 
least one year in patients with mild to moderate OA of the knee.
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Osteoarthritis of the hip can also be a source of chronic pain. A 2021 double-blind, randomized pilot study of 
leukocyte-poor PRP compared to low-molecular weight hyaluronic acid for symptomatic osteoarthritis of the 
hip was reported on thirty-four patients with hip OA. The patients were randomized to three weekly PRP 
injections or hyaluronic acid, and conversion to total hip arthroplasty or hip resurfacing procedure was the 
primary outcome with pain scores as the secondary outcome. They reported fewer patients converted to 
surgical management and lower pain score in the PRP group (n=19) within six months; however, an additional 
15.8% of the PRP patients with improvements went on the surgical management within the first 
year.
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 Limitations include a sample size too small for statically significant findings, lack of placebo group, 
short-term follow-up, and risk of bias. A 2021 systematic review using GRADE methodology evaluated the effectiveness of PRP in the management of hip OA. Four trials (334 participants, 340 hips) were included, and 
all were marked as moderate risk of bias. PRP's superiority against comparative treatments was reported in 
one study, longer-term evaluations from four to twelve months showed diverse results, and only one study 
reported significantly better results for PRP. The authors recognize considerable heterogenicity and small 
sample sizes among the studies, which were considered moderate to low quality. They conclude while PRP 
may be beneficial and safe for hip OA at mid-term follow-up, further research with high-quality designs, larger 
sample sizes, and comparison to standard treatments are imperative.
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However, evidence is still limited due to the overall high risk of bias in previous trials and great variability 
between studies regarding the number of injections (generally 1 to 4), the interval between injections, 
preparation of the PRP, and volume injected. Furthermore, the typical length of follow up was only one year or 
less. There is also uncertainty regarding whether individuals with less severe OA may benefit more from this 
intervention compared with individuals with more advanced structural damage. Additionally, it is unclear 
whether LR-PRP or LP-PRP should be utilized, though the latter appears to have an advantage. Larger 
controlled studies comparing PRP with placebo and alternatives other than HA are needed to determine the 
efficacy of PRP for knee OA. Further studies are also needed to determine the optimal protocol for delivering 
PRP. At present, the evidence is insufficient to determine the effects of PRP on health outcomes for OA. 
You can find this rule at the Medicare Local Coverage Determination (LCD) L39058: Platelet Rich Plasma 
Injections for Non-Wound Injections. 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.