This is a NON-coverage policy for all platelet-rich plasma (PRP) injections
and/or applications as a means of managing musculoskeletal injuries and/or
joint conditions.

**Introduction**

****

Platelet-rich plasma (PRP) is defined as a platelet-rich concentrate with
platelet levels greater than the baseline platelet count in whole blood. This
autologous derived substance, also referred to as autologous platelet-derived
growth factors (PDGF), platelet gel, platelet-rich concentrate, autogenous
platelet gel, plasma rich in growth factors or platelet releasate, has been
proposed for the treatment of multiple conditions to enhance healing.
Theoretically, these growth factors function as a mitogen for fibroblasts,
smooth muscle cells, osteoblasts and vascular endothelial growth factors.1,2
While PRP may work by activating the innate immune response and stimulating
tissue anabolism, its precise mechanism of action is still unclear.2 The role
that white blood cells (WBCs) may play is particularly unclear, as the immune
cells may act as antimicrobial and/or proinflammatory agents. Furthermore, PRP
preparations are not standardized and exhibit wide variability in platelet and
WBC concentrations and the use of thrombin activators. The way in which
variations in PRP composition may impact clinical outcomes is also unclear.3
Mishra et al.4 proposed classifying these types in 3 categories: the presence
of WBCs (e.g., leukocyte-rich or -poor), whether the PRP is activated or not,
and the concentration of platelets.

A number of factors have contributed to the growing popularity of biologic
therapies despite the dearth of high-quality clinical trials supporting their
use. Musculoskeletal conditions are both serious and prevalent. Conventional
treatment, for the most part, is lacking in success. PRP has the appeal of a
simple, minimally invasive treatment with little regulation, which can be
easily administered via local injection by clinicians. In addition, the
biotechnology companies that manufacture the equipment used to assist in the
production of these therapies have conducted nation-wide marketing directly to
clinicians and consumers, touting success with high profile professional
athletes.

A collection and preparation system is used to collect a small sample of blood
at the patient's point of care or clinical laboratory. The systems used for
preparing autologous PDGF are Federal Drug Administration (FDA) approved under
the 510(k) process. While the technology to obtain PRP is FDA-approved, PRP
itself is currently not indicated for direct injection. Centrifugation of this
blood sample separates the denser red cells from the plasma. The plasma
components are divided into a buffy coat and an adjacent layer. The buffy coat
contains leucocytes and most of the platelets. The adjacent layer of plasma is
less rich in platelets and has few leucocytes.5

There are a variety of techniques used to harvest the buffy coat, the adjacent
plasma layer, or both. Some methods concentrate the buffy coat further using a
"double spin" technique. This process involves a second centrifugation of the
supernatant obtained from the initial centrifugation and produces a more
concentrated sample. Depending on the method used, the number of platelets in
PRP varies between 1 and 9 times that of whole blood. Techniques that produce
higher platelet concentrations (e.g., double spin) typically produce higher
leucocyte concentrations as well. Hence, PRP is often referred to as
leucocyte-rich (LR-PRP) or leucocyte-poor (LP-PRP).6

Some practitioners add exogenous calcium salts to the PRP just prior to
administration with the intention of ensuring platelet activation, while
others assume that contact with tendon collagen will suffice.7 PRP composition
can also differ by donor age, health status, gender and even time of day when
collected.8

Administration protocols also vary per type of injury. PRP may be injected
using a peppering technique, whereby the PRP is injected with several
penetrations of the tendon from a single skin penetration9 or may be injected
directly into a joint. Frequency of injections also vary. For tendon
conditions, 1 to 4 intratendinous injections are given over 2 weeks. Joint
conditions typically have 3 injections given within a 6-month time frame,
usually performed 3-4 weeks apart.10 A local anesthetic is often utilized, and
an ultrasound (US) may provide guidance. Local anesthetics may compromise the
efficacy of the PRP.11 Patients need to refrain from non-steroidal anti-
inflammatory medications for 2 weeks prior to harvesting due to the effect on
platelet function.12 There are no accepted exercise protocols or return-to-
sport guidelines following PRP treatment. The usage of PRP can be broadly
separated into 3 categories which will be discussed further: primary treatment
for tendinopathies/non-tendon inflammation, surgical augmentation of repairs
and primary treatment for osteoarthritis.

**Primary Treatment for Tendinopathies/Non-Tendon Inflammation**

****

The evidence regarding PRP treatment of tendinopathies/non-tendon inflammation
includes multiple randomized control trials (RCT), as well as systematic
reviews with meta-analyses (SR/MA). Typical outcomes are pain relief and
functional status. The literature is clustered around usage for the following:
lateral epicondylitis (LE), carpal tunnel syndrome (CTS), rotator cuff (RC)
tears, plantar fasciitis (PF), Achilles tendinopathy (AT), and patellar
tendinopathy (PT).

Andia2 conducted a review of over 1500 patients treated with PRP for
tendinopathies in 58 studies, evenly distributed between lower and upper
extremities. Six of these were of Level 1 Evidence Quality, mostly utilizing
LR-PRP. Given the heterogeneity in tendinopathies and preparation of PRP, they
concluded the data was insufficient to make a recommendation for treatment.

A 2014 systematic review (SR) of 19 randomized and quasi-randomized trials of
PRP for musculoskeletal soft tissue injuries, involving 1088 participants,
noted no difference in clinically important outcomes.13 The quality of these
studies was limited by small numbers of participants, non-standardization of
treatment preparation and outcome measures that focused on subjective pain
scores, rather than more objective measures of tendon tissue healing or
improvement in function. Additional limitations were lack of accounting for
other confounding factors, such as differentiation between an overuse injury
vs. degenerative tendon rupture, and whether or not bursal involvement was
present. As previously stated, the role of leukocytes in tendon healing is
controversial, but the few randomized trials that differentiated between LR-
PRP and LP-PRP suggest that LR-PRP may be more effective in treatment of
tendinopathies.14 The evidence, examined in detail below, is insufficient to
determine the benefit of PRP on health outcomes for tendinopathies/non-tendon
inflammation.

**Lateral epicondylitis**

LE, commonly known as "tennis elbow", affects approximately 1-3% of the
population with men and women equally represented. An overuse injury is
characterized by angiofibroblastic hyperplasia.15 Patients typically complain
of pain for 6-12 weeks, but in some cases, pain can persist for up to 2 years.
Eighty percent recover with no treatment.16 Although self-limiting, this
condition still results in disability, lost productivity and health care
utilization costs. Conservative efforts include non-steroidal anti-
inflammatory drugs, orthotic devices, physical therapy, glucocorticoid
injection and extracorporeal shock wave therapy.

The Washington State Health Care Authority17 recently published a
comprehensive health technology assessment, in which they examined the
efficacy and safety of PRP when used in the patient with recalcitrant LE (> 6
months duration). The authors included 5 RCTs that compared PRP with
corticosteroid injection (CS)18-22 and 2 RCTs that compared PRP with
anesthetic.9,23 In the short term, neither CS nor local anesthetic differed
from PRP regarding pain or function. While in the intermediate term, low
quality evidence suggested PRP was superior to CS ( _P_ = 0.007) for pain and
function, but not local anesthetic ( _P_ = 0.08). In the long term, low
quality evidence suggested PRP and CS were not different ( _P_ = 0.11), but
PRP was superior to local anesthetic ( _P_ < 0.00001).

Stratification of systematic review/meta-analysis (SR/MA) of 8 RCTs by Mi et
al.24 found that treatment with PRP appeared to be more effective than CS at
intermediate term (12 weeks) and long term (6 months and 1 year) intervals,
whereas CS demonstrated superiority in the short term (2-8 weeks).

Montalvan et al.25 conducted a RCT, which found that 2 US guided PRP
injections in 25 patients were no more efficacious than saline injections at 6
and 12 months on either pain score reduction or functional improvement. Mishra
et al.9 conducted a RCT of 112 patients with LE comparing LR-PRP and
bupivacaine injections, concluding there were no differences in global pain
scores at 12 weeks. Schoffl found no significant difference between PRP vs.
saline in functional improvement at 3 months in a double-blinded (DB) RCT of
50 patients.26

Linnanmaki et al.27performed a parallel group, randomized, controlled
participant- and assessor-blinded study including adults with clinically
diagnosed LE. The participants were recruited from a secondary referral
center, after not responding to initial nonoperative treatment. One hundred
nineteen participants were randomized to receive PRP, saline or autologous
blood. Follow-up visits were at 4, 8, 12, 26, and 52 weeks after the
injection. The primary outcome measure was improvement in pain, measured with
Visual Analog Scale (VAS) in a 0-10 range, without specification as to whether
the pain was activity related or at rest, from baseline to 52 weeks. The
secondary outcomes were the Disabilities of the Arm, Shoulder and Hand (DASH)
score. There were no clinically important differences in the mean VAS pain or
DASH scores among the groups at any timepoint. Level of evidence Level II
therapeutic study.

One small study looked at PRP as an alternative to operative management. Mayo
Clinic28 conducted a non-randomized trial where 15 patients were treated with
a series of 2 LR-PRP injections, and 18 patients were treated with surgery.
Outcome measures included time to pain-free status, time to full range of
motion (ROM), the Mayo Elbow Performance Score (MEPS), and the Oxford Elbow
Score (OES). Successful outcomes were observed in 80% of patients treated with
PRP and 94% of those treated operatively (P = 0.37). A statistically
significant improvement was noted in both time to full ROM (42.3 days for PRP
vs. 96.1 days for surgery; P < 0.01) and time to pain-free status (56.2 days
for PRP vs. 108.0 days for surgery; P < 0.01). No significant difference was
found in return-to-activity rates, overall successful outcomes, MEPS scores,
or OES scores.

Overall, the current evidence suggests that PRP may yield some long-term
benefits that are not apparent before 6 months, particularly when compared
with CS. However, analysis of the quality of evidence is limited by sample
size too small to be sufficiently powered and lack of correction for multiple
comparisons.

**Carpal Tunnel Syndrome**

****

Literature reports comparing 5% Dextrose in Water (D5W), CS and PRP injections
with non-surgical management of CTS were systematically reviewed by Lin et
al.29 Ten studies with 497 patients comparing 5 treatments (D5W, PRP,
splinting, CS, and normal saline (NS)) were included. The main outcome was the
standardized mean difference (SMD) of the symptom severity and functional
status scales of the Boston Carpal Tunnel Syndrome Questionnaire at 3 months
after injections. The results showed that D5W injection was likely to be the
best treatment, followed by PRP injection, in terms of clinical effectiveness
in providing symptom relief. With respect to functional improvement, splinting
ranked higher than PRP and D5W injections. Lastly, CS and saline injections
were consistently ranked fourth and fifth in terms of therapeutic effects on
symptom severity and functional status. D5W and PRP injections are more
effective than splinting and CS or saline injection for relieving the symptoms
of CTS. Compared with splinting, D5W and PRP injections do not provide better
functional recovery.29

In 2009, the UK National Institute for Health and Clinical Excellence (NICE)
stated that current evidence on the safety and efficacy of PRP for
tendinopathy is inadequate in quantity and quality (NICE 2013). This was
reiterated in recent SRs of the evidence.30

**Rotator Cuff Tears**

****

RC tears are a common clinical problem in the geriatric population with rates
as high as 80% in those over age 80,31 and debate exists over how to best
provide pain relief and restore shoulder function. Treatment options can be
broadly divided into non-surgical and surgical, with the majority of patients
initially placed on a trial of conservative therapy. A major concern with RC
repairs in older patients is decreased vascularity and healing potential of
the tendons. With poorer healing, there is an increased risk of re-rupture,
and older age is associated with higher rates of failure following repair. For
those with irreparable RC tears, low functional demand, or interest in
nonoperative management, there are a number of non-surgical treatments to
consider, including rehabilitation and injections of CS, hyaluronic acid (HA)
and PRP.

Several meta-analyses have been published, but none have focused exclusively
on level 1 RCTs until Chen's work.32 Eighteen Level I studies were evaluated.
The VAS scores were significantly improved short term (-0.45 [95% CI, -0.75 to
-0.15]; P < 0.01). Sugaya grade IV and V retears in PRP-treated patients were
significantly reduced long term (odds ratio [OR], 0.34 [95% CI, 0.20-0.57]; P
< 0.01). In PRP-treated patients with multiple tendons torn, there were
reduced odds of retears (OR, 0.28 [95% CI, 0.13-0.60]; P < 0.01). Long-term
odds of retears were decreased, regardless of leukocyte content (LP-PRP: OR,
0.36 [95% CI, 0.16-0.82]; LR-PRP: OR, 0.32 [95% CI, 0.16-0.65]; all P < 0.05)
or usage of gel (non-gel: OR, 0.42 [95% CI, 0.23-0.76]; gel: OR, 0.17 [95% CI,
0.05-0.51]; all P < 0.01). The conclusion was that long-term retear rates were
significantly decreased in patients with RC-related abnormalities who received
PRP. Significant improvements in PRP-treated patients were noted for multiple
functional outcomes, but none reached their respective minimal clinically
important differences. Overall, the results suggest that PRP may positively
affect clinical outcomes, but limited data, study heterogeneity, and poor
methodological quality hinder firm conclusions.

In their double-blind, RCT of 40 patients (average age 51) with RC tears,
Kesikburun et al.33 randomized patients to a single 5-mL injection of either
PRP or saline, in addition to a standard 6-week exercise program. At 1-year
follow-up, the authors found that PRP was no better than placebo at improving
quality of life, pain, disability, and shoulder ROM. In contrast, positive
results were reported by Rha et al.34 in their study of 39 patients (average
age 45) with tendinosis or partial RC tears. Patients were randomized to
either 2 injections of PRP or dry needling spaced 4 weeks apart. At the
6-month follow-up, those treated with PRP had superior results in terms of
pain, function, and ROM.

**Plantar Fasciitis**

****

Singh et al.35 conducted a SR/MA study comparing PRP injections and CS
injections for plantar fasciopathy (PF). Studies were assessed using the
Cochrane Risk of Bias Tool and the Newcastle Ottawa Scale (NOS). The primary
endpoint was pain and function score at 3- and 6-month follow-up. Ten studies
with a total of 517 patients were included. Seven studies were randomized.
Studies reported outcomes using the VAS and American Orthopedic Foot and Ankle
Score (AOFAS). At 3-month follow-up, PRP injections were associated with
improved VAS scores (standard mean difference [SMD], -0.66; 95% CI, -1.3 to
-0.02; p = 0.04) and AOFAS scores (SMD, 1.87; 95% CI, 0.16-3.58; p = 0.03).
However, by the 6-month follow-up, there was no difference in VAS score (SMD,
-0.66; 95% CI, -1.65 to 0.3; p = 0.17) or AOFAS scores (SMD, 1.69; 95% CI,
-1.06 to 4.45; p = 0.23).

Sarah Johnson-Lynn et al.36 randomized 28 patients35 with 6 months or more of
magnetic resonance imaging (MRI)-proven PF to PRP or saline. Using the VAS,
both treatments resulted in a similar, significant improvement in symptoms at
6 months. Levels of Evidence: Level II.

A larger, randomized trial of 115 patients37 compared CS to PRP using Foot
Function Index pain score (FFI). In the control group, FFI pain scores
decreased quickly, and then remained stable during follow-up. In the PRP
group, FFI pain reduction was more modest, but reached a lower point after 12
months than the control group. After adjusting for baseline differences, the
PRP group showed significantly lower pain scores at the 1-year follow-up than
the control group (mean difference, 14.4; 95% CI, 3.2-25.6). The number of
patients with at least 25% improvement (FFI pain score) between baseline and
12-month follow-up differed significantly between the groups. Of the 46
patients in the PRP group, 39 (84.4%) improved at least 25%, while only 20
(55.6%) of the 36 in the control group showed such an improvement (P = 0.003).
The PRP group showed significantly lower FFI disability scores than the
control group (mean difference, 12.0; 95% CI, 2.3-21.6).

**Achilles Tendinopathy**

****

RCTs of 24 patients with injection of PRP vs. saline into Achilles tendon (AT)
demonstrated no significant difference at 3 months in Victorian Institute of
Sports Assessment-Achilles (VISA-A) score.38 A 1-year follow-up of 54 patients
in a similar trial also found no improvement.39

**Patellar Tendinopathy**

****

PT is a condition characterized by anterior knee activity related pain, most
commonly found in athletes who engage in jumping sports. A well-designed
multisite single-blind study randomized 57 athletes with PT to LR-PRP, LP-PRP,
and saline US guided injections. All participants received 1 injection
followed by 6 weeks of supervised rehabilitation training 3 times per week.
Study retention was 93% at 12 weeks and 79% after 1 year. Using the outcome
measure, VISA-P, there was no significant difference in mean change in VISA-P
score, pain, or global rating of change among the 3 treatment groups at 12
weeks or any other time point.40 A SR/MA addressed 70 studies of treatment of
PT involving 2530 patients, reported in 22 studies on eccentric exercise,
extracorporeal shockwave therapy (ESWT), and PRP. Eccentric exercise therapies
obtained the best results (P < 0.05) at short-term (< 6 months, mean 2.7 +/-
0.7 months). However, multiple injections of PRP obtained the best results (P
< 0.05), followed by ESWT and eccentric exercise, at long-term follow-up (>/=6
months, mean 15.1 +/- 11.3 months).41

A different SR looked at 15 studies comparing eccentric training, PRP, CS and
ESWT. Eccentric training, with or without core stabilization or stretching,
improved symptoms by 61% in the VISA-P score with a 95% confidence interval.
Results from ESWT demonstrated 54% improvement and PRP studies 55% improvement
with similar confidence intervals. Finally, CS injection provided no
benefit.42

In summary, findings from RCTs and SR/MA have been mixed and have generally
found that PRP did not have a statistically and/or clinically significant
impact on pain or functional outcomes. In RCTs that have found significantly
improved pain outcomes for PRP injections, important relevancy gaps and study
conduct limitations preclude reaching strong conclusions based on their
findings. The evidence is insufficient to determine the benefit of PRP on
health outcomes for PT.

**Surgical Augmentation of Repairs**

****

The majority of RCTs with surgical repair of RC or AT have not demonstrated
any clinically significant benefit.43-46 A MA of 8 Level I or Level II studies
of RC surgery comparing preoperative and postoperative risk for retears, as
well as, gain in functional outcome showed no statistically significant
differences between those treated with PRP and those without such an
intervention.47 An additional MA of Level II and Level III studies by Saltzman
et al.48 came to similar conclusions. A Cochrane review by Moraes et al.13 on
platelet-rich therapies for musculoskeletal soft tissue injuries identified 2
RCTs and 2 quasi-randomized studies (total n = 203 patients) specifically on
PRP used in conjunction with anterior cruciate ligament (ACL) reconstruction.
Pooled data found no significant difference in International Knee
Documentation Committee (IKDC) scores between the PRP and control groups. The
evidence is insufficient to determine the benefit of PRP on health outcomes
for surgical augmentation of repairs.

**Primary Treatment for Osteoarthritis**

Osteoarthritis (OA) is a common disease involving joint damage, an 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 SRs. Most trials have compared PRP
with HA for knee OA, though HA as a comparator is questionable, because the
evidence demonstrating the benefit of HA for OA is not robust.

****

SRs have generally found that PRP was more effective than placebo or HA in
reducing pain and improving function. However, SR authors have noted that
their findings should be interpreted with caution due to important
limitations, including significant statistical heterogeneity, questionable
clinical significance, and high risk of bias in study conduct.49 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, 6
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.49

A 2014 SR 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 HA 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 6 months post injection. Almost all
trials revealed a high risk of bias.50

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, 6 reported PRP patients to
have significantly less pain at latest follow-up when compared with HA
patients (P < 0.05). Of 6 studies based on the subjective IKDC outcome score,
3 reported PRP patients to have significantly better scores at 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).51

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 3 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
3 groups showed statistically significant improvements in both outcome
measures at 1 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 can provide clinically significant
functional improvement for at least 1 year in patients with mild to moderate
OA of the knee.52

However, evidence is still limited due to overall high risk of bias in
previous trials and great variability between studies regarding the number of
injections (generally 1 to 4), interval between injections, preparation of the
PRP, and volume injected. Furthermore, the typical length of follow up was
only 1 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
as to 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 the present time, the evidence is insufficient to determine
the effects of PRP on health outcomes for OA.

**Primary Treatment for Chronic Low Back Pain**

Low back pain (LBP) is now regarded as the first cause of disability
worldwide, causing morbidity and socioeconomic loss.53 Conventional treatments
include physical therapy, CS injection, medial bundle branch block (MBBB) and
surgery. Intervertebral disc (IVD) degeneration is an important pathogenesis
of LBP. Several animal studies have shown that the injection of PRP into
degenerated IVDs is effective in restoring structural changes (IVD height) and
improving the matrix integrity of degenerated IVDs as evaluated by MRI and
histology.54 Recently, a small number of studies have promoted PRP injection
as a relatively safe means of treating patients with degenerative disc
disease, who have failed other means of managing their LBP. A small number of
prospective trials have suggested there may be some benefit to using PRP
injection in the treatment of pain or functional decline caused by facet joint
arthropathy.55

Forty-seven adults with chronic ( 6 months), moderate-to-severe lumbar
discogenic pain unresponsive to conservative treatment were randomized to
receive intradiscal PRP or contrast agent after provocative diskography. Data
on pain, physical function, and participant satisfaction were collected at 1
week, 4 weeks, 8 weeks, 6 months, and 1 year utilizing Functional Rating Index
(FRI), Numeric Rating Scale (NRS) for pain, the pain and physical function
domains of the 36-item Short Form Health Survey, and the modified North
American Spine Society (NASS) Outcome Questionnaire. Over 8 weeks of follow-
up, there were statistically significant improvements in the 29 participants
who received intradiscal PRP with regards to pain (NRS Best Pain) (P = 0.02),
function (FRI) (P = 0.03), and patient satisfaction (NASS Outcome
Questionnaire) (P = 0.01) compared with controls.56

A non-randomized comparator study by Bise et al.57 looked at the efficacy of
interlaminar computed tomography (CT) guided epidural PRP and CS injections in
60 patients. Utilizing the NRS and for function with the Oswestry Disability
Index (ODI) before and 6 weeks after treatment. At 6 weeks there was found to
be no statistical difference between the 2 groups.

The American Society of Interventional Pain Physicians reviewed the evidence
for PRP usage in LBP. They found Level III evidence for intradiscal injections
of PRP, whereas the evidence is considered Level IV for lumbar facet joint,
lumbar epidural, and sacroiliac joint injections of PRP, (on a scale of Level
I through V) using a qualitative modified approach to the grading of evidence
based on best evidence synthesis.53 The evidence is insufficient to determine
the benefit of PRP on health outcomes for chronic LBP.

The use of autologous biologics to replace or restore damaged tissue is a
relatively new area of medicine that has yet to substantiate its outcomes.53
The American Academy of Orthopedic Surgeons (AAOS) announced at its November
2019 meeting that over the next 5 years, it would prioritize research and
development for biologics to create evidence-based position statements. Their
goals are to establish registries for postmarket monitoring, standardize
reporting requirements and clarify by disease state a consensus approach for
biological markers and clinical trial design.58

PRP is a general term describing a therapy with no gold standard of
preparation or administration technique. This heterogeneity and the small
number of controlled trials make it difficult to assess the efficacy of PRP
for any disorder. There is a lack of standardization of the preparations of
PRP amongst the trials, with varying concentration of platelet, frozen vs.
fresh preparations, and the filtration of white cells. While the body of
evidence of utility for PRP is large, the overall quality of evidence is low.
The studies are relatively small, observational studies, often confounded by
lack of treatment control, precluding cause-and-effect conclusions. RCTs that
compare outcomes in patients whose treatment is standardized are needed to
determine definitive patient selection criteria and clinical utility. The lack
of level I evidence, no clinical practice guideline endorsement, as well as no
commercial coverage, argue strongly against current PRP coverage as reasonable
and necessary for treatment of Medicare patients.

While promising, we believe that there is insufficient high-quality evidence
to justify the use of PRP for the treatment of any condition except for within
the confines of a well-designed clinical trial. Thus, Palmetto GBA considers
PRP injection and PRP combined with stem cells for musculoskeletal injuries
and/or joint conditions, whether primary or adjunctive use, to be experimental
and investigational, because its effectiveness has not been established. PRP
therapy is an evolving area of research. Once PRP preparations are
standardized, trials can more precisely highlight which factors are associated
with better outcomes, yielding more effective PRP preparations and patient
selection criteria. Palmetto GBA will continue to monitor scientific
developments and may adjust this coverage policy in accordance.