Prolotherapy and Platelet-Rich Plasma (PRP) Therapies (for Tennessee Only)
Medical policy governing coverage for prolotherapy and platelet-rich plasma (PRP) therapies for Tennessee Medicaid and CoverKids members; defines coverage stance and lists applicable billing codes and supporting evidence summaries.
Updated Clinical Evidence and References sections to reflect the most current information
Coverage Determination and Evidence Summary
Unproven / Not Medically Necessary - All indications
Not medically necessary
See related Skin and Soft Tissue Substitutes policy for amnion-derived fluid injections.
Common clinical criteria from trials
Evidence and trial eligibility commonly required:
Derived from RCT inclusion criteria (e.g., Teymouri 2025; Hsieh & Lee 2022)
Reflects step-therapy rationale reported in trials and reviews
Heterogeneity in protocols across studies
Evidence-summary criteria
Evidence-summary coverage considerations based on reported study findings and quality
Multiple systematic reviews and RCTs report variable results and methodological limitations.
Sit et al. 2021 and Bahgat et al. 2025 reported decreased TMJ pain but noted limited sample sizes and short follow-up.
Evidence is suggestive but requires larger, standardized RCTs.
PRP preparations are heterogeneous; routine use for KOA is not supported by consistent high-quality evidence.
Knee osteoarthritis — evidence-based considerations
Evidence summaries from systematic reviews and trials provide mixed results; where benefit is suggested, it is most apparent in mild–moderate KOA and at 6–12 months for some outcomes.
Some meta-analyses reported WOMAC and VAS improvements favoring PRP at 6–12 months but evidence quality is low and results heterogeneous.
Hip osteoarthritis — evidence summary
Available RCTs and reviews are small and low quality; network meta-analysis found no clinically meaningful benefit beyond placebo for most injectables.
Gazendam 2020 and Hayes assessments report no clear benefit beyond placebo in most comparisons.
Tendinopathies and soft-tissue indications
Systematic reviews report mixed and generally low-quality evidence; positive results for some tendinopathies but insufficient or conflicting evidence for others.
Balasubramaniam 2015 and subsequent reviews show potential benefit but call for more RCTs.
ECRI and Lopez-Royo analyses highlight mixed long-term results and limited sample sizes.
Adjunct use in surgical procedures (meniscal repair, ACL reconstruction)
PRP augmentation during arthroscopic meniscal repair or ACL reconstruction has been studied; pooled evidence does not support clear long-term benefit.
Migliorini et al. 2022 found no differences in VAS, Lysholm, IKDC, failure or revision rates.
Hayes and other reviews report low-to-very-low quality evidence and no proven long-term advantage.
Plantar fasciitis
Evidence-summary coverage considerations by condition
Herbert 2024 and other RCTs/meta-analyses report mid-term improvements but note high heterogeneity and variable PRP methods.
Achilles and other foot/ankle conditions
Foot and ankle (Achilles tendinitis, other pathologies)
Fucaloro et al. 2025 reported higher postinjection pain rates; Hayes reviews found limited/inconclusive evidence for Achilles tendinopathy.
Knee
Knee conditions (patellar tendinopathy, ACL reconstruction, other ligament injuries)
Hayes, ECRI, and systematic reviews report low-to-very-low certainty and inconsistent results.
Shoulder
Shoulder (rotator cuff, adhesive capsulitis)
Systematic reviews and HTAs report small short-term benefits but conflicting long-term outcomes and heterogeneity in PRP preparations.
Lateral epicondylitis
Lateral epicondylitis (tennis elbow)
ECRI, Niemiec et al., and Hayes reviews report inconsistent findings, trial heterogeneity, and transient postinjection pain with PRP.
Lateral epicondylitis — mixed/inconclusive evidence
Evidence summaries and systematic reviews across indications — conclusions and limits
Reviews highlight overall poor-quality methodology, heterogeneity, and inconsistent outcome reporting.
Foot/ankle OCLs — limited evidence
Foot/ankle osteochondral lesions and adjuncts to arthroscopic microperforation
Basciani et al. 2024 and Görmeli 2015 report small sample sizes and limited follow-up limiting firm conclusions.
Low back pain — inconsistent supportive evidence
Low back pain — multiple small RCTs and meta-analyses with heterogeneous interventions and mixed outcomes
Network meta-analyses and individual RCTs (e.g., Zhang 2024, Singh 2023, Tuakli-Wosornu 2016) provide conflicting findings and call for larger trials.
Wound care — DFUs: modest/supportive evidence; VLUs/PUs: insufficient
Wounds (DFUs, VLUs, pressure ulcers, other lower-extremity ulcers)
Hayes and ECRI report favorable signals for DFUs but recommend caution due to varied methods and reporting.
ECRI concluded evidence for VLUs is inconclusive; further RCTs with standardized protocols are needed.
Coverage-relevant evidence summaries by indication
Summary of evidence and guideline stances by indication
Qu et al. 2020 and ECRI/HaYes assessments report increased closure but call for standardized protocols and larger multicenter RCTs.
ECRI 2021 found too few data to draw firm conclusions for VLUs and PUs.
Miron et al. 2017 found many supportive clinical studies but conflicting RCT findings.
Guideline statements (AAOS, AAHKS, ACR, NICE, VA/DoD) reflect inconsistent recommendations and limited evidence.
None of the listed indications for prolotherapy or platelet-rich plasma (PRP) are considered medically necessary. UnitedHealthcare has concluded that both therapies are unproven and not medically necessary for any condition or indication due to insufficient evidence of efficacy.
Clinical trial eligibility commonly excludes factors that could confound outcomes. Trials described in the evidence base frequently excluded participants with local infection at the injection site and those with recent corticosteroid or botulinum toxin injections. Many KOA trials enrolled participants meeting specific radiographic grades and symptom duration and applied additional trial-specific exclusion criteria to ensure internal validity.
Some randomized trials explicitly excluded patients who had received recent corticosteroid or botulinum toxin injections. In addition, trials in lateral epicondylosis excluded individuals with complete extensor tendon rupture, reflecting common protocol exclusions meant to avoid enrolling patients with structural conditions unlikely to respond to injection-based regenerative therapies.
There are no uniform procedural or diagnosis exclusions stated in the policy text, but the literature emphasizes that PRP preparations and prolotherapy approaches are not standardized. Variation in product preparation, platelet/leukocyte content, concentrations, volumes, and injection techniques limits comparability across studies and complicates defining explicit procedural exclusions.
Overall evidence is insufficient to support routine use of PRP for many soft-tissue and surgical augmentation indications. Systematic reviews and health-technology assessments describe the available trials as heterogeneous and generally low to very low quality, with inconsistent findings that do not establish clear clinical benefit for most soft-tissue or surgical-augmentation uses.
The policy excerpts do not list specific exclusions for certain ligament injuries; however, systematic reviews and assessments note a lack of evidence for some ligament pathologies (for example, medial collateral ligament injuries) and highlight substantial heterogeneity in PRP protocols that limit generalizability to specific ligament diagnoses.
Although some wound-healing studies show favorable signals for PRP, routine use for wound care is not universally recommended. Reviews and HTAs report benefits in diabetic foot ulcer trials but also note inconsistent methods and reporting; consequently, several assessments do not support routine PRP use for wound care outside of research or well-defined protocols.
The National Institute for Health and Care Excellence (NICE) advises that autologous PRP gel should not be offered for diabetic foot problems unless used within a clinical trial, reflecting caution about routine clinical adoption given current evidence limitations.
This Medical Policy is intended to guide interpretation of standard benefit plans, but federal, state, or contractual benefit plan terms may differ and govern coverage determinations. Providers should verify applicable plan-specific requirements before assuming coverage decisions.
Policy interpretation: on the basis of the totality of evidence summarized in this document, prolotherapy and platelet-rich plasma are considered unproven and not medically necessary for any condition. This determination reflects insufficient, inconsistent, or low-quality evidence across indications and heterogeneous treatment protocols that preclude demonstrating reliable clinical benefit.
Contextual evidence: systematic reviews and some randomized trials report little to no consistent benefit of dextrose prolotherapy (DPT) over normal saline or other comparators for certain indications. Where positive findings exist, they are often from small or methodologically limited studies and are not uniform across the literature.
The evidence base for prolotherapy and PRP is limited and methodologically heterogeneous. Some reviews report worse outcomes for dextrose prolotherapy compared with corticosteroid injections for certain shoulder conditions, and many studies are small, unblinded, or use variable injection techniques and outcome measures.
High-quality randomized evidence in knee osteoarthritis does not demonstrate superiority of PRP over saline placebo in key trials. For example, the Bennell et al. trial found no significant difference in 12‑month pain change or medial tibial cartilage volume between PRP and saline, and other RCTs (e.g., Dório et al.) similarly found no superiority of PRP versus placebo at intermediate follow-up.
For hip osteoarthritis, network meta-analysis and HTA evidence conclude there is no clinically meaningful benefit beyond placebo for most intra-articular injections, and the available RCTs are small and of low quality; combined HA+PRP data are limited and do not establish routine effectiveness.
Routine use of PRP for orthopedic soft-tissue conditions is not supported by consistent, high-quality evidence. Systematic reviews and HTAs report short-term or mixed findings in some settings but overall indicate low to very low certainty and call for well‑designed, larger RCTs with standardized PRP protocols before routine coverage can be endorsed.
An ECRI assessment concluded evidence is inconclusive for venous leg ulcers (VLUs), while systematic reviews and meta-analyses for diabetic foot ulcers (DFUs) show more supportive but heterogeneous results; overall, evidence for chronic wounds varies by wound type and is limited by inconsistent PRP methods and outcome reporting.
Professional society positions vary but generally advise caution. For example, the American Association of Hip and Knee Surgeons does not recommend biologics including PRP for advanced hip/knee arthritis, and other guideline bodies have recommended against routine PRP use for knee and hip osteoarthritis, reflecting limited and low-quality evidence.
Authorization, Documentation, and Billing Guidance
Reference billing codes listed (does not imply coverage)
Included procedure and HCPCS codes are provided for reference only; listing does not imply coverage or guarantee payment. Codes shown in the policy include CPT 0232T (PRP injection), HCPCS G0460 and G0465 (autologous PRP for chronic wounds), M0076 (prolotherapy), and P9020 (PRP, each unit).
- 0232T — Injection(s), platelet rich plasma, any site, including image guidance, harvesting and preparation when performed.
- G0460 — Autologous platelet rich plasma (PRP) or other blood-derived product for nondiabetic chronic wounds/ulcers (per treatment).
- G0465 — Autologous PRP for diabetic chronic wounds/ulcers using an FDA-cleared device (per treatment).
- M0076 — Prolotherapy.
- P9020 — Platelet rich plasma, each unit.
If seeking authorization for prolotherapy, submit diagnosis, prior conservative care, and injectate details
Prior authorization requests for prolotherapy should include clinical documentation of the diagnosis, prior conservative therapies attempted, and details of the planned injectate (for example, concentration and volume) and treatment target (intra‑articular, peri‑articular, or perineural).
- Document diagnosis (e.g., KOA with Kellgren‑Lawrence grade 2–3 where applicable).
- Provide evidence of prior conservative care tried and failed (exercise/physiotherapy, medications, injections as appropriate).
- Specify planned injectate type and protocol (e.g., dextrose concentration/volume, number and interval of injections, route).
No single PA requirement specified in these excerpts — confirm plan-specific rules
The policy excerpts do not state a formal, uniform prior authorization process or explicit mandatory PA forms for all prolotherapy/PRP requests; plan‑specific requirements should be confirmed.
- No explicit universal prior authorization rules are specified in the cited sections.
- Providers should check member-specific plan and state contractual requirements before submission.
No explicit payer prior‑authorization statement present in these excerpts
The evidence summarized shows heterogeneous PRP/prolotherapy preparations and mixed RCT results; however, the excerpts do not present explicit payer-wide prior authorization language in the policy text provided.
- Heterogeneity of preparations and mixed trial outcomes are documented but do not translate to an explicit PA mandate in the cited excerpts.
- Policy language elsewhere may define administrative steps; always verify the full policy text and plan-specific procedures.
When PA is requested for PRP, require indication, failed conservative therapy, and PRP protocol details
If prior authorization is required for PRP, include indication, documentation of failure of conservative therapy, and a detailed PRP protocol (preparation method, platelet/leukocyte content, number/interval of injections).
- State the clinical indication and relevant disease severity (e.g., mild–moderate KOA when applicable).
- Document failed conservative therapies (physical therapy, medications, prior injections) with dates.
- Provide PRP protocol: preparation method, platelet counts or leukocyte‑rich/poor status, volume, activation method, and injection schedule.
Require PA evidence of failed conservative therapy and clinical rationale when conservative care not documented
When conservative care is not documented, require prior authorization to include evidence that standard conservative therapies were attempted and failed and a rationale for PRP use given limited comparative evidence.
- Provide documentation of prior conservative management (e.g., PT, exercise, oral therapies, corticosteroid injection where appropriate) and dates.
- Explain the clinical rationale for PRP/prolotherapy in this patient and reference objective measures or prior outcome measures if available.
PA requirement not specified in these wound‑care excerpts — verify plan/contract terms
No clear, uniform prior authorization mandate is specified in the cited wound‑care and other sections; the document highlights uncertainty and variable protocols that may influence PA decisions at the plan level.
- Cited evidence sections note variability and lack of standardized protocols but do not specify an across‑the‑board PA requirement.
- Verify any PA rules with the member’s benefit plan and state contractual terms.
If PA requested, disclose device/product and PRP preparation details
If PA is required, include device or product identification and PRP preparation details because devices/agents used may be subject to FDA regulation and PRP methods are heterogeneous.
- Identify the PRP device or kit used and whether an FDA‑cleared device is used for the intended indication.
- Document PRP preparation details (platelet concentration, leukocyte content, centrifugation method) and intended use.
Confirm plan‑specific requirements; UHC may use third‑party tools (e.g., InterQual) and contractual terms govern
UnitedHealthcare may use third‑party decision tools (for example, InterQual) and state/contractual benefit terms to administer benefits; check member‑specific plan requirements prior to authorization submission.
- Confirm whether the member’s plan requires additional third‑party criteria or forms (e.g., InterQual).
- Confirm federal, state, or contractual coverage requirements that may govern the decision.
Consider step‑therapy: trial standard conservative therapies before prolotherapy/PRP
Consider requiring a trial of conventional conservative therapies (for example, exercise/physiotherapy, oral analgesics, or corticosteroid injection where appropriate) before authorizing prolotherapy or PRP, consistent with trial populations in the evidence base.
- Document failed trials of standard conservative care, including dates and objective response.
- Consider physical therapy/exercise programs and appropriate medical management as prerequisites before advanced injectables.
Clinical context: PRP/prolotherapy intended for patients refractory to first‑line treatments
PRP and prolotherapy are generally described in the evidence as options for patients refractory to first‑line treatments rather than first‑line therapy; requests should reflect that clinical context.
- Use PRP/prolotherapy primarily for patients who have not responded to conservative care.
- Include prior treatment history demonstrating refractory status in the clinical record.
Document prior failure of conservative therapies—trial populations commonly included refractory patients
Many trials enrolled patients who had failed prior conservative therapies (for example, physiotherapy or shock wave therapy); provide documentation of these prior treatments when requesting PRP/prolotherapy.
- List prior conservative therapies tried and the duration/response for each (e.g., physiotherapy, shock wave therapy).
- Reference study‑like selection criteria when applicable (e.g., refractory after ≥3 months of nonoperative care).
Require trials of standard conservative treatments before PRP in many cases
Guidance from reviews suggests requiring trials of standard conservative treatments (oral medications, physical therapy) and appropriate alternatives (e.g., corticosteroid injection where indicated) before considering PRP.
- Document duration and response to conservative therapies.
- If corticosteroid injections were used, include timing relative to proposed PRP/prolotherapy (many trials excluded recent steroid injections).
For wound indications, document exhaustion of standard wound care before PRP
Consider requiring exhaustion of standard wound care measures (e.g., debridement, off‑loading for diabetic foot ulcers) before PRP for wound indications, consistent with evidence that PRP benefit is primarily shown as an adjunct to standard wound care in DFUs.
- Document prior standard wound care interventions, wound measurements, duration, and response.
- For DFUs, include off‑loading measures and prior local wound therapies applied.
Coding list is for reference only—presence in list does not indicate coverage
List of procedure and diagnosis codes is provided for reference; inclusion of codes in the policy does not imply coverage or guarantee payment—refer to the policy statement that listing does not imply coverage.
- Listing of codes is for reference only and may not be all‑inclusive.
- Benefit coverage is determined by federal, state, or contractual requirements; inclusion does not guarantee reimbursement.
Include diagnosis, failed conservative therapy, treatment route, and injectate details in documentation
When submitting documentation for authorization or review, include diagnosis (for example, KOA with Kellgren‑Lawrence grade when applicable), documentation of failed conservative therapy, treatment approach (intra‑articular vs peri‑articular), and injectate details (concentration, volume, schedule).
- Diagnosis with supporting imaging/grades where relevant (e.g., K‑L grade 2–3 for KOA).
- Prior conservative care attempts and dates.
- Planned treatment technique and injectate specifics (concentration/volume and number of injections).
Document baseline and follow‑up outcome measures (VAS, WOMAC, KOOS, DASH) used in trials
Clinical trial reports and reviews commonly include baseline and follow‑up outcome measures; document baseline scores and planned follow‑up outcome assessments (for example, VAS, WOMAC, KOOS, DASH) to support medical necessity evaluations.
- Record baseline patient‑reported outcome measures (VAS, WOMAC, KOOS, DASH/Q‑DASH, SPADI as applicable).
- Document planned follow‑up assessment timepoints and actual outcome results to mirror trial reporting.
Document PRP composition and preparation method (platelet counts, leukocyte content)
PRP preparation is heterogeneous across studies and is frequently underreported; when documented, include PRP composition (platelet counts, leukocyte content), preparation method, and number/frequency of injections.
- Report platelet concentration and whether PRP is leukocyte‑rich or leukocyte‑poor.
- Document centrifugation/preparation method, activation method if used, and number/interval of injections.
High denial risk: prolotherapy and PRP are considered unproven and not medically necessary
Requests for prolotherapy or PRP are subject to denial because these services are considered unproven and not medically necessary for any condition per the policy; ensure documentation addresses evidence gaps and selection criteria used in trials.
- Policy states prolotherapy and PRP are unproven and not medically necessary for any condition or indication.
- Provide robust, condition‑specific justification and documentation of prior therapies if seeking coverage consideration despite policy stance.
Denial risk increases when evidence shows methodological limitations (small, short, uncontrolled studies)
Methodological limitations commonly cited (small samples, lack of controls, short follow‑up, inconsistent objective outcomes) increase the likelihood of denial if submitted evidence replicates these limitations.
- Document objective measures and longer follow‑up where available to mitigate concerns about small, short trials.
- Address any study‑like limitations in the clinical rationale (e.g., use standardized PRP reporting and validated outcome instruments).
Denial risk: heterogenous PRP methods and limited long‑term/comparative data may lead to denial
Evidence limitations such as heterogeneity of PRP preparation, lack of long‑term follow‑up, and insufficient comparative data are specifically cited as reasons that may lead to medical necessity denial for routine PRP use.
- Provide long‑term outcome data and standardized PRP protocol details when available.
- Comparative evidence demonstrating superiority over standard treatments helps address these limitations.
Requests may be denied if evidence does not show superiority or sustained benefit of PRP
Routine PRP requests may be denied if submitted evidence does not demonstrate superiority or clear long‑term benefit over comparator treatments; include objective comparative data if available.
- Include comparative evidence showing clinical benefit beyond placebo, HA, or corticosteroid where available.
- If relying on evidence from trials, match patient selection and protocol details to those trials showing benefit.
Verify and follow federal, state, or contractual benefit plan requirements; they govern coverage
Coverage decisions must follow applicable federal, state, or contractual benefit plan requirements; this policy is informational and plan‑specific contractual terms govern if there is a conflict.
- Verify the member’s federal, state, or contractual benefit plan terms prior to undertaking treatment or PA submission.
- This Medical Policy supplements but does not supersede plan‑specific contractual requirements.
Procedure and Diagnostic Code References
| 0232T | Injection(s), platelet rich plasma, any site, including image guidance, harvesting and preparation when performed. |
| G0460 | Autologous platelet rich plasma (PRP) or other blood-derived product for nondiabetic chronic wounds/ulcers (includes, as applicable: administration, dressings, phlebotomy, centrifugation or mixing, and all other preparatory procedures, per treatment) |
| G0465 | Autologous platelet rich plasma (PRP) or other blood-derived product for diabetic chronic wounds/ulcers, using an FDA-cleared device for this indication (includes as applicable administration, dressings, phlebotomy, centrifugation or mixing, and all other preparatory procedures, per treatment). |
| M0076 | Prolotherapy. |
| P9020 | Platelet rich plasma, each unit |
| No codes listed |
| No codes listed |
Definitions and Background
Evidence Base and Research Summary
Policy Revision History
Archived previous policy version CS103TN.S; updated Clinical Evidence and References sections to reflect current information.
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