ModifiedUnitedHealthcarePolicy CSNCT0498.05

Prolotherapy and Platelet Rich Plasma Therapies (for North Carolina Only)

Medically necessary determination and coverage stance for prolotherapy and platelet-rich plasma injections for members in North Carolina.

Policy Summary

PayerUnitedHealthcare

PolicyProlotherapy and Platelet Rich Plasma Therapies (for North Carolina Only)

Policy CodePolicy CSNCT0498.05

Change TypeNC Medicaid code coverage notation added

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionWhen billing or authorizing services in North Carolina, verify whether CPT/HCPCS codes 0232T, G0460, G0465, M0076, and P9020 are covered on the NC Medicaid Fee Schedule.

SourceLink

POLICY UPDATE CHANGES

Added notation that CPT/HCPCS codes 0232T, G0460, G0465, M0076, and P9020 are not on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by the State of North Carolina Medicaid Program.

Updated Clinical Evidence and References sections to reflect the most current information.

Archived previous policy version CSNCT0498.04.

2therapies deemed unproven / not medically necessary

NCstate-specific application

severalRCTs & reviews — evidence quality

AAOS/ACR/NICEmajor society guidance cited

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Part 9 of 9policy segments

Coverage Determinations and Evidence Summary

Unproven / Not Medically Necessary

Not medically necessary for any condition

Primary coverage determination: Prolotherapy and platelet-rich plasma (PRP) are considered unproven and not medically necessary for any condition or indication due to insufficient evidence of efficacy.

Refer to the Medical Policy titled Skin and Soft Tissue Substitutes (for North Carolina Only) for related guidance.

Summary of effectiveness across indications

Evidence summarized indicates the following clinical-effectiveness patterns

Knee osteoarthritis evidence: Some systematic reviews and RCTs report modest pain and function improvements with dextrose prolotherapy (DPT) or PRP in knee osteoarthritis (KOA) at 6–12 months, but study quality is low, heterogeneity is high, and a large high-quality RCT found no difference versus saline at 12 months.

See meta-analyses and Bennell et al. RCT for conflicting results.

Lateral epicondylosis evidence: Randomized trials and a large recent RCT (n=231) report that PRP and prolotherapy may provide clinically meaningful improvements in pain and function versus physiotherapy/ESWT at 24 months in chronic lateral epicondylosis.

Large trial shows DASH improvements exceeding MCID at 24 months.

Hand/small-joint evidence: Small RCTs suggest dextrose prolotherapy may be more effective than corticosteroid for first carpometacarpal (thumb CMC) osteoarthritis at longer-term follow-up, but evidence is limited and imprecise.

Data limited to small trials with variable follow-up.

Coverage considerations by condition

Evidence-summary based coverage considerations

Lateral epicondylosis: Some RCTs and meta-analyses indicate dextrose prolotherapy reduces pain and improves function at ~12 weeks compared with active controls, but trials are small and risk of bias is present.12-week benefit reported

Need larger, longer trials; potential needle and exercise confounders.

Rotator cuff tendinopathies: Evidence is mixed: some studies report short-term improvement, while others show worse performance compared with corticosteroid; overall heterogeneity and methodological limitations preclude definitive conclusions for routine coverage.short-term/varied

Not conclusive for routine coverage as proven therapy.

Groin (adductor-related) pain: Very limited data (small studies) suggest possible long-term improvement after prolotherapy, but evidence is weak and insufficient for routine coverage decisions.

Evidence-based coverage considerations

Summary of evidence-based coverage considerations derived from clinical trials and systematic reviews

Temporomandibular joint disorders (TMJ): Dextrose prolotherapy demonstrates short-term pain reduction and some functional improvement across multiple small RCTs and systematic reviews, but evidence is limited by small samples, heterogeneous protocols, and short follow-up; long-term benefit is uncertain.

Quality graded low to moderate in reviews.

Lower limb tendinopathies (Achilles, ankle): Observational studies and small trials suggest potential pain and function improvements with prolotherapy or PRP, but RCT evidence is limited and heterogeneous; safety signals are primarily transient post-injection pain.

Higher-quality RCT data are limited.

Knee osteoarthritis (KOA) — PRP: Evidence for intra-articular PRP in KOA is mixed: meta-analyses report modest benefits at 6–12 months versus placebo or HA in some studies, but a large high-quality RCT showed no significant benefit at 12 months; lack of standardization of PRP formulations limits conclusions.

Benefit may depend on formulation and patient selection; evidence quality low to moderate.

Coverage considerations by indication

Evidence-based findings to inform coverage decisions:

Knee osteoarthritis (KOA) — conditional benefit: Some RCTs and meta-analyses report clinically meaningful improvement in pain and function with PRP at 6–12 months in selected patients, but overall evidence quality is low, results are heterogeneous, and standardization is lacking, so routine coverage is not supported without stronger evidence.

Consider documentation of PRP protocol and prior conservative therapy if evaluated case-by-case.

Hip osteoarthritis: Small, low-quality RCTs and HTAs do not demonstrate consistent clinically meaningful benefit of PRP over placebo or HA up to 6–12 months; evidence is inconclusive.

Routine coverage not supported.

Tendinopathies and patellar tendinopathy: Evidence is mixed across tendinopathies; PRP or prolotherapy may offer short-term symptom relief in some trials but long-term benefits are inconsistent and certainty of evidence is low to very low.

Not routinely supported for broad coverage.

Evidence-based stance (informational)

Evidence summaries: Across conditions, PRP and prolotherapy show short-term pain/function improvements in some settings (e.g., patellar tendinopathy, plantar fasciitis, lateral epicondylitis, selected rotator cuff outcomes), but the body of evidence is heterogeneous, often low or very low certainty, and long-term benefits are inconsistent; adverse events are primarily transient postinjection pain with rare serious events.

See condition-specific sections for study details and limitations.

Foot/Ankle OCL adjunct therapy

Foot/ankle osteochondral lesions — adjunct PRP/HA/bone marrow concentrate findings

Adjunct therapies evidence summary: Systematic reviews of arthroscopic microperforation for talar osteochondral lesions including adjuncts (PRP, HA, bone marrow concentrate) found no statistically significant benefit of adjuncts on key outcome scores overall; small studies reported slight AOFAS score advantages for PRP that did not reach statistical significance.

Further larger studies needed to validate adjunct benefit.

Low back pain

Low back pain — intradiscal, intra-articular, SIJ, ligament and prolotherapy combination studies

Chronic low back pain evidence heterogeneity: Multiple small RCTs and systematic reviews report mixed results for PRP and prolotherapy in chronic low back pain (intradiscal, intra-articular, SIJ, ligament injections); some trials report short- to mid-term improvements in pain or disability but sample sizes are small and follow-up is limited, leaving overall evidence inconclusive.

Comparators include corticosteroid, local anesthetic, radiofrequency, and prolotherapy; larger trials needed.

Chronic wounds

Wound care (DFUs, VLUs, other chronic wounds)

Wound healing evidence summary: Systematic reviews and HTAs indicate PRP may improve healing and complete wound closure for diabetic foot ulcers (moderate to low strength of evidence) but results across chronic wound types are heterogeneous and generally low quality; evidence for venous leg ulcers and other chronic wounds is inconclusive.

Lack of standardized PRP protocols and variable application methods limit generalizability.

Evidence summaries and society guidance

Guidance and evidence summaries relevant to coverage decisions

PRF/PRP wound evidence: Systematic reviews of platelet-rich fibrin (PRF) report many studies supporting soft tissue regeneration and wound healing, but RCT findings are conflicting and appropriate comparative controls are often lacking.

Supports potential efficacy but highlights methodological limitations.

PRP for chronic wounds (DFU): Meta-analyses and HTAs report that PRP may increase complete wound closure in diabetic foot ulcers (moderate to low strength of evidence), but routine use is not uniformly recommended due to heterogeneity and reporting limitations.

See Hayes and ECRI assessments for details.

AAOS guidance: AAOS states PRP may reduce pain and improve function in knee OA based on low-quality evidence, but does not recommend PRP for glenohumeral OA and finds limited evidence for rotator cuff indications.

Guideline-cited limitations include need for better standardization and higher-quality trials.

UnitedHealthcare considers prolotherapy and platelet-rich plasma (PRP) therapies to be not medically necessary for any condition or indication due to insufficient evidence of efficacy. Applicable procedure/HCPCS/CPT codes are provided for reference (e.g., 0232T, G0460, G0465, M0076, P9020); inclusion in the policy does not imply coverage. Note that CPT/HCPCS codes 0232T, G0460, G0465, M0076, and P9020 are not on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by the State of North Carolina Medicaid Program.

Many clinical trials and systematic reviews excluded specific populations that limit generalizability: common exclusions include active knee effusion or infection, recent intra-articular corticosteroid or other influencing injections, and trials often required predefined radiographic grades (e.g., selected Kellgren‑Lawrence grades) or symptom duration thresholds. These entry criteria mean evidence does not directly apply to patients with active effusion, infection, or other excluded clinical features.

Coverage decisions are constrained where evidence is limited by methodological factors: small sample sizes, short follow-up periods (often 12–16 weeks or median follow-up under one year), heterogeneous patient populations, and risk-of-bias concerns. When trials lack adequate size, duration, or consistent outcome reporting, procedures may be considered investigational or excluded from coverage as not proven.

Studies and reviews repeatedly note that PRP preparations are heterogeneous and not standardized. Procedures using nonstandardized PRP formulations or lacking documentation of the PRP preparation method (composition, leukocyte content, activation, platelet/WBC counts) and the indication/protocol used may be excluded or subject to medical review pending submission of standardized preparation details and supporting evidence.

The excerpt does not enumerate explicit population or procedural exclusions beyond the general limitations of the evidence base. However, the policy highlights that lack of standardization in PRP methods and low-quality or heterogeneous evidence are key limitations that inform the overall noncoverage stance.

Within this document excerpt there are no additional explicit procedural or population exclusions specified. The policy instead emphasizes evidence limitations (heterogeneity, small trials, short follow-up) as the basis for noncoverage determinations rather than listing discrete excluded subgroups.

Because the evidence across many wound and spinal indications is heterogeneous, limited in size, and of variable quality, routine use of PRP for numerous wound and spine applications is not uniformly supported. The policy therefore does not endorse routine coverage for these indications and indicates further investigation is needed before clinical usefulness is established.

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, and for knee osteoarthritis PRP should be used only with special arrangements for governance, consent, audit, or research.

Operationally, certain CPT/HCPCS codes referenced in this policy (0232T, G0460, G0465, M0076, P9020) are included for coding reference; however, the policy notes that these codes are not on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by the State of North Carolina Medicaid Program. Providers should confirm state and contractual billing requirements before submission.

UnitedHealthcare's coverage position is that, due to insufficient evidence of efficacy, prolotherapy and platelet-rich plasma therapies are considered unproven and not medically necessary for any condition or indication. The policy cites heterogeneous trial results, variable PRP preparations, and high‑quality RCTs that failed to show benefit in some indications (for example, a large KOA RCT) as the basis for this determination.

For knee osteoarthritis, evidence is inconsistent: some meta-analyses and small trials report modest improvements with dextrose prolotherapy or PRP, but findings are heterogeneous and limited by small sample sizes and short follow-up. A large, high-quality randomized trial did not find a difference between LP-PRP and saline at 12 months, supporting a cautious approach to routine use of dextrose prolotherapy (DPT) or PRP for KOA in the absence of stronger, consistent evidence.

The document repeatedly emphasizes that further investigation is needed before the clinical usefulness of prolotherapy and PRP is proven. Limitations such as small trials, short follow-up, heterogeneity of preparations and protocols, and risk-of-bias concerns mean these therapies remain investigational or not medically necessary outside of well‑controlled research or defined governance arrangements.

A large randomized controlled trial in knee osteoarthritis (Bennell et al., n = 288) found no significant benefit of leukocyte‑poor PRP over saline at 12 months. Other trials have been mixed; taken together, this negative high‑quality trial informs the recommendation that routine PRP use for mild-to-moderate KOA without supportive high‑quality evidence should not be considered standard care.

For hip osteoarthritis and for adjunctive use in rotator cuff surgery, available RCTs and systematic reviews do not demonstrate consistent, clinically meaningful benefit beyond placebo or standard care at short- to mid-term follow-up. Evidence for routine use in these indications remains limited and does not support broad coverage.

For rotator cuff repair adjuncts and related shoulder indications, single small RCTs and systematic reviews report at best small short-term improvements that generally do not persist long term. The body of evidence is low to very low quality and does not support routine use of PRP as a standard adjunct in rotator cuff surgery.

For chronic wounds, including diabetic foot ulcers and venous leg ulcers, systematic reviews and technology assessments report heterogeneous findings: some RCTs suggest PRP may improve healing in diabetic foot ulcers but overall evidence quality is low to moderate and inconsistent. Routine coverage for general chronic wounds is not supported without documented indication, standardized PRP protocol, and evidence of likely benefit.

Major society guidance reflects caution: the American College of Rheumatology/Arthritis Foundation strongly recommends against PRP for knee and hip osteoarthritis and conditionally recommends against prolotherapy for those joints. NICE restricts PRP use to special arrangements and advises against autologous PRP gel for diabetic foot problems outside clinical trials. Other bodies (AAOS, ASIPP, VA/DoD) similarly note limited or low‑quality evidence and recommend research or governance‑controlled use rather than routine adoption.

Procedure and Billing Codes

Applicable procedure/HCPCS/CPT codes (reference)mixed

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 explicit CPT/HCPCS/ICD-10 codes listed in this document sectionmixed

No codes listed

No explicit CPT/HCPCS/ICD-10 codes in this excerptmixed

No codes listed

No codes listed in this document excerptmixed

No codes listed

Affected CPT/HCPCS codes not on NC Medicaid Fee ScheduleCPT|HCPCS

0232T	Notation: CPT/HCPCS code 0232T is not on the State of North Carolina Medicaid Fee Schedule
G0460	Notation: CPT/HCPCS code G0460 is not on the State of North Carolina Medicaid Fee Schedule
G0465	Notation: CPT/HCPCS code G0465 is not on the State of North Carolina Medicaid Fee Schedule
M0076	Notation: CPT/HCPCS code M0076 is not on the State of North Carolina Medicaid Fee Schedule
P9020	Notation: CPT/HCPCS code P9020 is not on the State of North Carolina Medicaid Fee Schedule

Provider Requirements, Prior Authorization, and Documentation

Billing Rule

Code reference and prior‑authorization implication

Applicable procedure and HCPCS/CPT codes listed in this policy are provided for reference only and do not guarantee coverage or payment. Inclusion of codes (for example: 0232T, G0460, G0465, M0076, P9020) does not imply medical necessity. Codes marked with an asterisk (*) are not on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by the State of North Carolina Medicaid Program. Confirm federal, state, and contractual coverage rules and any third‑party authorization requirements before providing services.

Affected example CPT/HCPCS: 0232T, G0460, G0465, M0076, P9020
Codes with * may not be covered by NC Medicaid — verify state fee schedule

Note

No explicit universal prior authorization rules stated

This policy excerpt does not specify a uniform prior authorization rule for prolotherapy or PRP across all UnitedHealthcare products. Local, state, or contractual benefit provisions may impose prior authorization, step therapy, or other utilization management requirements. Verify applicable plan terms and any product‑level medical management tools (e.g., InterQual) that UnitedHealthcare or delegated entities may use.

Clinical Background and Definitions

Prolotherapy — definition

DefinitionInjection of substances (e.g., dextrose, saline, sarapin, procaine, lidocaine, PRP, or autologous stem cell sources) to stimulate local healing and promote growth of ligament or tendon fibers; may be performed as growth-factor injection, growth-factor stimulation, or inflammatory prolotherapy.

PurposeStimulate mild local inflammation to encourage deposition of new ligament or tendon fibers and strengthen weakened structures by directed injections to the injury site.

Formulations includedTraditional agents (dextrose, saline, local anesthetics) as well as newer formulas such as platelet‑rich plasma (PRP) and autologous stem cell sources (bone marrow or adipose-derived).

Typical applicationMultiple, protocolized injections over time to allow gradual tissue buildup and functional restoration.

Platelet‑rich plasma (PRP) — definition

Policy Updates

Policy Summary

PayerUnitedHealthcare

PolicyProlotherapy and Platelet Rich Plasma Therapies (for North Carolina Only)

Policy CodePolicy CSNCT0498.05

Change TypeNC Medicaid code coverage notation added

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionWhen billing or authorizing services in North Carolina, verify whether CPT/HCPCS codes 0232T, G0460, G0465, M0076, and P9020 are covered on the NC Medicaid Fee Schedule.

SourceLink

On This Page

long-term follow-up reported in small studies

Insufficient high-quality comparative trials.

Temporomandibular joint disorders (TMJ): Systematic reviews report prolotherapy reduces TMJ pain versus placebo and may improve mouth opening up to 12 months, but trials are small and heterogeneous.up to 12 months benefits reported

Promising but not definitive; further trials needed.

Surgical augmentation (ACL, meniscal repair): PRP adjuncts show inconsistent short-term benefits and no consistent long-term improvement; current evidence does not support routine use as a surgical adjunct.

Heterogeneous application methods and outcomes reported.

Foot and ankle (Achilles, plantar fasciitis, talus OCL adjunct): PRP is associated with higher rates of transient post-injection pain and a non-negligible complication signal in some reviews (number needed to harm ≈13); adjunct use for talar OCL shows no consistent significant advantage in pooled analyses.

Safety and benefit uncertain; document informed consent if considered.

ACR guidance: ACR/Arthritis Foundation conditionally recommends against prolotherapy for knee/hip OA and strongly recommends against PRP for knee/hip OA.

Supports conservative stance for OA indications.

ASIPP / VA-DoD: ASIPP reports limited to fair evidence for select spinal biologic uses; VA/DoD concludes insufficient evidence to recommend for or against PRP for hip/knee OA due to very low-quality evidence and lack of standardization.

Use of PRP in spine and joint OA remains uncertain.

NICE recommendations: NICE recommends PRP for knee OA only with special arrangements for governance, consent, and audit/research and advises autologous PRP gel not be offered for diabetic foot problems outside clinical trials.

Clinical governance and research arrangements recommended when PRP is used.

No single PA rule stated in this policy — check member contract and state rules
UnitedHealthcare may use third‑party criteria to manage authorization decisions

Prior Authorization

Consider prior authorization for prolotherapy/PRP

Given heterogeneous and inconsistent evidence for prolotherapy and PRP across indications, consider requiring prior authorization to confirm clinical indication, prior conservative therapy trials, and the planned procedure protocol prior to coverage. Prior authorization can help ensure appropriate patient selection and documentation when evidence is limited or mixed.

Use PA to verify indication and prior conservative care when offering prolotherapy/PRP
Require documentation of planned PRP/prolotherapy protocol (preparation and administration)

Prior Authorization

Prior authorization expectations given mixed evidence

Prior authorization decisions for PRP/prolotherapy should reflect the mixed quality of evidence, including large RCTs showing no benefit for some indications (e.g., knee osteoarthritis) and meta‑analyses with heterogeneous results. Expect authorization reviewers to request objective documentation of failure of appropriate conservative measures and justification of use relative to evidence.

PA may require documentation of failed conservative therapies and rationale relating to the evidence base
Large negative RCTs (e.g., KOA) may influence noncoverage or additional scrutiny

Prior Authorization

Prior authorization recommended for PRP

For PRP interventions where evidence is inconsistent (e.g., tendinopathies, KOA, wounds), prior authorization is recommended to require submission of clinical indication, prior conservative therapy failure, and the specific PRP preparation and administration protocol that will be used. Authorization criteria should address lack of standardization in PRP products and protocols.

Require submission of PRP preparation method (leukocyte‑rich vs leukocyte‑poor, platelet counts if available)
Number and timing of planned injections and image guidance or other adjuncts

Documentation Required

Prior authorization documentation to submit

When prior authorization is requested for PRP or prolotherapy, document and submit: diagnosis and severity (including radiographic grading when applicable), prior conservative treatments tried and failed, objective and patient‑reported outcome measures, detailed PRP/prolotherapy protocol, and informed consent that addresses variable evidence and potential for post‑injection pain.

Diagnosis and severity (e.g., Kellgren‑Lawrence grade for KOA) and relevant outcome scores (WOMAC, KOOS, VAS, DASH, PRTEE)
Detailed PRP prep: device/product name (if applicable), leukocyte content, platelet concentration, volume per injection, number and interval of injections
Prior conservative therapies: physical therapy, oral meds, splinting, corticosteroid or hyaluronic acid injections, duration and response
Informed consent addressing heterogeneous evidence and potential for increased transient post‑injection pain

Prior Authorization

Prior authorization recommended for PRP therapies

Due to inconsistent evidence quality, prior authorization may be required for PRP‑based therapies for many indications; when required, PA review should request clinical rationale, documentation of prior conservative therapy trials, and complete PRP protocol information to permit an evidence‑based determination.

PA should verify indication and prior conservative care before approving PRP therapies
Require complete PRP protocol details and follow‑up plan

Billing Rule

Authorization and billing note for affected codes

Billing and authorization note: verify plan, federal/state/contractual obligations and the NC Medicaid fee schedule before authorizing or billing. Codes 0232T, G0460, G0465, M0076, and P9020 are listed for reference; codes marked with an asterisk may not be covered by NC Medicaid.

Confirm whether CPT/HCPCS codes are payable under the member’s plan and state program
Codes with * may not be covered by North Carolina Medicaid — check state fee schedule

Denial Risk

Evidence and trial limitations that may affect authorizations

Evidence limitations that commonly affect authorization include short follow‑up duration, small sample sizes, heterogeneous patient populations, and inconsistent PRP preparation and reporting across studies. These limitations frequently justify additional review and may lead to denial when benefit cannot be established.

Small trials and short follow‑up in many studies limit ability to assess long‑term benefit
Heterogeneity in protocols and populations increases uncertainty for authorization

Documentation Required

Heterogeneity and lack of standardization in PRP

Heterogeneity and lack of standardization in PRP preparations, application methods, and reporting are a persistent concern. Authorization reviewers should request specifics about the PRP product, preparation technique, and administration to evaluate comparability to published evidence.

Document PRP formulation, centrifugation method, platelet concentration, leukocyte content, and device/product identifiers if used
If an FDA‑cleared device or biologic is used, note that device/agent and any manufacturer claims

Denial Risk

Increased post‑injection pain and complication risk — consider in PA

In some indications (notably foot and ankle injections), PRP has been associated with higher rates of transient post‑injection pain and an increased overall complication rate versus comparators. Authorization decisions should weigh these safety signals and may request counseling documentation noting these risks.

Reported higher incidence of treatment‑site pain after PRP (e.g., odds ratio ≈2.23; number needed to harm = 13 in one review)
Documented cases of severe pain requiring surgery are rare but reported

Documentation Required

Record diagnosis severity and trial‑aligned outcome measures

Randomized trials commonly used standardized clinical measures and radiographic grading. For conditions such as knee osteoarthritis, document Kellgren‑Lawrence grade; for functional and symptom assessment include validated instruments (WOMAC, KOOS, VAS, DASH, PRTEE, Timed Up and Go).

Kellgren‑Lawrence grading for KOA where applicable
Patient‑reported outcome scores and performance tests used in trials (WOMAC, KOOS, VAS, DASH, PRTEE, Timed Up and Go)

Documentation Required

Clinical trial‑aligned documentation recommended

Clinical trial protocols often specified the number, timing, and imaging guidance for injections and pre‑ and post‑treatment outcome assessments. Authorization and documentation should align with these elements to allow assessment of whether the planned care matches studied protocols.

Document planned number and interval of injections, use of image guidance, and intended outcome assessment schedule
Provide a plan for objective and patient‑reported follow‑up (e.g., VAS, function scores at defined intervals)

Documentation Required

Documentation that should be included in PA requests

Documentation submitted for authorization should include: diagnosis and severity, prior conservative therapies and duration, objective baseline outcome measures, PRP/prolotherapy preparation and administration details, planned follow‑up and expected outcome measures, and informed consent addressing evidence uncertainty and potential adverse events.

Baseline objective and PRO measures (e.g., VAS, WOMAC, KOOS, DASH)
PRP details: preparation method, leukocyte/platelet data if available, device/product identifiers, number/timing of injections
Prior conservative therapies: type, duration, and response (physical therapy, meds, injections)
Informed consent discussing heterogeneous evidence, uncertain long‑term benefit, and possible increased transient injection pain

Prior Authorization

Prior authorization for regulated products used with procedures

For use of PRP with devices, biologics, or drugs that are subject to FDA regulation, verify coverage and any device‑specific prior authorization or billing requirements. Although PRP and prolotherapy procedures themselves are not FDA regulated, associated products or devices may be.

If using an FDA‑cleared PRP device or an FDA‑regulated biologic/drug as part of the procedure, include device/product identifiers in the PA
Search FDA product codes KSS, ORG, JQC for device info when relevant

Note

Reference contractual/federal/state requirements

When making coverage determinations, always reference federal, state, and contractual plan requirements. This policy is informational; in the event of conflict, the applicable federal, state or contractual requirements govern.

Federal/state/contractual coverage rules supersede this policy when in conflict
Check member‑specific plan terms and state Medicaid fee schedules

Step Therapy

Require evidence of prior conservative therapy in many cases

Some randomized trials enrolled patients only after failure of conservative care (e.g., ≥3 months of nonoperative therapy). Authorization reviewers may require documentation that patients have undergone and failed appropriate first‑line therapies before approving PRP or prolotherapy.

Document duration and type of conservative care tried (e.g., ≥3 months physical therapy, NSAIDs, splinting)
Trials commonly compared PRP to corticosteroid, HA, or placebo — show why PRP is chosen over these alternatives

Step Therapy

Conservative therapy expected before injections

Conservative therapies (oral medications, physical therapy, splinting, corticosteroid injections, hyaluronic acid where applicable) are generally expected as first‑line management. Authorization should verify that conventional therapy has been attempted and documented unless contraindicated.

Document trials of standard therapies and responses prior to PRP/prolotherapy requests
If conservative therapy was not attempted, provide clinical justification for bypassing stepwise care

Autologous blood-derived product with high platelet concentration and platelet-derived growth factors and cytokines intended to stimulate tissue regeneration when injected into low-healing‑potential tissues.

Preparation variabilityPRP preparations are not standardized and exhibit wide variability in platelet and white blood cell concentrations, which may affect clinical outcomes.

Typical useDelivered via intra‑articular or peri‑tendinous injection as an alternative regenerative injectable for osteoarthritis and soft‑tissue conditions.

Regulatory notePRP as a procedure is not FDA‑regulated, though devices or biologics used in preparation may be subject to FDA regulation.

DPT (dextrose prolotherapy) — definition

TermDPT (dextrose prolotherapy)

DefinitionInjection therapy using hypertonic dextrose solution administered intra‑ or peri‑articularly or to entheses to reduce pain and improve function in osteoarthritis and tendinopathies.

Concentrations reportedStudies report various concentrations (e.g., 5%, 15%, 20%, 25%), with differing protocols across trials.

Typical scheduleOften given in a series of injections spaced weeks apart (examples include injections at weeks 0, 3, and 6).

PRP (platelet‑rich plasma) — definition

TermPRP (platelet‑rich plasma)

Core descriptionAutologous plasma concentrated for platelets, containing growth factors and cytokines intended to promote tissue repair when injected locally.

Clinical contextsStudied for knee osteoarthritis, tendinopathies, rotator cuff disease, foot and ankle conditions, and as adjuncts in surgery and wound care.

Evidence limitationsClinical efficacy and safety conclusions are limited by heterogeneity in PRP composition, variable study quality, and inconsistent long‑term data beyond one year.

Dextrose prolotherapy (DPT / HDPT) — definition

TermDextrose prolotherapy (DPT / DPT/HDPT)

DefinitionInjection therapy using hypertonic dextrose solutions (various concentrations reported) intended to stimulate local healing/inflammation in tendinopathies and osteoarthritis.

Efficacy evidenceSystematic reviews and RCTs report short‑term improvements in pain and function in some conditions (e.g., lateral epicondylitis, OA), but trials are often small and heterogeneous.

Common comparatorsCompared with saline, local anesthetic, corticosteroid, exercise, or other conservative measures in trials.

PRP / autologous blood injections — definition

TermPRP / autologous blood injections

DefinitionAutologous blood‑derived injectable therapies (PRP and related products) intended to promote tissue healing; used for musculoskeletal indications and as adjuncts in wound care.

VariabilityMethods of preparation, platelet/WBC concentrations, activation, and application differ widely across studies, affecting comparability.

Clinical findingsSome RCTs show modest benefit versus comparators in selected conditions, but overall evidence quality is low to moderate and heterogeneous.

PRP heterogeneity — definition/implications

ConceptPRP heterogeneity

DescriptionPRP preparations lack standardization across studies with wide variability in platelet and leukocyte concentrations, activation methods, and application techniques.

ImplicationHeterogeneity limits generalizability of trial results and complicates comparison of efficacy and safety across studies.

Recommendation from evidence reviewsAuthors and HTAs note the need for standardized preparation protocols and reporting of composition to interpret outcomes reliably.

LP‑PRP / LR‑PRP — leukocyte‑poor vs leukocyte‑rich PRP variants

VariantsLP‑PRP (leukocyte‑poor) and LR‑PRP (leukocyte‑rich)

DescriptionPRP formulations categorized by leukocyte content; trials reference LP‑PRP and LR‑PRP with potential differences in efficacy and adverse‑event profiles.

Observed differencesSome analyses suggest differing AE profiles (e.g., more local post‑injection pain with certain formulations) and possible variation in clinical response by formulation.

Evidence certaintyComparative data are limited and certainty of differential effects by leukocyte content is low due to heterogeneous reporting.

PRP (platelet‑rich plasma) — additional definitional notes

TermPRP (platelet‑rich plasma)

Alternate descriptionAutologous plasma concentrate with elevated platelet counts delivering growth factors and cytokines; used intra‑articularly or peri‑tendinously across numerous RCTs and meta‑analyses.

Key limitationStudies vary by leukocyte content, concentration, activation, and injection protocol, contributing to inconsistent results across indications.

Typical outcomes measuredPain scores (VAS, WOMAC), functional scores (KOOS, DASH), and healing metrics in wound studies (complete wound closure, time to closure).

DPT (dextrose prolotherapy) — additional notes

TermDPT (dextrose prolotherapy)

Clinical descriptionInjection of hypertonic dextrose (various concentrations) into joints, entheses, or peri‑tendinous tissues aiming to provoke a reparative inflammatory response and improve pain/function in OA and tendinopathy.

Evidence contextSystematic reviews and RCTs (e.g., Hung et al. 2016; Ciftci et al. 2023) report reductions in pain and functional improvements, but heterogeneity and limited trial numbers are common limitations.

Protocol variabilityDextrose concentration, injection frequency, and anatomical targets differ across studies, limiting direct comparisons.

Platelet‑rich fibrin (PRF) — definition

TermPlatelet‑rich fibrin (PRF)

DefinitionAn autologous platelet concentrate used for soft tissue regeneration and wound healing; PRF is related to PRP but prepared differently (fibrin matrix containing platelets).

Evidence summarySystematic reviews report many studies supporting PRF for soft tissue regeneration, but RCT findings are conflicting and appropriate comparative controls are often lacking.

Clinical useStudied as an adjunct in wound care and regenerative procedures; methodologies and controls vary across studies.

Autologous PRP — wound care adjunct definition

TermAutologous PRP (wound care adjunct)

DefinitionPatient‑derived platelet‑rich plasma applied as an adjunct to conventional wound therapy (topical or injection) intended to promote healing in chronic wounds such as diabetic foot ulcers and venous leg ulcers.

Evidence strengthHTAs and systematic reviews report low to moderate strength evidence for DFUs with heterogeneous protocols and inconsistent reporting of PRP composition and outcomes.

Clinical uncertaintyHeterogeneity of preparation and application methods across trials leaves uncertainty about optimal protocols and patient selection who may benefit most.

PRF / PRP — general definition notes

TermPRF / PRP (general)

DefinitionAutologous platelet concentrates used to promote soft tissue regeneration and wound healing; preparation methods, application routes, and controls vary widely across studies.

Evidence noteSome systematic reviews report favorable findings but RCTs and comparative data are often conflicting or low quality, necessitating additional high‑quality trials.

Practical implicationStandardized reporting of preparation protocols, platelet/WBC counts, and application methods is needed to interpret and generalize results.

Prolotherapy — general definition

TermProlotherapy (general)

DefinitionInjection of agents (e.g., hypertonic dextrose, saline, PRP) to stimulate local tissue healing for musculoskeletal pain by inducing a mild inflammatory and reparative response; often considered off‑label use for some agents.

Procedural noteMay be tailored by treating physician to the patient; includes repeated injections to build tissue strength over time.

Regulatory noteThe agents used (e.g., dextrose, lidocaine) are FDA‑approved for injection but not specifically approved for prolotherapy indications; prolotherapy procedures themselves are not FDA‑regulated.

Platelet‑rich plasma (PRP) — bibliographic references

TermPlatelet‑rich plasma (PRP)

DefinitionAutologous blood product concentrated for platelets delivering growth factors and cytokines used intra‑articularly or peri‑tendinously for musculoskeletal conditions.

Evidence caveatSystematic reviews and HTAs highlight heterogeneous study designs, variable PRP formulations, and low to moderate overall evidence quality limiting definitive conclusions.

Representative referencesSee HTAs and meta‑analyses (e.g., Filardo et al. 2021; Hayes 2022) summarized in the policy bibliography.

Dextrose prolotherapy — bibliographic references

TermDextrose prolotherapy

DefinitionInjection of hypertonic dextrose solution around ligaments, tendons, or intra‑articularly intended to stimulate healing and reduce pain; studied in RCTs and meta‑analyses for OA and tendinopathies.

Evidence examplesSystematic reviews (e.g., Hung et al. 2016) and randomized trials (e.g., Lin et al. 2022; Ciftci et al. 2023) report benefits in selected conditions but note heterogeneity and limited trial numbers.

Protocol variabilityDextrose concentrations and injection schedules vary across studies (examples include 5%, 15%, 20%, 25%), limiting cross‑study comparisons.