Colorado Rocky Mountain Health Plans autologous cellular therapy Coverage Update

Coverage Determination and Evidence Summary

Not medically necessary (general)

Covered when ALL of the following are met:

General coverage determination: Autologous Cellular Therapy is considered unproven and not medically necessary for all indications due to insufficient evidence of efficacy.

Applies to all indications covered by this policy for Ohio.

Summary of evidence-based coverage considerations (informational — reflects evidence strength and uncertainty)

Coverage considerations should reflect the heterogeneous and generally low-to-moderate quality evidence across indications; specific summaries and limitations follow.

Knee osteoarthritis (KOA): Systematic reviews and RCTs show mixed results: some meta-analyses (Dai et al.) found intra-articular MSCs were not superior to placebo for pain or function and treatment effects often did not exceed MCID, while other reviews and cohort series (Prodromos) report improvements; a multisite randomized SVF trial demonstrated dose‑dependent WOMAC improvement to 12 months but had unblinding and attrition limitations. Overall heterogeneity of cell type, dose, processing, and inadequate long-term data limit firm conclusions.

See cited trials and reviews.

Peripheral arterial disease (PAD)/Critical limb ischemia (CLI): Randomized trials and meta-analyses report possible improvements in ulcer healing, ABI, TcPO2, walking distance, and reduced amputation rates in some studies, but many trials are small, heterogeneous, and at risk of bias; Cochrane/Moazzami review could not draw definitive conclusions—larger high-quality RCTs are needed.

Evidence limited and inconsistent.

Musculoskeletal tissue regeneration (tendons, rotator cuff, epicondylitis): Evidence comprises small RCTs and observational studies with mixed results: some studies (e.g., Centeno BMC trial) reported improved PROMs and imaging after BMC and systematic reviews found limited supportive data, but overall risk of bias, lack of standardization, and heterogeneity preclude routine coverage pending further well‑designed RCTs.

Clinical applicability uncertain.

Scleroderma / systemic sclerosis: Available evidence is limited to case series and small trials (including the STAR randomized trial) with low quality and mixed results; some subgroup signals exist but overall data are insufficient to establish safety and efficacy for ADRC/ASC therapies for scleroderma of the hands or face.

Further RCTs required.

Evidence summaries and guideline context

Evidence summaries and professional guideline positions relevant to coverage decisions are summarized below.

Tendon disorders evidence: A systematic review (van den Boom et al. 2020) identified eight trials (289 individuals) with moderate to high risk of bias; while some controlled trials reported superior patient‑reported outcomes and better tendon healing, the reviewers concluded evidence is insufficient for clinical recommendation and warned of unknown serious adverse effects.level 3 evidence

Scleroderma (ADRC/ADSVF/hMSC): Evidence includes case series and the STAR randomized trial (Khanna et al. 2023). STAR showed numeric improvements for ADRC versus placebo but did not meet statistical significance for the full cohort; overall evidence is low quality with high risk of bias and further RCTs are needed.inadequate evidence to establish efficacy

Guideline statements: Multiple professional bodies do not recommend stem cell injections for OA, PAD, or related indications due to insufficient evidence (AAOS: no recommendation; VA/DoD: do not recommend; ESC: not indicated; ISSCR: MSC therapy experimental).

The list of procedure and diagnosis codes included in this policy is provided for reference only. Listing a code does not imply that the service described by the code is a covered health service, nor does it guarantee reimbursement or payment. Benefit coverage is determined by applicable federal, state, or contractual requirements and laws.

Several autologous adipose or tissue-derived interventions have evidence limited to small, uncontrolled case series or cohort reports. Examples include microfragmented adipose tissue (MFAT) for knee osteoarthritis, many tendon applications using bone marrow or adipose-derived products, and adipose‑derived regenerative cell therapies for scleroderma; the available studies are small, lack randomized comparators, and provide very low‑quality evidence with inconsistent outcome measures.

Major professional societies and guideline bodies have not endorsed routine clinical use of stem cell injections for most indications. For orthopedic applications, the AAOS states that injectable biologics such as stem cells cannot be recommended for glenohumeral osteoarthritis and emphasizes the need for higher‑quality standardized evidence. The VA/DoD guideline does not recommend stem cell injections for hip or knee OA. Cardiology guidance from the ESC similarly concludes that angiogenic gene and stem cell therapies are still investigational for chronic limb ischemia. The ISSCR and other organizations characterize many mesenchymal stem cell (MSC) therapies as experimental or lacking sufficient evidence for routine practice.

Overall, autologous cellular therapies are considered unproven for the range of musculoskeletal and related indications reviewed in this policy. The body of evidence is heterogeneous, often at moderate to high risk of bias, and lacks consistent, durable demonstration of clinically meaningful benefit across indications and product types.

Systematic reviews and randomized trials for intra‑articular MSCs in knee osteoarthritis show mixed findings. A meta-analysis of 13 RCTs found no significant difference versus placebo for pain or function and reported that treatment effects often did not exceed the minimum clinically important difference (MCID). Some trials and analyses report benefits versus hyaluronic acid or in uncontrolled cohorts, and a multisite SVF RCT demonstrated dose‑dependent improvements up to 12 months but had methodological limitations (unblinding, attrition). Heterogeneity of cell source, dose, processing, and short follow‑up limit definitive conclusions.

For most musculoskeletal and connective tissue indications the evidence is insufficient and at considerable risk of bias. Systematic reviews of tendon disorders identified trials with moderate–high risk of bias and concluded that current data do not support routine clinical use due to uncertain benefits and unknown serious adverse effects. Similarly, evidence for adipose‑derived therapies in scleroderma is limited to uncontrolled series and small studies; larger randomized controlled trials are needed before these applications can be considered proven or medically necessary.

Procedure and Reference Codes

Applicable procedure codes listedCPT

0263T	Intramuscular autologous bone marrow cell therapy, with preparation of harvested cells, multiple injections, one leg, including ultrasound guidance, if performed; complete procedure including unilateral or bilateral bone marrow harvest.
0264T	Intramuscular autologous bone marrow cell therapy, with preparation of harvested cells, multiple injections, one leg, including ultrasound guidance, if performed; complete procedure excluding bone marrow harvest.
0265T	Intramuscular autologous bone marrow cell therapy, with preparation of harvested cells, multiple injections, one leg, including ultrasound guidance, if performed; unilateral or bilateral bone marrow harvest only for intramuscular autologous bone marrow cell therapy.
0489T	Autologous adipose-derived regenerative cell therapy for scleroderma in the hands; adipose tissue harvesting, isolation and preparation of harvested cells including incubation with cell dissociation enzymes, removal of non-viable cells and debris, determination of concentration and dilution of regenerative cells.
0490T	Autologous adipose-derived regenerative cell therapy for scleroderma in the hands; multiple injections in one or both hands.
0565T	Autologous cellular implant derived from adipose tissue for the treatment of osteoarthritis of the knees; tissue harvesting and cellular implant creation.
0566T	Autologous cellular implant derived from adipose tissue for the treatment of osteoarthritis of the knees; injection of cellular implant into knee joint including ultrasound guidance, unilateral.
0717T	Autologous adipose-derived regenerative cell (ADRC) therapy for partial thickness rotator cuff tear; adipose tissue harvesting, isolation and preparation of harvested cells, including incubation with cell dissociation enzymes, filtration, washing and concentration of ADRCs.
0718T	Autologous adipose-derived regenerative cell (ADRC) therapy for partial thickness rotator cuff tear; injection into supraspinatus tendon including ultrasound guidance, unilateral.
0999T	Autologous muscle cell therapy, harvesting of muscle progenitor cells, including ultrasound guidance, when performed.

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Applicable CPT codes (added)CPT

0999T	CPT code added to policy: Autologous muscle cell therapy, harvesting of muscle progenitor cells, including ultrasound guidance, when performed.
1000T	CPT code added to policy: Autologous muscle cell therapy, administration of muscle progenitor cells into the urethral sphincter, including cystoscopy and post-void residual ultrasound, when performed.
1001T	CPT code added to policy: Autologous muscle cell therapy, injection of muscle progenitor cells into the external anal sphincter, including ultrasound guidance, when performed.

Average interval between ADRC facial procedures — key metric

Average interval between ADRC facial procedures5.30 months (median 6 months; range 3–6.91 months)

Mean (SD) interval5.30 (2.04) months

Median interval6 months

Range of intervals3–6.91 months

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required and Documentation Expectations

Prior authorization is required for autologous cellular therapy per payer rules. Providers must submit a clinical rationale that documents indication, prior nonsurgical conservative care, and detailed procedural information (source of cells, harvest method, processing, dose/volume, number and timing of injections, anatomic target, and any concurrent biologic products). Inclusion of procedure or diagnosis codes in this policy is for reference only and does not imply coverage or payment; prior authorization is still required and determinations are made according to federal, state, or contractual requirements.

Document prior standard nonsurgical care and comparator details from trials (e.g., duration and type of physical therapy, analgesic/anti-inflammatory use, intra-articular corticosteroid or hyaluronic acid injections).
Provide trial protocol details when available: dose groups, harvest and processing methods, number of cells or concentration, adjunctive platelet or growth factor use, and follow-up schedule.
Describe heterogeneity in methods across evidence (cell source — bone marrow vs adipose vs peripheral blood; processing methods — minimal manipulation, enzymatic, microfragmentation; dose and number of injections; OA severity and patient selection) and explain why these differences affect generalizability and comparability.
Include supporting literature or trial reports when claiming benefit, noting whether evidence comes from randomized controlled trials, observational cohorts, or systematic reviews, and summarize key limitations (small sample sizes, short follow-up, attrition, lack of standardized preparation).

Clinical Background and Scope

Autologous cellular therapies use a patient’s own cells — for example, adipose‑derived or bone marrow–derived cells — that are harvested, may be processed or concentrated, and reintroduced to the same individual with the goal of promoting tissue repair. The evidence base includes preclinical studies, case series, and some randomized trials, but remains heterogeneous with methodological limitations, variable processing and dosing methods, and generally limited long‑term outcome data.

Key Terms and Product Definitions

Adipose-Derived Stem Cells (ASCs)

DefinitionMesenchymal adult cells isolated from adipose tissue that can expand in vitro and differentiate into multiple cell lineages.

Typical sourceLiposuction-derived adipose tissue

Clinical use contextStudied as autologous injections or fat‑grafting in facial scleroderma and OA applications

Regulatory noteProcessing methods vary; clinical use typically described in investigational contexts

Autologous Cellular Therapy

DefinitionA therapeutic intervention that uses an individual's stem cells, which can be cultured and expanded outside the body and reintroduced into the donor.

Policy Updates and Effective Dates

2026-04-01policy_revisionLatest

Policy modified and became effective 2026-04-01; CPT codes 0999T, 1000T, and 1001T were added to the list of applicable procedure codes.

Note

Material code additions — 0999T, 1000T, 1001T

The policy notes the addition of CPT codes 0999T, 1000T, and 1001T to the list of applicable codes; providers should be aware these code additions are material changes to the policy's code list.

Added CPT codes: 0999T, 1000T, 1001T

OpenPayer

Autologous Cellular Therapy (for Ohio Only)