CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Stem cell therapy for peripheral arterial disease (PAD) / critical limb ischemia (CLI)

Defines coverage position for use of autologous and allogeneic stem cell therapies (bone marrow–derived, peripheral blood–derived, expanded or concentrated preparations) for treatment of peripheral arterial disease, including critical limb ischemia, for Medicare Advantage and commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyStem cell therapy for peripheral arterial disease (PAD) / critical limb ischemia (CLI)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2026

Next Review Date

Key ActionConfirm member eligibility and coverage limitations via the member's Benefit Booklet, Evidence of Coverage or Subscriber Agreement and contact the provider call center if needed.

POLICY UPDATE CHANGES

No material clinical or coverage changes noted in this update.

3Specific CPT codes not covered / not medically necessary

0Medicare Advantage: covered indications

0Commercial: medically necessary indications

Coverage Summary

This policy defines the coverage position for use of autologous and allogeneic stem cell therapies (including bone marrow–derived, peripheral blood–derived, expanded or concentrated preparations) for treatment of peripheral arterial disease (PAD), including critical limb ischemia (CLI). The policy status is CURRENT with an effective date of 01|01|2026 and last review on 03|18|2026.

The overall coverage stance is mixed: for Medicare Advantage plans the use of injection or infusion of stem cells from concentrated bone marrow, expanded in vitro, stimulated from peripheral blood, or from an allogeneic source is not covered, and for Commercial products these same approaches are considered not medically necessary. The policy concludes the evidence is insufficient to show an improvement in net health outcome for these therapies.

Medical Necessity / Coverage Determinations

Medicare Advantage Plans - Coverage Determination

Treatment is considered not covered when the following technology is used for PAD/CLI:

ALL of the following

Injection or infusion of stem cells from concentrated bone marrow
Injection or infusion of stem cells expanded in vitro
Injection or infusion of stem cells stimulated from peripheral blood
Injection or infusion of stem cells from an allogeneic source

Commercial Products - Medical Necessity Determination

Treatment is considered not medically necessary for PAD/CLI when any of the following stem cell approaches are used:

ANY of the following

Autologous stem cells freshly harvested (including bone marrow aspirate concentrate and similar preparations)
Allogeneic stem cells (pooled or donor-derived mesenchymal stromal cells or other allogeneic products)
Stem cells expanded in vitro
Stem cells stimulated/mobilized from peripheral blood (e.g., GM-CSF–mobilized PBMNC)

Procedures / CPT Codes Not Covered / Not Medically Necessary

The following CPT codes are explicitly not covered (Medicare Advantage) and not medically necessary (Commercial):

Not covered / Not medically necessary CPT codes

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

Not Covered / Experimental Technologies

The policy considers the following autologous and allogeneic stem cell approaches for PAD/CLI to be not covered / not medically necessary: injection or infusion of stem cells from concentrated bone marrow, stem cells expanded in vitro, stem cells stimulated or mobilized from peripheral blood, and stem cells from an allogeneic source.

Specific CPT codes that are explicitly designated as not covered (Medicare Advantage) and not medically necessary (Commercial) are 0263T, 0264T, and 0265T (intramuscular autologous bone marrow cell therapy codes as listed).

Not covered / Not medically necessary CPT codesCPTNot Covered

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

FDA-cleared point-of-care concentration systems (informational)other

DEVICE_LIST

SmartPrep, MarrowStim, PureBMC, Arthrex Angel, Magellan, BioCUE, ART BMC, PXP systems (listed as FDA 510(k) cleared devices)

Provider Actions & Billing Rules

Documentation Required

Refer to benefit booklet / evidence of coverage for member-specific benefits

Benefits may vary between groups/contracts; providers must confirm member eligibility and coverage limitations via the member's Benefit Booklet, Evidence of Coverage or Subscriber Agreement and contact the provider call center if needed.

Billing Rule

Do not bill for non-covered CPT codes without prior member agreement

For services determined not medically necessary or non-covered, providers may not charge the member unless the member was informed and agreed in writing to self-pay in advance; applicable to the listed CPT codes.

0263T
0264T
0265T

Background & Evidence Summary

Peripheral arterial disease (PAD) is an atherosclerotic disorder characterized by narrowing and occlusion of arterial vessels leading to reduced distal perfusion; critical limb ischemia (CLI) is the end stage of lower-extremity PAD with ischemic rest pain, ulcers, and high risk for limb loss. Endogenous compensatory mechanisms include angiogenesis (capillary growth mediated by hypoxia-induced chemokines such as VEGF) and arteriogenesis (collateral vessel enlargement involving migration of bone marrow–derived monocytes), although these processes may be insufficient to restore perfusion in severe disease.

Stem cell–based approaches (autologous bone marrow–derived cells, peripheral blood–derived cells, expanded cell products, and allogeneic mesenchymal stromal cells) have been proposed to augment angiogenesis/arteriogenesis or provide paracrine support to ischemic tissues. The literature primarily consists of phase 2 studies and small randomized controlled trials using a variety of cell preparations and administration routes. Systematic reviews and meta-analyses of these trials have not demonstrated a clear, significant benefit for overall survival, amputation-free survival, or amputation rates, and therefore the evidence base is insufficient to establish a net health benefit.

Meta-analyses and randomized controlled trials have not demonstrated a significant net health benefit of stem cell therapy for PAD/CLI. Systematic reviews and a meta-analysis of trials with the lowest risk of bias found no significant benefit for overall survival, amputation-free survival, or amputation rates; the available RCTs are small, heterogeneous in cell type and delivery route, and additional well-designed, larger randomized trials are needed.

Definitions

Scope / Notes