CurrentBlue Cross Blue Shield - MassachusettsPolicy 348

Stem cell therapy for peripheral arterial disease / critical limb ischemia

This Blue Cross Blue Shield Massachusetts medical policy (Policy #348, BCBSA Ref 8.01.55) governs coverage of stem cell/progenitor cell therapies (autologous and allogeneic, various preparations and routes) for treatment of peripheral arterial disease (PAD) including critical limb ischemia (CLI) for Commercial and Medicare members and specifies prior authorization requirements for inpatient services.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyStem cell therapy for peripheral arterial disease / critical limb ischemia

Policy CodePolicy 348

Change TypeAnnual reviewliterature update (policy unchanged)

Effective Date

Next Review Date

Key ActionPrecertification/preauthorization is required for all products when the stem cell procedure is performed inpatient.

SourceLink

POLICY UPDATE CHANGES

3/2026 annual policy review updated literature through November 24, 2025; reference added; policy statement unchanged.

12/2017 policy statement updated to describe specific sources of stem cells; effective 2017-12-01.

InvestigationalCoverage status for stem cell therapy for PAD/CLI

3Listed CPT codes (informational)

AnnualPolicy review frequency

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This Blue Cross Blue Shield Massachusetts medical policy (Policy #348, BCBSA Ref 8.01.55) governs coverage of stem cell/progenitor cell therapies (autologous and allogeneic, various preparations and routes) for treatment of peripheral arterial disease (PAD) including critical limb ischemia (CLI) for Commercial and Medicare members and specifies prior authorization requirements for inpatient services. Coverage stance: Investigational.

Key policy facts

Coverage statusInvestigational

Listed CPT codes (informational)0263T, 0264T, 0265T

Policy review frequencyAnnual

Last review2026-03-01

Policy number348

Medical-Necessity and Authorization Criteria

Coverage Determination

Policy statement:

Treatment of peripheral arterial disease, including critical limb ischemia, with injection or infusion of stem cells from concentrated bone marrow, expanded in vitro, stimulated from peripheral blood, or from an allogeneic source, is considered INVESTIGATIONAL.

Site-specific prior authorization requirement

Precertification / preauthorization requirements for services described in this policy:

If procedure is performed inpatient: precertification/preauthorization IS REQUIRED for all products.

If procedure is performed outpatient: prior authorization might be required for certain products (refer to payer outpatient prior authorization processes).

Coding

CPT codes considered investigational (included for informational purposes)CPTNot 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.

Inclusion of a code in this policy does not guarantee member coverage or provider reimbursement; providers must verify the member's contract benefits in effect at the time of service and report services using current procedure, revenue, and diagnosis codes (including modifiers) as applicable.

Provider Actions & Authorization Requirements

Prior Authorization

Inpatient precertification required

Precertification/preauthorization is required for all products when the stem cell procedure is performed inpatient.

Prior Authorization

Outpatient prior authorization may be required

For outpatient procedures described by this policy, prior authorization might be required for certain products — provider must check outpatient authorization rules.

Documentation Required

Use up-to-date coding and diagnosis

Providers should report services using current procedure, revenue, and diagnosis codes and include modifiers where applicable; inclusion of codes in policy does not guarantee coverage — verify member contract benefits.

0263T
0264T
0265T

Background and Evidence Summary

The policy summarizes evidence on autologous and allogeneic stem cell therapies for PAD/CLI, noting that the literature consists primarily of small, phase 2 randomized trials, systematic reviews, and meta-analyses. Pooled analyses and meta-analyses have shown no significant benefit for overall survival, amputation-free survival, or amputation rates; published randomized trials (including those using GM-CSF–mobilized peripheral blood mononuclear cells and various bone marrow–derived cell products) have heterogeneous methods and outcomes. The evidence is insufficient to determine an improvement in net health outcome and larger, well-designed RCTs are needed.

Evidence summary

Meta-analyses / RCTsNo significant benefit shown for overall survival, amputation-free survival, or amputation rates in pooled trials; literature primarily phase 2 studies with heterogeneous methods.

Glossary: Critical limb ischemia (CLI) — end stage lower-extremity PAD with severe obstruction resulting in ischemic rest pain, ulcers, and high risk for limb loss. Ankle-Brachial Index (ABI) — index of ankle systolic pressure to brachial systolic pressure (normative range 0.95 to 1.2 mm Hg).