CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Progenitor Cell Therapy for the Treatment of Damaged Myocardium due to Ischemia

This policy states Blue Cross Blue Shield - Rhode Island's coverage stance for progenitor (stem/progenitor) cell therapies and related growth factor infusion when used to treat damaged myocardium from acute or chronic ischemia or refractory angina, for Medicare Advantage and commercial members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyProgenitor Cell Therapy for the Treatment of Damaged Myocardium due to Ischemia

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateJan 2, 2017

Next Review DateJul 17, 2024

Key ActionVerify member-specific benefits and eligibility with the provider call center before billing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not covered / NMNCoverage stance

No FDA-approvedRegulatory status

No CPTCoding

07/17/2024Last review

≥39References

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Not Covered — Medicare Advantage

Medicare Advantage coverage position

Medicare Advantage Not Covered: Progenitor cell therapy, including but not limited to skeletal myoblasts or hematopoietic cells, is considered not covered as a treatment of damaged myocardium because the evidence is insufficient to determine the effects of the technology on health outcomes.

Infusion of growth factors (eg, granulocyte colony-stimulating factor) to increase circulating hematopoietic cells is also considered not covered for this indication.

Not Medically Necessary — Commercial

Commercial product coverage position

Commercial Not Medically Necessary: Progenitor cell therapy, including but not limited to skeletal myoblasts or hematopoietic cells, is considered not medically necessary as a treatment of damaged myocardium because the evidence is insufficient to determine the effects of the technology on health outcomes.

Infusion of growth factors (eg, granulocyte colony-stimulating factor) to increase circulating hematopoietic cells is considered not medically necessary for this indication.

Progenitor cell therapy (including but not limited to skeletal myoblasts or hematopoietic cells) and the use of growth factor infusions (eg, granulocyte colony stimulating factor) to increase circulating hematopoietic cells for treatment of damaged myocardium are not covered or considered not medically necessary. For Medicare Advantage members this therapy is not covered and for Commercial products it is considered not medically necessary due to insufficient evidence demonstrating an effect on health outcomes.

Coverage and eligibility for all services described in this policy are determined by the member's subscriber agreement, member certificate, and/or employer agreement. Those documents supersede the provisions of this medical policy; for member-specific benefits and eligibility contact the provider call center.

For Commercial products, progenitor cell therapy and infusion of growth factors (eg, G-CSF) to increase circulating hematopoietic cells for treatment of damaged myocardium are specifically considered not medically necessary because the evidence is insufficient to determine their impact on health outcomes.

If a service described in this policy is determined to be not medically necessary (or is a medically necessary service that is a non‑covered benefit), the provider may not bill the member unless the member was informed in advance and provided written agreement to assume financial responsibility. Providers should consult their participation agreement(s) for applicable billing provisions.

Coding Guidance

Coding guidanceCPT

unlisted CPT

Claims should be filed with an unlisted CPT code(s) as no specific codes exist for this procedure

Provider Actions & Billing

Prior Authorization

Prior authorization is not applicable for this policy. Benefits may vary by contract — refer to the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable requirements.

Note

Authorization and Benefits Verification

This policy does not guarantee payment. Benefits and eligibility are determined by the member's subscriber agreement, member certificate, or employer agreement which supersede this policy. Providers must obtain member-specific authorization when required by the subscriber agreement or plan.

Obtain member-specific authorization when required by the subscriber agreement or plan.
Contact the provider call center for member-specific benefits and eligibility.

Background

Ischemia is a leading cause of myocardial injury; current standard treatments focus on revascularization, optimization of ventricular function, and prevention of further ischemic events but do not reverse established myocardial muscle loss. Progenitor cell therapies — using various autologous or allogeneic cell types and delivery approaches — have been investigated as a regenerative strategy to repair or regenerate damaged myocardium. Clinical trials and systematic reviews have reported mixed results, with some improvements in surrogate measures (for example, left ventricular ejection fraction) but overall insufficient robust evidence demonstrating consistent improvements in clinically meaningful outcomes.

Definitions

Definition — Progenitor cell therapy

TermProgenitor cell therapy

DefinitionUse of multipotent cells (autologous or allogeneic) from various cell lineages for tissue repair and/or regeneration of damaged myocardium.

Clinical contextInvestigated for treatment of damaged myocardium from acute or chronic ischemia and for refractory angina.

Definition — RMAT

TermRegenerative Medicine Advanced Therapy (RMAT)

DefinitionAn FDA designation for regenerative medicine therapies (including cell therapies, therapeutic tissue engineering products, human cell and tissue products, or combination products) intended to treat serious or life‑threatening conditions when preliminary clinical evidence indicates potential to address unmet medical needs.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyProgenitor Cell Therapy for the Treatment of Damaged Myocardium due to Ischemia

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateJan 2, 2017

Next Review DateJul 17, 2024

Key ActionVerify member-specific benefits and eligibility with the provider call center before billing.

SourceLink

On This Page

Denial Risk

Member Billing & Financial Responsibility

Providers should be aware that if services are determined to be not medically necessary or are non-covered benefits under the member's plan, the provider may not bill the member unless the member was informed and agreed in writing in advance to self-pay. Providers must contact the provider call center for member-specific benefit and eligibility information.

Providers may be financially responsible if the service is not covered by the member's plan.
Obtain written member agreement prior to providing non-covered services if billing the member.

Denial Risk

Coverage Denial Risk

Claims for progenitor cell therapy or infusion of growth factors as treatment for damaged myocardium may be denied or considered not covered/not medically necessary. Review member-specific coverage prior to providing services.

Progenitor cell therapy (including skeletal myoblasts or hematopoietic cells) — not covered (Medicare Advantage) / not medically necessary (Commercial).
Infusion of growth factors (e.g., G-CSF) — not covered (Medicare Advantage) / not medically necessary (Commercial).

Documentation Required

Coding/Documentation Note

There are no specific CPT codes for processing harvested autologous cells or for the implantation procedure. Claims should be filed with an unlisted CPT code(s).

File claims using appropriate unlisted CPT code(s) for the procedure and laboratory processing components.

Example from policyVericel's Ixmyelocel‑T and Athersys' MultiStem have received RMAT designation as noted in the policy.

Progenitor/Stem cell modalities referenced

Autologous bone marrow/blood‑derived mononuclear cellsBone marrow or circulating blood‑derived mononuclear progenitor cells used in intracoronary or intramyocardial delivery approaches.

CD34+ selected cellsAutologous CD34+ stem cell preparations evaluated for refractory angina and ischemic heart disease.

CD133+ selected cellsSelected CD133+ progenitor cells studied to promote angiogenesis in refractory angina (eg, PROGENITOR trial).

Adipose‑derived mesenchymal stromal cellsAllogeneic or autologous adipose tissue‑derived MSCs investigated in chronic ischemic heart failure trials.

Cardiopoietic and combination cell therapiesCardiopoietic cells and combinations (eg, mesenchymal plus c‑kit positive cardiac cells) evaluated in clinical trials for ischemic heart failure.