CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

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

Defines Blue Cross & Blue Shield of Rhode Island's coverage stance for progenitor (stem/progenitor) cell therapies intended to treat damaged myocardium from acute or chronic ischemia and refractory angina, and describes regulatory and evidence context for providers and payers.

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 changes

Effective DateFeb 1, 2017

Next Review DateN/A

Key ActionDo not bill a specific CPT code; file claims with an unlisted CPT code and verify member benefits for coverage determinations.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not medically necessaryCoverage determination

2 RCTsRCT evidence

Unlisted CPTCoding

Tumor/arrhythmia riskAdverse concerns

Coverage Criteria

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General coverage stance

Covered when ALL of the following are met

Policy stance: Progenitor cell therapy (including but not limited to skeletal myoblasts or hematopoietic cells) for treatment of damaged myocardium is considered not medically necessary.

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

Evidence rationale: Available evidence includes small randomized controlled trials and meta-analyses (including 2 RCTs totaling ~200 patients) with inconsistent results and no adequately powered trials demonstrating improvement in clinical outcomes.

High-quality, adequately powered RCTs are needed to determine effects on mortality, major cardiac outcomes, exercise capacity, and quality of life.

Progenitor cell therapy for treatment of damaged myocardium is not medically necessary. This policy excludes the use of progenitor (stem/progenitor) cell treatments aimed at repairing ischemic myocardial damage because available evidence is inadequate to demonstrate improved clinical outcomes.

Specific exclusions include the use of skeletal myoblasts and hematopoietic cells as progenitor cell therapies for damaged myocardium. Also excluded is the infusion of growth factors (eg, granulocyte colony-stimulating factor) when used to increase circulating hematopoietic cells for the purpose of treating damaged myocardium.

Provider Actions & Billing

Prior Authorization

Not applicable

Step Therapy

No step therapy requirements specified in this policy.

Billing Rule

Filing and Benefit Verification

Benefits may vary between groups and contracts. File claims using an unlisted CPT code for procedures related to progenitor cell therapies (no specific CPT exists for processing or implantation). Verify member benefits and coverage terms with the contract/Benefit Booklet, Evidence of Coverage, or Subscriber Agreement prior to services.

File with an unlisted CPT code for procedure and laboratory components when applicable
Verify benefits and medical necessity with the member's contract/Benefit Booklet or Evidence of Coverage

Denial Risk

Not Medically Necessary — Denial Risk

Progenitor cell therapy (including skeletal myoblasts or hematopoietic cells) and infusion of growth factors (e.g., G-CSF) to increase circulating hematopoietic cells for treatment of damaged myocardium are considered not medically necessary. These therapies may be denied as the evidence is insufficient to demonstrate improved health outcomes.

Progenitor cell therapy for damaged myocardium — considered not medically necessary
Infusion of growth factors (e.g., G-CSF) for this indication — considered not medically necessary

Background

Ischemic heart disease can cause irreversible myocardial injury; progenitor cell therapies (autologous or allogeneic multipotent cells) have been investigated as a potential means to repair or regenerate damaged myocardium. However, the evidence base is limited — trials to date have been small, and at least one identified trial was terminated early and was insufficiently powered to evaluate clinical outcomes. Because current data do not show consistent, clinically meaningful benefit, these therapies remain investigational and are considered not medically necessary until larger, adequately powered trials demonstrate improved health outcomes.

Definitions

Progenitor cell therapy — definition and examples (autologous/allogeneic)

DefinitionProgenitor cell therapy: use of multipotent cells (autologous or allogeneic) from various lineages intended for tissue repair or regeneration of damaged myocardium.

Common cell lineages / examplesSkeletal myoblasts; bone marrow–derived cells; circulating blood–derived progenitor cells; mesenchymal stem cells (MSCs); endometrial mesenchymal stem cells; adult testis stem cells.

Sources — autologous vs allogeneicAutologous: donor cells harvested from the same patient (eg, skeletal myoblasts, bone marrow cells). Allogeneic: donor cells from another human donor (eg, bone marrow MSCs from healthy donors).

Delivery methodsDirect intramyocardial injection (thoracotomy), percutaneous intracoronary or catheter-based injection, and intravenous infusion.

Potential mechanisms and risksProposed mechanisms include differentiation/engraftment and paracrine effects (antiapoptotic and proangiogenic cytokines); risks include procedure-related complications, arrhythmias from fibroblast differentiation, and theoretical tumor formation (eg, teratomas).

Regulated cell products — ex vivo expanded/modified examples

DefinitionRegulated cell products: cellular therapies that are expanded or modified ex vivo and therefore subject to FDA regulation and marketing approval.

Examples of regulated productsMyoCell (autologous skeletal myoblasts expanded ex vivo); MyoCell SDF-1 (genetically modified myoblasts to release stromal‑derived factor‑1).

Additional investigational productsProchymal (allogeneic human mesenchymal stem cell product, ex vivo cultured hMSCs); other examples cited include Ixmyelocel‑T and MultiStem (mentioned in brief).

Regulatory noteProducts involving ex vivo expansion or genetic modification (eg, MyoCell, MyoCell SDF‑1, Prochymal) are subject to FDA marketing clearance/approval; autologous cells processed on‑site with existing lab procedures may not require the same clearance pathway.