CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

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

This policy governs coverage determinations for progenitor (cell-based) therapies intended to treat damaged myocardium due to acute or chronic ischemia and refractory angina for Blue Cross Blue Shield - Rhode Island 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 change

Effective DateN/A

Next Review DateN/A

Key ActionVerify member benefits and applicable contract language in the Benefit Booklet/Evidence of Coverage prior to service.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredPayer stance

No specific codesCoding guidance

2019-05-11Last review

Phase 2/3 RCTsEvidence base

Coverage Determination and Criteria

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.

ALL of the following

BlueCHiP for Medicare: 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.
BlueCHiP for Medicare: Infusion of growth factors (e.g., granulocyte colony stimulating factor) is considered not covered as a technique to increase the numbers of circulating hematopoietic cells for treatment of damaged myocardium because the evidence is insufficient to determine the effects of the technology on health outcomes.
Commercial: 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.
Commercial: Infusion of growth factors (e.g., granulocyte colony stimulating factor) is considered not medically necessary as a technique to increase the numbers of circulating hematopoietic cells for treatment of damaged myocardium because the evidence is insufficient to determine the effects of the technology on health outcomes.

Denial Risk

Coverage denial risk — Claims for progenitor cell therapy may be denied because therapy is considered not covered/not medically necessary

Claims for progenitor cell therapy or infusion of growth factors for treatment of damaged myocardium may be denied because these therapies are considered not covered (BlueCHiP for Medicare) or not medically necessary (Commercial). Providers should file claims with complete documentation and verify member benefits prior to submission.

Verify member benefits and eligibility before scheduling or performing these procedures.
Include detailed clinical documentation when filing claims to support medical necessity determinations, recognizing the therapies are typically considered not covered/not medically necessary.
Anticipate claim denial for these therapies under the described product lines.

Provider Actions, Billing, and Verification

Prior Authorization

Prior authorization not required — confirm benefits

Prior authorization is not applicable per this policy; however, benefits may vary by contract so verify coverage prior to providing services.

Chunk 3: "PRIOR AUTHORIZATION Not applicable"
Chunk 6: "Benefits may vary between groups contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement"

Documentation Required

Verify benefits and document per contract

Verify member benefits and contract language before service and include any relevant clinical documentation with the claim; consult the member’s Benefit Booklet or Evidence of Coverage for applicable coverage terms.

"Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable not medically necessity /not covered benefits / coverage"

Billing Rule

Claims filing: use unlisted CPT code and verify benefits

Submit claims using an unlisted CPT code because there are no specific CPT codes for cell processing or implantation procedures related to progenitor cell therapy; verify member benefits and contract language prior to service.

"There are no specific codes for this procedure... Claims should be filed with an unlisted CPT code"
"Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement"

Background and Evidence

Progenitor cell therapy describes use of multipotent autologous or allogeneic cells from various lineages intended to repair or regenerate myocardium damaged by acute or chronic ischemia or refractory angina. The intent of these approaches—which may include direct injection of progenitor cells into myocardium or mobilization of hematopoietic cells via growth factor infusion—is to improve cardiac structure or function. However, the evidence base is judged insufficient to establish meaningful improvements in clinical outcomes such as mortality, major cardiac events, exercise capacity, or quality of life, and therefore the therapies are designated not covered (Medicare) or not medically necessary (Commercial) in this policy.

Definitions

Progenitor cell therapy — definition and summary of cell use for myocardial repair

DefinitionUse of multipotent cells of various cell lineages (autologous or allogeneic) intended for tissue repair and/or regeneration of myocardium damaged by acute or chronic ischemia or refractory angina.

Therapeutic intentTo repair or regenerate damaged myocardium and improve cardiac function (e.g., left ventricular ejection fraction) and clinical outcomes such as morbidity and quality of life.

Evidence summaryClinical evidence includes phase 2 and phase 3 randomized controlled trials and multiple meta-analyses; signals for improvements in surrogate endpoints exist but results for clinical outcomes are inconsistent and insufficient.

Policy position (actionable)Progenitor cell therapy for treatment of damaged myocardium is considered not covered (BlueCHiP for Medicare) and not medically necessary (Commercial) due to insufficient evidence to determine effects on health outcomes.

Common cell sources describedIncludes skeletal myoblasts and hematopoietic cells; therapies may also involve infusion of growth factors to mobilize hematopoietic cells.