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L.2.02.413
Progenitor cell therapy describes the use of multipotent cells of various cell lineages (autologous or allogeneic) for tissue repair and/or regeneration. Progenitor cell therapy is being investigated for the treatment of damaged myocardium resulting from acute or chronic cardiac ischemiaand for refractory angina.
Ischemia
Ischemia is the most common cause of cardiovascular disease and myocardial damage in the developed world. Despite impressive advances in treatment, ischemic heart disease is still associated with high morbidity and mortality. According to the American Heart Association, coronary heart disease has a prevalence of 5.7% among White people, 5.4% among Black people, 8.6% among American Indian/Alaska Native people, and 4.4% among Asian people. For all age strata, the incidence of myocardial infarction is higher in Black males than in Black females, White males, and White females. Heart failure has the highest prevalence among Black males (3.8%) followed by Black females (3.3%), White males (2.9%), Hispanic males (1.8%), Hispanic and White females (both 1.6%), Asian males (1.4%), and Asian females (0.5%). Age-adjusted death rates per 100,000 individuals with coronary heart disease and heart failure are higher for Black males and females than their counterparts of other races.
Treatment
Current treatments for ischemic heart disease seek to revascularize occluded arteries, optimize pump function, and prevent future myocardial damage. However, current treatments do not reverse existing heart muscle damage. Treatment with progenitor cells (i.e., stem cells) offers potential benefits beyond those of standard medical care, including the potential for repair and/or regeneration of damaged myocardium. Potential sources of embryonic and adult donor cells include skeletal myoblasts, bone marrow cells, circulating blood-derived progenitor cells, endometrial mesenchymal stem cells, adult testis pluripotent stem cells, mesothelial cells, adipose-derived stromal cells, embryonic cells, induced pluripotent stem cells, and bone marrow mesenchymal stem cells, all of which can differentiate into cardiomyocytes and vascular endothelial cells for regenerative medicine advanced therapy (RMAT). The RMAT designation may be given if: (1) the drug is a regenerative medicine therapy (ie, a cell therapy), therapeutic tissue engineering product, human cell and tissue product, or any combination product; (2) the drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and (3) preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs.
Multiple progenitor cell therapies such as MyoCell® (U.S. Stem Cell, formerly Bioheart), Ixmyelocel-T (Vericel, formerly Aastrom Biosciences), MultiStem® (Athersys), and CardiAMP™ (BioCardia) are being commercially developed, but none have been approved by the FDA so far.
MyoCell comprises patient autologous skeletal myoblasts that are expanded ex vivo and supplied as a cell suspension in a buffered salt solution for injection into the area of damaged myocardium. In 2017, U.S. Stem Cell reprioritized its efforts away from seeking RMAT designation for MyoCell. The expanded cell product enriched for mesenchymal and macrophage lineages might enhance potency. Vericel has received RMAT designation for Ixmyelocel-T.
MultiStem is an allogeneic bone marrow-derived adherent adult stem cell product that has received RMAT designation.
The CardiAMP Cell Therapy system consists of a proprietary assay to identify patients with a high probability to respond to autologous cell therapy, a proprietary cell processing system to isolate process and concentrate the stem cells from a bone marrow harvest at the point of care, and a proprietary delivery system to percutaneously inject the autologous cells into the myocardium. BioCardia has received an investigational device exemption from the FDA to perform a trial of CardiAMP and is designated as an FDA Breakthrough Device.
Progenitor cell therapy, including but not limited to skeletal myoblasts or hematopoietic cells, is considered investigational as a treatment of damaged myocardium.
Infusion of growth factors (i.e., granulocyte colony stimulating factor [GCSF]) is considered investigational as a technique to increase the numbers of circulating hematopoietic cells as treatment of damaged myocardium.
None
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
7/15/2004: Approved by Medical Policy Advisory Committee (MPAC).
10/5/2004: Code Reference section completed.
3/15/2006: Policy reviewed, no changes.
7/22/2008: Policy reviewed, no changes.
8/10/2009: Policy Title revised to add "Progenitor" and "due to Ischemia," Policy Description Section updated to add research information on various types of autologous cell transplantation and adverse effects of treatment with progenitor cells, Verbiage, "Investigational for all uses," added to Non-Covered ICD-9 Diagnosis codes Section.
07/16/2010: Policy reviewed; no changes.
08/02/2011: Policy reviewed; no changes.
07/17/2012: Policy reviewed. Deleted "Autologous" from the policy title and statement. Deleted outdated references from the Sources section.
09/03/2013: Policy reviewed; no changes.
08/06/2014: Policy reviewed; description updated regarding products. Policy statement unchanged.
08/14/2015: Code Reference section updated for ICD-10.
10/22/2015: Policy description updated. Policy statements unchanged. Investigative definition updated in policy guidelines section.
06/06/2016: Policy number A.2.02.18 added.
01/16/2017: Policy description updated regarding FDA regulation and products. Policy statements unchanged.
08/31/2017: Policy description updated regarding progenitor cell therapies. Policy statements updated to change "hematopoietic stem cells" to "hematopoietic cells."
06/01/2018: Policy description updated regarding product development programs and progenitor cell therapies. Policy statements unchanged.
06/04/2019: Policy reviewed; no changes.
06/12/2020: Policy description updated. Policy statements unchanged.
07/26/2021: Policy reviewed; no changes.
06/08/2022: Policy description updated regarding coronary heart disease and devices. Policy statements unchanged.
06/06/2023: Policy description updated regarding the prevalence of heart failure. Policy statements unchanged.
06/17/2024: Policy reviewed; no changes.
08/28/2024: Policy updated to change the medical policy number from “A.2.02.18” to “L.2.02.413.”
Blue Cross Blue Shield Association policy # 2.02.18
This may not be a comprehensive list of procedure codes applicable to this policy.
There are no specific codes for this procedure, either describing the laboratory component of processing the harvested autologous cells, or for the implantation procedure. The laboratory component may be reported with the stem cell procedure codes (38204, 38206, 38207, 38208, 38209, 38210, 38211, 38212, 38213, 38214, 38215, 38230, 38241). In some situations, the implantation may be an added component of a scheduled coronary artery bypass graft (CABG); in other situations, the implantation may be performed as a unique indication for a cardiac catheterization procedure.
Investigational Codes
Code Number | Description |
CPT-4 | |
HCPCS | |
M0075 | Cellular Therapy |
ICD-10 Procedure | |
ICD-10 Diagnosis |
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