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Transmyocardial revascularization (TMR), also known as transmyocardial laser revascularization, is a surgical technique that attempts to improve blood flow to ischemic heart muscle by creating direct channels from the left ventricle into the myocardium. TMR may be performed via a thoracotomy or percutaneous transmyocardial revascularization (PTMR).
Transmyocardial revascularization is performed via a thoracotomy, with the patient under general anesthesia. Cardiopulmonary bypass is not required. A laser probe is placed on the surface of the myocardium, and while the heart is in diastole, the laser is discharged to create a channel through the myocardium into the left ventricle. Less invasive approaches to TMR are also being studied, including port access procedures using novel robotic and thoracoscopic techniques.
TMR can also be performed by the percutaneous route (ie, percutaneous transmyocardial revascularization [PTMR]). PTMR (now being called percutaneous myocardial channeling) is a catheter-based system using holmium:YAG laser revascularization under fluoroscopic guidance. It is performed in Europe, but is not currently approved by the U.S. Food and Drug Administration (FDA). PTMR is performed by interventional cardiologists who create myocardial channels with lasers positioned at the endocardial surface inside the left ventricle. Although less invasive than TMR, there are potential disadvantages to the PTMR approach. To minimize the possibility of cardiac tamponade, a potentially fatal condition in which the pericardium fills with blood, the myocardial channels created by PTMR are not as deep as those made by TMR. Also, positioning the laser under fluoroscopic guidance is less precise than the direct visual control of TMR. Less invasive (e.g., robotic) techniques for use of this procedure are also being studied.
Open TMR has been investigated in 2 populations of patients: 1) patients with ischemic myocardium who are not candidates for other types of revascularization procedures, such as coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty due to anatomic features of their coronary circulation; and 2) patients with areas of ischemic myocardium that are not amenable to surgical revascularization who might benefit from TMR as an adjunct to CABG. Other potential applications of TMR include its use as an adjunct to stem-cell based therapy.
In 1998, the Heart LaserTM was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process for the treatment of patients with stable Class III or IV angina refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis not amenable to direct coronary revascularization. In July 1999, the Eclipse TMR 2000TM was approved by FDA through the premarket approval process for similar indications. Neither device is approved for use as an adjunct to CABG. Use of either device for this purpose would be considered an off-label indication.
POLICYOpen transmyocardial laser revascularization may be considered medically necessary for patients with class III or IV angina, who are not candidates for coronary artery bypass graft (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) surgery who meet ALL of the following criteria:
Open transmyocardial laser revascularization may be considered medically necessary as an adjunct to coronary artery bypass grafting (CABG) in those patients with documented areas of ischemic myocardium that are not amenable to surgical revascularization. This is not separately billable.
Open transmyocardial laser revascularization is considered investigational for all other indications not meeting the above criteria.
Percutaneous transmyocardial laser revascularization is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good 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. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY6/1997: Approved by Medical Policy Advisory Committee (MPAC)
5/1999: Reviewed by MPAC; investigational status upheld
2/2001: Reviewed by MPAC; medically necessary for patients with class III or IV angina, who are not candidates for CABG or PTCA.
5/2001: Reviewed by MPAC; medically necessary as an adjunct to coronary artery bypass grafting (CABG) in those patients with documented areas of ischemic myocardium that is not amenable to surgical revascularization. This is not separately billable.
5/8/2002: Type of Service and Place of Service deleted
5/30/2002: Code Reference section updated
2/25/2004: Canadian Cardiovascular Society (CCS) Functional Classification table deleted
3/25/2004: Reviewed by MPAC, percutaneous transmyocardial laser revascularization considered investigational, "Description" section aligned with BCBSA policy # 7.01.54, investigational definition added to Policy Guidelines, non-covered table added to Code Reference section
5/20/2004: Code Reference section updated, CPT code 33141 moved to non-covered and "Note" description revised (33400-33496, 33542 added, 33572 deleted), ICD-9 diagnosis 413.9 description revised to covered codes, ICD-9 code range 414.00-414.05 listed separately covered codes, CPT 33999 added non-covered codes, ICD-9 procedure 36.32 added non-covered codes
8/28/2006: Policy reviewed, no changes
9/18/2006: Coding updated. ICD9 2006 revisions added to policy.
9/19/2007: Code reference section updated. ICD-9 2007 revisions added to policy. Policy reviewed, no changes
9/19/2008: Annual ICD-9 updates effective 10-1-2008 applied
10/7/2008: Policy reviewed, no changes
06/03/2010: Policy description updated regarding new treatment approaches. Policy statement revised to include criteria to support medical necessity for patients with class III or IV angina, who are not candidates for coronary artery bypass graft (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) surgery. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section. Added ICD-9 codes 411.1 and 414.8-414.9 to the Covered Codes table.
09/23/2011: Policy reviewed; no changes.
09/27/2012: Policy reviewed; no changes.
10/22/2013: Policy reviewed; no changes to policy statement. Moved CPT code 33141 from the Investigational Codes table to the Covered Codes table based on policy statement.
09/30/2014: Policy reviewed; description updated. Added the following policy statement: Open transmyocardial laser revascularization is considered investigational for all other indications not meeting the above criteria.
09/01/2015: Code Reference section updated for ICD-10.
10/27/2015: Policy description updated. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.
03/31/2016: Policy description updated. Policy statements unchanged.
05/31/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.54
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.