L29295-LCD

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Local Coverage Determination (LCD) for Transmyocardial Revascularization (L29295)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

LCD Information

Document Information

LCD ID Number L29295

LCD Title

Transmyocardial Revascularization

Contractor's Determination Number 33140

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009

Original Determination Ending Date

Revision Effective Date

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administratice law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-03, Medicare National Coverage Determination, Chapter 1, Section 20.6

Program Memorandum transmittal B-00-31, change request 1210 (Prof 628B)

Indications and Limitations of Coverage and/or Medical Necessity

Transmyocardial Revascularization (TMR) is a surgical technique that uses a laser to bore holes through the myocardium of the heart in an attempt to restore perfusion to areas of the heart not being reached by diseased or clogged arteries. This technique is used as a late or last resort for relief of symptoms of severe angina in patients with ischemic heart disease not amendable to direct coronary revascularization interventions, such as angioplasty, stenting or open coronary bypass.

The precise workings of this technique are not certain. The original theory, upon which the technique was based, that the open channels would result in increased perfusion of the myocardium, does not appear to be the major or only action at work. Several theories have been proposed, including partial denervation of the myocardium or the triggering of the cascade of biological reactions, which encourage increased development of blood vessels.

However, research at several facilities indicates that, despite this uncertainty, the technique does offer relief of angina symptoms for a period of time in patients for whom no other medical treatment offering relief is available. Studies indicate that both reduction in pain and reduction in hospitalizations are significant for most patients treated. Consequently, CMS has concluded that, for patients with severe angina (Class III or IV, Canadian Cardiovascular Society, or similar classification system) for whom all other medical have been tried or evaluated and found insufficient, such therapy offers sufficient evidence of its medical effectiveness to treat the symptomatology. It is important to note that this technique does not provide for increased life expectancy, nor is it proven to affect the underlying cause of the angina. However, it appears effective in treating the symptoms of angina and reducing hospitalizations and allowing patients to resume some of their normal activities of daily living.

Medicare will cover TMR as medically reasonable and necessary when all of the following criteria are met:

• TMR is a late or last resort for patients with severe (Canadian Cardiovascular Society classification of class III or

IV) angina (stable or unstable) which has been found refractory to standard medical therapy, including drug therapy at the maximum tolerated or maximum safe dosages.

• The angina symptoms must be caused by areas of the heart not amendable to surgical therapies such as percutaneous transluminal coronary angioplasty, stenting, coronary atherectomy or coronary bypass.

• Coverage is further limited to those uses of the laser used in performing the procedure which have been approved by the Food and Drug Administration for the purpose for which they are being used

Patients must also meet all of the following selection guidelines

• Have and ejection fraction of 25 % or greater

• Have areas of viable ischemic myocardium (as demonstrated by diagnostic study) which are not capable of being revascularized by direct coronary intervention

• Have been stabilized, or have had maximal efforts to stabilize acute conditions such as severe ventricular arrhythmias, decompensated congestive heart failure or acute myocardial infarction.

The following coverage requirements must also be met:

• Physicians must be properly trained in the procedure.

• Providers of this service must also document that all the ancillary personnel, including physicians, nurses, operating room personnel and technicians, are properly trained in the procedure and the proper use of the equipment involved.

• Providers must have dedicated cardiac care units, including the diagnostic and support services necessary for care of patients undergoing this therapy.

• Providers must conform to the standards for laser safety set by the American National Standards Institute, ANSIZ1363.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

999x Not Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes

33140 TRANSMYOCARDIAL LASER REVASCULARIZATION, BY THORACOTOMY; (SEPARATE PROCEDURE) TRANSMYOCARDIAL LASER REVASCULARIZATION, BY THORACOTOMY; PERFORMED AT THE TIME OF

33141 OTHER OPEN CARDIAC PROCEDURE(S) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY

PROCEDURE)

ICD-9 Codes that Support Medical Necessity

411.1 INTERMEDIATE CORONARY SYNDROME

413.9 OTHER AND UNSPECIFIED ANGINA PECTORIS

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

The medical record documentation must support that the patient meets all of the criteria contained in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy. In addition, the documentation must support that the service was performed. This information is usually found in the history and physical, progress note, operative note, diagnostic test results, and/or discharge summary.

Documentation verifying the laser’s FDA approval, appropriate training of the physician and all ancillary personnel, facility requirements, and that the laser safety standards are being followed must be available at the facility.

Appendices

Utilization Guidelines N/A

Sources of Information and Basis for Decision

Bhimji, S. (2005). Transmyocardial Laser Revascularization. Retrieved from http://www.emedicine.com/med/topic3575.htm on 6/9/2005.

Bridges, C; Horvath, K; et al (2003). The Society of Thoracic Surgeons Practice Guideline Series- Transmyocardial Laser Revascularization. Retrieved from http://www.sts.org/doc/8228 on June 9, 2005.

Cleveland Clinic Heart Center. TMR (Transmyocardial Laser Revascularization) A new surgical procedure for inoperable coronary artery disease patients with angina (chest pain). Retrieved from http://www.clevelandclinic.org/heartcenter/pub/guide/diasease/cad/TMR.htm on June 9, 2005.

Hayden, A. Transmyocardial Revascularization. RN Web [Online]. Available: http://www.rnweb.com/ce/transmyoc.html.

Sanni, A., and Dunning, J (2004). Is transmyocardial revascularization of benefit to people with ‘no option’ angina? Interactive Cardiovascular and Thoracic Surgery 3: 586-592.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number Original

Revision History Explanation Revision Number:Original Start Date of Comment Period:N/A

Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29295) replaces LCD L6654 as the policy in notice. This document (L29295) is effective on 02/02/2009.

Reason for Change