L29171-LCD

Automated World Health

Local Coverage Determination (LCD) for External Counterpulsation (ECP) (L29171)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29171

LCD Title External Counterpulsation (ECP)

Contractor's Determination Number G0166

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

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 administrative 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: Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 1, Section 20.20

Indications and Limitations of Coverage and/or Medical Necessity

External counterpulsation (ECP), commonly referred to as enhanced external counterpulsation, is a non-invasive method of treatment for coronary artery disease refractory to medical and/or surgical therapy. ECP uses sequential diastolic inflation of lower extremity pneumatic cuffs to augment aortic diastolic pressure, increase venous return to the heart and decrease left ventricular afterload. Augmenting aortic diastolic pressure increases the coronary artery perfusion pressure and transmyocardial pressure gradient possibly enhancing coronary collateral development.

A full course of treatment usually consists of thirty-five (35) one-hour sessions, which may be offered once or twice daily, and covers a period of four to seven weeks.

Coverage beyond a full course of thirty-five (35) one-hour sessions should be rare. Patients are re-evaluated and if there is no angina class improvement after an initial thirty-five (35) hours of treatment, up to ten additional hours of treatment may be covered up until they improve by at least one angina class.

Re-treatment

A repeat full course of treatment may be considered after one year, although this should represent a small percentage of patients.

If within one year, after completion of the initial full course of thirty-five (35) hours of ECP, and the patient meets initial criteria and medical necessity for ECP, an additional course of treatment may be considered.

Medicare will consider ECP medically reasonable and necessary when performed for dates of service on or after July 1, 1999 for patients with disabling stable angina that meet all the following criteria:

• Class III or Class IV angina based on the Canadian Cardiovascular Society Classification scale or an equivalent classification scale.

• Class III is characterized by marked limitation of ordinary physical activity, i.e., walking over two blocks on the level and climbing more than one flight in normal conditions. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.

• Class IV is the inability to carry on any physical activity without discomfort-anginal syndrome may be present at rest. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

• A cardiologist or cardiothoracic surgeon must indicate that the patient is not amenable to surgical intervention, such as percutaneous transluminal coronary angioplasty (PTCA) or cardiac bypass because: their condition is inoperable, or there is a high risk of operative complications or post-operative failure; their coronary anatomy is not readily amenable to such procedures, or; they have co-morbid states which create excessive risk.

This procedure must be performed under direct supervision of a physician. The physician must be present in the office suite and immediately available to provide assistance and direction throughout the time the personnel is performing the service.

The use of hydraulic versions of these treatment devices is noncovered, and therefore will be denied.

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.

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

G0166 EXTERNAL COUNTERPULSATION, PER TREATMENT SESSION

ICD-9 Codes that Support Medical Necessity

413.9 OTHER AND UNSPECIFIED ANGINA PECTORIS

Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

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

Diagnoses that DO NOT Support Medical Necessity

General Information

Documentations Requirements

The medical record documentation maintained in the patient’s file must support that the service was ordered by the physician for a patient with Class III or Class IV angina not amenable to surgical intervention. In addition, the documentation must support that the service was performed and the type of equipment used. This information is usually found in the history and physical, progress notes, and/or hospital/office notes.

The patient’s medical record must include:

• A patient profile that documents previous interventions and their effect in the treatment of angina.

• Patient’s medical history, symptoms, and risk factors.

• ECP record including the patient’s weight, vital signs before, during and after treatment.

• The effect of treatment on the angina, patient’s energy level, skin condition and duration of therapy.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of thirty-five (35) one hour sessions, they may be subject to review for medical necessity.

Sources of Information and Basis for Decision

Arora, R.R., Chow, T.M., Juin, D., Fleishman, B., Crawford, L., McKiernan, T., Nesto, R.W. (1999). The multicenter study of Enhanced external counterpulsation (MUST-EECP) effect of EECP on exercise – induced myocardial ischmeia and anginal episodes. Journal of American College of Cardiology, 33:1833-40. Abstract. This source was used to support indications and limitations for service.

Arora, R.R., Chow, T.M., Juin, D., Fleishman, B., Crawford, L., McKiernan, T., Nesto, R.W., Ferans, C.R., Keller, S. (2002). Effects of enhanced external coutnerpulsation on health related quality of life continue 12 months after treatment substudy of the Multicenter study of enhanced external counterpulsation. Journal Investigative Medicine, 50: 25-32. This source was used to support indications and limitations for service.

Michaels, A.D., Linemaien, G., Soran, O., Kelsey, S.F., Kennard, E.D. (2004). Two year outcomes after enhanced external counterpulsation for stable angina pectoris (from the International EECP Patient Registry [IEPR]). The American Journal of Cardiology (93) 4:453-458. This source was used to support indications and limitations for service.

EECP fact sheet. Vasomedical, Inc. World Wide Web.

Soran, O., Crawford, L., et al. (1999). Enhanced external counterpulsation in the management of patients with cardiovascular disease, Clinical Cardiology, 22, 173-178.

Suresh, K., Simandl, S., et al. (1998). Maximizing the hemodynamic benefit of enhanced external counterpulsation, Clinical Cardiology, 21, 649-653.

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 (L29171) replaces LCD L6492 as the policy in notice. This document (L29171) is effective on 02/02/2009.

Reason for Change