EMPIRE MEDICARE SERVICES LOCAL COVERAGE DETERMINATION

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Contractor Name
Empire Medicare Services

Contractor Number
00308

Contractor Type
Intermediary

LCD Database ID Number
L534

Contractor’s Determination Number
A05-0002-R5

AMA CPT / ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2005 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS clauses apply. Current Dental Terminology (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

CMS National Coverage Policy

1. Title XVIII of the Social Security Act, Section 1862 (a)(7). This section excludes routine physical examinations
2. Title XVIII of the Social Security Act, Section 1862 (a)(1)(A). This section allows coverage and payment for only those services considered medically reasonable and necessary.
3. Title XVIII of the Social Security Act, Section 1833 (e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.
4. CMS Manual, Publication 100-3, Chapter 1, Section 20.10. This section addresses coverage of cardiac rehabilitation services. (This reference is not available at this time. Please refer to reference in number 5 below)
5. Coverage Issues Manual (CIM), Publication 6, section 35-25. This section addresses coverage of cardiac rehabilitation services.

Primary Geographic Jurisdiction
New York – Entire State
Connecticut
Delaware

Secondary Geographic Jurisdiction
Massachusetts

Oversight Region
02

CMS Consortium
Northeast

DMERC Region LCD Covers
N/A

Original Determination Effective Date
02/01/1995

Revision Effective Date
For services performed on or after 09/01/2004

Indications and Limitations of Coverage and/or Medical Necessity

Cardiac rehabilitation is a comprehensive program of medical evaluation, prescribed exercise, cardiac risk factor modification, education and counseling designed to restore certain patients with coronary heart disease to active and productive lives. Cardiac rehabilitation, as described in the medical literature, is divided into three phases: Phase I is the immediate in hospital post cardiac event phase; Phase II is the outpatient immediate post hospitalization recuperation phase; Phase III is the long term, maintenance phase. This policy encompasses outpatient post hospital cardiac rehabilitation, or Phase II. The program consists of a series of supervised exercise sessions with continuous electrocardiograph monitoring (CEM). Clinically optimal results are obtained if these sessions are conducted three times per week over a 12-week period. Cardiac rehabilitation without continuous EKG monitoring is not covered.

Indications

Cardiac rehabilitation is covered for only three groups of patients:

1. Patients who begin the program within 12 months of an acute myocardial infarction.
2. Patients who are status post coronary artery bypass (CABG) surgery.
3. Patients with chronic stable angina.

Limitations

A. Facilities

Cardiac rehabilitation programs may be provided either by the outpatient department of a hospital or a physician-directed clinic. Coverage for either program is subject to the following conditions:

1. The facility meets the definition of a hospital outpatient department or a physician directed clinic, e.g., a physician is on the premises available to perform medical duties at all times the facility is open, and each patient is under the care of a hospital or clinic physician.

2. The facility has available for immediate use all the necessary cardiopulmonary emergency diagnostic and therapeutic life saving equipment accepted by the medical community as medically necessary, e.g., oxygen, cardiopulmonary resuscitation equipment or defibrillator.

3. The program is conducted in an area set aside for the exclusive use of the program while it is in session.

4. The program is staffed by personnel necessary to conduct the program safely and effectively, who are trained in both basic and advanced life support techniques and in exercise therapy for coronary disease. Services of non-physician personnel must be furnished under the direct supervision of a physician. Direct supervision means that a physician must be in the exercise program area and immediately available and accessible for all emergencies. It does not require that a physician be physically present in the exercise room itself.

5. The non-physician personnel are employees of the physician, hospital or clinic conducting the program and their services are "incident-to" a physician’s professional services.

B. Diagnoses

1. For myocardial infarction, the date of entry into the program must be within 12 months of the date of infarction.

2. For CABG, the initiation of the program should be early enough to have a restorative effect on the recuperative process. Therefore, the date of entry should be within 6 months of the CABG procedure.

3. For angina, all patients must have a pre-entry stress test that is positive for exercise-induced ischemia within 6 months of starting cardiac rehabilitation. A positive stress test in this context implies a junctional depression of 2 mm or more with associated slowly rising ST segment, or 1 mm horizontal or down sloping ST segment depressions. Over the years, nuclear perfusion studies have supplanted standard ECG treadmill tests as a means of evaluating ischemic heart disease, especially for patients who have abnormal rest ECGs. Therefore, the "positive" stress test also includes perfusion studies that demonstrate ischemia.

C. Frequency and duration

1. The frequency and duration of the program are 3 sessions per week over 12 weeks. Sessions extending beyond the 12 weeks will be denied as not medically necessary, unless additional documentation of necessity is demonstrated.

2. Services at a frequency of less than 2-3 sessions per week will be considered not medically necessary.

3. For the purposes of this LCD, Phase II is divided into Phase IIA and Phase IIB. Phase IIA is the initial outpatient cardiac rehabilitation, not to exceed 3 sessions per week in 12 weeks.

Phase IIB consists of an additional series of 36 sessions in 12 weeks and will only be allowed if determined to be medically necessary. The total number of allowable sessions is 72. Phase IIB benefits must meet additional medical necessity criteria, specifically, there must be clear demonstration that the patient is benefiting from cardiac rehabilitation and that the exit criterion below has not been met.

D. Exit criterion

1. This policy establishes an exit criterion to be met when the patient has achieved a stable level of exercise tolerance (7 METS). In the American Heart Association’s functional classification, Class I, or normal function status, begins at 7 metabolic equivalent units (METS). Therefore, completion of 6 minutes of exercise during a treadmill or stress imaging test, utilizing the Bruce protocol, without significant ischemia or dysrhythmia is a reasonable exit criterion.

E. Non-covered diagnoses

1. Use of any ICD-9-CM diagnosis code not in the "ICD-9-CM Diagnosis Codes That Support Medical Necessity" section of this policy will be cause for denial of claims.

Congestive heart failure, post-heart or heart/lung transplant, status post coronary angioplasty and post non-CABG cardiac surgery are not included as covered conditions for cardiac rehabilitation in the Coverage Issues Manual (CIM) 35-25 and cardiac rehabilitation for these conditions is excluded from coverage.

2. A patient with unstable angina will not qualify for cardiac rehabilitation services.

F. Other services

1. Evaluation and management services (E & M), electrocardiograms (ECG) and other diagnostic services may be covered on the day of cardiac rehabilitation if these services are separate and distinct from the cardiac rehabilitation program and are medically necessary.

Forms of counseling, such as dietary counseling and stress management, are not separately reimbursed.

G. Definition of Group Services

1. Group I Services

1. Continuous ECG telemetric monitoring during exercise;
2. ECG rhythm strip with interpretation and physician’s revision of exercise prescription; and
3. Limited examination for physician follows up to adjust medication or other treatment changes.

A visit including one or more of this range of routine services is considered as one routine cardiac rehabilitation visit.

In order for the visit to be reimbursable, at least one of the Group I services must be performed. The same rate of reimbursement would be allowed for each visit, but not all the services need to be performed at each visit.

2. Group II Services

1. New patient comprehensive evaluation, including history, physical and preparation of initial exercise prescription.

One will be allowed at the beginning of the program if not already performed by the patient’s attending physician, or if that performed by the patient’s physician is not acceptable to the program’s director.

2. ECG stress test (treadmill or bicycle ergometer) with physician monitoring and report.

One will be allowed at the beginning of the program and one after 3 months (usually the completion of the program).

3. Other physician services, as needed.

Coverage Topics
Cardiac Rehab Program

Bill Type Codes

Revenue Codes

CPT/HCPCS Codes

1. TRUNCATED DIAGNOSIS CODES ARE NOT ACCEPTABLE.

2. ICD-9-CM code listings may cover a range and include truncated codes. It is the provider’s responsibility to avoid truncated codes by selecting a code(s) carried out to the highest level of specificity and selected from the ICD-9-CM book appropriate to the year in which the service was performed.

3. It is not enough to link the procedure code to a correct, payable ICD-9-CM code. The diagnosis or clinical signs/symptoms must be present for the procedure to be paid. Further, these ICD-9-CM codes can be used only with the conditions listed in the Indications and Limitations sections of this policy.

Diagnoses that Support Medical Necessity
NA

ICD-9-CM Codes that DO NOT Support Medical Necessity
NA

Diagnoses that DO NOT Support Medical Necessity
NA

1. ICD-9-CM diagnosis codes supporting medical necessity must be submitted with each claim. Claims submitted without an appropriate ICD-9-CM diagnosis code will be denied as not medically necessary.

2. All cardiac rehabilitation providers must have in the patient’s medical record documentation of the qualifying event. This information may include copies of the referring physician’s records or reports. A prescription for cardiac rehabilitation from the referring physician must be maintained in the patient’s medical record by the provider of the cardiac rehabilitation service.

3. When billing CPT code 93798, the documentation must clearly indicate that the patient is receiving continuous ECG monitoring.

Utilization Guidelines
NA

1. Medicare Coverage Issues Manual, section 35-25
2. Heart Disease: A Textbook of Cardiovascular Medicine; 5^th edition; edited by Braunwald, Eugene; Chapter 40, Rehabilitation of Patients with Coronary Artery Disease; Dennis, Charles.

Advisory Committee Meeting Notes
This policy does not reflect the sole opinion of the contractor or contractor medical director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups which includes representatives from NA.

Start Date of Comment Period
10/05/1994

End Date of Comment Period
11/20/1994

Start Date of Notice Period
12/01/1994

Revision History Number
5

Revision History

Ted J. Triana, D.O.
Fiscal Intermediary Medical Director

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