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Instructions for Accessing LCDs. J4 LCD List

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As a contractor, TrailBlazer oversees LCD development and reconsideration. More information is available on the LCD Development Process and the steps involved in the LCD Reconsideration Process at these links.

Consolidation of LCDs for the J4 MAC (Colorado, New Mexico, Oklahoma and Texas) is complete. TrailBlazer will review all comments received, although not required, as there is no formal comment period.

The LCDs indicate a status of "F" for the required notice period (minimum of 45 days) and are available for review December 20, 2007.

LCDs are identical for all states in the jurisdiction but will not be effective until each state’s cutover date. These will not apply to services rendered prior to the final J4 cutover dates approved by CMS. The

tentative cutover dates, unless further notified by CMS, are as follows:

z March 1, 2008 – New Mexico Part B; Oklahoma Part A and Part B. z March 21, 2008 – Colorado Part B.

z June 13, 2008 – Colorado Part A; New Mexico Part A; Texas Part A and Part B.

Providers may submit questions or comments concerning Local Coverage Determinations via e-mail at policy@trailblazerhealth.com.

Instructions for Accessing LCDs

J4 LCD List

Draft Status Key:

A: Active policy; notice period complete and the policy is in effect C: Draft LCD released for comment

D: Draft under development; not yet released for comment

E: Formal comment period has ended; comments now being considered F: Final new/revised LCD has been issued for notice

LCD/LMRP Article Comment Summary Additional Information

Cardiac Rehabilitation (DRAFT POLICY)

Search LCDs/LMRPs Effective: 3/1/2008

Status: Draft Final

Revision Date: 11/14/2007

LCD Title

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Contractor Name

TrailBlazer Health Enterprises, LLC Contractor Number z 04001. z 04002. Contractor Type z MAC – Part A. z MAC – Part B.

AMA CPT/ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2007 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

z Medicare Benefit Policy Manual – Pub. 100-02.

z Medicare National Coverage Determinations Manual – Pub. 100-03: Ch. 20.10.

z Medicare Claims Processing Manual – Pub 100-04: Chapter 32, Section 140-140.1. “Cardiac Rehabilitation Programs and Coding Requirements.”

z Change Request 4401, dated April 21, 2006. This CR includes additional clinical indications for coverage of cardiac rehabilitation.

z Correct Coding Initiative – Medicare Contractor Beneficiary and Provider Communications Manual – Pub. 100-09, Chapter 5.

z Social Security Act (Title XVIII) Standard References, Sections: { 1862(a)(1)(A) Medically Reasonable & Necessary.

{ 1862(a)(1)(D) Investigational or Experimental. { 1833(e) Incomplete Claim.

Primary Geographic Jurisdiction z CO – 04101.

z NM – 04201. z OK – 04301. z TX – 04401.

{ Indian Health Service.

{ End Stage Renal Disease (ESRD) Facilities. { Skilled Nursing Facilities (SNFs).

{ Rural Health Clinics (RHCs). z CO – 04102.

z NM – 04202. z OK – 04302. z TX – 04402.

{ Indian Health Service.

Secondary Geographic Jurisdiction N/A

Oversight Region z Region VI.

Original Determination Effective Date 03/01/2008

03/21/2008 06/13/2008

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N/A

Revision Effective Date N/A

Revision Ending Date N/A

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 or valvular 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 postcardiac event phase; Phase II is the outpatient immediate posthospitalization recuperation phase; Phase III is the long-term maintenance phase and is not payable under Medicare. This LCD encompasses Phase II or outpatient posthospital cardiac rehabilitation. Phase II programs are typically initiated one to three weeks after hospital discharge and consist of a series of medically supervised exercise sessions with Continuous Electrocardiograph

Monitoring (CEM). Clinically optimal results are obtained if these sessions are conducted two to three times per week over a 12–18-week period for no more than 36 sessions.

Indications

Cardiac rehabilitation by national LCD is covered for only six groups of patients:

z Patients who begin the program within 12 months of an acute Myocardial Infarction (MI). z Patients who have had Coronary Artery Bypass Graft (CABG) surgery.

z Patients with stable angina pectoris.

z Patients who have had heart valve repair/replacement.

z Patients who have had Percutaneous Transluminal Coronary Angioplasty (PTCA) or coronary stenting. z Patients who have had a heart or heart-lung transplant.

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:

z The facility meets the definition of a hospital outpatient department or a physician-directed clinic, i.e., 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.

z 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.

z The program is conducted in an area set aside for the exclusive use of the program while it is in session. z The program is staffed by personnel necessary to conduct the program safely and effectively and who

are trained in both basic and advanced life support techniques and in exercise therapy for coronary disease. When conducted in a hospital, an identified physician must be immediately available. This does not require that a physician be physically present in the exercise room itself but must be immediately available and accessible at all times in case of an emergency.

z When conducted in the hospital, the non-physician personnel are employees of the hospital conducting the program.

z When conducted in a clinic or physician’s office, the non-physician personnel are employees of the physician or clinic conducting the program and their services are “incident to” a physician’s professional services.

B. Diagnoses

z For MI, the date of entry into the program must be within 12 months of the date of infarction. z 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 six months of the CABG procedure. z For angina, all patients must have a pre-entry stress test that is positive for exercise-induced ischemia

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or 1 mm horizontal or downsloping ST segment depressions. Over the years, nuclear perfusion studies have supplanted standard Electrocardiogram (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.

z For patients with heart valve repair or replacement, the program should be early enough to provide a restorative benefit. Therefore, the date of entry must be within six months of surgery.

z For patients who have had a PTCA or stent replacement, the program should be early enough to provide a restorative benefit. Therefore, the date of entry must be within six months of surgery.

z Patients who have had a heart or heart-lung transplant may present special and complex posttransplant management problems. The date of entry is extended to within one year of the surgery.

C. Frequency and Duration

z The frequency and duration of the program are generally a total of 36 sessions, two to three times per week over 12–18 weeks. Sessions extending beyond the 18 weeks will be denied as not medically necessary unless additional documentation of necessity is demonstrated.

z Services at a frequency of fewer than two sessions per week will be considered not medically necessary unless additional documentation is demonstrated verifying the patient was unable to attend due to illness or hospitalization.

z 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 a total of 36 sessions, two to three sessions per week for 12–18 weeks.

{ Phase IIB consists of an additional series of 36 sessions, two to three times per week for 12–18 weeks and will only be allowed if determined to be medically necessary. The total number of allowable

sessions (Phase IIA and IIB combined) is 72 within a 36-week period. Phase IIB benefits must meet additional medical necessity criteria; specifically, there must be clear demonstration the patient is benefiting from cardiac rehabilitation and that the exit criterion below has not been met.

D. Exit Criterion

Exit criteria include, but are not restricted to, the following clinical parameters:

z The patient has achieved a stable level of exercise tolerance without ischemia or dysrhythmia. z Symptoms of angina or dyspnea are stable at the patient’s maximum exercise level.

z The patient’s resting blood pressure and heart rate are within normal limits.

z The stress test is not positive during exercise. A positive stress test in this context implies an ECG with a junctional depression of 2 mm or more associated with slowly rising, horizontal or down-sloping ST segment.

z For patients with valvuloplasty or valve replacement, benefits are available for Phase IIA only. Data showing that extension of the program beyond the 36 sessions is reasonable and necessary is not available.

z The posttransplant patient poses a special challenge for the cardiac rehabilitation team. Issues such as deconditioning and cachexic deterioration may complicate the definition of a reasonable exit criterion. Based on the study of long-term cardiopulmonary exercise performed after heart transplant by Osade et al, this contractor will use a peak oxygen consumption (VO2) of greater than 90 percent predicted as the exit criterion for Phase IIA. Patients whose VO2 is less than 90 percent predicted may qualify for the additional Phase IIB.

E. Non-Covered Diagnoses

z Use of any ICD-9-CM diagnosis code not in the “ICD-9-CM Diagnosis Codes That Support Medical Necessity” section of this LCD will be cause for denial of claims.

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

z Congestive heart failure in the absence of other covered conditions is not included as a covered condition of cardiac rehabilitation in the CMS National Coverage Determination Manual, Publication 100-03, Section 20.10.

F. Other Services

z Evaluation and Management (E/M) services, ECGs 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.

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z Group I services include:

{ Continuous ECG telemetric monitoring during exercise.

{ ECG rhythm strip with interpretation and physician’s revision of exercise prescription.

{ Limited examination for physician follow-ups to adjust medication or for other treatment changes. A visit including one or more of the Group I services is considered as one routine cardiac rehabilitation visit. 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 services need to be performed at each visit.

z Group II services include:

{ 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.

{ 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 three months (usually the completion of the program).

{ Other physician services, as needed.

For requirements on physical medicine and rehabilitation modalities and procedures, see TrailBlazer’s LCD “Physical Medicine and Rehabilitation, Outpatient - 4Y-22.”

Note: Type of Bill and Revenue Codes DO NOT apply to Part B. Coverage Topics

Cardiac Rehabilitation Program Type of Bill Codes

13X, 85X

Revenue Codes

Note: TrailBlazer has identified the Type of Bill (TOB) and Revenue Center (RC) codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all the CPT/HCPCS codes listed can be billed with all TOB and/or RC codes listed. CPT/HCPCS codes are required to be billed with specific TOB and RC codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Pub. 100-04, Claims Processing Manual, for further guidance.

0943

CPT/HCPCS Codes

ICD-9-CM Codes That Support Medical Necessity

The CPT/HCPCS codes included in this LCD will be subjected to procedure to diagnosis editing. The

following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.

Medicare is establishing the following limited coverage for CPT/HCPCS codes 93797 and 93798: Covered for:

Note: Providers are reminded to refer to the long descriptors of the CPT codes in their CPT books. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web.

93797© Cardiac rehab

93798© Cardiac rehab/monitor

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Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.

Diagnoses That Support Medical Necessity N/A

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

Diagnoses That DO NOT Support Medical Necessity

All diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD. Documentation Requirements

Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.

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

Any diagnosis submitted must have documentation in the patient’s record to support coverage and medical necessity.

All cardiac rehabilitation providers must have documentation of the qualifying event in the patient’s medical record. 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.

When billing CPT code 93798, the documentation must clearly indicate the patient is receiving continuous 410.30–410.32 Acute myocardial infarction of inferoposterior wall

410.40–410.42 Acute myocardial infarction of other inferior wall 410.50–410.52 Acute myocardial infarction of other lateral wall 410.60–410.62 True posterior wall infarction

410.70–410.72 Subendocardial infarction

410.80–410.82 Acute myocardial infarction of other specified sites 410.90–410.92 Acute myocardial infarction of unspecified site

412 Old myocardial infarction

Note: ICD-9-CM code 412 (old myocardial infarction) refers to an MI that has occurred more than eight weeks prior to cardiac rehabilitation services.

413.0–413.1 Angina pectoris

413.9 Other and unspecified angina pectoris V42.1 Heart replaced by transplant

V42.2 Heart valve replaced by transplant

V42.89 Organ or tissue replaced by transplant, other Note: Use V42.89 for heart-lung transplant V43.3 Heart valve replaced by other means V45.81 Post-surgical aortocoronary bypass status

V45.82 Percutaneous transluminal coronary angioplasty status

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ECG monitoring.

A cardiac rehabilitation record must be maintained. All components, including ECG strips, must be maintained. All components of the service (medical assessment, ECG monitoring, smoking cessation, dietary counseling and psychological counseling) must be assessed and provided, where appropriate. It is not expected that every component is provided at each session but the total Phase II (A and B) record must reflect those benefits.

A record must be kept indicating the identity of the supervising physician and the identity of the physician who will respond immediately should an adverse consequence develop. This record must be made

available to Medicare upon request. Appendices

N/A

Utilization Guidelines

Refer to “Indications and Limitations of Coverage and/or Medical Necessity,” Section C, “Frequency and Duration” above.

Sources of Information and Basis for Decision

J4 (CO, NM, OK, TX) MAC Integration

TrailBlazer Health Enterprises, LLC adopted the TrailBlazer LCD, “Cardiac Rehabilitation,” for the Jurisdiction 4 (J4) MAC transition.

Full disclosure of sources of information is found with original contractor LCD.

Chan PS, Krumholz HM, Nichol G, et al. Delayed time to defribrillation after in-hospital cardiac arrest. NEJM, 2008 (1):9-17.

Other Contractor Local Coverage Determinations

“Cardiac Rehabilitation,” Trailblazer Health Enterprises, LLC LCD, (00400) L23932, (00900) L23945. “Cardiac Rehabilitation,” BlueCross BlueShield of Arkansas (Pinnacle) LCD, (NM, OK) L13415.

Start Date of Notice Period 12/20/2007

Revision History

Number Date Explanation

N/A 06/13/2008 LCD effective in TX Part A and Part B and Part A CO and NM 06/13/2008 N/A 03/21/2008 LCD effective in CO Part B 03/21/2008

N/A 03/01/2008 LCD effective in NM Part B and OK Part A and Part B 03/01/2008 12/20/2007 Consolidated LCD posted for notice effective: 12/20/2007

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Topics: LocalCoverageDeterminations, PartBColorado Subtopics: Not Subtopic Specific

References

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