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CARDIAC OUTPATIENT REHABILITATION (EXERCISE TRAINING) Protocol: CAR032 Effective Date: November 10, 2014 Table of Contents Page COMMERCIAL COVERAGE RATIONALE......................................................................................... 1 MEDICARE & MEDICAID COVERAGE RATIONALE ...................................................................... 2 BACKGROUND ...................................................................................................................................... 5 CLINICAL EVIDENCE ........................................................................................................................... 6 APPLICABLE CODES ............................................................................................................................ 7 REFERENCES ......................................................................................................................................... 7 PROTOCOL HISTORY/REVISION INFORMATION ........................................................................ 10 INSTRUCTIONS FOR USE This protocol provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the enrollee specific document must be referenced. The terms of an enrollee's document (e.g., Certificate of Coverage (COC) or Evidence of Coverage (EOC)) may differ greatly. In the event of a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this Protocol. Other Protocols, Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Protocols, Policies and Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute medical advice. UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice COMMERCIAL COVERAGE RATIONALE Cardiac rehabilitation services are a covered health service when cardiac rehabilitation is ordered by a physician and should meet the following: The program is staffed by licensed therapy providers necessary to conduct the program safely and effectively. Services are provided in a physician’s office or on an outpatient basis at a hospital or alternate facility (such as healthcare facility that provides rehabilitative services). Additional Information: Physician should be available to render emergency services Cardiac Outpatient Rehabilitation (Exercise Training) Page 1 of 10 Facility where the cardiac rehabilitation is performed should have the necessary emergency equipment to conduct the program safely. Education of enrollee on diet, exercise, smoking cessation and sexual activity is considered part of the cardiac rehabilitation program but not separately reimbursable. Cardiac rehabilitation visits may be limited. Please refer to enrollee’s plan specific documents. Limitations and Exclusions: Coverage ends once the enrollee/patient has met the treatment goals for cardiac rehabilitation Patient is unwilling or unable to participate in the therapy or progress towards the treatment plan goals Inpatient cardiac rehabilitation services Programs that do not require the supervision of physician and/or a licensed therapy provider (e.g. home exercise program or unmonitored gym/fitness center/health club program) Maintenance program Gym/fitness center, health club fees, exercise equipment or supplies Biofeedback services may be excluded. Please check enrollee’s plan documents General education and training (video or computerized interactive program) Coverage beyond the maximum cardiac rehabilitation benefit (days or dollars) MEDICARE & MEDICAID COVERAGE RATIONALE There is a Medicare National Coverage Determination for Cardiac Rehabilitation Programs for Chronic Heart Failure (NCD 20.10.1), accessed September 2014. There is no Local Coverage Determination for Nevada for Cardiac Rehabilitation Programs. The National Coverage Determination is as follows: NCD 20.10.1 Cardiac Rehabilitation Programs for Chronic Heart Failure Description Information Cardiac Rehabilitation Programs Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service. Item/Service Description A. General As per sections 1861(s)(2)(CC) and 1861(eee)(1) of the Social Security Act, items and services furnished under a Cardiac Rehabilitation (CR) program may be covered under Medicare Part B. Among other things, Medicare regulations at 42CFR410.49 define key terms, address the components of a CR program, establish the standards for physician supervision, and limit the maximum number of program sessions that may be furnished. The regulations also describe the cardiac conditions that would enable a beneficiary to obtain CR services. Effective for dates of service on and after January 1, 2010, coverage is permitted for beneficiaries who have experienced one or more of the following: • Acute myocardial infarction within the preceding 12 months • Coronary artery bypasses surgery Cardiac Outpatient Rehabilitation (Exercise Training) Page 2 of 10 • Current stable angina pectoris • Heart valve repair or replacement • Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting • A heart or heart-lung transplant The Centers for Medicare & Medicaid Services (CMS) may add “other cardiac conditions as specified through a national coverage determination” (See 42 CFR §410.49(b)(1)(vii). Indications and Limitations of Coverage B. Nationally Covered Indications Effective for dates of service on and after February 18, 2014, CMS has determined that the evidence is sufficient to expand coverage for cardiac rehabilitation services under 42 CFR §410.49(b)(1)(vii) to beneficiaries with stable, chronic heart failure, defined as patients with left ventricular ejection fraction of 35% or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least six weeks. Stable patients are defined as patients who have not had recent (< 6 weeks) or planned (< 6 months) major cardiovascular hospitalizations or procedures. (See section A above for other indications covered under 42 CFR §410.49(b)(1)(vii). C. Nationally Non-Covered Indications Any cardiac indication not specifically identified in 42 CFR §410.49(b)(1)(vii) or identified as covered in this NCD or any other NCD in relation to cardiac rehabilitation services is considered non-covered. D. Other NA 140.2 – Cardiac Rehabilitation Program Services Furnished On or After January 1, 2010 Medicare covers cardiac rehabilitation items and services for patients who have experienced one or more of the following: • • • • • • An acute myocardial infarction within the preceding 12 months; or A coronary artery bypass surgery; or Current stable angina pectoris; or Heart valve repair or replacement; or Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; or A heart or heart-lung transplant. Cardiac rehabilitation programs must include the following components: • Physician-prescribed exercise each day cardiac rehabilitation items and services are furnished; • Cardiac risk factor modification, including education, counseling, and behavioral intervention at least once during the program, tailored to patients‘ individual needs; • Psychosocial assessment; • Outcomes assessment; and • An individualized treatment plan detailing how components are utilized for each patient. Cardiac Outpatient Rehabilitation (Exercise Training) Page 3 of 10 Cardiac rehabilitation items and services must be furnished in a physician‘s office or a hospital outpatient setting. All settings must have a physician immediately available and accessible for medical consultations and emergencies at all time items and services are being furnished under the program. This provision is satisfied if the physician meets the requirements for the direct supervision of physician‘s office services as specified at 42 CFR 410.26 and for hospital outpatient therapeutic services as specified at 42 CFR 410.27. As specified at 42 CFR 410.49(f)(1), cardiac rehabilitation program sessions are limited to a maximum of 2 1-hour sessions per day for up to 36 sessions over up to 36 weeks, with the option for an additional 36 sessions over an extended period of time if approved by the Medicare contractor. 140.3 – Intensive Cardiac Rehabilitation Program Services Furnished On or After January 1, 2010 Medicare covers intensive cardiac rehabilitation items and services for patients who have experienced one or more of the following: An acute myocardial infarction within the preceding 12 months; or A coronary artery bypass surgery; or Current stable angina pectoris; or Heart valve repair or replacement; or Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; or A heart or heart-lung transplant. Intensive cardiac rehabilitation programs must include the following components: Physician-prescribed exercise each day cardiac rehabilitation items and services are furnished; Cardiac risk factor modification, including education, counseling, and behavioral intervention at least once during the program, tailored to patients‘ individual needs; Psychosocial assessment; Outcomes assessment; and An individualized treatment plan detailing how components are utilized for each patient. Intensive cardiac rehabilitation programs must be approved. In order to be approved, a program must demonstrate through peer-reviewed published research that it has accomplished one or more of the following for its patients: Positively affected the progression of coronary heart disease; Reduced the need for coronary bypass surgery; and Reduced the need for percutaneous coronary interventions. An intensive cardiac rehabilitation program must also demonstrate through peer-reviewed published research that it accomplished a statistically significant reduction in 5 or more of the following measures for patients from their levels before cardiac rehabilitation services to after cardiac rehabilitation services: Low density lipoprotein; Cardiac Outpatient Rehabilitation (Exercise Training) Page 4 of 10 Triglycerides; Body mass index; Systolic blood pressure; Diastolic blood pressure; and The need for cholesterol, blood pressure, and diabetes medications. Intensive cardiac rehabilitation items and services must be furnished in a physician’s office or a hospital outpatient setting. All settings must have a physician immediately available and accessible for medical consultations and emergencies at all time items and services are being furnished under the program. This provision is satisfied if the physician meets the requirements for direct supervision of physician office services as specified at 42 CFR 410.26 and for hospital outpatient therapeutic services as specified at 42 CFR 410.27. Intensive cardiac rehabilitation program sessions are limited to 72 1-hour sessions, up to 6 sessions per day, over a period of up to 18 weeks. For Medicare and Medicaid Determinations Related to States Outside of Nevada: Please review Local Coverage Determinations that apply to other states outside of Nevada. http://www.cms.hhs.gov/mcd/search BACKGROUND Cardiac Outpatient Rehabilitation (AKA Phase II cardiac rehabilitation), is a comprehensive, longterm program including medical evaluation, prescribed exercise, cardiac risk factor modification, education, and counseling. Phase II refers to outpatient, medically supervised programs that are typically initiated 1 to 3 weeks after hospital discharge and provide appropriate electrocardiographic monitoring. Underlying conditions may include recent myocardial infarction, heart transplant, valve surgery, or revascularization. It may also be helpful for patients with heart failure with or without left ventricular assist devices or for patients with angina. Cardiac rehabilitation combines exercise training with counseling about improving modifiable coronary risk factors. Electrocardiographic (ECG) monitoring during therapy may or may not be required. Cardiac rehabilitation provided in the outpatient setting is one potential component of the continuum of care, at times preceded by inpatient rehabilitation or followed by self-management and ongoing exercise. Rehabilitation programs for cardiac transplant patients must take into account the denervated state. Patients with significant valvular dysfunction are at greater risk for ventricular fibrillation and tachyarrhythmias as well as exertional syncope. Contraindications for entry into a comprehensive program include unstable cardiac conditions (e.g., uncontrolled arrhythmias, critical aortic stenosis, unstable angina, pericarditis), active infection (e.g., endocarditis, fever), recent venous thromboembolism, uncontrolled hypertension, or a severe orthopedic condition that would prohibit exercise. Baseline assessment prior to admission into a cardiac rehabilitation program includes history and physical examination, review of medications, lipid testing, resting 12 lead ECG, and exercise stress testing. Exercise prescription is based on the results of the monitored exercise test; goals may be based Cardiac Outpatient Rehabilitation (Exercise Training) Page 5 of 10 on heart rate, rating of perceived exertion (RPE), or metabolic equivalent units (METs). The exercise component typically includes both aerobic activities and strength training. CLINICAL EVIDENCE Meta-analysis of clinical trials of cardiac rehabilitation and other studies for patients with cardiac compromise have demonstrated statistically significant reduction in cardiovascular death, improved health-related quality of life, improved exercise capacity, improved functional capacity, but no reduction in recurrent myocardial infarction or revascularization. A retrospective analysis of 1579 subjects who had undergone cardiac bypass concluded that exercise training in supervised cardiac rehabilitation programs significantly improved exercise capacity, measures of chronotropic dynamics, and prognostic risk scores, which translate into a decrease in predicted mortality. Patients with coronary artery disease who did not receive exercise therapy after hospitalization were found to decline in physical activity level. Exercise training is recommended for patients with chronic atrial fibrillation or heart failure who are stable; it results in decreased mortality and hospitalizations, and in improved quality of life. In a retrospective chart review of 235 consecutive obese patients with coronary heart disease, cardiac rehabilitation reduced overall risk and improved health-related quality of life. It is proposed that, with the use of a ventricular assist device as a bridge to transplant, there is an opportunity to improve patient fitness level prior to transplant. The exercise component of cardiac rehabilitation typically includes both aerobic activities and strength training. Studies compared aerobic exercise alone versus aerobic exercise and strength training and found that the addition of the strength training resulted in greater improvements at follow-up. A metaanalysis found that aerobic training alone reversed remodeling for stable left ventricular heart failure patients; authors were unable to confirm this effect for the combination of aerobic training and strengthening. A group-based aerobic interval training program improved functional capacity and the quality of life in patients with heart failure. A randomized controlled trial that included 67 hypercholesterolemic men concluded that 12 weeks of moderate intensity walking was sufficient to improve the ratio of total cholesterol to HDL cholesterol. Long-term aerobic exercise training is effective in improving respiratory efficiency, increasing left ventricular systolic function, attenuating negative remodeling, and stopping further progression in patients with coronary heart disease and chronic heart failure after successful percutaneous coronary intervention. Studies have shown benefits with protocols that vary in duration, intensity, and modalities across a variety of cardiac disorders. One study that addressed long-term outcomes after cardiac rehabilitation showed additional benefit to ongoing patient monitoring and counseling over a 4-year period for those with ischemic heart disease. ECG monitoring was not consistent across studies and was not a variable that was considered related to outcomes, but it may be appropriate as one component of supervision. It is used initially for all patients and subsequently as an adjunct for more significantly impaired patients based on the results of monitored exercise testing and clinical symptoms. Other components of supervision may include intermittent or continuous monitoring of heart rate, blood pressure, and RPE. American Association of Cardiovascular and Pulmonary Rehabilitation guidelines classify patients into high-risk, moderate-risk, and low-risk for exercise participation, and recommend graded supervision and monitoring based on risk. Cardiac Outpatient Rehabilitation (Exercise Training) Page 6 of 10 Education components may include information about medication management, lipid management, diet, exercise, smoking cessation, and the disease process. One study compared video education in addition to typical education for self-care and symptom management with typical care alone and found improved self-care with the addition of the video education. Another study noted improvement in adherence with telephone support as compared with no support. One program compared exercise and support with a comprehensive program and found no difference. One study compared a home-based program to no program and determined a decrease in hospitalizations with a home-based program. A study showed that attitudes, self-efficacy, and cognition play a critical role in self management for heart failure subjects. Self-management, adherence, and long-term adherence to any behavioral change remain a challenge for many, and there is little research to support one method of support, follow-up, and reinforcement over others. Inappropriate Indications Contraindications for entry into a comprehensive program include unstable cardiac conditions (e.g., uncontrolled arrhythmias, critical aortic stenosis, unstable angina, pericarditis), active infection (e.g., endocarditis, fever), recent venous thromboembolism, uncontrolled hypertension, a severe orthopedic condition that would prohibit exercise, uncompensated heart failure, or for those post heart transplant, an acute rejection episode. APPLICABLE CODES The codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the benefit document. This list of codes may not be all inclusive. CPT® Code 93797 93798 Description Physician or other qualified health care professional services for outpatient cardiac rehabilitation without continuous ECG monitoring (per session) Physician or other qualified health care professional services for outpatient cardiac rehabilitation with continuous ECG monitoring (per session) CPT® is a registered trademark of the American Medical Association. HCPCS Code G0422 G0423 S9472 Description Intensive cardiac rehabilitation; with or without continuous ECG monitoring with exercise, per session. Intensive cardiac rehabilitation; with or without continuous ECG monitoring without exercise, per session Cardiac rehabilitation program, non-physician, per diem REFERENCES Adams BJ, Carr JG, Ozonoff A, Lauer MS, Balady GJ. Effect of exercise training in supervised cardiac rehabilitation programs on prognostic variables from the exercise tolerance test. American Journal of Cardiology 2008;101(10):1403-7. DOI: 10.1016/j.amjcard.2008.01.016. Cardiac Outpatient Rehabilitation (Exercise Training) Page 7 of 10 Albert NM, Buchsbaum R, Li J. Randomized study of the effect of video education on heart failure healthcare utilization, symptoms, and self-care behaviors. Patient Education and Counseling 2007;69(1-3):129-39. DOI: 10.1016/j.pec.2007.08.007. Arnold JM, et al. Canadian Cardiovascular Society consensus conference recommendations on heart failure 2006: diagnosis and management. Canadian Journal of Cardiology 2006;22(1):23-45. Arthur HM, et al. Effect of aerobic vs combined aerobic-strength training on 1-year, post-cardiac rehabilitation outcomes in women after a cardiac event. Journal of Rehabilitation Medicine 2007;39(9):730-5. DOI: 10.2340/16501977-0122. Barbour KA, Miller NH. Adherence to exercise training in heart failure: a review. Heart Failure Reviews 2008;13(1):81-9. DOI: 10.1007/s10741-007-9054-x. Beckers PJ, Denollet J, Possemiers NM, Wuyts FL, Vrints CJ, Conraads VM. Combined enduranceresistance training vs. endurance training in patients with chronic heart failure: a prospective randomized study. European Heart Journal 2008;29(15):1858-66. DOI: 10.1093/eurheartj/ehn222. Brugemann J, Poels BJ, Oosterwijk MH, van der Schans CP, Postema K, van Veldhuisen DJ. A randomised controlled trial of cardiac rehabilitation after revascularisation. International Journal of Cardiology 2007;119(1):59-64. DOI: 10.1016/j.ijcard.2006.07.047. Coghill N, Cooper AR. The effect of a home-based walking program on risk factors for coronary heart disease in hypercholesterolaemic men. A randomized controlled trial. Preventive Medicine 2008;46(6):545-51. DOI: 10.1016/j.ypmed.2008.01.002. Dracup K, et al. Effects of a home-based exercise program on clinical outcomes in heart failure. American Heart Journal 2007;154(5):877-83. DOI: 10.1016/j.ahj.2007.07.019. Dickson VV, Deatrick JA, Riegel B. A typology of heart failure self-care management in non-elders. European Journal of Cardiovascular Nursing 2008;7(3):171-81. DOI: 10.1016/j.ejcnurse.2007.11.005. Franklin BA, de Jong, AT. Exercise prescription. In: AACVPR Cardiac Rehabilitation Resource Manual. Champaign, IL: Human Kinetics; 2006:75-87 Haykowsky MJ, Liang Y, Pechter D, Jones LW, McAlister FA, Clark AM. A meta-analysis of the effect of exercise training on left ventricular remodeling in heart failure patients: the benefit depends on the type of training performed. Journal of the American College of Cardiology 2007;49(24):232936. DOI: 10.1016/j.jacc.2007.02.055. Hegbom F, Stavem K, Sire S, Heldal M, Orning OM, Gjesdal K. Effects of short-term exercise training on symptoms and quality of life in patients with chronic atrial fibrillation. International Journal of Cardiology 2007;116(1):86-92. DOI: 10.1016/j.ijcard.2006.03.034. Cardiac Outpatient Rehabilitation (Exercise Training) Page 8 of 10 Kline KS, Scott LD, Britton AS. The Use of Supportive-Educative and Mutual Goal-Setting Strategies to Improve Self-Management for Patients With Heart Failure. Home Healthcare Nurse 2007;25(8):502-510. DOI: 10.1097/01.NHH.0000289104.60043.7d. Kavanagh T. Chronic heart failure. In: AACVPR Cardiac Rehabilitation Resource Manual. Champaign, IL: Human Kinetics; 2006:141-8. Kavanagh T. Cardiac transplantation. In: AACVPR Cardiac Rehabilitation Resource Manual. Champaign, IL: Human Kinetics; 2006:149-54. Lavie CJ, Morshedi-Meibodi A, Milani RV. Impact of cardiac rehabilitation on coronary risk factors, inflammation, and the metabolic syndrome in obese coronary patients. Journal of the Cardiometabolic Syndrome 2008;3(3):136-40. DOI: 10.1111/j.1559-4572.2008.00002.x. Lear SA, et al. The Extensive Lifestyle Management Intervention (ELMI) after cardiac rehabilitation: a 4-year randomized controlled trial. American Heart Journal 2006;152(2):333-9. DOI: 10.1016/j.ahj.2005.12.023. McKelvie RS. Exercise training in patients with heart failure: clinical outcomes, safety, and indications. Heart Failure Reviews 2008;13(1):3-11. DOI: 10.1007/s10741-007-9052-z. Myers J, et al. Effects of exercise training on heart rate recovery in patients with chronic heart failure. American Heart Journal 2007;153(6):1056-63. DOI: 10.1016/j.ahj.2007.02.038. Myers J. Principles of exercise prescription for patients with chronic heart failure. Heart Failure Reviews 2008;13(1):61-8. DOI: 10.1007/s10741-007-9051-0. Nilsson BB, Westheim A, Risberg MA. Long-term effects of a group-based high-intensity aerobic interval-training program in patients with chronic heart failure. American Journal of Cardiology 2008;102(9):1220-4. DOI: 10.1016/j.amjcard.2008.06.046. Puetz TW, Beasman KM, O'Connor PJ. The effect of cardiac rehabilitation exercise programs on feelings of energy and fatigue: a meta-analysis of research from 1945 to 2005. European Journal of Cardiovascular Prevention and Rehabilitation 2006;13(6):886-93. DOI: 10.1097/01.hjr.0000230102.55653.0b. Reid RD, et al. Determinants of physical activity after hospitalization for coronary artery disease: the Tracking Exercise After Cardiac Hospitalization (TEACH) Study. European Journal of Cardiovascular Prevention and Rehabilitation 2006;13(4):529-37. DOI: 10.1097/01.hjr.0000201513.13343.97 Shearer NB, Cisar N, Greenberg EA. A telephone-delivered empowerment intervention with patients diagnosed with heart failure. Heart and Lung 2007;36(3):159-69. DOI: 10.1016/j.hrtlng.2006.08.006. Squires RW, Hamm LF. Exercise and the coronary heart disease connection. In: AACVPR Cardiac Rehabilitation Resource Manual. Champaign, IL: Human Kinetics; 2006:53-62 Cardiac Outpatient Rehabilitation (Exercise Training) Page 9 of 10 Tabet JY, et al. Determination of exercise training level in coronary artery disease patients on beta blockers. European Journal of Cardiovascular Prevention and Rehabilitation 2008;15(1):67-72. DOI: 10.1097/HJR.0b013e3282eff61f. Vasiliauskas D, et al. Exercise training after coronary angioplasty improves cardiorespiratory function. Scandinavian Cardiovascular Journal 2007;41(3):142-8. DOI: 10.1080/14017430601187116. Wise FM. Exercise based cardiac rehabilitation in chronic heart failure. Australian Family Physician 2007;36(12):1019-24. PROTOCOL HISTORY/REVISION INFORMATION Date 09/25/2014 03/28/2013 03/22/2012 03/24/2011 12/23/2010 Action/Description Corporate Medical Affairs Committee The foregoing Health Plan of Nevada/Sierra Health & Life Health Operations protocol has been adopted from an existing UnitedHealthcare coverage determination guideline that was researched, developed and approved by the UnitedHealthcare Coverage Determination Committee. Cardiac Outpatient Rehabilitation (Exercise Training) Page 10 of 10