Clinical Policy Title: Pulmonary Rehabilitation

P a g e 11 Clinical Policy Title: Pulmonary Rehabilitation Clinical Policy Number: 07.02.01 Effective Date: Sept. 1, 2013 Initial Review Date: March 21, 2013 Most Recent Review Date: March 19, 2014 Next Review Date: March, 2015 Policy contains: Chronic pulmonary disease Lung transplantation Lung volume reduction surgery ABOUT THIS POLICY: TrueBlue has developed clinical policies to assist with making coverage determinations. TrueBlue clinical policies are based on guidelines from established industry sources such as Centers for Medicare and Medicaid (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer reviewed professional literature. These clinical policies, along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state or plan specific definition of medically necessary, and the specific facts of the particular situation are considered by TrueBlue when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. TrueBlue clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. TrueBlue clinical policies are reflective of evidence based medicine at the time of review. As medical science evolves, TrueBlue will update its clinical policies as necessary. TrueBlue clinical policies are not guarantees of payment. Coverage Policy: TrueBlue considers the use of pulmonary rehabilitation to be clinically proven and therefore, medically necessary when all of the following criteria are met: Any of the Appropriate Diagnoses listed below: Asthma. Chronic Obstructive Pulmonary Disease (COPD) stages II-IV. Bronchiectasis. Cystic fibrosis. Interstitial lung disease (e.g. idiopathic pulmonary fibrosis (IPC)). 1

Obliterative bronchiolitis. Restrictive respiratory disease due to a neuromuscular disorder (e.g. amyotrophic lateral sclerosis (ALS), or Guillain Barré). Sarcoidosis. Pre- and post- lung transplantation. Pre- and post- lung volume reduction surgery. Other documented severe pulmonary condition. Appropriate Candidate Individual meets all of the following eligibility requirements: Dyspnea with rest or exertion. Limited physical activity and is unable to perform activities of daily living. Have no contraindications for participation in a supervised exercise program. Is capable of participating in the treatment plan (physically and cognitively). Limitations: Pulmonary rehabilitation should not be used in individuals unable to safely participate in an exercise program. Pulmonary rehabilitation services are generally provided in an outpatient setting. An individual may receive up to a life-time maximum of 72 pulmonary rehabilitation sessions. NOTE: The following codes are not listed on the AHCA fee schedule: S9473 - Pulmonary rehabilitation program, non-physician provider, per diem. G0302 - Preoperative pulmonary surgery services for preparation for LVRS, complete course of services, to include a minimum of 16 days of services. G0303 - Preoperative pulmonary surgery services for preparation for LVRS, 10 to 15 days of services. G0304 - Preoperative pulmonary surgery services for preparation for LVRS, 1 to 9 days of services. G0305 - Postdischarge pulmonary surgery services after LVRS, minimum of 6 days of services. G0424 - Postdischarge pulmonary surgery services after LVRS, minimum of 6 days of services. Revenue Code - 0948 - Other Therapeutic Services - Pulmonary Rehabilitation. Alternative Covered Services: Physician services in the treatment of chronic pulmonary disease and medications as prescribed. 2

Background: Pulmonary disease is a major cause of morbidity and mortality in the United States. As an example, chronic obstructive pulmonary disease (COPD) is the 4th leading cause of chronic disease-related mortality in the United States; mortality has increased over the last 20 years. Treatment of pulmonary diseases involves trying to arrest the underlying pathophysiology, such as removing the offending agent (e.g. smoking cessation is the only intervention shown to slow disease progression in COPD), and preventing and treating complications related to the lung disease (e.g. suppression of bacterial infection), but there are other interventions that can positively impact disability associated with pulmonary disease. The most compelling of these is pulmonary rehabilitation. The American Thoracic Society/European Respiratory Society (ATS/ERS) defines pulmonary rehabilitation as: a comprehensive intervention based on a thorough patient assessment followed by patient tailored therapies that include, but are not limited to, exercise training, education, and behavior change, designed to improve the physical and psychological condition of people with chronic respiratory disease and to promote the long-term adherence to health-enhancing behaviors. (Spruit 2013) This definition was updated from 2006 to emphasize the importance of changing behavior as well as stabilizing or reversing systemic manifestations of the disease. The goals of pulmonary rehabilitation are to reduce levels of morbidity and to improve activity and participation. Such programs are often begun while an individual is an inpatient in a healthcare facility, and may be continued in an outpatient setting. Pulmonary rehabilitation programs may also benefit individuals, who are facing lung transplantation or lung reduction surgery, by improving activity tolerance, stabilizing disease progression and assisting in therapeutic techniques employed post-operatively. Inclusion/exclusion criteria According to the ATS/ERS, pulmonary rehabilitation should be considered for any patient with chronic respiratory disease who have persistent symptoms, limited activity, and/or are unable to adjust to illness despite otherwise optimal medical management. (Spruit 2013) Evidence on the selection of patients who might benefit is derived mostly from patients with COPD, with a growing number of studies describing rehabilitation in other chronic lung diseases such as asthma, bronchiectasis, cystic fibrosis that may benefit from an in-depth pulmonary rehabilitation program. Gains can be achieved from pulmonary rehabilitation regardless of age, sex, lung function, or smoking status. Pulmonary rehabilitation is generally considered a necessary component before and after lung volume reduction surgery and lung transplantation. (Spruit 2013) The optimal candidates are clinically stable and motivated to achieve the fullest benefit from pulmonary rehabilitation. Data are limited on predictors of nonadherence, but predictors of reduced long-term adherence include social isolation and continued smoking. Patients who are hypoxemic at rest or with exercise should not be excluded from rehabilitation but should be provided with ambulatory oxygen during the exercise sessions. (ATS/ERS 2006) 3

Exclusion criteria include significant orthopedic or neurologic problems that reduce mobility or cooperation with physical training. In addition, poorly controlled coexisting medical conditions, especially psychiatric or unstable cardiac disease, may limit participation, thereby making the patient an unsuitable candidate. (ATS/ERS 2006) There is no consensus on the optimal number of sessions per week or the optimal duration of pulmonary rehabilitation. (Spruit 2013) Outpatient programs commonly meet 2 or 3 days/week, while inpatient programs are usually planned for 5 days/week. The session length per day is generally 1 4 hours. The evidence suggests longer programs are thought to produce greater gains and maintenance of benefits, with a minimum of 8 weeks recommended to achieve a substantial effect. While programs longer than 12 weeks have been shown to produce greater sustainable benefits than shorter programs, improvement in functional exercise capacity seems to plateau within 12 weeks of the start of the pulmonary rehabilitation program, despite continued training. (Spruit 2013) METHODS Searches: We searched PubMed and the databases of: UK NHS Centre for Reviews and Dissemination; AHRQ guideline clearinghouse and evidence-based practice centers; Centers for Medicare and Medicaid Services. Searches were conducted on February 13, 2014 using the terms pulmonary rehabilitation, rehabilitation and lung diseases. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use pre-determined transparent methods to minimize bias: effectively treating the review as a scientific endeavor, thus are rated highest in evidence grading hierarchies. Guidelines based on systematic reviews; and Economic analyses: cost-effectiveness, -benefit or -utility studies, which report both costs and outcomes; (but not simple cost studies), sometimes referred to as efficiency studies, also rank near the top of evidence hierarchies. Findings: The evidence for this policy is based on an evidence-based review and guidelines developed by the American College of Chest Physicians and the American Association of Cardiovascular and Pulmonary Rehabilitation. (ACCP/AACVPR 2007) This report identified several economic studies. Three other systematic reviews were identified, which would not materially change the findings below. (Liu 2014; Beauchamp 2013; Cavalheri 2013) The success of pulmonary rehabilitation stems from its favorable influence on systemic effects and comorbidities associated with chronic lung disease. The preponderance of evidence has shown beneficial outcomes of pulmonary rehabilitation in patients primarily with COPD enrolled in hospital-based outpatient programs. 4

There is high quality evidence that 6 to 12 weeks of pulmonary rehabilitation produces benefits in several outcomes that decline gradually over 12 to 18 months, with the exception of some benefits, such as health-related quality of life, that were sustained above controls at 12 to 18 months. Other benefits include: o Symptom improvement in dyspnea (High quality). o Lower health care utilization (Moderate quality). o Psychosocial benefits (Moderate quality). There is low, very low or insufficient evidence of effectiveness of maintenance strategies on long-term outcomes or survival or of the cost-effectiveness of pulmonary rehabilitation. There is high quality evidence of effectiveness for including unsupported endurance training of the upper extremities, strength training and exercise training of the lower extremity muscles in pulmonary rehabilitation programs. There is moderate quality evidence of effectiveness for including education strategies (collaborative self-management and prevention and treatment of exacerbations) and noninvasive ventilation as an adjunct to exercise training in selected patients with severe COPD. Moderate quality evidence argues against routine use of inspiratory muscle training. There is moderate quality evidence of effectiveness of pulmonary rehabilitation for some patients with chronic respiratory diseases other than COPD. There is low, very low quality or insufficient evidence of effectiveness for including psychosocial interventions as a single therapeutic modality, supplemental oxygen during exercise training in patients with severe exercise-induced hypoxemia and nutritional supplementation in pulmonary rehabilitation programs. Supplemental oxygen may benefit patients without exercise-induced hypoxemia to improve exercise endurance during high-intensity exercise programs. For patients with chronic respiratory diseases other than COPD, modifications should include treatment strategies specific to individual diseases and patients in addition to treatment strategies common to both COPD and non-copd patients. Areas in need of further research include: Optimizing the effectiveness of pulmonary rehabilitation, including defining the optimal intensity and duration of exercise training and defining the effects of the nonexercise components and the role of adjunctive therapies such as hormonal therapy, supplemental oxygen administration to nonhypoxemic patients and noninvasive ventilation. Identifying the predictors and rationale of nonadherence and nonparticipation to develop effective strategies to engage participation and maintain the benefits of pulmonary rehabilitation over the long term. Expanding access to large populations of patients with chronic pulmonary diseases presently without access to pulmonary rehabilitation programs. 5

Summary of Clinical Evidence Citation Beauchamp 2013 Cavalheri 2013 Cochrane review Liu 2014 Content, Methods, Recommendations Key Point Systematic review of 7 RCTs (n=619) with moderate to severe COPD. At 6-month follow-up there was a significant difference in exercise capacity in favor of the post-rehabilitation interventions (SMD, -0.20; 95% CI, -0.39 to -0.01), not sustained at 12 months (SMD, -0.09; 95% CI, -0.29 to 0.11). No effect on HRQOL. Key Points Systematic review of 3 RCTs (n=178) post lung resection for NSCLC with or without chemotherapy. Quality of evidence: low with high risk of bias. Exercise training was effective in increasing exercise capacity vs. control group (mean difference (MD) 50.4 m; 95% confidence interval (CI) 15.4 to 85.2 m).. No between-group differences were observed in HRQOL standardized mean difference (SMD) 0.17; 95% CI -0.16 to 0.49) or FEV1 (MD-0.13 L; 95% CI -0.36 to 0.11 L). No differences in quadriceps force. Larger RCTs needed. Key Points Meta-analysis of 18 RCTs (n=733) of patients with COPD underwent 12 weeks of homebased pulmonary rehab v. no intervention. Quality assessment: low to unclear risk of bias. Statistically significant improvement in dyspnea status, HRQoL scores, exercises capacity, and pulmonary functions (measured by forced expiratory volume in onesecond/forced vital capacity (FEV1 /FVC). No statistically significant changes in maximal workload, hospital admission, cost of care, or mortality between the two groups. Authors conclusions: Home-based pulmonary rehabilitation programs represent effective therapeutic intervention approaches for relieving COPD-associated respiratory symptoms and improving HRQoL and exercise capacity. Rigorously designed, large-scale RCTs are still needed to identify an optimal standard home-based pulmonary rehabilitation program. Glossary: Chronic Obstructive Pulmonary Disease (COPD) a progressive lung disease caused by long term exposure to substances that irritate and damage the lungs (e.g. smoking). Symptoms include chronic cough, dyspnea, wheezing and chest tightness and worsen over time. The National Institutes of Health includes chronic emphysema and chronic bronchitis under the definition of COPD. COPD stages (per GOLD): I. FEV 1 / FVC < 0.7, and FEV 1 80% predicted mild. II. FEV 1 / FVC < 0.7, and FEV 1 50%-80% predicted moderate. III. FEV 1 / FVC < 0.7, and FEV 1 30%-50% predicted severe. 6

IV. FEV 1 / FVC < 0.7, and FEV 1 < 30% predicted very severe. Dyspnea Shortness of breath or difficulty breathing. Forced Expiratory Volume (FEV1) the amount of air that can be exhaled in the first second after taking the deepest breath as possible. An important measurement in lung function, it can be used to measure the presence of lung disease or disease progression: the lower the value, the worse the disease. Forced Vital Capacity (FVC) - the maximum amount of air a person can forcibly exhale from the lungs after a maximum inhalation. The rate of exhalation can help determine the presence of COPD. Lung Volume Reduction Surgery Surgical procedure for someone who has emphysema to remove the non functional diseased portion of the lung in an attempt to restore more normal and efficient breathing. Pulmonary Rehabilitation refers to integrated behavioral, educational, occupational, respiratory, and physical therapy services designed to assist the patient in improved breathing, exercise tolerance and quality of life. Restrictive Pulmonary Disease Disorder characterized by reduced lung volume, either because of an alteration in the lung itself or because of a condition that affects the mechanics of breathing (chest wall, muscles, etc). Related Policies: TrueBlue Utilization Management Program Description. REFERENCES Professional Society Guidelines American Thoracic Society (ATS). Standards for the Diagnosis and Management of Patients with COPD (2004). Available at: http://www.thoracic.org/clinical/copd-guidelines/resources/copddoc.pdf. Accessed February 14, 2014. American Thoracic Society (ATS)/European Respiratory Society (ERS). ATS/ERS statement on pulmonary rehabilitation. [ATS Web site]. May 2006. Available at: http://www.thoracic.org/statements/resources/respiratory-disease-adults/atserspr0606.pdf. Accessed February 14, 2014. Global Initiative for Chronic Obstructive Lung Disease (GOLD). From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014. Available at: http://www.goldcopd.org/. Accessed February 14, 2014. Global Initiative for Chronic Obstructive Lung Disease. Available at: http://www.goldcopd.org/aboutus.html. Accessed February 14, 2014. 7

Institute for Clinical Systems Improvement. Health Care Guideline: Diagnosis and Management of Chronic Obstructive Pulmonary Disease (COPD). Eighth Edition, March 2011. Updated March 2013. https://www.icsi.org/guidelines more/catalog_guidelines_and_more/catalog_guidelines/catalog_respirat ory_guidelines/copd/. Accessed February 14, 2014. Ries, A., Bauldoff, G., Carlin, B., et al. Pulmonary Rehabilitation*Joint ACCP/AACVPR Evidence-Based Clinical Practice Guidelines. CHEST. May 2007; 131 [American College of Chest Physician s Website].Available at: http://journal.publications.chestnet.org/pdfaccess.ashx?resourceid=3666791&pdfsource=13. Accessed February 14, 2014. Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, et al. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15; 188(8):e13-64. Peer-Reviewed References Barnes, P. Medical Progress: Chronic Obstructive Pulmonary Disease. NEJM. 2000; 343:269-80. Beauchamp MK, Evans R, Janaudis-Ferreira T, Goldstein RS, Brooks D. Systematic review of supervised exercise programs after pulmonary rehabilitation in individuals with COPD. Chest. 2013 Oct; 144(4):1124-33. Cavalheri V, Tahirah F, Nonoyama M, Jenkins S, Hill K. Exercise training undertaken by people within 12 months of lung resection for non-small cell lung cancer. Cochrane Database Syst Rev. 2013; 7:Cd009955. Celli, B. JAMA. Clinical Crossroads: A 62-Year-Old Woman with Chronic Obstructive Pulmonary Disease. 2003; 290:2721-9. Ferguson, G and Cherniack, R. Current Concepts: Management of Chronic Obstructive Pulmonary Disease. NEJM. 1993; 328:1017-22. Liu XL, Tan JY, Wang T, Zhang Q, Zhang M, Yao LQ, et al. Effectiveness of home-based pulmonary rehabilitation for patients with chronic obstructive pulmonary disease: a meta-analysis of randomized controlled trials. Rehabil Nurs. 2014 Jan-Feb; 39(1):36-59. Stephens, M and Yew, K. Diagnosis of Chronic Obstructive Pulmonary Disease. Am Fam Physician. 2008; 78:87-92. Sutherland, E and Cherniack, R. Management of Chronic Obstructive Pulmonary Disease. NEJM. 2004; 350:2689-97. 8

Clinical Trials Searches on February 17, 2014 using the terms pulmonary OR lung Open Studies Exclude Unknown Interventional Studies rehabilitation OR exercise Retrieved 195 relevant clinical trials. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for Pulmonary Rehabilitation Services (240.8). [Centers for Medicare and Medicaid Services (CMS) Web site] Original: 9/25/07. Available at: http://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=320&ver=1 Although services that make up pulmonary rehabilitation individually may be covered under Medicare and fall into various applicable benefit categories, the Centers for Medicare & Medicaid Services (CMS) has determined that the Social Security Act (the Act) does not expressly define a comprehensive Pulmonary Rehabilitation Program as a Part B benefit. In addition, respiratory therapy services are identified as covered services under the Comprehensive Outpatient Rehabilitation Facility benefit and defined in 42 CFR 410.100(e)(1) to (2)(vi). Local Coverage Determinations L31593 Respiratory Therapy (Respiratory Care) South Carolina http://www.cms.gov/medicare-coveragedatabase/details/lcd-details.aspx?lcdid=31593&ver=37&contrid=226&contrver=1 Commonly Submitted Codes: Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill in accordance with those manuals. Revenue Code Description Comment 0948 Other Therapeutic Services - Pulmonary Rehabilitation ICD-9 Code Description Comment 135 Sarcoidosis 277.02 Cystic fibrosis with pulmonary manifestations D86.9, I-10 277.09 Cystic fibrosis with other manifestations 9

335.20 Amyotrophic lateral sclerosis 496 Chronic obstructive pulmonary disease and allied conditions J44.9 COPD unspecified, I-10 494.0 Bronchiectasis without acute exacerbation 494.1 Bronchiectasis with acute exacerbation 493.00 493.92 Extrinsic asthma unspecified Asthma unspecified with (acute) exacerbation 494.0-494.1 Bronchiectasis without acute exacerbation Bronchiectasis with acute exacerbation 516.31 Idiopathic Pulmonary fibrosis V42.6 Lung replaced by transplant ICD-10 Code Description Comment J40-J47 Chronic lower respiratory diseases J68.4 Pulmonary fibrosis (chronic) due to inhalation of chemicals, gases, fumes or vapors J84.1 Other interstitial pulmonary diseases with fibrosis J84.112 Idiopathic pulmonary fibrosis D86.0 Sarcoidosis of lung D86.9 Sarcoidosis, unspecified E84.0 Cystic fibrosis with pulmonary manifestations G12.21 Amyotrophic lateral sclerosis Z48.24 Encounter for aftercare following lung transplant HCPCS Code Description Comment S9473: G0302 Pulmonary rehabilitation program, non-physician provider, per diem Preoperative pulmonary surgery services for preparation for LVRS, complete course of services, to include a minimum of 16 days of services Not on the Not on the G0303: Preoperative pulmonary surgery services for preparation for LVRS, 10 to 15 days of Not on the 10

G0304: G0305 G0424: services Preoperative pulmonary surgery services for preparation for LVRS, 1 to 9 days of services Post discharge pulmonary surgery services after LVRS, minimum of 6 days of services Pulmonary Rehabilitation, including exercise (includes monitoring), one hour per session, up to two sessions per day Not on the Not on the Not on the HCPCS Level II N/A Description Comment 11