National Medical Policy

National Medical Policy Subject: Policy Number: Pulmonary Rehabilitation NMP270 Effective Date*: July 2006 Updated: May 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for coverage guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Pulmonary Rehabilitation Services; Lung Volume Reduction Surgery (Reduction Pneumoplasty) (240.1): http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx X National Coverage Manual Citation Local Coverage Determination (LCD)* Respiratory Care (Respiratory Therapy): http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx Article (Local)* X Other Pulmonary Rehabilitation (PR) Services Pub 100-04 Medicare Claims Processing. Transmittal 1966. May 7, 2010: http://www.cms.gov/transmittals/downloads/r 1966CP.pdf None Use Health Net Policy Instructions Pulmonary Rehabilitation May 15 1

Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net, Inc. considers pulmonary rehabilitation medically necessary when all of the following are met: 1. Patient is referred by a pulmonologist or a cardiothoracic surgeon, depending on the individual s diagnosis, who is actively involved in the patient's care. Initial prescription must be specific as to treatment goals. 2. Initial diagnostic work-up prior to admission to rehabilitation program has been done, including appropriate pulmonary function studies, chest x-ray, ECG, arterial blood gas measurement at rest and during exercise, and 3. Pulmonary disability secondary to severe chronic obstructive pulmonary disease, and documented severe functional pulmonary disability is as evidenced by both of the following: a. Pulmonary function tests showing that FEV1/FVC is less than 55% of predicted b. A maximal pulmonary exercise stress test under optimal bronchodilator treatment which demonstrates a respiratory limitation to exercise with a maximal oxygen uptake (VO2 max) equal to or less than 20 ml/kg/min or about 5 mets; and 4. Symptomatic despite optimal medical management, which includes medication regimen and pulmonary toilet as documented in clinical notes; and a. The patient has quit all smoking for 3 months or longer; and b. Medically stable, and not limited by significant co-morbid concomitant conditions that would otherwise imminently contribute to deterioration of pulmonary status and /or undermine the expected benefits of the pulmonary rehabilitation program, e.g., most patients with active cancer, severe psychiatric disturbances (e.g., dementia or psychosis not adequately controlled by medication), substance abuse, congestive heart failure, claudication, myocardial infarction within previous 6 months, or angina pectoris not controlled by medication or appropriate procedures. Note: A typical course of pulmonary rehabilitation therapy is up to two (2) one-hour sessions per day, for up to 36 lifetime sessions (in some cases, up to 72 lifetime sessions). (i.e., Per Medicare Guidelines) Pulmonary Rehabilitation May 15 2

With justification, additional time may be needed. A single course of pulmonary rehabilitation per patient is allowed. Health Net, Inc. also considers pulmonary rehabilitation (PR) medically necessary as part of the *preparation and recovery from extensive surgical interventions, including but not limited to, the following: Lung transplantation; or Lung volume reduction surgery; or Post-operative states (e.g., s/p pneumonectomy with substantial pulmonary compromise, or s/p extensive abdominal surgery). *Note: The American Academy of Chest Physicians/American Academy of Cardiovascular and Pulmonary Rehabilitation Guidelines for Pulmonary Rehabilitation (ACCP/AACVPR) (2004, updated in 2007) state: Even patients with severe disease can benefit if they are selected appropriately and if realistic goals are set. The beneficial effects of pulmonary rehabilitation have been show only in studies of patients with COPD. Additional conditions appropriate for pulmonary rehabilitation programs when guidelines have been met are: Chronic asthmatic bronchitis or emphysema Cystic fibrosis Health Net, Inc. considers entry into a pulmonary rehabilitation program not medically necessary for patients with any of the following: 1. Significant limiting non-pulmonary or unstable medical conditions (e.g., CHF, substance abuse); 2. Patients with very severe pulmonary impairment as evidenced by dyspnea at rest, difficulty in conversation (monosyllabic answers), inability to work, cessation of most of all usual activities making the patient homebound are not appropriate candidates for full pulmonary rehabilitation programs, but may benefit from a limited program; 3. Other reasons that will likely render the benefits from the program unnecessary (i.e., a documented history of noncompliance, or severe psychiatric disturbances not adequately controlled by therapy, which could also contribute to noncompliance); 4. Inpatient pulmonary rehabilitation, unless inpatient care is otherwise necessary for another or related condition. A licensed physician who has training and experience in the treatment of patients with pulmonary disease will order, supervise, guide and direct each patient s PR plan of care. The initial physician s order will serve as certification for the first (1st) thirty (30) days. Thereafter, recertification for Occupational Therapy (OT) and Physical Therapy (PT) services is required every thirty (30) days. The PR physician or attending physician will certify the following prior to the initiation of PR services: 1. That a physical examination performed within the last ninety (90) days indicates that the patient is capable of participating in the plan of care. 2. That the patient is willing to cooperate and participate in the plan of care. Pulmonary Rehabilitation May 15 3

3. That the patient has quit smoking or will participate in smoking cessation activities prior to or during he course of PR services. (The patient should be asked to commit to this issue in writing) If the patient is receiving PR services beyond thirty (30) days, the physician must document that the patient remains capable of participation and provide clinical information demonstrating a continued benefit. An exacerbation or new complications (e.g., disease worsening, beginning use of supplemental oxygen, chronic hypercapnia, respiratory failure, use of oxygen at night or non-invasive ventilation, etc.), may justify additional participation in PR. A limited number of PR sessions may be considered medically necessary following a reassessment of the patient. Medical record documentation must support the need for the additional PR sessions. The supervising PR physician or the referring physician must provide orders to initiate PR treatment. All treatment orders for PR therapies must include all of the following: 1. Be specific as to the type, frequency, and duration of the procedure, modality, or activity. 2. Verbal and telephone orders must be co-signed and dated by the physician prior to billing the claim. 3. A blanket pulmonary rehabilitation (PR) order is not acceptable. PR services use a physician directed multidisciplinary approach with Respiratory Care Practitioners (RCPs), Registered Nurses (RNs), Physical Therapists (PTs), and Occupational Therapists (OTs), or any combination of these services. A duplication of services occurs when there is a direct overlap of services, or where a single service can provide the care. When there is an order for the same treatment modality or procedure for multiple clinicians (e.g., therapeutic exercise, breathing retraining), each clinician is expected to provide skilled treatment that reflects their unique skills and knowledge without exceeding the patient s skilled care needs. The treatment is directed toward each clinician s patient-specific goals. This is critical to establish that the services provided by various disciplines are reasonable, necessary, and distinct from each other. Frequency, duration, goals, and measurable objectives of each service provided are to be clearly documented. It may be reasonable and necessary for multiple clinicians on physician s order, to address a patient s particular needs. If so, then each clinician must perform a unique, individualized skilled evaluation within their scope of practice and in their specific area of expertise. Each initial evaluation will identify the problems, develop a specific plan of treatment, and set specific goals. All documentation must demonstrate clinical rationale for skilled intervention. Clinicians are required to document all activities, tasks, instruction, and treatment provided. This documentation must be done each time the patient receives any PR service. Team Conferences are to occur at the beginning and end of PR. Team conferences may occur during rehabilitation as needed. At these conferences the patient s progress toward achieving the short-term goals should be assessed. Pulmonary Rehabilitation May 15 4

Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date. ICD-9 Codes 135 Sarcoidosis 277.00 Cystic fibrosis without mention of meconium ileus 491.0 Simple chronic bronchitis 491.1 Mucopurulent chronic bronchitis 491.20 Obstructive chronic bronchitis without mention of acute exacerbation 491.8 Other chronic bronchitis 492.0 Emphysematous bleb - other emphysema 492.8 493.20 Chronic obstructive asthma without mention of status asthmaticus 494 Bronchiectasis 494.1 Bronchiectasis with acute exacerbation 496 Chronic airway obstruction (COPD), not elsewhere classified 500 Coal workers' pneumoconiosis 501 Asbestosis 502 Pneumoconiosis due to other silica or silicates 503 Pneumoconiosis due to other inorganic dust 504 Pneumonopathy due to inhalation of other dust 505 Pneumoconiosis, unspecified 506.4 Chronic respiratory conditions due to fumes and vapors 506.9 Unspecified respiratory conditions due to fumes and vapors 508.1 Chronic and other pulmonary manifestations due to radiation 515 Postinflammatory pulmonary fibrosis 516.0 Pulmonary alveolar proteinosis 516.2 Pulmonary alveolar microlithiasis 516.3 Idiopathic fibrosing alveolitis 516.8 Other specified alveolar and parietoalveolar pneumonopathies 518.1 Intersitial emphysema 518.89 Other disease of lung, not elsewhere classified ICD-10 Codes D86.0 Sarcoidosis of lung E84.0 Cystic fibrosis with pulmonary manifestations J41.0-J41.8 Simple and mucopurulent chronic bronchitis J43.0-J43.9 Emphysema Pulmonary Rehabilitation May 15 5

J44.0-J44.9 Other chronic obstructive pulmonary disease J47.0-J47.9 Bronchiectasis J60 Coalworker's pneumoconiosis J62.0-J62.8 Pneumoconiosis due to dust containing silica J63.0-J63.6 Pneumoconiosis due to other inorganic dusts J64 Unspecified pneumoconiosis J66.0-J66.8 Airway disease due to specific organic dust J68.4 Chronic respiratory conditions due to chemicals, gases, fumes and vapors J70.1 Chronic and other pulmonary manifestations due to radiation J84.01-J84.09 Alveolar and parieto-alveolar conditions J84.10 Pulmonary fibrosis, unspecified J84.89 Other specified interstitial pulmonary diseases J98.2 Interstitial emphysema J98.4 Other disorders of lung CPT Codes N/A HCPCS Codes G0237 Therapeutic procedures to increase strength or endurance of respiratory muscles, face-to-face, one-on-one, each 15 minutes (includes monitoring) G0238 Therapeutic procedures to improve respiratory function, other than described by G0237, face-to-face, one-on-one, each 15 minutes (includes monitoring) G0239 Therapeutic procedures to improve respiratory function or increase strength or endurance of respiratory muscles, two or more individuals (includes monitoring) G0424 Pulmonary rehabilitation, including exercise (includes monitoring) one hour, per session, up to two sessions per day S9473 Pulmonary rehabilitation program, non-physician provider, per diem Scientific Rationale Update May 2015 Wilson et al (2015) reported that pulmonary rehabilitation (PR) provides benefit for patients with chronic obstructive pulmonary disease (COPD) in terms of quality of life (QoL) and exercise capacity; however, the effects diminish over time. They sought to evaluate a maintenance program for patients who had completed PR. 148 patients with COPD who had completed at least 60% of a standard PR program were randomized and data are available for 110 patients. Patients had greater than 20 pack year smoking history and less than 80% predicted forced expiratory volume in 1 s but no other significant disease or recent respiratory tract infection. Patients were randomized to receive a maintenance program or standard care. The maintenance programconsisted of 2 h (1 h individually tailored exercise training and 1 h education program every 3 months for 1 year). The Chronic Respiratory Questionnaire (CRQ) (primary outcome), endurance shuttle walk test (ESWT), EuroQol (EQ5D), hospital anxiety and depression score (HADS), body mass index (BMI), body fat, activity levels (overall score and activity diary) and exacerbations were assessed before and after 12 months. There was no statistically significant difference between the groups for the change in CRQ dyspnoea score (primary end point) at 12 months which amounted to 0.19 (-0.26 to 0.64) units or other domains Pulmonary Rehabilitation May 15 6

of the CRQ. There was no difference in the ESWT duration (-10.06 (-191.16 to 171.03) seconds), BMI, body fat, EQ5D, MET-minutes, activity rating, HADS, exacerbations or admissions. The authors concluded a maintenance program of three monthly 2 h sessions does not improve outcomes in patients with COPD after 12 months. We do not recommend that our maintenance program is adopted. Other methods of sustaining the benefits of PR are required. Shakouri et al (2015) reported that prevention of pulmonary complications after coronary artery bypass graft is attended as a very important issue. The aim of this study was to evaluate the role of pulmonary rehabilitation before surgery for reducing the risk of pulmonary complications after surgery. In a randomized clinical trial, 60 patients undergoing heart surgery were randomly divided into two groups A and B. Chest physiotherapy was performed before and after surgery on group A patients however it was done on group B's, only after surgery. Effects of preoperative pulmonary rehabilitation were compared between two groups, using spirometry and arterial blood gas (ABG). Thirty nine males (65%) and 21 females (35%) with mean age of 8.10 ± 9.56 were analyzed. The mean differences were statistically significant for predicted forced vital capacity (FVC) (CI 95%:1.3 to 8.7) and Predicted Peak Flow indices (PEF) (CI 95%: 1.9 to 9.4) of spirometry indicator, PCO2 index (of ABG parameter) (CI 95%: 1.4 to 8.9) and mean oxygen saturation (mean Spo2) (CI 95%: 0.6 to 1.7) of ABG index in two groups. The authors concluded the performance of pulmonary rehabilitation program before surgery is recommended, as it may result in the reduction of complications of heart surgery. Scientific Rationale Update May 2014 Hjalmarsen et al (2014) examined retrospective survival in elderly chronic obstructive pulmonary disease (COPD) patients receiving three different pulmonary rehabilitation (PR) programs. 193 patients receiving PR were studied with lifetable and Cox regression analyses. Forced expiratory volume in 1 second (FEV1) % pred. was significantly different in the in-patient (n=72), out-patient (n=72), and maintenance group (n=49) [mean 54.5 (21.8), 52.2 (17.7), and 42.9 (15.0), respectively (p=0.004)]. PR days were 30.3 (20.4), 18.9 (10.4) and 30.0 (20.3), respectively (p<0.001). Median survival rate was nine years in the in-patient, eight years in the out-patient and seven years in the maintenance group. Hospital stays and days were significantly increased in the maintenance group compared with the other groups (p=0.003 and 0.010, respectively). The impact of evaluated variables on survival in the three PR groups was significant for age, FEV1 as well as the use of long-term oxygen therapy (LTOT) (HR 1.06, for five years, p<0.001, HR 0.98, p=0.01, and HR 2.18, p=0.005, respectively). Authors concluded the COPD patients in the maintenance group showed a worse survival, but after correction for gender, age and severity of obstruction, the difference was not statistically significant. Mujovic et al (2014) assessed the effects of preoperative pulmonary rehabilitation (PPR) on preoperative clinical status changes in patients with chronic obstructive pulmonary disease (COPD) and non-small cell lung cancer (NSCLC), and net effects of PPR and cancer resection on residual pulmonary function and functional capacity. The prospective single group study included 83 COPD patients (62 ±8 years, 85% males, FEV1 = 1844 ±618 ml, Tiffeneau index = 54 ±9%) with NSCLC, on 2-4-week PPR, before resection. Pulmonary function, and functional and symptom status were evaluated by spirometry, 6-minute walking distance (6MWD) and Borg scale, on admission, after PPR and after surgery. Following PPR significant improvement was registered in the majority of spirometry parameters (FEV1 by 374 ml, p < 0.001; Pulmonary Rehabilitation May 15 7

VLC by 407 ml, p < 0.001; FEF50 by 3%, p = 0.003), 6MWD (for 56 m, p < 0.001) and dyspneal symptoms (by 1.0 Borg unit, p < 0.001). A positive correlation was identified between preoperative increments of FEV1 and 6MWD (r s = 0.503, p = 0.001). Negative correlations were found between basal FEV1 and its percentage increment (r s = -0.479, p = 0.001) and between basal 6MWD and its percentage change (r s = -0.603, p < 0.001) during PPR. Compared to basal values, after resection a significant reduction of most spirometry parameters and 6MWD were recorded, while Tiffeneau index, FEF25 and dyspnea severity remained stable (p = NS). Investigators concluded preoperative pulmonary rehabilitation significantly enhances clinical status of COPD patients before NSCLC resection. Preoperative increase of exercise tolerance was the result of pulmonary function improvement during PPR. The beneficial effects of PPR were most emphasized in patients with initially the worst pulmonary function and the weakest functional capacity. Cheng et al (2014) evaluated sixty-four patients with COPD in a 12-week, 2 sessions-per-week, hospital-based PR program. Baseline and post-pr status were evaluated by spirometry, HRV, health-related quality of life (HRQL, St. George's Respiratory Questionnaire, SGRQ), cardiopulmonary exercise test, respiratory muscle strength, and dyspnea Borg's scale. After PR, there were significant improvements in the time and frequency domains of HRV with increased standard deviation of the normal R-R intervals, difference between adjacent normal R-R intervals within a given time minus one, high-frequency and decreased low-frequency, as well as concurrent improvements in HRQL, exercise capacity, dyspnea score, and respiratory muscle strength (all p < 0.05). Investigators concluded PR results in significant improvements in autonomic function, with concurrent improvements in HRQL and exercise capacity. Salhi et al (2014) investigated the effect of radical treatment and post-treatment pulmonary rehabilitation on muscle mass and strength in patients with lung cancer and the relationship between muscle mass and strength. Lung cancer patients, candidate for radical treatment, were randomly (2:1) allocated after radical treatment to either standard follow up (CON) or a 12-week rehabilitation training program (RT). Muscle mass was estimated by bioelectric impedance and CT-scan. Muscle strength was estimated by measuring quadriceps force (QF) with a hand held dynamometer. All variables were measured before (M1) and after radical treatment (M2), and at the earliest 12 weeks after randomization (M3). Data are presented as means with standard deviation. 45 lung cancer patients (age: 65 years (9)) participated in the study. At M2, both muscle cross sectional area (MCSA) and QF were significantly decreased (p<0.05). 28 patients were randomized. 13/18 RT and 9/10 CON patients ended the trial. At M3, RT-patients improved significantly their MCSA compared to CON-patients (ΔMCSA: 6cm(2) (6) (p=0.003) vs. 1cm(2) (11) (p=0.8)). Authors concluded muscle mass and strength: (1) are decreased at presentation in a substantial part of lung cancer patients; (2) are significantly negatively affected by radical treatment and (3) completely recover after a 12 week structured rehabilitation program, whereas a further decline was observed in CONpatients. Scientific Rationale Update May 2013 Wadell et al (2013) examined effects on the major domains of dyspnea and their interaction with physiological training effects in a randomized, controlled study conducted in 48 subjects with COPD. Subjects received either 8-weeks of pulmonary rehabilitation (PR) or usual care (CTRL). Pre- and post-intervention assessments Pulmonary Rehabilitation May 15 8

included: sensory-perceptual (i.e., exertional dyspnea intensity, dyspnea descriptors at end-exercise), affective (i.e., intensity of breathing-related anxiety during exercise, COPD self-efficacy, walking self-efficacy) and impact (i.e., activity-related dyspnea measured by the Baseline/Transition Dyspnea Index, Chronic Respiratory Questionnaire dyspnea component, St. George's Respiratory Disease Questionnaire activity component) domains of dyspnea; functional performance (i.e., 6-minute walk, endurance shuttle walk); pulmonary function; and physiological measurements during constant work rate cycle exercise at 75% of the peak incremental work rate. Forty-one subjects completed the study: PR (n = 17) and CTRL (n = 24) groups were well matched for age, sex, body size and pulmonary function. There were no significant between-group differences in pre- to post-intervention changes in pulmonary function or physiological parameters during exercise. After PR versus CTRL, significant improvements were found in the affective and impact domains but not in the sensory-perceptual domain of dyspnea. Investigators concluded, clinically meaningful improvements in the affective and impact domains of dyspnea occurred in response to PR in the absence of consistent physiological training effects. Reis et al (2013) sought to determine the effects of an outpatient pulmonary rehabilitation program on exercise tolerance, dyspnea, hemodynamic variables and quality of life in a case series study. A convenience sample of COPD patients was enrolled in this study. The intervention consisted of a 96-wk exercise training program, including aerobic training, upper-limb exercises and inspiratory muscle training. Pulmonary function tests, blood biochemistry, six-minute walking distance test and health-related quality of life were recorded at baseline and after completion of the 6th, 12th, 18th, 24th months. Forty one consecutive COPD patients were recruited and thirty six completed the study. There was a significant improvement in hemodynamics, demonstrated by the gradual reduction in heart rate, blood pressure and MvO2 (double product) starting from the 12th month. Lipid profile showed a reduction of low density lipids and an increase of the high density lipids levels starting from the 6th month. Exercise tolerance, dyspnea, respiratory muscle strength and quality of life also improved starting from the 6th month. Investigators concluded that a 24-month pulmonary rehabilitation program leads to a progressive improvement in quality of life, dyspnea and exercise tolerance, and reduces cardiovascular risk factors in patients with chronic obstructive pulmonary disease. They noted further the study suggests that long-term pulmonary rehabilitation programs can result in further improvements in the aforementioned cardiorespiratory variables. Beauchamp et al (2013) performed a systematic review to determine the effect of supervised exercise programs after primary PR on exercise capacity and healthrelated quality of life (HRQL) in individuals with COPD. Randomized controlled trials (RCTs) of post-rehabilitation supervised exercise programs versus usual care for individuals with COPD were identified after searches of six databases and reference lists of appropriate studies. Two reviewers independently assessed study quality. Standardized mean differences (SMD) with 95% confidence intervals (CI) were calculated using a fixed-effect model for measures of exercise capacity and HRQL. Seven RCTs, with a total of 619 individuals with moderate to severe COPD, met the inclusion criteria. At 6-months 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), which was not sustained at 12 months (SMD -0.09 95%CI -0.29 to 0.11). There was no difference between post-rehabilitation interventions and usual care with respect to HRQL at any time-point. Reviewers concluded supervised exercise Pulmonary Rehabilitation May 15 9

programs after primary PR appear to be more effective than usual care for preserving exercise capacity in the medium-term but not the long-term. In this review, there was no effect on HRQL. The small number of studies precludes a definitive conclusion as to the impact of post rehabilitation exercise maintenance on longer term benefits in individuals with COPD. Vandenbos et al (2013) investigated the safety, feasibility and effectiveness of an inpatient pulmonary rehabilitation program (i-pr) after lung resection (LR) for cancer. Between January 2007 and December 2009, they conducted a prospective observational study on patients admitted at a single institution. An i-pr was offered to all patients. They completed respiratory function tests and a quality of life (QoL) questionnaire at the start and after completing the i-pr. During the study, 154 out of 175 patients who underwent LR and who were admitted in the center followed an i-pr. The remaining 21 patients were excluded because of emergency rehospitalisation (10 patients), anticipated departure (six patients) or refusal to participate (five patients). Most functional parameters in the 154 treated patients improved between the beginning and the end of their stay: FVC (69.9% versus 79.6%; P<0.0001); FEV(1) (61.2% versus 69.9%; P<0.0001); timed walk-6mwt (356 m versus 444 m; P<0.0001) and constant work cycle ergometry test (281 s versus 683 s; P<0.0001). Also, the EORTC QLQ-C30 and the EORTC QLQ-LC13 improved during the stay, especially global health status (50.5 versus 64.5; P<0.0001). Investigators concluded postoperative PR is safe and could positively impact on functional status and QoL among this population. Scientific Rationale Update May 2012 Lung volume reduction surgery is performed for patients with severe functionlimiting emphysema with the goal of improving gas exchange, exercise capacity, lung function, and quality of life. Candidates for lung volume reduction surgery, patients who have had lung volume reduction surgery and lung transplantation and post lung transplantation patients may be prescribed an inpatient or outpatient pulmonary rehabilitation program, depending on the patient's goals and medical stability. Per Hayes, Medical Technology Directory on Pulmonary Rehabilitation, Pulmonary Rehabilitation is also routinely offered to patients as part of the evaluation of, preparation for, and recovery from surgical interventions such as lung transplantation and lung volume reduction surgery. The American Academy of Chest Physicians/American Academy of Cardiovascular and Pulmonary Rehabilitation Guidelines for Pulmonary Rehabilitation (ACCP/AACVPR) state: Even patients with severe disease can benefit if they are selected appropriately and if realistic goals are set. Pulmonary rehabilitation is typically a pre-and post-operative intervention for patients undergoing lung transplantation and lung volume reduction surgery (LVRS). Pulmonary rehabilitation prior to pulmonary surgery may stabilize or improve patients exercise tolerance, as well as teach techniques that will assist with postoperative recovery. Scientific Rationale Update July 2010 Pulmonary rehabilitation is a broad therapeutic concept. It is defined by the American Thoracic Society and the European Respiratory Society as an evidence- Pulmonary Rehabilitation May 15 10

based, multidisciplinary, and comprehensive intervention for patients with chronic respiratory diseases who are symptomatic and often have decreased daily life activities. Integrated into the individualized treatment of the patient, pulmonary rehabilitation is designed to reduce symptoms, optimize functional status, increase participation, and reduce health care costs by stabilizing or reversing systemic manifestations of the disease. (2010) National Institute for Clinical Excellence (NICE) Has an updated recommendation as noted below: Pulmonary rehabilitation should be made available to all appropriate people with COPD including those who have had a recent hospitalization for an acute exacerbation. Geddes et al. (2008) completed a study to update an original systematic review to determine the effect of inspiratory muscle training (IMT) on inspiratory muscle strength and endurance, exercise capacity, dyspnea and quality of life for adults with chronic obstructive pulmonary disease (COPD). Randomized controlled trials, with adults with stable COPD, comparing inspiratory muscle strength (IMT) to sham IMT or no intervention, low versus high intensity IMT, and different modes of IMT were included. Nineteen of 274 articles in the original search met the inclusion criteria. The updated search revealed 17 additional articles; 6 met the inclusion criteria, all of which compared targeted, threshold or normocapneic hyperventilation IMT to sham IMT. An update of the sub-group analysis comparing IMT versus sham IMT was performed with 10 studies from original review and 6 from the update. Sixteen meta-analyses are reported. Results demonstrated significant improvements in inspiratory muscle strength (PI(max), PI(max) % predicted, peak inspiratory flow rate), inspiratory muscle endurance (RMET, inspiratory threshold loading, MVV), exercise capacity (Ve(max), Borg Score for Respiratory Effort, 6MWT), Transitional Dyspnea Index (focal score, functional impairment, magnitude of task, magnitude of effort), and the Chronic Respiratory Disease Questionnaire (quality of life). Results suggest that targeted, threshold or normocapneic hyperventilation IMT significantly increases inspiratory muscle strength and endurance, improves outcomes of exercise capacity and one measure of quality of life, and decreases dyspnea for adults with stable COPD. In a Cochrane review, Puhan et al. (2009) completed randomized controlled trials comparing pulmonary rehabilitation of any duration after exacerbation of COPD with conventional care. Pulmonary rehabilitation programs were needed to include at least physical exercise. Control groups received conventional community care without rehabilitation. The authors calculated pooled odds ratios and weighted mean differences (WMD) using fixed-effects models. We requested missing data from the authors of the primary studies. They identified six trials including 219 patients. Pulmonary rehabilitation significantly reduced hospital admissions (pooled odds ratio 0.13 [95% CI 0.04 to 0.35], number needed to treat (NNT) 3 [95% CI 2 to 4], over 34 weeks) and mortality (pooled odds ratio 0.29 [95% CI 0.10 to 0.84], NNT 6 [95% CI 5 to 30]over 107 weeks). Effects of pulmonary rehabilitation on health-related quality of life were well above the minimal important difference (weighted mean differences for dyspnea, fatigue, emotional function and mastery domains of the Chronic Respiratory Questionnaire between 1.15 (95% CI: 0.94, 1.36) and 1.88 (95% CI:1.67, 2.09) and between -9.9 (95% CI:-18.05, -1.73) and -17.1 (95% CI: - 23.55, -10.68) for total, impact and activity limitation domains of the St. Georges Pulmonary Rehabilitation May 15 11

Respiratory Questionnaire). In all trials, pulmonary rehabilitation improved exercise capacity (60-215 meters in six-minute or shuttle walk tests). No adverse events were reported (two studies). AUTHORS' CONCLUSIONS: Evidence from small studies of moderate methodological quality suggests that pulmonary rehabilitation is a highly effective and safe intervention to reduce hospital admissions and mortality and to improve health-related quality of life in COPD patients after suffering an exacerbation. (2009) U.S. Preventive Services Task Force (USPSTF) developed Clinical Guidelines for Counseling and Interventions to Prevent Tobacco Use and Tobacco-Caused Disease in Adults and Pregnant Women. The USPSTF reviewed new evidence in the U.S. Public Health Service's 2008 clinical practice guideline and determined that the net benefits of tobacco cessation interventions in adults and pregnant women remain well established. The USPSTF Reaffirmation Recommendation Statement for 2009 is noted below: Ask all adults about tobacco use and provide tobacco cessation interventions for those who use tobacco products. (Grade A recommendation) Ask all pregnant women about tobacco use and provide augmented, pregnancytailored counseling for those who smoke. (Grade A recommendation) Covered Services (Medicare) (Services Prior to 9/25/2007) PR services are defined as those services that are prescribed by a physician for the assessment, diagnostic evaluation, treatment, management, and monitoring of patients with deficiencies and abnormalities of pulmonary function. Participation in PR services as, outlined in this document, may occur for a period not to exceed twelve (12) hours per week for six (6) weeks. Services beyond six (6) weeks will be reviewed on an individual basis to determine medical necessity to continue PR as a skilled service. It is recognized that individuals benefit from PR at varying length of time. Therefore, it is expected that services would be discontinued at any time that maximum clinical benefit is reached. All PR services must meet all of the following criteria: 1. Be ordered by a physician and qualify as a covered service. 2. Be reasonable and necessary for the diagnosis and/or treatment of a subacute or chronic pulmonary illness. 3. Be consistent with the nature and severity of the individual s symptoms and diagnosis. 4. Be reasonable in terms of procedure/modality, amount, frequency and duration of the treatment. 5. Be generally accepted by the professional community as being safe and effective treatment. 6. Be of a level of complexity, or the condition must be such, that the services can be rendered only by a skilled clinician. 7. Be delivered by qualified health professionals in accordance with state and federal regulations. 8. Individual patient training may occur in groups of four (4) conducted by a qualified health professional or groups of six (6) if an aide is also present. 9. Not exceed the patient s particular PR needs. 10. Promote recovery, restore function, and ensure safety affected by illness or injury. Pulmonary Rehabilitation May 15 12

11. Have an expectation that there will be measurable improvement of the patient s condition in a reasonable and generally predictable period of time, and demonstrate documented practical improvement. Non-Covered Services (Medicare) 1. Non-individualized (i.e., generalized) treatment, education and training. 2. Routine psychological screening and/or routine psychological therapy. 3. Duplication of services between OT, PT, RCP, and/or RN. 4. Treatment that exceeds the patient s needs for the identified condition. 5. Routine, non-skilled and/or maintenance care, such as: repetitive services for chronic baseline conditions, plateau in patient s progress toward goals, inability to sustain gains, no overall improvement, or generalized exercise that could be provided in a nonclinical setting and/or level of care. 6. Services delivered to patients who have poor rehabilitation potential. 7. Treatment that is not reasonable and necessary due to a lack of significant objective findings in preliminary pulmonary diagnostic testing. 8. Therapy groups with greater than six (6) patients and/or not individualized to each patient s goals. 9. Routine follow-up visits. 10. Viewing of films or videotapes; listening to audiotapes; completing interactive computer programs; any supervised or independent technology-based instruction. Reasons for Denial 1. PR services when a patient would be expected to spontaneously return to their prior level of function without skilled therapeutic intervention. 2. Services for maintenance of a chronic baseline condition. 3. Services to merely maintain a functional level. 4. Patients with acute and/or unstable disease. 5. Patients incapable of participating in PR due to mental or physical limitations. 6. Patients where documentation does not support measurable benefit. 7. Patients who are unable or unwilling to use training. Exclusions Pulmonary rehabilitation The following are excluded from coverage under the Medicare Program for pulmonary rehabilitation and are not reimbursable directly or indirectly: 1. Exercise equipment or supplies. 2. Biofeedback services for relaxation. Discharge Criteria and Follow-Up A patient should be discharged from PR services when the documentation shows the following: 1. The PR treatment goals are achieved. 2. There is minimal or no potential for material gains or significant progress. 3. The patient is non-compliant with the established plan of care, or 4. The patient no longer requires skilled PR services Ongoing medical care is the responsibility of the primary care physician. If the patient s condition changes, the physician may order new components of PR Pulmonary Rehabilitation May 15 13

treatment. Under the Medicare Program, it is not considered reasonable or necessary for therapists to routinely screen patients for a potential need for skilled services. Note: Patients with other severe or chronic pulmonary disorders (e.g., lung cancer, neuromuscular diseases, lung transplant, scoliosis, kyphoscoliosis, etc.) may benefit from PR. Some patients may not meet the criteria in this policy, yet still be appropriate for PR because of other severe or chronic disorders. All such cases will be reviewed on an individual basis. The following costs are not line item billable. They are considered indirect costs of providing PR services: 1. Physician, pharmacist, and dietitian lectures 2. Nutritional counseling 3. Social Services 4. Team and/or family conferences 5. Documentation time 6. Discharge Summaries 7. Educational books, pamphlets, audio/video tapes, CDs, DVDs, computer software, or any other materials not considered medical supplies. Medicare NCD for PULMONARY REHABILITATION Services (240.8) (Effective 9/25/2007. Implementation date 1/7/2008) Pulmonary Rehabilitation was defined in a 1999 joint statement of the American Thoracic Society and the European Respiratory Society as a multi-disciplinary program of care for patients with chronic respiratory impairment that is individually tailored and designed to optimize physical and social performance and autonomy and an evidence-based, multidisciplinary, and comprehensive intervention for patients with chronic respiratory diseases who are symptomatic and often have decreased daily life activities. Integrated into the individualized treatment of the patient, Pulmonary Rehabilitation is designed to reduce symptoms, optimize functional status, increase participation, and reduce health care costs through stabilizing or reversing systematic manifestations of the disease. 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 Rehabililitation Facility benefit and defined in 42 CFR 410.100(e)(1) to (2)(vi). The CMS has determined that a national coverage determination (NCD) for Pulmonary Rehabilitation is not appropriate at this time. Local contractors should continue to make decisions under 1862(a)(1)(A) of the Act through their local coverage determination (LCD) process or by case-by-case adjudication. See Heckler v. Ringer, 466 U.S. 602, 617 (1984) (Recognizing that the Secretary has discretion to either establish a generally applicable rule or to allow individual adjudication.). See also, 68 Fed. Reg. 63692, 63693 (November 7, 2003). Local Medicare Pulmonary Rehabilitation May 15 14

As noted above, there is no actual Medicare National Coverage Determination (NCD), for dates of service on or after 9/25/07 for Medicare members, for Pulmonary Rehabilitation. Scientific Rationale Initial Pulmonary rehabilitation (PR) is a multidisciplinary program for the long-term management of severe incapacitating pulmonary disease, e.g. asthma, emphysema, chronic bronchitis, chronic airflow obstruction, cystic fibrosis, bronchopulmonary dysplasia, or dyspnea. Pulmonary rehabilitation programs include exercise training, psychosocial support, and education to improve the patient s functioning and quality of life. The American College of Chest Physicians defines PR as "a multidimensional continuum of services directed to persons with pulmonary disease and their families, usually by an interdisciplinary team of specialists, with the goal of achieving and maintaining the individual's maximum level of independence and functioning in the community." PR is most useful for patients with moderately advanced or advanced chronic obstructive pulmonary disease (e.g., emphysema, chronic bronchitis, asthma - certain aspects may be helpful to patients with other disabling pulmonary disorders. These programs usually last 4 to 8 weeks, but may last up to 12 weeks when justified, with beneficial results, and include patient and family education; attention to appropriate prescribing of medicines including oxygen and immunizations; physical therapy including postural drainage, chest percussion, breathing retraining, pursed lip breathing; psychosocial support and intervention; vocational rehabilitation; exercise conditioning; team assessment; patient training; and followup. Team assessment includes input from a physician, respiratory care practitioner, nurse and psychologist, physical therapist, amongst others who may be appropriate to the care of an individual patient. Patient training includes breathing retraining, bronchial hygiene, medications, use of oxygen, and proper nutrition. Psychosocial intervention addresses support system and dependency issues. Exercise training includes strengthening and conditioning; e.g., stair climbing, inspiratory muscle training, treadmill walking, cycle training with or without ergometer, and supported and unsupported arm exercise training. Exercise conditioning is an essential part of pulmonary rehabilitation. A structured home or facility pulmonary rehabilitation program should be a concomitant to the basic program, and may include supervised home exercise conditioning. These patients are excellent case management program candidates. Beneficial effects for a six-month outpatient training program included improvements in 6-minute walking distance, maximal exercise performance, peripheral and respiratory muscle strength and quality of life persisting over 18 months (Troosters, et al). Stewart, et al found that an inpatient pulmonary rehabilitation program led to improved endurance and functional ambulation, decreased supplemental oxygen use, and fewer hospitalizations 1 year after discharge for patients with COPD. Review History July 2006 July 2010 Medical Advisory Council initial approval Update. Revisions of Medicare NCD added, as well as information regarding LCD. Codes updated. Pulmonary Rehabilitation May 15 15

June 2011 May 2012 July 2012 September 2012 May 2013 May 2014 May 2015 Update. Added Medicare Table with link to NCD and LCD. No revisions. Update. Added pulmonary rehabilitation as medically necessary as part of the preparation and recovery from surgical interventions including lung transplantation, lung volume reduction surgery, or post-operative states (e.g., thoracic, abdominal surgery). Added additional MLN site on Medicare table that was revised July 16, 2012. This notes that It is a covered benefit for the comprehensive pulmonary rehabilitation program, for Medicare patients with moderate to very severe COPD. Update. Added Medicare verbiage regarding time limits regarding a typical course of pulmonary rehabilitation. Update no revisions. Code updates. Update no revisions. Update no revisions This policy is based on the following evidence-based guidelines: 1. American Association of Respiratory Therapists: Pulmonary Rehabilitation. Resp Care 47(5):617-25, 2002 2. American Association of Respiratory Therapists: Discharge Planning for the Respiratory Care Patient. Respir Care 40(12):1308-12, 1995 3. American College of Chest Phys./Am. Assoc. of Cardiovascular & Pulmonary Rehabilitation (AACP/AACVPR) Pulmonary Rehabilitation Guidelines Panel: Pulmonary Rehabilitation. Chest. 1997;112(5):1363-1396. 4. American Thoracic Society: Pulmonary Rehabilitation. Am J Respir Crit Care Med (159) 1666-82, 1999 5. American Thoracic Society Standards for the Diagnosis and Management of Patients with COPD. 6. National Institute for Health and Clinical Excellence (NICE): COPD. 2004. 7. American Association for Respiratory Care (AARC). AARC clinical practice guideline: Pulmonary rehabilitation. Dallas,TX: American Association for Respiratory Care (AARC); 2002. 8. British Thoracic Society. Pulmonary rehabilitation. British Thoracic Society Standards of Care Subcommittee on Pulmonary Rehabilitation. Thorax. 2001;56(11):827-834. http://thorax.bmjjournals.com/cgi/content/full/56/11/827 9. Abdulwadud O. Outpatient multidisciplinary pulmonary rehabilitation program for patients with chronic respiratory conditions. Clayton, Victoria, Australia: Centre for Clinical Effectiveness (CCE); 2002. 10. Eaton T, Young P, Fergusson W, et al. Does early pulmonary rehabilitation reduce acute health-care utilization in COPD patients admitted with an exacerbation? A randomized controlled study. National Institute for Clinical Excellence (NICE). 2010. National Clinical Guideline Centre. 11. U.S. Preventive Services Task Force (USPSTF). Clinical Guidelines. Counseling and Interventions to Prevent Tobacco Use and Tobacco-Caused Disease in Adults and Pregnant Women: U.S. Preventive Services Task Force Reaffirmation Recommendation Statement. 2009. 12. American College of Chest Physicians. Pulmonary Rehabilitation. Joint ACCP/AACVPR Evidence-Based Clinical Practice Guidelines. Updated in 2007. Available at: Pulmonary Rehabilitation May 15 16

http://journal.publications.chestnet.org/issue.aspx?journalid=99&issueid=24351 &direction=p 13. Hayes. Medical Technology Directory. Pulmonary Rehabilitation. April 2002, updated 2007. Archived 2008. 14. Qaseem A, Wilt TJ, Weinberger SE, et al; American College of Physicians; American College of Chest Physicians; American Thoracic Society; European Respiratory Society. Diagnosis and management of stable chronic obstructive pulmonary disease: A clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011; 155(3):179-191. 15. National Institute of Clinical Excellence. Chronic obstructive pulmonary disease: Management of chronic obstructive pulmonary disease in adults in primary and secondary care (partial update). June 2010. Available at: http://www.nice.org.uk/guidance/cg101/chapter/key-priorities-forimplementation References Update May 2015 1. Atabaki A, Fine J, Haggerty M, et al. Effectiveness of Repeated Courses of Pulmonary Rehabilitation on Functional Exercise Capacity in Patients With COPD. 2. Cardiopulm Rehabil Prev. 2015 Apr 7 3. He M, Yu S, Wang L, Lv H, Qiu Z. Efficiency and safety of pulmonary rehabilitation in acute exacerbation of chronic obstructive pulmonary disease. Med Sci Monit. 2015 Mar 18;21:806-12. 4. Mkacher W, Mekki M, Tabka Z, Trabelsi Y. Effect of 6 Months of Balance Training During Pulmonary Rehabilitation in Patients With COPD. Cardiopulm Rehabil Prev. 2015 Mar 11 5. Shakouri SK, Salekzamani Y, Taghizadieh A, et al. Effect of respiratory rehabilitation before open cardiac surgery on respiratory function: a randomized clinical trial. J Cardiovasc Thorac Res. 2015;7(1):13-7. 6. Wheaton AG, Cunningham TJ, Ford ES, Croft JB. Employment and activity limitations among adults with chronic obstructive pulmonary disease - United States, 2013. MMWR Morb Mortal Wkly Rep. 2015 Mar 27;64(11):289-95. 7. Wilke S, Jones PW, Müllerova H, et al. One-year change in health status and subsequent outcomes in COPD. Thorax. 2015 May;70(5):420-5 8. Wilson AM, Browne P, Olive S, et al. The effects of maintenance schedules following pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomised controlled trial. BMJ Open. 2015 Mar 11;5(3):e005921 References Update May 2014 1. Borghi-Silva A, Mendes RG, Trimer R, et al. Potential effect of 6 vs 12-weeks of physical training on cardiac autonomic function and exercise capacity in chronic obstructive pulmonary disease. Eur J Phys Rehabil Med. 2014 Mar 5. 2. Cassidy S, Turnbull S, Gardani M, Kirkwood K. Attendance at pulmonary rehabilitation classes: An exploration of demographic, physiological and psychological factors that predict completion of treatment. Chron Respir Dis. 2014 Mar 21. 3. Cheng ST, Wu YK, Yang MC, et al. Pulmonary rehabilitation improves heart rate variability at peak exercise, exercise capacity and health-related quality of life in chronic obstructive pulmonary disease. Heart Lung. 2014 Mar 28. Pulmonary Rehabilitation May 15 17

4. Demeyer H, Burtin C, Van Remoortel H, et al. Standardizing the analysis of physical activity in patients with COPD following a pulmonary rehabilitation program. Chest. 2014 Mar 6. 5. Hjalmarsen A, Brenn T, Jongsma Risberg M, et al. Retrospective survival in elderly COPD patients receiving pulmonary rehabilitation; a study including maintenance rehabilitation. BMC Res Notes. 2014 Apr 3;7(1):210. 6. Incorvaia C, Russo A, Foresi A, et al. Effects of pulmonary rehabilitation on lung function in chronic obstructive pulmonary disease: the FIRST study. Eur J Phys Rehabil Med. 2014 Apr 2 7. Jackson RM, Gómez-Marín OW, Ramos CF, et al. Exercise Limitation in IPF Patients: A Randomized Trial of Pulmonary Rehabilitation. Lung. 2014 Apr 5. 8. Kaymaz D, Ergün P, Candemir I, et al. Pulmonary rehabilitation in interstitial lung diseases. Tuberk Toraks. 2013 Dec;61(4):295-302. 9. Mujovic N, Mujovic N, Subotic D, et al. Preoperative pulmonary rehabilitation in patients with non-small cell lung cancer and chronic obstructive pulmonary disease. Arch Med Sci. 2014 Feb 24;10(1):68-75. 10. Salhi B, Huysse W, Van Maele G, et al. The effect of radical treatment and rehabilitation on muscle mass and strength: A randomized trial in stages I-III lung cancer patients. Lung Cancer. 2014 Apr;84(1):56-61 11. Zanini A, Chetta A, Gumiero F, et al. Six-minute walking distance improvement after pulmonary rehabilitation is associated with baseline lung function in complex COPD patients: a retrospective study. Biomed Res Int. 2013;2013:483162. References Update May 2013 1. Beauchamp MK, Evans R, Janaudis-Ferreira T, et al. Systematic Review of Supervised Exercise Programs after Pulmonary Rehabilitation in Individuals with COPD. Chest. 2013 Feb 21. 2. Bhandari NJ, Jain T, Marolda C, ZuWallack RL. Comprehensive pulmonary rehabilitation results in clinically meaningful improvements in anxiety and depression in patients with chronic obstructive pulmonary disease. J Cardiopulm Rehabil Prev. 2013 Mar-Apr;33(2):123-7. 3. Dierich M, Tecklenburg A, Fuehner T, et al. The influence of clinical course after lung transplantation on rehabilitation success. Transpl Int. 2013 Mar;26(3):322-30. 4. Dyer CA, Harris ND, Jenkin Eet al. Activity levels after pulmonary rehabilitation - what really happens? Physiotherapy. 2012 Jul 9. 5. Grosbois JM, Le Rouzic O, Monge E, et al. Comparison of home-based and outpatient, hospital-based, pulmonary rehabilitation in patients with chronic respiratory diseases. Rev Pneumol Clin. 2013 Feb;69(1):10-7. 6. Hayton C, Clark A, Olive S, et al. Barriers to pulmonary rehabilitation: characteristics that predict patient attendance and adherence. Respir Med. 2013 Mar;107(3):401-7. 7. Lan CC, Chu WH, Yang MC, et al. Benefits of pulmonary rehabilitation in patients with COPD with normal exercise capacity. Respir Care. 2013 Jan 3. 8. Moore L, Hogg L, White P. Acceptability and feasibility of pulmonary rehabilitation for COPD: a community qualitative study. Prim Care Respir J. 2012 Dec;21(4):419-24. 9. Pasqua F, Alesii A, Geraneo K, et al. A pilot survey on the quality of life in respiratory rehabilitation carried out in COPD patients with severe respiratory failure: preliminary data of a novel Inpatient Respiratory Rehabilitation Questionnaire (IRRQ). Multidiscip Respir Med. 2012 Nov 20;7(1):46. Pulmonary Rehabilitation May 15 18

10. Reis LF, Guimarães FS, Fernandes SJ, et al. A long-term pulmonary rehabilitation program progressively improves exercise tolerance, quality of life and cardiovascular risk factors in patients with COPD. Eur J Phys Rehabil Med. 2013 Mar 13. 11. Román M, Larraz C, Gómez Aet al. Efficacy of pulmonary rehabilitation in patients with moderate chronic obstructive pulmonary disease: a randomized controlled trial. BMC Fam Pract. 2013 Feb 11;14:21. 12. Santus P, Bassi L, Radovanovic D, et al. Pulmonary Rehabilitation in COPD: A Reappraisal (2008-2012). Pulm Med. 2013;2013:374283. 13. Stigt JA, Uil SM, van Riesen SJ, et al. A randomized controlled trial of postthoracotomy pulmonary rehabilitation in patients with resectable lung cancer. J Thorac Oncol. 2013 Feb;8(2):214-21. 14. Soler X, Diaz-Piedra C, Ries AL. Pulmonary rehabilitation improves sleep quality in chronic lung disease. COPD. 2013 Apr;10(2):156-63. 15. Vandenbos F, Fontas É, Dunais B, et al. Pulmonary rehabilitation after lung resection for tumor - a feasibility study. Rev Mal Respir. 2013 Jan;30(1):56-61. 16. Wadell K, Webb KA, Preston ME, et al. Impact of Pulmonary Rehabilitation on the Major Dimensions of Dyspnea in COPD. COPD. 2013 Mar 28. References Update May 2012 1. Chapman KR, Rennard SI, Dogra A, et al. Long-term safety and efficacy of indacaterol, a long-acting β-agonist, in subjects with COPD: a randomized, placebo-controlled study. Chest 2011; 140:68 2. Ferguson GT, Make B. Management of stable chronic obstructive pulmonary disease. UpToDate. February 2, 2012. 3. Frontera: Essentials of Physical Medicine and Rehabilitation, 2nd ed. 2008. Chapter 141 Pulmonary Rehabilitation. John R. Bach, MD 4. Hanania NA, Celli BR, Donohue JF, Martin UJ. Bronchodilator reversibility in COPD. Chest 2011; 140:1055. 5. Puhan MA, Gimeno-Santos E, Scharplatz M, et al. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. updated 2011. 6. Worth H, Chung KF, Felser JM, et al. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med 2011; 105:571. References Update June 2011 1. Centers for Medicare & Medicaid Services (CMS). CMS Manual System. Pub 100-04 Medicare Claims Processing. May 7, 2010. Available at address: http://www.cms.gov/transmittals/downloads/r1966cp.pdf References Update July 2010 1. Mason: Murray and Nadel s Textbook of Respiratory Medicine, 5 th Edition. Components of a Comprehensive Pulmonary Rehabilitation Program. 2010. 2. Celi BR. Pulmonary Rehabilitation in COPD. UpToDate. January 21, 2010. 3. Sharma S, Arneja A. Pulmonary Rehabilitation, April 22, 2010. emedicine. Available at: http://emedicine.medscape.com/article/319885-overview 4. CMS. Centers for Medicare & Medicaid Services. LCD for Respiratory Care (Respiratory Therapy ) Originally effective 9/17/2009. Revisions effective 4/19/2010. Pulmonary Rehabilitation May 15 19

5. Eaton T, Young P, Fergusson W, et al. Does early pulmonary rehabilitation reduce acute health-care utilization in COPD patients admitted with an exacerbation? A randomized controlled study. Respirology. 2009;14(2):230-238. 6. Puhan M, Scharplatz M, Troosters T, et al. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2009;(1):CD005305. 7. ZuWallack R, Hedges H. Primary care of the patient with chronic obstructive pulmonary disease-part 3: pulmonary rehabilitation and comprehensive care for the patient with chronic obstructive pulmonary disease. Am J Med. 2008 Jul;121(7 Suppl):S25-32. 8. Celli BR. Update on the management of COPD. Chest. 2008 Jun;133(6):1451-62. 9. Barakat S, Michele G, George P, et al. Outpatient pulmonary rehabilitation in patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2008;3(1):155-62. 10. Geddes EL, O'Brien K, Reid WD, et al. Inspiratory muscle training in adults with chronic obstructive pulmonary disease: an update of a systematic review. Respir Med. 2008 Dec;102(12):1715-29. Epub 2008 Aug 15. 11. Ries AL, Make BJ, Reilly JJ. Pulmonary rehabilitation in emphysema. Proc Am Thorac Soc. 2008;5(4):524-529. 12. Nici L. Preoperative and postoperative pulmonary rehabilitation in lung cancer patients. Thorac Surg Clin. 2008;18(1):39-43. 13. CMS. Centers for Medicare & Medicaid Services. NCD for Pulmonary Rehabilitation Services (240.8). Effective 9/25/07. Implementation date 1/7/2008. References Initial 1. Heppner PS, Morgan C, Kaplan RM, Ries AL. Regular walking and long-term maintenance of outcomes after pulmonary rehabilitation. J Cardiopulm Rehabil. 2006 Jan-Feb;26(1):44-53. 2. Abramson MJ, Crockett AJ, Frith PA, McDonald CF. COPDX: an update of guidelines for the management of chronic obstructive pulmonary disease with a review of recent evidence. Med J Aust. 2006 Apr 3;184(7):342-5. 3. Pleasants RA, Haden D. An update on chronic obstructive pulmonary disease. Consult Pharm. 2005 Nov;20(11):965-75. 4. Pierson DJ. Clinical practice guidelines for chronic obstructive pulmonary disease: a review and comparison of current resources. Respir Care. 2006 Mar;51(3):277-88. 5. Hill NS. Pulmonary rehabilitation. Proc Am Thorac Soc. 2006;3(1):66-74. 6. Garrod R, Marshall J, Barley E, Jones PW. Predictors of success and failure in pulmonary rehabilitation. Eur Respir J. 2006 Apr;27(4):788-94. Epub 2006 Feb 15. 7. Maltais F, Bourbeau J, Lacasse Y, et al. A Canadian, multicentre, randomized clinical trial of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease: Rationale and methods. Can Respir J. 2005;12(4):193-198. 8. National Institute for Clinical Excellence (NICE). Chronic obstructive pulmonary disease: Management of chronic obstructive pulmonary disease in adults in primary and secondary care. London, UK: NICE; 2004. 9. Bateman ED, Feldman C, O'Brien J, et al. Guideline for the management of chronic obstructive pulmonary disease (COPD): 2004 revision. S Afr Med J. 2004;94(7 Pt 2):559-575. Pulmonary Rehabilitation May 15 20

10. Salman GF, Mosier MC, Beasley BW, Calkins DR. Rehabilitation for patients with chronic obstructive pulmonary disease: Meta-analysis of randomized controlled trials. J Gen Intern Med. 2003;18(3):213-221. 11. Ram FSF, Robinson SM, Black PN. Physical training for asthma (Cochrane Review). In: The Cochrane Library, Issue 4, 2003. Chichester, UK: John Wiley & Sons, Ltd 12. Bradley J, Moran F, Greenstone M. Physical training for bronchiectasis (Cochrane Review). In: The Cochrane Library, Issue 4, 2003. Chichester, UK: John Wiley & Sons, Ltd. 13. Medical Technology Unit-Federal Social Insurance Office Switzerland (MTU- FSIOS). Effectiveness of rehabilitation in chronic obstructive pulmonary disease. Bern, Switzerland: MTU-FSIOS; 2003. 14. Fishman, A., Martinez, F., et al: A randomized trial comparing lung volumereduction surgery with medical therapy for severe emphysema. N Engl J Med 348:2059-73, 2003 15. O'Donnell DE, Aaron S, Bourbeau J, et al. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease-- 2003. Can Respir J. 2003;10 Suppl A:11A-65A. 16. Sin DD, McAlister FA, Man SF, Anthonisen NR. Contemporary management of chronic obstructive pulmonary disease: Scientific review. JAMA. 2003;290(17):2301-2312. 17. Abdulwadud O. Outpatient multidisciplinary pulmonary rehabilitation program for patients with chronic respiratory conditions. Clayton, Victoria, Australia: Centre for Clinical Effectiveness (CCE); 2002. 18. Petty TL. COPD in perspective. Chest. 2002;121(5 Suppl):116S-120S. 19. Lacasse Y, Brosseau L, Milne S, et al. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2002;(3):CD003793. 20. McDermott A. Pulmonary rehabilitation for patients with COPD. Prof Nurse. 2002;17(9):553-556. 21. Dyer CA, White R. Pulmonary rehabilitation -- the evidence base. Gerontology. 2001;47(5):231-235. 22. Ferguson GT. Recommendations for the management of COPD. Chest. 2000;117(2 Suppl):23S-28S. 23. San Pedro GS. Pulmonary rehabilitation for the patient with severe chronic obstructive pulmonary disease. Am J Med Sci. 1999;318(2):99-102. 24. Owens MW, Markewitz BA, Payne DK. Outpatient management of chronic obstructive pulmonary disease. Am J Med Sci. 1999;318(2):79-83. 25. Cambach W, Wagenaar RC, Koelman TW, et al. The long-term effects of pulmonary rehabilitation in patients with asthma and chronic obstructive pulmonary disease: A research synthesis. Archiv Phys Med Rehab. 1999;80(1):103-111. 26. McBride A, Milne R. Hospital-based pulmonary rehabilitation programmes for patients with severe chronic obstructive pulmonary disease. Southampton, UK: Wessex Institute for Health Research and Development; 1999. 27. ZuWallack RL. Selection criteria and outcome assessment in pulmonary rehabilitation. Monaldi Arch Chest Dis. 1998;53(4):429-437. 28. Resnikoff PM, Ries AL. Pulmonary rehabilitation for chronic lung disease. J Heart Lung Transplant. 1998;17(7):643-650. 29. Folgering H, Rooyackers J. Pulmonary rehabilitation in chronic obstructive pulmonary disease. Eur Respir J. 1998;11(3):520-523. Pulmonary Rehabilitation May 15 21

30. Crouch R, MacIntyre NR. Pulmonary rehabilitation of the patient with nonobstructive lung disease. Respir Care Clin N Am. 1998;4(1):59-70. 31. Mahler DA. Pulmonary rehabilitation. Chest. 1998;113(4 Suppl):263S-268S. 32. Tiep BL. Disease management of COPD with pulmonary rehabilitation. Chest. 1997;112(6):1630-1656. 33. Ketelaars CA, Abu-Saad HH, Schlosser MA, et al. Long-term outcome of pulmonary rehabilitation in patients with COPD. Chest. 1997;112(2):363-369. 34. Sridhar MK. Pulmonary rehabilitation. BMJ. 1997;314(7091):1361-1362. 35. Ries AL, Kaplan RM, Limberg TM, et al. Effects of pulmonary rehabilitation on physiologic and psychosocial outcomes in patients with chronic obstructive pulmonary disease. Ann Intern Med. 1995;(122):823-832. 36. Wijkstra PJ, Van Altena R, Kraan J, et al. Quality of life in patients with chronic obstructive pulmonary disease improves after rehabilitation at home. Eur Respir J. 1995;(7):269-273. 37. American Association of Cardiovascular and Pulmonary Rehabilitation: Outcome measurement in cardiac and pulmonary rehabilitation. J Cardiopulmonary Rehabil 15:39 1995 Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. Pulmonary Rehabilitation May 15 22

No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code 1367.63 requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code 1367.6 requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Pulmonary Rehabilitation May 15 23