Medical Policies - Therapy
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A single course of pulmonary rehabilitation in the outpatient ambulatory care setting may be considered medically necessary for outpatient treatment of chronic pulmonary disease for patients with moderate to severe disease who are experiencing disabling symptoms and significantly diminished quality of life in spite of optimal medical management.
A single course of pulmonary rehabilitation may be considered medically necessary in an outpatient ambulatory care setting as a preoperative conditioning component for those considered appropriate candidates for lung volume reduction surgery or for lung transplantation.
NOTE: Pulmonary rehabilitation is typically provided for 4-6 hours per week for up to 12 weeks.
Pulmonary rehabilitation programs may be considered medically necessary following lung transplantation.
Pulmonary rehabilitation programs are considered experimental, investigational and/or unproven in all other indications including but not limited to programs following other types of lung surgery (e.g., lung volume reduction surgery and surgical resection of lung cancer).
Multiple courses of pulmonary rehabilitation are considered not medically necessary:
• As maintenance therapy in patients who initially respond, or
• In patients who fail to respond or whose response to an initial rehabilitation program has diminished over time.
Home-based pulmonary rehabilitation programs are considered experimental, investigational and/or unproven.
Pulmonary rehabilitation programs are considered experimental, investigational and/or unproven in all other situations.
Pulmonary rehabilitation (PR) is a multidisciplinary approach to reducing symptoms and improving quality of life in patients with compromised lung function. PR programs generally include a patient assessment followed by therapeutic interventions including exercise training, education, and behavior change.
In 2013, the American Thoracic Society (ATS) and the European Respiratory Society (ERS) have defined pulmonary rehabilitation (PR) 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.” (1) PR programs are intended to improve patient functioning and quality of life. Most research has focused on patients with chronic obstructive pulmonary disease (COPD), although there has been some interest in patients with asthma, cystic fibrosis, or bronchiectasis.
PR is also routinely offered to patients awaiting lung transplantation and lung volume reduction surgery. PR before lung surgery may stabilize or improve patients’ exercise tolerance, teach patients techniques that will help them recover after the procedure, and allow health care providers to identify individuals who might be suboptimal surgical candidates due to noncompliance, poor health, or other reasons.
A pulmonary rehabilitation outpatient program is a comprehensive program that generally includes team assessment, patient training, psychosocial intervention, exercise training, and follow-up. The overall length of the program and the total number of visits for each component may vary from program to program.
• Team assessment includes input from a physician, respiratory care practitioner, nurse, and psychologist, among others.
• Patient training includes breathing retraining, bronchial hygiene, medications, and proper nutrition.
• Psychosocial intervention addresses support system and dependency issues.
• Exercise training includes strengthening and conditioning and may include 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 component of pulmonary rehabilitation. Education in disease management techniques without exercise conditioning does not improve health outcomes of patients who have chronic obstructive pulmonary disease.
• Follow-up to a comprehensive outpatient pulmonary rehabilitation program may include supervised home exercise conditioning.
Candidates for pulmonary rehabilitation should be medically stable and not limited by another serious or unstable medical condition. Contraindications to pulmonary rehabilitation include severe psychiatric disturbance (e.g., dementia, organic brain syndrome), and significant or unstable medical conditions (e.g., heart failure, acute cor pulmonale, substance abuse, significant liver dysfunction, metastatic cancer, disabling stroke).
The original policy was based on a Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment. (2) The policy was updated regularly with searches of the MEDLINE database. The following is a summary of the literature to date.
The focus of this policy will be on comprehensive, multidisciplinary programs that include an exercise component plus other modalities. Where there is a lack of evidence on multidisciplinary pulmonary rehabilitation (PR) programs, interventions that are strictly exercise will be considered. In this regard, exercise constitutes the primary intervention that improves outcomes and that if exercise alone improves outcomes, then it would be expected that exercise plus other modalities will improve outcomes to the same degree or greater.
Chronic Obstructive Pulmonary Disease
Numerous randomized controlled trials (RCTs) and several systematic reviews of RCTs have been published. Most recently, a 2016 Cochrane review by Puhan et al. evaluated PR programs for patients who had an exacerbation of chronic obstructive pulmonary disease (COPD). (3) To be included, the rehabilitation program had to begin within 3 weeks of initiating exacerbation treatment and had to include physical exercise. Twenty trials (total N=1477 participants) met inclusion criteria. Rehabilitation was outpatient in 6 trials, inpatient in 12 trials, both inpatient and outpatient in 1 trial, and home-based in 1 trial. In a pooled analysis of 8 trials, there was a statistically significant reduction in the primary outcome (rate of hospital admissions) for PR compared with usual care (odds ratio [OR], 0.44; 95% confidence interval [CI], 0.21 to 0.91). Several secondary outcomes also favored the PR group. In a pooled analysis of 13 trials, there was a significantly greater improvement from baseline in the 6-minute walk distance (6MWD) in the PR groups (mean difference [MD], 62.4 meters; 95% CI, 38.5 to 86.3 meters). Moreover, a poled analysis of health-related quality of life (HRQOL) found significantly greater improvement after PR versus control (MD = -7.80; 95% CI, -12.1 to -3.5). However, in a pooled analysis of 6 trials, there was no statistically significant difference between groups in mortality rate (OR=0.68; 95% CI, 0.28 to 1.67). Trials had a mean duration of only 12 months which may not be long enough to ascertain a difference in mortality rates.
A 2015 Cochrane review by McCarthy et al. included RCTs assessing the effect of outpatient or inpatient PR on functional outcomes and/or disease-specific quality of life (QOL) in patients with COPD. (4) PR programs had to be at least 4 weeks in duration and include exercise therapy with or without education and/or psychological support. Sixty-five RCTs (total N=3822 participants) met inclusion criteria. COPD severity was not specifically addressed by Cochrane reviewers, but article titles suggest a focus on patients with moderate-to-severe COPD. In pooled analyses, there was statistically significantly greater improvement in all outcomes in PR groups than in usual care groups. In addition, between-group differences on key outcomes were clinically significant. For example, on all 4 important domains of the validated Chronic Respiratory Questionnaire (CRQ) - dyspnea, fatigue, emotional function, and mastery - the effect was larger than the accepted minimal clinically important difference (MCID) of 0.5 units.
In addition, the between-group difference in maximal exercise capacity exceeded the MCID of 4 watts and the between-group difference in 6MWD - a mean difference of 43.93 meters - was considered clinically significant.
A 2015 systematic review by Rugbjerg et al. identified 4 RCTs (total N=489 participants). (5) Inspection of the trial designs for the 4 RCTs indicated that none actually evaluated a comprehensive PR program in patients who met criteria for mild COPD. Rather than being comprehensive PR programs, all interventions were exercise-based. One intervention included an educational component and another used a qigong intervention, which included breathing and meditation in addition to exercise. In addition, none of the RCTs enrolled a patient population with only mild COPD. Roman et al. (2013) (6) and Gottlieb et al. (2011) (7) included patients with moderate COPD, Liu et al. (2012) (8) included patients with mild-to-moderate COPD, and van Wetering et al. (2010) (9) included patients with moderate-to-severe COPD. Conclusions cannot be drawn about the efficacy of PR in patients with mild COPD from this systematic review.
Section Summary: Chronic Obstructive Pulmonary Disease
Multiple RCTs and meta-analyses of RCTs have, for the most part, found improved outcomes (i.e., functional ability, QOL) in patients with moderate-to-severe COPD who have had a comprehensive PR program in the outpatient setting. There is limited evidence on the efficacy of repeated and/or prolonged PR programs, and that evidence is mixed on whether these programs improve additional health outcome benefits.
Idiopathic Pulmonary Fibrosis
A small 2014 pilot RCT by Jackson et al. evaluated patients with idiopathic pulmonary fibrosis (IPF) who were 40 to 80 years of age and had disease onset between 3 and 48 months before screening, abnormal pulmonary function, and a 6MWD between 150 and 500 meters. (10) Patients were assigned to a PR program consisting of twice-weekly 2-hour rehabilitation sessions over 12 weeks (n=14) or usual care (n=11). Twenty-one of the 25 patients completed the 3-month intervention study. Reviewers did not report between-group statistics. Follow-up data at 3 months postintervention were reported by Gaunaurd et al. (2014). (11) During the intervention, patients in the PR group had significantly greater self-reported physical activity, but, in the subsequent 3 months, activity levels in the 2 groups were similar. For example, at 6 months, pulmonary function measures (e.g., total lung capacity, forced vital capacity [FVC], spirometry diffusion capacity) did not change significantly within either group. 6MWD was not reported.
Section Summary: Idiopathic Pulmonary Fibrosis
One small RCT has evaluated a comprehensive PR program in patients with IPF; at 3 months postintervention, outcomes did not differ between groups that did and did not receive PR.
In 2016, Lee et al. published a systematic review of RCTs on PR in patients with non-cystic fibrosis bronchiectasis. (12) Reviewers identified 4 RCTs. They selected studies of exercise-only interventions as well as exercise combined with education and/or another intervention. The control intervention had to be something other than exercise-based. A pooled analysis of 3 RCTs immediately after an 8-week intervention found significantly greater incremental shuttle walk distance (ISWD) in the intervention compared with the control group (MD=66.6; 95% CI, 51.8 to 81.7). A pooled analysis of 2 trials found significantly greater improvement in the St. George's Respiratory Questionnaire (SGRQ) score postintervention (MD = -4.65; 95% CI, -6.70 to -2.60). There was no significant difference postintervention on the Leicester Cough Questionnaire (total) scores. Reviewers did not conduct meta-analyses of data beyond the immediate postintervention period.
Section Summary: Bronchiectasis
A systematic review of RCTs on PR for patients with bronchiectasis found that some, but not all, outcomes improved more with PR than with a nonexercise control condition immediately postintervention. Limited observational data suggest that outcomes in patients with other respiratory conditions may benefit, but likely not as much as COPD patients.
PR Programs Before Lung Surgery
Lung Volume Reduction Surgery
PR prior to lung volume reduction surgery (LVRS) represents a distinct subset of patients with COPD, and the National Emphysema Treatment Trial (NETT) requires all candidates to undergo a vigorous course of PR. The final NETT results supported the treatment effectiveness in a subset of patients with COPD. (13)
A systematic review of literature on PR for lung transplant candidates was published by Hoffman et al. in 2017. (14) Interventions had to include exercise training but did not have to be part of a comprehensive PR program and could have taken place in the inpatient or outpatient setting. Reviewers identified 6 studies - 2 RCTs and 4 case series. Both RCTs evaluated the impact of exercise (not comprehensive PR) on outcomes; additionally, 1 was conducted in the inpatient setting and included only 9 patients. Conclusions on the impact of a comprehensive PR program prior to lung transplantation on health outcomes cannot be drawn from this systematic review.
Lung Cancer Resection
Several small RCTs have evaluated preoperative PR for patients undergoing lung cancer resection. In 2013, Morano et al. conducted a single-blind study in Brazil. (15) Patients with non-small-cell lung cancer (NSCLC) eligible for lung resection were randomized to 4 weeks of an exercise-only PR program (5 sessions per week) or to chest physical therapy; there were 12 patients in each group. All patients in the PR group and 9 of 12 in the chest physical therapy group subsequently underwent surgery (the other 3 patients had inoperable disease). Several short-term postoperative outcomes were assessed. Patients in the PR group spent significantly fewer days in the hospital (mean, 7.8 days) than patients in the chest physical therapy group (mean, 12.2 days; p=0.04). In addition, patients in the PR group spent fewer days with chest tubes (mean, 4.5 days) than the physical therapy group (mean, 7.4 days; p=0.03). The trial did not assess longer term functional outcomes after surgery.
In 2011, Benzo et al. conducted 2 small exploratory RCTs evaluating PR before lung cancer resection. (16) Eligibility criteria included having moderate-to-severe COPD and being scheduled for lung cancer resection either by open thoracotomy or by video-assisted thoracoscopy. The first trial had poor recruitment, enrolling only 9 patients. The second study enrolled 19 patients into a 10-session, preoperative PR program (n=10) or usual care (n=9). Mean number of days in the hospital was 6.3 in the PR group and 11.0 in the control group (p=0.058). Three (33%) patients in the PR group and 5 (63%) patients in the control group experienced postoperative pulmonary complications (p=0.23). The trial sample size was likely too small to detect statistically or clinically significant differences between groups. Trialists recommended conducting a larger multicenter randomized trial in this population.
In 2013, a nonrandomized comparative study evaluated an outpatient-based PR intervention in 58 lung cancer patients who were candidates for surgery. (17) This United Kingdom (U.K.) study by Bradley et al. also evaluated a comparison group of 305 patients, also surgical candidates, who received usual care. Patients in the 2 groups were matched by age, lung function, comorbidities, and type of surgery. In a within-group analysis, there was a statistically significant 20-meter improvement in 6MWD in the intervention group before and after participation in a 4-session presurgical PR program. In between-group analyses, there were not statistically significant differences between the intervention and comparisons groups in clinical outcomes such as postoperative pulmonary complications, readmissions, and mortality after surgery.
Section Summary: PR Programs Before Lung Surgery
There is a lack of large RCTs comparing PR with no PR for preoperative candidates undergoing LVRS, lung transplantation, or lung cancer resection. Moreover, the available studies evaluated exercise programs, but not necessarily comprehensive PR. In addition, the few small RCTs and observational studies have reported short-term outcomes and have found inconsistent evidence of benefit even on these outcomes. However, NETT did require PR before LVRS, which is the standard of care before LVRS and lung transplantation.
PR Programs After Lung Surgery
Lung Volume Reduction Surgery
No RCTs evaluating comprehensive PR programs after LVRS were identified. A 2009 case series by Bering et al. reported on 49 patients with severe emphysema who participated in a PR program after LVRS. (18) Patients underwent LVRS at a single center and had not received PR at that institution presurgery. After hospital discharge, patients underwent an outpatient comprehensive PR program for 4 hours a day, 5 days a week for 2 weeks. The program included a multidisciplinary team including with a variety of components, including dietary, physical therapy, physical exercise, psychosocial, occupational therapy, and respiratory therapy. The primary outcome was HRQOL measured by the 36-Item Short-Form Health Survey. Compared with pre-LVRS scores, significantly better scores were achieved on the Physical Component Summary and Mental Component Summary at both time 2 (3-6 months post-LVRS) and time 3 (12-18 months LVRS). Study limitations included no comparison with patients who had LVRS and no PR and the difficulty disentangling the impact of LVRS from that of PR on outcomes. Moreover, patients had not received PR before LVRS, so the treatment effects of pre-versus postsurgery LVRS could not be determined.
Section Summary: PR Programs After LVRS
No comparative studies have evaluated PR programs after LVRS. One case series has evaluated a comprehensive PR program after LVRS in 49 patients who had not received preoperative PR. HRQOL was higher at 3 to 6 months and 12 to 18 months postsurgery. The study did not provide data on patients who underwent LVRS and did not have postoperative PR or on patients who had preoperative PR.
No RCTs evaluating comprehensive PR programs after lung transplantation were identified. A 2009 case series, published by Munro et al., evaluated a comprehensive PR program after lung surgery. (19) The 7-week program, which started 1 month postsurgery, consisted of 1 hour of supervised exercise 3 times a week and a weekly group education session facilitated by a multidisciplinary team (e.g., nurse, dietician, occupational therapist, social worker). Compared with baseline, on program completion, both forced expiratory volume in 1 second (FEV1) and FVC had improved significantly (p<0.001). For example, mean FEV1 was 71% 1 month postsurgery and 81% at 3 months. Similarly, 6MWD improved significantly: mean distance was 451 meters at 1 month and 543 meters at 3 months posttransplant. The study lacked a control group, hence, the degree of improvement that would have occurred without participation in a PR program is unknown.
There is literature on exercise training after lung transplantation (not necessarily provided in comprehensive PR programs). In 2010, Wickerson et al. published a systematic review of RCTs and nonrandomized studies that have evaluated any type of exercise intervention in lung transplantation. (20) Seven studies met inclusion criteria; 2 were RCTs, 2 were uncontrolled trials, and 1 used healthy controls. Reviewers did not pool study findings. The 2 RCTs evaluated lumbar extension training and its impact on lumbar bone mineral density; neither reported functional outcomes. The uncontrolled studies reported improvements in functional status following exercise interventions.
In 2012, an RCT conducted in the U.K. by Langer et al. examined activity-related outcomes in lung transplant recipients after exercise training. (21) The trial included 40 patients who underwent single-or double-lung transplantation and had an uncomplicated postoperative period. Following hospital discharge, patients were randomized to a supervised exercise program 3 times a week for 3 months (n=21) or to usual care with instructions to exercise (n=19). Patients in both groups had 6 individual counselling sessions in the 6 months postdischarge. Six patients dropped out of the trial, 3 in each group. The primary outcome was daily walking time, assessed by activity monitors. At the end of the 3-month intervention and at 1-year postdischarge, mean walking time was significantly longer in the intervention group. At 1 year, the exercise group walked a mean of 85 minutes per day while the control group walked a mean of 54 minutes per day (p=0.006). Other outcomes related to daily physical activity were reported as secondary outcomes and some, but not all, significantly favored the intervention group. Mean 6MWD at 1 year was 86% of predicted in the exercise group and 74% of predicted in the control group (p=0.002). The trial had a relatively small sample size and may have been underpowered to detect clinically meaningful differences between groups on secondary outcomes.
Section Summary: PR Programs After Lung Transplantation
A systematic review of exercise training after lung transplantation (not necessarily provided in a comprehensive PR program) identified 7 controlled and uncontrolled studies but did not pool study findings. Neither of the RCTs identified reported functional outcomes but the uncontrolled studies did report improvements in functional outcomes. An RCT, published after the systematic review, found that patients who had a postsurgical exercise intervention walked more 1-year postdischarge and had a significantly greater 6MWD. Findings on other outcomes were mixed. Case series data also support improvement in the 6MWD after postoperative PR.
Lung Cancer Resection
One 2013 RCT, by Stigt et al., has evaluated a multicomponent postsurgery PR program in patients with resectable lung cancer. (22) The trial was conducted in the Netherlands. Before thoracotomy, 57 patients were randomized to PR or usual care. The 12-week PR program started 4 weeks after surgery and consisted of exercise training, pain management, and visits with a medical social worker. The trial was terminated early because the institution started offering video-assisted thoracoscopic surgery, at which point few patients chose thoracotomy. Data on 49 patients (PR=23, usual care=26) were analyzed. The primary end point was QOL, as measured by the difference between groups in change in the total SGRQ score from baseline to 12 months. This difference was 2.71 points, which was not statistically significant (p=0.69). However, 6MWD (a secondary outcome) improved significantly more in the PR group than in the usual care group at 3 months. The between-group difference in 6MWD was 94 meters (p=0.024). A limitation of this analysis is that only 8 of 23 patients in the PR performed a 6MWD at 3 months; the other 15 patients had dropped out or did not take the test. Eleven of 25 patients in the usual care group performed the 6MWD test.
An exercise-only intervention after lung cancer surgery (not comprehensive PR) was evaluated in an RCT published by Edvardsen et al. in 2015. (23) This single-blind trial was conducted in Norway and included lung cancer patients at 4 to 6 weeks postsurgery. Sixty-one patients were randomized to an exercise program 3 times a week for 20 weeks or to usual care. The exercise intervention took place at local fitness centers and was supervised by trained personal trainers and physical therapists. Significantly greater improvement was reported for the primary outcome (change in peak oxygen uptake from baseline to the end of the intervention) in the intervention group than in the control group (between-group difference, 0.26 L/min; p=0.005.) Findings on secondary outcomes were mixed. For example, the between-group difference in FEV1 was 0.6% predicted (95% CI, -4.2% to 5.4%; p=0.738) and the difference in stair run was 4.3 steps (95% CI, 1.6 to 7.1 steps; p=0.002). This trial did not report other functional outcomes (e.g., 6MWD).
Repeat and Maintenance PR Programs
Both repeat and maintenance PR programs provide additional rehabilitation services after initial participation in a PR program. Program categories are not strictly defined but repeat programs are generally those that include patients who failed to respond to an initial program or whose response to an initial rehabilitation program diminished over time. In contrast, maintenance programs tend to be those designed to extend the effects of the initial PR program, and they are open to all patients who successfully completed an initial program.
Repeat PR Program
One RCT was identified that evaluated a repeat PR program. Carr et al. (2009) prospectively identified Canadian patients with moderate-to-severe COPD who experienced an acute exacerbation within 12 months of participating in a PR program. (24) Initially, patients completed a 6-week inpatient program or a 12-week outpatient program. The repeat PR program lasted 3 weeks and consisted of exercise and education; patients could choose inpatient or outpatient versions. Over 6 months, 41 patients developed an exacerbation and 12 did not. Seven patients withdrew from the trial, and the remaining 34 were randomized to a repeat PR program within 1 month of the exacerbation (n=17) or to no repeat PR program (n=17). One patient in the intervention group dropped out; of the remaining 33 patients, 25 (76%) experienced an exacerbation of moderate severity; the remaining 8 had severe exacerbations. Nine (56%) of 16 patients in the intervention group chose an inpatient program and 7 chose an outpatient program. Patients were assessed before the repeat PR program, immediately after (3 weeks later), and again 12 weeks after the beginning of the exacerbation (≈ 5 weeks after completing the repeat rehabilitation program). The primary outcome was change in HRQOL, as measured on the 4 domains of the CRQ score. There was no statistically significant difference between groups in mean change in CRQ scores. Among patients in the intervention group, the magnitude of improvement in the domains of dyspnea (0.7 points) and fatigue (0.5 points) met or exceeded the MCID. In the control group, the magnitude of change in all domains did not meet the MCID. Change in the 6MWD (a secondary outcome) did not differ significantly between groups at either follow-up. Outcomes were not reported separately for the inpatient or outpatient programs (this medical policy addresses outpatient programs). Trialists recommended that future evaluations of repeat PR programs include patients with more serious exacerbations, last longer than 3 weeks, and start as close in time as possible to the exacerbation. Conclusions about repeat PR programs cannot be drawn from 1 study with 33 subjects.
Maintenance PR Program
In 2012, an Ontario Health Technology Assessment evaluated PR for patients with COPD. (25) Reviewers identified 3 RCTs (total N=284 participants) assessing maintenance PR programs for individuals with COPD who had successfully completed an initial PR program. The trials excluded patients who had experienced a recent acute exacerbation of COPD. All maintenance programs consisted of supervised exercise sessions; program duration was 3 months in 1 program and 12 months in the other 2 programs. One program also included an unsupervised exercise component, and 1 included educational sessions. Reviewers judged study quality as generally poor, due to methodologic limitations (e.g., inadequate information on randomization, allocation concealment, blinding, and lack of clarity around the use of an intention-to-treat analysis). In a pooled analysis of data from 2 trials (n=168 patients), there was a significantly greater improvement in 6MWD in patients who participated in the maintenance program than in those in a control group (MD=22.9 meters; 95% CI, 5.2 to 40.7 meters). The confidence interval was wide, indicating lack of precision in the pooled estimate. In addition, reviewers considered the MCID to be 25 to 35 meters walked, and meta-analysis of trial findings did not meet this threshold of difference between groups.
Several RCTs were published after the Ontario assessment. In 2017, Guell et al. published findings of a 3-year trial of patients with severe COPD. (26) A total of 143 patients attended an initial 8-week outpatient PR program and 138 were then randomized to a 3-year maintenance program (n=68) or to a control group (n=70). The maintenance intervention consisted of home-based exercises, calls from a physical therapist every 2 weeks, and supervised training sessions every 2 weeks. The control group was advised to exercise at home without supervision. Some outcomes but not others favored the intervention group at 2 years, but outcomes did not differ significantly between groups at 3 years. For example, compared with baseline, at 2 years the 6MWD increased by 2 meters in the intervention group and decreased by 32 meters in the control group (p=0.046). At 3 years, compared with baseline, the 6MWD decreased by 4 meters in the intervention group and decreased by 33 meters in the control group (p=0.119). The CRQ dyspnea score, at 2 years compared with baseline, decreased by 0.4 points in the intervention group and by 0.3 points in the control group (p=0.617); findings were similar at 3 years. The trial also had a high dropout rate.
In 2015, Wilson et al. published a single-blind RCT comparing maintenance PR to standard care without maintenance PR in patients with COPD who had completed at least 60% of an initial PR program. (27) One hundred forty-eight patients were randomized; 110 (74%) completed the trial and were included in the analysis. The maintenance program consisted of a 2-hour session every 3 months for 1 year. The session included an hour of education and an hour of supervised individualized exercise training. The primary efficacy outcome was change from baseline (post-PR) in the CRQ dyspnea domain. Among trial completers, mean CRQ dyspnea score changed from 2.6 to 3.2 among patients receiving maintenance PR and from 2.5 to 3.3 among controls. The difference between groups was not statistically significant. Secondary outcomes, including other CRQ domains, scores on the endurance shuttle walk test (ESWT), and number of exacerbations or hospitalizations, also did not differ significantly between groups.
Section Summary: Repeat and Maintenance PR Programs
A few small RCTs have been performed that evaluate repeat or maintenance rehabilitation programs. Due to the paucity of RCTs, methodologic limitations of available trials, and lack of clinically significant findings, the evidence to determine the effect of repeat and maintenance PR programs on health outcomes in patients with COPD is insufficient.
Home-Based PR Programs
Evaluation of home-based PR programs involves searching for evidence that these programs are at least as effective as programs conducted in the ambulatory care setting. The programs also need to be comprehensive and be feasible in the U.S. health care system.
Several RCTs and systematic reviews of RCTs have assessed home-based PR programs. Among the systematic reviews, Liu et al. (2014) identified 18 RCTs evaluating home-based PR programs. (28) Most trials compared PR with usual care, and none of the selected trials compared home-based with clinic-based programs. Only 2 trials were conducted in the United States, and both were published in the 1990s. All trials reported different outcomes over different timeframes, and pooled analyses only included data from 2 to 4 studies. For example, a pooled analysis of 3 studies (n=112 patients) reporting the SGRQ total score found statistically significant improvements in symptoms with home-based PR compared with control (effect size, -11.33; 95% CI, -16.37 to -6.29). A pooled analysis of data from 4 studies (n=167 patients) found a significantly increased 6MWD after 12 weeks in the PR group compared with control (effect size, 35.9; 95% CI, 9.4 to 62.4). The latter analysis had a wide confidence interval, indicating that estimate of effect was imprecise.
Previously, a 2010 systematic review by Vieira et al. identified 12 RCTs comparing home-based PR to PR in another setting or to standard care in patients with COPD. (29) The comparison intervention in 3 trials was a hospital-based program; in 8 trials, it was standard care; and in 1 trial, both comparisons were made. The methodologic quality of the trials was considered average to poor, and most had small sample sizes and relatively short follow-up durations. Reviewers did not pool trial findings, and findings of individual studies were mixed. Three trials that compared home-based PR with standard care reported on between-group differences in QOL; in all 3 studies, differences were reported as statistically significant. The 2 trials that reported differences in exercise capacity found home-based PR to result in significantly greater improvements in the 6MWD or constant work rate test than standard care. On the other hand, in the 3 trials comparing home-based PR and hospital-based programs, there were no statistically significant differences between groups in QOL changes. Moreover, in the 2 trials that assessed maximal work level and the 2 trials that assessed the 6MWD, outcomes did not differ significantly after home-based or hospital-based PR programs. Reviewers commented that their analysis was limited by the generally low quality of the randomized trials and short-term length of follow-up.
Another systematic review was published by Neves et al. in 2016. (30) However, this review combined home and community-based PR programs in analyses so no conclusions can be drawn on the impact of home-based programs compared with programs based in the ambulatory care setting.
A study with a relatively large sample size and that compared home-based PR with outpatient clinic- based PR was published by Maltais et al. in 2008. (31) This noninferiority trial was conducted in Canada. Eligibility criteria included stable COPD for at least 4 weeks before study participation and no previous participation in PR programs; 252 patients were included. All patients initially completed a 4-week self-management educational program. They were then randomized to receive 8 weeks of self-monitored home-based exercise training or to outpatient hospital-based exercise training. The exercise program included aerobic and strength exercises conducted 3 times a week. Patients were followed for 40 weeks after completion of the exercise program. Both interventions produced similar improvements in the CRQ dyspnea domain scores at 1 year - improvement in dyspnea of 0.62 (95% CI, 0.43 to 0.80) units in the home intervention (n=107) and 0.46 (95% CI, 0.28 to 0.64) units in the outpatient intervention (n=109). The difference between treatments at 1 year was considered clinically unimportant. The trial did not evaluate a comprehensive PR program.
Section Summary: Home-Based PR Program
Most studies of home-based PR have compared it to standard care. Very few studies have compared home-based PR with hospital or clinic-based PR, and those available are mostly of low quality. Therefore, there is insufficient evidence to determine whether comprehensive PR programs conducted in the home setting are at least as effective as comprehensive PR programs in the ambulatory care setting.
Summary of Evidence
Chronic Pulmonary Disease Rehabilitation
For individuals with moderate-to-severe chronic obstructive pulmonary disease (COPD) who receive a single course of outpatient pulmonary rehabilitation (PR), the evidence includes numerous randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, functional outcomes, and quality of life. The published studies found improved outcomes (i.e., functional ability, quality of life) in patients with moderate-to-severe COPD who underwent a comprehensive PR program in the outpatient setting. Among the many randomized trials, the structure of the PR programs varies, so it is not possible to provide guidance on the optimal components or duration of a PR program. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.
For individuals with idiopathic pulmonary fibrosis (IPF) who receive a single course of outpatient PR, the evidence includes a RCT. Relevant outcomes are symptoms, functional outcomes, and quality of life. The number of controlled studies is limited. One small RCT evaluated a comprehensive PR program in patients with IPF; at 3 months postintervention, outcomes did not differ between groups who did and did not receive PR. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals with bronchiectasis who receive a single course of outpatient PR, the evidence includes RCTs, systematic reviews, and observational data. Relevant outcomes are symptoms, functional outcomes, and quality of life. A systematic review of 4 RCTs on PR for patients with bronchiectasis found that some, but not all, outcomes, improved more with PR than with nonexercise control conditions immediately after the intervention. The evidence is insufficient to determine the effects of the technology on health outcomes.
Preparation for Lung Surgery
For individuals with scheduled lung surgery for volume reduction, transplantation, or resection who receive a single course of outpatient PR, the evidence includes RCTs and observational studies. Relevant outcomes are symptoms, functional outcomes, and quality of life. There is a lack of large RCTs comparing PR with no PR for preoperative candidates undergoing lung volume reduction surgery (LVRS), lung transplantation, or lung cancer resection. Moreover, the available studies have evaluated exercise programs, but not necessarily comprehensive PR programs. In addition, the few small RCTs and observational studies have reported short-term outcomes and inconsistent evidence of benefit even on these outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes. However, NETT did require PR before LVRS, which is the standard of care before LVRS and lung transplantation.
PR Programs After Lung Surgery
For individuals who have had LVRS who receive a single course of outpatient PR, the evidence includes a case series. Relevant outcomes are symptoms, functional outcomes, and quality of life. No published RCTs were identified. The case series evaluated a comprehensive PR program after LVRS in 49 patients who had not received preoperative PR. Health-related quality of life was higher at 3 to 6 months and at 12 to 18 months postsurgery. The series did not provide data on patients who underwent LVRS and did not have postoperative PR, or patients who had preoperative PR. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have had lung transplantation who receive a single course of outpatient PR, the evidence includes RCTs, systematic reviews, and observational studies. Relevant outcomes are symptoms, functional outcomes, and quality of life. Neither of the 2 RCTs identified in a 2010 systematic review reported functional outcomes, but uncontrolled studies have reported improvements in functional outcomes. A RCT, published after the systematic review, found that patients who had a postsurgical exercise intervention walked more 1 year postdischarge than before and had a significantly greater 6- minute walk distance (6MWD). Findings on other outcomes were mixed. Case series data also support improvements in 6MWD after postoperative PR. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.
For individuals who have had lung cancer resection who receive a single course of outpatient PR, the evidence includes 1 RCT. Relevant outcomes are symptoms, functional outcomes, and quality of life. One small RCT have evaluated a comprehensive PR program in patients who underwent thoracotomy for lung cancer. The trial was terminated early, had a high dropout rate, and reported mixed findings. An exercise-only intervention in patients who had lung cancer surgery had mixed findings and did not evaluate functional outcomes. The evidence is insufficient to determine the effects of the technology on health outcome.
Repeat or Maintenance Rehabilitation
For individuals who have had an initial course of PR who receive repeat or maintenance outpatient PR, the evidence includes RCTs. Relevant outcomes are symptoms, functional outcomes, and quality of life. There are only a few RCTs and many of them have methodologic limitations and/or did not report clinically significant outcomes. The evidence is insufficient to determine the effects of the technology on health outcome.
For individuals who have an indication for outpatient PR who receive a single course of home-based PR, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, and quality of life. Most studies of home-based PR have compared outcomes with standard care. Very few have compared home-based PR with hospital- or clinic-based PR, and the available studies are mostly of low quality. The evidence is insufficient to determine the effects of the technology on health outcome.
Practice Guidelines and Position Statements
American Thoracic Society and European Respiratory Society
A 2013 joint statement on pulmonary rehabilitation (PR) was issued by the American Thoracic Society (ATS) and the European Respiratory Society (ERS). (1) The statement included the following relevant conclusions:
• “PR provided to patients with respiratory disease other than COPD [chronic obstructive pulmonary disease]… has demonstrated improvement in respiratory symptoms, exercise tolerance and quality of life”.
• “Symptomatic individuals with COPD who have lesser degrees of airflow limitation who participate in rehabilitation derive similar improvements in symptoms, exercise tolerance and quality of life as do those with more severe disease.”
• “Appropriately resourced home-based exercise training has proven effective at reducing dyspnea and increasing exercise performance in patients with COPD.”
British Thoracic Society
The 2013 guidelines on PR in adults by the British Thoracic Society included the following recommendations (32):
• “Pulmonary rehabilitation should be offered to patients with chronic obstructive pulmonary disease (COPD) with a view to improving exercise capacity,” “dyspnea and health status,” and “psychological wellbeing.”
• “Pulmonary rehabilitation programmes of 6-12 weeks are recommended”
• “[A] minimum of 12 supervised sessions are recommended, although individual patients can gain benefit from fewer sessions.”
• “If considering a structured home-based rehabilitation programme, the following factors need careful consideration: mechanisms to offer remote support and/or supervision, provision of home exercise equipment and patient selection.”
American College of Physicians et al.
Joint guidelines on management of COPD were issued in 2011 by the American College of Physicians, the American College of Chest Physicians (ACCP), ATS, and ERS. (33) The guidelines recommended that: “clinicians should prescribe pulmonary rehabilitation for symptomatic patients with an FEV [forced expiratory volume] <50% predicted (Grade: strong recommendation, moderate-quality evidence). Clinicians may consider pulmonary rehabilitation for symptomatic or exercise-limited patients with an FEV >50% predicted (Grade: weak recommendation, moderate-quality evidence).”
American College of Chest Physicians et al.
In 2007, joint guidelines on PR for COPD and other chronic respiratory diseases were issued by ACCP and the American Association of Cardiovascular and Pulmonary Rehabilitation. (34) A number of recommendations, including the following, were based on strong (1A) or moderate (1B) evidence (see Table 2).
Table 2. ACCP and AACPR Pulmonary Rehabilitation Guidelines for Chronic Respiratory Diseases
A program of exercise training of the muscles of ambulation is recommended as a mandatory component of pulmonary rehabilitation for patients with COPD
Pulmonary rehabilitation improves the symptom of dyspnea and improves health-related quality of life in patients with COPD
Six to 12 weeks of pulmonary rehabilitation produces benefits in several outcomes that decline gradually over 12 to 18 months
Both low- and high-intensity exercise training produce clinical benefits for patients with COPD
Unsupported endurance training of the upper extremities is beneficial in patients with COPD and should be included in pulmonary rehabilitation programs
Higher-intensity exercise training of the lower extremities produces greater physiologic benefits than lower-intensity training in patients with COPD
Evidence does not support the routine use of inspiratory muscle training as an essential component of pulmonary rehabilitation
Education should be an integral component of pulmonary rehabilitation; it should include information on collaborative self-management and prevention and treatment of exacerbations
Pulmonary rehabilitation is beneficial for some patients with chronic respiratory diseases other than COPD
AACPR: American Association of Cardiovascular and Pulmonary Rehabilitation; ACCP: American College of Chest Physicians; COPD: chronic obstructive pulmonary disease.
Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.
While there are global HCPCS codes for pulmonary rehabilitation services such as G0237-G0239, G0302-G0305, G0424 and S9473, the component services may be reported separately using CPT codes such as 97110 and 97530, or an unlisted code such as 94799 or 97799 may be reported.
Disclaimer for coding information on Medical Policies
Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.
Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.
The following codes may be applicable to this Medical policy and may not be all inclusive.
G0237, G0238, G0239, G0302, G0303, G0304, G0305, G0424, S9473
ICD-9 Diagnosis Codes
Refer to the ICD-9-CM manual
ICD-9 Procedure Codes
Refer to the ICD-9-CM manual
ICD-10 Diagnosis Codes
Refer to the ICD-10-CM manual
ICD-10 Procedure Codes
Refer to the ICD-10-CM manual
The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.
The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.
A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
1. Spruit MA, Singh SJ, Garvey 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. Oct 15 2013; 188(8):e13-64. PMID 24127811
2. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Pulmonary rehabilitation for patients with chronic obstructive pulmonary disease. TEC Assessments. 1996; Volume 11:Tab 4.
3. Puhan MA, Gimeno-Santos E, Cates CJ, et al. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. Dec 08 2016; 12:CD005305. PMID 27930803
4. McCarthy B, Casey D, Devane D, et al. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015; 2:CD003793. PMID 25705944
5. Rugbjerg M, Iepsen UW, Jorgensen KJ, et al. Effectiveness of pulmonary rehabilitation in COPD with mild symptoms: a systematic review with meta-analyses. Int J Chron Obstruct Pulmon Dis. 2015; 10:791-801. PMID 25945044
6. Roman M, Larraz C, Gomez A, et al. Efficacy of pulmonary rehabilitation in patients with moderate chronic obstructive pulmonary disease: a randomized controlled trial. BMC Fam Pract. 2013; 14:21. PMID 23399113
7. Gottlieb V, Lyngso AM, Nybo B, et al. Pulmonary rehabilitation for moderate COPD (GOLD 2) --does it have an effect? COPD. Oct 2011; 8(5):380-386. PMID 21936683
8. Liu X-D, Jin H-Z, Ng B-P, et al. Therapeutic effects of gigong in patients with COPD: a randomized controlled trial. Hong Kong J Occup Ther. 2012; 22(1):38-46.
9. van Wetering CR, Hoogendoorn M, Mol SJ, et al. Short- and long-term efficacy of a community-based COPD management programme in less advanced COPD: a randomised controlled trial. Thorax. Jan 2010; 65(1):7-13. PMID 19703824
10. Jackson RM, Gomez-Marin OW, Ramos CF, et al. Exercise limitation in IPF patients: a randomized trial of pulmonary rehabilitation. Lung. Jun 2014; 192(3):367-376. PMID 24705678
11. Gaunaurd IA, Gomez-Marin OW, Ramos CF, et al. Physical activity and quality of life improvements of patients with idiopathic pulmonary fibrosis completing a pulmonary rehabilitation program. Respir Care. Dec 2014; 59(12):1872-1879. PMID 25185149
12. Lee AL, Hill CJ, McDonald CF, et al. Pulmonary rehabilitation in individuals with non-cystic fibrosis bronchiectasis: a systematic review. Arch Phys Med Rehabil. Jun 16 2016. PMID 27320420
13. Fishman A, Martinez F, Naunheim K, et al. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med. May 22 2003; 348(21):2059-2073. PMID 12759479
14. Hoffman M, Chaves G, Ribeiro-Samora GA, et al. Effects of pulmonary rehabilitation in lung transplant candidates: a systematic review. BMJ Open. Feb 03 2017; 7(2):e013445. PMID 28159852
15. Morano MT, Araujo AS, Nascimento FB, et al. Preoperative pulmonary rehabilitation versus chest physical therapy in patients undergoing lung cancer resection: a pilot randomized controlled trial. Arch Phys Med Rehabil. Jan 2013; 94(1):53-58. PMID 22926460
16. Benzo R, Wigle D, Novotny P, et al. Preoperative pulmonary rehabilitation before lung cancer resection: results from two randomized studies. Lung Cancer. Dec 2011; 74(3):441-445. PMID 21663994
17. Bradley A, Marshall A, Stonehewer L, et al. Pulmonary rehabilitation programme for patients undergoing curative lung cancer surgery. Eur J Cardiothorac Surg. Oct 2013; 44(4):e266-271. PMID 23959742
18. Beling J. Improved health-related quality of life after lung volume reduction surgery and pulmonary rehabilitation. Cardiopulm Phys Ther J. Sep 2009; 20(3):16-22. PMID 20467519
19. Munro PE, Holland AE, Bailey M, et al. Pulmonary rehabilitation following lung transplantation. Transplant Proc. Jan-Feb 2009; 41(1):292-295. PMID 19249538
20. Wickerson L, Mathur S, Brooks D. Exercise training after lung transplantation: a systematic review. J Heart Lung Transplant. May 2010; 29(5):497-503. PMID 20133160
21. Langer D, Burtin C, Schepers L, et al. Exercise training after lung transplantation improves participation in daily activity: a randomized controlled trial. Am J Transplant. Jun 2012; 12(6):1584-1592. PMID 22390625
22. 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. Feb 2013; 8(2):214-221. PMID 23238118
23. Edvardsen E, Skjonsberg OH, Holme I, et al. High-intensity training following lung cancer surgery: a randomised controlled trial. Thorax. Mar 2015; 70(3):244-250. PMID 25323620
24. Carr SJ, Hill K, Brooks D, et al. Pulmonary rehabilitation after acute exacerbation of chronic obstructive pulmonary disease in patients who previously completed a pulmonary rehabilitation program. J Cardiopulm Rehabil Prev. Sep-Oct 2009; 29(5):318-324. PMID 19561523
25. Health Quality Ontario. Ontario Health Technology Series: Pulmonary rehabilitation for patients with chronic pulmonary disease (COPD): An evidence-based analysis. 2012; Available at <http://www.hqontario.ca> (accessed February 16, 2017).
26. Guell MR, Cejudo P, Ortega F, et al. Benefits of long-term pulmonary rehabilitation maintenance program in patients with severe chronic obstructive pulmonary disease. three-year follow-up. Am J Respir Crit Care Med. Mar 01 2017; 195(5):622-629. PMID 27611807
27. 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; 5(3):e005921. PMID 25762226
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29. Vieira DS, Maltais F, Bourbeau J. Home-based pulmonary rehabilitation in chronic obstructive pulmonary disease patients. Curr Opin Pulm Med. Mar 2010;16(2):134-143. PMID 20104176
30. Neves LF, Reis MH, Goncalves TR. Home or community-based pulmonary rehabilitation for individuals with chronic obstructive pulmonary disease: a systematic review and meta-analysis. Cad Saude Publica. Jun 20 2016; 32(6). PMID 27333130
31. Maltais F, Bourbeau J, Shapiro S, et al. Effects of home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. Dec 16 2008; 149(12):869-878. PMID 19075206
32. Bolton CE, Bevan-Smith EF, Blakey JD, et al. British Thoracic Society guideline on pulmonary rehabilitation in adults. Thorax. Sep 2013; 68 Suppl 2:ii1-30. PMID 23880483
33. Qaseem A, Wilt TJ, Weinberger SE, et al. 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. Aug 2 2011; 155(3):179-191. PMID 21810710
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35. Outpatient Pulmonary Rehabilitation. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2017 March) Therapy 8.03.05.
36. Garvey C. Reimbursement for Pulmonary Rehabilitation (2014). Available at < http://www.thoracic.org> (accessed on May 25, 2017).
|6/15/2018||Reviewed. No changes.|
|7/15/2017||Document updated with literature review. Coverage unchanged.|
|7/15/2016||Reviewed. No changes.|
|7/1/2015||Document updated with literature review. The following statements were added to the coverage section: 1) Pulmonary rehabilitation programs may be considered medically necessary following lung transplantation. 2) The following was added to the experimental, investigational and/or unproven statement pulmonary rehabilitation programs are considered experimental, investigational and/or unproven for all other indications including but not limited to programs following other types of lung surgery (e.g., lung volume reduction surgery and surgical resection of lung cancer).|
|9/1/2014||Document updated with literature review. The following was added to coverage: Pulmonary rehabilitation programs are considered experimental, investigational and/or unproven in all other situations. A NOTE was added to the coverage section: Pulmonary Rehabilitation is typically provided for 4-6 hours per week for up to 12 wks. The following coverage change was made: Multiple courses of pulmonary rehabilitation are considered not medically necessary.|
|2/1/2014||Document updated with literature review. Coverage changed to include Home-based pulmonary rehabilitation programs are considered experimental, investigational and unproven.|
|12/15/2010||Document updated with literature review. Coverage changed to include conditional coverage of pulmonary rehabilitation for lung transplantation. Description revised, rationale replaced. CPT/HCPCS code(s) updated.|
|1/1/2006||New Medical Document|
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