| Coverage Policy Manual | |
| Policy #: | 1998114 |
| Category: | Rehabilitation |
| Initiated: | February 1998 |
| Last Review: | April 2023 |
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| Pulmonary Rehabilitation | |
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| Description: |
Pulmonary rehabilitation is a multidisciplinary approach to reducing symptoms and improving quality of life in patients with compromised lung function. Pulmonary rehabilitation programs generally include a patient assessment followed by therapeutic interventions including exercise training, education, and behavior change.
In 2013, the American Thoracic Society and the European Respiratory Society defined pulmonary rehabilitation as a “comprehensive intervention based on a thorough patient assessment followed by patient-tailored therapies that include, but are not limited to exercise training, education, and behavior change” (Spruit, 2013). Pulmonary rehabilitation programs are intended to improve patient functioning and quality of life. Most research has focused on patients with chronic obstructive pulmonary disease, although there has been some interest in patients with asthma, cystic fibrosis, or bronchiectasis.
Pulmonary rehabilitation is also routinely offered to patients awaiting lung transplantation and lung volume reduction surgery. Pulmonary rehabilitation 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.
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Policy/ Coverage: |
Effective February 2019
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Pulmonary rehabilitation in the outpatient treatment of chronic obstructive pulmonary disease (COPD), for patients with moderate to moderately severe disease who are symptomatic despite optimal medical management meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. The patient must not smoke currently and must have been a non-smoker (including, but not limited to cigarettes, e-cigarettes and illicit drugs) for at least six months prior to participating in the rehabilitation program.
Pulmonary rehabilitation in the outpatient treatment setting related to lung transplant meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is limited to 36 sessions per lifetime.
This service will be paid at global price, that includes pulmonary function tests, physical therapy maneuvers, occupational therapy maneuvers, chest x-rays, CT scans, etc. The following is a list of CPT codes that are included in the global price and which would not be covered separately:
36600, 36620, 71010, 71020, 71260, 78460, 78461, 78472, 78473, 78481, 78483, 78596, all codes in the 80000 series, 93000, 93005, 93010, 93720, 93721, 93722, 94002-94005, 94010, 94060, 94070, 94150, 94200, 94250, 94260, 94350, 94360, 94370, 94375, 94400, 94450, 94620, 94642, 94660, 94662, 94664, 94667, 94668, 94680, 94681, 94690, 94720, 94725, 94750, 94760, 94761, 94762, 94770, 95070, 95071, 95805-95811, 95831, 95834, 95851, 96101, 96102, 96103, 96105, 96116, 96118, 96119, 96120, 97001, 97002, 97003, 97004, 97110, 97113, 97116, 97124, 97150, 97530, 97535, 97537, 97542, 97545.
The American Association of Cardiovascular and Pulmonary Rehabilitation has defined five essential components of pulmonary rehabilitation:
The monitoring of the patient with ear oximetry and/or electrocardiography during the muscle and exercise training would be considered part of the global.
The patient would be expected to be trained in exercises that the patient could perform at home, as the present information on pulmonary rehabilitation indicates that the rehabilitation benefit is lost within a short time after cessation of exercise training.
Only one rehab will be allowed per lifetime.
Any facility that wishes to do pulmonary rehab should supply their selection criteria before payment is allowed.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Pulmonary rehabilitation for any indication other than COPD or lung transplant does not meet primary coverage criteria and is not covered. Published guidelines of national and/or international workgroups of medical experts, widely used medical compendia, or technology assessments published by independent technology assessment organizations have classified non-covered uses as investigational or as questionable or of unknown benefit.
For contracts without primary coverage criteria pulmonary rehabilitation for any reason other than COPD or lung transplant is considered investigational and is not covered. Investigational services are an exclusion in the member benefit certificate.
Effective Prior to February 2019
Pulmonary rehabilitation is considered medically necessary in the outpatient treatment of chronic obstructive pulmonary disease (COPD), for patients with moderate to moderately severe disease who are symptomatic despite optimal medical management. The patient must not smoke currently and must have been a non-smoker (including, but not limited to cigarettes, e-cigarettes and illicit drugs) for at least six months prior to participating in the rehabilitation program.
This service will be paid at global price, that includes pulmonary function tests, physical therapy maneuvers, occupational therapy maneuvers, chest x-rays, CT scans, etc. The following is a list of CPT codes that are included in the global price and which would not be covered separately:
36600, 36620, 71010, 71020, 71260, 78460, 78461, 78472, 78473, 78481, 78483, 78596, all codes in the 80000 series, 93000, 93005, 93010, 93720, 93721, 93722, 94002-94005, 94010, 94060, 94070, 94150, 94200, 94250, 94260, 94350, 94360, 94370, 94375, 94400, 94450, 94620, 94642, 94660, 94662, 94664, 94667, 94668, 94680, 94681, 94690, 94720, 94725, 94750, 94760, 94761, 94762, 94770, 95070, 95071, 95805-95811, 95831, 95834, 95851, 96101, 96102, 96103, 96105, 96116, 96118, 96119, 96120, 97001, 97002, 97003, 97004, 97110, 97113, 97116, 97124, 97150, 97530, 97535, 97537, 97542, 97545.
The American Association of Cardiovascular and Pulmonary Rehabilitation has defined five essential components of pulmonary rehabilitation:
The monitoring of the patient with ear oximetry and/or electrocardiography during the muscle and exercise training would be considered part of the global.
The patient would be expected to be trained in exercises that the patient could perform at home, as the present information on pulmonary rehabilitation indicates that the rehabilitation benefit is lost within a short time after cessation of exercise training.
Only one rehab will be allowed per lifetime.
Any facility that wishes to do pulmonary rehab should supply their selection criteria before payment is allowed.
Pulmonary rehabilitation for any indication other than COPD does not meet primary coverage criteria and is not covered. Published guidelines of national and/or international workgroups of medical experts, widely used medical compendia, or technology assessments published by independent technology assessment organizations have classified non-covered uses as investigational or as questionable or of unknown benefit.
For contracts without primary coverage criteria pulmonary rehabilitation for any reason other than COPD is considered investigational and is not covered. Investigational services are an exclusion in the member benefit certificate.
Effective Prior to April 2018
Pulmonary rehabilitation is considered medically necessary in the outpatient treatment of chronic
obstructive pulmonary disease (COPD), for patients with moderate to moderately severe disease who
are symptomatic despite optimal medical management. The patient must not smoke currently and
must have been a non-smoker for at least six months prior to participating in the rehabilitation
program.
This service will be paid at global price, that includes pulmonary function tests, physical therapy
maneuvers, occupational therapy maneuvers, chest x-rays, CT scans, etc. The following is a list of
CPT codes that are included in the global price and which would not be covered separately:
36600, 36620, 71010, 71020, 71260, 78460, 78461, 78472, 78473, 78481, 78483, 78596, all codes in
the 80000 series, 93000, 93005, 93010, 93720, 93721, 93722, 94002-94005, 94010, 94060, 94070,
94150, 94200, 94250, 94260, 94350, 94360, 94370, 94375, 94400, 94450, 94620, 94642, 94660,
94662, 94664, 94667, 94668, 94680, 94681, 94690, 94720, 94725, 94750, 94760, 94761, 94762,
94770, 95070, 95071, 95805-95811, 95831, 95834, 95851, 96101, 96102, 96103, 96105, 96116,
96118, 96119, 96120, 97001, 97002, 97003, 97004, 97110, 97113, 97116, 97124, 97150, 97530,
97535, 97537, 97542, 97545.
The American Association of Cardiovascular and Pulmonary Rehabilitation has defined five essential
components of pulmonary rehabilitation:
The monitoring of the patient with ear oximetry and/or electrocardiography during the muscle and
exercise training would be considered part of the global.
The patient would be expected to be trained in exercises that the patient could perform at home, as the present information on pulmonary rehabilitation indicates that the rehabilitation benefit is lost
within a short time after cessation of exercise training.
Only one rehab will be allowed per lifetime.
Any facility that wishes to do pulmonary rehab should supply their selection criteria before payment is
allowed.
Pulmonary rehabilitation for any indication other than COPD does not meet primary coverage criteria
and is not covered. Published guidelines of national and/or international workgroups of medical experts, widely used medical compendia, or technology assessments published by independent technology assessment organizations have classified non-covered uses as investigational or as questionable or of unknown benefit.
For contracts without primary coverage criteria pulmonary rehabilitation for any reason other than
COPD is considered investigational and is not covered. Investigational services are an exclusion in
the member benefit certificate.
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| Rationale: |
2002 Update
A search of the MEDLINE database was performed for the period of 1996 to April 2002. The search strategy focused on randomized controlled trials and practice guidelines for pulmonary rehabilitation. In 1997, the American College of Chest Physicians (ACCP) and the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) jointly issued evidence based guidelines regarding pulmonary rehabilitation. The panel considered the various components of pulmonary rehabilitation and assigned a letter grade designating the overall strength of the scientific evidence for each recommendation. The following scale was used:
A: Scientific evidence provided by well-designed, well-conducted, controlled trials with statistically significant results that consistently support the guideline recommendation.
B: Scientific evidence provided by observational studies or by controlled trials with less consistent results to support the guideline recommendation
C: Expert opinion that supports the guideline recommendation because the available scientific evidence did not present consistent results or because controlled trials were lacking.
The guidelines made the following recommendations:
Lower extremity training: A
Lower extremity training improves exercise tolerance and is recommended as part of pulmonary rehabilitation
Upper extremity training: B
Strength and endurance training improves arm function; arm exercises should be included in pulmonary rehabilitation
Ventilatory muscle training: B
Scientific evidence does not support the routine use of VMT in pulmonary rehabilitation; it may be considered in selected patients with decreased respiratory muscle strength and breathlessness
Psychosocial, behavioral, and educational components and outcomes: C
Evidence does not support the benefits of short-term psychosocial interventions as single therapeutic modalities; longer-term interventions may be beneficial; expert opinion supports inclusion of educational and psychosocial intervention components in pulmonary rehabilitation
Dyspnea: A
Pulmonary rehabilitation improves the symptom of dyspnea
Quality of life: C
Pulmonary rehabilitation improves health-related QOL
Health-care utilization: B
Pulmonary rehabilitation has reduced the number of hospitalizations and days of hospitalization
Survival: C
Pulmonary rehabilitation may improve survival
These guidelines did not make a separate distinction for different indications for pulmonary rehabilitation, i.e., for patients with asthma, cystic fibrosis, or conditions other than COPD. The document makes the following observation: “The majority of literature regarding rehabilitative exercise deals with one variety of lung disease – COPD. The relatively sparse literature regarding the effectiveness of non-COPD exercise programs leaves open the possibility that direct extrapolation of approaches used in COPD to these other lung disorders may not be appropriate.”
These guidelines also do not address other important aspects of pulmonary rehabilitation, such as: the duration and intensity of the program (i.e., how many total visits, how many times per week, etc.), place of service (i.e., clinic- based, community-based or home-based), specific patient selection criteria (i.e., moderate to severe COPD), and the value of a repeat course of rehabilitation, either 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.
The literature search spanning 1996 to April 2002 identified multiple randomized trials examining various different aspects of pulmonary rehabilitation. In general, these trials support the conclusions of the ACCP/AACVPR guidelines, i.e., pulmonary rehabilitation is associated with a decrease in dyspnea and an improvement in quality of life in patients with COPD. However, all the programs differed, both in the individual components of the program and its duration. For example, the programs ranged in length from 6 weeks to 6 months. A review of a representative sample of these trials is provided below. Of interest is that all the randomized studies were conducted outside the United States, and thus conclusions regarding the structure of a pulmonary rehabilitation program may not be applicable to the United States health care system.
Guell and colleagues reported on the results of a study that randomized 60 patients with COPD to undergo pulmonary rehabilitation (PR) or standard care. The specific focus of the study was to examine the long-term effects (24 months) of the PR program. The patients received breathing retraining in the first 3 months followed by exercise training in the next 3 months. The improvement in both symptoms and quality of life noted 3 months after completion of the program continued with somewhat diminished magnitude in the second year of follow-up. Griffiths and colleagues focused on the use of health services over 1 year in a group of 200 patients with COPD who were randomized to a PR program or standard medical management. The days spent in the hospital were substantially lower in the PR group compared to the control group. The PR group also showed greater improvement in walking ability and disease specific health status, which declined with time, similar to the Guell study. The study by Cambach and colleagues included 43 patients with asthma and 69 patients with COPD who were randomized to a 3-month crossover trial of PR or standard care. The PR program was community based in that it was delivered by community physiotherapists as opposed to multidisciplinary rehabilitation centers. Similar improvements were noted among both those with asthma and COPD, although the conclusions of the study are somewhat limited by the large number of dropouts (i.e., 23 of 112). Wedzicha and colleagues examined the effects of a PR program in patients with moderately severe and severe COPD who were randomized to receive a 8-week program of PR or standard care. Patients with severe COPD were treated at home. While there was a significant improvement in exercise performance and quality of life among those with moderately severe COPD assigned to the PR program, there was no improvement in those with severe COPD.
2008 Update
A MEDLINE database search was performed for October 2002 through December 2007. The paper on Pulmonary Rehabilitation: Joint ACCP/AACVPR Evidence-Based Clinical Practice Guidelines, published in Chest, 2007: 131:4-42 is primarily related to the evidence for pulmonary rehabilitation in COPD. At the end of these guidelines the authors write, “Although most of the studies conducted and published to date investigating the outcomes of pulmonary rehabilitation for disorders other than COPD are uncontrolled trials or case series, RCTs are beginning to emerge…Further research is needed to identify optimal training regimens, program structures, and outcome measurement tools that are useful in pulmonary rehabilitation for patients with respiratory disorders other than COPD.”
The Cochrane Database of Systematic Reviews 2006, Issue 4, includes a meta-analysis of pulmonary rehabilitation for patients with COPD, but there is no analysis of rehabilitation for other lung diseases because most of the studies published at this time are uncontrolled trials or case series.
The Agency for Healthcare Research and Quality had the Tufts-New England Medical Center Evidence-Based Practice Center do an analysis of effectiveness of pulmonary rehabilitation which was published in November 2006.
“This technology assessment is based on a systemic review of the scientific literature and focuses on randomized controlled trials (RCT) or meta-analyses thereof…Briefly, the technology assessment summarizes the available evidence on the efficacy and safety of PR interventions, and describes the influence of patient-level or study-level characteristics….
“Overall this technology assessment is based on a re-analysis of 44 RCT included in three published systematic reviews, and 26 additional RCT that had not been assessed by these reviews. There is little evidence on the effects of PR in diseases other than COPD. The two eligible trials in non COPD population yielded results similar to that obtained from the COPD trials.”
“There is little evidence available on the efficacy and safety of PR on diseases other than COPD. In fact, only two trials on other diseases (a trial on idiopathic bronchiectasis and a trial on patients with a variety of diagnoses who were weaning from mechanical ventilation) were eligible according to the inclusion criteria we employed. Their results were similar to the findings of trials on COPD patients. There is also very limited evidence on safety outcomes…”
2012 Update
There is no additional scientific literature identified that would prompt a change in the coverage statement.
2014 Update
A literature search conducted through June 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
A 2013 systematic review by Jacome et al searched for studies on PR in patients with mild COPD (Jacombe, 2013). They identified only one RCT, which was determined to be insufficient evidence to support PR programs in this population.
A 2013 trial by Roman et al in Spain randomized 97 patients to 1 of 3 groups: PR for 3 months followed by 12 months of rehabilitation maintenance, PR for 3 months only, and usual care (Roman, 2013). Participants had moderate COPD according to GOLD criteria. The PR program was conducted in an ambulatory care setting and included education, respiratory physiotherapy and muscle training. The prespecified primary outcome was change in the Spanish validated version of the Chronic Respiratory Questionnaire (CRQ) at 3 and 12 months. A change of 0.5 points per item was considered to represent a clinically significant change in the score. At 12 months, there was not a statistically significant difference between groups in any of the 4 dimensions of the CRQ (ie, dyspnea, fatigue, emotional function, or mastery). At 3 months, the only statistically significant difference was between the PR only and control group on the dyspnea dimension and this favored the control group. There were no statistically significant differences between groups on secondary outcomes including the 6-minute walk test (6MWT) and forced expiratory volume in 1 second (FEV1).
Several RCTs and systematic reviews of RCTs have been published on home-based PR programs. Among the systematic reviews, Liu et al in 2013 identified 18 RCTs evaluating home-based PR programs (Liu, 2013). Most studies compared PR to usual care and none of the included trials compared home-based and clinic-based programs. Only 2 of the 18 studies were conducted in the U.S. and both of those were published in the 1990s. The studies reported different outcomes over different timeframes, and pooled analysis only included data from 2 to 4 studies. For example, a pooled analysis of 3 studies with a total of 112 patients reporting the SGRQ total score found statistically significant improvement in symptoms with home-based PR compared to control (effect size, -11.33; 95% CI, -16.37 to -6.29). A pooled analysis of data from 4 studies (N=167) found a significantly increased 6MWD after 12 weeks in the PR group compared to control (effect size, 35.9; 95% CI, 9.4 to 62.4). The latter analysis had a wide CI, indicating that there is not a precise estimate of effect size.
In 2011, Benzo et al published findings of 2 small exploratory RCTs evaluating PR prior to lung cancer resection (Benzo, 2011). Eligibility criteria included having moderate to severe COPD and being scheduled for lung cancer resection either by open thoracotomy or video-assisted thoracoscopy. The first study had poor recruitment and was only able to enroll 9 patients. The second study enrolled 19 patients in either a 10-session preoperative PR program (n=10) or usual care (n=9).
The mean (SD) number of days in the hospital was 6.3 (3.0) in the PR group and 11.0 (6.3) in the control group (p=0.058). A total of 3 patients (33%) in the PR group and 5 patients (63%) in the control group experienced postoperative pulmonary complications (p=0.23). The study likely had too small a sample size to detect statistically and clinically significant differences between groups. The authors recommended that a larger multicenter randomized trial be conducted in this population of patients. In 2013, a non-RCT on PR for patients undergoing lung cancer surgery was identified. The study, by Bradley and colleagues in the U.K., evaluated an outpatient-based PR intervention in 58 lung cancer patients who were candidates for surgery (Bradley, 2013). The investigators also evaluated a comparison group of 305 patients, also surgical candidates, who received usual care. Patients in the 2 groups were matched for age, lung function, comorbidities, and type of surgery. In a within-group analysis, there was a statistically significant improvement in the 6MWT of 20 meters 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 following surgery.
Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (HomeBase) (NCT01423227): This study, conducted in Australia, is randomizing 144 patients with COPD to a hospital-based PR program or a home-based PR program. The primary outcome is change in 6MWD at 8 weeks and at 12 months. The expected completion date is October 2014.
The literature supports the conclusion that a comprehensive pulmonary rehabilitation (PR) program in the outpatient ambulatory care setting in patients with moderate to severe chronic respiratory disease is associated with improved symptoms and quality of life. Although there have been many randomized trials, the structure of PR programs is variable, so it is not possible to provide further guidance regarding the optimal components of a PR program or its duration. There are insufficient data to conclude whether a comprehensive home-based PR program is at least as effective at improving the net health outcome compared to PR provided in the ambulatory care setting. Thus, a single course of PR may be considered medically necessary in the ambulatory care setting for patients with moderate to severe chronic pulmonary disease who meet criteria and investigational in the home setting. There are insufficient data focusing on programs designed to maintain the benefits of a PR program or evaluate repeat PR programs. Thus, repeat and maintenance PR programs are considered investigational.
For patients undergoing lung surgery, findings from the National Emphysema Treatment Trial suggest a subset of chronic obstructive pulmonary disease (COPD) patients who are appropriate candidates for PR prior to lung volume reduction surgery. For patients undergoing lung transplantation, PR is considered standard of care to maximize preoperative pulmonary status. For patients undergoing lung cancer resection, there are a few small RCTs but these trials have not demonstrated a consistent benefit of PR on health outcomes. Therefore a single course of PR in an outpatient setting is considered medically necessary for patients prior to lung resection surgery or lung transplantation.
Practice Guidelines and Position Statements
A 2013 guideline on PR in adults by the British Thoracic Society includes the following recommendations (Bolton, 2013):
2017 Update
A literature search conducted through January 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Patients With Chronic Obstructive Pulmonary Disease
Numerous randomized controlled trials (RCTs) and several systematic reviews of RCTs have been published. A 2015 Cochrane review by McCarthy and colleagues included RCTs on the effect of outpatient or inpatient PR on functional and/or disease-specific quality of life (QOL) outcomes in patients with chronic obstructive pulmonary disease (COPD) (McCarthy, 2015). PR programs had to be at least 4 weeks in duration and include exercise therapy with our without education and/or psychological support. Sixty-five RCTs (total N=3822 participants) met inclusion criteria. COPD severity was not specifically addressed by the Cochrane authors, but article titles reflect a focus on patients with moderate-to-severe COPD. In the pooled analyses, there was statistically significantly greater improvement in all outcomes in the 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 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 the 6-minute walk distance (6MWD), a mean difference (MD) of 43.93 meters, was considered clinically significant.
A 2015 systematic review by Rugbjerg and colleagues identified 4 RCTs (total N=489 participants) (Rugbjerg, 2015). Inspection of the study designs in the 4 RCTs indicates 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 includes breathing and meditation in addition to exercise.
In 2015, Wilson and colleagues 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 (Wilson, 2015). One hundred forty-eight patients were randomized; 110 (74%) completed the study 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 dyspnea domain of the CRQ. Among study completers, the mean (SD) CRQ dyspnea score changed from 2.6 (1.0) to 3.2 (1.1) among patients receiving maintenance PR and from 2.5 (1.2) to 3.3 (1.3) among controls. The difference between groups was not statistically significant. Secondary outcomes, including other domains of the CRQ, scores on the endurance shuttle walk test (ESWT), and number of exacerbations or hospitalizations, also did not differ significantly between groups.
2018 Update
A literature search conducted using the MEDLINE database through January 2018 did not reveal any new literature that would prompt a change in the coverage statement. The key identified literature is summarized below.
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) (Puhan, 2016). 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.
Section Summary: Chronic Obstructive Pulmonary Disease
Multiple RCTs and meta-analyses of RCTs have, for the most part, found improved outcomes (ie, 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.
BRONCHIECTASIS
In 2016, Lee et al published a systematic review of RCTs on PR in patients with non-cystic fibrosis bronchiectasis (Lee, 2016). 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 post-intervention (MD = -4.65; 95% CI, -6.70 to -2.60). There was no significant difference post-intervention 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 post-intervention. 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 Transplantation
A systematic review of literature on PR for lung transplant candidates was published by Hoffman et al in 2017 (Hoffman, 2017). 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 of the RCTs evaluated the impact of exercise (not comprehensive PR) on outcomes; additionally, 1 was conducted in the inpatient setting and the 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.
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 (Beling, 2009). 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.
Maintenance PR Program
In 2017, Guell et al published findings of a 3-year trial of patients with severe COPD (Guell, 2017). 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.
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 maintenance PR programs on health outcomes in patients with COPD is insufficient.
2019 Update
A literature search was conducted through March 2019. There was no new information identified that would prompt a change in the coverage statement.
2020 Update
A literature search was conducted through March 2020. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
The meta-analysis by Yu et al evaluated pulmonary rehabilitation for exercise tolerance and quality of life for patients with idiopathic pulmonary fibrosis (Yu, 2019). They analyzed results of 5 RCTs (N=190 participants). In addition to better 6-minute walk distance and Saint George's Respiratory Questionnaire results with pulmonary rehabilitation than with standard treatment, forced vital capacity was significantly higher for the pulmonary rehabilitation group (MD=3.69; 95% CI, 0.16 to 7.23; p=.04). However, pulmonary rehabilitation had no significant effect on lung diffusing capacity determined by the single-breath technique (MD=3.02; 95% CI, -0.38 to 6.42; p=.08). The results of this study suggest the benefits of pulmonary rehabilitation lie in its effect on quality of life, and it may slow the decline of lung function in patients with idiopathic pulmonary fibrosis. Cheng et al looked at 4 RCTs and evaluated results in terms of short-term (9-12 weeks) and long-term (6-12 months) outcomes (Cheng, 2018). They found significant benefits in the short term as measured by 6 minute walk distance and Saint George's Respiratory Questionnaire, but the benefits did not last in the long term.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A Cochrane review by Downman et al evaluated the efficacy and safety of pulmonary rehabilitation in patients with interstitial lung disease in terms of short-term (≤6 months) and long-term outcomes (6-11 months); a priori subgroup analyses were performed for participants with idiopathic pulmonary fibrosis (Dowman, 2021).,In patients with idiopathic pulmonary fibrosis, there were significant improvements in 6MWD and Saint George's Respiratory Questionnaire results with pulmonary rehabilitation versus standard treatment in the short-term, but the benefits did not last in the long term. Additionally, pulmonary rehabilitation improved dyspnea scores based on the modified Medical Research Dyspnea Scale (0–4 point scale; 0 indicates no dyspnea) in studies with a follow-up duration of 8 to 12 weeks (MD=-0.41; 95% CI, -0.74 to 0.09). Long-term survival was not improved with pulmonary rehabilitation versus standard treatment in studies with a follow-up of 6 to 11 months (OR=0.32; 95% CI, 0.08 to 1.19).
In 2021, the ATS published a report from a workshop that was convened to achieve consensus on the essential components of pulmonary rehabilitation and to identify requirements for successful implementation of emerging program models (Holland, 2021). A Delphi process involving experts from across the world identified 13 "essential" components of pulmonary rehabilitation that must be delivered in any program model, encompassing patient assessment, program content, method of delivery, and quality assurance; an additional 27 "desirable" components were also identified. See the full text of this publication for further details.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Araújo et al conducted an RCT in Brazil on the effects of pulmonary rehabilitation in individuals with bronchiectasis (Araujo, 2022). Adults with bronchiectasis confirmed with high-resolution computer tomography were randomized to receive outpatient pulmonary rehabilitation (3 weekly sessions; n=20) or a control intervention consisting of usual care, airway clearance therapy, and breathing exercises (n=21) for 3 months. Physical capacity (measured by 6MWD), dyspnea, quality of life (measured by the Saint George's Respiratory Questionnaire), fatigue, respiratory muscle strength, and fibrinogen levels were measured before and after treatment. At the end of the 3 month period, the 6MWD increased by a mean of 54 meters in the rehabilitation group versus 12 meters in the control group (p<.01). Additionally, fibrinogen showed a significant reduction in the rehabilitation group compared to control (-92.8 vs. -47.1 mg/dl; p<.01) at 3 months from baseline; quality of life improved at a greater magnitude in the rehabilitation group (-7.5 vs. 3.2; p<.01), which exceeded the minimal clinically important difference of 4 points. This study was limited by its small sample size and short follow-up period.
Stafinski et al identified 12 RCTs and 2 comparative observational studies (N=2293) to include in their systematic review evaluating home-based pulmonary rehabilitation programs in individuals with COPD (Stafinski, 2022). Nine studies compared home-based pulmonary rehabilitation to usual care, 4 compared to outpatient-pulmonary rehabilitation, and 1 compared home-based to outpatient pulmonary rehabilitation or usual care. The overall quality for most outcomes was considered low to very low, based on the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) tool. Health-related quality of life was measured across studies using the COPD assessment test, chronic respiratory disease questionnaire (CRQ), and the Saint George's respiratory questionnaire. In a meta-analysis comparing home-based to outpatient pulmonary rehabilitation in RCTs (n=2 studies) immediately after treatment, there were no differences between groups in changes in the dyspnea domain of the CRQ (MD=0.36; 95% CI, -1.34 to 2.06; p=.68), the emotional function domain of the CRQ (MD=-0.35; 95% CI, -0.83 to 0.14; p=.16), or the fatigue domain of the CRQ (MD=0.06; 95% CI, -1.16 to 1.27; p=.93). In all 4 studies comparing home-based to outpatient pulmonary rehabilitation, the 6MWD statistically significantly increased after both interventions, and the gains were similar between programs. This study demonstrated that there were no appreciable differences between home-based and outpatient pulmonary rehabilitation programs in short-term outcomes. A meta-analysis was not able to be performed on most outcomes due to a high level of heterogeneity and limited data. Additionally, long-term outcomes were not evaluated in included studies.
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) updates their guidelines annually on the diagnosis, management, and prevention of COPD (GOLD, 2023). In their 2023 guidance, GOLD notes that:
"Pulmonary rehabilitation should be considered as part of integrated patient management... Optimum benefits are achieved from programs lasting 6 to 8 weeks. Available evidence indicates that there are no additional benefits from extending pulmonary rehabilitation to 12 weeks. Supervised exercise training at least twice weekly is recommended, and this can include any regimen from endurance training, interval training, resistance/strength training; upper and lower limbs ideally should be included as well as walking exercise; flexibility, inspiratory muscle training and neuromuscular electrical stimulation can also be incorporated. In all cases the rehabilitation intervention (content, scope, frequency, and intensity) should be individualized to maximize personal functional gains."
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