Pulmonary Rehabilitation Reimbursement Challenges.

Pulmonary rehabilitation (PR) is a highly effective intervention for persons with chronic respiratory diseases, resulting in improvement in exercise capacity, dyspnea, health-related quality of life, mood, reduced hospitalization, and improved survival and cost savings post-COPD hospitalization. Despite demonstrated effectiveness, PR is underutilized in part due to lack of awareness, limited access, and inadequate PR reimbursement. Poor payment is a long-standing barrier to PR's financial stability and access. Addressing PR payment, access, and utilization is a complex challenge and requires strategic, collaborative long-term approaches to meaningful solutions. Strategies to overcome payment disparities begin with legislative approaches to address limitations of Centers for Medicare and Medicaid Services coverage. Additional priorities include permanent approval for remote physician and advanced practice provider (APP) PR supervision, PR referrals by APPs, telerehabilitation using two-way audio/video technology, and elimination of the PR lifetime maximum limit of 72 h or units/patient. Methods are needed to effectively link appropriate PR prescribing and encouragement with primary care providers, hospitalists, case managers, and hospital navigators to optimize PR referrals. There is an important need to address inadequate PR access in rural settings. Potential opportunities to improve PR referrals and access include exploration of PR synergies with value-based care models that emphasize high-quality care and cost savings. Development and use of effective PR provider tools and resources may help address the above challenges as well as financially benefit PR programs.

Pulmonary Specialist-Supported Health Coaching Delivered by Lay Personnel Improves Receipt of Quality Care for Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial.

Purpose: Half of people living with chronic obstructive pulmonary disease (COPD) do not receive high-quality, evidenced-based care as described in international guidelines. We conducted secondary data analysis of a previously published study to assess the ability of a model of lay health coaching to improve provision of guideline-based care in a primary care setting. Methods: As part of a randomized controlled trial, we recruited English- and Spanish-speaking patients with moderate to severe COPD from primary care clinics serving a low-income, predominantly African American population. Participants were randomized to receive usual care or 9 months of health coaching from primary care personnel informed by a pulmonary specialist practitioner. Outcome measures included prescription of appropriate inhaler therapy, participation in COPD-related education, engagement with specialty care, prescription of smoking cessation medications, and patient ratings of the quality of care. Results: Baseline quality measures did not differ between study arms. At 9 months, coached patients were more likely (increase of 9.3% over usual care; P=0.014) to have received guideline-based inhalers compared to those in usual care. Coached patients were more likely to engage with pulmonary specialty care (increase of 8.3% over usual care with at least 1 visit; P=0.04) and educational classes (increase of 5.3% over usual care; P=0.03). Receipt of smoking cessation medications among patients smoking at baseline in the health coaching group increased 21.1 percentage points more than in usual care, a difference near statistical significance (P=0.06). Conclusions: Health coaching may improve the provision of quality chronic illness care for conditions such as COPD.

Pulmonary Rehabilitation for Adults with Chronic Respiratory Disease: An Official American Thoracic Society Clinical Practice Guideline.

Background: Despite the known benefits of pulmonary rehabilitation (PR) for patients with chronic respiratory disease, this treatment is underused. Evidence-based guidelines should lead to greater knowledge of the proven benefits of PR, highlight the role of PR in evidence-based health care, and in turn foster referrals to and more effective delivery of PR for people with chronic respiratory disease. Methods: The multidisciplinary panel formulated six research questions addressing PR for specific patient groups (chronic obstructive pulmonary disease [COPD], interstitial lung disease, and pulmonary hypertension) and models for PR delivery (telerehabilitation, maintenance PR). Treatment effects were quantified using systematic reviews. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to formulate clinical recommendations. Recommendations: The panel made the following judgments: strong recommendations for PR for adults with stable COPD (moderate-quality evidence) and after hospitalization for COPD exacerbation (moderate-quality evidence), strong recommendation for PR for adults with interstitial lung disease (moderate-quality evidence), conditional recommendation for PR for adults with pulmonary hypertension (low-quality evidence), strong recommendation for offering the choice of center-based PR or telerehabilitation for patients with chronic respiratory disease (moderate-quality evidence), and conditional recommendation for offering either supervised maintenance PR or usual care after initial PR for adults with COPD (low-quality evidence). Conclusions: These guidelines provide the basis for evidence-based delivery of PR for people with chronic respiratory disease.

Rehabilitation for People with Respiratory Disease and Frailty: An Official American Thoracic Society Workshop Report.

People with respiratory disease have increased risk of developing frailty, which is associated with worse health outcomes. There is growing evidence of the role of rehabilitation in managing frailty in people with respiratory disease. However, several challenges remain regarding optimal methods of identifying frailty and delivering rehabilitation for this population. The aims of this American Thoracic Society workshop were to outline key definitions and concepts around rehabilitation for people with respiratory disease and frailty, synthesize available evidence, and explore how programs may be adapted to align to the needs and experiences of this population. Across two half-day virtual workshops, 20 professionals from diverse disciplines, professions, and countries discussed key developments and identified opportunities for future research, with additional input via online correspondence. Participants highlighted a "frailty rehabilitation paradox" whereby pulmonary rehabilitation can effectively reduce frailty, but programs are challenging for some individuals with frailty to complete. Frailty should not limit access to rehabilitation; instead, the identification of frailty should prompt comprehensive assessment and tailored support, including onward referral for additional specialist input. Exercise prescriptions that explicitly consider symptom burden and comorbidities, integration of additional geriatric or palliative care expertise, and/or preemptive planning for disruptions to participation may support engagement and outcomes. To identify and measure frailty in people with respiratory disease, tools should be selected on the basis of sensitivity, specificity, responsiveness, and feasibility for their intended purpose. Research is required to expand understanding beyond the physical dimensions of frailty and to explore the merits and limitations of telerehabilitation or home-based pulmonary rehabilitation for people with chronic respiratory disease and frailty.

Pulmonary Rehabilitation in Persons With COPD.

Pulmonary rehabilitation (PR) is a high-value intervention for persons with COPD and other chronic lung diseases. It is associated with improvement in exercise capacity, dyspnea, health-related quality of life, and depression as well as a reduction in hospitalization and improved survival when PR follows COPD-related hospitalizations. PR is underused in the United States and other countries despite strong evidence of both clinical effectiveness and cost-effectiveness. Additional challenges include a lack of equitable reimbursement and poor access, particularly in rural settings. Models, for example, virtual PR, may be an option for improving access but coverage in the United States by Medicare is tenuous. In addition, virtual PR models have considerable heterogeneity, which challenges uniform efficacy and selection of optimal candidates.

Survival after inpatient or outpatient pulmonary rehabilitation in patients with fibrotic interstitial lung disease: a multicentre retrospective cohort study.

BACKGROUND: The impact of pulmonary rehabilitation (PR) on survival in patients with fibrotic interstitial lung disease (ILD) is unknown. Given the challenges conducting a large randomised controlled trial, we aimed to determine whether improvement in 6-minute walk distance (6MWD) was associated with better survival. METHODS: This retrospective, international cohort study included patients with fibrotic ILD participating in either inpatient or outpatient PR at 12 sites in 5 countries. Multivariable models were used to estimate the association between change in 6MWD and time to death or lung transplantation accounting for clustering by centre and other confounders. RESULTS: 701 participants (445 men and 256 women) with fibrotic ILD were included. The mean±SD ages of the 196 inpatients and 505 outpatients were 70±11 and 69±12 years, respectively. Baseline/changes in 6MWD were 262±128/55±83 m for inpatients and 358±125/34±65 m for outpatients. Improvement in 6MWD during PR was associated with lower hazard rates for death or lung transplant on adjusted analysis for both inpatient (HR per 10 m 0.94, 95% CI 0.91 to 0.97, p<0.001) and outpatient PR (HR 0.97, 95% CI 0.95 to 1.00, p=0.042). Participation in ≥80% of planned outpatient PR sessions was associated with a 33% lower risk of death (95% CI 0.49% to 0.92%). CONCLUSIONS: Patients with fibrotic ILD who improved physical performance during PR had better survival compared with those who did not improve performance. Confirmation of these hypothesis-generating findings in a randomised controlled trial would be required to definitely change clinical practice, and would further support efforts to improve availability of PR for patients with fibrotic ILD.

Defining Modern Pulmonary Rehabilitation. An Official American Thoracic Society Workshop Report.

Pulmonary rehabilitation is a highly effective treatment for people with chronic lung disease but remains underused across the world. Recent years have seen the emergence of new program models that aim to improve access and uptake, including telerehabilitation and low-cost, home-based models. This workshop was convened to achieve consensus on the essential components of pulmonary rehabilitation and to identify requirements for successful implementation of emerging program models. 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, as well as 27 desirable components. Only those models of pulmonary rehabilitation that have been tested in clinical trials are currently considered as ready for implementation. The characteristics of patients most likely to succeed in each program model are not yet known, and research is needed in this area. Health professionals should use clinical judgment to determine those patients who are best served by a center-based, multidisciplinary rehabilitation program. A comprehensive patient assessment is critical for personalization of pulmonary rehabilitation and for effectively addressing individual patient goals. Robust quality-assurance processes are important to ensure that any pulmonary rehabilitation service delivers optimal outcomes for patients and health services. Workforce capacity-building and training should consider the skills necessary for emerging models, many of which are delivered remotely. The success of all pulmonary rehabilitation models will be judged on whether the essential components are delivered and on whether the expected patient outcomes, including improved exercise capacity, reduced dyspnea, enhanced health-related quality of life, and reduced hospital admissions, are achieved.

Mobile health technology to improve emergent frailty after lung transplantation.

We evaluated the feasibility, safety, and efficacy of a mHealth-supported physical rehabilitation intervention to treat frailty in a pilot study of 18 lung transplant recipients. Frail recipients were defined by a short physical performance battery (SPPB score ≤7). The primary intervention modality was Aidcube, a customizable rehabilitation mHealth platform. Our primary aims included tolerability, feasibility, and acceptability of use of the platform, and secondary outcomes were changes in SPPB and in scores of physical activity, and disability measured using the Duke Activity Status Index (DASI) and Lung Transplant-Value Life Activities (LT-VLA). Notably, no adverse events were reported. Subjects reported the app was easy to use, usability improved over time, and the app enhanced motivation to engage in rehabilitation. Comments highlighted the complexities of immediate post-transplant rehabilitation, including functional decline, pain, tremor, and fatigue. At the end of the intervention, SPPB scores improved a median of 5 points from a baseline of 4. Physical activity and patient-reported disability also improved. The DASI improved from 4.5 to 19.8 and LT-VLA score improved from 2 to 0.59 at closeout. Overall, utilization of a mHealth rehabilitation platform was safe and well received. Remote rehabilitation was associated with improvements in frailty, physical activity and disability. Future studies should evaluate mHealth treatment modalities in larger-scale randomized trials of lung transplant recipients.

Home Oxygen Therapy for Adults with Chronic Lung Disease. An Official American Thoracic Society Clinical Practice Guideline.

Background: Evidence-based guidelines are needed for effective delivery of home oxygen therapy to appropriate patients with chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD).Methods: The multidisciplinary panel created six research questions using a modified Delphi approach. A systematic review of the literature was completed, and the Grading of Recommendations Assessment, Development and Evaluation approach was used to formulate clinical recommendations.Recommendations: The panel found varying quality and availability of evidence and made the following judgments: 1) strong recommendations for long-term oxygen use in patients with COPD (moderate-quality evidence) or ILD (low-quality evidence) with severe chronic resting hypoxemia, 2) a conditional recommendation against long-term oxygen use in patients with COPD with moderate chronic resting hypoxemia, 3) conditional recommendations for ambulatory oxygen use in patients with COPD (moderate-quality evidence) or ILD (low-quality evidence) with severe exertional hypoxemia, 4) a conditional recommendation for ambulatory liquid-oxygen use in patients who are mobile outside the home and require >3 L/min of continuous-flow oxygen during exertion (very-low-quality evidence), and 5) a recommendation that patients and their caregivers receive education on oxygen equipment and safety (best-practice statement).Conclusions: These guidelines provide the basis for evidence-based use of home oxygen therapy in adults with COPD or ILD but also highlight the need for additional research to guide clinical practice.

Medical Director Responsibilities for Outpatient Pulmonary Rehabilitation Programs in the United States: 2019: A STATEMENT FOR HEALTH CARE PROFESSIONALS FROM THE AMERICAN ASSOCIATION OF CARDIOVASCULAR AND PULMONARY REHABILITATION (AACVPR).

Clinical guidelines have been developed recognizing pulmonary rehabilitation (PR) as a key component in the management of patients with chronic lung disease. The medical director of a PR program is a key player in every program and is a requirement for operation of the program. The medical director must be a licensed physician who has experience in respiratory physiology management. The purpose of this document is to provide an update regarding the clinical, programmatic, legislative, and regulatory issues that impact PR medical directors in North America. It describes the clinical rationale for physician involvement, relevant legislative and regulatory requirements, and resources available that the medical director can utilize to promote evidence-based and cost-effective PR services. All pulmonary rehabilitation (PR) programs must include a medical director. There are many clinical, programmatic, legislative, and regulatory issues that impact the PR medical director. The purpose of this document is to concentrate on the unique roles and responsibilities of the PR medical director.

Survey of Exercise Prescription in US Pulmonary Rehabilitation Programs.

PURPOSE: Pulmonary rehabilitation (PR) is the standard of care for chronic, symptomatic lung disease. Current scientific and clinical guidelines recommend PR to improve dyspnea, functional capacity, and quality of life. Several PR guidelines provide recommendations about the mode, intensity, duration, frequency, and progression of exercise-based interventions. There are variations in the components of PR exercise prescription that may influence the response to PR, as well as variations in how the exercise prescription and its components are determined and monitored. Therefore, the purpose of this investigation was to identify current PR exercise prescription practices via survey sent to 1758 PR programs in the United States. METHODS: The American Association of Cardiovascular and Pulmonary Rehabilitation administered surveys in 2013 and 2016 to US-based PR providers. RESULTS: Responses were returned from 371 PR providers (vs 380 in 2013). There was an increase in responses for all options describing exercise prescription methodology in the 2016 survey, with each element (frequency, intensity, time [duration], and type [mode]; FITT) demonstrating significant increase in use. There was a significant increase in 3 methods of determining exercise goals in 2016 versus 2013: duration (P = .017), distance (P = .010), and metabolic equivalents of task (P ≤ .001). CONCLUSIONS: The 2016 survey responses show a greater use of guideline-based exercise prescription methodology, with an increase in use of FITT methodology for exercise prescription.

Comparison of outcomes and cost-effectiveness of trisacryl gelatin microspheres alone versus combined trisacryl gelatin microspheres and gelatin sponge embolization in uterine fibroid embolization.

BACKGROUND: Uterine fibroid embolization (UFE) is an effective treatment for uterine leiomyomata. Optimizing the choice of embolic agents is imperative to achieve better patient outcomes with maximum resource utilization. PURPOSE: To evaluate the efficacy and cost-effectiveness of trisacryl gelatin microspheres (TAGM) versus combined TAGM and gelatin sponge (GS) embolization in the treatment of symptomatic uterine leiomyomata. MATERIAL AND METHODS: Between July 2007 and December 2010, 106 consecutive patients underwent UFE with TAGM. Between January 2011 and December 2016, 123 consecutive patients underwent UFE with a combination of TAGM/GS. The primary outcomes were successful infarction rate (≥90% infarction) of the dominant leiomyoma and percentage reduction in uterine and dominant leiomyoma volume on MRI at six months. Secondary outcomes included adverse event rates, pain scores, and change in clinical symptoms at six months. The embolic agents utilized per procedure were recorded and a cost-effectiveness analysis was performed. RESULTS: Baseline characteristics of both groups were similar. Successful infarction was achieved in 93.2% of the TAGM group and 94.6% of the TAGM/GS group (P = 0.52). Reduction in uterine volume (TAGM 40.7%, TAGM/GS 44.4%, P = 0.16) and dominant leiomyoma volume (TAGM 47.6%, TAGM/GS 50.1%, P = 0.29) at six months was similar. No significant difference was observed in symptom improvement at six months (P = 0.8). The mean number of TAGM vials utilized and cost per procedure was 6.3 and $1688.40 for TAGM embolization and 3.6 and $979.50 for TAGM/GS embolization, respectively. CONCLUSION: Primary and secondary outcomes were comparable when performing UFE with TAGM versus combined TAGM/GS. The combined use of TAGM/GS reduced the mean cost of embolic agents by 42%.

Strategies for recruitment and retention of underrepresented populations with chronic obstructive pulmonary disease for a clinical trial.

BACKGROUND: Recruitment and retention are two significant barriers in research, particularly for historically underrepresented groups, including racial and ethnic minorities, patients who are low-income, or people with substance use or mental health issues. Chronic obstructive pulmonary disease (COPD) is the third leading cause of death and disproportionately affects many underrepresented groups. The lack of representation of these groups in research limits the generalizability and applicability of clinical research and results. In this paper we describe our experience and rates of recruitment and retention of underrepresented groups for the Aides in Respiration (AIR) COPD Health Coaching Study. METHODS: A priori design strategies included minimizing exclusion criteria, including patients in the study process, establishing partnerships with the community clinics, and ensuring that the health coaching intervention was flexible enough to accommodate patient needs. RESULTS: Challenges to recruitment included lack of spirometric data in patient records, space constraints at the clinic sites, barriers to patient access to clinic sites, lack of current patient contact information and poor patient health. Of 282 patients identified as eligible, 192 (68%) were enrolled in the study and 158 (82%) completed the study. Race, gender, educational attainment, severity of disease, health literacy, and clinic site were not associated with recruitment or retention. However, older patients were less likely to enroll in the study and patients who used home oxygen or had more than one hospitalization during the study period were less likely to complete the study. Three key strategies to maximize recruitment and retention were identified during the study: incorporating the patient perspective, partnering with the community clinics, and building patient rapport. CONCLUSIONS: While the AIR study included design features to maximize the recruitment and retention of patients from underrepresented groups, additional challenges were encountered and responded to during the study. We also identified three key strategies recommended for future studies of COPD and similar conditions. Incorporating the approaches described into future studies may increase participation rates from underrepresented groups, providing results that can be more accurately applied to patients who carry a disparate burden of disease. TRIAL REGISTRATION: This trial was registered at ClinicalTrial.gov at identifier NCT02234284 on August 12, 2014. Descriptor number: 2.9 Racial, ethnic, or social disparities in lung disease and treatment.

Optimizing Home Oxygen Therapy. An Official American Thoracic Society Workshop Report.

More than 1.5 million adults in the United States use supplemental oxygen for a variety of respiratory disorders to improve their quality of life and prolong survival. This document describes recommendations from a multidisciplinary workshop convened at the ATS International Conference in 2017 with the goal of optimizing home oxygen therapy for adults. Ideal supplemental oxygen therapy is patient-specific, provided by a qualified clinician, includes an individualized prescription and therapeutic education program, and offers oxygen systems that are safe, promote mobility, and treat hypoxemia. Recently, patients and clinicians report a growing number of problems with home oxygen in the United States. Oxygen users experience significant functional, mechanical, and financial problems and a lack of education related to their oxygen equipment-problems that impact their quality of life. Health care providers report a lack of readily accessible resources needed to prescribe oxygen systems correctly and efficiently. Patients with certain lung diseases are affected more than others because of physically unmanageable or inadequate portable systems. Analysis is needed to quantify the unintended impact that the Centers for Medicare and Medicaid Services Competitive Bidding Program has had on patients receiving supplemental oxygen from durable medical equipment providers. Studies using effectiveness and implementation research designs are needed to develop and evaluate new models for patient education, identify effective ways for stakeholders to interface, determine the economic benefit of having respiratory therapists perform in-home education and follow-up testing, and collaborate with technology companies to improve portable oxygen devices. Generation of additional evidence of the benefit of supplemental oxygen across the spectrum of advanced lung diseases and the development of clinical practice guidelines should both be prioritized.

Randomized Controlled Trial of Health Coaching for Vulnerable Patients with Chronic Obstructive Pulmonary Disease.

RATIONALE: Socioeconomically disadvantaged patients with chronic obstructive pulmonary disease (COPD) often face barriers to evidence-based care that are difficult to address in public care settings with limited resources. OBJECTIVES: To determine the benefit of health coaching for patients with moderate to severe COPD relative to usual care. METHODS: We conducted a randomized controlled trial of 9 months of health coaching versus usual care for English- or Spanish-speaking patients at least 40 years of age with moderate to severe COPD. Primary outcomes were COPD-related quality of life and the dyspnea subscale of the Chronic Respiratory Disease Questionnaire. Secondary outcomes were self-efficacy for managing COPD, exercise capacity (6-min walk test), and number of COPD exacerbations. Additional outcomes were COPD symptoms, lung function (forced expiratory volume in 1 s percent predicted), smoking status, bed days owing to COPD, quality of care (Patient Assessment of Chronic Illness Care), COPD knowledge, and symptoms of depression (Patient Health Questionnaire). Outpatient visits, emergency department visits, and hospitalizations were assessed by review of medical records. Generalized linear modeling was used to adjust for baseline values and account for clustering by clinic. RESULTS: Of 192 patients enrolled, 158 (82%) completed 9 months of follow-up. There were no significant differences between study arms for the primary or secondary outcomes. At 9 months, patients in the coached group reported better quality of care (mean Patient Assessment of Chronic Illness Care score, 3.30 vs. 3.18; adjusted P = 0.02) and were less likely to report symptoms of moderate to severe depression (Patient Health Questionnaire score, ≥15) than those in the usual care arm (6% vs. 20%; adjusted P = 0.01). During the study, patients in the coaching arm had 48% fewer hospitalizations related to COPD (0.27/patient/yr vs. 0.52/patient/yr), but this difference was not significant in the adjusted analysis. CONCLUSIONS: These results help inform expectations regarding the limitations and benefits of health coaching for patients with COPD. They may be useful to health policy experts in assessing the potential value of reimbursement and incentives for health coaching-type activities for patients with chronic disease. Clinical trial registered with www.clinicaltrials.gov (NCT02234284).