Outpatient pulmonary rehabilitation (PR) is a core component of the management of patients with a variety of chronic lung diseases including chronic obstructive pulmonary disease (COPD), interstitial lung disease, and pulmonary vascular lung disease. Evidence has shown that participation in PR improves exercise performance, improves health-related quality of life, reduces dyspnea, and reduces health care utilization.1,2 Clinical guidelines have been developed throughout the world recognizing PR as a key component for the management of patients with COPD.3–6
Legislation passed by the United States Congress in 2008 stipulated that a medical director is required for the operation a PR program. From that statute, the Centers for Medicare & Medicaid Services (CMS) published a coverage regulation defining PR as, “a physician supervised program that furnishes physician prescribed exercise, psychosocial assessment, and outcomes assessment.”7 As a result of this legislation and changes in the science and practice of PR over the last decade, the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) deemed it important and necessary to develop a statement on the roles and responsibilities of a PR medical director in a fashion similar to the statement developed for medical directors of cardiac rehabilitation.8
The purpose of this document is to provide an update regarding clinical, programmatic, legislative, and regulatory issues that impact PR medical directors in the United States. It is not meant to repeat information regarding PR programming that can be found in guidelines and statements elsewhere.9 Rather, this document concentrates on the unique roles and responsibilities of the PR medical director. It describes the clinical rationale for physician involvement, the information needed to help physicians develop the appropriate skill sets, the relevant regulatory and legislative requirements, and the resources available that the medical director can utilize to promote evidence-based and cost-effective PR services. As a result, improvement in patient outcomes, patient satisfaction, and employee satisfaction should occur.
GENERAL QUALIFICATIONS AND SKILLS OF THE MEDICAL DIRECTOR
The minimum qualifications of a PR medical director are defined in current legislative and regulatory documents.7 The medical director must be a physician (MD or DO) who is licensed in the same state as the PR services that are being provided and have expertise in respiratory physiology and management of patients with chronic lung disease. The medical director does not need to be a pulmonologist. The medical director should be appropriately credentialed within his/her institution(s) and should be contracted in such a way that he/she has the time to devote to the responsibilities that are associated with this role. The medical director should make a commitment to stay abreast of new regulatory developments as well as participate in continuing medical education related to chronic lung disease with emphasis on rehabilitation and prevention of disease. Skills in data collection and analysis, outcomes assessment, and quality improvement strategies are desirable to facilitate interaction with others in the health care setting within which the rehabilitation program resides. Core competencies for the PR program medical director are outlined in Table 1.
Leadership and communication skills are an asset to a medical director whose role is to guide a multidisciplinary team of health care professionals directly involved in the provision of PR services as well as to communicate with other health care providers and administrative leadership. In this era of increasing accountability for health care outcomes and value-based purchasing, the medical director of a PR program is uniquely positioned to guide the program to demonstrate cost-effective care.
THE PATIENT AND THE MEDICAL DIRECTOR
PR has been shown to be beneficial but is greatly underutilized.10–13 Medical directors play an important and influential role to help educate physicians, institution leaders, third-party payers, and patients about the prevalence of chronic lung disease and the benefits associated with PR. The medical director is often in an excellent position to foster relationships with health care administrators and other health providers and payers that can lead to improved understanding about the value of PR services. As medical institutions work to expand services and patient access through a variety of locations, medical directors need to work in partnership with the PR program director/manager and staff to evaluate referred patients and plan an appropriate individualized rehabilitation treatment plan (ITP) as well as develop and implement electronic medical record changes that foster consultation and collaboration with acute care and outpatient providers and payers.
Each patient must be under the care of a health care provider (physician or advance practice provider, such as a nurse practitioner or physician's assistant) and be referred to the program by that provider. While the initial referral comes from this health care provider, the medical director is ultimately responsible for determining the appropriateness of patient admission to the program and the rehabilitation plan of care. The medical director is also responsible for all policies related to the referral of patients including inclusion and exclusion criteria for program entry.
The medical director and the clinical program director should be knowledgeable of the policies related to medical coverage of PR services. In the United States, these policies include those of the CMS, Medicare Administrative Contractors (MAC), and commercial health insurers. Specific requirements for coverage, patient copayments, and processes for authorization often differ among varying types of payers.14,15 In other countries, such policies are determined by the province/country within which the PR program resides.
PATIENT INCLUSION AND EXCLUSION CRITERIA
Although any patient with symptomatic, disabling chronic lung disease, despite otherwise optimal medical treatment, may be appropriate to refer to a PR program, the specific conditions most commonly representing referral to PR are included in Table 2. Exclusion criteria include any condition that interferes with the ability of the patient to participate fully in PR activities and are listed in Table 3.
INITIAL EVALUATION AND GOAL DEVELOPMENT
Comprehensive PR programs should address each of the core components described in the AACVPR Guidelines for Pulmonary Rehabilitation Programs (5th edition) and include initial patient assessment, collaborative self-management education, supervised exercise training, psychosocial intervention, and patient-centered outcome assessment.9 The medical director can assist staff to address any medical issues related to these core components and to determine the appropriateness of individual patient participation in a PR program.
The medical director and program staff should ensure that the necessary resources are available to obtain the clinical information needed to perform a comprehensive patient assessment and develop a patient-centered treatment plan. Such resources include:
- Verification of the presence of chronic lung disease. This may include progress notes from referring physicians and other health providers, objective findings from spirometry and pulmonary function tests, radiographic and imaging information, exercise test results, sleep assessments, electrocardiography, results of evaluations of other comorbid conditions (eg. echocardiograms, nuclear medicine tests, and bone density testing)
- Review of pulmonary risk factors including smoking history and current smoking status, exposure to second-hand smoke, family history of lung disease (eg, test results for α-1 antitrypsin deficiency), and occupational exposures
- Identification and status of comorbid conditions such as depression, anxiety, pulmonary hypertension, peripheral arterial disease, gastroesophageal reflux, sleep-disordered breathing, coronary artery disease, diabetes, bone and joint disease, and lung cancer
- Determination of the status of cardiopulmonary, orthopedic, neuromuscular, and cognitive systems
- Identification of any patient-specific symptoms such as dyspnea, exercise intolerance, fatigue, anxiety, panic episodes, depression, and psychological stressors
- Review of exercise limitations and performance of activities of daily living (ADL)
- Assessment of oxygenation status at rest and on exertion
- Review of the medications including prescription, over-the-counter, supplemental, and herbal medications; dosing intervals; suspected adherence; and the ability to administer inhaled medications
- Review of prescribed respiratory equipment such as small-volume nebulizers, oxygen delivery devices, and noninvasive ventilation
- Assessment of available social support
- Review of the occupational history and current employment status
- Identification of any health literacy, educational, and cognitive concerns
- Identification of range of motion limitations, fall risks, and assistive device use
- Assessment of knowledge and understanding of lung disease and treatments
- Assessment of readiness and motivation to participate
- Evaluation of exacerbation history (including previous hospitalizations)
TREATMENT PLAN DEVELOPMENT
Results and findings from the comprehensive initial evaluation must be documented to reflect the current status of the patient, including the identification of any patient problems and recommendations for follow-up. The PR ITP should include specific goals for improving self-care skills, exercise training, ADL performance, psychosocial and emotional support, and dietary/nutritional counseling. Patient progress should be monitored and documented at each session. The medical director and the program director/manager have a responsibility to consult and interact with PR team members to oversee the progress of each patient. The medical director may meet with clinicians to review clinical findings and re-evaluate and re-set training goals, as appropriate.
The initial patient evaluation and goal development process is a team effort involving the patient, the referring physician or other health care provider, all PR program clinicians, and the medical director. Findings and recommendations resulting from the initial evaluation should be communicated to the patient and the primary health care provider to support the collaborative patient-centered care. Discharge reports reviewing the individual summary of patient progress should be communicated with the referring primary care provider. Patient outcomes that reflect progress toward goals should be documented and tracked to identify specific areas that require further intervention and monitoring.
CLINICAL OUTCOME MONITORING
Patient-centered clinical outcomes help to address the effectiveness of an intervention and the progress of the individual patient within the program. These outcomes can also be used to evaluate the overall effectiveness of the program in meeting its quality improvement goals and can be used as part of AACVPR certification. These measurable outcomes should address a minimum of 3 areas: exercise capacity, symptoms (eg, dyspnea and fatigue), and health-related quality of life (health status). In addition to these areas, the program may choose to assess other important outcome areas (eg, depression, anxiety, self-efficacy, or health care utilization). Collecting data on patient self-reported measures requires oversight to ensure adequate and accurate collection and analysis. These commitments and efforts require administrative support and the medical director needs to ensure that such support is maintained as a core component of the program.
The outcome measures used by a program should be evidence-based. Reliable and validated tools should be used for patient-centered assessments and program evaluation. In the United States, the CMS requires reporting of objective, measurable patient-centered outcomes. It is important to assess the response to treatment for each individual patient. Timing and collection of outcome data begins with the initial assessment and continues throughout the program until discharge and should continue throughout maintenance therapy.
SPECIAL CONSIDERATIONS (COMORBID CONDITIONS AND EXACERBATIONS)
Comorbid conditions are often present in patients who have COPD, with many patients having at least 5 comorbid conditions that significantly impact individual health status.16–18 These comorbidities include (but are not certainly limited to) anxiety, depression, osteoporosis, coronary artery disease, congestive heart failure, peripheral vascular disease, diabetes, sleep-disordered breathing, and lung cancer. The medical director should be aware of any potential comorbidities and review the overall therapy being provided. The medical director should help educate the rehabilitation team on the detection and management strategies for such comorbidities.
Exacerbations are frequently present in patients with COPD, with up to 75% of patients with COPD experiencing an exacerbation within the previous year.19 Exacerbations are costly to both the patient and the health care system in terms of both morbidity and related expenditures. For those hospitalized with a COPD exacerbation, up to 25% of patients require rehospitalization within 30 d following hospital discharge, thus resulting in a significant increase in health care related costs.20,21 Pulmonary rehabilitation has been shown to reduce health care resource use, including the 30-d rehospitalization rates, and should be incorporated into the hospital discharge planning process for every patient hospitalized with a COPD exacerbation.22 The medical director should play an important role in post-hospitalization PR by providing the appropriate education of patient hospital medical staff and primary care providers of the benefits that can be attained from PR following hospital discharge.
LEGISLATIVE AND REGULATORY ISSUES AND THE MEDICAL DIRECTOR
On January 1, 2010, CMS coverage rules for PR for patients with moderate to very severe COPD (GOLD stages of airflow limitation II-IV) paid for under Medicare part B were implemented.23 These rules include requirements related to the role of the physician, exercise, outcome and psychosocial assessment, and individualized treatment plan. These regulations were based on evidence-based research in the field at that time and form the basis for the provision (and reimbursement) of PR services.
CMS PR requirements outline what, how, when, and for whom PR is covered. PR is a physician-supervised, comprehensive program that includes mandatory components of physician-prescribed exercise, education or training, psychosocial and outcome assessment, and the ITP. Some aerobic exercise must be included in each PR session, described by the CMS as a combination of endurance and strength training. Objective clinical measures of PR effectiveness must be performed for each patient including exercise performance and self-reported measures of shortness of breath. Assessments should include functional evaluation (eg, 6-min walk test), self-reported dyspnea, and quality-of-life measurement. Other measures such as smoking status and supplemental oxygen use may also be included. Adoption of a plan for cardiopulmonary emergencies within the exercise area including appropriately trained staff response and availability of emergency equipment is required.
The CMS PR benefit includes extensive PR medical director requirements and responsibilities. PR is a physician-supervised, comprehensive program that includes mandatory components of physician-prescribed exercise. A physician must have initial, direct contact with the patient prior to PR services, and ≥1 direct contact with each patient every ≥30 d. The definition of “direct contact” has yet to be fully defined, and it is recommended that each facility contact the local MAC to determine the local definition for this term. A supervising physician must be immediately available and able to be interrupted for questions/emergencies during provision of PR services.
INDIVIDUALIZED TREATMENT PLAN
An ITP must be developed for each patient. The ITP is used to set goals with the participant, to track progress, and to communicate with other health care professionals. It is described as a written plan tailored to each individual patient that includes all of the following: a description of the diagnosis of the individual; the type, amount, frequency, and duration of the items and services furnished under the plan; and the goals set for the individual under the plan. In order to be clinically useful, the ITP should reflect the current status of the patient and guide the development and implementation of a patient-specific treatment plan that prioritizes goals and outlines intervention strategies for exercise training, and a follow-up plan that reflects progress toward goals and guides long-term secondary prevention strategies, including strategies to improve medication compliance. Findings and recommendations resulting from the initial evaluation should be communicated to both the patient and the referring health care provider. Patient outcomes that reflect progress toward goals should be documented and tracked to identify specific areas that require further intervention and monitoring in the future. While the ITP may be initially developed by the referring physician, the PR medical director must review and sign the ITP.
Once the ITP is established, it must be reviewed and signed by a physician (either the medical director or the referring physician), who is involved in the care of the patient and has knowledge related to his or her condition, every 30 d. The medical director should assure that policies and procedures are in place to formulate and implement the ITP and should help the PR program staff develop systems and processes to facilitate the flow of information to the other health care providers of the patient.
REIMBURSEMENT FOR SERVICES
Each billable PR session must be of a duration of ≥31 min and include some exercise. To clarify, this does not mean that 31 min of exercise is required. The CMS recognizes that imposing a strict standard of a minimum of 30 min of exercise is not realistic, as programs are highly individualized and many patients may not initially be able to participate in 30 min of aerobic exercise.23 The clinical parameters that are monitored in supervised PR sessions are determined based on individual patient need, in line with guiding departmental policies. Two sessions of PR are the maximum number of sessions/d covered by the CMS. To bill for 2 PR sessions in 1 d, total session duration would require ≥91 min of PR services with exercise during each session (not necessarily concurrent). This means some exercise is performed in the first session (defined by the CMS as the first 60-min duration) and some exercise in the second session (defined by the CMS as ≥31 min). Up to 36 sessions is considered a course of PR with the option of an additional 36 units if there is documentation of medical necessity. The CMS places a “lifetime limit” of 72 PR sessions for Medicare beneficiaries, despite future medical necessity. Therefore, it is in the best interest of the patient to provide enough sessions to be medically beneficial while reserving sessions for future medical needs. Although Medicare does not pre-authorize any services, extension of a PR course beyond 36 sessions would necessitate unequivocal documentation of medical necessity. All sessions billed beyond the initial 36 sessions, whether a current “course” or future “courses” (referrals with medical justification), require the use of an KX modifier on submitted claims. (The KX modifier indicates that the PR provider has ensured coverage criteria for the billed service have been met and that documentation does exist to support the medical necessity of item.) The total number of PR sessions utilized by a Medicare beneficiary is tracked via CMS software, such as CWF or HETS or C-SNAP or other similar CMS tracking programs, displayed in the software as counting down from 72 (none used to date as a Medicare beneficiary) to zero (no further coverage available as a Medicare beneficiary). There is no time limit on the duration of a PR course.
PR in a hospital setting is reimbursed according to the CY Hospital Outpatient Prospective Payment System. PR provided in a physician office is reimbursed by the CMS at a lower rate because reimbursement is calculated differently under the CY Physician Fee Schedule. Medicare-managed care plans must cover the same Medicare Part A and Part B services. However, CMS-managed care plans may expand coverage policies and may not limit a CMS patient in such a plan to 72 PR sessions over a lifetime.
The CMS uses a “bundled” Healthcare Common Procedure Coding System (HCPCS) code G0424 for patients with moderate to very severe COPD (GOLD stages of chronic airflow limitation II-IV). This bundled code precludes PR programs from billing separately for physician services, 6-min walk test, smoking cessation, or other “components” (eg, physical therapy) of PR in patients with COPD.
Coverage may be available for pulmonary disorders other than COPD as part of a MAC policy. Based on regional current MAC respiratory services local coverage determination (LCD), services for other respiratory diagnoses may be billed as “respiratory services” using HCPCS codes G0237, G0238, and G0239. These codes differ from the G0424 used for COPD. G0424 is a bundled code whereas G0237, G0238, and G0239 are not bundled codes. It is important for the medical director to be aware of any MAC LCDs that may exist and develop a working relationship with the MAC in their area. MACs may offer community training on billing for covered services. A more complete description of coding information may be found in the American College of Chest Physicians Coding for Chest Medicine 2016.24
In order to assure appropriate reimbursement for services provided by the rehabilitation team in the future, the medical director must be in regular contact with the hospital administration. It is important that the hospital accurately report all charges (costs) associated with the provision of PR services yearly. These reports help the CMS to adjust future reimbursement decisions for these services. Instructions on how to provide these services are available on a variety of professional organization (eg, AACVPR) websites.25
THE PROGRAM AND THE MEDICAL DIRECTOR
FACILITATING INDIVIDUALIZED PATIENT-CENTERED CARE
The medical director is defined as “a physician who oversees or supervises the PR program at a particular site.” The medical director should help the PR program staff develop protocols that facilitate individualized patient-centered care. This includes individualization of exercise training protocols, determination of the level of monitoring needed during exercise training, and individualization of chronic lung disease education, counseling, and treatment goals.
RESPONSIBILITIES RELATED TO PROGRAM DEVELOPMENT AND OPERATIONS
Responsibilities of the PR program medical director include direct participation in the processes of program development in the case of new programs and of subsequent program oversight and evaluation of effectiveness. To this end, the medical director should ensure that policies and procedures are consistent with evidence-based guidelines, comply with regulatory and certification standards, and recognize regulations for, and issues pertaining to, reimbursement for services. In addition, the medical directors should promote policies and practices aimed to improve PR access and delivery to all patients who could benefit, including traditionally underserved patient populations, to stress the interdisciplinary care of PR, and to facilitate clear, concise program documentation that maximizes communication among those responsible for patient health care.
Medical director participation in staff and patient education sessions can be invaluable to reinforce basic principles regarding the underlying disease and to provide information about recent developments in diagnostic procedures and treatments for patients with chronic lung disease, so that the PR team can be more effective in individualizing the treatment plan. Evaluation and goal development should address each of the core components of PR relevant to a patient. Other responsibilities of a PR medical director related to program development and operation are detailed in Table 4.
RESPONSIBILITIES RELATED TO TRACKING AND ASSURING PROGRAM EFFECTIVENESS
The PR medical director is responsible for overseeing PR program overall effectiveness in delivering high-quality services to all eligible patients within the program service area. To carry out these responsibilities, the medical director must oversee activities that utilize the following concepts and practices:
- Enlist the support of local physician and nonphysician leadership to support the role of PR services in providing high-quality care to patients with chronic lung disease. Efforts to bridge the gap in the delivery of quality PR services will be most successful when local leaders include PR as a priority area of focus for local quality improvement.
- Identify all eligible patients within the service area of the PR program. Unless eligible patients are properly identified, the medical director and staff of a PR program will have difficulty improving the impact of their services. Effective identification of eligible patients requires an active, collaborative approach with local hospitals and practices in which there is recognition of joint accountability for identifying and treating all patients in need of PR services. This approach is essential to extend the reach of PR services, to all eligible patients, but it is especially important for improving the delivery of care to those patient subgroups who are least likely to receive such services, including women, the elderly, and individuals from racial/ethnic minority groups. Hospitals, outpatient practices, and PR programs will need to develop innovative strategies and delivery models to help reduce barriers to and improve utilization of PR services.
- Deliver high-quality PR services to eligible patients. The delivery of quality PR services by PR professionals to eligible patients requires that programs incorporate core components and key competencies. Program certification is available through the AACVPR to help programs meet such quality standards.
- Apply quality improvement strategies. The application of quality improvement strategies includes the agreement of measurement targets, assessment of current performance and gaps in performance relevant to those targets, and adjustment of program policies and processes in response to such assessment.
- Utilize data collection system. Data collection systems are essential to assist in the implementation and assessment of quality improvement practices in the PR program. Medical directors should consider utilizing a database to track composite program outcomes, including those related to actual enrollment in PR after referral, to completion of the prescribed course of PR, and to improvements in health care–related outcomes.
MEDICAL DIRECTION IN OTHER COUNTRIES
PR in other countries is fundamentally intended to achieve the same goals as in the United States; however, there are inherent differences in system organization, delivery, and reimbursement. The most notable difference is the single-payer, publicly-funded, not-for-profit system entrenched in Canada and guided by the Canada Health Act.26 While national standards/goals are set, each province/territory is responsible for health care funding and delivery to their population. In this regard, PR is largely subsidized in Canada (although small user fees are common), but access is very restricted because of limited capacity. While the specific reasons may be different, barriers to participation in PR in Canada are as prevalent as they are in the United States. Regrettably, the results are also the same in that many patients with COPD, from both countries, are not able to realize the substantive benefits of PR. Change must happen (in both the Canadian and US health care systems as well as systems in other countries) to support and enable patients to participate in PR.3 Access to PR and adherence to participation remain two of the most significant challenges in this field. In Canada, it was estimated in 2007 that only 1.2% of Canadian COPD patients had access to PR.26 Less than a decade later that figure only rose to <5%.12
BARRIERS TO REFERRAL AND ALTERNATIVE DELIVERY METHODS
Acknowledging the important benefits of the intervention and appreciating that PR is now a standard of care for patients who remain symptomatic despite appropriate bronchodilator therapies, many obstacles to referral and initiation of PR do exist.6 It is not acceptable for health care providers, patients, or health care systems to accept the current status quo as the benefits following PR must not be ignored. Similarly, patients must advance their attitudes and behaviors, and accept PR as an integral component of their management.
Recent work has been undertaken throughout the world to partially address some of these concerns. Most importantly, there has been a palpable increase in funding to establish new PR programs and increase the capacity of existing programs. Innovative methods of program delivery are also being examined. PR has traditionally been delivered in the hospital (or near-hospital) setting. Non-hospital-based programs presently account for only 7% of the total programs accessible by patients in Canada but could be an alternative to hospital-based programs if effectiveness and coordination are assured.3 Significant improvement in health-related outcomes (dyspnea, cycling endurance time) was noted in a trial of home-based PR.27 In other models of care, rehabilitation delivered by telehealth was effective and demonstrated improvements in quality of life and exercise capacity comparable to standard PR.28–30 Acknowledging the vast geographic area and rural populations that exist throughout the world, the results of these studies have the potential to markedly increase access to PR.
The medical director of a PR program is a key person for the development and maintenance of a successful program. Changes in clinical practice, legislative regulations, and health care delivery models have made the role of the medical director even more critical for delivery of a high-quality program. Strong participation by a knowledgeable medical director, working collaboratively with the PR team and referring health care practitioners, is essential to assure that treatment is individualized, communication is optimized, and outcomes are tracked to provide a value-based program. PR medical directors must work within their communities to develop systems that will expand access to those patients who would benefit from rehabilitation. Successful program completion and ongoing patient adherence to the lessons learned during the program are issues that face all programs currently.31–33
There remain many gaps in the implementation, use, and delivery of PR services. The American Thoracic Society and European Respiratory Society discussed means to address these gaps with proposals to consider regarding enhancement of service delivery.34 A call for action for PR in the United States has been proposed.35 Each medical director should review and attempt to address these concepts, as we move into the future to “rehabilitate” PR.36
The role of the PR medical director as a team leader remains a core concept, but it is even more critical for the medical director to understand this role within the changing health care system. Delivery models will need to be designed to improve patient-centered outcomes and create value-based programs. Leading the PR team and medical community toward effective changes and continuous improvement in program delivery and patient outcomes remains one of the most important roles for all medical directors of PR.
OTHER RESOURCES (WEB BASED)
Physician Fee Schedule (PFS): www.federalregister.gov/OFRUpload/OFRData/2009-26502_PI.pdf
Hospital Outpatient Prospective Payment System (HOPPS): www.federalregister.gov/OFRUpload/OFRData/2009-26499_PI.pdf
AACVPR Legislative and Regulatory Resources: www.aacvpr.org/PolicyReimbursement/
ATS PR: Final Rule Medicare Coverage & Reimbursement: www.thoracic.org/sections/about-ats/advocacy/washington-letter/letters/september-7-2009.html.
Medicare Administrative Contractor Information: www.cms.hhs.gov/MedicareContractingReform/01_Overview.asp
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