Pulmonary Rehabilitation

This is a response to the request for input and comments specific to the Pulmonary Rehabilitation decision proposal. I am the coordinator of a hospital based Pulmonary Rehab program and have worked in Outpatient Pulmonary Rehab for 5 years. Our rehab is in a rural area and is the only Pulmonary Rehab to service 7 counties. Our standard frequency is 3 times per week. Due to the expansive area we cover, some patients attend only 2 times per week depending on their travel distance required. My data for June'06-June'07 shows successful completion of the program for 109 patients. The average duration is 18 visits. The range is 12- 28 visits. We have no preset frequency and duration because each pts. plan of treatment establishes individual goals. Discharge is appropriate when goals are met and pt.is capable of independent continuation. I find that the listed definitions of Pulmonary Rehab and the components are the same as the ones I would state. I have provided Pulmonary Rehab in a CORF setting and in an outpatient hospital setting. In my opinion, the hospital setting has a better chance to offer all necessary disciplines for optimal coverage of all patient needs. We use patient questionaires to establish subjective improvements, and data such as 6MW test, pulmonary function studies, BORG scale and SpO2 readings and therapist evaluations to document objective improvements. Thank you for considering my comments in you decision.

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I believe that pulmonary rehabilitation should be covered by Medicare across the 50 states uniformly. The need for patients to have the availability of pulmo rehab is undisputable and if not covered by Medicare may not be a possibility for all the people who have any COPD family of diseases. It will definitely assist the patient in approaching exercise intelligently and under the supervision of professionals. With the rehab and a continuing exercise program, patients can extend their life, reduce medical costs and enjoy life to it's fullest.I would urge those persons responsible for the dec9ision making process to add pulmonary rehabilitation to it's list of approved treatments covered by our monthly contributions as well as those made during out working lives.

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It appears that there are several issues present in this discussion. According to your own determination, pulmonary retraining and reconditioning is reasonable and necessary, as well as effective. The first issue is how the service is classified - pulmonary rehab vs. respiratory therapy services. According to your determination, treatments provided in a CORF as respiratory therapy services are covered while the same services covered in another outpatient setting as pulmonary rehab are not covered. There are two problems with this logic. The first is that the respiratory therapy services vs. pulmonary rehab issue is merely a matter of semantics. You could refer to the same services in an outpatient setting as "respiratory therapy services" and consider them to be covered. The second problem is the assumption, because the degree of regulation is not as rigorous for outpatient settings as for CORF settings, that an outpatient rehab program cannot, a priori, provide the same level of care as a CORF. The logical conclusion from this fallacious assumption is that these outpatient centers, therefore, must provide only individual components of a comprehensive pulmonary rehab program (or independent respiratory therapy services) rather than comprehensive services. Although this may be true in some outpatient settings, it certainly is not true in all instances. The final issue is that of need. Many of the views already expressed have stated the need far more eloquently than that of which I am capable of doing. The essence of the point, however, is that pulmonary disease, in all its manifestations, is not going to go away on its own. As stewards of the health and well-being of others, it is incumbent upon us to provide our patients with every opportunity to live full and rewarding lives of the highest quality possible. This may only be done if every weapon available in our arsenal is, actually, in our arsenal. Pulmonary rehab, by any name, is a cost-effective means of providing improved quality of life to our patients. It is not a cure. We know that and, more importantly, our patients know that. What we do know, however, is that this form of therapy is a source of hope for a more normal life for those who, previously, had no such hope.

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On behalf of 30,000 Americans with cystic fibrosis (CF), we urge you to provide Medicare coverage for pulmonary rehabilitation for individuals with this disease, in conjunction with your decision to cover people with chronic obstructive pulmonary disease (COPD) in 42 CFR 410.100(e)(1) to (2)(vi).

CF is a life-threatening disease, which affects the lungs, digestive and reproductive systems. The median life expectancy is about 37 years of age, which is an improvement from several decades ago when children died while still in elementary school. Approximately 10,000 individuals with CF, or more than 40 percent of the population, have now reached adulthood. People who become disabled by CF and eligible for Medicare are sicker and more likely to develop serious complications from the disease, including lung transplantation. Pulmonary rehabilitation, including but not limited to chest physical therapy and exercise, can help individuals with CF enjoy healthier lives. In the 'Cystic fibrosis adult care: consensus conference report,' pulmonary rehabilitation is noted as a beneficial intervention for this population. (Yankaskas JR, Marshall BC, Sufian B, Simon RH, Rodman D. Cystic fibrosis adult care: consensus conference report. Chest 2004 Jan;125(1 Suppl):1S-39S.)

Individuals with CF must adhere to a time-intensive daily regimen of medications and airway clearance treatments in order to maintain their health. Complications from CF include increasingly frequent hospitalizations, and eventually lung transplantation to stay alive. Individuals with CF will benefit from pulmonary rehabilitation to live longer, and stay healthy enough to obtain and survive lung transplants.

Pulmonary rehabilitation is an essential component for individuals before and after lung transplantation. Evidence shows that those individuals in better physical shape will have an increased chance of surviving and thriving after a transplant. (Takaoka ST, Weinacker AB. 'The value of preoperative pulmonary rehabilitation.'' Thorac Surg Clin. 2005 May;15(2);203-11.)

According to the Cystic Fibrosis Foundation's National Patient Registry, approximately 775 adults currently living with CF have been evaluated for lung transplants since 2000, and nearly 260 of those have received new lungs. Medicare coverage of pulmonary rehabilitation for people with CF to obtain lung transplants is a critical component and is part of the treatment regimen prescribed by physicians at CF care centers.

While Medicare provides coverage for people with CF once they have become disabled by the disease, it plays an influential role in private sector coverage. Pulmonary rehabilitation is valuable for individuals to maintain their health while they are working and helps prevent them from becoming disabled at an earlier age. To the extent that private insurance follows Medicare's lead, covering pulmonary rehabilitation could help keep individuals healthier and in the work force paying taxes longer.

We are pleased that CMS is considering expanding coverage for pulmonary rehabilitation and urge CMS to cover this benefit for CF. We appreciate the opportunity to work with CMS to address access to this benefit to help beneficiaries with CF stay healthier longer. Please contact me at 301-907-2548 or spattee@cff.org if you have questions.

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As an experienced health professional who has worked in the field of pulmonary rehabilitation and chronic lung disease for more than 25 years both as a clinician and academic investigator, I wish to provide my strongest possible support for the thoughtful, reasoned, and reasonable response from the leading professional organizations in our field (ATS, ACCP, AACVPR, NAMDRC) asking that CMS reconsider its proposed decision not to establish a national coverage policy for pulmonary rehabilitation. Clearly the rapidly increasing body and weight of scientific evidence as documented both in the literature and in CMS's own technology assessments establish that comprehensive pulmonary rehabilitation as currently practiced produces substantial benefits for disabled patients with chronic lung diseases and, in fact, helps to reduce the expenditure of increasingly expensive health care resources in this patient population. The incorporation of recommendations for pulmonary rehabilitation in every practice guideline for the treatment of COPD published anywhere in the world for at least the past decade demonstrates that the worldwide medical community recognizes pulmonary rehabilitation as a standard of care in the treatment of patients with advanced lung disease. As the country that has taken the lead in conducting the research and developing appropriate standards and practice guidelines for pulmonary rehabilitation, it would be most unfortunate to deny the benefits of these services for the large majority of our own citizens with disabling advanced chronic lung diseases who rely on CMS for medical coverage and for setting the standards that many other third party payors follow.

I sincerely hope, and urge, that CMS reconsider this unfortunate decision that will adversely affect the health of so many deserving patients.

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This is an important program for those suffering with lung disease. I do not under stand how much more evidence does one need, Pulmonary Rehab works and saves us Medicare dollars! New Guidelines Highlight Benefits of Pulmonary Rehabilitation News Author: Laurie Barclay, MDCME Author: Charles Vega, MD Disclosures June 13, 2007 The joint American College of Chest Physicians (ACCP) and American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) evidence-based clinical practice guidelines for pulmonary rehabilitation, published in a May supplement issue of Chest, offer new evidence of that rehabilitation is beneficial for patients with chronic obstructive pulmonary disease (COPD) and those with other chronic lung conditions.

The new recommendations, which are updated from 1997, highlight longer-term rehabilitation, maintenance strategies, and strength training, as well as supplemental oxygen use during rest and exercise for those with severe hypoxemia.

"Pulmonary rehabilitation has emerged as a recommended standard of care for patients with chronic lung disease based on a growing body of scientific evidence," write Andrew L. Ries, MD, MPH, FCCP, from the University of California, San Diego, School of Medicine, and colleagues. "A previous set of evidence-based guidelines was published in 1997 as a joint effort of the American College of Chest Physicians (ACCP) and the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR). Since then, the published literature in pulmonary rehabilitation has increased substantially, and other organizations have published important statements about pulmonary rehabilitation (eg, the American Thoracic Society and the European Respiratory Society)."

Based on a systematic review of published literature from 1996 to 2004, the ACCP Clinical Research Analyst prepared evidence tables, which were reviewed by the guideline panel. The updated recommendations also evaluate new areas of research relevant to pulmonary rehabilitation. Recommendations were developed by consensus and rated based on the ACCP guideline grading system.

The new evidence supports the earlier guidelines that recommend lower and upper extremity exercise training and that document improvements with pulmonary rehabilitation in dyspnea and health-related quality-of-life outcomes. Although additional evidence demonstrates improvements in healthcare utilization and psychosocial outcomes, there is little new evidence regarding survival.

Some new evidence highlights the benefits of longer-term rehabilitation, maintenance strategies following rehabilitation, and incorporating education and strength training into pulmonary rehabilitation.

Based on evidence available to date, the routine use in pulmonary rehabilitation of inspiratory muscle training, anabolic drugs, or nutritional supplementation cannot be recommended. However, available evidence supports the use of supplemental oxygen therapy for patients with severe hypoxemia at rest or with exercise. For selected patients with advanced COPD, noninvasive ventilation may be helpful. The guidelines also report that pulmonary rehabilitation appears to help patients with chronic lung diseases other than COPD.

"There is substantial new evidence that pulmonary rehabilitation is beneficial for patients with COPD and other chronic lung diseases," the authors write. "Several areas of research provide opportunities for future research that can advance the field and make rehabilitative treatment available to many more eligible patients in need."

Specific recommendations in the updated guidelines are as follows:

For patients with COPD, a program of exercise training of the muscles of ambulation should be a mandatory component of pulmonary rehabilitation (grade of recommendation, 1A).
In patients with COPD, pulmonary rehabilitation improves the symptom of dyspnea (1A).In patients with COPD, pulmonary rehabilitation improves health-related quality of life (1A).
In patients with COPD, pulmonary rehabilitation reduces the number of hospital days and other measures of healthcare utilization (2B).
In patients with COPD, pulmonary rehabilitation is cost-effective (2C).
Evidence is insufficient to determine if pulmonary rehabilitation improves survival in patients with COPD.
Comprehensive pulmonary rehabilitation programs provide psychosocial benefits to patients with COPD (2B).
Although 6 to 12 weeks of pulmonary rehabilitation are associated with benefits in several outcomes, these decline gradually during 12 to 18 months (1A). However, some benefits, including health-related quality of life, are maintained above control levels at 12 to 18 months (1C).
Longer pulmonary rehabilitation programs (12 weeks) are associated with greater sustained benefits than are shorter programs (2C).
Maintenance strategies after pulmonary rehabilitation are associated with a modest improvement in long-term outcomes (2C).
Compared with lower extremity exercise training at lower intensity, higher exercise intensity is associated with greater physiologic improvement in patients with COPD (1B).
For patients with COPD, both low- and high-intensity exercise training produce clinical benefits (1A).
Adding a strength training component to a program of pulmonary rehabilitation increases both muscle strength and muscle mass (1A).
Routine use of anabolic agents in pulmonary rehabilitation for patients with COPD is not supported by current scientific evidence (2C).
In patients with COPD, unsupported endurance training of the upper extremities is beneficial and should be included in pulmonary rehabilitation programs (1A).
Routine use of inspiratory muscle training as an essential component of pulmonary rehabilitation is not supported by currently available scientific evidence (1B).
Education on collaborative self-management and prevention and treatment of exacerbations should be an integral component of pulmonary rehabilitation (1B).
Evidence to support the benefits of psychosocial interventions as a single therapeutic modality is minimal (2C).
Current practice and expert opinion support including psychosocial interventions as a component of comprehensive pulmonary rehabilitation programs for patients with COPD. However, scientific evidence is lacking, and therefore no recommendation is provided.
In patients with severe exercise-induced hypoxemia, supplemental oxygen should be used during rehabilitative exercise training (1C).
In patients without exercise-induced hypoxemia, administering supplemental oxygen during high-intensity exercise programs may improve gains in exercise endurance (2C).
In selected patients with severe COPD, noninvasive ventilation as an adjunct to exercise training produces modest additional improvements in exercise performance (2B).
Evidence is insufficient to support the routine use of nutritional supplementation in pulmonary rehabilitation of patients with COPD.
For some patients with chronic respiratory tract diseases other than COPD, pulmonary rehabilitation is beneficial (1B).
Current practice and expert opinion suggest that pulmonary rehabilitation for patients with chronic respiratory tract diseases other than COPD should be modified to include treatment strategies specific to individual diseases and patients, as well as treatment strategies common to both COPD and non-COPD patients. However, scientific evidence to support this recommendation is lacking.
The American Thoracic Society, The European Respiratory Society, the US COPD Coalition, and the AACVPR (by way of collaborating) have endorsed these clinical practice guidelines. The authors have disclosed no relevant financial relationships.

Chest. 2007;131:4S-42S.

Clinical Context
In the United States, COPD is the fourth leading cause of mortality, and mortality trends associated with COPD continue to increase. Mortality associated with COPD has grown faster among women than men, and more women in the United States die of COPD compared with men. In addition, COPD was responsible for 8 million visits to clinicians' offices and 726,000 hospital admissions across the United States in 2000.

Pulmonary rehabilitation appears to be a safe and effective means to treat COPD. The current guidelines from the ACCP and AACVPR update the 1997 guidelines for best practices for the use of pulmonary rehabilitation.

Study Highlights
An expert panel reviewed relevant data published between 1996 and 2004 to establish the current guidelines. MEDLINE and the Cochrane collection were the main databases searched. The initial search yielded 928 articles, and this group was culled to 81 studies in the establishment of the guidelines. Pulmonary rehabilitation has been demonstrated to improve dyspnea and health-related quality of life and to reduce the number of hospital days among patients with COPD. Pulmonary rehabilitation may also reduce the number of urgent and routine clinician visits. Research suggests that pulmonary rehabilitation is a cost-effective treatment of COPD. There is insufficient evidence to determine if pulmonary rehabilitation improves survival among patients with COPD. The authors suggest previous studies of this outcome might have been insufficiently powered to detect a significant difference. Pulmonary rehabilitation can improve depression and other psychosocial consequences of COPD. Most pulmonary rehabilitation programs have a formal component that lasts between 6 and 12 weeks. In general, these programs have been demonstrated to produce benefits that last between 12 and 18 months after the intervention but then gradually disappear with time. Some evidence suggests that the quality-of-life benefits of pulmonary rehabilitation may be longer lasting. There is no consensus on the optimal duration of pulmonary rehabilitation programs. Programs longer than 12 weeks can produce greater sustained benefits, particularly with regard to exercise tolerance, than shorter programs. Maintenance programs following intensive pulmonary rehabilitation may improve outcomes to a modest degree vs no follow-up program. The muscles of ambulation should be a focus of pulmonary rehabilitation. While high-intensity exercise training may produce greater physiologic benefits than low-intensity training, both types of training can produce clinical benefits for patients with COPD. Adding strength training to endurance training can improve muscle strength and muscle mass among patients with COPD. However, although anabolic agents can increase lean body mass among patients with COPD, there is insufficient evidence of their benefit to recommend their routine use in COPD. The routine use of inspiratory muscle training for COPD is not recommended, although this regimen may be considered for patients with poor inspiratory muscle strength and breathlessness despite medical therapy. While scientific knowledge regarding the efficacy of psychosocial interventions among patients with COPD is lacking, current clinical practice and expert opinion support these interventions as part of a larger program of pulmonary rehabilitation. Patients with severe exercise-induced hypoxemia should receive supplemental oxygen during exercise. Supplemental oxygen may also improve endurance among patients without exercise-induced hypoxemia. Noninvasive positive pressure ventilation can produce modest improvements in exercise performance during pulmonary rehabilitation.

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Jennie Stuart Medical Center
222 W. 18th St
Outpatient Pulmonary Services
Hopkinsville, KY 42240

July 24, 2007

Susan Harrison
Lead Analyst for NCA (CAG-00356N) for Pulmonary
Rehabilitation
Centers for Medicare and Medicaid Services

Tiffany Sanders, MD
Lead Medical Officer for NCA (CAG-00356N) for Pulmonary Rehabilitation
Centers for Medicare and Medicaid Services

Dear Ms. Harrison and Dr. Sanders:

This letter serves as a public comment on the Proposed Decision Memo for Pulmonary Rehabilitation (CAG-00356N). It is our understanding that CMS is seeking public comment on the appropriate frequency and duration of outpatient respiratory therapy services.

The attached document concurs with the Proposed Decision Memo definition of Pulmonary Rehabilitation as provided on an outpatient basis. The document also describes that CMS has established a precedent of providing coverage for outpatient pulmonary rehabilitation services based on the development of Local Coverage Determinations (LCDs) by the CMS contractors, the Fiscal Intermediaries. These LCDs have assisted hospitals in the successful defense of denied services being overturned at the Qualified Independent Contractor and Administrative Law Judge appeal levels. The Pulmonary Rehabilitation multidisciplinary model follows guidelines as set forth by the American Association of Cardiovascular and Pulmonary Rehabilitation as well at the NETT trial studies as defined by Medicare.

It is our hope that CMS will consider the enclosed information for consideration in the development of a national coverage policy for Pulmonary Rehabilitation Services.

Yours truly,

{LaTara Hopson}

{IAC}Definition of Pulmonary Rehabilitation

The stated accepted definition in the Proposed Decision Memo for Pulmonary Rehabilitation is:

Pulmonary Rehabilitation is an evidenced-based multidisciplinary and comprehensive intervention for patients with chronic respiratory diseases who are symptomatic and often have decreased daily life activities. Integrated into the individualized treatment of the patient, pulmonary rehabilitation is designed to reduce symptoms, optimize functional status, increase participation and reduce health care costs through stabilizing or reversing systemic manifestations of the disease.

Lack of Statutory Authority

Proposed Decision Memo:

CMS proposes that since the Social Security Act does not expressly define a comprehensive Pulmonary Rehabilitation Program as a part B Benefit, and the evidence is not adequate to draw conclusions on the benefit of individual components of pulmonary rehabilitation, we are not making any proposed national coverage determinations about these services at this time.

COMMENT:

CMS has established a precedent in the past for covering Pulmonary Rehabilitation Services.

In the Federal Register, November 1, 2001, CMS published three G-Codes allowing respiratory therapist to deliver services incident to a physician's service or in a provider setting such as an outpatient hospital or a comprehensive outpatient rehabilitation facility.

The availability of codes for services to improve respiratory function will make billing of CPT Codes 97000-97799 inappropriate for professionals involved in treating respiratory conditions, unless these services are delivered by physical and occupational therapy services.

Further clarification of these codes and the delivery of service were provided in the Federal Register/Vol. 67, No.251/Tuesday, December 31, 2002/Rules and Regulations.It is clear that CMS defined these codes to be used in a CORF, a physician office setting or a hospital outpatient department. CMS states in the Federal Register:

Since there is no respiratory therapy or pulmonary rehabilitation benefit, respiratory therapist can provide these services only in a CORF or under the 'incident to' provision in a physician's office or in the hospital outpatient setting.

It is stated in Federal Register/Vol. 67, No.251/Tuesday, December 31, 2002/Rules and Regulations in the clarification of Codes G0237, G0238, and G0239 when CMS responded:

.these codes are appropriate for use in the hospital outpatient setting. The 'NA' refers to the fact that in the hospital outpatient setting, these codes are paid under the hospital outpatient prospective payment system and are assigned to an APC, rather than being paid by the physician fee schedule.

Further:

We reiterate that Codes G0237, G0238, and G0239 were developed to provide more specificity about the services being delivered. Thus, CPT Codes 97000-97799 are not to be billed by professionals involved in treating respiratory conditions, unless these services are delivered by physical or occupational therapists and meet the other requirements for physical and occupational therapy services.

Another use of pulmonary rehabilitation and acknowledgement of CMS coverage and recognition of this service appears in the National Emphysema Treatment Trials and the resulting NCD:

1/240.1/ Lung Volume Reduction Surgery (Reduction Pneumoplasty) NCD: The surgery must be preceded and followed by a program of diagnostic and therapeutic services consistent with those provided in the NETT and designed to maximize the patient's potential to successfully undergo and recover from surgery. The program must include a 6 to 10 week series of at least 16, and no more than 20, preoperative sessions, each lasting a minimum of 2 hours. It must also include at least 6, and no more than 10, postoperative sessions, each lasting a minimum of 2 hours, within 8 to 9 weeks of the LVRS. This program must be consistent with the care plan developed by the treating physician following performance of a comprehensive evaluation of the patient's medical, psychosocial and nutritional needs, be consistent with the preoperative and postoperative services provided in the NETT, and arranged, monitored, and performed under the coordination of the facility where the surgery takes place.

CMS referencing 'of diagnostic and therapeutic services consistent with those provided in the NETT and designed to maximize the patient's potential to successfully undergo and recover from surgery' illustrates that CMS has recognized and covered Pulmonary Rehabilitation Services in the recent past. Further, CMS has acknowledged the use of a multi-disciplinary service billable in a hospital outpatient service. CMS states that all services must meet the test of being 'reasonable and necessary' pursuant to section 1862 (a) (1) (A) of the Act. Determinations of medical necessity have been made by carriers and intermediaries on a claim-by-claim basis in their local medical review policies. We believe that this is the appropriate manner to address these questions, and many of our contractors have already developed these policies.

The efficacy of the use of Pulmonary Rehabilitation in the NETT was published in the medical journal Chest as a clinical study, The Effects of Pulmonary Rehabilitation in the National Emphysema Treatment Trail, (Reis, et al; Chest/128/6/December 2006; pg(s) 3799-3809) which found that 'pulmonary rehabilitation in the NETT produced significant benefits for these patients with advanced emphysema'. (emphasis added) The consistency of the results, both in the NETT centers and at the satellite centers, demonstrates the effectiveness of rehabilitation in the management of patients with chronic lung diseases.''

The significance of this particular study is the fact that 'most trials have been conducted in single centers. The National Emphysema Treatment Trail (NETT) provided an opportunity to evaluate pulmonary rehabilitation in a large cohort of patients who were treated in centers throughout the United States' utilizing the same protocol.

Local Coverage Determination Policies (LCD) for Pulmonary Rehabilitation has been developed by CMS contractors. Payments have been made for the delivery of these services and have been upheld by Qualified Independent Contractor(s) (QIC) and Administrative Law Judge(s) (ALJ). It appears that the rulings favoring 'Pulmonary Rehabilitation' as defined in the LCD's establishes legal precedent and authority for CMS to convey an NCD for these services.

Finally, it is these LCD's and the NCD for Lung Volume Reduction that establishes the service structure and frequency and duration for pulmonary rehabilitation as:

I have several comments related to the CMS proposed decision.

1- issue of societal vs expert input: I have been intricately involved in several important documents regarding pulmonary rehabilitation through the ATS and AACVPR. These position papers and program guidelines are written by experts in the field and reviewed by independent experts in the field. Therefore, it is unclear to me and seemingly incorrect to separate societal input from expert opinion. I regret that most of us did not comment individually during the initial process, however, we assumed that this was clear and our expert opinions and scientific evidence were well laid out in these clearly referenced and easily obtained documents.

2-It should be noted that the initial sentence of the CMS report refers to the 1999 ATS statement on PR. As you know, there is a very recent update (ATS/ERS Statement on PR from June 06) as well as a most recent update of the ACCCP/AACVPR evidence based guidelines in 5-07. Both of these documents unequivocally show the benefits of PR in multiple settings using very standardized outcome measures in the domains of exercise capacity, functional performance and health-related quality of life. In addition, there are several studies showing a cost benefit. All these issues are covered in depth in both documents, but we would be happy to elaborate at your discretion. It also should be noted that unlike many other areas of clinical medicine- there is almost uniform consensus on the benefits and scientific evidence for PR-hence recommendations for comprehensive pulmonary rehabilitation (not simply excercise or education) are found in the current ATS/ERS guidelines for treatment of COPD and the GOLD guidelines.

3- I strongly disagree with the comments made regarding lack of evidence or uniformity in program make-up and outcome assessment. Despite the fact that a major tenant of PR is individualized care, thus programs may be altered due to pt's underlying disease and/or individual needs and goals, they adhere to quite consistently in length, timing, education topics and outcomes measured. These outcome assessments are well standardized and required for most program certification and institiutional oversight.

4-Inspiratory muscle training is not a major focus or component of PR and this is clearly stated in all documents.

5-"neither is there a benefit category for the combination of services that make up pulmonary rehab" follows the statement "did not find evidence of benefit when the services with a benefit category are provided independently." This seems like a Catch 22 argument: 1) there's a large body of evidence that comprehensive pulmonary rehab is beneficial, but there is no benefit category for this; 2) CMS does have a benefit category for individual services but that is not how rehab is provided or, appropriately, how clinical trials have been done so there is not sufficient evidence. Therefore, it seems that no matter how much scientific evidence or expert opinion we provide, there is no solution to this quandry.In conclusion: The CMS document nicely reviews a plethora of scientific evidence for pulmonary rehab based on external and internal tech assessments, RCTs, evidence-based guidelines and professional society position statements. However, there seems to be a very worrisome disconnect between the overwhelming body of evidence and the conclusions that CMS can't justify paying for a well-established benefit without a specific mandate in the statute. I hope that CMS will reconsider this decision. I am available for any assitance that you require.

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Definition of Pulmonary Rehabilitation

The stated accepted definition in the Proposed Decision Memo for Pulmonary Rehabilitation is:

Pulmonary Rehabilitation is an evidenced-based multidisciplinary and comprehensive intervention for patients with chronic respiratory diseases who are symptomatic and often have decreased daily life activities. Integrated into the individualized treatment of the patient, pulmonary rehabilitation is designed to reduce symptoms, optimize functional status, increase participation and reduce health care costs through stabilizing or reversing systemic manifestations of the disease.

Lack of Statutory Authority

Proposed Decision Memo:

CMS proposes that since the Social Security Act does not expressly define a comprehensive Pulmonary Rehabilitation Program as a part B Benefit, and the evidence is not adequate to draw conclusions on the benefit of individual components of pulmonary rehabilitation, we are not making any proposed national coverage determinations about these services at this time.

COMMENT:

CMS has established a precedent in the past for covering Pulmonary Rehabilitation Services.

In the Federal Register, November 1, 2001, CMS published three G-Codes allowing respiratory therapist to deliver services incident to a physician's service or in a provider setting such as an outpatient hospital or a comprehensive outpatient rehabilitation facility.

The availability of codes for services to improve respiratory function will make billing of CPT Codes 97000-97799 inappropriate for professionals involved in treating respiratory conditions, unless these services are delivered by physical and occupational therapy services.

Further clarification of these codes and the delivery of service were provided in the Federal Register/Vol. 67, No.251/Tuesday, December 31, 2002/Rules and Regulations.It is clear that CMS defined these codes to be used in a CORF, a physician office setting or a hospital outpatient department. CMS states in the Federal Register:

Since there is no respiratory therapy or pulmonary rehabilitation benefit, respiratory therapist can provide these services only in a CORF or under the 'incident to' provision in a physician's office or in the hospital outpatient setting.

It is stated in Federal Register/Vol. 67, No.251/Tuesday, December 31, 2002/Rules and Regulations in the clarification of Codes G0237, G0238, and G0239 when CMS responded:

'.these codes are appropriate for use in the hospital outpatient setting. The 'NA' refers to the fact that in the hospital outpatient setting, these codes are paid under the hospital outpatient prospective payment system and are assigned to an APC, rather than being paid by the physician fee schedule.

Further:

We reiterate that Codes G0237, G0238, and G0239 were developed to provide more specificity about the services being delivered. Thus, CPT Codes 97000-97799 are not to be billed by professionals involved in treating respiratory conditions, unless these services are delivered by physical or occupational therapists and meet the other requirements for physical and occupational therapy services.

Another use of pulmonary rehabilitation and acknowledgement of CMS coverage and recognition of this service appears in the National Emphysema Treatment Trials and the resulting NCD:

1/240.1/ Lung Volume Reduction Surgery (Reduction Pneumoplasty) NCD: The surgery must be preceded and followed by a program of diagnostic and therapeutic services consistent with those provided in the NETT and designed to maximize the patient's potential to successfully undergo and recover from surgery. The program must include a 6 to 10 week series of at least 16, and no more than 20, preoperative sessions, each lasting a minimum of 2 hours. It must also include at least 6, and no more than 10, postoperative sessions, each lasting a minimum of 2 hours, within 8 to 9 weeks of the LVRS. This program must be consistent with the care plan developed by the treating physician following performance of a comprehensive evaluation of the patient's medical, psychosocial and nutritional needs, be consistent with the preoperative and postoperative services provided in the NETT, and arranged, monitored, and performed under the coordination of the facility where the surgery takes place.

CMS referencing 'of diagnostic and therapeutic services consistent with those provided in the NETT and designed to maximize the patient's potential to successfully undergo and recover from surgery' illustrates that CMS has recognized and covered Pulmonary Rehabilitation Services in the recent past. Further, CMS has acknowledged the use of a multi-disciplinary service billable in a hospital outpatient service. CMS states that all services must meet the test of being 'reasonable and necessary' pursuant to section 1862 (a) (1) (A) of the Act. Determinations of medical necessity have been made by carriers and intermediaries on a claim-by-claim basis in their local medical review policies. We believe that this is the appropriate manner to address these questions, and many of our contractors have already developed these policies.

The efficacy of the use of Pulmonary Rehabilitation in the NETT was published in the medical journal Chest as a clinical study, The Effects of Pulmonary Rehabilitation in the National Emphysema Treatment Trail, (Reis, et al; Chest/128/6/December 2006; pg(s) 3799-3809) which found that 'pulmonary rehabilitation in the NETT produced significant benefits for these patients with advanced emphysema'. (emphasis added) The consistency of the results, both in the NETT centers and at the satellite centers, demonstrates the effectiveness of rehabilitation in the management of patients with chronic lung diseases.'

The significance of this particular study is the fact that 'most trials have been conducted in single centers. The National Emphysema Treatment Trail (NETT) provided an opportunity to evaluate pulmonary rehabilitation in a large cohort of patients who were treated in centers throughout the United States' utilizing the same protocol.

Local Coverage Determination Policies (LCD) for Pulmonary Rehabilitation has been developed by CMS contractors. Payments have been made for the delivery of these services and have been upheld by Qualified Independent Contractor(s) (QIC) and Administrative Law Judge(s) (ALJ). It appears that the rulings favoring 'Pulmonary Rehabilitation' as defined in the LCD's establishes legal precedent and authority for CMS to convey an NCD for these services.

Finally, it is these LCD's and the NCD for Lung Volume Reduction that establishes the service structure and frequency and duration for pulmonary rehabilitation as:

July 26, 2007

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Mail stop # C1-09-06
Baltimore, MD 21244

RE: Proposed Decision Memo for Pulmonary Rehabilitation (CAG-00356N)

Dear Dr. Phurrough:

On behalf of the American Physical Therapy Association (APTA), which represents over 70,000 physical therapists, physical therapist assistants, and students of physical therapy, I would like to provide comments on the Proposed Decision Memo for Pulmonary Rehabilitation (CAG-00356N). We applaud the efforts of the Centers for Medicare and Medicaid Services (CMS) to provide comprehensive and quality care to Medicare beneficiaries, and we would like to thank the agency for its well reasoned rationale as presented in this proposed decision memorandum.

While we appreciate CMS's thorough discussion regarding coverage of pulmonary rehabilitation, we are concerned that this decision could be misinterpreted by Medicare contractors as an indication that they should rescind current local coverage policies that enable Medicare beneficiaries to obtain essential pulmonary rehabilitation services provided by physical therapists. Therefore, we believe it is essential for CMS to make clear in its final decision memorandum that Medicare contractors should not eliminate existing policies that provide coverage for these critical services.

We ask that you take the following into consideration.

Ensuring Access and Coverage to Physical Therapy Services for Pulmonary Rehabilitation Patients

In the memorandum, CMS 'proposes that since the Social Security Act does not expressly define a comprehensive Pulmonary Rehabilitation Program as a Part B benefit, and that the evidence is not adequate to draw conclusions on the benefit of individual components of pulmonary rehabilitation, [the Agency] is not making any proposed national coverage determinations about these services at this time.'

As we stated in our January 26 comments to the National Coverage Analyses inquiry, we would like to emphasize the importance of physical therapy to patients with Chronic Obstructive Pulmonary Disease (COPD) and other pulmonary disorders. It is of paramount importance that Medicare reimbursement policy on pulmonary rehabilitation not be mirrored after the 'incident too' provisions as contained in the Cardiac Rehabilitation NCD. Physical therapists are competent, skilled, and experienced professionals in treating patients with cardiovascular and pulmonary disorders, and should continue to treat these patients independent of direct physician supervision.

We strongly recommend that CMS clearly state in its final decision memo that this pulmonary rehabilitation coverage policy determination does not in any manner inhibit Medicare beneficiaries access to and coverage of physical therapy services as established under the Social Security Act § 1861 (p) when being treated for COPD or other pulmonary disorders.

We recognize that CMS states in the proposed decision memo that, 'There may be a benefit category for therapeutic exercise under certain circumstances. For instance, therapeutic exercise may be considered to be a benefit under section 1861(p) of the Act as a physical therapy services.' However, there a number of other services offered under the physical therapy benefit that are frequently delivered to patients with COPD and other pulmonary disorders besides therapeutic exercise that fall under the physical therapy benefit.

Physical therapy is integral to the treatment and care of patients with COPD and other pulmonary disorders. Following an extensive examination of the patient, physical therapists develop appropriate plans of care and provide individualized exercise techniques that promote increased functionality for patients in their home and community environment.

Medical Necessity of Pulmonary Rehabilitation Services Pursuant to § 1862(1) of the Social Security Act

The Social Security Act §1862(1) states in part, 'payment may not be made under [Medicare] part A or part B for any expenses incurred for items or services 'which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.'

Specifically the Medicare Benefits Policy Manual states:

In your literature I do not find reference to the Chest, May, 2007 Supplement PULMONARY REHABILITATION: Joint ACCP/AACVPR Evidence-Based Clinical Practice Guidelines. I have therefore attached this document to my comments.

This document did address the duration of Pulmonary Rehab: On page 13S. #8 - Six to twelve weeks of pulmonary rehabilitation produces benefits in several outcomes that decline gradually over 12 to 18 months. (Grade recommendation 1A - strong recommendation) From the patient's perspective, the optimal duration should be that which produces maximal effects in the individual without becoming burdensome. This has been the standard of practice for my pulmonary rehab program. Our LCD allows up to 30 visits. We address time frame of pulmonary rehab services individualized to patient's strength and endurance level.

Pulmonary Rehabilitation also is beneficial for patients with restrictive disease. I have attached a study my facility participated in. It was published in September/October 2002; Journal of Cardiopulmonary Rehabilitation. Outcomes Analysis in Patients with Restrictive Lung Disease completing a Pulmonary Rehabilitation Program. The conclusion derived showed of the twenty-four patients with restrictive lung disease who had completed an individualized outpatient pulmonary rehabilitation program based on the AACVPR guidelines. Fifty-five outcomes parameters were evaluated. The parameters were a combination of physiological, physical, and quality of life measurements. Data was collected at entry into and exit from the program. Twenty- six outcomes demonstrated statistically significant improvement from entry to exit. No outcomes showed worsening. Subgroups of 14 outcomes were considered to be clinically significant. I have also included these in my attachments.

Pulmonary Rehab is especially important for pre lung transplant patients. This allows patients to become stronger and improve their endurance, to better tolerate the post-operative course.

Lastly I would like to comment on the information in your document on page 12 of 14 which notes 'CMS found strong evidence to conclude that exercise-based PR is effective in improving the patients' disease-specific QoL, as well as their functional and maximal exercise capacity'? Therefore, the evidence is adequate to conclude that pulmonary rehabilitation improves health outcomes for persons with GOLD classification II or III (moderate or severe) COPD in ambulatory settings. The guidelines for qualifying for outpatient pulmonary rehab in my area require Pulmonary Function Tests results showing the FEV1.0 or FVC to be less than 60% of predicted. These guidelines allow only a small portion of the Stage II, Moderate COPD clients to participate in pulmonary rehab, which could allow improved outcomes to this class of patients.

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Would you throw a drowning man a life preserver? Feed a starving Human being...deny a chance to live to a mother or child. Pulmonary Rehabilitation is a proven, effective method to preserve and enhance the life and quality of life for a person afflicted with COPD. Please, do not deny the thousands of American citizens with COPD, the right to a better life. I have personally seen the POSITIVE results effects upon the life style and ability to function independently of several individuals who have been fortunate enough to have been through REHAB. It would be TRAGIC if people were deprived of the chance to live because they were denied this chance. It's a win, win situation. improving and maintaining function... will keep people independent.. and out of.. Expensive nursing homes and/or extended hospital stays. Jesse Soper

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It has been my experience with Pulmonary Rehab since starting our program 4 years ago that the benefits to the patients can be measured by the quality of life surveys completed at the beginning and end of the program, 6 minute walk tests both pre and post, as well as spirometry results pre and post. Patients themselves will tell you the benefits to their physical as well as emotional health. We've had families thank us for giving them their life back, patients go from wheelchair bound to canes, patients go from homebound to productive members of society. To guage those things may be difficult in quantitative, but not qualitative research studies; you have to listen to the patients. We have found it difficult to get the pulmonary patients to attend more than 2 days per week and as a result the majority only come twice; however they still are benefiting. We make sure they are keeping up their "homework" and reinforce what they are doing at home while continuing to add to it. The thought of this no longer being a covered service is a repulsive injustice to the many that have been given quality back into their remaining years that may or may not have been extending by the increased functional capacity gained during the exercise of rehab.

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{Fairmont General Hospital
1325 Locust Ave
Fairmont, WV 26554}

July 24, 2007

Susan Harrison
Lead Analyst for NCA (CAG-00356N) for Pulmonary
Rehabilitation
Centers for Medicare and Medicaid Services

Tiffany Sanders, MD
Lead Medical Officer for NCA (CAG-00356N) for
Pulmonary Rehabilitation
Centers for Medicare and Medicaid Services

Dear Ms. Harrison and Dr. Sanders:

This letter serves as a public comment on the Proposed Decision Memo for Pulmonary Rehabilitation (CAG-00356N). It is our understanding that CMS is seeking public comment on the appropriate frequency and duration of outpatient respiratory therapy services.

The attached document concurs with the Proposed Decision Memo definition of Pulmonary Rehabilitation as provided on an outpatient basis. The document also describes that CMS has established a precedent of providing coverage for outpatient pulmonary rehabilitation services based on the development of Local Coverage Determinations (LCDs) by the CMS contractors, the Fiscal Intermediaries. These LCDs have assisted hospitals in the successful defense of denied services being overturned at the Qualified Independent Contractor and Administrative Law Judge appeal levels. The Pulmonary Rehabilitation multidisciplinary model follows guidelines as set forth by the American Association of Cardiovascular and Pulmonary Rehabilitation as well at the NETT trial studies as defined by Medicare.

It is our hope that CMS will consider the enclosed information for consideration in the development of a national coverage policy for Pulmonary Rehabilitation Services.

Yours truly,

{Kelly McCoy} {Regional Director of Business Dev.}
Definition of Pulmonary Rehabilitation

The stated accepted definition in the Proposed Decision Memo for Pulmonary Rehabilitation is:

Pulmonary Rehabilitation is an evidenced-based multidisciplinary and comprehensive intervention for patients with chronic respiratory diseases who are symptomatic and often have decreased daily life activities. Integrated into the individualized treatment of the patient, pulmonary rehabilitation is designed to reduce symptoms, optimize functional status, increase participation and reduce health care costs through stabilizing or reversing systemic manifestations of the disease.

Lack of Statutory Authority

Proposed Decision Memo:

CMS proposes that since the Social Security Act does not expressly define a comprehensive Pulmonary Rehabilitation Program as a part B Benefit, and the evidence is not adequate to draw conclusions on the benefit of individual components of pulmonary rehabilitation, we are not making any proposed national coverage determinations about these services at this time.

COMMENT:

CMS has established a precedent in the past for covering Pulmonary Rehabilitation Services.

In the Federal Register, November 1, 2001, CMS published three G-Codes allowing respiratory therapist to deliver services incident to a physician's service or in a provider setting such as an outpatient hospital or a comprehensive outpatient rehabilitation facility.

The availability of codes for services to improve respiratory function will make billing of CPT Codes 97000-97799 inappropriate for professionals involved in treating respiratory conditions, unless these services are delivered by physical and occupational therapy services.

Further clarification of these codes and the delivery of service were provided in the Federal Register/Vol. 67, No.251/Tuesday, December 31, 2002/Rules and Regulations.It is clear that CMS defined these codes to be used in a CORF, a physician office setting or a hospital outpatient department. CMS states in the Federal Register:

Since there is no respiratory therapy or pulmonary rehabilitation benefit, respiratory therapist can provide these services only in a CORF or under the 'incident to' provision in a physician's office or in the hospital outpatient setting.

It is stated in Federal Register/Vol. 67, No.251/Tuesday, December 31, 2002/Rules and Regulations in the clarification of Codes G0237, G0238, and G0239 when CMS responded:

.these codes are appropriate for use in the hospital outpatient setting. The 'NAA' refers to the fact that in the hospital outpatient setting, these codes are paid under the hospital outpatient prospective payment system and are assigned to an APC, rather than being paid by the physician fee schedule.

Further:

We reiterate that Codes G0237, G0238, and G0239 were developed to provide more specificity about the services being delivered. Thus, CPT Codes 97000-97799 are not to be billed by professionals involved in treating respiratory conditions, unless these services are delivered by physical or occupational therapists and meet the other requirements for physical and occupational therapy services.

Another use of pulmonary rehabilitation and acknowledgement of CMS coverage and recognition of this service appears in the National Emphysema Treatment Trials and the resulting NCD:

1/240.1/ Lung Volume Reduction Surgery (Reduction Pneumoplasty) NCD: The surgery must be preceded and followed by a program of diagnostic and therapeutic services consistent with those provided in the NETT and designed to maximize the patient's potential to successfully undergo and recover from surgery. The program must include a 6 to 10 week series of at least 16, and no more than 20, preoperative sessions, each lasting a minimum of 2 hours. It must also include at least 6, and no more than 10, postoperative sessions, each lasting a minimum of 2 hours, within 8 to 9 weeks of the LVRS. This program must be consistent with the care plan developed by the treating physician following performance of a comprehensive evaluation of the patient's medical, psychosocial and nutritional needs, be consistent with the preoperative and postoperative services provided in the NETT, and arranged, monitored, and performed under the coordination of the facility where the surgery takes place.

CMS referencing 'of diagnostic and therapeutic services consistent with those provided in the NETT and designed to maximize the patient's potential to successfully undergo and recover from surgery' illustrates that CMS has recognized and covered Pulmonary Rehabilitation Services in the recent past. Further, CMS has acknowledged the use of a multi-disciplinary service billable in a hospital outpatient service. CMS states that all services must meet the test of being 'reasonable and necessary' pursuant to section 1862 (a) (1) (A) of the Act. Determinations of medical necessity have been made by carriers and intermediaries on a claim-by-claim basis in their local medical review policies. We believe that this is the appropriate manner to address these questions, and many of our contractors have already developed these policies.

The efficacy of the use of Pulmonary Rehabilitation in the NETT was published in the medical journal Chest as a clinical study, The Effects of Pulmonary Rehabilitation in the National Emphysema Treatment Trail, (Reis, et al; Chest/128/6/December 2006; pg(s) 3799-3809) which found that 'pulmonary rehabilitation in the NETT produced significant benefits for these patients with advanced emphysema'. (emphasis added) The consistency of the results, both in the NETT centers and at the satellite centers, demonstrates the effectiveness of rehabilitation in the management of patients with chronic lung diseases.'

The significance of this particular study is the fact that 'most trials have been conducted in single centers. The National Emphysema Treatment Trail (NETT) provided an opportunity to evaluate pulmonary rehabilitation in a large cohort of patients who were treated in centers throughout the United States' utilizing the same protocol.

Local Coverage Determination Policies (LCD) for Pulmonary Rehabilitation has been developed by CMS contractors. Payments have been made for the delivery of these services and have been upheld by Qualified Independent Contractor(s) (QIC) and Administrative Law Judge(s) (ALJ). It appears that the rulings favoring 'Pulmonary Rehabilitation' as defined in the LCD's establishes legal precedent and authority for CMS to convey an NCD for these services.

Finally, it is these LCD's and the NCD for Lung Volume Reduction that establishes the service structure and frequency and duration for pulmonary rehabilitation as:

To: Steve E. Phurrough, MD, MPA,
Director, Coverage and Analysis Group

Re: Proposed Decision Memo for Pulmonary Rehabilitation (CAG-00356N)

The American Association for Respiratory Care (AARC), an association of over 43,000 respiratory therapists, respectfully submits the following comments on the proposed decision memo regarding pulmonary rehabilitation.

Comment:

The AARC concurs with CMS' assessment that the respiratory therapy services covered in a CORF setting are consistent with the evidentiary findings regarding pulmonary rehabilitation as a reasonable and necessary service under the Medicare statute. However, we are disappointed that CMS has determined that such evidentiary findings are inadequate to draw conclusions on the benefit of individual components of pulmonary rehabilitation in other outpatient settings.

CMS bases its decision not to issue a national coverage determination for pulmonary rehabilitation, in part, based on the fact that there is no current Part B benefit category for pulmonary rehabilitation under the Medicare statute. The AARC believes that Congress will soon revise the Social Security statute and add outpatient pulmonary rehabilitation as a Medicare benefit. At that time, we would expect CMS to issue expeditiously a clear and concise national policy for outpatient pulmonary rehabilitation through its formal rulemaking process.

The AARC continues to assert, as we have for nearly 20 years, that the components of pulmonary rehabilitation, including assessment, therapeutics and diagnostics are covered, when medically necessary, under the Medicare Part B program.

We maintain that the efficacy and cost effectiveness of pulmonary rehabilitation has been well documented. Further, the patchwork of inconsistent Medicare Local Coverage Determinations (LCDs) is patently unfair to the Medicare beneficiary. For example, some Regions will cover pulmonary rehabilitation services and other areas of the country would deny the same beneficiary with the same diagnosis these same rehabilitation services. For this reason alone, we believe CMS should have issued a national coverage policy. Clearly, a precedent has been set since there are some LCDs that recognize this important set of clinical services. We note, however, that CMS did not take into consideration these LCDs and the clinical evidence upon which they were based in reviewing the merits of a national coverage determination for pulmonary rehabilitation.

Comment:

The frequency and duration of pulmonary rehabilitation services performed by the respiratory therapist varies from patient-to-patient since the plan of care is a dynamic document tailored for each patient. There are, however, typical timeframes and frequencies for certain activities which the AARC has outlined below. To collect specific data that may be useful to CMS would require a survey of our membership which cannot be completed prior to the close of the comment period.

In the AARC's previous comments on the national coverage determination for pulmonary rehabilitation submitted in January of this year, we provided an overview of the range of clinical services the respiratory therapist can provide under a physician-ordered pulmonary rehabilitation plan of care. These include patient assessment, disease management and exercise supervision. Also, as noted previously, the respiratory therapist is the only allied health professional specifically educated and competency tested in all aspects of respiratory and pulmonary care.

Pulmonary Rehabilitation Services Furnished by Respiratory Therapists in CORFs

Pulmonary rehabilitation services based on the AACVPR guidelines for pulmonary rehabilitation and the most recently published article by the ACCP/AACVPR (copies of which CMS has received previously) state that pulmonary rehabilitation services should last between 6-12 weeks, or 24-36 sessions. In its latest review to determine the feasibility of a national coverage determination (NCD) for pulmonary rehabilitation, CMS looked at the respiratory therapy services performed in the CORF setting and asked for comments specifically on the frequency and duration of those services.

With respect to those services identified in 42 CFR §410.100(e)(1) to 2(vi), the following are furnished as part of every pulmonary rehabilitation session:

I have completely read your decision, I feel that you don't have an understanding of the scope of the problem or of the cost savings to every tax payer. If a person with lung or heart disease goes through and completes a rehabilitation program they have signiificant improvement in their quality of life. Most will also improve physically. Sure some do not, but every test that is given, even for those with no improvement shows their mental status much improved post rehabilitation. Then you have the savings of less emergency visits, less hospitalization, with adds up to less of a drain on the medicare system. These are seen with every rehab. It is important to the livelihood of your patients that you cover to give pulmonary rehabilitation a coverage determination.

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I would like to strongly support legislative coverage for pulmonary medical problems, especially Chronic Obstructive Pulmonary Disease (COPD) diagnosis, treatment, and rehabilitation therapy coverage. The current law is not specific enough to cover the needs of patients with COPD and legislation should include complete coverage for this major need.

I have practiced medicine for 43 years and I am an emeritus clinical professor of medicine at the University of California, San Francisco, Medical School and an adjunct professor at Stanford Medical School and have written over 50 medical articles and 21 books on the subject of cancer patient treatment and care (recent book "Everyone's Guide for Cancer Supportive Care"). It is clear that one of the critical issues in supportive care is breathing in patients with COPD, as patients cannot breathe when they exert themselves and, therefore, have a poor quality of life. Treatment clearly lessens this disability.

Without complete medical care, which includes diagnosis, treatment, and rehabilitation following treatment, a patient's chance of sustaining any qualify of life is poor and probably non-existent.

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DePaul Medical Center
150 Kingsley Lane
Norfolk, VA 23505

July 24, 2007

Susan Harrison
Lead Analyst for NCA (CAG-00356N) for Pulmonary Rehabilitation
Centers for Medicare and Medicaid Services

Tiffany Sanders, MD
Lead Medical Officer for NCA (CAG-00356N) for Pulmonary Rehabilitation
Centers for Medicare and Medicaid Services

Dear Ms. Harrison and Dr. Sanders:

This letter serves as a public comment on the Proposed Decision Memo for Pulmonary Rehabilitation (CAG-00356N). It is our understanding that CMS is seeking public comment on the appropriate frequency and duration of outpatient respiratory therapy services.

The attached document concurs with the Proposed Decision Memo definition of Pulmonary Rehabilitation as provided on an outpatient basis. The document also describes that CMS has established a precedent of providing coverage for outpatient pulmonary rehabilitation services based on the development of Local Coverage Determinations (LCDs) by the CMS contractors, the Fiscal Intermediaries. These LCDs have assisted hospitals in the successful defense of denied services being overturned at the Qualified Independent Contractor and Administrative Law Judge appeal levels. The Pulmonary Rehabilitation multidisciplinary model follows guidelines as set forth by the American Association of Cardiovascular and Pulmonary Rehabilitation as well at the NETT trial studies as defined by Medicare.

It is our hope that CMS will consider the enclosed information for consideration in the development of a national coverage policy for Pulmonary Rehabilitation Services.

Yours truly,

Trey Steckline
Regional Director

Definition of Pulmonary Rehabilitation

The stated accepted definition in the Proposed Decision Memo for Pulmonary Rehabilitation is:

Pulmonary Rehabilitation is an evidenced-based multidisciplinary and comprehensive intervention for patients with chronic respiratory diseases who are symptomatic and often have decreased daily life activities. Integrated into the individualized treatment of the patient, pulmonary rehabilitation is designed to reduce symptoms, optimize functional status, increase participation and reduce health care costs through stabilizing or reversing systemic manifestations of the disease.

Lack of Statutory Authority

Proposed Decision Memo:

CMS proposes that since the Social Security Act does not expressly define a comprehensive Pulmonary Rehabilitation Program as a part B Benefit, and the evidence is not adequate to draw conclusions on the benefit of individual components of pulmonary rehabilitation, we are not making any proposed national coverage determinations about these services at this time.

COMMENT:

CMS has established a precedent in the past for covering Pulmonary Rehabilitation Services.

In the Federal Register, November 1, 2001, CMS published three G-Codes allowing respiratory therapist to deliver services incident to a physician's service or in a provider setting such as an outpatient hospital or a comprehensive outpatient rehabilitation facility.

The availability of codes for services to improve respiratory function will make billing of CPT Codes 97000-97799 inappropriate for professionals involved in treating respiratory conditions, unless these services are delivered by physical and occupational therapy services.

Further clarification of these codes and the delivery of service were provided in the Federal Register/Vol. 67, No.251/Tuesday, December 31, 2002/Rules and Regulations.It is clear that CMS defined these codes to be used in a CORF, a physician office setting or a hospital outpatient department. CMS states in the Federal Register:

Since there is no respiratory therapy or pulmonary rehabilitation benefit, respiratory therapist can provide these services only in a CORF or under the 'incident to' provision in a physician's office or in the hospital outpatient setting.

It is stated in Federal Register/Vol. 67, No.251/Tuesday, December 31, 2002/Rules and Regulations in the clarification of Codes G0237, G0238, and G0239 when CMS responded:

.these codes are appropriate for use in the hospital outpatient setting. The 'NAA' refers to the fact that in the hospital outpatient setting, these codes are paid under the hospital outpatient prospective payment system and are assigned to an APC, rather than being paid by the physician fee schedule.

Further:

We reiterate that Codes G0237, G0238, and G0239 were developed to provide more specificity about the services being delivered. Thus, CPT Codes 97000-97799 are not to be billed by professionals involved in treating respiratory conditions, unless these services are delivered by physical or occupational therapists and meet the other requirements for physical and occupational therapy services.

Another use of pulmonary rehabilitation and acknowledgement of CMS coverage and recognition of this service appears in the National Emphysema Treatment Trials and the resulting NCD:

1/240.1/ Lung Volume Reduction Surgery (Reduction Pneumoplasty) NCD: The surgery must be preceded and followed by a program of diagnostic and therapeutic services consistent with those provided in the NETT and designed to maximize the patient's potential to successfully undergo and recover from surgery. The program must include a 6 to 10 week series of at least 16, and no more than 20, preoperative sessions, each lasting a minimum of 2 hours. It must also include at least 6, and no more than 10, postoperative sessions, each lasting a minimum of 2 hours, within 8 to 9 weeks of the LVRS. This program must be consistent with the care plan developed by the treating physician following performance of a comprehensive evaluation of the patient's medical, psychosocial and nutritional needs, be consistent with the preoperative and postoperative services provided in the NETT, and arranged, monitored, and performed under the coordination of the facility where the surgery takes place.

CMS referencing 'of diagnostic and therapeutic services consistent with those provided in the NETT and designed to maximize the patient's potential to successfully undergo and recover from surgery' illustrates that CMS has recognized and covered Pulmonary Rehabilitation Services in the recent past. Further, CMS has acknowledged the use of a multi-disciplinary service billable in a hospital outpatient service. CMS states that all services must meet the test of being 'reasonable and necessary' pursuant to section 1862 (a) (1) (A) of the Act. Determinations of medical necessity have been made by carriers and intermediaries on a claim-by-claim basis in their local medical review policies. We believe that this is the appropriate manner to address these questions, and many of our contractors have already developed these policies.

The efficacy of the use of Pulmonary Rehabilitation in the NETT was published in the medical journal Chest as a clinical study, The Effects of Pulmonary Rehabilitation in the National Emphysema Treatment Trail, (Reis, et al; Chest/128/6/December 2006; pg(s) 3799-3809) which found that 'pulmonary rehabilitation in the NETT produced significant benefits for these patients with advanced emphysema'. (emphasis added) The consistency of the results, both in the NETT centers and at the satellite centers, demonstrates the effectiveness of rehabilitation in the management of patients with chronic lung diseases.'

The significance of this particular study is the fact that 'most trials have been conducted in single centers. The National Emphysema Treatment Trail (NETT) provided an opportunity to evaluate pulmonary rehabilitation in a large cohort of patients who were treated in centers throughout the United States' utilizing the same protocol.

Local Coverage Determination Policies (LCD) for Pulmonary Rehabilitation has been developed by CMS contractors. Payments have been made for the delivery of these services and have been upheld by Qualified Independent Contractor(s) (QIC) and Administrative Law Judge(s) (ALJ). It appears that the rulings favoring 'Pulmonary Rehabilitation' as defined in the LCD's establishes legal precedent and authority for CMS to convey an NCD for these services.

Finally, it is these LCD's and the NCD for Lung Volume Reduction that establishes the service structure and frequency and duration for pulmonary rehabilitation as:

I have started up two Pulmonary Rehab programs at two different institutes. I have seen great results in patient's knowledge of their lung disease and their every day living. I had one patient who quit smoking due the support of rehab program and the better understanding of his lungs and what smoking was doing to them. He even starting driving again and began living again. He told his pulmonologist that the program saved his life. I would say probably about 85% of the rehab patients continue their exercise program well after they leave the program. These people just need to be shown that they can exercise and be provided with guidance until their confidence comes back. I can not believe that the government can not see the validity of this program.

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Pulmonary Rehabilitation has been shown in many studies to be a very important factor in the treatment of people with COPD (Chronic Obstrrucive Lung Disease). It improves the quality of their life, decreases the sensation of shortness of breath, and helps them carry out the activities of daily living through the strengthening of muscles, just to name a few. It is very unfair for Medicare to pay for pulmonary rehabilitation in some states and not others. Please, rewrite your regulations so that there is UNIFORM coverage of this important treatment option in ALL states. Thank you.

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Pulmonary Rehabilitation is often difficult to define in terms of evidence based studies since the overall benefits are not typically measured outcomes like FVC and FEV1 results determined by Pulmonary Function Studies. Pulmonary Rehab should be evaluated as a result of outcomes generated by quality of life issues concerning the patient directly. Lung function is not going to improve for example like the ejection fraction does in instances of cardiac rehabilitation. As a respiratory therapist involved in both cardiac and pulmonary rehab, I have seen the improvement from both disease processes and yes while cardiac improvement is much more measurable pulmonary patients are generally the "sicker" of the two. They are much more limited due to the shortness of breath and require more attention focusing on improvement of daily activites (ADL's) such as bathing, dressing, cooking, etc rather than "aerobic" exercise. Patients with pulmonary disease need more psychological support along with specific education concerning diet, breathing retraining, and management of disease process. While pulmonary rehab patients in my experience do not excel to the measurable levels that cardiac patients typically benefit to, there are usually noted improvements in ADL's that the patient is able to perform. We conduct a pre and post survey of shortness of breath with daily activities of living (ADL's) and have patients rate from no shortness of breath to severe and document improvements noted by patient. While this is based on patient description, this tool does help to show patient perceived outcomes in shortness of breath levels. Documentation of oxygen levels along with dyspnea and percieved effort ratings with exercise can also show positive outcomes. While treatment options are limited for COPD and other pulmonary illnesses, pulmonary rehab should be an intrical part of the treatment regimen due to benefits in the quality of life of pulmonary patients. A quality of socialization that the program promotes is also a measurable outcome as percieved by the patient. Pulmonary patients due to their limitations and shortness of breath may tend to not participate in any activites therefore becoming even more limited in ADL's. Pulmonary Rehab teaches patients the importance of staying active, learning about their disease process, and beginning some form of exercise for strengthing. Studies in the past have shown a decreased hospitalization rate for patients attending pulmonary rehab programs even with supporting documentation of less frequent admissions and decreased length of stay. Patients attending pulmonary rehab are provided with extensive education on disease management and infection control, taking medications correctly and consistently which all help to control issues of illness in the pulmonary patient. Overall I feel pulmonary rehab like cardiac rehab should be defined for consistent treatment of pulmonary patients especially with the growing number of patients diagnosed. A comprehensive guideline of care would promote more measurable outcomes and importance of promoting healthier lifestyles and risk factors for pulmonary patients to better manage their lung disease. An important aspect that is sometimes over looked is the fact that with patients covered as dictated by individual intermediataries with FeV1's, FVC's, or DLCO (from pulmonary function tests)< 60% that these pateints are endstage with very moderate to severe lung disease with outcomes drastically reduced due to the limitation of their lung disease. Pulmonary patients should be rehabilitated earlier in their disease process with better measured outcomes seen. Smoking cessation, along with other risk factor modifications should be provided to patients that will eventually progress to moderate/sever stages of lung disease. Cardiac pateints are referred to cardiac rehab to improve cardiovascular function and return to prior levels of functioning. Pulmonary Patients also need this same rehab concept but with more direction placed on management of disease process instead of a return to prior levels. At times care is provided not only for the measurable outcomes but also for the benefit of the quality of life for an individual. Patients that require pain control currently seen through hospice recieve this care not to reverse their condition but to provide quality of life and comfort for the patient. Pulmonary Rehab is much like that, difficult to secure measurable outcomes except patient generated opinions but definately improving quality of life and mentally satisfying for a patient with a terminal illness.

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The qualitative and quantitative benefits of pulmonary rehabilitation have been displayed in a number of studies and have been highlighted in several medical statements and guidelines from prestigious medical organizations. At one time this was not true and the benefits were purely anecdotal. However, the scientific evidence is now in support of rehab as a part of the standard of care. As a health care educator of professionals who work with chronic lung disease patients on a daily basis, I know the importance that pulmonary rehabilitation has in the care of those with chronic disease. From both money-saving and life-improving standpoints, national coverage determination for pulmonary rehabilitation makes good sense. The present situation is inequitable and ineffective. Please make the move toward national coverage determination so that a proven means of treatment is available to all Medicare recipients.

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Pulmonary rehabilitation when offered is absolutely necessary for patients with COPD. godsend to COPD patients. It can make their lives more enjoyable and can extend their life span. get them onto their feet and restore them to their lives. Both physicians and patients familiar with rehab feel that it is an important element of standard care for COPD. Pulmonary rehabilitation should be offered in all states, and I will be writing my senators and congressman to urge them to pass legislation supporting it.

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I feel that pulmonary rehabilitation does most certainly contribute to the physical and mental well being of people with COPD. Medicare and Medicaid should pay for these services and to deny anyone good health care because of their lack of ability to pay is outrageous in the USA today. Pulmonary Rehabilitation is a quality of life issue and not so much a measurable test of Rehabilitation. FeV1's,FVC might not increase that much, if at all but the quality of life (bathing, dressing, eating etc) will increase and improve. The small amount of dollars spent on rehabilitation today can only decrease the amount of money spent on long term care tomorrow.

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Pulmonary Rehabilitation is often difficult to define in terms of evidence based studies since the overall benefits are not typically measured outcomes like FVC and FEV1 results determined by Pulmonary Function Studies. Pulmonary Rehab should be evaluated as a result of outcomes generated by quality of life issues concerning the patient directly. Lung function is not going to improve for example like the ejection fraction does in instances of cardiac rehabilitation. As a respiratory therapist involved in both cardiac and pulmonary rehab, I have seen the improvement from both disease processes and yes while cardiac improvement is much more measurable pulmonary patients are generally the "sicker" of the two. They are much more limited due to the shortness of breath and require more attention focusing on improvement of daily activites (ADL's) such as bathing, dressing, cooking, etc rather than "aerobic" exercise. Patients with pulmonary disease need more psychological support along with specific education concerning diet, breathing retraining, and management of disease process. While pulmonary rehab patients in my experience do not excel to the measurable levels that cardiac patients typically benefit to, there are usually noted improvements in ADL's that the patient is able to perform. We conduct a pre and post survey of shortness of breath with daily activities of living (ADL's) and have patients rate from no shortness of breath to severe and document improvements noted by patient. While this is based on patient description, this tool does help to show patient perceived outcomes in shortness of breath levels. Documentation of oxygen levels along with dyspnea and percieved effort ratings with exercise can also show positive outcomes. While treatment options are limited for COPD and other pulmonary illnesses, pulmonary rehab should be an intrical part of the treatment regimen due to benefits in the quality of life of pulmonary patients. A quality of socialization that the program promotes is also a measurable outcome as percieved by the patient. Pulmonary patients due to their limitations and shortness of breath may tend to not participate in any activites therefore becoming even more limited in ADL's. Pulmonary Rehab teaches patients the importance of staying active, learning about their disease process, and beginning some form of exercise for strengthing. Studies in the past have shown a decreased hospitalization rate for patients attending pulmonary rehab programs even with supporting documentation of less frequent admissions and decreased length of stay. Patients attending pulmonary rehab are provided with extensive education on disease management and infection control, taking medications correctly and consistently which all help to control issues of illness in the pulmonary patient. Overall I feel pulmonary rehab like cardiac rehab should be defined for consistent treatment of pulmonary patients especially with the growing number of patients diagnosed. A comprehensive guideline of care would promote more measurable outcomes and importance of promoting healthier lifestyles and risk factors for pulmonary patients to better manage their lung disease. An important aspect that is sometimes over looked is the fact that with patients covered as dictated by individual intermediataries with FeV1's, FVC's, or DLCO (from pulmonary function tests)< 60% that these pateints are endstage with very moderate to severe lung disease with outcomes drastically reduced due to the limitation of their lung disease. Pulmonary patients should be rehabilitated earlier in their disease process with better measured outcomes seen. Smoking cessation, along with other risk factor modifications should be provided to patients that will eventually progress to moderate/sever stages of lung disease. Cardiac pateints are referred to cardiac rehab to improve cardiovascular function and return to prior levels of functioning. Pulmonary Patients also need this same rehab concept but with more direction placed on management of disease process instead of a return to prior levels. At times care is provided not only for the measurable outcomes but also for the benefit of the quality of life for an individual. Patients that require pain control currently seen through hospice recieve this care not to reverse their condition but to provide quality of life and comfort for the patient. Pulmonary Rehab is much like that, difficult to secure measurable outcomes except patient generated opinions but definately improving quality of life and mentally satisfying for a patient with a terminal illness.

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Pulmonary Rehabilitation has become in my opinion the standard of care for patients with chronic lung disease. Pulmonary disease is on the rise and is a increasingly important cause of morbidity and mortality today and in the future. If pulmonary rehab did not get a national coverage we would be doing our patiets an incrediable diservice. These patient would be re-admitted to the hospital more frequently and require more physician office visits for their COPD exacerbations.

The studies and evidence based guidelines have proven and I have seen it for myself on a every day basis that the COPD patient does improve and rely less on their family members to care for them due to the pulmonary rehab programs across the country. The patients I see improve in one way or another from (i.e. quality of life, functional daily activities, stength in upper and/or lower extremities, dyspnea, and their hospital re-admission rate just to name a few).

I am the coordinator of a pulmonary rehab program we see our patients 2 times a week for 8 weeks and we are very excited and passionate about our job to make life alittle easier for someone with chronic lung disease. If you saw these patients faces on the first day they exercise thinking they can't do this and on graduation day when they have achieved their initial goals or surpassed them and have one of these patients say thank you and shake your hand or give you a big hug then you know your in the right profession. This will not happen often enough if we can't get a national coverage for pulmonary rehab. Many of these patients will not have the opportunity to be educated and learn to master their chronic lung disease without a national coverage. Without a national coverage for pulmonary rehab it could possibly close some pulmonary rehabs across the country. This does not make any sense to me, because I thought we are here for the patient!

I hope that all information is taken into consideration before a decision is made, no knee jurk decisions please. Pulmonary Rehabs have been around for more than 30 years some bigger, some smaller, but I think its about time we recognize these programs as the standard of care for our COPD patients. All the evidence and studies show that these programs due in fact help COPD patients.

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Pulmonary rehabilitation when offered is a godsend to COPD patients. It canget them onto their feet and restore them to their lives. Not only does rehabilitationstrengthen and condition patients, it teaches them to pay attention to nutritionand how to understand and use their medicines to the best advantage.

No wonder physicians and patients familiar with rehab feel that it is an important element of standard care for COPD.

Pulmonary rehabilitation should be offered in all states, and I will be writing my senators and congressman to urge them to pass all legislation supporting it.

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As current president of Chapters 8 & 9, representing the New Orleans metropolitian area of the LSRC(Louisiana Society for Respiratory Care), I urge standardizing Pulmonary Rehabilitation Services in all states. This service is vital for COPD patients and other pulmonary afflicted patients(pulmonary fibrosis, pulmonary hypertension, asthma, etc). These services are generally conducted three times per week for 20-30 sessions, since Pulmonary Rehab focuses on increasing duration over intensity. Assuming qualification on Pulmonary Function Test, all candidates should be offered this quality of life improvement, which can also help the patient avoid further acute care intervention. Thank you for you consideration.
Susan Bailey, BS, RRT

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We provide a clinic located outpt. pulmonary rehab program. It runs twice a week for 16 attended sessions. Clients can join at any time and education is on a 1-to-1 basis. Most referrals come from pulmonary, internal medicine, and family practice. We follow AACVPR guidelines and is awaiting certification this fall. Our program is call "Pulmonary Health & Fitness" instead of rehab. The classes are kept small, usually 5-6 clients and last one hour. We have 6 sessions/day. Education topics include defining lung disease, knowing their PFT numbers, exercise training, breathing retraining, medications, depression, stress, and anxiety control, nutrition, travel, oxygen therapy, staying healthy, smoking cessation, physician communication, etc.. Two registered respiratory therapists run each session and are required to complete specific dept. training beforehand and continued education specific to pulmonary rehab. annually. Oxygen saturation, blood pressure, heart rate, levels of dyspnea are measured routinely and blood glucose and telemetry is available if needed. The exercise portion includes treadmills, nusteps, arm bikes, airdynes, ellipticals, and free weights. Psychosocial, physical, and learning needs assessments are completed before starting the program. Pre and post testing with 6-minute walks,self-confidence questionaires, and dyspnea questionaires are also required. Program evaluation by the client is completed at end of phase 1. These tests are repeated routinely to enable us to graph their progress and find needed areas of improvement. Individual progress reports are given to the client and another placed in patient's clinic chart after physician review. Department summary reports are reviewed by the program's medical directors and supervisors. In 2006, our clients had shown an average increase in exercise tolerance of 20%, increased self- confidence(questionaire) of 34%, and the dyspnea score improved 17%. Most of our clients continue to Phase 2 and some have been with us for 8-9 years. The definition we use for our Pulmonary Health & Fitness Program is "Through a team of health professionals, we provide the client and family with information and support to meet the day-to-day challenges of living with a chronic lung disorder. Our main objectives are 1) to control and alleviate the symptoms and complications of pulmonary disease, 2) to teach the client how to achieve an optimal level of independence and physical capabilities, 3) to reduce hospitalizations and reduce health care costs. I have done pulmonary rehab for many, many years. It's amazing how fast we can see improvements in our clients with just a little encouragement and patience. If more information is needed, please contact me. Thank you, Brenda Lusty, BS,RRT,CPFT,AE-C

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Several studies and outcome reviews show that Pulmonary Rehabilitation is therapeutic and promotes wellness. It is indefensable that cardiac patients receive 36 sessions after an event while pulmonary disease patients receive only 30 sessions. This is plainly discrimination.

Under the current system, a patient must wait until their illness reaches significant disability before Pulmopnary Rehab is indicated. It is ideal to treat individuals before serious disability occurs in order to promote wellness and avoid hospital stays. Several private insurance companies recognize that wellness prevents hospital stays and have begun follow-up programs that promote exercise, diet and education. A national standard is needed to keep pace with current trends and thwart severe disability from pulmonary disease before a patient reaches less then 60% on pulmonary function tests.

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Dear CMS,

Timing plays an important part in determining many aspects of our lives. The approval of the NCD for Pulmonary Rehabilitation is no exception. As I read your well written document: "Proposed Decision Memo for Pulmonary Rehabilitation (CAG-00356N)", I was astonished at your 'Decision Summary'! Your 'Memo' follows that decision summary with an almost 'glowing' review of what Pulmonary Rehabilitation has done for our patients with a chronic lung disease!

I surely hope that you can, in this next 30 days, review the article in the May 2007 issue of CHEST in which Dr Andrew L. Ries, MD, MPH, FCCP and colleagues have written a well put together article on Pulmonary Rehab. It appears that this article was not studied as was the articles that you listed in your 'memo'! It appears that 'Timing' was the problem. Dr Ries has many years of experience with Pulmonary Rehabilitation. I've sat with him in one meeting with his Pulmonary Rehab staff in the UCSD Pulmonary Rehabilitation conference room, and noted the insight he has on this subject! His expertise is surely exhibited in the CHEST article. It does review a number of RCT's from which we can draw on, to determine the efficacy of Pulmonary Rehabilitation programs!

There are a number of aspects of Pulmonary Rehab touched on in Dr Ries' paper that are worth noting. Most of the recommendations that I have chosen are 'graded'. The following table explains this 'grading'.

Table 1. Relationship of Strength of the Supporting Evidence to the Balance of Benefits to Risks and Burdens*
Strength of Evidence
Balance of Benefits to Risks and Burdens
________________________________________ ________________________________________
Benefits Outweigh Risks/Burdens
Risks/Burdens Outweigh Benefits
Evenly Balanced Uncertain
High 1A 1A 2A
Moderate 1B 1B 2B
Low or very low 1C 1C 2C 2C

* 1A = strong recommendation; 1B = strong recommendation; 1C = strong recommendation; 2A = weak recommendation; 2B = weak recommendation; 2C = weak recommendation.

Please note at least these recommendations, as I believe they answer some of the questions for which you have asked comments on:

Recommendations
1. A program of exercise training of the muscles of ambulation is recommended as a mandatory component of pulmonary rehabilitation for patients with COPD. Grade of recommendation, 1A
2. Pulmonary rehabilitation improves the symptom of dyspnea in patients with COPD: Grade of recommendation, 1A Recommendation
3. Pulmonary rehabilitation improves HRQOL in patients with COPD. Grade of recommendation, 1A Recommendation
8. Six to twelve weeks of pulmonary rehabilitation produces benefits in several outcomes that decline gradually over 12 to 18 months. Grade of recommendation, 1A. Some benefits, such as HRQOL, remain above control levels at 12 to 18 months. Grade of recommendation, 1C Recommendations
11. Lower extremity exercise training at higher exercise intensity produces greater physiologic benefits than lower intensity training in patients with COPD. Grade of recommendation, 1B
12. Both low-intensity and high-intensity exercise training produce clinical benefits for patients with COPD. Grade of recommendation, 1A Recommendation
13. The addition of a strength-training component to a program of pulmonary rehabilitation increases muscle strength and muscle mass. Strength of evidence, 1A Recommendation
15. Unsupported endurance training of the upper extremities is beneficial in patients with COPD and should be included in pulmonary rehabilitation programs. Grade of recommendation, 1A Recommendation
16. The scientific evidence does not support the routine use of IMT as an essential component of pulmonary rehabilitation. Grade of recommendation, 1B Recommendations
17. Education should be an integral component of pulmonary rehabilitation. Education should include information on collaborative self-management, and the prevention and treatment of exacerbations. Grade of recommendation, 1B
19. Although no recommendation is provided, since scientific evidence is lacking, current practice and expert opinion support the inclusion of psychosocial interventions as a component of comprehensive pulmonary rehabilitation programs for patients with COPD. Recommendations
24. Pulmonary rehabilitation is beneficial for patients with some chronic respiratory diseases other than COPD. Grade of recommendation, 1B
25. Although no recommendation is provided since scientific evidence is lacking, the current practice and expert opinion suggest that pulmonary rehabilitation for patients with chronic respiratory diseases other than COPD should be modified to include treatment strategies specific to individual diseases and patients, in addition to treatment strategies common to both COPD and non-COPD patients.

Each recommendation is backed with statistics, studies and other information. It is my hope (and the hope of many other Pulmonary Rehabilitation programs) that you reconsider your decision for an NCD for Pulmonary Rehabilitation. Certainly, our patients need this service to give them a better Quality or Life, and Medicare needs this service to better meet the needs of our patients, and to save Medicare itself countless millions ($) in reduced spending for health care services!!!Respectfully,
Charles S. Broderick
Charles (Chuck) Broderick RRT, CPFT, RCP
Coordinator Pulmonary Wellness Center (aka Pulmonary Rehabilitation)
e-mail: charles.broderick@tmcaz.com
tel: 520-324-2636
fax: 520-324-1677
Tucson Medical Center
5301 E Grant Rd
Tucson, AZ 85712

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Imagine having to breathe through a straw 24/7. Then imagine trying to do the simplest of tasks while breathing through that straw. This is how individuals with chronic lung disease feel every day. Pulmonary rehab is an opportunity for them to learn to manage their condition through education and a conditioning program. Pulmonary rehab should be defined as a multidisciplinary program, which maximizes the life potential of individuals suffering from chronic pulmonary disease. Goals should be individualized, but ultimately teach the patient how to compensate for their compromised lung status, thus allowing them to lead productive lives.

General guidelines would permit individual training and counseling, along with the opportunity to consult supportive healthcare professionals, such as dieticians, physical therapists and mental health specialists. Outcomes would be focused on progress toward patient goals.

Muscle reconditioning is vital for patients to advance in activities of daily living. It takes 2 weeks (3 sessions per week) to begin to see some conditioning, and at least 8 weeks (3 sessions per week) to see noticeable improvement in the patient's stamina.

We have a number of patients who have completed a Phase II program and are exercising regularly in a maintenance program. The hours they spend with others who have similar conditions provide a support system particularly for those who do not have any family members available to assist them. It is amazing to see the friendships that form. It is also amazing to see the bonds that are so strong within the class. The members not only are accountable to themselves, but to each other.

The population of patients who have been through a Phase II are on fixed incomes. They would not be able to afford the Phase II program 3 times a week for 2 to 3 months. Nearly all have told us, "If it were not for this program, I would not be doing what I am able to do today". For some that is as simple as being able to walk in the grocery store without becoming short of breath, for others, it was being able to stop oxygen therapy.

We are the support system of these individuals, and we are also their advocates. Please allow them to live the quality of life that everyone deserves.

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I have run a Pulmonary Rehabilitaiton Program for 17 years. I have seen patients able to do better self care, return to work, return to recreational activities and socail gatherings and undergo major surgery that previously would have killed them all due to the learned breathing techniques and exercise program that decreased their medical acuity. As a member of the American Association for Respiratory Care and the American Associatiofor Cardiovascular and Pulmonary Rehabilitation, I know these societies have evidence for the benefits of Pulmonary Rehabilitation. The NIH is using Pulmonary Rehabilitation as the GOLD standard for treatment of COPD and other lung diseases. I would hope CMS would take a good look at these before making a decision against a very cost-effective program that saves health care dollars in the long run.

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After Pulmonary Rehabilitation for the initial hospital stay, the positive effects seem to be long-lasting in most patients. Progression of the disease and the resulting decrease in quality of life and physical capabilities, however, seem to gradually affect the ability of many patients to continue doing the things they found so helpful. Perhaps a periodic return to a modified original Rehab. Refresher course would be both an emotional and physical recharge for these patients and decrease their probable avoidance of social interaction and increase the confidance in their ability to regain more control over their lives.

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Defination- AACVPR describes it very well in their Guidelines for Pulmonary Rehabilitatio Programs as Pulmonary rehabilitation is a multidiscipilinary program of care for patients with chronic respiratory impairment that is individually tailored and designed to optimize physical and social performance and autonomy.
Components- Slow progression of endurance exercise and education pieces that include breathing retraining,stress management, proper med use ,nutrition,Pefr monitoring and others that the MD may order. Our setting-2 days per week for 1 1/2 hours in the cardic/pulmonary rehab gym. Pts also recieve a home exercise program for daily use.
Outcomes-6mwt plus knowledge and disability tests . All before and after program Clinical trials- the Nett study which plotted pulmonary rehab against lung surgery produced valuable info of the benefits and safety of pulmonary rehab.

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I am a RT who works in Pulmonary Rehab and I am encouraging you to move ahead with proposed coverage for Pulm. Rehab. I see proof everyday of decreased hospitalization and emergency department visits and significant improvement in quality of life for the Pulm. Rehab patients we see. A individualized plan of graded exercise to build strength and endurance, combined with education and information is critical to improving lives of COPD patients.

Thank you for your consideration of this matter and I look forward to positive news SOON!

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The quantative and qualitative outcomes for the PulRehab patients a my facikity clearly demonstrate reduced hospitalizations, reduced lengths of stay by 2-3 days and fewer emergency room visits when comparing the three years before and after graduating from out PulRehab progam.

Many other centers have reported similar results.

I therefore fail to see CMS' hesitancy to provide an affirmative national coverage decision when the patients' outcomes are so easily measured and so clear.

This is not to mention the improvement in graduate's self sifficiency, mobility, energy and ability to resume a more rewarding lifestyle.

The argument against PulRehab is that is is required because of lifestyle choices. However, CMS is willing to pay the downstream hospitalization costs of sequeale of those lifestyle choices. How does that choice make any sense when costs for PulRehab are a tenth the cost of hospitalization?

THanks for considering my comments.

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I have run a Comprehensive Pulm Rehab for 20 years. You can not compare A CORF to a Hospital based complete program. It is very important that Pulmonary Patients learn about their disease, proper breathing techniques with activities of daily living, proper diet, proper use of their home oxygen and home repritory medications. These are areas that CORF's do not cover. Over the years I have seen many patients who are not following their Doctors advise and have come up with interesting methoids of using their oxygen and using their home meds that have only come to light in our Pulm Rehab, through discussion with me and with other patient in the group setting. Please do not deny Pulmonary patients these valuable Hospital based comprehensive programs!!

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I am the clinical coordinator of the pulmonary rehab program @ Lawrence & Memorial Hospital in New London, CT.

We follow the Pulmonary Rehabilitation guidelines set by the AACVPR. We are a certified program, by the AACVPR.

Our program is an outpatient hospital based program. The patients meet 2x week for 1 1/2 hours for a total of 10 weeks / 20 sessions. There is an intial evaluation prior to starting the program.Specifics:Staffing includes: Medical Director, RN, RRT and PT. SW,OT & Dietician are available via referral.Class size: 10 program patients

The program consists of approx 53 minutes of exercise (upper extremity weights, treadmill, nustep, bike/airdyne, lower extremity exercises) and 15-20 minutes of education. Education consists of a range of topics e.g. nutrition, pul. medication and hygiene, benefits of exercise, anatomy & physiology of lung disease, breating training, managing your illness ....

We monitor outcome data in 4 catagories. Clinical (MET level), Behavioral(knowledge of lung disease), Health (Qol) and Service (patient satisfaction).

We also offer a maintenance program after the 10 weeks here at the hospital. If the patient chooses not to stay at the hospital, for what ever reason, they are provided with a list of all the community programs that are available to them to continue their exercise regimen.

***Pulmonary rehabilitation is not only beneficial for patient with COPD(emphysema,chronic bronchitis and asthma). Patients who have restrictive diseases e.g.(sarcoidosis, idiopathic pul. fibrosis) Post lung surgery patients for CA . Pre & post lung transplant patients, benefit as well. * Pulmonary rehab is usually mandatory for anyone being considered for or is on a lung transplant list.
*****Summary:

I have been involved in many areas of health care during my career. :Resiratory Therapist,ICU nurse, Case Manager, Manager of Respiratory & Cardiology Services and now Clinical Coordinator of Pul. Rehab.

I have worked across the continum of care. I understand how chronic disease impacts the system.

The data is there, COPD (lung disease) is the 4th largest killer in this country. Why would we not want to do something about this problem? Don't we as a society want to decrease health care costs? Don't we want to decrease utilization of office visits and hospitalizations? If the answer is yes, then why the dragging of feet to recognize pulmonary rehabilitation?

The cost of one person going into a pulmonary rehab program is approx $2,000.00. The studies show that with chronic illnesses, the amount of resources used are enormous. Compare the cost of just one hospitalization to the cost of pulmonary rehab. If you can decrease the number of hospitalziations even by one per patient,think of the money saved. Millions.

The primary goal of pulmonary rehab is to improve muscle strength and endurance and to increase the patients knowledge of how to maintain and control a pulmonary disease. Improvements in these areas decreases SOB, increases tolerance for activities of daily living and therefore increases quality of life and improves psychological health. This in turn benefits the health system as a whole as these patients utilize less hospital visits and office visits. They remain productive members of society. Your investigation of the literature supports this view.

This population deserves the same benefit as cardiac patients do.

Studies are great, but they lack the faces...the patients really behind those numbers. If you sent a team out to view programs you would know the benefit the patients receive from these programs. They would tell you! It may not be scientific but you wouldn't question anymore if these programs worked. The dollars to reimburse these programs are well spent.

Frustrated provider, happy practitioner who knows she makes a difference.
Laurie Corona RRT, RN, MS

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I am concerned that Medicare does not intend to promulgate a National Coverage Determination for Pulmonary Rehabilitation. Although it appears that the respiratory therapy services identified in 42 CFR §410.100(e)(1) to (2)(vi) should be adequate, the actual services provided vary from one geographic location to another and from one facility to another. A national standard of pulmonary rehabilitation would ensure that all qualifying patients would be eligible for and receive the same respiratory services.

It has become clear that pulmonary rehabilitation is the second most important activity that improves quality of life and enhanced health status of pulmonary patients. Its importance is secondary only to compliance with medication regimens.

I draw your attention to the following

Supplement to CHEST the Journal of the American College of Chest Physicians

Pulmonary Rehabilitation

Joint ACCP/AACVPR Evidence-Based Clinical Practice Guidelines

ABSTRACT

Background: Pulmonary rehabilitation has become a standard of care for patients with chronic lung diseases. This document provides a systematic, evidence-based review of the pulmonary rehabilitation literature that updates the 1997 guidelines published by the American College of Chest Physicians (ACCP) and the American Association of Cardiovascular and Pulmonary Rehabilitation.

Methods: The guideline panel reviewed evidence tables, which were prepared by the ACCP Clinical Research Analyst, that were based on a systematic review of published literature from 1996 to 2004. This guideline updates the previous recommendations and also examines new areas of research relevant to pulmonary rehabilitation. Recommendations were developed by consensus and rated according to the ACCP guideline grading system.

Results: The new evidence strengthens the previous recommendations supporting the benefits of lower and upper extremity exercise training and improvements in dyspnea and health-related quality-of-life outcomes of pulmonary rehabilitation. Additional evidence supports improvements in health-care utilization and psychosocial outcomes. There are few additional data about survival. Some new evidence indicates that longer term rehabilitation, maintenance strategies following rehabilitation, and the incorporation of education and strength training in pulmonary rehabilitation are beneficial. Current evidence does not support the routine use of inspiratory muscle training, anabolic drugs, or nutritional supplementation in pulmonary rehabilitation. Evidence does support the use of supplemental oxygen therapy for patients with severe hypoxemia at rest or with exercise. Noninvasive ventilation may be helpful for selected patients with advanced COPD. Finally, pulmonary rehabilitation appears to benefit patients with chronic lung diseases other than COPD.

Conclusions: There is substantial new evidence that pulmonary rehabilitation is beneficial for patients with COPD and other chronic lung diseases. Several areas of research provide opportunities for future research that can advance the field and make rehabilitative treatment available to many more eligible patients in need.

Received for publication October 2, 2006. Accepted for publication February 2, 2007.

SOURCE: http://www.chestjournal.org/cgi/content/full/131/5_suppl/4S#SEC10

The full document contains a wealth of information on the benefits of pulmonary rehabilitation.

Thank you for the opportunity to comment.

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