The fight to defend access to pulmonary rehabilitation for patients with pulmonary fibrosis continues
Below is a press release/comment from our friends at the Coalition for Pulmonary Fibrosis. The HPS Network serves with the Coalition on the Public Advisory Board of the American Thoracic Society. Long time HPS’ers will remember that we joined with the Coalition and other lung disease groups to lobby Congress to get Medicare to cover pulmonary rehabilitation. It’s a battle we won in Congress, but as with so many things, the battle doesn’t stop there. As the saying goes, the devil is in the details.
Although the spirit of the law that was passed would include access to pulmonary rehabilitation for patients with pulmonary fibrosis (including HPS’ers) – when it came time to write the regulations, we’ve run into trouble.
I’m posting this so that those of you in the HPS community are aware of the issue in case we need to mobilize further to ensure access to pulmonary rehabilitation.
Many commercial insurance companies follow the lead of Medicare – thus this is important for everyone, not just those on Medicare.
CPF Submits Comment for Medicare Proposed Ruling that would Eliminate PF Patients from Pulmonary Rehabilitation Benefit
The Coalition for Pulmonary Fibrosis (CPF) is a national nonprofit organization representing the interests of 128,000 patients who suffer from Pulmonary Fibrosis (PF), a deadly lung disease with no FDA approved treatment, no known cause and no cure. The CPF would like to offer comment to the proposed CMS ruling related to Pulmonary Rehabilitation (CMS-1413-P – “Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010”) and specifically address the “coverage” portion of the CMS proposed ruling as named above with regard to PF patients. Please review our comments, as well as cited peer-reviewed medical journal articles and a listing of supporting pulmonary fibrosis physicians and scientists and their affiliations.
Under your proposal, PF patients will not only be excluded from coverage within the national coverage policy for cardiac and pulmonary rehabilitation - a policy that was written with them and patients like them in mind - they will likely lose existing coverage from private insurance companies due to CMS actions. This is a case study in the challenges representative of patients fighting rare diseases like PF. Namely, that healthcare coverage for those with rare diseases like PF is materially and negatively impacted largely due to the size of its patient population, a lack of awareness of the benefits of cardiac and pulmonary rehabilitation on these patients, and, frankly, the increased attention typically afforded diseases of higher prevalence, such as COPD, in Federal programs. In addition, this proposal fails to recognize the clear benefits of pulmonary rehabilitation on PF patients. While COPD is generally considered to be a long-term chronic illness, PF is a devastating and lethal disease for which pulmonary rehabilitation has shown to be one of the few treatment options to help a patient maintain a dignified quality of life, which is especially critical given that PF life expectancy averages 2-5 years following diagnosis. Currently, the only lifesaving therapy for PF is lung transplantation. The proposed CMS ruling would hurt these PF patients additionally and at a critical time in their treatment. Pulmonary Rehab has been integral in pre-transplant conditioning of patients with end stage lung disease and has been demonstrated to improve survival. Pre-transplant de-conditioning is considered by pulmonary experts to be one of the recognized root causes of adverse outcomes post transplant. In addition, PF patients have the co-morbid condition pulmonary hypertension (PH). Pulmonary Rehab has been shown to be beneficial for PH, as well, doubly benefitting these patients. The CMS proposed ruling, is stated: “Because there is not data to substantiate significantly improved outcomes for any other medical conditions, we are proposing to allow moderate to severe COPD as the only covered condition.” In lieu of no other effective treatment modality, there is growing evidence that pulmonary rehab is one of the only modalities that has the potential to help PF patients. There are at least eight published studies in major peer-reviewed medical journals showing the benefits of pulmonary rehab to the PF patient population. There is, in fact, strong evidence that PF patients benefit from pulmonary rehab and are able to maintain a higher quality of life than without the program. We request that CMS review this research evidence and provide much-needed coverage for these patients who have no other treatment options available to them. We cite three peer-reviewed research findings in support of this opinion below:
1. CMS’ proposed ruling includes COPD patients. A recent study published in Respiratory Medicine compared PF and COPD regarding the benefits of pulmonary rehab:“Although IPF and COPD are, in many respects, drastically different diseases, they are also similar in many ways: patients with COPD have some of the same limitations as patients with IPF. For example, both have impaired lung mechanics, increased work of breathing, and abnormal gas exchange. As is likely true for patients with IPF, those with COPD also have higher-than-expected rates of anxiety and depression much greater than rates in general medical patients or in people from the community and in many studies with rates approaching 50%. Patients with COPD have impaired QOL; for a given degree of disease severity, patients with IPF appear to have impairments in QOL that are at least as severe as if not more severe than patients with COPD.” This paper also concludes: “Pulmonary rehabilitation helps to accomplish many of these goals in patients with chronic obstructive pulmonary disease, and emerging data suggest that it may do the same for patients with IPF.” (Jeffrey J. Swigris et al., Pulmonary rehabilitation in idiopathic pulmonary fibrosis: A call for continued investigation, Respiratory Medicine (2008), doi:10.1016/j.rmed.2008.08.014)
2. Another recent study’s results published in CHEST support PR as a therapy for PF patients:“A statistically significant difference was seen in both the change in Borg score and 6MWT distance after PR (p < 0.0001). These changes were consistent with previously established clinically significant differences. Baseline 6MWT distance was a significant predictor of change in 6MWT distance (p < 0.0001), with increasing baseline 6MWT distance predicting a smaller improvement after PR. These results suggest that PR should be considered as a standard of care for patients with ILD.” This study demonstrates that patients with ILD have statistically and clinically significant improvements in functional status and dyspnea with PR, and that this benefit is more pronounced in patients with poor functional status. While emphasizing the need for further research, we strongly suggest that PR should be considered as a standard of care for patients with ILD. (Ferreira et al, CHEST 2009; 135:442–447)
3. In 2007, a small randomized trial showed differences in 6MW and HRQOL using only PF patients.The study showed that “although there were some differences in the baseline 6MWD and total health-related quality of life score which were not statistically significant, marked improvements were observed in the 6MWD (mean difference 46.3 m (95% CI: 8.3–84.4), P < 0.05) and the total health-related quality of life score (-6.1 (95% CI: -11.7 to -0.5), P < 0.05). Pulmonary rehabilitation improves both exercise capacity and health-related quality of life in patients with IPF.” (Nishiyama et al, Respirology 2008;13:394—399).
We concur with additional and combined important citations as submitted by the American Thoracic Society including:PF is included in a category of lung disease that includes 200 diseases called ILD or Interstitial Lung Disease. The most common of these disease entities is idiopathic pulmonary fibrosis (IPF) (ATS/ERS, statement 2002). Patients have severe exertional dyspnea, cough, exercise intolerance, altered lung mechanics with low lung compliance (Marciniuk DD, et al 1994, Markovitz GH & Cooper CB, 1998) alterations in respiratory drive and gas exchange disturbances (with diffusion impairment, increased dead space, and ventilation–perfusion mismatch). Exercise-induced hypoxemia is particularly severe among patients with ILD, especially those persons with moderate to severe disease (Markovitz GH & Cooper CB, 1998, Hsia CC, 1999, Hansen JE & Wasserman K: 1996, Harris-Eze AO, et al: 1994). Although ILD is often refractory to conventional medical treatments, pulmonary rehabilitation targets several areas of morbidity that can contribute to disability and impaired quality of life, including cardiovascular deconditioning, dyspnea and control of mood disorders (Holland AE, et al in Thorax, 2008, Nishiyama O, et al 2008, Ferreira G, et al 2006 & 2009, Jastrzebski D, et al 2006, Naji NA, et al 2006 and Foster S, et al 1990). A recent multicenter trial of ILD patients found significant improvement in dyspnea and six minute walk distance (6MWD) after pulmonary rehabilitation, consistent with established clinically significant differences (Ferreira A, et al 2009). Nishiyama and colleagues (2008) randomized patients with idiopathic pulmonary fibrosis to outpatient PR or standard therapy. They found significant improvement in 6MWD and the St. Georges Respiratory Questionnaire in the PR group. Additionally, in a 2008 Cochrane review, Holland and Hill identified improvement in 6MWD, dyspnea and quality of life after pulmonary rehabilitation. In the study by Ferreira, Feuerman, and Spiegler, patients with pulmonary fibrosis, among other diseases, were shown to achieve significant gains in 6MWT distance and QOL after PR. Under the CMS proposed ruling, PF patients with urgent needs will be left out of this important medical services area and will suffer even more due to lack of pulmonary rehab treatment.By making the cuts you propose, CMS is effectively depriving our patients of a chance to prevent, reduce or delay consequences of respiratory failure and the U.S. Healthcare system will be forced to pay the higher costs of dealing with the issues that will come as a result of the lack of pulmonary rehabilitation for patients. In addition, costs to productivity and quality of life will become substantial. By avoiding paying for much needed preventative and maintenance care for these terminally and chronically ill respiratory patients, costs will come in the form of payment for increased hospitalizations, higher critical care costs, and substantial end-of-life costs.
It is our strong recommendation that CMS consider providing coverage for the patients with which the national coverage policy was written, including patients who suffer from PF.
Sincerely, The Coalition for Pulmonary Fibrosis
Top Pulmonary Fibrosis Experts Who Join the CPF in making these comments:Marvin Schwarz, MD, James C. Campbell Professor of Medicine University of Colorado Health Sciences CenterJames Loyd, MD, Medical Co-Director, Lung Transplant Program Medical Co-Director, FLOLAN Program for Primary Pulmonary Hypertension, Vanderbilt University Medical CenterAdaani Frost, MD, Professor of Medicine, Baylor College of MedicinePaul Noble, MD, Professor of Medicine Division Chief, Allergy & Critical Care Medicine, Duke University Medical CenterGlenn Rosen, MD, Associate Professor of Medicine, Division of Pulmonary & Critical CareCo-Director, Stanford University Lung Disease Center, Stanford Medical Center Marilyn Glassberg, MD, Assistant Professor of Medicine, Division of Pulmonary & Critical Care Medicine, University of Miami/Jackson Memorial Medical CenterJeffrey Golden, MD, Medical Director, Lung Transplantation Director, Interstitial Lung Disease Clinic University of California, San FranciscoHarold Collard, MD, Assistant Clinical Professor of MedicineDirector, Interstitial Lung Disease Program Division of Pulmonary and Critical Care Medicine, University of California, San FranciscoStephen Nathan, MD, Medical Director, Lung Transplant & Advanced Lung Disease Programs, Inova Fairfax HospitalMaria Padilla, MD, Associate Professor of Medicine Director of the Advanced Lung Disease Program, Mt. Sinai Medical CenterGanesh Raghu, MD, Professor of Medicine, University of Washington, Chief of Chest ClinicDirector, Lung Transplant Program and Interstitial Lung Disease Program University of Washington Medical CenterFernando Martinez, MD, Associate Professor, Division of Pulmonary and Critical Care MedicineDirector, Lung Volume Reduction Program, Medical Director, Pulmonary Diagnostic Services University of Michigan Medical Center
Although the spirit of the law that was passed would include access to pulmonary rehabilitation for patients with pulmonary fibrosis (including HPS’ers) – when it came time to write the regulations, we’ve run into trouble.
I’m posting this so that those of you in the HPS community are aware of the issue in case we need to mobilize further to ensure access to pulmonary rehabilitation.
Many commercial insurance companies follow the lead of Medicare – thus this is important for everyone, not just those on Medicare.
CPF Submits Comment for Medicare Proposed Ruling that would Eliminate PF Patients from Pulmonary Rehabilitation Benefit
The Coalition for Pulmonary Fibrosis (CPF) is a national nonprofit organization representing the interests of 128,000 patients who suffer from Pulmonary Fibrosis (PF), a deadly lung disease with no FDA approved treatment, no known cause and no cure. The CPF would like to offer comment to the proposed CMS ruling related to Pulmonary Rehabilitation (CMS-1413-P – “Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010”) and specifically address the “coverage” portion of the CMS proposed ruling as named above with regard to PF patients. Please review our comments, as well as cited peer-reviewed medical journal articles and a listing of supporting pulmonary fibrosis physicians and scientists and their affiliations.
Under your proposal, PF patients will not only be excluded from coverage within the national coverage policy for cardiac and pulmonary rehabilitation - a policy that was written with them and patients like them in mind - they will likely lose existing coverage from private insurance companies due to CMS actions. This is a case study in the challenges representative of patients fighting rare diseases like PF. Namely, that healthcare coverage for those with rare diseases like PF is materially and negatively impacted largely due to the size of its patient population, a lack of awareness of the benefits of cardiac and pulmonary rehabilitation on these patients, and, frankly, the increased attention typically afforded diseases of higher prevalence, such as COPD, in Federal programs. In addition, this proposal fails to recognize the clear benefits of pulmonary rehabilitation on PF patients. While COPD is generally considered to be a long-term chronic illness, PF is a devastating and lethal disease for which pulmonary rehabilitation has shown to be one of the few treatment options to help a patient maintain a dignified quality of life, which is especially critical given that PF life expectancy averages 2-5 years following diagnosis. Currently, the only lifesaving therapy for PF is lung transplantation. The proposed CMS ruling would hurt these PF patients additionally and at a critical time in their treatment. Pulmonary Rehab has been integral in pre-transplant conditioning of patients with end stage lung disease and has been demonstrated to improve survival. Pre-transplant de-conditioning is considered by pulmonary experts to be one of the recognized root causes of adverse outcomes post transplant. In addition, PF patients have the co-morbid condition pulmonary hypertension (PH). Pulmonary Rehab has been shown to be beneficial for PH, as well, doubly benefitting these patients. The CMS proposed ruling, is stated: “Because there is not data to substantiate significantly improved outcomes for any other medical conditions, we are proposing to allow moderate to severe COPD as the only covered condition.” In lieu of no other effective treatment modality, there is growing evidence that pulmonary rehab is one of the only modalities that has the potential to help PF patients. There are at least eight published studies in major peer-reviewed medical journals showing the benefits of pulmonary rehab to the PF patient population. There is, in fact, strong evidence that PF patients benefit from pulmonary rehab and are able to maintain a higher quality of life than without the program. We request that CMS review this research evidence and provide much-needed coverage for these patients who have no other treatment options available to them. We cite three peer-reviewed research findings in support of this opinion below:
1. CMS’ proposed ruling includes COPD patients. A recent study published in Respiratory Medicine compared PF and COPD regarding the benefits of pulmonary rehab:“Although IPF and COPD are, in many respects, drastically different diseases, they are also similar in many ways: patients with COPD have some of the same limitations as patients with IPF. For example, both have impaired lung mechanics, increased work of breathing, and abnormal gas exchange. As is likely true for patients with IPF, those with COPD also have higher-than-expected rates of anxiety and depression much greater than rates in general medical patients or in people from the community and in many studies with rates approaching 50%. Patients with COPD have impaired QOL; for a given degree of disease severity, patients with IPF appear to have impairments in QOL that are at least as severe as if not more severe than patients with COPD.” This paper also concludes: “Pulmonary rehabilitation helps to accomplish many of these goals in patients with chronic obstructive pulmonary disease, and emerging data suggest that it may do the same for patients with IPF.” (Jeffrey J. Swigris et al., Pulmonary rehabilitation in idiopathic pulmonary fibrosis: A call for continued investigation, Respiratory Medicine (2008), doi:10.1016/j.rmed.2008.08.014)
2. Another recent study’s results published in CHEST support PR as a therapy for PF patients:“A statistically significant difference was seen in both the change in Borg score and 6MWT distance after PR (p < 0.0001). These changes were consistent with previously established clinically significant differences. Baseline 6MWT distance was a significant predictor of change in 6MWT distance (p < 0.0001), with increasing baseline 6MWT distance predicting a smaller improvement after PR. These results suggest that PR should be considered as a standard of care for patients with ILD.” This study demonstrates that patients with ILD have statistically and clinically significant improvements in functional status and dyspnea with PR, and that this benefit is more pronounced in patients with poor functional status. While emphasizing the need for further research, we strongly suggest that PR should be considered as a standard of care for patients with ILD. (Ferreira et al, CHEST 2009; 135:442–447)
3. In 2007, a small randomized trial showed differences in 6MW and HRQOL using only PF patients.The study showed that “although there were some differences in the baseline 6MWD and total health-related quality of life score which were not statistically significant, marked improvements were observed in the 6MWD (mean difference 46.3 m (95% CI: 8.3–84.4), P < 0.05) and the total health-related quality of life score (-6.1 (95% CI: -11.7 to -0.5), P < 0.05). Pulmonary rehabilitation improves both exercise capacity and health-related quality of life in patients with IPF.” (Nishiyama et al, Respirology 2008;13:394—399).
We concur with additional and combined important citations as submitted by the American Thoracic Society including:PF is included in a category of lung disease that includes 200 diseases called ILD or Interstitial Lung Disease. The most common of these disease entities is idiopathic pulmonary fibrosis (IPF) (ATS/ERS, statement 2002). Patients have severe exertional dyspnea, cough, exercise intolerance, altered lung mechanics with low lung compliance (Marciniuk DD, et al 1994, Markovitz GH & Cooper CB, 1998) alterations in respiratory drive and gas exchange disturbances (with diffusion impairment, increased dead space, and ventilation–perfusion mismatch). Exercise-induced hypoxemia is particularly severe among patients with ILD, especially those persons with moderate to severe disease (Markovitz GH & Cooper CB, 1998, Hsia CC, 1999, Hansen JE & Wasserman K: 1996, Harris-Eze AO, et al: 1994). Although ILD is often refractory to conventional medical treatments, pulmonary rehabilitation targets several areas of morbidity that can contribute to disability and impaired quality of life, including cardiovascular deconditioning, dyspnea and control of mood disorders (Holland AE, et al in Thorax, 2008, Nishiyama O, et al 2008, Ferreira G, et al 2006 & 2009, Jastrzebski D, et al 2006, Naji NA, et al 2006 and Foster S, et al 1990). A recent multicenter trial of ILD patients found significant improvement in dyspnea and six minute walk distance (6MWD) after pulmonary rehabilitation, consistent with established clinically significant differences (Ferreira A, et al 2009). Nishiyama and colleagues (2008) randomized patients with idiopathic pulmonary fibrosis to outpatient PR or standard therapy. They found significant improvement in 6MWD and the St. Georges Respiratory Questionnaire in the PR group. Additionally, in a 2008 Cochrane review, Holland and Hill identified improvement in 6MWD, dyspnea and quality of life after pulmonary rehabilitation. In the study by Ferreira, Feuerman, and Spiegler, patients with pulmonary fibrosis, among other diseases, were shown to achieve significant gains in 6MWT distance and QOL after PR. Under the CMS proposed ruling, PF patients with urgent needs will be left out of this important medical services area and will suffer even more due to lack of pulmonary rehab treatment.By making the cuts you propose, CMS is effectively depriving our patients of a chance to prevent, reduce or delay consequences of respiratory failure and the U.S. Healthcare system will be forced to pay the higher costs of dealing with the issues that will come as a result of the lack of pulmonary rehabilitation for patients. In addition, costs to productivity and quality of life will become substantial. By avoiding paying for much needed preventative and maintenance care for these terminally and chronically ill respiratory patients, costs will come in the form of payment for increased hospitalizations, higher critical care costs, and substantial end-of-life costs.
It is our strong recommendation that CMS consider providing coverage for the patients with which the national coverage policy was written, including patients who suffer from PF.
Sincerely, The Coalition for Pulmonary Fibrosis
Top Pulmonary Fibrosis Experts Who Join the CPF in making these comments:Marvin Schwarz, MD, James C. Campbell Professor of Medicine University of Colorado Health Sciences CenterJames Loyd, MD, Medical Co-Director, Lung Transplant Program Medical Co-Director, FLOLAN Program for Primary Pulmonary Hypertension, Vanderbilt University Medical CenterAdaani Frost, MD, Professor of Medicine, Baylor College of MedicinePaul Noble, MD, Professor of Medicine Division Chief, Allergy & Critical Care Medicine, Duke University Medical CenterGlenn Rosen, MD, Associate Professor of Medicine, Division of Pulmonary & Critical CareCo-Director, Stanford University Lung Disease Center, Stanford Medical Center Marilyn Glassberg, MD, Assistant Professor of Medicine, Division of Pulmonary & Critical Care Medicine, University of Miami/Jackson Memorial Medical CenterJeffrey Golden, MD, Medical Director, Lung Transplantation Director, Interstitial Lung Disease Clinic University of California, San FranciscoHarold Collard, MD, Assistant Clinical Professor of MedicineDirector, Interstitial Lung Disease Program Division of Pulmonary and Critical Care Medicine, University of California, San FranciscoStephen Nathan, MD, Medical Director, Lung Transplant & Advanced Lung Disease Programs, Inova Fairfax HospitalMaria Padilla, MD, Associate Professor of Medicine Director of the Advanced Lung Disease Program, Mt. Sinai Medical CenterGanesh Raghu, MD, Professor of Medicine, University of Washington, Chief of Chest ClinicDirector, Lung Transplant Program and Interstitial Lung Disease Program University of Washington Medical CenterFernando Martinez, MD, Associate Professor, Division of Pulmonary and Critical Care MedicineDirector, Lung Volume Reduction Program, Medical Director, Pulmonary Diagnostic Services University of Michigan Medical Center
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