Almudena Sunset

Over the past 40 years or so, more and more studies—many peer reviewed and well designed—showing that pulmonary rehabilitation (PR) really does work have been published. It improves the patient’s quality of life. It reduces exacerbations and hospitalizations.

The just-released “Evidence-Based Clinical Practice Guidelines”1 is an objective review of the recent scientific literature and a series of recommendations supported by that evidence. “There is substantial new evidence that pulmonary rehabilitation is beneficial for patients with COPD and other chronic lung diseases.”1 We now have a body of scientific knowledge that validates what has become recognized as the standard of care for victims of chronic lung diseases—pulmonary rehabilitation.

In the 1950s and 1960s, the increase in lung disease was already being noticed. Back then, even without solid evidence, many physicians and researchers had already identified tobacco, correctly, as the culprit. More and more patients with chronic lung disease, recognized primarily as emphysema, were showing up at their doctors’ offices. Emergency department visits and hospitalizations were on the rise.

Patients with emphysema could expect to be told something like this: “You have bad lung disease, and there is not much we can do for you. You shouldn’t do anything that makes you short of breath. Exercise is out of the question.”

The unstated message to the patients was this: “All hope is lost. You might as well make out your will; then just go home and sit on the couch until you die.”

That was simply not acceptable. It was not acceptable treatment of our patients, and it was not an ethically acceptable position for health care professionals.

In the late 1960s, Tom Petty, MD, and others began writing and talking about the benefits of keeping patients with chronic obstructive pulmonary disease active and ambulatory. They suggested unheard-of things, such as ambulatory oxygen2 and even exercise.3 Much of that early work was guided by anecdotal observation.

“Listen to your patient; when in doubt, look at the patient.” We all heard words like these from our clinical instructors. That is exactly what the pulmonary rehabilitation pioneers did. They recognized that patients wanted to be active, and that being active—yes, even exercising—improved their conditions.4

Does Pulmonary Rehabilitation Improve HRQOL?

Yes! A resounding yes. “Pulmonary rehabilitation improves health-related quality of life [HRQOL] in patients with COPD.”1 This statement was given the highest possible rating, 1A (high strength of evidence and benefits outweigh risks/burdens) in the new “Evidence-Based Clinical Practice Guidelines.” No less than 15 studies, all of which were well designed with high-quality data, point to improvement in a patient’s HRQOL following participation in a pulmonary rehabilitation program.

Other Benefits

The new guidelines go on to cite evidence that “Pulmonary rehabilitation reduces the number of hospital days and other measures of health care utilization in patients with COPD.”1 In other words, besides making patients feel better, PR saves the health care system money. And we’re talking big money! Todd Lee, MD, presented a study at the 2006 American Thoracic Society (ATS) convention in San Diego that stated that over the next 20 years, costs related to COPD will total approximately $832.9 billion in the United States.5

Evidence also shows that pulmonary rehabilitation patients enjoy psychosocial improvements and that patients with respiratory diseases other than COPD can benefit. Pulmonary rehabilitation should be a “win-win.” Respiratory patients improve and the health care system saves money.

Legislation Proposed

Health care professionals working in pulmonary rehabilitation and cardiac rehabilitation have long understood the need to secure recognition and reimbursement for the services they provide. Three years ago, a number of professional organizations representing the pulmonary rehabilitation community (American Association of Cardiovascular and Pulmonary Rehabilitation [AACVPR], American Thoracic Society, American College of Chest Physicians [ACCP], National Association for Medical Direction of Respiratory Care [NAMDRC], and the American Hospital Association [AHA]) came together to create legislation that would amend the Medicare statute to provide legal recognition of both pulmonary rehabilitation and cardiac rehabilitation.

In its current form, the Pulmonary and Cardiac Rehabilitation Act of 2007 is known as HR 552 in the House of Representatives and as S 329 in the Senate. As of this writing, this legislation has 120 House cosponsors and 31 Senate cosponsors.

In other words, HR 552/S 329 is showing significant legislative strength. Unfortunately, Congress has many issues to deal with, and there is no guarantee that our legislation will pass.

Cloudy Future

In September 2006, the Centers for Medicare and Medicaid Services (CMS) began implementing major changes in how Medicare claims are processed. The mandate for these changes actually comes from the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).6

In the past, Medicare billing claims for services such as pulmonary rehabilitation were processed by Fiscal Intermediaries (FIs). The FIs were actually large insurance companies that contracted with Medicare. There was a large number of FIs covering geographically scattered areas across the United States.

The MMA mandates the creation of Medicare Administrative Contractors (MACs) to replace the FIs. The MACs will be fewer in number and will cover much larger consolidated geographic areas.

Here is the problem: Most of the FIs had developed their own guidelines (known as a Local Coverage Determination or LCD) for the billing and reimbursement of pulmonary rehabilitation. The new MACs do not have any such guidance in place and show no inclination to develop LCDs.

Gathering Storm

For many years, the AACVPR, ATS, ACCP, NAMDRC, American Association for Respiratory Care, and AHA have been asking CMS to provide recognition for pulmonary rehabilitation services in order to establish the basis for reimbursement. A coalition of these professional groups has repeatedly asked CMS to issue a National Coverage Determination (NCD) to formalize that recognition.

CMS has finally responded. On June 27, 2007, CMS published on its Web site the “Proposed Decision Memo for Pulmonary Rehabilitation (CAG-00356N).”7 It reads, in part: “that 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.”

This 26-page document references many studies, some of which I have cited in this article. With few exceptions, this scientific literature supports the fact that pulmonary rehabilitation does benefit patients with chronic respiratory disease. And yet we still have no NCD!

Other Storm Warnings

The Deficit Reduction Act of 2005 set in motion CMS regulations that are usually referred to as oxygen caps. These regulations will make the home oxygen patient the owner of the oxygen equipment provided to them and will make the patient responsible for repair or replacement of that equipment after 36 months. The 36-month clock started running in January 2006.

The following “perfect storm” elements are coming together and are about to hit pulmonary rehabilitation:

  • CMS has just turned thumbs down on a National Coverage Determination for pulmonary rehabilitation (in spite of the overwhelming evidence of benefits).
  • The Fiscal Intermediary to Medicare Administrative Contractor transition will take place over the next 18 months, and without an NCD, the new MACs will be free to reduce or eliminate reimbursement for pulmonary rehabilitation (some already have).
  • The legislation that will help straighten this out, HR 552/
  • S 329, is not likely to get passed this year, and since 2008 is a presidential election year, that means the legislation will most likely be delayed until the next Congress beginning in 2009.
  • Oxygen caps and competitive bidding are going to reduce the availability of ambulatory O2 systems such as the Helios (back to E cylinders).
  • Add to all this the fact that the Baby Boom generation, with a large percent of COPD patients, is now coming up to Medicare age.

In recognition of the impossible burden this placed upon the home oxygen patient, CMS has made limited regulatory changes to provide for some repair and maintenance of home oxygen equipment provided under Medicare. However, the problems remain far from solved.

Oxygen competitive bidding is another very troubling problem. CMS is moving forward with competitive bidding among the oxygen providers. While this may sound like a good idea on the surface, it is having the effect of reducing the ability of durable medical equipment providers to offer the newer, lightweight, ambulatory oxygen systems to their patients.

Could This Become Pulmonary Rehabilitation’s Perfect Storm?

Our COPD and other chronic respiratory disease patients will be flooding the physician’s offices, emergency departments, intensive care units, and skilled nursing facilities because the PR that they need and the ambulatory O2 systems that they need are not there!

Conclusions

Today, pulmonary rehabilitation truly has become the standard of care. The evidence is overwhelming; both patients and the health care system enjoy the many benefits.

In spite of this, many serious and threatening problems remain. The next few months will see pulmonary rehabilitation weathering a significant storm. Much depends on how we handle it. Respiratory care professionals will need to prepare by being informed and work hard to survive.

Support the legislative efforts to help our patients. Talk to your patients, your colleagues, and your administrators. Make sure they are aware of the problems and the solutions.

Let’s hope that after the storm, we will again have clear skies and sunny days.

Carl Willoughby, RRT, RCP, is pulmonary rehabilitation coordinator, Mad River Community Hospital, Arcata, Calif. For further information, contact [email protected]

References

  1. Ries AL, Bauldoff GS, Carlin BW, et al. Pulmonary Rehabilitation: Joint American College of Chest Physicians/American Association of Cardiovascular and Pulmonary Rehabilitation Evidence-Based Clinical Practice Guidelines. Chest. 2007;131:4S-42S.
  2. Barach AL. Ambulatory oxygen therapy: oxygen inhalation at home and out of doors. Dis Chest. 1959;35:229.
  3. Petty TL. Ambulatory care for emphysema and chronic bronchitis. Chest. 1970;58:441.
  4. Miller WF. Rehabilitation of patients with chronic obstructive lung disease. Med Clin North Am. 1967;51:349.
  5. Buist AS, Vollmer WM, Sullivan SD, et al. The Burden of Obstructive Lung Disease Initiative (BOLD). COPD. 2005;2:277-83.
  6. CMS. Part A/Part B Medicare Administrative Contractor. Available at: www.cms.hhs.gov/MedicareContractingReform…#TopOfPage. Accessed June 30, 2007.
  7. CMS Proposed Decision Memo for Pulmonary Rehabilitation (CAG-00356N). Available at: www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=199. Accessed June 28, 2007.