Research is fine, but it has to be the right research if we are to combat effectively the challenges that plague the HME industry.

Despite successes with lobbying efforts by industry advocacy groups, the HME industry faces perpetual challenges from policy makers. Two important bills have been sponsored to mitigate the challenges, but it is unlikely that they will be successful in the House of Representatives and the Senate, and it is virtually assured they will not be signed by the President during the 110th Congress.

HR 621, the Home Oxygen Patient Protection Act (HOPPA)—introduced by Representative Tom Price, MD (R-Ga)—and HR 1845, the Medicare Durable Medical Equipment Access Act of 2007—introduced by Representatives John Tanner (D-Tenn) and David Hobson (R-Ohio)—resulted from advocacy efforts to change the framework of the current laws. However, the industry must create lasting solutions that withstand the test of time.

Many discussions have addressed the development of a comprehensive data management process for the industry, yet not much has been done to date. We have accomplished a lot as an industry through the development of research position papers, but more must be done if we are to get policy makers and CMS officials to recognize the industry as an essential part of the health care continuum.

To quantify effectively the economic and health care outcomes that demonstrate the value of the home care/HME industry, we need credible data-collection tools that have been validated by independent government organizations such as the Agency for Healthcare Research and Quality (AHRQ) or Evidence-Based Practice Centers (EPCs). The resources that have been invested in developing position papers and reports would be used served by investing in long-term solutions.

White papers, position statements, industry-sponsored research, and anecdotes are the worst forms of evidence. CMS bases its reimbursement decisions on statistically valid evidence, and the best evidence comes from valid tools and, ultimately, synthesized data with reliable conclusions. Albert Einstein once said, "The definition of insanity is doing the same thing over and over again and expecting different results." The original quote came from Benjamin Franklin.

Now we don't dare make the leap that our efforts are insane, but you have to admit that it truly does feel like an exercise in futility. There have been fragmented efforts to quantify data, yet they are not enough to get us to a point of respectability as an industry. We have the right idea; however, we must create long-term solutions that establish the validity and reliability of the conclusions.

CREDIBLE RESEARCH AND LONG-TERM EFFECTIVENESS

The Nocturnal Oxygen Therapy Trial (or NOTT—evidence-based research) and the general consensus of the home care industry (subjective expert experience) established oxygen as the only treatment modality proven to benefit patients diagnosed with chronic pulmonary conditions. The research concluded that patients whose blood oxygen levels fell below a set point should be provided supplemental oxygen. The NOTT study was published in 1980, and the data was collected in the late 1970s. No additional research has been conducted since NOTT regarding oxygen therapy, yet the conclusions have withstood the test of time and, more importantly, changes in Congress.

We have fallen short in furthering the research to establish the need for the clinical services associated with the delivery of supplemental oxygen. Furthermore, we have failed in demonstrating the evidence basis for the services to prevent complications associated with desaturations when a patient does not receive adequate oxygen. As a result, we are faced with decisions made by CMS that potentially could have been avoided if we had invested resources in creating a lasting process when we first began discussing the need to do so 5 or so years ago. However, despite the lack of reimbursement for the services associated with supplemental oxygen, the NOTT results continue to support its benefits—thus, it is unlikely that coverage for oxygen will go away.

CPAP COMPLIANCE MONITORING: A PERFECT EXAMPLE

Vernon R. Pertelle

Unlike supplemental oxygen services, we have gained support for the services associated with treating patients requiring continuous positive airway pressure (CPAP). Contrary to the oxygen example, we were effective in demonstrating the need for services associated with monitoring treatment for patients diagnosed with obstructive sleep apnea (OSA). Through the use of evidence-based data, we convinced policy makers of the need for compliance monitoring and appropriate reimbursement to prevent comorbid complications (and the resultant increase in health care costs).

The focus for coverage centered on patients, their disease, and related co-morbid complications when left untreated. Patients were at the center of the discussion, and the data focused on health care outcomes—the patients felt well when they adhered to therapy—and potential reductions in health care expenses (economic outcomes) when patients adhered to therapy.

The HME industry's focus must be on meeting the needs of patients. In meeting the needs of patients, quality improves. As quality improves, health care costs are reduced. This is proven in the literature and always results in reimbursement to facilitate quality and performance improvement—the very basis for pay-for-performance.

Robert McCoy

Typically, our industry has not typically placed the clinical focus first and foremost—thus, the dilemma we face in trying to demonstrate benefits from services today. Instead, in many cases the focus was on profit margins. To change the approach, we need support from all clinical associations to accomplish a patient-centered focus.

One such example to support a collaborative patient-centered focus was with the long-term oxygen therapy (LTOT) conferences, in which we made six unsuccessful attempts to address overall needs of patients in all aspects from appropriate equipment and education to reimbursement—yet could not establish a consensus due to lack of agreement among participants. This disagreement prevented the unified approach to creating multiple solutions.

The most recent LTOT conference was patient-centered and facilitated a greater understanding of all participants regarding the services offered by HME providers—including patient education, need for coverage regarding respiratory therapist services, and equipment selection to meet specific patient needs. However, not much has been done as a follow-up to the recommendations.

For more articles on oxygen/respiratory therapy, visit the free archives. In the archives, you'll find a knowledge database including articles such as: May 2007 Elevate the Evidence "We are sending lobbyists to Capitol Hill unarmed." By Robert McCoy, RRT March 2006 Who Needs Portable Oxygen? COPD patients need long-term oxygen therapy, but evidence for determining the best system is still lacking. By Vernon R. Pertelle, MBA, RRT, and Jim Dudley, RRT

We must establish rock-solid data on the application, use, and value of LTOT from a clinical perspective—and demonstrate how the services are absolutely essential to the success of therapy, health outcomes, and savings.

Historically, survival was the key outcome measurement. This is an important end point; however, in addition to survival, we need to demonstrate how surviving patients consume fewer health care dollars by staying out of the hospital. Each of these outcomes is measurable, and evidence showing benefit is a more compelling argument for the industry during discussions with policy makers.

If we can establish irrefutable evidence that providing LTOT and clinical services improves health outcomes while saving dollars, the industry will be in a much better position with policy makers and decreases in reimbursement will be eliminated. Unfortunately, the efforts thus far have been ineffective to prevent reimbursement cuts, and the industry as a whole remains "fair game" when looking for reductions.

We have fallen short for two decades, and payments for LTOT have been cut 50% during that time. Now it is time to change our approach and look for lasting solutions to the problems that plague the industry.

Vernon R. Pertelle, MBA, RRT, is assistant vice president of the Tri-City health care district in San Diego. Robert McCoy, RRT, FAARC, is managing director, Valley Inspired Products Inc, Apple Valley, Minn. He can be reached at .