Translating Research Into Practice

Alarm Rings in Lousiana—Time for the Profession to Wake Up An Open Letter to Chiropractic From FCER President, Charles Herring, DC With the closing of the Louisiana legislative session it became even more apparent to me that the external influences on the chiropractic profession (and healthcare in general) are moving—in a very organized fashion—to use the literature (or the lack thereof) to make decisions regarding payment policies of the insurance industry (both health and workers’ compensation insurance). During the recent Louisiana legislative session it was learned that the National Insurance Commissioners Association has written a model piece of legislation. A major part of this legislation addresses the issue of denying care based on evidence or the lack of evidence. This model legislation is occurring because state legislatures have passed “Medical Necessity Review Organization laws” that limit the ability of the insurance companies to deny care on the basis of medical necessity. To combat these limits, the proposed bill would legally permit the insurance companies to stop denying care because it is not medically necessary and begin denying care on the basis that it is “observational and investigational.” They are attempting to change the rules of the game and will now deny claims because there is no evidence to support the effectiveness of a particular treatment. Methods to The Madness • For quite some time, health insurance has talked about “evidence-based practice,” but they have not actually done much to create standards and enforce the concepts of “Best Practices.” Medical necessity is routinely based on the demonstrated needs of the patient and the documented demonstration of a condition and the response to the treatment being rendered. The treatment rendered and the need for future care was then addressed by a consultant at the point of pre-certification. United Healthcare and ACN have typically used standards that they created from what they perceive to be the evidence-based treatment protocols in the literature. • The “length of care” determination has been arbitrary at best and is predominantly determined by the use of data comparisons with other chiropractors in the network. They have also used other outcome measures which may not address the specific problems of the patient that you are treating. • Until recently, the insurance companies deny payment for recently developed therapies—such as VAX-D and Low Level Laser—by making the determination that these new therapies are considered “observation and investigational.” The result is that all new technologies are being measured by the evidence that is available. In making these determinations, the required level of evidence has been high quality randomized controlled trials. • Many private insurance companies will not pay for cervical disc replacement with the new disc that allows movement of the motion unit. While a study of the disc approved by the FDA resulted in the approval of the device, the insurance companies have refused payment because the patients were not randomized, the treatment was not blinded, and the study did not compare the new treatment to a placebo. • Learning from their success with not paying for new therapies, health insurance companies are now creating policy language to limit payment for various long-standing, well-established treatments in chiropractic such as massage and various electrical modalities. Aetna now has a “clinical policy bulletin” that specifically addresses chiropractic care. This policy bulletin states that they will not pay for the treatment of scoliosis except during early adolescence. There are also a number of techniques that are not covered. This is all being denied because there is no evidence that the treatment is effective and therefore the treatment is considered “observational and investigational.” • Workers’ compensation insurance and business interests are now pushing very hard to pass legislation that will require the use of treatment guidelines in the treatment of injured workers. The Workers Compensation Research Institute (WCRI) has been providing data analysis reports of workers’ compensation costs in numerous states. Their reports have targeted medical cost and have suggested that certain treatments are major cost drivers—with chiropractic care being list at or near the top of the list. The insurance industry and business groups have also heard about the implementation of the American College of Occupational and Environmental Medicine (ACOEM) guidelines in California. They have been told that medical costs have significantly decreased since ACOEM guidelines were mandated by law in California. Guidelines only use the highest level of evidence—RCTs or systematic reviews that are based on RCTs. These two situations are creating and will continue to create great difficulties for the chiropractic clinician. • Our first problem is our lack of evidence. While there is a body of evidence that supports the major conditions that chiropractors treat, most of the evidence is not rated at the highest quality because it is difficult to blind the patient or the doctor and it is difficult to do a treatment comparison with a placebo or sham treatment. This affects the quality of the RCTs that have been done and thus weakens our argument that spinal manipulation is effective. • Other treatments, such as therapeutic modalities, have been tested and have been found to be ineffective within the standard RCT model of research. For example, electrical stimulation has been tested alone, in conjunction with spinal manipulation, and spinal manipulation alone in a single study. This study found that there were no prolonged treatment effects of electrical stimulation when performed alone or in conjunction with spinal manipulation at 30 days, 90 days, 6 months, and 12 months. Spinal manipulation was just as effective with and without electrical stimulation. I think we would all agree that there are no long-term therapeutic benefits to the administration of electrical stimulation. The research design prohibits a successful outcome because electrical stimulation was never intended to have long-term effectiveness. The effects on pain and spasm have shorter-term therapeutic benefits, but the studies do not measure the effectiveness with the context of how it is used in clinical practice thus the studies report that it is ineffective. Now the insurance industry says... “There are no studies to support the effectiveness of this treatment.” • Finally there is increasing competition between the chiropractic profession and the physical therapists. They have established doctoral programs and are doing a significant amount of research in universities. There is even talk in Washington that chiropractic should be considered a subset of physical therapy since PTs are more integrated into the education system and the medical treatment model. We are currently in a race to have cultural authority over manipulation, but when it comes to research to support this authoritative position we are losing the race. Meeting the Challenges Ahead What must our profession do? 1. We MUST fund research like our livelihoods depend on it—because they do. New studies are needed to demonstrate the benefits of chiropractic care with the public, government, and payers of healthcare services. Our lack of evidence is going to allow the insurance industry to continue to deny more and more treatments provided by the chiropractic profession. FCER is setting up practice-based research programs to create clinical data that can then be leveraged into Federal grants to do major research projects through our colleges and other institutions. FCER will need to fund small studies that can be used to obtain Federal grants. State associations will need to step up and support this effort and individual DCs will be needed to participate in these studies. 2. DCs MUST learn how to find, read, interpret, and apply evidence in their practices. We can no longer afford to do things just because BJ said it. We must be able to use evidence to guide our decisions with regard to the treatment of our patients. Society is now demanding that doctors practice in an evidence-based manner. The chiropractic profession must embrace this approach to providing care if we hope to participate in future government programs, insurance programs, workers’ compensation, as well as developing closer working relationships with the medical profession. Even public acceptance hangs in the balance. 3. We MUST fund programs that have the potential for developing more evidence and for training the profession to use evidence in practice. FCER must be funded at the level necessary to meet the professions needs both now and in the future. We do not have the benefit of outsiders who will foot the bill for us. We must look to ourselves for the major financial assistance that is needed. The time for us to act is NOW. We cannot wait any longer. Further delays will only result in our profession falling farther and farther behind in the evidence-based world. Please support FCER today and give on a continuing basis. Research evidence is the foundation for inclusion of chiropractic care in all programs. The responsibility for our profession falls on you as it falls on me; we can not rely on “them.” As the chiropractic profession’s oldest not-for-profit foundation, serving the profession since 1944, FCER is charged solely with providing the chiropractic profession with the research tools to battle exactly these challenges—and the Foundation is funded entirely by those within the chiropractic profession. FCER, based in Norwalk, Iowa, has as its mission to “Translate Research into Practice” by granting funds for research and producing practitioner and patient education materials including teleconferences, CDs, books and pamphlets. FCER is developing the profession’s only Evidence-Based Resource Center at www.DCConsult.com. More information on FCER, membership, and subscriptions to DCConsult can be found at www.fcer.org or by calling 515-981-9888.