Association for Applied Psychophysiology
And Biofeedback

10200 W. 44^th Street, Suite 304 Wheat Ridge, Colorado 80033-2840

Tel: (303) 422-8436 Fax: (303) 422-8894 E-mail: aapb@resourcenter.com

December 20, 1999

Ms. Constance A. Conrad, Executive Secretary

Medicare Coverage Advisory Committee

Health Care Financing Administration

7500 Security Boulevard

Mail Stop S3-02-01

Baltimore, MD 21244

Dear Ms. Conrad:

The Association for Applied Psychophysiology and Biofeedback (AAPB) wishes to submit this letter and its attachments for the consideration by the members of the Medicare Coverage Advisory Committee considering Medicare reimburse for biofeedback in the treatment of incontinence.

AAPB is concerned about the current direction being taken by HCFA. We note that the minutes of the May 6-7, 1997 TAC committee concluded:

There was general agreement that biofeedback for headaches and urinary incontinence are the biggest biofeedback issues and that HCFA should request an assessment of biofeedback's effectiveness for these indications.

We are concerned that HCFA's MCAC has changed the agenda from "biofeedback" to "incontinence", and that "electrical stimulation", which was not even mentioned in the 1997 TAC minutes, has now become an equal topic with biofeedback.

We wish to point out that, in spite of certain superficial similarities, there are fundamental differences between biofeedback and electrical stimulation. Some of these differences bear closer examination. While we have no objection to Medicare reimbursement for electrical stimulation, we believe that it should be kept a very separate discussion from the issue of reimbursement for biofeedback. Our reasons for this are stated below.

1. The Mechanisms of Operation are completely different.

At first glance there is a similarity between biofeedback devices (at least those made for home training) and electrical stimulation devices. Both use small boxes containing electronic parts, connecting cables, and insertable vaginal or anal sensors. But the similarity is only superficial and the electronics are really quite different. In biofeedback, all electrical currents travel away from the patient into the box. In electrical stimulation, all electrical currents travel from the box into the patient. This fundamental difference is reflected in the topics that follow.

2. Clinician Education, Training and Investment are very different.

Biofeedback has a long and rich history of encouraging practitioners to undertake extensive theoretical and hands-on training to become qualified to offer services to the public. The highest standard is "Certification in Biofeedback" by the Biofeedback Certification Institute of America (BCIA). Many physicians, psychologists, nurses, physical therapists, and clinical social workers have earned this distinction. Many organizations offer Biofeedback Training programs, of weekend-to-weeklong duration, as an alternative to full certification, or as a stepping-stone towards that goal.

Effective use of biofeedback requires skill not only in instrument operation, but also in patient education and methods of patient motivation.

In contrast, there is no "certification" in electrical stimulation, and no formal training is offered beyond brief mention at professional conventions. At best, instrument salesman offer brief instruction in following the printed directions that come with the device. No special training of the clinician is even necessary, because the "clinician" does not really "do" anything; the stimulator device does all the work, according to the theory.

Other than attaching the electrodes as shown in the manual, and setting the device parameters as explained there, virtually no operator skill or talent is required to dispense electrical stimulation devices. (Magnetically-coupled stimulators are considerably more complex, of course, but automated, so clinician skill is still considerably less than for biofeedback.)

In addition, the clinician's investment in clinical (office) instrumentation for biofeedback is considerably greater. Basic costs range from $3,000 to $15,000, depending on the complexity (and analytical power) of the device. There are no comparable clinician capital expenses in the field of electrical stimulation.

3. Finally there are significant and substantial differences in the clinical outcomes for electrical stimulation vs. biofeedback.

Electrical stimulation research has a considerably poorer track record than biofeedback. While the range of results is almost overlapping, the overwhelming majority of electrical stimulation studies achieve considerably less symptom reduction than biofeedback. One average, biofeedback is about twice as effective in a quarter the time.

Documentation of this difference requires only two observations. First, proponents of electrical stimulation obscure major differences by publishing only vague "patient improvement rates", often in the 75-85% range, which are mistakenly compared with "symptom reduction rates" made popular by Dr. Kathryn Burgio's biofeedback research. In fact, these two methods of reporting results are very different. To cite but one current example, the "Neocontrol" website boasts "83 percent reported 'significant improvement'" in a recent study. But their own data, from the 1999 AUA convention, shows "66 percent" patient improvement rate, but only a 48 percent "symptom reduction rate" (3.3 leaks per day before, 1.7 after). In addition, we note that 1.7 leaks per day "after" is still classified by the International Continence Society as "incontinent". Similar observations may be made of most other electrical stimulation research.

Second, the record for biofeedback is considerably better than academic critics, such as in the Monaco Report of 1998, like to pretend. In contrast, the AAPB recognizes the importance and validity of "clinical series" research, such as the NIA-funded studies by Dr. Burgio, which typically show 85-95 percent symptom reduction rates. Dr. Burgio has presented her research at the annual meeting of the AAPB, and has published in the most respected journals, including JAMA.

There is a strong tradition in "academic" research that emphasizes the importance of randomized controlled trials. Unfortunately, this often results in careful attention to the "external" elements of RCTs, but with little concern for the quality of the treatment provided within the "cells". In behavioral therapies, as in surgery, and unlike pharmacologic research, the quality of the therapy is very dependant on the skills and training of the therapist. To cite but one example, in the largest, most expensive RCT of biofeedback to date (Burns, 1993), the therapist had neither certification nor formal training in biofeedback, and failed to follow many of the manufacturer's recommendations for the device she was using. In contrast, Burgio et al (in several studies) did not use RCTs, but followed sound principles of biofeedback training. She obtained 50% better results than Burns (90% +/-5% vs. 61% symptom reduction rate).

AAPB believes that precious national resources should be targeted for therapies that are the most effective, for the greatest cost savings in both the short and long term.

Attached are two documents. The first is a commentary on the electrical stimulation utilization parameters submitted by representatives of the nursing profession. It speaks for itself.

The second is an essay by long-time AAPB member Dr. John Perry, which will be published in the March 2000 issue of our quarterly newsmagazine, "Biofeedback". Dr. Perry has played a major role in the development of EMG biofeedback for the treatment of incontinence, beginning in 1978.

We, the Board of Directors of the AAPB, commend this letter and these attachments to your thoughtful consideration. If you have any questions or comments, you may address them to me at any time, or to our representative who has already request permission to address your public hearings on our behalf in January.

Respectfully submitted,

Francine Butler, PhD

Executive Director, AAPB

Enclosures:

1. Commentary on "Continence Coalition's Electrical Stimulation Utilization Parameters."

2. Article: "Is Electrical Stimulation a Drug?"