Re: Biofeedback Treatment of Incontinence:
If the rejection was based of an "insurance benefit claim", substitute the appropriate terms for "preauthorization review" below.
Likewise, substitute specific topics as appropriate where ever brackets [ ] are shown below.
Attach a copy of Dr. Perry's position paper (following this), perhaps highlighting sections or sentences you think are important or relevant. Or cut and paste and re-number the sections as needed.
Permission to photocopy and use the following material is hereby granted, provided that a copy of your actual letter is sent to Dr. Perry at the address below. (He would also appreciate receiving a copy of the "reject" letter you got, so he can track the insurance industry's attempts to avoid responsibility for this treatment.)
Additional Tips for Dealing with Insurance Rejects.
1. Whenever possible, call the person who wrote the reject letter and try to figure out exactly what they thought they were rejecting, and how they came to their conclusion. (Don't argue with them for now; your appeal will have to come in writing anyway). Most rejects are form letters which don't really convey the reviewer's thought processes clearly.
2. Don't get discouraged. Many initial rejects are overturned on appeal.
3. If you come up with new problems that aren't covered in these materials, contact Dr. Perry directly; he may be willing to write a special letter for you.
Send to: Dr. John D. Perry, PhD 3620 Sunrise Drive Key West, Florida 33040 USA Phone: 305-294-4688 Fax: 305-294-5115 or, better, email: DrPerry@incontinet.com.
(If in the future the above address is invalid, call 1-800-JD-PERRY (the National PerryMeter Home Trainer Rental Program) to find Dr. Perry's current address.)
NAME OF PRACTICE
ADDRESS OF PRACTICE
CITY, STATE, ZIPCODE
TELPHONE & FAX NUMBERS
[Date]
[Utilization Management Supervisor Name]
[Insurance Company Name ]
[Mailing Address]
[City-State-Zipcode]
Re: Patient: [Patient's Name & SS Number]
Subscriber: [Subscriber's Name & ID Number]
Dear [Utilization Management Supervisor Name]:
On [Date] I submitted a pre-authorization review request on behalf of the above named patient for treatment of [Name of Condition/Diagnosis and IDC-9 number] using the [Orion/Perry Pelvic Muscle Rehabilitation program and system manufactured by Self Regulation Systems, Redmond, Washington.] The "medical necessity" for this treatment has already been established by the written referral of this patient for this therapy by [Name and City of Physician,] [a photocopy of which is attached.]
In your rejection letter dated [Date of reject] you stated the following reason(s) for rejection: (1) You claim that the procedures were "experimental" and/or "investigational"; (2) you claim the procedures "have not been proved effective"; (3) you claim the procedures are not generally accepted as a standard of good medical practice; and (4) you claimed that physical therapists [nurses] are not qualified to perform this procedure.
Your conclusions are probably based on certain out-of-date position papers, and they are not correct. Therefore, your rejection is hereby being appealed.
In support of this appeal, I submit the enclosed position paper written by Dr. John D. Perry, on my behalf. Dr. Perry is the inventor of the electromyographic pelvic muscle sensors, and of the original therapeutic techniques which we used [proposed to use] for [Patient's Name]'s treatment. I especially call your attention to sections: [(1) Is EMG biofeedback for incontinence "experimental" or "investigational"?; (2) Have EMG techniques been proven "effective"?; (3) Is EMG biofeedback generally accepted as a standard of good medical practice?; (4) Who is qualified to perform EMG biofeedback for incontinence?; and (5) Aren't 'Kegel Exercises' routinely taught by Nurses?]
My patient, [Patient name] and I look forward to an early and positive response to this appeal.
Very Truly yours,
Signature (etc).
.............................(Following is the supporting essay to include or exerpt from:)
By John D. Perry, M.Div., Ph.D., F.A.A.C.S.
President, PerryMeter™ Systems
© 1994 John D. Perry - All Rights Reserved
Q1. Is EMG Biofeedback for incontinence considered "experimental" or "investigational"?
A1. No. It is the responsibility of the U.S. Food and Drug Administration (FDA) to decide if a new medical device is considered "experimental" or "investigational", and if it is so determined, the device cannot be sold without following detailed procedures; it must be labeled "CAUTION - Investigational Device. Limited by U.S. Law to Investigational Use". No such restrictions were required for these devices.
In its most recent "510(k)" notification, our company included as part of the "required labeling" the following statement of purpose:
"The Single-User Perineometer is designed to provide electromyographic ("EMG") biofeedback from the pelvic musculature for the purpose of rehabilitation of weak pelvic muscles and the restoration of neuromuscular control. These sensors are widely used in the biofeedback treatment of urinary and fecal incontinence, for pelvic pain due to muscular tension, and for certain sexual dysfunctions caused by muscular weakness or tension"
By letter dated July 26, 1991, the FDA notified the undersigned that "we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976 ... You may, therefore, market the device ... subject [only] to the general controls provisions of the Federal Food, Drug, and Cosmetic Act." Note that no "investigational" or "experimental" requirements were imposed.
At the request of the FDA, at the time of our 1986 510(k) notification, we included in our labeling the fact that our sensors must be used with "high quality" EMG instruments [as distinguished from "toy" and "hobby" devices]. All of the currently available clinical EMG instruments, such as SRS Orion, Hollister InCare, Though Technology, J&J, etc. meet this technical requirement. In addition, they are themselves regulated by the FDA and are required to file 510(k) notices.
Therefore, these sensors and related instruments cannot legally be considered or described as "experimental" or "investigational" when they are used in accord with the "FDA labeling"; namely, for rehabilitation of weak muscles (as in the treatment of urinary or fecal incontinence), or restoration of neuromuscular control (as in urinary dyssynergia and functional constipation), or pelvic pain (such as levator syndrome, dysmenorrhea, interstitial cystitis, vulvar vestibulitis, etc.) or sexual dysfunctions (including orgasmic difficulties when caused by muscle atrophy, and vaginismus when caused by muscle control problems).
Q2. Has EMG Biofeedback of Pelvic Muscle function been proven effective in the treatment of Urinary and Fecal Incontinence?
A2. Yes. The most recent and also the most comprehensive review of the efficacy of pelvic muscle exercise methods for treatment of urinary incontinence was published in the 1992 AHCPR Guidelines (discussed more completely in the next "Question".) The Guidelines, based on extensive literature review by a large panel of experts) conclude that these methods are 87% effective (patients cured or improved, no side effects or complications), compared with 83-88% for surgery (with 20% complications).
When PerryVaginal™ and PerryAnal™ sensors were introduced in 1980, PerryMeter Systems was not required to prove efficacy, since the FDA ruled our devices were "substantially equivalent" to the original Kegel (manometric) Perineometer (marketed from 1948 to 1979). Dr. Arnold Kegel published many papers describing an overall 93% success rate based on over 3,000 patients who used his perineometer daily in treatment of urinary stress incontinence.
In the late 1970's Dr. William Whitehead and colleagues at Johns Hopkins successfully applied Kegel's manometric biofeedback to the treatment of fecal incontinence, especially among the elderly and children with spina bifida. In the early 1980's Dr. Katherine Burgio and colleagues extended these NIA-funded studies to include the treatment of Urinary Incontinence by manometric methods. Over all, NIA-manometric studies, which are generally limited to four or five biofeedback sessions, achieve 75 to 94% success rate [defined as percentage of symptom reduction after treatment] in the treatment of urinary or fecal incontinence.
The first major (federally-funded) project to replicate Kegel's work with the EMG-type perineometer was published by Dr. Patricia Burns et al. Using a fixed number of sessions (8) and (like the NIA studies) no "home trainers" for home practice, she was nevertheless able to show significant improvement (greater than 61% symptom reduction) in the biofeedback group, compared with control groups. Subsequently, a University of Pennsylvania-New Jersey Dept of Health project showed that 77% symptom reduction could be obtained with weekly in-clinic EMG biofeedback (and limited use of EMG home trainers-typically only for the first week or two). Perry & Hullett reviewed 14 studies showing biofeedback treatments for incontinence; those without home trainers produced success rates (percentage of symptom reduction) of 70 to 94%, while those using home trainers obtained 87 to 100% reductions.
In evaluating the effectiveness of EMG biofeedback for treating incontinence, it is important to make appropriate comparisons. Although surgeons boast of cure rates in the upper 90% range for their techniques, impartial observers suggest lower figures. For example, the AHCPR put surgery on the same level as behavioral methods (but with significantly higher complications rate), and the highly esteemed Kristene E. Whitmore, MD, Chairman of Urology at Graduate Hospital in Philadelphia, estimates that incontinence surgeries over-all have a five-year success rate of only about 50%.
Therefore, there is ample published evidence that biofeedback methods of treating both urinary and fecal incontinence are very effective (and all sources agree they are totally "safe".)
Q3. What is the generally accepted standard of "Good Medical Practice" in the Treatment of Incontinence?
A3. Prior to 1988 or perhaps even 1992 one might have claimed that surgical intervention was virtually always indicated for the treatment of Urinary Stress Incontinence, and pharmacological therapy for Urge Incontinence. In October, 1988, several federal agencies combined to host a "Consensus Development Conference" on Urinary Incontinence in Adults. After hearing testimony from dozens of researchers both domestic and foreign, the distinguished panel of experts concluded that the "least invasive techniques", explicitly behavioral interventions, "should be tried first", before surgery or drugs, for many patients, since these techniques held promise of results equaling or bettering the invasive techniques without any of the risks.
During the ensuing four years there has been a proliferation specialty clinics providing biofeedback and other behavioral techniques for the treatment of incontinence. One indication of this is that the number of users of Perry™ brand sensors increased to 750 clinics. Medical device manufacturers including Self Regulation Systems, Verimed, Hollister, Synectics, and Physiodata introduced computerized systems designed especially for incontinence biofeedback work. In this same period we saw dramatic increase in national program involvement among nurses (American Urology Association Allied), physical therapists (Women's Health Section of the American Physical Therapy Association) and biofeedback technicians (Association for Applied Psychophysiology and Biofeedback), among others.
Finally, in March, 1992, a part of the U.S. Public Health Service, the Agency for Health Care Policy and Research, issued long-awaited Clinical Practice Guidelines on the Treatment of Urinary Incontinence in Adults. The Guidelines summarized the available research and concluded that behavioral techniques should be tried before drugs before surgery for the treatment of most urinary incontinence. The AHCPR Guidelines have been endorsed by all the relevant professional organizations and foundations: The American Urological Association, The American College of Obstetricians and Gynecologists, Help for Incontinent Persons, and The Simon Foundation.
Seven months later, at a national Symposium on Advances in The Management of Incontinence, Attorney Elizabeth E. Hogue argued that courts would now consider the AHCPR Guidelines as expressing the current standard of "reasonable care" that medical professionals have a legal duty to provide, or risk civil suits for negligence. She also indicated that in several recent cases insurance companies which denied patients access to contemporary standards of care by refusing to pay for them have been found guilty of "negligence" and forced to pay punitive damages. She further warned that, since surgery carries a 20% risk of complications, a patient who was not offered biofeedback therapy first and later suffered damages from surgery would have a strong case.
Q4. Who is qualified to perform EMG biofeedback of Pelvic Muscles?
A4. Because Perry™ brand sensors are classified by the FDA as Class 2 devices, they can only be used by or on the order of a "licensed medical practitioners". In most states that requires a physician's order. As is typical for medium high tech medical instruments (such as ultrasound, X-rays, urodynamics, manometrics, etc.) most biofeedback computer installations are operated by trained technicians under the direct supervision of physicians, or in many states, psychologists. Typical specialists trained in this procedure include nurses and nurse practitioners, physical and occupational therapists, biofeedback technicians, and clinical social workers.
A number of organizations have offered formal training courses and workshops in these techniques, either for their members or the general public. Among them are The Perry Institute, Self Regulation Systems, Southern Biofeedback Corporation, The Phoenix Institute, The Women's Health Section of the APTA, and the Association for Applied Psychophysiology and Biofeedback. The Biofeedback Certification Institute of America ("BCIA"), which presently certifies the competence of practitioners of general biofeedback, is currently developing plans for a specialty certification in incontinence and pelvic muscle disorders.
By 1984 the biofeedback techniques developed by the National Institute on Aging were sufficiently perfected that the NIA released a free educational videotape, "Behavioral Treatment of Urinary Incontinence: Biofeedback of the Bladder and Sphincter Muscles". The film opens with a statement by T. Franklin Williams, MD, Director of NIA, who asserts that these techniques can readily be applied by properly trained non-physicians, "especially nurses", who have been taught the principles of behavioral therapy.
Almost everyone would agree that pelvic muscle practitioners ought to be licensed (by their state) in a health-related specialty, thus ensuring that they are required by law to operate "within the scope of their training" and license.
In summary, most pelvic muscle work is quite properly done by trained non-physician specialists working under the supervision of physicians. There are three levels of protection in already in operation: (1) In most states, a physician must supply a medical diagnosis. (2) In most states, with certain reasonable exceptions, nurses and others must work only on the written order of a physician. (3) In all states, a physicians' order is required by Federal Regulations to use biofeedback instruments and devices in the treatment of a medical condition.
Q5. Isn't instruction in Kegel's Exercises a routine activity of all Registered Nurses (and, therefore, not reimbursable)?
A5. No. There are several significant differences between the verbal instruction in "pelvic floor exercise" traditionally done by nurses and the new biofeedback-controlled "Kegel Exercises" done with computerized electromyographic instruments. Most importantly, these instruments can only be used on order of an appropriately licensed medical practitioner (see previous Question).
Between 1948 and 1956 Dr. Arnold Kegel published several papers in leading journals describing the successful treatment of stress incontinence using (in every case) his manometric "Kegel Perineometer", which has been described as the world's first commercial biofeedback instrument. Unfortunately Kegel did not entrust his device to mainstream medical distribution channels, and it became more and more difficult to obtain it. Gradually nurses began perpetuating the myth that women could learn to do "Kegel's Exercises" without his perineometer, although no research ever established that that was true. In general it is agreed that "verbal" pelvic floor exercises only help those who don't really need much help; i.e., those who already have fairly strong muscles (and little or no incontinence) can make their muscles better. Paradoxically, perineal EMG biofeedback works best with patients who have moderate to severe pelvic muscle problems (and incontinence), probably because it leads to more dramatic improvements in personal and social life style.
Instrumented biofeedback therapy for incontinence is not only much more effective than pelvic floor exercise, and is much faster. The Clinician's Desk Reference: Assessment, Treatment, and Management of Incontinence states optimistically that "in mild to moderate cases, ... PFE should cure 70%+ in 3-6 months". In contrast, in clinical trials, the PerryMeter™ biofeedback system cured over 95% of stress and urge incontinence in an average of 3 to 6 weeks. Susset obtained similar results in only 6 weeks using a manometric perineal biofeedback device. Thus instrumented therapy is not only more successful, but considerably faster, than verbal instruction.