Medicare’s Brave New World
Of Incontinence Treatment

Kegel’s Perineometer Will Not Be Reimbursed,

But Failure at Kegel Exercises is Now Required.

 

 

By John D. Perry, PhD

Chair, AAPB Task Force on Incontinence[1]

 

 

Effective July 1, 2001, The Health Care Financing Administration has created a Brave New World of Incontinence Treatment Regulations. 

 

The new rules, which were intended to enshrine only rock-solid evidence-based-medicine, have resulted in the creation and institutionalization of a hybrid therapeutic system that seems designed to serve the needs of major instrument manufacturers and professional guilds, rather than Medicare’s patient population. 

 

Heading the list of irregularities is the fact that none of the public testimony during April or June 2000 even mentioned the new system, and it has not only not been proven, it has never been the object of even a single empirical study.  Such is the fate of “evidence-based-medicine” – which has subsequently been abandoned by HCFA anyway. (Note 1) 

 

The new regulatory morass came in two easy steps.  On April 1, 2001 (not a joke), HCFA changed the status of external "electrical stimulation" from "absolutely NOT covered" to "nationally covered" under certain minimal restrictions.  Electrical stimulation systems utilize portable device for daily at-home "therapy"; there is no such thing as a "clinical" stim unit (although some clinical EMG units contain relays to trigger external stim devices.)

 

 

PME FAILURE NOW REQURIED

 

Two restrictions -- one partly expected, the other totally out of the blue -- were announced.  The first: as anticipated, coverage for electrical stimulation will be allowed only after failure at verbal-instruction-only pelvic muscle exercise (PME), commonly (but incorrectly) known as "Kegel Exercises". 

 

But in a strange twist, HCFA has suddenly demanded an "ordered" program of four weeks effort to control urinary leakage.  It is not stated whether the four weeks must be “prospective” or can be “retrospective”.  Regional rules may clarify this – or further confuse the issue.

 

The "Four Weeks Failure" clause was not anticipated and its source remains an enigma.  While it is a tradition for federal regulations to insist that a patient "fail" some sort of "conventional" treatment, it doesn’t make much sense to require a test that virtually every patient will fail.  Even organizations, such as the National Association for Continence, that actively promote PMEs admit it takes 4 to 6 months to achieve significant results.  No one is going to get significant improvement in 4 weeks.  So what is the purpose of the rule?  We aren’t told.  [Note that there is no corresponding four-week-waiting period for drugs or surgery.]

 

And as Diane Smith said in response, “I’ve never met a patient who hasn’t failed PME alone!” (Obvious, if they had succeeded, they wouldn’t be coming to her clinic.) 

 

 

INSERTED ELECTRODES REQUIRED

 

The second restriction is that "stim" is only reimbursable when patients use an inserted vaginal or anal electrode – not when using surface patch electrodes!  This restriction might otherwise be a welcome event, since this author invented and endorses an inserted vaginal/anal electrode that can be used for both EMG and stim, and personally stands to reap substantial financial rewards under the new regulation.  But our personal joy is tempered by professional concern and skepticism. 

 

Finally on July 1, 2001 – more than 14 months after the public hearings -- Medicare began offering reimbursement for biofeedback used in treating urinary incontinence.  The new regulations include the same infamous “Four Week Failure” clause (with no more clarity than under the stim rules). 

 

And there were two new surprises.  First, unlike stim, inserted vaginal or anal sensors are NOT required for biofeedback.  This is the reverse of clinical experience, which shows that inserted sensors provide more accurate signals for EMG, but stimulation works just as well with patch electrodes as it does with inserted ones.  This is because fatty peritoneal tissue attenuates EMG signals, but a stim device can be “turned up” to compensate.

 

 

KEGEL LEFT OUT OF PLAN

 

The second surprise was the exclusion of home biofeedback trainers from coverage.  The regulators chose to follow the Kathy Burgio “office-only” biofeedback model.  Burgio’s NIH clinic had used a full sized polygraph, for which (at the time of the hearings) there is no readily available home trainer.

 

Ironically, Arnold Kegel's original 1948 perineometer, the device which started this whole revolution a half century ago, and which was designed for daily home practice, will not be covered under the new Medicare plan, which does not pay for any biofeedback device used in the home. 

 

The exclusion of home biofeedback is especially bothersome because it is the use of daily home training that has produced the best clinical outcomes, according to both government[2] and private research[3].  

 

Worse yet, not only are at-home biofeedback instruments not covered, but physicians (and nurses, physical therapists, and biofeedback specialists) will not be allowed to charge for visiting invalid patients at home. 

 

This is not only unjust treatment of Medicare’s most serious patients, but also ironic, since in the past decade manufacturers have worked hard to perfect miniature portable "labs" based on laptop computers to provide all the power of office-level technology on the road.  HCFA drew no distinction between $400 home practice devices and $12,000 portable computerized systems – neither will be reimbursed when used in the home.  [But ironically, a $400 home trainer can be used as it were a $12,000 office system, and will be reimbursed at the same rate!]

 

This rule is especially insulting to famous nurses Diane Smith and Diane Newman, who pioneered the treatment of homebound seniors in a New Jersey state research project in the late 1980s under a grant from the Robert Wood Johnson foundation[4].  According to the new regulations, all incontinence biofeedback must be done in an office, hospital or similar "facility".  (Strangely, there were no such restrictions placed on stim.)

 

The net effect of these two sets of rules is that biofeedback is “OK” in the office, and electrical stimulation is “OK” at home and in the office.  This has created a new model of clinical practice that has never been the subject of formal research by experimenters.  Yet it is destined, for the time being, to become the new national standard of practice.  

 

The new plan is similar to the “New York Blue Cross” plan; last year that group began to cover biofeedback at clinical visits, but only when electrical stimulation units were also prescribed for daily home practice.  There has never been any research based on the NYBC treatment plan, but that won’t stop it from become the new national norm. 

 

 

ONE ASSUMPTION REQUIRED

 

For the NYBC plan to become national practice requires only one very believable assumption -- that practitioners will, as they always have -- bill Medicare for as many HCPCS codes and modalities as they possibly can get away with in a single office visit.  Thus the most lucrative clinical pattern will be to provide and charge the patient for BOTH office biofeedback AND electrical stimulation in a single visit.  The patient will then take the stim unit home for daily treatment – rental or purchase paid for by Medicare. 

 

Ironically, the requirement for inserted stim sensors means that sensors will also be available for EMG biofeedback, providing better results than surface electrodes.  Although it is possible to do stim without objective measurements, the additional reimbursement for biofeedback in the clinic will prompt clinicians to actually evaluate pelvic muscle condition on a weekly basis – something that should be done anyway.  In the past the extra cost of inserted sensors was a barrier to biofeedback, but now it is a requirement for reimbursement. 

 

 

THE FUTURE OF BIOFEEDBACK

 

It is rumored that the new regulations will come up for review in three years, which should be sufficient time for biofeedback clinicians to collect comparative data about relative efficacy of biofeedback versus stim home devices.  Hopefully the increased coverage will create a larger pool of data from multiple sites. 

 

As a matter of clinical expediency, biofeedback therapists should point out to their Medicare patients who can afford it that they can rent an EMG home trainer for less than the cost of their present (non-reimbursed) adult incontinence products.  Those who can afford it will do so, and the rest will continue to get inferior medical care under Medicare. 

 

 

 

Note 1.  In April 2000 an elaborate framework of scientific panels reviewing “evidence-based-medicine” (EBM) research by outside assessment organizations was created and used to review biofeedback and (external) electrical stimulation in the treatment of urinary incontinence.  But HCFA received substantial criticism on the new procedure, and a few weeks later it was abandoned when “implanted electrical stimulators” were reviewed with no pretense of “EBM”.  The Medtronic “InterStim” device was quickly and quietly approved on the basis of a single research study prepared and funded by the manufacturer.