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The Latest on Medicare

July 1, 2001: HCFA announces new Biofeedback for incontinence regulations; Strangely, Kegel’s Perineometer Will Not Be Reimbursed, But Failure at Kegel Exercises is Now Required. Read more!

April 2, 2001: HCFA has just announced that the new Regulations, which were to go into effect on April 1, 2001, will now be DELAYED until July 1, 2001, because of "a reply" received during the "comment period".

October 6, 2000: HCFA released its long-awaited coverage policy decision on Biofeedback for Incontinence -- Coverage, which was previously optional at the regional carrier level, is now REQUIRED nationally! For the full text of the coverage decision, visit http://www.hcfa.gov/coverage/8b3-x4.htm.

October 6, 2000: HCFA also announced required national coverage for Electrical Stimulation for Incontinence, but only as a secondary procedure; the full text is located at http://www.hcfa.gov/coverage/8b3-w4.htm.

August 1, 2000: HCFA announced that a coverage decision will be made public by September 21st. In the meantime, a coalition of professional organizations led by AUGS has scheduled a private meeting with HCFA administrator Nancy-Ann Min DeParle for a last-minute appeal on August 21st. Currently the delegation consists of: Diane Newman, RN, Nicolette Horbach, MD, Jerry Connolly, PT, Kathryn Burgio, PhD, Barbara Woolner, RN, Alfred Bent, MD, and Jodi Chappell.

July 11, 2000: HCFA's interim rules for technology assessments call for an "external review" by "independent experts" prior to public hearings -- but that wasn't done for the "Incontinence" hearings due to poor timing. So a group of Biofeedback Experts has prepared an "External Review of the TEC Biofeedback Evaluation" which was sent to HCFA today. The biofeedback experts are highly critical of the BlueCross/BlueShield evaluation.

July 6, 2000: EMPI, a leading manufacturer of electrical stimulation products, has sent a detailed critique of HCFA's handling of stim research to Sean Tunis, MD, the new head of the Coverage and Analysis Group. The text is from EMPI.

June 25, 2000: The first NEWSPAPER coverage of the Medicare Incontinence battle appeared today in the St. Paul (MN) PioneerPlanet. The story features the local EMPI, Inc. and EMPI's perspective on Medicare reimbursement, as well as other industry representatives. At our request, the newspaper has moved this story to a "non-expiring" folder with a new link (above).

June 6, 2000: Medicare Executive Committee ratified the Medical-Surgical Panel's negative report on biofeedback and electrical stimulation in the treatment of incontinence. Click here for the Transcript which is posted on HCFA's website. PowerPoint Testimony on both "HCFA process" and "Med-Surg ratification" by Kevin Connolly, CEO of SRS Medical Systems, Inc., is posted as well.

Protests against HCFA hearing procedures continue.

June 1, 2000: Three new protest letters have been sent to HCFA/MCAC in reaction to the April 12-13 Incontinence hearings. The American Medical Association has suggested that clinical evidence as well as "scientific" evidence should be considered. A group of Nine Professional Organizations has also criticized the "narrow scope questions posed to panelists". And the largest manufacturer of electrical stimulation and biofeedback instruments, EMPI, Inc., has recommended eight specific changes in the procedures. Click on the links above to see their letters.

In the aftermath of the unbelievable 9-2 vote against biofeedback, panelists and presenters have started to lodge official protests with HCFA's Executive Committee. The first is the complaint of the Consumer Representative, Phyllis Greenberger, MSW. Then the Continence Coalition protested. Now the AAPB's Committee on HCFA has presented a very comprehensive catalog of problems in the HCFA procedure and BC/BS TEC report which they endorsed. The protest of Diane Smith, who was a special guest member of the panel (without vote) has now been added. Additional protest documents will be posted as received. (To be automatically alerted to the latest developments, click on "JOIN our E-Mail List" above.) APTA has reportedly filed a protest which will be posted to their website.

Official Transcripts of the April 12-13 HCFA hearings on (1) Biofeedback and (2) Electrical Stimulation for the treatment of Urinary Incontinence have been posted at: Biofeedback Hearings and Electrical Stimulation hearings. Note that the most interesting part is the first hour of the stim hearings, when panel members complained about the procedure which forced them to vote "against" biofeedback, based on the prejudicial format of the agenda. Panel members were not allowed to recommend for or against actual reimbursement by Medicare. Several "no" voters stated that they would have voted in favor of biofeedback coverage if allowed to do so. See how your tax dollars are being spent!

HCFA's Medicare Coverage Advisory Committee met April 12-13, 2000 in Baltimore to discuss national reimbursement policy for Biofeedback and Electrical Stimulation treatments of Incontinence. In a controversial proceeding, the "Med-Surg" panel voted 7-2 and 7-1-1 respectively that there is NO "SCIENTIFIC" EVIDENCE in support of Biofeedback or Electrical Stimulation as treatments for incontinence. In the case of biofeedback, all of the male physicians voted against biofeedback, while both female physicians voted in favor of biofeedback. Does that tell you anything? IncontiNet has offered to publish the disregarded testimony of all professional organizations and individuals at the hearing. So far the following have responded to our offer:

Association for Applied Psychophysiology and Biofeedback (aapbbio.ppt) and (aapbstim.ppt), presented by John D. Perry, PhD. [PowerPoint presentations; visit microsoft.com for a free viewer if you need it.]

American College of Obstetricians and Gynecologists (acogbio.doc) and (acogpfes.doc), presented by Alfred Bent, MD;

American Physical Therapy Association (aptabio.doc), presented by Cyndy Feldt, PT, and (aptastim.doc), presented by Julie Pauls, PT, PhD;

Agency for Health Care Policy and Research (ahcprbio.doc), presented by Diane Newman, RN, MSN (and Andy Fantl, MD).

What Went Wrong? For an open letter sent to all presenters after the hearing, see "Monday Morning Quaterbacking" for a preliminary discussion of "What Went Wrong at HCFA?".

Background: Dr. John Whyte had asked professional organizations to discuss their positions with each other before the meeting. For the available documents, click here. For additional information, visit the SUNA and WOCN websites. Official Information is also available on the HCFA website.

Conceptual and Factual Errors in the BC/BS TEC REPORTS
Several new papers that detail errors in the TEC reports have been collected from the incontinence@eGroups email list and posted here. The compilation "April12.htm" includes
(1) Berghmans' Conceptual Confusion (the claim that biofeedback is a form of physical therapy),
(2) What the EC recommended to Panels (procedures violated by HCFA),
(3) Dr. Landy's "report" (an expert's critique of the TEC report),
(4) Dr. Zendle's "report" to the panel,
(5) "The slide they asked to see" (contents of Dr. Perry's slide, not included in the transcript, ranking the effects of adding components to 'PMEs Alone';
(6) Another BC/BS error (Burgio and Burton) (which points out Burton's PME Alone group did NOT get PME alone at all);
(7) What happened to the AHCPR Guidelines (which were not distributed to the Med-Surg Panel;
(8) No Relevant Outcomes? (comments on BC/BS-TEC's handling of the Castledon and Taylor & Henderson reports),
(9) TEC's three forms of bias (critical comments on the claims of Selection, Attribution, and Performance Bias in the TEC report. Also points out that Franke et al did NOT have a PME alone group and, like Burton et al, should have been excluded by TEC); and
(10) Three additional forms of bias (a discussion of Trainer, Protocol, and Instrumentation Bias, which are potential errors in analyzing behavioral medicine research in an evidence-based-medicine study.

Commentaries on Recent Incontinence Research

being considered by the Medical-Surgical Panel have been posted by John Perry to some email lists, and they are collected here for easy reference. They include:

      1.     Berghmans et al Abstract on Urge Incontinence (February 2000)
2.     Commentary on Berghmans et al on Urge Incontinence
3.     Comments on Electrical Stimulation for Stress Incontinence (Sand 1995, Brubaker 1997)
4.     Comments on SANS (leg nerve) stimulation for Incontinence.
5.     Katherine Moore on E-stim for Men (JWOCN) Jan. 2000
6.     Minimalist Therapy for Elderly Incontinence (Weinberger, Goodman, and Carnes, 1999)

And From 1998:

The Backlash against Biofeedback is reaching epidemic proportions! Check out our review of the AEtna/Medicare policy statement on biofeedback. In Florida, Medicare is trying to cut reimbursement for biofeedback to 1/2 its current level. And nationally, Blue Cross/Blue Shield's Technology Evaluation Center has prepared an extremely biased report which says biofeedback is worthless! Seriously, we must be threatening someone!

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