Electrostimulation for Wounds & Sacral Nerve Stimulation for Urge Urinary Incontinence (Executive Committee)

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=9 | meeting_date=2001-02-22

Electrostimulation for Wounds Electrostimulation (E-stim) applied to chronic venous, arterial and pressure ulcers to accelerate healing, has been utilized as a possible therapeutic modality for several decades. Several types of E-stim for the treatment of chronic ulcers currently are in use, and the effectiveness of electrical therapy for different categories and severity of chronic ulcers remains controversial. In April 1997, the Centers for Medicare & Medicaid Services (CMS) issued a national noncoverage policy (Coverage Issues Manual (CIM) section 35-98) for E-stim for the treatment of wounds. Pursuant to a court order, CMS issued a program memorandum (PM) to its contractors in December 1997, precluding them from giving any effect to the April 1997, national noncoverage determination published in the CIM. This instruction was recently renewed in PM AB-00-53. Therefore, coverage for E-stim for the treatment of wounds remains at carrier discretion. Sacral Nerve Stimulation for Urge Urinary Incontinence Sacral nerve stimulation, or sacral nerve neuromodulation, is defined as the implantation of a permanent device that modulates the neural pathways controlling bladder function by delivering controlled electrical impulses to the sacral nerves. Currently, no national coverage decision is in place; and, therefore, coverage of this item and service is determined at the carrier level. HCFA will evaluate whether the current literature supports a national coverage policy for the use of sacral nerve stimulators.

Agenda: Federal Register Notice Associated Nca: Electrostimulation for Wounds (CAG-00068N) Sacral Nerve Stimulation for Urge Urinary Incontinence (CAG-00058N) Issue: Electrostimulation for Wounds Electrostimulation (E-stim) applied to chronic venous, arterial and pressure ulcers to accelerate healing, has been utilized as a possible therapeutic modality for several decades. Several types of E-stim for the treatment of chronic ulcers currently are in use, and the effectiveness of electrical therapy for different categories and severity of chronic ulcers remains controversial. In April 1997, the Centers for Medicare & Medicaid Services (CMS) issued a national noncoverage policy (Coverage Issues Manual (CIM) section 35-98) for E-stim for the treatment of wounds. Pursuant to a court order, CMS issued a program memorandum (PM) to its contractors in December 1997, precluding them from giving any effect to the April 1997, national noncoverage determination published in the CIM. This instruction was recently renewed in PM AB-00-53. Therefore, coverage for E-stim for the treatment of wounds remains at carrier discretion. Sacral Nerve Stimulation for Urge Urinary Incontinence Sacral nerve stimulation, or sacral nerve neuromodulation, is defined as the implantation of a permanent device that modulates the neural pathways controlling bladder function by delivering controlled electrical impulses to the sacral nerves. Currently, no national coverage decision is in place; and, therefore, coverage of this item and service is determined at the carrier level. HCFA will evaluate whether the current literature supports a national coverage policy for the use of sacral nerve stimulators. Minutes: Minutes of February 22, 2001 Meeting Baltimore Convention Center One West Pratt Street Baltimore, Maryland Attendees Harold C. Sox, M.D. Chairperson Robert H. Brook, Ph.D. Member at Large Constance Conrad Executive Secretary Voting Members Thomas V. Holohan, M.D.,F.A.C.P. Leslie P. Francis, J.D.,Ph.D. John H. Ferguson, M.D. Robert L. Murray, Ph..D. Alan M. Garber, M.D., Ph.D. Michael D. Maves, M.D., M.B.A. Frank J. Papatheofanis, M.D., Ph.D. Daisy Alford-Smith, Ph.D. Joe W. Johnson, D.C. Barbara J. McNeil, M.D.,Ph.D. HCFA Liaison Sean R. Tunis, M.D.,M.Sc. Consumer Representative Linda A. Bergthold, Ph.D. Industry Representative Randel E. Richner, M.P.H. Thursday, February 22, 2001, 8:35 a.m. The Executive Committee of the Medicare Coverage Advisory Committee met on February 22, 2001, to review and approve the recommendations of the Medical and Surgical Procedures panel coming from its October 17 and 18, 2000 meeting, to discuss comments received concerning the MCAC interim guidelines, and the future role of the MCAC Executive Committee following enactment of BIPA. The meeting began with the introduction of the Committee, a reading of the conflict of interest statement, and the call to order. Review and Approval of Medical and Surgical Procedures Panel Recommendations. Following presentation of the recommendations of the Medical and Surgical Procedures Panel’s recommendations concerning electrostimulation for the treatment of wounds, and sacral nerve stimulation for the treatment of urinary incontinence, the Executive Committee held a discussion. Several committee members asked HCFA to send the committee a more thorough summary of panel deliberations and discussion the next time that the Executive Committee meets to review a panel's recommendations. Following the discussion, the Executive Committee voted as follows: The Executive Committee voted unanimously to ratify the recommendations to HCFA about the evidence on using electrostimulation to treat wounds. Dr. Ferguson abstained from the vote pertaining to sacral nerve stimulation for the treatment of urinary incontinence. The remaining Executive Committee voting members voted unanimously to ratify the recommendations. Discussion of Interim Guidelines that provide guidance to MCAC specialty panels . The chairperson gave a brief history of the guidelines provided by the Methods Subcommittee. Following comments from each committee member indicating overall satisfaction with the proposed guidelines, the chairperson invited Ms. Richner to share a Power Point presentation she had created outlining the proposed guidelines. The panel used this diagram to guide their discussions. During the discussion, the committee took two straw votes approving changes to the guidelines, with the entire panel voting. The Executive Committee voted unanimously to approve the following statement: At the time that HCFA places the Evidence Report on its website, it must make available to the public any information that the contractor used in writing the Evidence Report. If an author does not grant permission to release the information at this time, the contractor may not use the information in the Evidence Report. The Executive Committee voted to insert the following statement on the purpose of the MCAC advisory panels: This process is intended to serve the public by identifying medical goods and services that improve the health of Medicare beneficiaries. The straw vote taken on this change was all in favor with one exception, that being a "no" vote. Public Comments. Two members of the public, both industry representatives, made comments to the committee. They were generally in favor of the expanded public participation in the MCAC process. They urged the committee to follow stringent, predictable schedule during the review process. They also urged the committee to consider a broad range of types of evidence. Final Committee Opinions. All members of the Executive Committee voted unanimously to adopt the following statement: The overall content of the interim guidelines is sound. The chairperson may correct any typographical errors and do minor word-smithing. The Executive Committee must approve any other changes, except those approved by the straw votes in today’s session. The document is an interim operations guideline and subject to continuing change. Executive Committee members who desire changes should submit them to the chair for placement on agenda at the next Executive Committee meeting. Discussion on Role of Executive Committee in the Future. Because of inclement weather, the chairperson announced that he would merely ask Dr. Tunis to give the Executive Committee a brief overview of the recently passed Benefits Improvement and Protection Act (BIPA), and asked the panelists to consider possible roles of the Executive Committee following enactment of the Act. Dr. Tunis went through the Act briefly. Following that, there was a brief discussion of the Executive Committee’s future role, focused on what the committee’s review role will be, since formal ratification of specialty panel recommendations may no longer be required. The EC may be asked to assist in the development of questions for panel issues. HCFA Announcements/Information. Dr. Tunis stated that the next meeting of the Executive Committee had not been scheduled, but it would likely take place either in late spring or early summer. Adjournment. The meeting adjourned at 12:05 p.m. I certify that I attended the meeting of the Executive Committee on February 22, 2001, and that these minutes accurately reflect what transpired. _________________________________ Constance Conrad Executive Secretary, HCFA I approve the minutes of this meeting as recorded in this summary. ______________________________ Harold C. Sox, M.D. Chairperson Other Material: Transcript 1