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MEDCAC Meeting

Electrostimulation for Wounds (Medical and Surgical Procedures Panel)

10/17/2000

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Issue

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.

Actions Taken

Agenda

Federal Register Notice

Agenda for October 17-18, 2000 Meeting

One West Pratt Street
Baltimore, MD 21201

Chairperson: Alan M. Garber, MD, PhD
Vice-Chairperson: Michael D. Maves, MD, MBA
Executive Secretary: Constance A. Conrad, RN

Electrostimulation for Wounds
Tuesday, October 17, 2000

8:00 – 8:30 a.m.

Registration

8:30 – 9:00 a.m.

Opening Remarks  C.Conrad
Summary of MCAC Executive Committee Recommendations  A.Garber

9:00 – 9:30 a.m.

Overview of Electrostimulation for the treatment of wounds  Rita Frantz, PhD, RN, FAAN

9:30 – 9:40 a.m.

Presentation of Questions  Perry Bridger, Lorrie Ballantine

9:40 – 9:50 a.m.

Summary of coverage history  John Whyte, MD, MPH

9:50 – 10:10 a.m.

ECRI Presentation  Jeffrey C. Lerner, PhD

10:10 – 10:20 a.m.

Wrap-up of coverage history  J.Whyte

10:20 – 10:35 a.m.

BREAK

10:35 – 12 noon

Open Public Comments & Scheduled Commentaries

Public attendees who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors.

12 noon – 1:00 p.m.

LUNCH (On Your Own)

1:00 – 1:45 p.m.

Open Public Comments & Scheduled Commentaries

1:45 – 2:15 p.m.

Open Public Comments

Public attendees who wish to address the panel will be given that opportunity.

2:15 – 2:30 p.m.

BREAK

2:30 – 3:30 p.m.

Open Committee Deliberation

Public Observers May Not Participate Except at the Specific Request of the Chairperson.

3:30 p.m.

Final Panel Recommendations

4:00 p.m.

Next Steps  Sean R. Tunis, MD, MScDirector, Coverage and Analysis Group, Office of Clinical Standards and Quality
Closing Remarks  C.Conrad

ADJOURN

Sacral Nerve Stimulation for Urinary Incontinence
Wednesday, October 18, 2000

8:00 – 8:05 a.m.

Opening Remarks  C.Conrad, A.Garber

8:05 – 8:15 a.m.

Presentation of Questions  Jennifer Doherty

8:15 – 10:00 a.m.

Open Public Comments & Scheduled Commentaries

Public attendees who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors.

10:00 – 10:15 a.m.

BREAK

10:15 – 11:00 a.m.

HCFA Presentation  Mitchell Burken, MD
BC/BS Technology Evaluation Center Assessment  Frank V. Lefevre, MD

11:00 – 12:00 noon

Open Committee Deliberation

Public Observers May Not Participate Except at the Specific Request of the Chairperson.

12 Noon – 1:00 p.m.

LUNCH (On your own)

1:00 – 1:30 p.m.

Open Public Comments

Public attendees who wish to address the panel will be given that opportunity.

1:30 – 2:15 p.m.

Open Committee Deliberation

2:15 – 2:30 p.m.

Final Panel Recommendations

2:30 p.m.

Next Steps  S. Tunis, MD, MScDirector, Coverage and Analysis Group, Office of Clinical Standards and Quality
Closing Remarks  C.Conrad

ADJOURN

Minutes

Minutes of October 17, 2000 Meeting

OPEN SESSION

Baltimore Convention center
Baltimore, Maryland

Attendees

Alan M. Garber
Chairperson

Michael D. Maves
Vice-Chairperson

Constance A. Conrad
Executive Secretary

Voting Members
Michael D. Maves
Angus M. McBryde
H. Logan Holtgrewe
Kenneth P. Brin
Les J. Zendle
Bruce Sigsbee

Consumer Representative
Phyllis E. Greenberger

Industry Representative
Marshall S. Stanton

Non-Voting Guest
Adrian Oleck

HCFA Representative
Sean R. Tunis

Tuesday, October 17, 2000, 8:30 a.m.

The Medical and Surgical Procedures Panel met on October 17, 2000, to discuss the use of electrical stimulation for the treatment of wounds. The meeting began with a reading of the conflict of interest statement, and the call to order.

Comments from Director, Coverage and Analysis Group.

Dr. Tunis welcomed panelists and participants, and explained some of the rationale for the recently released Medicare coverage memorandum on pelvic floor electrical stimulation (PFES) for urinary incontinence, and biofeedback, both topics which had been discussed by this panel in April.

Summary of MCAC Executive Committee Recommendations.

Dr. Garber informed the panel about the current status of the Executive Committee’s interim guidelines. He opined that the Executive Committee is probably going to adhere to the central questions, adequacy of evidence and size of health effect, but there may be changes in the type of evidence that may be considered.

Overview of Electrostimulation for the Treatment of Wounds.

Dr. Frantz presented an overview of the role electrical stimulation in the treatment of wounds, including how electrical stimulation works and summarizing various treatment modalities and their effectiveness.

Presentation of Questions.

A representative from the Coverage and Analysis Group of HCFA presented the questions the panel was being asked to deliberate and vote upon.

Summary of Coverage History.

Dr. John Whyte presented a summary of the coverage history of electrical stimulation for the treatment of chronic wounds.

ECRI Presentation.

Drs. Lerner and Turkelson presented the results of the technical assessment performed by ECRI.

Open Public Comments and Scheduled Commentaries.

The panelists heard from eight scheduled speakers, seven of whom were speaking as representatives of professional organizations, and one of whom was speaking as an individual clinician who used electrical stimulation for the treatment of chronic wounds.

The speakers presented results of various studies, reporting on efficacy, clinical experience and anecdotal examples, illustrating the effectiveness of electrical stimulation as an adjunct treatment for chronic wounds, including pressure ulcers, venous ulcers, and arterial or diabetic foot ulcers.

Open Public Discussion.

Following lunch, the panel heard again from scheduled speakers that had additional comments to make.

Open Committee Deliberation.

The panel discussed how the vote would be conducted and decided they would group the devices together, and the indications treated together, so they would only be voting on question concerning effectiveness, and if that passed, one question of level of health care improvement. The sense of the panel was that coverage decisions concerning specific devices or application to certain indications was a quality control issue that would be best addressed by HCFA.

Final Panel Recommendations. The panel voted on the following questions:

Is the evidence adequate to draw conclusions about the effectiveness of electrical stimulation as an adjunctive therapy for chronic nonhealing wounds (pressure ulcers, venous ulcers, arterial/neuropathic ulcers)?

The vote was unanimous in answering yes.

Is the effectiveness a breakthrough technology, more effective, as effective with advantages, as effective with no advantages, less effective with advantages, less effective with no advantages, or not effective?

A motion was made and seconded that it be considered more effective than alternative treatments. The vote was unanimous in favor of the motion.

Panel Comments on Their Votes.

The HCFA representative informed the panel that HCFA was interested in not only the votes, but also the reasons for voting as they did. Panelists made comments which are reflected in the record.

Adjournment. The meeting adjourned at 3:25 p.m.

I certify that I attended the meeting
of the Medical and Surgical Procedures Panel
on October 17, 2000, and that these minutes
accurately reflect what transpired.
_________________________________
Constance A. Conrad, R.N.
Executive Secretary, HCFA

I approve the minutes of this meeting
as recorded in this summary.
______________________________
Alan M. Garber, M.D., Ph.D.
Chairperson

Panel Voting Questions

Questions for the panel

  1. Is the evidence adequate to draw conclusions about the effectiveness of electrical stimulation as an adjunctive therapy for chronic pressure ulcers? Please consider the following points when answering this question:

    Adequacy of study design:

    Is there evidence that the studies do not over or underestimate the effect of the intervention? For example, do the patients who received the intervention differ systematically from those in the control group in ways that might affect outcomes?

    Do the studies permit conclusions about the health outcome effects of the technology?

    Consistency of results: Are the results of the studies consistent or are they contradictory?

    Applicability to the Medicare population: Are the results of the studies applicable to the various Medicare populations?

    Generalizability beyond the research setting: Are the results likely to apply in routine clinical settings?

    Expert testimony, public comments, etc. should be considered with respect to the above considerations.

  2. If the evidence is adequate to draw conclusions about the effectiveness of electrical stimulation as an adjunctive therapy for chronic pressure ulcers, what is the size, if any, of the overall health effect? Please place the size and direction of effectiveness, for each pressure ulcer stage, into one of the seven categories listed in Attachment A.

  3. Is the evidence adequate to draw conclusions about the effectiveness of electrical stimulation as an adjunctive therapy for chronic venous ulcers? Please consider the points of discussion specified in question 1 when answering this question.

  4. If the evidence is adequate to draw conclusions about the effectiveness of electrical stimulation as an adjunctive therapy for chronic venous ulcers, what is the size, if any, of the overall health effect? Please place the size and direction of effectiveness into one of the seven categories listed in Attachment A.

  5. Is the evidence adequate to draw conclusions about the effectiveness of electrical stimulation as an adjunctive therapy for chronic arterial ulcers? Please consider the points of discussion specified in question 1 when answering this question.

  6. If the evidence is adequate to draw conclusions about the effectiveness of electrical stimulation as an adjunctive therapy for chronic arterial ulcers, what is the size, if any, of the overall health effect? Please place the size and direction of effectiveness into one of the seven categories listed in Attachment A.
Attachment A: Categories of Effectiveness

Breakthrough technology: The improvement in health outcomes is so large that the intervention becomes standard of care.

More effective: The new intervention improves health outcomes by a significant, albeit small, margin as compared with established services or medical items.

As effective but with advantages: The intervention has the same effect on health outcomes as established services or medical items but has some advantages (convenience, rapidity of effect, fewer side effects, other advantages) that some patients will prefer.

As effective and with no advantages: The intervention has the same effect on health outcomes as established alternatives but with no advantages.

Less effective but with advantages: Although the intervention is less effective than established alternatives (but more effective than doing nothing), it has some advantages (such as convenience, tolerability).

Less effective and with no advantages: The intervention is less effective than established alternatives (but more effective than doing nothing) and has no significant advantages.

Not effective: The intervention has no effect or has deleterious effects on health outcomes when compared with "doing nothing," (e.g., treatment with placebo or patient management without the use of a diagnostic test).

Contact Information

Other Material

Memo to Panel

To:                   Members and Guest of the Medical and Surgical Procedures Panel of the Medicare Coverage Advisory Committee

From:               John J. Whyte, MD, MPH
                        Medical Officer, Coverage and Analysis Group

                        Lorrie Ballantine
                        Perry Bridger, MHS
                        Health Insurance Specialists, Coverage and Analysis Group

Subject:           Background Information on Electrical Stimulation for Wounds

Date:                September 25, 2000

The purpose of this memo is to provide a general background on the history of the Medicare coverage process relating to electrical stimulation for the treatment of chronic wounds. A timeline of activities may be helpful in understanding how the issue has developed over the years, and why it is referred to your committee. The documents referenced have been included in this mailing. More detailed information will be provided at the upcoming panel meeting, including a general discussion at the beginning of the meeting explaining the physiology of electrical stimulation.

A. Timeline of Activities

  • 1970’s – Medicare carriers reimbursed for some forms of electrical stimulation for wound healing on a case-by-case basis. No national coverage policy was in place.
  • 1981 – HCFA issued a national non-coverage policy for low intensity direct current in the treatment of pressure ulcers.
  • 1994 – The Agency for Health Care Policy and Research (AHCPR) convened an independent panel of experts, who produced a clinical practice guideline entitled Guidelines on Treatment of Pressure Ulcers. In a section on adjunctive therapies, the guidelines advised physicians to "consider a course of treatment with electrotherapy for Stage III and IV pressure ulcers that have proven unresponsive to conventional therapy… Electrical stimulation may also be useful for recalcitrant Stage II ulcers." The guideline states that the recommendation was based on data from five clinical trials, involving a total of 147 patients. AHCPR assigned this portion of the guideline a strength of evidence level of B. AHCPR defines strength of evidence as level B if there is fair research-based evidence to support the guideline.
  • 1995 – In an effort to gain greater clarity on this topic, HCFA ordered a technology assessment of electrical stimulation. ECRI, a technology assessment firm in Plymouth Meeting, PA was awarded the contract.
  • 1996- ECRI completed the report, and HCFA referred the topic to its Technology Advisory Committee (TAC). The TAC consisted of government physicians, and HCFA Contractor Medical Directors. The TAC reviewed the ECRI report and noted that wound healing outcomes in many of the ECRI studies were compromised by several "confounding factors". The TAC voted to issue a noncoverage recommendation. (See Section B: Brief Summary of ECRI Report).
  • ECRI updated its original report. Based on the TAC’s recommendation, HCFA rescinded carrier discretion and issued a broad national noncoverage policy.
  • The American Physical Therapy Association (APTA) filed suit in federal district court in Massachusetts (Aitken v Shalala) to challenge the national noncoverage determination.
  • The court issued a preliminary injunction preventing HCFA from issuing the national noncoverage policy, and instead remanded the issue back to the agency to either provide a more detailed explanation of the noncoverage determination, or a revision of that determination.
  • Subsequent to the court’s decision, HCFA requested ECRI to perform an analysis of the basis of HCFA’s decision in response to the court’s action. In a January 23, 1998 letter to the agency, ECRI primarily addressed two issues. The first issue focused on some imprecise wording of "minimal" and "no therapy". The second issue centered on the statement that there were no comparative studies of electrical stimulation versus conventional therapy.
  • HCFA also sought AHCPR’s comment of the ECRI response to the Aitken v. Shalala outcome. On October 14, 1998 HCFA received a memorandum from AHCPR’s Center for Practice and Technology Assessment. This memo opined that the overall conclusions (of the initial ECRI report) "remain valid." Regarding the Guidelines on Treatment of Pressure Ulcers, the letter notes: "the guidelines simply state that electrical stimulation could be considered as treatment for certain pressure ulcers unresponsive to conventional therapy."
  • 1999 - HCFA also provided APTA an opportunity to comment on AHCPR’s and ECRI’s letters. Their thoughts are summarized in an April 1, 1999 letter.
  • 1999 - Because of the continued controversy on the strength of the evidence, HCFA decided that the issue would go to the Medicare Coverage Advisory Committee.

B. Brief Summary of the ECRI Report

ECRI’s Quantitative Conclusions were as follows:1

  1. Electrical stimulation facilitates the healing rate of chronic ulcers.

  2. Electrical stimulation facilitates the complete healing of chronic ulcers.

  3. The relationship between outcomes and electrical stimulation can be affected by wound size and type of stimulator

  4. Decubitus ulcers are more likely to heal completely in response to electrical stimulation than venous ulcers.

The Qualitative Conclusions were as follows:2

  1. Although all electrical stimulation studies have at least 1 weakness, not all are potentially confounded.

  2. Electrical stimulation controlled studies for venous ulcers are about equal to or slightly inferior in quality compared to other controlled studies for venous ulcers

  3. Electrical stimulation controlled studies for decubitus ulcers are about equal to or slightly superior in quality compared to other controlled studies for decubitus ulcers.

The General Findings were as follows:3

  1. Electrical stimulation devices are safe when used appropriately.

  2. Most types of electrical stimulation are more effective than minimal treatment.

  3. Electrical stimulation is not markedly superior to or inferior to conventional or alternative therapies. There is insufficient evidence to determine if clinically significant differences exist.

Following the Quantitative Conclusions, ECRI provided greater detail regarding specific types of wounds, and specific types of current. Statements are summarized in the following table:

Summary of ECRI’s Quantitative Conclusions regarding evidence of effectiveness for specific modalities of electrical stimulation for specific types of wounds.4

  Decubitus Ulcers Venous Ulcers Diabetic Ulcers
Direct Current No Evidence of Improved Healing Rate Not specifically addressed No Evidence of Improved Healing Rate
Pulsed Direct Current Evidence of improved healing rate for Stage II through IV ulcers No Evidence of Improved Healing Rate No Evidence of Improved Healing Rate
Alternating Current Evidence of improved healing rate No Evidence of Improved Healing Rate No Evidence of Improved Healing Rate
Transcutaneous Electrical Nerve Stimulation Not specifically addressed No Evidence of Improved Healing Rate No Evidence of Improved Healing Rate
Pulsed Electromagnetic Field No Evidence of Improved Healing Rate Evidence of improved healing rate. Improvement appears small and may not be clinically useful No Evidence of Improved Healing Rate
Pulsed Electrical Energy Evidence of improved healing rate for stage II ulcers. Insufficient data to determine if PEE improves healing rate for stage III and IV ulcers. No Evidence of Improved Healing Rate No Evidence of Improved Healing Rate

C. Analysis of Recently Published Data

In order to supplement the ECRI technology assessment, HCFA staff completed several independent searches of the medical literature to identify relevant research published since the ECRI report. HCFA staff set broad search parameters in order to find as much relevant evidence as possible regarding the appropriateness and effectiveness of electrical stimulation. These searches yielded clinical trials, case series, meta-analysis, literature reviews, and opinions. This review also included unpublished articles recommended by APTA. All of these articles were abstracted using the same instrument that HCFA uses for all systematic literature reviews. These articles are included in this mailing, and the abstraction can be found in Appendix A, "Articles Published Since the ECRI Report".

Should you have any additional questions or need more information, please do not hesitate to contact Dr. John Whyte at (410) 786-9668, Perry Bridger, at (410) 786-1948, or Lorrie Ballantine at (410) 786-7543. We look forward to seeing you on October 17.

1 These may be found on pg 2 of the Executive Summary.

2 These may be found on pg 2 of the Executive Summary.

3 These may be found on pg 4 of the Executive Summary.

4 Information obtained from pages 2-4 of Executive Summary.

Associated NCA

Associated Technology Assessment

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