National Coverage Analysis (NCA) Tracking Sheet

Electrostimulation for Wounds

CAG-00068N

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.

Benefit Category

Incident to a physician's professional Service
Outpatient Physical Therapy Services
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
CMS internally generated request N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
08/28/2000
Expected NCA Completion Date
07/23/2002
Public Comment Period
09/27/2000 - 10/27/2000
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
07/23/2002

Contacts

Lead Analysts
Lorrie Ballantine
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

August 28, 2000

Scheduled for the October 17-18, 2000, MCAC Medical and Surgical Procedures Panel

Referred to the HCFA Center for Health Plans and Providers (CHPP) for final benefit category determination

September 25, 2000

Items posted today:
  • Technology Assessment by ECRI on Electrical Stimulation for the Treatment of Chronic Wounds - April,1996
  • Update to TA prepared by ECRI [PDF, 1MB] - March, 1997
  • Bibliography of all articles reviewed
  • Literature Review prepared by HCFA staff on articles/studies since the ECRI report [PDF, 235KB]
  • Various letters
  • January 23, 1998 - Letter from ECRI concerning Aiken v. Shalala [PDF, 404KB]
  • October 14, 1998 - Letter from Agency for Health Care Policy and Research (AHCPR) [PDF, 403KB]
  • April 1, 1999 - Letter from the American Physical Therapy Association (APTA) concerning the ECRI and AHCPR letter [PDF, 1MB]
  • Questions to be answered at the panel meeting
  • AHCPR guidelines on Treatment of Pressure Ulcers can be obtained through their website at: www.ahrq.gov/clinic/cpgonline.htm.
  • Background Memo on this issue.
  • On September 8th, 2000 we announced in the Federal Register our plans to hold a public meeting of the Medicare Advisory Committee to review Electrical Stimulation for the the Treatment of Chronic Wounds. A deadline for presentation and comments were due by September 26, 2000. By this posting we are extending that deadline to Friday, October 6, 2000.

    February 21, 2001

    Executive Committee of the Medicare Coverage Advisory Committee  ratified the decision of the October Medical and Surgical Procedures Panel.

    May 1, 2001

    Received Signed Minutes from the February Executive Committee MCAC Meeting. Decision due within 60 days.

    August 27, 2001

    Given additional information received on the definition of "chronic" wounds, and whether all wounds heal the same, we will extend the deadline to September 30, 2001. The MCAC concluded there was adequate evidence regarding e-stim for pressure ulcers, but little literature existed on other types of wounds. They believed that it might be reasonable to extrapolate across different wound types, but did not conclude that the wound healing process was the same for all types of wounds. Additional time is needed to further explore the issue regarding whether it is reasonable to extrapolate findings from one type of wound to other wounds.

    September 27, 2001

    The due date for this request has been extended to October 27, 2001, to allow for additional review.

    October 18 , 2001

    The due date for this request has been extended to allow for additional review. We received a new letter, which included additional information from the American Physical Therapy Association (APTA).

    We have also received a Technology Assessment, Systematic reviews of wound care management: (5) beds; (6) compression; (7) laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy from the National Coordinating Centre for Health Technology Assessment, Southampton, UK.

    January 14, 2002

    In light of the court order in the matter of "Aitken v. Shalala", 986 F. Supp 57 (D.Mass., 1997), we are preparing a decision memorandum, but will not post the document until we have supplemented the record and the court has issued its opinion.

    July 23, 2002

    CMS posts decision memorandum announcing our intent to issue a limited positive national coverage determination.