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Notice

Medicare Program; Withdrawal of Medicare Coverage of Multiple-Seizure Electroconvulsive Therapy, Electrodiagnostic Sensory Nerve Conduction Threshold Testing, and Noncontact Normothermic Wound Therapy

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Information about this document as published in the Federal Register.

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AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Notice.

SUMMARY:

This notice announces our decisions previously set forth in program instructions to withdraw Medicare coverage for multiple-seizure electroconvulsive therapy (sometimes referred to as multiple electroconvulsive therapy), electrodiagnostic sensory nerve conduction threshold testing, and noncontact normothermic wound therapy.

DATES:

This notice provides Federal Register confirmation of the coverage withdrawals previously published as program instructions effective April 1, 2003, for multiple-seizure electroconvulsive therapy, October 1, 2002, for electrodiagnostic sensory nerve conduction threshold testing, and July 1, 2002, for noncontact normothermic wound therapy.

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FOR FURTHER INFORMATION CONTACT:

Anthony Norris (410-786-8022) for multiple-seizure electroconvulsive therapy. Lorrie Ballantine (410-786-7543) for electrodiagnostic sensory nerve conduction threshold testing and noncontact normothermic wound therapy.

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SUPPLEMENTARY INFORMATION:

On April 27, 1999, we published a notice in the Federal Register (64 FR 22619) that established the procedures used for making national coverage determinations (NCDs). The April 27, 1999 notice also described the procedures we used to implement NCDs. In the notice we stated that if we chose to “withdraw or reduce coverage Start Printed Page 44089for a service,” we would publish the decision as a general notice in the Federal Register (64 FR 22624).

Multiple-seizure electroconvulsive therapy (MECT), sensory nerve conduction threshold testing (sNCT), and noncontact normothermic wound therapy (NNWT) did not have NCDs governing Medicare coverage prior to the effective dates noted above. Therefore, coverage for each of these services was at the discretion of the local Medicare contractor.

This notices restates our previous decisions, announced in program instructions, to withdraw coverage nationally for multiple-seizure electroconvulsive therapy (CR 2499, TR AB-03-003, 01/10/03), electrodiagnostic sensory nerve conduction threshold testing (CR 2153, TR AB-02-066, 05/02/02), and noncontact normothermic wound therapy (CR 2027, TR AB-02-025, 02/15/02). Medicare has not covered multiple-seizure electroconvulsive therapy, electrodiagnostic sensory nerve conduction threshold testing, and noncontact normothermic wound therapy as of the effective dates noted above.

Multiple-Seizure Electroconvulsive Therapy (MECT)

We have examined the medical and scientific evidence as well as the additional information obtained as a result of our own investigation. We have determined that the available evidence is adequate to conclude that MECT may pose additional safety risks over conventional electroconvulsive therapy (ECT) for patients with affective disorders or other psychiatric disorders without a balancing clinical benefit.

We have also found that the available evidence, limited to case reports, is not adequate to conclude that non-routine use of MECT is warranted for medical conditions such as neuroleptic malignant syndrome and intractable seizures that do not respond to other therapies.

Therefore, MECT (including the practice of routinely initiating treatment with double-seizure ECT) is considered not reasonable and necessary for the treatment of psychiatric and non-psychiatric conditions in the Medicare population.

Sensory Nerve Conduction Threshold Testing (sNCT)

The available scientific evidence is not adequate to demonstrate the accuracy of sNCT or the accuracy of sNCT as compared to nerve conduction studies (NCS). Unlike NCS, sNCT does not assess the integrity of motor nerves, which is important in evaluating some patient populations, such as diabetics. In addition, it is not evident that sNCT offers any diagnostic advantages over a history and physical examination in detecting the presence of a neuropathy. There are also no clinical studies that we identified that demonstrate that the use of sNCT leads to changes in patient management in a particular Medicare subpopulation. As stated in 42 CFR 410.32, a diagnostic test is not reasonable and necessary unless its results are used by the treating physician (who also orders the test) in the management of the beneficiary's specific medical problem.

In our discussions with experts, we were also unable to identify a subpopulation with whom the results of sNCT would alter medical care. We conclude that the scientific and medical literature does not demonstrate that the use of sNCT to diagnose sensory neuropathies in Medicare beneficiaries is reasonable and necessary.

Noncontact Normothermic Wound Therapy (NNWT)

The medical literature does not support a finding that NNWT heals any wound type better than conventional treatment. While the submitted studies support better healing, due to serious methodological weaknesses, inadequate controls, and a variety of biases, the improved outcomes could also easily disappear in a properly controlled randomized trial.

We have decided to issue a national noncoverage policy for all uses of NNWT for the treatment of wounds because the medical literature is not sufficient to support a NCD.

For complete decision memoranda providing the rationale for these withdrawals, please refer to http://www.cms.gov/​ncdr/​ncdr_​index.asp on the Internet and scroll down to the appropriate topic under completed determinations.

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Authority: Sections 1862, 1869(b)(3), and 1871 of the Social Security Act (42 U.S.C. 1395y, 1395ff(b)(3), and 1395hh).

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(Catalog of Federal Domestic Assistance Program No. 93.773 Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program)

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Dated: May 30, 2003.

Thomas A. Scully,

Administrator, Centers for Medicare & Medicaid Services.

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[FR Doc. 03-18858 Filed 7-24-03; 8:45 am]

BILLING CODE 4120-01-P