[Federal Register Volume 68, Number 143 (Friday, July 25, 2003)]
[Notices]
[Pages 44088-44089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18858]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3124-WN]


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

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

ACTION: Notice.

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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.

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.

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

[[Page 44089]]

for 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.

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

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


    Dated: May 30, 2003.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 03-18858 Filed 7-24-03; 8:45 am]
BILLING CODE 4120-01-P