[ddj] CMS has the right stuff

Mon Jun 11 18:19:59 UTC 2012

  Decision Memo for Transcutaneous Electrical Nerve Stimulation for Chronic
Low Back Pain (CAG-00429N)

Decision Summary

A. Definitions
For the purposes of this decision CLBP is defined as:

1. an episode of low back pain that has persisted for three months or
longer; and

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2. is not a manifestation of a clearly defined and generally recognizable
primary disease entity. For example, there are cancers that, through
metastatic spread to the spine or pelvis, may elicit pain in the lower back
as a symptom; and certain systemic diseases such as rheumatoid arthritis
and multiple sclerosis manifest many debilitating symptoms of which low
back pain is not the primary focus.

B. TENS is not reasonable and necessary for the treatment of CLBP under
section 1862(a)(1)(A) of the Social Security Act.

C. In order to support additional research on the use of TENS for CLBP, we
will cover this item under section 1862(a)(1)(E) of the Social Security Act
subject to all of the following conditions.

   1.

   Coverage under this section C expires three years after the publication
   of this decision on the CMS website.
    2.

   The beneficiary is enrolled in an approved clinical study meeting all of
   the requirements below. The study must address one or more

   aspects of the following questions in a randomized, controlled design
   using validated and reliable instruments. This can include randomized
   crossover designs when the impact of prior TENS use is appropriately
   accounted for in the study protocol.

   i. Does the use of TENS provide clinically meaningful reduction in pain
   in Medicare beneficiaries with CLBP?
   ii. Does the use of TENS provide a clinically meaningful improvement of
   function in Medicare beneficiaries with CLBP?

   iii. Does the use of TENS impact the utilization of other medical
   treatments or services used in the medical management of CLBP?

These studies must be designed so that the patients in the control and
comparison groups receive the same concurrent treatments and either sham
(placebo) TENS or active TENS intervention.

The study must adhere to the following standards of scientific integrity
and relevance to the Medicare population:

   1.

   The principal purpose of the research study is to test whether a
   particular intervention potentially improves the participants’ health
   outcomes.
    2.

   The research study is well supported by available scientific and medical
   information or it is intended to clarify or establish the health outcomes
   of interventions already in common clinical use.
    3.

   The research study does not unjustifiably duplicate existing studies.
    4.

   The research study design is appropriate to answer the research question
   being asked in the study.
    5.

   The research study is sponsored by an organization or individual capable
   of executing the proposed study successfully.
    6.

   The research study is in compliance with all applicable Federal
   regulations concerning the protection of human subjects found at 45 CFR
   Part 46. If a study is regulated by the Food and Drug Administration (FDA),
   it must be in compliance with 21 CFR parts 50 and 56.
    7.

   All aspects of the research study are conducted according to appropriate
   standards of scientific integrity (see http://www.icmje.org).
    8.

   The research study has a written protocol that clearly addresses, or
   incorporates by reference, the standards listed here as Medicare

   requirements for CED coverage.
    9.

   The clinical research study is not designed to exclusively test toxicity
   or disease pathophysiology in healthy individuals. Trials of all

   medical technologies measuring therapeutic outcomes as one of the
   objectives meet this standard only if the disease or condition

   being studied is life threatening as defined in 21 CFR § 312.81(a) and
   the patient has no other viable treatment options.
    10.

   The clinical research study is registered on the ClinicalTrials.gov
   website by the principal sponsor/investigator prior to the enrollment of

   the first study subject.
    11.

   The research study protocol specifies the method and timing of public
   release of all prespecified outcomes to be measured including

   release of outcomes if outcomes are negative or study is terminated
   early. The results must be made public within 24 months of the end of data
   collection. If a report is planned to be published in a peer reviewed
   journal, then that initial release may be an abstract that

http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=256

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Decision Memo for Transcutaneous Electrical Nerve Stimulation for Chronic
Low Back Pain (CAG-00429N) 6/9/12 7:20 PM

meets the requirements of the International Committee of Medical Journal
Editors (http://www.icmje.org).
l. The research study protocol must explicitly discuss subpopulations
affected by the treatment under investigation, particularly

traditionally underrepresented groups in clinical studies, how the
inclusion and exclusion criteria effect enrollment of these populations,
and a plan for the retention and reporting of said populations on the
trial. If the inclusion and exclusion criteria are expected to have a
negative effect on the recruitment or retention of underrepresented
populations, the protocol must discuss why these criteria are necessary.

m. The research study protocol explicitly discusses how the results are or
are not expected to be generalizable to the Medicare population to infer
whether Medicare patients may benefit from the intervention. Separate
discussions in the protocol may be necessary for populations eligible for
Medicare due to age, disability or Medicaid eligibility.

Consistent with section 1142 of the Social Security Act, AHRQ supports
clinical research studies that CMS determines meet the above- listed
standards and address the above-listed research questions.

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Decision Memo
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TO:

Administrative File: (CAG #00429N)

FROM:

Louis Jacques, MD
Director, Coverage and Analysis Group

Tamara Syrek Jensen, JD
Deputy Director, Coverage and Analysis Group

James Rollins, MD, MSHA, PhD Director, Division of Items and Devices

Brijet Burton, MPP, MS, PA-C
Lead Analyst, Division of Items and Devices

Rosemarie Hakim, PhD Epidemiologist

Susan Miller, MD Lead Medical Officer

SUBJECT :

Final Decision Memorandum for Transcutaneous Electrical Nerve Stimulation
for Chronic Low Back Pain (CAG-00429N)
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DATE:

June 8, 2012

I. Final Decision: