(Medicare National Coverage Determinations Manual)

Physicians specializing in movement disorders must be involved in both patient selection and post -procedure care.   Hospital medical centers must have:  a.   Brain imaging equipment (MRI and/or CT) for pre -operative stereotactic localization and targeting of the surgical site(s);   b.   Operating rooms with all necessary equipment for stereotactic surgery; and   c.   Support services necessary for care of patients undergoing this procedure and any potential complications arising intraoperatively or postoperatively.   160.25 - Multiple Electroconvulsive Therapy (MECT)  (Rev. 1, 10- 03-03) CIM -  35-103  The clinical effectiveness of the multiple -seizure electroconvulsive therapy has not been verified by scientifically controlled studies.  In addition, studies have demonstrated an increased risk of adverse effects with multiple seizures.  Accordingly, MECT cannot be considered reasonable and necessary and is not covered by the Medicare program.  Effective for services provided on or after April 1, 2003.  160.26 - Cavernous Nerves Electrical Stimulation with Penile Plethysmography - Effective August 24, 2006  (Rev.61, Issued: 11- 24-06, Effective: 08 -24-06, Implementation: 01- 08-07)  A. General   In nerve -sparing prostatic and colorectal surgical procedures, the assessment of the function of the cavernous nerves by direct application of electrical stimulation with penile plethysmography is a diagnostic test, also referred to as cavernosal nerve mapping, which may be performed to assess the integrity of the cavernous nerves.  Through an open or laparoscopic procedure, the surgeon may want to assess the function of the cavernous nerves by stimulating the most distal end of the nerve that can be locate d by using an electrical nerve stimulator.  The presence of a response and the degree of the response may be used to provide the surgeon with a more realistic assessment of the chance of the patient regaining potency and assist in choosing appropriate ther apy.  B. Nationally Covered Indications   Not applicable.   C. Nationally Non -Covered Indications   Effective August 24, 2006, Cavernous Nerves Electrical Stimulation with penile plethysmography is non-covered under Medicare.  CMS reviewed the evidence and determined that this test is not reasonable and necessary for Medicare beneficiaries undergoing nerve -sparing prostatic or colorectal surgical procedures.   D. Other  Also see 20.14, Plethysmograthy.  (This NCD last reviewed September 2006.)   160.27  Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP)  (Rev. 149, Issued: 11- 30-12, Effective: 06 -08-12, Implementation: 01- 07-13)  The TENS is a type of electrical nerve stimulator that is employed to treat chronic intractable pain.  This stimulator is attached to the surface of the patients skin over the peripheral nerve to be stimulated.  It may be applied in a variety of settings (in the patients home, a physicians office, or in an outpatient clinic).  Payment for TENS may be made under the durable medical equipment benefit.  A. General   For the purposes of this decision chronic low back pain (CLBP) is defined as:   1. an episode of low back pain that has persisted for three months or longer; and  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. Nationally Covered Indications   Effective June 8, 2012, the Centers for Medicare & Medicaid Services (CMS) will allow coverage for Transcutaneous Electrical Nerve Stimulation (TENS) for CLBP only when all of the following conditions are met.   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 (the Act) subject to all of the following conditions:   1. Coverage under this section 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:   a. The principal purpose of the research study is to test whether a particular intervention potentially improves the participants health outcomes.   b. 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.   c. The research study does not unjustifiably duplicate existing studies.   d. The research study design is appropriate to answer the research que stion being asked in the study.  e. The research study is sponsored by an organization or individual capable of executing the proposed study successfully.   f. 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.   g. All aspects of the research study are conducted according to appropriate standards of scientific integr ity (see http://www.icmje.org).   h. The research study has a written protocol that clearly addresses, or incorporates by reference, the standards listed here as Medicare requirements for CED coverage.   i. 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.   j. The clinical research study is registered on the ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollm ent of the first study subject.   k. 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 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 po pulations, 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.   C. Nationally Non- Covered Indications   TENS is not reasonable and necessary for the treatment of CLBP under section 1862(a)(1)(A) of the Act.   D. Other