evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
160.23 - Sensory Nerve Conduction Threshold Tests (sNCTs) (Effective April 1, 2004)  (Rev. 15, 06- 18-04)  A.  General   The sNCT is a psychophysical assessment of both central and peripheral nerve functions. It measures the detection threshold of accurately calibrated sensory stimuli.  This procedure is intended to evaluate and quantify function in both large and small cali ber fibers for the purpose of detecting neurologic disease.  Sensory perception and threshold detection are dependent on the integrity of both the peripheral sensory apparatus and peripheral -central sensory pathways.  In theory, an abnormality detected by this procedure may signal dysfunction anywhere in the sensory pathway from the receptors, the sensory tracts, the primary sensory cortex, to the association cortex.   This procedure is different and distinct from assessment of nerve conduction velocity, amplitude and latency.  It is also different from short -latency somatosensory evoked potentials.   Effective October 1, 2002, CMS initially concluded that there was insufficient scientific or clinical evidence to consider the sNCT test and the device used in performing this test reasonable and necessary within the meaning of section 1862(a)(1)(A) of the  law.   Therefore, sNCT was noncovered.   Effective April 1, 2004, based on a reconsideration of current Medicare policy for sNCT, CMS concludes that the use of any type of sNCT device (e.g., current output type device used to perform current perception threshold (CPT), pain perception threshold (PPT), or pain tolerance threshold (PTT) testing or voltage input type device used for voltage -nerve conduction threshold (v- NCT) testing) to diagnose sensory neuropathies or radiculopathies in Medicare beneficiaries is not reasonable and necessary.   B.  Nationally Covered Indications   Not applicable.   C.  Nationally Noncovered Indications   All uses of sNCT to diagnose sensory neuropathies or radiculopathies are noncovered.   (This NCD last reviewed June 2004.)   160.24  Deep Brain Stimulation for Essential Tremor and Parkinsons Disease  (Rev. 1, 10- 03-03) CIM  65- 19
(Medicare National Coverage Determinations Manual)
(This NCD last reviewed June 2004.)   160.24  Deep Brain Stimulation for Essential Tremor and Parkinsons Disease  (Rev. 1, 10- 03-03) CIM  65- 19  Effective for services furnished on or after April 1, 2003, Medicare will cover unilateral or bilateral thalamic ventralis intermedius nucleus (VIM) deep brain stimulation (DBS) for the treatment of essential tremor (ET) and/or Parkinsonian tremor and unil ateral or bilateral subthalamic nucleus (STN) or globus pallidus interna (GPi) DBS for the treatment of Parkinsons disease (PD) only under the following conditions:   1. Medicare will only consider DBS devices to be reasonable and necessary if they are Food and Drug Administration (FDA) approved devices for DBS or devices used in accordance with FDA approved protocols governing Category B Investigational Device Exemptio n (IDE) DBS clinical trials.   2. For thalamic VIM DBS to be considered reasonable and necessary, patients must meet all of the following criteria:   a. Diagnosis of ET based on postural or kinetic tremors of hand(s) without other neurologic signs, or diagnosis of idiopathic PD (presence of at least 2 cardinal PD features (tremor, rigidity or bradykinesia)) which is of a tremor - dominant form.  b. Marked disabling tremor of at least level 3 or 4 on the Fahn- Tolosa -Marin Clinical Tremor Rating Scale (or equivalent scale) in the extremity intended for treatment, causing significant limitation in daily activities despite optimal medical therapy.   c. Willingness and ability to cooperate during conscious operative procedure, as well as during post -surgical evaluations, adjustments of medications and stimulator settings.   3. For STN or GPi DBS to be considered reasonable and necessary, patients must meet all of the following criteria:   a. Diagnosis of PD based on the presence of at least 2 cardinal PD features (tremor, rigidity or bradykinesia).   b. Advanced idiopathic PD as determined by the use of Hoehn and Yahr stage or Unified Parkinsons Disease Rating Scale (UPDRS) part III motor subscale.  c. L-dopa responsive with clearly defined on periods.
(Medicare National Coverage Determinations Manual)
d. Persistent disabling Parkinsons symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling off periods) despite optimal medical therapy.   e. Willingness and ability to cooperate during conscious operative procedure, as well as during post -surgical evaluations, adjustments of medications and stimulator settings.   The DBS is not reasonable and necessary and is not covered for ET or PD patients with any of the following:   1. Non-idiopathic Parkinsons disease or Parkinsons Plus syndromes.  2. Cognitive impairment, dementia or depression which would be worsened by or would interfere with the patients ability to benefit from DBS.   3. Current psychosis, alcohol abuse or other drug abuse.  Structural lesions such as basal ganglionic stroke, tumor or vascular malformation as etiology of the movement disorder.   Previous movement disorder surgery within the affected basal ganglion.  Significant medical, surgical, neurologic or orthopedic co- morbidities contraindicating DBS surgery or stimulation.  Patients who undergo DBS implantation should not be exposed to diathermy (deep heat treatment including shortwave diathermy, microwave diathermy and ultrasound diathermy) or any type of MRI which may adversely affect the DBS system or adversely affect the brain around the implanted electrodes.   The DBS should be performed with extreme caution in patients with cardiac pacemakers or other electronically controlled implants which may adversely affect or be affected by the DBS system.   For DBS lead implantation to be considered reasonable and necessary, providers and facilities must meet all of the following criteria:   Neurosurgeons must:   a.  Be properly trained in the procedure;   b.  Have experience with the surgical management of movement disorders, including DBS therapy; and   c.  Have experience performing stereotactic neurosurgical procedures.   Operative teams must have training and experience with DBS systems, including knowledge of anatomical and neurophysiological characteristics for localizing the targeted nucleus, surgical and/or implantation techniques for the DBS system, and operational an d functional characteristics of the device.   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);
(Medicare National Coverage Determinations Manual)
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.)
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
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
(Medicare National Coverage Determinations Manual)
See 160.13 for an explanation of coverage of medically necessary supplies for the effective use of TENS.  See 160.7.1 for an explanation of coverage for assessing patients suitability for electrical nerve stimulation therapy.  See 10.2 for an explanation of coverage of transcutaneous electrical nerve stimulation (TENS) for acute post -operative pain.  Please note, 280.13Transcutaneous Electrical Nerve Stimulators (TENS) NCD has been removed from the NCD manual and incorporated into NCD 160.27   (This NCD last reviewed June 2012.)  Transmittals Issued for this Chapter  Rev #  Issue Date  Subject  Impl Date  CR#  R12299NCD  10/12/2023  An Omnibus CR to Implement Policy Updates in the CY 2023 PFS Final Rule, Including (1) Removal of Selected NCDs (NCD 160.22 Ambulatory EEG Monitoring), and, (2) Expanding Coverage of Colorectal Cancer Screening - Full Agile Pilot CR  11/13/2023  13017  R11892NCD  03/09/2023  Technical Revisions Only to the National Coverage Determination (NCD) Manual  04/10/2023  13105  R11865NCD  02/16/2023  An Omnibus CR to Implement Policy Updates in the CY 2023 PFS Final Rule, Including (1) Removal of Selected NCDs (NCD 160.22 Ambulatory EEG Monitoring), and, (2) Expanding Coverage of Colorectal Cancer Screening - Full Agile Pilot CR  - Rescinded and replaced by Transmittal 1 2299  02/27/2023  13017  R11824NCD  01/27/2023  An Omnibus CR to Implement Policy Updates in the CY 2023 PFS Final Rule, Including (1) Removal of Selected NCDs (NCD 160.22 Ambulatory EEG Monitoring), and, (2) Expanding Coverage of Colorectal Cancer Screening - Full Agile Pilot CR - Rescinded and replaced by Transmittal 10865  02/27/2023  13017  R10891NCD  07/20/2021  National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy - This CR Rescinds and Fully Replaces CR 11783.  09/20/2021  12177  R10796NCD  05/20/2021  National Coverage Determination
(Medicare National Coverage Determinations Manual)
Chimeric Antigen Receptor (CAR) T-cell Therapy - This CR Rescinds and Fully Replaces CR 11783.  09/20/2021  12177  R10796NCD  05/20/2021  National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy - This CR Rescinds and Fully Replaces CR 11783. - Rescinded and replaced by Transmittal 10891  07/23/2021  12177  R10797NCD  05/20/2021  National Coverage Determination (NCD) Removal  06/22/2021  12254  R10346NCD  09/11/2020  National Coverage Determination (NCD 90.2): Next Generation Sequencing (NGS) for Medicare Beneficiaries with Germline (Inherited) Cancer  11/13/2020  10837  R10199NCD  06/23/2020  National Coverage Determination (NCD) 160.18 Vagus Nerve Stimulation (VNS)  07/22/2020  11461  R10145NCD  05/22/2020  National Coverage Determination (NCD) 160.18 Vagus Nerve Stimulation (VNS) - Rescinded and replaced by Transmittal 10199  07/22/2020  11461  R215NCD  04/10/2019  National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS)  04/08/2019  10878  R214NCD  03/06/2019  National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS) )- Rescinded and replaced by Transmittal 215  04/08/2019  10878  R210NCD  11/30/2018  National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS)- Rescinded and replaced by Transmittal 214  03/08/2019  10878  R200NCD  07/25/2017  Percutaneous Image -guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS)  06/27/2017  10089  R199NCD  07/11/2017  Percutaneous Image -guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS)   Rescinded and replaced by Transmittal 200  08/11/2017  10089  R196NCD
(Medicare National Coverage Determinations Manual)
Image -guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS)   Rescinded and replaced by Transmittal 200  08/11/2017  10089  R196NCD  05/26/2017  Percutaneous Image -guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS)   Rescinded and replaced by Transmittal 199  06/27/2017  10089  R194NCD  03/03/2017  Gender Dysphoria and Gender Reassignment Surgery  04/04/2017  9981  R193NCD  07/01/2016  Stem Cell Transplantation for Multiple Myeloma, Myelofibrosis, Sickle Cell Disease, and Myelodysplastic Syndromes  10/03/2016  9620  R191NCD  04/29/2016  Stem Cell Transplantation for Multiple Myeloma, Myelofibrosis, Sickle Cell Disease, and Myelodysplastic Syndromes  Rescinded and replaced by Transmittal 193  10/03/2016  9620  R181NCD  03/27/2015  Removal of Multiple National Coverage Determinations Using Expedited Process  04/06/2015  9095  R180NCD  03/06/2015  Removal of Multiple National Coverage Determinations Using Expedited Process  Rescinded and replaced by Transmittal 181  04/06/2015  9095  R173NCD  09/04/2014  Pub 100 -03, Chapter 1, Language -only Update  Upon Implementation of ICD -10 8506  R169NCD  06/27/2014  Invalidation of National Coverage Determination 140.3 - Transsexual Surgery  06/29/2014  8825  R167NCD  05/16/2014  Percutaneous Image -guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS)  10/06/2014  8757  R165NCD  04/15/2014  Aprepitant for Chemotherapy Induced Emesis  07/07/2014  8418  R163NCD  02/21/2014  Aprepitant  for Chemotherapy Induced Emesis  Rescinded and replaced by Transmittal 165  07/07/2014  8418  R159NCD  02/05/2014  Pub 100 -03, Chapter 1, Language -only Update  Rescinded and replaced by
(Medicare National Coverage Determinations Manual)
Chemotherapy Induced Emesis  Rescinded and replaced by Transmittal 165  07/07/2014  8418  R159NCD  02/05/2014  Pub 100 -03, Chapter 1, Language -only Update  Rescinded and replaced by Transmittal 173  10/01/2014  8506  R158NCD  12/23/2013  Bariatric Surgery for Treatment of Co -Morbid Conditions Related to Morbid Obesity  12/17/2013  8484  R157NCD  11/15/2013  Bariatric Surgery for Treatment of Co -Morbid Conditions Related to Morbid Obesity  Rescinded and replaced by Transmittal 158  12/17/2013  8484  R150NCD  01/29/2013  Bariatric Surgery for the Treatment of Morbid Obesity National Coverage Determination, Addition of Laparoscopic Sleeve Gastrectomy (LSG)  02/28/2013  8028  R149NCD  11/30/2012  Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP)  01/07/2013  7836  R148NCD  11/09/2012  Bariatric Surgery for the Treatment of Morbid Obesity National Coverage Determination, Addition of Laparoscopic Sleeve Gastrectomy (LSG)  Rescinded and replaced by Transmittal 150  12/10/2012  8028  R144NCD  08/03/2012  Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP)  Rescinded and replaced by Transmittal 149  01/07/2013  7836  143NCD  05/18/2012  Extracorporeal Photopheresis (ICD -10) 10/01/2012  7806  R140NCD  01/06/2012  Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer  08/08/2011  7431  R136NCD  11/02/2011  Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer  Rescinded and replaced by Transmittal 140  08/08/2011  7431  R133NCD  07/08/2011  Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer  Rescinded and replaced by Transmittal 136  08/08/2011  7431  R127NCD  10/08/2010  Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for