evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
i. The study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Such studies may meet this requirement 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 studies and registries are registered on the www.ClinicalTrials.gov  website by the principal sponsor/investigator prior to the enrollment of the first study subject. Registries are also registered in the AHRQ Registry of Patient Registries  (RoPR).  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 12 months of the studys primary completion date, which is the date the final subject had final data collection for the primary endpoint, even if the trial does not achieve its primary aim. The results must include number started/completed, summary results for prima ry and secondary outcome measures, statistical analyses, and adverse events. Final results must be reported in a publicly accessibly manner; either in a peer -reviewed scientific journal (in print or on- line), in an on- line publicly accessible registry dedi cated to the dissemination of clinical trial information such as ClinicalTrials.gov, or in journals willing to publish in abbreviated format (e.g., for studies with negative or incomplete  results).  l. The study protocol must explicitly discuss beneficiary subpopulations affected by the item or service 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 in 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 study protocol explicitly discusses how the results are or are not expected to be generalizable to affected beneficiary subpopulations. 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 Act, tAHRQ supports clinical research studies that CMS determines meet the above- listed standards and address the above -listed research questions.
(Medicare National Coverage Determinations Manual)
Consistent with section 1142 of the Act, tAHRQ supports clinical research studies that CMS determines meet the above- listed standards and address the above -listed research questions.  All clinical research study protocols must be reviewed and approved by CMS. The principal investigator must submit the complete study protocol, identify the relevant CMS research question(s) that will be addressed and cite the location of the detailed analysis plan for those questions in the protocol, plus provide a statement addressing how the study satisfies each of the standards of scientific integrity (a. through m. listed above), as well as the investigators contact information, to the address below:  Director, Coverage and Analysis Group Re: PILD CED  Centers for Medicare & Medicaid Services (CMS)  7500 Security Blvd., Mail Stop S3-02-01 Baltimore MD 21244-1850  Email address for protocol submissions: clinicalstudynotification@cms.hhs.gov Email subject line: CED [NCD topic (i.e. PILD)] [name of sponsor/primary investigator]  The information will be reviewed, and approved studies will be identified on the CMS website -https://www.cms.gov/Medicare/Coverage/Coverage- with-Evidence-Development/index.html.  C. Nationally Non- Covered  Indications  Effective for services performed on or after January 9, 2014, PILD for LSS may only be covered under the context of a clinical trial as described in section B above according to section 1862(a)(1)(E) of the Social Security Act.  CMS has determined that PILD for LSS is not reasonable and necessary under section 1862(a)(1)(A) of the Act.   D. Other  Endoscopically assisted laminotomy/laminectomy, which requires open and direct visualization, as well as other open lumbar decompression procedures for LSS are not within the scope of this NCD and coverage is at contractor discretion.   (This NCD last reviewed December 2016.)               150.20  Reserved for Future Use  (Rev.)  160 - Nervous System  (Rev. 1, 10-03-03)  160.1 - Induced Lesions of Nerve Tracts  (Rev. 173, Issued: 09-04- 14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)
(Medicare National Coverage Determinations Manual)
Surgically induced lesions of nerve tracts which involve destruction of nerve tissue are primarily indicated for controlling the chronic or acute pain arising from conditions such as terminal cancer or lumbar degenerative arthritis.  Induced lesions of nerve tracts may be produced by surgical cutting of the nerve (rhizolysis), chemical destruction of the nerve, or by creation of a radio-frequency lesion (electrocautery).  Accordingly, program payment may be made for these denervation procedures when used in selected cases (concurred in by the A/B MACs medical staff) to treat chronic pain.  Note that these procedures differ from those employing implanted electrodes and associated equipment to control pain in that the nerve fibers are ablated rather than stimulated and no electronic equipment is required by the patient after the operation.  160.2 - Treatment of Motor Function Disorders with Electric Nerve Stimulation  (Rev. 1, 10-03-03) CIM 35 -20  Not Covered  While electric nerve stimulation has been employed to control chronic intractable pain for some time, its use in the treatment of motor function disorders, such as multiple sclerosis, is a recent innovation, and the medical effectiveness of such therapy has not been verified by scientifically controlled studies.  Therefore, where electric nerve stimulation is employed to treat motor function disorders, no reimbursement may be made for the stimulator or for the services related to its implantation since this  treatment cannot be considered reasonable and necessary.  See 30.1 and 160.7.  NOTE:  For Medicare coverage of deep brain stimulation for essential tremor and Parkinsons disease, see 160.25.  160.4 - Stereotactic Cingulotomy as a Means of Psychosurgery  (RETIRED) (Rev. 11892; Issued: 03-09- 23; Effective: 04 -10-23; Implementation:04-10-23)    Effective December  18, 2014, NCD 160.4 is  retired.   160.5 - Stereotaxic Depth Electrode Implantation  (Rev. 1, 10-03-03) CIM 50 -40
(Medicare National Coverage Determinations Manual)
Effective December  18, 2014, NCD 160.4 is  retired.   160.5 - Stereotaxic Depth Electrode Implantation  (Rev. 1, 10-03-03) CIM 50 -40  Stereotaxic depth electrode implantation prior to surgical treatment of focal epilepsy for patients who are unresponsive to anticonvulsant medications has been found both safe and effective for diagnosing resectable seizure foci that may go undetected by conventional scalp electroencephalographs (EEGs).  The procedure employs thin wire electrodes which are implanted in the brain of the focal epileptic patient for EEG monitoring.  By taking several readings during seizure activity, the location of the epileptic focus may be found, so that better informed de cisions can be made regarding the surgical treatment of persons with intractable seizures.   160.6 - Carotid Sinus Nerve Stimulator  (RETIRED)  (Rev. 11892; Issued: 03-09- 23; Effective: 04 -10-23; Implementation:04-10-23)    Effective December  18, 2014, NCD 160.6 is  retired.   160.7 - Electrical Nerve Stimulators  (Rev. 173, Issued: 09-04- 14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  Two general classifications of electrical nerve stimulators are employed to treat chronic intractable pain:  peripheral nerve stimulators and central nervous system stimulators.   A.  Implanted Peripheral Nerve Stimulators
(Medicare National Coverage Determinations Manual)
Two general classifications of electrical nerve stimulators are employed to treat chronic intractable pain:  peripheral nerve stimulators and central nervous system stimulators.   A.  Implanted Peripheral Nerve Stimulators   Payment may be made under the prosthetic device benefit for implanted peripheral nerve stimulators.  Use of this stimulator involves implantation of electrodes around a selected peripheral nerve.  The stimulating electrode is connected by an insulated lead to a receiver unit which is implanted under the skin at a depth not greater than 1/2 inch.  Stimulation is induced by a generator connected to an antenna unit which is attached to the skin surface over the receiver unit.  Implantation of electrodes requires surgery and usually necessitates an operating room.  NOTE:  Peripheral nerve stimulators may also be employed to assess a patients suitability for continued treatment with an electric nerve stimulator.  As explained in 160.7.1, such use of the stimulator is covered as part of the total diagnostic service furnished to the beneficiary rather than as a prosthesis.  B.  Central Nervous System Stimulators (Dorsal Column and Depth Brain Stimulators)  The implantation of central nervous system stimulators may be covered as therapies for the relief of chronic intractable pain, subject to the following conditions:  1.  Types of Implantations  There are two types of implantations covered by this instruction:   Dorsal Column (Spinal Cord) Neurostimulation - The surgical implantation of neurostimulator electrodes within the dura mater (endodural) or the percutaneous insertion of electrodes in the epidural space is covered.
(Medicare National Coverage Determinations Manual)
 Depth Brain Neurostimulation - The stereotactic implantation of electrodes in the deep brain (e.g., thalamus and periaqueductal gray matter) is covered.  2.  Conditions for Coverage  No payment may be made for the implantation of dorsal column or depth brain stimulators or services and supplies related to such implantation, unless all of the conditions listed below have been met:   The implantation of the stimulator is used only as a late resort (if not a last resort) for patients with chronic intractable pain;   With respect to item a, other treatment modalities (pharmacological, surgical, physical, or psychological therapies) have been tried and did not prove satisfactory, or are judged to be unsuitable or contraindicated for the given patient;   Patients have undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to implantation.  (Such screening must include psychological, as well as physical evaluation);   All the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment training, and follow up of the patient (including that required to satisfy item c) must be available; and    Demonstration of pain relief with a temporarily implanted electrode precedes permanent implantation.   A/B MACs may find it helpful to work with Quality Improvement Organizations to obtain the information needed to apply these conditions to claims.  See the Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 120, and the following sections in this manual, 160.2 and 30.1.  160.7.1 - Assessing Patients Suitability for Electrical Nerve Stimulation Therapy  (Rev. 149, Issued: 11-30-12, Effective: 06-08-12, Implementation: 01-07-13)  Electrical nerve stimulation is an accepted modality for assessing a patients suitability for ongoing treatment with a transcutaneous or an implanted nerve stimulator.  Accordingly, program payment may be made for the following techniques when used to determine the potential therapeutic usefulness of an electrical nerve stimulator:   A.  Transcutaneous Electrical Nerve Stimulation (TENS)
(Medicare National Coverage Determinations Manual)
A.  Transcutaneous Electrical Nerve Stimulation (TENS)   This technique involves attachment of a transcutaneous nerve stimulator to the surface of the skin over the peripheral nerve to be stimulated.   It is used by the patient on a trial basis and its effectiveness in modulating pain is monitored by the physician, or physical therapist.   Generally, the physician or physical therapist is able to determine whether the patient is likely to derive a significant therapeutic benefit from continuous use of a transcutaneous stimulator within a trial period of one month; in a few cases this determ ination may take longer to make.  Document the medical necessity for such services which are furnished beyond the first month.  (See 160.13 for an explanation of coverage of medically necessary supplies for the effective use of TENS.)
(Medicare National Coverage Determinations Manual)
for an explanation of coverage of medically necessary supplies for the effective use of TENS.)   If TENS significantly alleviates pain, it may be considered as primary treatment; if it produces no relief or greater discomfort than the original pain electrical nerve stimulation therapy is ruled out.  However, where TENS produces incomplete relief, further evaluation with percutaneous electrical nerve stimulation may be considered to determine whether an implanted peripheral nerve stimulator would provide significant relief from pain.  Usually, the physician or physical therapist providing the services will furnish the equipment necessary for assessment.   Where the physician or physical therapist advises the patient to rent the TENS from a supplier during the trial period rather than supplying it himself/herself, program payment may be made for rental of the TENS as well as for the services of the physician or physical therapist who is evaluating its use.  However, the combined program payment which is made for the physicians or physical therapists services and the rental of the stimulator from a supplier should not exceed the amount which would be payable for the total service, including the stimulator, furnished by the physician or physical therapist alone.  B. Percutaneous Electrical Nerve Stimulation (PENS)   This diagnostic procedure which involves stimulation of peripheral nerves by a needle electrode inserted through the skin is performed only in a physicians office, clinic, or hospital outpatient department.  Therefore, it is covered only when performed by a physician or incident to physicians service.  If pain is effectively controlled by percutaneous stimulation, implantation of electrodes is warranted.   As in the case of TENS (described in subsection A), generally the physician should be able to determine whether the patient is likely to derive a significant therapeutic benefit from continuing use of an implanted nerve stimulator within a trial period of 1 month. In a few cases, this determination may take longer to make.  The medical necessity for such diagnostic services which are furnished beyond the first month must be documented.
(Medicare National Coverage Determinations Manual)
NOTE:  Electrical nerve stimulators do not prevent pain but only alleviate pain as it occurs.  A patient can be taught how to employ the stimulator, and once this is done, can use it safely and effectively without direct physician supervision.  Consequently, it is inappropriate for a patient to visit his/her physician, physical therapist, or an outpatient clinic on a continuing basis for treatment of pain with electrical nerve stimulation.  Once it is determined that electrical nerve stimulation should be c ontinued as therapy and the patient has been trained to use the stimulator, it is expected that a stimulator will be implanted or the patient will employ the TENS on a continual basis in his/her home.  Electrical nerve stimulation treatments furnished by a physician in his/her office, by a physical therapist or outpatient clinic are excluded from coverage by 1862(a)(1) of the Act.  (See 160.7 for an explanation of coverage of the therapeutic use of implanted peripheral nerve stimulators under the prosthet ic devices benefit.)  See 160.27 for an explanation of coverage of the therapeutic use of TENS under the durable medical equipment benefit.   160.8 - Electroencephalographic Monitoring During Surgical Procedures Involving the Cerebral Vasculature  (Rev. 48, Issued:  03 -17-06; Effective/Implementation Dates:  06 -19-06) CIM 35 -57  Electroencephalographic (EEG) monitoring is a safe and reliable technique for the assessment of gross cerebral blood flow during general anesthesia and is covered under Medicare.  Very characteristic changes in the EEG occur when cerebral perfusion is inadequate for cere bral function.  EEG monitoring as an indirect measure of cerebral perfusion requires the expertise of an electroencephalographer, a neurologist trained in EEG, or an advanced EEG technician for its proper interpretation.
(Medicare National Coverage Determinations Manual)
The EEG monitoring may be covered routinely in carotid endarterectomies and in other neurological procedures where cerebral perfusion could be reduced.  Such other procedures might include aneurysm surgery where hypotensive anesthesia is used or other cerebral vascular procedures where cerebral blood flow may be interrupted.  160.9  Electroencephalographic (EEG) Monitoring During Open -Heart Surgery  (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Effective December  18, 2014, NCD 160.9 is  retired.   160.10 - Evoked Response Tests  (Rev. 1, 10-03-03) CIM 50 -31  Evoked response tests, including brain stem evoked response and visual evoked response tests, are generally accepted as safe and effective diagnostic tools.  These tests measure brain responses to repetitive visual, click or other stimuli.  Program payment may be made for these procedures.  160.12 - Neuromuscular Electrical Stimulator (NMES)  (Rev. 55, Issued: 05-05- 06, Effective: 10 -01-06, Implementation: 10-02-06)  Neuromuscular electrical stimulation (NMES) involves the use of a device which transmits an electrical impulse to the skin over selected muscle groups by way of electrodes. There are two broad categories of NMES. One type of device stimulates the muscle wh en the patient is in a resting state to treat muscle atrophy. The second type is used to enhance functional activity of neurologically impaired patients.  Treatment of Muscle Atrophy  Coverage of NMES to treat muscle atrophy is limited to the treatment of disuse atrophy where nerve supply to the muscle is intact, including brain, spinal cord and peripheral nerves, and other non-neurological reasons for disuse atrophy.  Some examples would be casting or splinting of a limb, contracture due to scarring of soft tissue as in burn lesions, and hip replacement surgery (until orthotic training begins).  (See 160.13 for an explanation of coverage of medically necessary supplies for the effective use of NMES.)
(Medicare National Coverage Determinations Manual)
for an explanation of coverage of medically necessary supplies for the effective use of NMES.)  Use for Walking in Patients with Spinal Cord Injury (SCI)  The type of NMES that is use to enhance the ability to walk of SCI patients is commonly referred to as functional electrical stimulation (FES).  These devices are surface units that use electrical impulses to activate paralyzed or weak muscles in precise sequence.  Coverage for the use of NMES/FES is limited to SCI patients for walking, who have completed a training program which consists of at least 32 physical therapy sessions with the device over a period of three months.  The trial period of physical therapy will enable the physician treating the patient for his or her spinal cord injury to properly evaluate the persons ability to use these devices frequently and for the long term.  Physical therapy necessary to perform this training must be directly performed by the physical therapist as part of a one-on-one training program.  The goal of physical therapy must be to train SCI patients on the use of NMES/FES devices to achieve walking, not to reverse or retard muscle atrophy.  Coverage for NMES/FES for walking will be covered in SCI patients with all of the following characteristics:   1. Persons with intact lower motor unite (L1 and below) (both muscle and peripheral nerve);   2. Persons with muscle and joint stability for weight bearing at upper and lower extremities that can demonstrate balance and control to maintain an upright support posture independently;   3. Persons that demonstrate brisk muscle contraction to NMES and have sensory perception electrical stimulation sufficient for muscle contraction;  4. Persons that possess high motivation, commitment and cognitive ability to use such devices for walking;   5. Persons that can transfer independently and can demonstrate independent standing tolerance for at least 3 minutes;  6. Persons that can demonstrate hand and finger function to manipulate controls;   7. Persons with at least 6 -month post recovery spinal cord injury and restorative surgery;   8. Persons with hip and knee degenerative disease and no history of long bone fracture secondary to osteoporosis; and   9. Persons who have demonstrated a willingness to use the device long -term.   The NMES/FES for walking will not be covered in SCI patient with any of the following:   1. Persons with cardiac pacemakers;   2. Severe scoliosis or severe osteoporosis;   3. Skin disease or cancer at area of stimulation;
(Medicare National Coverage Determinations Manual)
1. Persons with cardiac pacemakers;   2. Severe scoliosis or severe osteoporosis;   3. Skin disease or cancer at area of stimulation;   4. Irreversible contracture; or   5. Autonomic dysflexia.   The only settings where therapists with the sufficient skills to provide these services are employed, are inpatient hospitals; outpatient hospitals; comprehensive outpatient rehabilitation facilities; and outpatient rehabilitation facilities.  The physical therapy necessary to perform this training must be part of a one -on-one training program.  Additional therapy after the purchase of the DME would be limited by our general policies in converge of skilled physical therapy.   (Also reference the Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 220 and 230, and the Medicare Claims Processing Manual, Chapter 5, Part B Outpatient Rehabilitation and CORF Services, 10.1.)   160.13 - Supplies Used in the Delivery of Transcutaneous Electrical Nerve Stimulation (TENS) and Neuromuscular Electrical Stimulation (NMES)  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  Transcutaneous Electrical Nerve Stimulation (TENS) and/or Neuromuscular Electrical Stimulation (NMES) can ordinarily be delivered to patients through the use of conventional electrodes, adhesive tapes and lead wires.  There may be times, however, where it might be medically necessary for certain patients receiving TENS or NMES treatment to use, as an alternative to conventional electrodes, adhesive tapes and lead wires, a form -fitting conductive garment (i.e., a garment  with conductive fibers which are separated from the patients skin by layers of fabric).   A form -fitting conductive garment (and medically necessary related supplies) may be covered under the program only when:   1. It has received permission or approval for marketing by the Food and Drug Administration;   2. It has been prescribed by a physician for use in delivering covered TENS or NMES treatment; and   3. One of the medical indications outlined below is met:    The patient cannot manage without the conductive garment because there is such a large area or so many sites to be stimulated and the stimulation would have to be delivered so frequently that it is not feasible to use conventional electrodes, adhesive tapes and lead wires;