evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
 The patient cannot manage without the conductive garment for the treatment of chronic intractable pain because the areas or sites to be stimulated are inaccessible with the use of conventional electrodes, adhesive tapes and lead wires;    The patient has a documented medical condition such as skin problems that preclude the application of conventional electrodes, adhesive tapes and lead wires;    The patient requires electrical stimulation beneath a cast either to treat disuse atrophy, where the nerve supply to the muscle is intact, or to treat chronic intractable pain; or    The patient has a medical need for rehabilitation strengthening (pursuant to a written plan of rehabilitation) following an injury where the nerve supply to the muscle is intact.   A conductive garment is not covered for use with a TENS device during the trial period specified in 160.3 unless:   4. The patient has a documented skin problem prior to the start of the trial period; and   5. The A/B MAC (B)'s medical consultants are satisfied that use of such an item is medically necessary for the patient.   (See conditions for coverage of the use of TENS in the diagnosis and treatment of chronic intractable pain in 160.3, 160.13, and 160.27, and the use of NMES in the treatment of disuse atrophy in 150.4.)   160.14 - Invasive Intracranial Pressure Monitoring  (Rev. 1, 10- 03-03) CIM 35 -62  Invasive intracranial pressure monitoring is a safe and effective therapeutic tool used to monitor intracranial pressure.  It is usually used for patients suffering from head injuries, subarachnoid hemorrhage, intracerebral hemorrhage, Reyes syndrome, or posthypoxic, metabolic, and viral encephalopathies.  It is usually performed in specialized intensive care units for neurosurgical and neurologic patients.  It is a covered procedure when reasonable and necessary for the individual patient.  160.15 - Electrotherapy for Treatment of Facial Nerve Palsy (Bells Palsy)  (Rev. 1, 10- 03-03) CIM 35 -72  Not Covered
(Medicare National Coverage Determinations Manual)
Not Covered   Electrotherapy for the treatment of facial nerve paralysis is the application of electrical stimulation to affected facial muscles to provide muscle innervation with the intention of preventing muscle degeneration.  A device that generates an electrical cu rrent with controlled frequency, intensity, wave form and type (galvanic or faradic) is used in combination with a pad electrode and a hand applicator electrode to provide electrical stimulation.   Electrotherapy for the treatment of facial nerve paralysis, commonly known as Bells Palsy, is not covered under Medicare because its clinical effectiveness has not been established.   160.16 - Vertebral Axial Decompression (VAX -D) (Rev. 1, 10-03-03) CIM 35 -97  Not Covered  Vertebral axial decompression is performed for symptomatic relief of pain associated with lumbar disk problems.  The treatment combines pelvic and/or cervical traction connected to a special table that permits the traction application.  There is insufficie nt scientific data to support the benefits of this technique.  Therefore, VAX-D is not covered by Medicare.   160.17 - L-Dopa (Rev. 1, 10-03-03) CIM 45 -1  A.  Part A Payment for L-Dopa and Associated Inpatient Hospital Service  A hospital stay and related ancillary services for the administration of L- Dopa are covered if medically required for this purpose.  Whether a drug represents an allowable inpatient hospital cost during such stay depends on whether it meets the definition of a drug in 1861(t) of the Act; i.e., on its inclusion in the compendia named in the Act or approval by the hospitals pharmacy and drug therapeutics (P&DT) or equivalent committee.  (Levodopa (L-Dopa) has been favorably evaluated for the treatment of Parkinsonism by A.M.A. Drug Evaluations, First Edition 1971, the replacement compendia for New Drugs.")
(Medicare National Coverage Determinations Manual)
Inpatient hospital services are frequently not required in many cases when L-Dopa therapy is initiated.  Therefore, determine the medical need for inpatient hospital services on the basis of medical facts in the individual case.  It is not necessary to hospitalize the typical, well-functioning, ambulatory Parkinsonian patient who has no concurrent disease at the start of L -Dopa treatment.  It is  reasonable to provide inpatient hospital services for Parkinsonian patients with concurrent diseases, particularly of the cardiovascular, gastrointestinal, and neuropsychiatric systems.  Although many patients require hospitalization for a period of under two weeks, a 4-week period of inpatient care is not unreasonable.  Laboratory tests in connection with the administration of L-Dopa - The tests medically warranted in connection with the achievement of optimal dosage and the control of the side effects of L -Dopa include a complete blood count, liver function tests such as SGOT, SGPT, and/or alkaline phosphatase, BUN or creatinine and urinalysis, blood sugar, and electrocardiogram.
(Medicare National Coverage Determinations Manual)
Whether or not the patient is hospitalized, laboratory tests in certain cases are reasonable at weekly intervals although some physicians prefer to perform the tests much less frequently.  Physical therapy furnished in connection with administration of L -Dopa -  Where, following administration of the drug, the patient experiences a reduction of rigidity which permits the reestablishment of a restorative goal for him/her, physical therapy services required to enable him/her to achieve this goal are payable provided they require the skills of a qualified physical therapis t and are furnished by or under the supervision of such a therapist.  However, once the individuals restoration potential has been achieved, the services required to maintain him/her at this level do not generally require the skills of a qualified physica l therapist.  In such situations, the role of the therapist is to evaluate the patients needs in consultation with his/her physician and design a program of exercise appropriate to the capacity and tolerance of the patient and treatment objectives of the physician, leaving to others the actual carrying out of the program.  While the evaluative services rendered by a qualified physical therapist are payable as physical therapy, services furnished by others in connection with the carrying out of the maintena nce program established by the therapist are not.  (See the Medicare Benefit Policy Manual, Chapter 1, Inpatient Hospital Services, 30.)   B.  Part A Reimbursement for L -Dopa Therapy in SNFs   Initiation of L -Dopa therapy can be appropriately carried out in the skilled nursing facility (SNF) setting, applying the same guidelines used for initiation of L -Dopa therapy in the hospital, including the types of patients who should be covered for inpat ient services, the role of physical therapy, and the use of laboratory tests.  (See subsection A.)
(Medicare National Coverage Determinations Manual)
Where inpatient care is required and L -Dopa therapy is initiated in the SNF, limit the stay to a maximum of four weeks; but in many cases the need may be no longer than one or two weeks, depending upon the patients condition.  However, where L -Dopa therap y is begun in the hospital and the patient is transferred to a SNF for continuation of the therapy, a combined length of stay in hospital and SNF of no longer than four weeks is reasonable (i.e., 1- week hospital stay followed by three weeks SNF stay; or tw o weeks hospital stay followed by two weeks SNF stay; etc.).  Medical need must be demonstrated in cases where the combined length of stay in hospital and SNF is longer than four weeks.  The choice of hospital or SNF, and the decision regarding the relative length of time spent in each, should be left to the medical judgment of the treating physician.  See the Medicare Benefit Policy Manual, Chapter 8, Coverage of Extended Care (SNF) Services Under Hospital Insurance, 50.5.   C.  L -Dopa Coverage Under Part B   Part B reimbursement may not be made for the drug L -Dopa since it is a self -administrable drug.  (See the Medicare Benefit Policy Manual, Chapter 6, Hospital Services Covered Under Part B, 20.4.1.)  However, physician services rendered in connection wit h its administration and control of its side effects are covered if determined to be reasonable and necessary.  Initiation of L -Dopa therapy on an outpatient basis is possible in most cases.  Visit frequency ranging from every week to every 2 or 3 months is acceptable.  However, after half a year of therapy, visits more frequent than every month would usually not be reasonable.   160.18 - Vagus Nerve Stimulation (VNS)   (Rev. 10199, Issued: 06-23-2020, Effective: -02-15- 2019, Implementation: 07-22-2020)  A. General
(Medicare National Coverage Determinations Manual)
A. General   Vagus Nerve Stimulation (VNS) is a pulse generator, similar to a pacemaker, that is surgically implanted under the skin of the left chest and an electrical lead (wire) is connected from the generator to the left vagus nerve. Electrical signals are sent fro m the battery -powered generator to the vagus nerve via the lead. These signals are in turn sent to the brain. The Food and Drug Administration (FDA) approved VNS for treatment of refractory epilepsy in 1997 and for resistant depression in 2005.  B. Nationally Covered Indications  Effective for services performed on or after July 1, 1999, VNS is reasonable and necessary for patients with medically refractory partial onset seizures for whom surgery is not recommended or for whom surgery has failed.  Effective for services performed on or after February 15, 2019, the Centers for Medicare & Medicaid Services (CMS) will cover FDA -approved VNS devices for treatment resistant depression (TRD) through Coverage with Evidence Development (CED) when offered in  a CMS -approved, double-blind, randomized, placebo- controlled trial with a follow-up duration of at least one year with the possibility of extending the study to a prospective longitudinal study when the CMS-approved, double-blind, randomized placebo -contr olled trial has completed enrollment, and there are positive interim findings.   Each study must be approved by CMS and as a fully-described, written part of its protocol, must address whether VNS improves health outcomes for TRD patients compared to a control group, by answering all of the following research questions below.  The details of the prospective longitudinal study must be described in the original protocol for the double-blind, randomized, placebo- controlled trial.   Response is defined as a  50% improvement in depressive symptoms from baseline, as measured by a guideline recommended depression scale assessment tool.   Remission is defined as being below the threshold on a guideline recomm ended depression scale assessment tool.   The following research questions must be addressed in a separate analysis for patients with bipolar and unipolar disease.  Research Questions:
(Medicare National Coverage Determinations Manual)
Research Questions:    What is the rate of response (defined as person months of response/total months of study participation)?  What is the rate of remission (defined as person months of response/total months of study participation)?  What is the time from treatment until response scores are first achieved?   What is the time from treatment until remission scores are first achieved?   What are the population distributions of the maximum months of response, both consecutive and overall, separately?   What are the population distributions of the maximum months of remission, both consecutive and overall, separately?   What are the patient variables associated with successful treatment of TRD with VNS?   What are the observed harms?   What are the changes in disability, quality of life, general psychiatric status, and suicidality?  Patient Criteria:  The following criteria must be used to identify patients demonstrating TRD:   The patient must be in a major depressive disorder (MDD) episode for  two years or have had at least four episodes of MDD, including the current episode.  In order to confirm the patient has MDD, accepted diagnostic criteria from the most current edition of the Diagnostic and Statistical Manual for Mental Disorder (DSM) and a structured clinical assessment are to be used.   The patients depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose.  The patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device.  Patients must maintain a stable medication regimen for at least four weeks before device implantation.   If patients with bipolar disorder are included, the condition must be carefully characterized.  Patients must not have:   Current or lifetime history of psychotic features in any MDE;  Current or lifetime history of schizophrenia or schizoaffective disorder;  Current or lifetime history of any other psychotic disorder;   Current or lifetime history of rapid cycling bipolar disorder;   Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder;   Current suicidal intent; or,   Treatment with another investigational device or investigational drugs.
(Medicare National Coverage Determinations Manual)
Individuals who receive placebo VNS will be offered active VNS at the end of the trial. In addition, CMS will review studies to determine if they meet the 13 criteria listed below.  If CMS determines that they meet these criteria, the study will be posted on CMS CED website ( https://www.cms.gov/Medicare/Coverage/Coverage- w ith-Evidence-Development/index.html ).
(Medicare National Coverage Determinations Manual)
a) The principal purpose of the study is to test whether the item or service meaningfully improves health outcomes of affected beneficiaries who are represented by the enrolled subjects.  b) The rationale for the study is well supported by available scientific and medical evidence.  c) The study results are not anticipated to unjustifiably duplicate existing knowledge.  d) The study design is methodologically appropriate and the anticipated number of enrolled subjects is sufficient to answer the research question(s) being asked in the National Coverage Determination.  e) The study is sponsored by an organization or individual capable of completing it successfully.  f) The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it is also in compliance with 21 CFR Parts 50 and 56. In addition, to further enhance the protection of human subjects in studies conducted under CED, the study must provide and obtain meaningful informed consent from patients regarding the risks associated with the study items and/or services, and the use and eventual disposition of the collected data. g) All aspects of the study are conducted according to appropriate standards of scientific integrity.  h) The study has a written protocol that clearly demonstrates adherence to the standards listed here as Medicare requirements.  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 Agency for Healthcare Quality (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
(Medicare National Coverage Determinations Manual)
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 dedicated 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.
(Medicare National Coverage Determinations Manual)
Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above- listed standards and address the above- listed research questions.   The principal investigator must submit the complete study protocol, identify the relevant CMS research questions 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. The information will be reviewed, and approved studies will be identified on t he CMS website.   Director, Coverage and Analysis Group Centers for Medicare & Medicaid Services (CMS)  7500 Security Blvd., Mail Stop S3-02-01 Baltimore, MD 21244-1850  C. Nationally Non-Covered Indications  Effective for services performed on or after July 1, 1999, VNS is not reasonable and necessary for all other types of seizure disorders which are medically refractory and for whom surgery is not recommended or for whom surgery has failed.  VNS is non -covered for the treatment of TRD when furnished outside of a CMS-approved CED study.  All other indications of VNS for the treatment of depression are nationally non- covered.   D. Other   Patients implanted with a VNS device for TRD may receive a VNS device replacement if it is required due to the end of battery life, or any other device- related malfunction.   (This NCD last reviewed February 2019.)  160.19 - Phrenic Nerve Stimulator  (Rev. 1, 10-03-03) CIM 65 -13  The implantation of a phrenic nerve stimulator is covered for selected patients with partial or complete respiratory insufficiency.
(Medicare National Coverage Determinations Manual)
The implantation of a phrenic nerve stimulator is covered for selected patients with partial or complete respiratory insufficiency.   The phrenic nerve stimulator provides electrical stimulation of the patients phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation (a state in which an abnormally low amount of air enters the lungs).  The device has been used successfully to treat hypoventilation caused by a variety of conditions, including respiratory paralysis resulting from lesions of the brain stem and cervical spinal cord and chronic pulmonary disease with ventilatory insufficiency.  The phrenic nerve stimulator is intended to be an alternative to management of patients with respiratory insufficiency who are dependent upon the usual therapy of intermittent or permanent use of a mechanical ventilator as well as maintenance of a p ermanent tracheotomy stoma.  However, an implanted phrenic nerve stimulator can be effective only if the patient has an intact phrenic nerve and diaphragm.  Moreover, nerve injury may occur during the surgical procedure and if sufficient injury is incurred, the device will not prove useful to the patient.  Consequently, it is possible for such a device to be indicated for a patient but, due to injury sustained during implant, fail to assist the patient, resulting in a return to the use of mechanical ventilation.   Cross reference to 160.7, Electrical Nerve Stimulators.   160.20 - Transfer Factor for Treatment of Multiple Sclerosis  (Rev. 1, 10-03-03) CIM 45 -17  Transfer factor is the dialysate of an extract from sensitized leukocytes which increases cellular immune activity in the recipient.  It is not covered as a treatment for multiple sclerosis because its use for the purpose is still experimental.
(Medicare National Coverage Determinations Manual)
Transfer factor is the dialysate of an extract from sensitized leukocytes which increases cellular immune activity in the recipient.  It is not covered as a treatment for multiple sclerosis because its use for the purpose is still experimental.   160.21 - Telephone Transmission of EEGs  (Rev. 1, 10-03-03) CIM - 50-39  Telephone transmission of electroencephalograms (EEGs) is covered as a physicians service, or as incident to a physicians service when reasonable and necessary for the individual patient, under appropriate circumstances.  The service is safe, and may save time and cost in sending EEGs from remote areas without special competence in neurology, neurosurgery, and electroencephalography, by avoiding the need to transport patients to large medical centers for standard EEG testing.   Telephone transmission of EEGs has been most helpful in the following clinical situations:    Altered consciousness, such as stuporous, semicomatose, or comatose states;    A typical seizure variants in patients experiencing bizarre, distressing symptoms as seen with spike and wave stupor or other forms of seizure disorders;    Diagnosis of a suspected intracranial tumor;    Head injury, where a subdural hematoma may be identified;    Headaches during the acute phase where, for instance, in migraine syndrome, abnormal responses may be seen.   Telephonically transmitted EEGs should not be used for determining electrical inactivity (i.e., brain death), because of unavoidable signal interference.   160.22 - Ambulatory EEG Monitoring (Retired)  (Rev. 12299; Issued:10- 12-23; Effective:01 -01-23; Implementation:11 -13-23)  Effective January 1, 2023, the Centers for Medicare & Medicaid Services removed the national coverage determination (NCD) for Ambulatory EEG Monitoring. In the absence of an NCD, coverage determinations will be made by the Medicare Administrative Contractors under section 1862(a)(1)(A) of the Social Security Act.   160.23 - Sensory Nerve Conduction Threshold Tests (sNCTs) (Effective April 1, 2004)  (Rev. 15, 06- 18-04)  A.  General