evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
-  Digital Subtraction Angiography (DSA)  220.10 -  Portable Hand -Held X -Ray Instrument  220.11 -  Thermography  220.12 -  Single Photon Emission Computed Tomograph (SPECT)  220.13 -  Percutaneous Image- Guided Breast Biopsy 230 -  Renal and Genitourinary System -  ESRD Services  230.1 -  Treatment of Kidney Stones  230.2 -  Uroflowmetric Evaluations  230.3 -  Sterilization  230.4 -  Diagnosis and Treatment of Impotence  230.5 -  Gravlee Jet Washer  230.6 -  Vabra Aspirator  230.7 -  Water Purification and Softening Systems Used in Conjunction With Home Dialysis  230.8 -  Non -Implantable Pelvic Floor  Electrical Stimulator  230.9 -  Cryosurgery of Prostate  230.10 -  Incontinence Control Devices  230.11 -  Diagnostic Pap Smears  (RETIRED)  230.12 -  Dimethyl Sulfoxide (DMSO)  230.13 -  Peridex CAPD Filter Set  230.14 -  Ultrafiltration Monitor  230.15 -  Electrical Continence Aid  230.16 -  Bladder Stimulators (Pacemakers)  230.17 -  Urinary Drainage Bags  230.18 -  Sacral Nerve Stimulation for Urinary Incontinence  230.19 -  Levocarnitine for Use in the Treatment of Carnitine Deficiency in ESRD Patients  240 -  Respiratory System  240.1 -  Lung Volume Reduction Surgery (Reduction Pneumoplasty) (Various Effective Dates Below)  240.2 -  Home Use of Oxygen  240.2.1 -  Home Use of Oxygen in Approved Clinical Trials (Effective March 20, 2006)  240.2.2  Home Oxygen Use to Treat Cluster Headache (CH) (Effective January 4, 2011)  (RETIRED)  240.3 -  Heat Treatment, Including the Use of Diathermy and Ultra -Sound for Pulmonary Conditions  240.4 -  Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (Effective March 13, 2008)  240.4.1 -  Sleep Testing for Obstructive Sleep Apnea (OSA) (Effective March 3, 2009)  240.5 -  Intrapulmonary Percussive Ventilator (IPV)  240.6 -  Transvenous (Catheter) Pulmonary Embolectomy (RETIRED)  240.7 -
(Medicare National Coverage Determinations Manual)
(Effective March 3, 2009)  240.5 -  Intrapulmonary Percussive Ventilator (IPV)  240.6 -  Transvenous (Catheter) Pulmonary Embolectomy (RETIRED)  240.7 -  Postural Drainage Procedures and Pulmonary Exercises  240.8 -  Pulmonary Rehabilitation Services  250 -  Skin 250.1 -  Treatment of Psoriasis  250.2 -  Hemorheograph  250.3 -  Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases  250.4 -  Treatment of Actinic Keratosis  250.5 -  Dermal Injections for the Treatment of Facila Lipodystrophy Syndrome (LDS)  260 -  Transplantation -  Solid Organ Transplants  260.1 -  Adult Liver Transplantation  260.2 -  Pediatric Liver Transplantation  260.3 -  Pancreas Transplants (Effective April 26, 2006)  260.3.1  Islet Cell Transplantation in the Context of a Clinical Trial  260.4 -  Reserved  260.5 -  Intestinal and Multi- Visceral Transplantation (Effective May 11, 2006)  260.6 -  Dental Examination Prior to Kidney Transplantation 260.7 -  Lymphocyte Immune Globulin, Anti -Thymocyte Globulin (Equine)  260.8 -  Reserved  260.9 -  Heart Transplants  260.10 -  Heartsbreath Test for Heart Transplant Rejection (Effective December 8, 2008)  270 -  Wound Treatment  270.1 -  Electrical Stimulation (ES) and Electromagnetic Therapy for the Treatment of Wounds  (Effective July 1, 2004)  270.2 -  Noncontact Normothermic Wound Therapy (NNWT)  270.3 -  Blood- Derived Products for Chronic Non- Healing Wounds  (Various Effective Dates Below)  270.4 -  Treatment of Decubitus Ulcers  270.5 -  Porcine Skin and Gradient Pressure Dressings  270.6 -  Infrared Therapy Devices (Effective October 24, 2006)  280 -  Medical and Surgical Supplies  280.1 -  Durable Medical Equipment Reference List (Effective May 5, 2005)  280.2 -  White Cane for Use by a Blind Person  280.3 -  Mobility Assistive Equipment (MAE) (Effective May 5, 2005)  280.4 -  Seat Lift  280.6 -  Pneumatic Compression Devices  280.7 -  Hospital Beds  280.8 -  Air-Fluidized Bed 280.10 -
(Medicare National Coverage Determinations Manual)
-  Mobility Assistive Equipment (MAE) (Effective May 5, 2005)  280.4 -  Seat Lift  280.6 -  Pneumatic Compression Devices  280.7 -  Hospital Beds  280.8 -  Air-Fluidized Bed 280.10 -  Prosthetic Shoe  280.11 -  Corset Used as Hernia Support  280.12 -  Sykes Hernia Control  280.13 -  Transcutaneous Electrical Nerve Stimulators (TENS)  (RETIRED)  280.14  Infusion Pumps  280.15 -  INDEPENDENCE iBOT 4000 Mobility System (Effective July 27, 2006)  280.16 Seat Elevation Equipment (Power Operated) on Power Wheelchairs
(Medicare National Coverage Determinations Manual)
(Effective May 16, 2023)  290 -  Nursing Services  290.1 -  Home Health Visits to a Blind Diabetic  290.2 -  Home Health Nurses Visits to Patients Requiring Heparin Injections  300 -  Diagnostic Tests Not Otherwise Classified  300.1 -  Obsolete or Unreliable Diagnostic Tests  310 -  Clinical Trials  310.1 -  Routine Costs in Clinical Trials  (Effective July 9, 2007)   200 - Pharmacology (Rev. 1, 10- 03-03)  No coverage determinations   200.1 - Nesiritide for Treatment of Heart Failure Patients (Effective March 2, 2006)  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A. General  Nesiritide (Natrecor) is Food and Drug Administration (FDA) -approved for the intravenous treatment of patients with acutely decompensated congestive heart failure (CHF) who have dyspnea (shortness of breath) at rest or with minimal activity.  Nesiritide is not self -administered.   B. Nationally Covered Indications   N/A  C. Nationally Non -Covered Indications   Effective for dates of service on or after March 2, 2006, the Centers for Medicare & Medicaid Services has determined that there is sufficient evidence to conclude that the use of Nesiritide for the treatment of CHF is not reasonable and necessary for Medi care beneficiaries in any setting.   D. Other   Effective for dates of service on or after March 2, 2006, this determination applies only to the treatment of CHF and does not change Medicare Administrative Contractor (MAC) discretion to cover other off -label uses of Nesiritide or use consistent with the  current FDA indication for intravenous treatment of patients with acutely decompensated CHF who have dyspnea at rest or with minimal activity.   200.2 - Nebulized Beta Adrenergic Agonist Therapy for Lung Diseases  (Effective September 10, 2007)  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A. General
(Medicare National Coverage Determinations Manual)
A. General   Lung diseases such as chronic obstructive pulmonary disease (COPD) and asthma are characterized by airflow limitation that may be partially or completely reversible.  Pharmacologic treatment with bronchodilators is used to prevent and/or control daily symptoms that may cause disability for persons with these diseases.  These medications  are intended to improve the movement of air into and from the lungs by relaxing and dilating the bronchial passageways.  Beta adrenergic agonists are a commonly prescribed class of bronchodilator drug.  They can be administered via nebulizer, metered dose inhaler, orally, or dry powdered inhaler.   Nebulized beta adrenergic agonist with racemic albuterol has been used for many years.  More recently, levalbuterol, the (R) enantiomer of racemic albuterol, has been used in some patient populations.  There are concerns regarding the appropriate use of ne bulized beta adrenergic agonist therapy for lung disease.   B. Nationally Covered Indications   N/A  C. Nationally Non -Covered Indications   N/A  D. Other   After examining the available medical evidence, the Centers for Medicare & Medicaid Services determines that no national coverage determination is appropriate at this time.  Section 1862(a)(1)(A) of the Social Security Act decisions should be made by local  MACs through a local coverage determination process or case- by-case adjudication.  See Heckler v. Ringer , 466 U.S. 602, 617 (1984) (Recognizing that the Secretary has discretion to either establish a generally applicable rule or to allow individual adjudi cation.).  See also, 68 Fed. Reg. 63692, 63693 (November 7, 2003).  200.3 - Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease (AD)  (Rev.: 11692, Issued:11- 09-22, Effective: 04 -07-22, Implementation: 12- 12-22)  A. General
(Medicare National Coverage Determinations Manual)
A. General   Alzheimers disease (AD) is a currently irreversible brain disorder that progressively degrades memory, cognitive function, and ability to carry out tasks of daily living. AD is the number one cause of dementia in older Americans.   Antiamyloid -beta monoclonal antibodies (antiamyloid mAbs) are laboratory- made proteins designed to bind a specific substance in the body, with the goal of marking it for destruction by the bodys immune system.  Scientists design various mAbs as treatments  with the goal of targeting and neutralizing or clearing infections (like the COVID -19 virus), cancer cells, and in the case of AD, amyloid accumulation in the brain.   B. Nationally Covered Indications   Effective April 7, 2022, the Centers for Medicare & Medicaid Services (CMS) covers Food and Drug Administration (FDA) approved monoclonal antibodies directed against amyloid for the treatment of AD when furnished in accordance with Section B under coverage with evidence development (CED) for patients who have a clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia, both with confirmed presence of amyloid beta pathology consistent with AD.   Coverage Criteria:   1)    Monoclonal antibodies directed against amyloid that are approved by the FDA for the treatment of AD based upon evidence of efficacy from a change in a surrogate endpoint (e.g., amyloid reduction) considered as reasonably likely to predict clinical be nefit may be covered in a randomized controlled trial conducted under an investigational new drug (IND) application.   2)    Monoclonal antibodies directed against amyloid that are approved by the FDA for the treatment of AD based upon evidence of efficacy from a direct measure of clinical benefit may be covered in CMS -approved prospective comparative studies.  Study data for CMS -approved prospective comparative studies may be collected in a registry.
(Medicare National Coverage Determinations Manual)
3)    For CMS -approved studies, the protocol, including the analysis plan, must include:  a. A study population whose diversity of patients are representative of the national population with MCI due to AD or mild AD dementia. b. A neurocognitive evaluation and a description of the instruments used to assess cognition and function for the clinical diagnosis of MCI due to AD or mild AD dementia for study enrollment and outcomes assessment. c. A description of:  i. The multidisciplinary dementia team and optimal medical management.  ii. Study sites with clinical expertise and infrastructure to provide treatments consistent with the safety monitoring outlined in the FDA -approved label.  4)    CMS -approved studies of a monoclonal antibody directed against amyloid (antiamyloid mAb) approved by the FDA for the treatment of AD based upon evidence of efficacy from a direct measure of clinical benefit must address all of the questions below:  a. Does the antiamyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?
(Medicare National Coverage Determinations Manual)
b. Do benefits, and harms such as brain hemorrhage and edema, associated with use of the antiamyloid mAb, depend on characteristics of patients, treating clinicians, and settings?  c. How do the benefits and harms change over time?  5)   CMS -approved studies must adhere to the following standards of scientific integrity that have been identified by the Agency for Healthcare Research and Quality (AHRQ):  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 (NCD).  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 FDA, it is also in compliance with 21 C FR 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 pati ent 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 Regis tries (RoPR).  k. The research study protocol specifies the method and timing
(Medicare National Coverage Determinations Manual)
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 Regis tries (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 accessible 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.  The principal investigator must submit the complete trial protocol, cite where the detailed analysis plan for the CMS CED questions occurs in the protocol, and provide a statement addressing how the study satisfies each of the standards of scientific integ rity (a. through m. listed above), as well as the investigators contact information, to the email address below.  The information will be reviewed, and approved trials will be identified on the CMS Website.
(Medicare National Coverage Determinations Manual)
The Email address for protocol submissions is:  clinicalstudynotification@cms.hhs.gov. The Email subject line should be: "CED Monoclonal Antibodies for the Treatment of Alzheimers Disease [name of sponsor/primary investigator]"   Monoclonal antibodies directed against amyloid indicated for the treatment of AD are  covered when furnished according to the FDA  approved indication in National Institutes of  Health (NIH) -supported trials.  For any CMS -approved study, or NIH -supported trial, that includes a beta amyloid positron emission tomography (PET) scan as part of the protocol, it has been determined that these trials or studies also meet the CED requirements included in the Beta Amyloid PET in Dementia and Neurodegenerative Disease NCD (220.6.20).   C.     Nationally Non -Covered Indications   Monoclonal antibodies directed against amyloid for the treatment of AD provided outside of an FDA -approved randomized controlled trial, CMS -approved studies, or studies supported by the NIH, are nationally non- covered.   D.   Other   N/A.   (This NCD last reviewed April 2022.)   210 - Prevention  (Rev. 1, 10- 03-03)  210.1 - Prostate Cancer Screening Tests  (Rev. 48, Issued:  03- 17-06; Effective/Implementation Dates:  06 -19-06) CIM 50 -55  Covered   A. General   Section 4103 of the Balanced Budget Act of 1997 provides for coverage of certain prostate cancer screening tests subject to certain coverage, frequency, and payment limitations.  Medicare will cover prostate cancer screening tests/procedures for the early detection of prostate cancer.  Coverage of prostate cancer screening tests includes the following procedures furnished to an individual for the early detection of prostate cancer:    Screening digital rectal examination; and   Screening prostate specific antigen blood test.  B. Screening Digital Rectal Examinations
(Medicare National Coverage Determinations Manual)
B. Screening Digital Rectal Examinations   Screening digital rectal examinations are covered at a frequency of once every 12 months for men who have attained age 50 (at least 11 months have passed following the month in which the last Medicare -covered screening digital rectal examination was perfor med).  Screening digital rectal examination means a clinical examination of an individuals prostate for nodules or other abnormalities of the prostate.  This screening must be performed by a doctor of medicine or osteopathy (as defined in 1861(r)(1)  of the Act), or by a physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse midwife (as defined in 1861(aa) and 1861(gg)  of the Act) who is authorized under State law to perform the examination, fully knowledgeable about the beneficiarys medical condition, and would be responsible for using the results of any examination performed in the overall management of the beneficiarys specific medical problem.   C. Screening Prostate Specific Antigen Tests   Screening prostate specific antigen tests are covered at a frequency of once every 12 months for men who have attained age 50 (at least 11 months have passed following the month in which the last Medicare -covered screening prostate specific antigen test was performed).  Screening prostate specific antigen tests (PSA) means a test to detect the marker for adenocarcinoma of prostate.  PSA is a reliable immunocytochemical marker for primary and metastatic adenocarcinoma of prostate.  This screening must be ordered by the beneficiarys physician or by the beneficiarys physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse midwife (the term attending physician is defined in 1861(r)(1)  of the Act to mean a doctor of medicine or osteopathy and the terms physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse midwife are defined in 1861(aa) and 1861(gg)  of the Act) who is fully knowledgeable about the beneficiarys medical condition, and who would be responsible for using the results of any examination (test) performed in the overall management of the beneficiarys specific medical problem.
(Medicare National Coverage Determinations Manual)
210.2 - Screening Pap Smears and Pelvic Examinations for Early Detection of Cervical or Vaginal Cancer  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  Screening Pap Smear  A screening pap smear and related medically necessary services provided to a woman for the early detection of cervical cancer (including collection of the sample of cells and a physicians interpretation of the test results) and pelvic examination (including clinical breast examination) are covered under Medicare Part B when ordered by a physician (or authorized practitioner) under one of the following conditions:    She has not had such a test during the preceding two years or is a woman of childbearing age ( 1861(nn )) of the Social Security Act (the Act).    There is evidence (on the basis of her medical history or other findings) that she is at high risk of developing cervical cancer and her physician (or authorized practitioner) recommends that she have the test performed more frequently than every two years .  High risk factors for cervical and vaginal cancer are:    Early onset of sexual activity (under 16 years of age)    Multiple sexual partners (five or more in a lifetime)    History of sexually transmitted disease (including HIV infection)    Fewer than three negative or any pap smears within the previous seven years; and   DES (diethylstilbestrol) -  exposed daughters of women who took DES during pregnancy.   NOTE:  Claims for pap smears must indicate the beneficiarys low or high risk status by including the appropriate diagnosis code on the line item (Item 24E of the Form CMS -1500).  Definitions    A woman as described in 1861(nn)  of the Act is a woman who is of childbearing age and has had a pap smear test during any of the preceding 3 years that indicated the presence of cervical or vaginal cancer or other abnormality, or is at high risk of developing cervical or vaginal cancer.    A woman of childbearing age is one who is premenopausal and has been determined by a physician or other qualified practitioner to be of childbearing age, based upon the medical history or other findings.