evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
ii. Evaluation of Thoracic Aortic Dissection and Aneurysm   Studies have shown that MRA of the chest has a high level of diagnostic accuracy for pre-operative and post -operative evaluation of aortic dissection of aneurysm.  Depending on the clinical presentation, MRA may be used as an alternative to other non- invasive imaging technologies, such as transesophageal echocardiography and CT.  Generally, Medicare will provide coverage only for MRA or for CA when used as a diagnostic test.  However, if both MRA and CA of the chest are used, the physician must demonstrate the medical need for performing these tests.  While the intent of this policy is to provide reimbursement for either RA or CA, the Centers for Medicare & Medicaid Services (CMS) is also allowing flexibility for physicians to make appropriate decisions concerning the use of these tests based on the needs of individual patients.  CMS anticipates, however, low utilization of the combined use of MRA and CA.  As a result, CMS encourages the Medicare Administrative Contractors (MACs) to monitor the use of these tests and, where indicated, require evidence of  the need to perform both MRA and CA.  C. Contraindications and Nationally Non -Covered Indications   1. Contraindications   The MRI is not covered when the following patient -specific contraindications are present:   MRI is not covered for patients with cardiac pacemakers or with metallic clips on vascular aneurysms unless the Medicare beneficiary meets the provisions of the following exceptions:   Effective July 7, 2011, the contraindications will not apply to pacemakers when used according to the FDA -approved labeling in an MRI environment, or
(Medicare National Coverage Determinations Manual)
Effective July 7, 2011, the contraindications will not apply to pacemakers when used according to the FDA -approved labeling in an MRI environment, or   Effective February 24, 2011, CMS believes that the evidence is promising although not yet convincing that MRI will improve patient health outcomes if certain safeguards are in place to ensure that the exposure of the device to an MRI environment adversely affects neither the interpretation of the MRI result nor the proper functioning of the implanted device itself.  We believe that specific precautions (as listed below) could maximize benefits of MRI exposure for beneficiaries enrolled in clinical trials de signed to assess the utility and safety of MRI exposure.  Therefore, CMS determines that MRI will be covered by Medicare when provided in a clinical study under section 1862(a)(1)(E) (consistent with section 1142 of the Social Security Act (the Act)) throu gh the Coverage with Study Participation (CSP) form of Coverage with Evidence Development (CED) if the study meets the criteria in each of the three paragraphs below:   The approved prospective clinical study of MRI must, with appropriate methodology, address one or more aspects of the following questions:   1. Do results of MRI in implanted permanent pacemaker (PM)/implantable cardioverter defibrillator (ICD) beneficiaries with implanted cardiac devices affect physician decision making related to:   a. Clinical management strategy (e.g., in oncology, toward palliative or curative care)?  b. Planning of treatment interventions?; or  c. Prevention of unneeded diagnostic studies or interventions, or preventable exposures?   2. Do results of MRI in PM/ICD beneficiaries with implanted cardiac devices affect patient outcomes related to:   a. Survival?  b. Quality of life?; or  c. Adverse events during and after MR scanning?   In addition, the prospective clinical study of MRI must include safety criteria for all participants.  Such required safety measures for such studies, as further explained in guidance documents from professional societies must include, but are not limited to:  1. MRI should be done on a case -by-case and site- by-site basis.   2. MRI scan sequences, field intensity, and field(s) of exposure should be selected to minimize risk to the patient while gaining needed diagnostic information for diagnosis or for managing therapy.
(Medicare National Coverage Determinations Manual)
2. MRI scan sequences, field intensity, and field(s) of exposure should be selected to minimize risk to the patient while gaining needed diagnostic information for diagnosis or for managing therapy.   3. MRI scanning should be done only if the site is staffed with individuals with the appropriate radiology and cardiology knowledge and expertise on hand.  4. Implanted device patients who are candidates for recruitment for an MRI clinical study should be advised that life -threatening arrhythmias might occur during MRI and serious device malfunction might occur, requiring replacement of the device.   5. Radiology and cardiology personnel and a fully stocked crash cart should be readily available throughout the procedure in case a significant arrhythmia develops during the examination that does not terminate with the cessation of the MRI study.  The cardiologist should be familiar with the patients arrhythmia history and the implanted device.  A programmer that can be used to adjust the device as necessary should be readily available.   6. All such patients should be actively monitored for cardiac and respiratory function throughout the examination.  At a minimum, ECG and pulse oximetry should be used. Visual and verbal contact with the patient must be maintained throughout the MRI scan.  The patient should be instructed to alert the MRI staff on hand to any unusual sensations, pains, or to any problems.  7. At the conclusion of the examination, the cardiologist should examine the device to confirm that the function is consistent with its pre -examination state.   8. Follow -up should include a check of the patients device at a time remote (1 -6 weeks) after the scan to confirm appropriate function.   9. If the implanted device manufacturer has indicated additional safety precautions appropriate for safe MRI performance, these must be included in the study protocol.  The clinical 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 question being asked in the study.  e. The research study is sponsored by an organization or individual capable of executing the proposed study successfully.
(Medicare National Coverage Determinations Manual)
d. The research study design is appropriate to answer the research question 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 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 integrity (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 www.ClinicalTrials.gov  website by the principal sponsor/investigator prior to the enrollment of the first study subject.   k. The research study protocol specifies the method and timing of public release of all pre -specified 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 mont hs 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 ).  However, a full report of the outcomes must be made public no later than three (3) years after the end of data collection.  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 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.
(Medicare National Coverage Determinations Manual)
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 neces sary for populations eligible for Medicare due to age, disability, or Medicaid eligibility.   Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality supports clinical research studies that CMS determines meet the above -listed standards and address the above -listed research questions.    MRI during a viable pregnancy is also contraindicated at this time.   The danger inherent in bringing ferromagnetic materials within range of MRI units generally constrains the use of MRI on acutely ill patients requiring life support systems and monitoring devices that employ ferromagnetic materials.    In addition, the long imaging time and the enclosed position of the patient may result in claustrophobia, making patients who have a history of claustrophobia unsuitable candidates for MRI procedures.   2. Nationally Non -Covered Indications   CMS has determined that MRI of cortical bone and calcifications, and procedures involving spatial resolution of bone and calcifications, are not considered reasonable and necessary indications within the meaning of section 1862(a)(1)(A) of the Act, and are  therefore non-covered.   D. Other  Effective June 3, 2010, all other uses of MRI or MRA for which CMS has not specifically indicated coverage or non- coverage continue to be eligible for coverage through individual MAC discretion.  220.2.1 - Magnetic Resonance Spectroscopy  (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Effective January  1, 2021, the Centers  for Medicare & Medicaid  Services  determined  that no national coverage determination (NCD) is appropriate at this time for Magnetic Resonance Spectroscopy. 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.   220.3 - Magnetic Resonance Angiography (RETIRED)   (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Please note section 220.3 has been removed from the NCD Manual and merged with section 220.2 effective June 3, 2010.
(Medicare National Coverage Determinations Manual)
Please note section 220.3 has been removed from the NCD Manual and merged with section 220.2 effective June 3, 2010.   220.4 - Mammograms  (Rev. 1, 10- 03-03) CIM 50 -21  A diagnostic mammography is a radiologic procedure furnished to a man or woman with signs and symptoms of breast disease, or a personal history of breast cancer, or a personal history of biopsy  proven benign breast disease, and includes a physicians int erpretation of the results of the procedure.   A diagnostic mammography is a covered service if it is ordered by a doctor of medicine or osteopathy as defined in 1861 (r) (1)  of the Act.  A screening mammography is a radiologic procedure furnished to a woman without signs or symptoms of breast disease, for the purpose of early detection of breast cancer, and includes a physicians interpretation of the results of the procedure.  A screening mammography has limitations as it must be, at a minimum a two -view exposure (cranio- caudal and a medial lateral oblique view) of each breast.  Payment may not be made for a screening mammography performed on a woman under age 35.  Payment may be made for only one screening mammography performed on a woman over age 34, but under age 40.  For an asymptomatic woman over age 39, payment may be made for a screening mammography performed after at least 11 months have passed following the month in which the last screening mammography was performed.   A radiological mammogram is a covered diagnostic test under the following conditions:    A patient has distinct signs and symptoms for which a mammogram is indicated;    A patient has a history of breast cancer; or    A patient is asymptomatic but, on the basis of the patients history and other factors the physician considers significant, the physicians judgment is that a mammogram is appropriate.   Use of mammograms in routine screening of: (1) asymptomatic women aged 50 and over, and (2) asymptomatic women aged 40 or over whose mothers or sisters have had the disease, is considered medically appropriate, but would not be covered for Medicare purpose s.  Cross -reference:
(Medicare National Coverage Determinations Manual)
Cross -reference:   The Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 80.   The Medicare Benefit Policy Manual, Chapter 1, Inpatient Hospital Services, 50     220.5 - Ultrasound Diagnostic Procedures (Effective May 22, 2007)  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A. General   Ultrasound diagnostic procedures utilizing low energy sound waves are being widely employed to determine the composition and contours of nearly all body tissues except bone and air -filled spaces.  This technique permits noninvasive visualization of even the deepest structures in the body.  The use of the ultrasound technique is sufficiently developed that it can be considered essential to good patient care  in diagnosing a wide variety of conditions.   Ultrasound diagnostic procedures are listed below and are divided into two categories. Medicare coverage is extended to the procedures listed in Category I.  Periodic claims review by A/B MAC (A) medical consultants should be conducted to ensure that the t echniques are medically appropriate and the general indications specified in these categories are met.  Techniques in Category II are considered experimental and should not be covered at this time.  B. Nationally Covered Indications   Category I - (Clinically effective, usually part of initial patient evaluation, may be an adjunct to radiologic and nuclear medicine diagnostic technique)
(Medicare National Coverage Determinations Manual)
 Echoencephalography, (Diencephalic Midline) (A -Mode)   Echoencephalography, Complete (Diencephalic Midline and Ventricular Size)   Ocular and Orbital Echography (A -Mode)   Covered procedures include efforts to determine the suitability of aphakic patients for implantation of an artificial lens (pseudophakoi) following cataract surgery.   Ocular and Orbital Sonography (B -Mode)   Echocardiography, Pericardial Effusion (M -Mode)   Pericardiocentesis, by Ultrasonic Guidance   Echocardiography, Cardiac Valve(s) (M -Mode)   Echocardiography, Complete (M -Mode)   Echocardiography, limited (e.g., follow -up or limited study) (M -Mode)   Pleural Effusion Echography  Thoracentesis, by Ultrasonic Guidance   Abdominal Sonography, complete survey study (B -Scan)   Abdominal Sonography, limited (e.g., follow -up or limited study) (B -Scan)   Abdominal Sonography is not synonymous with ultrasound examination of individual organs.   Renal Cyst Aspiration, by Ultrasonic Guidance   Renal Biopsy, by Ultrasonic Guidance   Pancreas Sonography (B -Scan)   Pancreatic Sonography has proven effective in diagnosing pseudocysts.  Spleen Sonography (B -Scan)   Abdominal Aorta Echography (A -Mode)   Abdominal Aorta Sonography (B -Scan)   Retroperitoneal Sonography (B -Scan)   Retroperitoneal Sonography does not include planning of fields for radiation therapy.   Urinary Bladder Sonography (B -Scan)   Urinary bladder Sonography does not include staging of bladder tumors.   Pregnancy Diagnosis Sonography (B -Scan)   Fetal Age Determination (Biparietal Diameter) Sonography (B -Scan)   Fetal Growth Rate Sonography (B -Scan)   Placenta Localization Sonography (B -Scan)   Pregnancy Sonography, Complete (B -Scan)   Molar Pregnancy Diagnosis Sonography (B -Scan)   Ectopic Pregnancy Diagnosis Sonography (B -Scan)   Passive Testing (Antepartum Monitoring of Fetal Heart Rate In the Resting Fetus)   Intrauterine Contraceptive Device Sonography
(Medicare National Coverage Determinations Manual)
Pregnancy Diagnosis Sonography (B -Scan)   Ectopic Pregnancy Diagnosis Sonography (B -Scan)   Passive Testing (Antepartum Monitoring of Fetal Heart Rate In the Resting Fetus)   Intrauterine Contraceptive Device Sonography (B -Scan)   Pelvic Mass Diagnosis Sonography (B -Scan)   Amniocentesis, by Ultrasonic Guidance   Arterial Flow Study, Peripheral (Doppler)   Venous Flow Study, Peripheral (Doppler)   Arterial Aneurysm, Peripheral (B -Scan)   Radiation Therapy Planning Sonography (B -Scan)   Thyroid Echography (A -Mode)   Thyroid Sonography (B -Scan)   Breast Echography (A -Mode)   Breast Sonography (B -Scan)   Hepatic Sonography (B -Scan)   Gallbladder Sonography   Renal Sonography   Two-Dimensional Echocardiography (B -Mode)    Monitoring of cardiac output (Esophageal Doppler) for ventilated patients in the ICU and operative patients with a need for intra -operative fluid optimization
(Medicare National Coverage Determinations Manual)
C. Nationally Non -Covered Indications   Category II - (Clinical reliability and efficacy not proven)    B-Scan for atherosclerotic narrowing of peripheral arteries.   D. Other  Uses for ultrasound diagnostic procedures not listed in Category I or II above are left to local MAC discretion.  In view of the rapid changes in the field of ultrasound diagnosis, uses for ultrasound diagnostic procedures other than those listed under Cat egories I and II should be carefully reviewed before payment.  Medical justification may be required.   Cross reference: 20.17   220.6 - Positron Emission Tomography (PET) Scans (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Effective January 1, 2022, the Centers for Medicare & Medicaid Services removed the  umbrella national coverage determination (NCD) for Positron Emission Tomography (PET) Scans. In the absence of an NCD, coverage determinations for all oncologic and non-oncologic uses of PET that are not included in another NCD under section 220.6 will be made by the Medicare Administrative Contractors under section 1862(a)(1)(A) of the Social Security Act. All PET indications currently covered or non- covered under NCDs under section 220.6 remain unchanged and MACs shall not alter coverage for indications covered under NCDs.   220.6.1 - PET for Perfusion of the Heart (Various Effective Dates)  (Rev. 120; Issued:  05- 06-10; Effective Date:  04 -03-09; Implementation Date:  10- 30-09)  1.  Rubidium 82 (Effective March 14, 1995)   Effective for services performed on or after March 14, 1995, PET scans performed at rest or with pharmacological stress used for noninvasive imaging of the perfusion of the heart for the diagnosis and management of patients with known or suspected coronary artery disease using the FDA -approved radiopharmaceutical Rubidium 82 (Rb 82) are covered, provi ded the requirements below are met:   o The PET scan, whether at rest alone, or rest with stress, is performed in place of, but not in addition to, a single photon emission computed tomography (SPECT); or
(Medicare National Coverage Determinations Manual)
o The PET scan, whether at rest alone, or rest with stress, is performed in place of, but not in addition to, a single photon emission computed tomography (SPECT); or   o The PET scan, whether at rest alone or rest with stress, is used following a SPECT that was found to be inconclusive. In these cases, the PET scan must have been considered necessary in order to determine what medical or surgical intervention is required t o treat the patient. (For purposes of this requirement, an inconclusive test is a test(s) whose results are equivocal, technically uninterpretable, or discordant with a patient's other clinical data and must be documented in the beneficiary's file.)   o For any PET scan for which Medicare payment is claimed for dates of services prior to July 1, 2001, the claimant must submit additional specified information on the claim form (including proper codes and/or modifiers), to indicate the results of the PET sc an. The claimant must also include information on whether the PET scan was performed after an inconclusive non- invasive cardiac test. The information submitted with respect to the previous noninvasive cardiac test must specify the type of test performed pr ior to the PET scan and whether it was inconclusive or unsatisfactory. These explanations are in the form of special G codes used for billing PET scans using Rb 82. Beginning July 1, 2001, claims should be submitted with the appropriate codes.   2. Ammonia N -13 (Effective October 1, 2003)   Effective for services performed on or after October 1, 2003, PET scans performed at rest or with pharmacological stress used for noninvasive imaging of the perfusion of the heart for the diagnosis and management of patients with known or suspected coronary artery disea se using the FDA -approved radiopharmaceutical ammonia N -13 are covered, provided the requirements below are met:   o The PET scan, whether at rest alone, or rest with stress, is performed in place of, but not in addition to, a SPECT; or