(Medicare National Coverage Determinations Manual)

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.   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.   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:   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)    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 (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   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: