(Medicare National Coverage Determinations Manual)

FDG PET for Cancers  Tumor Type  Initial Treatment Strategy  (formerly diagnosis & staging  Subsequent Treatment Strategy (formerly restaging & monitoring response to treatment  Colorectal  Cover  Cover  Esophagus  Cover  Cover  Head and Neck (not thyroid, CNS)  Cover  Cover  Lymphoma  Cover  Cover  Non-small cell lung  Cover  Cover  Ovary  Cover  Cover  Brain  Cover  Cover  Cervix  Cover with exceptions *  Cover  Small cell lung  Cover  Cover  Soft tissue sarcoma  Cover  Cover  Pancreas  Cover  Cover  Testes  Cover  Cover  Prostate  Non-cover  Cover  Thyroid  Cover  Cover  Breast (male and female)  Cover with exceptions *  Cover  Melanoma  Cover with exceptions *  Cover  All other solid tumors  Cover  Cover  Myeloma  Cover  Cover  All other cancers not listed  Cover  Cover   *Cervix:  Nationally  non-covered for the initia l diagnosis of  cervical cancer related to initia l anti-tumor t reatme nt strategy.  All o ther indications for initia l anti- tumor t reatme nt strategy for cer vical cancer are nationally  covered.   *Breast:  N ationally  non- covered for initia l diagnosis and/or  staging of axillary lymph nod es. Nationally  covered f or initial staging of metastatic disease.  All oth er indications f or initia l anti-tumor t reatme nt strategy for br east cancer a re nationally  covered.   *Melanoma:  Nationally  non-covered for initia l staging of regional lymph node s.  All oth er indications f or initia l anti -tumor t reatment strategy for m elanoma ar e nationally  covered.  D. Other   N/A  220.6.19  Positron Emission Tomography NaF- 18 (NaF- 18 PET) to Identify Bone Metastasis of Cancer (Effective February 26, 2010)  (Rev. 11158, Issued: 12- 16-21, Effective:12 -15-2017, Implementation: 01- 27-22)  A. General   Positron Emission Tomography (PET) is a minimally -invasive, diagnostic imaging procedure that assesses the level of metabolic activity and perfusion in various organ systems of the body. A positron camera (tomograph) is used to produce cross -sectional tomo graphic images, which are obtained from positron- emitting radioactive tracer substances (radiopharmaceuticals) such as F -18 sodium fluoride (NaF -18).   B. Nationally Covered  Indications   The confirmatory analyses were not published during the 24- month time period. Therefore, effective December 15, 2017, CMS determines that there are no nationally covered indications for PET NaF -18.  C. Nationally Non -Covered  Indications   Effective December 15, 2017, CMS determines that PET NaF -18 PET is nationally non-covered.   D. Other  Other PET radiopharmaceutical tracers for cancer can be covered at local Medicare Administrative Contractor discretion when used according to their FDA -approved indication(s).   (This NCD last reviewed  December 2017.)    220.6.20 - Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease  (RETIRED)  (Rev. 12364; Issued:11- 16-23; Effective:10 -13-23; Implementation:12 -19-23)  Effective October 13, 2023, CMS removed NCD 220.6.20, ending CED for PET beta amyloid imaging and permitting Medicare coverage determinations for PET beta amyloid imaging to be made by the Medicare Administrative Contractors under section 1862(a)(1)(A) of the Social Security Act.   220.7 - Xenon Scan (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Effective December  18, 2014, NCD 220.7 is  retired.     220.8- Nuclear Radiology Procedure (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)     Effective December  18, 2014, NCD 220.8 is  retired.   220.9 - Digital Subtraction Angiography (DSA)  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  Digital subtraction angiography (DSA) is a diagnostic imaging technique that applies computer technology to fluoroscopy for the purpose of visualizing the same vascular structures observable with conventional angiography.  Since the radiographic contrast m aterial can be injected into a vein rather than an artery, the procedure reduces the risk to patients, and can be done on an outpatient basis.  A/B MACs (A) and (B) should be alert to possible increases in utilization of DSA over conventional angiographic procedures, as well as to the fact that ordinarily patients should not require inpatient hospitalization solely to perform the procedure.   Payment for DSA should not exceed, and may be less than, that being paid for conventional angiographic techniques.   220.10 - Portable Hand -Held X -Ray Instrument  (Rev. 1, 10- 03-03) CIM 50 -48  This low intensity x -ray imaging device is a light weight  portable hand -held instrument using a low level isotope as its penetrating energy source.  It can picture any part of the human anatomy that can be inserted in the space between the energy source and the viewing mechanism.  The device can be useful in making an immediate diagnosis in the following settings: isolated areas, accident scenes, sports events and emergency rooms.  It is also useful in the following instances where fluoroscopy would ordinarily be used:  localization of foreign bodies, selected surgical procedures and the evaluation of premature or low birth weight infants.  The use of the portable hand- held x- ray instrument as an imaging device is covered under Medicare.  It should be reimbursed as part of the physicians professional service, and no additional charge should be allowed.   220.11 - Thermography (Rev. 1, 10- 03-03) CIM 50 -5  Thermography is the measurement of self -emanating infrared radiation that reveals temperature variations at the surface of the body.  The thermographic device senses body temperature and demonstrates areas of differing heat emission by producing brightly c olored patterns.  Each color represents a specific temperature level.  Interpretation of these color patterns according to designated anatomic distribution is thought to aid in diagnosing a vast array of diseases.   Thermography for any indication (including breast lesions which were excluded from Medicare coverage on July 20, 1984) is excluded from Medicare coverage because the available evidence does not support this test as a useful aid in the diagnosis or treatment of illness or injury.  Therefore, it is not considered effective.  This exclusion was published as a CMS Final Notice in the Federal Register on November 20, 1992.   220.12 - Single Photon Emission Computed Tomograph (SPECT)  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  The single photon emission computed tomograph (SPECT) acquires information on the concentration of radionuclides introduced into the patients body.  It is useful in the diagnosis of several clinical conditions including:    Stress fracture   Spondylosis   Infection (e.g., discitis)   Tumor (e.g., osteoid osteoma)   Analyze blood flow to an organ, as in the case of myocardial viability  Differentiate ischemic heart disease from dilated cardiomyopathy.   Frequency limitations:  A/B MAC (A)s or (B)s discretion.   In the case of myocardial viability, FDG positron emission tomography (PET) may be used following a SPECT that was found to be inconclusive.  However, SPECT may not be used following an inconclusive FDG PET performed to evaluate myocardial viability.   220.13 - Percutaneous Image -Guided Breast Biopsy  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  Percutaneous image- guided breast biopsy is a method of obtaining a breast biopsy through a percutaneous incision by employing image guidance systems.  Image guidance systems may be either ultrasound or stereotactic.   The Breast Imaging Reporting and Data System (or BIRADS system) employed by the American College of Radiology provides a standardized lexicon with which radiologists may report their interpretation of a mammogram.  The BIRADS grading of mammograms is as follows: Grade I -Negative, Grade II -Benign finding, Grade III -Probably benign, Grade IV -Suspicious abnormality, and Grade V -Highly suggestive of malignant neoplasm.  A. Non -Palpable Breast Lesions   Effective January 1, 2003, Medicare covers percutaneous image -guided breast biopsy using stereotactic or ultrasound imaging for a radiographic abnormality that is non- palpable and is graded as a BIRADS III, IV, or V.   B. Palpable Breast Lesions   Effective January 1, 2003, Medicare covers percutaneous image guided breast biopsy using stereotactic or ultrasound imaging for palpable lesions that are difficult to biopsy using palpation alone.  A/B MACs (A) and (B) have the discretion to decide what types of palpable lesions are difficult to biopsy using palpation.  230 - Renal and Genitourinary System - ESRD Services   230.1 - Treatment of Kidney Stones  (Rev. 1, 10- 03-03) CIM 35 -81  Traditional approaches for the treatment of kidney stones are the surgical technique nephrectomy (or nephrotomy) and endoscopic treatments via the urethra.  In the last few years, several new approaches in the surgical management of upper urinary tract kidney stones have been developed, among them invasive and noninvasive lithotripsy techniques.  In addition to the traditional surgical/endoscopic techniques for the treatment of kidney stones, the following lithotripsy techniques are also covered for services rendered on or after March 15, 1985.  A.  Extracorporeal Shock Wave Lithotripsy  Extracorporeal Shock Wave Lithotripsy (ESWL) is a noninvasive method of treating kidney stones using a device called a lithotriptor.  The lithotriptor uses shock waves generated outside of the body to break up upper urinary tract stones.  It focuses the shock waves specifically on stones under x- ray visualization, pulverizing them by repeated shocks.  ESWL is covered under Medicare for use in the treatment of upper urinary tract kidney stones.   B.  Percutaneous Lithotrips y  Percutaneous lithotripsy (or nephrolithotomy) is an invasive method of treating kidney stones by using ultrasound, electrohydraulic or mechanical lithotripsy.  A probe is inserted through an incision in the skin directly over the kidney and applied to the stone. A form of lithotripsy is then used to fragment the stone.  Mechanical or electrohydraulic lithotripsy may be used as an alternative or adjunct to ultrasonic lithotripsy.  Percutaneous lithotripsy of kidney stones by ultrasound or by the related techniques of electrohydraulic or mechanical lithotripsy is covered under Medicare.   The following is covered for services rendered on or after January 16, 1988.  C.  Transurethral Ureteroscopic Lithotripsy   Transurethral ureteroscopic lithotripsy is a method of fragmenting and removing ureteral and renal stones through a cystoscope.  The cystoscope is inserted through the urethra into the bladder.  Catheters are passed through the scope into the opening where  the ureters enter the bladder.  Instruments passed through this opening into the ureters are used to manipulate and ultimately disintegrate stones, using either mechanical crushing, transcystoscopic electrohydraulic shock waves, ultrasound, or laser.  Tra nsurethral ureteroscopic lithotripsy for the treatment of urinary tract stones of the kidney or ureter is covered under Medicare.   230.2 - Uroflowmetric Evaluations  (Rev. 1, 10- 03-03) CIM 50 -33