Cardiovascular Nuclear Medicine

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Code of Federal Regulations:

42 CFR Section 410.32 indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements) who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician (or other qualified non-physician provider) who is treating the beneficiary are not reasonable and necessary (see Sec. 411.15(k)(1) of this chapter).

CMS Publications:

CMS Publication 100-04, Medicare Claims Processing, Chapter 12:

70: Payment conditions for radiology services

CMS Publication 100-04, Medicare Claims Processing, Chapter 13:

20: Payment conditions for radiology services

50: Payment for the supply of a radiopharmaceutical diagnostic imaging agent and/or pharmacologic stressing agent with diagnostic nuclear medicine procedures.

90: Services of portable X-Ray suppliers

Abstract:

Cardiovascular nuclear imaging employs non-invasive techniques to assess alterations in coronary artery flow, and ventricular function.

The specific imaging technique (perfusion versus ventricular function) and the reason for the imaging determine which radionuclide agent is employed. A myocardial perfusion study utilizes an imaging isotope agent that reflects segmental and global myocardial blood flow and uptake, the interpretation of which is used to make inference about the presence of scar and ischemia.

Ventricular function studies utilize specific imaging isotopes to outline the borders of the ventricular endocardium, or to identify the ventricular blood pool independent of the surrounding myocardium. The motion of the left ventricle, synchronized with the electrocardiogram, is used to generate wall motion and ejection fraction information.

These tests may be performed at rest and during exercise, or with pharmacologic intervention when exercise cannot be performed. The acquisition of the images may be planar (single plane) or by multiple planes with computer integration, SPECT (single-photon emission computer tomography).

Indications:
Cardiovascular nuclear imaging is indicated for the following:

Assessment of the functional and prognostic importance of angina;

Diagnostic evaluation of patients with chest pain and uninterpretable or equivocal ECG changes caused by drugs, bundle branch block, or left ventricular hypertrophy;

Risk assessment or re-evaluation of disease in patients who are asymptomatic or have stable symptoms, with known atherosclerotic heart disease on catheterization or SPECT perfusion imaging, who have not had a revascularization procedure within the past two years;

Detection of coronary artery disease in patients, without chest pain syndrome, with new-onset of diagnosed heart failure or left ventricular systolic dysfunction;

Evaluation of ischemic versus non-ischemic cardiomyopathy when cardiac catheterization / coronary angiography are not planned;

Evaluation of myocardial perfusion and/or function before and after coronary artery bypass surgery or other re-perfusion procedures;

Quantification and surveillance of myocardial infarction and prognostication in patients with infarction;

Assessment of congenital anomalies of coronary arteries;

Preoperative assessment for non-cardiac surgery, when used to determine risk for surgery and/or perioperative management in:

patients with minor or intermediate clinical risk predictors and poor functional capacity;

patients with intermediate or high likelihood of coronary heart disease, or patients with poor functional capacity undergoing high risk non-cardiac surgery;

The "ACA/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Non-Cardiac Surgery" (JACC 2007; 50:e159-e242) provides this information:

High risk surgery: aortic and peripheral vascular surgery

Intermediate risk surgery: intraperitoneal and intrathoracic surgery, carotid endarterectomy, head & neck surgery, orthopedic surgery, prostate surgery.

Low risk surgery: endoscopic procedures, superficial surgery, cataract surgery, breast surgery, ambulatory surgery

Poor functional capacity = less than 4 METS

Clinical risk factors:
1) history of ischemic heart disease

2) history of compensated or prior heart failure

3) history of cerebrovascular disease

4) diabetes mellitus

5) renal insufficiency

Decision-making for testing is based upon the presence of multiple clinical risk factors, the level of functional capacity, the risk of the surgery

and the likelihood that the results of the cardiac testing would change the management.Evaluation of ventricular function in patients with non-ischemic myocardial disease;

Evaluation of patients in whom an accurate measure of the ejection fraction is needed to make a determination of whether to implant a defibrillator or biventricular pacemaker;

Evaluation of a patient receiving chemotherapeutic drugs which are potentially cardiotoxic (e.g., adriamycin).

First pass studies will be considered medically necessary only when information sought is immediately relevant to the management of the patient’s clinical condition, and has not been previously obtained or likely to be obtained from other planned tests such as echocardiography or equilibrium gated blood pool studies. First pass studies may be indicated for the assessment and identification of shunts.

Infarct avid scintigraphy is indicated in patients in whom it is not possible to make a definitive diagnosis of myocardial infarction by EKG or enzyme testing.

Patient selection should be based on clinical grounds:

Patients with a high pretest probability of disease are not usually candidates for a study for diagnostic purposes, though the size and reversibility of a defect and its functional consequences may be required for clinical decision-making.

Patients with a moderate probability of disease benefit the most from the study when the diagnosis is in question.

Selection of tests should be made within the context of other tests, scheduled and previously performed, so that the anticipated information obtained is unique and not redundant.

Limitations:

Special Equipment Requirements:

Given the limitations of uptake, low photon energy and redistribution, the cardiac blood pool codes and perfusion imaging codes are not generally covered on the same date of service. However, in light of the predictive value of exercise-induced changes in ejection fraction, an exception will be made to allow first pass, single study with exercise along with the appropriate perfusion studies. Providers who bill this service must certify within their records that their laboratories are specially equipped to process such studies.

The rapid uptake, relatively low photon energy and redistribution of thallium 201 preclude its application to studies for gated images in most laboratories. However, an exception will be made to allow this combination for laboratories that have at least double-headed cameras and the appropriate software to facilitate the count. Such providers must certify that their laboratories are specially equipped to process such studies.

Cardiac blood pool imaging studies with appropriate add-on may be reported on a single date of service.

All cardiovascular nuclear tests and stress tests must be referred by a physician or a qualified non-physician provider.

All stress tests must be performed under the direct supervision of a physician. The nuclear test components must be performed under the general supervision of a physician.

Myocardial perfusion studies performed based on the presence of risk factors in the absence of cardiac symptoms, cardiac abnormalities on physical examination, or abnormalities on cardiac testing (e.g., electrocardiographic tests, echocardiography, etc) will be considered screening and denied as not covered by Medicare.

Tests that are anticipated to provide information duplicative of another test already performed will be denied as not medically necessary.

Tests performed when the results would not be anticipated to influence medical management decisions will be denied as not medically necessary.

Myocardial perfusion studies performed subsequent to a diagnostic myocardial PET scan will denied as not medically necessary.

Infarct avid scintigraphy will be denied if the diagnosis of myocardial infarction has already been confirmed by enzymes and/or EKG.

Tests performed unrelated to changes in a patient's signs or symptoms, or for immediate pre-operative evaluation will be denied as medically unnecessary.

Tests performed for risk assessment prior to high risk non-cardiac surgery in asymptomatic patients within one year following normal catheterization or non-invasive test will be considered medically unnecessary and denied.

Tests performed for preoperative evaluation in patients undergoing low-risk surgery will be denied.

Other Comments:

For claims submitted to the Part A MAC: this coverage determination also applies within states outside the primary geographic jurisdiction with facilities that have nominated CGS to process their claims.


Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes.

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This bibliography presents those sources that were obtained during the development of this policy. CGS is not responsible for the continuing viability of Web site addresses listed below.

American College of Cardiology - Self Assessment Program Syllabus.

Botnovich E, Dae M, O'Connell W, Ortendahl D, Hatner R. The scinitigraphic evaluation of the cardiovascular system. Cardiology Parmley (Ed).1994.

Brindis RG, Douglas PS, Hendel RC, et al. ACCF/ASNC appropriateness criteria for single-photon emission computed tomography myocardial perfusion imaging (SPECT MPI): A Report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group and the American Society of Nuclear Cardiology. J. Am Coll Cardiology (2005);46:1587-1605.

Committee on Exercise Testing, ACC/AHA Guidelines for Exercise Testing. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. July 1997;30(1):260-311.

Fleisher LA, Beckman JA, Brown KA, et al. ACC/AHA 2007 Guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery): Developed in Collaboration With the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery. J Am Coll Cardiol (2007);50:1707-1732.

Johnson LL, Rodney RA, Vaccarino RA, et al. Left ventricular perfusion and performance from a single radiopharmaceutical and one camera. J Nucl Med 1992;33:1411-1416.

Klocke FJ, Baird MG, Bateman TM, et al. ACC/AHA/ASNC Guidelines for the clinical use of cardiac radionuclide imaging: a report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASNC Committee to revise the 1995 guidelines for the clinical use of radionuclide imaging). 2003: downloaded from http://www.acc.org/clinical/guidelines/radio/rni_fulltext.pdf.

Lee T, Cardiac Noninvasive Testing. In: Braunwald E, Goldman L. editors, Primary Cardiology. 2nd edition. Elsevier Science 2003:47-61.

McFalls EO, Ward HB, Moritz TE, et al. Coronary-artery revascularization before elective major vascular surgery. NEJM 2004;351:2795-2804

Palmas W, Friedman JD, Diamond GA, Silber H, Kiat H, Berman D. Incremental value of simultaneous assessment of myocardial function and perfusion with technetium-99m sestamibi for prediction of extent of coronary artery disease. JACC. 1995;25(5):1024-1031.

Shaw LJ, Heinle SK, Borges-Neto S, Kesler K, Coleman RE, Jones RH for the Duke Noninvasive Research Working Group. Prognosis by measurements of left ventricular function during exercise. J Nucl Med 1998;39:140-146.

St John Sutton, MG, Rutherford JD, editors. Clinical Cardiovascular Imaging: A Companion to Braunwald's Heart Disease. Elsevier Saunders. 2004.

Wachers FJ, Soufer R, Zaret BL. Nuclear Cardiology. In: Heart Disease: A textbook of Cardiovascular Medicine. 6th edition. Braunwald E, Zipes D and Libby P, editors. 2001:273-304

Ward RP, Mouaz HA, Grossman GB, et al. American Society of Nuclear Cardiology review of the ACCF/ASNC appropriateness criteria for single-photon emission computed tomography myocardial perfusion imaging (SPECT MPI). J Nucl Cardiol 2007;14:e26-38.

Zaret BL, Beller GA. Nuclear Cardiology, State of the Art and Future Directions. Mosby 1999.

The following source was used in reviewing a reconsideration request in November, 2008:

Mariano-Goulart D, Dechaux L, Rouzet F, et al. Diagnosis of diffuse and localized arrhythmogenic right ventricular dysplasia by gated blood-pool SPECT. The Journal of Nuclear Medicine. Sept 2007;48(9):1416-1423.

In review of a reconsideration request for July 2009, the New York Cardiology CAC representative was consulted.

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