Cardiac Computed Tomography (CCT) and Coronary Computed Tomography Angiography (CCTA)

Language quoted from Center 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.

Section 1862 (a)(7) excludes routine physical examinations.

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 100-3, National Coverage Determination Manual, Chapter 1
220.1 Computerized Tomography

CMS Publication 100-4, Medicare Claims Processing Manual, Chapter 13
20 Payment Conditions for Radiology Services

CMS Publication 100-9, Contractor Beneficiary and Provider Communication Manual, Chapter 5
20 Correct Coding Initiative

Abstract:

The multidetector helical computed tomography (MDCT) technology requires thin (up to 1 mm) slices, 0.5 to 0.75 mm reconstructions, multiple simultaneous images (e.g. 16, 32, 64 or more slices), and cardiac gating (often requiring beta blockers for ideal heart rate). There is significant post-processing, depending on the number of slices per second for image generation. For coronary artery imaging, the resulting images show a high correlation with stenotic lesions noted on diagnostic cardiac catheterization but more importantly, with atheromas on intracoronary ultrasound.

Current available body of evidence demonstrates that CCTA can reliably rule out the presence of significant coronary artery disease (CAD) in patients with a low to intermediate probability of having CAD and can reliably achieve a high degree of diagnostic accuracy and technical performance necessary to replace conventional angiography.

Indications:

1. Patient presenting with chest pain syndrome.
   
   These tests may be used in lieu of an imaging stress test. The clinician must have a high degree of suspicion that CAD is high on the differential diagnosis of the symptoms.
   
   
2. To facilitate the management decision of a patient with an equivocal stress test.
   
   These tests might be chosen in select patients who have an equivocal stress (or stress imaging) test. The rationale is that a noninvasive coronary anatomic test (CCTA) allows an alternate method of assessing the coronary arteries, which would limit the number of negative invasive coronary angiograms.
   
   
3. When the recurrence of symptoms in patients with known coronary artery disease may be related to progression/exacerbation of underlying disease.
   
   The use of these tests in this setting would be to evaluate the extent of previously diagnosed coronary artery disease. Patients with known disease may have had remote invasive angiography and/or stress testing to evaluate prior events or symptoms. New or recurrent symptoms may relate to a change in the coronary anatomy that can be assessed with these tests.
   
   
4. When patients with prior bypass surgery or intracoronary artery stent placement present with chest pain or dyspnea.
   
   Coronary bypass grafts are relatively well seen with these tests. The rationale for the tests would be to determine the patency and severity of possible graft stenoses that may be the source of chest pain. Patients with prior intracoronary stents often present with recurrent chest pain. The rationale for these tests as an alternative to invasive angiography is to rule out in-stent restenosis as the cause of symptoms. (Accurate assessment of in-stent restenosis may be limited by the artifact caused by the stent material itself and the quality of the scan and scanner).
   
   
5. Suspected congenital anomalies of the coronary circulation.
   
   These tests are used to assess patients suspected of having a congenital coronary anomaly. The cross-sectional nature of this technique allows one to determine accurately both the presence and possible future harm that could result from the anomaly. It is often used after an anomaly has been identified following a different test such as prior invasive coronary angiogram. These tests are used to decide if surgery is indicated and for surgical planning.
   
   
6. The assessment of coronary or pulmonary venous anatomy.
   
   This application of the tests for the coronary and pulmonary veins is primarily for pre-surgical planning. Coronary venous anatomy can be useful for the cardiologist who needs to place a pacemaker lead in the lateral coronary vein in order to resynchronize cardiac contraction in patients with heart failure. This may be helpful to guide biventricular pacemaker placement.
   
   Pulmonary vein anatomy can vary from patient to patient. Pulmonary vein catheter ablation can isolate electrical activity from the pulmonary veins and allow for the elimination of recurrent atrial fibrillation. The presence of a pulmonary venous anatomic map may help eliminate procedural complications and allow for the successful completion of the procedure.
   
   
7. The patient undergoing non-coronary artery cardiac surgery.
   
   Certain patients who have non-coronary artery cardiac surgery (valve or ascending aortic surgery) may need a pre-operative invasive coronary angiogram. The surgical planning may also depend upon the exact location of the coronary arteries. The rationale for the use of CCTA in these patient subsets is to avoid potentially unnecessary invasive testing and still provide appropriate pre-surgical information.
   
   
8. The test may be medically necessary in patients presenting to the emergency room with complaints consistent with cardiac ischemia, but without diagnostic electrocardiography (ECG) or enzymes.
   
   
9. The test may be considered medically necessary in patients status post revascularization procedures who present with recurrent symptoms not clearly identifiable as ischemic.
   
   

Limitations:

1. These tests are never covered for screening, i.e., in the absence of signs, symptoms or disease.
   
   
2. These tests will be considered not medically necessary if the anticipated results are not expected to provide new, additional information to that already previously obtained from other tests (such as stress myocardial perfusion images or cardiac ultrasound). New or additional information should facilitate the management decision, not merely add a new layer of testing.
   
   
3. These tests will be considered not medically necessary if it is anticipated that the patient would require invasive cardiac angiography for further diagnosis or for therapeutic intervention. (e.g., angina decubitus, unstable angina, Prinzmetal angina, etc.)
   
   
4. These tests may be denied, on post-pay review, as not medically necessary when used for cardiac evaluation if there were pre-test knowledge of sufficiently extensive calcification of the suspect coronary segment that would diminish the interpretive value.
   
   
5. The administration of beta blockers and the monitoring of the patient during MDCT/CCTA by a physician experienced in the use of cardiovascular drugs is included as part of the test and is not a separately payable service.
   
   
6. All studies must be ordered by the physician/qualified non-physician practitioner treating the patient and who will use the results of the test in the management of the patient.
   
   
7. CCTA must be performed under the direct supervision of a physician.
   
   
8. This LCD does not address electron beam tomography (EBT) technology or Ultrafast CT for coronary artery examination. There is no extension of coverage of EBT based on this policy.
   
   
9. Quantitative calcium scoring is not a covered service and will be denied as not medically necessary. Calcium scoring reported in isolation is considered a screening service. When performed in association with CT angiography, there is neither separate nor additional included reimbursement for the calcium scoring.
   
   
10. Acceptable Levels of Competence for Performance and Interpretation: Providers submitting claims for these tests must demonstrate proficiency and training in performing the tests according to the following standards:
    
    

The acceptable levels of competence, as defined by the American College of Cardiology (ACC)/American Heart Association (AHA) Clinical Competence Statement on Cardiac Imaging with Computed Tomography and Magnetic Resonance (2005) and the American College of Radiology (ACR) Clinical Statement on Noninvasive Cardiac Imaging (2005), are outlined as follows:

For the technical portion, a recommended level of competence is fulfilled when the image acquisition is obtained under all of the following conditions:

1.  The service is performed by a radiology technologist who is credentialed by a nationally recognized credentialing body (American Registry of Radiologic Technologists or equivalent) and meets state licensure requirements where applicable.
2. If intravenous beta blockers or nitrates are to be given prior to a CT coronary angiogram, the test must be under the direct supervision of a physician (familiar with the administration of cardiac medications), who should be available to respond to medical emergencies. It is also strongly recommended that the physician be ACLS certified.
3. When contrast studies are performed, the physician must provide direct supervision and the radiologic technologist or registered nurse administering the contrast must have appropriate training on the use and administration of contrast media.

For the professional portion, a recommended level of competence is fulfilled when the interpretation is performed by a physician meeting the following requirements:

1.  The physician has appropriate additional training in coronary CTA and cardiac CT imaging equivalent to the guidelines set forth by the ACC or ACR (for example: the ACCF/AHA Clinical Competence Statement on Cardiac Imaging with Computed Tomography and Magnetic Resonance (2005) and the ACR Clinical Statement on Noninvasive Cardiac Imaging (2005)), or
2. The physician has appropriate medical staff privileges to interpret CT coronary angiograms at a hospital that participates in the Medicare program, and is actively training in cardiac CT (as in paragraph a). A grace period of 24 months will be allowed to acquire the necessary training.

N/A

N/A

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

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Sources added for FFR, revision effective 01/01/2018:

•  Benton SM, Tesche C, De Cecco CN, Duguay TM, Schoepf UJ, Bayer RR. Noninvasive derivation of fractional flow reserve from coronary computed tomographic angiography: a review. J Thorac Imaging. 2018;33(2):88-96.

• Cohen MC, Garcia MJ, Hodgson JM, et al.ACCF/AHA Clinical competence statement on cardiac imaging with computed tomography and magnetic resonance. 2005;46(2). Focused Update: J Amer Coll Cardiol. 2009;54(25):2463-4.

• De Bruyne B, Fearon WF, Pijls NH, et al. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. 2014;371(13):1208-1217.

• Koo BK, Erglis A, Doh JH, et al. Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. Results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. J Am Coll Cardiol. 2011;58(19):1989-1997.

• Mark DB, Berman DS, Budoff MJ, et al. ACCF/ACR/AHA/NASCI/SAIP/SCAI/SCCT 2010 expert consensus document on coronary computed tomographic angiography: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents. Catheter Cardiovasc Interv. 2010;76(2):E1-42.

• Norgaard BL, Hjort J, Gaur S, et al, Clinical use of coronary CTA-derived FFR for decision making in stable CAD. JACC. 2016.

• Norgaard BL, Leipsic J, Gaur S, et al. Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps). J Am Coll Cardiol. 2014;63(12):1145-1155.

• Patel MR, Calhoon JH, Dehmer GJ, et al. ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 Appropriate use criteria for coronary revascularization in patient with stable ischemic heart disease. JACC.2017. 02(001).

• Rybicki FJ, Udelson JE, Peacock WF. et al.  ACR/ACC/AHA/AATS/ACEP/ASNC/NASCI/SAEM/SCCT/SCMR/SCPC/SNMMI/STR/STS Appropriate utilization of cardiovascular imaging in emergency department patients with chest pain. 2015;67(7).

N/A

• heart