LCD L35753

Coverage Guidance

Title XVIII of the Social Security Act section 1833 (e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Title XVIII of the Social Security Act section 1862 (a) (1) (A) allows coverage and payment of those items or services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act section 1862 (a) (1) (D) excludes Medicare payment for any expenses incurred for items or services that are investigational or experimental.

Title XVIII of the Social Security Act section 1862 (a) (7) excludes routine physical examinations and services from Medicare coverage.

42 CFR, Section 410.32 (a) Diagnosis x-ray tests, diagnostic laboratory tests, and other diagnostic tests 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 patient are not reasonable and necessary (see 42 CFR 411.15(k) (1).

42 CFR, Section 410.32 (b) Diagnostic x-ray and other diagnostic tests. (1) Basic rule. .. all diagnostic x-ray and other diagnostic tests covered under section 1861(s)(3) of the Act and payable under the physician fee schedule must be furnished under the appropriate level of supervision by a physician as defined in section 1861® of the Act. Services furnished without the required level of supervision are not reasonable and necessary. (see 42 CFR 411.15(k)(1)).

CMS Pub 100-02 Medicare Benefit Policy Manual, Chapter 15 – Covered Medical and Other Health Services, Section 80 – Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests.

CMS Pub 100-03 Medicare National Coverage Determinations Manual, Chapter 1 – Coverage Determinations Part 1, Section 20.17 - Noninvasive Tests of Carotid Function.

Part 4, Sections

220.5 - Ultrasound Diagnostic Procedures and

300.1 - Obsolete or Unreliable Diagnostic Tests.

CMS Pub 100-04 Medicare Claims Processing Manual, Chapter 13 – Radiology Services and Other Diagnostic Procedures, Sections –

10.1 - Billing Part B Radiology Services and Other Diagnostic Procedures and

20 – Payment Conditions for Radiology Services.

Chapter 16 – Laboratory Services, Section 40.2 – Payment Limit for Purchased Services.

CMS Pub 100-08, Medicare Program Integrity Manual, Chapter 13 – Local Coverage Determinations, Section 13.5.1 – Reasonable and Necessary Provisions in LCDs.

CMS Publication 100-09, Medicare Contractor Beneficiary and Provider Communications Manual, Chapter 5 - Correct Coding Initiative.

Indications and Limitations of Coverage

Overview

Non-invasive cerebrovascular studies utilize ultrasonic Doppler and physiological principles to assess the irregularities in blood flow in arterial and venous systems. Noninvasive vascular studies include the patient care required to perform the studies, supervision of the studies, and interpretation of study results, with copies for patient records of test results and analysis of all data, including bi-directional vascular flow or imaging when provided.

Diagnostic tests must be ordered by the physician who is treating the beneficiary and use the result in the management of the beneficiary’s specific medical problem. Services are deemed medically necessary when all of the following conditions are met:

• Signs/symptoms of ischemia or altered blood flow are present;

• The information is necessary for appropriate medical and/or surgical management;

• The test is not redundant of other diagnostic procedures that must be performed. Although, in some circumstances, non-invasive vascular tests are complimentary, such as MRA and duplex, where the latter may confirm an indeterminate finding or demonstrate the physiological significance of an anatomic stenosis (especially in the carotids and lower extremity arterial system).

Definitions:

Duplex Scans: Duplex combines Doppler and conventional ultrasound, allowing the structure of blood vessels, how the blood is flowing through the vessels, and whether there is any obstruction in the vessels to be seen. Color Doppler produces a picture of the blood vessel, and a computer converts the Doppler sounds into colors overlaid on the image, representing information about the speed and direction of blood flow. Using spectral Doppler analysis, the duplex scan images provide anatomic and hemodynamic information, identifying the presence of any stenosis or plaque in the arteries. Duplex scans are in real-time.

Transcranial Doppler: Pulsed Doppler ultrasound is used to interrogate the intracranial vasculature of the Circle of Willis. It detects severe stenosis in the major intracranial arteries, assesses patterns and extent of collateral circulation in patients with known regions of severe stenosis or occlusion and evaluating and following patients with vasoconstriction particularly after a subarachnoid hemorrhage.

Cerebrovascular Studies

Extracranial Arteries Studies

Testing methods that include (real-time) duplex scans and Doppler ultrasound waveform with spectral analysis are covered for the following:

Indications:

• Cervical bruits.

• Amaurosis fugax (transient monocular blindness).

• Focal cerebral or ocular transient ischemic attacks.

• Drop attack or syncope is only covered with vertebrobasilar or bilateral carotid artery disease as suggested by the patient’s history. If an echocardiogram is negative for a cardiac or cardiac valvular cause, it may be medically appropriate to perform extracranial arteries studies for the drop attack or syncope.

• Subclavian steal syndrome (symptoms usually associated with it are a bruit in the subclavian fossa, unequal radial pulses, arm claudication following minimal exercise, and a difference of 20 mm Hg or more between the systolic blood pressures in the arms).

• Evaluation of blunt or penetrating neck trauma or injury to the carotid artery.

• Follow-up after a carotid endarterectomy or carotid stenting.

• Suspected aneurysm of the carotid artery. Patients with swelling of the neck particularly if occurring post carotid endarterectomy.

• Re-evaluation of existing carotid stenosis.

• Evaluation of pulsatile neck mass.

• Preoperative evaluation of patient scheduled for major cardiovascular surgical procedure when there is evidence of systemic atherosclerosis.

• Preoperatively validate the degree of carotid stenosis of patients whose previous duplex scan revealed a greater than 60% diameter reduction. The duplex is only covered when the surgeon questions the validity of the previous study, and the repeat test is performed in lieu of a carotid arteriogram.

• Ocular micro embolism (optic nerve/retinal arterial - Hollenhorst plaques/ocular).

• Evaluation of suspected dissection.

• Recent stroke (defined as less than 6 months) for determining the cause of the stroke.

• Vasculitis involving the extracranial carotid arteries.

• Diagnosis of carotid disease on medical management and cerebrovascular symptoms are reoccurring.

• Pulsatile tinnitus with other symptoms involving the cardiovascular system.

Limitations:

Tests may not be considered medically necessary if performed for the following signs and symptoms:

• Dizziness is not a typical indication unless associated with other localizing neurologic signs or symptoms.

• Headaches including migraines.

• Temporarily blurred vision.

Transcranial Doppler Testing

Indications:

• Detection and evaluation of the hemodynamic effects of severe stenosis or occlusion of extracranial (greater than or equal to 60% diameter reduction) and major basal intracranial arteries (greater than or equal to 50% diameter reduction).

• Detection and serial evaluation of cerebral vasospasm with spontaneous or traumatic subarachnoid hemorrhage.

• Evaluation of intracranial hemodynamic abnormalities in patients with suspected brain death. It would be expected that an EEG for cerebral death evaluation would be used to diagnose brain death before a Doppler.

• Intraoperative and perioperative monitoring of intracranial flow velocity and hemodynamic patterns during carotid endarterectomy or carotid stenting.

• Evaluation of cerebral embolization.

• As an alternative to an echocardiogram when detecting residual right to left shunting after repair and/or closure of an intracardiac or intrapulmonary shunt.

• Detecting arteriovenous malformation and studying their supply arteries and flow pattern.

• Evaluation of invasive therapeutic interventions for cerebral malformations.

• Differentiating vertebrobasilar symptoms from carotid symptoms.

• Assessing tandem lesions (>65% in the major basal intracranial arteries when extra cranial studies fail to identify the problem).

• Evaluation of the risk for stroke in individuals diagnosed with sickle cell.

Limitations:

It is not medically reasonable and necessary and therefore not covered for:

• Evaluation of brain tumors.

• Assessment of familial and degenerative disease of the cerebrum, brainstem, cerebellum, basal ganglia, and motor neurons.

• Evaluation of infectious and inflammatory conditions.

• Psychiatric disorders.

• Epilepsy.

• Routine evaluation of cerebrovascular symptoms and signs.

The following are considered investigational and not medically necessary:

• Assessment of migraines or suspected migraines.

• Evaluation of dilated vasculopathies such as fusiform aneurysms.

• Assessment of autoregulation, physiologic and pharmacologic responses of cerebral arteries.

• Monitoring during cardiopulmonary bypass and other cerebrovascular and cardiovascular interventions, and surgical procedures except during a carotid endarterectomy.

• Evaluation of children with various vasculopathies, such as moyamoya disease and neurofibromatosis.

Credentialing and Accreditation Standards

The accuracy of non-invasive vascular diagnostic studies depends on the knowledge, skill, and experience of the technologist and interpreter. Consequently, the physician performing and/or interpreting the study must be capable of demonstrating documented training and experience. A vascular diagnostic study may be personally performed by a certified technologist, or in a certified vascular testing lab.

Services will be considered medically reasonable and necessary only if performed by appropriately trained providers.

• All non-invasive vascular diagnostic studies must be performed meeting at least 1 of the following:

• performed by a licensed qualified physician, or

• performed by a technician who is certified in vascular technology, or

• performed in facilities with laboratories accredited in vascular technology.

• A licensed qualified physician for these services is defined as:

• Having trained and acquired expertise within the framework of an accredited residency or fellowship program in the applicable specialty/subspecialty in ultrasound (US) or must reflect equivalent education, training, and expertise endorsed by an academic institution in ultrasound or by applicable specialty/subspecialty society in ultrasound, or

• Has the Registered Vascular Technologist (RVT), Registered Physician Vascular Interpretation (RPVI), or American Society of Neuroimaging (ASN): Neuroimaging Subspecialty Certification; and

• Is able to provide evidence of proficiency in the performance and interpretation of each type of diagnostic procedure performed.

• Nonphysician personnel performing tests must demonstrate basic qualifications to perform tests and have training and proficiency as evidenced by licensure or certification by an appropriate State health or education department. In the absence of a State licensing board, non-physician personnel must be certified by an appropriate national credentialing body.

Appropriate personnel certifications include the American Registry of Diagnostic Medical Sonographers (ARDMS) Registered Vascular Technologist or (RVT) credential; or Cardiovascular Credentialing International’s Registered Vascular Specialist (RVS).

Laboratories must be certified by one of the following:

• Intersocietal Accreditation Commission (IAC),

• American College of Radiology (ACR),

• Joint Commission (Vascular lab certification would need to be noted under the main certification either under inpatient or ambulatory care depending on where the test is being performed), or

• DNV-GL (specific for hospitals only)

According to which certifying body listed above is selected, that accrediting body’s standards must be followed.

Summary of Evidence

N/A

Analysis of Evidence

N/A

Associated Information

Documentation Requirements

Adequate documentation is essential for high-quality patient care and to demonstrate the reasonableness and medical necessity of the study(ies). Documentation must support the criteria for coverage as described in the Coverage Indications, Limitations, and/or Medical Necessity section of this LCD. There should be a permanent record of the studies performed and the interpretation. The documentation should include a description of the studies performed and any contrast media and/or radiopharmaceuticals used. Any known significant patient reaction or complications should be recorded. Comparison with prior relevant studies needs to be addressed in the documentation along with both normal and abnormal findings. Variations from normal should be documented along with the measurements. The report should address or answer any specific clinical questions. If there are factors that prevent answering the clinical questions, this should be explained in the documentation. Retention of the ultrasound examination images should be consistent both with clinical need and with relevant legal and local health care facility requirements.

If the provider of the study is other than the ordering/referring physician/nonphysician practitioner, that provider must maintain a copy of the test results and interpretation, along with copies of the ordering/referring physician/nonphysician practitioner’s order for the studies. This order is required to provide adequate diagnostic information to the performing provider. The physician/nonphysician practitioner must state the clinical indication/medical necessity for the study in his/her order for the test. The provider is responsible for ensuring the medical necessity of procedures and maintaining the medical record, which must be available to Medicare upon request. Results of all testing must be shared with the referring physician. Non-invasive vascular studies are medically reasonable and medically necessary only if the outcomes will be utilized in the clinical management of the patient.

Documentation must be provided supporting the need for more than one imaging study or a repeat preoperative scan.

Utilization Guidelines

Each patient’s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each study reported to be clearly documented in the patient’s medical record.

Frequency of follow-up studies will be carefully monitored for medical necessity, and it is the responsibility of the physician/provider to maintain documentation of medical necessity in the patient’s medical record.

Only 1 Doppler preoperative scan is considered reasonable and necessary for bypass surgery. If a more current preoperative scan is indicated for a patient with multiple comorbidities having difficulty being stabilized for surgery or a change in condition, the medical record would need to support the medical necessity of the second scan.

Re-evaluation of existing carotid stenosis. Patients demonstrating a diameter reduction of greater than 50% with symptoms and those patients with > 60% with no symptoms are normally followed on an annual basis. If patients become symptomatic of carotid disease repeat duplex scans are allowed without regard to the above schedule.

Follow-up after a carotid endarterectomy (outside the global period). These patients are normally followed with duplex ultrasonography on the affected side at 6 weeks, 6 months, and annually thereafter unless symptoms develop. During the first year, follow-up studies should be on the ipsilateral side unless signs and symptoms or previously identified disease in the contralateral carotid artery provide indications for a bilateral procedure.

Multiple cerebrovascular procedures may be allowed during the same encounter given the physician/non-physician can demonstrate medical necessity as documented in the patient’s medical record.

Preventive and/or screening services unless covered in Statute are not covered by Medicare.

Bibliography

• Adams HP, del Zoppo G, Alberts MJ, et al. Guidelines for the early management of adults with ischemic stroke. Circulation. 2007;115(20).

doi:10.1161/circulationaha.107.181486

• Brott TG, Halperin JL, Abbara S, et al. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients WITH Extracranial carotid and vertebral Artery disease: Executive summary. Stroke. 2011;42(8). doi:10.1161/str.0b013e3182112d08

• Brown OW, Bendick PJ, Bove PG, et al. Reliability of extracranial carotid artery duplex ultrasound scanning: Value of vascular laboratory accreditation. Journal of Vascular Surgery. 2004;39(2):366-371. doi:10.1016/j.jvs.2003.08.018

• Gerhard-Herman M, Gardin JM, Jaff M, Mohler E, Roman M, Naqvi TZ. Guidelines for noninvasive Vascular LABORATORY Testing: A report from the American Society of echocardiography and the Society of Vascular medicine and biology. Journal of the American Society of Echocardiography. 2006;19(8):955-972. doi:10.1016/j.echo.2006.04.019

• Goldstein LB, Adams R, Becker K, et al. Primary prevention of ischemic stroke. Stroke. 2001;32(1):280-299. doi:10.1161/01.str.32.1.280

• Lovelace TD, Moneta GL, Abou-Zamzam AM, Edwards JM, et al. Optimizing duplex follow-up in patients with an asymptomatic internal carotid artery stenosis of less than 60%. Journal of Vascular Surgery. 2001;33(1):56-61.

• Ricotta JJ, AbuRahma A, Ascher E, Eskandari M, Faries P, Lal BK. Updated society for vascular Surgery guidelines for management Of extracranial CAROTID disease: Executive summary. Journal of Vascular Surgery. 2011;54(3):832-836. doi:10.1016/j.jvs.2011.07.004

• Rothwell PM, Goldstein LB. Carotid endarterectomy for Asymptomatic Carotid Stenosis. Stroke. 2004;35(10):2425-2427. doi:10.1161/01.str.0000141706.50170.a7

• Sloan MA, Alexandrov AV, Tegeler CH, et al. Assessment: Transcranial DOPPLER ULTRASONOGRAPHY: [RETIRED]. Neurology. 2004;62(9):1468-1481. doi:10.1212/wnl.62.9.1468