Non-Invasive Cerebrovascular Arterial Studies

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for non-invasive cerebrovascular arterial studies services. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for non-invasive cerebrovascular arterial studies services and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:

IOM Citations:

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests
• CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1,
  • Part 1, Section 20.14 for Plethysmography
  • Part 1, Section 20.17 for Noninvasive Tests of Carotid Function
  • Part 4, Section 220.5 for Ultrasound Diagnostic Procedures
  • Part 4, Section 220.11 for Thermography
• CMS IOM Publication 100-04, Medicare Claims Processing Manual, 
  • Chapter 13, Section 10 ICD Coding for Diagnostic Tests and Section 20 Payment Conditions for Radiology Services 
• CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 Reasonable and Necessary Provisions in LCDs

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.
• Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Non-invasive tests for cerebrovascular arterial function document the nature, location, extent and severity of disease in extracranial and intracranial vessels, including the carotid and vertebral arteries. “Vascular studies include patient care required to perform the studies, supervision of the studies and interpretation of study results with copies for patient records of hard copy output with analysis of all data, including bidirectional vascular flow or imaging when provided.” (AMA 2018 CPT book, page 654). A hard copy or a soft copy convertible to a hard copy provides a permanent record of the study performed and must be of a quality that meets accepted radiologic/ultrasonographic standards.

Any vascular studies performed should be as a result of, or to complement, a thorough patient evaluation and neurological examination.

For information on noninvasive tests of carotid function, please see CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1 Part 1, Section 20.17.

There are numerous tests that measure various aspects of vascular anatomy and physiology as follows:

Direct tests:

•Carotid Phonoangiography
•Direct Bruit Analysis
•Spectral Bruit Analysis
•Doppler Flow Velocity
•Ultrasound imaging including Real Time
•B-scan and Doppler Devices

Indirect tests:

•Periorbital Directional Doppler Ultrasonography
•Oculoplethysmography
•Ophthalmodynamometry

Extracranial cerebrovascular testing uses duplex ultrasonography as the primary testing technique. Protocols must encompass both real-time gray scale imaging (B-mode) and analysis of the angle corrected Doppler spectrum.

Duplex Scan

This procedure combines high-resolution B-mode real-time imaging with Doppler ultrasound and spectral analysis. The scan provides anatomic and hemodynamic characterization of the cervical carotid and vertebral arteries as well as characterization of the atheromatous plaque. Color-flow Doppler is used to enhance conventional data acquisition.

Transcranial Doppler

Pulsed Doppler ultrasound is used to interrogate the intracranial vasculature of the Circle of Willis. Its value has been established in detecting severe stenoses in the major intracranial arteries, assessing 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 subarachnoid hemorrhage.

For coding guidelines, please refer to Article A52992, Billing and Coding: Non-Invasive Cerebrovascular Arterial Studies.

Covered Indications

1. The following are covered indications for Duplex scans, Doppler Ultrasound with Spectrum Analysis, Ocular Pneumoplethysmography, and Periorbital Doppler:

• Evaluation of patients with a cervical bruit
• Evaluation of pulsatile neck masses
• Evaluation of patients with hemispheric neurologic symptoms, including stroke, transient ischemic attack and amaurosis fugax
• Follow-up of patients with proven carotid disease who are receiving medical therapy
• Follow-up for postoperative patients following carotid endarterectomy, stenting or carotid to subclavian bypass
• Evaluation of suspected subclavian steal syndrome
• Evaluation of retinal arterial emboli
• Evaluation of suspected carotid artery dissection or pseudoaneurysm
• Evaluation of sudden and lateralizing neurologic deficit
• Established or symptomatic coronary artery disease or cardiac valvular disease
• "Drop attacks" or syncope when there are documented signs or symptoms consistent with vertebral basilar or carotid artery disease or insufficiency

2. The following are covered indications for Transcranial Doppler (TCD):

• Detection and follow up of severe stenosis in the major basal intracranial arteries
• Assessment of patterns and extent of collateral circulation in patients with known regions of severe cerebral stenosis or occlusion
• Intraoperative and perioperative monitoring of intracranial flow velocity and hemodynamic patterns during carotid endarterectomy
• Detection and monitoring of vasospasm in patients with spontaneous or traumatic subarachnoid hemorrhage
• Detection and follow up of cerebral arteriovenous malformations
• Confirmation of the clinical diagnosis of brain death
• Evaluation of invasive therapeutic interventions for cerebral malformations
• Evaluation of cerebral embolization
• "Drop attacks" or syncope when there are documented signs or symptoms consistent with vertebral basilar or carotid artery disease or insufficiency

Limitations

1. Non-invasive vascular studies done for screening purposes (i.e., without signs or symptoms of disease) are considered not reasonable and necessary and are therefore non-covered by Medicare. Examples of screening studies include but are not limited to:

• Extracranial arterial studies performed as part of a cardiovascular preoperative workup in the absence of signs or symptoms of disease are screening services and as such are non-covered by Medicare.
• Subclavian ultrasound studies routinely performed in conjunction with carotid ultrasounds in the absence of signs or symptoms of disease are screening services and as such are non-covered by Medicare.

2. Non-invasive vascular studies are considered not reasonable and necessary if the results are not needed for clinical decision making. If the study results will have no impact on the decision for further diagnostic or therapeutic procedures or will not provide any unique diagnostic information that would impact patient management, then the non-invasive studies are not reasonable and necessary. For example, if it is evident from the findings of the history and physical examination that the patient is going to proceed to angiography, then non-invasive vascular studies are not reasonable and necessary.

3. Transcranial cerebral vascular studies including but not limited to the following conditions are not covered:

• Evaluation of brain tumors
• Assessment of familial and degenerative diseases of the cerebrum, brainstem, cerebellum, basal ganglia and motor neurons
• Evaluation of infectious and inflammatory conditions
• Evaluation of psychiatric disorders
• Epilepsy
• Assessing patients with migraine or headache
• Monitoring during cardiopulmonary bypass and other cerebrovascular and cardiovascular interventions, and other surgical procedures
• Evaluation of patients with dilated vasculopathies such as fusiform aneurysms
• Assessing autoregulation, physiologic, and pharmacological responses of cerebral arteries
• Evaluating various vasculopathies such as sickle cell disease, moya moya disease, and neurofibromatosis

4. Please see coverage information in CMS IOM 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Section 20.14 for Plethysmography, Section 20.17 for Oculoplethysmography and Chapter 1 Part 4, Section 220.11 for Thermography. In addition to the limitations outlined in the above NCD references, the following methods are not acceptable for reimbursement of Duplex scans of the extracranial arteries or Transcranial Doppler studies of the intracranial arteries:

• Light reflection rheography
• Pulse Delay Oculoplethysmography
• Carotid Phonoangiography and other forms of bruit analysis are included in the reimbursement for the office visit
• Periorbital Photoplethysmography

5. The following limitations apply to multiple non-invasive studies performed during the same encounter:

• Performance of both non-invasive extracranial arterial studies and non-invasive evaluation of extremity veins during the same encounter is rarely medically necessary. Documentation must clearly support the medical necessity if both procedures are performed during the same encounter and be made available upon request.
• Because signs and symptoms of arterial occlusive disease and venous disease are so divergent, the performance of simultaneous arterial and venous studies during the same encounter is rarely medically necessary. Consequently, documentation must clearly support the medical necessity of both procedures if performed during the same encounter and be made available upon request.

6. “The use of a simple hand-held or other Doppler device that does not produce hard copy output, or that produces a record that does not permit analysis of bidirectional vascular flow, is considered to be part of the physical examination of the vascular system and is not separately reported.” (AMA 2018 CPT book, page 654) Doppler procedures performed with zero-crossers (i.e., analog [strip chart recorder] analysis) are also included in any Evaluation/Management (E/M) service. Therefore, it is considered not reasonable and necessary to report these procedures as separate services.

Training Requirements/Certifications

The accuracy of non-invasive diagnostic testing studies depends on the knowledge, skill and experience of the physician and/or technologist performing and interpreting the study. Documentation of applicable training and experience must be maintained and made available upon request. Services will be considered reasonable and necessary only if performed by appropriately trained personnel. Please see CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80 for information regarding supervision definitions and requirements.

All non-invasive vascular studies must be:

1. Performed by a qualified physician; or

2. Performed under the general supervision of a qualified physician by a licensed* technologist who is certified in vascular technology; or

3. Performed in an accredited vascular laboratory.

*State licensure for a technologist is required in addition to appropriate recognized certification. Documentation of current, active licensure must be maintained and made available upon request. In the absence of a state/federal district licensing board, the requirement for licensure is waived.

A qualified physician for this service/procedure is defined as:

A) Physician is properly enrolled in Medicare; and

B) Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty in the United States or must reflect equivalent education, training, and expertise endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States.

Appropriate technologist certification is limited to American Registry of Diagnostic Medical Sonographers (ARDMS) certification as a Registered Vascular Technologist (RVT), Cardiovascular Credentialing International (CCI) certification as a Registered Vascular Specialist (RVS), and the American Registry of Radiologic Technologists (ARRT) certification in Vascular Sonography (VS). Appropriate laboratory accreditation is limited to the American College of Radiology (ACR) Vascular Ultrasound Program, and the Intersocietal Accreditation Commission (IAC) division of Vascular Testing.

The contractor does not establish a credentialing service but the contractor is authorized to determine which organizations it recognizes. For example, the use of the word “national” in the organization’s name does not, in itself, meet Medicare standards for national credentialing.

Note: For services performed in an Independent Diagnostic Testing Facility (IDTF), please refer to Local Coverage Determination (LCD) L35448, Independent Diagnostic Testing Facility (IDTF), and related Local Coverage Article A53252, Independent Diagnostic Testing Facility (IDTF), for additional information.

This LCD imposes frequency limitations. Please refer to the Utilization Guidelines section below for information regarding limitations.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. Please refer to Billing and Coding: Non-Invasive Cerebrovascular Arterial Studies, A52992, for appropriate CPT and ICD-10 codes.

Please see CMS IOM 100-08, Chapter 13, Section 13.5.4, for information pertaining to reasonable and necessary provisions in LCDs.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.

N/A

N/A

Refer to the Local Coverage Article: Billing and Coding: Non-Invasive Cerebrovascular Arterial Studies, A52992, for all coding information.

Documentation Requirements

1. All documentation must be maintained in the patient’s medical record and made available to the contractor upon request.
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
3. The medical record documentation must support the medical necessity of the services as stated in this policy.
4. The patient's medical record must contain a current, pertinent history and physical examination, and progress notes describing and supporting the indications for the services.
5. The medical record must contain any pertinent prior diagnostic testing and completed report(s).
6. The medical necessity for performing both non-invasive extracranial arterial studies and non-invasive evaluation of extremity veins during the same encounter must be clearly documented in the medical record.
7. The medical necessity for performing simultaneous arterial and venous studies during the same encounter must be clearly documented in the medical record.

Utilization Guidelines

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

For follow up of patients with known carotid disease who are receiving medical therapy:

• Stenosis of 20 percent to 50 percent (diameter reduction) - every 12 months.
• Stenosis of 50 percent to 99 percent (diameter reduction) - every six months.
• Medicare expects that few patients with high-grade carotid stenosis (80-99 percent) will be followed medically with repeated diagnostic testing. Because surgery or advanced imaging may be indicated for stenosis of 80 percent to 99 percent found on duplex scan, the medical record of patients followed medically with high-grade stenosis must unequivocally indicate medical necessity for repeated diagnostic testing.

After carotid endarterectomy, repeat duplex ultrasound examinations greater than three every 12 months are not covered. These examinations usually occur once at six weeks, once at six months and once at 12 months during the first year after surgery and then yearly, thereafter. Postoperatively, follow-up studies should be unilateral, unless signs and symptoms or known contralateral stenosis provide indications for a bilateral procedure. Therefore, the frequency of duplex scan services billed in any combination is limited to 3 per 12 months.

Notice: This LCD imposes utilization guideline limitations. Despite Medicare allowing up to these maximums, 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 service reported to be clearly demonstrated in the patient’s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services.

L27504 Non-Invasive Cerebrovascular Arterial Studies, Novitas Solutions Jurisdiction L Local Coverage Determination

L35448, Independent Diagnostic Testing Facility (IDTF), Novitas Solutions Jurisdiction H & L Local Coverage Determination

A53252 Independent Diagnostic Testing Facility (IDTF), Novitas Solutions Jurisdiction H & L Local Coverage Article

Other Contractor Policies

L33693, Non-Invasive Evaluation of Extremity Veins, First Coast Service Options Jurisdiction N Local Coverage Determination

L33695, Non-Invasive Extracranial Arterial Studies, First Coast Service Options Jurisdiction N Local Coverage Determination

L33977, Transcranial Doppler Studies, First Coast Service Options Jurisdiction N Local Coverage Determination

L34221, Noninvasive Cerebrovascular Studies, Noridian Healthcare Solutions Jurisdiction E Local Coverage Determination

Contractor Medical Directors

1. ACCF/ACR/AIUM/ASE/ASN/ICAVL/SCAI/SCCT/SIR/SVM/SVS 2012 Appropriate Use Criteria for Peripheral Vascular Ultrasound and Physiological Testing Part I: Arterial Ultrasound and Physiological Testing. Journal of the American College of Cardiology. 2012; Vol 60, No. 3; 242-276.
2. ACR-AIUM-SPR-SRU Practice Parameter for the Performance of Transcranial Doppler Ultrasound. American College of Radiology Amended 2014 (Resolution 39).
3. ACR-AIUM-SRU Practice Parameter for the Performance of an Ultrasound Examination of the Extracranial Cerebrovascular System. American College of Radiology Amended 2014 (Resolution 39).
4. American Board of Surgery
5. Bakri SJ, Luqman A, Pathik B, et al. Is Carotid Ultrasound Necessary in the Clinical Evaluation of the Asymptomatic Hollenhorst Plaque? (An American Ophthalmological Society Thesis). Transactions of the American Ophthalmological Society. 2013;111:17-23.
6. Craven TE, Ryu JE, Espeland MA, et al. Evaluation of the Associations Between Carotid Artery Atherosclerosis and Coronary Artery Stenosis, A Case-Control Study. Circulation. 1990;82:1230-1242.
7. Kallikazaros I, Tsioufis C, Sideris S, et al. Cartoid Artery Disease as a Marker for the Presence of Severe Coronary Artery Disease in Patients Evaluated for Chest Pain. Stroke. 1999;30:1002-1007.
8. Komorovsky R, Desideri A. Carotid ultrasound assessment of patients with coronary artery disease: a useful index for risk stratification. Vascular Health and Risk Management. 2005; 1(2):131-136.
9. von Reutern G-M, Goertler M-W, Bornstein N, et al. Grading Carotid Stenosis Using Ultrasonic Methods. Stroke. 2012;43:916-921.
10. Wijdicks E, Varelas PN, Gronseth GS, et al. Evidence-based guideline update: Determining brain death in adults. Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2010; 74(23): 1911-1918.
11. 2016 NIA Clinical Guidelines for Medical Necessity Review. Magellan Healthcare. 2016; 1-659.