Non-Invasive Vascular Studies

LCD Information Document Information Source LCD ID N/A LCD ID L34045 Original ICD-9 LCD ID Not Applicable LCD Title Non-Invasive Vascular Studies Proposed LCD in Comment Period N/A Source Proposed LCD DL34045 Opens in a new window Original Effective Date For services performed on or after 10/01/2015 Revision Effective Date For services performed on or after 11/06/2025 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 02/06/2025 Notice Period End Date 03/22/2025 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. 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Issue Issue Description The revision is based on an LCD reconsideration and supporting literature. Issue - Explanation of Change Between Proposed LCD and Final LCD CMS National Coverage Policy 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).42 CFR, Section 410.33 provides guidelines for independent diagnostic testing facilities (IDTFs) including requirements for technician personnel and supervising physicians.CMS Publications:CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 11: 20.1 Noninvasive Vascular Studies for End Stage Renal Disease (ESRD) Patients CMS Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1: 20.14 Plethysmography 20.17 Noninvasive Tests of Carotid Function 220.5 Ultrasound Diagnostic Procedures 220.11 Thermography CMS Publication 100-08, Medicare Program Integrity Manual, Chapter 13: 13.5 Content of an LCD 13.5.1 Reasonable and Necessary Provisions in LCDs Coverage Indications, Limitations, and/or Medical Necessity Abstract:Non-invasive vascular studies utilize ultrasonic Doppler and physiologic principles to assess irregularities in blood flow in arterial and venous systems. The display may be a two dimensional image with spectral analysis and color flow or a plethysmographic recording. For the purposes of this policy, non-invasive vascular studies include duplex scans, physiologic studies and plethysmography. Definitions: Duplex scan: An ultrasonic scanning procedure with display of both two-dimensional structure and motion with time and Doppler ultrasonic signal documentation with spectrum analysis and/or color flow velocity mapping or imaging. Physiologic studies: Functional measurement procedures that include Doppler ultrasound studies, blood pressure measurements, transcutaneous oxygen tension measurement, or plethysmography. Plethysmography: Plethysmography involves the measurement and recording (by one of several methods) of changes in the size of a body part as modified by the circulation of blood in that part. Plethysmography is of value as a noninvasive technique for diagnostic, preoperative and postoperative evaluation of peripheral artery disease in the internal medicine or vascular surgery practice. It is also a useful tool for the preoperative podiatric evaluation of the diabetic patient or one who has intermittent claudication or other signs or symptoms indicative of peripheral vascular disease which have a bearing on the patient’s candidacy for foot surgery. (CMS Publication 100-03, Medicare National Coverage Decisions Manual, Chapter 1, Section 20.14) 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 stenosis 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. This local coverage determination specifies CGS policy for non-invasive vascular study testing. INDICATIONS AND LIMITATIONS: General Indications:Non-invasive vascular studies are considered medically necessary if the ordering physician has reasonable expectation that their outcomes will potentially impact the clinical management of the patient. Services are deemed medically necessary when the following conditions are met: Significant signs/symptoms of arterial or venous disease are present; The information is necessary for appropriate medical and/or surgical management; and/or The test is not redundant of other diagnostic procedures that must be performed. In general, non-invasive studies of the arterial system are utilized when invasive correction is contemplated. It is the responsibility of the physician/provider to ensure the medical necessity of procedures and documentation of such in the medical record. Credentialing and Accreditation StandardsThe 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 and maintain any applicable documentation. A vascular diagnostic study may be personally performed by a physician or a technologist.The GAO Report to Congressional Committees entitled Medicare Ultrasound Procedures. Consideration of Payment Reforms and Technician Qualifications Requirements states that “Findings from several peer-reviewed studies, the Medicare Payment Advisory Commission, and ultrasound-related professional organizations support requiring that sonographers either have credentials or operate in facilities that are accredited, where specific quality standards apply. In some localities and practice settings, CMS or its contractors have required that sonographers either be credentialed or work in an accredited facility.” (GAO-07-734)For areas under CGS Administrators, LLC jurisdiction the requirements will be effective for all providers 30 April 2011: All non-invasive vascular diagnostic studies must be performed under at least one of the following settings: (1) performed by a physician who is competent in diagnostic vascular studies or under the general supervision of physicians who have demonstrated minimum entry level competency by being credentialed in vascular technology, or (2) performed by a technician who is certified in vascular technology, or (3) performed in facilities with laboratories accredited in vascular technology. Examples of appropriate personnel certification include, but are not limited to the Registered Physician in Vascular Interpretation (RPVI), Registered Vascular Technologist (RVT), the Registered Cardiovascular Technologist (RCVT), Registered Vascular Specialist (RVS), and the American Registry of Radiologic Technologists (ARRT) credentials in vascular sonography. Appropriate laboratory accreditation includes the American College of Radiology (ACR) Vascular Ultrasound Program, and the Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL). Additionally, transcutaneous oxygen tension measurements may be performed by individuals possessing the following credentials obtained from the National Board of Diving and Hyperbaric Medicine Technology (NBDHMT): Certified Hyperbaric Technologist (CHT), or Certified Hyperbaric Registered Nurse (CHRN). Asymptomatic or symptomatic cervical bruits; Amaurosis fugax; Focal cerebral or ocular transient ischemic attacks (including but not limited to): localizing symptoms, e.g., sensory loss; and/or weakness of one side of the face; and/or slurred speech; and/or weakness of a limb; Syncope that is strongly suggestive of vertebrobasilar or bilateral carotid artery disease in etiology, as suggested by medical history; Recent history of a previous neurologic or cerebrovascular event; Before major cardiac and vascular surgery when a bruit is noted or there is a history of previous neurologic or cerebrovascular event; After carotid endarterectomy (outside the global period), or follow-up of previously documented stenoses; Pulsatile neck mass; Evaluation of blunt or penetrating neck trauma; Ocular microembolism (optic nerve/retinal arterial-Hollenhorst plaques/ocular); Arterial Fibromuscular dysplasia Limitations: Studies may not be considered medically necessary if performed for the following signs and symptoms: Drop attack or syncope are rare indications usually seen with vertebrobasilar or bilateral carotid artery disease. Dizziness is not a typical indication unless associated with other localizing signs or symptoms. However, episodic dizziness with symptom characteristics typical of transient ischemic attacks may indicate medical necessity, especially when other more common sources, e.g., postural hypotension or transiently decreased cardiac output as demonstrated by cardiac event monitoring, have been previously excluded; and/or Headaches (including migraines). Duplex ultrasonography has gained an acceptable role in the diagnosis and management of fibromuscular dysplasia. An international consensus document on the diagnosis and management of fibromuscular dysplasia states the first step to confirm clinical suspicion of renal FMD is non-invasive imaging with CTA as the initial test preferred and MRA if CTA is contraindicated. (Gornik 2019) A European consensus document on the diagnosis and management of fibromuscular dysplasia recommends noninvasive studies in the following scenarios(Persu 2014): Duplex ultrasound should be first-line screening test to detect RAS and confirmed by another imaging technique if positive result or if negative result accompanied by high clinical suspicion. MR-angiography or CT-angiography are considered first line tests and should be used to confirm diagnosis of renal artery FMD in the following cases Results of DUS are suboptimal Degree of suspicion of FMD is high and/or FMD diagnosis would have major clinical implications. The American Heart Association published a statement acknowledging the role noninvasive imaging studies such as duplex ultrasonography, CTA, and MRA, with the gold standard as catheter-based angiography as a diagnostic path for renal FMD. (Olin 2014) Detection and evaluation of the hemodynamic effects of severe stenosis or occlusion of the 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 complicating subarachnoid hemorrhage; Evaluation of intracranial hemodynamic abnormalities in patients with suspected brain death; Intraoperative and perioperative monitoring of intracranial flow velocity and hemodynamic patterns during carotid endarterectomy, (although the professional component could only be reimbursed if it is provided during the operative procedure by a physician that is not a member of the operating team); Evaluation of cerebral embolization; and/or Assessing hemodynamic effects, patterns, and extent of collateral circulation in patients with known regions of severe stenosis or occlusion when necessary to care for the patient; and Assessing stroke risk in children aged two to sixteen with homozygous sickle cell disease; and As an alternative to an echocardiogram to detect residual right to left shunting after repair/closure of an intracardiac or intrapulmonary shunt. Multiple cerebrovascular procedures may be allowed during the same encounter given the physician/provider can demonstrate medical necessity as documented in the patient’s medical record. For example, physiologic studies and a duplex scan are allowed on the same date of service given the provider is able to document medical necessity, e.g., greater than or equal to 50% stenosis on duplex scan or significant symptoms as demonstrated by the indications for the study. Limitations:TCD studies are not indicated 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; and/or Epilepsy. Transcranial Doppler (TCD) is considered investigational and not medically necessary for the following indications: Assessing patients with migraine; Monitoring during cardiopulmonary bypass and other cerebrovascular and cardiovascular interventions, and surgical procedures (except during carotid endarterectomy, as noted above); Evaluation of patients with dilated vasculopathies such as fusiform aneurysms; Assessing autoregulation, physiologic, and pharmacological responses of cerebral arteries; and/or Evaluating children with various vasculopathies, such as moyamoya disease and neurofibromatosis. Claudication of such severity that it interferes significantly with the patient’s occupation or lifestyle, or claudication with inability to stress the patient; Rest pain (typically including the forefoot), usually associated with absent pulses, which becomes increasingly severe with elevation and diminishes with placement of the leg in a dependent position; Tissue loss defined as gangrene or pre-gangrenous changes of the extremity, or ischemic ulceration of the extremity occurring in the absence of pulses; Aneurysmal disease; Evidence of thromboembolic events; Blunt or penetrating trauma (including complications of diagnostic and/or therapeutic procedures); and/or Follow-up of grafts or other vascular intervention Pre-surgical conduit assessment of the upper extremity/radial artery(ies) may be performed prior to use in coronary artery bypass grafting (CABG) or as other arterial conduits. Limitations:Peripheral artery studies may not be considered medically necessary if only the following signs and symptoms are present: Continuous burning of the feet (considered to be a neurologic symptom); Leg pain, nonspecific (M79.606) and pain in limb (M79.669) as single diagnoses are too general to warrant further investigation unless they can be related to other signs and symptoms; Edema rarely occurs with arterial occlusive disease unless it is in the immediate postoperative period, in association with another inflammatory process or in association with rest pain; and/or Absence of pulses in minor arteries, e.g., dorsalis pedis or posterior tibial, in the absence of symptoms. The absence of pulses is not an indication to proceed beyond the physical examination unless it is related to other signs and/or symptoms. Clinical signs and/or symptoms of DVT including, but not limited to, edema, tenderness, inflammation, and/or erythema; Clinical signs and/or symptoms of pulmonary embolus (PE) including, but not limited to, hemoptysis, chest pain, and/or dyspnea; Unexplained lower extremity edema status, post major surgical procedures, trauma, other or progessive illness/condition; and/or Unexplained lower extremity pain, excluding pain of skeletal origin. These studies are rarely considered medically necessary for the following: Bilateral limb edema in the presence of signs and/or symptoms of congestive heart failure, exogenous obesity and/or arthritis; and/or Follow-up of phlebitis unless signs/symptoms suggest possible extension of thrombus. Chronic Venous InsufficiencyChronic venous insufficiency may be divided into three categories: primary varicose veins, recurrent DVT, and post-thrombotic (post-phlebitic) syndrome. Peripheral venous studies may be indicated for the evaluation of: Venous function in patients with ulceration suspected to be secondary to venous insufficiency when documenting venous valvular incompetence prior to invasive therapeutic intervention; Varicose veins by themselves do not indicate medical necessity, but medical necessity may be indicated when they are accompanied by significant pain or stasis dermatitis; and/or Superficial thrombophlebitis involving the proximal thigh (to investigate whether there was thrombus at the saphenofemoral junction that would demand either anticoagulation or surgical ligation). Vein MappingMapping the saphenous veins prior to scheduled revascularization procedures is covered by Medicare when it is expected that an autologous vein will be used, but only if there is uncertainty regarding the availability of a suitable vein for by-pass. Vein mapping is not always necessary as a routine pre-operative study but is medically reasonable when the patient’s clinical evaluation indicates one of the following: Previous partial harvest of the vein; Previous thrombophlebitis or DVT in the leg; Severe varicose veins; Previous history of vein stripping, ligation, or sclerotherapy; Obesity to the degree it interferes with clinical determination; Elevated venous pressure > 200mm Hg on a 200 cc/min. pump; Elevated recirculation of time of 12% or greater, and Low urea reduction rate < 60% An access with a palpable "water hammer" pulse on examination (which implies venous outflow obstruction) An example of a clinical situation demonstrating the need for both studies would be a scenario where a Doppler flow study demonstrates reduced flow (blood flow rate less than 800 cc/min or a decreased flow of 25% or greater from previous study), and the physician requires an arteriogram, to define the extent of the problem. The patient's medical record(s) must provide documentation supporting the need for more than one imaging study. Summary of Evidence N/A Analysis of Evidence (Rationale for Determination) The policy coverage has been expanded to include Arterial Fibromuscular dysplasia based on new literature and societal input outlining role of non-invasive testing for this condition. Summary of change: Expand coverage to Arterial Fibromuscular dysplasia