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

Transcription

1 National Imaging Associates, Inc. Clinical guidelines NON-INVASIVE CEREBROVASCULAR ARTERIALS TUDIES Original Date: October 2015 Page 1 of 8 FOR CMS (MEDICARE) MEMBERS ONLY CPT4 Codes: Please refer to page 6-7 Last Effective Date: January 2017 LCD ID Number: L35397 J H = AR, CO, LA, MS, NM, OK, TX J L = PA, NJ, MD, DE, DC Responsible Department: Clinical Operations Last Revised Date: May 2017 Implementation Date: May 2017 FOR CMS (MEDICARE) MEMBERS ONLY 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 2016 CPT book, page 626). 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. 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 1 Non-Invasive Cerebrovascular Arterial Studies - CMS

2 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 (CPT codes and 93882) 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 (CPT codes 93886, 93888, 93890, 93892, and 93893) 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 Local Coverage Article A52992 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 (CPT codes and 93882): o Evaluation of patients with a cervical bruit o Evaluation of pulsatile neck masses o Evaluation of patients with hemispheric neurologic symptoms, including stroke, transient ischemic attack and amaurosis fugax o Follow-up of patients with proven carotid disease who are receiving medical therapy o Follow-up for postoperative patients following carotid endarterectomy, stenting or carotid to subclavian bypass o Evaluation of suspected subclavian steal syndrome o Evaluation of retinal arterial emboli o Evaluation of suspected carotid artery dissection or pseudoaneurysm o Evaluation of sudden and lateralizing neurologic deficit o Established or symptomatic coronary artery disease or cardiac valvular disease o "Drop attacks" or syncope when there are documented signs or symptoms consistent with vertebral basilar or carotid artery disease or insufficiency 2 Non-Invasive Cerebrovascular Arterial Studies - CMS

3 2. The following are covered indications for Transcranial Doppler (TCD) (CPT codes 93886, 93888, 93890, and 93893): o Detection and follow up of severe stenosis in the major basal intracranial arteries o Assessment of patterns and extent of collateral circulation in patients with known regions of severe cerebral stenosis or occlusion o Intraoperative and perioperative monitoring of intracranial flow velocity and hemodynamic patterns during carotid endarterectomy o Detection and monitoring of vasospasm in patients with spontaneous or traumatic subarachnoid hemorrhage o Detection and follow up of cerebral arteriovenous malformations o Confirmation of the clinical diagnosis of brain death o Evaluation of invasive therapeutic interventions for cerebral malformations o Evaluation of cerebral embolization o "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: o 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. o 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 noninvasive 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 (CPT codes 93886, 93888, 93890, and 93893) including but not limited to the following conditions are not covered: o Evaluation of brain tumors o Assessment of familial and degenerative diseases of the cerebrum, brainstem, cerebellum, basal ganglia and motor neurons o Evaluation of infectious and inflammatory conditions o Evaluation of psychiatric disorders o Epilepsy o Assessing patients with migraine or headache o Monitoring during cardiopulmonary bypass and other cerebrovascular and cardiovascular interventions, and other surgical procedures 3 Non-Invasive Cerebrovascular Arterial Studies - CMS

4 o Evaluation of patients with dilated vasculopathies such as fusiform aneurysms o Assessing autoregulation, physiologic, and pharmacological responses of cerebral arteries o Evaluating various vasculopathies such as sickle cell disease, moya moya disease, and neurofibromatosis 4. The following methods are not acceptable for reimbursement of CPT codes 93880, 93882, 93886, 93888, 93890, 93892, and 93893: o Thermography o Mechanical oscillometry o Inductance plethysmography o Capitance plethysmography o Photoelectric plethysmography o Light reflection rheography o Pulse Delay Oculoplethysmography o Carotid Phonoangiography and other forms of bruit analysis are included in the reimbursement for the office visit o Periorbital Photoplethysmography 5. The following limitations apply to multiple non-invasive studies performed during the same encounter: o Performance of both non-invasive extracranial arterial studies (CPT codes or 93882) and non-invasive evaluation of extremity veins (CPT codes or 93971) 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. o 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 2016 CPT book, page 626) Doppler procedures performed with zero-crossers (i.e., analog [strip chart recorder] analysis) are also included in any 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 4 Non-Invasive Cerebrovascular Arterial Studies - CMS

5 performed by appropriately trained personnel. 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. General Supervision means the procedure is furnished under the physician's overall direction and control, but the physician's presence is not required during the performance of the procedure. Under General Supervision, the training of the non-physician personnel who actually performs the diagnostic procedure and the maintenance of the necessary equipment and supplies are the continuing responsibility of the physician. 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. 5 Non-Invasive Cerebrovascular Arterial Studies - CMS

6 Notice: This LCD imposes frequency limitations as well as diagnosis limitations that support diagnosis to procedure code automated denials. However, 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. For frequency limitations please refer to the Utilization Guidelines section below. As published in CMS IOM , Chapter 13, Section , in order to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is: Safe and effective. Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000 that meet the requirements of the Clinical Trials NCD are considered reasonable and necessary). Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is: o Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member. o Furnished in a setting appropriate to the patient's medical needs and condition. o Ordered and furnished by qualified personnel. o One that meets, but does not exceed, the patient's medical needs. o At least as beneficial as an existing and available medically appropriate alternative. The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD. CPT/HCPCS Codes Group 1 Paragraph: Note: Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. Group 1 Codes: Extracranial bilat study Extracranial uni/ltd study 6 Non-Invasive Cerebrovascular Arterial Studies - CMS

7 Group 2 Paragraph: N/A Group 2 Codes: Intracranial complete study Intracranial limited study Tcd vasoreactivity study Tcd emboli detect w/o inj Tcd emboli detect w/inj Please refer to the CMS website for the ICD-10 Codes that Support Medical Necessity. Documentation Reuirements 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 submitted medical record should support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code should describe the service performed. 4. The medical record documentation must support the medical necessity of the services as directed in this policy. 5. 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. 6. The medical record must contain any pertinent prior diagnostic testing and completed report(s). 7. The medical necessity for performing both non-invasive extracranial arterial studies (CPT codes or 93882) and non-invasive evaluation of extremity veins (CPT codes or 93971) during the same encounter must be clearly documented in the medical record. 8. 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: 7 Non-Invasive Cerebrovascular Arterial Studies - CMS

8 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 CPT codes and 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. 8 Non-Invasive Cerebrovascular Arterial Studies - CMS