LCD L35035

Coverage Guidance

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for thoracic aortography and carotid, vertebral, and subclavian angiography. 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 thoracic aortography and carotid, vertebral, and subclavian angiography 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 Covered Medical and Other Health Services, 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 20.7 Percutaneous Transluminal Angioplasty (PTA)

• Chapter 1, Part 4, Section 220.9 Digital Subtraction Angiography (DSA)

• CMS IOM Publication 100-04, Medicare Claims Processing Manual,

• Chapter 12 Physicians/Nonphysican Practitioners, Section 100.1.5 Other Complex or High Risk Procedures

• Chapter 13 Radiology Services and Other Diagnostic Procedures, Section 40.1 Magnetic Resonance Angiography (MRA)

• Chapter 23 Fee Schedule Administration and Coding Requirements, Section 20.9 National Correct Coding Initiative (NCCI)

• NCCI Coding Policy Manual for Medicare Services

• Chapter V Surgery: Respiratory, Cardiovascular, Hemic and Lymphatic Systems, Section D Cardiovascular System

• Chapter IX Radiology Services, Section D: Interventional/Invasive Diagnostic Imaging

• CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13 Local Coverage Determinations, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

• 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.

• 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.

Federal Register References:

• Title 42 Code of Federal Regulations (CFR) section 410.32 Diagnostic x-ray tests, diagnostic laboratory tests and other diagnostic tests: Conditions-documentation requirements for clinical review.

Indications and Limitations of Coverage

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

Angiography is a medical imaging technique used to visualize the inside of the lumen, blood vessels, organs of the body, particularly in arteries, veins, and chambers of the heart. During an angiography procedure, blood vessels (arteries or veins) are injected with a dye that shows up on an X-ray. The procedure may be only for diagnostic purposes at which time only X-ray images of the blood vessels are obtained; or the procedure may include treatment. The former procedure is called 'diagnostic angiography' and the latter 'interventional angiography'.

When an artery is injected, it is called arteriography and venography when a vein is injected. Most commonly the arteries are investigated and only occasionally the veins. Diagnostic arteriography is an invasive procedure for the purpose of evaluating vascular disease. The process involves passing a needle or catheter through the skin under fluoroscopic guidance into an artery followed by injection of contrast material and imaging of the vascular area in question using digital imaging or serial film imaging.

Carotid angiography involves the study of the carotid and cerebral vessels. Thoracic aortography involves the study of the aorta in the chest. The thoracic arch of the aorta has three branches: the brachiocephalic artery (also known as the innominate artery which divides into right common carotid artery and the right subclavian artery), the left common carotid artery, and the left subclavian artery. These arteries provide blood to both arms and the head. The vertebral arteries arise from the subclavian arteries, ascend in the neck and merge to form the single midline basilar artery which supplies the posterior fossa and occipital lobes as well as provides segmental vertebral and spinal column blood supply.

Covered Indications

Contrast angiography is considered medically reasonable and necessary and recognized as the gold standard for defining any of the following:

• The presence/extent of vascular occlusive disease and thromboembolic phenomena;

• Etiology of hemorrhage;

• Vascular supply of tumors;

• Outlining vascular anatomy for planning and determining the effect of therapeutic procedures;

• The presence, location, and anatomy of extracranial and intracranial aneurysms and vascular malformations;

• The diagnosis of the nature and extent of congenital or acquired vascular abnormality;

and

• The relevant vascular anatomy for determining the effect of therapeutic measures.

Candidates for these procedures should meet at least one of the following criteria:

• Documented symptoms of ischemic cerebral disease;

• Documented results from previous noninvasive test(s) indicating severely stenotic carotid disease or severely ulcerated carotid disease;

• Medical history consistent with known or suspected trauma, tumor or other intracranial anomalies;

• Medical history consistent with upper extremity claudication, acute or chronic arterial trauma, thoracic outlet obstruction disease, certain vasculitides, and subclavian steal;

• Surgical or percutaneous correction of the occlusive disease must be beneficial to the candidate’s clinical status.

Limitations

• Radiological imaging should adhere to the standards established by the American College of Radiology (ACR), the Society of Interventional Radiology (SIR), American College of Cardiology, or Society of Vascular Surgeons.

• There are no absolute contraindications to diagnostic aortography/angiography. Relative contraindications include but are not limited to:

• Severe hypertension

• Uncorrectable coagulopathy or thrombocytopenia

• Clinically significant sensitivity to iodinated contrast material

• Renal insufficiency based on the estimated glomerular filtration rate (eGFR)

• Congestive heart failure

• Certain connective tissue disorders which may indicate increased risk for complications at the puncture site

• Equipment - Per ACR Practice Parameter for the performance of arteriography (Amended 2014, Resolution 39), the equipment used in the performance of the study should include at a minimum “a high-resolution flat-panel detector or image intensifier and television chain with standard arteriographic filming capabilities, including large-format image intensifiers (14-inch or greater) with minimum 1,024-image matrix. Digital angiographic systems are strongly recommended, as they allow for reduced volumes of contrast material, reduced examination times, and reduction of radiation dose. Features such as last image hold, pulsed fluoroscopy, and road mapping capabilities are strongly recommended for dose reduction. Imaging and image recording must be consistent with the as low as reasonably achievable (ALARA) radiation safety guidelines. Appropriate shielding for the operator should be available on all angiographic systems. The use of cineradiography or small-field mobile image intensifiers is inappropriate for the routine recording of noncoronary angiography; because they cause an unacceptably high patient and operator radiation dose. The equipment should be capable of recording the radiation dose received by the patient so it can be made part of the patient’s permanent medical record.” Images should be stored either on conventional film or digitally on electronic storage media.

• If a diagnostic angiogram (fluoroscopic or computed tomographic) was performed prior to the date of the percutaneous intravascular interventional procedure, it would not be expected that a second diagnostic angiogram would routinely be performed on the date of the percutaneous intravascular interventional procedure. If a second diagnostic angiogram is reported, documentation must support the medical necessity to repeat the study and be made available upon request. Frequent reporting of a second diagnostic angiogram may trigger focused medical reviews.

• Diagnostic studies of the cervicocerebral arteries include angiography of the thoracic aortic arch. Therefore, it would not be expected that thoracic aortography would routinely be reported at the time of diagnostic studies of the cervicocerebral arteries. Please refer to Local Coverage Article: Billing and Coding: Thoracic Aortography and Carotid, Vertebral, and Subclavian Angiography (A56631), for all coding information. If these services are reported together, documentation must support the medical necessity of this extra angiographic service to additionally examine the descending thoracic aorta and be made available upon request. Frequent reporting of these services together may trigger focused medical reviews.

• Contrast injections for localization and/or guidance during interventional procedures, are considered integral to the procedure. Providers should refer to the applicable Current Procedural Terminology (CPT) Manual to assist with proper reporting of these procedures.

• In addition to the initial procedure, an appropriate frequency of repeat procedures may be allowed as long as medical necessity is clearly established and documented. It is expected that important diagnostic information will be obtained from the angiography, which will assist in patient management and treatment. Repeat angiography may be medically reasonable and necessary if there is documentation of new and incapacitating symptoms.

• Appropriate non-invasive tests should be performed prior to a repeat angiography unless there are urgent circumstances. A trial of or a change in medical management would be expected prior to repeat angiography unless the patient is deemed unstable and in need of some type of surgical intervention. Documentation must support the medical necessity of a repeat angiography and be made available upon request.

Place of Service (POS)

These services may be performed in a hospital, a hospital outpatient area, office, ambulatory surgery center, independent diagnostic testing facility (IDTF), or an independent catheterization laboratory demonstrating the appropriate equipment and personnel.

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 the related billing and coding article, A53252 for additional information.

Provider Qualifications

Diagnostic arteriography examinations must be performed under the personal supervision of and interpreted by a qualified physician as follows:

• Personal Supervision - Please refer to the CMS manuals listed under the IOM Citations and the Federal Register sections above for complete coverage information related to personal supervision.

• Qualified Physicians - who perform diagnostic invasive vascular procedures must possess the knowledge, skills, training and experience necessary to properly select suitable patients, perform the procedures safely, and recognize and handle complications. Practitioners who perform and report these services for Medicare payment must have satisfied training and competency guidelines acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty in the United States (i.e. in peripheral vascular medicine and intervention as part of a formal postgraduate training program in radiology, cardiology or general/vascular surgery). Alternatively, qualified physicians must have successfully completed equivalent supervised 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 (i.e. in vascular medicine and intervention as published by a recognized specialty organization of the same stature as the American College of Radiology, American College of Cardiology, American College of Surgeons, or Society of Interventional Radiology). Documented formal training in the performance of invasive catheter angiographic procedures must be included and made available upon request.

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.

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

Summary of Evidence

Please refer to the “History/Background and/or General Information” section for general information on these services.

National Associations such as the American College of Radiology (ACR), the American Society of Neuroradiology (ASNR), the Society of Neuro-Interventional Surgery (SNIS), the Society of Interventional Radiology (SIR), and Society for Pediatric Radiology (SPR) publish practice guidelines on various subjects related to these services. Some guidelines may be specifically focused on an anatomical area, such as cervicocerebral studies. These guidelines are not legally binding, but outline a reasonable approach and needs to provide safe services, with appropriately qualified providers, staff and needed equipment. The practice guidelines are as follows:

• ACR-SIR-SPR Practice Parameter for Performance of Arteriography from 2017. This is an educational tool for studies not including coronary arteriography and cervicocerebral circulation. It outlines indications, personnel training and competency, equipment needed, and the pre and post evaluation and monitoring care.

Although this is not a graded parameter, it is felt to be strong as the parameter was created and promoted by the providers who do these studies under the umbrella of multiple national societies and colleges as a collaborative effort.

Quality of Evidence: Not Graded

• ACR-ASNR-SIR-SNIS Practice Parameter for the Performance of Diagnostic Cervicocerebral Catheter Angiography from 2016. This parameter’s important elements include: patient selection/preparation/and education; indications and contraindications, expertise in performing and interpreting the procedure; and monitoring of the patients.

Although this is not a graded parameter, it is felt to be strong as the parameter was created and promoted by the providers who do these studies under the umbrella of multiple national societies and colleges as a collaborative effort.

Quality of Evidence: Not Graded

• ACR-SIR-SNIS- SPR Practice Parameter for Interventional Clinical Practice and Management from 2014. This practice parameter was developed, written, and revised collaboratively by the American College of Radiology (ACR), the Society of Interventional Radiology (SIR), the Society of Neurointerventional Surgery (SNIS), and the Society for Pediatric Radiology (SPR). Recommendations outline ‘The Clinical Team’, Imaging Requirements, Radiation Safety Imaging for Interventional Studies and equipment needs. It is felt these parameters would apply to diagnostic studies as well as any interventions that may follow.

Although this is not a graded parameter, it is felt to be strong as they are created and promoted by the providers who do these services under the umbrella of multiple national societies and colleges in a collaborative effort.

Quality of Evidence: Not Graded

Analysis of Evidence

Data analysis and Annual Review of an existing LCD necessitated several coding/coverage changes to provide a more limited focus, including: the removal of lower extremity codes (as they were addressed in LCD L35092 Diagnostic Abdominal Aortography and Renal Angiography); the removal of unspecified laterality codes where right, left and bilateral codes were available; the removal of unspecified anatomical sites when more specific sites were available which appear to cover all sites needed; the narrowing of focus to procedure codes specific to the policy intent, i.e. removal of more generic CPT codes that would be used in other studies for vascular access; removal of dialysis access diagnoses and codes brought into the LCD based on the generic vascular access codes; and removal of diagnoses pertaining to the arm past the shoulder as they were not in the intent of the LCD.

Practice Guidelines were used for general information as best practices for indications, provider training, support personnel training, equipment needed for appropriate and safe studies.

Associated Information

Please refer to the Local Coverage Article: Billing and Coding: Thoracic Aortography and Carotid, Vertebral, and Subclavian Angiography, A56631, for all coding information.

Documentation Requirements

• All documentation must be maintained in the patient's medical record and made available to the contractor upon request.

• 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.

• Documentation must be evident in the patient's medical record to substantiate the medical necessity of the testing performed.

• The operating physician should retain in the patient’s medical record the history and physical examination and notes documenting the evaluation and management of one of the Medicare covered conditions/diagnoses, including relevant clinical signs/symptoms or abnormal diagnostic tests results. Medical records must be available upon request.

• If a diagnostic angiogram (fluoroscopic or computed tomographic) was performed prior to the date of a percutaneous intravascular interventional procedure, and a second diagnostic angiogram is reported on the date of the percutaneous intravascular interventional procedure, documentation must support the medical necessity to repeat the study and be made available upon request.

• The treating physician order for the thoracic aortography performed at the time of diagnostic studies of the cervicocerebral arteries must specifically request this extra angiographic service with documentation supporting medical necessity to additionally examine the descending thoracic aorta and be made available upon request.

Utilization Guidelines

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

Bibliography

• ACR–ASNR–SIR–SNIS Practice Parameter for the Performance of Diagnostic Cervicocerebral Catheter Angiography in Adults. American College of Radiology. Revised 2016 (Resolution 13).

• ACR-SIR-SNIS-SPR Practice Parameter for Interventional Clinical Practice and Management. American College of Radiology. Amended 2014 (Resolution 18).

• ACR-SIR-SPR Practice Parameter for Performance of Arteriography. American College of Radiology. Amended 2017 (Resolution 14).

• Citron SJ, Wallace RC, Lewis CA, et al. Quality Improvement Guidelines for Adult Diagnostic Neuroangiography Cooperative Study between ASITN, ASNR, and SIR. JVIR. 2003;14:S257-S262.

• Dariushnia SR, Gill AE, Martin LG, et al. Quality Improvement Guidelines for Diagnostic Arteriography. JVIR. 2014;25(12):1873-1881.

• Diagnostic and Interventional Angiography. YourSurgery.Com. Last accessed 03/10/2017 at http://www.yoursurgery.com/ProcedureDetails.cfm?BR=2&Proc=70

• Gaillard F, et al. Vertebral artery. Last accessed 03/23/2017 at https://radiopaedia.org/articles/vertebral-artery

• Wojak JC, Abruzzo TA, Bello JA, et al. Quality Improvement Guidelines for Adult Diagnostic Cervicocerebral Angiography: Update Cooperative Study between the Society of Interventional Radiology (SIR), American Society of Neuroradiology (ASNR), and Society of NeuroInterventional Surgery (SNIS). J Vasc Interv Radiol. 2015 Nov;26(11):1596-608.