LCD L35092

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 diagnostic abdominal aortography and renal angiography 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 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 diagnostic abdominal aortography and renal angiography 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 6, Section 10 Medical and Other Health Services Furnished to Inpatients of Participating Hospitals, and Section 20.4 Outpatient Diagnostic Services

• Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests

• Chapter 16, Section 20 Services Not Reasonable and Necessary.

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

• Chapter 1, Section 30.2.9 Payment to Physician or Other Supplier for Diagnostic Tests Subject to the Anti-Markup Payment Limitation- Claims Submitted to A/B Macs (B)

• Chapter 3, Section 40.3 Outpatient Services Treated as Inpatient Services

• Chapter 4, Section 20.6 Use of Modifiers

• Chapter 13, Radiology Services and Other Diagnostic Procedures

• Chapter 23, Section 20.9 National Correct Coding Initiative (NCCI)

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

Other:

• National Correct Coding Initiative (NCCI) Coding Policy Manual for Medicare Services, Chapter IX, Radiology Services, Section D: Interventional/Invasive Diagnostic Imaging, Effective January 1, 2018

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(d)(3) indicates diagnostic tests are payable only when ordered by the physician or nonphysician practitioner (NPP) who is treating the beneficiary for a specific medical problem and who uses the results in such treatment.

Indications and Limitations of Coverage

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

According to the 2017 American College of Cardiology (ACC)/American Heart Association (AHA) High Blood Pressure Clinical Practice Guideline1, a blood pressure is considered normal for adults with a systolic blood pressure of less than 120 mm Hg and a diastolic blood pressure of less than 80 mm Hg. Hypertension Stage 2, also known as severe hypertension, is noted to be a systolic blood pressure of greater than or equal to 140 mm Hg or a diastolic blood pressure of greater than or equal to 90 mm Hg. Resistant hypertension is uncontrolled high blood pressure despite the use of at least three different antihypertensive medication classes.

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. The procedures for abdominal aortography or renal arteriography are most commonly done under conscious sedation.

Angiography or arteriography is a medical imaging technique used to visualize the inside, or lumen, or blood vessels and organs of the body, particularly in arteries, veins, and chambers of the heart. This LCD applies the term angiography when referring to abdominal angiography or renal arteriography.

Covered Indications

• Medical Necessity for Abdominal Aortography/Angiography

• Acute traumatic abdominal injury

• Aneurysm and other primary vascular abnormalities

• Occlusive disease, including evaluation for acute or chronic intestinal ischemia

• Acute GI hemorrhage

• Congenital anomaly

• Prior to arterial interventional procedures or open surgical procedures

• Medical Necessity for Stand-Alone Renal Angiography

• Severe or difficult to control renal hypertension

• for severe or difficult to control renal hypertension, OR

• progressive renal insufficiency, OR

• resistant hypertension

• Renal neoplasm

• Hematuria of unknown cause

• Abnormal kidney imaging involving radioisotopes

• Renal artery stenosis, aneurysm, trauma, or other intrinsic defects prior to renal arterial intervention

• Medical Necessity for Lower Extremity or Renal Angiography done at the same time as a different interventional procedure (for example, cardiac catheterization with coronary angiography)

Diagnostic renal angiography or lower extremity angiography performed at the time of an interventional procedure is separately reportable if at least one indication for medical necessity for a stand-alone lower extremity or renal angiography is met AND one of the following are also met:

• No prior catheter-based angiographic study is available and a full diagnostic study is performed, and the decision to intervene is based on the diagnostic study, OR

• A prior study is available, but as documented in the medical record:

• The patient’s condition with respect to the clinical indication has changed since the prior study; OR

• There is inadequate visualization of the anatomy or pathology; OR

• There is a clinical change during the interventional procedure that requires new evaluation outside the target area of intervention.

• Medical necessity for a Stand-Alone Lower Extremity Angiography must be documented by pre-procedure clinical assessment. This assessment should include the following:

• Documentation that an invasive intervention is planned, AND

• Documentation that a prior non-invasive study was completed and indicates further study is needed by angiography for the planned intervention, AND

• Documentation of one of the following conditions: arterial embolism, acute or chronic ischemia, peripheral vascular disease (includes claudication), or aneurysm.

Limitations

LIMITATIONS FOR ABDOMINAL OR RENAL AORTOGRAPHY/ANGIOGRAPHY OR LOWER EXTREMITY ANGIOGRAPHY:

• 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

• Diagnostic angiography performed at a separate session from an interventional procedure may be separately reportable. If a diagnostic angiogram was performed prior to an interventional procedure, a second diagnostic angiogram performed at the time of an interventional procedure is separately reportable when documentation supports it is medically reasonable and necessary to repeat the study to further define the anatomy and pathology. If the prior diagnostic angiogram was performed, a second angiogram (e.g., for the dye injections necessary to perform the interventional procedure) is not separately reportable.

• The localization or guidance is integral to an interventional procedure and is not separately reportable unless CPT instructions specify otherwise.

• In addition to the initial procedure, an appropriate frequency of repeat procedures can 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.

• Medicare would not expect to see a high percentage of femoral or iliac angiography done at the same time of coronary studies and such billing could be subject to review.

• Renal angiography performed at the time of cardiac catheterization in the absence of accepted clinical indication that support medical necessity will be denied as such services are generally not indicated, as mentioned in this LCD.

• Appropriate non-invasive tests should be performed prior to a repeat angiography. 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.

Place of Service (POS)

Angiography services described in this LCD are considered reasonable and necessary when performed in any POS listed below:

• Office

• Off Campus-Outpatient Hospital

• Inpatient Hospital

• On Campus-Outpatient Hospital

• Emergency Room-Hospital

• Ambulatory Surgical Center

Mobile units and all other locations are non-covered.

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. Refer to Billing and Coding: Diagnostic Abdominal Aortography and Renal Angiography, A56682, for applicable CPT codes and diagnosis codes.

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

Summary of Evidence

N/A

Analysis of Evidence

N/A

Associated Information

Refer to the Local Coverage Article: Billing and Coding: Diagnostic Abdominal Aortography and Renal Angiography, A56682, for all coding information.

Documentation Requirements

• All documentation must be maintained in the patient's medical record and be 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 of the patient.

• The medical record documentation must support the medical necessity of the services as stated in this policy.

• The operating physician should retain in the patient's medical records 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 test results.

• Documentation must establish medical necessity and indicate that the treating physician has specifically ordered any angiographic service(s) performed.

• Per 42 CFR Section 410.32, tests not ordered by the physician who is treating the patient are not reasonable and necessary. See 42 CFR Section 410.32, for coverage guidelines.

• The treating physician order for the renal angiography performed at the time of cardiac catheterization must specifically request this extra angiographic service with documentation supporting medical necessity 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

• Whelton PK, Carey RM, Aronow WS et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2017 Nov 13. doi: 10.1161/HYP.0000000000000066. [Epub ahead of print]

• ACR-SIR Practice Guideline for the Performance of Diagnostic Arteriography in Adults. American College of Radiology. Revised 2012 (Resolution 5).

• ACR-SIR-SPR Practice Parameter for Performance of Arteriography. American College of Radiology. Amended 2014 (Resolution 30).

• McCorkell SJ, Harley JD, Morishima MS, et al. Indications for angiography in extremity trauma. AJR Am J Roentgenol. 1985; 145(6): 1245-1247.

• Singh H, Cardella JF, Cole PE, et al. Quality Improvement Guidelines for Diagnostic Arteriography. J Vasc Interv Radiol. 2003; 14:S283–S288. doi 10.1097/01.RVL0000094599.83406.fd

• Understanding Blood Pressure Readings. American Heart Association. Updated Oct 22, 2015. Retrieved from http://www.heart.org/HEARTORG/Conditions/HighBloodPressure/AboutHighBloodPressure/Understanding-Blood-Pressure-Readings_UCM_301764_Article.jsp#.Vj1BnMVOlYc

• Vorgpatanasin W. Resistant Hypertension, A Review of Diagnosis and Management. JAMA. 2014: 311(21); 2216-2224. Doi: 10.1001/jama.2014.5180

• Wein A, Kavoussi LR, Iovick AC, et al. Campbell-Walsh Urology: Elsevier2012; Tenth Edition; p 1063-1083 e7.

• Wenz W. Abdominal Angiography. Springer. Section 5.1. Retrieved from https://books.google.com/books?isbn=3642930255

• World Health Organization. What is raised blood pressure (hypertension)? Online Q&A. Updated September 2015.