Non-Invasive Abdominal / Visceral Vascular Studies

Title XVIII of the Social Security Act section 1833 (e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Title XVIII of the Social Security Act section 1862 (a) (1) (A) allows coverage and payment of those items or services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act section 1862 (a) (1) (D) excludes Medicare payment for any expenses incurred for items or services that are investigational or experimental.

Title XVIII of the Social Security Act section 1862 (a) (7) excludes routine physical examinations and services from Medicare coverage.

42 CFR, Section 410.32 Diagnosis x-ray tests, diagnostic laboratory tests, and other diagnostic 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) who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem. Tests not ordered by the physician or other qualified non-physician provider who is treating the patient are not reasonable and necessary (42 CFR 411.15(k) (1).

42 CFR, Section 410.32 (b) Diagnostic x-ray and other diagnostic tests. (1) Basic rule … all diagnostic x-ray and other diagnostic tests covered under section 1861(s)(3) of the Act and payable under the physician fee schedule must be furnished under the appropriate level of supervision by a physician as defined in section 1861® of the Act. Services furnished without the required level of supervision are not reasonable and necessary. (see 42 CFR 411.15(k)(1)).

CMS Pub 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 Pub 100-03 Medicare National Coverage Determinations (NCD) Manual - Chapter 1 – Coverage Determinations
Part 4 Section 220.5 - Ultrasound Diagnostic Procedures

CMS Pub 100-04 Medicare Claims Processing Manual, Chapter 13 – Radiology Services and Other Diagnostic Procedures, Sections –
10.1 Billing Part B Radiology Services and Other Diagnostic Procedures and
20 – Payment Conditions for Radiology Services,
Chapter 16 – Laboratory Services, Section
40.2 – Payment Limit for Purchased Services.

CMS Pub 100-08, Medicare Program Integrity Manual, Chapter 13 – Local Coverage Determinations, Section 13.5.1 – Reasonable and Necessary Provisions in LCDs.

CMS Publication 100-09, Medicare Contractor Beneficiary and Provider Communications Manual, Chapter 5 - Correct Coding Initiative.

Overview
Non-invasive abdominal/visceral vascular studies utilize ultrasonic Doppler and physiologic principles to assess the irregularities in blood flow in renal, iliac, and femoral artery systems. These tests are also used to diagnose aortic aneurysms. Noninvasive abdominal/ visceral vascular studies include the patient care required to perform the studies, supervision of the studies, and interpretation of study results, with copies for patient records of test results and analysis of all data, including bi-directional vascular flow or imaging when provided.

Diagnostic tests must be ordered by the physician who is treating the beneficiary and who will use the results in the management of the beneficiary’s specific medical problem. Services are deemed medically necessary when all of the following conditions are met:

1. Signs/symptoms of ischemia or altered blood flow are present;
2. The information is necessary for appropriate medical and/or surgical management;
3. The test is not redundant of other diagnostic procedures that must be performed. Although, in some circumstances, non-invasive vascular tests are complimentary, such as MRA and duplex, where the latter may confirm an indeterminate finding or demonstrate the physiologic significance of an anatomic stenosis such as in renal, iliac, and/or femoral arteries.

Definitions:
Duplex Scans: Duplex combines Doppler and conventional ultrasound, allowing the structure of blood vessels, how the blood is flowing through the vessels, and whether there is any obstruction in the vessels to be seen. Color Doppler produces a picture of the blood vessel, and a computer converts the Doppler sounds into colors overlaid on the image, representing information about the speed and direction of blood flow. Using spectral Doppler analysis, the duplex scan images provide anatomic and hemodynamic information, identifying the presence of any stenosis or plaque in the arteries. Duplex scans are in real-time.

I. Abdominal/Visceral Vascular Studies
Abdominal/visceral non-invasive vascular studies are indicated in the evaluation and /or management of vascular disease along with, the narrowing or blockage of arteries that supply blood to the abdomen including intestines (mesenteric vascular disease), pelvic and scrotal contents, and/or retroperitoneal organs including the kidneys (renal vascular disease).

A. Abdominal, Retroperitoneal and Pelvic Organs 
Indications:

1. Uncontrolled hypertension.
2. Stenosis of visceral artery (atherosclerotic, fibromuscular dysplasia, vasculitis, functional).
3. Aneurysm of visceral artery.
4. Portal hypertension, with or without ascites.
5. Cirrhosis of the liver.
6. Venous embolism, hemorrhage, infection, and/or thrombosis of visceral vein (renal,
hepatic, mesenteric, portal or splenic).
7. Stenosis of visceral vein (renal, hepatic, mesenteric, portal or splenic).
8. Complications of internal (biological) (synthetic) prosthetic device implant and/or graft.
9. Complications in abdominal organ or tissue transplant.
10. Pain or swelling of scrotal contents which may be a result of suspected obstruction in
arterial inflow or venous outflow to testicles or related structure.
11. Torsion of the spermatic cord; acute epididymitis or epididymoorchitis; or torsion of the
testicular appendages.
12. Hypertension and normotensive renovascular disease with impaired renal function
which could be acute kidney failure, chronic kidney disease, end stage renal disease, or
other vascular disorders of the kidneys.
13. Pain or swelling of the female genital organs which may be the result of torsion of the
ovaries, ovarian pedicle, or fallopian tube.
14. Trauma to the abdominal, retroperitoneal and/or pelvic organs, arteries, and /or veins.

B. Aorta, Inferior vena cava, Iliac Vasculature and Bypass grafts 
Indications:

1. Atherosclerosis of aorta.
2. Atherosclerosis of the extremities with intermittent claudication.
3. Atherosclerosis of other specified arteries.
4. Aortic aneurysm and dissection.
5. Aneurysm of iliac artery.
6. Thromboangiitis obliterans (Buerger’s disease).
7. Peripheral vascular disease unspecified.
8. Arterial embolism and thrombosis of abdominal aorta.
9. Arterial embolism and thrombosis of iliac artery.
10. Phlebitis and thrombophlebitis of iliac vein.
11. Venous embolism and thrombosis of vena cava.
12. Complications related to surgical procedures involving prosthetic device implant, graft, and/or shunts.
13. Complications of organ or tissue transplant.
14. Trauma to the chest wall and /or abdomen resulting in a possible injury to the aorta, inferior vena cava and/or iliac vasculature.

Limitations:

1. Vascular studies are not the initial diagnostic modality for the evaluation of abdominal pain/tenderness. There must be a high index of suspicion that the pain is caused by a vascular disorder, such as mesentery ischemia.
2. Routine imaging of the iliac veins is not medically necessary. Exceptions will be made for specific medical indications of possible propagation of a known thrombus for consideration for placement of a vena cava filter device via the femoral approach. The medical necessity must be documented in the medical record.
3. Abdominal aortic aneurysms > four cm in diameter may be followed with abdominal ultrasound every six months. Documentation of medical necessity needs to be provided for studies performed more frequently.
4. The outcome must impact the clinical management of the patient. For example, if a patient is going to proceed on to other diagnostic and/or therapeutic procedures regardless of the outcome of the noninvasive studies, the non-invasive vascular studies are usually not medically necessary. That is, if it is obvious from the findings of the history and physical examination that the patient is going to proceed to angiography, then noninvasive vascular studies may not be medically necessary.

II. Penile Vascular Studies
Duplex scans of the arterial inflow and venous outflow of penile vessels have no therapeutic implications. Therefore, they are considered not medically reasonable or necessary, except in a patient with treatment failure who has sustained a documented groin injury where a vascular etiology for impotence is suspected.

Credentialing and Accreditation Standards
The 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. A vascular diagnostic study may be personally performed by a physician, a certified technologist, or in a certified vascular testing lab.

Services will be considered medically reasonable and necessary only if performed by appropriately trained providers.

1. All non-invasive vascular diagnostic studies must be performed meeting at least one of the following:

a. performed by a licensed qualified physician, or
b. performed by a technician who is certified in vascular technology, or
c. performed in facilities with laboratories accredited in vascular technology.

2. A licensed qualified physician for these services is defined as:

a. Having trained and acquired expertise within the framework of an accredited residency or fellowship program in the applicable specialty/subspecialty in ultrasound (US) or must reflect equivalent education, training, and expertise endorsed by an academic institution in ultrasound or by applicable specialty/subspecialty society in ultrasound, or
b. Has the Registered Vascular Technologist (RVT), Registered Physician Vascular Interpretation (RPVI), or ASN: Neuroimaging Subspecialty Certification; and
c. Is able to provide evidence of proficiency in the performance and interpretation of each type of diagnostic procedure performed.

3. Nonphysician personnel performing tests must demonstrate basic qualifications to perform tests and have training and proficiency as evidenced by licensure or certification by an appropriate State health or education department. In the absence of a State licensing board, non-physician personnel must be certified by an appropriate national credentialing body.

Appropriate personnel certification includes the American Registry of Diagnostic Medical Sonographers (ARDMS), Registered Vascular Technologist (RVT) credential; or Cardiovascular Credentialing International’s Registered Vascular Specialist (RVS).

4. Laboratories must be certified by one of the following:

• • Intersocietal Accreditation Commission (IAC),
  • American College of Radiology (ACR),
  • Joint Commission (Vascular lab certification would need to be noted under the main certification either under inpatient or ambulatory care depending on where the test is being performed), or
  • DNV-GL (specific for hospitals only)

According to which certifying body listed above is selected, that accrediting body’s standards must be followed.

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ACR. (Revised 2014). ACR Practice parameter for communication of diagnostic imaging findings. American College of Radiology Practice Parameter. Resolution 11. pp. 1-9.

ACR. (2011, Amended 2014). ACR-AIUM-SRU Practice parameter for performing and interpreting diagnostic ultrasound examinations. American College of Radiology. Resolution 39. pp.1-6.

ACR. (2010, Sep 9). Ultrasound accreditation program requirements. American College of Radiology. pp.1-10.

Intersocietal Accreditation Commission. (2013, Jun 15). IAC Standards and Guidelines for Vascular Testing Accreditation. pp. 1-67.

Abuhamad AZ, Benacerraf BR, Woletz P, Burke BL. The accreditation of ultrasound practices. Journal of Ultrasound in Medicine. 2004;23(8):1023-1029. doi:10.7863/jum.2004.23.8.1023

Gerhard-Herman M, Gardin JM, Jaff M, Mohler E, Roman M, Naqvi TZ. Guidelines for Noninvasive Vascular Laboratory Testing: A report from the American Society of Echocardiography and the Society of Vascular Medicine and Biology. Journal of the American Society of Echocardiography. 2006;19(8):955-972. doi:10.1016/j.echo.2006.04.019

Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 Practice guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic). Circulation. 2006;113(11). doi:10.1161/circulationaha.106.174526

Remer EM, Casalino DD, Arellano RS, et al. ACR appropriateness criteria® acute onset of scrotal pain — without trauma, without antecedent mass. Ultrasound Quarterly. 2012;28(1):47-51. doi:10.1097/ruq.0b013e3182493c97