Billing and Coding: Non-Invasive Vascular Studies

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

220.21 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

This article gives guidance for billing, coding, and other guidelines in relation to local coverage policy Non-Invasive Vascular Studies L34045.

It is the responsibility of the physician/provider to ensure the medical necessity of procedures and to maintain records in the event that records are requested for a post-payment audit.

42 CFR §410.32 indicates that diagnostic tests, to be covered, must be ordered by the practitioner who treats the patient. The treating physician is the practitioner responsible for the treatment of the patient. He/she orders the test to use the results in the management of the beneficiary’s specific medical problem(s). Consulting physicians may also order tests.

A referral for one non-invasive study is not a blanket referral for all studies. A referral must be on record for each non-invasive study performed.

Documentation must be provided supporting the need for more than one imaging study [Doppler flow (93990) or vessel mapping (G0365) and arteriogram (75790/75820)].

Providers of interpretations and the technical portion of the examination must be capable of demonstrating documented training and experience and maintain documentation for post-payment audit.


Frequency of follow-up studies will be carefully monitored for medical necessity and it is the responsibility of the physician/provider to maintain documentation of medical necessity in the patient’s medical record.

Guidelines for follow-up cerebrovascular arterial studies include:

• Stenosis of 20-49% (diameter reduction), an annual study;
• Stenosis of 50-79%, every six months;
• Stenosis of 80-99%, every 6 months if surgery not performed; and/or
• After carotid endarterectomy, repeat ipsilateral/unilateral examinations are allowable at six weeks, six months, and one year. During the first year, follow-up studies should be on the ipsilateral side unless signs and symptoms or previously identified disease in the contralateral carotid artery provide indications for a bilateral procedure.

If patients become symptomatic of carotid disease repeat duplex scans are allowed without regard to the above schedule.

Pre-surgical conduit mapping of the radial artery(ies) should only be accompanied by vein-mapping studies when the arterial studies demonstrate a non-acceptable conduit or an insufficient conduit is available for multiple bypass procedures.

In the immediate post-operative period, patients may be studied if re-established pulses are lost, become equivocal, or if the patient develops related signs and/or symptoms of ischemia with impending repeat intervention.

With regard to autogenous vein and synthetic lower extremity bypass surgeries, a study may be performed at three-month intervals during the first year, at six-month intervals during the second year, and annually thereafter. The frequency of medically necessary follow-up studies post-angioplasty is dictated by the vascular distribution treated.

General Guidelines for Claims submitted to Part A or Part B MAC:

Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare. For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim. A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act. The diagnosis code(s) must best describe the patient's condition for which the service was performed. For diagnostic tests, report the result of the test if known; otherwise the symptoms prompting the performance of the test should be reported.

Advance Beneficiary Notice of Non-coverage (ABN) Modifier Guidelines

An ABN may be used for services which are likely to be non-covered, whether for medical necessity or for other reasons. Refer to CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 30, for complete instructions.

Effective from April 1, 2010, non-covered services should be billed with modifier –GA, -GX, -GY, or –GZ, as appropriate.

The –GA modifier (“Waiver of Liability Statement Issued as Required by Payer Policy”) should be used when physicians, practitioners, or suppliers want to indicate that they anticipate that Medicare will deny a specific service as not reasonable and necessary and they do have an ABN signed by the beneficiary on file. Modifier GA applies only when services will be denied under reasonable and necessary provisions, sections 1862(a)(1), 1862(a)(9), 1879(e), or 1879(g) of the Social Security Act. Effective April 1, 2010, Part A MAC systems will automatically deny services billed with modifier GA. An ABN, Form CMS-R-131, should be signed by the beneficiary to indicate that ‎he/she accepts responsibility for payment.‎ The -GA modifier may also be used on assigned claims when a patient refuses to sign the ABN and the latter is properly witnessed. For claims submitted to the Part A MAC, occurrence code 32 and the date of the ABN is required.

Modifier GX (“Notice of Liability Issued, Voluntary Under Payer Policy”) should be used when the beneficiary has signed an ABN, and a denial is anticipated based on provisions other than medical necessity, such as statutory exclusions of coverage or technical issues. An ABN is not required for these denials, but if non-covered services are reported with modifier GX, will automatically be denied services.

The –GZ modifier should be used when physicians, practitioners, or suppliers want to indicate that they expect that Medicare will deny an item or service as not reasonable and necessary and they have not had an ABN signed by the beneficiary. ‎If the service is statutorily non-covered, or without a benefit category, submit the ‎appropriate CPT/HCPCS code with the -GY modifier. An ABN is not required for these denials, and the limitation of liability does not apply for beneficiaries. Services with modifier GY will automatically deny.

Documentation Requirements

The patient’s medical record should include but is not limited to:

• The assessment of the patient by the ordering provider as it relates to the complaint of the patient for that visit,
• Relevant medical history
• Results of pertinent tests/procedures
• Signed and dated office visit record/operative report (Please note that all services ordered or rendered to Medicare beneficiaries must be signed.)

Other Comments:

For claims submitted to the Part A MAC: This coverage determination also applies within states outside the primary geographic jurisdiction with facilities that have nominated CGS Administrators, LLC to process their claims.

Bill type codes only apply to providers who bill these services to the Part A MAC: Bill type codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC.

For dates of service on or after April 1, 2010, bill type 77X should be used to report FQHC services.

Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes.

For outpatient settings other than CORFs, references to "physicians" throughout this policy include non-physicians, such as nurse practitioners, clinical nurse specialists and physician assistants. Such non-physician practitioners, with certain exceptions, may certify, order and establish the plan of care as authorized by State law. (See Sections 1861[s][2] and 1862[a][14] of Title XVIII of the Social Security Act; 42 CFR, Sections 410.74, 410.75, 410.76 and 419.22; 58 FR 18543, April 7, 2000.)