LCD L33977

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 Transcranial Doppler Studies. 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 Transcranial Doppler Studies 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

Internet Only Manual (IOM) Citations:

• CMS IOM Publication 100-08, Medicare Program Integrity Manual,

• Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

• CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual,

• Chapter 1, Part 1, Section 20.14 Plethysmography, Section 20.17 Noninvasive Tests of Carotid Function

• Chapter 1, Part 4, Section 220.5 Ultrasound Diagnostic Procedures

Social Security Act (Title XVIII) Standard References:

• 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.

• 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.

Indications and Limitations of Coverage

History/Background and/or General Information

Transcranial doppler uses low-frequency doppler transducers applied across the thin portions of the temporal bone (the temporal acoustic windows) to obtain flow velocity information from the basal intracerebral arteries. The transtemporal acoustic window provides access to hemodynamic data from the middle, anterior, and posterior cerebral arteries. A suboccipital approach, with insonation through the foramen magnum, provides access to the intracranial vertebral and basilar arteries, while a transorbital approach can be used to insonate the ophthalmic artery and the carotid siphon via the optic foramen. This data allows evaluation of the direction, depth, speed, and characteristics of flow in these vessels.

Covered Indications

Transcranial doppler evaluation of the intracranial cerebrovascular system will be considered medically necessary in any of the following circumstances:

• The patient has suspected severe intracranial arterial stenosis based on finite clinical evidence of focal ischemia, and knowledge of this stenosis is necessary in order to properly care for the patient.

• The patient has areas of known severe stenosis or occlusion of arteries supplying the brain and assessment of the pattern and extent of collateral circulation is necessary in order to properly care for the patient.

• The patient has suffered a subarachnoid hemorrhage and transcranial doppler studies are necessary to assess vasoconstriction of cerebral vessels.

• The patient has suspected or confirmed arteriovenous malformation, and an assessment of the arterial supply and flow pattern is necessary.

• The patient has suspected brain death.

Limitations

Headaches or dizziness are not indications for transcranial doppler studies of the intracranial vessels unless associated with other localizing signs and symptoms such as nystagmus, limb ataxia, etc.

Transcranial doppler studies performed to monitor cerebral vascular resistance and the effects of vasodilators and other drugs in the treatment of stroke and other brain damage is considered investigational, and therefore not covered.

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 part of the physical examination of the vascular system and is not separately reported. The appropriate assignment of a specific ultrasound CPT code is not solely determined by the weight, size, or portability of the equipment, but rather by the extent, quality, and documentation of the procedure. If an examination is performed with hand-carried equipment, the quality of the exam, printout, and report must be in keeping with accepted national standards.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Summary of Evidence

N/A

Analysis of Evidence

N/A

Associated Information

Documentation Requirements

Please refer to the Local Coverage Article: Billing and Coding: Transcranial Doppler Studies (A57633) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.

Utilization Guidelines

Please refer to the Local Coverage Article: Billing and Coding: Transcranial Doppler Studies (A57633) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

Bibliography

Sloan, M.A., Alexandrov, A.V., Tegeler, C.H., Spencer, M.P., Caplan, L.R., Feldman, E., et al. (2004). Assessment: transcranial Doppler ultrasonography: report of the Therapeutics and Technology Assessment Subcommittee of The American Academy of Neurology. Retrieved September 13, 2005.

Society of Vascular Ultrasound-Professional performance guidelines. (2003). Transcranial Doppler (Non-Imaging). Retrieved September 13, 2005.