LCD L34027

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 Ultrasound, Soft Tissues of Head and Neck. 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 Ultrasound, Soft Tissues of Head and Neck 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.

Internet Only Manual (IOM) Citations:

• CMS IOM Publication100-02, Medicare Benefit Policy Manual,

• Chapter 14, Section 10 Coverage of Medical Devices

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

• Chapter 13, 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 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.

Federal Register References:

• 42 CFR §410.32 - Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

Indications and Limitations of Coverage

Covered Indications

Ultrasound of the head and neck will be considered medically reasonable and necessary when used for the following indications:

• Evaluation of abnormalities in the tissues and/or organs of the head and neck (i.e., palpable masses)

• Evaluation of abnormalities detected on other imaging examinations (i.e., areas of abnormal uptake seen on radioisotope thyroid examinations)

• Personal or family history of thyroid malignancies

• Evaluation of suspected regional nodal metastases in patients with a proven thyroid carcinoma

• Follow-up of lesion/nodule (i.e., after medical suppression therapy)

• Localization of thyroid/parathyroid glands or cervical lymph nodes for biopsy, ablation, or other interventional procedures

For guidance regarding ordering tests, provider qualifications and supervision of diagnostic testing, please refer to 42 CFR §410.32 - Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

Limitations

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: Ultrasound, Soft Tissues of Head and Neck (A57029) 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: Ultrasound, Soft Tissues of Head and Neck (A57029) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

Bibliography

Marqusee E, Benson C, Frates MC, et al. How useful is ultrasonography in the management of thyroid nodules. Ann Intern Med. 2000;133(9):696-700.