LCD L34021

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 Sedimentation Rate, Erythrocyte. 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 Sedimentation Rate, Erythrocyte 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 Publication 100-02, Medicare Benefit Policy Manual,

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

• 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:

• Code of Federal Regulations (CFR), Title 42, Volume 2, Chapter IV, Part 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

Indications and Limitations of Coverage

History/Background and/or General Information

The erythrocyte sedimentation rate (ESR) is a sensitive but nonspecific test that is frequently the earliest indicator of disease when other chemical or physical signs are normal. It is most often used as a gauge for determining the progress and detection of an inflammatory disorder caused by infection, autoimmune mechanisms, or connective tissue disease.

Covered Indications

An ESR will be considered medically reasonable and necessary for one of the following conditions:

• Aiding in the diagnosis of temporal arteritis (giant cell arteritis) and polymyalgia rheumatic

• Monitoring disease activity in temporal arteritis and polymyalgia rheumatica for the principal indication of adjusting the dosage of corticosteroids

• Monitoring patients with treated Hodgkin’s disease

• Monitoring patients with autoimmune diseases, inflammatory disorders caused by infection, or connective tissue diseases

An ESR should be used selectively in patients with symptoms that are not explained by results of a careful history and physical examination. Rapid screen for elevated protein or globulin level in serum ESR may be used with or replaced by C-Reactive protein in evaluation of unexplained inflammatory states .

Limitations

This service is not medically necessary for screening purposes.

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: Sedimentation Rate, Erythrocyte (A57657) 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: Sedimentation Rate, Erythrocyte (A57657) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

Bibliography

N/A