LCD ID Number: L35062 Status: A-Approved
LCD Title: Biomarkers Overview
Geographic Jurisdiction: District of Columbia Other Jurisdictions
Original Determination Effective Date:
Original Determination Ending Date:
Revision Effective Date:
Revision End Date:
CMS National Coverage Policy:
This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for biomarker overview services. 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 biomarker overview services 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 regarding services may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.
- CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Sections 80.1, 80.1.1, 80.1.2, 80.1.3, Laboratory services must meet applicable requirements of CLIA, and Section 280, Preventive and Screening Services
- CMS IOM Publication 100-08, Medicare Program Integrity Manual,
- Chapter 3, Sections 126.96.36.199 Diagnosis Code Requirements and 188.8.131.52 Limitation of Liability Determinations
- 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 may 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.
Code of Federal Regulations (CFR) References:
- CFR, Title 42 Section 410.32: Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions
- CFR, Title 42 Section 411.15: Particular services excluded from coverage
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