LCD ID Number: L35396 Status: A-Approved
LCD Title: Biomarkers for Oncology
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 biomarkers for oncology 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 biomarkers for oncology 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 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, Section 80.1 Clinical Laboratory Services
- CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual,
- Chapter 1, Part 2, Section 90.2 Next-Generation Sequencing for Patients with Advanced Cancer
- Chapter 1, Part 4, Section 210.3 Colorectal Cancer Screening Tests
- CMS IOM Publication 100-08, Medicare Program Integrity Manual,
- Chapter 3, Section 126.96.36.199 Diagnosis Code Requirements, Section 188.8.131.52 Limitations of Liability Determinations
- Chapter 13, Section 13.5.4 Reasonable and Necessary Provisions 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.
Code of Federal Regulations (CFR) References:
- CFR, Title 42, Volume 2, Chapter IV, Part 410.32(d)(3) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.
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05/16/2022 11:57:31 184.108.40.206