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LCD ID Number: L39365 Status: A-Approved
LCD Title: Genetic Testing for Oncology
Geographic Jurisdiction: Delaware Other Jurisdictions
Original Determination Effective Date:
07/17/2023
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 genetic testing for oncology. 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 genetic testing for oncology 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:
IOM Citations:
- CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
- Chapter 15, Section 80.1 Clinical Laboratory Services and Section 280 Preventive and Screening 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 3, Section 190.3 Cytogenetic Studies
- Chapter 1, Part 4, Section 210.3 Colorectal Cancer Screening Tests
- CMS IOM Publication 100-08, Medicare Program Integrity Manual,
- Chapter 13, Section 13.5.4 Reasonable and Necessary Provisions in an LCD
Medicare National Correct Coding Initiative (NCCI) Policy Manual:
- Chapter 10, Section A Introduction
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.
Code of Federal Regulations (CFR) References:
- CFR, Title 42, Volume 2, Chapter IV, Part 410.32(a), Part 410.32(d), and Part 410.32(e) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions
- CFR, Title 42, Volume 2, Chapter IV, Part 411.15(k)(1) Particular services excluded from coverage
- CFR, Title 42, Volume 2, Chapter IV, Part 493 Laboratory Requirements
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