LCD ID Number: L38229 Status: A-Approved
LCD Title: Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid Amplification Techniques (NAATs)
Geographic Jurisdiction: Delaware Other Jurisdictions
Original Determination Effective Date:
12/30/2019
Original Determination Ending Date:
Revision Effective Date:
10/26/2023
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 GIP panels utilizing multiplex NAATs. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy and 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 GIP panels utilizing multiplex NAATs and must properly submit only valid claims. The medical necessity provisions in this LCD must be applied 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 80.1 Clinical Laboratory Services and Section 80.6 Requirements for Ordering and Following Orders for Diagnostic Tests
- CMS IOM Publication 100-04, Medicare Claims Processing Manual,
- Chapter 16, Laboratory Services
- 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 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, Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.
- CFR, Title 42, Volume 2, Chapter IV, Part 411.15(a), Particular services excluded from coverage.
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