LCD ID Number: L37792 Status: A-Approved
LCD Title: 4Kscore Test Algorithm
Geographic Jurisdiction: Maryland Other Jurisdictions
Original Determination Effective Date:
03/21/2019
Original Determination Ending Date:
Revision Effective Date:
12/30/2019
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 the 4Kscore test algorithm. 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 4Kscore test algorithm 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 Covered Medical and Other Health Services, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests
- CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1,
- Part 3, Section 190.31 Prostate Specific Antigen
- Part 4, Section 210.1 Prostate Cancer Screening 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 Local Coverage Determinations, Section 13.5.4 Reasonable and Necessary Provisions in LCDs
Social Security Act (Title XVIII) Standard References:
- 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.
- 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.
Federal Register References:
- Code of Federal Regulations (CFR), Title 42, Chapter IV, Subchapter B, Part 410, Subpart B, Section 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.
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