LCD ID Number: L39063 Status: A-Approved
LCD Title: Pharmacogenomics Testing
Geographic Jurisdiction: Arkansas 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 pharmacogenomics testing. 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 pharmacogenomics testing 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, Section 80.1.1 Certification Changes, Section 80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories, Section 80.1.3 Independent Laboratory Service to a Patient in the Patient’s Home or an Institution, Section 80.6 Requirements for Ordering and Following Orders for Diagnostic Tests, Section 80.6.1 Definitions, and Section 280 Preventive and Screening Services
- CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual,
- Chapter 1, Part 2, Section 90.1 Pharmacogenomic Testing to Predict Warfarin Responsiveness and Section 90.2 Next Generation Sequencing for Patients with Advanced Cancer
- 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 1861(ww)(1). This section defines the initial preventative physical examination which does not include laboratory tests.
- Title XVIII of the Social Security Act, Section 1861(xx)(1). This section defines cardiovascular screening blood test.
- Title XVIII of the Social Security Act, Section 1861(ddd)(1). This section defines additional preventative services. Section 1861(ddd)(2). This section describes the process for making national coverage determinations. Section 1861(ddd)(3). This section defines preventative services.
- Title XVIII of the Social Security Act, Section 1861(hhh) defines the annual wellness visit services.
- 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 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions
- CFR, Title 42, Volume 2, Chapter IV, Part 410.64 Additional preventive services
- CFR, Title 42, Volume 2, Chapter IV, Part 411.15(k) Particular services excluded from coverage
- CFR, Title 42, Volume 5, Chapter IV, Part 493 Laboratory Requirements
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