This Local Coverage Determination (LCD) supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for colon capsule endoscopy (CCE). 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 CCE 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 Centers for Medicare and Medicaid Services (CMS) manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS website.
Title XVIII of the Social Security Act, §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, §1862(a)(7) excludes routine physical examinations
42 CFR §410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions
42 CFR §410.33 Independent diagnostic testing facility
42 CFR §414.510 Laboratory date of service for clinical laboratory and pathology specimens
CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, §210.3 Colorectal Cancer Screening Tests
CMS Internet-Only Manual, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, §13.5.4 Reasonable and Necessary Provision in an LCD
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