Title XVIII of Social Security Act, Section 1861 Act provides for payment of clinical laboratory services under Medicare Part B. Clinical laboratory services involve the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.
Title XVIII of Social Security Act, Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
Title XVIII of Social Security Act, Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.
42 CFR part 493, laboratory services must meet all applicable requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), as set forth. Section 1862(a)(1)(A) provides that Medicare payment may not be made for services that are not reasonable and necessary.
42 CFR 410.32(a), clinical laboratory services must be ordered and used promptly by the physician who is treating the beneficiary.
42 CFR 410.32(a) (3), or by a qualified nonphysician practitioner.
CMS Pub 100-02, Medicare Benefit Policy Manual, Chapter 15 - Covered Medical and Other Health Care Services, §80.1 – Clinical Laboratory Services and 80.6 – Requirements for Ordering and Following Orders for Diagnostic Tests.
CMS Pub. 100-04, Medicare Claims Processing Manual, Chapter 1- General Billing Requirements, Sections 60 – Provider Billing of Non-covered Charges on Institutional Claims – 60.1.1 - Basic Payment Liability Conditions.
CMS Pub 100-04, Medicare Claims Processing Manual, Chapter 25 – Completing and Processing the Form CMS-1450 Data Set, Section 75.5 – From Locators 43-81, FL-67 Principal Diagnosis Codes.
CMS Transmittal No, 857, effective date October 3, 2018 Change Request 10901 Local Coverage Determinations (LCDs) Implementation date January 8, 2019.
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