Clinical Laboratory Services Based on the Negotiated Rulemaking

120 - Clinical Laboratory Services Based on the Negotiated Rulemaking (Rev. 1, 10-01-03) PM AB-02-129 Section 4554(b)(1) of the Balanced Budget Act (BBA), Public Law 105-33 mandated the use of a negotiated rulemaking committee to develop national coverage and administrative policies for clinical laboratory services payable under Part B of Medicare. The BBA required that these national policies be designed to promote program integrity and national uniformity; and to simplify administrative requirements with respect to clinical diagnostic laboratory services payable under Part B. These changes apply to every diagnostic clinical laboratory service that is payable under Medicare Part B. Neither the place where the service was performed, nor the type of A/B MAC (A) or (B) that will process the request for payment, has any effect on the applicability of these policies. A clinical laboratory service done in a hospital laboratory, independent laboratory, physician/practitioner office laboratory or other type of CLIA approved laboratory service is subject to these administrative policies. The final rule did not affect the requirement that all physician claims must have a diagnosis. If a physician submits a claim for a service performed in a physician office laboratory, that claim is considered a physician claim and must meet the requirements for physician claims.