0938-AS33 201410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0938 Centers for Medicare & Medicaid Services CMS 0900 Department of Health and Human Services HHS Medicare Clinical Diagnostic Laboratory Test Payment System (CMS-1621-P)

Under section 216 of the Protecting Access to Medicare Act of 2014, this proposed rule would require Medicare payment for clinical laboratory tests to be based on private payor rates beginning January 1, 2017. Beginning January 1, 2016, and every 3 years thereafter (or, annually, for certain laboratory tests), applicable laboratories must report to CMS the amount they are paid by each private payor for a test, and the volume of such tests performed for each such payer for the period. The payment rate reported by a laboratory must reflect all discounts, rebates, coupons, and other price concessions.

]]> Economically Significant First Time Published in The Unified Agenda Proposed Rule Stage Yes No 42 CFR 414 PL 113-93, sec 216 Statutory Final 06/30/2015 Not later than June 30, 2015, parameters for data collection under this provision must be established through notice and comment rulemaking. No NPRM 12/00/2014 Yes Businesses None No No Yes No Anne Hauswald Director, Division of Ambulatory Services 0938 Centers for Medicare & Medicaid Services CMS 410 786-4546 anne-e-tayloe.hauswald@cms.hhs.gov Center for Medicare, Mail Sop C4-01-26, 7500 Security Blvd, Baltimore MD 21244 Valerie Miller Deputy Director, Division of Ambulatory Services 0938 Centers for Medicare & Medicaid Services CMS 410 786-4535 valerie.miller@cms.hhs.gov Center for Medicare, Mail Stop C4-01-26, 7500 Security Boulevard, Baltimore MD 21244