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HHS/CMS RIN: 0938-AS33 Publication ID: Fall 2014 
Title: ●Medicare Clinical Diagnostic Laboratory Test Payment System (CMS-1621-P) 
Abstract:

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.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 42 CFR 414   
Legal Authority: PL 113-93, sec 216   
Legal Deadline:
Action Source Description Date
Final  Statutory  Not later than June 30, 2015, parameters for data collection under this provision must be established through notice and comment rulemaking.  06/30/2015 
Timetable:
Action Date FR Cite
NPRM  12/00/2014 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Anne Hauswald
Director, Division of Ambulatory Services
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Medicare, Mail Sop C4-01-26, 7500 Security Blvd,
Baltimore, MD 21244
Phone:410 786-4546
Email: anne-e-tayloe.hauswald@cms.hhs.gov

Valerie Miller
Deputy Director, Division of Ambulatory Services
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Medicare, Mail Stop C4-01-26, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-4535
Email: valerie.miller@cms.hhs.gov