Clinical Labs Center
Clinical Laboratory Data Reporting: Enforcement Discretion
On March 30, CMS announced that it will exercise enforcement discretion until May 30, 2017, with respect to the data reporting period for reporting applicable information under the Clinical Laboratory fee Schedule (CLFS) and the application of the Secretary’s potential assessment of civil monetary penalties for failure to report applicable information.
Effective January 1, 2018, Clinical Laboratory Fee Schedule rates will be based on weighted median private payor rates as required by the Protecting Access to Medicare Act (PAMA) of 2014. For more details, including how to prepare, collect and report data, visit PAMA Regulations.
- The CLIA Program and Medicare Laboratory Services [PDF, 1MB] is designed to provide education on CLIA test methods categorized, enrollment In the CLIA program, types of certificates, certificate compliance and performance measures, and certificate of accreditation.
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Billing / Payment
- Clinical Laboratory Fee Schedule
- Electronic Billing & EDI Transactions - Medicare information on electronic transactions under HIPAA
- Medicare Coverage - General Information
- National Coverage Determinations (NCD) Manual - Pub. 100-03
- Lab NCDs - ICD-9
- Laboratory National Coverage Determinations (NCDs) Index - Opens in a new window
- CLFS Regulations and Notices
- Code of Federal Regulation Citations
- Negotiated Rulemaking: Coverage and Administrative Policies for Clinical Diagnostic Laboratory Services
- Pages 58788-58836 [PDF, 3MB]
- Pages 58837-58886 [PDF, 1MB]
- Pages 58887-58890 [PDF, 424KB]
- Medicare Claims Processing Manual - Chapter 16 - Laboratory Services [PDF, 560KB]
- Chapter 15 – Covered Medical and Other Health Services [PDF, 1MB]
- Quarterly Provider Updates
- Clinical Laboratory Improvement Amendments (CLIA)
- Administrative Simplification Overview
- Social Security Act: 1833(h)(1)(A) - Opens in a new window
- Social Security Act: 1833(h)(5)(A) - Opens in a new window
- Physician Self Referral
- National Correct Coding Initiative Edits
- Column 1/Column 2 Pathology and Laboratory Services - ccigrp10.zip - Opens in a new window
- Mutually Exclusive Pathology and Laboratory Services - megrp9.zip - Opens in a new window
- HCPCS - General Information
- Alpha-Numeric HCPCS
- ICD-9-CM and ICD-10
- Claim Adjustment Reason and Remittance Advice Remark Codes - Opens in a new window The latest HIPAA codes are available at the Washington Publishing Company (WPC) Website.
Medicare Secondary Payer
- Medicare Provider-Supplier Enrollment
- Enrollment Applications
- Conditions for Coverage (CfCs) & Conditions of Participations (CoPs)
- Information for Medicare Fee-for-Service Providers for the National Provider Identifier Standard (NPI)
How to Stay Informed
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- End-Stage Renal Disease and Clinical Laboratories Open Door Forum
- Press Releases - Opens in a new window CMS Media Release Search