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Clinical Laboratory Reporting: Is Your Organization Ready for the New 2016 Reporting?

OnDemand Webinar (89 minutes)

Understand how your organization must comply with the new clinical laboratory reporting to avoid large daily fees.

How will the new payment rate reporting requirements impact your business? Effective January 1, 2017, Medicare will pay for most clinical laboratory tests using the weighted median of payments labs receive from other payers. Beginning January 1, 2016, each applicable laboratory must report the payment amount and volume of each test paid by each private payer, Medicare Advantage plan, and Medicaid managed care plan. Failure to comply with the reporting requirements may result in a civil money penalty of up to $10,000 per day. This topic will help personnel in clinical laboratories understand the rules for determining whether their lab is an applicable laboratory and thus required to report data on payments for their tests. It will help clinical laboratory personnel understand what data elements need to be collected and reported, and on what timeframes. Medicare's process for assigning payment rates to new tests - clinical diagnostic laboratory tests (CDLTs) and a subset of CDLTs called advanced diagnostic laboratory tests (ADLTs) - is also changing. This information will help you understand how CDLTs and ADLTs differ with respect to assignment of billing codes and payment rates and the key questions to consider in launching a new test on or after January 1, 2017.


Jennifer B. Madsen, MPH, Arnold & Porter LLP


Background on Section 216 of PAMA

• Legislative History

• Major Provisions of CMS' Proposed Rule

• Timelines for Reporting and New Payment Rates

• Definition of an Applicable Laboratory

Data Reporting Requirements

• Compliance Issues

• Operational Considerations for Labs to Report Data

• Questions CMS Hasn't Answered About Reporting

Advanced Diagnostic Laboratory Tests (ADLTs)

• FDA Pathway for ADLTs and Non-FDA Pathway for ADLTs

• Payment for New Tests

• Coding and Coverage

• Recommendations of the Advisory Panel for Clinical Diagnostic Laboratory Tests