Proposed rule will create significant, retroactive reporting requirements for private payor payment rates to clinical laboratories.

Many clinical laboratories will need to expend significant resources to track, collect and report private payor payment rates for certain of their tests, retroactively from July 1, 2015, through December 31, 2015, in order to comply with the Centers for Medicare & Medicaid Services (CMS)’s proposed rule published on October 1, 2015, in the Federal Register (Proposed Rule). The Proposed Rule outlines CMS’s proposed approach to implementing Section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA). PAMA established a new payment system for clinical diagnostic laboratory tests (CDLTs) and certain molecular diagnostic tests that meet the definition of advanced diagnostic laboratory tests (ADLTs). Under the new Medicare payment system, Medicare payments for CDLTs and ADLTs will be tied to private payor payment rates, such as commercial health plans and Medicare and Medicaid managed care plans (with certain exceptions for new tests).