BIO Comments on CMS PAMA Proposed Rule

The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS) Proposed Rule entitled Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System.

In these comments, BIO will address concerns with specific provisions of the Proposed Rule such as the definition of “applicable laboratory”, the definition of Advanced Diagnostic Laboratory Tests (ADLTs), and the rate establishment process for new ADLTs.  BIO will also provide recommendations on the local coverage determination process and designation of Medicare Administrative Contractors for CDLTs.  We appreciate the opportunity to provide these comments.  

BIO supports the provisions under section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA) that reform the Medicare payment system for clinical diagnostic laboratory tests (CDLTs) to a market-based payment system that reflects the value these tests bring to patient care.  We share CMS’ objective to implement these PAMA requirements in a manner that is transparent, efficient, and fair.  We believe that any new market-based payment system must allow for the reflection of not only the cost of performing these diagnostics tests but also the cost of development and clinical validation.  Successful implementation will help enhance patient access to high-quality, innovative diagnostic tests that can help guide clinical decision making.