Policy gurus seeking the latest information on how governmental policies and regulations affect clinical labs should attend the AACC/American Society for Clinical Laboratory Science (ASCLS) Healthcare Forum: Government Affairs Update (34214), a session that’s become a staple at the AACC Annual Scientific Meeting & Clinical Lab Expo.

This year’s forum takes place from 2:30 p.m. to 5 p.m. on Aug. 2 and is worth 2.5 CE hours. Its purpose is to provide clinical laboratory professionals with the latest information on key government topics affecting laboratory operations, focusing generally on regulatory and payment issues. 

A highly anticipated talk by Charles Root PhD, founder and CEO of the reimbursement and compliance consulting firm CodeMap, spotlights the Protecting Access to Medicare Act (PAMA), a statute that rebases Medicare’s clinical laboratory fee schedule to reflect private sector rates. Starting in 2018, Medicare will be reimbursing labs based on rates paid by commercial payers. For many labs, this will mean a reduction in fees.

Not all labs have found it easy to comply with PAMA regulations. To assist, the Centers for Medicare and Medicaid Services (CMS) has been issuing guidance and earlier this year extended a deadline to collect and report 2016 private sector data, after too many labs struggled to meet it. In his talk, “PAMA and the New Payment Paradigm,” Root will discuss rate setting and current implementation timelines and other PAMA pricing issues, as well as new routes to payment for new tests and reimbursement and coverage for molecular assays. An estimated 12,400 physician office laboratories and 1,200 independent laboratories were required to report PAMA data by June 1, Root notes.

In other discussions, Karen Dyer, BA, director of the Division of Laboratory Services with CMS’ Center for Medicaid and State Operations, will give an update on CMS’ Clinical Laboratory Improvement Amendments (CLIA) program, including a new pilot project to promote the field of clinical laboratory science at community colleges and universities. Alberto Gutierrez, PhD, director of U.S. Food and Drug Administration’s (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety in the Center for Devices and Radiological Health, is giving a presentation on the FDA’s views on how the agency should regulate next-generation sequencing testing. Finally, Elissa Passiment, EdM, senior partner at EP Clinical Lab Consulting in Okatie, South Carolina, will offer up a big picture approach on the role of clinical laboratorians in the changing healthcare environment.

Whether you’re a policy junkie or working in a lab that’s bracing for PAMA’s rebasing of the clinical laboratory fee schedule, be sure to attend the health policy forum, one of many exciting events at the 69th AACC Annual Scientific Meeting & Clinical Lab Expo, July 30–Aug. 3 in San Diego.