Key conclusions are:
- CMS performed limited quality assurance checks and relied on labs' self-certification of their reported data. CMS's quality assurance activities that identified outliers or excluded data affected new rates for a few low-volume tests. Labs experienced some one-time challenges in complying with a new policy, but CMS's limited quality-assurance efforts present an ongoing risk.
- WHAT WE CONCLUDE
- Complete and accurate data are essential to setting payment rates for lab tests, and CMS should address challenges from 2017 to ensure data quality in the future. Effective outreach can help ensure that all labs required to report data comply during future data reporting periods. CMS can help ensure data quality by assessing quality assurance efforts and compliance activities.
- OIG will continue to issue an annual analysis of the top 25 lab tests, based on Medicare Part B payments, and other analyses that OIG determines appropriate regarding the implementation and effect of the new payment system.
ACLA and others have strongly complained the CMS process improperly excluded hospital lab payments. See ACLA's home page for the topic, here. CMS discussed and/or welcomed public input on its process in July 2018 PFS rulemaking; entry point here. See an August 2018 Genomeweb article about industry complaints about PAMA to the Hill, here.
OIG issues elaborate reports each fall on top CMS lab tests; they mention above they will continue to do so. Entry point here.
For an article on ADLT price gaming, here.
Separately: Affecting PFS services (including PFS lab tests), in PFS rulemaking in July 2018, CMS also released a truly massive database of new RUC/Supply/Equipment values for RVU-based services. This will affect RVU-based pathology tests. Entry point here.