ACLA Files Notice of Appeal Regarding Denial of its Motion for Summary Judgement
The American Clinical Laboratory Association (ACLA) today, October 19, 2018, filed a "notice of appeal" in its lawsuit against the U.S. Department of Health and Human Services (HHS) challenging HHS's implementation of Section 216 of the Protecting Access to Medicare Act (PAMA).
ACLA is appealing a September 21, 2018, ruling by the U.S. District Court for Washington, D.C., denying ACLA's motion for Summary Judgement.
In denying the ACLA's motion, the D.C. District Court refused to consider the merits of ACLA's case, instead ruling that the court does not have "subject matter jurisdiction" because Section 216 of the PAMA statute prohibits administrative or judicial review. The Court ruled, in effect, that PAMA's prohibition against judicial review covers the entire statute and that CMS's determination of the weighted medians cannot be challenged regardless of the reasonableness, or fairness, of CMS's methodology.
In announcing its notice of appeal, ACLA stated that "While the District Court ruled on narrow procedural grounds, its opinion acknowledges that ACLA's arguments on the merits raise important questions about HHS's actions. We believe it is critically important for ACLA to be able to address these issues in court. While ACLA continues to pursue legal action, we also call on Congress to reform and modernize the Clinical Laboratory Fee Schedule to ensure that beneficiaries can continue to access the lab services and diagnostics they need."