Wednesday, 26 September 2018 16:43

ACLA PAMA Lawsuit Dismissed for Lack of Subject Matter Jurisdiction

The American Clinical Laboratory Association (ACLA), a trade association representing clinical laboratories, challenged a regulation issued by the Secretary of the U.S. Department of Health and Human Services (DHHS), specifically, Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”). Their complaint was that requiring certain laboratories, “applicable laboratories,” to report pricing information to the agency for use in establishing Medicare rates violates PAMA. DHHS asserts that in the statute, Congress expressly precluded judicial review on this issue, and the US District Court for the District of Columbia has no jurisdiction to hear the case. DC District Court Judge Amy Berman Jackson acknowledged that the ACLA’s arguments on the merits raise important questions but agreed with DHHS that it cannot resolve this dispute, and dismissed the matter for lack of subject matter jurisdiction. You can read the opinion here. The ACLA is currently reviewing its legal options. ASM, with other members of the Clinical Laboratory Coalition, have been meeting to address the coming laboratory test reimbursement cuts and possible legislative action and will continue to report to the membership on this issue.