CMS, OIG Reps Address PAMA, Fraud Enforcement at ACLA Annual Meeting

At the American Clinical Laboratory Association annual meeting in Washington, D.C. March 23, representatives of the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) provided insight on current challenges facing laboratories.

Carol Blackford, Director, Hospital and Ambulatory Policy Group of CMS reported on current implementation of the Protecting Access to Medicare Act (PAMA) and mentioned the agency has received requests for an extension of the March 31 reporting deadline under PAMA. She was unable to say at that time whether a delay in that deadline would happen. However, CMS announced as we went to press that it would exercise enforcement discretion until May 30.

Senior Counsel Karen Glassman of the U.S. Department of Human Services OIG highlighted recent enforcement efforts and noted common fraud theories applicable for laboratories include billing for tests not ordered or performed, improper CPT and diagnosis coding, lack of medical necessity and Stark and Anti-Kickback violations. Among the latest fraud trends she discussed were marketing arrangements, genetic testing scams and medical necessity issues.

Glassman also discussed the collaborative nature of enforcement, with federal agencies cross referring cases and findings of their reports and investigations. While reviewing recent settlements and enforcement cases in the laboratory sector and the compliance issues at the heart of those cases, she emphasized the OIG's focus on individual accountability. In response to a question about the future of individual responsibility under the Yates memo now that Sally Yates is no longer deputy attorney general, Glassman responded that she couldn't speak for the DOJ (the agency that released the Yates memo) but that the Yates memo "only reiterated what [the OIG's] focus has been for a long time." She also indicated that OIG focus on holding individuals responsible was likely to continue.

Finally, Glassman ended with some compliance tips for laboratories: Treat compliance as a team sport, involving all areas of the organization, use compliance metrics and include compliance in employee performance reviews to provide compliance incentives, stay up-to-date with OIG publications and guidance such as the Work plan that indicate the areas it is concerned about and evaluate the organization's risks.

Takeaway: Labs face significant compliance and reimbursement challenges and government agencies seek to provide resources to help.