News at a Glance – Dec 2015

DOJ Reports $1.9 Billion in Healthcare False Claims Act Recoveries for FY 2015. The Department of Justice (DOJ) recovered $1.9 billion in Healthcare False Claims Act cases in fiscal year (FY) 2015. That's more than half of the aggregate $3.5 billion the DOJ reported recovering under all False Claims Act cases for the fiscal year ending Sept. 30. This year's $1.9 billion brings the total health care recoveries under the False Claims Act since January 2009 to almost $16.5 billion. Noting the Yates memo's call to hold individuals responsible for corporate wrongdoing, the DOJ highlighted the individuals being pursued as a result of the cases against cardiovascular testing laboratories Health Diagnostics Laboratory (HDL) and Singulex. The government settled with HDL and Singulex for $48.5 million and has intervened in qui tam actions brought against individual owners and founders of the entities involved.

FDA Workshop Addresses Security of Medical Devices. The U.S. Food and Drug Administration (FDA) warns of the cybersecurity risks relating to wireless, internet- and network-connected devices and electronic exchange of health information and is holding a two-day workshop Jan. 20-21, 2016, titled "Moving Forward: Collaborative Approaches to Medical Device Cybersecurity." The FDA explains the risks of compromised medical devices "could have a profound impact on patient care and safety." Thus, the workshop will include discussions of awareness, "cyber hygiene," information sharing, identifying and managing medical device cyber vulnerabilities, and vulnerability disclosures. Written comments on the issues can be submitted through Feb. 22, 2016. For more information and to register, visit the FDA website. Laboratorians are directly affected by these cyber risks as diagnostic technology becomes more mobile and laboratories and their data become more connected. A September FDA workshop focused on "semantic interoperability of laboratory data between in vitro diagnostic devices and database systems, including laboratory information systems and electronic health records."

CMS Software Glitch Affects Reference Lab Claims. A glitch in updated software the Centers for Medicare & Medicaid Services (CMS) sent to its regional administrative contractors all but halted payments for reference lab claims submitted between Oct. 1 and the start of this month. Sector officials say the mishap was tied to CMS' decision last May to require any reference claims be submitted with not only the CLIA number of the referring laboratory, but also the NPI number for the clinician or laboratory contractor that performed the test. However, virtually all of those claims were being rejected as not recognizing the NPI, according to JoAnne Glisson, senior vice president with the American Clinical Laboratory Association. On Dec. 10, less than three weeks after being notified about the issue, CMS forwarded the following announcement to the MACs: "A claims processing issue affecting claims for reference lab services and services subject to the anti-markup payment limitation, which were billed on or after Oct. 1, 2015 has been resolved. Medicare Administrative Contractors (MACs) are reprocessing these claims. No further action is needed by providers/suppliers."