The Health and Human Services Office of Inspector General (OIG) released last week an updated mid-year Work Plan for FY2015, which removes items that have been completed, postponed, or canceled and includes new items that have been started since October 2014. The FY2015 OIG Work Plan that we previously discussed is available here.

Notably, 21 items were added to the OIG’s mid-year Work Plan. Some key additions include the following areas:

• Review of Financial Interests Reported under the Open Payments Program. The OIG intends to determine (i) the number and nature of financial interests that were reported to the Centers for Medicare & Medicaid Services (CMS) under the Open Payments Program; (ii) the extent to which CMS oversees manufacturer and group purchasing organization (GPO) compliance with data reporting requirements; and (iii) whether the reported data is accurately and completely displayed in the publicly available database. According to the OIG, it is “important that the information be complete and accurate to serve the needs of consumers making educated decisions about their health care choices.” This update is timely given the anticipated publication of 2014 data by CMS on June 30, 2015 and recent release of its annual report to Congress.
• Annual Analysis of Medicare Clinical Laboratory Payments. As we discussed here, there have been a number of recent government enforcement announcements related to clinical laboratory payments that violated the federal Anti-Kickback Statute. The OIG intends to analyze Medicare payments for clinical diagnostic laboratory tests, including the top 25 clinical diagnostic laboratory tests by Medicare expenditures in 2014.
• Billing Trends for Part D Drugs and Commonly Abused Opioids. The OIG intends to describe trends in Part D billing from 2006 to 2014, including changes in billing for commonly used opioid drugs and billing trends associated with pharmacies in 2014. In the mid-year Work Plan, the OIG notes that it is “seeing a significant increase in Part D fraud and has a wide portfolio of work involving pharmaceutical matters, including prescription drug diversion.” This is notable because of government enforcement actions, such as the investigation and suit filed by the City of Chicago, which alleged that five pharmaceutical manufacturers marketed opioids in violation of Illinois’ consumer fraud laws and caused doctors and pharmacies to submit false claims to the city for payment (currently, only the suit against one pharmaceutical company is active).

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