The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released this week its FY2016 Work Plan (Work Plan). The OIG Work Plan summarizes new and ongoing OIG reviews of various HHS programs and activities, which are selected based on a number of factors such as mandatory OIG review requirements; requests from Congress, HHS management, or the Office of Management and Budget (OMB); and previously identified issues. Some key, new OIG reviews in the FY2016 Work Plan include the following:

Medicare Payments

  • Medicare payment during MS-DRG payment window. Billing practices are always a high priority for OIG reviews. This review will focus on Medicare payments to acute care hospitals to determine whether certain outpatient claims billed to Medicare Part B for services provided during inpatient stays were allowable and in accordance with the inpatient prospective payment system. The OIG noted that this is an area has been identified as an area of risk in prior OIG audits, investigations and inspections.
  • Skilled nursing facility prospective payment system requirements. The OIG intends to review compliance with various aspects of the skilled nursing facility (SNF) prospective payment system, including documentation requirements, billing at the highest levels of therapy, and care that was reasonable and necessary. SNFs have been an area of recent government enforcement and identified as an area of risk in prior OIG audits, investigations, and inspections.
  • Physicians–referring/ordering Medicare services and supplies. This review will determine whether physicians and non-physician practitioners who order services, supplies and/or durable medical equipment (DME) were appropriately enrolled in Medicare and legally eligible to refer or order the services, supplies or DME.

Drug Pricing

  • Increase in prices for brand-name drugs under Part D. The OIG will evaluate the extent to which pharmacy reimbursement for brand-name drugs under Medicare Part D changed between 2010 and 2014 compared to the rate of inflation for the same period.
  • Specialty drug pricing and reimbursement in Medicaid. The OIG will review how State Medicaid agencies define and determine payment for specialty drugs, which are often expensive and used to treat rare conditions, such as Hepatitis C, HIV, and certain cancers.

HIPAA Compliance

  • Controls over networked medical devices at hospitals. The OIG will examine whether the Food and Drug Administration’s (FDA) oversight of hospitals’ networked medical devices, such as dialysis machines, radiology systems, and medication dispensing systems, is sufficient to effectively protect associated electronic protected health information (ePHI) and ensure beneficiary safety.
  • Office for Civil Rights’ oversight of the security of electronic protected health information. The OIG will review the adequacy of the Office for Civil Rights (OCR) oversight over the security of ePHI. The OIG noted findings from prior OCR and OIG audits that have identified numerous issues.

More information on each of the above items and summaries of the OIG’s other focus areas are included in the full FY2016 Work Plan. The OIG Work Plan can serve as a useful resource for health care and life sciences companies planning and prioritizing compliance activities for the upcoming year, including training, auditing and monitoring.  Additionally, the OIG reports issued after an OIG review are a valuable source of information and insight regarding the OIG’s current analysis of industry issues.