On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015.  The Work Plan is a compilation of the OIG’s plans for new and ongoing reviews and activities (including audits, evaluations, and certain legal and investigative initiatives) with respect to HHS programs and operations, for 2015 (and beyond).  The OIG summarized its FY2015 plans as follows:

“In FY 2015 and beyond, we will continue to focus on emerging payment, eligibility, management, and IT systems security vulnerabilities in health care reform programs, such as the health insurance marketplaces. OIG plans to add to its portfolio of work on care quality and access in Medicare and Medicaid, as well as on public health and human services programs. OIG’s examination of the appropriateness of Medicare and Medicaid payments will continue, with possible additional work on the efficiency and effectiveness of payment policies and practices in inpatient and outpatient settings, for prescription drugs, and in managed care. Other areas under consideration for new work include, for example, the integrity of the food, drug, and medical device supply chains; the security of electronic data; the use and exchange of health information technology; and emergency preparedness and response efforts.”

Some of the new and ongoing Work Plan items that may be particularly relevant to companies in the pharmaceutical, biologic and/or biotechnology industries include the following (items that did not appear in the 2014 Work Plan are bolded):


Under “Hospitals”:

  • Bone marrow or stem cell transplants
  • Oversight of pharmaceutical compounding

Under “Medical Equipment and Supplies”:

  • Competitive bidding for diabetes testing supplies—Market share review
  • Nebulizer machines and related drugs—Supplier compliance with payment requirements
  • Diabetes testing supplies—Supplier compliance with payment requirements for blood glucose test strips and lancets
  • Diabetes testing supplies—Effectiveness of system edits to prevent inappropriate payments for blood glucose test strips and lancets to multiple suppliers

Under “Other Providers and Suppliers”:

  • End-stage renal disease facilities—Payment system for renal dialysis services and drugs
  • Selected independent clinical laboratory billing requirements (new)


Under “Prescription Drugs”:

  • Comparison of average sales prices to average manufacturer prices
  • Part B payments for drugs purchased under the 340B Program
  • Payments for immunosuppressive drug claims with KX modifiers
  • Payments for outpatient drugs and administration of the drugs
  • Covered uses for Medicare Part B drugs
  • Ethics—Conflicts of interest involving prescription drug compendia

Under “Information Technology Security, Protected Health Information, and Data Accuracy”:

  • Controls over networked medical devices at hospitals

Under “Part D – Prescription Drug Program”:

  • Documentation of administrative costs in sponsors’ bid proposals
  • Reconciliation of payments—Sponsor reporting of direct and indirect remuneration
  • Reconciliation of payments—Reopening final payment determinations
  • Ensuring dual eligibles’ access to drugs under Part D
  • Recommendation followup: Oversight of conflicts of interest in Medicare prescription drug decisions (new)
  • Documentation of pharmacies’ prescription drug event data
  • Medicare payments for HIV drugs for deceased beneficiaries
  • Quality of sponsor data used in calculating coverage-gap discounts


Under “Medicaid Prescription Drug Reviews”:

  • States’ use of Medicaid drug utilization review to reduce the inappropriate dispensing of opioids
  • Manufacturer compliance with AMP reporting requirements
  • States collection of rebates on physician-administered drugs
  • State collection of rebates for drugs dispensed to Medicaid MCO enrollees (new)
  • States’ collection and reporting of rebates
  • Comparison of Medicare Part D and Medicaid pharmacy reimbursement and rebates
  • Medicaid payments for multiuse vials of Herceptin


Under “Food and Drug Administration”:

  • FDA—Inspection of generic drug manufacturers
  • FDA—Oversight of postmarketing studies of approved drugs
  • FDA—Review of information exchange in the drug supply chain
  • FDA—Drug sponsors’ compliance with clinical trial reporting requirements

Under “Health Resources and Services Administration”:

  • HRSA-Community health centers’ compliance with grant requirements of the Affordable Care Act (new)
  • HRSA—Duplicate discounts for 340B purchased drugs (new)
  • HRSA—Oversight of vulnerable health center grantees (new)

Trick or treat? Perhaps a bit of both.  As a summary of some of the OIG’s current enforcement initiatives, the Work Plan can serve as a useful resource for companies in planning and prioritizing internal audits, monitoring and training activities.  Accordingly, companies should review the Work Plan as one reference for determining their own compliance focus areas for the upcoming year.  More information on each of the above items, as well as summaries of the OIG’s other enforcement initiatives, are included in the full 2015 Work Plan.  In addition, the reports that are issued following various OIG reviews can be excellent sources of information and insight into the OIG’s current “thinking” on issues.  Of course, because the OIG has significant enforcement authority (including the ability to assess various civil monetary penalties), any company receiving a “knock” from the OIG, whether or not related to a Work Plan item, should consult their legal counsel in properly responding.

Posted by Kathleen Peterson

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