4 New Areas of Oversight Compliance Leaders Should Watch
compliance, medicare, oig work plan, FDA, OIG Work Plan Updates, NIH, OIG Work Plan 2025, OIG Updates 2025
The OIG added four items to its work plan in May 2025. Compliance professionals should be aware of the issues and assess their own organization to determine if the new Work Plan items affect them.
Minimum Spend Requirements in Nursing Homes
It should come as no surprise that the OIG is focused on care provided in nursing facilities. Some of the recent announcements or publications on their website have included:
- Audit of Medicaid Nursing Facility Use of Funds Related to Direct Patient Care (https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000748.asp)
- Selected Skilled Nursing Facilities Did Not Comply With Medicare Requirements for Reporting Related-Party Costs (https://oig.hhs.gov/reports/all/2024/some-selected-skilled-nursing-facilities-did-not-comply-with-medicare-requirements-for-reporting-related-party-costs/)
- Nursing Facility Industry Segment-Specific Compliance Program Guidance (https://oig.hhs.gov/compliance/nursing-facility-icpg/)
This, and other work they have and plan to perform, highlights the importance of understanding how Medicaid spending has an impact on the care provided to residents in nursing homes. Some states have established their own nursing home minimum spending requirements related to resident care.
This OIG Work Plan item states they will perform an audit that provides CMS and other stakeholders (e.g., Congress and states) with information on how these states ensure that nursing home revenues are related to resident care expenditures. They also plan to determine how the states have implemented nursing home minimum spending requirements related to resident care and identify challenges that the states and nursing homes have experienced in implementing and complying with those requirements.
Audit of NIH Grant Recipients
Legislation known as the Federal Funding Accountability and Transparency Act of 2006 (FFATA) requires prime grant award recipients of Federal funds to report information on Federal awards and subawards on a public, single, searchable website, USAspending.gov.
The prime grant award recipients report data elements including subaward amount, funding agency, subaward data, and a description of the subaward's purpose. HHS OIG have performed prior audit work related to NIH funding including:
- Most Institutions That Received NIH Funding Did Not Fully Understand When They Must Report Monetary Donations (https://oig.hhs.gov/reports/all/2025/most-institutions-that-received-nih-funding-did-not-fully-understand-when-they-must-report-monetary-donations/)
In addition to previous OIG work, other Federal audits have identified concerns with prime grant award recipient compliance with FFATA reporting requirements, including the accuracy and completeness of the data reported.
With this work plan item, OIG plans to determine whether NIH monitored prime grant award recipients' compliance with requirements for reporting subawards.
Comparing Drug Costs (Medicare v. Veterans Affairs)
According to the OIG, the Department of Veterans Affairs (VA) purchases drugs directly from contracted wholesalers (i.e., the pharmaceutical prime vendor) at prices set through statutory rules and negotiations. However, Medicare, in general, reimburses pharmacies and health care providers for the drugs these entities have already purchased on the open market.
The Congressional Budget Office, as well as the OIG, have found these differences often result in widely different payment amounts for the same drugs with Medicare payments regularly higher than the VA. For example, see https://www.cbo.gov/publication/57007.
Even though Medicare and the VA operate under different statutory restraints with different processes to set prescription drug payment amounts, the fact that different Federal programs may pay vastly different amounts for the same drug has often raised concerns.
With this in mind, the OIG intends for this work plan item to produce a study that will examine how Medicare drug costs compare to the VA's costs for the same drugs.
FDA and Laboratory Safety
The Food and Drug Administration (FDA) operates laboratories to conduct scientific research, including those that handle hazardous biological agents. The Government Accountability Office (GAO) and members of Congress have raised concerns that FDA is not meeting all Federal safety requirements in its laboratory oversight.
For example, the GAO published a report on Laboratory Safety titled, “FDA Should Strengthen Efforts to Provide Effective Oversight” (see https://www.gao.gov/assets/gao-20-594-highlights.pdf) and member of congress have asked the GAO to assess the structure of CDC, FDA, and NIH Lab Safety Offices (see https://energycommerce.house.gov/posts/e-and-c-republicans-ask-gao-to-assess-structure-of-cdc-fda-and-nih-lab-safety-offices).
It appears the HHS OIG will also be performing some examinations of their own. With the addition of this work plan item, the OIG plans to assess the extent to which FDA complied with Federal regulations for laboratory inspections, as well as the extent to which FDA's Office of Occupational Safety and Health has sufficient authority and independence to conduct effective oversight of laboratory safety.
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