OIG Adds Eleven New Work Plan Items for February.

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently issued eleven updates to its Active Work Plan (Work Plan) for February.  When selecting potential projects, the OIG considers legal mandates, congressional requests, budgetary concerns, potential for positive impact, and top management and performance challenges.  The Work Plan outlines ongoing and planned audits and evaluations for the fiscal year and beyond.  The OIG releases the Work Plan items monthly to enhance the transparency of its work planning efforts.  Work Plan items span HHS and involve the Centers for Medicare & Medicaid Services (CMS), public health agencies such as the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH), and human resource agencies such as the Administration for Children and Families (ACF) and the Administration for Community Living (ACL).

The February additions to the OIG Work Plan include the following:

1. Medicare Part D Rebates Related to Drugs Dispensed by 340B Pharmacies

Drug manufacturers often do not pay for Medicare Part D prescription rebates filled at 340B-covered entities and contract pharmacies because the manufacturer already provides a discount on the drug.  The Office of Audit Services (OAS) will conduct a study to determine the potential rebate savings if Part B program sponsors and manufacturers could agree on eligible prescriptions filled at 340B pharmacies that receive rebates.

2. Characteristics of Part D Beneficiaries at Serious Risk of Opioid Misuse or Overdose

A recent OIG data brief found that about 71,000 Medicare Part D beneficiaries were at serious risk of opioid misuse or overdose in 2017.  The Office of Evaluation and Inspections (OEI) will conduct a study to provide information about: 1) the characteristics of these beneficiaries, including their demographics and diagnoses; 2) the opioid utilization of these beneficiaries; and 3) the extent to which these beneficiaries have had adverse health effects related to opioids and any overdose incidents.

3. Ensuring Dual-Eligible Beneficiaries’ Access to Drugs Under Part D: Mandatory Review

Medicare Part D plans that meet certain limitations under 42 CFR § 423.120 have the discretion to include different Part D drugs and drug utilization tools in their formularies.  Under the Affordable Care Act § 3313, the OEI will conduct its annual study to review the extent to which Part D sponsors’ formularies include drugs commonly used by Medicaid and Medicare Part D beneficiaries.

4. Nursing Facility Staffing: Reported Levels and CMS Oversight

CMS uses the Payroll-Based Journal, auditable daily staffing data, to analyze staffing patterns and populate the staffing component of the Nursing Home Compare website (website).  The website helps the public determine the results of health and safety inspections, quality of care at nursing facilities, and staffing, as nursing facilities that receive Medicaid and Medicare payments are required to provide enough licensed nursing services.  The OEI will issue two reports to: 1) describe nursing staffing levels that facilities report to the Payroll-Based Journal; and 2) examine CMS efforts to ensure data accuracy and improve resident quality of care.

5. The NIH Peer Review Process for Evaluating Grants

The NIH Director has expressed program integrity concerns about the NIH peer reviewed grant application process and about grant reviewers inappropriately attempting to influence funding decisions.  The Departments of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (Public Law No. 115-245) and its accompanying report direct the OIG to examine NIH’s grant integrity efforts, which include peer review processes.  Accordingly, the OEI will determine the extent to which certain relevant Institutes or Centers (IC) follow the grant application processes related to scientific review groups (SRG).  The review will also determine how staff and IC directors review the results of the SRGs and develop their funding recommendations for the Advisory Council.

6. The NIH Pre-Award Process for Assessing Grant Applicant Risks and the Post-Award Process for Grantee Oversight

The NIH must determine whether a party is eligible to receive federal funds before it receives a federal reward.  Some eligible parties may be subject to certain conditions because of the risks associated with making federal rewards.  Public Law No. 115-245 directs the OIG to examine the NIH oversight of grantees’ NIH policy compliance, including grant application and selection integrity processes.  The OAS will conduct the NIH IC audits to review the: 1) pre-award process for assessing risk of potential recipients; and 2) post-award process for overseeing and monitoring of grantees based on the identified risks.

7. The NIH Inventory of its Information Technology Resources and Information Systems

All federal agencies, including the NIH, are required to identify Information Technology (IT) resources and maintain an inventory of agency information systems.  IT resources and information systems at the 27 NIH ICs may vary greatly due to specific research priorities.  Pursuant to the Public Law No. 115-245 mandate to review NIH operations, the OAS will determine whether the NIH has complied with applicable IT resource and information systems requirements.

8. The NIH Monitoring of Extramural Researchers’ Financial Conflicts of Interest

The NIH Director voiced concerns about increased risks to intellectual property security in its biomedical research enterprise.  To improve accurate reporting of all financial interests, grantee institutions must submit information that enables the NIH to: 1) understand the nature and extent of a researcher’s financial conflict of interest; and 2) assess the appropriateness of the grantee institution’s plan to manage this conflict.  As directed by Public Law No. 115-245, the OEI will examine the NIH oversight and monitoring of financial conflicts of interest that the grantee institutions reported.

9. The NIH Implementation of Financial Conflict of Interest Regulations

The NIH awards extramural grants to researchers in domestic and foreign organizations.  The grantee institutions are required to safeguard intellectual property derived from NIH-funded research in several ways, including managing financial conflicts of interest and reporting significant conflicts to the NIH.  As directed by Public Law No. 115-245, the OIG must examine the NIH’s efforts to ensure that efforts to protect intellectual property derived from the NIH-supported research are effective.  Accordingly, the OAS will conduct this review to determine whether foreign and domestic grantees disclose all sources of research support, financial interests, and affiliations.

10. Medicare Part B Payments for Podiatry and Ancillary Services

Medicare Part B covers podiatry services for medically necessary treatment of foot injuries, diseases, or other medical conditions affecting the foot, ankle, or lower leg.  This coverage does not cover routine foot-care services unless they are performed: 1) as a necessary and integral part of otherwise covered services; 2) for the treatment of warts on the foot; 3) in the presence of a systemic condition or conditions; or 4) for the treatment of infected toenails.  Evaluation and management (E&M) services are not generally covered when they are provided on the same day as another podiatry service.  However, E&M services may be covered if they are a significant, separately identifiable service.  Podiatrists may also order, refer, or prescribe medically necessary ancillary services.  The OAS will review Part B payments to determine whether podiatry and ancillary services were medically necessary and supported in accordance with Medicare requirements.

11. The NIH and Peer Reviewers: Initial Vetting and Ongoing Oversight

The NIH Director is concerned about an increase in risk to intellectual property, specifically regarding peer reviewers who inappropriately share confidential information in grant applications which undermine peer review integrity.  Public Law No. 115-245 requires the OIG to examine the NIH’s efforts to protect intellectual property derived from the NIH-supported research.  Accordingly, the OEI will conduct a study and issue two reports that assess the NIH: 1) process for vetting prospective peer reviewers; and 2) oversight of peer reviewers beyond the vetting process.

The OIG Work Plan is available at:

https://oig.hhs.gov/reports-and-publications/workplan/index.asp