Each month, we are pleased to share the most recent additions to the HHS Office of Inspector General (OIG) Work Plan items. HHS OIG updates its Work Plan monthly with new changes to the active list. Let’s take a look at the new updates from this month.
What is the OIG Work Plan?
The HHS OIG Work Plan sets forth various projects that OIG plans to undertake during the fiscal year (FY) and beyond. Projects listed in the Work Plan span HHS’s operating divisions, including the following:
- Centers for Medicare & Medicaid Services (CMS)
- Public health agencies such as the Centers for Disease Control and Prevention (CDC)
- National Institutes of Health (NIH)
- Administration for Children and Families (ACF)
- Administration for Community Living (ACL)
- Various state and local governments – evaluating the use of federal funds as well as the administration of HHS
*Some of the projects described in the Work Plan are statutorily required.
The August agenda includes six new items from HHS Office of Inspector General (OIG). Let’s walk through this latest release so you can address it within your compliance program, if applicable.
- Review of the Food and Drug Administration’s Contract Closeout Actions
- Medicare Advantage Organizations’ Use of Ordering Provider Identifiers for Program Integrity Oversight
- NIH-Funded Clinical Trials Reported to ClinicalTrials.gov
- COVID-19 Testing Data From Federal Programs
- Infection Control at Home Health Agencies During the COVID-19 Pandemic
- HHS and ASPR Actions Related to Resources, Supplies, and Treatments Needed to Address COVID-19
Review of the Food and Drug Administration’s Contract Closeout Actions
HHS, one of the federal government’s largest contracting agencies, delivered close to $26.5 billion in awards and modifications in the 2019 fiscal year. Previous OIG work identified contract closeout issues, which is required once evidence that all terms and administrative actions have been met, disputes settled, and the final payment has been made. The closeout process allows for a final window to detect improper contract payments and can also ensure the following:
- Goods and services were provided
- Validation of final costs and payments
- Excess funds are available for possible use elsewhere
OIG will determine whether the Food and Drug Administration (FDA) closed contracts in accordance with the Federal Acquisition Regulation and departmental guidance while also determining whether they identified contracts at the time of closeout eligibility.
Medicare Advantage Organizations’ Use of Ordering Provider Identifiers for Program Integrity Oversight
Used as unique identification numbers for covered healthcare providers, National Provider Identifiers (NPIs) improve the efficiency and effectiveness of electronic medical information communication. Although CMS does not require Medicare Advantage organizations (MAOs) to collect NPIs for ordering providers, they are crucial in protecting durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS), clinical laboratory services, imaging services, and home health services.
OIG found that nearly two-thirds of Medicare Advantage encounter data records did not include NPIs. However, many MAOs do collect NPIs and have the capability to do so. OIG recommended that CMS require MAOs to submit ordering provider identifiers. This issue brief will determine the extent to which MAOs conduct oversight of DMEPOS, clinical laboratory services, imaging services, and home health services using ordering provider identifiers.
Easily Search for a Provider by NPI
NIH-Funded Clinical Trials Reported to ClinicalTrials.gov
The National Institutes of Health (NIH) provides funds to awardees to conduct clinical trials involving human subjects. These trials are intended to assess the effects of FDA regulated drugs or medical devices and evaluate non-FDA regulated interventions. Clinical trials are essential to medical progression because they test new and existing health-related interventions and help us understand the safety and effectiveness of interventions.
Results from the trials foster improved patient safety by:
- Giving doctors, researchers, and the public at large access to information that may inform medical decisions
- Help focus on areas in need of study
- Maximize the public’s investment—and trust—in research
Federal law, regulations, and NIH award terms and conditions generally require NIH awardees to submit trial results to NIH within one year from the completion date. NIH has now prolonged this requirement to all NIH-funded clinical trials. As NIH is required to post these trials’ results on Clinical Trials.gov within 30 days of receiving them, OIG will conduct an audit to determine whether NIH ensured that awardees followed these Federal reporting requirements.
COVID-19 Testing Data From Federal Programs
The Pandemic Response Accountability Committee (PRAC), created by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, promotes clarity and supports the coordinated oversight of the federal government’s Coronavirus response. PRAC members include Offices of Inspectors General (OIG) at federal agencies who may operate, utilize, or are otherwise impacted by healthcare programs.
Within PRAC, the Health Subgroup has identified significant risk areas, including COVID-19 testing, critical to the federal government’s response efforts.
PRAC’s Health Subgroup includes OIGs from the:
- Department of Defense (DOD)
- Department of Education
- Department of Health and Human Services (HHS)
- Department of Labor (DOL)
- Department of Veterans Affairs (VA)
- Office of Personnel Management (OPM)
Collaboratively HHS OIG and PRAC will produce a data brief describing COVID-19 testing in federal health-related programs managed or operated by DOD, DOL, DOJ, HHS, OPM, and the VA. This will provide clarity and inform policymakers about COVID-19 testing resources in federal programs.
Infection Control at Home Health Agencies During the COVID-19 Pandemic
With the coronavirus being incredibly dangerous for adults 65 years and older and for those with underlying medical conditions, Medicare beneficiaries receiving home health services (skilled nursing care, physical therapy, speech-language pathology, occupational therapy, and receiving medical supplies) are at a high risk of developing severe illness from COVID-19.
As a covered Medicare/Medicaid service for the elderly and disabled, home health service agencies (HHAs) must meet specific requirements, such as infection prevention and control standards.
On March 10, 2020, CMS issued a State Survey Director’s Letter, “Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Home Health Agencies (HHAs),” to help HHAs address the outbreak and minimize transmission.
We will interview corporate officers from the three HHA providers with the largest market share in 2019, plus HHAs recently cited by CMS for infection control and prevention deficiencies. These interviews will determine the extent to which their infection control and prevention policy and procedures comply with CMS guidance regarding COVID-19.
HHS and ASPR Actions Related to Resources, Supplies, and Treatments Needed to Address COVID-19
HHS may take action in response to rising infectious diseases, including actions linked to resources, supplies, and treatments needed to address COVID-19. This study would examine HHS’s actions, including the Office of Assistant Secretary for Preparedness and Response, to protect the public’s health during the COVID-19 pandemic.
There’s no doubt that COVID-19 has exposed the vulnerabilities of healthcare supply chains and the scarce supply of critical resources for an emergency response such as PPE. Going forward, we believe that new protocols will be necessary to evaluate the future of PPE acquisition and supply chain standards.
Find the full list of Recently Added Items on OIG’s site.
Take a look at our recaps of all the archived releases by visiting the ProviderTrust Work Plan page.