OIG Updates That Might Impact Your Organization: NIH, Vaccines, and Grants

December was a time of gift-giving for many. And the OIG gave us some new gifts by way of their Work Plan. Let’s take a closer look at the December additions.

Telehealth Services

It should not come as a surprise that the OIG is interested in compliance with telehealth services.  The pandemic is still in full force, and telehealth services have been on the rise.  Telehealth services are vital during pandemics.  These services allow for patients to be evaluated while reducing the potential exposure of others to COVID.  Mainly because of the pandemic, telehealth services’ requirements have been adjusted. Because the pandemic is still a significant health concern, additional questions arise about how telehealth services can provide other benefits.

The government created a Pandemic Response Accountability Committee (PRAC).  This committee will produce a report describing the types of telehealth services, including the expanded services during the pandemic.  The OIG from HHS will be working with OIG members from other departments such as Defense, Justice, Labor, and Veteran Affairs.  The report will also include key program integrity risks associated with telehealth services.  The report intends to offer “policymakers and stakeholders with foundational information about the nature of telehealth across select Federal healthcare programs and related program integrity risks to inform the use of telehealth in the future.”  The expected issue date of this report will be 2023.

NIH Awards

The National Institute of Health runs an awards program called the Small Business Innovation Research (SBIR) program.  This program is designed to assist small businesses, particularly in federal research and development. Certain federal agencies with a research budget exceeding a certain amount must allocate a percentage of that budget to fund small businesses through the SBIR program.  Within HHS, the NIH makes up 98% of the total funds, which was $4.6 Billion for four years.

A small business that wants to participate in the SBIR must meet specific requirements, such as:

• • the business must be organized for-profit with a place of business located in the United States
  • be more than 50 percent owned and controlled by U.S. citizens
  • and have fewer than 500 employees.

The OIG has concerns about certain “areas of potential risk regarding for-profit organizations receiving SBIR awards such as inappropriate or unsupported charges to Federal awards, deficiencies in internal controls related to financial management systems, and eligibility of organizations to participate in the SBIR program.”

Congress also has concerns about fraud, waste, and abuse risks in the SBIR program. This OIG Work Plan item is intended to determine whether selected SBIR awardees complied with Federal requirements. Depending on what the OIG finds, they may conduct additional audits of high-risk SBIR awardees following this review.

Vaccines for Children (VFC) Provider Site Visits

The federal government funds a no-cost vaccine for children program called Vaccines for Children, or VFC.  The Centers for Disease Control and Prevention (CDC) has responsibility for running this program through policies and implementation.  The CDC also purchases the vaccines and distributes them to participating providers.  For example, these may include private physician offices and public health clinics.

Entities that granted these vaccines must conduct certain activities to ensure the program’s integrity.  Some of these requirements include:

1. 1. An enrollment site visit for all new and re-enrolling VFC providers before receiving VFC vaccines.
   2. Compliance site visits for all enrolled and active VFC providers every 24 months
   3. Unannounced storage and handling site visits at a minimum of 5 percent of VFC providers during the cooperative agreement budget period

The OIG plans to audit whether CDC VFC grantees conducted site visits at enrolled and active VFC program providers that provide routine childhood vaccines.

Conclusion

If your organization is involved in any of the mentioned activities, it might be beneficial to review these areas yourself proactively.  There are additional items that have been added to the Work Plan.  Make sure to check the list in its entirety here.

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