We get it - OIG exclusion screening feels like one more checkbox in an endless compliance to-do list. But skipping it, even for a month, can have consequences that make every other compliance issue look minor. This month, we are talking about what actually happens when pharmacies fail to screen, with real enforcement examples and a workflow that takes the pain out of the process.
Regulatory Update: OIG Updates LEIE Database and Screening Guidance
The Office of Inspector General updates the List of Excluded Individuals and Entities (LEIE) monthly, and recent additions have included pharmacy technicians, pharmacists, and pharmacy owners. The OIG has also published updated guidance emphasizing that healthcare entities participating in federal healthcare programs must screen all employees and contractors - not just clinical staff - against the LEIE and the GSA System for Award Management (SAM) exclusion database.
This means your delivery drivers, your billing staff, your IT contractors, and anyone else who has a role in providing or supporting items or services billed to federal healthcare programs must be screened. If you have been limiting your screening to pharmacists and technicians, expand your scope now.
What Actually Happens When You Employ an Excluded Individual
Here is the part that should get your attention. Under the Civil Monetary Penalties Law, if your pharmacy employs or contracts with an individual or entity excluded from federal healthcare programs, you can face penalties of up to $100,000 for each item or service furnished by the excluded individual and billed to a federal healthcare program. On top of that, you face treble damages (three times the amount claimed) and potential exclusion from federal healthcare programs yourself.
That is not a theoretical risk. In one enforcement action, a healthcare provider was required to pay over $150,000 in penalties and damages after employing an excluded individual for just eight months. The provider claimed they did not know the employee was excluded. The OIG response was clear: it is your responsibility to check.
The math is straightforward. A pharmacy technician processes dozens of prescriptions per shift. If even a fraction of those are billed to Medicare or Medicaid, and the technician is on the exclusion list, every single one of those claims becomes a potential penalty. A few months of missed screening can turn into millions of dollars in liability.
This is not about catching bad actors in your pharmacy. It is about protecting yourself from a liability you did not know existed. People end up on the exclusion list for reasons that may not be obvious - a previous employer's fraud, personal legal issues, licensing problems. Monthly screening catches these situations before they become your problem.
HIPAA Connection: OIG Screening and Workforce Records
When you screen employees against the LEIE and SAM databases, you are handling personal information - names, dates of birth, Social Security Numbers in some cases. This data needs to be protected.
Store screening results in secure, access-controlled files. Limit access to your compliance officer or the person responsible for screening. When documenting results, you do not need to retain the full search output for individuals who are not found on the exclusion list - a log entry showing the person screened, the date of screening, the databases checked, and the result (no match found) is sufficient. For any potential matches, retain the full search results and your resolution documentation.
If you use a third-party screening service, confirm you have a BAA in place if the service will be accessing or storing any protected health information as part of the screening process.
Building an OIG Screening Workflow That Actually Works
The reason pharmacies skip OIG screening is not that they do not care - it is that the process is manual, time-consuming, and easy to forget. Here is how to fix that.
First, designate one person as responsible for monthly screening. This should not be a shared responsibility, because shared responsibility is no responsibility. Assign it, put it in their job description, and hold them accountable.
Second, set a recurring calendar event for the first business day of every month. When the reminder fires, the designated person screens every individual on your workforce list against both the LEIE (at oig.hhs.gov) and SAM (at sam.gov). This includes employees, contractors, relief pharmacists, cleaning services - anyone connected to your pharmacy operations.
Third, document everything in a screening log. The log should include the date of screening, the name of every individual screened, the databases queried, the result, and the name of the person who performed the screening. Keep this log for at least seven years.
Fourth, screen new hires before their start date, not on their first day, not during orientation - before they walk in the door.
Or, use a tool that automates all of this. Rxperts includes built-in OIG screening tools that check both LEIE and SAM, flag potential matches, and maintain a complete audit trail. If you are still doing this manually, consider whether the time savings alone justify the switch.
Quick Hits
- Verify your screening scope includes ALL workforce members, not just clinical staff
- Check that screenings have been completed every month for the past 12 months
- Confirm new hires are screened before their start date
- Review your screening log for completeness - dates, names, databases, results
- If using a third-party screening service, ensure a BAA is in place
- Consider automating your screening process to eliminate missed months
Stay compliant. Stay ahead. - The Rxperts Team