Since healthcare is directly responsible for the safety and wellbeing of the public, it’s obvious then why there are so many stringent regulations that impact businesses in this field.
Governments and regulatory bodies want to ensure that any drug, treatment, and other medical service provided by hospitals and research organizations are both safe and effective. Keeping those objectives in mind will help grow a base of satisfied customers, boosting the bottom line.
To that end, many government agencies publish a list of exclusions, which are defined as companies and individuals that medical firms must avoid working with (also known as denied or restricted parties). Among those lists is the Office of the Inspector General (OIG) exclusion list, and any hospital operating in the country must screen for these excluded parties to stay compliant with medical regulations.
Why Does Screening against the OIG Exclusion List Matter?
Legal compliance matters in the healthcare industry, and businesses here are incentivized to follow along because of several factors:
- Monetary fines: Known as civil monetary penalties (CMPs), government agencies have been well known to enact enforcement action against non-compliant businesses.
- Reimbursements: Working with excluded parties can cause you to overpay when receiving reimbursements from federal healthcare programs.
- Safety: Entities are banned for a good reason. Whether they are employees you might hire or a third-party vendor you might purchase from, these entities are deemed a risk and can compromise on the safety and effectiveness of your products or services, potentially putting your patients at risk, if you choose to work with them.
Exclusion screening matters immensely for the pharmaceutical industry since hospitals have to work with a large number of vendors and distributors and hire plenty of physicians and staff all the time. The chance of running into a risky entity is high, especially as the institution grows and begins operating internationally.
What is the OIG exclusion list? The OIG maintains the List of Excluded Individuals and Entities (LEIE), which lists out all the individuals and organizations banned from federally funded healthcare programs. The OIG doesn’t stand alone, however. There are other exclusion lists to consider, but we’ll discuss those later in this article.
Why Are Entities Added to the List?
Entities engaging in unethical, or worse, behavior are at risk of being excluded by the OIG. The exclusion can be mandatory, that is immediately required by law, or permissive, where it’s up to the discretion of the OIG. Either way, certain breaches of the rules can put you on the federal OIG exclusion list, such as:
- History of patient neglect or abuse
- Distribution or production of controlled substances
- Fraudulent use of Medicare or Medicaid
Once on the list, entities cannot receive payments for services through federal healthcare programs, though they may still be able to receive benefits from those programs in some cases.
How Do You Screen Against the OIG Exclusion List?
It’s up to the hospital itself to make sure that it isn’t working with banned parties. OIG exclusion screening is the practice of cross-checking your staff members and third-party partnerships for the presence of barred entities.
For instance, any new vendor you start purchasing from or any physician you hire must have their names checked with the LEIE databases to verify compliance. The online version of the LEIE list is available for businesses to use for this purpose. You can search by name, Social Security Number, Employer Identification Number, and other methods.
Theoretically, healthcare companies could screen against the OIG exclusion list manually, but this can become cumbersome since these lists are continually updated, meaning that the screening work has to be undertaken at a regular cadence. The other challenge is that there are more than one list to screen against. Forward thinking organizations rely on robust software solutions providers to help them meet compliance requirements. And because risk is mitigated, they are able to deliver quality products and services to their customers, which in turn enables growth.
LEIE vs. SAM
The OIG Exclusion List isn’t the only regulatory body you must pay attention to. Medical compliance involves checking the exclusion lists from other agencies as well, such as the Office of Foreign Assets Control and the Drug Enforcement Administration.
One of the major ones is the System for Award Management (SAM) from the General Services Administration (GSA), part of whose aim is to fight fraud in the healthcare sector. SAM is actually an evolution of the previous Excluded Parties List System (EPLS).
While both SAM and LEIE share the same purposes, they are handled by two separate organizations. To a hospital, that means two lists to keep track of simultaneously when working with third parties and hiring new physicians and staff.
Achieve International Trade Compliance Easily
With so many exclusion lists to keep track of, it can be complicated maintaining a consistent compliance program for your healthcare business. That’s why entire services have been established to help out.
Set up your free demo with Descartes today to start scanning your doctors, vendors, and third-party partnerships with ease. Making sure no exclusion is left out is the best way to avoid costly government actions, fines, and reputational damage.
For more comprehensive information about effective compliance in the healthcare industry, download our white paper or visit our Resource Center.
How Descartes Can Help
Get started with Descartes and screen against the OIG exclusion list, as well as a myriad other mandatory lists, to help make sure you are not inadvertently entering into a business transaction with a banned entity.
To help manage compliance risks more effectively, Descartes provides a range of robust denied party screening and 3rd party risk management solutions as well as comprehensive and trusted trade content for leading business systems such as SAP, Oracle, Salesforce and Net Suite to name a few.
Descartes compliance solutions are flexible and modular, allowing organizations to pick the specific and exact functionality and content they need and scale up later as and when necessary. By utilizing these solutions, organizations can strengthen their compliance processes, enhance their competitive edge and increase sales velocity.
To learn more about how Descartes Visual Compliance and Descartes MK Denied Party Screening can help you stay on top of the latest sanctions, please click here and here.