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The Office of the Inspector General (OIG) is the Federal office, falling under the Department of Health and Human Services, tasked with identifying and eliminating Fraud, Waste, and Abuse (FWA). Most of us are familiar with the concept of Fraud Waste and Abuse and have taken the training numerous times that in the past was required. If we are responsible for credentialing our pharmacies we have attested to that training requirement.
In order to carry out their mission, OIG is also given the authority to "exclude from participation in Medicare, Medicaid, and other Federal health programs persons that have engaged in fraud or abuse and to impose Civil Monetary Penalties (CMPs) for certain misconduct related to Federal health care programs."
What does exclusion really mean?
An excluded provider cannot bill Medicare, Medicaid, or any other Federal program....
1) For their services, or
2) At the medical direction or upon a prescription of an excluded person.
For #1, that includes:
Pharmacy technicians (who cannot assist in the filling of prescriptions)
Pharmacists (who cannot fill the prescriptions)
Cashiers that might ring the customers up
Providers that write prescriptions ultimately filled at the pharmacy.
It's important to note that a health care provider isn't necessarily permanently excluded. It depends on each case. So there are providers out there who have passed their exclusion period and are able to bill for services again.
Types of exclusions
There are two types of exclusions:
Mandatory exclusions require a provider to be excluded for a certain infraction. This includes a felony conviction for healthcare-related fraud, theft, or other financial misconduct. It also includes a range of other offenses, primarily related to either healthcare fraud or to controlled substances.
Permissive exclusions allow, but do not require, a judge to impose an exclusion period on the healthcare provider. In these cases, the provider could be excluded for a number of reasons, including the final decision of the case.
What are the penalties?
If the individual is excluded and participates in any way in providing the services billed for, OIG has the right to recover all money paid out as well as tack on punitive fines.
Healthcare organizations that hire someone on one of the exclusions lists could be forced to pay those penalties. So not checking the databases can pose a serious risk to the organization.
These fines (termed "Civil Monetary Penalties," or CMP) for violating the regulations are steep. Just take a look at this case, cited directly from the OIG website (available here):
"06-20-2017
Florida Pharmacy Settles Case Involving Excluded IndividualOn June 20, 2017, Linton Square Pharmacy & Medical Supplies, Inc. (Linton Square), Delray Beach, Florida, entered into a $339,956.05 settlement agreement with OIG. The settlement agreement resolves allegations that Linton Square employed an individual who was excluded from participating in any Federal health care programs. OIG's investigation revealed that the excluded individual, a pharmacist, provided items or services to Linton Square patients that were billed to Federal health care programs. Senior Counsel Keshia Thompson represented OIG with the assistance of Paralegal Specialist Jennifer Hilton."
What if we didn't know the provider is excluded? Do we have to check all the providers in our database against an exclusion list?
Unfortunately, the answer could be yes; thankfully, there is help out there for that. The pre- and post-edits from your pharmacy switch vendor should screen all prescribers for exclusion and reject the claim if a provider is excluded.
Because it is impractical to screen providers for exclusion (and for plenty of other reasons), I highly recommend you invest in a PPE service with your pharmacy switch vendor if you don't already have one. If you are currently enrolled in one, it is probably worth giving them a call to be sure they offer the same level of provider screening.
What is the Exclusion Screening List?
The OIG Exclusion List Database (LEIE Database)
OIG maintains the List of Excluded Individuals and Entities (LEIE) and updates the list monthly. For this reason, the best practice is to check the online database at hire and then do monthly screenings checks. It is very likely that it is even a law in your state, considering CMS pushed state Medicaid directors 10 years ago to require monthly exclusion checks.
Also, most insurance companies require as part of their credentialing process that the pharmacy attest to checking all staff members within 90 days of hire and then on a monthly basis. Because of the need to attest to doing so, the best thing to do is to have it documented (see below). From my experience re-credentialing pharmacies this attestation is on virtually every application.
State Exclusion Databases
In addition to OIG, state Medicaid programs also maintain their own Medicaid exclusion lists. The majority of states currently have them and, while they are required to coordinate with OIG to communicate changes and prevent billing of excluded individuals, they often don't have adequate procedures in place to do so.
Take a look, for example, at this case where OIG found that Florida Medicaid had paid out $180,416 for services from excluded individuals - and that's just what they were able to find.
OIG and state list of providers won't match, partially because of inadequate communication between them, so it is best to check both databases once monthly.
Where can I find my state database? This article did the work for you and compiled a directory of all state databases as well as provide some additional information.
SAM Database
The System for Award Management (SAM) is used for the Federal procurement (i.e. bidding to do business with the government). If an individual is debarred on the SAM database they are no longer allowed to bid on government contracts.
The OIG issued guidance after receiving inquiries about whether or not both databases needed to be checked by providers for their employees and/or contractors. OIG recommended using LEIE because:
LEIE is maintained and updated monthly by OIG (the enforcing authority for fraud and abuse)
OIG can assist with results on the LEIE and does not have access to SAM
Exclusion does not affect the ability to bid on government contracts
OIG cannot fine (impose CMPs) for employment of a debarred person (assuming, of course, they are not also excluded)
For these reasons (among others listed by OIG) the focus should be on the LEIE and state databases, and not on the SAM database.
How do I check the databases?
While simple to do, it is a best practice to have documentation that all employees have been checked at hire and on a monthly basis afterwards.
Unless there are numerous employees (like within a chain or independents with numerous locations - see Method 2) it isn't going to take any more than 15-20 minutes per month to complete.
The easiest way to check it in-house, and ensure you get the federal and state databases, is to use VerifyComply's free portal service. It will screen both federal and state databases and also keep a record of your searches, providing the documentation you need.
If you prefer to check the databases directly (note: not recommended), here's how to check the OIG database. You'll need to find your state database as well and check it separately.
Step 1. Go to the OIG Exclusions Database (also listed in the helpful links section).
Step 2. Enter each employee name in the search field. It is easiest to use the 'Multiple Individuals' option above to enter as many as five employees at a time.
Step 3. If their name does not populate in the results they are not excluded from the program. It is OK for them to continue employment at the pharmacy.
Step 4. If their name does populate in the results they are excluded from the program and cannot work. Being on the OIG exclusions list is cause for
Retraction of an offer letter or
Immediate suspension/termination, depending on whether or not the issue can be resolved.
Also, if you do discover an individual that has been employed while being excluded, it is best to voluntarily disclose that information to OIG to avoid the additional costs and disruptions of a Federal investigation. OIG provides information and direction on self-disclosure here.
Step 5. Repeat Steps 1-4 for your state database(s), if applicable.
Step 6. Using the PCS template, if the employee is not excluded from any of the database(s) write "NO" for that employee and month and initial it. Each template can hold one year's worth of data:
For a single pharmacy location, the exclusions can be kept either in a folder or in the compliance binder.
If the company has multiple locations, it is best to have this task performed by the regional or main office, where it can be filed or stored in the regional office compliance binder.
Doing so provides several advantages:
Prevents staff that are responsible for dispensing to 'check for themselves' on the exclusions database,
Will ensure consistency across all locations for both hiring and monthly checks, even in the case of manager turnover, and
Will allow the company to more quickly identify individuals if they do become excluded.
There has to be an easier way, doesn't there?
Yes!
You can also hire the exclusion list screening out and have it automated, so you don't have to touch it at all.
My suggestion would be to consider doing it manually if you have a small staff and one location (many pharmacies start out with just themselves or just one other technician, for example).
As your business grows, however, it will not only get more time-consuming to do yourself but you will also need that time even more to run your business and go between locations. At that point it can make a lot of sense to let someone else manage the exclusions.
Verify Comply's Portal Pro offers numerous advantages to attempting to do it yourself, including:
Searching both individuals and entities
Federal and state database checks
Automated documentation each time the databases were checked
A user-friendly, web-based dashboard
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References (not otherwise linked within this article):
From the Office of Inspector General:
Background: https://oig.hhs.gov/exclusions/background.asp
Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs: https://oig.hhs.gov/exclusions/files/sab-05092013.pdf
Keywords: SAM, OIG exclusion list, CMS, LEIE, fraud waste and abuse, FWA
