The complex web of regulation encompassing government health care dollars is a lot to take on. With 41 state exclusion lists and several federal lists, it can be difficult to know which exclusion lists to screen, let alone actually screen them all. Each government payor of healthcare dollars has a different set of rules on who is allowed and who isn’t allowed to bill their services. Healthcare providers are not legal experts, nor should they have to be. Rather than taking the risk of non-compliance, we break down exclusion regulations for you and explain which exclusion, sanction, debarment, or termination list you must check as a healthcare provider.
I. What is an Exclusion?
Exclusions are a final administrative action that is intended to protect the financial integrity of health benefit programs and beneficiaries by removing individuals and entities that pose a risk to them. While a party does have the right when noticed that they are about to be excluded, as a final administrative action, once excluded there is no further appeals process.
II. Impact of Exclusions
An exclusion is the nuclear bomb of administrative actions. As a result of an exclusion, a payment prohibition is enforced. Federal and State programs will not pay or items or services furnished, directly or indirectly, by excluded entities. In essence, the government has decided that they do not want programs to pay for the overhead or salaries of excluded parties. Therefore, to comply with exclusion regulations it is best to screen all employees, contractors, vendors and even volunteers.
III. Scope of the Payment Prohibition
The payment prohibition extends to anyone who has an effect on patient care. This extends to all services connected to a practice, including but not limited to:
- Billing, Claim Processing, and Accounting Services
- Leadership, Management, Administrative, and Strategic Services
- Human Resource and Information Technology Services
- Transportation Services – including drivers and dispatchers
- Even volunteers if their activities contribute to a bundle of services
IV. Where are exclusions listed? How many exclusion lists are there?
Exclusion Screening recommends for best practice to screen against two Federal Exclusion lists, and 41 state lists. The primary healthcare exclusion list is the OIG/LEIE. Together with the GSA SAM, previously known as the EPLS, the LEIE, and the SAM make up the two Federal Exclusion Lists. While the GSA/SAM is not a healthcare-specific list, it is a federal debarment list and any party on it cannot enter into any federal contract.
While screening these lists are best practice, there are many more exclusion lists such as the CMS Preclusion list, OFAC, and SDN, among others. Depending on your organization’s payors, contracts, or state requirements you may have to screen more than our recommendation.
V. Screening Obligations for Fee for Service Medicare
The Department of Health and Human Services, Office of Inspector General (OIG) maintains the List of Excluded Individuals and Entities (LEIE). This is considered the most comprehensive of all exclusion lists, with over 70,000 names on it. At a minimum, the OIG-LEIE must be checked to participate in the Fee for Service Medicare.
However, checking only this list opens an entity up to risk. This is because although every state is required to send their exclusions-for-cause to the OIG, some states are slow to do so and often miss sending some parties. As a result, the OIG-LEIE is missing several excluded parties. Despite the OIG missing these parties on their list, an entity is still liable if they screen the LEIE and hire the party. For this reason, it is also important to check state-level exclusion lists.
VI. Screening for Medicare Advantage Providers
Medicare Advantage providers have unique screening requirements. They must screen both the OIG/LEIE and the CMS Preclusion list. Medicare Part C and Part D Plan Sponsors are unique because they are the only group of providers that must screen the Preclusion list and are the only ones to have access to the list (the Preclusion is not public).
The list differs from the OIG/LEIE because, unlike the OIG/LEIE, the Preclusion List does not require a final action for a party to be added to it. If there is a basis for revocation, such as participating in conduct that COULD result in revocation, whether or not the revocation happens, a party may be put on the preclusion list. While Medicaid Advantage Providers are the only ones to have access to the CMS Preclusion list, they may delegate screening of the list to a third party such as Exclusion Screening. (Read more about the preclusion list here)
VII. Screening Requirements Imposed by State Medicaid Programs
Most states have two different sets of screening requirements. The “Basic” screening requirements flow from letters issued by CMS to each state Medicaid director mandating monthly exclusion screening by Medicaid providers. This requires screening of the OIG/LEIE, the state exclusion list (if there is one), and some states have state-specific lists that must be searched (i.e. sex-offender list, elder abuse list).
Additional requirements are associated with Provider Agreement and Reenrollment forms. These contain significant disclosure and verification requirements. However, there is no consistent standard between the states. For example, as part of the Texas Medicaid participation agreement, a provider must check ALL states and federal databases and certify, under penalty of perjury, that none of their employees, contractors, and vendors are on them. While in Louisiana a provider must certify that no employee, vendor, or contractor has EVER been excluded from ANY program. Although many state requirements do not explicitly say what must be screened, how could a provider give an honest answer and protect themselves from perjury without screening all exclusion lists.
A map of states with their own exclusion list (in red) can be found below.
VIII. Medicaid Advantage Care Screening Requirements
Medicaid Managed Care Plans may not work with any of the following to provide, directly or indirectly, “the administration, management, or medical services o
r establishment of policies or provision of operational support for such services.”
- Any individual or entity that is (or affiliated with a person or entity that is) debarred, suspended, or excluded from participating in procurement activities under the Federal Acquisition Requirement (FAR) or,
- Any individual or entity that is excluded from participation in any Federal healthcare program…
To ensure that your organization is complying with the FAR regulation, it is important to screen against the GSA/SAM, as well as the OIG/LEIE and the 41 state exclusion lists.
IX. Enforcement Mechanisms
OIG’s Civil Money Penalties Authority for Exclusion-Related Violations:
It is important to remember that each of these Civil Money Penalties is for each offense. A provider who has worked with an excluded party can quickly rack up several offenses with each claim submitted to a health benefits program.
Failure to screen can also result in False Claims Act liability. While a provider must “knowingly” hire an excluded party to be open to False Claims Act liability, “knowingly” by statute includes reckless disregard or deliberate ignorance, such as not doing exclusion screening.
A. Additional Consideration #1: Almost Every Risk Area is Directly Related to Employees or Contractors
Human capital is the heart of your practice, but also is the biggest risk in your organization. Any plan to lessen risk needs to start with ensuring that all employees and contractors are screened.
B. Additional Consideration #2: Screening is part of an effective compliance plan
As of 2017, the OIG has included “screening and evaluation of employees, physicians, vendors, etc.” as part of the seven elements of an effective compliance plan. The OIG views screening as an important step to mitigate risk.
C. Additional Consideration #3: Exclusions show up on different lists at different times. And sometimes not on lists you expect.
When states take an exclusion action they are supposed to report it to other states and the OIG so they can be added to other lists. However, it doesn’t always happen. Even the OIG/LEIE, the biggest list of them all, doesn’t have all exclusion records. It is important to remember that as public knowledge, a provider is presumed to know if any employees or contractors are on ANY of the exclusion lists. Screening only the OIG/LEIE is not enough and will not shield a practice from liability.
D. Additional Consideration #4: Can Failure to Screen be Excused?
Imagine this, an accident or incident resulting in patient harm or financial loss to the practice occurs and the harm was caused by or related to an employee on one of the exclusion lists. A judge or jury would have no sympathy for the practice that failed to screen. There is no excuse not to screen all State and Federal exclusion lists.
X. Final Thoughts
Screening the OIG-LEIE, GSA-SAM, and the 41 State exclusion lists is not only good business practice, it is essential to protecting your organization from legal implications. At Exclusion Screening, LLC. we provide a simple, automated, and cost-effective solution to the complexity of monthly screening of over 40 exclusion lists. We use the sophisticated algorithms in our SAFER system to screen all lists, including variations of individual names, to ensure your organization complies with exclusion screening obligations.
We can be reached at 1 (800) 294-0952, articles@exclusionscreening.