Category Archives: Exclusion

Don’t Let CMS Add You to Its Lists

Have you received a letter from the Department of Health and Human Services (“DHS”) or the Centers for Medicare and Medicaid Services (“CMS”) informing you that they intend to exclude you from one or more federal payors (e.g., Medicare) or that they intend to add you to their preclusion list? If so, you need to act timely and appropriately to ensure you protect your rights. Being excluded or precluded from federal payor programs can have long-lasting consequences, both directly with the federal government and with the State of Florida.

What is Exclusion?

Exclusion applies to people and entities who participate in any federal payor programs, such as Medicare, Medicaid, Tricare, or other reimbursement programs funded by the federal government. Exclusions are governed by 42 U.S.C. § 1320a–7. This statute sets forth 21 reasons that DHS or CMS can use as a basis for exclusion from participation in federal payor programs. These reasons range from things like having a criminal conviction related to patient abuse or being a part of prohibited kickback scheme to failing to make adequate disclosures or defaulting on student loans.

Once an individual or entity is excluded, they will be added to the List of Excluded Individuals/Entities (“LEIE”) which is publicly available here. Exclusion also prohibits any other health care entity that is participating in a federal payor program from employing the excluded individual in any position involving management, administration, or patient care services. As a practical matter, most health care institutional providers such as hospitals, nursing homes, and other large companies will not employ individuals who are on the federal exclusion list.

The length of the exclusion will depend upon the reason for the exclusion, any aggravating factors, and any mitigating factors. For example, exclusion due to an individual’s criminal conviction related to patient abuse mandates a statutory five-year minimum exclusion (unless certain exceptions are met).

What is Preclusion?

Preclusion is similar to exclusion in that it bars an individual or entity from participating in the Medicare Advantage program. Thus, private insurers and managed care plans are precluded from paying individual practitioners on the preclusion list for services provided to their Medicare Advantage Plan enrollees. Further, unlike exclusion, preclusion extends its reach to include individual health care providers who may not even be enrolled in any federal payor programs. For example, a physician who is not enrolled in Medicaid or Medicare but has a contract with a private Medicare Advantage insurance plan may still be placed on the preclusion list, preventing payment for patients who have that insurer. The grounds for being added to the preclusion list are set forth in 42 C.F.R. § 422.2 and include reasons such as being excluded from Medicare and having a felony conviction in the past 10 years that CMS “deems detrimental to the best interests of the Medicare program.” Like exclusion, the length that an individual or entity can be placed on the preclusion list vary based on the details and the reason for being placed on the list. For example, a person placed on the preclusion list due to a felony conviction will be placed on the preclusion list for a “10-year period, beginning on the date of the felony conviction.” 42 CFR § 422.222(5).

Unlike exclusion, the preclusion list is not publicly available for viewing. However, CMS will notify private insurers informing them that an individual or entity was added to the preclusion list – which will almost inevitably lead to that individual or entity having those private insurance contracts cancelled.

The Importance of Timely and Fully Responding to a Notice

Preclusions and exclusions can have wide-reaching, long lasting consequences. In addition to the immediate effect – not being able to bill to the federal payor(s) at issue – being precluded or excluded can affect your ability to participate in Florida’s Medicaid program and can cause private insurers to cancel their contracts.

Beyond the payor issues, this can also affect your professional/facility license. See e.g., Florida Statute § 408.815(1) (providing for the revocation and/or denial of a renewal license for a health care facility that is “currently excluded, suspended, or terminated from participation in the state Medicaid program, the Medicaid program of any other state, or the Medicare program.”).

Due to these wide-reaching consequences, it is important that you timely and fully respond to any notice informing you or your facility that they may be excluded or precluded. Timely responding is a strict requirement. Failure to timely respond will almost always constitute a waiver of your right to challenge the preclusion or exclusion. Further, your response needs to include ALL of the information, defenses, and arguments you intend to make. Failure to raise an issue can constitute a waiver of that issue later in your appeal.


Being added to the LEIE or Preclusion List is a serious issue that can haunt you and your career for a long-time. If you have been informed that DHS or CMS seeks to add you to either of these lists, you should contact an attorney at Smith & Associates to discuss your rights and options.