(October 8, 2019): On April 16th, 2018, the Department of Health & Human Services (HHS), Centers for Medicare and Medicaid Services (CMS), issued a Final Rule entitled, “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program.”  This 300+ page issuance revised the Medicare Advantage program (Part C) regulations, along with the Prescription Drug Benefit program (Part D) regulations, in order to implement portions of the Comprehensive Addiction and Recovery Act (CARA). Among its various provisions, the Final Rule also served to rescind existing regulations that required prescribers of Part D drugs and providers of Medicare Advantage services and items to enroll in Medicare Fee-for-Service in order for the Part D drug or Medicare Advantage service or item to qualify for coverage and payment. In lieu of the enrollment requirements, CMS now requires that a Part D plan sponsor reject a pharmacy claim for a Part D drug if the provider prescribing the drug is included on a “Preclusion List.” Similarly, if a health care provider or supplier is listed on the preclusion list, no services furnished (or items supplied) by that individual or entity will be covered by Medicare Advantage. At the time, CMS estimated that these changes would reduce program costs by $34.4 million in 2019.
A year to the day after publishing the Final Rule covering the Preclusion List, CMS published a Final Rule revising the Medicare Advantage (Part C) and Prescription Drug Benefit Program (Part D) regulations on April 16, 2019. The April 2019 Final Rule made a number of revisions to the Preclusion List provisions set out in the April 2018 Final Rule. This article examines the CMS Preclusion List in more detail and examines the impact of a provider, supplier and / or prescriber being placed on the list.
I. What is the CMS Preclusion List?
Simply stated, the CMS preclusion list is a register of all health care providers, suppliers, and prescribers who are precluded from receiving reimbursement for Medicare Advantage items and services or Part D drugs that are provided or prescribed to Medicare beneficiaries. CMS has established the preclusion list in an effort to better ensure patient safety and to protect the integrity of the Medicare Trust Funds from the actions of providers and prescribers that have been identified as “bad actors.”
CMS is responsible for maintaining the Preclusion List. The list is made available to Medicare Advantage and Part D payor plans. If a Medicare Advantage receives a claim for a health care item or service that was furnished by a precluded party, the claim will be denied. Similarly, if a Part D payor plan receives a claim for reimbursement from a pharmacy or Medicare beneficiary that is related to a drug that was prescribed by a precluded individual, the claim will be denied.
II. What is the Difference Between an “OIG Exclusion” and a “CMS Preclusion” Action?
While based on completely different statutes, both the exclusion and preclusion regulations are intended to protect that safety of Medicare, Medicare and Federal health care beneficiaries AND help safeguard the financial integrity of Federal and State health care programs. What is the difference between the two programs?
- Medicare OIG Exclusion. The OIG is responsible for administering the various mandatory and permissive exclusion authorities that have been enacted. If a health care provider, supplier or other entity is “excluded” from participation in the Medicare or Medicaid programs, the excluded party cannot provide care or services to Medicare and / or Medicaid beneficiaries. Moreover, an excluded party cannot work for a participating provider. Nor can an excluded party serve as an agent, contractor, or vendor for a participating provider or supplier. In my opinion, the definitive analysis of the OIG’s exclusion regulations is covered in Paul Weidenfeld’s article entitled, “Federal Exclusion Regulations and Enforcement Authorities, and How Providers Can Avoid Risk with Proper Exclusion Screening.” 
Broadly speaking, an individual or entity is typically excluded from participation in the Medicare or Medicaid programs due to a criminal conviction, the abuse of a patient, and / or an adverse licensure sanction. In contrast with the preclusion regulations set out the updated Final Rule dated April 16, 2019, the exclusion regulations were first mandated by Congress in 1977 as part of the “Medicare-Medicaid Anti-Fraud and Abuse Amendments, Public Law 95-142.”
If an individual or entity (typically a health care provider, supplier) is excluded from Medicare or Medicare, the identity of the excluded party is posted online and is publicly available on the on OIG’s “List of Excluded Individuals/Entities” (LEIE) and / or one the 41 State Medicaid exclusion databases that are currently maintained around the country. Finally, the effect of an exclusion action applies across the board. It applies to services and items covered by traditional Medicare program, Medicare Advantage (Part C), and Part D drug plans.
- Medicare CMS Preclusion. In contrast to the Medicare exclusion authorities which are administered by the OIG, the Medicare preclusion authorities are managed by CMS. As described in Section III below, Medicare preclusion actions are typically revocation-based or conduct / behavior-based actions that effectively bar Medicare Part C and Part D plans from making payments to any individuals or entities that have been placed on the CMS preclusion list. Unlike the 43 Federal and State exclusion databases which are publicly accessible, the CMS preclusion database is only available Medicare Advantage (Part C) and Part D payor plans have with a valid Health Plan ID been granted access to the preclusion database by CMS.
III. How are Individuals and Entities Added to the CMS Preclusion List?
Individuals and entities added to the Preclusion List fall within two broad categories. These categories are examined in more detail below:
Category #1: Preclusion List – Revocation Based: Under this category, health care providers, suppliers, and prescribers can be placed on the Preclusion List if:
- The Medicare billing privileges of an individual or entity are currently revoked under 42 CFR §424.535; and
- There is an active reenrollment bar in effect under 42 CFR §424.535(c); and
- CMS has determined that the underlying conduct that led to the revocation is detrimental to the best interests of the Medicare program. In making this determination, CMS is to consider the following factors:
- The seriousness of the conduct underlying the individual’s or entity’s revocation.
- The degree to which the individual’s or entity’s conduct could affect the integrity of the Part D or MA program.
- Any other evidence that CMS deems relevant to its determination;
If these three revocation-related requirements have been met, CMS may place a health care provider, supplier, or prescriber on the agency’s Preclusion List.
Category #2: Preclusion List – Conduct / Behavior Based: Under this category, health care providers, suppliers, and prescribers can be placed on the Preclusion List if:
- The individual or entity has engaged in behavior for which CMS could have revoked the individual or entity to the extent applicable, if they had been enrolled in Medicare; and
- CMS determines that the underlying conduct that would have led to the revocation is detrimental to the best interests of the Medicare program. In making this determination under this paragraph, CMS considers the following factors:
- The seriousness of the conduct underlying the individual’s or entity’s revocation.
- Any other evidence that CMS deems relevant to its determination.
It is also important to keep in mind that CMS significantly expanded the bases for revoking a provider’s, supplier’s. or prescriber’s Medicare billing privileges under 42 CFR § 424.535(a) As discussed in a recent article examining the Final Rule entitled, “Medicare, Medicaid, and Children’s Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process,” the revised reasons for revocation that may be asserted by the government will be effective November 4, 2019.
As a final point in this regard, please note that OIG Exclusions and felony convictions will also result in an individual or entity being placed on the CMS Preclusion List.
IV. How Will an Individual or Entity Learn of Their Inclusion on the CMS Preclusion List?
When placing an individual or entity on the Preclusion List, CMS (through one of its Medicare Administrative Contractors (MAC)) is supposed to send written notice to the party. The MAC will send the letter to the address listed in the Provider Enrollment Chain and Ownership System (PECOS) system. The effective date of the preclusion action, along with reason(s) an individual or entity has been added to the list is required to be included in the letter. Additionally, the notice letter is supposed to provide information advising the individual or entity of their right to appeal their inclusion on the list.
V. How Long Can a Provider, Supplier, or Prescriber Stay on the CMS Preclusion List?
If a provider, supplier, or prescriber exhausts their first level of administrative appeal (either due to the fact that no appeal was filed in a timely fashion OR CMS denied the appellant’s request for reconsideration), CMS will add the individual or entity’s name to the Preclusion List. Please note, if the preclusion action has been taken due to the fact that the provider, supplier, or prescriber has been excluded from participation in Federal and State programs, the individual or entity will be placed on the CMS Preclusion List effective the date of the party’s exclusion. The length of time that an individual or entity will remain actively precluded will depend on the following:
- Length of Preclusion if Based on an Exclusion Action. If a provider, supplier, or prescriber is placed on the CMS Preclusion List due to the fact the individual or entity has been excluded from participation in Federal and State health care programs, the party will remain actively precluded for at least until the excluded party has been reinstated by the OIG.
- Length of Preclusion if Based on a Revocation Action. If a provider, supplier, or prescriber is placed on the CMS preclusion list due to the fact that the individual or entity is currently revoked (or would have been revoked had they enrolled in the Medicare program), the individual or entity will remain actively precluded for the length of their re-enrollment bar. The length of a re-enrollment bar ranges from 1 to 3 years, depending the seriousness of the reason for revocation.
- Length of Preclusion if Based on a Felony Conviction. If a provider, supplier, or prescriber is placed in the CMS preclusion list due to a felony conviction, the length of the preclusion will remain in effect for a 10-year period, beginning on the date of the felony conviction, unless CMS determines that a shorter time period is warranted (effective January 1, 2020).
Importantly, at the expiration of a preclusion action, a precluded party’s name is NOT totally removed from the CMS Preclusion List. As set out in April 2019 Final Rule, once a precluded party is reinstated, the party’s name will remain on the preclusion database list, but will be annotated to reflect the fact that the provider, supplier or prescriber has been reinstated. Once reinstated, the individual or entity may again submit claims for services and items to Medicare Advantage (Part C)) plans, and / or issue prescriptions for Part D drugs.
VI. Can an Individual or Entity Participating in the Medicare Program “Screen” to Ensure that Precluded Parties Aren’t Hired?
Unfortunately, Medicare providers and suppliers do not have access to the CMS Preclusion List. Only CMS approved Medicare Advantage (Part C) and Part D payor plans have with a valid Health Plan ID been granted access to the preclusion database. As CMS notes:
“CMS makes the Preclusion List available to the Medicare Advantage (MA) plans and Part D plans. MA [Medicare Advantage] plans will deny payment for a health care item or service furnished by an individual or entity on the Preclusion List. Part D plans will reject a pharmacy claim (or deny a beneficiary request for reimbursement) for a Part D drug that is prescribed by an individual on the Preclusion List.”
Under 42 CFR § 422.204(b), a Medicare Advantage organization is required to establish and comply with a comprehensive set of written credentialing and recredentialing requirements. The credentialing process is intended to serve as the initial set of program integrity safeguards used by Part C and Part D payor plans to prevent bad actors from enrolling in the programs. Unfortunately, this system is imperfect at best. More often than not, the credentialing of a newly-hired provider, supplier or prescriber is not requested by a participating health care organization prior to the organization’s employment of the newly-hired party. Notably, it is entirely possible that an individual may have been placed on the CMS Preclusion List due to his or her improper conduct or behavior (as described in Category #2 above), yet may not have been excluded from participation in Federal health care programs by the OIG. Therefore, even assuming that your organization properly screens its applicants against all available Federal and State exclusion lists prior to extending an offer of employment, it is still possible that you may unknowingly employ or enter a contract with a precluded individual or entity. We strongly recommend that your organization conduct proper due diligence before employing or contracting with a provider, supplier or prescriber. Should you inadvertently hire, or continue to employ, an individual who is precluded from providing services or items that will be billed to Medicare Advantage (Part C) plans, or issue prescriptions that will be billed to a Medicare Part D plan, those claims will be denied.
VII. How Do You Appeal a CMS Preclusion Action?
To establish the administrative framework to appeal a CMS preclusion action, CMS revised 42 CFR § 498.3(b), adding a new provision, Section (20), which made the decision to place an individual or entity on the Preclusion List an “Initial Determination” for appeal purposes. CMS further modified 42 CFR § 498.5, adding paragraph (n)(1). Under 42 CFR § 498.5(n)(1):
“Any individual or entity that is dissatisfied with an initial determination or revised initial determination that they are to be included on the preclusion list (as defined in § 422.2 or § 423.100 of this chapter) may request a reconsideration in accordance with § 498.22(a).” (emphasis added).
If an individual or entity files a Request for Reconsideration and is dissatisfied with the decision, the individual or entity can seek a hearing before an Administration Law Judge (ALJ). After an ALJ renders a hearing decision, either party (CMS or the individual / entity on the Preclusion List) may request Departmental Appeals Board review. Additionally, the individual or entity may also seek judicial review of the Department Appeals Board’s decision. For additional background information on the preclusion list, you may wish to review a recorded webinar presentation we made for the Texas Association for Home Care and Hospice.
Have you been placed on the CMS Preclusion List? Although the CMS Preclusion List has only been in place a short time, a number of Liles Parker attorneys have already handled (or, are in the process of handling) preclusion appeal cases. Our experienced health law attorneys can advise you on how to best respond to this challenge and represent you throughout the complex appeal process that has been established. For a free initial consultation regarding your situation, call us at: 1 (800) 475-1906.
 83 FR 16440 (April 16, 2018).
 Institutional providers and suppliers must still be enrolled in Medicare Fee-for-Services. Additionally, as part of their credentialing requirements, some Medicare Advantage plans may require that a provider or supplier be enrolled in the Medicare Fee-for-Service program.
 “Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021.” 84 FR 15680. (April 16, 2019).
 Part I of the article “Federal Exclusion Regulations and Enforcement Authorities, and How Provider’s Can Avoid Risk with Proper Exclusion Screening,” is in the process of being published in a series part series by the folks at Exclusion Screening.
 84 FR 15680.
 See article entitled “Medicare, Medicaid and CHIP Enrollment Revocation and Denial Authorities Have Expanded. What Steps are You Taking to Reduce Your Level of Risk? (September 18, 2019).
 An example of the letter sent to a revocation-based precluded party can be found at:
An example of the letter sent to a conduct / behavior-based precluded party can be found at:
 This would occur upon the expiration of the 60-day period in which a provider, supplier or prescriber has to file a reconsideration appeal to the proposed preclusion action. See 84 FR 15680, 15781.
 See CMS “Preclusion List Frequently Asked Questions.” Updated 08/07/2019.
 42 CFR § 498.5(n)(3).