Kusserow on Compliance: Appealing exclusions–practical advice

Attorneys and consultants frequently have sanctioned clients desperately wanting to appeal and overturn the HHS Office of Inspector General (OIG) decision on exclusion, adding them to the List of Excluded Individuals and Entities (LEIE). The desperation is driven by the fact that exclusion is tantamount to putting them out of business. Few health care providers of services and products can function without access to federal health care programs and trying to continue servicing in that area after exclusion represents further violation of law with increased penalties.

Tom Herrmann, J.D., served over 20 years in the Office of Counsel to the Inspector General and as Appellate Judge for the Medicare Appeals Counsel and is frequently engaged to assist in Medicare appeals. He explained that there is, indeed, a process for appeal on exclusion to an HHS Administrative Law Judge (“ALJ”), the HHS Departmental Appeals Board (“DAB”), and ultimately the federal courts.  However, he warns that trying to appeal exclusions imposed by the OIG is not generally advisable, in that they are rarely overturned.  This is because most exclusion actions, both mandatory and discretionary, are derivative of a prior official action, whether it is court conviction or licensure board revocation.  Upon appeal, the underlying predicate action for exclusion may not be challenged through the established administrative and judicial review process.  The governing regulations provide further that an ALJ may not “review the exercise of discretion by the OIG to exclude an individual or entity under section 1128(b) of the Act, or determine the scope or effect of the exclusion.”   Moreover, the ALJ is prohibited from setting “a period of exclusion at zero, or reduce[ing] a period of exclusion to zero, in any case where the ALJ finds that an individual or entity committed an act described in section 1128(b) of the Act.”

Furthermore, an excluded party can affect entities with who affiliated. Should a provider permit an excluded party to be involved in services, it will create a liability to that organization.  As a condition of participation in Medicare/Medicaid, it is the affirmative duty and responsibility of the organization to ensure that any provider of services or products that is included in claims submitted for payment to those programs are licensed, qualified and NOT excluded.  To engage excluded parties places in jeopardy the entity’s status as a provider.  Furthermore, it is the OIG’s position that all claims submitted that include anything from a sanctioned provided may be considered false and potentially fraudulent.  Providers should take steps to avoid being poisoned by excluded parties.  Sanction screening can be a challenge because of multiple exclusion databases and variations of names and data.

Practical tips

Organizations should consider the following:

  • The fact that most exclusions arise from court or licensing agency actions underscores the importance of sanction screening and conducting background investigations prior to engaging employees, contractors, and vendors, to ensure they have not been subject to adverse actions by these authorities.
  • Screen parties before engaging them and thereafter periodically (e.g. monthly) against the LEIE or relevant State sanction lists.
  • Ensure data used in screening is accurate and up to date. Frequently, sanctioned parties disguise their exclusion with a name change (e.g. spouse surname), variations on name (particularly significant in the case of names that are transliterated).
  • Include on any application for employment or for medical privilege a statement that they are not under investigation and have not been subject of adverse action by any duly authorized enforcement agency.
  • Check the enrollment and exclusion status of physicians and other non-physician practitioners that routinely order or prescribe, as any services ordered or prescribed by an excluded health care practitioner will not be eligible for program payments.
  • If a party is verified to be on an exclusion list, take immediate action to terminate the party; determine the monetary exposure of the services involving that party that was billed to Federal health care programs; and disclose the findings to the OIG.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2017 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: OIG continues distancing itself from the GSA debarment list

The HHS Office of Inspector General (OIG) has never called for all health care organizations to screen against the General Services Administration (GSA) System for Award Management (SAM). In the past, the OIG has noted in its various compliance guidance documents that the GSA maintains a federal debarment list and cited it as an additional resource available to health care organizations. The fact that SAM was mentioned by the OIG often leads organizations to believe that they must screen against both the OIG’s List of Excluded Individuals and Entities (LEIE) and SAM.

Yet, for the last several years, the OIG has distanced themselves from the recommendation to health care organizations to screen SAM. In the OIG’s 2013 “Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs” the agency addressed questions regarding its position on screening against SAM and contrasted the LEIE and SAM. The OIG made it clear that it would take action only on parties found on the LEIE and that they had no interest or authority to address confirmed hits on the GSA SAM. It also noted that in January 2011, CMS issued final guidance mandating states to screen all enrolled providers monthly against both the LEIE and SAM, but that was CMS’ position, not the OIG’s position.

This means CMS is the only federal government agency calling for health care providers and plans to screen SAM. The CMS Medicare Enrollment Application for Institutional Providers requires applicant hospitals to have a compliance plan that states that the hospital checks all managing employees against the exclusion/debarment lists of both the OIG LEIE and the GSA SAM. For health plans, the regulation states that they cannot contract with any individuals or entities that are debarred by GSA as a condition to maintaining active enrollment status. CMS also requires managed care plans to screen prior to the hiring or contracting of any new employee, temporary employee, volunteer, consultant, governing body member, or First Tier, Downstream or Related Entity (FDR), and on a monthly basis thereafter. It is worthwhile to remember that CMS has not established any enforcement mechanism to deal with providers who have relationships with parties on the SAM debarment list.

As such, distance is growing between OIG and CMS regarding screening against SAM, which has never been user-friendly for health care organizations and yields numerous false matches that then take time and effort in resolve and verify. SAM records simply have very limited identifying information on individuals and entities. GSA designed their system to be used by federal government agencies for procurement purposes, and not for any other purpose or for use by non-federal organizations.

The latest policy statement by the OIG was announced at the recent Health Care Compliance Association (HCCA) Compliance Institute. An OIG Deputy Branch Chief noted that the OIG will soon no longer include screening the SAM as part of compliance integrity agreement (CIA) requirements. The OIG must recognize the added burden on organizations to resolve false hits to SAM. However, the agency made it clear that screening against the LEIE is mandatory, whether or not an entity is under a CIA. So, providers and plans are still confronted with CMS’ position on the subject and continue to struggle with all the problems presented by the user unfriendly SAM system.

Jillian Bower, a compliance screening expert stated that “any provider with a large work force, or that engages many contractors or vendors, finds manual screening too costly, especially when multiple federal and state exclusion lists must be included. Most organizations turn to using a vendor that offers a sanction screening application that can greatly facilitate the process by enabling providers to conduct batch screenings of a large number of names simultaneously against multiple federal and state exclusion lists. However, there remains the problem of resolving potential matches and for many the answer is to simply outsource the entire process to a vendor who will conduct sanction screening against all identified exclusion lists, as well as resolving potential matches.”

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2016 Strategic Management Services, LLC. Published with permission.