Advisory Bulletin: Effect of Exclusion from Participation in Federal Health Care Programs

Date posted: May 9, 2013

The scope and use of the federal program exclusion authority continues to evolve. The DHHS OIG issued on May 8, 2013 the captioned 19 page bulletin.1 It addresses the scope and frequency of screening employees and contractors against the OIG’s List of Excluded Individuals and Entities (LEIE) to determine if they are excluded from participation in Federal Health Care Program. This is the first major update on the subject since their 1999 bulletin. The new bulletin restates the statutory background for exclusion authorities; describes the effect of exclusions; liabilities for employing or contracting with an excluded person; and how to determine whether a person is excluded. The following are key highlights of this bulletin.

The bulletin provides clarification of questions that have been raised over the years concerning the LEIE. The OIG advises that when checking the LEIE providers should maintain documentation of the names search performed in order to verify results of potential hits and to evidence that proper screening was performed. The search should be made of all names known of the individual (e.g. maiden name).

The OIG also addresses the question of the frequency by which sanction screening should take place. They note that there is no statutory or regulatory requirement on the frequency for checking the LEIE. The OIG notes that inasmuch as they update the LEIE monthly, screening each month “best minimize potential overpayment and CMP liability”. They further note that in January 2009, CMS issued a State Medicaid Director Letter (SMDL) recommending that States require providers to screen monthly; and in 2011 they issued final regulations mandating State to screen all enrolled providers monthly.3

The OIG also provided clarification regarding the determination of individuals and entities that should be screened. They stated any party providing an item or services that is directly or indirectly paid by a Federal health care program should be screened against the LEIE.

The OIG also responded to a number of questions concerning screening against other government exclusion and debarment lists. In particular, they addressed the differences between the LEIE and the GSA’s EPLS that was recently merged into the Systems for Awards Management or SAM.4 The OIG noted that the LEIE lists only exclusion actions taken by the OIG. They state that the LEIE should be considered the primary source. They noted that the OIG exclusion does not affect a person’s ability to participate in other Government procurement or non-procurement transactions. As to the debarments posted by the GSA, the OIG stated they have no authority to impose CMPs on the employment of a debarred person.

The OIG also addressed questions raised concerning the National Practitioner Data Bank and Healthcare Integrity and Protection Databank. Although providers may choose to check these databases, it is not a substitute for screening against the LEIE. The OIG calls for providers to use the LEIE as the primary database for purposes of exclusion screening.


1 http://oig.hhs.gov/exclusions/files/sab-05092013.pdf
2 SMDA #09-001
3 42 CFR, Section 455.436.
4 https://www.sam.gov

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