On September 30, 1999 the U.S. Department of Health and Human Services’ Department of Inspector General released a Special Advisory Bulletin on The Effect of Exclusion from Participation in Federal Health Care Programs. The brief document set off a deluge of questions and requests for clarification on critical policy guidelines in the fourteen years following its release. This year, after much anticipation, those in the healthcare industry frustratedly waiting for comprehensive answers to the very important questions created by that original bulletin will finally gain appeasement. Those answers come in the form of an updated twenty-page document released on May 8, 2013. Here we will briefly summarize the key points related in that document, and how they affect your policy initiatives.

Exclusion from Federal Healthcare Programs

The OIG has provided a clear explanation of the effect of OIG exclusions on health care entities. The latest bulletin reiterates that “. . .no Federal health care program payment may be made for any items or services furnished (1) by an excluded person or (2) at the medical direction or on the prescription of an excluded person.” This is a comprehensive, far-sweeping statement of scope covering employers and contractors at every organizational level. Additionally, the statement applies to any plans or services that provide direct or indirect benefits funded by Federal or State health care programs (e.g., Medicaid, Medicare, Tricare, and Veterans programs).

Examples of Excluded Individuals:

• Ambulance Drivers/Dispatchers who provide services billed to State/Federal programs
• Preparers of surgical trays or other medical equipment
• Reviewers of treatment, rehabilitation, or other medical plans
• Individuals occupying executive or other leadership positions with the organization (e.g., CEO, CFO, HR director, etc.)
• Those providing administrative support and management services (e.g., billing staffing, training, IT, etc.)
• Employees or contractors providing prescriptions or other medical services (e.g., pharmacists/pharmacy techs, lab/x-ray techs, etc.)
• Those volunteering in any capacity directly related to patient care

Liability and Penalties—Excluded Persons or Entities:

Excluded employees/contractors/volunteers/entities found to have sought payment from Federal programs may be subject to penalties up to and including:

• Civil Monetary Penalties (CMP) of $10,000 for each item or service furnished during the exclusion period
• Assessments of up to three times the amount claimed for each item or service rendered during the exclusion period
• Possible denial of future reinstatement requests for Federal health care programs
• Civil prosecution under the False Claims Act
• State or Federal criminal prosecution

Liability and Penalties—Employers and Contractees:

Provisions regarding employers explicitly state that a provider can be held liable if excluded persons or entities are allowed to participate, in any way, in the delivery of services payable by Federal programs. This applies irrespective of the payment status of the individual rendering those service (e.g., interns or those working on a volunteer basis). Providers employing or entering into contracts with individuals whom are known, or should be known, to be excluded are subject to the following penalties up to and including:

• Civil Monetary Penalties (CMP) of $10,000 for each item or service furnished during the exclusion period
• Assessments of up to three times the amount claimed for each item or service rendered during the exclusion period

Best Practices Moving Forward: LEIE

When setting up or revising sanction and exclusion screening policies, it is important that providers perform in-depth reviews of all positions within the organization. This practice will assure identification of those roles providing direct and indirect support to Federally payable programs. From there, It is recommended that providers run periodic checks of the OIG’s List of Excluded Individuals and Entities (LEIE) in addition to regular pre-employment screening. Through the proliferation of digital technologies, health care providers have more control than ever before in maintaining compliance with ever expanding Federal compliance regulations. An exhaustive monthly sanction and exclusion screening program administered by a licensed background screening expert is the surest way to safeguard against OIG penalties resulting from false claims.