Established in 1976, the OIG exclusion list was created to protect the sustainability of health care entitlement programs in order to serve program beneficiaries. The U.S. Department of Health & Human Services (HHS) began mandating exclusions in 1977 on behalf of the Medicare-Medicaid Anti-Fraud and Abuse Amendments, Public Law 95-142, now codified at section 1128 of the Social Security Act (Act), and the Office of Inspector General (OIG) implemented the exclusions program in 1981 with the added addition of the enactment of the Civil Monetary Penalties Law (CMPL) Public Law 97-35 (codified at section 1128A of the Act).
A large part of OIG exclusion list monitoring is to mitigate fraud, waste and abuse in Medicare, Medicaid and other government-funded health care programs. The enactment of the Health Insurance Portability and Accountability Act (HIPPA) in 1996 and the Balanced Budget Act (BBA) of 1997 served to expand the OIG’s authority to sanction and exclude.
Exclusion by the OIG from one program means exclusion from all HHS programs (pursuant to sections 1128 and 1156 of the Act). There are more than 100 HHS programs and 11 agencies that include Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and the Food and Drug Administration (FDA).
Those who file for Federal reimbursements for services or items provided by an excluded individual or entity are subject to entering into a Corporate Integrity Agreement, fines, civil monetary penalties up to $10,000 for each item or service provided during the time of exclusion, as well as damages in the amount of three times the claim for each item or service, and can have CMS billing privileges revoked permanently. Formal reinstatement is required following the term of exclusion.
The OIG’s exclusion list database, the List of Excluded Individuals and Entities (LEIE) is updated monthly and contains the current list of excluded individuals and entities. Health care organizations are required to check all new hires and contractors, as well as monitor regularly against the LEIE to assure there are no services or items provided by and/or reimbursed on behalf of an excluded individual or entity.
There are two types of OIG exclusions: Mandatory and Permissive. Mandatory is enforced by law and requires the OIG to exclude when an individual or entity is convicted for committing felony crimes—Medicare or Medicaid fraud, or other felony offenses related to state or federal health care programs; felony convictions related to controlled substances; or convictions for patient neglect or abuse. For permissive exclusions, the OIG has discretion on whether or not to exclude. The offenses prescribing permissive exclusions are on a misdemeanor level.
The non-compliant individual or entity receives a Notice of Intent to Exclude (NOI). At that point, the individual or entity can appeal to an HHS Administrative Law Judge (ALJ) and from there, an adverse decision can go on to be appealed to an HHS Departmental Appeals Board (DAB) and additionally, judicial review in Federal court is the last stage to appeal an exclusion.
The entity contracting with or employing an individual or entity going through this process is not notified of the NOI, but is responsible to act accordingly at the point where that entity or individual is listed on the LEIE. The existence of the LEIE satisfies the requirement that a hiring or contracting entity “knows or should know” of an individual or entity exclusion by initial and regular checking against the online searchable or downloadable list.
There are other screening and monitoring data points that give early warning signs to an impending exclusion, or serial exclusion evasion. For instance, hiring a provider who is not listed on the LEIE, but is engaged in the exclusion appeals process will likely appear on the Department of Justice’s database, or a State Attorney General’s list, or any number of primary sources that publish felony and misdemeanor criminal records. Individual licensing boards can also be checked for information about sanctions and disciplinary actions.
Protecting your organization and the patients it serves requires a proactive approach. Implementing a thorough screening and continuous monitoring program using aggregated data from multiple primary sources will help you steer clear of those on the brink of exclusion or from those who are excluded and intentionally evade detection.
CheckMedic® OIG exclusion monitoring is Verisy’s data technology platform tapping its proprietary data set of exclusions, sanctions, debarments, and disciplinary actions. Additionally, FACIS®, the most comprehensive data set for screening and monitoring health care providers, is continuously being updated. Verisys teams pull data from more than 5,000 data sources, adding roughly 75,000 records to the FACIS database each month. With one login, an organization can automate continuous monitoring and set alerts to receive notice of adverse action affecting one of your providers.
The OIG exclusion list is a vital source to check when screening and monitoring your provider population, but it does not provide enough information to have a complete picture of compliance. Using FACIS provides that complete picture. Taking the extra measure to check thousands of additional data sources protects your organization from financial and reputational risk and increases patient safety.
|Written by Susen Sawatzki
Healthcare Industry Expert
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