Exclusion Screening
Healthcare Compliance:
Exclusion Screening Explained

1. What is healthcare compliance?

Healthcare compliance is the ongoing process of meeting the legal, ethical, and professional standards applicable to a particular healthcare organization or provider. To be compliant, healthcare organizations and providers need to develop effective processes, policies, and procedures to define appropriate conduct, train the organization’s staff, and monitor the adherence to defined policies. Healthcare compliance covers numerous areas including patient care, billing, reimbursement, HIPAA privacy and security, and many more.

The governing body and the executive officers of the healthcare organization bear the ultimate responsibility for its compliance or lack of it. The organization’s governing body is responsible for directing the organization’s administrators to develop and implement the healthcare compliance program together with authorizing funds to accomplish the task.

While the governing body, the compliance officer, and the compliance committees have primary responsibility for the organization’s compliance program, every employee is responsible in their own way for healthcare compliance, and the success of the program. Accordingly, individual members of the organization need to report any healthcare compliance concerns they have up the chain of command and report anything that appears to be out of the ordinary, unusual, or questionable.

A healthcare compliance program is imperative for every healthcare organization and provider. Since it is an ongoing process, every organization needs to constantly review and examine its policies and procedures to ensure adherence to requirements established by laws, regulations, and professional standards as well as to regularly audit its performance.

2. What is the OIG?

The Office of Inspector General (OIG) for the United States Department of Health and Human Services (HHS) is charged with identifying and combating waste, fraud, and abuse in more than 300 of HHS programs, including Medicare and programs conducted by agencies within HHS, such as the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health.

OIG Mission

The mission of the OIG, as mandated by the Inspector General Act, is to protect the integrity of HHS programs as well as the well-being of the beneficiaries of those programs.

OIG holds accountable those who bill HHS programs but do not meet Federal health program requirements or who violate Federal laws regarding the use of Federal healthcare funds. OIG also identifies opportunities to improve the economy, efficiency, and effectiveness of HHS programs.

OIG reports both to the Secretary of HHS and to the United States Congress about program and management problems and recommendations to correct them. OIG’s work is carried out by regional offices nationwide that perform audits, investigations, inspections, and other mission-related functions.

HHS OIG is the largest inspector general’s office in the Federal Government, with more than 1,700 employees dedicated to combating fraud, waste and abuse, and to improving the efficiency of HHS programs. Most of OIG’s resources go to overseeing Medicare and Medicaid – programs that represent much of the Federal budget and affect the most vulnerable U.S. citizens. OIG’s oversight extends to programs under other HHS institutions, including the Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration.

The current Inspector General for HHS is Christi Grimm.

OIG Components

The OIG consists of the following six components:

The Office of Investigations (OI) conducts criminal, civil, and administrative investigations of allegations of wrongdoing regarding HHS programs or HHS beneficiaries. Investigative efforts lead to criminal convictions, civil judgments and settlements, administrative sanctions, and/or civil monetary penalties. Additionally, a small Protective Operations Branch (POB) within OI consists of special agents dedicated solely to the protection of the Secretary of HHS in support of domestic and overseas missions.

The Office of Audit Services (OAS) provides all auditing services for HHS, either through its own resources or by overseeing the audit work of others. Audits examine the performance of HHS programs and/or its grantees and contractors in carrying out their respective responsibilities and provide independent assessments of HHS programs and operations.

The Office of Evaluation and Inspections (OEI) conducts management and program evaluations that focus on issues of concern to HHS, Congress, and the public. OEI generally focuses on identifying instances in which the management of large HHS programs can be improved to increase the well-being of beneficiaries or to save Federal healthcare dollars.

The Office of Counsel to the Inspector General (OCIG) represents OIG in all civil and administrative fraud cases and, in connection with these cases, negotiates and monitors corporate integrity agreements, a healthcare compliance agreement in which healthcare providers or other entities consent to a set of obligations in order to avoid being excluded from participating in any Federal healthcare program. OCIG also provides guidance to the healthcare industry to promote compliance with Federal laws and regulations and provides legal support to OIG operations.

The Immediate Office, which includes the Office of External Affairs which handles OIG’s interactions with Congress and the public, is directed by the Inspector General with the assistance of the Principal Deputy Inspector General and his staff.

The Office of Management and Policy provides mission-support services to the Immediate Office of the Inspector General and other OIG components.

OIG Enforcement Actions

Criminal and Civil Enforcement

Criminal and civil enforcement actions often result from OIG’s work as part of its Most Wanted Healthcare Fugitives initiative, the Medicare Fraud Strike Force, the Healthcare Fraud Prevention and Enforcement Action Team, and other similar efforts.

State Enforcement Actions

Medicare Fraud Control Units (MFCU) investigate and prosecute Medicaid fraud as well as patient abuse and neglect in healthcare facilities. At the moment, MFCUs operate in 49 States and in the District of Columbia. OIG certifies, and annually recertifies, each MFCU. OIG also collects information about MFCU operations and assesses whether they comply with statutes, regulations, and OIG policy.

Civil Monetary Penalties and Affirmative Exclusions

The Office of Inspector General (OIG) has the authority to seek civil monetary penalties (CMPs), assessments, and exclusion against an individual or entity based on a wide variety of prohibited conduct.

Corporate Integrity Agreement Enforcement

The OIG has the right to impose stipulated penalties for non-compliance with the requirements of a Corporate Integrity Agreement (CIA). A material breach of the terms of the CIA may also result in the provider’s exclusion from participation in the Federal healthcare programs.

Corporate Integrity Agreement is arranged with a healthcare entity or provider and it is part of a settlement of federal healthcare program investigations resulting from false claims statutes. Corporate Integrity Agreements create a framework within which the company needs to operate in order to avoid being excluded from participation in federal healthcare programs. They do not include disciplinary actions. Instead, they set minimum standards for which a healthcare provider or entity should be held accountable and drive compliant behavior. An updated list of Corporate Integrity Agreements can be found on the OIG Website.

Since CIAs are used as tools that promote model standards for ensuring compliance with healthcare laws, healthcare organizations should keep their requirements in place even after a typical five-year term of the CIA. The failure to comply with the terms of the OIG Corporate Integrity Agreement may lead to additional penalties, an extension of the terms of a CIA, or exclusion.

OIG Work Plan

The OIG Work Plan includes different ongoing projects or projects that are planned in the near future as part of the OIG mission. Projects listed in the Work Plan include the Centers for Medicare & Medicaid Services (CMS), public health agencies such as the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH), and human resources agencies such as the Administration for Children and Families (ACF) and the Administration on Community Living (ACL). The OIG also plans work related to issues that refer to departmental programs, including State and local governments’ use of Federal funds, as well as the functional areas of the Office of the Secretary of Health & Human Services (HHS). Apart from this, some Work Plan items reflect work that is statutorily required.

Since June 2107, the OIG made a change in how its Work Plan is administered. Previously, it was published once a year and contained the specific activities the OIG would undertake in the following 12 months. Now, the OIG continuously updates the Work Plan and adds new auditing activities to meet priorities and to anticipate and respond to emerging issues. The list of Active Work Plan Items is searchable by a month of listing, by agency, by title, and by Report number. Healthcare providers can also easily identify projects that have recently been issued, and recent final reports.

OIG Background

Since the early 1970’s, the Department of Health and Human Services (HHS), Office of the Inspector General (OIG) has the authority and responsibility  “to protect the integrity of Department of Health & Human Services (HHS) programs as well as the health and welfare of program beneficiaries”. The OIG is acting in the people’s best interest to regulate and enforce violations of healthcare fraud, waste, and abuse.

3. OIG Exclusions

Exclusion screening is the process of verifying that a current or potential employee is not classified as an excluded individual who is prohibited from participation in any Federal healthcare program. The OIG imposes exclusions under the authority of sections 1128 and 1156 of the Social Security Act. A list of all OIG exclusions and their statutory authorities can be found on the Exclusion Authorities page.

OIG’s exclusion process is governed by regulations that implement sections of the Act. When an individual or entity gets a Notice of Intent to Exclude (NOI), it does not necessarily mean that they will be excluded. OIG will carefully consider all material provided by the person who received the NOI before making a decision. All exclusions implemented by OIG may be appealed to an HHS Administrative Law Judge (ALJ), and any adverse decision may be appealed to the HHS Departmental Appeals Board (DAB). Judicial review in Federal court is also available after a final decision by the DAB.

The OIG does not issue individual warnings or notifications regarding excluded individuals. Employers are required to search the Federal exclusion database and SAM.gov, as well as each individual state’s Medicaid Exclusion database, to verify the status of each employee.

Although the OIG maintains its own database of excluded individuals, individual states may exclude individuals for reasons other than the ones cited by Federal law, without immediately reporting to the OIG or other states. Therefore, the only way for employers to ensure healthcare compliance with the mandated requirement is to conduct a nationwide search each month.

Types of Exclusions

The OIG is required by law to exclude from participation in all federal healthcare programs individuals and entities on a number of grounds.

The OIG is required by law to impose mandatory exclusions for the reasons outlined in the Social Security Act. Permissive exclusions, on the other hand, can be imposed by the OIG at their discretion for a much greater number of reasons, some of which can be non-healthcare related.

OIG’s Administrative Process for Imposing Exclusions

Exclusions under Section 1128

When OIG is considering the exclusion of an individual or entity under section 1128 of the Act, the administrative process is governed by regulations codified at 42 CFR sections 1001.2001 through 1001.2007. However, depending on the basis for the proposed exclusion, the process can vary.

For all proposed mandatory exclusions that are longer than the mandatory minimum five-year period, and most proposed permissive exclusions, the administrative process is the same. OIG sends out a written NOI to any individual that they are considering excluding. The NOI includes the basis for the proposed exclusion and a statement about the potential effect of exclusion.

The NOI is pre-decisional and allows the individual or entity 30 days to respond in writing with any information or evidence relevant to whether the exclusion is warranted and to raise any other related issues, such as mitigating circumstances. OIG considers all available information in making a final decision about whether to impose the exclusion.

If OIG decides to proceed with an exclusion, they send the individual or entity a Notice of Exclusion along with information about the effect of the exclusion and appeal rights. For mandatory exclusions that are for the minimum five-year period, OIG may not send an NOI. For these exclusions, a Notice of Exclusion is the first notification sent. Exclusions are effective 20 days after the Notice of Exclusion is mailed, and notice to the public is provided on OIG’s website. The exclusion may be appealed to an ALJ, and any adverse decision may be appealed to the DAB. Judicial review is also available after a final decision by the DAB.

Exclusions under Section 1128(b) (6)

When a permissive exclusion is being considered under section 1128(b) (6) of the Act, the NOI allows the individual or entity to request an opportunity to present an oral argument to an OIG official before a decision about whether to execute is reached. This is in addition to the right to submit documentary evidence and written argument.

If OIG decides to proceed with an exclusion, we send the individual or entity a Notice of Execution along with information about the effect of the exclusion and appeal rights. When a permissive exclusion is imposed under sections 1128(b) (12) or (b) (13) of the Act, OIG is not required to send an NOI. The individual or entity is sent a Notice of Exclusion along with information about the effect of the exclusion and appeal rights. An exclusion under section 1128(b) (12) is effective immediately and exclusion under section 1128(b) (13) is effective 20 days after the Notice of Exclusion is mailed, and notice to the public is provided on OIG’s website.

Exclusions under Section 1128(b) (7)

When OIG is considering excluding an individual or entity under section 1128(b) (7) of the Act, the administrative process differs. OIG sends the individual or entity a written Notice of Proposal to Exclude. The written notice includes the basis for the proposed exclusion, the length of exclusion, the factors considered in setting the exclusion period, the effect of the exclusion, the earliest date on which OIG will consider a request for reinstatement, appeal rights, and reinstatement information. The individual or entity may file a written request for a hearing within 60 days of receipt of the Notice of Proposal to Exclude. If the individual or entity does not request a hearing, the exclusion goes into effect 60 days after the receipt of the Notice of Proposal to Exclude. If the individual or entity makes a timely written request for a hearing, and OIG has determined that the health and safety of individuals receiving services under Medicare or any State health program do not warrant immediate exclusion, and exclusion will only go into effect as of the date of the ALJ’s decision, if the ALJ upholds OIG’s decision to exclude. Any adverse decision may be appealed to the DAB, and judicial review is available after a final decision by the DAB.

Exclusions under Section 1156

If OIG excludes an individual under section 1156 of the Act, OIG sends a written notice notifying the individual of the exclusion. The written notice includes the legal and factual basis for the exclusion, the length and effective date of the exclusion, the effect of the exclusion, appeal rights, reinstatement information, and patient notification option. The exclusion goes into effect 20 days after the date of the written notice. The individual may file a written request for a hearing before an ALJ within 60 days of receipt of the written notice. Any adverse decision by the ALJ may be appealed to the DAB, and judicial review is available after a final decision by the DAB.

An individual excluded under section 1156 of the Act may request a preliminary hearing if the location where services are rendered to over 50 percent of the individual’s patients at the time of the written notice is in a rural health professional shortage area or in a county with a population of less than 70,000. Such an individual may file a written request for a preliminary hearing before an ALJ within 15 days of receipt of the written notice. A request for a preliminary hearing stays the effective date of the exclusion pending the ALJ’s decision at the preliminary hearing.

What Are the Effects of Exclusion?

The principal effect of exclusion is that payment is prohibited for anything that an excluded individual furnishes, orders, or prescribes, and any administrative and management services furnished by the excluded individual. This prohibition extends to anyone who employs or contracts with the excluded individual.

The OIG provides an in-depth review of the effects of exclusion in its Updated Special Advisory Bulletin on the Effect of Exclusions from Participation in Federal Health Programs. The Bulletin sets forth the following specific instances where payment of items and services are prohibited with Federal healthcare program funds:

• In general, payment of any items and services furnished by an excluded individual or entity is not reimbursable under Federal healthcare programs;
• Payment of any items and services furnished at the medical direction or prescription of an excluded physician are not reimbursable when the individual or entity furnishing the services either knows or should know of the exclusion;
• Payment for administrative and management services provided by an excluded individual that is not directly related to patient care, but is a necessary component of providing items and services to Federal program beneficiaries;
  • Payment for administrative services, including the processing of claims for payment, performed for a Medicare intermediary or carrier, or a Medicaid fiscal agent, by an excluded individual;
  • Other types of administrative and management services, such as health information technology services and support, strategic planning, billing and accounting, staff training, and human resources, unless wholly unrelated to Federal healthcare programs.
• Payment for services performed by excluded nurses, technicians, or other excluded individuals who work for a hospital, nursing home, home health agency, or physician practice, where such services are related to administrative duties, preparation of surgical trays, or review of treatment plans, even if the individuals do not furnish direct care to Federal program beneficiaries;
• Payment for services performed by excluded ambulance drivers, dispatchers, and other employees involved in providing transportation reimbursed by a Federal health care program, to hospital patients or nursing home residents;
• Payment for services performed for program beneficiaries by excluded individuals who sell, deliver, or refill orders for medical devices or equipment being reimbursed by a Federal healthcare program.

In addition to the scenarios listed above, the Bulletin provides additional clarification on the effect of an OIG exclusion. The Bulletin states that the payment prohibition applies to all methods of Federal healthcare program payment, whether from itemized claims, cost reports, fee schedules, a prospective payment system or bundled payment, or other payment system and applies even if the payment is made to a State agency or a person that is not excluded.

Are There Exceptions?

There are limited exceptions. The OIG Special Advisory Bulletins explains and clarifies the situations where a healthcare provider who receives funds from a Federal healthcare program may employ an excluded individual. In short, an entity that receives federal healthcare funding may employ an excluded individual where the provider is both able to pay the individual exclusively with private funds or from other non-Federal funding sources and where the services furnished by the excluded individual relate solely to non-Federal program patients.

The Bulletin also provides the following guidance regarding the circumstances under which an excluded person may be employed by, or contract with, a provider that receives payments from Federal healthcare programs:

• Federal healthcare programs do not pay, directly or indirectly, for the items or services being provided by the excluded individual;
• A provider need not maintain a separate account from which to pay the excluded person, as long as no claims are submitted to or payment is received from Federal healthcare programs for items or services that the excluded person provides and such items or services relate solely to non-Federal healthcare program patients;
• The healthcare provider may reduce or eliminate its civil monetary penalties (CMP) liability if it is able to demonstrate that it reasonably relied on the staffing agency to perform a check of the List of Excluded Individuals and Entities (LEIE) for the nurses furnished by the staffing agency (e.g., the staffing agency agreed by contract to perform the screening of the LEIE and the provider exercised due diligence in ensuring that the staffing agency was meeting its contractual obligation).

The Bulletins require that the excluded individual and Federal funds never overlap. In an effort to keep healthcare providers from CMP liability, the Bulletins set forth a number of situations where employment of an excluded individual could lead to CMP liability.

4. Exclusion Databases

One of the most important things to understand about exclusion screening are the differences between the exclusion databases and where they are located. At the federal level, exclusions can be found on the Office of Inspector General’s List of Excluded Individuals and Entities (LEIE) as well as the GSA SAM.gov exclusion database, which contains exclusion records for many industries. In addition to this, the majority of states also have their own Medicaid exclusion lists. All of these exclusion lists need to be individually cross-checked and monitored on a monthly basis in order to remain compliant. What makes this process even more difficult is that not all of them share the same data with the OIG nor with each other.

LEIE

The List of Excluded Individuals and Entities (LEIE) is a list of all individuals and entities currently excluded by the OIG. The LEIE is available to the public and can be easily searched using the name of employees or entities. Once individuals or entities are reinstated, they are immediately removed from the LEIE. LEIE searches can be performed using the OIG’s Online Searchable Database or by downloading the LEIE Downloadable Database.

Searching the LEIE is important because healthcare providers who hire an individual on the LEIE may be subject to civil monetary penalties (CMP). Under the CMP authority, providers may face CMP exposure if they submit claims to a federal healthcare program for items or services provided, directly or indirectly, by excluded individuals. CMP liability applies to all of the following: direct patient care, indirect patient care, administrative and management services, and items or services furnished at the medical direction or on the prescription of an excluded person when the person furnishing the services either knows or should know of the exclusion. In order to avoid CMP liability, healthcare entities must routinely check the LEIE to ensure that potential and current employees are not excluded.

The LEIE is available in two formats:

• The Online Searchable Database enables users to enter the name of an individual or entity and determine whether they are currently excluded. If a match is made on an individual, the database can verify with an individual’s Social Security Number (SSN) that the match is unique. Employer Identification Numbers (EINs) are available for verification of excluded entities.
• The Downloadable Database enables users to download the entire LEIE to a personal computer. Supplemental exclusion and reinstatement files are posted monthly on the OIG’s website, and these files can be merged with the previously downloaded data file to update the list. Users who do not wish to rely on the supplements to keep the information updated can download the Downloadable Data File each month.

Profile updates (changes to information on specific excluded individuals and entities) are also available on the Downloadable Database file web page.

The Downloadable Database does not contain SSNs or EINs. Therefore, verification of specific individuals or entities through the use of the SSN or EIN must be done via the Online Searchable Database.

GSA SAM

The GSA or General Services Administration is the federal entity that excludes companies and individuals from receiving federal contracts. In addition to being excluded at the OIG LEIE, an individual or entity can also be debarred or sanctioned at the GSA SAM which includes the Excluded Parties List System (EPLS). GSA administers EPLS and SAM, both of which contain debarment actions taken by various federal agencies, including exclusion actions taken by the OIG.

SAM.gov

The SAM system includes individuals and entities found on the OIG exclusion list, and it is necessary for healthcare organizations to continually check this database. SAM’s purpose is to prevent companies from doing business with an individual or entity that has been debarred, sanctioned, or excluded by a federal agency. The SAM data is populated by other federal agencies and it is designed to provide one single search for such actions. However, SAM does not have any direct authority to fine a company if it does business with an individual or entity that is on their list.

To verify if an individual or entity is listed as excluded on the SAM database, it is necessary to enter the following information:

• The address of the individual or entity.
• The full name of the individual or company.
• The Data Universal Numbering System (DUNS) number or Commercial and Government Entity (CAGE) code of the entity.

Individuals are not assigned DUNS numbers. To check for an exclusion for an individual, it is necessary to type in the name.

5. Are Exclusions Permanent?

While getting on the OIG’s list of excluded individuals can pose some serious problems for personal credibility and financial stability, it is not an irreversible situation.

At the end of the OIG exclusion term, the affected provider needs to apply for reinstatement to receive an authorized notice from the OIG stating the request was granted. Excluded providers may only begin the process of reinstatement 90 days before the end of the excluded period. Premature requests for reinstatement will not be considered, so it is important to be careful when to apply.

OIG Reinstatement Steps

1. To apply for reinstatement, a written request has to be sent to the OIG.
2. Upon receiving a written request, the OIG provides Statement and Authorization forms that need to be completed, notarized, and returned.
3. The OIG evaluates the information on these forms and sends a written notification of the final decision on reinstatement directly to an individual or entity.

The reinstatement process typically requires up to 120 days to complete but can take longer. If the OIG grants the written request for reinstatement followed by a notice in writing, individuals or entities are taken off the list. However, it is advisable to double-check if this is the case.

If the OIG denies a written request for reinstatement, individuals or entities may apply again and redo the whole process after one year.

While the process of reinstatement can be long and complicated, following the established procedures in order and at the right point in time can effectively result in getting off of the OIG exclusion list. It is important to follow directions, fill out the forms in their entirety, and not apply before 90 days prior to the end of the excluded term.

What Effect Does an OIG Exclusion Reinstatement Have on a Separate State Medicaid Exclusion?

If a provider or entity is excluded by both a State Medicaid exclusion authority and the OIG LEIE, then they need to apply for reinstatement at both separately. The State Medicaid exclusion authorities do not remove an individual from the State list just because they have been removed from the OIG LEIE. Even if the reason the OIG added the individual to the LEIE was due to the State Medicaid exclusion, the reinstatement by the OIG has no effect on the separate State Medicaid exclusion and vice versa.

Regaining Healthcare Benefits

After being removed from the OIG list of excluded individuals, individuals or entities need to reapply for the federal healthcare services they need. The federal government does not have a system that automatically notifies healthcare providers of the removal from the OIG exclusion list. Furthermore, it is important to check the state’s databases to ensure that removal from the exclusion list is complete.

Healthcare licensing boards may approve individuals or entities for services by issuing them a provider number, but their services cannot be used until reinstatement is official. If individuals or entities submit forms incorrectly or provide inaccurate documentation to the OIG office, their reinstatement may be canceled. This cancellation is not permanent, but they would have to wait one year before restarting the reinstatement process.

An excluded provider or entity can apply at a certain point for reinstatement to be removed from the OIG LEIE list. However, it is not automatic and can be denied if it is prematurely requested. If a provider’s exclusion term has expired, there is a defined protocol to apply for reinstatement at the OIG site. Also, if the provider is excluded separately at a State exclusion authority, they must separately apply for reinstatement there. The OIG reinstatement is not the same as reinstatement by or at a State Medicaid exclusion authority.

6. Penalties for OIG Non-Compliance

Providers that employ or contract with individuals or entities that such provider knows or should know are excluded from participation in federal healthcare programs may be subject to different penalties.

The OIG assesses civil fines and monetary penalties.

The penalties for allowing services to be performed by an excluded individual or entity can include:

• $10,000 per each item claimed or services provided;
• Treble damage (3 times the amounts claimed to CMS for reimbursement);
• Possible program exclusion of the healthcare organization;
• Possible loss of the right to bill CMS for services rendered;
• Possible additional fines for filing false claims under the False Claims Act (Penalties up to $11,000 per claim, and possible placement in a Corporate Integrity Agreement with the OIG);
• Possible criminal fines and/or jail time.

7. How to Conduct Exclusion Screening

In the Updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Healthcare Programs, the OIG provided specific guidance to the healthcare industry on the frequency of screening employees and contractors to determine whether they are excluded persons. While noting that there is no statutory or regulatory requirement to check the OIG LEIE and that providers may decide how frequently to check it, the OIG confirmed that it updates the LEIE monthly, so screening employees and contractors each month best minimizes potential overpayment and CMP liability.

The OIG does not issue individual warnings or notifications regarding excluded individuals. Employers are required to search the Federal exclusions database and SAM.gov, as well as each individual state’s Exclusion Database, to verify the status of each one of their employees. In addition to this, various states require additional searches as well.

The employer inputs the employee’s (or potential hire’s) name and date of birth into the database. The database returns a list of potential matches, including individuals with similar names. The employer must then independently verify whether or not the employee in question is the same person as the excluded individual. Employers are also required to check all versions of each employee’s name, including maiden names, combined names, and name diminutives.

Although the OIG maintains its own database of excluded individuals, individual states may exclude individuals for reasons other than the ones cited by Federal law, without immediately reporting to the OIG or to the other states. The only way for employers to ensure compliance with the mandated requirement is to conduct a nationwide search every month.

8. Exclusion Screening Tips

Given the penalties, potential repayments, and recent government warnings, providers should do the following to protect against liability for doing business with an excluded individual or entity:

1. Check the LEIE and other exclusion databases before hiring employees. LEIE checks have to be part of the human resources, credentialing, and contracting processes.
2. Conduct screening on a regular basis thereafter. If possible, it should be done monthly. Providers may download the LEIE and run an electronic search against employees, contractors, vendors, and medical staff.
3. If monthly checks are impossible, providers need to check exclusion databases as frequently as possible. The more often they check it, the safer they will be and the lower the potential penalties.
4. When checking the LEIE, it is important to beware of name changes. If possible, it is advisable to cross-check the LEIE with birthdates, social security numbers, employee identification numbers, or other available data using the OIG’s online searchable database. Employment and credentialing applications should require disclosure of other names by which the applicant has been known so that they can be included in LEIE searches.
5. Include questions in applications and terms in contracts that require the applicant, provider, employee, or contractor to confirm that they are not excluded. Also, ensure that relevant agreements, contracts, and policies condition any arrangement on the party’s eligibility to participate in federal programs.
6. Require any applicant, provider, employee, or contractor for immediate notification if they are excluded from federal programs. Contracts and other agreements should allow providers to immediately terminate the relationship in the event of program exclusion.
7. In case there is an excluded provider, it is advisable to carefully consider options. Under the ACA, entities generally have an obligation to report and repay overpayments within 60 days. Providers may want to consider using the OIG Self-Disclosure Protocol. The timing, method, and manner of self-disclosure may impact the penalties and repayment obligation that may be imposed.
8. Outsource the entire process to an outside vendor and get an automated solution to meet Federal and state exclusion screening obligations. Manually screening for OIG and other exclusions every month is a labor-intensive job, especially for a large company. With the right technology, the exclusion screening process can be conducted more promptly and regularly, thus reducing the risk of incurring significant monetary losses.

9. OIG Healthcare Compliance Program

In order to guide healthcare organizations in the process of achieving effective compliance, the OIG released a resource document to help healthcare organizations measure the effectiveness of their compliance programs.

The guide, titled Measuring Compliance Program Effectiveness: A Resource Guide and published March 27, 2017, is the product of a roundtable discussion involving OIG staff and healthcare compliance professionals. Their goal was to provide metrics for measuring compliance program effectiveness that would be helpful to a wide range of healthcare organizations differing in size, operational complexity, industry sectors, and resources.

While the Resource Guide lists over 400 individual healthcare compliance program metrics, its authors emphasize that it is not meant to be a checklist or applied in its entirety. Rather, healthcare organizations should treat the Resource Guide as an idea bank from which they can select those metrics most suited to their needs, resources, and risks.

The Resource Guide is divided into seven sections and each one contains suggestions for what to measure to evaluate the effectiveness of an organization’s healthcare compliance program and how to measure those standards.

Standards, policies, and procedures

The Guide highlights the importance of having the relevant policies and procedures in place to form the structure of an organization’s healthcare compliance program. The metrics focus on basic compliance functions, including measuring employees’ access to the policies, implementing internal processes for periodically reviewing the policies, assessing the quality and applicability of the policies, maintaining an organizational code of conduct, and ensuring an organization-wide understanding of healthcare compliance policies and procedures.

Compliance program administration

A key component of an effective healthcare compliance program is a well-functioning administration that involves everyone in compliance processes. The metrics highlighted in this section offer ideas to judge the effectiveness of an organization’s board of directors, compliance committees, compliance officers, compliance staff, and general culture of compliance.

Screening and evaluation of employees, physicians, vendors, and other agents

This section includes ideas for measuring how well organizations evaluate employees, vendors, and affiliated individuals for possible exclusion and conflicts of interest, and whether the organization has a plan for responding to these issues. The metrics remind organizations that an effective healthcare compliance program concerns not only the organization’s own employees, but also the organization’s third-party vendors, agents, and affiliated individuals.

Communication, education, and training on compliance issues

The Guide provides organizations with tools to measure whether individuals receive effective job-appropriate training, whether the organization’s governing body is adequately trained in compliance efforts, and whether that training is updated with necessary regulatory changes or compliance failures. There are also ideas on how to measure whether an organization has established a culture of healthcare compliance.

Monitoring, auditing, and internal reporting systems

This section contains metrics that an organization may use to evaluate whether its processes for monitoring violations of laws and regulations, its internal reporting system for noncompliance, and its routine risk assessments and compliance audits are effective. It also highlights the importance of an organization’s response to compliance audits or instances of noncompliance, including corrective action plans.

Discipline for non-compliance

The Resource Guide provides several metrics that organizations will find helpful in analyzing whether employees understand the consequences for non-compliance and whether the discipline imposed in instances of noncompliance is consistent across the organization. The questions in this section also help organizations assess whether incentive and promotion criteria are appropriately aligned with the organization’s healthcare compliance concerns.

Investigations and remedial measures

This section includes metrics that organizations may use to evaluate the effectiveness of compliance investigations, including the independence and competence of the investigators, communication regarding investigations, and whether the organization responds appropriately to compliance concerns.

The Resource Guide represents the most thorough presentation of the OIG’s thinking on compliance program evaluations. As such, it can be used as a starting point for healthcare compliance program assessment tools, regardless of the type of organization conducting the evaluation.

Monitor and Remain Compliant

With healthcare regulations in a constant state of change, compliance now takes more effort than ever. To avoid the potentially crippling fines associated with exclusion screening, organizations need to stay up to date with the latest rules and regulations. There is no time like the present to review the current risk management program and to ensure regular exclusion monitoring.

As the OIG continues to broaden and expand its exclusion authority, healthcare organizations not actively seeking updates to regulatory requirements and exclusion lists can easily become non-compliant. Therefore, it is of utmost importance to monitor all employees and entities regularly and self-disclose any exclusions to the OIG to reduce penalties.

Screening and monitoring large healthcare populations of employees, vendors, and all of the entities in between, can seem to be a daunting task. However, this cannot be avoided because healthcare providers have a duty to screen prospective and current employees against all exclusion databases. What can be avoided are fines and violations. Exclusion screening technology makes it easy to maintain compliance with the OIG, GSA SAM, and other state exclusion and sanction cross-checking lists. With reliable, automated exclusion screening it is possible to both save time and maintain healthcare compliance.