Allegations

The defendants allegedly committed a variety of crimes involving the improper securing of Medicare information from elderly or low-income individuals and the submission of false billings for treatments that never occurred, or were performed by unlicensed individuals. The activity occurred in various health care fields, but most notably in the home health industry. In Miami and Baton Rouge, for example, investigations uncovered multimillion dollar schemes involving a handful of perpetrators that involved bribing beneficiaries for Medicare information and billing Medicare for medically unnecessary services or services that were never rendered. Other cases involved fraudulent billing for power wheelchairs, surgeries that were never performed, and massages by unlicensed therapists. In one notable Detroit scheme, three defendants falsely held themselves out as licensed physicians, conducting examinations, writing prescriptions for drugs, including narcotics, and signing off on psychotherapy documents.

Anti-Fraud Operations

This is the sixth national Medicare fraud takedown coordinated by the Medicare Fraud Strike Force, which was created in 2007. The Strike Force is part of the Health Care Fraud Prevention & Enforcement Action Team (HEAT) initiative that combines the resources of the Department of Justice (DOJ) and HHS. Attorney General Holder stated that Strike Force operations over the last three fiscal years have resulted in recoupment of nearly eight dollars for every dollar spent on combating health care fraud. Additionally, he suggested that Strike Force actions have deterred illegal activity, noting that group psychotherapy bills to Medicare decreased by more than 70 percent after the Strike Force targeted group psychotherapy fraud in Detroit and that billings for home health services in Florida dropped by more than $1 billion after the Miami team targeted home health fraud. Holder expressed concern that sequestration, which cut more than $1.6 billion from the DOJ’s FY 2013 budget and is expected to continue into FY 2014, will reduce the DOJ’s ability to combat Medicare fraud.

What to Look for in the CIA

Health care providers must be proactive in identifying problem areas, Martin said. Reviewing CIAs to determine how OIG and DOJ are analyzing problem areas and who is held accountable within organizations can help health care providers be more proactive in areas of concern. Health care providers should note how OIG and DOJ will track performance and accountability, including but not limited to entity reporting and independent review organizations (IROs) oversight activities. In addition, they should look at the elements of the compliance program that the OIG and DOJ require the entity to establish. In addition to providing valuable information for improving the organization’s compliance program, the CIA includes specific elements of a compliance program that address identified issues such as physician contracts, quality of care, improper referrals, inadequate documentation, and improper billing and coding. One area included in more recent CIAs is Board of Directors participation and training, including individual director certification that the entity is complying with the terms of the CIA. Martin said that compliance officers should stress the importance of  directors’ participation  in and support of the compliance program, noting that they could be held accountable under the Responsible Corporate Officer Doctrine. Quality of care  is another more recent area being addressed in CIAs by the OIG and DOJ. In addition to requirements found in other CIAs, quality of care CIAs have quality-related elements, including the creation of a quality assurance compliance committee, a Board-level quality assurance monitoring committee, an internal audit program for quality, special tracking of temporary staff, and special reporting to the OIG/Monitor.

Mitigating Factors

Typical enforcement actions come under the False Claims Act (FCA) and can be brought either as a civil or criminal FCA, the Anti-kickback Statute, and False Statement, which is a federal crime. An effective compliance program, however, can help mitigate the effects of an enforcement action taken by the DOJ and move a false claim to a simple overpayment, Martin said. Martin recommended that health care providers have arrangement databases with a robust system to track physician contracts and leases of space and equipment that would help prevent anti-kickback and Stark violations. In addition, she recommended strong internal controls, including monitoring and data analytics to identify patterns of billing errors and prevent unintentional improper payments.

Advice for Negotiating and Implementing a CIA

Organizations that have been under CIAs have had issues dealing with implementation, Martin noted. For example, organizations had difficulty identifying who should be considered a “covered person.” Martin included contractors, subcontractors and vendors as covered persons. Another area of concern for such organizations was implementing policies and procedures and meeting training and education requirements. Martin suggested that if an organization will be entering into a CIA, it should include the important organizational players in its development, including lawyers, the chief financial officer, chief executive officer, and the compliance officer. According to Martin, an organization should also consider hiring a subject matter expert to develop terms and requirements and developing a folder on potential IROs to ensure that the organization hires an IRO that has experience in the subject matter area as well as experience with regulators. The organization should also check references before the IRO is hired. Even though the entity hires the IRO, the IRO is really a government agent, Martin stressed.

 Settlement May Not Be the Final Action

Health care providers may begin to see the light at the end of the tunnel once the settlement agreement and the CIA have been entered into by the parties; but that may not be the end. SouthernCare, Inc. (SouthernCare), a hospice provider, entered into a settlement with the DOJ and HHS to resolve allegations of violations of the FCA related to improperly applying eligibility requirements for the hospice benefit. The settlement  resulted in a $24.7 million settlement  and a five-year CIA. Bill Priest, Chief Compliance Officer and Rebekah Plowman, Partner, Jones Day, told SouthernCare’s story to attendees at HCCA’s Compliance Institute on April 23, 2013.  From the outset of the CIA term, SouthernCare, Inc. replaced its compliance program with one that was more aggressive, expedited training and implementation of reporting requirements, and it began to see improvements in IRO mandated annual eligibility reviews. As things improved in years three through four of the CIA, three qui tam suits were unsealed, all dealing with the same covered conduct that was the settlement and CIA. The government declined to intervene but the lawsuits were not dismissed. Plowman explained the Patient Protection and Affordable Care Act (PPACA) (P.L. 111-148) amended the public disclosure bar provisions of the FCA to limit much of the authority for courts to dismiss actions based on prior disclosure of the covered conduct. Now it is sufficient to have knowledge that is independent of, and materially adds to, the publicly disclosed allegations. The presenters noted that health care providers can protect themselves by aggressively and consistently complying with CIA provisions and applicable regulations; vigilant auditing and monitoring of claims and patient charts, hotline calls/complaints, and employee actions; taking appropriate action in a timely manner; open communication with the OIG and DOJ; and good counsel.

1. The GSA debarment list was never intended to be used by health care providers and plans. The Excluded Parties List System (EPLS) is now part of the System for Award Management (SAM) and is designed solely for use by Federal government agencies’ procurement process.  Just go to their website and see that.  With rare exceptions, health care providers and plans are not Federal agencies or part of any Federal procurement process. The GSA debarment list is designed to prevent Federal government agencies from soliciting offers from, and awarding contracts, grants, or financial or non-financial assistance and benefits to those on the list.  
2. GSA sanction screening has never been user friendly. It also generates many “false hits” that result in considerable work to make determinations as to whether the entity in question is identifiable to the one on which the hospital is checking.
3. The GSA does not offer any useful assistance in trying to verify a potential “hit.” Unlike the OIG LEIE that has verification tools available to assist with possible hits, the EPLS often lacks solid identifiable information to permit easy verification that the party listed.  This problem is further complicated by the large number of entities with similar sounding names.
4. The GSA is complicating an already difficult sanction screening process. The new operational bugs that recently surfaced with the GSA SAM database included some security breaches for users, along with data discrepancies.  These new problems resulted from GSA consolidating a number of federal procurement processes related to government contracting. Its new system consolidates several databases into one online system. They include the Central Contractor Registration/Federal Agency Registration (CCR/FedReg), Online Representations and Certifications Application (ORCA), and the EPLS.  Future phases of SAM will include additional databases for use during government procurement processes.
5. There is no provision or guidance for health care providers or plans to consider administrative debarments discretionary. The GSA lists two types of debarments:  mandatory and administrative.  Federal agencies have the discretion of contracting with those on administrative debarment.  There is no guidance by CMS or any other federal agency as to whether that discretion applies to health care entities.
6. The overwhelming majority of entities on the EPLS are not relevant to health care entities. It makes some sense to conduct sanction screening of health care-related contractors or vendors, but most hospitals have thousands of other types of entities providing everything imaginable for running any business, such as printing paper, toilet paper, computer supplies, delivery services, ground keeping services, trash hauling contractors, accounting and legal services, and on and on.  All one has to do is to look at the accounts payable and see that the list can be neverending.  Yet, there is no guidance as to where to draw the line for sanction screening. 
7. There are no specific CMS regulations requiring providers to screen against the GSA debarment list. However, the 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 and the GSA. Also, under 42 CFR § 424.516(a)(3)(ii), providers may not contract with any individuals or entities that are debarred by the GSA as a condition to maintaining active enrollment status.  CMS also requires managed care plans to screen against the GSA EPLS 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. Additionally, debarred providers who apply for Medicare shall be denied and debarred providers enrolled with Medicare shall have their Medicare billing privileges revoked. 
8. Sanction screening against the GSA database is not very cost effective.  Although “hits” as result of sanction screening against the EPLS are not uncommon, legitimate one are very uncommon.  What this means is that the effort level is high for screening against the GSA data; and the return on effort is very low.
9. Screening individuals and entities who are unrelated to health care delivery of services and products does not make much sense. It particularly makes little sense to run IBM, Staples, a courier service, computer repair services, etc. through the EPLS.
10. The cost versus benefit equation of sanction screening against the EPLS is poor. It particularly makes little sense to run entities such as IBM, Staples, courier services, computer repair services, etc. through the EPLS.
11. The OIG has added its LEIE data to the SAM, creating a redundancy.  As such, the only likely confirmed hits on the GSA database would those parties that were already listed on the LEIE, and the LEIE is the primary source.  Once again the relative value of sanction screening against GSA data is limited.  There are lag times from when an OIG sanction appears on the SAM and when it is removed.  What this means is that it is possible that an exclusion may have been rescinded by the OIG, but GSA may still carry it on their debarment list.  This lag time can be considerable.
12. Unlike screening against the LEIE, the OIG only suggests the GSA data as a useful resource.  It does not see failure to screen as creating a liability or potential fraud.   CMS is alone in believing a health care organization should terminate a contract with the debarred party, regardless of the vagueness of what that party might be or the nature of the debarments. 
13. It is not clear how an entity would deal with a finding of a debarred party. It is neither an OIG nor DOJ issue and they would not be involved.  I would question the legal basis or reasonableness for cancelling valid contract just because CMS thinks it is should be done.

In a future blog article, I will offer some suggestions to mitigate the GSA sanction screening burdens.

Richard P. Kusserow served 11 years as the DHHS Inspector General and currently is CEO of the Compliance Resource Center (CRC), including Sanction Screening Services (S³), which provides sanction screening tools and also provides full outsourcing of sanction screening. For more information, he can be contacted at rkusserow@strategicm.co.

Copyright © 2013 Strategic Management Services, LLC.  Published with permission.

Criminal Case

Ranbaxy operates manufacturing facilities in Paonta Sahib and Dewas, India. It admitted that it introduced multiple batches of adulterated products produced at those facilities into interstate commerce. The products included Sotret, a branded version of isotretinoin used to treat severe recalcitrant nodular acne; gabapentin, used to treat epilepsy and nerve pain; and ciprofloxacin, a broad-spectrum antibiotic. Under the Food, Drug and Cosmetic Act (FDCA), a drug is adulterated if it undergoes various manufacturing and related processes that do not conform to, or are not operated or administered in conformity with, current Good Manufacturing Practice (cGMP) regulations. FDA inspection of the facilities revealed incomplete testing records and inadequate programs to assess stability characteristics of drugs, which determine whether drugs can be sufficiently stored to last for a specified time period. The FDA also noted poor cGMP practices at one facility, which Ranbaxy was already aware of, due to reports from private consultants. Ranbaxy failed to file timely field alerts to the FDA to notify it of batches of drugs that had failed particular tests, instead continuing to distribute the batches for months. The manufacturer also made false, fictitious, and fraudulent statements to the FDA in annual reports, improperly conducting tests and lying about the dates of testing.

Civil Case

Ranbaxy was also the subject of a civil lawsuit triggered by an executive whistleblower, Dinesh Thakur, alleging that Ranbaxy, knowing that its drugs’ strength, purity, or quality differed from specifications, knowingly caused false claims to be submitted to numerous government health care programs, including Medicaid, Medicare, TRICARE, and the U.S. Agency for International Development (USAID). To settle the case, Ranbaxy agreed to pay $350 million, of which $118.2 million will be awarded to participating states. Ranbaxy has not imported drugs from the Paonta Sahib and Dewas facilities since the FDA issued an Import Alert in 2008. As part of the settlement agreement, however, Ranbaxy also agreed to an injunction preventing drugs from those facilities from entering the U.S. market until the facilities fully comply with the FDCA and its implementing regulations.

To further complicate the issue, a physician’s decision to admit a beneficiary as an inpatient can challenged and changed retroactively by a Medicare administrative contractor (MAC) or recovery audit contractor (RAC). The Part A payment may be denied even after the beneficiary has received post-hospital SNF care, greatly increasing the beneficiary’s liability with little or no way to appeal the contractor’s decision.

The confusion surrounding the choice between admission and observation has led to at least one lawsuit now underway in a federal district court in Connecticut. The HHS Office of Inspector General (OIG) is studying how much Medicare and beneficiaries paid for observation and related services in 2011 and the extent to which hospitals inform beneficiaries about observation services. And now CMS is proposing a formal definition of inpatient admission that would replace the current vague standard for deciding who is and who isn’t an inpatient.

Observation vs. Inpatient Admission

  Under current CMS policy, “an inpatient is a person who has been admitted to a hospital for bed occupancy for purposes of receiving inpatient hospital services. Generally, a patient is considered an inpatient if formally admitted as inpatient with the expectation that he or she will remain at least overnight and occupy a bed even though it later develops that the patient can be discharged or transferred to another hospital and not actually use a hospital bed overnight.” (Medicare Benefit Policy Manual, Pub. 100-02,  ch. 1, §10.) Observation services are short-term treatments and assessments that hospitals use to determine whether a beneficiary should be admitted as an inpatient or discharged. (Medicare Claims Processing Manual, Pub. 100-04, ch. 4, § 290.1.)

CMS noted in its fiscal year 2014 proposed rule for the inpatient prospective payment system (IPPS) that the number of cases of Medicare beneficiaries receiving observation services for more than 48 hours had increased from about 3 percent in 2006 to about 8 percent in 2011. CMS said that this increase is partially attributable to the fact that MACs and RACs are increasingly denying inpatient determinations when they review hospital claims, and hospitals, in trying to avoid the cost of a later denial, are holding patients for longer periods of time for observation rather than admitting them.

CMS noted that beneficiaries who are treated for extended periods of time as hospital outpatients receiving observation services may incur greater financial liability than they would if they were admitted as hospital inpatients. In addition to the Part B copayment and any drugs not covered under Part B, the beneficiary is liable for the cost of post-hospital SNF care because Soc. Sec. Act sec. 1861(i) requires a prior three-day inpatient hospital stay to cover SNF care. In contrast, if the beneficiary was considered an inpatient, he or she would pay a one-time deductible for all hospital inpatient services provided during the first 60 days in the hospital, and a subsequent transfer to a SNF would be covered by Medicare Part A.

Bagnall v. Sebelius

In November 2011, a group of Medicare beneficiaries who had been hospitalized and then later discharged to SNFs only to discover that their nursing home stays were not covered by Medicare because they were considered to be under observation, as opposed to admitted, by the hospital, filed suit in the district court of Connecticut. The seven plaintiffs in Bagnall v Sebelius all incurred unexpected Part B coinsurance charges as well as thousands of dollars each in nursing home costs. A hearing in the case was scheduled for May 10, 2013.

The complaint notes that the beneficiaries were deprived of Part A coverage to which they were entitled, and thus forced to bear the financial responsibility for hospitalization and prescription drugs that are covered under Part A. They were then denied the right to coverage of their skilled nursing care, which in turn forced them either to pay the cost of that care or to be unable to obtain that care at all. Finally, the complaint notes that the beneficiaries did not receive notification of their observation status, and did not have any right under current Medicare law to appeal that status, depriving them of administrative review of their placement in observation status.

The beneficiaries want the court to decide if CMS’ policy of allowing hospitals to impose observation status on Medicare beneficiaries — even reversing a physician’s order to formally admit a beneficiary — violates the Administrative Procedure Act, the Medicare statute, the Freedom of Information Act, and the Due Process Clause. The class action includes all Medicare beneficiaries who, on or after January 1, 2009, have had or will have had any portion of a stay in a hospital treated as observation status and therefore not covered under Medicare Part A.

A recent report from the American Hospital Association  noted that patients who are admitted to a hospital from the emergency department (ED) are counted as inpatients rather than ED outpatients. However, as Medicare contractors, particularly RACs, have rejected more claims for inpatient services on the ground that they should have been furnished as outpatient services, hospitals have kept ED visitors in observation status more often and for longer periods of time. Patients in observation status receive many more services than other ED patients, and are those exposed to more out-of-pocket costs than beneficiaries admitted as inpatients.

The 2013 OIG Work Plan

As part of its work plan for 2013 the HHS OIG will examine the use of observation services from 2008 to 2011 and the characteristics of beneficiaries receiving observation services in 2011. OIG will determine how much Medicare and beneficiaries paid for observation and related services in 2011 and the extent to which hospitals inform beneficiaries about observation services.

CMS’ Proposal

CMS is proposing a specific definition for inpatient admissions as part of the IPPS update for fiscal year 2014 (see pgs. 657 to 681 and pgs. 1106 to 1108). The proposal states that hospital inpatient admissions spanning at least two midnights (i.e., more than one Medicare utilization day), would presumptively qualify as appropriate for payment under Medicare Part A. Conversely, those admissions that are less than two midnights would be inappropriate for Part A payment. This change is meant to provide more guidance on when a patient is paid as an inpatient under Medicare, which has left many beneficiaries having a longer outpatient hospital stay due to the hospital’s uncertainly about Medicare payments.

CMS also is proposing this standard as a benchmark for medical review of inpatient admissions: Medicare contractors would presume that hospital inpatient admissions are reasonable and necessary for beneficiaries who receive care over two midnights. Hospital services provided over a period of less than two midnights will be presumed to be provided on an outpatient basis. These proposals, if finalized, would go into effect October 1, 2013.

The strategies were outlined in a 2011 report, Hospitals and Care Systems of the Future, which described the need to move toward a focus on performance and evidence-based practices as the basis for reimbursement moves to a focus on the value of the care provided in terms of its effect on the patient’s health. The four strategies emphasized in Metrics are: (1) aligning hospitals, physicians, and providers to work together across the “continuum of care”; (2) using evidence-based practices to improve quality and patient safety; (3) boosting efficiency through financial management and productivity; and (4) developing integrated information systems.

Alignment Across the Continuum

The first strategy involves a movement of providers and practitioners from separate silos to accountable care organizations (ACOs) or patient-centered medical homes (PCMHs). Success is measured, in part, in terms of the extent to which physicians are engaged in the effort. The expectation is that contracts will include performance-based incentives. The ACO or PCMH will coordinate the care of each patient, emphasizing the management of chronic conditions. Clinicians will increasingly exercise leadership roles.

Use of Evidence-Based Practices

This second strategy includes involving the patient in planning his or her care and paying particular attention to the management of care transitions, such as discharge from hospital to home or rehabilitation, to minimize readmissions and visits to emergency departments. Variations in utilization are measured and analyzed to fill the gaps that may lead to hospital admissions or emergency department visits.

Efficiency, Productivity, and Financial Management

Because reimbursement will be based on an episode of care rather than the volume of services provided, hospitals will have to develop goals to cut costs and manage foreseeable risks. Under performance-based contracts, the providers and professionals operating through ACOs and PCMHs will share the financial risks and any savings generated.

Integrated Data Systems

Patient records will be maintained electronically in an integrated data warehouse. All participants in the continuum of care will have access to the records to have a clear picture of each patient’s needs. In addition, data mining will be used to analyze the health of the patient population as a whole and any emerging disease patterns.

The AHA has developed a survey for providers to use for a self-assessment of their current state and measurement of their progress.

Certainly, interoperability is crucial to the ultimate success of the EHR initiative. Because many hospitals build their information technology (IT) systems piecemeal, interoperability issues arise among databases in the same institution. The lag can slow down EHR systems and increase risk to patients. A physician who presented a paper at a convention of nephrologists in November 2012 found that all the physicians he surveyed in his hospital’s intensive care unit (ICU) experienced “cognitive drift” when their hospitals’ systems failed to respond as promptly as they expected, In other words, they stopped paying attention to the computer. Sometimes, they even left the computer altogether. And the length of time from the click of the mouse to the drift was ten seconds. In April 2010, when an automatic anti-virus software update incorrectly caused uncontrolled restarts of computers and loss of network functionality, one-third of the hospitals in Rhode Island had to postpone elective surgeries and divert “non-life-threatening emergencies.”

Writers who analyzed the relationship between EHR and national patient safety goals in the New England Journal of Medicine in November 2012 suggested a three-phase approach to EHR safety issues. In the first phase, the focus is on new safety issues presented by the technology. To prevent or minimize the effects of an incident like the one in Rhode Island, they recommend setting an EHR-specific patient safety goal (ePSG) of reducing the effects of EHR downtime on clinical operations and patient safety.  Another phase one ePSG might be to reduce medication errors that result from the mismatch of data fields between the sender and recipient of an e-prescription, for example, elimination of “sustained release” from the description of a prescribed drug.

The second phase addresses the potential harm that could result from incorrect or inappropriate use of the technology. For example, the  use of CPOE, in some departments or for some orders but not others, could create a risk to patients because of the ease with which an order might be overlooked if clinicians have to check multiple locations.  Other issues that might arise during the second phase include inconsistent use of free-text or structured data fields. When the structured data fields are available but a physician puts a key element of the order in free text, such as a date to discontinue medication, the chances of miscommunication are magnified.  The designers and users of clinical decision support systems might have to analyze the work flow to assure that alerts or automatic stops are generated at the optimal times, to prevent “alert fatigue” and inappropriate overrides of the system as well as  clinical error.  They also could consider addressing the copy-and-paste problem because unnecessary copying and pasting of history notes or other material actually has been found to detract from the usability of an EHR.

Only in the third phase would the safety focus turn to the functions that take advantage of the ability to mine the data for root causes of adverse events of the data. The authors urged that the teams that design and refine EHR systems include cognitive scientists and human-factor engineers as well as physicians who would have to use the system.

Currently, there are no licensed drugs that can slow the progression of Alzheimer’s, and currently approved medications only  treat the symptoms of the disease. Alzheimer’s is the most common form of dementia, affecting 5.1 million Americans according to the National Institutes of Health. The disease progresses in three stages—an early, preclinical stage with no symptoms, a middle stage of mild cognitive impairment,  and a final stage of Alzheimer’s dementia. The time from diagnosis to  death varies—as little as 3 or 4 years if the person is older than 80 when diagnosed to as long as 10 or more years if the person is younger.

In the Baxter trial, patients who received 18 months of infusions with the drug Gammagard fared no better than a group of patients who were given a placebo. Data indicated that the drug did not significantly arrest the decline in either cognition or daily functioning when compared with a placebo.

Just last year, researchers reported that four patients who had received the maximum dose of Gammagard had unusually gone three years without any decline in several measures of cognition and daily functioning. Unfortunately, the small Phase 2 patient pool did not have the same observable results when expanded into the Phase 3 trial.

Baxter noted that it would discontinue other trials testing the drug as a treatment for mild to moderate forms of Alzheimer’s, as well as reassess its program to study the disease once a full analysis of the data derived from the study is completed.

Membership is to be composed of 15 individuals and include physicians and health care professionals from various health care professions and regions of the country. On March 29, 2013, President Obama requested recommendations for IPAB membership from Speaker Boehner and Leader McConnell. In their joint response, they stated that “because the law will give IPAB’s 15 unelected, unaccountable individuals the ability to deny seniors access to innovative care, we respectfully decline to recommend appointments.”

The letter went on to state that the leaders hope that establishing the IPAB never becomes a reality as a full repeal of PPACA remains the goal of both leaders. According to the letter Speaker Boehner and Leader McConnell believe that they should “work in a bipartisan manner to develop the long-term structural changes that are needed to strengthen and protect Medicare for today’s seniors, their children and their grandchildren.” It is anticipated that the House will again set up to vote on repealing PPACA in the near future.

In its Bulletin, the OIG contrasted the LEIE with the GSA’s EPLS, which was recently merged into the Systems for Awards Management (SAM).  The OIG appears to have put a little distance between itself and CMS regarding screening against the EPLS. The OIG noted that in January 2009, CMS issued final regulations (42 C.F.R. sec. 455.436) mandating states to screen all enrolled providers monthly against both the LEIE and EPLS.  This is in contrast to the OIG’s position.

The key points laid out by the OIG on this subject are as follows:

1. The OIG stated the LEIE lists only exclusion actions taken by the OIG and that it provides the LEIE information to GSA, which is incorporated into the system. 
2. The LEIE should be considered the primary source for reporting any “hits” to the OIG.
3. In contrast to the GSA debarment list, the OIG exclusion does not affect a person’s ability to participate in other Government procurement or non-procurement transactions. 
4. The OIG stated it has no authority to impose civil monetary penalties on the employment of a debarred person appearing on the GSA EPLS.

Final note: It is worthwhile to remember that CMS has not established any enforcement mechanism to deal with providers that have relationships with parties on the debarment list. With the foregoing in mind, I continue to suggest that providers limit the screening against the EPLS to a bare minimum, as required.

Richard P. Kusserow served 11 years as the DHHS Inspector General and currently is CEO of the Compliance Resource Center (CRC), including Sanction Screening Services (S³), which provides sanction screening tools and also provides full outsourcing of sanction screening.  For more information, he can be contacted at rkusserow@strategicm.co.

Copyright © 2013 Strategic Management Services, LLC.  Published with permission.