A Provider’s Guide to OIG Exclusions: Part 2

Provider's guide to OIG Exclusions

Federal Exclusion Regulations and Enforcement Authorities, and How Providers Can Avoid Risk with Proper Exclusion Screening–Part 2

Paul S. Weidenfeld, JD

This article was originally written by Paul Weidenfeld and published by GreenBranch Publishing.  This article is Part 2 from a 2-Part article originally published by GreenBranch Publishing on their website.

Office Inspector General of (OIG) exclusions are one of the most powerful weapons available to law enforcement in its effort to fight healthcare fraud. Individuals and entities subject to an OIG exclusion are barred from participation in all federal healthcare benefit programs, resulting in a payment prohibition on all items and services they provide, whether directly or indirectly. Additionally, providers that employ or contract with excluded individuals or entities risk the imposition of civil money penalties, overpayment liability, and even potential exposure under the False Claims Act. However, even though OIG exclusions also are one of law enforcement’s oldest tools, many providers often fail to appreciate their compliance obligations with respect to exclusions and the risks associated with employing or contracting with excluded individuals or entities. Indeed, many providers make only minimal efforts to screen their employees and contractors to ensure compliance—and some make no effort at all. This article seeks to educate providers on the existing legal and regulatory framework, the risks and potential consequences of a failure to comply with those laws and regulations, and how best to comply and avoid those risks.

ENFORCEMENT OF OIG EXCLUSION VIOLATIONS

he Office of Inspector General (OIG) credits the 1999 Special Advisory as the “beginning” of its initiative to ensure compliance and enforcement of exclusions (2013 Special Advisory, at pg 2), but the updates to the OIG’s Self-Disclosure Protocol and its Special Advisory on the Effect of Exclusions in 2013 more accurately mark the beginning of the OIG’s focus on exclusion enforcement.[1] Before the Special Advisory was updated, for example, the OIG routinely suggested that providers screen employees and those with whom they had contracts on an annual basis, whereas the Updated Advisory requires monthly screening of a significantly expanded universe of persons and entities. And until the OIG issued its Updated Self-Disclosure Protocol only weeks earlier, there was no established protocol for providers to self-disclose exclusion violations. Read together, and in conjunction with the investigation and repayment obligations in the Affordable Care Act (ACA), these three principles form the foundation upon which exclusion enforcement is based.

Enforcement matters come to the OIG’s attention in a variety of ways. In addition to its inherent authority to initiate investigations, the OIG receives hotline tips, referrals from its sister agencies,[2] referrals from various CMS contractors, self-referrals from providers wishing to avoid civil monetary penalties (CMPs), and whistleblower actions, to name just some. With respect to exclusion enforcement, however, the OIG historically has relied heavily on self- disclosures. Indeed, until the 2013 Updates, the OIG rarely initiated investigations based on exclusion violations on its own. In the years leading up to the 2013 Updates, the OIG reported the following numbers of exclusion settlements based on an investigation it had initiated: seven in 2010; three in 2011; ten in 2012; and none in 2013 prior to the publication of the updates.

Since 2013, however, some change has been evident. The number of reported settlements based on OIG investigations increased to a high of 26 in 2015; both the Office of Evaluations and Inspections and the Office of Audit have reported separate “exclusion initiatives”; and in 2015, the OIG established a special litigation unit that focused on the imposition of civil monetary penalties and exclusions.

Many providers are under the mistaken impression that the OIG’s enforcement efforts are focused on physicians and other direct billers, and therefore think that their credentialing process adequately screens for exclusions. This can be a costly mistake.[3]

Figure 1:
Table 1:

Figure 1 reflects OIG enforcement efforts in cases in which the agency initiated the investigation. It shows the OIG’s focus on institutions that provide a lot of care and then submit a lot of claims for that care.

Table 1 shows that the OIG’s enforcement net extends far wider than doctors and other direct billers. Although there is an emphasis on non-billing, direct care providers, the chart shows that no position is “safe” when it comes to imposing CMPs for excluded employees.

Although the imposition of CMPs is the favored enforcement methodology, a growing number of cases involving exclusions have resulted in False Claims Act (FCA) cases and criminal convictions. For example, a joint federal/state investigation in Tennessee involving an excluded private duty nurse who worked for a home health agency resulted in a $6.5 million settlement. In addition, the OIG has brought a number of FCA cases in which the principal allegations involved businesses operated by excluded persons

Finally, recent enforcement efforts with respect to the requirement that providers ensure the exclusion status of physicians, pharmacies, and labs at the point of service have been increasing. This has resulted in a number of settlements with pharmacies based on the employment of excluded pharmacists or excluded support personnel. For example, in one of the settlements, a pharmacy chain paid $21.5 million in settlement because it had employed a large number of excluded pharmacists.[4] States also have taken an interest in this issue; for example, the Attorney General of New York settled with a pharmacy for $442,000 to resolve allegations that the pharmacy had been fulfilling prescriptions written by an excluded physician.

AVOIDING CIVIL MONEY PENALTIES AND OVERPAYMENT LIABILITY: COMPLIANCE WITH FEDERAL EXCLUSION SCREENING REQUIREMENTS

Exclusion enforcement is based on the simple principle that providers are responsible for ensuring the exclusion status of their employees and those with whom they do business. As a consequence, claims for items or services furnished by excluded individuals or entities result in regulatory violations subject to the imposition of civil money penalties, and all federal reimbursements for such items or services violate the payment prohibition and constitute overpayments.[5] Only proper exclusion screening can help providers avoid these risks, and this section seeks to help providers understand their federal screening obligations. Much of the content in this section relies on the guidance contained in the 2013 Special Advisory,[6] but it relies as well on subsequent guidance issued by the OIG, and on Corporate Integrity Agreements (CIAs) that have been imposed by the OIG as part of recent False Claims Act settlements.[7]

Which Employees Should be Screened for OIG Exclusions?

Employees must be screened for exclusions if they furnish any item or service that is payable directly or indirectly, whether in whole or in part, by a federal healthcare program. The OIG recommends the following process for providers to use in determining which employees should be screened:

Review each job category or contractual relationship to determine whether the item or service being provided is directly or indirectly, in whole or in part, payable by a federal healthcare program. If the answer is yes, then the best mechanism for limiting CMP liability is to screen all persons that perform under that contract or that are in that job category. (2013 Special Advisory, at 15-16).

Because all the relevant terms are broadly defined (see footnote 9 and pages 2 and 3, infra,) and as the process is as time-consuming and difficult to follow as it is broad, providers are best served by screening all of their direct employees unless they can identify specific employees who work in a separate, identifiable division wholly unrelated to federal healthcare programs. Caution dictates against “picking and choosing” who to screen unless a “quarantine” can be guaranteed.[8] In addition, corporate integrity agreements include owners, officers, directors, managing employees, agents, and active medical staff as those who should be screened regardless of whether they are employed directly or indirectly.

Exclusion Screening of Vendors and Contractors

The OIG suggests that providers use the same analysis in determining “whether or not to screen contractors, subcontractors, and the employees of contractors” that it uses for its own employees. This standard is unrealistic in many circumstances, and although the OIG does not acknowledge the difficulty of its suggestion, it goes on to states that “The risk of potential CMP liability is greatest for those persons that provide items or services integral to the provision of patient care because it is more likely that such items or services are payable by the Federal health care programs.” (See 2013 Special Advisory at 16.) The dual focus of patient safety and program integrity was again emphasized in the amendment of CMP rules in 2017. The new 2017 rules are a valuable guide in determining whom to screen.

The CMP authorities in this part, as a general matter, aim to redress fraud on the federal health care programs by recovering funds, protecting the programs and beneficiaries from untrustworthy providers and suppliers, and deterring improper conduct by others. Accordingly, it is highly relevant if the conduct put beneficiaries at risk of patient harm (81 Fed. Reg. 88, 334 (Dec. 7, 2016)).

CIA’s from OIG settlements can contain indirect acknowledgments by the OIG as to the broad nature of the screening obligation is outlined in the guidance. In most of these documents, there is a specific provision stating that providers do not need to screen vendors whose sole connection to the provider is selling or providing supplies or equipment for which the vendor does not bill. This is a common-sense exception that removes uncertainty with regard to a large class of vendors who provide supplies for which the provider is ultimately reimbursed.

Applying the guidance and understanding of the concerns of the OIG, the contractors and vendors who are likely candidates for exclusion screening are those that provide the following services:

  • Ambulance and other transportation service providers;
  • IT solution providers;
  • Security providers and their technicians;
  • Medical equipment suppliers;
  • Food service workers;
  • Lab technicians;
  • Billers and coders;
  • Pharmacists;
  • Nurses, physicians, and other individuals provided by staffing agencies; and
  • Physician groups that provide emergency room coverage.

For obvious reasons, the OIG is highly focused on screening billers and third-party billing companies. In most CIAs, OIG will only allow providers to delegate the exclusion screening function to their billing company if it does not have an ownership or controlling interest in the billing company and it certifies that the following conditions have been met:

  1. The billing company has a policy of not employing persons who are excluded, suspended, or otherwise ineligible to participate in Medicare or other federal healthcare programs;
  2. The company screens its employees upon hire and monthly thereafter against the List of Excluded Individuals/Entities (LEIE);
  3. The company provides proof of its screening activities; and
  4. The billing company provides training in the applicable requirements of the federal healthcare programs to those employees involved in the preparation and submission of claims to federal healthcare programs.

 

How Often Should Providers Screen?

Providers are responsible for ensuring the exclusion status of employees, vendors, and contractors at all times and at the point of service, and they should screen accordingly. Thus, exclusion screening should be performed prior to employment or to the initiation of a business relationship. Exclusion screening also should be performed without regard to the person’s status or “whether or by whom” exclusion screening had previously been performed.

In order to ensure ongoing compliance with the obligation to ensure an “exclusion free” workforce, screening also must be performed “regularly” thereafter. Providers sometimes question the necessity of ongoing screening, but the reasons for it are obvious: exclusion is not a static condition, and someone who is not excluded at the time of hire can certainly become excluded at a later date. This is particularly the case if an exclusion is based on a licensing action that was pending at the time of employment but not resolved until sometime after the employment relationship began. Also, and perhaps most importantly, regular screening is required.

Although there are no statutes or regulations that expressly state exactly what constitutes “regular screening,” the OIG has unequivocally expressed its view that monthly screening “best minimizes potential overpayment and CMP liability” (2013 Special Advisory at 15). In addition, the OIG notes that in June of 2008, CMS issued a State Medicaid Director Letter (SMDL #08-003) that provided guidance to Medicaid directors on checking providers and contractors for excluded individuals,[9] and that CMS issued a follow-up directive in 2009 (SMDL #09-001) providing further guidance to the states and, essentially, mandating that screening be done upon hire and monthly thereafter.[10] The OIG also notes that LEIE is updated monthly. Finally, there is the practical consideration that removing an excluded employee as soon as possible is the best action a practice can take for business.[11]

Which Federal Exclusion Lists Should be Screened?

The OIG requires that providers screen its LEIE. It does not, however, require providers to screen the Government Service Administration’s System for Award Management (GSA/SAM), because the OIG has no authority to impose penalties or assessments based on an individual’s or entity’s inclusion on a separate federal agency’s debarment list or on a state exclusion or debarment list.

Although searching the LEIE can satisfy the OIG’s screening requirement, providers that participate in state Medicaid Programs should understand that every state has its own set of exclusion regulations and exclusion screening requirements. Indeed, at last count, 40 states had their own exclusion lists, which had to be screened in addition to the LEIE. Medicaid providers need to consult the relevant rules and regulations in the state, or states, in which they participate.[12]

It is also noted that Section 6501 of the ACA specifically states that if a provider or entity is excluded from any state Medicaid program, then that provider or entity is excluded from participating in all state programs (42 U.S.C. § 1396(a)). Although it has not been fully settled as to how the statute will be implemented, it is worth noting and considering when determining which databases to screen. Many screening services routinely screen all such databases instead of screening individual states.

Additional Recommended Practices

The following policies and procedures are all found in either CIAs or other materials published by the OIG. They are not required, but they do reflect practices that providers might consider including as part of exclusion screening program:

  • Have a provision on maintaining documentation of its exclusion screening activities in its document retention policy;
  • Have a written policy requiring the disclosure of any exclusion or any other adverse action that occurs during the course of their employment, including any state exclusions, suspensions, licensing actions, revocations and debarments; and
  • Have a written policy requiring employees to report the existence of any pending or proposed exclusions or adverse action that might cause an exclusion.

THE SCREENING PROCESS

How Difficult Is It to Actually Screen?

The actual process of screening employees, vendors, and contractors against the LEIE is a cumbersome one. Providers can either manually input names into the OIG website or download the entire exclusion list from the website and compare it with their employee list—but both options provide significant challenges. If a provider decides to manually input the names, for example, he or she is limited to five names or four entities at a time. Any potential match requires an additional step for confirmation, and unless the submitted name is an exact match with the name in the LEIE, it will not register as a potential exclusion. Providers that elect to download the entire list, the other option, also face serious challenges. There are over 65,000 names on the LEIE, and many providers simply don’t have the technical expertise to compare lists—particularly where the names may not result in perfect matches. In addition, the OIG requires that the screening process be documented by screenshots or otherwise, which would not be easily accomplished by either screening methodology.

Can Providers Rely on Others to Screen?

The OIG recognizes that providers will sometimes seek to delegate their screening obligation to contractors such as staffing agencies. When that occurs, the OIG again advises the provider to demand and maintain documentation that the screening was performed, and it also reminds providers that a delegation of the responsibility to screen does not equate to a delegation of the liability attached to that obligation. For example, the OIG states in its 2013 Advisory that even when a third party reliably and effectively screens for excluded individuals, those that rely on them are still “responsible for overpayments and CMPs” (at page 8).

Regardless of whether and by whom screening is performed and the status of the person . . . the provider is subject to overpayment liability for any items or services furnished by any excluded person for which the provider received federal healthcare program reimbursement and may be subject to CMP liability if the provider does not ensure that an appropriate exclusion screening was performed (2013 Special Advisory, at 16).

Does It Make Sense for Providers to Hire a Third-Party Vendor to Perform Screening?

Hiring a third-party vendor to screen for exclusions does not solve all of a provider’s screening issues and problems, but it is a relatively inexpensive alternative that solves most of them. Reputable exclusion screening vendors can do all of the work inherent in screening, including the verification of potential matches, so that providers don’t need to waste employee time manually entering tens (or hundreds, or thousands) of names. These vendors should have sophisticated software that is able to identify “potential matches” when names are not a “perfect match,” and they should also maintain records of all screening activities. Another important advantage of having a vendor perform exclusion screening is that they should be able to screen the various state exclusion lists at little or no additional cost. Finally, even though a provider cannot delegate its overpayment liability, having a third party that regularly screens all names can provide strong defenses against the imposition of any civil money penalties.[13]

SELF-DISCLOSING EXCLUSION VIOLATIONS

The OIG’s updated Self-Disclosure Protocol issued added a new section for self-disclosing exclusion violations and a formula for calculating single damages.[14] In addition to creating a path for self-disclosures and injecting some certainty into the process, the updated protocol clarified the OIG’s expectation that providers fully comply with exclusion regulations and its intention to enforce the exclusion regulations if providers fail to do so.

The protocol requires that providers fully investigate the matter and submit their findings in a narrative that includes the following information:

  • Identification information regarding the excluded individual, including license and provider identification information (if any);
  • Job duties, and their dates of service;
  • A description of the screening that took place both prior to and after employment began;
  • How the problem was discovered or and the corrective actions taken; and
  • A calculation of the loss (see following section).

Calculation of the “Loss”

Prior to the update, calculating the “loss” for exclusion violations was particularly problematic if the employee provided services that indirectly contributed to the submission of a claim but were not billable in of themselves (e.g., nurses, surgical assistants) or if the employee provided

services that supported the organization but were not connected with any specific claims (e.g., administrative, IT, or housekeeping services). Providers were at a loss when attempting to calculate the single damages of exclusion violations associated such individuals. To calculate the loss for an excluded shift supervisor, would every service provided during every shift while the shift supervisor was employed be tainted and constitute an overpayment? How would one calculate the overpayment amount for a biller or coder, or a coding or billing supervisor?

The revised protocol directly addressed this issue of how to self-disclose by creating a simple, workable methodology that could be used to generate an amount, which would then serve as a proxy for the single damages. Specifically, the formula requires providers to do the following:

  1. Identify the total cost of employment for the excluded person or persons (including benefits, etc.) during the period of employment;
  2. Calculate the provider’s payer mix (by the unit in which the person worked if possible, or by the entire entity if not); and
  3. Simply multiply the cost by the federal mix.

The result can then be used as a “proxy” for the single damages and as a basis for “compromising the OIG’s CMP authority.” Because the calculation considers the contribution of the excluded employee during the exclusion period and the extent of the federal contribution to the organization, it provides a generally proportionate result in matters involving non-billing employees that provide services that contribute to claims to federal healthcare payers.[15]

REINSTATEMENT

Reinstatement at the conclusion of an exclusion period is not automatic. Applications may be submitted 90 days prior to the reinstatement date. However, in many permissive exclusions, the reinstatement date is dependent on external factors that are unknown at the time of the exclusion. For example, when a person is excluded based on a license revocation, he or she is not eligible for reinstatement until he or she has regained the license referenced in the exclusion or an equivalent license in another state. Alternatively, if the person does not regain his or her license, he or she may seek reinstatement if a minimum of three years has passed and the action was not based on patient abuse or neglect (42 CFR § 1001.501(b)-(c)). An OIG exclusion based on a state healthcare program exclusion also is linked in length to that action, but a person subject to an exclusion on this basis is not eligible for reinstatement until the state exclusion is lifted—unless the basis of that action was an OIG exclusion in the first place (42 CFR § 1001.601(b)).

If the OIG determines that the provider is eligible for reinstatement, the OIG will send the provider a number of forms and releases of information to be completed, notarized, and returned. In evaluating reinstatement requests, the OIG considers the following:

  • Conduct of the individual or entity prior to, and after, the exclusion;
  • Whether there are reasonable assurances that the conduct that formed the basis for the original exclusion will not recur;
  • Whether all fines and all debts due have been repaid or if there are satisfactory arrangements for those that have not ;
  • The benefits of reinstatement to federal healthcare programs and its beneficiaries; and
  • Whether CMS has determined that the individual or entity complies with, or has made satisfactory arrangements to fulfill, all the applicable conditions of participation (42 C.F.R. § 1001.3002).

Once it has completed its review, the OIG will notify the applicant of its decision. If an application for reinstatement is denied, the excluded individual or entity has 30 days to submit documentary evidence and written argument against the continued exclusion. He or she also may make a request to present written evidence and oral argument to an OIG official. After evaluating the submission, the OIG will send the provider written notice of its final decision. If the OIG confirms its decision to deny reinstatement, the decision is not subject to administrative or judicial review, and the provider must wait at least one year to submit another request for reinstatement (42 C.F.R. § 1001.3004).

WAIVERS

The OIG has the authority to grant a “waiver” of an exclusion under certain limited circumstances as found in 42 C.F.R. § 1001.1801, et seq. The request must come from the administrator of a federal healthcare program who is “directly responsible” for administering that program under certain limited circumstances. It may not be made on behalf of someone excluded for abuse or neglect. If the request is made on behalf of a person who has been the subject of a mandatory exclusion, the administrator must determine that: (1) the individual or entity is the sole source of an essential specialized service in a community, and (2) that the exclusion would impose a hardship to the beneficiaries of that program. Requests made on behalf of persons or entities subject to a permissive exclusion must also be made by a program administrator. However, the waiver may be granted if the “OIG determines that imposition of the exclusion would not be in the public interest” (42 CFR § 10011801(c)). If a waiver is granted, it is applicable only to the program (or programs if made by more than one) for which it has been requested, and if the basis for the waiver ceases to exist, it is rescinded. The decision to grant, deny, or rescind a waiver is not subject to administrative or judicial review (§ 10011801(c)).

CLOSING COMMENTS

The primary goal of this article is to give providers a comprehensive reference guide on the existing legal and regulatory framework of OIG exclusions and the risks and potential consequences of exclusion violations, and to make suggestions on compliance strategies to avoid those risks. However, providers are reminded that there are additional good reasons for having a rigorous and effective exclusion screening program. State Medicaid programs, for example, often have screening requirements that are more rigorous than those of the OIG; and, finally, in light of the fact that almost all exclusions are imposed for reasons related to fraud, abuse, or drugs, providers should also assess the potential risks excluded entities pose to their patients and their organization.  

>> Click here to read part 1 of this article!

ABOUT THE AUTHOR

Provider's Guide to OIG ExclusionPaul Weidenfeld is a former federal healthcare fraud prosecutor and Department of Justice National Health Care Fraud Coordinator. His principle area of practice is healthcare fraud and abuse and the Federal False Claims Act, and he has represented providers and individuals in healthcare matters since leaving government in 2006. He is currently “Of Counsel” to the firm of Liles Parker. Mr. Weidenfeld also has an extensive litigation background that includes numerous trials and appeals and appearances before the United States Supreme Court, the Federal 5tht Circuit Court of Appeals, and the Louisiana Supreme Court. He has received recognition both as a prosecutor and as defense counsel and has been recipient of numerous awards. These include Nightingale’s Outstanding Healthcare Litigators, the Attorney General Award for Fraud Prevention, the Office of Inspector General Cooperative Achievement Award, and the National “Case of the Year” honors by the NHCAA. In 2014, Mr. Weidenfeld cofounded Exclusion Screening, LLC. Exclusion Screening helps providers navigate the difficulties and issues related to the screening for excluded individuals and entities, and along the way he has become one of the foremost experts in the field of IG exclusions and Exclusion-related issues.



REFERENCES AND ENDNOTES

 

[1] The self disclosure protocol was updated on April 17, 2013, and the Special Advisory was updated May 3, 2013.
[2] The Office of Evaluations and Inspections (OIG/OEI) and the Office of Audit (OIG/OA).
[3] The table cited is intended to be a demonstrative sample of settlements. Settlements of exclusion civil money penalty cases are reported and published on the OIG website, https://oig.hhs.gov/fraud/ enforcement/cmp/index.asp.
[4] Cases referenced herein have been reported and published on https://oig.hhs.gov/fraud/enforcement.
[5] Overpayments that are not the result of a regulatory violation can occur if a provider properly screens and an employee is added to the LEIE while employed. This would limit the overpayment and not result in a CMP.
[6] The updated Bulletin was issued, in part, to provide guidance “on the scope and frequency of screening employees and contractors” See 2013 Special Advisory at 1.
[7] CIAs are imposed by the OIG in lieu of their imposing administrative remedies in cases involving FCA investigations. As such, requirements in them are sometimes concrete examples of OIG interpretations and expectations, and therefore they can be useful as “guidance.”
[8] Meaning to take actions sufficient to ensure that the employee does not touch federally reimbursed services. But even if it were possible that a provider could meet this test, the scope of the payment prohibition is so broad that it is unlikely that it would be worth the effort to remove them from the screening list.
[9] See https://downloads.cms.gov/cmsgov/archived-downloads/ SMDL/downloads/SMD061208.pdf
[10] See https://downloads.cms.gov/cmsgov/archived-downloads/ SMDL/downloads/SMD011609.pdf
[11] In addition to meeting its regulatory obligations, a proper exclusion screening program can also provide significant benefits to compliance and risk management programs. See HCCA, Measuring Compliance Program Effectiveness: A Resource Guide (Jan. 2017), available at https://oig.hhs.gov/compliance/compliance-resource-portal/files/ HCCA-OIG-Resource-Guide.pdf.
[12] States, at a minimum, require that providers screen the LEIE and the state list (if there is one). However, they may also require providers to screen additional state lists and/or additional Federal debarment lists.
[13] The author is a cofounder of Exclusion Screening, LLC, a third-party vendor of exclusion screening services.
[14] See OIG’s Provider Self-Disclosure Protocol (April 17, 2013). https:// oig.hhs.gov/compliance/self-disclosure-info/files/Provider-Self- Disclosure-Protocol.pdf.
[15] The result is generally proportionate to the violation because of the loss increases in proportion to the employment of the excluded employee, the amount of salary paid to that person, and the payer mix of the entity. For example, the loss involving an excluded nursing aide that was discovered soon after hire by a provider with a 25% federal payer mix would be minimal compared with that involving an excluded administrator or management employee who worked for a provider with a 75% federal payer mix for a period of months or possibly even years before discovery.

 

 

 

Pennsylvania Doctor Excluded in Connection with Quality of Care


(September 26, 2019): 
Over the past year, both State and Federal law enforcement investigators and prosecutors have gone to considerable lengths to publicize the government’s fight against opioid abuse.  While much of this fight has focused on the manufacturers of prescription opioid products, the improper prescribing practices of physicians and other medical professionals found to be prescribing these drugs “without any legitimate purpose and outside the usual course of professional practice” have been repeatedly highlighted in criminal prosecutions by U.S. Attorney’s Offices around the country.  A recent case against a Philadelphia-area cardiologist provides a classic example of how improper opioid prescribing practices can lead to criminal prosecution, civil penalties AND severe administrative sanctions (in this case, exclusion from participation in Federal health care programs).  The article examines how the cardiologists was identified and steps you should take to reduce your level of risk in this regard.

 I. Background of the Case:

Like many big cities, Philadelphia has a problem with illegal drugs.  Despite the city’s efforts to curb illicit drug use, unintentional drug overdoses have steadily grown since 2010 and have only slightly tapered-off from their all-time high since 2017.[1]

Social Security Act 1128(b)(6)
While the percentage of opioid-related deaths changes from quarter to quarter, it is estimated that approximately 80% of all unintentional drug deaths in Philadelphia are due to opioid misuse and overdose.  In response to the opioid abuse crisis in Philadelphia and other areas of the country, a multi-agency team of Federal and State investigators and prosecutors, known as the Medicare Fraud Strike Force[2] (Philadelphia Strike Force) has been targeting physicians, nurse practitioners and other medical professionals who have been improperly prescribing and / or distributing opioids.  In this particular case, the prescribing practices of this Philadelphia cardiologist (defendant) were identified by the Philadelphia Strike Force as warranting further review.  Upon investigation, the government alleged that from 2016 to 2018, the defendant wrote a number of prescriptions for oxycodone and / or benzodiazepine to patients without a legitimate medical purpose.  

In light of the allegations presented, the U.S. Attorney’s Office pursued both civil and criminal claims against the cardiologist.  It is important to keep in mind that the Department of Justice has long instructed its prosecutors to pursue parallel criminal and civil actions against a defendant, when appropriate.  As Title 9, Section 27 of the Justice Manual[3] provides:

Department policy is that criminal prosecutors and civil trial counsel should timely communicate, coordinate, and cooperate with one another and agency attorneys to the fullest extent appropriate to the case and permissible by law, whenever an alleged offense or violation of federal law gives rise to the potential for criminal, civil, regulatory, and/or agency administrative parallel (simultaneous or successive) proceedings. By working together in this way, the Department can better protect the government’s interests (including deterrence of future misconduct and restoration of program integrity) and secure the full range of the government’s remedies (including incarceration, fines, penalties, damages, restitution to victims, asset seizure, civil and criminal forfeiture, and exclusion and debarment).”  (emphasis added). 

The Justice Manual guidance further notes that:
“Courts have recognized that “[t]here is nothing improper about the government undertaking simultaneous criminal and civil investigations provided that we use those proceedings and associated investigative tools for their proper purposes and in appropriate ways.”  (emphasis added).

II. Criminal Prosecution for Violations of 21 USC §841(a)(1) and (b)(1)(C):

In March 2019, the defendant pleaded guilty to eight felony counts of the unlawful distribution and dispensing of a controlled substance, in violation of 21 USC §841(a)(1) and (b)(1)(C).   The defendant’s sentencing is scheduled to take place later this year.  As a result of the criminal conviction, the defendant may be sentenced to prison for a significant period of time AND assessed criminal fines for his unlawful conduct.

III.  Civil Liability under the False Claims Act, 31 USC §3729:

Notably, it does not appear that the defendant entered into a “global” settlement at the time he decided to plead guilty to the criminal charges discussed above.  As a result, any civil and / or administrative actions that the government might choose to pursue remained active.  On July 1, 2019, the defendant agreed to enter into a False Claims Act settlement with the government and pay $107,584 in penalties and damages to the government.   

IV. Administrative Actions Taken Against the Defendant:

As part of his civil settlement reached with the government, the defendant cardiologist agreed to:
  • Surrender his medical license and Drug Enforcement Administration Certificate of Registration and further agreed not to seek to renew or reinstate either one in the future.
  • Be excluded from participation in Federal Health programs.
As HHS-OIG’s records reflects, the defendant was excluded from participation in Federal health care programs on July 18, 2019.  The basis for exclusion cited by the government is Section 1128(b)(6) of the Social Security Act – Quality of Care.

As you will recall, under Section 1128 of the Social Security Act, if an individual or entity is convicted of certain crimes, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) is required by law to exclude the individual or entity from participation in Federal health care programs.  These types of actions are referred to as “Mandatory Exclusions.”  The bases for imposing a mandatory exclusion are set out in Section 1128(a)(1) through Section 1128(c)(3)(G)(ii).  In contrast to mandatory exclusion actions, there are also a number of “Permissive Exclusion” authorities that may be used (at the agency’s discretion) by HHS-OIG to bar an individual or entity from participating in Federal health benefit programs.  The permissive exclusion authorities that may be exercised by HHS-OIG are covered in the Social Security Act from Section 1128(b)(1)(A) through 1128(b)(16).  HSS-OIG may also exercise its permissive exclusion authority under Social Security Section 1156, if a provider fails to meet its obligations to provide medically necessary services that meet the professional recognized standards of care.
In this particular case, HHS-OIG chose to exercise its permissive exclusion authority under Section 1128(b)(6) of the Social Security Act – Quality of CareThis particular basis for excluding an individual or entity can be assessed if a defendant or target is alleged to have submitted:
“Claims for excessive charges, unnecessary services or services which fail to meet professionally recognized standards of health care, or failure of an HMO to furnish medically necessary services.”
Under this statutory provision, an individual or entity can be excluded for a minimum period of one year.  In light of the allegations presented, the defendant cardiologist was excluded from participation by HHS-OIG for a total of seven years.[4]

V. Impact of Medicare Exclusion on the Defendant’s Career:

As the case synopsis above reflects, Federal law enforcement prosecuted the defendant in this case to the full extent of their abilities.  In addition to facing incarceration, the defendant was also assessed penalties and damages of more than $107,000 under the False Claims Act.  While the criminal and civil actions taken against the defendant are quite serious, the cardiologist’s problems are further magnified by the fact that he has also been excluded from participation in Federal health care programs.  At the end of the day, it is quite conceivable that the U.S. Sentencing Guidelines, the defendant’s criminal sentence will be relatively brief.  Depending upon the terms of his civil / administrative settlement, he may be free to seek licensure in another state upon his release from jail. 

VI. Final Thoughts:

Even assuming that the defendant regains licensure in another state, the administrative exclusion action taken against him will effectively bar him from enrolling in Federal health care benefit programs for the entire period that he remains excluded.  While excluded, he will not be eligible to work for any provider or supplier who participates in one or more Federal health care plans.  Should a health care provider or supplier choose to employ the defendant (an excluded party), each of the claims submitted to Medicare, Medicaid and other government plans may be subject to significant civil monetary penalties. 

How can you protect your practice?  Consistent with your obligations under the law, it is imperative that you screen your employees, agents, contractors and vendors against all of the 43 exclusion databases currently in operation.  Unfortunately, it is practically impossible for a medical practice or other entity to screen one or more of its employees against all 43 databases.  Luckily, the folks at Exclusion Screening can take this time-consuming (and often frustrating) task off of your shoulders.  Give us a call at 1 (800) 294-0952 for a complimentary discussion of your screening needs and a quote.


[2] The government’s Medicare Fraud Strike Force is primarily composed of Federal agents and investigators of the Department of Health and Human Services, Office of Inspector General (HHS-OIG) and the Federal Bureau of Investigation (FBI), along with Federal prosecutors working for U.S. Attorneys Offices around the country.  First established in March 2007, the Strike Force has been instrumental in investigating and prosecuting cases of health care fraud, waste and abuse. 
[4] “Pennsylvania physician Agrees to Voluntary Exclusion” https://oig.hhs.gov/fraud/enforcement/cmp/cmp-ae.asp

A Provider’s Guide to OIG Exclusions

A Provider’s Guide to OIG Exclusions

Federal Exclusion Regulations and Enforcement Authorities, and How Providers Can Avoid Risk with Proper Exclusion Screening–Part 1

Paul S. Weidenfeld, JD

This article was originally written by Paul Weidenfeld and published by GreenBranch Publishing.  This article is Part I from a 2-Part article originally published by GreenBranch Publishing on their website.

OIG ExclusionOffice of Inspector General (OIG) exclusions[1] are one of the most powerful weapons available to the law enforcement in its efforts to fight healthcare fraud. Individuals and entities subject to an OIG exclusion are barred from participation in all Federal healthcare benefit programs, resulting in a payment prohibition on all items and services they provide, whether directly or indirectly. Additionally, providers that employ or contract with excluded individuals or entities risk the imposition of civil money penalties, overpayment liability, and even potential exposure under the False Claims Act. However, even though OIG exclusions are one of law enforcement’s oldest tools, many providers often fail to appreciate their compliance obligations and the risks associated with employing or contracting with excluded individuals or entities. Indeed, many providers take only minimal efforts to screen their employees and contractors to ensure compliance—and some make no effort at all. This article seeks to educate providers on the existing legal and regulatory framework, the risks and potential consequences of a failure to comply with those laws and regulations, and how best to comply and avoid those risks.[2]

LEGISLATIVE BACKGROUND

Congress initially authorized the use of exclusions as an enforcement tool in the battle against healthcare fraud over 40 years ago with the passage of the Medicare-Medicaid Anti-Fraud and Abuse Amendments of 1977. The bill granted the Department of Health, Education and Welfare, which later became the Department of Health and Human Services (HHS), the authority to exclude physicians and others convicted of crimes related to Medicare and Medicaid from participating in those programs.[3] In 1981, the Civil Money Penalties Law (Public Law 97-35 [codified at section 1128A of the SSA]) extended the authority to impose penalties to providers that submitted claims for items or services that had been furnished by an excluded entity, and the Secretary of HHS delegated his exclusion authority to its Office of Inspector General (OIG) in 1988 (53 Fed. Reg. 12,993 (April 20, 1988)). The current framework of mandatory and permissive exclusions was then established by the Medicare and Medicaid Patient and Program Protection Act of 1987.

In 1995, Attorney General Janet Reno declared healthcare fraud to be one of the top priorities of the Department of Justice, second only to violent crime.[4] Shortly thereafter, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L.105-33, 111 Stat.1936, enacted August 21, 1996) extended the OIG’s exclusion authority to all Federal healthcare programs.[5] The Balanced Budget Act of 1997 (BBA) (Pub.L.105-33, 111 Stal. 251. enacted August 5, 1997) expanded the OIG’s Civil Money Penalty (CMP) authority to apply to providers that employed or contracted with entities subject to an OIG exclusion. Prior to the passage of the BBA, the OIG could impose penalties only on excluded entities or persons who submitted claims on their behalf. The OIG’s permissive exclusion authorities were expanded in both the Medicare Modernization Act of 2003 (MMA) (Public Law No: 108-173, enacted December 8, 2003) and the 2010 Affordable Care Act (ACA). Initially passed as the “Patient Protection and Affordable Care Act,” Pub. L. No 111-148 (2010), and shortly thereafter amended by the “Health Care and Education Reconciliation Act of 2010,” Pub. L. No. 111-152 (2010), these two pieces of legislation are collectively referred to as the “Affordable Care Act” (ACA).

WHAT IS AN OIG EXCLUSION? WHAT IS ITS IMPACT?

OIG exclusions are final administrative actions that bar individuals and entities from any and all participation in Medicare, Medicaid, and all other federal healthcare programs.[6] They are imposed “to protect beneficiaries…stem fraud and abuse…ensure that federal health care programs are protected…and help make sure excluded individuals are not involved in any way in the care of federal program beneficiaries.”[7] Excluded entities are deemed, as a matter of fact and law, to pose unacceptable risks to federal healthcare programs and to the patients they serve.

The effect of an OIG Exclusion is extremely broad. Federal healthcare programs, broadly defined to include “any plan or program that provides health benefits either directly or indirectly, will not pay for “any items or services” that are “furnished” by an excluded individual or entity, or at the medical direction or on the prescription of an excluded person. (see 42 C.F.R. 1001.1901(b), 42 C.F.R. § 1001.10). “Items or services” include any item, device, drug, biological, supply, or service—including management or administrative services; and they are “furnished” if provided or supplied, either directly or indirectly, by an individual or entity; and an “indirect claim” is “furnished” even if a non-excluded provider submits the claim if an excluded entity actually provided the service in the first place.[8]

The “payment prohibition” is a complete payment ban applicable to “all methods of Federal program reimbursement” regardless of whether it is from an itemized claim, cost report, capitated payment, or other bundled payment. It extends beyond direct patient care and includes, for example, services performed by excluded individuals who work for or under an arrangement with a hospital, nursing home, home health agency, or managed care entity where they are separately billed or part of a bundled payment. (See 2013 Special Advisory, at pages 6 and 7.) The following are examples of activities identified by the OIG in the Special Advisory as potentially problematic and susceptible to the imposition of civil money penalties if not properly screened for exclusions:
  • Management, administrative or any leadership roles;
  • Surgical support such as the preparation of a surgical tray that indirectly assists in care;
  • Claims processing and information technology;
  • Providing transportation services with excluded ambulance drivers or by employing excluded ambulance company dispatchers;
  • Selling, delivering or refilling orders for medical devices or equipment (whether reimbursed directly or indirectly);
  • Review of treatment plans, and other support services, whether billed separately or as part of a bundled payment.
Even unpaid volunteers can trigger overpayment and CMP liability if the items or services they furnish are not “wholly unrelated to Federal Health Care Programs” and the provider “does not ensure that appropriate exclusion screening was performed!” (Emphasis added, 2013 OIG Special Advisory, at 11-12, 16; see also Advisory Opinion No. 18-01.)

The payment prohibition also extends to providers that furnish items or services on the basis of orders or prescriptions they receive from others. Thus, in addition to screening their own employees, vendors, and contractors, providers such as laboratories, imaging centers, and pharmacies “should ensure, at the point of service, that the ordering or prescribing physician is not excluded. A failure to do so on their part would violate the payment prohibition and could result in both overpayments and CMPs. (2013 Advisory, page 8.)

TYPES OF OIG EXCLUSIONS

There are two types of OIG Exclusions – Mandatory and Permissive. Mandatory Exclusions are identified in Sections 1128(a)(1) – 1128(a)(4) of the Social Security Act (SSA), (42 U.S.C. §1320a-7(a)(1)-(4)) and they are imposed as a result of convictions for program fraud, patient abuse and certain drug offenses.  Permissive exclusions, on the other hand, are discretionary and can be imposed for broad range of conduct. These are identified in §1128(b)(1)–§1128(b)(16) and §1156 of the Act. [9] 

Figure 1. All Exclusions 2013-2017

The following figures provide a general breakdown of OIG Exclusions over the last five years. Figure 1A illustrates that permissive exclusions based on licensing disciplinary actions and mandatory exclusions based on federal health care fraud convictions accounted for over 75% of all exclusions during this period (41% and 35% respectively). The first chart also illustrates that mandatory exclusions accounted for 55% of all exclusions.

Figure 2 breaks down exclusions by “specialty” as labeled by the OIG in the LEIE postings.[10] It shows that nurses, nurse aides, personal care providers, home health care aides and physicians account for almost two-thirds of all exclusions over the last five years.  Taken together, these two charts demonstrate the OIG’s dual focus on patient safety and program integrity.

Mandatory Exclusions

Figure 2. All Exclusions by Specialty

Sections 1128(a)1-(a4) of the Social Security Act identify the four legal basis which warrant the imposition of a mandatory exclusion by the Office of Inspector General. They are:

  • 1128(a)(1): Conviction related to the delivery of an item or services to a Federal or State Health Care Program;
  • 1128(a)(2): Conviction under State or Federal law relating to neglect or abuse of patients in connection with the delivery of a health care item or service;
  • 1128(a)(3): Felony conviction relating to health care fraud program (other than Medicare or Medicaid); and,
  • 1128(a)(4): Felony conviction relating to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance.

It is important to note that though a mandatory exclusion under sections 1128(a)(1) and (a)(2) must be based on a “conviction,” the term is extremely broadly defined. “Nolo contendere” pleas, for example, qualify as convictions under this section; even dispositions under first offender programs and deferred adjudications – programs where no finding of guilt is ever entered – satisfy the conviction requirement for purposes of the Act.  In addition, Section 1128 is satisfied by any “State, Federal or Local Court.” (See §§ 1128(i)(1)- (i)(4) of the Social Security Act.) Thus, it has been held that a deferred adjudication agreement in a local court for misdemeanor theft is a sufficient basis for the imposition of a mandatory exclusion under (a)(1) because it was related to Medicaid services. (Department of Health and Human Service, Departmental Appeals Board Civil Remedies Division, Okwilagwe v. The Office of Inspector General, Docket No. C-13-322, Decision No. CR2920, September 6, 2013.) The same standards would apply to exclusions under (a)(2).

Mandatory exclusions be must be imposed for at least five years, however they are often imposed for much longer periods if warranted by the underlying facts and circumstances. Once a mandatory exclusion is imposed, the person must wait at least five years before applying for reinstatement if this is their first exclusion, but ten years must pass before reinstatement may be sought after a second mandatory exclusion, and a third mandatory exclusion is permanent. If the OIG seeks to impose a mandatory exclusion, the only viable defense that can be raised is the length of the exclusion is subject to challenge. (42 C.F.R. 402.214.)

Finally, it is worth noting that the “balance” of mandatory to permissive exclusions appears to be changing. The current composition of all exclusions on the List of Excluded Individuals and Entities (LEIE) is 47% mandatory and 53% permissive, but Figure 1B shows us that during the period 2013 to 2017 the percentages essentially switched as mandatory exclusions increased from 47% to 55%. And in 2017 the mandatory exclusions increased to almost 63% of all exclusions.[11]  Althought these data are relatively new and there is no ready explanation, it is a trend worth watching.

Permissive Exclusions

The OIG’s permissive exclusion authority has been expanded a number of times over the years, and the imposition of permissive OIG exclusions includes convictions for obstructing heatlhcare investigatiosn adn/or audits, improper certification for items or services, and making false statements or misrepresentations in applicatiosn to participate in Medicare.[12] The following is a list of the permissive exclusions as found on the OIG website:[13]

Table 1. Permissive Exclusions

Figure 3. Compliance Risk Spectrum.

Unlike its mandatory exclusion authority which is virtually automatic when specific convictions occur, the OIG has the discretion to impose permissive exclusions over a wide range of conduct (or misconduct). OIG guidance on the implementation of its permissive exclusion authority, begins with a presumption favoring exclusion under certain circumstances. The guidance outlines a “compliance risk spectrum” that is based on the risks posed to patients and to federal health care programs. The factors to be considered include a company’s underlying conduct during the investigation, in addition to current and historical compliance efforts.[14]  The OIG also issued specific guidance with respect to the imposition of permissive exclusions based on an excluded individual’s ongoing role or interest in a company.[15]

Although the OIG is authorized to impose permissive exclusions over a wide range of conduct, figure 4 shows that the agency actually invokes its permissive exclusion authority over a narrow range of persons and limited circumstances. For example, Figure 4A shows that nurse and nurse aides alone account for approximately 70% of all permissive exclusions, with “other licensed professionals” (mostly therapists, mid-level providers and counselors) and physicians accounting for 16% and 9% respectively.  As nurses and nurse aides are the persons in the best positions to impact both patient care and claims arising from that care, it is not surprising that they comprise a significant percentage of the exclusions. However, it is somewhat surprising that business owners only account for 3% of all permissive exclusions.   

Figure 4. Entities Subject to Permissive Exclusions 2013-2017 and Percentage Breakdown

 

Figure 5. All Permissive Exclusions by Basis (2013-2017)

As seen in Chart 5, despite the many permissive exclusion options available to the OIG, the vast majority of permissive exclusions it has imposed over the last five years (a surprisingly high 90%) were based on final disciplinary actions such as license suspensions and revocations that had been taken by a State licensing board. The only other measurable bases were health care fraud misdemeanors, State exclusions, fraud or kickbacks, and defaults on student loans – though none of which accounted for more than 3% of the permissive exclusions imposed.




Process, Finality and Appeal Rights for OIG Exclusions

The process of imposing and appealing an exclusion depends upon the exclusion the OIG seeks to impose as is governed by 42 C.F.R. §§ 1001.2001- 1001.2007.  When the OIG seeks to impose a mandatory exclusion, it may initiate the process by sending the party a Notice of Intent to Exclude, which identifies the basis for the proposed exclusion, describes the potential effect of an exclusion, and gives the individual or entity 30 days to respond in writing with relevant information or evidence.  At this stage in a mandatory exclusion, there is no provision for a hearing.  Indeed, the OIG can skip the “Notice of Intent” when seeking a mandatory exclusion and begin the process with a “Notice of Exclusion.”  This must include the basis and length of the exclusion, the earliest reinstatement date, the requirements for reinstatement, and the excluded party’s appeal rights.  When the OIG seeks a permissive exclusion, in most instances it begins the process with a “Notice of Intent to Exclude.” However, if the OIG seeks to exclude based on something other than an underlying final determination (such as a license revocation or State exclusion action), the process may include a “Notice of Proposal to Exclude.”

Exclusions may be appealed first to an Administrative Law Judge (ALJ), then to the Departmental Appeals Board (DAB), and then to a United States District Court. However, appeals of exclusions are limited to two issues: (1) whether the OIG had a “basis for the imposition of the sanction,” and (2) whether the length of the exclusion is unreasonable. 42 C.F.R. 402.214. In addition, an ALJ considering these issues is prohibited from reviewing the “exercise of discretion” by the OIG, 42 C.F.R. §1005.4(c)(7), and if the sanction is based on a “prior determination,” the underlying basis may not be attacked if a “final decision was made.” § 1001.2007(d).  As a result, most exclusion appeals, particularly those of mandatory exclusions, are focused on the length of the exclusion.

Mandatory exclusions are final 20 after the Notice of Exclusion. They are not stayed pending the outcome of the appeal upon finality. The OIG posts the exclusion on the LEIE, and it sends notices of the exclusion to various State and Federal interests including, but not limited to, State licensing boards, State health programs, medical societies, Medicaid fraud control units, and the National Practitioner Data Bank. 

Enforcement Tools for Exclusion Violations

“Exclusion Violations” are actions taken by an individual or entity in contravention of the “payment prohibition” as defined in 42 C.F.R. § 1001.1901, and the authority to impose CMPs and assessments is delegated by the Secretary to the OIG pursuant to 42 CFR § 1003.150.  The specific exclusion violations for which the OIG has the authority to impose civil money penalties and assessments are presented in Table 2.

Table 2. Civil Monetary Penalties and Assessments

Most of the exclusion cases pursued by the OIG have been for violations of § 1003.200(b)(4) —employing or contracting with an individual or entity. Recently, however, the OIG has been actively investigating and pursuing cases involving the ordering and prescribing of medicine from excluded persons.  42 C.F.R. § 1003.200(b)(6). Investigations involving the direct submission of a large number of claims by an excluded person (such as an excluded physician continuing to practice medicine and submit claims in violation of § 1003.200(a)(3)), or the retention of ownership or control through fraudulent representations in violation of § 1003.200(b)(3)) are fewer in number, and those that have been reported have typically resulted in criminal and/or false claims act resolutions. To date, there have been few, if any, enforcement actions involving MCOs, Medicare Advantage (MA) or Part D contracting organizations that have been reported.

Civil Money Penalties for Exclusion Violations

CMPs are “remedial measures designed to protect the Federal health care programs from any person whose continued participation in the programs constitutes a risk to the programs and their beneficiaries.”[16] designed to protect program integrity and patient safety. They are the favored weapon of the OIG in its enforcement of exclusion violations. As stated in the 2016 final rule amending CMP authorities and incorporating new ones:

“The CMP authorities in this part, as a general matter, aim to redress fraud on the Federal health care programs by recovering funds, protecting the programs and beneficiaries from untrustworthy providers and suppliers, and deterring improper conduct by others. Accordingly, it is highly relevant if the conduct put beneficiaries at risk of patient harm.”[17]

Tabel 3 identifies the OIG’s CMP authority for each exclusion violation.[18]  As can be seen, the OIG may impose a penalty of up to $10,000 for each individual violation of § 1003.200(a)(3) and § 1003.200(b)(6); up to $10,000 for each day § 1003.210(b)(3) is violated; and up to $10,000 for each item or service provided, furnished, ordered, or prescribed in violation of § 1003.200(b)(4). MCOs, MA, and Part D contracting organizations that employ or contract with excluded persons or entities face a penalty of $25,000 for each offense. [19]

Table 3. CMP Authority For Each Exclusion Violation

Assessment Authority of the OIG for Exclusion Violations

In addition to its authority to impose CMPs, the OIG is also authorized to impose assessments for OIG Exclusion violations.  Assessments differ from CMPs in that they are not considered to be sanctions; instead, they may be imposed “in lieu of damages sustained by the Department or the State agency because of the violation.” 42 C.F.R. § 1003.130. [20]  That is, assessments act as a proxy for damages presumed to have been sustained by either the Federal or State agency as a consequence of the violation, and the OIG is specifically authorized to impose them in exclusion violations in 42 C.F.R. § 1003.210 and § 1003.410. Section 1129 of the Social Security Act [42 U.S.C. § 1320a–8(a)(1)].  Since assessments are considered to be a form of restitution and not a penalty or sanction, the OIG theoretically could impose both a CMP and an assessment for an exclusion violation. Table 4 Shows the assessment amounts the OIG is authorized to impose for exclusion violations.

Table 4. Assessment Amounts Authorized by the OIG

The assessment provisions for employing or contracting with excluded individuals were recently amended in an effort to recognize the difference in effect between exclusions involving direct billers (such as a doctor) and those involving persons that provide support services not directly billed (such as an aide).[21] The amended assessment regulations permit an assessment to be as much as three times the amount of each service billed for employing or contracting with a person that provides directly billable services,  whereas the assessment for persons that provide a “non-separately-billable” service is limited to three times the amount of the costs associated with that individual.  As will be discussed later, this is consistent with the methodology of calculating the federal “loss” in self-disclosures involving exclusion violations.

FACTORS IN IMPOSING PENTALTIES AND ASSESSMENTS

When considering the imposition of penalties and assessments, the OIG considers the nature and circumstances of the violation, the degree of culpability of the individual being assessed, the history of prior offenses, other wrongful conduct (if any) and any other matters the OIG deems relevant to its determination. 42 C.F.R. § 1004.140(a). Relevant mitigating and aggravating factors contained in the regulation and discussed in subsequent OIG guidance include the following:[22]

Mitigating Factors:

  • If the length of time was short and the amount claimed was less than $5,000.

Aggravating circumstances:

  • There were several violations, or a pattern, over a lengthy period of time;
  • The ownership, control, or responsibility implicated §1003.200(b)(3);
  • The amount claimed or requested for such items was $50,000 or more;
  • The violation caused or could have caused, adverse patient consequences.

Appeal Rights for Civil Money Penalties and Assessments

The appeal rights of parties with respect to CMPs and assessments are found in 42 C.F.R. § 1005 et seq.  Parties have the right to request a hearing before an ALJ to challenge the imposition of penalties and assessments if they make a written request within 60 days of receiving notice of the sanction. The process allows for representation by counsel, discovery rights, the right to present and cross examine witnesses, a hearing, and the right to present oral and written arguments to the ALJ.  The ALJ has full authority over the pre-hearing process and the hearing itself.  However, the ALJ does not have the authority to compel negotiations, enjoin the Secretary in any way, invalidate existing regulations, or refuse to follow them.  The ALJ is also not permitted to review the exercise of discretion by the OIG to impose a CMP or assessment. At the conclusion of the hearing, the ALJ issues an “initial decision” which includes findings of fact and conclusions of law in which he may increase or reduce penalties and assessments. 

An “Initial Decision” can be appealed to the DAB; a timely appeal stays the imposition of a CMP. The DAB has broad authority in the manner in which it handles the appeal.  It can decline to review the case; increase, reduce, or remand a penalty or assessment determined by the ALJ; and remand the matter to the ALJ for consideration of additional evidence.  The decision of the DAB is final 60 days from issuance unless it involves a remand, and the parties have the right to appeal the DAB ruling to federal district court. A stay of the imposition of a CMP may be requested during the federal appeal process. However, the request goes to the ALJ that imposed the penalty in the first instance, and the ALJ is not authorized to grant the stay unless a bond or other security is posted.

Potential Overpayment and False Claims Act Liability for Exclusion Violations

Providers have the burden of ensuring that they comply with exclusion-related regulations and that they do not employ or contract with an excluded individual or entity. Those that fail in this obligation are at risk for overpayment liability regardless of whether they have actual knowledge of the person’s status at the time of their transaction. As the OIG states: “If a hospital contracts with a staffing agency for temporary or per diem nurses, the hospital will be subject to overpayment liability … if the nurse furnishes items or services reimbursed by a federal health care program. 2013 Special Advisory, at 15. 

Exclusion violations can also give rise to potential False Claims Act (FCA) liability under the Fraud Enforcement Recovery Act of 2009 (FERA) and the Affordable Care Act of 2010 (ACA).[23]  FERA expands the scope of “reverse false claims” liability under the FCA by making the retention of an “obligation” to the government a false claim, and the ACA specifically states that retained overpayments are legal “obligations” under FERA. Thus, since providers “know” they have a legal obligation to ensure compliance with exclusion regulations and that overpayments result from exclusion violations, any failure of compliance that results in an overpayment may be viewed as the result of conduct that constituted a “reckless disregard” or a “deliberate ignorance” of the rules – and that therefore violated the FCA.

>> Click here to read part 2 of this article!

ABOUT THE AUTHOR

Provider's Guide to OIG ExclusionsPaul Weidenfeld is a former federal healthcare fraud prosecutor and Department of Justice National Health Care Fraud Coordinator. His principle area of practice is healthcare fraud and abuse and the Federal False Claims Act, and he has represented providers and individuals in healthcare matters since leaving government in 2006. He is currently “Of Counsel” to the firm of Liles Parker. Mr. Weidenfeld also has an extensive litigation background that includes numerous trials and appeals and appearances before the United States Supreme Court, the Federal 5tht Circuit Court of Appeals, and the Louisiana Supreme Court. He has received recognition both as a prosecutor and as defense counsel and has been recipient of numerous awards. These include Nightingale’s Outstanding Healthcare Litigators, the Attorney General Award for Fraud Prevention, the Office of Inspector General Cooperative Achievement Award, and the National “Case of the Year” honors by the NHCAA. In 2014, Mr. Weidenfeld cofounded Exclusion Screening, LLC. Exclusion Screening helps providers navigate the difficulties and issues related to the screening for excluded individual and entities, and along the way he has become one of the foremost experts in the field of IG exclusions and Exclusion-related issues.


[1]
“OIG” in this paper refers to “Office of Inspector General, Department of Health and Human Services” unless otherwise stated.  The term “OIG Exclusion” is used as shorthand for an administrative action taken by the OIG barring an individual or entity from participating in Federal health care programs pursuant to §1128(a)(1)-(4), (b)(1)-(b)(16) or §1156 of the Social Security Act (SSA).
[2] This article focuses on exclusions from a regulatory and enforcement perspective, but exclusions also play a critical role in compliance and risk management programs. See, e.g., HCCA, Measuring Compliance Program Effectiveness: A Resource Guide (Jan. 2017), available at ttps://oig.hhs.gov/compliance/compliance-resource-portal/files/HCCA-OIG-Resource-Guide.pdf. (guidance reconfigures the traditional “Seven Elements of an Effective Compliance Program” and makes the “Screening and Evaluation of Employees, Physicians, Vendors and other Agents” an element unto itself – or the new “Seventh Element of Compliance”).
[3] The Medicare-Medicaid Anti-Fraud and Abuse Amendments of 1977, Public Law 95142.  In 1979, the Department of Health Education and Welfare was renamed the Department of Health and Human Services (HHS).
[4]See e.g. Crackdown on Health Care Fraud, https://www.nytimes.com/1995/12/22/us/in-crackdown-on-health-care-fraud-us-focuses-on-training-hospitals-and-clinics.html.
[5] In addition to establishing the principle of insurance portability, HIPAA contained several provisions related to health care fraud enforcement, including containing legislation that significantly increased the ability of law enforcement agencies to obtain and share information and establishing the Health Care Fraud and Abuse Fund (HCFAC) as a permanent funding source specifically designated for health care fraud enforcement.
[6] The effect of an OIG Exclusion is addressed in the Special Advisory Bulletin on the Effects of Exclusion from Federal Health Care Programs,” issued September 2, 1999, and in the “Updated Special Advisory Bulletin on the Effect of Exclusions from Participation in Federal Health Care Programs,” issued May 8, 2013.  Hereinafter, the initial advisory will be referred to as the “1999 Special Advisory” and the update will be referred to as the “Updated Special Advisory” or the “2013 Special Advisory.”  The 1999 Special Advisory can be found at: https://oig.hhs.gov/fraud/docs/alertsandbulletins/effected.htm; the 2013 Updated Special Advisory can be found at https://oig.hhs.gov/exclusions/files/sab-05092013.pdf. 
[7] Inspector General June Gibbs Brown, in the press release for the 1999 Special Advisory.   
[8] See 42 C.F.R. § 1001.10. Definitional changes were made to direct and indirect claims pursuant to rulemaking authority granted to the OIG in the MMA and the ACA; See also, OIG Advisory Opinion No. 18-01 at 5 (Feb. 20, 2018) available at https://oig.hhs.gov/fraud/docs/advisoryopinions/2018/AdvOpn18-01.pdf.
[9] The Data in the figures in this section come from the exclusion data reportered in the List of Excluded Individuals/Entities (LEIE) by calendar year.
[10] The data in the charts in this section comes from exclusion data reported in the List of Excluded Individuals/Entities (LEIE).
[11] These calculatiosn are based on the composition of the LEIE through December 31, 2017.
[12] See, §§ 1128(c)(3)(G)(i) and (G)ii of the SSA. See also 82 Fed. Reg. 4100.
[13] See https://oig.hhs.gov
[14] See Criteria for implementing section 1128(b)(7) exclusion authority (April 18, 2016) available at https://oig.hhs.gov/exclusions/files/1128b7exclusion-criteria.pdf. The OIG breaks these down into “high risk factors,” “low risk factors,” and factors that have “no effect.” High risk factors include the impact on beneficiaries cooperation, and whether an adverse licensing action occurred. “Lower risk” factors include acceptance of responsibility and self-disclosure. Factors that are “expected,” and thsu have “no effect”, are coopearation in the investigation and having a compliance plan with the seven elements of compliance.
[15] See Guidance for the Implentation of its Permissive Exclusion Authority Under Sectino 1128(b)(15) at 1, available at https://oig.hhs.gov/fraud/exclusions/files/permissive_excl_under_1128b15_10192010.pdf. The guidance was issued because 1128(b)(15) provides for exclusion based on whether the individual in question is either an owner or an officer or a managing employee and the analysis is different for each.
[16] Criteria for implementing section 1128(b)(7) exlcusion authority (April 18, 2016) avialable at https://oig.hhs.gov/exclusions/files/1128b7exclusion-criteria.pdf.See also 81 Fed. Reg. 88, 334 (Dec. 7, 2016): “In 1981, Congress enacted the CMPL, section 1128A of the Act (42 U.S.C. §1320a-7a), as one of several administrative remedies to combat fraud and abuse in Medicare and medicaid”
[17]Id. 81 Fed. Reg. at 88.
[18] This is a listing of the CMP authorities related to exclusion violations. A complete listing of the OIGs CMP authorities can be found on the OIG’s website, or at 42 C.F.R. § 1003.210. 
[19] The OIG may also impose a penalty or, when applicable, an assessment, against a Medicare Advantage or Part D contracting organization with a contract under section 1857 or 1860D-12 of the SSA if any of its employees, agents, or contracting providers violate § 1003.400(a) – (d). 
[20] The penalty amounts for CMPs and assessments are updated annually and are published at 45 C.F.R. § 102.
[21] A discussion of the change is found in 81 Fed. Reg. 88, 334 (Dec. 7, 2016). 
[22] See 42 CFR § 1004.140(c); see also Criteria for implementing section 1128(b)(7) exclusion authority (April 18, 2016), available at https://oig.hhs.gov/exclusions/files/1128b7exclusion-criteria.pdf..
[23]See § 3729(a)(1) of the Fraud Enforcement Recovery Act of 2009 and § 6401of the Affordable Care Act (2010).

Current States With Separate Exclusion Databases



I. Medicaid Exclusion

Exclusion Screening, LLC conducts monthly checks of our clients’ employees, contractors, and vendors against the OIG-LEIE, GSA-SAM, and all available State Exclusion Lists. Most providers understand that they have an obligation to check their employees, contractors, and vendors against the OIG-LEIE prior to hiring and monthly thereafter. Fewer providers are aware of their obligation to screen their individual state exclusion list, if their state maintains such a list.

CMS directed state Medicaid Directors to remind all providers that they have an obligation to search their state list whenever they search the LEIE.[1] In addition, many states require providers when they enroll or re-enroll in the Medicaid program to certify that no employee or contractor is excluded from participation in any state. This requirement echoes the Affordable Care Act (ACA) Section 6501, which states that if a provider is excluded in one state, he or she is excluded in all fifty states.[2]

II.  SAFERTM 

Exclusion Screening, LLC’s proprietary database, SAFER (State and Federal Exclusion Registry), imports the most recent exclusion data from each state list constantly. We are also in regular contact with state Medicaid and Program Integrity Offices about their lists.

III. State Exclusion Lists

The states that currently maintain a separate excluded provider list are the following ones below, click on a state to learn more about its screening requirements: 

AlabamaIdahoMichiganNorth Carolina
AlaskaIllinoisMinnesotaNorth Dakota
ArizonaIndianaMississippiOhio
ArkansasIowaMissouriPennsylvania
CaliforniaKansasMontanaSouth Carolina
ColoradoKentuckyNebraskaTennessee
ConnecticutLouisianaNevadaTexas
FloridaMaineNew HampshireWashington
GeorgiaMarylandNew JerseyWashington DC
HawaiiMassachusettsNew YorkWest VirginiaWyoming

IV.  Some States Require Screening Extraneous Lists

In addition to these states’ excluded provider lists, many states also require providers to check other various Medicaid Exclusion databases. In Ohio, for example, providers must search the Ohio Department of Developmental Disabilities Abuser Registry, the Ohio Auditor of State – Finding for Recovery Database, Ohio Department of Developmental Disabilities Abuser Registry, Social Security Administration’s Death Master File, The National Plan and Provider Enumeration System, in addition to the LEIE, SAM, and Ohio Exclusion List.[3] New Jersey providers must check the LEIE, New Jersey Division of Consumer Affairs licensure databases, New Jersey Department of Health and Senior Services licensure database, and the certified nurse aide and personal care assistant registry on a monthly basis.[4] 

For additional information visit “OIG Exclusion and State Exclusion Lists: Which Exclusion Lists Need to Be Screened? What Is the Difference Between Them?”
V.  A Simple and Affordable Solution

Without a doubt, state and federal exclusion screening requirements are incredibly burdensome for most providers. If screening your employees against each federal and state list that your state requires is not cost effective for your office to do in-house, contact Exclusion Screening, LLC today at 1-800-294-0952 or fill out our online service form. We would be happy to discuss your specific state obligations, provide a cost assessment, and help you create your employee and vendor list.

Medicaid oig Exclusion

Ashley Hudson, Associate Attorney at Liles Parker, LLP and former Chief Operating Officer for Exclusion Screening, LLC, is the author of this article.


[1] See Letter from Centers for Medicare and Medicaid Services (CMS) to State Medicaid Directors 5 (Jan. 16, 2009).

[2] See 42 U.S.C. § 1396a(a)(39) (2012), available at http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf (codifying the termination requirements of ACA § 6501); see also Letter from Centers for Medicare and Medicaid Services (CMS), CPI-CMS Informational Bulletin, Affordable Care Act Program Integrity Provisions – Guidance to States — Section 6501 – Termination of Provider Participation under Medicaid if Terminated under Medicare or other State Plan (Jan. 20, 2012), available at http://downloads.cms.gov/cmsgov/archived-downloads/CMCSBulletins/downloads/6501-Term.pdf.

[3] See Ohio Admin. Code § 5160-1-17.8(c)(ii); Ohio Medicaid Provider Exclusion and Suspension List, Ohio Dep’t of Medicaid, http://medicaid.ohio.gov/PROVIDERS/EnrollmentandSupport/ProviderExclusionandSuspensionList.aspx (last accessed Jan. 22, 2015).

[4] Newsletter to All Providers, from the New Jersey Dep’t of Human Servs., et al., Excluded, Unlicensed or Uncertified Individuals or Entities (Oct. 2010).

What to Know About the New CMS Preclusion List

By: Cason Liles

New CMS Preclusion List(February 12, 2019) Beginning April 1, 2019, CMS’s new Preclusion List will go into effect subsequently barring many healthcare professionals from receiving payment for Medicare Advantage (MA) items and services or Part D drugs furnished or prescribed to Medicare beneficiaries. But what is the Preclusion List? Who is on it? Why was created? Don’t worry, we’re going to break down everything you need to know about this new CMS action and how it can affect your organization.

 I. What is the Preclusion List?  

The Preclusion List is a list generated by CMS that contains the names of prescribers, individuals, and or entities that are unable to receive payment for Medicare Advantage (MA) items and service and or Part D drugs prescribed or provided to Medicare beneficiaries.

 II. How Does Someone End up on The Preclusion List?  

CMS has given two ways for which someone can end up on the Preclusion List. The first one way is if you:

“Are currently revoked from Medicare, are under an active reenrollment bar, and CMS has determined that the underlying conduct that led to the revocation is detrimental to the best interests of the Medicare program”

 However, even if you are not revoked from Medicare, you still may find yourself on the Preclusion List. CMS is also precluding anyone that has:

“… Engaged in behavior for which CMS could have revoked the prescriber, individual or entity to the extent applicable if they had been enrolled in Medicare, and CMS determines that the underlying conduct that would have led to the revocation is detrimental to the best interests of the Medicare program. Such conduct includes, but are not limited to, felony convictions AND Office of Inspector General (OIG) exclusions.”


 III. Why was the Preclusion List Created?  

In April of 2018, within the Federal Register Rules and Regulations update, the Department of Health and Human Services released information on policy changes to Medicare programs. In which, they discussed the Preclusion List and their reasoning for establishing the new rule. It seems that CMS has given a few reasons for putting this new rule into effect:
  • “To focus on preventing payment for Part D drugs prescribed by demonstrably problematic prescribers”
  • “Reduce the burden on Part D prescribers and Medicare Advantage providers without compromising our program integrity efforts.” And to
  • “To replace the Medicare Advantage (MA) and prescriber enrollment requirements.”
By doing this, CMS believes that it will save $34.4 million dollars in 2019. These savings would be derived from the removal of the requirements for Part D prescribers and Medicare Advantage providers and suppliers to enroll in Medicare prior to providing health care services and items.

 IV. How do I Know if I am Precluded?  

Unlike the Office of Inspector General’s (OIG) monthly exclusion list, the Preclusion list will not be shared publicly. Precluded providers however will receive notice in a variety of ways. First, CMS will issue an initial email notification to the precluded providers using their email addressed which they provided to either the Provider Enrollment, Chain and Ownership System (PECOS), the National Provider Plan and Enumeration System (NPPES), or from the Medicare enrollment system of record. The Medicare Administrative Contractor (MAC) will also follow up by sending a written notice through the mail to the precluded provider before they are added to the Preclusion List. Within this letter you will also be informed on why exactly you are precluded, the date that your preclusion will go into effect, and your applicable appeal rights.

 V. Are Dentists at Risk of Being Precluded?  

YES.
If a dentist has been revoked from Medicare, is under an active re-enrollment bar, and CMS has found that the actions that led to their original revocation is a risk to the integrity of the Medicare program or has engaged in behavior for which CMS could have excluded them from participating in Medicare if they had enrolled.
 
 VI. When will the Preclusion List go into Effect?  

The first list of providers that were to be precluded were published and were sent notice on January 1, 2019. However, beginning April 1, 2019 Part D sponsors will become required to reject any prescriptions for Medicare Part D drugs that are prescribed by an individual or entity that is on the Preclusion List. Medicare Advantage (MA) plans will also become required to deny payments for any healthcare service or item that was provided by and individual or entity that is on the Preclusion List.

 VII. Is This the Same as the OIG’s Exclusion List?  

The OIG Exclusion List is NOT the same as this new CMS List. That being said, there is some overlap. If you have been excluded, you can still find yourself on the Preclusion List if you fall into the either of the two criteria listed above under the “How Does Someone End up on The Preclusion List? ” section. As you can see in the diagram below, there is some overlap, but not much.

New CMS Preclusion List


 VIII. How can I Screen for Precluded Individuals or Entities?  
Unfortunately, access to the Preclusion List is Extremely Restricted. However, under certain circumstances, we here at Exclusion Screening, LLC can provide guidance and help. Contact us info@exclusionscreening.com or give us a call at (800)-294-0952 for a free consultation and quote.

A Review of OIG Enforcement Actions in Fiscal Year 2018

By Cason Liles

OIG in Fiscal Year 2018(February 6, 2019): The Department of Health and Human Services (HHS), Office of Inspector General (OIG) is an independent, objective law enforcement and investigative agency that is responsible for protecting the financial integrity of the more than 300 programs that are administered by HHS.  Collectively, these programs represent approximately 24% of the Federal budget.  Although OIG is responsible for investigating allegations of fraud, waste and abuse related to literally hundreds of HHS programs, most of OIG’s investigative and enforcement activities arise out the Medicare and Medicaid programs.  Simply put, OIG’s mission is fighting fraud, waste and abuse.  In the pursuit of this mission, OIG aggressively investigates allegations of wrongdoing to identify and recover improper payments made to health care providers, suppliers and other parties who have engaged in fraudulent, wasteful or abusive conduct.  One of the key tools used by OIG to protect patients and safeguard the financial integrity of the Medicare and Medicaid programs is its authority to exclude individuals and entities from participation in Medicare, Medicare and other Federal health care benefit programs.  This article examines a number of the exclusion-related enforcement actions taken by the OIG in Fiscal Year (FY) 2018.  

 I. An Overview of FY 2018 Exclusion Actions:  


At the outset, it is important to keep in mind that “exclusion” actions aren’t new.  They were first mandated in 1977 as part of the “Medicare-Medicaid Anti-Fraud and Abuse Amendments,” Public Law 95-142.  The responsibility for imposing mandatory and permissive exclusion actions rests with OIG.  As in prior years, OIG aggressively exercised its exclusion authorities in FY 2018 and excluded 2,712 individuals and entities from participating in Federal health care benefit programs.  A number of the more noteworthy exclusion actions taken in FY 2018 are outlined below:


 II. Noteworthy Civil Monetary Penalty and Affirmative Exclusion Actions Taken by OIG in FY 2018:  


Oklahoma.
 
(January 2018). Assisted Living Facility Settles Case Involving Excluded Individual.  In this case, an Oklahoma assisted living facility (ALF) improperly employed an excluded individual who was hired to work as an “Admissions Specialist.”  As a result of the organization’s wrongful employment of this excluded individual (likely caused by a failure to properly screen all of its staff), the ALF may have faced significant civil monetary penalties (CMPs).  Ultimately, the ALF entered into a settlement agreement with OIG and agreed to pay more than $96,000.  This case illustrates the importance of screening ALLemployees, not merely direct patient caregivers such as physicians, nurses, medical assistants and other licensed health care professionals. 


Oklahoma.
 
(February 2018). Management Company Settles Case Involving Excluded Individual.  An organization that owns and manages a skilled nursing facility in Oklahoma City, Oklahoma, was alleged to have hired a licensed practical nurse (LPN) who was excluded from participating in any Federal health care program. An OIG investigation found that this individual had provided items or services that were reimbursed by Federal health care programs. This resulted in the skilled nursing facility entering into a settlement agreement with OIG and agreed to pay more than $140,000 to the government.


New Jersey.
 
(March 2018). Pharmacy and Owner Settle Case Involving Excluded Individual.  In this New Jersey case, a pharmacy and its owner were alleged to have employed a pharmacist who was excluded from participating in Federal health care benefit programs. Upon investigation it was found that this excluded pharmacist had provided items or services to patients that were reimbursed by Federal health care programs. The pharmacy entered into a settlement agreement with OIG and agreed to pay more than $300,000 to the government.


Pennsylvania.
 
(March 2018). Physician Agrees to Voluntary Exclusion.  In this case, a Pennsylvania physician accepted an exclusion from participation in all Federal health care programs for 10 yearsunder 42 U.S.C. § 1320a-7(b)(6)(B).[1]OIG alleged that the physician had  issued opioid prescriptions to patients that were in excess of their needs and fell substantially short of the professionally recognized standards of care. This cause illustrates just how serious the OIG currently is when dealing with these opioid-related issues.


New Jersey.
(September 2018).  New Jersey Health Center Pays Penalties for Improperly Employing an Excluded Individual.  In this New Jersey case, a community health center was alleged to have improperly employed a physician who was excluded from participation in Federal health care benefit programs. Notably, the excluded physician was found to be working in quality assurance and risk management.  Additionally, the excluded physician had provided items and services that were ultimately billed to Federal health care programs. As a result of this wrongful hire, the community health center entered into a settlement agreement with OIG that required the organization to pay more than $98,000.

 
Illinois. (September 2018).  Psychologist Agrees to 20-Year Exclusion.  In this Illinois case, a licensed psychologist was alleged to have billed for psychological services that were either: (1) not provided as claimed; (2) false or fraudulent because the dates of service billed were times when either the patient was hospitalized, OR the psychologist was travelling out of the state. Based on the allegations, the psychologist agreed to be excluded from participation in all Federal health care programs for a period of 20 years under 42 U.S.C. § 1320a-7(b)(7).[2]


Tennessee.
 
(September 2018).  Advanced Practice Nurse (APRN) Agrees to 10-Year Exclusion.In this Tennessee case, an advanced practice nurse (APRN) agreed to be excluded from participation in Federal health care benefit programs for 10 yearsunder 42 U.S.C. § 1320a-7(b)(6)(B) and42 U.S.C. § 1320a-7(b)(6).[3]  Importantly, this particular exclusion action was imposed due the APRN’s inappropriate opioid prescribing practices.  It is also worth noting that the OIG further alleged that the APRN prescribed controlled substances without appropriately documenting: (1) A clear objective finding of a chronic pain source to justify the ongoing and increasing prescribing; (2) Attempts to identify the etiology of reported pain; (3) A thorough history or adequately inquiring into potential substance abuse history; or (4) A written treatment plan with regard to the use of the prescriptions.  If OIG audits your controlled substance prescribing practices, the agency will be looking for each of these items in the record.


 III.   Noteworthy Exclusion Self-Disclosures Reported to OIG in 2018:  


Hawaii.
 
(January 2018). General Hospital Self-Discloses Employment of Excluded Individual. After voluntarily self-disclosing the employment of an excluded individual, a Hawaii based hospital agreed to pay $100,000 for accusations of violating the Civil Monetary Penalties Law. OIG alleged that the hospital knew or should have known that the individual had been excluded from participation as a provider in Federal health care benefit programs.


Rhode Island.
 
(March 2018). Nursing Home Self-Discloses Employment of Excluded Individual.  A nursing home in Rhode Island learned that it had improperly employed an individual who was excluded from participation in Federal health care benefit programs. After subsequently choosing self-disclosing of this employment to OIG, the nursing and rehabilitation center agreed to pay more than $42,000 to resolve violations of the Civil Monetary Penalties Law.


Ohio.
(April 2018). Ohio County Health District Self-Discloses the Improper Employment of Excluded Individual.  In this Ohio case, a County Health District agreed to pay more than $55,000 for alleged violations of the Civil Monetary Penalties Law. The County Health District voluntarily disclosed that it had improperly employed an individual that it knew or should have known was excluded from participation in Federal health care benefit programs.


Texas.
(September 2018). Rehabilitation Center in Texas Self-Discloses Employment of Excluded Individual.  In this Texas case, arehabilitation and care center learned that their organization had unwittingly hired an individual that had been excluded from participation in Federal health benefits programs.  To their credit, the rehabilitation center self-disclosed the violation directly to OIG.  Ultimately, the rehabilitation center was required to pay more than $129,000 in civil monetary penalties to the government in connection with this wrongful employment.


 IV.
Points to Consider:  


 
As several of the cases above reflect, opioid related audits and investigations are increasingly resulting in OIG exercising its permissive exclusion authority under 42 U.S.C. § 1320a-7(b)(6).  It is important to keep in mind that this statutory provision can be applied to practically any situation where a health care provider’s services “fail to meet professionally recognized standards of health care.”  Now, more than ever before, it is imperative that health care providers remain up-to-date with respect to the standards of care applicable in their specific field of practice.  Additionally, their compliance with applicable standards of care must be fully and accurately documented their actions in the patient’s medical records.


Health care providers and suppliers MUST ensure that they are taking the appropriate steps to ensure that their employees, agents, contractors and vendors have not been excluded from participation in Federal health benefit programs. Based on the OIG’s actions in 2018, we should fully expect for the agency to continue to increasingly focus on exclusion-related administrative actions in 2019.


Is your practice or health care organization meeting its screening obligations?  Call the experienced staff at Exclusion Screening for help with your screening needs.

[1]42 U.S.C. § 1320a-7(b)(6)(B) permits the OIG to impose a permissive action if an individual or entity has furnished or caused to be furnished items or services to patients (whether or not eligible for benefits under subchapter XVIII of this chapter or under a State health care program) substantially in excess of the needs of such patients or of a quality which fails to meet professionally recognized standards of health care.”

[2]42 U.S.C. § 1320a-7(b)(7) is one of the permissive exclusion authorities that may be exercised (at the discretion of OIG). This permissive exclusion authority is used when excluding an individual or entity for Fraud, kickbacks, and other prohibited activities.”

[3]42 U.S.C. § 1320a-7(b)(6) is another one of the permissive exclusion authorities that may be imposed, at the sole discretion of OIG.  This permissive exclusion authority is used when excluding an individual for the wrongful submission of Claims for excessive charges, unnecessary services or services which fail to meet professionally recognized standards of health care, or failure of an HMO to furnish medically necessary services.”

Concealing Information Regarding an Excluded Party and Lying on a Medicare CMS-855a Enrollment Application Will Swiftly Make a Bad Situation Even Worse!

CMS-855a Enrollment Application(January 8, 2019): Since first being enacted in 1965, Congress has enacted a number of measures to safeguard the financial integrity of the Medicare and Medicaid programs. The Medicare-Medicaid Anti-violations Fraud and Abuse Amendments of 1977 (Public Law 95-142) are among the most significant. In addition to making of the Federal Anti-Kickback Statute a felony, the legislation also mandated that physicians and other practitioners convicted of program-related crimes be excluded from participating in Medicare and Medicaid.  Since 1977, the scope of mandatory and permissive bases that can result in program exclusion has expanded significantly. Exclusion actions are the proverbial “kryptonite” of administrative sanctions that may be imposed on health care providers and suppliers.  As the exclusion statute now stands, if a health care provider or supplier is excluded from participation in Medicare, Medicaid or other Federal health care benefit plans, no payment can be made for any of the services or items “furnished, ordered, or prescribed by an excluded individual or entity.”[1]

From a practical standpoint an excluded individual or entity cannot bill or work for any practice or entity that bills Federal health care benefit programs. The Department of Health and Human Services (HHS), Office of Inspector General (OIG), is the agency responsible for imposing Federal exclusion actions[2] that are mandated[3] under the law. At its discretion, the OIG may also choose to pursue an exclusion action against individuals and entities that have been subjected to a number of other adverse actions.[4] Although both mandatory and permissive exclusion actions are administrative in nature, the seriousness of an exclusion action cannot be understated. This article examines a recent case where the failure to disclose the ownership of a home health agency by excluded individuals resulted in the indictment and conviction of the agency’s owners and two members of the agency’s staff.

 I. The Medicare Enrollment Process is the First Line of Defense to Prevent Program Fraud:

Among its many responsibilities, the Centers for Medicare and Medicaid Services (CMS) is responsible for administering the Medicare, Medicaid and Children’s Health Insurance Program (CHIP) health care benefits programs. To serve as a participating provider or supplier in the Medicare program, an enrollment application must first be completed.[5]  The specific enrollment application form to be completed, varies depending on the type of provider or supplier entity. For example, home health agencies are required to complete enrollment application CMS-855A.[6] 

A number of items in the enrollment application are specifically intended to identify various adverse actions that may have been imposed against an entity, its owners or managers.  For example, applicants must disclose whether the provider or supplier has a history of any final adverse actions, such as convictions, exclusion actions, revocation actions, or suspensions. Administrative adverse legal actions that must be reported are listed on page 16 of the CMS-855a.  As the application states, the following administrative adverse actions must be disclosed:


If the applicant has a history of one or more final adverse legal actions (either a qualifying conviction or one of the administrative actions listed above), the actions must be detailed in SECTION 3 of the CMS-855a.



Finally, SECTION 15 of the CMS-855a requires that applicants attest to the following: 
SECTION 15, further requires that applicants certify that all of the information contained in CMS-855a is “true, correct and complete. . .”

 II. What’s the Best Way to Make an Administrative Exclusion Action Even Worse? Lie About it:

A recent criminal prosecution out of the Northern District of Texas provides a real-life example of how a health care provider can make things go from bad to worse.  In that case, the concealment of an administrative exclusion action, along with the falsification of Medicare and Medicaid enrollment and re-validation paperwork, resulted in the criminal prosecution and conviction of four individuals associated with this north Texas home health agency.  A chronology of the case is set out below:
  • April 2001. A north Texas-based home health agency (referred to as “NTHHA”) was incorporated as a Texas limited liability company with a business address in Garland, Texas. After being incorporated, NTHAA applied to become a participating home health provider in the Medicare program. The agency also applied to provide Personal Assistance Services (PAS) to Medicaid beneficiaries. The home health agency was owned by Defendant #1 (who also served as Administrator and Director of the agency), and his wife, Defendant #4. 
  • April 2010. The owner of NTHAA (Defendant #1) and one of the agency’s management officials who served as an Administrator / Director of the agency (Defendant #2) were facing state felony charges associated with the delivery of a health care item under the Medicaid program. More specifically, the Medicaid Fraud Control Unit (MFCU) of the Texas Attorney General’s Office conducted an investigation of the defendants in connection with defendants both played roles in the wrongful billing of
  • November 2011. Defendant #3 (an Administrator and Registered Nurse for NTHHA), signed and submitted a Medicare re-validation application for NTHHA. The government alleged that the application submitted by Defendant #3 concealed and failed to disclose that Defendant #1 was an owner of the home health agency and that Defendant #2 was a manager at the same agency. Moreover, Defendant #3 failed to disclose that both Defendant #1 and Defendant #2 had been indicted on felony charges associated with the delivery of a health care item.
  • March 2012. Defendant #1 filed a Texas Franchise Tax Public Information Report for NTHAA and failed to identify himself as an officer, director or member of the home health agency.
  • June 2012. Defendants #1 and #2 pled guilty Texas State District Court to a Class A Misdemeanor Offense of Attempted Theft, in violation of PENAL CODE ANN. § 31.03, related to their 2010 indictment. The defendants were placed on community supervision for one year and an Order of Deferred Adjudication was entered by the District Court. In approximately December 2012, the defendants were granted early discharge from their community service obligations the District Court dismissed all of the proceedings, including the indictments against the defendants.
  • January 2013. The OIG notified Defendants #1 and #2 that they were being excluded from participation from Medicare, Medicaid and all Federal health care benefit programs for a period of 5 years pursuant to Section 1128(a)(1) of the Social Security Act, 42 U.S.C. § 1320a-7(a)(1). Both defendants appealed the exclusion, but the 5-year period of administrative exclusion was upheld by the Administrative Law Judge assigned to hear their respective cases. 
  • April 2013. Defendant #1 signed and filed a Texas Franchise Tax Public Information Report for NTHAA which listed himself as an Administrator and Director of NTHHA.
  • May 2013. Defendant #3 signed and submitted a contract re enrollment application with the Texas Department of Aging and Disability Services (DADS). The re-enrollment application falsely certified that no persons with an ownership interest or managerial role at NTHHA had been convicted of a crime relating to a Federal health care program.  During this time period, Defendant #3 also falsely certified that none of the principals, including officers, directors, owners, partners, or person’s having a primarily management or supervisory responsibility in NTHHA were presently excluded from participation in the Medicare or Medicaid programs.
  • May 2014. Defendant #1 signed and filed a Texas Franchise Tax Public Information Report for NTHAA which listed himself as an Administrator and Director of NTHHA.
  • May 2015. Defendant #1 signed and filed a Texas Franchise Tax Public Information Report for NTHAA which listed himself as an Administrator and Director of NTHHA.
  • September 2015. Defendant #1 opened a bank account under the name of the home health agency, NTHHA. 
  • October 2015. Defendant #3 signed and submitted a Medicaid Advantage Plan provider application for NTHHA which falsely certified that no employees of the agency had been, or were currently excluded, from participation in a government program such as Medicare or Medicaid. The Medicaid Advantage Plan provider application submitted also falsely certified that no representatives of NTHAA had pled guilty to any legal action. Finally, Defendant #3 concealed and failed to disclose that Defendants #1 and #2 had no ownership interests and managerial roles in NTHAA.
  • October 2015. Defendant signed and submitted a provider application to a second Medicaid Advantage Plan, certifying that NTHHA had not been excluded under its current or former name or business identity from any Federal or State health care program.
  • January 2013 – May 2016. Despite their exclusion in January 2015, Defendant #1 and Defendant #2, continued to submit home health and PAS claims to Medicare and Medicaid for payment through May 2016. More than $4 million was billed to the Medicare and Medicaid during this period and Defendant #1 paid himself approximately $346,000 from NTHHA’s bank accounts.   Moreover, during this period, Defendant #1 paid Defendant #2 approximately $77,000 from NTHHA bank accounts.
  • June 2016. In June 2016, a Federal Grand Jury in the Northern District of Texas indicted Defendant #1, Defendant #2, and Defendant #3 (an Administrator and Registered Nurse for NTHHA) for “Conspiracy to Commit Health Care Fraud.”  (Violation of 18 U.S.C. 1349) and (18 U.S.C. 1347).  The government alleged that from approximately April 2010 through May 2016, the three defendants conspired to defraud the Medicare and Medicaid program by making materially false and fraudulent representation and promises in connection with the delivery of services billed to the Medicare and Medicaid programs.
  • December 2017. A Superseding Indictment by a Federal Grand Jury was issued in this case, charging Defendant #1 and Defendant #3 with additional counts of “False Statements in Health Care Matters.” (Violation of 18 U.S.C. 1035). Two unindicted physician co-conspirators were also named in the Superseding Indictment. Additionally, an additional defendant was added to the indictment. Defendant #4 (the wife of Defendant #1) was indicted for one count of “Conspiracy to Commit Health Care Fraud” for her role in the concealment of and falsification of ownership interests in NTHAA.

  • October 2018. After a six-day trial, a Federal jury found that: (A) Defendant #1 was guilty of Conspiracy to Commit Health Care Fraud and of making a False Statement for his role in concealing his ownership interest in NTHAA; (B) Defendant #2 was guilty of Conspiracy to Commit Health Care Fraud for his role in concealing his ownership interest in NTHAA; and (C) Defendant #3 was guilty of Conspiracy to Commit Health Care Fraud and of making a False Statement for her role in concealing the ownership interests of Defendant #1 and Defendant #2.  Defendant #3 was also found to have falsely certified that no one associated with home health agency was excluded.  Moreover, she supposedly indicated that another party owned NTHAA, when in fact, Defendant #1 and Defendant #2 were both excluded parties and had an ownership interest in the agency. 

 III.  How Did a State Class A Misdemeanor That Was Ultimately Dismissed Lead to an OIG Exclusion Action?

 In the case discussed above, the OIG excluded Defendants #1 and #2 from participation in the Medicare and Medicaid programs for 5 years, citing the mandatory exclusion requirements of Social Security Act, 1128(a)(1).
Let this sink in for a moment . . . the defendants pled guilty to a state Class A Misdemeanor in Texas District Court, and the charges, including the indictment, were later dismissed pursuant to an Order of Deferred Adjudication by the Texas State District Court.  Nevertheless, the OIG really had no choice but to exclude the defendants. 
The mandatory exclusions of Defendant 1# and Defendant #2 were brought under Section 1128(a)(1) of the Social Security Act, 42 U.S.C. § 1320a-7(a)(1). This provision of the Act requires the exclusion of any individual or entity convicted of a criminal offense related to the delivery of an item or service under the Medicare or Medicaid programs.[7] Importantly, this mandatory exclusion provision is not limited to only felony convictions.  It also covers misdemeanor convictions. Additionally, it is important to note that the Social Security Act defines “conviction” as including a number of situations.  A summary of actions that qualify as a conviction is set out below:

Social Security Act § 1128(i)(1): When a judgment of conviction has been entered against the individual by a Federal, State, or local court.

Social Security Act § 1128(i)(2): When there has been a finding of guilt against the individual by a Federal, State, or local court. 

Social Security Act § 1128(i)(3): When a plea of guilty or nolo contendere by the individual has been accepted by a Federal, State, or local court.

Social Security Act § 1128(i)(4): When the individual has entered into participation in a first offender, deferred adjudication, or other arrangement or program where judgment of conviction has been withheld

Simply put, the OIG was required by law to exclude Defendant #1 and Defendant #2 from the Medicare program for 5 years, despite the fact that the conviction was a state misdemeanor that was ultimately discussed pursuant to an Order of Deferred Adjudication.

 IV. Lessons Learned:

Lesson #1. Always consider the administrative ramifications of accepting a plea agreement. Even if the charges are later dismissed under a deferred adjudication agreement. pleading guilty to a Class A misdemeanor will lead to an individual’s mandatory exclusion from participating in the Medicare program if the underlying criminal offense was related to the delivery of an item or service under the Medicare or Medicaid programs.  In this case, the OIG had no choice but to exclude these individuals from the Medicare program for 5 years under Section 1128(a)(1) of the Social Security Act.  

Lesson #2.  Medicare and Medicaid providers need to exercise caution when completing Medicare and Medicaid program enrollment applications.  As this case reflects, Federal prosecutors won’t hesitate to pursue false or deceitful conduct that has been taken to hide an excluded party’s ownership interest or involvement with a health care entity. Although an exclusion action is only an administrative sanction, if you are excluded from participation in the Medicare program and attempt to set up a “straw owner” in an effort to hide your ownership interest in a health care entity, you risk turning an administrative sanction into a criminal case.

 V. Concluding Remarks:

In this case, the defendants’ worst enemies were, in fact, themselves.  After being excluded form participation in the Medicare program. The defendants failed to properly divest and dissociate themselves from the home health agency.  Instead, they essentially doubled-down and took steps to conceal their ownership and involvement with the home health agency. This false and deceitful conduct ultimately led to their indictment on federal criminal charges.  Additionally, their actions led to the criminal involvement of another home health agency management official (Defendant #3), and the agency owner’s wife (Defendant #4).  Ultimately, all four individuals were convicted of “Conspiracy to Commit Health Care Fraud,” making a“False Statement,” or both counts. All of the defendants are currently awaiting sentencing.

As a participating provider or supplier in the Medicare, Medicaid or other Federal health care program, you have an affirmative obligation to ensure that no owners, employees, agents or contractors have been excluded from participation in one or more of these programs.  The folks at Exclusion Screening can greatly assist you in meeting those obligations. They can be reached at:  1 (800) 294-0952.

[2]States also have the ability to exclude individual and entities from participating the state’s Medicaid program.
[3]Mandatory exclusion actions must be imposed by the OIG if an individual or entity is convicted of a number of felony criminal health care related statutes or convictions related to fraud, theft of other financial misconduct.  A list of mandatory exclusion bases can be found in the following article.
[4]Permissive exclusion actions are not required by law but may be pursued at the option of the OIG.  A list of permissive exclusion bases can be found in the following article.  
[5]After successfully enrolling in the Medicare program, 42 CFR §424.515 requires that in order to maintain Medicare billing privileges, a provider or supplier (other than a DMEPOS supplier) must resubmit and recertify the accuracy of its enrollment information generally every 5 years. DMEPOS Suppliers must revalidate at least every three years.
[6]A copy of CMS-855A can be found here.
[7]See, Tamara Brown, DAB No. 2195 (2008); Thelma Walley, DAB No. 1367; Boris Lipovsky, M.D., DAB No. 1363 (1992); Lyle Kai, R.Ph., DAB CR1262 (2004), rev’d on other grounds, DAB No. 1979 (2005); see also Russell Mark Posner, DAB No. 2033, at 5-6 (2006).

What Providers Need to Know About Medicaid Exclusions in Texas: Exclusion Screening Requirements and Best Practices for Compliance

Texas Medicaid Exclusions(December 17, 2018):   The Texas Medicaid Program will not pay for any item or service furnished directly or indirectly by individuals or entities that have been excluded from a State or Federal health care program.  This results in a broad “Payment Prohibition” that is enforced by the Texas Health and Human Services Commission, Office of Inspector General (HHSC-OIG) through a comprehensive regulatory scheme that includes the imposition of strict provider exclusion screening requirements. This article will discuss how providers are impacted by these regulations and the exclusion screening obligations they impose; the risks of compliance failures; and it will suggest best practices to help providers to help providers comply with their obligations and avoid those risks.

I. What is a Medicaid Exclusion?
Exclusions” are final administrative action by a State or Federal agency that bars an individual or entity from participating in one of its benefit programs. When a State forecloses participation in its Medicaid programs, that action is often referred to as a “Medicaid Exclusion.” Similarly, when the Department of Health and Human Services (HHS), Office of Inspector General (OIG) bars participation in Medicare program, that is commonly referred to as a “Medicare Exclusion.”  Texas Medicaid Exclusions are posted on database maintained on the Texas HHSC-OIG website, and Medicare Exclusions are posted on the OIG’s “List of Excluded Individuals and Entities” (LEIE) which is maintained on its website.

II. Who Gets Excluded? Why are Exclusions Imposed?
Medicaid Exclusions in Texas are imposed by HHSC-OIG pursuant to Texas Administrative Code articles §371.1705 (Mandatory Exclusions) and §371.1707 (Permissive Exclusions). The primary reasons for the agency to take this action are:
  • A conviction for program-related fraud, or patient abuse,
  • Adverse actions by licensing boards such as the Board of Nursing or the Medical Board,
  • Being excluded by from the Medicare program.[1]

Texas Medicaid ExclusionsSince exclusions are designed to protect patients and the programs that serve them, it is not surprising to see that that most are based on fraud, adverse license board actions or exclusions imposed by the OIG. The chart showing the breakdown of exclusions in Texas by occupation over the  last five years is also consistent with this focus as Nurses account for almost half  of all exclusions during that period. However, when added to others who receive  licenses (physicians, pharmacists, etc.) those with a license account for almost  three fourths of all exclusions in Texas.



III.  What is the Effect of a Medicaid Exclusion?
“Exclusions [are] one of the most important tools we have to protect beneficiaries and stem fraud and abuse [and]…ensure that Medicare, Medicaid and other federal health care programs are protected. [W]e need…to help make sure excluded individuals are not involved in any way in the care of… beneficiaries.” Inspector General June Gibbs Brown,[2]
Medicaid Exclusions imposed by HHSC-OIG “restrict individuals (and entities) from receiving any reimbursement for items or services furnished, ordered, or prescribed.” Texas Medicaid Provider Enrollment Manual, 1.3.1.  This sanction is commonly referred to as a “Payment Prohibition,” and TAC Rule §371.1705(e)(4) describes the effect of sanction as follows:
  • The person or entity will not be reimbursed for any item or service they may furnish.
  • The person or entity may not bill or receive payment, directly or indirectly, from any Title V, XIX, or XX, or other HHS programs, or from the Medicaid program.
  • The person or entity may not assess care, or order or prescribe services to Title V, XIX, or XX, or other HHS programs recipients either directly or indirectly.
  • A clinic, group, corporation, or other entity is not allowed to submit claims for any assessments, services, or items provided by a person who is excluded from participation.
  • Any entity that employs or contracts with an excluded entity may not include those costs in any form of payment (i.e. a cost report, document used to determine payment rates, etc.).
  • Excluded parties that submit claims are subject to administrative damages and penalties.
States also must terminate the participation of any provider that has been terminated for cause from any other State Medicaid program pursuant.  The requirement, contained in Section 6501 of the Affordable Care Act, is intended to strengthen Medicaid program integrity by stopping providers excluded in one State from moving to another and providing services there. Thus, stated simply, a Medicaid Exclusion in Texas makes an individual radioactive when it comes to providing services in Texas or in any other State benefit program. 

IV. Provider Exclusion Screening Requirements:[3]
Medicaid Exclusions are only effective if the payment prohibition is enforced and Texas seeks to achieve this goal largely by imposing extensive “exclusion screening” obligations on its Medicaid providers.  These exclusion screening requirements are outlined and described below:

A. Texas Medicaid Enrollment Manual: Basic Screening Obligations
Section 1.3.1 of the Texas Provider Enrollment Medicaid Manual states that current providers and applicants “must screen their employees and contractors every month” as a “condition of the provider’s enrollment or re-enrollment into state health-care programs.”  Providers are advised that they can accomplish this by searching the Texas Medicaid Exclusion List and the LEIE – the Medicare Exclusion List. The Texas list is searchable and it can also be downloaded from the HHSC-OIG website at: https://oig.hhsc.state.tx.us/Exclusions/Search.asp.  The LEIE can be downloaded from the HHS-OIG website at http://www.oig.hhs.gov/fraud/exclusions.asp, and it is also a searchable database.


While the primary part of the Medicaid Manual does not refer to screening upon hire, there are a large number of programs that operate under the umbrella of the Medicaid Program with manuals of their own that supplement the main Provider Enrollment Manual.[4] The manuals of at least 20 of these “programs within the program” have a an appendix that states that requires providers screen upon hiring and contracting, and least monthly thereafter, to ensure compliance with Federal regulations at 42 CFR 1001.1901(b) and State Medicaid Director Letter #09-001 from the Centers for Medicare & Medicaid Services (CMS).

B. Texas Admin. Code § 352.5: Screening Requirements with Enrollment and Re-Enrollment And Expands the Scope of the Exclusion Screening Obligation.
TAC § 352.5 applies specifically to enrollment and re-enrollment, but it expands the scope of the obligation of provider exclusion screening in two ways.  The regulation adds “owners and managers” to employees and contractors as those who have to be screened, but, more importantly, it seemingly expands the scope of the screening requirement to “participation in a program under Title XVIII, XIX, or XXI of the Social Security Act.”  As Titles XVIII, XIX, and XXI refer to the Medicare Program, the Medicaid Program and the State Children’s Health Program (CHIPs), the regulation clearly seems to require providers to screen every State Exclusion List in addition to the Texas Medicaid Exclusion List and the LEIE.

C. Screening Obligations Arising from Disclosure Obligations in the Enrollment Process
The application also process expands the scope and extent of the obligation to screen on the part of providers – though it does so in a different way.  As part of the process, all “principals” and “subcontractors” [5] of the applicant are required to fill out a Provider Information Form (PIF-2) and state whether they have ever been excluded or debarred from any state or federal program, and the applicant must attest that he has carefully reviewed the information in the PIF-2 and “certify it is current, complete, and correct.
This is a significant expansion of the provider exclusion screening obligation because, as can be seen in FN5, the definition of people that may qualify as either a principal or subcontractor is very broad and could result in the inclusion of a large number of who might only be remotely connected to the applicant.  As such, a prudent applicant will not rely on his personal knowledge of the principal or contractor or on their answers on the form; instead, he will screen each principal or subcontractor to ensure their exclusion status.  Additionally, the fact that the question is whether they have ever been excluded or debarred from “any state or federal program” strongly supports the view that TAC § 352.5 intends to require broad screening that includes all State Exclusion Lists.

D. The Provider Agreement Confirms Exclusion Screening Compliance
The Texas Medicaid Provider Agreement itself, the final step of the enrollment chain, also contains significant exclusion screening provisions.  For example, Paragraph 1.2.1 states:
 
By signing this Agreement, Provider certifies that the provider and its principals have not been excluded, suspended, debarred, revoked or any other synonymous action from participation in any program under Title XVIII (Medicare), Title XIX (Medicaid), or under the provisions of Executive Order 12549, relating to federal contracting. Provider further certifies that the provider and its principals have also not been excluded, suspended, debarred, revoked or any other synonymous action from participation in any other state or federal health-care program.

Paragraph 9.1 affirms provider’s compliance with TAC § 352.5 stating:

Provider, in accordance with TAC 352.5 (b)(1), has conducted an internal review to confirm that neither the applicant or the re-enrolling provider, nor any of its employees, owners, managing partners, or contractors (as applicable), have been excluded from participation in a program under Title XVIII, XIX, or XXI of the Social Security Act.

[Provider] attest[s] that an internal review was conducted to confirm that neither the applicant or the re-enrolling provider nor any of its employees, owners, managing partners, contractors have been excluded from participation in a program under the Title XVIII, XIX, or XXI of the Social Security Act. 
Yes    No   

Paragraph 12.1 states: By signing below, Provider acknowledges and certifies:

(c) Provider has carefully reviewed all of the information submitted in connection with its application to participate in the Medicaid program, including the provider information forms…and certifies that this information is current, complete, and correct.

(d) Provider agrees to review and update any information in the application to maintain compliance with and eligibility in the Medicaid program and continued participation therein.

V.
Enforcement:
Excluded individuals and entities may not “bill or receive payment, directly or indirectly, from any Title V, XIX, or XX, or other HHS programs, or from the Medicaid program.” This limitation includes assessing care, ordering or prescribing services, having a separate entity indirectly submitting claims, and being employed by a third party who then includes those costs in cost reports or some other form of payment. TAC § 371.1705. Violations can result in federal civil money penalty or criminal liability under § 1128A and § 1128B of the Social Security Act, and the imposition of administrative damages and/or penalties by the State (TAC § 371.1655).
The HHSC-OIG is responsible for enforcing state laws and regulations relating to the Medicaid program and can assess the following as damages and penalties for exclusion violations pursuant to §32.039 (1) the amount paid plus interest from the date on which the payment was made; and (2)  an administrative penalty up to twice the amount paid; and (3) not more than $10,000 for each violation.[6]
HHSC-OIG’s Chief Counsel division is primarily involved in Medicaid exclusion enforcement.  The General Law section within the HHSC-OIG is responsible for taking initial actions that relate to excluding providers, and the Litigation Section actually processes provider enrollment terminations and exclusions.  The Medicaid Program Integrity division (MPI) may also be involved in investigating potential exclusions and referring them to the Litigation Section. 

VI. Best Practices for Complying with the Texas Medicaid Exclusion Screening Requirements:
Compliance with exclusion screening requirements is of critical. Providers that fail to ensure the exclusion status of their owners, managers, employees and contractors risk overpayment liability,
the imposition of civil money penalties, and even possible criminal consequences.  Only proper exclusion screening can help providers mitigate or avoid these risks, and this section will suggest some practices which providers should consider including in their compliance plans. 

A. Screen all Employees.
Medicaid does not pay for services furnished directly or indirectly by an excluded entity. The same rule applies to Medicare, and the payment prohibition is broadly interpreted by federal authorities to include administrators, IT support personnel – even unpaid volunteers – if any of the services they provide contribute to any reimbursements that are received.[7] Texas Medicaid would almost certainly adopt a similar formulation and providers can try to identify employees that do not contribute to state or federal reimbursements.  But the scope of the payment prohibition is so broad that caution dictates against trying to “pick and choose” who to screen and it is a best practice for providers to screen all of their direct employees.

B. Owner, Officer, Manager and Director Screening.
As previously discussed, those who own and/or manage are included in the required screening and disclosure obligations imposed by Texas Admin. Code § 352.5, the mandatory disclosure requirements in the application process, and the provider agreement itself. Further, sections 1.2.2 and 12.1 of the provider agreement imposes an ongoing obligation on providers to report any changes in status of the disclosing individuals and entities.  As such, owners, officers, directors, managing employees and agents should also be included in the provider’s screening program.

C. Exclusion Screening of Contractors.
When deciding which contractors to screen, it is helpful to keep in mind that the aim of exclusion enforcement is to protect programs and their beneficiaries from untrustworthy providers and to deter improper conduct by others. As such, it is highly relevant if the conduct by the contractor is integral to care and creates a risk of patient harm.[8]  Guidance on translating this into a meaningful policy can be found in Corporate Integrity Agreements between providers and HHS-OIG confected in false claims act settlements the Special Advisory cited in footnotes 7 and 8. With this in mind, the following is offered to help providers develop their exclusion screening programs:
The contractors that provide the following (or similar) services should be screened as they would likely be viewed as persons who directly or indirectly support claims:[9]
  • Ambulance and other transportation service providers
  • IT and Security providers and their technicians
  • Medical equipment suppliers, Pharmacies and their Pharmacists, Labs
  • Direct service providers and agencies providing temporary direct services providers.
In most CIAs there are specific carve-outs for vendors whose sole connection to the provider is selling or providing supplies or equipment for which the vendor does not bill.  This is a common-sense exception that removes uncertainty with regard to a large class of vendors who provide supplies for which the provider is ultimately reimbursed.  The OIG will also allow providers to delegate the screening obligation to their contractors, but it does so with the following caveats: 1) the provider must insist on documentation that it has been performed, and 2) the provider remains responsible for their exclusion status and for any overpayment liability.
   
D. Special Rules for Billers and Coders.
Billers and third-party billing companies receive “special attention” when it comes to exclusion screening. It recognizes that providers may have to delegate their screening obligation to the billing contractor (particularly if it is a large one) and provides guidelines to be followed, however, it makes clear that the provide remains legally responsible for any overpayment liability. The OIG guidelines are found below, and providers should consider adopting some or all of them:
  • Require the biller to have (and produce) a policy of not employing excluded persons
  • Require the biller to screen its employees upon hire and monthly thereafter and maintain documentation of its screening
  • Require the biller to provide training to its employees in connection with the applicable requirements and preparation of the claims they are submitting
E. Screening Should be Done on Hire or Contract Initiation, and Monthly Thereafter.
As previously discussed on pages 2 and 3, providers must screen upon hire and monthly thereafter. This is supported by Section 1.3.1 of the Texas Provider Enrollment Medicaid Manual, Appendices to more than 20 individual Medicaid program provider manuals, 42 CFR 1001.1901(b) and State Medicaid Director Letter #09-001 from the Centers for Medicare & Medicaid Services (CMS).

F. Providers Should Screen all State Medicaid Exclusion Lists and the LEIE.
Based on the obligations contained in TAC § 352.5, the disclosure obligations in PIF-2, and the screening obligations identified in the Provider Agreement, providers should screen all 40 State Exclusion Lists as well as the LEIE – the Medicare Exclusion list.
It is also noted that Section 6501 of the ACA states that if a provider or entity is excluded from any State Medicaid program, then that provider or entity is excluded from participating in all State programs.[10]  Though it has not been fully settled as to how the statute will be implemented, this is completely consistent with the requirements of the authorities cited above.

G. Providers Should Hire a Vendor to Fulfill their Exclusion Screening Requirements.
Some providers are able to perform the “basic” screening obligation of checking the Texas Medicaid Exclusion List and the LEIE upon hire and monthly thereafter; but providers that attempt to screen all 40 State Exclusion Lists are almost certainly going to find the task to be insurmountable. The difficulty stems from several factors: there is no uniformity in in the list formats (they could be in WORD, Excel or PDF); each list contains different fields on information; States have different reasons and standards for including people on their list; and some States may have little to identify the person or entity beyond a name and city. In short, as with many other necessary services, providers need specialized assistance to meet a regulatory obligation. 
There are a number of reputable exclusion screening vendors, but providers should be aware that vendors, and the services they provide, can vary significantly.  Some vendors, for example, assist in investigating whether potential matches are actual matches whereas others may not; there can be differences in the sophistication of their software and the ability to identify “potential matches” when names are similar but not a “perfect match;” and the ease of access can differ.[11]

VIII.  Closing Comments:
The goal of this article was to help providers gain a better understanding of Medicaid Exclusions in Texas.  Exclusions are imposed on people and entities that pose risks to the Program and its beneficiaries, and that is why Texas Medicaid will not pay for any item or service furnished by them, whether directly or indirectly.  The article is also intended to help providers gain an understanding of their exclusion screening obligations and how they can fulfill them. 

——–
[1] As found on the HHSSC-OIG website: https://oig.hhsc.texas.gov/exclusions.  This chart was derived from an analysis of the Texas Exclusion List which can be found at the web address sighted above.
[2] Press Release announcing the issuance of the OIG’s “Special Advisory Bulletin on the Effects of Exclusion from Federal Health Care Programs, issued September 29, 1999. 
[3] “Exclusion Screening” refers to any process by which a provider determines if an individual or entity is barred from participating in a State of Federal benefit program due to his inclusion on one or more exclusion lists. The Medicare Exclusion List maintained by HHS-OIG is formally called the List of Excluded Individuals and Entities (LEIE) and 40 States have their own separate Medicaid Exclusion Lists. The remaining States rely on the LEIE, and each State has its own unique set of Exclusion Screening requirements.   
[4] The list is found on the HHSC-OIG website at: https://hhs.texas.gov/lawsregulation/handbooks/nfp/appendices/ appendix-vi-list-excluded-individuals-entities-leie. The programs to which it directly applies includes, but is not limited to, the following: the Community Living Assistance and Support Services Program Provider Manual (CLASS) as Appendix IX, the Deaf Blind with Multiple Disabilities  Program Manual (DBMD) as Appendix IV, the Medicaid Hospice Provider Manual (MHPM) as Appendix VII, the Medically Dependent Children Program Provider Manual (MDCP-PM) as Appendix X, the Nursing Facility Provider Manual (NFPM): as Appendix VI, and the Texas  Home Living Program Handbook (TxHmL): Appendix IV.
[5] Broadly defined in PIF-2 to include the following:
  • Those with direct or indirect ownership or control of 5% or more of the applicant;
  • Officers and directors, limited and non-limited partners, and all shareholders;
  • Managing employees or agents who exercise operational or managerial control, or who directly or indirectly manage the conduct of day-to-day operations;
  • Anyone with express or apparent authority to act for or on behalf of the provider;
  • Anyone with delegated management functions or responsibility for providing medical care; and,
  • Fiscal agents who can enter into a contract or agreement, or purchase of real
[6] If the violation impacts an elderly or disabled person (as defined by section 48.02 of the Human Resources Code), or a person less than 18 years of age, the penalty increases to between $5,000 and $15,000 per claim.
[7] Special Advisory Bulletin on the Effect of Exclusions from Participation in Federal Health Care Programs,” issued May 8, 2013.
[8] 81 Fed. Reg. 88, 334 (Dec. 7, 2016), See also, the Special Advisory Bulletin cited in FN 7.
[9] This a list of examples and not intended in any way to be a complete list.
[10] 42 U.S.C. § 1396(a)
[11] As noted in footnote 1, the author is a co-founder of Exclusion Screening, LLC, a third-party vendor of exclusion screening services.

OIG Exclusion Case Study: The Impact of a False Claims Act Judgment.

OIG Exclusion Case Study(August 23, 2018): In 2008, after learning that a Texas-based laboratory services company was submitting false claims to the Medicare program, a private citizen filed suit, on behalf of the United States, against the laboratory services company under the qui tam provisions of the civil False Claims Act. The qui tam provisions of the False Claims Act (31 U.S.C. §§ 3729 – 3733) allow private parties, commonly referred to as “whistleblowers” or “relators” to sue individuals and entities on behalf of the government if the defendants have “knowingly” submitted false claims to the government for payment.[1] In this case, the United States intervened in the case against the laboratory services company in 2011. In April 2018, the U.S. District Judge hearing the case ruled against the laboratory and its physician owner and awarded the United States $30.5 million for violations of the False Claims Act. Although there are a number of lessons (especially with respect to individual liability) to be learned from the underlying case, the purpose of this article to examine the collateral administrative actions that were taken against the physician owner and the laboratory services company.

I. Parallel Administrative Action — OIG Exclusion Action Overview: 

In a letter dated August 21, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) proposed to exclude the laboratory services company, and its owner, from participation in Medicare, Medicaid, and other Federal health programs under 1128(b)(7)[2] of the Social Security Act, for a period of 15 years. The OIG based its proposed exclusion action on the submission of claims from August 2009 to January 2010, that the laboratory and its owner (referred to as Petitioners in the administrative case), “ knew or should have known were not provided as claims and were false or fraudulent.”
[3]

II. Why Did the OIG Exercise its Exclusion Authority Under 1128(b)(7)? 

More often than not, when dealing with allegations of the civil False Claims Act, the OIG will choose to exercise its permissive discretion to exclude an individual or entity under Section 1128(b)(7) of the Social Security Act.[4] In this particular case, the OIG did, in fact, exercise its authority to exclude the Petitioners for 15 years.

III. Petitioners’ Appeal of the OIG’s Exclusion Decision: 

In response to the proposed OIG exclusion action, in October 2015, the Petitioners filed a timely request for a hearing before an Administrative Law Judge (ALJ). Additionally, due to the unavailability of the ALJ first assigned to hear the case, a different ALJ was appointed to handle the hearing on June 2017. Throughout this period (from late 2015 to early March 2018), both sides actively engaged in discovery and a lively exchange of motions ensued. Finally, in late March 2018, the substitute ALJ assigned to take over the case conducted an in-person hearing on the exclusion action.

IV. Issues Considered by the Administrative Law Judge:  

Simply stated, the ALJ hearing the case was required to consider two issues:
ISSUE #1: Did the OIG have a basis to exclude the Petitioners from participating in Medicare, Medicaid and all other federal care programs for 15 years under 42 U.S.C. §1320a-7(b)(7)? As set out under 42 U.S.C. §1320a-7(b)(7), the Secretary may exclude individuals and entities from participation in any federal health care program (as defined in section 1320a-7(b)(f)[5]) if the Secretary determines that individual or entity has committed fraud, kickbacks and / or other prohibited activities.[6]
As the ALJ’s opinion notes, after conducting the administrative hearing in this case, a U.S. District Court with jurisdiction over the parallel civil qui tam case issued a summary judgment decision against the Petitioners, finding the liable for violations of the False Claims Act. Despite the fact that the elements considered by the U.S. District Court were essentially the same as those to be considered by the ALJ when addressing the exclusion action, the ALJ chose not to broadly apply judicial estoppel in this case. This decision appears to have been primarily based on the fact that the time frames considered by the two forums were different. The ALJ also noted that he was charged to conduct a de novo review of the evidence when assessing the exclusion decision by the OIG. The ALJ therefore ruled that it was more appropriate for him to issue a decision based on the merits. Upon consideration of the evidence in this case, the ALJ found that:

(1) Petitioners presented or caused to be presented to an agency of the United States the claims at issue in this case.
(2) The claims Petitioners presented or caused to be presented to Medicare were false.
(3) Petitioners should have known that the claims for services they presented or caused to be presented to Medicare were false. 
(4) Petitioners’ equitable defenses do not serve to undermine the OIG’s basis for excluding them. 
(5) The statute of limitations is not implicated by discussion of Petitioners’ conduct preceding the six-year timeframe that forms the basis of the proposed exclusion.[7]

In light of these findings, after conducting a de novo review of the evidence, the ALJ found that the OIG did, in fact, have a basis for excluding the Petitioners based solely on the claims they submitted within the six-year statute of limitations.
ISSUE #2: Was the 15-year exclusion period reasonable? Therefore, when deciding whether the period of exclusion imposed by the OIG was “reasonable,” the ALJ assessed the following five criteria outlined under 42 C.F.R. §1001.901(b)(1)-(5): [8]

(1) The nature and circumstances surrounding the actions that are the basis for liability, including the period of time over which the acts occurred, the number of acts, whether there is evidence of a pattern and the amount claimed; As the ALJ noted when reviewing the conduct at issue, during the period of time examined by the U.S. District Court, the Petitioners submitted more than 26,000 claims that resulted in more than $10 million in losses to the government. Even if the ALJ limited his review to the relevant conduct during the six-year period covered during this administrative hearing, the Petitioners still submitted 571 improper claims to Medicare. Additionally, despite the Petitioners’ assertions to the contrary, the ALJ found that the Petitioners’ conduct did, in fact, represent a pattern of improper behavior.

(2) The degree of culpability; When considering the Petitioners’ degree of culpability, the ALJ found that the physician owner and the lab were “highly culpable.The ALJ further found that the Petitioners were not victims of careless billing by others. Rather, he ruled that the physician owner was closely involved in the lab’s operations and exercised significant control over the organization’s billing staff. As the ALJ wrote: “There is nothing in the record to suggest Petitioners were simply absentee landlords who had no agency concerning their billing scheme. . . “

(3) Whether the individual or entity has a documented history of criminal, civil or administrative wrongdoing (The lack of any prior record is to be considered neutral);  Although the recent U.S. District Court ruling against the Petitioners for more than $30 million squarely fits within this regulatory factor, the judgment could not have been considered at the time of the exclusion action by the OIG because it had not been rendered at that time. As a result, there was no prior history of wrongdoing that the OIG could have considered. Having said that, there is nothing in the regulation that limits the OIG’s consideration of improper wrongdoing to only actions that have resulted in a judgment. Therefore, the ALJ held that it was proper for the OIG to consider the Petitioners documented conduct when it assessed the 15-year period of exclusion.  

(4) The individual or entity has been the subject of any other adverse action by any Federal, State or local government agency or board, if the adverse action is based on the same set of circumstances that serves as the basis for the imposition of the exclusion; Although the ALJ in this case declined to consider the U.S. District Court ruling as res judicata, the OIG still argued that the ALJ consider the ruling on the False Claims Act constituted an “adverse action.” After considering the positions advanced by the parties, the ALJ held that the requirements set out under 42 C.F.R. §1001.901(b)(4)[9] had not been met, primarily because the ALJ was not persuaded that a ruling by a Federal U.S. District Court could be considered an adverse action by a “agency or board.” Based on this assessment, the ALJ chose not to consider this factor in his analysis of the reasonableness of a “15-year” exclusion.

(5) Other Matters as Justice May Require. Several points were advanced by the Petitioners when addressing this factor. First, Petitioners argued that the Medicare program need no protection from them. Noting that they had improperly billed the Medicare program for millions of dollars, the ALJ concluded that should not be trusted to access program funds. The Petitioners also argued that if they excluded from participation, it would negatively impact patient access to lab care. The ALJ noted that the Petitioners failed to show that there was lack of laboratory facilities in the Houston area. Therefore, Petitioners absence would not negatively impact patients. In fact, the ALJ concluded that the Medicare “will undoubtedly be better off without them.” After considering the evidence, the ALJ found that an exclusion period of 15 years was reasonable in this case. Notably, the ALJ stated that the “circumstances surrounding Petitioners’ billing scheme indicate Petitioners are highly untrustworthy.” The ALJ further found that the mitigating evidence presented by the Petitioners kept the period of exclusion from be much lengthier than the 15-year period of excluded assessed by the OIG.

V. Points Learned from this Exclusion Case: 

Point #1.  Impact of a False Claims Act Judgment. The administrative collateral risks associated with violations of the False Claims Act cannot be underestimated. In this case, where the False Claims Act violations went to trial and resulted in a judgment, the OIG had no reason to waive its permissive exclusion authority. How could this have been avoided? It is important to keep in mind that the vast majority of cases brought by whistleblowers / relators under the civil False Claims Act are not intervened by the government and result in the dismissal of the case. Of the False Claims Act cases that are intervened, most result in a settlement with the government. When settling a False Claims Act case, defense counsel will often seek to wrap-up any outstanding administrative risks (such as exclusion) as well. In order to waive its permissive exclusion authority, the OIG typically requires that health care providers and entities enter into a Corporate Integrity Agreement (CIA) as part of the settlement. In this case, for whatever reason, the False Claims Act case was not settled and went to trial, resulting in a significant judgment and the imposition of a 15-year exclusion.  

Point #2: Issue Preclusion is a Real Possibility. As you will recall, the U.S. District Court in the associated False Claims Act case granted the OIG’s Motion for Summary Judgment. In asserting its arguments in the administrative hearing, the OIG urged the ALJ to narrowly apply estoppel and rely on the District Court’s finding that the claims submitted by the Petitioners were false. The ALJ cited several reasons for not adopting the District Court’s holding in this regard. Nevertheless, it isn’t much of a stretch to imagine a slightly different set of facts, where issue preclusion may have been granted. For instance, if the judgment was final and the time period of the claims at issue were the same, the ALJ may have been persuaded to apply estoppel in this case.

Point #3: ALJs will Give Broad Deference to the OIG When Assessing the Reasonableness of an Exclusion Action. It is important to remember that when making this type of determination, an ALJ is limited to a significant extent and cannot substitute his judgment for that of the OIG. Instead, the ALJ can only consider whether the period of exclusion was within a “reasonable range.”[10] As discussed in the Federal Register more than 25 years ago:

The OIG’s broad discretion is also reflected in the language of § 1001.2007(a)(2), restricting the ALI’s authority to review the length of an exclusion imposed by the OIG. Under that section, the ALI’s authority is limited to reviewing whether the length is unreasonable. So long as the amount of time chosen by the OIG is within a reasonable range, based on demonstrated criteria, the ALI has no authority to change it under this rule. We believe that the deference § 1001.2007(a)(2) grants to the OIG is appropriate, given the OIG’s vast experience in implementing exclusions under these authorities.[11]

VI. Conclusion: 

This case illustrates the collateral impact of a False Claims Act judgment on the participation status of a health care provider. While the judgment itself is serious, being excluded from participation in federal health care programs is as serious, if not more serious, than the judgment. As excluded parties, the physician owner and the lab are effectively out of business. Moreover, the physician owner may find it difficult to obtain employment from another provider due to his exclusion status. Unfortunately, there is a very real chance that these actions are merely the proverbial “tip of the iceberg” in terms of what lies ahead for the physician owner and the lab. The exclusion action qualifies as an adverse action and will be reported to the National Practitioner Databank (if it has not already been reported). Additionally, to the extent that the physician owner and the lab are participating providers in any private payor insurance programs, it is very likely that they have an affirmative obligation to notify the plans of both the False Claims Act judgment and the exclusion action (depending on how their participation agreement is worded). This can result in both private payor audits of similar claims and in termination of a provider’s participation in the payor’s plan.  
How should you react if faced with a similar situation? Contact your health lawyer and make sure that you are prepared to address the various collateral administrative adverse actions that may flow from a False Claims Act judgment and / or an being excluded from participation in federal health care programs. Considering your options at the initiation of a False Claims Act investigation may help you avoid some of the consequences discussed above.

 

OIG ExclusionRobert W. Liles serves as Managing Partner at the health law firm, Liles Parker, Attorneys and Counselors at Law. Liles Parker attorneys represent health care providers and suppliers around the country in connection with UPIC audits, ZPIC audits, OIG investigations and Medicare exclusion actions. Is your practice facing alleged violations of the False Claims Act? We can help. For a free initial consultation regarding your situation, call Robert at: 1 (800) 475-1906.

 

[1] Under the qui tam provisions of the False Claims Act, whistleblowers can are entitled to receive 15% to 25% of any recovery if the United States intervenes in the case, or 25% to 30% if the government declines to intervene in the case that the whistleblower has brought. Defendants who violate the civil False Claims Act are liable for three times the government’s damages plus significant civil penalties for each false claim that was improperly submitted for payment.

[2] Section 1128(b)(7) of the Social Security Act

[3] ALJ decision, citing Petitioner’s Request for Hearing, Ex. A at 2.

[4] In those cases where the OIG concludes that exclusion is not necessary in order to protect the integrity of the Medicare program, it will typically require that the individual and / or entity enter into a Corporate Integrity Agreement (CIA). The purpose of the CIA is to strengthen the provider’s compliance program and reduce the level of risk to the Medicare program.

[5] Under 42 U.S.C. §1320a-7(b)(f), “Federal health care program” is defined as:

(1) any plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government (other than the health insurance program under Chapter 89 of Title 5); or

(2) any State health care program, as defined in section 1320a-7(h).

[6] The Secretary has delegated the authority to impose an exclusion to the OIG, pursuant to: 42 C.F.R. §1001.901(a).

[7] 42 C.F.R. §1001.901(b)(1)-(5).

[8] An abbreviated set of these five criteria were set out in the OIG’s Final Rule, ”Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General’s Civil Monetary Penalty Rule.” See 81 Fed. Reg. 88,334 (Dec. 7, 2016). The full regulatory language of 42 C.F.R. §1001.901(b)(1)-(5) reads as follows:

“(b) Length of exclusion. In determining the length of an exclusion imposed in accordance with this section, the OIG will consider the following factors—

(1) The nature and circumstances surrounding the actions that are the basis for liability, including the period of time over which the acts occurred, the number of acts, whether there is evidence of a pattern and the amount claimed;

(2) The degree of culpability;

(3) Whether the individual or entity has a documented history of criminal, civil or administrative wrongdoing (The lack of any prior record is to be considered neutral);

(4) The individual or entity has been the subject of any other adverse action by any Federal, State or local government agency or board, if the adverse action is based on the same set of circumstances that serves as the basis for the imposition of the exclusion; or

(5) Other matters as justice may require.”

[9] Under 42 C.F.R. §1001.901(b)(4), an “individual or entity has been the subject of any other adverse action by any Federal, State or local government agency or board, if the adverse action is based on the same set of circumstances that serves as the basis for the imposition of the exclusion.”

[10] Craig Richard Wilder, DAB No. 2416 at 8.

[11] Federal Register Final Rule, “Health Care Programs; Fraud and Abuse; Amendments to OIG Exclusion and CMP Authorities Resulting from Public Law 100-93. 57 Fed. Reg. 3298, 3321 (January 29, 1992).

Health Care Providers Should Consider the Ramifications of “Taking a Plea” in a Criminal Case or Agreeing to a Licensure Action. It May Trigger a Mandatory or Permissive OIG Exclusion Action.

(July 16, 2018):  Perhaps the most severe administrative sanction available under the Social Security Act stems from the authority of the Secretary for the Department of Health and Human Services (HHS) to exclude individuals and entities from participating in Federal and State health benefits programs.[1]  The Secretary has delegated[2] this authority to the HHS, Office of Inspector General (OIG)[3]. As a recent comprehensive, first-of-its-kind study by ExclusionScreening.com found that during the period 2013 to 2017, approximately 90% of the permissive OIG exclusion actions taken were based on an adverse administrative action taken against a healthcare provider’s license.  This article examines a decision issued earlier this year by the HHS Departmental Appeals Board (DAB or Board) where the Board examined a licensure-related exclusion action in considerable detail.  

 I.  Brief Overview of OIG Licensure-Related Exclusion Actions: 

With the passage of the Medicare-Medicaid Anti-Fraud and Abuse Amendments[4] in 1977, mandatory OIG exclusion became mandated in cases where a physician and other practitioner has been convicted of program-related crimes. (now codified at section 1128 of the Social Security Act).  Since that time, various additional bases for both mandatory[5] and permissive[6] exclusion have been enacted. Collectively assessed, the most frequent statutory basis relied on by the OIG when seeking to exclude an individual from participation in Federal and State health care programs is “42 USC §1320a-7(b)(4) License Revocation or Suspension.[7]”  As this provision set out:

“Any individual or entity—
(A) whose license to provide health care has been revoked or suspended by any State licensing authority, or who otherwise lost such a license or the right to apply for or renew such a license, for reasons bearing on the individual’s or entity’s professional competence, professional performance, or financial integrity, or
 
(B) who surrendered such a license while a formal disciplinary proceeding was pending before such an authority and the proceeding concerned the individual’s or entity’s professional competence, professional performance, or financial integrity.”

   OIG Exclusion Check

 II.  Case Study: DAB ALJ Decision No. CR4985
[8]; DAB Appellate Div. Decision #2848.[9] 

In this case, a Virginia-licensed Chiropractor pled guilty in 2016 to one count of manufacturing marijuana, a felony. He was sentenced by the Court to 5 years of incarceration (4 years and 11 months suspended) and ordered him to pay a $2,500.  Based on this felony conviction, the Virginia Board of Medicine suspended the individual’s license to practice chiropractic indefinitely.[10]
  • The OIG excluded the individual under 42 USC §1320a-7(b)(4).
The OIG based its exclusion on the indefinite suspension, which links reinstatement to the term of the licensure suspension. The OIG cited 42 USC §1320a-7(b)(4) as its basis for exclusion. 
  • ALJ review of the OIG’s exclusion action.
The Chiropractor (Petitioner) subsequently filed a timely request for review by an Administrative Law Judge (ALJ).  Both the OIG and the Petitioner subsequently filed arguments and related documentation in support of their position.  Notably, the Petitioner’s submissions included (but were not limited to) a copy of his North Carolina chiropractic license and certificates showing his successful completion of chiropractic training courses.  As the ALJ’s decision reflects, after the record had closed, the Petitioner submitted additional documentation, including a letter attesting to his competence and a copy of his active North Carolina chiropractic license.  The ALJ refused to admit the additional materials into record based on the fact that were not submitted in a timely fashion and were irrelevant.  
Further complicating the case was the fact while the matter was pending before the ALJ, the OIG issued a second exclusion notice, advising the Petitioner that pursuant to section 1128(a)(4) of the Social Security Act (as codified at 42 USC §1320a-7(a)(4)), he was being mandatorily excluded from program participation for five years. As set out under 42 USC §1320a-7(a) Mandatory exclusion

 
“The Secretary shall exclude the following individuals and entities from participation in any Federal health care program (as defined in section 1320a-7b(f) of this title). . . ”
Since this mandatory exclusion action was based on the Petitioner’s felony conviction of a criminal offense related to the manufacture, distribution, prescription, or dispensing of a controlled substance, it fell under the following exclusion provision:
 
“(4) Felony conviction relating to controlled substances:
 
Any individual or entity that has been convicted for an offense which occurred after August 21, 1996, under Federal or State law, of a criminal offense consisting of a felony relating to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance.”

Notably the Petitioner does not appear to have appealed the five-year exclusion action. 
Upon consideration of the facts and the evidence, the ALJ sustained the OIG’s decision to exclude the Petitioner from participating in Medicare, Medicaid, and other federal health care programs.
  • Appellate review of the ALJ’s decision.
The Petitioner appealed the ALJ’s decision sustaining the OIG’s decision to exclude him from participation in Medicare, Medicaid and all Federal health care programs. As the ALJ’s ruling reflects, the Petitioner was to be excluded as least until he regained his Virginia chiropractic license. On appeal, the Petitioner raised several issues that were addressed by the Appellate Board:

Petitioner Issue #1:  First, the Petitioner argued that the time frame for exclusion was not adequately addressed by the judge.  The Petitioner further stated that he “did not agree with the length of exclusion because it was excessive and unjust.”

Board Response to #1: As the Board noted in its appellate ruling, in situations where the OIG has excluded an individual’s health care license is revoked or suspended for reasons bearing on the individual’s professional competence, professional performance or financial integrity, the Social Security Act does not delegate an ALJ the discretion to set the length of the exclusion for less than the period during which the individual’s license is suspended. (See, Social Security Act Act § 1128(c)(3)(E); 42 C.F.R. § 1001.501(b)). 

Petitioner Issue #2:  Petitioner argued that the ALJ failed to consider letters from patients and colleagues attesting to the Petitioner’s professional competence and good character in support of a reduction in the length of Petitioner’s exclusion.
 
Board Response to #2: As the Board noted in its decision, neither it nor the ALJ has the authority to consider the letters from the Petitioner’s patients and colleagues attesting to his professional competence and good character for the purpose of reducing the length of Petitioner’s exclusion.  Simply put, equitable arguments and evidence submitted in an effort to obtain a reduction in the length of exclusion cannot be considered.

Petitioner Issue #3:  The Petitioner’s appeal also raised the imposition of a second and separate OIG five-year exclusion action (based on 1128(a)(4) of the Social Security Act; 42 USC §1320a-7(a)) that was imposed while the Petitioner’s appeal was pending before the ALJ.  In the Board proceeding, the Petitioner argued that he was “appealing the five-year exclusion because it is excessive and unreasonable in [his] case.”  He further stated that he was “requesting that [his] exclusion remain as originally reported: three years or until I regain my Virginia license because that would support my position for Inclusion.”

Board Response to #3:  As the Board noted in its decision, the Petitioner only appealed the initial permissive exclusion action under 1128(b)(4), 42 USC §1320a-7(b)(4).  There was no evidence that the Petitioner had requested an ALJ hearing to contest the OIG’s second exclusion action brought under 1128(a)(4) of the Social Security Act; 42 USC §1320a-7(a).  As a result, the Board could not consider the second exclusion action.
  • Lessons to be learned from this case.
Both the ALJ and Board decisions in this case really highlight the lack of discretion that these adjudicators have when it comes to “adjusting” or “reducing” a health care provider’s length of exclusion for less than the period during which the individual’s license is suspended.  As the case noted, the Petitioner was also licensed in North Carolina, and presumably there were no restrictions on his North Carolina.[11]  Unfortunately, the fact that the Petitioner was fully licensed in North Carolina was irrelevant to the decisions of both the ALJ and the Board.  As 42 C.F.R. § 1001.501(b) expressly provides: 

“(b)Length of exclusion.
(1) Except as provided in paragraph (b)(2) of this section, an exclusion imposed in accordance with this section will not be for a period of time less than the period during which an individual’s or entity’s license is revoked, suspended, or otherwise not in effect as a result of, or in connection with, a State licensing agency action.  (Emphasis Added).

So, what should a health care provider do if he or she receives notice that the OIG is seeking to exclude him or her based on a licensure suspension action?  It is important to keep in mind that a licensure-based exclusion action is a permissive action that may or may not be pursued by the OIG.  To the extent that there is any chance to convince the OIG that the agency should decline to exercise it permissive exclusion authority, now is the time for your legal counsel to make its pitch.

Once the OIG has formally exercised its permissive exclusion authority, the restrictions set forth under 42 C.F.R. § 1001.501(b) must be applied.  Neither an ALJ nor the Board has the discretion to deviate from the time period requirements imposed by statute.  Although the OIG rarely waives its discretion to pursue a permissive licensure-based exclusion action, providers should.

This case also serves as a stark reminder that neither an ALJ nor the Board is in a position to “weigh” the equities in a licensure-based exclusion case when assessing the length of time imposed for the exclusion.  Adjudicators are required by statute to determine whether an exclusion determination made by the OIG was consistent with the law.  Equitable arguments and evidence such as those submitted by the Petitioner in this case cannot be considered in a licensure-based exclusion case.  An individual cannot have an exclusion lifted until his or her license is reinstated.  Period. 

In recent years, the number of exclusion actions imposed by the OIG has continued to grow. While there is little or no flexibility with respect to some of the bases for exclusion, every case is based on a unique set of facts, some of which may present opportunities to negotiate a more favorable period of exclusion with OIG, or even avoid exclusion all together. 

We strongly recommend that you contact experienced health law counsel at the first sign that you may be excluded from participation in Federal and State health care programs.  In terms of strategy, a health care provider’s best course of action is to engage experienced health law counsel at the earliest opportunity, preferably before an adverse action has been taken against your professional license.  A comprehensive response strategy is essential so that you possible minimize the adverse collateral effects of an adverse licensure action.  The attorneys at Liles Parker have extensive experience representing health care providers in exclusion-related proceedings. 


OIG ExclusionRobert W. Liles serves as Managing Partner at the health law firm, Liles Parker, Attorneys and Counselors at Law.  Liles Parker attorneys represent health care providers and suppliers around the country in connection with UPIC audits, OIG exclusion actions and state licensure board disciplinary proceedings.  Has an exclusion action been proposed against your license?  We can help.  For a free initial consultation regarding your situation, call Robert at:  1 (800) 475-1906.

[1] The term “Federal health care programs” is defined under Section 1128B(f) of the Social Security Act as:
(1) any plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government (other than the health insurance program under chapter 89 of title 5, United States Code); or
(2) any State health care program, as defined in section 1128(h).
42 U.S.C. § 1320a-7b(f) (2012).
[2]See Updated: Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs, U.S. Dep’t of Health & Human Servs.: Office of Inspector Gen., at 2-3 (May 8, 2013) (stating that . . . the Secretary has delegated authority to OIG to exclude from participation in Medicare, Medicaid, and other Federal health care programs persons that have engaged in fraud or abuse and to impose civil money penalties (CMPs) for certain misconduct related to Federal health care programs”).
[3] The OIG maintains a website containing up-to-date information on federal health care program exclusion rules, which can be found at http://oig.hhs.gov/fraud/exclusions.asp.
[4] While Public Law 95-142’s “exclusion” provisions are important, the legislation is best known for its impact on the Federal Anti-Kickback Statute.  More specifically, the legislation made violations of the Federal Anti-Kickback Statute a felony. It also made those who offered remuneration for referrals and those who received them, subject to various penalties.
[5] Under the government’s mandatory exclusion authority (as set out under Section 1128(a) of the Social Security Act), any individual or entity convicted of certain offenses must be excluded from participation in federal health care programs.  The length of a mandatory exclusion action taken can last a minimum of five years.
[6] Depending on the circumstances, OIG may also exercise “permissive” or discretionary authority to exclude an entity or an individual from participation in federal health care programs.
[7] Under 42 USC §1320a-7(b)(4), any individual or entity whose professional license to provide health care has been revoked or suspended, or has lost the right to apply for a license, CAN be excluded from participation, at OIG’s options.
[8] DAB ALJ Decision No. CR4985, dated December 13, 2017.
[9] DAB Appellate Div. Decision No. 2848, dated February 6, 2018.
[10] Under the Virginia Code, the Board of Medicine may suspend a license indefinitely for “acts of unprofessional conduct,” which include “knowingly and willfully” committing a felony; violating any statute or regulation relating to the manufacture, distribution, dispensing, or administration of drugs; and conviction of a felony.  See Virginia Code §§ 54.1-2915(A)(10), (17), and (20).
[11] This is an interesting point raised by the Petitioner. In some states, the revocation of a professional license is permanent and can only be reinstated upon the submission of a new application.  Even then the state board has the discretion of whether or not to consider the new application.  Theoretically, a health care provider could be licensed in 49 states and still be excluded due to a suspension action in the 50th state.
As an aside, the public record does not address whether North Carolina, like many states, normally imposes reciprocal disciplinary actions based on those taken in other jurisdictions.
1 2 3