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.”

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.

Dental OIG Exclusions – A Review of 2017 Actions.

Dental OIG exclusion(January 12, 2018):  The Medicare and Medicaid programs are both essential, yet costly health benefit programs sponsored in whole or in part by the Federal government.  With Medicare and Medicaid costing $686 and $368 billion each year, respectively, the government has dedicated experienced investigators, auditors and prosecutors to ferret out incidents of health care fraud and abuse. While most health care fraud administrative, civil and / or criminal cases are brought against medical providers, dental providers and the members of their staff are increasingly finding that their actions are under scrutiny by Federal and State regulators. A prime example is illustrated by the various “dental OIG exclusion” actions taken against dentists and dentist office staff last year during 2017.[1] 

I. What is an “Exclusion” Action?

Simply put, under certain circumstances, the Department of Health and Human Services, Office of Inspector General, Office of Inspector General (HHS-OIG) is mandated by law to exclude” individuals and entities from participating in Federally funded health care program under 1128 of the Social Security Act (SSA),[2] and from Medicare and State health care programs under section 1156 of the SSA. Under other circumstances, HHS-OIG exercises the discretionary authority to decide whether or not to exclude a party.

During 2017, HHS-OIG took a number of administrative exclusions actions against dentists and dental practice personnel in order to meet their statutory obligations.  As set out below, a brief description of the exclusion actions taken against dental professionals, along the frequency of their occurrence are described in the section below.

II.  Exclusion Actions Taken Against Dentists and Dental Staff in 2017:

With the exception of the permanent revocation of one’s professional license, there is perhaps no administrative sanction that may be taken against a health care provider that is more serious than an exclusion action.  As we will discuss later in this article, the collateral impact of an exclusion action can be financially devastating to your dental practice.  In any event, there are a number of mandatory and permissive bases upon which HHS-OIG can base an exclusion action.  Depending on the reason for exclusion, an individual or entity can be excluded from an undetermined minimum period up to a permanent exclusion from participating in Federal health benefits programs.

Dentists and dental staff members are subject to exclusion and are regularly sanctioned by HHS-OIG.  During 2017, a handful of dental professionals were placed on HHS-OIG’s exclusion list most months but the reasons for exclusion were primarily grouped into the categories for exclusion described below:

42 U.S.C. §1320a-7(b)(14): Default on health education loan or scholarship obligations.  50% of all exclusions against dentists / dental staff. The largest group of dentists and dental office personnel excluded by HHS-OIG in 2017 were sanctioned on the basis of their default of one or more Federally-secured health education loans. Approximately 53.13% of the dental professionals and staff were excluded on this basis.  This is especially noteworthy when you consider the fact that only 2.38% of the total number of health care providers and other individuals excluded by HHS-OIG in 2017 were on the basis of a similar loan default.  Although it is never a “good” thing to be excluded from participating in Federal health benefits programs, health care providers who are excluded under this this provision are eligible to apply for reinstatement as soon as they resolve they resolve their loan default with the Federal government.  In the overall exclusion scheme, this is by far the most benign of all exclusion authorities. 

42 U.S.C. § 1320a-7(a)(1): Conviction of program-related crimes. 18.75% of all exclusions against dentists / dental staff.  This mandatory exclusion provision was the second most frequent basis cited by HHS-OIG when sanctioning dentists and dental staff in 2017.  As an example, in one case, a Charleston, WV dentist admitted that he improperly engaged in upcoding with respect to at least 7,490 tooth extractions.  These extractions led to more than $1.3 million in billings. He further admitted that if those extractions were medically necessary, and if had actually performed the procedures he claimed, then he should have been paid only $599,200.  He next admitted that he submitted other false bills and improperly received payment.  As part of his plea agreement, the dentist agreed to pay $738,067 in restitution.  He also entered into a separate civil settlement agreed to be excluded from participation in the Medicare and Medicaid programs for 13 years.  Notably, across the board, among all health care providers and individuals, 42 U.S.C. § 1320a-7(a)(1) was used as a basis for excluding individuals, in 39.09% of all cases.  In contrast, it was only cited in 18.75% of the cases involving dentists and dental staff.

42 U.S.C. § 1320a-7(a)(3):  Felony conviction relating to health care fraud. 3.13% of all exclusions against dentists / dental staff.  This mandatory exclusion provision requires that HHS-OIG exclude an individual who is convicted of felony health care fraud for a minimum of 5 years.  In one 2017 case citing this basis for exclusion, a long-time claims manager in a dental practice went to the State Dental Board to complain that the dentist for whom she worked was engaging in fraud.  She alleged that he was billing Delta Health Systems[3] for dental services not rendered, performing medically-unnecessary dental services and offering cash and noncash incentives to his staff to make appointments. The claims manager was then implicated in the wrongdoing and both the dentist and the claims manager were charged with Federal crimes. The claims manager was subsequently sentenced to 21 months in prison and the dentist for whom she worked was sentenced to three years, 10 months in prison.  Both defendants were ordered to jointly pay $726,300 in restitution.  3.13% of the exclusion actions against dentists and dental staff were on the basis of 42 U.S.C. § 1320a-7(a)(3).  Similarly, 7.68% of the exclusion actions taken against all health care providers by HHS-OIG were on this basis. 

42 U.S.C. § 1320a-7(b)(4): License revocation, suspension, or surrender. 12.50% of all exclusions against dentists / dental staff.  Under this basis for permissive exclusion, HHS-OIG may choose to exclude a provider if the provider’s license is revoked, suspended or surrendered. In one 2017 case, the State of Utah alleged that the one of its licensed dentists had engaged in unprofessional conduct.  The conduct supposedly included using controlled substances from prescriptions written to family members, treating family members for opioid addiction without being trained to do so, having a conviction for impaired driving and providing false information on an application.  The dentist’s licenses were revoked, the revocations were stayed and the dentist’s licenses were placed on probation for five years. Based on the licensure actions taken, HHS-OIG exercised its permissive exclusion authority under 42 U.S.C. § 1320a-7(b)(4).  Globally, licensure-based exclusion actions constituted 30.81% of the actions taken by HHS-OIG against health care providers and other individuals during 2017.  In contrast, only 12.50% of the exclusion actions against dentists and dental staff were based an underlying licensure disciplinary action.

42 U.S.C. § 1320a-7(a)(4): Felony conviction relating to controlled substance. 6.25% of all exclusions against dentists / dental staff.  This mandatory basis for exclusion was only cited 6.25% of the time by HHS-OIG when sanctioning dentists and dental staff.  Consistent with its finding for dentists, HHS-OIG only based exclusions on this authority 5.63% of the time among all health care providers (and other individuals) during 2017.  In one of the cases we reviewed, a South Dakota dentist pleaded guilty to a charge of “Obtaining Possession of Controlled Substance by Fraud or Deception,” a Class 4 Felony.  In light of the plea, HHS-OIG was required by law to exclude the dentist from participation in Federal health benefits program for a minimum of 5 years.[4]  

Two other bases for exclusion, 42 U.S.C. § 1320a-7(b)(3): Misdemeanor conviction relating to controlled substance, and 42 U.S.C. § 1128b7:  Fraud, kickbacks, and other prohibited activities, were infrequently cited by HHS-OIG in connection with exclusion actions it took against dentists during 2017.  None of the other mandatory or permissive exclusion authorities were relied upon by HHS-OIG when sanctioning dentists and / or dental personnel during 2017.

III.  Impact of Exclusion on Dentists and Dental Staff:

Former Federal prosecutor and the current Compliance Officer for Exclusion Screening, Paul Weidenfeld, best described the impact of an exclusion action when he stated:

“If an individual is excluded from participating in Federal health benefits programs, for all practical purposes, they are likely unemployable by anyone who accepts insurance from Medicare, Medicaid, TriCare, FEHBP or another health benefit program that is funded in whole or in part by Federal funds. Moreover, each year we are seeing more and more private payors insist that their participating providers screen out any excluded employees, contractors, vendors and agents.
Ultimately, this is a matter of RISK.  You must screen your staff, vendors, agents and contractors every 30 days.  The last thing you want is to have a staff member with either a suspended / revoked license or a felony conviction for fraud or patient abuse working in your practice without your express knowledge.”

A. Are Your Lax Practices Exposing You to CMPs?

In 1981, Congress enacted the Civil Monetary Penalties (CMP) law, Public Law 97-35 codified at section 1128A of the Social Security Act).  Under this statute, HHS-OIG was authorized to impose CMPs against any individual or entity found to have submitted claims for payment by Medicare or Medicaid for items or services furnished by an excluded individual.  Since first being passed, there have been several additional statutes further expanding HHS-OIG’s authority to assess CMPs.  As it now stands, if a health care provider fails to properly screen to ensure that no excluded individuals are employed, virtually every claim that an excluded individual is associated with will be regarded as “tainted” and will be subject to CMPs.

B. Don’t Judge a Book by Its Cover – Screen All Applicants Before Bringing on New Hires.

Merely asking an applicant on their application if they are currently excluded from Medicare or Medicaid (or have ever been excluded from Medicare or Medicaid) is totally insufficient.  After filling out one or two applications for employment, individuals who have been excluded are savvy enough to realize that anytime they check the box “YES,” they will not even qualify for an interview.  As a result, over the last year, our Firm has handled several voluntary disclosure matters where an applicant lied about his exclusion status in order to get a job.  Six to a year later, the provider learned that the new employee was excluded and had been excluded when initially hired at the practice.  The lesson to be learned is simple – you cannot rely on any assertions made by an applicant regarding the applicant’s exclusion status.  You need to verify it yourself, prior to onboarding a new hire.

C. Exclusions are Not Restricted to Merely Licensed Professionals:

The impact of an exclusion action on a health care provider’s ability to conduct business can be significant.  Moreover, the severe consequences of exclusion have been a constant warning of HHS-OIG since it first published its Special Advisory Bulletin in 1999 entitled “The Effect of Exclusion From Participation in Federal Health Care Programs. 
Importantly, virtually anyone can be excluded from participation Federal health care programs.  Moreover, the adverse impact of an exclusion action is not merely limited to licensed individuals such as dentists, oral surgeons and / or dental hygienists.  Non-clinical staff who furnish administrative and management services that are payable by the Federal health care programs are also affected by an exclusion action and can expose your dental practice to liability.  As HHS-OIG’s “Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs” goes on to further clarify:
“. . . an excluded individual may not provide other types of administrative and management services, such as health information technology services and support, strategic planning, billing and accounting, staff training, and human resources, unless wholly unrelated to Federal health care programs.”

D. Exclusion Actions are Reported to the NPDB:

If an individual is excluded from participation in Federal health care benefits programs, HHS-OIG considers the matter to be a reportable event and will report the administrative sanction to the National Practitioner Databank (NPDB) for inclusion in its system.  As a result, all payors (both public and private), will be notified of the adverse action.   Since most dental practices participate in at least one dental insurance program, you are likely required to notify the payor of any adverse actions brought against you within 30 – 60 days of the event (the time to report varies from contract to contract).  Dentists placed in this position often find it difficult to effectively respond to private payor inquiries regarding an exclusion order.  If the dentist notifies a payor immediately after being excluded, most payors will initiate their own administrative review of the facts to determine whether they want to continue to allow the provider to continue work as a participating provider.  If a dentist fails to notify the payor of the exclusion action within the 30-60 day deadline imposed under the parties’ contract, a payor will typically initiate a termination action based on the provider’s breach of its contractual obligations.

IV.  The Solution – Reducing Your Level of Risk:

To reduce your level of risk, a dental provider should screen its applicants, clinical staff, administrative staff, contractors, vendors and agents on a monthly basis.  At the time of the writing of this article, there a total of 40 different databases that need to be checked.  These 40 databases include:

(1) List of Excluded Individuals and Entities (LEIE). Maintained by HHS-OIG.
(2) System for Award Management (SAM). Maintained by the General Services Administration.
(3) 38 State Medicaid Exclusion Registries. Maintained by either the State Attorney General’s Office or the State Medicaid Fraud Control Unit (MFCU).

Neither the Federal nor the State governments currently maintain a “consolidated” database that incorporates all of the Medicare and Medicaid exclusion actions into a single records system that can easily be checked by providers.   From a practical standpoint, it is rarely cost-effective for a provider to check all 40 databases on an individual basis.  Therefore, we strongly recommend that you utilize the services of an organization such as www.exclusionscreening.com.  Their services are inexpensive yet comprehensive.   

V.  Conclusion:

The implementation of an effective screening program is perhaps the least expensive step you can take to help bring your dental practice into at least partial compliance.  Although, it won’t satisfy all of your obligations as a health care provider, it is a significant step in the right direction and can greatly reduce your level of overall risk.  We therefore strongly recommend that you fully comply with the recommendations of HHS-OIG and screen your employees, contractors, agents and vendors every 30 days.  If handling this task is too burdensome to complete in-house, use the services of a company like Exclusion Screening.  


Healthcare AttorneyRobert W. Liles, J.D., M.B.A., M.S., serves as Managing Partner at Liles Parker, PLLCLiles Parker is a health law firm representing dentists and dental practices around the country in connection with Medicare, Medicaid and private payor audits.  We also represent dentists in State Dental Board disciplinary actions.  For a complimentary consultation, give Robert a call at: (202) 298-8750.


[1] Please keep in mind, the List of Excluded Individuals and Entities (LEIE) that is maintained by HHS-OIG only includes Medicare exclusion actions and other exclusion actions that have been reported to it by one of the states.  Despite their obligation to do so, many states do not report all or some of the exclusion actions they have taken against health care providers, individuals and entities.  For a complete analysis of the exclusion actions taken against dentists and dental staff in 2017, a review of each of the state exclusion actions taken must also be conducted.

[2] Under the provisions of the 1977 Medicare-Medicaid Anti-Fraud and Abuse Amendments, Public Law 95-142 (now codified at Section 1128 of the Social Security Act), physicians and other practitioners convicted of program-related crimes were first excluded from participation in the Medicare and Medicaid programs.
[3] In this case, Delta Health Systems was the program administrator for United Parcel Service Inc. (UPS) employees.
[4] It is also worth noting that in a case where a pharmacist entered into an agreement to plead guilty if the state would not oppose a “deferred judgment,” HHS-OIG still took the position that it was appropriate to exclude the pharmacist from participation from participation in Federal health benefits programs. Unfortunately, the author does not give a citation for the case. HHS-OIG may have exercised its exclusion authority under one of the applicable permissive exclusion provisions.   

Health Care Fraud to Remain a DOJ Priority

Exclusion News (May 22, 2017):
By Paul Weidenfeld

Health Care Fraud will continue to be a high priority of the Department of Justice Kenneth Blanco, the Acting Head of the Criminal Division.  Describing health care fraud as “egregious,” “despicable” and driven by “greed” – Mr. Blanco, told the iABA Health Care Fraud Institute last week. went on to say that the department would be “vigorous” in its pursuit of those who violate the law in this area.”

Department of Justice announcements of its commitment to health care fraud enforcement are common and would hardly have been noticed in prior administrations. But by going out of his way to “be clear” that health care fraud is “something that Attorney General Sessions feels very strongly about” and remains a “priority” for DOJ, Mr. Blanco appears to be sending the message that health care fraud had not been left behind in a Justice Department that has been pursuing several new initiatives and has several new areas of focus. 

A Concern that Health Care Fraud Deprives Care to the those in Need

While patient safety and financial costs have been the longstanding focus of health care fraud enforcement, Mr. Blanco told the conference attendees that money stolen is “important,” but that his focus was on the impact that health care fraud has by denying services to those in need. In his view, health care fraud “deprives many people of access to medical care, even the most basic forms of care, because fraud increases the costs for all of us and shuts out those who are the most needy or those in society who are just making it.”

The assertion that there is a direct linkage between health care fraud and the deprivation of services to certain specific segments of the population appears to stake out new ground in the fight against health care fraud. It will be interesting to see if this slight shift in concerns results in any change in health care fraud enforcement policies or investigation goals.

Data Mining and Information Sharing Driving Enforcement

Mr. Blanco also discussed recent investigations and stressed that the “cooperative partnerships” between the criminal division strike force, the investigative agencies and the U.S. Attorney’s Offices were critical to the recent enforcement successes. To this point, he noted that last years “national health care fraud takedown” involved 36 separate U.S. Attorney’s Offices and many State Medicaid Fraud Control Units while resulting in charges against 301 individuals and alleged false billings in the amount of $900 million.

The wide array of investigative and prosecutorial tools at the divisions disposal and the advanced data mining techniques being employed were also credited. As Mr. Blanco stated, “We now have an in-house data analytics team headed by some of the best and brightest. Analyzing billing data from CMS has become a key part of our investigations because it permits us to focus on the most aggravated cases and to identify quickly emerging schemes and new types of Medicare fraud…We have the opportunity to halt schemes as they develop. This cutting-edge method has truly revolutionized how we investigate and prosecute health care fraud.”

Final Thoughts 

The Justice Department may have new leadership, new interests and new initiatives, but last week appears to be intended to send a “clear” message that it’s interest and focus on health care fraud will remain strong under Mr. Sessions.  It will be interesting, however, to keep an eye on whether there is a “shift” in focus to a consideration of the impact of fraud upon the long term availability of services; and if so, what form that shift might take in terms of future cases or initiatives.


The New “Seventh Element” of Compliance: Screening and Evaluating Employee Suitability!

Co-Founder, Exclusion ScreeningThe recently issued Resource Guide for Measuring Compliance Program Effectiveness, reconfigures the traditional formulation of the “Seven Elements of an Effective Compliance Program by making the “Screening and Evaluation of Employees, Physicians, Vendors and other Agents” an element unto itself – or the new “Seventh Element of Compliance!” The Resource Guide, a product of roundtable discussions by staff members of the Office of Inspector General and compliance professionals and prepared under the auspices of the Health Care Compliance Association (HCCA), serves to once again underscore the critical role of exclusion screening and background checks in compliance

The Importance of the Hiring Process in Health Care

Employee suitability is critically important in healthcare because most of a provider’s operational costs, and almost all of his risks, are directly related to his employees. Whereas most industries are trying to respond to a wide range of risks over which they have little or no forewarning or control (for example, the impact of weather, the availability of supplies or critical equipment, or the failure of equipment they neither own or operate), the majority of risks to health care providers are mostly known and directly related to employee conduct or misconduct (medical malpractice, patient safety, financial fraud, drug diversion, regulatory violations, data and record security, etc.)

The hiring process in healthcare also important because of the value that employees can provide for an organization. “Good” employees enhance the value of organizations; they perceive potential risk and report or fix it, they provide important modeling for new employees, they care for patients in a way that engenders loyalty, they pitch-in, they are honest and show up for work! And so on. Thus, while employees are often the source of loss and cost – they can also represent a sustainable resource that gives an organization a competitive advantage. Viewed in this context, the importance of the hiring process and determining the suitability of employees to a provider’s compliance program becomes clearer still.

Exclusion Screening and Background Checks

An important aspect of determining an applicants overall suitability is “screening” them with Federal and State Exclusion and Sanction Lists. The Resource Guide holds forth that screening should be accomplished upon hire and monthly thereafter, and the importance of thorough screening cannot be overstated as most exclusions are imposed as a result of conduct connected to fraud, patient abuse or neglect, or the sale or abuse of drugs or fraud. Further, regardless of “why” an OIG Exclusion is imposed, persons or entities excluded from Federal Health Care Programs are deemed as a matter of administrative law to “pose unacceptable risks to patient safety and/or to the financial integrity of government programs.”

Exclusion Violation Enforcement

Federal Health Care Programs will not pay for any items or services furnished or provided, directly or indirectly, by an excluded individual or entity. This broad “payment prohibition,” which can extend even to volunteers, renders anyone who is excluded “radioactive“ when it comes to health care. Any claim connected to an excluded person is a potential overpayments, employing or contracting with an excluded person can result in the imposition of civil money penalties, and there have even been False Claims Act cases brought against providers that have used excluded persons.

The OIG signaled that enforcement of exclusion violation was going to be an agency priority in 2013 when it issued its “Updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs” and revised the “Self-Disclosure Protocol.” Since that time, it has created a special unit tasked with exclusion enforcement as a priority and sought to expand its exclusion authority on several occasions.


The risks and benefits associated with the hiring process are significant; a fact emphasized all the more by the addition of “Screening and Evaluation of Employees, Physicians, Vendors and other Agents” as the new 7th Element for Evaluating the Effectiveness of Compliance Plans. Providers are urged to do thorough screening as part of their hiring process and to take all possible actions toward ensuring a positive work force, and to avail themselves of the assistance of reputable vendors to assist them in this process.

About the Author
Paul Weidenfeld is a long time health care lawyer who has specialized in litigation arising out or, or relating to healthcare fraud and the False Claims Act. A former federal prosecutor and National Health Care Fraud Coordinator for the Department of Justice, Paul is a frequent speaker who has earned recognition both as a Federal Prosecutor and as a member of the private bar.  Paul is also a co-founder of Exclusion Screening, LLC, a company that offers providers a simple, cost effective way to meet their exclusion screening obligations.

Pharmacies Targeted for Exclusion Violations by OIG and States

By Catalina Jandorf

OIG Exclusion

In what appears to be a growing enforcement trend, the Department of Health and Human Services, Office of Inspector General (HHS/OIG) and State Medicaid Fraud Units are aggressively pursuing pharmacy retailers for exclusion violations.  In recent investigations, pharmacies are being targeted for failing to screen prescribers as well as employing pharmacists who have been excluded from Federal and State health care programs.  This new focus has resulted in sizable settlement recoveries, and evidences a broadening of the scope of Federal and State exclusion enforcement efforts.

Significant State Exclusion Enforcement Actions

New York Attorney General Eric T. Schneiderman entered into an agreement with a pharmacy in May 2016 to resolve allegations that it had billed Medicaid for prescriptions written by an excluded Medicaid provider.  Between April 2010 and January 2013, the pharmacy submitted and received payment for approximately 4,600 Medicaid claims for prescriptions written by an excluded physician.  Under Medicaid rules, prior to filling a prescription pharmacies are required to first determine whether the prescriber’s services are eligible for reimbursement.  In this case, they had not done so and had filled and delivered prescriptions written by a provider ineligible to receive Medicaid reimbursement.  As a result of the settlement, the pharmacy agreed to pay New York State $442,000 plus $36,000 in damages pursuant to the New York False Claims Act.  In a statement, A.G. Schneiderman says, “My office will continue working to root out Medicaid fraud and recover unlawfully claimed funds, so that Medicaid can continue providing critical services for those in need.”  The Attorney General’s Medicaid Fraud Control Unit (MFCU) investigated, prosecuted, and entered into a resolution independent of any OIG investigation.  The prescriber in this case was excluded under the New York State list first and then under the GSA’s System for Award Management (SAM), but never appeared on the OIG’s List of Excluded Individuals and Entities (LEIE).  This is significant since the State used its own enforcement authority to target this pharmacy and launch its own investigation without any Federal involvement.

However, this is not the first time the States have expressed an interest in pursuing exclusion violations against a pharmacy.  In a prior case from 2011, a large national retail pharmacy entered into a $1 million settlement with the U.S. Attorney’s Office in the District of New Jersey in connection to allegations that it had employed a pharmacist who had been banned from participating in Federal health care programs due to a drug conviction.  The excluded pharmacist had worked at three pharmacy locations in New Jersey and New York for a period of about four years and ending in July 2009.  Prior to his employment, he had been convicted of attempted criminal sale of a controlled substance, and as a result had been excluded from Federal health care programs in September 2005.  Any claims he had submitted while employed by the company were deemed false.  An investigation concluded that the pharmacy was responsible for the amount billed by the excluded individual because it failed to investigate whether he was banned from Federal health programs.  Although the company claims that it maintains a comprehensive pre-employment screening process, it did not follow its own protocols to determine if the conviction excluded the individual from the programs.  If these two cases are any indication, it appears as if the States will be taking more of an initiative in pursuing their own enforcement actions against pharmacies in the future.

Federal Enforcement Efforts Initiated by OIG

The Federal governState Exclusionment has also remained vigilant in cases involving excluded pharmacists.  In August 2016, a Texas pharmacy and pharmacy manager entered into a $30,000 settlement agreement with OIG.  Their investigation reveals that the excluded individual, a store manager and pharmacy technician, had provided items or services that were billed to Federal health care programs.  In another case from January 2015, a Minnesota pharmacist entered into a nearly $100,000 settlement agreement with OIG.  The settlement resolved allegations that from March 2006 to July 2013, the pharmacist owned and managed a pharmacy that participated in Federal health care programs while he was excluded from participating in those programs.

We have previously reported on a case in which OIG entered into a massive settlement with an Ohio-based corporation that operates pharmacies and supermarkets in thirty-four states, in connection to its employment of excluded pharmacists.  In December 2015, the company self-disclosed to Office of Inspector General that they employed and utilized pharmacists who were banned from participation in Federal health care programs.  An investigation confirmed that the company had employed fourteen individuals that were debarred and therefore could not submit claims for items or services they furnished.  In addition to employing excluded pharmacists, the settlement alleges that the company had filled prescriptions from eighty-four excluded providers.  According to OIG’s May 2013 Special Advisory Bulletin, insurance claims for items or services provided by, or at the medical direction of or on the prescription of debarred individuals are not reimbursable.  The company agreed in a civil settlement to pay Federal health care programs $21.5 million in restitution and penalties, and almost $1 million more to the Office of Personnel Management (OPM) for employing individuals who had been debarred from participating in the Federal Employee Health Benefit Program (FEHBP).


These cases highlight some recent trends in enforcement actions against pharmacies that employ excluded pharmacists and fail to properly screen prescribers.  It is evident that both State and Federal entities are interested in pursuing exclusion violations, and have been doing so independent of each other.  Even the most stringent pre-employment background checks can result in omitted excluded individuals, and consequently the pharmacy itself would be liable for submitting false claims.  Pharmacies especially can be susceptible to substantial settlement amounts because of the large volume of prescriptions they handle every day, and since it can be very costly and time-consuming to screen every prescriber.

Screening employees, vendors, and contractors against the LEIE and the SAM, as well as all 38 State lists every month is critical to avoid being found liable of an exclusion violation and consequently having to pay a large settlement amount.  To eliminate the risk of having to self-disclose or undergo a State or Federal investigation, contact the Exclusion Experts at 1-800-294-0952 or online for a free consultation.

OIG Imposes Record Penalties for Exclusion Violations

exclusion violations
OIG Imposes Record $21.5 Million in Penalties for Exclusion Violations!

The OIG imposed a record $21.5 million civil money penalties and restitution against an Ohio corporation that operates pharmacies and supermarkets in 34 states for exclusion violations involving the employment of excluded individuals and fulfilling prescriptions by excluded prescribers! The settlement alleged that the company filled prescriptions from 84 excluded pharmacists and directly employed 14 pharmacists that had been excluded from federal health care programs.

The Office of Personnel Management participated in the investigation through its Office of Inspector General and confirmed that 14 direct employees had been debarred from participating in the Federal Employee Health Benefit Program (FEHBP).  OPM received over $314,000 in penalties and $628,000 in restitution as part of the settlement.

Federal Health Care Programs do not pay for items or services that are provided, either directly or indirectly, by excluded individuals and the Office of Inspector General also has the authority to impose Civil Money Penalties on providers that knowingly submit such claims. Providers that fail to screen on a monthly basis to identify excluded employees or vendors are considered to have knowningly submitted such claims related to such persons or entities.

When the OIG announced last June that it had created a Special Litigation Unit dedicated to enhancing its enforcement of OIG Exclusion Requirements and Civil Money Penalty, it put the provider community on notice of its continuing commitment to enforce exclusion screening requirements and punish exclusion violations. Since that time, it has announced over 50 settlements involving the employment of exclusion individuals including a number of recent large settlements.

OIG Exclusion

Paul Weidenfeld, Co-Founder and CEO of Exclusion Screening, LLC, is the author of this article. He is a longtime health care lawyer whose practice has focused on False Claims Act cases and health care fraud matters generally. Contact Paul should you have any  questions at: pweidenfeld@exclusionscreening.com or 1-800-294-0952.

How Compliance Hotlines Can Save You Money!

Compliance Hotlines

By Paul Weidenfeld, March 4, 2016.  An essential element of all compliance plans is developing and promoting “effective lines of communications.” In support of that element, Health and Human Services Office of Inspector General (HHS/OIG) has been urging providers to adopt anonymous compliance hotlines since 1998. CMS, on the other hand, actually requires that Fee-For-Service Contractors (by its 2005 Guidance), and Managed Care and Prescription Drug Contractors (through manual provisions) have “mechanisms that permits anonymous reporting.”

But many providers, while complying, view hotlines with suspicion. They fear that a “successful” compliance hotline might incentivize “whistleblowers” and ultimately result in additional risk and cost to their organization. Though understandable, this fear is misplaced. Properly implemented and supported, hotlines provide valuable support to compliance plans and overall risk management programs. Rather than increasing risk and costing money, compliance hotlines demonstrably decrease risk and save money. Here’s how:

Tips are the Most Common Means of Detecting Fraud

Fraud accounts for an estimated 10% of healthcare spending (almost $1 Billion in 2013). The best way to reduce fraud’s impact is through early detection and quick resolution. According to a recent report on occupational fraud by the Association of Certified Fraud Examiners (ACFE) “tips” are easily the most common means of detecting fraud. It found that over 40% of all cases were detected by a tip — more than twice the rate of any other detection method – and as the percentage of detections by tip increases, detection by other, external means decrease.

The Importance of Compliance Hotlines in Generating Tips

The ACFE report referred to above also looked at the impact of compliance hotlines on generating tips and it found that companies with compliance hotlines discovered fraud through tips 51% of the time as compared to 33% for companies that didn’t have a hotline. Not surprisingly, the companies without compliance hotlines also had higher rates of detection through other means such as external audits and law enforcement. Several factors are cited for the disparity, but the principle reason is the anonymity and confidentiality afforded by hotlines. Indeed, it was reported that 60% of all employee tips were anonymous.

Why Detection by “Tip” is Important

In addition to being the most common means, tips are the most cost-effective way of detecting fraud by external means. Several factors contribute to this, but the report found a significant difference in results for frauds detected by tips as compared to any other external detection method. For example, the median duration and cost of a fraud discovered by tip was 18 months and $150,000, whereas frauds detected by external audit or by accident lasted at least a year longer and cost over twice as much to resolve. Matters detected by law enforcement, a worst case scenario, lasted 30 months and cost $1,250,000!

Compliance Hotlines Don’t Create “Additional” Problems

It is unrealistic to think that issues identified though a hotline would have “fixed themselves and gone away” or, perhaps, never have been found. More likely, the problem would continue unabated until it was discovered by accident or it was picked up by an audit (hopefully, an internal one), or until an employee who would have reported it lost faith in the organization’s ability to deal with the problem and aired his concerns outside the organization – perhaps to law enforcement, perhaps to a lawyer or maybe to both. Regardless, once a problem reaches that point, it is outside the control of the organization. Thus, any resolution will be a long time coming and expensive when it gets there!


Compliance Hotlines save organizations money. By increasing the number of tips, organizations can learn about more problems. This gives them the ability to respond to them sooner and fix them faster. Therefore, small problems won’t become big ones – and big problems can be managed before they become disasters!

Follow us on twitter to get all the latest news and updates on exclusion and compliance! https://twitter.com/@exscreening/


OIG Exclusion

Paul Weidenfeld is the CEO of Exclusion Screening, LLC and co-founder with Robert W. Liles. Both Paul and Robert are long time health care lawyers and both were also former Health Care Fraud Coordinators for the Department of Justice. Call or contact Paul today at paul.weidenfeld@www.exclusionscreening.com, or at (800) 294-0952 if you have any questions.

Who Is to Blame for Gaps in OIG and State Exclusion Lists? What Is the Impact on Providers?


The failure to report excludable offenses by state Medicaid offices and licensing boards is a longstanding issue for the OIG. Recent OIG audits and reports have confirmed these state failures to report. For example, an OIG study released in August found that over 12% of terminated providers were able to continue participating in other state Medicaid programs because states were not sharing terminated provider information. In addition, two recent Medicaid Fraud Control Unit (MFCU) audits discovered that they routinely failed to timely report conviction information to the OIG and sometimes did not report them at all.[1] Reporting failures lead to gaps in the OIG Exclusion List (LEIE) because the OIG cannot exclude an individual if the OIG is never informed of the state’s conviction, termination, or suspension of providers. Such failures to report are important because the information that would have been reported can lead to exclusion violations, which are listed on the LEIE. But, state compliance failures are not the only cause of gaps in OIG and State exclusion lists – as we discuss, no matter who is at fault, the provider may pay for anyone’s mistake.

The OIG Exclusion List Has Limited Search Capabilities

One important reason providers should not rely on screening only the LEIE is that its search function is extremely narrow.  If an excluded individual uses a different name, such as a middle or maiden name, an LEIE search using the person’s first and last names my not produce any results.[2]  For example, J. A.[3] was excluded from participation on Georgia’s state exclusion list in August 2015. However, a search for “J.A.” on the LEIE currently produces zero results. 

J.A. LEIE_Redacted

Conversely, when we searched J.A. on SAFERTM, our proprietary exclusion database, we not only found a match on the Georgia list (“J.A.”), but we also found a match on the LEIE and SAM databases for “R.J.A.”. Interestingly, “J.A.” has the same middle and last name as “R.J.A.,” they are both Georgia residents, and they were both excluded from participation in April 2015. Like many states, the identifying information on Georgia’s list is sparse. Nevertheless, it is extremely likely that R.J.A. and J.A. are the same person, which a provider would have missed if he only searched the LEIE for J.A.


Reported Cases May Not Be Picked Up by OIG

Florida’s Agency for Health Care Administration publishes monthly press releases which identify persons terminated from participation in Florida Medicaid.  It expressly states that the exclusion information was “reported to the federal government for placement on the federal exclusion list,” and named providers appear on Florida’s Excluded Provider List.  When we conducted a SAFERTM search for G.B., who was listed on the April 2015 memo as “terminated from participation,” the only two “hits” were from Florida’s state exclusion list.  

G.B. SAFER_Redacted

However, an LEIE search for G.B. produced zero results.  

G.B. LEIE_Redacted

One possible explanation for why G.B. fails to show up on the LEIE could be the administrative process of OIG actually reviewing the reason for the termination and then formally excluding G.B. Nevertheless, a provider who only screens the LEIE and employs or is considering employing G.B. would miss this exclusion.  

OIG Just Misses Some Cases

K.B., a Registered Nurse (RN) with multistate licensure privileges, was placed on probation for substance abuse in February 2005. After testing positive for morphine, Iowa revoked her license and several other states revoked her multistate privileges. While the revocations were reported, the licensure revocation only resulted in K.B.’s exclusion from participation by California and the GSA-SAM in 2010. K.B. is not listed on the LEIE. This means that K.B. is unable to participate in any other state Medicaid program because under the ACA 6501, if you are terminated for cause from participation in one state, then you are terminated in all states, and K.B. is barred from contracting with the federal government. However, if a provider only screened the LEIE he would be completely unaware and could potentially face very hefty fines.

What This Means

Clearly some information is getting lost or mixed up in the reporting pipeline between state Medicaid offices, MFCUs, and the OIG, and the lesson for providers is that merely screening the LEIE is not enough. The examples above demonstrate that human error, narrow search functions, and simply missed information all play a role in the gaps that exist between publication on state exclusion lists and the LEIE.

State Medicaid offices are responsible for compiling and reporting information about excluded providers. However, as demonstrated by the “J.A.” case, the probable human error of transposing names combined with the LEIE’s limited search capabilities could result in a provider employing an excluded person, even though he was properly screened against the LEIE. To avoid this, providers should screen against the LEIE, the GSA-SAM, and all available state lists monthly. Practices should also ensure they use wide search parameters (alternate spellings, full names, maiden names, etc.) when conducting searches or they should select a vendor, like Exclusion Screening, LLC, with a system designed to anticipate these issues.

Notwithstanding name discrepancies, some information just does not make it to the LEIE. As the “G.B.” example reveals, a practice may face considerable monetary fines because it failed to screen the Florida exclusion list and relied solely on the LEIE for exclusion information, and the OIG failed to add G.B.’s name to the LEIE. Similarly, a provider who considered employing “K.B.” would be totally unaware that she was excluded from participation unless the provider screened the GSA-SAM and/or the California exclusion list. Remember that ACA section 6501 states that when an individual or contractor is excluded in one state, he or she is excluded in all states. When a provider misses such state exclusion information, he or she could be liable for CMPs of $10,000 for each claim provided directly or indirectly by the excluded individual, an assessment of up to three times the total amount paid by the government, and potential false claims liability.  Relying on the LEIE’s exclusion information without checking all other available state exclusion lists is a substantial monetary risk for a practice to take. If screening and verifying 40 state and federal exclusion lists each month is overly burdensome for your practice, contact Exclusion Screening, LLC today for a free assessment: 1 (800) 294-0952.

[1] MFCUs are supposed to send a referral letter to the OIG within 30 days of sentencing for the purpose of alerting the OIG about providers excluded from state programs, but the OIG found that in some cases this exclusion information was not referred to the OIG for over 100 days.

[2] We have even found that hyphenated names frustrate LEIE searches even where the actual names are used!

[3] Full names have been redacted for privacy.

Anonymous Compliance Hotline Reports – Friend or Foe?


In the compliance world, anonymous tip lines are touted as a simple and effective method to ensure that providers receive pertinent information about wrongdoing within their offices.  Compliance professionals, however, have divided opinions about the trustworthiness of anonymous compliance hotline reports. An argument in favor of an anonymous reporting option is that it provides an avenue for employees who fear retaliation. A criticism is that anonymous reports may be inaccurate or frivolous. Recent reports shed light on this interesting issue.

The Compliance Report Numbers

According to a 2014 Helpline Calls and Incident Reports survey conducted by the Society of Compliance and Ethics, 39% of compliance professionals reported that anonymous reports were substantiated at the same rate as named reports. Nine percent of respondents found that anonymous reports were substantiated more often than named reports. However, another 35% reported that they were substantiated less often than named reports. The 2015 Hotline Benchmark Report by NAVEX Global adds some clarity to these somewhat contradictory results. According to its data, anonymous reports were substantiated 36% of the time, or 9% less than reports from named individuals. The NAVEX report notes that the gap in substantiation between anonymous and named reports has actually remained at 9% during the last four years. It further goes on to suggest that the gap may be due to an investigator’s inability to follow-up anonymous reports.


An anonymous reporting option is a valuable tool available through ComplianceHotline and will enhance a provider’s compliance program. These reports may be substantiated at a slightly lower rate than named reports. Still, this is not necessarily due to nonsensical reports. Furthermore, capturing issues through both named and anonymous reports ensures that a provider is aware of all issues and may help to keep lawsuits at bay. Call Exclusion Screening, LLC today to enhance your compliance program with our ComplianceHotline solution at 1(800) 294-0952.


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

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