Targeting Failure to Repay As a False Claim

Hand holding pile of cash.

Contractors and providers may face false claims damages when they fail to return overpayments even though no fraud is involved. A recent civil settlement demonstrates that the government is targeting failure to repay, and it can be as costly as fraudulent billing.

Fair Warning Given

A medical practice paid nearly $450,000 to resolve an investigation, 250% more than the contested amount of $175,000. No false billing occurred. In fact, the Department of Justice conceded “credit balances often occur in a medical practice, for example, when two insurers share responsibility for a payment and one pays too much.” The government considered returning an overpayment to be a typical problem that should be resolved during account reconciliation.

The government left no doubt about its ulterior motive in settling the matter.  The acting U.S. Attorney wanted to “send a message that we will aggressively pursue those who seek to unjustly profit” from government programs. Similarly, one investigator predicted the settlement will serve as “a deterrent for others who consider similar practices.”

The Change

The strategy of targeting failure to repay builds on a change to the False Claims Act in 2009. Under the amendment, knowing failure to repay an obligation to the government within 60 days is the same as a false claim. The potential penalty is treble damages. Also, a qui tam relator can file suit in order to recover both part of the settlement and attorney’s fees. That happened to the medical practice in the settlement.

Of course, damages are not due immediately when an overpayment is received. A “knowing” failure requires identifying the overpayment, or failing to exercise reasonable diligence to identify the overpayment. A final rule allows a reasonable amount of time to identify an overpayment. The rule also establishes a six year look back period to find overpayments.

The takeaway: contractors and providers must identify overpayments and return them within 60 days.





The SEC Announces Another Seven-Figure Whistleblower Award

The Securities and Exchange Commission (SEC) last week announced a payout of more than $1 million to a whistleblower who provided information that resulted in a successful SEC enforcement action against a “registered entity” (e.g., a broker-dealer) that “impacted retail customers.” The SEC announced the award, while keeping the details of the enforcement action, the whistleblower, and the total penalty under wraps, in a redaction-filled Order Determining Whistleblower Award Claim.

Since the inception of its whistleblower program in 2011, the SEC has awarded more than $162 million to nearly 50 individuals. The SEC’s largest award to date was over $30 million in September 2014, and the average payout has been more than $3 million. According to the SEC, whistleblower tips have led to successful enforcements actions resulting in over $1 billion in monetary sanctions.

The SEC’s whistleblower program was created by the Dodd-Frank Act in 2011 to encourage those with information about securities law violations to report to the SEC. The Act established the SEC’s Office of the Whistleblower and put in place processes for fielding and investigating tips. If a whistleblower provides “high-quality original information” that leads to an enforcement action where monetary sanctions exceed $1 million, the SEC will issue a bounty equal to 10 to 30 percent of the sanctions. The program has proven highly successful at encouraging those with potentially helpful information to go to the SEC: In fiscal year 2016 alone, the Office of the Whistleblower received 4,218 tips, approximately 12 per day.

SEC ALJ Decision Shows Agency’s “Home Field Advantage” Has Its Limits

In a dense, nearly 60-page decision issued on September 27, 2017, SEC Administrative Law Judge Carol Foelak rejected all claims asserted by the SEC Enforcement Division (the “Division”) in In the Matter of Lynn Tilton, et al. The case involved a series of distressed debt funds that issued notes to institutional investors, using investor proceeds to acquire commercial debt. The Division generally charged that the funds’ manager, Lynn Tilton, and the advisory firms she controlled deceived investors by over-valuing troubled loans held by the funds and collecting excessive fees as a result. The Division also charged that Tilton and her firms falsely told investors that the funds’ periodic financial statements complied with generally accepted accounting principles (“GAAP”) when, in fact, they did not follow GAAP rules governing the fair valuation of assets. Having conducted a lengthy evidentiary hearing late last year, Judge Foelak found for Tilton and her entities on all of the Division’s claims. While the facts of the case are unique and complicated, there are several points worth highlighting.

Most significant, of course, is the total defense victory. While commentators often lament that the Division has a “home field advantage” in its in-house administrative proceedings, the outcome in Tilton suggests that that advantage may be overstated. In the course of a 14-day hearing, the Division put on nine witnesses, including three highly-credentialed experts. The evidence apparently demonstrated that Tilton made arrangements with portfolio companies to reduce their interest obligations to allow them to remain afloat; that she did not reduce the valuation of such loans as a result; that this practice had a favorable impact on her fees; and that information on the actual interest payments being made by portfolio companies, while discernible from the funds’ financial statements, was not easy to find. It is not hard to imagine a judge with a “home field” bias siding with the Division in such a case, especially given the fiduciary duties owed by investment advisers to their clients.

Judge Foelak, however, dismissed all of the Division’s charges, including charges that require no proof of fraudulent intent. In so doing, she carefully parsed the disclosures in complex fund documents, took into account the sophistication of the funds’ investors, and applied a healthy dose of common sense about the expectations of investors who put their money into such vehicles. While SEC administrative proceedings certainly pose challenges for defense counsel, Tilton is a reminder that those challenges are not insurmountable.

The opinion also offers some interesting procedural takeaways. First, Judge Foelak rejected Tilton’s argument that the Division violated its “Brady” obligations by failing to disclose that it had retained its experts before bringing the case, enlisting their help in reviewing evidence and shaping the Division’s theories (which Tilton contended was evidence of witness “bias”). Distinguishing this case from one in which a purportedly neutral trial witness had been extensively involved in an underlying criminal investigation, Judge Foelak ruled that such post-investigation/pre-filing expert consultation was insufficient to impose any affirmative disclosure obligation on the Division.

Judge Foelak also rejected Tilton’s arguments that the Division violated its “Jencks” obligation to produce witness statements by withholding notes of witness interviews, observing that there was no evidence to suggest that any witness had actually “adopted or approved” such notes as reflecting their own statements. Finally, while finding that Tilton had failed to prove an affirmative defense of “reliance on accountants,” Judge Foelak noted that such reliance was nonetheless relevant to the “degree of culpability for any violations” – i.e., whether the Division had carried its own burden of proving fraudulent intent, recklessness, or negligence.

Under SEC Rules of Practice, the Division may appeal Judge Foelak’s decision to the Commission itself within 21 days. If it does so, and the Commission grants review, then it may make any findings of fact and conclusions of law that it deems to be supported by the record. One might reasonably wonder why the Division can appeal an adverse ALJ decision to the very body that authorized its enforcement action in the first place. That, however, is a much larger topic for another day.

Choice of Counsel Upheld in New Zealand – This Time

Counsel of choice is important

Client consults with attorney on courthouse steps.

When the New Zealand Serious Fraud Office (SFO) summons you to attend an interview regarding an investigation of corporate misconduct, you may be surprised to learn SFO has the power to prevent your preferred counsel from accompanying you. In fact, many international regulatory bodies can exclude an attorney from the client’s compulsory interview. If a client is caught unaware, this power can be devastating to successful resolution of the proceeding.

SFO Prevents Choice of Counsel

On October 25, 2016, John James Loughlin was summoned to appear for an interview by SFO. The interview was “compulsory” and one “where the interviewee cannot refuse to answer a question on the grounds of self-incrimination.” While he was entitled to counsel, SFO informed Mr. Loughlin his current attorney was excluded. Mr. Loughlin was a director and chairman of the Board of a giant retail company. His attorney, Mr. Corlett, also represented several other members of the Board. SFO, drawing on its implied statutory power, denied Mr. Corlett admission to the interview on the grounds that Mr. Corlett attended interviews of his other clients who were also witnesses. Therefore, he was privy to information he could inadvertently disclose to Mr. Loughlin. SFO feared this disclosure could color Mr. Loughlin’s testimony at the interview.

Choice of Counsel Allowed – This Time

In an August 2017 decision, Loughlin v. The Director of the Serious Fraud Office, the High Court of New Zealand (a court of general jurisdiction but not New Zealand’s highest court) overruled SFO’s prohibition. Mr. Corlett was permitted to attend the interview because the judge found no particular facts suggesting the attorney’s presence would prejudice the investigation.

The takeaway, however, is that SFO may compel a witness to answer questions without the advice of a trusted representative. Precedent discussed in Loughlin upheld the exclusion of the attorney. SFO’s decision to exclude an attorney is limited only by a reasonability standard. In certain circumstances, its inherent authority to challenge counsel is seemingly unquestioned. Moreover, one of the reasons SFO might seek to exclude counsel is to prevent the coordination of defenses among witnesses—even though that is precisely the reason witnesses might want to use the same counsel. Thus, SFO’s power to limit coordination is as daunting as its ability to exclude chosen counsel from a potentially case-altering, and life-altering, event.

Global Perspective Needed

In the United States, constitutional, statutory, and ethical protections benefit the client rather than the tribunal. The Sixth Amendment and US Supreme Court jurisprudence protect choice of legal representation—barring a non-waivable conflict of interest in multiple-representation criminal cases as in Wheat v. US.

It is hazardous to assume similar protections will exist in international jurisdictions. New Zealand, Ireland, and Australia, for example, all follow a similar test: strongly presuming freedom of choice of legal representation, but limited by the needs of the tribunal. Knowledgeable counsel, with global connections, can prevent the predicament of standing before government investigators without one’s counsel of choice.

Kickback Training – What It Doesn’t Cover

Refusing kickback

One individual puts up hand to stop money being handed by another person.

Effective training prepares contractors and providers to recognize more than kickbacks. The example below reveals that not all kickback violations are intuitively obvious. What seems a clear violation to those familiar with anti-kickback and false claims statutes, may seem just a straightforward business arrangement to someone unfamiliar with them. After all, what is wrong when providers perform the activities for which they are reimbursed, no one lies, and no false documents are created? Read More Continue Reading

Criminal Finances Act 2017 – New Corporate Offences of Failing to Prevent Facilitation of Tax Evasion

The United Kingdom’s National Risk Assessment of money laundering and terrorist financing in October 2015 identified three priority risks faced by the UK and concluded that a more robust enforcement response is required. These changes were to be underpinned by a partnership between the government and the private sector to effect a significant change in the law.

In April 2016, the UK government published its action plan on anti-money laundering and counter-terrorist finance, setting out the steps to address such risks and resulting in the commissioning of the Criminal Finances Act 2017 (the “Act”), which received royal assent on 27 April 2017. The Act will come into force on 30 September 2017.

The Act is intended to strengthen the UK government’s ability to confiscate the proceeds of crime; to improve the international reach of enforcement; and to extend the applicability of enforcement to also cover investigations under the Terrorism Act 2000. The Act will bring about the most significant changes to the anti-money laundering and terrorist finance regime in the UK since enactment of the Proceeds of Crime Act 2012.

We previously published an article on a widely anticipated new offence of corporate failure to prevent economic crime (which offence would have incorporated the failure to prevent fraud, money laundering and false accounting), but the Act has not included this offence.   However, the Act does include two new corporate criminal offences for the failure to prevent the facilitation of tax evasion, whether in the UK (Section 45) or abroad (Section 46).   The Act also includes provisions relating to:

  1. The seizure and forfeiture of the proceeds of crime stored in UK assets, extending the current law to include value stored in bank accounts and high-value property.
  2. “Unexplained Wealth Orders”—increased powers to require those suspected of corruption to explain the source of their funding. In order to obtain an unexplained wealth order, the value of the unexplained funds must exceed £100,000 in value and the court must be satisfied that there are reasonable grounds for suspecting that funds have been unlawfully obtained.
  3. The sharing of information between regulated companies when requested from each other or when the National Crime Agency requests that information be shared.
  4. An extension of the current moratorium period in which Suspicious Activity Reports can be investigated.
  5. Two new corporate offences of the failure to prevent facilitation of tax evasion.
  6. Disclosure Orders for money laundering investigations, extending the powers already in existence for corruption and fraud investigations.
  7. Combating the financing of terrorism so that the existing legal regime for investigations into criminal finance can also apply to investigations relating to offences under the Terrorism Act 2000.

The UK government has issued draft guidance on the new corporate offences for the failure to prevent tax evasion, and the guidance confirms the government’s belief that a “relevant body” should be criminally liable when it fails to prevent those who act for it, or on its behalf, from criminally facilitating tax evasion. The guidance defines a ”relevant body” as an incorporated body (typically a company) or partnership; ”relevant body” does not include natural persons, i.e., individuals (as opposed to legal persons, which include entities).

The new offences will be committed when a relevant organisation fails to prevent an associated person from criminally facilitating the evasion of a tax, whether the tax evaded is owed in the UK or in a foreign country. The guidance is similar to the guidance to the UK Bribery Act 2010 (“Bribery Act”), which sets out six key principles that organisations should adopt, including the following:

  1. Risk assessment;
  2. Proportionality of risk-based prevention procedures;
  3. Top level commitment: Tone from the top;
  4. Due diligence;
  5. Communication (including training); and
  6. Monitoring and review.

Organisations should start to consider now whether they have reasonable procedures in place to prevent someone acting for them (or on their behalf) from facilitating tax evasion in the UK or in a foreign country.

A “prevention procedures” defence is available to corporate bodies, similar to the “adequate procedures” defence that is available under the Bribery Act. For a corporate body to avail itself of the “prevention procedures” defence under the Act, it must prove that it had “such prevention procedures as it was reasonable in all the circumstances to expect… or [that] it was not reasonable in all the circumstances to expect [the company] to have any.”

Some businesses will not be required to put in place prevention procedures where it is considered unreasonable to do so. For smaller businesses and certain low risk industries, the guidance sets out minimal steps that should be taken nevertheless, including the release of a statement from the board proscribing the illegal activities, training of staff, and implementation of clear reporting and whistleblowing procedures.

If you are unclear on the steps that your business should take, or if you would like us to help you review or design prevention procedures, please contact a member of our team.

Changes to Whistleblowing Regulation under French Data Protection Law

In June 2017 the French data protection authority, the CNIL, published a revised norm for reporting systems ( “AU-004”) that will permit the implementation of the changes recently  introduced by the new French Anti-corruption Law “Sapin II” (as set out in our previous article “New French Anti-corruption Law Sapin II”).

To read more about the change to the French data protection regulation.

Cell Phone Warrant – Issues in Split Decision

Agents Executing CellPhone Warrant

Riley v. California sparks disagreement about a cellphone warrant in United States v. Griffith, No. 13-3061, 2017 U.S. App. LEXIS 15636 (D.C. Cir., Aug. 18, 2017). In Riley, the Supreme Court requires a warrant to search a cellphone found incident to arrest. Issues in Griffith include requirements for a cellphone warrant in a suspect’s home, whether a phone can be searched after execution of a cellphone warrant, the good faith exception to the exclusionary rule, and personal liability for police.

These issues summarized below are discussed in more detail in our article in Law360 (available by subscription here). We predict more litigation about this warrant because the dissent explicitly hopes the Circuit en banc or the Supreme Court will intervene “to cure today’s grievous error.” Read more. Continue Reading

Summary of U.S. Department of Justice’s Guidance, “Evaluation of Corporate Compliance Programs”

Summary of Compliance Guideline

The Criminal Division’s Fraud Section of the U.S. Department of Justice (the “DOJ”) has released guidance on how the DOJ will determine the effectiveness of a company’s corporate compliance program.  The guidance, entitled Evaluation of Corporate Compliance Programs[1] (the “Compliance Guideline”), provides examples of topics and sample questions that are frequently used by the DOJ in the evaluation of a corporate compliance program.

While the topics and questions are not new, the Compliance Guideline does reinforce the message that the DOJ’s focus is on the concrete steps a company’s leadership takes to foster a corporate culture of compliance.  The Justice Department’s Compliance Counsel, Hui Chen, emphasized the difference between a “paper program” and a “real program.”  “The answers are not in the glossy diagrams of a company’s ‘core values’ or their training slides; rather, they are in what happens in real life, in the smallest details that manifest themselves in the company’s daily operations.”[2]

The Compliance Guidelines provide useful insights for compliance professionals on what to expect in the event of a DOJ investigation and furthermore provide a framework to assess a company’s compliance program, strengthen existing polices, and identify areas that need improvement.  While the DOJ does not use an established formula in assessing the effectiveness of corporate compliance programs, the Compliance Guideline does provide transparency into factors the DOJ will take into consideration when evaluating the adequacy of a company’s compliance program.  The DOJ is careful to note that the Compliance Guideline is not a checklist or a formula and that many of the topics are found in the United States Attorney’s Manual, the United States Sentencing Guidelines, the Fraud Section corporate resolution agreements, the DOJ and Security and Exchange Commission’s A Resource Guide to the U.S. Foreign Corrupt Practices Act, the Organization for Economic Co-operation and Development Council’s Good Practice Guidance on Internal Controls, Ethics, and Compliance, the United Nations Office on Drugs and Crime, and the World Bank.

Topics and Questions – What the DOJ Will Look to When Evaluating a Compliance Program

The Compliance Guideline sets forth eleven topics and questions investigators may ask when evaluating the adequacy of a compliance program.  These are factors prosecutors will take into consideration when conducting an investigation of a corporate entity, determining whether to bring charges, and negotiating plea or other agreements.  Companies should use these topics and questions to serve as best practices to measure corporate compliance programs and further refine existing programs

  1. Analysis and Remediation of Underlying Misconduct

During the course of an investigation, the DOJ will look through audit reports, complaints, and prior investigations of similar misconduct for any missed prior opportunities to detect the misconduct.  Companies must ensure there are no system vulnerabilities or accountability lapses in detecting issues.  Similarly, companies should have a system in place to expose vulnerabilities and implement corrective measures to reduce the risk of repeat misconduct.

  1. Senior and Middle Management

The Compliance Guideline reiterates that compliance starts at the top and the DOJ will look to whether management properly sets the tone for the company.  The onus will be on senior management, through words or actions, to foster and encourage an ethical culture.  Not only should leadership take concrete actions in the company’s compliance and remediation efforts, management at all levels must model appropriate behavior to employees.  Further, management has a responsibility to ensure appropriate information is shared among different components of the company – including the board of directors.  The board and senior management will need to examine pertinent information in their exercise of oversight, have access to compliance expertise, and the board and external auditors should be holding regular sessions with compliance and control functions.

  1. Autonomy and Resources

Whether a company’s compliance department is internal or functions are outsourced to an external firm, investigators will be inspecting to determine whether the compliance department is autonomous and can remain objective from the rest of the company.  A company will want to make sure compliance personnel are independent, have the appropriate experience and qualifications for their role and responsibilities, maintain a level of stature that is comparable to other departments within the company, have access to key decision-makers such as the board of directors, are evaluated by appropriate senior management, have a low turnover rate, and play a role in the company’s strategic and operational decisions.  Compliance and control personnel must be empowered to identify, escalate, and address problems.

  1. Policies and Procedures

It’s not enough to merely have compliance policies and procedures in place, the DOJ will be looking at a company’s process for designing and implementing the policies and procedures, the company’s ability to evaluate the usefulness of policies and procedures, and whether the departments or functions have ownership of and are held accountable for their oversight.  In examining the compliance policies and procedures, the DOJ will examine whether there has been clear guidance and training for the key gatekeepers (e.g., the persons who issue payments or review approvals) in the control processes.  The gatekeepers must be aware of the process in order to properly raise concerns.  Further, the policies and procedures must be adequately disseminated and accessible to all employees.

Compliance personnel will need to be responsible for operational integration of the policies and procedures, consult with the appropriate officers or business segments, and roll out the policies and procedures while making sure employees fully understand them.  So as to avoid future misconduct, the company must have controls in place to detect and prevent the misconduct, restrict or rigidly control access to funding to prevent abuse, and have a process in place to manage outside vendors.  Employees in each department with approval authority or certification responsibilities will need to know what to look for, and when and how to escalate concerns.

  1. Risk Assessment

There needs to be a methodology to identify, analyze and address risks for misconduct within the company.  The DOJ will examine the type of information or metrics a company has collected to detect misconduct and how that information or metric is being used to inform the company’s compliance program of possible as well as manifested risks.

  1. Training and Communications

The DOJ will focus on the type of training provided to employees who work in high-risk and control positions.  Corporations must ensure: (1) employees in relevant control functions are receiving adequate and effective training; (2) high-risk and control employees are receiving tailored training that addresses the risks in the area where a misconduct may occur; and (3) appropriate analysis is undertaken of which employees should be trained and on what subjects.

In addition to identifying the employees that must receive appropriate training, companies will want to ensure the training is effectively communicated.  The DOJ will look to whether the format of the training (i.e. web-based, in-person seminar, interactive, etc.) and the language that training was conducted in is appropriate for the intended audience.  Further, the DOJ will examine whether the company has measured the effectiveness of training that is given.

Leadership will need to communicate to employees the company’s position on any misconduct that has occurred, including when an employee is terminated for failure to comply with a company’s policies and procedures.  Further, companies must ensure employees have adequate access to resources that provide guidance on compliance policies and procedures.

  1. Confidential Reporting and Investigation

The DOJ will look to whether the company has implemented an effective and confidential reporting mechanism, including the ability to evaluate the risk level or seriousness of reports.  Once a report comes in, the company must timely respond to the complaint, adequately analyze and identify the misconduct, and determine the persons involved.  If an investigation is warranted, it must be remain independent, properly scoped and documented, and if appropriate, involve all levels of senior leadership up to the board of directors.  In response to the investigation, remediation must be appropriate in light of the investigation findings.

  1. Incentives and Disciplinary Measures

It is imperative for a company to implement appropriate disciplinary measures upon identifying misconduct.  All individuals involved in the misconduct must take accountability for their role, particularly employees that have a management role in the company.  Disciplinary actions must be fair and consistent for all employment levels.

In addition to disciplining misconduct, a company should have a process in place to incentivize good behavior.  The DOJ will look for concrete examples of incentives for compliance and ethical behavior such as promotions and rewards.

  1. Continuous Improvement, Periodic Testing and Review

A well-rounded compliance program will need to undergo periodic review and auditing to test controls and identify system vulnerabilities.  Investigators will examine the types of audits or control testing a company conducts on their compliance programs, audit findings, whether remediation progress is reported to management and the board on a regular basis, how management and the board follow-up on those reports, and how often internal audits are conducted in high-risk areas.  Additionally, compliance policies, procedures, and practices will need to be periodically reviewed and risk assessments will need to be continuously updated.

  1. Third-Party Management

When relying on third parties outside of a company’s control, the company will want to implement a risk-based process to manage those third parties.  The business rationale for using a third party will need to be appropriately documented, including payment terms and the work to be performed.   Due diligence on third parties must be conducted to identify red flags and the company will need a process to identify and monitor compliance issues, including methods of remediation such as suspension or termination of the third party relationship.

  1. Mergers and Acquisitions

Mergers and acquisitions must undergo a due diligence process to identify misconduct or the risk of misconduct.  The company will need a process for tracking and remediating misconduct or misconduct risks identified during the due diligence process.  Further, the company will need a process for implementing their compliance policies and procedures at the new entity.

[1] The U.S. Department of Justice Criminal Division’s Fraud Section publication of the Evaluation of Corporate Compliance Programs may be found here.

[2] Hui Chen, DOJ Compliance Expert, Interview on Corporate Compliance with Andrew Weissmann and Hui Chen (Feb. 2, 2016).

Exclusion from Healthcare Programs for a Misdemeanor?

Even a misdemeanor guilty plea can have far reaching ramifications in the healthcare industry. The Sixth Circuit recently upheld a decision of the Department of Health and Human Services (HHS) that a healthcare provider was subject to mandatory exclusion following a guilty plea to misdemeanor misbranding. As the court recognized, trial counsel had anticipated this possibility and warned the provider about potential exclusion.

Pharmacist Parrino consistently filled prescriptions for Pulmicort with a less potent amount of budesonide. He resolved the investigation by pleading guilty to introducing misbranded drugs into interstate commerce in violation of 21 U.S.C. §§ 331(a) and 352(a). Because misdemeanor misbranding is a strict liability crime, Parrino did not need to admit that he intended to prepare the medications incorrectly as part of the plea. HHS nevertheless decided its mandatory exclusion authority applied, excluded Parrino from federal healthcare programs for five years, and effectively ruined Parrino’s livelihood as a pharmacist during that time. Parrino appealed the decision by claiming that permissive (rather than mandatory) exclusion authority applied to misbranding. He also argued that HHS violated his fundamental right to property by acting arbitrarily when it excluded him for a strict liability offense that lacked intentional misconduct.

Disagreeing with a decision from the Fourth Circuit, the Sixth Circuit agreed with the Ninth, Tenth, and First Circuits that a healthcare provider has no “fundamental right to participate in federal health care programs.” The court reasoned that no property right is created when someone is allowed to become a provider to federal healthcare programs because the government makes “no clear promises” of entitlement to the provider and federal health care programs are not intended to benefit providers. Deciding that the type of exclusion was not crucial, the court held that HHS needed only a rational basis to justify excluding the pharmacist. Under this standard of review, the court readily upheld the rationality of excluding a pharmacist who filled sub-potent medications and wasted government funds.

In an instructive footnote, the court referred to Parrino’s attempt to withdraw his guilty plea based a claim of ineffective assistance of counsel when he learned that HHS planned to exclude him. On that issue, the court held that counsel was effective by providing sufficient notice of the possibility of exclusion, even though counsel predicted exclusion would considered under the permissive standard rather than the mandatory standard.