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OmniCare’s Hundred Million Dollar False Claims Act Settlement

OmniCare’s One Hundred Million Dollar False Claims Act Settlement

The Department of Justice recently announced Omnicare’s One Hundred Million Dollar False Claims Act settlement ($124 million, to be precise).

Omnicare Inc., the nation’s largest provider of pharmaceuticals and pharmacy services to nursing homes, has agreed to pay $124.24 million for allegedly offering improper financial incentives to skilled nursing facilities in return for their continued selection of Omnicare to supply drugs to elderly Medicare and Medicaid beneficiaries, the Justice Department announced today .   Omnicare is headquartered in Cincinnati, Ohio. “Health care providers who seek to profit from providing illegal financial benefits will be held accountable,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery.  “Schemes such as this one undermine the health care system and take advantage of elderly nursing home residents.”

“Omnicare provided improper discounts in return for the opportunity to provide medication to Medicare and Medicaid beneficiaries,” said Steven M. Dettelbach, United States Attorney for the Northern District of Ohio. “Nursing homes should select their pharmacy provider based on the best quality, service and cost to the residents, not based on improper discounts to the nursing facility.”

The settlement resolves allegations that Omnicare submitted false claims by entering into below-cost contracts to supply prescription medication and other pharmaceutical drugs to skilled nursing facilities and their resident patients to induce the facilities to select Omnicare as their pharmacy provider.  The facilities were participating providers under agreements with Medicare and Medicaid.   In addition to the facilities’ own claims for reimbursement from Medicare for short-term rehabilitation treatment rendered to patients, Omnicare submitted additional claims for reimbursement to Medicare and Medicaid for drugs Omnicare supplied.

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Medicine-3

Another False Claims Act Complaint Against Hospitalists

Another False Claims Act Complaint Against Hospitalists  

Recently, the government filed another False Claims Act complaint against hospitalists in United States ex rel Bijan Oughatiyan v. IPC Hospitalist Co., 1:09-CV-05418 (N.D. Ill. June 16, 2014) (DE-48).  IPC Hospitalist Company, through IPC Hospitalist Management Company and its subsidiaries, employs more than 2500 hospitalists across the U.S. across 28 states.

The complaint alleges that IPC Hospitalist Company, IPC Hospitalist Management Co., and their affiliates and subsidiaries, engaged in a systemic pattern of submitting records to IPC’s billing department for the most expensive services claiming higher and more expensive levels of medical services than were actually performed, i.e. “upcoding,” for hospitalist services. According to the complaint, IPC uses an online portal and virtual system to continuously monitor its financial and clinical performance. In addition, IPC audits the billing information entered by hospitalists for completeness and accuracy.

Of import, the complaint also analyzes IPC’s compensation structure which includes a “physician incentive plan.” In addition to receiving a base salary and benefits, IPC hospitalists receive bonuses pursuant to IPC’s physician incentive plan that are based upon the amount billed by the hospitalist. In fact, IPC calculates the total amount billed by each hospitalist on a monthly basis, and subtracts from that amount the cost of the hospitalist’s salary and benefits. Of the remainder, IPC keeps 30 percent and pays the hospitalist 70 percent. Thus, according to the complaint, the more IPC hospitalists bill, the more IPC takes home and the easier it is for IPC to meet their investors’ earnings and revenue expectations.

Further, IPC ranks hospitalists against one another based on their individual billing patters, IPC routinely discussed and compared hospitalist billing patterns at pod meetings, and IPC hospitalists who consistently use lower or moderate billing codes are pressured by IPC trainers to change that practice.

For these reasons, the government alleges that corporate management knowingly pressured hospitalist employees to engage in the pattern of upcoding and to maximize their billings through the physician incentive plan and that was part of a systemic scheme to maximize billings and submit upcoded claims for payments to the U.S.

In light of the recent noteworthy multi-million dollar settlements with Halifax and Tuomey involving physician incentive compensation arrangements between hospitals and physicians, the complaint against IPC Hospitalist is yet another reminder that the government will closely scrutinize these relationships and compensation arrangements although the government’s theory of False Claims Act liability in the IPC Hospitalist complaint is more straightforward than the theories of liability employed in Halifax or Tuomey because it highlights a corporate culture that essentially aided and abetted upcoding.

Nonetheless,the emphasis in IPC on the “physician incentive plan” demonstrates that arrangements between physicians, physician-management companies, and hospitals should be properly evaluated to ensure that any bonuses are based on quality or performance metrics and are not entirely based on the potential to influence or induce referrals to the hospital. Indeed, even if a physician is an employee, the protections provided to physician-employees are not absolute and must comply with applicable self-referral and anti-kickback laws.

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Andrew S Feldman Speaks at Trinity College Reunion Weekend

Andrew S. Feldman Speaks at Trinity College Reunion Weekend

Mr. Feldman attended his ten year reunion at Trinity College reunion weekend in Hartford, Connecticut over this past weekend. During the reunion, Mr. Feldman enjoyed the unique opportunity to discuss trends in white collar crime and the enforcement priorities of the Department of Justice and the Securities and Exchange Commission.

 

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Medicine-2

New Challenges for Compounding Pharmacies

 New Challenges for Pharmacy Compounding in Florida

Historically, compounding has occupied a significant role in U.S pharmacy practice. In fact, by 1938, the United States Pharmacopeia had been providing compounding instructions for more than 100 years. State pharmacy practice acts also regulated and included the term compounding. Far from restricting compounding, the states specified that state-registered or licensed health care professionals were permitted to engage in the practice of compounding.

One issue that remains important is whether or not the FDA has authority to regulate compounding – a question which depends on whether compounding qualifies as manufacturing new drugs since FDA has the authority to approve newly manufactured drugs and devices.  The Fifth Circuit, for example, held that the definition of a new drug was never intended to apply to compounded medications.

Since 2005, however, a series of tragic incidents have occurred resulting from unsafe or unsterile compounding practices. Most significantly, the meningitis outbreak in Massachusetts caused by injectable drugs compounded at New England Compounding Center (NECC) resulting in a $100 million settlement, caught the attention of public and legislators. Similarly, the deaths of 21 polo horses resulting from unsterile compounding practices in Florida prompted strong reactions and rhetoric from federal regulators and state boards of pharmacy.

Most recently, compounding pharmacies in Texas and other states, sometimes through physician spokespeople or sales representatives, have also offered physicians lucrative investment opportunities in compounding pharmacies which has caught the attention of the national news media,

Lastly, the FDA has executed numerous onsite inspections (reactive and proactive) at compounding pharmacies since October of 2012, and in many cases, has issued a Form 483 which signals quality problems, including contaminated products and sterile practices that create risks of contamination. In addition, in its recent non-binding recommendations regarding compounding pharmacy the FDA reiterated that if compounding pharmacies do not meet very specific criteria to compound drugs, then they will be subject to good manufacturing practices (GMP), newly approved drug application requirements, and the labeling of drugs for adequate use requirements. More importantly:

“If FDA determines that an individual or firm compounds a drug product that does not meet the conditions of section 503A, then ….the individual or firm that compounds the drug product may also be subject to a warning letter, seizure of product, injunction, and/or criminal prosecution..”

Florida Special Permit Rule and Proposed Rule for 2015

At the end of 2013, based on the influx of compounding pharmacies in Florida, Florida reevaluated some of these important issues and passed Florida Statute Section 465.0196.

Among other things, the new law requires all pharmacies engaging in sterile pharmacy compounding and any new establishments seeking to engage in sterile pharmacy compounding, with the exception of Special Parenteral/Enteral (Stand Alone) and Special Parenteral/Enteral (Extended Scope) pharmacies, are required to obtain special permits. The deadline for obtaining permits was March 21, 2014.

Prior to obtaining a special compounding permit, a new establishment must also:

  • Submit copies of fingerprints electronically to a Live Scan vendor and
  • Must undergo an inspection.

Requirements for all (existing and new) special permit holders also include:

  • Completing a 35 question application focusing, primarily, on quality assurance and quality control procedures and the extent to which certain special equipment and special techniques will be used.
  • Development of a policies and procedures that will be maintained for the compounding, delivery, and dispensing of sterile preparation prescriptions;
  • Documented ongoing quality assurance program that monitors personnel performance, equipment, and preparations; and
  • Quality assurance audits at regular planned intervals, including infection control and sterile technique audits.

Compounding Quality Act (CQA) and Compounding Clarity Act (CCA)

In response to the recent tragic events resulting from unsafe compounding practices, Congress proposed the Compounding Clarity Act (CCA), and the Compounding Quality Act (CQA).

The CAA seeks to amend Section 503A of the FDCA, although, thus far, the only change to 503A is that compounders may now advertise their compounding services without running afoul of the misbranding provisions as long as the advertising is “not false or misleading.”

Indeed, the following sentence in Section 503A has been deleted entirely:

A drug may be compounded under subsection (a) of this section only if the pharmacy, licensed pharmacist, or licensed physician does not advertise or promote the compounding of any particular drug, class of drug, or type of drug.

The Senate has not yet considered the remaining provisions of the CCA and it may very well die in Committee.

According to the current version of Section 503A, compounders are exempt from the FDCA requirements concerning current good manufacturing practices, the labeling of drugs with adequate directions for use, and the approval of drugs under new and abbreviated drug applications, provided that they meet specific criteria.

The CQA amends Section 503B of the Food Drug and Cosmetics Act (FDCA). According to the CQA, certain compounded medications will not be subject to (1) FDA’s misbranding provision (2) FDA’s new drug application filing requirements or (3) Section 582 of the FDCA, which sets forth rules governing what substances are generally recognized as safe for their intended use provided thatthey meet eleven requirements for registration as an outsourcing facility.

Some bright line rules regarding outsourcing facilities:

  • A facility only compounds “sterile drugs” which are drugs intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under State or federal law.
  • Drugs must be compounded in an outsourcing facility under the direct supervision of a licensed pharmacist.
  • An outsourcing facility, by definition, is not required to be a licensed pharmacy .

Furthermore, outsourcing facilities are subject to:

  • Annual reporting requirements each June.
  • Unannounced inspections based on several predetermined “risk factors.”
  • Adverse event reporting requirements.
  • FDA’s rigorous Good Manufacturing Practices (GMP) standards.

Florida versus FDCA

At a minimum, there are two significant issues with respect to the differences between the current version of 503A of the FDCA and the Florida Administrative Code governing pharmacy compounding.

First, 503A does not specifically exempt office use compounding from certain FDCA requirements related to  misbranding, new drug application filings, or substances generally recognized as safe for their intended use pursuant to Section 582 of the FDCA. By comparison, if a series of requirements are met, Florida specifically permits a pharmacist to dispense a quantity of a compounded drug to a practitioner in a health care facility or treatment setting, including a hospital, ambulatory surgical center, or a pharmacy.

Second, Florida’s definition of compounding is open to broad interpretation and includes “incorporating ingredients to create a finished product for dispensing to a patient for administration by a practitioner or the practitioner’s agent” and “preparing a unique finished product containing any ingredient or device” covered by the definitions of medicinal drugs or an institutional formulary system.  By contrast, 503B of the FDCA states that compounding is “the combining, admixing, mixing, diluting, pooling, or reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug.”

Open Questions

  • To what extent will FDA delegate some of its 503A enforcement decisions to State Boards of Pharmacy?
  • Will the FDA rely on the definition of compounding in 503B for purposes of enforcement?
  • To what extent will compounders seek the protections provided by the outsourcing facility safe-harbor?
  • How aggressively will FDA monitor and enforce outsourcing facility compliance with GMP regulations  given that compounders, traditionally, have not been subject to or familiar with GMP?
  • Based on the new regulations, will relators continue to allege new False Claims Act theories of liability based on FDCA violations? Will such theories gain more traction than before under a worthless services theory?
  • Will compounders now more aggressively market compound medications to physicians and others given the official deletion of the language in Section 503 restricting advertising?
  • Will compounders continue to argue, based on applicable federal case law, that compounding is not manufacturing, and therefore, the FDA has no authority to impose additional requirements or restrictions on the century old practice? In light of the CQA and the current version of 503A of the FDCA, such an argument seems tenuous, at best. Importantly, the CQA makes it clear that the FDA still considers compounded drugs to be new drugs unless the compounding pharmacy satisfies the extensive requirements provided in Section 503A or 503B.
  • What steps will compounding pharmacies currently compounding controlled substances, e.g., pain creams, take to simultaneously comply with DEA registration requirements, Florida special permit requirements, and, where applicable, Section 503A of the FDCA?
  • Will the rigorous special permit application requirements in Florida discourage new entrants in the market?
  • Will the current regulatory environment lead to more misbranding prosecutions, inspections, or Form 483s? Will the regulations make compounding pharmacies more vulnerable to unknowing violations of the misbranding statute, which is a criminal statute?

 

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What is a Foreign Official Under the FCPA?

United States v. Esquenazi: Eleventh Circuit Becomes the First Court of Appeals to Decide What Constitutes an “Instrumentality” of a Foreign Government Under the FCPA

Recently, the Eleventh Circuit became the first Court of Appeals to decide the question of whether an entity constitutes an “instrumentality” of a foreign government for purposes of the FCPA.

I. Facts

Two co-owners of a telecommunications company in Florida, Terra Telecommunications (“Terra”), purchased phone time from foreign vendors and resold minutes to customers in the United States. One of Terra’s main vendors was Telecommunications D’Haiti SAM (“Teleco”). Over time, Terra’s outstanding debt to Teleco increased based on previous agreements between the two companies.  To relieve some of the debts they owed to Teleco, Terra sent monies to officers of Teleco. Later on, the two co-owners of Terra also made payments to a shell company owned by other Teleco officials.

II. FCPA Provisions Addressing “Instrumentality” of a Foreign Government

The anti-bribery provision of the FCPA specifically prohibits a “domestic concern” from:

“Making use of the mails or any means …of interstate commerce corruptly in furtherance of a bribe to “any foreign official,” or to any person, while knowing that all or a portion of such money or thing of value will be offered, given, promised, directly or indirectly to any foreign official…

For purposes of  —-

influencing any act of decision of such foreign official …in order to assist such domestic concern in obtaining or retaining business for or with, or directing business to, any person.”

See 15 U.S.C. Section 78dd-2(a)(1),(3)

A “domestic concern” includes:

  • Any individual who is a citizen, national, or resident of the U.S.; and
  • Various business entities, e.g., partnerships, corporations, organizations, business trusts, so long as the business entity has its principal place of the business in the U.S. or is organized under the laws of the U.S. or a territory, possession, or commonwealth of the U.S., e.g., Puerto Rico.

See 15 U.S.C. Section 78dd-2(h)(1)(A)-(B)

A “foreign official” includes, among other things:

  • Any officer or employee of a foreign government;
  • Any department or agency of a foreign government; and
  • Any instrumentality of a foreign government.

See 15 U.S.C. Section 78dd-2(h)(2)(A)

III. The Esquenazi Decision

A. Two Prong Test for “Instrumentality” in Esquenazi

The court upheld the Teleco owners’ convictions under the FCPA, reasoning that, the district court’s jury instructions with respect to what constituted an “instrumentality” of a foreign government were proper. The jury instructions in dispute were as follows:

To decide whether Teleco is an instrumentality of the government of Haiti, you may consider factors, including:

One, whether it provides services to the citizens and habitants of Haiti

Two, whether its key officers and directors are government officials or are appointed by government officials

Three, the extent of Haiti’s ownership of Teleco, including whether the Haitian government owns a majority of Teleco’s shares or provides financial support such as subsidies, special tax treatment, loans or revenue from government mandated fees.

Four, Teleco’s obligations and privileges under Haitian law, including whether Teleco exercises exclusive or controlling power to administer its designated functions

And, five, whether Teleco is widely perceived and understood to be performing official or governmental functions.

Terra contended that these instructions caused them to convict Terra simply based on the fact that Teleco was a government owned entity providing a service. The Eleventh Circuit disagreed finding that the instructions given to the jury did not mislead the jury or incorrectly state the law. The Court then established a two prong test for deciding whether an entity might constitute an “instrumentality” of a foreign government:

  • First Prong – Whether the foreign government “controls” the entity
    • Foreign government’s formal designation of that entity;
    • Whether the government has a majority interest in the entity;
    • The government’s ability to hire and fire the entity’s principals;
    • The extent to which the entity’s profits, if any, go directly into the government fisc;
    • The extent to which the government funds the entity if it fails to break even; and
    • The length of time that these “indicia” have existed, e.g. the length of the government’s control over the entity.
  • Second Prong – Whether the entity performs a function the controlling government treats as its own.
    • Whether the entity has a monopoly over the function it provides;
    • Whether the government subsidizes the costs associated with the entity providing services;
    • Whether the entity provides services to the public at large in the foreign country; and
    • Whether the public and the government of that foreign country generally view the entity to be performing a government function.

B. Deliberate Ignorance Instruction

At trial, the court instructed the jury that they may find that the co-owner knew that the payments to foreign officials that he was authorizing were illegal if they found that he deliberately avoided knowledge of the fact that payments to those foreign officials were unlawful. The government argued that such an instruction was proper since, as a financial executive, he was in a position to know the illegality of the payments he was making.

The Eleventh Circuit disagreed finding that there was no evidence showing that the co-owner deliberately avoided learning whether the payments were illegal. However, the court found he actually knew that the payments he was authorizing were illegal, and therefore, the faulty instruction amounted to harmless error.

C. Knowledge that a Bribe Would Be Passed Along to a Foreign Official

At trial, the Court specifically instructed the jury that they can only find the defendant’s guilty if they knew – had actual knowledge– that bribe or thing of value would ultimately reach the hands of a foreign official.  The Eleventh Circuit specifically approved of this instruction.

D. Sentencing

The federal sentencing guidelines provide for a 16 level enhancement if the value of the benefit received or to be received in return for a bribe is more than $1 million but less than $2.5 million. See U.S.S.G. Section 2B1.1(b)(1). Defendants argued that this enhancement did not apply to them, individually, when the value of the benefit received by Terra (the corporation) exceeded $1 million. The Eleventh Circuit found that defendants waived this argument since they did not raise it at sentencing and, instead, argued that a lesser enhancement was warranted to maintain parity with their co-defendants who pleaded guilty.

IV. Potential Impact of the Decision

Haiti Teleco was an easy case for the court to decide since history demonstrated that the Haitian government controlled telecommunications and telecommunications was widely viewed as a service provided by the Haitian government . Undoubtedly, there will be closer cases where a more thorough application of the Esquenazi factors will be required and the two prong test outlined in Esquenazi raises several important questions:

  • Will the Department of Justice and the Securities Exchange Commission apply the factors listed in the Esquenazi two part test?
  • How will the factors listed in the Court’s two prong test impact businesses operating in certain industries, and their behavior, e.g., oil, mining, pharmaceuticals, health care, and banking?
  • Will government attorneys, or U.S. and foreign regulators treat formal declarations from a foreign government that an entity is not performing a function of that foreign government as prima facie evidence that the entity is not an instrumentality of a foreign goverment for purposes of the FCPA?
  • Does this two prong test validate the Department of Justice’s current interpretation of sovereign wealth funds (SWF’s) as “instrumentalities” of foreign governments? If so, how will this affect private investment firms’ (private equity and hedge funds) decisions to obtain investments from SWFs?

The decision also underscores the limitations of a deliberate ignorance instruction with respect to corporate executives. While Esquenazi held that the deliberate ignorance instruction was harmless error because the defendant actually knew about the illegal payments he was authorizing, the court also rejected the premise for that instruction. Indeed, the government seemed to argue that, because defendant was a corporate executive of Teleco, he should have known that the payments that he was authorizing were unlawful. Put simply, the government argued that the deliberate ignorance instruction was proper because knowledge may be imputed to the defendant based on his position as a corporate executive. Fortunately, the Eleventh Circuit recognized that, permitting a jury to find FCPA liability under this quasi-responsible corporate officer theory was problematic.

Equally as important, the decision illustrates that, if a corporate executive gives something of value, e.g. a charitable contribution, which ultimately reaches the hands of a foreign official, then the corporate executive must actually know that the contribution will reach that official to be liable under the anti-bribery provisions of the FPCA.

In sum, individuals and companies operating in high risk industries or countries with lax anti-corruption laws, or both, should be aware of the Esquenazi decision and should evaluate whether, and to what extent, the decision might impact future business arrangements and investment decisions.

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