Health Care Fraud: Recent Developments and Timeless Advice

By Robert S. Bennett and David M. Medearis 

Abstract

Health care fraud has gained increased attention at both the state and federal levels in recent years. The $875 million criminal settlement by TAP Pharmaceutical Products, Inc, in October 2001 and subsequent indictments of physicians involved with the alleged HCA Medicare fraud conspiracy highlight the fact that physicians who are unaware of any wrongdoing may get dragged into the government's battle. The various laws and overlapping enforcement agencies can be complex and daunting to a physician who is falsely accused. This article provides a brief overview of three relevant federal health care fraud statutes: the Prescription Drug Marketing Act, the Medicaid Anti-Kickback Statute, and the False Claims Act. The article also briefly discusses the Texas Medicaid Fraud Prevention Act and the roles of various state agencies responsible for the detection and prevention of health care fraud. Finally, the article provides practical advice about the investigative process and what every prudent physician should do if under investigation.

Introduction

The federal government estimates that health care fraud costs Medicaid and Medicare $10 billion annually.¹ Given the government's current efforts to cut health care spending, the US attorney general's recent statement that the detection and prevention of health care fraud is one of the government's top priorities is not surprising.² While enforcement agencies have been aggressively pursuing fraud in a number of areas, the relationship between physicians and pharmaceutical representatives has drawn a great deal of attention. According to Health and Human Services (HHS) Inspector General Janet Rehnquist, "[i]n recent years, the pharmaceutical industry has come under increasing scrutiny for its pricing, sales, and marketing practices."² 

A number of cases relating to this issue have made headlines in recent years. Last year, TAP Pharmaceutical Products, Inc, paid the government $875 million to resolve allegations that the company had bribed physicians, conspired with physicians to submit false claims to Medicare and Medicaid, and conspired with physicians to sell drug samples in violation of the Prescription Drug Marketing Act. At that time, the government boasted that the TAP settlement was the largest criminal fine ever paid in a health care fraud prosecution.³ Immediately following its settlement with TAP, the Department of Justice (DOJ) began looking into the activities of specific physicians in Texas and across the country in connection with their involvement with TAP and other pharmaceutical companies. To date, at least 5 physicians and 14 former TAP employees have faced criminal charges in connection with this controversy, and most have plead guilty.⁴

Several weeks following the TAP indictments, a former pharmaceutical sales representative of the Parke-Davis division of Warner-Lambert Company alleged that Parke-Davis officials also were engaged in illegal marketing activities in connection with their company's epilepsy drug, Neurontin.⁵ And in January 2002, the General Accounting Office requested detailed sales and pricing data from 11 major drug manufacturers, going so far as to issue a subpoena to Pfizer.⁶ Last May, Schering-Plough Corporation announced that it had received a "target letter" from the government indicating that it was under a grand jury investigation for marketing activities similar to those alleged in the TAP case.⁷ The US Attorney's Office in Boston, which handled the TAP case last year, is now handling the case against Schering-Plough. The Boston unit -- whose special health care fraud unit leads the nation in health care fraud recoveries -- says it is currently expecting settlements from Schering-Plough and Pfizer for fraudulent marketing activities.⁸ It is also investigating similar activities of Bristol-Myers Squibb and AstraZeneca.⁸ 

Why should physicians be concerned about these actions? HHS recently issued a statement to pharmaceutical companies regarding their interactions with physicians, cautioning drug makers about "problem areas," including excessive payments for physician consulting and research services, and entertainment, recreation, travel, meals, gifts, gratuities, and other business courtesies provided for physicians.⁹ Physicians should be extremely cautious in their business dealings and interactions with pharmaceutical representatives. Innocent mistakes -- whether made in the ordinary course of business or in the course of a government investigation -- can result in major legal problems. 

Consider the fate of the two former executives of HCA Inc, the nation's largest hospital owner, who were caught in the government's crosshairs in connection with a Medicare reimbursement dispute between the government and HCA Inc. The two executives were convicted in 1999 of Medicare fraud and sentenced to 2 and 3 years imprisonment.¹⁰ Their convictions were eventually reversed, but nearly 4 years of court battles elapsed before a federal circuit court in Florida held that "competing interpretations of the applicable law are far too reasonable to justify these convictions."¹¹ 

Genuine health care fraud is a serious problem. But another problem may be surfacing: individuals without any fraudulent intent simply make mistakes and are prosecuted by overzealous federal prosecutors. As one legal scholar puts it, "care should be taken so that the mystique of the health care fraud law enforcement machine does not seduce the regulator into becoming a hunter when there is no prey."¹² 

This recent scrutiny of health care providers has emerged from what was previously a relatively lax environment. As a result, it is focusing on many physicians who may have made mistakes without intending to do anything dishonest or illegal. This article provides a brief overview of three relevant federal health care fraud statutes: the Prescription Drug Marketing Act (PDMA), the Medicaid Anti-Kickback Statute, and the False Claims Act (FCA). Also provided is a brief overview of the relevant enforcement agencies and some timeless advice on governmental investigations and how to survive them. 

Prescription Drug Marketing Act

The Prescription Drug Marketing Act (PDMA) prohibits the sale or trade of drug samples.¹³ A "drug sample" is defined by the act as a unit of drug that is "not intended to be sold and is intended to promote the sale of the drug." Violation of the PDMA can result in up to 10 years imprisonment and fines of up to $250,000.¹⁴ Congress enacted the PDMA to prevent "an unacceptable risk that counterfeit, adulterated, misbranded, subpotent or expired drugs" could be sold to American consumers.¹⁵ The act was intended to correct the "decades of abuse" by unscrupulous individuals who repackage, distribute, and sell sample drugs.¹⁶ The abuse described in the legislative history involves intricate underground black markets in which free samples are repackaged and sold to unsuspecting consumers.¹⁷ This process often results in misbranded and adulterated products. 

Although the violation of the PDMA was a central allegation in last year's TAP settlement, the application of the PDMA seems misplaced in this instance. The allegation was that physicians were given free units of TAP's cancer drug, Lupron, as an inducement for them to prescribe Lupron. The physicians were then encouraged to bill the free units as regular units. The "drug samples" were packaged, stored, and administered by physicians in exactly the same manner as any other drug units would have been. Some physicians accused of wrongdoing in the TAP controversy have indicated that the so-called "drug samples" they received were provided as replacement units for damaged shipments and were not labeled as "Free Sample" or "Not Intended for Resale." Under these circumstances, concluding that these units were "drug samples" as defined by the PDMA seems unreasonable.

Nevertheless, the government claims that some physicians who billed patients for drug units delivered to them by pharmaceutical representatives made illegal sales prohibited by the PDMA. An Indiana urologist, Rodney Mannion, MD, 71, who plead guilty to violations of the PDMA in a plea agreement connected with the TAP investigation, was sentenced to 3 years probation and was fined $2,000.¹⁸ The US Attorney's Office reportedly recommended a light sentence because Dr Mannion cooperated in providing evidence to the government in its case against TAP. Dr Mannion's plea agreement also involved the government dropping other charges of health care fraud covered by the Medicaid Anti-Kickback Statute and the Federal False Claims Act.  

Medicaid Anti-Kickback Statute

The thrust of the government's allegations in the TAP case was that TAP pharmaceutical sales representatives and certain health care providers conspired to violate the federal Medicaid Anti-Kickback Statute.¹⁹ The Anti-Kickback Statute prohibits knowingly and willfully paying or receiving any remuneration directly or indirectly, overtly or covertly, in cash or kind, in exchange for prescribing, purchasing, or recommending any service, treatment, or item for which payment will be made by Medicare, Medicaid, or any other federally funded health care program.¹⁹ To convict a health care provider under the Anti-Kickback Statute, the government must prove that he or she solicited or received remuneration, the remuneration induced a referral related to a government program, and the transaction was knowingly and willfully entered into by the accused. Violations of the Anti-Kickback Statute are punishable by fines of up to $25,000 or 5 years imprisonment or both for each incident.²⁰ 

The broad scope of the Anti-Kickback Statue prohibits not only obvious illegal actions, such as kickbacks and bribes, but also an array of complex economic relationships that could result in conflicting interests, including discount arrangements, incentives given to providers, payments for services, and the practices of manufacturers giving gifts and other business courtesies.²¹ The danger of this broad language is that virtually anything a physician receives from a pharmaceutical company could be swept into the statute's prohibition. Last year, in response to the growing concern over kickback activities or allegations, the Pharmaceutical Researchers and Manufacturers of America (PhARMA) proposed a voluntary code that pharmaceutical companies are expected to follow when interacting with health care providers.²² The new code, consistent with the spirit of the current climate, prohibits even the age-old practice of sales representatives dropping off a pizza or donuts at a physician's office. Although compliance with the PhARMA code is voluntary, HHS issued a warning to the pharmaceutical industry in April to follow this code.⁹ 

The American Medical Association's Ethical Opinion on Gifts to Physicians from Industry is straightforward. Adherence to the AMA guidelines should be sufficient to avoid allegations of kickback activities. Basically, AMA advises physicians to only accept gifts of minimum value that primarily benefit patients, such as textbooks and other educational materials, and to not accept cash gifts or free drug samples for personal use. Conferences or meetings should be dedicated primarily to scientific and educational activities, and faculty should accept only reasonable honoraria and reimbursement for expenses when participating in industry-sponsored educational conferences. Physicians attending conferences should not accept payment or reimbursement for the cost of travel, lodging, or other personal expenses. Only students, residents, or fellows should accept industry support for attending conferences. And, of course, no gifts with strings attached should ever be accepted.

Although physicians should always try to remain on the safe side when interacting with pharmaceutical sales representatives or making arrangements with clinical laboratory services, hospitals, or other business or joint venture arrangements, actual conviction under the Anti-Kickback Statute requires the government to show that a defendant acted with specific intent, ie, "knowingly and willfully." This culpability requirement, which was added to the Anti-Kickback Statute in 1980, was intended by Congress to prevent what was viewed by many as unjustified prosecution of individuals who acted improperly but inadvertently.²³ 

The federal indictment of TAP pharmaceutical employees alleged that TAP representatives, from 1989 to October 2001, engaged in the practice of inducing physicians to purchase and prescribe Lupron instead of other drugs by offering and providing "money, free and nominally priced drugs, discounted prices on one drug to induce prescription of the other, free consulting services, and other things of value."²⁴ A unique aspect of the TAP case is the notion that free drug samples can be turned into cash kickbacks. In this respect, the TAP case illustrates a broader application of the Anti-Kickback Statute: the economic arrangement involved indirect kickbacks, in which free samples or nominally priced drugs are "turned" into cash kickbacks. This indirect nature of the alleged kickbacks increases the likelihood that the defendant did not knowingly and willfully violate the law. 

Some of the physicians accused of billing for free samples in the TAP case did not even know that the drug units provided to them by TAP representatives were actually drug samples. As mentioned in the previous section, many of the so-called drug samples involved in the TAP case were identical to regular units, not marked as free samples, and were delivered under the pretense of replacement units. Furthermore, even in the government's own allegations against TAP, the government stated that TAP representatives forged physician signatures on sample request forms. Thus, physicians may have received and billed for free samples without knowingly and willfully doing so. This lack of intent is an excellent defense and should be raised as early as possible in an investigation. This type of defense is precisely the kind of protection Congress intended by adding a specific intent requirement to the Anti-Kickback Statute in 1980.²³ 

The 9th Circuit Court of Appeals recently construed the "knowingly and willfully" requirement of the Anti-Kickback Statute as requiring a defendant to "(1) know that § 1128B prohibits offering or paying remuneration to induce referrals, and (2) engage in prohibited conduct with the specific intent to disobey the law"²⁵ (emphasis added). Moreover, the 5th Circuit Court of Appeals (of which Texas is a member) recently adopted the 9th Circuit's interpretation of the "knowingly and willfully" requirement under the Anti-Kickback Statute.²⁶ This interpretation of the Anti-Kickback Statute's "knowingly and willfully" requirement may provide a legitimate defense to physicians who simply were not aware that they were breaking the law. Of course, no one wants to be placed in this position, but to some extent, "ignorance of the law" might be the only defense.  

False Claims Act

The False Claims Act (FCA) provides that when persons submit, cause others to submit, or conspire to submit false or fraudulent claims to the US government, including its federal health care programs, the government is entitled to treble damages (ie, three times the amount billed), plus fines of $5,500 to $11,000 for each false or fraudulent claim submitted.²⁷ FCA actions can be brought against any government contractor directly by the government or by private citizens. Qui tam provisions of the FCA allow private citizens to file a suit in the name of the US government charging fraud, and reward the individual who files the suit with a share of any money recovered.²⁷ ("Qui tam" is derived from old English law meaning "one who sues on behalf of the king as well as for himself.")

To prevail in suit under the FCA, the government must show that (1) the physician made, or caused to be made, a statement of material fact in an application for payment or benefits under a federal health care program; (2) the statement or representation was false; (3) the physician knowingly and willfully made the statement; and (4) the physician knew the statement to be false.²⁸ The court will also consider factors such as whether the accused was on notice of the governing rule or policy, the clarity of the rule or policy, the pervasiveness and magnitude of the false claims, the existence of a compliance program, the physician's past efforts to remedy the problem, whether the physician previously received guidance on the issue, and the results of previous audits.²⁹

The FCA provides rewards for whistleblowers of up to 15% of the government's recovery, providing a rich incentive for any current or past employee to become a whistleblower and spark a governmental investigation. The current investigations regarding TAP and Parke-Davis are examples of this behavior. Former TAP sales executive Douglas Durand received a $77 million whistleblower payment for reporting TAP's activities.³⁰ 

Administrative Actions

While the DOJ generally prosecutes federal health care crimes, the Department of Health and Humans Services Office of Inspector General (OIG) also pursues administrative and civil penalties against violators of the Medicaid Anti-Kickback Statute, the False Claims Act, or any other violations that endanger Medicaid beneficiaries. Administrative and civil remedies through the OIG offer the government an advantage of more favorable discovery rules and a lower standard of proof. In some instances, the DOJ may refer cases to the OIG to proceed administratively. A physician may feel some relief when this happens; however, administrative proceedings by the OIG are by no means to be taken lightly because fines can be exorbitant and exclusion can be a professional death sentence.

Physicians who are convicted of or plead guilty to a "criminal offense related to such physician's or practitioner's involvement in the Medicare and Medicaid programs" face mandatory exclusion for at least 5 years.³¹ However, the OIG may also permissively exclude providers who have not been criminally convicted, provided the excluded provider or entity is given reasonable notice and opportunity for a hearing by the secretary of the Department of Health and Human Services and to judicial review of the secretary's final decision.³² 

In addition, the HHS secretary can temporarily withhold payments from Medicaid and Medicare to an individual or entity before reaching a final decision.³³ This can create a significant burden for a physician to overcome if he or she is dependant on government funds to stay in business. In this situation, the physician is without recourse, and the courts have upheld this withholding by denying preliminary injunctions to "temporarily excluded" providers.³⁴  

The effects of exclusion to an individual or entity are harsh. First, the individual or entity is excluded from receiving program payments for items or services furnished, ordered, or prescribed under Medicare (Title XVIII), Medicaid (Title XIX), Maternal and Child Health Services Block Grant (Title V), Block Grants to States for Social Services (Title XX), State Children's Health Insurance (Title XXI), and all other federal health care programs.³⁵ Moreover, any entity in which an excluded individual is serving as an employee, administrator, operator, or in any other capacity for any services, including administrative and management services furnished, ordered, or prescribed during the period of exclusion, is also subject to exclusion.³⁵ Furthermore, no payment will be made to any entity that submits bills for payment of items or services provided by an excluded party.³⁵ The effect of exclusion is so harsh it is often thought of as an administrative death sentence. Nevertheless, in fiscal year 2002, the OIG excluded 3448 providers.³⁶ 

State Actions: Texas Medicaid Fraud Prevention Act

State and federal law enforcement authorities generally work together to oversee Medicaid compliance. For the most part, the Texas Medicaid Fraud Prevention Act (TMFPA) mirrors federal health care fraud laws. Texas law grants the Texas Attorney General broad authority to impose monetary and administrative sanctions.³⁷ Like the Federal False Claims Act, the TMFPA has a qui tam provision to reward whistleblowers.³⁷ The Texas Attorney General has established the Medicaid Fraud Control Unit (MFCU), the Texas Health and Human Services Commission's Medicaid Program Integrity Department (MPI), and the Elder Law and Public Health Division (ELPH) to investigate and prevent health care fraud and abuse. 

The MFCU conducts criminal investigations into potential violations of state and federal Medicaid laws and other related misconduct of physicians. The MPI, like the OIG at the federal level, has the authority to impose civil and administrative sanctions on physicians, including (1) exclusion from Medicare and Medicaid programs for a specified period of time; (2) suspension of payments; (3) recoupment of overpayments; (4) recoupment of projected overpayments (determined through a sampling process); (5) restricted reimbursement; and (6) civil monetary penalties. Finally, the ELPH investigates abuse of the elderly and inspects nursing homes. The ELPH also has authority to investigate and prosecute civil Medicaid fraud claims and may also refer cases to MFCU for criminal prosecution.³⁸

What Should You Do If You Are Under Investigation?

Most health care providers never think they will be investigated until agents arrive at their office unannounced and begin asking questions and making demands; then, panic ensues. Often, teams of government lawyers and agents will attempt to catch a potential target off guard with unannounced visits to the target's home. These surprise visits provide the government with a substantial psychological advantage, as most individuals do not fully understand their legal rights and obligations, and, consequently, may consent to an interview without having all the facts. This can prove disastrous: statements may be misconstrued or denials could lead to additional charges for lying to federal agents or for obstruction of justice. The recent securities fraud indictment of Martha Stewart is a perfect example. The government's insider trading charges against Ms Stewart were weak; thus, the emphasis of the case against her has turned to three counts of false statements made by Ms Stewart to federal agents, a conspiracy charge, and a charge of obstructing justice. Ultimately, Ms Stewart may face convictions for a "cover-up" of a crime that the government cannot even prove she committed. 

This recent case is a clear example of why you should not speak to agents until you have consulted with counsel. Even if you are absolutely certain you have done nothing wrong, you should heed this advice. You may not have all the facts or may not be clear about the applicable law. On the other hand, you should tell your legal counsel everything. Because dealing with federal investigators can be like walking on eggshells, your counsel must have all of the facts before speaking with investigators. The balance between telling investigators too much and running the risk of lying or obstructing justice is a delicate one. Moreover, saying the wrong thing can also refresh the statute of limitations on a transaction that otherwise would have been outside the scope of criminal prosecution. 

In some instances, government agents may appear at your office or home and request documents. You must remain calm, professional, and polite, but at the same time, stay on guard and act prudently. If the agents wish to search or to obtain records, the first thing you should do is to identify the agent in charge and ask to read the documents authorizing the search. These documents will usually be a request for medical records, a subpoena (usually from the OIG), or a search warrant. Your rights and consequently the rules the government agents must follow are different, depending on what type of document authorizes the search. If the agents' authorization is a request for records or an agency subpoena, the agents are generally not entitled to immediate access or entry. On the other hand, if they present a search warrant issued by a judge or magistrate, they are entitled to immediate entry and access to your records. Regardless of what they present, you do not (and should not) have to answer questions without an attorney present.

If the agents do not present a search warrant or if for some reason you believe the warrant is invalid, you should first assure the agents of your willingness to cooperate. Then, point out that because you do not believe the documents authorize an immediate search, you would like to wait for your attorney to arrive to assist the agents with gathering the appropriate documents. Most agents will agree to wait for your attorney. If they indeed do not have a valid search warrant and still insist on immediate access, trying to stop them is generally unwise. In this case, you should maintain, preferably in front of witnesses, that you are allowing them to search under protest, and then call your attorney immediately.

If the agents do present a search warrant, you may ask if they would wait for your counsel to arrive; generally, they will not grant such a request without a good reason to do so. Under no circumstances should you interfere with or intimidate agents. Such conduct may lead to fines or imprisonment for obstruction of justice.

While you should not interfere with agents conducting a search, you should monitor the search. Your attorney may not be able to arrive before the agents begin the search. Nonetheless, he or she should arrive as soon as possible to help monitor the search or at the very least interview everyone who witnessed the search as soon as possible while memories are still fresh. If your attorney is not available, you must play an active role in monitoring how the agents conduct the search. In monitoring the search, you should record the names of each agent and document the search as best as possible. 

Ideally, you should assign an employee to each agent conducting the search. If a camera is available, document the search on film. Persons monitoring the search must not interfere with the agents. However, if certain documents go beyond the scope of the agents' warrant or if you believe they are privileged documents, record your objection and request that the said documents be boxed separately and marked "privilege claim asserted." The company representative monitoring the search should also arrange to make copies of all documents or computer files taken by agents and make a detailed inventory of all items taken. Although the agent in charge is required to provide you with an inventory, do not rely on this; agents typically provide only a general list, which is not very helpful.

Proper monitoring of the search provides several advantages. First, a detailed record of the search provides your counsel with valuable information necessary to provide the best defense or recommend a settlement of plea offer, whichever the case may be. Second, monitoring the search also helps to prevent agents from taking critical documents without leaving you copies. Furthermore, documents obtained in areas or by means that exceed the scope of the agents' authorization may be deemed inadmissible evidence if your case goes to trial.

Conclusion

As health care expenditures continue to rise, the entire health care industry will inevitably face greater political pressures and legal scrutiny over these rising costs. Increased scrutiny of prescription drug costs has attracted particular interest recently, as this sector represents the fastest growing health care costs in terms of overall expenditures.³⁹ Health care organizations and providers should focus on strict compliance with applicable laws, particularly with respect to billing transactions and business relationships that might be construed as unethical arrangements to generate Medicaid business. Deals that seem too good to be true may be illegal.

The Medicaid Anti-Kickback Statute, the Prescription Drug Marketing Act, and the False Claims Act are but a few of the serious fraud-and-abuse provisions that can destroy a health care organization or the career of an uninformed health care provider. Unfortunately, physicians must adhere to literally 100,000 pages of Medicare regulations, rulings, and bulletins. Criminal charges can be brought at either the state or federal level. Civil and administrative proceedings also can have serious consequences. However, the goal should always be to err on the safe side to avoid exhausting investigations and serious charges that can be devastating. You do not want to spend a small fortune in legal fees and 5 or 6 years of your life trying to prove your innocence.

References

1.      Adams M. LOA offers presentation on Medicaid, Medicare fraud. Roanoke Times & World News. May 15, 2003: 56.

2.      BNA Health Care Daily. August 14, 1997; d3.

3.      United States Department of Justice. Dallas Resident Sentenced to 10 Years Imprisonment for Operating Health Care Fraud Scheme. Press release; May 24, 2002. Available at http://www.usdoj.gov/usao/txn/PressRel02/flemons_sen_pr.html. Accessed July 21, 2003.

4.      Japsen B. US charges 6 more in TAP cancer drug marketing. Chicago Tribune. July 17, 2002: 1. See also Murphy S. Gifts seen effective by drug company reps. Boston Globe. November 17, 2002.

5.      Greene J. Former drug rep slams off-label claims, AMNews. October 22/29, 2001. Available at: www.ama-assn.org/sci-pubs/amnews/pick_01/prsd1022.htm. Accessed July 23, 2003.

6.       Hensley S, Adams C. Pfizer confirms it received subpoena from GAO seeking drug-price data. The Wall Street Journal. January 9, 2002: B10.

7.      Rowland C. US widens drug firm inquiry: Schering-Plough faces criminal investigation. Boston Globe. May 31, 2003: C1. 

8.      Health care fraud: US prosecutors in Boston examined. Washington, DC: American Health Line; May 13, 2003.

9.      Pharma Marketletter. US HHS compliance guide tells firms: stick to PhRMA Code in dealings with doctors. London, England: Marketletter (Publications) Ltd; May 5, 2003. 

10.    HCA: court dismisses convictions of two former officials. Washington, DC: American Health Line; March 25, 2002.

11.    United States v Whiteside. 285 F 3d 1345 (11th Cir 2002).

12.    Bucy PH. Symposium: The path from regulator to hunter: the exercise of prosecutory discretion in the investigation of physicians at teaching hospitals. St Louis L J. 2000;44:3.

13.    21 USC § 353[c](1).

14.    21 USC § 333.

15.    24 Weekly Comp Pres Doc 519 (April 25, 1988).

16.    HR Rep No. 76, 100th Congress, 1st Sess 11 (1987).

17.    59 Federal Register at 11,854.

18.    PR Newswire Association, Inc. Indiana urologist sentenced for health care fraud, reports US attorney. June 3, 2002.

19.    42 USCS 1320a-7b; United States of America v. MacKenzie. Grand jury indictment, US District Court, District of Massachusetts. 

20.    42 USC § 1320a-7b(a)(6).

21.    Blair DA. The "knowingly and willfully" continuum of the Anti-Kickback Statute's scienter requirement: its origins, complexities, and most recent judicial developments. Annals of Health Law. 1999;8:1,2,6.

22.    PhRMA adopts new marketing code. News release. April 19, 2002 Available at : http://www.phrma.org/mediaroom/press/releases/19.04.2002.390.cfm. Accessed July 22, 2003.

23.    HR Rep No 96-1167, at 59 (1980), reprinted in 1980 USCCAN 5526, 5572.

24.    United States of America v MacKenzie. Grand jury indictment. US District Court, District of Massachusetts, at 2.

25.    See Hanlester Network v Shalala, 51 F 3d 1390, 1400 (9th Cir 1995).

26.    See United States v Davis, 132 F 3d 1092 (5th Cir 1998).

27.    31 USC § 3729; see also 42 USC § 1320a-7b.

28.    See Young-Montenay, Inc v United States, 15 F 3d 1040, 1043 (Fed Cir 1994).

29.    Holder EC Jr. Guidance on the use of the False Claims Act in civil health care matters (June 3, 1998). Available at: http://www.usdoj.gov/04foia/readingrooms/chcm.htm. Accessed July 22, 2003.

30.    Greising D. Think about it: whistle blowing not easy money. Chicago Tribune; October 7, 2001. Available at: http://chicagotribune.com. Accessed July 22, 2003.

31.    See Greene v Sullivan, 731 F Supp 835, 837 (ED Tenn 1990).

32.    42 USCS § 1320a-7(f)(1).

33.    42 CFR § 405.371(b). 

34.    See, eg, Neurological Associates-H., et al v Bowen, 658 F Supp 468 (SD Fla 1987).

35.    HHS Office of Inspector General. About the OIG Exclusion Program. Available at: http://oig.hhs.gov/fraud/exclusions/aboutexclusions.html. Accessed July 22, 2003.

36.    HHS Office of Inspector General semiannual report to the Congress. April!!-September 2002; Highlight Section: page v.

37.    Clark JE. Texas Medicaid Fraud Prevention Statute: Sharp, new teeth for the state and cash rewards for relators exposing wrongdoers. Texas Bar Journal. 2002;65:120.

38.    Tex Gov Code. §§ 531.103 & 531.104.

39.    US Health care spending up 6.9% to $1.3 trillion in 2000. Dow Jones Newswires; January 8, 2000.

Published in Texas Medicine, October 2003 (reprinted by permission of the Texas Medical Association)