Firm News & Legal Alerts

Sunday, April 1, 2012


The United States is currently experiencing an epidemic of diversion of lawful prescription drugs.  It is now recognized that prescription drugs are the most often abused drugs in the United States. Diversion takes place when otherwise lawful prescription drugs are “diverted” to persons for whom the drugs were not intended.  Diversion also takes place when a patient uses medications beyond the medical necessity for which they were prescribed; that is, the patient obtains and uses the drugs to satiate dependency or addiction. In addition, a provider who prescribes or otherwise obtains controlled substances for his/her own use is another unfortunate example of diversion.


In an effort to stem the tide of diversion, authorities-- including the Drug Enforcement Administration (“DEA”) and state licensing boards--are looking at the health care provider as the enabler of diversion.  The Rx is considered the launch pad for diversion and health care providers who are licensed to prescribe are now looked upon as the gatekeepers.


It is generally recognized that physicians and other health care providers licensed to prescribe, dispense and/or administer controlled substances (collectively referred to as “practitioners”) can do so without running afoul of the law.  However, instances of these practitioners being prosecuted, basically as drug dealers, are on the rise. Ever wonder why these prosecutions occur? It is because the provider has forfeited what is known as “practitioner immunity”.  This article will explore the basis of that forfeiture and how to avoid losing this protection. 


The Controlled Substances Act (“CSA”), 21 U.S.C. 801-971, and its corresponding and implementing regulations, 21 C.F.R. part 1300 et seq., mandate that the DEA prevent, detect and investigate the diversion of legally manufactured controlled substances, while at the same time ensuring that there are adequate supplies to meet the legitimate medical needs for such substances in the United States.  The controlled substances are divided into five schedules and are found at 21 C.F.R. 1308.11 through 1308.15.  The different schedules--and the placement of a drug within a particular schedule--is based on whether the controlled substance has a currently accepted medical use in treatment in the United States, as well as on the drug’s  potential for abuse and causing of dependence. 


Federal and state laws prohibit the unlawful distribution of controlled substances. For example, under federal law, 21 U.S.C. 841 makes it unlawful for any person knowingly or intentionally to manufacture, distribute or dispense, or possess with intent to manufacture, distribute or dispense, a controlled substance.  In order to be able to perform their jobs and not run afoul of these types of laws, practitioners are covered by what is loosely referred to as “practitioner immunity”; that is, they are exempt from laws prohibiting the unlawful distribution of drugs when they legitimately perform their role.  This rule is longstanding, and is contained in 21 C.F.R. 1306.04(a), which states that a prescription for a controlled substance is not effective unless it is “issued for a legitimate medical purpose by an individual practitioner in the usual course of his professional practice.” The regulation also sets forth when practitioner immunity is forfeited.  The person issuing a prescription which is not issued in the usual course of professional treatment shall be subject “to the penalties provided for violations of the provisions of law related to controlled substances.”


The United States Supreme Court reinforced and elaborated on these rules in Gonzales v. Oregon, 546 U.S. 243, (2006), stating  that “the prescription requirement … ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse.  As a corollary, it also bars doctors from peddling to patients who crave the drugs for those prohibited uses.”  These principles are also recognized by state laws. 


Accordingly, both the CSA and state laws require that controlled substances be prescribed, dispensed,  or administered by licensed practitioners only for legitimate medical purposes and only by practitioners acting in the usual course of their professional practice.  Put another way, a physician or other licensed provider can be charged with the crime of unlawful distribution for knowingly and intentionally distributing or dispensing a controlled substance other than for a legitimate medical purpose and not in the usual course of his/her practice.


The difficulty lies in determining what is a “legitimate medical purpose” and what is “in the usual course of professional practice.” The CSA and its implementing regulations do not define these terms. Basically,  these terms are linked to the concepts of medical necessity and scope of practice. The DEA and other federal and state authorities basically look to case law, state licensing board regulations, expert opinions and the medical community and its conventional practices to make these determinations.


The most fundamental factor in making this determination is whether the practitioner established and maintained a bona fide doctor-patient relationship.  In this vein, in United States v. Moore, 423 U.S. 122 (1975), the United States Supreme Court, found that a physician exceeded the bounds of professional practice, and pointed to these relevant factors in making that determination:


“…he gave inadequate physical examinations or none at all.  He ignored the results of the tests he did make. He did not give methadone at the clinic and took no precautions against its misuse and diversion. He did not regulate the dosage at all, prescribing as much and as frequently as the patient demanded. He did not charge for medical services rendered, but graduated his fee according to the number of tablets desired. In practical effect, he acted as a large-scale ‘pusher’ not as a physician.”


Some of the other principles relied upon by authorities to determine the concepts of legitimate medical purpose and the usual course of professional practice are found in additional case law.   An analytical framework,  arising out of United States v. Rosen, 582 F.2d 1032 (5th Cir. 1978), is  often used  to determine whether a practitioner has forfeited practitioner immunity.  In that case, the court found the following facts relevant:


  • 1The physician issued prescriptions to a patient known to be delivering the drugs to others;
  • 2The physician involved used street slang rather than medical terminology for the drugs prescribed;
  • 3There was no logical relationship between the drugs prescribed and treatment of the condition allegedly existing;
  • 4The physician wrote more than one prescription on occasion in order to spread them out;
  • 5No real physician-patient relationship existed with very little interaction; and
  • 6An appointment was not necessary for the patient to see the physician.


The Moore and Rosen factors shown above are not exhaustive.  There are a plethora of facts that can be looked at in determining whether a prescription was issued for a legitimate medical purpose and in the usual course of professional practice.  For example, in cases this firm has handled, we have found the following factors surfaced in the analysis and discussions with authorities:  


  • Whether a physician routinely treats chronic pain without adequate training and/or certification in pain management;
  • Whether there is an absence of objective evidence such as an MRI to corroborate the patient’s complaint of pain; 
  • Whether there is a pain management contract between physician and chronic pain patient;  
  • Whether a physician is attentive to signs of drug diversion such as negative urine screens or bogus patient excuses for early refills; 
  • Whether the physician prescribes a controlled substance for a patient's spouse or significant other without having seen the person for whom the prescription was prescribed; 
  • Whether there exists a pattern and practice of violating DEA and/or state licensing Board regulations regarding the prescribing, dispensing, and administering of controlled substances;
  •  Whether patients traveled an inordinate distance to the physician; 
  • Whether the physician’s office and practice had features and appearance consistent with a “pill mill”;  and 
  • Whether the patient visit has the trappings of a legitimate “doctor visit” or was a perfunctory, sham visit (the bogus nature of the visit is exposed on undercover videotape).  


These cases all hinge on their individual facts and thus “are fact dispositive.” Simply put, the more facts on the wrong side of the ledger, the more likely a determination that “practitioner immunity” was forfeited and that the practitioner should be charged criminally. Put another way, the more bonafide the practitioner-patient relationship and the more medical necessity truly and accurately demonstrated in the patient medical records, the less likely a criminal charge will even be considered.


Needless to say the penalties for a conviction are severe, with a potential term of imprisonment and hefty monetary penalties, and are also almost always a career terminator. Under federal law the penalty would vary depending on the nature and aggregate quantity of the controlled substance, whether death or serious bodily injury resulted to anyone, and the total offense level calculation under the Federal Sentencing Guidelines.  If charged instead at the State level, practitioners will also face severe penalties there as well.


Whenever criminal charges ensue, administrative sanctions also follow.  Moreover, one must keep in mind that even when an investigation does not result in criminal charges, administrative sanctions are not precluded and can be just as crippling to a medical career. For example, when a physician is the subject of a diversion investigation, and criminal charges are not filed, one can still expect administrative action from the DEA to revoke a practitioner’s DEA registration and also disciplinary action from the applicable state licensing board. 


The bottom line is physicians and all providers licensed to prescribe must establish and maintain a bonafide provider-patient relationship. Practitioners must also be cognizant of DEA regulations and requirements for prescribing, dispensing, and administering controlled substances, as well as their own state licensing board regulations which usually mirror, or at least will follow closely, the DEA regulations. They must also pay particular attention to the rules pertaining to Schedule II controlled substances, and should be reluctant to treat chronic pain without a certification or specialty in pain management. The physician should also be aware of other physicians qualified in the area qualified to treat chronic pain, for purposes of patient referrals when necessary.


In treating pain patients, the physician should employee best practices.  They must know the rules for treating acute pain vs. chronic pain.  They must refrain from becoming too compliant to their patients’ wishes and demands.  They must be attentive to the common sense signs and “red flags” of diversion and dependency/addiction. Seek guidance from like professionals and legal advice when appropriate.  For the provider who is diverting to his/her own use, immediate enrollment in a substance abuse program tailored to the needs of the medical community, such as the Professional Assistance Program of New Jersey, as well as seeking immediate legal advice from an attorney in a legitimate attorney-client relationship, are immediate steps necessary to saving a career.




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