In the last few years, there has been a dramatic increase in state and federal prosecutions of medical doctors for improper or illegal drug prescribing practices. Most of these cases involve pain management clinics over prescribing Schedule II drugs. Often, the predominate drug prescribed at these clinics, and the drug which precipitated the investigation is OxyContin.
The FDA approved OxyContin in the mid 1990’s for moderate to severe pain. It contains a time-release mechanism which when the pill is taken as prescribed produces up to twelve hours of pain relief. However, when ground up, snorted or injected, it provides an immediate morphine-like high. As a result, OxyContin is now the drug of choice for serious drug addicts. In addition, many patients who were prescribed for acute pain such as post surgery have become addicted.
The primary criminal vehicle used by federal prosecutors is the Federal Controlled Substance Act.1Section 1306.04 of the Code of Federal Regulations (the regulations which interpret the Controlled Substance Act) provides that a “prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his practice”. These criminal cases allege that the physician did not issue a valid prescription for a scheduled drug, in violation of the Controlled Substance Act, which contains very serious criminal penalties. Many states have also passed controlled substances acts, and/or have adopted the Uniform Controlled Substance Act of 1994.2
Some of these cases come down to experts arguing over whether prescriptions where issued for a valid medical purpose. However, government investigators try to circumvent this problem by using undercover agents who attempt to secure prescriptions without a valid medical purpose. The problem is that rarely will an undercover agent come out and say he/she is a drug abuser or reseller and needs the drugs. They are much subtler and will often use vague and generalized statements about pain or anxiety or inability to sleep. These vague statements can sometimes form the basis of a defense.
If the physician prescribes schedule II drugs without following an appropriate protocol, the government will usually file some kind of case. If the evidence is not strong, or it appears that the physician is simply not acting consistent with the standard of care for prescribing controlled substances, a civil case will be filed. Under the terms of the statute, each prescription written without a legitimate medical purpose carries a maximum fine of $25,000. Most of these civil cases settle before trial, and indeed, depending on the case, they often settle before a federal civil lawsuit is filed. If one or more patients have died as a result of overdoses of OxyContin or similar drugs, usually will cause the case will go criminal. Indeed, recently, several doctors have been indicted on state homicide charges arising from the overdosing death of patients.
Another factor that influences the government’s criminal verses civil decision is whether the clinic accepts federal or state reimbursement. Clinics that accept Medicare or Medicaid and have engaged in consistent overprescribing are more likely to face criminal charges and will usually see heath care fraud charges included in an indictment.
Any criminal conviction or plea, and often civil settlements will result in licensure action by the practitioner’s state board.
There are a few red flags that the prosecutors look for in overprescribing cases. The primary characteristic of an illegal prescription mill is the failure to adhere to pain management protocols, and the practice of what is called “good faith” prescribing, which is where there is neither objective findings supporting the prescription nor adequate documentation of the condition or injury causing the need for the medication. Another factor the government looks at is whether the physician is prescribing more than one Schedule II drug at a time.3
The best way avoid problems in this area is to adhere to the pain management guidelines in your state, or if there are none, the general pain management guidelines. Essentially, all of these guidelines have most of the following required elements:
1. An adequate and documented evaluation of the patient;
2. A written treatment plan;
3. Documented informed consent
4. Periodic review
5. Consultation with other appropriate heath care practitioners
6. Accurate and complete medical records
7. Compliance with state and federal controlled substance laws and regulations.4
I have handled a number of drug prescribing cases, including cases involving the recommendation of medical marajuana.
1 For the text of the Act, go to http://www.usdoj.gov/dea/agency/csa.htm
2 The Uniform Act can be found at http://www.law.upenn.edu/bll/ulc/fnact99/1990s/ucsa94.htm
3 The federal authorities have recently tried to clarify its position on this issue. Seehttp://www.medsch.wisc.edu/painpolicy/domestic/DEA_Rx.pdf. However, it is unlikely that this issue will end litigation on this point.
4 The Model Guidelines for the Use of Controlled Substances for the Treatment of Pain issued can be viewed at http://www.medsch.wisc.edu/painpolicy/domestic/model.htm. The Pain and Policy Group of the University of Wisconsin has an excellent website dealing with many aspects of pain management and various guidelines. http://www.medsch.wisc.edu/painpolicy/index.htm