We have seen more investigations of physicians or advanced practitioners (physician assistants and nurse practitioners) prescribing phentermine to patients. Phentermine is a Schedule IV drug and we have seen increased scrutiny of weight loss clinics and investigations into the physicians, nurse practitioners, physician assistants and nurses who work at them.
The investigations include the following topics:
1. The business structure of the weight loss clinics and whether management companies or non-physicians are involved in the business.
2. Whether the physician established a bona-fide doctor-patient relationship before prescribing phentermine to patients.
3. Whether the physician obtained a thorough history or complete a thorough physical examination prior to initiating treatment utilizing a Schedule IV controlled substance.
4. Whether the physician continued prescribing phentermine to a patient who had failed to lose weight after taking the controlled substances over a period of thirty days.
5. Whether the physician had initiated treatment utilizing a Schedule IV controlled substance without having performed a review of the patient's prior medical and weight-loss program records to determine that the patient had made a substantial good-faith effort to lose weight in a treatment program utilizing a regimen of weight reduction based on caloric restriction, nutritional counseling, behavior modification and exercise, without the utilization of controlled substances, and that said treatment had been ineffective.
6. Whether physician had dispensed drugs having addiction-forming or addiction-sustaining liability otherwise than in the course of legitimate professional practice.
7. Whether the physician had violated 21 C.F.R. Section 1306.04(a) which requires that a controlled-substance prescription "be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice."
8. Whether the phentermine is being properly stored and dispensed under state and federal rules. Are the DEA logs maintained properly? Is the receptionist or a medical assistant improperly handing the phentermine to the patients? Is the phentermine properly labeled with instructions?
9. Are referral fees given to patients for referring friends in violation of state anti-kickback and referral fee rules?
10. Is the phentermine being given at a discount if private or government insurance is billed for other services?
We handled one case outside of California where law enforcement sent in a confidential informant to gather information on the physician’s weight loss practice. The government informant was female, short and weighed over 210 pounds at the time of her initial visit to the practice and it was obvious that law enforcement chose her to participate in the investigation because she was not only obese, but had a number of other medical conditions as well.
In that case, the physician was investigated for prescribing phentermine (controlled substances) to the undercover without performing an adequate physical examination, properly documenting her medical history, recording adiposity measurements such as BMI or waist circumference, conducting any laboratory testing, or verifying that the undercover had made good faith efforts to lose weight without the aid of controlled substances. We helped obtain the dismissal of criminal charges but the DEA and Medical Board still pursued the physician.
If you have medical weight loss as part of your practice, now is the time to get compliant with state and federal rules and regulations -- before there is an an investigation. Have us or another experienced firm conduct an audit and make sure you comply before the Medical Board or DEA pays your office a visit or requests records from your office. If there is an investigation, get counsel right away so you do not respond to records requests or interview requests without representation.
Posted by Tracy Green, Esq.
Green and Associates, Attorneys at Law