| June 5, 2012
Two DEA representatives met with us today to audit one of our physicians in my private group practice as a result of our being authorized under DATA-2000 to prescribe drugs for the maintenance treatment of opioid dependence. The meeting went smoothly and took well under one hour. This was the first time the DEA met with any of us.
Under DATA 2000, physicians are authorized to prescribe to either 30 or 100 patients depending upon their qualifications. Using the 100 patient mark as a standard, it is important to recognize that the limitation applies to the physician, not to the facility. So if you prescribe to 50 patients at Facility A, you can prescribe to only 50 more at Facility B. Each physician as a result must maintain his or her own list of patients to be certain that the limitation is not exceeded. The DEA will call upon you at the address where you are registered (the address on your DEA certificate), so that is the location where you should have all your records pertaining to buprenorphine prescribing.
How does one count a patient? We use a spreadsheet that we update each time we issue a prescription. The spreadsheet calculates the end-date of the prescription, thus any patient with an active prescription counts toward the limit. If the prescription has run out, even if the patient is still counted as a patient in the office, the patient does not count toward the limit. At the end of each month, we print two hard copies of the spreadsheet identifying the total count per physician. One hard copy, for our records, includes the name of the patient. The other, for the DEA, includes only an identifying number.
So when the DEA agents asked to see our records for the last three months, we showed them the last three printouts with the names stripped off. Each line of the spreadsheet displayed the patient ID, the prescribed medication, the dose prescribed, and the expiration date of the prescription. The agents shared that this was precisely what they needed to see. They looked over the records for a few minutes, did not take them, and did not ask to look at any medical records. They noted that sometimes they request information covering the last two years of prescribing, so it would be best to maintain this type of information for at least that long.
We have a special Informed Consent form specifically for patients to be prescribed buprenorphine. The agents asked how we provide informed consent, and this document was shared with them.
The agents asked about the dosage of buprenorphine that we prescribe. We use 16mg as our maximum dose other than in extreme circumstances, and this is demonstrated on our spreadsheet; this appeared to be an acceptable response.
We had some difficulty responding to their questions as to what we do when patients have positive urine screens for opioids or for illicit substances. While we routinely screen all our patients on a random basis, patients often have a tendency to drop out of treatment if they are told to come in more frequently. We have observed that these patients often relapse entirely thereafter, returning to us after many months in far worse shape. We therefore utilize other therapeutic techniques designed to improve overall efficacy of treatment. The agents shared that this was typical, and that other facilities had shared with them their concern for this issue as well.
The agents were formal but friendly; the entire process was relaxed and comfortable though the physician being audited was understandably nervous. There are so many stories online concerning these DEA audits that are scary and concerning; I felt it would be sensible to report on a good experience with the process.