An Oklahoma doctor wrote 19 Schedule II controlled substance prescriptions for a patient with low back pain over eight months without thoroughly documenting the patient’s history, confronting the patient over aberrant drug tests, or talking to other doctors who were prescribing the patient controlled substances. The Chief Administrative Law Judge felt the doctor should be granted a new registration, but placed on probation for one year. Acting Administrator Chuck Rosenberg disagreed. He reviewed the case and concluded that DEA proved that the doctor knew the patient was abusing or diverting the drugs and prescribed anyway. Dr. Wesley Pope’s application for a new DEA registration was denied as inconsistent with the public interest.
Summary of the Issues
In the Final Order, published on March 23, 2017, Acting Administrator Chuck Rosenberg on several occasions disagreed with, questioned, or rejected the rationale of Chief Administrative Law Judge John J. Mulrooney, II. The three main issues were: (i) whether the Oklahoma Medical Board’s record-keeping requirements for the treatment of chronic pain were permissive or mandatory; (ii) whether the prescriptions were issued for a legitimate medical purpose in the practitioner’s usual course of professional practice under federal law; and (iii) whether Public Interest Factor #2 (the practitioner’s experience in dispensing controlled substances) should take into account a practitioner’s track record of lawful dispensing or if, instead, DEA can focus on the practitioner’s alleged bad acts.
Summary of the Facts
Dr. Pope, of Newcastle, Oklahoma, wrote 19 prescriptions between August 2011 and May 2012 for a 27-year-old male patient whose primary complaint was low back pain. At the same time, the patient was being treated by a psychiatrist for depression and anxiety and was being prescribed Xanax (generic name: alprazolam). The patient was required to take multiple drug screens, several of which came back with arguably aberrant results, including one test that detected no alprazolam, even though the patient was being prescribed alprazolam every month, and one test that showed no morphine in the patient’s system, even though morphine had been prescribed within the previous 30 days. Dr. Pope came to the authorities’ attention on May 10, 2012, when the patient was found semiconscious and intoxicated in a vehicle parked on the center median of a highway in Norman, Oklahoma. The patient had several prescription bottles of opiate pain killers in the car that had been prescribed by Dr. Pope, and, according to police, a search of his cell phone indicated he was illegally buying and selling prescription drugs. The police also found sexually explicit text messages between Dr. Pope’s cell phone and the patient. At the time, Dr. Pope’s medical license was on probation for a past incident involving prescribing controlled substances to someone with whom he was having a sexual relationship.
The Administrator rejected the Chief ALJ’s dismissal of much of the Government’s expert’s testimony, stating that the Chief ALJ got Oklahoma’s pain management regulations wrong.
The government’s expert in pain management stated that, under Oklahoma law, a doctor prescribing controlled substances for pain must adequately document in the patient’s chart that he or she evaluated the patient’s chief complaint, other treatments the patient had undergone, the patient’s ability to function in daily life in light of the pain, and whether the prescribing of controlled substances provided a therapeutic benefit. The expert concluded that Dr. Pope failed to do that and, thus, failed to issue prescriptions that were valid under state law.
The Chief ALJ declined to give weight to much of the expert’s testimony. He said that the record-keeping requirements were permissive, rather than mandatory. It is “not the documentation of the medical determination that carries the day here,” according to the Chief ALJ. “Rather, it is whether the evidence supports the [doctor’s] proposition that he made such a determination . . . .” 82 Fed. Reg. 14944, 14980 (March 23, 2017).
Acting Administrator Rosenberg sided with the expert. He concluded that Oklahoma law requires a doctor engaged in treating patients with controlled substances for chronic pain to document: the nature and intensity of the pain; current and past treatment for pain; any underlying or coexisting diseases or conditions; the effect of the pain on physical and psychological function; and any history of substance abuse. Dr. Pope did only a superficial evaluation of the patient’s purported pain complaint, his medical history, and the effect of the pain, and he performed only a cursory exam that did not support the medical diagnosis, according to the Administrator. As a result, Dr. Pope never established medical necessity and none of the prescriptions were validly issued to the patient, the Administrator said.
The Administrator and the Chief ALJ also departed significantly on their interpretation of whether and when an Oklahoma doctor who is treating a patient with controlled substances for chronic pain should refer the patient to a mental health expert or consult with other providers when the patient also suffers from depression, anxiety, or both. The Chief ALJ interpreted the Government’s expert’s testimony as stating that the Oklahoma Pain Management regulations include a “mandatory mental health referral requirement.” The Chief ALJ rejected that as inaccurate. The Administrator, in contrast, concluded that the expert was saying that Oklahoma law requires a doctor to use sound clinical judgment in determining whether a referral or consultation is necessary. Dr. Pope never referred the patient to an addiction specialist, never consulted with the patient’s mental health provider, and never documented his reasoning. According to the Administrator, “there is ample evidence . . . that [Dr. Pope] breached the standard of care when he failed to even consult with [the patient’s] mental health providers.” Id. at 14972.
The Administrator held that all of the controlled substance prescriptions issued to the patient violated 21 C.F.R. § 1306.04(a) because none of them were issued for a legitimate medical purpose by a doctor acting in the usual course of his professional practice.
Just as the Administrator found that the prescriptions were invalid under state law, he found that they were invalid under federal law because no medical necessity was ever established and because, when the doctor continued prescribing without resolving aberrant drug screenings, without getting details when the patient stated that his prescription drugs were stolen, and without assessing whether controlled substances were helping the patient achieve his stated goal of returning to work, the doctor was acting outside of the usual course of professional practice.
Dr. Pope issued some of the Schedule II prescriptions without seeing the patient. The Administrator noted that 21 C.F.R. § 1306.12(b) permits a practitioner to issue multiple prescriptions for a Schedule II drug to provide up to a 90-day supply based on seeing the patient only every 90 days, but a practitioner who does so must have established: (a) medical necessity, (b) legitimate therapeutic benefit, and (c) that the patient does not have a high-risk of abuse. The Administrator concluded that Dr. Pope had not done any of those things.
The Chief ALJ argued that DEA, over the years, has obliterated any difference between Public Interest Factor #2 and Public Interest Factor #4.
A DEA registration application can be denied if the registration would be inconsistent with the public interest. 21 U.S.C. § 823(f). There are five factors to consider in making the public interest determination. The Chief ALJ stated that DEA “has been engaged in a deliberate winnowing of the scope of Factor 2, [the applicant’s experience in dispensing controlled substances], to the extent that . . . it now largely mirrors the considerations found in Factor 4,” [compliance with state, federal, and local controlled substance laws]. Id. at 14981. He argued that a practitioner’s track record of lawfully prescribing controlled substances might be a significant consideration under Factor 2. Id. The Acting Administrator pushed back against that argument. He said: Nowhere “is there any support for the notion that Congress deemed the quantitative volume of a practitioner’s dispensings to be a significant consideration in making findings under the experience factor.” Id. at 14982. DEA has given “no more than nominal weight to a practitioner’s evidence that he has dispensed controlled substances to thousands of patients in circumstances that did not involve diversion,” according to the Administrator, because no amount of legitimate dispensings can change the fact that flagrant violations of the law are inconsistent with the public interest. Id. (internal citations omitted).
Once the Administrator determined that the prescriptions violated federal law, he focused on what the Chief ALJ called Dr. Pope’s “almost dogged determination to accept no responsibility for his actions.” Id. at 14985. This was problematic for Dr. Pope because “where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for [his] actions and demonstrate that [he] will not engage in future misconduct.” Id. at 14985 (citing Medicine Shoppe—Jonesborough, 73 Fed. Reg. 364, 387 (2008). Administrator Rosenberg denied Dr. Pope’s application, effective March 16, 2017.