No abuse of discretion pill mill trial procedure, sentencing vacated and remanded

The trial court did not abuse its discretion when it admitted expert testimony deemed admissible under Daubert, a federal appellate court has ruled. The testifying physician relied upon several sources that are generally accepted by the medical community when he reviewed the prescribing physician’s patient files, and he applied his methodology reliably. The court also did not err when it gave the pattern jury instructions on deliberate ignorance without tailoring the instruction to the facts of the case, nor when it refused to give the physician’s proposed jury instructions. However, the trial court did err when it applied the firearms increase in the course of sentencing the physician (U.S. v. Roland, June 14, 2018, per curiam).

Pill mill operations

In August 2014, an Atlanta-area physician was charged in a 22-count indictment with conspiracy to dispense controlled substances and related violations. All of the alleged activities arose from his and his co-conspirators’ participation in a “pill mill” scheme involving several pain management clinics in the greater Atlanta area. A jury convicted the physician on one count of conspiracy to distribute controlled substances and seven counts of unlawful distribution of controlled substances, in violation of 21 U.S.C. §841. The district court sentenced him to 130 months of imprisonment. On appeal, he challenged his convictions and his sentence.

Expert testimony

The government’s expert witness described the standards set forth in the Federation of State Medical Boards’ model policy for the use of controlled substances to treat pain (FSMB), and he also relied upon several other sources that are generally accepted by the medical community when he reviewed the physician’s patient files. The expert witness summarized each of the guidelines in order to analyze the physician’s prescribing practices, and he then individually compared 96 patients’ files to this analysis, pointing out instances where the physician failed to adhere to the guidelines’ standards. The appellate court found that by commenting on and making conclusions about the physician’s care for each patient based on the review criteria, the expert witness applied his methodology reliably and did so without relying exclusively on his own experience as a prescribing physician. Accordingly, they found that his expert testimony met the required standards, and that the expert testimony was properly admitted.

“Deliberate ignorance” jury instruction

The government had requested that the pattern jury instruction on deliberate ignorance be modified by adding a sentence that “in this example, you would treat the defendant as having knowledge that the package contained a controlled substance.” The physician requested that the district court omit the deliberate ignorance instruction entirely, arguing that the instruction did not make sense based on the theories presented at trial: his theory was that he was deceived by a co-conspirator and did not know that he was working at pill mills, while the government’s theory was that the physician possessed actual knowledge that the clinics were pill mills. Therefore, neither party had raised an argument as to deliberate ignorance. The district court denied both parties’ requests and gave the pattern deliberate ignorance instruction. The appellate court ruled that the trial court did not err in giving the deliberate ignorance jury instruction based on the fact that the evidence presented at trial warranted it because the physician had advised a co-conspirator to lie to the Georgia Composite Medical Board, and because he had explained to his patients that he needed to write the prescriptions in a certain way in order to avoid criminal liability.

Firearms increase at sentencing

The district court cited two reasons for the firearm increase: (1) the co-conspirator’s security guard possessed a firearm while monitoring the parking lots at the clinics; and (2) several firearms were found in the physician’s bedroom at his own clinic. However, the appellate court found that the district court erred in applying §2D1.1(b)(1) of the U.S. Sentencing Guidelines Manual, a firearm increase, for two reasons. First, the evidence showed that the co-conspirator alone hired the security guard, and the government presented no evidence that the physician ever interacted with the guard or knew he had a firearm; and second, because the physician was a licensed firearm instructor and his possession of so many firearms was simply a reflection of his hobby.

For the foregoing reasons, the physician’s convictions were upheld, but his sentence was vacated and the matter remanded for resentencing.

New law stops potential criminalization of EMS ‘standing orders’ for timely controlled-substance use

A new bipartisan law, the Protecting Patient Access to Emergency Medications Act of 2017, P.L. 115-83, signed by President Trump on November 17, 2017, amends the Controlled Substances Act (CSA) (P.L. 91-513) to clarify that emergency medical services (EMS) professionals (including nurses, paramedics, and emergency medical technicians) are able to continue administering controlled substances (contained in schedules II, II, IV, or V) to critical patients, such as pain narcotics and anti-seizure medications, pursuant to standing (written medical protocol) or verbal (oral directive) orders when authorized by state law (Protecting Patient Access to Emergency Medications Act of 2017, P.L. 115-83, enacted November 17, 2017).

It has been a long-standing practice for medical directors of EMS agencies to write standing orders for the administration of controlled substances by EMS professionals. As reported by Emergency Physicians Monthly, in a January 2015 meeting with the National Association of EMS Physicians (NAEMSP) Executive Committee to discuss possible EMS regulations, the Drug Enforcement Administration (DEA) stated its position that the CSA only allows for patient-specific orders for controlled substances and that it is illegal for EMS agencies to deliver any controlled substances under written medical protocols or standing orders. Therefore, absent this new legislation, it was the position of the DEA that any regulations concerning EMS agencies would be required to prohibit the continued use of standing orders for EMS professionals.

The law also allows EMS agencies the option of having a single DEA registration in each state where the EMS agency administers controlled substances, in lieu of requiring a separate registration for each location of the EMS agency within the state, as long as certain transportation, storage, re-stocking, and recordkeeping rules for controlled substances are followed by the EMS agency. The act further provides that a hospital-based EMS agency may use the DEA registration of the hospital to administer controlled substances without an additional registration of its EMS agency.

The law was introduced as H.R. 304 in the House of Representatives by Reps. Richard Hudson (R-NC) and G.K. Butterfield (D-NC). The Senate version, S. 916, was introduced by Sens. Bill Cassidy (R-La) and Michael Bennet (D-Colo). H.R. 304 initially passed the House by a vote of 404-0 on January 9, 2017. It passed the Senate, as amended, by unanimous consent, on October 24, 2017.

Four VA facilities weak on controlled substance diversion protections

In recent years, diversion of controlled substances has occurred at several Veterans Affairs (VA) medical facilities. In fact, in a 2009 and 2014 report, the VA Office of the Inspector General (OIG) identified a number of weaknesses in VA medical facilities’ implementation of controlled substance inspection programs. For example, the VA OIG found that some VA medical facilities had not conducted the required monthly inspections, and when facilities did conduct the monthly inspections, the inspections were sometimes incomplete because they did not follow all of the required Veterans Health Administration (VHA) procedures.

GAO review

As a result of these deficiencies, Congress requested that the Government Accountability Office (GAO) report on VHA’s processes to reduce the risk of diversion of controlled substances at its medical facilities and VHA’s oversight of these processes. The report examined: (1) the extent to which selected VA medical facilities have implemented controlled substance inspection programs as required by VHA policies, and (2) VHA’s oversight of these programs at selected VA medical facilities.

Implementation of inspections

The GAO found weaknesses in the way four VA medical facilities were implementing their controlled substance inspection programs. Two of the four facilities did not conduct monthly inspections of controlled substances as required by the VHA. Between January 2015 and February 2016, one facility missed 43 percent of monthly inspections in critical patient care areas and the pharmacy. Further, inspections that three of the four facilities performed did not include or follow three or more of the nine VHA requirements. At two of the three facilities, inspectors did not properly verify that controlled substances had been transferred from VA pharmacies to patient care areas; nor did inspectors ensure that all controlled substances on hold for destruction were properly documented.

Contributing factors

GAO discovered that several factors contributed to the failure to adhere to VHA policy. First, the two facilities that missed inspections lacked an additional control procedure (such as the use of an alternate controlled substance coordinator) to help prevent missed inspections when inspectors could not conduct them due to professional or other personal responsibilities. Second, three of the four facilities did not ensure their written procedures included the nine VHA program requirements. Third, while the VHA relies on coordinators at the facilities to ensure that the inspections are completed appropriately, the GAO found that VHA’s training course for the coordinators does not focus on its required inspection procedures.

Inconsistent oversight

The GAO also found inconsistent oversight at the selected facilities of their controlled substance inspection programs by facility directors and the Veterans Integrated Service Networks to which the facilities report. Directors at two of the four selected VA medical facilities had not implemented corrective actions to address missed inspections identified in the monthly inspection reports. In addition, two of the four selected networks did not review their facilities’ quarterly trend reports, as required by VHA. One network that had reviewed the trend reports failed to follow up with a facility to ensure it had submitted missed trend reports. The GAO concluded that without effective oversight of the inspection programs by directors and networks, VHA lacks reasonable assurance that its programs are being implemented as required to prevent and identify diversion of controlled substances.

Recommendations

The GAO recommended that the Secretary of the VA direct the Under Secretary for Health to:

  • ensure that VA medical facilities have established an additional control procedure, such as an alternate controlled substance coordinator or additional inspectors, to help coordinators meet their responsibilities and prevent missed inspections;
  • ensure that VA medical facilities have established a process where coordinators, in conjunction with pharmacy officials, periodically compare facility inspection procedures to VHA’s policy requirements and modify facility inspection procedures as appropriate;
  • improve the training of VA medical facility controlled substance coordinators by ensuring the training includes the inspection procedures that VHA requires;
  • ensure that medical facility directors have designed and implemented a process to address nonadherence with program requirements, including documenting the nonadherence and the corrective actions taken to remediate nonadherence or the actions that demonstrate why no remediation is necessary; and
  • ensure that networks review their facilities’ quarterly trend reports and ensure facilities take corrective actions when nonadherence is identified.

The VA concurred with the GAO’s recommendations.

Highlight on Arkansas: medical marijuana amendment approved

On November 8, 2016, Arkansas voters approved Issue 6, the Arkansas Medical Marijuana Amendment which amended the state’s constitution, by a margin of 53 percent in favor to 47 percent against, and became the first state in the South to legalize medical marijuana. The governor had voiced his opposition to the measure. With the approval, more than half of the states in the U.S. have now legalized medical marijuana.

A “yes” vote supported legalizing medical marijuana for 17 qualifying conditions, creating a Medical Marijuana Commission, and allocating tax revenue to technical institutes, vocational schools, workforce training, and the state’s general fund. A “no” vote opposed the amendment to legalize medical marijuana. The amendment will allow patients with a variety of medical conditions, including cancer, Tourette’s syndrome, Crohn’s disease, fibromyalgia, post-traumatic stress disorder, and HIV/AIDS, along with a doctor’s permission to buy marijuana from dispensaries. Patients, however, won’t be allowed to grow their own marijuana.

The Arkansas Department of Health was given up to 120 days to adopt rules for various provisions of the amendment, including, but not limited to:

  1. applications for and renewals of registry identification cards;
  2. labeling and testing standards for marijuana distributed to patients;
  3. care givers assisting patients who are physically disabled or under the age of 18;
  4. requirements for oversight, recordkeeping, security requirements for dispensaries and cultivation facilities;
  5. the manufacture, processing, packaging, and dispensing of marijuana to patients;
  6. procedures for suspending or terminating the licenses of dispensaries and cultivation facilities that violate the provisions of the amendment;
  7. procedures for inspections and investigations of dispensaries and cultivation facilities; and
  8. advertising restrictions for dispensaries and cultivation facilities;

A separate marijuana question had been approved, but Arkansas’ Supreme Court last month directed that votes not be counted. Justices said the petition lacked enough valid signatures. In 2012, Arkansas voted on the Arkansas Medical Marijuana Question, which failed to garner enough support. Following the approval of Issue 6, opponents vowed to fight the amendment in the Arkansas legislature.