Is “Suspicious Order” about to be defined?

The recently-released DOJ OIG Review of the Drug Enforcement Administration’s Regulatory and Enforcement Efforts to Control the Diversion of Opioids has met with extensive media coverage focused on the sexier aspects of the story. What did DEA do or not do to stem the opioids crisis? What internal battles may have led DEA to drop the ball in some aspects of the response? These are important questions, but they have been well-covered.

Instead, we are going to focus on a handful of the nine recommendations (listed below) made by the IG and DEA’s and ODAG’s responses.

1.  “Develop a national prescription opioid enforcement strategy that encompasses the work of all DEA field divisions tasked with combatting the diversion of controlled substances and establish performance metrics to measure the strategy’s progress.”

DEA Response: That’s really the role of the Office of National Drug Control Policy, but they will do it, at least as far as their role in the process.

2.  “Require criminal background investigations of all new registrant applicants.”

DEA Response: Agreed. They are about to issue guidance that this is mandatory, effective immediately. (The guidance memorandum was, in fact, scheduled to be issued on October 1.)

Thoughts: It is one thing to require a criminal background check, but what findings lead to what results? There does not appear to be any guidance on this, at least as yet. What findings in a criminal background check would require or permit DEA to deny registration? Felonies only? All felonies? Misdemeanors? Current unresolved charges? An arrest record not resulting in conviction? What about crimes not involving controlled substances? Does the criminal behavior have to have occurred within a certain amount of time prior to the application or is it a “forever” ban? We hope the above-referenced guidance memorandum addresses these obvious questions.

3.  “Implement electronic prescribing for all controlled substance prescriptions.”

DEA Response: Agreed. Publishing a rule on this is a priority.

Thoughts: In general, this is a very good idea. But how does this rule affect rural practitioners and/or pharmacies or those that lack adequate resources to implement EPCS? Will there be a waiver process or some sort of financial assistance for the mandatory implementation of these procedures?  This is going to be a big lift for DEA, as it has yet to provide a Final Rule on its original EPCS regulation, let alone new regulations contemplating mandatory use of EPCS.

4.  “Require that all suspicious orders reports be sent to DEA headquarters.”

DEA Response: Agreed. The centralized database for the collection of suspicious order reports is required by the SUPPORT Act to be up and running by October 23, 2019. And they are drafting regulations regarding suspicious orders.

Thoughts: In the IG’s analysis of the DEA response, there is a key line: “The OIG has confirmed that the proposed rule, which defines the term ‘suspicious order’ and provides clarity to the registrant community on its reporting obligations, directly addresses the corrected action recommended in our report.” Is DEA about to define ‘suspicious order’ at long last? To have goalposts that do not move on the suspicious order reporting field would be a welcome change.

5.  “Take steps to ensure that DEA diversion control personnel responsible for adjudicating registrant reapplications are fully informed of the applicants’ history resulting in a prior registration being revoked by DEA, surrendering a prior registration for cause, losing a state medical license, or other conduct which may threaten the public health and safety by improving information provided to such personnel about the standards to apply in making decisions on such applications.”

DEA Response: Agreed. They will check their current procedures and see if any improvements can be made.

6.  “Revise field division work plan requirements to allow the flexibility to target registrants for investigation.”

DEA Response: Much of this is already in place, but new guidance is scheduled to be issued on October 1.

7.  “Revive a drug abuse warning network to identify emerging drug abuse trends and new drug analogues and respond to these threats in a timely manner.”

DEA Response: Agreed. They use and have recently expanded the NFLIS program to track these trends.

The final two recommendations were directed to the Office of the Deputy Attorney General.

8.  “Make efforts to enlist state and local partners to provide DEA with consistent access to state-run Prescription Drug Monitoring Programs.”

ODAG Response: They will do so to the extent that they are permitted to by law.

9.  “Consider expanding the Opioid Fraud and Abuse Detection Unit pilot to additional U.S. Attorney’s Offices and increasing the number of federal prosecutors dedicated to prosecuting opioid-related cases.”

ODAG Response: They will evaluate both of these recommendations, but DOJ leadership is ultimately responsible for determining how limited resources will be allocated.