House Opioid Measure Frenzy Continues

Over a period of two weeks in June, the House passed several bills aimed at combating the ongoing opioid epidemic. Our summary of the earlier measures can be found here. Key points of these additional legislative initiatives are summarized below. We will continue to monitor and report on their progress.

R. 3192, CHIP Mental Health Parity Act
This bill required state Children’s Health Insurance Program (CHIP programs) to cover mental health benefits including substance use disorder services for pregnant women and children. It also prohibits states from imposing financial or utilization limits on mental health treatment that are lower than the limits placed on physical health treatment.

R. 3331
Specifically, this bill encourages the Center for Medicare and Medicaid Innovation to test models to provide incentive payments to behavioral health providers for adopting electronic health records technology, and using that technology to improve the quality and coordination of care.

Continue Reading

House Passes 12 Bills Aimed at Combating Opioid Crisis

On Tuesday, the House of Representatives passed a fleet of bills aimed at combating the ongoing opioid crisis, most aimed at developing preventative measures to curb opioid addiction by funding research. The measures passed with overwhelming bipartisan support. Key points of these legislative initiatives are summarized below. Quarles & Brady will continue to monitor their progress.

Continue Reading

Federal Judge Overturns DEA’s Immediate Suspension Order…for now.

A United States District Court Judge issued a temporary restraining order prohibiting the Drug Enforcement Administration (DEA) from enforcing the Immediate Suspension Order issued against Morris & Dickson.

Acknowledging, that the entire administrative record was not before the court, Judge Foote nonetheless held that “Plaintiff has demonstrated a substantial likelihood that it will be able to prove that the Acting Administrator’s finding is arbitrary and capricious” and that “Morris & Dickson faces a substantial threat of irreparable harm if the immediate suspension of DEA Certificates of Registration Nos. RM0314790 and RM0335732 is not enjoined and that the balance of equities and the public interest favor granting a temporary restraining order.”

A preliminary injunction hearing is currently scheduled for May 22.

Alleged Failure to Report Suspicious Orders Leads to Suspension

On May 2, 2018, the DEA issued an Order to Show Cause and Immediate Suspension of Registration (the “Order”) against Morris & Dickson Co., LLC (“M&D”), a drug distributor based in Louisiana with pharmacy customers in 7 states. The DEA has two main allegations against M&D:

  1. M&D failed to maintain effective controls against division of controlled substances into other than legitimate channels, in violation of 21 USC 823(b)(1) and 21 CFR 1301.71.
  2. M&D failed to identify and report suspicious orders to DEA, in violation of 21 CFR 1301.74(b).

Continue Reading

DEA Proposes Changes to Quota Regulations

On April 19, 2018, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rule Making (NPRM) proposing various changes to DEA’s process for setting Aggregate Production Quotas (APQ) and Individual Procurement Quotas (IPQ). Here are some of the more significant “changes” proposed in the NPRM:

Aggregate Production Quotas

  • DEA must consider the diversion of a particular class of drugs when setting APQ;
  • DEA must also consider information from HHS, FDA, CDC, CMA, and state information when setting APQ;
  • DEA must consider diversion as one of the factors for adjusting APQ;
  • Allows for a hearing, if requested, and necessary to resolve issues related to a state’s objection to changes in APQ.

Continue Reading

States Looking to Tax Opioid Distributions

As the national discussion on opioid abuse continues, state governments are looking to their tax laws as a way of “addressing” the issue. The Kentucky House recently approved a 25 cent per pill tax for every dose sent into the state. The measure now moves to the Kentucky Senate. The state expects to raise $70 million a year from the tax. Kentucky does not, however, intend to use the funds for opioid addiction treatment, but plans to use the tax revenue for unrelated budget needs. Continue Reading

DEA Gives Wholesalers Access to Some ARCOS Data, but Not Quantities Purchased

The DEA issued a short press release yesterday that, at first glance, appeared to deliver on something that wholesale drug distributors have been seeking for years—access to ARCOS data so that wholesalers can see the total number of controlled substances a customer is ordering.* Despite the sensational headline, the new DEA tool is underwhelming and misses the mark because it will only tell a wholesaler how many other wholesalers a prospective customer has purchased a controlled substance from in the past six months. Unfortunately, this tool will provide little to no usefulness to distributors in identifying suspicious orders. Continue Reading

Enforcement Initiatives Just One of the Topics at the Summit on Controlled Substances

 

 

 

 

 

I am pleased to be part of the roundtable panel, “Update on State and Federal Enforcement Initiatives,” at the American Conference Institute’s Summit on Controlled Substances, being held January 29-31 at the Washington Plaza Hotel in Washington, D.C.

Conference faculty will discuss current challenges, benchmark strategies, and how to prepare for the future of this critical and fast-paced industry. Hear from:

  • Current and former DEA attorneys
  • Current and former FDA attorneys
  • State and U.S. attorneys
  • In-House Counsel
  • Top law firm counsel

Topics include:

  • Reassessing Your Responsibilities in Light of the Changing Scope of Suspicious Order Monitoring Requirements
  • Evolution of Abuse-Deterrent Opioid Drug Products
  • Understanding and Comparing State Prescription Drug Monitoring Programs
  • Diving Into State, County, and City Opioid-Related Investigations

Register today and use the code P10-999-DEA18 to receive a discount on registration fees.

Are DEA Administrative Hearings Fundamentally Unfair to Registrants?

While a great deal of attention is given to DEA Chief Administrative Law Judge Mulrooney’s (“CALJ Mulrooney’s”) opinion regarding the impact of the Ensuring Patient Access and Effective Drug Enforcement Act on DEA enforcement efforts, very little attention has been afforded a shocking and unprecedented attack by a sitting DEA Administrative Law Judge on DEA’s formal administrative hearing process found within the same article.

Hidden in plain sight at the end of CALJ Mulrooney’s and Ms. Katherine Legel’s soon-to-be-published law review article is a thirty page attack on the procedures that govern DEA administrative hearings, substantive decisions in final agency decisions, and the individuals assigned to draft final agency decisions on behalf of the agency. Continue Reading

Be Careful What You Wish For:  DEA to Update Suspicious Order Reporting Regulations

In a recently issued Request for Proposal (RFP) for Information Technology (IT) and other services in support of the Diversion Control Division, DEA indicated that it will be creating a new section in the Code of Federal Regulations. 21 C.F.R. 1301.78, will contain the suspicious order reporting requirement that is currently found in 21 C.F.R. 1301.74(b). DEA intends to define the term “suspicious order” with a list of specific factors to consider when scrutinizing an order. DEA is expected to require that the “presence of any one or more of these factors renders the order a suspicious order,” which must be reported to DEA via a secure network application for Suspicious Order Reporting System (SORS). Continue Reading

LexBlog