DEA Issues Proposed Rule to Expand Access to Mobile Opioid Treatment

On February 26, 2020, DEA issued a proposed rule titled Registration Requirements for Narcotic Treatment Programs with Mobile Components. The proposed rule would waive the requirement of a separate registration for opioid treatment programs (OTPs) that utilize a mobile component.

The Controlled Substances Act (CSA) generally requires, with certain exceptions, all persons who dispense controlled substances to obtain a separate registration at each “principle place of business or professional practice” where they dispense a controlled substance. The CSA also, however, authorizes the Administrator of the Drug Enforcement Administration (DEA), by delegation of the Attorney General, to issue regulations that would waive the registration requirement in certain instances if he finds it consistent with the public health and safety.

If finalized, the proposed rule would waive the requirement of a separate registration for OTPs that provide medication for opioid use disorder out of mobile vehicles. It would allow registrants to dispense controlled medications from schedules II-V for the purpose of maintenance or detoxification services at a location remote from, but within the same state as, the OTP’s registered location. A registrant that intends to operate a mobile OTP must notify the local DEA office in writing and obtain explicit written approval from the local DEA office prior to operating the mobile OTP.

DEA stated that the proposed rule is consistent with the public health and safety because it will expand access to OUD treatment in rural and other underserved areas with minimal risk of diversion.

DCBA Partner Discusses Drug Pricing Bills in Congress on Fox Business

DCBA Law & Policy Partner Michael Barnes recently made an appearance on Fox Business Live, where he discussed conflicting messages about the impact of the U.S. drug abuse crisis on corporate profits. Barnes then analyzed drug pricing bills in Congress and how they could affect Americans’ access to new medicines for conditions like Alzheimer’s and cancer. The original program aired on December 12, 2019.

DCBA Partner Moderates at Pain Management Summit

DCBA Law & Policy partner Stacey L. Worthy moderated a panel discussion today at the sixth annual Summit on Balanced Pain Management. Worthy led a dialogue between Ann Quinlan Colwell, PhD, RN, of the American Society for Pain Management Nursing (ASPMN); Ellen Blackwell, MSW, of the Centers for Medicare and Medicaid Services (CMS); and Matt Salo of the National Association of State Medicaid Directors. The panel addressed several topics, including how CMS is approaching ‘patient-centered care’ and Medicaid’s coverage of integrative pain management.

Read the Institute for Pain Access’s recap of the entire Summit here: https://instituteforpatientaccess.org/patient-centered-care-dominates-pain-policy-summit/

U.S. Surgeon General: Warm Handoffs Are ‘Immediate Priority’

On Thursday, October 24, the Senate Finance Committee held a full committee hearing on the topic of substance abuse in the United States. Among the witnesses was the Surgeon General of the United States, Jerome M. Adams, MD, MPH. Dr. Adams detailed the current approach of the Department of Health and Human Services (HHS), highlighted reasons for optimism, and identified areas where continued efforts are necessary.

Dr. Adams stated that “HHS’s immediate priorities include…emergency department medication-assisted treatment (MAT) programs with warm handoffs following overdose…”.

Two of DCBA’s attorneys, Michael C. Barnes and Daniel C. McClughen, authored one of the first-ever law review articles on the topic of warm-handoffs. The article was published in the Fall 2018 issue of the University of Memphis Law Review. Barnes and McClughen have continued their work on warm handoffs through the Warm Handoff Initiative, an initiative of the Center for U.S. Policy.

Read the entire testimony of the Surgeon General and other witnesses.

Read the Barnes & McClughen article on warm-handoffs.

Learn more about the Warm Handoff Initiative.

Aggressive DOJ Actions Against Opioid Prescribers Continue

An article published yesterday by Pain News Network’s Pat Anson tells the story of yet another physician who has faced threats from the Department of Justice (DOJ) due to the use of opioids within his practice. Dr. Roger Kasendorf, a physician from Southern California, paid a settlement of $125,000 rather than defend against allegations of illegal opioid prescribing.

Dr. Kasendorf claims the allegations were an effort to extort him and were based solely on inadequate recordkeeping, rather than any actual evidence of illegal prescribing habits. He agreed to settle on the advice of his attorney, who said that paying the settlement would more economically sensible than fighting the allegations.

DCBA Managing Partner Michael C. Barnes is quoted in the article, weighing in on the potential legitimacy of Dr. Kasendorf’s extortion claim. “Without reviewing the medical records, I cannot assess the fairness of this outcome. If the physician were merely a big-data outlier because he took on patients with the most complex needs, and if his prescribing were CSA (Controlled Substances Act)-compliant, then the behavior of the federal government would fall squarely under the Black’s Law Dictionary definition of extortion.”

Barnes also stressed how important it is for practitioners to maintain thorough, accurate, and up-to-date records. “The DOJ treats controlled-medication prescribers, especially big-data outliers, as though they are guilty until proven innocent. Detailed medical records are the only affordable way for a provider to prove his innocence – or at least make the prosecutor think twice about proceeding with criminal charges.”

Read the full article here.