On April 13, 2023, the White House took the unprecedented step of declaring xylazine-laced fentanyl an official emerging drug threat to the nation. The declaration is to be followed by a focused, 90-day response to this drug combination.
While fentanyl is well known and ripe for diversion in health care settings, lesser-known xylazine, also called “tranq,” is a veterinary sedative used illicitly as a low-cost cutting agent to extend a user’s high. New stories accompanying the White House’s announcement laid out grim images of the ulcers and amputations caused by xylazine and reminders that xylazine is not an opioid. That means the opioid overdose reversal drug naloxone does not work on xylazine, and xylazine’s sedative effects make the already deadly fentanyl “even deadlier,”according to the U.S. Drug Enforcement Administration (DEA).
Amy Bradshaw, U.W. 2006, is a director of the State Bar of Wisconsin Health Law Section. She has over 25 years of experience in health policy and health law, focusing on provider compliance, operations, and transactions.
As we await more details of the proposed response to the tranq-fentanyl combination, here are some recent opportunities related to substance use disorder (SUD) treatment and harm reduction:
Elimination of the Federal Waiver Requirement for Buprenorphine Prescribing
Buprenorphine is a partial opioid agonist that helps reduce opioid misuse, decrease risk for injection-related infectious diseases, and decrease risk for fatal and nonfatal overdoses.
Buprenorphine is sometimes prescribed on its own, but may also be provided in combination with naloxone, which blocks the effects of opioids. The brand name of this combination is Suboxone and compared to buprenorphine alone, it is less prone to abuse.
Until December 2022, physicians and others who wanted to prescribe buprenorphine in any form for the treatment of opioid addiction were required by the Drug Enforcement Agency (DEA) to complete a special training and certification program, known as the "X-waiver" or “DATA 2000 waiver.” Now, all practitioners who have a current DEA registration that includes Schedule III authority may prescribe buprenorphine for opioid use disorder in their practice if permitted by applicable state law.1
Despite the elimination of the wavier, certain tighter restrictions are expected to apply to the telemedicine prescribing of buprenorphine after the federal public health emergency ends in May 2023, per 88 Fed Reg. 12890, and this summer the DEA will be launching a new education requirement for any prescriber of opioids.
In addition to the federal requirements, Wisconsin requires buprenorphine prescribers to complete any relevant education required by their professional licensing board and consult the state’s prescription drug monitoring program (PDMP) before prescribing a controlled substance like buprenorphine, per Wis. Admin. Code CSB 4.105.
If a Wisconsin prescriber provides medication for addiction to more than 30 patients or meets certain other criteria, they may trigger Wis. Admin. Code DHS 75.60, which is an outgrowth of a recent overhaul of DHS chapter 75, and sets forth standards for office-based opioid treatment (OBOT).2
Practitioners prescribing buprenorphine for the first time should be mindful of what triggers the heightened privacy protections of 42 CFR Part 2. Practitioners who prescribe buprenorphine only need to follow 42 CFR Part 2 if they meet the definition of a “federally assisted program” as defined in 42 CFR 2.11 and 42 CFR 2.12(b) – namely, if they:
receive any type of federal assistance in the provision of services; and
work in a standalone SUD treatment program that holds itself out as providing, and provides, SUD services; or
work in an identified SUD unit of a general medical facility that holds itself out as providing, and provides, SUD services; or
if their primary function consists of providing SUD services and is identified as such.
It is important for practitioners who venture into medication-assisted therapy for SUD to follow proper prescribing protocols – including preventing diversion and providing appropriate patient monitoring and education.
Increased Access to Naloxone and Fentanyl Test Strips
With the FDA’s approval in March 2023 of the first over-the-counter naloxone, the nasal spray is expected to become more widely available this summer.
But meanwhile, the Wisconsin Department of Health Services' Standing Order for Naloxone allows pharmacists to dispense naloxone without a prescription to anyone who may be at risk of experiencing an opioid overdose or who may witness an overdose (practically speaking, this includes almost anyone).
The cost of the naloxone may be covered by insurance, and if a person does not have insurance, the pharmacy may be able to bill a noninsurance program. Some organizations, including Wisconsin Voices for Recovery, have provided free naloxone vending in community settings, such as the University of Wisconsin-Madison.
Fentanyl test strips can be used to detect the presence of fentanyl in drugs, which can help prevent overdose deaths by allowing individuals to make informed decisions about their drug use. After the decriminalization of fentanyl test strips in March 2022, Wisconsin began program to provide free fentanyl test strips to individuals who use drugs, health care providers, and harm reduction organizations.
The Wisconsin Department of Health Services maintains a map of locations for obtaining fentanyl test strips and naloxone at low or no cost.
Additional information about for professionals about these resources is available on the Wisconsin Department of Health Services webpage on opioids.
This article was originally published on the State Bar of Wisconsin's Health Law Blog. Visit the State Bar sections or the Health Law Section web pages to learn more about the benefits of section membership.
1 For more information, see Removal of DATA Waiver (X-Waiver) Requirement, Substance abuse and Mental Health Services Administration (SAMHSA).
2 For more information see Revised DHS 75 Implementation, Wisconsin Department of Health Services.