The Washington Post reports that the Biden Administration is preparing to pull back recent Health and Human Services (HHS) guidance designed to expand access to prescribing buprenorphine for opioid use disorders (OUD).
On January 14, 2021, HHS published Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder. In a nutshell the guidelines eliminated certain X-waiver certification requirements, allowing any DEA-registered prescriber to issue buprenorphine prescriptions for medication-assisted treatment of OUDs. The HHS notice does not reference any coordination with the Drug Enforcement Administration (DEA) and DEA has yet to publicly comment on this change.
According to The Washington Post, the concern raised by Biden Administration officials is that HHS did not have legal authority to create this exemption. Specifically, the certification requirements allowing the prescribing of buprenorphine for OUDs are mandated by Congress and only Congress can change those requirements.
Putting aside the legal issues, I think this is a good decision by the Biden Administration.
I understand that there are still access issues with respect to the availability of treatment for OUDs. Expanding access is certainly good policy. My long-standing concern (discussed by some in The Washington Post article), however, is that prescribers need to be better educated when treating OUDs. Removing even the minimal certification requirements places the public health and safety at risk. X-waiver prescribers continue to overprescribe the single-entity buprenorphine products, when in the overwhelming majority of cases the buprenorphine/naloxone products should be prescribed. We need to remember that buprenorphine is still a Schedule III controlled substance with abuse potential. While it is not always the case, diversion of buprenorphine usually involves the single-entity product.
Moreover, my experience has been that the X-waiver prescribers fail to do more than prescribe buprenorphine. They typically do not provide counseling or others services that, used in conjunction with drug therapies, have a much better outcome for the patient.
I know that there are strong opinions on both sides of this issue. While we all agree that expanding treatment options should be a priority of policymakers, we need to be smart about it. Better educated prescribers and greater guidance from HHS and DEA on the appropriate prescribing and treatment regime for OUDs would be a welcomed good first step.