HHS Rescinds Opioid Treatment Guidelines, Now What?

Just days after the U.S. Department of Health and Human Services (HHS) announced the creation of new guidelines designed to increase access to medication-assisted treatment (i.e. buprenorphine) for opioid use disorder, the Biden administration rescinded them.

The guidelines, which were issued in the final days of the Trump administration, made it easier for physicians with a Drug Enforcement Administration (DEA) register number to prescribe medication-assisted treatment for opioid use disorder by exempting them from certain certification requirements needed to prescribe the drug.

The Substance Abuse and Mental Health Services Administration (SAMHSA) posted the following announcement on its website:

“On January 14, 2021, HHS announced forthcoming Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder. Unfortunately, the announcement was made prematurely. Therefore, the Guidelines previously announced cannot be issued at this time. However, HHS and ONDCP are committed to working with interagency partners to examine ways to increase access to buprenorphine, reduce overdose rates and save lives.â€

According to statistics from the Centers for Disease Control and Prevention, more than 81,000 people died of drug overdoses in the U.S. in the 12 months ending in May 2020. That’s the highest number of overdose deaths ever recorded in a 12-month period.

Synthetic opioids (primarily illicitly manufactured fentanyl) appear to be the primary driver of the increases in overdose deaths, increasing 38.4 percent from the 12-month period leading up to June 2019 compared with the 12-month period leading up to May 2020, according to the CDC, which attributed the COVID-19 pandemic as a primary driver of the increase.

A new study, published in JAMA Psychiatry earlier this month found significantly higher rates of visits to emergency departments between March and October 2020 for opioid overdoses. The study, which analyzed nearly 190 million visits found that the rate was up by 45 percent compared to the same period a year earlier.

Since the Biden administration’s announcement, a bipartisan group of lawmakers sent a letter calling on the president to allow for the expansion of medication-assisted treatment. In it they note:

“Under current law, medical professionals must receive a waiver from the Drug Enforcement Administration (DEA) in order to prescribe buprenorphine to treat substance use disorder. This burdensome requirement does not improve patient safety, but does lead to treatment bottlenecks and a lack of providers across the country, particularly in rural areas.â€

The previously announced guidelines addressed the following:

• Physicians with a Drug Enforcement Administration (DEA) registration number are no longer required to apply for a separate waiver to prescribe buprenorphine for OUD treatment.

• Eligible physicians are limited to treating 30 patients or fewer with buprenorphine for OUD treatment at any one time. This does not apply to hospital-based physicians who may initiate treatment but who do not engage in a long-term treatment relationship with the patient.

• Physicians who use this exemption may only treat patients in the state where they are authorized to practice medicine.

• The exemption applies only to the prescription of drugs or formulations covered under the X-waiver of the CSA, such as buprenorphine, and does not apply to the prescription, dispensation, or use of methadone for the treatment of OUD.

• Physicians who use this exemption shall place an “X” on the prescription and clearly identify that the prescription is being written for opioid use disorders (along with the separate maintaining of charts for patients being treated for OUD).

• An interagency working group will be created to monitor the implementation and results of these practice guidelines, as well as the impact on diversion. The working group will meet at least twice a year and make formal recommendations as to whether the guidelines should be continued, discontinued or modified.

As this matter is a moving target, the Health Law Offices of Anthony C. Vitale will continue to keep an eye on developments. Our firm represents clients in matters relating to DEA licensure as well as investigations and audits. For more information contact us at 305-358-4500 or email info@vitalehealthlaw.com.