HHS Expands Access to Buprenorphine for Opioid Use Disorder

January 20, 2021 - HHS recently announced that it will expand access to medication-assisted treatment (MAT) for opioid use disorder.

Under the agency’s guidelines, Practice Guidelines for the Administration for Buprenorphine for Treating Opioid Use Disorder, which will soon be published, physicians will be exempt from specific certification requirements needed to prescribe buprenorphine.

The exemption only applies to physicians who only treat patients who are located in the states in which they are authorized to practice medicine, and only applies to the prescription of drugs or formulations covered in the X-waiver of the CSA.

Notably, the exemption does not apply to the prescription, dispensation, or use of methadone for the treatment of opioid use disorder.

"The medical evidence is clear: access to medication-assisted treatment, including buprenorphine, that can be prescribed in office-based settings, is the gold standard for treating individuals suffering from opioid use disorder," Adm. Brett P. Giroir, MD, assistant secretary for health, said in the announcement.

"Removing some of the certification requirements for an  X-waiver for physicians is a step toward providing more people struggling with this chronic disease access to medication assisted treatment,” Giroir continued.

The guideline also issues exemption from certain certification requirements under 21 U.S.C of the Controlled Substances Act (CSA) for physicians licensed under state law and who possess DEA registration, HHS stated.

Any physician utilizing this exemption will only be able to treat up to 30 patients with buprenorphine for opioid use disorder at any time, and a working group will monitor the implementation and results of these guidelines, HHS said.

According to the CDC, over 83,000 drug overdose deaths occurred in the US over 12 months, from June 2019 to June 2020. This is the highest number of overdose deaths ever recorded in a 12-month period.

Specifically, this number of overdoses is an increase of over 21 percent compared to the previous year.

Without MAT, the chances of relapse for an individual who suffers from opioid use disorder are more likely. HHS stated that previous studies have shown that outcomes for people with opioid use disorder are significantly better with MAT.

The increase in overdose deaths highlights the need for treatment services to be more accessible for those most at risk of overdose.

Back in 2018, CDC estimated that the total “economic burden” of prescription opioid misuse alone in the US is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice.

Although the opioid crisis continues to be a challenge in the US, access to opioid care is not as accessible as it should be. 

In mid-May 2020, a study from Columbia University Mailman School of Public Health found that long-term buprenorphine treatment was linked to notably lower rates of prescription opioid use and opioid-related events, including medically treated overdoses.

Compared to 4,433 adults who discontinued buprenorphine six to nine months after beginning treatment, individuals saw a notable lower risk of all-cause inpatient (52 percent) and emergency department services (26 percent).

Additionally, researchers observed reductions in opioid-related hospital services (128 percent), overdose events (173 percent), and opioid prescriptions (120 percent) in the follow-up period than in the treatment period.

At the beginning of August, FDA announced that it is requiring label changes for opioid pain medicines and medicine used to treat opioid use disorder.

Under the label changes, healthcare professionals should consider prescribing naloxone when they prescribe medicines to treat opioid use disorder, or to patients being prescribed opioid pain medicines that are increased risk of opioid overdose.

FDA required that these recommendations be added to the prescribing information for opioid pain medicines and medicines to treat OUD, such as buprenorphine, methadone, and naltrexone.