Buprenorphine Legislation: From the X Waiver to the MAT Act 

The Drug Addiction Treatment Act of 2000 waiver, also known as the DEA X-waiver, allowed clinicians to prescribe buprenorphine, a controlled substance medication, to treat opioid dependency. Established in 2000, the law required physicians to undergo specific training and register with Drug Enforcement Administration (DEA) before prescribing buprenorphine to their patients for substance use disorder (SUD) treatment. 

The X-waiver was intended to help increase patient access to buprenorphine and to improve regulation of buprenorphine to prevent misuse. In the years since, some experts were critical of the X-waiver process, arguing that it was too restrictive and has created unnecessary barriers for patients seeking treatment for opioid use disorder (OUD) amidst the ongoing opioid epidemic.  

To address these issues, the Biden Administration signed the Mainstreaming Addiction Treatment Act (MAT Act) into law at the end of last year, aimed to expand access to medication for OUD for individuals struggling with substance misuse, addressing the ongoing opioid crisis in the country. It eliminated the federal X-waiver requirement for clinicians. Now, if a clinician can prescribe narcotics, they may also prescribe buprenorphine without additional waiver requirements.  

Using Buprenorphine to Treat OUD 

Buprenorphine therapy is a vital treatment for OUD. Clinical research has shown that medication for OUD reduces the likelihood of overdoses, facilitates healthier pregnancies, and decreases incidents of hepatitis C in young people. The passage of the MAT Act also brings to light the crucial need for regulation by DEA to ensure the safe and effective implementation of medication for OUD programs.  

DEA has already passed some regulations on buprenorphine prescriptions following the passage of the MAT Act, and more are anticipated. For example, the following requirement is effective as of June 27, 2023: “The Consolidated Appropriations Act of 2023 enacted a new one-time, eight-hour training requirement for all DEA-registered practitioners, except veterinarians, on the treatment and management of patients with opioid or other substance use disorders.”  

Restricted Supply of Buprenorphine Hinders Patient Access 

Unfortunately, access to buprenorphine is a major issue due to the suspicious drug order monitoring requirement. Drug wholesalers use monitoring systems that are triggered by large orders of opioids. The use of these monitoring systems may result in pharmacies being cut off from the supply because of concerns about DEA enforcement. This issue has been brought to the attention of DEA, with requests for clear regulatory guidance regarding the supply of buprenorphine.  

Before the X-waiver was eliminated, only 57.9% of pharmacies reported that buprenorphine was in stock at the time of the patient’s request, with chains being more likely to have stock than independent pharmacies. This number varies greatly by state, with 37.1% in Florida vs 83.9% in Washington. With an increase in demand likely from the X-waiver elimination, supply will have to match this demand. For the drug to be available to patients, monitoring systems cannot be triggered by orders of the drug, which means DEA will need to modify its regulations. 

Reducing the SUD Stigma Through Education 

Many state regulators are now prioritizing the promotion of effective opioid treatments aimed at decreasing overdose fatalities and enhancing the overall well-being of patients. States are also focused on reducing the stigma associated with SUD. The goal is to involve pharmacies in providing access to care and thereby reduce opioid overdose deaths and improve harm reduction.  

A recent study has shown that continuing education beyond what was required by DEA to receive the X-waiver was associated with greater prescribing of buprenorphine among clinicians. Although there is no one-size-fits-all solution, continuing health professionals’ education on the matter seems to promote patient treatment and well-being.  

Expanding Patient Access to Buprenorphine 

By eliminating the X-waiver requirement and expanding access to buprenorphine in the pharmacy, hope remains that the strain on emergency departments and hospitals, which often bear the brunt of opioid-related emergencies such as overdoses and infections, will be reduced. With the disparities between urban and rural areas in the number of clinicians with an X-waiver, eliminating this barrier to access will promote greater health equity.  

To achieve these goals, the stigma surrounding medication to treat OUD can be challenged by building deeper education and awareness about the issue. We support helping patients on their journey toward recovery and lasting wellness through promoting pharmacist-provided medications for treatment. 

This blog was adapted from an article that originally appeared in the September 2023 issue of Innovations.