Three bills going through Congress would change the way buprenorphine treatment is delivered, mainly eliminating the x-waiver, the training required for the special Drug Enforcement Administration (DEA) license allowing the dispensing of the medication for opioid use disorders (OUDs).
The Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act, introduced in February by Senators Rob Portman (R-Ohio) and Sheldon Whitehouse (D-R.I.), would expand upon the pandemic emergency regulatory waivers so that patients can get prescriptions and therapy via telehealth. The flexibilities include allowing prescribing of buprenorphine without a physical exam, and being able to bill Medicare for telephone-only prescriptions.
“The COVID-19 pandemic has affected every aspect of our lives and the increase in overdoses we’re seeing only increases the need for additional flexibility to help those suffering from addiction. I’ve had the opportunity to hear about the successes of telehealth in treating substance use disorder directly from behavioral health providers who have continued their fight against the addiction epidemic amidst the ongoing COVID-19 pandemic,” said Senator Portman when the bill was released. “The rollout of telehealth waivers has both helped patients maintain access to care safely at home and increased access to care for those who didn’t otherwise have access to in-person treatment. As we move forward and look to life beyond this pandemic, we must make sure that the advances to care and access that telehealth is currently providing are not lost, and that’s exactly what this bill will do. I urge my colleagues to join me in supporting this common-sense legislation to make telehealth a permanent part of substance abuse disorder treatment.”
“Overdoses have taken a heartbreaking toll on families from every walk of life during the pandemic,” said Senator Whitehouse.
The TREATS Act is supported by ASAM, the National Safety Council, Community Catalyst, Boston Medical Center, the National Association of Addiction Treatment Providers, Shatterproof and The Kennedy Forum.
MAT Act vs. MATE Act
The Mainstreaming Addiction Treatment (MAT) Act would eliminate the x-waiver, facilitating treatment by primary care.
The Medication Access and Training Expansion (MATE) Act would require prescribers of buprenorphine to be trained first. Proponents would like to see the MATE Act adopted first, and only then could the MAT Act – with the elimination of the x-waiver – take place.
The American Association for the Treatment of Opioid Dependence (AATOD) supports the MATE Act, and last year issued a “fact check” comparing the two bills.
- MAT Act “Fact”: “For two decades, buprenorphine has been used as a safe, effective and life‐saving medication‐assisted treatment for individuals suffering from a substance use disorder.”
- AATOD “Fact Check”: It’s true that buprenorphine, in combination with psychosocial services, has been effectively used for two decades. However, the vast majority of individuals currently receive no counseling. This has led to lower treatment retention and poor clinical outcomes. Simply prescribing medication alone is not medication‐assisted treatment.
- MAT Act “Fact”: “Medical professionals need a special DEA waiver to prescribe buprenorphine to treat substance use disorder, which leads to treatment bottlenecks and a lack of providers.”
- AATOD “Fact Check”: No such bottleneck exists. The Substance Abuse and Mental Health Services Administration approves applicants within 45 days. There are currently more than 72,000 waivered prescribers approved to treat 4.3 million patients. This is more than double the number of estimated individuals living with an opioid use disorder in our country. However, only about half of the waivered medical practitioners are actually prescribing.
- MAT Act “Fact”: “This outdated waiver requirement has stuck around even though medical professionals can prescribe the same drug for pain without jumping through bureaucratic hoops.”
- AATOD “Fact Check”: Federal and state authorities have been working urgently to implement prescribing limits and increase prescriber education to mitigate the practices that led to the current opioid epidemic. This legislation moves in the opposite direction by removing education requirements and limits, making it easier to prescribe a medication known to be highly diverted and misused.
- MAT Act “Fact”: “Removing this barrier will massively expand treatment access, making it easier for medical professionals to integrate substance use disorder treatment into primary care settings.”
- AATOD “Fact Check”: Eliminating the waiver and training requirements will massively expand access to medication, not treatment. This proposed legislation does not provide medical professionals with the resources needed to integrate quality substance use disorder treatment into their settings. Only 8% of American medical schools offer education on addiction. Yet this legislation will reduce education for medical professionals wishing to treat this disorder.
- MAT Act “Fact”: “After nearly 20 years of safe treatment, there is no good reason to maintain a separate, more burdensome regulatory regime restricting access to safe, proven addiction treatments including buprenorphine.”
- AATOD “Fact Check”: There is no data on the efficacy or quality of medication-assisted treatment provided in primary care settings. There is, however, data available on the rates of misuse and risks of overdose associated with buprenorphine. The RADARS (Researched Abuse, Diversion and Addiction-Related Surveillance) system found that during 2018, individuals presenting for opioid treatment in the United States reported misuse of buprenorphine in 27.4% of cases, and within these, 15.3% indicated misuse of buprenorphine by injection.
- MAT Act “Fact”: “The additional waiver requirement reflects a longstanding stigma around substance use treatment and sends a message to the medical community that they lack the knowledge or ability to effectively treat a patient with substance use disorder.”
- AATOD “Fact Check”: The stigma surrounding medication-assisted treatment for opioid use disorder is generated in large part when diversion and misuse of these medications occur. Diversion control plans are not required of medication-assisted treatment provided in a primary care setting. The rate of buprenorphine diversion has been steadily increasing as more buprenorphine is prescribed. The number of opioid treatment admissions reporting buprenorphine as a primary drug of misuse has also steadily increased.
- MAT Act “Fact”: “Practitioners are already required to obtain a license to prescribe controlled substances and meet any state‐level requirements to prescribe buprenorphine.”
- AATOD “Fact Check”: The requirement to obtain a license has already proven insufficient to ensure safe prescribing practices. A prior lack of adequate training and best practice guidelines for pain management and opioid prescribing led to inadvertently bad prescribing outcomes and deaths. Practitioners are not trained to use opioid treatment medications. The waiver requirement helps protect consumers from untrained practitioners inappropriately prescribing powerful opioids.
- MAT Act “Fact”: “After France took similar action to make buprenorphine available without a specialized waiver, opioid overdose deaths declined by 79% over a four‐year period.”
- AATOD “Fact Check”: This proposed legislation fails to address key differences between France and the model that would be created in the United States as a result of this bill. In France, practitioners can only prescribe for seven days at a time and must specifically justify a longer duration. No such limits exist in the United States, where Schedule III drugs like buprenorphine can be refilled up to five times without requiring a new prescription. Pharmacies in France supervise administration for the induction period and for some time beyond. U.S. pharmacies are not equipped to oversee daily administration of medication to patients. Also, widespread co‐prescribing of benzodiazepines in France suggests a need for more practitioner training — exactly what this legislation would remove.