The American Association for the Treatment of Opioid Dependence (AATOD) and Opioid Treatment Programs (OTPs) have been at the forefront of trying to reform methadone treatment, always with an eye on patient safety and quality treatment, also while making treatment more accessible. But, as AATOD president Mark Parrino puts it, it’s important to ask “Access to what?” If it’s medication only, there is little evidence that will work.
So while AATOD in general supports changes in regulations, what runs throughout AATOD’s opposition to sections of two bills currently in Congress is the assumption by lawmakers that all people with OUD need is medication.
Below are the two bills, with AATOD commentary on what proponents, and the bills themselves, say.
S. 2639 – Office-based prescribing of methadone
Take the Opioid Treatment Access Act (OTAA), S.3629. AATOD opposes section 4 of this bill, calling it “dangerous” because it allows private practice physicians to prescribe methadone for opioid use disorder with no controls or oversight.
Below is a chart showing what the supporters of the OTAA claim about Section 4, and what the facts are according to AATOD.
|The bill will increase access to treatment.
|It will result in physicians prescribing a powerful medication with no effort to limit diversion, no counseling, no drug testing and no outcome reporting to evaluate effectiveness – exactly how we got into the current opioid epidemic and record numbers of deaths.
|Board Certified Physicians are adequately trained to provide effective treatment.
|Board certified physicians are well trained, which is necessary; however, training alone is not sufficient to provide safe treatment. Treatment is comprised of much more than just prescribing more opioids.
|Increased take-homes granted by OTPs during the pandemic prove that patients can take methadone safely.
|The OTP structure is what makes methadone safe and effective for OUD. Suggesting that methadone is safe and effective for OUD in any other setting is not based on evidence.
|More prescribing without any controls will decrease overdoses and deaths.
|At least five federal reports issued in the 2000s found that the majority of methadone mortality is attributable to physicians prescribing methadone in private practices.
|Providers have been prescribing buprenorphine for OUD for 20 years.
|Buprenorphine and methadone are very different medications, hence different FDA scheduling (buprenorphine is Schedule III, methadone is Schedule II). Buprenorphine is unlikely to cause respiratory depression; methadone can. Methadone is slow to act and accumulates in the body, making it especially lethal if misused. Despite exponential increases in buprenorphine prescriptions over the past 20 years, ODs and deaths have notched up record levels every year. More opioid prescriptions do not stop ODs. Buprenorphine is one of the most widely diverted medications in the U.S. because it is widely distributed by physicians with no diversion-control effort. Methadone diversion rates have declined significantly over the last 20 years.
|Other countries give out methadone at pharmacies.
|The study by John Strang et al. (Impact of supervision of methadone consumption on deaths related to methadone overdose, BMJ 2010) found that the “introduction of supervised methadone dosing was followed by substantial declines in deaths related to overdose of methadone in both Scotland and England.” Supervised dosing refers to the dispensing and monitoring process required at OTPs, where patients consume treatment medication on-site in the presence of medical personnel. Pharmacy-filled prescriptions do not require this consumption-monitoring process. Furthermore, the study by Graham Gauthier et al. (Improved treatment retention for patients receiving methadone dosing within the clinic providing physician and other health services onsite versus dosing at community offsite pharmacies, Drug and Alcohol Dependence, 2018) in Canada found that when methadone is prescribed for OUD and picked up at a pharmacy, patients had a 11.9% one-year retention rate compared to a 57.3% one-year retention rate when getting the medication from a methadone clinic.
The MAT Act (S. 445 and H.R. 1384) – getting rid of the X-waiver for buprenorphine
Noting that “the facts on the ground have changed” since the Mainstreaming Addiction Treatment (MAT) Act was first introduced. AATOD noted that although for five years the country has been relaxing rules for prescribing buprenorphine for OUD, overdose deaths keep going up. In 2018, Congress in the SUPPORT Act required information about the efficacy of buprenorphine treatment by prescribers, but the Department of Health and Human Services failed to act on this.
Here is a chart showing what the MAT Act says, with a fact check by AATOD.
|MAT Act Fact Sheet
|“For two decades, buprenorphine has been used as a safe, effective and life-saving medication-assisted treatment (MAT) for individuals suffering from a substance use disorder.”
|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.
|“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.”
|No such bottleneck exists. SAMHSA approves applicants within 45 days. There currently are more than 121,000 waivered prescribers approved to treat more than 7.5 million patients. This is more than triple the number of estimated individuals living with an OUD in our country. However, only about half of the waivered medical practitioners are actually prescribing, indicating that there are other barriers beyond the x-waiver.
|“This outdated waiver requirement has stuck around even though medical professionals can prescribe the same drug for pain without jumping through bureaucratic hoops.”
|In response to the opioid crisis, federal and state authorities worked urgently to implement prescribing limits and increase prescriber education to mitigate the misguided prescribing practices that contributed to the epidemic. This legislation moves in the opposite direction by removing the education requirement and limits that currently protest consumers and making it easier to prescribe a medication known to be diverted and misused.
|“Removing this barrier will massively expand treatment access, making it easier for medical professionals to integrate substance use disorder treatment into primary care settings.”
|Eliminating the waiver 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. Many individuals with an OUD engage in polysubstance misuse, much of which requires psychosocial interventions, not medication alone. Of adults with a substance use disorder, 37.9% also have a co-occurring mental health disorder.
|“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.”
|There are no data on the efficacy or quality of MAT provided in primary care settings. There is, however, data available on the rates of buprenorphine misuse. The RADARS (Researched Abuse Diversion Addiction Related) surveillance system found that during 2018, individuals presenting for opioid treatment in the U.S. reported misuse of buprenorphine in 27.4% of cases, and within these, 15.3% indicated misuse of buprenorphine by injection.
|“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.”
|The stigma surrounding MAT for opioid use disorder is generated in large part when diversion and misuse of these medications occur. Diversion control plans are not required of MAT 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.
|“Practitioners are already required to obtain a license to prescribe controlled substances and meet any state-level requirements to prescribe buprenorphine.”
|The requirement to obtain a license has already proven insufficient to ensure safe prescribing practices. A lack of adequate prescriber training on best practice guidelines for pain management and opioid prescribing has been identified as a significant factor in the development of the opioid epidemic. The waiver requirement addresses these past wrongs and helps protect consumers from untrained practitioners inappropriately prescribing powerful opioid medications.
|“After France took similar action to make buprenorphine available without a specialized waiver, opioid overdose deaths declined by 79 percent over a four-year period.”
|This legislation fails to address key differences between France and the model that would be created in the U.S. In France, pharmacies can only dispense seven days’ worth of buprenorphine. Physicians must specifically justify a longer duration. No such limits exist in the U.S. where Schedule III drugs like buprenorphine can be refilled up to 5 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. Also, widespread co-prescribing of benzodiazepines in France suggests a need for more practitioner training – exactly what this bill would remove.
Four ways forward
There are four proposals which could provide increased access to quality treatment, according to AATOD:
- Make permanent the provisions of the SUPPORT Act that require Medicare and Medicaid coverage of OTP services
- Allow OTPs to admit patients to treatment using telehealth
- Codify COVID take-home regulatory flexibility
- Fund pilot programs for OTPs to develop innovative partnerships with hospitals and Federally Qualified Health Clinics in rural areas.
There was one other bill, the MATE Act, which does not have a companion bill in the Senate.