With much support from many – but not the American Association for the Treatment of Opioid Dependence (AATOD), because of the omission of opioid treatment program (OTP) physicians, a bill which would allow pharmacies to distribute methadone and add the number of take-home doses is on the verge of being introduced by Rep Donald Norcross (D-New Jersey).
The move, which some have described as “modernization,” the bill would remove some of the restrictions to access to methadone, allowing patients to pick up 28 days of doses at a drugstore.
The bill, the Opioid Treatment Access Act, would eliminate the requirement that patients access methadone through OTPs only. OTPs are accredited and licensed by the federal government.
According to the December 6 press release announcing the bill, there are many significant supporters. These include Zachary Talbott, president of the National Alliance for Medication Assisted Recovery (NAMA Recovery), an organization composed of current and former methadone and buprenorphine patients and patient advocates whose mission is representing the voices and collective interests of patients. Talbott is an individual who credits his long-term recovery to medication assisted treatment, and he is also the owner and operator of opioid treatment programs.
“NAMA Recovery’s majority-patient Board of Directors acknowledges the critical and important role opioid treatment programs must play during the induction and stabilization of methadone treatment for opioid use disorder, but it is time access to treatment reflects the realities of patients’ daily lives,” said Mr. Talbott in his carefully worded statement. “ The Opioid Treatment Access Act ensures access to comprehensive OTP services based on patient needs and pushes federal rulemaking beyond arbitrary time-in-treatment requirements to be more evidence-based,” he said. “This legislation has the potential to save and restore many lives when opioid overdose deaths continue to spike to historically unprecedented levels.”
In introducing the bill December 6, Norcross, a member of the Bipartisan Addiction and Mental Health Task Force, said: “People struggling with opioid addiction shouldn’t be stigmatized. They shouldn’t be forced to wait in lines every morning for treatment,” said Norcross, a member of the Bipartisan Addiction and Mental Health Task Force, in a statement about the “imminent” introduction of his bill December 6. “They deserve dignity,” said Norcross, who is also a member of the Education and Labor Committee’s Health, Education, Labor, and Pensions Subcommittee. “They should be able to get their medicine from their pharmacist, just like everyone else does. If you can get the drug at a pharmacy, you should be able to get medicine to treat the drug misuse disorder at a pharmacy.”
Other supporters include the American Society of Addiction Medicine and Shatterproof.
“Current federal restrictions on treatment medications for opioid use disorder, like methadone, often prohibit patients from accessing needed treatment. In order for our lifesaving, clinically proven medication treatments to work, patients need better access to them,” said Kaitlan Baston, MD, MSc, DFASAM, division head of addiction medicine of Cooper University Health Care, also in comments from Norcross’ office, in a statement released by Norcross’ office. “That is why I am encouraged by the Opioid Treatment Access Act, which would allow patients to access methadone at a local pharmacy, rather than having to travel long distances, stand in line, and wait for this medication that patients must take every day to thrive.”
“With fatal overdoses surpassing 100,000 in the last 12 months, it’s time to tear down the barriers to life-saving medication-assisted treatment once and for all. I applaud Congressman Norcross for introducing this bill that will absolutely save lives,” said former U.S. Rep. Patrick J. Kennedy, founder of The Kennedy Forum, also in a statement from Norcross.
Early in the COVID-19 pandemic, the Substance Abuse and Mental Health Services Administration (SAMHSA) relaxed restrictions for take-home doses to limit exposure to the virus. Preliminary studies have shown these protocols increased engagement in treatment with few incidents of misuse (https://pubmed.ncbi.nlm.nih.gov/34670453/).
SAMHSA recently extended those exemptions by another year, and indications are that they will become permanent. However, even with the SAMHSA exemption, patients must obtain methadone only through OTPs.
“I am heartened by the announcement from Representative Norcross that he is planning to introduce proposed legislation (Opioid Treatment Access Act) to address regulatory and other barriers that limit the effectiveness of opioid addiction treatment with methadone,” said Robert Lubran, formerly director of SAMHSA’s division of pharmacological therapies, and now a consultant. “The announcement notes that an actual bill will be introduced soon with bipartisan support. I look forward to the details of the proposed bill which I understand from the press release would allow qualified physicians to prescribe methadone to patients at a pharmacy, a practice which is currently not allowed, and would modernize the process of receiving methadone at an opioid treatment facility,” Mr. Lubran told AT Forum.
“The bill has broad support within key advocacy organizations in the mental health and addiction treatment field including ASAM and NAMARecovery,” noted Mr. Lubran. “Once the bill is released I would hope that other organizations that represent populations impacted by the opioid crisis will consider joining on and endorsing the bill.”
Asked for a comment, Mark Parrino, AATOD president, told AT Forum that “In general, our Association supports a number of elements in Congressman Norcross’s bill,” adding that this “support is seen through our recently released policy paper.”
AATOD has advised the Congressman’s staff that a number of the proposed reforms have either been implemented by the Drug Enforcement Administration and SAMHSA or are in the process of being implemented, said Mr. Parrino.
However, AATOD does not support “physician prescribing of methadone to treat opioid use disorder so that such prescriptions can be filled by pharmacies,” said Mr. Parrino. “This is consistent with our Association’s ongoing recommendations.”
And it’s helpful to remember that methadone overdoses – mainly associated with pain prescriptions and always by non-OTPs – almost put methadone treatment for OUD out of business. “We are reminded of the five national methadone mortality reports, which were published between 2003 and 2010,” recalled Mr. Parrino. “All of these reports concluded that methadone mortality was the direct result of physicians in private practice prescribing methadone to treat pain and distribute it through pharmacy channels.”
With the current shifting opioid use epidemic, driven primarily by illicit fentanyl use, AATOD has “learned that treating such patients is very challenging in order to achieve stability in treatment,” said Mr. Parrino. “This requires a nuanced appreciation of how to treat opioid use disorder, especially when dealing with the combined challenge of methamphetamine/stimulant use.”
And there are great concerns about treatment being viewed as “medication only without the appropriate clinical support,” said Mr. Parrino. “In our judgment, treating opioid use disorder goes well beyond the prescribing of medication,” he said.
And none of this should be a surprise, coming from AATOD, which has steadfastly held to the principle of comprehensive treatment. ““Once again, we have been consistent in promulgating such evidence-based policies from our inception,” said Mr. Parrino.
“The bill Congressman Norcross will introduce in the House, if enacted, hopefully will result in important and long overdue improvements to federal regulations which have not kept up to date with the opioid overdose crisis,” Mr. Lubran told AT Forum. “These regulations, first proposed in 1999 by the Alcohol Drug Abuse and Mental Health Administration (ADAMHA), were drafted in an era when prescription opioid misuse was beginning to be recognized as a serious problem in many areas of the country and long before fentanyl became a household name,” he said. “ADAMHA subsequently was transformed into the Substance Abuse and Mental Health Services Administration (SAMHSA) in 1992.”
But Mr. Lubran, like others (not AATOD), is “disappointed that SAMHSA and the Department of Health and Human Services (DHHS) have not shown the leadership demonstrated by Congressman Norcross, along with the organizations cited as supporting the bill, in reducing regulatory barriers which have been reported out by National Academy of Medicine reports, research studies authored by experts like Dennis McCarty and by patients who have left treatment too soon because of outdated and ineffective rules.”
Once the bill has been released – and on December 20 it had not yet been introduced – we will publish further comments.
Companion legislation is being led in the Senate by Senator Ed Markey (D-MA).
Details of the bill
The Opioid Treatment Access Act would
- Allow certain prescribers to prescribe up to 1-month take-home doses to be dispensed at a pharmacy so that patients can receive methadone for OUD at more accessible locations and allowing states to permit aspects of that care to be conducted via telehealth
- Shorten the timeline for take-home methadone
- Direct SAMHSA to conduct a full study on the impact of the COVID-19 methadone exemptions
- Codify regulations that allow OTPs to operate mobile medication components without separate registration
- Emphasize that states should align their regulation of OTPs in a way that is consistent with the intent of this legislation and breaks-down barriers to care