Federal lawmakers introduced a new bill that would loosen regulations on methadone prescribing.
Legislators released the Modernizing Opioid Treatment Access Act in the U.S. House of Representatives and the Senate. A bipartisan group announced the bill, saying it would be vital in expanding care for opioid use disorder (OUD).
“This legislation lowers barriers to care at a time when we are still suffering staggering losses due to the ongoing opioid epidemic,” Rep. Donald Norcross (D-N.J.) said in a news release. “We must end the monopoly on this life-saving medicine that only serves to enrich a cartel of for-profit clinics and stigmatize patients.”
Norcross is a sponsor of a version of the bill introduced in the House of Representatives. The other original sponsors of the bill in the House are Reps. Don Bacon (R-Neb.) Brain Fitzpatrick (R-Pa.), Annie Kuster (D-N.H.), David Trone (D-Md.), Paul Tonko (D-N.Y.), Brittany Pettersen (D-Colo.) and Andy Kim (D-N.J.)
In short, the bill calls for vital changes to how health care providers may prescribe and pharmacies may dispense methadone.
Modernizing Opioid Treatment Access Act would allow 30-day supplies of unsupervised methadone doses from providers that are already registered to prescribe controlled substances and have board certification in addiction psychiatry or addiction medicine.
Most methadone doses must be opioid treatment program (OTP) offices while a provider watches. OTP-based providers may prescribe take-home, unsupervised doses after a patient has demonstrated stability.
The bill would also allow pharmacies to dispense methadone for OUD. Pharmacies may already dispense methadone for pain management.
It also states that dispensing medications via pharmacies “shall be in addition to the other care that the individual continues to have access to through an opioid treatment program.”
The bill would also allow for telehealth-delivered support such as counseling and other ancillary services. Should the bill become law, the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) would jointly track these prescriptions.
“As a physician, I know the value of the doctor-patient relationship,” Sen. Rand Paul (R-Ky.) said in a news release. “This bipartisan legislation will return treatment decisions to health care providers, who know their patients best.”
Sen. Edward Markey (D-Mass.) is the primary sponsor of the bill in the Senate.
The following senators join Markey and Paul as co-sponsors: Bernie Sanders (I-Vt.), Mike Braun (R-Ind.), Cory Booker, (D-N.Y.) and Margaret Wood Hassan (D-N.H.).
The OTP advocacy group American Association for the Treatment of Opioid Dependence (AATOD) has already spoken out against loosening methadone prescribing.
A similar group of legislators introduced a similar bill — called the Opioid Treatment Access Act — in early 2022; the bill didn’t get past an introduction in the House of Representatives.
Jason Kletter, president of the national addiction treatment provider BayMark Health Services, wrote an op-ed pushing back against allowing more methadone prescribing outside of OTPs. He is also involved with AATOD at the national and state levels.
“Opioid treatment programs understand the high stakes of the opioid epidemic better than anyone. And while many people opine about how to solve the opioid epidemic, policymakers and advocates need to pay attention to recommendations of the people who work day in and day out caring for people with opioid use disorder,” Kletter said. “The focus should be on optimizing the health care system, not watering down what’s known to work while simultaneously putting individuals and communities at risk.”
Kletter has also previously expressed skepticism in interviews with Behavioral Health Business about loosening the prescribing regulations regarding buprenorphine.
Methadone is a key medication in treating OUD. It’s one of only three that is cleared for such care by the Food and Drug Administration. It is also a Schedule II controlled substance, meaning that it is “considered dangerous” and has “high potential for abuse,” according to the DEA.
This risk partly led to the rise of OTPs, sometimes called methadone clinics.
On top of federal regulation, OTPs are subject to a patchwork of state regulations. Many states require organizations seeking to open an OTP to get special approval to do so or to get the same licensure as pharmacies, according to Pew Charitable Trust research.
Advocates for the bill point to relative and uneven access to OTPs. Rural areas especially suffer from a lack of access.
SAMHSA has already loosened some methadone prescribing practices for OTPs following the end of COVID-era flexibilities.