End of year activities in Washington, D.C. are full of important messages for opioid treatment programs (OTPs). Among the things to watch, as we head into 2021:
42 CFR Part 2: for methadone patients, confidentiality has been key, and OTPs have the challenge of balancing regulations, which have recently been relaxed, with liability should a patient be adversely affected by release of information. On top of revisions made this summer, on December 14 the Substance Abuse and Mental Health Services Administration (SAMHSA) made it easier for law enforcement to investigate all substance use disorder (SUD) treatment providers as “pill mills,” as explained in a recent interview with Elinore McCance-Katz, M.D., J.D., outgoing Assistant Secretary of the Department of Health and Human Services. For the final rule, see https://www.federalregister.gov/documents/2020/12/14/2020-25810/confidentiality-of-substance-use-disorder-patient-records. Importantly, Dr. McCance-Katz pointed out that a court order must be obtained before programs can be investigated, adding that anyone who is doing quality care doesn’t have anything to worry about. Still, methadone patients are worried, especially about changes that will come about with CARES Act changes in March 2021 (see https://atforum.com/2020/04/provisions-in-cares-act-affecting-otps/).
Questions about new administration: Who will president-elect Joe Biden choose as his nominee to run the Office of National Drug Control Policy? One favorite for the position is H. Westley Clark, M.D., J.D., a former official at SAMHSA who also headed OTPs and whose expertise on methadone and buprenorphine is unrivaled in bureaucracy. However, former Congressman Patrick Kennedy, who has favored other forms of Medication Assisted Treatment (MAT)including injectable buprenorphine, is also lobbying for the job. In his affiliation with Advocates for Opioid Recovery, Kennedy helped fight for Medicare coverage for methadone (see https://atforum.com/2018/08/opioid-bills-senate-focus-medicare-otps/), Kennedy was a strong supporter of MAT.
As head of SAMHSA, the favorite is Arthur C. Evans, Jr., Ph.D., CEO of the American Psychological Association. As McCance-Katz stressed in our interview with her in December, mental illness is a significant mandate for SAMHSA, and whoever takes over needs to keep a strong focus on what is “evidence-based.” She was a strong proponent of methadone and buprenorphine as well as naltrexone for OUDs.
Continued flexibility under COVID-19: Last spring, SAMHSA and the Drug Enforcement Administration (DEA) took fast action to increase flexibility for methadone take-homes and buprenorphine induction (see https://atforum.com/2020/03/otp-regulations-loosened-due-to-pandemic). The program showed great success several months later (see https://atforum.com/2020/07/extended-methadone-take-homes-during-covid-nothing-but-success/) and many in the field hope it will continue even after the emergency, because the “other” epidemic – opioid overdoses – shows no signs of decreasing, and is even increasing.
Proposed legislation: Currently, three days of methadone or buprenorphine can be dispensed on an emergency basis to OUD patients in crisis, until they can get permanent treatment, but the patient would have to return each of those three days to the provider for the methadone. Proposed legislation would require the DEA to change the rules and allow a practitioner to give the patient the full three days’ worth of methadone or buprenorphine if the patient is in withdrawal. The American Association for the Treatment of Opioid Dependence (AATOD) has protested this bill, the “Easy Medication Access and Treatment for Opioid Addiction Act, H.R. 2281) saying that three days’ worth of methadone would be dangerous. AATOD did say that the bill could be amended to allow three days’ worth of buprenorphine. “My colleagues and I understand the intent of this legislation, which is to increase access to medication when patients present to emergency rooms and other emergency facilities when they are diagnosed with opioid use disorder but do not have immediate access to opioid use disorder treatment,” Mark W. Parrino, AATOD president, wrote to Rep. Raul Ruiz (D-Calif.) in a Dec. 14 letter. But the rationale for the current rule is “clear,” added Mr. Parrino: “physicians without specialized training are generally not sufficiently educated about the complex disease of addiction and pharmacokinetics of opioids.” Giving an unstable patient 3 days’ worth of methadone “would result in more overdose deaths, which is clearly counter to the intent of the legislation,” Mr. Parrino said. Unless the legislation can differentiate between methadone and buprenorphine, patient safety would be harmed. Buprenorphine has a greater safety profile than methadone because it is a partial agonist, Parrino noted.