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What’s happening with all the NPRMs and bills?

March 28, 2023 by Alison Knopf

Quick summary from AT Forum

Confused by all the bills and proposals? That puts you in good company with most of America, except for us nerds who do nothing else. Here’s a quick summary of what’s going on in the methadone (and sometimes, buprenorphine) world, and who’s for what.

Regulatory

Telemedicine and buprenorphine: The Drug Enforcement Administration is going to extend telemedicine flexibilities that originated with the pandemic for buprenorphine, allowing new patients to get prescriptions via telemedicine. However, the DEA wants these prescribers to examine the patient within a few weeks. The treatment community is against the examination requirement, saying it will decrease access. https://atforum.com/2023/03/dea-telemedicine-flexibilities-buprenorphine-controlled-substances/

Part 8: A massive methadone reform proposal from the Substance Abuse and Mental Health Services Administration (SAMHSA) would make many of the flexibilities from the pandemic era permanent, and add some new flexibilities (https://atforum.com/2022/12/samhsa-proposal-update-methadone-regulations/). The proposal, which refers to 42 CFR Part 8, would keep opioid treatment programs (OTPs) in charge of prescribing, however. Here’s who’s for and who’s against.

  • The American Society of Addiction Medicine (ASAM) (https://onlinelibrary.wiley.com/doi/full/10.1002/adaw.33727) and the National Alliance for Medication-Assisted Recovery (NAMA) (https://onlinelibrary.wiley.com/doi/10.1002/adaw.33701) would like office-based practitioners to be able to prescribe methadone, providing they are certified in addiction medicine, and not, as the NPRM requires, to have this privilege restricted to opioid treatment programs.
  • The American Association for the Treatment of Opioid Dependence (AATOD) (https://onlinelibrary.wiley.com/doi/10.1002/adaw.33707) approves of the proposal to allow midlevel practitioners to prescribe on the same level as medical doctors.
  • The American Academy of Addiction Psychiatry (AAAP) was silent in its comments on whether office-based practitioners should prescribe methadone, but objected to the proposal to expand prescribing privileges to mid-levels.

Part 2: There is also a proposal from the Department of Health and Human Services (HHS) to further weaken 42 CFR Part 2, which is about confidentiality of substance use disorder treatment records (https://onlinelibrary.wiley.com/doi/10.1002/adaw.33631). The Legal Action Center (https://onlinelibrary.wiley.com/doi/10.1002/adaw.33661), H. Westley Clark, M.D., former director of SAMHSA’s Center for Substance Abuse Treatment (https://onlinelibrary.wiley.com/doi/10.1002/adaw.33688), a prominent addiction psychiatrist (https://onlinelibrary.wiley.com/doi/10.1002/adaw.33694), Stop Stigma Now (https://onlinelibrary.wiley.com/doi/10.1002/adaw.33714), and PRO-A (https://onlinelibrary.wiley.com/doi/10.1002/adaw.33684) called for retracting the proposal, saying patients will be harmed. ASAM, however, called for getting rid of the special confidentiality protections and fully aligning Part 2 with HIPAA (https://onlinelibrary.wiley.com/doi/10.1002/adaw.33722).

Legislative

Meanwhile, Congress, just as the comment period for the Part 8 methadone NPRM was ending, has come up with a revived version of its OTAA from last year (https://atforum.com/?s=OTAA). The Modernizing Opioid Treatment Access Act would make prescriptions of methadone for opioid use disorder available from any addiction clinician, not just from OTPs. It is supported by ASAM and NAMA. Lawmakers sponsoring used language denigrating OTPs in official press statements, criticizing them for being for profit, and calling them a cartel (https://atforum.com/?s=cartel).

Filed Under: 2023, Newsletter

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