September 23, 2019

Bills in the House & Senate to “Deregulate” Buprenorphine and Other Legislative & Regulatory News

As discussed in a recent “ACEP 911, Legislative Network Weekly Update” newsletter, there are now bills in the US House (HR 2482) and the US Senate (SR 2074) which seek to “deregulate” buprenorphine prescribing. Specifically, these relatively brief resolutions (~ 4 pages each), both known as the “Mainstreaming Addiction Treatment Act” or MAT Act, (with the obvious allusion to term “MAT” as we know it), will dismantle ADA 2000 (and thus CARA as well), and allow clinicians to prescribe buprenorphine for opioid use disorder without limitations, without the need for a DEA X-waiver, and with no patient limits. This is clearly long overdue.

Both bills are bipartisan. In May, Rep. Paul Tonko (D-NY) introduced HR 2482 together with two other Democrat and three Republican co-sponsors. Before the August recess, this bill had recorded 78 co-sponsors (~ 63 Democrat and ~ 15 Republican). Seems like a win for both parties -- increasing access to care (a traditional Dem priority) and deregulating healthcare (a traditional GOP priority). The Senate bill was introduced in July by Sens. Murkowski (R-AK) and Hassan (D-NH), and by the August recess had added a 3rd co-sponsor. The Senate bill also includes a provision to further loosen restrictions on providing treatment for opioid use disorder (OUD) by telemedicine. The ACEP Board received input from several members of this section and subsequently decided to support for this legislation.

Pew Charitable Trusts, a non-partisan think tank and public policy advocacy group, has been instrumental as a lobby group in advancing HR 2482. Together with Rep. Tonko’s office, they organized and moderated in July a congressional briefing with a panel of experts, on which I, with ACEP’s support, had the pleasure of serving. The other experts on the panel were Sarah Wakeman, MD (Harvard/Mass General), Daniel Ciccarone, MD (UCSF), and Rebecca Haffajee, JD, PhD (Univ. of Michigan). This same group was then able to have a very frank closed-door meeting with Admiral Brett Giroir, the US Assistant Secretary of Health, seeking to gain the support of the Department of Health and Human Services (HHS) for this legislation. 

The bills are gaining momentum, and the following organizations have published position statements or letters to Congress declaring support:

  • American Medical Association (AMA), 2019-7-25 Letter to Tonko re: HR 2482 MAT Act from James Madera, MD, CEO of AMA.
  • American Society of Addiction Medicine (ASAM) – with some conditions
  • National Council for Behavioral Health (NCBH) 
  • National Association of Attorneys General (NAAG) - Learn More Here.
  • A coalition of Secretaries of State (petition representing at least 22 US states and territories), 2019-4-8 Petition letter to Alex Azar, Secretary, U.S. Department of Health and Human Services.

However, these bills are opposed by the American Academy of Addiction Psychiatry (AAAP), and Dr. Elinor McCance-Katz, the Assistant Secretary for Mental Health and Substance Use, who leads the Substance Abuse and Mental Health Services Administration (SAMHSA). 

No congressional hearings are scheduled yet, and HR 2482 has been assigned to three House committees.  Movement on SR 2074 is just getting started. No further progress is likely to occur until after Congress and the White House reach a budget deal this fall. There is a long way still to go. Thus, we need our members to contact their US House Reps and Senators, with passionate requests to co-sponsor these bills!

Also, in our July meeting with Admiral Giroir, he reported that his office is still trying to loosen the restrictions on the “Three Day Rule”(Title 21, Code of Federal Regulations, Part 1306.07(b)), so that emergency medicine doctors could prescribe or dispense a three-day supply of buprenorphine without a prescription. However, he could not yet declare any meaningful progress in that effort. The ACEP DC office has continued to pursue such a change to the “Three Day Rule” through regulatory channels, but it is still not clear if such changes can be made without congressional action. 

Additional recent developments

As per a recent section notice, SAMHSA has published proposed changes to 42 CFR Part 2. Please share your thoughts about these changes. The comment period will end at the end of October, and based on your feedback, ACEP will submit a letter of support and/or disagreement with the different changes. I would encourage all to review the document and share your thoughts with the section.

It seems that, among the several proposed rule changes, the following may be the most beneficial to our members: 

  • “non-OTP (opioid treatment program) providers will become eligible to query a central registry, in order to determine whether their patients are already receiving opioid treatment through a member program.  Per the proposed rule change, OTPs will be permitted to enroll in a state prescription drug monitoring program (PDMP) and permitted to report data into the PDMP when prescribing or dispensing medications on Schedules II to V, consistent with applicable state law.”
  • As HHS states in the “42 CFR Part 2 Proposed Rule Fact Sheet,” “The revised central registry and PDMP provisions will help to prevent duplicative enrollments in SUD care, duplicative prescriptions for SUD treatment, and adverse drug events related to SUD treatment.” It is not exactly clear how such a rule change would be applied , but I would submit that, even if this could simply inform the querying physician that a patient is currently receiving treatment in an OTP (usually a methadone clinic), without revealing any other information from the patient’s OTP medical or counseling record, this would be great progress. 

Recently, the Deputy Assistant Secretary for Planning and Evaluation (ASPE) of HHS sent out a request for information (RFI).

With the assistance of Scott Weiner, Alexis LaPietra, and Jeffrey Davis of the ACEP DC office, we were able to craft a response which strongly advocates for:

  • Support for removing the X-waiver (and thus, support for HR 2482, SR 2074);
  • Relaxing the Three-Day Rule, as described above;
  • Removing barriers such as pre-authorization requirements for prescribing buprenorphine;
  • Expanded education about pain management and addiction training in medical schools and residency programs;
  • Building a unified national state-of-the art PDMP with participation from all states, IHS, the VA, etc.

I must give a shout out to our toxicologist colleagues at the American College of Medical Toxicology (ACMT). The ACMT recently published two position statements, the first advocating for the use of buprenorphine in the ED, and the second advocating for the deregulation of buprenorphine. Both were reviewed with several members of our section, and support for those position statements was provided to the ACEP Board. The Board officially endorsed both position statements (along with AAEM for both, and AACT for the latter):

  • Wax, Stolbach, Schwarz, et al. ACMT Position Statement: Buprenorphine Administration in the Emergency Department.  J Med Toxicol. 2019 Jul;15(3):215-216. 
  • Marino, Perrone, Nelson, et al. ACMT Position Statement: Remove the Waiver Requirement for Prescribing Buprenorphine for Opioid Use Disorder.  J Med Toxicol. 2019 Aug 14

Whether speaking on an expert panel for a congressional briefing, meeting with offices such as the Assistant Secretary of Health (ASH) or collaborating in advocacy efforts with organizations like Pew Charitable Trusts, these position statements, endorsed by ACEP, are very powerful and persuasive!  Thanks again to all who wrote, edited, and reviewed the position statements, and thanks to the ACEP Board for providing an expedited endorsement for both.

And the latest news – the Centers for Medicare and Medicaid Services (CMS) is also considering, for future years, to separately pay for the use of MAT in the ED (including initiation of MAT and referral or follow-up care), given that, while OUD can first become noticeable in the emergency department, there is “no specific coding that describes diagnosis of OUD or the initiation of, or referral for, MAT in the emergency department setting.” Clearly ACEP is very supportive of CMS paying for the use of MAT in the ED. Jeffrey Davis of the ACEP DC office is coordinating ACEP communication on this topic, as well.

In summary, there is a lot of legislative and regulatory activity focused on improving access to treatment for OUD. However, carrying any of these efforts across the finish line requires advocacy. Please reach out to your US House Reps and US Senators offices and ask that they co-sponsor the bills. Please make yourself available to the Section and the ACEP DC office, when needed.

Thank you and looking forward to seeing at ACEP19!

Eric Ketcham, MD, FACEP