On Wednesday, February 26, the Drug Enforcement Administration (DEA) published in the Federal Register a notice of proposed rulemaking (NPRM) entitled, “Registration Requirements for Narcotic Treatment Programs with Mobile Components.” First sent to the White House Office of Management and Budget in October 2019 for review, the release of the NPRM signals continued efforts by the Trump administration to facilitate greater access to medication-assisted treatment (MAT), including communities where narcotic treatment programs (NTPs) are scarce, or even nonexistent.
NPRM Background: Enhanced Access to Treatment and Cost Savings
The NPRM proposes amending the federal Controlled Substances Act (CSA) to waive future requirements for DEA registrants to register individual NTPs operating with a mobile component (also referred to as a conveyance). Pursuant to federal statute, 21 U.S.C. 822(d), DEA Acting Administrator Uttam Dhillon is authorized to issue regulations that forego traditional registration requirements in favor of efforts with clear public health and patient safety benefits. The proposed rule is largely based upon this authority.
As currently structured under DEA statute, 21 CFR 1301.12, each “principal place of business or professional practice” must be registered as part of the dispensation of controlled substances, schedule II-IV. Once implemented, the proposed rule would circumvent the need for further clarification around the definition of a DATA 2000-waivered providers’ “principal place of business or professional practice” and level of engagement.
Of more than 1,700 NTPs registered with the DEA nationwide, approximately one percent – 19 in total – have registered to operate a mobile component within the last five years, and only eight are currently in operation. The proposed rule would consider operation of a mobile NTP as a “coincident activity” of an already registered program. However, the NPRM does not address the prospect of registrants providing care — and dispensing controlled substances — outside the state in which they are registered.
These mobile components would produce modest expected costs savings of approximately $1.35 million within five years of implementation, while also introducing opportunities to provide care outside of traditional, brick-and-mortar sites. Anticipated costs savings are based upon comparison of purchase, rental, labor and registration fees for both office-based and vehicle-based care modules. Assuming a return to at least 19 mobile NTP registrants, the DEA estimates that net costs savings over a period of five years will range between $3.5 and $4 million.
Only one instance of theft or diversion of controlled substances from a mobile NTP was reported to DEA from 2005 through 2017, from which DEA cites a minimal risk under the proposed rule. Registrants that pursue mobile NTPs must comply with stringent security, recordkeeping, reporting and inventory requirements consistent with dispensation from registered locations.
This regulatory change provides manifest advantages in patient care and access to treatment, as well. With an estimated 90% of NTPs located in urban America, mobile NTPs would bridge treatment deserts and other underserved areas. For patients that require daily medication administration, traveling far distances or long periods of time to receive care may hinder therapy adherence or long-term recovery efforts. In some instances, reports indicate that distance to care is a deciding factor around access to potentially life-saving interventions.
Aligning Federal Efforts to Improve Treatment Access
DEA’s efforts to provide additional flexibility around the provision of MAT aligns closely with the release of the White House Office of National Drug Control Policy’s National Drug Control Strategy released earlier this month. Addressing two core priorities within the treatment response — enhancing evidence-based addiction treatment and eliminating barriers to treatment availability — the NPRM will further the administration’s efforts to reach several performance metrics at the core of the National Drug Control Strategy.
The release of the National Drug Control Strategy coincided with the first iteration of the National Treatment Plan for Substance Use Disorder, a comprehensive document outlining particular efforts to improve access to evidence-based treatment required by the October 2018 SUPPORT for Patients and Communities Act (P.L. 115-271). In its entirety, the National Treatment Plan promotes a triphasic approach, referenced as pillars, to address existing treatment gaps across 22 areas of interest. Those pillars are:
- Efforts related to early intervention, treatment and recovery support services infrastructure.
- Delivery systems, provider efforts, and services for individuals with substance use disorders, including special populations.
- Treatment quality.
The NPRM is referenced specifically in Pillar #2 under item 18(e). Coupled with efforts to increase outreach and patient exposure to evidence-based treatment, implementation of this regulatory change would enable health care providers to better serve communities and close the treatment gap that left more than 17.5 million individuals with a substance use disorder without treatment in 2018.
While efforts to improve MAT access are likely to be well received by patients and health care providers alike, it is too early to determine the willingness of registrants to proceed in offering mobile NTPs. There is clear recognition in academic literature referencing disparate access to MAT throughout the United States — something that may be more closely equalized in allowing for treatment modalities to be taken to the patient. Given the fact that less than 0.5% of all registrants currently operate a mobile NTP, the removal of registration requirements for secondary sites and equivalent compliance requirements could spur reinvestment into mobile components in lieu of subsequent brick-and-mortar sites.
Public comment submitted via Regulations.gov will be accepted for 60 days upon publication in the Federal Register, ending on Monday, April 27.