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DEA Eases Regulations for Mobile Methadone

DEA Eases Regulations for Mobile Methadone

The Drug Enforcement Administration (DEA) on Feb. 26 proposed a regulation that revises the Controlled Substances Act (CSA) to permit narcotic treatment programs (NTPs)—opioid treatment programs, detoxification services that use methadone, and compounders— to operate mobile components, or mNTPs, without separate registrations.

The rule also proposes requirements related to security, recordkeeping, reporting, and inventory. The purpose of the rulemaking is to address the opioid epidemic by expanding access to methadone treatment, especially for residents of rural and underserved communities.

Background

Currently, each mobile component of an NTP must be separately registered, as the components dispense narcotic drugs regularly and therefore constitute a “principal place of business” or a “professional practice.” The CSA permits waivers to this requirement in instances that serve public health. The DEA had provided waivers on an ad hoc basis until a moratorium was implemented in 2007; after that, there was a subsequent decline in the number of operational mobile components.

The proposed rule obviates the need for ad hoc waivers by establishing mobile unit operations as a permissible “coincident activity” under the CSA with prior approval of a local DEA office.

Selected Summary of Requirements

  • Registration
    • Registrants notify the local DEA office in writing about intent to operate an mNTP and receive explicit written approval prior to operation.
    • The mNTP functions within the same states that the NTP is registered.
      • Practitioners maintain a DEA license in each state where they dispense controlled substances.
    • Vehicles possess valid county/city and state information on file at the NTP.
    • mNTPs are a controlled premise subject to administrative inspection; registrants provide licensing and registration to DEA at time of the inspection and before transportation of substances.
    • mNTPs may not serve as hospitals, long-term care facilities, emergency medical service vehicles, or patient transportation.
  • Security
    • Storage area must not be accessible from the outside of the mNTP vehicle.
    • Substances are secured in a locked safe:
      • with safeguards against forced entry, lock manipulation, and radiological attacks;
      • cemented to the floor or wall such that it cannot be readily removed;
      • equipped with an alarm system that can directly signal a protection company, local or State policy agency, or 24-hour registrant-operated control station, or other DEA Administrator approved protection.
    • Transportation personnel retain control over the controlled substances when transferring, traveling, and dispensing the substances.
    • mNTP is returned to registration location after operations are completed.
      • Substances are removed and secured within the registered NTP location.
      • Protocols allow for securing substances if the component is disabled.
      • Substances are removed and secured if the vehicle is taken to an automotive shop for repair.
    • For security breaches such as theft and loss, the NTP must abide by theft and loss reporting requirements.
    • NTPs follow state and federal regulations or whichever is more stringent and consults with State Opioid Treatment Authority to ensure compliance.
  • Other security controls
    • Ensure proper security measures and patient dosage, e.g., enrolled individuals wait in an area of the mNTP that is physically separated from the narcotic storage and dispensing area by a physical entrance.
      • If no seating is available, patient will wait outside of the mNTP.
    • mNTPs will abide by existing HHS standards for quantity of substances provided for unsupervised use.
    • Degree of security is at DEA discretion, based on factors including the location, number of patients, staff, and security guard.
    • Disposal of controlled substances is done consistent with all applicable laws and regulations.
    • Distribution and delivery of controlled substances to mNTP is only done at the registered location. Persons delivering narcotic drugs to mNTP may not:
      • Receive or deliver controlled substances to another mNTP or other entity while deployed outside the registered location.
      • Act as reverse distributors (or collectors).
  • Records and Reports
    • mNTP records are maintained in a paper dispensing log at the registered NTP, or
    • Use of automated/computerized system if the system:
      • maintains the same information as required for paper records;
      • has the capability to produce hard copies of the dispensing records;
      • the mNTP prints each day’s dispensing log which is initialed by individuals who dispense the medication;
      • produces accurate summary reports for any time frame requested by DEA in an investigation;
      • Hard copies of summaries are systematically organized at the NTP;
      • Computer generated information has off-site back-up;
      • DEA approves of the system.
    • mNTP maintain records for two years, or longer if required by the state.

Please contact Sarah Wattenberg, NABH’s director of quality and addiction services, at sarah@nabh.org, or 202.393.6700, ext. 114.

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NABH 2020 Directory Features Essential Behavioral Healthcare Sources

WASHINGTONFeb. 26, 2020 /PRNewswire/ — The National Association for Behavioral Healthcare (NABH) is pleased to share its online Membership Directory with the public for the first time.

NABH’s Membership Directory is designed to help clinicians, hospital admissions staff, employee assistance directors, school counselors, policymakers, journalists, patient advocates, and families identify systems and facilities that provide essential behavioral healthcare services across the United States.

Read more at PR Newswire

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A National Plan to Address Opioid Misuse

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Kirsten Beronio Joins NABH as Director of Policy and Regulatory Affairs

WASHINGTONFeb. 24, 2020 /PRNewswire/ — Kirsten Beronio has joined the National Association for Behavioral Healthcare (NABH) as director of policy and regulatory affairs, effective Feb. 24.

Kirsten Beronio comes to NABH with more than 20 years of experience developing mental health and substance use disorder policy in leadership positions she has held in the legislative and executive branches of the federal government and at a leading mental health advocacy organization.

“We are excited to welcome someone with the depth and breadth of behavioral healthcare policy experience that Kirsten brings,” said Shawn Coughlin, president and CEO at NABH. “Kirsten’s background in developing, implementing, and advocating for policies that help people struggling with mental health and substance use disorder positions her well for this role, and we are thrilled to have her join our team.

Learn more at PR Newswire

 

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MHLG Supports the Implementation of the National Suicide Hotline Improvement Act of 2018

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NABH Supports Nutrition Care Act

 

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White House Proposes Changes IMD Exclusion in 2021 Budget

The White House on Monday released a $4.8 trillion budget for 2021 that would modify Medicaid’s Institutions for Mental Diseases (IMD) exclusion to provide states with flexibility to provide inpatient mental health services to beneficiaries with serious mental illness (SMI).

The budget requests $94.5 billion for HHS, a 10-percent decrease from the 2020 enacted level. Although Congress is likely to reject President Trump’s proposal, the budget is significant for outlining the president’s top policy priorities as he seeks re-election in November. Notably for NABH, those priorities address mental health and addiction treatment services.

These provisions include changes to the IMD exclusion, which under current law states Medicaid cannot pay for certain inpatient stays at IMDs. The president’s budget would provide more than $5 billion in new federal funding to states to ensure the full continuum of care exists to provide help to people with SMI. These changes—which appear in summary tables at the end of the budget proposal—would exempt Qualified Residential Treatment Programs (QRTPs) from the IMD exclusion.

The budget also includes $225 million for Certified Community Behavioral Health Clinics (CCBHC) expansion grants, and would extend, through 2021, the CCBHC Medicaid demonstration programs to improve community mental health services for the eight states participating currently in the demonstration. In addition, the White House has proposed $25 million to expand primary healthcare services to address homelessness. These provisions, together with the changes to the IMD exclusion, are “part of a comprehensive strategy that includes improvements to community-based treatment,” the budget proposal noted.

Meanwhile, the president’s 2021 budget would continue 2020 funding to expand medication assisted treatment (MAT) from a small pilot program to half of all eligible Bureau of Prisons (BOP) facilities and provide an additional $37 million to complete MAT expansion to all eligible BOP facilities.

NABH will continue to analyze the Trump administration’s budget proposal and keep NABH apprised of any additional details regarding the IMD exclusion, MAT funding, and other topics related to the association’s policy priorities.

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ONDCP Issues 2020 National Drug Control Strategy and Treatment Plan

The Office of National Drug Control Policy (ONDCP) has issued its 2020 National Drug Control Strategy (Strategy) and accompanying National Treatment Plan (NTP) that includes action items for federal agencies and external stakeholders to increase access to care and close the addiction treatment gap.

The Strategy is presented using the domains of prevention, treatment and recovery, and supply-side strategies for reducing the availability and consumption of illicit drugs. These domains are established as ‘pillars’ that undergird the federal initiatives of expanding the early intervention, treatment and recovery infrastructure; improving the delivery system; and improving quality.

Specifically, the NTP calls for treatment expansion and improved quality by:

  • Developing protocols for medically managed withdrawal including MAT to prevent relapse and promote stabilization;
  • Increasing emergency department use of addiction medicine specialty services;
  • Exploring the inclusion of stimulant disorder treatment in opioid treatment programs;
  • Increasing access to all medication and psychosocial services, promoting syringe exchange, interim methadone, mobile methadone vans, and peer outreach. One objective of the federal Performance and Reporting System is to make sure 100% of all specialty providers offer MAT by 2020;
  • Adopting model state specialty SUD treatment licensing laws;
  • Developing mobile and online platforms with updated information on treatment slot availability with online appointment capacity;
  • Encouraging public and private payers to cover comprehensive services and improve reimbursement rates where out-of-network rates are higher;
  • Urging providers to subsidize and provide treatment scholarships; and
  • Exploring the idea of developing national consensus standards for addiction treatment to consolidate treatment quality standards.

If you have questions about the Strategy or NTP, please contact Sarah Wattenberg, NABH’s
director of quality and addiction services.

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