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Issue Brief

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 Issue Brief: CMS Proposes Slight Payment Increase for PHPs and CMHCs in 2020

The Centers for Medicare and Medicaid Services (CMS) has proposed a hospital-based partial hospitalization program (PHP) payment rate of $228.20 for 2020, up from the 2019 rate of $220.86, in the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System (OPPS/ASC) proposed rule the agency released on July 29.

CMS also proposed an increase for community mental health centers (CMHCs), which could see a payment rate of $124.59 in 2020 if the rule is made final. By comparison, CMHCs received a payment rate of $120.58 in 2019.

The rates set in the proposed CY 2020 rule are not based on the most recent average cost data from the PHP program, a deviation from CMS’ long-standing policy. When CMS calculated the average PHP program cost for the CY 2020 proposed rule, the agency found it had decreased by nearly 15 percent for CMHCs and 11 percent for hospitals-based PHPs.

After finding this decrease, CMS reviewed the data sets and found that a single provider in the CMHC set and a single provider in the hospital-based set had such dramatically lower-reported costs that it significantly skewed the average cost for both data sets.

Because the lower average costs were the result of single providers and could significantly reduce access for beneficiaries, CMS decided to use the CY 2019 cost average as a floor for both type of PHP rates in the CY 2020 rule. If not for this change, the rate for both types of PHPs would have been significantly lower than what CMS proposed in the rule.

It is important to note that CMS stressed that it does not intent to carry this policy forward: “To be clear, this policy would only apply for the CY 2020 rate setting,” the agency said in the rule.

CMS will accept comments on the CY 2020 proposed rule until September 27.

CY 2020 Rates
Level 1 Health and Behavior Services                                                         $28.59
Level 2 Health and Behavior Services                                                         $81.06
Level 3 Health and Behavior Services                                                         $130.27
Partial Hospitalization (3 or more services) for CMHCs                               $124.59
Partial Hospitalization (3 or more services) for Hospital-based PHPs         $228.20

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NABH Issue Brief: CMS Addresses OUD Treatment in OTPs and Office Settings in Proposed Rule

The Centers for Medicare and Medicaid Services (CMS) on Monday issued a proposed rule for establishing a Medicare Part B benefit and payment bundles for opioid use disorder (OUD) treatment services in opioid treatment program (OTP) settings and new HCPCS codes and bundled rates for office-based treatment of OUD.

OTP Bundled Payment

The proposal implements Section 2005 of the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act.

The rule proposes:

  • A definition of OUD treatment services and OTPs, including an explanation that services include access to all FDA-approved medications, counseling and therapy, and toxicology testing;
  • Enrollment policies that align with SAMHSA OTP regulation and that do not have additional conditions of participation;
  • Bundled payment methodologies that separate drug from non-drug treatment components, account for different medications and variable intensity of services, provide for service add-ons and partial- and full-billing for weekly episodes;
  • Use of audio-video communication technology; and
  • Zero beneficiary cost-sharing requirement for a time-limited period.
Office-based Care Bundled Payment

The agency also proposed a bundled payment for office-based OUD treatment services, to encourage the expansion of access to OUD care, including:

  • Coverage of OUD management, care coordination, psychotherapy, and counseling; medication to be billed and reimbursed under existing Medicare Part B or D; toxicology testing to be billed under Clinical Lab Fee Schedule;
  • Bundled payment methodologies that are based on monthly billing cycles to better align with office-based practices; one bundle for the initial month of treatment that is more service-intensive; and a second bundle for subsequent “maintenance months,” service add-on codes, and not restricted to addiction specialists;
  • Three new HCPCS codes to Category I of the list of Medicare telehealth services for office-based substance use disorder (SUD)/OUD services, permits a patient’s home as a telehealth originating site; and
  • No changes to cost-sharing.
Emergency Departments

Also of interest, the proposed rule requests information on emergency department practice patterns related to the initiation and use of MAT, and referral or follow-up care, for developing such bundles in future rulemaking.

Comments are due September 27, 2019. NABH has engaged a consulting firm to help analyze the proposed bundled payment methodology and payment rates, and the association will submit comments.

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