Chapter 38 - Internet Eligible Controlled Substance Provider Designation

3-38.1  INTRODUCTION

1. Purpose.  To facilitate access to Medication Assisted Treatment (MAT) using telemedicine models, this policy establishes the requirements for the Indian Health Service (IHS) practitioner designation as an Internet Eligible Controlled Substance Provider (IECSP) in accordance with the Ryan Haight Online Pharmacy Consumer Protection Act of 2008.
2. Scope. This policy pertains to practitioners that possess an active waiver to prescribe buprenorphine as detailed in the Drug Addiction Treatment Act of 2000 (DATA 2000) or the Comprehensive Addiction Recovery Act of 2016 that are employees or contractors of the IHS or working for an Indian tribe or tribal organization under its contract or compact with the IHS under the Indian Self-Determination and Education Assistance Act (ISDEAA).
3. Background.  The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 seeks to prevent the illegal distribution and dispensing of controlled substances via the Internet. The Act was created to reduce harm from internet pharmacies. However, several provisions included in this Act create potential barriers for IHS programs that utilize telemedicine models. The Act emphasizes the requirements surrounding "dispensing controlled substance prescriptions pursuant to a valid prescription for a legitimate medical purpose by a practitioner acting in the usual course of professional practice." Additionally, it requires an in-person evaluation before a prescription for a controlled substance can be delivered or dispensed via means of the Internet (broadly defined to include almost all forms of electronic communication). There are seven telemedicine exceptions defined within the Act.

   The specific IHS telemedicine exception includes "a practitioner":

   1. Who is an employee or contractor of the IHS, or is working for an Indian tribe or tribal organization under its contract or compact with the IHS under the ISDEAA;
   2. Who is acting within the scope of the employment, contract, or compact described in clause (1); and
   3. Who is designated as an IECSP by the Secretary of Health and Human Services (HHS).
4. Authorities.
   1. Indian Health Care Improvement Act (IHCIA), 25 United States Code (U.S.C.) § 1661(c)
   2. Controlled Substance Act §311(g)(2) (21 U.S.C.§831(g)(2))
   3. ISDEAA, 25 U.S.C. §§ 450 et seq.
5. Policy. The IHS Director has the delegated authority to make the designation of "Internet Eligible Controlled Substance Provider" for eligible IHS prescribers serving remote populations where access to medical services is deemed to be limited.
6. Definitions.
   1. Medication Assisted Treatment (MAT). The use of medications, in combination with counseling and behavioral therapies, to provide a "whole-patient" approach to treatment of opioid use disorders (OUD).
   2. Remote Location. Generally defined as meeting geographic Primary Care Health Professional Shortage Area (HPSA) criteria (HPSA Score > 15—or 75% unmet need) or any other areas determined by the IHS Director to be sufficiently remote related to geography and/or access to services.
   3. Telemedicine. The practice of medicine in accordance with applicable Federal and State laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system referred to in section 1395m(m) of title 42.
   4. Telepharmacy. The delivery of pharmaceutical care, including the dispensing of medications, via telecommunications to patients in locations where they may not have direct contact with a pharmacist. Telepharmacy is one type of telehealth.

3-38.2  RESPONSIBILITIES

1. Director, IHS. The Director, IHS, is responsible for exercising the delegated authority to designate eligible prescribers as IECSPs, as stated in the IHCIA, 25 U.S.C. § 1661(c).
2. Chief Medical Officer. The IHS Chief Medical Officer (CMO) is responsible for review of IECSP applications for completeness and eligibility requirements and forwarding recommendation for approval to the IHS Director.
3. Area Chief Medical Officer (or Designee). The Area CMO is responsible for reviewing submitted IECSP applications for completeness, level of service determination, and eligibility for designation and forwarding such to the IHS CMO for consideration.
4. IHS Facility Governing Body. The governing body is the only authority that can grant clinical privileges in accordance with requirements outlined in local medical staff bylaws. The governing body has the ultimate authority and responsibility for the initial and ongoing oversight and delivery of health care rendered by licensed independent practitioners and other practitioners who are credentialed and privileged through the medical staff process.

3-38.3  REQUIREMENTS FOR DESIGNATION AS AN IHS IECSP

1. Substances/Conditions. The below constitutes the full listing of available controlled substances, conditions and patients considered for treatment under this policy:
   1. Partial opioid agonists, Drug Enforcement Agency (DEA) schedules III-IV only;
   2. Medication Assisted Treatment for patients with a diagnosis of opioid use disorder; and
   3. Patients eligible for IHS services.
2. Practitioner Requirements.
   1. Active and unrestricted State license,
   2. Local Medical Staff privileges under an appropriate scope of practice, and
   3. Active DEA registration to prescribe controlled substances, including an active DATA 2000 waiver to conduct maintenance and detoxification treatment using specifically approved schedule III, IV, or V narcotic medications.
3. Application.
   1. Applicants seeking approval for IHS Designation as an IECSP will provide the following information:
      1. A description of telemedicine services;
      2. A justification for remote designation;
      3. A description of the dispensing model (e.g., Directly Observed Therapy vs. dispensing a take-home supply);
      4. A description of patient adherence monitoring strategy (e.g., urine drug screens, Prescription Drug Monitoring Program queries, etc.) and frequency;
      5. A description of available mechanisms and strategies to assess the patient’s health history and current physical condition; and
      6. A copy of the Tribe’s Annual Funding Agreement under the ISDEAA that includes provision of MAT services (if applicable).
   2. A copy of the following documents:
      1. Curriculum vitae;
      2. All active and inactive State licenses;
      3. DEA registration, including DATA 2000 waiver number with patient limits; and
      4. Copy of approved local clinical privileges inclusive of MAT.
4. Review & Designation.
   1. Initial Review and Endorsement by Area CMO (or Designee). The completed application with supporting documentation for IHS designation as an IECSP is reviewed by the Area CMO for completeness, level of service determination, and eligibility for designation. A recommendation to issue the designation or deny the request is made within 30 days of receipt of completed application. A recommendation to approve the designation is provided to the IHS CMO for consideration and action. A written denial notice will be furnished to the applicant within 15 days of negative determination to include the reason for denial and recommended next steps for a successful application, if applicable.
   2. IHS CMO Recommendation. The completed application and Area CMO recommendation is reviewed for completeness and eligibility. The IHS CMO will then make a recommendation to approve or deny the request to the IHS Director for consideration.
   3. IHS Director Approval. Approval for designation is issued via memo to the prescriber. A copy of the memo is provided to the Area CMO for archive.
   4. IHS Director Denial. A written denial notice will be furnished to the applicant within 15 days of negative determination to include the reason for denial and recommended next steps for a successful application.
   5. Secretary of HHS Notification. A listing of active IHS-approved IECSPs is provided annually by IHS to the Secretary, HHS.
5. On-Going Review and Reporting Requirements. The IECSP will furnish an annual report of the below criteria to the Area CMO for review and recommendation:
   1. Number of MAT patients served using the telemedicine model; and
   2. Total number of controlled substance prescriptions issued by IHS IECSP for treatment of OUD by active ingredient and formulation (e.g., buprenorphine film, etc.).
6. Biennial Review. The IECSP is required to initiate a biennial review for extension of their designation to the Area CMO. The Area CMO will review the extension request and annual reports to issue a recommendation to continue the designation as an IHS IECSP or deny the request. The recommendation to approve or revoke the designation is provided to the IHS CMO for extension consideration.
7. Termination of Designation. Requests for termination of designation should be submitted to the Area CMO by:
   1. The designated IECSP pursuant to changes in program or level of service; or
   2. The CEO/Tribal Health Director (or designee) if due to separation from Federal or tribal service.