Changing Program Sponsor or Medical Director: The Three-Week Notice

Leadership turnover at an opioid treatment program (OTP) is a regulatory event. Part 8 requires that "OTPs shall notify the Secretary in writing within 3 weeks of any replacement or other change in the status of the program sponsor or medical director" (42 CFR 8.11(e)(5)). Three weeks passes quickly when a medical director resigns on short notice or a parent company restructures, so the process should be written down before it is needed.

Who are the program sponsor and the medical director?

Every OTP must "formally designate a program sponsor and medical director" (42 CFR 8.12(b)(1)).

• Program sponsor: "the person named in the application for certification described in § 8.11(b) as responsible for the operation of the OTP and who assumes responsibility for all its employees, including any practitioners, agents, or other persons providing medical, behavioral health, or social services at the program or any of its medication units." The sponsor "need not be a licensed physician but shall ensure that an actively licensed physician occupies the position of medical director" (42 CFR 8.2). The sponsor agrees on the OTP's behalf to follow Part 8 (8.12(b)(1)).
• Medical director: "a physician, licensed to practice medicine in the jurisdiction in which the OTP is located, who assumes responsibility for all medical and behavioral health services provided by the program." The medical director may delegate specific duties to other physicians and licensed practitioners, but delegation "will not eliminate the medical director's responsibility" (8.2), and the medical director is responsible for the OTP's compliance with federal, state and local law (8.12(b)(2)).

How is the change reported to SAMHSA?

On Form SMA-162 through the SAMHSA OTP Extranet. SAMHSA's "Notify SAMHSA of Program Changes" page lists "Change of program sponsor" and "Change of medical director" among the changes existing OTPs must report "within three weeks," and it requires "a separate Form 162 ... for each change." If the sponsor and the medical director change together, that is two forms.

For a new medical director, SAMHSA asks for:

• A copy of the medical director's DEA registration.
• A copy of the medical director's state license.
• The medical director's curriculum vitae.
• A written statement that the medical director will work only at this facility, or, if the person also directs another treatment program, a written justification of how that is feasible, addressing time spent treating unrelated patients and serving on boards and committees.

Only the program sponsor may sign and submit an SMA-162, and the sponsor e-signs through a link SAMHSA emails after submission. When the sponsor is the one changing, settle who the incoming sponsor is and make sure that person has an individual Extranet account before the three weeks run out. SAMHSA says existing sponsors "should have an individual SAMHSA OTP Extranet account" and lists a help desk for access.

Is a change of ownership handled the same way?

No. SAMHSA's page lists change of ownership, program name changes and closures as changes reported to the Division of Pharmacologic Therapies by email or to the state's SAMHSA compliance officer, not on the SMA-162. An ownership change often brings a new sponsor too, which is an SMA-162. See buying a treatment program.

Does Medicare need to know?

If the OTP is enrolled in Medicare, yes. The program sponsor and medical director are reported on the CMS-855A or 855B as managing employees (42 CFR 424.67(b)(5)). Medicare's reporting rule for these providers requires reporting "within 30 days for a change of ownership or control (including changes in authorized official(s) or delegated official(s))," and "all other changes to enrollment must be reported within 90 days" (42 CFR 424.516(e)). The OTP's staffing standards also apply to the incoming medical director: an OTP may not employ or contract with a prescriber convicted in the past 10 years of a felony CMS deems detrimental, or anyone revoked from Medicare or on the preclusion list (424.67(b)(6)). Check before the hire, not after. Our post on Medicare enrollment for OTPs covers the standards.

What about the state and DEA?

State OTP rules commonly require their own notice of leadership changes, and some look at the new leaders' history. Ohio, for example, issues an OTP license only if the provider and its owners, sponsor, medical director, administrator and principals have been in good standing at every other location where they have run an OTP during the prior three years (Ohio Rev. Code 5119.37(C)(1)). Check your state's rule for its notice deadline. On the DEA side, the narcotic treatment program registration belongs to the program, but the signer for future DEA applications must be an officer, partner or the individual registrant (21 CFR 1301.13(j)), so update who signs.

Which steps keep a transition clean?

1. Keep a current file on the medical director: DEA registration, state license and CV, so a successor's file can be assembled the same week.
2. Name an interim medical director who meets the Part 8 definition and state requirements, so the position is never empty.
3. Put the three-week SAMHSA deadline, the Medicare deadlines and the state deadline on one calendar the day the change is known.
4. Confirm the incoming sponsor's Extranet access and the incoming medical director's Extranet account for exception requests.
5. Update policies that name the medical director's delegations.

How do we help?

We prepare the SMA-162 attachments, the Medicare change information and the state notice, and track all three deadlines, under our Renewal Tracking ($299 per license, certificate or registration per year) or, when ownership changes too, our Ownership Change or Relocation service ($795). The sponsor signs and submits the SMA-162; the authorized or delegated official signs Medicare changes. See pricing.