Ohio Admin. Code 5122-40-04 - General licensure requirements
(A) An alcohol and drug addiction program
desiring to obtain an initial license or renew a license as an opioid treatment
program shall:
(1) Be certified as a provider
pursuant to Chapter 5122-25 of the Administrative Code at a minimum for the
following services:
(a) General services in
accordance with rule
5122-29-03 of the Administrative
Code;
(b) SUD case management
services in accordance with rule
5122-29-13 of the Administrative
Code; and,
(c) Crisis intervention
in accordance with rule
5122-29-10 of the Administrative
Code.
(2) Submit with
the application for initial license or license renewal a licensure fee as set
by paragraph (B)(2) of rule
5122-40-08 of the Administrative
Code;
(3) Submit a renewal
application at least ninety days prior to the expiration of the current
license.
(4) When applying for
renewal licensure, be accredited as an opioid treatment program by an
accreditation body that has been approved by SAMHSA;
(5) Be certified by SAMHSA pursuant to
"certification of opioid treatment programs,"42
C.F.R. Part 8.11;
(6) Have a category III terminal distributor
of dangerous drugs license from the state board of pharmacy pursuant to Chapter
4729. of the Revised Code;
(7) Have
a security and alarm system that is approved by the United States drug
enforcement administration;
(8)
Meet the security requirements for the distribution and storage of controlled
substances as required by
21
C.F.R. 1301.72 to
21 C.F.R.
1301.76;
(9) Operate the program in accordance with 21
C.F.R. 291.505, conditions for the use of narcotic drugs; appropriate methods
of professional practice for medical treatment of the narcotic addiction of
various classes of narcotic addicts under section 4 of the Comprehensive Drug
Abuse Prevention and Control Act of 1970, Pub. L. No. 91-513, 84 Stat. 1236
(Oct. 27, 1970);
(10) Have a
program sponsor who has signed and submitted SAMHSA form SMA-162, application
for certification to use opioid drugs in a treatment program under
42 CFR
8.11;
(11) Be in good standing with the state board
of pharmacy, centers for medicare and medicaid services, Ohio department of
medicaid,, and the United States drug enforcement administration;
(12) Be in good standing as defined by
division (C)(1) of section 5119.391 of the Revised
Code until June 29, 2019 and division (C)(1) of section
5119.37 of the Revised Code
after June 29, 2019;
(13) Demonstrate the ability to meet the
standards of medical care for opioid treatment services established by the
American society of addiction medicine (ASAM) criteria, third edition (2013),
or other nationally recognized standards organization selected by the
director;
(B) Geographic
restrictions:
(1) A program applying for an
initial license shall not be issued a license if the provider is requesting an
initial license for a particular location that is located on a parcel of real
estate that is within a radius of five hundred linear feet of the boundaries of
a parcel of real estate having situated on it a public or private school, child
day-care center licensed under Chapter 5104. of the Revised Code, or
child-serving agency regulated by the department under Chapter 5119. of the
Revised Code.
(2) The five-hundred
foot restriction may be waived if the program obtains a letter of support from
each public or private school, licensed child day-care center, or other
child-serving agency within the five hundred linear foot radius of the location
where the opioid treatment program is to operate.
(3) Programs will perform their due diligence
to evaluate this criterion before submitting the application for
licensure.
(4) If a determination
was not applied for and made by the program prior to submitting a license
application pursuant to section 5119.392 of the
Revised Code until June 29, 2019 or section
5119.371 of the Revised Code
after June 29, 2019, the department, upon
receiving a license application, shall proceed to make the determination if
there is such a public or private school, licensed child day-care center, or
other child-serving agency regulated by the department under Chapter 5119. of
the Revised Code within the five-hundred foot radius of the location listed on
the application and issue a declaration of its findings in accordance with
section 5119.392 of the Revised Code until June 29,
2019 or section
5119.371 of the Revised Code
after June 29, 2019.
(5) For license renewals, the geographic
restrictions of this paragraph shall not apply pursuant to division (K) of
section 5119.391 of the Revised Code until June 29,
2019, or section
5119.37 of the Revised Code
after June twenty-ninth, so long as the
program remains continuously licensed.
(C) An opioid treatment provider shall inform
the department of any adverse action or proposed adverse action that is issued
to the provider or owner, or is issued to any other program, corporation,
entity or partnership with which the opiate treatment program's sponsor,
medical director, administrator or a principal is associated. Adverse action is
defined as a notice issued by a state, province federal or similar licensing or
regulatory authority to deny, revoke, suspend, place on probation or take
similar action against a provider's license, certificate or other approval to
operate an opioid treatment program. Notice provided to the department shall
consist of a copy of the notice of adverse action or proposed adverse action,
and all of that opioid treatment program's compliance or monitoring reports
issued for the prior three-year period. The opioid treatment provider shall
provide this information to the department at the following times:
(1) At the time of initial or renewal
application; and,
(2) Within seven
days of receipt of notice.
(D) Upon receipt of an application, the
department shall review the materials to determine if they are complete. If an
application is incomplete, the department shall notify the applicant of
corrections or additions needed, and may return the materials to the applicant.
Incomplete materials shall not be considered an application for licensure, and
return of the materials or failure to issue a license shall not constitute a
denial of an application for licensure.
Notes
Promulgated Under: 119.03
Statutory Authority: R.C. 5119.37
Rule Amplifies: R.C. 5119.37
Prior Effective Dates: 07/01/2001, 10/01/2003, 06/01/2017, 01/01/2019, 06/11/2021
Promulgated Under: 119.03
Statutory Authority: 5119.37
Rule Amplifies: 5119.37
Prior Effective Dates: 07/01/2001, 10/01/2003, 06/01/2017, 01/01/2019
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