Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 155 - Licensure Standards for Substance Use Disorder and Problem Gambling Treatment Programs › Rule 641-155.35 - Specific Standards for Opioid Treatment Programs

Current through Register Vol. 47, No. 3, July 24, 2024
All programs that use methadone or other medications approved
				by the Food and Drug Administration under Section 505 of the Federal Food,
				Drug, and Cosmetic Act (
				21
				U.S.C. 355)  and by the state of Iowa for use
				in the treatment of opioid addiction shall comply with this rule, HIPAA, and
				Part II, Department of Health and Human Services, Substance Abuse and Mental
				Health Services Administration, 42 CFR Part 8, Opioid Drugs in Maintenance and
				Detoxification Treatment of Opiate Addiction, effective May 18, 2001.
(1)
Definitions.
"Accredited opioid treatment program "
means
				an opioid treatment program that is the subject of a current, valid
				accreditation from an accreditation body approved by the Substance Abuse and
				Mental Health Services Administration (SAMHSA).
"Certification "
means the process by which
				SAMHSA determines that an opioid treatment program is qualified to provide
				opioid treatment under the federal opioid treatment standards.
"Certification application "
means the
				application filed by an opioid treatment program for purposes of obtaining
				certification from SAMHSA.
"Certified opioid treatment program "
means an
				opioid treatment program that is the subject of a current, valid
				certification.
"Comprehensive maintenance treatment"
means
				maintenance treatment provided in conjunction with a comprehensive range of
				appropriate medical and rehabilitative services.
"Detoxification treatment"
means the
				dispensing of an opioid agonist treatment medication in decreasing doses to an
				individual to alleviate adverse physical or psychological effects incident to
				withdrawal from the continuous or sustained use of an opioid drug and as a
				method of bringing the individual to a drug-free state within such a
				period.
"Interim maintenance treatment"
means
				detoxification treatment for a period of more than 30 days but not in excess of
				180 days.
"Maintenance treatment"
means the dispensing
				of an opioid agonist treatment medication at stable dosage levels for a period
				in excess of 21 days in the treatment of an individual for opioid
				addiction.
"Medical and rehabilitative services"
means
				services such as medical evaluations, counseling, and rehabilitative and other
				social programs (e.g., vocational and educational guidance, employment
				placement) that are intended to help patients in opioid treatment programs
				become or remain productive members of society.
"Medical director "
means a physician who is
				licensed to practice medicine in accordance with Iowa Code chapter 148, 150, or
				150A and who assumes responsibility for administering all medical services
				performed by the program, either by performing them directly or by delegating
				specific responsibility to authorized program physicians and health care
				professionals functioning under the medical director's direct
				supervision.
"Medication unit"
means a facility established
				as part of, but geographically separate from, an opioid treatment program from
				which licensed private practitioners or community pharmacists dispense or
				administer opioid agonist treatment medications or collect samples for drug
				testing or analysis.
"Opiate addiction "
means a cluster of
				cognitive, behavioral, and physiological symptoms in which the individual
				continues use of opiates despite significant opiate-induced problems. Opiate
				dependence is characterized by an individual's repeated self-administration of
				opiates that usually results in opiate tolerance, withdrawal symptoms, and
				compulsive drug-taking. Dependency may occur with or without the physiological
				symptoms of tolerance and withdrawal.
"Opioid agonist treatment medication "
means
				any opioid agonist drug that is approved by the Food and Drug Administration
				under Section 505 of the Federal Food, Drug, and Cosmetic Act (
				21
				U.S.C. 355)  for use in the treatment of
				opiate addiction.
"Opioid drug"
means any drug having an
				addiction-forming or addiction-sustaining liability similar to morphine or
				being capable of conversion into a drug having such addiction-forming or
				addiction-sustaining liability.
"Opioid treatment"
means the dispensing of an
				opioid agonist treatment medication, along with providing a comprehensive range
				of medical and rehabilitative services, when clinically necessary, to an
				individual to alleviate the adverse medical, psychological, or physical effects
				incident to opiate addiction. This term encompasses detoxification treatment,
				short-term detoxification treatment, long-term detoxification treatment,
				maintenance treatment, comprehensive maintenance treatment, and interim
				maintenance treatment.
"Opioid treatment program"
or
"OTP"
means a program or practitioner engaged in opioid
				treatment or interim maintenance treatment.
"Patient"
means any individual who undergoes
				treatment in an opioid treatment program.
"Program sponsor "
means the person
				responsible for the operation of the opioid treatment program and who assumes
				responsibility for all its employees, including any practitioners, agents, or
				other persons providing medical, rehabilitative, or counseling services at the
				program or any of its medication units. The program sponsor need not be a
				licensed physician but shall employ a licensed physician for the position of
				medical director.
"Short-term detoxification treatment"
means
				detoxification treatment for a period not in excess of 30 days.
"State authority"
means the Iowa department of
				public health, division of behavioral health, which regulates the treatment of
				opiate addiction with opioid drugs.
"Treatmentplan "
means a plan which outlines
				for each patient attainable short-term treatment goals that are mutually
				acceptable to the patient and the opioid treatment program and which specifies
				the services to be provided and the frequency and schedule for their
				provision.
(2)
Required approvals.
All opioid treatment programs shall be
			 licensed or approved by the committee and shall maintain all other approvals
			 required by the Drug Enforcement Administration, Substance Abuse and Mental
			 Health Services Administration and the Iowa board of pharmacy in order to
			 provide services.
(3)
Central registry system.
To prevent simultaneous enrollment of
			 a patient in more than one program, all opioid treatment programs shall
			 participate in a central registry as established by the division.
Prior to admission of an applicant to an opioid treatment
				program, the program shall submit to the registry the applicant's name, birth
				date, and date of intended admission, and any other information required for
				the clearance procedure. No person shall be admitted to a program who is found
				by the registry to be participating in another such program. All opioid
				treatment programs shall report all admissions, discharges, and transfers to
				the registry immediately. All information reported to the registry from the
				programs and all information reported to the programs from the registry shall
				be treated as confidential in accordance with HIPAA and DHHS regulations on the
				confidentiality of alcohol and drug abuse patient records, 42 CFR Part
				2.
a.
Definitions.
For purposes of this subrule:
"Central registry "
means the system through
				which the Iowa department of public health, division of behavioral health,
				obtains patient identifying information about individuals applying for
				maintenance or detoxification treatment for the purpose of preventing an
				individual's concurrent enrollment in more than one such program.
"Opioid treatment program "
means a
				detoxification or maintenance treatment program which is required to report
				patient identifying information to the central registry and which is located in
				the state.
b.
Restrictions on disclosure.
A program may disclose patient
			 identifying information to a central registry for the purpose of preventing the
			 multiple enrollment of a patient only if:
(1)
			 The disclosure is made when:
1. The patient
			 is admitted for treatment; or
2.
			 The treatment is interrupted, resumed or terminated.
(2) The disclosure is limited to:
1. Patient identifying information;
			 and
2. Relevant dates of admission.
The program shall inform the patient of the required disclosure
				prior to admission.
c.
Use of information limited to
			 prevention of multiple enrollments.
Any information disclosed to the
			 central registry to prevent multiple enrollments shall not be redisclosed by
			 the registry nor shall such information be used for any other purpose than the
			 prevention of multiple enrollments unless so authorized by court order in
			 accordance with HIPAA and 42 CFR Part 2.
d.
Permitted disclosure by the
			 central registry to prevent a multiple enrollment.
If a program
			 petitions the central registry and an identified patient is enrolled in another
			 program, the registry may disclose:
(1) The
			 name, address, and telephone number of the program in which the patient is
			 currently enrolled to the inquiring program; and
(2) The name, address, and telephone number
			 of the inquiring program to the program in which the patient is currently
			 enrolled. The programs may communicate as necessary to verify that no error has
			 been made and to prevent or eliminate any multiple enrollment.