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.
(4)
Admission
requirements.
a. Prior to or at the
time of a patient's admission to an opioid treatment program, the program shall
conduct a comprehensive assessment so as to determine appropriateness for
admission.
b. The program shall
verify, to the extent possible, the patient's name, address, and date of
birth.
c. The program physician
shall determine and document in the patient's record that the patient is
physiologically dependent on narcotic substances and has been physiologically
dependent for at least one year prior to the patient's admission. A one-year
history of addiction means that the patient was physiologically dependent on a
narcotic at a time one year before the patient's admission to a program and was
addicted for most of the year preceding admission.
(1) When physiological addiction cannot be
clearly documented, the program physician or an appropriately trained staff
member designated and supervised by the physician shall record in the patient's
record the criteria used to determine the patient's current physiologic
dependence and history of addiction. In the latter circumstance, the program
physician shall review, date, and countersign the supervised staff member's
evaluation to demonstrate the physician's agreement with the evaluation. The
program physician shall make the final determination concerning a patient's
physiologic dependence and history of addiction. The program physician shall
also sign, date, and record a statement that the physician has reviewed all the
documented evidence to support a one-year history of addiction and current
physiologic dependence by the patient and that in the physician's reasonable
clinical judgment the patient fulfills the requirements for admission to
maintenance treatment. Before the program administers any medication to the
patient, the program physician shall complete and record the statement
documenting the patient's addiction and current physiologic dependence.
(2) When a patient has voluntarily
left an opioid treatment program in good standing and seeks readmission within
two years of discharge, the program shall document the following information
about the patient:
1. Prior opioid treatment
of six months or more; and
2. That
in the physician's medical judgment, treatment of the patient is warranted.
Such documentation shall be entered in the patient's record by the program
physician.
d.
The program shall collect a drug screening sample for analysis. Where
dependence is substantially verified through other indicators, a negative drug
screen will not necessarily preclude admission to the program.
e. Prior to a patient's admission, the
program shall confirm with the central registry that the patient is not
currently enrolled in another opioid treatment program.
f. If a potential patient has previously been
enrolled in another program, the admitting program shall request from the
previous program a copy of the patient's assessment data, treatment plan, and
discharge summary including the type of or reason for discharge. All programs
subject to these rules shall promptly respond to such a request upon receipt of
a valid release of information.
g.
A person under the age of 18 is required to have had two documented attempts at
short-term detoxification or drug-free treatment to be eligible for maintenance
treatment. A one-week waiting period is required after such a detoxification
attempt, however, before an attempt is repeated. The program physician shall
document in the patient's record that the patient continues to be, or is again,
physiologically dependent on narcotic drugs.
h. Program staff shall ensure that a patient
is voluntarily participating in the program, and the patient shall sign a
Consent to Treatment Form.
i.
Pregnant patients may be admitted to opioid treatment in accordance with the
following provisions:
(1) Evidence of current
physiological dependency is not needed if the program physician certifies the
pregnancy and, in the physician's reasonable judgment, finds treatment to be
justified. Documentation of all findings and justifications for admission shall
be documented in the patient's record by the program physician prior to the
administration of the initial dose of medication.
(2) Pregnant patients shall be offered
comprehensive prenatal care. If the program cannot provide prenatal services,
the program shall assist the patient in obtaining such services and shall
coordinate ongoing care with the collateral provider.
(3) The program physician shall document that
the patient has been informed of the possible risks to the unborn child from
the use of medication and the risks of continued use of illicit
substances.
(4) Should a program
have a waiting list for admission to the program, pregnant patients shall be
given priority.
(5)
Placement, admission and
assessment. The program shall have written criteria for considering an
individual for placement and admission. In addition, the program shall maintain
current procedures to ensure that patients are admitted to maintenance
treatment by qualified staff who have determined by using accepted medical
criteria, such as those outlined in the Diagnostic and Statistical Manual for
Mental Disorders, that the person is currently addicted to an opioid drug.
a. The program physician or a designee who is
a qualified medical professional shall complete a medical evaluation and a
current psychological/mental status evaluation of the patient prior to the
administration of the initial dose of medication. If the history and current
psychological/mental status evaluation is completed by an individual other than
the program physician, the program shall document in the patient's case record
that this information was reviewed by the program physician prior to
administration of the initial dose of medication.
b. The medical evaluation of the patient
shall include, but not be limited to:
(1) A
complete medical history;
(2) An
assessment of the patient's current psychological and mental status;
(3) A physical examination, including
examination for:
1. Pulmonary, liver, or
cardiac abnormalities;
2.
Infectious disease; and
3.
Dermatologic sequela of addiction;
(4) Laboratory tests, including:
1. Serological test for syphilis; and
2. Urine screening for
drugs;
(5) An intradermal
PPD (tuberculosis skin test) and review of tetanus immunization status;
and
(6) When indicated, an EKG,
chest X-ray, pap smear, pregnancy test, sickle cell screening, complete blood
count and white cell differential, multiphasic chemistry profile, routine and
microscopic urinalysis, or other tests indicated by the patient's condition.
(6)
Treatment plans. Based upon the initial assessment, an
individualized written treatment plan shall be developed and recorded in the
patient's case record.
a. A treatment plan
shall be developed and shall delineate the patient's immediate needs and the
actions required to meet these needs.
b. The treatment plan shall be developed as
soon after the patient's admission as is clinically feasible, but no later than
30 days following the patient's admission to an outpatient opioid maintenance
treatment program.
c. Treatment
plans shall be developed in partnership with the patient. Comprehensive
treatment plans shall be reviewed by the primary counselor and the patient as
often as necessary, but no less than every 90 days during the first year and
semiannually each subsequent year for opioid treatment modalities. Treatment
plans shall be reviewed by the program physician on an annual basis.
(7)
Rehabilitative
services. The program shall have policies and procedures on the
minimum attendance for rehabilitative services relative to the patient's
progress and length of involvement in treatment. The minimum frequency of
rehabilitative services shall occur at the same frequency as that of on-site
dosing for patients receiving more than two take-home dosages a week in the
first year. The minimum frequency for rehabilitative services for patients
receiving two or fewer take-home dosages shall be weekly. The program shall
provide rehabilitative services that are appropriate for the patient based on
needs identified during the assessment process. A patient who does not comply
with the program's rehabilitative service requirements shall be placed on a
period of probation as defined by the program or shall be required to
immediately increase the frequency of clinic attendance for medication and
rehabilitative services. If, during a period of probation, the patient
continues to be in noncompliance with rehabilitation services, the program
shall continue to increase the attendance requirement until daily attendance is
obtained or until the patient complies with rehabilitative services. This
requirement shall not preclude the program's ability to determine that
discharge of a patient is warranted for therapeutic reasons or program
needs.
(8)
Medication
administration.
a. The program
physician shall determine the patient's initial and subsequent dose of
medication and on-site dosing schedule and shall assume responsibility for the
amount of the narcotic drug administered or dispensed and shall record, date,
and sign in each patient's case record each change in the dosage schedule. The
physician shall directly communicate orders to the pharmacy or registered or
licensed personnel supervising medication administration. The program physician
may communicate such orders verbally; however, orders shall be reduced to
writing and countersigned within 72 hours by the program physician.
b. The initial dose of medication shall not
exceed 30 milligrams, and the total dose for the first day shall not exceed 40
milligrams, unless the program physician documents in the patient's case record
that 40 milligrams did not suppress opiate abstinence symptoms. A patient
transferring into the program or on a guest-dosing status may receive an
initial dosage of no more than the last daily dosage authorized by the former
or primary program.
(1) Medication shall be
administered by a professional authorized by law.
(2) No medication shall be administered until
the patient has completed admission procedures unless the patient enters the
program on a weekend and the central registry cannot be contacted. If, in the
clinical judgment of the program physician, a patient is experiencing an
emergency situation, the admission procedures may be completed on the following
workday.
c.
Administration.
(1) Take-home medication
shall be labeled in accordance with state and federal law and have childproof
caps.
(2) A medication
administration log shall be kept in the dosing area and in the patient's case
record. The amount of medication administered and the signature of the staff
member authorized to administer the medication shall also be included in the
patient's case record. No dose shall be administered until the patient has been
positively identified and the dosage amount has been compared with the
currently ordered and documented dosage level.
(3) Ingestion shall be observed and verified
by the staff person authorized to administer the medication.
(4) The program physician shall record, date,
and sign in each patient's case record each change in the dosage schedule.
Daily dosages of medications in excess of 100 milligrams shall be dispensed
only with the approval of the program physician and shall be documented and
justified in the patient's case record.
(9)
Take-home or unsupervised
medication use.
a. Take-home
medication may be given to patients who demonstrate a need for a more flexible
schedule in order to enhance and continue rehabilitative progress. For patients
receiving take-home medication, the program shall document the following
requirements:
(1) Absence of recent abuse of
drugs (narcotic or nonnarcotic), including alcohol;
(2) Regular attendance at the
clinic;
(3) Attendance at a
licensed or approved treatment program for rehabilitative services (e.g.,
programs are considered approved when licensed or approved in accordance with
Iowa Code chapter 125);
(4) Absence
of recent criminal activity;
(5)
Stable home environment and social relationships;
(6) Active employment or participation in
school or similar responsible activities related to employment, education or
vocation; and
(7) Assurance that
medication can be safely transported and stored by the patient for the
patient's own use.
b.
Prior to granting take-home privileges, the program physician shall document in
the patient's case record that all the above criteria have been considered and
that, in the physician's professional judgment, the risk of diversion or abuse
is outweighed by the rehabilitative benefits to be derived.
c. If the patient meets the above criteria,
the patient may receive take-home medication according to the following
guidelines:
(1) During the first 90 days of
treatment, the take-home supply is limited to a single dose each
week;
(2) During the second 90 days
of treatment, the take-home supply is limited to two doses per week;
(3) During the third 90 days of treatment,
the take-home supply is limited to three doses per week;
(4) In the remaining months of the first
year, a patient may be given a maximum six-day supply of take-home
medication;
(5) After one year of
continuous treatment, a patient may be given a maximum two-week supply of
take-home medication;
(6) After two
years of continuous treatment, a patient may be given a maximum one-month
supply of take-home medication; and
(7) Take-home medication shall not be
dispensed to patients in interim maintenance treatment or
detoxification.
d. If a
patient is unable to conform to the applicable mandatory schedule, a revised
schedule may be permitted provided that the program receives an exception to
these rules from the division and SAMHSA, when applicable. A copy of the
written exception shall be placed in the patient's case record. The division
will consider exceptions only in unusual circumstances. When a program is
applying for less frequent pickups for patients, approval will be based on
considerations in addition to distance if another program exists within 25
miles of the patient's residence.
e. Should a patient receiving take-home
medication provide a drug screen that is confirmed either positive for
substances or negative for the prescribed medication, the program shall ensure
that, when test results are used, presumptive laboratory results are
distinguished from results that are definitive.
(1) The program physician shall place the
patient on three months' probation, as defined by the program, or increase the
patient's frequency of clinic dosing after considering the patient's overall
progress and length of involvement in the program.
(2) Should the patient provide a drug screen
that is positive for substances or negative for medication during a period of
probation, the program physician shall increase the patient's frequency of
clinic attendance for dosage pickup for at least three months. If after the
three-month period the patient meets the eligibility criteria, the patient may
return to the previous take-home schedule.
f. Take-home or unsupervised dosages of
medication in excess of 100 milligrams may be dispensed by the program
physician when the need for those dosages is carefully reviewed and considered
and justified in the patient's case record based on the physician's clinical
judgment.
(10)
Drug testing. Each program shall establish policies and
procedures for the collection of drug-screening specimens and utilization of
results.
a. The program shall ensure that an
initial drug-screening test or analysis is completed for each prospective
patient and that at least eight additional random tests or analyses are
performed on each patient during the patient's first year in maintenance
treatment and that at least quarterly random tests or analyses are performed on
each patient in maintenance treatment for each subsequent year. When a sample
is collected from each patient for such a test or analysis, it shall be done in
a manner that minimizes opportunity for falsification. Each test or analysis
shall be analyzed for opiates, methadone, amphetamines, cocaine, and
barbiturates. In addition, if any other drug or drugs have been determined by a
program to be abused in that program's locality, or as otherwise indicated,
each test or analysis must be analyzed for any of those drugs as well. Any
laboratory that performs the testing required under this rule shall be in
compliance with all applicable federal proficiency testing and licensing
standards and all applicable state standards.
b. The program shall ensure that test results
are not used as the sole criterion to force a patient out of treatment but are
used as a guide to change treatment approaches. The program shall also ensure
that when test results are used, presumptive laboratory results are
distinguished from results that are definitive.
(11)
Diversion prevention
plan.
a. The program shall develop a
diversion identification and prevention plan that:
(1) Outlines the methods by which the program
shall detect possible diversion of take-home medication; and
(2) Describes the actions to be taken when
diversion is identified or suspected.
b. The program shall establish and implement
proactive procedures to reduce the likelihood or possibility of diversion.
(12)
Interim
maintenance treatment.
a. An
approved program may offer interim maintenance treatment when, due to capacity,
the program cannot place the patient in a program offering comprehensive
services within 14 days of the patient's application for admission.
b. An approved program may provide interim
maintenance treatment only if the program also provides comprehensive
maintenance treatment to which interim maintenance treatment patients may be
transferred.
c. Interim maintenance
treatment program approval.
(1) Before a
public or nonprofit private narcotic treatment program may provide interim
maintenance treatment:
1. The program must
receive approval of both the U.S. Food and Drug Administration and the division
of behavioral health; and
2. The
program director must certify that the program seeking such authorization is
unable to place patients in a public or private nonprofit program within a
reasonable geographic area within 14 days of the patient's application for
admission and that interim maintenance treatment will not reduce the capacity
of the program's comprehensive maintenance treatment.
(2) Patients admitted to interim maintenance
treatment shall be transferred to comprehensive maintenance treatment within
120 days of admission.
d. Minimum standards for interim maintenance
treatment. The program may admit a patient who is eligible for comprehensive
maintenance treatment to interim maintenance treatment if the patient cannot be
placed in a public or private nonprofit comprehensive program within a
reasonable geographic area and within 14 days of application for services. An
initial drug screen and at least two other drug screens shall be taken from the
patient during the maximum admission period of 120 days. A program shall
establish and follow reasonable criteria for determining the transfer of
patients to comprehensive maintenance treatment. These transfer criteria shall
be in writing and available for inspection and shall include at a minimum a
preference for the transfer of pregnant patients. Interim maintenance shall be
conducted in accordance with all applicable federal regulations and state
rules. The program shall notify the division when a patient begins interim
treatment, when a patient leaves interim treatment, and when a patient
transfers to comprehensive maintenance treatment. Such notifications shall be
documented by the program in the patient's case record. All requirements for
comprehensive maintenance treatment apply to interim maintenance treatment,
with the following exceptions:
(1) The
medication is required to be administered daily under observation;
(2) Take-home medication is not
allowed;
(3) Initial and
comprehensive treatment plans are not required;
(4) A primary counselor is not required to be
assigned to the patient; and
(5)
Interim maintenance treatment cannot be provided for longer than 120 days in
any 12-month period.
(13)
Accreditation. All
opioid treatment programs shall obtain and retain accreditation by a recognized
national accreditation organization. The national accreditation bodies
currently recognized as meeting committee criteria are:
a. The Joint Commission.
b. The Council on Accreditation of
Rehabilitation Facilities (CARF).
c. The Council on Accreditation of Children
and Family Services (COA).
d. The
American Osteopathic Association (AOA).
