Current through Register Vol. 46, No. 39, September 25, 2024
(a) General requirements for all patient
records. All programs must maintain a patient record (either electronic or
paper) for each patient who receives services. The patient record must
demonstrate a chronological pattern of delivered medical and treatment services
consistent with the patient's prior treatment history, if any, and the
patient's evolving treatment/recovery plan, updated regularly through progress
notes. The patient record shall also include:
(1) the source of referral, if applicable;
(2) a notation that, prior to the first
treatment visit, the patient received a copy of the program's rules and
regulations, including patient's rights (Part 815) and a summary of the federal
confidentiality requirements, that such rules and regulations were discussed
with the patient, including their ability to designate individuals to be
notified in case of an emergency and that the patient indicated he/she
understood them;
(3) any clinical
or non-clinical documentation or determination applicable to the delivery of
medical and treatment services for a patient and/or supporting the patient's
evolving treatment/recovery plan;
(4) the individual treatment/recovery plan and all reviews and
updates thereto through progress notes;
(5) signed releases of consent for information;
(6) documentation of services in accordance
with this Part;
(7) documentation
of level of care determinations using the OASAS level of care protocol for
admission and level of care transition;
(8) transition planning, including medication list,
circumstances/reason, and referrals made;
(9) if the patient is a minor being treated without parental
consent, documentation establishing that the provisions of Mental Hygiene Law
section 22.11 have been met.
(10)
information and documentation required in screening and admission;
(11) all lab results;
(12) current approved medication doses and
justification for any changes; and
(13) include an order sheet that is displayed in the patient
record and signed (physical or electronic signature) by any medical
professional licensed under the appropriate state law authorizing such change
and noting the date for each approved medication order and dose
change.
(b) Admission
requirements applicable to all programs:
(1)
Diagnosis.
(i) Unless otherwise authorized,
the program must document that the individual is determined to have a substance
use disorder based on the criteria in the most recent version of the Diagnostic
and Statistical Manual (DSM) or the International Classification of Diseases
(ICD).
(ii) For a significant
other, the program must document that the individual is determined to have a
diagnosis consistent with the presenting concerns related to a close
relationship with someone who has a substance use disorder.
(2) If an individual has been referred by an
Office approved Driving While Intoxicated (DWI) provider/practitioner, any
assessment created by such provider which meets the requirements of this
section may be used to admit the patient.
(3) Documentation of admission must:
(i) include the level of care determination;
(ii) include an assessment, initial services
and diagnosis that form the basis of the treatment/recovery plan;
(iii) be made by a clinical staff member who
is a qualified health professional and must be documented by the dated
signature (physical or electronic) of the qualified health professional working
within their scope of practice and include the basis for admitting the patient;
and
(iv) be approved by the dated
signature (physical electronic) of a physician, physician's assistant, nurse
practitioner, licensed psychologist, or licensed clinical social
worker.
(4) Patients
being admitted to an OTP must be documented to have a minimum 12-month opioid
use disorder (OUD) accompanied by a physical evaluation. A comprehensive
physical examination must be completed within fourteen days, or otherwise in
accordance with federal rules.
(5)
If the presenting individual is determined to be inappropriate for admission to
the program, a referral and connection to a more appropriate service must be
made, unless the individual is already receiving substance use disorder
services from another provider. Individuals deemed ineligible for admission
must be informed of the reason.
(6)
No individual that meets level of care criteria may be denied admission to a
program consistent with the provisions of Part 815 of this Title.
(7) All prospective patients must be
informed that admission to a program is on a voluntary basis and a prospective
patient is free to discharge themselves from the service at any time. For
prospective patients under an external mandate, the potential consequences for
premature discharge must be explained, including that the external mandate does
not alter the voluntary nature of admission, continued treatment, and
toxicology screening.
(8) A
significant other may be admitted to a program regardless of whether the
individual with whom they are associated is in treatment. A significant other
is not appropriate for admission to an outpatient rehabilitation
service.
(c)
Post-admission.
(1) As soon as possible after
admission, if not already complete, every patient must be:
(i) offered viral hepatitis testing; testing
may be done on site or by referral;
(ii) offered HIV testing; testing must be conducted with patient
consent in accordance with public health law and may be done on site or by
referral; individuals on a regimen of pre- or post-exposure prophylaxis, must
be permitted to continue the regimen until consultation with the prescribing
professional occurs;
(iii)
screened for co-occurring mental health conditions and behavioral health risk
including suicide risk using validated screening instruments approved by the
Office.
(2) If
clinically indicated, all programs must:
(i)
conduct an intradermal skin or blood-based Tuberculosis test; testing may be
done on site or by referral with results as soon as possible after testing; for
patients with a positive test result, refer the patient for further
tuberculosis evaluation.
(ii)
offer testing for other sexually transmitted infections; testing may be done on
site or by referral;
(iii) provide
or recommend any other tests the examining physician or other medical staff
member deems to be necessary including, but not limited to, an EKG, a chest
X-ray, or a pregnancy test.
(3) As soon as possible after testing programs must explain or
ensure that the provider has explained, any blood and skin test results to the
patient.
(4) For those patients
who have not had a physical examination within one year prior to admission,
each such patient must either be assessed by a member of the medical staff to
ascertain the need for a physical examination or referred for a physical
examination. For those patients who have had a physical examination within one
year prior to admission, or for those patients being admitted directly to the
outpatient program from another substance use disorder service authorized by
the Office, the existing medical history and physical examination documentation
may be used to comply with the requirements of this subdivision, provided such
documentation has been reviewed by a medical staff member and determined to be
current. Notwithstanding the foregoing, HIV and viral hepatitis testing shall
be offered regardless of a documented history within the previous twelve
months. OTPs are exempt from this requirement but must provide physical
examinations in accordance with federal rules.
(d) Additional admission requirements for
outpatient rehabilitation services. In addition to the requirements of
paragraph (a) of this section, an individual must also meet the criteria in
Section 822.10 of this Part to be admitted to an outpatient rehabilitation
service.
(e) Additional admission
requirements for OTPs.
(1) The decision to
admit a prospective patient for treatment is finalized on the date of
administration or prescription of the initial approved medication dose after
satisfaction of all applicable requirements of this Part. Prospective patients
with a chronic immune deficiency or prospective patients who are pregnant and
have a current opioid or past opioid dependency must be screened and admitted
on a priority basis. No person under the age of 16 may be admitted without the
prior approval of the Office. The following requirements must be met for an
individual to be admitted:
(2) In
order to administer the first medication dose, a patient must have an in-person
evaluation, including a physical evaluation, to determine that they have had a
physiological dependence on opioids for at least the previous 12-month period,
and must diagnose and document such, provided however:
(i) a prospective patient may be admitted who voluntarily
completed treatment in another program without confirming current opioid
dependence if the program confirms that the:
(a) voluntary completion of treatment occurred within the previous
24 months; and
(b) previous
treatment lasted at least 6 months;
(ii) a prospective patient who is less than 18 years of age may be
admitted if such patient has had at least two prior treatment episodes within a
12-month period and a dependence on opioids;
(iii) a prospective patient who resided in a correctional or
chronic care facility for at least one month, if assessed within 6 months after
release or discharge, may be admitted if the prospective patient would have
been eligible for admission prior to residing in such
facility.
(3) A
physician, or other practitioner with federal approval, must ensure that prior
to first dose, the prospective patient is provided and signs (physical or
electronic signature) an informed written consent to participate in an opioid
treatment program, which shall include notice of the risks and benefits of a
prescribed medicine.
(4) Each OTP
must issue a photo-identification card to each patient within two weeks after
admission; patients may carry the identification or, at the patient's option,
have the identification maintained at the program.
(f) Readmissions to OTPs. Programs need not
repeat admission procedures for any patient who is being re-admitted within
three (3) months of discharge and need not repeat a medical and laboratory
examination if the patient received a medical and laboratory exam within the
previous year, provided:
(1) The patient's
prior medical records must be combined with the new medical records within
thirty days of the patient's readmission;
(2) each program must immediately readmit patients who were
previously discharged from that program:
(i)
after a stay of 30 days or more in a hospital, nursing home, or other health
care facility, if such patient is still being maintained on an approved
medication, and/or meets the eligibility requirements when released;
or
(ii) after an extended
incarceration (including KEEP), if clinically appropriate when such patient is
released.
(g)
Transfers between OTPs.
(1) Each program must
develop procedures regarding the transfer of patients which must ensure that
the program shall:
(i) not deny a reasonable
request for a temporary or permanent transfer;
(ii) not include "temporary-to-permanent" conditions, whereby a
patient is temporarily provided guest medication and then evaluated as to
whether or not the OTP will permanently admit, unless otherwise authorized by
the Office;
(iii) regard transferred
patients as continuing in treatment by incorporating their length of treatment
and treatment/recovery plans from the referring program;
(iv) send or receive the reason for the
transfer and provide the most current medical, counseling, and laboratory
information within fourteen (14) days of the request. Receipt of this
information is not required prior to acceptance and the failure to receive this
information will not preclude acceptance; and
(v) continue the patient's approved medication dosage and
take-home schedule unless new medical or clinical information requires medical
staff to review and subsequently order a change.
(2) Each program must develop procedures for
the temporary transfer of patients which must ensure that the:
(i) transferring programs forward
information on fees, contact person, time and dose of medication to the
receiving program;
(ii) Program
sends or receives prior to the patient's arrival the reason for the temporary
transfer including temporary dates and approved medication dose;
(iii) Program shall not deny a reasonable
request for a temporary transfer;
(iv) transferring program remains responsible for the patient's
overall treatment. The receiving program may deliver any necessary service
after consultation with the transferring program; and
(v) receiving program prescribing
professional must write an order to continue the patient's medication dose and
take-home schedule.
(h) Treatment/recovery plan.
(1)
Each patient must have a written person-centered treatment/recovery plan
developed by the clinical staff person with primary responsibility for the
patient, in collaboration with the patient and anyone identified by the patient
as supportive to recovery goals. The treatment/recovery plan begins with the
assessment incorporated into the patient record and is regularly updated with
progress notes.
(i) Minor patients: If the
patient is a minor, the treatment/recovery plan must also be developed in
consultation with the patient's parent or guardian unless the minor is being
treated without parental consent as authorized by Mental Hygiene Law section
22.11.
(ii) Immediate transfer: For
patients moving directly from one program to another, the existing
treatment/recovery plan may be used if there is documentation that it has been
reviewed and, if necessary, updated to reflect patient goals as
appropriate.
(2) The
treatment/recovery plan must:
(i) include the
assessment, which identifies each diagnosis for which the patient is being
treated;
(ii) be incorporated into
the patient record through regular progress notes, including initial services
to be offered prior to completion of the initial assessment;
(iii) address patient goals as identified
through the assessment process and regularly updated as needed through progress
notes;
(iv) identify a single
member of the clinical staff responsible for coordinating and managing the
patient's treatment who shall approve and sign (physical or electronic
signature) such plan;
(v) reference
to any significant medical and psychiatric issues, including all medications,
by acknowledging review of medical/psychiatric assessment and progress notes,
as well as coordination with mental and psychiatric providers; and
(vi) be reviewed and approved by the
clinical staff person responsible for developing the plan, the patient and the
clinical supervisor.
(i) Continuing review of treatment/recovery plans. The
treatment/recovery plan must be reviewed through the ongoing assessment process
and regular progress notes.
(j)
Progress Notes. Progress notes are intended to document the patient's clinical
status. Service delivery should be documented in the patient record through
regular progress notes that include, unless otherwise indicated, the type,
content, duration and outcome of each service delivered to or on behalf of a
patient, described and verified as follows:
(1) be written and signed (physical or electronic signature) by
the staff member providing the service;
(2) indicate the date the service was delivered;
(3) record the relationship to the patient's
developing treatment goals described in the treatment/recovery plan;
and
(4) include, as appropriate and
relevant, any recommendations, communications, or determinations for initial,
continued or revised patient goals and/or treatment.
(k) The program's multidisciplinary team, as
defined in Part 800 of this Title, shall meet on a regularly scheduled basis
for the purpose of reviewing a sample of cases for the purpose of clinical
monitoring of practice. This meeting shall be documented as to date,
attendance, cases reviewed and recommendations.
(l) Pregnancies. Treatment/recovery plans must include provisions
for pre-natal care for all patients who are pregnant or become pregnant. If a
pregnant patient refuses or fails to obtain such care, the provider must have
the patient acknowledge in writing that pre-natal care was offered,
recommended, and refused. The program should also offer to develop a plan of
safe care with the patient and anyone identified by the patient, such offer
should be noted in the patient record.
(m) Communicable disease. Treatment/recovery plans must include
provisions for the prevention, care and treatment of HIV, viral hepatitis,
tuberculosis and/or sexually transmitted infections when present. If a patient
refuses to obtain such care, the provider must have the patient acknowledge in
writing that such care was offered, recommended, and refused.
(n) Transfers. If patients are transferred
between a SUD outpatient program and outpatient rehabilitation services within
the same provider, a single patient record may be maintained provided that it
includes clinical justification for the transfer, the effective date of the
transfer and a revised treatment/recovery plan, if necessary, signed (physical
or electronic signature) by a clinical staff member and their
supervisor.
(o) Confidentiality.
Patient records maintained by the program are confidential and may only be
disclosed consistent with the Health Insurance Portability and Accountability
Act (HIPAA) and the federal regulations governing the confidentiality of
patients' records as set forth in 42 CFR Part 2 and other applicable
law.
(p) Records retention. Patient
records must be retained for ten (10) years after the date of discharge or last
contact, or three (3) years after the patient reaches the age of eighteen,
whichever time period is longer.
(q) Patient deaths. If a patient dies while in active treatment
any known details must be documented in the patient record.
(r) Transition or discharge criteria.
(1) Patients having no contact or intent to
continue accessing services from a program should be discharged after a period
not exceeding sixty (60) days unless reason for continuing treatment past that
period is identified and documented in the patient record.
(2) Individuals entering treatment should
progress by meeting treatment milestones including: stabilization; engagement;
goal setting; and attainment of patient-centered goals. Individuals should be
considered for transitions to the community or another level of care once they
have stabilized and attained the support necessary to support their goals. If
an individual leaving treatment expresses a preference for a level of care or
services that preference should be included in the patient record.
(3) Individuals who are discharged
involuntarily must be discharged consistent with Part 815 of this
Title.
(4) Transition plan.
(i) A transition plan must be developed in
collaboration with the patient and any collateral person(s) the patient chooses
to involve. Such plan shall specify needed referrals with appointment dates and
times, all known medications (including frequency and dosage) and
recommendations for continued care.
(ii) The transition plan shall include an appointment with an
appropriate provider to continue access to approved medications to treat the
patient's substance use disorder.
(iii) If the patient is a minor, the plan must also be developed
in consultation with their parent or guardian, unless the minor is being
treated without parental consent as authorized by Mental Hygiene Law section
22.11; information pertaining to the testing and treatment of sexually
transmitted infections cannot be shared with the minor patient's parent or
guardian without the patient's consent, in accordance with applicable laws and
regulations.
(5) No
patient may be discharged without a plan which has been previously reviewed and
approved by a clinical staff member and the clinical supervisor. This
requirement does not apply to patients who stop attending, or otherwise fail to
cooperate, or refuse continuing care or OBOT planning. That portion of the
transition plan which includes referrals for continuing care must be given to
the patient prior to leaving the program. The patient, and their
family/significant other(s), shall be offered overdose prevention education and
training, and a naloxone kit or prescription.
(s) Continuing Care. Individuals may be
admitted to continuing care when they require a less intensive amount of
support and services and there is a documented clinical need for ongoing
clinical support to maintain gains made in treatment.
(1) The purpose of continuing care is to provide ongoing disease
management services including management of life stressors, urges and cravings,
mood and interpersonal relationships and to maintain gains made in
treatment.
(2) Individuals in
continuing care may receive counseling or peer services, rehabilitative support
services including case management and medication management services as
needed.
(3) Patients receiving OTP
services are not appropriate for continuing care as defined
herein.