DHS 75.59(23)(a)(a) Service sponsor. A person who sponsors an OTP and any personnel responsible for a particular service shall agree in writing to adhere to all applicable requirements of this chapter and 21 CFR part 291 and 42 CFR part 2. DHS 75.59(23)(b)(b) Responsibilities. The service sponsor is responsible for all service staff and for all other service providers who work in the service at the primary facility or at other facilities or medication units. DHS 75.59(23)(c)(c) Written agreement. The service sponsor shall agree in writing to inform all service staff and all contracted service providers of the provisions of all pertinent state rules and federal regulations and shall monitor their activities to ensure that they comply with those rules and regulations. DHS 75.59(23)(d)(d) Replacement. The service shall notify the designated federal agency and SOTA within 5 business days after replacement of the service sponsor or medical director. DHS 75.59(23)(e)(e) Required services. OTPs shall provide adequate medical, counseling, vocational, educational, and other assessment and treatment services. These services must be available at the primary facility, except where the program sponsor has entered into a formal, documented agreement with a private or public agency, organization, practitioner, or institution to provide these services to patients enrolled in the OTP. The program sponsor, in any event, must be able to document that these services are fully and reasonably available to patients. This documentation must be provided to the department upon request. DHS 75.59(24)(24) Death reporting. An OTP shall report the death of a patient and deaths related to a patient’s medication to the SOTA within 5 business days after learning of the death. DHS 75.59(25)(a)(a) Policy and procedure. The service must develop and maintain a policy and procedure that requires the ongoing monitoring of the data from the prescription drug monitoring program (PDMP) for each patient. The policy and procedure must include how the service meets the requirements in par. (b). DHS 75.59(25)(b)(b) Requirements. If a medication used for the treatment of substance use disorder is administered or dispensed to a patient, the OTP shall be subject to the following requirements: DHS 75.59(25)(b)1.1. Upon admission a patient must be notified in writing that the medical director must monitor the PDMP to review the prescribed controlled drugs a client received. DHS 75.59(25)(b)2.2. The medical director or the medical director’s delegate must review the data from the PDMP before the patient is ordered any controlled substance including medications for maintenance therapy, and subsequent reviews of the PDMP data must occur at least every 90 days. DHS 75.59(25)(b)3.3. A copy of the PDMP data reviewed must be maintained in the client’s file. DHS 75.59(25)(b)4.4. When the PDMP data contains a recent history of multiple prescribers or multiple prescriptions for controlled substances, the physician’s review of the data and subsequent actions must be documented in the patient’s file within 72 hours and must contain the medical director’s determination of whether the prescriptions place the patient at risk of harm and the actions to be taken in response to the PDMP findings. The provider must conduct subsequent reviews of the PDMP in these circumstances on a monthly basis. DHS 75.59(25)(b)5.5. If at any time the medical director believes the use of the controlled substances places the patient at risk of harm, the service must seek the patient’s consent to discuss the patient’s opioid treatment with other prescribers and for other prescribers to disclose to the OTP’s medical director of the client’s condition that formed the basis of the other prescriptions. If the information is not obtained within 7 days, the medical director must document whether or not changes to the client’s medication dose or number of unsupervised use doses are necessary until the information is obtained. DHS 75.59(25m)(a)(a) Approval. To receive a guest dose, the patient must be enrolled in an OTP elsewhere in the state or country and be receiving the medication on a temporary basis because the client is not able to receive the medication at the program in which the client is enrolled. A patient may guest dose at a different OTP if prior approval is obtained from the patient’s medical director or program physician to receive services on a temporary basis from another OTP certified under this rule or by SAMHSA. The approval shall be noted in the patient’s record and shall include the following documentation: DHS 75.59(25m)(a)1.1. The patient’s signed and dated consent for disclosing identifying information to the program which will provide services on a temporary basis. DHS 75.59(25m)(a)2.2. A medication change order by the referring medical director or program physician permitting the patient to receive services on a temporary basis from the other program for a length of time not to exceed 30 days. DHS 75.59(25m)(a)3.3. Evidence that the medical director or program physician for the program contacted to provide services on a temporary basis has accepted responsibility to treat the visiting patient, concurs with his or her dosage schedule, and supervises the administration of the medication. DHS 75.59(25m)(b)(b) Maximum number of days. Guest dosing shall be provided for a maximum of 30 days. DHS 75.59(25m)(c)(c) Patient requirement. Patients receiving guest dosing shall have been enrolled at the home clinic for a minimum of 30 days before being eligible for a guest dose. Patients enrolled less than 30 days at the home clinic shall be eligible for guest dosing only if approved by the SOTA. DHS 75.59(25m)(d)(d) Drug screen requirement. Patients shall have two consecutive urine drug screens free of illicit substances or substances of abuse before being eligible for a guest dose, unless the medical director determines that the benefits of guest dosing outweigh the risks and documents the justification for granting guest dosing privileges in the patient’s record. DHS 75.59(26)(a)(a) Naloxone. An OTP shall provide a patient with a naloxone kit or a prescription for naloxone at admission. The OTP shall provide instruction on the kits use including recognizing the signs and symptoms of overdose and calling 911 in overdose situations. DHS 75.59(26)(b)(b) Use or expiration of Naloxone. The OTP shall provide a new naloxone kit or prescription upon expiration or use of the old kit. DHS 75.59(26)(c)(c) Exemption. The OTP shall be exempt from this requirement for one year if the client refuses the naloxone kit or already has a naloxone kit. DHS 75.59(26)(d)(d) Orientation training. Documentation that the patient has completed the orientation training on recognizing an overdose and how to use naloxone and received written information shall be completed and signed by service staff and the patient and maintained in the patient’s record. DHS 75.59(27)(a)(a) The provision of interim maintenance with medication assisted treatment is prohibited under this rule unless the opioid treatment program has a waiver from the department in addition to authorization from SAMHSA in accordance with 42 CFR 8.11 (g). DHS 75.59(27)(b)(b) All of the requirements for comprehensive maintenance treatment apply to interim maintenance treatment with the following exceptions for patients receiving methadone: no take-home doses are permitted except on federal holidays if the program is closed on those days; an initial and periodic treatment plan are not required; a primary counselor is not required; and the rehabilitative and other services described in 42 CFR. 8.12 (f) (4), (f) (5) (i), and (f) (5) (iii) are not required. DHS 75.59(27)(c)(c) Interim maintenance cannot be provided to an individual for more than 120 days in any 12-month period. DHS 75.59(27)(d)(d) To receive interim maintenance, a patient must be fully eligible for admission to comprehensive maintenance. DHS 75.59(27)(e)(e) Interim maintenance treatment is for those patients who cannot be enrolled in comprehensive maintenance treatment in a reasonable geographic area within fourteen days of application for admission. DHS 75.59(27)(f)(f) During interim maintenance, the initial toxicology and at least two additional toxicology screening tests should be obtained. DHS 75.59(27)(g)(g) Programs offering interim maintenance must develop clear policies and procedures governing the admission to interim maintenance and transfer of patients to comprehensive maintenance. DHS 75.59(28)(a)(a) Emergency situations. Each OTP shall maintain an up-to-date disaster plan that addresses emergency situations including fire emergencies, tornadoes, earth quakes, flooding, winter storms, pandemics, and involuntary temporary or permanent facility closure. DHS 75.59(28)(b)(b) Committee. OTPs shall establish a health and safety committee that initiates planning actions for disaster scenarios. This committee shall: DHS 75.59(28)(b)1.1. Identify internal resources and areas of need that shall include, at minimum, considerations of: DHS 75.59(28)(b)2.2. Identify external resources and areas of need that shall include, at minimum: DHS 75.59(28)(b)3.3. Develop a communication plan for the disaster scenario to inform patients, the SOTA, SAMHSA, the DEA, and any other parties deemed necessary. DHS 75.59(28)(b)4.4. Develop disaster documentation procedures for guest patients that shall include at minimum: DHS 75.59(28)(c)(c) Emergency contact. Each OTP shall provide the SOTA with the emergency contact information for at least one member of the service. DHS 75.59(28)(d)(d) Medication supply. Each OTP shall keep at least a 10-day supply based on average caseload of methadone and buprenorphine products on site to prepare to receive clients from other facilities in disaster scenarios. DHS 75.59 HistoryHistory: CR 20-047: cr. Register October 2021 No. 790, eff. 10-1-22; correction in (5) (b), (g) , (6) (a) 3. a., 4., (h), (k) 2., (7) (a) (intro.), (9) (a), (10) (c) 12., (12) (b) 2., (d) 2., 7., (h) 1. d. to f., 2. a. to e., (15) (a) 1., (21) (e), (f), (23) (a) made under s. 35.17, Stats., correction in numbering in (25m) made under s. 13.92 (4) (b) 1., Stats., correction in (6) (i) 3. made under s. 13.92 (4) (b) 4., Stats., and (10) (b) (title) created under s. 13.92 (4) (b) 2., Stats., Register October 2021 No. 790. DHS 75.60DHS 75.60 Office-based opioid treatment. DHS 75.60(1)(1) Applicability. This section shall not apply to office-based opioid treatment occurring in any of the following settings: DHS 75.60(1)(a)(a) A treatment service in which all patients receiving medication for addiction are enrolled in a service otherwise certified under this chapter. DHS 75.60(1)(e)(e) A service providing medication for addiction to less than 30 patients. DHS 75.60(2)(2) Service description. In this section, “office-based opioid treatment,” or “OBOT” service means pharmacotherapy for opioid use disorder, delivered in a stand-alone office-based opioid treatment clinic, a private office, or public sector clinic setting, excluding certified settings exempted in s. DHS 75.60 (1) or otherwise certified under this chapter, by practitioners authorized to prescribe outpatient supplies of medications approved by the FDA for the treatment of opioid addiction or dependence, prevention of relapse of opioid addiction or dependence, or both. An OBOT is subject to the oversight of the state opioid treatment authority. OBOT includes treatment with all medications approved by the FDA for such treatment. DHS 75.60(3)(3) Relationship to treatment service general requirements. A service that provides OBOT under this section shall be exempt from the treatment service general requirements in subchapter IV, unless otherwise indicated in this section. DHS 75.60(4)(a)(a) “Drug Addiction Treatment Act of 2000” (DATA 2000) means Title XXXV, Section 3502 of the Children’s Health Act, permits physicians who meet certain qualifications to treat opioid addiction with Schedule III, IV, and V narcotic medications that have been specifically approved by the FDA for that indication. DHS 75.60(4)(b)(b) “DATA 2000 waiver” means an authorization conveyed by SAMHSA and the DEA to a practitioner that permits them to prescribe or administer buprenorphine products to an individual with an opioid use disorder. DHS 75.60(4)(c)(c) “Primary care service” means outpatient general health care services provided by a clinic for regular health care services, preventive care, or for a specific health concern, and includes all of the following: DHS 75.60(4)(c)1.1. Care that promotes and maintains mental and physical health and wellness. DHS 75.60(4)(c)3.3. Screening, diagnosing, and treating acute or chronic conditions caused by disease, injury, or illness. DHS 75.60(4)(c)5.5. Provision of a broad spectrum of preventive and curative health care over a period of time. DHS 75.60(5)(5) State opioid treatment authority. The powers and duties of the SOTA include: DHS 75.60(5)(a)(a) Facilitating the development and implementation of rules, regulations, standards, and evidence-based practices, emerging best practices, or promising practices, to ensure the quality of services delivered by OBOT services. DHS 75.60(5)(b)(b) Acting as a liaison between relevant state and federal agencies. DHS 75.60(5)(c)(c) Reviewing opioid treatment guidelines and regulations developed by the federal government. DHS 75.60(5)(d)(d) Delivering technical assistance and informational materials to OBOT services as needed. DHS 75.60(5)(e)(e) Performing both scheduled and unscheduled site visits OBOTs in cooperation with department certification office or other oversight agencies, or as designated by the SOTA, when necessary and appropriate, and preparing reports as appropriate. DHS 75.60(5)(f)(f) Consulting with the federal government regarding approval or disapproval of requests for exceptions to federal regulations, where appropriate. DHS 75.60(5)(g)(g) Receiving and addressing service recipient appeals and grievances in partnership with the department’s client rights office. DHS 75.60(5)(h)(h) Issuing a list of required evidence-based practices, emerging best practices, and promising practices to be delivered by OBOT services, so long as the required practices are recognized by SAMHSA, Centers for Disease Control, or National Institute of Health. The SOTA may also provide a list of recommended evidence-based practices, emerging best practices, and promising practices. The SOTA may update the required practices list and the recommended practices list as needed to reflect advances in outcomes research and medical services for persons living with opioid use disorders. The SOTA shall take into consideration the adequacy of evidence to support the efficacy of the practice, the quality of workforce available, and the current availability of the practice in the state when updating the lists. At least 120 days before issuing the initial required practices list and any revisions to the required practices list, the SOTA shall provide stakeholders with an opportunity to comment and shall take those comments into consideration when updating the required practices list. DHS 75.60(6)(a)(a) Governing authority or entity owner. The governing authority or entity owner of an OBOT service shall do all of the following: DHS 75.60(6)(a)1.1. Designate a member or representative of the governing body that is legally responsible for the operation of a service that has the authority to conduct the policy, actions, and affairs of the service, to complete the entity owner background check and to be the entity owner responsible for a service. DHS 75.60(6)(a)2.2. Appoint a service director whose qualifications, authority, and duties are defined in writing.
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