14- 118 C.M.R. ch. 5, § 2 - LICENSING PROCEDURE AND REVIEW

2.1 Terms and Types of Licenses/Certificates. Any individual(s), partnership, corporation, association, or organization desiring to operate a substance abuse program shall, prior to operations, obtain a license/certificate from the Office of Substance Abuse, except residential programs operated by hospitals that are currently accredited by the Joint Commission on Accreditation of Healthcare. They will be deemed to have met all the licensure requirements of these regulations. Application for licensure shall be made on forms provided, upon request from the Office. It is expected that the process leading to issuance or denial of a license/certificate will be completed within 90 days of receipt of the completed application packet.

2.1.1 Prohibition. No service governed by these rules may be provided without appropriate licensure/certification.

2.1.2 Licenses/certificates. Licenses/certificates shall not be issued without the identification of at least one component, one module, and one substance abuse treatment service. Licenses/certificates shall be issued to agencies that meet the following terms and conditions.

2.2 Provisional License/Certificate.

2.2.1 A provisional license/certificate shall be issued to an applicant that:

2.2.1.1 is not currently providing any service governed by these rules or has not operated during the term of that license/certificate, and

2.2.1.2 complies with these regulations, except those which can only be complied with once clients are served by the applicant; and

2.2.1.3 demonstrates the ability to comply with these regulations by the end of the provisional term. The provisional license/certificate shall specify what regulations need to be met before the program will be eligible for a full license/certificate.

2.2.2 The provisional license/certificate shall be issued for a minimum period of 3 months or a longer period, as determined appropriate by the Licensing Authority. A provisional license/certificate may be extended by the Licensing Authority but may not exceed 12 consecutive months in total length.

2.3 Full License/Certificate.

2.3.1 A full license/certificate shall be issued to an applicant that complies with all applicable laws and rules.

2.3.2 A full agency license/certificate shall be valid from the date of issuance unless revoked, suspended or made conditional.

2.4 Conditional License/Certificate.

2.4.1 A conditional license/certificate may be issued when the agency fails to comply with applicable law and rules, and, in the judgment of the Licensing Authority, the best interest of the public would be served by issuing a conditional license/certificate.

2.4.2 The conditional license/certificate shall specify when and what corrections must be made during the term of the conditional license/certificate.

2.4.3 The conditional license/certificate shall extend to cover all services provided under the license/certificate.

2.4.4 The conditional license/certificate shall be issued for a specific period not to exceed one year, or the remaining term of the previous full or provisional license/certificate, whichever the Licensing Authority determines appropriate based on the laws and rules violated. It may be extended by the Licensing Authority but may not exceed 12 consecutive months in total length.

2.5 Components, Modules, Services, and Sites

2.5.1 Agencies shall operate under one license/certificate. Only the components, modules and substance abuse treatment services specifically approved by the Licensing Authority may be provided and only at sites specifically approved for those services. An additional component, module, substance abuse treatment service, or site may be added to an existing agency license/certificate after submission and approval of a new application with the required policy and procedures, a fire inspection request form, and when an applicant:

2.5.1.1 is not currently licensed/certified to provide the service(s) for which application is made;

2.5.1.2 complies with all applicable laws and rules;

2.5.1.3 is in full compliance with other currently licensed/certified services;

2.5.1.4 does not currently have a conditional, revoked, or suspended license/certificate.

2.5.2 Substance abuse treatment programs may be eligible to provide evaluation and counseling services to clients referred from the Driver Education Evaluation Programs (DEEP). To provide DEEP services, programs must:

2.5.2.1 Comply with a signed LETTER OF AGREEMENT between the department and treatment program: and

2.5.2.2 Attend a mandatory introductory training prior to providing services for DEEP referrals and DEEP specific trainings as required by DEEP and able to show documentation of this to the Licensing Authority.

2.5.3 Substance abuse treatment programs may be eligible to provide Differential Substance Abuse Treatment (DSAT) services to clients mandated to treatment and/or referred from the criminal justice or child protection services system. To provide DSAT services programs must:

2.5.3.1 Attend mandatory trainings prior to providing DSAT services, and support DSAT trained staff in obtaining DSAT facilitator certification as required by OSA, and be able to provide documentation of facilitator training and certification or progress toward certification to the Licensing Authority, or

2.5.3.2 Be certified by OSA as a DSAT Agency and comply with the OSA DSAT Agency Certification Requirements.

2.6 Initial Application for an Agency License/Certificate.

2.6.1 Application Form. Initial applications shall be made on a form provided by the Licensing Authority.

2.6.1.1 The initial application for an initial agency license/certificate shall be signed and dated by the presiding officer of the Governing Body.

2.6.1.2 The initial application for an additional component, module, substance abuse treatment service, or site shall be signed and dated by the Chief Administrative Officer. A new application form must be submitted for any new components, modules, substance abuse treatment services, or sites requested.

2.6.1.2.1 Each application to add a component shall indicate the modules under the component for which application is made.

2.6.1.2.2 Within each module for which application is made, the specific services shall be identified.

2.6.1.2.3 The specific site from which each and every service is to be provided must be identified.

2.6.1.3 The initial application for a license/certificate shall be accompanied by documents demonstrating compliance with the licensing rules specific to the service for which application is made, and includes an Assurance of Compliance form for Title VI of the Civil Rights Act of 1964 ( 42 USC §2000d, et seq.).

2.6.1.4 The initial applications to provide any service shall be accompanied by a fire marshal request for each site, including directions to the site.

2.6.1.4.1 Any application for a residential service shall also include a floor plan sketch of the proposed service site, with room dimensions clearly noted.

2.6.1.5 Prior to the acceptance of an initial application for an Opioid Treatment program, the Office of Substance Abuse shall issue to the Licensing Authority an evaluation of the need for opioid treatment at that particular location.

2.6.1.6 Public notice and a public forum must be conducted by the applicant for all Opioid Treatment Programs, and documentation must be submitted with the application. See Title 22 M.R.S.A. Chapter 103-A.

2.6.2 Mid-Cycle Applications. Agencies seeking to add components, modules, substance abuse treatment services, or sites to existing licenses/certificates between periods of review, shall submit an initial application as described in this Section. The Licensing Authority shall review the new components, modules, substance abuse treatment services, and site(s). When approved, a license/certificate indicating the additional component, module, substance abuse treatment services, and site(s) will be issued. The term of the license/certificate shall remain unchanged.

2.6.3 Fees. Any application shall be accompanied by the appropriate fee(s), including mid-cycle applications for additional components, modules, substance abuse treatment services, and site(s).

2.6.4 Fire and Safety Inspections. Upon receipt of the completed application, the Licensing Authority shall require inspections of the physical plant(s) to ensure compliance with appropriate state and local regulations regarding fire and safety.

2.6.4.1 For nonresidential sites, fire and safety inspections conducted by authorized representatives of organized fire departments and code enforcement officers in the municipality in which the applicant service will be provided may be accepted by the Licensing Authority in lieu of inspection by the State Fire Marshall's office. The agency must indicate their intention to exercise this option in the application package. The agency is solely responsible for requesting this inspection and submitting proof of compliance in a timely way.

2.6.4.2 Residential sites must be inspected by a representative of the State Fire Marshall's office. The Licensing Authority will request the inspection.

2.6.4.3 The Licensing Authority shall not issue the license /certificate until appropriately notified of results of inspections, and plans of correction, if necessary, have been submitted and accepted.

2.6.5 Site Visits. A site visit of each service location shall be conducted by representatives of the Licensing Authority before a license/certificate is issued. The site will be evaluated for its appropriateness to provide the services planned.

2.6.6 Waivers. Waivers may be granted under the following terms and conditions:

2.6.6.1 All requests for waivers shall be made at the time of initial or renewal application. Requests shall be made in writing and submitted to the Licensing Authority.

2.6.6.2 Requests for waivers shall be accompanied by documentation that demonstrates that the terms of the waiver will comply with the intent of the rule. At the request of the Licensing Authority, expert opinion shall be provided.

2.6.6.3 Waivers granted shall be for a specific period not to exceed the term of the license/certificate. In order for an agency to renew a waiver, the agency must submit a renewal request to the-department prior to the expiration of the term of the existing license/certificate.

2.6.6.4 Violation of the waiver shall be enforceable as rule and subject to actions described in Section 2.10 regarding Sanctions and Corrective Actions.

2.6.6.5 The department may waive or modify any provision(s) of these regulations as long as the provision is not mandated by state or federal law and does not violate client rights as detailed in Section 18 of these regulations.

2.6.7 Technical Assistance. Technical assistance may be provided by the Licensing Authority to the applicant/licensee, at the request of the applicant/licensee. Technical assistance is not to be misconstrued as legal advice, and shall not be substituted for agencies' advice of counsel.

2.7 Renewal Applications.

2.7.1 General. Agencies seeking to add components, modules, substance abuse treatment services, or sites to existing licenses/certificates at the time of renewal shall submit a renewal application, as described in this section, and include the additional component, module, substance abuse treatment services, or sites for which they are seeking approval. Renewal applications may be made not less than 60 days nor more than 120 days prior to the date of expiration of the current agency license/certificate.

2.7.2 Responsibility of Licensee. The Licensee shall be solely responsible for making timely and complete application for the renewal of licenses/certificates. Failure to do so may result in the refusal to renew the licenses/certificates.

2.7.3 Renewal Application form. Renewal applications shall be made on a form provided by the Licensing Authority.

2.7.3.1 The applications shall be signed and dated by the Chief Administrative Officer.

2.7.3.2 The renewal application shall be accompanied by documentation relevant to the provision of services. This documentation must be submitted with the renewal application, whether or not previously submitted. Such documentation shall include, but is not limited to:

2.7.3.2.1 additional policies or other similar material;

2.7.3.2.2 a description of any policies or similar material that has been discontinued or suspended;

2.7.3.2.3 any client record forms that have changes;

2.7.3.2.4 new staff roster.

2.7.3.3 The renewal application shall be accompanied by a copy of documentation of audit completion, including information that the audit was done according to GAAP principles, and a report summary. (See Section 4.3 )

2.7.3.4 Requests for waivers. Requests for waivers of a particular rule or the renewal of a waiver granted under a current license/certificate shall accompany the renewal application.

2.7.3.5 Requests for deemed status Requests for deemed status, whether currently in force or newly requested, shall accompany the renewal application. The accrediting survey and findings must be included, if not previously submitted.

2.7.3.6 Renewal applications for a full license/certificate following the issuance of a conditional or provisional license/certificate shall be considered for renewal only after review by the Licensing Authority, as there is no extension beyond a year for either a conditional or provisional license/certificate.

2.7.3.7 The renewal application shall be accompanied by the appropriate fee(s). When timely applications for license/certificate renewals are made on full licenses/certificates, the existing license/certificate shall remain in effect until the Licensing Authority takes final action on such applications. The Licensing Authority shall notify the agency in writing of the receipt of its application, within 20 working days of receipt.

2.7.4 Deemed status.

2.7.4.1 Upon request by the provider, DLRS will determine whether compliance with some or all of these licensing rules is deemed based on a review of findings of an accepted accreditation body.

2.7.4.1.1 The Licensing Authority may grant deemed status, based on substantial compliance with an accreditation body's requirements, and other relevant facts.

2.7.4.1.2 A provider must be in compliance with licensing regulations not deemed by DLRS, and the provider is subject to review by the Licensing Authority.

2.7.4.1.3 Regardless of whether deemed status has been granted for all or some of these licensing regulations, DLRS may survey for compliance at its discretion.

2.7.4.2 Renewals based on certification or accreditation shall not exceed the usual two-year term of licensure without reapplication.

2.7.4.3 Licensees are solely responsible for submitting timely documentation to the Licensing Authority to demonstrate the granting of certification or accreditation.

2.7.4.3.1 Such documentation must be submitted within five business days of the agency's receipt of the Licensee's certification or accreditation.

2.7.4.3.2 The Licensee shall submit any subsequent correspondence or documentation regarding compliance with areas cited as deficient by the accrediting body.

2.7.4.4 Re-certification or re-accreditation that is granted at the end of the first year of the two year licensure period shall not cause the license/certificate to be automatically extended for the remainder of the accreditation period.

2.7.4.5 Licensees are solely responsible for submitting documentation to demonstrate recertification or re-accreditation to the Licensing Authority within five business days of learning of such re-certification or re-accreditation.

2.7.4.6 Suspension or non-voluntary withdrawal of accreditation or certification shall immediately cause the withdrawal of deemed status. Licensees shall notify the Licensing Authority within five business days of learning of such suspension or withdrawal.

2.7.4.7 Agencies that voluntarily withdraw from accreditation or certification programs shall notify the Licensing Authority thirty (30) days before the date the withdrawal takes effect. At the discretion of the Licensing Authority, a site visit may be conducted to ensure compliance with these rules.

2.7.4.8 Agencies licensed/certified under deemed status shall be subject to review by the Licensing Authority for compliance with applicable federal and state laws and rules.

2.8 Transfer of Licenses/Certificates. No license/certificate shall be transferable from one Licensee to another, one component or module to another, one location to another or to expand services to additional locations.

2.9 Licensing Authority's Assessment of Provider Compliance.

2.9.1 Visits to Determine Compliance. Any employee authorized by the Licensing Authority shall have the right of entry at any time consistent with usual hours of operation of the agency or service, to inspect the facility. The Licensing Authority may also copy any documents and records required by these rules in order to determine compliance with law and with these rules.

2.9.1.1 The Licensing Authority shall have the ability to meet or speak with any client, in private, for the purpose of investigating a suspected violation of law or rules established by the department. The client has the right to refuse to meet or speak to the Licensing Authority.

2.9.1.2 The Licensing Authority may enter a facility that it believes is operating without a license/certificate only with the permission of the owner or person in charge or with a search warrant from the District Court authorizing entry and inspection.

2.9.2 Availability of Information. The Licensing Authority shall have access to any information which the agency is required to have under these rules and any information reasonably related to assessment of compliance with these rules.

2.9.3 Review Components. Licensing Reviews consist of, but are not limited to, reviewing Governing Body Board Minutes; Client Grievances (if applicable); contracted staff agreements (if applicable); Policies and Procedures for each program; Client Records for each program (to be selected by Licensing Authority); Staff and Client interviews for each program reviewed; Fire Drill Logs for each site; Personnel Records for staff in each program reviewed (to be selected by Licensing Authority); Supervision Logs; Annual Evaluations/Quality Assurance Plan; Staff Development Plan; Financial Audit; Professional and Commercial Insurance; Americans with Disabilities Act (ADA); Plans of Correction (if applicable); Fee Schedule; Fire Inspection/Health Inspection; and Written Agreement with Medical Director.

2.9.4 Statement of Deficiencies. After inspection, an SOD will be sent to the licensee if the inspection identifies any failure to comply with licensing regulations. The licensee shall complete a Plan of Correction (hereinafter "POC") for each deficiency, sign the plan and submit it to the department within ten (10) working days of receipt of any SOD. Failure to correct any deficiency or to file an acceptable POC with the department may lead to the imposition of sanctions or penalties as described in Sections 2.10 of these regulations.

2.10 Sanctions and Corrective Actions. Whenever the Licensing Authority finds that a service governed under these rules is being provided in a manner not in compliance with applicable rules, or an agency is operating in a manner not in compliance with these rules, the Licensing Authority may take certain actions.

2.10.1 Notice. The Licensing Authority shall notify the agency of the need for a license/certificate. If they are providing an unlicensed service and are unaware of the licensing process, they shall be informed that they have access to technical assistance. If the agency refuses to become licensed/certified, the Licensing Authority may initiate legal action, which may include the department filing a complaint with the District Court in accordance with the Maine Administrative Procedure Act, Title 5 M.R.S.A. Chapter 375.

2.10.2 Licensing Authority action. The Licensing Authority may take action against an agency's license/certificate relative to one or more components, modules, substance abuse treatment services, or sites operated under the agency's license/certificate, to include the issuance of a conditional license/certificate or other remedies as noted here. Consideration of the severity and pervasiveness of the deficiencies, the ability of the administration of the agency to have known or prevented the violations, the degree to which the agency was forthcoming or deceptive in reporting information to the Licensing Authority, and other relevant facts must be identified and outlined in a written report to the agency.

2.10.3 Refusal to Issue or Renew. When an applicant fails to comply with applicable law, rules, and professional code of ethics, the Licensing Authority may refuse to issue or renew the license/certificate, in whole or for specific components, modules, sites or substance abuse treatment services.

2.10.4 Issuance of Conditional License/Certificate. If, at the expiration of a full or provisional license/certificate or during the term of a full or provisional license/certificate the agency fails to comply with applicable law and rules and, in the judgment of the Licensing Authority, the best interest of the public would be served, the Licensing Authority may issue a conditional license/certificate or change a full license/certificate to a conditional license/certificate.

2.10.5 Voiding a Conditional License/Certificate. Failure by the conditional licensee to meet the conditions specified by the Licensing Authority shall permit the Licensing Authority to void the conditional license/certificate or refuse to issue a full license /certificate. The conditional license/certificate shall be void when the Licensing Authority has delivered in hand or by certified mail a written notice to the Licensee or, if the Licensee cannot be reached for service in hand or by certified mail, has left written notice thereof at the agency.

2.10.6 Amend or Modify a License/Certificate. The department may amend or modify a license/certificate.

2.10.7 Emergency Suspension. Whenever, upon investigation, conditions are found which, in the opinion of the department, immediately endanger the health or safety of persons living in or attending a facility, the department may request the District Court for an emergency suspension pursuant to Title 4 M.R.S.A. §184, subsection 6.

2.10.8 Suspension, Revocation: Any license/certificate issued may be suspended or revoked for violation of applicable law and rules, or for committing, permitting, aiding or abetting any illegal practices in the operation of the program, or for conduct or practices detrimental to the welfare of persons living in or attending the facility, or receiving services. When the department believes that a license/certificate should be suspended or revoked, it shall file a complaint with the District Court as provided in the Maine Administrative Procedure Act, Title 5 M.R.S.A. Chapter 375.

2.10.9 Health and Safety Hazard. Whenever, upon investigation, conditions are found which, in the opinion of the department, immediately jeopardize the health or physical safety of persons living in or attending a facility or receiving services from an agency, the department may revoke, suspend or refuse to renew any license/certificate without hearing for a period not to exceed thirty (30) days, in accordance with Title 5 M.R.S.A. §10004(3).

2.11 Appeals. Once the department determines, in a non emergency situation, that an agency is not in compliance with a regulation and has determined that a negative licensing action shall be taken, the agency may avail itself of the following:

2.11.1 Statement of Deficiencies and Negative Licensing Action Determination. Statement of Deficiencies that result in a negative licensing action determination by the department may be appealed. Statement of Deficiencies that do not result in a negative licensing action determination by the department cannot be appealed.

2.11.2 Request for Administrative Hearing. Within 10 days of receipt of the notice of the department's determination that a negative licensing action shall be taken, the agency may file a written request with the department for an administrative hearing. If the request for hearing is received within this period, the proposed action will not take effect until after the Commissioner's Final Decision.

2.11.3 Failure to Request a Hearing. In the event the agency fails to request a hearing within I0 days of the notice of action, the action will take effect at the expiration of the 10 day period.

2.11.4 Appeal Procedures. An agency aggrieved by a hearing decision issued as a result of the department's administrative hearing, may file, within 30 days of the notice of the decision, a complaint with the Superior Court as provided in 5 M.R.S.A. §11002.

Notes

14- 118 C.M.R. ch. 5, § 2