reglab/statecodes huggingface dataset:
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-10 - Facility Construction and Renovations; Life Safety Policies and Procedures

Current through Register Vol. XLI, No. 28, July 12, 2024
10.1.
				Before extensive construction or renovation of a MAT program facility begins,
				the program shall submit to the Secretary for approval a complete set of the
				plans for the project, which includes the drawings and specifications for the
				architectural, structural and mechanical design and work.
10.2. The Secretary shall advise the program
				within 60 days whether approval has been granted. In the event the plans for
				the project are not approved, the Secretary shall set forth in writing the
				reasons for the disapproval and provide the program the opportunity to correct
				any deficiencies. Extensive construction or renovation of a facility may not
				begin until the Secretary has issued final approved of the plans.
10.3. All MAT program facilities shall comply
				with the current standards of the Americans with Disabilities Act of 1990,
				42 U.S.C. §§
										12101,
et seq.
(1990), as
				amended.
10.4. All MAT program
				facilities must meet all other requirements of applicable federal or state
				regulatory or oversight agencies.
10.5. Life Safety Policies and Procedures.
10.5.a. Each MAT program shall develop,
				implement and maintain policies and procedures regarding the appropriate and
				safe administration of medications and other medical treatment. The policies
				and procedures shall:
10.5.a.1. Ensure that
				the correct dose of medication is administered and that appropriate actions are
				taken if a mistake is made, including a mechanism for reporting unusual
				incidents to appropriate program staff;
10.5.a.2. Establish a current plan of
				emergency administration of medications in case the program must be closed
				temporarily, including how patients will be informed of these emergency
				arrangements;
10.5.a.3. Ensure that
				there is appropriately trained staff on duty at all times who are, at a
				minimum, proficient in cardiopulmonary resuscitation and reversal of opiate
				overdose; and
10.5.a.4. Ensure that
				each medication-assisted treatment medication used by the MAT program is
				administered and dispensed, if applicable, in accordance with its approved
				product labeling. Dosing, dispensing and administration decisions shall be made
				by a program physician familiar with the most up-to-date product labeling.
				These procedures must ensure that any significant deviations from the approved
				labeling, including deviations with regard to dose frequency, or the conditions
				of use described in the approved labeling, are specifically documented in the
				patient's record.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-12 - Plans of Correction

Current through Register Vol. XLI, No. 28, July 12, 2024
12.1.
				Within 10 working days after receipt of the inspection report, the program
				sponsor or administrator shall submit to the Secretary for approval a written
				plan to correct all deficiencies that are in violation of this rule, unless a
				waiver or variance is requested by the MAT program and granted by the
				Secretary. The plan of correction shall specify:
12.1.a. Any action taken or procedures
				proposed to correct the deficiencies and prevent their reoccurrence;
12.1.b. The date of completion or each action
				taken or to be taken; and
12.1.c.
				The signature of the head of the governing body or his or her
				designee.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-13 - Waivers and Variances

Current through Register Vol. XLI, No. 28, July 12, 2024
13.1. The
				Secretary may grant a waiver or variance to the provisions of this rule under
				any of the following circumstances:
13.1.a. A
				strict application of the rule clearly would be impractical and if any
				alternate arrangements are not detrimental to the health or safety of the
				patients or employees of the program; or
13.1.b. A waiver, variance or extension of a
				provisional license is necessary under extraordinary circumstances or otherwise
				to protect public health;
13.1.c.
				The waiver or variance serves the best interests of patient safety and quality
				of care; or
13.1.d. A variance
				pursuant to W. Va. Code §
										16-5Y-5(e).
				The program shall also document where a patient has no insurance. At the option
				of the medication-assisted treatment program, treatment may commence prior to
				billing.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-14 - Reports and Records

Current through Register Vol. XLI, No. 28, July 12, 2024
14.1.
				Inspection Reports and Records.
14.1.a. The
				Secretary shall keep on file a report of any inspection, survey or
				investigation of a MAT program or any program sponsor, owner, employee,
				volunteer or patient thereof.
14.1.b. Information in reports or records
				shall be available to the public except for the following:
14.1.b.1. Information regarding complaint and
				subsequent investigations that is deemed confidential by any provision of this
				rule or applicable state or federal laws;
14.1.b.2. Information of a personal nature
				from a patient or personnel file; or
14.1.b.3. Information required to be kept
				confidential by state or federal law.
14.1.c. A report of an inspection or
				investigation made public shall also state whether a plan of correction has
				been submitted to or approved by the Secretary.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-16 - Risk Management

Current through Register Vol. XLI, No. 28, July 12, 2024
16.1.
				Each MAT program shall:
16.1.a. Obtain a
				voluntary, written, program-specific informed consent to treatment from each
				patient at admission;
16.1.b.
				Inform each patient about all treatment procedures, services and other policies
				and procedures throughout the course of treatment;
16.1.c. Obtain voluntary, written, informed
				consent to the prescribed therapy from each patient before dosing
				begins;
16.1.d. Inform each patient
				that:
16.1.d.1. The goal of
				medication-assisted treatment is recovery, stabilization of functioning and
				establishment of a recovery-oriented lifestyle;
16.1.d.2. Detoxification from opioids or
				other substances is a treatment alternative to an ongoing, recovery-oriented
				plan of care, and that under the detoxification protocol:
16.1.d.2.A. The strength of maintenance doses
				of medication-assisted treatment medications should decrease over time, as
				clinically appropriate; and
16.1.d.2.B. The participant is required to
				work toward a recovery-oriented lifestyle.
16.1.d.3. At each review of the
				individualized treatment plan of care, in full consultation with the patient,
				the program will discuss present level of functioning, course of treatment and
				future long-term recovery goals; and
16.1.d.4. A patient may choose to withdraw
				from or be maintained on the medication as he or she desires, unless medically
				contraindicated.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-17 - Medication Security, Storage, Administration and Documentation

Current through Register Vol. XLI, No. 28, July 12, 2024
17.1. Medication
				Security.
17.1.a. Each MAT program shall
				develop and implement policies and procedures that comply with all relevant
				federal and state laws, rules and regulations regarding the storage and
				management of medications kept at the facility, if applicable, including
				measures that:
17.1.a.1. Ensure responsible
				handling and secure storage of all medications kept at the program;
17.1.a.2. Ensure responsible handling and
				secure storage of all medications kept at the program;
17.1.a.3. Ensure that only authorized
				personnel may access the storage areas where any medications are
				kept.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-18 - Continuous Quality Improvement Policies, Diversion Control Plan

Current through Register Vol. XLI, No. 28, July 12, 2024
18.1. Each MAT
				program shall develop, implement and maintain current quality assurance and
				quality control plans that include provisions for:
18.1.a. Regular and continuous staff
				education;
18.1.b. An annual
				review, in consultation with the advisory council and the peer review committee
				of program policies and procedures;
18.1.c. A service delivery assessment which,
				at a minimum, shall evaluate appropriateness of the individualized treatment
				plan and services delivered, completeness of documentation in patients; records
				and quality of and participation in staff training programs, linkage to a
				utilization of primary care and other out-of-program services, and availability
				of services and medications for other conditions;
18.1.d. Consideration of ongoing input into
				program policies and procedures by patients regarding community
				concerns;
18.1.e. Development and
				implementation of annual patient satisfaction surveys that include a review of
				patient satisfaction;
18.1.f. An
				ongoing assessment, measurement and monitoring of patient outcomes, treatment
				outcomes and the various processes including, but not limited to:
18.1.f.1. Reduction or elimination of the
				patient's use of illicit opioids, illicit drugs and the problematic use of
				licit drugs;
18.1.f.2. Reduction or
				elimination of associated criminal activities;
18.1.f.3. Reduction of the patient's
				behaviors contributing to the spread of infectious diseases;
18.1.f.4. Improvement of quality of life
				through the restoration of physical and behavioral health and functional
				status, including employment or volunteerism, as may be appropriate;
				and
18.1.f.5. Assessment of
				medication-related issues, including, but not limited to, take-home procedures,
				security, inventory and dosage issues.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-22 - Multiple Program Enrollments

Current through Register Vol. XLI, No. 28, July 12, 2024
22.1. A
				patient enrolled in a MAT program shall not be permitted to obtain treatment in
				any other MAT program except in exceptional circumstances.
22.1.a. If the medical director or program
				physician of the MAT program in which the patient is enrolled determines that
				an exceptional circumstance exists, the patient may be granted permission to
				seek treatment at another MAT program.
22.1.b. The justification for finding
				exceptional circumstances shall be noted in the patient's individualized
				treatment plan of care and medical chart both at the MAT program in which the
				patient is enrolled and at the MAT program that provides the additional
				treatment.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-23 - Controlled Substances Monitoring Program Database

Current through Register Vol. XLI, No. 28, July 12, 2024
23.1. Each MAT program shall comply with
				policies and procedures developed by the designated state oversight agency and
				the West Virginia Board of Pharmacy to allow physicians treating patients
				through a MAT program access to the Controlled Substances Monitoring Program
				database maintained by the West Virginia Boar of Pharmacy.
23.2. The program physician shall access the
				Controlled Substances Monitoring Program database in order to ensure that the
				patient is not seeking prescription medication from multiple sources. The
				results obtained from the database shall be maintained with the patient
				records.
23.3. Program physicians
				shall access the database:
23.3.a. At the
				patient's intake;
23.3.b. Before
				the administration of medication-assisted treatment medications or other
				treatment in a MAT program;
23.3.c.
				After the initial 30 days of treatment;
23.3.d. Prior to any take-home medication
				being granted, if applicable;
23.3.e. After any positive drug test;
				and
23.3.f. At each 90-dat
				treatment review.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-26 - Counseling

Current through Register Vol. XLI, No. 28, July 12, 2024
26.1. Each MAT
				program shall provide substance use disorder counseling to every patient as is
				clinically appropriate. Counseling sessions should encourage and guide the
				patient to a lifestyle that does not include abuse or misuse of prescribed and
				illicit medications, drugs or other substances. Counseling sessions are
				essential to promote and guide the patient to a more productive lifestyle of
				abstinence from illicit medications or drugs.
26.2. The counseling shall be provided by a
				counselor or other professional as described in this rule, qualified by
				education or training to assess the psychological and sociological background
				of patients, to contribute to the appropriate individualized treatment plan for
				the patient, and to monitor patient progress. The primary counselor shall
				develop and implement the psychological and social portions of the patient's
				individualized treatment plan of care, in coordination with the medical staff
				and program physician. The individualized treatment plan of care shall address
				the social, environmental, psychological, social and familial issues relative
				to recognizing, correcting and eliminating the individual's maladaptive
				patterns of drug consumption and other high risk or destructive
				behaviors.
26.3. The primary
				counselor is responsible for assisting the patient in altering lifestyles and
				patterns of behavior in order to improve the individual's ability to function
				adaptively in his or her family and community. Counseling shall address the
				social, environmental, psychological and familial issues that contribute to the
				individual's maladaptive patterns of drug consumption and other high risk or
				destructive behaviors.
26.4. Each
				MAT program shall provide counseling on matters indirectly related to substance
				use disorder, including, but not limited to:
26.4.a. Preventing exposure to, and the
				transmission of, HIV and hepatitis C for each patient admitted or readmitted to
				maintenance or detoxification treatment; and
26.4.b. Domestic violence, sexual abuse and
				anger management.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-28 - Physical and Biopsychosocial Assessments

Current through Register Vol. XLI, No. 28, July 12, 2024
28.1. The program shall complete a physical
				and biopsychosocial evaluation, which shall be used to develop the long-term
				individualized treatment plan of care. The physical and biopsychosocial
				evaluations shall integrate information obtained in all treatment of the
				patient at the MAT program.
28.2.
				The physical and biopsychosocial evaluations shall include information obtained
				from:
28.2.a. The patient;
28.2.b. Family members, when applicable and
				permitted;
28.2.c. Friends and
				peers, when appropriate and permitted; and
28.2.d. Other appropriate and permitted
				collateral sources.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-32 - Administrative Withdrawal

Current through Register Vol. XLI, No. 28, July 12, 2024
32.1.
				Administrative withdrawal is an involuntary withdrawal or administrative
				discharge from pharmacotherapy. The schedule of withdrawal may be brief; less
				than 30 days, if necessary.
32.2.
				MAT programs shall develop and implement policies and procedures for the
				involuntary termination from treatment that includes and describes the rights
				of the patient and the responsibilities and rights of the program.
32.3. On admission, the patient shall be
				given a copy of the administrative withdrawal policies and procedures and shall
				sign a statement acknowledging receipt of the same. The signed acknowledgement
				shall be maintained in the patient's record.
32.4. Administrative withdrawal may result
				from any of the following:
32.4.a. Non-payment
				of fees. The MAT program shall make every effort to consider all clinical data,
				including patient participation and compliance with treatment prior to
				initiating administrative withdrawal for non-payment. If the patient has a
				history of compliance and cooperation with treatment, the program shall
				document every effort to explore alternatives to administrative withdrawal with
				the patient prior to onset of withdrawal. If necessary and unavoidable, the
				schedule of withdrawal shall follow protocols and guidelines of approved
				authorities.
32.4.b. Disruptive or
				adverse effect conduct. Disruptive conduct or behavior considered to have an
				adverse effect on the program, clinical staff or patient population of such
				gravity as to justify the involuntary withdrawal and discharge of a patient.
				Such behaviors may include violence, threat of violence, dealing drugs,
				diversion of pharmacological agents, repeated loitering, failure to follow
				treatment plan objectives or noncompliance with program rules, policies and
				procedures resulting in an observable, negative impact on the program, staff
				and other patients.
32.4.c.
				Incarceration or other confinement. The MAT program is responsible for working
				with law enforcement and corrections personnel in order to avoid mandatory
				withdrawal whenever possible.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-33 - Medical Withdrawal

Current through Register Vol. XLI, No. 28, July 12, 2024
33.1.
				Medical withdrawal occurs as a voluntary and therapeutic withdrawal agreed upon
				by clinical staff and the patient in accordance with approved national
				guidelines including, but not limited to, ASAM, CSAT, NIDA, AATOD, FSMB and
				SAMHSA. In some cases, the withdrawal may be against the advice of clinical
				staff or against medical advice.
33.2. The MAT program shall supply a schedule
				of dose reduction well tolerated by the patient.
33.3. The program shall offer supportive
				treatment, including increased counseling sessions and referral to a self-help
				group or other counseling provider as appropriate.
33.4. If the patient leaves the MAT program
				abruptly against medical advice, the program may readmit the patient within 30
				days without a formal reassessment procedure. However, the program must perform
				a physical assessment and a biopsychosocial assessment upon readmission. The
				program shall document attempting to assist the patient with any issues which
				may have triggered his or her abrupt departure.
33.5. The MAT program shall make provisions
				for continuing care for each patient following the last dose of medication and
				for re-entry to maintenance treatment if relapse occurs or if the patient
				should reconsider withdrawal.
33.6.
				Female patients shall have a negative pregnancy screen prior to the onset of
				medically-supervised withdrawal.
33.7. The program shall have in place a
				detailed relapse prevention plan developed by the primary counselor in
				accordance with approved national guidelines and in conjunction with the
				patient. The prevention plan shall be given to the patient in writing prior to
				the administration of the final dose of medication.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-35 - Special Populations

Current through Register Vol. XLI, No. 28, July 12, 2024
35.1.
				Concurrent Alcohol and Polysubstance Abuse.
35.1.a. Each MAT program shall address abuse
				of alcohol and other non-opioid substances within the context of the
				medication-assisted therapy effort.
35.1.b. The MAT program shall ensure that its
				staff is fully trained and knowledgeable regarding current effective strategies
				for treating alcohol, cocaine, and other drug abuse.
35.1.c. Ongoing polysubstance use is not a
				reason for discharge unless the patient refuses recommended, more intensive
				levels of care. The interdisciplinary team shall consider the patient's
				condition and address the situation from a clinical perspective and in
				accordance with guidelines and protocols from approved authorities.
35.1.d. Each MAT program shall have a policy
				regarding treatment of co-morbid disorders such as psychiatric and medical
				disorders. The goal of the treatment shall be to provide treatment for these
				disorders in as seamless a fashion as possible, maximizing patient convenience
				and compliance with appointments and recommendations. The program shall develop
				interagency agreements whenever possible to ensure smooth referral processes
				and interchange of information.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-36 - Advertisement Disclosure

Current through Register Vol. XLI, No. 28, July 12, 2024
Any advertisement made by or on behalf of a MAT program
				  through public media, such as a telephone directory, medical directory,
				  newspaper or other periodical, outdoor advertising, radio or television, or
				  through written or recorded communication, concerning the treatment of
				  substance use disorder shall include the name of, at a minimum, one program
				  physician responsible for the content of the advertisement.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-37 - Licensure Denials, Revocations and Suspensions

Current through Register Vol. XLI, No. 28, July 12, 2024
37.1. Grounds for Denial, Revocation or
				Suspension.
37.1.a. The Secretary may deny,
				revoke or suspend a license issued pursuant to this rule if any provisions of
				federal or state law or this rule are violated. The Secretary may revoke a
				license and prohibit all program physicians associated with that MAT program
				from practicing at the program location based upon the findings and results of
				an annual, periodic, complaint or other inspection and evaluation. The period
				of suspension for the license of a MAT program shall be prescribed by the
				Secretary, but may not exceed one year.
37.1.b. The Secretary may deny, revoke or
				suspend a MAT program license for one or more the following reasons:
37.1.b.1. The Secretary makes a determination
				that fraud or other illegal action has been committed by any owner of the MAT
				program.
37.1.b.2. The MAT program
				has violated federal, state or local law relating to licensure, registration,
				building, health, fire protection, safety, sanitation or zoning;
37.1.b.3. The MAT program engages in
				practices that jeopardize the health, safety, welfare or clinical treatment of
				a patient;
37.1.b.4. The MAT
				program has failed or refused to submit reports or make records available as
				requested by the Secretary;
37.1.b.5. A MAT program has refused to
				provide access to its location or records as requested by the
				Secretary;
37.1.b.6. A MAT
				program's medical director has knowingly and intentionally misrepresented
				actions taken to correct a violation;
37.1.b.7. An owner or medical director of a
				MAT program concurrently operates an unlicensed MAT program;
37.1.b.8. A program physician or any owner
				knowingly operates, owns or manages an unlicensed MAT program that is required
				to be licensed;
37.1.b.9. The
				owners of a MAT program fail to apply for a new license for the program upon a
				change of ownership and operate the program under the new ownership;
37.1.b.10. A program physician or any owner
				acquires or attempts to acquire a license for a MAT program through
				misrepresentation or fraud or procures or attempts to procure a license for a
				MAT program for any other person by making or causing to be made any false
				representation; or
37.1.b.11. The
				MAT program fails to have a medical director practicing at the program location
				as required by this rule.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-38 - Penalties and Equitable Relief

Current through Register Vol. XLI, No. 28, July 12, 2024
38.1.
				Grounds for Penalties and Injunctions.
38.1.a. Any person, partnership, association
				or corporation which establishes, conducts, manages or operates a MAT program
				without first obtaining a license therefore or which violates any provisions of
				law or rule shall be assessed a civil money penalty by the Secretary in
				accordance with this rule.
38.1.b.
				Each day of continuing violation after notification of the infraction shall be
				considered a separate violation.
38.1.c. If the MAT program fails to timely
				file reports required by section 14 of this rule, the Secretary may impose a
				civil monetary penalty not to exceed $1,000 per day.
38.1.d. If the MAT program's owner or owners,
				medical director and administrator knowingly and intentionally misrepresents
				actions taken to correct a violation, the Secretary may impose a civil money
				penalty not to exceed $10,000 and revoke or deny the MAT program's
				license.
38.1.e. If an owner or
				owners or medical director of a MAT program concurrently operates an unlicensed
				MAT program, the Secretary may impose a civil money penalty upon the owner or
				owners or medical director, or both, not to exceed $5,000 per day.
38.1.f. If the owner of a MAT program that
				requires a license under this article fails to apply for a new license for the
				program upon a change of ownership and operates the program under the new
				ownership, the Secretary may impose a civil money penalty not to exceed
				$5,000.
38.1.g. If a program
				physician knowingly operates, owns or manages an unlicensed MAT program that is
				required to be licensed pursuant to this article; knowingly prescribes or
				dispenses or causes to be prescribed or dispensed, controlled substances in an
				unlicensed MAT program that is required to be licensed; or obtains a license to
				operate a MAT program through misrepresentation or fraud; procures or attempts
				to procure a license for a MAT program for any other person by making or
				causing to be made any false representation, the Secretary may assess a civil
				money penalty of not more than $20,000. The penalty may be in addition to or in
				lieu of any other action that may be taken by the Secretary or any other board,
				court or entity.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-39 - Administrative Due Process

Current through Register Vol. XLI, No. 28, July 12, 2024
39.1.
				Before any MAT program license is denied, suspended or revoked, written notice
				shall be given to the owner or owners of the program, stating the grounds of
				the denial, suspension, revocation or penalty and the date set for any
				enforcement action.
39.1.a. The notice shall
				be sent by certified mail to the owner(s) at the address where the MAT program
				concerned is located.
39.1.b.
				Within 30 days of receipt of the notice, the owner(s) may submit a request for
				an administrative hearing or an informal meeting to address and resolve the
				findings.
39.1.c. The MAT program
				and its owner or owners shall be entitled to be represented by legal counsel at
				the informal meeting or at the hearing at their own expense.
39.1.d. All of the pertinent provisions of W.
				Va. Code §§
										29A-5-1,
et seq.
and 69 CSR 1 shall apply to and govern any hearing
				authorized by this rule.
39.1.e. If
				an owner fails to request a hearing within the time frame specified, he or she
				shall be subject to the full penalty imposed.
39.1.f. The filing of a request for a hearing
				does not stay or supersede enforcement of the final decision or order of the
				Secretary. The Secretary may, upon good cause shown, stay such
				enforcement.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs › Section 69-11-40 - Administrative Appeals and Judicial Review

Current through Register Vol. XLI, No. 28, July 12, 2024
40.1. Any owner of a MAT program who
				disagrees with the final administrative decision as a result of the hearing
				may, within 30 days after receiving notice of the decision, appeal the decision
				to the Circuit Court of Kanawha County or in the county where the petitioner
				resides or does business.
40.1.a. The filing
				of a petition for appeal does not stay or supersede enforcement of the final
				decision or order of the Secretary. An appellant may appeal to the circuit
				court for a stay of or to supersede the final decision or order.
40.1.b. The Circuit Court may affirm, modify
				or reverse the final administrative decision. The owner or owners, or the
				Secretary may appeal the court's decision to the Supreme Court of
				Appeals.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-12 - Medication-Assisted Treatment - Office-Based Medication-Assisted Treatment › Section 69-12-1 - General

Current through Register Vol. XLI, No. 28, July 12, 2024
1.1. Scope. -- This
				legislative rule establishes standards and procedures for the licensure and
				regulation of medication-assisted treatment - office-based medication-assisted
				treatment (OBMAT) programs.
1.2.
				Authority. -- W. Va. Code §16-5Y-1,
et
				seq
.
1.3. Filing Date. --
				May 3, 2024.
1.4. Effective Date.
				-- May 3, 2024.
1.5. Sunset
				Provision. -- This rule shall terminate and have no further force or effect on
				August 1, 2029.
1.6. Purpose. --
				The purpose of this rule is to ensure that all West Virginia OBMAT programs
				conform to a common set of minimum standards and procedures to ensure the care,
				treatment, health, safety and welfare of patients therein.
1.7. Enforcement. -- This rule is enforced by
				the Secretary of the Department of Health and Human Resources or his or her
				designee.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-12 - Medication-Assisted Treatment - Office-Based Medication-Assisted Treatment › Section 69-12-3 - State Opioid Treatment Authority

Current through Register Vol. XLI, No. 28, July 12, 2024
3.1. The Secretary has designated the Bureau
				of Behavioral Health and Health Facilities as the state opioid treatment
				authority.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-12 - Medication-Assisted Treatment - Office-Based Medication-Assisted Treatment › Section 69-12-4 - State Oversight Authority; Powers and Duties

Current through Register Vol. XLI, No. 28, July 12, 2024
4.1. The Secretary has designated the Office
				of Health Facility Licensure and Certification (OHFLAC) within the Department
				of Health and Human Resources to act as the state oversight agency, as that
				agency is defined in this rule. OHFLAC shall provide regulatory oversight,
				regulation, and inspection of OBMAT programs.
4.2. The powers and duties of the state
				oversight agency include, but are not limited to, the following:
4.2.1. Develop and implement rules regarding
				the registration and oversight of OBMAT programs;
4.2.2. Accept applications and fees for
				registration of OBMAT programs and conduct all necessary reviews, inspections,
				or investigations in order to determine whether a registration should be
				issued;
4.2.3. Issue initial,
				amended, and renewed registration to an OBMAT program upon a determination that
				the program is qualified;
4.2.4.
				Perform both scheduled and unscheduled site visits to OBMAT programs when
				necessary and appropriate;
4.2.5.
				Monitor the activities of all OBMAT programs to ensure compliance with all
				state and federal requirements;
4.2.6. Receive and act upon
				complaints;
4.2.7. Inspect
				allegations of rule violations, unauthorized activities, or other conduct that
				may affect the health, safety, or well-being of patients or employees of an
				OBMAT program;
4.2.8. Assist an
				OBMAT program in developing a plan of correction in order to correct any noted
				violations or deficiencies;
4.2.9.
				Deny, revoke, or suspend the registration of an OBMAT program in accordance
				with the applicable administrative proceedings; and
4.2.10. Perform all other necessary actions
				related to the registration, monitoring, investigating, and oversight of OBMAT
				programs.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-12 - Medication-Assisted Treatment - Office-Based Medication-Assisted Treatment › Section 69-12-5 - Applicability

Current through Register Vol. XLI, No. 28, July 12, 2024
5.1. Hospitals that
				are licensed under "Hospital Licensure," W. Va. Code R. §64-12-1,
et seq.
,
				and behavioral health facilities that are licensed under Behavioral Health
				Centers Licensure," W. Va. Code R. §64-11-1,
et seq.
,
				and which provide outpatient medication-assisted treatment as defined in W. Va.
				Code §16-5Y-2 are subject to the
				provisions of this rule and to all other relevant federal and state
				registration requirements as specified by the Secretary.
5.2. An OBMAT program directly operated by
				the Department of Veterans Affairs, the Indian Health Service or any other
				department or agency of the United States is not required to obtain a state
				registration.
5.3. Crisis
				Stabilization Units (CSU) are not required to obtain a state registration if
				the following conditions are met:
5.3.1.
				Treatment at the CSU is utilized only for detoxification or initiation of
				medication-assisted treatment, or both, or for treatment of a co-occurring
				disorder of an of an existing medication-assisted treatment client;
				and
5.3.2. The CSU must document
				the referral of the patient to an appropriate MAT program upon discharge from
				the CSU.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-12 - Medication-Assisted Treatment - Office-Based Medication-Assisted Treatment › Section 69-12-7 - Administrative Organization and Management of OBMAT Programs

Current through Register Vol. XLI, No. 28, July 12, 2024
7.1. Each OBMAT program shall identify a
				program administrator, medical director, program physician(s), and, if
				applicable, counseling staff.
7.2.
				Program Administrator.
7.2.1. The
				administrator of an OBMAT program shall have at a minimum a bachelor's degree
				in an appropriate area of study and a minimum of two years of experience in the
				fields of substance use disorders, behavioral health, or health care
				administration; or a master's degree in an appropriate professional area of
				study; or six years of experience in the fields of substance use disorders,
				behavioral health, or health care administration; or be a program
				physician.
7.2.2. The administrator
				is responsible for the day-to-day operation of the OBMAT program in a manner
				consistent with the laws and regulations of the United States Department of
				Health and Human Services, Drug Enforcement Administration (DEA), and the laws
				and rules of the state of West Virginia.
7.2.3. Duties of the administrator include:
7.2.3.a. Contribution to the development of
				policies and procedures for operation of the program;
7.2.3.b. Maintenance and security of the
				facility;
7.2.3.c. Employment,
				credentialing, evaluation, scheduling, training, and management of
				staff;
7.2.3.d. Protection of
				patient rights;
7.2.3.e. Conformity
				of the program with federal confidentiality regulations, namely, 42 C.F.R. Part
				2;
7.2.3.f. Security of medication
				storage and safe handling of medications;
7.2.3.g. Contribution to the management of
				the facility budget;
7.2.3.h.
				Implementation of program policies and procedures;
7.2.3.i. Communication with the medical
				director; and
7.2.3.j. Maintenance
				of documentation regarding the medical director's training and experience in a
				file that is current and readily available at all times.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-12 - Medication-Assisted Treatment - Office-Based Medication-Assisted Treatment › Section 69-12-8 - Environment and Operation

Current through Register Vol. XLI, No. 28, July 12, 2024
8.1.
				Service Operation Schedule.
8.1.1. Programs,
				especially sole practitioners of OBMAT programs, shall ensure that services are
				not interrupted due to staff vacations by having qualified, temporary
				coverage.
8.1.2. Except as
				otherwise provided herein, the program's days of operation shall meet the needs
				of the OBMAT program patients served.
8.1.3. The program shall notify the patients
				receiving medication-assisted treatment services in writing at least 30 days in
				advance of their intent to permanently change service hours.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-12 - Medication-Assisted Treatment - Office-Based Medication-Assisted Treatment › Section 69-12-9 - Life Safety Policies and Procedures

Current through Register Vol. XLI, No. 28, July 12, 2024
9.1. All OBMAT program facilities must meet
				all other requirements of applicable federal or state regulatory or oversight
				agencies.
9.2. Life Safety Policies
				and Procedures.
9.2.1. Each OBMAT program
				shall develop, implement, and maintain policies and procedures regarding the
				appropriate and safe administration of medical treatment. The policies and
				procedures shall:
9.2.1.a. Establish a current
				emergency plan in case the program must be closed temporarily, including how
				patients will be informed of these emergency arrangements; and
9.2.1.b. Ensure that there is appropriately
				trained staff on duty at all times who are proficient in cardiopulmonary
				resuscitation and reversal of opiate overdose.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-12 - Medication-Assisted Treatment - Office-Based Medication-Assisted Treatment › Section 69-12-10 - For-Cause Inspections; Complaints

Current through Register Vol. XLI, No. 28, July 12, 2024
10.1. The Secretary may conduct unannounced
				inspections of an OBMAT program for cause if the Secretary has received a
				complaint about the program or has reason to believe that the program may be
				operating in violation of federal or state statutes, rules, or regulations, may
				be providing substandard treatment or may be serving as possible source of
				diverted medications.
10.2. Any
				person may file a complaint with the Secretary alleging violation of applicable
				laws, rules, or policies by an OBMAT program. A complaint shall identify the
				OBMAT program by name and state the nature of the complaint.
10.3. At the time of any onsite investigation
				activities, the investigator shall notify the medical director or program
				administrator at the OBMAT program of the general reason for the
				investigation.
10.4. Within 15
				working days of the investigation, the Secretary shall provide to the medical
				director or program administrator at an OBMAT program a written report of the
				results of the investigation. The report shall specify any deficiency found and
				the rule that forms the basis for the violation.
10.5. The Secretary may permit the OBMAT
				program to develop a plan of correction to address any noted violations or
				deficiencies. The Secretary may advise and consult with the medical director,
				program administrator, or other personnel at an OBMAT program to assist with a
				plan of correction.
10.6. The
				Secretary may impose a civil money penalty, suspend, or revoke a registration
				or take such other action as deemed appropriate to address any violations or
				deficiencies. In the event the Secretary determines that the continued
				operation of the OBMAT program is a threat to the health, welfare and safety of
				its patients or employees, the Secretary may issue an order immediately closing
				the facility pursuant to applicable administrative procedures.
10.7. Upon completion of the investigation,
				the Secretary shall notify the complainant whether the allegations have been
				substantiated and how to obtain a copy of the report.
10.8. The Secretary shall keep confidential
				any information that could reasonably lead to the identification of a
				complainant and of any patient involved in the complaint or investigation. The
				Secretary shall not disclose such information without the written consent of
				the complainant or patient. The Secretary shall delete any identifying
				information before disclosure of investigative information to the
				public.
10.9. If a complaint
				becomes the subject of a judicial proceeding, nothing in this rule prohibits
				the disclosure of information that would otherwise be disclosed in judicial
				proceedings.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-12 - Medication-Assisted Treatment - Office-Based Medication-Assisted Treatment › Section 69-12-11 - Plans of Correction

Current through Register Vol. XLI, No. 28, July 12, 2024
11.1.
				Within 10 working days after receipt of the inspection report, the program
				administrator or medical director at an OBMAT program shall submit to the
				Secretary for approval a written plan to correct all deficiencies that are in
				violation of this rule or statute, unless a waiver or variance is requested by
				the OBMAT program and granted by the Secretary. The plan of correction shall
				specify:
11.1.1. Any action taken, or
				procedures proposed to correct the deficiencies and prevent their
				reoccurrence;
11.1.2. The date of
				completion or each action taken or to be taken; and
11.1.3. The signature of the medical
				director, or his or her designee, or other executive officer of the
				program.
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-12 - Medication-Assisted Treatment - Office-Based Medication-Assisted Treatment › Section 69-12-12 - Waivers and Variances

Current through Register Vol. XLI, No. 28, July 12, 2024
12.1. The
				Secretary may grant a waiver or variance to the provisions of this rule under
				any of the following circumstances:
12.1.1. A
				strict application of the rule clearly would be impractical and if any
				alternate arrangements are not detrimental to the health or safety of the
				patients or employees of the program;
12.1.2. A waiver, variance, or extension of a
				provisional registration is necessary under extraordinary circumstances or
				otherwise to protect public health;
12.1.3. The waiver or variance serves the
				best interests of patient safety and quality of care; or
12.1.4. A variance is granted pursuant to W.
				Va. Code §16-5Y-5(e).
West Virginia Code of State Rules › Agency 69 - Health And Human Resources › Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES › Series 69-12 - Medication-Assisted Treatment - Office-Based Medication-Assisted Treatment › Section 69-12-13 - Reports and Records

Current through Register Vol. XLI, No. 28, July 12, 2024
13.1.
				Inspection Reports and Records.
13.1.1. The
				secretary shall keep on file a report of any inspection, survey, or
				investigation of an OBMAT program or any program sponsor, owner, employee,
				volunteer, or patient thereof.
13.1.2. Information in reports or records
				shall be available to the public except for the following:
13.1.2.a. Information regarding complaints
				and subsequent investigations that is deemed confidential by any provision of
				this rule or applicable state or federal laws;
13.1.2.b. Information of a personal nature
				from a patient or personnel file; or
13.1.2.c. Information required to be kept
				confidential by state or federal law.
13.1.3. A report of an inspection or
				investigation made public shall also state whether a plan of correction has
				been submitted to or approved by the secretary.