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SB447 SUB1 Senate Bill 447 History

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COMMITTEE SUBSTITUTE

FOR

Senate Bill No. 447

(By Senators Caruth, Prezioso, Stollings, Jenkins, McKenzie and Guills)

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[Originating in the Committee on Health and Human Resources;

reported February 27, 2007.]

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A BILL to amend and reenact §16-1-4 of the Code of West Virginia, 1931, as amended, relating generally to the regulation of opioid treatment centers; and providing for specific minimum requirements established by the rules provided in said section.

Be it enacted by the Legislature of West Virginia:
That §16-1-4 of the Code of West Virginia, 1931, as amended, be amended and reenacted to read as follows:
§16-1-4. Proposal of rules by the secretary.
The secretary may propose rules, in accordance with the provisions of article three, chapter twenty-nine-a of this code, that are necessary and proper to effectuate the purposes of this chapter. The secretary may appoint or designate advisory councils of professionals in the areas of hospitals, nursing homes, barbers and beauticians, postmortem examinations, mental health and mental retardation centers and any other areas necessary to advise the secretary on rules.
The rules may include, but are not limited to, the regulation of:
(a) Land usage endangering the public health: Provided, That no rules may be promulgated or enforced restricting the subdivision or development of any parcel of land within which the individual tracts, lots or parcels exceed two acres each in total surface area and which individual tracts, lots or parcels have an average frontage of not less than one hundred fifty feet even though the total surface area of the tract, lot or parcel equals or exceeds two acres in total surface area, and which tracts are sold, leased or utilized only as single family dwelling units. Notwithstanding the provisions of this subsection, nothing in this section may be construed to abate the authority of the department to: (1) Restrict the subdivision or development of a tract for any more intense or higher density occupancy than a single family dwelling unit; (2) propose or enforce rules applicable to single family dwelling units for single family dwelling unit sanitary sewerage disposal systems; or (3) restrict any subdivision or development which might endanger the public health, the sanitary condition of streams or sources of water supply;
(b) The sanitary condition of all institutions and schools, whether public or private, public conveyances, dairies, slaughterhouses, workshops, factories, labor camps, all other places open to the general public and inviting public patronage or public assembly, or tendering to the public any item for human consumption, and places where trades or industries are conducted;
(c) Occupational and industrial health hazards, the sanitary conditions of streams, sources of water supply, sewerage facilities and plumbing systems and the qualifications of personnel connected with any of those facilities, without regard to whether the supplies or systems are publicly or privately owned; and the design of all water systems, plumbing systems, sewerage systems, sewage treatment plants, excreta disposal methods and swimming pools in this state, whether publicly or privately owned;
(d) Safe drinking water, including:
(1) The maximum contaminant levels to which all public water systems must conform in order to prevent adverse effects on the health of individuals, and, if appropriate, treatment techniques that reduce the contaminant or contaminants to a level which will not adversely affect the health of the consumer. The rule shall contain provisions to protect and prevent contamination of wellheads and well fields used by public water supplies so that contaminants do not reach a level that would adversely affect the health of the consumer;
(2) The minimum requirements for: Sampling and testing; system operation; public notification by a public water system on being granted a variance or exemption or upon failure to comply with specific requirements of this section and rules promulgated under this section; record keeping; laboratory certification; as well as procedures and conditions for granting variances and exemptions to public water systems from state public water systems rules; and
(3) The requirements covering the production and distribution of bottled drinking water and may establish requirements governing the taste, odor, appearance and other consumer acceptability parameters of drinking water;
(e) Food and drug standards, including cleanliness, proscription of additives, proscription of sale and other requirements in accordance with article seven of this chapter as are necessary to protect the health of the citizens of this state;
(f) The training and examination requirements for emergency medical service attendants and emergency medical care technician-paramedics; the designation of the health care facilities, health care services and the industries and occupations in the state that must have emergency medical service attendants and emergency medical care technician-paramedics employed and the availability, communications and equipment requirements with respect to emergency medical service attendants and to emergency medical care technician-paramedics: Provided, That any regulation of emergency medical service attendants and emergency medical care technician-paramedics shall not exceed the provisions of article four-c of this chapter;
(g) The health and sanitary conditions of establishments commonly referred to as bed and breakfast inns. For purposes of this article, "bed and breakfast inn" means an establishment providing sleeping accommodations and, at a minimum, a breakfast for a fee: Provided, That the secretary may not require an owner of a bed and breakfast providing sleeping accommodations of six or fewer rooms to install a restaurant style or commercial food service facility: Provided, however, That the secretary may not require an owner of a bed and breakfast providing sleeping accommodations of more than six rooms to install a restaurant-type or commercial food service facility if the entire bed and breakfast inn or those rooms numbering above six are used on an aggregate of two weeks or less per year;
(h) Fees for services provided by the bureau for public health including, but not limited to, laboratory service fees, environmental health service fees, health facility fees and permit fees;
(i) The collection of data on health status, the health system and the costs of health care;
(j) Opioid treatment programs duly licensed and operating under the requirements of chapter twenty-seven of this code. The secretary shall promulgate
revised emergency rules to govern such programs: Provided, That there shall be a moratorium on the licensure of new opioid treatment programs that do not have a certificate of need as of the effective date of the two thousand seven amendments to this subsection until such time as the secretary files revised emergency rules with the secretary of state to regulate such programs in compliance with subsections (1) through (8), inclusive, of this section and thereafter until the Legislature has undertaken and completed a study of the adequacy of the rule regulating opioid treatment programs and of the necessity for additional opioid treatment program facilities in addition to the currently licensed and operating opioid treatment program facilities. The moratorium will remain in effect unless and until such time as the legislature determines that there is a necessity for additional opioid treatment facilities in West Virginia: Provided, That any opioid treatment program facility that has received a certificate of need pursuant to section twenty, article twenty-nine-a, chapter sixteen of this code by the Health Care Authority shall be permitted to proceed to license and operate the facility. All existing opioid treatment programs shall be in compliance within one hundred eighty days of the effective date of this rule; and the revised emergency rules as required herein. The revised emergency rules shall provide at a minimum:
(1) That the initial assessment prior to admission for entry into the opioid treatment program shall include an initial drug test to determine whether an individual is either opioid addicted or presently receiving methadone for an opioid addiction from another opioid treatment program. The patient may be admitted to the program if there is a positive test for either opioids or methadone or there are objective symptoms of withdrawal, or both, and all other criteria set forth in the rule for admission into an opioid treatment program are met: Provided, That admission to the program may be allowed to the following groups with a high risk of relapse without the necessity of a positive test or the presence of objective symptoms: Pregnant woman with a history of opioid abuse, prisoners or parolees recently released from correctional facilities, former clinic patients who have successfully completed treatment but who believe themselves to be at risk of imminent relapse and HIV patients with a history of intravenous drug use. (2) That within seven days of the admission of a patient, the opioid treatment program shall develop an initial assessment and an initial plan of care. Subsequently, the opioid treatment program shall develop a treatment plan of care at the thirtieth day after the admission of the patient to the program. Within five days of completion of the plan of care, it shall be filed in the patient's chart. When developing the treatment plan, the opioid treatment program shall include and encourage detoxification as an option available for treatment.
(3) That each opioid treatment program shall report and provide statistics to the Department of Health and Human Resources at least semi annually which includes the total number of patients; the number of patients who have been continually receiving methadone treatment for in excess of two years, including the total number of months of treatment for each such patient who has been continuously receiving methadone treatment for in excess of two years; the number of patients who have discontinued the program, including the total months in the treatment program for each such discontinued patient and whether such discontinuation was for:
(A) Termination or disqualification;
(B) Completion of a program of detoxification;
(C) Voluntary withdrawal prior to completion of all requirements of detoxification as determined by the opioid treatment program; or
(D) An unexplained reason.
(4) That random drug testing of patients be conducted during the course of treatment. For purposes of these rules, random drug testing shall mean that each patient of an opioid treatment program facility has a substantially equal chance of being selected for testing at random and at unscheduled times. Any unexcused absence from a random drug test shall be considered a positive test:
Provided, That nothing contained in this section or the legislative rules promulgated in conformity herewith will preclude any opioid treatment program from administering such additional drug tests as determined necessary by the opioid treatment program.
(5) That all random drug tests conducted by an opioid treatment program shall, at a minimum, test for the following:
(A) Opiates, including oxycodone at common levels of dosing;
(B) Methadone and any other medication used by the program as an intervention;
(C) Bezodiazepines including diazepam, lorazepan, clonazepam and alprazolam;
(D) Cocaine;
(E) Methamphetamine or amphetamine; and
(F) Other drugs determined by community standards, regional variation or clinical indication.
A positive test shall be a test that results in the presence of any drug or substance listed in this schedule and any other drug or substance prohibited by the opioid treatment program;
(6) That a positive drug test result after the first six months in an opioid treatment program shall result in the following:
(A) Upon the first positive drug test result, the opioid treatment program shall:
(1) Provide mandatory and documented weekly counseling to the patient, which shall include weekly meetings with a licensed counselor who is certified in compliance with the rules and on staff at the opioid treatment program; and
(2)Immediately revoke the take home methadone privilege for a minimum of thirty days.
(B) Upon a second positive drug test result within six months of a previous positive drug test result, the opioid treatment program shall:
(1) Immediately revoke the take home methadone privilege for a minimum of sixty days; and
(2) Provide mandatory and documented weekly counseling, which shall include weekly meetings with a licensed counselor who is certified in compliance with the rules and on staff at the opioid treatment program; and
(3) Provide mandatory documented treatment team meetings with the patient.
(C) Upon a third positive drug test result within a period of six months the opioid treatment program shall:
(1) Immediately revoke the take home methadone privilege for a minimum of one hundred twenty days; and
(2) Provide mandatory and documented weekly counseling, which shall include weekly meetings with a licensed counselor who is certified in compliance with the rules and on staff at the opioid treatment program; and
(3) Provide mandatory and documented treatment team meetings with the patient which will include, at a minimum: The need for continuing treatment; a discussion of other treatment alternatives; and the execution of a contract with the patient advising the patient of discharge for continued positive drug tests.
(D) Upon a fourth positive drug test within a six-month period, the patient shall be immediately discharged from the opioid treatment program, or, at the option of the patient, shall immediately be provided the opportunity to participate in a 21-day detoxification plan, followed by immediate discharge from the opioid treatment program.
(7) That the opioid treatment program must report and provide statistics to the Department of Health and Human Resources demonstrating compliance with the random drug test rules including confirmation that:
(A) The random drug tests were truly random in regard to both the patients tested and to the times random drug tests were scheduled by lottery or some other objective standard so as not to prejudice or protect any particular patient.
(B) The total number and the times of all drug tests and the number of positive results; and
(C) The number of expulsions from the program.
(8) That all opioid treatment facilities be open for business seven days per week. An opioid treatment facility may be closed on all legal holidays as defined in section one, article two, chapter two of this code if provisions have been made for patients to have take home privileges over the holiday.
(9) That all opioid treatment facilities develop policies and procedures in conjunction with the Board of Pharmacy that will allow access to the Prescription Drug Registry maintained by the Board of Pharmacy within the first month of admission of a patient and at each ninety day treatment review to ensure the patient is not seeking prescription medication from multiple sources.
(k) Other health-related matters which the department is authorized to supervise and for which the rule-making authority has not been otherwise assigned.

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(NOTE: The purpose of this bill is specify certain requirements that are to be included in the legislative rules promulgated by the Department of Health and Human Resources that serve to regulate opioid treatment facilities and to impose a moratorium on the issuance of further certification of need to opioid treatment programs pending a legislative study on the need for and regulation of such opioid treatment programs.

Strike-throughs indicate language that would be stricken from the present law, and underscoring indicates new language that would be added.)

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