H. B. 4321
(By Delegates Rodighiero, Reynolds, Eldridge,
Ellis and Hrutkay)
[Introduced January 29, 2008; referred to the
Committee on Government Organization then the Judiciary.]
A BILL to amend and reenact §16-1-4 of the Code of West Virginia,
1931, as amended, relating to rules by the secretary of public
health, in particular the regulations for opioid treatment
facilities.
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:
ARTICLE 1. STATE PUBLIC HEALTH SYSTEM.
§
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; recordkeeping; 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
Health Care Authority shall develop new certificate of need standards, pursuant to the provisions of article two-d of this
chapter, that are specific for opioid treatment program facilities.
No applications for a certificate of need for opioid treatment
programs shall be approved by the Health Care Authority as of the
effective date of the two thousand seven amendments to this
subsection. The secretary shall promulgate revised emergency rules
to govern licensed 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, which shall
continue until the Legislature determines that there is a necessity
for additional opioid treatment facilities in West Virginia. The
secretary shall file revised emergency rules with the Secretary of
State to regulate opioid programs in compliance with subsections
(1) through (9), inclusive, of this section:
Provided, however,
That any opioid treatment program facility that has received a
certificate of need pursuant to article two-d, of this chapter 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 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 women 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 complete an initial assessment and
an initial plan of care. Subsequently, the opioid treatment
program shall develop a treatment plan of care by the thirtieth day
after admission and attach to the patient's chart no later than
five days after such plan is developed. The treatment plan is to
reflect that detoxification is an option for treatment and
supported by the program.
(3) That each opioid treatment program shall report and
provide statistics to the Department of Health and Human Resources at least semiannually which includes the total number of patients;
the number of patients who have been continually receiving
methadone treatment in excess of two years, including the total
number of months of treatment for each such patient; the state
residency of each patient; the number of patients discharged from
the program, including the total months in the treatment program
prior to discharge and whether the discharge 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 statistically equal chance of being selected for
testing at random and at unscheduled times. Any refusal to
participate in 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) Benzodiazepine 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) (i) Provide mandatory and documented weekly counseling to
the patient, which shall include weekly meetings with a counselor
who is licensed, certified or enrolled in the process of obtaining
licensure or certification in compliance with the rules and on
staff at the opioid treatment program;
(2) (ii) Immediately revoke the take home methadone privilege for a minimum of thirty days; and
(B) Upon a second positive drug test result within six months
of a previous positive drug test result, the opioid treatment
program shall:
(1) (i) Provide mandatory and documented weekly counseling,
which shall include weekly meetings with a counselor who is
licensed, certified or enrolled in the process of obtaining
licensure or certification in compliance with the rules and on
staff at the opioid treatment program;
(2) (ii) Immediately revoke the take-home methadone privilege
for a minimum of sixty days; and
(3) (iii) 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) (i) Provide mandatory and documented weekly counseling,
which shall include weekly meetings with a counselor who is
licensed, certified or enrolled in the process of obtaining
licensure or certification in compliance with the rules and on
staff at the opioid treatment program;
(2) (ii) Immediately revoke the take-home methadone privilege
for a minimum of one hundred twenty days; and
(3) (iii) 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
administered by lottery or some other objective standard so as not
to prejudice or protect any particular patient.
(B) The total number 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.
Provided, That the opioid treatment center
maybe closed for eight holidays and two training days per year.
(9) That the Office of Health Facility Licensure and Certification 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 before
administration of methadone or other treatment in an opioid
treatment program, after any positive drug test, 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.
NOTE: The purpose of this bill is to mandate that opioid
treatment centers remain open seven days a week including holidays
in order to eliminate any methadone being sent home with patients.
Strike-throughs indicate language that would be stricken from
the present law, and underscoring indicates new language that would
be added.