H. B. 4387
(By Delegates Michael, Perdue, Leach,
Foster, Long and Hall)
[Introduced
February 10, 2004
; referred to the
Committee on Health and Human Resources then the Judiciary.]
A BILL to amend and reenact §16-1-4 of the code of West Virginia,
1931, as amended; and to amend and reenact §60A-9-4 and
§60A-9-5 of said code, all relating to a proposal of rules by
the secretary; requiring the promulgation of emergency rules
for methadone treatment facilities; and requiring methadone
treatment facilities to participate in the controlled
substance monitoring program.
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; and that §60A-9-4 and §60A-9-5 of said
code be amended and reenacted, all 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 the 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; and
(j) The regulation of methadone treatment facilities duly
licensed and operating under the requirements of chapter
twenty-seven of this code. These rules shall include, but not be
limited to, standards of operation of these facilities, staff
qualifications, staff and patient ratios, a continuum of care plan,
required drug testing for participants and assessment of fines and
penalties for noncompliance. The secretary shall promulgate
emergency rules to govern such facilities by the first day of July,
two thousand four. All existing methadone treatment facilities
shall be in compliance within one hundred eighty days of the effective date of this rule.
(j) (k) Other health-related matters
which the department is
authorized to supervise and for which the rule-making authority has
not been otherwise assigned.
ARTICLE 9. CONTROLLED SUBSTANCES MONITORING.
§60A-9-4. Required information.
(a) Whenever a medical services provider dispenses a
controlled substance listed in the provisions of section two
hundred six, article two of this chapter, or whenever a
prescription for the controlled substance is filled by: (i) A
pharmacist or pharmacy in this state; (ii) a hospital, or other
health care facility, for out-patient use; or (iii) a pharmacy or
pharmacist, licensed by the board of pharmacy, but situated outside
this state for delivery to a person residing in this state, the
medical services provider, health care facility, pharmacist or
pharmacy shall, in a manner prescribed by rules promulgated by the
board of pharmacy under this article, report the following
information, as applicable:
(1) The name, address, pharmacy prescription number and DEA
controlled substance registration number of the
medical services
provider, health care facility, pharmacist or dispensing pharmacy;
(2) The name, address and birth date of the person for whom
the prescription is written;
(3) The name, address and drug enforcement administration
controlled substances registration number of the practitioner
writing the prescription;
(4) The name and national drug code number of the Schedule II,
III and IV controlled substance dispensed;
(5) The quantity and dosage of the Schedule II, III and IV
controlled substance dispensed;
(6) The date the prescription was filled; and
(7) The number of refills, if any, authorized by the
prescription.
(b)
Opioid treatment centers which administer or dispense
methadone shall, in a manner prescribed by rules promulgated by the
board of pharmacy, report the following:
(1) The name, address and birth date of all participants in
the opioid treatment program with the date of entering the program
and, upon completion of the program with the date of exiting the
program;
(2) The name, address and drug enforcement administration
controlled substance registration number of the practitioner
writing orders to the participant population generally; and
(3) The name and national drug code number of the drug being
administered.
(b) (c) The board of pharmacy may prescribe by rule
promulgated under this article the form to be used in prescribing
a Schedule II, III and IV substance if, in the determination of the
board, the administration of the requirements of this section would
be facilitated.
(c) (d) Reporting required by this section is not required for
a drug administered directly to a patient or a drug dispensed by a practitioner at a facility licensed by the state:
Provided, That
the quantity dispensed is limited to an amount adequate to treat
the patient for a maximum of seventy-two hours with no greater than
two seventy-two hour cycles in any fifteen day period of time:
Provided, That opioid treatment centers are required to report as
established in this article.
§60A-9-5. Confidentiality; limited access to records; period of
retention; no civil liability for required reporting.
The information required by this article to be kept by the
state board of pharmacy is confidential and is open to inspection
only by inspectors and agents of the state board of pharmacy,
members of the West Virginia state police expressly authorized by
the superintendent of the West Virginia state police, to have
access to the information,
authorized agents of local
law-enforcement agencies and drug task forces, authorized agents of
the federal drug enforcement agency, duly authorized agents of
licensing boards of practitioners in this state and other states
authorized to prescribe Schedule II, III and IV controlled
substances, prescribing practitioners and pharmacists and persons
with an enforceable court order or regulatory agency administrative
subpoena:
Provided, That all information released by the state
board of pharmacy must be related to a specific patient or a
specific individual or entity under investigation by any of the
above parties except that practitioners who prescribe controlled
substances may request specific data related to their drug
enforcement administration controlled substance registration number or for the purpose of providing treatment to a patient. The board
shall maintain the information required by this article for a
period of not less than five years. Notwithstanding any other
provisions of this code to the contrary, data obtained under the
provisions of this article may be used for compilation of
educational, scholarly or statistical purposes as long as the
identities of persons or entities remain confidential. No
individual or entity required to report under section four of this
article may be subject to a claim for civil damages or other civil
relief for the reporting of information to the board of pharmacy as
required under and in accordance with the provisions of this
article.
NOTE: The purpose of this bill is to require reporting by
methadone clinics to the controlled substance monitoring program
housing in the Board of Pharmacy and require the Department of
Health and Human Resources to promulgate emergency rules for
methadone treatment centers by the first of September, 2004.
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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