H. B. 2327
(By Delegates Swartzmiller, Moye, Sumner, Skaff and Boggs)
[Introduced February 13, 2013; referred to the
Committee on Health and Human Resources then the Judiciary.]
A BILL to amend and reenact §60A-9-5 of the Code of West Virginia,
1931, as amended, relating to adding the county sheriff, or
his or her designee, to those law-enforcement officials who
are granted access to certain confidential pharmaceutical
information relating to the monitoring of certain controlled
substances.
Be it enacted by the Legislature of West Virginia:
That §60A-9-5 of the Code of West Virginia, 1931, as amended,
be amended and reenacted to read as follows:
ARTICLE 9. CONTROLLED SUBSTANCES MONITORING.
§60A-9-5. Confidentiality; limited access to records; period of
retention; no civil liability for required reporting.
(a) (1) The information required by this article to be kept by
the State Board of Pharmacy is confidential and not subject to the
provisions of chapter twenty-nine-b of this code or obtainable as
discovery in civil matters absent a court order 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,
the elected sheriff of each
county or his or her designee,
authorized agents of local
law-enforcement agencies as members of a federally affiliated drug
task force, authorized agents of the federal Drug Enforcement
Administration, duly authorized agents of the Bureau for Medical
Services, duly authorized agents of the Office of the Chief Medical
Examiner for use in post-mortem examinations, duly authorized
agents of licensing boards of practitioners in this state and other
states authorized to prescribe Schedules 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 law-enforcement personnel who have
access to the Controlled Substances Monitoring Program database
shall be granted access in accordance with applicable state laws
and Board of Pharmacy legislative rules, shall be certified as a
West Virginia law-enforcement officer and shall have successfully
completed United States Drug Enforcement Administration Diversion
Training and National Association of Drug Diversion Investigation
Training. 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 or dispense 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: Provided, however,
That the West Virginia Controlled Substances Monitoring Program
Database Review Committee established in subsection (b) of this
section is authorized to query the database to comply with said
subsection.
(2) Subject to the provisions of subdivision (1) of this
subsection, the board shall also review the West Virginia
Controlled Substance Monitoring Program database and issue reports
that identify abnormal or unusual practices of patients who exceed
parameters as determined by the advisory committee established in
this section. The board shall communicate with prescribers and
dispensers to more effectively manage the medications of their
patients in the manner recommended by the advisory committee. All
other reports produced by the board shall be kept confidential.
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, and may be shared
with the West Virginia Department of Health and Human Resources for
those purposes, as long as the identities of persons or entities and any personally identifiable information, including protected
health information, contained therein shall be redacted, scrubbed
or otherwise irreversibly destroyed in a manner that will preserve
the confidential nature of the information. No individual or
entity required to report under section four of this article may be
is 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.
(3) The board shall establish an advisory committee to
develop, implement and recommend parameters to be used in
identifying abnormal or unusual usage patterns of patients in this
state. This advisory committee shall:
(A) Consist of the following members: A physician licensed by
the West Virginia Board of Medicine, a dentist licensed by the West
Virginia Board of Dental Examiners, a physician licensed by the
West Virginia Board of Osteopathy, a licensed physician certified
by the American Board of Pain Medicine, a licensed physician board
certified in medical oncology recommended by the West Virginia
State Medical Association, a licensed physician board certified in
palliative care recommended by the West Virginia Center on End of
Life Care, a pharmacist licensed by the West Virginia Board of
Pharmacy, a licensed physician member of the West Virginia Academy
of Family Physicians, an expert in drug diversion and such other
members as determined by the board.
(B) Recommend parameters to identify abnormal or unusual usage
patterns of controlled substances for patients in order to prepare
reports as requested in accordance with subsection (a), subdivision
(2) of this section.
(C) Make recommendations for training, research and other
areas that are determined by the committee to have the potential to
reduce inappropriate use of prescription drugs in this state,
including, but not limited to, studying issues related to diversion
of controlled substances used for the management of opioid
addiction.
(D) Monitor the ability of medical services providers, health
care facilities, pharmacists and pharmacies to meet the twenty-four
hour reporting requirement for the Controlled Substances Monitoring
Program set forth in section three of this article, and report on
the feasibility of requiring real-time reporting.
(E) Establish outreach programs with local law enforcement to
provide education to local law enforcement on the requirements and
use of the Controlled Substances Monitoring Program database
established in this article.
(b) The Board of Pharmacy shall create a West Virginia
Controlled Substances Monitoring Program Database Review Committee
of individuals consisting of two prosecuting attorneys from West
Virginia counties, two physicians with specialties which require
extensive use of controlled substances and a pharmacist who is trained in the use and abuse of controlled substances. The review
committee may determine that an additional physician who is an
expert in the field under investigation be added to the team when
the facts of a case indicate that the additional expertise is
required. The review committee, working independently, may query
the database based on parameters established by the advisory
committee. The review committee may make determinations on a
case-by-case basis on specific unusual prescribing or dispensing
patterns indicated by outliers in the system or abnormal or unusual
usage patterns of controlled substances by patients which the
review committee has reasonable cause to believe necessitates
further action by law enforcement or the licensing board having
jurisdiction over the prescribers or dispensers under
consideration. The review committee shall also review notices
provided by the chief medical examiner pursuant to subsection (h),
section ten, article twelve, chapter sixty-one of this code and
determine on a case-by-case basis whether a practitioner who
prescribed or dispensed a controlled substance resulting in or
contributing to the drug overdose may have breached professional or
occupational standards or committed a criminal act when prescribing
the controlled substance at issue to the decedent. Only in those
cases in which there is reasonable cause to believe a breach of
professional or occupational standards or a criminal act may have
occurred, the review committee shall notify the appropriate professional licensing agency having jurisdiction over the
applicable prescriber or dispenser and appropriate law-enforcement
agencies and provide pertinent information from the database for
their consideration. The number of cases identified shall be
determined by the review committee based on a number that can be
adequately reviewed by the review committee. The information
obtained and developed may not be shared except as provided in this
article and is not subject to the provisions of chapter twenty-
nine-b of this code or obtainable as discovering in civil matters
absent a court order.
(c) The Board of Pharmacy is responsible for establishing and
providing administrative support for the advisory committee and the
West Virginia Controlled Substances Monitoring Program Database
Review Committee. The advisory committee and the review committee
shall elect a chair by majority vote. Members of the advisory
committee and the review committee may not be compensated in their
capacity as members but shall be reimbursed for reasonable expenses
incurred in the performance of their duties.
(d) The board shall promulgate rules with advice and consent
of the advisory committee, in accordance with the provisions of
article three, chapter twenty-nine-a of this code on or before June
1, 2013. The legislative rules must include, but shall not be
limited to, the following matters: (1) Identifying parameters used
in identifying abnormal or unusual prescribing or dispensing patterns; (2) processing parameters and developing reports of
abnormal or unusual prescribing or dispensing patterns for
patients, practitioners and dispensers; (3) establishing the
information to be contained in reports and the process by which the
reports will be generated and disseminated; and (4) setting up
processes and procedures to ensure that the privacy,
confidentiality, and security of information collected, recorded,
transmitted and maintained by the review committee is not disclosed
except as provided in this section.
(e) All practitioners, as that term is defined in section one
hundred-one, article two of this chapter who prescribe or dispense
schedule II, III or IV controlled substances shall, on or before
July 1, 2011, have online or other form of electronic access to the
West Virginia Controlled Substances Monitoring Program database;
(f) Persons or entities with access to the West Virginia
Controlled Substances Monitoring Program database pursuant to this
section may, pursuant to rules promulgated by the Board of
Pharmacy, delegate appropriate personnel to have access to said
database;
(g) Good faith reliance by a practitioner on information
contained in the West Virginia Controlled Substances Monitoring
Program database in prescribing or dispensing or refusing or
declining to prescribe or dispense a schedule II, III or IV
controlled substance shall constitute is an absolute defense in any civil or criminal action brought due to prescribing or dispensing
or refusing or declining to prescribe or dispense; and
(h) A prescribing or dispensing practitioner may notify law
enforcement of a patient who, in the prescribing or dispensing
practitioner's judgment, may be in violation of section four
hundred ten, article four of this chapter, based on information
obtained and reviewed from the controlled substances monitoring
database. A prescribing or dispensing practitioner who makes a
notification pursuant to this subsection is immune from any civil,
administrative or criminal liability that otherwise might be
incurred or imposed because of the notification if the notification
is made in good faith.
(i) Nothing in the article may be construed to require a
practitioner to access the West Virginia Controlled Substances
Monitoring Program database
except as provided in section five-a of
this article.
(j) The Board of Pharmacy shall provide an annual report on
the West Virginia Controlled Substance Monitoring Program to the
Legislative Oversight Commission on Health and Human Resources
Accountability with recommendations for needed legislation no later
than January 1 of each year.
NOTE: The purpose of this bill is to add the county sheriff,
or his or her designee, to those law-enforcement officials who are
granted access to certain confidential pharmaceutical information to identify unusual or abnormal drug practices.
Strike-throughs indicate language that would be stricken from
the present law, and underscoring indicates new language that would
be added.