WEST virginia Legislature
2018 regular session
Introduced
Senate Bill 65
By Senators Weld, Cline, and Takubo
[Introduced January
10, 2018; Referred
to the Committee on Health and Human Resources; and then to the Committee on
the Judiciary]
A BILL to amend and reenact §60A-9-5 of the Code of West Virginia, 1931, as amended, relating to access to controlled substance monitoring information.
Be it enacted by the Legislature of West Virginia:
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 Board of Pharmacy is confidential and not subject to the
provisions of §29B-1-1 et seq. 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 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 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 the Office of Health Facility Licensure and
Certification for use in certification, licensure and regulation of health
facilities, 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, a dean of any
medical school or his or her designee located in this state to access
prescriber level data to monitor prescribing practices of faculty members,
prescribers and residents enrolled in a degree program at the school where he
or she serves as dean, a physician reviewer designated by an employer of
medical providers to monitor prescriber level information of prescribing
practices of physicians, advance practice registered nurses or physician
assistant in their employ, and a chief medical officer of a hospital or a
physician designated by the chief executive officer of a hospital who does not
have a chief medical officer, for prescribers who have admitting privileges to
the hospital or prescriber level information, and persons with an enforceable
court order or regulatory agency administrative subpoena. 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 the
Board of Pharmacy’s rules, shall be certified as a West Virginia
law-enforcement officer and shall have successfully completed training approved
by the Board of Pharmacy. All information released by the 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,
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 that subsection.
(2) Notwithstanding the provisions of subdivision (1) of this subsection, upon receipt of a request from a medical director or a pharmacy director of a managed care organization that has entered into a contract with the Department of Health and Human Resources under §9-2-6(5) of this code, the board shall provide to the medical director or the pharmacy director information from the database relating to a Medicaid recipient enrolled in the managed care organization, including information in the database related to prescriptions for the recipient that were not covered or reimbursed under a program administered by the Bureau for Medical Services: Provided, That the board may promulgate rules to safeguard information relating to Medicaid recipients enrolled in Medicaid provided to managed care organizations under this subsection.
(2) (3)
Subject to the provisions of subdivision
(1) of this subsection, the Board of Pharmacy 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
of Pharmacy shall communicate with practitioners 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 of Pharmacy
shall be kept confidential. The Board of Pharmacy 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 §60A-9-4 of this code 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.
(3) (4)
The Board of Pharmacy 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 Osteopathic Medicine, 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 of Pharmacy.
(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 subdivision (2) of this subsection.
(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 24-hour reporting requirement for the Controlled Substances Monitoring Program set forth in §60A-9-3 of this code, 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 practitioners
or dispensers under consideration. The licensing board having jurisdiction over
the practitioner or dispenser under consideration shall report back to the
Board of Pharmacy regarding any findings, investigation or discipline resulting
from the findings of the review committee within thirty days of resolution of
any action taken by the licensing board resulting from the information provided
by the Board of Pharmacy. The review committee shall also review notices
provided by the chief medical examiner pursuant to §61-12-10(h) 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 practitioner 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 §29B-1-1 et seq. 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 of Pharmacy shall promulgate rules with advice and consent of the advisory committee, in accordance with the provisions of §29A-3-1 et seq. of this code. 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) 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.
(f) 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 an absolute defense in any civil or criminal action brought due to prescribing or dispensing or refusing or declining to prescribe or dispense.
(g) 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 §60A-4-410 of this code, 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.
(h) 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 §60A-9-5a of this code.
(i) 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 permit managed care organizations to access controlled substances database information for individuals enrolled in the managed care organization’s Medicaid plan.
Strike-throughs indicate language that would be stricken from a heading or the present law and underscoring indicates new language that would be added.