WEST virginia Legislature
2016 regular session
Senate Bill 651
By Senator Trump
Referred to the Committee on Health and Human Resources; and then to the Committee on the Judiciary.]
A BILL to amend and reenact §60A-9-4 and §60A-9-5 of the Code of West Virginia, 1931, as amended, all relating to controlled substance monitoring; expanding access to confidential information; requiring information on reports of emergency department overdose visits; authorizing reporting certain information to law enforcement, the Drug Enforcement Administration, licensing boards of the prescribers and dispensers whose activity is called into question; modifying duties of the West Virginia Controlled Substances Monitoring Program Database Review Committee; and imposing duties on licensing agencies having jurisdiction over certain prescribers and dispensers.
Be it enacted by the Legislature of West Virginia:
That §60A-9-4 and §60A-9-5 of the Code of West Virginia, 1931, as amended, be amended and reenacted, all to read as follows:
ARTICLE 9. CONTROLLED SUBSTANCES MONITORING.
§60A-9-4. Required information.
(a) Whenever a medical services provider dispenses a controlled substance listed in Schedule II, III or IV as established under the provisions of 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 under this article, report the following information, as applicable:
(1) The name, address, pharmacy prescription number and Drug Enforcement Administration controlled substance registration number of the dispensing pharmacy or the dispensing physician or dentist;
(2) The full legal 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 written and the date filled;
(7) The number of refills, if any, authorized by the prescription;
(8) If the prescription
being dispensed is being picked up by someone other than the patient on behalf
of the patient, the first name, last name and middle initial, address and birth
date of the person picking up the prescription as set forth on the person=s government-issued photo identification card shall be
retained in either print or electronic form until such time as otherwise
directed by rule promulgated by the board;
(9) The source of payment for the controlled substance dispensed; and
(10) Reports of emergency department overdose visits.
(b) The board 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) Products regulated by the provisions of article ten of this chapter shall be subject to reporting pursuant to the provisions of this article to the extent set forth in said article.
(d) Reporting required by this section is not required for a drug administered directly to a patient by a practitioner. Reporting is, however, required by this section for a drug dispensed to a patient by a practitioner: Provided, That the quantity dispensed may not exceed an amount adequate to treat the patient for a maximum of seventy-two hours with no greater than two seventy-two-hour cycles dispensed in any fifteen-day period of time.
§60A-9-5. Confidentiality; limited access to records; period of retention; no civil liability for required reporting.
(a) (1) (A) The information required by this article to be kept by the board 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:
(i) Inspectors and agents of the board;
(ii) Members of the West Virginia State Police expressly authorized by the Superintendent of the West Virginia State Police to have access to the information;
(iii) Authorized agents of local law-enforcement agencies as members of a federally affiliated drug task force;
(iv) Authorized agents of the federal Drug Enforcement Administration;
(v) Duly authorized agents of the Bureau for Medical Services;
(vi) Duly authorized agents of the Office of the Chief Medical Examiner for use in post-mortem examinations;
(vii) Duly authorized agents of licensing boards of practitioners in this state and other states authorized to prescribe Schedules II, III, and IV controlled substances;
(viii) Prescribing practitioners and pharmacists and persons with an enforceable court order or regulatory agency administrative subpoena; and
(ix) The dean of a medical school or chief medical officer of a hospital, an employee of the medical school, hospital as designated by the dean or chief medical officer and who is working under his or her specific direction, or a physician designee if the hospital has no chief medical officer, if the officer, employee, or designee certifies that the requested information is for the purpose of providing medical or pharmaceutical treatment to a bona fide current or prospective patient of any clinic operated by the medical school or it’s practice plan or of the hospital for assessing and evaluating through the peer review process, the prescribing practices of prescribers who are on the adjunct, volunteer, part time or full time faculty or resident physicians of the medical school or have privileges or are resident physicians at the hospital.
Provided , That (B)
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=s legislative rules,
shall be certified as a West Virginia law-enforcement officer and shall have
successfully completed training approved by the board. All information released
by the board 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 (C) 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
(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, prescribers and dispensers 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 and/or report that information to law enforcement, the Drug Enforcement Administration and/or the licensing board of the prescribers and dispensers whose activity is called into question. Reports made to the licensing boards, and all other reports produced by the board, shall be kept confidential except as otherwise provided in this section. 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 subject to a claim for civil damages or other civil relief for the reporting of information to the board 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 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 shall query
the database monthly based on parameters established by the advisory
committee. The review committee may shall 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
licensing agency having jurisdiction over the applicable prescriber or
dispenser shall review each case referred to them on a monthly basis and shall
report to the Board of Pharmacy the dispensation of each case that was made by
the licensing agency. Each month, the licensing agency shall de-identify the
reports and aggregate them by type of dispensation and make public the number
of reports received and the total number of cases by each type of dispensation.
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 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. 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 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, 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 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 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 modify the state's controlled substance monitoring program. It expands access to confidential information; requires information on reports of emergency department overdose visits; authorizes reporting of certain information to law enforcement, the Drug Enforcement Administration, licensing boards of the prescribers and dispensers whose activity is called into question; modifies duties of the West Virginia Controlled Substances Monitoring Program Database Review Committee; and imposes additional duties on licensing agencies having jurisdiction over certain prescribers and dispensers.
Strike-throughs indicate language that would be stricken from a heading or the present law and underscoring indicates new language that would be added.