H. B. 4471
(By Delegates Manypenny, Swartzmiller, D. Poling,
Caputo, Frazier, Moore, Morgan,
Barill, Moye and Sumner)
[Introduced February 9, 2012; 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 the controlled substances monitoring generally; permitting specific law-enforcement officials who are members of federally affiliated drug task forces access to certain confidential pharmaceutical information to identify unusual prescription drug behavior; requiring the State Board of Pharmacy to issue reports to certain law-enforcement officials, licensing authorities and prescribers that identify abnormal prescription practices; establishing an advisory committee to recommend the parameters of abnormal prescribing patterns and to recommend other actions that could reduce the amount of misuse of prescription drugs; establishing a felony offense for misusing information from the controlled substance database; requiring the Board of Pharmacy to implement a real-time database when available and when resources permit; requiring implementation of the parameters of abnormal prescribing patterns shall be contingent on available funding; requiring a report to the Legislative Oversight Commission on Health and Human Resources Accountability; granting rule-making authority; and providing immunity to prescribing practitioners for certain reporting based on review of patient specific information contained in the controlled substances monitoring database.
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 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 deputy sheriffs as a member of a federally affiliated drug task force, authorized agents of the federal Drug Enforcement Administration, duly authorized agents of the Bureau for Medical Services and the Workers’ Compensation Commission, 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 database shall be granted access in accordance with applicable state laws and Board of Pharmacy legislative rules and shall be certified as a West Virginia law-enforcement officer and shall have successfully completed U. S. Drug Enforcement Administration Diversion Training and National Association of Drug Diversion Investigation Training. Provided, That all 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.
(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 both health care professionals and patients who exceed predetermined parameters. All reports produced by the board shall be kept confidential and may only be used in furtherance of communicating with licensing boards regarding abnormal prescription and dispensing practices or by prescribers to more effectively manage the medications of their patients. 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.
(3) The board shall establish an advisory committee to develop, implement and recommend parameters to be used in identifying abnormal or unusual prescribing or dispensing patterns in this state. This advisory committee shall:
(A) Consist of the following members: A licensed physician member of the West Virginia Board of Medicine, a licensed dentist member of the West Virginia Board of Dental Examiners, a licensed physician member of the West Virginia Board of Osteopathy, a member of the Controlled Substance Advisory Board of the Partnership for Community Well-being, a licensed physician certified by the American Board of Pain Medicine and 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 member of the West Virginia Board of Pharmacy, a licensed physician member of the West Virginia Academy of Family Practice Physicians and a representative of a controlled substance wholesaler chosen by the Board of Pharmacy.
(B) Recommend parameters to identify abnormal or unusual prescribing or dispensing patterns of use of controlled substances for both patients and health care professionals in order to prepare reports as requested in accordance with subsection (a), subdivision (2) of this section.
(C) Recommend parameters unique to different health care professionals due to the nature of their work such as palliative care physicians, oncologists, and pain medicine specialists.
(D) 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.
(b) Upon receipt of the committee's recommendations of parameters for prescribing and dispensing specific to each profession and subspecialty therewithin, each professional licensing board shall adopt parameters for the profession and subspecialties thereof and provide them to the board.
(c) The Board of Pharmacy is responsible for establishing the advisory committee and providing administrative support. The advisory committee shall elect a chair by majority vote. 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, 2012. The legislative rules must include, but 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 both patients and health care professionals; and (3) establishing the information to be contained in reports and the process by which the reports will be generated and disseminated.
(b) (d) 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;
(c) (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;
(d) (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; and
(e) The Board of Pharmacy is hereby authorized to promulgate an emergency rule under chapter twenty-nine-a to effectuate the amendments to this section enacted during the 2010 Regular Session of the Legislature.
(g) A prescribing practitioner may notify law enforcement of a patient, who in the prescribing practitioner’s judgment may be in violation of section four hundred ten, article four, chapter sixty-a of this code, based on information obtained and reviewed from the controlled substances monitoring database. A prescribing practitioner who makes a notification pursuant to this subsection shall be immune from any civil, administrative or criminal liability that otherwise might be incurred or imposed because of such notification if such notification is made in good faith.
(f) (h) Nothing in the article shall be construed to requirea a practitioner to access the West Virginia Controlled Substances Monitoring Program database.
(i) Unauthorized access or use or unauthorized disclosure of the information in the database is a felony punishable by incarceration in a state correctional facility for not less than one year nor more than five years or fined not less than $3,000 nor more than $10,000, or both.
(j) The Board of Pharmacy shall make every effort to update the database to a real-time database as soon as a system is available and when funding is available. The implementation of the parameters to identify abnormal or unusual prescribing or dispensing patterns or practices as established by this article shall be contingent on available funding.
(k) 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.
NOTE: The purpose of this bill is to permit specific law- enforcement officials access to certain confidential pharmaceutical information to identify unusual or abnormal prescription drug behavior.
Strike-throughs indicate language that would be stricken from the present law, and underscoring indicates new language that would be added.