Senate Bill No. 426
(By Senators Jenkins, Stollings and Plymale)
[Introduced January 25, 2012; referred to the Committee on Health and Human Resources; and then to the Committee on the Judiciary.]
A BILL to amend and reenact §60A-9-3, §60A-9-4 and §60A-9-5 of the Code of West Virginia, 1931, as amended, all relating to controlled substances monitoring; decreasing time period for filing required information; adding data regarding method of payment for prescriptions and identification of person receiving the prescription if other than person for whom prescription is written to required information; and providing a good-faith defense to practitioners for reporting reasonable suspicion of illegal activity to law enforcement in reliance on information contained in database.
Be it enacted by the Legislature of West Virginia:
That §60A-9-3, §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-9-3. Reporting system requirements; implementation; central repository requirement.
(a) On or before September 1, 2002, the Board of Pharmacy shall implement a program wherein a central repository is established and maintained which shall contain such information as is required by the provisions of this article regarding Schedule II, III and IV controlled substance prescriptions written or filled in this state. In implementing this program, the Board of Pharmacy shall consult with the West Virginia State Police, the licensing boards of practitioners affected by this article and affected practitioners.
(b) The program authorized by subsection (a) of this section shall be designed to minimize inconvenience to patients, prescribing practitioners and pharmacists while effectuating the collection and storage of the required information. The State Board of Pharmacy shall allow reporting of the required information by electronic data transfer where feasible, and where not feasible, on reporting forms promulgated by the Board of Pharmacy. The information required to be submitted by the provisions of this article shall be required to be filed no more frequently than once a week within twenty-four hours.
(c)(1) The State Board of Pharmacy shall provide for the electronic transmission of the information required to be provided by this article by and through the use of a toll-free telephone line.
(2) A dispenser, who does not have an automated recordkeeping system capable of producing an electronic report in the established format may request a waiver from electronic reporting. The request for a waiver shall be made to the State Board of Pharmacy in writing and shall be granted if the dispenser agrees in writing to report the data by submitting a completed “Pharmacy Universal Claim Form” as defined by legislative rule.
§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 of pharmacy 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;
(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;
(8) The method of payment for the prescription; and
(9) The name and address of the person receiving the prescription if other than the individual for whom the prescription was written.
(b) 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) 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 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.
§60A-9-5. Confidentiality; limited access to records; period of retention; no civil liability for required reporting.
(a) 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 as a member of a 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 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;
(b) 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) 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) 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 or reporting to law enforcement reasonable suspicion of illegal activity shall constitutes an absolute defense in any civil or criminal action brought due to prescribing or dispensing or refusing or declining to prescribe or dispense or reporting to law enforcement reasonable suspicion of illegal activity; 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.
(f) Nothing in the article shall be construed to require a practitioner to access the West Virginia Controlled Substances Monitoring Program database.
NOTE: The purpose of this bill is to decrease the time period for filing ‘required information’; to add data regarding method of payment for prescriptions and identification of person receiving the prescription if other than person for whom prescription is written to ‘required information’; and to provide a good faith defense to practitioners for reporting reasonable suspicion of illegal activity to law enforcement in reliance on information contained in database.
Strike-throughs indicate language that would be stricken from the present law, and underscoring indicates new language that would be added.