Topics in Health Law: Tennessee Prescription Safety Act of 2012 Creates New Administrative Tasks for Physicians
On March 9, 2012, Governor Haslam signed into law the Tennessee Prescription Safety Act of 2012 (the “Act”). The Act creates new registration, monitoring and reporting requirements for physicians who prescribe or dispense certain controlled substances. Although the full impact of the Act on physicians will not be known until the Department of Health and the Board of Medical Examiners enact applicable rules and regulations, the Act expressly proscribes the following obligations.
Registration Requirements. Beginning January 1, 2013, all physicians and mid-level providers who prescribe or dispense controlled substances for more than 15 days per year must be registered with the Tennessee Controlled Substance Monitoring Database (the “Database”).
Monitoring Requirements. Beginning April 1, 2013, at the beginning of a new treatment episode, physicians must first check the Database before prescribing any opioid or benzodiazepine. If an opioid or benzodiazepine remains part of a patient’s treatment, physicians must check that patient’s Database profile at least once annually. Also, anyone who dispenses controlled substances including physician dispensers, must check the Database prior to dispensing if the dispenser is reasonably certain that the patient is attempting to obtain a Schedule II-V drug for fraudulent, illegal or medically inappropriate purposes. The Act authorizes a newly created controlled substance committee to increase further the list of controlled substances that trigger the Act’s monitoring and reporting requirements.
The Act, however, provides several exemptions to the monitoring requirements. First, the Act permits physicians to delegate the reporting and monitoring duties to another licensed provider (e.g., a nurse), and up to two non-licensed persons. The physician, however, is ultimately responsible for the new requirements. Additionally, controlled substances prescribed or dispensed as a non-refillable prescription as treatment for a surgical procedure that occurred in a licensed healthcare facility do not trigger the requirement. Other exemptions include prescribing or dispensing to patients in hospice care or if the quantity prescribed or dispensed is non-refillable and does not exceed an amount adequate for a single, seven-day treatment period. Finally, certain medical specialties may later be exempted by rulemaking.
Reporting Requirements. For physicians who dispense Schedule II-V controlled substances, current law requires the physician to report certain data to the Database within ten days following the last day of each month. The Act, however, shortens the reporting window to at least once every seven days for all controlled substances dispensed during the preceding seven-day period. The Act also requires submission directly to the Database and increases the data dispensing physicians must submit to include: (i) the date the physician issued the prescription; (ii) whether the prescription was new or a refill; and (iii) the source of payment. Reporting is not required for drugs administered directly to patients, dispensing drug samples, or drugs dispensed by licensed healthcare facilities in a quantity limited to an amount adequate to treat a patient for a maximum of 48 hours. Additionally, under current law, physicians providing services at registered pain management clinics must document in the patient’s record the reason for prescribing or dispensing more than a 72-hour dose of a controlled substance for chronic nonmalignant pain. The Act requires also documenting the reason for the quantity prescribed or dispensed regardless of dosage.
Penalties. As written, the Act authorizes a $100 per day penalty for failure to provide for electronic access to the Database at each practice site where controlled substances are dispensed or prescribed. Anticipated penalties for physicians failing to register, monitor or report, however, have yet to be established by the Board of Medical Examiners. All Tennessee physicians should plan to familiarize themselves with the Board’s rules and regulations once available.