Maryland Legislature Passes Prescription Drug Monitoring Program

Lisa Percy, J.D., Manager
State Legislative and Regulatory Affairs


he Maryland Legislature passed a bill that would direct the Department of Health and Mental Hygiene to establish a prescription drug monitoring program that electronically collects and stores data concerning monitored prescription drugs. Regulations would be adopted that assist health care providers and law enforcement professionals in the identification, treatment and prevention of prescription drug abuse and identification and investigation of unlawful diversion. The rules would identify circumstances under which an authorized recipient may disclose prescription monitoring data.

S.B. 333 would create an Advisory Board on Prescription Drug Monitoring. The board would be composed of 21 members, including four physicians and one nurse practitioner with expertise in pain management and areas of practice involving substance abuse and addiction treatment. The Maryland Society of Anesthesiologists would be consulted with respect to the physician appointment. The board would make recommendations regarding the design and implementation of the program, regulations and the need for additional legislation. Recommendation also would address sources of funding and advances in the field of electronic health records and electronic prescription drug monitoring programs. An interim report would be sent to the general assembly. A multidisciplinary consultation team would assist law enforcement agencies or a local entity that received data from the program in interpreting the data and considering whether such data suggest the need for additional investigation. The team would consider the nature of a prescriber’s or a dispenser’s practice, the patient’s medical condition and other relevant facts.

For each monitored prescription drug dispensed, a dispenser would submit information, such as the patient identifier, prescription drug dispensed, date of dispensing, quantity, prescriber, pharmacy from which the drug was dispensed and prescriber’s code (if available). Unless good cause has been shown and approved that data cannot be submitted electronically, the dispenser would submit data to the program by electronic submission.

Prescription drug monitoring data would be confidential, privileged and not subject to discovery, subpoena or other means of legal compulsion in civil litigation. The program could disclose data to an authorized recipient in connection with the patient’s medical care, dispensing of a monitored prescription drug or furthering an existing bona fide individual investigation. The program also could disclose data after redacting all information that could identify a patient, prescriber, dispenser or other individual. The department and its agent and employees would not be subject to liability arising from inaccuracy of information submitted to the program and the unauthorized use or disclosure of data provided to an authorized recipient. An authorized recipient, acting in good faith, would not be subject to liability arising solely from requesting or receiving (or failing to request or receive) data from the program or acting (or failure to act) on the basis of such data provided by the program.

Any dispenser who knowingly fails to submit required data would be subject to a civil penalty not exceeding $500 for each failure. An authorized recipient who knowingly discloses or uses prescription monitoring data in violation would be guilty of a misdemeanor and on conviction subject to imprisonment not exceeding one year, a fine not exceeding $10,000 or both.

Colorado
Governor Bill Owens signed legislation providing limited criminal immunity for a licensed medical caregiver who provides palliative care to a terminally ill patient with the consent of the patient or patient’s agent. The immunity only applies to the offense of manslaughter and does not apply to civil suits. S.B. 102 does not permit a medical caregiver to assist in the suicide of a terminally ill patient.

Oregon
The Oregon Board of Medical Examiners proposed another set of rules that will be considered again in July. The newest proposal would require accreditation by an appropriate board-recognized national or state organization (i.e., the Joint Commission on Accreditation of Healthcare Organizations, the Accreditation Association for Ambulatory Health Care, the American Association for Accreditation of Ambulatory Surgery Facilities, the American Osteopathic Association, the Institute for Medical Quality or the Oregon Medical Association). Accreditation would be required for facilities that provide procedures or surgery using conscious sedation, deep sedation, major conduction block or general anesthesia. Licensees of the medical board would demonstrate qualifications and competency for the procedures performed by being board-certified, or the governing body of the facility could privilege physicians based on nationally recognized credentialing standards. Practitioners administering deep sedation or anesthesia and/or monitoring the patient would be prohibited from playing an integral role in performing the procedure. At least one physician who is currently trained in advanced resuscitative techniques appropriate for the age group would be present or immediately available with age/size-appropriate equipment until the patient met the discharge criteria. Other medical personnel with direct patient contact would be trained in basic life support, at a minimum. The governing body of the facility would be responsible for providing health care providers who have appropriate education and training for administering moderate sedation/analgesia, deep sedation/analgesia or general anesthesia.

The licensee who performs the surgical procedure and/or anesthetic would evaluate and document the patient’s condition and risks associated with the treatment plan and be satisfied that the procedure is within the scope of practice of the providers and facility’s capabilities. Informed consent would be obtained after a discussion of the risks, benefits and alternatives and documented in the medical record. The patient record would include a separate anesthetic record. The licensee performing the procedure would be responsible for determining that the patient is safe to be discharged from the office. All office personnel would be familiar with a written emergency transfer plan.