§ 4281. Legislative intent
The general assembly recognizes the important public health benefits of the legal medical use of controlled substances and also the significant risk to public health that can arise due to the abuse of those substances. It is the intent of this chapter to create the Vermont prescription monitoring system, which will provide an electronic database and reporting system for electronic monitoring of prescriptions for Schedules II, III, and IV controlled substances, as defined in 21 C.F.R. Part 1308, as amended and as may be amended, to promote the public health through enhanced opportunities for treatment for and prevention of abuse of controlled substances, without interfering with the legal medical use of those substances. (Added 2005, No. 205 (Adj. Sess.), § 1.)
§ 4282. Definitions
As used in this chapter:
(1) "Dispenser" shall mean any person who "dispenses" or engages in "dispensing" as those terms are defined in 26 V.S.A. § 2022(5).
(2) "Health care provider" shall mean an individual licensed, certified, or authorized by law to provide professional health care service in this State to an individual during that individual's medical or dental care, treatment, or confinement.
(3) "VPMS" shall mean the Vermont Prescription Monitoring System established under this chapter.
(4) "Delegate" means an individual employed by a health care provider or pharmacy or in the Office of the Chief Medical Examiner and authorized by a health care provider or dispenser or by the Chief Medical Examiner to request information from the VPMS relating to a bona fide current patient of the health care provider or dispenser or to a bona fide investigation or inquiry into an individual's death.
(5) "Department" means the Department of Health.
(6) "Drug diversion investigator" means an employee of the Department of Public Safety whose primary duties include investigations involving violations of laws regarding prescription drugs or the diversion of prescribed controlled substances, and who has completed a training program established by the Department of Health by rule that is designed to ensure that officers have the training necessary to use responsibly and properly any information that they receive from the VPMS.
(7) "Evidence-based" means based on criteria and guidelines that reflect high-quality, cost-effective care. The methodology used to determine such guidelines shall meet recognized standards for systematic evaluation of all available research and shall be free from conflicts of interest. Consideration of the best available scientific evidence does not preclude consideration of experimental or investigational treatment or services under a clinical investigation approved by an institutional review board. (Added 2005, No. 205 (Adj. Sess.), § 1; amended 2013, No. 75, § 6.)
§ 4283. Creation; implementation
(a) The Department shall maintain an electronic database and reporting system for monitoring Schedules II, III, and IV controlled substances, as defined in 21 C.F.R. Part 1308, as amended and as may be amended, that are dispensed within the State of Vermont by a health care provider or dispenser or dispensed to an address within the State by a pharmacy licensed by the Vermont Board of Pharmacy.
(b) As required by the Department, every dispenser who is licensed by the Vermont Board of Pharmacy shall report to the Department in a timely manner data for each controlled substance in Schedules II, III, and IV, as amended and as may be amended, dispensed to a patient within Vermont. Reporting shall not be required for:
(1) a drug administered directly to a patient; or
(2) a drug dispensed by a health care provider at a facility licensed by the Department, provided that the quantity dispensed is limited to an amount adequate to treat the patient for a maximum of 48 hours.
(c) Data for each controlled substance that is dispensed shall include the following:
(1) patient identifier, which may include the patient's name and date of birth;
(2) drug dispensed;
(3) date of dispensing;
(4) quantity and dosage dispensed;
(5) the number of days' supply;
(6) health care provider; and
(d) The data shall be provided in the electronic format defined by the Department. To the extent possible, the format shall not require data entry in excess of that required in the regular course of business. Electronic transmission is not required if a waiver has been granted by the Department to an individual dispenser. The Department shall strive to create VPMS in a manner that will enable real-time transmittal to VPMS and real-time retrieval of information stored in VPMS.
(e) It is not the intention of the Department that a health care provider or a dispenser shall have to pay a fee or tax or purchase hardware or proprietary software required by the Department specifically for the use, establishment, maintenance, or transmission of the data. The Department shall seek grant funds and take any other action within its financial capability to minimize any cost impact to health care providers and dispensers.
(f) The Department shall purge from VPMS all data that is more than six years old.
(g) The Commissioner shall develop and provide advisory notices, which shall make clear that all prescriptions for controlled drugs in Schedules II, III, and IV are entered into a statewide database in order to protect the public. The notices shall be distributed at no cost to dispensers and health care providers who are subject to this chapter.
(h) A dispenser shall be subject to discipline by the Board of Pharmacy or by the applicable licensing entity if the dispenser intentionally fails to comply with the requirements of subsection (b), (c), or (d) of this section. (Added 2005, No. 205 (Adj. Sess.), § 1; amended 2013, No. 75, § 7.)
§ 4284. Protection and disclosure of information
(a) The data collected pursuant to this chapter and all related information and records shall be confidential, except as provided in this chapter, and shall not be subject to the Public Records Act. The Department shall maintain procedures to protect patient privacy, ensure the confidentiality of patient information collected, recorded, transmitted, and maintained, and ensure that information is not disclosed to any person except as provided in this section.
(b)(1) The Department shall provide only the following persons with access to query the VPMS:
(A) a health care provider, dispenser, or delegate who is registered with the VPMS and certifies that the requested information is for the purpose of providing medical or pharmaceutical treatment to a bona fide current patient;
(B) personnel or contractors, as necessary for establishing and maintaining the VPMS;
(C) the Medical Director of the Department of Vermont Health Access, for the purposes of Medicaid quality assurance, utilization, and federal monitoring requirements with respect to Medicaid recipients for whom a Medicaid claim for a Schedule II, III, or IV controlled substance has been submitted;
(D) a medical examiner or delegate from the Office of the Chief Medical Examiner, for the purpose of conducting an investigation or inquiry into the cause, manner, and circumstances of an individual's death;
(E) a health care provider or medical examiner licensed to practice in another state, to the extent necessary to provide appropriate medical care to a Vermont resident or to investigate the death of a Vermont resident.
(2) The Department shall provide reports of data available to the Department through the VPMS only to the following persons:
(A) A patient or that person's health care provider, or both, when VPMS reveals that a patient may be receiving more than a therapeutic amount of one or more regulated substances.
(B) A designated representative of a board responsible for the licensure, regulation, or discipline of health care providers or dispensers pursuant to a bona fide specific investigation.
(C) A patient for whom a prescription is written, insofar as the information relates to that patient.
(D) The relevant occupational licensing or certification authority if the Commissioner reasonably suspects fraudulent or illegal activity by a health care provider. The licensing or certification authority may report the data that are the evidence for the suspected fraudulent or illegal activity to a drug diversion investigator.
(E)(i) The Commissioner of Public Safety, personally, or the Deputy Commissioner of Public Safety, personally, if the Commissioner of Health, personally, or a Deputy Commissioner of Health, personally, makes the disclosure and has consulted with at least one of the patient's health care providers, when the disclosure is necessary to avert a serious and imminent threat to a person or the public.
(ii) The Commissioner of Public Safety, personally, or the Deputy Commissioner of Public Safety, personally, when he or she requests data from the Commissioner of Health, and the Commissioner of Health believes, after consultation with at least one of the patient's health care providers, that disclosure is necessary to avert a serious and imminent threat to a person or the public.
(iii) The Commissioner or Deputy Commissioner of Public Safety may disclose such data received pursuant to this subdivision (E) as is necessary, in his or her discretion, to avert the serious and imminent threat.
(F) A prescription monitoring system or similar entity in another state pursuant to a reciprocal agreement to share prescription monitoring information with the Vermont Department of Health as described in section 4288 of this title.
(c) A person who receives data or a report from VPMS or from the Department shall not share that data or report with any other person or entity not eligible to receive that data pursuant to subsection (b) of this section, except as necessary and consistent with the purpose of the disclosure and in the normal course of business. Nothing shall restrict the right of a patient to share his or her own data.
(d) The Commissioner shall offer health care providers and dispensers training in the proper use of information they may receive from VPMS. Training may be provided in collaboration with professional associations representing health care providers and dispensers.
(e) A drug diversion investigator who may receive information pursuant to this section shall not have access to VPMS except for information provided to the officer by the licensing or certification authority.
(f) The Department is authorized to use information from VPMS for research, trend analysis, and other public health promotion purposes provided that data are aggregated or otherwise de-identified. The Department shall post the results of trend analyses on its website for use by health care providers, dispensers, and the general public. When appropriate, the Department shall send alerts relating to identified trends to health care providers and dispensers by electronic mail.
(g) Following consultation with the Unified Pain Management System Advisory Council and an opportunity for input from stakeholders, the Department shall develop a policy that will enable it to use information from VPMS to determine if individual prescribers and dispensers are using VPMS appropriately.
(h) Following consultation with the Unified Pain Management System Advisory Council and an opportunity for input from stakeholders, the Department shall develop a policy that will enable it to evaluate the prescription of regulated drugs by prescribers.
(i) Knowing disclosure of transmitted data to a person not authorized by subsection (b) of this section, or obtaining information under this section not relating to a bona fide specific investigation, shall be punishable by imprisonment for not more than one year or a fine of not more than $1,000.00, or both, in addition to any penalties under federal law.
(j) All information and correspondence relating to the disclosure of information by the Commissioner to a patient's health care provider pursuant to subdivision (b)(2)(A) of this section shall be confidential and privileged, exempt from public inspection and copying under the Public Records Act, immune from subpoena or other disclosure, and not subject to discovery or introduction into evidence.
(k) Each request for disclosure of data pursuant to subdivision (b)(2)(B) of this section shall document a bona fide specific investigation and shall specify the case number of the investigation. (Added 2005, No. 205 (Adj. Sess.), § 1; amended 2013, No. 75, § 8, eff. Oct. 1, 2013.)
§ 4285. Immunity
A dispenser or health care provider shall be immune from civil, criminal, or administrative liability as a result of any action made in good faith pursuant to and in accordance with this chapter, but nothing in this section shall be construed to establish immunity for the failure to follow standards of professional conduct or the failure to exercise due care in the provision of services. (Added 2005, No. 205 (Adj. Sess.), § 1.)
§ 4286. Expired.
§ 4287. Rulemaking
The Department shall adopt rules for the implementation of VPMS as defined in this chapter consistent with 45 C.F.R. Part 164, as amended and as may be amended, that limit the disclosure to the minimum information necessary for purposes of this act. (Added 2005, No. 205 (Adj. Sess.), § 1; amended 2013, No. 75, § 9.)
§ 4288. Reciprocal agreements
The Department of Health may enter into reciprocal agreements with other states that have prescription monitoring programs so long as access under such agreement is consistent with the privacy, security, and disclosure protections in this chapter. (Added 2013, No. 75, § 10, eff. Oct. 1, 2013.)
§ 4289. Standards and guidelines for health care providers and dispensers
(a) Each professional licensing authority for health care providers shall develop evidence-based standards to guide health care providers in the appropriate prescription of Schedules II, III, and IV controlled substances for treatment of chronic pain and for other medical conditions to be determined by the licensing authority. The standards developed by the licensing authorities shall be consistent with rules adopted by the Department of Health.
(b)(1) Each health care provider who prescribes any Schedule II, III, or IV controlled substances shall register with the VPMS by November 15, 2013.
(2) If the VPMS shows that a patient has filled a prescription for a controlled substance written by a health care provider who is not a registered user of VPMS, the Commissioner of Health shall notify the applicable licensing authority and the provider by mail of the provider's registration requirement pursuant to subdivision (1) of this subsection.
(3) The Commissioner of Health shall develop additional procedures to ensure that all health care providers who prescribe controlled substances are registered in compliance with subdivision (1) of this subsection.
(c) Each dispenser who dispenses any Schedule II, III, or IV controlled substances shall register with the VPMS.
(d) Health care providers shall query the VPMS with respect to an individual patient in the following circumstances:
(1) at least annually for patients who are receiving ongoing treatment with an opioid Schedule II, III, or IV controlled substance;
(2) when starting a patient on a Schedule II, III, or IV controlled substance for nonpalliative long-term pain therapy of 90 days or more;
(3) the first time the provider prescribes an opioid Schedule II, III, or IV controlled substance written to treat chronic pain; and
(4) prior to writing a replacement prescription for a Schedule II, III, or IV controlled substance pursuant to section 4290 of this title.
(e) The Commissioner of Health shall, after consultation with the Unified Pain Management System Advisory Council, adopt rules necessary to effect the purposes of this section. The Commissioner and the Council shall consider additional circumstances under which health care providers should be required to query the VPMS, including whether health care providers should be required to query the VPMS when a patient requests renewal of a prescription for an opioid Schedule II, III, or IV controlled substance written to treat acute pain.
(f) Each professional licensing authority for dispensers shall adopt standards, consistent with rules adopted by the Department of Health under this section, regarding the frequency and circumstances under which its respective licensees shall:
(1) query the VPMS; and
(2) report to the VPMS, which shall be no less than once every seven days.
(g) Each professional licensing authority for health care providers and dispensers shall consider the statutory requirements, rules, and standards adopted pursuant to this section in disciplinary proceedings when determining whether a licensee has complied with the applicable standard of care. (Added 2013, No. 75, § 11.)
§ 4290. Replacement prescriptions and medications
(a) As used in this section, "replacement prescription" means an unscheduled prescription request in the event that the document on which a patient's prescription was written or the patient's prescribed medication is reported to the prescriber as having been lost or stolen.
(b) When a patient or a patient's parent or guardian requests a replacement prescription for a Schedule II, III, or IV controlled substance, the patient's health care provider shall query the VPMS prior to writing the replacement prescription to determine whether the patient may be receiving more than a therapeutic dosage of the controlled substance.
(c) When a health care provider writes a replacement prescription pursuant to this section, the provider shall clearly indicate as much by writing the word "REPLACEMENT" on the face of the prescription. The health care provider shall document the writing of the replacement prescription in the patient's medical record. (Added 2013, No. 75, § 12, eff. Oct. 1, 2013.)