Amendment #322 to H4100
Prescription Monitoring Amendment
Mr. Golden of Lowell moves to amend the bill by adding the following section:
"SECTION XXXX. Section 24A of Chapter 94C is hereby amended by striking out section 24A as appearing in the 2010 Official Edition, and inserting in place thereof the following section:
Section 24A. Electronic monitoring of the prescribing and dispensing of controlled substances and certain additional drugs
(a) For the purposes of this section, the following words and phrases shall have the following meanings: “Licensed medical provider”, any person licensed by the Board of Registration in Medicine, or by the Division of Health Professions Licensure within the Department of Public Health, to prescribe substances listed in schedules 2, 3, 4 and 5.
“The Department”, shall mean the Department of Public Health.
“The Program”, shall mean the Massachusetts Prescription Monitoring Program as established by Section 24A of Chapter 94C of the Acts of the Commonwealth.
(b) The Department, not later than 90 days from the effective date of this section, consistent with patient confidentiality requirements under state and federal statutes, and consistent with safeguarding database information from improper access or intrusion including but not limited to cyber access or intrusion, shall:--
(1) Promulgate and adopt simplified rules and procedures for the administration of, registering with, and providing duly authorized access to the Program and its database, and shall post the same on its website.
(2) Encourage enrollment within the Program by licensed medical providers, including by notifying them at their professional offices in writing and by electronic means of the existence of the Program, its purposes, its enrollment and access procedures, and including thereof a copy of this Act.
(3)Report its doings consistent herewith in writing, and filing the same with the Clerks of the House and Senate.
(c) Not later than January 2, 2015, all licensed medical providers shall, as a condition of licensure, be and remain enrolled in the Program.
(d) Medical malpractice insurance providers licensed by the Commonwealth may decline to indemnify for actions brought against a licensed medical provider arising from allegations of improper prescribing of a substance or substances listed in schedule 2, 3, 4, or 5, or of failure or refusal to so prescribe, where the said licensed medical provider failed to consult the concerned patient’s prescription medication history, if any, contained within the Program database maintained by the Department before issuing a prescription or prescriptions for a substance or substances listed in schedules 2, 3, 4 or 5; provided, however, that good-faith reliance by a licensed provider on erroneous or incomplete information contained in said database shall be an affirmative defense in any such action.
(e) The Department shall have authority to enter into contracts with qualified vendors for purposes of discharging its obligations under this Act, said vendors being held to fiduciary standards on behalf of the Department. Preference for the awarding of such contracts shall be to vendors operating within the Commonwealth. No such vendor may, by any manner, delegate or assign its responsibility for Program administration or operation to any sub-contractor or similarly placed person or entity by whatever title or description located or operating outside the United States. Nothing in this section shall act to prohibit the Department from replying to legitimate inquiries from duly licensed physicians or other duly licensed medical providers outside the Commonwealth or the United States who request patient information for the purpose of treating a person in their jurisdiction who is seeking or is in need of medical assistance or treatment.
(f) If a provision of this act or its application to any person or circumstance is held invalid, the invalidity does not affect other provisions or applications of the act that can be given effect without the invalid provision or application, and to this end the provisions of this act are severable.
(g)Paragraphs a, b, e and f shall take effect January 2, 2013.
(h)Paragraphs c and d shall take effect on January 2, 2015.
(i)(1) The department shall establish and maintain an electronic system to monitor the prescribing and dispensing of all schedule II to V, inclusive, controlled substances and certain additional drugs by all professionals licensed to prescribe or dispense such substances. For the purposes of this section, “additional drugs” shall mean substances determined by the department to carry a bona fide potential for abuse.
(2) The department shall enter into reciprocal agreements with other states that have compatible prescription drug monitoring programs to share prescription drug monitoring information among the states.
(j) The requirements of this section shall not apply to the dispensing of controlled substances to inpatients in a hospital.
(k) For the purposes of monitoring the prescribing and dispensing of all schedule II to V, inclusive, controlled substances and additional drugs, as authorized in subsection (a), the department shall promulgate regulations including, but not limited to, (1) a requirement that each pharmacy that delivers a schedule II to V, inclusive, controlled substance or a substance classified as an additional drug by the department to the ultimate user shall submit to the department, by electronic means, information regarding each prescription dispensed for a drug included under subsection (a); and (2) a requirement that each pharmacy collects and reports, for each prescription dispensed for a drug under subsection (a), a customer identification number and other information associated with the customer identification number, as specified by the department. Each pharmacy shall submit the information in accordance with transmission methods and frequency requirements promulgated by the department; provided, however, that the information shall be submitted at least once every 7 days. The department may issue a waiver to a pharmacy that is unable to submit prescription information by electronic means. The waiver shall permit the pharmacy to submit prescription information by other means promulgated by the department; provided, however, that all information required in this section is submitted in this alternative format.
(l) Prescription information submitted to the department under this section shall be confidential and exempt from disclosure under clause Twenty-sixth of section 7 of chapter 4 and chapter 66. The department shall maintain procedures to ensure that the privacy and confidentiality of patients and patient information collected, recorded, transmitted and maintained is not disclosed to persons except as provided for in this chapter.
(m) The department shall review the prescription and dispensing monitoring information. If there is reasonable cause to believe a violation of law or breach of professional standards may have occurred, the department shall notify the appropriate law enforcement or professional licensing, certification or regulatory agency or entity and provide prescription information required for an investigation.
(n) The department shall, upon request, provide data from the prescription monitoring program to the following:--
(1) persons authorized to prescribe or dispense controlled substances, for the purpose of providing medical or pharmaceutical care for their patients;
(2) individuals who request their own prescription monitoring information in accordance with procedures established under chapter 66A;
(3) persons authorized to act on behalf of state boards and regulatory agencies that supervise or regulate a profession that may prescribe controlled substances; provided, however, that the data request is in connection with a bona fide specific controlled substance or additional drug-related investigation;
(4) local, state and federal law enforcement or prosecutorial officials working with the executive office of public safety engaged in the administration, investigation or enforcement of the laws governing prescription drugs; provided, however, that the data request is in connection with a bona fide specific controlled substance or additional drug-related investigation;
(5) personnel of the executive office of health and human services regarding Medicaid program recipients; provided, however that the data request is in connection with a bona fide specific controlled substance or additional drug-related investigation; or
(6) personnel of the United States attorney, office of the attorney general or a district attorney; provided, however, that the data request is in connection with a bona fide specific controlled substance or additional drug related investigation.
(o) The department may, at its initiative, provide data from the prescription monitoring program to practitioners in accordance with section 24.
(p) The department may provide de-identified, aggregate information to a public or private entity for statistical research or educational purposes.
(q) The department may contract with another agency or with a private vendor, as necessary, to ensure the effective operation of the prescription monitoring program. A contractor shall be bound to comply with the provisions regarding confidentiality of prescription information in this section.
(r) The department shall promulgate rules and regulations setting forth the procedures and methods for implementing this section.
(s) The department shall submit an annual report on the effectiveness of the prescription monitoring program with the clerks of the house and senate, the chairs of the joint committee on public health, the chairs of the joint committee on health care financing and the chairs of the joint committee on public safety and homeland security.