Bill Text: MI HB4369 | 2011-2012 | 96th Legislature | Chaptered
Bill Title: Health; pharmaceuticals; electronic monitoring system for certain dispensed controlled substances; allow health care payment or benefit providers to access data until date certain and allow department to request access data. Amends sec. 7333a of 1978 PA 368 (MCL 333.7333a).
Spectrum: Slight Partisan Bill (Democrat 14-5)
Status: (Passed) 2012-03-08 - Assigned Pa 44'12 With Immediate Effect [HB4369 Detail]
Download: Michigan-2011-HB4369-Chaptered.html
Act No. 44
Public Acts of 2012
Approved by the Governor
March 6, 2012
Filed with the Secretary of State
March 7, 2012
EFFECTIVE DATE: March 7, 2012
STATE OF MICHIGAN
96TH LEGISLATURE
REGULAR SESSION OF 2012
Introduced by Reps. Liss, Segal, Barnett, Haugh, Ananich, Bauer, Constan, Crawford, Darany, Durhal, Haines, Huuki, Kowall, MacMaster, McCann, Slavens, Smiley and Talabi
ENROLLED HOUSE BILL No. 4369
AN ACT to amend 1978 PA 368, entitled “An act to protect and promote the public health; to codify, revise, consolidate, classify, and add to the laws relating to public health; to provide for the prevention and control of diseases and disabilities; to provide for the classification, administration, regulation, financing, and maintenance of personal, environmental, and other health services and activities; to create or continue, and prescribe the powers and duties of, departments, boards, commissions, councils, committees, task forces, and other agencies; to prescribe the powers and duties of governmental entities and officials; to regulate occupations, facilities, and agencies affecting the public health; to regulate health maintenance organizations and certain third party administrators and insurers; to provide for the imposition of a regulatory fee; to provide for the levy of taxes against certain health facilities or agencies; to promote the efficient and economical delivery of health care services, to provide for the appropriate utilization of health care facilities and services, and to provide for the closure of hospitals or consolidation of hospitals or services; to provide for the collection and use of data and information; to provide for the transfer of property; to provide certain immunity from liability; to regulate and prohibit the sale and offering for sale of drug paraphernalia under certain circumstances; to provide for the implementation of federal law; to provide for penalties and remedies; to provide for sanctions for violations of this act and local ordinances; to provide for an appropriation and supplements; to repeal certain acts and parts of acts; to repeal certain parts of this act; and to repeal certain parts of this act on specific dates,” by amending section 7333a (MCL 333.7333a), as amended by 2011 PA 108.
The People of the State of Michigan enact:
Sec. 7333a. (1) The department shall establish, by rule, an electronic system for monitoring schedule 2, 3, 4, and 5 controlled substances dispensed in this state by veterinarians, and by pharmacists and dispensing prescribers licensed under part 177 or dispensed to an address in this state by a pharmacy licensed in this state. The rules shall provide an appropriate electronic format for the reporting of data including, but not limited to, patient identifiers, the name of the controlled substance dispensed, date of dispensing, quantity dispensed, prescriber, and dispenser. The department shall require a veterinarian, pharmacist, or dispensing prescriber to utilize the electronic data transmittal process developed by the department or the department’s contractor. A veterinarian, pharmacist, or dispensing prescriber shall not be required to pay a new fee dedicated to the operation of the electronic monitoring system and shall not incur any additional costs solely related to the transmission of data to the department. The rules promulgated under this subsection shall exempt both of the following circumstances from the reporting requirements:
(a) The administration of a controlled substance directly to a patient.
(b) The dispensing from a health facility or agency licensed under article 17 of a controlled substance by a dispensing prescriber in a quantity adequate to treat a patient for not more than 48 hours.
(2) Notwithstanding any practitioner-patient privilege, the director of the department may provide data obtained under this section to all of the following:
(a) A designated representative of a board responsible for the licensure, regulation, or discipline of a practitioner, pharmacist, or other person who is authorized to prescribe, administer, or dispense controlled substances.
(b) An employee or agent of the department.
(c) A state, federal, or municipal employee or agent whose duty is to enforce the laws of this state or the United States relating to drugs.
(d) A state-operated medicaid program.
(e) A state, federal, or municipal employee who is the holder of a search warrant or subpoena properly issued for the records.
(f) A practitioner or pharmacist who requests information and certifies that the requested information is for the purpose of providing medical or pharmaceutical treatment to a bona fide current patient.
(g) An individual with whom the department has contracted under subsection (8).
(h) A practitioner or other person who is authorized to prescribe controlled substances for the purpose of determining if prescriptions written by that practitioner or other person have been dispensed.
(i) Until December 31, 2016, the health care payment or benefit provider for the purposes of ensuring patient safety and investigating fraud and abuse.
(3) Except as otherwise provided in this part, information submitted under this section shall be used only for bona fide drug-related criminal investigatory or evidentiary purposes or for the investigatory or evidentiary purposes in connection with the functions of a disciplinary subcommittee or 1 or more of the licensing or registration boards created in article 15.
(4) A person who receives data or any report under subsection (2) containing any patient identifiers of the system from the department shall not provide it to any other person or entity except by order of a court of competent jurisdiction.
(5) Except as otherwise provided in this subsection, reporting under subsection (1) is mandatory for a veterinarian, pharmacist, and dispensing prescriber. However, the department may issue a written waiver of the electronic reporting requirement to a veterinarian, pharmacist, or dispensing prescriber who establishes grounds that he or she is unable to use the electronic monitoring system. The department shall require the applicant for the waiver to report the required information in a manner approved by the department.
(6) In addition to the information required to be reported annually under section 7112(3), the controlled substances advisory commission shall include in the report information on the implementation and effectiveness of the electronic monitoring system.
(7) The department, in consultation with the controlled substances advisory commission, the Michigan board of pharmacy, the Michigan board of medicine, the Michigan board of osteopathic medicine and surgery, the Michigan state police, and appropriate medical professional associations, shall examine the need for and may promulgate rules for the production of a prescription form on paper that minimizes the potential for forgery. The rules shall not include any requirement that sequential numbers, bar codes, or symbols be affixed, printed, or written on a prescription form or that the prescription form be a state produced prescription form. In examining the need for rules for the production of a prescription form on paper that minimizes the potential for forgery, the department shall consider and identify the following:
(a) Cost, benefits, and barriers.
(b) Overall cost-benefit analysis.
(c) Compatibility with the electronic monitoring system required under this section.
(8) The department may enter into 1 or more contractual agreements for the administration of this section.
(9) The department, all law enforcement officers, all officers of the court, and all regulatory agencies and officers, in using the data for investigative or prosecution purposes, shall consider the nature of the prescriber’s and dispenser’s practice and the condition for which the patient is being treated.
(10) The data and any report containing any patient identifiers obtained from the data are not public records and are not subject to the freedom of information act, 1976 PA 442, MCL 15.231 to 15.246.
(11) Beginning February 1, 2013 and through February 1, 2016, the department may issue a written request to a health care payment or benefit provider to determine if the provider has accessed the electronic system as provided in subsection (2)(i) in the previous calendar year and, if so, to determine the number of inquiries the provider made in the previous calendar year and any other information the department requests in relation to the provider’s access to the electronic system. A health care payment or benefit provider shall respond to the written request on or before the March 31 following the request. The department shall collaborate with health care payment or benefit providers to develop a reasonable request and reporting form for use under this subsection.
(12) As used in this section:
(a) “Department” means the department of licensing and regulatory affairs.
(b) “Health care payment or benefit provider” means a person that provides health benefits, coverage, or insurance in this state, including a health insurance company, a nonprofit health care corporation, a health maintenance organization, a multiple employer welfare arrangement, a medicaid contracted health plan, or any other person providing a plan of health benefits, coverage, or insurance subject to state insurance regulation.
This act is ordered to take immediate effect.
Clerk of the House of Representatives
Secretary of the Senate
Approved
Governor
