An Act To Adopt the Interstate Prescription Monitoring Program Compact
Be it enacted by the People of the State of Maine as follows:
Sec. 1. 22 MRSA c. 1604 is enacted to read:
CHAPTER 1604
INTERSTATE PRESCRIPTION MONITORING PROGRAM COMPACT
§ 7261. Purpose - Article 1
The purpose of the interstate prescription monitoring program compact, referred to in this chapter as "the compact," is to provide a mechanism for state prescription monitoring programs to securely share prescription data to improve public health and safety. The compact is intended to:
1. Enhance state prescription monitoring programs. Enhance the ability of state prescription monitoring programs, in accordance with state laws, to provide an efficient and comprehensive tool for:
A. Practitioners to monitor patients and support treatment decisions;
B. Law enforcement officials to conduct diversion investigations when authorized by state law;
C. Regulatory agencies to conduct investigations or other appropriate reviews when authorized by state law; and
D. Other uses of prescription drug data authorized by state law for purposes of curtailing drug abuse and diversion; and
2. Provide technology infrastructure. Provide a technology infrastructure to facilitate secure data transmission.
§ 7262. Definitions - Article 2
As used in this chapter, unless the context otherwise indicates, the following terms have the following meanings.
1. Authentication. "Authentication" means the process of verifying the identity and credentials of a person before authorizing access to prescription data.
2. Authorized. "Authorized" means the granting of access privileges to prescription data.
3. Bylaws. "Bylaws" means those bylaws established by the interstate commission pursuant to section 7268 for its governance or for directing or controlling its actions and conduct.
4. Commissioner. "Commissioner" means the voting representative appointed by each member state pursuant to section 7266.
5. Interstate commission or commission. "Interstate commission" or "commission" means the Interstate Prescription Monitoring Program Commission created pursuant to section 7266.
6. Member state. "Member state" means any state that has adopted a prescription monitoring program and has enacted the enabling compact legislation.
7. Practitioner. "Practitioner" means a person licensed, registered or otherwise permitted to prescribe or dispense a prescription drug.
8. Prescription data. "Prescription data" means data transmitted by a prescription monitoring program that contains patient, prescriber, dispenser and prescription drug information.
9. Prescription drug. "Prescription drug" means any drug required to be reported to a state prescription monitoring program and includes but is not limited to substances listed in the federal Controlled Substances Act.
10. Prescription monitoring program. "Prescription monitoring program" means a program that collects, manages, analyzes and provides prescription data under the auspices of a state.
11. Requestor. "Requestor" means a person authorized by a member state who has initiated a request for prescription data.
12. Rule. "Rule" means a written statement by the interstate commission promulgated pursuant to section 7267 that is of general applicability; implements, interprets or prescribes a policy or provision of the compact; or is an organizational, procedural or practice requirement of the commission and has the force and effect of statutory law in a member state. "Rule" includes the amendment, repeal or suspension of an existing rule.
13. State. "State" means any state, commonwealth, district or territory of the United States.
14. Technology infrastructure. "Technology infrastructure" means the design, deployment and use of both individual technology-based components and the systems of such components to facilitate the transmission of information and prescription data among member states.
15. Transmission. "Transmission" means the release, transfer, provision or disclosure of information or prescription data among member states.
§ 7263. Authorized uses and restrictions on prescription data - Article 3
1. Authority of member state. Under the compact a member state:
A. Retains its authority and autonomy over its prescription monitoring program and prescription data in accordance with its laws, rules and policies;
B. May provide, restrict or deny prescription data to a requestor of another state in accordance with the member state's laws, rules and policies;
C. May provide, restrict or deny prescription data received from another state to a requestor within that state; and
D. Has the authority to determine which requestors are authorized.
2. Restrictions on prescription data. Prescription data obtained by a member state pursuant to this compact has the following restrictions.
A. It must be used solely for purposes of providing the prescription data to a requestor.
B. It may not be stored in the member state's prescription monitoring program database, except for stored images, nor in any other database.
3. Limit on categories of requestors. A member state may limit the categories of requestors of another member state that will receive prescription data.
4. Requestor authentication. The commission shall promulgate rules establishing standards for requestor authentication.
A. Every member state shall authenticate requestors according to the rules established by the commission.
B. A member state may authorize its requestors to request prescription data from another member state only after such requestor has been authenticated.
C. A member state that becomes aware of a requestor who violated the laws or rules governing the appropriate use of prescription data shall notify the state that transmitted the prescription data.
§ 7264. Technology and security - Article 4
1. Security requirements. The commission shall establish security requirements through rules for the transmission of prescription data.
2. Open standards for technology infrastructure. The commission shall foster the adoption of open standards for the technology infrastructure that are vendor-neutral and technology-neutral.
3. Acquisition and operation of technology infrastructure. The commission is responsible for acquisition and operation of the technology infrastructure.
§ 7265. Funding - Article 5
1. Interstate commission responsible for funding compact. The interstate commission, through its member states, is responsible for providing for the payment of the reasonable expenses for establishing, organizing and administering the operations and activities of the compact.
2. Interstate commission may collect dues from member states. The interstate commission may levy on and collect annual dues from each member state to cover the cost of operations and activities of the interstate commission and its staff, which must be in a total amount sufficient to cover the interstate commission's annual budget as approved each year. The aggregate annual dues amount must be allocated in an equitable manner and may consist of a fixed fee component as well as a variable fee component based upon a formula to be determined by the interstate commission, which shall promulgate a rule binding upon all member states. Such a formula must take into account factors including but not limited to the total number of practitioners or licensees within a member state. Fees established by the interstate commission may be recalculated and assessed on an annual basis.
3. Interstate commission may accept nonstate funding. Notwithstanding subsections 1 and 2 and any other provision of law, the interstate commission may accept nonstate funding, including grants, awards and contributions to offset, in whole or in part, the costs of the annual dues required under subsection 2.
4. Interstate commission may not incur obligations prior to securing funds. The interstate commission may not incur obligations of any kind prior to securing the funds adequate to meet the same. The interstate commission may not pledge the credit of any of the member states, except by and with the authority of the member states.
5. Interstate commission to keep accurate accounts. The interstate commission shall keep accurate accounts of all receipts and disbursements subject to the audit and accounting procedures established under its bylaws. All receipts and disbursements of funds handled by the interstate commission must be audited annually by a certified or licensed public accountant, and the report of the audit must be included in and become part of the annual report of the interstate commission.
§ 7266. Interstate commission - Article 6
The member states hereby create the Interstate Prescription Monitoring Program Commission to govern the compact. The interstate commission is composed of the member states and not a 3rd-party group or federal agency. The activities of the commission are the formation of public policy and are a discretionary state function.
1. Body corporate. The commission is a body corporate and joint agency of the member states and has all the responsibilities, powers and duties set forth herein and such additional powers as may be conferred upon it by a subsequent concurrent action of the respective legislatures of the member states in accordance with the terms of this compact.
2. Composition. The commission consists of one voting representative from each member state who is that member state's appointed commissioner and who is empowered to determine statewide policy related to matters governed by this compact. The commissioner must be a policy maker within the agency that houses the member state's prescription monitoring program.
3. Nonvoting advisor. In addition to the commissioner, a member state shall appoint a nonvoting advisor who is a representative of the member state's prescription monitoring program.
4. Members of interested organizations. In addition to the voting representatives and nonvoting advisor of each member state, the commission may include persons who are not voting representatives, but who are members of interested organizations as determined by the commission.
5. Each member state entitled to one vote. Each member state represented at a meeting of the commission is entitled to one vote. A majority of the member states constitutes a quorum for the transaction of business, unless a larger quorum is required by the bylaws. A representative may not delegate a vote to another member state. In the event a commissioner is unable to attend a meeting of the commission, the appropriate appointing authority may delegate voting authority to another person from that member state for a specified meeting. The bylaws may provide for meetings of the commission to be conducted by electronic communication.
6. Meetings. The commission shall meet at least once each calendar year. The chair of the commission may call additional meetings and, upon the request of a simple majority of the member states, shall call additional meetings.
7. Executive committee. The commission shall establish an executive committee, which must include officers, members and others as determined by the bylaws. The executive committee has the power to act on behalf of the commission, with the exception of rulemaking. During periods when the commission is not in session the executive committee shall oversee the administration of the compact, including enforcement and compliance with the provisions of the compact, its bylaws and rules, and other such duties as determined necessary.
8. Committee structure. The commission shall maintain a committee structure for governance in areas including but not limited to policy, compliance, education and technology and shall include specific opportunities for stakeholder input.
9. Records available to public. The commission's bylaws and rules must establish conditions and procedures under which the commission shall make its information and official records available to the public for inspection or copying. The commission may exempt from disclosure information or official records that would adversely affect personal privacy rights or proprietary interests.
10. Public notice of meetings; meetings open to public. The commission shall provide public notice of all meetings and all meetings must be open to the public, except as set forth in the rules or as otherwise provided in the compact. The commission may close a meeting, or portion of a meeting, when it determines by a 2/3 vote of the members present that discussions at the open meeting would be likely to:
A. Relate solely to the commission's internal personnel practices and procedures;
B. Concern matters specifically exempted from disclosure by federal and state statute;
C. Concern trade secrets or commercial or financial information that is privileged or confidential;
D. Involve accusing a person of a crime or formally censuring a person;
E. Concern information of a personal nature where disclosure would constitute a clearly unwarranted invasion of personal privacy;
F. Concern investigative records compiled for law enforcement purposes; or
G. Specifically relate to the commission's participation in a civil action or other legal proceeding.
11. Requirements for meeting closed to public. For a meeting or portion of a meeting closed pursuant to subsection 10, the commission's legal counsel or designee shall certify that the meeting may be closed and shall reference each relevant exemptive provision. The commission shall keep minutes that must fully and clearly describe all matters discussed in a meeting and must provide a full and accurate summary of actions taken and the reasons for those actions, including a description of the views expressed and the record of a roll call vote. All documents considered in connection with an action must be identified in these minutes. All minutes and documents of a closed meeting must remain under seal, subject to release by a majority vote of the commission.
§ 7267. Powers and duties of the interstate commission - Article 7
The commission has the following powers and duties:
1. Oversee and maintain technology infrastructure. To oversee and maintain the administration of the technology infrastructure;
2. Promulgate rules; take all necessary actions to effect goals. To promulgate rules and take all necessary actions to effect the goals, purposes and obligations as enumerated in this compact, as long as no member state is required to create an advisory committee. The rules have the force and effect of statutory law and are binding in the member states to the extent and in the manner provided in this compact;
3. Establish process for notification of changes to state law or policies. To establish a process for a member state to notify the commission of changes to that member state's prescription monitoring program statutes, regulations or policies. This subsection applies only to changes that affect the administration of the compact;
4. Issue advisory opinions. To issue, upon request of a member state, advisory opinions concerning the meaning or interpretation of the compact and the commission's bylaws, rules and actions;
5. Enforce compliance with compact provisions. To enforce compliance with the compact provisions, the rules promulgated by the interstate commission and the bylaws, using all necessary and proper means, including but not limited to the use of judicial process;
6. Establish and maintain offices. To establish and maintain one or more offices;
7. Purchase and maintain insurance and bonds. To purchase and maintain insurance and bonds;
8. Provide for personnel or services. To borrow, accept, hire or contract for personnel or services;
9. Establish and appoint committees. To establish and appoint committees including but not limited to an executive committee as required by section 7266, subsection 7;
10. Appoint officers, employees and agents. To elect or appoint officers, attorneys, employees, agents or consultants and to fix their compensation, define their duties and determine their qualifications and to establish the interstate commission's personnel policies and programs relating to conflicts of interest, rates of compensation and qualifications of personnel;
11. Seek and accept donations. To seek and accept donations and grants of money, equipment, supplies, materials and services and to use or dispose of them;
12. Own or lease property. To lease, purchase, accept contributions or donations of or otherwise to own, hold, improve or use any real, personal or mixed property;
13. Sell or exchange property. To sell, convey, mortgage, pledge, lease, exchange, abandon or otherwise dispose of any real, personal or mixed property;
14. Establish budget. To establish a budget and make expenditures;
15. Adopt seal and bylaws. To adopt a seal and bylaws governing the management and operation of the interstate commission;
16. Report. To report annually to the legislatures, governors and attorneys general of the member states concerning the activities of the interstate commission during the preceding year. These reports must also include any recommendations that may have been adopted by the interstate commission and must be made publicly available;
17. Coordinate education. To coordinate education, training and public awareness regarding the compact and its implementation and operation;
18. Maintain books and records. To maintain books and records in accordance with the bylaws;
19. Perform necessary or appropriate functions. To perform such functions as may be necessary or appropriate to achieve the purposes of the compact; and
20. Provide for dispute resolution. To provide for dispute resolution among member states.
§ 7268. Organization and operation of the interstate commission - Article 8
1. Bylaws. The interstate commission shall, by a majority of the members present and voting, within 12 months after the first interstate commission meeting, adopt bylaws to govern its conduct as may be necessary or appropriate to carry out the purposes of the compact, including, but not limited to:
A. Establishing the fiscal year of the interstate commission;
B. Establishing an executive committee and such other committees as may be necessary for governing any general or specific delegation of authority or function of the interstate commission;
C. Providing procedures for calling and conducting meetings of the interstate commission and ensuring reasonable notice of each meeting;
D. Establishing the titles and responsibilities of the officers and staff of the interstate commission; and
E. Providing a mechanism for concluding the operations of the interstate commission and the return of surplus funds that may exist upon the termination of the compact after the payment and reserving of all of its debts and obligations.
2. Officers. The interstate commission shall, by a majority vote of the members present, elect annually from among its members a chair, a vice-chair and a treasurer, each of whom has such authority and duties as may be specified in the bylaws. The chair or, in the chair's absence or disability, the vice-chair shall preside at all meetings of the interstate commission. The officers elected serve without compensation or remuneration from the interstate commission, except that, subject to the availability of budgeted funds, the officers must be reimbursed for ordinary and necessary costs and expenses incurred by them in the performance of their responsibilities as officers of the interstate commission.
3. Executive committee and staff. The following provisions govern the executive committee and staff.
A. The executive committee has such authority and duties as may be set forth in the bylaws, including but not limited to:
(1) Managing the affairs of the interstate commission in a manner consistent with the bylaws and purposes of the interstate commission;
(2) Overseeing an organizational structure within, and appropriate procedures for, the interstate commission to provide for the administration of the compact; and
(3) Planning, implementing and coordinating communications and activities with other state, federal and local government organizations in order to advance the purpose of the interstate commission.
B. The executive committee may, subject to the approval of the interstate commission, appoint or retain an executive director for such period upon terms and conditions and for compensation as the interstate commission may consider appropriate. The executive director serves as secretary to the interstate commission, but is not a member of the interstate commission. The executive director shall hire and supervise other persons as may be authorized by the interstate commission.
4. Liability. The interstate commission's executive director and the commission's employees are immune from suit and liability, either personally or in their official capacity, for a claim for damage to or loss of property or personal injury or other civil liability caused or arising out of or relating to an actual or alleged act, error or omission that occurred or that such person had a reasonable basis for believing occurred within the scope of interstate commission employment, duties or responsibilities, except that such person is not protected from suit or liability for damage, loss, injury or liability caused by the intentional or willful and wanton misconduct of such person.
A. The liability of the interstate commission's executive director and employees or interstate commission representatives, acting within the scope of that person's employment or duties for acts, errors or omissions occurring within the person's state may not exceed the limits of liability set forth under the constitution and laws of that state for state officials, employees and agents. The interstate commission is considered to be an instrumentality of the states for the purposes of any such action. This subsection may not be construed to protect the person from suit or liability for damage, loss, injury or liability caused by the intentional or willful and wanton misconduct of that person.
B. The interstate commission shall defend the executive director and its employees and, subject to the approval of the attorney general or other appropriate legal counsel of the member state represented by an interstate commission representative, shall defend the interstate commission representative in any civil action seeking to impose liability arising out of an actual or alleged act, error or omission that occurred within the scope of interstate commission employment, duties or responsibilities, or that the defendant had a reasonable basis for believing occurred within the scope of interstate commission employment, duties or responsibilities, as long as the actual or alleged act, error or omission did not result from intentional or willful and wanton misconduct on the part of such person.
C. To the extent not covered by the state involved, member state or the interstate commission, the representatives or employees of the interstate commission must be held harmless in the amount of a settlement or judgment, including attorney's fees and costs, obtained against such persons arising out of an actual or alleged act, error or omission that occurred within the scope of interstate commission employment, duties or responsibilities, or that such persons had a reasonable basis for believing occurred within the scope of interstate commission employment, duties or responsibilities, as long as the actual or alleged act, error or omission did not result from intentional or willful and wanton misconduct on the part of such persons.
§ 7269. Rule-making functions of the interstate commission - Article 9
1. Rule-making authority. The interstate commission shall promulgate reasonable rules in order to effectively and efficiently achieve the purposes of this compact. Notwithstanding this subsection, in the event the interstate commission exercises its rule-making authority in a manner that is beyond the scope of the purposes of this compact or the powers granted under this compact, such an action by the interstate commission is invalid and has no force or effect. Any rules promulgated by the commission do not override the State's authority to govern prescription drugs or each member state's prescription monitoring program.
2. Rule-making procedure. Rules must be made pursuant to a rule-making process that substantially conforms to the "Model State Administrative Procedure Act," of 1981 Act, Uniform Laws Annotated, Vol. 15, p. 1 (2000) as amended, as may be appropriate to the operations of the interstate commission.
3. Judicial review. Not later than 30 days after a rule is promulgated, any person may file a petition for judicial review of the rule as long as the filing of such a petition does not stay or otherwise prevent the rule from becoming effective unless the court finds that the petitioner has a substantial likelihood of success. The court shall give deference to the actions of the interstate commission consistent with applicable law and may not find the rule to be unlawful if the rule represents a reasonable exercise of the interstate commission's authority.
§ 7270. Oversight, enforcement and dispute resolution - Article 10
1. Oversight. The following provisions govern the oversight of the compact.
A. The executive, legislative and judicial branches of state government in each member state shall enforce this compact and shall take all actions necessary and appropriate to effectuate the compact's purposes and intent. The provisions of this compact and the rules promulgated under this compact have standing as statutory law but do not override the State's authority to govern prescription drugs or the State's prescription monitoring program.
B. All courts shall take judicial notice of the compact and the rules in any judicial or administrative proceeding in a member state pertaining to the subject matter of this compact that may affect the powers, responsibilities or actions of the interstate commission.
C. The interstate commission is entitled to receive all service of process in any proceeding under paragraph B and has standing to intervene in the proceeding for all purposes. Failure to provide service of process to the interstate commission renders a judgment or order void as to the interstate commission, this compact or promulgated rules.
2. Default, technical assistance, suspension and termination. If the interstate commission determines that a member state has defaulted in the performance of its obligations or responsibilities under this compact or the bylaws or promulgated rules, the interstate commission shall provide written notice to the defaulting state and other member states of the nature of the default, the means of curing the default and any action taken by the interstate commission. The interstate commission shall specify the conditions by which the defaulting state must cure its default. The interstate commission shall provide remedial training and specific technical assistance regarding the default.
A. If the defaulting state fails to cure the default, the defaulting state must be terminated from the compact upon an affirmative vote of a majority of the member states and all rights, privileges and benefits conferred by this compact are terminated from the effective date of termination. A cure of the default does not relieve the defaulting state of obligations or liabilities incurred during the period of the default.
B. Suspension or termination of membership in the compact may be imposed only after all other means of securing compliance have been exhausted. Notice of intent to suspend or terminate must be given by the interstate commission to the governor of the defaulting state, the majority and minority leaders of the defaulting state's legislature and each of the member states.
C. A defaulting state that has been suspended or terminated is responsible for all dues, obligations and liabilities incurred through the effective date of suspension or termination, including obligations the performance of which extends beyond the effective date of suspension or termination.
D. The interstate commission may not bear costs relating to any state that has been found to be in default or that has been suspended or terminated from the compact, unless otherwise mutually agreed upon in writing between the interstate commission and the defaulting state.
E. The defaulting state may appeal the action of the interstate commission by petitioning the United States District Court for the District of Columbia or the federal district where the interstate commission has its principal offices. The prevailing party must be awarded all costs of such litigation including reasonable attorney's fees.
3. Dispute resolution. The following provisions govern dispute resolution.
A. The interstate commission shall attempt, upon the request of a member state, to resolve disputes that are subject to the compact and that may arise among member states.
B. The interstate commission shall promulgate rules providing for both mediation and binding dispute resolution as appropriate.
4. Enforcement. The following provisions govern enforcement of the compact.
A. The interstate commission, in the reasonable exercise of its discretion, shall enforce the provisions and rules of this compact.
B. The interstate commission may, by majority vote of the members, initiate legal action in the United States District Court for the District of Columbia or, at the discretion of the interstate commission, in the federal district where the interstate commission has its principal offices, to enforce compliance with the provisions of the compact and its promulgated rules and bylaws against a member state in default. The relief sought may include both injunctive relief and damages. In the event judicial enforcement is necessary the prevailing party must be awarded all costs of such litigation including reasonable attorney's fees.
C. The remedies in this subsection are not the exclusive remedies of the interstate commission. The interstate commission may avail itself of any other remedies available under state law or the regulation of a profession.
§ 7271. Member states, effective date and amendment - Article 11
1. Eligibility for membership in compact. Any state that has enacted prescription monitoring program legislation through statute or regulation is eligible to become a member state of this compact.
2. Effective upon enactment by at least 6 states. The compact becomes effective and binding upon legislative enactment of the compact into law by no fewer than 6 states. Thereafter it becomes effective and binding on a state upon enactment of the compact into law by that state. The governors of nonmember states or their designees must be invited to participate in the activities of the interstate commission on a nonvoting basis prior to adoption of the compact by all states.
3. Amendments. The interstate commission may propose amendments to the compact for enactment by the member states. An amendment may not become effective and binding upon the interstate commission and the member states until it is enacted into law by unanimous consent of the member states.
§ 7272. Withdrawal and dissolution - Article 12
1. Withdrawal. The following provisions govern withdrawal from the compact.
A. Once effective, the compact continues in force and remains binding upon each member state except that a member state may withdraw from the compact by specifically repealing the statute that enacted the compact into law.
B. Withdrawal from this compact must be by the enactment of a statute repealing the compact, but may not take effect until one year after the effective date of that statute and until written notice of the withdrawal has been given by the withdrawing state to the governor of each other member state.
C. The withdrawing state shall immediately notify the chair of the interstate commission in writing upon the introduction of legislation repealing this compact in the withdrawing state. The interstate commission shall notify the other member states of the withdrawing state's intent to withdraw within 60 days of its receipt of notice.
D. The withdrawing state is responsible for all dues, obligations and liabilities incurred through the effective date of withdrawal, including obligations the performance of which extends beyond the effective date of withdrawal.
E. Reinstatement following withdrawal of a member state occurs upon the withdrawing state's reenacting the compact or upon such later date as determined by the interstate commission.
2. Dissolution of the compact. The following provisions govern dissolution of the compact.
A. This compact dissolves effective upon the date of the withdrawal or default of the member state that reduces the membership in the compact to one member state.
B. Upon the dissolution of this compact, the compact becomes void and is of no further force or effect, and the business and affairs of the interstate commission must be concluded and surplus funds must be distributed in accordance with the bylaws.
§ 7273. Severability and construction - Article 13
1. Severable. The provisions of this compact are severable, and if any phrase, clause, sentence or provision is determined unenforceable, the remaining provisions of the compact are enforceable.
2. Liberally construed. The provisions of this compact must be liberally construed to effectuate its purposes.
3. Concurrent applicability. Nothing in this compact may be construed to prohibit the applicability of other interstate compacts to which the states are members.
§ 7274. Binding effect of compact and other laws - Article 14
1. Other laws. Nothing in this compact prevents the enforcement of any other law of a member state that is not inconsistent with this compact. All member states' laws conflicting with this compact are superseded to the extent of the conflict.
2. Binding effect of compact. All lawful actions of the interstate commission, including all rules and bylaws promulgated by the interstate commission, are binding upon the member states.
A. All agreements between the interstate commission and the member states are binding in accordance with their terms.
B. In the event any provision of this compact exceeds the constitutional limits imposed on the legislature of any member state, the provision is ineffective to the extent of the conflict with the constitutional provision in question in that member state.
Sec. 2. Legislative intent. This Act is the enactment of the interstate prescription monitoring program compact. The text and numbering of the compact have been changed to conform to Maine statutory conventions. The changes are technical in nature and it is the intent of the Legislature that this Act be interpreted as substantively the same as the original compact.
Effective 90 days following adjournment of the 125th Legislature, First Regular Session, unless otherwise indicated.