1 0 Page of S. Introduced by Senator Sears Referred to Committee on Date: Subject: Health; prescription drugs; Vermont Prescription Monitoring System Statement of purpose of bill as introduced: This bill proposes to require that a person provide identification prior to receiving a prescription drugfrom a pharmacy; allow a patient to possess an amount of regulated drugsof not more than seven days individual prescribed dosage, for personal use, outside its lawful container; require the Department of Public Safety to adopt 0standard operating guidelines for accessing pharmacy records; require health care providers to search the Vermont Prescription Monitoring System (VPMS) prior to prescribing a controlled substance; expand the categories of persons who may access the VPMS; reestablish the VPMS Advisory Committee; establish an unused drug disposal program; and create a track and trace pilot program for buprenorphine. An act relating to the Vermont Prescription Monitoring System It is hereby enacted by the General Assembly of the State of Vermont:
2 0 Page of 0 Sec.. PURPOSE It is the purpose of this act to maximize the effectiveness and appropriate utilization of the Vermont Prescription Monitoring System, which serves as an important tool in promoting public health by providing opportunities for treatment for and prevention of abuse of controlled substances without interfering with the legal medical use of those substances. Sec.. V.S.A. 0 is amended to read: 0. DEFINITIONS As used in this chapter, unless the context otherwise requires: * * * () Prescription means an order for a regulated drug made by a physician, advanced practice registered nurse, dentist, or veterinarian licensed under this chapter to prescribe such a drug which shall be in writing except as otherwise specified herein in this subdivision. Prescriptions for such drugs shall be made to the order of an individual patient, dated as of the day of issue, and signed by the prescriber. The prescription shall bear the full name and, address, and date of birth of the patient, or if the patient is an animal, the name and address of the owner of the animal and the species of the animal. Such 0 prescription shall also bear the full name, address, and registry number of the prescriber and shall be written with ink, indelible pencil, or typewriter; if typewritten, it shall be signed by the physician prescriber. A written or
3 0 Page of 0 0 typewritten prescription for a controlled substance, as defined in C.F.R. Part 0, shall contain the quantity of the drug written both in numeric and word form. * * * Sec.. V.S.A. b is added to read: b. IDENTIFICATION Prior to dispensing a prescription for a Schedule II, III, or IV controlled substance, a pharmacist shall require the individual receiving the drug to provide a signature and show valid and current government-issued photographic identification as evidence that the individual is the patient for whom the prescription was written, the owner of the animal for which the prescription was written, or the bona fide representative of the patient or animal owner. If the individual does not have valid, current government-issued photographic identification, the pharmacist may request alternative evidence of the individual s identity, as appropriate. Sec.. V.S.A. is amended to read:. AUTHORIZED POSSESSION BY INDIVIDUALS (a) A person to whom or for whose use any regulated drug has been prescribed, sold, or dispensed, and the owner of any animal for which any such drug has been prescribed, sold, or dispensed, may lawfully possess the same on the condition that such drug was prescribed, sold, or dispensed by a physician,
4 0 Page of 0 0 dentist, pharmacist, or veterinarian licensed under this chapter or under the laws of another state or country wherein such person has his or her practice, and further that all. (b)() Except as otherwise provided in subdivision () of this subsection, all amounts of the drug are shall be retained in the lawful container in which it was delivered to him the patient by the person selling or dispensing the same, provided however, that for the purposes of this section an amount of regulated drugs of not more than two days individual prescribed dosage may be possessed by a patient for his personal use drug. () A patient may possess an amount of regulated drugs of not more than seven days individual prescribed dosage, for personal use, which shall not be required to be retained in its lawful container. A patient may possess an amount of regulated drugs of more than seven days individual prescribed dosage, for personal use, which shall not be required to be retained in its lawful container, provided the patient personally possesses proof of a lawful, written prescription. Sec.. V.S.A. is amended to read:. ENFORCEMENT (a) It is hereby made the duty of the department of public safety Department of Public Safety, its officers, agents, inspectors, and representatives, and pursuant to its specific authorization any other peace
5 0 Page of officer within the state State, and of all state s attorneys, to enforce all provisions of this chapter and of the rules and regulations of the board of health Board of Health adopted under this chapter, except those otherwise specifically delegated, and to cooperate with all agencies charged with the enforcement of the federal drug laws, this chapter, and the laws ofother states relating to regulated drugs. (b) Such authorities and their specifically authorized agents shall have, at all times, access to all orders, prescriptions, and records kept or maintained 0 under this chapter, as provided herein. (c) A person who gives information to law enforcement officers, the drug rehabilitation commission Drug Rehabilitation Commission, or professional boards as defined in section 0 of this title and their specifically authorized agents, concerning the use of regulated drugs or the misuse by other persons of regulated drugs, shall not be subject to any civil, criminal, or administrative 0 liability or penalty for giving such information. (d) Nothing in this section shall authorize the department of public safety Department of Public Safety and other authorities described in subsection (a) of this section to have access to VPMS (Vermont prescription monitoring system Vermont Prescription Monitoring System) created pursuant to chapter A of this title, except as provided in that chapter.
6 0 Page of (e) The Department of Public Safety shall adopt standard operating guidelines for accessing pharmacy records through the authority granted in this section. Any person authorized to access pharmacy records pursuant to subsection (a) of this section shall follow the Department of Public Safety s guidelines. These guidelines shall be a public record. Sec.. DEPARTMENT OF PUBLIC SAFETY; REPORTING STANDARD 0 0 OPERATING GUIDELINES No later than December, 0, the Commissioner of Public Safety shall submit to the House and Senate Committees on Judiciary, the House Committee on Human Services, and the Senate Committee on Health and Welfare the Department s written standard operating guidelines used to access pharmacy records at individual pharmacies pursuant to V.S.A.. Subsequently, if the guidelines are substantively amended by the Department, it shall submit the amended guidelines to the same committees as soon as practicable. Sec.. V.S.A. is amended to read:. DEFINITIONS As used in this chapter: * * * () Delegate means an individual employed by a health care facility or pharmacy or in the Office of the Chief Medical Examiner and authorized by a
7 0 Page of 0 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. () Department means the Department of Health. () 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. () 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.
8 0 Page of Sec.. V.S.A. is amended to read:. CREATION; IMPLEMENTATION (a) Contingent upon the receipt of funding, the The Department may establish shall maintain an electronic database and reporting system for monitoring Schedules II, III, and IV controlled substances, as defined in 0 C.F.R. Part 0 C.F.R. part 0 (federal schedules of controlled substances), as amended and as may be amended, that are dispensed within the state State of Vermont by a health care provider or dispenser or dispensed to an address within the state State by a pharmacy licensed by the Vermont board of pharmacy Vermont Board of Pharmacy. * * * (e) It is not the intention of the department 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 Department specifically for the use, establishment, maintenance, or transmission of the data. The department 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. * * *
9 0 Page of Sec.. V.S.A. is amended to read:. 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 public records law. The department 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 0 this section. (b)() The department Department shall be authorized to provide data to only provide only the following persons with access to query the VPMS: () 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. ()(A) A health care provider or, dispenser, or delegate who requests information is registered with the VPMS and certifies that the requested information is for the purpose of providing medical or pharmaceutical 0 treatment to a bona fide current patient. (B) Personnel or contractors, as necessary for establishing and maintaining the VPMS.
10 0 Page 0 of 0 (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. () 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 0 pursuant to a bona fide specific investigation. ()(C) A patient for whom a prescription is written, insofar as the information relates to that patient.
11 0 Page of ()(D) The relevant occupational licensing or certification authority if the commissioner 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 trained law enforcement officer drug diversion investigator. ()(E)(i) The commissioner Commissioner of Public Safety, personally, or the Deputy Commissioner of public safety Public Safety, personally, if the commissioner of health Commissioner of Health, personally, or the Deputy Commissioner for Alcohol and Drug Abuse Programs, personally, makes the disclosure, has consulted with at least one of the patient s health care 0 providers, and believes that the disclosure is necessary to avert a serious and 0 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. The Commissioner or Deputy Commissioner of Public Safety may disclose data received pursuant to this subdivision (E) as is necessary, in his or her discretion, to avert the serious and imminent threat. (F) A drug diversion investigator.
12 0 Page of (G) 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 of this title. () Personnel or contractors, as necessary for establishing and maintaining the VPMS. (c) A person who receives data or a report from VPMS or from the department 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 0 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 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 0 associations representing health care providers and dispensers. (e) A trained law enforcement officer 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. [Deleted.] (f) The department Department is authorized to use information from VPMS for research, trend analysis, and other public health promotion purposes
13 0 Page of 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) 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 $,000.00, 0 or both, in addition to any penalties under federal law. (h) All information and correspondence relating to the disclosure of information by the Commissioner to a patient s health care provider pursuant to subdivision (b)()(a) of this section shall be confidential and privileged, exempt from the public access to records law, immune from subpoena or other disclosure, and not subject to discovery or introduction into evidence. (i) Each request for disclosure of data pursuant to subdivision (b)()(b) of this section shall document a bona fide specific investigation and shall specify the name of the person who is the subject of the investigation.
14 0 Page of 0 0 Sec. 0. V.S.A. is amended to read:. RULEMAKING The department Department shall adopt rules for the implementation of VPMS as defined in this chapter consistent with C.F.R. Part C.F.R. part, as amended and as may be amended, that limit the disclosure to the minimum information necessary for purposes of this act and shall keep the senate and house committees on judiciary, the senate committee on health and welfare, and the house committee on human services advised of the substance and progress of initial rulemaking pursuant to this section. Sec.. V.S.A. is added to read:. 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. Sec.. V.S.A. is added to read:. 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
15 0 Page of 0 0 treatment of chronic pain and for other medical conditions to be determined by the licensing authority. (b)() Each health care provider who prescribes any Schedule II, III, or IV controlled substances shall register with the VPMS. () 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 such provider by mail of the provider s registration requirement pursuant to subdivision () of this subsection. () 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 () of this subsection. (c) Each dispenser who dispenses any Schedule II, III, or IV controlled substances shall register with the VPMS. (d)() Each professional licensing authority for health care providers and dispensers authorized to prescribe or dispense Schedules II, III, and IV controlled substances shall adopt standards regarding the frequency and circumstances under which their respective licensees shall query the VPMS. () Each professional licensing authority for dispensers shall adopt standards regarding the frequency and circumstances under which its licensees shall report to the VPMS, which shall be no less than once every seven days.
16 0 Page of 0 0 () Each professional licensing authority for health care providers and dispensers shall consider the standards adopted pursuant to this section in disciplinary proceedings when determining whether a licensee has complied with the applicable standard of care. () No later than January, 0, each professional licensing authority subject to this subsection shall submit its standards to the VPMS advisory committee. Sec.. V.S.A. 0 is added to read: 0. 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.
17 0 Page of 0 0 (d) When a dispenser fills a replacement prescription, the dispenser shall report the required information to the VPMS and shall indicate that the prescription is a replacement by completing the VPMS field provided for such purpose. In addition, the dispenser shall report to the VPMS the name of the person picking up the replacement prescription, if not the patient. (e) The VPMS shall create a mechanism by which individuals authorized to access the system pursuant to section of this title may search the database for information on all or a subset of all replacement prescriptions. Sec.. VPMS ADVISORY COMMITTEE (a)() The Commissioner shall maintain an advisory committee to assist in the implementation and periodic evaluation of the Vermont Prescription Monitoring System (VPMS). () The Department shall consult with the VPMS Advisory Committee concerning any potential operational or economic impacts on dispensers and health care providers related to transmission system equipment and software requirements. () The Committee shall develop guidelines for use of the VPMS by dispensers, health care providers, and delegates, and shall make recommendations concerning under what circumstances, if any, the Department shall or may give VPMS data, including data thresholds for such
18 0 Page of 0 0 disclosures, to law enforcement personnel. The Committee shall also review and approve advisory notices prior to publication. () The Committee shall make recommendations regarding ways to improve the utility of the VPMS and its data. () The Committee shall have access to aggregated, de-identified data from the VPMS. (b) The VPMS Advisory Committee shall be chaired by the Commissioner of Health or designee and shall include the following members: () the Deputy Commissioner of Health for Alcohol and Drug Abuse Programs; () a representative from the Vermont Medical Society; () a representative from the American College of Emergency Physicians - Vermont Chapter; () a representative from the Vermont State Nurses Association; () a representative from the Vermont Board of Medical Practice; () a representative from the Vermont Board of Pharmacy; () a representative from the Vermont Pharmacists Association; () a representative from the Vermont State Dental Society; () the Commissioner of Public Safety; (0) a representative of the Vermont Attorney General;
19 0 Page of 0 () a representative of the Vermont Substance Abuse Treatment Providers Association; () a mental health provider or a certified alcohol and drug abuse counselor; () a consumer in recovery from prescription drug abuse; () a consumer receiving medical treatment for chronic pain; and () any other member invited by the Commissioner. (c) The Committee shall meet at least once annually but may be convened at any time by the Commissioner or the Commissioner s designee. (d) No later than January, 0, the Committee shall provide recommendations to the House Committee on Human Services and the Senate Committee on Health and Welfare regarding ways to maximize the effectiveness and appropriate use of the VPMS database, including adding new reporting capabilities, in order to improve patient outcomes and avoid prescription drug diversion. (e) The Committee shall cease to exist on July, 0. Sec.. UNIFIED PAIN MANAGEMENT SYSTEM ADVISORY 0 COUNCIL (a) There is hereby created a Unified Pain Management System Advisory Council for the purpose of advising the Commissioner of Health on matters
20 0 Page 0 of 0 0 relating to the appropriate use of controlled substances in treating chronic pain and addiction and in preventing prescription drug abuse. (b) The Unified Pain Management System Advisory Council shall consist of the following members: () the Commissioner of Health or designee, who shall serve as chair; () the Deputy Commissioner of Health for Alcohol and Drug Abuse Programs or designee; () the Commissioner of Mental Health or designee; () the Director of the Blueprint for Health or designee; () the Chair of the Board of Medical Practice or designee, who shall be a clinician; () a representative of the Vermont State Dental Society, who shall be a dentist; () a representative of the Vermont Board of Pharmacy, who shall be a pharmacist; () a faculty member from the academic detailing program at the University of Vermont s College of Medicine; () a faculty member from the University of Vermont s College of Medicine with expertise in the treatment of addiction or chronic pain management;
21 0 Page of 0 0 (0) a representative of the Vermont Medical Society, who shall be a primary care clinician; () a representative of the American Academy of Family Physicians, Vermont chapter, who shall be a primary care clinician; () a representative of the Federally Qualified Health Centers, who shall be a primary care clinician selected by the Bi-State Primary Care Association; () a representative of the Vermont Ethics Network; () a representative of the Hospice and Palliative Care Council of Vermont; () a representative of the Office of the Health Care Ombudsman; () the Medical Director for the Department of Vermont Health Access; () a clinician who works in the emergency department of a hospital, to be selected by the Vermont Association of Hospitals and Health Systems in consultation with any nonmember hospitals; () a member of the Vermont Board of Nursing Subcommittee on APRN Practice, who shall be an advanced practice registered nurse; () a representative from the Vermont Assembly of Home Health and Hospice Agencies;
22 0 Page of 0 0 (0) a psychologist licensed pursuant to V.S.A. chapter who has experience in treating chronic pain, to be selected by the Board of Psychological Examiners; () a drug and alcohol abuse counselor licensed pursuant to V.S.A. chapter, to be selected by the Deputy Commissioner of Health for Alcohol and Drug Abuse Programs; and () a consumer representative who is either a consumer in recovery from prescription drug abuse or a consumer receiving medical treatment for chronic noncancer-related pain. (c) Advisory Council members who are not employed by the State or whose participation is not supported through their employment or association shall be entitled to per diem and expenses as provided by V.S.A. 00. (d) A majority of the members of the Advisory Council shall constitute a quorum. The Advisory Council shall act only by a majority vote of the members present and voting and only at meetings called by the Chair or by any three of the members. (e) To the extent funds are available, the Advisory Council shall have the following duties: () to develop and recommend principles and components of a unified pain management system, including the appropriate use of controlled
23 0 Page of 0 substances in treating noncancer-related chronic pain and addiction and in preventing prescription drug abuse; () to identify and recommend components of evidence-based training modules and minimum requirements for the continuing education of all licensed health care providers in the State who treat chronic pain or addiction or prescribe controlled substances in Schedule II, III, or IV consistent with a unified pain management system; () to identify and recommend evidence-based training modules for all employees of the Agency of Human Services who have direct contact with recipients of services provided by the Agency or any of its departments; and () to identify and recommend system goals and planned assessment tools to ensure that the initiative s progress can be monitored and adapted as needed. (f) The Commissioner of Health may designate subcommittees as appropriate to carry out the work of the Advisory Council. (g) On or before January, 0, the Advisory Council shall submit its recommendations to the Senate Committee on Health and Welfare, the House Committee on Human Services, and the House Committee on Health Care. Sec.. UNUSED DRUG DISPOSAL PROGRAM PROPOSAL 0 (a) On or before October, 0, the Commissioners of Health and of Public Safety shall provide recommendations to the House and Senate
24 0 Page of 0 0 Committees on Judiciary, the House Committee on Human Services, and the Senate Committee on Health and Welfare regarding the design and implementation of a statewide Unused Drug Disposal Program for unused over-the-counter and prescription drugs at no charge to the consumer. In preparing their recommendations, the Commissioners shall consider successful unused drug disposal programs in Vermont, including the Bennington County Sheriff s Department s program, and in other states. (b) On or before January, 0, the Commissioners of Health and of Public Safety shall implement the Unused Drug Disposal Program developed pursuant to subsection (a) of this section and shall take steps to publicize the Program and to make all Vermont residents aware of opportunities to avail themselves of it. Sec.. TRACK AND TRACE PILOT PROJECT (a) The Departments of Health and of Vermont Health Access shall establish a track and trace pilot project with one or more manufacturers of buprenorphine to create a high-integrity monitoring tool capable of use across disciplines. The tool shall be designed to identify irregularities related to dosing and quality in a manner that disrupts practice operations to the least extent possible. The Departments shall work with all willing Medicaid-enrolled prescribing practices and pharmacies to use the tool.
25 0 Page of 0 0 (b) On or before January, 0, the Commissioners of Health and of Vermont Health Access shall provide testimony on the status of the pilot project established pursuant to this section to the House Committees on Human Services and on Judiciary and the Senate Committees on Health and Welfare and on Judiciary. Sec.. ADVISORY COMMITTEE REPORT On or before January, 0, the VPMS Advisory Committee shall provide recommendations to the House Committee on Human Services and the Senate Committee on Health and Welfare regarding ways to maximize the effectiveness and appropriate use of the VPMS database, including adding new reporting capabilities, in order to improve patient outcomes and avoid prescription drug diversion. Sec.. SPENDING AUTHORITY Providing financial support for the Unified Pain Management System Advisory Council established in Sec. of this act, upgrading the VPMS software, and implementing enhancements to the VPMS shall all be acceptable uses of the monies in the Evidence-Based Education and Advertising Fund established in V.S.A. 00a. The Commissioner of Health shall seek excess receipts authority to make expenditures as needed from the Evidence-Based Education and Advertising Fund for these purposes.
26 0 Page of 0 Sec. 0. INTEGRATION; LEGISLATIVE INTENT It is the intent of the General Assembly that the initiatives described in this act should be integrated to the extent possible with the Blueprint for Health and the mental health system of care. Sec.. EFFECTIVE DATES (a) This section and Sec. of this act (VPMS Advisory Committee) shall take effect on passage. (b) Secs. ( V.S.A. ; reciprocal agreements), ( V.S.A. ; standards and guidelines), and ( V.S.A. 0; replacement prescriptions) and Sec. (b)()(g) ( V.S.A. (b)()(g); interstate data sharing) of this act shall take effect on October, 0. (c) The remaining sections of this act shall take effect on July, 0.
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