Bill Text: IA SSB3071 | 2017-2018 | 87th General Assembly | Introduced


Bill Title: A bill for an act relating to the Iowa prescription monitoring program, including by establishing an advisory committee, authorizing a registration surcharge, expanding information collection and reporting requirements, and making penalties applicable.

Spectrum: Committee Bill

Status: (N/A - Dead) 2018-01-30 - Subcommittee recommends passage. [SSB3071 Detail]

Download: Iowa-2017-SSB3071-Introduced.html
Senate Study Bill 3071 - Introduced SENATE/HOUSE FILE _____ BY (PROPOSED BOARD OF PHARMACY BILL) A BILL FOR An Act relating to the Iowa prescription monitoring program, 1 including by establishing an advisory committee, authorizing 2 a registration surcharge, expanding information collection 3 and reporting requirements, and making penalties applicable. 4 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 5 TLSB 5275DP (8) 87 ss/rh
S.F. _____ H.F. _____ Section 1. Section 124.550, Code 2018, is amended by adding 1 the following new subsection: 2 NEW SUBSECTION . 3. “Proactive notification” means 3 a notification by the board, generated based on factors 4 determined by the board and issued to a specific prescribing 5 practitioner or pharmacist, indicating that a patient may 6 be practitioner shopping or pharmacy shopping or at risk of 7 abusing or misusing a controlled substance. 8 Sec. 2. Section 124.551, subsection 1, Code 2018, is amended 9 to read as follows: 10 1. Contingent upon the receipt of funds pursuant to 11 section 124.557 sufficient to carry out the purposes of 12 this subchapter , the board, in conjunction with the advisory 13 council committee created in section 124.555 , shall establish 14 and maintain an information program for drug prescribing and 15 dispensing. 16 Sec. 3. Section 124.552, Code 2018, is amended to read as 17 follows: 18 124.552 Information reporting. 19 1. Each Unless otherwise prohibited by federal or state law, 20 each licensed pharmacy that dispenses controlled substances 21 identified pursuant to section 124.554, subsection 1 , paragraph 22 “g” , to patients in the state, and each licensed pharmacy 23 located in the state that dispenses such controlled substances 24 identified pursuant to section 124.554, subsection 1 , 25 paragraph “g” , to patients inside or outside the state, unless 26 specifically excepted in this section or by rule, and each 27 prescribing practitioner furnishing, dispensing, or supplying 28 controlled substances to the prescribing practitioner’s 29 patient, shall submit the following prescription information 30 to the program: 31 a. Pharmacy identification. 32 b. Patient identification. 33 c. Prescribing practitioner identification. 34 d. The date the prescription was issued by the prescribing 35 -1- LSB 5275DP (8) 87 ss/rh 1/ 10
S.F. _____ H.F. _____ practitioner. 1 e. The date the prescription was dispensed. 2 f. An indication of whether the prescription dispensed is 3 new or a refill. 4 g. Identification of the drug dispensed. 5 h. Quantity of the drug dispensed. 6 i. The number of days’ supply of the drug dispensed. 7 j. Serial or prescription number assigned by the pharmacy. 8 k. Type of payment for the prescription. 9 l. Other information identified by the board and advisory 10 council by rule. 11 2. Information shall be submitted electronically in a 12 secure format specified by the board unless the board has 13 granted a waiver and approved an alternate secure format. 14 3. Information shall be timely transmitted as designated by 15 the board and advisory council by rule, unless the board grants 16 an extension. The board may grant an extension if either of 17 the following occurs: 18 a. The pharmacy or prescribing practitioner suffers 19 a mechanical or electronic failure, or cannot meet the 20 deadline established by the board for other reasons beyond the 21 pharmacy’s or practitioner’s control. 22 b. The board is unable to receive electronic submissions. 23 4. This section shall not apply to a prescribing 24 practitioner furnishing, dispensing, supplying, or 25 administering drugs to the prescribing practitioner’s patient, 26 or to dispensing by a licensed pharmacy for the purposes of 27 inpatient hospital care, inpatient hospice care, or long-term 28 residential facility patient care. 29 Sec. 4. Section 124.553, subsection 1, paragraph b, Code 30 2018, is amended to read as follows: 31 b. An individual who requests the individual’s own program 32 information in accordance with the procedure established in 33 rules of the board and advisory council adopted under section 34 124.554. 35 -2- LSB 5275DP (8) 87 ss/rh 2/ 10
S.F. _____ H.F. _____ Sec. 5. Section 124.553, subsection 1, Code 2018, is amended 1 by adding the following new paragraph: 2 NEW PARAGRAPH . g. A prescribing practitioner or pharmacist 3 through the use of a targeted distribution of proactive 4 notifications. 5 Sec. 6. Section 124.553, subsections 2, 3, and 7, Code 2018, 6 are amended to read as follows: 7 2. The board shall maintain a record of each person that 8 requests information from the program and of all proactive 9 notifications distributed to prescribing practitioners and 10 dispensing pharmacists as provided in subsection 1, paragraph 11 “g” . Pursuant to rules adopted by the board and advisory 12 council under section 124.554 , the board may use the records 13 to document and report statistical information, and may 14 provide program information for statistical, public research, 15 public policy, or educational purposes, after removing 16 personal identifying information of a patient, prescribing 17 practitioner, dispenser, or other person who is identified in 18 the information. 19 3. Information contained in the program and any information 20 obtained from it, and information contained in the records 21 of requests for information from the program and information 22 distributed to prescribing practitioners and dispensing 23 pharmacists as provided in subsection 1, paragraph “g” , 24 is privileged and strictly confidential information. Such 25 information is a confidential public record pursuant to section 26 22.7 , and is not subject to discovery, subpoena, or other 27 means of legal compulsion for release except as provided in 28 this subchapter . Information from the program shall not be 29 released, shared with an agency or institution, or made public 30 except as provided in this subchapter . 31 7. The Except as allowed in section 124.557, the 32 board shall not charge a fee to a pharmacy, pharmacist, or 33 prescribing practitioner for the establishment, maintenance, 34 or administration of the program, including costs for forms 35 -3- LSB 5275DP (8) 87 ss/rh 3/ 10
S.F. _____ H.F. _____ required to submit information to or access information from 1 the program , except that the . The board may charge a fee 2 to an individual who requests the individual’s own program 3 information. A fee charged to an individual pursuant to this 4 subsection shall not exceed the actual cost of providing the 5 requested information and shall be considered a repayment 6 receipt as defined in section 8.2 . 7 Sec. 7. Section 124.554, Code 2018, is amended to read as 8 follows: 9 124.554 Rules and reporting. 10 1. The board and advisory council , in consultation with the 11 advisory committee, shall jointly adopt rules in accordance 12 with chapter 17A to carry out the purposes of, and to enforce 13 the provisions of, this subchapter . The rules shall include 14 but not be limited to the development of procedures relating 15 to: 16 a. Identifying each patient about whom information is 17 entered into the program. 18 b. An electronic format for the submission of information 19 from pharmacies and prescribing practitioners . 20 c. A waiver to submit information in another format for 21 a pharmacy or prescribing practitioner unable to submit 22 information electronically. 23 d. An application by a pharmacy or prescribing practitioner 24 for an extension of time for transmitting information to the 25 program. 26 e. The submission by an authorized requestor of a request 27 for information and a procedure for the verification of the 28 identity of the requestor. 29 f. Use by the board or advisory council committee of the 30 program request records required by section 124.553, subsection 31 2 , to document and report statistical information. 32 g. Including all schedule II , schedule III, schedule IV, 33 controlled substances and those substances in schedules III 34 and IV that the advisory council and board determine can be 35 -4- LSB 5275DP (8) 87 ss/rh 4/ 10
S.F. _____ H.F. _____ addictive or fatal if not taken under the proper care and 1 direction of a prescribing practitioner schedule V controlled 2 substances except when dispensed by a pharmacist without a 3 prescription . 4 h. Access by a pharmacist or prescribing practitioner to 5 information in the program pursuant to a written agreement with 6 the board and advisory council . 7 i. The correction or deletion of erroneous information in 8 the program. 9 j. The establishment of thresholds or other criteria or 10 measures to be used in identifying an at-risk patient as 11 provided in section 124.553, subsection 1, paragraph “g” , and 12 the targeted distribution of proactive notifications suggesting 13 review of the patient’s prescription history. 14 k. User registration processes and requirements. 15 2. Beginning January 1, 2007 15, 2019 , and annually by 16 January 1 15 thereafter, the board and advisory council 17 committee shall present to the general assembly and the 18 governor a report prepared consistent with section 124.555, 19 subsection 3 , paragraph “d” , which shall include but not be 20 limited to the following: 21 a. The cost to the state of implementing and maintaining the 22 program. 23 b. Information from pharmacies, prescribing practitioners, 24 the board, the advisory council committee , and others regarding 25 the benefits or detriments of the program. 26 c. Information from pharmacies, prescribing practitioners, 27 the board, the advisory council committee , and others regarding 28 the board’s effectiveness in providing information from the 29 program. 30 Sec. 8. Section 124.555, Code 2018, is amended to read as 31 follows: 32 124.555 Advisory council committee established. 33 An advisory council committee shall be established to 34 provide oversight to the board and the program and to comanage 35 -5- LSB 5275DP (8) 87 ss/rh 5/ 10
S.F. _____ H.F. _____ program activities. The board and , in consultation with 1 the advisory council committee, shall jointly adopt rules 2 specifying the duties and activities of the advisory council 3 committee and related matters. 4 1. The council committee shall consist of eight a minimum 5 of four members appointed by the governor board . The members 6 shall include but not be limited to at least one member from 7 each of the following categories: three licensed pharmacists, 8 four physicians licensed under chapter 148 , and one licensed 9 prescribing practitioner practitioners who is are not a 10 physician physicians, and public members who are not health 11 care professionals . The governor shall board may solicit 12 recommendations for council committee members from Iowa health 13 professional licensing boards, associations, and societies , 14 and other interested groups . The license of each health care 15 professional member appointed to and serving on the advisory 16 council committee shall be current and in good standing with 17 the professional’s licensing board. 18 2. The council committee shall advance the goals of the 19 program, which include identification of misuse and diversion 20 of controlled substances identified pursuant to section 21 124.554, subsection 1 , paragraph “g” , reduction of overdoses 22 and deaths as a result of prescription controlled substance 23 use and abuse, and enhancement of the quality of health care 24 delivery in this state. 25 3. Duties of the council committee shall include but not be 26 limited to the following: 27 a. Ensuring the confidentiality of the patient, prescribing 28 practitioner, and dispensing pharmacist and pharmacy. 29 b. Respecting and preserving the integrity of the patient’s 30 treatment relationship with the patient’s health care 31 providers. 32 c. Encouraging and facilitating cooperative efforts 33 among health care practitioners and other interested and 34 knowledgeable persons in developing best practices for 35 -6- LSB 5275DP (8) 87 ss/rh 6/ 10
S.F. _____ H.F. _____ prescribing and dispensing controlled substances and in 1 educating health care practitioners and patients regarding 2 controlled substance use and abuse. 3 d. Making recommendations regarding the continued benefits 4 of maintaining the program in relationship to cost and other 5 burdens to the patient, prescribing practitioner, pharmacist, 6 and the board. The council’s committee’s recommendations shall 7 be included in reports required by section 124.554, subsection 8 2 . 9 e. One physician and one pharmacist member of the council 10 shall include in their duties the responsibility for monitoring 11 and ensuring that patient confidentiality, best interests, and 12 civil liberties are at all times protected and preserved during 13 the existence of the program. 14 4. Members of the advisory council committee shall 15 be eligible to request and receive actual expenses for 16 their duties as members of the advisory council committee , 17 subject to reimbursement limits imposed by the department of 18 administrative services, and shall also be eligible to receive 19 a per diem compensation as provided in section 7E.6, subsection 20 1 . 21 Sec. 9. Section 124.556, Code 2018, is amended to read as 22 follows: 23 124.556 Education and treatment. 24 The program for drug prescribing and dispensing shall 25 include education initiatives and outreach to consumers, 26 prescribing practitioners, and pharmacists, and shall also 27 include assistance for identifying substance abuse treatment 28 programs and providers. The board and advisory council 29 committee shall adopt rules, as provided under section 124.554 , 30 to implement this section . 31 Sec. 10. Section 124.557, Code 2018, is amended to read as 32 follows: 33 124.557 Drug information program fund. 34 The drug information program fund is established to be used 35 -7- LSB 5275DP (8) 87 ss/rh 7/ 10
S.F. _____ H.F. _____ by the board to fund or assist in funding the program. The 1 board may make deposits into the fund from any source, public 2 or private, including grants or contributions of money or other 3 items of value, which it determines necessary to carry out the 4 purposes of this subchapter . The board may add a surcharge 5 of not more than twenty-five percent to the applicable fee 6 for a registration issued pursuant to section 124.302 and the 7 surcharge shall be deposited into the fund. Moneys received 8 by the board to establish and maintain the program must 9 be used for the expenses of administering this subchapter . 10 Notwithstanding section 8.33 , amounts contained in the fund 11 that remain unencumbered or unobligated at the close of the 12 fiscal year shall not revert but shall remain available for 13 expenditure for the purposes designated in future years. 14 Sec. 11. Section 124.558, subsection 1, Code 2018, is 15 amended to read as follows: 16 1. Failure to comply with requirements. A pharmacist, 17 pharmacy, prescribing practitioner, or agent of a pharmacist 18 or prescribing practitioner who knowingly fails to comply 19 with the confidentiality requirements of this subchapter 20 or who delegates program information access to another 21 individual except as provided in section 124.553 , is subject to 22 disciplinary action by the appropriate professional licensing 23 board. A pharmacist , or pharmacy , or prescribing practitioner 24 that knowingly fails to comply with other requirements of this 25 subchapter is subject to disciplinary action by the board. 26 Each licensing board may adopt rules in accordance with chapter 27 17A to implement the provisions of this section . 28 Sec. 12. TRANSITION —— APPOINTMENT AND TERMS OF ADVISORY 29 COMMITTEE MEMBERS. This Act’s amendments changing the name of 30 the “advisory council” to the “advisory committee” shall not 31 affect the appointment of a member who served on the advisory 32 council immediately prior to the effective date of this Act. 33 That member shall continue to serve on the advisory committee 34 at the pleasure of the governor. 35 -8- LSB 5275DP (8) 87 ss/rh 8/ 10
S.F. _____ H.F. _____ Sec. 13. TRANSITION —— ADMINISTRATIVE RULES AND OTHER 1 ACTIONS AND DOCUMENTS. Any rule, form, order, or directive 2 promulgated by the advisory council created in section 124.550, 3 in force and effect immediately prior to the effective date of 4 this Act, shall continue in full force and effect until the 5 earlier of the following: 6 1. It is amended, rescinded, or supplemented by the 7 affirmative actions of the board of pharmacy. 8 2. It expires by its own terms. 9 EXPLANATION 10 The inclusion of this explanation does not constitute agreement with 11 the explanation’s substance by the members of the general assembly. 12 This bill alters the Iowa prescription monitoring program 13 (PMP) by establishing an advisory committee, authorizing a 14 registration surcharge, expanding information collection and 15 reporting requirements, and making penalties applicable to 16 dispensing practitioners. 17 The bill adds dispensing prescribers to the list of persons 18 required to report to the PMP the dispensation of reportable 19 controlled substances to patients in Iowa, subject to the 20 same exceptions provided to pharmacies, unless otherwise 21 prohibited by state or federal law. The bill also eliminates 22 the PMP advisory council and creates an advisory committee to 23 assume the duties of the advisory council, with members to be 24 appointed from among health care professionals and the general 25 public by the board in numbers to be determined by the board, 26 provided the committee consists of at least four members. 27 The bill provides that members of the advisory council shall 28 continue to serve on the advisory committee and that any 29 rule, form, order, or directive promulgated by the advisory 30 council shall continue to be in force and effect until they are 31 amended, rescinded, or supplemented by the board of pharmacy 32 or expire by their own terms. 33 The bill also allows the board, in consultation with 34 the PMP advisory committee, to establish criteria for the 35 -9- LSB 5275DP (8) 87 ss/rh 9/ 10
S.F. _____ H.F. _____ identification of patients who are potentially misusing or 1 abusing prescription controlled substances and authorizes the 2 board to proactively notify the pharmacists and prescribing 3 practitioner involved in the patient’s care of its concerns. 4 The bill authorizes the collection of dispensing records for 5 all schedule II, III, IV, and V controlled substances except 6 when the schedule V controlled substance is dispensed by a 7 pharmacist without a prescription. The bill also authorizes, 8 but does not require, the board to impose a surcharge to 9 be deposited into the drug information program fund on 10 controlled substances Act registrations, which any person who 11 manufactures, distributes, or dispenses a controlled substance 12 must obtain and maintain, to be used for the expenses of 13 administering the PMP. 14 The bill adds to the goals of the program the reduction of 15 overdoses and deaths as a result of prescription controlled 16 substance use and abuse. The bill also changes the due 17 date for annual reports to the governor and the legislature 18 regarding the program from January 1 to January 15. 19 The bill makes prescribing practitioners subject to 20 disciplinary action by the board under Code section 124.558 for 21 failure to comply with the reporting requirement. 22 -10- LSB 5275DP (8) 87 ss/rh 10/ 10
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