For rules 64K-1.001, .002, .003, .004 and .007, F.A.C., to provide for revising the requirements for reporting dispensing of controlled substances, to allow employees of the U.S. Department of Veterans Affairs, U. S. Department of Defense, and ...

 

DEPARTMENT OF HEALTH

Prescription Drug Monitoring Program

RULE NO.:RULE TITLE:

64K-1.001Patient Advisory Alerts and Reports

64K-1.002American Society of Automation in Pharmacy Standards and Formats

64K-1.003Accessing Database

64K-1.004Management and Operation of Database

64K-1.007Indicators of Controlled Substance Abuse

64K-1.008Electronic Health Recordkeeping System Integration

PURPOSE AND EFFECT: For rules 64K-1.001, .002, .003, .004 and .007, F.A.C., to provide for revising the requirements for reporting dispensing of controlled substances, to allow employees of the U.S. Department of Veterans Affairs, U. S. Department of Defense, and Indian Health Services to access certain information pursuant to recently enacted legislation. For rules 64K-1.007 and .008, F.A.C, to provide the process for approved entities to connect electronic health recordkeeping systems to the Prescription Drug Monitoring Program system as required by recently enacted legislation.

SUMMARY: For rules 64K-1.001, .002, .003, .004 and .007, F.A.C., reporting and query requirements for dispensers and prescribers of controlled substances and access to certain nformation by employees of the U.S. Department of Veterans Affairs, U.S. Department of Defense, and Indian Health Services pursuant to recently enacted legislation. For rule 64K-1.007 and .008, F.A.C., electronic health recordkeeping system connections with the Prescription Drug Monitoring Program system as required by recently enacted legislation.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Based on the SERC checklist, this rulemaking will not have an adverse impact on regulatory costs in excess of $1 million within five years as established in s.120.541(2)(a), F.S.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 893.055, FS.

LAW IMPLEMENTED: 893.055, 893.0551, FS.

A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: Thursday, August 23, 2018, 1:00 p.m. to 5:00 p.m.

PLACE: Florida Department of Health, 4042 Bald Cypress Way, Room 301, Tallahassee, FL 32311

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca Poston, Program Manager, Prescription Drug Monitoring program, 4052 Bald Cypress Way, Bin #C-16, Tallahassee, Florida 32399 or [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

64K-1.001 Patient Advisory Alerts and Reports.

Rulemaking Authority 893.055 FS. Law Implemented 893.055 FS. History–New 11-24-11, Repealed                 .         

 

64K-1.002 American Society for Automation in Pharmacy Standards and Formats.

The format for submission to the E‑FORCSE® database shall be in accordance with the electronic reporting standards of the American Society for Automation in Pharmacy (ASAP) contained in the  “Implementation Guide ASAP Standard for Prescription Monitoring Programs Version 4, Release 2A 2,” (10/2016) (9/2011), incorporated by reference. E‑FORCSE® The PDMP will continue to accept reports in the ASAP 2011 2009 version 4.2 4.1 standard for one year from the effective date of this rule (to be determined October 21, 2015), after which all reports must be made using the ASAP 2016 version 4.2A 2011 version 4.2 standard. The format for submission to the E‑FORCSE® database if no controlled substances are dispensed shall be in accordance with the incorporated by reference ASAP Error and Zero Report Standard (10/2016 9/2011). The agency has determined that posting the incorporated materials would be a violation of federal copyright law. The materials are available for public inspection at the Department of Health, 4052 Bald Cypress Way, Tallahassee, FL 32399, and the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, FL 32399. A copy of the eElectronic rReporting Standard for Prescription Drug Monitoring Programs may be obtained from the American Society for Automation in Pharmacy, 492 Norristown Road, Suite 160, Blue Bell, Pennsylvania 19422, Telephone: [phone], Website: www.asapnet.org.

Rulemaking Authority 893.055 FS. Law Implemented 893.055 FS. History–New 2-20-12, Amended 10-21-15,              .

 

64K-1.003 Accessing Database.

(1) Definitions:

(a) “Designee” means a person, preferably a licensed or certified health care professional, appointed to act as an agent of a prescriber or dispenser for the purposes of requesting or receiving information from the Prescription Drug Monitoring Program database, E‑FORCSE®.

(b) “E‑FORCSE®” is the comprehensive electronic database system established by the Department of Health that has controlled substance prescribing and dispensing information reported to it and that provides the information to persons and entities allowed by law to access, request and receive this information. 

(c) “Electronic health record” is an electronic or digital version of a patient’s medical history, maintained over time and may include all of the key administrative clinical data relevant to that person’s medical care under a particular provider, including demographics, progress notes, problems, medications, vital signs, past medical history, immunizations, laboratory data and radiology reports. The electronic health record uses computer hardware and software for the storage, retrieval, sharing and use of health care information and data.

(d)(b) “Impaired practitioner consultant” means an approved impaired practitioner program designated by the department through contract with a consultant to evaluate, refer and monitor impaired practitioners. The department has designated the Intervention Project for Nurses (IPN) and Professionals Resource Network (PRN) as the Approved Impaired Practitioner Programs.

(e) “Order” means a written, transmitted or oral direction from a prescriber for a controlled substance to be administered to a patient in an inpatient setting.

(f) “Prescribe” means the act of a prescriber issuing, writing or transmitting a direction to a pharmacist to dispense a specified controlled substance to a specified patient.

(2) Pharmacists, prescribers and dispensers, or their designees, are required to access and consult E‑FORCSE® to review a patient’s controlled substance dispensing history each time a controlled substance, other than a nonopioid drug listed on Schedule V, is prescribed or dispensed, but not ordered, for a patient age 16 or older unless a statutory exception applies.

(3)(2)(a) Pharmacists, prescribers and dispensers licensed in Florida may directly access the information in E‑FORCSE® the program database by registering on the E‑FORCSE® secure web portal at https://florida.pmpaware.net/login https://flpdmp-phreg.hidinc.com using the temporary user name “newacct” and temporary password “welcome.” A written request may be submitted to the program manager if information must be received by alternate means. A pharmacist, prescriber or dispenser must review the “PMP AWARxE User Support Manual Training Guide for Florida Practitioners and Pharmacists,” DH8009-PDMP, effective 7/2018 7/2016, which is incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-          07628, prior to registering. Certification of this review is required before registration can be completed. A permanent user name and password will be emailed to the successful registrant. Registration denials, stating the reason for denial, will be emailed to the unsuccessful registrant.

(b) A prescriber or dispenser may request and receive information from E‑FORCSE® the database using a secure recordkeeping system integration web service associated with his or her electronic health record The web service shall transmit the authorized user’s login credentials and query parameters to E‑FORCSE® for authentication. If the user is authenticated, E‑FORCSE® will return query results to the authorized user through the web service for display only viewing within the authorized user’s electronic health record.

(4)(3)(a) A designee of a prescriber or dispenser may directly access the information in E‑FORCSE® the program database by registering on the E‑FORCSE® secure web portal at https://florida.pmpaware.net/login https://flpdmp-phreg.hidinc.com using the temporary user name “newacct” and temporary password “welcome.” A written request may be submitted to the program manager if information must be received by alternate means. A designee must review the “PMP AWARxE User Support Manual Training Guide for Florida Practitioners and Pharmacists” and the “Information Security and Privacy Training Course for Designees,” DH8019-PDMP, effective 7/2016, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-07629, prior to registering. A permanent user name and password will be emailed to the successful registrant. Registration denials, stating the reason for the denial, will be emailed to the unsuccessful registrant.

(b) A registered designee will not have access to E‑FORCSE® the database until the designating prescriber or dispenser affirmatively accepts responsibility for the designee and links the designee to a pharmacy, prescriber or dispenser E‑FORCSE® account as described in the “PMP AWARxE User Support Manual Training Guide for Florida Practitioners and Pharmacists.” The linking process will require the prescriber or dispenser to certify that the designee has reviewed the “PMP AWARxE User Support Manual Training Guide for Florida Practitioners and Pharmacists” and the “Information Security and Privacy Training Course for Designees.” The designating prescriber or dispenser shall maintain printed copies of the certification of these reviews and make them available to the program manager upon request.

(c) Registered designees who do not access the E‑FORCSE® database for a period in excess of six months will be deactivated. Deactivated designees may reapply for access.

(5)(4) Prescribers and dispensers and their designees employed by the United States Department of Veterans Affairs (DVA), United States Department of Defense (DOD), and the Indian Health Service (IHS) who are authorized to prescribe or dispense controlled substance and are not licensed in Florida but provide health care services to patients in this state pursuant to such employment, may directly access E‑FORCSE® by registering at https://florida.pmpaware.net/login.  An employee of the DVA, DOD and IHS must review the “PMP AWARxE User Support Manual” prior to registering.  A permanent user name will be emailed to the successful registrant.  Registration denials, stating the reason for the denial, will be emailed to the unsuccessful registrant.

(a) A registered employee of the DVA, DOD, and IHS will not have access to E‑FORCSE® until his or her employment is verified.

(b) Direct access to the information in E‑FORCSE® is limited to the information that relates to a patient of such employee and may be accessed only for the purpose of reviewing that patient’s controlled substance prescription history.

(c) A prescriber or dispenser or designee employed by the DVA, DOD or IHS that is an authorized E‑FORCSE user must notify E-FORSCE within 30 days of termination of employment.

(6)(a) Entities that do not have direct access to E‑FORCSE® the database may request information from the program manager by having the agency head or a person appointed by the agency head for this purpose execute an “Agency User Agreement,” DH8017-PDMP, effective 7/2015, incorporated herein by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-06462. If approved, the program manager will execute and return the agreement to the agency.

(b) After approval of the Agency User Agreement, each agency head or person appointed by the agency head for this purpose shall appoint an agency administrator with an “Agency Administrator Appointment Form,” DH 8010-PDMP, effective 1/2015, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-06457. Approved administrators will be notified and provided instructions for appointing authorized users.

(c) Each agency head or person appointed by the agency head for this purpose shall immediately notify the program manager or support staff of a change in the agency administrator. Authority to request and receive information from the E‑FORCSE® database shall be suspended during an agency administrator vacancy.

(d) Each agency administrator may appoint authorized users to request and receive information on behalf of the agency using an “Agency Authorized User Appointment Form,” DH-8015-PDMP, effective 1/2015, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-06460. Prior to appointment each authorized user must review the “Training Guide for Enforcement and Investigative Agencies,” DH-8012-PDMP, effective 7/2018 6/2016, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-          07630, and the “E‑FORCSE® Information Security and Privacy Training Course,” effective 7/2016, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-07631. Certification of these reviews is required before registration can be completed. The authorized user must provide printed copies of the certifications from both courses to the agency administrator who shall maintain them for the duration of the appointment and make them available for examination upon request of the program manager. Approved authorized users will be notified by email and provided with instructions for requesting and receiving information from through the secure E‑FORCSE® web portal.

(e) An authorized user must have actual knowledge of an active investigation as defined by section 893.055(1)(a h), F.S., prior to submitting a request and is prohibited from requesting information on behalf of another law enforcement agency or entity.

(f) Each agency administrator shall immediately notify the program manager or support staff by email of authorized user changes and verify the list of authorized users on or immediately prior to June 30 of each year.

(7)(5)(a) Impaired practitioner consultants do not have direct access to E‑FORCSE® the information in the database but may request and review information relating to persons referred to or participating in the approved impaired practitioner programs from the program manager by having the Medical Director or Executive Director of the approved impaired practitioner program execute an “Impaired Practitioner Consultant User Agreement,” DH8020-PDMP, effective 7/2016, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-07632. If approved, the program manager will execute and return the agreement to the Medical Director or Executive Director of the approved impaired practitioner program.

(b) The impaired practitioner consultant shall immediately notify the program manager or support staff of a change of Medical Director or Executive Director. Authority to request and receive information from the E‑FORCSE® database shall be suspended while the position of Medical Director or Executive Director is vacant.

(c) Upon approval of the impaired practitioner consultant user agreement, the Medical Director or Executive Director of the approved practitioner program may appoint up to three (3) authorized users who are employees of the approved impaired practitioner consultant to request and receive information on behalf of the approved impaired practitioner program using an “Impaired Practitioner Program Authorized User Appointment Form,” DH8022-PDMP, effective 7/2016, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-07633. Prior to appointment, each authorized user must review the “Training Guide for Impaired Practitioner Consultants,” DH8021-PDMP, effective 7/2018 7/2016, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-          07634. Certification of this review is required before registration can be completed. The authorized user must provide a printed copy of this certification to the Medical Director or Executive Director of the approved impaired practitioner program who shall maintain them for the duration of the appointment and make them available for examination upon request of the program manager. Approved authorized users will be notified by email and provided with instructions for requesting and receiving information from through the secure E‑FORCSE® web portal. Registration denials, stating the reason for the denial, will be emailed to the Medical Director or Executive Director.

(d) The Medical Director or Executive Director of the approved impaired practitioner consultant shall immediately notify the program manager or support staff by email of authorized user changes and verify the list of authorized users on or immediately prior to June 30 of each year.

(e) The person referred to or participating in the approved impaired practitioner program must provide written authorization for the approved impaired practitioner consultant to request and review any information from E‑FORCSE® relating to that person. The referred or participating person shall use the “Authorization for Impaired Practitioner Consultant Access,” Form DH8023-PDMP, effective 7/2016, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-07635, to provide this authorization. The impaired practitioner consultant or authorized user must upload the executed authorization form with the request for information from the E‑FORCSE® database relating to the referred or participating person. Each access for a referred person requires a new authorization form. Authorizations for impaired practitioner program participants can be in effect no longer than the duration of the monitoring contract with the impaired practitioner program. If approved, the program manager will return the information on the referred or participating person from E‑FORCSE® to the impaired practitioner consultant or authorized user through the secure E‑FORCSE® web portal. If denied, the program manager will notify the impaired practitioner consultant or authorized user with the reason for the denial.

(f) Impaired practitioner program consultants and authorized users may only query information relating to the referred or participating person who has given authorization to access the information, and not any prescriber or dispenser. An impaired practitioner program consultant may make a notation of the query in the impaired practitioner program file.

(g) Information in the E‑FORCSE® database relating to referred and participating persons accessed by impaired practitioner consultants and authorized users is confidential and exempt and shall not be disclosed or transmitted to any other person, program or entity, including the Department. To prevent inadvertent disclosure, the information should not be included in the referred or participating person’s impaired practitioner program file, downloaded or printed.

(8)(6) A patient or the legal guardian or designated health care surrogate of an incapacitated patient may request information from E‑FORCSE® the program database to verify the accuracy of the database information by contacting the Prescription Drug Monitoring Program by mail at 4052 Bald Cypress Way, Bin #C-16, Tallahassee, FL 32399-3254, or by telephone at [phone] and submitting. Requesters must complete form DH 2143, “Patient Information Request,” effective 7/2018 6/2016, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-          07636. The patient or other authorized person must make an appointment, appear in person at the program or department field office, and produce a valid government-issued identification, which includes a photograph, to review the requested information.

Rulemaking Authority, 893.055 FS. Law Implemented 893.055, 893.0551 FS. History–New 11-24-11, Amended 2-17-16, 2-14-17,              .

 

64K-1.004 Management and Operation of Database.

(1) All non-exempt entities that dispense controlled substances as defined in section 893.055(1)(c), F.S., Schedules II ‒ IV, are required to register and report to the program database. Orders for administration are exempt from reporting.

(2) Dispensers must register electronically at https://pmpclearinghouse.net/registrations/new.  https://flpdmp-reporting.hidinc/ using the temporary user name “newacct” and temporary password “welcome.” A permanent user name and password will be provided electronically to successful registrants. Prior to registration, a dispenser must review the “Data Submission Dispenser Guide Certification that the dispenser has reviewed the “Dispenser’s Implementation Guide,” DH8013-PDMP, effective 7/2018 7/2015, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-          06459, is required before registration can be completed.

(3) All dispensers shall electronically report dispensing information to E‑FORCSE® the program’s database as soon as possible, but no later than the close of the next business day after the day the controlled substance not more than 7 days after the controlled substance is dispensed. Extensions of time to report the dispensing of a controlled substance may be granted for no more than 30 days upon request to the program by any dispenser unable to submit data by electronic means if the dispenser provides evidence of having suffered a mechanical or electronic failure or cannot report for reasons beyond the control of the dispenser or if E‑FORCSE® the database is unable to receive submissions. A dispenser that has no dispensing transactions to report for the preceding business day seven-day period must submit a zero activity report as described in the “Data Submission Dispenser Guide “Dispenser’s Implementation Guide.”

(4) Dispensing information with errors or omissions shall be corrected and resubmitted to E‑FORCSE® the database by the reporting dispenser within one seven business day days of receiving electronic or written notice from the program manager or support staff of the error or omission.

(5) The program will file a complaint with the Department and refer to law enforcement any failure to report the dispensing of Schedules II – IV controlled substances as defined in section 893.055(1)(c), F.S.

(6) Pharmacies and registered dispensing practitioners that do not dispense controlled substances in or into this state must submit a “Notification of Exemption From Reporting,” DH8016-PDMP (effective 7/2018 7/2015), incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-          06461. Exemptions must be renewed on or before February 28 in odd years by making the appropriate election on the biennial pharmacy permit renewal form or on “Renewal of Notification of Exemption from Reporting Form,” DH8018-PDMP (effective 7/2018 7/2015), incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-          06463. Pharmacies and registered dispensing practitioners seeking to begin dispensing controlled substances must notify the program electronically and be removed from the exempt list prior to registering to report to the program database.

(7)(a) A patient, health care provider, prescriber, or dispenser may submit an electronic request to the program manager for the correction of erroneous information in E‑FORCSE® the database. The request shall include:

1. A statement explaining in detail the error and the basis for the requested correction.

2. The precise change requested.

3. Documentation establishing the correct information.

4. The requester’s name, address, telephone number, and license number if licensed as a health care provider in Florida.

(b) The program manager or support staff will review all requests to correct information and will request the reporting dispenser reporting the incorrect information to correct identified errors. No correction will be made if no error is found. The program will notify the entity or person requesting the correction of the results of the review.

(8) Information reported to E‑FORCSE® will be maintained in the database available for access for a period of 2 years from the date the prescription was dispensed.

(9) Information submitted to the database by dispensers directly dispensing a controlled substance shall include the telephone number of the person for whom the prescription was written.

Rulemaking Authority 893.055 FS. Law Implemented 893.055 FS. History–New 11-24-11, Amended 2-17-16, 1-12-17,              .

 

64K-1.007 Indicators of Controlled Substance Abuse.

(1) The following behavior indicates controlled substance abuse:

A patient who within a 90-day time period: (1) obtains a prescription for a controlled substance in Schedules II, III, or IV, as defined in section 893.055(1)(c) 893.03, F.S., from more than one prescriber; and (2) is dispensed a controlled substance in Schedules II, III, or IV, as defined in section 893.055(1)(c) 893.03, F.S., from five or more pharmacies.

(2) Upon identifying a patient who exhibits or for whom the behavior outlined in subsection (1), has been exhibited, the Program Manager may provide relevant information to the identified health care practitioners who have prescribed or dispensed controlled substances to the identified patient within the 90-day period.

Rulemaking Authority 893.055 FS. Law Implemented 893.055(2) FS. History–New 5-21-12, Amended             .

 

64K-1.008 Electronic Health Record System Integration

(1) Definitions.

(a) “Approved entity” means an eligible entity that has been approved by the department to connect an electronic health record system directly to E‑FORCSE®, the prescription drug monitoring data system.

(b) “Authorized user” means a health care practitioner as defined in section 893.055(f), F.S., or his or her designee.

(c) “Electronic health record” is an electronic or digital version of a patient’s medical history, maintained over time and may include all of the key administrative clinical data relevant to that person’s medical care under a particular provider, including demographics, progress notes, problems, medications, vital signs, past medical history, immunizations, laboratory data and radiology reports. The electronic health record uses computer hardware and software for the storage, retrieval, sharing and use of health care information and data.

(d) “Eligible entity” means an organization or entity that operates or provides or makes available an electronic health record system to a health care practitioner or a designee of the practitioner.

(2) An eligible entity may apply to the department to request and receive information directly from E‑FORCSE® through an electronic health record system by completing the following steps:

(a) Complete an Integration Request Form, DH8024-PDMP, effective 7/2018, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-####.

(b) Submit the Integration Request Form to the department.

(3) The department will review the submitted form and notify each applicant by email if the request to integrate is approved or denied.

(4) Eligible entities and authorized users may retain patient prescription monitoring information in the electronic health record and must ensure that the confidential and exemption information is not inadvertently released or accessed by unauthorized persons or entities.

(5) Only individuals authorized by sections 893.055 and 893.0551, F.S., who are active registered E‑FORCSE® users are authorized to request and receive information directly from E‑FORCSE® through an electronic health record.

(6) The department may suspend or revoke integration approval if an eligible entity or authorized user does not adhere to the department’s terms and conditions, including security and privacy requirements.  The department will immediately notify the approved entity or authorized user upon suspension or revocation of approval.

Rulemaking Authority, 893.055 FS.  Law Implemented 893.055(7) FS. History–New              .

NAME OF PERSON ORIGINATING PROPOSED RULE: Rebecca Poston, Program Manager, Prescription Drug Monitoring Program

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Celeste Philip, MD, MPH, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD:  July 31, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR:  June 21, 2018