To provide for designee and impaired practitioner consultant access as required by legislation.

 

DEPARTMENT OF HEALTH

Prescription Drug Monitoring Program

RULE NO.:RULE TITLE:

64K-1.003Accessing Database

PURPOSE AND EFFECT: To provide for designee and impaired practitioner consultant access as required by legislation.

SUMMARY: The rule is being amended to provide for designee and impaired practitioner consultant access to the prescription drug monitoring database and to update and add necessary forms and training courses, as required by 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 or 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, FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca R. Poston, Program Manager, 4052 Bald Cypress way, Bin #C-16, Tallahassee, FL 32399-3250, 850-245-4797 or [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

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) “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.

(2)(a)(1) Pharmacists, prescribers and dispensers licensed in Florida may directly access the information in the program database by registering on the E-FORCSE® secure web portal at 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 “Training Guide for Florida Practitioners and Pharmacists,” DH8009-PDMP, effective 7/2016 1/2015, which is incorporated herein by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-#####06456 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 the database using a secure 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.

(3)(a) A designee of a prescriber or dispenser may directly access the information in the program database by registering on the E-FORCSE® secure web portal at 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 “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-#####, 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 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 “Training Guide for Florida Practitioners and Pharmacists.”  The linking process will require the prescriber or dispenser to certify that the designee has reviewed the “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.

(4)(a)(2) Entities that do not have direct access to 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 designee execute an “Agency User Agreement,” DH8017-PDMP, effective 7/2015, incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-06462. If approved, the program manager will execute and return the agreement to the agency.

(b)(3) After approval of the Agency User Agreement, eEach agency head or person appointed by the agency head for this purpose designee shall appoint an agency administrator with an “Agency Administrator Appointment Form,” DH 8010-PDMP, effective 1/2015, incorporated by reference and available at http://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)(4) 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 http://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 06/2016 1/2015, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-#####06458, and the “E-FORCSE® Information Security and Privacy Training Course, effective 7/2016 1/2015, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-#####06464. 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 through the secure E-FORCSE® web portal.

(e)(5) No change.

(6) Each agency head or designee shall immediately notify the program manager or support staff of a change in the agency administrator. The program shall suspend authority to request and receive information from the program database during an agency administrator vacancy.

(f)(7) No change.

(5)(a) Impaired practitioner consultants do not have direct access to 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 http://www.flrules.org/Gateway/reference.asp?No=Ref-#####.  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 http://www.flrules.org/Gateway/reference.asp?No=Ref-#####.  Prior to appointment, each authorized user must review the “Training Guide for Impaired Practitioner Consultants,” DH8021-PDMP, effective 7/2016, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-#####.  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 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 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 http://flrules.org/Gateway/reference.asp?No=Ref-#####, 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 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.

(6)(8) A patient or the legal guardian or designated health care surrogate of an incapacitated patient may request information from 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]. Requesters must complete form DH 2143, “Patient Information Request,” effective 6/2016 12/2010, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-#####00721. 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,             .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Rebecca R. Poston

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 12, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 18, 2016