To encourage responsible prescribing by implementing provisions to help establish a limited access comprehensive electronic database system for controlled substances.

DEPARTMENT OF HEALTH
Prescription Drug Monitoring Program

Rule No.: RULE TITLE
64K-1.001: Patient Advisory Alerts and Reports
64K-1.003: Accessing Database
64K-1.004: Management and Operation of Database
64K-1.005: Storage and Security of Information
64K-1.006: Program Evaluation and Other
PURPOSE AND EFFECT: To encourage responsible prescribing by implementing provisions to help establish a limited access comprehensive electronic database system for controlled substances.
SUMMARY: These rules provide a framework for the administering of the program and include advisory alerts and reports, access and operation of the database, breaches in security, and program evaluation.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: The agency has determined that this rule will have an impact on small business. A SERC has been prepared by the agency. The SERC indicates that electronic transfer of information is not unusual, particularly with regard to controlled substances, and that the electronic transfer of information requirement should not be unduly burdensome.
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.
SPECIFIC 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 FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Lucy Gee, Division Director, 4052 Bald Cypress Way, Bin #C00, Tallahassee, Florida 32399-3250

THE FULL TEXT OF THE PROPOSED RULE IS:

64K-1.001 Patient Advisory Alerts and Reports.

(1) An advisory report is an electronic screen containing information regarding a patient based on controlled substance information that has been reported to the Prescription Drug Monitoring Program (Program) database. The Program will update the advisory reports at least once a week and the information on the reports shall be removed when older than 60 days. Advisory reports will be issued in accordance with Section 893.13(7)(a)8., F.S. when recommended by law enforcement or by a board governing health care practitioners.

(2) An advisory alert is a report containing information that indicates that a patient may have been prescribed or received controlled substances in a strength, amount, or at a frequency that may be of concern to the patient or to any involved pharmacies and practitioners. When an alert is issued, the screen or report shall contain the phrase “ADVISORY ALERT” in distinguishing or colored font. The alert report shall be retained for a minimum of six months and until at least six months have passed during which time the patient has not been prescribed or received controlled substances in a strength, amount, or at a frequency that may be of concern to the patient or to any involved pharmacies and practitioners.

(3) An advisory report will only be provided to the practitioner, pharmacy, pharmacist, or patient upon request. When an alert report is created, a confidential alert notification will be e-mailed to the referenced practitioner or pharmacy with instructions on how to request and access the alert report.

Rulemaking Authority 893.055 FS. Law Implemented 893.055 FS. History–New_________.

 

64K-1.003 Accessing Database.

(1) The following entities have direct access to the information contained in the Program central database:

(a) A pharmacy, prescriber, or dispenser if the information relates to a patient of that pharmacy, prescriber, or dispenser for purposes of reviewing the patient’s controlled substance prescription history. Those entities who prescribe or dispense controlled substances, Schedules II-IV, and are registered in the Program system, may access the database through the secure web portal to request and receive information electronically, or may submit a written request to the Program manager if information must be received by an alternate means.

(b) The Program manager and designated Program support staff acting at the direction of or as authorized by the Program manager for purposes of management of the Program database and in furtherance of the Program.

(2) The following entities do not have direct access to the information in the database, but may request access from the Program manager or authorized staff:

(a) The Department or the heath care regulatory boards when involved in a specific controlled substance investigation involving a designated person for one or more controlled substances.

(b) The Attorney General or designee for Medicaid Fraud cases involving prescribed controlled substances.

(c) A law enforcement agency during an active investigation regarding potential criminal activity, fraud, or theft relating to controlled substances.

(d) A patient or the legal guardian or designated health care surrogate of an incapacitated patient as described in Section 893.0551, F.S., who, for the purpose of verifying the accuracy of the database information, submits a notarized request on a form authorized by the Program. To receive the requested information, the patient or representative must appear in person at the Program office and produce proof of representation if not the patient as well as a valid government issued photographic proof of identity.

(3) The Program manager or designated staff must ensure that the entity requesting access to information is permitted by law to receive access and must take every reasonable precaution to verify the request as authentic.

Rulemaking Authority 893.055 FS. Law Implemented 893.055 FS. History–New_________.

 

64K-1.004 Management and Operation of Database.

(1) All entities that dispense controlled substances, Schedules II-IV, are required to report to the Program central database. These entities include:

(a) Any pharmacy with a permit issued under Chapter 465, F.S., that dispenses controlled substances, whether located in or out of the State of Florida, including mail order or internet pharmacies.

(b) Any health care practitioner, practicing in Florida, who dispenses any controlled substances, Schedules II-IV, and who is licensed under Chapter 458, 459, 461, 462, or 466, F.S.

(c) Exemptions from reporting are as stated in Section 893.055(5), F.S.

(2) All entities that dispense controlled substances, Schedules II-IV, must register with the Program prior to submitting data.

(3) All dispensers will electronically report data to the Program’s database not more than 15 days after the controlled substance is dispensed according to a schedule developed and published by the Program. Extensions of the time within which a dispenser must report the dispensing of a controlled substance shall be granted for no more than 30 days upon request to the Program by any dispenser unable to submit data by electronic means for good cause 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 the central database is unable to receive submissions.

(4) Data not accepted by the database system due to a substantial number of errors or omissions shall be corrected and resubmitted to the database by the reporting dispenser within five days of receiving written notice that the submitted data was unacceptable.

(5) Failure to report the dispensing of Schedules II-IV controlled substances will result in the Program filing a complaint for investigation by the Department and a referral to law enforcement.

(6) All information from the database disseminated in any form by the Program to any entity is considered protected health information and the use of it is governed by any and all applicable federal and state laws. Authorized entities receiving such information shall maintain the information for up to 24 months before purging it from the records or shall maintain it for longer than 24 months if advised that the information is pertinent to an ongoing disciplinary or law enforcement investigation or prosecution.

(7)(a) A patient, health care provider, prescriber, or dispenser is authorized to submit to the Program an electronic request for the correction of erroneous information in the database. The request shall include:

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

2. The precise change requested;

3. Documentation establishing the error and 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 will review all requests to correct information in the database and will contact the entity that provided the data under review. If the reporter of the data concurs that the data should be corrected as requested, the Program will make the correction. If the reporter does not agree, the correction will not be entered. The entity requesting the correction will be notified of the Program’s determination.

Rulemaking Authority 893.055 FS. Law Implemented 893.055 FS. History–New_________.

 

64K-1.005 Security of Information.

Breaches in security discovered by the Program manager must be reported to the Department and to law enforcement within one business day of discovery of the breach. System users who become aware of a breach in security must report the suspected breach to the Program manager or Department as soon as possible or no later than one business day after its discovery.

Rulemaking Authority 893.055 FS. Law Implemented 893.055 FS. History–New_________.

 

64K-1.006 Program Evaluation and Other.

Beginning in October 2011, the Department shall evaluate the Program to prepare a report to the Legislature and Governor by December 1 of each year using the performance measures specified in Section 893.055(8), F.S.

Rulemaking Authority 893.055 FS. Law Implemented 893.055 FS. History–New_________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Lucy Gee
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Ana M. Viamonte Ros, M.D., M.P.H.
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 30, 2010
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: March 12, 2010