The purpose of Rule 59G-1.036 is to specify coverage policy when a recipient requires Florida Medicaid compensable services as a result of participating in a clinical trial.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Medicaid

RULE NO.:RULE TITLE:

59G-1.036Clinical Trials

PURPOSE AND EFFECT: The purpose of Rule 59G-1.036, F.A.C. is to specify coverage policy when a recipient requires Florida Medicaid compensable services as a result of participating in a clinical trial.

SUBJECT AREA TO BE ADDRESSED: Rules 59G-1.036, F.A.C., Clinical Trials and 59G-1.05, F.A.C. 7, Telemedicine.

An additional area to be addressed during the workshop will be the potential regulatory impact Rules 59G-1.036 and 59G-1.057, Florida Administrative Code, will have as provided for under sections 120.54 and 120.541, Florida Statutes.

RULEMAKING AUTHORITY: 409.919 FS.

LAW IMPLEMENTED: 409.902, 409.905, 409.906, 409.907, 409.908, 409.912, 409.913 FS.

A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: November 20, 2015, 10:00 a.m. ‒ 11:30 a.m.

PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building 3, Conference Room C, Tallahassee, Florida 32308-5407

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 48 hours before the workshop/meeting by contacting: Kathleen Core. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Kathleen Core, Bureau of Medicaid Policy, 2727 Mahan Drive, Mail Stop 20, Tallahassee, Florida 32308-5407, telephone: [phone], e-mail: [e-mail]. Comments will be received until 5:00 p.m., on November 23, 2015.

 

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

 

59G-1.036 Clinical Trials.

(1) This rule applies to any person or entity prescribing or reviewing a request for Florida Medicaid covered services and to all providers of Florida Medicaid covered services who are enrolled in or registered with the Florida Medicaid program.

(2) Definitions. Clinical Trials - Biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison.

(3) Coverage. Florida Medicaid reimburses for services as a result of a recipient participating in a clinical trial in accordance with the service-specific coverage policy when the services:

(a) Would otherwise be provided to a recipient who is not participating in a clinical trial.

(b) Are related to complications or side effects arising during the clinical trial.

(c) Are not expected or unique to the experimental or investigation treatment.

(d) Are not covered by the clinical trial sponsor.

Rulemaking Authority 409.919 FS. Law Implemented 409.902, 409.905, 409.906, 409.907, 409.908, 409.912, 409.913 FS. History-New ________.