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.

SUMMARY: This rule describes the requirements of the Florida Medicaid program for reimbursement of residual health care services when a recipient participates in a clinical trial.

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: A checklist was prepared by the Agency to determine the need for a SERC. Based on this information at the time of the analysis and pursuant to section 120.541, Florida Statutes, the rule will not require legislative ratification.

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: 409.919 FS.

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

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

DATE AND TIME: February 5, 2016, 10:30 a.m. ‒ 11:30 a.m.

PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building 3, Conference Room D, 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 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 February 8, 2016.

 

THE FULL TEXT OF THE PROPOSED RULE 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) Are covered under the Florida Medicaid program.

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

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

(d) Are not expected or unique to the experimental or investigational treatment.

(e) 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 ________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Kathleen Core

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Elizabeth Dudek

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 28, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: November 5, 2015