The agency is proposing to amend the rule that defines “authorized person” and “kickback”.

AGENCY FOR HEALTH CARE ADMINISTRATION
Health Facility and Agency Licensing

RULE NO: RULE TITLE
59A-7.020: Definitions
PURPOSE AND EFFECT: The agency is proposing to amend the rule that defines “authorized person” and “kickback”.
SUMMARY: Revisions to specify the professionals authorized to order clinical laboratory tests and receive test results and to revise the definition of kickback so that the definition does not include laboratory personnel directly collecting specimens from kidney disease patients under certain circumstances.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
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: 483.051 FS.
LAW IMPLEMENTED: 483.041(7), 483.181, 483.245 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE,TIME AND PLACE SHOWN BELOW(IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):
DATE AND TIME: June 23, 2009, 1:30 p.m. – 4:30 p.m.
PLACE: Agency for Health Care Administration, Building 3, Conference Room B, 2727 Mahan Drive, Tallahassee, Florida
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 5 days before the workshop/meeting by contacting: Karen Rivera, Laboratory Unit, 2727 Mahan Drive, Building 1, Mail Stop 32, Tallahassee, Florida 32308, [phone]. 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: Karen Rivera, Laboratory Unit, 2727 Mahan Drive, Building 1, Mail Stop 32, Tallahassee, Florida 32308, [phone]

THE FULL TEXT OF THE PROPOSED RULE IS:

59A-7.020 Definitions.

(1) through (3) No change.

(4) Authorized Person – a person authorized by the laws of this State to order tests or receive test results or both including a medical doctor licensed under Chapter 458, F.S., a doctor of osteopathy licensed under Chapter 459, F.S., a chiropractor licensed under Chapter 460, F.S., a doctor of podiatry licensed under Chapter 461, F.S., an individual licensed in naturopathy under Chapter 462, F.S., an advanced registered nurse practitioner, including the category of certified nurse midwife, licensed under Chapter 464, F.S. and a dentist licensed under Chapter 466, F.S.

(5) through (14) No change.

(15) Kickback.

(a) through (f) No change.

(g) Provision of personnel or assistance of any kind to perform any duties for the collection or processing of specimens except:

1. Phlebotomist providing collection services in physician’s office to obtain blood samples for patients that are diagnosed with chronic kidney disease (CKD) and do not yet require dialysis and the testing preformed on the samples is either specific to the diagnosis of CKD, one of CKD’s co-morbid conditions, or otherwise ordered by the nephrologist, and not by any other physician or;

2. Such Ppersonnel or assistance is authorized to be provided on a temporary basis for the collection of specimens at a patient’s residence.

These collections must meet the requirements of Chapter 59A-7, F.A.C.

(16) through (34) No change.

Rulemaking Specific Authority 483.051 FS. Law Implemented 483.035, 483.041, 483.051, 483.106, 483.191 FS. History–New 11-20-94, Amended 8-13-95, 12-27-95, 6-22-06,________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Karen Rivera
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Secretary Benson
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: April 29, 2009
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: February 6, 2009