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CLIA Failure to Notify Re Renewal Dates

The Florida Obstetric and Gynecologic Society wishes to make you aware that the Florida Agency for Healthcare Administration, in a measure to meet increasing budgetary constraints, has moved forward with a plan to issue renewal notifications on various licensures only where statutorily mandated. Presently, the most pressing effect of this decision is that State Issued clinical lab licenses are not subject to renewal notication requirements. The information contained below is excerpted from some correspondence between FMA representatives and the Florida AHCA, so that you can follow the progress of this matter and what the Florida Medical Association is doing about it.

-----Original Message-----
From: Plendl, Francie
Sent: Monday, October 13, 2003 4:24 PM
To: CMS Executives; Specialty Society Execs
Subject: FW: CLIA failure to notify re renewal dates

CMS Executives and Specialty Society Executives:

Many of you are getting inquiries from members about notices they have received from AHCA regarding their State issued (not Federal) clinical lab licenses. Below this email is an email containing information that I have received from AHCA on the subject.

We are in the process of asking AHCA to consider allowing those physicians who inadvertently allowed their state clinical lab license to lapse to go through the renewal process rather than apply for a new license. We will keep you up to date on this request, but physicians should be advised that they should not operate their lab without a current license.

FYI, in November of 2002 AHCA sent notices (copy attached) to all labs stating that they would not be sending out renewal forms. The physician was asked in the letter to access the renewal forms from the AHCA website.

In March of 2003, the FMA wrote a letter to AHCA asking them to reconsider their decision not to send renewal forms to physicians. In April of 2003, AHCA responded to the FMA (copy attached), stating that they would send a one time letter 60 to 90 days prior to the expiration of the license, but would not send any more notices.

In the January 3, 2003 issue of the Enews Weekly, the FMA ran the following:

IMPORTANT NOTICE REGARDING RENEWAL OF YOUR LABORATORY LICENSE
Effective January 1, 2003, the Agency for Health Care Administration (AHCA) will cease sending renewal reminder notices or renewal applications not required by statute. Rather than waiting for receipt of a licensure renewal package, providers are requested to obtain the renewal forms from the Agency's website http://www.fdhc.state.fl.us/MCHQ/Health_Facility_Regulation/Laboratory/index.shtml. Click on the appropriate facility or provider type, and that will take you to the forms needed for your renewal application. The forms must be downloaded for completion, as they require signatures and accompanying renewal payments. Completed forms cannot be transmitted electronically. Renewal applications should be received by the Agency at least 60 days before the date on which the license is due to expire. Substantial fines may be levied by the Agency for operating without a valid license. In order to expedite future communications, AHCA is requesting that you submit your e-mail address to the AHCA Laboratory Unit at 2727 Mahan Drive, Mail Stop # 32,Tallahassee, FL 32308. If you have questions about this notice, you may contact the AHCA Laboratory Unit at 850.487.3109.

Unfortunately, many physicians did not renew their clinical laboratory license and are now having to go through the relicensure process. We will do what we can to have AHCA reconsider having these physicians apply for a new license.

Francie Plendl
FMA Director of Governmental Affairs

-----Original Message-----
From: James, Patricia
Sent: Monday, October 13, 2003 3:27 PM
To: Plendl, Francie
Cc: Dudek, Liz
Subject: RE: CLIA failure to notify re renewal dates

Dear Francie,

It is always a pleasure to assist you and your members with their problems and questions. I hope the following information is useful both to you and to them.

As background information for you, I have attached the body of the letter that we have been sending out to all the licensed labs regarding the decision to no longer send courtesy renewal applications for all of the licensure programs administered by the Agency unless those notices were required by statute. The Laboratory Licensure Program has no such renewal notification requirement. I have also attached a letter that Dr. Medow's sent to Dr. Cline in April of this year.

ed.[ Dr. Cline's intial letter to Dr. Meadows is available here.]

The letter we have been sending out to the individual labs are mailed at least 60-90 days before the expiration of the existing license, and indicate that no future notification will be provided. Overall, we feel these letters have worked in getting the word out about this change, since 2/3 of the licensees to whom the letter was sent have renewed before their expiration date.

Please let your members know that the letters they are currently getting indicating that their laboratory license has expired pertains to the State of Florida Clinical Laboratory Licensure Law pursuant to Chapter 483, Part I, Florida Statutes. It does not pertain to their federal Clinical Laboratory Improvement Amendments (CLIA) certificate issued by the Centers for Medicare and Medicaid Services (CMS). An easy way to determine which certificate is which is to look at the certificate/license number. The State of Florida licenses will begin with L 8000XXXX. CLIA certificates issued for Florida begin with 10D-XXXXXXXXX.

The fees for the Florida lab licenses are found in s. 483.172, and are summarized as follows:

Some labs are also required to pay the Agency's annual facility fee assessment and the PMAFT fee. These fees are often confused with the laboratory licensure fee or the CLIA fee.

If there are any other questions that your or your members may have, please have them contact us here in the Laboratory Unit. The Laboratory Unit is experiencing a very high number of phone calls right now, so we ask your members' patience in any delays they may experience.