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November 20, 2008
Dear Licensed Practitioners and Facility Owners:
Did you know that O&P facilities in Texas ARE NOT EXEMPT from the FDA Medical Devices Distributor license requirements and fees?
The collective executive boards of the TAOP and TCAAOP need your help to fight this impending additional fee and are spearheading a collaborative effort by forming the Texas O&P Alliance, in order to affect a positive change for EVERY O&P facility in Texas.
While this situation has been brewing for some time, we believe the time has come to take action. Many of you have heard the isolated stories of random independent facilities being subjected to this license, however, AS YOU ARE READING THIS, Tom Brinck, Director of the TDH Drugs and Medical Devices Division, is making plans within his division to start contacting O&P facilities around the state to force compliance with this regulation.
After several discussions with the Executive director of the TBOP, David Olivera, it has been determined that, in his opinion , we are not exempt from TDH Drugs and Medical Devices regulatory action under the Texas Administrative Code - and will continue to be subject to its fees and regulations unless there is a change in our statute. (You should be checking the TBOP website, as they are planning on publicly posting this position in the coming weeks.)
Without action we face the very real possibility of being regulated by a second licensing board: paying the associated fees and complying with its statues. Please see the attached fee schedule under the Texas Administrative Code. (Attachment A).
Several interested parties attended the last TBOP meeting on Friday October 17, 2008. These persons represented a wide variety of professionals and professional perspective in our industry: independent O&P facility owners, a corporate O&P representative, and the Executive board members the TAOP and TCAAOP. Following the TBOP meeting we gathered to formulate a plan to deal with this situation. The following are strategies adopted subsequent to that meeting:
Strategy to accomplish governmental affairs and objectives:
1. Change the Language of our Statute: Seek the introduction of a statutory change by the Texas Legislature that would expressly exempt Individuals/entities licensed under Chapter 605 of the Texas Occupations Code from also being required to be licensed under Chapter 431 of the Texas Health and Safety Code;
2. Change the Language of the FDA Statute: Work to ensure passage of the proposed statutory exemption to Chapter 431 of the Texas Health and Safety Code; and
3. Grassroots Activism: Work with appropriate Texas officials to attempt to prevent any new licensing requirements under Chapter 431 from being imposed prior to the Texas Legislature convening.
CALL YOUR STATE REPRESENTATIVE AND OBJECT TO THIS DOUBLE TAXATION/REGULATION FOR O&P
Go to www.fyi.legis.state.tx.us to find out who your representative is
The Executive Boards of both TCAAOP and TAOP have contracted with Hillco, a reputable lobbying firm who can help facilitate this effort. The estimated cost for affecting a change in two statutes (O&P/FDA) is $125,000. The Executive Boards of the TCAAOP and TAOP have pledged to split the cost in a good faith measure, as this victory will benefit our memberships and every O&P professional in Texas.
Now, we need you to do your part. We are asking every facility owner in the state of Texas to donate $2,000 dollars PER LICENSED LOCATION to this cause and every practitioner to donate as they can. Since these funds are earmarked for Legislative change- as opposed to a PAC fund contribution, they may be able to be remitted from your company’s business account. (Please consult with your CPA to determine this feasibility.)
This is an important and worthy effort with significant impact relating to the industry’s earning potential. In the age of federal healthcare cutbacks, managed care and decreasing reimbursement- we need every licensed individual to participate as they are able - NOT just facility owners.
The TCAAOP and TAOP Boards are looking forward to working together under the Texas O&P Alliance umbrella to resolve this pending crisis and look forward to the opportunity of representing our field with ONE UNIFIED VOICE.
There will be an informal informational session for those who have contributed prior to the TBOP’s scheduled Rules Change meeting, January 20th, 2009.
Should you have any questions, please feel free to contact the President of TCAAOP and/or TAOP, or any executive board member from either, to obtain additional information regarding this special alliance project.
In addition, if you have specific questions relating to this letter and special project, you may contact TAOP’s Vice President, Mark Kirchner, CPO/LPO and Texas O&P Alliance liaison directly at the following:
Mark Kirchner, CPO/LPO
TAOP Vice President
MK Prosthetic and Orthotic Services
4319 Medical Dr, Suite 106
San Antonio, Texas 78229-3325
Phone: (210)614-9222 Fax: (210)614-9333
Email: mkirchner@mkprosthetics.com
If you would like to stay connected to the Texas O&P Alliance, TAOP has added a special link that will be updated frequently @ www.taop.org. Also, please complete the attached form and check the email and/or fax box if you would like to receive updated news relating to this project.
As always, we appreciate your prompt attention to this critical project and look forward to your prompt response and contribution.
Sincerely,
Shawn Thomas David Telford
TAOP Board President TCAAOP Board President
/encl.
Attachment A
Texas Administrative Code –Chapter 229 –Excerpt from: http://info.sos.state.tx.us/pls/pub/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=25&pt=1&ch=229&rl=439
(a) License fee.
(1) No person may operate or conduct business as a device distributor without first obtaining a license from the department. All applicants for a device distributor license or a renewal license shall pay a licensing fee. All fees are nonrefundable. Licenses are issued for two-year terms. A license shall only be issued when all past due fees and delinquency fees are paid. License fees are based on gross annual device sales.
(A) For a distributor with gross annual device sales of $0 - $499,999.99, the fees are:
(i) $480 for a two-year license;
(ii) $480 for a two-year license that is amended due to a change of ownership; and
(iii) $240 for a license that is amended during the current licensure period due to minor changes.
(B) For a distributor with gross annual device sales of $500,000 - $9,999,999.99, the fees are:
(i) $1,080 for a two-year license;
(ii) $1,080 for a two-year license that is amended due to a change of ownership; and
(iii) $540 for a license that is amended during the current licensure period due to minor changes.
(C) For a distributor with gross annual device sales greater than or equal to $10 million, the fees are:
(i) $1,680 for a two-year license;
(ii) $1,680 for a two-year license that is amended due to a change of ownership; and
(iii) $840 for a license that is amended during the current licensure period due to minor changes.
Possible examples:
Example A - 2 yr old company with <499k sales. 480(past 2yrs) + 480 current fee = $960
Example B - 6 yr old company with >500k & <10 mil sales, 1080 X 3 plus current fee = $4320
Example C - 10 yr old company with >10mil sales the past 4 yrs. 3240 + (1680 X 2) + 1680+ $8280
FIND OUT MORE...CLICK ON THE LINKS BELOW!
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