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LEGISLATIVE HOUSE UPDATE
Despite the efforts of the Legislative Committee, House Bill 3371 - to exempt registered dental laboratories from certain distributing and manufacturing licensing requirements failed to get a vote.
Efforts will be made again at the next session.
HB 3371 SENT TO SENATE!
May 13, 2011
Congratulations to the DLAT Legislative Committee. The House Bill was passed by the House today and is now in the Senate and has been sent to the Health and Human Resources Committee for review!
UPDATE
May 5, 2011
House Bill 3371 was passed out of committee at 10:47 pm, Thursday night, without any no votes and was sent to the Local and Consent Calendar.
LEGISLATIVE HOUSE HEARING
May 4, 2011
Good news on the legislative front. Elyese Anderson, Larry Mercadel, Ernest Cardenas, Gary Box, Gary Morgan, Andre LuJan, and Milton Pokladnik met in Austin at the State Capital at 7:30 am, Wednesday, May 4, for an 8:00 am hearing on House Bill 3371 - to exempt registered dental laboratories from certain distributing and manufacturing licensing requirements. As legislation typically goes, the House Committee met until 10:00 am, then recessed to go into business on the House floor. That session lasted until 10:00 pm, Wednesday night. DLAT testimony was finally presented at 10:30 pm. Larry led off, Elyese presented her testimony, and Milton closed. The Health Committee gave all indications of support and Legislative Aide Brian Long said they would push to get it to the Senate. One scare came as the State Department of Health presented resource testimony, but it ended up being a favorable asset to our position. The Dallas contingent got home about 3:00 am Thursday morning.
Sherry Meeks, Executive Director for the Texas State Board of Dental Examiners, was present as a resource witness
What A Day!
Milton C. Pokladnik, CDT, Ret.
Executive Director
Dental Laboratory Association of Texas
82nd LEGISLATURE
DLAT's bill to exempt dental laboratories in the State has been introduced by Representative Susan King of Abilene. House Bill 3371.
Also, a bill has been introduced by Senator Dan Patrick of Houston to consolidate under one agency all State Agencies that regulate Health Professions.
Senate Bill 1785.
A bill has also been introduced by Representative Sid Miller of Stephenville to regular Equine Dental Technicians. House Bill 3637.
NOW IS THE TIME TO SUPPORT YOUR LEGISLATIVE COMMITTEE
WITH CONTRIBUTIONS FOR LOBBYING EXPENSES!
Please see Legislative Update - Informative Letters from Gary D. Morgan, CDT.
For more information and to make a contribution, contact
Milton C. Pokladnik, CDT, Ret.
Executive Director
Dental Laboratory Association of Texas
1.877.689.8848
aurex@swbell.net
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Blue Ribbon Committee
of
The Dental Laboratory Association of Texas
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To study current challenges to DLAT, a Blue Ribbon Committee was formed at the Board of Directors Meeting in Austin on May 15, 2010. The purpose is to learn of new ways to increase the Association’s membership, to improve DLAT’s role in education of dental lab owners and technicians, and to increase its role of influencing legislation affecting the dental industry in Texas. Duties are for members to meet with Committees within DLAT, industry representatives, and the various Study Clubs in Texas.
The dental industry is destined to undergo more changes and challenges, and the Association must respond. The Committee is to make recommendations to the DLAT Board of Directors within a year.
Your suggestions or comments may be made to any of the Committee members listed below.
Ernest Cardenas, CDT, Chairman cardenas.e@sbcglobal.net
Cade Tippett, BS, CDT cadetippett@gmail.com
Brenda Triplett, BBA, CDT btrip003@sbcglobal.net
Tim Whatley, CDT tim@ods2dds.com
Keith Wilson, BA kwilsongold@verizon.net
 Futures / Visionary Committee
Chairman Cade Tippett, BS, CDT
cadetippett@gmail.com
This committee is challenged with the purpose to develop a vision for the future of DLAT and serve as a resource for future leadership. Areas for involvement are education, image, policies and procedures, resources, growth, etc. Member criteria includes: technicians/employees with minimum of 3 years experience and an age range of 20-40 years. A limited number of affiliates are encouraged to participate.
Focus groups within the Committee will meet as necessary, but the entire committee must convene at least annually for purpose of reporting to the DLAT Board of Directors.
To learn more and to help shape the future of DLAT, contact Cade Tippett.
Click to see Table of Contents to Introduction to a Quality System
National Health Insurance Reform and Its Impact
on
Dental Laboratories
Analysis provided by Jennifer Goldstein, Esquire, Reed Smith,
LLP and NADL Executive Staff
Individuals and small businesses will all be impacted indirectly or directly by the recent passage of new law as it relates to fees and taxes. NADL has looked at one of the key provisions in the health care reform legislation to determine any direct impact on dental laboratories.
Part of the new law, referred to as the Patient Protection and Affordable Care Act ("PPACA") [1], as amended by the Health Care and Education Reconciliation Act of 2010 ("Reconciliation Act") includes an excise tax on the price for which a finished medical device is sold.
Dental laboratories customize or manufacture crowns, bridges, and other dental products based on a prescription from a licensed dentist. These dental products, which include prosthetic devices (e.g., denture teeth and implants) and therapeutic devices (e.g., orthodontic devices) are regulated as medical devices by the Food and Drug Administration (FDA), [2] and are subject to FDA’s good manufacturing practice (“GMP”) and quality system (“QS”) requirements, but in most cases are exempt from manufacturer registration requirements.[3]
The Reconciliation Act amends certain provisions of the PPACA and represents the final version of those provisions that were signed into law. The Reconciliation Act includes an excise tax on all medical devices, with some exceptions.[4] Specifically, Section 1405 of the Reconciliation Act adds Section 4191 to Chapter 32 of the Internal Revenue Code, and imposes a tax on the sale of any “taxable medical device” by the “manufacturer, producer, or importer” of the device.[5]
The tax is 2.3 percent of the price for which the device is sold.[6] A “taxable medical device” is defined as any device that meets the FDCA definition of “medical device,” excluding eyeglasses, contact lenses, hearing aids, and other medical devices the Secretary of U.S. Health and Human Services determines to be one which is generally purchased retail by the general public for individual use.[7] The excise tax provisions apply regardless of the classification of the device.
The Reconciliation Act does not define “manufacturer, producer or importer.” Since the Reconciliation Act uses the FDCA definition of “device,” we can consider the FDCA definition of “manufacturer, producer, |
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or importer” for insight into how those terms might be defined in application of the tax provisions of the Reconciliation Act.FDA defines a medical device manufacturer as “any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure.”[8] While the FDCA and implementing regulations do exempt dental labs from some requirements applicable to manufacturers, dental laboratories are considered by FDA to be manufacturers.
In summary, the key impacts and points to remember on this new law as it relates to dental laboratories are as follows:
- All dental laboratories will be subject to paying a 2.3% tax on annual sales of medical devices starting in 2013.
- The tax will be on the sale of the finished device rather than components. For example, if Laboratory A outsources the manufacture of a component part such as a partial framework to Laboratory B, there would be no tax due on the transaction for the partial framework. The 2.3% excise tax would be on the sale and price of the finished device, at the point that Laboratory A ships or delivers the finished device to the prescribing dentist.
- With regards to imported medical devices, the tax applies to the importer. In the case of a foreign dental laboratory which provides a finished device to a domestic dental laboratory or dentist, the tax applies to the importer, which may the U.S. agent for the foreign dental laboratory. FDA requires that all foreign manufacturers designate a U.S. agent in order to be able to import medical devices into the United States.
- The tax goes into effect in 2013 and applies to sales of medical devices after December 31, 2012.
The IRS will be developing implementing regulations within the next two years to provide guidance to businesses on how the excise tax will be collected and the frequency of tax reporting and submission. The NADL will continue to provide information to its members and the industry as further government guidance is developed prior to the effective date of the new law.
[1] Public Law No. 111-148.
[2] 21 CFR Part 872.
[3] 21 CFR 807.65(j).
[4] Sec. 4191(d).
[5] Sec. 4191(a).
[6] Id.
[7] Sec. 4191(b).
[8] 21 CFR 803.3, Medical Device Reporting; and
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CFR 807.3, Establishment Registration and Device Listing |
Procedures for Clinic Attendance Verification for CE Credit
 The National Board for Certification is now utilizing bubble
sheet technology
to track NBC Continuing Education credits.
Upon entry into each clinic, CDTs
and
RGs will
obtain a
scan card.
1. Your name and address must be clearly printed in the upper portion of the scan card
in the boxed area.
2. The lower portion of the card provides two boxes.
3. You will “bubble in” your complete CDT/RG number in the box on the left and a special
course number in the box on the right.
4. The course number will be provided.
Important ... the scan cards must be filled out with a No. 2 pencil. Do not use ink, ballpoint, or felt tip pens.
Any cards that are not bubbled in completely and correctly cannot be recorded. If your CDT or RG number begins with one or more zeros, you must mark those bubbles. Do not fold, bend, tear, staple, or moisten the scan card.
You must sign the card, which is to certify that the course number claimed is the actual course attended. You must leave the completed cards in the classroom before you exit. The scan card cannot be faxed or mailed to the NBC by the individual.
Be sure to take your Clinic Confirmation to retain in your records for possible future reference.
FYI Links ... FYI Links ... FYI Links
The latest "Must Know" information from the Texas State Board of Dental Examiners!
... submitted by Gary Morgan, CDT.
Important legal information for anyone interested in Offshore Outsourcing
... submitted by Moore Marketing & Sales.
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