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- March 2014
In 2010, the NADL’s analysis of the new healthcare legislation revealed that a 2.3% excise tax would be applicable to the selling price of completed dental restorations beginning in 2013.
Vague terminology in the legislation indicated that the 2.3% tax would be payable by the manufacturer, producer or importer but didn’t specifically define those terms. Given the FDA’s previous classification of dental laboratories as medical device manufacturers, the conclusion was that the tax would apply.
The news generated a growing alarm over the next several months as laboratory owners sought clarification on what the tax would mean to them. Despite the efforts of the NADL, ADA and nearly a dozen other allied dental organizations to have dental devices excluded from the tax, the IRS denied the request at a public hearing in Washington D.C. in May 2012.
However, at virtually the last minute—on December 4, 2012—the IRS released its Final Rule on the Medical Device Tax,...
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- April 2013
All-ceramics, implants, profit erosion and other hot topics inspired dialogue during the biggest weekend of the year.
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At the Cal-Lab Meeting in Chicago, Safelink's Gary Morgan, CDT, offered an update on various regulatory issues, including OSHA, the FDA and the Medical Device Tax. Here's an overview:
OSHA has revised its Hazard Communication Standard. "This is a major change you need to be aware of and address right now," said Morgan, noting that OSHA is making enforcement a priority and laboratory inspections and penalties are on the rise. As part of the new standard:
Laboratories must update their hazard communication plan which details how staff should safely work with chemicals. "You need to figure out what you have: conduct an assessment, determine safe practices, create a written program and label all chemicals with their contents," said Morgan.
OSHA has also adopted a Global Harmonization System (GHS) that requires images or pictograms on dangerous, corrosive or toxic substances. Manufacturers and distributors are required to label original containers and the lab should either provide the same...
- October 2012
It would be downright silly to suggest anyone actually likes taxes so itâs no surprise that a coalition of 400 medical device manufacturers voiced its opposition to the 2.3% excise tax on medical devices slated to go into effect January 1, 2013.
- August 2012
2.3% Excise Tax Goes into Effect in 2013; FDA Registration Fees Increase
Since the Health Care and Education Reconciliation Act was signed into law in May 2010, laboratory owners have been wondering whether the 2.3% excise tax on medical devices applies to dental restorations. Despite the efforts of the U.S. House of Representatives, NADL, ADA and nearly a dozen other allied dental organizations to have dental devices excluded from the tax, the IRS denied the request at a public hearing in Washington D.C. in May. "Effective January 1, 2013, it's prudent for dental laboratories to be prepared for remitting a 2.3% excise tax on sales of finished devices," says Bennett Napier, CAE Executive Director, NADL.
According to an analysis by Reed Smith, LLP, the NADL's Washington, D.C.-based law firm:
- The tax applies to the finished device rather than components. For example, if Laboratory A outsources a partial framework to Laboratory B, there would be no tax due on the transaction. The tax only...
During the "boom" years of the late 1990s-2008, lab fees made significant gains; in a number of cases, they caught up with or even exceeded the Consumer Price Index. It's not like the lab community has ever measured its fees against cost of living increases but, for the sake of observation, when LMT began tracking lab fees back in the 1980s, we sometimes looked at the rate of inflation as a sort of measure to record growth.
We are now on the cusp of year five since the economy went bust. As you will read in this issue's biennial Wage Report and next month in our Fee Report, the sense of being squeezed is making our headlines. Many laboratories report they are holding tight to old fee schedules and have also had to cut back on technician work hours. Once again, we are hearing a familiar story. Here's an excerpt from LMT's 1991 Wage and Price Survey Report:
" . . . Many laboratories can't afford to pay higher salaries because their price schedules are too low—in fact, many prices...
- April 2011
The NADLâs analysis of the new healthcare legislation reveals a 2.3% excise tax applicable to the selling price of completed dental restorations.
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While the FDA is paying unprecedented attention to the dental laboratory industry, only half of laboratory owners and managers are familiar with the agencyâs Good Manufacturing Practice requirements.
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