Medical Device Excise Tax

On April 30, 2013, all eligible medical device manufacturers or importers must pay medical device excise taxes for the first three months of 2013.

• Is your firm or product line eligible?
• Do you qualify for exemptions?

There are several possible exemptions and tests to avoid or minimize the tax. They include:

• Retail – including purchase tests, use tests and design tests
• OTC safe harbor
• Durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) safe harbor
• Further manufacturing
• Export

Then there is the pesky issue of how to calculate the sales price to determine the taxes due. IRS Notice 2012-77 notes five different scenarios for calculating sales price. Which one applies to you?

In addition, the IRS has the right to audit and expects you to be able to justify your eligibility and exemption choices – and provide documented evidence to back up your stance. Are you ready?

Medical Device Excise Tax: Practical Answers to Eligibility, Exemptions, Pricing and Compliance Tax Answers for Non-Tax Professionals, a FDAnews webinar, will be on Tuesday, March 12, 2013 – 1:30 p.m. - 3:00 p.m. EST.

The Medical Device Excise Tax has been one of the most controversial policies to affect the industry in decades. However, the pain can be mitigated if you properly apply the exemptions provided and document your actions. FDAnews, in conjunction with medical device tax expert Dan Lynn, has created your personal pain management plan. In just 90 minutes, Lynn will walk attendees through each element of the tax calculation. He will guide you through six major questions everyone is asking:

1. What companies are subject to the tax and why?
2. How does the IRS determine what is a taxable product and what is not – some of the answers will surprise you!
3. Exemptions, exemptions, exemptions; how can I legally exempt various products from the tax?
4. If my products do apply, how do I determine the constructive sales price and  when should I use it; underpaying this tax is definitely not recommended.
5. Avoiding compliance woes – have I properly registered my company and  product lines, what about selling to sister companies, or where do I send the money and how?
6. What about quirky stuff like combination products and kitting/convenience kits – what is up with them?

Your colleagues and competitors have already started this painstaking process. Do not delay. Register now and mark your calendar Medical Device Excise Tax: Practical Answers to Eligibility, Exemptions, Pricing, and Compliance on March 12, 2013. 

Attendees to Medical Device Excise Tax will:

• Develop a basic understanding of the tax, with myths about the tax being debunked
• Determine if your company is subject to the tax
• Understand the seven triggers that subject a company to the tax
• Learn best practices and suggested models for evaluating your products for inclusion/exclusive of tax eligibility
• Be able to determine if the retail exemption or facts and circumstances  tests apply to your products
• Be confident in your understanding of the OTC exemption; including applying the FDA’s online IVD Home Use Lab Tests database or device registration  and listing database
• Determine if the IRS considers your product a DMEPOS and can you exempt yourself
• Understand Form 637 Activity Letter B and Activity Letter D and whether your product applies for further manufacturing and export exemptions
• Feel confident in exempting yourself for contributions of devices to charitable organizations
• What documentation is needed to provide “reasonable” support for exemptions in order to avoid potential IRS penalties for misclassification
• What evidence does the IRS expect you produce to justify further manufacturing or proof of export exemptions
• Understand “constructive sales price” for products that are sold directly to retailers, hospitals, and physician groups
• Learn when to use the actual sales price versus the constructive sales price
• If your taxable sales exceed $108,700, how to make semi-monthly deposit against taxes due
• IRS requires use of Electronic Funds Transfer (EFTPS) – how do I do that?
• How does the IRS feel about combination products and kitting sets? Will we get more guidance?
• What is an appropriate paper trail that will satisfy the IRS in case they audit me?
• Six considerations for mitigating the tax; for example, R&D credits, property tax abatements, federal grants

Who Will Benefit
This webinar is a must for professionals in the device industry, including:

• Medical device manufacturing and executives 
• U.S. importers of medical devices
• Regulatory affairs and compliance professionals
• Strategic planning and business development staff
• Financial accountants and support staff
• Engineering executives

Meet the Instructor
Tax Partner with Beene Garter, Dan Lynn, CPA, MBA, offers more than 20 years of experience working with medical device manufacturers and importers. He has specialized knowledge in the areas of manufacturing and distribution, as well as continuing care retirement communities. His areas of expertise include mergers and acquisitions, business transition, accounting methods and tax transactional consulting. He also has experience in tax due diligence, FAS 109, consolidated corporations, and the taxation of partnerships, S corporations, and trusts. Lynn earned his Bachelor of Arts Degree and his Master of Business Administration in Accounting from Michigan State University. He currently serves as an adjunct professor of taxation at Grand Valley State University, and also serves on their MST and MSA Advisory Panels. His professional memberships include the American Institute of Certified Public Accountants (AICPA), the Michigan Association of Certified Public Accountants (MACPA), and the Association for Corporate Growth (ACG).

• Webinar Details
  
• Date: Tuesday, March 12, 2013 
• Location: Your laptop, office, or conference room
• Time: 1:30 p.m. – 3:00 p.m. EST; 12:30 p.m. – 2:00 p.m. CST; 11:30 a.m. – 1:00 p.m. MST; 10:30 a.m. – 12:00 p.m. PST; 6:30 p.m. – 8:00 p.m. GMT
• Price: Webinar PLUS Audio CD and Transcript: $547 – Best Value!

You will have access to one log-in and dial-in for the live 90-minute webinar for unlimited participants. You also receive all presentation materials and the opportunity to ask questions by phone and email, plus an audio CD and transcript for the entire session.

Webinar Only: $347
You get one log-in and dial-in for the live 90-minute webinar for unlimited participants, presentation materials and the opportunity to ask questions by phone and email.

Invite your entire team for maximum benefit!

Register today for one dial-in and log-in – and bring as many participants as you wish.

Interested in registering multiple sites?
Call 888.838.5578 in the U.S. or +1.703.538.7600 globally to learn about our special multisite discount.

Three Easy Ways to Register
Please mention priority code 13228 when registering.

1. Enroll online.
2. Call 703.538.7600 or toll free 888.838.5578 (inside the U.S.) 
3. Mail your check to: FDAnews, 300 N. Washington St., Suite 200, Falls Church, VA 22046-3431.

Unable to Attend?
Choose between the Audio CD and transcript or listening in on the Encore presentation:

• Audio CD and Transcript Only: $327 (plus shipping and handling) - You will receive an audio CD and written transcript of the entire 90-minute webinar, including the Q&A period, and all presentation materials. Delivery is approximately four weeks after the session. 
• 24/7 ENCORETM Audio Presentation PLUS Audio CD/Transcript: $527 - You will have access to one dial-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for unlimited participants. You can dial in any time of day or night for three weeks, from March 18 – April 5, 2013. You will also receive all presentation materials, plus an audio CD and transcript for the entire session. 
• 24/7 ENCORETM Audio Presentation: $327 - You will have access to one dial-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for unlimited participants. You can dial in any time of day or night for three weeks, from March 18 – April 5, 2013. You will also receive all presentation materials.