Medical Device Excise Tax Update
We believe this letter between our general counsel and the IRS to be good news for people who sell used equipment, and good news for most sales of refurbished equipment.
Fiscal Cliff Legislation Includes Cuts In Advanced Medical Imaging
When the House of Representatives voted to avert the "Fiscal Cliff" the legislation included $800 million in Medicare cuts for advanced imaging. These cuts are on top of those already proposed in 2012. Read more about it here.
Good News for Third-Party Service Providers
We have learned from the Regulatory and Systems Branch of the FDA that companies that only provide third-party service are not required to register.
Medical Device Excise Tax
Preliminary Note: In 2010 the Medical Device Excise Tax law was enacted. The IRS issued two weeks ago a forty page preamble and eighteen pages of regulations with respect to its scope and implementation. 26 C.F.R. Part 48. The IRS also issued a ten page guidance document. This compilation is based on the IRS preamble, regulations and guidance document issued [...]
FDA Clarification Requested
We requested FDA clarification on the new regulations concerning Medical Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices. Read our letter here.
IAMERS Medical Device Excise Tax Letter
Here is a copy of the letter from Rob Kerwin, General Councel for IAMERS, to Kara Getz, Esq., Tax Counsel to the Hon. Richard E. Neal, U.S. House of Representatives, regarding the January 2013 Medical Device Excise Tax. It is our priority to get clarification from the Department of Treasury on whether or not the excise tax applies to [...]
Request to Delay Medical Device Tax
To keep you updated with our efforts in Washington, below is a link to a letter that was sent to the US Senate Majority Leader requesting a delay in the medical device tax. Read it here.
Medical Device Excise Tax
The regulations regarding the Medical Device Excise Tax were published in the Federal Register today. You can read them here. As the document is rather long, and includes supplemental documents, we will time to summarize how this affects IAMERS members. We have already requested more clarification on used equipment. We will post additional information as we [...]
Apples to Apples Regulatory Approval Times No Less In Europe
A study recently appeared in the NEJM comparing the average approval times for innovative, high risk medical devices in the U.S. and in Europe. It appears for new devices the approval times are similar overall. I think the key is that these are innovative (new technology) rather than more of the same. The authors of [...]
7.26.12 – GAO report on the ACA implementation of “Meaningful Use” show few hospitals and professionals qualify
http://www.gao.gov/assets/600/593078.pdf In case you forgot what it means here's a working definition for Meaningful Use. From a publication of the Robert Woods Johnson Foundation: Glossary of Health Care Quality Terms, Meaningful use— Meaningful use is a qualification to receive federal funding for health information technology. For instance, if a health information technology (HIT) system is used in a meaningful [...]