Today HHS announced the ACO program continues to expand with the addition of 106 new ACOs. The agency is forecasting a savings in Medicare outlays for health care of $940 million over the next 4-years as a result of the formation of ACOs across the Country. […]
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.
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.
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.
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 [...]
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.
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 [...]
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.
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 [...]
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 [...]