We all know that most of our medical expenses occur at the end of life. This study reported by AuntMinnie showed that stage 4 Medicare cancer patients were being sent for advanced imaging studies more frequently than those with earlier stages of disease. The conclusion drawn by the investigators was that guidelines have to be developed for the appropriate use of advanced imaging in stage 4 cancer patients. I suspect the Government and other payers will be looking closely at the results of this investigation.
7.26.12 – GAO report on the ACA implementation of “Meaningful Use” show few hospitals and professionals qualify
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 way to provide better patient care, a health system can qualify to receive federal subsidies to help to pay for the technology.
Health Imaging an online medical news magazine on July 25th reported on a study done by GE and MIT. They examined the reasons for the slowdown in medical imaging that began in 2006. It’s an interesting read and relevant to all sellers and users of medical imaging devices.
Diana Upton, IAMERS President and Casper Uldriks, FDA expert and former Associate Director at the FDA, team up in a recent DOTmed News interview
In the interview they discuss the FDA UDI (unique device identifier) regulation and the 2.3% excise tax on capital equipment imposed under the ACA and the potential for each to affect the medical equipment markets. If you missed the interview on DOTmed News here’s a second chance to follow this interesting discussion with the experts.
The IAMERS FDA Committee has also been reviewing the proposed regulations concerning the Unique Device Identification System. The proposed rule was published for comment in the July 10, 2012 Federal Register. Comments on the proposed rule are due by September 10 as they pertain to information collection issues under the Paperwork Reduction Act of 1995 and by November 7, 2012 for the substance of the proposed rule. In many ways the proposed rule follows the general tenets of the Global Harmonization Task force by requiring that each medical device be labeled and that information on the label (e.g., type of device, lot, batch number) be captured in plain text and in a form that automatically identifies and captures information (bar code). Little is said as to when the UDI is to be changed and how the UDI is to be captured on large equipment purchases. While the expected implementation date for Class II devices is expected to be three years after the final rule, the IAMERS FDA committee is working with the FDA on addressing issues of particular concern to our industry. The full proposed rule and comment are readily accessible on the FDA website. (Caution: its lengthy). IAMERS welcomes comments concerning the proposed rule and the proposed requirement of post market surveillance (whereby information concerning the equipment is kept for purposes of product recall).
IAMERS met with tax counsel from a senior member on the U.S. House Ways and Means Committee to discuss some need for clarification of the medical device excise tax (currently set for assessment in January 2013. Under the proposed regulations a tax will be imposed on the sale of any “taxable medical device” by its “manufacturer” or “importer” at a rate of 2.3% of the price for which it is sold. IAMERS has asked for a clarification that used and refurbished devices (sold domestically) are not subject to the tax.
Following the Supreme Court decision on the constitutionality of certain aspect of the ACA last month everyone with an opinion has chimed in either for or against. Today there is an interesting post reporting on the impact to the cost of implementing the ACA after the Supreme Court Decision. Here is how the Congressional Budget Office (CBO) views the costs changing as States opt in or out of the Medicaid portion of the ACA and other events occur. Continue Reading…
For some it means Bring Your Own Device. For others who experienced network crashes from viruses contributed by people hooking their personal device into the company network it means Bring Your Own Disease or Destruction. In this modern age the mobile device is a wonderful addition to our ability to communicate. But if you are concerned about how these devices might crash the network you may find a recently posted Webinar of interest. Continue Reading…
Here’s another study questioning the usefulness of screening mammography. This one is from Sweden and reported in DOTmed news on July 18. Here’s the link: http://www.dotmed.com/news/story/19165?utm_campaign=2012-07-19&utm_source=DOTmed+News&utm_medium=email Continue Reading…
Recently IAMERS was rated in the top ten sites for international due diligence for medical equipment. Actually we were #3. Take a look, the word is getting around.