MDMA Annual Meeting
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MDMA Submits Comments on FDA Reprint Guidance
April 21, 2008 -Today MDMA submitted comments to the FDA related to the distribution of medical or scientific journal articles and reference publications that involve off-label use of medical devices. Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of this type of information was not viewed by the FDA as evidence of an intent to promote the product for an unapproved or off-label use. However, Section 401 expired on Sept. 30, 2006.
MDMA's comments 
CMS Releases Proposed Inpatient Rule
April 14, 2008 - The Centers for Medicare and Medicaid Services (CMS) released the proposed hospital Inpatient Prospective Payment System (“IPPS”) rule. As expected, CMS addressed several areas of concern to the medical device industry including, but not limited to, charge compression, new technology add-on payments, physician owned medical device companies and gainsharing.
CMS also address several other areas of general concern. CMS estimates that payments to acute hospitals will increase by $4 billion in the next fiscal year. In addition, CMS projects that hospitals that report all of the required quality measures will receive a full market basket update of 3% while non-reporting hospitals will receive an update of only 1%. CMS will also complete the three-year phase-in of cost-based weights and the two-year phase-in of Medicare Severity Diagnosis Related Groups (MS-DRGs).
MDMA will continue to follow developments with the proposed IPPS rule and will submit comments to CMS accordingly.
More information on the rule
MDMA Joins the National Healthcare Career Network
April 9, 2008 - MDMA announced its participation in the National Healthcare Career Network (NHCN). The NHCN is an initiative that brings healthcare associations together to provide job placement and advancement opportunities; career development tools, training, scholarships and resources to alleviate employee shortages facing the healthcare marketplace. The NHCN promotes healthcare associations’ specialized job boards and online career centers as valuable resources for finding and developing industry-specific talent.
“We are excited to join our colleague organizations in taking the lead on this collaborative effort,” said Mark Leahey, MDMA Executive Director. “We want to be a valuable resource to the employers we serve, so they will continue
to seek out the association community as their first choice for recruiting.”
Visit the MDMA Career Center today to post your job or resume.
Proposed Patent Rules Exceed PTO’s Authority
April 7, 2008 - The US District Court for the Eastern District of Virginia granted GlaxoSmithKline a summary judgment in its challenge to the final rule on continuation applications issued by the PTO last August. In sum, the judge ruled that the proposed rules exceed PTO's statutory rule-making authority which does not extended to "substantive" rule-making. MDMA is pleased with the court's decision. It will ensure that innovators will be able to protect their IP in the medical technology field.
MDMA’s Comment Letter 
MDMA Testifies on SBIR Reauthorization
March 13, 2008 - MDMA testified before the House of Representatives Committee on Small Business regarding reauthorization of the Small Business Innovation Research (SBIR) program. MDMA’s testimony focused on the importance the program has had in the development of medical technologies. MDMA also recommended that the reauthorization legislation include changes to current law and regulations including an increase in Phase I and Phase II grant levels and refining the small business ownership definition to include businesses with a majority ownership by venture capital investors.
To read MDMA’s testimony, please click here 
Supreme Court Limits Lawsuits Against Medical Device Manufacturers
February 22, 2008 - In a landmark decision, the Supreme Court upheld initial lower court rulings that medical device manufacturers cannot be held liable in state tort cases if the device has been approved by the Food and Drug Administration. The case, Reigel v. Medtronic, is significant because it reaffirms that existing Federal device approval laws preempt individual state regulations. Specifically, the ruling applies to devices approved by the FDA under a premarket approval (PMA) application.
MDMA submitted an amicus curiae brief before the Court argued the case.
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10th Annual Coverage, Reimbursement and Health Policy Conference
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