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MDMA submitted three comment letters to the Centers for Medicare and Medicaid Services (CMS) during the fourth quarter. Specifically, MDMA commented on the Outpatient Prospective Payment System proposed rule, the Ambulatory Surgical Center proposed rule and CMS’ Coverage with Evidence Development Guidance document. In the Outpatient Prospective Payment System (OPPS) proposed rule, MDMA stressed the importance of the mandatory use of device c-codes as well as the need to use correctly coded claims. MDMA also articulated the need to use credible confidential external data to validate costs determined by CMS’ claims data. Finally, MDMA advocated for greater predictability and transparency in the New Technology and Pass-Through Application process. To read the comment letter please click here. Regarding the proposed rule on the Ambulatory Surgical Center (ASC) payment system and calendar year 2008 payment rates, MDMA emphasized the importance of appropriately setting the conversion factor so that procedures and the products used in those procedures would be adequately reimbursed. To read the entire letter, please click here. This fall, CMS released a Final Guidance document on Coverage with Evidence Development (CED) and MDMA submitted comments to the CMS on it. Promoted by CMS as an alternative vehicle for procedures to receive coverage which otherwise would be denied coverage, CED is still an avenue which the device industry has not fully embraced. MDMA strongly articulated to CMS that it must collect, aggregate and disclose research data collected through CED in a manner that minimizes the burden on patients, providers and manufacturers. To read MDMA’s comment letter, please click here. |
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Before the end of the 109th Congress, the Senate confirmed Dr. Andrew von Eschenbach to become the Commissioner of the Food and Drug Administration (FDA) by a vote of 80 to 11. Dr. von Eschenbach, the former director of the National Cancer Institute, has been the acting Commissioner since September 2005. MDMA looks forward to working with Dr. von Eschenbach as the permanent head of the FDA to ensure that innovative, entrepreneurial companies are represented as policies develop. |
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- FDA Receives Permanent Commissioner - Other FDA News - Commenting to CMS - Capitol Hill Update - Controversy over the Nation’s Prestigious Baldrige Award - Membership Has Its Benefits - Successful 9th Annual Reimbursement Conference |
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In this issue of the MDMA Quarterly Review: |
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MEDICAL DEVICE MANUFACTURERS ASSOCIATION Innovation Today for Better Health Care TomorrowTM |
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MEDICAL DEVICE MANUFACTURERS ASSOCIATION |
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The November elections brought significant changes to Capitol Hill with Democrats taking control of both the House of Representatives and the Senate. In the Senate, the Democrats elected Senator Harry Reid (D-NV) to be the Majority Leader and Senator Mitch McConnell (R-KY) to be the Minority Leader. In the House, Rep. Nancy Pelosi (D-CA) became the Speaker of the House, and Representative Steny Hoyer (D-MD) was elected the Majority Leader and Representative John Boehner (R-OH) was elected the Minority Leader. Before breaking for the holidays, the 109th Congress passed one last piece of important legislation, H.R. 6111, the Tax Relief and Health Care Act of 2006. The bill included a one year physician payment fix for physicians who are reimbursed for treating Medicare patients by not enforcing the anticipated five percent cut and freezing physician payment at the 2006 rate. In addition, the legislation provided a seamless extension of the R&D tax credit through December 31, 2007. To pay for this $6.5 billion physician pay fix, Congress reduced the Medicare health plan stabilization fund from $10 billion to $3.5 billion. |
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In October, the FDA held a public meeting on emergency research conducted without informed consent and MDMA submitted comments to the FDA regarding its draft guidance entitled “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research.” MDMA is supportive of ensuring that FDA eliminates the confusion caused by the existing regulations and that emergency medicine clinical research is advanced so that unconscious patients presented with cardiac arrest, stroke (who are comatose), traumatic brain injury and other life threatening medical conditions receive the best treatment. To read MDMA’s letter, please click here. FDA continues to move forward with the concept of Unique Identifiers for medical devices, and the agency held a public meeting in October on the topic. MDMA submitted comments in which we stressed the importance of a voluntary, universal system. Click here to read MDMA’s comments. This fall, MDMA joined two organizations, the FDA Alliance and the Coalition for a Stronger FDA, both non-profit groups dedicated to addressing the FDA congressional funding shortfall. Both of these organizations are seeking to tackle the problems that occur when FDA has inadequate resources, and they are working with congressional members to educate them on the need to provide FDA with the resources it needs so it can maintain its gold standard reputation. |
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The Medical Device Manufacturers Association (MDMA) is a national trade association based in Washington, D.C. that represents independent manufacturers of medical devices, diagnostic products and health care information systems. We are offering exciting new member benefits and have several upcoming meetings, conferences, and webinars. To learn more about these events, please contact Erin Jones Director of Membership |
