Q Review Volume 3, Issue 2 - April 2007
MDUFMA II Reauthorization
Since early 2006, MDMA has been in discussions with the Food and Drug Administration (FDA) and other industry stakeholders to reauthorize the Medical Device User Fee and Modernization Act (MDUFMA) program which will help ensure that patients have timely access to safe and effective products. Specifically, MDMA sought to improve and simplify the MDUFMA performance goals, increase collaboration between FDA and the industry, and create a fee structure that is more stable and provides greater fee relief for small companies. Fortunately, the agreement reached by FDA and industry and approved by the Senate HELP Committee on April 18th achieves these objectives.
To learn more about the agreement please click here
MDMA Remains Committed to Increased FDA Funding
In February, the President released his $2.9 trillion budget proposal for Fiscal Year (FY) 2008. In the budget, the President requested for the FDA a budget total of $2.1 billion, which is a net program level increase of $263 million over the Fiscal Year (FY) 2007 Continuing Resolution. Within the overall FDA budget, the President requested a total of $240 million for the Center for Devices and Radiological Health (CDRH), which is a total of $20 million over the FY 2007 Continuing Resolution. However, this budget does not
MDMA has joined two Washington coalitions, the FDA Alliance and the Coalition for a Stronger FDA. These coalitions are lobbying Congress to increase FDA’s budget authority. MDMA has been active in meeting with Congressional staff on the importance of this issue and we believe that funding FDA at an appropriate level would restore FDA’s operational capabilities so that it can carry out its public health and safety initiatives. To learn more about these organizations, please visit
http://www.strengthenfda.org/
http://www.fdacoalition.org/
More FDA News
In March, FDA issued a draft guidance document proposing to exclude individuals who have a financial interest in the companies coming before the panel from serving on the advisory committee. FDA did make an exception for individuals who have a financial interest below $50,000. Those individuals may serve as a non-voting member on the committee.
To learn more, please click here.
Also in March, FDA released the long awaited draft guidance for industry and FDA staff on Modifications to Devices Subject to Premarket Approval (PMA) – the PMA Supplement Decision Making Process. The draft guidance document reflects FDA’s review of what they believe are the relevant issues related to providing regulatory submissions for modifications to medical devices (including in vitro diagnostics regulated by CDRH or CBER) and what FDA believes would be the least burdensome approach. Comments are due in 90 days.
To read the guidance, please click here 
Payment Issues
In February, the Centers for Medicare and Medicaid Services (CMS) held a New Technology Informational Workshop in conjunction with their annual New Technology Townhall meeting. CMS presented on the factors involved in deciding whether a technology will receive a new technology add-on payment (i.e. newness criteria, costliness, and whether the technology provides a substantial clinical improvement over existing technologies). In addition, they also provided background on requesting an ICD-9 diagnosis or procedure code and then being placed into the corresponding Diagnosis Related Group (DRG). Finally, they discussed the process for obtaining Pass-Through and New Technology Payments in the Outpatient Prospective Payment System (OPPS).
To review the slides presented at the meeting, please click here
In March, MDMA presented at the biannual Advisory Panel on Ambulatory Payment Classifications (APC) meeting at CMS. Specifically, MDMA made the following recommendations: 1) we asked the Advisory Panel to recommend that CMS require the use of C-codes for all device-dependent APCs in the 2008 OPPS proposed rule; 2) we requested that the Panel recommend that CMS institute a payment floor in 2008 or keep all rates at the 2007 payment level; and 3) we requested that the panel urge CMS to maintain a two year minimum threshold of New Technology and Pass Through APCs so that data has the time mature before being placed into a clinical APC. At the meeting, CMS presented preliminary data stating that of the 42 device dependent APCs only 6 of them are likely to see a payment decrease in 2008 and of the 6 only 2 will decrease by more than 10 percent.
The Council on Technology and Innovation ~
MDMA staff met with senior officials on CMS’s Council for Technology and Innovation (CTI) to discuss issues of coding and coverage. MDMA, along with three other industry associations, relayed our requests to CMS regarding making the Pass-Through Application and New Technology APC process more predictable and transparent and to keep services in new tech APCs for a minimum of two years. In addition, we highlighted the importance of getting the OPPS system as accurate as possible given that the new ASC payment system is going to be based on it. We further articulated the need to extend the use of new technology ambulatory payment classifications and device pass-through payments to the ASC setting. Finally, we stressed the need to preserve the local coverage process and to help inform, especially small medical device manufacturers of any changes that may occur as a result of the MAC transition process. To learn more about CTI, please visit http://www.cms.hhs.gov/CouncilonTechInnov/
GPO Reform Efforts Continue
In January, MDMA attended the Health Industry Group Purchasing Industry Initiative’s (HGPII) Annual Forum in Charlotte, NC. The meeting brought together the largest GPOs to discuss the latest developments in their industry. MDMA reiterated its support of the concept of GPOs, but reinforced its opposition to a supplier funded GPO model. As Michael Porter states in his book, Redefining Health Care, “there is no valid reason for buying groups to accept financing or any payments from suppliers: if a buying group adds value, the customer (hospitals) should voluntarily pay for it”.
The controversy over the Malcolm Baldrige Award continued throughout this quarter. The San Diego Tribune highlighted the controversy over Premier being named one of the recipients. In the article it states, “Premier and other leading health care group-purchasing organizations, or GPOs, have been the subject of a five-year probe by the Senate Subcommittee on Antitrust, Competition Policy and Consumer Rights.” The article also highlights Premier’s close ties with the Baldrige Foundation.
To read the article, please click here
Commercialization workshop
MDMA in cooperation with Vector Resources, LC held a product commercialization workshop in Washington, DC on March 22, 2007. Participants interacted with leading healthcare executives who shared their real-world experience in successfully executing a wide range of product commercialization approaches. Attendees learned more than six proven strategies for the commercialization of medical devices, as well as discussed the ones best suited for various types of products and companies.
Annual Meeting
Please join MDMA at the upcoming 2007 MDMA Annual Meeting, Celebrating 15 Years of Achievement 1992 - 2007. This premier industry conference brings executives from innovative medical technology companies together with healthcare's most influential and respected decision makers. The program will feature speakers from industry, Congress, the Food & Drug Administration, and the Centers for Medicare & Medicaid Services. Attendees include high-level medical technology executives, attorneys, consultants, and others seeking to learn more about trends in the industry.