Jennifer Whitney07.20.06
MDMA Wrap-Up
Government Officials Convene With Device Manufacturers to Examine Today’s Top Issues Facing the Industry
Jennifer Whitney
Editor
CDRH Director Dan Schultz chats with MDMA Executive Director Mark Leahey and MDMA Board Member Paul Touhey, president and COO of Fujirebio Diagnostics. |
At the meeting, held June 13-15 in Washington, DC, officials from the FDA and CMS also took center stage with updates on each agency’s activities.
Andrew von Eschenbach, acting commissioner of the FDA, reported that the FDA is currently working toward implementing a more modern IT infrastructure to enable more consistency and transparency in the regulatory process and bring new technology to market quicker.
This IT platform will offer the FDA benefits such as electronic adverse event reporting, document-tracking and e-consults between FDA personnel at various locations. Also, “turbo 510(k),” ie, electronic submission, will help standardize the 510(k) process and reduce chances of error.
Along these lines, the FDA’s CDRH Director, Daniel Schultz, noted that while tracking systems are already in place to help modernize the FDA’s post-market monitoring system, more development is still needed. “We need to be able to provide patients and physicians useful information in real time,” he said.
Emerging technology is one area of particular interest to the FDA moving forward, especially since areas such as computer-related technology have been plagued with recalls due to software issues. According to James Ravitz, partner for Arent Fox, the FDA is paying close attention to RFID use in the pharmaceutical industry. “This technology would extend device turnkey capabilities,” he explained, noting that the device industry will see growing use of RFID to aid in post-market monitoring of medical products.
The FDA also is working on developing other new approaches to safety. One example is the development of a “virtual family,” which simulates adult and pediatric models to help predict—before devices are tested in humans—what technology will or won’t work.
With all the recent initiatives of the FDA (eg, the Critical Pathway Initiative, Medical Device Innovation Initiative), Schultz noted that the FDA—whose budget allocates more than 80% of its resources to personnel—has been adding more staff, especially those with engineering backgrounds, to better evaluate new technology. In addition, outside consultants are still being leveraged and will continue to be used.
Attention is also being given to the FDA’s advisory panels. Noting that the medical device industry has criticized the agency about some panel members’ experience (or lack of it), Schultz offered, “We have a responsibility to make sure we have the right people at those meetings. It’s not an easy process, but it’s something we can’t abandon.”
In terms of quality, the agency is looking to reduce the number of inspections held for companies having multiple locations. “We need to find a way to bridge the gap so that one inspection serves multiple jurisdictions,” Schultz said. No specific action plan was provided.
Gainsharing Debates Heat Up
The state of the Medicare system was also up for discussion at MDMA’s meeting. Gainsharing, a practice of hospitals giving incentives to doctors who choose from a limited number of products on the market, was of particular interest to attendees.
Noting that $120 billion is currently spent annually by Medicare on hospital payments, and $24 billion for physician payments for in-patient care, Mark Wynn, PhD, director of the CMS’s Division of Payment Policy Demonstrations, said the CMS is looking at gainsharing as a possible way to align hospital and physician interests while maintaining efficient operations.
Mark McClellan, CMS administrator, told attendees that the intention of current gainsharing pilot programs is to “support quality care and promote efficiency of care.”
Not many in attendance appeared to agree.
Andrew Imparata, President of the American Association of People with Disabilities (AAPD), told MDMA members that studies show that as many as half of people with disabilities (including, in one study, those who have Medicare as their sole form of health insurance) go without the medical equipment they need. He worried aloud that gainsharing could adversely affect patient-physician relationships, which are especially important to people with these medical conditions.
“It’s hard to find the right doctor,” he said. “We’re concerned that if a patient believes his or her doctor is looking at the least expensive options, it’s going to harm the relationship.”
Physicians should be worried about the potential impact to their bottom line as well, he noted. Since many doctors treating patients with disabilities often find the patient’s condition difficult to treat with conventional methods, the AAPD doesn’t want to see doctors get penalized for having “difficult to treat patients who may cost a little more than average.”
Another concern rests with the measurement of gainsharing’s overall value. Mark Leahey, executive director of the MDMA, urged lawmakers to exercise caution before proceeding with gainsharing on full steam.
“It’s important to differentiate between a theoretical model and better ways to effect change,” Leahey said. “We hear so much about gainsharing improving quality, but the $64,000 question is, how do you measure quality?”
McClellan acknowledged that “we face some real threats and challenges in health policy,” but added, “We [at CMS] want to do our part to promote effective innovation.”