Medical Device Daily Washington Editor
WASHINGTON – “The best way to predict the future is to invent it.”
The quote belongs to Alan Kay, one of the pioneers of personal computing in the 1970s and 1980s. Kay’s work led to the development of today’s modern computer workstations, including the use of overlapping-window interfaces, desktop publishing, and even laser printing.
In an address during this week’s annual meeting of the Medical Device Manufacturers Association (MDMA; Washington), Mark McClellan, administrator of the Centers for Medicare & Medicaid Services (CMS, Baltimore), borrowed Kay’s words to describe some of the changes currently under way at his agency.
This is the third year in a row McClellan, formerly FDA commissioner, has spoken at the MDMA meeting. This year’s talk highlighted the agency’s more aggressive policy of technological adoption leading to better patient outcomes.
“So much of what we are trying to achieve with our country’s health policy depends on medical technology to bring better, safer medical technologies,” he told the device audience at the Madison Hotel here on Wednesday. “We need to work together to find better ways for doctors and patients to use these devices to achieve greater benefit, while avoiding excess spending, and making the process as efficient as possible.”
McClellan said that when he thinks of the device sector, he often thinks of the information technology revolution. He said Kay’s quote is fitting for medical devices. “There are lots of small medical device and technology companies working hard to make healthcare better,” he said.
Government’s role should foster innovation, not hinder it, McClellan said, which means agencies such as CMS need to take a more active role in understanding and following the technology, then making it available to its beneficiaries.
“Really smart people with reasonable funding can do just about anything that doesn’t violate too many of Newton’s laws,” he said, quoting Kay again. But he said that most device companies would probably add, “Don’t run afoul of the FDA approval process and Medicare coverage decisions.”
McClellan said there’s a balancing act in government’s involvement in healthcare. “Government’s substantial involvement in financing means product markets are much larger than if individuals had to pay for the care and technology on their own, without government subsidies,” he said. “But the concerning side of course is what happens if requirements get in the way of adding real value because they are not based on the best and latest science.”
As part of the Medicare Modernization Act (MMA), the agency’s goal, in addition to the very public debate about prescription drugs, is to make its actions “more transparent, predictable and evidence-based,” McClellan said.
The word “transparent” is bandied about a lot in Washington, but he said CMS’s activities since the beginning of the year and going forward will demonstrate how the agency is transitioning from payer to healthcare provider.
“This is the best opportunity in a generation to fundamentally improve our system for improving the delivery of healthcare in this country,” he said. “We are making policy more focused on quality, more responsive to patient preferences, market forces, and more alert to cost. And to award those companies that meet those core goals.”
The key to program savings is to support innovative new treatments that help patients live longer and better lives, McClellan said. Because the CMS program is so large – more than $500 billion spent last year – its actions have an impact on the overall healthcare system in the United States.
McClellan said new coverage decisions have included new preventative care and screenings, and the push toward electronic prescribing and electronic medical records. “There has not been enough progress in electronic records or coordinated care,” he said. “We are not preventing complications as much as we should, supporting the business case for improved quality.”
Most of what Medicare spends today deals with complications of chronic diseases after they occur – dialysis, controlling diabetes, complications with lung disease – all of which can be avoided with more proactive care, McClellan said.
CMS’s latest push toward pay-for-performance initiatives and coverage with evidence decisions are all examples of the how the agency is using and embracing greater technological innovation, the administrator said. “Hospitals get paid more when patients get better care, when there are fewer complications, readmissions, lower costs overall,” McClellan explained. “Until now, there wasn’t a business case for it because Medicare previously paid you less for fewer visits.”
Devices have played a big role in much of CMS’s most recent coverage decisions and the push for its coverage with evidence development initiative, including implantable cardioverter defibrillators and ultrasound treatment for healing bone fractures (Medical Device Daily, May 18, 2005).
“The best way to maximize quality of outcomes is to use new technology as effectively as possible and to maximize investment in medical devices and other innovation,” he said. “Effective public-private partnerships are key to success in this area.”
Nancy Briefs, new MDMA chair and president and CEO of Percardia (Merrimack, New Hampshire), said the MMA is good news for devices. “The MMA will have a profound impact on the medical device industry – payment of new technologies, increased coverage in clinical trials and enhancements to the national coverage policy,” she said.