Medical Device Daily Washington Editor

WASHINGTON – The Advanced Medical Technology Association (AdvaMed; Washington) has thrown its hat into the ring of groups weighing in on the subject of health information technology (HIT), on Friday releasing a white paper titled “Health Information Technology: Improving Patient Safety and Quality of Care.”

The document discuses the role of medical devices in IT – beyond just electronic health records (EHRs) – and includes multiple case studies and recommendations for industry. And it calls for policy that speeds the adoption of HIT.

According to AdvaMed, the paper provides evidence supporting “how smart, digitally enabled medical technologies are making dramatic improvements in patient safety, quality of care, and significantly reducing costs.”

However, there still are barriers in place that keep doctors, healthcare facilities and device manufacturers from realizing the benefits of an electronic system. The largest, AdvaMed said, is cost.

“The start-up capital and ongoing commitment of resources to maintaining HIT-related equipment is one of the biggest, if not the biggest barrier we’re seeing,” Seth Radus, AdvaMed’s associate vice president for federal government relations, told Medical Device Daily.“There need to be more financial incentives that give healthcare providers the ability to make the up-front investment in advanced HIT systems, he said. “I think there are various ways in which you could provide incentives for the purchase and dissemination of HIT.”

Better reimbursement from insurance companies and the Centers for Medicare & Medicaid Services (CMS; Baltimore) would be one way, Radus said, thus rewarding physicians that are using HIT systems and achieving better quality of patient care as a result. This currently is part of CMS’ pay-for-performance pilot program now under way for physician practices.

Better capital financing options would be another method of breaking down barriers to IT adoption by doctors and hospitals. This would be of particular interest to smaller physician practices. “That’s a real problem with the small physician practice,” he said. “Not just the start-up capital, but the funding to maintain and update the technology.”

Some incentives also could come in the form of tax breaks, according to Jan Foote, an associate vice president at AdvaMed who has focused on the group’s HIT initiatives.

“There has been some talk in Congress and in the academic community about tax incentives for physicians,” Radus added. “But it also could be new money in terms of federal health expenditures.”

Foote and Radus pointed out that not all incentives need be financial – at least not in terms of start-up and day-to-day funding.

Doctors and device companies also would be able to implement improved HIT systems if certain regulatory roadblocks were removed.

For example, exceptions to provisions of the federal healthcare program anti-kickback statute and the physician self-referral law – the so-called Stark law.

The Stark statute applies only to physicians who refer Medicare and Medicaid patients for specific services to entities with which they, or an immediate family member, have a financial relationship.

The lists of designated health services and financial relationships covered by the statute are broad, though there are some exceptions.

Foote said the office of David Brailer, MD, national health information technology coordinator, has been actively working on reviewing the Stark statutes as they relate to HIT.

“As far as the Stark law and antitrust law in the area of HIT, doctors need be allowed to receive help from certain entities – hospitals or vendors – without it being considered against the law,” Foote said. “This will help them get started.”

“We’re not necessarily advocating for one [plan] in particular over another,” Radus said. “We would be happy with any financial rewards for purchase or adoption of health IT, but we also realize that pay-for performance is something that Congress and the administration is considering in various forms. And we would feel it would be an appropriate method of helping to disseminate health IT in various ways.”

Some of the devices that AdvaMed identified as being integral parts of a modern HIT system would include, for instance, infusion pumps that help prevent overdoses and reduce medical errors, image guided or computer-assisted surgery, and devices with computerized components, such as implantable cardioverter defibrillators that enable data transmission to physicians via the Internet.

These and similar devices would be tied together by a system of electronic health records for every patient.

Remote monitoring both in and out of the hospital setting is an expanding field of the device sector. Monitoring technology and telemedicine – especially in rural and remote areas – help improved monitoring of chronic disease patients in their homes. The electronic transmission of radiological images represents another area that is being affected by current HIT limitations, according to the AdvaMed white paper.

“From the standpoint of our industry, remote monitoring and some of the devices that our companies are producing actually cut healthcare costs, and they’re not getting reimbursed for any of it right now,” Foote said.

According to a recent study conducted by the Center for IT Leadership (Wellesley, Massachusetts), ambulatory EHRs could potentially save payers $78 billion to $112 billion annually.

Both Foote and Radus said that a partnership between the public and private sectors is the best way to achieve a workable, interoperative system of standards, rather than a list of mandates established by government.

“I think the way in which it is being done right now – in a public-private partnership – is the best way to create those standards and maintain them,” Radus said. “Industry is obviously working with this on a daily basis, and they are best equipped to handle this, in conjunction with some government involvement to spur them along to make some final decisions.”

Foote said that various organizations outside government already have been working with standards for many years. One of the organizations Foote identified was the Certification Commission for Health Information Technology (Chicago), which is involved with creating a credible and sustainable mechanism for the certification of healthcare information technology products, “much like JCAHO [Joint Commission on Accreditation of Healthcare Organizations],” he said.

“So why reinvent the wheel, if you already have agencies out there that are very qualified,” she added.