Acting FDA commissioner Lester Crawford said last month that the FDA is open to considering an overhaul of – or perhaps even a “different system” than – the current user fee program put in place by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

Addressing the annual meeting of the Medical Device Manufacturers Association (MDMA; Washington) at Washington’s Madison Hotel in mid-May, Crawford praised the program as the key to recent improvements in product approvals and clearances by the Center for Devices and Radiological Health. But he said he also recognized the industry’s concern with escalating fees. “I think going to a different system should be put on the table, and I would be open to that,” he said.

MDUFMA, now in its third fiscal year, has drawn sharp criticism from the device industry because of rapidly increasing fees as a result of shortfalls in the number of applications received by the agency over the last few years.

MDMA has been the most vocal in its opposition to the MDUFMA compensating adjustor, which allows the shortfalls of one year to roll into the next and forgives Congress its shortfall obligation.

Mark Leahey, MDMA’s executive director, said that this places an unfair burden on industry, especially the smaller, entrepreneurial companies developing innovative technologies and which the organization tends to represent.

According to Leahey, Congress has delivered less than 50% of the funds promised, while industry has met 90% of its obligation. “We simply cannot sustain these dramatic fee increases,” Leahey said. “We need to do more to ensure that these fees are reasonable and that there really is improved performance from FDA in exchange for these fees.”

A fix of the compensating adjustor is mandated by Oct. 1. If a consensus can’t be reached among the FDA, Congress and industry, the program will sunset. “We do support paying FDA a reasonable fee for enhanced performance, but we’re not willing to perpetuate a broken program,” Leahey said.

Crawford told the meeting attendees that there are ongoing conversations with Congress and industry, saying that FDA “is working hard to find a solution that will address the industry’s concern.” He said there are meetings on Capitol Hill on a regular basis, but he declined discussing any specifics. “But it is in all parties’ interest to find a solution,” he said. “It would be unfortunate to have MDUFMA end in the near future.”

In response to one MDMA member’s charge that higher fees are keeping many companies from filing certain submissions for fear of the cost, Crawford said that he has seen no evidence that there is a “chilling effect” as a result of higher fees. “The last thing we would want is to impede cutting-edge companies in any shape, form or fashion,” he said. “But there are things we have to work out.”

Crawford said the user fee program has been – in part – the cause of a culture change at FDA. He described the agency 10 to15 years ago as “aloof” and not actively engaged in the development of new technology. “I like the idea of it [the user fee program] because it helps brings us face to face with the industry, and it allows us to collaborate and develop goals for the future,” he said. “We basically didn’t know what was going on in the pipeline for any of the products we regulated.”

He said the program has provided the revenue to build “much-needed infrastructure” to enhance agency performance, enable it to hire more experts and produce reduced product review times. In 2002, 77% of 510(k) approvals occurred within 90 days, according Crawford. By 2004, that number had increased to 85%. He also noted that decision time for pre-market approval applications has decreased from 260 in 2002 to 218 days last year.

Opponents have argued that there needs to be a better way to evaluate FDA performance goals, saying that agency productivity had improved even before the implementation of MDUFMA.

‘Stirring things up’ at CMS

As for the reimbursement side of the gauntlet med-tech firms have to run to have a shot at commercial success. Barry Straube, MD, the recently named acting chief medical officer of the Centers for Medicare & Medicaid Services (CMS; Baltimore), says he is bringing his “West Coast, open-minded approach” to his work at the agency.

Participating in a panel discussion at the MDMA meeting, Straube told the audience that he planned to “stir things up a little bit” at the agency, regardless of whether his position is a short- or long-term appointment. In his new role, he also serves as acting director of the Office of Clinical Standards and Quality. He most recently served as chief medical officer of the CMS region in the western U.S., based in San Francisco.

Straube replaces Sean Tunis, MD, who was placed on administrative leave in the latter part of April following allegations that he falsified continuing medical education documentation. Tunis will remain on leave until the charges are resolved, CMS said at the time.

“I think that given my background in critical care nephrology and transplantation, I have a perspective in the world that you all live in, one that perhaps many of the folks at CMS perhaps don’t have,” Straube told the device audience. “I have instructed the folks in my office to be more open than ever and to work as collaborators with industry.”

He said that when he first started with CMS four years ago, he was “na ve” about the complexities of the agency, especially in the area of coverage decisions. With more than 76 million beneficiaries, and more than $500 billion spent on all agency programs last year, the agency’s actions often can seem enigmatic, Straube acknowledged to meeting attendees.

One of the more notable changes in the agency’s philosophy is a culture shift from one of only a payer to that of a public health agency, driven by CMS administrator Mark McClellan, MD, Straube said. “We can use the power and authority of the agency to try and effect change in the U.S. healthcare system across all systems and payers.”

The agency’s move toward a more “transparent and predicable” process in releasing its national coverage decisions, is another area of transformation he identified.

Another is health information technology promotion and adoption. “We cannot do quality improvement in the country at the level that we need to unless we have implementation of health information technology systems throughout the healthcare industry,” Straube said.

Other ongoing demonstration projects include CMS pay-for-performance initiatives and coverage with evidence development (CED), which has generated some controversy for the agency. One of the most recent CED decisions from CMS – the move to expand coverage of implantable cardioverter defibrillators – directly impacted the device sector.

CMS says this approach allows it to provide beneficiaries with “faster and broader access to an item or service,” while at the same time enabling access to new technologies while gathering data on the beneficiary population at the same time. The data can then be used to support a wide range of initiative inside and outside of CMS.

Straube said direct input from the device sector would be required, going forward, to help the agency “get up to speed” with rapidly changing technology. “One of our biggest faults has been the predictability of our decisions. We’ve done a lot of work on transparency, now we have to work on predictability,” he said. “Come to us. Ask some questions. Make presentations to tell us what is coming up the pipeline so we know what we may need to consider going forward.”

Coverage with evidence development will allow CMS to make earlier coverage decisions, Straube said, “while allowing safety and overall benefits and better definition of target populations, especially for device services.”

Dual-chamber pacemakers more beneficial, but ...

The fact that a medical technology has been in use for a long time does not mean that all the important clinical questions about its use have been completely resolved. The clinical use of cardiac pacemakers is a case in point. When ECRI (Plymouth Meeting, Pennsylvania), an independent health services research agency, recently surveyed its U.S. hospital subscribers regarding their use of single- and dual-chamber pacemakers, it said that the results were unexpected.

Based on the results of that report, the organization compiled an evidence report indicating that while dual-chamber devices were clinically superior to their single-chamber counterparts, more research needs to be done to in order to make a definitive argument for their use in all cases.

ECRI – formerly known as the Emergency Care Research Institute – is a non-profit health services research agency. Its mission is to improve the safety, quality and cost-effectiveness of healthcare. The organization’s focus is healthcare technology, healthcare risk and quality management, and healthcare environmental management. It provides information services and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, voluntary sector organizations, associations and accrediting agencies worldwide.

This latest survey showed that the pacemaker type that hospitals implanted (single or dual) varied for reasons that seemed unrelated to patient indications or clinical characteristics. ECRI spokesperson Lindsay Ehlers Cox said the agency surveyed a sampling of its healthcare organization members about a year and half ago, and discovered some interesting results that spurred the initiation of the report. “We found that some of the things that we had thought about their pacemaker usage were completely off.”

For example, she said, ECRI expected to find that teaching hospitals, which typically treat more complicated cases, implanted more dual-chamber pacemakers than community hospitals did in their patients. However, survey results showed that a higher number of implants in the teaching hospitals were of single-chamber models.

These unexpected findings, coupled with ongoing questions from hospitals about which pacemakers to use, led the agency to conduct a systematic review of published evidence on pacemakers to ascertain which type of pacemaker to use in order to achieve the best patient outcomes.

ECRI published its systematic review in April as a Windows on Medical Technology evidence report titled “Dual-Chamber vs. Single-Chamber Pacemakers for Sinus Node Dysfunction and Atrioventricular Block.”

Each year, about a half-million Americans receive pacemaker implants to regulate abnormally slow or fast heartbeat. These electronic devices are mostly used to treat abnormally slow heartbeat rhythms, or bradycardias, which, if untreated, cause symptoms such as fatigue, weakness, dizziness, fainting and sometimes death. Bradycardias most often are caused by sinus node dysfunction and atrioventricular block.

Drawing from an evidence base of 32 trials that enrolled more than 5,500 patients with these conditions, ECRI pooled data to perform various meta-analyses. They concluded that dual-chamber pacemakers, which pace both the ventricles (lower chambers) and the atria (upper chambers) of the heart, are more clinically beneficial and cost-effective compared to single-chamber models, which pace only the ventricles.

The evidence base for this report comprised five parallel-arm, randomized controlled trials with 5,372 patients and 27 randomized crossover trials with 526 patients. These two trial designs evaluated different outcomes (the parallel-arm trials evaluated mortality and serious morbidities such as stroke and heart-failure hospitalizations; the crossover trials focused primarily on exercise tolerance and pacemaker syndrome). Except for functional status and pacemaker syndrome, ECRI said it analyzed parallel-arm trials and crossover trials as two separate bodies of evidence.

While the cost of the dual-chamber device is higher, much of the analysis pointed to, albeit not in an overwhelmingly statistically significant way, the benefits of such a system over its single-chamber cousin. Analysts found that dual-chamber pacing reduces symptoms of pacemaker syndrome, which causes dizziness and fatigue when the pacemaker attempts to pump against a closed valve.

The report also found that dual-chamber pacing leads to a lower risk of stroke than single-chamber ventricular pacing, with a meta-analysis finding that dual-chamber pacing led to a 25% reduction in the rate of stroke relative to single-chamber ventricular pacing.

Additionally, the report found that dual-chamber pacing led to lower risks of heart failure hospitalization and atrial fibrillation (AF). The organization’s meta-analysis found that dual-chamber pacing led to a 20% reduction in the rate of heart failure hospitalization relative to single-chamber ventricular pacing and that dual-chamber pacing led to a 24% reduction in the rate of AF relative to its single-chamber counterpart.

Another interesting conclusion was that dual-chamber pacing led to a lower combined rate of serious adverse events (mortality, stroke, heart-failure hospitalization) than single-chamber pacing, with the analysis showing a 14% reduction in the combined rate of serious adverse events relative to single-chamber ventricular pacing.

Analysts found that dual-chamber pacing is not necessarily superior to single-chamber pacing relative to improvement in cardiovascular functional status. Also, some evidence showed that dual-chamber pacemakers had more mechanical problems, although these were generally minor.

ECRI said it recommends that while dual-chamber pacing appears to lead to more clinically significant benefits, practitioners should carefully weigh their options prior to implant. While she said, “in many of the criteria that we had set for this evaluation, the dual chamber prevailed,” Ehlers Cox noted that until there is more conclusive evidence the decision to use either a single- or dual-chamber pacemaker “has to be made on a case- by-case basis.”

Inaugural program highlights CT angiography

Leading-edge imaging for cardiology was the featured technology at an inaugural conference in Milwaukee, sponsored by the Wisconsin Heart Hospital. “CT [computed tomography] Angiography for Cardiologists” is the name of the two-day conference, and this imaging application “is taking off like a house afire” in cardiology, said Sam Wann, MD, chairman of the Wisconsin Heart Hospital’s department of cardiovascular medicine, and also currently active in both the American College of Cardiology (ACC) and the American Society of Nuclear Cardiology (both Bethesda, Maryland), which co-sponsored the first-ever event.

“CT Angiography for Cardiologists” also was the first conference sponsored by the hospital – open less than a year and a half – a smaller facility focused entirely on cardiovascular diagnosis and treatment. The bottom line, Wann told CDU, is that CT angiography (CTA) in the hands of cardiologists, not just radiologists, ultimately will provide cath lab-type imaging and information about the cardiovascular system but without cath lab-type invasiveness. CTA uses X-rays to visualize blood flow in arterial vessels throughout the body. Critical to this technique is the combination of X-ray images with computerized analysis of these images.

“The promise is to do coronary angiography, hopefully, with intravenous injection and a single breathhold – of 10 seconds or less – using CT and providing diagnostic-quality images,” Wann said. “We’re not there yet,” he added as a qualifier. “But we’re close, and people are very, very excited about it.” CTA has made more advancements in Europe, primarily Germany and the Netherlands, Wann noted, while adding that the U.S. “will catch up,” with educational conferences such as the current effort.

The critical core of vendors at the conference included GE Healthcare (Waukesha, Wisconsin), Philips Medical Systems (Andover, Massachusetts), Siemens Medical Solutions (Malvern, Pennsylvania) and Toshiba America Medical Systems (Tustin, California), manufacturers of the CT machines, plus various other workstation and imaging agent providers.

With independent rather than vendor-type sponsorship, the event was an “ecumenical, not a proprietary kind of presentation,” Wann said. It included a number of breakout sessions featuring “experts, with a variety of different equipment, to show [attendees] how they use them in clinical practice – the advantages, the pitfalls,” he said. The conference also featured a patient CT procedure via live television feed.

A faculty of 15 cardiologists, described by the organizers as “all leaders in their field at major academic and private practice institutions” made presentations. Among the CT scan pioneers offering their expertise were Michael Poon, MD, chief of cardiology at Cabrini Medical Center (New York). Poon is billed as a leader in the effort to get the Centers for Medicare & Medicaid Services and private insurance companies to pay for the procedures. “I don’t think there’s any question that [CMS] should reimburse this,” Poon said. “[CT angiography] has really unique clinical utilities.”

He added: “Traditionally, we do a lot of invasive diagnostic coronary angiograms that are normal. You might ask why we would do an invasive test that has risks for the patient– one in 1,000 for a heart attack or a stroke. Until recently, we haven’t had a non-invasive option. The invasive test costs the payer about $10,000 and in one recent case, where the patient had to be kept in the hospital for two days before having an angiogram that was normal; she got a bill for $25,000. In that same scenario,” he explained, “the patient could be scanned with the CT and if it comes out normal, you send the patient home the same day. The cost would be about $800.”

Another conference presenter was Joao AC Lima, MD, associate professor of medicine and director of cardiovascular imaging at Johns Hopkins Hospital (Baltimore). “This conference is very important because it comes at a time when cardiologists are quickly realizing the power of multi-detector CT angiography to look at coronary arteries and study them,” he said. “We realize that this is a powerful tool that could be used effectively for patients with heart disease. For example, it could help us gauge which patients should be taking the statin medications and whether this therapy is working to prevent cholesterol buildup in the arteries,” Lima said. “If the technology fulfills its promise, I consider CT Angiography of the same magnitude as the introduction of invasive angiography and ultrasound technologies in the 1970s, which transformed the practice of cardiovascular medicine.”

Open only since January 2004, the Wisconsin Heart Hospital is focused, Wann said, on leading the way in encouraging “all hospitals in our system [Covenant Healthcare] and in others to use CT angiography.” He noted that the hospital currently uses a 16-slice CT machine but will soon be upgrading to the more powerful 64-slice machine.

“We’re very happy to have the level of cardiac care rise in our community and we’d like to help do that,” he said. “As a result of this conference, I hope that cardiologists will take this information home and start doing it on their own CT machines. It is a state-of-the-art machine, but it’s not one that other hospitals couldn’t buy.”

Ohio funds disease centers

A consortium of Ohio organizations made up of the Cleveland Clinic, Case Western Reserve University (both Cleveland), the University of Cincinnati, plus several medical device firms, has received $22.8 million from that state to establish an Atrial Fibrillation (AF) Innovation Center at the Cleveland Clinic.

A second consortium received $6 million to fund age-related macular degeneration research based at the Clinic’s Cole Eye Institute, and a third Clinic-led group was awarded $4 million to establish a Clinical Tissue Engineering Center – a total of $32.8 million

The new Atrial Fibrillation Innovation Center will be one of the state’s Wright Centers of Innovation, which consist of large-scale, research and technology development platforms designed to accelerate the pace of Ohio commercialization. Supported by large grants, the Wright Centers have been created under Ohio’s Third Frontier Project, a 10-year, $1.1 billion initiative to expand high-tech capabilities and innovation within the state.

Merle Madrid, a spokesperson for the Ohio Department of Development, told CDU that the Third Frontier was a program initiated by current Ohio governor Bob Taft, in 2002. The purpose: “to unite Ohio’s First Frontier, which is agriculture and the Second Frontier in manufacturing, with the Third Frontier, which is the knowledge-based economy that’s going to drive business in the 21st century.”

The grants, according to Madrid, are currently funded by the general revenue fund of Ohio and, since their inception in 2002, distributing thus far roughly $330 million.

“The centers and research funded today involve the collaboration of some of the top clinicians, laboratory researchers, technology companies and venture capitalists in the nation,” said Delos Cosgrove, MD, president and CEO of the Cleveland Clinic. “The joint efforts of these individuals and institutions will result in important new tools for diagnosing and treating disease while creating new medical products and bringing new wealth to Ohio.”

Importantly, the grants are being used as a way to help promote better paying jobs in Ohio by funding high-tech industry. Several companies involved in the partnership, but not all, are located in the state.

Eric Topol, MD, chairman of the department of cardiovascular medicine and provost and chief academic officer at the clinic, said that five of the companies involved in the Wright Center grants are Ohio-based, “meaning these projects could promote hundreds of new Ohio jobs over the next five years.”

AF is a common condition that causes rapid, uncontrolled heart rhythms. About 2.2 million Americans have the condition, including nearly 100,000 Ohioans, the clinic noted in a statement. The condition also accounts for more than one in five strokes.

Led by the clinic, the Atrial Fibrillation Center team will implement a five-part program to ensure that new AF research and therapies are developed, and then commercialized, for the benefit of patients.

Companies involved in the Atrial Fibrillation Innovation Center include Atricure (West Chester, Ohio), Philips Medical Systems (Cleveland), Sinus Rhythm Technology (Plymouth, Minnesota) and Symphony Medical (Eden Prairie, Minnesota), Boston Scientific (Natick, Massachusetts), Cardionet (San Diego), Cyberonics (Houston) and St. Jude Medical’s (St. Paul, Minnesota) Cardiac Rhythm Management division.

Officials in Ohio are determined to keep the Third Frontier project going on a long-term basis, noted Madrid. He said that an initiative on the ballot in November will seek to extend the grants. “It’s a $2 billion bond package, $500 million of which is Third Frontier money that allows us to bond that out long-term to continue to provide for things like this and to even expand it.”

AHA, MicroLife in education program

Microlife USA (Tampa, Florida) and the American Heart Association (AHA; Dallas) reported that they have formed a sponsorship agreement on a free, personalized online program that will educate consumers on the importance of heart health and the control of high blood pressure.

Microlife will be a national sponsor of the AHA’s High Blood Pressure Patient and Professional Heart Profilers, an online educational tool “for patients, loved ones and caregivers and a clinical reference tool for professionals,” the company said. Microlife will notate AHA sponsorship on its blood pressure monitoring marketing materials.

The company joins the AHA and NexCura (Seattle), developer of the Heart Profilers tools, with a goal of generating awareness among healthcare professionals and the public on high blood pressure and its associated risks. The program goals include the encouragement of dialogue between patients physicians and increasing participation in the Heart Profilers program. “The Heart Profilers program allows people to be proactive with their heart health and take charge of it in a meaningful way,” said James Mault, MD, a heart surgeon and Microlife chief medical officer.

Microlife will co-market the AHA’s Heart Profilers programs and use its relationships with pharmacy retailers to inform customers about this source of health information. The company also will help educate customers about the importance of monitoring their blood pressure at home with a validated blood pressure monitor to ensure accuracy.