A bipartisan group of lawmakers introduced legislation last month to change Medicare to cover ultrasound screening for abdominal aortic aneurysm (AAA), often called a "silent killer." At a Capitol Hill press conference, Sens. Christopher Dodd (D-Connecticut) and Jim Bunning (R-Kentucky) and Rep. Gene Green (D-Texas) joined members of the National Aneurysm Alliance (Washington) and aortic aneurysm survivors to announce the SAAAVE (Screening Abdominal Aortic Aneurysm Efficiently) Act.

According to the National Aneurysm Alliance, about two out of three AAA rupture victims die before they can reach the hospital. The organization estimates that 2.7 million Americans may have the condition. The normal diameter of the aorta is about 2.5 centimeters. Aneurysms of 5.5 centimeters or greater pose the greatest threat. "This is an under-diagnosed, under-identified killer of Americans," said Robert Zwolak, MD, vascular surgeon and chair of the alliance. "But if identified, this condition is completely treatable and curable." He said that while most AAAs are never diagnosed, almost all could be detected using inexpensive and painless ultrasound screening. Because of the slow progression of the disease, Zwolak said that just one Medicare-covered screening at or after the age of 65 would identify the condition in almost all high-risk individuals.

The American Heart Association (AHA; Dallas, Texas) estimates that some 15,000 people die each year from ruptured AAAs. In addition, because death is so sudden, AAA often is misdiagnosed as a heart attack or stroke, and AHA believes that thousands of AAA-related deaths go unreported annually.

If enacted, the SAAAVE Act would provide coverage under Medicare Part B for a one-time ultrasound screening to identify AAA. A screening by a qualified technologist would be covered for any Medicare beneficiary who has a family history of AAA, shows risk factors for cardiovascular disease or shows signs of atherosclerosis. The legislation also would provide for a national education campaign to promote awareness among healthcare professionals and the public about early detection and treatment. The alliance says that lack of reimbursement often is cited as the reason that ultrasound screening is not used or recommended for patients.

"If white men between the ages of 50 and 60 are most at risk, I'm going to go get screened tomorrow," Dodd quipped. "Seriously, we are going to do something about this. We will develop strong bipartisan support and get this through Congress. This is not an expensive procedure, and it saves lives." Dodd said that everyone's first question would be how much it costs. He said that projections are that the program could cost $200 million to $400 million over the next 10 years. "But what are the costs of not doing it?" he asked. "We'll do everything we can to convince our colleagues." Dodd said that while there was limited time to get it through during the current session, he would push hard to get it through once Congress was back in session. "I promise you we will do what we can to make this the law of the land," he said.

Giving his remarks a personal note, Bunning said he has had two friends affected by AAA. "This is an essential bill," he said. "The cost is nominal compared to the number of lives that can be saved." Bunning echoed Dodd, saying that though time was short before the upcoming recess, this legislation would be a priority for him upon his return.

"There are no warning signs," AAA survivor Normand Shaw said during the press conference. The 62-year-old Shaw knew there was a family history of AAA, but was not screened until his doctor raised concerns. A 13.3 cm enlargement of the aorta was discovered, which eventually burst in the middle of follow-up tests. "Although the costs related to my surgery, hospitalization and recovery are staggering, they pale in comparison to the impact that screenings will have on the thousands of people each year who may be saved," he said.

The National Aneurysm Alliance is a group of medical professional organizations, patient advocates, individuals and medical technology manufacturers.

Better evidence seen as reimbursement key

Say the word "location" three times fast and you've got the basic mantra for how to pick prime real estate. The parallel mantra for the Center for Medicare & Medicaid Services (CMS; Baltimore, Maryland), as well as the FDA, would seem to be "evidence, evidence, evidence."

That was the off-voiced message by the government regulators participating in a panel on advancing new technologies held during last month's annual conference of the Medical Device Manufacturers Association (MDMA; Washington) at the Phoenix Park Hotel in Washington.

The evidence mantra was repeated several times by new CMS administrator and former commissioner of the FDA, Mark McClellan, MD, who most often put it in a "yes, but" type of formula as in "yes, we are trying to deliver more of the newest medical technologies to patients and consumers, but we need better evidence to do so."

As for accomplishing this, McClellan stressed the importance of cooperation between government and industry in the med-tech field, and added: "We have the greatest opportunities ever with the new sciences, yet we haven't had substantial impact on [bringing these to] patient care." And he referred to the too-frequent "overuse, underuse or misuse" of medical technology resulting from this gap.

A continuing effort for improving the utilization of new medical technologies, he said, was a closer collaboration between CMS and the newest mandates laid out by the Medical Device User Fee and Modernization Act, which he cited as an example of the FDA's commitment to speeding regulatory approvals.

Overall, he described the current era of scientific research and regulatory issues as creating "a public policy crossroads," one increasingly complicated by the rising cost of healthcare that makes new technologies more difficult to pay for, and a "lack of good, practical evidence" about these technologies. "The path we choose today," he said, "is either more innovation or wasted opportunities," with the latter course resulting in patients and the public being "uncertain and angry."

McClellan said, "We need new steps to get med-tech developed sooner, guided by better evidence. Too often therapies are widely used but poorly assessed as cost-effective alternatives." As an example, he cited complex diagnostics, all expensive, and "promoted with limited knowledge of the benefits."

McClellan avoided putting the onus for the lack of cost and risk/benefit knowledge on the industry, but suggested it was a problem with systemic sources and causes. "The system hasn't evolved to measure these [technology] benefits," he said. And he laid out a variety of ways in which CMS will be attempting to improve the quality and efficiency of data-gathering for new technologies. These included the development of better data-gathering tools, acquisition of more information concerning the quality of care provided by new technologies, the expansion of CMS's Open Door Forums, greater dependence on economists "trained in these evaluations" and, from the industry, "asking for additional and more specific advice" about new technologies.

McClellan said that CMS's new Council on Technology and Innovation would help to focus on improved evidence-gathering following FDA product approvals especially with broader use of information technology and electronic data collection. And still another program will be a wide-ranging effort to analyze "coordination of care mechanisms later this year to improve the cost of care" in treating chronic conditions and including measures of patient/provider satisfaction.

He said that the results of these studies would be developed over the next year or two "at much lower cost." And he promised more such studies as "a more systematic integrated way to promote rapid diffusion of new treatments."

In the Q&A period that followed, one attendee asked, as part of a two-part question, how companies with breakthrough technologies could succeed against medical practices and "powerful blocks that exist, representing the status quo." McClellan failed, or perhaps forgot, to answer the question, but it was taken up later by Sean Tunis, MD, chief medical officer and director of the Office of Clinical Standards and Quality at CMS, who referred to these "entrenched interests" and how to deal with them.

"We're interested in trying to facilitate decision-making to benefit the Medicare population [by creating] a level playing field," Tunis said. This could be done, he said, by "what evidence you can bring to the table." While acknowledging fewer resources by small companies for doing this, he also downplayed the extent to which the larger firms actually invested in developing the required evidence. Smaller firms "don't have to do a 1,000-patient study," Tunis said, but might achieve coding with a study using 50 people and a carefully selected control group.

And he emphasized the value of truly innovative ideas, citing a company that has approached CMS with the idea of a "wearable dialysis belt" to provide continuous dialysis. While he acknowledged that this presented a clear case of a technology that could threaten "entire dialysis interests," he said: "Come on in and convince us that [you have] an interesting product and we'll try to move it along."

Tunis also used his panel presentation to attempt to dispel some misinformation floating about. He said that while CMS and the FDA are currently working on ways to collaborate and share expertise to make better decisions, the two agencies are not going to overlap in their key areas of decision-making. In particular, Tunis said that there might be some "parallel review" of products by the two agencies, but that the FDA will not have a say in CMS coverage decisions and "will not, in my lifetime, do cost-effective analysis."

Task force warns against funding cuts

A task force led by the Alliance for Aging Research (Washington) held a meeting on Capitol Hill last month to release its report highlighting developments in medical research and new technology and the need for increased funding for the National Institutes of Health (NIH; Bethesda, Maryland). The report, titled 2004 Task Force on Aging Research Funding: Meeting the Needs of the 21st Century, says that Congress must increase NIH funding by 8% to 10% for fiscal 2005 in order to "meet the goals of medical and scientific discovery for generations to come." The report is being circulated to members of Congress and other policymakers in an effort to boost disease prevention research.

Daniel Perry, executive director of the Alliance for Aging Research, said "boom-and-bust cycles" would put millions of Americans at risk. "It is damaging to medical research infrastructure and the investments we've made," he said. "We can't do this and expect that we will have the critical mass of young men and women coming into the scientific and medical fields and the talent staying there to do this very important work." Perry said the report not only delivers a message to Congress it details by disease and condition the number of Americans affected, the research that has produced advances, and outlines the need for urgent, accelerated progress in scientific and medical research.

The report urges Congress to uphold a national commitment for medical research by increasing funding for fiscal 2004, make age-related research a greater priority and increase awareness of potential opportunities for healthier aging. It addresses age-specific conditions and diseases, in addition to their cost in terms of research and healthcare. The report also outlines women's health and social and behavioral experiences as an individual ages.

Over the next 25 years, according to Perry, the number of Americans older than 65 will double. He said 75 million baby boomers will move onto Medicare and half of that number will be older than 75. "Imagine the cost of today's healthcare multiplied by four, because there will be four times the number of people at risk for diseases such as Type 2 diabetes, arthritis and neurodegenerative diseases like Alzheimer's and Parkinson's," he said. "The only way we are going to manage that inevitability is we, in the laboratory, find a way to reduce the impact of these diseases through the innovation and the intellectual capacity of American science."

Perry said during the past five years that the NIH budget has doubled thanks to strong bipartisan support, but that funding for 2004 has "hit the skids." He said the outlook is similar for the next few years, with negative funding a possibility by 2006. According to the Centers for Medicare & Medicaid Services, healthcare spending is increasing by nearly 10% a year and was $1.6 trillion in 2002.

The report says that the debate over healthcare financing too often focuses on the cost of healthcare, rather than the cost of disease. Even modest reductions in diseases and their effects can yield savings, it says. For example, if research efforts could find a way to delay the onset of Alzheimer's disease by five years, there would be an annual savings of roughly $50 billion. "We do not want to be caught unprepared," said Rep. Lois Capps (D- California). "If I ever get discouraged about what we do in Washington, I look at the important work being done at the National Institutes of Health. It is critical that we do not stop the critical flow of funding, and Congress needs to pay attention to the findings [of the report]." Capps, who has a degree in nursing, said that it is her goal is to provide a 10% increase in NIH funding. "Over the objection of many members [of Congress], myself included, as well as members of the public health community, we have only provided a 3% increase for fiscal 2004," she said. "We also are facing a request from the administration for a 2.6% increase."

The congresswoman said that when you compare this to inflation and research costs, in addition to the dramatic increases in bioterrorism research at the NIH, a 3% increase would actually cut funding in many areas. To continue the rate of research growth, Capps advocated a 10% increase in funding, which is in line with the report's findings.

"It will not be easy, but my challenge to my colleagues is that we either make public health a priority or we don't," she said. "This cycle of boom and bust that we have been all too guilty of in the House and the Senate jeopardizes the investments we have made in the past. The roller-coaster effect needs to stop." Capps said that the key is to give funding a face and to put the effects of continued research in terms that the public and lawmakers can understand.

Monica Liebert, PhD, director of the American Urological Association's (Linthicum, Maryland) Office of Research and a speaker during the event, likened the current funding situation to running a marathon in which after every mile run, the runner stops for a year. "That's what happens with intermittent funding," she said. "That starting and stopping is not cost-effective, and it is difficult to maintain the momentum of good research. We are losing the opportunity to cash in on investments that already have been made."

Sixty-six organizations make up the task force.

Parents' AF increases risk for offspring

Having a parent with atrial fibrillation (AF) appears to strongly increase an offspring's risk of also developing this disorder, according to a new study of participants in the National Heart, Lung, and Blood Institute's (NHLBI; Bethesda, Maryland) Framingham Heart Study. The risk doubled for offspring with at least one parent with AF, compared to offspring whose parents did not have the condition. The study of 2,243 adults, published in the June 16 issue of The Journal of the American Medical Association, is the first to find a genetic connection for AF in a community sample.

Barbara Alving, MD, acting director of the NHLBI, one of the components of the National Institutes of Health, said, "This important research finding will need to be confirmed, but it opens up a new avenue of research on atrial fibrillation. Now scientists can start looking at genetic factors that might contribute to AF searching for the genes involved in this increasingly common disorder." The study's findings give support to the theory that AF has genetic underpinnings. Most cases of AF occur in older people. The disorder affects about one in every 10, aged 80 and over. In the new study, the risk of AF tripled when both parents and the offspring were under age 75. The risk also tripled when the analysis was limited to offspring who had no clinically apparent heart disease.

"Disorders with a genetic component often occur at a younger age or in the absence of major diseases like heart disease that trigger the condition," said lead investigator Caroline Fox, MD, of the Framingham Heart Study.

The Framingham Offspring study of AF involved 1,165 women and 1,078 men whose parents were members of the original Framingham Heart Study. The offspring were at least 30 and free of AF at the first exam. Offspring and original study participants had routine clinic exams, including physical examinations, interviews, lab tests and electrocardiograms. AF in both offspring and original "parental" participants was confirmed by an electrocardiogram. Parental cases occurred from 1949-2002, and offspring AF cases occurred from 1983-2002. When the Framingham researchers analyzed the data, they found that 30% of participants had at least one parent with AF. Seventy offspring (23 women) developed AF during the study at a mean age of 62. When stated in terms of 1,000 persons per year, the results indicate that the number of offspring developing AF would be 4.5 if a parent had AF and 3 if parents did not have AF.

Fox cautioned that the Framingham findings should not alarm people who have a parent with AF. "AF, with or without a family history, is a common condition in the elderly," she said. "Our findings indicate to the scientific community that we need more research on the genetic mechanisms of AF and how they interact with environmental influences." Fox added that Framingham scientists hope to conduct further research into the genetic basis of AF.

The prevalence of atrial fibrillation is rising, with scientists predicting that about 5.6 million Americans will have the disorder by 2050. Known causes of AF include abnormalities in the heart's structure and long-term, uncontrolled high blood pressure, and it is considered the source of various complications, including stroke and congestive heart failure. Treatment via drugs, surgery or devices is designed to slow the heart rate and/or restore normal rhythm, and to prevent stroke.

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