A task force led by the Alliance for Aging Research (Washington) held a meeting on Capitol Hill last month to release its report highlighting recent 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 year 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 policy makers 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," Perry 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 but also 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 experienced 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 [that] 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 that during the past five years 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 (Baltimore, Maryland), 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 year 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."

Sixty-six organizations make up the task force.

Proposed legislation targets 'silent killer'

A bipartisan group of lawmakers introduced legislation last month to change Medicare to cover screening 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. Rep. Jim Greenwood (R-Pennsylvania) also is a sponsor of the bill, but was unable to attend the event.

The condition occurs slowly and without any symptoms. When the aorta bursts, it comes without much warning and causes massive internal bleeding usually resulting in death, though a small percentage of patients receive treatment in time. According to the National Aneurysm Alliance, about two out of three rupture victims die before they can reach the hospital. The organization estimates that 2.7 million American may have the condition. The normal diameter of the aorta is about 2.5 cm. Aneurysms of 5.5 cm 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 National Aneurysm Alliance. "But if identified, this condition is completely treatable and curable." Zwolak 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. Because death is so sudden, it 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 reimbursement often is cited as the reason that ultrasound screening is not used or recommended for patients. Dodd said, "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." 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." Bunning added, "This is an essential bill. The cost is nominal compared to the number of lives that can be saved."

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

AdvaMed focusing on specific sectors

In response to calls from its member organizations, the Advanced Medical Technology Association (AdvaMed; Washington) has reported plans to form two new sector programs in the areas of digital health information and advanced wound management, with these efforts addressing patient access barriers and other policy issues in these arenas. According to Blair Childs, an executive vice president of AdvaMed, the new programs will broaden the organization's ability to serve the needs of the businesses in these sectors by responding to ongoing changes in med-tech. "Our role is to provide a mechanism, to provide a forum through which the industry can organize itself," Childs told BBI. "This organization has the most expert people on reimbursement, regulatory and international issues for the medical technology industry."

Childs said that the challenge is that the medical technology industry is so heterogeneous. "There are very distinct areas within the membership ophthalmic, orthopedic, digital health, wound management, cardiovascular so it is beneficial for them to coalesce and organize to form an approach to policy." There is a concern among AdvaMed's member companies, according to Childs, about reimbursement issues and that CMS is lagging behind in terms of getting accurate codes and that the agency's wound management policies are antiquated. "[As] with many different technology areas, CMS just has a very difficult time coping with the pace of innovation," he said. "So this is an effort by member companies to really organize around this and see that they are able to help ensure that there is a more organized process to interact with CMS on the reimbursement issue."

Childs said that while it may not be a particularly "sexy" topic, there is "remarkable innovation going on in the wound care area." According to AdvaMed, about 5 million Americans suffer from chronic wounds each year, costing more than $1.7 billion in 2003, and that many of these painful and costly wounds could be avoided with appropriate treatment and management. The medical technologies for treating chronic wounds in AdvaMed's wound management focus include advanced specialty dressing, bioengineered skin substitutes, wound closure devices, hyperbaric oxygen equipment and pressure relief beds.

As to the digital health information technology arena, Childs said this consists of much more than patient records, but that almost every part of medical technology now involves some sort of digital interchange. "The way digital health or health information technology tends to be defined these days is medical records," he said. "But in fact, every company is using the Internet, digital communications, wireless communication systems, as well as all kinds of software, to capture data, to analyze data and to streamline the decision-making process for healthcare professionals and patients. We are moving more and more toward a digital-based healthcare system, beyond healthcare records, and the industry really needs to be involved."

The four areas that will make up AdvaMed's focus in digital health are implantable technologies and external devices, clinical information systems, laboratory diagnostic information systems and supply chain management. As an example, Childs cited changes in orthopedic surgery and imaging technology. "Used to be you would have surgery, and the doctor would implant the orthopedic device," he said. "Now there's computer-assisted surgery." Digital information technology in this case changes how the physician operates, using digital equipment to ensure devices are implanted precisely and securely. In this way, Childs emphasized, the surgery is more minimally invasive, which means faster recovery for patients.

"The point is that all of the technologies being developed today involve use of software that collects information, makes it available to physicians and increases the productivity of healthcare workers and the healthcare system," he said. "Disease management is another area that can do a lot to promote the use of digital health technology such as telemedicine, which is part of the Medicare bill that was just passed."

Childs said that AdvaMed currently still is defining precisely where it will focus its work in the sector in terms of policy, but that there "clearly are significant FDA regulatory issues that are of concern to [member] companies, as well as reimbursement issues." President George Bush recently highlighted the potential impact of health information technology on patient care by calling for most Americans to have electronic health records within the next 10 years.

JCAHO cites donated organs shortage

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO; Oakbrook Terrace, Illinois), issued what it deemed a "call to action" last month regarding the gap between patients needing organ transplantations and organ donors, and cited the 6,000 people who die each year waiting for transplants. In total, about 85,000 people are waiting for organ transplants in the U.S. today, the organization said. Unfortunately, those numbers grow daily, and JCAHO in a white paper suggested that the current epidemics of morbid obesity, hypertension and diabetes along with the prevalence of infectious liver disease would make that number grow even more until it becomes a "critical public health issue" in coming years. In other words, it said, it will escalate to the point that it becomes everyone's problem in some fashion, no longer excluding those who think they will never be touched by the need for organ donation.

"Organ donations obviously save lives," said Dennis O'Leary, MD, president of JCAHO, in a telephone panel discussion. "Each day, an average of 68 people receive organ transplants, all miracles that we've grown accustomed to. For these individuals, this is a special second chance; however, another 16 people on the waiting list die each day because not enough organs are available." He added, "Until supply catches up with demand an unlikely prospect in the current environment America faces a growing healthcare problem."

The paper and the panel also addressed the disparities that exist between whites and those in racial and ethnic minorities as well as the fact that many people who have mental or physical disabilities never even make it to the waiting lists because of those disabilities, despite the fact that they are medically suitable for transplant. O'Leary pointed out that the white paper, "Health Care at the Crossroads: Strategies for Narrowing the Organ Donation Gap and Protecting Patients," offers solutions. "The white paper . . . describes a series of three broad strategies, sets forth 33 recommendations and identifies accountabilities for each recommendation," he told listeners. "What becomes clear in this analysis is that all the key players must come together in a concerted fashion. These include hospitals, physicians, other clinicians, organ donation coordinating groups, regulators, educators, public policy makers, community leaders, researchers and advocacy groups."

One strategy he cited would be to make organ donation a priority "by focusing efforts on the hospitals having the greatest potential to identify donors and implement national best practices for organ donation, including education of hospital staff about organ donation." That effort would also require examination of the financial issues involved that contribute to or detract from decisions resulting in organ donation, which could be addressed by "encouraging Medicare reimbursement for costs relating to maintenance of potential donors prior to declaration of death." Another effort that must be undertaken, he said, is to ensure the same access to waiting lists for transplantation is equitable between all racial and ethnic minorities as it is with whites and to ensure that those with disabilities also are not excluded.

O'Leary offered other suggestions, including the fact that the "growing dependence on living donors means that particular efforts must be made to assure that those making the gift of life are properly informed of their rights and receive the same excellent care provided to donor recipients." That has become a flashpoint due to deaths that have occurred among those who chose to be living donors, the white paper said.

Thirdly, he suggested that all organizations "seek new ways to meet the demand for organ donation, such as developing protocols that would provide for and encourage donation after cardiac death." One of the major problems faced in organ donations is when an individual who has consented to be an organ donor does not actually become one when hospitals consult family members after death, even though their consent is not required by law. "What we've seen far too many times is that a person while living and competent makes a decision to donate organs upon his or her death, and unfortunately, after death, family views on organ donation are solicited. And they may actually trump the wishes of the donor before his or her death," said panelist Ronald Davis, MD, director of the Center for Health Promotion and Disease Prevention for the Henry Ford Health System (Detroit, Michigan).

Elizabeth Duke, PhD, administrator, Health Resources and Services Administration in the Department of Health and Human Services (HHS; Washington), cited a collaborative model for increasing organ donations launched last year by HHS Secretary Tommy Thompson, whom she called a "passionate advocate of organ donation." She said, "Part of what we're doing in our collaborative effort is to increase our overall donor conversion rate to 75% in our major trauma hospitals. That would mean that 75% of the potential donors turn into actual donors."

Weighing in on disc disease treatments

ECRI (Plymouth Meeting, Pennsylvania), a nonprofit health services research and patient safety agency with more than 35 years experience in healthcare technology assessment, last month published its perspectives and predictions on the potential impact of two new treatments for severe chronic back pain from degenerative disc disease. Both disc nucleus replacement technology and total artificial disc technology are being developed as alternatives to traditional spinal fusion surgery, which requires a bone graft and can reduce spinal column movement and disc function.

Disc nucleus replacement technology uses minimally invasive surgical techniques to replace only the nucleus of the disc with a prosthesis, preserving the function of the surrounding tissue. Total artificial disc technology involves the surgical removal and replacement of the entire damaged or diseased disc with a prosthetic implant, and the procedure cannot be done with minimally invasive techniques. In its on-line Health Technology Forecast, ECRI predicts that disc nucleus replacement technology is likely to be used more extensively than total artificial disc technology because of its potential to be performed on a minimally invasive basis.

Although neither procedure has yet received FDA marketing approval, one artificial disc the Charite from DePuy Spine (Raynham, Massachusetts), a division of Johnson & Johnson (New Brunswick, New Jersey) was recommended for marketing approval by an FDA advisory committee in early June and according to ECRI is expected to receive FDA approval by midsummer.

However, the organization said that when and if disc nucleus replacement receives FDA marketing approval, it may prove to be substantially less expensive than either full disc replacement or traditional spinal fusion surgery because it is minimally invasive, whereas the other procedures are open surgeries that can cost $40,000 to $50,000. Disc nucleus replacement, according to ECRI's forecast, also is expected to diffuse more rapidly and more widely than artificial discs because it has fewer contraindications.

Israeli health funds told to cover genetic tests

The Israeli Ministry of Health notified all health funds, hospitals, and genetic and oncological institutes that the country's health funds (Kupat Holim) or HMOs are obligated by law to cover the costs of genetic testing in their basket of services. The alert specifically referred to blood tests for BRCA1 and BRCA2 genes for heath fund members defined as being at high risk for breast and ovarian cancer. "The ministry announced the decision to cover genetic tests a year ago (May 28, 2003)," said Yitzhak Berlovitz, associate director general and head of medical administration. "We sent the current flyer as an emphatic reminder," he told BBI, because so many of the funds opposed the coverage.

This opposition against placing genetic tests in the HMO basket of services began with their overall inclusion when the 1994 National Health Insurance Law came into effect. Berlovitz told BBI that it was always the understanding of the Health Ministry that future unspecified genetic tests would be included and the funds would be expected to cover them. "As medical knowledge advanced, we anticipated that more types of tests would be included in the basket if they were medically justified and performed in Israel."

Acknowledging that they will not receive any additional health taxes, Berlovitz said, "The HMOs can readily cover the NIS 400 [about $88] tests." He added, "The people of Israel have a right to these tests and all of the other diagnostics, counseling and therapy available." His concern is that most eligible patients are not availing themselves of the tests, while some have had to sue the health funds to get reimbursed. "All cases thus far were won by the patients because the attorney general's office backed the ministry's interpretation of the law, as we understood that in the long run, the tests will save everyone money." Berlovitz said, "We [the Health Ministry] cannot fine the health insurers, but patients can take them to labor court and they will get back their money."

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