Technology is dramatically changing the way disease management (DM) services are being delivered to the chronically ill, but the DM industry will have to find ways of coping with a host of legal, regulatory, and reimbursement issues before it can take full advantage of the gains.

     Telemedicine, innovative computer software, and the Internet are just some of the forces reshaping the market. These technological advances are enabling health-care providers to monitor patients and deliver care, particularly at the outpatient level, that is less expensive and of a higher quality, according to industry experts.

     But despite the excitement about the technological possibilities emerging in DM, there is concern about legal implications regarding patient confidentiality and medical malpractice liability. Several bills, for instance, have been introduced in Congress to deal with the patient confidentiality issue, although some observers expect them to go nowhere and the issue to be resolved by strict U.S. Department of Health and Human Services (HHS) regulations (see article, page 1).

     According to Cindy Trutanic, vice president of consultant Potomac Strategies International (PSI), Washington, D.C., there are also many regulatory and reimbursement issues related to the new technology.

     "There are questions related to what [the U.S. Health Care Financing Administration] will cover and what it won't . . . and then there is the patchwork of state laws that need to be addressed," she says. On the reimbursement side, it could be difficult for payors to determine who gets what, she adds. "What percentage of payment would go to the consulting physician in a telemedicine scenario? . . . . These are tough questions," she says.

New DM-Related Products from Vendors

     Bruce Kehr, M.D., chairman and CEO of InforMedix, Rockville, Md., tells DMN that these legal and regulatory issues will be solved as the industry matures. InforMedix manufactures and markets the Medi-Monitor system, which uses portable, patient-based telemedicine technologies that monitor medication compliance and electronically link patients and health-care providers.

     The Medi-Monitor system is used by patients with such conditions as congestive heart failure (CHF), organ transplantation, HIV/AIDS, and psychiatric disorders.

     "Electronic case management is definitely the emerging trend in disease management . . . but a great deal of this area is uncharted territory," he says. "It is currently estimated that about one-half of the several hundred million visiting nurse home visits per year are for cognitive services only. This leads to an enormous opportunity to provide these services remotely to patients via telemedicine technologies," Kehr says.

     His company recently announced that it has joined forces with Advantor Corporation and ResponseLink, two Orlando, Fla.-based technology companies. Under terms of the agreement, Advantor will manufacture Medi-Monitors, and ResponseLink will set up and operate a call-monitoring center to provide monitoring and secure database access for both patients and providers. These types of unions between technology companies and DM firms are becoming increasingly common, Kehr says.

     He contends that the need for telehealth technologies in home care and ambulatory settings is being driven by a "data void in outpatient disease management services." "We know that hundreds of billions of dollars are lost each year because clinicians are unable to monitor disease-state progression on a day-to-day basis, or between clinic visits. And yet chronic outpatient treatment is the fastest growing segment in health care," Kehr adds.

     "The market size for outpatient telehealth technologies, particularly those that monitor medication compliance in patients who are on complex medication regimens, is one hundred million chronic care patients in the U.S. alone, where 25 million of these patients are on three or more different medications to manage their conditions," he says.

     His sentiments are echoed by Tom Shoup, Ph.D., operations manager for Hewlett-Packard's (HP) New Clinical Ventures division. Shoup says that, about three years ago, HP recognized that the market for acute-care technology was somewhat stagnant. Yet there was a gaping hole in the technology for outpatient settings.

     "This led us to the development of a new remote measurement system for patients with congestive heart failure," Shoup says. HP's entrance into the DM market is something "totally new for us," but this development is just the beginning, he says. HP is planning on developing other "services" such as the new CHF monitoring system for other chronic diseases, although he declines to identify the possible areas.

     Shoup explains that, unlike its hospital-based business, which involves selling products, the new DM initiative is a service. "We will provide the patients with the monitoring devices and will teach them how to use this simple technology," he says.

     The new system consists of four devices that are positioned in a patient's home. They include a digital scale, a blood pressure cuff, an electrocardiogram recorder, and a "box-like" device. All of them are equipped with radios that transmit the information to a central data repository at the client's site.

     "The beauty of this system is that it is extremely simple and does not require a personal computer," he adds. HP is awaiting approval from the U.S. Food and Drug Administration for the transmitting device. Once the company gets the green light, it plans to offer the services to a variety of payors, including large physician group practices, managed care organizations, and academic medical centers. The clients would pay HP a per-member, per-month fee for the service.

     HP has conducted several clinical trials, including one that involved 14 patients at the University of Massachusetts Medical Center, Worcester. The 12-month trial that began in April 1998 produced some impressive results, says Shoup.

     The annual rate of hospital readmissions was 1.9 per patient per year during the 12 months prior to the study, he says, and this was reduced to 0.21 per patient per year during the study. The number of emergency room visits fell from six to two per patient per year, and the number of home-nursing visits decreased from 23 during the first two weeks of the study to six during the final two weeks.

     PSI's Trutanic has spent many years working on a variety of telehealth programs, including a telepsychiatry initiative that is being run at the Deaconess Medical Center in Billings, Mont., with a grant from the HHS Office of Rural Health.

     One of the biggest bonuses with telehealth technology, she says, is the ability to collect accurate outcomes and truly evaluate the value of interventions.

     She also sees great social value in the ability to provide access to people who may not have had the ability before to see the providers who are most appropriate.

     Using Montana as an example, Trutanic explains that there is only one psychiatrist in that state. Obviously, she says, use of this technology enables patients who need care to remain in the area and not travel miles to the nearest hospital or physician office.

Internet Provides Potential DM Breakthroughs

     The emergence of hundreds of health-related Internet sites also has had an impact on the management of disease, the experts say. Consumers can log on and get detailed information about their disease and the medications they have to take.

     In one of the newest examples of what can be done, DM vendor LifeMasters Supported SelfCare and consumer-health Internet specialist The Health Network this month jointly unveiled a plan to launch an Internet-based interactive health monitoring service for persons with chronic medical conditions.

     Through the service, which the two firms said is free to patients, individuals with such conditions as diabetes, asthma, and heart ailments will enter their vital signs and symptoms from a personal computer into a home page at TheHealthNetwork.com. Based on this input, LifeMasters will provide personalized feedback on the patients' health status through use of charts, graphs, and physician-written guides to assist in managing their particular symptoms.

     Patients paying to subscribe to a separate, premium service will receive feedback directly from clinical nurse consultants, who will monitor the information and alert patients' physicians when circumstances indicate the need for medical information, the firms said.

     Another DM firm using Internet technology, New York-based SoftCARE (formerly Discover Recovery Solutions), uses "second-level" health risk assessment questionnaires to stratify patients into mild, moderate, and severe disease categories. John Roglieri, M.D., SoftCARE's chief medical officer, says the questionnaires also distinguish those patients whose clinical condition is stable from those who are unstable, thereby helping to determine the frequency of needed SoftCARE monitoring and educational contact.

     The system also includes SoftCARE Chat, which allows members to speak directly with each other and with a group leader over the Internet. "In other words," says Roglieri, "kids logging on to an asthma chat room, for example, do not have to type their comments, nor do they have to read the input of others." They simply use an avatar to represent them visually in the chat room and then see that avatar become animated (i.e., speak their voices) each time they speak into their computer microphones.

Concerns About Use of Internet for DM

     Trutanic and PSI President Ray Dubois believe that the use of the Internet for DM has pros and cons. "While an educated consumer is a better consumer, not all of the information on the Internet is good, accurate information," Dubois says.

     "You can look at the issue of the Internet in from two points of view," he says. "The fact that technology is driving the dissemination of information and is empowering doctors, nurses, and patients is good. But bad information is dangerous."

     He maintains that patients should rely on the "brands you know" approach and stick to sites that are recognized as experts such as those of the federal Centers for Disease Control and Prevention, National Institutes of Health, and academic medical center portals.

     Trutanic adds that the use of the Internet for the transfer of patient information also causes concern. Patient confidentiality is crucial to the success of the Internet as a DM tool, she says, because "people are extremely sensitive about their medical histories, as they should be."

     PSI works with several clients, including Member-Link Systems Inc. (MLS), a Washington, D.C.-based company that recently announced the development of Medicive Medical Enterprise Data System, a software suite that handles all data related to operating one or many medical facilities.

     The Medicive system is divided into modules that address the specific needs of health-care providers in a particular specialty. Each module's user interface - such as AsthmaWatch, an asthma DM program - was designed by physicians and specialists. MLS offers the Asthma-Watch System on a secure Internet World Wide Web site.

     "We have designed the system to communicate with both legacy and current medical data systems that are in place in the health-care facilities," Trutanic says. The program receives from these systems a master patient index that includes the patient name, address, telephone, insurance providers, and other relevant demographic information as well as laboratory results.

     "This communication interface allows AsthmaWatch to accept patient identifiers from the institution's system and in turn create its own identifier to assure data integrity," she adds. "If the provider program sees a patient that is not in the system, AsthmaWatch adds this patient, assigns an appropriate identifier, and can update the institution's systems simultaneously."

     The system was developed in conjunction with the Division of Allergy and Immunology at the LAC+USC Medical Center in Los Angeles. Trutanic says it was developed to help in the standardization of protocols and to collect detailed information on treatment outcomes and compliance issues. Information is collected on portable Breathmobiles as well as in the fixed clinics at the medical center.

     Systems such as AsthmaWatch, according to Trutanic, are becoming increasingly common in the DM arena. "The technology is only going to keep on improving and becoming more sophisticated," she says. But she stresses that, in order for it to gain system-wide acceptance, the legal, regulatory, and reimbursement issues need to be solved. - Jayne Whalley-Hill