Health Technology TRENDS

Transcription

1 Health Technology TRENDS IN THIS ISSUE Choosing Wisely. The American Board of Internal Medicine (ABIM) Foundation recently published a list of potentially wasteful diagnostic and therapeutic treatments in conjunction with medical specialty societies. We talk with the ABIM Foundation s executive vice president and chief operating officer about what the recommendations mean to patients and doctors. page 1 Editorial. Curious about the evidence behind the Choosing Wisely recommendations? ECRI Institute can help with PubMed search resources. ECRI Institute s president and chief executive officer discusses why this initiative is important. page 2 Laboratory-developed tests. An Institute of Medicine report highlights a lively roundtable discussion among stakeholders on laboratory-developed tests. page 4 CMS on nerve stimulators. The U.S. Centers for Medicare & Medicaid Services is proposing to cease coverage of transcutaneous electrical nerve stimulation therapy used to treat patients with chronic low back pain. page 7 Remote patient monitoring. Industry experts predict continued growth in remote patient monitoring services as hospital readmission penalties loom on the reimbursement front and device technologies advance. page 8 Reimbursement of telehealth. The U.S. Department of Health and Human Services prepared a factsheet that addresses reimbursement eligibility for remote patient monitoring and related telehealth services. page 11 Interoperability and telehealth. One nonprofit organization s open-industry model is promoting interoperability with its test and certification program. page 11 In upcoming issues What s happening with comparative effectiveness research? Waste in healthcare from the specialist s chair Unnecessary computed tomography (CT) scans and magnetic resonance imaging exams, overzealous antibiotic prescribing, and cancer treatment or screening in poorprognosis patients are all things that the U.S. government and private healthcare insurers would like to stop. But efforts to curtail overuse of diagnostics and therapeutics have been met with skepticism that economic interests trump patients best interests. Now physician leadership in the form of medical specialty societies supported by the American Board of Internal Medicine (ABIM) Foundation are taking a stand with the list. The list The list of 45 recommendations against unnecessary tests and treatments from 9 medical specialty societies was announced as part of the Choosing Wisely campaign on April 4, 2012, at a national event in Washington, D.C. According to Christine K. Cassel, M.D., president of ABIM Foundation, the medical waste message is directed to doctors and patients. She and James A. Guest, J.D., president and chief executive officer of Consumer Reports, a partner in Choosing Wisely, laid the groundwork for the initiative in an editorial published in the Journal of the American Medical Association (2012 April 4[Epub ahead of print]). Each medical society s list includes five items (diagnostic tests and treatments) physicians and patients should question. The participating societies include: American Academy of Allergy, Asthma & Immunology American Academy of Family Physicians April 2012 Vol. 24, No. 4 American College of Cardiology American College of Physicians American College of Radiology American Gastroenterological Association American Society of Clinical Oncology American Society of Nephrology American Society of Nuclear Cardiology Give me five Daniel B. Wolfson, M.H.S.A., executive vice president and chief operating officer of ABIM Foundation, said the idea of the top five list for each specialty comes in part from an article by Howard Brody, M.D., Ph.D., director of the Institute for the Medical Humanities at the University of Texas Medical Branch (Galveston, TX, USA). This was during healthcare reform efforts, and he was prodding physicians to take a more active role in reform, suggesting that they identify five things that are wasteful, recalled Wolfson. Brody s suggested top five list included recommendations against diagnostic tests or treatments that are very commonly ordered by members of that specialty, are among the most expensive, and lack evidence of a meaningful benefit. His examples included arthroscopic surgery for knee osteoarthritis and CT scans (N Engl J Med Jan 28;362[4]: ). Wolfson also referenced efforts from the National Physicians Alliance (NPA). NPA s Promoting Good Stewardship in Medicine was sponsored by an ABIM Choosing Wisely (continued on page 3) 5200 Butler Pike, Plymouth Meeting, PA , USA Tel +1 (610) Fax +1 (610) Web info@ecri.org

2 Summary Industry experts predict continued growth in remote patient monitoring services as hospital readmission penalties loom on the reimbursement front and device technologies advance. People are concerned about lowering the cost of healthcare because of the large increases they have seen from year to year. Remote patient monitoring industry grows as hospitalization costs rise As the U.S. population ages, home care is an increasingly popular alternative to longterm hospital stays. According to a March 2012 report from GBI Research, this is a global trend. Global Patient Monitoring Devices Market to 2017 projects a compound annual growth rate of 4% for the market, which is expected to reach $8 billion by 2017 from $6.1 billion in Growth is attributed to rising healthcare costs and increased rates of chronic disease. Today s lightweight, user-friendly vital sign monitors with remote capabilities also help. In the United States, telehealth providers are offering their services to Accountable Care Organizations, insurers, and hospitals. Hospitals are keenly interested because they want to avoid Medicare rehospitalization penalties that become effective October Most patients would choose home care over extended hospital stays, but home care has its own set of challenges. We look at how U.S. regulators and government advisors propose to address the challenges of caregivers and users of home health devices, including device usability, varying home environments, and standardization/ interoperability issues related to device integration with hospital systems. Hospitalization costs According to the National Association for Home Care and Hospice (NAHC), home care can result in significant savings. According to NAHC s 2008 data, hospital costs for ventilator-dependent adults at one month total $21,570 versus $7,050 for home care costs. One month of inpatient care for a child on chemotherapy is $68,870 versus $55,950 for home care. One month of inpatient intervenous therapy is $12,510 versus $4,650 for home care. Home care can also prevent readmissions, according to Karen R. Thomas, M.B.A., C.M.A., president, Advanced TeleHealth Solutions, a subsidiary of Oxford HealthCare (Springfield, MO, USA). We re seeing interest in [our service] from those groups who are financially at risk, she explained, referring to Medicare s policy to penalize hospitals for readmissions. People are concerned about lowering the cost of healthcare because of the large increases they have seen from year to year. Her company plans to publish data on its clients to document reduced hospitalizations and related savings looking at 30-day rehospitalization rates with a 6-month follow-up in a telehealth-monitored group compared to a control group (data were not available at press time). Telehealth today Remote patient monitoring is just one aspect of telehealth. The American Telemedicine Association (ATA) considers the terms telemedicine and telehealth interchangeable, although some in the industry prefer the latter term as the practice broadens. For example, teleconsulting and telementoring via teleconferencing have gained popularity in institutions to remotely tap into expertise. As a prominent industry trade organization, ATA has been championing telehealth, lobbying U.S. Congress, policymakers, and payers for support. ATA is lobbying Congress to remove one of the two longest reigning barriers to diffusion of telehealth: state licensure barriers for physicians practicing across state lines. The other barrier has been lack of a reimbursement structure to facilitate billing for telehealth services. To that end, ATA has been pushing for Current Procedural Terminology codes and proposed to the U.S. Centers for Medicare & Medicaid Services (CMS) that its Conditions of Participation for hospitals include provisions for teleconferencing to account for staff in key service areas like emergency rooms and intensive care units. On the Medicare front, telehealth offers some advantages for managing chronic conditions such as diabetes, hypertension, and congestive heart failure (CHF). Home care organizations like Oxford HealthCare have become early adopters of remote Remote patient monitoring (continued on page 10) ECRI Institute. May be reproduced by member institution only for distribution within its own facility. APRIL 2012

3 Managing telehealth on the other end is the ability to know when something is an emergency. patient monitoring technology. We actually started using telehealth in 2002, explained Thomas. It was really quite new. Our original intent was to assist with the nursing shortage and to provide good care documented, evidenced-based care to our patients with a look towards reducing our costs. Thomas said they started using a Honeywell HomMed, LLC (Brookfield, WI, USA) device. We were placing the devices in the home, and we were able to monitor weight up to 500 pounds with a scale that leveled to adapt to a floor in the home, as well as heart rate, blood pressure, glucose, pulse [oximetry] and PT/INR [prothrombin time/international normalized ratio] for patients taking warfarin. Thomas said data were originally transmitted via telephone line or satellite, then triaged based on the patient s own parameters. Anytime a patient s vital signs were outside of their normal range, they were triaged to the top for follow-up from clinical staff. The incredible shrinking device Things have changed since then. For starters, the devices have gotten smaller and more easily transportable for the client, observed Thomas, adding that some are even simpler to use and resemble ipads in design. Many of these systems rely on cloud storage, which offers secure password access of data remotely. Honeywell HomMed s latest remote patient monitoring device, the Genesis Touch, is an Android-based vital signs monitor that accepts patient information (e.g., heart rate, blood pressure, glucose levels, pulse oximetry, PT/INR). On the provider side, software supports the device, and vitals data can be transferred in real time for clinicians to access. Philips Remote Patient Monitoring Solutions (Philips Healthcare, Andover, MA, USA) consists of several small wireless devices. Patients take their own vital-sign measurements and respond to cliniciandirected surveys via TeleStation, the in-home communication device. Data are transmitted remotely to the Philips Clinical Review Application intended for clinician access. GBI s report on remote patient monitoring predicts that key device players in this market include Philips Healthcare, Omron Healthcare Co. (Lake Forest, IL, USA), and GE Healthcare (Princeton, NJ, USA). The Intel-GE Care Innovations Guide is the remote monitoring solution Humana, Inc. (Wilmington, DE, USA) chose for a large CHF patient-monitoring pilot project with its subsidiary Humana Cares and Care Innovations, an Intel Company (Santa Clara, CA, USA). According to remote-health monitoring service provider Trapollo, LLC. (Sterling, VA, USA), the project launched in January The company oversaw technology installation in 1,600 Medicare recipient homes. Unlike standalone solutions, the software, which received U.S. Food and Drug Administration (FDA) clearance, can be installed on any device that runs Microsoft Windows 7 (e.g., notebooks, tablets, desktop computers) and enables video conferencing. The technology requires a separate blood pressure monitor and weight scale peripherals. Each different type of equipment has good qualities, said Thomas. It s a matter of knowing you re getting good results and testing it periodically. She also stressed the importance of selecting devices with FDA marketing clearance. Yet, as sophisticated as these systems are, they require a care team and established workflow protocols to manage data and patient follow-up. Managing telehealth on the other end is the ability to know when something is an emergency, said Thomas. It involves excellent triage and decision skills. Thomas said their chronic-carecertified nurses undergo a training program that involves learning how to educate the client. We really customize our programs to meet the goals of the group we re working with. Regulating home devices Remote patient monitoring devices fall under FDA s definition of home devices, which are intended for users in any environment, apart from the professional healthcare facility or emergency medical services, which may require training for the user by a qualified healthcare professional to assure safe and effective use. In April 2010, FDA published its Medical Device Home Use Initiative announcing plans to develop guidelines for manufacturers of home health devices, develop a home APRIL ECRI Institute. May be reproduced by member institution only for distribution within its own facility. 9

4 health labeling repository, and partner with home health accrediting bodies to ensure safety of devices. It also announced plans to enhance postmarket oversight and increase public awareness and education related to home health issues. FDA held a workshop on these initiatives on May 24, 2010, and feedback from the event informed its June 2011 webinar* on its continued efforts in this area. Human factors The 2011 National Research Council report** Health Care Comes Home: The Human Factors mirrors some of FDA s concerns but addresses the larger home health picture, looking at four specific areas: the devices and technology associated with this kind of care, caregivers and care recipients, resident environments for care, and research and development needs. For example, the workgroup concluded in part that: FDA should certify home health devices and systems that integrate devices with health information technology. FDA should promote the development of standards bodies for this category of devices and provide guidance to developers. FDA should improve adverse-event reporting systems for lay users. Relevant professional practice and advocacy groups should develop appropriate certification, credentialing, and training. Report authors also found wide variation in the home environments of home device users and recommended that federal agencies such as the U.S. Department of Health and Human Services, CMS, and the U.S. Department of Housing and Urban Development convene to develop guidelines that address residential zoning and new construction requirements that account for disability and home care needs. *A PowerPoint presentation on FDA s June 2011 webinar is available at: downloads/aboutfda/transparency/basics/ UCM pdf ** National Research Council. (2011). Health Care Comes Home: The Human Factors. Committee on the Role of Human Factors in Home Health Care, Board on Human-Systems Integration, Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press. On the research and development front, report authors found the industry has ample knowledge of device technology but lacks uniform application of such knowledge. In response, authors recommended that the U.S. Agency for Healthcare Research and Quality collaborate with other government agencies such as the U.S. Department of Veterans Affairs and CMS to support human factors research to better match appropriate devices to patient needs. The report also called for these agencies to develop assessment tools customized for home-based healthcare. As more devices become integrated with information systems, report authors observed the emergence of consumer health informatics (CHIs) tools, and CHI-related issues: Importantly, interactions between the [CHI] tools available to care recipients and the electronic health records that primary care providers and hospitals use raise issues that have a direct impact on healthcare in the home. Two of these issues are data ownership and data reliability. Finally, authors voiced concern regarding the interoperability of numerous home care devices, such as medication-dispensing systems, infusion pumps, mobility assistive devices, wearable monitoring and reminding devices, robots (stationary or mobile), and environmental sensors. According to authors: In applications such as these, the challenges of interoperability among devices, systems, and information sources will be especially important. If there is no way to ensure that the components, whatever their origins or providers, are designed from the beginning to work together, it may be very difficult to implement effective systems. Thomas acknowledged the need for standards in home care devices. There is still a ways to go, she said of today s devices. Standardization is not there. I think there needs to be a minimal set of standards, and part of that will fall on the industry ECRI Institute. May be reproduced by member institution only for distribution within its own facility. APRIL 2012

5 Reimbursement of remote patient monitoring Medicare will pay for a limited number of Part B services that are furnished by a physician or practitioner to an eligible benefi ciary via a telecommunications system. Read more about reimbursement eligibility in this Telehealth Services Fact Sheet: TelehealthSrvcsfctsht.pdf Interoperability and remote patient monitoring devices As more health devices are connected to information systems across care settings, biomedical engineers and health information technology professionals face myriad connectivity and interoperability issues. To that end, the work of Continua Health Alliance (Beaverton, OR, USA) bears mention as a nonprofi t open industry organization. Continua s 240 members include health information technology companies, pharmaceutical companies, technology giants, healthcare providers, payers, and others. The annual membership fee for promoters runs $25,000; contributors and supporting participants pay $6,500. Members participate in workgroups as well as the test and certifi cation program for health monitoring devices, software, and related systems. Members who pay for and pass the test and certifi cation program can use the Certifi ed Continua Logo indicating interoperability with other certifi ed products. The company also offers matchmaking services for healthcare service providers and device manufacturers. Read more about Continua Health Alliance at: Laboratory-developed tests (continued from page 6) framework will be risk-based, looking at the intended use of devices and regulating by risk, Harper said. This very phased-in approach would start with high-risk class III devices, she said. Once we got those under control, we would begin to look at more moderate-risk tests. But the expectation is that this approach would not take one or two years it will likely be more like 15 to 20 years. Once FDA releases the draft guidance on LDT regulation, Harper said she encourages stakeholders to attend agency meetings and submit comments. We re going to make sure that this is a very open, transparent process where we hear from all stakeholders. APRIL ECRI Institute. May be reproduced by member institution only for distribution within its own facility. 11