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Professor Vernellia Randall
The University of Dayton School of Law
This course was planned but never taught.
Introduction to E-health
Gunther Eysenbach Editor, Journal of Medical Internet Research
Everybody talks about e-health these days, but few people have come up with a clear definition of this comparatively new term. Barely in use before 1999, this term now seems to serve as a general "buzzword," used to characterize not only "Internet medicine", but also virtually everything related to computers and medicine. The term was apparently first used by industry leaders and marketing people rather than academics. They created and used this term in line with other "e-words" such as e-commerce, e-business, e-solutions, and so on, in an attempt to convey the promises, principles, excitement (and hype) around e-commerce (electronic commerce) to the health arena, and to give an account of the new possibilities the Internet is opening up to the area of health care. Intel, for example, referred to e-health as "a concerted effort undertaken by leaders in health care and hi-tech industries to fully harness the benefits available through the convergence of the Internet and health care." Because the Internet created new opportunities and challenges to the traditional health care information technology industry, the use of a new term to address these issues seemed appropriate. These "new" challenges for the health care information technology industry were mainly (1) the capability of consumers to interact with their systems online (B2C = "business to consumer"); (2) improved possibilities for institution-to-institution transmissions of data (B2B = "business to business"); (3) new possibilities for peer-to-peer communication of consumers (C2C = "consumer to consumer").
So, how can we define e-health in the academic environment? One JMIR Editorial Board member feels that the term should remain in the realm of the business and marketing sector and should be avoided in scientific medical literature and discourse. However, the term has already entered the scientific literature (today, 76 Medline-indexed articles contain the term "e-health" in the title or abstract). What remains to be done is in good scholarly tradition to define as well as possible what we are talking about. However, as another member of the Editorial Board noted, "stamping a definition on something like e-health is somewhat like stamping a definition on 'the Internet': It is defined how it is used - the definition cannot be pinned down, as it is a dynamic environment, constantly moving."
It seems quite clear that e-health encompasses more than a mere technological development. I would define the term and concept as follows:
e-health is an emerging field in the intersection of medical informatics, public health and business, referring to health services and information delivered or enhanced through the Internet and related technologies. In a broader sense, the term characterizes not only a technical development, but also a state-of-mind, a way of thinking, an attitude, and a commitment for networked, global thinking, to improve health care locally, regionally, and worldwide by using information and communication technology.
This definition hopefully is broad enough to apply to a dynamic environment such as the Internet and at the same time acknowledges that e-health encompasses more than just "Internet and Medicine".
As such, the "e" in e-health does not only stand for "electronic," but implies a number of other "es," which together perhaps best characterize what e-health is all about (or what it should be). Last, but not least, all of these have been (or will be) issues addressed in articles published in the Journal of Medical Internet Research
2001 Report to Congress on Telemedicine, Office for Advancement of TeleHealth, (Last visited: March 17, 2003)
High transmission cost continues to deter telemedicine, particularly in rural areas of the United States. While it may be only a few years away, competition in telecommunications service has not yet reached much of rural America and transmission cost is still a significant part of a rural telemedicine project's overall budget.
Five years ago Congress passed the landmark Telecommunications Act of 1996 (the Act), providing a blueprint for major changes in the telecommunications industry, such as opening up competition between long distance carriers and the Regional Bell Operating Companies. The Act also stated that rural health care providers (HCPs) should have access to advanced telecommunications services at reduced rates.
In the Act, Congress charged the Federal Communications Commission (FCC) with administering the Universal Service program that would provide rural health care providers with a discount on their telecommunication transmission charges equaling the difference between urban and rural transmission rates. In 1997, the FCC established the Universal Service Administrative Company, (USAC) a separate, not for profit entity, which oversees both the E-Rate discount for Schools and Libraries and the Rural Health Care Program (RHCD).
After a number of false starts, the Rural Health Care Program issued its first funding commitments on June 25, 1999, five days before the end of the first 18-month program year. In total, 483 rural health care providers received $3.4 million out of a possible $400 million, which equaled the total requested support for completed applications received by USAC that year (January 1, 1998 through June 30, 1999).
Since then, the FCC has adopted a number of reforms to the program, as outlined below, which streamline the discount application process, and address practical concerns voiced by practitioners and others. Specifically, the FCC:
***Expanded the list of telecommunication carriers eligible to participate in the program to include non-ETC (long distance) carriers;
***Streamlined the application process;
***Changed the discount calculation to distance based charges paid by rural healthcare providers rather than a comparison of urban and rural published tariffs; and Eliminated bandwidth and quantity limits so that any bandwidth and any number of services could be supported.
Funding in the second year of program, after reforms were implemented, increased to approximately $6.1 million. Moreover the FCC and USAC expect that third-year funding figures will increase to nearly $10 million, once all reforms have been in place for a full year. (For a detailed history of the Rural Health Care Division, see Appendix 6 and OAT's FCC filing on Universal Service at http://telehealth.hrsa.gov/pubs.htm.)
***The Office for the Advancement of Telehealth (OAT) recently filed comments with the FCC on the question of "possible impediments to deployment and subscribership in unserved and underserved areas of the nation." (See OAT's FCC filing on Pacific Basin at http://telehealth.hrsa.gov/pubs.htm) Follow-up with the FCC on this issue continues.
***OAT also filed comments on the FCC's proposal to set aside spectrum for the use of Wireless Medical Telemetry. (See http://telehealth.hrsa.gov/pubs.htm) OAT's comments also reflected concern about adequate spectrum for future telemedicine applications, which may require more bandwidth than currently allocated for telemetry.
Evaluation and Research
2001 Report to Congress on Telemedicine, Office for Advancement of TeleHealth, (Last visited: March 17, 2003)
***Patient and Physician Satisfaction with Telemedicine Table 4: Patient/Provider Satisfaction with Telemedicine Box 8: ECU Study Results
***Telemedicine Cost Savings Box 9: Kaiser Tele-homecare Study Results
Despite telemedicine's relatively long history, few statistically significant studies of efficacy, patient/physician satisfaction, or effectiveness have been conducted. This dearth of research and data may be due in part to the relatively small number of telemedicine consultations within a given specialty or across specialties within individual telemedicine projects, and to the lack of a standard methodology to study efficacy, patient/physician satisfaction, or effectiveness across projects.
Despite the lack of statistical significance in most of the studies examined by this Report, all showed high patient satisfaction with telemedicine as shown in Table 4. Provider satisfaction was more variable, but generally moderate to high. Moreover, although one cannot generalize to all telemedicine applications, studies of specific services, such as tele-homecare and tele-dermatology, suggest that at least for these services, there may be real cost savings to be realized from telemedicine.
Recent research on evaluation methodologies, such as the Lewin Group Inc.'s draft study on the Assessment of Approaches to Evaluating Telemedicine, funded by the Office of the Assistant Secretary for Planning and Evaluation, the Department of Health and Human Services (DHHS), may offer hope for more statistically robust studies in the near future.
Patient and Physician Satisfaction with Telemedicine
To develop a better sense of patient and physician satisfaction, this Report to Congress examined four recent reviews of studies on patient and/or provider satisfaction with telemedicine. These reports offer sufficient breadth or depth in their data to warrant a closer look. Table 4 below highlights the general findings and the strengths and weaknesses of the reports. They include:
*** Telemedicine for the Medicare Population by the Oregon Health Sciences University funded by the Agency for Healthcare Research and Quality for DHHS;
***Patient Satisfaction with Telemedicine by the East Carolina University Medical School Telemedicine Center;
***A DRAFT Assessment of Approaches to Evaluating Telemedicine by the Lewin Group, Inc, funded by the Office of the Assistant Secretary for Planning and Evaluation; and
***The 1999 Annual Report of the Association of Telehealth Service Providers. Table 4: Studies of Patient/Physician Satisfaction with Telemedicine Name of Report No. of Studies Reviewed Patient Satisfaction Provider Satisfaction Strengths/ Weaknesses DHHS/Oregon Health Sciences University (2000) 30 studies Highly Satisfied HighlySatisfied Large survey of studies/ small data samples in each study. Studies only look at one application such as teledermatology East Carolina University (2000) 12 studies plus ECU study of 492 teleconsults HighlySatisfied 98.3% Rating NA Large data sample in ECU study with different applications and different settings/ small survey of 12 other studies with small data samples. Association of Telehealth Service Providers (1999) Study based on 132 network responses NA Moderate to Highly Satisfied Large survey of users/ only looks at technology and users Oregon Health Sciences University/DHHS Report
In 1999, the DHHS' Agency for Healthcare Research and Quality funded the Oregon Health Sciences University to study Telemedicine for the Medicare Population. The Report assesses telemedicine technologies that substitute for face-to-face medical diagnosis and treatment, focusing on three technologies -- store and forward, self-monitoring/testing and non-surgical services.
Although the main thrust of the Oregon Health Sciences University's report is telemedicine technologies and not patient/physician satisfaction with telemedicine, the authors devoted a chapter to their findings on satisfaction.
This chapter drew upon an extensive literature search of both ongoing telemedicine programs around the world and peer reviewed studies assessing the efficacy and cost of telemedicine. The survey of telemedicine literature and projects was extensive and about 30 studies fit the authors' criteria for inclusion in the patient/physician satisfaction chapter. The authors selected 18 studies that examined patient satisfaction with telemedicine and 10 studies that looked at physician satisfaction. Most of these focused on one clinical specialty such as oncology, psychiatry or dermatology, or on a particular setting such as a prison or emergency room.
The majority of the Report's selected studies show patients satisfied with their telemedicine treatment. Out of 18 studies examined, only one study showed that most patients preferred face to face assessment in lieu of teleconsults. The rest of the studies reveal high levels of satisfaction.
Similarly, the Report found that, overall, physicians' satisfaction ranges from "satisfied" with telemedicine technical quality to high levels of satisfaction. However, one study out of the ten showed that while the participating psychiatrists were satisfied, given a choice, they preferred face to face assessments.
Despite these positive outcomes, the Oregon Health Sciences University does not draw any conclusions about patient or physician satisfaction because the authors felt that the studies were not statistically significant. However, the authors do acknowledge that further study or more statistically significant study may not provide any different conclusions than those already offered by these.
As shown in Table 4, most of the studies were based on relatively small data sample sizes ranging from one to about 100 patients. Two of the 18 patient studies were based on larger sample sizes. One was based on a prison inmate population of 576 inmates; the other was based on a sample of 294 dermatological patients. Most of the studies concentrated on only one specialty such as mental health or dermatology. A few studies did assess satisfaction across a few specialties but these were the exception.
Telemedicine Center of the East Carolina University School of Medicine
The University of East Carolina (ECU) School of Medicine recently published a report entitled "Patient Satisfaction with Telemedicine," in the Telemedicine Journal (Vol. 5, Num.1). In this report, the authors review other non-telemedicine studies that look at patient satisfaction as well as 12 studies of patient satisfaction in telemedicine applications. They also report their own findings about patient satisfaction based on data collected and evaluated from 495 real-time interactive telemedicine clinical consultations associated with their Telemedicine Center at the School of Medicine. ECU's Telemedicine Center is the hub to eight spoke sites, including six hospitals, one rural health clinic and one maximum-security prison.
ECU's review of 12 telemedicine studies showed patient satisfaction ranging between 71% to 100%. And similar to the Oregon Health Sciences University's review of 18 telemedicine studies, above, ECU found that the 12 telemedicine studies they reviewed tended to have small sample sizes, ranging from 21 to 292 patients. Also similar to the DHHS studies was the focus on one clinical specialty or particular setting, such as a prison.
Box 8: ECU Study Results
Overall patient satisfaction with telemedicine applications was found to be a high 98.3%. Patients were highly satisfied with consultations through telemedicine, and reported that care was easier to obtain.
In contrast to the reviewed studies, the ECU study has a much larger data sample size (495 responses) and looks at patient satisfaction across telemedicine specialties. ECU studied a wide variety of clinical specialists including dermatology (33.5%), allergy (21%), cardiology (17%), psychiatry (5.1%), endocrinology (4.2%) and rehabilitation medicine (4.0%).
Patient satisfaction was examined in relation to patient age, gender, race, income and insurance. Overall patient satisfaction with telemedicine applications was found to be a high 98.3%. Patients were highly satisfied with consultations through telemedicine and reported that care was easier to obtain.
ECU suggests several reasons for the high patient satisfaction rate. For example, travel time can be a factor in patient satisfaction. Travel distances for patients seen over the telemedicine link were on average 81 percent shorter, when compared to the distance to the School of Medicine clinics. The overwhelming majority of patients indicated that telemedicine had made it easier for them to obtain medical care. For example, scheduling a time to see a telemedicine specialist was easier than trying to schedule an appointment with a traditional specialist at ECU's clinics. The amount of time the telemedicine specialist spent on a patient's interview, physical examination and discussion of treatment options was greater and more satisfying to the patient. Part of the reason was that the telemedicine physician received patient information several days prior to the consultation and spent less time gathering information about medical history and more time on the problem at hand. According to the ECU study, although the telemedicine consult usually takes longer than a traditional exam, "it is plausible that these factors make the patient feel more involved in the consultation and increase(s) satisfaction in the process."
Association of Telehealth Service Providers
The Association of Telehealth Service Providers' (ATSP) annual report provides findings from a nation wide survey of active telehealth networks. The purpose of the 1999 Report on US Telemedicine Activity, was to assess the state of telemedicine from the clinical provider's organizational perspective; describe and characterize telemedicine/telehealth activity for 1998 and the first quarter of 1999; and provide reference material. The report does not include patient or physician satisfaction with telemedicine per se but does survey clinical providers' satisfaction with specific types of telemedicine technology. ATSP's 1999 report is based on responses from 132 telehealth networks.
In this report, ATSP's findings on provider satisfaction of telemedicine technology could be viewed as a proxy for health provider satisfaction with telemedicine. The report shows clinical providers' satisfaction with several types of telemedicine technology with data from about 4 to 69 users. Overall the majority (94%) of those interviewed indicated moderate to high levels of satisfaction with the different types of equipment used for telemedicine such as teleradiology, telepathology, videoconferencing, laptops, set tops, home health systems.
Overall, each of these reports and the studies they review or the programs they survey show that patient satisfaction with telemedicine is high and that physician satisfaction is moderate to high. Despite the lack of statistically significant data underpinning most of the studies, it is notable that they all show positive satisfaction.
The Office of the Assistant Secretary for Planning and Evaluation/ Lewin Group, Inc. Report
The Office of the Assistant Secretary for Planning and Evaluation(OASPE) of the DHHS funded Lewin Group Inc. has drafted a report titled Assessment of Approaches to Evaluating Telemedicine. This draft highlights some of the difficulties of evaluating an industry driven by rapidly changing technology and, given these difficulties, reviews the frameworks needed to appropriately evalutate telemedicine projects. For the report, Lewin conducted a literature search on a number of telemedicine studies and visited five telemedicine sites, first hand. Additionally, 15 telemedicine experts were extensively interviewed. Although the main purpose of the report was assessing telemedicine evaluation and not patient satisfaction with telemedicine, it does address what subjects should be appraised in the future and what subjects, such as patient satisfaction, may be sufficiently evaluated.
As the Lewin Group Inc.'s Draft Report points out "patient satisfaction with telemedicine has consistently been demonstrated to be high. As such, resources for future evaluations may be better allocated to areas of higher priority."
Telemedicine Cost Savings Box 9: Kaiser Tele-homecare Study Results
The Study found no difference in quality indicators, patient satisfaction or use between a control group and a tele-homecare group. Although the average direct cost for home health services was $1,830 in the tele-home group and $1,167 in the control group, the total mean costs of care, excluding home health care costs, were $1,948 in the tele-home group and $2,674 in the control group.
Just as there has been an absence of statically significant studies about patient/ provider satisfaction, at present, few telemedicine or other health care projects track the number of patients, who would have been denied access to health care, died or suffered grave consequences in the absence of telemedicine services. As for other tangible benefits related to telemedicine services, they too have not been systematically studied across telemedicine applications on a large scale.
This report briefly looks at several studies that examine telemedicine cost savings for a specific telemedicine application. Kaiser Permanente Medical Center of Sacramento, California conducted an in-depth study on tele-homecare 11 between 1996 to 1997. (See http://www.archfammed.com). In the cost control study home-care patients were assigned to two different groups: a telemedicine intervention group and a control group. The telemedicine intervention group included 102 patients, who had access to a remote video system that allowed nurses and patients to interact in real time; the control group included 110 home health patients, who were visited by nurses. The study showed that remote video technology in the home care setting was effective and well received by patients. Moreover, the quality of care provided by this technology yielded similar outcomes to those of the control group. Finally, the study found that tele-homecare had the potential for cost savings, which was mostly attributable to hospitalization cost reduction as shown in Box 9.
The University of Tennessee Medical School (UT) also published a study on tele-homecare, conducted between April 1998 and June 1999. UT's A Case Study of Benefits and Potential Savings in Rural Home Telemedicine12 evaluated 444 tele-home health visits to 14 patients using the Home Touch* system. The Home Touch system included a 13-inch monitor, a speaker phone, a camera and ViaTV converter equipment to provide a real-time home health consultation with UT Home Health nurses in both Knoxville and Jefferson City. The cost of the system was about $1,500. UT conducted in-depth interviews and monthly surveys with nine of the 14 patients, as well as their caregivers. The results from the Case Study show that:
*** 98% of the patients were satisfied with telemedicine;
***100% said the equipment was easy to use;
***Use of the Home Touch program saved more than 27,000 nurse travel miles between April '98 and June '99, representing potential savings of $7,091.76 @ $0.26/mile;
***For the 14 patients seen by telemedicine, the mileage reimbursement and drive time potential savings were $49.33 per visit.
The Walter Reed Army Medical Center's (WRAMC) Army Telemedicine Directorate recently evaluated the use of teledermatology for several military sites. Although actual travel and dermatology contract costs for the different military locations were not available, the study found that teledermatology's current benefits are "reduced travel and contract dermatologist costs, increased Primary Care Manager (PCM) education, increased access to dermatologists and increased patient/provider satisfaction"13. This study was based upon findings from WRAMC's Web-Based Telemedicine Consult Management System (TCMS) for teledermatology which conducted 108 clinical consults between April 22, 1998 and July 15, 1998.
Finally, the OASPE/ Lewin Group Inc.'s report findings suggest that "some of the commonly recognized types of economic impact of telemedicine applications are costs associated with: patient time and productivity; transportation; capital (equipment, space, etc.); maintenance; and communications; utilization of health care services; and staffing levels and productivity of health professionals."
*** Future evaluations might use the results of the OASPE/Lewin Group Inc. Report to conduct research that yields data with greater statistical significance, by using cross-project evaluation methodologies suggested in the Report.
***Future evaluations should examine provider satisfaction, quality and cost implications of telemedicine for specific applications such as tele-homecare, teledermatology and mental health. Footnotes
Emerging Trends and Policy
2001 Report to Congress on Telemedicine, Office for Advancement of TeleHealth, (Last visited: March 17, 2003)
***Related Technology Policy Issues
***Aging Demographics, Home Care and Urban Telemedicine
Two important trends that may greatly affect the telehealth industry and raise key policy issues are rapid technology changes and the aging population of America. However, predicting the future of the telehealth industry and the technical standards that will underpin "next generation" technology is like predicting the lottery. At most, we can describe some important emerging trends in the telehealth industry over the short term and suggest some related policy issues for the future.
Over the past five years, significant changes in the telehealth industry have been tied to rapid
technology advances and the convergence of the communications, media and computer industries. What has been even more dramatic is the exponentially expanding global reach of the Internet, which grew out of a community of U.S. academic and military developers to reach a world wide global audience in just a few years. Technology trends that will likely influence the near future of the telehealth industry and dictate the need for technical standards and guidelines are:
*** Next generation Internet;
*** The digitization of information; and
*** The migration toward wireless communications. Next Generation Internet
As consumers and businesses find more ways to use the Internet in their homes and businesses, the next generation Internet will enable these tasks to be accomplished faster, more securely and reliably than on our present system. Part of the anticipated next generation Internet, Internet2 is a joint venture by academia, the federal government and industry. This group is using a new high-speed backbone network with a core sub-network consisting of a 2.4 Gbps, 13,000-mile research network to test Internet applications such as Internet Protocol (IP) multicasting, differentiated service levels and advanced security. It will also allow researchers to test and resolve problems such as bandwidth constraints, quality and security issues.
DigitizationSimilar to the next generation Internet, the digital revolution is already upon us. Digitized data, voice, still images and motion-video can be mixed, matched, melded and sent over myriad types of conduits. Advances in digital and compression technology enable vast amounts of information to be stored onto smaller and smaller chips. Applications of this technology include the creation of digital medical libraries and medical databases, as well as the potential to widely adopt Electronic Medical Record Systems and Smart Cards that can hold medical information on a card the size of a credit card. Smart cards are already in use to a limited degree here in the U.S. and more widely overseas. Currently, however, there are no technical standards that can help to easily integrate telemedicine clinical data onto these systems and cards.
The use of wireless telemetry in hospital settings is already standard practice as discussed in the Chapter on Safety and Standards. (Examples of medical telemetry equipment include heart, blood pressure and respiration monitors.) In addition, Emergency Medical Services companies are or will be important users of telemetry and other wireless technology. Companies already use wireless telemetry or more advanced wireless technology such as wireless interactive video on emergency vehicles and to communicate with emergency physicians. It enables a paramedic to confer with an emergency physician for an early assessment, well before the patient's arrival at the hospital. Telemedicine equipment can be as simple as a laptop computer with desktop video conferencing capabilities that provide simultaneous two-way video, two-way voice, vital signs, cardiac and other data to a trauma center. Wireless technology is also useful in an emergency care hospital because emergency physicians, consulting a hand-held wireless device, do not have to leave the patient's side while researching unfamiliar symptoms.
Other wireless technology applications in telemedicine and telehealth will emerge as people adopt wireless applications in their every day lives. For example, the average consumer will be able to carry a mobile library of health information and diagnostics contained in a pocket-sized, handheld wireless computer. With such a wireless palm computer, the practitioner can send patient medical information from the hand held device to another wireless device next door or around the world or to a main data center in the hospital for storage.
Related Technology Policy Issues Policy Lags Technology
Policy makers have not been able to anticipate the changes brought about by the rapid technological advances, revolutionizing the health care industry. In just the past five years, discoveries related to DNA sequencing, the Human Genome Project, cloning and other scientific breakthroughs have raised questions about ethics, privacy and security. These types of discoveries combined with the exponential growth and use of the Internet have created a "policy lag" whereby policy is developed and implemented many months or even years after technology has changed lives, businesses and health care delivery. In the past, the development of regulatory policy, technical standards and protocols could be created over a number of years but not now. Internet time relates not only to businesses that must adjust to rapid industry changes but also to industry regulators.
Federal health privacy laws such as the Health Portability and Administrative Act (HIPAA) were conceived a few years before anyone could anticipate the dramatic growth and global reach of the Internet or the convergence of cable, digital, telephony and video technologies. HIPAA rules did not anticipate health practitioners, who could send multiple or a billion copies of a patient record in both text and video clips over the Internet in the form of email. Consequently, HIPAA policy and rules may have to be retrofitted to the current technology landscape and its future possibilities. For example, HIPAA proposed rules do not cover many health-related Web sites. The Next Generation Internet will raise other important privacy and security issues as health care administration and services migrate toward Internet and wireless technologies.
Technical Standards and Guidelines
With an increase in the use of advanced wireless technologies, such as hand-held devices with video Internet capabilities, there will be a critical need for technical standards. Standards will help to ensure interoperability, interconnection reliability, quality and security of medical data, images and video transmitted over the airwaves.
Telemedicine providers are already finding it difficult to get their equipment to "talk" to one another even if both perform the same function. Older machines will not talk to newer versions of themselves; different brands will not interconnect. This is frustrating to the health practitioner, trying to provide services, and it is very expensive.
Spectrum Frequency Allocation
As the health care industry adopts more sophisticated technology, requiring more bandwidth, the bandwidth size, location and status of spectrum frequency that the Federal Communications Commission allocates for medical purposes will likely become a key policy issue for the telehealth industry.
For example, streaming video requires a much larger bandwidth to convey natural movement than bandwidth required for wireless monitoring of vital statistics. An on-going dialogue about the "primary or secondary use" of designated or shared spectrum may be required between the Federal Communications Commission and health related organizations, particularly as the use of telemetry and more advanced wireless telehealth applications is more widely used and moves from institutions to the home or to other health related venues.
Spectrum frequency allocation has also become a growing safety issue. For example, in March 1999, incidences of digital TV interference with wireless medical telemetry equipment occurred at two hospitals in Dallas. (Examples of medical telemetry equipment include heart, blood pressure and respiration monitors.) When new digital TV services were piloted, medical telemetry equipment in these two hospitals did not work. Incidences like these highlight the dangers of electromagnetic interference with the operation of critical medical equipment and underline the need for appropriate spectrum allocation and designation.
In June 2000, the FCC allocated new spectrum and established rules for a Wireless Medical Telemetry Service (WMTS) that allows telemetry equipment to operate on an interference-protected basis. The FCC based its decision on formal comments from a number of organizations including the Food and Drug Administration and the American Hospital Association's Medical Telemetry Task Force, which provided specific recommendations for spectrum allocation. OAT also filed comments with the FCC, supporting the AHA recommendations and submitted additional comments concerning the possible future uses and spectrum needs of telemedicine and telehealth applications.
With the Internet, digitization and wireless technologies, the concept of either domestic or international borders will become blurred. As this trend accelerates, cross-state jurisdiction and enforcement issues will become harder to disentangle. Blurring borders may also expand the purview of general practitioners. For instance, if a Physician Assistant or Nurse Practitioner works with a primary care physician or specialist on an ongoing basis and slowly assumes more of the physician's basic duties, then a gradual change in practice will naturally occur over time. How will states decide to license these practitioners? Will they receive special credentials?
A discussion of how demographic trends will affect the health industry is not within the scope of this Report but it is hard to ignore the effect the aging of the Baby Boomer generation will have on the health care and telehealth industry. An aging population with a longer life expectancy may mean a larger population of "fragile" elderly, the chronically ill and those requiring rehabilitation.
Given this demographic trend, recent studies and workshops14 show that home care medical devices were the fastest growing segment of the medical device industry throughout the 1990s. A report from the Workshop on Home Care Technologies for the 21st Century suggests: "Consumer demand for home health and home health care is not new. When patients have a choice, and if they have a reasonably stable and caring home environment, they choose to go home, almost without exception. If they have a severe, chronic, difficult condition it is difficult to permit them to go home, unless the home is fitted with the appropriate technology and care giver. We have the opportunity today to make this choice possible by developing technology that is easy to use, suitable for the patients' particular needs and allows access to trained, off-site professionals who can work with the patient on educational/problem areas of concern."15 Given the movement toward home health care, tele-homecare will most likely play an increasingly larger and more important role in the home health care industry.
Home care in the future may rely on new applications for wireless technology. Tele-homecare can be defined as providing monitoring (telemetry) and home health care services at a distance, using advanced telecommunications and information technology. Aside from videophones, wireless biosensors and feedback loops data can be used to monitor patients who can not get out of bed. OAT grantees have found that tele-home health care has been largely successful, and can allow greater access to care, particularly in rural settings where a nurse may have to travel 200 miles one-way to see a patient at home face-to-face. With tele-homecare, a rural nurse can "visit" six patients in one day, using interactive video instead of traveling 200-300 miles to visit one patient face-to-face for 20 minutes.
Providing tele-home care to the elderly or disabled populations, using telemedicine raises important policy questions about health care access and the reimbursement of telemedicine services for both rural and urban patients. It can be argued that urban patients who are very elderly, chronically ill, poor or disabled may be as isolated and have as much difficulty getting access to needed health services as those patients, living in rural areas. Most of these urban patients cannot drive to their local clinics and many require assistance getting from point A to point B. Traveling a mile for such an urban patient may be as difficult as the two hundred-mile or more drive, that a mobile rural patient must make to see a specialist.
Reimbursement for both urban and rural patients may be a cost effective policy decision for tele-homecare. Studies show tele-homecare can save money by decreasing unnecessary hospital and emergency room admittances. Around-the-clock monitoring and nurse availability over videoconferencing has helped patients better self-diagnose and maintain drug therapies.
This policy issue may be resolved at the third party payer level, if cost savings are sufficiently great enough to attract the attention of this group.
Privacy, Confidentiality, and E-health
2. Internet and the Right to Privacy in E-health Pacific West Law Group
Another major area of interest in e-health legal issues is that of privacy. There is no greater area of potential liability for e-health companies than the unauthorized disclosure of confidential medical information about an individual. Most states have some kind of legislation protecting the confidentiality of medical information of its citizens. Federal law has also extended similar protections through the Health Care Financing Administration and its Medicare and Medicaid programs. Stringent new confidentiality requirements are now being developed as a part of the regulations under the federal Health Insurance Portability and Accountability Act of 1996 to protect individually identifiable health information from unauthorized disclosure.
***Next Steps Overview
Privacy, security and confidentiality concerns are not unique to telemedicine. Industries such as banking, credit card and health care are particularly concerned about personally identifiable information and the possible consequences that could arise should sensitive information be made public. Advances in technology have brought great benefits as well as drawbacks in this area. Many view loss of privacy as part of living in the 21st Century. As Scott McNealy, Chairman and CEO of Sun Microsystems has succinctly put it: "You have no privacy-so get over it!" Fortunately, Congress, a number of state governments and privacy advocates provide a balance to this point of view.
A non-official "working definition"8 of these concepts is that Privacy is an individual's claim to control the use and disclosure of personal information. This claim is backed by the societal value representing that claim. Confidentiality is a status accorded to information that indicates it is sensitive for stated reasons and therefore must be protected and access to it controlled. Security are the safeguards (administrative, technical, or physical) in an information system that protect it and its contents against unauthorized disclosure, and limit access to authorized users in accordance with an established policy.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) not only affects employees' health insurance portability but under the Administrative Simplification (AS) provisions also mandates the development of far reaching national standards for electronic health transactions. These standards include electronic transaction standards for electronic exchange of health information for administrative purposes; standards for the privacy of individually identifiable health information; a national provider identifier; an employer identifier; and secure electronic signatures, among others.
According to the Act, the Secretary of DHHS must develop final regulations relating to privacy standards by February 2000, if Congress has not acted by August 1999. In 1997, the Secretary together with the National Committee on Vital and Health Statistics (NCVHS), which serves as the statutory public advisory body to the Secretary, sent preliminary recommendations to Congress. In the absence of Congressional action by the mandated deadline, DHHS published a notice of proposed rulemaking in November 1999. Final HIPAA privacy rules were published December 28, 2000 and an DHHS fact sheet on these rules can be found in Appendix 7. The complete text and the summary can be found at: http://aspe.hhs.gov/admnsimp.
HIPAA privacy rules cover health plans (e.g., insurers, managed care organizations, federal health programs), health clearinghouses (which unify data in standardized formats) and health care providers, who use who engage, directly or through contractual arrangements, in HIPAA standard electronic transactions. Eligible individually identifiable health information can be in electronic, paper or oral format. Thus, the general principles for the use and disclosure of personally identifiable health information are applicable regardless of the form the information is kept in, the methods of transmission, the time sequence of its creation and use, or the way it is communicated. Consequently, the proposed standards for the privacy of individually identifiable health information may greatly affect how the healthcare industry as a whole and the telemedicine industry in particular protects privacy in the future.
Potentially one of the most challenging issues for telemedicine practitioners will be DHHS' proposal for federal law to preempt state law only when state privacy law is less stringent. If state law is in conflict with federal regulatory requirements, the rules providing more stringent privacy protections should prevail. If many states have more stringent privacy laws, they would all predominate and telemedicine practitioners could be faced with a patchwork of state privacy standards. For example, should telemedicine specialists at a hospital in state A, who confer with patients in states B, C, D and E, determine which state law of the five states is the most stringent for privacy and comply with that state law?
All states have laws governing the use and disclosure of health information; however, there are wide discrepancies in protection, complexity and coverage among them. Moreover, there is typically no one statute governing health data within a state. The Health Privacy Project of the Institute for Health Care Research and Policy at Georgetown University has compiled a comprehensive 50-state survey of health privacy statutes. A summary of findings is found at the Health Privacy Project Web site at: http://www.healthprivacy.org/resources/statereports/exsum.html. At this time, it is too early to predict the impact HIPAA privacy requirements will have on the health industry at large or the telehealth industry in particular. On one hand, ensuring and maintaining patient privacy and security measures are good business practice. These practices could provide greater reassurance to those reluctant to participate in telemedicine for privacy or other reasons. On the other hand, specific requirements that do not reflect telemedicine common practices may create problems. Whether HIPAA requirements prove to be too burdensome for telemedicine practitioners or whether HIPAA will create a "chilling" effect on the industry remains to be seen.
OAT and the Assistant Secretary's Office of Planning and Evaluation have recently funded a study and a conference entitled Privacy, HIPAA and Telemedicine that will be completed in Spring 2001. The purpose of the study is to identify privacy issues unique to telemedicine and to determine how HIPAA may affect telemedicine practitioners and patients. The study will draw upon the experience of OAT's grantees, who include over 60 telemedicine networks and over 400 sites.
As we discuss in the Chapter on Emerging Trends and Policy Issues, technology changes in the industry may call for retrofitting HIPAA rules. HIPAA rules do not necessarily cover all consumer-oriented Internet Web sites that collect, store and maintain personally identifiable consumer information. Thus, this privacy measure does not cover an important telemedicine and consumer arena. A further discussion of this subject is highlighted below.
While a detailed discussion about consumer health privacy online is not within the scope of this report, it is important to note some recent findings. Over the past few years, consumer concerns about privacy on the Internet have escalated. According to a new Gallup poll commissioned by the MedicAlert Foundation, "almost 90% of participants said that, in general, the confidentiality of their personal health information was important, and almost 85% said the were "concerned" that this information could be given to others without their consent."9 The public's concern about privacy online may be justified, according to several recent reports and surveys.
***Global-Healthrax, which sells health products online, inadvertently revealed names, home phone numbers, bank account and credit card information of thousands of customers on its Web site.
***Kaiser Permanente mistakenly sent responses to members' e-mail to the wrong recipients. The email messages, some of which contained sensitive information, affected 858 members who use Kaiser's on-line services.
***Finally, thousands of patient records were accidentally made available to the public on the University of Michigan Medical center's Web site.
For example, Georgetown University recently released a report, called the Health Privacy Project (http://ehealth.chcf.org/), about the practice of privacy protocols on health related web sites. The five major findings are:
*** Consumers are using health Web sites to better manage their health, but their personal information may not be adequately protected.
***Visitors to health Web sites are not anonymous, even if they think they are.
***Health Web sites recognize consumers' concern about the privacy of their personal health information and have made efforts to establish privacy policies; however, the policies fall short of truly safeguarding consumers.
***There is inconsistency between the privacy policies and the actual practices of health Web sites.
***Health Web sites with privacy policies,that disclaim liability for the actions of third parties on the site, negate those very policies.
Other notable reports that discuss consumer privacy and the Internet include those released by the FTC (see below) and a series of publications, included in a special edition of Health Affairs, Vol. 19, No. 6. According to one, entitled Virtually Exposed: Privacy and E-Health, "a recent study of 21 leading health related Web sites found that the polices and practices of many fell short of consumers' expectations for privacy." The publication also pointed out news stories, highlighting the lax security for information shared and maintained online, as shown in Box 7. Consumers are using health Web sites to better manage their health, but their personal information may not be adequately protected.
Both the states and Congress have also responded to consumer privacy concerns by introducing a large number of bills that attempt to protect the privacy of personal information collected from the Internet. For example, Congress introduced and passed the Children's Online Privacy Protection Act of 1998. This law requires the FTC to develop regulations, protecting the privacy of personal information collected from and about children on the Internet and to provide greater parental control over the collection and use of that information. Recently, Congress introduced the Health Information Privacy Act (H.R.1941); the Medical Information Protection and Research Enhancement Act of 1999 (H.R.2470); the Consumer Privacy Protection Act (SB 2606 IS); the Consumer Internet Privacy Protection Act of 1999, (H.R.313 IH); and the Consumer Internet Privacy Enhancement Act, among other bills that seek to protect the privacy of consumers who use the Internet.
As noted in the previous Chapter, the FDA, Department of Justice and state governments all have roles in online regulation and enforcement but the FTC has emerged as a key online consumer protection regulator, overseeing privacy protection and deceptive trade practices on commercial Web sites. The FTC has published a number of reports on online consumer protection, including Protecting Consumers Online: A Federal Trade Commission Report on the First Five Years of Its Internet Law Enforcement Program, 1999. It also recently submitted a Report to Congress, entitled Privacy Online: Fair Information Practices in the Electronic Marketplace, May 2000 (http://www.ftc.gov/os/2000/05/index.htm#22). Among other things, this Report establishes the FTC's authority to regulate personal data collected online, based on Section 5 of the Federal Trade Commission Act and the Children's Online Privacy Protection Act. However, the FTC still lacks authority to require Web companies to adopt standard information practices such as its Privacy Principles. These four widely accepted information privacy principles are outlined below:
*** Notice: Provide consumers clear and conspicuous notice of information practices;
*** Choice: Offer consumers choices as to how their personal identifying information is used;
*** Access: Give consumers reasonable access to the information the Web site has collected about them;
*** Security: Take reasonable steps to protect the security of the information collected from consumers.
While the FTC continues to strongly encourage industry self-regulation, its 2000 Report Survey demonstrates that self-regulation alone has not been sufficient. According to the Report, only 20% of the busiest Web sites comply with FTC Information Privacy Principles and only about 41% of all Web sites comply with at least two principles.
In the past, the FTC has been reluctant to recommend legislative remedies but in the 2000 Report, the FTC offers legislative recommendations to Congress that would set a basic level of privacy protection for all visitors to consumer-oriented commercial Web sites. The legislation would "require all consumer oriented commercial Web sites to the extent already covered by the Children's Online Privacy Protection Act of 1998 (COPPA), to implement the four widely-accepted fair information practice principles, in accordance with more specific regulations to follow."10
*** OAT together with the Office for the Assistant Secretary of Planning and Evaluation have funded a research paper, Privacy, HIPAA and Telemedicine, as well as a conference on the same subject. OAT and OASPE anticipate that the final paper and conference will be completed by summer 2001 and the results made available to the public both in print and on OAT's Web site, shortly thereafter.
8Willis Ware, Lessons for the Future: Dimensions of Medical Record Keeping, in Health Records: Social Needs and Personal Privacy 43 (Task Force on Privacy, U.S. Department of Health and Human Services (1993)).
9California Healthcare Foundation, Online News (http://ehealth.chcf.org).
Medical Records and E-Health
The E-Signature Law will Facilitate E-Health Transactions, but will not Substitute Strong Risk Management Techniques
September 14, 2000
The health care industry, like other sectors of the economy, is till processing the recent enactment of the "Millennium Digital Commence Act" known to the public as the electronic signature law. The Act creates an opportunity for the progression of e-commerce and e-health by encouraging seemless electronic interaction between parties from initial negotiation or interaction through closing or discharge.
Electronic signatures will be a facilitating device for health care companies’ business-to-business and business to consumer transactions. However, the extent of the legal comfort zone will, to some extent, await the maturation and dissemination of encryption technology, biometrics and other electronic security technologies, as the key element to the development of electronic transactions continues to be the trust between the parties.
The electronic signature law provides that:
If a statute, regulation or other rule of law requires that a contract or other record relating to a transaction in or affecting interstate or foreign commerce be retained, that requirement is met by retaining an electronic record of the information in the contract or other record...
Of particular interest is the scarcity of a requirement in the statute concerning security and authentication requirements for such records. The statute requires only that the electronic record accurately reflect the information set forth and that it remain "accessible to all persons who are entitled to access by statute, regulation or rule of law..." Questions of accessibility, maintenance and reproduction of electronic records are likely to be less taxing than questions of which party will assume the risks associated with verification and authentication of electronic signatures. As technology continues to develop and as the health care industry further embraces the opportunities of e-health, the issue will increasingly become whether or not the software provider, ASP or other business partners, rather than your organization, will assume such risks.
Health care entities’ use of electronic records will be additionally guided by Medicare conditions of participation which, while permitting the use of computerized records and authentication, do require the hospital to have a system for record identification and maintenance which ensures their integrity and protects their security. In addition state mandated safeguards and guidance will vary.
Thus, from a business planning and legal risk management perspective, the electronic signature law will be facilitative in those jurisdictions where traditional licensure statutes have not yet been "scrubbed" for the digital world. Multistate companies will still need to comply with a variety of state statutory requirements as to authentication and record integrity. However, those standards generally require only that the provider develop policies and procedures to address natural exposures and should be regarded as consistent with best practices and sound corporate risk management. Moving at "internet speed" should be a favorable product of your e-health transactions not a replacement of your organization’s best corporate practices.
Richard H. Vincent and R. Michael Barry are managing partner and associate, respectively, at the Atlanta office of Epstein Becker & Green, P.C. The office reflects EBG's national focus on business transactions, regulatory advice and corporate litigation with particular emphasis on health care and employment law. Please feel free to contact Richard H. Vincent or R. Michael Barry at 404/812-5680 in the firm's Atlanta office if you would like additional information regarding e-Health Law issues, or have any questions or comments. Mr. Vincent's e-mail adress is email@example.com and Mr. Barry's e-mail address is firstname.lastname@example.org.
The Emancipation of the Electronic Medical Record The Overlooked Feature of the E-Signature Law
By: Mark Lutes, Esq.
Washington, D.C. Office, ugust 7, 2000
The healthcare industry, like other sectors of the economy, is still processing the recent enactment of the "Millennium Digital Commerce Act" known to the public as the electronic signature law. Electronic signature
usage promises, as technology evolves, to be a facilitating device for health
care companies’ business-to-business and business to consumer transactions.
However, the extent of the legal comfort zone will, to some extent, await the
maturation and dissemination of encryption technology, biometrics and other
electronic security technologies.
One application of the Act need not await such maturation at
least from the legal perspective. That application is the law’s effect on healthcare
State licensing statutes have frequently cast a pall over electronic
medical record development. Hospital and other facility licensure statutes and
regulations often require the maintenance of "written" records. Other
regulations go further to specify that records be maintained in ink or be typewritten.
Still others require specific orders to be signed and sometimes that the signature
be in ink.
Along comes the electronic signature law and its clears the air.
It provides that:
If a statute, regulation or other rule of law requires that a contract or other record relating to a transaction in or affecting interstate or foreign commerce be retained, that requirement is met by retaining an electronic record of the information in the contract or other record …
The legislative history of this provision is relatively sparse. For example, the Senate Report refers only to the statute’s affirmation of the legal effect of contracts formed by electronic interaction.
Also of interest is the scarcity of a requirement in the statute concerning security and authentication requirements for such records. The statute requires only that the electronic record accurately reflect the information set forth and that it remain "accessible to all persons who are entitled to access by statute, regulation or rule of law…"
In the health care environment, hospitals and other health care facilities use of electronic records will be additionally guided by Medicare conditions of participation which, while permitting the use of computerized records and authentication, do require the hospital to have a system for record identification and maintenance which ensures their integrity and protects their security. Joint Commission standards require a system of attestation to singular use of the code for the computer key used to authenticate the record. Some states, like California, require facilities and clinics to have a variety of system safeguards including backup storage systems, imaging technology for reproducing signed documents and a mechanism to prevent the destruction of records.
Providers and payors who are neither effected by the Medicare
standards for facility participation nor by a state law baseline policy will experience comparable regulation under HIPAA’s security standards at least with respect to those records that contain individually identifiable health information (as a practical matter most records).
Thus, from a business planning and legal risk management perspective, the electronic signature law will be facilitative in those jurisdictions where traditional licensure statutes have not yet been "scrubbed" for the digital world. Multistate companies will still need to comply with a variety of state statutory requirements as to authentication and record integrity. However, those standards generally require only that the provider develop policies and procedures to address natural exposures and should be regarded as consistent with best practices and sound corporate risk management.
Licensing and E-health
Interstate Practice of Medicine and E-Health
Pacific West Law Group http://www.pacificwestlaw.com/ehealth/ehealthlaw.htm
In the area of e-health, legal concerns have been raised regarding the practice of medicine through electronic transmissions such as the Internet over state lines. Although the conventional wisdom is that physicians may not practice medicine in states where they are not licensed, the law has begun to evolve in the direction of allowing the interstate practice of medicine where the Internet allows the practice to be a clear benefit to the patient in the form of improved health care. For example, the use of electronic imaging to transmit x-rays and other diagnostic scans for examination by radiologists across state lines have been the subject of new legislation to permit this developing form of medical practice.
Other examples include new state legislation to permit nurses employed by health plans to operate 24 hour advice lines across state lines, and new legislation to make it easier to permit pharmacies to operate across state lines over the Internet.
It appears that if the Internet can be used in a rational fashion to benefit patients, interstate licensing concerns have fallen by the wayside as legislatures operate to remove interstate licensing barriers.
***Next Steps Overview
Five years ago, interstate licensure issues were thought to be among the most critical barriers to telemedicine. Today, the problem has been compounded by the growth and consumer use of the Internet. The Internet has also raised new legal issues that may grow to overshadow interstate licensure.
Since the Department of Commerce's 1997 Report to Congress on Telemedicine was published, the problem of multiple state licensure requirements for telemedicine providers has not improved and in some ways has worsened. Since then, more states have adopted restrictive laws requiring out-of-state telemedicine practitioners to obtain local state medical licenses.
Historically, states have had the authority to regulate activities affecting the health, safety and welfare of their citizens. Hence, health professionals in the United States are licensed at the state level. States define the process and procedures for granting a health professional license, renewing a license and regulating medical practice within the state. The Federal government does have the authority to establish national regulations such as those under Medicare that set specific eligibility requirements for reimbursement. However, there is a strong legal presumption against federal preemption of state licensure laws. Therefore, unless Congress acts to regulate telemedicine licensure, the states themselves must decide to harmonize their standards and laws. Tables 2 and 3 below illustrate generic and specific licensure models that could be used for multiple state health licenses.
TABLE 2: General Licensure Models Consulting Exceptions With a consulting exception, a physician who is unlicenced in a particular state can practice medicine in that state at the request of and in consultation with a referring physician. The scope of these exceptions varies from state to state. Most consultation exceptions prohibit the out-of-state physician from opening an office or receiving calls in the state. In most states, these exceptions were enacted before the advent of telemedicine and were not meant to apply to on-going regular telemedicine links. However, some states permit a specific number of consulting exceptions per year. Hawaii, Colorado and California allow significant consulting exceptions. Endorsement State boards can grant licenses to health professionals in other states with equivalent standards. Health professionals must apply for a license by endorsement from each state in which they seek to practice. States may require additional qualifications or documentation before endorsing a license issued by another state. Endorsement allows states to retain their traditional power to set and enforce standards that best meet the needs of the local population. However, complying with diverse state requirements and standards can be time consuming and expensive for a multi-state practitioner. Reciprocity A licensure system based on reciprocity would require the authorities of each state to negotiate and enter agreements to recognize licenses issued by the other state without a further review of individual credentials. These negotiations could be bilateral or multilateral. A license valid in one state would give privileges to practice in all other states with which the home state has agreements. Mutual Recognition Mutual recognition is a system in which the licensing authorities voluntarily enter into an agreement to legally accept the policies and processes (licensure) of a licensee's home state. Licensure based on mutual recognition is comprised of three components: a home state, a host state and a harmonization of standards for licensure and professional conduct. The health professional secures a license in his/her own home state and is not required to obtain additional licenses to practice in other states. The nurse licensure compact is based on this model. Registration Under a registration system, a health professional licensed in one state would inform the authorities of other states that s/he wished to practice part-time there. By registering, the health professional would agree to operate under the legal authority and jurisdiction of the other state. Health professionals would not be required to meet entrance requirements imposed upon those licensed in the host state but they would be held accountable for breaches in professional conduct in any state in which they are registered. California has the authority to draft this type of model. Limited Licensure Under a limited licensure system, a health professional would have to obtain a license from each state in which s/he practiced but would have the option of obtaining a limited license for the delivery of specific health services under particular circumstances. Thus, the system would limit the scope rather than the time period of practice. The health professional would be required to maintain a full and unrestricted license in at least one state. The Federation of State Medical Boards has proposed a variation of this model. National Licensure A national licensure system could be adopted on the state or national level. A license would be issued based on a universal standard for the practice of health care in the US. If administered at the national level, questions might be raised about state revenue loss, the legal authority of states and logistics about how data would be collected and processed. If administered at the state level, these questions might be alleviated. States would have to agree on a common set of standards and criteria ranging from qualifications to discipline. Federal Licensure Under a Federal licensure system health professionals would be issued one license, valid through the US, by the Federal government. Licensure would be based on Federally established standards related to qualifications and discipline and would preempt state licensure laws. Federal agencies would administer the system. However, given the difficulties associated with central administration and enforcement, the states might play a role in implementation.
Source: Department of Commerce, "Report to Congress on Telemedicine," 1997.
TABLE 3: Specific Licensure Models American College of Radiology (ACR) In 1994, the ACR adopted a" Standard for Teleradiology" and developed a Model Act based on this standard that is similar to the general endorsement model described above. American Medical Association (AMA) In 1994, the AMA adopted a policy that "states and their medical boards should require a full and unrestricted license for all physicians practicing telemedicine within a state." California Registration The State of California's law is a specific example of a registration model. In 1997, California passed laws that permits the Board of Medicine to create a registration program for telemedicine providers. College of American Pathologists (CAP) The CAP model is a variation of the endorsement model. This proposal requires physicians to have their licenses endorsed in each state from which they receive patient specimens or information. The CAP suggests that an abbreviated licensure process would be preferable to a license for limited practice. Federation of State Medical Boards(FSMB) The FSMB supports a special licensure for telemedicine, a variation on the general limited licensure model. In 1995, FSMB proposed an "Act to Regulate the Practice of Medicine Across State Lines." Under this Act, a physician would be required to obtain a special license issued by the state medical board. Several states have adopted variations on this model including Alabama, Tennessee and Texas. National Council of State Boards of Nursing (NCSBN) The National Council's model is the most far reaching of any model and is based on the general mutual recognition model. In November 1998, the National Council adopted language for an Interstate Nurse Licensure Compact. This compact creates a unified standard for nurses' licenses. Nurses will be able practice telemedicine in whichever states adopt the compact. Licenses will be fully recognized by the host and home state by mutual recognition. To date, Arkansas, Delaware, Iowa, Maine, Maryland, Miss, Nebraska, NC, SD, Texas, Utah and Wisconsin have passed this compact into law.
Sources: Commerce Department, "Report to Congress on Telemedicine," 1997; Western Governors Association
Under this compact, the head of the nursing licensing board willadminister the Compact for his/her state. Among other things, this compact states that: "license to practice registered nursing issued by a home state to a resident in that state will be recognized by each party state as authorizing a multi-state licensure privilege to practice as a registered nurse in such party state." This compact also applies to a license to practice licensed practical/ vocational nursing.
To coordinate these multi-state licenses, all party states "shall participate in a cooperative effort to create a coordinated data base of all licensed nurses and licensed practical/ vocational nurses." Including information on a nurse's licensure and disciplinary history.
In early 1997 only 11 states had telemedicine licensure laws. Today, about 26 states have introduced licensure laws pertaining specifically to telemedicine that may make it more difficult for physicians to practice telemedicine across state lines. Appendix 2 lists these states. Making it easier for nurses to practice across state lines, the National Council of State Boards of Nursing
(NCSBN) developed a licensure model based on mutual recognition called the Interstate Nurse Licensure Compact. As described in Box 2, NCSBN promotes the introduction of legislation and the adoption of state laws to allow nurses to practice across state borders without being licensed outside their home states.
Arkansas, Delaware, Iowa, Maine, Maryland, Mississippi, Nebraska, North Carolina, South Dakota, Texas, Utah and Wisconsin
Currently, 12 states have adopted the Nurse Licensure Compact as listed in Box 3. Other organizations, such as the National Association of Pediatric Nurse Associates, and Practitioners, and the Association of Women's Health, Obstetric and Neonatal Nurses, believe that alternative models like the national licensure model, as described in Table 2 and in their letter in Appendix 3 may be a better solution.
Consumers with access to the World Wide Web can peruse volumes of health information, join chat groups, purchase pharmaceuticals in privacy and consult a health care practitioner for a fee. But together with these benefits, the Internet has added new twists to old licensure problems and has raised other legal issues. For example, given the nature of the Web, it may be difficult for a consumer or state government to determine whether or not particular Web sites comply with states' laws pertaining to a physician's or other health practitioner's interstate practice. Theoretically, online health practitioners, who do not provide specific medical advice or diagnosis, would probably not be seen as practicing medicine across state lines. Realistically however, these consultations can fall into large gray areas.
Perhaps the larger legal issue for many states may be their ability to enforce their own state health laws. For example, if a consumer, located in state A, sues an on-line practitioner, based in state B, who has jurisdiction in this case? Does the jurisdiction change if the interactive consultation was accomplished via the Web, over the telephone, via email or a two-way teleconferencing unit? What happens if the Web site was created and staffed outside the United States? What recourse would the consumer have if the Web site was immediately taken down but reconfigured under a different address the next day?
These legal questions apply not only to Web based companies but also to companies that provide health care consultations using any type of technology across state boarders. For example, many health insurance companies now give their clients the option to consult with a nurse over the telephone before seeking face-to-face medical consultation. Large health insurance companies with a national base will often subcontract to a company with a central office staffed with nurses, who field incoming nationwide calls. Do these nurses need to be licensed in every state in order to answer these calls?
A recent DHHS report, Wired for Health and Well-Being, (http://www.scipich.org) states that "the extent and nature of liability associated with IHC (Interactive Health Communication) applications are unclear. Providing medical advice through IHC applications, including Web sites, increases potential liability for developers. To what extent the developers, sponsors, content providers, or others involved in the design and implementation of the application will be liable for damages is unknown. In the absence of precedents in this area, future legal action and case law may provide some clarity on these issues." (Wired for Health and Well-Being, DHHS, Office of Public Health and Science, April 1999)
Finally, whether Web developers are state certified or not, the issue of illegal drugs sold over the Internet or legal drugs sold without an initial patient examination by a physician has created a growing safety and legal challenge for both state and federal regulators, as discussed in the next chapter.
Another dilemma that has not been resolved is whether or not health care practitioners providing telehealth services should be certified in this area. Earlier this year, the Joint Working Group on Telemedicine (JWGT) developed a draft discussion paper (See Appendix 4), exploring the advantages and disadvantages of certification. According to the paper, there is confusion about the meaning of the term. Credentialing, certification, privileging and licensing are often used interchangeably to describe the validation of practitioners' competencies in telehealth. National professional and provider organizations and government agencies are increasingly queried about whether there is a need for additional and/or official validation of practitioners' competency to engage in telehealth. And it is unclear whether the questions about validation relate either solely to the equipment used or to the clinical care delivered. Additional complexity surrounds the relationship of the validation of individuals versus organizations.
The JWGT hopes to compile comments about the draft paper from interested parties and provide a summary of its findings.
Although little has been resolved about individual accreditation, there has been change at the institutional level. In the fall of 2000, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), an independent, not-for-profit organization, adopted new credentialing standards for hospitals using telemedicine. The full text of these new standards, which become effective January 1, 2001, can be found at http://www.jcaho.org/standard/medicalstaff_rev.html#Telemedicine. JCAHO evaluates and accredits nearly 20,000 health care organizations and programs in the United States. Its accreditation is recognized nationwide as a symbol of quality that indicates that an organization meets certain performance standards. To earn and maintain accreditation, an organization must undergo an on site survey by a JCAHO survey team at least every three years.4 The new standards amend medical staff standards within the accreditation manual for hospitals. According to the manual:
"If a telemedicine practitioner prescribes or renders a diagnosis, or otherwise provides clinical treatment to a patient, the telemedicine practitioner is credentialed and privileged by the organization receiving the telemedicine service. An organization may use credentialing information from another Joint Commission accredited facility, so long as the decision to delineate privileges is made at the facility that is receiving the telemedicine service."
*** The Joint Working Group on Telemedicine will work with various state governmental and professional groups to assess the feasibility of developing common licensure application forms, similar to the common college application form, accepted at a number of universities. Common applications will reduce time and costs associated with completing numerous different applications that vary in state requirements and paperwork. States, in turn, can more easily develop a comprehensive database on practitioners and track them across state borders. Footnotes
4Information about the Joint Commission was taken from their Web site at http://www.jcaho.org.
E-health and Credentialing
However, e-health companies that utilize health care providers and seek to provide medical advice to specific individuals face daunting problems over liability issues. E-health companies desire to provide quality professional services on-line and are generally obligated by law to insure that their providers are adequately qualified and credentialed. Although the credentialing process may be contracted out to third parties, the e-health company must insure that the third party is conducting their investigation in a reasonable and thorough manner, and that the third party is insured and has the financial ability to defend and indemnify the e-health company for the third party’s negligence.
Further guidance by the e-health company as to specific policies and procedures for providers to follow may expose the company to liability for the malpractice of the provider since the doctrine of vicarious liability or principal-agent law could be used to transform an e-health company’s guidelines into a legal duty of care to be met.
Needless to say, e-health companies should consider purchasing insurance to protect them and their officers and directors from any liability. Insurance products are now coming on the market to protect e-health companies from such liability.
Payment and ehealth
One of the greatest stumbling blocks to the expansion of the telehealth industry has been lack of reimbursement for telemedicine and telehealth services. Advances in telemedicine technology have made it easy to deliver health care services over a distance but few public or private payers will pay telemedicine costs. Until recently, Medicare has not had an explicit policy to pay for telemedicine services. Historically, Medicare reimbursed some services that did not traditionally require face-to-face contact between a patient and practitioner. For example, it covered EKG or EEG interpretation, teleradiology and telepathology in most of the nation, depending on individual Medicare carrier policies.
However, the Balanced Budget Act of 1997 (BBA) brought about a significant change in Medicare telemedicine reimbursement policy. As of Jan. 1, 1999, Congress required the Health Care Financing Administration (HCFA) to pay for telemedicine consultation services under the BBA. Some important reimbursement eligibility requirements are outlined in Table 1 below.
TABLE 1: HCFA Telemedicine Reimbursement Requirements Under the Medicare, Medicaid and SCHIP Benefits and Improvement Protection Act of 2000 Scope Eligibility Requirements Geographic Scope Only patients located in Rural Health Professional Shortage Areas (HPSAs), counties in Non-MSAs and in approved Federal demonstration projects are eligible for telemedicine reimbursement. A list of shortage areas can be found at http://www.access.gpo.gov. Eligible CPT Codes Eligible Current Procedural Terminology (CPT) codes include professional consultations, office visits, and office psychiatry services (codes 99241-99275; 99201-99215;90804-90809) and any other additional services specified by the DHHS Secretary. Eligible Presenting Practitioner The new law eliminates the requirement to have a telehealth presenter present a patient at a consultation unless it is medically necessary (as determined by the physician or practitioner at the distant site) Fee-Sharing The new law eliminates the fee sharing requirement between a consultant and referring physician. Eligible Technology3 The new Act provides for reimbursement for store and forward technology in demonstration projects in Alaska and Hawaii but no other setting. HCFA's payment policy was developed to replicate a standard consultation as closely as possible. Under Medicare, a separate payment for a consultation requires a face to face examination of the patient. This requirement is consistent with the American Medical Association's description of a consultation. To that end, Medicare's teleconsultation rule requires a certain level of interaction between the patient and consulting practitioner because it offers the best substitute for a "face-to-face" consultation. Regardless of the technology, the patient must be present during the consultation. Medicare does not currently make separate payment for the review and interpretation of a previous examination, photos or records. Home Health Care The new Act clarifies that home health agencies "may adopt telehealth technology that it believes promotes efficiencies or improves quality of care, however, these technologies will not be specifically recognized or reimbursed under the home health benefit. Telehealth encounters do not meet the definition of a Medicare covered home health visit. But this does not preclude a home health agency from spending prospective payment dollars to furnish services outside of the Medicare home health benefit (i.e., for telehealth services to home health beneficiaries). If a physician intends that telehealth serivces be furnished while a patient is under a home ehalth program of care, this should be recorded in addition to the Medicare covered home health services to be furnished." Medicare Reimbursement-The First Two Years
Over the first two years of the Medicare telemedicine reimbursement rule, many telehealth practitioners have found both the BBA mandates and HCFA's interpretation of the BBA too narrow for most practical purposes. On September 30, 2000, after almost two years of telemedicine reimbursement, Medicare has reimbursed a total of $20,000 for 301 teleconsultation claims.
Four major issues may have greatly limited the number of reimbursable telemedicine consultations:
*** Health Professional Shortage Area Limitations. Only patients in Health Professional Shortage Areas (HPSAs) were eligible for reimbursement under the BBA. This restriction greatly narrows the number of people, who might benefit from telemedicine, and disregards the needs of many rural patients, who may have access to a nurse or general practitioner, but not to specialists such as cardiologists, psychologists, dermatologists, etc.
***Fee-sharing requirement. Consulting physicians found fee-sharing problematic because they receive only 75 percent of normal pay for their services. Moreover, HFCA reports consultant payment to the IRS at 100 percent. Other problems with fee-sharing included accounting and fee tracking. Most rural practitioners are not equipped to track split fees. Finally, perhaps the most important ramification of the fee-sharing requirement is that, to be paid, the eligible presenter must either be the referring physician or an employee of the referring physician. In many cases, the presenter is an employee of the local hospital or clinic.
*** Eligible presenters. In many (if not most) places rural clinics are staffed only by registered nurses (RNs), licensed practical nurses (LPNs) or by health technicians, who were all ineligible presenters under the Act. In a survey of 20 telehealth networks representing 4,761 telehealth encounters between Jan. 1, 1999 and June 30, 1999, the University of Missouri found that: LPNs and RNs make up the majority of patient presenters in almost all telehealth networks, but they are not eligible presenters. 171 or 3.6% of all encounters involved a patient interaction with either an occupational, physical, speech therapist or clinical psychologist. Only 7% of referring practitioners or employees of the referring practitioner acted as patient presenters in consultations. This suggests that if all of the reported 4,761 telehealth activities were Medicare, less than 7 percent of all cases would meet HCFA's eligible presenter criteria.
***Eligible Current Procedural Terminology Codes. Only a handful of CPT codes were eligible for HCFA telemedicine reimbursement under BBA. This limitation greatly restricted the types of services for which practitioners could be reimbursed. Many services that telemedicine providers already offer were not included in these codes. Legislation
The House and Senate introduced nine bills with telehealth provisions in the 106th Session to address the BBA's telemedicine reimbursement limitations and to allow more Medicare coverage for telemedicine services. At the end of December 2000, Congress passed the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 ("the Act"), which is effective October 1,2001.
Among other things, Section 223 of the Act, eliminates the presenter and fee-sharing requirements, expands eligible locations to include HPSAs and counties not included in a Metropolitan Statistical Area, expands the number of CPT codes that are eligible for Medicare reimbursement and provides full reimbursement to a specialist for services rendered in a teleconsultation. Section 503 addresses the use of telehealth in the delivery of home health services. (See Appendix 1 for language of the Act and a comparison of the bills)
Historically, one of the key challenges to the passage of any expansion of telemedicine reimbursement has been the lack of data upon which to judge its impact on government expenditures. The Office for the Advancement of Telehealth (OAT) has worked with the Center for Telemedicine Law (CTL) and OAT's grantees to develop a series of cost models that would provide a more accurate estimate of the impact of expanded coverage on third party payers. These "scoring" models have the advantage of being able to use actual telemedicine experience from the field. Preliminary results suggest that many of the modest telemedicine reimbursement expansions introduced in the 106th Congress would have minimal impact on Medicare expenditures. (For example, CTL/OAT estimates of Senate Bill 2505 budgetary impact range from $50 to $100 million over five years as compared to an estimate of over a billion dollars scored for legislation in earlier years.)
Arkansas, California, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Montana, Nebraska, North Carolina, North Dakota, South Dakota, Oklahoma, Texas, Utah, Virginia, and West Virginia. In addition, Connecticut, Maine and Minnesota are piloting telemedicine programs.
Sources: CTL "Medicaid Telemedicine and Telehealth Update", July 2000, Health Care Finance Administration http://www.hcfa.gov/medicaid/telemed.htm
In addition to Medicare payments for telemedicine, 20 state Medicaid programs as shown in Box 1 and several state Blue Cross/Blue Shield plans, as well as some other private insurers, pay for select telemedicine services. Several states have recently passed laws that prohibit insurers from discriminating between regular medical and telemedicine services' reimbursement. These states include California, Texas and Louisiana.
Some private insurers also provide limited telemedicine coverage in certain states. For example, Blue Cross-Blue Shield in Montana and North Dakota provides some telemedicine coverage and Blue Cross of California is going a step further by developing a statewide telemedicine network. In July 1999, the Managed Risk Medical Insurance Board awarded $1.8 million to Blue Cross California to expand telemedicine capabilities throughout California. Blue Cross planned to use the funds to expand services at 17 existing clinics to serve medically underserved populations and to provide equipment and support to 22 new telemedicine sites in 18 counties.
***OAT will collaborate with HCFA, state Medicaid programs, private third party payers and other relevant organizations to create a forum in which the experiences of third party payers with telemedicine can be shared.
***OAT will continue to refine its telemedicine scoring models for a broad range of telemedicine applications.
3Medicare has historically reimbursed some telemedicine services that did not traditionally require face-to-face contact between a patient and practitioner. For example, Medicare covered EKG or EEG interpretation, teleradiology, and telepathology in most areas of the nation, in accordance with individual Medicare carrier policies.
Comparison of Legislative Bills Relating to Telemedicine Reimbursement Comparison of Legislative Bills Relating to Telemedicine Reimbursement
Feature S. 2505 H.R. 5291 Ways and Means H.R. 4577 Title Telehealth Improvement and Modernization Act of 2000 Revision of Medicare Reimbursement for Telehealth Services Section 324: Expansion of Medicare Payment for Telehealth Services Revision of Medicare Reimbursement for Telehealth Services Reimbursement Secretary shall pay to a physician or practitioner at a distant site that provides an item or service the amount equal to that if it had been provided without telehealth. Not later than April 1, 2001 HHS shall pay for telemedicine services that would be made under part B, Title XVIII of SSA. Same as Senate. Secretary shall pay to a physician or practitioner at a distant site that furnishes a telehealth service to an eligible telehealth individual and amount equal to that if it had been provided without use of a telecommunications system. Facility Fee An amount equal to:1) for 2000 and 2001, $20; and2) for a subsequent year, the facility fee will be increased by the percentage increase in the MEI Same as Senate except facility fee begins April 1,2001 and runs through 2002 at $20. Same as Senate except facility fee for July 1, 2001 through December 2001 and for 2002 is $20. Balanced billing explicitly prohibited. An amount equal to:1) for 7/1/01 through 2002, $20; and 2) for a subsequent year, the facility fee will be the same as 1) or increased by the percentage increase in the MEI Site Eligible for Facility Fee Tier 1:On or before January 1, 2002:1) the office of a physician or practitioner;2) a critical access hospital;3) a rural health clinic; and4) a Federally qualified health center.Tier 2On or before January 1, 2003: 1) a hospital;2) a skilled nursing facility;3) a comprehensive outpatient rehabilitation facility;4) an ambulatory surgical center;5) an Indian Health Service facility; and 6) a community mental health center. Tier 1 Same sites as Senate except coverage begins on or after April 1, 2001.Tier 2 On or before January 1, 2002:1) a hospital;2) a skilled nursing facility;3) a comprehensive outpatient rehabilitation facility;4) a renal dialysis facility;5) an ambulatory surgical center;6) a hospital or skilled nursing facility of the Indian Health Services; and7) a community mental health center Includes only those sites listed below and only if the site is located in a HPSA that is located in all or part of a rural area:1) The office of a physician or practitioner;2) A rural health clinic;3) A Federally Qualified Health Center; and4) A critical access hospital Originating Site:1) An area designated as a rural health professional shortage area2) In a county that is not in a MSA3) A Federal telemedicine demonstration project. Sites: 1) The office of a physician or practitioner;2) A critical access hospital;3) A rural health clinic;4) A Federally Qualified Health Center; and5) A hospital Telepresenter Telepresenter not required Same as Senate except, "unless it is medically necessary as determined by the physician or practitioner at the distant site". Except for certain psychiatric services, an individual shall be presented by a physician or practitioner or an RN. Telepresenter not required, unless it is medically necessary (as determined by the physician or practitioner at the distant site). Geographical Area Covered Applies to eligible Telehealth Beneficiaries residing in:1) a HPSA; 2) a county not included in a Metropolitan Statistical Area; and 3) an inner-city area that is medically underserved. Same as the Senate except: An inner city that is considered medically underserved effective January 1, 2002, and a facility which participates in a Federal telemedicine demonstration project. Same as Sites Eligible for Facility Fee. Only if the site is located in a HPSA that is located in all or part of a rural area:1) The office of a physician or practitioner; 2) A rural health clinic;3) A Federally Qualified Health Center; and4) A critical access hospital Originating Sites including:1) An area designated as a rural health professional shortage area2) In a county that is not in a MSA3) A Federal telemedicine demonstration project. Codes Covered
Payment will be made for professional consultations, office visits, office psychiatry services, including any service identified as of July 1, 2000, by HCPCS codes 99241-99275, 99201-99215, 90804-90815, and 90862, and any additional item or service specified by the Secretary.
Additionally: Directs Secretary to identify appropriately covered services and to report back 2 years within enactment of the legislation.
Same as Senate except for coding: Codes covered include 99241-99275, 99201-99215, 90804-90809 and 90862.
Additionally: Directs Secretary to identify appropriately covered services and to report back within 2 years of enactment of the legislation.
Same as Senate, except for coding: Codes covered include 99241-99275, 99201-99215, 90804-90809 and 90862.
Also, directs the Comptroller General to conduct a study similar to that called for in Senate bill and requires a report in 3 years.
telehealth service means professional consultations, office visits, and office psychiatry services (identified as of July 1, 2000, by HCPCS codes codes 99241-99275, 99201-99215, 90804-90809, and 90862, and as subsequently modified by the Secretary.
Additionally, requires the Secretary to establish a process that provides, on an annual basis, for the addition or deletion of services (and HCPCS codes) as appropriate
Eligible Telehealth Providers Expands upon physician only provision in BBA by adding: 1) a practitioner described in section 1842(b)(18)(C) of the Social Security Act; and 2) physical, occupational or speech therapist. Same as Senate except it does not include physical, occupational or speech therapists Refers to physicians and practitioners but does not define them. A physician, (as defined in section 1861 ( r) or a practitioner as described in section 1824 (b)(18)( C) Home Health
Nothing in this section or in section 1895 of the Social Security Act (42 U.S.C. 1395fff) shall be construed as preventing a home health agency furnishing a home health unit of service for which payment is made under the prospective payment system established in such section for such units of service from furnishing the service via a telecommunications system.
LIMITATION- Nothing in this section shall require the Secretary to consider a home health service provided in the manner described in paragraph (1) to be a home health visit for purposes of--`(A) determining the amount of payment to be made under such prospective payment system; or`(B) any requirement relating to the certification of a physician required under section 1814(a)(2)(C) of such Act (42 U.S.C. 1395f(a)(2)(C)).
Same as the Senate, except the language "via a telecommunication system" is excluded. Section 504 states:Nothing in this section shall be construed as preventing a home health agency furnishing a home health unit of service for which payment is made under the PPS established by this section for such units of service from furnishing services via a telecommunication system if such services:1. Do not substitute for home health services ordered as part of a plan of care certified by a physician; and2. Are not considered to be a home health visit for purposes of eligibility or payment under this title. Nothing in this section shall be construed as preventing a home health agency furnishing a home health unit of service for which payment is made under the prospective payment system established by this section for such units of service from furnishing services via a telecommunications system if such services - (A) do not substitute for in-person home health services ordered as part of a plan of care certified by a physician; and (B) are not considered a home health visit for purposes of eligibility or payment under this title. Store and Forward Re: Section 4206(a)(1) of the BBA, in the case of any Federal telemedicine demonstration program in Alaska or Hawaii, the term "telecommunications system" includes store-and-forward technologies that provide for the asynchronous transmission of health care information in a single or multimedia format(s). Same as Senate No provision. In the case of any Federal telemedicine demonstration program conducted in in Alaska or Hawaii, the term "telecommunications system" includes store-and-forward technologies that provide for the asynchronous transmission of health care information in single or multimedia formats. Fee Sharing and Payment of Presenter Fee sharing provisions in BBA '97 are eliminated. Same as Senate Nothing prohibits the physician or practitioner from sharing a portion of the fee that he or she receives from Medicare for an eligible teleheath service with a physician or practitioner who serves as a telepresenter at the originating site;Payment for an RN who serves as a telepresenter shall be made by the distant site physician or practitioner or the originating site facility that is the RNs employer;The provisions of section 1877 shall apply to payments that a physician or practitioner at a distant site makes to a referring physician or practitioner who does not serve as a telepresenter at the originating site. Fee sharing provisions in BBA '97 are eliminated.
The Medicare, Medicaid, and SCHIP Benefits Improvements and Beneficiary Protection Act of 2000, Section 223 The Medicare, Medicaid, and SCHIP Benefits Improvements and Beneficiary Protection Act of 2000, Section 223
The following was taken from http://thomas.loc.gov/cgi-bin/bdquery/z?d106:HR04577:|TOM:/bss/d106query.html|
114 STAT. 2763A487 PUBLIC LAW 106554APPENDIX F SEC. 223. REVISION OF MEDICARE REIMBURSEMENT FOR TELEHEALTH SERVICES.
(a) TIME LIMIT FOR BBA PROVISION.Section 4206(a) of BBA (42 U.S.C. 1395l note) is amended by striking Not later than January 1, 1999 and inserting For services furnished on and after January 1, 1999, and before October 1, 2001.
(b) EXPANSION OF MEDICARE PAYMENT FOR TELEHEALTH SERVICES. Section 1834 (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:
(m) PAYMENT FOR TELEHEALTH SERVICES.
(1) IN GENERAL.The Secretary shall pay for telehealth services that are furnished via a telecommunications system by a physician (as defined in section 1861(r)) or a practitioner (described in section 1842(b)(18)(C)) to an eligible telehealth individual enrolled under this part notwithstanding that the individual physician or practitioner providing the telehealth service is not at the same location as the beneficiary. For purposes of the preceding sentence, in the case of any Federal telemedicine demonstration program conducted in Alaska or Hawaii, the term telecommunications system includes store-and-forward technologies that provide for the asynchronous transmission of health care information in single or multimedia formats.
``(2) Payment amount.--
``(A) Distant site.--The Secretary shall pay to a physician or practitioner located at a distant site that furnishes a telehealth service to an eligible telehealth individual an amount equal to the amount that such physician or practitioner would have been paid under this title had such service been furnished without the use of a telecommunications system.
``(B) Facility fee for originating site.--With respect to a telehealth service, subject to section 1833(a)(1)(U), there shall be paid to the originating site a facility fee equal to--
``(i) for the period beginning on October 1, 2001, and ending on December 31, 2001, and for 2002, $20; and
``(ii) for a subsequent year, the facility fee specified in clause (i) or this clause for the preceding year increased by the percentage increase in the MEI (as defined in section 1842(i)(3)) for such subsequent year.
``(C) Telepresenter not required.--Nothing in this subsection shall be construed as requiring an eligible telehealth individual to be presented by a physician or practitioner at the originating site for the furnishing of a service via a telecommunications system, unless it is medically necessary (as determined by the physician or practitioner at the distant site).
``(3) Limitation on beneficiary charges.--
``(A) Physician and practitioner.--The provisions of section 1848(g) and subparagraphs (A) and (B) of section 1842(b)(18) shall apply to a physician or practitioner receiving payment under this subsection in the same manner as they apply to physicians or practitioners under such sections.
``(B) Originating site.--The provisions of section 1842(b)(18) shall apply to originating sites receiving a facility fee in the same manner as they apply to practitioners under such section.
``(4) Definitions.--For purposes of this subsection:
``(A) Distant site.--The term `distant site' means the site at which the physician or practitioner is located at the time the service is provided via a telecommunications system.
``(B) Eligible telehealth individual.--The term `eligible telehealth individual' means an individual enrolled under this part who receives a telehealth service furnished at an originating site.
``(C) Originating site.--
``(i) In general.--The term `originating site' means only those sites described in clause (ii) at which the eligible telehealth individual is located at the time the service is furnished via a telecommunications system and only if such site is located--
``(I) in an area that is designated as a rural health professional shortage area under section 332(a)(1)(A) of the Public Health Service Act (42 U.S.C. 254e(a)(1)(A));
``(II) in a county that is not included in a Metropolitan Statistical Area; or
``(III) from an entity that participates in a Federal telemedicine demonstration project that has been approved by (or receives funding from) the Secretary of Health and Human Services as of December 31, 2000.
``(ii) Sites described.--The sites referred to in clause (i) are the following sites:
``(I) The office of a physician or practitioner.
``(II) A critical access hospital (as defined in section 1861(mm)(1)).
``(III) A rural health clinic (as defined in section 1861(aa)(s)).
``(IV) A Federally qualified health center (as defined in section 1861(aa)(4)).
``(V) A hospital (as defined in section 1861(e)).
``(D) Physician.--The term `physician' has the meaning given that term in section 1861(r).
``(E) Practitioner.--The term `practitioner' has the meaning given that term in section 1842(b)(18)(C).
``(F) Telehealth service.--
``(i) In general.--The term `telehealth service' means professional consultations, office visits, and office psychiatry services (identified as of July 1, 2000, by HCPCS codes 99241-99275, 99201-99215, 90804-90809, and 90862 (and as subsequently modified by the secretary)), and any additional service specified by the Secretary.
``(ii) Yearly update.--The Secretary shall establish a process that provides, on an annual basis, for the addition or deletion of services (and HCPCS codes), as appropriate, to those specified in clause (i) for authorized payment under paragraph (1).''.
(c) Conforming Amendment.--Section 1833(a)(1) (42 U.S.C. 1395l(1)), as amended by section 105(c), is further amended--
(1) by striking ``and (T)'' and inserting ``(T)''; and
(2) by inserting before the semicolon at the end the following: ``, and (U) with respect to facility fees described in section 1834(m)(2)(B), the amounts paid shall be 80 percent of the lesser of the actual charge or the amounts specified in such section''.
(d) Study and Report on Additional Coverage.--
(1) Study.--The Secretary of Health and Human Services shall conduct a study to identify--
(A) settings and sites for the provision of telehealth services that are in addition to those permitted under section 1834(m) of the Social Security Act, as added by subsection (b);
(B) practitioners that may be reimbursed under such section for furnishing telehealth services that are in addition to the practitioners that may be reimbursed for such services under such section; and
(C) geographic areas in which telehealth services may be reimbursed that are in addition to the geographic areas where such services may be reimbursed under such section.
(2) Report.--Not later than 2 years after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the study conducted under paragraph (1) together with such recommendations for legislation that the Secretary determines are appropriate.
(e) Effective Date.--The amendments made by subsections (b) and (c) shall be effective for services furnished on or after October 1, 2001.
The Medicare, Medicaid, and SCHIP Benefits Improvements and Beneficiary Protection Act of 2000, Section 504 The Medicare, Medicaid, and SCHIP Benefits Improvements and Beneficiary Protection Act of 2000, Section 504
The following was taken from http://thomas.loc.gov/cgi-bin/bdquery/z?d106:HR04577:|TOM:/bss/d106query.html|
114 STAT. 2763A531 PUBLIC LAW 106554APPENDIX F SEC. 504. USE OF TELEHEALTH IN DELIVERY OF HOME HEALTH SERVICES.
Section 1895 (42 U.S.C. 1395fff ) is amended by adding at the end the following new subsection:
(e) CONSTRUCTION RELATED TO HOME HEALTH SERVICES.
(1) TELECOMMUNICATIONS.Nothing in this section shall be construed as preventing a home health agency furnishing a home health unit of service for which payment is made under the prospective payment system established by this section for such units of service from furnishing services via a telecommunication system if such services
(A) do not substitute for in-person home health services ordered as part of a plan of care certified by a physician pursuant to section 1814(a)(2)(C) or 1835(a)(2)(A); and
(B) are not considered a home health visit for purposes of eligibility or payment under this title.
(2) PHYSICIAN CERTIFICATION.Nothing in this section shall be construed as waiving the requirement for a physician certification under section 1814(a)(2)(C) or 1835(a)(2)(A) of such Act (42 U.S.C. 1395f(a)(2)(C), 1395n(a)(2)(A)) for the payment for home health services, whether or not furnished via a tele-communications system..
How E-health Companies Seek to Protect Themselves From Liability
To protect themselves from liability, e-health companies have utilized various disclaimers in the form of user agreements that attempt to limit the potential liability of e-health companies. These user agreements are extensive and attempt to cover every conceivable possible ground of liability against an e-health company. They are often prominently displayed in e-health websites and the use of a “clickwrap” to force users to acknowledge the agreement have been liberally utilized. The enforceability of user agreements has not been extensively tested in courts.
E-health websites often use mandatory arbitration clauses and/or forum selection clauses in their user agreements in an attempt to minimize liability
Safety and Standards
***Next Steps Overview
Thanks to advances in technology, telemedicine practitioners have shifted easily from the phone to the personal computer to the Internet to wireless handheld devices. Yet, the full potential of these advances cannot be reached without clinical and technical standards and guidelines.
In the past few years, the need for standards has taken on greater importance, not only in the world of telemedicine, but also in the world at large. Without widely adopted standards and guidelines, interoperability and interconnection are not possible and the great potential of telemedicine will be difficult to achieve. Older equipment often will not connect with newer versions of the same machine; different brands do not operate with one another, making networking across projects and sometimes within a project expensive and frustrating.
In addition to technical standards, clinical protocols and guidelines are needed. Clinical protocols for telemedicine practice include preliminary scheduling procedures, actual consult procedures and telemedicine equipment operation procedures (such as telecommunications transmission specifications). The clinical technical standard for image quality in a video transmission would specify the technical standards needed by a specialist such as a dermatologist to achieve the high levels of image clarity and color required to correctly diagnose a patient.
Unlike most clinical health professional groups, U.S. telemedicine practitioners have not formally developed and adopted many clinical protocols or technical standards for telehealth applications. However, a few professional associations have adopted some clinical practice protocols.
*** The American Telemedicine Association recently adopted Telehomecare Clinical Guidelines, posted on their Web site at http://www.atmeda.org/news/guidelines.html. Additionally, the Association has posted a May 1999 working draft of its Clinical Guidelines for Telepathology.
***The American Psychological Association has posted clinical guidelines on its Web site to guide in the practice of telepsychiatry.
*** The American Dermatology Association has drafted proposals for clinical protocols for teledermatology.
***The American Nurses Association, assisted by the Interdisciplinary Telehealth Standards Working Group, developed the "Core Principles on Telehealth" in March 1998 and "Competencies in Telehealth Technologies in Nursing in March 1999.
The following is a short list of technical standards and guidelines that have been adopted or have been proposed that relate directly or indirectly to telemedicine and telehealth.
*** The American College of Radiology and the National Electronic Manufacturers Association created a uniform set of communication standards called DICOM (Digital Imaging and Communications in Medicine).
***HL 75: standard for data exchange. The most widely used HL7 specification is the Application Protocol for Electronic Data Exchange in Healthcare Environments. This is a messaging standard that enables disparate healthcare applications to exchange data.
*** Kennedy-Kassebaum Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandated the development and adoption of standards for electronic exchange of health information for administrative purposes. As of December, 2000 DHHS released its final rule on privacy practices for covered entities such as health plans, clearing houses and providers who engage in electronic transactions.
***OAT and the JWGT organized a workshop in September 1999 to address the need for guidelines in the area of technical standards for telemedicine practice. Several guidelines have already been completed for telecardiology, teledermatology, telerehabilitation, teleopthamology and tele-psychiatry. (See: http://telehealth.hrsa.gov/pubs.htm) Additionally, OAT has funded a grant to the Advanced Technology Institute to develop a technical assessment center. This Telehealth Deployment Research Test bed will establish a national distributed test bed that will evaluate the effectiveness and practical utility of telehealth technologies by providing laboratory and "real world" evaluations. FDA Regulatory Role
Widely adopted standards and guidelines not only serve as a foundation for interoperability and interconnection but also to protect public health. The US Federal Food and Drug Administration (FDA) plays a critical regulatory role in ensuring the safety and effectiveness of telemedicine medical devices and software with the Center for Devices and Radiological Health (CDRH) acting as lead agency. This role was discussed at length in the Department of Commerce's 1997 Report to Congress on Telemedicine (See Appendix 5).
Over the past five years, the FDA has continued its oversight of medical devices and software associated with telemedicine, developed guidelines, and provided assistance to industry and other regulators through the work of several telemedicine related working groups. For example, the Telemetry Working Group worked with the FCC to provide new spectrum for wireless medical service after digital TV signals interfered with wireless medical telemetry equipment in 1999. The Software Working Group has developed guidelines for software contained in Medical Devices and the Telemedicine Working Group has developed guidelines on Medical Image Management Devices, on Digital Mammography and Picture Archiving and Communications Systems and Related Devices. Given the growing importance of the home health industry, the FDA and the National Science Foundation cosponsored the "Workshop on Home Care Technologies for the 21st Century." The FDA also recently approved Tele-homecare equipment for market. Current telemedicine related FDA guidelines can be found at the following sites:
*** Guidance for the Submission of Premarket Notification for Medical Image Management Devices, (7/27/2000) http://www.fda.gov/cdrh/ode/guidance/416.pdf.
*** Guidance for Industry: Wireless Medical Telemetry Risks and Recommendations (9/27/2000) http://www.fda.gov/cdrh/comp/guidance/1173.html
*** FDA Talk Paper: FDA approves first digital mammography system. (1/31/2000) http://www.fda.gov/bbs/topics/ANSWERS/ANS01000.html
*** ODE: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. (5/27/98) http://www.fda.gov/cdrh/ode/57.html or http://www.fda.gov/cdrh/ode/software.pdf
*** MQSA Regulations relevant to new mammographic modalities are in 21CFR900: Quality Mammography Standards (as amended): http://www.fda.gov/cdrh/mammography/frmamcom2.html#12
Alabama, Arizona, California, Florida, Iowa, Idaho, Kansas, Maine, Mississippi, Nebraska, New York, Ohio, Virginia
Another notable change in FDA's role in telehealth is its growing involvement in the oversight of relevant Internet activities. Over the past few years, some Web sites have offered illegal drugs or prescription drugs based on questionnaires rather than a face-to-face examination by a licensed health care practitioner. Some off-shore sites offer prescription drugs with any prescription. The FDA is working with the National Association of Boards of Pharmacy (NABP), which created a program in 1999 called Verified Internet Pharmacy Practice Sites or VIPPS.
The program gives consumers a single place to check out an online pharmacy to ensure that it meets current standards. To become certified by VIPPS, an online pharmacy must meet the licensing and inspection requirements in the state where it is located and in each state to which it dispenses pharmaceuticals. The FDA has also worked with the Federation of State Medical Boards on prescribing issues. The FDA's role in this area compliments that of the Federal Trade Commission, a key player in enforcement (see below). Moreover, states remain primarily responsible for regulating and licensing of health care providers and pharmacies. About 13 states have recently passed laws that require a physical examination before prescribing medication either over the phone or over the Internet, as shown in Box 4 .
A number of federal and state regulatory agencies are working together to address health-related consumer problems on the Internet. They include state health authorities, the Federal Food and Drug Administration, the Justice Department, and the Federal Trade Commission. The Federal Trade Commission plays a key oversight and enforcement role in Internet Commerce as illustrated in its December 1999 Report. In this report the Commission discusses its activities to combat general consumner fraud and deception on the Internet. Since 1994, it has focused on the largest and "most egregious" fraud and deception examples, taking action against companies in more than 100 cases. As shown in Box 5, the Commission has made false or unsubstantiated health claims online a law enforcement priority.
Operation cure-all: The Commission brought four cases against the marketers of products such as magnetic therapy devices, shark cartilage and CMO. (cetymyristoleate) for their claims that these products could cure a host of serious diseases, including cancer, HIV/AIDS, multiple sclerosis and arthritis. All the companies, which used Web sites to market the products and recruit distributors, entered into settlements with the Commission.
FTC v. Slim America, Inc.: The defendants were charged with falsely advertising that their weight loss product would produce dramatic weight loss results. After a trial, the Court ordered the defendants to pay $8.3 million in consumer redress and ordered the individual defendants to post multi-million dollar bonds before engaging in the marketing of weight loss or other products and services.
FTC v. American Urological Clinic: The defendants touted "Vaegra," a sham "Viagra" and other impotence treatment products, claiming that the products had been developed by legitimate medical enterprises and proven effective. The Commission obtained an $18.5 million judgment. that requires the defendants to post a $6 million bond before they promote any impotence treatment in the future.
Despite the actions of regulators, consumers must bear the major burden of determining the safety and privacy of health related Web sites that they use. Several US Government-sponsored Web sites for consumer health information are reviewed and links are carefully selected, with the selection criteria described on each site. Several years ago, DHHS introduced its Web based "healthfinder®" - an Internet Web site (http://www.healthfinder.gov) that provides search capabilities on health information. Healthfinder® includes links to other important government health sources such as Medlineplus (http://medlineplus.gov/), created by the National Library of Health. Other links to the Center for Disease Control, the FDA and the National Cancer Institute name just a few of the myriad Federal government health information sources. While the Federal government has made credible health information more accessible to consumers on the Web, private and non-profit company Web sites have also proliferated. These health-oriented Web sites range widely from those providing general health information to those selling pharmaceuticals to those that provide a medical opinion for a fee.
For any such Web site, consumers may find it difficult to determine the "quality" of the site. Consequently, the DHHS' national Healthy People 2010 initiative includes the goal of increasing the number of health related Web sites that disclose quality standards information. "Quality"6 here is defined as more than just the quality of information at the site, including among other things, elements that relate to reliability, value and user protections. Outlined below is the information DHHS recommends be disclosed to users on health related Web sites:
*** Identity of Web site developers
*** Site Owner's/Developer's contact information
*** Potential conflicts of interest/bias
*** Purpose of the site
*** Original sources of content
*** Privacy and confidentiality protection of personal information
*** Site evaluation methodology
*** Content updates
A recent article, Proposed Frameworks to Improve the Quality of Health Web Sites, reviews and compares this DHHS framework to three other frameworks for the Quality of Health Sites. (http://www.medscape.Medscape/GeneralMedicine/journal/2000/v02.n05)
The Institute of Medicine's report, To Err is Human: Building a Safer Health System, brought to public attention data known in the medical community for some time.7 Extrapolating results from a number of studies, the report concluded that 44,000 to 98,000 Americans die each year as a result of medical error. National costs range between $17 billion and $29 billion. Of note, is that these data deal almost exclusively with hospitalized patients. The consensus opinion of experts on human error is that many medical errors are the result of systemic problems rather than specific actions by individuals. Complexity of systems has been repeatedly shown to increase the likelihood that errors will occur.
This relationship between complexity and error may have implications for telemedicine practice. As noted in the Institute of Medicine Report, Telemedicine: A Guide to Assessing Telecommunications in Health Care, published in 1996:
"Telemedicine is not a single technology or a discrete set of related technologies; it is rather, a large and very heterogeneous collection of clinical practices, technologies and organizational arrangements. In addition, widespread adoption of effective telemedicine applications depends on a complex, broadly distributed human infrastructure that is only partly in place and is being profoundly affected by rapid changes in health care, information and communications systems."
This statement clearly identifies and articulates the rationale for a careful, robust and proactive approach to the identification, reporting and analysis of medical errors encountered in the practice of Telemedicine activities.
*** OAT will work with its grantees, the American Telemedicine Association (ATA) and other groups to expand its clinical and technical guidelines. (See http://telehealth.hrsa.gov/pubs.htm for current guidelines.)
***OAT will continue to support the work of the Advanced Technology Institute, in developing a Telehealth Deployment Research Testbed. This work is being conducted in conjunction with the Medical University of South Carolina, West Virginia University Concurrent Engineering Research Center, Arthur D. Little, Oak Ridge National Laboratory, the Low country Healthcare Network and the CPRI-HOST consortium. The testbed will evaluate the effectiveness and practical utility of telehealth technologies by providing both laboratory and "real-world" evaluations.
***OAT will develop a series of measures to be included in its performance measurement data collection system with common data elements to be collected by all OAT grantees. These measures should help document the contribution of telemedicine technologies in reducing the incidence of medical errors. Footnotes
Other Liability Issues Facing E-Health
E-health companies often seek to generate revenue through advertising, the referral of professional services, or the sale of products. Such companies should be concerned about breaches of confidentiality by advertisers on their site, federal and state laws prohibiting self-referrals and kickbacks, and Federal Trade Commission regulation over diagnostic products deemed regulated medical devices. Consideration should also be given to obtaining the approval of third party companies such as eTrust for the revenue generation portion of an e-health company’s website.