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Telehealth Publications

2001 Report to Congress on Telemedicine

Tommy G. Thompson, Secretary
Claude Earl Fox, MD, MPH, Administrator
Department of Health and Human Services
Health Resources and Services Administration

February 2001

Executive Summary top

The Healthcare Research and Quality Act of 1999, Section 6, requires the Secretary of Health and Human Services (DHHS) to submit a Report to Congress on Telemedicine by 2001. Congress requested that the Report describe barriers to telemedicine, determine the extent of patient and physician satisfaction with this mode of health delivery and assess patient benefits from telemedicine services.What exactly is meant by telemedicine and telehealth? In the Department of Commerce's1997 Report to Congress, "telemedicine" referred to "the use of electronic communication and information technologies to provide or support clinical care at a distance."1 Telehealth is a broader concept. For the purposes of this Report, telehealth is defined as the use of electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration.

Current Trends

One of the most important trends to emerge over the past four years is the remarkable growth and development of the Internet. While much of this report focuses on telehealth providers and the barriers they face in expanding the delivery of telehealth, this is only one part of the story. The Internet is dramatically changing the way consumers access health information, receive diagnostics and purchase pharmaceuticals. According to the Federal Trade Commission (FTC), consumer searching for online health information is increasing dramatically; it is predicted that 30 million Americans will seek health information online by 2001.2The Internet will most likely play a key role in expanding the reach of telehealth and telemedicine to the average consumer. However, this potential also brings other concerns about state jurisdiction and enforcement, physician and other health provider cross state licensure, privacy and safety issues, as discussed throughout the Report to Congress.

Key Issues

Key issues affecting the telemedicine and telehealth industry have remained the same over the past five years but their relative importance has changed with the advent of dramatic technology changes such as the wide spread adoption of the Internet. These issues are:

  • Lack of Reimbursement;
  • Legal Issues;
  • Safety and Standards;
  • Privacy, Security and Confidentiality;
  • Telecommunications Infrastructure

Lack of Reimbursement remains a critical barrier to the expansion of telemedicine. Even though technology has made it easier to deliver health care services using advanced communications and computers, historically few public or private payers have covered them..The Balanced Budget Act of 1997 (BBA) expanded coverage options for telemedicine but also included several requirements that preclude telemedicine's use under conditions where it is commonly being used outside of Medicare. The BBA required the Health Care Financing Administration (HCFA) to pay for telemedicine consultation services as of January 1, 1999. Some important reimbursement eligibility requirements are outlined in Table 1.

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."

In the first two years, many telemedicine practitioners have found the requirements under the BBA mandate too narrow for most practical purposes. Between January 1, 1999 and September 30, 2000, HCFA had reimbursed 301 claims for a total of $20,000. Several factors may account for this small number. In particular, four requirements greatly limited the number of consultations eligible for reimbursement:

  • Health Professional Shortage Area (HPSA) Requirement: Medicare paid for telemedicine services only in areas that lack adequate primary care services, even though many rural communities have little or no access to specialists, such as cardiologists or psychiatrists. Often the need for specialty services drives the demand for telemedicine services.
  • Fee sharing requirement: HCFA mandated fee sharing, requiring specialists to provide services at a 75% fee that HFCA then reports as a 100% fee to the IRS. Other problems included accounting and fee tracking. Most rural practitioners are not equipped to track split fees. Finally, 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: Although registered nurses, licensed practical nurses and other similar types of health care professionals were the most common presenters in a telemedicine setting, they are not eligible for reimbursement.
  • Eligible Current Procedural Terminology Codes: The allowable codes greatly restricted what services were reimbursable under the BBA and did not include those commonly used by telemedicine practitioners.

During its last two sessions, Congress introduced over nine bills that addressed some of these limitations. On December 20th, 2000, Congress passed the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act ("the Act"). Among other things, this Act eliminates the fee-split and telepresenter requirements and expands the types of presenters, current procedural terminology codes and geographic area limits that are eligible for reimbursement. ( Table 1). Appendix 1 presents a comparison of bills and a summary of the Act.

Box 1: Medicaid State Coverage

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

Historically, telemedicine reimbursement expansion has been prevented by a lack of data on which to judge changes in government expenditure. The Office for the Advancement of Telehealth (OAT) worked with the Center for Telemedicine Law (CTL) and OAT's grantees to develop a series of cost models that will show the impact of expanding telemedicine coverage on any third party payer's expenditures . These "scoring" models have the advantage of being based on actual telemedicine experience in the field. Preliminary results suggest that many of the modest telemedicine reimbursement expansions introduced in the 106th Congress would have a minimal impact on Medicare expenditures. (For example, CTL/OAT estimates of the budgetary impact of Senate Bill 2505 range from $50 to $100 million over five years, as compared to the estimate of over a billion dollars for legislation in earlier years.)

Aside from Medicare reimbursement, 20 state Medicaid programs now reimburse for telemedicine services and three other states are conducting pilot programs to assess telemedicine efficacy as shown in Box 1. Some private insurers also provide limited telemedicine coverage in certain states. For example, California Blue Cross is currently funding the build-out of a statewide telemedicine network. Blue Cross- Blue Shield in Montana and North Dakota also provides some telemedicine coverage. Legal Issues, particularly those relating to cross-state licensure, were thought to be among the most critical to the expansion of telemedicine five years ago. Today, traditional licensure issues remain important, but telemedicine practitioners have found that they can provide many in state services. Moreover, consumer use of the Internet (which knows no borders) for health related information, purchase of prescription drugs and online consultations may create new legal and licensure issues, overshadowing the more traditional issues. For example, a consumer, located in state A, sues a health practitioner in state B, who has provided consultations to the consumer via a Web site. Who has jurisdiction in this case? How easily can state A enforce its state health licensure laws if the health practitioner is not licensed in state A?

Box 2: States that Adopted the Compact

Arkansas, Delaware, Iowa, Maine, Maryland, Mississippi, Nebraska, North Carolina, South Dakota, Texas, Utah and Wisconsin.

Currently, about 26 states have laws regulating out-of-state telemedicine practitioners. Twenty-one require full licensure for an out-of state physician, providing telemedicine services to a patient located in that state. The other five states approach licensure in a variety of ways, such as California's registration requirement or Hawaii's permit for out-of-state physician to provide consultation to an in-state licensed physician. A list of states' licensure laws is shown in Appendix 2.

While many more states restrict physician's interstate telemedicine practice, 12 states have adopted the Interstate Nurses Licensure Compact as shown in Box 2. The compact is a licensure model based on mutual recognition. Under it, the head of the nursing licensing board will administer the Compact for his/her state.

Safety and Standards have taken on greater importance in the past few years, 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 interconnect with newer versions of the same machine. Different brands of the same equipment will not operate with one another, making networking across projects and sometimes within a project expensive and frustrating.

In addition to technical standards, there is a need for clinical protocols and guidelines. Examples of 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. Only a few professional associations have adopted either clinical practice protocols or technical standards and guidelines, as shown in Table 2. Additionally, some government agencies have worked to develop technical guidelines for telemedicine interoperability.

TABLE 2: Telemedicine Standards and Guidelines

Organization Standards and Guidelines
American Telemedicine Association (ATA) Telehomecare Clinical Guidelines: http://www.atmeda.org/news/guidelines.html. ATA has also posted a May 1999 working draft nes, posted at of its Clinical Guidelines for Telepathology.
American Psychological Association (APA) Clinical Telepsychology guidelines posted on its Web site at http://www.apa.org/ethics/stmnt01.html
American Dermatology Association The American Dermatology Association has drafted proposals for clinical protocols for teledermatology.
American Nurses Association Clinical Core Principles on Telehealth, March 1998; Competencies in Telehealth Technologies in Nursing, March 1999
American College of Radiology/ National Electronic Manufacturers Association Digital Imaging and Communication in Medicine (DICOM) Standards a uniform set of communication standards.
Health Level Seven HL7 Standard for data exchange
Kennedy Kassebaum Health Insurance Portability Act Under the Administrative Simplification provision of HIPAA, the Act mandates the development and adoption of national electronic health transaction standards.
Office for the Advancement of Telehealth Practical technical guidelines based on OAT Grantee experiences at http://telehealth.hrsa.gov. These guidelines are a work in progress. Currently include specifications for teledermatology, teleopthamology, emergency medical, telecardiology,telerehab. OAT has also funded a grant to develop a technical assessment center.

Just as the wide adoption of telemedicine standards and protocols plays an important role in protecting public safety, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) play a critical regulatory role. The FDA ensures the safety and effectiveness of telemedicine medical devices and software, with the Center for Devices and Radiological Health (CDRH) as the lead agency. In oversight of telemammography -- regulating standards, personnel, practice and procedures -- the FDA plays an even more critical role.

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, FDA, the Justice Department and FTC. FTC plays a key oversight and enforcement role in Internet Commerce as illustrated in its December 1999 Report: Protecting Consumers Online: A Federal Trade Commission Report on the First Five Years of Its Internet Law Enforcement Program. In this report, the Commission discusses its activities to combat general consumer 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.

Privacy, Security and Confidentiality concerns are not unique to telemedicine. The U.S. Congress and individual state legislatures are all but certain to consider a wide range of privacy-related Internet legislation that could affect many industries next year. However, the unique privacy problems associated with personal patient information, such as HIV status, cancer or mental health, raise many important questions about personally identifiable information and its protection.

An important national privacy measure that may affect the telemedicine industry is the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Under the Administrative Simplification provision of HIPAA, the Act mandates the development and adoption of a number of national electronic health transaction standards, including standards for electronic data exchange of health information; 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), 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 can be found at: http://aspe.hhs.gov/admnsimp.

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.

HIPAA rules cover health plans (e.g., insurers, managed care organizations, federal health programs), 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.

Potentially the most challenging issue for telemedicine practitioners will be DHHS' proposal for federal privacy law to preempt state law only when states are less stringent. Thus, if state requirements are in conflict with federal ones, the rules providing more stringent privacy protections would prevail. Telemedicine practitioners could be faced with a patchwork of state privacy standards.

State laws governing health information exhibit wide discrepancies in protection, complexity and coverage as illustrated by a 50-state survey4 of health privacy statutes that can be found at the Health Privacy Project Web site at: http://www.healthprivacy.org/resources/statereports/exsum.html.

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 privacy rules may affect telemedicine practitioners and patients.

Although a detailed discussion of consumer privacy and the Internet is beyond the scope of this Report, it is of growing concern to the public. To address this problem, industry has promoted self-regulatory mechanisms such as standards for Web sites. The Health on the Net Foundation (HON) (http://www.hon.ch) and TRUSTe (http://www.TRUSTe.org) have developed some of the most widely accepted standards and "privacy seals." "Ethical principles" or "Ecodes" are another alternative. Two new industry coalitions called the Internet Healthcare Coalition (http://www.ihealthcoalition.org/ethics/ecode.html) and the Health Internet Ethics Coalition have promoted this type of self-regulation.

Despite industry's efforts to self regulate, agencies, such as the FTC, have found that industry self-regulation is not sufficient to protect consumer privacy on the Internet. In its report entitled, Privacy Online: Fair Information Practices in the Electronic Marketplace, May 2000, (http://www.ftc.gov/os/2000/05/index.htm#22) 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."5 These 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: Offer 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.

Telecommunications Infrastructure costs continue to represent a large percentage of overall costs in a telemedicine project's monthly budget. To alleviate some of this burden, the Telecommunications Act of 1996 charged the FCC to administer the Universal Service program, which 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, to oversee both the E-Rate discount for Schools and Libraries and the Rural Health Care Program (RHCD). USAC's 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). In the first year, few providers completed applications for the discount, because most found they could not benefit from it under the original program.

Since the first year, the FCC has adopted a number of reforms to the program, which streamlines the discount application process, and addresses practical concerns voiced by practitioners and others. ( Appendix 5 provides a detailed history of RHCD and OAT's FCC filing on Universal Service or at http://telehealth.hrsa.gov/pubs.htm). Funding in the second year of the program, after reforms were implemented, increased to $6.1 million. Moreover the FCC and USAC expect that third year funding will increase to nearly $10 million, once all reforms have been in place for a full year.

Research and Evaluation

Few statistically significant studies of patient/ physician satisfaction or telemedicine cost savings have been conducted. This dearth of research may be due to the relatively small number of telemedicine consultations in any one specialty and/or to the lack of a standard evaluation methodology to study either efficacy or patient/physician satisfaction across small groups of specialties and projects.

Despite the lack of statistical significance in most of the studies, all showed high patient satisfaction with telemedicine as shown in Table 3. 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.

TABLE 3: Patient/Provider Satisfaction with Telemedicine

Name of Report No. of Studies Reviewed by Report Patient Satisfaction Physician Satisfaction Strengths/
Weaknesses
Health and Human Services Dept. and Univ. of Oregon 30 studies Highly satisfied Highly satisfied 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

Highly satisfied

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.
Assoc. of Telehealth Service Providers (1999) Study based on 132 network responses Not applicable Moderate to Highly Satisfied Large survey of users/ only looks at technology and users.

Emerging Trends and Policy Issues

Two important trends that may greatly affect the telehealth industry and raise key policy issues are rapid technology changes and America's aging population. Shown below are technology trends that already exist and will most likely be common in the near future.

TABLE 4: Overview of Technology Trends
 
Tech Trends Telehealth Applications Related Policy Issues
Internet Most telehealth transactions may be done over the next generation Internet in video, voice, text, still images etc.: on-line consultations, prescription purchases and administrative transactions.
  • Retrofitting HIPAA and other privacy concerns
  • Blurring of borders and scope of practice.
  • Security issues
Digitization Smart cards, digital medical libraries, compressed video and images, imbedded chips.
  • Interoperability
  • Information inter-exchange
  • Technical standards
Wireless Technology

Hand held computers, mobile videophones, and satellite-based mobile hand-held devices with global access.

Emergency medical applications such as two-way video consultations.

Wireless monitoring in the home. Other home wireless equipment with two way video and peripherals for blood pressure, heart rate, etc. Biosensors, data feedback loop.

  • Electromagnetic Interference
  • Future spectrum bandwidth needs.
  • Interoperability across equipment
  • Interconnection problems
  • Security issues
In addition to technological trends, demographic trends will have an important impact on the health and telehealth industry. The aging of the Baby Boomer generation combined with a longer life expectancy, will most likely mean a large population of "fragile" and chronically ill elderly , many those requiring rehabilitation after hospitalization. Given this demographic trend, according to recent studies and workshops,6 home care medical devices were the fastest growing segment of the medical device industry throughout the 1990s. And with the strong movement toward home health care, tele-homecare will be an important associated trend. 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 living in rural areas. Most of these urban patients cannot drive to local clinics and many require assistance getting from point A to point B. Traveling a mile for such an urban patient may be as onerous as a rural patient's two hundred-mile drive to see a specialist. Reimbursement for both rural and urban patients may be a cost effective policy decision. Studies show tele-homecare can save money by decreasing unnecessary hospital and emergency room admissions. Around the clock monitoring and nurse availability via videoconferencing has helped patients better self-diagnose and maintain drug therapies on schedule. 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.Next Steps Outlined below are some proposed "next steps" for the Office for the Advancement of Telehealth (OAT) and the Joint Working Group on Telemedicine (JWGT). Payment
  • OAT will collaborate with HCFA, state Medicaid programs, private third party payers and other relevant organizations to create a forum in which the telemedicine experiences of third party payers can be shared.
  • OAT will continue to refine its telemedicine scoring models for a broad range of telemedicine applications.
Legal Issues
The JWGT 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 of practitioners and track them across state borders. Safety and Standards
  • 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 currently completed telemedicine application guidelines).
  • OAT will continue to support the work of the Advanced Technology Institute, which is 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.
  • Medical Error reduction: OAT will develop a series of measures to be included in GPRA data elements to be collected by all OAT grantees.
Privacy, Security and Confidentiality
  • OAT together with the Office for the Assistant Secretary of Policy and Evaluation have funded a research paper on "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.
Telecommunications Infrastructure
  • 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." (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 (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. This issue will most likely remain an issue in the near future.
Research and Evaluation
  • OAT will collaborate with other Agencies within DHHS as well as work with JWGT members to develop an evaluation strategy that uses cross-project evaluation methodologies to obtain more generalizable findings.
  • Future evaluations should examine provider satisfaction, quality and cost implications of telemedicine for specific applications such as tele-homecare, teledermatology and mental health.
Introduction top

Overview
The beginning of the new millennium is a time to look back from where we have come and to dream of where we wish to go. For those in health care, the scientific triumphs of the past, such as the eradication of polio and small pox or the development of immunization, point to a future, when closing the health gap between the "haves and have nots" in this country and throughout the world, is possible.

Imagine a world, where no matter who you are or where you are you get the health care you need, when you need it. Such a dream could already be a reality. Technologies such as interactive videoconferencing, the Internet, store-and-forward imaging, streaming media, satellite and other wireless communications networks already exist and can deliver health services or education over vast distances. However, these are not yet part of the landscape for our nation's rural and urban underserved peoples.
Although these technologies are available, several barriers, such as the lack of significant reimbursement, cross-state licensure problems, privacy issues, lack of universal standards and high transmission costs, have inhibited the telemedicine and telehealth industry from reaching its full potential in the United States.

In addition to these traditional barriers, the dramatic growth and use of the Internet by health consumers poses new challenges. Despite its great benefits, such as a wealth of health information or fingertip access to prescription drugs, the Internet has created serious threats to industry expansion. These include new legal, safety, privacy and confidentiality concerns for the telemedicine industry.

The Healthcare Research and Quality Act of 1999, Section 6, requires the Secretary of Health and Human Services (DHHS) to submit this Report to Congress on Telemedicine, no later than January 10, 2001. Congress requested the Report describe barriers to telemedicine, determine the extent of patient and physician satisfaction with this mode of health delivery and evaluate the extent to which patients have benefitted from telemedicine services.

What exactly is meant by telemedicine and telehealth? In the Department of Commerce's 1997 Report to Congress, "telemedicine" referred to "the use of electronic communication and information technologies to provide or support clinical care at a distance."1 Telehealth is a broader concept than telemedicine. For the purposes of this Report, it is defined as the use of electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration.

Current Trends
One of the most important trends to emerge over the past five years is the remarkable growth and development of the Internet. While much of this report focuses on telehealth providers and the barriers they face in expanding the delivery of telehealth, that is only part of the story. The Internet is dramatically changing the way consumers access health information, receive diagnostics and purchase pharmaceuticals. It is also conceivable that soon health providers will move much of their administrative transmissions onto the Internet. Hence, the Internet may greatly affect different aspects of telemedicine and telehealth.

According to the Federal Trade Commission (FTC), consumer online searches for health information are increasing dramatically. Thirty million Americans are expected to seek health information online by 2001.2

To establish a viable presence on the Internet the banking, credit card and retail industry, among others, have found it critical to reassure their consumers about the protection of personally identifiable information. Although online shopping, banking and auction bidding are ubiquitous, what consumer does not worry about the random stealing of information by computer hackers? More insidious is the possibility that entire identities can be stolen after a person's social security and other personal information has been made public on the Internet.

Just as other industries have found the Internet to be both a market boon and privacy bane, so the health industry may find that consumers of health information, prescriptions or other health services on the Internet, may be vulnerable. As the Georgetown University Health Privacy Project notes:

"Although health Web sites now provide a wide range of clinical and diagnostic information; opportunities to purchase products and services; interactions among consumers, patients, and health care professionals; and the capability to build a personalized health record, they have not matured enough to guarantee the quality of the information, protect consumers from product fraud or inappropriate prescribing, or guarantee the privacy of individuals' information."

Structure of the Report
The structure of the Telemedicine Report to Congress, 2001 is similar to that of the 1997 Report. Chapter III describes the current Medicare reimbursement rules for telemedicine, as well as the preliminary outcomes for the first year of this program. Chapter IV discusses legal issues affecting the proliferation of telemedicine and telehealth, including state licensure and electronic health information issues as well as other related issues, such as credentials. Chapter V outlines safety and standards issues, limited to specific telehealth concerns. Chapter VI highlights DHHS privacy rules for personally identifiable health related information that is electronically stored or transferred. This chapter also discusses how these proposed rules may affect telehealth practitioners. Chapter VII examines the Federal Communications Commission's (FCC) Universal Service Administrative Company's (USAC) Rural Health Care Program. This Chapter also highlights recent FCC reforms that address some telehealth practitioner concerns that they consider to be major barriers to applying to the program. Chapter VIII draws upon previous research to summarize the current status of patient and physician satisfaction with telemedicine and anecdotal examples of telemedicine efficacy. The final Chapter IX looks at issues that may emerge over the next few years. Specifically, Congress requests that DHHS report the following:

The extent to which patients receiving telemedicine services have benefitted from them and are satisfied with the treatment received pursuant to the services;
The extent to which medical outcomes for such patients would have differed if telemedicine services had not been available to them;
The extent to which physicians involved with telemedicine services have been satisfied with the medical aspects of the services; and
The extent to which primary care physicians are enhancing their medical knowledge and experience through the interaction with specialists provided by telemedicine consultations.

Payment Issues top

Overview

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 YearsOver 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.) Other Payment Coverage
Box 1
Medicaid State Coverage


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.

Next Steps
  • 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.
Legal Issues top
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.

State Medical Licensure and Licensure Models

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