TELEMEDICINE REPORT TO CONGRESS

January 31, 1997


LEGAL ISSUES--LICENSURE AND TELEMEDICINE

A. OVERVIEW

Telemedicine raises a number of legal concerns regarding licensure and professional accountability, particularly relating to cross-state practice. The purpose of licensing health care professionals is to protect the public from incompetent or impaired practitioners. Although interstate telemedicine is not currently widespread, state licensure laws are perceived as a barrier to the expansion of this type of health care practice in many parts of the country. Recent state action, such as that by Kansas, to tighten current licensure laws in response to telemedicine, have further raised concerns about state licensure.

Congressional interest in the licensure of telemedicine providers has taken the form of requests for information and proposed legislation, but to date no action has been taken. In May 1995, Rep. Ron Wyden (D-OR) offered and withdrew an amendment that would have prohibited states from "directly or indirectly restrict[ing] interstate commerce by prohibiting any licensed physician from conducting a consultation with a licensed provider in another state using any advanced telecommunications service. . ."(1) Then Rep.Wyden's action led, in part, to the call for this report. In addition, Senators Kent Conrad (D-ND) and Bob Kerrey (D-NE) introduced a bill directing the Secretary of Health and Human Services to make an annual report to Congress on licensure barriers to telehealth(2). This bill was introduced on the last day of the 1996 Legislative session and no action was taken. The issue may be re-examined when Congress meets again in 1997.

In response to these concerns, the JWGT issued a contract to the Center for Telemedicine Law for a background paper on licensure issues. The group also heard from the American Medical Association, the Federation of State Medical Boards, the National Council of State Boards of Nursing, the American Telemedicine Association, the Institute of Electrical and Electronics Engineers, and representatives from the Mayo Clinic who discussed their views on licensure. In addition, the JWGT issued a call for comments on licensure to the general public through the Federal Register. These comments, along with those of the various associations and individuals who generously shared their time with the JWGT, were invaluable in the formation of this chapter. Public comments in response to the Federal Register request are found in Appendix C.

In this chapter, we will review the structure of the current licensure system in the United States, alternate approaches for addressing cross-state licensure barriers to telemedicine, and specific proposals for alternatives to the current system. The chapter ends with a brief discussion of professional liability in telemedicine and a summary of future directions and next steps to be taken by the JWGT. Because most current activity regarding telemedicine and licensure centers around physicians, this chapter focuses on this group of health professionals. However, much of the discussion is equally applicable to other health care professionals.

B.THE CURRENT LICENSURE SYSTEM

Currently, each state has established a Medical Practice Act that defines the process and procedures for granting a health professional license, renewing a license, and regulating medical practice within the state.

Historically, interstate physician-to-physician communications have not been subject to licensing requirements. These communications can take a variety of forms including the mailing of x-rays, clinical histories and pathological and laboratory specimens for evaluation and interpretation, and oral or written inquiries to another out-of-state physician involved in the patient's care or in the form of a specific consultative request to a physician with special expertise. In these interstate communications, the consulted physician or other health professional is regarded either as practicing medicine only in his or her home state or as exempt from licensure under the "consultation exception" in the patient's state.

Until recently, few states had addressed issues concerning out-of-state physicians who provide patient health care via electronic communications. Like the state medical practice acts on which they are based, the text of specific telemedicine provisions varies significantly from state to state. In the past several years, Kansas, Nevada, California, Connecticut, Indiana, Oklahoma, South Dakota, Tennessee, and Texas have enacted regulations or legislation governing licensure of out-of-state telemedicine health professionals(3). In virtually all situations, except California, the state has required an out-of-state physician to obtain a full and unrestricted license before consulting directly with patients in the state. Additional states are expected to consider similar measures in the coming year.

Further, in response to inquiries regarding telemedicine, the state medical boards in Arizona, Florida, Iowa, Maine, Massachusetts, Pennsylvania and Virginia have interpreted the state licensure statute to require licensure of most out-of-state telemedicine physicians.(4) Mississippi, however, has interpreted its statutes in a manner which allows out-of-state physicians to render diagnoses regarding patients in that state without a second license.(5)

C.LEGAL FOUNDATION FOR THE U.S. LICENSURE SYSTEM: IMPLICATIONS FOR TELEMEDICINE

To understand the legal implications of professional licensure for telemedicine, one must first examine the structure of the current licensure system in terms of authority, standards, enforcement and administration.

Authority

Licensure authority defines who has the legal responsibility to grant a health professional the permission to practice their profession. The vesting of licensure authority in state, Federal or regional powers raises important constitutional and legal questions beyond the issue of licensure.

State Authority

Historically, under Article X of the U.S. Constitution, states have the authority to regulate activities that affect the health, safety, and welfare of their citizens including the practice of the healing arts within their borders. (See Box 11)(6) However, the states' power to regulate health care may not be absolute because the Commerce Clause of the Constitution limits states' ability to erect barriers against interstate trade(7) and the practice of health care has been held to be interstate trade for the purposes of antitrust laws.(8) Interestingly, the potential conflict between the states' power to regulate health professionals and the prohibition against restraints on interstate commerce has not been addressed by the courts. States may regulate matters of "legitimate local concern" even though interstate commerce may be affected.(9)

Even overt discrimination against interstate trade may be justified where out-of-state goods or services are particularly likely to threaten the health and safety of a state's citizens and where outright prohibition, "rather than some intermediate form of regulation, is the only effective method of [protection]."(10)

Courts will sometimes look to the motivation underlying a law to determine whether the stated reasons for regulation are a pretext for economic protectionism. Further, regulations which impose unduly burdensome requirements on out-of-state residents may be invalidated under the Commerce Clause. A licensure procedure may not impose charges or expenses greater than reasonably necessary to defray the administrative cost involved nor may it impose residence or other requirements that make it impossible for out-of-state professionals to comply.(11)

Because telemedicine consultations affect the health and well-being of individuals physically located in the state, states arguably have a legitimate local interest in ensuring that out-of-state telemedicine health professionals meet the same standards as professionals licensed within the state. The extent to which a particular telemedicine statute imposes burdens on out-of-state providers and interstate trade would have to be weighed against the benefits of regulation and the reasons for the regulation.

Federal Authority

Despite the states' clear authority to license health care professionals, the Federal government does have the authority to establish national licensure standards. The Medicare and Medicaid programs, which include conditions of participation for nursing homes and other providers, establish specific standards of practice under their respective programs. In addition, Congress has previously passed laws establishing health and safety standards which affect interstate commerce. For example, Congress passed the Mammography Quality Standards Act (MQSA) of 1992, the Occupational Safety and Health Act of 1970, and the Clinical Laboratory Improvement Amendment of 1988. The Mammography Quality Standards Act allows the FDA to establish national standards for mammography facilities. States cannot mandate lesser mammography standards but can mandate standards that are stricter than those required under MQSA.

The Supremacy Clause of the Constitution preempts state laws that interfere with, or are contrary to, the laws of the Federal government.(12) But there is a strong presumption against preemption.(13) The Supreme Court has acknowledged that the regulation of health and safety matters has primarily and historically been a matter of exclusive state concern, and therefore preemption of state law should not occur in the absence of Congress' clear intent to supersede the state law(14). However, the Supremacy Clause mandates that even state regulation designed to protect vital state interests must give way to paramount Federal legislation.(15)

Congress' intent to preempt state law must be explicitly stated in the statute's language or implicitly contained in its structure and purpose.(16) In the absence of explicit pre-emptive language, courts have implied pre-emption in two situations. The first example exists where the scheme of Federal regulation is "so pervasive as to make reasonable the inference that Congress left no room for the states to supplement it."(17)The second example exists where "compliance with both Federal and state regulations is a physical impossibility"(18) or when the purposes behind the two regulations are inconsistent.

Should Congress desire to regulate telemedicine licensure, it could do so. States would be able to continue their own licensing systems in the absence of complete preemption and to the extent that the purpose of a state licensing scheme does not interfere with the purpose or methods by which the Federal statute is designed to reach its goal, states would be able to continue their own licensing systems. If Congress decided to completely appropriate licensure of the telemedicine industry for the Federal government, any state action in that area would likely fail no matter how well it agrees with the Federal action and policies. Thus, the ultimate question of preemption will lie with the intent of Congress.

Regional/Multi-State Authority

Under our Federal form of government, states are sovereign authorities that maintain those powers not ceded to the Federal government. The U.S. Constitution recognizes the states' authority to enter into compacts or agreements with one another subject to the consent of Congress.(19) "An interstate compact is an agreement between two or more states established for the purpose of remedying a particular problem of multi-state concern."(20) The interstate compact enables states to accomplish what they could not do alone because of lack of control over the entire subject matter or lack of resources. (See Box 13)(21) Interstate compacts have been used to settle jurisdictional issues, establish uniformity in the regulation of people or goods, determine rights to property, taxes or natural resources, and to establish formal cooperative arrangements between state agencies for the provision of services

In areas traditionally left to the Federal government, states must seek Congressional consent to a compact. A compact is enforceable as a contract and will supersede all other conflicting state statutes, whether enacted prior or subsequent to the compact. The compact may not be modified nor revoked without the consent of the member states.

Regional or multi-state solutions to facilitate the delivery of interstate medical services are currently being explored by the Western Governors Association, whose Telemedicine Action Report recommends the establishment of a task force to draft a "Uniform State Code for Telemedicine Licensure and Credentialing."

Standards

One of the primary functions of a licensure system is the establishment of academic and clinical competency standards for the practice of the profession. The licensure authority must ensure that those entering the profession are academically qualified, competent, and mentally and physically fit to provide the activities covered by the license. There has been some harmonization of standards and objective criteria, including educational and training requirements, for the practice of medicine among the states, but important differences remain.

In particular, the definition of the "practice of medicine" greatly varies from state to state, further compounding the question of what licensure actually permits or requires a clinician to do. These differences in these definitions and their dependent standards may impose difficulties on health professionals seeking to practice telemedicine across state lines. In addition to the need to become licensed in numerous jurisdictions, physicians and other health professionals may be subjected to inconsistent or conflicting disciplinary standards.

Enforcement

A licensure system must provide effective monitoring of the clinicians' competency and professional conduct, respond to the information brought to it by patients and health professionals, and provide a means to investigate and adjudicate complaints against a health professional. A licensure authority must have the means to hold the clinician accountable for his or her actions and enforce the authority's disciplinary decisions.

However, whether a state has the authority to enforce its licensure regulations against unlicensed out-of-state health professionals is unclear. For example, in the case of a physician practicing in a state where s/he does not hold a license, the physician's "home" state board may or may not take disciplinary action after a complaint is lodged. (See Box 14 )

The courts have not ruled on the issue of whether a state has jurisdiction over an out-of-state health professional offering telemedicine services to a patient located in that state. Before a state has the power to regulate an out-of-state health professional, the state must have legal jurisdiction over the person or entity(22). A person's presence in a state is not required for a state to have jurisdiction over him or her. For the purposes of telemedicine, the question of legal jurisdiction may turn on the extent to which an out-of-state clinician takes affirmative action to establish contacts in the state(23). For example, frequent transmissions into the patient's state and the solicitation of referrals from the state will likely be considered as evidence that the health professional is availing him or herself of the state's jurisdiction. Ultimately, the question of jurisdiction may require a balancing of how often and in what context the provider has conducted business in the jurisdiction.

Administration

In addition, a licensure system must be able to administer and enforce its standards. The system should efficiently issue licenses, monitor activities and enforce its standards without imposing unnecessary burdens on licensees or the public. In addition, the licensure and enforcement process should be consistent and fair.

States' requirements for licensure often differ between states. The process for any one license can be time consuming, as shown in the case of physician license requirements (See Box 15)

There are numerous procedural issues that must be addressed by any licensure authority. A few include: who determines whether an applicant is qualified to practice medicine--an individual or a board; what credentials must be presented; are initial applicants treated differently from those already licensed in another state; what due process protections are in place to ensure that licensees are given a fair opportunity to respond to disciplinary charges; and, what fees are necessary to administer the system and how will they be collected and distributed?

The latter issue is of particular concern to some states where licensure fees provide a significant contribution to state revenues. These concerns have further relevance in discussion of national or Federal licensure models that would not only redistribute authority but also could significantly redistribute revenues away from the states.(24) Clearly, the efficient administration of the licensure system is a difficult but critical task.

D. ALTERNATIVE APPROACHES TO LICENSURE

Most states require physicians to obtain a full and unrestricted license in order to offer medical services in that state. As noted above, a number of states have recently enacted licensure laws or regulations that explicitly affirm the requirement for a full license to practice in that state.

Currently there are a variety of alternative models relating to licensure that could be applied to a health professional providing only telemedicine services. A number of these models are available for review. Some of these models would vest partial or full authority to set standards and administer the licensure process in bodies other than the states. Some models would set uniform standards for credentials, professional conduct and discipline. Most models would provide specific mechanisms for enforcement proceedings against out-of-state health professionals. The following listing provides both a generally agreed upon working definition of the various terms related to licensure activities as well as a brief discussion and analysis.

Consulting Exceptions

Most state medical practice acts contain consultation exceptions to their licensure which allow a physician who is unlicensed in a particular state to practice medicine in that state at the behest 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. Regular or frequent consultation may require the out-of-state physician to obtain a license. State medical boards have not defined consultation by regulation and have instead applied the term on a case-by-case basis. While telemedicine consultations could arguably fall within many of these consultation exceptions, a number of states have interpreted their consultation exceptions to preclude the practice of telemedicine.

Consultation exceptions to the licensure laws were enacted in most states before the advent of telemedicine. Although they may be well-suited to some telemedicine situations, it is unlikely these exceptions were intended to apply to regular, on-going telemedicine links. State legislatures or medical boards could amend these exceptions to clarify under what circumstances they apply to telemedicine.

Endorsement

Licensure by endorsement is currently used by most state boards to grant licenses to health professionals licensed in other states that have equivalent standards. For example, many 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. At a minimum, health professionals seeking licensure by endorsement must submit an application, original transcripts, letters of recommendation and fees to the state board for review and approval. Each state retains separate disciplinary authority over its licensees. Endorsement allows states to retain their traditional power to set and enforce standards that best meet the needs of the local population. However, for multi-state health professionals, the burden of complying with diverse administrative requirements and standards of professional conduct may be time-consuming and expensive. To the extent that standards and procedures are harmonized, these burdens become less prohibitive.

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. This approach has been adopted by the European Community and Australia to enable the cross-border practice of medicine. 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 deemed essential to the health care system. The health professional secures a license in the home state and is not required to obtain additional licenses to practice in other states. The health professional must, however, inform the other states of his or her intent to practice therein. Mutual recognition requires the participating states to agree to a common harmonized set of standards governing qualifications, conduct and discipline. However, the process by which mutual recognition is administered could vary.

For example, if we examine the case of physicians, mutual recognition could allow registered physicians to engage in the full range of medical practice or limit practice to a defined scope, such as providing medical services via telecommunications only. Enforcement authority could be structured to enable the host to investigate and sanction a registered physician or the host could be limited to suspending the physician's right to practice in the host state pending disciplinary proceedings by the home state. Once a physician's license is revoked by one state, it might be revoked automatically in all other jurisdictions, or revocation could depend upon separate proceedings in each state.

These issues of standards, enforcement and administration would have to be negotiated in any mutual recognition system. Such negotiations likely would be time consuming and complicated. Over the years, states have established standards, administrative procedures and enforcement mechanisms suited to the particular needs of the local population. Whether states would be willing to accept higher or lower standards than they currently have is uncertain. This is one of the issues that groups like the Western Governors Association would need to address to develop a network approach to licensure.

Reciprocity

Reciprocity denotes the relationship between two states when each state gives the subjects of the other certain privileges, on the condition that its own subjects shall enjoy similar privileges at the hands of the latter state. 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 conducted on a bilateral or multilateral basis. A license valid in one state would give privileges to practice in all other states with which the home state has agreements.

No states are currently parties to a reciprocity agreement, although reciprocity arguably occurs now when patients physically travel to distant states to receive care. The process of negotiating bilateral or multilateral agreements between pairs or groups of states would be time consuming and complicated. Reciprocity does not require a harmonization of standards or procedures, thus leaving health professionals subject to diverse requirements. A regional approach to reciprocity could be an incremental step toward standardization of the licensure process.

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 therein. By so registering, the clinician would submit to the legal authority and jurisdiction of the other state. Health professionals would not be required to meet the entrance requirements imposed upon those licensed in the host state, but they would be held accountable for breaches of professional conduct in any state in which they are registered.

California has passed legislation that would authorize registration but has not yet implemented it. There are currently no other licensure systems utilizing registration. Issues which would have to be addressed under a registration system include the appropriate process for disciplining out-of-state health professionals, the administrative procedures for registration, and issues of professional conduct where standards vary from one state to the next, i.e. patient record-retention and confidentiality requirements. Registration should be less burdensome than current licensure requirements, but will affirmatively assert jurisdiction over out-of-state health professionals and make it easier to hold them liable for their conduct. Further, some protections may be necessary to guard against health professionals obtaining a license in the easiest jurisdiction with the lowest requirements and merely registering elsewhere.

Limited Licensure

A limited licensure system would be a modification of the current system. Health professionals would be required to obtain a license from each state in which they practiced. However, the health professional would have the option of obtaining a limited license that allows the delivery of a specific scope of health services under particular circumstances. This system would limit the scope of practice rather than the time period for practice as is currently the case with some consultation or emergency exceptions. The health professional would be required to maintain a full and unrestricted license in at least one state. Presumably, the administrative process for obtaining a limited license would be somewhat less burdensome than for full licensure. Each state would continue to establish its own standards for licensure.

Limited licensure requires each state legislature, acting on its own, to adopt such a system. Limited licensure could reduce the administrative burdens on out-of-state health professionals who would otherwise obtain a full license. Clinicians will continue to confront the hurdle of trying to comply with disparate state licensure requirements because each state would continue to establish its own standards for licensure.

National Licensure

A national licensure system could be implemented at the state or national level and would involve the issuance of a license based on a standardized set of criteria for the practice of health care throughout the U.S. Administration of this system at the national level could be left to a national professional organization. Central administration might raise concerns over state revenue loss, the legal authority of the states, the mechanism for financing the system, and the logistics of where and how confidential licensing data would be collected, processed, and stored. Disciplinary actions would continue to be carried out at the state level subject to the national standards.

If implemented at the state or local level these issues could be simplified, since states could retain control. In either case, these national standards would require states to agree on a common set of standards that encompass everything from qualifications to discipline.

Federal Licensure

Under a Federal licensure system, health professionals would be issued one license by the Federal government based upon Federally established standards related to qualifications and discipline. This license would be valid throughout the United States. These Federal regulations would preempt existing state licensure laws. A Federal licensure system could be administered through Federal agencies either at the national or local level, or through the states.

The establishment of uniform standards and procedures at the Federal level may ease the administrative burden on clinicians. However similar logistical and administrative problems would occur with the central administration of a Federal licensure system and enforcement activities carried out at the Federal level would likely be difficult.

Under these circumstances, states may be charged with implementing the system. This creates some questions noted above about how such a system would be funded and how administrative and disciplinary responsibilities would be paid for and carried out. Further implementation of Federal standards removes the states' traditional authority to set standards reflective of the demographics, practice patterns and procedural needs at the local level.

E.LEGAL AND REGULATORY ISSUES RAISED BY THESE MODELS

A major purpose of licensing health care professionals is to protect the public from those who are incompetent or impaired. To be effective, a licensure system must have the standards and resources to ensure that health professionals are clinically competent in their chosen specialty, as well as mentally and physically fit to render services to the public, identify impaired health professionals, resolve patient complaints, and prosecute health professional misconduct. The system must also provide due process guarantees for licensees and applicants. Not all licensure models are equally suited to accomplishing all of these tasks.

States would continue to play a primary or critical role in most of these models. Models that leave power to the states must rely upon voluntary state participation for their success.

In the case of physician licensure, state standards have been harmonized to some extent. (See Box 17 ) However, administrative procedures and some standards of professional conduct remain disparate. In fact, over the past two years, state laws governing interstate medical activity have become increasingly diverse as state legislatures enact different language to address concerns regarding telemedicine. Without an agreed-upon set of standards, there will continue to be disparate state medical practice acts and statutes. This lack of coordination presents difficulties for health professionals whose practice extends into many states. On a practical level, the difficulty in negotiating bilateral or multilateral agreements must be recognized.

At the same time, telemedicine may greatly increase the number of interstate consultations and the risk that patients will obtain services from individuals whose qualifications cannot be easily verified. Any changes in the licensure system should ensure that a "lowest common denominator" standard of health care is not developed that enables the least competent health professionals to simply relocate to the state with the lowest standards.

Models that formally grant licenses or recognize out-of-state health professionals will give states jurisdiction over out-of-state health professionals. While all of these models seek to hold health professionals accountable for their actions, the level of interest states will have in disciplining out-of-state health professionals who only occasionally see patients in the state is uncertain. Their disciplinary actions will certainly be influenced by the resources available to them. The concern over economic issues will continue to be a key factor as systems that eliminate fees from the issuance and renewal of multiple licenses may leave states with fewer resources to fulfill their administrative and disciplinary functions.

F.SPECIFIC REFORM PROPOSALS

A number of states and organizations are examining licensure alternatives for telemedicine. A few of the more widely-known models are outlined below.

California Registration Bill. On September 24, 1996, California enacted a law which gives the state medical board the discretion to develop a proposed registration program to permit out-of-state physicians to practice telemedicine in California(25). The proposed registration program is intended to be implemented by future legislation. The registration program would discipline health professionals who allow unregistered persons to practice telemedicine in California as well as discipline registrants who violate the licensure requirements of other jurisdictions. The registration program may include standards for confidentiality and format of medical records, registration fees and consumer education.

American College of Radiology. In 1994, the American College of Radiology (ACR) adopted a "Standard for Teleradiology" which includes the recommendation that "physicians who provide the official, authenticated interpretation of images transmitted by teleradiology should maintain licensure appropriate to delivery of radiologic service at both the transmitting and receiving sites." The ACR has developed a model act based on this standard which is similar to the current endorsement mechanism utilized by state licensure boards. In addition to licensure and credentialing, the ACR Standard provides for the appropriate storage of images, delegates responsibility for ensuring the quality of transmitted images, and establishes quality control and equipment standards for teleradiology.

American Medical Association. The American Medical Association (AMA) House of Delegates voted in June 1996 to adopt a policy that "states and their medical boards should require a full and unrestricted license for all physicians practicing telemedicine within a state." The policy went on to say that application requirements are to be "non-burdensome, issued in an expeditious manner, have fees no higher than necessary.....and that utilize principles of reciprocity with the licensure requirements of the state in which the physicians in question practice." The final resolution adopted by the AMA differed from that recommended by the Joint Report of the Councils on Medical Education and Medical Services which proposed that states should adopt a "special license" for telemedicine health professionals. The AMA also adopted a resolution calling for the Board of Trustees to "study the ethical and legal questions raised by new communications technologies as they relate to medical practice, including the worldwide web, teleconferencing, physician-staffed phone services that provide medical advice to nonpatients, and open physician discussions of clinical matters on online services."

College of American Pathologists. The CAP has taken the position that "a physician rendering primary diagnosis and/or treatment should have a full and unrestricted license to practice medicine in the state in which the patient presents for diagnosis. In cases where specimens, slides or images are transported in interstate commerce, the patient is deemed to have presented for diagnosis in the state in which the specimen is taken or the image made." Like the above models, this proposal would require physicians to have their license endorsed in each state from which they receive patient specimens or information. The CAP suggests that patients and the delivery of care would be better served through an abbreviated licensure process as opposed to a license for a limited practice.

Federation of State Medical Boards. In October 1995, the Federation of State Medical Boards (FSMB) proposed "An Act to Regulate the Practice of Medicine Across State Lines." This model act would require physicians who regularly or frequently engage in the practice of medicine across state lines, by electronic or other means, to obtain a special license issued by the state medical board. Practice across state lines is defined broadly as "the rendering of a written or otherwise documented medical opinion concerning the diagnosis or treatment of a patient." As with limited licensure, physicians holding a special license would be prohibited from physically practicing medicine within the state unless a full and unrestricted license were obtained. It would subject the licensee to the Medical Practice Act of the issuing state, and to the regulatory authority of the state's medical board. Each state would have the option of denying such a special license but would be encouraged to issue the license if it found that the applicant would not present a threat to the public. The Model Act would narrow the consultation exception to ad hoc consultations which are neither compensated nor performed under a contractual relationship.

National Council of State Boards of Nursing. The National Council of State Boards of Nursing (NCSBN) has been examining alternative licensure models for nurses that would facilitate the interstate movement of nurses as well as the practice of telemedicine. Among the models under consideration are a multi-state licensure system administered by the states and a centralized licensure system administered under state authority via a multi-state compact.

F. OTHER LEGAL ISSUES--PROFESSIONAL LIABILITY

Medical malpractice can be defined as professional misconduct in improperly discharging professional duties, or failing to meet the standard of care of a professional. Various definitions of standard of care and professional duties have been provided by statute, regulations, and case law. The diverse nature of these definitions and their sources are further complicated by jurisdictional issues when applied in the area of telemedicine. The additional problem of the time delay between the event leading to a malpractice claim and the filing of the claim means that some problems may take up to two or more years before they become apparent.

The Physician Insurers Association of America has concluded that malpractice claims require an average of 21 months following the alleged incidence of an adverse outcome to be reported. A number of basic questions will need to be addressed as telemedicine specific policy and procedures dealing with malpractice liability are formulated. Some of these have been raised in the preceding sections. Issues of choice of venue and law will need to be considered as states differ in their statutory limits on malpractice awards. This is certainly an issue in the development of a multi-state network system. Existing financial considerations affect both the individual health professional and the malpractice insurer.

The variety of types of services potentially deliverable through telemedicine will most likely require insurers to evaluate the need to develop new types of policies specifically for telemedicine based on the type of service being provided. Definitions will also have to be developed specifying what constitutes a physician-patient relationship under telemedicine. The specific definitions developed will have legal as well as quality of care implications. For example, the question of whether "distance medicine" imposes a new standard of care needs to be resolved. If face-to-face contact creates greater opportunity for better diagnosis and communication between patient and the practitioner, then the telemedicine practitioner might be more vulnerable to suit. The effect of telemedicine on the subsequent development of a therapeutic relationship is also not currently defined. The IOM Report states that "Decision makers still do not have good enough information comparing the effects of telemedicine applications to those of alternative health care strategies for quality, access, cost and acceptability."(26) Such information will be essential in the development of an acceptable liability system to deal with the unique issues raised by this technology.

G. NEXT STEPS

To date, most of the nation's telemedicine initiatives have occurred within states. This situation could rapidly change as the number and diversity of telemedicine services grow in many parts of the country where health care services do not follow geopolitical boundaries. Traditionally, patients go where the care is. As telemedicine is increasingly used to bring care to where the patient is, concerns about interstate licensure restrictions are bound to grow.

There are a variety of approaches to deal with the interstate licensure issues raised by telemedicine and although there appears to be substantial similarity among states with regard to the initial criteria required to obtain a license, significant differences persist. Currently these significant policy and procedural differences among states raise costly and time-consuming barriers for multi-state telemedicine providers seeking a license.

Although not strictly a legal issue, the related process of credentialing health care professionals has profound implications for telemedicine and has legal implications. "Credentialing" refers to the institutional (hospital, HMO) policy and procedures that determine whether a health care professional has the qualifications to be employed or be granted privileges to practice. This information is used in employment decisions, in granting clinical privileges and in the establishment of a practitioner's scope of practice (the range of services an individual may perform). This aspect of health professional regulation is not routinely conducted at the state or Federal level unless the professional is primarily employed by the Federal or state government. In some instances, however, state medical practice acts may specify requirements for credentialing. Traditionally the institutions in which the health professional is providing the service have taken this responsibility. Nationally accepted standards are provided by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the National Commission on Quality Assurance. Although intimately associated with licensure, the process of credentialing is a separate activity.

An unresolved issue is whether a telemedicine consultant needs to be credentialed at both his/ her home as well as at the remote institution for which attending health care professionals request consultation. If significant numbers of institutions are involved, a requirement for credentialing at each could create significant administrative burdens for both health care professionals and institutions. The JCAHO has no official policy, but it has issued one opinion stating that the consultant physician responding to a request for a referral does not have to be credentialed at the referring institution so long as the referring physician writes all orders that are in the patient's chart.

In the coming months, the JWGT will convene a group of interested parties, including representatives from the Federation of State Medical Boards, the National Council of State Boards of Nursing, the AMA, the Western Governors, the Center for Telemedicine Law, and National Governors Association, and the American Telemedicine Association, to explore next steps to ease licensure barriers between states.

In particular, the JWGT is very interested in stimulating the development of regional or multi-state licensure compacts that would provide models for future harmonization of licensure across the nation.

In addition, the JWGT will convene representatives from several health professional associations and credentialing bodies (e.g., specialty societies, the AMA, the American Nurses Association, Joint Commission on Accreditation of Health Care Organizations, and the American Psychological Association) to explore issues of credentialing of health care professionals in telemedicine.

H.LEGAL ISSUES REFERENCES AND NOTES

1. H.R. 1555; 104th Cong., 1st Sess. (1995). The amendment originally referred to "licensed health care provider" rather than "licensed physician."

2. S. 2171, 104th Cong., 2nd Sess. (1996).

3.See, Appendix 1 for the state statutes and regulations pertaining to telemedicine.

4. April 13, 1995 Letter from Florida Board of Medicine to President of Florida Society of Pathologists (first reviews of electronic images, biopsies and pathologic specimens are not considered consultations); March 18, 1996 Letter from Iowa Board of Medical Examiners to Ellen S. Weinstein (medical reports used for 'primary diagnostic purposes' do not fall within state's consultation exception); Minutes of November 9, 1993 Executive Session of Maine Board of Medical Examiners (primary physician performing radiologic study must be licensed in Maine); September 18, 1995 Letter from Massachusetts Board of Registration in Medicine to Harry L. Greene, M.D. and Kevin B. Dole, M.D. (reading of biopsies by out-of-state physicians constitutes the practice of medicine); March 29, 1996 Letter from Pennsylvania Board of Medicine to Teleimaging Chartered (out-of-state physicians "who routinely perform telemedical services resulting in medical reports or opinions" regarding patients in Pennsylvania must be licensed by state); and April 22, 1994 Minutes of Legislative Committee of Virginia Board of Medicine (out-of-state physician doing primary interpretation of a radiology image for patient located in Virginia must be licensed in state).

5. Letter from Office of the Attorney General of Mississippi to P. Doyle Bradshaw, Executive Officer of the State Board of Medical Licensure, December 8, 1995. 1995 Miss. AG LEXIS 867 (Dec. 8, 1995).

6.Goldfarb v. Virginia State Bar, 421 U.S. 773, 792 (1975); see, also, Ferguson v. Skrupa, 372 U.S. 726, 731 (1963); Dent v. West Virginia, 129 U.S. 114, 122 (1889).

7. "The Commerce Clause of the Constitution grants Congress the power '[to] regulate Commerce with foreign Nations, and among the several states, and with the Indian Tribes.' Art. I, 8, cl. 3. 'Although the Clause thus speaks in terms of powers bestowed upon Congress, the Court has long recognized that it also limits the power of the states to erect barriers against interstate trade.'" Maine v. Taylor, 477 U.S. 131, 137 (1986) (quoting Lewis v. BT Investment Managers, 447 U.S. 27, 35 (1980)).

8.See, e.g., Arizona v. Maricopa County Medical Soc'y., 457 U.S. 332 (1982).

9. Maine v. Taylor, 477 U.S. 131. (Maine was allowed to prohibit import of baitfish in order to protect the health and integrity of native species. The Supreme Court found that no alternative, non-discriminatory means would achieve the state's legitimate objectives.)

10Maine v Taylor, 477 U.S. at 150 (quoting Lewis v BT Investment Managers, Inc., 447 U.S. 27, 43 (1980)).

11. Mercer v. Hemmings, supra.

12.U.S. Const. Art. VI, cl.2. The Supremacy clause states: "This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding."

13.The Supreme Court first recognized the Federal-state balance in McCulloch v. Maryland, 14 U.S. (4 Wheat.) 316, 427 (1819). Since that time, "it has been settled" that the doctrine of preemption constitutes the resolution between Federal and state law, and all "state law that conflicts with Federal law is without effect." Cipollone v. Liggett Group, 505 U.S. 504, 516 (1992) (quoting Maryland v. Louisiana, 451 U.S. 725, 746 (1981)).

14.Fort Halifax Packing Co. v. Coyne, 482 U.S. 1, 21 (1987).

15.De Canas v. Bica, 424 U.S. 351, 357 (1976).

16.Cipollone v. Liggett Group, 505 U.S. at 516. The Supreme Court held in Jones v. Rath Packing Co., 430 U.S. 519, 525-26 (1977), that preemption depends upon "the relationship between states and Federal laws as they are interpreted and applied, not merely as they are written;" 375 U.S. 96 103 (1963); Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977); see also Ingersoll-Rand Co. V. McClendon, 498 U.S. 133, 138 (1990) (slip op., at 3) (stating that "[t]o discern Congress' intent we examine the explicit statutory language and the structure and purpose of the statute.").

17. Jones v. Rath Packing Co., 430 U.S. at 525 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)); see also Fidelity Fed. Sav. & Loan Ass'n. v. De La Cuesta, 458 U.S. 141, 153 (1982).

18.Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963); see also, McDermott v. Wisconsin, 228 U.S. 115 (1913). (Wisconsin's syrup-labeling rules were such that if out-of-state syrup was labeled so as to comply with the Federal Food and Drugs Act, they syrup would be mislabeled under Wisconsin law. The Court barred enforcement of the Wisconsin regulations.)

19.U.S. Const. Art. I, Sec. 10, cl. 3, provides in pertinent part, "No State shall, without the Consent of Congress . . . enter into any Agreement or Compact with another State . . ."

20.Black's Law Dictionary.

Note: The Supreme Court has opened the door to states having authority over commercial activity outside its borders. For example, the court has held that a state's regulatory jurisdiction could be asserted on the basis of contacts with the state through the mail. A state may argue that its interest in protecting its citizens justifies the imposition of regulations over out-of-state telemedicine providers even though there may be a low level of contacts with the state. In other situations where a party's only contact with the state has been by electronic transmission, courts have reached conflicting conclusions on the issue of jurisdiction.

21.Zimmerman and Wendell, The Law and Use of Interstate Compacts, 1976.

22.A state may have jurisdiction over a defendant so as to require it to defend itself in that state, while at the same time not having jurisdiction over the defendant to regulate them. See generally, Quill Corp. v. North Dakota, 504 U.S. 298, 320-321 (1992).

23.It has been held that the type of contacts required for regulatory jurisdiction require "the connection between a state and the regulated person be of a more substantial character than the 'minimum contacts' needed to support judicial process running against the person." Aldens v. La Follette, 552 F.2d 745, 751 (7th Cir. 1977). On the other hand, it has also been held that "contacts that would justify regulatory provisions as to one type of business might not as to another because of the greater interest of the state in the former than in the latter." National Liberty Life Ins. Co. v. State, 62 Wis.2d 347, 215 N.W.2d 26 (1974).

24.Hutcherson, Carolyn. (Personal communication, September 19, 1996)

25. 1995 California S.B. 2098, signed by the Governor September 24, 1996.


FOOTNOTES

1. H.R. 1555; 104th Cong., 1st Sess. (1995). The amendment originally referred to "licensed health care provider" rather than "licensed physician."

2. S. 2171, 104th Cong., 2nd Sess. (1996).

3. See, Appendix D for the state statutes and regulations pertaining to telemedicine.

4. See Legal Issues References and Notes.

5. See Legal Issues References and Notes.

6. Goldfarb v. Virginia State Bar, 421 U.S. 773, 792 (1975); see, also, Ferguson v. Skrupa, 372 U.S. 726, 731 (1963); Dent v. West Virginia, 129 U.S. 114, 122 (1889).

7. See Legal Issues References and Notes.

8. See, e.g., Arizona v. Maricopa County Medical Soc'y., 457 U.S. 332 (1982).

9. Maine v. Taylor, 477 U.S. 131.

10. Maine v Taylor, 477 U.S. at 150.

11. Mercer vs. Hemmings, supra.

12. U.S. Constitution Art. VI, cl.2. (See References and Notes)

13. See Legal Issues References and Notes.

14. Fort Halifax Packing Co. v. Coyne, 482 U.S. 1,21 (1987)

15. De Canas v. Bica, 424 U.S. 351,357 (1976)

16. Cipollone v. Leggett Group, 505 U.S. at 516.

17. Jones v. Rath Packing Co.,430 U.S. at 525

18. Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963)

19. U.S. Const. Art. I, Sec. 10, cl. 3, provides in pertinent part, "No State shall, without the Consent of Congress . . . enter into any Agreement or Compact with another State . . ."

20. Black's Law Dictionary.

21. Zimmerman and Wendell, The Law and Use of Interstate Compacts, 1976.

22. See Legal Issues References and Notes

23. Ibid

24. Hutcherson, Carolyn (Personal communication, Sept 19, 1996)

25. 1995 California S.B. 2098, signed by the Governor, September 24, 1996. (See Appendix D)

26. Institute of Medicine: "Telemedicine:A Guide to Assessing Telecommunications in Health Care", 1996.