INTRODUCTION
The Internet promises to transform the way the practice of medicine is conducted in the new millennium. State medical boards, as the administrative bodies responsible for overseeing the practice of medicine, are struggling to find ways to ensure that unscrupulous and unsafe practitioners operating online do not harm those living within their jurisdictions. This article examines the impact the Internet has on the ability of state medical boards to regulate the practice of medicine, responses at the state and federal level to these technological developments, and proposals which balance the benefits of technological advances with the ability to reasonably protect health care consumers.
AUTHORITY, ASSISTANCE, AND A NEW CHALLENGE
More than a century ago, the Supreme Court confirmed the right of states to regulate medical practice.1 The court’s decision was rooted, in part, in the belief that the general public is unable to assess effectively the qualifications and competence of individual physicians.2 According to the court, “Every one may have occasion to consult [a physician], but comparatively few can judge of the qualifications of learning and skill which he possesses. Reliance must be placed upon the assurance given by his license, issued by an authority competent to judge in that respect, that he possesses the requisite qualifications.”3 The case also explicitly describes how the police powers to protect the health and welfare of state denizens,4 and the nature of the medical profession at that time, granted states the authority to establish individualized licensure standards.5 While regional variation persists in physician practice patterns,6 the general standards for medical licensure in any particular state, thanks in part to the efforts of the Federation of State Medical Boards,7 are practically uniform nationwide.
The advent of the Internet has helped narrow the information gap between many patients and practitioners, and the flexibility and capabilities of computer technology offer seemingly limitless possibilities for improving and transforming health service delivery.8 Currently, most Internet users limit their Internet health care-related activities to the pursuit of general health-related information. While this information may be specific to a particular ailment or treatment modality, and may be written by a physician licensed in a different state from the residence of the Internet user, such information is generally not considered so specific as to constitute the practice of medicine. Some Internet users are now taking advantage of programs, run by prominent institutions such as Harvard Medical School and the Cleveland Clinic, which offer comprehensive virtual second opinions, a practice that hovers somewhere between the informational and the diagnostic.9 Some physicians have created primary care practices that rely heavily on telephone and electronic communication following an initial face-to-face consultation (with future office visits – and even house calls – conducted if needed).10 However, an increasing number of Internet users in the United States have moved beyond the pursuit of “cyber-assistance”11 and second opinions. These consumers seek services widely considered to constitute the practice of medicine, including patient-specific medical consultations and prescriptions.12 A growing number of physicians appear willing to meet this demand by providing services online, often without having developed a prior physician-patient relationship, having taken a thorough medical history or physical examination, and often without having fulfilled the licensure requirements of the states in which the consumers reside.13
State medical boards, facing record budget deficits and overwhelming caseloads,14 are struggling to find effective means through which to address the public safety concerns raised by remote practitioners unimpeded by state borders and unconcerned with local standards of practice. At the same time, state medical boards should contemplate whether greater interstate collaboration and federal intervention in the regulation of Internet medical practice may be necessary to effectively balance the interests of encouraging technological advances in health service delivery while protecting the public from fraudulent and substandard online practice.
LICENSURE AND REGULATION OF ONLINE MEDICAL PRACTICE
With the publication of its policy document Model Act to Regulate the Practice of Medicine Across State Lines15 in 1996, the Federation of State Medical Boards attempted to craft a middle way that would balance these competing interests. The Federation policy document recommended that, instead of requiring that online practitioners hold full and unrestricted licenses in the state in which the patient resides, states create a new special license, with an expedited application and approval process, specifically for these physicians.
However, many concerns were raised about the limitations of current technology to adequately provide both the information necessary to make diagnoses, treatment recommendations and prescribe medications, and the safeguards necessary to protect physicians and patients from fraud. These concerns were most compellingly represented in the position of the American Medical Association (AMA), which criticized online medical practice as a means of delivering primary health care services for its inability to replicate the richness and thoroughness of a face-to-face physician-patient interaction. In 1999, the AMA set forth the following five reasons as to why an online physician-patient interaction, resulting in a prescription or treatment, falls short of generally accepted standards for medical practice:
There are no examinations of the patient to determine if there is a medical problem and determine a specific diagnosis.
There is no dialogue with the patient to discuss treatment alternatives and to determine the best course of treatment.
There is no attempt to establish a reliable medical history.
There is no provision of information about the benefits and risks of the prescribed medication.
There is no follow-up to assess the therapeutic outcome.16
While compliance with these standards may vary (and sometimes be found lacking) in face-to-face physician-patient interactions, there is a higher likelihood that these goals will be met when a local patient interacts with a local provider.
In 2003, the AMA offered further guidance on Internet prescribing.17 According to the AMA, “physicians should adhere to any regulatory requirements of their individual state medical boards,” and if prescribing via the Internet, must have previously performed a physical examination of the patient “adequate to establish the diagnosis for which the drug is being prescribed and to identify underlying conditions and/or contraindications to the treatment recommended/provided.”18 Furthermore, the AMA believes the physician should generally possess the type of license required to practice as outlined in the licensure laws of the state in which the patient resides. The report offered an exception to this licensure requirement for treatments rendered in consultation with another physician who has an ongoing relationship with the patient. Furthermore, the report did not address the burgeoning practice of “fee-based online consultations.” In its 2003 guidance, the AMA also recognized the limitations and challenges posed by current technology in confirming the true identity of both patient and physician online, a concern best captured by a famous cartoon, in which a dog at a computer says to another dog sitting on the floor: “On the Internet, no one knows you’re a dog.”19
Later Federation publications reflected the AMA’s more comprehensive standard for what constitutes acceptable online practice. In 2002, the Federation stated that “A documented patient evaluation, including history and physical evaluation adequate to establish diagnoses and identify underlying conditions and/or contra-indications to the treatment recommended/provided, must be obtained prior to providing treatment, including issuing prescriptions, electronically or otherwise.”20
An alternative approach to licensure has been employed to allow greater flexibility in licensure and mobility for nurses.21 So far, 20 states have adopted the Nurse Licensure Compact, a mutual recognition licensure system developed and promoted by the National Council of State Boards of Nursing.22 Nurses working in states that adopt this compact can practice on patients (either online or in person) in any state that has adopted the Nurse Compact. The Nurses are subject to the laws of both the state in which they are licensed and the state in which they practice, and regulatory efforts are coordinated through the use of a centralized interstate database and a comprehensive communication network known as NurSys. This system acknowledges the reality that baseline practice standards are similar nationwide, and balances concerns with improving access to care with the ability to maintain both high standards for licensure, and accountability of the licensees to maintain the requisite level of practice standards. Thus far, for political and economic reasons, physicians appear less willing to contemplate such a system for their state licensure boards.
Had either the Federation’s Model Act or the Nurse Compact been adopted universally by states for use by their medical boards, there would have been an opportunity to both standardize licensure requirements nationwide and to foster greater practitioner mobility and the growth of online medical practice. However, states were almost uniformly unwilling to relax control over their local licensure process, instead following the guidance of the AMA (and their local state medical societies). Most states require those engaging in online practice to hold full and unrestricted licenses both in their home state and in the state in which the patient resides. Those states that passed the Model Act in some form took advantage of language contained therein, which allowed for modification of the statute to better reflect local medical practice standards.23 These unique local requirements eliminated the benefits of the special license status through the adoption of significant impediments to engagement in true remote medical practice: for example, all but two states which offer a Special Purpose License for Telemedicine require that the physician first conduct a physical examination prior to prescribing.
Approximately half of all states have taken action against local and out-of-state Internet providers for inappropriate medical practice online. Actions against in-state and out-of state providers may take a number of different forms, including cease and desist requests, disciplinary action and/or fines for violation of state prescribing and telemedicine licensure rules, and fraud.24 Online practitioners are appealing targets for state disciplinary boards. Cases against online practitioners require fewer resources (such as extensive use of investigators and expert witnesses) and may be prosecuted more rapidly than a typical substandard care case. Furthermore, at a time when state boards are perpetually falling under close scrutiny from legislatures and the media for their disciplinary activity level, a high profile case brought against a physician practicing online sends the message that state medical boards are taking rapid, decisive and proactive action to protect the public.
Significant questions remain about whether state licensing boards have jurisdiction over out-of-state practitioners offering Internet services to their residents; however, this has not prevented states from pursuing and prosecuting remote doctors, sometimes in spectacular fashion. In 2003, the Medical Board of California brought action against six out-of-state physicians for improper online prescribing practices.25 Under a recently adopted California law, online practitioners who fail to conduct a good faith medical examination indicating the need for the medication or treatment prescribed prior to providing such services are subject to fines of up to $25,000 per infraction.26 The six physicians had written nearly 2000 prescriptions between them, leading to a total of $48 million in fines levied against them. The California board also took the prudent step of alerting the practitioners’ home state medical boards of their licensees’ questionable conduct, in the hope that their home states would take action against their licenses. This is a critical measure, as the law remains unsettled as to whether a state in which a physician has no license has jurisdiction over an Internet practitioner whose only contact with their state is through a patient actively pursuing health services online.27 While greater interstate cooperation may enhance the likelihood of prosecuting U.S.-based online practitioners, absent enthusiastic and universal commitment by state medical boards to such collaboration, some practitioners may continue to be able to engage in improper medical practice across state lines, and others who may be located offshore may remain altogether beyond the reach of state regulators.
IS THE TIME RIGHT FOR A FEDERAL APPROACH?
So how can states maximize the flexibility for health service delivery available via the Internet, while at the same time protect their residents from unscrupulous providers? It is unlikely that state medical boards, acting as individual entities, can check the growing wave of providers willing to engage in medical practice online: the appeal of independence, financial reward and the ever-growing demand for such services almost guarantee that online health service delivery is here to stay. Because of the limited reach and resources of state boards, increased cooperation between state and federal regulators – and the ceding of some primary authority by states to protect the public’s health and welfare from elusive out-of-state and international online providers – is likely. This approach has been considered by a number of federal authorities, including the White House,28 Congress,29 the Food and Drug Administration (FDA),30 the Federal Trade Commission,31 and the Department of Justice.32
On the legislative side, Congress has demonstrated a willingness to enter into traditionally state-based issues pertaining to health service delivery when problems of a national or international scope arise.33 During the 108th Congress, federal tort reform legislation nearly became a reality. Congress justified its intervention into this traditionally state-based concern by finding that “the health care and insurance industries are industries affecting interstate commerce and the health care liability litigation systems existing throughout the United States are activities that affect interstate commerce by contributing to the high costs of health care and premiums for health care liability insurance purchased by health care system providers.”34 A similar interstate commerce argument could be made to justify Congressional intervention into the field of professional regulation.
Congress has already demonstrated its willingness to intervene in such matters in its recent attempts to address the issue of pharmaceutical importation. In 2000, Congress passed the Medicine Equity and Drug Safety Act,35 which granted the secretary of Health and Human Services the power to create regulations permitting pharmacists and wholesalers to import pharmaceuticals into the United States;36 however, this power has gone unused as the secretary has not been willing to certify that these imports “pose no additional risk to the public’s health and safety” and would “result in a significant reduction in the cost of covered products to the American consumer.”37 In 2003, Congress considered two significant changes to this regulation that would make prescription drug importation a reality. One would eliminate the secretary’s discretionary power and require that the secretary adopt regulations allowing for the importation of prescription drugs within 180 days of the legislation’s enactment.38 A second proposal would allow international collaboration by permitting “[a]ny establishment within Canada engaged in the distribution of a prescription drug that is imported or offered for importation into the United States [to] register with the secretary the name and place of business of the establishment and the name of the United States agent for the establishment.”39
Congress has also contemplated the preemption of state licensure laws in an effort to improve nationwide adoption of telemedicine services. The Comprehensive Telehealth Act of 199940 proposed a study of state telemedicine licensure policies and usage by the Secretary of Health and Human Services, and stated “[i]f...the Secretary determines that States are not making progress in facilitating the provision of telehealth services across State lines by eliminating unnecessary requirements, adopting reciprocal licensing arrangements for telehealth services, implementing uniform requirements for telehealth licensure, or other means, the Secretary shall include in the report recommendations concerning the scope and nature of federal actions required to reduce licensure as a barrier to the interstate provision of telehealth services.”41
Close collaboration is already under way in the related field of policing of online pharmacies and U.S.-based branches of Canadian “storefront” operations which ship and/or import prescription drugs from abroad. Like state medical boards, pharmacy boards have attempted to offer the public and their licensees guidance on proper pharmacy practice via the Internet. In 1999, the National Association of Boards of Pharmacy (NABP) enacted the Verified Internet Pharmacy Practice Sites (VIPPS) program, which offers certification for online U.S.-based pharmacies that meet stringent practice standards. This certification serves as a seal of quality that consumers can rely upon when making online purchases of their medications. However, the authority of the NAPB cannot reach deeply into the World Wide Web; consequently, VIPPS certification is only available for U.S.-based online pharmacies. In late 2002, Canada’s National Association of Pharmacy Regulatory Authorities adopted a similar program. However, this certification will help reinforce the status quo, rather than foster greater international cooperation to improve access to affordable quality health services, as the Canadian organization states directly “any Internet pharmacy that dispenses prescriptions for cross-border shipment into the United States will be denied the VIPPS Canada certification.”42 The enormous rise in non-VIPPS certified sites and U.S. consumers willing to utilize them demonstrates that such measures, while mindful of the public’s health and safety, are insufficient both to protect the public from unsafe providers and to induce providers to enroll in such public safety programs. Both an increase in public education on the public safety aspects of the current Internet pharmacy market and the benefits of the registration program, and a policy more open to the nature of the current health service delivery and Internet marketplaces, are likely necessary.
On the administrative side, federal agencies such as the FDA, the Drug Enforcement Administration, the U.S. Bureau of Customs and the U.S. Postal Service have worked together with state pharmacy boards to attempt to stem the flow of pharmaceuticals across the U.S. border. They are having limited success in this endeavor,43 and finding that regulating Internet pharmacies can be “like trying to nail Jell-O to the wall.”44
These efforts largely have been directed toward stopping suppliers of these services – the pharmacies and U.S.-based storefront operators – rather than the purchasers and the physicians who are writing or cosigning the U.S. consumers’ prescriptions. For example, while state pharmacy boards have had limited success in closing down Canadian pharmaceutical importation storefronts within their own states, the FDA recently filed a complaint for injunction45 against a national chain of storefronts under the Federal Food, Drug and Cosmetic Act.46 Furthermore, the FDA has indicated it would not sue cities and states that set up drug importation programs; however, they also wished to make clear this concession is not an indication of diminishment in the agency’s pursuit of the suppliers of imported and reimported medications.47 However, in spite of the fact that the learned intermediary physicians may be involved in the process of circumventing state and federal rules pertaining to prescriptions, pharmacies and U.S. based storefront importers appear to be garnering far more attention from these federal agencies than the physicians who may be providing the associated diagnoses and prescriptions.
There are compelling reasons for regulators to move now to create a national, if not an international, system through which to license and regulate Internet practitioners. The Internet can offer opportunities for improving access to primary and specialty care for a wide range of populations, such as the rural and urban underserved and the aged. Internet-based monitoring systems can help the chronically ill better manage their diseases. As Congress and state legislatures attempt to plan for the financial strain of adding 70 million Baby Boomers to such federal and state benefit programs as Social Security, Medicare and Medicaid, a national Internet provider system will offer an appealing medium through which to create larger economies of scale and greater efficiencies within the health service delivery market.
The political time is right for Congress to step in to create a standardized system for regulating online health practitioners nationwide. As mentioned earlier, the federal government, in its tort reform effort, has demonstrated its willingness to step into traditionally state-based health service delivery concerns. Furthermore, with states facing historic budget crises, Congress could use the power of the purse – holding out funding for related services via conditional block grant mechanisms – to persuade states to adopt uniform licensure and disciplinary rules.
All realistic options to effectively and flexibly manage online practice require that states cede some of their power to regulate health care providers. States have too many financial and legal limitations to adequately control the flourishing national and global market in Internet medical service. A number of different options may be available to protect public safety in this environment, from an international registration program, to an exclusively federal system, to a program creating federal licensure standards to be enforced by state boards, to universal adoption by states of a Model Act for Internet licensure.48 Another option would be to bring together all the stakeholders (providers, patients, technology companies, state and federal regulators) to develop a quasi-governmental supervisory and certification organization for Internet practitioners and health web sites, such as Medicare-eligible hospitals and HMOs possess in the Joint Commission on Accreditation for Healthcare Organizations.49 As it will likely be impossible to completely contain Internet practice, any adopted system will require extensive and ongoing public education efforts. Ideally, the great effort to create a uniform national system for Internet medicine practice will arise out of a collaborative effort between state boards and legislatures, the federal government, and international bodies,50 be flexible in its approach to online regulation (as we can never be sure what tomorrow’s technological innovations may bring), and let providers and patients have the opportunity to make the most of the innumerable benefits offered by a technology-powered health care system fashioned for the 21st Century.
References
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