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Document 17 of 60.

March 21, 2000, Tuesday

SECTION: PREPARED TESTIMONY

LENGTH: 1859 words

HEADLINE: PREPARED STATEMENT OF BRUCE A. LEVY, MD, JD EXECUTIVE DIRECTOR TEXAS STATE BOARD OF MEDICAL EXAMINERS THE FEDERATION OF STATE MEDICAL BOARDS

BEFORE THE SENATE COMMITTEE ON HEALTH, EDUCATION, LABOR & PENSIONS

SUBJECT - HEARING ON E-DRUGS: WHO REGULATES INTERNET PHARMACIES?

BODY:
Good morning Mr. Chairman and members of the Committee. I am Dr. Bruce Levy, Executive Director of the Texas State Board of Medical Examiners. I am here this morning representing the Federation of State Medical Boards of the United States.

The Federation is a national non-profit association established in 1912, which serves as a collective voice for 68 member state medical licensing and disciplinary boards. The Federation's primary mission is to improve the quality, safety, and integrity of health care by promoting high standards for physician licensure and practice, as well as supporting and assisting state medical boards in the protection of the public. The Federation is uniquely positioned as an authoritative leader in policy development and dissemination relating to emerging issues affecting state regulation of the practice of medicine.

Enforcing the Law

The Federation strongly supports state-based regulation of the practice of medicine. With regard to Internet prescribing, state medical boards clearly have the authority to discipline licensed physicians prescribing and dispensing medications inappropriately. Several boards have already taken actions against such licensees, passed rules or introduced legislation to clarify this authority. In addition, state medical boards are beginning to communicate among themselves regarding physicians licensed in more than one state. These cooperative efforts have been effective in closing several Internet sites and causing a number of physicians to cease their affiliation with questionable operations. At least twelve (12) states have taken action against physicians for prescribing violations (CA, CO, FL, HI, IL, MI, MO, NV, OH, WA, WI, WY). In addition, at least nine (9) states have adopted rules or statements which clarify standards for online prescription and distribution of medications (AL, CA, FL, MD, MO, NV, NC, OH, TX). Legislation has been introduced in five (5) states (AZ, CA, FL, KS, VA) to establish practice standards for prescribing medications over the Internet. The Federation has played an active role in facilitating communication among the state medical boards and assisting them with information about activities in other states and at the federal level. The diffusion of administrative and legislative actions on the part of state medical boards will continue and will accelerate as more boards experience successful regulation efforts.

Special Committee on Professional Conduct and Ethics

Recently, the Federation has paid particularly close attention to the increased use of the Internet for the prescribing and distribution of medications, focusing on proper physician conduct in that context. Promoting a minimum standard of practice related to prescribing medications by electronic and other means is addressed in a recent report from the Federation's Special Committee on Professional Conduct and Ethics. The Special Committee studied the regulatory challenges presented by the increasing use of electronic communication in the practice of medicine, including prescribing and dispensing medications via the Internet. The Committee's report is expected to be approved by the Federation House of Delegates at its annual meeting next month.

Committee deliberations proceeded on the premise that accepted standards of medical practice must be upheld regardless of the means of communication or delivery of health care services. The Committee recognized that the Internet allows the delivery of health care services easily across state boundaries, which creates a need for cooperation and consistency in regulation among state medical boards and other federal and state regulatory agencies. The Special Committee Report recommends that state medical boards consider it unprofessional conduct by a physician, subject to disciplinary action to provide treatment recommendations, including issuing a prescription, via electronic or other means, unless the physician has performed a history and physical evaluation of the patient adequate to establish diagnoses and identify underlying conditions and/or contra-indications to the treatment recommended/provided. The report recognizes that exceptions to this general rule should be made in emergency circumstances, in on-call and coverage situations, for appropriate consultations when medical records are readily available and in the case of ongoing care for a patient with whom the physician has an existing relationship.

The report also recommends that state medical boards require licensees to disclose whether any portion of their practice is web- based and provide all related web site(s); establish that web sites providing medical services are practice locations and require that changes in web addresses be reported to the board; require physicians to disclose identifying information in their web site, including their name, practice location, states licensed and financial interests in any products prescribed or recommended; and require boards to take steps to educate licensees as to the appropriate use of the Internet in medical practice.

Clearinghouse

To address another aspect of the potential problems associated with the use of the Internet in the practice of medicine, the Federation's Board of Directors has approved plans to establish a clearinghouse for information regarding the operation of questionable Internet sites that could be accessed by all medical licensing boards if commitments of financial support are garnered from outside sources. We hope to have funding in place and the clearinghouse in operation before the end of the year. This effort will facilitate cooperation among regulatory entities having authority under current law to prosecute questionable web sites. Long Term Activities

The Federation assumed a leadership role in addressing medical regulation within emerging technological advances in the delivery of health care services in 1996 when it adopted A Model Act to Regulate the Practice of Medicine Across State Lines. The Model Act recommended reducing regulatory barriers to the advancement of telemedicine through creation of a special purpose license for physicians providing intrastate medical services. The special purpose license also guaranteed patients' protection by their home-state medical board.

As medical-related web sites multiplied on the Internet, the Federation again recognized the threat to public safety posed by web sites prescribing and dispensing medications based on information gathered on an electronic questionnaire. At the same time, state medical boards were facing the challenge of regulating these activities due to the difficulty of identifying the physicians involved and where they are licensed. Early this year in response to these issues, the Federation invited officials representing government, medical and private sector entities to meet in Washington D.C. to discuss potential solutions to the regulatory complexities related to prescribing and dispensing medications using the Internet.

The Federation initiated the meeting because of its concern about the need for leadership in coordinating a collaborative regulatory approach to this very complicated and potentially dangerous issue.

The January meeting generated a firm commitment on the part of the participants to share information and work together toward a coordinated mechanism for identification and prosecution of individuals associated with questionable medical-related Internet activities. Participants agreed that consumer education is important, but should be accompanied by aggressive enforcement of current statutes and regulations relating to medical and pharmaceutical practice. The meeting resulted in four (4) specific proposals, which have been endorsed by the Federation's Board of Directors:

1) The Federation will encourage state medical boards to adopt a minimum standard of practice related to prescribing medications utilizing the Internet or other remote means.

2) The Federation will explore the feasibility of establishing a clearinghouse to assure the timely and appropriate dissemination of information regarding participants in and operation of questionable Internet sites that market and provide prescription medications to consumers if external sources of financial support for such efforts can be identified.

3) The Federation will develop an algorithm of jurisdiction and authority of the various federal and state regulatory agencies responsible for the oversight of the various components of Internet sites offering health care services. This information will be distributed to the regulatory authorities to assist in referring and cooperating in actions against questionable web sites, their operators and affiliated practitioners.

4) The participating parties will work together in identifying egregious cases for referral to the Department of Justice for prosecution. Prosecution will serve as a deterrent for physicians and pharmacists considering participating in questionable web sites.

While states are moving forward with successful efforts to enforce regulation of online prescribing, the Federation feels that the most appropriate involvement of the Federal government is in the area of aggressive enforcement. The experience of state medical boards in this area has proven that enforcement can be a powerful tool in dissuading new Internet operations and discouraging continuation of existing operations. Operators and the physicians associated with many of these web sites are entrepreneurs who are motivated by financial gain, but in most cases they are unwilling to jeopardize their professional credentials when challenged by regulatory authorities. Enforcement efforts by the Department of Justice or other Federal authorities will attract national attention and serve as a major deterrent to participation in questionable Internet operations. Enforcement efforts by the states, while effective, do not generate such national coverage.

In order to protect consumers, a collaborative effort will be necessary. It appears that current laws are adequate, but strict and aggressive enforcement must be encouraged.

It is imperative that efforts continue to identify bad actors, both pharmacy operators and the associated physicians, and that their identity be shared among state and federal regulatory authorities.

Involvement of the private sector is also necessary to protect the legitimate operators. The medical and pharmacy professions must join together to educate consumers and develop and promulgate standards of professional practice.

The Federation believes that current laws are adequate for enforcement and regulation of online prescribing. Through continued cooperation among industry, government, health care organizations and consumer groups in identifying problems and solutions, the public can benefit from the convenience and accessibility of Internet commerce, while also enjoying the protections afforded by appropriate regulation.

Thank you again for the opportunity to appear before the Committee today on behalf of the Federation of State Medical Boards.

END

LOAD-DATE: March 23, 2000

Document 17 of 60.


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