President's Message

Florida Board of Medicine Emergency Rule 64B8ER00-1

Moratorium on Level III Office Based Surgery

A. Allen Seals, M.D., President

At the August 4, 2000 meeting the Florida Board of Medicine took the position that there is an "immediate danger to the health, safety, and welfare of patients in this state". The Board passed an emergency action rule which states, "Effective upon the filing of this emergency rule, there shall be a moratorium on all Level III surgeries, as defined in Rule 64B8-9.009, Florida Administrative Code, in any physician office…" The Board is enforcing the moratorium for a period of up to 90 days during which time further review of level III office based surgical procedures will be conducted. Florida physicians not directly affected by this rule, and who do not closely follow the actions of the Board may wonder: how did the Board reach this decision, and what are the opposing viewpoints?

Florida Board of Medicine Position: The Board has statutory authority to set standards of practice in various medical settings. During recent years, the practice of physicians performing surgery in their offices, rather than in hospitals or ambulatory surgery centers, has expanded both in numbers of surgeries and the complexity and duration of the surgical services being provided. As the Board and the public have become increasingly aware of the risks and adverse results of some office surgeries, through anecdotal evidence, such as individual disciplinary cases, the Board decided to evaluate the situation and to adopt standard of practice rules necessary to limit the likelihood of adverse incidents arising from surgeries in physicians offices. To this end, the Board adopted rules relating to office surgery in 1994. The Board and its committees have held hearings over the past two years and have developed additional standard of practice rules and rule amendments to try to increase patient safety. Some of the rule proposals, which the Board developed, have been adopted and others are pending and unable to be adopted because of legal challenges. On a collateral track, the Board successfully sought legislative authority to require physicians to report adverse incidents that occur in physician offices. The rules implementing that legislation, Section 458.351 Florida Statutes only took effect in March of this year, and office incident reporting began. The Board did not receive information on these reports until the July 2000 meeting. Information provided at that time was incomplete. The Board requested more comprehensive information, and directed the Board Chair to review the reports and provide the information at the August 2000 meeting. At its August meeting, the Board received information it had requested on adverse incident reports submitted in the five months since the requirement became effective. Information provided by the Agency for Health Care Administration (AHCA) raised substantial concern regarding ongoing level III office surgery. Since March 20, adverse incidents have been reported to AHCA all of which resulted in transfer of the patient to a hospital. Five (25%) of those patients died. Fifteen of the 20 adverse incidents (75%) related to surgical procedures, and 5 incidents were related to anesthesia. Based on his evaluation of the reports, the Chair advised that all of the deaths were anesthesia related. The Chair also informed the Board that the rate of deaths was higher than that occurring in ambulatory surgical centers. Accordingly, the Board determined that it was necessary to establish a standard of care that prohibits Level III surgeries in offices by putting in place by emergency rule a temporary moratorium against Level III office surgery.

Florida Medical Association Position: The FMA has filed a petition in the First District Court of Appeals requesting an emergency stay or an immediate injunction to block the Board of Medicine decision to impose a 90 day moratorium on Level III office based surgery. According to Mathis Becker, FMA President, "The legal basis of our challenge rests with our position that, while the question of the public's safety is a fundamental concern to all parties, the data on which the Board came to its decision is insufficient to result in the broad impact of this moratorium. The moratorium adopted by the Board of Medicine will cause innumerable patients, adults and children to have significantly less access to necessary procedures. There has been no data presented to the Board to support prohibiting these procedures from their being done in a safe environment under rules established by the Board after previous lengthy deliberations. The Board has established high standards of care in the interest of Florida citizens and holds each and every physician licensed by the Board to those standards. While medicine rigorously strives to continue to deliver the highest quality and safest care, each of us must understand that no therapeutic regimen is without risks. Each of us must clearly understand those risks of treatment and weigh such information in the decisions we make. The FMA's primary concern is the safety and well being of our patients. We do not believe the wide reach of this moratorium furthers that end." Despite these legal efforts by the FMA, on August 11, the District Court of Appeals denied the FMA's request for a stay or injunction.

It now appears that all interested groups have entered a healthy dialogue to advise the Board of Medicine on the next steps in the development of meaningful and effective rules for office based surgery that will serve the best interests of our patients. Obviously, given the passions and the politics, carving out these rules will be anything but simple; but ultimately, the success of these efforts will be measured in the outcomes achieved by Florida surgeons.

September, 2000/ Jacksonville Medicine

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