July 1, 2013
Volume 77, Number 7
State Regulation: The ‘Other’ White Meat
Jennifer Root, M.D. Committee on Governmental Affairs
Margarita M. Pate, Ph.D., Executive Director South Carolina Society of Anesthesiologists
We are all familiar by now with the process of passing legislation. It has been compared to the process of “making sausage.” This legislative process usually involves multiple hearings, citizen input, negotiations with lobbyists and other internal workings that take a bill from the drop box to the desk of the governor for signature. You win some bits, you lose some bits, and you hope at the end that a workable compromise has been reached for all parties involved. This can resemble the slaughterhouse at times, with the perfect sausage in its snug casing hiding myriad less-clean processes that went into its making. It is, however, a fairly transparent process on full grisly view. After your legislature enacts legislation, the Executive Branch and applicable state agencies must implement it. The law provides only the outline of a program, and it is the responsibility of the Executive Branch, through the regulatory process, to translate the law into policy. This is a critical part of the process for a grassroots organization, to ensure that the implementation of the law meets the intentions of the parties that created it. Influencing the making of the law is only part of the process for successfully protecting the practice of medicine.
There are other sources of change within our state and our country, however, that aren’t as participatory as passing legislation. A secondary method of implementing law and fostering change within state and federal agencies, otherwise known as regulations, are far more worrisome in that there is often less transparency and often lack input into the process with little or none of the “working together” that is required to get a law passed. If you are lucky to be invited to the regulatory table, you might be able to enter comments during a comment period, but even so, the final rule is often politically motivated and is made over the serious arguments of others.
Our state society’s executive director notifies our executive committee of any new bills that concern us, and she also passes along any regulatory changes of interest that have received the required public notice in our state register. Each state has its own process for making changes to regulations, but here in South Carolina, a notice is placed in our state register, and the new regulation is sent by the involved state agency to a committee in our House and Senate for an up-or-down approval. A regulation in South Carolina, in contrast to a bill, cannot be changed materially by the general assembly, and either gets the straight thumbs up or down. Further complicating the matter, after 180 days the proposed regulation will automatically enter our state regulations if nothing at all is done. It is not hard to imagine that those not looking for a particular regulation could easily find themselves with no recourse through this process. The vigilance so necessary for our specialty could not be more on point for the regulatory process, because while there is a public notice, it is often in an obscure place and often it is only by chance that you may find out what is in the works prior to its arrival in the legislature.
In spring 2012, our executive director discovered that a proposed regulation was in the works that involved the South Carolina Board of Chiropractic Examiners. It was presented as a “clean-up” regulation, meaning changes that remove conflicts in language, typos and other non-substantive changes. For some boards, “clean up changes” are creatively defined, as was the case with the chiropractic board’s move in 2012. Buried many pages into this document under “scope of practice” was a one-line addition ... “Manipulation Under Anesthesia” (MUA). To say we were taken by surprise is an understatement, as we were unaware of this practice even occurring in our state. It was the only mention at all of MUA within the document. The proposed language had no requirements for who could perform MUA, educational background of the provider, the types of practitioners who were to be involved or any patient safety measures. The chiropractic board had not involved our state anesthesia society, nor had it involved the state board of medical examiners in writing this regulation. Whether you are a believer in MUA or, like the 2007 ASA House of Delegates (HOD), you believe that MUA has been found to be neither safe nor effective, this was not the main issue at hand. Our specialty, by name, was being dragged into a statutory area where we did not belong and that did not allow our board of medical examiners any oversight, and the proposed regulation lacked any sort of patient safety measures.
We immediately wrote letters to our state’s chiropractic board and additionally began to notify our friends in the state house of the appearance of this regulation. Our position was that this procedure was beyond the scope of practice of chiropractors. We also engaged our South Carolina Medical Association and our state’s orthopedic association to write letters as well. About a month later, we were invited to attend a meeting of the chiropractic board for public testimony. We stated our position on the practice of MUA and our concerns for patient safety that were not included in their proposed regulation. The chiropractic board disregarded the position of the medical community and would not change the proposed regulation, so we then approached our own state medical board and asked for an official advisory opinion on whether MUA constituted the practice of medicine. Our state board of medical examiners agreed that this did constitute the practice of medicine. This decision created a conflict within our state regulatory agency, and so it sent the issue to an administrative law judge to sort out.
At about six months into this issue, we had the pleasure of appearing in front of a judge to explain why we felt that MUA was the practice of medicine, that MUA stood in direct conflict with the statutory prohibition in the Chiropractic Practice Act against the use of “drugs or surgery” in the delivery of chiropractic care, and that the regulation held no patient protections and was not in the best interests of the state as it was written. We are sure that the intensity of the legal process was nowhere near that of a malpractice suit, but trying to enter a court of law and present legal arguments on what constituted the practice of medicine can be very difficult for those of us who are not trained in law. The judge decided not to rule on this issue immediately (although we believe we were successful with our arguments) and asked the two boards (medical examiners and chiropractic examiners) to meet and see if they could work out a compromise.
We were able to work out a compromise that allowed chiropractors to participate in the procedure, but that the procedure itself was still clearly in the realm of medicine. Inside the regulation were strict guidelines as to who could provide the anesthesia (only an anesthesiologist), where it could take place and how individuals were to be credentialed for this procedure. We all personally felt there still was no valid science to support doing this, but at least it would be done by an M.D. or D.O. with the protections that all patients receive when they go into the O.R. This past January, the newly revised regulation with our agreed-upon language was published into our state register and sent to our legislative subcommittees for review.
Regulation has become a much wider concern in terms of where the details of the practice of medicine and other disciplines are being governed. The legislative logjam that exists both at state and federal levels has reduced considerably the number of laws being passed. The real action and volume has moved to the regulatory process. A significant polarization due to ideological differences has driven wedges within the legislative process, leading to a logarithmic increase in the last three decades of rules driven by regulation. As we face greater economic challenges, the divisions between the political parties are only amplified, leading to a continued path toward more regulation. Use of regulation is pushed as a technical fix, but so very often becomes a source of problems itself. Physicians must work diligently to make connections with not only our legislators, but our regulatory agencies and others in our state that influence these rule-making processes. We don’t foresee it slowing down in the future, and regulation is the perfect vehicle for others to step into areas traditionally under the auspices of the House of Medicine.
Jennifer Root, M.D. is a self-employed Anesthesiologist in Columbia, South Carolina, currently the Secretary/
Treasurer of the South Carolina
Society of Anesthesiologists, and Speaker of the House for the
South Carolina Medical Association.
Margarita M. Pate, Ph.D. is Executive Director of the South Carolina Society of Anesthesiologists, Charleston,