IOWA MEDICAL SOCIETY and IOWA SOCIETY OF ANESTHESIOLOGISTS, Appellees,
IOWA BOARD OF NURSING, Appellant, and IOWA ASSOCIATION OF NURSE ANESTHETISTS and IOWA NURSES ASSOCIATION, Appellants, and IOWA OSTEOPATHIC MEDICAL ASSOCIATION, Appellee.
Appeal from the Iowa District Court for Polk County, Artis I. Reis, Judge.
The Iowa Board of Nursing and intervenor nursing associations appeal from the district court's decision invalidating two administrative rules permitting advanced registered nurse practitioners to supervise fluoroscopy.
Thomas J. Miller, Attorney General, and Chantelle C. Smith and Sara M. Scott, Assistant Attorneys General, for appellant Iowa Board of Nursing.
James W. Carney and George W. Appleby of Carney & Appleby, P.L.C., Des Moines, for appellant Iowa Association of Nurse Anesthetists.
Judith R. "Lynn" Boes and Jodie C. McDougal of Davis, Brown, Koehn, Shors & Roberts P.C., Des Moines, for appellant Iowa Nurses Association.
Douglas A. Fulton and Paul A. Drey of Brick Gentry, P.C., West Des Moines, for appellee Iowa Medical Society.
Nicholas J. Mauro of Crawford Quilty & Mauro Law Firm, Des Moines, for appellee Iowa Society of Anesthesiologists.
Kimberly Bartosh and Erik S. Fisk of Whitfield & Eddy P.L.C., Des Moines, for appellee Iowa Osteopathic Medical Association.
In this appeal, we must decide whether the Iowa Board of Nursing and Iowa Department of Public Health exceeded their regulatory authority by enacting rules allowing advanced registered nurse practitioners (ARNPs) to supervise radiologic technologists using fluoroscopy machines. Several physician associations brought this court action against the nursing board and the department of public health to invalidate the rules. Two nursing associations intervened to defend the rules. The district court, on cross-motions for summary judgment, invalidated the rules after concluding that ARNP supervision of fluoroscopy has not been "recognized by the medical and nursing professions" within the meaning of Iowa Code section 152.1(6)(d) (2009), and the nursing board and the department of public health exceeded their authority in promulgating the rules. The nursing board and nursing associations appealed.
The Iowa legislature expressly granted the nursing board interpretive authority as to chapter 152. See Iowa Code § 147.76. In Renda v. Iowa Civil Rights Commission, we recognized that such a grant of interpretive authority requires deferential review of the agency's interpretation of the statute and its application of law to fact. 784 N.W.2d 8, 11 (Iowa 2010). By contrast, without a legislative grant of interpretive authority to the agency, we interpret the statute de novo, as is exemplified in our opinion in Iowa Dental Ass'n v. Iowa Insurance Division, ___ N.W.2d ___, ___(Iowa 2013). Applying Renda, we conclude that the nursing board's application of law to fact is not irrational, illogical, or wholly unjustifiable. We also conclude the rules fall within the authority of the nursing board and department of public health, and the other challenges to the rules fail. Accordingly, the rules at issue must be upheld. We therefore reverse the decision of the district court and remand for further proceedings consistent with this opinion.
I. Background Facts and Proceedings.
We begin with an overview before a more detailed discussion of the record. The challenged rules are Iowa Administrative Code rules 655— 7.2(2), adopted by the nursing board, and 641—41.1(5)(n), adopted by the department of public health. The rulemaking process preceding adoption of these rules generated extensive public comments supporting and opposing the rules as proposed. Supporters advocated adoption of the rules to improve access to healthcare (particularly in rural areas), enhance the safety of certain procedures, lower costs, and clarify the authority for existing practices ongoing for many years in parts of Iowa, which had been approved by various hospital credentialing committees staffed in part by physicians. Those opposed to the rules cited concerns with whether ARNPs were adequately educated and trained in radiation safety to supervise radiologic technologists, as well as other safety concerns, albeit without documenting a single injury attributable to an ARNP-supervised fluoroscopy procedure. The rules were adopted by the nursing board and the department of public health in June 2009 and April 2010, respectively. No objection to the rules was raised by the legislature's Administrative Rules Review Committee (ARRC), the governor, or the attorney general. Proposed legislation to nullify the rules failed in 2010. The battle moved to the courtroom.
On June 21, 2010, petitioners Iowa Medical Society and Iowa Society of Anesthesiologists filed petitions for judicial review against the nursing board and the department of public health. The district court granted motions to intervene by the Iowa Osteopathic Medical Association opposing the rules, and by the Iowa Nurses Association and Iowa Association of Nurse Anesthetists supporting the rules. The district court invalidated both rules by summary judgment. The nursing board, Iowa Nurses Association, and Iowa Association of Nurse Anesthetists appealed. The department of public health did not appeal.
We will now undertake a more detailed review of the agency record upon which our decision is based.
A. Rulemaking Proceedings.
In December 2006, a radiologic technologist contacted the department of public health's Bureau of Radiologic Health to inquire about who could supervise his operation of a fluoroscopy machine. The department of public health and the bureau began collaborating with the nursing board to address the inquiry and, ultimately, to develop rules permitting ARNPs to supervise fluoroscopic procedures performed by radiologic technologists. At that time both boards were aware that hospitals across the state had been credentialing ARNPs to supervise fluoroscopy and that several ARNPs had reportedly been supervising fluoroscopy for over twenty years.
The nursing board and the department of public health noted the ARNPs who were currently supervising fluoroscopic procedures may have been acting within the scope of their practice under the then-existing rules, but recognized those rules were unclear. The rule existing at that time provided that "[t]he use of fluoroscopic X-ray systems by radiologic technologists and students shall be performed under the direct supervision of a licensed practitioner of the healing arts for the purpose of localization to obtain images for diagnostic purposes." Iowa Admin. Code r. 641—41.1(5)(l)(2) (2008). "Licensed practitioner of the healing arts" is not included in the definition section in chapter 41; however, individual definitions for "licensed practitioner" and "healing arts" appear in an earlier chapter's definitions. See id. r. 641—38.2. Although found in a different chapter, these definitions apply to the rules found in several later chapters, including chapter 41. See id. ("As used in these rules, these terms have the definitions set forth below and are adopted by reference and included herein for 641—Chapters 39 to 45.").
"Healing arts" is broadly defined in chapter 38 as
the occupational fields of diagnosing or treating disease, providing health care and improving health by the practice of medicine, osteopathy, chiropractic, podiatry, dentistry, nursing, veterinary medicine, and supporting professions, such as physician assistants, nurse practitioners, radiologic technologists, and dental hygienists.
Id. (emphasis added). The term "licensed practitioner" is more narrowly defined as
a person licensed or otherwise authorized by law to practice medicine, osteopathy, chiropractic, podiatry, or dentistry in Iowa, or certified as a physician assistant as defined in Iowa Code section 148C.1, subsection 6, and is authorized to prescribe X-ray tests for the purpose of diagnosis or treatment.
Id. Nurse practitioners are not mentioned in this definition. Thus, supervision of fluoroscopy procedures performed by radiologic technologists was not within the scope of practice for ARNPs under the definitions contained in chapter 38 and applicable to the rule found in chapter 41.
On December 15, the nursing board made a finding that the scope of practice for ARNPs includes the ability "to order, perform, supervise and interpret x-ray tests [including fluoroscopy] for the purpose of diagnosis or treatment." The nursing board's finding garnered support from the Iowa Hospital Association,  the Iowa Association of Nurse Anesthetists,  and the Iowa Nurses Association. The nursing board's finding, however, was opposed by physicians' groups, including the Iowa Medical Society,  the Iowa Society of Anesthesiologists, and the Iowa Board of Medicine.
The discussions and debate continued for another three years. The department of public health noticed a proposed amendment to its subrule 41.1(5) in early 2007, but rescinded the proposed rule after receiving considerable opposition from physicians' groups. In June 2008, the nursing board rescinded its finding and continued working with these groups. In the end, after three years of collaboration, the nursing board and department of public health were unable to reach a workable compromise with these groups. On September 11, the nursing board referred the issue to its ARNP Advisory Committee to begin the rulemaking procedure.
1. The nursing board's rulemaking procedure.
The nursing board published its notice of intended action for its rule on April 22, 2009. The comment period for the rule was left open until June 3. Comments in support of the rule were received from several organizations, including the Iowa Association of Nurse Anesthetists, Iowa Nurse Practitioner Committee, the Iowa Hospital Association, and the Iowa Nurses Association. The nursing board also received comments in support of the rule from certified registered nurse anesthetists, hospitals, radiologic technologists, and physicians.
The Iowa Association of Nurse Anesthetists noted ways the rule will enhance patient safety and access to health care, and observed the absence of any reported injuries from ARNP-supervised fluoroscopy. The Iowa Hospital Association's letter of support for the rule noted that "[t]he proposed amendment would assure that ARNPs receive initial training in radiation physics, radiobiology, radiological safety and radiation management and additional annual training on time, dose, shielding and the effects of radiation." The nursing board also received supporting comments in letters from rural hospitals regarding their existing reliance on the supervision of fluoroscopy by a subspecialty of ARNPs. The Iowa Nurses Association observed the rule reflected existing practice.
The nursing board received comments in opposition from the board of medicine and several physicians' organizations, including the Polk County Medical Society, American Society of Radiologic Technologists, Iowa Society of Anesthesiologists, Iowa Medical Society, and the Iowa Radiologic Society. Individual comments opposing the proposed rule were received from radiologists, doctors, radiologic technologists, a dentist, and an associate professor for Trinity College of Nursing & Health Sciences' radiology program. The opposition focused on whether it was appropriate and safe for ARNPs to supervise persons who had more knowledge and experience in radiology and on whether the educational requirements set forth in the rule would adequately resolve this knowledge gap. One commentator, a radiologist from Cedar Rapids, raised concerns about radiation risks and inadequate training.
The professor at Trinity College expressed her concern that ARNPs, who "receive no education in radiation, radiation biology, or radiation protection, " would be supervising her students who "receive [hundreds] of hours of instruction solely on radiation protection and then many, many hours of practical application with skilled practitioners critiquing their radiation safety practices." The American Society of Radiologic Technologists opposed the proposed rule on grounds that one who supervises a procedure should be able to perform it. The Iowa Board of Medicine formally objected to the proposed rule because it viewed the ARNPs' training as insufficient.
The Iowa Society of Anesthesiologists' objection focused on "the proposed rule['s] attempts to expand nursing practice into the area of chronic interventional pain medicine, a highly specialized field that constitutes the practice of medicine, " and which involves life-threatening risks because it requires "[p]lacement of needles in proximity to vital spinal and vascular structures under fluoroscopic guidance."
Accordingly, the Society contended that "[i]f complications do arise, the physician must know how to respond correctly and immediately in order to avoid a disastrous outcome. Failure to understand any of the above can ultimately lead to paralysis, stroke, or death." The Society also disputed proponents' contention that this expansion was necessary to ensure patients in rural areas had access to chronic-pain medicine: "No deprivation exists for any patient in Iowa with regard to access to chronic pain medicine, because no Iowan lives more than two hours from a physician board certified in pain medicine." The Society further disputed the proponents' assertion that ARNPs have been supervising fluoroscopy for over twenty years, noting that "most procedures currently being taught within accredited pain medicine fellowships did not exist in their current forms prior to this decade." A physician downplayed the safety record of fluoroscopy by warning that it may take years for cancer to manifest from radiation exposure.
A public hearing for the rule was held on June 3. Twenty-two people attended the hearing, including representatives from the Iowa Nurses Association, the Iowa Association of Nurse Anesthetists, the Iowa Association of Nurse Practitioners, the Iowa Department of Public Health, the Iowa Radiological Society, the Iowa Medical Society, and the board of medicine. The nursing board's notice of the adoption and filing of ARC 7888B summarized the commentary from the public hearing as follows:
Comments opposing rules stated that education required was less than required of the radiological technologist or non radiological physician, did not require direct supervision by a radiologist, does not require the establishment of a collaborative practice agreement with a physician and is not recognized by the medical professions as being within the scope of practice. Comments also focused on radiological exposure of individuals involved. Comments supporting rule change were received from radiological technologists, physicians, hospital administrators, nurses, advanced practice nurse and associations.
The nursing board adopted rule ARC 7888B on June 10 and published the rule on July 1, with an effective date of August 5. The rule as promulgated provides:
7.2(2) Supervision of fluoroscopy. An advanced registered nurse practitioner (ARNP) shall be permitted to provide direct supervision in the use of fluoroscopic X-ray equipment, pursuant to 641—subrule 42.1(2), definition of "supervision."
a. The ARNP shall provide direct supervision of fluoroscopy pursuant to the following provisions:
(1) Completion of an educational course including content in radiation physics, radiobiology, radiological safety and radiation management applicable to the use of fluoroscopy, and maintenance ...