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Pollachek v. Department of Professional Regulation
Citation: Not availableDocket: 1-05-1337 & 1-05-1401 cons. Rel
Court: Appellate Court of Illinois; August 17, 2006; Illinois; State Appellate Court
Original Court Document: View Document
Peter J. Pollachek, a Certified Registered Nurse Anesthetist (CRNA), filed a complaint to permanently enjoin the Illinois Department of Professional Regulation (now the Department of Financial and Professional Regulation) from enforcing section 1305.45(e) of its regulations regarding anesthesia services. This section restricts CRNAs from providing such services in a physician's office unless the physician has training and experience in anesthesia delivery. The Cook County Circuit Court granted Pollachek's request, issuing a permanent injunction against the Department and awarding him $208,081.59 in fees and costs. Both parties appealed the decision. The court's review led to a reversal of the injunction and the fee award. The relevant background includes the enactment of the Nursing and Advanced Practice Nursing Act by the Illinois General Assembly in 1998, which established the licensure of advanced practice nurses, and subsequent amendments in 1999 that included provisions specific to CRNAs. This amendment reflected a consensus among various professional organizations, codifying existing practices for anesthesia delivery in Illinois. Section 15-25 of the Nursing Act allows CRNAs to provide anesthesia services under the order of licensed healthcare providers, with requirements for physician involvement during procedures. A certified registered nurse anesthetist (CRNA) providing anesthesia services in physician, dental, or podiatric offices must establish a written practice agreement with the relevant anesthesiologist, physician, dentist, or podiatrist. This agreement outlines their working relationship and specifies the types of care and procedures the CRNA is authorized to perform. In dental settings, CRNAs are limited to services permissible under the Illinois Dental Practice Act, while in podiatric settings, they may only provide services authorized by the Podiatric Medical Practice Act of 1987. An anesthesiologist, physician, dentist, or podiatrist must actively participate in the anesthesia plan and remain on-site during anesthesia delivery to address any emergency medical conditions. The Nursing Act established the Advanced Practice Nursing Board (APN Board), which advises the Department on regulations for advanced practice nurses, with members appointed by the Governor. Following the Nursing Act's section 15-25, the Department drafted implementation regulations with input from various stakeholders, leading to proposed rules published in the Illinois Register on September 22, 2000. Initial proposed rules under section 1305.45 did not mandate training for physicians working with CRNAs in office settings. The First Notice Period allowed public comments, during which concerns were raised by the Illinois State Medical Society (ISMS) regarding the anesthesia training of physicians, dentists, and podiatrists. In response, the Department proposed a training requirement of 2,200 hours in deep sedation, general anesthesia, or regional anesthesia, along with 60 hours in conscious sedation. The Joint Committee on Administrative Rules (JCAR) raised an objection to the Department regarding substantial changes made to rules without public commentary. On March 15, 2001, the Department amended and adopted new rules, including section 1305.45(e), which stipulates that a Certified Registered Nurse Anesthetist (CRNA) can only provide anesthesia services in a physician's office if the physician has documented training and experience in anesthesia delivery. This training can be satisfied by either holding hospital privileges for administering anesthesia or completing required continuing medical education (CME) hours: 8 hours for conscious sedation and 34 hours for deeper anesthesia forms, with specific requirements for the July 2002 renewal period. In July 2001, a licensed CRNA filed an amended complaint seeking injunctive relief against section 1305.45(e), arguing it exceeded the scope of the Nursing Act and violated the Illinois Administrative Procedure Act by not being published for public comment. The plaintiff contended that the rule’s inconsistency—requiring additional training for physicians when engaging CRNAs but not when performing anesthesia themselves—rendered it arbitrary and capricious. Cross-motions for summary judgment were filed by both the plaintiff and the Department regarding the validity of section 1305.45(e), but the circuit court denied both motions, citing unresolved material facts. Subsequently, the Department amended section 1305.45(e) effective April 26, 2003, transferring the CME requirements to the Medical Practice Act regulations. The Department revised the physician continuing medical education requirements, mandating that physicians performing anesthesia services must have documented training and experience, as specified in section 1305.45(e) of the Nursing Act regulations. A certified registered nurse anesthetist (CRNA) may only administer anesthesia in a physician's office if the physician meets these training requirements. The operating physician must also have relevant training to enter into a practice agreement with a CRNA, per section 1285.340 of the Medical Practice Act. An exception exists for anesthesiologists, who do not require the same training when administering anesthesia in a physician's office. Subsection (b) of section 1285.340 maintains the training criteria for physicians, with a compliance deadline set for July 31, 2003. The Department sought to dismiss the plaintiff's amended complaint, arguing that the amendments rendered the case moot. However, the circuit court initially granted this motion, stating the complaint was moot due to the new regulations. Upon appeal, the court reversed this dismissal, emphasizing that the regulations still require physician training for CRNAs to operate. The court did not resolve the merits of the plaintiff's claims but determined that the question of whether section 1305.45(e) was inconsistent with the Nursing Act remained valid. Following this, the plaintiff filed a second amended complaint seeking injunctive relief, alleging that section 1305.45(e) contradicts the Nursing Act and that the Department acted arbitrarily in establishing the rule. Plaintiff sought attorney's fees and costs under section 10-55 of the Illinois Administrative Procedure Act. A trial was held from August 30 to September 2, 2004, where six witnesses were called. Bonnie Robertson, a Certified Registered Nurse Anesthetist (CRNA) and executive director of the Illinois Association of Nurse Anesthetists (IANA), provided testimony on the training and certification requirements for CRNAs. She highlighted the history of the statutory enactments that introduced an 'active participation' requirement for physicians working with CRNAs. An order from December 10, 2003, struck all relief related to section 1305.45(i), which the plaintiff did not cross-appeal, thus waiving the issue. Robertson noted that the Nursing Act was amended in 1999 to formalize existing anesthesia delivery practices, allowing CRNAs to operate without scope-of-practice limitations in office settings for over a century prior to the enactment of section 1305.45(e). Leonard Sherman, a former department director, testified about the necessity for physician training as mandated by the Nursing Act's requirement for a written collaborative agreement with CRNAs. The plaintiff, a CRNA since 1989 and president of IANA, detailed the educational pathway to becoming a CRNA, which includes a bachelor’s degree in nursing, one year of acute care experience, and a 34-month residency. He also stated that CRNAs must complete 50 hours of continuing medical education biennially. The plaintiff discussed CRNAs' collaboration with licensed physicians in office settings, the management of potential anesthesia-related complications, and the ongoing advancements in anesthesiology that have increased safety. Additionally, he claimed that the regulation in question has negatively impacted his business, clients, and incurred additional costs. Plaintiff incurred additional costs by hiring anesthesiologists and physicians due to surgeons' reluctance to obtain anesthesia training for collaborating with Certified Registered Nurse Anesthetists (CRNAs). Despite these expenses, the plaintiff’s revenues have consistently increased. Expert witness Mitchell Tobin indicated that no other state mandates anesthesia training for physicians, highlighting that while New Jersey has such requirements, they are currently under litigation. He noted that Ohio requires continuing medical education in anesthesia for physicians working with CRNAs or anesthesiologists in office settings. Dr. John A. Greager, a surgical oncologist, testified about his two-year contract with Stat Anesthesia, stating his preference for CRNAs due to their patient interaction and cost-effectiveness. He expressed concerns that the new regulations hinder his practice since he cannot fulfill additional continuing medical education (CME) requirements alongside his specialty training. Dr. Greager deemed the anesthesia training requirements redundant, pointing out that surgical residents already receive extensive anesthesiology training. He asserted that his team, including CRNAs and anesthesiologists, is capable of managing emergencies effectively. Dr. Michael Pine presented data indicating that there was no significant difference in patient outcomes between care provided by CRNAs, anesthesiologists, and CRNAs collaborating with anesthesiologists in a hospital context, based on a study of eight high-volume elective procedures. The Department called witnesses including Leonard Sherman, Jean Courtney, and Dr. Kenneth Tuman. Sherman discussed the regulation-making process and the distinctions between CRNAs and anesthesiologists. Courtney, the rules coordinator, explained that the Advanced Practice Nurse (APN) Board advises on regulations, and public meetings are held to discuss these matters, with the Director having final approval. She noted that training hours for anesthesia were considerably reduced from those in the Dental Practice Act. Dr. Tuman distinguished the training paths of anesthesiologists and CRNAs, stating that anesthesiology is a four-year medical specialty, whereas CRNAs complete a nursing bachelor's degree followed by a 24- to 30-month program. He remarked that anesthesiology has become an elective for medical students, although they receive informal training during surgical rotations, along with lectures on anesthetic drugs. Dr. Tuman highlighted the inherent risks of anesthesia, such as airway and cardiovascular complications, and noted advancements in anesthesiology practices, medications, and equipment over the past decade. Dr. Tuman testified that an office setting poses greater risks to patients receiving anesthesia compared to a hospital setting, particularly if the attending physician lacks the necessary qualifications to manage complications. He referenced a Florida study by Dr. Villa that indicated a ten-fold increase in adverse outcomes in office settings versus ambulatory surgical centers. A subsequent follow-up study in 2002 showed that implementing safety regulations, such as requiring an anesthesiologist for specific anesthesia types in office settings, significantly reduced mortality rates. On October 1, 2004, a circuit court ruled to permanently enjoin the Department from enforcing section 1305.45(e) of the Nursing Act, concluding that the Nursing Act does not grant the Department authority to require additional anesthesia training for physicians working with nurse anesthetists in office settings. The court determined that enforcing this regulation would irreparably harm the plaintiff's ability to practice as a Certified Registered Nurse Anesthetist (CRNA) and provided no adequate legal remedy. The court denied the Department's motion to reconsider, affirming that the Nursing Act does not authorize additional training requirements. On March 23, 2005, the court awarded the plaintiff $208,081.59 for fees and costs under the Illinois Administrative Procedure Act. The Department appealed, arguing the court erred by granting the injunction and awarding fees, asserting that section 1305.45(e) is valid. Amicus curiae briefs were filed by the Illinois State Medical Society and the Illinois Society of Anesthesiologists supporting the Department, while the American Association of Nurse Anesthetists and the Illinois Association of Nurse Anesthetists backed the plaintiff's position that the regulation is unnecessary and discourages collaboration between surgeons and CRNAs. The regulation's validity is subject to de novo review, with the court assessing whether it aligns with the relevant statute's language. The court must analyze both the specific language and the overall design of the statute. If the statute is ambiguous or silent on the issue, the court evaluates if the agency's regulation constitutes a permissible interpretation. A regulation that does not conflict with the statute's plain language is afforded deference by the court. The court will also determine if the Department's requirement for Certified Registered Nurse Anesthetists (CRNAs) to work with physicians having advanced anesthesia training is arbitrary or capricious. Three standards of review are applicable: de novo, substantial evidence, and arbitrary or capricious. An agency action is considered arbitrary if it relies on unintended factors, overlooks significant elements, or contradicts the evidentiary basis. On appeal, the Department asserts that the circuit court wrongly deemed section 1305.45(e) invalid, arguing that it has authority under the Nursing Act. The Department points out that the continuing education requirements for physicians collaborating with CRNAs are governed by the Medical Practice Act, and section 1305.45(e) appropriately references these requirements. The amended section mandates that CRNAs may provide anesthesia services in a physician's office only if the physician possesses documented training and experience in anesthesia delivery, as outlined in the relevant regulations. Section 1305.45(e) outlines the conditions under which Certified Registered Nurse Anesthetists (CRNAs) can deliver anesthesia services in a physician's office. The training and experience mandates for physicians collaborating with CRNAs are specified in the Medical Practice Act regulations, which the plaintiff has not contested. These regulations necessitate that physicians possess additional qualifications to administer anesthesia or to establish a practice agreement with a CRNA. The requirements apply uniformly to both independent physicians and those working with CRNAs, ensuring that the Medical Practice Act does not deter physician-CRNA partnerships. Section 1305.45(e) of the Nursing Act merely cross-references these training requirements, a practice supported by precedent. To assess the compatibility of section 1305.45(e) with the Nursing Act's language, a detailed examination of the Act’s provisions is required. The Nursing Act comprises four titles, emphasizing the regulation of nursing as a matter of public health and safety. Section 5-5 asserts the public interest in ensuring that only qualified individuals practice nursing in Illinois. Title 15 addresses Advanced Practice Nurses, specifically in section 15-25, which allows CRNAs to provide anesthesia services under the direction of licensed medical professionals in various settings, with the stipulation that a supervising physician, dentist, or podiatrist must be present during the administration of anesthesia, unless alternative policies apply. A certified registered nurse anesthetist (CRNA) providing anesthesia services in physician, dental, or podiatric offices must establish a written practice agreement with the relevant supervising physician, dentist, or podiatrist. This agreement outlines their working relationship and specifies the types of care and procedures the CRNA is authorized to perform. In dental and podiatric settings, CRNAs are limited to services that the supervising dentist or podiatrist can legally provide according to the relevant Illinois statutes. The supervising professional must engage in the anesthesia plan and remain on-site to address any emergency medical needs during anesthesia delivery. Additionally, advanced practice nurses (APNs) are required to have a written collaborative agreement with a collaborating physician, detailing their working relationship and authorized care procedures. This collaboration allows APNs to deliver healthcare services based on their training and experience, while also including medical direction from the physician. The agreement does not need to specify every step for each medical condition but must clarify which procedures necessitate the physician's presence. The physician is not required to be physically present at all times, but effective communication methods must be established for consultation between the APN and physician. Consolidated Nos. 1-05-1337 and 1-05-1401 detail the responsibilities and authority of an Advanced Practice Nurse (APN) and the Department overseeing nursing practices in Illinois. Key responsibilities of the APN include joint formulation and approval of medical orders with the supervising physician, monthly on-site consultation, and availability for telecommunication to address medical issues or emergencies. The Nursing Act (225 ILCS 65/15-15) mandates the Department to regulate licensing, with the stipulation that no licensure or examination functions are executed without Board review. The Department is empowered to create rules to clarify the Act's provisions, contingent upon Board review. The court emphasizes that legislative intent should be discerned primarily from the statute's plain language, with all provisions interpreted collectively. The circuit court's ruling questioned the Department's authority to adopt a specific rule (section 1305.45(e)) under Title 15 for Advanced Practice Nurses, arguing that the enabling language is found in Title 10, which pertains to Registered Nurses and Licensed Practical Nurses. However, Title 15 defines Advanced Practice Nurses as licensed Registered Nurses under the same Act, asserting that the Department's authority to promulgate rules does not depend on the specific title of the regulation. Furthermore, the Department contends that section 1305.45(e) aligns with section 15-25 of the Nursing Act. Plaintiff asserts that section 1305.45(e) of the Nursing Act conflicts with section 15-25, which permits Certified Registered Nurse Anesthetists (CRNAs) to provide anesthesia services in a physician's office without restrictions, provided the physician is fully licensed and a written practice agreement exists. Section 15-25(a) mandates that a licensed CRNA administer anesthesia under a licensed physician's order, with the physician required to participate in and remain available during anesthesia services for emergency situations. Section 15-25(c) mirrors these requirements but adds that a written practice agreement is necessary between the CRNA and the physician. The text indicates that the legislative intent is for CRNAs to closely collaborate with physicians in anesthetic administration. Contrary to the plaintiff's claim, the Nursing Act imposes limitations on CRNAs in an office setting, necessitating collaboration with qualified physicians capable of discussing and agreeing on anesthesia plans. Section 1305.45(e) aligns with section 15-25 by ensuring CRNAs work only with physicians trained in anesthesia, capable of responding to potential emergencies. The plaintiff argues that section 1305.45(e) is inconsistent because it places no similar restrictions on CRNAs in physician's offices compared to those in dental or podiatric settings. The Nursing Act specifies that CRNAs can only offer services authorized by dentists or podiatrists, referencing their respective practice acts, while no such limitations exist in physician offices as long as appropriate agreements and qualifications are upheld. Plaintiff invokes the statutory construction principle of expressio unis est exclusio alterius, arguing that since the Illinois Dental Practice Act and Podiatric Medical Practice Act limit CRNAs in dental and podiatric offices, the absence of similar restrictions in physician offices indicates broader service permissions for CRNAs. However, the court finds this principle inapplicable because the Nursing Act imposes specific conditions on CRNAs in physician offices, including consultation with the physician on anesthesia delivery, a written service agreement, and the physician's physical presence during anesthesia administration (225 ILCS 65/15-25(a)). Consequently, the agency's regulation aligns with the statute's language. The court also examines whether the Department's requirement for CRNAs to work with physicians possessing additional anesthesia training (section 1305.45(e)) is arbitrary and capricious. Plaintiff claims this requirement conflicts with the Nursing Act, but the court determines that it is consistent with the Act. Furthermore, the plaintiff's arguments regarding the lack of studies on patient outcomes and economic impacts are unsupported by legal authority, and the legislature has differentiated between CRNAs and anesthesiologists. The Medical Practice Act (225 ILCS 60/54.5(b-5), (b-10)) specifies that certain collaborative responsibilities apply only when CRNAs administer anesthesia, not when anesthesiologists do so. Director Sherman’s testimony emphasized public safety over economic considerations, and it was noted that the Joint Committee on Administrative Rules did not mandate economic studies. Ultimately, the court concludes that the Department's regulation is not arbitrary or capricious, as it serves the Nursing Act's intent to protect public health and safety (225 ILCS 65/5-5). Plaintiff has not demonstrated that enforcement of section 1305.45(e) has caused economic hardship, as revenues have reportedly increased since its enactment, despite the necessity for more anesthesiologists over CRNAs. Testimony from Dr. Greager indicated a continued preference for CRNAs. Plaintiff contends that the Department's rationale for the regulation lacks credibility, citing the absence of hearings or data during the development of new physician anesthesia training requirements. It is argued that the Department's actions were arbitrary and capricious due to the introduction and subsequent reduction of training requirements. Evidence presented included comments from the Illinois State Medical Society (ISMS) advocating for physician training in CRNA services, noting the risks associated with anesthesia in office settings. Director Sherman emphasized the importance of physician training to fulfill responsibilities in anesthesia plans and emergency care, supported by Dr. Tuman’s testimony regarding the elevated risks in office settings compared to hospitals. Dr. Tuman referenced a Florida study showing significantly higher adverse outcomes in office settings and noted improvements in safety following the implementation of regulations requiring anesthesiologist involvement. Initially, Director Sherman proposed a 2,200-hour training requirement, reflecting dental continuing education standards, but revised this approach after recognizing that physicians receive more anesthesia training than dentists prior to licensure. Director Sherman engaged with various stakeholders to address concerns about the necessary training for physicians, leading to a modification of the Department's rule which reduced the required continuing medical education hours and mandated ongoing training. The Department provided valid reasons for requiring additional training in anesthesia for office-based physicians, and the court found no evidence of arbitrary or capricious actions in this regard. As a result of affirming the validity of section 1305.45(e), the circuit court erred in awarding fees and costs since such awards are only applicable if a rule is invalidated. The Illinois Administrative Procedure Act stipulates that fees and costs are awarded only when an administrative rule is overturned. Given that the Department's authority to enact the rule under the Nursing Act was upheld, the circuit court's order awarding fees and costs was vacated, and the prior ruling declaring section 1305.45(e) invalid was reversed.