Boies, Schiller & Flexner, L. L. P., Albany (George F. Carpinello of counsel), for plaintiff.
Eliot Spitzer, Attorney General,
Albany (Charles J. Quackenbush of counsel), for defendants.
Bernard J. Malone, Jr., J.
The plaintiff is awarded summary judgment declaring that the Clinical Guidelines for Office-Based Surgery (Guidelines) promulgated by the defendants and published on the New York State Department of Health (DOH) Web site during December of 2000 are null and void and of no force and effect. The court finds that defendants' actions in enacting the Guidelines were ultra vires, and the plaintiff is granted a permanent injunction prohibiting the defendants from publishing, distributing or enforcing the Guidelines.
The plaintiff is a not-for-profit corporation representing over 750 certified registered nurse anesthetists (CRNAs). Defendant Novello is the Commissioner of DOH, and the New York State Public Health Council (Council) is a 15-member subdivision of DOH which " shall, at the request of the commissioner, consider any matter relating to the preservation and improvement of public health, and may advise the commissioner thereon; and it may, from time to time, submit to the commissioner, any recommendations relating to the preservation and improvement of public health" (Public Health Law § 225 ). DOH has a mandate of generally overseeing the public health interests of the state (see, Public Health Law § 201), and Public Health Law § 2800 provides: " Hospital and related services including health-related service of the highest quality, efficiently provided and properly utilized at a reasonable cost, are of vital concern to the public health. In order to provide for the protection and promotion of the health of the inhabitants of the state, pursuant to section three of article seventeen of the constitution, the department of health shall have the central, comprehensive responsibility for the development and administration of the state's policy with respect to hospital and related services, and all public and private institutions, whether state, county, municipal, incorporated or not incorporated, serving principally as facilities for the prevention, diagnosis or treatment of human disease, pain, injury, deformity or physical condition or for the rendering of health-related service shall be subject to the provisions of this article."
Pursuant to Public Health Law § 2800, DOH has promulgated rules for the administering of anesthesia in article 28 facilities,
such as hospitals. The Legislature has specifically withheld from the defendants the authority to regulate the conduct of physicians in non-hospital based settings, and the defendants concede that office-based surgical practices are not subject to regulation by them. As a consequence, since CRNAs are an available, qualified resource and since the services of CRNAs are much less expensive than the services of anesthesiologists, many office-based surgeries are conducted with CRNAs administering the anesthesia. Despite the fact that the defendants had no jurisdiction over the private practice of medicine outside of the article 28 context, they formed an ad hoc Committee on Quality of Assurance in Office-Based Surgery (Committee). One of the purposes of the Committee was to devise a way of regulating the administration of anesthesia in office-based surgeries regardless of the lack of statutory jurisdiction to do so. Consequently, the Committee requested a legal opinion from the General Counsel of DOH as to the statutory and regulatory authority over physician practices. The then General Counsel responded in a written memorandum dated May 11, 1998 (exhibit A of the affirmation of plaintiff's attorney dated Oct. 29, 2001) in which he stated:
" Under current law, there is no administrative agency or other entity with statutory authority over physician private practices, including office based-surgical practices. Physician professional conduct is regulated solely through disciplinary proceedings. Absent any such statutory authority, regulations governing the establishment and operation of physician office-based surgical practices cannot be promulgated. Guidelines, however, could be issued. Although such guidelines would not have the force of law, they could be useful as evidence of community standards of care in disciplinary proceedings."
The memorandum further states:
" The department clearly has the statutory authority to regulate facilities which fall within the statutory definition of hospitals. This statutory authority in article 28 does not, however, extend ... to physician private practices. Indeed, under applicable provisions of the EL (Education Law) and the PHL (Public Health Law), there is no authority pursuant to which the department, SED (State Education Department), the Board of Regents, the State Board for Medicine nor the Board may oversee physician private practice per se or promulgate regulations regarding physician ...