New York State Governor Eliot Spitzer recently signed legislation to require State regulatory oversight for invasive procedures performed in physicians' offices and to permit dialysis companies that are owned by other business entities to provide end-stage renal dialysis (ESRD) services in New York State. 

The office-based surgery legislation requires that office-based surgery be performed by physicians in settings that have been accredited by an entity approved by the New York State Department of Health (DOH). The new law also requires that physicians report to the State adverse outcomes from office-based surgery, including patient deaths and unplanned hospital admissions, within one business day.  

GNYHA had strongly urged the New York State Legislature to enact this legislation in order to ensure patient safety. GNYHA believes that minimum safety standards will ensure a higher degree of patient safety for procedures performed in private physicians' offices. The adverse events reporting provisions of the bill become effective on January 14, 2008, although provisions regarding accreditation will not take effect until July 14, 2009.

The second law permits diagnostic and treatment centers established exclusively to provide ESRD services to be operated by corporations formed under New York State laws whose stockholders or members may include corporations. In effect, this would allow publicly traded corporations to own and operate these treatment centers. The operators must demonstrate to the New York State Public Health Council "sufficient experience and expertise in delivering high quality end stage renal disease care." The legislation provides that the New York State Public Health Council may promulgate rules and regulations to address issues related to the establishment and operation of dialysis centers established under the legislation. Currently, such corporations do provide dialysis services in New York State. However, they must contract with a hospital to do so, by means of an arrangement termed "representative governance." The legislation, which will require those operators to be directly accountable to DOH instead of being required to contract with a hospital, will become effective on January 14, 2008.