New Bill Proposed in Senate to Regulate Upper Endoscopic Procedures

May 26, 2016 | Health Services

A new bill has been introduced in the New York Senate that would require the Department of Health to promulgate rules governing all upper endoscopic procedures, including all examinations of vocal cords, esophagus, and stomach that utilize a flexible endoscopic instrument. Approximately ten million upper endoscopic procedures are performed in the United States each year. Majority of the procedures are performed as a sedated upper endoscopic procedure which, according to the new bill, entails significant health risk and financial cost. The bill states that sedation required to perform the procedure costs an additional $3,000.00 and carries an additional 5% risk of complications, both of which can be mitigated by performing an alternative transnasal esophagoscopy (“TNE”) procedure. TNE is performed while the patient is fully awake and upright—it does not require anesthesia and is therefore considered less dangerous and less expensive. 

To protect patient safety, the proposed Endoscope Reform Act will require that all upper endoscopic procedures are performed as a TNE. A sedated upper endoscopy would only be permissible when one of the following exceptions applies: (1) the physician determines that TNE is not an available or suitable procedure; (2) the physician determines that a sedated upper endoscopy is a more suitable or effective procedure in treating the patient; or (3) the patient, after being informed of the upper endoscopic patient’s bill of rights, elects to undergo a sedated upper endoscopy. The Act requires the Department of Health to draft a bill of rights for upper endoscopic patients that will serve as a standard form explaining the respective risks and benefits of both types of procedures. Physicians will be required to read the form to all patients. Moreover, in cases where the physician determines that TNE is an available and suitable option, the physician will be required to inform the patient that the procedure can be performed without sedation and accordingly, without the risks associated with a sedated upper endoscopic procedure. 

 The proposed Act also requires the Department of Health to promulgate rules governing the use of flexible fiberoptic endoscopic instruments. Specifically, to prevent transmission of infectious and contagious diseases, such as Creutzfeld-Jacob disease and tuberculosis, the rules would require physicians to abide by certain sterilization protocols. If sterilization is not possible, the physician would be required to obtain written consent from the patient that he or she was informed that the instrument was disinfected but not sterilized and understands the difference between disinfection and sterilization.

While it is unclear whether the bill will be passed by the Senate, it has been referred to the Senate’s Health Committee for further review.

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