Relates to enacting the "Endoscope Reform Act"

Section 2: Directs the commissioner of health to promulgate rules and regulations for the practice of all endoscopic procedures. Upper endoscopic procedures will include all examinations of a patient's vocal cords, esophagus, and/or stomach by the use of a flexible endoscope instrument.

To avoid the dangers of sedation, all upper endoscopic procedures will be required to be performed through a TNE. TNEs are performed with the patient fully awake and upright and require no anesthesia. Exceptions to the requirement that TNEs be used will be made in the event that the treating physician determines that TNE is not available or suitable in treating a patient; the treating physician determines that a sedated upper endoscopy is more suitable or effective for a patient; or the patient, after being informed of the TNE procedure, elects to use the sedated procedure instead.

Section 3: Patients will be informed of the TNE procedure and will also be advised of the risks of a sedated procedure.

The commissioner of health will create an "upper endoscopic patient's bill of rights," which will include the risks and benefits of each procedure, including the risks of sedation and respective costs.

Section 4: The commissioner of health shall also establish rules and regulations to govern the use of flexible fiberoptic endoscopic instruments. The instrument must be sterilized after each use or have all surfaces completely covered by a single use protective sleeve. If sterilization is not possible, the patient must give written consent indicating the difference between disinfection and sterilization has been explained.

Section 5: Effective date.

Justification

Approximately ten million upper endoscopic procedures are performed annually in the U.S., and that number is growing. While these procedures are of great and critical value in examining a patient's vocal chords, esophagus, and/or stomach, and in diagnosing and treating serious diseases such as acid reflux disease and esophageal cancer, these upper endoscopic procedures are currently being widely performed using only a sedated upper endoscopic procedure, a procedure that necessarily carries significant health risks and great financial costs to patients.

These health risks and financial costs can be avoided by an alternative method of upper endoscopic procedure, TransNasal Esophagoscopy ("TNE"), which is performed with the patient fully awake and upright, thereby avoiding the health risks attendant to sedation and saving patients and the health care industry billions of dollars in costs that are needlessly incurred when the sedated method is utilized. Every time a sedated upper endoscopic procedure is performed, facilities and sedation are required that cost patients approximately three thousand dollars ($3,000.00). Accordingly, with revenues from these sedated upper endoscopic procedures accounting for approximately thirty billion dollars annually, there is a distinct financial disincentive for certain healthcare providers to offer the safer, less expensive TNE procedure.

Moreover, sedated upper endoscopic procedures carry approximately a 5% risk of complications such as "cardiopulmonary unplanned events", some of which result in fatalities, and these health risks can be completely avoided by the use of the TNE procedure.

By requiring that all upper endoscopic procedures be performed by the use of the safer and more affordable TNE procedure, with exceptions for circumstances when a sedated procedure may be more suitable, effective, or preferred by the patient after an explanation of the "Upper Endoscopic Patient's Bill of Rights", patients and the healthcare industry as a whole will save billions of dollars that have previously been paid toward unnecessary sedation and facilities, and the significant health risks attendant to sedated upper endoscopic procedures will be completely avoided.

By requiring sterilization, or having all surfaces completely covered by a protective single use sterile barrier device, in the use of all upper endoscopic procedures, the transmission of infectious contagious diseases, and in particular highly contagious pathogens that result in Creutzfeldt Jacob Disease and tuberculosis, will be prevented.

Legislative history

None

Fiscal implications

There are no fiscal implications.

Effective date

This act shall take effect immediately.