Dialysis treats end-stage kidney failure by removing waste from a patient's blood when the kidneys are no longer able to perform the function. There are different types of dialysis, including hemodialysis and peritoneal dialysis. Hemodialysis removes blood from the body and filters it through a machine and returns it to the body. Hemodialysis is usually performed in a health care setting, but may be done at home. Peritoneal dialysis filters blood by sending a dialysis solution, called dialysate, through a catheter into part of the abdomen where it filters waste products from the blood through the lining of the abdomen. Peritoneal dialysis is frequently performed at home by the patient or the patient's caregiver.
Medicare-approved home dialysis centers or facilities operating Medicare-approved home dialysis programs may sell, deliver, possess, or dispense legend drugs to dialysis patients, as authorized by the Pharmacy Quality Assurance Commission (Commission). The Commission's rules authorize four products: sterile heparin, sterile potassium chloride, commercially available dialysate, and sterile sodium chloride. In addition, the home dialysis program must have an agreement with a pharmacist to provide any necessary consultation on issues such as the drug distribution process to home dialysis patients and the location used for storage and distribution of the drugs. The Commission also requires that home dialysis programs provide and retain certain records related to shipment and that they maintain a quality assurance program for drug distribution.
Pharmacy and legend drug regulations may not prevent a manufacturer or wholesaler from selling, delivering, possessing, or dispensing dialysis devices and related legend drugs, including commercially available dialysate, used by home dialysis patients directly to dialysis patients. The requirement that the dialysis devices and drugs be prescribed by a physician or osteopathic physician is expanded to include any practitioner acting within the scope of the practitioner's practice.
The substitute bill changes the terminology related to those covered by the exception to pharmacy and legend drug regulations from "manufacturers of commercially available dialysate and dialysis devices used by home dialysis patients or their agents" to "manufacturers" or "wholesalers" which are defined terms within the pharmacy statutes. The types of health care providers who may prescribe to the home dialysis patient under the exception are expanded from physicians and osteopathic physicians to any practitioner acting within the scope of the practitioner's practice.
(In support) This bill is about ensuring that persons undergoing kidney dialysis treatment have the ability to do that in the comfort of their homes. It is more comfortable to have dialysis at home and it reduces child care costs and transportation costs, especially for those with mobility issues. Home dialysis offers patients the ability to schedule treatments around their personal lives. Home dialysis requires fewer medications due to fewer dialysis treatment cycles.
Current law imposes significant requirements on the distribution of home dialysis supplies and devices by aligning kidney-specific services to those of retail pharmacies. Given the volume of fluid that these products contain, this product is difficult for pharmacies to dispense directly to patients. This bill will help seamlessly deliver home dialysis to Washingtonians by removing unnecessary barriers while maintaining patient safety. This bill will allow manufacturers of dialysis home supplies and devices to be exempted from pharmacy and legend drug laws if they maintain control of the product from manufacturing to the patient. This bill will streamline the operations of dialysis solution and device manufacturers. This policy is aligned with 30 other states.
(Opposed) None.