Under a new regulation that takes effect Oct. 1, Medicare will reimburse for a tracheo-esophageal voice prosthesis (TEP) that is inserted by a licensed health care provider (Healthcare Common Procedure Coding System code L8509) only if it is purchased by a provider, and will not reimburse for a TEP purchased by a Medicare-eligible laryngectomy patient.
Many laryngectomy patients who wear a TEP routinely purchase an extra to have available in case of prosthesis failure. The revised regulation, which ASHA is disputing with the Centers for Medicare and Medicare Services (CMS), would ensure that the patient's provider would have to purchase the extra TEP and would not receive reimbursement from Medicare until the prosthesis is dispensed to the patient.
This restriction is harmful to both patients and providers, according to ASHA's letter [PDF] to CMS. The change "interferes with the TEP's accessibility to the patient who has a laryngectomy in urgent situations and many providers will be reluctant to invest $1,000–$2,000 to stock TEPs," the letter states. "These problems will be eliminated if the patient is allowed to purchase the device."
The timeline for the breakdown of the prosthesis is unpredictable and different for each individual; for some patients, TEPs may deteriorate frequently.
The TEP may be plugged until it is replaced, but the individual then loses the capacity to communicate verbally. Under the new acquisition procedure, many providers will likely wait for a patient to inform them of difficulties (e.g., leaking) before ordering a replacement device, causing a delay in replacement that places the patient at risk. In addition, patients who are traveling need to have a replacement TEP with them, especially those traveling to places that lack qualified personnel who are familiar with the prosthesis.
Under the new policy, providers who want to provide optimal care for patients would need to maintain an inventory of TEPs that would be available to patients on demand. This inventory would have to be extensive for several reasons: each patient is measured for an individual prosthetic size; some patients fluctuate in size from the effects of radiation treatment; and some TEPs are further specialized to meet the individual's needs in terms of weight, esophageal flange size, candida resistance, and other specifications. Different manufacturers produce a variety of products to meet those needs. Maintaining this extensive inventory would place an unfair financial burden on the provider.
To review the change request, visit the CMS web site [PDF].