Palatal Implants for the Treatment of Obstructive Sleep Apnea or Snoring
Palatal implants are intended to stiffen and change the airflow characteristics of the soft palate tissue (e.g., Pillar® Palatal Implant System). The airflow change has been proposed to reduce the severity of snoring and the incidence of airway obstructions for individuals with mild to moderate obstructive sleep apnea (OSA). The devices are cylindrical shaped segments of braided polyester filaments that is permanently implanted in the soft palate. A delivery tool comprised of a handle and needle assembly allows for positioning and placement of three implants. The procedure is performed under local anesthetic in an outpatient setting.
CPAP is the preferred first-line treatment of obstructive sleep apnea for most individuals. A smaller number of individuals may use oral appliances as a first-line treatment.
POLICY
Palatal implants for the treatment of obstructive sleep apnea or snoring is considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
The literature on palatal implants consists of two small randomized controlled studies and a few additional case series with medium-term follow-up. Additional study is needed to determine whether there is a defined subset of individuals who might benefit from this procedure. Studies with longer term follow-up are also needed to evaluate the long-term risk of implant extrusion.
SOURCES
American Academy of Otolaryngology. (2021). Position Statement: Surgical management of obstructive sleep apnea. Retrieved November 3, 2022 from http://www.entnet.org/content/practice-management-resources.
American Academy of Sleep Medicine. (2010). Practice parameters for the surgical modifications of the upper airway for obstructive sleep apnea in adults. Retrieved January 8, 2019 from https://aasm.org/clinical-resources/practice-standards/practice-guidelines/.
BlueCross BlueShield Association. Evidence Positioning System. (7:2023). Surgical treatment of snoring and obstructive sleep apnea syndrome (7.01.101). Retrieved December 14, 2023 from https://www.bcbsaoca.com/eps/. (52 articles and/or guidelines reviewed)
Choi, J .H. Kim, S. N., and Cho, J. H. (2013). Efficacy of the Pillar implant in the treatment of snoring and mild-to-moderate obstructive sleep apnea: a meta-analysis. Laryngoscope, 123 (1), 269-276. Abstract retrieved June 8, 2015 from PubMed database.
Lee, L., Yu, J., 4, Lo, Y., Chen, N., Fang, T., Huang, C., et al. (2014). Comparative effects of snoring sound between two minimally invasive surgeries in the treatment of snoring: A randomized controlled trial. PLOS One, 9 (5), e97186. (Level 2 evidence)
National Institute for Health and Care Excellence. (2007; last updated January 2012). Soft-palate implants for obstructive sleep apnea. Retrieved March 21, 2017 from www.nice.org.uk/guidance/ipg241.
National Institute for Health and Care Excellence. (2007; last updated January 2012). Soft-palate implants for simple snoring. Retrieved March 21, 2017 from www.nice.org.uk/guidance/ipg240.
U. S. Food and Drug Administration. (2002, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K011723. Retrieved July 21, 2010 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2004, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K040417. Retrieved July 21, 2010 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 9/11/2005
MOST RECENT REVIEW DATE: 2/8/2024
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.