Medical Policies Online - Policy #: 11.16.06a

Medical Policy Bulletin

Title:

Balloon Sinuplasty for the Treatment of Chronic Sinusitis

Policy #:

11.16.06a

The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.

Intent

The intent of this policy is to communicate that balloon sinuplasty is considered experimental/investigational.

For information on policies related to this topic, refer to the Cross References section in this policy.

Description:

Paranasal sinuses are cavities within the skull that lead into the nose and are lined with the same type of membranes that line the inside of the nose. When one or more of the sinus cavities are inflamed and the sinuses cannot drain properly, a condition known as sinusitis develops. Sinusitis often results in an infection that can be bacterial, fungal, or viral and can be caused by inflammation and allergies.

Chronic sinusitis may persist for three months or longer, the symptoms of which may include:

Nasal congestion
Facial pain
Headache
Fever
General malaise
Purulent nasal discharge
Increased sensation of facial fullness on bending over
Aching teeth

If aggressive medical management does not improve symptoms, surgical drainage of the sinuses may be necessary. Endoscopic sinus surgery has become important in the surgical management of chronic sinusitis. A fiber-optic nasal endoscope is used to visualize the sinus ostia. Any obstruction found in the sinus ostia is then corrected, which restores patency and allows mucous transport through the natural ostium.

Balloon sinuplasty has been investigated as an alternative to endoscopic sinus surgery. In the balloon sinuplasty procedure, a device such as the Relieva� Sinus Balloon Inflation Device (Acclarent�, Inc.; Menlo Park, CA) or the Relieva� Sinus Balloon Dilation Catheter (ExploraMed� NCI, Inc.; Mountain View, CA) is used to stretch and open the sinus ostia to improve sinus drainage.

There is a paucity of peer-reviewed, published literature and/or clinical studies regarding balloon sinuplasty. The long-term safety and efficacy of balloon sinuplasty is unknown. Randomized studies and longer-term outcome data are needed.

Policy

Although the US Food and Drug Administration (FDA) has approved several devices for balloon sinuplasty, the Company has determined that the safety and/or efficacy of balloon sinuplasty for the treatment of chronic sinusitis cannot be established by review of the available published peer-reviewed literature. Therefore, this procedure is considered experimental/investigational by the Company and not covered.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, balloon sinuplasty is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered. Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

MEDICARE

There is no Medicare coverage criteria addressing this service; therefore, the Company policy is applicable.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are several devices that have received 510(k) approval from the FDA for use with the balloon sinuplasty procedure.

References

Bolger WE, Brown CL, Church CA, et al. Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients. Otolaryngol Head Neck Surg. 2007;137(1):10-20.

Brown DL, Bolger WE. Safety and feasibility of balloon catheter dilation of paranasal sinus ostia: a preliminary investigation. Ann Otol Rhinol Laryngol. 2006;115(4):293-301.

Chandra RK. Estimate of radiation dose to the lens in balloon sinuplasty. Otolaryngol Head Neck Surg. 2007;137(6):953-955.

Friedman M, Schalch P, Lin HC, et al. Functional endoscopic dilation of the sinuses: patient satisfaction, postoperative pain, and cost. Am J Rhinol. 2008;22(2):204-209.

Kuhn FA, Church CA, Goldberg AN, et al. Balloon catheter sinusotomy: one-year follow-up – outcomes and role in functional endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2008;139(3 suppl 3):S27-S37.

Lanza DC, Kennedy DW. Balloon sinuplasty: not ready for prime time. Ann Otol Rhinol Laryngol. 2006;115(10):789-790.

Levine HL, Sertich AP 2nd, Hoisington DR, et al. Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. Ann Otol Rhinol Laryngol. 2008;117(4):263-270.

National Institute of Health and Clinical Excellence (NICE). Interventional procedure guidance 273: Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis. [NICE Web site]. September 2008. Available at: http://www.nice.org.uk/nicemedia/pdf/IPG273Guidance.pdf. Accessed January 26, 2010.

Ramadan HH. Safety and feasibility of balloon sinuplasty for treatment of chronic rhinosinusitis in children. Ann Otol Rhinol Laryngol. 2009:118(3):161-165.

Taghi AS, Khalil SS, Mace AD, Saleh HA. Balloon sinuplasty: balloon-catheter dilation of paranasal sinus ostia for chronic rhinosinusitis. Expert Rev Med Devices. 2009;6(4):377-382.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Relieva� Sinus Balloon Dilation Catheter. 510(k) summary. [FDA Web site]. 04/05/05. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/K043527.pdf. Accessed January 5, 2010.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Relieva� Sinus Balloon Inflation Device. 510(k) summary. [FDA Web site]. 08/31/05. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K052198.pdf. Accessed January 5, 2010.

Vaughan WC. Review of balloon sinuplasty. Curr Opin Otolaryngol Head Neck Surg. 2008;16(1):2-9.

Weiss RL, Church CA, Kuhn FA, et al. Long-term outcomes analysis of balloon catheter sinusotomy: two-year follow-up. Otolaryngol Head Neck Surg.2008;139(3 suppl 3):S38-S46.

Wittkopf ML, Becker SS, Duncavage JA, Russell PT. Balloon sinuplasty for the surgical management of immunocompromised and critically ill patients with acute rhinosinusitis. Otolaryngol Head Neck Surg. 2009;140(4):596-598.

Coding Table

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

Code System	Code Number(s) and Narrative(s)
CPT	N/A
ICD Procedure	N/A
ICD Diagnosis	This procedure is experimental/investigational for all diagnoses.
HCPCS Level II	S2344: Nasal/sinus endoscopy, surgical; with enlargement of sinus ostium opening using inflatable device (ie, balloon sinuplasty)

Revenue Codes	N/A

Cross References

Cross Reference Policies

12.01.01f:

Experimental/Investigational Services

Version Effective Date: 01/14/2008