BALLOON SINUPLASTY - Health Plan of Nevada

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BALLOON SINUPLASTY 

Protocol: ENT009 

Effective Date: November 15, 2010 

Table of Contents 

Page 

COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE......................................... 1 

BACKGROUND ...................................................................................................................................... 2 

CLINICAL EVIDENCE........................................................................................................................... 3 

U.S. FOOD AND DRUG ADMINISTRATION (FDA).......................................................................... 5 

APPLICABLE CODES............................................................................................................................ 6 

REFERENCES ......................................................................................................................................... 6 

PROTOCOL HISTORY/REVISION INFORMATION .......................................................................... 7 

INSTRUCTIONS FOR USE 

This protocol provides assistance in interpreting UnitedHealthcare benefit plans. When deciding 

coverage, the enrollee specific document must be referenced. The terms of an enrollee's document 

(e.g., Certificate of Coverage (COC) or Evidence of Coverage (EOC)) may differ greatly. In the event 

of a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first 

identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage 

prior to use of this Protocol. Other Protocols, Policies and Coverage Determination Guidelines may 

apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Protocols, Policies and 

Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute 

medical advice. 

COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE 

Balloon sinuplasty during endoscopic sinus surgery is not medically necessary for the treatment of 

chronic sinusitis. 

Three uncontrolled studies conclude that balloon sinuplasty is feasible and appears to be safe; 

however additional studies are necessary to conclusively demonstrate the long-term durability of 

balloon sinuplasty as an alternative to endoscopic sinus surgery. 

Medicare does not have a National Coverage Determination or Local Coverage Determination for 

Nevada for Balloon Sinuplasty. (Accessed September 2010) 

For Medicare and Medicaid Determinations Related to States Outside of Nevada: 

Please review Local Coverage Determinations that apply to other states outside of Nevada: 

http://www.cms.hhs.gov/mcd/med/search. 

Balloon Sinuplasty Page 1 of 7

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Important Note: Please also review local carrier Web sites in addition to the Medicare Coverage 

database on the Centers for Medicare and Medicaid Service Website. 

BACKGROUND 

This protocol describes the use of balloon catheters during endoscopic sinus surgery for the treatment 

of chronic sinusitis. 

Sinusitis is an inflammation of the nasal sinuses, which are hollow cavities in the cheek bones found 

around and behind the nose. The inflammation is usually caused by inadequate draining due to allergy, 

infection or obstruction. Common symptoms include thick yellowish/green nasal discharge, headache, 

feelings of facial fullness, congestion, fatigue and fever (Slavin, 2005). 

Sinusitis is defined as acute when symptoms last for less than 4 weeks, subacute when lasting 4 to 8 

weeks and chronic when lasting for longer than 8 weeks. Physicians diagnose chronic sinusitis based 

on symptoms, examination which includes tests such as percussion and transillumination, and other 

tests such as x-rays, CT scan or MRI (NIH, 2008). 

Initial treatment of chronic sinusitis includes antibiotic treatment and possible analgesics, oral 

decongestants, nasal sprays and nasally inhaled steroids. If medical therapy fails, then surgery to drain 

the sinuses and reduce blockage of the nasal passages may be an alternative for treating chronic 

sinusitis (NIAID, 2007). 

Endoscopic sinus surgery (ESS) is accomplished using fiberoptic technology with an endoscope to 

visualize and remove blockages in the sinuses and improve breathing. Complications are uncommon 

but can occur during ESS and can include: intraoperative bleeding, scarring and adhesions, orbital 

injury and accidental penetration of the brain (Patel, 2008). Functional endoscopic sinus surgery 

(FESS), a minimally invasive procedure to treat chronic sinusitis, is also used. FESS differs from 

traditional sinus surgery in that a thin rigid optical telescope, called an endoscope, is used in the nose 

to view the nasal cavity and sinuses. FESS generally eliminates the need for an external incision. The 

endoscope allows for better visualization and magnification of diseased or problem areas. This 

endoscopic exam, along with CT scans, may reveal a problem that was not evident before. The intent 

of FESS is to widen the sinus passages to restore normal drainage and function. Recently, balloon 

dilation catheters have been introduced as an alternative to or adjunctive tool during conventional 

FESS (ECRI, 2008). 

Balloon sinuplasty is a minimally invasive procedure recently proposed for the treatment of chronic 

sinusitis, without any need for sinus tissue removal or bone resection. Sinus balloon catheterization is a 

surgical technique by which dilation of a paranasal sinus ostium is accomplished through use of a 

balloon catheter. The procedure involves insertion of a balloon dilation catheter over a guide-wire 

which has been positioned within the involved paranasal sinus under the direction of endoscopy and 

fluoroscopy. Inflation of the balloon results in dilation of the targeted ostium (AAO-HNS). Advantages 

of sinus balloon catheterization include minimal mucosal damage, minimal intraoperative bleeding and 

minimal discomfort (Brown, 2006). Balloon sinuplasty using balloon dilation catheters has been 


proposed for patients with chronic sinusitis who have failed antibiotic therapy, topical steroids and 

allergic management as demonstrated by an abnormal CT scan (Friedman, 2006). 

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CLINICAL EVIDENCE 

There are limited studies of published, peer reviewed literature available evaluating the outcome of 

patients undergoing the use of balloon dilation catheters during endoscopic sinus surgery or balloon 

sinuplasty. 

In a manufacturer sponsored, multi-center review, Levine et al. (with declared affiliation) conducted a 

standardized retrospective chart review of 1,036 patients (3,276 sinuses) having functional endoscopic 

sinus surgery that included the use of balloon catheter instruments (Levine, 2008). All of the patients 

had a diagnosis of chronic sinusitis unresponsive to medical management and who had undergone 

endoscopic sinus surgery. There were no exclusion criteria except that the participant was at least 18 

years of age with a median age of 47. Sinus guide catheters, sinus guide wires, and sinus balloon 

catheters (from a single manufacturer, Acclarent) were used in the study. Patients were followed for an 

average of 40.2 weeks. Balloon catheters were used widely across the maxillary, frontal, and sphenoid 

sinuses. The revision rate was 1.3% of sinuses treated with balloon catheters. Of the patients treated 

with balloon catheters, 95.5% reported improvement of their sinus symptoms. In addition, 73.8% of 

patients were free of sinus infections in the follow-up period after treatment with balloon catheters. No 

major adverse events attributed to the balloon catheter were reported. The authors conclude that the use 

of balloon catheters to treat patients with chronic sinusitis appears to be relatively safe and effective. 

This analysis is flawed by its retrospective nature, lack of long-term follow-up, lack of identified 

patient selection criteria and the author's financial conflict of interest. 

A NICE guidance document states that the current evidence on the short-term efficacy of balloon 

catheter dilation of paranasal sinus ostia for chronic sinusitis is adequate and raises no major safety 

concerns. Publication of long-term outcomes will be helpful in guiding the future use of this technique 

(NICE, 2008). 

Bolger et al. (2007) conducted a prospective, uncontrolled multi-center study of 115 patients to 

evaluate the safety and efficacy of balloon catheter sinusotomy. Patients enrolled in the study were 18 

years or older with a mean age of 47.8 years. Patients with extensive sinonasal polyps, extensive 

previous sinonasal surgery, extensive sinonasal osteoneogenesis, cystic fibrosis, sinonasal tumors, 

history of facial trauma that distorted sinus anatomy, ciliary dysfunction, and pregnancy were excluded 

from the study. During a 24 week follow-up, complication rates, patency, and sinus symptoms (Sino- 

Nasal Outcome Test or SNOT and patient questionnaire) were evaluated. Of the 115 patients, 109 

patients (358 sinuses) completed the study. At the end of the 24 week follow-up, endoscopy 

demonstrated that 80.5% of all sinuses were patent, 1.6% were nonpatent, and patency could not be 

evaluated in 17.9% of sinuses. Based on the patient questionnaire, 83%, 96%, and 84% of patients 

reported improved sinus symptoms at weeks 1, 12, and 24, respectively. These rates were similar for 

patients who underwent balloon catheter sinusotomy (85%, 98%, 80%) and for patients who 

underwent concurrent endoscopic surgery of different sinuses (80%, 94%, 88%). Sinus symptoms also 

improved based on SNOT 20 scores. There were no serious complications; however, 9 patients 

experienced bacterial sinusitis postdilation that resolved with oral antibiotic treatment and revision 


treatment was required in 3 sinuses. Device malfunction occurred in 12 of 358 sinuses. Based on these 

results, the authors conclude that balloon catheter technology appears safe and effective in relieving 

ostial obstruction. This study is flawed by the lack of randomization and lack of long-term follow up. 

In addition, postdilatation bacterial sinusitis is a serious complication. This study was extended by 

Kuhn et al. (2008), who performed 1-year follow-up examinations on 66 patients and 202 sinuses. At 

this point, 172 (85%) sinuses were patent, 2 (1%) were nonpatent, and 28 (14%) could not be 

evaluated. Further follow-up data were obtained by Weiss et al. (2008) who reported that, for 61 

available patients assessed 2 years after treatment, mean SNOT-20 symptoms scores decreased from 

2.2 at baseline to 0.9 and mean Lund-MacKay computed tomography (CT) sinusitis scores decreased 

from 10.2 at baseline to 2.7 (P

• In a group of selected patients, the use of balloon catheter dilation technology alone may 

eliminate the need for other surgical techniques. 

• Endoscopic balloon catheter dilation as a tool for dilating the opening of the maxillary 

sphenoid, and frontal sinuses is not investigational or experimental and should not be viewed as 

such (ARS, 2007). 

The American Rhinologic Society also endorses the AAO-HNS position statements regarding 

endoscopic balloon catheter dilation. 

Additional search terms 

balloon catheter dilatation, chronic rhinosinusitis, FEDS, recurrent sinusitis, sinus infection, rhinology, 

sinus balloon dilatation, sinus balloon dilation, sinus surgery 

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U.S. FOOD AND DRUG ADMINISTRATION (FDA) 

ExploraMed II, Inc. received 501(k) approval for the Relieva Sinus Balloon Catheter on April 5, 2005. 

This device is intended to provide a means to dilate the ostia and spaces within the paranasal sinus 

cavities for diagnostic and therapeutic procedures. Additional information available at: 

http://www.fda.gov/cdrh/pdf4/k043527.pdf. 

Acclarent, Inc. received FDA approval for the Relieva Sinus Catheter and the Relieva Sinus Guidewire 

on August 18, 2006. This device is intended to provide a means to access the sinus space and to dilate 

the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. 

Additional information is available at: http://www.fda.gov/cdrh/pdf6/K061903.pdf. 

Entellus Medical, Inc. received FDA approval for the Entellus Medical RS-Series System on April 8, 

2008. This device is intended to access and treat the maxillary sinus ostium and the ethmoid 

infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by 

balloon displacement of adjacent bone and paranasal sinus structures. A modification was approved on 

June 27, 2008 to change the tradename to FinESS Sinus Treatment. Additional information available 

at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081542.pdf. 


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APPLICABLE CODES 

The Current Procedural Terminology (CPT) codes and HCPCS codes listed in this policy are for 

reference purposes only. Listing of a service code in this policy does not imply that the service 

described by this code is a covered or non-covered health service. Coverage is determined by the 

benefit document. 

CPT Codes 

31299 Unlisted procedure, accessory sinuses 

HCPC Codes 

S2344 

Coding Clarification 

Nasal/sinus endoscopy, surgical; with enlargement of sinus ostium opening 

using inflatable device (i.e., balloon sinuplasty) 

Balloon sinuplasty may be reported with unlisted code 31299 or S2344. Operative reports may be 

needed to determine if balloon sinus dilatation was performed. 

REFERENCES 

Acclarent website. Available at: http://www.acclarent.com/. 

American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS). Sinus Balloon 

Catheterization Position Statement. March 2007. Available at: 

http://www.entnet.org/Practice/policySinusBalloonCatheterization.cfm. 

American Rhinologic Society Position Statement on Endoscopic Balloon Catheter Sinus Dilation 

Technology (Balloon Sinuplasty). May 2007. Available at: http://www.americanrhinologic. 

org/patientadvocacy.balloon.phtml. 

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 C, Bolger W. Safety and Feasibility of Balloon Catherter Dilation of Paranasal Sinus Ostia:A 

Preliminary Investigation. Annals of Otology, Rhinology & Laryngology. 2006:115(4):293-299. 

Chandra, R. Estimate of radiation dose to the lens in balloon sinuplasty. Otolaryngology head and 

Neck Surg. 2007;137(6):953-955. 

CRI Institute. Emerging Technology Report. Balloon catheter dilation for chronic sinusitis. December 

2008. Entellus Medical website. Available at: http://www.entellusmedical.com/. 


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Friedman M, Schalch P. Functional endoscopic dilatation of the sinuses (FEDS): Patient selection and 

surgical technique. Operative Techniques in Otolaryngology Head and Neck Surgery. 2006:17 (2):126- 

134. 

Hayes, Inc. Health Technology Brief. Relieva balloon sinuplasty (Acclarent Inc.) for treatment of 

chronic sinusitis. Lansdale, PA: Hayes, Inc.; November 2008. 

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 

Sep;139(3 Suppl 3):S27-37. 

Levine H, Sertich A, Hoisington D, Weiss R, Pritikin J. Multicenter Registry of Balloon Catheter 

Sinusotomy Outcomes for 1,036 Patients. Annals of Otology, Rhinology & Laryngology. 2008;117 

(4):263-270. 

National Institute of Allergy and Infectious Diseases (NIAID). Sinus Infection (Sinusitis). Last updated 

August 2007. Available at: http://www3.niaid.nih.gov/healthscience/healthtopics/sinus/. 

National Institutes of Health (NIH). Medline Plus Medical Encyclopedia. Sinusitis - Chronic. January 

30, 2008. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000677.htm. 

NICE. IPG 273 Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis. September 2008. 

Available at: http://www.nice.org.uk/nicemedia/pdf/IPG273Guidance.pdf. 

Patel, Ankit. Functional Endoscopic Sinus Surgery. eMedicine. March 6, 2008. Available at: 

http://www.emedicine.com/ent/TOPIC758.HTM#section~Complications. 

Slavin R, Spector S, Bernstein I. The diagnosis and management of sinusitis: A practice parameter 

update. Journal of Allergy and Clinical Immunology. November 2005. Available at: 

http://www.jacionline.org/webfiles/images/journals/ymai/5512.pdf. 

Weiss RL, Church CA, Kuhn FA, et al. Long-term outcome analysis of balloon catheter sinusotomy: 

two-year follow-up. Otolaryngol Head Neck Surg. 2008 Sep;139(3 Suppl 3):S38-46. 

PROTOCOL HISTORY/REVISION INFORMATION 

Date 

Retired 11/13/2009 

09/23/2010 

09/25/2009 

Action/Description 

Medical Technology Assessment Committee 

Corporate Medical Affairs Committee

BALLOON SINUPLASTY - Health Plan of Nevada

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