BALLOON SINUPLASTY - Health Plan of Nevada
BALLOON SINUPLASTY - Health Plan of Nevada
BALLOON SINUPLASTY - Health Plan of Nevada
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<strong>BALLOON</strong> <strong>SINUPLASTY</strong><br />
Protocol: ENT009<br />
Effective Date: November 15, 2010<br />
Table <strong>of</strong> Contents<br />
Page<br />
COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE......................................... 1<br />
BACKGROUND ...................................................................................................................................... 2<br />
CLINICAL EVIDENCE........................................................................................................................... 3<br />
U.S. FOOD AND DRUG ADMINISTRATION (FDA).......................................................................... 5<br />
APPLICABLE CODES............................................................................................................................ 6<br />
REFERENCES ......................................................................................................................................... 6<br />
PROTOCOL HISTORY/REVISION INFORMATION .......................................................................... 7<br />
INSTRUCTIONS FOR USE<br />
This protocol provides assistance in interpreting United<strong>Health</strong>care benefit plans. When deciding<br />
coverage, the enrollee specific document must be referenced. The terms <strong>of</strong> an enrollee's document<br />
(e.g., Certificate <strong>of</strong> Coverage (COC) or Evidence <strong>of</strong> Coverage (EOC)) may differ greatly. In the event<br />
<strong>of</strong> a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first<br />
identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage<br />
prior to use <strong>of</strong> this Protocol. Other Protocols, Policies and Coverage Determination Guidelines may<br />
apply. United<strong>Health</strong>care reserves the right, in its sole discretion, to modify its Protocols, Policies and<br />
Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute<br />
medical advice.<br />
COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE<br />
Balloon sinuplasty during endoscopic sinus surgery is not medically necessary for the treatment <strong>of</strong><br />
chronic sinusitis.<br />
Three uncontrolled studies conclude that balloon sinuplasty is feasible and appears to be safe;<br />
however additional studies are necessary to conclusively demonstrate the long-term durability <strong>of</strong><br />
balloon sinuplasty as an alternative to endoscopic sinus surgery.<br />
Medicare does not have a National Coverage Determination or Local Coverage Determination for<br />
<strong>Nevada</strong> for Balloon Sinuplasty. (Accessed September 2010)<br />
For Medicare and Medicaid Determinations Related to States Outside <strong>of</strong> <strong>Nevada</strong>:<br />
Please review Local Coverage Determinations that apply to other states outside <strong>of</strong> <strong>Nevada</strong>:<br />
http://www.cms.hhs.gov/mcd/med/search.<br />
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Important Note: Please also review local carrier Web sites in addition to the Medicare Coverage<br />
database on the Centers for Medicare and Medicaid Service Website.<br />
BACKGROUND<br />
This protocol describes the use <strong>of</strong> balloon catheters during endoscopic sinus surgery for the treatment<br />
<strong>of</strong> chronic sinusitis.<br />
Sinusitis is an inflammation <strong>of</strong> the nasal sinuses, which are hollow cavities in the cheek bones found<br />
around and behind the nose. The inflammation is usually caused by inadequate draining due to allergy,<br />
infection or obstruction. Common symptoms include thick yellowish/green nasal discharge, headache,<br />
feelings <strong>of</strong> facial fullness, congestion, fatigue and fever (Slavin, 2005).<br />
Sinusitis is defined as acute when symptoms last for less than 4 weeks, subacute when lasting 4 to 8<br />
weeks and chronic when lasting for longer than 8 weeks. Physicians diagnose chronic sinusitis based<br />
on symptoms, examination which includes tests such as percussion and transillumination, and other<br />
tests such as x-rays, CT scan or MRI (NIH, 2008).<br />
Initial treatment <strong>of</strong> chronic sinusitis includes antibiotic treatment and possible analgesics, oral<br />
decongestants, nasal sprays and nasally inhaled steroids. If medical therapy fails, then surgery to drain<br />
the sinuses and reduce blockage <strong>of</strong> the nasal passages may be an alternative for treating chronic<br />
sinusitis (NIAID, 2007).<br />
Endoscopic sinus surgery (ESS) is accomplished using fiberoptic technology with an endoscope to<br />
visualize and remove blockages in the sinuses and improve breathing. Complications are uncommon<br />
but can occur during ESS and can include: intraoperative bleeding, scarring and adhesions, orbital<br />
injury and accidental penetration <strong>of</strong> the brain (Patel, 2008). Functional endoscopic sinus surgery<br />
(FESS), a minimally invasive procedure to treat chronic sinusitis, is also used. FESS differs from<br />
traditional sinus surgery in that a thin rigid optical telescope, called an endoscope, is used in the nose<br />
to view the nasal cavity and sinuses. FESS generally eliminates the need for an external incision. The<br />
endoscope allows for better visualization and magnification <strong>of</strong> diseased or problem areas. This<br />
endoscopic exam, along with CT scans, may reveal a problem that was not evident before. The intent<br />
<strong>of</strong> FESS is to widen the sinus passages to restore normal drainage and function. Recently, balloon<br />
dilation catheters have been introduced as an alternative to or adjunctive tool during conventional<br />
FESS (ECRI, 2008).<br />
Balloon sinuplasty is a minimally invasive procedure recently proposed for the treatment <strong>of</strong> chronic<br />
sinusitis, without any need for sinus tissue removal or bone resection. Sinus balloon catheterization is a<br />
surgical technique by which dilation <strong>of</strong> a paranasal sinus ostium is accomplished through use <strong>of</strong> a<br />
balloon catheter. The procedure involves insertion <strong>of</strong> a balloon dilation catheter over a guide-wire<br />
which has been positioned within the involved paranasal sinus under the direction <strong>of</strong> endoscopy and<br />
fluoroscopy. Inflation <strong>of</strong> the balloon results in dilation <strong>of</strong> the targeted ostium (AAO-HNS). Advantages<br />
<strong>of</strong> sinus balloon catheterization include minimal mucosal damage, minimal intraoperative bleeding and<br />
minimal discomfort (Brown, 2006). Balloon sinuplasty using balloon dilation catheters has been<br />
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proposed for patients with chronic sinusitis who have failed antibiotic therapy, topical steroids and<br />
allergic management as demonstrated by an abnormal CT scan (Friedman, 2006).<br />
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CLINICAL EVIDENCE<br />
There are limited studies <strong>of</strong> published, peer reviewed literature available evaluating the outcome <strong>of</strong><br />
patients undergoing the use <strong>of</strong> balloon dilation catheters during endoscopic sinus surgery or balloon<br />
sinuplasty.<br />
In a manufacturer sponsored, multi-center review, Levine et al. (with declared affiliation) conducted a<br />
standardized retrospective chart review <strong>of</strong> 1,036 patients (3,276 sinuses) having functional endoscopic<br />
sinus surgery that included the use <strong>of</strong> balloon catheter instruments (Levine, 2008). All <strong>of</strong> the patients<br />
had a diagnosis <strong>of</strong> chronic sinusitis unresponsive to medical management and who had undergone<br />
endoscopic sinus surgery. There were no exclusion criteria except that the participant was at least 18<br />
years <strong>of</strong> age with a median age <strong>of</strong> 47. Sinus guide catheters, sinus guide wires, and sinus balloon<br />
catheters (from a single manufacturer, Acclarent) were used in the study. Patients were followed for an<br />
average <strong>of</strong> 40.2 weeks. Balloon catheters were used widely across the maxillary, frontal, and sphenoid<br />
sinuses. The revision rate was 1.3% <strong>of</strong> sinuses treated with balloon catheters. Of the patients treated<br />
with balloon catheters, 95.5% reported improvement <strong>of</strong> their sinus symptoms. In addition, 73.8% <strong>of</strong><br />
patients were free <strong>of</strong> sinus infections in the follow-up period after treatment with balloon catheters. No<br />
major adverse events attributed to the balloon catheter were reported. The authors conclude that the use<br />
<strong>of</strong> balloon catheters to treat patients with chronic sinusitis appears to be relatively safe and effective.<br />
This analysis is flawed by its retrospective nature, lack <strong>of</strong> long-term follow-up, lack <strong>of</strong> identified<br />
patient selection criteria and the author's financial conflict <strong>of</strong> interest.<br />
A NICE guidance document states that the current evidence on the short-term efficacy <strong>of</strong> balloon<br />
catheter dilation <strong>of</strong> paranasal sinus ostia for chronic sinusitis is adequate and raises no major safety<br />
concerns. Publication <strong>of</strong> long-term outcomes will be helpful in guiding the future use <strong>of</strong> this technique<br />
(NICE, 2008).<br />
Bolger et al. (2007) conducted a prospective, uncontrolled multi-center study <strong>of</strong> 115 patients to<br />
evaluate the safety and efficacy <strong>of</strong> balloon catheter sinusotomy. Patients enrolled in the study were 18<br />
years or older with a mean age <strong>of</strong> 47.8 years. Patients with extensive sinonasal polyps, extensive<br />
previous sinonasal surgery, extensive sinonasal osteoneogenesis, cystic fibrosis, sinonasal tumors,<br />
history <strong>of</strong> facial trauma that distorted sinus anatomy, ciliary dysfunction, and pregnancy were excluded<br />
from the study. During a 24 week follow-up, complication rates, patency, and sinus symptoms (Sino-<br />
Nasal Outcome Test or SNOT and patient questionnaire) were evaluated. Of the 115 patients, 109<br />
patients (358 sinuses) completed the study. At the end <strong>of</strong> the 24 week follow-up, endoscopy<br />
demonstrated that 80.5% <strong>of</strong> all sinuses were patent, 1.6% were nonpatent, and patency could not be<br />
evaluated in 17.9% <strong>of</strong> sinuses. Based on the patient questionnaire, 83%, 96%, and 84% <strong>of</strong> patients<br />
reported improved sinus symptoms at weeks 1, 12, and 24, respectively. These rates were similar for<br />
patients who underwent balloon catheter sinusotomy (85%, 98%, 80%) and for patients who<br />
underwent concurrent endoscopic surgery <strong>of</strong> different sinuses (80%, 94%, 88%). Sinus symptoms also<br />
improved based on SNOT 20 scores. There were no serious complications; however, 9 patients<br />
experienced bacterial sinusitis postdilation that resolved with oral antibiotic treatment and revision<br />
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treatment was required in 3 sinuses. Device malfunction occurred in 12 <strong>of</strong> 358 sinuses. Based on these<br />
results, the authors conclude that balloon catheter technology appears safe and effective in relieving<br />
ostial obstruction. This study is flawed by the lack <strong>of</strong> randomization and lack <strong>of</strong> long-term follow up.<br />
In addition, postdilatation bacterial sinusitis is a serious complication. This study was extended by<br />
Kuhn et al. (2008), who performed 1-year follow-up examinations on 66 patients and 202 sinuses. At<br />
this point, 172 (85%) sinuses were patent, 2 (1%) were nonpatent, and 28 (14%) could not be<br />
evaluated. Further follow-up data were obtained by Weiss et al. (2008) who reported that, for 61<br />
available patients assessed 2 years after treatment, mean SNOT-20 symptoms scores decreased from<br />
2.2 at baseline to 0.9 and mean Lund-MacKay computed tomography (CT) sinusitis scores decreased<br />
from 10.2 at baseline to 2.7 (P
• In a group <strong>of</strong> selected patients, the use <strong>of</strong> balloon catheter dilation technology alone may<br />
eliminate the need for other surgical techniques.<br />
• Endoscopic balloon catheter dilation as a tool for dilating the opening <strong>of</strong> the maxillary<br />
sphenoid, and frontal sinuses is not investigational or experimental and should not be viewed as<br />
such (ARS, 2007).<br />
The American Rhinologic Society also endorses the AAO-HNS position statements regarding<br />
endoscopic balloon catheter dilation.<br />
Additional search terms<br />
balloon catheter dilatation, chronic rhinosinusitis, FEDS, recurrent sinusitis, sinus infection, rhinology,<br />
sinus balloon dilatation, sinus balloon dilation, sinus surgery<br />
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U.S. FOOD AND DRUG ADMINISTRATION (FDA)<br />
ExploraMed II, Inc. received 501(k) approval for the Relieva Sinus Balloon Catheter on April 5, 2005.<br />
This device is intended to provide a means to dilate the ostia and spaces within the paranasal sinus<br />
cavities for diagnostic and therapeutic procedures. Additional information available at:<br />
http://www.fda.gov/cdrh/pdf4/k043527.pdf.<br />
Acclarent, Inc. received FDA approval for the Relieva Sinus Catheter and the Relieva Sinus Guidewire<br />
on August 18, 2006. This device is intended to provide a means to access the sinus space and to dilate<br />
the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.<br />
Additional information is available at: http://www.fda.gov/cdrh/pdf6/K061903.pdf.<br />
Entellus Medical, Inc. received FDA approval for the Entellus Medical RS-Series System on April 8,<br />
2008. This device is intended to access and treat the maxillary sinus ostium and the ethmoid<br />
infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by<br />
balloon displacement <strong>of</strong> adjacent bone and paranasal sinus structures. A modification was approved on<br />
June 27, 2008 to change the tradename to FinESS Sinus Treatment. Additional information available<br />
at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081542.pdf.<br />
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APPLICABLE CODES<br />
The Current Procedural Terminology (CPT) codes and HCPCS codes listed in this policy are for<br />
reference purposes only. Listing <strong>of</strong> a service code in this policy does not imply that the service<br />
described by this code is a covered or non-covered health service. Coverage is determined by the<br />
benefit document.<br />
CPT Codes<br />
31299 Unlisted procedure, accessory sinuses<br />
HCPC Codes<br />
S2344<br />
Coding Clarification<br />
Nasal/sinus endoscopy, surgical; with enlargement <strong>of</strong> sinus ostium opening<br />
using inflatable device (i.e., balloon sinuplasty)<br />
Balloon sinuplasty may be reported with unlisted code 31299 or S2344. Operative reports may be<br />
needed to determine if balloon sinus dilatation was performed.<br />
REFERENCES<br />
Acclarent website. Available at: http://www.acclarent.com/.<br />
American Academy <strong>of</strong> Otolaryngology - Head and Neck Surgery (AAO-HNS). Sinus Balloon<br />
Catheterization Position Statement. March 2007. Available at:<br />
http://www.entnet.org/Practice/policySinusBalloonCatheterization.cfm.<br />
American Rhinologic Society Position Statement on Endoscopic Balloon Catheter Sinus Dilation<br />
Technology (Balloon Sinuplasty). May 2007. Available at: http://www.americanrhinologic.<br />
org/patientadvocacy.balloon.phtml.<br />
Bolger WE, Brown CL, Church CA, et al. Safety and outcomes <strong>of</strong> balloon catheter sinusotomy: a<br />
multicenter 24-week analysis in 115 patients. Otolaryngol Head Neck Surg. 2007;137(1):10-20.<br />
Brown C, Bolger W. Safety and Feasibility <strong>of</strong> Balloon Catherter Dilation <strong>of</strong> Paranasal Sinus Ostia:A<br />
Preliminary Investigation. Annals <strong>of</strong> Otology, Rhinology & Laryngology. 2006:115(4):293-299.<br />
Chandra, R. Estimate <strong>of</strong> radiation dose to the lens in balloon sinuplasty. Otolaryngology head and<br />
Neck Surg. 2007;137(6):953-955.<br />
CRI Institute. Emerging Technology Report. Balloon catheter dilation for chronic sinusitis. December<br />
2008. Entellus Medical website. Available at: http://www.entellusmedical.com/.<br />
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Friedman M, Schalch P. Functional endoscopic dilatation <strong>of</strong> the sinuses (FEDS): Patient selection and<br />
surgical technique. Operative Techniques in Otolaryngology Head and Neck Surgery. 2006:17 (2):126-<br />
134.<br />
Hayes, Inc. <strong>Health</strong> Technology Brief. Relieva balloon sinuplasty (Acclarent Inc.) for treatment <strong>of</strong><br />
chronic sinusitis. Lansdale, PA: Hayes, Inc.; November 2008.<br />
Kuhn FA, Church CA, Goldberg AN, et al. Balloon catheter sinusotomy: one-year follow-up--<br />
outcomes and role in functional endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2008<br />
Sep;139(3 Suppl 3):S27-37.<br />
Levine H, Sertich A, Hoisington D, Weiss R, Pritikin J. Multicenter Registry <strong>of</strong> Balloon Catheter<br />
Sinusotomy Outcomes for 1,036 Patients. Annals <strong>of</strong> Otology, Rhinology & Laryngology. 2008;117<br />
(4):263-270.<br />
National Institute <strong>of</strong> Allergy and Infectious Diseases (NIAID). Sinus Infection (Sinusitis). Last updated<br />
August 2007. Available at: http://www3.niaid.nih.gov/healthscience/healthtopics/sinus/.<br />
National Institutes <strong>of</strong> <strong>Health</strong> (NIH). Medline Plus Medical Encyclopedia. Sinusitis - Chronic. January<br />
30, 2008. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000677.htm.<br />
NICE. IPG 273 Balloon catheter dilation <strong>of</strong> paranasal sinus ostia for chronic sinusitis. September 2008.<br />
Available at: http://www.nice.org.uk/nicemedia/pdf/IPG273Guidance.pdf.<br />
Patel, Ankit. Functional Endoscopic Sinus Surgery. eMedicine. March 6, 2008. Available at:<br />
http://www.emedicine.com/ent/TOPIC758.HTM#section~Complications.<br />
Slavin R, Spector S, Bernstein I. The diagnosis and management <strong>of</strong> sinusitis: A practice parameter<br />
update. Journal <strong>of</strong> Allergy and Clinical Immunology. November 2005. Available at:<br />
http://www.jacionline.org/webfiles/images/journals/ymai/5512.pdf.<br />
Weiss RL, Church CA, Kuhn FA, et al. Long-term outcome analysis <strong>of</strong> balloon catheter sinusotomy:<br />
two-year follow-up. Otolaryngol Head Neck Surg. 2008 Sep;139(3 Suppl 3):S38-46.<br />
PROTOCOL HISTORY/REVISION INFORMATION<br />
Date<br />
Retired 11/13/2009<br />
09/23/2010<br />
09/25/2009<br />
Action/Description<br />
Medical Technology Assessment Committee<br />
Corporate Medical Affairs Committee<br />
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