Medical Policy: 07.01.31
Original Effective Date: May 2006
Reviewed: October 2020
Revised: October 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy 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 will be reviewed regularly and be updated as scientific and medical literature becomes available.
Rhinosinusitis (ARS): ARS is a clinical condition characterized by inflammation of the mucosa of the nose and paranasal sinuses with associated sudden onset of symptoms of purulent nasal drainage accompanied by nasal obstruction, facial pain/pressure/fullness, or both of up to 4 weeks.
Chronic Rhinosinusitis (CRS): An inflammatory process that involves the paranasal sinuses and persists for longer than 12 weeks. Chronic rhinosinusitis (CRS) is characterized by purulent nasal discharge, usually without fever. Symptoms of congestion often accompany the nasal discharge. There also may be mild pain and/or a headache. Thickening of mucosa may restrict or close natural openings between sinus cavities and the nasal fossae, although symptoms vary considerably because of the location and shape of these sinus ostia.
Recurrent Acute Rhinosinusitis (RARS): RARS is defined as four episodes per year of acute rhinosinusitis with distinct symptom free intervals between episodes.
Most cases of CRS and RARS are treated with medical therapy (e.g., antihistamines, steroids, nasal lavage, and antibiotics).
Functional endoscopic dilation of the sinuses, also referred to as Balloon SinuplastyTM or Balloon ostial dialation (BOD) describes a procedure intended to clear sinus cavities using a balloon rather than invasive surgery. During this endoscopic procedure, a catheter-based device is advanced into the sinus under fluoroscopic guidance. Once positioned the balloon is gradually inflated to open the sinus thereby allowing drainage.
In a typical FESS (functional endoscopic sinus surgery), the physician first identifies the middle turbinate and removes the uncinate process to expose the ethmoid bulla. The anterior ethmoid air cells are opened, leaving the bone covered with mucosa. This allows for better ventilation of the anterior ethmoid sinuses. The maxillary ostium is examined and, if it is obstructed, a middle meatal antrostomy is performed. This minimal surgery is often sufficient to improve the function of the osteomeatal complex, which improves the ventilation of the maxillary, ethmoid, and frontal sinuses.
Balloon sinuplasty is frequently used within the FESS procedure as a tool to open the sinuses, enabling the surgeon better access with the endoscope. Balloon sinuplasty as part of sinus surgery is considered a tool and therefore inherent to the procedure and not available for additional payment.
A 2008 guidance on balloon catheter dilation of paranasal sinus ostia from the National Institute for Health and Care Excellence has stated: “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.” In 2016, the Institute published a recommendation on the use of the XprESS Multi-Sinus Dilation System for the treatment of chronic rhinosinusitis:
1.1 "The case for adopting the XprESS multi-sinus dilation system for treating uncomplicated chronic sinusitis after medical treatment has failed is supported by the evidence. Treatment with XprESS leads to a rapid and sustained improvement in chronic symptoms, fewer acute episodes and improved quality of life which is comparable to functional endoscopic sinus surgery (FESS).
1.2 XprESS should be considered in patients with uncomplicated chronic sinusitis who do not have severe nasal polyposis. In these patients, XprESS works as well as FESS, is associated with faster recovery times, and can more often be done under local anaesthesia."
The AAO-HNS (2018) developed a clinical consensus statement on balloon dilation of the paranasal sinuses. The target population included adults ≥ age 18 years with chronic or recurrent rhinosinusitis (with or without nasal polyps, with or without prior sinus surgery) for whom sinus ostial dilation (SOD) was being recommended. SOD was defined as endoscopic use of a balloon device to enlarge or open the outflow tracts of the maxillary, frontal, or sphenoid sinuses, as a standalone procedure or with endoscopic surgery. The use of serial dilations over time in the same patient was not considered. According to AAO-HNS there has been an increasing rate of utilization of SOD without a reduction in the number of traditional functional endoscopic sinus surgeries being performed. Due to limited evidence to support a guideline, the topic of SOD was selected for clinical consensus statement (CCS) development. Based on a systematic review of the literature and expert consensus, the Society’s statements included the following:
A 2014 AAO-HNS Clinical Consensus Statement on Pediatric Chronic Rhinosinusitis had near consensus on the safety of balloon ostial dilation in children but did not reach a consensus on efficacy.
American Academy of Pediatrics Clinical Practice Guidelines only address the diagnosis and treatment of acute bacterial rhinosinusitis.
In a position paper (2017), ARS stated that sinus ostial dilation is an appropriate therapeutic option for selected patients with chronic rhinosinusitis (CRS) and recurrent acute rhinosinusitis (RARS) who have failed appropriate medical therapy. Clinical diagnosis of CRS and RARS should be based on symptoms of sinusitis and supported by nasal endoscopy documenting sinonasal abnormality or mucosal thickening on computed tomography of the paranasal sinuses. This procedure may be used alone to dilate a sinus ostium (frontal, maxillary, or sphenoid) or in conjunction with other instruments (e. g., microdebrider, forceps). The final decision regarding use of techniques or instrumentation for sinus surgery is the responsibility of the attending surgeon.
Sinus stents are defined as implantable devices specifically designed to improve patency and/or deliver local medication. These devices are inserted under endoscopic guidance and are distinguished from sinus packing and variations on packing devices routinely employed after sinus surgery.
A nasal obstruction severity classification system has been developed to determine the severity of nasal obstruction. The system is proposed as a means to classify patients for clinical management as well as to better define study populations and describe treatment or intervention responses.
|Severity Class||NOSE Score Range|
Sinus stents are devices used postoperatively following endoscopic sinus surgery (ESS). These devices are used to maintain patency of the sinus openings in the postoperative period, and/or to serve as a local drug delivery vehicle. Reducing postoperative inflammation and maintaining patency of the sinuses may be important in achieving optimal sinus drainage and may impact recovery from surgery.
Latera™ Absorbable Nasal Implant: This new device from Spirox,™ Inc. (Menlo Park, CA) obtained FDA clearance via the 510(k) approval process in 2016 and is indicated for, "Supporting nasal upper and lower lateral cartilage." This implantable device is proposed to assist in the surgical correction of collapsed nasal wall tissue and possibly improving nasal obstruction.
The Propel® implant was approved through the premarket approval application (PMA) process. The implant is intended “for use in patients >18 years of age following ethmoid sinus surgery to maintain patency. The Propel separates mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces edema.” The implant is manufactured from a synthetic bioabsorbable copolymer, poly (L-lactideco-glycolide) and contains 370 μg mometasone furoate a synthetic corticosteroid. The implant is designed to accommodate the size and variability of the post-surgical ethmoid sinus anatomy. The device is dissolvable over a period of several weeks, and thereby does not require removal.
The Propel Mini® was FDA PMA approved in 2012 as a shortened version of the Propel and is indicated for use in a patient ≥ 18 years of age following ethmoid sinus surgery to maintain patency. The Mini also contains 370 μg mometasone furoate. In 2016, The Propel Mini FDA indication was expanded to include treatment of the frontal sinus. The Propel Contour Sinus Implant was FDA PMA approved in February 2017 as a supplement to the Propel FDA PMA approval. This device is indicated for use in patients ≥ 18 years of age to maintain patency of the frontal and maxillary sinus ostia following sinus surgery. Per Intersect, the Contour has an hourglass shape and is proposed to conform to sinus ostia, propping the sinuses open while delivering the medication. Like the other Propel devices the Contour releases 370 μg mometasone furoate.
Middle meatal spacers are related but separate devices intended to maintain sinus patency post-ESS. They are splint-like devices inserted directly rather than under endoscopic guidance, and do not have the capability of delivering local medication. The products currently include the Relieva Stratus MicroFlow spacer and the Sinu-Foam spacer. Sinu-Foam is an Food and Drug Administration (FDA)-approved mixture, which is commonly mixed with saline and gently placed in the ethmoid cavity following FESS.
In 2017 Sinuva™ (Intersect ENT, Palo Alto, CA) was FDA approved as a drug for implantation for the treatment of nasal polyps in patients who have had ethmoid sinus surgery and have recurrent polyposis. Sinuva contains 1350 mcg of mometasone furoate and is proposed for implantation in the physician’s office and is left in place for 90 days.
There are a number of postoperative treatment regimens, and the optimal regimen is uncertain. Options include saline irrigation, nasal packs, topical steroids, systemic steroids, topical decongestants, oral antibiotics, and/or sinus cavity debridement. A number of RCTs have evaluated various treatment options, but all different strategies have not been rigorously evaluated. A systematic review evaluated the evidence for these therapies. The authors of this review concluded that the evidence was not strong for any of these treatments but that some clinical trial evidence supported improvements in outcomes. The strongest evidence was for use of nasal saline irrigation, topical nasal steroid spray, and sinus cavity debridement.
A 2015 Cochrane review addressed steroid-eluting sinus stents for improving chronic rhinosinusitis symptoms in individuals undergoing ESS. Study eligibility criteria were RCTs that compared the effects of steroid-eluting sinus stents with non-steroid-eluting sinus stents, nasal packing, or no treatment in adults with chronic rhinosinusitis who underwent ESS. None of the studies met authors’ inclusion criteria. The authors concluded that there is no evidence from high-quality RCTs to demonstrate the benefits of steroid-eluting stents.
No clinical practice guidelines were identified that recommend the use of sinus stents, spacers or implants including the 2015 update of the 2007 guideline from the American Academy of Otolaryngology-Head and Neck Surgery Foundation.
FDA labeling for several 510(k) cleared devices includes use in children 17 years of age and under and is indicated to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.
|Device||Manufacturer||510(k) No.||Date Cleared||Indication|
|MESIRE - Balloon Sinus Dilatation System||Meril Life Sciences||K172737||12/12/2017||Sinus Ostia Dilation|
|Relieva UltirraNav Sinus Balloon Catheter||Acclarent Inc.||K161698||10/24/2016||Sinus Ostia Dilation|
|Vent-Os Sinus Dilation Family||Sinusys Corp.||K160770||6/29/2016||Sinus Ostia Dilation|
|Relieva Scout Multi-Sinus Dilation System||Acclarent Inc.||K153341||2/12/2016||Sinus Ostia Dilation|
|XprESS Multi-Sinus Dilation System||Entellus Medical Inc.||K152434||11/20/2015||Sinus Ostia Dilation|
|DSS Sinusplasty Balloon Catheter||Intuit Medical Products LLC||K143738||8/27/2015||Sinus Ostia Dilation|
|Relieva SpinPlus Balloon Sinuplasty System||Acclarent Inc.||K143541||4/22/2015||Sinus Ostia Dilation|
|XprESS Multi-Sinus Dilation Tool||Entellus Medical Inc.||K142252||10/17/2014||Sinus Ostia Dilation|
|Relieva Scout Multi-Sinus Dilation System||Acclarent Inc.||K140160||2/20/2014||Sinus Ostia Dilation|
Sinus Stents and Spacers
In early 2014, the U.S. Food and Drug Administration (FDA) granted 510k clearance to the SinuSys Vent-OS Sinus Dilation System for dilation of the maxillary sinus ostia and associated spaces in adults.
Propel Mini FDA indication was expanded to include treatment of the frontal sinus. The Propel Contour Sinus Implant was FDA PMA approved in February 2017 as a supplement to the Propel FDA PMA approval.
In 2017 Sinuva™ (Intersect ENT, Palo Alto, CA) was FDA approved as a drug for implantation for the treatment of nasal polyps in patients who have had ethmoid sinus surgery and have recurrent polyposis.
Latera™ Absorbable Nasal Implant: This new device from Spirox,™ Inc. (Menlo Park, CA) obtained FDA clearance via the 510(k) approval process in 2016 and is indicated for, "Supporting nasal upper and lower lateral cartilage."
Use of a catheter-based inflatable device (balloon ostial dilation) for the treatment of chronic rhinosinusitis in the frontal, maxillary, or sphenoid sinus being considered for dilation may be medically necessary when the following criteria are present:
Patient is 17 years of age or older AND
Diagnosed with Chronic rhinosinusitis without nasal polyps, characterized by at least two of the following, at least one of which is (1) or (2), present for at least 12 continuous weeks:
Optimal medical therapy has been attempted and failed, as indicated by all of the following:
Clinical and radiographic documentation of persistent inflammation following optimal medical therapy (see Policy Guidelines).
The use of Balloon Sinuplasty/Endoscopic Dilatation of the Sinuses/Balloon Ostial Dilation (BOD) for all other indications is investigational including but limited to the following:
Inflammation should be documented by all of the following:
Balloon Sinuplasty/Endoscopic Dilatation of the Sinuses/Balloon Ostial Dilation (BOD) when used as a tool during functional endoscopic sinus surgery (FESS) in the same sinus cavity is considered to be an integral part of the FESS procedure.
When Balloon Sinuplasty/Endoscopic Dilatation of the Sinuses/Balloon Ostial Dilation (BOD) is used as an adjunct to FESS (defined as FESS on one sinus and BOD on another sinus in the same patient during the same operation) medical necessity criteria for BOD apply to the sinus being considered for BOD.
The use of implantable sinus stents, sinus implants, and sinus spacers (e,g, Sinuva, Latera, Propel, Propel mini, SinuSys Vent-OS Sinus Dilation System) for all indications, including but not limited to postoperative treatment following endoscopic sinus surgery and for treatment of recurrent nasal polyposis is considered investigational.
Sinus stents/implants may prove to have a role in nasal polyposis; however, additional positive results from well-designed RCTs are needed to confirm the results of the single available RCT. There is a lack of guidance in national guidelines that recommend the use of sinus stents in all populations. At this time, there are no well-designed, full-text published studies in the peer-reviewed literature addressing the devices listed. Until such time there is sufficient data available, the safety and efficacy of this technology is uncertain.
The studies available for stents/implants after sinus surgery have limitations, including risk of bias. In addition, because of the comparison group used in these trials primarily evaluate the efficacy of topical steroids when delivered by an implanted device, but do not evaluate the efficacy of the device versus standard care or standard dosing. The evidence is insufficient to determine the effects of the technology on health outcomes.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
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