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DESCRIPTIONSinus stents are devices that are 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.
Endoscopic surgery (ESS) is typically performed in patients with chronic rhinosinusitis unresponsive to conservative treatment. The surgery is associated with high rates of improvement in up to 90% of more appropriately selected patients. However, there are no high-quality randomized controlled trials (RCTs) comparing functional ESS to continued medical management or alternative treatment approaches. Because of the high success rates and minimally invasive approach, these procedures have rapidly increased in frequency, with an estimated 250,000 procedures performed annually in the U.S. They can be done either in the physician’s office under local anesthesia or in the hospital setting under general anesthesia.
ESS involves the removal of small pieces of bone, polyps, and debridement of tissue within the sinus cavities. There are a number of variations on the specific approach, depending on the disorders being treated and the preferences of the treating surgeon. For all procedures, there is a substantial postoperative inflammation and swelling, and postoperative care is therefore a crucial component of ESS.
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 randomized controlled trials (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.
Some form of sinus packing is generally performed postoperatively. Simple dressings moistened with saline can be inserted manually following surgery. Foam dressings are polysaccharide substances that form a gel when hydrated and can be used as nasal packs for a variety of indications. Middle meatal spacers are splint-like devices that prop open the sinus cavities post-ESS, but are not capable of drug delivery. There is some RCT evidence that middle meatal spacers may reduce the formation of synechiae following ESS, although the available studies have significant heterogeneity in this outcome.
Implantable sinus stents are another option for postoperative management following ESS. These implants are intended to stabilize the sinus openings and the turbinates, reduce edema, and/or prevent obstruction by adhesions. They can also be infused with medication delivered topically over an extended period of time, and this local delivery of medications may be superior to topical application in the postoperative setting.
The PROPEL™ system (Intersect ENT, Palo Alto, CA) was granted U.S. Food and Drug Administration (FDA) approval under the premarketing approval (PMA) program in August 2011. This device is a self-expanding, bioabsorbable, steroid-eluting stent that is intended for use in the ethmoid sinus. It is placed via endoscopic guidance using a plunger included with the device. Steroids (mometasone furoate) are embedded in a polyethylene glycol polymer, which allows sustained release of the drug over an approximate duration of 30 days. The device dissolves over a period of several weeks, and therefore does not require removal. In September 2012, a smaller version of the PROPEL device, the PROPEL mini Sinus Implant, was approved for use in patients older than age 18 years following ethmoid sinus surgery.
In October 2011, the Relieva Stratus™ MicroFlow spacer, a balloon-based device that acts as a spacer and medication delivery system, was cleared for marketing by FDA through the 510(k) program for use postoperatively to maintain an opening to the sinuses for the first 14 days postoperatively. It is placed via a catheter under endoscopic guidance. This device is temporary and requires manual removal after 30 days, with implantation of a new device if needed. It is approved for infusion with saline, but not for use with other medications such as steroids. This device is no longer marketed in the U.S.
POLICYThe use of implantable sinus stents for postoperative treatment following endoscopic sinus surgery and for treatment of recurrent sinonasal polyposis is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Sinus stents are defined as implantable devices that are specifically designed to improve patency and/or deliver local medication. These are inserted under endoscopic guidance and are distinguished from sinus packing and variations on packing devices routinely employed after sinus surgery.
Foam dressings, such as SinuFoam™, are used as nasal packs for a variety of conditions, including nosebleeds, and have also been used after endoscopic sinus surgery. These are considered different types of nasal packing.
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.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY11/15/2012: Approved by Medical Policy Advisory Committee.
03/10/2014: Policy reviewed; description updated regarding available devices. Policy statement unchanged.
12/19/2014: Policy title changed from "Implantable Sinus Spacers and Stents for Postoperative Use Following Endoscopic Sinus Surgery" to "Implantable Sinus Stents for Postoperative Use Following Endoscopic Sinus Surgery." Policy description updated regarding devices. Policy statement updated to remove "spacers."
07/30/2015: Code Reference section updated for ICD-10.
04/25/2016: Policy title updated to add "and for Recurrent Sinus Disease." Policy description updated. Policy statement updated to add "for treatment of recurrent sinonasal polyposis" as investigational. Policy Guidelines section updated regarding sinus stents and to revise the investigative definition.
05/31/2016: Policy number A.7.01.134 added.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.134
This may not be a comprehensive list of procedure codes applicable to this policy.
Mometasone furoate sinus implant, 370 micrograms
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