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A.7.01.134
Steroid-eluting sinus stents are devices used postoperatively following endoscopic sinus surgery (ESS) or for treatment of recurrent sinonasal polyposis following ESS. These devices maintain patency of the sinus openings in the postoperative period, and/or 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 and/or reduce the need for additional surgery.
Chronic Rhinosinusitis
Chronic rhinosinusitis is an inflammatory sinus condition that has a prevalence between 1% and 5% in the U.S. population.
Treatment
Endoscopic sinus surgery (ESS) is typically performed on 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 comparing functional ESS with 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 United States. 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 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 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. Several randomized controlled trials have evaluated treatment options, but not all strategies have been rigorously evaluated. A systematic review has evaluated the evidence for these therapies. Reviewers 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 supported 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 designed for drug delivery. There is some randomized controlled trial evidence that middle meatal spacers may reduce the formation of synechiae following ESS, although the available studies have significant heterogeneity in this outcome.
Sinus Stents and Implants
Implantable sinus stents and implants 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.
In 2011, the PROPEL® system (Intersect ENT, Menlo Park, CA) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process. This device is a self-expanding, bioabsorbable, steroid-eluting stent intended for use in the ethmoid sinus. It is placed via endoscopic guidance using a plunger included with the device. Steroids (mometasone furoate) are released over an approximate duration of 30 days. The device dissolves over several weeks, and therefore does not require removal. In 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 to maintain patency. In 2017, the PROPEL Contour was approved through a premarket approval supplement. The PROPEL Contour sinus implant is an adaptable implant that is designed to maximize drug delivery to the frontal and maxillary sinus.
SINUVA™ Sinus Implant (Intersect ENT, Inc., Menlo Park, CA) was initially approved in 1987. In 2017, the SINUVA Sinus Implant was approved with a new dose (1350 μg mometasone furoate) under a New Drug Application (NDA 209310). The corticosteroid is released over 90 days and the bioabsorbable polymers soften over this time. The implant is removed at Day 90 or earlier using standard surgical instruments. The SINUVA™ Sinus Implant is indicated for the treatment of nasal polyps in adult patients who have had ethmoid sinus surgery.
The use of steroid-eluting sinus stents and implants for postoperative treatment following endoscopic sinus surgery and for treatment of recurrent sinonasal polyposis is considered investigational.
The use of steroid-eluting sinus stents and implants is considered investigational in all other conditions.
Federal 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 specifically designed to improve patency and/or deliver local medication. These devices areinserted 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. They are considered different types of nasal packing.
Middle meatal spacers are related but separate devices intended to maintain sinus patency post-endoscopic sinus surgery. 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.
11/15/2012: 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.
04/26/2017: Policy reviewed. Policy statement unchanged. Code Reference section updated to add CPT codes 0406T and 0407T.
03/07/2018: Policy description updated regarding chronic rhinosinusitis and devices. Policy statement unchanged.
12/27/2018: Code Reference section updated to make note of deleted CPT codes 0406T and 0407T, effective 12/31/2018.
08/01/2019: Policy title changed from "Implantable Sinus Stents for Postoperative Use Following Endoscopic Sinus Surgery and for Recurrent Sinus Disease" to "Steroid-Eluting Sinus Stents." Policy description updated regarding intraoperative and postoperative steroid-eluting sinus stents. Policy statement updated to change "implantable sinus stents" to "steroid-eluting sinus stents." Added statement that the use of drug-eluting sinus stents is considered investigational in all other conditions. Code Reference section updated to add CPT code 31299.
09/17/2019: Code Reference section updated to add new HCPCS code J7401, effective 10/01/2019.
03/11/2020: Policy reviewed. Policy statements unchanged. Code Reference section updated to remove deleted CPT codes 0406T and 0407T.
06/26/2020: Code Reference section updated to add new HCPCS code C9122, effective 07/01/2020.
03/30/2021: Code Reference section updated to add new HCPCS code J7402, effective 04/01/2021. Removed deleted HCPCS code S1090.
03/24/2022: Policy title changed from "Steroid-Eluting Sinus Stents" to "Steroid-Eluting Sinus Stents and Implants." Policy description and policy statements updated to include "implants" for consistency with policy title. Code Reference section updated to add HCPCS code S1091.
03/20/2023: Policy description updated. Policy statements unchanged. Code Reference section updated to remove deleted HCPCS codes C9122 and J7401.
03/21/2024: Policy reviewed; no changes.
04/10/2025: Policy reviewed; no changes.
Blue Cross Blue Shield Association policy # 7.01.134
Code Number | Description |
CPT-4 | |
31299 | Unlisted procedure, accessory sinuses |
HCPCS | |
J7402 | Mometasone furoate sinus implant, (sinuva), 10 micrograms |
S1091 | Stent, non-coronary, temporary, with delivery system (propel) |
ICD-10 Procedure | |
ICD-10 Diagnosis |
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