Latest Review Date: June 2024

Category: Medical                                     

POLICY:

The use of steroid-eluting stents and implants are considered investigational for the following, including, but not limited to:

• Postoperative treatment following endoscopic sinus surgery;
• For treatment of recurrent sinonasal polyposis.

DESCRIPTION OF PROCEDURE OR SERVICE:

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 prevalence between 1% and 5% in the U.S. population.

Treatment

Endoscopic sinus surgery (ESS) is typically performed in individuls with chronic rhinosinusitis unresponsive to conservative treatment. The surgery is associated with improvements in symptoms in up to 90% of more appropriately selected patients. However, there are no high-quality 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 that are being treated and the preferences of the treating surgeon. For all procedures, there is a substantial amount of 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 not certain. Options include saline irrigation, nasal packs, topical steroids, systemic steroids, topical decongestants, oral antibiotics, and/or sinus cavity debridement. There have been a number of randomized controlled trials (RCTs) that have evaluated various treatment options, but all different strategies have not been rigorously evaluated. A systematic review 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 RCT 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 drug eluting 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 also have the capability of being infused with medication that can be delivered topically over an extended period of time, and this local delivery of medications may be superior to topical application in the postoperative setting.

Foam dressings, such as SinuFoam™, are used as nasal packs for a variety of conditions, including nosebleeds, and have also been used post-ESS. These are considered different types of nasal packing.

Middle meatal spacers are related but separate devices that are intended to maintain sinus patency post-ESS. They are splint-like devices that are inserted directly rather than under endoscopic guidance, and they do not have the capability of delivering local medication.

KEY POINTS:

The most recent literature search was performed through June 15, 2024. The following is a summary of the key findings to date.

Summary of Evidence:

For individuals who have chronic rhinosinusitis who have undergone endoscopic sinus surgery (ESS) who receive implantable steroid-eluting sinus stents, the evidence includes randomized controlled trials (RCTs). Relevant outcomes are symptoms, change in disease status, morbid events, and treatment-related morbidity. The most direct evidence relating to use of steroid-eluting nasal stents as an adjunct to ESS comes from 4 RCTs comparing steroid-eluting stents with either a non-steroid-eluting stent or medical management. The need for post-operative intervention at 30 days was reduced by 14% to 24%, translating to a number needed to treat of 4.7 or more. Three trials used blinded assessors to evaluate post-implantation sinus changes, an important strength, but the trials had potentials for bias. To evaluate the benefit most accurately from PROPEL devices it is important to ensure that the comparison group is not undertreated (i.e., receives some form of packing, intranasal steroids, and irrigation). The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have recurrent sinonasal polyposis who have undergone ESS who receive steroid-eluting sinus implants, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, and treatment-related morbidity. Two RCTs were identified evaluating the use of steroid-eluting nasal implants for recurrent or persistent nasal polyposis after ESS, which demonstrated improvements in polyp grade and ethmoid obstruction. Strengths of these trials included use of sham control and adequate power for its primary outcome. However, the trials had a high-risk of bias due to unblinded outcome assessment. Although avoidance of repeat ESS and oral steroids may be relevant outcomes for this indication, it would be more important if decisions about repeat ESS or other treatments were standardized and, in the trial setting, if decisions were prespecified or made by a clinician blinded to treatment group. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements:

American Academy of Otolaryngology-Head and Neck Surgery

In 2023, the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) issued a position statement on the use of drug-eluting sinus implants for the management of mucosal inflammation of the paranasal sinuses. This statement was not based on a systematic review of the evidence.

"The AAO-HNS considers drug-eluting implants in the paranasal sinuses as a proven and effective therapeutic option for mucosal inflammation."

The recommendation states, "Multiple studies have demonstrated the efficacy and safety of drug-eluting implants in controlling sinonasal inflammation. Clinical evidence regarding the use of drug-eluting implants after sinus surgery has particularly shown enhanced wound healing through the reduction of both scar formation and anatomic obstruction."

American Rhinologic Society

In 2023, the American Rhinololgic Society (ARS) issued a position statement on the utilization of drug-eluting implants into the sinus cavities. This position statement was not based on a systematic review of the evidence.:

"ARS feels strongly that drug-eluting implants should in no way be considered investigational and should be available to patients, when selected by the physician, in order to maximize outcomes."

The recommendation notes, "There continues to be a growing level of high-quality evidence on the safety and efficacy of drug-eluting implants in the paranasal sinuses. These studies have demonstrated cost effectiveness as well as improvement of patient centered outcomes by reducing inflammation, maintaining ostial patency, decreasing scarring, and preventing middle turbinate lateralization while limiting the need for administration of oral steroids..."

International Consensus Statement on Allergy and Rhinology

In 2021, the International Consensus Statement on Allergy and Rhinology was updated and included the following recommendation:

"Corticosteroid-eluting implants can be considered as an option in a previously operated ethmoid cavity with recurrent nasal polyposis."

The recommendation noted, "Corticosteroid eluting implants have been shown to have beneficial impact on ethmoid polyposis and obstruction, and 1 study has shown them to be cost-effective in preventing revision ESS. Experience is early and although evidence is high level, only short-term outcomes are currently available."

U.S. Preventive Services Task Force Recommendations:

Not applicable.

KEY WORDS:

Implantable sinus stents, implantable sinus spacers, PROPEL™, Relieva Stratus™ MicroFlow spacer, Mometasone furoate sinus implant, Sinu-Foam spacer, Sinuva (mometasone furoate), sinus implant, Intersect ENT, nasal polyp, ethmoid sinus surgery

APPROVED BY GOVERNING BODIES:

Intraoperative Steroid-Eluting Sinus Stents

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 (P100044). 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 PMA 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.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING:

CPT Codes:

HCPCS Codes:

REFERENCES:

1. American Academy of Otolaryngology-Head and Neck Surgery. Position Statement: Drug-Eluting Sinus Implants. January 17, 2023; https://www.entnet.org/resource/position-statement-eluting-implants/.
2. American Rhinologic Society. ARS Position Statement: Criteria for Drug-Eluting Implants. January 28, 2023; https://www.entnet.org/resource/position-statement-eluting-implants/. 
3. Berlucchi M, Castelnuovo P, Vincenzi A, et al. Endoscopic outcomes of resorbable nasal packing after functional endoscopic sinus surgery: a multicenter prospective randomized controlled study. Eur Arch Otorhinolaryngol. Jun 2009; 266(6): 839-45.
4. Côté DW, Wright ED. Triamcinolone-impregnated nasal dressing following endoscopic sinus surgery: a randomized, double-blind, placebo-controlled study. Laryngoscope. Jun 2010; 120(6): 1269-73
5. Forwith KD, Han JK, Stolovitzky JP, et al. RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. Int Forum Allergy Rhinol. 2016; 6: 573-581.
6. Freeman SR, Sivayoham ES, Jepson K, et al. A preliminary randomised controlled trial evaluating the efficacy of saline douching following endoscopic sinus surgery. Clin Otolaryngol. Oct 2008; 33(5): 462-5.
7. Goshtasbi K, Abouzari M, Abiri A, Yasaka T, Sahyouni R, Bitner B, Tajudeen BA, Kuan EC. Efficacy of steroid-eluting stents in management of chronic rhinosinusitis after endoscopic sinus surgery: updated meta-analysis. Int Forum Allergy Rhinol. 2019 Dec;9(12):1443-1450. doi: 10.1002/alr.22443. Epub 2019 Sep 20. 
8. Han JK, Marple BF, Smith TL. Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis. Int Forum Allergy Rhinol 2012; 2(4):271-9. https://www.sinuva.com/.
9. Han JK, Forwith KD, Smith TL, et al. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. Nov 2014; 4(11):861-870.
10. Huang Z, Hwang P, Sun Y, et al. Steroid-eluting sinus stents for improving symptoms in chronic rhinosinusitis patients undergoing functional endoscopic sinus surgery. Cochrane Database Syst Rev. 2015; 6:CD010436.
11. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
12. Kern, RR, Stolovitzky, JJ, Silvers, SS, Singh, AA, Lee, JJ, Yen, DD, Iloreta, AA, Langford, FF, Karanfilov, BB, Matheny, KK, Stambaugh, JJ, Gawlicka, AA. A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps. Int Forum Allergy Rhinol, 2018 Jan 20;8(4).
13. Kern RC, Stolovitzky JP, Silvers SL, et al; RESOLVE II study investigators. A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps. Int Forum Allergy Rhinol. 2018;8(4):471-481.
14. Lee JM, Grewal A. Middle meatal spacers for the prevention of synechiae following endoscopic sinus surgery: a systematic review and meta-analysis of randomized controlled trials. Int Forum Allergy Rhinol 2012; 2(6): 477-486.
15. Luong, AA, Ow, RR, Singh, AA, Weiss, RR, Han, JJ, Gerencer, RR, Stolovitzky, JJ, Stambaugh, JJ, Raman, AA. Safety and Effectiveness of a Bioabsorbable Steroid-Releasing Implant for the Paranasal Sinus Ostia: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg, 2017 Nov 4.
16. Marple BF, Smith TL, Han JK et al. Advance II: a prospective, randomized study assessing safety and efficacy of bioabsorbable steroid-releasing sinus implants. Otolaryngol. Head Neck Surg. 2012; 146(6):1004-11.
17. Murr AH, Smith TL, Hwang PH, et al. Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent. Int Forum Allergy Rhinol. 2011; 1(1): 23-32.
18. Orlandi RR, Kingdom TT, Smith TL, et al. International consensus statement on allergy and rhinology: rhinosinusitis 2021. Int Forum Allergy Rhinol. Mar 2021; 11(3): 213-739.
19. Rotenberg BW, Zhang I, Arra I, et al. Postoperative care for Samter's triad patients undergoing endoscopic sinus surgery: a double-blinded, randomized controlled trial. Laryngoscope. Dec 2011; 121(12): 2702-5.
20. Rudmik L, Mace J, Mechor B. Effect of a dexamethasone Sinu-Foam™ middle meatal spacer on endoscopic sinus surgery outcomes: a randomized, double-blind, placebo-controlled trial. Int Forum Allergy Rhinol. Jan 17 2012;2(3):248-251.
21. Rudmik L, Soler ZM, Orlandi RR, et al. Early postoperative care following endoscopic sinus surgery: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2011; 1(6): 417-30.
22. Sedaghat AR. Chronic rhinosinusitis. Am Fam Physician. Oct 15 2017; 96(8):500-506.
23. Smith TL, Singh A, Luong A, Ow RA, Shotts SD, Sautter NB, Han JK, Stamaugh J, Raman A. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016; 126:2659-2664.
24. Xu JJ, Busato GM, McKnight C, et al. Absorbable steroid-impregnated spacer after endoscopic sinus surgery to reduce synechiae formation. Ann Otol Rhinol Laryngol. Sep 21 2015.

POLICY HISTORY:

Medical Policy Panel, July 2012

Medical Policy Group, July 2012 (2) New policy

Medical Policy Administration Committee, July 2012

Available for comment July 26 through September 4, 2012

Medical Policy Panel, November 2013

Medical Policy Group, January 2014 (2): No change to policy statement.  “Spacer” removed from title and body of policy. Key Points, Approved by Governing Bodies, Key Words, References updated with results of literature search through September 2013. 

Medical Policy Panel, November 2014

Medical Policy Group, November 2014 (5): Updates to Description, Key Points and References. No Policy change.

Medical Policy Group, November 2015: 2016 Annual Coding Update. Added CPT codes 0406T and0407T to Current Coding; also added a Previous Coding section.

Medical Policy Panel, February 2016

Medical Policy Group, February 2016 (2): 2016 Updates to Title, Description, Key Points, and References; policy statement updated to include “and for treatment of recurrent sinonasal polyposis- no change in coverage- policy remains investigational.

Medical Policy Panel, February 2017

Medical Policy Group, March 2017 (6): Updates to Key Points. No change to policy statement.

Medical Policy Group, February 2018 (6): Updated Governing Bodies, Key Words and References to include Sinuva. No change to policy intent.

Medical Policy Group, February 2018 (6): Clarified policy title and statement to include “drug- eluting implants”. Updated policy with Sinu-Foam™ to Key Points, Coding and Governing Bodies. No change to policy intent.

Medical Policy Panel, February 2018

Medical Policy Group, March 2018 (6): Updates to Description, Key Points and References.

Medical Policy Group, May 2018 (6): Updates to Description, Governing Bodies, Coding and References to include Sinuva and LATERA; added “nasal” to policy statement, Latera already investigational per DORS.

Medical Policy Group, October 2018 (6): Information for Latera moved to MP #721 Absorbable Nasal Implant for Treatment of Nasal Valve Collapse.

Medical Policy Group, December 2018:  2019 Annual Coding Update. Moved CPT codes from Current coding section to previous coding.  Updated previous coding section to include codes 0406T and 0407T.

Medical Policy Panel February 2019

Medical Policy Group, March 2019 (6): Updates to Description, Key Points, Governing Bodies, Coding (added 31237/ 31299) and References.

Medical Policy Group, September 2019: October 2019 quarterly coding update.  Added new CPT code J7401 to Current Coding.  Moved deleted code S1090 to Previous Coding section.

Medical Policy Group, January 2020 (6): All information regarding SINUVA moved to new medical policy #708 SINUVA (mometasone furoate).

Medical Policy Panel, February 2020

Medical Policy Group, February 2020 (6): Updates to Key Points.

Medical Policy Panel, February 2021

Medical Policy Group, February 2021 (6): Updates to Key Points, Approved by Governing Bodies, and References.  No change to policy statement.

Medical Policy Group, March 2021: Quarterly Coding Update. Added new code S1091 to Current Coding.  Moved deleted code J7401 to Previous Coding.

Medical Policy Group, May 2021(5): Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, February 2022

Medical Policy Group, February 2022 (5): Updates to Key Points and References. No change to Policy Statement.

Medical Policy Panel, February 2023

Medical Policy Group, February 2023 (5): Updates to Key Points, Practice Guidelines and Position Statements, Benefit Application, and References. No change to Policy Statement.

Medical Policy Panel, February 2024

Medical Policy Group, March 2024 (9): Update to Key Points and References. Removed Previous Coding Section. No change to Policy Statement.

Medical Policy Group, June 2024 (6): All information regarding MP 708 Sinuva transferred to current policy. Policy title update to “Steroid-Eluting Sinus Stents and Implants”. On draft 7/1/24-8/15/24.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.