Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Implantable Steroid-Eluting Sinus Stents

Policy #:11.16.08b

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin 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 Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's benefit contract.

Although the US Food and Drug Administration (FDA) has approved devices for implantable steroid-eluting sinus stents, the Company has determined that the safety and/or effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature. Therefore, implantable steroid-eluting sinus stents are considered experimental/investigational by the Company and not covered.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, implantable steroid-eluting sinus stents are not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.
Description

PROPOSED CLINICAL APPLICATIONS OF IMPLANTABLE STEROID-ELUTING SINUS STENTS

Implantable sinus stents are typically explored as an option for postoperative management following sinus procedures such as endoscopic sinus surgery (ESS). Implantable sinus stents are intended to stabilize the sinus opening of the turbinates, and/or to serve as a local drug delivery vehicle thereby reducing inflammation and maintaining patency of the sinuses to achieve optimal sinus drainage.

The Propel system (Intersect ENT, Palo Alto, CA) was granted the US Food and Drug Administration (FDA) approval under the premarketing approval (PMA) program in August 2011. The labeled indications are for individuals, 18 years of age and older, following ethmoid sinus surgery to maintain patency, thereby reducing the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids. In August 2012, the FDA approved Intersect ENT's PMA supplement for the Propel Mini, and in March, 2016 the FDA approved an expanded frontal sinus indication for PROPEL mini. The Propel Mini is a smaller version of the device that may be used in individuals with less extensive surgery or smaller anatomy. The manufacturer reports that the smaller version offers the same clinical benefits as the original Propel. The device is a self-expanding, bioabsorbable, steroid eluting stent that is intended for use in the ethmoid or frontal sinus. It is placed via endoscope guidance using a plunger that is included with the device. Mometasone furoate is embedded in a polyethylene glycol polymer, which allows sustained release of the drug over an approximate duration of 30 days. The device is completely biodegradable over a period of several weeks, and therefore does not require removal. Propel and Propel mini are the first and only FDA-approved drug eluting sinus implants designed for placement in the specified sinuses, of an adult who has undergone ESS.

The Pilot study, Murr et al (2011), was a randomized, double blind, intra-patient control trial sponsored by Intersect ENT Palo Alto, CA. The study included 43 individuals with refractory chronic rhinosinusitis receiving Propel; 38 of these were intra-patient control design comparing implantable mometasone furoate eluting sinus stents to identical non-drug eluting implantable sinus stents. The other five individuals received bilateral mometasone furoate eluting Propel implants to assess systemic safety. The implants were deployed in 86 sinuses. Endpoints of ethmoid sinus inflammation, polypoid change, middle turbinate position, adhesions/synechiae and adverse events were assessed by direct endoscopic examination on days 7, 14, 21, 30, 45, and 60. Lower inflammation scores persisted to day 60, although the difference did not achieve statistical significance (p=0.0885). This was perhaps due to the study design where the re-initiation of steroid prescriptions began at 30-day follow-up, which likely blunted recorded differences between groups. Implant scaffolding function was present in both the treatment and control sides so that the study tests the value of the drug delivery via a stent, but does not test the value of a stent itself versus treatment without a stent. To ensure blinding of both physician and patient to the sinus treatment assignment, noncommercially available nonsteroidal-eluting sinus stents were used in control sinuses, such that the results from the study may not be generalizable to other FDA-approved nasal spacers. The study reported the number of individuals prescribed steroids but did not address whether disease in the Propel treated and/or control sinus cavity required postoperative interventions in addition to Propel or nonsteroid-eluting stent. According to the study authors, there is no widely accepted method to assess the efficacy of this new therapy in the ethmoid sinus, so they developed a new grading form which was not a validated measurement tool for evaluating ethmoid sinus inflammation, polypoid change, middle turbinate position, adhesions/synechiae formation, and the need of postoperative intervention. The clinicians recording the outcomes were the same physicians who were treating the patients, which may introduce bias. An additional limitation of this study was its small sample size (n = 43).

The Advance study, Forwith et al (2011), was a non-randomized, open label, multicenter, single-arm trial that studied the placement of a mometasone furoate eluting absorbable sinus sent in 50 individuals who were scheduled to undergo ESS. The study allowed bilateral or unilateral steroid-eluting sinus implant placement at the end of the ESS procedure. The endpoints included the degree of inflammation and semi-quantitative grading for polypoid changes, middle turbinate position, and adhesions. Oral or intranasal steroids were withheld during the first 60 days postoperatively to avoid overlapping routes of steroid administration, although clinicians were given the option to prescribe steroids if they deemed medically necessary. Individual reported outcomes were collected to six months. Individuals who received the stents had significant improvement in symptoms six months after surgery. Study included specific evaluation of ocular safety, the incorporation of individual symptom scores, and the withholding of systemic steroids for an expanded period of time. Although topical ophthalmic corticosteroids may lead to increased intraocular pressure (IOP) and ocular hypertension, the overall risk of IOP elevation and glaucoma reportedly does not seem to be increased with intranasal corticosteroids at regularly prescribed doses. The authors concluded that the stent appears to optimize surgical results by minimizing the occurrence of inflammation, adhesions, and polypoid tissue formation with negligible potential for ocular adverse effects. No evidence from this case series is available to determine whether mometasone furoate eluting absorbable sinus sent maintains sinus patency long-term. Additional limitations of this study were its small sample size (n = 50), and lack of randomization.

Advance II pivotal trial, Marple et al (2012), was a prospective, randomized, double blind, multi-center, intra-patient control trial sponsored by Intersect ENT Palo Alto, CA, that assessed the safety and efficacy of bioabsorbable steroid-releasing sinus implants. Implants were deployed in 210 ethmoid sinuses of 105 individuals with chronic rhinosinusitis refractory to medical management. Each individual received a drug-eluting stent on one side and a non-drug-eluting stent on the other via random assignment. No additional steroids were administered 30 days after procedure. Primary safety endpoint of the absence of clinically significant increased ocular pressure through day 90 following the procedure was met. The rate of post-operative intervention was 46.9 percent on the control implant sides compared to 33.3 percent on the treatment implant sides (p=0.0280, statistically significant). The drug-releasing implant provided a 29.0% relative reduction in postoperative interventions (p=0.028) and a 52 percent (p=0.005) decrease in lysis of adhesions. The relative reduction in frank polyposis was 44.9 percent (p=0.002). However, an independent panel, which assessed polyposis based on endoscopic video, found the decreased rate of polyposis in Propel treated sinuses, yet treating clinicians found no difference in the rate of polyposis in sinuses treated with Propel versus sinuses treated with the control stent. The reported ratings were significantly different between the two groups regarding the need for postoperative intervention and the presence of frank polyposis. The authors did not explain the reason for these differences.

Han et al (2012), performed an efficacy meta-analysis of the two published randomized control trials of the Propel implant, both of which compared a steroid-eluting stent with a non-steroid eluting stent. Postoperative day-30 videos were obtained for each patient, randomly ordered, and presented to an independent panel of three otolaryngologists for grading of efficacy endpoints. Combined results of implants placed in 286 ethmoid sinuses revealed that the mometasone furoate implant provided a 35 percent (p<0.001) reduction in postoperative interventions, reduced lysis of adhesions by 51 percent (p<0.001), and reduced oral steroid need by 40 percent (p<0.001) compared to controls. The relative reduction in frank polyposis was 46 percent (p<0.001).

Han et al (2014), reported results of the RESOLVE trial, a sham controlled RCT evaluating the use of office based placement of a mometasone-eluting nasal stent for individuals with recurrence of nasal polyposis after ESS. Eligible participants had chronic rhinosinusitis, had undergone prior bilateral total ethmoidectomy more than three months earlier, had endoscopically confirmed recurrent bilateral ethmoid sinus obstruction due to polyposis that was refractory to medical therapy, and were considered candidates for repeat surgery. The study authors concluded that the symptomatic improvement and statistically significant reduction in polyp grade and ethmoid sinus obstruction supported the efficacy of the steroid-eluting implant for in office treatment of chronic rhinosinusitis individuals with recurrent polyposis after ESS. Limitations included short duration of follow up, no defined medical treatment prior to study enrollment, and the clinicians were not blinded to the treatment assignment.

In a prospective single-arm case series, Matheny et al (2014), reported on the safety, feasibility, and efficacy of placement of steroid-elutng bioabsorbable sinus implants in the office setting. Steroid-eluting implant was deployed seven days after endoscopic sinus surgery including bilateral ethmoidectomy in a separate office based procedure. At one month there were no significant adhesions or frank polyposis, and middle turbinate lateralization was only five percent. Compared to baseline, ethmoid sinus inflammation was significantly reduced (p=0.03) and the mean Sino-Nasal Outcome Test (SNOT-20) score was significantly improved (p<0.001).

In a prospective, multi-center study, Lavigne et al (2014), reported results from a case series that enrolled 12 individuals with recurrent nasal polyposis, refractory to medical therapy, and studied the feasibility, safety, and effectiveness of steroid-eluting implants placed in the office setting in individuals who were candidates for revision ESS. Implants were placed bilaterally under topical anesthesia in an office setting. Follow-up through six months included endoscopic grading, patient reported outcomes (Sino-Nasal Outcome Test (SNOT-22), and need for revision ESS. Implants were successfully inserted in 21 of 24 (88%) ethmoid sinuses. No serious adverse events occurred. At the one month follow-up, mean bilateral polyp grade was reduced from 4.5 to 2.3 (p=0.008) and sustained through six months (2.33; p=0.008). Mean SNOT-22 score was significantly improved from 2.19 to 0.90 within one month (p=0.001) and sustained to six months (1.03; p = 0.012); 64 % of patients were no longer considered for revision ESS candidates at six months. The authors concluded that these findings provided initial clinical evidence of the feasibility, safety, and effectiveness of in-office steroid-eluting implant placement in individuals with recurrent nasal polyposis after ESS, refractory to medical therapy. Moreover, the authors concluded that although further studies are needed, the results suggest steroid-eluting implants may provide a safe and effective, office based option for the treatment of polyposis. The limitations of this study include its small sample size (n=12), lack of randomization, and lack of a concurrent control group. Well designed studies are needed to address these limitations and provide further clinical evidence of the safety and efficacy of sinus implants for individuals with chronic rhinosinusitis with recurrent polyposis as an in-office treatment.

In a prospective, single-center study, Ow et al (2014), reported on the treatment of five adult patients with recurrent nasal polyposis after bilateral total ethmoidectomy. Each patient successfully received two Propel steroid-releasing implants (10 ethmoid sinuses) in-office under local/topical anesthesia. Plasma mometasone and cortisol concentrations were determined before placement and through 30-day follow-up, which also included endoscopic grading along with patient-reported outcomes. There were no serious adverse events. The plasma concentrations of mometasone furoate were in the undetectable range, generally below the lower limit (30 pg/mL). Cortisol concentrations at follow-up ranged from 3.9 to 5.7 mg/dL compared to 4.7 mg/dL at baseline. At one month, there was a significant improvement in bilateral polyp grade (p=0.037), nasal obstruction score (p=0.002), and SNOT-22 (p=0.010) compared to baseline. The authors stated that these study results suggest that the implant provides a valid and safe option for the in-office treatment of recurrent nasal polyposis. Furthermore, the authors stated that randomized, controlled, blinded clinical studies are underway to provide additional evidence of safety and efficacy.

SUMMARY

The applicable FDA approvals for the commercially available stents generally state that the technology is intended to be used following ethmoid sinus surgery to maintain patency, thereby reducing the need for post-operative intervention, such as surgical adhesion lysis and/or use of oral steroids. The majority of the published literature, albeit limited in regard to methodological quality, has evaluated the safety and efficacy of the technology when implanted immediately following surgery. The literature consists of a few, small randomized trials, single-arm case series, and systematic reviews of these studies. Identified studies reported on outcomes of interest from a limited number of Individuals compared with the number of individuals with chronic rhinosinusitis who undergo sinus surgery annually. The two small randomized control trials (RCTs) both compare an implant that is steroid-eluting versus an implant that is not steroid-eluting. Thus these trials test the value of drug delivery via a stent, but do not assess the value of the stent itself versus treatment without a stent. No studies were found to compare implantable steroid-eluting sinus stents to management without the use of devices. The two RCTs also used unvalidated measures for the reported outcomes and may have been underpowered to find clinically and statistically significant differences between groups for the secondary endpoints. No evidence is available to determine whether implantable steroid-eluting sinus stents maintain sinus patency long-term, improve quality of life, reduce the need for steroids, or obviate the need for subsequent sinus surgery compared with other non-surgical methods of postoperative management (saline irritations, sinus cavity debridement, systemic steroids, topical steroids, oral antibiotics, topical decongestants). The study results are not adequate evidence to conclude that the use of the implantable steroid-eluting sinus stents are superior to standard postoperative care, because the control group did not receive standard postoperative care. Moreover, the lack of steroids of any type in the control group may represent under treatment compared with usual care. The evidence is insufficient to determine whether sinus stents improve outcomes when in conjunction with or following sinus surgery and other sinus procedures. Additional RCTs are needed that compare the device with optimal care without the device to determine whether they can improve outcomes for individuals undergoing sinus surgery or other sinus procedures.

More recently, the application of the technology within the office setting has also been evaluated. The evidence for implantable steroid-eluting sinus stents in individuals who have recurrent nasal polyposis includes a relatively small body of literature. Well designed studies are needed to address the limitations such as small sample size, lack of randomization, and lack of concurrent control group. Studies are needed to provide further clinical evidence of the safety and efficacy of steroid-eluting sinus implants for individuals with chronic rhinosinusitis with recurrent polyposis as an in-office treatment.

The overall body of literature, irrespective of setting (i.e., operative or office) is limited by small sample size(s), lack of applicable control groups, and limited follow-up periods, and preclude the establishment of generalizable conclusions. No data evaluating the safety, efficacy, and effectiveness of the technology in other non-FDA labeled indications have been published.
References

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. 2009;266(6):839-845.


Catalona PJ TM, Weiss R, Rimash T. The MicroFlow Spacer: A drug-eluting stent for the ethmoid sinus. Indian J Otolaryngol Head Neck Surg. 2011;63(3):258.

Cote DW, Wright ED. Triamcinolone-impregnated nasal dressing following endoscopic sinus surgery: a randomized, double-blind, placebo-controlled study. Laryngoscope. 2010;120(6):1269-1273.

Forwith KD, Chandra RK, Yun PT, et al. ADVANCE: a multisite trial of bioabsorbable steroid-eluting sinus implants. Laryngoscope. 2011;121(11):2473-2480.

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.2008;33(5):462-465.

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.

Han JK, Marple BF, Smith TL, et al. Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis. Int Forum Allergy Rhinol. 2012;2(4):271-279.

Lavigne F, Miller SK, Gould AR, et al. Steroid-eluting sinus implant for in-office treatment of recurrent nasal polyposis: a prospective, multicenter study. Int Forum Allergy Rhinol. 2014;4(5):381-389.

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. May 30 2012.

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):1004-1011.

Matheny KE, Carter KB, Jr., Tseng EY, et al. Safety, feasibility, and efficacy of placement of steroid-eluting bioabsorbable sinus implants in the office setting: a prospective case series. Int Forum Allergy Rhinol.2014;4(10):808-815.

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.

Ow R, Groppo E, Clutter D, et al. Steroid-eluting sinus implant for in-office treatment of recurrent polyposis: a pharmacokinetic study. Int Forum Allergy Rhinol. Sep 25 2014.

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. 2011;121(12):2702-2705.

Rudmik L MJ, Mechor B. Effect of a dexamethasone SinuFoam middle meatal spacer on endoscopic sinus surgery outcomes: A randomized, double-blind, placebo-controlled trial. Int Forum Allergy Rhinol. December. Epub ahead of print.

Steroid-eluting implant (Propel) for maintaining sinus patency after ethmoid sinus surgery. Plymouth Meeting (PA): ECRI Institute; 2015 February. (Emerging technology report). Also available: http://www.ecri.org.

Stewart AE, Vaughan WC. Balloon sinuplasty versus surgical management of chronic rhinosinusitis.Curr Allergy Asthma Rep. 2010;10(3):181–187.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Premarket Approval (PMA) Supplement. Decision Date 10/08/2014. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=353825 Accessed January 19, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). PROPEL®. 510(k) summary. [FDA Web site]. 08/11/2011. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100044b.pdf Accessed January 19, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH).PROPEL® Mini Sinus Implant. 510(k) summary. [FDA Web site]. 03/23/2016. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100044S018b.pdf. Accessed January 19, 2018.




Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

THE FOLLOWING CODE IS USED TO REPRESENT NASAL ENDOSCOPY, FRONTAL SINUS WITH PLACEMENT OF STEROID-ELUTING IMPLANT:

31299


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

This service is experimental/investigational for all diagnoses


HCPCS Level II Code Number(s)

S1090 Mometasone furoate sinus implant, 370 micrograms


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 11.16.08b:
01/01/2019 This version of the policy will become effective 01/01/2019.

The following CPTcodes have been termed from this policy:
0406T, 0407T
Revisions from 11.16.08a:
02/15/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on implantable steroid-eluting sinus stents
Effective 10/05/2017 this policy has been updated to the new policy template format.
Version Effective Date: 01/01/2019
Version Issued Date: 01/03/2019
Version Reissued Date: N/A

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