mp-501 - Medical Policies - Florida
Implantable Sinus Stents and Drug-Eluting Implants for Postoperative Use Following Endoscopic Sinus Surgery and for Recurrent Sinus Disease
Policy Number: MP-501
Latest Review Date: February 2020
Policy Grade: A
The use of implantable nasal/sinus stents or drug-eluting implants/stents are considered not medically necessary and 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 is an inflammatory sinus condition that has prevalence between 1% and 5% in the U.S. population.
Endoscopic sinus surgery (ESS) is typically performed in patients 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. 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 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.
Implantable Sinus Stents
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.
Sinus stents are defined as implantable devices that are 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 that are routinely employed post sinus surgery.
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.
The most recent literature search was performed through December 09, 2019. The following is a summary of the key findings to date.
SUMMARY OF EVIDENCE:
For individuals who have chronic rhinosinusitis who have undergone ESS who receive implantable steroid-eluting sinus stents, the evidence includes 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 most accurately evaluate the benefit 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 the effects of the technology on health outcomes.
For individuals who have recurrent sinonasal polyposis who have undergone endoscopic sinus surgery who receive implantable steroid-eluting sinus stents, 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 stents for recurrent or persistent nasal polyposis after ESS, which demonstrated improvements in polyp grade and ethmoid obstruction. Strengths of these trials included use of a 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. Sinus stents may prove to have a role in nasal polyposis; however, further follow-up is needed to evaluate the durability of the results. The evidence is insufficient to determine the effects of the technology on health outcomes.
PRACTICE GUIDELINES AND POSITION STATEMENTS:
No guidelines or statements were identified.
U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS:
Implantable sinus stents, implantable sinus spacers, PROPEL™, Relieva Stratus™ MicroFlow spacer, Mometasone furoate sinus implant, Sinu-Foam spacer,
APPROVED BY GOVERNING BODIES:
Intraoperative Steroid-Eluting Sinus Stents
In 2011, the PROPEL(R) 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(R) device, the PROPEL(R) mini Sinus Implant, was approved for use in patients older than age 18 years following ethmoid sinus surgery. In 2017, the PROPEL Contour was approved through a PMA supplement. The PROPEL(R) Contour Sinus Implant is an adaptable implant that is designed to maximize drug delivery to the frontal and maxillary sinus.
Sinu-Foam™ is a Food and Drug Administration (FDA)-approved mixture, which is commonly mixed with saline and gently placed in the ethmoid cavity following FESS. A dexamethasone Sinu-Foam spacer has been studied to examine if it could promote wound healing of the nasal and sinus mucosa by reducing the inflammation associated with CRS. However, its clinical utility remains a debate since it does not improve endoscopic outcomes in the early post-operative period following FESS.
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. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
|30999||Unlisted procedure, Nose|
|31237||Nasal/sinus endoscopy, surgical; with biopsy, polypectomy or debridement (separate procedure)|
|31299||Unlisted procedure, accessory sinuses|
|J7401||Mometasone furoate sinus implant, 10 microgram (Effective 10/1/19)|
|0406T||Nasal endoscopy, surgical, ethmoid sinus, placement of drug eluting implant; (Deleted 12/31/18)|
|0407T||; with biopsy, polypectomy or debridement (Deleted 12/31/18)|
|S1090||Mometasone furoate sinus implant, 370 micrograms (Deleted 9/30/19)|
- 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):839-45.
- 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):1269-73.
- Forwith KD, Chandra RK, Yun PT et al. ADVANCE: a multisite trial of bioabsorbable steroid-eluting sinus implants. Laryngoscope 2011; 121(11):2473-80.
- 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.
- Food & Drug Administration, Office of Criminal Investigations. July 22, 2016: Medical Device Manufacturer Acclarent Inc. to Pay $18 Million to Settle False Claims Act Allegations. 2016; https://www.fda.gov/iceci/criminalinvestigations/ucm512838.htm. Accessed January 18, 2018.
- 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):462-5.
- Han J, Forwith K, Brown W, et al. A Randomized, Controlled, Blinded, Multi-Center Study with Bioabsorbable Steroid-Eluting Sinus Implant for In-Office Treatment of Recurrent Sinonasal Polyposis: 3-Month Safety and Efficacy American Rhinologic Society (ARS at AAO) -- 60th Annual Meeting; September 20, 2014. 2014; Orlando, Florida.
- 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. 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.
- 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.
- 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).
- 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. May 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 2012; 2(6): 477-486.
- 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.
- 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.
- 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. Sep 15 2014.
- 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.
- 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. 2012; 2(3):248-251.
- 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):2702-5.
- Rudmik L, Mace J, Mechor B. Effect of a dexamethasone Sinu-FoamTM 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.
- 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. 2012 May-Jun; 2(3):248-51.
- 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.
- Sedaghat AR. Chronic rhinosinusitis. Am Fam Physician. Oct 15 2017; 96(8):500-506.
- 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.
- 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.
- Xu JJ, Busato GM, McKnight C, et al. Absorbable steroid-impregnated spacer after endoscopic sinus surgery to reduce synechiae formation. Ann Otol Rhinol Laryngol. Mar 2016;125(3):195-198.
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.
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.