Latest Review Date: October 2024

Category: Medical

POLICY:

The insertion of an absorbable nasal implant for the treatment of symptomatic nasal valve collapse (NVC) is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Nasal valve collapse (NVC) is a readily identifiable cause of nasal obstruction. Specifically, the internal nasal valve represents the narrowest portion of the nasal airway with the upper lateral nasal cartilages present as supporting structures. The external nasal valve is an area of potential dynamic collapse that is supported by the lower lateral cartilages. Damaged or weakened cartilage will further decrease airway capacity and increase airflow resistance and may be associated with symptoms of obstruction. Individuals with NVC may be treated with nonsurgical interventions in an attempt to increase the airway capacity but severe symptoms and anatomic distortion are treated with surgical cartilage graft procedures. The placement of an absorbable implant to support the lateral nasal cartilages has been proposed as an alternative to more invasive grafting procedures in individuals with severe nasal obstruction. The concept is that the implant may provide support to the lateral nasal wall prior to resorption and then stiffen the wall with scarring as it is reabsorbed.

Nasal Obstruction

Nasal obstruction is defined clinically as an individual symptom that presents as a sensation of reduced or insufficient airflow through the nose. Commonly, individuals will feel that they have nasal congestion or stuffiness. In adults, clinicians focus the evaluation on important features of the history provided by the individual such as whether symptoms are unilateral or bilateral. Unilateral symptoms are more suggestive of structural causes of nasal obstruction. A history of trauma or previous nasal surgery, especially septoplasty or rhinoplasty, is also important. Diurnal or seasonal variations in symptoms are associated with allergic conditions.

Etiology

Nasal obstruction associated with the external nasal valve is commonly associated with post-rhinoplasty or traumatic sequelae and may require functional rhinoplasty procedures. A common cause of internal nasal valve collapse is septal deviation. Prior nasal surgery, nasal trauma and congenital anomaly are additional causes.

Pathophysiology

The internal nasal valve, bordered by the collapsible soft tissue between the upper and lower lateral cartilages, anterior end of the inferior turbinate and the nasal septum, forms the narrowest part of the nasal airway. During inspiration, the lateral wall cartilage is dynamic and draws inward toward the septum and the internal nasal valve narrows providing protection to the upper airways. The angle at the junction between the septum and upper lateral cartilage is normally 10 to 15 degrees in the White population. Given that the internal nasal valve accounts for at least half of the nasal airway resistance; even minor further narrowing of this area can lead to symptomatic obstruction for an individual. Damaged or weakened lateral nasal cartilage will further decrease airway capacity of the internal nasal valve area, increase airflow resistance and symptoms of congestion.

Physical Examination

A thorough physical examination of the nose, nasal cavity, and the nasopharynx is generally sufficient to identify the most likely etiology for the nasal obstruction. Both the external and internal nasal valve areas should be examined. The external nasal valve is at the level of the internal nostril. It is formed by the caudal portion of the lower lateral cartilage, surrounding soft tissue and the membranous septum.

The Cottle maneuver is an examination in which the cheek on the symptomatic side is gently pulled laterally with one to two fingers. If the individual is less symptomatic with inspiration during the maneuver, the assumption is that the nasal valve has been widened from a collapsed state or dynamic nasal valve collapse. An individual can perform the maneuver on oneself and it is subjective. A clinician performs the modified Cottle maneuver. A cotton swab or curette is inserted into the nasal cavity to support the nasal cartilage and the individual reports whether there is improvement in their symptoms with inspiration. In both instances, a change in the external contour of the lateral nose may be apparent to both the individual and the examiner.

Treatment

Treatment of symptomatic nasal valve collapse includes the use of non-surgical interventions such as the adhesive strips that are applied externally across the nose (applying the principle of the Cottle maneuver) or the use of nasal dilators, cones or other devices that support the lateral nasal wall internally (applying the principle of the modified Cottle maneuver).

Severe cases of obstruction resulting from nasal valve deformities are treated with surgical grafting to widen and/or strengthen the valve. Common materials include cartilaginous autografts and allografts, as well as permanent synthetic grafts. Cartilage grafts are most commonly harvested from the individual’s nasal septum or ear.

Nasal Implants

The placement of an absorbable implant to support the lateral nasal cartilages has been proposed as an alternative to more invasive grafting procedures in individuals with severe nasal obstruction.

U.S. Preventative Services Task Force Recommendations

Not applicable.

KEY POINTS:

The most recent literature update was performed through August 12, 2024.

Summary of Evidence

For individuals with symptomatic nasal obstruction due to internal nasal valve collapse (NVC) who receive an absorbable lateral nasal valve implant, the evidence includes one randomized controlled trial (RCT) with a 24-month uncontrolled follow-up phase, three non-randomized prospective and single cohort studies. Relevant outcomes are symptoms, change in disease status, treatment related morbidity, functional outcomes and quality of life (QOL). Overall, improvements in a nasal obstruction score have been demonstrated in study reports. Follow-up at 3 months in the RCT showed a statistically significant improvement in response with the implant compared to the sham group, although over half of the control group were also considered responders. Twenty-four month follow-up has been reported in the 3 multicenter cohort studies and the uncontrolled crossover phase of the RCT. Loss to follow-up was high, although sensitivity analysis with a worst-case scenario supported an improvement in symptoms at 24 months. As reported, adverse events appeared to be mild in severity and self-limiting, but still common. In the larger cohorts, device retrievals or extrusions occurred in 4% of patients. The need for device retrievals appears to occur early in the course of follow-up (1 month); suggesting technical experience limitations on the part of the operator or inappropriate patient selection. No studies have been identified that compared insertion of an implant with inferior turbinate reduction and/or septoplasty. 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 Foundation

In 2023, the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) issued a position statement on nasal valve repair stating that treatment options of nasal valve dysfunction may include implants aimed at stabilizing the nasal valve. No specific recommendations were made for nasal implants. The AAO-HNS recognizes surgical repair of the nasal valve as a distinct surgical procedure that can alleviate nasal obstruction symptoms for individuals who have nasal valve collapse and are suitable candidates for this intervention.

In 2010, AAO-HNS released a clinical consensus statement on the diagnosis and management of nasal valve compromise. No more recent guidelines were identified. Table 1 summarizes the key consensus statements relevant to this review. The statement also indicated that nasal endoscopy and nasal photography were both deemed useful but not routinely required.

Table 1. Consensus Agreement: Diagnosis and Treatment of Nasal Valve Compromise

KEY WORDS:

Latera®, absorbable nasal implant, nasal valve collapse

APPROVED BY GOVERNING BODIES:

In May 2016, LATERA® (Entellus Medical/Stryker ENT, previously Spirox) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process.  LATERA® is the only commercially available absorbable nasal implant for the treatment of nasal valve collapse. It is a class II device and regulatory details are summarized in Table 2.

Table 2. Absorbable Nasal Implant Cleared by FDA

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:

REFERENCES:

1. American Academy of Otolaryngology-Head and Neck Surgery. Position Statement: Nasal Valve Repair, 2023; www.entnet.org/resource/positon-statement-nasal-valve-repair.
2. Bikhazi N, Ow RA, O'Malley EM, et al. Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse. Facial Plast Surg. Dec 29 2021.
3. Fraser L, Kelly G. An evidence-based approach to the management of the adult with nasal obstruction. Clin Otolaryngol. Apr 2009; 34(2): 151-5. 
4. Howard BK, Rohrich RJ. Understanding the nasal airway: principles and practice. Plast Reconstr Surg. Mar 2002; 109(3): 1128-46; quiz 1145-6.
5. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
6. Lipan MJ, Most SP. Development of a severity classification system for subjective nasal obstruction. JAMA Facial Plast Surg. Sep-Oct 2013; 15(5): 358-61.
7. Olson MD, Barrera JE. A comparison of an absorbable nasal implant versus functional rhinoplasty for nasal obstruction. Am J Otolaryngol. Nov-Dec 2021; 42(6): 103118.
8. Rhee JS, Weaver EM, Park SS, et al. Clinical consensus statement: Diagnosis and management of nasal valve compromise. Otolaryngol Head Neck Surg. Jul 2010; 143(1): 48-59.
9. San Nicolo M, Stelter K, Sadick H, et al. A 2-Year Follow-up Study of an Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. Oct 2018; 34(5): 545-550.
10. San Nicolo M, Stelter K, Sadick H, et al. Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. Apr 2017; 33(2): 233-240.
11. Sidle DM, Stolovitzky P, O'Malley EM, et al. Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures. Facial Plast Surg. Oct 2021; 37(5): 673-680.
12. Sidle DM, Stolovitzky P, Ow RA, et al. Twelve-month outcomes of a bioabsorbable implant for in-office treatment of dynamic nasal valve collapse. Laryngoscope. May 2020; 130(5): 1132-1137.
13. Stewart MG, Witsell DL, Smith TL, et al. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. Feb 2004; 130(2): 157-63.
14. Stolovitzky P, Senior B, Ow RA, et al. Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial. Int Forum Allergy Rhinol. Aug 2019; 9(8): 850-856.
15. Stolovitzky P, Sidle DM, Ow RA, et al. A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant. Laryngoscope. Nov 2018; 128(11): 2483-2489.
16. Stryker. Latera. www.stryker.com/us/en/ent/products/latera-absorbable-nasal-implant-system.html

POLICY HISTORY:

Medical Policy Panel, October 2018

Medical Policy Group, October 2018 (6): New medical policy, information regarding LATERA transferred from MP#501 Implantable Sinus Stents and Drug-Eluting Implants for Postoperative Use Following Endoscopic Sinus Surgery and for Recurrent Sinus Disease. LATERA was previously non-covered per internal processing guidelines prior to MP #501.

Medical Policy Administration Committee, November 2018

Available for comment October 19, 2018 through December 3, 2018

Medical Policy Panel, October 2019

Medical Policy Group, October 2019 (6): Updates to Description, Key Points and References. No change to policy intent.

Medical Policy Panel, October 2020

Medical Policy Group, October 2020 (5): Updates to Key Points, Approved by Governing Bodies, and References. No change to Policy Statement.

Medical Policy Panel, October 2021

Medical Policy Group, October 2021 (5): Updates to Description, Key Points, Approved by Governing Bodies, and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Group, November 2020 (5): 2021 Annual Coding update. Added CPT 30468 to the Current Coding section.

Medical Policy Panel, October 2022

Medical Policy Group, October 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, October 2023

Medical Policy Group, October 2023 (9): Updates to Description, Key Points, Practice Guidelines and Position Statements, Benefit Application and References; no change to policy statement.

Medical Policy Panel, October 2024

Medical Policy Group, October 2024 (3): Updates to Key Points, Approved Governing Bodies, Coding removed 30999, and References. No change to the policy statement or intent.

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.