Latest Review Date: April 2024                    

Category: Surgery                                                                                          

POLICY:

Cryoablation for chronic rhinitis (allergic or nonallergic) is considered investigational.

Radiofrequency ablation for chronic rhinitis (allergic or nonallergic) is considered investigational.

Laser ablation for chronic rhinitis (allergic and non-allergic) is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Chronic rhinitis is a common medical condition that encompasses allergic rhinitis, nonallergic rhinitis, and mixed rhinitis and can severely impact quality of life. The initial treatment for chronic rhinitis often involves medical management with pharmacotherapy that may include steroids, anticholinergics, nasal decongestants, and antihistamines. For individuals who do not attain improvement in chronic rhinitis symptoms after receiving adequate medical therapy (referred to as refractory chronic rhinitis), invasive surgical options to block posterior nasal nerve may be considered. Historically, vidian neurectomy which targets the vidian nerve was offered for refractory rhinitis. Although vidian neurectomy was shown to be effective in reducing symptoms like rhinorrhea, it is associated with side effects of cheek and palate numbness and dry eyes (in nearly 50% of cases, ranging between 35 to 72%). In an effort to improve on complications of vidian neurectomy such as xerophthalmia, interventions that specifically target the posterior nasal nerve branches of the vidian nerve have been developed. These interventions range from surgical ablation of the post-ganglionic posterior nasal nerve to minimally invasive options of cryotherapy, radiofrequency, or laser ablation of the nerve. These minimally invasive procedures can be performed under endoscopy. The efficacy of ablation of posterior nasal nerve is thought to result from the interruption of efferent parasympathetic stimulation of the nasal mucosa, which leads to reduction in submucosal gland secretions and blood flow.

Chronic rhinitis is a common medical condition that encompasses allergic rhinitis, nonallergic rhinitis, and mixed rhinitis and can severely impact quality of life. The initial treatment for chronic rhinitis often involves medical management with pharmacotherapy that may include steroids, anticholinergics, nasal decongestants, and antihistamines. Although medications are the mainstay treatment option, approximately 10% to 22% of the patients with chronic rhinitis still have persistent symptoms despite medical therapy and may require further interventions. For individuals who do not attain improvement in chronic rhinitis symptoms after receiving adequate medical therapy (referred to as refractory chronic rhinitis), invasive surgical options to block posterior nasal nerve may be considered. Historically, vidian neurectomy which targets the vidian nerve was offered for refractory rhinitis. Although vidian neurectomy was shown to be effective in reducing symptoms like rhinorrhea, it is associated with side effects of cheek and palate numbness and dry eyes (in nearly 50% of cases, ranging between 35% to 72%). In an effort to improve on complications of vidian neurectomy such as xerophthalmia, interventions that specifically target the posterior nasal nerve branches of the vidian nerve have been developed. It is thought that such interventions would help to reduce the morbidity associated with vidian neurectomy. These interventions range from surgical ablation of the post-ganglionic posterior nasal nerve to minimally invasive options of cryotherapy, radiofrequency, or laser ablation of the nerve. These minimally invasive procedures can be performed under endoscopy. The efficacy of ablation of posterior nasal nerve is thought to result from the interruption of efferent parasympathetic stimulation of the nasal mucosa, which leads to reduction in submucosal gland secretions and blood flow.

To quantify the severity of chronic rhinitis and to assess treatment response, various outcome measures can be used, including radiologic scores, endoscopic grading, and patient-reported quality of life measures. The primary outcome measures relevant for the treatment of chronic rhinitis are patient-reported symptoms and quality of life. Examiner evaluation of the nasal and sinus appearance and polyp size may provide some information about treatment outcomes, but these evaluations are limited by the lack of universally accepted standards.

Frequently used outcome measures for treatments of chronic rhinitis in adults are shown in Table 1. A consensus on the minimally clinically important difference (MCID) for some of these outcomes has not been established. The U.S. Food and Drug Administration (FDA) guidance on drugs for rhinitis recommends patient-reported total nasal symptom scores as the primary measure of efficacy. The FDA guidance on drugs for rhinitis does not specify a MCID for patient-reported symptom measures, but notes that a MCID should be prespecified in studies and the rationale explained. Adverse events must be assessed immediately (perioperative complications and postoperative pain) and over the longer term.

Table 1. Outcome Measures for Chronic Rhinitis Interventions

KEY POINTS:

This evidence review was created in September 2019 with a search of the PubMed database. The most recent literature update was performed through December 18, 2023.

Summary of Evidence

For individuals with chronic rhinitis who receive cryoablation, the evidence includes a randomized controlled trial (RCT) and nonrandomized studies. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. One RCT that compared cryoablation using the ClariFix device with a sham procedure showed a statistically significant difference in response rate in favor of cryoablation group compared to the sham group. However, it is unclear if the trial enrolled individuals with chronic rhinitis who were refractory to medical management. This limitation precludes meaningful interpretation of these results as the intended use of ClariFix device is for individuals with chronic rhinitis who are refractory to medical management. This limitation precludes meaningful interpretation of these results as the intended use of ClariFix device is for individuals with chronic rhinitis who are refractory to medical management. Three single-arm prospective studies evaluated efficacy and safety of cryoablation for patients with chronic rhinitis. Out of the 3, 2 studies enrolled individuals who were refractory to medical management. The definition of refractory varied from symptoms not adequately controlled with a minimum of 4 weeks of topical nasal steroid treatment or failure of medical therapy fora duration of at least 3 months. Although all 3 single arm studies reported improvement in symptom control, the major limitation is lack of a comparator group and open-label nature of the study design, which likely introduces biases. Additionally, loss to follow-up was high. Randomized controlled trials with a clearly defined refractory patient population directly comparing cryoablation with sham surgery or other surgical interventions are needed to confirm the efficacy of cryoablation for treatment of chronic rhinitis. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with chronic rhinitis refractory to medical management who receive radiofrequency ablation, the evidence includes an RCT and nonrandomized studies. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. One RCT that compared radiofrequency using the RhinAer device with a sham procedure showed a statistically significant difference in response rate in favor of radiofrequency ablation group compared to the sham group. However, it is unclear if the trial enrolled individuals with chronic rhinitis who were refractory to medical management. This limitation precludes meaningful interpretation of these results as the intended use of RhinAer device is for individuals with chronic rhinitis who are refractory to medical management. Two single-arm prospective studies evaluated efficacy and safety of radiofrequency ablation for patients with chronic rhinitis. Out of the 2, 1 study enrolled individuals who were refractory to medical management. Although both single arm studies reported improvement in symptom control, the major limitation is lack of a comparator group and open-label nature of the study design, which likely introduces biases. Randomized controlled trials with a clearly defined refractory patient population directly comparing radiofrequency with sham surgery or other surgical interventions are needed to confirm the efficacy of radiofrequency ablation for treatment of chronic rhinitis. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with allergic or nonallergic chronic rhinitis who receive laser ablation, the evidence includes one nonrandomized study. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Although the single-arm prospective study reported improvement in symptom control, the major limitation is lack of a comparator group and open-label nature of the study design, which likely introduces biases. In addition, the authors did not define how study participants were classified as refractory to medical management. Randomized controlled trials with a clearly defined refractory patient population directly comparing laser ablation with sham surgery or other surgical interventions are needed to confirm the efficacy of radiofrequency ablation for treatment of chronic rhinitis. 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 Allergy, Asthma, and Immunology

The 2023 International Consensus Statement on Allergy and Rhinology stated the following for cryotherapy/radiofrequency ablation of posterior nasal nerve.

• Aggregate grade of evidence: C (Level 3: 2 studies, level 4: 4 studies, level 5: 5 studies)
• Benefit: Improvement in rhinorrhea.
• Harm: Risk of complications (e.g., epistaxis, temporary facial pain and swelling, headaches), limited long-term results.
• Cost: Surgical/procedural costs, cost of device, potential time off from work.
• Benefits-harm assessment: Potential benefit must be balanced with low risk of harm, especially considering limited long-term results.
• Value judgments: Patients may experience an improvement in symptoms.
• Policy level: Option.
• Intervention: Cryoablation and radiofrequency ablation of the posterior nasal nerve may be considered in allergic rhinitis patients that have failed medical management, particularly for rhinorrhea.

Grade of evidence "C" implies that body of evidence consisted of observational studies (case control and cohort design). Policy level "Option" implies "either that the evidence quality that exists is suspect or that well-designed, well conducted studies have demonstrated little clear advantage to one approach versus another. Options offer clinicians flexibility in their decision-making regarding appropriate practice, although they may set boundaries on alternatives. Patient preference should have a substantial role in influencing clinical decision-making, particularly when policies are expressed as options." As per the consensus statement, "because the current evidence is primarily based on industry-sponsored studies with limited long-term data, these office-based interventions remain an option for properly selected patients."

American Academy of Otolaryngology

In January 2023, the American Academy of Otolaryngology issued a position statement on peripheral nerve ablation for the treatment of chronic rhinitis. The position statement was not based on a systematic review or strength of evidence rating. According to the position statement, " Based on these safety and efficacy data, the American Academy of Otolaryngology endorses the use of posterior nasal nerve ablation for the treatment of medically-refractory chronic rhinitis. We do not consider these treatments to be experimental."

American Rhinologic Society

In January 2022, the American Rhinologic Society issued a position paper on posterior nasal nerve ablation. The position statement was not based on a systematic review or strength of evidence rating. According to the position statement, "The American Rhinologic Society supports the use of posterior nasal nerve ablation for the treatment of chronic rhinitis, including both allergic and non-allergic subtypes. This procedure should not be considered experimental, but should be considered as an effective option in treating chronic rhinitis and improving patient quality of life in those suffering from rhinorrhea and nasal congestion based on the following data."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Cryoablation, Cryosurgical ablation, cryosurgery, Chronic Rhinitis, ClariFix® (Arrinex), RhinAer® stylus, Radiofrequency ablation, Laser ablation

APPROVED BY GOVERNING BODIES:

In February 2019, the ClariFix™ device (Stryker) was cleared for use in adults with chronic rhinitis by the FDA through the 510(k) process (K190356). Clearance was based on substantial equivalence to the predicate device, ClariFix (K162608). The only modification to the subject device was an update to the indications for use to include adults with chronic rhinitis. As per the FDA 510K summary, the ClariFix device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.

In December 2019, the RhinAer™ stylus (Aerin Medical) was cleared by the FDA through the 510(k) process as a tool to treat chronic rhinitis (K192471). Clearance was based on equivalence in design and intended use of a predicate device, the InSeca ARC Stylus™ (K162810). The RhinAer stylus includes modification of the InSeca ARC stylus shaft components and flexibility. Asper the FDA 510K summary, the RhinAer is indicated for use in otorhinolaryngology surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.

There are currently no laser ablation devices with FDA clearance for treatment of chronic rhinitis.

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:

PREVIOUS CODING:

REFERENCES:

1. American Academy of Otolaryngology. Position Statement: PNN ablation for the treatment of chronic rhinitis. January2023.
2. American Rhinologic Society. Posterior Nasal Nerve Ablation ARS Position Statement. January 2022.
3. Chang MT, Song S, Hwang PH. Cryosurgical ablation for treatment of rhinitis: A prospective multicenter study. Laryngoscope. Aug 2020; 130(8): 1877-1884.
4. Del Signore AG, Greene JB, Russell JL, et al. Cryotherapy for treatment of chronic rhinitis: 3-month outcomes of a randomized, sham-controlled trial. Int Forum Allergy Rhinol. Jan 2022; 12(1): 51-61.
5. Del Signore AG, Greene JB, Russell JL, et al. Cryotherapy for treatment of chronic rhinitis: 3-month outcomes of a randomized, sham-controlled trial. Int Forum Allergy Rhinol. Jan 2022; 12(1): 51-61.
6. Dykewicz MS, Wallace DV, Amrol DJ, et al. Rhinitis 2020: A practice parameter update. J Allergy Clin Immunol. Oct 2020; 146(4): 721-767.
7. Ehmer D, McDuffie CM, McIntyre JB, et al. Long-term Outcomes Following Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Chronic Rhinitis. Allergy Rhinol (Providence). 2022; 13: 21526575221096045.
8. Ehmer D, McDuffie CM, Scurry WC, et al. Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Rhinitis. Am J Rhinol Allergy. Jan 2022; 36(1): 149-156.
9. Ehmer D, McDuffie CM, Scurry WC, et al. Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Rhinitis. Am J Rhinol Allergy. Jan 2022; 36(1): 149-156.
10. Food & Drug Administration. Clarifix 510(k) Premarket Notification. 2019 (K190356) fda.report/PMN/K190356/19/K190356.pdf.
11. Food & Drug Administration. RhinAer (RHIN1 Stylus) 510(k) Premarket Notification. 2019 (K192471).
12. Gerka Stuyt JA, Luk L, Keschner D, et al. Evaluation of In-Office Cryoablation of Posterior Nasal Nerves for the Treatment of Rhinitis. Allergy Rhinol (Providence). Jan-Dec 2021; 12: 2152656720988565.
13. Hwang PH, Lin B, Weiss R, et al. Cryosurgical posterior nasal tissue ablation for the treatment of rhinitis. Int Forum Allergy Rhinol. Oct 2017; 7(10): 952-956.
14. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
15. Kompelli AR, Janz TA, Rowan NR, et al. Cryotherapy for the Treatment of Chronic Rhinitis: A Qualitative Systematic Review. Am J Rhinol Allergy. Nov 2018; 32(6): 491-501.
16. Lee JT, Abbas GM, Charous DD, et al. Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis. Am J Rhinol Allergy. Nov 2022; 36(6): 747-754.
17. Lieberman P.L.. Chronic nonallergic rhinitis. In: UpToDate, Corren J (Ed), UpToDate, Waltham, MA. www.uptodate.com/contents/chronic-nonallergic-rhinitis.
18. Ow RA, O'Malley EM, Han JK, et al. Cryosurgical Ablation for Treatment of Rhinitis: Two-Year Results of a Prospective Multicenter Study. Laryngoscope. Sep 2021; 131(9): 1952-1957.
19. Takashima M, Stolovitzky JP, Ow RA, et al. Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial. Int Forum Allergy Rhinol. Jun 17 2022.
20. Takashima M, Stolovitzky JP, Ow RA, et al. Temperature-controlled radiofrequency neurolysis for treatment of chronicrhinitis: 12-month outcomes after treatment in a randomized controlled trial. Int Forum Allergy Rhinol. Feb 2023; 13(2): 107-115.
21. Wise SK, Damask C, Roland LT, et al. International consensus statement on allergy and rhinology: Allergic rhinitis - 2023.Int Forum Allergy Rhinol. Apr 2023; 13(4): 293-859.
22. Zubair A, Lasrado S. Vidian Neurectomy. [Updated 2023 May 14]. In: StatPearls [Internet]. Treasure Island (FL):StatPearls Publishing; 2024 Jan-. Available from: www.ncbi.nlm.nih.gov/books/NBK563142/]

POLICY HISTORY:

Medical Policy Panel, September 2021

Medical Policy Group, September 2021 (5): New medical policy. Available for comment September 29, 2021 through November 13, 2021.

Medical Policy Panel, February 2022

Medical Policy Group, February 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, Key Words, Approved by Governing Bodies, and References. Title changed from “Cryoablation for Chronic Rhinitis” to “Cryoablation, Radiofrequency Ablation and Laser Ablation for Treatment of Chronic Rhinitis.” Current Coding section updated to include HCPCS code C9771. Policy Statement updated to include Radiofrequency ablation and Laser ablation for chronic rhinitis (allergic and non allergic) as investigational. These procedures were previously investigational per MP#495: Investigational Criteria. Available for comment March 1, 2022 through April 15, 2022.

Medical Policy Panel, February 2023

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

Medical Policy Group, November 2023:  2024 Annual Coding Update.  Added CPT codes 31242 and 31243 to the Current Coding section. New codes effective 01/01/24.

Medical Policy Panel, March 2024

Medical Policy Group, April 2024 (9): Updates to Description, Key Points; Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. No change to Policy Statement.

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.