Description
Ablation therapy is proposed as an alternative to medical management for patients with chronic rhinitis symptoms. Ablation therapy includes cryoablation (also known as cryosurgical ablation, cryosurgery, or cryotherapy), radiofrequency ablation, and laser ablation. Ablation therapy is thought to correct the imbalance of autonomic input to the nasal mucosa thereby reducing nasal antigen responses and vascular hyperreactivity.

Background 
Ablation therapy is proposed as an alternative to medical management for patients with chronic rhinitis symptoms. Ablation therapy includes cryoablation (also known as cryosurgical ablation, cryosurgery, or cryotherapy), radiofrequency ablation, and laser ablation. Ablation therapy is thought to correct the imbalance of autonomic input to the nasal mucosa thereby reducing nasal antigen responses and vascular hyperreactivity.

Medical management is the standard of care for chronic rhinitis. Surgical options such as vidian nerve resection have been investigated for patients with chronic rhinitis refractory to multiple medical therapies, and cryoablation is proposed as a less invasive alternative. Vidian neurectomy has not been widely adopted however, due to the need for general anesthesia, risk of serious adverse events (e.g., dry eyes in up to 25% of patients), and uncertainty about the procedure's long-term benefits.¹ 

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 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. 

Six months of follow-up is considered necessary to demonstrate efficacy. Adverse events can be assessed immediately (perioperative complications and postoperative pain) or over the longer term.

Table 1. Outcome Measures for Chronic Rhinitis Interventions

Regulatory Status
In February 2019, the Clarifix™ device (Stryker) was cleared for use in adults with chronic rhinitis through the 510(k) process (K190356).² 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.

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).³ 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.

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

Policy
Cryoablation for chronic rhinitis (allergic or non-allergic) is investigational/unproven therefore is considered NOT MEDICALLY NECESSARY.

Radiofrequency ablation for chronic rhinitis (allergic or non-allergic) is investigational/unproven therefore is considered NOT MEDICALLY NECESSARY.

Laser ablation for chronic rhinitis (allergic and non-allergic) is investigational/unproven therefore is considered NOT MEDICALLY NECESSARY. 

NOTE: CPT 30117 may be considered medically necessary for diagnoses other than chronic rhinitis (allergic or non-allergic). This policy should NOT be used to address diagnoses other than chronic rhinitis.

Policy Guidelines
See the Codes table for details. 

Benefit Application
BlueCard^®/National Account Issues 
State or federal mandates (e.g., Federal Employee Program) may dictate that certain U.S. Food and Drug Administration-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity. 

Rationale 
Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., people of color [African American, Asian, Black, Latino and Native American]; LGBTQIA [lesbian, gay, bisexual, transgender, queer, intersex, asexual]; women; and people with disabilities [physical and invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Cryoablation for Chronic Rhinitis
Clinical Context and Therapy Purpose
Cryoablation is proposed as an alternative to medical management for patients with chronic rhinitis.

The following PICO was used to select literature to inform this review.

Population
The relevant population of interest is adults ages 18 and older with chronic allergic or nonallergic rhinitis.

Rhinitis is defined as symptomatic inflammation of the paranasal sinuses and nasal cavity. Chronic rhinitis is usually defined as rhinorrhea with or without nasal congestion symptoms despite medical therapy lasting longer than 3 months. Allergic rhinitis is defined as an immunoglobulin E (IgE)-mediated inflammatory response of the nasal mucous membranes after exposure to inhaled allergens. Symptoms include rhinorrhea (anterior or post nasal drip), nasal congestion, nasal itching, and sneezing. Allergic rhinitis can be seasonal or perennial, with symptoms being intermittent or persistent.

Interventions
The therapy being considered is cryoablation. Cryoablation for chronic rhinitis involves destruction of tissue in the posterior nasal nerve region. The procedure is thought to correct the imbalance of autonomic input to the nasal mucosa, reducing nasal antigen responses and vascular hyperreactivity.

The ClariFix system uses nitrous oxide to freeze nasal tissue, causing nerve damage. The procedure can be performed under local anesthesia.

Comparators
The comparator of interest is medical management.

Options for the medical management of chronic rhinitis include allergen avoidance, nasal saline irrigation, and pharmacologic therapy (e.g., intranasal glucocorticoids, topical antihistamines, oral antihistamines, ipratropium).

For allergic rhinitis, treatment options include evaluation with appropriate allergy testing and the offering of immunotherapy.

Outcomes
The general outcomes of interest are symptoms, change in disease status, quality of life, and treatment-related morbidity.

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 above in Table 1 (see Background). Six months of follow-up is considered necessary to demonstrate efficacy. Adverse events can be assessed immediately (perioperative complications and postoperative pain) or over the longer term.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
Kompelli et al. (2018) conducted a systematic review of cryoablation for chronic rhinitis, identifying 15 nonrandomized studies enrolling a total of 1266 patients (Table 2).³ Across all of the studies, 63% to 95.7% of patients noted improvement in overall symptoms, and no serious adverse events were reported. The authors concluded that although the procedure appeared to be safe and efficacious, methodological weaknesses and heterogeneity limited the strength of conclusions that could be drawn from this body of evidence. In addition to their uncontrolled design, most studies were outdated, published between 1977 and 1997. Only 1 study, reported by Hwang et al. (2017) used a Food and Drug Administration (FDA)-cleared device and a validated outcome measure.⁴ This study is discussed in detail, along with other recent nonrandomized studies, in the following section.

Table 2. Systematic Review of Cryoablation for Chronic Rhinitis

Randomized Controlled Trials
One RCT conducted by Del Signore et al. (2021)5, compared cryoablation using the ClariFix device with a sham procedure in 133 adults (age ≥ 21 years) with chronic rhinitis (Tables 3 and 4). Outcomes assessed included the reflective Total Nasal Symptom Score (rTNSS) and the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score. Duration of follow-up was 3 months. Individuals randomized to active cryoablation were more likely than those in the sham group to respond to treatment (73.4% vs. 36.5%, p < .001), based on a rTNSS reduction of > 30%. Active cryoablation was also associated with greater reductions in RQLQ score from baseline at 3-month follow-up (-1.5; 95% confidence interval [CI], -1.8 to -1.2) versus sham cryoablation (-0.8; 95% CI, -1.1 to -0.5; p < .001). There was no difference between groups in use of allergy or rhinitis medication at 3 months. Study limitations are described in Tables 5 and 6.

Table 3. RCT of Cryoablation for Chronic Rhinitis — Characteristics

rTNSS: reflective Total Nasal Symptom Score.

Table 4. RCT of Cryoablation for Chronic Rhinitis — Results

The purpose of the study limitations tables (see Tables 5 and 6) is to display notable limitations identified in each study. This information is synthesized as a summary of the body of evidence following each table and provides the conclusions on the sufficiency of evidence supporting the position statement. Specifically, regarding the intended use population, study authors stated that cryoablation appeared to be effective in "patients who have been refractory to other medical and surgical therapies" but this population was not clearly defined at enrollment, nor was there any subgroup analysis undertaken limited to treatment-refractory patients. Based on the current RCT evidence, it is unclear if cryotherapy is intended to be adjunctive to or a replacement for medical management.

Table 5. Study Relevance Limitations

Table 6. Study Design and Conduct Limitations

Nonrandomized Studies
Three recent, single-arm, nonrandomized studies including 149 patients, reported in 4 publications, have evaluated cryoablation for patients with chronic rhinitis. Characteristics and results of these studies are shown in Tables 7 and 8. The largest study (N = 98) was reported by Chang et al. (2020),⁶ with 2-year follow-up data on a subset of patients (n = 62) reported by Ow et al. (2021).⁷ Scores on the rTNSS improved significantly over baseline at 1 month, 3 months, 6 months, and 9 months, and improvements were sustained for up to 2 years among those patients who enrolled in the follow-up study. Smaller single-arm studies reported by Hwang et al. (2017)⁴ and Gerka Stuyt et al. (2021)⁸ also reported improvements in symptoms from baseline (Table 8). Chang et al. (2020) reported 2 serious procedure-related adverse events: severe epistaxis occurring on posttreatment day 19 due to a pledget inadvertently left in the nasal cavity from the day of treatment, and 1 case of mild epistaxis occurring on posttreatment day 36, which resolved with in-office cautery. Of 72 patients completing a telephone questionnaire about procedure-related discomfort, 56 (77.8%) experienced some degree of pain or discomfort. Seventeen patents reported severe headache, 5 reported severe nasal pain, and 2 reported severe sinus pain.⁶ No serious adverse events were reported in the other studies (Table 8).

Key limitations of these studies are summarized in Tables 9 and 10. A major limitation was their uncontrolled, open-label design. Additionally, loss to follow-up was high and minimally clinically important differences (MCID) were not prespecified for important outcome measures. Randomized controlled trials are needed to confirm improvements in symptom scores observed in nonrandomized studies.

Table 7. Nonrandomized Studies of Cryoablation for Chronic Rhinitis — Characteristics

Table 8. Nonrandomized Studies of Cryoablation for Chronic Rhinitis - Results

Table 9. Study Relevance Limitations

Table 10. Study Design and Conduct Limitations

Section Summary: Cryoablation
For individuals with chronic rhinitis who receive cryoablation, the evidence includes a RCT, nonrandomized studies, and a systematic review of nonrandomized trials. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Three single-arm, open-label studies enrolling a total of 149 patients reported improvements from baseline in patient-reported symptom scores up to 1 year. Sustained improvement for up to 2 years was observed in 1 study; however, only 62 of 98 patients enrolled in the longer-term follow-up phase. In the largest study, there were 2 serious procedure-related adverse events (2.0%), and 77.8% of patients who responded to a post-procedure questionnaire reported some degree of pain or discomfort. Study limitations, including lack of a control group and high loss to follow-up, preclude drawing conclusions from this body of evidence. The RCT had an unclear intended use population, used a sham control group, and follow-up was limited to 3 months. A systematic review of 15 nonrandomized studies reported improvements with cryoablation; however, only 1 study used an approved device and validated outcome measuring.

Radiofrequency Ablation for Chronic Rhinitis
Clinical Context and Therapy Purpose
Radiofrequency ablation is proposed as an alternative to medical management for patients with chronic rhinitis.

The following PICO was used to select literature to inform this review.

Population
The relevant population of interest is individual with chronic allergic or nonallergic rhinitis.

Rhinitis is defined as symptomatic inflammation of the paranasal sinuses and nasal cavity. Chronic rhinitis is usually defined as rhinorrhea with or without nasal congestion symptoms despite medical therapy lasting longer than 3 months. Allergic rhinitis is defined as an IgE-mediated inflammatory response of the nasal mucous membranes after exposure to inhaled allergens. Symptoms include rhinorrhea (anterior or post nasal drip), nasal congestion, nasal itching, and sneezing. Allergic rhinitis can be seasonal or perennial, with symptoms being intermittent or persistent.

Interventions
The therapy being considered is radiofrequency ablation. Radiofrequency ablation for chronic rhinitis involves destruction of tissue in the posterior nasal nerve region. The procedure is thought to correct the imbalance of autonomic input to the nasal mucosa, reducing nasal antigen responses and vascular hyperreactivity.

The RhinAer Stylus is a handheld device designed for use under local anesthesia. The device delivers radiofrequency energy at a temperature of 60 degrees Celsius to the posterior nasal nerve region.

Comparators
The comparator of interest is medical management.

Options for the medical management of chronic rhinitis include allergen avoidance, nasal saline irrigation, and pharmacologic therapy (e.g., intranasal glucocorticoids, topical antihistamines, oral antihistamines, ipratropium).

For allergic rhinitis, treatment options include evaluation with appropriate allergy testing and the offering of immunotherapy.

Outcomes
The general outcomes of interest are symptoms, change in disease status, quality of life, and treatment-related morbidity.

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 above in Table 1 (see Background). Six months of follow-up is considered necessary to demonstrate efficacy. Adverse events can be assessed immediately (perioperative complications and postoperative pain) or over the longer term.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Randomized Controlled Trials
Stolovitsky et al. (2021) conducted an RCT comparing radiofrequency ablation using the RhinAer device with sham treatment.⁹ The trial enrolled 117 adults (age, 18 to 85 years; mean age, 57 years) with chronic rhinitis. Use of medication to treat chronic rhinitis was allowed in both groups (Table 11). Based on an intention to treat analysis that accounted for all randomized participants, after 3-months follow-up, the proportion of participants with a ≥ 30% improvement in rTNSS score was higher in the active radiofrequency ablation group (66.7%; 95% CI, 55.1% to 76.9%) than in the sham group (41.0%; 95% CI, 25.6% to 57.9%; p = .01). A similar number of participants in the active (9.1% [7/77]) and sham (12.8% [5/39])groups increased their medication use during the study (Table 12). The study was unblinded at 3 months, and individuals in the control group were allowed to crossover to the active intervention group.

Takashima et al. (2022) reported 12-month follow-up for patients (n = 77) initially randomized to the active intervention group.¹⁰ Study results for the active intervention group at 6- and 12-months are reported in Table 12. Treatment response and mean change from baseline remained stable through 12 months in the active intervention group, while concomitant medication use increased. The study is ongoing, with planned 3-year follow-up.

Table 11. RCT of Radiofrequency Ablation for Chronic Rhinitis — Characteristics

Table 12. RCT of Radiofrequency Ablation for Chronic Rhinitis — Results

The purpose of the study limitations tables (see Tables 13 and 14) is to display notable limitations identified in each study. This information is synthesized as a summary of the body of evidence following each table and provides the conclusions on the sufficiency of evidence supporting the position statement. The sole RCT has similar limitations as the cryotherapy RCT, including that the intended use population is unclear.

Table 13. Study Relevance Limitations

Table 14. Study Design and Conduct Limitations

Nonrandomized Studies
The effectiveness of radiofrequency ablation with the RhinAer device has been assessed in 2 industry-sponsored, nonrandomized, uncontrolled, open-label studies.^11,12 Both studies included patients with chronic rhinitis. Lee et al. (2022)¹¹ enrolled 129 patients and reported outcomes of radiofrequency ablation up to 6 months. Ehmer et al. (2021) enrolled 50 patients, 47 of whom had 1-year follow-up; 2-year results were subsequently reported in an extension study of 34 patients.^12,13 Study characteristics and results are summarized in Tables 15 and 16. Both studies found symptom response rates and the proportion of responders durable at time points ranging from 3 months to 2 years. Lee et al. reported quality of life outcomes using the miniRQLQ, a validated measure with an established MCID of 0.4 points. At 3 and 6 months post-treatment, the mean change in miniRQLQ scores from baseline was -1.6 and -1.8, respectively, indicating clinically important improvement in symptom-related quality of life. These studies are limited by nonrandomized, open-label designs and lack of control groups (Tables 17 and 18).

Table 15. Nonrandomized Studies of Radiofrequency Ablation for Chronic Rhinitis — Characteristics

Table 16. Nonrandomized Studies of Radiofrequency Ablation for Chronic Rhinitis — Results

Table 17. Study Relevance Limitations

Table 18. Study Design and Conduct Limitations

Section Summary: Radiofrequency Ablation
For individuals with chronic rhinitis who receive radiofrequency ablation, the evidence includes a RCT and 2 nonrandomized studies. Results from the RCT suggest that radiofrequency ablation is more effective than sham ablation in improving short-term rTNSS scores. Results from nonrandomized, uncontrolled studies also found radiofrequency ablation associated with improvements in rTNSS scores at timepoints up to 2 years, and symptom-related quality of life up to 6 months. Randomized controlled trials directly comparing radiofrequency ablation with medical management with follow-up for active and control groups ≥6 months are needed to confirm the efficacy of radiofrequency ablation for treatment of chronic rhinitis.

Laser Ablation for Chronic Rhinitis
Clinical Context and Therapy Purpose
Laser ablation is proposed as an alternative to medical management for patients with chronic rhinitis.

The following PICO was used to select literature to inform this review.

Population
The relevant population of interest is individuals with chronic allergic or nonallergic rhinitis.

Rhinitis is defined as symptomatic inflammation of the paranasal sinuses and nasal cavity. Chronic rhinitis is usually defined as rhinorrhea with or without nasal congestion symptoms despite medical therapy lasting longer than 3 months. Allergic rhinitis is defined as an IgE-mediated inflammatory response of the nasal mucous membranes after exposure to inhaled allergens. Symptoms include rhinorrhea (anterior or post nasal drip), nasal congestion, nasal itching, and sneezing. Allergic rhinitis can be seasonal or perennial, with symptoms being interittent or persistent.

Interventions
The therapy being considered is laser ablation. Laser ablation for chronic rhinitis involves destruction of tissue in the posterior nasal nerve region. The procedure is thought to correct the imbalance of autonomic input to the nasal mucosa, reducing nasal antigen responses and vascular hyperreactivity.

Comparators
The comparator of interest is medical management.

Options for the medical management of chronic rhinitis include allergen avoidance, nasal saline irrigation, and pharmacologic therapy (e.g., intranasal glucocorticoids, topical antihistamines, oral antihistamines, ipratropium).

For allergic rhinitis, treatment options include evaluation with appropriate allergy testing and the offering of immunotherapy.

Outcomes
The general outcomes of interest are symptoms, change in disease status, quality of life, and treatment-related morbidity.

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 above in Table 1 (see Background). Six months of follow-up is considered necessary to demonstrate efficacy. Adverse events can be assessed immediately (perioperative complications and postoperative pain) or over the longer term.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Nonrandomized studies
Krespi et al. (2020) conducted a nonrandomized study evaluating laser ablation for treatment of chronic rhinitis.¹⁴ The study enrolled 32 adults treated with an endoscopic diode laser in an outpatient setting. Duration of follow-up was 3 months. Mean rTNSS was reduced from 6.0 (standard deviation [SD], 0.7) at baseline to 2.3 (SD, 0.4) at 3-month follow-up. Adverse events were not reported. The study had multiple limitations, including the small sample size, uncontrolled design, and duration of follow-up less than 6 months. Randomized studies comparing laser ablation with medical management and with longer follow-up are needed to determine efficacy and safety.

Section Summary: Laser Ablation
Evidence on laser ablation for chronic rhinitis is limited to a single nonrandomized study with 3 months follow-up. Although laser ablation reduced rTNSS scores, additional studies are needed to determine the efficacy and safety of laser ablation for treatment of chronic rhinitis.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in Supplemental Information if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

No clinical practice guidelines on cryoablation, radiofrequency ablation, or laser ablation for chronic rhinitis were identified through clinical consultation or literature searches conducted through Dec. 7 , 2022.

American Academy of Allergy, Asthma, and Immunology
A 2020 practice parameter update on rhinitis from the American Academy of Allergy, Asthma, and Immunology did not address ablation techniques, including cryoablation, radiofrequency ablation, or laser ablation.¹⁵

American Rhinologic Society
A position statement issued by the American Rhinologic Society stated that posterior nasal nerve ablation, including cryoablation and radiofrequency ablation, should be considered as an effective option in treating chronic rhinitis and improving patient quality of life.¹⁶ Specific guidance on usage of these techniques was not issued.

U.S. Preventive Services Task Force Recommendations
Not applicable

Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this review are listed in Table 19.

Table 19. Summary of Key Trials

References 

1. Food & Drug Administration. Clarifix 510(k) Premarket Notification. 2019 (K190356) https://fda.report/PMN/K190356/19/K190356.pdf. Accessed December 7, 2022.
2. Food & Drug Administration. RhinAer (RHIN1 Stylus) 510(k) Premarket Notification. 2019 (K192471). Accessed December 7, 2022.
3. 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. PMID 30229670
4. 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. PMID 28799727
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. PMID 34355872
6. Chang MT, Song S, Hwang PH. Cryosurgical ablation for treatment of rhinitis: A prospective multicenter study. Laryngoscope. Aug 2020; 130(8): 1877-1884. PMID 31566744
7. 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. PMID 33616224
8. 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). 2021; 12: 2152656720988565. PMID 33598336
9. Stolovitzky JP, Ow RA, Silvers SL, et al. Effect of Radiofrequency Neurolysis on the Symptoms of Chronic Rhinitis: A Randomized Controlled Trial. OTO Open. 2021; 5(3): 2473974X211041124. PMID 34527852
10. 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. PMID 35714267
11. 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. PMID 35818709
12. 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. PMID 34382444
13. 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. PMID 35663498
14. Krespi YP, Wilson KA, Kizhner V. Laser ablation of posterior nasal nerves for rhinitis. Am J Otolaryngol. 2020; 41(3): 102396. PMID 31948695
15. Dykewicz MS, Wallace DV, Amrol DJ, et al. Rhinitis 2020: A practice parameter update. J Allergy Clin Immunol. Oct 2020; 146(4): 721-767. PMID 32707227
16. American Rhinologic Society. Posterior Nasal Nerve Ablation ARS Position Statement. January 2022. Accessed December 7, 2022.

Coding Section 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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