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Cryoablation, Radiofrequency Ablation and Laser Ablation for Treatment of Chronic Rhinitis

Policy Number: MP-744

Latest Review Date: February 2023              

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:

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 have been investigated for patients with chronic rhinitis refractory to multiple medical therapies. 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.

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.

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

Outcome

Measures

Description

Minimal Clinically Important Difference

Timing

Symptoms

reflective Total Nasal Symptom Score (rTNSS)

Sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0 = none, 1 = mild, 2 = moderate, or 3 = severe.
Maximum 12 points.

Not established; 30% change from baseline has been proposed

At least 6 months or longer

The Chronic Sinusitis Survey (CSS)

Measure of symptoms and medication usage over an 8-week recall period. Includes 3 questions regarding symptoms and 3 regarding medication usage, yielding a total score, symptom subscore, and medication subscore. Ranges from 0 to 100 in which a low CSS score represents greater symptoms and/or medication usage.

Not established

At least 6 months or longer

Visual Analog Scale (VAS)

Patient-reported.

Not established

At least 6 months or longer

Disease-Specific Quality of Life

Sino-Nasal Outcome Test-20 (SNOT-20)

Patients complete 20 symptom questions on a categorical scale (0 [no bother] to 5 [worst symptoms can be]).

Average rankings can be reported over all 20 symptoms, as well as by 4 subclassified symptom domains.
The possible range of SNOT-20 scores is 0 to 5, with a higher score indicating a greater rhinosinusitis-related health burden.
SNOT-22, a variation of the SNOT-20, includes 2 additional questions (on “nasal obstruction” and “loss of smell and taste”).

SNOT-20: change in score of 0.8 or greater

SNOT-22: change in score of 8.9 points

At least 6 months or longer

Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

Measures the functional (physical, emotional, and social) problems associated with rhinitis.

Not established

At least 6 months or longer

VAS

Patient-reported.

Not established

At least 6 months or longer

Adverse events

Various; patient- and clinician reported

Potential procedure- and device-related adverse events include postoperative pain, epistaxis, and dry eyes.

Not applicable

Immediately post procedure to 6 months or longer

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 7, 2022.

Summary of Evidence

For individuals with chronic rhinitis who receive cryoablation, the evidence includes a randomized controlled trial (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 used a sham control group, and follow-up was limited to 3 months. Randomized controlled trials with a clearly defined patient population directly comparing cryoablation with medical management and with follow-up for active and control groups ≥6 months are needed to confirm the efficacy of cryoablation for treatment of chronic rhinitis. A systematic review of 15 nonrandomized studies reported improvements with cryoablation; however, only 1 study used an approved device and validated outcome measuring, limiting conclusions from this systematic review. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with chronic rhinitis who receive radiofrequency ablation, the evidence includes an RCT and 2 nonrandomized studies. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Results from the RCT suggest that radiofrequency ablation is more effective than sham ablation in improving short-term reflective Total Nasal Symptom Score (rTNSS) scores. Results from nonrandomized, uncontrolled studies also found radiofrequency ablation associated with improvements in rTNSS scores at time points up to 2 years and in symptom-related quality of life up to 6 months. Randomized controlled trials with a clearly defined patient population directly comparing radiofrequency ablation with medical management and with follow-up for active and control groups ≥6 months 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.

Evidence on laser ablation for chronic rhinitis is limited to a single small nonrandomized study with 3 months follow-up. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Although laser ablation reduced rTNSS scores, additional studies are needed to determine the efficacy and safety of laser ablation for treatment of chronic rhinitis. Randomized controlled trials with a clearly defined patient population directly comparing laser ablation with medical management and with follow-up for active and control groups ≥6 months are needed to confirm the efficacy of laser 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

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

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. Specific guidance on usage of these techniques was not issued.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Cryoablation, Cryosurgical ablation, cryosurgery, Chronic Rhinitis, ClariFix® (Arrinex), NEUROMARK® System (Neurent Medical) , NEUROMARK® Device, NEUROMARK® Console, 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.

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.

In October 2022, NEUROMARK® System (Neurent Medical) was cleared by the FDA through the 510(k) process(K22032). It is for the use in otorhinolaryngology [also known as Ear, Nose and Throat (ENT)} surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in individuals 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:

30999

Unlisted procedure, nose

30117

Excision or destruction (eg, laser), intranasal lesion; internal approach

31242 Nasal/sinus endoscopy, surgical; with destruction by radiofrequency ablation, posterior
nasal nerve (Effective 01/01/24)
31243 Nasal/sinus endoscopy, surgical; with destruction by cryoablation, posterior nasal
nerve (Effective 01/01/24)

31299

Unlisted procedure, accessory sinuses

PREVIOUS CODING:

C9771

Nasal/sinus endoscopy, cryoablation nasal tissue(s) and/or nerve(s), unilateral or bilateral (Deleted 12/31/23)

REFERENCES:

  1. American Rhinologic Society. Posterior Nasal Nerve Ablation ARS Position Statement. January 2022. Accessed December 7, 2022.
  2. Chang MT, Song S, Hwang PH. Cryosurgical ablation for treatment of rhinitis: A prospective multicenter study. Laryngoscope. Aug 2020; 130(8): 1877-1884.
  3. 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.
  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. Dykewicz MS, Wallace DV, Amrol DJ, et al. Rhinitis 2020: A practice parameter update. J Allergy Clin Immunol. Oct 2020; 146(4): 721-767.
  6. 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.
  7. 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.
  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. Food & Drug Administration. Clarifix 510(k) Premarket Notification. 2019 (K190356) https://fda.report/PMN/K190356/19/K190356.pdf. Accessed August 16, 2021.
  10. 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.
  11. 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.
  12. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  13. 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.
  14. 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.
  15. Lieberman P.L.. Chronic nonallergic rhinitis. In: UpToDate, Corren J (Ed), UpToDate, Waltham, MA. https://www.uptodate.com/contents/chronic-nonallergic-rhinitis. Accessed August 17, 2021.
  16. 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.
  17. 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.

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:  Update to Key Words and Approved by Governing Bodies to include NEUROMARK®.  2024 Annual Coding Update.  Added CPT codes 31242 and 31243 to the Current Coding section. New codes effective 01/01/24. Updated Previous Coding section to include code C9771.

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.