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

POLICY NUMBER

A.7.01.168

DESCRIPTION

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 the table below. 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.

Outcome Measures for Chronic Rhinitis Interventions

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. As per 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.

Related medical policies - 

• Balloon Ostial Dilation for Treatment of Chronic Rhinosinusitis

• Steroid-Eluting Sinus Stents and Implants

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.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

05/15/2022: New policy added. Approved by the Medical Policy Advisory Committee.

03/21/2023: Policy description updated regarding ablation therapy. Policy statements unchanged.

12/21/2023: Code Reference section updated to add new 2024 CPT codes 31242 and 31243, effective 01/01/2024.

04/22/2024: Policy description updated regarding interventions for chronic rhinitis and devices. Policy statements unchanged.

04/14/2025: Policy reviewed. Policy statements unchanged. Code Reference section updated to remove deleted HCPCS code C9771.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.168

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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