Latest Review Date: May 2024

Category: Surgery

POLICY:

Effective on and after July 31, 2023:

I.   Balloon sinus ostial dilation of the frontal, maxillary, or sphenoid sinuses may be considered medically necessary when all of the following criteria are met:

• Diagnosis of either of the following:
  • Recurrent acute rhinosinusitis defined as 4 or more documented, medically managed episodes in 1 year with symptom-free intervals between episodes; or 
  • Chronic sinusitis defined as greater than 12 weeks duration; 
     

AND

• Two or more of the following signs/symptoms:
  • Mucopurulent nasal drainage;
  • Nasal obstruction;
  • Facial pain, pressure and/or fullness over the affected sinus;
  • Decreased sense of smell; 

AND

• Other etiologies of symptoms have been ruled out or treated appropriately (e.g., allergies, nasal decongestant spray abuse (Afrin®), nasal septal deviation, dental pathology, immune disorders, intranasal tumors, polyps); AND
• ONE of the following: 
  • Tried and failed medical management for a minimum of 12 weeks including ALL of the following:
    • Nasal saline irrigation or nasal saline spray; and 
    • Intranasal corticosteroids for a minimum of 8 weeks, and
    • Two courses of oral antibiotics or one or more prolonged course of oral antibiotics for at least 21 days; OR
  • Documented intolerance, contraindication, or hypersensitivity to nasal saline, intranasal corticosteroids, antihistamine nasal spray/decongestants and antibiotics.

AND

• Evidence of abnormal findings on computerized tomography (CT) confirming diagnosis, including ALL of the following:
  • CT image is obtained AFTER medical management for a minimum of 12 weeks as described above; and
  • Image is read by a board-certified radiologist; and
  • Findings include ONE or MORE of the following:
    • Mucosal thickening >3 mm; or
    • Opacified sinus; or
    • Obstruction of the ostiomeatal complex;

AND

• Will be performed on the sinus identified by abnormal CT findings, as noted above.

II. Balloon sinus ostial dilation is considered investigational for all other indications due to the lack of clinical evidence demonstrating an impact on improved health outcomes, including, but not limited to:

• Isolated ethmoid sinus disease;
• Nasal polyposis, as a stand-alone treatment;
• Repeat balloon procedure in any of the sinuses to be treated;
• Samter’s triad (chronic condition defined by asthma, sinus inflammation with recurring nasal polyps, and aspirin sensitivity);
• Severe sinusitis secondary to autoimmune or connective tissue disorders including by not limited to sarcoidosis, granulomatosis with polyangiitis;
• Severe sinusitis secondary to ciliary dysfunction including by not limited to cystic fibrosis, Kartagener’s syndrome;
• Suspected or known benign or malignant sinonasal tumors.

DESCRIPTION OF PROCEDURE OR SERVICE:

Balloon ostial dilation (also known as balloon sinuplasty) is proposed as an alternative to traditional endoscopic sinus surgery for patients with chronic rhinosinusitis or recurrent acute rhinosinusitis who fail medical management. The procedure involves placing a balloon in the sinus ostium of the frontal, maxillary, or sphenoid sinuses and inflating the balloon to stretch the opening. It can be performed as a stand-alone procedure or as an adjunctive procedure to functional endoscopic sinus surgery (FESS). The goal of this technique, when used as an alternative to FESS, is to improve sinus drainage using a less invasive approach. When used as an adjunct to FESS, it is intended to facilitate and/or increase access to the sinuses.

Numerous devices have been cleared for marketing by the Food and Drug Administration (FDA) through the 510(k) process. Systems included the Relieva Seeker Balloon Sinuplasty System®, FinESS™ Sinus Treatment, XpreESS™ Multi-Sinus Dilation Tool, NuVent EM Balloon Sinus Dilation System, and the Ventera™ Sinus Dilation System.

DOCUMENTATION SUBMISSION:

Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization when prior authorization is required. In addition, the following documentation must also be submitted:

• Clinical notes describing the following:
  1. Signs/symptoms of chronic or acute rhinosinusitis including duration of symptoms; AND
  2. Work up that has excluded other etiologies for sinus symptoms; AND
  3. Specific treatments, including duration and results.
• Report of sinus computerized tomography (CT) imaging on the sinus intended for the procedure, performed after all maximum medical therapy.
• Confirmation that the CT imaging report was read by a board-certified radiologist.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Covered if covered by the participating home plan

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:

POLICY HISTORY

Reviewed and posted July 1, 2021.

May 2022: Annual review completed. No change to policy intent.

June 2023:  Annual review completed. Policy statement updated with removal for other etiologies of symptoms and one of the following [Antihistamine nasal spray or decongestant (oral or nasal)]. Policy on draft June 16, 2023 through July 30, 2023.

June 2024: Annual review completed. No change to policy 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.