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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.

I.   Balloon sinus ostial dilation of the frontal, maxillary, or sphenoid sinuses may be considered MEDICALLY NECESSARY AND APPROPRIATE 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 with medical management; 
• 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
    • Antihistamine nasal spray or decongestant (oral or nasal); 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 EXPERIMENTAL/INVESTIGATIVE for all other indications due to a 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.

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.

Link to Pre-Authorization Form: https://www.bluecrossmn.com/sites/default/files/DAM/2021-12/BCBSMN-Pre-Auth-Request-fillable-X18509R07.pdf