Related Medicare Advantage Medical/Pharmacy Coverage Policies

Sinuva (mometasone furoate) sinus implant Pharmacy Coverage Policy

Related Documents

Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/Transmittals.

There are no NCD and/or LCDs for Balloon Dilation (Eustachian Tube and Sinus), Functional Endoscopic Sinus Surgery, and RhinAer.

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Description

Rhinosinusitis is an inflammatory condition of the cavities around the sinuses (nasal passages) which causes them to become swollen. It can be further classified as acute (isolated episode), recurrent acute (four or more occurrences in one year) or chronic (lasting longer than 12 weeks despite medical management). For an individual who experiences persistent symptoms despite medical management, surgical intervention of the sinus cavities may be necessary. Chronic rhinosinusitis is more difficult to accurately diagnose in children and adenoidectomy is primarily used as the first-line surgical treatment.29

Balloon sinus ostial dilation, or balloon sinuplasty is an outpatient treatment option for an individual diagnosed with recurrent acute or chronic rhinosinusitis. Endoscopic instruments are used to open the passages of the sinus ostia and paranasal spaces without cutting bone or removing tissue. Under local anesthesia, the surgeon inserts a small balloon through a tube placed in the nasal cavity where the blocked sinus is located. Using fluoroscopic guidance, the balloon is gradually inflated, deflated and then removed. The compression of soft bone and swollen tissue creates additional space and facilitates the drainage of mucus. The surgeon may assess the nasal passages with an endoscope following the procedure to confirm width.

Examples of these devices include, but may not be limited to:

• NuVent EM Dilation System
• VenSure Balloon
• Vent-Os Sinus Dilation System
• Ventera Sinus Dilation System

Functional endoscopic sinus surgery (FESS) is a minimally invasive surgical procedure intended to restore sinus ventilation and drainage by removal of diseased tissue and bone, which can facilitate the gradual resolution of mucosal disease. FESS is generally considered a standard of care for treating recurrent acute or chronic rhinosinusitis that has not responded to medical treatment. However, because FESS does not directly treat the underlying inflammatory disorder, sinus surgery must be followed by medical management to control inflammatory processes or symptoms will invariably return. Endoscopic sinus surgical procedures may occur in the ethmoid, frontal, maxillary and sphenoid sinuses.

Drug-eluting sinus stents are implantable devices placed to expand and prop open the sinus, support the bony structures inside the nose and are purported to prevent scar formation. Drug-eluting sinus stents (eg, mometasone furoate sinus implant), deliver a sustained, localized, controlled release of a corticosteroid which dissolves over time. Currently, the stents are being placed following surgery of the ethmoid, frontal and/or maxillary sinus cavities. Examples of these devices include, but may not be limited to, Propel, Propel Mini and Propel Contour.

For information regarding Sinuva sinus implant coverage determination/limitations, please refer to Sinuva (mometasone furoate) sinus implant Pharmacy Coverage Policy.

The Eustachian tube (ET)

is a narrow passage that links the nasopharynx (back of the nose) to the middle ear. The functions of the ET include balancing middle ear pressure, protecting the middle ear from infection and nasal drainage, and allowing drainage of middle ear secretions.

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Eustachian tube dysfunction is described as failure of the functional valve of the Eustachian tube to open and/or close properly, resulting in inadequate ventilation to the middle ear. This dysfunction may lead to either obstructive or patulous pathology.

Balloon dilation of the Eustachian tube (BDET) is a procedure intended to dilate (widen) the cartilaginous portion of the Eustachian tube to treat persistent obstruction. Along with the procedure, a nasopharyngoscopy may be performed to evaluate whether there are any anatomic challenges that may complicate the procedure or require additional surgical intervention. The guide catheter is used to access the ET through the nose. The clinician then threads the balloon catheter through the guide catheter and inflates the balloon (via injection of saline or sterile water), which purportedly opens a pathway for mucus and air to flow through the ET. Once the ET is dilated, the balloon is deflated and removed. Examples of these devices include, but may not be limited to:

• AERA Eustachian Balloon Dilation System
• NuVent Eustachian Tube Dilation Balloon

RhinAer is a noninvasive procedure that purportedly treats chronic rhinitis by destroying inflamed soft tissue and disrupting the posterior nasal nerve signals that are thought to cause excess mucus production and congestion.

A probe is inserted intranasally that administers low-temperature radiofrequency energy to ablate the posterior nasal nerve and reduce inflamed soft tissue.

Coverage Determination

Humana follows the CMS requirement that only allows coverage and payment for services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following:

Balloon Dilation of the Eustachian Tube (BDET)

BDET will be considered medically reasonable and necessary when the following requirements are met:

• Documentation indicates failure of conservative therapy (eg, over-the-counter oral medications, nasal sprays); AND
• Documentation shows signs and symptoms of Eustachian tube dysfunction (eg, changes in hearing, ear pain, ringing in the ear)

Balloon Sinus Ostial Dilation

Balloon sinus ostial dilation will be considered medically reasonable and necessary when all of the following requirements are met:

• Balloon dilation is limited to the frontal, maxillary and/or sphenoid sinuses; AND
• The system is used according to the FDA-approved indications for age and sinus cavities; AND
• Documentation of rhinosinusitis as EITHER:
  • Chronic rhinosinusitis (greater than 12 consecutive weeks); OR
  • Recurrent acute rhinosinusitis (4 or more occurrences in 1 year);
  AND ALL of the following:
  • Documented failure of medical therapy demonstrated by persistent upper respiratory symptoms despite treatment consisting of the following:
    • Antibiotic therapy if bacterial infection is suspected; AND
    • Appropriate environmental controls, antihistamine nasal spray (eg, Astepro, Patanase) and/or allergen immunotherapy (eg, injections); AND
    • Intranasal or oral corticosteroids;
    AND
  • Radiographic confirmation following the treatments noted above which demonstrate one or more of the following:
    • Infection/sinusitis of the affected sinus(es); OR
    • Obstruction within the affected sinus(es); OR
    • Surrounding anatomy contributing to obstruction of the affected sinus(es)

Balloon sinus ostial dilation used adjunctively during functional endoscopic sinus surgery (FESS) in the same sinus cavity is considered integral to the primary procedure and not separately reimbursable.

Functional Endoscopic Sinus Surgery (FESS)

FESS will be considered medically reasonable and necessary when the following requirements are met:

• Acute complications of rhinosinusitis confirmed by computerized tomography (CT) scan or diagnostic endoscopic exam, consisting of one or more of the following:
  • Abscess (epidural, intracerebral, orbital, subdural, subperiosteal); OR
  • Cavernous sinus thrombosis; OR
  • Cellulitis (orbital, preseptal); OR
  • Frontal bone osteomyelitis; OR
  • Meningitis; OR
• Allergic fungal sinusitis and ALL of the following:
  • Nasal airway obstruction; AND
  • Positive findings on CT scan (eg, fungal ball); OR
• Chronic sinus polyposis creating nasal obstruction which is unresponsive to medical treatment for at least 4 consecutive weeks (eg, antibiotics, nasal steroids); OR
• Documentation of rhinosinusitis as EITHER:
  • Chronic rhinosinusitis (greater than 12 consecutive weeks); OR
  • Recurrent acute rhinosinusitis (4 or more occurrences in 1 year);
  AND ALL of the following:
  • Documented failure of medical therapy demonstrated by persistent upper respiratory symptoms despite treatment consisting of ALL of the following:
    • Antibiotic therapy if bacterial infection is suspected; AND
    • Appropriate environmental controls, antihistamine nasal spray (eg, Astepro, Patanase) and/or allergen immunotherapy (eg, injections); AND
    • Intranasal or oral corticosteroids;
    AND
  • Radiographic confirmation following the treatments noted above which demonstrate one or more of the following:
    • Infection/sinusitis of the affected sinus(es); OR
    • Obstruction within the affected sinus(es); OR
    • Surrounding anatomy contributing to obstruction of the affected sinus(es); OR
• Foreign body removal; OR
• Mucoceles; OR
• Posterior epistaxis, uncontrolled; OR
• Recurrent sinusitis (4 or more occurrences in 1 year) that triggers or aggravates pulmonary disease (eg, asthma, cystic fibrosis); OR
• Tumors suspected via CT scan, diagnostic endoscopy or physical examination

Nasal sinus debridement after FESS will be considered medically reasonable and necessary.

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Repeat FESS following failure of a previous sinus surgical procedure will be considered medically reasonable and necessary.

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms.

Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage

SINUS TREATMENTS

The following sinus treatments will not be considered medically reasonable and necessary:

• Balloon sinus ostial dilation for the ethmoid sinuses; OR
• Drug-eluting sinus stents (eg, Propel, Propel Mini, Propel Contour); OR
• RhinAer procedure

A review of the current medical literature shows that the evidence is insufficient to determine that these services are standard medical treatments. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of these services in clinical management.

Summary of Evidence

Randomized control trials (RCTs) show the effectiveness of balloon sinus ostial dilation in single-cell sinus cavities (eg, frontal, maxillary, sphenoid); however, available study results do not support the use in the ethmoid sinus which has multiple cells with an intricate structure through which the paranasal sinuses drain.23 Clinical study results are limited to efficacy data regarding balloon sinus ostial dilation of the frontal, maxillary and sphenoid sinuses. Although improvement in chronic rhinosinusitis has been demonstrated, available study results are limited and are at risk for bias due to sponsorship by manufacturers of the balloon catheters.43

A recent systematic review showed improved Sino-Nasal Outcome Test (SNOT-22) scores for patients treated with drug-eluting sinus stents as compared to topical medication treatment for chronic rhinosinusitis. However, scores did not differ statistically at 3-month follow-up studies. Two RCTs showed risk for bias and small study size that included too few individuals to be conclusive.24 There remains a lack of longer-term unbiased RCTs with comparative data between drug-eluting sinus stents and medication therapy demonstrating the safety and efficacy of drug-eluting sinus stents for the treatment of chronic rhinosinusitis.28

Available evidence from one RCT and two case studies suggest that RhinAer may be safe and effective in treating chronic rhinosinusitis symptoms in most individuals after treatment. However, the difference in symptom improvement between RhinAer and sham treatment at three-month follow-up is not statistically significant enough to arrive at a definitive conclusion.25 There remains a lack of longer-term unbiased RCTs with comparative data for RhinAer versus conventional or alternative procedures.29

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