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Cryoablation, Radiofrequency, and Laser Treatment for Chronic Rhinitis or Nasal Obstruction
Policy Number: MP-744
Latest Review Date: February 2025
Category: Surgery
DRAFT
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.
Radiofrequency volumetric tissue reduction for nasal obstruction due to internal nasal valve collapse is considered investigational.
DESCRIPTION OF PROCEDURE OR SERVICE:
Chronic Rhinitis
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 individuals 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. 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 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. Adverse events must be assessed immediately (perioperative complications and postoperative pain) and 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. |
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]). |
SNOT-20: change in score of 0.8 or greater |
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 |
|
Visual analog scale (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 |
Nasal Obstruction
Nasal obstruction is defined clinically as a patient symptom that presents as a sensation of reduced or insufficient airflow through the nose. Nasal valve collapse (NVC) is a readily identifiable cause of nasal obstruction. Specifically, the internal nasal valve represents the narrowest portion of the nasal airway with the upper lateral nasal cartilages present as supporting structures. The external nasal valve is an area of potential dynamic collapse that is supported by the lower lateral cartilages. Damaged or weakened cartilage will further decrease airway capacity and increase airflow resistance and may be associated with symptoms of obstruction. Patients with NVC may be treated with nonsurgical interventions in an attempt to increase the airway capacity but severe symptoms and anatomic distortion are treated with surgical cartilage graft procedures. The application of radiofrequency volumetric tissue reduction for nasal obstruction has been proposed as a less invasive means to treat nasal obstruction due to internal NVC. By utilizing RF energy, the treatment aims to provide relief with reduced recovery times and fewer complications compared to traditional surgical methods.
Nasal obstruction is defined clinically as a patient symptom that presents as a sensation of reduced or insufficient airflow through the nose. Commonly, patients will feel that they have nasal congestion or stuffiness. In adults, clinicians focus on the evaluation of important features of the history provided by the patient such as whether symptoms are unilateral or bilateral. Unilateral symptoms are more suggestive of structural causes of nasal obstruction. A history of trauma or previous nasal surgery, especially septoplasty or rhinoplasty, is also important. Diurnal or seasonal variation in symptoms is associated with allergic conditions.
Nasal valve collapse (NVC) is a readily identifiable cause of nasal obstruction. The internal nasal valve is the narrowest part of the nasal passage and is supported by the upper lateral nasal cartilages (see pathophysiology below). On the other hand, the external nasal valve, also known as the nasal entrance, is prone to dynamic collapse and is supported by the lower lateral cartilages. When cartilage is damaged or weakened, it can reduce airway capacity, increase airflow resistance, and lead to symptoms of obstruction. While nonsurgical treatments aim to enhance airway capacity in patients with NVC, severe symptoms and significant anatomical distortion typically require surgical cartilage graft procedures.
Etiology
Nasal obstruction associated with the external nasal valve is commonly associated with post-rhinoplasty or traumatic sequelae and may require functional rhinoplasty procedures. A common cause of internal nasal valve collapse is a septal deviation. Prior nasal surgery, nasal trauma, and congenital anomaly are additional causes.
Pathophysiology
The internal nasal valve, bordered by the collapsible soft tissue between the upper and lower lateral cartilages, the anterior end of the inferior turbinate, and the nasal septum, forms the narrowest part of the nasal airway. During inspiration, the lateral wall cartilage is dynamic and draws inward toward the septum and the internal nasal valve narrows providing protection to the upper airways. Given that the internal nasal valve accounts for at least half of the nasal airway resistance; even minor further narrowing of this area can lead to symptomatic obstruction for a patient. Damaged or weakened lateral nasal cartilage will further decrease airway capacity of the internal nasal valve area, increasing airflow resistance and symptoms of congestion.
Physical Examination
A thorough physical examination of the nose, nasal cavity, and nasopharynx is generally sufficient to identify the most likely etiology for the nasal obstruction. Both the external and internal nasal valve areas should be examined. The external nasal valve is at the level of the internal nostril. It is formed by the caudal portion of the lower lateral cartilage, surrounding soft tissue, and the membranous septum.
The Cottle maneuver is an examination in which the cheek on the symptomatic side is gently pulled laterally with 1 to 2 fingers. If the patient is less symptomatic with inspiration during the maneuver, the assumption is that the nasal valve has been widened from a collapsed state or dynamic nasal valve collapse. An individual can perform the maneuver on oneself and it is subjective. A clinician performs the modified Cottle maneuver. A cotton swab or curette is inserted into the nasal cavity to support the nasal cartilage and the patient reports whether there is an improvement in the symptoms with inspiration. In both instances, a change in the external contour of the lateral nose may be apparent to both the patient and the examiner.
According to American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS, 2023):
- "The diagnosis of symptomatic nasal valve dysfunction is a clinical diagnosis, made by patient history and physical exam. These diagnoses are made by a qualified Otolaryngologist as a part of a thorough physical examination of the nose...Subjective improvement in nasal breathing with the Cottle or modified Cottle maneuver confirms the diagnosis of nasal valve collapse."
Treatment
Treatment of symptomatic nasal valve collapse includes the use of non-surgical interventions such as the adhesive strips applied externally across the nose or use of nasal dilators, cones, or other devices that support the lateral nasal wall internally applying the principle of the modified Cottle maneuver. Severe cases of obstruction resulting from nasal valve deformities are treated with surgical grafting to widen and/or strengthen the valve. Common materials include cartilaginous autografts and allografts, as well as permanent synthetic grafts. Cartilage grafts are most commonly harvested from the patient’s nasal septum or ear.
Radiofrequency Volumetric Tissue Reduction
The application of low-dose radiofrequency (RF) energy has been proposed as an alternative technique for reshaping nasal tissue to address NVC. This method has been suggested as a viable alternative to more invasive grafting procedures, particularly for patients experiencing severe nasal obstruction. By utilizing RF energy, the treatment aims to provide relief with reduced recovery times and fewer complications compared to traditional surgical methods.
KEY POINTS:
This evidence review was created with a search of the PubMed database. The most recent literature update was performed through December 18, 2024.
Summary of Evidence
Chronic Rhinitis
For individuals with chronic rhinitis who receive cryoablation, the evidence includes a randomized controlled trial (RCT) and non-randomized studies. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. One RCT that compared cryoablation using the ClariFix device with a sham procedure showed a statistically significant difference in response rate in favor of cryoablation group compared to the sham group. However, it is unclear if the trial enrolled individuals with chronic rhinitis who were refractory to medical management. This limitation precludes meaningful interpretation of these results as the intended use of ClariFix device is for individuals with chronic rhinitis who are refractory to medical management. Three single-arm prospective studies evaluated efficacy and safety of cryoablation for patients with chronic rhinitis. Two (of 3) studies enrolled individuals who were refractory to medical management. The definition of refractory varied from symptoms not adequately controlled with a minimum of 4 weeks of topical nasal steroid treatment or failure of medical therapy fora duration of at least 3 months. Although all 3 single arm studies reported improvement in symptom control, the major limitation is lack of a comparator group and open-label nature of the study design, which likely introduces biases. Additionally, loss to follow-up was high. RCTs with a clearly defined refractory patient population directly comparing cryoablation with sham surgery or other surgical interventions are needed to confirm the efficacy of cryoablation for treatment of chronic rhinitis. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals with chronic rhinitis refractory to medical management who receive radiofrequency ablation, the evidence includes an RCT and non-randomized studies. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. One RCT that compared radiofrequency using the RhinAer device with a sham procedure showed a statistically significant difference in response rate in favor of radiofrequency ablation group compared to the sham group. However, it is unclear if the trial enrolled individuals with chronic rhinitis who were refractory to medical management. This limitation precludes meaningful interpretation of these results as the intended use of RhinAer device is for individuals with chronic rhinitis who are refractory to medical management. Two single-arm prospective studies evaluated efficacy and safety of radiofrequency ablation for patients with chronic rhinitis. One (of 2) studies enrolled individuals who were refractory to medical management. Although both single arm studies reported improvement in symptom control, the major limitation is lack of a comparator group and open-label nature of the study design, which likely introduces biases. RCTs with a clearly defined refractory patient population directly comparing radiofrequency with sham surgery or other surgical interventions 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.
For individuals with allergic or nonallergic chronic rhinitis who receive laser ablation, the evidence includes one non-randomized study. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Although the single-arm prospective study reported improvement in symptom control, the major limitation is lack of a comparator group and open-label nature of the study design, which likely introduces biases. In addition, the authors did not define how study participants were classified as refractory to medical management. RCTs with a clearly defined refractory patient population directly comparing laser ablation with sham surgery or other surgical interventions 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.
Nasal Obstruction
For individuals with symptomatic nasal obstruction due to internal nasal valve collapse who receive radiofrequency volumetric tissue reduction (RFVTR), the evidence includes systematic reviews and a randomized controlled trial (RCT) with 12-month and 24-month uncontrolled follow-up phases. Relevant outcomes are symptoms, change in disease status, treatment-related morbidity, functional outcomes, and quality of life. Systematic reviews have generally shown improvements in nasal obstruction scores. In the RCT, follow-up at 3 months revealed a statistically significant improvement in response with the RFVTR procedure compared to the sham group. However, these results are limited by the small study size, lack of diversity, short duration, and failure to control for confounding factors such as medication or nasal dilator use. Moreover, the trial's results may not fully represent the potential effect of RFVTR since treatment was limited to lateral nasal wall repair, not addressing soft tissues like septal swell bodies and inferior turbinates. A significant and durable effect on nasal obstruction post-RFVTR treatment was reported up to 24 months during the uncontrolled crossover phase of the trial. Additional RCTs with extended follow-up periods, larger and more diverse populations, and comparisons of RFVTR to other treatments (medications, nasal dilators, and rhinoplasty) are necessary to confirm the procedure's efficacy for nasal obstruction. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Practice Guidelines and Position Statements
Chronic Rhinitis
American Academy of Allergy, Asthma, and Immunology
The 2023 International Consensus Statement on Allergy and Rhinology stated the following for cryotherapy/radiofrequency ablation of posterior nasal nerve.
- Aggregate grade of evidence: C (Level 3: 2 studies, level 4: 4 studies, level 5: 5 studies)
- Benefit: Improvement in rhinorrhea.
- Harm: Risk of complications (e.g., epistaxis, temporary facial pain and swelling, headaches), limited long-term results.
- Cost: Surgical/procedural costs, cost of device, potential time off from work.
- Benefits-harm assessment: Potential benefit must be balanced with low risk of harm, especially considering limited long-term results.
- Value judgments: Patients may experience an improvement in symptoms.
- Policy level: Option.
- Intervention: Cryoablation and radiofrequency ablation of the posterior nasal nerve may be considered in allergic rhinitis patients that have failed medical management, particularly for rhinorrhea.
Grade of evidence "C" implies that body of evidence consisted of observational studies (case control and cohort design). Policy level "Option" implies "either that the evidence quality that exists is suspect or that well-designed, well conducted studies have demonstrated little clear advantage to one approach versus another. Options offer clinicians flexibility in their decision-making regarding appropriate practice, although they may set boundaries on alternatives. Patient preference should have a substantial role in influencing clinical decision-making, particularly when policies are expressed as options." As per the consensus statement, "because the current evidence is primarily based on industry-sponsored studies with limited long-term data, these office-based interventions remain an option for properly selected patients."
American Academy of Otolaryngology
In January 2023, the American Academy of Otolaryngology issued a position statement on peripheral nerve ablation for the treatment of chronic rhinitis. The position statement was not based on a systematic review or strength of evidence rating. According to the position statement, "Based on these safety and efficacy data, the American Academy of Otolaryngology endorses the use of posterior nasal nerve ablation for the treatment of medically-refractory chronic rhinitis. We do not consider these treatments to be experimental."
American Rhinologic Society
In January 2022, the American Rhinologic Society issued a position paper on posterior nasal nerve ablation. The position statement was not based on a systematic review or strength of evidence rating. According to the position statement, "The American Rhinologic Society supports the use of posterior nasal nerve ablation for the treatment of chronic rhinitis, including both allergic and non-allergic subtypes. This procedure should not be considered experimental, but should be considered as an effective option in treating chronic rhinitis and improving patient quality of life in those suffering from rhinorrhea and nasal congestion based on the following data."
Nasal Obstruction
American Academy of Otolaryngology-Head Neck Surgery
In 2023, the American Academy of Otolaryngology-Head Neck Surgery (AAO-HNS) issued a position statement on nasal valve repair stating that treatment options of nasal valve dysfunction may include implants aimed at stabilizing the nasal valve. With regards to surgical repair of the nasal valve, the AAO-HNS states:
- "The treatment of nasal valve dysfunction may involve techniques that include cartilage grafting and open surgical repair, suture suspension techniques, and implants or radiofrequency treatment aimed at stabilizing the nasal valve…The nasal valve may be stabilized using office-based treatments, such as implants or radiofrequency treatment. For patients who require anatomic widening and definitive stabilization of the nasal valve, surgical treatment of nasal valve collapse, along with treatment of other possible causes of nasal airway obstruction, is required to optimize patient outcomes. Failure to perform nasal valve repair, when indicated, is a common cause of incomplete symptom resolution for patients with nasal obstruction and nasal valve dysfunction."
U.S. Preventive Services Task Force Recommendations
Not applicable.
KEY WORDS:
Cryoablation, Cryosurgical ablation, cryosurgery, Chronic Rhinitis, ClariFix® (Arrinex), RhinAer® stylus, Radiofrequency ablation, Laser ablation, nasal obstruction, VivAer stylus
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. 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. Asper 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.
In April 2020, the VivAer® Stylus (Aerin Medical) was cleared for use in otorhinolaryngology (ENT) surgery by the FDA through the 510(k) process as a tool to treat nasal obstruction (K200300). Clearance was based on equivalence in design and intended use of a predicate device, the Vivaer® ARC Stylus (K172529). The VivAer® Stylus is functionally unchanged from the predicate in design and intended use to generate and deliver bipolar RF energy to treat tissue in otorhinolaryngology (ENT) procedures. As per the FDA 510K summary, the VivAer® Stylus is indicated for use in ENT surgery for the coagulation of soft tissue in the nasal airway, to treat nasal airway obstruction by shrinking submucosal tissue, including cartilage in the internal nasal valve area.
The VivAer® Stylus is distinct from the RhinAer® device (Aerin Medical) as it targets nasal tissue for remodeling to improve airflow as opposed to disrupting the posterior nasal nerve in 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 |
30469 | Repair of nasal valve collapse with low energy, temperature-controlled (ie, radiofrequency) subcutaneous/submucosal remodeling |
31242 |
Nasal/sinus endoscopy, surgical; with destruction by radiofrequency ablation, posterior |
31243 |
Nasal/sinus endoscopy, surgical; with destruction by cryoablation, posterior nasal |
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:
- American Academy of Otolaryngology. Position Statement: PNN ablation for the treatment of chronic rhinitis. January 2023.
- American Academy of Otolaryngology-Head and Neck Surgery. Position Statement: Nasal Valve Repair, 2023; https://www.entnet.org/resource/position-statement-nasal-valve-repair/.
- American Rhinologic Society. Posterior Nasal Nerve Ablation ARS Position Statement. January 2022.
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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: 2024 Annual Coding Update. Added CPT codes 31242 and 31243 to the Current Coding section. New codes effective 01/01/24.
Medical Policy Panel, March 2024
Medical Policy Group, April 2024 (9): Updates to Description, Key Points; Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. No change to Policy Statement.
Medical Policy Panel, February 2025
Medical Policy Group, February 2025 (3): Updates to Policy Statement, Description, Key Points, Key Words, Approved by Governing Bodies, Current Coding (+30469) and References. Title updated to Cryoablation, Radiofrequency, and Laser Treatment for Chronic Rhinitis or Nasal Obstruction. Policy statement updated to include non-coverage of radiofrequency volumetric tissue reduction for nasal obstruction, previously non-covered per MP 495 Investigational Criteria. On DRAFT 3/1/25-4/15/25.
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.