7.01.163 Absorbable Nasal Implant for Treatment of …The internal nasal valve, bordered by the...

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Revista Cubana de Ortopedia y Traumatología. 2014; 28(1): 14-25 http://scielo.sld.cu 14 ARTÍCULO ORIGINAL Estudio biomecánico hueso-implante DHS y fijador externo en la consolidación de la fractura de cadera Biomechanical study of bone-DHS implant and external fixator in hip fracture Étude biomécanique de la vis-plaque dynamique (DHS) et du fixateur externe dans la consolidation de la fracture de hanche Dr.C. Roberto Andrés Estrada Cingualbres, I MSc. Yoan Manuel Ramos Botello, II MSc. Jorge Alexander Bosch Cabrera II I Centro de Estudios CAD/CAM. Universidad de Holguín, Cuba. II Facultad de Ciencias Técnicas. Universidad de Granma, Cuba. RESUMEN Objetivos: determinar el comportamiento biomecánico de los conjuntos placa Dinámic Hip Screw-hueso y fijador externo monolateral-hueso y la influencia de estos en la distribución del estado tensional, antes, durante y después de retirado el implante. Métodos: se realizó el estudio aplicando el método de los elementos finitos, se tuvo en cuenta la acción de los músculos y el peso corporal en la fase monopodal del ciclo de marcha, así como las propiedades anisotrópicas en el tejido cortical, e isotrópicas para la parte esponjosa del hueso. Se ejecutó un estudio comparativo del estado tensional del implante y su influencia en la variación del estado tensional- deformacional del hueso, durante el tiempo en que se mantiene el implante en este y luego de ser retirado Resultados: se obtuvo la variación porcentual de las zonas sometidas a tracción y compresión en el hueso sano durante el estado de carga correspondiente a la marcha monopodal, el valor de las tensiones actuantes en cada elemento de los implantes analizados durante la consolidación de la fractura, así como la influencia de estos en la distribución del estado tensional del hueso, durante su funcionamiento y después de retirado el implante.

Transcript of 7.01.163 Absorbable Nasal Implant for Treatment of …The internal nasal valve, bordered by the...

  • MEDICAL POLICY – 7.01.163

    Absorbable Nasal Implant for Treatment of Nasal Valve

    Collapse

    BCBSA Ref. Policy: 7.01.163

    Effective Date: Jan. 1, 2020

    Last Revised: Dec. 10, 2019

    Replaces: N/A

    RELATED MEDICAL POLICIES:

    None

    Select a hyperlink below to be directed to that section.

    POLICY CRITERIA | CODING | RELATED INFORMATION

    EVIDENCE REVIEW | REFERENCES | HISTORY

    ∞ Clicking this icon returns you to the hyperlinks menu above.

    Introduction

    Cartilage is one of the body’s connective tissues. It’s softer than bone yet strong enough to

    provide structure. Different types of cartilage are inside the nose, including cartilage that makes

    up the side (lateral) walls of the nose. In some cases, taking a breath in through the nose can

    cause the lateral cartilage to flex or collapse, causing a blockage. There are proven ways of

    treating blockages caused by problems with the lateral wall cartilage, including surgery to graft

    cartilage in this area. A newer technique to try to treat breathing problems caused by lateral wall

    collapse calls for implanting a device inside the nose. Over many months, the implant naturally

    dissolves. During the time that it takes for the implant to dissolve, the body naturally forms scar

    tissue where the implant is placed. Scar tissue is more fibrous than regular tissue. It’s thought

    that natural scar tissue can then serve as permanent support for the lateral wall. These types of

    absorbable nasal implants are investigational (unproven). More and longer studies are needed

    to determine if this technique is safe and effective.

    Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The

    rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for

    providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can

    be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a

    service may be covered.

  • Page | 2 of 9 ∞

    Policy Coverage Criteria

    Procedure Investigational Insertion of an absorbable

    lateral nasal implant

    The insertion of an absorbable lateral nasal implant (eg,

    Latera®) for the treatment of symptomatic nasal valve

    collapse is considered investigational.

    Coding

    Code Description

    CPT 30999 Unlisted procedure, nose

    Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS

    codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

    Related Information

    N/A

    Evidence Review

    Description

    Nasal valve collapse 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 nasal valve collapse may be treated with

  • Page | 3 of 9 ∞

    nonsurgical interventions in an attempt to increase the airway capacity but severe symptoms

    and anatomic distortion are treated with surgical cartilage graft procedures. The placement of

    an absorbable implant to support the lateral nasal cartilages has been proposed as an

    alternative to more invasive grafting procedures in patients with severe nasal obstruction. The

    concept is that the implant may provide support to the lateral nasal wall prior to resorption and

    then stiffen the wall with scarring as it is resorbed.

    Background

    Nasal Obstruction

    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 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.

    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 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. The angle at the junction between the septum and upper lateral cartilage is

    normally 10° to 15° in white populations. 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

  • Page | 4 of 9 ∞

    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.1

    Physical Examination

    A thorough physical examination of the nose, nasal cavity, and the 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 one to two 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.

    Treatment

    Treatment of symptomatic nasal valve collapse includes the use of nonsurgical interventions

    such as the adhesive strips applied externally across the nose (applying the principle of the

    Cottle maneuver) 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.

  • Page | 5 of 9 ∞

    Nasal Implants

    The placement of an absorbable implant to support the lateral nasal cartilages has been

    proposed as an alternative to more invasive grafting procedures in patients with severe nasal

    obstruction.

    Summary of Evidence

    For individuals with symptomatic nasal obstruction due to internal nasal valve collapse (NVC)

    who receive an absorbable lateral nasal valve implant, the evidence includes one RCT and two

    nonrandomized prospective, single-cohort studies. The relevant outcomes are symptoms,

    change in disease status, treatment-related morbidity, functional outcomes, and quality of life.

    Overall, improvements in the Nasal Obstruction Symptom Evaluation (NOSE) score have been

    demonstrated in the study reports. Follow-up at three months in the RCT showed a statistically

    significant improvement in response with the implant compared to the sham group, although

    over half of the control group were also considered responders. The duration of outcomes

    reporting is less than the duration of absorption of the device (18 months) and the purported

    completion of the tissue remodeling phase (24 months). It is noted that a follow-up to 24-

    months in this trial is ongoing. Longer follow-up in the prospective cohort studies is available,

    with 24-month follow-up reported in the smaller (n=30) of the cohort studies. However, a

    clinically significant difference may not be consistently apparent in small study populations.

    Some patients meeting the positive responder criteria still reported severe symptoms, and 13%

    of patients required an additional procedure. As reported, adverse events appeared to be mild

    in severity and self-limiting, but still appeared common. At the 12-month follow-up in the larger

    (n=160) cohort, device retrievals occurred in 5% of patients. The need for device retrievals

    appears to occur early in the course of follow-up (one month); suggesting technical experience

    limitations on the part of the operator or inappropriate patient selection. Follow-up to 24-

    months in this cohort is needed. The evidence is insufficient to determine the effects of the

    technology on health outcomes.

    Ongoing and Unpublished Clinical Trials

    A search of ClinicalTrials.gov in September 2019 identified an ongoing trial that might influence

    this review is listed in Table 1.

  • Page | 6 of 9 ∞

    Table 1. Summary of Key Trials

    NCT No. Trial Name Planned

    Enrollment

    Completion

    Date

    Ongoing

    NCT03400787a Latera® Absorbable Nasal Implant vs. Sham Control for

    Lateral Nasal Valve Collapse

    150 Feb 2020

    NCT: national clinical trial.

    aDenotes industry-sponsored or cosponsored trial.

    Practice Guidelines and Position Statements

    American Academy of Otolaryngology - Head Neck Surgery

    The American Academy of Otolaryngology - Head Neck Surgery (2010) released a clinical

    consensus statement on the diagnosis and management of nasal valve compromise.2 Table 2

    summarizes the key consensus statements relevant to this policy. The statement also indicated

    that nasal endoscopy and nasal photography were both deemed useful but not routinely

    required.

    Table 2. Consensus Agreement: Diagnosis and Treatment of NVC

    Item Statement Level of

    Consensus

    Definition NVC is a distinct clinical entity separate from other anatomic reasons

    for nasal obstruction

    Agreement/strong

    agreement

    History and

    physical

    Main symptom of NVC is decreased airflow as reported by the patient Strong agreement

    Anterior rhinoscopy can be adequate for an intranasal evaluation of

    the nasal valve, weak or malformed nasal cartilages

    Agreement/strong

    agreement

    Inspiratory collapse of the lateral nasal wall or alar rim is consistent

    with NVC

    Agreement/strong

    agreement

    Increased nasal obstruction associated with deep inspiration is

    consistent with NVC

    Agreement/strong

    agreement

    Adjunctive

    tests

    Criterion standard test to diagnose NVC exists Strong disagreement

    https://www.clinicaltrials.gov/ct2/show/NCT03400787?term=NCT03400787&rank=1

  • Page | 7 of 9 ∞

    Item Statement Level of

    Consensus

    Outcome

    measures

    Various patient-reported outcomes (eg, visual analog scales,

    satisfaction measures, quality of life scales) are valid indicators of

    successful intervention

    General agreement

    Management Nasal strips, stents, or cones can be used to treat some patients Strong agreement

    A surgical procedure that is intended to support the lateral nasal

    wall/alar rim is a distinct entity from procedures that correct a

    deviated nasal septum or hypertrophied turbinate

    Strong agreement

    NVC: nasal valve compromise.

    Medicare National Coverage

    There is no national coverage determination.

    Regulatory Status

    In May 2016, LATERA® (Spirox) was cleared for marketing by the U.S. Food and Drug

    Administration through the 510(k) process (Food and Drug Administration product code: NHB).2

    LATERA® is the only commercially available absorbable nasal implant for treatment of nasal

    valve collapse. It is a class II device and regulatory details are summarized in Table 3.

    Table 3. Absorbable Nasal Implant Cleared by the Food and Drug

    Administration

    Product Manufacturer Date

    Cleared

    510(k)

    No.

    Indication

    LATERA® absorbable nasal

    implant

    Spirox

    (part of Stryker)

    2016 K161191 Supporting nasal upper

    and lower lateral

    cartilage

  • Page | 8 of 9 ∞

    References

    1. Howard BK, Rohrich RJ. Understanding the nasal airway: principles and practice. Plast Reconstr Surg. Mar 2002;109(3):1128-

    1146; quiz 1145-1146. PMID 11884847

    2. Rhee JS, Weaver EM, Park SS, et al. Clinical consensus statement: Diagnosis and management of nasal valve compromise.

    Otolaryngol Head Neck Surg. Jul 2010;143(1):48-59. PMID 20620619

    3. Fraser L, Kelly G. An evidence-based approach to the management of the adult with nasal obstruction. Clin Otolaryngol. Apr

    2009;34(2):151-155. PMID 19413614

    4. Spirox. Latera. 2017; http://www.spiroxmed.com/latera. Accessed December 2019.

    5. Stewart MG, Witsell DL, Smith TL, et al. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale.

    Otolaryngol Head Neck Surg. Feb 2004;130(2):157-163. PMID 14990910

    6. Lipan MJ, Most SP. Development of a severity classification system for subjective nasal obstruction. JAMA Facial Plast Surg. Sep-

    Oct 2013;15(5):358-361. PMID 23846399

    7. Stolovitzky P, Senior B, Ow RA, et al. Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a

    sham group: a randomized control trial. Int Forum Allergy Rhinol, 2019 Jun 22;9(8). PMID 31226238

    8. Stolovitzky P, Sidle DM, Ow RA, et al. A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency:

    Outcomes using a bioabsorbable implant. Laryngoscope. May 14 2018. PMID 29756407

    9. Sidle DM, Stolovitzky P, Ow RA, et al. Twelve-month outcomes of a bioabsorbable implant for in-office treatment of dynamic

    nasal valve collapse. Laryngoscope, 2019 Jun 30. PMID 31254279

    10. San Nicol M, Stelter K, Sadick H, et al. Absorbable implant to treat nasal valve collapse. Facial Plast Surg. Apr 2017;33(2):233-

    240. PMID 28388804

    11. San Nicoló M, Stelter K, Sadick H, et al. A 2-Year Follow-up Study of an Absorbable Implant to Treat Nasal Valve Collapse. Facial

    Plast Surg, 2018 Sep 19;34(5). PMID 30227454

    History

    Date Comments 04/01/19 New policy, approved March 12, 2019, effective July 4, 2019. Add to Surgery section. A

    literature search was conducted through September 2018. The policy statement is

    investigational. Added CPT 30999.

    01/01/20 Interim Review, approved December 10, 2019. Policy updated with literature review

    through August 2019, references added. Policy statement unchanged.

    Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The

    Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and

    local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review

    http://www.spiroxmed.com/latera

  • Page | 9 of 9 ∞

    and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit

    booklet or contact a member service representative to determine coverage for a specific medical service or supply.

    CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). ©2020 Premera

    All Rights Reserved.

    Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when

    determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to

    the limits and conditions of the member benefit plan. Members and their providers should consult the member

    benefit booklet or contact a customer service representative to determine whether there are any benefit limitations

    applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

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    ជាមានព័ ៌ ៉ ងសំ ់អពី ់ ៉ ប់ តមានយា ខាន ំ ទរមងែបបបទ ឬការរា

    ជូ ត៌ ណឹ នដ

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    LifeWise Health Plan of Washington ។ របែហលជាមាន កាលបរ ិ ឆ ំ ់ េចទសខានេនៅ

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    ក sin costo alguno. Llame al 800-592-6804 (TTY: 800-842-5357). ជ ំ យេចញៃថ កមានសិ េដាយមិ ុ ើ ូ ូ នអសលយេឡយ។ សមទ

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    800-592-6804 (TTY: 800-842-5357)។

    រស័

    ਅੰ

    ਜਾਬੀ (Punjabi): paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon ਇਸ ਨੋ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨੋ ਿਟਸ ਿਵਚ LifeWise Health Plan of tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng LifeWise

    Health Plan of Washington. Maaaring may mga mahalagang petsa dito sa Washington ਵਲ ਤੁ ਜ ਅਤੇ ਅਰਜੀ ਬਾਰੇ ਮਹਤਵਪੂ ੋ ਸਕਦੀ ਹਾਡੀ ਕਵਰੇ ੱ ਰਨ ਜਾਣਕਾਰੀ ਹ

    ពទ

    paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang ਹੈ ੋ ਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹੋ ਂ ਹਨ. ਜੇ ੁ ੇ ੱ ਖਣੀ ਹੋ ੇ mga itinakdang panahon upang mapanatili ang iyong pagsakop sa . ਇਸ ਨ ਸਕਦੀਆ ਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰ ਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱਚ ਮਦਦ ਦੇ ੱ ੁ ੋ ਤਾਂ ਤੁ ੰ ੂ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁ kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ਇਛਕ ਹ ਹਾਨ ੱ ਝ ਖਾਸ

    ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag ਕਦਮ ਚੁਕਣ ਦੀ ਲੜ ਹੋ ਸਕਦੀ ਹ ੈ,ਤੁ ੰ ੂ ਮੁ ੱ ਚ ਤੇ ੱ ਚ ਜਾਣਕਾਰੀ ਅਤੇ ੱ ੋ ਹਾਨ ਫ਼ਤ ਿਵ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ਮਦਦ sa 800-592-6804 (TTY: 800-842-5357). ਪ੍ਰ ੈਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ,ਕਾਲ 800-592-6804 (TTY: 800-842-5357).

    ਪੰ

    Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang

    ไทย (Thai): ประกาศน ้ีมีข้อมลูสําคญั ประกาศน ้ีอาจมีข้อมลูที่สําคญัเกี่ยวกบัการการสมคัรหรือขอบเขตประกนั

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    สขุภาพของคณุผ่าน LifeWise Health Plan of Washington และอาจมีกําหนดการในประกาศ طريق از ماش ای مهبي وششپ يا و تقاضا LifeWise Health Plan of Washington به .باشدี น جهتو يهمالعا اين در ھمم ھای خيتار يا تان بيمه وششپ حقظ برای است کنمم ماش . يدماين کمک คณุอาจจะต้องดําเนินการภายในกําหนดระยะเวลาที่แน่นอนเพื่อจะรักษาการประกนัสขุภาพของคณุ

    اجتياح صیاخ کارھای امانج برای صیمشخ ھای خيتار به تان، انیمدر ھای زينهھ پرداخت درหรือการช่วยเหลือที่มีค่าใช้จ่าย คณุมีสิทธิที่จะได้รับข้อมลูและความช่วยเหลือน ้ีในภาษาของคณุโดยไม่ม ีباشيد داشته . رايگان ورط به ودخ انزب به را مکک و اطالعات اين که داريد را اين حق ماش

    (ค่าใช้จ่าย โทร 800-592-6804 (TTY: 800-842-5357 مارهش با اطالعات سبک برای . نماييد دريافت 800-592-6804 . اييد نم برقرار استم ) 5357-842-800 مارهباش اس تم TTY کاربران(

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