MEDICAL POLICY – 7.01.128

Bronchial Valves

BCBSA Ref. Policy: 7.01.128

Effective Date: Sept. 1, 2019

Last Revised: Aug. 6, 2019

Replaces: N/A

RELATED MEDICAL POLICIES:

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POLICY CRITERIA | CODING | RELATED INFORMATION

EVIDENCE REVIEW | REFERENCES | HISTORY

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Introduction

In the chest, the lung sits in an airless sack called the pleural cavity or pleural space. The only air

in the chest should be found within the lung itself. If the lung leaks air, the air can escape from

the lung into the pleural space. If air leaks into the pleural space, the lung may be unable to

adequately inflate, resulting in a collapsed lung or shallow, slow, or inadequate breathing. As a

result, too little oxygen may get into the blood. Air leaks can occur because of disease, surgery,

or injury. A type of one-way valve has been proposed as a way to try to keep air from leaking

out of the lung. The umbrella-shaped device is placed in the airway and is intended to keep air

from moving toward the air leak. This type of device is investigational (unproven). More studies

are needed to see how well it works compared to standard treatments and to look at its overall

safety.

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.

Policy Coverage Criteria

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Device Investigational Bronchial valves Bronchial valves are considered investigational in all situations

including but not limited to:

• Treatment of prolonged air leaks

• Treatment for patients with chronic obstructive pulmonary

disease or emphysema

Coding

Code Description

CPT 31647 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with

balloon occlusion, when performed, assessment of air leak, airway sizing, and insertion

of bronchial valve(s), initial lobe

31648 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with

removal of bronchial valve(s), initial lobe

31649 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with

removal of bronchial valve(s), each additional lobe (List separately in addition to code

for primary procedure)

31651 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with

balloon occlusion, when performed, assessment of air leak, airway sizing, and insertion

of bronchial valve(s), each additional lobe (List separately in addition to code for

primary procedure[s])

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

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Description

Bronchial valves are synthetic devices deployed with bronchoscopy into ventilatory airways of

the lung to control airflow. They have been investigated for use in patients who have prolonged

bronchopleural air leaks and as an alternative to lung volume reduction surgery in patients with

lobar hyperinflation from severe or advanced emphysema.

Background

Air Leaks

Proper lung functioning depends on the separation between the air-containing parts of the lung

and the small vacuum-containing space around the lung called the pleural space. When air leaks

into the pleural space the lung is unable to inflate, resulting in hypoventilation and hypoxemia;

this condition is known as a pneumothorax. A pneumothorax can result from trauma, high

airway pressures induced during mechanical ventilation, lung surgery, and rupture of lung blebs

or bullae, which may be congenital or the result of chronic obstructive pulmonary disease.

Treatment

Although an air leak from the lung into the pleural space may seal spontaneously, it often

requires intervention. Techniques currently used to try to close air leaks include the following:

• Inserting a chest tube (tube thoracostomy) and using a water seal or one-way valve to

evacuate air collected in the pleural space and prevent it from reaccumulating;

• Lowering airway pressures by adjusting the mechanical ventilator;

• Using autologous blood patches; and

• Performing a thoracotomy with mechanical or chemical pleurodesis.

A bronchial valve is a device that permits one-way air movement. During inhalation the valve is

closed, preventing air flow to the diseased area of the lung. The valve opens during exhalation

to allow air to escape from the diseased area of the lung. When used to treat persistent air leak

from the lung into the pleural space, the bronchial valve theoretically permits less air flow across

the diseased portion of the lung during inhalation, aiding in air leak closure. The valve may be

placed, and subsequently removed, by bronchoscopy.

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Emphysema

In emphysematous chronic obstructive pulmonary disease, peripheral lung tissue may form

bullae. These diseased portions of the lung ventilate poorly, cause air trapping, and

hyperinflation, compressing relatively normal lung tissue. They also may rupture, causing a

pneumothorax.

Treatment

Use of a bronchial valve is thought to prevent hyperinflation of bullae. Their use to treat chronic

obstructive pulmonary disease is based on the improvement observed in patients who have

undergone lung volume reduction surgery. Lung volume reduction surgery involves excision of

peripheral emphysematous lung tissue, generally from the upper lobes. The precise mechanism

of clinical improvement for patients undergoing lung volume reduction has not been firmly

established. However, it is believed that elastic recoil and diaphragmatic function are improved

by reducing the volume of the diseased lung. The procedure is designed to relieve dyspnea and

improve functional lung capacity and quality of life; it is not curative. Bronchial valves have been

investigated as a nonsurgical alternative to lung volume reduction surgery.

Summary of Evidence

For individuals who have pulmonary air leaks who receive bronchial valves, the evidence

includes case series and a prospective cohort observational study related to the Humanitarian

Device Exemption for the Spiration IBV Valve device. Relevant outcomes are overall survival,

symptoms, functional outcomes, quality of life, and treatment-related morbidity. Other reports

are small series of heterogeneous patients. There are no comparative data with alternatives. The

evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have severe or advanced emphysema who receive bronchial valves, the

evidence includes11 RCTs and 3 systemic reviews. Relevant outcomes are overall survival,

symptoms, functional outcomes, quality of life, and treatment-related morbidity. In patients with

severe emphysema and low collateral ventilation, RCTs provide evidence of clinically meaningful

benefit for bronchial valves compared to standard medical management on measures of lung

function, exercise tolerance, and quality of life, but there was a greater risk of serious adverse

events compared to usual care. Because of limitations in study designs, especially a lack of

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blinding, significant heterogeneity across studies on some measures, and a higher risk of serious

adverse events, with up to 29% of patients experiencing pneumothorax, the evidence is

insufficient to determine that the technology improves the net health outcome.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No. Trial Name Planned

Enrollment

Completion

Date

Ongoing

NCT02382614a Safety and Effectiveness of the Spiration Valve System

(SVS) in Air Leaks (VAST)

200 Dec 2018

(suspended)

NCT02022683a A Multi-center, Prospective, Randomized, Controlled Trial

of Endobronchial Valve Therapy vs. Standard of Care in

Heterogeneous Emphysema (TRANSFORM)

97 Dec 2018

(long-term

safety)

NCT01796392a Lung Function Improvement After Bronchoscopic Lung

Volume Reduction With Pulmonx Endobronchial Valves

Used in Treatment of Emphysema (LIBERATE)

183 Sep 2021

(long-term

safety)

NCT01812447a A Prospective, Randomized, Controlled Multicenter Clinical

Study to Evaluate the Safety and Effectiveness of the

Spiration® Valve System for the Single Lobe Treatment of

Severe Emphysema (EMPROVE)

172 May 2022

NCT: national clinical trial.

a Denotes industry-sponsored or cosponsored trial.

Clinical Input Received from Physician Specialty Societies and Academic

Medical Centers

While the various physician specialty societies and academic medical centers may collaborate

with and make recommendations during this process, through the provision of appropriate

reviewers, input received does not represent an endorsement or position statement by the

physician specialty societies or academic medical centers, unless otherwise noted.

https://www.clinicaltrials.gov/ct2/show/NCT02382614?term=NCT02382614&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02022683?term=NCT02022683&rank=1https://www.clinicaltrials.gov/ct2/show/NCT01796392?term=NCT01796392&rank=1https://www.clinicaltrials.gov/ct2/show/NCT01812447?term=NCT01812447&rank=1

Page | 6 of 10 ∞

In response to requests, input was received through one physician specialty society and three

academic medical centers while this policy was under review in 2011. Input generally agreed that

use of bronchial valves is investigational for treating emphysema. Regarding use of bronchial

valves for treating prolonged air leaks, reviewers acknowledged that only limited case series are

available. Of the four reviewers, one supported the investigational indication, two supported the

compassionate use of valves for treating prolonged air leaks, and the fourth thought that

treatment of prolonged air leaks might be reasonable but had concerns about potential

complications.

Practice Guidelines and Position Statements

British Thoracic Society

In 2011, the British Thoracic Society published guidelines on advanced diagnostic and

therapeutic flexible bronchoscopy in adults.15 The guidelines indicated that the evidence is

insufficient to recommend routine use of bronchial valves for treatment of emphysema.

National Institute for Health and Care Excellence (NICE)

In December 2017, NICE issued the following recommendations on endobronchial valve

insertion to reduce lung volume in emphysema:16

1.1 Current evidence on the safety and efficacy of endobronchial valve insertion to reduce

lung volume in emphysema is adequate in quantity and quality to support the use of this

procedure provided that standard arrangements are in place for clinical governance, consent

and audit.

1.2 Patient selection should be done by a multidisciplinary team experienced in managing

emphysema, which should typically include a chest physician, a radiologist, a thoracic surgeon

and a respiratory nurse.

1.3 Patients selected for treatment should have had pulmonary rehabilitation.

1.4 The procedure should only be done to occlude volumes of the lung where there is no

collateral ventilation, by clinicians with specific training in doing the procedure.

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Medicare National Coverage

There is no national coverage determination.

Regulatory Status

In October 2008, the Spiration® IBV System (Spiration) was approved by the U.S. Food and Drug

Administration (FDA) through the humanitarian device exemption (H060002) process for use in

controlling prolonged air leaks of the lung or significant air leaks that are likely to become

prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery. An

air leak present on postoperative day 7 is considered prolonged unless present only during

forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it

is: (1) continuous, (2) present during the normal inhalation phase of inspiration, or (3) present on

normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.

Use of the intrabronchial Valve System is limited to 6 weeks per prolonged air leak. FDA product

code: OAZ.

Currently, two bronchial valve systems are FDA approved for treatment of patients with severe

emphysema. In June 2018, FDA granted the Zephyr Valve system breakthrough device status

with expedited approval for the bronchoscopic treatment of adult patients with hyperinflation

associated with severe emphysema in regions of the lung that have little to no collateral

ventilation. In December 2018, FDA approved the Spiration Valve System for adult patients with

shortness of breath and hyperinflation associated with severe emphysema in regions of the lung

that have evidence of low collateral ventilation. FDA product code: NJK.

Table 2. Bronchial Valves Approved by FDA

Device Manufacturer Location Date

Approved

HDE/PMA

No.

IBV® Valve System

To control prolonged air leaks of the

lung, or significant air leaks that are likely

to become prolonged air leaks, following

lobectomy, segmentectomy, or lung

volume reduction surgery (LVRS).

Spiration, Inc Redmond, WA 10/24/08 H060002

Spiration® Valve System Spiration, Inc Redmond, WA 12/03/18 P180007

Page | 8 of 10 ∞

Device Manufacturer Location Date

Approved

HDE/PMA

No.

One-way endobronchial valves indicated

for adult patients with shortness of

breath and hyperinflation associated with

severe emphysema in regions of the lung

that have evidence of low collateral

ventilation

Breakthrough designation status

06/18/15

Zephyr® Endobronchial Valve System

Implantable bronchial valves indicated

for the bronchoscopic treatment of adult

patients with hyperinflation associated

with severe emphysema in regions of the

lung that have little to no collateral

ventilation

Breakthrough designation status

Pulmonx

Corporation

Redwood City,

CA

06/29/18

05/04/17

P180002

FDA: Food and Drug Administration, HDE: human device exemption; PMA: premarket approval application.

References

1. Travaline JM, McKenna RJ, Jr., De Giacomo T, et al. Treatment of persistent pulmonary air leaks using endobronchial valves.

Chest. Aug 2009;136(2):355-360. PMID 19349382.

2. Firlinger I, Stubenberger E, Muller MR, et al. Endoscopic one-way valve implantation in patients with prolonged air leak and the

use of digital air leak monitoring. Ann Thorac Surg. Apr 2013;95(4):1243-1249. PMID 23434254.

3. Gillespie CT, Sterman DH, Cerfolio RJ, et al. Endobronchial valve treatment for prolonged air leaks of the lung: a case series. Ann

Thorac Surg. Jan 2011;91(1):270-273. PMID 21172529.

4. van Agteren JE, Hnin K, Grosser D, et al. Bronchoscopic lung volume reduction procedures for chronic obstructive pulmonary

disease. Cochrane Database Syst Rev. Feb 23 2017;2:CD012158. PMID 28230230.

5. National Institute for Health and Care Excellence. Chronic obstructive pulmonary disease in over 16s: Diagnosis and

management. Available at: https://www.nice.org.uk/guidance/ng115 Accessed August 2019.

6. van Geffen, WW, Slebos, DD, Herth, FF, Kemp, SS, Weder, WW, Shah, PP. Surgical and endoscopic interventions that reduce

lung volume for emphysema: a systemic review and meta-analysis. Lancet Respir Med, 2019 Feb 13;7(4). PMID 30744937.

7. Criner, GG, Sue, RR, Wright, SS, Dransfield, MM, Rivas-Perez, HH, Wiese, TT, Sciurba, FF, Shah, PP, Wahidi, MM, de Oliveira, HH,

Morrissey, BB, Cardoso, PP, Hays, SS, Majid, AA, Pastis, NN, Kopas, LL, Vollenweider, MM, McFadden, PP, Machuzak, MM, Hsia,

DD, Sung, AA, Jarad, NN, Kornaszewska, MM, Hazelrigg, SS, Krishna, GG, Armstrong, BB, Shargill, NN, Slebos, DD, Criner, GG,

Cordova, FF, Desai, PP, Marchetti, NN, Kim, VV, Shenoy, KK, Travaline, JJ, Thomas, JJ, Criner, LL, Sue, RR, Wright, SS, Thornburg,

AA, Thomas, TT, Dransfield, MM, Bhatt, SS, Wells, JJ, Seabron-Harris, NN, Rivas-Perez, HH, Gauhar, UU, Wiese, TT, Despirito, CC,

Sciurba, FF, Bon Field, JJ, Chandra, DD, Leader, JJ, Semaan, RR, Ledezma, CC, Shah, PP, Kemp, SS, Garner, JJ, Aboelhassan, AA,

https://www.nice.org.uk/guidance/ng115

Page | 9 of 10 ∞

Srikanthan, KK, Tenda, EE, Abraham, AA, Sim, CC, Wahidi, MM, Mahmood, KK, Shofer, SS, Coles, KK, de Oliveira, HH, Oliveira,

GG, Machado, BB, Benedetto, II, Svartman, FF, de Macedo Neto, AA, Schreiner, LL, Vieira, TT, Morrissey, BB, Yoneda, KK, Tham,

TT, Tompkins, DD, Guerreiro Cardoso, PP, Athanazio, RR, Nominando, FF, Rached, SS, Cassimiro, LL, Hays, SS, Seeley, EE,

Shrestha, PP, Dincheva, GG, Majid, AA, Alape-Moya, DD, Parikh, MM, Paton, AA, Agnew, AA, Pastis, NN, Strange, CC, Beiko, TT,

Woodford, DD, Blanton, MM, Kopas, LL, Connolly, TT, Santacruz, JJ, Shah, BB, Vollenweider, MM, Herrera, LL, Khan, RR, Sernulka,

KK, McFadden, PP, Barbers, RR, Hernandez, MM, Machuzak, MM, Almeida, FF, Cicenia, JJ, Gildea, TT, Mehta, AA, Sethi, SS, Meli,

YY, Hsia, DD, Casaburi, RR, Stringer, WW, Diaz, LL, Sung, AA, Ramsey, MM, Van Wert, RR, Morris, KK, Jarad, NN, Batchelor, TT,

Sequeiros, II, Tucker, KK, Kornaszweska, MM, Fallouh, HH, Sabit, RR, Naase, HH, George, JJ, Salimian, AA, Dyer, HH, Hazelrigg,

SS, Adams, KK, Bade, KK, Krishna, GG, Benn, BB, Canfield, MM, Vetri Villalan, SS, Stewart, TT, Slebos, DD, Ten Hacken, NN,

Klooster, KK, Hartman, JJ, Augustijn, SS. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in

Heterogeneous Emphysema (LIBERATE). Am. J. Respir. Crit. Care Med., 2018 May 23;198(9). PMID 29787288.

8. Kemp, SS, Slebos, DD, Kirk, AA, Kornaszewska, MM, Carron, KK, Ek, LL, Broman, GG, Hillerdal, GG, Mal, HH, Pison, CC, Briault, AA,

Downer, NN, Darwiche, KK, Rao, JJ, Hübner, RR, Ruwwe-Glosenkamp, CC, Trosini-Desert, VV, Eberhardt, RR, Herth, FF, Derom,

EE, Malfait, TT, Shah, PP, Garner, JJ, Ten Hacken, NN, Fallouh, HH, Leroy, SS, Marquette, CC. A Multicenter Randomized

Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). Am. J. Respir. Crit.

Care Med., 2017 Sep 9;196(12). PMID 28885054.

9. Herth FJ, Noppen M, Valipour A, et al. Efficacy predictors of lung volume reduction with Zephyr valves in a European cohort. Eur

Respir J. Jun 2012;39(6):1334-1342. PMID 22282552.

10. Davey C, Zoumot Z, Jordan S, et al. Bronchoscopic lung volume reduction with endobronchial valves for patients with

heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial. Lancet. Sep

12 2015;386(9998):1066-1073. PMID 26116485.

11. Sciurba FC, Ernst A, Herth FJ, et al. A randomized study of endobronchial valves for advanced emphysema. N Engl J Med. Sep 23

2010;363(13):1233-1244. PMID 20860505.

12. Wood DE, Nader DA, Springmeyer SC, et al. The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial

therapy for severe emphysema. J Bronchology Interv Pulmonol. Oct 2014;21(4):288-297. PMID 25321447.

13. Li, SS, Wang, GG, Wang, CC, Gao, XX, Jin, FF, Yang, HH, Han, BB, Zhou, RR, Chen, CC, Chen, LL, Bai, CC, Shen, HH, Herth, FF,

Zhong, NN. The REACH Trial: A Randomized Controlled Trial Assessing the Safety and Effectiveness of the Spiration® Valve

System in the Treatment of Severe Emphysema. Respiration, 2018 Dec 17;1-12:1-12. PMID 30554211.

14. U.S. Food & Drug Administration. Spiration Valve System. Summary of Safety and Effectiveness Data. Available at:

https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180007B.pdf Accessed August 2019.

15. Du Rand IA, Barber PV, Goldring J, et al. Summary of the British Thoracic Society guidelines for advanced diagnostic and

therapeutic flexible bronchoscopy in adults. Thorax. Nov 2011;66(11):1014-1015. PMID 22003155.

16. National Institute for Health and Care Excellence. Endobronchial valve insertion to reduce lung volume in emphysema. Available

at: https://www.nice.org.uk/guidance/IPG600/chapter/1-Recommendations Accessed August 2019.

History

Date Comments 01/11/11 Add to Surgery Section - New policy created with literature search through October

2010; considered investigational.

04/25/12 Replace policy. Policy updated with clinical input and a literature search through

December 2011. References 10, 12 and 13 added; other references reordered. Policy

https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180007B.pdfhttps://www.nice.org.uk/guidance/IPG600/chapter/1-Recommendations

Page | 10 of 10 ∞

Date Comments statements unchanged.

01/10/13 Coding update. CPT codes 0250T – 0252T deleted as of 12/31/12; these are replaced

by 31647 – 31649, which are added to the policy, along with 31651, 31660 – 31661, all

effective 1/1/13.

04/16/13 Replace policy. Policy updated with a literature search through January 16, 2013.

Reference 6 added; other references reordered. Policy statements unchanged. Codes

31660 and 31661 removed; they have been added to another policy and do not apply

to this policy.

05/05/14 Annual Review. Policy updated with a literature search through January 7, 2014.

References 2 and 8 added; other references reordered or removed. Policy statements

unchanged.

05/27/15 Annual Review. Policy updated with a literature review through February 4, 2015.

References 8-9 added. Policy statement edited for clarification only. ICD-10-PCS codes

added per remediation.

09/01/16 Annual Review, approved August 9, 2016. Policy updated with literature review

through April 27, 2016; reference 8 added. Policy statement unchanged.

08/01/17 Annual Review, approved July 25, 2017. Policy moved to new format. Policy updated

with literature review through April 25, 2017; reference 4 added. “Endobronchial”

changed to “Bronchial” in policy and title. Policy statement otherwise unchanged.

09/01/18 Annual Review, approved August 23, 2018. Policy updated with literature review

through April 2018; no references added. Policy statement unchanged.

09/01/19 Annual Review, approved Aug. 6, 2019. Policy updated with literature review through

April 2019; references added. Regulatory status section updated with indications for

patients with severe emphysema. Policy statement unchanged.

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Arabic

Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu danda’a. Guyyaawwan murteessaa ta’an beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu danda’a. Kaffaltii irraa bilisa haala ta’een afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu. Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa.

Français (French): Cet avis a d'importantes informations. Cet avis peut avoir d'importantes informations sur votre demande ou la couverture par l'intermédiaire de Premera Blue Cross. Le présent avis peut contenir des dates clés. Vous devrez peut-être prendre des mesures par certains délais pour maintenir votre couverture de santé ou d'aide avec les coûts. Vous avez le droit d'obtenir cette information et de l’aide dans votre langue à aucun coût. Appelez le 800-722-1471 (TTY: 800-842-5357).

Kreyòl ayisyen (Creole): Avi sila a gen Enfòmasyon Enpòtan ladann. Avi sila a kapab genyen enfòmasyon enpòtan konsènan aplikasyon w lan oswa konsènan kouvèti asirans lan atravè Premera Blue Cross. Kapab genyen dat ki enpòtan nan avi sila a. Ou ka gen pou pran kèk aksyon avan sèten dat limit pou ka kenbe kouvèti asirans sante w la oswa pou yo ka ede w avèk depans yo. Se dwa w pou resevwa enfòmasyon sa a ak asistans nan lang ou pale a, san ou pa gen pou peye pou sa. Rele nan 800-722-1471 (TTY: 800-842-5357).

Deutsche (German): Diese Benachrichtigung enthält wichtige Informationen. Diese Benachrichtigung enthält unter Umständen wichtige Informationen bezüglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung. Sie könnten bis zu bestimmten Stichtagen handeln müssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471 (TTY: 800-842-5357).

Hmoob (Hmong): Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471 (TTY: 800-842-5357).

Iloko (Ilocano): Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357).

Italiano ( ):Questo avviso contiene informazioni importanti. Questo avviso può contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. Chiama 800-722-1471 (TTY: 800-842-5357).

Italian

中文 (Chinese):本通知有重要的訊息。本通知可能有關於您透過 Premera Blue Cross 提交的申請或保險的重要訊息。本通知內可能有重要日期。您可能需要在截止日期

之前採取行動，以保留您的健康保險或者費用補貼。您有權利免費以您的母

語得到本訊息和幫助。請撥電話 800-722-1471 (TTY: 800-842-5357)。

037338 (07-2016)

https://www.hhs.gov/ocr/office/file/index.htmlhttps://ocrportal.hhs.gov/ocr/portal/lobby.jsfmailto:AppealsDepartmentInquiries@Premera.com

日本語 (Japanese):この通知には重要な情報が含まれています。この通知には、 Premera Blue Crossの申請または補償範囲に関する重要な情報が含まれている場合があります。この通知に記載されている可能性がある重要な日付をご確認くだ

さい。健康保険や有料サポートを維持するには、特定の期日までに行動を

取らなければならない場合があります。ご希望の言語による情報とサポー

トが無料で提供されます。800-722-1471 (TTY: 800-842-5357)までお電話ください。

한국어 (Korean): 본 통지서에는 중요한 정보가 들어 있습니다 . 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross 를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 . 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다. 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 . 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 . 800-722-1471 (TTY: 800-842-5357) 로 전화하십시오 .

ລາວ (Lao): ແຈ້ງການນີ້ ນສໍ າຄັນ. ແຈ້ງການນີ້ອາດຈະມີ ນສໍ າຄັນກ່ຽວກັບຄໍ າຮ້ອງສະ ກ ຫຼື ຄວາມຄຸ້ມຄອງປະກັນໄພຂອງທ່ານຜ່ານ Premera Blue Cross. ອາດຈະມີ ນທີ າຄັນໃນແຈ້ງການນີ້. ທ່ານອາດຈະຈໍ າເປັ ນຕ້ອງດໍ າເນີ ນການຕາມກໍ ານົດ ເວລາສະເພາະເພື່ອຮັກສາຄວາມຄຸ້ມຄອງປະກັນສຸຂະພາບ ຫຼື ຄວາມຊ່ວຍເຫຼື ອເລື່ອງ າໃຊ້ າຍຂອງທ່ານໄວ້ . ທ່ານມີ ດໄດ້ ບຂໍ້ ນນີ້ ແລະ ຄວາມຊ່ວຍເຫຼື ອເປັ ນພາສາ ຂອງທ່ານໂດຍບ່ໍ ເສຍຄ່າ. ໃຫ້ໂທຫາ 800-722-1471 (TTY: 800-842-5357).

ູຂໍ້

່

ສໍ ັ

ຈ

ໝ

ສິ

ັ

່

ວ

ຄ

ມ

ມູຮັ

ູມີ ມຂໍ້

ភាសាែខមរ ( ): ឹ

រងរបស់

Premera Blue Cross ។ របែហលជាមាន កាលបរ ិ ឆ ំខានេនៅកងេសចក

េសចកតជី ូ

ជាមានព័ ៌ ៉ ងសំ ់អពី ់ ៉ ប់

នដំ ងេនះមានព័ ី

តមានយា ខាន ំ ទរមងែបបបទ ឬការរា

ណ ត៌មានយ៉ា ំ ់ តងសខាន។ េសចក

េចទស ់ ន ុ ត

ណងេនះ។ អ វការបេញញសមតភាព ដលកណតៃថ ចបាស

កតាមរយៈ

ដំ ឹ នករបែហលជារតូ ច ថ ់ ំ ់ ងជាក់ ់

នដ

ន

ី ន

ូ

អ

ូ

ជ

ជ

ំណឹងេនះរបែហល

នានា េដើ ីនងរកសាទុ ៉ បរងស់ ុ ់ ក ឬរបាក់ ំ

អ

មប ឹ កការធានារា ខភាពរបស ជ

ធនកមានសិ ទទលព័ មានេនះ និ ំ យេនៅកុងភាសារបសទិ ួ ត៌ ងជ ននួ

ន

់ កេដាយម

អ

នអ

យេចញៃថល។ ួ

នអស

ន

ិ

លុ ើ ូ ូយេឡយ។ សមទ ទ រស័ព 800-722-1471 (TTY: 800-842-5357)។

Khmer

ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹ ਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ . ਇਸ ਨ ਿਜਸ ਜਵਚ ਖਾਸ

ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ. ਜੇਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ੇਇਛ ੁਕ ਹ ਤਾਂ ਤਹਾਨ ਅ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ,ਤਹੁਾਨ ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ,ਕਾਲ 800-722-1471 (TTY: 800-842-5357).

ਪ ਜਾਬੀ (Punjabi): ਇਸ ਨ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ. ਇਸ ਨ ਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤੁਹਾਡੀ

ੰ

ੰ

ੇ ੇ ੇ ੱ ੂ ੋ ੈ ੋੋ ਂ ੁ ੇ ੱ ੋ ੇ ੱੱ ੁ ੱ ੂੁ ੱ ੇ ੱ ੇ ੍ਰ ੈ

ੋ ੰ ੂ ੱ ੁ ੋ ੋ ੈ ੰ

ੋ ੈ ੋ

(Farsi): فارسی فرم بارهدر ھمم اطالعات حاوی است ممکن يهمالعا اين. ميباشد ھمم اطالعات یوحا يهمالعا اين

در ھمم ھای خيتار به باشد.پ رایبستاکنممماش زينهھ اختدپر در مککيا تان بيمهوشش حقظ

Premera Blue Cross طريق از ماش مهبيوشش يا و تقاضا ای پ. يدماين جهتو يهمالعا اين

حق شما. يدشاب داشته اجتياح صیاخ کارھای امانج برای صیمشخ ایھ خيتار به تان، انیمدر ھای کسب برای .نماييد دريافت گانيرا ورط به ودخ زبان به را کمک و اطالعات اين که داريد را اين

استم ) 5357-842-800 مارهباش ماست TTY انکاربر(800-722-1471 مارهش با اطالعات .اييدنم برقرار

้

Polskie (Polish): To ogłoszenie może zawierać ważne informacje. To ogłoszenie może

zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej informacji we własnym języku. Zadzwońcie pod 800-722-1471 (TTY: 800-842-5357).

Português (Portuguese): Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio do Premera Blue Cross. Poderão existir datas importantes neste aviso. Talvez seja necessário que você tome providências dentro de determinados prazos para manter sua cobertura de saúde ou ajuda de custos. Você tem o direito de obter e sta informação e ajuda em seu idioma e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).

Română (Romanian): Prezenta notificare conține informații importante. Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie în această notificare. Este posibil să fie nevoie să acționați până la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471 (TTY: 800-842-5357).

Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross. В настоящем уведомлении могут быть указаны ключевые даты. Вам, возможно, потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами. Вы имеете право на бесплатное получение этой информации и помощь на вашем языке. Звоните по телефону 800-722-1471 (TTY: 800-842-5357).

Fa’asamoa (Samoan): Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357).

Español ( ): Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de Premera Blue Cross. Es posible que haya fechas clave en este

tiene derecho a recibir esta información y ayuda en su idioma sin costo

aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura médica o ayuda con los costos. Usted

alguno. Llame al 800-722-1471 (TTY: 800-842-5357).

Spanish

Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357).

ไทย (Thai): ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกน สขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตอง ดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอท มคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไม่มคาใชจาย โทร 800-722-1471 (TTY: 800-842-5357)

้ี ี ้ ู ํ ั ้ี ี ้ ู ่ี ํ ั ่ี ั ั ื ัุ ุ ่ ี ํ ี ุ ้ํ ิ ํ ่ี ่ ่ื ั ั ุ ุ ื ่ ื ่ีี ่ ้ ่ ุ ี ิ ิ ่ี ้ ั ้ ู ่ ื ้ี ุ ี ่ ้ ่

Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за номером телефону 800-722-1471 (TTY: 800-842-5357).

Tiếng Việt (Vietnamese): Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).