MEDICAL POLICY – 7.01.161 Three-Dimensional Printed Orthopedic Implants BCBSA Ref. Policy: 7.01.161 Effective Date: Oct. 1, 2020 Last Revised: Sept. 1, 2020 Replaces: N/A

RELATED MEDICAL POLICIES: 7.01.144 Patient-Specific Cutting Guides and Custom Knee Implants

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POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY

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Introduction

An orthopedic implant is a device that fixes a bone or joint problem. The implant can replace a joint or reinforce or support a damaged bone. There are a wide variety of implants that come in many shapes and sizes. Typically, medical imaging is used to look at the damaged area to determine the shape and size of the implant. Standard implants can often be used to address a patient’s particular problem. In some cases, however, a standard implant can’t be made to fit the area due to unusual anatomy or bone shape. In these cases, a 3-dimensional (3D) custom implant may be created. The implants rely on a technique known as 3D printing, which adds material one very thin layer at a time. These custom implants are truly custom. The shape can’t be made over and over again and marketed to other patients who need similar implants. This policy describes when a 3D custom implant may be covered.

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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Implant Medical Necessity Custom Three-dimensional (3D) printed implants

Custom 3D printed implants for patients with bone or joint deformity may be considered medically necessary when: • The devices are produced at a central manufacturing facility

(eg, not at the point-of-care) AND • The devices meet FDA custom device exemption requirements

(see Regulatory Status)

Implant Investigational Three-dimensional (3D) printed orthopedic implants

Three-dimensional (3D) printed orthopedic implants that have a design that is approved or cleared by the U.S. Food and Drug Administration (FDA) and produced in standard sizes for patients with typical bone and joint anatomy are investigational.

Patient-matched 3D printed implants

Patient-matched 3D printed implants that are based on non-standard shapes and sizes for patients with typical bone and joint anatomy and do not qualify as custom devices according to FDA custom device exemption requirements are investigational.

3D printed orthopedic implants, non-FDA

Three-dimensional printed orthopedic implants produced outside of FDA-regulated manufacturing facilities are investigational.

Note: This policy does not address custom mandible or maxillofacial implants.

Documentation Requirements The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include the following: • For Custom 3D printed implants for patients with bone or joint deformity:

o Documentation that the devices are produced at a central manufacturing facility (eg, not at the point-of-care)

o Documentation that the device meets FDA custom device exemption requirements

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Coding

Code Description HCPCS L8699 Prosthetic implant, not otherwise specified.

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

This policy addresses orthopedic implants that are constructed by additive manufacturing, commonly known as 3-dimensional (3D) printing. Three situations are considered: 3D printing of standard-sized implants, 3D printing of patient-matched implants for individuals who have typical bone and joint anatomy, and custom 3D printed implants for patients who have bone or joint deformity.

Background

Three-dimensional (3D) printed implants are made by a process of additive manufacturing. Additive manufacturing uses a computer-aided process with a 3D printer to build devices one layer at a time. The most commonly used technologies in medical devices are powder bed fusion, stereolithography, fused filament fabrication, and liquid-based extrusion.1 Stereolithography systems use a vat of liquid that is cured by light. Fused filament fabrication melts a solid filament at the point of deposition, after which it solidifies, while liquid-based

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extrusion systems eject a liquid which then solidifies. Orthopedic implants are frequently made with cobalt-chromium or titanium powder bed fusion, which uses an energy source such as laser or electron beam to melt or sinter a layer of metal powder onto the layer below.

Additive manufacturing contrasts with the traditional methods of manufacturing, which include forging (shaped by hammering or bending), casting (formed by molten metal poured into a mold), and machining (removes material to create the desired geometry). Traditional manufacturing methods are frequently used with cobalt-chromium alloys for orthopedic implants. Titanium is also used for implants, including the femoral stems and acetabular cups used for total hip arthroplasty. The manufacturing of titanium and titanium alloys with traditional production methods is more difficult. Production of complex shapes is also limited with forging, casting, or machining.

Advantages of additive manufacturing include the ability to manufacture complex structures that traditional manufacturing processes cannot, and to create devices individually matched to the patient’s anatomy. Additive manufacturing also allows rough or porous surface textures that promote bone in-growth, and some have proposed that fully porous implants may reduce bone resorption around the implant. Three-dimensional printed models of a joint or spine can also be constructed to plan and practice complex surgeries. In addition to increased design flexibility and potential improvements in function, additive manufacturing wastes less raw materials and may reduce processing costs.

Additive manufacturing may, however, introduce variability into the manufacturing process. A number of factors affect the production of patient-matched orthopedic implants. One factor is whether the device is based on a standard template or custom-designed. Another is if the design could be affected by image quality, rigidity of anatomic structures, or clarity of anatomic landmarks. Some patient-matched devices are based on a standard-sized template with specific features modified within a defined design or performance envelope. Patient-matched devices that follow the patient anatomy more precisely are more vulnerable to design errors.

Manufacturing processes that occur after printing can also affect device performance and material properties. Postprocessing may include removal of manufacturing residues, heat treatments, and final machining and polishing when needed and where surfaces are accessible. For devices made with additive manufacturing, the U.S. Food and Drug Administration (FDA) recommends process validation, revalidation if there are any changes to the device or process, and mechanical device testing in a manner similar to testing of devices made with a traditional manufacturing method. Three-dimensional printing of orthopedic implants at a central facility permits the manufacturer to regulate quality, biocompatibility of materials, and sterility.

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Summary of Evidence

For individuals who have typical bone and joint anatomy and are undergoing standard orthopedic procedures who receive a standard-sized 3D printed implant, the evidence includes an RCT and systematic review. The relevant outcomes include symptoms, functional outcomes, and quality of life. There is limited data on the performance of orthopedic implants produced by additive manufacturing. 3D-printed implants are often manufactured with titanium and permit greater porosity than traditional manufacturing techniques. The literature on solid titanium implants has suggested greater subsidence compared with PEEK interbody spacers for spinal fusion and greater bone resorption compared with cobalt-chromium femoral stems in total hip arthroplasty. Other evidence suggests that porous titanium implants produced by 3D-printing may improve osteointegration and reduce aseptic loosening. Due to these conflicting finding, clinical trials are needed to evaluate how 3D-printed implants perform over the long-term compared with conventionally manufactured devices. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have typical bone and joint anatomy and are undergoing standard orthopedic procedures who receive a patient-matched 3D printed implant, the evidence includes no comparative studies. The relevant outcomes include symptoms, functional outcomes, and quality of life. Studies are needed to determine whether patient-matched implants improve outcomes compared with conventional implants. It is noted that other methods for the customization of orthopedic procedures, specifically patient-specific cutting guides and sex-specific implants, have failed to demonstrate improvements in health outcomes. Demonstration of improvement in key outcome measures is needed to justify the greater resource utilization (eg, time, imaging) of patient-matched 3D printed devices. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have bone or joint deformity requiring a custom orthopedic implant who receive a custom 3D printed implant, the evidence includes case series. The relevant outcomes include symptoms, functional outcomes, and quality of life. The largest case series with the longest follow-up is from outside of the United States. The most commonly reported indications are for revision total hip arthroplasty with severe acetabular defects, reconstruction following orthopedic tumor resection, and spinal abnormalities. These cases would require a custom process for design and manufacturing, even with traditional manufacturing methods. Therefore, the design and manufacturing of a single implant with 3D printing is an advantage of this technology. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

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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 NCT04062630a Sacroiliac Joint Stabilization in Long Fusion to the Pelvis:

Randomized Controlled Trial 220 May 2022

NCT03649490a A Prospective Multicenter Study Evaluating the Effect of Implant Material and/or Surface Structure on Progression of Fusion in XLIF® Surgery

300 Aug 2022

NCT04086784 3D-printed Porous Titanium Alloy Cages Versus PEEK Cages: Pedicle Screw Loosening Rate and Fusion Rate in Patients With Osteoporosis (3DCOP)

90 Dec 2022

NCT03647501a Lumbar Fusion With 3D-Printed Porous Titanium Interbody Cages - A Single-Blinded Randomized Controlled Trial Evaluating Nexxt Matrixx(TM) Versus PEEK Cages

70 Sep 2024

NCT02494544a A Prospective, Randomized, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System Versus Off-the-Shelf Replacement

187 Aug 2029

NCT: national clinical trial a Denotes industry-sponsored or cosponsored trial.

Practice Guidelines and Position Statements

American Society for Testing and Material

The American Society for Testing and Material has drafted standards for additive manufacturing.21 The specification on Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion covers additively manufactured titanium-6aluminum-4vanadium components using full-melt powder bed fusion such as electron beam melting and laser melting. The Society states that “the components produced by these processes are used typically in applications that require mechanical properties similar to machined forgings and wrought products. Components

https://www.clinicaltrials.gov/ct2/show/NCT04062630?term=NCT04062630&draw=2&rank=1https://www.clinicaltrials.gov/ct2/show/NCT03649490?term=NCT03649490&draw=2&rank=1https://www.clinicaltrials.gov/ct2/show/NCT04086784?term=NCT04086784&draw=2&rank=1https://www.clinicaltrials.gov/ct2/show/NCT03647501?term=NCT03647501&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02494544?term=NCT02494544&rank=1

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manufactured to this specification are often, but not necessarily, post processed via machining, grinding, electrical discharge machining, polishing, and so forth to achieve desired surface finish and critical dimensions.”

Medicare National Coverage

There is no national coverage determination.

Regulatory Status

The FDA (2017) published guidance for industry and technical considerations for 3D printed medical devices.1 The recommendations in this guidance are intended to supplement any device-specific recommendations and represent FDA’s initial thinking and recommendations. The guidance does not apply to 3D printing at the point-of-care.

FDA expects “that AM [additive manufacturing] devices will follow the same regulatory requirements and submission expectations as the classification and/or regulation to which a non-AM device of the same type is subject.” The required information, characterization, and testing will depend on a variety of factors, such as whether it is an implant or instrument, and whether it is available in standard sizes or is patient-matched.

The FDA has noted that although patient-matched devices are sometimes referred to as customized devices, they are not custom devices meeting custom device exemption requirements under the U.S. Federal Food, Drug, and Cosmetic Act unless they comply with all the criteria of section 520(b). FDA has published guidance for industry and on the custom device exemption act in 2014.2 Custom devices are those created or modified to comply with the order of an individual physician or dentist, do not exceed five units per year, and are reported by the manufacturer to FDA for devices manufactured and distributed under section 520(b) of the Food, Drug, and Cosmetic Act.

Under Section 520(b) of the Food, Drug, and Cosmetic Act, custom devices are exempt from premarket approval (PMA) requirements and conformance to mandatory performance standards.

“A device not covered by an existing marketing approval would require either a PMA or a valid exemption from the requirements to obtain PMA approval in order to be introduced into interstate commerce. Examples of potential valid exemptions or alternatives from the PMA

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requirement include: (1) establishing the substantial equivalence of the new device to a valid predicate device, (2) approval of an Investigational Device Exemption (IDE) or (3) meeting all custom device exemption requirements.”

“Custom Devices are not exempt from any other requirements, including, but not limited to, the Quality System Regulation, including Design Controls (21 CFR Part 820); Medical Device Reporting (21 CFR Part 803); Labeling (21 CFR Part 801); Corrections and Removals (21 CFR Part 806); and Registration and Listing (21 CFR Part 807).”

A custom device may not be marketed to the general public.

The FDA has also noted that most patient-matched devices will fall within the existing regulatory pathway for that device type. In addition to standard labeling, specific labeling information is recommended for AM devices that are patient-matched. The FDA has stated that “modifications to a 510(k)-cleared device that maintain its original intended use and could be clinically studied do not appropriately qualify as a custom device.”

A number of titanium spinal interbody implants with increased roughness and porosity than traditional designs have received marketing clearance by FDA through the 510(k) process. They have a biomechanical stiffness similar to polyetheretherketone cages and less than solid titanium. They include:

• Cascadia™ Cervical and Cascadia ™AN Lordotic Oblique Interbody Systems (K2M)

• CONDUIT (DePuy Synthes)

• EIT (Emerging Implant Technologies)Fortilink IBF system (RTI Surgical)

• Foundation 3D (CoreLink)

• IB3D (Medicrea)

• Modulus XLIF (NuVasive)

• NanoHive interbodies (HD Lifesciences)

• Spira-C (Camber)

• Tirbolox (Captiva Spine)

• Tritanium (Stryker)

A porous 3D printed titanium implants for minimally invasive sacroiliac joint fusion have received 510(k) clearances:

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• iFuse 3D (SI Bone)

Patient matched knee implants include:

• ConforMIS iTotal® Cruciate Retaining Knee Replacement System (ConforMIS)

• ConforMIS iTotal® Posterior Stabilized Knee Replacement System (ConforMIS)

• ConforMIS iUni® Unicondylar Knee Replacement System (ConforMIS)

• ConforMIS iTotal Hip system (ConforMIS).

References

1. U.S. Food and Drug Administration. Technical considerations for additive manufactured medical devices: Guidance for industry and Food and Drug Administration staff. 2017; https://www.fda.gov/files/medical%20devices/published/Technical-Considerations-for-Additive-Manufactured-Medical-Devices---Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdf. Accessed August 2020.

2. U.S. Food and Drug Administration. Custom device exemption: Guidance for industry and Food and Drug Administration Staff. 2014; https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm415799.pdf. Accessed August 2020.

3. Chen Y, Wang X, Lu X, et al. Comparison of titanium and polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical spondylotic myelopathy: a prospective, randomized, control study with over 7-year follow-up. Eur Spine J. Jul 2013; 22(7): 1539-46. PMID 23568254

4. Seaman S, Kerezoudis P, Bydon M, et al. Titanium vs. polyetheretherketone (PEEK) interbody fusion: Meta-analysis and review of the literature. J Clin Neurosci. Oct 2017; 44: 23-29. PMID 28736113

5. Mokawem M, Katzouraki G, Harman CL, et al. Lumbar interbody fusion rates with 3D-printed lamellar titanium cages using a silicate-substituted calcium phosphate bone graft. J Clin Neurosci. Oct 2019; 68: 134-139. PMID 31351704

6. R Krafft P, Osburn B, C Vivas A, et al. Novel Titanium Cages for Minimally Invasive Lateral Lumbar Interbody Fusion: First Assessment of Subsidence. Spine Surg Relat Res. 2020; 4(2): 171-177. PMID 32405565

7. Maurer TB, Ochsner PE, Schwarzer G, et al. Increased loosening of cemented straight stem prostheses made from titanium alloys. An analysis and comparison with prostheses made of cobalt-chromium-nickel alloy. Int Orthop. 2001; 25(2): 77-80. PMID 11409456

8. Arabnejad S, Johnston B, Tanzer M, et al. Fully porous 3D printed titanium femoral stem to reduce stress-shielding following total hip arthroplasty. J Orthop Res. Aug 2017; 35(8): 1774-1783. PMID 27664796

9. Castagnini F, Bordini B, Stea S, et al. Highly porous titanium cup in cementless total hip arthroplasty: registry results at eight years. Int Orthop. Aug 2019; 43(8): 1815-1821. PMID 30141142

10. Cohen RG, Sherman NC, James SL. Early Clinical Outcomes of a New Cementless Total Knee Arthroplasty Design. Orthopedics. Nov 01 2018; 41(6): e765-e771. PMID 30168838

https://www.fda.gov/files/medical%20devices/published/Technical-Considerations-for-Additive-Manufactured-Medical-Devices---Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdfhttps://www.fda.gov/files/medical%20devices/published/Technical-Considerations-for-Additive-Manufactured-Medical-Devices---Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdfhttps://www.fda.gov/files/medical%20devices/published/Technical-Considerations-for-Additive-Manufactured-Medical-Devices---Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdfhttps://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm415799.pdf

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11. Patel V, Kovalsky D, Meyer SC, et al. Minimally invasive lateral transiliac sacroiliac joint fusion using 3D-printed triangular titanium implants. Med Devices (Auckl). 2019; 12: 203-214. PMID 31239791

12. Cher D, Wroe K, Reckling WC, et al. Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion. Med Devices (Auckl). 2018; 11: 337-343. PMID 30319290

13. Cheng T, Zhu C, Wang J, et al. No clinical benefit of gender-specific total knee arthroplasty. Acta Orthop. Aug 2014; 85(4): 415-21. PMID 24954488

14. Citak M, Kochsiek L, Gehrke T, et al. Preliminary results of a 3D-printed acetabular component in the management of extensive defects. Hip Int. May 2018; 28(3): 266-271. PMID 29218689

15. Mao Y, Xu C, Xu J, et al. The use of customized cages in revision total hip arthroplasty for Paprosky type III acetabular bone defects. Int Orthop. Oct 2015; 39(10): 2023-30. PMID 26285669

16. Liang H, Ji T, Zhang Y, et al. Reconstruction with 3D-printed pelvic endoprostheses after resection of a pelvic tumour. Bone Joint J. Feb 2017; 99-B(2): 267-275. PMID 28148672

17. Burnard JL, Parr WCH, Choy WJ, et al. 3D-printed spine surgery implants: a systematic review of the efficacy and clinical safety profile of patient-specific and off-the-shelf devices. Eur Spine J. Jun 2020; 29(6): 1248-1260. PMID 31797140

18. Li H, Qu X, Mao Y, et al. Custom Acetabular Cages Offer Stable Fixation and Improved Hip Scores for Revision THA With Severe Bone Defects. Clin Orthop Relat Res. Mar 2016; 474(3): 731-40. PMID 26467611

19. Ding HW, Yu GW, Tu Q, et al. Computer-aided resection and endoprosthesis design for the management of malignant bone tumors around the knee: outcomes of 12 cases. BMC Musculoskelet Disord. Nov 22 2013; 14: 331. PMID 24267157

20. Luo W, Huang L, Liu H, et al. Customized Knee Prosthesis in Treatment of Giant Cell Tumors of the Proximal Tibia: Application of 3-Dimensional Printing Technology in Surgical Design. Med Sci Monit. Apr 07 2017; 23: 1691-1700. PMID 28388595

21. American Society for Testing and Material. Additive manufacturing technology standards. n.d.; https://www.astm.org/Standards/additive-manufacturing-technology-standards.html. Accessed August 2020.

History

Date Comments 08/01/18 New policy, approved July 10, 2018. Add to Surgery section. Policy created with

literature review through March 2018. Three-dimensional printed implants are considered medically necessary for custom implants for patients with bone or joint deformity and investigational for standard and patient-matched implants.

10/01/19 Annual Review, approved September 5, 2019. Policy updated with literature review through May 2019; references added. Policy statements unchanged.

10/01/20 Annual Review, approved September 1, 2020. Policy updated with literature review through June 2020; references added. Policy statements 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

https://www.astm.org/Standards/additive-manufacturing-technology-standards.html

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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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mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga اللخ من ھاعلي لوالحص تريد التي التغطية LifeWise Health Plan of Washington. قدawan ti bayadanyo. Tumawag iti numero nga 800-592-6804 (TTY: 800-842-5357).

على اظلحفل نةعيم يخراوت في إجراء التخاذ اجتحت قدو . اإلشعار ذاھ في مھمة يخراوت ھناك تكون ةدمساعوال تالوملمعا ھذه على ولحصال لك يحق .يفكالتال دفع في دةاعسملل أو يةحصلا تكطيتغ

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

้

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Washington. ອາດຈະມີ ນທີ າຄັນໃນແຈ້ງການນ້ີ . ທ່ານອາດຈະຈໍ າເປັ ນຕ້ອງດໍ າ ເນີ ນການຕາມກໍ ານົດເວລາສະເພາະເພື່ ອຮັກສາຄວາມຄຸ້ມຄອງປະກັນສຸຂະພາບ ຫຼື ຄວາມຊ່ວຍເຫຼື ອເລ່ື ອງຄ່າໃຊ້ າຍຂອງທ່ານໄວ້ . ທ່ານມີ ດໄດ້ ບຂໍ້ ນນ້ີ ແລະ ຄວາມ ວຍເຫຼື ອເປັ ນພາສາຂອງທ່ານໂດຍບໍ່ ເສຍຄ່າ. ໃຫ້ໂທຫາ 800-592-6804

(TTY: 800-842-5357).

ភាសាែខមរ (Khmer):

ມູ ຮັ ສິ

ມູ ຂໍ້

ສໍ

ຈ່

ວັ

ມູ ຂໍ້ ມີ ໝັ

ຊ່

Română (Romanian): Prezenta notificare conține informații importante. Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin LifeWise Health Plan of Washington. 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 800-592-6804 (TTY: 800-842-5357).

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Español (Spanish): Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de LifeWise Health Plan of Washington. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de

េសចកតជី ូ នដំ ងេនះមានព័ ី

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

មានយ៉ា ំ ់ ត ងសខាន។ េសចក ំណឹងេនះរបែហល

កតាមរយៈ

ងេសចកត ី នដណងេនះ។ អករបែហលជារតវការបេញញសមតភាព ដល់ ណត់ ំ ឹ ន ូ ច ថ កំ ជូ កន ុ determinadas fechas para mantener su cobertura médica o ayuda con los អន ៃថងជាកចបាសនានា េដ ី ឹ ុ ៉ ប់ ុខភាពរបស់ ក ឬរបាក់ costos. Usted tiene derecho a recibir esta información y ayuda en su idioma ់ ់ ើមបនងរកសាទកការធានារា រងស

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

ទធ នួ ល។ អន នួ ិ ួលព័ ៌ ិងជំ ន ុងភាសារបស ទទ តមានេនះ ន យេនៅក អន ់

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

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

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(

Polskie (Polish): To ogłoszenie może zawierać ważne informacje. To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez LifeWise Health Plan of Washington. 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 800-592-6804 (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 LifeWise Health Plan of Washington. 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 esta informação e ajuda em seu idioma e sem custos. Ligue para 800-592-6804 (TTY: 800-842-5357).

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