MEDICAL POLICY – 6.01.502 Single Photon Emission Computed (SPECT) for Non-cardiac Indications

Effective Date: June 1, 2021 RELATED MEDICAL POLICIES: Last Revised: May 4, 2021 6.01.54 Dopamine Transporter Imaging with Single-photon Emission Computed Replaces: N/A Tomography

Select a hyperlink below to be directed to that section.

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

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

Introduction

SPECT is a type of nuclear imaging test that uses a radioactive dye, also called a tracer, and a special camera to create a three-dimensional (3-D) image of the organs in the body. The images created by tracking the dye in the blood stream can show areas of increased/decreased blood flow and progressive changes in the body. SPECT is proposed to help diagnose or monitor certain tumors, bone disorders, and heart problems.

SPECT imaging of the brain for mental health disorders is used as a research tool in clinical trials. Research has not shown the utility of SPECT brain imaging for differential diagnosis or for assessing or predicting an individual’s risk of getting a mental health disorder.

Dopamine transporter imaging with single-photon emission computed tomography (DAT- SPECT) is addressed in another policy (see Related Medical Policies).

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

Procedure Medical Necessity SPECT scan SPECT scans may be considered medically necessary for any of the following non-cardiac conditions or symptoms: • Brain tumor recurrence versus radiation necrosis • Liver hemangioma versus tumor identification • Localization of abscess, suspected or known localized infection vs. inflammation • Assessment of osteomyelitis (bone vs. soft tissue infection) • Lymphoma evaluation (tumor vs. necrosis) • Neuroendocrine tumors (carcinoid, pheocromoctyoma, thyroid carcinoma, adrenal gland tumors) (OctreoScan™ or metaiodobenzylguanidine [MIBG] scan) • Parathyroid disease • Renal function and renal scarring evaluation (Dimercaptosuccinic acid [DMSA] scan) • Presurgical seizure foci localization for patients with intractable epilepsy (in place of positron emission tomography [PET]) • Vertebral abnormalities evaluation (such as spondylosis, spondylolisthesis, or stress fractures not visible on x-ray) SPECT scan SPECT scans are considered not medically necessary for any of the following conditions or symptoms: • Cerebrovascular accident (also called CVA, , or brain attack) • Subarachnoid hemorrhage • Transient ischemic attack (TIA)

Procedure Investigational SPECT scan SPECT scans are considered investigational for all other non- cardiac conditions, including any of the following: • Attention deficit hyperactivity disorder (ADHD) • Autism spectrum disorders • Colorectal cancer (eg, with CEA-Scan, IMMU-4) • Head trauma – evaluation of brain morphology

Page | 2 of 12 ∞ Procedure Investigational • Mental health disorders (diagnosis, prediction, response to medication) • Movement disorder evaluation • Prostate cancer (eg, with ProstaScint®) • Unclassified dementia evaluation (eg, Alzheimer disease)

Documentation Requirements The medical records submitted for review should document that medical necessity criteria are met. Include history and physical supporting that patient has ANY of the following symptoms or conditions: • Brain tumors, to differentiate between recurrent tumor versus radiation changes, infection • Liver hemangioma, to further define the mass • Localization of abscess, infection, or inflammation • Lymphoma evaluation • Neuroendocrine tumors • Parathyroid disease • Renal function and renal scarring evaluation (dimercaptosuccinic acid [DMSA] scan) • Patients with intractable epilepsy, when seizure focus cannot be localized • Evaluation of vertebral abnormalities (such as spondylosis, spondylolysis, spondylolisthesis, degenerative joint disease/arthritis of the facet joints, stress fractures)

Coding

Code Description HCPCS A9507 Indium in-111 capromab pendetide, diagnostic, per study dose, up to 10 millicuries

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

Page | 3 of 12 ∞ Definition of Terms

Abscess: A mass filled with pus (made up of dead white blood cells and dead tissue, bacteria, and blood serum) that collects anywhere in the body as a result of the body's response to an infection.

Adenoma: A noncancerous (benign) epithelial tumor that may affect various organs in the body. The adenoma often comes from or resembles glandular tissue, though some grow in nonglandular areas.

Autism spectrum disorders: Refers to a group of disorders defined as delays in the development of socialization and communication skills often accompanied by cognitive and language delays.

Carcinoid tumors: Carcinoid tumors are slow growing and usually start in the gastrointestinal tract (anywhere between the stomach and the rectum) or the lung. These tumors make and release (secrete) large amounts of hormones, including cortisol, histamine, insulin and serotonin. Carcinoid tumors are a type of neuroendocrine tumor.

Liver hemangioma: A noncancerous tumor (mass) that forms in or on the liver. It is made up of small blood vessels. Liver hemangiomas are more common in women than men.

Lymphoma: A cancer of the white blood cells (lymphocytes) of the body’s immune system. It develops in the lymph nodes and lymphatic system.

Movement disorders: A group of diseases that includes abnormally slow movement (bradykinesia), rigidity, tremor at rest, and postural instability.

Neuroendocrine tumors: A diverse group of tumors that form from cells of the hormone and nervous systems. They may be found in the intestine and also occur in the thyroid, lung and other parts of the body.

Transient ischemic attack (TIA): A temporary lack of adequate blood and oxygen (ischemia) to the brain. The neurological signs and symptoms are similar to a brain attack (stroke), but go away within a short period of time. This may also be referred to as a mini-stroke.

Evidence Review

Page | 4 of 12 ∞ Background

SPECT is an imaging modality that provides information about the functional level of a particular body part. It requires the injection of a low-level radioactive isotope (chemical tracer) into the bloodstream. Images then reflect how the tracer is processed by the body. This is in contrast to structural information provided by CT, MRI or ultrasound. Scans are made with a device that detects radioactivity in the body. A SPECT tomograph generates detailed information as the radiotracers used with a SPECT attach to elements appropriate for obtaining specific information. An example of this is how antibodies attach to specific types of tumors. A radiotracer can be attached to an antibody that will then bind to a tumor, which is then identified and located by a SPECT scan.

SPECT provides information about the cellular or level of chemical activity within an organ or system, including structural information about that system. This process can show areas of increased activity, such as inflammation seen in an abscess. Patterns of distribution can then be correlated with particular diseases. The selection of a radiotracer and imaging protocol is specific to the disease process being investigated. SPECT cameras can image large areas of the body as the emitted radiation from the radiotracers travel through the body.

Information obtained by SPECT complements or confirms data obtained by other forms of testing and may provide additional information in some situations. For many conditions, SPECT has been found to be as useful as PET, even though PET images tend to be of higher quality than those of SPECT, SPECT tends to be more available. Both PET and SPECT can diagnose disease prior to the onset of clinical symptoms or structural manifestations of disease as they provide information regarding the functional level of a body system.

Abscess/Infection

Labeled white blood cells are infused prior to SPECT imaging of the suspected clinical site of infection. This infusion helps with localization of tissue inflammation.1

Autism Spectrum Disorders

Autism spectrum disorders can be difficult to diagnose due to the variety and severity of the presentation of symptoms. The American Academy of Neurology Practice Guideline states the following: "There is no evidence to support a role for functional neuroimaging studies in the clinical diagnosis of autism at the present time"25

Page | 5 of 12 ∞

Surgical Repair

SPECT can be useful in distinguishing between tumor regrowth and radiation necrosis in patients with cerebral metastases.2

Cerebrovascular Disease (CVA, stroke, brain attack, TIA)

The use of SPECT has become outdated for the evaluation and management of cerebrovascular disease, including cerebrovascular accidents (CVA or stroke), subarachnoid hemorrhages, and transient ischemic attacks (TIA). Newer imaging techniques are more common such as computed tomography (CTA) and magnetic resonance angiography (MRA).3-5

Epilepsy Seizure Foci

Ictal SPECT may be applicable for patients being considered for surgery to treat intractable epilepsy when seizure focus cannot be localized by EEG, video-EEG, or MRI. Effective surgical treatment of patients with intractable epilepsy is dependent on accurate localization of the epileptic focus and precise delineation of the eliptogenic region. Ictal SPECT uses the physiologic increase in regional cerebral blood flow during seizures to localize the epileptogenic region. This testing aids in identifying the source or sources of the seizures as well as assess brain function. SPECT may offer a safe and accurate alternative to quantitative MRI or PET for the pre-surgical ictal detection of seizure focus. It should be performed in a hospital setting.6,7

Kidney (renal)

Using Technetium-99m labeled dimercaptosuccinic acid (DSMA) for diagnostic imaging may be useful to evaluate kidney function and identify scarring that may be the result of frequent infections.8,9 The National Institute for Health and Clinical Excellence 2007 guideline recommends DMSA scanning when the diagnosis cannot be confirmed by Doppler ultrasound.10 The American Urological Association 2010 Clinical Practice Guideline recommends DMSA scan when a renal ultrasound is abnormal in children with vesicoureteral reflux to detect the presence of any renal scarring.11

Page | 6 of 12 ∞ Liver Hemangioma versus Primary Hepatoma or Metastases

Technetium-labeled red blood cells are infused prior to SPECT imaging of the liver. There is risk of hemorrhage in a percutaneous biopsy of liver hemangiomas, so non-invasive methods of testing are useful for differentiating between the blood pool of an hepatic hemangioma from other solid hepatic masses. Review articles and published studies support SPECT as an appropriate diagnostic tool to differentiate between hepatic lesions versus hemangiomas.12

Lymphoma

SPECT scans may be useful to distinguish tumor from radiation necrosis in the chest and abdomen. An initial study can be compared with a follow-up study after the completion of treatment. SPECT is not appropriate for initial staging of lymphoma.13

Mental Health Disorders

SPECT imaging of the brain for mental health disorders is used as a research tool in clinical trials. The National Institute of Mental Health (NIMH) made the following statement in their brochure titled “Neuroimaging and Mental Illness: A window into the brain”:

No scientific studies to date have shown that a brain scan by itself can be used for diagnosing a mental illness or to learn about a person’s risk for disease. Brain scans alone cannot be used to diagnose a mental disorder, such as autism, anxiety, depression, schizophrenia, or bipolar disorder. Other types of tests are needed for a mental illness to be properly diagnosed.14,15

Mild Cognitive Impairment (MCI) Conversion to Alzheimer’s Disease (AD)

The utility of SPECT to predict conversion from mild cognitive impairment (MCI) to Alzheimer’s disease (AD) is limited.16,17 A technology assessment of SPECT for dementia and AD by the Institute for Clinical Effectiveness and Health Policy concluded: “SPECT has not clearly demonstrated its usefulness in assessing patients with dementia, and it has no precise indications for diagnosis, evaluation of prognosis or monitoring response to treatment.”18 Controlled studies of SPECT in AD show the sensitivity of this testing varies from 50 to 95%. The

Page | 7 of 12 ∞ American Academy of Neurology does not recommend SPECT for routine use in the differential diagnosis of dementia.19

Neuroendocrine Tumors

SPECT for the diagnosis and staging of neuroendocrine tumors may be done using a monoclonal antibody (OctreoScan™) or I-131 meta-iodobenzyl-guanidine (MIBG) because carcinoids and other neuroendocrine tumors have somatostatin receptors and can be imaged with somatostain analogs tagged with an appropriate radioisotope.20, 21

Parathyroid Disease

Guidelines on parathyroid from the Society of Nuclear Medicine22 state that there is a developing consensus that SPECT and SPECT/CT are most useful for improving the precision of anatomic localization. The Parathyroid Task Group of the European Association of (EANM)21 state that the use of SPECT/CT has a major role for obtaining anatomical details on ectopic foci. However, its use as a routine procedure before target surgery is still investigational. Preliminary data suggest that SPECT/CT has lower sensitivity in the neck area compared to pinhole imaging.22-24

Prostate Cancer

ProstaScint, a monoclonal antibody combined with radioactive indium-111, is used to detect prostate cancer. It is injected into the body and then a is used to locate prostate cancer cells. There is little evidence demonstrating improvements in health outcomes following ProstaScint scans. One study showed 60% progression-free survival (PFS) of 60% for those study participants with a negative scan and 74% for those with a positive scan. The researchers of the study concluded that the individuals with positive scans did not have a statistically significant difference in PFS than those with a negative scan result.26 Pucar concluded that “ProstaScint has no added benefit over other imaging modalities in evaluating post-radical prostatectomy recurrence, due to its low sensitivity for detecting local recurrences and bone metastases.”27

The American College of (ACR) states: “The reliability and usefulness of indium-111 radiolabeled capromab pendetide (a first-generation monoclonal antibody against prostate- specific membrane antigen [PSMA]) scan as a method to stage prostate cancer remains

Page | 8 of 12 ∞ unproven.”28 They also note that the optimal use of the scan remains to be determined as the scans are difficult to interpret and are costly to perform.29

Spondylolysis and Stress Fractures

SPECT scans may be useful in evaluating chronic back or neck pain that is atypical which may be caused by spondylolysis or stress fractures and are undiagnosed by conventional imaging. Bone SPECT may provide diagnostic information in cases of low back pain that is not available with routine imaging. One study of 34 patients with chronic low back pain compared findings from , computed tomography (CT) and with SPECT. The majority of lesions (89%) seen on SPECT corresponded to identifiable disease on CT.30 SPECT was also found to be more sensitive than planar bone scintigraphy in identifying patients with painful defects in the pars interarticularis compared to radiographic evidence of spondolysis and/or spondylolisthesis in 19 adult patients studied. 31 Bencardino et al (2016) in the Expert Panel on Musculoskeletal Imaging. American College of Radiology Appropriateness Criteria states: “planar scintigraphy combined with SPECT is more accurate in diagnosing stress injuries than planar scintigraphy alone.”32

Vertebral Abnormalities

SPECT scans may be useful in evaluating chronic back or neck pain that is atypical which may be caused by spondylolysis or stress fractures and are undiagnosed by conventional imaging studies.30,31

References

1. Bybel B, Brunken RC, DiFilippo FP, Neumann DR, Wu G, Cerqueira MD. SPECT/CT imaging: clinical utility of an emerging technology. Radiographics. 2008 Jul-Aug;28(4):1097-113. PMID 18635631

2. Serizawa T, Saeki N, Higuchi Y et al. Diagnostic value of thallium-201 chloride single-photon emission computerized tomography in differentiating tumor recurrence from radiation injury after gamma knife surgery for metastatic brain tumors. J Neurosurg 2005; 102 (Suppl):266-271. PMID 15662823

3. Lewis DH. Functional brain imaging with cerebral perfusion SPECT in cerebrovascular disease, epilepsy, and trauma. Neurosurg Clin N Am. 1997 Jul;8(3):337-344. PMID9188542

Page | 9 of 12 ∞ 4. Ueda T et al. Outcome in acute stroke with successful intra-arterial thrombolysis and predictive value of initial single photon emission-computed tomography. J Cereb Blood Flow Metab. 1999 Jan;19(1):99-108. PMID 9886360

5. Lewis DH et al. Brain SPECT and the effect of cerebral angioplasty in delayed ischemia due to vasospasm. J Nuc Med, Oct. 1992; Vol. 33, No. 10:1789-1796. PMID 1403146

6. von Oertzen TJ, Mormann F, Urbach H, et al. Prospective use of subtraction ictal SPECT coregistered to MRI (SISCOM) in presurgical evaluation of epilepsy. Epilepsia. 2011; 52(12):2239-2248. PMID 22136078

7. Kumar A, Chugani HT. The role of imaging in epilepsy, Part 1: Sporadic temporal and extratemporal lobe epilepsy. J Nucl Med. 2013 Oct;54(10):1775-1781. PMID 23970368

8. Even-Sapir E, Gutman M, Lerman H et al. Kidney allografts and remaining contralateral donor kidneys before and after transplantation: assessment by quantitative (99m) TC-DMSA SPECT. J Nucl Med 2002; 43(5):584-588. PMID 11994518

9. Mullerad M, Kastin A, Issaq E et al. The value of quantitative 99M technetium dimercaptosuccinic acid renal scintigraphy for predicting postoperative renal insufficiency in patients undergoing nephrectomy. J Urol 2003; 169(1):24-27. PMID 12478094

10. National Institute for Health and Care Excellence. Clinical Guideline[CG54] Urinary tract infection in under 16s: diagnosis and management. Published date: August 2007. Last updated: October 2018. Available at: https://www.nice.org.uk/guidance/cg54 Accessed May 14, 2021.

11. American Urological Association. Clinical Practice Guideline. Management and screening of primary vesicoureteral reflux. Reviewed 2017. Available at: http://www.auanet.org/guidelines/vesicoureteral-reflux-(2010-reviewed-and-validity- confirmed-2017) Accessed May 14, 2021.

12. Jacobson AF, Teefey SA. Cavernous hemangiomas of the liver. Association of sonographic appearance and results of Tc-99m labeled red blood cell SPECT. Clin Nucl Med. 1994;19(2):96-99. PMID 8187411

13. Bockisch A, Freudenberg LS, et al. Hybrid imaging by SPECT/CT and PET/CT: proven outcomes in cancer imaging. Semin Nucl Med. 2009 Jul;39(4):276-289. PMID 19497404

14. American Psychiatric Association. Practice Guideline for the Psychiatric Evaluation of Adults, Third Edition. August 2015. Available at: https://www.psychiatry.org/psychiatrists/practice/clinical-practice-guidelines Accessed May 14, 2021.

15. Farah MJ, Gillihan SJ. The Puzzle of Neuroimaging and Psychiatric Diagnosis: Technology and Nosology in an Evolving Discipline. AJOB neuroscience. 2012;3(4):31-41. PMID 23505613

16. Devanand DP, Van Heertum RL, Kegeles LS, et al. (99m)Tc hexamethyl-propylene-aminoxime single-photon emission computed tomography prediction of conversion from mild cognitive impairment to Alzheimer disease. Am J Geriatr Psychiatry. 2010;18(11):959-972. PMID 20808143

17. McNeill R, Sare GM, Manoharan M, et al. Accuracy of single-photon emission computed tomography in differentiating frontotemporal dementia from Alzheimer’s disease. J Neurol Neurosurg Psychiatry. 2007;78(4):350-355. PMID 17158559

18. Ferrante, D. SPECT for the diagnosis and assessment of dementia and Alzheimer’s disease (summary). Report ITB No. 14. Buenos Aires, Argentina: Institute for Clinical Effectiveness and Health Policy (ICES); 2004.

19. Knopman DS, DeKosky ST, et al. Practice parameter: Diagnosis of dementia (an evidence-based review). Report of the Quality Standards Subcommitte of the American Academy of Neurology. Neurology. 2001;56 (9): 1143-1153

20. Schillaci O, Scopinaro F, Angeletti S, et al. SPECT improves accuracy of somatostatin receptor scintigraphy in abdominal carcinoid tumors. J Nuclear Med. 1996;37(9):1452-1456. PMID 8790191

21. Schillaci O, Corleto VD, Annibale B, et al. Single photon emission computed tomography procedure improves accuracy of somatostatin receptor scintigraphy in gastro-entero pancreatic tumours. Ital J Gastroenterol Hepatol. 1999 Oct; 31 Suppl 2():S186-189. PMID 10604127

22. Greenspan BS, Brown ML, Dillehay GL, et al. The Society of Nuclear Medicine Procedure Guideline for Parathyroid Scintigraphy. Version 3.0. Reston, VA: Society of Nuclear Medicine; June 2004.

Page | 10 of 12 ∞ 23. Hindié E, Ugar O, Fuster D, et al; Parathyroid Task Group of the EANM. 2009 EANM parathyroid guidelines. Eur J Nucl Med Mol Imaging. 2009:36(7):1201-1216. PMID 19471928

24. Tunninen V, Varjo P, Schildt J, et al. Comparison of five parathyroid scintigraphic protocols. Int J Mol Imaging. 2013;2013:921260. PMID 23431436

25. Filipek PS, Accardo PJ, Ashwal S, et al. Practice parameter: screening and diagnosis of autism: report of the Quality Standards Subcommittee of the American Academy of Neurology and the Child Neurology Society. Neurology. 2000; 55(4):468-479. PMID: 10953176

26. Koontz BF, Mouraviev V, Johnson JL, et al. Use of local (111) in-capromab pendetide scan results to predict outcome after salvage radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2008; 71(2):358-361.

27. Pucar D, Sella T, Schöder H. The role of imaging in the detection of prostate cancer local recurrence after radiation therapy and surgery. Curr Opin Urol. 2008; 18(1):87-97.

28. American College of Radiology. ACR Appropriateness Criteria®. Post-treatment Follow-up of Prostate Cancer (Revised 2017). Available at: https://acsearch.acr.org/docs/69369/Narrative/ Accessed May 14, 2021.

29. American College of Radiology. ACR Appropriateness Criteria®. Prostate Cancer — Pretreatment Detection, Staging, and Surveillance (Revised 2016). Available at: https://acsearch.acr.org/docs/69371/Narrative/ Accessed May 14, 2021.

30. Ryan PJ et al. Chronic low back pain: Comparison of bone SPECT with radiography and CT. Radiology 1992, Vol. 182:849-854. PMID 1531544

31. Collier BD et al. Painful spondylolysis of spondylolisthesis studied by radiography and single photon emission computed tomography. Radiology 1985, Vol. 154:207-211. PMID 3155479

32. Bencardino, JT, Stone TJ, Roberts CC, et al.Expert Panel on Musculoskeletal Imaging. ACR Appropriateness Criteria Stress (fatigue/insufficiency) fracture, including sacrum, excluding other vertebrae.. J Am Coll Radiol 2017; 14 (5S): S293-S306. PMID: 28473086. https://acsearch.acr.org/docs/69435/Narrative/ Accessed May 14, 2021.

33. Centers for Medicare & Medicaid Services. National Coverage Decision (NCD) for Single Photon Emission Computed Tomography (SPECT) (220.12). 2002. https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=271&ncdver=1&DocID=220.12&bc=gAAAAAgAAAAAAA%3d%3d& Accessed May 14, 2021.

34. American Academy of Pediatrics. Clinical practice guideline: Diagnosis and evaluation of the child with attention- deficit/hyperactivity disorder. Pediatrics. 2000;105(5):1158-1170.

History

Date Comments 09/01/16 New policy, approved August 9, 2016. Add to Medicine section. SPECT may be considered medically necessary when criteria are met for select non-cardiac indications. SPECT is not medically necessary for cerebrovascular indications. SPECT is investigational when criteria are not met.

06/01/17 Annual review, approved May 23, 2017. Policy reorganized for clarity; no change in policy statements.

07/01/18 Annual Review, approved June 12, 2018. Policy updated with literature search through April 2018, References 10, 11,18, 19, 26-29 added. Added assessment of osteomyelitis

Page | 11 of 12 ∞ Date Comments to medical necessity criteria. Deleted degenerative joint disease/arthritis of the facet joints from the vertebral abnormalities medical necessity criteria.

10/01/19 Annual Review, approved September 5, 2019. Policy updated with literature search through August 2019. References 32 and 33 added. Minor edits made for clarity. Otherwise, policy statements unchanged. Added HCPCS code A9507, removed CPT code 78607.

10/01/20 Annual Review, approved September 1, 2020. Policy reviewed. Reference added. Minor edits for clarity; otherwise policy statements unchanged.

06/01/21 Annual Review, approved May 4, 2021. Policy reviewed. 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 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). ©2021 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.

Page | 12 of 12 ∞

Discrimination is Against the Law Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa Premera Blue Cross complies with applicable Federal civil rights laws and yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee does not discriminate on the basis of race, color, national origin, age, odeeffannoo barbaachisaa qabaachuu danda’a. Guyyaawwan murteessaa disability, or sex. Premera does not exclude people or treat them differently ta’an beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf because of race, color, national origin, age, disability or sex. yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu danda’a. Kaffaltii irraa bilisa haala ta’een afaan keessaniin Premera: odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu. • Provides free aids and services to people with disabilities to communicate Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa. effectively with us, such as: • Qualified sign language interpreters Français (French): • Written information in other formats (large print, audio, accessible Cet avis a d'importantes informations. Cet avis peut avoir d'importantes electronic formats, other formats) informations sur votre demande ou la couverture par l'intermédiaire de • Provides free language services to people whose primary language is not Premera Blue Cross. Le présent avis peut contenir des dates clés. Vous English, such as: 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 • Qualified interpreters d'obtenir cette information et de l’aide dans votre langue à aucun coût. • Information written in other languages Appelez le 800-722-1471 (TTY: 800-842-5357).

If you need these services, contact the Civil Rights Coordinator. Kreyòl ayisyen (Creole):

Avi sila a gen Enfòmasyon Enpòtan ladann. Avi sila a kapab genyen If you believe that Premera has failed to provide these services or enfòmasyon enpòtan konsènan aplikasyon w lan oswa konsènan kouvèti discriminated in another way on the basis of race, color, national origin, age, asirans lan atravè Premera Blue Cross. Kapab genyen dat ki enpòtan nan disability, or sex, you can file a grievance with: avi sila a. Ou ka gen pou pran kèk aksyon avan sèten dat limit pou ka Civil Rights Coordinator - Complaints and Appeals kenbe kouvèti asirans sante w la oswa pou yo ka ede w avèk depans yo. PO Box 91102, Seattle, WA 98111 Se dwa w pou resevwa enfòmasyon sa a ak asistans nan lang ou pale a, Toll free 855-332-4535, Fax 425-918-5592, TTY 800-842-5357 san ou pa gen pou peye pou sa. Rele nan 800-722-1471 Email [email protected] (TTY: 800-842-5357).

You can file a grievance in person or by mail, fax, or email. If you need help Deutsche (German): filing a grievance, the Civil Rights Coordinator is available to help you. Diese Benachrichtigung enthält wichtige Informationen. Diese

Benachrichtigung enthält unter Umständen wichtige Informationen You can also file a civil rights complaint with the U.S. Department of Health bezüglich Ihres Antrags auf Krankenversicherungsschutz durch Premera and Human Services, Office for Civil Rights, electronically through the Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser Office for Civil Rights Complaint Portal, available at Benachrichtigung. Sie könnten bis zu bestimmten Stichtagen handeln https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: müssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten U.S. Department of Health and Human Services zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in 200 Independence Avenue SW, Room 509F, HHH Building Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471 Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD) (TTY: 800-842-5357). Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. Hmoob (Hmong):

Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum Getting Help in Other Languages 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 This Notice has Important Information. This notice may have important Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv information about your application or coverage through Premera Blue no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub Cross. There may be key dates in this notice. You may need to take action dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj by certain deadlines to keep your health coverage or help with costs. You yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob have the right to get this information and help in your language at no cost. ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau Call 800-722-1471 (TTY: 800-842-5357). ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471 (TTY: 800-842-5357). አማሪኛ (Amharic): ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል። ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Iloko (Ilocano): Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል። በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ። Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion

ይገባዎት ይሆናል። ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue አለዎት።በስልክ ቁጥር 800-722-1471 (TTY: 800-842-5357) ይደውሉ። Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti Arabic): partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti) العربية salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti يحوي ھذا اإلشعار معلومات ھامة . قد يحوي ھذا اإلشعار معلومات مھمة بخصوص طلبك أو daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti التغطية التي تريد الحصول عليھا من خالل Premera Blue Cross. قد تكون ھناك تواريخ مھمة .(bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357 في ھذا اإلشعار . وقد تحتاج التخاذ إجراء في تواريخ معينة للحفاظ على تغطيتك الصحية أو للمساعدة في دفع التكاليف . يحق لك الحصول على ھذه المعلومات والمساعدة بلغتك دون تكبد أية تكلفة . اتصل :(Italiano (Italian بـ(TTY: 800-842-5357) 800-722-1471 Questo avviso contiene informazioni importanti. Questo avviso può contenere 中文 (Chinese): informazioni importanti sulla tua domanda o copertura attraverso Premera 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 Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe 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 essere necessario un tuo intervento entro una scadenza determinata per 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 consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. 語得到本訊息和幫助。請撥電話 。 800-722-1471 (TTY: 800-842-5357) Chiama 800-722-1471 (TTY: 800-842-5357).

037338 (07-2016) 日本語 (Japanese): Română (Romanian): 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 Prezenta notificare conține informații importante. Această notificare 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 poate conține informații importante privind cererea sau acoperirea asigurării 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 dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie în aceast notificare. Este posibil s fie nevoie s ac iona i pân la anumite 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 ă ă ă ț ț ă termene limită pentru a vă menține acoperirea asigurării de sănătate sau 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 asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste トが無料で提供されます。800-722-1471 (TTY: 800-842-5357)までお電話 informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471 ください。 (TTY: 800-842-5357).

한국어 (Korean): Pусский (Russian): 본 통지서에는 중요한 정보가 들어 있습니다 . 즉 이 통지서는 귀하의 신청에 Настоящее уведомление содержит важную информацию. Это 관하여 그리고 Premera Blue Cross 를 통한 커버리지에 관한 정보를 уведомление может содержать важную информацию о вашем Premera Blue Cross. 포함하고 있을 수 있습니다 . 본 통지서에는 핵심이 되는 날짜들이 있을 수 заявлении или страховом покрытии через В настоящем уведомлении могут быть указаны ключевые даты. Вам, 있습니다. 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 возможно, потребуется принять меры к определенным предельным 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 . срокам для сохранения страхового покрытия или помощи с расходами. 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 Вы имеете право на бесплатное получение этой информации и 권리가 있습니다 . 800-722-1471 (TTY: 800-842-5357) 로 전화하십시오 . помощь на вашем языке. Звоните по телефону 800-722-1471 (TTY: 800-842-5357). ລາວ (Lao): Fa’asamoa (Samoan): ້ ້ ້ ້ ແຈ້ງການນີ ມີ ຂໍ ມູ ນສໍ າຄັ ນ. ແຈ້ງການນີ ອາດຈະມີ ຂໍ ມູ ນສໍ າຄັ ນກ່ ຽວກັບຄໍ າຮ້ອງສະ Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau ໝັ ກ ຫືຼ ຄວາມຄຸ້ ມຄອງປະກັນໄພຂອງທ່ານຜ່ານ Premera Blue Cross. ອາດຈະມີ ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala ວັນທີ ສໍ າຄັ ນໃນແຈ້ງການນີ້ . ທ່ານອາດຈະຈໍ າເປັ ນຕ້ອງດໍ າເນີ ນການຕາມກໍ ານົ ດ atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua ເວລາສະເພາະເພື່ ອຮັກສາຄວາມຄຸ້ ມຄອງປະກັນສຸ ຂະພາບ ຫືຼ ຄວາມຊ່ວຍເຫືຼ ອເລື່ ອງ 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 ້ ້ ຄ່ າໃຊ້ຈ່າຍຂອງທ່ານໄວ້ . ທ່ານມີ ສິ ດໄດ້ ຮັບຂໍ ມູ ນນີ ແລະ ຄວາມຊ່ວຍເຫືຼ ອເປັ ນພາສາ aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai ຂອງທ່ານໂດຍບໍ່ ເສຍຄ່ າ. ໃຫ້ໂທຫາ 800-722-1471 (TTY: 800-842-5357). 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 徶羶ែខមរ (Khmer): ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357). េសចកតជី ូនដណំ ឹងេនះ掶នព័ត៌掶ន架៉ ងស޶នំ។ ់ េសចកតីជូនដំណឹងេនះរបែហល ᾶ掶នព័ត៌掶ន架៉ ងសំ޶ន់អពំ ីទរមង់ ែបបបទ ឬζរ殶៉ បរង់ របសអ់ នក㾶មរយៈ Español (Spanish): Premera Blue Cross ។ របែហលᾶ掶ន ζលបរ េចិ ឆទសំ޶ន់េ俅កន ុងេសចកតជី ូន Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a ដណំ ងេនះ។ឹ អនករបែហលᾶរតវζរបេញូ ច ញសមត徶ពថ ដលក់ ណតំៃថ ់ ងᾶកច厶់ ស់ través de Premera Blue Cross. Es posible que haya fechas clave en este 侶侶 េដើមបីនងរកឹ 羶ទកζរ䮶侶ុ 殶៉ បរង់ សខ徶ពរបសុ ់អនក ឬរ厶កជ់ ំនួយេចញៃថល។ aviso. Es posible que deba tomar alguna medida antes de determinadas អនក掶នសទិ ធទទិ ួលព័ត掶នេ៌ នះ និងជំនួយេ俅កន ុង徶羶របស់អនកេ⮶យមនអសិ fechas para mantener su cobertura médica o ayuda con los costos. Usted លយេឡុ ើយ។ សូ មទូរស័ពទ 800-722-1471 (TTY: 800-842-5357)។ tiene derecho a recibir esta información y ayuda en su idioma sin costo alguno. Llame al 800-722-1471 (TTY: 800-842-5357).

ਪ ੰ ਜਾਬੀ (Punjabi): Tagalog (Tagalog): ਇਸ ਨ ੋ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨ ੋ ਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ƒ ਤੁਹਾਡੀ Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon ਕਵਰਜੇ ਅਤ ੇ ਅਰਜੀ ਬਾਰ ੇ ਮਹ ੱ ਤਵਪਰਨੂ ਜਾਣਕਾਰੀ ਹ ੋ ਸਕਦੀ ਹ ੈ . ਇਸ ਨ ੋ ਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ . tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue ਹੋ ਸਕਦੀਆਂ ਹਨ ਜੇਕਰ ਤਸੀੁ ਜਸਹਤ ਕਵਰਜੇ ਿਰੱ ਖਣੀ ਹਵੋ ੇ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱ ਚ ਮਦਦ ਦੇ Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring ਇਛ ੱ ੁਕ ਹ ੋ ਤ拓 ਤਹਾਨ ੁ ੰ ੂ ਅ ੰ ਤਮ ਤਾਰੀਖ਼ ਤ ƒ ਪਿਹਲ拓 ਕੁੱ ਝ ਖਾਸ ਕਦਮ ਚੱ ਕਣ ੁ ਦੀ ਲੋੜ ਹ ੋ ਸਕਦੀ ਹ ੈ ,ਤੁਹਾਨੰ ੂ mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang ਮਫ਼ਤੁ ਿਵੱ ਚ ਤ ੇ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ੱ ਚ ਜਾਣਕਾਰੀ ਅਤ ੇ ਮਦਦ ਪਾਪਤ㘰 ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹੈ ,ਕਾਲ panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na 800-722-1471 (TTY: 800-842-5357). walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 .(Farsi): (TTY: 800-842-5357) فارسی اين اعالميه حاوی اطالعات مھم ميباشد .اين اعالميه ممکن است حاوی اطالعات مھم درباره فرم :(ไทย (Thai تقاضا و يا پ وشش بيمه ای شما از طريق Premera Blue Cross باشد . به تاريخ ھای مھم در ั ประกาศนมข้ี ี ้อมลส ู ําคญ ั ประกาศนอาจม ้ี ีข ้อมลท ู ่ีส ําคญเก ั ่ียวกบการการสม ัครหร ั ือขอบเขตประกน اين اعالميه توجه نماييد .شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه . สขภาพของคุณผ ุาน ่ Premera Blue Cross และอาจมีก ําหนดการในประกาศนี ้ คณอาจจะต ุ ้อง ھای درمانی تان، به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد شما حق اين را داريد که اين اطالعات و ک مک را به زبان خود به طور رايگان دريافت نماييد . برای کسب ี่ ดําเน ินการภายในกาหนดระยะเวลาท ํ ่ีแนนอนเพ ่ ่ือจะร ักษาการประกนส ัขภาพของค ุณหร ุ ือการช ่วยเหล ือท اطالعات با شماره 1471-722-800 (کاربران TTY تماس باشماره 5357-842-800) تماس มคี่้่าใชจาย คณม ุีิิ่ี้ัู้สทธทจะไดรบขอมลและความชวยเหล ่ ื้ีอนในภาษาของคณโดยไม ุ่มค ี่้่าใชจาย โทร برقرار نماييد . 800-722-1471 (TTY: 800-842-5357) Polskie (Polish): To og oszenie mo e zawiera wa ne informacje. To og oszenie mo e ł ż ć ż ł ż Український (Ukrainian): zawiera wa ne informacje odno nie Pa stwa wniosku lub zakresu ć ż ś ń Це повідомлення містить важливу інформацію. Це повідомлення świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na може містити важливу інформацію про Ваше звернення щодо kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie страхувального покриття через Premera Blue Cross. Зверніть увагу на przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub ключові дати, які можуть бути вказані у цьому повідомленні. Існує pomocy zwi zanej z kosztami. Macie Pa stwo prawo do bezp atnej ą ń ł імовірність того, що Вам треба буде здійснити певні кроки у конкретні informacji we własnym języku. Zadzwońcie pod 800-722-1471 кінцеві строки для того, щоб зберегти Ваше медичне страхування або (TTY: 800-842-5357). отримати фінансову допомогу. У Вас є право на отримання цієї

інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за Português (Portuguese): номером телефону 800-722-1471 (TTY: 800-842-5357). Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio Tiếng Việt (Vietnamese): do Premera Blue Cross. Poderão existir datas importantes neste aviso. Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông Talvez seja necessário que você tome providências dentro de tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua determinados prazos para manter sua cobertura de saúde ou ajuda de chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông custos. Você tem o direito de obter esta informação e ajuda em seu idioma báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357). 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).