5.01.586 intravenous anesthetics for the treatment of chronic … · 2020-06-05 · 100 patients...

12
MEDICAL POLICY – 5.01.586 Intravenous Anesthetics for the Treatment of Chronic Pain and Psychiatric Disorders BCBSA Ref. Policy: 5.01.16 Effective Date: Feb. 1, 2020 Last Revised: Jan. 9, 2020 Replaces: 5.01.16 RELATED MEDICAL POLICIES: None Select a hyperlink below to be directed to that section. POLICY CRITERIA | CODING | RELATED INFORMATION EVIDENCE REVIEW | REFERENCES | HISTORY Clicking this icon returns you to the hyperlinks menu above. Introduction Anesthetics are drugs to control pain. Anesthesia can be used to aid relaxation, block pain, or make a person unconscious during surgery. A local anesthetic is used to block pain in a small part of the body. Regional anesthesia is used to block pain in larger areas of the body, like the arms or legs. General anesthesia affects the whole body and makes a person unconscious. Different types of anesthesia have been well studied and are approved by the Food and Drug Administration for specific uses. Other uses of anesthesia have not been as well studied. One area of current inquiry is the use of certain anesthesias given intravenously (through a vein) to try to treat pain from conditions like complex regional pain syndrome, fibromyalgia, or chronic headache. Another area of inquiry is the use of anesthesias for depression, anxiety, or other psychiatric symptoms or disorders. Using intravenous anesthetic for chronic pain or for psychiatric disorders is investigational (unproven). More and larger studies are needed in both of these areas. 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.

Upload: others

Post on 12-Jul-2020

2 views

Category:

Documents


0 download

TRANSCRIPT

  • MEDICAL POLICY – 5.01.586

    Intravenous Anesthetics for the Treatment of Chronic Pain

    and Psychiatric Disorders BCBSA Ref. Policy: 5.01.16

    Effective Date: Feb. 1, 2020

    Last Revised: Jan. 9, 2020

    Replaces: 5.01.16

    RELATED MEDICAL POLICIES:

    None

    Select a hyperlink below to be directed to that section.

    POLICY CRITERIA | CODING | RELATED INFORMATION

    EVIDENCE REVIEW | REFERENCES | HISTORY

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

    Introduction

    Anesthetics are drugs to control pain. Anesthesia can be used to aid relaxation, block pain, or

    make a person unconscious during surgery. A local anesthetic is used to block pain in a small

    part of the body. Regional anesthesia is used to block pain in larger areas of the body, like the

    arms or legs. General anesthesia affects the whole body and makes a person unconscious.

    Different types of anesthesia have been well studied and are approved by the Food and Drug

    Administration for specific uses. Other uses of anesthesia have not been as well studied. One

    area of current inquiry is the use of certain anesthesias given intravenously (through a vein) to

    try to treat pain from conditions like complex regional pain syndrome, fibromyalgia, or chronic

    headache. Another area of inquiry is the use of anesthesias for depression, anxiety, or other

    psychiatric symptoms or disorders. Using intravenous anesthetic for chronic pain or for

    psychiatric disorders is investigational (unproven). More and larger studies are needed in both

    of these areas.

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

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

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

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

    service may be covered.

  • Page | 2 of 10 ∞

    Policy Coverage Criteria

    Service Investigational Intravenous infusion of

    anesthetics

    Intravenous infusion of anesthetics (eg, ketamine or lidocaine)

    for the treatment of chronic pain, including but not limited to

    chronic neuropathic pain, chronic daily headache, and

    fibromyalgia, is considered investigational.

    Intravenous infusion of ketamine for the treatment of

    depression, anxiety, or other psychiatric symptoms or

    disorders, is considered investigational.

    Coding

    Code Description

    CPT 96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug);

    initial, up to 1 hour

    96366 Each additional hour (list separately in addition to code for primary procedure)

    96374 Therapeutic, prophylactic, or diagnostic injection (specify substance or drug);

    intravenous push, single or initial substance/drug

    HCPCS

    J2001 Injection, lidocaine hydrochloride for intravenous infusion, 10 mg

    J3490 Unclassified drugs

    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

  • Page | 3 of 10 ∞

    Evidence Review

    Description

    Intravenous (IV) infusion of lidocaine or ketamine has been investigated for the treatment of

    migraine and chronic daily headache, fibromyalgia, and chronic neuropathic pain. Chronic

    neuropathic pain disorders include phantom limb pain, post-herpetic neuralgia, complex

    regional pain syndrome, diabetic neuropathy, and pain related to stroke or spinal cord injuries.

    An IV infusion of ketamine has also been investigated for the treatment of depression, anxiety,

    post-traumatic stress disorder (PTSD), and obsessive-compulsive disorder. For these

    applications, one or more courses of IV infusion would be administered over several hours or

    several days.

    Background

    Intravenous Anesthetic Agents

    Courses of intravenous (IV) anesthetic agents may be given in the inpatient or outpatient setting

    as part of a pain management program, with the infusion of a subanesthetic dose preceded by a

    bolus infusion to achieve desired blood levels sooner. Treatment protocols for the initial cycle

    may include infusion of subanesthetic doses of one to six hours for up to ten days.

    Lidocaine

    Lidocaine, which prevents neural depolarization through effects on voltage-dependent sodium

    channels, is also used systemically for the treatment of arrhythmias. Adverse effects for lidocaine

    are common, can be mild to moderate, and include general fatigue, somnolence, dizziness,

    headache, periorbital and extremity numbness and tingling, nausea, vomiting, tremors, and

    changes in blood pressure and pulse. Severe adverse events may include arrhythmias, seizures,

    loss of consciousness, confusion, or even death. Lidocaine should only be given intravenously to

    patients with normal conduction on electrocardiography and normal serum electrolyte

    concentrations to minimize the risk of cardiac arrhythmias.

  • Page | 4 of 10 ∞

    Ketamine

    Ketamine is an antagonist of the N-methyl-D-aspartate receptor and a dissociative anesthetic. It

    is the sole anesthetic agent approved for diagnostic and surgical procedures that do not require

    skeletal muscle relaxation. Respiratory depression may occur with overdosage or too rapid a rate

    of administration of ketamine; it should be used by or under the direction of physicians

    experienced in administering general anesthetics. Ketamine is a schedule III controlled

    substance. Psychological manifestations vary in severity from pleasant dream-like states to

    hallucinations and delirium; further, these manifestations can be accompanied by confusion,

    excitement, aggression, or irrational behavior. The occurrence of adverse events with IV

    anesthetics may be reduced by the careful titration of subanesthetic doses. However, the

    potential benefits of pain control must be carefully weighed against the potential for serious,

    harmful adverse events.

    Indications

    IV administration of anesthetic has been reported for various conditions, including chronic

    headache, chronic pain of neuropathic origin, fibromyalgia, depression, and obsessive-

    compulsive disorders.

    Chronic daily headache is defined as a headache disorder that occurs more than 15 days a

    month for at least 3 months. Chronic daily headache includes chronic migraine, new daily

    persistent headache, hemicranias continua, and chronic tension-type headache.

    Neuropathic pain is often disproportionate to the extent of the primary triggering injury and

    may consist of thermal or mechanical allodynia, dysesthesia, and/or hyperalgesia. Allodynia is

    pain that occurs from a stimulus that normally does not elicit a painful response (eg, light touch,

    warmth). Dysesthesia is a constant or ongoing unpleasant or electrical sensation of pain.

    Hyperalgesia is an exaggerated response to normally painful stimuli. In the latter, symptoms

    may continue longer (eg, ≥6 months) than clinically expected after an illness or injury. It is

    proposed that chronic neuropathic pain results from peripheral afferent sensitization,

    neurogenic inflammation, and sympathetic afferent coupling, along with sensitization and

    functional reorganization of the somatosensory, motor, and autonomic circuits in the central

    nervous system. Therefore, treatments focus on reducing activity and desensitizing pain

    pathways, thought to be mediated through N-methyl-D-aspartate receptors in the peripheral

    and central nervous system. Sympathetic ganglion blocks with lidocaine have been used to treat

    sympathetically maintained chronic pain conditions, such as complex regional pain syndrome

    (previously known as reflex sympathetic dystrophy). Test infusion of an anesthetic has also been

  • Page | 5 of 10 ∞

    used in treatment planning to assess patient responsiveness to determine whether medications,

    such as oral mexiletine or oral ketamine, may be effective. A course of IV lidocaine or ketamine,

    usually at subanesthetic doses, has also been examined. This approach for treating chronic

    neuropathic pain differs from continuous subcutaneous or IV infusion of anesthetics for

    managing chronic pain conditions, such as terminal cancer pain, which is not discussed herein.

    Fibromyalgia is a chronic state of widespread pain and tenderness. Although fibromyalgia is

    generally considered to be a disorder of central pain processing or central sensitization, others

    have proposed that the nerve stimuli causing pain originates mainly in the muscle, causing both

    widespread pain and pain on movement. There are focal areas of hyperalgesia, or tender points,

    which tend to occur at muscle tendon junctions. Biochemical changes associated with

    fibromyalgia include alterations in N-methyl-D-aspartate receptors, low levels of serotonin,

    suppression of dopamine-releasing neurons in the limbic system, dysfunction of the

    hypothalamic-pituitary-adrenal axis, and elevated substance P levels. Fibromyalgia is typically

    treated with neuropathic pain medications such as pregabalin, non-narcotic pain relievers, or

    low doses of antidepressants.

    The use of IV ketamine has also been reported for treatment-resistant depression, defined as

    depression that does not respond adequately to appropriate courses of antidepressant

    medications. Particularly challenging are patients with treatment-resistant depression with

    suicidal ideation. Several studies are ongoing to test the efficacy of IV ketamine in patients with

    suicidal ideation who present to the emergency department.

    Summary of Evidence

    For individuals who have chronic pain syndromes (eg, neuropathic pain or fibromyalgia) who

    receive a course of IV anesthetics (eg, lidocaine, ketamine), the evidence includes several

    randomized controlled trials. Relevant outcomes are symptoms, change in disease status,

    morbid events, functional outcomes, quality of life, medication use, and treatment-related

    morbidity. Several RCTs have been performed using IV lidocaine or ketamine for postherpetic

    neuralgia (PHN), complex regional pain syndrome (CRPS), and diabetic neuropathy. Trials have

    failed to show a durable effect of lidocaine infusion on chronic pain. Two trials with a total of

    100 patients provide limited evidence that courses of IV ketamine may provide temporary relief

    (2 to 4 weeks) to some chronic pain patients. Neither of the RCTs with ketamine infusion used

    an active control, raising the possibility of placebo effects. Overall, the intense treatment

    protocols, the severity of adverse events, and the limited treatment durability raise questions

    about the net health benefit of this procedure. Additional clinical trials are needed to evaluate

  • Page | 6 of 10 ∞

    the long-term efficacy and safety of repeat courses of IV anesthetics for chronic pain. The

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

    For individuals who have psychiatric disorders (eg, treatment resistant depression (TRD), anxiety,

    PTSD, obsessive-compulsive disorder) who receive a course of IV ketamine, the evidence

    consists of randomized controlled trials. Relevant outcomes are symptoms, change in disease

    status, morbid events, functional outcomes, quality of life, medication use, and treatment-

    related morbidity. Two publications of double-blind trials were identified that compared

    repeated ketamine infusion with an infusion of saline for TRD. There is a possibility of

    publication bias due to the lack of publication of many other small trials that failed to show any

    benefit. One study with 26 patients found no significant difference in a depression scale at the

    end of infusion. A larger RCT (n=68) found a significantly greater improvement in a depression

    scale during the 4-week infusion period, but the effect diminished over 3 weeks post-infusion.

    The trial did not use an active control in addition to a placebo arm, raising the possibility of

    placebo effects. Common side effects of ketamine infusion include headache, anxiety,

    dissociation, nausea, and dizziness. The intense treatment protocols, the severity of adverse

    events, and the limited treatment durability raise questions about the net health benefit of this

    procedure. High-quality clinical trials, several of which are in progress, are needed to evaluate

    the long-term safety and efficacy of IV ketamine for psychiatric disorders.

    Although reports of reduction in depression, anxiety, and suicidal ideation are promising, the

    strength of evidence is weak, limited by relatively small sample sizes, loss of effectiveness after 2

    to 7 days, lack of longer-term data on efficacy, limited data on safety, and lack of blinding even

    in double-blind randomized controlled trials. As one expert has noted, it is relatively easy for

    subjects and investigators to distinguish between the effects of ketamine and saline, which is

    used most often as the control agent, or midazolam, which was used as the control agent in a

    recently published study. The midazolam-controlled trial purported to demonstrate a significant

    reduction in suicidal ideation within 24 hours, but was also limited by open-label uncontrolled

    assessment after day 1 for up to 6 weeks, and by the fact that the study population was a cohort

    of psychiatric inpatients; there is no evidence that their experience can be generalized to

    patients in outpatient or other settings. The evidence is therefore insufficient to determine the

    effects of the technology on health outcomes.

    Ongoing and Unpublished Clinical Trials

    Around 100 completed or ongoing trials evaluating intravenous infusion of ketamine for

    depression are listed on clinicaltrials.gov. Most of these studies are phase 1 with fewer than 20

  • Page | 7 of 10 ∞

    patients and many are completed but not published. Some currently ongoing and unpublished

    trials that include over 40 are listed in Table 1.

    Table 1. Summary of Key Trials

    NCT No. Trial Name Planned

    Enrollment

    Completion

    Date

    Ongoing

    NCT02556606 Ketamine for Treatment-Resistant Late-Life Depression 72 Sep 2020

    NCT02461927 Ketamine for The Rapid Treatment of Major Depression

    and Alcohol Use Disorder

    65 Jun 2021

    NCT03666390 A Double-blind, Randomized-controlled Trial Using a Low

    Dose of Ketamine vs Active Placebo in Treating Severe

    Depression and Suicide

    48 Dec 2021

    NCT03674671 Investigations on the Efficacy of Ketamine in Depression in

    Comparison to Electroconvulsive Therapy

    240 Dec 2021

    NCT03113968 ELEKT-D: Electroconvulsive Therapy (ECT) vs Ketamine in

    Patients With Treatment-Resistant Depression (TRD)

    400 Apr 2022

    NCT03237286 Testing a Synergistic, Neuroplasticity-Based Intervention

    for Depressive Neurocognition

    150 Oct 2023

    Unpublished

    NCT01920555 Double-Blind, Placebo-Controlled Trial of Ketamine

    Therapy in Treatment-Resistant Depression (TRD)

    99 Feb 2017

    (completed)

    NCT02299440 Evaluation of the Effects of Ketamine in the Acute Phase of

    Suicidal Ideation: a Multicenter Randomized Double-blind

    Trial

    156 Mar 2019

    (completed)

    NCT02659085 A Randomized Controlled Non-inferiority Trial Comparing

    Ketamine With ECT in Patients With Major Depressive

    Disorder

    200 Dec 2018

    NCT02360280 Intravenous Sub-anesthetic Ketamine Treatment in

    Treatment-Resistant Depression

    62 Mar 2019

    (completed)

    NCT: national clinical trial

    https://clinicaltrials.gov/ct2/show/NCT02556606?term=NCT02556606&draw=1&rank=1https://clinicaltrials.gov/ct2/show/NCT02461927?term=NCT02461927&draw=1&rank=1https://clinicaltrials.gov/ct2/show/NCT03666390?term=NCT03666390&draw=1&rank=1https://clinicaltrials.gov/ct2/show/NCT03674671?term=NCT03674671&draw=1&rank=1https://clinicaltrials.gov/ct2/show/NCT03113968?term=NCT03113968&draw=1&rank=1https://clinicaltrials.gov/ct2/show/NCT03237286?term=NCT03237286&draw=1&rank=1https://www.clinicaltrials.gov/ct2/show/NCT01920555?term=NCT01920555&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02299440?term=NCT02299440&rank=1https://clinicaltrials.gov/ct2/show/NCT02659085?term=NCT02659085&draw=1&rank=1https://clinicaltrials.gov/ct2/show/NCT02360280?term=NCT02360280&draw=1&rank=1

  • Page | 8 of 10 ∞

    Practice Guidelines and Position Statements

    The practice guidelines on managing chronic pain from the American Society of

    Anesthesiologists and the American Society of Regional Anesthesia and Pain Medicine (2010)

    discussed various treatments for chronic pain.15 Use of ionotropic N-methyl-D-aspartate

    receptor antagonists and topical agents for neuropathic pain was addressed; IV infusion of

    lidocaine or ketamine was not.

    The American Psychiatric Association (2017) published an evidence review and consensus

    opinion of the use of ketamine in treatment-resistant depression.16 The Association noted that

    "while ketamine may be beneficial to some patients with mood disorders, it is important to

    consider the limitations of the available data and the potential risk associated with the drug

    when considering the treatment option."

    Medicare National Coverage

    There is no national coverage determination.

    Regulatory Status

    IV lidocaine is approved by the U.S. Food and Drug Administration (FDA) for systemic use in the

    acute treatment of arrhythmias and locally as an anesthetic; IV lidocaine for the treatment of

    chronic pain or psychiatric disorders is an off-label use.

    Ketamine hydrochloride injection is approved for diagnostic and surgical procedures that do not

    require skeletal muscle relaxation, for the induction of anesthesia before the administration of

    other general anesthetic agents, and to supplement low-potency agents, such as nitrous oxide.

    IV ketamine for the treatment of chronic pain or psychiatric disorders is an off-label use.

    References

    1. Wertli MM, Kessels AG, Perez RS, et al. Rational pain management in complex regional pain syndrome 1 (CRPS 1)--a network

    meta-analysis. Pain Med. Sep 2014;15(9):1575-1589. PMID 25234478.

    2. Schwartzman RJ, Alexander GM, Grothusen JR, et al. Outpatient intravenous ketamine for the treatment of complex regional

    pain syndrome: a double-blind placebo controlled study. Pain. Dec 15 2009;147(1-3):107-115. PMID 19783371.

  • Page | 9 of 10 ∞

    3. Sigtermans MJ, van Hilten JJ, Bauer MC, et al. Ketamine produces effective and long-term pain relief in patients with Complex

    Regional Pain Syndrome Type 1. Pain. Oct 2009;145(3):304-311. PMID 19604642.

    4. O'Connell NE, Wand BM, McAuley J, et al. Interventions for treating pain and disability in adults with complex regional pain

    syndrome. Cochrane Database Syst Rev. 2013;4:CD009416. PMID 23633371.

    5. Kim YC, Castaneda AM, Lee CS, et al. Efficacy and safety of lidocaine infusion treatment for neuropathic pain: a randomized,

    double-blind, and placebo-controlled study. Reg Anesth Pain Med. May 2018;43(4):415-424. PMID 29381569.

    6. Liu H, Lu F, Zhou D et al. The Analgesic and Emotional Response to Intravenous Lidocaine Infusion in the Treatment of

    Postherpetic Neuralgia: A Randomized, Double-Blinded, Placebo-controlled Study. Clin J Pain, 2018 Apr 27;34(11). PMID

    29698250.

    7. Moulin DE, Morley-Forster PK, Pirani Z et al. Intravenous lidocaine in the management of chronic peripheral neuropathic pain: a

    randomized-controlled trial. Can J Anaesth, 2019 May 18;66(7). PMID 31098961.

    8. Amr YM. Multi-day low dose ketamine infusion as adjuvant to oral gabapentin in spinal cord injury related chronic pain: a

    prospective, randomized, double blind trial. Pain Physician. May-Jun 2010;13(3):245-249. PMID 20495588.

    9. Patil S, Anitescu M. Efficacy of outpatient ketamine infusions in refractory chronic pain syndromes: a 5-year retrospective

    analysis. Pain Med. Feb 2012;13(2):263-269. PMID 21939497.

    10. Przeklasa-Muszynska A, Kocot-Kepska M, Dobrogowski J, et al. Intravenous lidocaine infusions in a multidirectional model of

    treatment of neuropathic pain patients. Pharmacol Rep. Oct 2016;68(5):1069-1075. PMID 27552062

    11. Noppers I, Niesters M, Swartjes M, et al. Absence of long-term analgesic effect from a short-term S-ketamine infusion on

    fibromyalgia pain: a randomized, prospective, double blind, active placebo-controlled trial. Eur J Pain. Oct 2011;15(9):942-949.

    PMID 21482474

    12. Vlainich R, Issy AM, Sakata RK. Effect of intravenous lidocaine associated with amitriptyline on pain relief and plasma serotonin,

    norepinephrine, and dopamine concentrations in fibromyalgia. Clin J Pain. May 2011;27(4):285-288. PMID 21178598.

    13. Singh JB, Fedgchin M, Daly EJ et al. A Double-Blind, Randomized, Placebo-Controlled, Dose-Frequency Study of Intravenous

    Ketamine in Patients With Treatment-Resistant Depression. Am J Psychiatry, 2016 Apr 9;173(8). PMID 27056608.

    14. Ionescu DF, Bentley KH, Eikermann M et al. Repeat-dose ketamine augmentation for treatment-resistant depression with

    chronic suicidal ideation: A randomized, double blind, placebo controlled trial. J Affect Disord, 2018 Oct 5;243:516-524. PMID

    30286416.

    15. American Society of Anesthesiologists Task Force on Chronic Pain Management, American Society of Regional Anesthesia and

    Pain Medicine. Practice guidelines for chronic pain management: an updated report by the American Society of

    Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain

    Medicine. Anesthesiology. Apr 2010;112(4):810-833. PMID 20124882

    16. Sanacora G, Frye MA, McDonald W, et al. A consensus statement on the use of ketamine in the treatment of mood disorders.

    JAMA Psychiatry. Apr 2017;74(4):399-405. PMID 28249076

    17. Nemeroff C. Ketamine: quo vadis? American Journal of Psychiatry. Apr 2018;175(4):297-299. PMID 29606064

    18. Grunebaum M, Galfalvy H, Choo T, et al. Ketamine for rapid reduction of suicidal thoughts in major depression: a midazolam-

    controlled randomized clinical trial. American Journal of Psychiatry. Apr 2018;175(4):327-335. PMID 29202655

    History

  • Page | 10 of 10 ∞

    Date Comments 08/01/18 New policy, approved July 10, 2018. This policy replaces 5.01.16; Policy title and Policy

    Coverage Criteria amended to include IV ketamine for psychiatric symptoms and

    disorders. References 35-37 added.

    02/01/19 Annual Review, approved January 4, 2019. Policy updated with literature review

    through September 2018; reference 8 added. Policy statement unchanged.

    02/01/20 Annual Review, approved January 9, 2020. Policy updated with literature review

    through October 2019; 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

    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.

  • Discrimination is Against the Law

    LifeWise Health Plan of Washington complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. LifeWise does not exclude people or treat them differently because of race, color, national origin, age, disability or sex.

    LifeWise: • Provides free aids and services to people with disabilities to communicate

    effectively with us, such as: • Qualified sign language interpreters • Written information in other formats (large print, audio, accessible

    electronic formats, other formats) • Provides free language services to people whose primary language is not

    English, such as: • Qualified interpreters • Information written in other languages

    If you need these services, contact the Civil Rights Coordinator.

    If you believe that LifeWise has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator - Complaints and Appeals PO Box 91102, Seattle, WA 98111 Toll free 855-332-6396, Fax 425-918-5592, TTY 800-842-5357 Email [email protected]

    You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue SW, Room 509F, HHH Building Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD) Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

    Getting Help in Other Languages

    This Notice has Important Information. This notice may have important information about your application or coverage through LifeWise Health Plan of Washington. There may be key dates in this notice. You may need to take action by certain deadlines to keep your health coverage or help with costs. You have the right to get this information and help in your language at no cost. Call 800-592-6804 (TTY: 800-842-5357).

    አማሪኛ (Amharic): ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል። ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ LifeWise Health Plan of Washington ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል። በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ። የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል። ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎት።በስልክ ቁጥር 800-592-6804 (TTY: 800-842-5357) ይደውሉ።

    Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa yookan karaa LifeWise Health Plan of Washington 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 800-592-6804 (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 LifeWise Health Plan of Washington. 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 800-592-6804 (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 LifeWise Health Plan of Washington. 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 800-592-6804 (TTY: 800-842-5357).

    Deutsche (German): Diese Benachrichtigung enthält wichtige Informationen. Diese Benachrichtigung enthält unter Umständen wichtige Informationen bezüglich Ihres Antrags auf Krankenversicherungsschutz durch LifeWise Health Plan of Washington. 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 800-592-6804 (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 LifeWise Health Plan of Washington. 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 800-592-6804 (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 LifeWise Health Plan of Washington. Daytoy ket mabalin dagiti importante a petsa iti daytoy

    (Arabic): ةالعربي 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 امةھ ماتولعم اراإلشع ھذا يحوي . أو طلبك وصخصب مةمھ اتمولعم عارشإلا ھذا ويحي قد

    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

    فةلكت أية بدتك دون تكغلب (TTY: 800-842-5357) 6804-592-800بـصل ات .

    中文 (Chinese):本通知有重要的訊息。本通知可能有關於您透過 LifeWise Health Plan of Washington 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 800-592-6804 (TTY: 800-842-5357)。

    037336 (07-2016)

    Italiano (Italian): Questo avviso contiene informazioni importanti. Questo avviso può contenere informazioni importanti sulla tua domanda o copertura attraverso LifeWise Health Plan of Washington. 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 800-592-6804 (TTY: 800-842-5357).

    https://www.hhs.gov/ocr/office/file/index.htmlhttps://ocrportal.hhs.gov/ocr/portal/lobby.jsfmailto:[email protected]

  • 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、 LifeWise Health Plan of Washington 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。 800-592-6804 (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 LifeWise Health Plan of Washington 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 . 800-592-6804 (TTY: 800-842-5357) 로 전화하십시오 .

    ລາວ (Lao): ແຈ້ງການນີ້ ນສໍ າຄັນ. ແຈ້ງການນີ້ ອາດຈະມີ ນສໍ າຄັນກ່ຽວກັບຄໍ າຮ້ອງສະ ກ ຫຼື ຄວາມຄຸ້ມຄອງປະກັນໄພຂອງທ່ານຜ່ານ LifeWise Health Plan of

    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).

    Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через LifeWise Health Plan of Washington. 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 800-592-6804 (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, LifeWise Health Plan of Washington, 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 800-592-6804 (TTY: 800-842-5357).

    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

    រងរបស់អន

    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).

    Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через LifeWise Health Plan of Washington. 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 800-592-6804 (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 LifeWise Health Plan of Washington. 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 800-592-6804 (TTY: 800-842-5357).