7.01.50 Placental and Umbilical Cord Blood as a Source of ... · • For the use of the of stem...

14
MEDICAL POLICY – 7.01.50 Placental and Umbilical Cord Blood as a Source of Stem Cells BCBSA Ref. Policy: 7.01.50 Effective Date: April 1, 2020 Last Revised: March 19, 2020 Replaces: N/A RELATED MEDICAL POLICIES: None 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 Stem cells are cells in our body that have the ability to develop into many different kinds of cells. Stem cells have been used to treat many conditions including such things as diabetes, heart disease, arthritis, spinal cord injuries, and some types of cancer. Stem cells are found in embryos, adults, and the umbilical cords of newborn babies. They are also found in the placenta (the “after birth”) of a pregnant woman. Stem cells that have been retrieved from the placenta or umbilical cord have been transplanted into patients in order to treat some specific diseases. This policy discusses when the transplantation of placental or umbilical cord stem cells might be considered to be medically necessary. 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

Transcript of 7.01.50 Placental and Umbilical Cord Blood as a Source of ... · • For the use of the of stem...

  • MEDICAL POLICY – 7.01.50

    Placental and Umbilical Cord Blood as a Source of Stem

    Cells BCBSA Ref. Policy: 7.01.50

    Effective Date: April 1, 2020

    Last Revised: March 19, 2020

    Replaces: N/A

    RELATED MEDICAL POLICIES:

    None

    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

    Stem cells are cells in our body that have the ability to develop into many different kinds of cells.

    Stem cells have been used to treat many conditions including such things as diabetes, heart

    disease, arthritis, spinal cord injuries, and some types of cancer.

    Stem cells are found in embryos, adults, and the umbilical cords of newborn babies. They are

    also found in the placenta (the “after birth”) of a pregnant woman. Stem cells that have been

    retrieved from the placenta or umbilical cord have been transplanted into patients in order to

    treat some specific diseases. This policy discusses when the transplantation of placental or

    umbilical cord stem cells might be considered to be medically necessary.

    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

  • Page | 2 of 12 ∞

    Service Medical Necessity Transplantation of cord

    blood stem cells

    Transplantation of cord blood stem cells from related or

    unrelated donors may be considered medically necessary in

    patients with an appropriate indication for allogeneic stem cell

    transplant.

    Transplantation of cord blood stem cells from related or

    unrelated donors is considered investigational in all other

    situations.

    Collection and storage of

    cord blood

    Collection and storage of cord blood from a neonate may be

    considered medically necessary when an allogeneic transplant

    is imminent in an identified recipient with a diagnosis that is

    consistent with the possible need for allogeneic transplant.

    Prophylactic collection and

    storage of cord blood

    Prophylactic collection and storage of cord blood from a

    neonate may be considered not medically necessary when

    proposed for some unspecified future use as an autologous

    stem cell transplant in the original donor, or for some

    unspecified future use as an allogeneic stem cell transplant in a

    related or unrelated donor.

    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 the use of the of stem cells retrieved from the umbilical cord and placenta:

    o Documentation that the stem cells will be used in patients who qualify for a stem cell

    transplant using donor cells

    • For collection and storage of cord blood:

    o Documentation that a transplant using donor cells is imminent for a person diagnosed with

    a disease that can be treated by using donor cells

  • Page | 3 of 12 ∞

    Coding

    Code Description

    HCPCS

    S2140 Cord blood harvesting for transplantation, allogeneic

    S2142 Cord blood-derived stem-cell transplantation, allogeneic

    S2150 Bone marrow or blood-derived stem-cells (peripheral or umbilical), allogeneic or

    autologous, harvesting, transplantation, and related complications; including: pheresis

    and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization

    with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative

    services; and the number of days of pre-and post-transplant care in the global

    definition

    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

    Benefit Application

    Through the National Marrow Donor Program’s Be the Match, eligible families within the United

    States can collect and store their neonate’s cord blood unit free of charge. When the stored unit

    is transplanted, a fee is charged. A family is considered eligible if:

    • The sibling of the neonate has been diagnosed with a disease treatable by a related cord

    blood transplant

    • The neonate does not have the same disease as the affected biological sibling (determined

    after birth)

    • The affected sibling and the neonate have the same biological parents

    OR

    • An affected biological parent is enrolled in a clinical or research trial that would accept a

    haploidentical, related, allogeneic cord blood unit as a treatment option

  • Page | 4 of 12 ∞

    Evidence Review

    Description

    This policy addresses the collection, storage, and transplantation of placental and umbilical cord

    blood (“cord blood”) as a source of stem cells for allogeneic and autologous stem cell

    transplantation. Potential indications for the use of cord blood are not addressed in this policy.

    Background

    Hematopoietic Cell Transplantation

    HCT is a procedure in which hematopoietic stem cells are intravenously infused to restore bone

    marrow and immune function in cancer patients who receive bone marrow-toxic doses of

    cytotoxic drugs with or without whole-body radiotherapy. Hematopoietic stem cells may be

    obtained from the transplant recipient (autologous HCT) or a donor (allogeneic HCT [allo-HCT]).

    They can be harvested from bone marrow, peripheral blood, or umbilical cord blood shortly

    after delivery of neonates. Cord blood transplantation is discussed in detail in a separate policy.

    Immunologic compatibility between infused hematopoietic stem cells and the recipient is not an

    issue in autologous HCT. In allogeneic stem cell transplantation, immunologic compatibility

    between donor and patient is a critical factor for achieving a successful outcome. Compatibility

    is established by typing of human leukocyte antigens (HLA) using cellular, serologic, or

    molecular techniques. HLA refers to the gene complex expressed at the HLA-A, -B, and -DR

    (antigen-D related) loci on each arm of chromosome six. An acceptable donor will match the

    patient at all or most of the HLA loci.

    Conditioning for Hematopoietic Cell Transplantation

    Conventional Conditioning

    The conventional (“classical”) practice of allo-HCT involves administration of cytotoxic agents

    (eg, cyclophosphamide, busulfan) with or without total body irradiation at doses sufficient to

    cause bone marrow ablation in the recipient. The beneficial treatment effect of this procedure is

  • Page | 5 of 12 ∞

    due to a combination of the initial eradication of malignant cells and subsequent graft-versus-

    malignancy effect mediated by non-self-immunologic effector cells. While the slower graft-

    versus-malignancy effect is considered the potentially curative component, it may be

    overwhelmed by existing disease in the absence of pretransplant conditioning. Intense

    conditioning regimens are limited to patients who are sufficiently medically fit to tolerate

    substantial adverse effects. These include opportunistic infections secondary to loss of

    endogenous bone marrow function and organ damage or failure caused by cytotoxic drugs.

    Subsequent to graft infusion in allo-HCT, immunosuppressant drugs are required to minimize

    graft rejection and graft-versus-host disease, which increases susceptibility to opportunistic

    infections.

    The success of autologous HCT is predicated on the potential of cytotoxic chemotherapy, with

    or without radiotherapy, to eradicate cancerous cells from the blood and bone marrow. This

    permits subsequent engraftment and repopulation of the bone marrow with presumably normal

    hematopoietic stem cells obtained from the patient before undergoing bone marrow ablation.

    Therefore, autologous HCT is typically performed as consolidation therapy when the patient’s

    disease is in complete remission. Patients who undergo autologous HCT are also susceptible to

    chemotherapy-related toxicities and opportunistic infections before engraftment, but not graft-

    versus-host disease.

    Reduced-Intensity Conditioning Allogeneic Hematopoietic Cell

    Transplantation

    RIC refers to the pretransplant use of lower doses of cytotoxic drugs or less intense regimens of

    radiotherapy than are used in traditional full-dose myeloablative conditioning treatments.

    Although the definition of RIC is variable, with numerous versions employed, all regimens seek

    to balance the competing effects of relapse due to residual disease and non-relapse mortality.

    The goal of RIC is to reduce disease burden and to minimize associated treatment-related

    morbidity and non-relapse mortality in the period during which the beneficial graft-versus-

    malignancy effect of allogeneic transplantation develops. RIC regimens range from nearly total

    myeloablative to minimally myeloablative with lymphoablation, with intensity tailored to specific

    diseases and patient condition. Patients who undergo RIC with allo-HCT initially demonstrate

    donor cell engraftment and bone marrow mixed chimerism. Most will subsequently convert to

    full-donor chimerism. In this review, the term reduced-intensity conditioning will refer to all

    conditioning regimens intended to be nonmyeloablative.

  • Page | 6 of 12 ∞

    Summary of Evidence

    For individuals who have an appropriate indication for allogeneic stem cell transplant who

    receive cord blood as a source of stem cells, the evidence includes a number of observational

    studies, a meta-analysis of observational studies, and a randomized controlled trial (RCT)

    comparing outcomes after single- or double-cord blood units. The relevant outcomes are

    overall survival, disease-specific survival, resource utilization, and treatment-related mortality.

    The meta-analysis of observational studies found similar survival outcomes and lower graft-

    versus-host disease after cord blood transplantation than bone marrow transplantation. In the

    RCT, survival rates were similar after single- and double-unit cord blood transplantation. The

    evidence is sufficient to determine that the technology results in a meaningful improvement in

    the net health outcome.

    For individuals who have an unspecified potential future need for stem cell transplant who

    receive prophylactic collection and storage of cord blood, the evidence includes no published

    studies. The relevant outcomes are overall survival, disease-specific survival, resource utilization,

    and treatment-related mortality. No evidence was identified on the safety or effectiveness of

    autologous cord blood transplantation from prophylactically stored cord blood for the

    treatment of malignant neoplasms. The evidence is insufficient to determine the effects of the

    technology on health outcomes.

    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

    NCT01728545 The Collection and Storage of Umbilical Cord Blood for

    Transplantation

    250,000 Apr 2099

    NCT00012545 Collection and Storage of Umbilical Cord Stem Cells for

    Treatment of Sickle Cell Disease

    99,999,999 Not reported

    NCT: national clinical trial

    https://www.clinicaltrials.gov/ct2/show/NCT01728545?term=NCT01728545&rank=1https://www.clinicaltrials.gov/ct2/show/NCT00012545?term=NCT00012545&rank=1

  • Page | 7 of 12 ∞

    Practice Guidelines and Position Statements

    American Academy of Pediatrics

    A position statement on cord blood banking for potential future transplantation was published

    by the American Academy of Pediatrics in 2017.22 The Academy recommended cord blood

    banking for public use, with a more limited role for private cord blood banking for families with

    a known fatal illness that could be rescued by cord blood transplant.

    American College of Obstetricians and Gynecologists

    The American College of Obstetricians and Gynecologists (2015; updated 2019) published an

    opinion on umbilical cord blood (UCB) banking.24 The statement discussed counseling patients

    about options for UBC banking, as well as benefits and limitations of this practice. The relevant

    recommendations include the following:

    • “[UCB] collected from a neonate cannot be used to treat a genetic disease or malignancy in

    that same individual.”

    • The routine collection and storage of [UCB] with a private cord blood bank is not supported

    by the available evidence.

    • “Private [UCB] banking may be considered when there is knowledge of a family member with

    a medical condition (malignant or genetic) who could potentially benefit from cord blood

    transplantation.”

    • “Public [UCB] banking is the recommended method of obtaining [UBC] for use in

    transplantation, immune therapies, or other medically validated indications.”

    • “Umbilical cord blood collection should not compromise obstetric or neonatal care or alter

    routine practice for the timing of umbilical cord clamping.”

    • “The current indications for cord blood transplant are limited to select genetic, hematologic,

    and malignant disorders.”

    • “If a patient requests information about [UCB] banking, balanced and accurate information

    regarding the advantages and disadvantages of public and private [UCB] banking should be

    provided.”

  • Page | 8 of 12 ∞

    American Society for Blood and Marrow Transplantation

    On behalf of the American Society for Blood and Marrow Transplantation, Ballen et al (2008)

    published recommendations related to the banking of umbilical cord blood25.

    • Public banking of cord blood is “encouraged.”

    • Storing cord blood for autologous (ie, personal) use is “not recommended.”

    • “Family member banking (collecting and storing cord blood for a family member) is

    recommended when there is a sibling with a disease that may be successfully treated with an

    allogeneic transplant. Family member banking on behalf of a parent with a disease that may

    be successfully treated with an allogeneic transplant is only recommended when there are

    shared HLA [human leukocyte-antigens] between the parents.”

    Medicare National Coverage

    There is no national coverage determination.

    Regulatory Status

    According to the U.S. Food and Drug Administration, cord blood stored for potential use by a

    patient unrelated to the donor meets the definitions of “drug” and “biological products.” As

    such, products must be licensed under a biologics license application or an investigational new

    drug application before use. Facilities that prepare cord blood units only for autologous and/or

    first- or second-degree relatives are required to register and list their products, adhere to Good

    Tissue Practices issued by the Food and Drug Administration, and use applicable processes for

    donor suitability determination.1

    References

    1. Food and Drug Administration (FDA). Cord Blood Banking: Information for Consumers. 2012 July 23;

    http://www.fda.gov/biologicsbloodvaccines/resourcesforyou/consumers/ucm236044.htm Accessed March 2020.

    2. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Placental and Umbilical Cord Blood as a Source of

    Stem Cells for Hematopoietic Support. TEC Assessments. 1996;Volume 11:Tab 17.

    http://www.fda.gov/biologicsbloodvaccines/resourcesforyou/consumers/ucm236044.htm

  • Page | 9 of 12 ∞

    3. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Transplanting Adult Patients with Hematopoietic

    Stem Cells from Placental and Umbilical Cord Blood TEC Assessments. 2001;Volume 16:Tab 17.

    4. Wall DA. Regulatory issues in cord blood banking and transplantation. Best Pract Res Clin Haematol. Jun 2010;23(2):171-177.

    PMID 20837328

    5. NetCord-FACT. International standards for cord blood collection banking and release of information accreditation manual. Sixth

    Edition Draft. 2015 September;

    http://www.factwebsite.org/uploadedFiles/Standards/NetCord%20FACT%206th%20Ed%20Manual%20Draft.09.01.15.p

    df Accessed March 2020.

    6. Gluckman E, Broxmeyer HA, Auerbach AD, et al. Hematopoietic reconstitution in a patient with Fanconi's anemia by means of

    umbilical-cord blood from an HLA-identical sibling. N Engl J Med. Oct 26 1989;321(17):1174-1178. PMID 2571931

    7. Wagner JE, Rosenthal J, Sweetman R, et al. Successful transplantation of HLA-matched and HLA-mismatched umbilical cord

    blood from unrelated donors: analysis of engraftment and acute graft-versus-host disease. Blood. Aug 1 1996;88(3):795-802.

    PMID 8704232

    8. Broxmeyer HE, Douglas GW, Hangoc G, et al. Human umbilical cord blood as a potential source of transplantable

    hematopoietic stem/progenitor cells. Proc Natl Acad Sci U S A. May 1989;86(10):3828-3832. PMID 2566997

    9. Kurtzberg J, Cairo MS, Fraser JK, et al. Results of the Cord Blood Transplantation (COBLT) study unrelated donor banking

    program. Transfusion. Jun 2005;45(6):842-855. PMID 15934981

    10. Martin PL, Carter SL, Kernan NA, et al. Results of the Cord Blood Transplantation Study (COBLT): outcomes of unrelated donor

    umbilical cord blood transplantation in pediatric patients with lysosomal and peroxisomal storage diseases. Biol Blood Marrow

    Transplant. Feb 2006;12(2):184-194. PMID 16443516

    11. Kurtzberg J. Update on umbilical cord blood transplantation. Curr Opin Pediatr. Feb 2009;21(1):22-29. PMID 19253461

    12. Zhang H, Chen J, Que W. Meta-analysis of unrelated donor umbilical cord blood transplantation versus unrelated donor bone

    marrow transplantation in acute leukemia patients. Biol Blood Marrow Transplant. Aug 2012;18(8):1164-1173. PMID 22289799

    13. Rocha V, Cornish J, Sievers EL, et al. Comparison of outcomes of unrelated bone marrow and umbilical cord blood transplants in

    children with acute leukemia. Blood. May 15 2001;97(10):2962-2971. PMID 11342418

    14. Kato K, Choi I, Wake A, et al. Treatment of patients with adult T cell leukemia/lymphoma with cord blood transplantation: a

    Japanese nationwide retrospective survey. Biol Blood Marrow Transplant. Dec 2014;20(12):1968-1974. PMID 25172635

    15. Liu HL, Sun ZM, Geng LQ, et al. Similar survival, but better quality of life after myeloablative transplantation using unrelated

    cord blood vs matched sibling donors in adults with hematologic malignancies. Bone Marrow Transplant. Aug 2014;49(8):1063-

    1069. PMID 24842525

    16. Mo XD, Tang BL, Zhang XH, et al. Comparison of outcomes after umbilical cord blood and unmanipulated haploidentical

    hematopoietic stem cell transplantation in children with high-risk acute lymphoblastic leukemia. Int J Cancer. Nov 1

    2016;139(9):2106-2115. PMID 27356906

    17. Hsu J, Artz A, Mayer SA, et al. Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation for

    High-Risk Lymphoma and Chronic Lymphoblastic Leukemia. Biol Blood Marrow Transplant. Feb 2018;24(2):359-365. PMID

    29128555

    18. Barker JN, Weisdorf DJ, DeFor TE, et al. Transplantation of 2 partially HLA-matched umbilical cord blood units to enhance

    engraftment in adults with hematologic malignancy. Blood. Feb 1 2005;105(3):1343-1347. PMID 15466923

    19. Wagner JE, Jr., Eapen M, Carter S, et al. One-unit versus two-unit cord-blood transplantation for hematologic cancers. N Engl J

    Med. Oct 30 2014;371(18):1685-1694. PMID 25354103

    20. Scaradavou A, Brunstein CG, Eapen M, et al. Double unit grafts successfully extend the application of umbilical cord blood

    transplantation in adults with acute leukemia. Blood. Jan 31 2013;121(5):752-758. PMID 23223509

    http://www.factwebsite.org/uploadedFiles/Standards/NetCord%20FACT%206th%20Ed%20Manual%20Draft.09.01.15.pdfhttp://www.factwebsite.org/uploadedFiles/Standards/NetCord%20FACT%206th%20Ed%20Manual%20Draft.09.01.15.pdf

  • Page | 10 of 12 ∞

    21. Baron F, Ruggeri A, Beohou E, et al. Single- or double-unit UCBT following RIC in adults with AL: a report from Eurocord, the

    ALWP and the CTIWP of the EBMT. J Hematol Oncol. Jun 21 2017;10(1):128. PMID 28637512

    22. Shearer WT, Lubin BH, Cairo MS, et al. Cord Blood Banking for Potential Future Transplantation. Pediatrics. Nov 2017;140(5).

    PMID 29084832

    23. Thornley I, Eapen M, Sung L, et al. Private cord blood banking: experiences and views of pediatric hematopoietic cell

    transplantation physicians. Pediatrics. Mar 2009;123(3):1011-1017. PMID 19255033

    24. ACOG committee opinion no. 771: umbilical cord banking. Obstet Gynecol. 2019 Mar;133(3):e249e253. PMID: 30801478.

    25. Ballen KK, Barker JN, Stewart SK, et al. Collection and preservation of cord blood for personal use. Biol Blood Marrow

    Transplant. Mar 2008;14(3):356-363. PMID 18275904

    History

    Date Comments 05/05/97 Add to Surgery Section - New Policy

    04/09/02 Replace policy - Policy updated and revised based on 2001 TEC Assessment; cord

    blood as a source of stem cells no longer restricted to children, considered medically

    necessary in adults.

    09/12/03 Replace policy - Policy updated; statement added about storing cord blood stem cells

    for later possible use as autologous transplant.

    06/09/06 Disclaimer and Scope update - No other changes.

    12/11/07 Replace policy - Reviewed with literature search; no change to policy statement;

    references added. Reviewed and recommended by OAP on November 15, 2007.

    05/13/08 Cross Reference Update - No other changes

    12/08/09 Replace policy - Reviewed with literature search; no change to policy statement;

    Reviewed by OAP November 2009. Benefit Application language regarding storage

    added.

    08/10/10 Replace policy - Policy updated with literature review and extensive revisions.

    References 1, 2 and 5-19 have been added. The intent of the policy statements has not

    changed.

    11/10/11 Replace policy – Policy updated with literature review; policy statement unchanged.

    References 3 and 4 added. Related Policies updated.

    01/25/12 Code 38232 added.

    09/10/12 Update Related Policy – Remove 7.01.503 as it was deleted; Add 8.01.21 and 8.01.22.

    ICD-10 codes are now effective 10/01/2014.

    10/01/12 Update Related Policies – Add 8.01.20, 8.01.29, 8.01.23, 8.01.27, 8.01.28, 8.01.30.

  • Page | 11 of 12 ∞

    Date Comments 10/26/12 Update Related Policies. Add 8.01.26.

    12/19/12 Replace policy. Policy updated with literature review; policy statements unchanged.

    References 5, 9-11 added. Add Related Policies 8.01.24, 8.01.31 and 8.01.35.

    02/01/13 Update Related Policies, change title of policy 8.01.21.

    02/15/13 Update Related Policies, change title of policy 8.01.30.

    07/25/13 Update Related Policies. Change title of policy 8.01.35, add 8.01.511.

    09/30/13 Update Related Policies. Change title of policy 8.01.31.

    12/04/13 Replace policy. Rationale updated based on a literature review through July 25, 2013.

    References 4, 5, 19, 20, 26, 29, 30 added; others renumbered or removed. Policy

    statements unchanged.

    01/20/14 Update Related Policies. Change title to 8.01.21.

    02/27/14 Update Related Policies. Change title to 8.01.30.

    03/21/14 Update Related Policies. Add 8.01.15 and delete 8.01.514.

    04/18/14 Update Related Policies. Delete 8.01.20 and add 8.01.529.

    06/24/14 Update Related Policies. Delete 8.01.35, 8.01.42 and 8.01.54, then add 8.01.530,

    8.01.531 and 8.01.532.

    11/20/14 Annual Review. Policy updated with literature review through July 21, 2014. Policy

    statements unchanged. References 4, 16-17, and 23 added. ICD-9 and ICD-10

    procedure codes removed; these are not utilized in adjudication of the policy.

    11/10/15 Annual Review. Policy updated with literature review through August 10, 2015;

    reference 23 added. Policy statements unchanged.

    03/08/16 Annual Review. Policy updated with literature review through December 6, 2015;

    reference 27 added. Policy statements unchanged.

    08/09/16 Update Related Policies. Remove 8.01.27 as it was archived.

    03/14/17 Annual review. Policy updated with literature review through November 9, 2016;

    references 17 and 23 added. Removed Related Policies. Removed CPT codes 38232

    and 38240. Policy statements unchanged.

    10/27/17 Policy moved to new format; no change to policy statements.

    04/01/18 Annual Review, approved March 20, 2018. Policy updated with literature review

    through November 2017; references 20-21 added; note 2 updated. Policy statements

    unchanged.

    08/01/19 Annual Review, approved July 25, 2019. Policy updated with literature review through

    November 2018; reference 17 added. Policy statements unchanged.

    04/01/20 Annual Review, approved March 19, 2020. Policy updated with literature review

    through November 2019; no references added. Policy statements unchanged.

  • Page | 12 of 12 ∞

    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

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

    Premera: • 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 Premera 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 855-332-4535, 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 Premera Blue Cross. 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 800-722-1471 (TTY: 800-842-5357).

    አማሪኛ (Amharic): ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል። ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross 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 800-722-1471 (TTY: 800-842-5357) ይደውሉ።

    ( ةالعربي :(. امةھ ماتولعم اإلشعار ھذا يحوي

    خالل من ھاعلي صولحلا تريد لتيا التغطيةلل أو ةصحيلاكطيتتغ لىع اظلحفل نةعيم يخراوت في إجراء خاذتال تحتاج وقد .اإلشعار ھذا في

    تكلفة أية بدتك دون بلغتك مساعدةوال تاوملالمع ھذه على ولحصال لك يحق .800-722-1471 (TTY: 800-842-5357)

    أو طلبك وصخصب مةمھ ماتوعلم عارشإلا ھذا ويحي قدةمھم يخراوت ھناك تكون قد .Premera Blue Cross

    اعدةمس تصلايفكالتال دفع فيبـ

    .

    Arabic

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

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

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

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

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

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

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

    Italian

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

    之前採取行動,以保留您的健康保險或者費用補貼。您有權利免費以您的母

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

    037338 (07-2016)

    https://www.hhs.gov/ocr/office/file/index.htmlhttps://ocrportal.hhs.gov/ocr/portal/lobby.jsfmailto:[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、 Premera Blue Crossの申請または補償範囲に関する重要な情報が含まれている場合があります。この通知に記載されている可能性がある重要な日付をご確認くだ

    さい。健康保険や有料サポートを維持するには、特定の期日までに行動を

    取らなければならない場合があります。ご希望の言語による情報とサポー

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

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

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

    ູຂໍ້

    ສໍ ັ

    ສິ

    ມູຮັ

    ູມີ ມຂໍ້

    ភាសាែខមរ ( ): ឹ

    រងរបស់

    Premera Blue Cross ។ របែហលជាមាន កាលបរ ិ ឆ ំខានេនៅកងេសចក

    េសចកតជី ូ

    ជាមានព័ ៌ ៉ ងសំ ់អពី ់ ៉ ប់

    នដំ ងេនះមានព័ ី

    តមានយា ខាន ំ ទរមងែបបបទ ឬការរា

    ណ ត៌មានយ៉ា ំ ់ តងសខាន។ េសចក

    េចទស ់ ន ុ ត

    ណងេនះ។ អ វការបេញញសមតភាព ដលកណតៃថ ចបាស

    កតាមរយៈ

    ដំ ឹ នករបែហលជារតូ ច ថ ់ ំ ់ ងជាក់ ់

    នដ

    ី ន

    ំណឹងេនះរបែហល

    នានា េដើ ីនងរកសាទុ ៉ បរងស់ ុ ់ ក ឬរបាក់ ំ

    មប ឹ កការធានារា ខភាពរបស ជ

    ធនកមានសិ ទទលព័ មានេនះ និ ំ យេនៅកុងភាសារបសទិ ួ ត៌ ងជ ននួ

    ់ កេដាយម

    នអ

    យេចញៃថល។ ួ

    នអស

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

    Khmer

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

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

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

    ੇ ੇ ੇ ੱ ੂ ੋ ੈ ੋੋ ਂ ੁ ੇ ੱ ੋ ੇ ੱੱ ੁ ੱ ੂੁ ੱ ੇ ੱ ੇ ੍ਰ ੈ

    ੋ ੰ ੂ ੱ ੁ ੋ ੋ ੈ ੰ

    ੋ ੈ ੋ

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Spanish

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

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

    ้ี ี ้ ู ํ ั ้ี ี ้ ู ่ี ํ ั ่ี ั ั ื ัุ ุ ่ ี ํ ี ุ ้ํ ิ ํ ่ี ่ ่ื ั ั ุ ุ ื ่ ื ่ีี ่ ้ ่ ุ ี ิ ิ ่ี ้ ั ้ ู ่ ื ้ี ุ ี ่ ้ ่

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

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