Subject:
Axicabtagene Ciloleucel (Yescarta)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkins lymphoma (NHL) in adults. Approximately 72,000 new cases of NHL are diagnosed in the U.S. each year, and DLBCL represents approximately one in three newly diagnosed cases. In general, when patients are treated with standard care and the disease becomes refractory, medial overall survival lessens to approximately six months. Moreover, patients with large B-cell lymphoma that do not respond or relapse have poor outcomes and greater unmet need.
In October 2017, FDA approved YescartaTM (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. As a limitation of use, Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. Yescarta is the second gene therapy available in the United States, continuing the availability and trend of a new approach to the treatment of cancer and other serious and life-threatening diseases.
Yescarta (axicabtagene ciloleucel) suspension for intravenous infusion is a CD-19 directed genetically modified autologous T cell immunotherapy. Each dose of Yescarta is a customized treatment created using an individual patient’s own immune system to help fight the lymphoma. The patient’s T-cells, a type of white blood cell known as lymphocyte, are collected and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells to target and kill leukemia cells that have a specific antigen (CD19) on the surface. Once the cells are modified, they are infused back into the patient to kill the cancer cells.
The safety and efficacy of a single infusion of Yescarta in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma was evaluated in a single-arm, open-label, multicenter trial. Of 111 patients who underwent leukapheresis, 101 received Yescarta. All patients were hospitalized for Yescarta infusion and for a minimum of 7 days afterward. Following lymphodepleting chemotherapy, Yescarta was administered as a single intravenous infusion at a target dose of 2 × 106 CAR-positive viable T cells/kg; the maximum permitted dose was 2 × 108 cells. The lymphodepleting regimen consisted of cyclophosphamide 500 mg/m2 intravenously and fludarabine 30 mg/m2 intravenously, both given on the third, fourth and fifth day prior to Yescarta. Bridging chemotherapy between leukapheresis and lymphodepleting chemotherapy was not permitted. Of the 101 patients evaluated for efficacy, the objective response rate (ORR) as assessed by independent central review was 72%, with a complete remission (CR) rate of 51% (95% CI: 41, 62). At a median follow-up of 7.9 months, patients who had achieved a complete remission had not reached the estimated median duration of response (95% CI: 8.1 months, not estimable [NE]). The median time to response was 0.9 months (range: 0.8 to 6.2 months).
Yescarta has a black boxed warning for cytokine release syndrome and neurological toxicities. Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving Yescarta. Do not administer Yescarta to patients with active infection or inflammatory disorders. Patients should be treated for severe or life-threatening CRS with tocilizumab with or without corticosteroids. Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving Yescarta, including concurrently with CRS or after CRS resolution. Patients should be monitored for neurologic toxicities after treatment with Yescarta. Supportive care should be provided, including the use of corticosteroids when necessary. To mitigate CRS and neurologic toxicities, Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA REMS.
Warning and precautions for Yescarta include: cytokine release syndrome; neurological toxicities; hypersensitivity reactions; serious infections; prolonged cytopenias; hypogammaglobulinemia; secondary malignancies; and effects on ability to drive and use machines. The most common adverse reactions (incidence greater than 20%) are cytokine release syndrome, fever, tachycardia, decreased appetite, encephalopathy, hypotension, headache, arrhythmia, diarrhea, nausea, vomiting, constipation, fatigue, chills, infections, tremor, dizziness, hypoxia, and cough.
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
1. Axicabtagene ciloleucel (Yescarta) is medically necessary based on the FDA approved indication for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy that meet ALL of the following:
· Member has large B-cell lymphoma defined as ONE of the following:
a. Diffuse large B-cell lymphoma (DLBCL) not otherwise specified
b. Primary mediastinal large B-cell lymphoma (PMBCL)
c. High grade B-cell lymphoma
d. DLBCL arising from follicular lymphoma.
· Chemotherapy-refractory disease, defined as ONE of the following:
a. No response to last line of therapy defined as either
§ Progressive disease as best response to most recent therapy regimen
§ Stable disease as best response to most recent therapy with duration no longer than 6 months from the last dose of therapy
b. Refractory post-autologous stem cell transplantation (ASCT) defined as either
§ Disease progression or relapse <12 months of ASCT
§ If salvage therapy is given post-ASCT, member did not have response to or relapsed after the last line of therapy
- Members must have received two or more prior lines of systemic therapy with both of the following:
a. an anthracycline containing chemotherapy regimen
b. anti-CD20 monoclonal antibody, unless tumor is CD-20 negative
- For members with transformed follicular lymphoma, member must have received prior chemotherapy for follicular lymphoma and subsequently have chemotherapy refractory disease after transformation to DLBCL
- Member does not have primary central nervous system lymphoma
· Member aged 18 and older years
· Eastern cooperative oncology group (ECOG) performance status of 0 or 1
· Member does not have history of allogeneic stem cell transplantation
· Member has not received CAR therapy
· Member does not have active, uncontrolled systemic infection or inflammatory disorders
· Member has been screened for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.
· Yescarta will be used as single agent therapy (not applicable to lymphodepleting or bridging chemotherapy)
· Requirements of the YESCARTA REMS Program have been met:
a. Healthcare facility that dispense and administer drug must be enrolled and comply with the REMS requirements. Certified healthcare facility must have on-site, immediate access to tocilizumab and ensure that a minimum of two doses of tocilizumab are available for each patient for administration within 2 hours after Yescarta infusion, if needed for treatment of CRS.
b. Certified healthcare facility must ensure that healthcare providers who prescribe, dispense, or administer Yescarta are trained about the management of CRS and neurological toxicities.
· Vaccination with live vaccines will not to be administered for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Yescarta treatment, and until immune recovery following treatment with Yescarta.
· Member will refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for 8 weeks after drug administration.
- The prescriber is a specialist in the area of the patient’s diagnosis (e.g. oncologist) or has consulted with a specialist in the area of the patient’s diagnosis
[INFORMATIONAL NOTE: The CD19 antigen is a pan-B cell marker that can be expressed on the surface of leukemia cells in patients with ALL and NHL, which makes it an immunotherapy target for anti-CD19 treatment. Anti-CD19 therapy targets the CD19 antigen on the surface of B cells and B-cell tumors and causes lysis of the CD19 cell.]
2. When axicabtagene ciloleucel (Yescarta) is considered medically necessary, initial therapy will be approved once per lifetime based on FDA-approved labeling:
a. One treatment course consists of fludarabine and cyclophosphamide lymphodepleting chemotherapy followed by intravenous infusion of Yescarta
b. Yescarta is administered as a single-dose unit containing chimeric antigen receptor (CAR)-positive viable T cells based on the patient weight reported at the time of leukapheresis, with a target dose of 2 × 106 CAR-positive viable T cells/kg. The maximum dose is 2 × 108 cells CAR-positive viable T cells/kg
c. Yescarta is administered 3 days after completion of the lymphodepleting chemotherapy
d. Lymphodepleting chemotherapy is administered on the fifth, fourth and third day prior to infusion of Yescarta, which consists of both of the following:
i. Fludarabine 30 mg/m2 intravenous daily AND
ii. Cyclophosphamide 500 mg/m2 intravenous daily
e. After administration of Yescarta, signs and symptoms of Cytokine Release Syndrome (CRS) and other neurological toxicities should be monitored and supportive care should be provided as appropriate.
f. Yescarta will be approved for 60 days duration. A maximum of one dose per lifetime will apply.
[INFORMATIONAL NOTE: Based on the FDA approved prescribing information, the following is stated in regards to dosing and administration of axicabtagene ciloleucel (Yescarta):
Preparation for Infusion:
1. Ensure tocilizumab and emergency equipment are available prior to infusion and during the recovery period.
2. Pre-medicate patient with acetaminophen 650 mg PO and diphenhydramine 12.5 mg intravenously or PO approximately 1 hour prior to Yescarta infusion. Prophylactic use of systemic corticosteroids should be avoided, as it may interfere with the activity of Yescarta.
Based on FDA prescribing information, cytokine release syndrome (CRS) should be identified based on clinical presentation. If CRS is suspected, manage according to the recommendations in Table 1. Patients who experience Grade 2 or higher CRS (e.g., hypotension, not responsive to fluids, or hypoxia requiring supplemental oxygenation) should be monitored with continuous cardiac telemetry and pulse oximetry. For patients experiencing severe CRS, consider performing an echocardiogram to assess cardiac function. For severe or life-threatening CRS, consider intensive care supportive therapy.]
| Table 1. CRS Grading and Management Guidance |
| CRS Grade | Tocilizumab | Corticosteroids |
Grade 1
Symptoms require symptomatic treatment only (e.g., fever, nausea, fatigue, headache, myalgia, malaise). | N/A | N/A |
Grade 2
Symptoms require and respond to moderate intervention.
Oxygen requirement less than 40% FiO2 or hypotension responsive to fluids or low-dose of one vasopressor or
Grade 2 organ toxicity | Administer tocilizumab 8 mg/kg intravenously over 1 hour (not to exceed 800 mg).
Repeat tocilizumab every 8 hours as needed if not responsive to intravenous fluids or increasing supplemental oxygen.
Limit to a maximum of 3 doses in a 24- hour period; maximum total of 4 doses. | Manage per Grade 3 if no improvement within 24 hours after starting tocilizumab. |
Grade 3
Symptoms require and respond to aggressive intervention.
Oxygen requirement greater than or equal to 40% FiO2 or hypotension requiring high-dose or multiple vasopressors or
Grade 3 organ toxicity or Grade 4 transaminitis | Per Grade 2 | Administer methylprednisolone 1 mg/kg intravenously twice daily or equivalent dexamethasone (e.g., 10 mg intravenously every 6 hours).
Continue corticosteroids use until the event is Grade 1 or less, then taper over 3 days. |
Grade 4
Life-threatening symptoms.
Requirements for ventilator support, continuous veno-venous hemodialysis (CVVHD) or
Grade 4 organ toxicity (excluding transaminitis). | Per Grade 2 | Administer methylprednisolone 1000 mg intravenously per day for 3 days; if improves, then manage as above. |
Based on FDA prescribing information, signs and symptoms of neurologic toxicities should be monitored, according to Table 2. Other causes of neurologic symptoms should be ruled out. Patients who experience Grade 2 or higher neurologic toxicities should be monitored with continuous cardiac telemetry and pulse oximetry. Intensive care supportive therapy for severe or life threatening neurologic toxicities should be provided. Non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis for any Grade 2 or higher neurologic toxicities should be considered.
| Table 2. Neurologic Toxicity Grading and Management Guidance |
| Grading Assessment | Concurrent CRS | No concurrent CRS |
| Grade 2 | Administer tocilizumab per Table 1 for management of Grade 2 CRS.
If no improvement within 24 hours after starting tocilizumab, administer dexamethasone 10 mg intravenously every 6 hours if not already taking other corticosteroids. Continue dexamethasone use until the event is Grade 1 or less, then taper over 3 days. | Administer dexamethasone 10 mg intravenously every 6 hours.
Continue dexamethasone use until the event is Grade 1 or less, then taper over 3 days. |
| Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis |
| Grade 3 | Administer tocilizumab per Table 1 for management of Grade 2 CRS.
In addition, administer dexamethasone 10 mg intravenously with the first dose of tocilizumab and repeat dose every 6 hours. Continue dexamethasone use until the event is Grade 1 or less, then taper over 3 days. | Administer dexamethasone 10 mg intravenously every 6 hours.
Continue dexamethasone use until the event is Grade 1 or less, then taper over 3 days. |
| Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis. |
| Grade 4 | Administer tocilizumab per Table 1 for management of Grade 2 CRS.
Administer methylprednisolone 1000 mg intravenously per day with first dose of tocilizumab and continue methylprednisolone 1000 mg intravenously per day for 2 more days; if improves, then manage as above. | Administer methylprednisolone 1000 mg intravenously per day for 3 days; if improves, then manage as above. |
| Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis. |
3. Axicabtagene Ciloleucel (Yescarta) is medically necessary for the following off-label uses:
- Treatment for relapsed AIDS-related diffuse large B-cell lymphoma and HHV8-positive diffuse large B-cell lymphoma, not otherwise specific (NOS) as
- additional therapy for patients with intention to proceed to transplant who have partial response following second-line therapy for relapsed or refractory disease
- treatment (if not previously given) of disease in second relapse or greater in patients with partial response, no response, or progressive disease following therapy for relapsed or refractory disease
- Treatment for monomorphic Post-Transplant Lymphoproliferative Disorders (PTLD )(B-cell type) as
- additional therapy for patients with intention to proceed to transplant who have partial response following second-line chemoimmunotherapy for relapsed or refractory disease
- treatment of disease in second relapse or greater (if not previously given)
- Treatment for for high-grade B-cell lymphomas with translocations of MYC and BCL2 and/or BCL6 (double/triple hit lymphoma) or high-grade B-cell lymphomas, not otherwise specified as
- Additional therapy for patients with intention to proceed to transplant who have partial response following second-line therapy for relapsed or refractory disease
- Treatment (if tisagenlecleucel or axicabtagene ciloleucel was not previously given) of disease in second relapse or greater in patients with partial response, no response, or progressive disease following therapy for relapsed or refractory disease
- Treatment of histologic transformation to diffuse large B-cell lymphoma (DLBCL) in patients who have received
- Minimal or no chemotherapy prior to histologic transformation to DLBCL and have partial response, no response, or progressive disease after treatment with ≥2 chemoimmunotherapy regimens which included at least one anthracycline or anthracenedione-based regimen, unless contraindicated
- Multiple lines of prior therapies (not including axicabtagene ciloleucel or tisagenlecleucel) for indolent or transformed disease (only after treatment with ≥2 chemoimmunotherapy regimens which included at least one anthracycline or anthracenedione-based regimen, unless contraindicated)
- Used for diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma as
- Additional therapy for patients with intention to proceed to transplant who have partial response following second-line therapy for relapsed or refractory disease
- Treatment (if tisagenlecleucel or axicabtagene ciloleucel was not previously given) of disease in second relapse or greater in patients with partial response, no response, or progressive disease following therapy for relapsed or refractory disease
4. All other uses of axicabtagene ciloleucel (Yescarta ) are considered investigational, including but not limited to: use as first-line therapy for B-cell lymphoma, relapsed/refractory mantle cell lymphoma, multiple myeloma, chronic Lymphocytic Leukemia (CLL), small Lymphocytic Lymphoma (SLL), splenic marginal zone lymphoma, mantle cell lymphoma.
Medicare Coverage:
Per Final Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N) issued 8/09/19, autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) is covered when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) and used for a medically accepted indication as defined at Social Security Act section 1861(t)(2) i.e., is used for either an FDA-approved indication (according to the FDA-approved label for that product), or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia. For additional information and eligibility, refer to Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N). Available at: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx
Medicare Advantage Products differs from the Horizon BCBS policy regarding CPT codes 0537T, 0538T, and 0539T. Per MLN Matters Number: SE19009 Chimeric Antigen Receptor (CAR) T-Cell Therapy and CMS status indicator rules, CPT codes 0537T, 0538T, and 0539T are not eligible for separate payable.
Centers for Medicare & Medicaid Services (CMS) MLN SE 19009 Chimeric Antigen Receptor (CAR) T-Cell Therapy Revenue Code and HCPCS Setup Revisions May 28, 2019. Available at: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE19009.pdf
Note: For Calendar Years (CYs) 2019 and 2020 only, original fee-for-service Medicare will pay for CAR T-cell therapy when Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N) criteria is met. Therefore, providers must submit all claims for CAR-T Cell Therapy and associated costs to the local MAC. Claims should not be submitted to the Medicare Advantage plan.
Medicaid Coverage:
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Axicabtagene Ciloleucel (Yescarta)
Yescarta (Axicabtagene Ciloleucel)
References:
1. Yescarta™ [Package Insert]. Santa Monica, CA: Kite Pharma, Inc. May 2019.
2. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. B-Cell Lymphomas. Version 6.2019. November 26, 2019. Accessed December 2019.
3. FDA Approved Vaccines, Blood & Biologics. YESCARTA. Available at: https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm581222.htm. Accessed October 2017.
4. FDA Press Release. FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma. Available at: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm581216.htm. Accessed October 2017.
5. Micromedex® Healthcare Series. n.d. Thomson Healthcare, Greenwood Village, CO. December 2019. http://www.thomsonhc.com.
6. Locke F.L. Primary results from ZUMA-1: a pivotal trial of axicabtagene ciloleucel (axicel; KTE-C19) in patients with refractory aggressive non-Hodgkin lymphoma (NHL) [Presentation]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; 2017. Abstract nr [CT019].
7. ClinicalTrials.gov. A Phase 1-2 Multi-Center Study Evaluating KTE-C19 in Subjects With Refractory Aggressive Non-Hodgkin Lymphoma (ZUMA-1) (ZUMA-1). March 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT02348216. Accessed October 2017.
8. Axicabtagene Ciloleucel. Yescarta. Nccn.Org, 2019, https://www.nccn.org/professionals/drug_compendium/content/. Accessed 17 Dec 2019.
9. Wang, Kemeng et al. “CD19: a biomarker for B cell development, lymphoma diagnosis and therapy” Experimental hematology & oncology vol. 1,1 36. 29 Nov. 2012, doi:10.1186/2162-3619-1-36
10. Raufi, Ali et al. “Targeting CD19 in B-cell lymphoma: emerging role of SAR3419” Cancer management and research vol. 5 225-33. 27 Aug. 2013, doi:10.2147/CMAR.S45957
11. Abramson JS, Palomba ML, Gordon LI, et al. High CR rates in relapsed/refractory (R/R) aggressive B-NHL treated with the CD19-directed CAR T cell product JCAR017 (TRANSCEND NHL 001). Presented at: 14th International Conference on Malignant Lymphoma; June 14-17, 2017; Lugano, Switzerland. Abstract 128.
12. Cruz CRY, Micklethwaite KP, Savoldo B, et al. Infusion of donor-derived CD19-redirected virus-specific T cells for B-cell malignancies relapsed after allogeneic stem cell transplant: a phase 1 study. Blood 2013;122(17):2965-2973.
13. Kochenderfer JN, Dudley ME, Carpenter RO, et al. Donor-derived CD19-targeted T cells cause regression of malignancy persisting after allogeneic hematopoietic stem cell transplantation. Blood 013;122(25):4129-4139.OpenUrlCrossRefPubMedGoogle Scholar.
14. Brudno JN, Somerville RP, Shi V, et al. Allogeneic T cells that express an anti-CD19 chimeric antigen receptor induce remissions of B-cell malignancies that progress after allogeneic hematopoietic stem-cell transplantation without causing graft-versus-host disease. J Clin Oncol 2016;34(10):1112-1121.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
0537T
0538T
0539T
0540T
HCPCS
Q2041
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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