Subject:
Natalizumab (Tysabri)
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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[Please refer to a separate policies on Drug Therapy for Multiple Sclerosis (Policy #038) under the Drugs Section of this database.]
Natalizumab (Tysabri), a monoclonal antibody, was FDA approved for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. It was voluntarily withdrawn from the market in February 2005 due to reports of progressive multifocal leukoencephalopathy (PML). In June 2006, Tysabri was reintroduced in the US market. In January 2008, natalizumab was FDA approved for the induction and maintenance of moderate-to-severe Crohn’s disease. Since there is risk for PML, the drug is only available through a special restricted distribution program called the TOUCH Prescribing Program. For prescribers and patients, the TOUCH Prescribing Program has two components: MS TOUCH and CD TOUCH. Under this program, only prescribers, infusion centers, and pharmacies associated with infusion centers registered with the program are able to prescribe, distribute, or infuse the drug. Tysabri is to be administered to patients who are enrolled in and meet all of the conditions of the TOUCH Prescribing Program as per the FDA-approved product labeling.
A total of seven cases of PML were observed during clinical trials and in the post-marketing setting. Originally, three patients developed PML during clinical trials, with two cases observed among 1,869 patients with MS treated for 120 weeks, while the third case occurred among 1043 patients with CD, after receiving 8 doses of TYSABRI. Both MS patients were receiving concomitant immunomodulatory therapy, while the CD patient had also received immunosuppressive therapy in the past. Recently, however, two additional cases of PML were identified in Europe in the post-marketing setting, occurring in MS patients who were being treated with TYSABRI monotherapy. Both patients had received TYSABRI for more than one year. In December 2008, Biogen Idec and Elan Pharmaceuticals announced that a multiple sclerosis patient treated with TYSABRI monotherapy, who contracted PML months earlier, passed away due to complications from the infection. The patient, who had been diagnosed in October 2008, was in the United States. Also in December 2008, PML was detected in a European patient who had been taking Tysabri monotherapy for 26 months. According to Biogen, the patient is currently under a physician’s care. According to the FDA, the incidence of PML appears to be lower with monotherapy, however, there are too few cases to reliably conclude that the true risk of PML is lower in this population versus the population receiving concomitant immunomodulatory medications. In September 2009, reports of progressive multifocal leukoencephalopathy(PML) were being received by the FDA. Thirteen reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for multiple sclerosis with Tysabri monotherapy
Clinically significant liver injury has been known to occur in the post-marketing setting. Signs of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as 6 days after the first dose. It is recommended to discontinue TYSABRI in patients with jaundice or other evidence of significant liver injury.
The label for TYSABRI was changed in July 2010 to indicate that patients treated with immunosuppressant therapy (defined as mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, or cladribine) prior to receiving TYSABRI have an increased risk of PML. This increased risk appears to be independent of TYSABRI treatment duration. Note: corticosteroids were not included in the definition of prior immunosuppressant therapy.
The label for TYSABRI was changed again on March 2011 to give new information about the size of the risk of PML. The update includes new safety information about patients who have taken other drugs that suppress the immune system, who may be at a higher risk for PML.
The label for Tysabri was changed again on January 2012 to include in the warnings/precautions section that the risk of PML was seen with Tysabri use with the presence of anti-JC virus antibodies (anti-JCV antibody assay).
The label for Tysabri® was changed again on December 2013 to include in the Boxed Warnings section: “Risk factors for the development of PML include duration of therapy, prior use of immunosuppressants, and presence of anti-JCV antibodies. These factors should be considered in the context of expected benefit when initiating and continuing treatment with Tysabri®.” This was previously included in the warnings/precautions section. The indications and usage section was updated to include: “Tysabri increases the risk of PML. When initiating and continuing treatment with Tysabri®, physicians should consider whether the expected benefit of Tysabri® is sufficient to offset this risk.” The warnings and precautions section includes new information on herpes encephalitis and meningitis. Life-threatening and fatal cases have occurred. Blindness has occurred in patients developing acute retinal necrosis. Tysabri should be discontinued if these herpes infections occur and treated appropriately
[INFORMATIONAL NOTE: Tysabri packaging includes the following BLACK BOX WARNINGS:
- TYSABRI increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability
- Risk factors for the development of PML include duration of therapy, prior use of immunosuppressants, and presence of anti-JCV antibodies. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYSABRI
- Monitor patients, and withhold TYSABRI immediately at the first sign or symptom suggestive of PML
- Because of the risk of PML, TYSABRI is available only through a special restricted distribution program called the TOUCH Prescribing Program. Under the TOUCH Prescribing Program, only prescribers, infusion centers, and pharmacies associated with infusion centers registered with the program are able to prescribe, distribute, or infuse the product. For prescribers and patients, the TOUCH Prescribing Program has two components: MS TOUCH and CD TOUCH. In addition, TYSABRI must be administered only to patients who are enrolled in and meet all of the conditions of the TOUCH Prescribing Program.
- Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML. TYSABRI dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation that includes a gadolinium-enhanced magnetic resonance imaging (MRI) scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.]
[INFORMATIONAL NOTE: Progressive Multifocal Leukoencephalopathy (PML) has occurred in patients who received Tysabri. Patients who have significantly compromised immune system function should not ordinarily be treated with Tysabri. Obtain an MRI scan in MS patients prior to initiating Tysabri. Monitor MS and CD patients and withhold Tysabri at the first sign or symptom suggestive of PML. Treatment duration, prior immunosuppressant use, and presence of anti-JC virus antibodies are associated with increased risk of PML in Tysabri-treated patients.]
Policy:
(Note: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
The requirements of the Horizon BCBSNJ Natalizumab (Tysabri) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).
1. Natalizumab (Tysabri) is medically necessary in adults for the following FDA-approved indications that correspond to the specific type of indication:
- As monotherapy for members who meet all of the following criteria:
- Confirmed diagnosis (i.e. MRI report) of relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive (to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations); AND
- Had inadequate response (defined as documented failure by one or more relapses, two or more unequivocally new MRI-detected lesions, or increased disability on examination) to a minimum 3-month trial on previous therapy with OR are unable to tolerate at least TWO alternative MS therapies (examples include but are not limited to: an interferon beta product (Avonex, Rebif, Betaseron, Extavia), glatiramer acetate (Copaxone), dimethyl fumarate (Tecfidera), fingolimod (Gilenya), etc.) OR
- Member is treatment-naïve but presents with aggressive disease defined as one of the following:
- two or more relapses in the preceding year and 2 or more gadolinium enhancing lesions on brain MRI scan or a significant T 2 lesion burden (T2 lesion burden being determined by factoring the number of lesions, the size of the lesions and lesion location) or
- one relapse if it results in sustained EDSS of 3.0 along with 2 or more gadolinium enhancing lesions or significant T2 lesion burden ( T2 lesion burden being determined by factoring the number of lesions, the size of the lesions and lesion location) AND
- Enrolled in MS TOUCH Prescribing Program; AND
- Documented negative JCV-antibody ELISA test within the past 6 months
- Baseline measurement of any objective measurement tools (e.g. expanded disability status scale (EDSS score), timed 25-foot walk (T25-FW), 9-hole peg test (9-HPT), annualized relapse rate, etc.)
- For induction therapy and maintaining clinical response and remission in members who meet all of the following criteria:
- Diagnosis of moderate to severe active Crohn’s disease (CD) in adults with evidence of inflammation;
- Had an inadequate response to OR are unable to tolerate conventional CD therapies (e.g immunosuppressants (e.g. 5-ASA, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate):
- Member had inadequate response to self injectable TNF antagonist due to efficacy or tolerability;
- NOT in combination therapy with immunosuppressants or inhibitors of TNF-α;
- Enrolled in CD TOUCH Prescribing Program; AND
- Documented negative JCV-antibody ELISA test within the past 6 months
[INFORMATIONAL NOTE: In the postmarketing setting, additional cases of PML have been reported in multiple sclerosis and Crohn’s disease patients who were receiving no concomitant immunomodulatory therapy. Three factors known to increase the risk of PML in Tysabri-treated patients include: treatment duration that exceeds beyond 2 years, prior treatment with an immunosuppressant (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate mofetil) and in patients who are anti-JCV antibody positive. In addition, the gastroenterology guidelines and neurology guidelines recommend the following: the use of natalizumab for 25–36 months with no prior use of immunosuppressants, the PML risk is 0.2 per 1,000 in those with an index of 0.9 or less, 0.3 per 1,000 in those with an index of 0.9–1.5, and 3 per 1,000 in those with an index greater than 1.5.
The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more additional risk factors. Patients with all three known risk factors have an estimated risk of PML of 11/1,000. Post marketing data show that the risk of developing PML may be associated with relative levels of serum anti-JCV antibody
Consideration should be given to testing patients for anti-JCV antibody status prior to treatment or during treatment if antibody status is unknown. Infection by the JC virus is required for the development of PML. Anti-JCV antibody negative status indicates that exposure to the JC virus has not been detected. Patients who are anti-JCV antibody negative are still at risk for the development of PML due to the potential for a new JCV infection or a false negative test result. Therefore, patients with a negative anti-JCV antibody test result should be retested periodically. For purposes of risk assessment, a patient with a positive anti-JCV antibody test at any time is considered anti-JCV antibody positive regardless of the results of any prior or subsequent anti-JCV antibody testing. When assessed, anti-JCV antibody status should be determined using an analytically and clinically validated immunoassay.
As per Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis - Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Acadeomy of Neurology:
PML is a serious safety concern that may affect compliance and necessitate consideration of a treatment switch. The PML risk is estimated at 4 per 1,000 overall with natalizumab; however, the presence and index level of JCV antibodies, longer duration use, and prior immunosuppression increase PML risk with natalizumab even further. Recent updated risk estimates show that the risk of developing PML is small at antibody index values of 0.9 or less, and increases with index values greater than 1.5 in people with MS who have been treated with natalizumab for more than 2 years. There are rare reports of PML with the use of both fingolimod and dimethyl fumarate. There are reports of PML in people with MS who are HIV-negative and using rituximab for conditions other than MS. There is a potential risk of PML with ocrelizumab use, particularly with prior immunosuppressive therapies based on its similarity to other anti-CD20 antibodies.
Clinicians should counsel people with MS considering natalizumab, fingolimod, rituximab, ocrelizumab, and dimethyl fumarate about the PML risk associated with these agents (Level B). Clinicians should discuss switching to a DMT with a lower PML risk with people with MS taking natalizumab who are or become JCV antibody–positive, especially with an index of above 0.9 while on therapy (Level B).
People with MS with a positive John Cunningham virus (JCV) antibody test have a higher risk of developing progressive multifocal leukoencephalopathy (PML) while using natalizumab, particularly people with MS who have been treated for more than 2 years or have had prior immunosuppressive treatment. There are now other highly effective treatments that may be used that have not been shown to have a similar PML risk. The PML risk increases with the level of anti-JCV antibody response (index). For example, in those using natalizumab for 25–36 months with no prior use of immunosuppressants, the PML risk is 0.2 per 1,000 in those with an index of 0.9 or less, 0.3 per 1,000 in those with an index of 0.9–1.5, and 3 per 1,000 in those with an index greater than 1.5. Further data on risk assessment is likely to become available over time to help inform treatment decisions in this area.
Clinicians may initiate natalizumab treatment in people with MS with positive anti-JCV antibody indexes above 0.9 only when there is a reasonable chance of benefit compared with the low but serious risk of PML (Level C)
As per 2018 ACG Clinical Guideline: Management of Crohn's Disease in Adults: Natalizumab should be used for maintenance of natalizumab-induced remission of Crohn’s disease only if serum antibody to John Cunningham (JC) virus is negative. Testing for anti-JC virus antibody should be repeated every 6 months and treatment stopped if the result is positive (strong recommendation, moderate level of evidence.]
2. When natalizumab (Tysabri) is medically necessary, initial therapy will be approved for a period of 12 weeks for Crohn’s disease, and 6 months for multiple sclerosis, at the following FDA recommended dose:
Tysabri (natalizumab): 300 mg IV infusion over 1 hour, given every 4 weeks.
3. At the end of the initial approval period, the need for continued therapy will be evaluated based on improvement of symptoms and/or stabilization of disease. If the therapy is continued, it will be approved for a year and evaluated annually for continued use based on following indications and criteria:
- Multiple Sclerosis
- Adequate documentation of disease stability and/or improvement (i.e., EDSS scores, no relapse, and/or chart notes); AND
- Patient continues to meet initial review criteria; AND
- Absence of unacceptable toxicity from the drug. (e.g.: hypersensitivity reactions; hepatoxicity; acute retinal necrosis; signs or symptoms of progressive multifocal leukoencephalopathy (PML ); development of severe infections (including pneumonias, pneumocystis carinii pneumonia, pulmonary mycobacterium avium intracellular, bronchopulmonary aspergillosis, herpes, urinary tract, gastroenteritis, vaginal, tonsillitis cryptococcal fungemia, meningitis, and candida pneumonia); AND
- Documented negative JCV-antibody ELISA test within the past 6 months.
- Crohn’s Disease
- Clinical response and remission of disease is seen by 12 weeks; AND
- Patient has been tapered off of oral corticosteroids within six months of starting Tysabri except for first renewal of therapy (this applies to all subsequent renewals after the first renewal); AND
- Patient does not require additional steroid use that exceeds three months in a calendar year to control their Crohn’s disease
- Patient continues to meet initial review criteria; AND
- Absence of unacceptable toxicity from the drug. (e.g.: hypersensitivity reactions; hepatoxicity; acute retinal necrosis; signs or symptoms of progressive multifocal leukoencephalopathy (PML ); development of severe infections (including pneumonias, pneumocystis carinii pneumonia, pulmonary mycobacterium avium intracellular, bronchopulmonary aspergillosis, herpes, urinary tract, gastroenteritis, vaginal, tonsillitis cryptococcal fungemia, meningitis, and candida pneumonia); AND
- Documented negative JCV-antibody ELISA test within the past 6 months
[INFORMATIONAL NOTE: Based on the FDA package labeling, there is limited clinical experience of Tysabri treatment beyond 4 years as this puts the patient at a greater risk for PML.]
[INFORMATIONAL NOTE: Disease stability and/or improvement may include the following: continuous monitoring of response to therapy [manifestations of MS disease activity include, but are not limited to, an increase in annualized relapse rate (ARR), development of new/worsening T2 hyperintensities or enhancing lesions on brain/spinal MRI, and progression of sustained impairment as evidenced by expanded disability status scale (EDSS), timed 25-foot walk (T25-FW), 9-hole peg test (9-HPT)]
[INFORMATIONAL NOTE: The FDA approved package insert recommends, in Crohn’s disease, to discontinue the drug in patients that have not experienced therapeutic benefit by 12 weeks of induction therapy, and in patients that cannot discontinue chronic concomitant steroids within six months of starting TYSABRI therapy. Other than the initial 6-month taper, prescribers should also consider discontinuing TYSABRI for patients who require additional steroid use that exceeds 3 months to control their Crohn’s disease.]
4. Other uses of natalizumab (Tysabri) are considered investigational.
Medicare Coverage
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ medical policy.
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:
Natalizumab (Tysabri)
Crohn’s Disease; Natalizumab (Tysabri)
Multiple Sclerosis; Natalizumab (Tysabri)
Tysabri (Natalizumab)
References:
1. Tysabri® (natalizumab) [Prescribing Information]. Biogen Idec Inc. Cambridge, MA. June 2020.
2. Sandborn WJ, Colombel JF, Enns R et al. Natalizumab induction and maintenance therapy for Crohn’s disease. NEJM Nov 2005; 353(18): 1912-1925.
3. Targan SR, Feagan BG, Fedorak RN et al. Natalizumab for the treatment of active Crohn’s disease: results of the ENCORE trial. Gastroenterology
May 2007; 132(5): 1672-1683.
4. Biogen Idec Inc [homepage on the Internet]. c2005. [updated 2005 Sept 26; cited 2005 Oct 17]. Press Release: Biogen Idec and Elan Submit Supplemental Biologics License Application to the FDA for TYSABRI® in Multiple Sclerosis (9/26/05); [about 2 screens]. [Available from:http://www.biogenidec.com/site/019_0.html?pr_id=../news/BiogenIDECPR_093.htm]
5. Goodman A, Bar-Or A, Miller A, et al. GLANCE: a double-blind, randomized, placebo-controlled, parallel-group safety study of natalizumab in
combination with glatiramer acetate (Copaxone) in subjects with RRMS. [Abstract] 14th Meeting of European Neurological Society June 26-30, 2004;
Barcelona, Spain; P689.
6. Polman CH, O’Connor PW, Havrdova E, et al. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med
2006; 354: 899-910.
7. Rudick RA, Stuart WH, Calabresi PA, et al. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med 2006;354:911-923.
8. Yousry TA, Habil M, Major EO, et al. Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy. N Engl J Med
2006;354:924-933.
9. Micromedex Health Series. Thomson Gateway. [Available at: http://www.thomsonhc.com/hcs/librarian/PFPUI/AH1fgpoxqU9YR]
10. McEvoy GK, ed in chief, Miller J, ed. AHFS: Drug Information. Bethesda, MD: American Society of Health-System Pharmacists;2013:3643-3648.
11. U.S. Food and Drug Administration: FDA News. Natalizumab Injection for Intravenous Use. August 2008. [Available at: http://www.fda.gov/cder/drug/InfoSheets/HCP/natalizumab2008HCP.htm]
12. Jeffrey, S. Tysabri PML patient dies, companies report. Medscape Medical News. December 22, 2008. [Available at: http://www.medscape.com/viewarticle/585770]
13. U.S. Food and Drug Administration. Information on Natalizumab (marketed as Tysabri). September 2009. [Available at:http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107198.htm]
14. Iaffaldano P, D’Onghia M, Trojano M, et al. Safety profile of Tysabri: international risk management plan. Neurol Sci (2009) 30 (Suppl 3): S159-S162.
15. Lichtenstein G, Hanauer S, Sandborn W, et al. Management of Crohn ’ s Disease in Adults. Am J Gastroenterol advance online publication, 6 January 2009.
16. Nicholas JA, Racke MK, Imitola J, et al. First-line natalizumab in multiple sclerosis: rationale, patient selection, benefits and risks. Ther Adv Chronic Dis (2014) 5 (2) 62-68.
17. Goodin DS, Frohman EM, Garmany GP Jr, et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology. 2002 Jan 22;58(2):169-78.
18. Mellen Center Approaches: Natalizumab. Cleveland Clinic. Available at: https://my.clevelandclinic.org/ccf/media/Files/Neurological-Institute/mellen-center/13-neu-533-natalizumab-fact-sheet.pdf?la=en
19. Lichtenstein GR, Loftus EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol 2018; 113:481–517; doi: 10.1038/ajg.2018.27. Accessed on June 6, 2019.
20. Rae-Grant, A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis. Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology® 2018;90:777-788. Accessed on June 5, 2019 at https://www.who.int/selection_medicines/committees/expert/22/applications/s8.1_multiplesclerosisDMT_Appendix1B.pdf
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*
HCPCS
* 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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