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Nab-Paclitaxel (e.g., Abraxane) | |
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Description: |
Paclitaxel protein-bound particles, also known as “nanoparticle albumin-bound” (nab)-paclitaxel, are microtubule inhibitors that result in the assembly and stabilization of microtubules by preventing depolymerization. This stability results in the inhibition of interphase and mitotic cellular functions, preventing cell division. (Clinical Pharmacology, 2017).
Regulatory Status
In January 2005, Nab-Paclitaxel (e.g., Abraxane) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) was approved for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
In October 2012, the FDA approved Nab-Paclitaxel (e.g., Abraxane) for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), as first-line treatment in combination with carboplatin, in individuals who are not candidates for curative surgery or radiation therapy.
In September 2013, the FDA approved Nab-Paclitaxel (e.g., Abraxane) for a new indication for the first-line treatment of individuals with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine (U.S. Food and Drug Administration 2005, 2012, 2013).
In March 2019, the FDA approved Nab-Paclitaxel (e.g., Abraxane) for treatment of individuals with unresectable locally advanced or metastatic triple-negative breast cancer that is PD-L1 positive, in combination with atezolizumab. This indication has been approved under accelerated approval designation based on progression-free-survival data. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Coding
See CPT/HCPCS Code section below.
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Policy/ Coverage: |
Effective August 1, 2021, for members of plans that utilize an oncology benefits management program, Prior Approval is required for this service and is managed through the oncology benefits management program.
The Step Therapy Medication Act is applicable to fully insured (Arkansas Blue Cross, Health Advantage, and Exchange) and specified governmental (ASE/PSE and ASP) health plans. The law is not applicable to FEP or self-insured ERISA groups (including but not limited to Walmar or other Blue Advantage groups). Initial approval for exigent request is 28 days. Otherwise, initial approval for standard review is up to 1 year.
Effective April 9, 2025
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Nab-paclitaxel (e.g., Abraxane) meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:
For FDA labeled indications, Nab-paclitaxel (e.g., Abraxane) must be dosed in accordance with the indication specific recommended dose per FDA label unless otherwise specified in the dosage and administration section.
For off-label indications, authorizations will not exceed the maximum FDA labeled dose and frequency across all the FDA labeled indications unless higher dose is allowed for the specific indication in the dosage and administration section.
FDA Labeled Indications
The use of this drug is covered if an FDA-approved oncologic indication exists [not listed as an indication below with the member meeting all of the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”)].
BREAST CANCER
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
NON-SMAL LUNG CANCER (NSCLC)
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
PANCREATIC CANCER
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 12 months:
Off-Label Indications
The use of this drug for off-label indications not listed below is subject to policy 2000030.
The following indications are covered when the individual meets the related NCCN category 1 or 2A recommendations specific to the indications below (e.g., histology, cancer staging, surgical status, mono- or combination therapy, and previous lines of therapy):
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 12 months:
Please see the NCCN Drugs and Biologics Compendium for a complete list of NCCN 1 & 2A indications. To view the most recent and complete version of the guideline or Compendium, go online to NCCN.org. Please note, NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Policy Guidelines
Eastern Cooperative Oncology Group Performance Status (ECOG) (ECOG-ACRIN Cancer Research Group, 2022)
Dosage and administration
Dosing per FDA Guidelines unless otherwise specified below.
Metastatic Breast Cancer (MBC): Recommended dosage is 260 mg/square meters intravenously over 30 minutes every 3 weeks.
Non-Small Cell Lung Cancer (NSCLC): Recommended dosage is 100 mg/square meters intravenously over 30 minutes on Days 1, 8, and 15 of each 21-day cycle; administer carboplatin on Day 1 of each 21-day cycle immediately after nab-paclitaxel.
Adenocarcinoma of the Pancreas: Recommended dosage is 125 mg/square meters intravenously over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle; administer gemcitabine on Day 1 of each 21-day cycle immediately after nab-paclitaxel.
Nab-paclitaxel is available as 100 mg lyophilized powder in a single-dose vial for reconstitution.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Nab-paclitaxel (e.g., Abraxane) for any indication or circumstance not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving outcomes.
For members with contracts without primary coverage criteria, Nab-paclitaxel (e.g., Abraxane) for any indication or circumstance not described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective April 17, 2024 to April 8, 2025
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Nab-paclitaxel meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:
FDA Approved Indications
For FDA labeled indications, all products must be dosed in accordance with the FDA label unless otherwise specified.
STANDARD REVIEW for up to 12 months:
Off-Label Indications
For off-label indications, authorizations will not exceed 260 mg per square meter of body surface area unless medical literature supports a higher dose.
STANDARD REVIEW for up to 12 months:
Eastern Cooperative Oncology Group Performance Status (ECOG)
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
Dosage and administration
Dosing per FDA Guidelines
Metastatic Breast Cancer (MBC): Recommended dosage is 260 mg/square meters intravenously over 30 minutes every 3 weeks.
Non-Small Cell Lung Cancer (NSCLC): Recommended dosage is 100 mg/square meters intravenously over 30 minutes on Days 1, 8, and 15 of each 21-day cycle; administer carboplatin on Day 1 of each 21-day cycle immediately after nab-paclitaxel.
Adenocarcinoma of the Pancreas: Recommended dosage is 125 mg/square meters intravenously over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle; administer gemcitabine on Day 1 of each 21-day cycle immediately after nab-paclitaxel.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Nab-paclitaxel (e.g., Abraxane) for any indication or circumstance not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving outcomes.
For members with contracts without primary coverage criteria, Nab-paclitaxel (e.g., Abraxane) for any indication or circumstance not described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective June 1, 2022 to April 16, 2024
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Nab-paclitaxel meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the treatment of the following listed indications:
Breast Cancer
Hepatobiliary Cancers-Biliary Tract Cancers: Gallbladder Cancer
Hepatobiliary Cancers-Biliary Tract Cancers: Intrahepatic Cholangiocarcinoma
Hepatobiliary Cancers-Biliary Tract Cancers: Extrahepatic Cholangiocarcinoma
Kaposi Sarcoma
Cutaneous Melanoma
Uveal Melanoma
Non-Small Cell Lung Cancer
Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer-Includes Epithelial, Malignant Mixed Mullerian Tumors, Clear Cell Carcinoma, Mucinous Carcinoma, Grade 1 Endometrioid Carcinoma, Low-Grade Serous Carcinoma/Ovarian Borderline Epithelial Tumors
Pancreatic Adenocarcinoma
Small Bowel Adenocarcinoma-Small Bowel Adenocarcinoma
Small Bowel Adenocarcinoma- Advanced Ampullary Cancer
Uterine Neoplasms-Endometrial Carcinoma
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
Dosage and administration
Dosing per FDA Guidelines
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of Nab-paclitaxel for any indication or circumstance other than those outlined above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of efftectiveness in improving outcomes.
For members with contracts without primary coverage criteria, the use of Nab-paclitaxel for any other indication or circumstance other tha circumstances than those outlined above is considered investigational.
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Due to the detail of the policy statement, the document containing the coverage statements for dates prior to June 1, 2022 are not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com
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Rationale: |
The safety and efficacy of nab-paclitaxel (ABI-007) was evaluated in a multicenter phase II clinical trial in which 63 women with histologically confirmed and measurable metastatic breast cancer (MBC) were treated with nab-paclitaxel by IV infusion. 48 patients had received prior chemotherapy, and 39 patients had not received prior treatment. Overall response rates (complete or partial responses) were 48% for all patients. For patients who received nab-paclitaxel as first-line and greater than first-line therapy for their metastatic disease, the respective response rates were 64% and 21%. Median time to disease progression was 26.6 weeks, and median survival was 63.6 weeks. No severe hypersensitivity reactions were reported. Toxicities observed were typical of paclitaxel and included neutropenia (24%), sensory neuropathy (11%), and febrile neutropenia (5%). Patients received a median of six treatment cycles. The authors concluded that treatment with nab-paclitaxel resulted in significant antitumor activity in patients with MBC, including those receiving the drug as first-line therapy (Ibrahim et al, 2005).
The safety and efficacy of nab-paclitaxel (ABI-007) was evaluated also evaluated in a comparative phase III trial in which 454 patients with metastatic breast cancer (MBC) were treated with either nab-paclitaxel or standard paclitaxel. ABI-007 demonstrated significantly higher response rates compared with standard paclitaxel (33% v 19%, respectively) and significantly longer time to tumor progression (23.0 v 16.9 weeks, respectively). The incidence of grade 4 neutropenia was significantly lower for nab-paclitaxel compared with standard paclitaxel (9% v 22%, respectively) despite a 49% higher paclitaxel dose. Grade 3 sensory neuropathy was more common in the nab-paclitaxel arm than in the standard paclitaxel arm (10% v 2%, respectively). No hypersensitivity reactions occurred with ABI-007 despite the absence of premedication and shorter administration time. The authors concluded that nab-paclitaxel demonstrated greater efficacy and a favorable safety profile compared with standard paclitaxel in patients with MBC (Gradishar et al, 2005).
The safety and efficacy of nab-paclitaxel plus carboplatin in advanced NSCLC was evaluated in a phase III clinical trial in which 1052 untreated patients with phase III to IV NSCLC were randomly assigned to received either nab-paclitaxel plus carboplatin or solvent-based paclitaxel plus carboplatin. Nab-paclitaxel was as effective as sb-paclitaxel. PFS was 6.3 months for the nab-paclitaxel group, as compared to the sb-paclitaxel group at 5.8 months. Overall survival was 12.1 in the nab-paclitaxel group versus 11.2 months in the sb-paclitaxel group. Safety was demonstrated in that significantly less neuropathy, neutropenia , arthralgia and myalgia occurred in the nab-paclitaxel groups. However, less thrombocytopenia and anemia occurred in the sb-paclitaxel groups. (Socinski, 2012)
The efficacy of nab-paclitaxel in recurrent ovarian, peritoneal and Fallopian tube was evaluated by two studies. The first was a phase II clinical trial in which 47 patients with histologically or cytologically confirmed epithelial cancer of the ovary, Fallopian tube, or peritoneum received nab-paclitaxel 260mg/m2 every 21 days for 6 cycles or until disease progression. The ORR was 64% (15 complete responses and 13 partial responses). Estimated median progression-free survival (PFS) was 8.5 months. (Teneriello, 2009). The second study evaluating nab-paclitaxel included 47 patients with platinum- and -taxane resistant cancer defined by persistence or progression after primary chemotherapy or recurrence within 6 months of completing treatment. The median progression-free survival (PFS) was 4.5 months. Overall survival was 17.4 months. (Coleman, 2011)
Nab-paclitaxel was evaluated for the treatment of recurrent or persistent advanced cervical cancer in a Phase II trial in which 37 patients were enrolled, and 35 were eligible. Of the 35 patients, 10 had a partial response and 25 had stable disease. Median PFS was 5 months and median overall survival was 9.4 months. Adverse events included neutropenia in 2 patients, which resolved with dose reduction and grade III neurotoxicity in 1 patient which resolved upon discontinuation. (Alberts, 2012)
Treatment options for urothelial cancer are limited, with typical responses less than 20% and without survival benefit. Nab-paclitaxel was studied for metastatic urothelial carcinoma in an open-label single group multicenter study. Patients were at least 18 years old with histologically-confirmed locally advanced or metastatic urothelial cancer. Treatment continued until disease progression or occurrence of unacceptable toxic effects. The primary end-point was objective tumor response, defined by a CR or PR according to Response Evaluation Criteria in Solid Tumors criteria. The study enrolled 48 patients; 1 had a complete response and 12 had a partial response for an ORR of 27.7%. (Ko, 2013)
Nab-paclitaxel was evaluated in histologically or cytologically confirmed metastatic melanoma in a cohort study that included 37 chemotherapy-naïve patients and 37 previously treated patients. The median progression-free survival (PFS) was 3.5 months for previously treated and 4.5 months for chemotherapy-naïve patients, and the median survival was 12.1 months and 9.6 months, respectively. The probability of being alive and free of disease progression at 6 months was 27% for the previously treated cohort and 34% for the chemotherapy-naive cohort; the probability of surviving 1 year was 49% and 41%, respectively, for the previously treated and chemotherapy-naive cohorts. Authors noted that this response rate, PFS, and survival compare favorably to current standard therapy. (Hersh, 2010) Another study of nab-paclitaxel in metastatic melanoma enrolled 76 patients in a phase II trial in which patients with unresectable stage IV melanoma received nab-paclitaxel and carboplatin. Of the patients enrolled, 41 where chemotherapy-naïve and 35 had received prior treatment. There were 10 responses in the chemotherapy naïve cohort (25.6%) and 3 responses in the prior treatment cohort (8.8%). Median progression-free survival was 4.5 months in the CN cohort and 4.1 months in the PT cohort. Median overall survival (OS) was 11.1 months in the CN group and 10.9 months in the PT group. (Kottschade, 2011)
Nab-paclitaxel was evaluated for use in the treatment of invasive bladder cancer in a phase-1 study which enrolled 18 patients with recurrent, high grade (Ta, T1 and Tis) transitional cell carcinoma of the bladder for which at least 1 prior standard intravesical regimen failed. Of the 18 patients 5 (28%) had no evidence of disease at posttreatment evaluation (McKiernan et al, 2011).
2019 Update
A literature search conducted through March 2019 did not reveal any new information that would prompt a change in the coverage statement.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using MEDLINE database through April 2023. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2024.
2025 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2025.
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CPT/HCPCS: | |
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References: |
Alberts DS, Blessing JA, Landrum LM, et al.(2012) Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer: A gynecologic oncology group study. Gynecologic oncology. 2012;127(3):451-455. doi:10.1016/j.ygyno.2012.09.008. Celgene Corporation.(2015) Abraxane® [package insert]. Summit, NJ: Celgene Corporation.; 2015 Clinical Pharmacology [Internet].(2017) Nanoparticle Albumin-Bound Paclitaxel. Tampa (FL): Elsevier. c2017- [cited 2017 March 14]. Available from: http://www.clinicalpharmacology.com Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, Hawkins M, and O'Shaughnessy J.(2005) Phase III Trial of Nanoparticle Albumin-Bound Paclitaxel Compared With Polyethylated Castor Oil–Based Paclitaxel in Women With Breast Cancer. Journal of Clinical Oncology 2005 23:31, 7794-7803 Hersh, E. M., O'Day, S. J., Ribas, A., Samlowski, W. E., Gordon, M. S., Shechter, D. E., Clawson, A. A. and Gonzalez, R.(2010) A phase 2 clinical trial of nab-paclitaxel in previously treated and chemotherapy-naive patients with metastatic melanoma. Cancer, 2010.116: 155–163. doi:10.1002/cncr.24720 Ibrahim NK, Samuels B, Page R, Doval D, Patel KM, Rao SC, Nair MK, Bhar P, Desai N, and Hortobagyi GN.(2005) Multicenter Phase II Trial of ABI-007, an Albumin-Bound Paclitaxel, in Women With Metastatic Breast Cancer. Journal of Clinical Oncology 2005 23:25, 6019-6026 Ko YJ, Canil CM, Mukherjee SD, et al.(2013) Nanoparticle albumin-bound paclitaxel for second-line treatment of metastatic urothelial carcinoma: A single group, multicentre, phase 2 study. Lancet Oncol. 2013;14(8):769-776. Kottschade LA, Suman VJ, Amatruda T 3rd, et al.(2011) A phase II trial of nab-paclitaxel (ABI-007) and carboplatin in patients with unresectable stage IV melanoma : A North Central Cancer Treatment Group Study, N057E(1). Cancer. 2011;117(8):1704-1710. McKiernan JM, Barlow LJ, Laudano MA, et al.(2011) A phase I trial of intravesical nanoparticle albumin-bound paclitaxel in the treatment of bacillus Calmette-Guérin refractory nonmuscle invasive bladder cancer. J Urol. 2011;186(2):448-451. National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed on September 01, 2021. Breast Cancer. V8.2021. Revised September 13, 2021. National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™ NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Accessed on September 01, 2021. Hepatobiliary Cancers. V5.2021. Revised September 21, 2021. National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. . NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/cervical.pdf. Accessed on September 01, 2021. Cervical Cancer. V1.2021. Revised October 2, 2020. National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/uveal.pdf. Accessed on September 20, 2021. Melanoma: Uveal. V2.2021. Revised June 25, 2021. National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/kaposi.pdf. Accessed on September 01, 2021. Karposi Sarcoma. V2.2021. Revised June 7, 2021. National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed on September 20, 2021. Non-Small Cell Lung Cancer. V6.2021. Revised September 30, 2021. National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. Accessed on September 20, 2021. Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer v.3.2021. Revised September 9, 2021. National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Accessed on September 20, 2021. Pancreatic Adenocarcinoma. V2.2021. Revised February 25, 2021. National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/small_bowel.pdf. Accessed on September 20, 2021. Small Bowel Adenocarcinoma v.2.2021. Revised September 10, 2021. National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf. Accessed on September 20, 2021. Uterine Neoplasms. V4.2021. Revised September 3, 2021. National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™.NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/cutaneous_melanoma.pdf . Accessed on September 20, 2021. Melanoma: Cutaneous. V2.2021. Revised February 19, 2021. NCCN(2017) NCCN Compendia. https://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=5. Accessed March 14, 2017. Socinski MA, Bondarenko I, Karaseva NA, et al.(2012) Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: Final results of a phase III trial. J Clin Oncol. 2012;30(17):2055-2062. |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2025 American Medical Association. |