Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Added “Aria” to Simponi to designate IV formulation. Background U.S. Food and Drug Administration (FDA)-Approved Indications. %%EOF
RECENT MAJOR CHANGES . Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com. SOLIRIS can lower the ability of your immune system to fight infections. h�b```��,�� ��ea���"��F������P�J��:������6��ڸZ�6p4p4t r4�+QF�H �6���$�?DX�h�T�"���sG�����Q`}b�&�@ʁ�-�30��@�e 9��#��e`�v�(cL0 4�'�
Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). %%EOF
Description. 0
Billing Code/Availability Information HCPCS Code: J1303 − Injection, ravulizumab-cwvz, 10 mg; 1 billable unit = 10 mg NDC: Ultomiris 300 mg/3 mL single-use vials for injection: 25682-0025-xx Code Maximum Allowed Brand Generic Soliris eculizumab aHUS 300 mg vials 25682-0001-01 4 vials/120 ml MG/NMOSD 300 mg vials 25682-0001-01 4 vials/120ml PNH 300 mg vials 25682-0001-01 3 vials/90ml Ultomiris ravulizumab-cwvz - 300 mg/30 mL solution in vials 25682-0022-01 360 mL endstream
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VI. GR-68742 (11-20) Page 1 of 2 Soliris® (eculizumab) Injectable Medication Precertification Request Aetna Precertification Notification Phone: 1-866-752-7021 . endstream
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1 INDICATIONS AND USAGE 1.1 Paroxysmal Nocturnal Hemoglobinuria (PNH) Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. See Important Safety Information, including Boxed Warning, and full Prescribing Information. Generic Name Trade Name … There are 0 new musculoskeletal CPT codes added with 0 deletions and 2 major revisions along with an extensive update to arthroscopic loose body removal requirements. a The mean (SD) terminal elimination half-life and clearance of ravulizumab-cwvz in patients with PNH are 49.7 (8.9) days and 0.08 (0.022) L/day, respectively. FAX: 1-888-267-3277 h�bbd```b``�"W�H�o ��X|*X�,�D���H�zV+��&X� �d�V�e��&4�Eb��ȁH�z�?D���`���)�I0 Instead, the administration of the following drugs in their subcutaneous or intramuscular forms should be billed using CPT code 96372. Listing of a code in this policy does not imply that the service is covered and is not a guarantee of payment. CPT Code 90620 (2-dose schedule) and meningococcal recombinant lipoprotein vaccine, Trumenba®, CPT Code 90621 (3-dose schedule). Policy section and coding updated with Soliris. Under the Soliris REMS , prescribers must enroll in the program (5.2). Source: Alexion Pharmaceuticals, 2019a. per Administration HCPCS Code Maximum Allowed Brand Generic Soliris eculizumab aHUS 1200 mg J1300 120 HCPCS units (10 mg per unit) MG/NMOSD 1200 mg J1300 120 HCPCS units (10 mg per unit) PNH 900 mg J1300 90 HCPCS units (10 mg per unit) HCPCS Code Based Maximum Dosage Information Medi-Cal Code Medi-Cal Description Age Group CHDP Code CHDP Description Reimbursement 90620 Bexsero® 10 years through 18 years 11 months* M1 VFC $9 For the drugs that are administered IV the CPT codes for IV injection/infusion should be used codes 96365-96368 and 96374-96375. Code Description HCPCS . 3�Vb%�H(?��Z���#E'{槌+D7�f89�;�:��p�/�R��d�����)+����%J��gK�㏀�E��)CH320�� i1��" ���e&� -��4�Dc'@� a�K�
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Admixed solutions of Soliris are stable for 24 hours at 2-8° C (36-46° F) and at room temperature. h�b```b``Ve`e`�*`d@ A6 ���d�°>��_s�+ׇ��-n�{W�P*������a��r�E�Y���pe>�a�(pe�c���@�� /T�4�W���������D0��t� �8� endstream
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ULTOMIRIS Coding & Billing Guide in PNH DOWNLOAD. %PDF-1.5
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Soliris® (eculizumab) treats anti-AChR antibody-positive gMG. Eculizumab (Soliris®) On June 27, 2019, The U.S. Food and Drug Administration approved Eculizumab (Soliris®) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. – Patient has had fewer relapses while on Soliris therapy Reauthorization is for 12 months Age Must be 2 months or older for aHUS diagnosis Must be 18 years of age or older for PNH, gMG or NMOSD diagnosis Suggested Codes ICD-10-CM diagnosis codes D59.3, D59.5, G70.00, G36.0 Billing HCPCS code J1300 (injection, eculizumab, 10 mg) CODING The Current Procedural Terminology (CPT®), Healthcare Common Procedure Coding System (HCPCS), and ICD -10 codes that may be listed in this policy are for reference purposes only. J1300 has been in effect since 01/01/2008. "y��l-��G0[H2&�!� �H�_��`6�Pf�$����s C�0
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�a�����^�[z�nIG9�ٽ0x�����r$'{a��ꀡA�ǰ�#o���ӓl��!�jޢ�.۾Xϧ�}�X����Z>f���8���t�G~���w�q��tz��~�2o,��[�vZgu��27�zj�5;��5w���4{z���R�J�ϛ�#�dz��>��ҳ��ON��n�\�3Pp�Fϲ�b��7��"[|�z.�GX8>_ܸئ��=��`ׇ�0oz^g�bv\~^� �T�?�=1�Y�"�e�TW����+�u���C���嬚���CQ���}>+����! HCPCS Code. Under the Soliris REMS, prescribers must enroll in the program.
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Dosing information for Soliris® (eculizumab). Visit Anthem.com to learn more about how these policies are used to determine patient coverage and medical necessity. Coding. * *PLEASE NOTE NEW ALPHA NUMERIC CHDP PROGRAM SERVICE CODES. VI. endstream
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*Note: for Soliris switch therapy please refer to the package insert for appropriate switch dosing. ���Z��h�� ��,(��ahY�/x�S���tX���0b���q�}�/����
�(S�� .h�Y��Q&A� dВ0� �`Co�Hr�������mS��55�5�5����g�>��Y�����c��L�q 03/01/17 Annual Review, approved February 14, 2017. Paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis Billing Code/Availability Information HCPCS code: J1300 – Injection, eculizumab, 10 mg; 1 billable unit = 10 mg NDC: Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. Drugs administered other than oral method, chemotherapy drugs. Eculizumab (Soliris®) and ravulizumab-cwvz (Ultomiris TM) are recombinant humanized monoclonal antibodies that bind to complement protein C5 and inhibits its enzymatic cleavage, blocks formation of the terminal complement complex, and thus prevents red cell lysis. For questions concerning the technical ***Note: This Medical Policy is complex and technical. J1300 is a valid 2021 HCPCS code for Injection, eculizumab, 10 mg or just “ Eculizumab injection ” for short, used in Medical care . %PDF-1.5
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Please visit CMS.gov or other payers’ websites to obtain additional guidance on their processes related to billing and coding for single-use vials and wastage. Under the Soliris REMS, prescribers must enroll in the program. 666 0 obj
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c'�{B¥��D �n~�ӓj9ϗ釄�y�n�(�Kߥ��u>�oaO'6��M��P��J$����i�|��W�2/넦��kT�cQ��8.˪~��C0�A��� ����F1ؽ0k�*D=|#�a0� The Soliris admixture should be administered by intravenous infusion over 35 minutes via gravity feed, a syringe-type pump, or an infusion pump. h��[mo�F�+�r@���}9l�NԮa9��F�JtLT&
�n�3�]jIS�#]�8!��rwv�ٗy8�܈�$�ȄR�J�P�k�I$1P�D ��$њAMK`ܲ�.��A�H(�8*���@���:���l�P���� �R%�hh
6b�m1@�q�M����. SOLIRIS is a medicine that affects your immune system. Added Renflexis to coverage criteria and to the coding section. Article: Ravulizumab (ALXN1210) vs. eculizumab in adult patients with PNH naïve to complement inhibitors: the 301 study ... Infusion-Related Reactions Administration of ULTOMIRIS may result in infusion-related reactions. HCPCS CPT Jcode - J0850, J1459, J1561, J1568, J2788 - Intravenous Immune Globulin (IVIG) References 1. Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com. Soliris [package insert]. 718 0 obj
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Dosage and Administration Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines. Soliris Policy: Drug Policy (Effective 10/01/2014) 1 ... APPLICABLE CODES..... 6. J1300 Injection, eculizumab (Soliris®), 10 mg J1303 Injection, ravulizumab-cwvz, (Ultomiris®) 10 mg (new code effective 10/1/19) Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). 09/01/17 Interim Review, approved August 15, 2017. Instead, the administration of the following drugs in their subcutaneous forms should be billed using CPT code 96372, (therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular). J1300. �# Administer Soliris at the recommended dosage regimen time points, or within two days of these time points. SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. This coding information may assist you as you complete the payer forms for PERJETA. Half-life of eculizumab is 11.25-17.25 days. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early. Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com. Other policies and coverage guidelines may apply. 06/20/17 Minor edit. PROCEDURES AND BILLING CODES To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, SOLIRIS is only available through a program called the SOLIRIS REMS. Indications and Usage (1.3) 10/2017 Dosage and Administration (2.4, 2.5) 10/2017 Dosage and Administration (2.5, 2.6, 2.7) 07/2018 Boston, MA; Alexion … [���RU���1�_�'y[쐴p@��~X�j A��0�GX�J&"`,Cr��"�d�9�s�J+:�"1���a�����1�� ��&�u�~ 8Y�w�\;Ϸ-D�A7�X��N.� 431 0 obj
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Added HCPCS code Q5102 to coding section. Injection, eculizumab, 10 mg. PERJETA Sample Coding. For the administration of a … Q�h6�S 383 0 obj
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Use this page to view details for the Local Coverage Article for billing and coding: eculizumab; soliris -j1300.
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