SOLIRIS can lower the ability of your immune system to fight infections. SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. Soliris Policy: Drug Policy (Effective 10/01/2014) 1 ... APPLICABLE CODES..... 6. �!Ks����BA`�p�`F x0�@CL��&Q��t++� �h�44Xb� X��� �1 VI. HCPCS Code. ��#�a��~��2`h�0�Ql?J�U�.Ą _4�z(�( Source: Alexion Pharmaceuticals, 2019a. 0 CPT Jcode - J0850, J1459, J1561, J1568, J2788 - Intravenous Immune Globulin (IVIG) 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. 06/20/17 Minor edit. Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com. endstream endobj startxref For the drugs that are administered IV the CPT codes for IV injection/infusion should be used codes 96365-96368 and 96374-96375. Policy section and coding updated with Soliris. Administer Soliris at the recommended dosage regimen time points, or within two days of these time points. Medical policies and clinical utilization management guidelines help us determine if a procedure is medically necessary. 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. GR-68742 (11-20) Page 1 of 2 Soliris® (eculizumab) Injectable Medication Precertification Request Aetna Precertification Notification Phone: 1-866-752-7021 . CPT Code 90620 (2-dose schedule) and meningococcal recombinant lipoprotein vaccine, Trumenba®, CPT Code 90621 (3-dose schedule). 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. *Note: for Soliris switch therapy please refer to the package insert for appropriate switch dosing. Listing of a code in this policy does not imply that the service is covered and is not a guarantee of payment. 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 endobj 632 0 obj <. 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. RECENT MAJOR CHANGES . c'�{B¥��D Coding. Soliris [package insert]. 6b�m1@�q�M����. HCPCS Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 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 718 0 obj <>stream 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). Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. 0 Other policies and coverage guidelines may apply. 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. ULTOMIRIS Coding & Billing Guide in PNH DOWNLOAD. %%EOF J1300 is a valid 2021 HCPCS code for Injection, eculizumab, 10 mg or just “ Eculizumab injection ” for short, used in Medical care . These tables are provided for informational purposes only. See Important Safety Information, including Boxed Warning, and full Prescribing Information. endstream endobj startxref �n~�ӓj9ϗ釄�y�n�(�Kߥ��u>�oaO'6��M��P��J$����i�|��W�2/넦��kT�cQ��8.˪~��C0�A��� ����F1ؽ0k�*D=|#�a0� 431 0 obj <>stream Background U.S. Food and Drug Administration (FDA)-Approved Indications. SOLIRIS is a medicine that affects your immune system. �# Visit Anthem.com to learn more about how these policies are used to determine patient coverage and medical necessity. endstream endobj 367 0 obj <>/Metadata 27 0 R/Outlines 49 0 R/PageLayout/OneColumn/Pages 364 0 R/StructTreeRoot 52 0 R/Type/Catalog>> endobj 368 0 obj <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 0/Type/Page>> endobj 369 0 obj <>stream Code Maximum Allowed Brand Generic Soliris eculizumab aHUS 300 mg vials 25682-0001-01 4 vials/120 ml MG/NMOSD 300 mg vials 25682-0001-01 4 vials/120ml PNH 300 mg vials 25682-0001-01 3 vials/90ml Ultomiris ravulizumab-cwvz - 300 mg/30 mL solution in vials 25682-0022-01 360 mL 383 0 obj <>/Filter/FlateDecode/ID[<2E9928000B8EBF4096C6B1771E7E9D5E>]/Index[366 66]/Info 365 0 R/Length 88/Prev 89526/Root 367 0 R/Size 432/Type/XRef/W[1 2 1]>>stream VI. Use this page to view details for the Local Coverage Article for billing and coding: eculizumab; soliris -j1300. Under the Soliris REMS, prescribers must enroll in the program. h�bbd``b`6S�� ��$X}AI@��'��ⶃX�@,C�� �$����/KH��``bd�2��q��O^0 �4 � Boston, MA; Alexion … Billing Code/Availability Information HCPCS code: J1300 – Injection, eculizumab, 10 mg; 1 billable unit = 10 mg NDC: Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. Indications and Usage (1.3) 10/2017 Dosage and Administration (2.4, 2.5) 10/2017 Dosage and Administration (2.5, 2.6, 2.7) 07/2018 h�bbd```b``�"W�H�o ��X|*X�,�D���H�zV+��&X� �d�V�e��&4�Eb��ȁH�z�?D���`���)�I0 z �( � ���c�Qr/�/=�A����>�[z�nI�(�� �a�����^�[z�nIG9�ٽ0x�����r$'{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���}>+����! – 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) 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. Code Description HCPCS . Injection, eculizumab, 10 mg. %PDF-1.5 %���� Dosage and Administration Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines. Dosing information for Soliris® (eculizumab). 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. This coding information may assist you as you complete the payer forms for PERJETA. 09/01/17 Interim Review, approved August 15, 2017. If an adverse reaction occurs during the administration of Soliris… 666 0 obj <>/Filter/FlateDecode/ID[<2110C510EF60944CB2F00F02C3A2A744>]/Index[631 88]/Info 630 0 R/Length 144/Prev 172762/Root 632 0 R/Size 719/Type/XRef/W[1 3 1]>>stream For questions concerning the technical Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 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. h�b```��,�� ��ea���"��F������P�J��:������6��ڸZ�6p4p4t r4�+QF�H �6���$�?DX�h�T�"���sG�����Q`}b�&�@ʁ�-�30��@�e 9��#��e`�v�(cL0 4�'� Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Added Renflexis to coverage criteria and to the coding section. Added “Aria” to Simponi to designate IV formulation. 366 0 obj <> endobj Drugs administered other than oral method, chemotherapy drugs. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early. There are 0 new musculoskeletal CPT codes added with 0 deletions and 2 major revisions along with an extensive update to arthroscopic loose body removal requirements. per Administration HCPCS Code Maximum Allowed Brand Generic Soliris eculizumab aHUS 1200 mg J1300 120 HCPCS units (10 mg per unit) MG/NMOSD 1200 mg J1300 120 HCPCS units (10 mg per unit) PNH 900 mg J1300 90 HCPCS units (10 mg per unit) HCPCS Code Based Maximum Dosage Information Generic Name Trade Name … FAX: 1-888-267-3277 See Important Safety Information, including Boxed Warning, and full Prescribing Information. The Soliris admixture should be administered by intravenous infusion over 35 minutes via gravity feed, a syringe-type pump, or an infusion pump. 03/01/17 Annual Review, approved February 14, 2017. 3�Vb%�H(?��Z���#E'{槌+D7�f89�;�:��p�/�R��d�����)+����%J��gK�㏀�E��)CH320�� i1��" ���e&� -��4�Dc'@� a�K� Eculizumab (Soliris®) On June 27, 2019, The U.S. Food and Drug Administration approved Eculizumab (Soliris®) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. %PDF-1.5 %���� Soliris® (eculizumab) treats anti-AChR antibody-positive gMG. h��[mo�F�+�r@���}9l�NԮa9��F�JtLT& �n�3�]jIS�#]�8!��rwv�ٗy8�܈�$�ȄR�J�P�k�I$1P�D ��$њAMK`ܲ�.��A�H(�8*���@���:���l�P���� �R%�hh Under the Soliris REMS, prescribers must enroll in the program. Medi-Cal Code Medi-Cal Description Age Group CHDP Code CHDP Description Reimbursement 90620 Bexsero® 10 years through 18 years 11 months* M1 VFC $9 For the administration of a … J1300 has been in effect since 01/01/2008. "y��l-��G0[H2&�!� �H�_��`6�Pf�$����s C�0 ***Note: This Medical Policy is complex and technical. Q�h6�S Instead, the administration of the following drugs in their subcutaneous or intramuscular forms should be billed using CPT code 96372. J1300. Added HCPCS code Q5102 to coding section. References 1. Half-life of eculizumab is 11.25-17.25 days. ���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 Under the Soliris REMS , prescribers must enroll in the program (5.2). 631 0 obj <> endobj * *PLEASE NOTE NEW ALPHA NUMERIC CHDP PROGRAM SERVICE CODES. %%EOF PROCEDURES AND BILLING CODES To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, [���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.� PERJETA Sample Coding. Description. Admixed solutions of Soliris are stable for 24 hours at 2-8° C (36-46° F) and at room temperature. Paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis 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). SOLIRIS is only available through a program called the SOLIRIS REMS.
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