See Important Safety Information, including Boxed Warning, and full Prescribing Information. These tables are provided for informational purposes only. For the drugs that are administered IV the CPT codes for IV injection/infusion should be used codes 96365-96368 and 96374-96375. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early. ULTOMIRIS Coding & Billing Guide in PNH DOWNLOAD. "y��l-��G0[H2&�!� �H�_��`6�Pf�$����s C�0 VI. PERJETA Sample Coding. per Administration HCPCS Code Maximum Allowed Brand Generic Soliris eculizumab aHUS 1200 mg J1300 120 HCPCS units (10 mg per unit) MG/NMOSD 1200 mg J1300 120 HCPCS units (10 mg per unit) PNH 900 mg J1300 90 HCPCS units (10 mg per unit) HCPCS Code Based Maximum Dosage Information h�bbd```b``�"W�H�o ��X|*X�,�D���H�zV+��&X� �d�V�e��&4�Eb��ȁH�z�?D���`���)�I0 The Soliris admixture should be administered by intravenous infusion over 35 minutes via gravity feed, a syringe-type pump, or an infusion pump. Listing of a code in this policy does not imply that the service is covered and is not a guarantee of payment. a The mean (SD) terminal elimination half-life and clearance of ravulizumab-cwvz in patients with PNH are 49.7 (8.9) days and 0.08 (0.022) L/day, respectively. There are 0 new musculoskeletal CPT codes added with 0 deletions and 2 major revisions along with an extensive update to arthroscopic loose body removal requirements. J1300. If an adverse reaction occurs during the administration of Soliris… Drugs administered other than oral method, chemotherapy drugs. 383 0 obj <>/Filter/FlateDecode/ID[<2E9928000B8EBF4096C6B1771E7E9D5E>]/Index[366 66]/Info 365 0 R/Length 88/Prev 89526/Root 367 0 R/Size 432/Type/XRef/W[1 2 1]>>stream Policy section and coding updated with Soliris. z �( � ���c�Qr/�/=�A����>�[z�nI�(�� �a�����^�[z�nIG9�ٽ0x�����r$'{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���}>+����! For questions concerning the technical Half-life of eculizumab is 11.25-17.25 days. endstream endobj startxref J1300 is a valid 2021 HCPCS code for Injection, eculizumab, 10 mg or just “ Eculizumab injection ” for short, used in Medical care . 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. 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. Coding. Boston, MA; Alexion … ***Note: This Medical Policy is complex and technical. J1300 has been in effect since 01/01/2008. * *PLEASE NOTE NEW ALPHA NUMERIC CHDP PROGRAM SERVICE CODES. 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 Soliris Policy: Drug Policy (Effective 10/01/2014) 1 ... APPLICABLE CODES..... 6. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). %PDF-1.5 %���� 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. c'�{B¥��D ���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 CPT Jcode - J0850, J1459, J1561, J1568, J2788 - Intravenous Immune Globulin (IVIG) 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 HCPCS 631 0 obj <> endobj Under the Soliris REMS, prescribers must enroll in the program. VI. Visit Anthem.com to learn more about how these policies are used to determine patient coverage and medical necessity. Injection, eculizumab, 10 mg. 06/20/17 Minor edit. 0 *Note: for Soliris switch therapy please refer to the package insert for appropriate switch dosing. Paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis Source: Alexion Pharmaceuticals, 2019a. 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 indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. Dosing information for Soliris® (eculizumab). %%EOF Other policies and coverage guidelines may apply. ��#�a��~��2`h�0�Ql?J�U�.Ą _4�z(�( �n~�ӓj9ϗ釄�y�n�(�Kߥ��u>�oaO'6��M��P��J$����i�|��W�2/넦��kT�cQ��8.˪~��C0�A��� ����F1ؽ0k�*D=|#�a0� 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. endstream endobj startxref Q�h6�S Admixed solutions of Soliris are stable for 24 hours at 2-8° C (36-46° F) and at room temperature. Dosage and Administration Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines. 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). �!Ks����BA`�p�`F x0�@CL��&Q��t++� �h�44Xb� X��� �1 SOLIRIS is a medicine that affects your immune system. [���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.� Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com. PROCEDURES AND BILLING CODES To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Added “Aria” to Simponi to designate IV formulation. Medi-Cal Code Medi-Cal Description Age Group CHDP Code CHDP Description Reimbursement 90620 Bexsero® 10 years through 18 years 11 months* M1 VFC $9 CPT Code 90620 (2-dose schedule) and meningococcal recombinant lipoprotein vaccine, Trumenba®, CPT Code 90621 (3-dose schedule). SOLIRIS is only available through a program called the SOLIRIS REMS. Medical policies and clinical utilization management guidelines help us determine if a procedure is medically necessary. 0 666 0 obj <>/Filter/FlateDecode/ID[<2110C510EF60944CB2F00F02C3A2A744>]/Index[631 88]/Info 630 0 R/Length 144/Prev 172762/Root 632 0 R/Size 719/Type/XRef/W[1 3 1]>>stream GR-68742 (11-20) Page 1 of 2 Soliris® (eculizumab) Injectable Medication Precertification Request Aetna Precertification Notification Phone: 1-866-752-7021 . Administer Soliris at the recommended dosage regimen time points, or within two days of these time points. 431 0 obj <>stream For the administration of a … Background U.S. Food and Drug Administration (FDA)-Approved Indications. HCPCS Code. 3�Vb%�H(?��Z���#E'{槌+D7�f89�;�:��p�/�R��d�����)+����%J��gK�㏀�E��)CH320�� i1��" ���e&� -��4�Dc'@� a�K� Eculizumab (Soliris®) On June 27, 2019, The U.S. Food and Drug Administration approved Eculizumab (Soliris®) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. 718 0 obj <>stream h��[mo�F�+�r@���}9l�NԮa9��F�JtLT& �n�3�]jIS�#]�8!��rwv�ٗy8�܈�$�ȄR�J�P�k�I$1P�D ��$њAMK`ܲ�.��A�†H(�8*���@���:���l�P���� �R%�hh Added Renflexis to coverage criteria and to the coding section. 03/01/17 Annual Review, approved February 14, 2017. 366 0 obj <> endobj 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. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). FAX: 1-888-267-3277 Added HCPCS code Q5102 to coding section. 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� Under the Soliris REMS, prescribers must enroll in the program. RECENT MAJOR CHANGES . See Important Safety Information, including Boxed Warning, and full Prescribing Information. References 1. 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. Use this page to view details for the Local Coverage Article for billing and coding: eculizumab; soliris -j1300. This coding information may assist you as you complete the payer forms for PERJETA. 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. h�bbd``b`6S�� ��$X}AI@��'��ⶃX�@,C�� �$����/KH��``bd�2��q��O^0 �4 � Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). – 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) Soliris [package insert]. SOLIRIS can lower the ability of your immune system to fight infections. 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 Soliris® (eculizumab) treats anti-AChR antibody-positive gMG. %%EOF 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 Generic Name Trade Name … Instead, the administration of the following drugs in their subcutaneous or intramuscular forms should be billed using CPT code 96372. �# 6b�m1@�q�M����. %PDF-1.5 %���� Description. 09/01/17 Interim Review, approved August 15, 2017. 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�'� endstream endobj 632 0 obj <. Under the Soliris REMS , prescribers must enroll in the program (5.2). 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. Code Description HCPCS .