HLS 23RS-728 ORIGINAL 2023 Regular Session HOUSE BILL NO. 435 BY REPRESENTATIVE FREEMAN Prefiled pursuant to Article III, Section 2(A)(4)(b)(i) of the Constitution of Louisiana. MEDICAID: Provides relative to medicaid coverage of chimeric antigen receptor T-cell therapy 1 AN ACT 2To enact Part VII of Chapter 5-E of Title 40 of the Louisiana Revised Statutes of 1950, to 3 be comprised of R.S. 40:1258.1 and 1258.2, relative to Medicaid coverage for 4 chimeric antigen receptor T-cell therapy; to provide for definitions; to require certain 5 healthcare facilities to determine eligibility for and provide chimeric antigen receptor 6 T-cell therapy; to establish requirements for enrollment eligibility; to require the 7 Louisiana Department of Health to perform certain duties relative to Medicaid 8 coverage for such treatment; and to provide for related matters. 9Be it enacted by the Legislature of Louisiana: 10 Section 1. Part VII of Chapter 5-E of Title 40 of the Louisiana Revised Statutes of 111950, comprised of R.S. 40:1258.1 and 1258.2, is hereby enacted to read as follows: 12 PART VII. CHIMERIC ANTIGEN RECEPTOR T-CELL THERAPY 13 §1258.1. Definitions 14 As used in this Part, the following terms have the meanings ascribed to them 15 in this Section: 16 (1) "Chimeric antigen receptor (CAR) T-cell therapy" means a treatment that 17 is designed to manipulate T-cell protein to recognize an antigen on targeted tumor 18 cells in an effort to eliminate cancer. 19 (2) "Healthcare facility" has the same meaning as the term is defined in R.S. 20 40:2120.13. Page 1 of 4 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 23RS-728 ORIGINAL HB NO. 435 1 §1258.2. Medicaid coverage; enrollment qualifications; duties 2 A. The Louisiana Medicaid program shall cover inpatient and, if deemed 3 appropriate, outpatient coverage of CAR T-cell therapy when such therapy is 4 approved by the United States Food and Drug Administration, used for a medically 5 accepted indication, and administered in any healthcare facility appropriately 6 providing CAR T-cell therapy in accordance with state and federal guidelines or 7 certifications. 8 B. Any healthcare facility appropriately providing CAR T-cell therapy in 9 accordance with state and federal guidelines or certifications that participates in the 10 Louisiana Medicaid program shall provide CAR T-cell therapy to an individual who 11 is eligible for such enrollment as defined in Subsection C of this Section. 12 C.(1) In order to receive coverage from the Louisiana Medicaid program for 13 CAR T-cell therapy, the eligibility of a prospective enrollee shall be determined by 14 the healthcare facility appropriately providing CAR T-cell therapy in accordance 15 with state and federal guidelines or certifications as provided in Subsection B of this 16 Section. 17 (2) A prospective enrollee shall be considered eligible for CAR T-cell 18 therapy enrollment if the individual satisfies all of the following qualifications: 19 (a) The individual is enrolled in the Louisiana Medicaid program. 20 (b) A licensed healthcare provider has certified that CAR T-cell therapy is 21 medically necessary and appropriate to treat the individual's condition. 22 (c) The CAR T-cell therapy is administered in any healthcare facility 23 appropriately providing CAR T-cell therapy in accordance with state and federal 24 guidelines or certifications. 25 D. Pursuant to this Section, the secretary of the Louisiana Department of 26 Health shall do all of the following: 27 (1) Submit to the Centers for Medicare and Medicaid Services all necessary 28 state plan amendments. Page 2 of 4 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 23RS-728 ORIGINAL HB NO. 435 1 (2) Promulgate all necessary rules and regulations in accordance with the 2 Administrative Procedure Act. 3 (3) Promulgate rules as necessary to regulate high cost pharmaceutical carve- 4 outs. 5 (4) Take any other actions necessary to implement the provisions of this 6 Section. DIGEST The digest printed below was prepared by House Legislative Services. It constitutes no part of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)] HB 435 Original 2023 Regular Session Freeman Abstract: Provides Medicaid coverage for chimeric antigen receptor (CAR) T-cell therapy. Proposed law defines "chimeric antigen receptor (CAR) T-cell therapy" and provides the definition of "healthcare facility" as provided in present law. Proposed law requires the Louisiana Medicaid program to provide inpatient and, if appropriate, outpatient coverage for CAR T-cell therapy when such therapy has been approved by the U.S. Food and Drug Administration, is used for a medically accepted indication, and is administered in a healthcare facility appropriately providing CAR T-cell therapy in accordance with state and federal guidelines or certifications. Proposed law requires a healthcare facility appropriately providing CAR T-cell therapy in accordance with state and federal guidelines or certifications to participate in the Louisiana Medicaid program to provide CAR T-cell therapy to eligible enrollees, as defined in proposed law. Proposed law requires a healthcare facility appropriately providing CAR T-cell therapy in accordance with state and federal guidelines or certifications to make a determination of a prospective enrollee's eligibility for CAR T-cell therapy enrollment. Proposed law establishes the following requirements for a prospective enrollee to be considered eligible for CAR T-cell therapy enrollment: (1) The individual is enrolled in the Louisiana Medicaid program. (2)A licensed healthcare provider has certified that CAR T-cell therapy is medically necessary and appropriate to treat the individual's condition. (3)The CAR T-cell therapy is administered in a healthcare facility appropriately providing CAR T-cell therapy in accordance with state and federal guidelines or certifications. Proposed law requires the secretary of the La. Dept. of Health to do the following: (1) Submit to the Centers for Medicare and Medicaid Services all necessary state plan amendments. Page 3 of 4 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 23RS-728 ORIGINAL HB NO. 435 (2) Promulgate all necessary rules and regulations in accordance with present law. (3)Promulgate rules as necessary to regulate high cost pharmaceutical carve-outs. (4)Take any other actions necessary to implement the provisions of proposed law. (Adds R.S. 40:1258.1 and 1258.2) Page 4 of 4 CODING: Words in struck through type are deletions from existing law; words underscored are additions.