*ES0118.2* Reprinted April 1, 2025 ENGROSSED SENATE BILL No. 118 _____ DIGEST OF SB 118 (Updated March 31, 2025 3:53 pm - DI 147) Citations Affected: IC 16-18; IC 16-40. Synopsis: 340B drug program report. Requires certain entities authorized to participate in the federal 340B Drug Pricing Program to annually report specified data to the Indiana department of health (state department). Requires the state department to submit a report of the aggregated data to the legislative council and post the report on the state department's website. Effective: July 1, 2025. Charbonneau, Crider, Johnson T, Deery, Becker, Busch (HOUSE SPONSORS — BARRETT, MCGUIRE, ISA) January 8, 2025, read first time and referred to Committee on Health and Provider Services. January 29, 2025, amended, reported favorably — Do Pass. February 3, 2025, read second time, ordered engrossed. Engrossed. February 4, 2025, read third time, passed. Yeas 49, nays 1. HOUSE ACTION March 3, 2025, read first time and referred to Committee on Public Health. March 25, 2025, amended, reported — Do Pass. March 31, 2025, read second time, amended, ordered engrossed. ES 118—LS 6292/DI 104 Reprinted April 1, 2025 First Regular Session of the 124th General Assembly (2025) PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana Constitution) is being amended, the text of the existing provision will appear in this style type, additions will appear in this style type, and deletions will appear in this style type. Additions: Whenever a new statutory provision is being enacted (or a new constitutional provision adopted), the text of the new provision will appear in this style type. Also, the word NEW will appear in that style type in the introductory clause of each SECTION that adds a new provision to the Indiana Code or the Indiana Constitution. Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts between statutes enacted by the 2024 Regular Session of the General Assembly. ENGROSSED SENATE BILL No. 118 A BILL FOR AN ACT to amend the Indiana Code concerning health. Be it enacted by the General Assembly of the State of Indiana: 1 SECTION 1. IC 16-18-2-0.2 IS ADDED TO THE INDIANA CODE 2 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 3 1, 2025]: Sec. 0.2. "340B covered entity", for purposes of 4 IC 16-40-6, has the meaning set forth in IC 16-40-6-1. 5 SECTION 2. IC 16-18-2-0.3 IS ADDED TO THE INDIANA CODE 6 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 7 1, 2025]: Sec. 0.3. "340B program", for purposes of IC 16-40-6, has 8 the meaning set forth in IC 16-40-6-2. 9 SECTION 3. IC 16-18-2-52.5 IS AMENDED TO READ AS 10 FOLLOWS [EFFECTIVE JULY 1, 2025]: Sec. 52.5. (a) "Charity care", 11 for purposes of IC 16-21-6, and IC 16-21-9, and IC 16-40-6, means the 12 unreimbursed cost to a hospital of providing, funding, or otherwise 13 financially supporting health care services: 14 (1) to a person classified by the hospital as financially indigent or 15 medically indigent on an inpatient or outpatient basis; and 16 (2) to financially indigent patients through other nonprofit or 17 public outpatient clinics, hospitals, or health care organizations. ES 118—LS 6292/DI 104 2 1 (b) As used in this section, "financially indigent" means an 2 uninsured or underinsured person who is accepted for care with no 3 obligation or a discounted obligation to pay for the services rendered 4 based on the hospital's financial criteria and procedure used to 5 determine if a patient is eligible for charity care. The criteria and 6 procedure must include income levels and means testing indexed to the 7 federal poverty guidelines. A hospital may determine that a person is 8 financially or medically indigent under the hospital's eligibility system 9 after health care services are provided. 10 (c) As used in this section, "medically indigent" means a person 11 whose medical or hospital bills after payment by third party payors 12 exceed a specified percentage of the patient's annual gross income as 13 determined in accordance with the hospital's eligibility system, and 14 who is financially unable to pay the remaining bill. 15 SECTION 4. IC 16-40-6 IS ADDED TO THE INDIANA CODE AS 16 A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE JULY 17 1, 2025]: 18 Chapter 6. 340B Drug Pricing Program Reporting 19 Sec. 1. (a) As used in this chapter, "340B covered entity" means 20 an entity described in 42 U.S.C. 256b(a)(4)(L) through 42 U.S.C. 21 256b(a)(4)(O) that: 22 (1) is authorized to participate in the federal 340B Drug 23 Pricing Program under Section 340B of the federal Public 24 Health Service Act (42 U.S.C. 256b(a)(4)); and 25 (2) has a service address in Indiana as of January 1 of the 26 reporting year. 27 (b) The term does not include an entity that is a recipient of a 28 grant from the federal Health Resources and Services 29 Administration. 30 Sec. 2. As used in this chapter, "340B program" refers to the 31 federal 340B Drug Pricing Program established under 42 U.S.C. 32 256b. 33 Sec. 3. (a) Before April 1 of each year, a 340B covered entity 34 shall report the following information and transactions to the state 35 department concerning the 340B covered entity's participation in 36 or participation on behalf of the 340B covered entity in the federal 37 340B program for the previous calendar year: 38 (1) The: 39 (A) name; 40 (B) service address; 41 (C) 340B program identification number; and 42 (D) designation of entity type, as specified in 42 U.S.C. ES 118—LS 6292/DI 104 3 1 256b(a)(4); 2 of the 340B covered entity. 3 (2) The aggregate acquisition cost for all prescription drugs 4 obtained under the 340B program and dispensed or 5 administered to patients. 6 (3) The aggregate payment amount received for all drugs 7 obtained under the 340B program and dispensed or 8 administered to patients. 9 (4) The aggregate payment made to pharmacies under 10 contract to dispense drugs obtained under the 340B program. 11 (5) The number of claims for prescription drugs described in 12 subdivision (3). 13 (6) How the 340B covered entity uses any savings from 14 participating in the 340B program, including the amount of 15 savings used for the provision of charity care, community 16 benefits, or a similar program of providing unreimbursed or 17 subsidized health care. 18 (7) The aggregate payments made to any other entity that is 19 not a 340B covered entity and is not a contract pharmacy as 20 described in subdivision (4) for managing any aspect of the 21 340B covered entity's 340B program. 22 (8) The aggregate payment made for any other administering 23 expense for the 340B program. 24 (9) The aggregate number of prescription drugs dispensed or 25 administered to patients for which a payment was reported 26 under subdivision (3). 27 (10) The percentage of the 340B covered entity's claims that 28 were for prescription drugs obtained under the 340B 29 program. 30 (11) The number and percentage of low income patients of the 31 340B covered entity that were served by a sliding fee scale for 32 a prescription drug dispensed or administered under the 340B 33 program. 34 (12) The 340B covered entity's total operating costs. 35 (13) The 340B covered entity's total costs for charity care. 36 (14) A copy of the 340B covered entity's financial assistance 37 policy for the reporting year. 38 (b) The information required to be reported under subsection 39 (a)(3) through (a)(5) must, to the extent feasible, be reported by 40 payer type, including the following: 41 (1) Commercial. 42 (2) Medicaid. ES 118—LS 6292/DI 104 4 1 (3) Medicare. 2 (4) Uninsured. 3 (c) The data submitted in the reports required under subsection 4 (a) is confidential and is not available for public inspection. 5 (d) Before November 15 of each year, the state department shall 6 prepare a report that aggregates the data submitted under 7 subsection (a) and: 8 (1) submit the report to the legislative council in an electronic 9 format under IC 5-14-6; and 10 (2) post the report on the state department's website. 11 Sec. 4. A 340B covered entity that fails to provide the 12 information required under section 3 of this chapter by the date 13 required shall pay to the state department a fine of one thousand 14 dollars ($1,000) per day for which the information is past due. ES 118—LS 6292/DI 104 5 COMMITTEE REPORT Mr. President: The Senate Committee on Health and Provider Services, to which was referred Senate Bill No. 118, has had the same under consideration and begs leave to report the same back to the Senate with the recommendation that said bill be AMENDED as follows: Page 1, between lines 4 and 5, begin a new paragraph and insert: "SECTION 2. IC 16-18-2-0.3 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2025]: Sec. 0.3. "340B program", for purposes of IC 16-40-6, has the meaning set forth in IC 16-40-6-2.". Page 2, delete lines 11 through 14. Page 2, line 19, after "1." insert "(a)". Page 2, line 22, delete "and includes any pharmacy" and insert "and that has a service address in Indiana as of January 1 of the reporting year. (b) The term includes all entity types and grantees, including a facility that is identified as a child site or grantee associated site under the 340B program. Sec. 2. As used in this chapter, "340B program" refers to the federal 340B Drug Pricing Program established under 42 U.S.C. 256b.". Page 2, delete lines 23 through 24. Page 2, line 25, delete "2." and insert "3.". Page 2, line 26, after "information" insert "and transactions". Page 2, line 27, after "in" insert "or participation on behalf of the 340B covered entity in". Page 2, line 28, delete "Drug Pricing Program" and insert "program". Page 2, delete line 29, begin a new line block indented and insert: "(1) The: (A) name; (B) service address; (C) 340B program identification number; and (D) designation of entity type, as specified in 42 U.S.C. 256b(a)(4); of the 340B covered entity.". Page 2, line 30, after "for" insert "all". Page 2, line 32, after "for" insert "all". Page 2, line 33, after "dispensed" insert "or administered". Page 2, after line 42, begin a new line block indented and insert: ES 118—LS 6292/DI 104 6 "(7) The aggregate payments made to any other entity that is not a 340B covered entity and is not a contract pharmacy as described in subdivision (4) for managing any aspect of the 340B covered entity's 340B program. (8) The aggregate payment made for any other administering expense for the 340B program. (9) The aggregate number of prescription drugs administered or dispensed to patients for which a payment was reported under subdivision (3). (10) The percentage of the 340B covered entity's claims that were for prescription drugs obtained under the 340B program. (11) The number and percentage of low income patients of the 340B covered entity that were served by a sliding fee scale for a prescription drug dispensed or administered under the 340B program. (12) The 340B covered entity's total operating costs. (13) The 340B covered entity's total costs for charity care. (14) A copy of the 340B covered entity's financial assistance policy for the reporting year.". Page 3, between lines 5 and 6, begin a new line block indented and insert: "(4) Uninsured.". Page 3, after line 13, begin a new paragraph and insert: "SECTION 5. IC 27-1-44.5-11.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2025]: Sec. 11.5. (a) The following must submit information to the data base concerning prescription drug prices: (1) A health payer, using patient data claims. (2) A pharmacy. (3) A nonprofit hospital pharmacy. (4) A 340B covered entity (as defined in IC 16-40-6-1).". Renumber all SECTIONS consecutively. and when so amended that said bill do pass. (Reference is to SB 118 as introduced.) CHARBONNEAU, Chairperson Committee Vote: Yeas 11, Nays 0. ES 118—LS 6292/DI 104 7 COMMITTEE REPORT Mr. Speaker: Your Committee on Public Health, to which was referred Senate Bill 118, has had the same under consideration and begs leave to report the same back to the House with the recommendation that said bill be amended as follows: Page 2, line 24, delete "The" and insert "Except as provided in subsection (c), the". Page 2, between lines 26 and 27, begin a new paragraph and insert: "(c) The term does not include the following: (1) An entity that is a recipient of a grant from the federal Health Resources and Services Administration. (2) A federally qualified health center (as defined in 42 U.S.C. 1396d(l)(2)(B)).". Page 3, line 1, after "obtained" insert "through a contract pharmacy". Page 3, line 3, delete "or". Page 3, line 4, delete "administered to patients." and insert "to patients through a contract pharmacy.". Page 3, line 12, after "unreimbursed" insert "or subsidized". Page 3, line 13, delete "care to the indigent." and insert "care.". Page 3, line 20, delete "administered". Page 3, line 21, delete "or". Page 3, delete lines 23 through 29. Page 3, line 30, delete "(12)" and insert "(10)". Page 3, line 31, delete "(13)" and insert "(11)". Page 3, line 32, delete "(14)" and insert "(12)". Page 3, line 35, delete "(a) must" and insert "(a)(3) through (a)(5) must, to the extent feasible,". Page 4, delete lines 6 through 14. and when so amended that said bill do pass. (Reference is to SB 118 as printed January 30, 2025.) BARRETT Committee Vote: yeas 11, nays 0. ES 118—LS 6292/DI 104 8 HOUSE MOTION Mr. Speaker: I move that Engrossed Senate Bill 118 be amended to read as follows: Page 2, delete lines 19 through 31, begin a new paragraph and insert: "Sec. 1. (a) As used in this chapter, "340B covered entity" means an entity described in 42 U.S.C. 256b(a)(4)(L) through 42 U.S.C. 256b(a)(4)(O) that: (1) is authorized to participate in the federal 340B Drug Pricing Program under Section 340B of the federal Public Health Service Act (42 U.S.C. 256b(a)(4)); and (2) has a service address in Indiana as of January 1 of the reporting year. (b) The term does not include an entity that is a recipient of a grant from the federal Health Resources and Services Administration.". Page 3, line 6, delete "through a contract pharmacy". Page 3, line 7, delete "program." and insert "program and dispensed or administered to patients.". Page 3, line 9, delete "to patients" and insert "or administered to patients.". Page 3, delete line 10. Page 3, line 26, after "dispensed" insert "or administered". Page 3, between lines 28 and 29, begin a new line block indented and insert: "(10) The percentage of the 340B covered entity's claims that were for prescription drugs obtained under the 340B program. (11) The number and percentage of low income patients of the 340B covered entity that were served by a sliding fee scale for a prescription drug dispensed or administered under the 340B program.". Page 3, line 29, delete "(10)" and insert "(12)". Page 3, line 30, delete "(11)" and insert "(13)". Page 3, line 31, delete "(12)" and insert "(14)". Page 4, after line 5, begin a new paragraph and insert: "Sec. 4. A 340B covered entity that fails to provide the information required under section 3 of this chapter by the date required shall pay to the state department a fine of one thousand dollars ($1,000) per day for which the information is past due.". ES 118—LS 6292/DI 104 9 (Reference is to ESB 118 as printed March 25, 2025.) MCGUIRE ES 118—LS 6292/DI 104