340B drug program report., the official text

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,
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 Additions: Whenever a new statutory provision is being enacted (or a new constitutional
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a new provision to the Indiana Code or the Indiana Constitution.
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between statutes enacted by the 2024 Regular Session of the General Assembly.

  SENATE ENROLLED ACT No. 118

   AN ACT to amend the Indiana Code concerning health.

   Be it enacted by the General Assembly of the State of Indiana:

   SECTION 1. IC 16-18-2-0.2 IS ADDED TO THE INDIANA CODE
AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
1, 2025]: Sec. 0.2. "340B covered entity", for purposes of
IC 16-40-6, has the meaning set forth in IC 16-40-6-1.

   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.

   SECTION 3. IC 16-18-2-52.5 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2025]: Sec. 52.5. (a) "Charity care",
for purposes of IC 16-21-6, and IC 16-21-9, and IC 16-40-6, means the
unreimbursed cost to a hospital of providing, funding, or otherwise
financially supporting health care services:

      (1) to a person classified by the hospital as financially indigent or
      medically indigent on an inpatient or outpatient basis; and
      (2) to financially indigent patients through other nonprofit or
      public outpatient clinics, hospitals, or health care organizations.
   (b) As used in this section, "financially indigent" means an
uninsured or underinsured person who is accepted for care with no
obligation or a discounted obligation to pay for the services rendered
based on the hospital's financial criteria and procedure used to
determine if a patient is eligible for charity care. The criteria and

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procedure must include income levels and means testing indexed to the
federal poverty guidelines. A hospital may determine that a person is
financially or medically indigent under the hospital's eligibility system
after health care services are provided.

   (c) As used in this section, "medically indigent" means a person
whose medical or hospital bills after payment by third party payors
exceed a specified percentage of the patient's annual gross income as
determined in accordance with the hospital's eligibility system, and
who is financially unable to pay the remaining bill.

   SECTION 4. IC 16-40-6 IS ADDED TO THE INDIANA CODE AS
A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE JULY
1, 2025]:

   Chapter 6. 340B Drug Pricing Program Reporting
   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 includes any offsite outpatient facility affiliated
under the 340B program with an entity described in subsection (a).
   Sec. 2. As used in this chapter, "340B program" refers to the
federal 340B Drug Pricing Program established under 42 U.S.C.
256b.
   Sec. 3. (a) Before April 1 of each year, a 340B covered entity
shall report the following information and transactions to the state
department concerning the 340B covered entity's participation in
or participation on behalf of the 340B covered entity in the federal
340B program for the previous calendar year:
      (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.
      (2) The aggregate acquisition cost for all prescription drugs
      obtained under the 340B program and dispensed or
      administered to patients.
      (3) The aggregate payment amount received for all drugs

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      obtained under the 340B program and dispensed or
      administered to patients.
      (4) The aggregate payment made to pharmacies under
      contract to dispense drugs obtained under the 340B program.
      (5) The number of claims for prescription drugs described in
      subdivision (3).
      (6) How the 340B covered entity uses any savings from
      participating in the 340B program, including the amount of
      savings used for the provision of charity care, community
      benefits, or a similar program of providing unreimbursed or
      subsidized health care.
      (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 dispensed or
      administered 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.
   (b) The information required to be reported under subsection
(a)(3) through (a)(5) must, to the extent feasible, be reported by
payer type, including the following:
      (1) Commercial.
      (2) Medicaid.
      (3) Medicare.
      (4) Uninsured.
   (c) The data submitted in the reports required under subsection
(a) is confidential and is not available for public inspection.
   (d) Before November 15 of each year, the state department shall
prepare a report that aggregates the data submitted under

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subsection (a) and:
      (1) submit the report to the legislative council in an electronic
      format under IC 5-14-6; and
      (2) post the report on the state department's website.

   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.

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President of the Senate

President Pro Tempore

Speaker of the House of Representatives

Governor of the State of Indiana

Date:                             Time:

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