340B Transparency and Accountability Act
| Model Bill Info | |
|---|---|
| Bill Title | 340B Transparency and Accountability Act |
| Date Introduced | July 17, 2025 |
| Type | Model Policy |
| Status | Draft |
| Task Forces | Health and Human Services |
| Keywords | Health |
340B Transparency and Accountability Act
Section 1 Definitions:
(1) “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:
a. is authorized to participate in the federal 340B Drug Pricing Program under Section 340B of the federal Public Health Service Act; and
b. has a service address in the state of ____________ as of January 1 of the reporting year.
c. The term includes any offsite outpatient facility affiliated under the 340B program with an entity described in subsection
(2) “340B program” refers to the federal 340B Drug Pricing Program established under 42 U.S.C. 256b.
(3) “Charity Care” means the unreimbursed cost to a hospital of providing, funding, or
(4) otherwise financially supporting health care services:
a. to a person classified by the hospital as financially indigent or medically indigent on an inpatient or outpatient basis; and
b. to financially indigent patients through other nonprofit or public outpatient clinics, hospitals, or health care organizations.
(5) 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 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.
(6) 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 2 340B Drug Pricing Program Reporting
(1). 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:
a. The
1. Name
2. Service Address
3. 340B Program Identification Number
4. Designation of entity type, as specified in 42 U.S.C. 256b(a)(4); of the 340B covered entity.
b. The aggregate acquisition cost for all prescription drugs obtained under the 340B program and dispensed or administered to patients.
c. The aggregate payment amount received for all drugs obtained under the 340B program and dispensed or administered to patients.
d. The aggregate payment made to pharmacies under contract to dispense drugs obtained under the 340B program.
e. The number of claims for prescription drugs described in subdivision c.
f. 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.
g. 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 d for managing any aspect of the 340B covered entity’s 340B program.
h. The aggregate payment made for any other administering expense for the 340B program.
i. The aggregate number of prescription drugs dispensed or administered to patients for which a payment was reported under subdivision c.
j. The percentage of the 340B covered entity’s claims that were for prescription drugs obtained under the 340B program.
k. 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.
l. The 340B covered entity’s total operating costs.
m. The 340B covered entity’s total costs for charity care.
n. A copy of the the 340B covered entity’s financial assistance policy for the reporting year.
(2) The information required to be reported under subdivision (1)(c) through 1(e) must, to the extent feasible, be reported by payer type, including the following:
a. Commercial
b. Medicaid
c. Medicare
d. Uninsured
(3) The data submitted in the reports required under subdivision (1) is confidential and is not available for public inspection.
(4) Before November 15 of each year, the state department shall prepare a report that aggregates the data submitted under subdivision (1) and:
a. submit the report to the legislative council in an electronic format
b. post the report on the state department’s website
Section 3 Penalties
(1) A 340B covered entity that fails to provide the information required under 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.