SF 3271

Introduction - 94th Legislature (2025 - 2026)

Posted on 04/04/2025 09:38 a.m.

A bill for an act
relating to health; authorizing independent audits of 340B entity reporting by
nonprofit public interest organizations; requiring revenue from prescription drugs
obtained under the 340B program to be used for charity care; authorizing
enforcement by the attorney general; amending Minnesota Statutes 2024, section
62J.461, subdivision 1, by adding a subdivision; proposing coding for new law in
Minnesota Statutes, chapter 144.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2024, section 62J.461, subdivision 1, is amended to read:

Subdivision 1.

Definitions.

(a) For purposes of this section, the following definitions
apply.

(b) "340B covered entity" or "covered entity" means a covered entity as defined in United
States Code, title 42, section 256b(a)(4), with a service address in Minnesota as of January
1 of the reporting year. 340B covered entity includes all entity types and grantees. All
facilities that are identified as child sites or grantee associated sites under the federal 340B
Drug Pricing Program are considered part of the 340B covered entity.

(c) "340B Drug Pricing Program" or "340B program" means the drug discount program
established under United States Code, title 42, section 256b.

(d) "340B entity type" is the designation of the 340B covered entity according to the
entity types specified in United States Code, title 42, section 256b(a)(4).

(e) "340B ID" is the unique identification number provided by the Health Resources
and Services Administration to identify a 340B-eligible entity in the 340B Office of Pharmacy
Affairs Information System.

(f) "Contract pharmacy" means a pharmacy with which a 340B covered entity has an
arrangement to dispense drugs purchased under the 340B Drug Pricing Program.

new text begin (g) "Nonprofit public interest organization" means an organization operating pursuant
to chapter 317A, experienced in financial or legal review, and with a purpose that includes
the promotion of health care in Minnesota. Nonprofit public interest organization does not
include a 340B covered entity and an affiliate of a 340B covered entity.
new text end

deleted text begin (g) deleted text end new text begin (h) new text end "Pricing unit" means the smallest dispensable amount of a prescription drug
product that can be dispensed or administered.

Sec. 2.

Minnesota Statutes 2024, section 62J.461, is amended by adding a subdivision to
read:

new text begin Subd. 3a. new text end

new text begin Independent audit. new text end

new text begin (a) Nonprofit public interest organizations may audit
340B covered entities to determine compliance with this section and section 144.5875.
new text end

new text begin (b) 340B covered entities must cooperate with a nonprofit public interest organization
conducting an audit under this section and must provide all necessary data, documents, and
other information, regardless of classification, that the nonprofit public interest organization
requests to conduct an audit. A 340B covered entity is not required to provide any data,
documents, or other information if the information is unnecessary for the completion of the
audit under this section.
new text end

new text begin (c) Nonprofit public interest organizations must maintain all data, documents, and other
information obtained pursuant to this section as confidential information and are prohibited
from disclosing information to a third party. A nonprofit public interest organization may
report audit results and provide recommendations to the chairs and ranking minority members
of the legislative committees with jurisdiction over health and human services policy and
finance.
new text end

Sec. 3.

new text begin [144.5875] 340B REVENUE FOR CHARITY CARE.
new text end

new text begin Subdivision 1. new text end

new text begin Mandatory use of 340B revenue. new text end

new text begin A 340B covered entity, as defined in
section 62J.461, must annually expend 25 percent of the 340B covered entity's 340B net
revenue, as calculated under section 62J.461, on the provision of charity care, as defined
in section 144.587. Medical debt write-offs and community service do not apply toward the
required charity care expenditures required under this subdivision.
new text end

new text begin Subd. 2. new text end

new text begin Enforcement. new text end

new text begin In addition to the enforcement of this section by the
commissioner, the attorney general may enforce this section under section 8.31.
new text end