HF 4755

as introduced - 93rd Legislature (2023 - 2024) Posted on 03/07/2024 02:43pm

A bill for an act
relating to health; modifying reporting requirements for 340B covered entities;
proposing coding for new law in Minnesota Statutes, chapter 62J; repealing
Minnesota Statutes 2023 Supplement, section 62J.312, subdivision 6.

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

Section 1.

new text begin [62J.461] 340B COVERED ENTITY REPORT.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section, the following definitions
apply.
new text end

new text begin (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.
new text end

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

new text begin (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).
new text end

new text begin (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.
new text end

new text begin (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 end

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

new text begin Subd. 2. new text end

new text begin Current registration. new text end

new text begin Beginning April 1, 2024, each 340B covered entity must
maintain a current registration with the commissioner in a form and manner prescribed by
the commissioner. The registration must include the following information:
new text end

new text begin (1) the name of the 340B covered entity;
new text end

new text begin (2) the 340B ID of the 340B covered entity;
new text end

new text begin (3) the servicing address of the 340B covered entity; and
new text end

new text begin (4) the 340B entity type of the 340B covered entity.
new text end

new text begin Subd. 3. new text end

new text begin Reporting by covered entities to the commissioner. new text end

new text begin (a) Each 340B covered
entity shall report to the commissioner by April 1, 2024, and by April 1 of each year
thereafter, the following information for transactions conducted by the 340B covered entity
or on its behalf, and related to its participation in the federal 340B program for the previous
calendar year:
new text end

new text begin (1) the aggregated acquisition cost for prescription drugs obtained under the 340B
program;
new text end

new text begin (2) the aggregated payment amount received for drugs obtained under the 340B program
and dispensed or administered to patients;
new text end

new text begin (3) the number of pricing units dispensed or administered for prescription drugs described
in clause (2); and
new text end

new text begin (4) the aggregated payments made:
new text end

new text begin (i) to contract pharmacies to dispense drugs obtained under the 340B program;
new text end

new text begin (ii) to any other entity that is not the covered entity and is not a contract pharmacy for
managing any aspect of the covered entity's 340B program; and
new text end

new text begin (iii) for all other expenses related to administering the 340B program.
new text end

new text begin The information under clauses (2) and (3) must be reported by payer type, including but
not limited to commercial insurance, medical assistance, MinnesotaCare, and Medicare, in
the form and manner prescribed by the commissioner.
new text end

new text begin (b) For covered entities that are hospitals, the information required under paragraph (a),
clauses (1) to (3), must also be reported at the national drug code level for the 50 most
frequently dispensed or administered drugs by the facility under the 340B program.
new text end

new text begin (c) Data submitted to the commissioner under paragraphs (a) and (b) are classified as
nonpublic data, as defined in section 13.02, subdivision 9.
new text end

new text begin Subd. 4. new text end

new text begin Enforcement and exceptions. new text end

new text begin (a) Any health care entity subject to reporting
under this section that fails to provide data in the form and manner prescribed by the
commissioner is subject to a fine paid to the commissioner of up to $500 for each day the
data are past due. Any fine levied against the entity under this subdivision is subject to the
contested case and judicial review provisions of sections 14.57 and 14.69.
new text end

new text begin (b) The commissioner may grant an entity an extension of or exemption from the reporting
obligations under this subdivision, upon a showing of good cause by the entity.
new text end

new text begin Subd. 5. new text end

new text begin Reports to the legislature. new text end

new text begin By November 15, 2024, and by November 15 of
each year thereafter, the commissioner shall submit to the chairs and ranking minority
members of the legislative committees with jurisdiction over health care finance and policy,
a report that aggregates the data submitted under subdivision 3, paragraphs (a) and (b). The
data shall be aggregated in a manner that prevents the identification of an individual entity
and any entity's specific data value reported for an individual data element, except that the
following shall be included in the report:
new text end

new text begin (1) the information submitted under subdivision 2; and
new text end

new text begin (2) for each 340B entry identified in subdivision 2, that entity's 340B net revenue as
calculated using the data submitted under subdivision 3, paragraph (a), with net revenue
being subdivision 3, paragraph (a), clause (2), less the sum of subdivision 3, paragraph (a),
clauses (1) and (4).
new text end

Sec. 2. new text begin REPEALER; 340B COVERED ENTITY REPORT.
new text end

new text begin Minnesota Statutes 2023 Supplement, section 62J.312, subdivision 6, new text end new text begin is repealed.
new text end

APPENDIX

Repealed Minnesota Statutes: 24-07437

62J.312 CENTER FOR HEALTH CARE AFFORDABILITY.

Subd. 6.

340B covered entity report.

(a) Beginning April 1, 2024, each 340B covered entity, as defined by section 340B(a)(4) of the Public Health Service Act, must report to the commissioner of health by April 1 of each year the following information related to its participation in the federal 340B program for the previous calendar year:

(1) the National Provider Identification (NPI) number;

(2) the name of the 340B covered entity;

(3) the servicing address of the 340B covered entity;

(4) the classification of the 340B covered entity;

(5) the aggregated acquisition cost for prescription drugs obtained under the 340B program;

(6) the aggregated payment amount received for drugs obtained under the 340B program and dispensed to patients;

(7) the aggregated payment made to pharmacies under contract to dispense drugs obtained under the 340B program; and

(8) the number of claims for prescription drugs described in clause (6).

(b) The information required under paragraph (a) must be reported by payer type, including commercial insurance, medical assistance and MinnesotaCare, and Medicare, in the form and manner defined by the commissioner. For covered entities that are hospitals, the information required under paragraph (a), clauses (5) to (8), must also be reported at the national drug code level for the 50 most frequently dispensed drugs by the facility under the 340B program.

(c) Data submitted under paragraph (a) must include prescription drugs dispensed by outpatient facilities that are identified as child facilities under the federal 340B program based on their inclusion on the hospital's Medicare cost report.

(d) Data submitted to the commissioner under paragraph (a) must be classified as nonpublic data as defined in section 13.02, subdivision 9.

(e) Beginning November 15, 2024, and by November 15 of each year thereafter, the commissioner shall prepare a report that aggregates the data submitted under paragraph (a). The commissioner shall submit this report to the chairs and ranking minority members of the legislative committees with jurisdiction over health care finance and policy.