CLINICIAN-ADMINISTERED DRUGS (Section 376.411)

This act provides that a health carrier or pharmacy benefits manager (PBM) shall not impose any penalty, impediment, differentiation, or limitation on participating providers for providing medically necessary clinician-administered drugs, regardless of whether the participating provider obtains the drugs from an in-network provider, including but not limited to refusing to approve or pay, or reimbursing less than the contracted payment amount.

Carriers and PBMs shall not impose any penalty, impediment, differentiation, or limitation on a covered person who is administered medically necessary clinician-administered drugs, regardless of whether the participating provider obtains the drugs from an in-network provider, including but not limited to: limiting coverage or benefits; requiring an additional fee, higher co-payment, or higher coinsurance amount; or interfering with a patient's ability to obtain a clinician-administered drug from the patient's provider or pharmacy of choice by any means, including but not limited to inducing, steering, or offering financial or other incentives.

Carriers and PBMs shall not impose any penalty, impediment, differentiation, or limitation on any pharmacy that is dispensing medically necessary clinician-administered drugs, regardless of whether the participating provider obtains the drugs from an in-network provider, including but not limited to requiring a pharmacy to dispense the drugs to a patient with the intention that the patient will transport the medication to a health care provider for administration.

These provisions shall not apply if the clinician-administered drug is not otherwise covered by the carrier or PBM.

These provisions are identical to provisions in SB 751 (2024), provisions in SB 26 (2023), provisions in HCS/HB 198 (2023), SB 1129 (2022), and provisions in HB 2305 (2022), and similar to provisions in SB 921 (2022), provisions in SB 1129 (2022), provisions in HB 2305 (2022), provisions in SB 971 (2020), provisions in HCS/HB 2412 (2020), provisions in the truly agreed to and finally passed SS/SCS/HCS/HB 1682 (2020), provisions in HB 1910 (2020), provisions in SB 413 (2019), and provisions in HB 1165 (2019).

340B DRUG PRICING PROGRAM (Section 376.414)

Under this act, no health carrier or pharmacy benefits manager (PBM) shall discriminate against a covered entity or a pharmacy, as such terms are defined in the act, by:

• Reimbursing a covered entity or specified pharmacy for a quantity of a 340B drug, as defined in the act, in an amount less than the carrier, PBM, or affiliate would pay to any other similarly situated pharmacy for such quantity of the drug on the basis that the entity or pharmacy is a covered entity or a pharmacy, or that the entity or pharmacy dispenses 340B drugs. (Section 376.414.2(1));

• Imposing any terms or conditions on covered entities or specified pharmacies which differ from the terms or conditions applicable to other similarly situated pharmacies or entities on the basis that the entity or pharmacy is a covered entity or dispenses 340B drugs, including but not limited to certain terms and conditions described in the act. (Section 376.414.2(2));

• Interfering with an individual's choice to receive a 340B drug from a covered entity or pharmacy. (Section 376.414.2(3));

• Requiring a covered entity or specified pharmacy to identify 340B drugs, either directly or through a third party, except as required to comply with rebate transparency requirements of a pharmaceutical manufacturer. (Section 376.414.2(4));

• Requiring a covered entity or pharmacy to identify a 340B drug sooner than 45 days after the point of sale of the drug. (Section 376.414.2(5));

• Refusing to contract with a covered entity or pharmacy for reasons other than those that apply equally to entities or pharmacies that are not covered entities or similarly situated pharmacies, or on the basis that the entity or pharmacy is a covered entity as described under federal law, or on the basis that the entity or pharmacy is described as a covered entity under provisions of federal law. (Section 376.414.2(6));

• Denying the covered entity the ability to purchase drugs at 340B program pricing by substituting a rebate discount. (Section 376.414.2(7));

• Refusing to cover drugs purchased under the 340B drug pricing program. (Section 376.414.2(8)); or

• Requiring a covered entity or pharmacy to reverse, resubmit, or clarify a 340B-drug pricing claim after the initial adjudication unless these actions are in the normal course of pharmacy business and not related to the 340B drug pricing, except as required by federal law. (Section 376.414.2(9)).

Entities specified in the act shall not restrict acquisition or delivery of 340B drugs to pharmacies that are under contract with a covered entity to receive 340B drugs on behalf of the covered entity. (Section 376.414.3). Violation of this provision shall be an unlawful merchandising practice, and each package of 340B drugs affected, as defined by federal law, shall constitute a separate violation. (Section 376.414.5). The Board of Pharmacy may investigate and impose discipline for violations of these provisions. (Section 376.414.6).

The Director of the Department of Commerce and Insurance shall impose a civil penalty on any health carrier or PBM violating certain provisions of the act, not to exceed $5,000 per violation per day. (Section 376.414.4).

Nothing in these provisions shall be construed or applied to be less restrictive than federal law, or to conflict with federal or state law. (Section 376.414.8). Limited distribution of a drug required under federal law shall not be a violation of the act. (Section 376.414.9).

Lastly, the act prohibits actions taken with the sole purpose of defrauding the 340B program, and specifies penalties and enforcement mechanisms. (Section 376.414.10).

These provisions are similar to provisions in SB 751 (2024), SB 426 (2023), provisions in HCS/HB 198 (2023), provisions in SB 426 (2023), HB 197 (2023), provisions in SB 921 (2022), provisions in HCS/HB 1677 (2022), provisions in SB 1129 (2022), provisions in HB 2305 (2022), provisions in SB 971 (2020), provisions in HCS/HB 2412 (2020), provisions in the truly agreed to and finally passed SS/SCS/HCS/HB 1682 (2020), provisions in HB 1910 (2020), provisions in SB 413 (2019), and provisions in HB 1165 (2019).

REFERENCE PRODUCTS AND BIOSIMILARS (Section 376.415)

A health carrier or PBM providing coverage for a reference product or a biological product that is biosimilar to the reference product shall provide coverage for the reference product and all biological products that have been deemed biosimilar to the reference product. The scope, extent, and amount of the required coverage shall be the same, including but not limited to any payment limitations or cost-sharing obligations.

These provisions are identical to provisions in SB 751 (2024), provisions in SB 26 (2023), provisions in HCS/HB 198 (2023), SB 1129 (2022), and provisions in HB 2305 (2022), and similar to provisions in SB 921 (2022), provisions in SB 1129 (2022), provisions in HB 2305 (2022), provisions in SB 971 (2020), provisions in HCS/HB 2412 (2020), provisions in the truly agreed to and finally passed SS/SCS/HCS/HB 1682 (2020), provisions in HB 1910 (2020), provisions in SB 413 (2019), and provisions in HB 1165 (2019).

ERIC VANDER WEERD