HF 544

1st Engrossment - 93rd Legislature (2023 - 2024) Posted on 03/08/2023 11:09am

A bill for an act
relating to health; establishing requirements for pharmacy benefit managers and
health carriers related to clinician-administered drugs; proposing coding for new
law in Minnesota Statutes, chapter 62W.

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

Section 1.

[62W.15] CLINICIAN-ADMINISTERED DRUGS.

Subdivision 1.

Definitions.

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

(b) "Affiliated pharmacy" means a pharmacy in which a pharmacy benefit manager or
health carrier has an ownership interest either directly or indirectly, or through an affiliate
or subsidiary.

(c) "Clinician-administered drug" means an outpatient prescription drug other than a
vaccine that:

(1) cannot reasonably be self-administered by the patient to whom the drug is prescribed
or by an individual assisting the patient with self-administration; and

(2) is typically administered:

(i) by a health care provider authorized to administer the drug, including when acting
under a physician's delegation and supervision; and

(ii) in a physician's office, hospital outpatient infusion center, or other clinical setting.

Subd. 2.

Prohibition on requiring coverage as a pharmacy benefit.

A pharmacy
benefit manager or health carrier shall not require that a clinician-administered drug or the
administration of a clinician-administered drug be covered as a pharmacy benefit.

Subd. 3.

Enrollee choice.

A pharmacy benefit manager or health carrier:

(1) shall permit an enrollee to obtain a clinician-administered drug from a health care
provider authorized to administer the drug, or a pharmacy;

(2) shall not interfere with the enrollee's right to obtain a clinician-administered drug
from their provider or pharmacy of choice, and shall not offer financial or other incentives
to influence the enrollee's choice of a provider or pharmacy;

(3) shall not require clinician-administered drugs to be dispensed by a pharmacy selected
by the pharmacy benefit manager or health carrier; and

(4) shall not limit or exclude coverage for a clinician-administered drug when it is not
dispensed by a pharmacy selected by the pharmacy benefit manager or health carrier, if the
drug would otherwise be covered.

Subd. 4.

Cost-sharing and reimbursement.

A pharmacy benefit manager or health
carrier:

(1) may impose coverage or benefit limitations on an enrollee who obtains a
clinician-administered drug from a health care provider authorized to administer the drug,
or a pharmacy, only if these limitations would also be imposed were the drug to be obtained
from an affiliated pharmacy or a pharmacy selected by the pharmacy benefit manager or
health carrier;

(2) may impose cost-sharing requirements on an enrollee who obtains a
clinician-administered drug from a health care provider authorized to administer the drug,
or a pharmacy, only if these requirements would also be imposed were the drug to be obtained
from an affiliated pharmacy or a pharmacy selected by the pharmacy benefit manager or
health carrier; and

(3) shall not reimburse a health care provider or pharmacy for clinician-administered
drugs and their administration, at an amount that is lower than would be applied to an
affiliated pharmacy or pharmacy selected by the pharmacy benefit manager or health carrier.

Subd. 5.

Other requirements.

A pharmacy benefit manager or health carrier:

(1) shall not require or encourage the dispensing of a clinician-administered drug to an
enrollee in a manner that is inconsistent with the supply chain security controls and chain
of distribution set by the federal Drug Supply Chain Security Act, United States Code, title
21, section 360eee, et seq.;

(2) shall not require a specialty pharmacy to dispense a clinician-administered medication
directly to a patient with the intention that the patient will transport the medication to a
health care provider for administration; and

(3) may offer, but shall not require:

(i) the use of a home infusion pharmacy to dispense or administer clinician-administered
drugs to enrollees; and

(ii) the use of an infusion site external to the enrollee's provider office or clinic.

EFFECTIVE DATE.

This section is effective January 1, 2024.