Colorado Code § 10-16-122.4

Pharmacy benefits - formulary change prohibition - exceptions - enforcement - definition - rules
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(1) (a) Starting in 2024, except as provided in subsection (2)
of this section, a carrier or, if a carrier uses a PBM for claims processing services or other
prescription drug or device services, as those terms are defined in section 10-16-122.1, under a
health benefit plan offered by the carrier in the individual market, the PBM, or a representative
of the carrier or the PBM, shall not modify or apply a modification to the current prescription
drug formulary during the current plan year.
(b) As used in this subsection (1), "modify" or "modification" includes eliminating a
particular prescription drug from the formulary or moving a prescription drug to a higher cost-
sharing tier.
(2) A carrier offering a health benefit plan on the individual market in this state that
includes a prescription drug benefit and uses a prescription drug formulary or list of covered
drugs may:
(a) Remove a prescription drug from the prescription drug formulary or list of covered
drugs, with notice to a covered person and the covered person's provider, if:
(I) The FDA issues an announcement, guidance, notice, warning, or statement
concerning the prescription drug that calls into question the clinical safety of the prescription
drug; or
(II) The prescription drug is approved by the FDA for use without a prescription;
(b) Move a prescription drug from a prescription drug cost-sharing tier that imposes a
lesser copayment or deductible for the prescription drug to a cost-sharing tier that imposes a
greater copayment or deductible for the prescription drug if the carrier adds to the prescription
drug formulary or list of covered drugs a generic prescription drug or biosimilar drug that is:
(I) Approved by the FDA for use as a therapeutic equivalent; and
(II) In a prescription drug cost-sharing tier that imposes a copayment or deductible for
the generic prescription drug or biosimilar drug that is less than the copayment or deductible that
is imposed for the brand-name prescription drug in the cost-sharing tier to which the brand-name
prescription drug is moved; or
(c) Remove a prescription drug from the prescription drug formulary or list of covered
drugs, or move a prescription drug to a higher cost-sharing tier, with advance notice to a covered
person and the covered person's provider, if:
(I) The prescription drug has a wholesale acquisition cost greater than five hundred
dollars at the start of the benefit year and the carrier's net cost increases by fifteen percent or
more during that benefit year; and
(II) The prescription drug will be replaced on the formulary with a therapeutically
equivalent generic or multi-source brand-name drug, an interchangeable biologic, or biosimilar
drug at a lower cost to the enrollee.
(3) Prior to removing a drug from a formulary pursuant to this section, the carrier must
attest and demonstrate to the division, in a form and manner determined by the commissioner by
rule, that it has complied with the requirements of this section and has provided advanced notice
to its enrollees.
(4) This section does not prohibit a carrier from adding a prescription drug to a
prescription drug formulary or list of covered drugs at any time.
(5) The commissioner may promulgate rules to implement and enforce this section.
(6) With regard to the requirements of this section applicable to PBMs, the
commissioner has the authority to enforce this section and to impose a penalty or other remedy
against a PBM that fails to comply with this section.

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