Colo. Rev. Stat. § 10-16-122.4
Pharmacy benefits - formulary change prohibition - exceptions - enforcement - definition - rules.
Effective Aug 7, 2023L. 2022: Entire section added, (HB 22-1370), ch. 184, p. 1229, § 2, effective August 10. L. 2023: (6) added, (HB 23-1227), ch. 160, p. 695, § 3, effective August 7.
(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.
Source: L. 2022: Entire section added, (HB 22-1370), ch. 184, p. 1229, § 2, effective August 10. L. 2023: (6) added, (HB 23-1227), ch. 160, p. 695, § 3, effective August 7.
Editor's note: Subsection (3) was numbered as subsection (2)(d) in House Bill 22-1370 but was renumbered on revision, resulting in the renumbering of subsections (3) and (4) in House Bill 22-1370 to subsections (4) and (5), respectively.