Prescription drug cost sharing.

Three new exceptions where drug manufacturer direct support will NOT be counted toward cost sharing: (A) a covered generic equivalent exists at a lower cost sharing tier, (B) a covered interchangeable biosimilar or biosimilar drug exists at the same or lower cost sharing, or (C) the drug's active ingredients are available in FDA-regulated over-the-counter products at a lower cost and are not contraindicated for the approved condition.

A carve-out to the exceptions: they do not apply if the enrollee or insured has obtained coverage for a medically necessary nonformulary or nonpreferred prescription drug under state or federal law, meaning manufacturer assistance still counts in those cases.

New notification requirement: amounts paid by drug manufacturers on behalf of an enrollee or insured will only be counted toward cost sharing if the pharmacy processing the claim notifies the applicable health care service plan or health insurer of the use of assistance, the person to whom it was provided, and the amount of assistance.

Two new definitions added: 'Biosimilar' (defined by reference to Section 262(i)(2) of Title 42 U.S.C.) and 'Interchangeable biological product' (defined by reference to Section 262(i)(3) of Title 42 U.S.C.).

Changed 'for a drug' to 'for a covered drug' in the main counting provision for both health care service plans and health insurers, narrowing the requirement to drugs that are covered under the plan or policy.

Removed the word 'civil' before 'an administrative penalty not to exceed ten thousand dollars' in the Insurance Code enforcement section, correcting a drafting error from the Senate version.

A new exception was added to both the Health and Safety Code (Section 1399.852(a)(3)) and Insurance Code (Section 10112.283(a)(3)) sections. Amounts paid on behalf of an enrollee or insured by a drug manufacturer that are permitted under subdivision (b) of Section 132000 are now excluded from the requirement to count toward out-of-pocket maximums and deductibles. This narrows the bill's reach by exempting a specific category of manufacturer direct support.

A new subsection was added to both sections (Section 1399.852(e) and Section 10112.283(f)) addressing HSA-qualified high deductible health plans. If applying the bill would cause a plan to lose HSA eligibility under federal law (Section 223 of Title 26), the cost-sharing counting requirement only applies after the enrollee or insured has met the minimum deductible required for HSA qualification. An exception preserves full application for preventive care items and services under Section 223(c)(2)(C).

In the Insurance Code penalty provision (Section 10112.283(d)), the willful violation penalty was relabeled from 'a civil penalty not to exceed ten thousand dollars' to 'an administrative penalty not to exceed ten thousand dollars,' correcting the characterization of the penalty type assessed by the Insurance Commissioner.