AN ACT TO AMEND TITLE 18 OF THE DELAWARE CODE RELATING TO PHARMACY BENEFITS MANAGERS.
What changed between versions
The bill expanded from a single narrow amendment to a full act amending six subchapters of Title 18, Chapter 33A (PBMs), covering definitions, audit procedures, appeals, retaliation protections, prior authorization, reporting, and prohibited practices.
Sponsors expanded from Senator Sokola alone to include Representative Burns and additional senators (Sturgeon, Hoffner, Walsh, Hocker, Seigfried) and representatives (Morrison, Romer, Snyder-Hall, Wilson-Anton, Lambert, Griffith).
New audit procedure requirements: 14-day notice before on-site audits, audits involving clinical judgment must be conducted by or in consultation with a licensed pharmacist, pharmacies audited under same standards as similarly situated pharmacies, range of prescription numbers provided at least 5 business days before audit, PBM must provide a contact method for questions, and no more than one audit per pharmacy every 12 months.
Comprehensive appeals process: appeal window extended from 10 to 40 calendar days, PBM must respond within 10 days of an appeal, detailed denial reasons required, notice of right to appeal to the Department of Insurance with specific language, and if an appeal is granted the PBM must adjust reimbursement retroactively without requiring the pharmacy to reverse and rebill.
Prior authorization requirements: PBM may not require prior authorization for 72-hour emergency supplies of noncontrolled substances; prior authorization forms must include a question about chronic or long-term conditions; if indicated as life-necessary, reauthorization may not be requested more frequently than every 12 months; PBMs must provide lists of therapeutically equivalent alternatives.
New prohibited practices: PBMs may not amend contracts without at least 60 days notice; may not require pharmacists to break open unit-of-use items beyond manufacturer recommendations; may not require dispensing of therapeutically equivalent drugs that cost the enrollee more out-of-pocket unless for medical reasons; may not transfer or share prescription information with affiliated pharmacies for commercial purposes other than reimbursement, formulary compliance, or utilization review.
National average drug acquisition cost compliance now refers to the price in effect on the date of service (rather than an unspecified reference point), with wholesale acquisition cost as a fallback when NADAC is unavailable.
Audit costs must be borne solely by the pharmacy benefits manager. PBMs may not impose fees or pass audit-related costs to the audited pharmacy or pharmacist.
Reporting requirements changed from quarterly to annual (by March 31) for PBM revenue sources, rebate distributions, and amounts paid for pharmacy goods and services.
Anti-retaliation provision: PBMs may not retaliate against pharmacists or pharmacies for disclosing information to courts, administrative proceedings, legislative committees, or government agencies when there is reasonable cause to believe the information evidences a violation of law. Retaliatory actions include contract cancellation, restriction, refusal to renew, or refusal to offer a contract.
Commissioner-level appeal process: if a PBM denies an appeal and the pharmacy files with the Commissioner, the Commissioner reviews the PBM's compensation program, can deny or grant the appeal, and pricing information collected is confidential. The non-prevailing party pays Department costs.
Effective date changed from 6 months after enactment to contracts entered into, renewed, amended, or extended after December 31, 2026.
Spread pricing definition changed to apply to all 'purchasers' rather than only 'health benefit plans,' broadening the scope of the prohibition. New definitions added for recoupment, similarly situated contracted pharmacy, wholesale invoice audit, chronic or long-term condition, net amount, and purchaser.