This Act strengthens procedural protections for pharmacies, pharmacists, and consumers related to regulation of a pharmacy benefits manager by doing all of the following:
Adds definitions for the terms “chronic or long-term condition”, “net amount”, “purchaser”, “recoupment”, “similarly situated contracted pharmacy”, and “wholesale invoice audit.”
Applies audit notice requirements uniformly and ensures access to an appropriate point of contact. Requires a pharmacy benefits manager to provide a list of records that the auditing entity seeks to audit at least 5 business days before an audit. Limits activities to once every 12 months and sets standards for wholesale invoice audits. Ensures audit costs are borne solely by the pharmacy benefits manager.
Clarifies that a pharmacy can appeal the amount of any reimbursement and that a contracted pharmacy’s representative can take actions and receive notices related to appeals on behalf of a pharmacy. Extends pharmacies’ ability to appeal from 10 days to 40 days to account for entities that complete retroactive billing. When an appeal is denied, requires the parties to provide a detailed reason for the denial and specific information about how the pharmacy can appeal the denial to the Department of Insurance.
Prohibits retaliation by a pharmacy benefits manager when a pharmacist or pharmacy discloses information to a government agency or during a proceeding if the person who disclosed the information had reasonable cause to believe that the disclosed information is evidence of a violation of a state or federal law.
Requires that a pharmacy benefits manager must provide at least 60 days’ notice before amending a contract with a pharmacy or pharmacist.
Clarifies that the prohibition against spread pricing applies to all purchasers contracting with pharmacy benefits managers.
Changes the reporting requirements for rebates so that pharmacy benefits managers must file the required reports annually instead of quarterly. This change will reduce the amount of incorrect or unclear reporting because rebates are aggregated and reported at the end of the period of time under each contract.
Amends national drug acquisition cost compliance to refer to the date of service. Prohibits pharmacy benefit managers from unit-of-use requirements inconsistent with smallest package size availability and manufacturer recommendations. Requires that pharmacy benefit managers may not require pharmacies to dispense therapeutically equivalent or alternative drugs that cost the enrollee more out of pocket than the prescribed drug except for medical reasons. Ensures that enrollee-identifiable or prescriber-identifiable information is not transferred to or shared with affiliated pharmacies for any commercial purpose other than those defined.
This Act also makes technical corrections to conform existing law to the standards of the Delaware Legislative Drafting Manual.