Healthcare (Prescription Drugs)

This Act modernizes Delaware’s pharmacy practice laws by authorizing pharmacists to practice to the full extent of their education and training. Pharmacists have the expertise necessary to provide patient care beyond what current Delaware law allows, and enabling them to do so is an important step toward expanding access to health care in this State. Under this Act, pharmacists are permitted to independently evaluate patients, identify health conditions, order and prescribe laboratory tests, and prescribe drugs or devices without reliance on statewide protocols, formularies, or specified lists of conditions. Pharmacists may not prescribe controlled substances, with the exception of medications for the treatment of opioid use disorder, which pharmacists may only prescribe under a standing order from the Division of Public Health. In order to enable pharmacists to prescribe medications for the treatment of opioid use disorder under a standing order, this Act also amends the Uniform Controlled Susbstances Act in Chapter 47 of Title 16 to include “pharmacist” in the definition of “practitioner.” To ensure continuity of care, this Act also establishes requirements for documentation of treatment and communication with primary care providers. This Act takes effect immediately, but implementation is delayed by up to 1 year to give the Board of Pharmacy time to implement necessary regulations. This Act does not affect current law regarding the use of statewide protocols, standing orders, or collaborative practice agreements. This Act also makes technical corrections to conform existing law to the standards of the Delaware Legislative Drafting Manual.

This Act modernizes Delaware law by adding modern medical treatment options biologics or biosimilars to the step therapy exception process. The current law was passed before biosimilars were widely available. Biosimilars are to biologics what generic drugs are to traditional drugs once their exclusivity expires. This revision adds an exclusion to step therapy protocol exceptions for interchangeable biologics and biosimilars.

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.

This Act allows drug manufacturers or their agents and wholesalers to ship dialysate drugs and devices directly to home dialysis patients without a pharmacy license.

This is a Substitute for Senate Joint Resolution No. 7. Like Senate Joint Resolution No. 7, this Substitute directs the State Employees Benefits Committee (SEBC) to utilize specific strategies and policies when interacting and contracting with Pharmacy Benefit Managers (PBM) in order to achieve lower cost pharmaceutical drug benefit plans for the State. This Substitute differs from Senate Joint Resolution No. 7 by clarifying that the SEBC has a duty to consider all of the following strategies and policies when negotiating for pharmaceuticals: 1. Drug cost transparency. 2. Formation of an independent Pharmacy and Therapeutics Committee. 3. Any other supply chain tactics such as a reverse auction or transparency committee. 4. Compacts with other states to negotiate directly with drug manufacturers. 5. Paying no higher price for all drugs negotiated by Medicare. 6. Requiring PBMs disclose administrative expenses for all pharmaceutical drugs. 7. Requiring PBMs bid based on lowest pricing sources, not average wholesale price. 8. Requiring the SEBC be provided all agreements between PBMs and pharmaceutical companies when those agreements are for drugs contracted for on behalf of the SEBC. 9. Performing audits when the SEBC believes it should be entitled to information to achieve transparency or clarity. This Substitute differs from Senate Joint Resolution No. 7 by directing the SEBC to prepare a report by August 1, 2026, to summarize any difficulties in implementing any of these policies and to submit the report to the Governor; the President Pro Tempore of the Senate and Speaker of the House of Representatives, for distribution to all members of the General Assembly; the Director and the Librarian of the Division of Legislative Services; and the Public Archives.