SECURE 340B Act

Clearer Patient Definition: Establishing specific criteria for who qualifies as a "patient" clarifies the relationship between covered entities and those receiving care (Section 2).

Increased Affordability via Financial Assistance: Covered entities must maintain and extend financial assistance policies to patients at their child sites and contract pharmacies (Section 5).

Sliding Fee Scales: Certain covered entities are required to use sliding fee scales for covered outpatient drugs to assist patients (Section 5).

Medical Debt Protections: The bill prohibits certain covered entities from selling patient debt to third parties, reporting adverse information to credit bureaus, or denying medically necessary care due to non-payment (Section 5).

Expanded Access through Referrals: Certain entities, such as critical access hospitals, can provide discounted drugs to patients referred by the covered entity (Section 2).

Transparency in Pharmacy Arrangements: The Secretary is required to make information regarding contract pharmacy arrangements available on a public website (Section 3).

Increased Transparency of Pharmacy Fees: The Secretary will study dispensing fees and reimbursements paid to pharmacies to determine if they are reasonable (Section (a)(1)).

Improved Oversight of the 340B Discount: The Comptroller General will study how the 340B discount is retained by various entities, including contract pharmacies, health plans, and patients (Section (b)(1)).

Scrutiny of Hospital Debt Collection: The Comptroller General will report on the debt collection practices of hospitals, including those in the 340B program (Section (c)).

Enhanced Monitoring of Care for Low-Income Populations: The Comptroller0 General will analyze contracts between local governments and certain non-profit hospitals to assess care provided to individuals at or below 400 percent of the Federal Poverty Level (Section (d)(1)(B)).

Protection of Underserved Populations: The bill requires an analysis of how violations impact the ability of Federally Qualified Health Centers to provide affordable care to underserved populations (Section (d)(1)(E)).

Increased Administrative Burden for Entities: Covered entities must maintain extensive auditable health care records and undergo regular audits (Section 2).

Strict Eligibility Requirements for Child Sites: To participate, child sites must meet rigorous integration, ownership, and community need standards (Section 4).

New Costs for Covered Entities: A user fee program is established where entities pay a fee based on their previous year's drug purchases (Section 10).

Potential Loss of Discount Eligibility: Entities may lose eligibility for the drug discount program if they fail to comply with required corrective action plans (Section 2).

Mandatory Data Transmission: Entities are required to participate in a new data transmission process through a third-party clearinghouse (Section 8).

Increased Administrative Burden for Non-Hospital Entities: Non-hospital covered entities and subgrantees face strict new requirements, including enforceable written agreements, specific record-keeping, and registration in a central system (Section 13(i)).

Strict Participation Limitations: Participation for certain entities is tied to specific conditions, such as being a nonprofit or public entity and ensuring services are within the scope of Federal grants (Section 13(i)(I)).

Potential Loss of Program Access: Subgrantees may need to disenroll from the program if they no longer meet specific requirements, such as demographic thresholds related to State Medicaid enrollment (Section 13(ii)(III) and (V)).