Company: INTS
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001567264-25-000010
Chunk: 178

Company: INTENSITY THERAPEUTICS, INC.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 178
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 MDRP and the rebate amount for the covered outpatient drug as calculated under the MDRP. In general, products subject to Medicaid price reporting and rebate liability are also subject to the 340B Program ceiling price requirement. We must report 340B Program ceiling prices to HRSA on a quarterly basis, and HRSA publishes them to 340B Program covered entities and state Medicaid programs. HRSA regulations set forth requirements to the calculation of the 340B Program ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge covered entities for 340B Program eligible drugs. In April 2024, HRSA finalized an administrative dispute resolution process through which 340B Program covered entities may pursue claims against participating manufacturers for overcharges. A recent court decision in the District Court of South Carolina, Genesis Health Care, Inc. v. Becerra, found that HRSA’s definition of “patient” as applied to the 340B Program was too broad and may result in covered entities expanding the number of individuals considered eligible to receive drugs purchased through the 340B Program, resulting in higher volumes of drugs purchased at the discounted 340B Program ceiling price. In addition, legislation may be introduced that, if passed, would further expand the 340B Program, such as adding further covered entities or requiring participating manufacturers to agree to provide 340B Program discounted pricing on drugs when used in an inpatient setting. 

In order for products, if approved, to be eligible for coverage under the Medicaid and Medicare Part B programs and to be purchased by certain federal agencies and grantees, we must also participate in the Department of Veterans Affairs Federal Supply Schedule (“FSS”) pricing program. A participant in the FSS pricing program must list its covered (innovator and authorized generic) drugs on an FSS contract and charge no more than Federal Ceiling Price (“FCP”), to the Department of Veterans Affairs, Department of Defense, Public Health Service, and Coast Guard when those agencies purchase from the FSS contract or a depot contract. FCP is calculated based on non-federal average manufacturer price data, which participating manufacturers are required to submit quarterly and annually. In addition, because our products, if approved, will likely be available in the retail and specialty pharmacy setting, we will be required to provide rebates to the Department of Defense for prescriptions dispensed to Tricare beneficiaries from Tricare retail network pharmacies under the Tricare Retail Refund Program. If a manufacturer participating in the FSS program fails to provide timely information or