Current through Register Vol. 42, No. 11, August 30, 2024
(1) The
Veterans Health Care Act of 1992 enacted section 340 B of the Public Health
Services Act, "Limitation on Prices of Drugs Purchased by Covered Entities".
This Section provides that a manufacturer who sells covered outpatient drugs to
eligible 340B entities must sign a pharmaceutical pricing agreement with the
Secretary of Health and Human Services in which the manufacturer agrees to
charge to Medicaid a price for covered outpatient drugs that will not exceed
the average manufacturer price decreased by a rebate percentage.
(a) Eligible 340B entities are defined in
42 U.S.C. §
256b(a) (4).
(b) When an eligible 340B entity, other than
a disproportionate share hospital, a children's hospital excluded from the
Medicare prospective payment system, a free-standing cancer hospital exempt
from the Medicare prospective payment system, sole community hospital, rural
referral center, or critical access hospital, submits a bill to the Medicaid
Agency for a drug purchased by or on behalf of a Medicaid recipient, the amount
billed shall not exceed the entity's actual acquisition cost for the drug, as
charged by the manufacturer at a price consistent with the Veterans Health Care
Act of 1992, plus the dispensing fee established by the Medicaid Agency. A
disproportionate share hospital, children's hospital excluded from the Medicare
prospective payment system, free-standing cancer hospital exempt from the
Medicare prospective payment system, sole community hospital, rural referral
center, or critical access hospital may bill Medicaid the total charges for the
drug. As manufacturer price changes occur, the entities must ensure that their
billings are updated accordingly.
(c) Eligible 340B entities are identified on
the Department of Health and Human Service's website. These entities shall
notify Medicaid of their designation as a 340B provider.
(d) Audits of the eligible 340B entities'
(claims submissions and invoices) will be conducted by the Medicaid Agency.
Eligible 340B entities, other than the providers listed above in paragraph (b),
must be able to verify acquisition costs through review of actual invoices for
the time frame specified. Charges to Medicaid in excess of the actual invoice
costs will be subject to recoupment by the Medicaid Agency in accordance with
Chapter 33 of the Administrative Code.
