Mo. Code Regs. tit. 13 § 70-20.075

Current through Register Vol. 49, No.12, June 17, 2024

Section 13 CSR 70-20.075 - 340B Drug Pricing Program

PURPOSE: This rule establishes the payment methodology for 340B covered entities as defined in section 1927(a)(5)(B) of the Social Security Act that choose to carve-in Medicaid.

(1) 340B-covered entities that choose to carve-in Medicaid must pro- vide the Health Resources and Services Administration (HRSA) with their National Provider Identification (NPI) and their MO HealthNet Division (MHD) provider number for each site that carves in for inclusion in the HRSA Medicaid Exclusion File. The MHD requires the MO HealthNet provider number to be included on the Medicaid Exclusion File to identify providers that carve-in Medicaid and to prevent duplicate discounts.

(2) 340B covered entities are required to identify 340B purchased drugs at the claims level using the following codes:

(A) Point-of-sale pharmacy claims: Submission Clarification Code (SCC) 20; and

(B) Medical and outpatient claims: Modifier JG or TB.

(3) Failure to include the appropriate submission clarification code or modifier on a 340B purchased drug will result in the MHD collecting rebate on the claim and may subject the covered entity to audit penalties. The MHD will deny claims from providers who submit an SCC of 20 or 340B modifier but have not notified HRSA of carve-in status.

(4) Effective July 1, 2021, reimbursement for 340B-identified cov- ered drugs for 340B providers as defined by 42 U.S.C. 256b(a)(4) and 42 U.S.C. 1396r-8(a)(5)(B) who carve-in for Medicaid will be determined by applying the following method:

(A) 340B-purchased drugs dispensed by pharmacy providers will be reimbursed at their actual acquisition cost, up to the 340B Maximum Allowable Cost (MAC) (calculated ceiling price) plus a professional dispensing fee. Covered entities are required to bill no more than their actual acquisition cost plus the professional dispensing fee

1. T1. The 340B MAC (calculated ceiling price) is defined as the Average Manufacturer Price (AMP) minus Unit Rebate Agreement (URA).

2. Actual acquisition cost is defined as the invoice cost for the NDC per billing unit. This does not include timely pay discounts or discounts paid as a rebate on a separate invoice for volume-based purchases; and

(B) Physician-administered drugs purchased through the 340B program will be reimbursed the lesser of the Physician-Administered 340B MAC or the actual acquisition cost submitted by the provider. A professional dispensing fee is not applied to physician-administered drugs.

1. The Physician-Administered 340B MAC is calculated by adding six percent (6%), up to six hundred dollars ($600), to the calculated ceiling price.

(5) 340B contract pharmacies are not covered under this policy and must carve-out Medicaid from their 340B operation unless MHD approves an exception.

13 CSR 70-20.075

Amended by Missouri Register June 1, 2021/Volume 46, Number 11, effective 7/1/2021

Adopted by Missouri Register October 15, 2021/Volume 46, Number 20, effective 11/30/2021