Mo. Code Regs. tit. 13 § 70-20.075

Current through Register Vol. 50, No. 1, January 2, 2025

Section 13 CSR 70-20.075 - [Effective until 6/6/2025] 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) Covered entities that choose to carve-in Medicaid must provide 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. MHD requires the MHD provider number to be included on the Medicaid Exclusion File to identify providers that carve-in Medicaid and to prevent duplicate discounts. A duplicate discount is defined as a covered entity receiving a discounted drug through the 340B program from the manufacturer, and MHD receives a rebate through the Medicaid Drug Rebate Program from the manufacturer for the same claim. Covered entity is defined in section 376.414.1(2), RSMo.

(2) Covered entities must identify 340B-purchased drugs using the Submission Clarification Code or modifier code on each claim that was 340B-purchased.

(3) Failure to include the appropriate identifier on a 340B-purchased drug will result in the MHD collecting a rebate on the claim, resulting in a potential duplicate discount. A duplicate discount may subject the covered entity to audit penalties. MHD will deny claims identified as 340B purchased drugs at the claim level from providers who have yet to notify HRSA of carve-in status.

(4) Reimbursement for 340B-identified covered drugs for 340B providers as defined in Section 376.414.1(2), RSMo who carve-in for Medicaid will be determined by applying the following method:

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

1. MHD defines the 340B MAC (calculated ceiling price) as the Average Manufacturer Price (AMP) minus Unit Rebate Agreement (URA) as reported by the Centers for Medicare & Medicaid (CMS) quarterly;

2. MHD defines actual acquisition cost as the invoice cost for the National Drug Code (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

3. MHD calculates the professional dispensing fee according to 13 CSR 70-20.060; and

(B) MHD will reimburse physician-administered drugs purchased through the 340B program at the lesser of the physician-administered 340B MAC or the actual acquisition cost submitted by the provider. MHD does not apply a professional dispensing fee to physician-administered drugs.

1. MHD adds six percent (6%), up to six hundred dollars ($600), to the 340B MAC to calculate the physician-administered 340B MAC.

(5) MHD does not allow 340B contract pharmacies to carve-in under this policy.

(6) MHD may carve-out certain medications and categories of medications from 340B participation for MHD reimbursement. Medications subject to the carve-out will be reimbursed according to 13 CSR 70-20.070. The following medications and categories of medications are carved-out of reimbursement through the 340B program:

(A) Drugs approved by the FDA for the treatment of obesity; and

(B) Cell and Gene Therapies.

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

Amended by Missouri Register January 2, 2025/volume 50, Number 01, effective 12/9/2024, exp. 6/6/2025 (Emergency).