Columbus County Health Department (CCHD) will follow the guidelines set forth by the CDC and DPH guidelines for the practice of purchasing and dispensing 340B drugs for STD clinics, Women’s Health, and TB clinic.
Definitions:
All drugs purchased through the 340B drug pricing program will be obtained, maintained, and dispensed following CDC and DPH guidelines.
Responsibilities:
Health Director, Director of Nursing, Practitioners, and Enhanced Role Nurses certified to dispense drugs.
Procedures:
CCHD 340B Purchase Requirements
To purchase drugs at the 340B price, covered entities must meet the following ongoing requirements:
Keep 340B database information accurate and up to date. Register new outpatient facilities and contract pharmacies as they are added.
Recertify eligibility every year.
Prevent duplicate discounts. Manufacturers are prohibited from providing a discounted 340B price and a Medicaid drug rebate for the same drug. Covered entities must accurately report how they bill Medicaid drugs on the Medicaid Exclusion File, as mandated by 42 USC 256b (a)(5)(A)(i).
Prevent diversion to ineligible individuals. Covered entities must not resell or otherwise transfer 340B drugs to ineligible individuals.
Prepare for program audits. Maintain auditable records documenting compliance with 340B Program requirements. Covered entities are subject to
audit by manufacturers or the federal government. Any covered entity that fails to comply with 340B Program requirements may be liable to manufacturers for refunds of the discounts obtained.
It is the covered entity's responsibility to notify drug manufacturers and wholesalers that it will now purchase outpatient drugs at 340B prices. The wholesalers and manufacturers verify the covered entity’s enrollment on the 340B database and must sell its drugs at or below the maximum price determined under the 340B statute.
Medicaid Exclusion
42 USC 256b (a)(5)(A)(i) prohibits duplicate discounts; that is, manufacturers are not required to provide a discounted 340B price and a Medicaid drug rebate for the same drug. Covered entities must have mechanisms in place to prevent duplicate discounts.
All covered entities that use 340B and bill Medicaid must determine whether they will use 340B drugs for their Medicaid patients (carve-in) or whether they will purchase drugs for their Medicaid patients through other mechanisms (carve-out). Covered entities that will carve-in are required to inform HRSA of their decision by providing their Medicaid provider number/NPI.
If covered entities decide to bill Medicaid for drugs purchased under 340B with a given Medicaid provider number/NPI (carve-in), then ALL drugs billed to Medicaid with that number/NPI must be purchased under 340B and that number/NPI must be listed in the 340B program database. For covered entities that opt to purchase Medicaid drugs outside of the 340B Program (carve-out), ALL drugs billed under the applicable Medicaid provider number/NPI must be purchased outside the 340B Program and that Medicaid provider number/NPI should not be listed on the HRSA Medicaid Exclusion File.
CCHD Clinics Utilizing 340B Drug Pricing Program for
STD/HIV
TB
Family Planning
Maternal Health
An Individual is a Patient of a 340B CCHD Program only if:
CCHD has established a relationship with the individual, such that the covered entity maintains records of the individual’s health care; and
The individual receives health care services from a health care professional who is either employed by CCHD or provides health care under contracted or other arrangements (e.g., referral for consultation) such that responsibility for the care provided remains with CCHD; and
The individual receives a health care service or range of services from CCHD which is consistent with the service or range of services for which grant funding has been provided to the entity.
