420.001 Certification of TIPP Programs/Providers as Eligible for the 340B Drug Pricing Program

1.0 Purpose

To define Texas Infertility Prevention Project (TIPP) programs and providers that are eligible to participate in the 340B Drug Pricing Program. Participation in the 340B Program provides access to lower cost medications used to treat non-reportable STDs and other genito-urinary infections that may be diagnosed in STD care services. Treating other genito-urinary infections increases opportunities for STD screening and timely treatment and helps the Texas Department of State Health Services STD Program meet its goal of preventing, treating, and controlling the spread of STDs and HIV.
 

2.0 Policy

STD care providers who receive in-kind support from the TIPP are eligible to participate in the 340B Program (See Section 6.1). The TIPP eligibility and participation criteria are described in the policy, “Provider Selection Criteria and Requirements for the Texas Infertility Prevention Project.”
 

3.0 Definitions

Centers for Disease Control and Prevention (CDC) - a component of the Department of Health and Human Services that has funding agreements with state, local, and territorial STD programs for STD prevention and control projects. The Texas Infertility Prevention Project (TIPP) receives 318 funds from the CDC.

Clinical STD services – direct patient sexual health care that includes laboratory testing, physical examination, treatment, referral, and patient education.

Covered entity – An essential community STD care provider that receives in kind support from the TIPP and meets the requirements of the 340B Drug Purchasing Program (See Section 6.2) is eligible to purchase drugs through the 340B Program and appear in the 340B data base. STD care providers who receive in kind support from the TIPP use 340B medications for STD clients only.

Department of State Health Services (DSHS) – The state agency responsible for administering 318 funds from the CDC that support the TIPP.

Essential Community Provider (ECP) - providers that serve predominately low-income medically underserved individuals (AKA safety net providers).

Health Resources and Services Administration (HRSA) – the primary federal agency that oversees the 340B Program administration (enrollment, re-certification, and compliance).

In-Kind Support – For the purposes of this policy, in-kind support is defined as non-cash contributions provided by the TIPP and directly benefiting an STD project or program. In-kind contributions consist of testing supplies and medications which are purchased with 318 funds. Other in-kind support includes laboratory support, technical assistance, quality audits, and training. (Based on the definition found in the Health Resources and Services Administration Dictionary of Grant Terms)

Texas Infertility Prevention Project – A state project funded by the CDC with 318 funds; a partnership between DSHS HIV/STD Prevention and Care Branch, DSHS Community Health Services (Family Planning), and the DSHS Laboratory Sciences Section.

318 Funds - Project funding under Section 318 of the Public Health Service Act awarded by the CDC to state and local health departments for STD prevention and control programs.

340B Drug Pricing Program (340B Program) – A program administered by the Health Resources and Services Administration (HRSA). The program provides access to drugs that are priced lower than typical market prices. The goal of the 340B Program is to provide patients access to affordable medications and to enable eligible STD programs to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.
 

4.0 Persons Affected

• STD Nurse Consultant
• Manager, HIV/STD Prevention and Care Branch
• TIPP Coordinator
• DSHS Pharmacy Branch
• Covered entities
   

5.0 Responsibilities

5.1 DSHS STD Nurse Consultant

In consultation with the manager of the STD Program, the nurse consultant reviews the applications of entities applying for enrollment in the 340B Program. The nurse consultant sends the results of his/her review to the Branch Manager. The nurse consultant also monitors the continuing eligibility of current TIPP participants and verifies each entity’s’ eligibility once a year.
 

5.2 Branch Manager

Approves the applicant for participation in the 340B Program.
 

5.3 Covered entity

Ensures all information in the 340B data base is current and maintains up-to-date policies and procedures that comply with all aspects of the 340B Drug Pricing Program. (See Section 6.2)
 

5.4 TIPP Coordinator

At the beginning of each calendar year, submits a list of all entities in good standing and receiving in-kind support from the TIPP to the STD Program Nurse Consultant.
 

5.5 DSHS Pharmacy Branch

Purchases antibiotics under the 340B Drug Pricing Program and distributes antibiotics, vaccines, and certain medical supplies for the prevention, diagnosis, and treatment of STDs.
 

6.0 Requirements

6.1 Criteria that will be used to verify the provider’s eligibility to enroll in the 340B Program

The entity receives in-kind support from the TIPP. (See Provider Selection Criteria and Requirements of the Texas Infertility Prevention Project Policy 420.002)
 

6.2 Requirements of the 340B Program

Eligible patient – A patient is eligible to receive drugs purchased under the 340B program when an approved provider:

• Establishes a health care relationship with the patient;
• Maintains records of the patient’s health care;
• Provides direct STD care (or employs or contracts with another licensed health care professional) and assumes responsibility for patient care; and
• Maintains auditable records and permit audits by drug manufacturers and/or HRSA.
   

6.3 Verification

On a quarterly basis, when there are new 340B Program applicants, the STD Nurse Consultant, in consultation with the STD Program Manager, will verify that the applicants are eligible to participate in the 340B Drug Purchasing Program based on the criteria outlined in Sections 5.4 and 6.1 and send the results of his/her review to the Branch Manager.
 

6.4 Approval

The Branch Manager approves the entity for participation in the 340B Program.
 

6.5 Responsibilities

Once a covered entity is designated as eligible for 340B as an STD provider, the entity is solely responsible for annual re-certification and attestation that the program has supplied accurate information to the 340B Program. Entities are solely responsible for ensuring that only eligible patients receive 340B drugs, that a Medicaid rebate is not paid on a 340B purchased drug, and all entity eligibility requirements are met. (See Section 6.2)
 

6.6 Withdrawal of 340B Designation

DSHS may withdraw designation of a provider or program as an eligible STD provider if the provider or program violates the rules of the TIPP or no longer receives in-kind support from the TIPP. Designation of a provider or program or withdrawal of this designation is at the sole discretion of the HIV/STD Prevention and Care Branch (See Provider Selection Criteria and Requirements of the Texas Infertility Prevention Project Policy 420.002, Section 3.6).
 

7.0 Revision History