2023.011 Penicillin G Benzathine (Bicillin) Treatment

1.0 Purpose

The Texas Department of State Health Services (DSHS) purchases penicillin G benzathine through the federal 340B drug discount program. Entities participating in the DSHS Central Distribution Model (CDM) prevent violations of the 340B drug discount program, including diversion and duplicate discounts, and follow DSHS policies and procedures under the CDM. Public health entities work to treat occurrences of syphilis and prevent congenital syphilis across Texas. Patients must meet the patient eligibility criteria in Policy 2023.004, 340B Patient Eligibility.
 

2.0 Definitions

340B Covered Entity (CE) – A program or facility participating in the 340B medication program. This includes DSHS as a direct recipient of federal funds as well as DSHS’s covered entities receiving federal funds or in-kind services from DSHS and utilizing a DSHS grant number for registering their program in the 340B Office of Pharmacy Affairs Information System (OPAIS) database. 

340B Program – Refers to the federal Health Resources and Service Administration’s (HRSA) 340B drug pricing program, which reduces the cost of covered outpatient drugs for certain federally supported entities and eligible healthcare organizations. The use of the term “340B” throughout this policy refers to the 340B program. 

Central Distribution Model (CDM) – When a CE purchases medications under one account to send to multiple eligible locations, each of the locations has its own 340B ID, except for DSHS Regional Clinics and pharmacies participating in the Texas HIV Medication Program (THMP).

Contract Pharmacy – 340B-covered entities may contract with a pharmacy (or pharmacies) to provide services to the CE’s patients, including the service of dispensing the entity-owned 340B drugs. To engage in a contract pharmacy arrangement, the CE and pharmacy (or pharmacies) must have a written contract or a memorandum of understanding (MOU) aligning with 340B compliance elements. Typically, a CE or facility uses a bill-to (entity) or ship-to (pharmacy) arrangement. Covered entities must identify the contract pharmacy on their 340B OPAIS account and can only add or remove the contract pharmacy during a quarterly registration period. 

Direct Funding – Funding provided to an organization directly from the federal government. This policy does not consider funding received from DSHS as direct funding. 

Local Public Health Entity – A local health authority, local health unit, local health department, or public health district. For this policy, each local public health entity must meet the eligibility criteria listed in 8.0 of Policy 2023.005, Covered Entity Eligibility and Central Distribution Model Participation. 

Memorandum of Understanding (MOU) – Contracts that involve the exchange of promises, with or without the actual exchange of money. In general, MOUs are legally enforceable.

Office of Pharmacy Affairs (OPA) – The office within the Health Resources and Service Administration (HRSA) responsible for administering the 340B drug pricing program.

Office of Pharmacy Affairs Information System (OPAIS) – The system used to verify entity eligibility. The use of the term “OPAIS database” in this policy refers to this system. 

Program – The specific program that awarded a contract or provided in-kind services to an entity such as Tuberculosis (TB), Sexually Transmitted Diseases (STD), or Human Immunodeficiency Virus (HIV).

Registry – A list of entities that the local health entity or regional clinic has on file for anyone actively pursuing an MOU with to be responsible for administering medication(s) to an eligible patient during a national drug shortage. The local health entity or regional clinic can keep this list electronically or in paper documentation form, accompanied by a DSHS Attestation Form completed for each listed entity.

Uninsured Patient – A patient who experiences circumstances which might influence or restrict access to necessary preventive health care services or medication. These circumstances might include, but are not limited to, patients who are concerned about privacy when using their insurance or have a financial burden due to high deductibles or co-pays, a patient whose provider would not be able to provide timely treatment, or a partner of a contact identified through partner services by a Disease Intervention Specialist (DIS).
 

3.0 Persons Affected

• Programs participating in 340B, including recipients of 340B medication.
   

4.0 Responsibilities

4.1 Division Heads (Laboratory and Infectious Disease Services and Regional and Local Health Operations Division Heads)

• Ensure agency policies and division operation procedures are in alignment with: 
  • Federal and state statutes, rules, and guidelines;
  • DSHS and HHS policies; and 
  • Guidelines defined by external funding sources.
     

4.2 DSHS and CE Supervisors

• Ensure the implementation of this policy.
• Ensure they communicate policies and procedures to employees.
• Document instances of violations of this policy and report them to the section director and 340B coordinator.
   

4.3 DSHS and CE Employees

• Understand and comply with this policy.
• Ask the supervisor to clarify responsibilities for complying with policies and procedures as necessary.
• Report perceived conflicts or discrepancies between different DSHS policies and procedures to the supervisor.
• Report instances of violations of this policy to the supervisor
   

5.0 CE and Provider Procedures

5.1 The provider sends the patient to the local health department, when available.

**This should be the primary goal for treatment.**

If a patient cannot travel to the local health entity or regional clinic, please see 5.2.

5.2 Procedure for documenting patient eligibility for clinics requesting penicillin G benzathine (Bicillin) from local public health entities and obtaining an MOU with the provider and a DSHS Attestation Form

1. Determine patient status.

   • Each patient must meet the DSHS uninsured definition for STD program patients. The public health entity maintains documentation of the patient’s uninsured status.

2. Maintain records of an individual’s health care.

   • The public health entity establishes or shares a patient chart.

   • Determine whether the individual receives a health care service or range of services from the CE consistent with the service or range of services for which the program provided grant funding to the CE.

3. Determine TB/STD/HIV/Ryan White provider eligibility.

   • Patient’s provider and public health entity both document communication and agreement to the treatment plan in the patient’s chart.

   • The clinic follows standing delegation orders.

4. The patient’s provider sends documentation of the administration of penicillin G benzathine to the public health entity. The public health entity documents confirmation that the patient received treatment, including the date(s) of administration.
    
5. Keep an MOU on file.
    
6. During a national drug shortage, a registry with a compliance attestation form shall be used for the Local Health Departments that are actively pursuing an MOU with a provider to continue to treat patients.
    
7. Determine the patient’s Medicaid status. Refer to Policy 2023.007, Prevention of Duplicate Discounts.
    

6.0 Revision History

7.0 Associated Policies