340B Patient Definition

FAQ ID: 1538

Last Modified: 08/23/2023

Q: What are elements to consider in development of a tracking system for the use of 340B drugs in a mixed-use setting?

A: Based on the practice of 340B covered entities, the following are suggested elements to consider in development of a tracking system for use of 340B drugs in a mixed-use setting:
1. Outpatient status - hospital billing reports or admission/discharge/transfer reports with date/time stamp
2...
Continue Reading

FAQ ID: 1375

Last Modified: 08/02/2022

Q: May 340B drugs be used for individuals who are partners of patients being treated for an STD at a 340B covered entity?

A: STD partner therapy may be 340B eligible to the extent that they are patients of the covered entity. More information on HRSA’s patient definition guidance can be found at ...
Continue Reading

FAQ ID: 1442

Last Modified: 08/02/2022

Q: May providers that have admitting privileges at our 340B participating hospital be considered eligible providers under the "other arrangements" provision of patient definition?

A: Covered entities should consider all aspects of patient definition in order to use 340B drugs. ...
Continue Reading

FAQ ID: 1487

Last Modified: 08/02/2022

Q: Under what circumstances may our 340B hospital use 340B drugs for patients served by our Accountable Care Organization (ACO) partners?

A: The inclusion of a covered entity in an ACO does not automatically make individuals receiving services from the ACO patients of the covered entity for 340B Program purposes. All individuals receiving 340B drugs must be eligible patients of the covered entity and should adhere to 340B patient definit...
Continue Reading

FAQ ID: 1593

Last Modified: 08/02/2022

Q: What details are expected in a contract between a private physician and a hospital to ensure that the patients, seen by the physician “under contract with the hospital,” are 340B eligible? Must payments be involved?

A: HRSA recommends that such contracts would be written to include the provision of services where the entity maintains records of the individual’s health care and the responsibility for care provided remains with the covered entity. For more information, please review the 340B Patient Definition final...
Continue Reading

FAQ ID: 1642

Last Modified: 08/02/2022

Q: What is the HRSA definition of a patient for 340B purposes?

A: An individual is a patient of a 340B covered entity (with the exception of State-operated or funded AIDS drug purchasing assistance programs) only if:

•the covered entity has established a relationship with the individual, such that the covered entity maintains records of the individual's...
Continue Reading

FAQ ID: 1307

Last Modified: 09/30/2020

Q: Does STD testing satisfy the 340B Program’s health care services requirement?

A: STD testing may satisfy the 340B Program’s health care services component. HRSA advises covered entities to document meeting all aspects of the 340B patient definition for such health care services in order to use 340B drugs.

FAQ ID: 1372

Last Modified: 09/30/2020

Q: Must hospitals be able to tie the use of anesthesia gases to a patient if they are purchased under the 340B Drug Pricing Program?

A: Yes. The hospital is prohibited from diverting 340B drugs to ineligible patients and should be able to document meeting all aspects of the 340B patient definition in order to use 340B drugs. In the case of anesthesia gases purchased through the 340B Program, if hospitals use them in mixed-use settin...
Continue Reading

FAQ ID: 1384

Last Modified: 09/30/2020

Q: If a 340B covered entity is part of an umbrella company structure and the providers are employed by a different company under the same umbrella structure, can they still prescribe 340B drugs on behalf of the covered entity?

A: Consider whether the health care provider is either employed by the covered entity or provides health care under contractual or other arrangements (e.g. referral for consultation) such that responsibility for the care provided remains with the covered entity. 340B drugs may be used provided all 340B...
Continue Reading

FAQ ID: 1423

Last Modified: 09/30/2020

Q: What is a compliant way to utilize 340B anesthesia gases in a mixed-use setting?

A: 340B covered entities are responsible for maintaining auditable records which demonstrate that 340B drugs, including gases, are only provided to 340B eligible patients. As a best practice, standard operating procedures would address calculation of the amount of anesthesia gas used, the basis for det...
Continue Reading

FAQ ID: 1435

Last Modified: 09/30/2020

Q: Are employees of a covered entity eligible to receive 340B drugs?

A: Covered entities may only distribute 340B drugs to their employees who are eligible patients of the covered entity meeting all 340B program requirements. The 340B Program is limited to patients of the covered entity and has never been a general employee pharmacy benefit or self-insured organization ...
Continue Reading

FAQ ID: 1454

Last Modified: 09/30/2020

Q: If a 340B hospital loses its 340B eligibility, but later regains eligibility, may the hospital retrospectively place orders for replenishment of product based upon patient visits during its former eligibility period?

A: These scenarios are addressed on a case by case basis. Covered entities in these situations are encouraged to contact Apexus Answers for technical assistance.

FAQ ID: 1493

Last Modified: 09/30/2020

Q: If we refer a patient to an outside clinic, can we fill their prescriptions from our 340B clinic?

A: A covered entity may refer an individual for consultation to an outside clinic not registered for the 340B Program and consider that patient 340B eligible if the individual receives health care from a health care professional who is either employed by the covered entity or provides health care under...
Continue Reading

FAQ ID: 1526

Last Modified: 09/30/2020

Q: Are covered entities permitted to determine inpatient vs. outpatient status?

A: Yes. Covered entities may determine inpatient vs. outpatient status such that the determination is in compliance with all 340B Program requirements. Decisions regarding inpatient and outpatient status must be auditable, transparent, and consistently followed. Covered entities should establish writte...
Continue Reading

FAQ ID: 1535

Last Modified: 09/30/2020

Q: Does the 340B discount apply to Medicaid patients?

A: Payer status is not a determining factor for 340B patient eligibility. In other words, a patient is not disqualified from being a 340B eligible patient due to their payer status (third party payer, Medicare, Medicaid, uninsured, etc.). However, when a covered entity is providing 340B drugs to its Me...
Continue Reading

FAQ ID: 1559

Last Modified: 09/30/2020

Q: May a hospital use 340B-priced drugs in mixed-use settings, such as a surgery department, where both inpatients and outpatients are treated? If so, what if the hospital cannot track which drugs are used for inpatients and which ones are used for outpatients?

A: A hospital may use 340B drugs for eligible patients. The hospital must develop appropriate tracking systems to ensure that covered outpatient drugs purchased through the 340B Program are only used for eligible outpatients. It is the responsibility of the hospital to ensure appropriate safeguards are...
Continue Reading

FAQ ID: 1563

Last Modified: 09/30/2020

Q: Can 340B drugs be used for discharge prescriptions?

A: 340B drugs can be used for discharge prescriptions to the extent that the drugs are for outpatient use. Whether a drug qualifies as outpatient and the individual meets the definition of patient depends upon the factual circumstances surrounding the care of that particular individual. If a covered en...
Continue Reading

FAQ ID: 1565

Last Modified: 09/30/2020

Q: Is a covered entity grantee limited to using or prescribing drugs that address the services or range of services for which grant funding was received?

A: The 340B Program does not limit the drugs a covered entity can use or prescribe; however, 340B drugs may only be provided to individuals who are patients of the covered entity grantee. All components of the 340B patient definition (61 Fed. Reg. 55156 (October 24, 1996)) should be considered, includi...
Continue Reading

FAQ ID: 1568

Last Modified: 09/30/2020

Q: Are 318 grantees (STD grantees) that participate in the 340B Program permitted to purchase contraceptives and other 340B drugs for use by grantee patients?

A: STD (318 grantee) clinics participating in the 340B Program may purchase and dispense 340B drugs (including prescribed contraceptives) to eligible individuals receiving a service consistent with the scope of grant.

FAQ ID: 1599

Last Modified: 09/30/2020

Q: When there is an individual who is an eligible patient of two different 340B covered entities, which entity should claim that individual as a patient?

A: To the extent that an individual qualifies as a patient of both covered entities, HRSA expects the entities to resolve the issue in good faith. In cases where a covered entity purchased and dispensed a 340B drug to an individual, no other covered entity is permitted to replenish or otherwise assert ...
Continue Reading

FAQ Search

340B Patient Definition

How Can We Help?