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 ... 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 https://www.hrsa.gov/sites/default/files/hrsa/opa/patient-entity-eligibility-10-24-96.pdf. 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. ... Covered entities should consider all aspects of patient definition in order to use 340B drugs. https://www.hrsa.gov/sites/default/files/hrsa/opa/patient-entity-eligibility-10-24-96.pdf Covered entities should consider whether the provider has covered entity admitting privileges in providing health care services to a patient of the covered entity such that the responsibility for the care provided remains with the covered entity. A non-covered entity provider’s admitting privileges to treat persons at a covered entity hospital alone is not sufficient to demonstrate that any person treated by that provider is a patient of the covered entity hospital for 340B Program purposes. Covered entities should address how they handle providers with privileges in their written policies and procedures. 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... 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 definition guidelines. For more information, please review OPA Accountable Care Organizations Policy Release, 2012-02, available at: https://www.hrsa.gov/sites/default/files/hrsa/opa/accountable-care-05-23-2012.pdf 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... 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 notice in the Federal Register found here: https://www.hrsa.gov/sites/default/files/hrsa/opa/patient-entity-eligibility-10-24-96.pdf 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... 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 health care; and •the individual receives health care services from a health care professional who 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; and •the individual receives a health care service or range of services from the covered entity which is consistent with the service or range of services for which grant funding or Federally-qualified health center look-alike status has been provided to the entity. Disproportionate share hospitals are exempt from this requirement. An individual will not be considered a patient of the covered entity if the only health care service received by the individual from the covered entity is the dispensing of a drug or drugs for subsequent self-administration or administration in the home setting.
Exception: Individuals registered in a State-operated or funded AIDS Drug Assistance Program (ADAP) that receives Federal Ryan White funding ARE considered patients of the participant ADAP if so registered as eligible by the State program.
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... 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 settings, they must either have a physically separate inventory or have an auditable accounting mechanism that can show the precise amounts given to every individual patient receiving 340B gases. HRSA has the authority to audit covered entities for compliance with 340B requirements (Section 340B (a)(5)(C) of the PHSA). 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... 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 entity uses 340B drugs, it should be able to explain why the covered entity is responsible for the use of the drugs on an outpatient basis and have auditable records that demonstrate compliance with 340B Program requirements 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... 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, including the provision that the individual receives a health care service or range of services from the covered entity which is consistent with the service or range of services for which grant funding or Federally-qualified health center look-alike status designation has been provided to the entity. Continue Reading
FAQ ID: 1265
Last Modified: 01/24/2020
Q: Which manufacturers and drugs are subject to 340B pricing, and can participating manufacturers offer only a subset of the drugs they manufacturer at 340B prices?
A: Manufacturers who participate in Medicaid are required to participate in the 340B Program and provide a 340B ceiling price for all covered outpatients drugs. To view which manufacturers participate in the 340B Program, please visit: ... Manufacturers who participate in Medicaid are required to participate in the 340B Program and provide a 340B ceiling price for all covered outpatients drugs. To view which manufacturers participate in the 340B Program, please visit: https://340bopais.hrsa.gov/searchlanding. A 340B participating manufacturer must provide a 340B price on all the covered outpatient drugs that meet the definition in section 1927(k) of the Social Security Act. Continue Reading
FAQ ID: 1288
Last Modified: 01/24/2020
Q: Can a hospital subject to the GPO prohibition use a GPO to purchase drugs that do not meet the definition of covered outpatient drug (as defined by section 1927(k) of the Social Security Act)?
A: Yes. Covered entities should maintain auditable records and policies and procedures related to the definition of covered outpatient drug and the use of a GPO that is consistent with the 340B statute.
FAQ ID: 1678
Last Modified: 01/24/2020
Q: Our mixed-use area has only inpatients or 340B eligible outpatients. We do not have any 340B ineligible patients. In this setting where the status of a patient (inpatient vs. outpatient) is not known until replenishment occurs by the split ordering software, and our accumulator splits orders into inpatient GPO and 340B, is it required to start with a WAC inventory?
A: The hospital must keep auditable records demonstrating that accumulation occurs for inpatient GPO or outpatient 340B for eligible patients (as defined by current patient definition guidelines (61Fed. Reg. 55156 (Oct. 24.1996)). A non-GPO outpatient account should be available for replenishment for c... The hospital must keep auditable records demonstrating that accumulation occurs for inpatient GPO or outpatient 340B for eligible patients (as defined by current patient definition guidelines (61Fed. Reg. 55156 (Oct. 24.1996)). A non-GPO outpatient account should be available for replenishment for covered outpatient drugs in the event a 340B product is not available. Continue Reading
FAQ ID: 2385
Last Modified: 01/24/2020
Q: Who is tasked with imposing civil monetary penalties against manufacturers who knowingly and intentionally overcharge a covered entity?
A: Pursuant to a delegation of authority, the HHS Office of the Inspector General (OIG) has the authority to impose CMPs utilizing the definitions, standards, and procedures under 42 CFR Parts 1003 and 1005, as applicable. For additional information, see the delegation of authority Federal Register Not... Pursuant to a delegation of authority, the HHS Office of the Inspector General (OIG) has the authority to impose CMPs utilizing the definitions, standards, and procedures under 42 CFR Parts 1003 and 1005, as applicable. For additional information, see the delegation of authority Federal Register Notice at https://www.gpo.gov/fdsys/pkg/FR-2017-01-05/pdf/2016-31944.pdf (82 FR 1356, January 5, 2017). Continue Reading
FAQ ID: 1286
Last Modified: 11/01/2019
Q: An infusion center is registered on 340B OPAIS as a participating child site and is listed as reimbursable on the most recently filed Medicare Cost Report of the entity. A drug for infusion is written at a non-eligible location, by a private physician with no relationship with the covered entity. May the hospital use 340B drugs in this scenario?
A: The hospital may use 340B drugs when all aspects of the patient definition are met. HRSA’s patient definition guidance states the individual must receive health care services from a health care professional who is either employed by the covered entity or provides health care under contractual or oth... The hospital may use 340B drugs when all aspects of the patient definition are met. HRSA’s patient definition guidance states the individual must receive health care services from a health care professional who 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 (61 Fed. Reg. 55156 (October 24, 1996)). HRSA’s patient definition guidance also states that an individual will not be considered a ‘patient’ of the covered entity if the only health care service received by the individual from the covered entity is the dispensing of a drug or drugs for subsequent self-administration or administration in the home setting (61 Fed. Reg. 55156, 55158 Oct. 24, 1996.) Continue Reading
FAQ ID: 1297
Last Modified: 11/01/2019
Q: If a drug manufacturer signs a pharmaceutical pricing agreement (PPA) with HRSA/OPA, is the manufacturer required to offer all of their products that have NDC numbers at 340B pricing, or does it depend on the product’s 5-digit NDC labeler code?
A: The PPA signed by the manufacturer covers all covered outpatient drugs that meet the definition in section 1927(k) of the Social Security Act for the manufacturer’s labeler code.
FAQ ID: 1355
Last Modified: 11/01/2019
Q: Can a hospital subject to the GPO Prohibition use a GPO for drugs that are part of/incident to another service and payment is not made as direct reimbursement of the drug (“bundled drugs”)? For example, diluents for infusions, large volume parenterals used as diluents, etc.
A: Yes, a GPO may be used for drugs that are not covered outpatient drugs. Covered entities should maintain auditable records and policies and procedures related to the definition of covered outpatient drug and the use of a GPO that is consistent with the 340B statute.
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