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  • 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 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.)
  • FAQ ID: 1375
  • Last Modified: 09/15/2014
  • Q: May 340B drugs be used for individuals who are partners of patients being treated for an STD at a 340B covered entity?
  • A: 340B drugs may be used for STD partner therapy in situations meeting the 340B Patient Definition: Any patient of a participating 340B entity is considered a 340B patient provided that the following criteria are met: 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.
  • FAQ ID: 1458
  • Last Modified: 11/01/2019
  • Q: If a DSH and a CHC both claim 340B eligibility for a patient (for example, in the case of a referral), which entity can claim 340B eligibility?
  • A: Only one covered entity may claim 340B eligibility on a specific drug for a particular patient. The individual facts and circumstances of any situation will determine the application of patient definition. HRSA encourages the covered entities to work together, in good faith, to resolve any issues specific to claiming 340B eligibility for a patient. Covered entities that utilize replenishment must have systems in place that ensure that the drug dispensed was not already purchased under 340B and auditable records that demonstrate compliance.
  • FAQ ID: 1493
  • Last Modified: 09/15/2014
  • 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 only if the individual receives health care 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)). If the covered entity can document that it retained responsibility for the health care services provided to the referred individual, then that individual may be eligible to receive 340B drugs from the covered entity. How a covered entity counts referrals under the 340B Program should be addressed in their written policies and procedures.
  • FAQ ID: 1642
  • Last Modified: 02/10/2014
  • 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 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.

    For more information: Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Patient and Entity Eligibility (http://www.hrsa.gov/opa/programrequirements/federalregisternotices/patientandentityeligibility102496.pdf)
  • FAQ ID: 1669
  • Last Modified: 01/24/2020
  • Q: If my critical access hospital enrolls and participates in the 340B Program, will we have to stop participating in our group purchasing organization (GPO)?
  • A: No. Under section 340B(a)(4)(N) of the Public Health Service Act, as amended by the Affordable Care Act, the prohibition against participation in GPO arrangements does not apply to critical access hospitals, rural referral centers, or sole community hospitals. The GPO prohibition only applies to 340B-enrolled disproportionate share hospitals, children's hospitals, and free-standing cancer hospitals.
  • FAQ ID: 2207
  • Last Modified: 10/16/2015
  • Q: To whom does the orphan drug exclusion apply?
  • A: The exclusion of drugs with orphan indications applies to free-standing cancer hospitals, rural referral centers, sole community hospitals, and critical access hospitals. The exclusion does not apply to covered entities that meet the 340B Program eligibility requirements and are enrolled under sections 340B(a)(4)(A) through 340B(a)(4)(L) of the PHSA or to a children’s hospital described in section 340B(a)(4)(M). Furthermore, if a hospital potentially qualifies under more than one section, such as a 340B(a)(4)(L) disproportionate share hospital and 340B(a)(4)(O) sole community hospital, the hospital selects under which enrollment type it chooses to qualify. During the registration and annual recertification processes, a covered entity certifies that it meets the requirements for such an enrollment type.

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