Q: How should we bill our Medicaid agency for fee-for-service (FFS) Medicaid when we use 340B drugs to fill Medicaid prescriptions?
A: HRSA recommends that covered entities refer to their respective state Medicaid agency drug reimbursement guidelines for applicable billing requirements. See ... HRSA recommends that covered entities refer to their respective state Medicaid agency drug reimbursement guidelines for applicable billing requirements. See https://www.hrsa.gov/sites/default/files/hrsa/opa/federal-register-12-15-2000.pdf.
In addition, to improve transparency and assist stakeholders with 340B compliance, the 340B Prime Vendor has gathered 340B Medicaid information from multiple federal and state Medicaid sources and compiled them in one location. Access this valuable resource here: https://www.340bpvp.com/resource-center/medicaid Continue Reading
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... 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 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. 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: 2042
Last Modified: 07/31/2020
Q: Absent HRSA guidance, what actions should covered entities take regarding the prevention of duplicate discounts for drugs billed to Medicaid managed care organizations (MCO)?
A: Duplicate discounts are prohibited for Medicaid FFS and MCO drugs pursuant to section 340B(a)(5)(A) of the Public Health Service Act. The data included in the Medicaid Exclusion File (MEF) applies to drugs billed under Medicaid fee-for-service (FFS). HRSA encourages covered entities to work with sta... Duplicate discounts are prohibited for Medicaid FFS and MCO drugs pursuant to section 340B(a)(5)(A) of the Public Health Service Act. The data included in the Medicaid Exclusion File (MEF) applies to drugs billed under Medicaid fee-for-service (FFS). HRSA encourages covered entities to work with states and their respective MCOs to develop strategies to prevent duplicate discounts. In some cases, states have placed certain requirements on covered entities regarding the prevention of duplicate discounts for drugs billed to MCOs.
Covered entities report using a variety of methods to prevent duplicate discounts for MCO claims. For example, identification of MCOs by bank identification numbers (BIN) and/or processor control numbers (PCN); use of National Council for prescription Drug Programs (NCPDP) codes for claims submitted through a pharmacy operating system; use of claim modifier codes for physician administered drugs; and submission of drug costs as part of a bundled or capitated rate. Continue Reading
FAQ ID: 2693
Last Modified: 04/17/2020
Q: Can a covered entity use 340B for discharge prescriptions from a child site hospital that does not have outpatient clinics to register?
A: Discharge prescriptions may be allowable to the extent they are for outpatient use and originated from an inpatient unit of a 340B covered entity participating in the 340B Program. Covered entities are responsible to maintain auditable records.
FAQ ID: 1496
Last Modified: 12/27/2019
Q: Our contract pharmacy uses a repackager at a separate address from the contract pharmacy to process 340B prescriptions. Must we register the repackager on 340B OPAIS?
A: The covered entity is not required to register the repackager as a contract pharmacy so long as:
(1) the covered entity retains ownership and title to the 340B drugs; (2) the covered entity will not sell its 340B drugs or otherwise transfer ownership to the repackager; and (3) the ... The covered entity is not required to register the repackager as a contract pharmacy so long as:
(1) the covered entity retains ownership and title to the 340B drugs; (2) the covered entity will not sell its 340B drugs or otherwise transfer ownership to the repackager; and (3) the repackager will not dispense 340B drugs.
Based on those specific circumstances, and the fact that the repackager is not a pharmacy and will not dispense drugs, OPA does not require the repackager to register as a contract pharmacy. Continue Reading
FAQ ID: 1697
Last Modified: 11/01/2019
Q: Are over-the-counter (OTC) drugs distributed without a written prescription and provided to walk-ins in an in-house or contract pharmacy owned by a DSH hospital considered covered outpatient drugs?
A: No. Section 340B(a)(2)(B)(ii) of the PHS Act states “the term ‘over the counter drug’ means a drug that may be sold without a prescription and which is prescribed by a physician (or other persons authorized to prescribe such drug under State law).” Thus, OTC drugs that are distributed pursuant to a ... No. Section 340B(a)(2)(B)(ii) of the PHS Act states “the term ‘over the counter drug’ means a drug that may be sold without a prescription and which is prescribed by a physician (or other persons authorized to prescribe such drug under State law).” Thus, OTC drugs that are distributed pursuant to a prescription are considered covered outpatient drugs. Continue Reading
FAQ ID: 1249
Last Modified: 11/10/2014
Q: If two different 340B entities are using the same contract pharmacy, would it be considered non-compliance if a patient’s visit of both of the entities generates a 340B eligible prescription at one entity, but both entities claim replenishment?
A: Two different 340B covered entities cannot generate a 340B eligible prescription and claim replenishment for the same drug. Claiming replenishment credit for a drug that has already been given to a 340B eligible patient by another 340B covered entity is diversion. Be advised HRSA has the authority t... Two different 340B covered entities cannot generate a 340B eligible prescription and claim replenishment for the same drug. Claiming replenishment credit for a drug that has already been given to a 340B eligible patient by another 340B covered entity is diversion. Be advised 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: 1370
Last Modified: 11/10/2014
Q: Can drugs purchased under the 340B program be used with Medicare Part D?
A: Yes; nothing in the MMA or 340B statutes or guidelines prevents drugs purchased under the 340B pricing program from being used to fill Medicare Part D prescriptions.
FAQ ID: 1311
Last Modified: 11/07/2014
Q: Must an over-the-counter (OTC) drug be prescribed to be subject to 340B pricing?
A: Yes. An OTC drug must be prescribed if purchased under the 340B Program. Section 340B(a)(2)(B)(ii) of the Public Health Service Act states “[t]he term ‘over the counter drug’ means a drug that may be sold without a prescription and which is prescribed by a physician (or other persons authorized to... Yes. An OTC drug must be prescribed if purchased under the 340B Program. Section 340B(a)(2)(B)(ii) of the Public Health Service Act states “[t]he term ‘over the counter drug’ means a drug that may be sold without a prescription and which is prescribed by a physician (or other persons authorized to prescribe such drug under State law).” Continue Reading
FAQ ID: 1506
Last Modified: 11/05/2014
Q: Can an ADAP covered entity request a rebate on a drug that was purchased at or below the 340B ceiling price by another covered entity?
A: No. An ADAP is not entitled to request a 340B rebate from a manufacturer where the sale of the drug was at or below the 340B ceiling price. It is also necessary for an ADAP to exclude any prescription reimbursements from rebate claims that an ADAP has made to covered entities purchasing drugs at the... No. An ADAP is not entitled to request a 340B rebate from a manufacturer where the sale of the drug was at or below the 340B ceiling price. It is also necessary for an ADAP to exclude any prescription reimbursements from rebate claims that an ADAP has made to covered entities purchasing drugs at the 340B point of purchase discount. Continue Reading
FAQ ID: 1588
Last Modified: 08/11/2013
Q: Does the Prime Vendor Program negotiate inpatient discounts for its DSH participants?
A: The PVP does not negotiate inpatient pricing. Its efforts are dedicated to outpatient products and services. Medicare prescription drug legislation has extended Medicaid best price exemption to disproportionate share hospitals’ inpatient drug purchases. Previously, the pricing exemption only appl... The PVP does not negotiate inpatient pricing. Its efforts are dedicated to outpatient products and services. Medicare prescription drug legislation has extended Medicaid best price exemption to disproportionate share hospitals’ inpatient drug purchases. Previously, the pricing exemption only applied to the disproportionate share hospitals’ outpatient drug purchases. The change enables pharmacy manufacturers to voluntarily offer “340B like” pricing to DSHs within their inpatient settings. The DSHs can secure additional discounts on inpatient drugs through their existing GPOs or by negotiating discounts independently with manufacturers. Continue Reading
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