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... 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. Qualified service - patient location/service information from hospital billing reports with date/time stamp 3. Medication(s) used - corresponding copies of pharmacy orders with 11-digit NDC information, amount dispensed/administered as well as prescriber 4. Medication administration or dispensing time while patient was classified as outpatient (depending on what covered entity has defined in policies and procedures as time of patient status determination for 340B purposes). Examples include hospital billing reports, medication administration record, etc. This list is not all-inclusive, and may or may not be applicable based upon the unique situation of any particular entity. The elements included should support adherence to 340B Program requirements and must be clearly auditable. A combination of elements is recommended, as opposed to using any one factor individually. Continue Reading
FAQ ID: 1190
Last Modified: 05/12/2023
Q: Do clinics/departments/services located within the four walls of a registered 340B hospital have to be registered in 340B OPAIS?
A: Outpatient clinics/departments/services within the four walls (i.e. same physical mailing address) of the registered parent 340B hospital do not need to separately register/enroll into the 340B Program. However, the covered entity remains responsible for demonstrating that those outpatient clinics/d... Outpatient clinics/departments/services within the four walls (i.e. same physical mailing address) of the registered parent 340B hospital do not need to separately register/enroll into the 340B Program. However, the covered entity remains responsible for demonstrating that those outpatient clinics/departments/services are listed as reimbursable on the hospital’s most recently filed Medicare cost report, are only using 340B drugs for eligible outpatients, meet all 340B Program requirements, and maintain auditable records. Clinics/departments/services at an offsite location from the registered parent must separately register on 340B OPAIS, even if they are located within the four walls of that child site. This applies to hospitals that are registered as child sites - every eligible clinic which will purchase or use 340B drugs within such a hospital must register separately as a child site. Continue Reading
FAQ ID: 1193
Last Modified: 08/02/2022
Q: May an outpatient facility that is reimbursed by CMS as a provider based facility, but not included on the most recently filed Medicare cost report, participate in the 340B Program?
A: A facility must be both reimbursable and included in the hospital’s most recently filed Medicare cost report with associated outpatient costs and charges to access the 340B Program and register in 340B OPAIS. HRSA’s outpatient facility guidelines can be found at ... A facility must be both reimbursable and included in the hospital’s most recently filed Medicare cost report with associated outpatient costs and charges to access the 340B Program and register in 340B OPAIS. HRSA’s outpatient facility guidelines can be found at https://www.hrsa.gov/sites/default/files/hrsa/opa/outpatient-hospital-facilities-09-1994.pdf Continue Reading
FAQ ID: 1474
Last Modified: 08/02/2022
Q: Can a manufacturer audit a covered entity?
A: Yes, section 340B (a)(5)(C) of the PHS Act allows manufacturers to audit a covered entity to ensure compliance with 340B drug diversion and duplicate discount prohibitions and requires entities to permit manufacturers to audit records related to compliance with these prohibitions. A manufacturer m... Yes, section 340B (a)(5)(C) of the PHS Act allows manufacturers to audit a covered entity to ensure compliance with 340B drug diversion and duplicate discount prohibitions and requires entities to permit manufacturers to audit records related to compliance with these prohibitions. A manufacturer must first attempt to resolve issues in good faith with the covered entity. If good faith efforts fail, the manufacturer must submit an audit work plan and reasonable cause justification to HRSA prior to conducting the audit. For more information, please refer to the 340B Program Policy Release here: https://www.hrsa.gov/sites/default/files/hrsa/opa/manufacturer-audit-clarification-11-21-11.pdf. Continue Reading
FAQ ID: 1623
Last Modified: 09/13/2021
Q: What opportunity exists for the vendors to partner with the Apexus’ Prime Vendor Program?
A: The Apexus PVP is an outpatient pharmacy program that secures sub-340B contract pricing on medications that by law have a 340B statutory price. The PVP also contracts for other value-added products and services that an outpatient ambulatory pharmacy would use and/or dispense. If your products or s... The Apexus PVP is an outpatient pharmacy program that secures sub-340B contract pricing on medications that by law have a 340B statutory price. The PVP also contracts for other value-added products and services that an outpatient ambulatory pharmacy would use and/or dispense. If your products or services fall outside this scope, we are most likely unable to partner with you. Please contact John Barnes, Associate Vice President of Contracting Services at 469-299-7311 or via email at John.Barnes@Apexus.com. Continue Reading
FAQ ID: 1184
Last Modified: 05/29/2020
Q: How must we register our in-house pharmacy that is a separate legal entity under our 340B covered entity?
A: An in-house pharmacy is not eligible to register as a child site. The in-house pharmacy could be listed as a shipping address. If the covered entity has a contract with the in-house pharmacy because it is a separate legal entity, then it must be registered as a contract pharmacy and may not dispense... An in-house pharmacy is not eligible to register as a child site. The in-house pharmacy could be listed as a shipping address. If the covered entity has a contract with the in-house pharmacy because it is a separate legal entity, then it must be registered as a contract pharmacy and may not dispense any 340B drugs until a written contract is in place and the pharmacy is listed as a contract pharmacy for the covered entity on 340B OPAIS. Continue Reading
FAQ ID: 1181
Last Modified: 04/29/2020
Q: If a 340B covered entity hospital falls under common legal control of an umbrella organization, are all of the other hospitals falling under that same umbrella eligible for the 340B Program?
A: No. Common legal control of a covered entity does not extend 340B Program eligibility to all units of the umbrella organization. In other words, eligibility of part of an organization or system does not transfer eligibility to the whole. Entities are responsible for ensuring that only eligible facil... No. Common legal control of a covered entity does not extend 340B Program eligibility to all units of the umbrella organization. In other words, eligibility of part of an organization or system does not transfer eligibility to the whole. Entities are responsible for ensuring that only eligible facilities or units of their organization participate in the 340B Program and are encouraged to seek legal counsel to review their particular circumstance. In the case of 340B hospitals, the outpatient facility must be an integral part of the hospital and listed on the most recently filed Medicare cost report of the eligible 340B hospital. Continue Reading
FAQ ID: 1182
Last Modified: 04/29/2020
Q: Can a community health center (CHC) participate in the 340B Program only for the purpose of purchasing clinic-administered drugs?
A: Yes, a CHC can participate in the 340B Program to purchase its clinic-administered medications without operating an in-house retail pharmacy or contract pharmacy arrangement.
FAQ ID: 1420
Last Modified: 03/26/2020
Q: May a manufacturer require only 340B entities to purchase covered outpatient drugs through specialty distribution channels?
A: Consistent with section 340B(a)(1) of the PHSA, manufacturers are expected to provide the same opportunity for 340B covered entities and non-340B purchasers to purchase covered outpatient drugs when such drugs are sold through limited distributors or specialty pharmacies. This extends to the manner ... Consistent with section 340B(a)(1) of the PHSA, manufacturers are expected to provide the same opportunity for 340B covered entities and non-340B purchasers to purchase covered outpatient drugs when such drugs are sold through limited distributors or specialty pharmacies. This extends to the manner in which 340B drugs are made available to covered entities (e.g., direct sales versus through wholesalers, specialty pharmacies, or limited distributors.) Additional information can be found in the following Policy Release (Clarification of Non-Discrimination Policy. Release No. 2011-1.1 (May 23, 2012)). Manufacturers should notify HRSA of its intent to implement a specialty distribution channel to ensure compliance and ensure that entities are aware of the distribution channel for transparency and to limit any disputes. Continue Reading
FAQ ID: 2686
Last Modified: 03/25/2020
Q: What is the difference between the ceiling price and the package adjusted price?
A: The 340B ceiling price is defined in statute (section 340B(a)(1) of the Public Health Service Act) and implementing regulations (42 CFR §10.3 and §10.10(a)). The 340B ceiling price is the maximum statutory price a manufacturer can charge a covered entity for the purchase of a covered outpatient drug... The 340B ceiling price is defined in statute (section 340B(a)(1) of the Public Health Service Act) and implementing regulations (42 CFR §10.3 and §10.10(a)). The 340B ceiling price is the maximum statutory price a manufacturer can charge a covered entity for the purchase of a covered outpatient drug and is equal to the average manufacturer price (AMP) from the preceding calendar quarter for the smallest unit of measure minus the unit rebate amount (URA). HRSA calculates the 340B ceiling price at six decimal places and then subsequently publishes the 340B ceiling price in the 340B OPAIS rounded to two decimal places. HRSA also publishes a package adjusted price for each covered outpatient drug in the 340B OPAIS. HRSA publishes the package adjusted price as a courtesy to assist manufacturers and covered entities in evaluating the 340B ceiling price. The package adjusted price is calculated using the 340B ceiling price, the package size (PS), and the case pack size (CSP) for a covered outpatient drug, and represents the price that the covered entity actually pays for the drug.
Package Adjusted Price = (AMP – URA)* PS *CSP The PS is the quantity of a unit of measure contained in one package sold by a manufacturer under a particular 11 digit NDC. The CSP is the number of salable units in the shipping container. HRSA publishes the package adjusted price in 340B OPAIS rounded to two decimal places.
The exception to this rounding convention occurs when the 340B ceiling price is less than $0.01. In these cases, the 340B ceiling price rounded to two decimal places will be multiplied by the package size and case pack size to equal the package adjusted price. This is consistent with the Final Rule. Continue Reading
FAQ ID: 1177
Last Modified: 01/24/2020
Q: A DSH with an in-house pharmacy would like to serve 340B and non-340B eligible patients. May we use a GPO to purchase drugs for our non-340B eligible patients that receive services at sites registered on the 340B OPAIS?
A: No.
FAQ ID: 1217
Last Modified: 01/24/2020
Q: What is a “Pickle” hospital, and is it true that the "greater than 11.75% disproportionate share adjustment percentage" requirement is waived for them?
A: The 11.75% requirement is waived for a few hospitals known as "Pickle" hospitals (named for a JJ Pickle, a former member of Congress). They are defined in the Section 1886(d)(5)(F)(i)(II) of the Social Security Act as "a hospital that serves a significantly disproportionate number of low income pati... The 11.75% requirement is waived for a few hospitals known as "Pickle" hospitals (named for a JJ Pickle, a former member of Congress). They are defined in the Section 1886(d)(5)(F)(i)(II) of the Social Security Act as "a hospital that serves a significantly disproportionate number of low income patients and is located in an urban area, has 100 or more beds, and can demonstrate that its net inpatient care revenues (excluding any of such revenues attributable to this title or State plans approved under title XIX) during the cost reporting period in which the discharges occur, for indigent care from state and local government sources exceed 30 percent of its total of such net inpatient care revenues during the period.” Continue Reading
FAQ ID: 2382
Last Modified: 01/24/2020
Q: Which policies does the 340B Ceiling Price and CMP Regulation replace?
A: The 340B Ceiling Price and CMP Regulation replaces former "Clarification of Penny Pricing" policy release (2011-2 (November 21, 2011)) and the final guidelines in 1995 describing ceiling price calculations for new drugs [60 FR, 51488 (October 2, 1995)].
FAQ ID: 1187
Last Modified: 11/01/2019
Q: What are some examples of contracting approaches that are potential violations of the GPO Prohibition?
A: The following situations are not GPO-prohibition compliant contracting practices: - An individual DSH accessing contracts executed by an IDN, in which it is a member. - A wholesaler’s generic source program (unless offered as a subcontracted solution to the Apexus Generics Program) - A manufacturer ... The following situations are not GPO-prohibition compliant contracting practices: - An individual DSH accessing contracts executed by an IDN, in which it is a member. - A wholesaler’s generic source program (unless offered as a subcontracted solution to the Apexus Generics Program) - A manufacturer extending a discounted price to a group of covered entities (subject to the GPO prohibition) through a wholesaler, other third party or group purchasing arrangement, that is not supported by an individual contract between the 340B covered entity and the manufacturer. Such agreements should be reproducible for review during an audit of compliant 340B operations. Continue Reading
FAQ ID: 1188
Last Modified: 11/01/2019
Q: How soon after a drug is approved by the FDA is 340B pricing available?
A: The 340B price is available for a new covered outpatient drug as of the date the drug is first available for sale. For the purposes of the 340B Program, manufacturers must estimate the ceiling price using the methodology described in the 340B Ceiling Price and Civil Monetary Penalties (CMP) final ru... The 340B price is available for a new covered outpatient drug as of the date the drug is first available for sale. For the purposes of the 340B Program, manufacturers must estimate the ceiling price using the methodology described in the 340B Ceiling Price and Civil Monetary Penalties (CMP) final rule (82 FR 1210, January 5, 2017), which requires a new drug’s ceiling price to be estimated using wholesale acquisition cost minus the appropriate rebate percentage (i.e., 23.1% for most single-source and innovator drugs, 17.1% for clotting factors and 13% for generics) until sufficient data is available to calculate the actual 340B ceiling price of the new drug.
Once the average manufacturer price (AMP) is known, and no later than the fourth quarter that the drug is available for sale, manufacturers must calculate the actual 340B ceiling price based on the AMP. For more information on new drug price estimation, please review the 340B Ceiling Price and CMP final rule at: https://www.gpo.gov/fdsys/pkg/FR-2017-01-05/pdf/2016-31935.pdf. Continue Reading
FAQ ID: 1611
Last Modified: 11/01/2019
Q: Can Apexus to deem our process or our 340B vendor "340B compliant"?
A: The role of Apexus is to help entities understand complex policy situations and help point out areas of risk for non-compliance, as well as compliant approaches used by entities. Apexus is unable to provide assurances or statements of stakeholder compliance. Entities should contact their own legal... The role of Apexus is to help entities understand complex policy situations and help point out areas of risk for non-compliance, as well as compliant approaches used by entities. Apexus is unable to provide assurances or statements of stakeholder compliance. Entities should contact their own legal counsel, have auditable records and policies and procedures in place to reflect compliance with all 340B Program requirements.
Regarding vendors: Apexus has secured agreements to offer value-added pharmacy related products and services to its participants. Apexus has reviewed these services and deemed that they have the potential for promoting 340B compliance, but they may have features that entities choose to active or inactivate. For this reason, using a service on this list does not guarantee the entity will achieve 340B compliance and is not an Apexus endorsement. Continue Reading
FAQ ID: 2569
Last Modified: 11/01/2019
Q: What if a manufacturer notices a pricing discrepancy post 340B OPAIS publishing of prices for the quarter?
A: Manufacturers are to communicate any price discrepancies after publication to 340Bpricing@hrsa.gov. Please include the manufacturer name, contact information, labeler code, 11 digit NDC, and price discrepancy in your communication.
FAQ ID: 1191
Last Modified: 10/24/2019
Q: When a product's manufacturer changes the NDC (same manufacturer for the old and new NDC and same product) may we replenish the old NDC with the new NDC as long as we keep records?
A: If a replenishment model is utilized, then it is recommended that the covered entity accumulate 340B purchases for the exact NDC-11 (i.e., NDC and manufacturer) that was originally based on a 340B-eligible patient. The covered entity should have auditable records to demonstrate accumulation in a rep... If a replenishment model is utilized, then it is recommended that the covered entity accumulate 340B purchases for the exact NDC-11 (i.e., NDC and manufacturer) that was originally based on a 340B-eligible patient. The covered entity should have auditable records to demonstrate accumulation in a replenishment model. New products purchased as a new NDC will begin a new replenishment. Manufacturers and covered entities have worked together on mutually agreed to practices, and kept written auditable records. Continue Reading
FAQ ID: 1196
Last Modified: 04/10/2017
Q: Can a wholesaler load a GPO Private Label product in the WAC account at a WAC price?
A: No. The GPO private label product is not permitted to be loaded into the Non-GPO WAC or 340B accounts.
FAQ ID: 2211
Last Modified: 10/16/2015
Q: Our rural hospital participates in the 340B program and carves-in Medicaid. How should we handle not being able to purchase orphan drugs at a 340B price, when we have stated we bill Medicaid for 340B drugs? Orphan drugs are not covered outpatient drugs for us as a 340B entity, but Medicaid still views them as a covered outpatient drug. Must we carve-out?
A: Covered entities and states should work together in good faith to ensure duplicate discounts to do not occur.
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