Q: Does the gpo Prohibition apply to covered entity owned pharmacies?
A: The gpo prohibition applies to covered entity sites which are registered for the 340B Program. The covered entity should not try to circumvent the gpo Prohibition by accessing gpo purchased drugs via an entity-owned pharmacy or contract pharmacy in a 340B registered location. For additional informat... The gpo prohibition applies to covered entity sites which are registered for the 340B Program. The covered entity should not try to circumvent the gpo Prohibition by accessing gpo purchased drugs via an entity-owned pharmacy or contract pharmacy in a 340B registered location. For additional information, please review: The Statutory Prohibition on Group Purchasing Organization Participation Policy Release https://www.hrsa.gov/sites/default/files/hrsa/opa/prohibition-gpo-participation-02-07-13.pdf The covered entity is expected to have written policies and procedures and maintain auditable records demonstrating compliance with all 340B Program requirements. Continue Reading
FAQ ID: 1349
Last Modified: 08/02/2022
Q: Can a 340B covered entity transfer 340B drugs to another 340B covered entity site, if both are part of the same healthcare system?
A: No. A 340B covered entity is prohibited from transferring 340B drugs to anyone other than a patient of that covered entity. Accordingly, one 340B covered entity cannot transfer a 340B drug to patients of a different covered entity. Under the statute, health care delivery systems to which an eligibl... No. A 340B covered entity is prohibited from transferring 340B drugs to anyone other than a patient of that covered entity. Accordingly, one 340B covered entity cannot transfer a 340B drug to patients of a different covered entity. Under the statute, health care delivery systems to which an eligible 340B covered entity may belong are not included in the statute as eligible entities. 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: 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: 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.
A: To create an account in 340B OPAIS, please use the following steps: 1. From the 340B OPAIS home page, click the “I am a Participant” icon or click the “Login” icon in the top menu. 2. Click the “Create new account” link. 3. &... To create an account in 340B OPAIS, please use the following steps: 1. From the 340B OPAIS home page, click the “I am a Participant” icon or click the “Login” icon in the top menu. 2. Click the “Create new account” link. 3. Type your email address in the space provided and click “Search.” 4. The “Create a New User” registration page will be displayed: a. If your email address is currently associated with an active or approved covered entity or manufacturer record as an AO or PC, your email address, name, title, organization (if available), phone number and extension will be populated automatically. b. If your email address has not been previously associated with a covered entity or manufacturer, enter your name, title, organization name (employer), phone number, and extension in the spaces provided before proceeding. All fields are required except phone extension. 5. For “Parent Entity Type,” select either covered entity or manufacturer. 6. Type your password and then type it again to confirm. 7. Type the CAPTCHA code displayed in the image in the text box. 8. Click “Register.” The 340B OPAIS will check for an existing account with your email address and validate the account. OPA Staff will review new user account requests and confirm or deny access to the 340B record. These steps along with your account validation activity are found in the 340B OPAIS Public User Guide on the 340B website (https://340bopais.hrsa.gov/help/Home.htm) specifically the section on creating an account. Continue Reading
FAQ ID: 1259
Last Modified: 09/29/2021
Q: If a disproportionate share hospital, children’s hospital, or freestanding cancer hospital registers to participate in the 340B Program, when does their participation become effective and the gpo prohibition apply?
A: The hospital’s authorizing official upon enrollment attests that the hospital “will not participate in a group purchasing organization or group purchasing arrangement for covered outpatient drugs as of the date of this listing on the OPA website.”
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... 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 determining the amount replenished, and the ability to ensure 340B drugs are tracked to specific eligible patients through auditable records. Two operational options for entities subject to the gpo prohibition to consider are to: maintain a separate and distinct physical inventory for inpatients (gpo) and 340B eligible outpatients (340B), or utilize a central WAC account to make an initial purchase of product to later be replenished for inpatients (with inpatient gpo) or for 340B eligible outpatients (with 340B). 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 ... 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 pharmacy benefit. Evidence of an employer relationship or insurer relationship alone is insufficient to determine 340B patient eligibility. Covered entities should document in policies and procedures and maintain auditable records. Continue Reading
FAQ ID: 1242
Last Modified: 09/14/2020
Q: When a covered entity is unable to purchase a covered outpatient drug at a 340B price, may the covered entity subject to the gpo prohibition buy via a gpo?
A: A covered entity that is subject to the gpo prohibition may not use a gpo for covered outpatient drugs at any point in time. However, if a covered entity is unable to purchase a covered outpatient drug at the 340B price, they should first try and work with the manufacturer to obtain the product at t... A covered entity that is subject to the gpo prohibition may not use a gpo for covered outpatient drugs at any point in time. However, if a covered entity is unable to purchase a covered outpatient drug at the 340B price, they should first try and work with the manufacturer to obtain the product at the 340B price. If they are still unable to obtain the product at the 340B price, they should then try to obtain the product at WAC. If they are also unable to purchase the product at WAC, entities may use a gpo only if they then immediately notify OPA detailing the covered outpatient drug(s) involved, the manufacturer, and the communication between the parties as to why the product was not available at 340B or WAC, by submitting the HRSA Template Notification Tool: Unavailable 340B Price https://www.340bpvp.com/Documents/Public/340B%20Tools/340B-ceiling-price-unavailable-incorrect-340b-ceiling-price-notification-for-hrsa.docx. In situations where a product is unavailable at 340B or WAC, and the covered entity can document that all other options have been exhausted, the covered entity should maintain auditable records demonstrating the circumstance, and show they attempted to purchase the product at 340B every time an order was made. Covered entities may not use the fact that they were unable to obtain a product on one day, to then use a gpo for an extended period of time. Continue Reading
FAQ ID: 1253
Last Modified: 09/14/2020
Q: Under what circumstances would OPA allow multiple grantee sites registered as different 340B IDs with the same grant number purchase 340B drugs under one account and share 340B inventory (for example, several Title X sites/340B IDs under the same Title X grant)?
A: Each covered entity with a 340B ID is considered a separate entity for purposes of the 340B Program. HRSA assigns 340B IDs in order for stakeholders to confirm eligibility and appropriate shipment of 340B drugs. Due to the complex nature of grantees (other than health centers) and their organizati... Each covered entity with a 340B ID is considered a separate entity for purposes of the 340B Program. HRSA assigns 340B IDs in order for stakeholders to confirm eligibility and appropriate shipment of 340B drugs. Due to the complex nature of grantees (other than health centers) and their organizational structures and relationships, the sharing of 340B inventory across 340B IDs is not allowed unless first approved by HRSA. HRSA will consider approval of inventory sharing between unique 340B IDs on a case-by-case basis. Grantees may submit a written request to HRSA to purchase 340B inventory through one account and distribute the inventory to multiple 340B IDs, including a proposal on how the model would ensure all 340B requirements are met.
Q: What are the audit and compliance parameters under the contract pharmacy guidelines?
A: HRSA audits of covered entities include contract pharmacy arrangements. The covered entity must have fully auditable records that demonstrate compliance with all 340B Program requirements and the entity remains responsible for ensuring their contract pharmacy arrangements meet statutory obligation... HRSA audits of covered entities include contract pharmacy arrangements. The covered entity must have fully auditable records that demonstrate compliance with all 340B Program requirements and the entity remains responsible for ensuring their contract pharmacy arrangements meet statutory obligations to ensure against diversion or duplicate discounts. HRSA recommends that covered entities perform quarterly internal audits and annual independent audits (or more frequent as necessary) of all their utilized contract pharmacies to ensure 340B Program compliance. HRSA also recommends that covered entities maintain written policies and procedures to describe contract pharmacy oversight activities, including effective procedures for review of the patient eligibility determination system used at contract pharmacies, and reconciliation of dispensing, purchasing, and billing records to ensure that diversion and duplicate discounts have not occurred.
If the covered entity determines that drug diversion or duplicate discounts occurred or that it is otherwise unable to comply with its responsibility to reasonably ensure compliance, the covered entity can you use this Self Disclosure tool to disclose the violation to HRSA https://www.340bpvp.com/Documents/Public/340B%20Tools/self-disclosure-to-hrsa-and-manufacturer-template.docx . This information should be mailed to: Health Resources and Services Administration, Office of Pharmacy Affairs, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857. Continue Reading
FAQ ID: 1598
Last Modified: 09/09/2020
Q: Can you recommend a vendor for our 340B site to work with in purchasing 340B drugs?
A: All wholesalers are permitted to serve 340B covered entities as drug vendors. Apexus currently has the exclusive agreement with HRSA to serve as the official 340B Prime Vendor for participating covered entities. It continues to expand the number of pharmacy distributors and covered entities partic... All wholesalers are permitted to serve 340B covered entities as drug vendors. Apexus currently has the exclusive agreement with HRSA to serve as the official 340B Prime Vendor for participating covered entities. It continues to expand the number of pharmacy distributors and covered entities participating in the program by using its expertise in negotiating below 340B ceiling pricing, developing efficient distribution networks and competitive bidding processes. The 340B Prime Vendor Program is voluntary, free of charge to entities, and designed to allow entities to participate in the program while still using their current drug distributor. For more information, contact the 340B Prime Vendor Program/Apexus at 888-340-2787 or visit their web site at 340bpvp.com Continue Reading
FAQ ID: 1670
Last Modified: 09/09/2020
Q: My facility is already participating in the 340B Prime Vendor Program. How do I make updates to my profile?
A: Participants are able to update their facility’s information at any time by visiting www.340BPVP.com. From the home page of the website, in the upper right hand corner click on “Login”. Once you are logged in to the secure section of the PVP website, in the same area, upper right hand corner, click... Participants are able to update their facility’s information at any time by visiting www.340BPVP.com. From the home page of the website, in the upper right hand corner click on “Login”. Once you are logged in to the secure section of the PVP website, in the same area, upper right hand corner, click the arrow next to your name, and select “My Profile”. If you do not see all entities associated with your organization, please contact Apexus Answers at ApexusAnswers@340BPVP.com or (888) 340-2787 to have your organizations linked correctly. You can update information in the “Apexus Prime Vendor Program (PVP) Participant Data” section at any time. To make updates in the “HRSA Office of Pharmacy Affairs Data” section, you must submit a 340B Change Request to OPA. If you are a PVP participant but do not have access to the secure section of the website, visit: https://www.340bpvp.com/covered-entities/pvp-entity-enrollment .Simple and easy online process to get access to PVP pricing, reports, contract updates and more! 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: 4310
Last Modified: 07/23/2020
Q: If our covered entity site only bills 340B drugs to Medicaid Managed Care Organizations, how should we answer the Medicaid billing question in 340B OPAIS that is used to populate the Medicaid Exclusion File?
A: The covered entity site should answer “no” to the Medicaid billing question in 340B OPAIS. The data included in the Medicaid Exclusion File (MEF) applies to drugs billed under Medicaid fee-for-service (FFS).
Duplicate discounts are prohibited for Medicaid FFS and MCO drugs pursuant to sec... The covered entity site should answer “no” to the Medicaid billing question in 340B OPAIS. The data included in the Medicaid Exclusion File (MEF) applies to drugs billed under Medicaid fee-for-service (FFS).
Duplicate discounts are prohibited for Medicaid FFS and MCO drugs pursuant to section 340B(a)(5)(A) of the Public Health Service Act. HRSA recognizes the need to address covered entities’ role in preventing duplicate discounts when 340B drugs are billed to MCOs. Absent policy on MCOs, 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. Continue Reading
FAQ ID: 1388
Last Modified: 07/22/2020
Q: Can a covered entity that participates in the Prime Vendor Program and carves out Medicaid use any drug loaded to the 340B account for Medicaid patients?
A: Prime Vendor sub-ceiling pricing on covered outpatient drugs in the 340B account must be excluded from use for covered entities that carve out Medicaid. The 340B Prime Vendor Program's sub-ceiling PHS account prices are considered 340B drugs and all the same requirements apply. Other PVP contract pr... Prime Vendor sub-ceiling pricing on covered outpatient drugs in the 340B account must be excluded from use for covered entities that carve out Medicaid. The 340B Prime Vendor Program's sub-ceiling PHS account prices are considered 340B drugs and all the same requirements apply. Other PVP contract pricing loaded to the non-gpo/WAC account for hospitals subject to the gpo prohibition (PVP sub-WAC, Apexus Generics Program, etc.) may be used in a Medicaid carve-out situation. Continue Reading
FAQ ID: 1241
Last Modified: 05/29/2020
Q: Can wholesalers / manufacturers refuse to ship to addresses listed in 340B OPAIS?
A: 340B OPAIS is the official source for 340B covered entity information. Billing and shipping addresses listed in 340B OPAIS provide manufacturers and wholesalers positive assurance that the purchasing/receiving site is eligible to obtain 340B drugs. Covered entities are responsible for ensuring that ... 340B OPAIS is the official source for 340B covered entity information. Billing and shipping addresses listed in 340B OPAIS provide manufacturers and wholesalers positive assurance that the purchasing/receiving site is eligible to obtain 340B drugs. Covered entities are responsible for ensuring that the billing and shipping address information in 340B OPAIS is up to date, and OPA verifies each shipping address listed in the database. Continue Reading
FAQ ID: 1373
Last Modified: 05/28/2020
Q: What actions does HRSA expect an entity to take if it loses 340B Program eligibility?
A: Covered entities should stop purchasing 340B drugs immediately upon losing eligibility. The entity must complete a termination request on 340B OPAIS and answer the following three questions: 1) The date the entity became ineligible; 2) The circumstances surrounding the loss of eligibilit... Covered entities should stop purchasing 340B drugs immediately upon losing eligibility. The entity must complete a termination request on 340B OPAIS and answer the following three questions: 1) The date the entity became ineligible; 2) The circumstances surrounding the loss of eligibility; 3) The last date 340B drugs were purchased.
Covered entities should work with the manufacturer to determine the most appropriate method for handling. There may be several options for handling the drug inventory once eligibility is lost. These options will depend upon the specific circumstances but may include transferring the inventory to an associated covered entity site/pharmacy that is still 340B registered, credit/rebill, return, or destruction according to state law. Covered entities should keep auditable records and ensure the process is transparent to manufacturers and wholesalers. Continue Reading
FAQ ID: 1652
Last Modified: 05/27/2020
Q: If a facility has contract pharmacies serving multiple child sites, does that pharmacy need to be registered on each individual child site's 340B OPAIS profile or is it sufficient to list under the parent site's profile only?
A: It will depend on the language in the contractual agreement between the pharmacy and the covered entity. If the agreement states that the contracted relationship applies to all entities of a specific organization and the parent site has been designated the billing entity for all of the child sites, ... It will depend on the language in the contractual agreement between the pharmacy and the covered entity. If the agreement states that the contracted relationship applies to all entities of a specific organization and the parent site has been designated the billing entity for all of the child sites, it is permissible for the contract pharmacy to be registered under the parent site only, thus not requiring child sites to register the contract pharmacy locations individually. 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
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