Q: What are HRSA’s expectations regarding hospital eligibility and a contract with State or local government?
A: A hospital that is private, non-profit with a contract with a state or local government to provide health care services to low income individuals who are not entitled to benefits under Medicare or eligible for State Medicaid is eligible for the 340B Program. The hospital must be able to demonstrate ... A hospital that is private, non-profit with a contract with a state or local government to provide health care services to low income individuals who are not entitled to benefits under Medicare or eligible for State Medicaid is eligible for the 340B Program. The hospital must be able to demonstrate through official documentation that it is private non-profit (e.g. hospital’s charter, Articles of Incorporation, Bylaws, other documents from the State that may certify the hospital is non-profit, an official IRS-990 form or other official IRS documentation). A written contract must exist between the hospital and state or local government to demonstrate the hospital’s eligibility for the 340B Program. The contract should include names of the hospital and government agency, have signatures of hospital and government agency representatives, and include dates clearly indicating effective dates of the contract. HRSA will request a copy of the contract and documentation demonstrating non-profit status at registration. For more information on documentation requirements for hospital eligibility, visit https://www.hrsa.gov/opa/registration/hospital-registration-instructions. Continue Reading
FAQ ID: 2441
Last Modified: 08/02/2022
Q: How do I create my account in 340B OPAIS?
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: 1230
Last Modified: 09/30/2020
Q: If an entity is funded under more than one grant program that is eligible to participate in the 340B program, must the entity register all programs with the OPA (e.g., the entity is eligible as a title X Family Planning Clinic and Federally Qualified Health Center)?
A: Eligible entities should consider all program requirements when deciding how to register for the 340B Program and may register more than one grantee type. Entities may only provide 340B drugs to individuals receiving a service consistent with the scope of the grant program for which the entity is re... Eligible entities should consider all program requirements when deciding how to register for the 340B Program and may register more than one grantee type. Entities may only provide 340B drugs to individuals receiving a service consistent with the scope of the grant program for which the entity is registered. Please note that regular quarterly registration timelines apply, even if only adding or changing covered entity status. For more information on registration and deadlines, visit the Office of Pharmacy Affairs (OPA) web site at: https://340bopais.hrsa.gov//home 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 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: 1456
Last Modified: 01/24/2020
Q: What is a ship to bill to arrangement?
A: The ship to bill to procedure refers to an arrangement set up by the covered entity who is responsible for purchasing 340B drugs from wholesalers and/or manufacturers and directs those 340B drugs to be shipped to the contract pharmacy. In other words, the covered entity maintains title of the 340B d... The ship to bill to procedure refers to an arrangement set up by the covered entity who is responsible for purchasing 340B drugs from wholesalers and/or manufacturers and directs those 340B drugs to be shipped to the contract pharmacy. In other words, the covered entity maintains title of the 340B drugs, but the contract pharmacy houses the drugs and provides dispensing services to patients of the covered entity. Continue Reading
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: 1689
Last Modified: 11/01/2019
Q: What drugs are included under the 340B Drug Pricing Program?
Q: If an organization loses title X funding, but still has STD funding, what has to happen to the inventory purchased on the title X 340B account?
A: In general, the title X purchased 340B inventory should be returned or destroyed according to state law once the eligibility is lost under which the grantee/covered entity purchased the 340B medication. Inventory cannot be transferred from one 340B ID grantee/covered entity to another 340B ID grante... In general, the title X purchased 340B inventory should be returned or destroyed according to state law once the eligibility is lost under which the grantee/covered entity purchased the 340B medication. Inventory cannot be transferred from one 340B ID grantee/covered entity to another 340B ID grantee/covered entity when the former entity loses its 340B Program eligibility. Entities with extenuating circumstances should contact HRSA directly for possible alternatives to this approach. Continue Reading
FAQ ID: 2564
Last Modified: 11/01/2019
Q: Who can perform pricing uploads and any requests for reconciliation?
A: Only the Authorizing Official (AO) or Primary Contact (PC) listed for each labeler code in 340B OPAIS may perform the pricing upload, a complete the reconciliation process, and submit to OPA for review. The AO for a manufacturer labeler code record is an individual who can legally bind the company ... Only the Authorizing Official (AO) or Primary Contact (PC) listed for each labeler code in 340B OPAIS may perform the pricing upload, a complete the reconciliation process, and submit to OPA for review. The AO for a manufacturer labeler code record is an individual who can legally bind the company to the terms of the Pharmaceutical Pricing Agreement and is delegated the authority to perform tasks on behalf of the manufacturer (usually of the CEO/CFO/VP/SVP/Executive Director title). The PC is an employee of the manufacturer. Consultants are not authorized to be listed an AO or PC of a manufacture labeler code record. It is up to each manufacturer to ensure they have the right organizational personnel listed for each labeler code. 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: 1643
Last Modified: 08/11/2013
Q: How do I complete my Prime Vendor Program participation agreement when my clinic is registered as both a title X and Section 318 STD funded clinic?
A: If a clinic is eligible as both title X and Section 318 STD, you must complete two separate participation agreements. If you need to link these facilities to your profile, please contact Apexus Answers at (888) 340-2787 or ApexusAnswers@340bpvp.com.
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