What is a “Pickle” hospital, and is it true that the 'greater than 11.75% disproportionate share adjustment percentage' requirement is waived for them?
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.”
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)?
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.
What is a ship to bill to arrangement?
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.
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?
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.
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?
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.
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?
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.
How does a manufacturer determine how many PPA Addenda to submit?
Manufacturers will submit a PPA Addendum for each PPA previously submitted to HRSA OPA. HRSA OPA understands that since the original PPA was signed, labeler codes may have been transferred, acquired, or purchased by other manufacturers. The manufacturer can determine the number of PPA Addenda that must be submitted by following these steps:
• Open the manufacturer search page on 340B OPAIS at https://340bopais.hrsa.gov/manufacturersearch
• Enter the manufacturer’s name into the “Manufacturer Name” field. A Manufacturer can see, based upon their name, how many labeler codes are listed for that specific manufacturer.
• The search results contain a “Signed Date” field.
• The number of “Signed Date” fields listed will determine the number of PPA Addenda required. Example: XYZ manufacturer performs a search by their name XYZ. Ten labeler codes appear under the name XYZ. Under the “Signed Date” field there are three unique dates representing the ten labeler codes 1/05/1993, 1/6/2005, and 12/15/2012. This indicates the number of original PPAs HRSA OPA has received from this manufacturer. HRSA OPA will then require receipt of three separate PPA Addenda to coincide with the original three PPAs.
How do I create my account in 340B OPAIS?
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://www.hrsa.gov/opa/files/publicuserguide.pdf) specifically the section on creating an account.
Who can perform pricing uploads and any requests for reconciliation?
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.