Q: Can a manufacturer place special conditions or restrictions on selling covered drugs to an entity at the 340B price that do not apply to non-340B purchasers?
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 distribution or specialty pharmacies. As outlined in the January ... 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 distribution or specialty pharmacies. As outlined in the January 2017 CMP final rule, manufacturers have an obligation to ensure that the 340B discount is provided through distribution arrangements made by the manufacturer. A manufacturer may not place limitations or conditions on the sale of covered outpatient drugs to covered entities under the 340B Program. HRSA issued a policy release clarifying non-discrimination in the Program, which can be found here: https://www.hrsa.gov/sites/default/files/hrsa/opa/non-discrimination-05-23-2012.pdf.
Manufacturers may continue to use limited distribution procedures provided that these arrangements follow HRSA’s 340B nondiscrimination policy. If a covered entity alleges it has been overcharged, HRSA will examine whether a manufacturer has submitted an alternate allocation plan to HRSA, whether this plan complies with the 340B nondiscrimination policy, and whether the manufacturer is following its plan. 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: 1565
Last Modified: 09/30/2020
Q: Is a covered entity grantee limited to using or prescribing drugs that address the services or range of services for which grant funding was received?
A: The 340B Program does not limit the drugs a covered entity can use or prescribe; however, 340B drugs may only be provided to individuals who are patients of the covered entity grantee. All components of the 340B patient definition (61 Fed. Reg. 55156 (October 24, 1996)) should be considered, includi... The 340B Program does not limit the drugs a covered entity can use or prescribe; however, 340B drugs may only be provided to individuals who are patients of the covered entity grantee. All components of the 340B patient definition (61 Fed. Reg. 55156 (October 24, 1996)) should be considered, including the provision that 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 designation has been provided to the entity. Continue Reading
FAQ ID: 2692
Last Modified: 09/30/2020
Q: Does HRSA require a child site hospital location to register inpatient locations with observation beds on HRSA’s 340B OPAIS?
A: HRSA does not require a child site hospital location to register inpatient locations with observation beds. However, if a child site hospital voluntarily submits a registration for an inpatient location with observation beds, OPA will review the registration and the hospital must provide Worksheets ... HRSA does not require a child site hospital location to register inpatient locations with observation beds. However, if a child site hospital voluntarily submits a registration for an inpatient location with observation beds, OPA will review the registration and the hospital must provide Worksheets A and C and the associated trial balance to support the registration. HRSA reserves the right to ask for additional supporting documentation if necessary. The 340B Program is an outpatient drug program. Enrolled covered entities have the responsibility to ensure that drugs purchased under the 340B Program be limited to outpatient use and provided only to eligible patients. HRSA acknowledges that 340B eligible patients may receive healthcare services in observation beds located in inpatient sections of the hospital. If a hospital uses 340B drugs for patients receiving healthcare in observations beds, the hospital must be able to explain how the covered entity is responsible for the use of the drugs on an outpatient basis and have auditable records and policies and procedures that demonstrate compliance with 340B Program requirements. Policies and procedures should specifically address how the hospital defines inpatient and outpatient for purposes of the 340B Program, and how that relates to observation beds. HRSA’s audits will ensure the hospital is following those policies and procedures. Continue Reading
FAQ ID: 1330
Last Modified: 04/29/2020
Q: Will HRSA accept data from a cost reporting period that is less than 12 months?
A: HRSA accepts data from the most recently completed, full cost reporting period that has been accepted by CMS. While the cost reporting period is usually 12 months, under certain limited circumstances CMS permits a full cost reporting period to be less than 12 months. HRSA will accept documentation ... HRSA accepts data from the most recently completed, full cost reporting period that has been accepted by CMS. While the cost reporting period is usually 12 months, under certain limited circumstances CMS permits a full cost reporting period to be less than 12 months. HRSA will accept documentation from the Hospital’s Fiscal Intermediary/Medicare Administrative Contractor demonstrating approval of the shortened cost reporting period. Continue Reading
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: 2446
Last Modified: 01/24/2020
Q: Can I still use 340B OPAIS if I am neither a participating covered entity or manufacturer? What information will I be able to access if I do not have a login account?
A: 340B OPAIS has public search and reports functionalities, with limited public viewing privileges, that will still be available. Covered entity, manufacturer, and contract pharmacy profiles are still accessible for public viewing. All registration, recertification, change and termination requests for... 340B OPAIS has public search and reports functionalities, with limited public viewing privileges, that will still be available. Covered entity, manufacturer, and contract pharmacy profiles are still accessible for public viewing. All registration, recertification, change and termination requests for covered entities and manufacturers can perform these actions in 340B OPAIS and are only accessible by their respective AO and PC. Continue Reading
FAQ ID: 1579
Last Modified: 11/01/2019
Q: Please clarify where I can utilize vaccines purchased through the 340B Prime Vendor Program (PVP).
A: Vaccines purchased through the PVP that are not covered outpatient drugs are classified as value-added products within the Prime Vendor Program. The use of vaccines purchased through the PVP are limited by the terms and conditions of the contract between the PVP and the supplier, including contractu... Vaccines purchased through the PVP that are not covered outpatient drugs are classified as value-added products within the Prime Vendor Program. The use of vaccines purchased through the PVP are limited by the terms and conditions of the contract between the PVP and the supplier, including contractual class of trade restrictions. In addition, entities must use vaccines purchased through PVP contracts for patients meeting the "own use" guidelines under the Nonprofit Institutions Act. Each entity should consult its independent legal counsel to ensure compliance with all rules, regulations, and contractual terms. Continue Reading
FAQ ID: 2547
Last Modified: 11/01/2019
Q: What are the steps for a manufacturer to upload the quarterly 340B pricing data?
A: A manufacturer AO or PC must log into the pricing component of the 340B OPAIS.
-Determine whether you plan to manually upload product data (recommended for limited drug products) or upload a product instrument file as .txt .
-Select Manufacturer Quarterly Data Processing > Up... A manufacturer AO or PC must log into the pricing component of the 340B OPAIS.
-Determine whether you plan to manually upload product data (recommended for limited drug products) or upload a product instrument file as .txt .
-Select the Sales Year and Sales Quarter to match the year and quarter of the data upload file.
-Click the Select button to navigate to the location of the manufacturer data file on your computer. Selecting the file will start the upload immediately.
-Click the Analyze Data button.
-The Data Upload Analysis page shows the file statistics for the upload, the number of rows inserted into the database, and the number and type of errors. Upon clicking the Process Files button, the system processes and loads the records and displays the Processing Upload page is displayed. Click the click here link to return to your dashboard. Continue Reading
FAQ ID: 2563
Last Modified: 11/01/2019
Q: Is each manufacturer limited to uploading one instrument file and including all labeler codes in that file?
A: Manufacturers may upload multiple times during the open period. Manufacturers may upload all of their labeler codes/products in one file or by each individual labeler/product. Manufacturers may also upload instrument files to correct reconciliation tasks. The 340B OPAIS will accept new values for... Manufacturers may upload multiple times during the open period. Manufacturers may upload all of their labeler codes/products in one file or by each individual labeler/product. Manufacturers may also upload instrument files to correct reconciliation tasks. The 340B OPAIS will accept new values for each instrument file upload. Continue Reading
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