We have been following the 340B debate between the manufacturers and covered entities. The debate between manufacturers and covered entities discusses if it is fair for covered entities to be able to utilize multiple contract pharmacies to dispense 340B drugs to 340B patients as the 2010 HRSA guidance allows. Manufacturers are concerned that some of the underserved and uninsured patients, for which the 340B Program was created to benefit, are not receiving the price break they should be.
Because manufacturers cannot verify or control duplicate discounts on the 340B medications, they have been challenging contract pharmacy arrangements in their own way. “Lilly says it will provide 340B pricing on its insulin products, but only if the contract pharmacy does not mark up the drug or otherwise charge a dispensing fee. Lilly cites President Trump’s Executive Order for its justification for conditioning its sale based on what the contract pharmacy charges for the drug.” In response to the American Hospital Association’s (AHA)’s letter to several pharmaceutical companies, “Sanofi’s Senior Vice President Adam Gluck said he’s ‘surprised and disappointed’ by the group’s ‘unfounded claims and incendiary tone. Sanofi supports the 340B Program’s core objective of increasing access to outpatient drugs among [the] uninsured [and underserved] and is committed to strengthening the Program’s mission, a goal that is only supported and advanced through [Senofi’s] initiative to prevent duplicate discounts.’ Sanofi will continue to offer its drugs to all 340B covered entities. ‘At most, if a covered entity refuses to provide the requested data, [Sanofi] will restrict the entity’s use of contract pharmacy arrangements, but these entities will remain eligible to purchase at 340B prices for shipment to their own facilities,’” Gluck said. Lilly has allowed affected covered entities to email it for an application. Lilly has determined for a covered entity that lacks an in-house pharmacy to qualify for its 340B drug pricing, “the entity cannot have any pharmacies registered as ship-to sites in 340B OPAIS, the federal 340B program database.”
While HRSA has not engaged with the manufacturers as they continue to distribute notices and updates to covered entities. HRSA, on November 18, 2020, “[advanced] a final rule to the White House for approval, which was approved. The rules creates a binding administrative dispute resolution (ADR) process for the 340B Program.” The contents of the rule are still unknown.
Interested in joining the 340B Program? HRSA is allowing covered entities to apply to be a part of the 340B Program on a weekly basis.
As of now – because of this ongoing debate – it’s easiest for covered entities to have a 340B in-house pharmacy and to educate their patients about its in-house pharmacy. An in-house 340B Pharmacy that patients are aware of will work to increase the covered entities’ revenue and capture rate. Having a in-house 340B Pharmacy allows the covered entity to use its savings from the Program to implement other programs that benefit its patients.
No matter where you are on your 340B Pharmacy journey, we can assist with your 340B Pharmacy needs! From writing contracts with contract pharmacies, implementing and/or managing or overseeing your in-house 340B Pharmacy to ensure continued 340B status through internal and external audits of your program.