Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress established that several conditions of compliance must be satisfied for a provider to access 340B pricing. Among other things, if a participating provider is out of compliance with either the statutory prohibition on Medicaid rebate-340B discounting duplication (hereinafter, “Medicaid-340B duplication”) or the statutory prohibition on diversion, it is no longer a “covered entity” eligible for 340B pricing. There is also no obligation to offer 340B pricing multiple times on the same unit.
BIO supports CMS’ commitment to improving the quality and delivery of care in the MA and Part D programs. We believe it is critically important to ensure that policies in these programs advance patient access to timely and appropriate treatment,…
On January 25, BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS') Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses Proposed Rule. BIO is extremely…
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress established that several conditions of compliance must be satisfied for a provider to access 340B pricing. Among other things, if a participating provider is out of compliance with either the statutory prohibition on Medicaid rebate-340B discounting duplication (hereinafter, “Medicaid-340B duplication”) or the statutory prohibition on diversion, it is no longer a “covered entity” eligible for 340B pricing. There is also no obligation to offer 340B pricing multiple times on the same unit.