The Department of Health and Human Services (HHS) Office
of Inspector General (OIG) released a report on
July 1, 2019, finding that Medicare Part D contracts between Medicare
Prescription Drug Plan sponsors and drug manufacturers may have cost the
Medicare program nearly $75 million in 2014 alone due to lost rebates to the
Part D program sponsors for drugs filled at pharmacies associated with the 340B
discount drug program.
Under the terms of their contracts, drug manufacturers
pay negotiated rebates to Part D program sponsors for drugs dispensed to Part D
beneficiaries. These rebates reduce the Part D program sponsors’ costs, which
in turn reduces the amount that the Medicare program pays the plan sponsors. In
order to avoid giving both a discount to the 340B covered entity furnishing the
drug and a rebate to the Part D program sponsor, many negotiated contracts
between Part D program sponsors and drug manufacturers exclude from rebate
those drug prescriptions that were dispensed from 340B contract pharmacies and
the in-house pharmacies of 340B covered entities, often regardless of whether
the drug prescriptions were even dispensed to 340B eligible patients.
Because there is no prohibition on duplicate
discounts/rebates in the Part D drug context as there is in the Medicaid
context under the 340B program, drug manufacturers guard against the duplicate
discount through their Part D contract terms. However, because there is a lack
of specific identifiers on 340B drugs dispensed to Part D beneficiaries, many
manufacturers have negotiated a broad rebate carve-out that applies to all 340B
associated pharmacies, not just 340B program drugs. Because of this broad
carve-out, Part D program sponsors receive greater rebates if prescriptions are
filled at non-340B associated pharmacies.
The OIG’s report was not requested by a member of
Congress (a common motivation for such reports), nor does it offer any
recommendations by the OIG as to how to alleviate the issue identified by the
report (generally OIG reports suggest modifications to the reviewed scheme).
However, its factual conclusions suggest that the Medicare program could see significant
savings if manufacturers did not include the 340B pharmacy carve-out provisions
in their Part D contracts with sponsors or if coding was used for Part D
beneficiaries’ prescription drugs to identify 340B-eligible claims.
Additionally, one possible result of the OIG’s report could be that, in order
to maximize Part D rebates, all Part D prescription drug fulfillment could be
shifted away from 340B-associated pharmacies, which would rob 340B covered
entities of a portion of the financial benefit of their contract pharmacies.
340B covered entities, Part D program sponsors and drug manufacturers should
monitor the effects the OIG’s report has on their operations.
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