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Overview of the 340B Drug Pricing Program

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Endnotes<br />

1 According to <strong>the</strong> Health Resources and Services Administration’s interpretation <strong>of</strong> <strong>the</strong><br />

<strong>340B</strong> statute, CAHs, cancer hospitals, RRCs, and SCHs are prohibited from using orphan<br />

drugs under <strong>340B</strong> when <strong>the</strong> drugs are used for <strong>the</strong> rare disease or condition for which<br />

<strong>the</strong>y received an orphan designation (<strong>the</strong> orphan drug exclusion). Because claims data do<br />

not identify <strong>the</strong> indication for which a drug was used, we could not determine whe<strong>the</strong>r<br />

an orphan drug used by one <strong>of</strong> <strong>the</strong>se hospitals was eligible for <strong>340B</strong> discounted prices.<br />

Therefore, we excluded all orphan drugs used by <strong>the</strong>se types <strong>of</strong> hospitals.<br />

2 When <strong>the</strong> sequester began in April 2013, it reduced <strong>the</strong> amount that Medicare paid for all<br />

services by 2 percent. For separately payable drugs in <strong>the</strong> OPPS, Medicare normally pays<br />

80 percent <strong>of</strong> 1.06 × ASP, but <strong>the</strong> sequester reduces this to 80 percent <strong>of</strong> 1.039 × ASP.<br />

At <strong>the</strong> same time, Medicare beneficiaries are responsible for 20 percent <strong>of</strong> 1.06 × ASP,<br />

and <strong>the</strong> sequester has no effect on <strong>the</strong> beneficiary’s portion <strong>of</strong> <strong>the</strong> payment. The net effect<br />

<strong>of</strong> <strong>the</strong> sequester is to reduce <strong>the</strong> combined payment from Medicare and beneficiaries for<br />

separately payable drugs in <strong>the</strong> OPPS from 106 percent <strong>of</strong> ASP to 104.3 percent <strong>of</strong> ASP.<br />

For OPPS-covered drugs provided after <strong>the</strong> start <strong>of</strong> <strong>the</strong> sequester, we divided Medicare<br />

payments by 1.043 (ra<strong>the</strong>r than 1.06) to estimate <strong>the</strong> hospital acquisition cost.<br />

<strong>Overview</strong> <strong>of</strong> <strong>the</strong> <strong>340B</strong> <strong>Drug</strong> <strong>Pricing</strong> <strong>Program</strong> | May 2015 29

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