NAVEOS® Reports HRSA Has Issued Final Rule on 340B Program Orphan Drug Exclusion

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NAVEOS

Jul 25, 2013, 04:00 ET

Chantilly, Virginia (PRWEB) July 25, 2013 -- The Patient Protection and Affordable Care Act (ACA) expanded 340B program eligibility to critical-access hospitals, sole community hospitals, rural referral centers and outpatient settings of certain free-standing cancer hospitals that met the program’s required disproportionate share (DSH) adjustment percentages. However, the ACA also included a provision that excluded these four types of hospitals from using 340B pricing to buy orphan drugs, which are used to treat rare diseases and conditions that affect fewer than 200,000 patients.

The final rule published by HRSA on July 23, 2013 now entitles these four types of ACA covered hospitals to the 340B discount price on an orphan drug - so long as these hospitals use the drug for a non-orphan indication. In order to protect the financial incentives for manufacturing orphan drugs, these hospitals are not allowed to use them for the rare condition or disease for which they were given an orphan drug designation, as specified in the Affordable Care Act. HRSA noted the rule follows congressional intent by both expanding what providers are eligible for within the 340B program, while protecting orphan drug manufacturer rights.

Also set forth in the final rule is the responsibility of the 340B program participant to maintain auditable records that demonstrate compliance with the terms of the orphan drug exclusion requirements. NAVEOS®, a healthcare data analytics firm in Northern Virginia, is advising all 340B participating hospitals to begin implementing auditable processes now with respect to the final rule mandates, effective on October 1, 2013.

While the 340B program delivers the opportunity for substantial cost savings, eligible hospitals often find program eligibility and compliance difficult to navigate or maintain. NAVEOS® assists hospitals in reaching the disproportionate share adjustment percentage for 340B program eligibility and maintaining DSH percentage compliance.

For more information, visit the NAVEOS® website at http://www.naveosdata.com at or call 1-888-550-2708.

Charlene Mathis, NAVEOS, http://www.NaveosData.com, (888) 550-2708, [email protected]