Patient
Access to Drugs in Shortage Act of 2012—Amends title XVIII (Medicare) of the
Social Security Act (SSA), with respect to use of average sales price payment
methodology for drugs and biologicals, to prescribe a formula for determining
the payment amount, using the volume-weighted wholesale acquisition cost, for a
multiple source or a single source sterile injectable drug product with three
or fewer active manufacturers, if there is no period of exclusivity in effect
or available.Incorporates such payment methodology under the hospital
outpatient department prospective payment system for any such drug furnished
between July 1, 2013, and January 1, 2020.Amends SSA title XIX (Medicaid) to
exempt from the rebate agreement requirement a multiple source drug furnished
between July 1, 2013, and January 1, 2020, and for which payment may be made
under Medicare part B (Supplementary Medicare Insurance).Amends the Public
Health Service Act to exclude such multiple source drugs from the term
"covered outpatient drug" subject to specified price limitations
under the "340B" drug pricing program.Directs the Secretary to
contract with an independent entity to study the effects of this Act on patient
access to sterile products.Amends the Patient Protection and Affordable Care
Act to exclude certain branded prescription drugs on a specified drug shortage
list from the annual fee imposed on branded prescription pharmaceutical
manufacturers and importers
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