Patient Access to Drugs in Shortage Act of 2012

Summary

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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3 official files

• Introduced in House (text)

  Introduced in House · EN · 29 November 2012

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• Introduced in House (PDF)

  Introduced in House · EN · 29 November 2012

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• Introduced in House

  summary · EN · 29 November 2012

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