US Congress House Bill 6611 (Prior Session Legislation)

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Spectrum: Partisan Bill (Republican 5-0)
Status: Introduced on November 29 2012 - 25% progression, died in committee
Action: 2012-11-30 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

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.

Patient Access to Drugs in Shortage Act of 2012

Sen. Bill Cassidy [R-LA]	Rep. Dan Benishek [R-MI]	Rep. Andy Harris [R-MD]	Rep. Mike J. Rogers [R-MI]
Rep. Thomas Rooney [R-FL]

Date	Chamber	Action
2012-11-30	House	Referred to the Subcommittee on Health.
2012-11-29	House	Referred to House Ways and Means
2012-11-29	House	Referred to House Energy and Commerce
2012-11-29	House	Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Type	Source
Summary	https://www.congress.gov/bill/112th-congress/house-bill/6611/all-info
Text	https://www.congress.gov/112/bills/hr6611/BILLS-112hr6611ih.pdf