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HR 6611 112th Congress House Health Government studies and investigations Health care costs and insurance Health care coverage and access Medicaid Medicare Prescription drugs User charges and fees

Patient Access to Drugs in Shortage Act of 2012

Introduced: November 29, 2012 Introduced by: Cassidy, Bill Republican · Louisiana See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Nov 30, 2012
Referred to the Subcommittee on Health.
Nov 29, 2012
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.
Nov 29, 2012
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now November 30, 2012

Referred to the Subcommittee on Health.

 Committees of jurisdiction 3