HR 6611 · 112th Congress 2011–2013, ended

Patient Access to Drugs in Shortage Act of 2012

Fact sheet

Latest action · Nov 30, 2012 Referred to the Subcommittee on Health.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

  1. IntroducedNov 29, 2012
  2. Passed HouseNot reached
  3. Passed SenateNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

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.

Cosponsors 4

Members who signed on, in the order they did. All signed on Nov 29, 2012.

SeatCosponsorSigned on
R-MDAndy HarrisOriginalNov 29, 2012
R-MIDan BenishekOriginalNov 29, 2012
R-MIMike RogersOriginalNov 29, 2012
R-FLThomas J. RooneyOriginalNov 29, 2012

Actions 3

Everything that happened, newest first.

  1. Nov 30, 2012Referred to the Subcommittee on Health.
  2. Nov 29, 2012Introduced in House
  3. Nov 29, 2012Referred 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.

Subjects

Assigned by the Library of Congress. Policy area: Health.

Text 1

Each version as it was printed, newest first.

  1. Nov 29, 2012Introduced in House

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Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.