Patient Access to Drugs in Shortage Act of 2012
The source supplies the latest action, but no lifecycle stage.
Latest action (30 Nov 2012): Referred to the Subcommittee on Health.
What this bill does
H.R. 6611, the Patient Access to Drugs in Shortage Act of 2012, aims to address drug shortages. The bill proposes changes to Medicare, Medicaid, and the 340B drug pricing program. Specifically, it would alter payment amounts for certain sterile injectable drugs that have three or fewer active manufacturers, effective from July 1, 2013, to January 1, 2020. It also includes provisions to exclude certain branded prescription drugs from an annual fee if they are on a drug shortage list.
The bill's provisions primarily affect Medicare beneficiaries receiving sterile injectable drugs and impact drug manufacturers and covered entities participating in Medicare, Medicaid, and the 340B program. The legislation would also require the Secretary of Health and Human Services to study and report on the effects of these changes on patient access to sterile injectable products.
Introduced in the House of Representatives on November 29, 2012, H.R. 6611 was referred to committees. According to the provided information, this bill was introduced in a previous session of Congress and did not receive a vote. Its current status is "Introduced," indicating it has not advanced further in the legislative process.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official 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.
Timeline
30 Nov 2012
Referred to the Subcommittee on Health.
Common questions
- What does H.R. 6611 do?
- H.R. 6611, the Patient Access to Drugs in Shortage Act of 2012, aims to address drug shortages. The bill proposes changes to Medicare, Medicaid, and the 340B drug pricing program. Specifically, it would alter payment amounts for certain sterile injectable drugs that have three or fewer active manufacturers, effective from July 1, 2013, to January 1, 2020. It also includes provisions to exclude certain branded prescription drugs from an annual fee if they are on a drug shortage list. The bill's provisions primarily affect Medicare beneficiaries receiving sterile injectable drugs and impact drug manufacturers and covered entities participating in Medicare, Medicaid, and the 340B program. The legislation would also require the Secretary of Health and Human Services to study and report on the effects of these changes on patient access to sterile injectable products. Introduced in the House of Representatives on November 29, 2012, H.R. 6611 was referred to committees. According to the provided information, this bill was introduced in a previous session of Congress and did not receive a vote. Its current status is "Introduced," indicating it has not advanced further in the legislative process.
- Has H.R. 6611 become law?
- The source does not supply a confirmed lifecycle stage for H.R. 6611. Check the latest action and official source below.
- Who sponsored H.R. 6611?
- H.R. 6611 was sponsored by Rep. Cassidy, Bill [R-LA-6] (R-LA), with 4 cosponsors.
- What's the latest action on H.R. 6611?
- Referred to the Subcommittee on Health. (30 Nov 2012).
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