(i)#
Except as provided in subparagraphs (B) and (C)(iii), any State that provides for the purchase of foods under the program at retail grocery stores shall, with respect to the procurement of infant formula, use—
(I) a competitive bidding system; or
(II) any other cost containment measure that yields savings equal to or greater than savings generated by a competitive bidding system when such savings are determined by comparing the amounts of savings that would be provided over the full term of contracts offered in response to a single invitation to submit both competitive bids and bids for other cost containment systems for the sale of infant formula.
(i)(I)#
a competitive bidding system; or
(i)(II)#
any other cost containment measure that yields savings equal to or greater than savings generated by a competitive bidding system when such savings are determined by comparing the amounts of savings that would be provided over the full term of contracts offered in response to a single invitation to submit both competitive bids and bids for other cost containment systems for the sale of infant formula.
(ii)#
In determining whether a cost containment measure other than competitive bidding yields equal or greater savings, the State, in accordance with regulations issued by the Secretary, may take into account other cost factors (in addition to rebate levels and procedures for adjusting rebate levels when wholesale price levels change), such as—
(I) the number of infants who would not be expected to receive the primary contract infant formula under a competitive bidding system;
(II) the number of cans of infant formula for which no rebate would be provided under another rebate system; and
(III) differences in administrative costs relating to the implementation of the various cost containment systems (such as costs of converting a computer system for the purpose of operating a cost containment system and costs of preparing participants for conversion to a new or alternate cost containment system).
(ii)(I)#
the number of infants who would not be expected to receive the primary contract infant formula under a competitive bidding system;
(ii)(II)#
the number of cans of infant formula for which no rebate would be provided under another rebate system; and
(ii)(III)
(iii)Competitive bidding system .—#
A State agency using a competitive bidding system for infant formula shall award contracts to bidders offering the lowest net price for a specific infant formula for which manufacturers submit a bid unless the State agency demonstrates to the satisfaction of the Secretary that the weighted average retail price for different brands of infant formula in the State does not vary by more than 5 percent.
(iv)Size of state alliances.—#
(I) In general .— Except as provided in subclauses (II) through (IV), no State alliance may exist among States if the total number of infants served by States participating in the alliance as of October 1, 2003 , or such subsequent date determined by the Secretary for which data is available, would exceed 100,000.
(II) Addition of infant participants .— In the case of a State alliance that exists on June 30, 2004 , the alliance may continue and may expand to serve more than 100,000 infants but, except as provided in subclause (III), may not expand to include any additional State agency.
(III) Addition of small state agencies and indian state agencies .— Except as provided in paragraph (9)(B)(i)(II), any State alliance may expand to include any State agency that served less than 5,000 infant participants as of October 1, 2003 , or such subsequent date determined by the Secretary for which data is available, or any Indian State agency, if the State agency or Indian State agency requests to join the State alliance.
(IV) Secretarial waiver .— The Secretary may waive the requirements of this clause not earlier than 30 days after submitting to the Committee on Education and the Workforce of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a written report that describes the cost-containment and competitive benefits of the proposed waiver.
(iv)(I)In general .—#
Except as provided in subclauses (II) through (IV), no State alliance may exist among States if the total number of infants served by States participating in the alliance as of October 1, 2003 , or such subsequent date determined by the Secretary for which data is available, would exceed 100,000.
(ix)List of infant formula wholesalers, distributors, retailers, and manufacturers .—#
The State agency shall maintain a list of—
(I) infant formula wholesalers, distributors, and retailers licensed in the State in accordance with State law (including regulations); and
(II) infant formula manufacturers registered with the Food and Drug Administration that provide infant formula.
(ix)(I)#
infant formula wholesalers, distributors, and retailers licensed in the State in accordance with State law (including regulations); and
(ix)(II)#
infant formula manufacturers registered with the Food and Drug Administration that provide infant formula.
(v)First choice of issuance .—#
The State agency shall use the primary contract infant formula as the first choice of issuance (by formula type), with all other infant formulas issued as an alternative to the primary contract infant formula.
(vi)Rebate invoices .—#
Effective beginning October 1, 2004 , each State agency shall have a system to ensure that infant formula rebate invoices, under competitive bidding, provide a reasonable estimate or an actual count of the number of units sold to participants in the program under this section.
(vii)Separate solicitations .—#
In soliciting bids for infant formula under a competitive bidding system, any State agency, or State alliance, that served under the program a monthly average of more than 100,000 infants during the preceding 12-month period shall solicit bids from infant formula manufacturers under procedures that require that bids for rebates or discounts are solicited for milk-based and soy-based infant formula separately.
(viii)Cent-for-cent adjustments .—#
A bid solicitation for infant formula under the program shall require the manufacturer to adjust for price changes subsequent to the opening of the bidding process in a manner that requires—
(I) a cent-for-cent increase in the rebate amounts if there is an increase in the lowest national wholesale price for a full truckload of the particular infant formula; and
(II) a cent-for-cent decrease in the rebate amounts if there is a decrease in the lowest national wholesale price for a full truckload of the particular infant formula.
(viii)(I)#
a cent-for-cent increase in the rebate amounts if there is an increase in the lowest national wholesale price for a full truckload of the particular infant formula; and
(viii)(II)#
a cent-for-cent decrease in the rebate amounts if there is a decrease in the lowest national wholesale price for a full truckload of the particular infant formula.
(x)Purchase requirement .—#
A vendor authorized to participate in the program under this section shall only purchase infant formula from the list described in clause (ix).