(a) Requirement to submit a bid. Except as provided under Sec. 414.404(b), in order for a supplier to receive payment for items furnished to beneficiaries under a competitive bidding program, the supplier must submit a bid to furnish those items and be awarded a contract under this subpart.
(b) Grouping of items into product categories. (1) Bids are submitted for items grouped into product categories.
(1) Bids are submitted for items grouped into product categories.
(2) The bids submitted for each item or drug in a product category cannot exceed the payment amount that would otherwise apply to the item under subpart C, subpart D, or subpart I of this part.
(3) The bids submitted for standard power wheelchairs paid in accordance with the special payment rules at Sec. 414.409(a) cannot exceed the average monthly payment for the bundle of items and services that would otherwise apply to the item under subpart D of this part.
(4) The bids submitted for continuous positive airway pressure (CPAP) devices paid in accordance with the special payment rules at Sec. 414.409(a) cannot exceed the 1993 fee schedule amounts for these items, increased by the covered item update factors provided for these items in section 1834(a)(14) of the Act.
(5) Suppliers shall take into consideration the special payment rules at Sec. 414.409(d) when submitting bids for furnishing power wheelchairs under competitions where these rules apply.
(c) Furnishing of items. A bid must include all costs related to furnishing an item, including all services directly related to the furnishing of the item.
(d) Separate bids. For each product category that a supplier is seeking to furnish under a competitive bidding program, the supplier must submit a separate bid for each item in that product category.
(e) Commonly-owned or controlled suppliers. (1) For purposes of this paragraph--
(1) For purposes of this paragraph--
(i) An ownership interest is the possession of equity in the capital, stock or profits of another supplier;
(ii) A controlling interest exists if one or more of owners of a supplier is an officer, director or partner in another supplier; and
(iii) Two or more suppliers are commonly-owned if one or more of them has an ownership interest totaling at least 5 percent in the other(s).
(2) A supplier must disclose in its bid each supplier in which it has an ownership or controlling interest and each supplier which has an ownership or controlling interest in it.
(3) Commonly-owned or controlled suppliers must submit a single bid to furnish a product category in a CBA. Each commonly-owned or controlled supplier that is located in the CBA for which the bid is being submitted must be included in the bid. The bid must also include any commonly-owned or controlled supplier that is located outside of the CBA but would furnish the product category to the beneficiaries who maintain a permanent residence in the CBA.
(f) Mail order suppliers. (1) Suppliers that furnish items through the mail must submit a bid to furnish these items in a CBA in which a mail order competitive bidding program that includes the items is implemented.
(1) Suppliers that furnish items through the mail must submit a bid to furnish these items in a CBA in which a mail order competitive bidding program that includes the items is implemented.
(2) Suppliers that submit one or more bids under paragraph (f)(1) of this section may submit the same bid amount for each item under each competitive bidding program for which it submits a bid.
(g) Applicability of the mail order competitive bidding program. Suppliers that do not furnish items through the mail are not required to participate in a nationwide or regional mail order competitive bidding program that includes the same items. Suppliers may continue to furnish these items in--
(1) A CBA, if the supplier is awarded a contract under this subpart; or
(2) An area not designated as a CBA. [72 FR 18085, Apr. 10, 2007, as amended at 79 FR 66264, Nov. 6, 2014]