covered document

(1) Implementation of programs (A) In general The Secretary shall establish and implement programs under which competitive acquisition areas are established throughout the United States for contract award purposes for the furnishing under this part of competitively priced items and services (described in paragraph (2)) for which payment is made under this part. Such areas may differ for different items and services. (B) Phased-in implementation The programs— (i) shall be phased in among competitive acquisition areas in a manner consistent with subparagraph (D) so that the competition under the programs occurs in— (I) 10 of the largest metropolitan statistical areas in 2007; (II) an additional 91 of the largest metropolitan statistical areas in 2011; and (III) additional areas after 2011 (or, in the case of national mail order for items and services, after 2010); and (ii) may be phased in first among the highest cost and highest volume items and services or those items and services that the Secretary determines have the largest savings potential. (C) Waiver of certain provisions In carrying out the programs, the Secretary may waive such provisions of the Federal Acquisition Regulation as are necessary for the efficient implementation of this section, other than provisions relating to confidentiality of information and such other provisions as the Secretary determines appropriate. (D) Changes in competitive acquisition programs (i) Round 1 of competitive acquisition program Notwithstanding subparagraph (B)(i)(I) and in implementing the first round of the competitive acquisition programs under this section— (I) the contracts awarded under this section before July 15, 2008 , are terminated, no payment shall be made under this subchapter on or after July 15, 2008 , based on such a contract, and, to the extent that any damages may be applicable as a result of the termination of such contracts, such damages shall be payable from the Federal Supplementary Medical Insurance Trust Fund under section 1395t of this title ; (II) the Secretary shall conduct the competition for such round in a manner so that it occurs in 2009 with respect to the same items and services and the same areas, except as provided in subclauses (III) and (IV); (III) the Secretary shall exclude Puerto Rico so that such round of competition covers 9, instead of 10, of the largest metropolitan statistical areas; and (IV) there shall be excluded negative pressure wound therapy items and services. Nothing in subclause (I) shall be construed to provide an independent cause of action or right to administrative or judicial review with regard to the termination provided under such subclause. (ii) Round 2 of competitive acquisition program In implementing the second round of the competitive acquisition programs under this section described in subparagraph (B)(i)(II)— (I) the metropolitan statistical areas to be included shall be those metropolitan statistical areas selected by the Secretary for such round as of June 1, 2008 ; (II) the Secretary shall include the next 21 largest metropolitan statistical areas by total population (after those selected under subclause (I)) for such round; and (III) the Secretary may subdivide metropolitan statistical areas with populations (based upon the most recent data from the Census Bureau) of at least 8,000,000 into separate areas for competitive acquisition purposes. (iii) Exclusion of certain areas in subsequent rounds of competitive acquisition programs In implementing subsequent rounds of the competitive acquisition programs under this section, including under subparagraph (B)(i)(III), for competitions occurring before 2015, the Secretary shall exempt from the competitive acquisition program (other than national mail order) the following: (I) Rural areas. (II) Metropolitan statistical areas not selected under round 1 or round 2 with a population of less than 250,000. (III) Areas with a low population density within a metropolitan statistical area that is otherwise selected, as determined for purposes of paragraph (3)(A). (E) Verification by OIG The Inspector General of the Department of Health and Human Services shall, through post-award audit, survey, or otherwise, assess the process used by the Centers for Medicare & Medicaid Services to conduct competitive bidding and subsequent pricing determinations under this section that are the basis for pivotal bid amounts and single payment amounts for items and services in competitive bidding areas under rounds 1 and 2 of the competitive acquisition programs under this section and may continue to verify such calculations for subsequent rounds of such programs. (F) Supplier feedback on missing financial documentation (i) In general In the case of a bid where one or more covered documents in connection with such bid have been submitted not later than the covered document review date specified in clause (ii), the Secretary— (I) shall provide, by not later than 45 days (in the case of the first round of the competitive acquisition programs as described in subparagraph (B)(i)(I)) or 90 days (in the case of a subsequent round of such programs) after the covered document review date, for notice to the bidder of all such documents that are missing as of the covered document review date; and (II) may not reject the bid on the basis that any covered document is missing or has not been submitted on a timely basis, if all such missing documents identified in the notice provided to the bidder under subclause (I) are submitted to the Secretary not later than 10 business days after the date of such notice. (ii) Covered document review date The covered document review date specified in this clause with respect to a competitive acquisition program is the later of— (I) the date that is 30 days before the final date specified by the Secretary for submission of bids under such program; or (II) the date that is 30 days after the first date specified by the Secretary for submission of bids under such program. (iii) Limitations of process The process provided under this subparagraph— (I) applies only to the timely submission of covered documents; (II) does not apply to any determination as to the accuracy or completeness of covered documents submitted or whether such documents meet applicable requirements; (III) shall not prevent the Secretary from rejecting a bid based on any basis not described in clause (i)(II); and (IV) shall not be construed as permitting a bidder to change bidding amounts or to make other changes in a bid submission. (iv) Covered document defined In this subparagraph, the term “covered document” means a financial, tax, or other document required to be submitted by a bidder as part of an original bid submission under a competitive acquisition program in order to meet required financial standards. Such term does not include other documents, such as the bid itself or accreditation documentation. (G) Requiring bid bonds for bidding entities With respect to rounds of competitions beginning under this subsection for contracts beginning not earlier than January 1, 2017 , and not later than January 1, 2019 , an entity may not submit a bid for a competitive acquisition area unless, as of the deadline for bid submission, the entity has obtained (and provided the Secretary with proof of having obtained) a bid surety bond (in this paragraph referred to as a “bid bond”) in a form specified by the Secretary consistent with subparagraph (H) and in an amount that is not less than $50,000 and not more than $100,000 for each competitive acquisition area in which the entity submits the bid. (H) Treatment of bid bonds submitted (i) For bidders that submit bids at or below the median and are offered but do not accept the contract In the case of a bidding entity that is offered a contract for any product category for a competitive acquisition area, if— (I) the entity’s composite bid for such product category and area was at or below the median composite bid rate for all bidding entities included in the calculation of the single payment amounts for such product category and area; and (II) the entity does not accept the contract offered for such product category and area, the bid bond submitted by such entity for such area shall be forfeited by the entity and the Secretary shall collect on it. (ii) Treatment of other bidders In the case of a bidding entity for any product category for a competitive acquisition area, if the entity does not meet the bid forfeiture conditions in subclauses (I) and (II) of clause (i) for any product category for such area, the bid bond submitted by such entity for such area shall be returned within 90 days of the public announcement of the contract suppliers for such area.


42 USC § 1395w-3(a)(1)

Scoping language

In this subparagraph
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