§ 1395w-3b. Competitive acquisition of outpatient drugs and biologicals
(a)
Implementation of competitive acquisition
(1)
Implementation of program
(A)
In general
The Secretary shall establish and implement a competitive acquisition program under which—
(i)
competitive acquisition areas are established for contract award purposes for acquisition of and payment for categories of competitively biddable drugs and biologicals (as defined in paragraph (2)) under this part;
(ii)
each physician is given the opportunity annually to elect to obtain drugs and biologicals under the program, rather than under section
1395w–3a of this title; and
(iii)
each physician who elects to obtain drugs and biologicals under the program makes an annual selection under paragraph (5) of the contractor through which drugs and biologicals within a category of drugs and biologicals will be acquired and delivered to the physician under this part.
This section shall not apply in the case of a physician who elects section
1395w–3a of this title to apply.
(B)
Implementation
For purposes of implementing the program, the Secretary shall establish categories of competitively biddable drugs and biologicals. The Secretary shall phase in the program with respect to those categories beginning in 2006 in such manner as the Secretary determines to be appropriate.
(C)
Waiver of certain provisions
In order to promote competition, in carrying out the program 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.
(2)
Competitively biddable drugs and biologicals and program defined
For purposes of this section—
(3)
Application of program payment methodology
(A)
In general
With respect to competitively biddable drugs and biologicals which are supplied under the program in an area and which are prescribed by a physician who has elected this section to apply—
(i)
the claim for such drugs and biologicals shall be submitted by the contractor that supplied the drugs and biologicals;
(B)
Process for adjustments
The Secretary shall provide a process for adjustments to payments in the case in which payment is made for drugs and biologicals which were billed at the time of dispensing but which were not actually administered.
(C)
Information for purposes of cost-sharing
The Secretary shall provide a process by which physicians submit information to contractors for purposes of the collection of any applicable deductible or coinsurance amounts under subparagraph (A)(ii).
(D)
Post-payment review process
The Secretary shall establish (by program instruction or otherwise) a post-payment review process (which may include the use of statistical sampling) to assure that payment is made for a drug or biological under this section only if the drug or biological has been administered to a beneficiary. The Secretary shall recoup, offset, or collect any overpayments determined by the Secretary under such process.
(4)
Contract required
Payment may not be made under this part for competitively biddable drugs and biologicals prescribed by a physician who has elected this section to apply within a category and a competitive acquisition area with respect to which the program applies unless—
(5)
Contractor selection process
(A)
Annual selection
(B)
Information on contractors
The Secretary shall make available to physicians on an ongoing basis, through a directory posted on the Internet website of the Centers for Medicare & Medicaid Services or otherwise and upon request, a list of the contractors under this section in the different competitive acquisition areas.
(C)
Selecting physician defined
For purposes of this section, the term “selecting physician” means, with respect to a contractor and category and competitive acquisition area, a physician who has elected this section to apply and has selected to apply under this section such contractor for such category and area.
(b)
Program requirements
(1)
Contract for competitively biddable drugs and biologicals
The Secretary shall conduct a competition among entities for the acquisition of competitively biddable drugs and biologicals. Notwithstanding any other provision of this subchapter, in the case of a multiple source drug, the Secretary shall conduct such competition among entities for the acquisition of at least one competitively biddable drug and biological within each billing and payment code within each category for each competitive acquisition area.
(2)
Conditions for awarding contract
(A)
In general
The Secretary may not award a contract to any entity under the competition conducted in a competitive acquisition area pursuant to paragraph (1) with respect to the acquisition of competitively biddable drugs and biologicals within a category unless the Secretary finds that the entity meets all of the following with respect to the contract period involved:
(i)
Capacity to supply competitively biddable drug or biological within category
(I)
In general
The entity has sufficient arrangements to acquire and to deliver competitively biddable drugs and biologicals within such category in the area specified in the contract.
(II)
Shipment methodology
The entity has arrangements in effect for the shipment at least 5 days each week of competitively biddable drugs and biologicals under the contract and for the timely delivery (including for emergency situations) of such drugs and biologicals in the area under the contract.
(ii)
Quality, service, financial performance and solvency standards
The entity meets quality, service, financial performance, and solvency standards specified by the Secretary, including—
(B)
Additional considerations
The Secretary may refuse to award a contract under this section, and may terminate such a contract, with an entity based upon—
(i)
the suspension or revocation, by the Federal Government or a State government, of the entity’s license for the distribution of drugs or biologicals (including controlled substances); or
(ii)
the exclusion of the entity under section
1320a–7 of this title from participation under this subchapter.
(3)
Awarding multiple contracts for a category and area
The Secretary may limit (but not below 2) the number of qualified entities that are awarded such contracts for any category and area. The Secretary shall select among qualified entities based on the following:
(4)
Terms of contracts
(A)
In general
A contract entered into with an entity under the competition conducted pursuant to paragraph (1) is subject to terms and conditions that the Secretary may specify consistent with this section.
(B)
Period of contracts
A contract under this section shall be for a term of 3 years, but may be terminated by the Secretary or the entity with appropriate, advance notice.
(C)
Integrity of drug and biological distribution system
A contractor (as defined in subsection (a)(2)(D) of this section) shall—
(i)
acquire all drug and biological products it distributes directly from the manufacturer or from a distributor that has acquired the products directly from the manufacturer; and
(D)
Compliance with code of conduct and fraud and abuse rules
Under the contract—
(E)
Direct delivery of drugs and biologicals to physicians
Under the contract the contractor shall only supply competitively biddable drugs and biologicals directly to the selecting physicians and not directly to individuals, except under circumstances and settings where an individual currently receives a drug or biological in the individual’s home or other non-physician office setting as the Secretary may provide. The contractor shall not deliver drugs and biologicals to a selecting physician except upon receipt of a prescription for such drugs and biologicals, and such necessary data as may be required by the Secretary to carry out this section. This section does not—
(5)
Permitting access to drugs and biologicals
The Secretary shall establish rules under this section under which drugs and biologicals which are acquired through a contractor under this section may be used to resupply inventories of such drugs and biologicals which are administered consistent with safe drug practices and with adequate safeguards against fraud and abuse. The previous sentence shall apply if the physicians can demonstrate to the Secretary all of the following:
(c)
Bidding process
(1)
In general
In awarding a contract for a category of drugs and biologicals in an area under the program, the Secretary shall consider with respect to each entity seeking to be awarded a contract the bid price and the other factors referred to in subsection (b)(3) of this section.
(2)
Bid defined
In this section, the term “bid” means an offer to furnish a competitively biddable drug or biological for a particular price and time period.
(3)
Bidding on a national or regional basis
Nothing in this section shall be construed as precluding a bidder from bidding for contracts in all areas of the United States or as requiring a bidder to submit a bid for all areas of the United States.
(4)
Uniformity of bids within area
The amount of the bid submitted under a contract offer for any competitively biddable drug or biological for an area shall be the same for that drug or biological for all portions of that area.
(5)
Confidentiality of bids
The provisions of subparagraph (D) of section
1396r–8
(b)(3) of this title shall apply to periods during which a bid is submitted with respect to a competitively biddable drug or biological under this section in the same manner as it applies to information disclosed under such section, except that any reference—
(A)
in that subparagraph to a “manufacturer or wholesaler” is deemed a reference to a “bidder” under this section;
(6)
Inclusion of costs
The bid price submitted in a contract offer for a competitively biddable drug or biological shall—
(d)
Computation of payment amounts
(1)
In general
Payment under this section for competitively biddable drugs or biologicals shall be based on bids submitted and accepted under this section for such drugs or biologicals in an area. Based on such bids the Secretary shall determine a single payment amount for each competitively biddable drug or biological in the area.
(2)
Special rules
The Secretary shall establish rules regarding the use under this section of the alternative payment amount provided under section
1395w–3a of this title to the use of a price for specific competitively biddable drugs and biologicals in the following cases:
(e)
Cost-sharing
(1)
Application of coinsurance
Payment under this section for competitively biddable drugs and biologicals shall be in an amount equal to 80 percent of the payment basis described in subsection (d)(1) of this section.
(3)
Collection
Such coinsurance and deductible shall be collected by the contractor that supplies the drug or biological involved. Subject to subsection (a)(3)(B) of this section, such coinsurance and deductible may be collected in a manner similar to the manner in which the coinsurance and deductible are collected for durable medical equipment under this part.
(f)
Special payment rules
(1)
Use in exclusion cases
If the Secretary excludes a drug or biological (or class of drugs or biologicals) under subsection (a)(1)(D) of this section, the Secretary may provide for payment to be made under this part for such drugs and biologicals (or class) using the payment methodology under section
1395w–3a of this title.
(3)
Protection for beneficiary in case of medical necessity denial
For protection of individuals against liability in the case of medical necessity determinations, see section
1395u
(b)(3)(B)(ii)(III) of this title.
(g)
Judicial review
There shall be no administrative or judicial review under section
1395ff of this title, section
1395oo of this title, or otherwise, of—
[1] See References in Text note below.