Source: http://www4.law.cornell.edu/uscode/text/42/1395w-3?quicktabs_8=4
Timestamp: 2013-12-11 06:41:21
Document Index: 432493344

Matched Legal Cases: ['§ 1395', '§ 1395', '§ 1395', '§\u2009145', '§ 1847', '§ 4319', '§ 1000', '§ 321', '§ 302', '§ 145', '§ 6410', '§ 301', '§ 1847', '§ 202', '§ 608', '§ 201', '§ 6410', '§ 6410', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 145', '§ 154', '§ 321', '§ 302', '§ 154', '§ 302', '§ 154', 'art 406', 'art 414']

42 USC § 1395w–3 - Competitive acquisition of certain items and services | Title 42 - The Public Health and Welfare | U.S. Code | LII / Legal Information Institute
USC › Title 42 › Chapter 7 › Subchapter XVIII › Part B › § 1395w–3	prevnext
42 USC § 1395w–3 - Competitive acquisition of certain items and services
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.
Supplier feedback on missing financial documentation (i)
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—
Covered document review date
The covered document review date specified in this clause with respect to a competitive acquisition program is the later of—
The process provided under this subparagraph—
Covered document defined
Items and services described The items and services referred to in paragraph (1) are the following:
Durable medical equipment and medical supplies Covered items (as defined in section 1395m
(a)(13) of this title) for which payment would otherwise be made under section 1395m
(a) of this title, including items used in infusion and drugs (other than inhalation drugs) and supplies used in conjunction with durable medical equipment, but excluding class III devices under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and excluding certain complex rehabilitative power wheelchairs recognized by the Secretary as classified within group 3 or higher (and related accessories when furnished in connection with such wheelchairs).
Other equipment and supplies Items and services described in section 1395u
(s)(2)(D) of this title, other than parenteral nutrients, equipment, and supplies.
Off-the-shelf orthotics Orthotics described in section 1395x
(s)(9) of this title for which payment would otherwise be made under section 1395m
(h) of this title which require minimal self-adjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit to the individual.
Exception authority In carrying out the programs under this section, the Secretary may exempt—
Special rule for certain rented items of durable medical equipment and oxygen In the case of a covered item for which payment is made on a rental basis under section 1395m
(a) of this title and in the case of payment for oxygen under section 1395m
(a)(5) of this title, the Secretary shall establish a process by which rental agreements for the covered items and supply arrangements with oxygen suppliers entered into before the application of the competitive acquisition program under this section for the item may be continued notwithstanding this section. In the case of any such continuation, the supplier involved shall provide for appropriate servicing and replacement, as required under section 1395m
Physician authorization (A)
In general With respect to items or services included within a particular HCPCS code, the Secretary may establish a process for certain items and services under which a physician may prescribe a particular brand or mode of delivery of an item or service within such code if the physician determines that use of the particular item or service would avoid an adverse medical outcome on the individual, as determined by the Secretary.
No effect on payment amount A prescription under subparagraph (A) shall not affect the amount of payment otherwise applicable for the item or service under the code involved.
Application For each competitive acquisition area in which the program is implemented under this subsection with respect to items and services, the payment basis determined under the competition conducted under subsection (b) of this section shall be substituted for the payment basis otherwise applied under section 1395m
(a) of this title, section 1395m
(h) of this title, or section 1395u
(s) of this title, as appropriate.
Exemption from competitive acquisition The programs under this section shall not apply to the following:
Certain off-the-shelf orthotics Items and services described in paragraph (2)(C) if furnished—
Certain durable medical equipment Those items and services described in paragraph (2)(A)—
In general The Secretary shall conduct a competition among entities supplying items and services described in subsection (a)(2) of this section for each competitive acquisition area in which the program is implemented under subsection (a) of this section with respect to such items and services.
Conditions for awarding contract (A)
In general The Secretary may not award a contract to any entity under the competition conducted in an [1]
competitive acquisition area pursuant to paragraph (1) to furnish such items or services unless the Secretary finds all of the following:
The entity meets applicable quality standards specified by the Secretary under section 1395m
Timely implementation of program Any delay in the implementation of quality standards under section 1395m
(a)(20) of this title or delay in the receipt of advice from the program oversight committee established under subsection (c) of this section shall not delay the implementation of the competitive acquisition program under this section.
Contents of contract (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.
Term of contracts The Secretary shall recompete contracts under this section not less often than once every 3 years.
Disclosure of subcontractors (i)
Not later than 10 days after the date a supplier enters into a contract with the Secretary under this section, such supplier shall disclose to the Secretary, in a form and manner specified by the Secretary, the information on—
whether each such subcontractor meets the requirement of section 1395m
(a)(20)(F)(i) of this title, if applicable to such subcontractor.
Limit on number of contractors (A)
In general The Secretary may limit the number of contractors in a competitive acquisition area to the number needed to meet projected demand for items and services covered under the contracts. In awarding contracts, the Secretary shall take into account the ability of bidding entities to furnish items or services in sufficient quantities to meet the anticipated needs of individuals for such items or services in the geographic area covered under the contract on a timely basis.
Multiple winners The Secretary shall award contracts to multiple entities submitting bids in each area for an item or service.
In general Payment under this part for competitively priced items and services described in subsection (a)(2) of this section shall be based on bids submitted and accepted under this section for such items and services. Based on such bids the Secretary shall determine a single payment amount for each item or service in each competitive acquisition area.
Reduced beneficiary cost-sharing (i)
Application of coinsurance
Application of deductible
Before applying clause (i), the individual shall be required to meet the deductible described in section 1395l
Payment on assignment-related basis Payment for any item or service furnished by the entity may only be made under this section on an assignment-related basis.
Construction Nothing in this section shall be construed as precluding the use of an advanced beneficiary notice with respect to a competitively priced item and service.
Participating contractors (A)
In general Except as provided in subsection (a)(4) of this section, payment shall not be made for items and services described in subsection (a)(2) of this section furnished by a contractor and for which competition is conducted under this section unless—
Bid defined In this section, the term “bid” means an offer to furnish an item or service for a particular price and time period that includes, where appropriate, any services that are attendant to the furnishing of the item or service.
Rules for mergers and acquisitions In applying subparagraph (A) to a contractor, the contractor shall include a successor entity in the case of a merger or acquisition, if the successor entity assumes such contract along with any liabilities that may have occurred thereunder.
Protection of small suppliers In developing procedures relating to bids and the awarding of contracts under this section, the Secretary shall take appropriate steps to ensure that small suppliers of items and services have an opportunity to be considered for participation in the program under this section.
Consideration in determining categories for bids The Secretary may consider the clinical efficiency and value of specific items within codes, including whether some items have a greater therapeutic advantage to individuals.
Authority to contract for education, monitoring, outreach, and complaint services The Secretary may enter into contracts with appropriate entities to address complaints from individuals who receive items and services from an entity with a contract under this section and to conduct appropriate education of and outreach to such individuals and monitoring quality of services with respect to the program.
Authority to contract for implementation The Secretary may contract with appropriate entities to implement the competitive bidding program under this section.
Special rule in case of competition for diabetic testing strips (A)
In general With respect to the competitive acquisition program for diabetic testing strips conducted after the first round of the competitive acquisition programs, if an entity does not demonstrate to the Secretary that its bid covers types of diabetic testing strip products that, in the aggregate and taking into account volume for the different products, cover 50 percent (or such higher percentage as the Secretary may specify) of all such types of products, the Secretary shall reject such bid. The volume for such types of products may be determined in accordance with such data (which may be market based data) as the Secretary recognizes.
Study of types of testing strip products Before 2011, the Inspector General of the Department of Health and Human Services shall conduct a study to determine the types of diabetic testing strip products by volume that could be used to make determinations pursuant to subparagraph (A) for the first competition under the competitive acquisition program described in such subparagraph and submit to the Secretary a report on the results of the study. The Inspector General shall also conduct such a study and submit such a report before the Secretary conducts a subsequent competitive acquistion [2]
program described in subparagraph (A).
No administrative or judicial review There shall be no administrative or judicial review under section 1395ff of this title, section 1395oo of this title, or otherwise, of—
the selection of items and services for competitive acquisition under subsection (a)(2) of this section;
Program Advisory and Oversight Committee (1)
Establishment The Secretary shall establish a Program Advisory and Oversight Committee (hereinafter in this section referred to as the “Committee”).
Membership; terms The Committee shall consist of such members as the Secretary may appoint who shall serve for such term as the Secretary may specify.
Advice The Committee shall provide advice to the Secretary with respect to the following functions:
The establishment of financial standards for purposes of subsection (b)(2)(A)(ii) of this section.
The development of proposals for efficient interaction among manufacturers, providers of services, suppliers (as defined in section 1395x
(d) of this title), and individuals.
The establishment of quality standards under section 1395m
Additional duties The Committee shall perform such additional functions to assist the Secretary in carrying out this section as the Secretary may specify.
Inapplicability of FACA The provisions of the Federal Advisory Committee Act (5 U.S.C. App.) shall not apply.
Termination The Committee shall terminate on December 31, 2011.
Report Not later than July 1, 2011, the Secretary shall submit to Congress a report on the programs under this section. The report shall include information on savings, reductions in cost-sharing, access to and quality of items and services, and satisfaction of individuals.
Repealed. Pub. L. 110–275, title I, § 145(a)(1),July 15, 2008, 122 Stat. 2547 (f)
Competitive acquisition ombudsman The Secretary shall provide for a competitive acquisition ombudsman within the Centers for Medicare & Medicaid Services in order to respond to complaints and inquiries made by suppliers and individuals relating to the application of the competitive acquisition program under this section. The ombudsman may be within the office of the Medicare Beneficiary Ombudsman appointed under section 1395b–9
(c) of this title. The ombudsman shall submit to Congress an annual report on the activities under this subsection, which report shall be coordinated with the report provided under section 1395b–9
So in original. Probably should be “acquisition”.
(Aug. 14, 1935, ch. 531, title XVIII, § 1847, as added Pub. L. 105–33, title IV, § 4319(a),Aug. 5, 1997, 111 Stat. 392; amended Pub. L. 106–113, div. B, § 1000(a)(6) [title III, § 321(c)], Nov. 29, 1999, 113 Stat. 1536, 1501A–366; Pub. L. 108–173, title III, § 302(b)(1),Dec. 8, 2003, 117 Stat. 2224; Pub. L. 110–275, title I, §§ 145(a)(1), 154(a)(1), (b)(2), (3), (c)(2)(A), (B), (d)(1), (3), (4),July 15, 2008, 122 Stat. 2547, 2560, 2565–2568; Pub. L. 111–148, title VI, § 6410(a),Mar. 23, 2010, 124 Stat. 773.)
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a)(2)(A), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.
A prior section 1395w–3, act Aug. 14, 1935, ch. 531, title XVIII, § 1847, as added July 1, 1988, Pub. L. 100–360, title II, § 202(j), 102 Stat. 719; amended Oct. 13, 1988, Pub. L. 100–485, title VI, § 608(d)(5)(I), 102 Stat. 2414, provided for appointment of Prescription Drug Payment Review Commission by Director of Congressional Office of Technology Assessment, prior to repeal by Pub. L. 101–234, title II, § 201(a), (c),Dec. 13, 1989, 103 Stat. 1981, effective Jan. 1, 1990.
2010—Subsec. (a)(1)(B)(i)(II). Pub. L. 111–148, § 6410(a)(1), substituted “91” for “70”.
Subsec. (a)(1)(D)(ii)(II), (III). Pub. L. 111–148, § 6410(a)(2), added subcl. (II) and redesignated former subcl. (II) as (III).
2008—Subsec. (a)(1)(B)(i). Pub. L. 110–275, § 154(a)(1)(A)(i), inserted “consistent with subparagraph (D)” after “in a manner” in introductory provisions.
Subsec. (a)(1)(B)(i)(II). Pub. L. 110–275, § 154(a)(1)(A)(ii), substituted “an additional 70” for “80” and “in 2011” for “in 2009”.
Subsec. (a)(1)(B)(i)(III). Pub. L. 110–275, § 154(a)(1)(A)(iii), substituted “after 2011 (or, in the case of national mail order for items and services, after 2010)” for “after 2009”.
Subsec. (a)(1)(D) to (F). Pub. L. 110–275, § 154(a)(1)(A)(iv), added subpars. (D) to (F).
Subsec. (a)(2)(A). Pub. L. 110–275, § 154(a)(1)(B), which directed amendment of par. (2)(A) of subsec. (a)(1) by inserting “and excluding certain complex rehabilitative power wheelchairs recognized by the Secretary as classified within group 3 or higher (and related accessories when furnished in connection with such wheelchairs)” before period at end, was executed by making the insertion in subsec. (a)(2)(A), to reflect the probable intent of Congress.
Subsec. (a)(7). Pub. L. 110–275, § 154(d)(1), added par. (7).
Subsec. (b)(3)(C). Pub. L. 110–275, § 154(b)(2), added subpar. (C).
Subsec. (b)(10). Pub. L. 110–275, § 154(d)(3)(B), added par. (10). Former par. (10) redesignated (11).
Subsec. (b)(11). Pub. L. 110–275, § 154(d)(3)(A), redesignated par. (10) as (11).
Subsec. (b)(11)(C). Pub. L. 110–275, § 154(d)(4)(A), inserted “and the identification of areas under subsection (a)(1)(D)(iii)” after “(a)(1)(A)”.
Subsec. (b)(11)(D). Pub. L. 110–275, § 154(d)(4)(B), inserted “and implementation of subsection (a)(1)(D)” after “(a)(1)(B)”.
Subsec. (b)(11)(G). Pub. L. 110–275, § 154(d)(4)(C)–(E), added subpar. (G).
Subsec. (c)(5). Pub. L. 110–275, § 154(c)(2)(A), substituted “December 31, 2011” for “December 31, 2009”.
Subsec. (d). Pub. L. 110–275, § 154(c)(2)(B), substituted “July 1, 2011” for “July 1, 2009”.
Subsec. (e). Pub. L. 110–275, § 145(a)(1), struck out subsec. (e) which related to a demonstration project on the application of competitive acquisition to clinical diagnostic laboratory tests, terms and conditions of the project, and reporting requirement.
Subsec. (f). Pub. L. 110–275, § 154(b)(3), added subsec. (f).
2003—Pub. L. 108–173amended section catchline and text generally, substituting provisions relating to competitive acquisition of certain items and services for provisions relating to demonstration projects for competitive acquisition of items and services.
1999—Subsec. (b)(2). Pub. L. 106–113inserted “and” after “specified by the Secretary”.
Amendment by section 154 ofPub. L. 110–275effective June 30, 2008, see section 154(e) ofPub. L. 110–275, set out as a note under section 1395m of this title.
Amendment by Pub. L. 106–113effective as if included in the enactment of the Balanced Budget Act of 1997, Pub. L. 105–33, except as otherwise provided, see section 1000(a)(6) [title III, § 321(m)] of Pub. L. 106–113, set out as a note under section 1395d of this title.
Pub. L. 108–173, title III, § 302(b)(3),Dec. 8, 2003, 117 Stat. 2230, as amended by Pub. L. 110–275, title I, § 154(c)(1),July 15, 2008, 122 Stat. 2565, provided that:
“(A) Study.—The Comptroller General of the United States shall conduct a study on the impact of competitive acquisition of durable medical equipment under section 1847 of the Social Security Act [this section], as amended by paragraph (1) and as amended by section 2 of the Medicare DMEPOS Competitive Acquisition Reform Act of 2008 [probably should refer to section 154 of the Medicare Improvements for Patients and Providers Act of 2008, Pub. L. 110–275], on suppliers and manufacturers of such equipment and on patients. Such study shall specifically examine the impact of such competitive acquisition on access to, and quality of, such equipment and service related to such equipment and the topics specified in subparagraph (C).
“(B) Report.—Not later than 1 year after the first date that payments are made under section 1847 of the Social Security Act, the Comptroller General shall submit to Congress a report on the study conducted under subparagraph (A) and shall include in the report such recommendations as the Comptroller General determines appropriate.
“(C) Topics.—The topics specified in this subparagraph, for the study under subparagraph (A) concerning the competitive acquisition program, are the following:
“(i) Beneficiary access to items and services under the program, including the impact on such access of awarding contracts to bidders that—
“(I) did not have a physical presence in an area where they received a contract; or
“(II) had no previous experience providing the product category they were contracted to provide.
“(ii) Beneficiary satisfaction with the program and cost savings to beneficiaries under the program.
“(iii) Costs to suppliers of participating in the program and recommendations about ways to reduce those costs without compromising quality standards or savings to the Medicare program.
“(iv) Impact of the program on small business suppliers.
“(v) Analysis of the impact on utilization of different items and services paid within the same Healthcare Common Procedure Coding System (HCPCS) code.
“(vi) Costs to the Centers for Medicare & Medicaid Services, including payments made to contractors, for administering the program compared with administration of a fee schedule, in comparison with the relative savings of the program.
“(vii) Impact on access, Medicare spending, and beneficiary spending of any difference in treatment for diabetic testing supplies depending on how such supplies are furnished.
“(viii) Such other topics as the Comptroller General determines to be appropriate.”
Pub. L. 108–173, title III, § 302(e),Dec. 8, 2003, 117 Stat. 2233, as amended by Pub. L. 110–275, title I, § 154(c)(2)(C),July 15, 2008, 122 Stat. 2566, provided that: “The Inspector General of the Department of Health and Human Services shall conduct a study to determine the extent to which (if any) suppliers of covered items of durable medical equipment that are subject to the competitive acquisition program under section 1847 of the Social Security Act [this section], as amended by subsection (a) [probably should be (b)(1)], are soliciting physicians to prescribe certain brands or modes of delivery of covered items based on profitability. Not later than July 1, 2011, the Inspector General shall submit to Congress a report on such study.”
Section 4319(c) ofPub. L. 105–33provided that: “The Comptroller of the United States shall study the effectiveness of the establishment of competitive acquisition areas under section 1847(a) of the Social Security Act [subsec. (a) of this section], as added by this section.”
This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.42 CFR - Title 42—Public Health42 CFR Part 406 - HOSPITAL INSURANCE ELIGIBILITY AND ENTITLEMENT42 CFR Part 414 - PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES