 So in original. Probably should be “a”.

competitive acquisition area pursuant to paragraph (1) to furnish such items or services unless the Secretary finds all of the following:

 So in original. Probably should be “acquisition”.

program described in subparagraph (A).

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a)(2)(A), is act June 25, 1938, ch. 675, 52 Stat. 1040, 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.

Prior Provisions

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.

Amendments

2022—Subsec. (a)(2)(D). Pub. L. 117–328 added subpar. (D).

Subsec. (c)(4). Pub. L. 117–286 substituted “chapter 10 of title 5” for “FACA” in heading and “chapter 10 of title 5” for “the Federal Advisory Committee Act (5 U.S.C. App.)” in text.

2019—Subsec. (a)(2)(A). Pub. L. 116–94 inserted “, complex rehabilitative manual wheelchairs (as determined by the Secretary), and certain manual wheelchairs (identified, as of October 1, 2018, by HCPCS codes E1235, E1236, E1237, E1238, and K0008 or any successor to such codes)” after “group 3 or higher” and substituted “such complex rehabilitative power wheelchairs, complex rehabilitative manual wheelchairs, and certain manual wheelchairs” for “such wheelchairs”.

2018—Subsec. (b)(10)(A). Pub. L. 115–123, § 50414(a)(1)(A), substituted “With respect to bids to furnish such types of products on or after January 1, 2019, the volume for such types of products shall be determined by the Secretary through the use of multiple sources of data (from mail order and non-mail order Medicare markets), including market-based data measuring sales of diabetic testing strip products that are not exclusively sold by a single retailer from such markets.” for “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.”

Subsec. (b)(10)(C) to (E). Pub. L. 115–123, § 50414(a)(1)(B), added subpars. (C) to (E).

Subsec. (b)(11), (12). Pub. L. 115–123, § 50414(b), added par. (11) and redesignated former par. (11) as (12).

2016—Subsec. (a)(2)(A). Pub. L. 114–255 substituted “, excluding certain” for “and excluding certain” and inserted before period at end “, and excluding drugs and biologicals described in section 1395u(o)(1)(D) of this title”.

2015—Subsec. (a)(1)(G), (H). Pub. L. 114–10, § 522(a), added subpars. (G) and (H).

Subsec. (b)(2)(A)(v). Pub. L. 114–10, § 522(b)(1), added cl. (v).

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. 108–173 amended 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. 106–113 inserted “and” after “specified by the Secretary”.

Statutory Notes and Related Subsidiaries

Effective Date of 2008 Amendment

Amendment by section 154 of Pub. L. 110–275 effective June 30, 2008, see section 154(e) of Pub. L. 110–275, set out as a note under section 1395m of this title.

Effective Date of 1999 Amendment

Amendment by Pub. L. 106–113 effective 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.

Construction of 2015 Amendment

Pub. L. 114–10, title V, § 522(b)(2), Apr. 16, 2015, 129 Stat. 177, provided that: “Nothing in the amendment made by paragraph (1) [amending this section] shall be construed as affecting the authority of the Secretary of Health and Human Services to require State licensure of an entity under the Medicare competitive acquisition program under section 1847 of the Social Security Act (42 U.S.C. 1395w–3) before the date of the enactment of this Act [Apr. 16, 2015].”

Non-Application of Medicare Fee Schedule Adjustments for Wheelchair Accessories and Seat and Back Cushions When Furnished in Connection With Complex Rehabilitative Manual Wheelchairs

Pub. L. 116–94, div. N, title I, § 106(b), Dec. 20, 2019, 133 Stat. 3101, provided that:

“(1)

In general.—

Notwithstanding any other provision of law, the Secretary of Health and Human Services shall not, during the period beginning on January 1, 2020, and ending on June 30, 2021, use information on the payment determined under the competitive acquisition programs under section 1847 of the Social Security Act (42 U.S.C. 1395w–3) to adjust the payment amount that would otherwise be recognized under section 1834(a)(1)(B)(ii) of such Act (42 U.S.C. 1395m(a)(1)(B)(ii)) for wheelchair accessories (including seating systems) and seat and back cushions when furnished in connection with complex rehabilitative manual wheelchairs (as determined by the Secretary), and certain manual wheelchairs (identified, as of October 1, 2018, by HCPCS codes E1235, E1236, E1237, E1238, and K0008 or any successor to such codes).

“(2)

Implementation.—

Notwithstanding any other provision of law, the Secretary may implement this subsection by program instruction or otherwise.”

Implementation of 2018 Amendment

Pub. L. 115–123, div. E, title IV, § 50414(c), Feb. 9, 2018, 132 Stat. 223, provided that:

“(1)

Implementation.—

Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the provisions of, and amendments made by, this section [amending this section] by program instruction or otherwise.

“(2)

Non-application of the paperwork reduction act.—

Chapter 35 of title 44, United States Code (commonly referred to as the ‘Paperwork Reduction Act of 1995’), shall not apply to this section or the amendments made by this section.”

GAO Report on Impact of Competitive Acquisition on Suppliers

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 [42 U.S.C. 1395w–3], 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.”

Report on Activities of Suppliers

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 [42 U.S.C. 1395w–3], 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.”

Study by GAO

Pub. L. 105–33, title IV, § 4319(c), Aug. 5, 1997, 111 Stat. 394, provided 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 [42 U.S.C. 1395w–3(a)], as added by this section.”