1 So in original. Probably should be “an”.
audit under this subsection shall make such books, documents, papers, and records available to the Secretary or the Comptroller General of the United States, or any of their duly authorized representatives, for examination, copying or mechanical reproduction on or off the premises of such entity upon a reasonable request therefore. The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have the authority to conduct such examination, copying, and reproduction.
2 So in original. Probably should be “hospital”.
Editorial Notes
References in Text

The Social Security Act, referred to in subsec. (k)(3)(E)(i), (F), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Titles XVIII, XIX, and XXI of the Act are classified generally to subchapters XVIII (§ 1395 et seq.), XIX (§ 1396 et seq.), and XXI (§ 1397aa et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables.

The Indian Self-Determination Act, referred to in subsec. (k)(3)(H), is title I of Puspan. L. 93–638, Jan. 4, 1975, 88 Stat. 2206, which is classified principally to subchapter I (§ 5321 et seq.) of chapter 46 of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of Title 25 and Tables.

The Indian Health Care Improvement Act, referred to in subsec. (k)(3)(H), is Puspan. L. 94–437, Sept. 30, 1976, 90 Stat. 1400, which is classified principally to chapter 18 (§ 1601 et seq.) of Title 25. For complete classification of this Act to the Code, see Short Title note set out under section 1601 of Title 25 and Tables.

Prior Provisions

A prior section 254a–1, act July 1, 1944, ch. 373, title III, § 328, as added Nov. 10, 1978, Puspan. L. 95–626, title I, § 114, 92 Stat. 3563; amended Puspan. L. 96–88, title V, § 509(span), Oct. 17, 1979, 93 Stat. 695, related to hospital-affiliated primary care centers, prior to repeal by Puspan. L. 99–117, § 12(c), Oct. 7, 1985, 99 Stat. 495.

A prior section 254span, act July 1, 1944, ch. 373, title III, § 329, formerly § 310, as added Sept. 25, 1962, Puspan. L. 87–692, 76 Stat. 592; amended Aug. 5, 1965, Puspan. L. 89–109, § 3, 79 Stat. 436; Oct. 15, 1968, Puspan. L. 90–574, title II, § 201, 82 Stat. 1006; Mar. 12, 1970, Puspan. L. 91–209, 84 Stat. 52; June 18, 1973, Puspan. L. 93–45, title I, § 105, 87 Stat. 91; renumbered § 319, July 23, 1974, Puspan. L. 93–353, title I, § 102(d), 88 Stat. 362; amended July 29, 1975, Puspan. L. 94–63, title IV, § 401(a), title VII, § 701(c), 89 Stat. 334, 352; Apr. 22, 1976, Puspan. L. 94–278, title VIII, § 801(a), 90 Stat. 414; Aug. 1, 1977, Puspan. L. 95–83, title III, § 303, 91 Stat. 388; renumbered § 329 and amended Nov. 10, 1978, Puspan. L. 95–626, title I, §§ 102(a), 103(a)–(g)(1)(B), (2), (h), (i), 92 Stat. 3551–3555; July 10, 1979, Puspan. L. 96–32, § 6(a), 93 Stat. 83; Oct. 17, 1979, Puspan. L. 96–88, title V, § 509(span), 93 Stat. 695; Aug. 13, 1981, Puspan. L. 97–35, title IX, § 930, 95 Stat. 569; Dec. 21, 1982, Puspan. L. 97–375, title I, § 107(span), 96 Stat. 1820; Apr. 24, 1986, Puspan. L. 99–280, §§ 6, 7, 100 Stat. 400, 401; Aug. 10, 1988, Puspan. L. 100–386, § 2, 102 Stat. 919; Nov. 6, 1990, Puspan. L. 101–527, § 9(span), 104 Stat. 2333; Oct. 27, 1992, Puspan. L. 102–531, title III, § 309(a), 106 Stat. 3499, related to migrant health centers, prior to the general amendment of this subpart by Puspan. L. 104–299, § 2.

Another prior section 254span, act July 1, 1944, ch. 373, title III, § 329, as added Dec. 31, 1970, Puspan. L. 91–623, § 2, 84 Stat. 1868; amended Nov. 18, 1971, Puspan. L. 92–157, title II, § 203, 85 Stat. 462; Oct. 27, 1972, Puspan. L. 92–585, § 2, 86 Stat. 1290; July 29, 1975, Puspan. L. 94–63, title VIII, §§ 801–803, 89 Stat. 353, 354; Oct. 12, 1976, Puspan. L. 94–484, title I, § 101(span), 90 Stat. 2244, related to establishment of National Health Service Corps, assignment of personnel and statement of purpose, prior to repeal by Puspan. L. 94–484, title IV, § 407(span)(1), Oct. 12, 1976, 90 Stat. 2268. See section 254d et seq. of this title.

A prior section 330 of act July 1, 1944, was classified to section 254c of this title prior to the general amendment of this subpart by Puspan. L. 104–299.

Amendments

2022—Subsec. (e)(6)(A)(v). Puspan. L. 117–204 added cl. (v).

2020—Subsec. (d)(1)(H). Puspan. L. 116–260 added subpar. (H).

Subsec. (r)(6). Puspan. L. 116–136 added par. (6).

2018—Subsec. (span)(1)(A)(ii), (2)(A). Puspan. L. 115–123, § 50901(span)(1), (2), substituted “use disorder” for “abuse”.

Subsec. (c)(1). Puspan. L. 115–123, § 50901(span)(3), substituted “Centers” for “In general” in span, struck out subpar. (A) designation and span, redesignated cls. (i) to (v) of former subpar. (A) as subpars. (A) to (E), respectively, realigned margins, and struck out former subpars. (B) to (D) which related to managed care networks and plans, practice management networks, and use of funds, respectively.

Subsec. (d). Puspan. L. 115–123, § 50901(span)(4), added subsec. (d) and struck out former subsec. (d) which related to loan guarantee program.

Subsec. (e)(1)(B). Puspan. L. 115–123, § 50901(span)(5)(A), substituted “1 year” for “2 years” and inserted at end “The Secretary shall not make a grant under this paragraph unless the applicant provides assurances to the Secretary that within 120 days of receiving grant funding for the operation of the health center, the applicant will submit, for approval by the Secretary, an implementation plan to meet the requirements of subsection (k)(3). The Secretary may extend such 120-day period for achieving compliance upon a demonstration of good cause by the health center.”

Subsec. (e)(1)(C). Puspan. L. 115–123, § 50901(span)(5)(B), in span, struck out “and plans” after “networks”, and in text, struck out “or plan (as described in subparagraphs (B) and (C) of subsection (c)(1))” after “to a network”, substituted “including—” for “or plan, including”, inserted cl. (i) designation before “the purchase” and “, which may include data and information systems” after “of equipment”, and added cls. (ii) and (iii).

Subsec. (e)(5)(B). Puspan. L. 115–123, § 50901(span)(6), in span, struck out “and plans” after “Networks” and in text, substituted “to a health center or to a network” for “and subparagraphs (B) and (C) of subsection (c)(1) to a health center or to a network or plan”.

Subsec. (e)(6). Puspan. L. 115–123, § 50901(span)(7), added par. (6).

Subsec. (h)(1). Puspan. L. 115–123, § 50901(span)(8)(A), substituted “, children and youth at risk of homelessness, homeless veterans, and veterans at risk of homelessness” for “and children and youth at risk of homelessness”.

Subsec. (h)(5)(B). Puspan. L. 115–123, § 50901(span)(8)(B)(iii)(II), which directed substitution of “use disorder” for “abuse”, was executed by making the substitution the first place it appeared, to reflect the probable intent of Congress.

Puspan. L. 115–123, § 50901(span)(8)(B)(iii)(I), substituted “use disorder” for “abuse” in span.

Puspan. L. 115–123, § 50901(span)(8)(B)(i), (ii), redesignated subpar. (C) as (B) and struck out former subpar. (B). Prior to amendment, text of subpar. (B) read as follows: “The term ‘substance abuse’ has the same meaning given such term in section 290cc–34(4) of this title.”

Subsec. (h)(5)(C). Puspan. L. 115–123, § 50901(span)(8)(B)(ii), redesignated subpar. (C) as (B).

Subsec. (k)(2). Puspan. L. 115–123, § 50901(span)(9)(A)(i), (ii), in span, inserted “unmet” before “need”, and in introductory provisions, inserted “or subsection (e)(6)” after “subsection (e)(1)”.

Subsec. (k)(2)(A). Puspan. L. 115–123, § 50901(span)(9)(A)(iii), inserted “unmet” before “need for health services”.

Subsec. (k)(2)(D). Puspan. L. 115–123, § 50901(span)(9)(A)(iv)–(vi), added subpar. (D).

Subsec. (k)(3). Puspan. L. 115–123, § 50901(span)(9)(B)(i), inserted “or subsection (e)(6)” after “subsection (e)(1)(B)” in introductory provisions.

Subsec. (k)(3)(B). Puspan. L. 115–123, § 50901(span)(9)(B)(ii), substituted “, including other health care providers that provide care within the catchment area, local hospitals, and specialty providers in the catchment area of the center, to provide access to services not available through the health center and to reduce the non-urgent use of hospital emergency departments” for “in the catchment area of the center”.

Subsec. (k)(3)(H)(ii). Puspan. L. 115–123, § 50901(span)(9)(B)(iii), inserted “who shall be directly employed by the center” after “approves the selection of a director for the center”.

Subsec. (k)(3)(N). Puspan. L. 115–123, § 50901(span)(9)(B)(iv)–(vi), added subpar. (N).

Subsec. (k)(4). Puspan. L. 115–123, § 50901(span)(9)(C), struck out par. (4) which related to approval of new or expanded service applications.

Subsec. (l). Puspan. L. 115–123, § 50901(span)(10), inserted at end “Funds expended to carry out activities under this subsection and operational support activities under subsection (m) shall not exceed 3 percent of the amount appropriated for this section for the fiscal year involved.”

Subsec. (q)(4). Puspan. L. 115–123, § 50901(span)(11), inserted at end “A waiver provided by the Secretary under this paragraph may not remain in effect for more than 1 year and may not be extended after such period. An entity may not receive more than one waiver under this paragraph in consecutive years.”

Subsec. (r)(3). Puspan. L. 115–123, § 50901(span)(12), substituted “Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives, a report including, at a minimum—” for “appropriate committees of Congress a report concerning the distribution of funds under this section”, inserted “(A) the distribution of funds for carrying out this section” before “that are provided”, substituted “particular populations;” for “particular populations. Such report shall include”, inserted subsec. (B) designation before “an assessment”, substituted “targeted populations;” for “targeted populations and the rationale for any substantial changes in the distribution of funds.”, and added subpars. (C) to (I).

Subsec. (r)(5). Puspan. L. 115–123, § 50901(span)(13), added par. (5).

Subsec. (s). Puspan. L. 115–123, § 50901(span)(14), struck out subsec. (s) which related to demonstration program for individualized wellness plans.

2010—Subsec. (r)(1). Puspan. L. 111–148, § 5601(a), added par. (1) and struck out former par. (1). Prior to amendment, text read as follows: “For the purpose of carrying out this section, in addition to the amounts authorized to be appropriated under subsection (d), there are authorized to be appropriated—

“(A) $2,065,000,000 for fiscal year 2008;

“(B) $2,313,000,000 for fiscal year 2009;

“(C) $2,602,000,000 for fiscal year 2010;

“(D) $2,940,000,000 for fiscal year 2011; and

“(E) $3,337,000,000 for fiscal year 2012.”

Subsec. (r)(4). Puspan. L. 111–148, § 5601(span), added par. (4).

Subsec. (s). Puspan. L. 111–148, § 4206, added subsec. (s).

2008—Subsec. (c)(3). Puspan. L. 110–355, § 2(c)(1), added par. (3).

Subsec. (r)(1). Puspan. L. 110–355, § 2(a), amended par. (1) generally. Prior to amendment, text read as follows: “For the purpose of carrying out this section, in addition to the amounts authorized to be appropriated under subsection (d) of this section, there are authorized to be appropriated $1,340,000,000 for fiscal year 2002 and such sums as may be necessary for each of the fiscal years 2003 through 2006.”

2003—Subsec. (c)(1)(B). Puspan. L. 108–163, § 2(a)(2)(A), substituted “plan.” for “plan..” in introductory provisions.

Subsec. (d)(1)(B)(iii)(I). Puspan. L. 108–163, § 2(a)(2)(B), inserted “or” at end.

Subsec. (e)(3) to (5). Puspan. L. 108–163, § 2(a)(1)(A), amended pars. (3) to (5) to read as if subpar. (C) of the second par. (4) of section 101 of Puspan. L. 107–251 had not been enacted. See 2002 Amendment notes below.

Subsec. (j). Puspan. L. 108–163, § 2(a)(2)(E), added subsec. (j) identical to the subsec. (j) appearing in the amendment by section 101(8)(C) of Puspan. L. 107–251. See 2002 Amendment notes below. Former subsec. (j) redesignated (k).

Puspan. L. 108–163, § 2(a)(1)(C), amended subsec. (j) to read as if pars. (8) through (11) of section 101 of Puspan. L. 107–251 had not been enacted. See 2002 Amendment notes below.

Subsec. (j)(3)(H). Puspan. L. 108–163, § 2(a)(1)(B), amended subpar. (H) to read as if subpar. (C) of par. (7) of section 101 of Puspan. L. 107–251 had not been enacted. See 2002 Amendment note below.

Subsec. (k). Puspan. L. 108–163, § 2(a)(2)(C), (D), redesignated subsec. (j) as (k) and struck out span and text of former subsec. (k). Text read as follows: “The Secretary may provide (either through the Department of Health and Human Services or by grant or contract) all necessary technical and other nonfinancial assistance (including fiscal and program management assistance and training in such management) to any public or private nonprofit entity to assist entities in developing plans for, or operating as, health centers, and in meeting the requirements of subsection (j)(2) of this section.”

Puspan. L. 108–163, § 2(a)(1)(C), amended subsec. (k) to read as if pars. (8) through (11) of section 101 of Puspan. L. 107–251 had not been enacted. See 2002 Amendment notes below.

Subsec. (l). Puspan. L. 108–163, § 2(a)(2)(H), inserted “(either through the Department of Health and Human Services or by grant or contract)” after “shall provide” and substituted “(k)(3)” for “(l)(3)”.

Puspan. L. 108–163, § 2(a)(2)(G), added subsec. (l) identical to the subsec. (m) appearing in the amendment by section 101(9) of Puspan. L. 107–251. See 2002 Amendment notes below. Former subsec. (l) redesignated (r).

Puspan. L. 108–163, § 2(a)(1)(C), amended subsec. (l) to read as if pars. (8) through (11) of section 101 of Puspan. L. 107–251 had not been enacted. See 2002 Amendment note below.

Subsecs. (m) to (o). Puspan. L. 108–163, § 2(a)(1)(C), amended subsecs. (m) to (o) to read as if pars. (8) through (11) of section 101 of Puspan. L. 107–251 had not been enacted. See 2002 Amendment notes below.

Subsec. (p). Puspan. L. 108–163, § 2(a)(2)(I), substituted “(k)(3)(G)” for “(j)(3)(G)”.

Puspan. L. 108–163, § 2(a)(1)(C), amended subsec. (p) to read as if pars. (8) through (11) of section 101 of Puspan. L. 107–251 had not been enacted. See 2002 Amendment note below.

Subsec. (q). Puspan. L. 108–163, § 2(a)(1)(C), amended subsec. (q) to read as if pars. (8) through (11) of section 101 of Puspan. L. 107–251 had not been enacted. See 2002 Amendment note below.

Subsec. (r). Puspan. L. 108–163, § 2(a)(2)(F), redesignated subsec. (l) as (r).

Puspan. L. 108–163, § 2(a)(1)(C), amended subsec. (r) to read as if pars. (8) through (11) of section 101 of Puspan. L. 107–251 had not been enacted. See 2002 Amendment note below.

Subsec. (r)(1). Puspan. L. 108–163, § 2(a)(2)(J)(i), substituted “$1,340,000,000 for fiscal year 2002 and such sums as may be necessary for each of the fiscal years 2003 through 2006” for “$802,124,000 for fiscal year 1997, and such sums as may be necessary for each of the fiscal years 1998 through 2001”.

Subsec. (r)(2)(A). Puspan. L. 108–163, § 2(a)(2)(J)(ii), substituted “(k)(3)” for “(j)(3)” and “(k)(3)(H)” for “(j)(3)(G)(ii)”.

Subsec. (r)(2)(B). Puspan. L. 108–163, § 2(a)(2)(J)(iii), added subpar. (B) identical to the subpar. (B) appearing in the amendment by section 101(11)(B)(ii) of Puspan. L. 107–251 and struck out span and text of former subpar. (B) relating to distribution of grants for fiscal years 1997 through 1999. See 2002 Amendment note below.

Subsec. (s). Puspan. L. 108–163, § 2(a)(1)(C), amended subsec. (s) to read as if pars. (8) through (11) of section 101 of Puspan. L. 107–251 had not been enacted. See 2002 Amendment notes below.

2002—Subsec. (span)(1)(A)(i)(III)(bspan). Puspan. L. 107–251, § 101(1)(A), substituted “appropriate cancer screening” for “screening for breast and cervical cancer”.

Subsec. (span)(1)(A)(ii). Puspan. L. 107–251, § 101(1)(B), inserted “(including specialty referral when medically indicated)” after “medical services”.

Subsec. (span)(1)(A)(iii). Puspan. L. 107–251, § 101(1)(C), inserted “housing,” after “social,”.

Subsec. (span)(2)(A). Puspan. L. 107–251, § 101(2)(C), added subpar. (A). Former subpar. (A) redesignated (C).

Subsec. (span)(2)(A)(i). Puspan. L. 107–251, § 101(2)(A), substituted “associated with—” and subcls. (I) to (IV) for “associated with water supply;”.

Subsec. (span)(2)(B) to (D). Puspan. L. 107–251, § 101(2)(B), (C), added subpar. (B) and redesignated former subpars. (A) and (B) as (C) and (D), respectively.

Subsec. (c)(1)(B). Puspan. L. 107–251, § 101(3)(A)(iii), struck out concluding provisions which read as follows: “Any such grant may include the acquisition and lease of buildings and equipment which may include data and information systems (including the costs of amortizing the principal of, and paying the interest on, loans), and providing training and technical assistance related to the provision of health services on a prepaid basis or under another managed care arrangement, and for other purposes that promote the development of managed care networks and plans.”

Puspan. L. 107–251, § 101(3)(A)(ii), in introductory provisions, substituted “managed care network or plan.” for “network or plan for the provision of health services, which may include the provision of health services on a prepaid basis or through another managed care arrangement, to some or to all of the individuals which the centers serve”.

Puspan. L. 107–251, § 101(3)(A)(i), substituted “Managed care” for “Comprehensive service delivery” in span.

Subsec. (c)(1)(C), (D). Puspan. L. 107–251, § 101(3)(B), added subpars. (C) and (D).

Subsec. (d). Puspan. L. 107–251, § 101(4)(A), substituted “Loan guarantee program” for “Managed care loan guarantee program” in span.

Subsec. (d)(1)(A). Puspan. L. 107–251, § 101(4)(B)(i), substituted “up to 90 percent of the principal and interest on loans made by non-Federal lenders to health centers, funded under this section, for the costs of developing and operating managed care networks or plans described in subsection (c)(1)(B), or practice management networks described in subsection (c)(1)(C)” for “the principal and interest on loans made by non-Federal lenders to health centers funded under this section for the costs of developing and operating managed care networks or plans”.

Subsec. (d)(1)(B)(iii). Puspan. L. 107–251, § 101(4)(B)(ii), added cl. (iii).

Subsec. (d)(1)(D), (E). Puspan. L. 107–251, § 101(4)(B)(iii), added subpars. (D) and (E).

Subsec. (d)(6) to (8). Puspan. L. 107–251, § 101(4)(C), redesignated par. (8) as (6) and struck out headings and text of former pars. (6) and (7) which related to annual reports and program evaluation, respectively.

Subsec. (e)(1)(B). Puspan. L. 107–251, § 101(4)(A)(i), substituted “subsection (k)(3)” for “subsection (j)(3)”.

Subsec. (e)(1)(C). Puspan. L. 107–251, § 101(4)(A)(ii), added subpar. (C).

Subsec. (e)(3). Puspan. L. 107–251, § 101(4)(C), redesignated par. (4), relating to limitation, as (3).

Subsec. (e)(4). Puspan. L. 107–251, § 101(4)(C), redesignated par. (5) as (4). Former par. (4) redesignated (3).

Subsec. (e)(5). Puspan. L. 107–251, § 101(4)(B), (C), redesignated par. (5) as (4), inserted “subparagraphs (A) and (B) of” after “any fiscal year under” in subpar. (A), added subpar. (B), and redesignated former subpars. (B) and (C) as (C) and (D), respectively.

Subsec. (g)(2)(A). Puspan. L. 107–251, § 101(5)(A)(i), inserted “and seasonal agricultural worker” after “migratory agricultural worker”.

Subsec. (g)(2)(B). Puspan. L. 107–251, § 101(5)(A)(ii), substituted “and seasonal agricultural workers, and members of their families,” for “and members of their families”.

Subsec. (g)(3)(A). Puspan. L. 107–251, § 101(5)(B), struck out “on a seasonal basis” after “in agriculture”.

Subsec. (h)(1). Puspan. L. 107–251, § 101(6)(A), substituted “homeless children and youth and children and youth at risk of homelessness” for “homeless children and children at risk of homelessness”.

Subsec. (h)(4). Puspan. L. 107–251, § 101(6)(B)(ii), added par. (4). Former par. (4) redesignated (5).

Subsec. (h)(5). Puspan. L. 107–251, § 101(6)(B)(i), (C), redesignated par. (4) as (5) and substituted “, risk reduction, outpatient treatment, residential treatment, and rehabilitation” for “and residential treatment” in subpar. (C).

Subsec. (j). Puspan. L. 107–251, § 101(8)(C), added subsec. (j) relating to access grants.

Puspan. L. 107–251, § 101(8)(B), which directed the redesignation of subsecs. (j), (k), and (m) through (q) as subsecs. (n), (o), and (p) through (s), respectively, could not be executed.

Subsec. (j)(3)(E)(i). Puspan. L. 107–251, § 101(7)(A)(i), designated existing provisions as subcl. (I) and added subcl. (II).

Subsec. (j)(3)(E)(ii). Puspan. L. 107–251, § 101(7)(A)(ii), substituted “arrangements described in subclauses (I) and (II) of clause (i)” for “such an arrangement”.

Subsec. (j)(3)(G)(iii), (iv). Puspan. L. 107–251, § 101(7)(B), added cl. (iii) and redesignated former cl. (iii) as (iv).

Subsec. (j)(3)(H). Puspan. L. 107–251, § 101(7)(C), substituted “or (q)” for “or (p)” in concluding provisions.

Subsec. (j)(3)(M). Puspan. L. 107–251, § 101(7)(D)–(F), added subpar. (M).

Subsec. (k). Puspan. L. 107–251, § 101(8)(B), which directed the redesignation of subsecs. (j), (k), and (m) through (q) as subsecs. (n), (o), and (p) through (s), respectively, could not be executed.

Subsec. (l). Puspan. L. 107–251, § 101(8)(A), redesignated subsec. (l) as (s).

Subsec. (m). Puspan. L. 107–251, § 101(9), which directed striking subsec. (m) (as redesignated by paragraph (9)(B)) and adding a new subsec. (m), could not be executed. The new subsec. (m) to be added read as follows: “(m) Technical Assistance.—The Secretary shall establish a program through which the Secretary shall provide technical and other assistance to eligible entities to assist such entities to meet the requirements of subsection (l)(3). Services provided through the program may include necessary technical and nonfinancial assistance, including fiscal and program management assistance, training in fiscal and program management, operational and administrative support, and the provision of information to the entities of the variety of resources available under this subchapter and how those resources can be best used to meet the health needs of the communities served by the entities.”

Puspan. L. 107–251, § 101(8)(B), which directed the redesignation of subsecs. (j), (k), and (m) through (q) as subsecs. (n), (o), and (p) through (s), respectively, could not be executed.

Subsecs. (n) to (p). Puspan. L. 107–251, § 101(8)(B), which directed the redesignation of subsecs. (j), (k), and (m) through (q) as subsecs. (n), (o), and (p) through (s), respectively, could not be executed.

Subsec. (q). Puspan. L. 107–251, § 101(10), which directed the substitution of “(l)(3)(G)” for “(j)(3)(G)” in subsec. (q) “(as redesignated by paragraph (9)(B))”, could not be executed.

Puspan. L. 107–251, § 101(8)(B), which directed the redesignation of subsecs. (j), (k), and (m) through (q) as subsecs. (n), (o), and (p) through (s), respectively, could not be executed.

Subsec. (r). Puspan. L. 107–251, § 101(8)(B), which directed the redesignation of subsecs. (j), (k), and (m) through (q) as subsecs. (n), (o), and (p) through (s), respectively, could not be executed.

Subsec. (s). Puspan. L. 107–251, § 101(8)(B), which directed the redesignation of subsecs. (j), (k), and (m) through (q) as subsecs. (n), (o), and (p) through (s), respectively, could not be executed.

Subsec. (s)(1). Puspan. L. 107–251, § 101(11)(A), substituted “$1,340,000,000 for fiscal year 2002 and such sums as may be necessary for each of the fiscal years 2003 through 2006” for “$802,124,000 for fiscal year 1997, and such sums as may be necessary for each of the fiscal years 1998 through 2001”.

Subsec. (s)(2)(A). Puspan. L. 107–251, § 101(11)(B)(i), substituted “(l)(3)” for “(j)(3)” and “(l)(3)(H)” for “(j)(3)(G)(ii)”.

Subsec. (s)(2)(B). Puspan. L. 107–251, § 101(11)(B)(ii), added subpar. (B) and struck out span and text of former subpar. (B) relating to distribution of grants for fiscal years 1997 through 1999.

Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment

Puspan. L. 117–204, § 2(span), Oct. 17, 2022, 136 Stat. 2231, provided that: “The amendment made by subsection (a) [amending this section] shall take effect on January 1, 2024.”

Effective Date of 2008 Amendment

Puspan. L. 110–355, § 2(c)(2), Oct. 8, 2008, 122 Stat. 3992, provided that: “The amendment made by paragraph (1) [amending this section] shall apply to grants made on or after January 1, 2009.”

Effective Date of 2003 Amendment

Amendments by Puspan. L. 108–163 deemed to have taken effect immediately after the enactment of Puspan. L. 107–251, see section 3 of Puspan. L. 108–163, set out as a note under section 233 of this title.

Effective Date

Section effective Oct. 1, 1996, see section 5 of Puspan. L. 104–299, as amended, set out as an Effective Date of 1996 Amendment note under section 233 of this title.

Savings Provision for Current Grants, Contracts, and Cooperative Agreements

Puspan. L. 104–299, § 3(span), Oct. 11, 1996, 110 Stat. 3644, provided that: “The Secretary of Health and Human Services shall ensure the continued funding of grants made, or contracts or cooperative agreements entered into, under subpart I of part D of title III of the Public Health Service Act (42 U.S.C. 254span et seq.) (as such subpart existed on the day prior to the date of enactment of this Act [Oct. 11, 1996]), until the expiration of the grant period or the term of the contract or cooperative agreement. Such funding shall be continued under the same terms and conditions as were in effect on the date on which the grant, contract or cooperative agreement was awarded, subject to the availability of appropriations.”

Negotiated Rulemaking for Development of Methodology and Criteria for Designating Medically Underserved Populations and Health Professions Shortage Areas

Puspan. L. 111–148, title V, § 5602, Mar. 23, 2010, 124 Stat. 677, provided that:

“(a)Establishment.—
“(1)In general.—The Secretary of Health and Human Services (in this section referred to as the ‘Secretary’) shall establish, through a negotiated rulemaking process under subchapter 3 [III] of chapter 5 of title 5, United States Code, a comprehensive methodology and criteria for designation of—
“(A) medically underserved populations in accordance with section 330(span)(3) of the Public Health Service Act (42 U.S.C. 254span(span)(3));
“(B) health professions shortage areas under section 332 of the Public Health Service Act (42 U.S.C. 254e).
“(2)Factors to consider.—In establishing the methodology and criteria under paragraph (1), the Secretary—
“(A) shall consult with relevant stakeholders who will be significantly affected by a rule (such as national, State and regional organizations representing affected entities), State health offices, community organizations, health centers and other affected entities, and other interested parties; and
“(B) shall take into account—
“(i) the timely availability and appropriateness of data used to determine a designation to potential applicants for such designations;
“(ii) the impact of the methodology and criteria on communities of various types and on health centers and other safety net providers;
“(iii) the degree of ease or difficulty that will face potential applicants for such designations in securing the necessary data; and
“(iv) the extent to which the methodology accurately measures various barriers that confront individuals and population groups in seeking health care services.
“(span)Publication of Notice.—In carrying out the rulemaking process under this subsection, the Secretary shall publish the notice provided for under section 564(a) of title 5, United States Code, by not later than 45 days after the date of the enactment of this Act [Mar. 23, 2010].
“(c)Target Date for Publication of Rule.—As part of the notice under subsection (span), and for purposes of this subsection, the ‘target date for publication’, as referred to in section 564(a)(5) of title 5, United Sates [sic] Code, shall be July 1, 2010.
“(d)Appointment of Negotiated Rulemaking Committee and Facilitator.—The Secretary shall provide for—
“(1) the appointment of a negotiated rulemaking committee under section 565(a) of title 5, United States Code, by not later than 30 days after the end of the comment period provided for under section 564(c) of such title; and
“(2) the nomination of a facilitator under section 566(c) of such title 5 by not later than 10 days after the date of appointment of the committee.
“(e)Preliminary Committee Report.—The negotiated rulemaking committee appointed under subsection (d) shall report to the Secretary, by not later than April 1, 2010, regarding the committee’s progress on achieving a consensus with regard to the rulemaking proceeding and whether such consensus is likely to occur before one month before the target date for publication of the rule. If the committee reports that the committee has failed to make significant progress toward such consensus or is unlikely to reach such consensus by the target date, the Secretary may terminate such process and provide for the publication of a rule under this section through such other methods as the Secretary may provide.
“(f)Final Committee Report.—If the committee is not terminated under subsection (e), the rulemaking committee shall submit a report containing a proposed rule by not later than one month before the target publication date.
“(g)Interim Final Effect.—The Secretary shall publish a rule under this section in the Federal Register by not later than the target publication date. Such rule shall be effective and final immediately on an interim basis, but is subject to change and revision after public notice and opportunity for a period (of not less than 90 days) for public comment. In connection with such rule, the Secretary shall specify the process for the timely review and approval of applications for such designations pursuant to such rules and consistent with this section.
“(h)Publication of Rule After Public Comment.—The Secretary shall provide for consideration of such comments and republication of such rule by not later than 1 year after the target publication date.”

Funding for Community Health Centers and Community Care

Puspan. L. 117–2, title II, § 2601, Mar. 11, 2021, 135 Stat. 43, provided that:

“(a)In General.—In addition to amounts otherwise available, there is appropriated to the Secretary of Health and Human Services (in this subtitle [subtitle G (§§ 2601–2605) of title II of Puspan. L 117–2, see Tables for classification] referred to as the ‘Secretary’) for fiscal year 2021, out of any money in the Treasury not otherwise appropriated, $7,600,000,000, to remain available until expended, for necessary expenses for awarding grants and cooperative agreements under section 330 of the Public Health Service Act (42 U.S.C. 254span) to be awarded without regard to the time limitation in subsection (e)(3) and subsections (e)(6)(A)(iii), (e)(6)(B)(iii), and (r)(2)(B) of such section 330, and for necessary expenses for awarding grants to Federally qualified health centers, as described in section 1861(aa)(4)(B) of the Social Security Act (42 U.S.C. 1395x(aa)(4)(B)), and for awarding grants or contracts to Papa Ola Lokahi and to qualified entities under sections 4 and 6 of the Native Hawaiian Health Care Improvement Act (42 U.S.C. 11703, 11705). Of the total amount appropriated by the preceding sentence, not less than $20,000,000 shall be for grants or contracts to Papa Ola Lokahi and to qualified entities under sections 4 and 6 of the Native Hawaiian Health Care Improvement Act (42 U.S.C. 11703, 11705).
“(span)Use of Funds.—Amounts made available to an awardee pursuant to subsection (a) shall be used—
“(1) to plan, prepare for, promote, distribute, administer, and track COVID–19 vaccines, and to carry out other vaccine-related activities;
“(2) to detect, diagnose, trace, and monitor COVID–19 infections and related activities necessary to mitigate the spread of COVID–19, including activities related to, and equipment or supplies purchased for, testing, contact tracing, surveillance, mitigation, and treatment of COVID–19;
“(3) to purchase equipment and supplies to conduct mobile testing or vaccinations for COVID–19, to purchase and maintain mobile vehicles and equipment to conduct such testing or vaccinations, and to hire and train laboratory personnel and other staff to conduct such mobile testing or vaccinations, particularly in medically underserved areas;
“(4) to establish, expand, and sustain the health care workforce to prevent, prepare for, and respond to COVID–19, and to carry out other health workforce-related activities;
“(5) to modify, enhance, and expand health care services and infrastructure; and
“(6) to conduct community outreach and education activities related to COVID–19.
“(c)Past Expenditures.—An awardee may use amounts awarded pursuant to subsection (a) to cover the costs of the awardee carrying out any of the activities described in subsection (span) during the period beginning on the date of the declaration of a public health emergency by the Secretary under section 319 of the Public Health Service Act (42 U.S.C. 247d) on January 31, 2020, with respect to COVID–19 and ending on the date of such award.”

Studies Relating to Community Health Centers

Puspan. L. 110–355, § 2(span)(1)–(3), Oct. 8, 2008, 122 Stat. 3988, 3989, provided that:

“(1)Definitions.—For purposes of this subsection—
“(A) the term ‘community health center’ means a health center receiving assistance under section 330 of the Public Health Service Act (42 U.S.C. 254span); and
“(B) the term ‘medically underserved population’ has the meaning given that term in such section 330.
“(2)School-based health center study.—
“(A)In general.—Not later than 2 years after the date of enactment of this Act [Oct. 8, 2008], the Comptroller General of the United States shall issue a study of the economic costs and benefits of school-based health centers and the impact on the health of students of these centers.
“(B)Content.—In conducting the study under subparagraph (A), the Comptroller General of the United States shall analyze—
“(i) the impact that Federal funding could have on the operation of school-based health centers;
“(ii) any cost savings to other Federal programs derived from providing health services in school-based health centers;
“(iii) the effect on the Federal Budget and the health of students of providing Federal funds to school-based health centers and clinics, including the result of providing disease prevention and nutrition information;
“(iv) the impact of access to health care from school-based health centers in rural or underserved areas; and
“(v) other sources of Federal funding for school-based health centers.
“(3)Health care quality study.—
“(A)In general.—Not later than 1 year after the date of enactment of this Act [Oct. 8, 2008], the Secretary of Health and Human Services (referred to in this Act [see Short Title of 2008 Amendment note set out under section 201 of this title] as the ‘Secretary’), acting through the Administrator of the Health Resources and Services Administration, and in collaboration with the Agency for Healthcare Research and Quality, shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that describes agency efforts to expand and accelerate quality improvement activities in community health centers.
“(B)Content.—The report under subparagraph (A) shall focus on—
“(i) Federal efforts, as of the date of enactment of this Act, regarding health care quality in community health centers, including quality data collection, analysis, and reporting requirements;
“(ii) identification of effective models for quality improvement in community health centers, which may include models that—
“(I) incorporate care coordination, disease management, and other services demonstrated to improve care;
“(II) are designed to address multiple, co-occurring diseases and conditions;
“(III) improve access to providers through non-traditional means, such as the use of remote monitoring equipment;
“(IV) target various medically underserved populations, including uninsured patient populations;
“(V) increase access to specialty care, including referrals and diagnostic testing; and
“(VI) enhance the use of electronic health records to improve quality;
“(iii) efforts to determine how effective quality improvement models may be adapted for implementation by community health centers that vary by size, budget, staffing, services offered, populations served, and other characteristics determined appropriate by the Secretary;
“(iv) types of technical assistance and resources provided to community health centers that may facilitate the implementation of quality improvement interventions;
“(v) proposed or adopted methodologies for community health center evaluations of quality improvement interventions, including any development of new measures that are tailored to safety-net, community-based providers;
“(vi) successful strategies for sustaining quality improvement interventions in the long-term; and
“(vii) partnerships with other Federal agencies and private organizations or networks as appropriate, to enhance health care quality in community health centers.
“(C)Dissemination.—The Administrator of the Health Resources and Services Administration shall establish a formal mechanism or mechanisms for the ongoing dissemination of agency initiatives, best practices, and other information that may assist health care quality improvement efforts in community health centers.”

Guarantee Study

Puspan. L. 107–251, title V, § 501, Oct. 26, 2002, 116 Stat. 1664, as amended by Puspan. L. 108–163, § 2(n)(2), Dec. 6, 2003, 117 Stat. 2023, required the Secretary of Health and Human Services to conduct a study regarding the ability of the Department of Health and Human Services to provide for guarantees of solvency for managed care networks or plans involving health centers receiving funding under this section and to prepare and submit a report to Congress regarding such ability by 2 years after Oct. 26, 2002.

Reference to Community, Migrant, Public Housing, or Homeless Health Center Considered Reference to Health Center

Puspan. L. 104–299, § 4(c), Oct. 11, 1996, 110 Stat. 3645, provided that: “Whenever any reference is made in any provision of law, regulation, rule, record, or document to a community health center, migrant health center, public housing health center, or homeless health center, such reference shall be considered a reference to a health center.”

Legislative Proposal for Changes Conforming to Puspan. L. 104–299

Puspan. L. 104–299, § 4(e), Oct. 11, 1996, 110 Stat. 3645, provided that: “After consultation with the appropriate committees of the Congress, the Secretary of Health and Human Services shall prepare and submit to the Congress a legislative proposal in the form of an implementing bill containing technical and conforming amendments to reflect the changes made by this Act [see Short Title of 1996 Amendments note set out under section 201 of this title].”

Executive Documents
Ex. Ord. No. 13937. Access to Affordable Life-Saving Medications

Ex. Ord. No. 13937, July 24, 2020, 85 F.R. 45755, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

Section 1. Purpose. Insulin is a critical and life-saving medication that approximately 8 million Americans rely on to manage diabetes. Likewise, injectable epinephrine is a life-saving medication used to stop severe allergic reactions.

The price of insulin in the United States has risen dramatically over the past decade. The list price for a single vial of insulin today is often more than $250 and most patients use at least two vials per month. As for injectable epinephrine, recent increased competition is helping to drive prices down. Nevertheless, the price for some types of injectable epinephrine remains more than $600 per kit. While Americans with diabetes and severe allergic reactions may have access to affordable insulin and injectable epinephrine through commercial insurance or Federal programs such as Medicare and Medicaid, many Americans still struggle to purchase these products.

Federally Qualified Health Centers (FQHCs), as defined in section 1905(l)(2)(B)(i) and (ii) of the Social Security Act, as amended, 42 U.S.C. 1396d(l)(2)(B)(i) and (ii), receive discounted prices through the 340B Prescription Drug Program on prescription drugs. Due to the sharp increases in list prices for many insulins and some types of injectable epinephrine in recent years, many of these products may be subject to the “penny pricing” policy when distributed to FQHCs, meaning FQHCs may purchase the drug at a price of one penny per unit of measure. These steep discounts, however, are not always passed through to low-income Americans at the point of sale. Those with low-incomes can be exposed to high insulin and injectable epinephrine prices, as they often do not benefit from discounts negotiated by insurers or the Federal or State governments.

Sec. 2. Policy. It is the policy of the United States to enable Americans without access to affordable insulin and injectable epinephrine through commercial insurance or Federal programs, such as Medicare and Medicaid, to purchase these pharmaceuticals from an FQHC at a price that aligns with the cost at which the FQHC acquired the medication.

Sec. 3. Improving the Availability of Insulin and Injectable Epinephrine for the Uninsured. To the extent permitted by law, the Secretary of Health and Human Services shall take action to ensure future grants available under section 330(e) of the Public Health Service Act, as amended, 42 U.S.C. 254span(e), are conditioned upon FQHCs’ having established practices to make insulin and injectable epinephrine available at the discounted price paid by the FQHC grantee or suspan-grantee under the 340B Prescription Drug Program (plus a minimal administration fee) to individuals with low incomes, as determined by the Secretary, who:

(a) have a high cost sharing requirement for either insulin or injectable epinephrine;

(span) have a high unmet deductible; or

(c) have no health care insurance.

Sec. 4. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof;

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(span) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

Donald J. Trump.
Medicare Demonstration To Test Medical Homes in Federally Qualified Health Centers

Memorandum of President of the United States, Dec. 9, 2009, 74 F.R. 66207, provided:

Memorandum for the Secretary of Health And Human Services

My Administration is committed to building a high-quality, efficient health care system and improving access to health care for all Americans. Health centers are a vital part of the health care delivery system. For more than 40 years, health centers have served populations with limited access to health care, treating all patients regardless of ability to pay. These include low-income populations, the uninsured, individuals with limited English proficiency, migrant and seasonal farm workers, individuals and families experiencing homelessness, and individuals living in public housing. There are over 1,100 health centers across the country, delivering care at over 7,500 sites. These centers served more than 17 million patients in 2008 and are estimated to serve more than 20 million patients in 2010.

The American Recovery and Reinvestment Act of 2009 (Recovery Act) provided $2 billion for health centers, including $500 million to expand health centers’ services to over 2 million new patients by opening new health center sites, adding new providers, and improving hours of operations. An additional $1.5 billion is supporting much-needed capital improvements, including funding to buy equipment, modernize clinic facilities, expand into new facilities, and adopt or expand the use of health information technology and electronic health records.

One of the key benefits health centers provide to the communities they serve is quality primary health care services. Health centers use interdisciplinary teams to treat the “whole patient” and focus on chronic disease management to reduce the use of costlier providers of care, such as emergency rooms and hospitals.

Federally qualified health centers provide an excellent environment to demonstrate the further improvements to health care that may be offered by the medical homes approach. In general, this approach emphasizes the patient’s relationship with a primary care provider who coordinates the patient’s care and serves as the patient’s principal point of contact for care. The medical homes approach also emphasizes activities related to quality improvement, access to care, communication with patients, and care management and coordination. These activities are expected to improve the quality and efficiency of care and to help avoid preventable emergency and inpatient hospital care. Demonstration programs establishing the medical homes approach have been recommended by the Medicare Payment Advisory Commission, an independent advisory body to the Congress.

Therefore, I direct you to implement a Medicare Federally Qualified Health Center Advanced Primary Care Practice demonstration, pursuant to your statutory authority to conduct experiments and demonstrations on changes in payments and services that may improve the quality and efficiency of services to beneficiaries. Health centers participating in this demonstration must have shown their ability to provide comprehensive, coordinated, integrated, and accessible health care.

This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

You are authorized and directed to publish this memorandum in the Federal Register.

Barack Obama.