42 U.S.C. § 256c — Bulk purchases of vaccines for certain

Page 442 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 256c paragraph (O) of such section 340B(a)(4), the require- ment with respect to the disproportionate share ad- justment percentage described in such subparagraph (O). ‘‘(d) SELF-ATTESTATION.— ‘‘(1) IN GENERAL.—A hospital described in sub- section (a) that fails to meet the applicable require- ment for the disproportionate share adjustment per- centage described in subsection (c) shall, within 30 days of such failure, or in the case of a hospital where such failure occurred prior to the date of enactment of this Act but after the start of the COVID-19 public health emergency, within 30 days of the date of en- actment, provide to the Secretary of Health and Human Services an attestation that contains infor- mation on any actions taken by or other impact on such hospital in response to or as a result of the COVID-19 public health emergency that may have im- pacted the ability to meet the applicable requirement for the disproportionate share adjustment percentage described in subsection (c). ‘‘(2) PAPERWORK REDUCTION ACT.—Chapter 35 of title 44, United States Code, shall not apply to the collec- tion of information provided pursuant to this sub- section. ‘‘(e) DEFINITIONS.—In this section: ‘‘(1) COVERED ENTITY.—The term ‘covered entity’ has the meaning given such term in section 340B(a)(4) of the Public Health Service Act (42 U.S.C. 256b(a)(4)). ‘‘(2) COVID–19 PUBLIC HEALTH EMERGENCY.—The term ‘COVID–19 public health emergency’ means the public health emergency declared by the Secretary of Health and Human Services under section 319 of the Public Health Service Act (42 U.S.C. 247d) on January 31, 2020, with respect to COVID–19 (or any renewal of such declaration).’’ PRICING OF DIAGNOSTIC TESTING Pub. L. 116–136, div. A, title III, § 3202, Mar. 27, 2020, 134 Stat. 367, provided that: ‘‘(a) REIMBURSEMENT RATES.—A group health plan or a health insurance issuer providing coverage of items and services described in section 6001(a) of division F of the Families First Coronavirus Response Act (Public Law 116–127) [42 U.S.C. 1320b–5 note] with respect to an enrollee shall reimburse the provider of the diagnostic testing as follows: ‘‘(1) If the health plan or issuer has a negotiated rate with such provider in effect before the public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d), such nego- tiated rate shall apply throughout the period of such declaration. ‘‘(2) If the health plan or issuer does not have a ne- gotiated rate with such provider, such plan or issuer shall reimburse the provider in an amount that equals the cash price for such service as listed by the provider on a public internet website, or such plan or issuer may negotiate a rate with such provider for less than such cash price. ‘‘(b) REQUIREMENT TO PUBLICIZE CASH PRICE FOR DIAG- NOSTIC TESTING FOR COVID–19.— ‘‘(1) IN GENERAL.—During the emergency period de- clared under section 319 of the Public Health Service Act (42 U.S.C. 247d), each provider of a diagnostic test for COVID–19 shall make public the cash price for such test on a public internet website of such pro- vider. ‘‘(2) CIVIL MONETARY PENALTIES.—The Secretary of Health and Human Services may impose a civil mone- tary penalty on any provider of a diagnostic test for COVID–19 that is not in compliance with paragraph (1) and has not completed a corrective action plan to comply with the requirements of such paragraph, in an amount not to exceed $300 per day that the viola- tion is ongoing.’’ STUDY OF TREATMENT OF CERTAIN CLINICS AS COVERED ENTITIES ELIGIBLE FOR PRESCRIPTION DRUG DISCOUNTS Pub. L. 102–585, title VI, § 602(b), Nov. 4, 1992, 106 Stat. 4970, directed Secretary of Health and Human Services to conduct a study of feasibility and desirability of in- cluding specified entities receiving funds from a State as covered entities eligible for limitations on prices of covered outpatient drugs under 42 U.S.C. 256b(a) and, not later than 1 year after Nov. 4, 1992, to submit a re- port to Congress on the study, including in the report a description of the entities that were the subject of the study, an analysis of the extent to which such enti- ties procured prescription drugs, and an analysis of the impact of the inclusion of such entities as covered enti- ties on the quality of care provided to and the health status of the patients of such entities. SUBPART VIII—BULK PURCHASES OF VACCINES FOR CERTAIN PROGRAMS Editorial Notes CODIFICATION Pub. L. 103–43, title XX, § 2008(i)(2)(A)(i), June 10, 1993, 107 Stat. 213, made technical amendment relating to placement of subpart VIII within part D of this sub- chapter. § 256c. Bulk purchases of vaccines for certain programs (a) Agreements for purchases (1) In general Not later than 180 days after October 27, 1992, the Secretary, acting through the Director of the Centers for Disease Control and Preven- tion and in consultation with the Adminis- trator of the Health Resources and Services Administration, shall enter into negotiations with manufacturers of vaccines for the pur- pose of establishing and maintaining agree- ments under which entities described in para- graph (2) may purchase vaccines from the manufacturers at the prices specified in the agreements. (2) Relevant entities The entities referred to in paragraph (1) are entities that provide immunizations against vaccine-preventable diseases with assistance provided under section 254b of this title. (b) Negotiation of prices In carrying out subsection (a), the Secretary shall, to the extent practicable, ensure that the prices provided for in agreements under such subsection are comparable to the prices provided for in agreements negotiated by the Secretary on behalf of grantees under section 247b(j)(1) of this title. (c) Authority of Secretary In carrying out subsection (a), the Secretary, in the discretion of the Secretary, may enter into the agreements described in such sub- section (and may decline to enter into such agreements), may modify such agreements, may extend such agreements, and may terminate such agreements. (d) Rule of construction This section may not be construed as requir- ing any State to reduce or terminate the supply of vaccines provided by the State to any of the entities described in subsection (a)(2). (July 1, 1944, ch. 373, title III, § 340C, formerly § 340B, as added Pub. L. 102–531, title III, § 305, Oct. 27, 1992, 106 Stat. 3494; renumbered § 340C, Page 443 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 256e 1 See References in Text note below. Pub. L. 103–43, title XX, § 2008(i)(2)(A)(ii), June 10, 1993, 107 Stat. 213; amended Pub. L. 104–299, § 4(a)(2), Oct. 11, 1996, 110 Stat. 3645.) Editorial Notes AMENDMENTS 1996—Subsec. (a)(2). Pub. L. 104–299 substituted ‘‘with assistance provided under section 254b of this title’’ for ‘‘under the programs established in sections 254b, 254c, 256, and 256a of this title.’’ Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104–299 effective Oct. 1, 1996, see section 5 of Pub. L. 104–299, as amended, set out as a note under section 233 of this title. § 256d. Breast and cervical cancer information (a) In general As a condition of receiving grants, cooperative agreements, or contracts under this chapter, each of the entities specified in subsection (c) shall, to the extent determined to be appro- priate by the Secretary, make available infor- mation concerning breast and cervical cancer. (b) Certain authorities In carrying out subsection (a), an entity speci- fied in subsection (c)— (1) may make the information involved available to such individuals as the entity de- termines appropriate; (2) may, as appropriate, provide information under subsection (a) on the need for self-exam- ination of the breasts and on the skills for such self-examinations; (3) shall provide information under sub- section (a) in the language and cultural con- text most appropriate to the individuals to whom the information is provided; and (4) shall refer such clients as the entities de- termine appropriate for breast and cervical cancer screening, treatment, or other appro- priate services. (c) Relevant entities The entities specified in this subsection are the following: (1) Entities receiving assistance under sec- tion 247b–7 1 of this title (relating to tuber- culosis). (2) Entities receiving assistance under sec- tion 247c of this title (relating to sexually transmitted diseases). (3) Migrant health centers receiving assist- ance under section 254b 1 of this title. (4) Community health centers receiving as- sistance under section 254c 1 of this title. (5) Entities receiving assistance under sec- tion 254b(h) of this title (relating to homeless individuals). (6) Entities receiving assistance under sec- tion 256a 1 of this title (relating to health serv- ices for residents of public housing). (7) Entities providing services with assist- ance under subchapter III–A or subchapter XVII. (8) Entities receiving assistance under sec- tion 300 of this title (relating to family plan- ning). (9) Entities receiving assistance under sub- chapter XXIV (relating to services with re- spect to acquired immune deficiency syn- drome). (10) Non-Federal entities authorized under the Indian Self-Determination Act [25 U.S.C. 5321 et seq.]. (July 1, 1944, ch. 373, title III, § 340D, as added Pub. L. 103–183, title I, § 104, Dec. 14, 1993, 107 Stat. 2230; amended Pub. L. 106–310, div. A, title XXV, § 2502(b), Oct. 17, 2000, 114 Stat. 1163; Pub. L. 107–251, title VI, § 601(a), Oct. 26, 2002, 116 Stat. 1664.) Editorial Notes REFERENCES IN TEXT Section 247b–7 of this title, referred to in subsec. (c)(1), relates to loan repayment program and not to as- sistance relating to tuberculosis. Sections 254b and 254c of this title, referred to in sub- sec. (c)(3), (4), were in the original references to sec- tions 329 and 330, meaning sections 329 and 330 of act July 1, 1944, which were omitted in the general amend- ment of subpart I (§ 254b et seq.) of this part by Pub. L. 104–299, § 2, Oct. 11, 1996, 110 Stat. 3626. Sections 2 and 3(a) of Pub. L. 104–299 enacted new sections 330 and 330A of act July 1, 1944, which are classified, respectively, to sections 254b and 254c of this title. Section 256a of this title, referred to in subsec. (c)(6), was repealed by Pub. L. 104–299, § 4(a)(3), Oct. 11, 1996, 110 Stat. 3645. The Indian Self-Determination Act, referred to in subsec. (c)(10), is title I of Pub. L. 93–638, Jan. 4, 1975, 88 Stat. 2206, which is classified principally to sub- chapter I (§ 5321 et seq.) of chapter 46 of Title 25, Indi- ans. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of Title 25 and Tables. AMENDMENTS 2002—Subsec. (c)(5). Pub. L. 107–251 substituted ‘‘254b(h)’’ for ‘‘256’’. 2000—Subsec. (c)(1). Pub. L. 106–310 substituted ‘‘sec- tion 247b–7 of this title’’ for ‘‘section 247b–6 of this title’’. Statutory Notes and Related Subsidiaries REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING, OR HOMELESS HEALTH CENTER CONSIDERED REF- ERENCE TO HEALTH CENTER Reference to community health center, migrant health center, public housing health center, or home- less health center, considered reference to health cen- ter, see section 4(c) of Pub. L. 104–299, set out as a note under section 254b of this title. SUBPART IX—SUPPORT OF GRADUATE MEDICAL EDUCATION PROGRAMS IN CHILDREN’S HOSPITALS § 256e. Program of payments to children’s hos- pitals that operate graduate medical edu- cation programs (a) Payments The Secretary shall make two payments under this section to each children’s hospital for each of fiscal years 2000 through 2005, each of fiscal years 2007 through 2011, each of fiscal years 2014 through 2018, and each of fiscal years 2019 through 2023, one for the direct expenses and the other for indirect expenses associated with oper- ating approved graduate medical residency training programs. The Secretary shall promul-