<?xml version="1.0"?>
<?xml-stylesheet type="text/xsl" href="billres.xsl"?>
<!DOCTYPE bill PUBLIC "-//US Congress//DTDs/bill.dtd//EN" "bill.dtd">
<bill bill-stage="Introduced-in-House" dms-id="H6CC4E71157A845B79B6F17E24F6D9A3D" public-private="public" key="H" bill-type="olc"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
<dublinCore>
<dc:title>116 HR 1768 IH: Lower Costs for Everyday Americans Act</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2025-03-03</dc:date>
<dc:format>text/xml</dc:format>
<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
</dublinCore>
</metadata>
<form>
<distribution-code display="yes">I</distribution-code><congress display="yes">119th CONGRESS</congress><session display="yes">1st Session</session><legis-num display="yes">H. R. 1768</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20250303">March 3, 2025</action-date><action-desc><sponsor name-id="P000034">Mr. Pallone</sponsor> introduced the following bill; which was referred to the <committee-name committee-id="HIF00">Committee on Energy and Commerce</committee-name>, and in addition to the Committees on <committee-name committee-id="HWM00">Ways and Means</committee-name>, <committee-name committee-id="HBU00">the Budget</committee-name>, <committee-name committee-id="HJU00">the Judiciary</committee-name>, and <committee-name committee-id="HED00">Education and Workforce</committee-name>, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned</action-desc></action><legis-type>A BILL</legis-type><official-title display="yes">To provide for lower costs for everyday Americans, and for other purposes.</official-title></form><legis-body id="H61459CE9085D43B183F2DF1F46F06654" style="OLC"><section id="H59FA79148EE44ED0802EE1698CFF686A" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Lower Costs for Everyday Americans Act</short-title></quote>.</text></section><section id="HDCBB4129315B4EEA8C1ABEC9CBEA2AE8"><enum>2.</enum><header>Table of contents</header><text display-inline="no-display-inline">The table of contents for this Act is as follows:</text><toc container-level="legis-body-container" quoted-block="no-quoted-block" lowest-level="section" regeneration="yes-regeneration" lowest-bolded-level="division-lowest-bolded"><toc-entry idref="H59FA79148EE44ED0802EE1698CFF686A" level="section">Sec. 1. Short title.</toc-entry><toc-entry idref="HDCBB4129315B4EEA8C1ABEC9CBEA2AE8" level="section">Sec. 2. Table of contents.</toc-entry><toc-entry idref="H5894A9B96BA6450DB3715012D71D2199" level="division">Division A—Recycling, Water, and Environment Related Provisions</toc-entry><toc-entry idref="HECADD6BC6A6E4F908CB39A5516910502" level="section">Sec. 101. Recycling and composting accountability.</toc-entry><toc-entry idref="H48F7D355ECB14C588F5A17403465414F" level="section">Sec. 102. Recycling Infrastructure and Accessibility Program.</toc-entry><toc-entry idref="H93A2B3AEC0854194BD3D830D54A2C849" level="section">Sec. 103. Drinking water infrastructure risk and resilience.</toc-entry><toc-entry idref="H11C6606E414F43E28F6D270559BC90E2" level="section">Sec. 104. Reauthorization of Diesel Emissions Reduction Act.</toc-entry><toc-entry idref="H685A2A43CDB64CB2AEA847973B303C27" level="section">Sec. 105. Nationwide Consumer and Fuel Retailer Choice Act.</toc-entry><toc-entry idref="H1774B123FEFA4A109F778F041A70C63E" level="division">Division B—Commerce</toc-entry><toc-entry idref="HD25527F16C9A40CEBC5A56DDA9ED2DC0" level="title">Title I—Youth Poisoning Prevention</toc-entry><toc-entry idref="HAB803D8D5A5F4855AD55DDE195AF065A" level="section">Sec. 101. Short title.</toc-entry><toc-entry changed="not-changed" idref="H73C22C21E4D74B778576939DE3594198" level="section">Sec. 102. Banning of products containing a high concentration of sodium nitrite.</toc-entry><toc-entry idref="H001223A32A70472B84C6DD053667F6C0" level="title">Title II—Consumer Product Safety Standard for Certain Batteries</toc-entry><toc-entry idref="H45F14149A7164181B637D0FCFD866937" level="section">Sec. 201. Consumer product safety standard for certain batteries.</toc-entry><toc-entry idref="H4E1134B9F9C84965BFF3290FF57422F0" level="title">Title III—Foreign Adversary Communications Transparency Act</toc-entry><toc-entry idref="H6AA5558515364F0EAB12E9797113A863" level="section">Sec. 301. Short title.</toc-entry><toc-entry idref="H1FA46AF688E34550A040FB3D7E9C647F" level="section">Sec. 302. List of entities holding FCC authorizations, licenses, or other grants of authority and having certain foreign ownership.</toc-entry><toc-entry idref="HBC71E4BFF9614E4C8EEFE0005A6ED892" level="title">Title IV—Promoting Resilient Supply Chains</toc-entry><toc-entry idref="HEA7F6BF1C23C4CF3BBD69C3613A0B309" level="section">Sec. 401. Short title.</toc-entry><toc-entry idref="HD7ECA5DD75C34661BA981468B579FD6B" level="section">Sec. 402. Additional responsibilities of Assistant Secretary of Commerce for Industry and Analysis.</toc-entry><toc-entry idref="HB2284A31F6FB41C8899D4083A3F53D0D" level="section">Sec. 403. Critical supply chain resilience working group.</toc-entry><toc-entry idref="HA08FCC8C8A88401B880BD7939DB8039E" level="section">Sec. 404. Department of Commerce capability assessment.</toc-entry><toc-entry idref="HBDEA6DD0DFEE40B2A5A0C822271ACB07" level="section">Sec. 405. No additional funds.</toc-entry><toc-entry idref="H26418551BE83445292AF6D449634E39D" level="section">Sec. 406. Sunset.</toc-entry><toc-entry idref="HE534C6C77A824E66AB4294583382368F" level="section">Sec. 407. Definitions.</toc-entry><toc-entry idref="HFF68D17D95D44AC69F9F9489193531F8" level="title">Title V—Deploying American Blockchains</toc-entry><toc-entry idref="H71B5949BE8A140AB8408600F55DDA2C7" level="section">Sec. 501. Short title.</toc-entry><toc-entry idref="H108206CBBADE46C5A26E2C2890B4F4CF" level="section">Sec. 502. Definitions.</toc-entry><toc-entry idref="HED5E4AFDD2624E959744EE74DE1D121C" level="section">Sec. 503. Department of Commerce leadership on blockchain.</toc-entry><toc-entry idref="H4C6EA9DF1069431A9A64EF3124B36613" level="section">Sec. 504. Reports to Congress.</toc-entry><toc-entry idref="HB609334B398148CD8F76A800C9B3C249" level="title">Title VI—FUTURE Networks Act</toc-entry><toc-entry idref="HCA531835571D40F884B2D13778CC9E37" level="section">Sec. 601. Short title.</toc-entry><toc-entry idref="H089F51F11A7D484088E98EBC7D31C31E" level="section">Sec. 602. 6G task force.</toc-entry><toc-entry idref="H5A9FCB82F5094D7288D06A2B1558B6F3" level="section">Sec. 603. Termination of Task Force.</toc-entry><toc-entry idref="HD07EB4836B9D42528736A46214BC3953" level="title">Title VII—Secure Space Act</toc-entry><toc-entry changed="not-changed" idref="HFE4EDB6891D045E381293648AA970C5E" level="section">Sec. 701. Short title.</toc-entry><toc-entry changed="not-changed" idref="H4D2B6627BFD34A2D8832BF96CF7C3B09" level="section">Sec. 702. Prohibition on grant of certain satellite licenses, United States market access, or earth station authorizations.</toc-entry><toc-entry idref="H5340C2548E604083846E73BB707A556F" level="title">Title VIII—TAKE IT DOWN Act</toc-entry><toc-entry idref="HD06247D2DF0B440EB89B681085D30312" level="section">Sec. 801. Short title.</toc-entry><toc-entry idref="H2EC69160F1074AD5B68B2CDCEA34BFE4" level="section">Sec. 802. Criminal prohibition on intentional disclosure of nonconsensual intimate visual depictions.</toc-entry><toc-entry idref="HC50CA7D89E5D4CCC965F8F42CF91CA27" level="section">Sec. 803. Notice and removal of nonconsensual intimate visual depictions.</toc-entry><toc-entry idref="H404560771A1C41AF9D32769558EA43A8" level="section">Sec. 804. Definitions.</toc-entry><toc-entry idref="HBD288E699EA9479EB343A83516492211" level="section">Sec. 805. Severability.</toc-entry><toc-entry idref="H81CB3699195941008029C8E3818EFCD0" level="title">Title IX—Rural Broadband Protection Act</toc-entry><toc-entry changed="not-changed" idref="H277E1704C2474506BA565003925E2B88" level="section">Sec. 901. Short title.</toc-entry><toc-entry changed="not-changed" idref="HFDC4FE70AB4A41CF947EBCC613FDD1EE" level="section">Sec. 902. Vetting process for prospective high-cost universal service fund applicants.</toc-entry><toc-entry idref="H3151FD29F62943148C1B17579BDE5A16" level="title">Title X—American Music Tourism</toc-entry><toc-entry changed="not-changed" idref="H3F96853B4E004B43AC51E601F9F5F93F" level="section">Sec. 1001. Short title.</toc-entry><toc-entry changed="not-changed" idref="HDCC4BB7869BB442EB890E2BC92A418C5" level="section">Sec. 1002. Responsibilities of the Assistant Secretary of Commerce for Travel and Tourism.</toc-entry><toc-entry idref="HCCF8E7608FA2499FA9841F328C6AFFF3" level="title">Title XI—Informing Consumers about Smart Devices</toc-entry><toc-entry idref="H2BC8C4AF062A481BB592F34B679C677A" level="section">Sec. 1101. Short title.</toc-entry><toc-entry idref="HBE279CD7072F40B190C4A3AF9232BED9" level="section">Sec. 1102. Required disclosure of a camera or recording capability in certain internet-connected devices.</toc-entry><toc-entry idref="H151FC74A1B424D0884BD4FE4F9F1F4BC" level="section">Sec. 1103. Enforcement by the Federal Trade Commission.</toc-entry><toc-entry idref="HB55ADC0A46B24BFF85C10F3E45E5380C" level="section">Sec. 1104. Definition of covered device.</toc-entry><toc-entry idref="H092EC9DBBC2D463EA0201FAFDEBB4119" level="section">Sec. 1105. Effective date.</toc-entry><toc-entry idref="H9CA8B99A0DA3441C9DB9BDE3931CCEAC" level="title">Title XII—Securing Semiconductor Supply Chains Act</toc-entry><toc-entry changed="not-changed" idref="H8862BB0D49D84B37AEF1F0DE12D7C88A" level="section">Sec. 1201. Short title.</toc-entry><toc-entry changed="not-changed" idref="H8F14E27660A74676BCBA030D3456072F" level="section">Sec. 1202. SelectUSA defined.</toc-entry><toc-entry changed="not-changed" idref="H9EFAD75C87F8457CB5F7CFEA87B991A9" level="section">Sec. 1203. Findings.</toc-entry><toc-entry changed="not-changed" idref="H72A8B2A5B531463194C75F383E01B489" level="section">Sec. 1204. Coordination with State-level economic development organizations.</toc-entry><toc-entry changed="not-changed" idref="HB6CBBE6221F44932B2FC5DE18E5F52CF" level="section">Sec. 1205. Report on increasing foreign direct investment in semiconductor-related manufacturing and production.</toc-entry><toc-entry changed="not-changed" idref="H47D94096E7B9475BAF80C349E362EB6C" level="section">Sec. 1206. No additional funds.</toc-entry><toc-entry idref="H874599F68A3F44F583C95DE7F6E326EE" level="title">Title XIII—Hotel Fees Transparency Act</toc-entry><toc-entry idref="H1BDF90ACEAFF4F648C2B92E04A597D55" level="section">Sec. 1301. Short title.</toc-entry><toc-entry idref="HFBEADFE9EB6845BDBAC57CDB92C4DC63" level="section">Sec. 1302. Prohibition on unfair and deceptive advertising of hotel rooms and other short-term rental prices.</toc-entry><toc-entry idref="H0A02752352904DB8A0FD92BD860D6912" level="title">Title XIV—Transparency In Charges for Key Events Ticketing</toc-entry><toc-entry idref="H9229F797C5184BEA85377A5B20D56510" level="section">Sec. 1401. Short title.</toc-entry><toc-entry idref="H0A2DA72108364ED491CBB95F2EB72CC4" level="section">Sec. 1402. All inclusive ticket price disclosure.</toc-entry><toc-entry idref="H09729C6272404086AA5312AE4E7CC733" level="section">Sec. 1403. Speculative ticketing ban.</toc-entry><toc-entry idref="HA37A8F94855347CE9E14A4726EFEDCA6" level="section">Sec. 1404. Disclosures.</toc-entry><toc-entry idref="HEDBFBA7C57974726A41D1F1DA5BE1F66" level="section">Sec. 1405. Refund requirements.</toc-entry><toc-entry idref="H58992CD8F3224378863A2D8195774A47" level="section">Sec. 1406. Report by the Federal Trade Commission on BOTS Act of 2016 enforcement.</toc-entry><toc-entry idref="H11031E49FF18434AB83E797A33AC5616" level="section">Sec. 1407. Enforcement.</toc-entry><toc-entry idref="HA4615AF04BE54CB6BDCDE25C751933C8" level="section">Sec. 1408. Definitions.</toc-entry><toc-entry idref="H868B5652787C4FC29C2CDE44AF171CB6" level="title">Title XV—ROUTERS Act</toc-entry><toc-entry idref="HFA284352225241CEB3F0EE1758F29AE4" level="section">Sec. 1501. Short title.</toc-entry><toc-entry idref="H932554FC4C3849F98D49F3061E8329AE" level="section">Sec. 1502. Study of national security risks posed by certain routers and modems.</toc-entry><toc-entry idref="HD82ACD345A0B4565834B67FDFA4B7F99" level="title">Title XVI—NTIA Reauthorization</toc-entry><toc-entry idref="H5CD66FCB877D48A8A09CF9BEB3F843D7" level="section">Sec. 1601. Short title.</toc-entry><toc-entry idref="H84EFF7EA19154DCEBD4CA4A63DB2E36D" level="section">Sec. 1602. Definitions.</toc-entry><toc-entry idref="H04486902C4B14B5E8C951E6334EC7478" level="subtitle">Subtitle A—Reauthorization</toc-entry><toc-entry idref="H8101430297124E2F804CC0D1ED1A8757" level="section">Sec. 1611. Reauthorization of the National Telecommunications and Information Administration Organization Act.</toc-entry><toc-entry idref="H40EEA3883FBA4138B3BE230B74182082" level="section">Sec. 1612. NTIA Consolidated Reporting Act.</toc-entry><toc-entry idref="H658D43605E9B4C869757D6ECE7C7E6AD" level="subtitle">Subtitle B—Office of Spectrum Management</toc-entry><toc-entry idref="H57DC79A4ACF64F98A366F05994CB7D5C" level="section">Sec. 1621. Office of Spectrum Management.</toc-entry><toc-entry idref="H102361ACF3994DF19B9D8BCCDAEBD6B5" level="subtitle">Subtitle C—Office of International Affairs</toc-entry><toc-entry idref="H08A3935A3EEE4A28B968E2E66174AA5C" level="section">Sec. 1631. Office of International Affairs.</toc-entry><toc-entry idref="HF3DF5B5717334E40926B64158F81A33F" level="division">Division C—Health</toc-entry><toc-entry idref="H40563B358FB34D019928DE42DEF4AB6D" level="title">Title I—Medicaid</toc-entry><toc-entry idref="H3892D90A0E134D918D1896E368345170" level="section">Sec. 101. Streamlined enrollment process for eligible out-of-state providers under Medicaid and CHIP.</toc-entry><toc-entry idref="H908A95F960614496830FA5C375C50105" level="section">Sec. 102. Making certain adjustments to coverage of home or community-based services under Medicaid.</toc-entry><toc-entry idref="H162F7BF2848D425C8361F2BA0E5006BA" level="section">Sec. 103. Removing certain age restrictions on Medicaid eligibility for working adults with disabilities.</toc-entry><toc-entry idref="HE971AE3FB17548949FA576D7BDF31930" level="section">Sec. 104. Medicaid State plan requirement for determining residency and coverage for military families.</toc-entry><toc-entry idref="H1996B65D78E54EA29CF28A35ED72E65C" level="section">Sec. 105. Ensuring the reliability of address information provided under the Medicaid program.</toc-entry><toc-entry idref="HC2038BC70CA34370B436E3017A8B3218" level="section">Sec. 106. Codifying certain Medicaid provider screening requirements related to deceased providers.</toc-entry><toc-entry idref="H7C0A467CED0540FFBCC8087FE27F979A" level="section">Sec. 107. Modifying certain State requirements for ensuring deceased individuals do not remain enrolled.</toc-entry><toc-entry idref="H4475FB6F73C341A88FB5583D088E3772" level="section">Sec. 108. One-year delay of Medicaid and CHIP requirements for health screenings, referrals, and case management services for eligible juveniles in public institutions; State interim work plans.</toc-entry><toc-entry idref="HD059307F14114C4C847DF42C2B5B4ABC" level="section">Sec. 109. State studies and HHS report on costs of providing maternity, labor, and delivery services.</toc-entry><toc-entry idref="HAD4FFB35D0194180B25838D9C3BAF8B3" level="section">Sec. 110. Modifying certain disproportionate share hospital allotments.</toc-entry><toc-entry idref="HB338874B817C469BA85072097B0D2E5F" level="section">Sec. 111. Modifying certain limitations on disproportionate share hospital payment adjustments under the Medicaid program.</toc-entry><toc-entry idref="HF5DC0E3F7E2B4EF683B75CEF41E4AF3A" level="section">Sec. 112. Ensuring accurate payments to pharmacies under Medicaid.</toc-entry><toc-entry idref="H68D16CA7A1C3454DAB3B9E85C02A786E" level="section">Sec. 113. Preventing the use of abusive spread pricing in Medicaid.</toc-entry><toc-entry idref="H3935AA91AC524702AA8A92F40E8B4108" level="title">Title II—Medicare</toc-entry><toc-entry idref="HA2106815578B436B9A23AAC08EDA44E8" level="section">Sec. 201. Extension of increased inpatient hospital payment adjustment for certain low-volume hospitals.</toc-entry><toc-entry idref="H3D8F75C872814B9789D08B456243285A" level="section">Sec. 202. Extension of the Medicare-dependent hospital (MDH) program.</toc-entry><toc-entry idref="H8DC1A346224A473D9F33190D23268732" level="section">Sec. 203. Extension of add-on payments for ambulance services.</toc-entry><toc-entry idref="H103DE72F0E404893BC35560542266A98" level="section">Sec. 204. Extending incentive payments for participation in eligible alternative payment models.</toc-entry><toc-entry idref="H5506069197414434AFEE9E4F9749F0A4" level="section">Sec. 205. Temporary payment increase under the Medicare physician fee schedule to account for exceptional circumstances.</toc-entry><toc-entry idref="H1F4A5338AC0B46478A5A3D7B93EEB142" level="section">Sec. 206. Extension of funding for quality measure endorsement, input, and selection.</toc-entry><toc-entry idref="HF0549E3C1E704A7FBF6AF79B5C3A6318" level="section">Sec. 207. Extension of funding outreach and assistance for low-income programs.</toc-entry><toc-entry idref="H234687799F1540F481264BECAE2D4D66" level="section">Sec. 208. Extension of the work geographic index floor.</toc-entry><toc-entry idref="HA9EA81521CDD4C78A90FC6200C8E915F" level="section">Sec. 209. Extension of certain telehealth flexibilities.</toc-entry><toc-entry idref="H39E0CA975ECC4A2EA4D70A333A7E45C5" level="section">Sec. 210. Requiring modifier for use of telehealth to conduct face-to-face encounter prior to recertification of eligibility for hospice care.</toc-entry><toc-entry idref="HCC9B60C45469445C8FF5EE3B71F4C552" level="section">Sec. 211. Extending acute hospital care at home waiver flexibilities.</toc-entry><toc-entry idref="H4F34F4E2C43F4F2C881087FB5D5F0078" level="section">Sec. 212. Enhancing certain program integrity requirements for DME under Medicare.</toc-entry><toc-entry idref="HB3623D07A75E472799380F87BFB51408" level="section">Sec. 213. Guidance on furnishing services via telehealth to individuals with limited English proficiency.</toc-entry><toc-entry idref="HAF33887A75D44AA8AEAA8FA43B4F9263" level="section">Sec. 214. In-home cardiopulmonary rehabilitation flexibilities.</toc-entry><toc-entry idref="HAFDA9A06CBC142A29ED1D77BDED1AA96" level="section">Sec. 215. Inclusion of virtual diabetes prevention program suppliers in MDPP Expanded Model.</toc-entry><toc-entry idref="H5BB54C35666040A4951E67BF580F00C3" level="section">Sec. 216. Medication-induced movement disorder outreach and education.</toc-entry><toc-entry idref="H50C1A5BF09DF4FD683EB94F6CD890F94" level="section">Sec. 217. Report on wearable medical devices.</toc-entry><toc-entry idref="H98BBF63A9CDF40029FBFD0445DBBB63A" level="section">Sec. 218. Extension of temporary inclusion of authorized oral antiviral drugs as covered part D drugs.</toc-entry><toc-entry idref="H2811D91DBFD14E5690700F86C66C5B1B" level="section">Sec. 219. Extension of adjustment to calculation of hospice cap amount.</toc-entry><toc-entry idref="H072728C94404481DB043F074751F982B" level="section">Sec. 220. Multiyear contracting authority for MedPAC and MACPAC.</toc-entry><toc-entry idref="HD9294B91DEF7421CB74DCD45ABFBC1AF" level="section">Sec. 221. Contracting parity for MedPAC and MACPAC.</toc-entry><toc-entry idref="HF7338FDDF8544438B9EF61E0A733C588" level="section">Sec. 222. Adjustments to Medicare part D cost-sharing reductions for low-income individuals.</toc-entry><toc-entry idref="H8FEECB3D10294FA9BCF0BED9F87FA3F4" level="section">Sec. 223. Requiring Enhanced and Accurate Lists of (REAL) Health Providers Act.</toc-entry><toc-entry idref="HE4D119B4212A4EC0ADC0BCE4EB5D1E1D" level="section">Sec. 224. Medicare coverage of multi-cancer early detection screening tests.</toc-entry><toc-entry idref="HF1FE8B7075134426AF09EE965BFDB3EC" level="section">Sec. 225. Medicare coverage of external infusion pumps and non-self-administrable home infusion drugs.</toc-entry><toc-entry idref="HDA167F085BF445919024D77AD32D387B" level="section">Sec. 226. Assuring pharmacy access and choice for Medicare beneficiaries.</toc-entry><toc-entry idref="H4077827B2077471081A309E97D27F6DF" level="section">Sec. 227. Modernizing and Ensuring PBM Accountability.</toc-entry><toc-entry idref="HA7BB0193F321438681A5F2B1584CCB25" level="section">Sec. 228. Requiring a separate identification number and an attestation for each off-campus outpatient department of a provider.</toc-entry><toc-entry idref="H570DEAC61540462EB8E57E7F259FB4B2" level="section">Sec. 229. Medicare sequestration.</toc-entry><toc-entry idref="H30C4F27C4C454D109F079D3BAD8EEA49" level="title">Title III—Other matters</toc-entry><toc-entry idref="H7C506C7A693C4F1AA9C3C6CB53C8718D" level="section">Sec. 301. Sexual risk avoidance education extension.</toc-entry><toc-entry idref="H5D739B7348B34B1A8B146A958E406F5A" level="section">Sec. 302. Personal responsibility education extension.</toc-entry><toc-entry idref="H695DB300FC954238867DE2E2E27CA80E" level="section">Sec. 303. Extension of funding for family-to-family health information centers.</toc-entry><toc-entry idref="H34C6A2B454A6476F8F0395B264275D6D" level="title">Title IV—Public health extenders</toc-entry><toc-entry idref="H76BF759FB61F4F97930791EFB0AF7F93" level="subtitle">Subtitle A—Extensions</toc-entry><toc-entry idref="HDC2F2034040E4E1F9F487313A68FB7F2" level="section">Sec. 401. Extension for community health centers, National Health Service Corps, and teaching health centers that operate GME programs.</toc-entry><toc-entry idref="H40FAE07971544FAD9921EC523106A7A7" level="section">Sec. 402. Extension of special diabetes programs.</toc-entry><toc-entry idref="H72E9F6277EB549068FDB911A847348A6" level="subtitle">Subtitle B—World Trade Center Health Program</toc-entry><toc-entry idref="H7CBB7A6E0A784133A77D7D56D854AA00" level="section">Sec. 411. 9/11 responder and survivor health funding corrections.</toc-entry><toc-entry idref="H1211338397CA458E8C259988AC71C2D1" level="title">Title V—SUPPORT Act Reauthorization</toc-entry><toc-entry idref="HF6A5B709598F4ED2885CDDC3D69A5FDA" level="section">Sec. 501. Short title.</toc-entry><toc-entry idref="H772A457722E1464189900965EB95A79D" level="subtitle">Subtitle A—Prevention</toc-entry><toc-entry idref="H91B761EAD4274B54A1E559C25F15BCC2" level="section">Sec. 511. Prenatal and postnatal health.</toc-entry><toc-entry idref="HF493DF7918224450AD977FFDBDB1C4EC" level="section">Sec. 512. Monitoring and education regarding infections associated with illicit drug use and other risk factors.</toc-entry><toc-entry idref="H2CC393411220484A99F781085F3E7DF9" level="section">Sec. 513. Preventing overdoses of controlled substances.</toc-entry><toc-entry idref="HF24123FEECDD4399934B3EBE89662C57" level="section">Sec. 514. Support for individuals and families impacted by fetal alcohol spectrum disorder.</toc-entry><toc-entry idref="HE5C66D1E87914357A0858C19CEA29049" level="section">Sec. 515. Promoting state choice in PDMP systems.</toc-entry><toc-entry idref="H16E0CB23DC024C4988E5B90F2F926E8E" level="section">Sec. 516. First responder training program.</toc-entry><toc-entry idref="H7337B71406FC45CDBB864570D7C7E730" level="section">Sec. 517. Donald J. Cohen National Child Traumatic Stress Initiative.</toc-entry><toc-entry idref="H5C574E6BFF504FAF8E029FF32066047A" level="section">Sec. 518. Protecting suicide prevention lifeline from cybersecurity incidents.</toc-entry><toc-entry idref="H7D1165B9667946E896F408C9AE969D3A" level="section">Sec. 519. Bruce’s law.</toc-entry><toc-entry idref="H9A2D84E2981B481A821EE2CD5F2B238C" level="section">Sec. 520. Guidance on at-home drug disposal systems.</toc-entry><toc-entry idref="H880A624F71A344BDBAA3D77868F64B40" level="section">Sec. 521. Assessment of opioid drugs and actions.</toc-entry><toc-entry idref="HFB0530157BD3490A9D850314C2660789" level="section">Sec. 522. Grant program for State and Tribal response to opioid use disorders.</toc-entry><toc-entry idref="H8905C906D0B94DD0A4062EBC0755BE30" level="subtitle">Subtitle B—Treatment</toc-entry><toc-entry idref="HBF43094F360042149DF4D7BDA5F3C9BB" level="section">Sec. 531. Residential treatment program for pregnant and postpartum women.</toc-entry><toc-entry idref="HECA6B841C68B43CF8C0E4ED531EB3961" level="section">Sec. 532. Improving access to addiction medicine providers.</toc-entry><toc-entry idref="HC17D20C3CC694785AAAED23BFE781DDB" level="section">Sec. 533. Mental and behavioral health education and training grants.</toc-entry><toc-entry idref="H01452F982E5E4BDD96F73E4B0906F489" level="section">Sec. 534. Loan repayment program for substance use disorder treatment workforce.</toc-entry><toc-entry idref="HD4780649C3C24902A18B8E0390C57E13" level="section">Sec. 535. Development and dissemination of model training programs for substance use disorder patient records.</toc-entry><toc-entry idref="HD7867945C0774D33962295CAFAB949D6" level="section">Sec. 536. Task force on best practices for trauma-informed identification, referral, and support.</toc-entry><toc-entry idref="H489613803AC9479C9533D463A0A0F8CF" level="section">Sec. 537. Grants to enhance access to substance use disorder treatment.</toc-entry><toc-entry idref="HE3173023824B4030B651C945BC1E8EE1" level="section">Sec. 538. State guidance related to individuals with serious mental illness and children with serious emotional disturbance.</toc-entry><toc-entry idref="HC461A035878C438B922DB396F1875257" level="section">Sec. 539. Reviewing the scheduling of approved products containing a combination of buprenorphine and naloxone.</toc-entry><toc-entry idref="HE8CEF0550F284E96B0F35DACE6128BFC" level="subtitle">Subtitle C—Recovery</toc-entry><toc-entry idref="HF04738CE0D854C4998EFD578ACB011D5" level="section">Sec. 541. Building communities of recovery.</toc-entry><toc-entry idref="H8160987F3D404B1B8AACC78D1B9B65C5" level="section">Sec. 542. Peer support technical assistance center.</toc-entry><toc-entry idref="H6DFD966BDD1B4EB3812B51D6ED508EB6" level="section">Sec. 543. Comprehensive opioid recovery centers.</toc-entry><toc-entry idref="HDAC3096101B54A1389F8314BD7F210E7" level="section">Sec. 544. Youth prevention and recovery.</toc-entry><toc-entry idref="HE12B4F0E43D74E9B94AC8F927E1D52BB" level="section">Sec. 545. CAREER Act.</toc-entry><toc-entry idref="HCA25DEC9E200453088A0AA1EBBA02092" level="section">Sec. 546. Addressing economic and workforce impacts of the opioid crisis.</toc-entry><toc-entry idref="HA90D2D930039477DB5EDBF73AB506DD1" level="subtitle">Subtitle D—Miscellaneous matters</toc-entry><toc-entry idref="H69DF392E13FB4ACFB26280C916720D6F" level="section">Sec. 551. Delivery of a controlled substance by a pharmacy to a prescribing practitioner.</toc-entry><toc-entry idref="HEA2C615CF0644AF2BA0E4A8C2F5039AE" level="section">Sec. 552. Technical correction on controlled substances dispensing.</toc-entry><toc-entry idref="H1AD8EE7914CD4A048B9A6D5FD3A74781" level="section">Sec. 553. Required training for prescribers of controlled substances.</toc-entry><toc-entry idref="H9D9B590F9A594D219E1066152D95E0AE" level="section">Sec. 554. Extension of temporary order for fentanyl-related substances.</toc-entry><toc-entry idref="HBF5129531056445AACB9851334A369F5" level="title">Title VI—Pandemic and All-Hazards Preparedness and Response</toc-entry><toc-entry idref="H838A2E6E1E1D4214A8EA3D594AFB17EF" level="section">Sec. 601. Short title.</toc-entry><toc-entry idref="HFD4FA6ABE3344AFD84A5A6077889A436" level="subtitle">Subtitle A—State and local readiness and response</toc-entry><toc-entry idref="H23C4A5B30C3048BAA4CCD13527F7AA63" level="section">Sec. 611. Temporary reassignment of State and local personnel during a public health emergency.</toc-entry><toc-entry idref="H37C2671ABA914199913E7D5533BA75DC" level="section">Sec. 612. Public Health Emergency Preparedness program.</toc-entry><toc-entry idref="H235B5E1580EC4179A3A631DFE9EA2374" level="section">Sec. 613. Hospital Preparedness Program.</toc-entry><toc-entry idref="HDA2E56CF0ABC468DAFE6F978016A22EF" level="section">Sec. 614. Facilities and capacities of the Centers for Disease Control and Prevention to combat public health security threats.</toc-entry><toc-entry idref="HFBAE642E81E144ADA59103B97257C055" level="section">Sec. 615. Pilot program to support State medical stockpiles.</toc-entry><toc-entry idref="H2B8A6D3BA39C446E8B985E6B660D94EC" level="section">Sec. 616. Enhancing domestic wastewater surveillance for pathogen detection.</toc-entry><toc-entry idref="HD3BFEBB461754E0E902E002860907FCF" level="section">Sec. 617. Reauthorization of Mosquito Abatement for Safety and Health program.</toc-entry><toc-entry idref="H175945C3837548079E6252572ED1E462" level="subtitle">Subtitle B—Federal planning and coordination</toc-entry><toc-entry idref="H8E1FCF28DA2C463989A6229093CC5196" level="section">Sec. 621. All-Hazards Emergency Preparedness and Response.</toc-entry><toc-entry idref="HB90CB75F133048FCA56D4CE10C27D5EC" level="section">Sec. 622. National Health Security Strategy.</toc-entry><toc-entry idref="H21AA8EB604254034921C114FD4CC528B" level="section">Sec. 623. Improving development and distribution of diagnostic tests.</toc-entry><toc-entry idref="H2CFAE192BEF4486FB0394CCA6F97C57B" level="section">Sec. 624. Combating antimicrobial resistance.</toc-entry><toc-entry idref="H9A02D5B481FE4747ADAE0C5A305D8F9B" level="section">Sec. 625. Strategic National Stockpile and material threats.</toc-entry><toc-entry idref="H32392C29035F4C7291027B2762D0E172" level="section">Sec. 626. Medical countermeasures for viral threats with pandemic potential.</toc-entry><toc-entry idref="H70D4D6F217004E2692EDE0CC568DC2D4" level="section">Sec. 627. Public Health Emergency Medical Countermeasures Enterprise.</toc-entry><toc-entry idref="HBBE28E30510A43FDB4D9ACFDF89F98FD" level="section">Sec. 628. Fellowship and training programs.</toc-entry><toc-entry idref="HC1272D864856414D8A6EBACFD2A877F1" level="section">Sec. 629. Regional biocontainment research laboratories.</toc-entry><toc-entry idref="H9D3CDD81E9F4490E8817D50E5883B2C3" level="section">Sec. 629A. Limitation related to countries of concern conducting certain research.</toc-entry><toc-entry idref="H884253C6C5EA4C76888FC5929A55A624" level="subtitle">Subtitle C—Addressing the needs of all individuals</toc-entry><toc-entry idref="H178F3DDB8CDF4F5E99F86C11F4F767F6" level="section">Sec. 631. Improving access to certain programs.</toc-entry><toc-entry idref="H94CDEDA18B744201807124AF4F47793B" level="section">Sec. 632. Supporting at-risk individuals during emergency responses.</toc-entry><toc-entry idref="H731924506FF54B639C07DF29D5482E17" level="section">Sec. 633. National advisory committees.</toc-entry><toc-entry idref="HF0DAFF89F2CB45798B4610871D793320" level="section">Sec. 634. National Academies study on prizes.</toc-entry><toc-entry idref="HF4A66DED74A94278AE38967E66D5AA11" level="subtitle">Subtitle D—Additional reauthorizations</toc-entry><toc-entry idref="HFDADEAE9569A423699A7121AB4C00430" level="section">Sec. 641. Medical countermeasure priority review voucher.</toc-entry><toc-entry idref="H3420B89A5CE64C6B9AF9092EEB5D9ACA" level="section">Sec. 642. Epidemic Intelligence Service.</toc-entry><toc-entry idref="HD736404DDD5C445FB7119B0FE11523DD" level="section">Sec. 643. Monitoring and distribution of certain medical countermeasures.</toc-entry><toc-entry idref="H8265580EA16A45CE83D6526D111A4E24" level="section">Sec. 644. Regional health care emergency preparedness and response systems.</toc-entry><toc-entry idref="H8AA277C7827645BB96560F7733AFC9B2" level="section">Sec. 645. Emergency system for advance registration of volunteer health professionals.</toc-entry><toc-entry idref="H83CEB6A1FD184D21A4870A8B3B014059" level="section">Sec. 646. Ensuring collaboration and coordination in medical countermeasure development.</toc-entry><toc-entry idref="HBD70203012404CDCA70C0C6314A06DBD" level="section">Sec. 647. Military and civilian partnership for trauma readiness.</toc-entry><toc-entry idref="H1BA195219A3844B0B7D1306309F44176" level="section">Sec. 648. National Disaster Medical System.</toc-entry><toc-entry idref="H846C4BB76C9F47109CA16EF93D5E4CFC" level="section">Sec. 649. Volunteer Medical Reserve Corps.</toc-entry><toc-entry idref="HB923CE179785494EB67D11686B74B528" level="section">Sec. 650. Epidemiology-laboratory capacity.</toc-entry><toc-entry idref="HA8813E0D884B45D0B13364A5075DDF7B" level="title">Title VII—Public Health Programs</toc-entry><toc-entry idref="HD439FEB82A81488DB6CA605264DC1C88" level="section">Sec. 701. Action for dental health.</toc-entry><toc-entry idref="H222475A60E834D37966D56DBA45F5483" level="section">Sec. 702. PREEMIE.</toc-entry><toc-entry idref="H8960FB0DECC849A2A4F36034B3638DF8" level="section">Sec. 703. Preventing maternal deaths.</toc-entry><toc-entry idref="H4341868CB9B7434BBEE3E2484B27B85A" level="section">Sec. 704. Sickle cell disease prevention and treatment.</toc-entry><toc-entry idref="H16DA0106C57F4529889DB8AB43F447E0" level="section">Sec. 705. Traumatic brain injuries.</toc-entry><toc-entry idref="H10FF4783D8A84EEE81A5ED0BAF06D268" level="section">Sec. 706. Lifespan respite care.</toc-entry><toc-entry idref="HF61226C6354C463FA3A7CA1B1C701C4E" level="section">Sec. 707. Dr. Lorna Breen health care provider protection.</toc-entry><toc-entry idref="H4503103C0E05445FA76A2F6D597497F3" level="section">Sec. 708. Conforming amendment to Internal Revenue Code of 1986.</toc-entry><toc-entry idref="H19A48980167548618F08FC0A61BD8B86" level="section">Sec. 709. SCREENS for Cancer.</toc-entry><toc-entry idref="H62BAF318FEA94BA5AC99939E0544BB75" level="section">Sec. 710. DeOndra Dixon INCLUDE Project.</toc-entry><toc-entry idref="H26C7484E91FE468A848486BAF05D3898" level="section">Sec. 711. IMPROVE Initiative.</toc-entry><toc-entry idref="HDCFFAB230FA04A798E8263BB02EB758B" level="section">Sec. 712. Organ Procurement and Transplantation Network.</toc-entry><toc-entry idref="H2E4ED32FB08F42C78279676D1752999D" level="section">Sec. 713. Honor Our Living Donors.</toc-entry><toc-entry idref="HAC3C8467B1F94155AA4FB2A38EA0D2FE" level="section">Sec. 714. Program for pediatric studies of drugs.</toc-entry><toc-entry idref="HD207A985FEE649FDB9441D5DEE17053F" level="title">Title VIII—Food and Drug Administration</toc-entry><toc-entry idref="HD5D53AF4D3054A0D825BA0A3F6894449" level="subtitle">Subtitle A—Give Kids a Chance </toc-entry><toc-entry idref="H9FF0ECF4725640E487457031E9527984" level="section">Sec. 801. Research into pediatric uses of drugs; additional authorities of Food and Drug Administration regarding molecularly targeted cancer drugs.</toc-entry><toc-entry idref="HFAC7CD4051A9455BA17DBBB350DCE8F3" level="section">Sec. 802. Ensuring completion of pediatric study requirements.</toc-entry><toc-entry idref="HC937B1B9992A4500985EB08689C628BC" level="section">Sec. 803. FDA report on PREA enforcement.</toc-entry><toc-entry idref="HF84A92B32F864E98AFE039AA97606418" level="section">Sec. 804. Extension of authority to issue priority review vouchers to encourage treatments for rare pediatric diseases.</toc-entry><toc-entry idref="H22DB8B0B03D74F96AB7688B63ED536C7" level="section">Sec. 805. Limitations on exclusive approval or licensure of orphan drugs.</toc-entry><toc-entry idref="HD00FC2685EE744F5AD90485FDD3EA5D0" level="subtitle">Subtitle B—United States-Abraham Accords Cooperation and Security</toc-entry><toc-entry idref="H1B22A1977A4240538AEB2DC065AD45EA" level="section">Sec. 811. Establishment of Abraham Accords Office within Food and Drug Administration.</toc-entry><toc-entry idref="HD287EE8C303F40EE96D11AF4DE0AC86D" level="title">Title IX—Lowering prescription drug costs</toc-entry><toc-entry idref="H89EE0D52148F466A964B7E49C3B1FE6B" level="section">Sec. 901. Oversight of pharmacy benefit management services.</toc-entry><toc-entry idref="H7C7A2EB5182A410CA55B2746CDBC50E7" level="section">Sec. 902. Full rebate pass through to plan; exception for innocent plan fiduciaries.</toc-entry><toc-entry changed="not-changed" idref="H3B1D19808DFC4528BA3A8406523F4ECB" level="section">Sec. 903. Increasing transparency in generic drug applications.</toc-entry><toc-entry changed="not-changed" idref="HED9FECB6F70C48878E599E0D7E53D4EF" level="section">Sec. 904. Title 35 amendments.</toc-entry><toc-entry idref="HEEA0F976F62A43C19640CB36069FB65A" level="title">Title X—Miscellaneous</toc-entry><toc-entry idref="H499E0FB39D6E4DFBAE0D2A154A15E210" level="section">Sec. 1001. Two-year extension of safe harbor for absence of deductible for telehealth.</toc-entry></toc></section><division id="H5894A9B96BA6450DB3715012D71D2199"><enum>A</enum><header>Recycling, Water, and Environment Related Provisions</header><section id="HECADD6BC6A6E4F908CB39A5516910502"><enum>101.</enum><header>Recycling and composting accountability</header><subsection commented="no" display-inline="no-display-inline" id="H10F405F8BEB440D3B741327B1BA78D48"><enum>(a)</enum><header display-inline="yes-display-inline">Short title</header><text>This section may be cited as the <quote><short-title>Recycling and Composting Accountability Act</short-title></quote>.</text></subsection><subsection id="H13DF7B07DFCC4EAE85758A7CEC34ECC8"><enum>(b)</enum><header>Definitions</header><paragraph id="HAB5E3F44F1BD4CD482C7355117FC538C"><enum>(1)</enum><header>In general</header><text>In this section:</text><subparagraph id="H68EBD7A72A9C4128ACB99B99F58BD901"><enum>(A)</enum><header>Administrator</header><text>The term <term>Administrator</term> means the Administrator of the Environmental Protection Agency.</text></subparagraph><subparagraph id="H1C8B713202064272ABD3E369F28CFD6B"><enum>(B)</enum><header>Compost</header><text>The term <term>compost</term> means a product that—</text><clause id="H7F43F447AF8C4AC88CA46BE774E89417"><enum>(i)</enum><text>is manufactured through the controlled aerobic, biological decomposition of biodegradable materials;</text></clause><clause id="HA5D4CDABF0104E7B843327179FC3BE7B"><enum>(ii)</enum><text>has been subjected to medium and high temperature organisms, which—</text><subclause id="H87FF69EC87A0446A80FA35BC360FB92C"><enum>(I)</enum><text>significantly reduce the viability of pathogens and weed seeds; and</text></subclause><subclause id="H44CE1B045F024148BB313EA0B07C340B"><enum>(II)</enum><text>stabilize carbon in the product such that the product is beneficial to plant growth; and</text></subclause></clause><clause id="HB00DF9DEB0874B8AB2C05CFC315FDE6A"><enum>(iii)</enum><text>is typically used as a soil amendment, but may also contribute plant nutrients.</text></clause></subparagraph><subparagraph id="H6BD35C330E9F43BB977C7833084CD418"><enum>(C)</enum><header>Compostable material</header><text>The term <term>compostable material</term> means material that is a feedstock for creating compost, including—</text><clause id="HEB50E30C2AFB4BB29F2D1BC6B70F2D11"><enum>(i)</enum><text>wood;</text></clause><clause id="H4DDE623FC7B34EB1B1BE83BCAC0F8698"><enum>(ii)</enum><text>agricultural crops;</text></clause><clause id="HE2E95B5477E74EC5B9381487E8786F9A"><enum>(iii)</enum><text>paper, such as cardboard and other paper products;</text></clause><clause id="HBCEE14D2B3854A018883B01BBDAC75F5"><enum>(iv)</enum><text>certified compostable products associated with organic waste;</text></clause><clause id="HB117D79376EB4DAAAF67117B8C5A7D92"><enum>(v)</enum><text>other organic plant material;</text></clause><clause id="HC6A30F2825D64B05A8846332D3552401"><enum>(vi)</enum><text>organic waste, including food waste and yard waste; and</text></clause><clause id="HF62E61FD2CA1495CB948FB6FF62329BB"><enum>(vii)</enum><text>such other material that is composed of biomass that can be continually replenished or renewed, as determined by the Administrator.</text></clause></subparagraph><subparagraph id="H92AD28BBD94C4D228C447D40A8C1085D"><enum>(D)</enum><header>Indian tribe</header><text>The term <term>Indian Tribe</term> has the meaning given the term in section 4 of the Indian Self-Determination and Education Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/25/5304">25 U.S.C. 5304</external-xref>).</text></subparagraph><subparagraph id="H0D34956E51954ECFBE9EF53F37DE2F85"><enum>(E)</enum><header>Recyclable material</header><text>The term <term>recyclable material</term> means a material that is obsolete, previously used, off-specification, surplus, or incidentally produced for processing into a specification-grade commodity for which a reuse market currently exists or is being developed.</text></subparagraph><subparagraph id="H02FBA67EC73E42D194FAE519DC6BE37F"><enum>(F)</enum><header>Recycling</header><text>The term <term>recycling</term> means the series of activities—</text><clause id="H7814D901584048B9AB8535631AFFBDF4"><enum>(i)</enum><text>during which recyclable materials are processed into specification-grade commodities and consumed as raw-material feedstock, in lieu of virgin materials, in the manufacturing of new products;</text></clause><clause id="H6471AE2D29814D77B5AF0BD5C10B0BB3"><enum>(ii)</enum><text>that may, with regard to recyclable materials and prior to the activities described in clause (i), include sorting, collection, processing, and brokering; and</text></clause><clause id="H4F135A43550642E49ED3ECAEDE43C590"><enum>(iii)</enum><text>that result, subsequent to processing described in clause (i), in consumption by a materials manufacturer, including for the manufacturing of new products.</text></clause></subparagraph><subparagraph id="HA7DD33FA3F064062A20B5F1D5254C5BE"><enum>(G)</enum><header>State</header><text>The term <term>State</term> has the meaning given the term in section 1004 of the Solid Waste Disposal Act (<external-xref legal-doc="usc" parsable-cite="usc/42/6903">42 U.S.C. 6903</external-xref>).</text></subparagraph></paragraph><paragraph id="HCA1A477FF5284243804BF47B5F3EE7C0"><enum>(2)</enum><header>Definition of processing</header><text>In subparagraphs (E) and (F) of paragraph (1), the term <term>processing</term> means any mechanical, manual, or other method that—</text><subparagraph id="HE8D0CEA38F4C4152AAE3BA787C2554D9"><enum>(A)</enum><text>transforms a recyclable material into a specification-grade commodity; and</text></subparagraph><subparagraph id="H87CE7F8D85EF42468E4FA442B3C76F17"><enum>(B)</enum><text>may occur in multiple steps, with different phases, including sorting, occurring at different locations.</text></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HB6297C9AEF0B43AEAC22D9A587EECC74"><enum>(c)</enum><header>Reports on composting and recycling infrastructure capabilities</header><paragraph commented="no" display-inline="no-display-inline" id="H6A533FF6AE7841F9A16B9C7F3684EC96"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Subtitle D of the Solid Waste Disposal Act (<external-xref legal-doc="usc" parsable-cite="usc/42/6941">42 U.S.C. 6941 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HDF7340541FE84725B91DCB2094429F3C"><section id="H560DD5A497884EF7A326018611614768"><enum>4011.</enum><header>Reports on composting and recycling infrastructure capabilities</header><subsection commented="no" display-inline="no-display-inline" id="HE8CC7284156C467FBC23CC9FE0D35743"><enum>(a)</enum><header display-inline="yes-display-inline">Definitions</header><text>In this section:</text><paragraph commented="no" display-inline="no-display-inline" id="HEDA0669E147040BFA93F5C9E9FBEA943"><enum>(1)</enum><header>Recycling and Composting Accountability Act terms</header><text>The terms <term>compost</term>, <term>compostable material</term>, <term>recyclable material</term>, and <term>recycling</term> have the meanings given the terms in subsection (b) of the <short-title>Recycling and Composting Accountability Act</short-title>.</text></paragraph><paragraph id="H1AC24A62401441E9A999DCC5367ECF02" commented="no" display-inline="no-display-inline"><enum>(2)</enum><header>Composting facility</header><text>The term <term>composting facility</term> means a location, structure, or device that transforms compostable materials into compost. </text></paragraph><paragraph id="H75AD7B7329FE4AB49801600BBBB68F11"><enum>(3)</enum><header>Indian tribe</header><text>The term <term>Indian Tribe</term> has the meaning given the term in section 4 of the Indian Self-Determination and Education Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/25/5304">25 U.S.C. 5304</external-xref>). </text></paragraph><paragraph id="H9E092EB128D04920ACC96570E53980BA"><enum>(4)</enum><header>Materials recovery facility</header><subparagraph id="HF54F8DC15BA447BA98DA7D968C58D64C"><enum>(A)</enum><header>In general</header><text>The term <term>materials recovery facility</term> means a dedicated facility where primarily residential recyclable materials, which are diverted from disposal by the generator and collected separately from municipal solid waste, are mechanically or manually sorted into commodities for further processing into specification-grade commodities for sale to end users.</text></subparagraph><subparagraph id="HAFAB90C3FEB84FE0891C8F2F081E676A"><enum>(B)</enum><header>Exclusion</header><text>The term <term>materials recovery facility</term> does not include a solid waste management facility that may process municipal solid waste to remove recyclable materials.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H441D30A6953344F2A1E5A5452DE7E178"><enum>(C)</enum><header>Definition of processing</header><text>For purposes of this paragraph, the term <term>processing</term> has the meaning given the term in subsection (b)(2) of the <short-title>Recycling and Composting Accountability Act</short-title>.</text></subparagraph></paragraph></subsection><subsection id="H8A37A3F5B39A4C4CBC28595150EB10F2"><enum>(b)</enum><header>Report</header><paragraph commented="no" display-inline="no-display-inline" id="H3DC03D0914BE4E1FBA3E7CECA3A56439"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Administrator shall request information and data from, collaborate with, or contract with, as necessary and appropriate, States, units of local government, and Indian Tribes, for the provision, preparation, and publication of a report, or to expand work under the National Recycling Strategy to include information and data, on compostable materials and efforts to reduce contamination rates for recycling, including—</text><subparagraph id="HBD5F56747A4B49DFB1CF3DA978216D9E"><enum>(A)</enum><text>an evaluation of existing Federal, State, and local laws that may present barriers to implementation of composting strategies;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8C72C5C7F3C34040BE3B55C8F7800A92"><enum>(B)</enum><text display-inline="yes-display-inline">a description and evaluation of composting infrastructure and programs within States, units of local government, and Indian Tribes;</text></subparagraph><subparagraph id="H10273D030F9F431FAE4B8C1CA799D2C7"><enum>(C)</enum><text>an estimate of the costs and approximate land needed to expand composting programs; and</text></subparagraph><subparagraph id="H13092F8A4E1D434AB73C102929F1BF4B"><enum>(D)</enum><text>a review of the practices of manufacturers and companies that are moving to using compostable packaging and food service ware for the purpose of making the composting process the end-of-life use of those products.</text></subparagraph></paragraph><paragraph id="H6185547630C64C10A4E3D9F585374594"><enum>(2)</enum><header>Submission</header><text>Not later than 2 years after the date of enactment of this section, the Administrator shall submit to Congress the report prepared under paragraph (1).</text></paragraph></subsection><subsection id="HA1BAD9012057404DB56EDAB2ACBBE4E0"><enum>(c)</enum><header>Inventory of materials recovery facilities</header><text>Not later than 3 years after the date of enactment of this section, and every 4 years thereafter, the Administrator, in consultation with relevant Federal agencies and States, units of local government, and Indian Tribes, shall—</text><paragraph id="H2E82A3B39D25461A8E5694172C162501"><enum>(1)</enum><text>prepare an inventory or estimate of materials recovery facilities in the United States, including—</text><subparagraph id="HEC43CF2C582B46B59D7D7ACE464A61F5"><enum>(A)</enum><text>the number of materials recovery facilities in each State; and</text></subparagraph><subparagraph id="H8B94D9C736444D96B17BF5C1CB3817D3"><enum>(B)</enum><text>a general description of the materials that each of those materials recovery facilities can process, including—</text><clause id="H10CF6A8FABD94BDCB6CF50D88CDC3699"><enum>(i)</enum><text>in the case of plastic, a description of—</text><subclause id="HF120E3096DD944D5B76D5DD3817AEC8A"><enum>(I)</enum><text>the types of accepted resin, if applicable; and</text></subclause><subclause id="H1EC0DFA1DD2B4B30A93759CD4E026196"><enum>(II)</enum><text>the packaging or product format, such as a jug, a carton, or film;</text></subclause></clause><clause id="HF1E72870D6F14843BD1D2E24F388A3EB"><enum>(ii)</enum><text>food packaging and service ware, such as a bottle, cutlery, or a cup;</text></clause><clause id="H4EDD9364EBF649AEA2F0F716D90D592C"><enum>(iii)</enum><text>paper;</text></clause><clause id="H3028A047EF9A40E28C50D364FC3F8D43"><enum>(iv)</enum><text>aluminum, such as an aluminum beverage can, food can, aerosol can, or foil;</text></clause><clause id="HD53665328D40438CA2EECDE6F6318329"><enum>(v)</enum><text>steel, such as a steel food or aerosol can;</text></clause><clause id="HA47AAD19E2444BB7AC68DB8BCB60DDFD"><enum>(vi)</enum><text>other scrap metal;</text></clause><clause id="H512010E0D3BE401FA3511C0474E2152D"><enum>(vii)</enum><text>glass; or</text></clause><clause id="HAA0F9C43C9184C3C83171661843EF2B4"><enum>(viii)</enum><text>any other material not described in any of clauses (i) through (vii) that a materials recovery facility processes; and</text></clause></subparagraph></paragraph><paragraph id="H6522FDE71A9049A3BC1939F870DAF2E0"><enum>(2)</enum><text>submit to Congress the inventory or estimate prepared under paragraph (1).</text></paragraph></subsection><subsection id="H0B9EDBF1C2F04FFE9F8E84E20F17F6AD"><enum>(d)</enum><header>Information on recycling and composting systems</header><text>The Administrator shall, as necessary and appropriate, collaborate or contract with States, units of local government, and Indian Tribes to estimate, with respect to the United States—</text><paragraph id="H5463FBB2AF8A451A958E9AADB8F1F9DA"><enum>(1)</enum><text>the number and types of recycling and composting programs;</text></paragraph><paragraph id="H949D711D6B004924A116A0A93FC43A58"><enum>(2)</enum><text>the types and forms of materials accepted by recycling or composting programs;</text></paragraph><paragraph id="H67D6B389B0BD4E489BA54DD8E04C9892"><enum>(3)</enum><text>the number of individuals—</text><subparagraph id="H527089BE9CC742F6B61F445698F81AA8"><enum>(A)</enum><text>with access to recycling and composting services to at least the extent of access to disposal services; and</text></subparagraph><subparagraph id="H3DB4D65126114557A34AE61C5EDF4029"><enum>(B)</enum><text>who use, on a percentage basis, the recycling and composting services described in subparagraph (A);</text></subparagraph></paragraph><paragraph id="HB9D1F08D4FCF4252A2A315D67A3CFECE"><enum>(4)</enum><text>the number of individuals with barriers to accessing recycling and composting services similar to their access to disposal services and the types of those barriers experienced;</text></paragraph><paragraph id="H8E8849A3BB5243BAA1D41D2AA068F6F1"><enum>(5)</enum><text>the inbound contamination and capture rates of recycling and composting programs; </text></paragraph><paragraph id="H86E466E7D75045BB8A5239E83E3BCD38"><enum>(6)</enum><text>if applicable, other available recycling or composting programs; and</text></paragraph><paragraph id="H1D1A221E78E247509EA1D51302AE0919"><enum>(7)</enum><text>the average costs and benefits to States, units of local government, and Indian Tribes of recycling and composting programs.</text></paragraph></subsection><subsection id="H1644C31C03AE42078AD2215740FA5066"><enum>(e)</enum><header>Recycling reporting rates</header><paragraph id="H27CEE4847FD0435DAD5241EC80CE8DA8"><enum>(1)</enum><header>Collection of data; development of rates</header><text>The Administrator may use amounts made available under subsection (f) of the <short-title>Recycling and Composting Accountability Act</short-title>—</text><subparagraph commented="no" display-inline="no-display-inline" id="HE1E6E9797ED34ED3BF5F2DE9FC416B67"><enum>(A)</enum><text display-inline="yes-display-inline">to biannually collect, in collaboration with States, to the extent practicable, information supplied on a voluntary basis to develop the estimated rates described in subparagraphs (B) and (C);</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8534A26EF31B48E5BF6D32E70DDC867F"><enum>(B)</enum><text display-inline="yes-display-inline">to develop a standardized estimated rate of recyclable materials in States that provide information under subparagraph (A) that have been successfully diverted from the waste stream and brought to a materials recovery facility or composting facility; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2D2EC33BCCDD4613A5C8129F8D276294"><enum>(C)</enum><text display-inline="yes-display-inline">to develop an estimated national recycling rate based on the information described in subparagraphs (A) and (B).</text></subparagraph></paragraph><paragraph id="H7C3252A39F3B4A87AA770B582990F0A3"><enum>(2)</enum><header>Use</header><text>Using amounts made available under subsection (f) of the <short-title>Recycling and Composting Accountability Act</short-title>, the Administrator may use the information collected and rates developed under paragraph (1) to provide requesting States, units of local government, and Indian Tribes data and technical assistance—</text><subparagraph commented="no" display-inline="no-display-inline" id="HD2E0B39C6169431E837F86114DEA8860"><enum>(A)</enum><text display-inline="yes-display-inline">to reduce the overall waste produced by the States, units of local government, and Indian Tribes;</text></subparagraph><subparagraph id="HD30B2D76292E439490FFC2220F38E38B"><enum>(B)</enum><text>to assist the States, units of local government, and Indian Tribes in understanding the nuances of the information collected relating to diversion activities; and </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB573112C0D1747A19345D4FE2903420B"><enum>(C)</enum><text display-inline="yes-display-inline">to increase recycling and composting rates of the States, units of local government, and Indian Tribes.</text></subparagraph></paragraph></subsection><subsection id="H28EDC6E92F4D480B9462A60A5E1ED68C"><enum>(f)</enum><header>Report on end markets</header><text>The Administrator, in collaboration or contract with, as necessary and appropriate, relevant Federal agencies, States, units of local government, or Indian Tribes, shall—</text><paragraph id="HCE89FEBE64044C84949A767299EA6D11"><enum>(1)</enum><text>provide an update to the report submitted under section 306 of the Save Our Seas 2.0 Act (<external-xref legal-doc="public-law" parsable-cite="pl/116/224">Public Law 116–224</external-xref>; 134 Stat. 1096) to include an addendum on the end-market sale of all recyclable materials from materials recovery facilities that process recyclable materials, including, to the extent practicable—</text><subparagraph id="HF77A263E989F48448167AF0426B47C60"><enum>(A)</enum><text>the total, in dollars per ton, domestic sales of bales of recyclable materials; and</text></subparagraph><subparagraph id="HCCDDE4CB30984E74B939ADE0C71CE16E"><enum>(B)</enum><text>the total, in dollars per ton, international sales of bales of recyclable materials;</text></subparagraph></paragraph><paragraph id="H735C7FCAA7004A9192FC70113AA38B84"><enum>(2)</enum><text>prepare a report on the end-market sale of compost from, to the extent practicable, compostable materials, including the total, in dollars per ton, of domestic sales of compostable materials; and</text></paragraph><paragraph id="H0670B61E39CA40C0935864776DB82430"><enum>(3)</enum><text>not later than 3 years after the date of enactment of this section, submit to Congress the update to the report prepared under paragraph (1) and the report prepared under paragraph (2).</text></paragraph></subsection><subsection id="H550F5267D1664DBDB13D718E67645ABB"><enum>(g)</enum><header>Privileged or confidential information</header><paragraph commented="no" display-inline="no-display-inline" id="HDA0FEDBCEDF04BDAA8C058BB158625E6"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Information collected under subsection (e)(1) or paragraph (1) or (2) of subsection (f) shall not include any privileged or confidential information described in section 552(b)(4) of title 5, United States Code.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H8B7D2DA105B346B7AE7508868BC77B90"><enum>(2)</enum><header>Nondisclosure</header><text display-inline="yes-display-inline">Information collected to carry out this section shall not be made public if the information meets the requirements of section 552(b) of title 5, United States Code.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6764CB30161249739D2EBD95898EC1A1"><enum>(2)</enum><header>Clerical amendment</header><text>The table of contents in section 1001 of the Solid Waste Disposal Act (<external-xref legal-doc="public-law" parsable-cite="pl/89/272">Public Law 89–272</external-xref>; 90 Stat. 2795; 98 Stat. 3268) is amended by inserting after the item relating to section 4010 the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H52C25AA2AED141DCBF710FACBAC7105E"><toc><toc-entry level="section" bold="off">Sec. 4011. Report on composting and recycling infrastructure capabilities.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HA12B0769D1174C2F87791B87E04AC7C4"><enum>(d)</enum><header>Federal agency activities related to recycling</header><text display-inline="yes-display-inline">Not later than 2 years after the date of enactment of this Act, and every 2 years thereafter until 2033, the Comptroller General of the United States shall make publicly available a report—</text><paragraph commented="no" display-inline="no-display-inline" id="HF1AD4DD1877D4642ADB2290C1E76702D"><enum>(1)</enum><text display-inline="yes-display-inline">detailing or, to the extent practicable, providing an estimate of—</text><subparagraph id="H922F5A54D38E4B45AD38D16532D0CF69"><enum>(A)</enum><text>the total annual recycling and composting rates reported by all Federal agencies; and</text></subparagraph><subparagraph id="H771A8413FCF34982BC4162924B1E33E2"><enum>(B)</enum><text>the total annual percentage of products containing recyclable material, compostable material, or recovered materials purchased by all Federal agencies, including—</text><clause id="H04FBF96B48874C77ACD0B2CB1B1F40C8"><enum>(i)</enum><text>the total quantity of procured products containing recyclable material or recovered materials listed in the comprehensive procurement guidelines published under section 6002(e) of the Solid Waste Disposal Act (<external-xref legal-doc="usc" parsable-cite="usc/42/6962">42 U.S.C. 6962(e)</external-xref>); and</text></clause><clause id="HFE65003E56984F7B92B57939DD012762"><enum>(ii)</enum><text>the total quantity of compostable material purchased by all Federal agencies;</text></clause></subparagraph></paragraph><paragraph id="HA71B0F4FA3064BD2BE4BBDDC807185C7"><enum>(2)</enum><text>identifying the activities of each Federal agency that promote recycling or composting; and</text></paragraph><paragraph id="H15C9E76A96CB4719B8FFCF0994D3C915"><enum>(3)</enum><text>identifying activities that Federal agencies could carry out to further promote recycling or composting.</text></paragraph></subsection><subsection id="H5F7A62794CC242A2AE4F301B98D44585"><enum>(e)</enum><header>Study on the diversion of recyclable materials from a circular market</header><paragraph id="H08C1E935CA9043EDAB955DC63DAFB116"><enum>(1)</enum><header>In general</header><text>Not later than 1 year after the date of enactment of this Act, the Administrator shall develop a metric for determining the proportion of recyclable materials in commercial and municipal waste streams that are being diverted from a circular market.</text></paragraph><paragraph id="HBF0B49279858459E80159FF816145531"><enum>(2)</enum><header>Study; report</header><text>Not later than 1 year after the development of a metric under paragraph (1), the Administrator shall conduct a study of, and submit to Congress a report on, the proportion of recyclable materials in commercial and municipal waste streams that, during each of the 10 calendar years preceding the year of submission of the report, were diverted from a circular market.</text></paragraph><paragraph id="HA3371C8DBA51487E847B1EF874F2EAD4"><enum>(3)</enum><header>Data</header><text>The report under paragraph (2) shall provide data on specific recyclable materials, including aluminum, plastics, paper and paperboard, textiles, and glass, that were prevented from remaining in a circular market through disposal or elimination, and to what use those specific recyclable materials were lost.</text></paragraph><paragraph id="H276FDDEF83BE4DB088C7BA1C12329F85"><enum>(4)</enum><header>Evaluation</header><text>The report under paragraph (2) shall include an evaluation of whether the establishment or improvement of recycling programs would—</text><subparagraph id="HE195DB6BFFC242FBBD66CFA66B1E4021"><enum>(A)</enum><text>improve recycling rates;</text></subparagraph><subparagraph id="H2B46AC8CA7924C05B90EDE1064BDA9BB"><enum>(B)</enum><text>reduce the quantity of recyclable materials being unutilized in a circular market; and</text></subparagraph><subparagraph id="HE6322AF42F074C168B2A38D93616135E"><enum>(C)</enum><text>affect prices paid by consumers for products using materials recycled in the circular market.</text></subparagraph></paragraph></subsection><subsection id="H2145E3C494B444DCB73E6DF05DB35C97"><enum>(f)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">There is authorized to be appropriated to the Administrator to carry out this section and the amendments made by this section $4,000,000 for each of fiscal years 2025 through 2029.</text></subsection><subsection commented="no" id="H2C700F0F76FE48329323EFFFCEAF0B86"><enum>(g)</enum><header>Administration</header><paragraph id="HBB558B27BCDC4F509C9B918261448D48"><enum>(1)</enum><header>Unfunded mandates</header><text display-inline="yes-display-inline">The Administrator or the Secretary of Commerce may not exercise any authority under this section or any amendment made by this section if exercising that authority would require a State, a unit of local government, or an Indian Tribe to carry out a mandate for which funding is not available.</text></paragraph><paragraph id="HDD96239AE7CB47B6922D8633684DC8A6" commented="no" display-inline="no-display-inline"><enum>(2)</enum><header display-inline="yes-display-inline">Nondisclosure</header><text display-inline="yes-display-inline">Any information collected to carry out this section shall not be made public if the information meets the requirements of section 552(b) of title 5, United States Code.</text></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="H48F7D355ECB14C588F5A17403465414F"><enum>102.</enum><header display-inline="yes-display-inline">Recycling Infrastructure and Accessibility Program</header><subsection commented="no" display-inline="no-display-inline" id="H20D3804C434840D0A123BAD9E5FEEF2A"><enum>(a)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this section:</text><paragraph commented="no" display-inline="no-display-inline" id="H2B9E11CB563842F6B5F8DA03D36B58B4"><enum>(1)</enum><header display-inline="yes-display-inline">Administrator</header><text display-inline="yes-display-inline">The term <term>Administrator</term> means the Administrator of the Environmental Protection Agency.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4C5CF884AD294D048F0F32A81D146D1D"><enum>(2)</enum><header display-inline="yes-display-inline">Curbside recycling</header><text display-inline="yes-display-inline">The term <term>curbside recycling</term> means the process by which residential recyclable materials are picked up curbside.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE50CBD3CA2C743AEA1698314B1285C64"><enum>(3)</enum><header display-inline="yes-display-inline">Eligible entity</header><text display-inline="yes-display-inline">The term <term>eligible entity</term> means—</text><subparagraph commented="no" display-inline="no-display-inline" id="H3EB55E0693C84B6A9DB2E3A643FF7685"><enum>(A)</enum><text display-inline="yes-display-inline">a State (as defined in section 1004 of the Solid Waste Disposal Act (<external-xref legal-doc="usc" parsable-cite="usc/42/6903">42 U.S.C. 6903</external-xref>));</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H864F45CFFD5E4A1589CE75932074D88C"><enum>(B)</enum><text display-inline="yes-display-inline">a unit of local government;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB9E404324AF641F89FD30B7AA48C37AC"><enum>(C)</enum><text display-inline="yes-display-inline">an Indian Tribe; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H53DBF560A3FE4D3C8E31C1F37E82CC7F"><enum>(D)</enum><text display-inline="yes-display-inline">a public-private partnership.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H498323A4F59549D395051F8F2FAB9058"><enum>(4)</enum><header display-inline="yes-display-inline">Indian Tribe</header><text display-inline="yes-display-inline">The term <term>Indian Tribe</term> has the meaning given the term in section 4 of the Indian Self-Determination and Education Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/25/5304">25 U.S.C. 5304</external-xref>).</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H845F0EB65ADF49EDB8733DBD8AF0A7FC"><enum>(5)</enum><header display-inline="yes-display-inline">Materials recovery facility</header><subparagraph commented="no" display-inline="no-display-inline" id="HF8D071AD6FE74DE88D5DD80172C9FC1D"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The term <term>materials recovery facility</term> means a recycling facility where primarily residential recyclables, which are diverted from disposal by a generator and collected separately from municipal solid waste, are mechanically or manually sorted into commodities for further processing into specification-grade commodities for sale to end users.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H815C280DC1D5406E9FC58B8D561E0A3B"><enum>(B)</enum><header display-inline="yes-display-inline">Exclusion</header><text display-inline="yes-display-inline">The term <term>materials recovery facility</term> does not include a solid waste management facility that may process municipal solid waste to remove recyclable materials. </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H40344AFE8EE044258B4D953E99F853D0"><enum>(6)</enum><header display-inline="yes-display-inline">Pilot grant program</header><text display-inline="yes-display-inline">The term <term>pilot grant program</term> means the Recycling Infrastructure and Accessibility Program established under subsection (b).</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H20488C096E6A4D2B8135FC79335836E4"><enum>(7)</enum><header display-inline="yes-display-inline">Recyclable material</header><text display-inline="yes-display-inline">The term <term>recyclable material</term> means obsolete, previously used, off-specification, surplus, or incidentally produced material for processing into a specification-grade commodity for which a market exists.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDFEF8A2B274646C19901C1ED441AD4E5"><enum>(8)</enum><header display-inline="yes-display-inline">Transfer station</header><text display-inline="yes-display-inline">The term <term>transfer station</term> means a facility that—</text><subparagraph commented="no" display-inline="no-display-inline" id="HF05B232220B14E5893058D78380ED397"><enum>(A)</enum><text display-inline="yes-display-inline">receives and consolidates recyclable material from curbside recycling or drop-off facilities; and </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB5A6A1ECE1284FA188925859C166E97E"><enum>(B)</enum><text display-inline="yes-display-inline">loads the recyclable material onto tractor trailers, railcars, or barges for transport to a distant materials recovery facility or another recycling-related facility. </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H952F4BA0235B45D0A7099E36E10FDFA6"><enum>(9)</enum><header display-inline="yes-display-inline">Underserved community</header><text display-inline="yes-display-inline">The term <term>underserved community</term> means a community, including an unincorporated area, without access to full recycling services because—</text><subparagraph commented="no" display-inline="no-display-inline" id="H6C82C5946FDF4CB896752B139DF1FE55"><enum>(A)</enum><text display-inline="yes-display-inline">transportation, distance, or other reasons render utilization of available processing capacity at an existing materials recovery facility cost prohibitive; or</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF7BF3A4421A64032A9F931CEE876FD1B"><enum>(B)</enum><text display-inline="yes-display-inline">the processing capacity of an existing materials recovery facility is insufficient to manage the volume of recyclable materials produced by that community. </text></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HA308C901CF2940EBBB099EC4DCD2721D"><enum>(b)</enum><header display-inline="yes-display-inline">Establishment</header><text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of this Act, the Administrator shall establish a pilot grant program, to be known as the <quote>Recycling Infrastructure and Accessibility Program</quote>, to award grants, on a competitive basis, to eligible entities to improve recycling accessibility in a community or communities within the same geographic area.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H266F6CE2F3F94B4FB8B9EAAF936DA277"><enum>(c)</enum><header display-inline="yes-display-inline">Goal</header><text display-inline="yes-display-inline">The goal of the pilot grant program is to fund eligible projects that will significantly improve accessibility to recycling systems through investments in infrastructure in underserved communities through the use of a hub-and-spoke model for recycling infrastructure development.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H80A182CC84534076A9DDC7521D1D0E29"><enum>(d)</enum><header display-inline="yes-display-inline">Applications</header><text display-inline="yes-display-inline">To be eligible to receive a grant under the pilot grant program, an eligible entity shall submit to the Administrator an application at such time, in such manner, and containing such information as the Administrator may require.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="HBB2E5DD61A554A3B9C85A7B184285954"><enum>(e)</enum><header display-inline="yes-display-inline">Considerations</header><text display-inline="yes-display-inline">In selecting eligible entities to receive a grant under the pilot grant program, the Administrator shall consider—</text><paragraph commented="no" display-inline="no-display-inline" id="H825BADAFC6BD44CAACAD0FB83CBADA7E"><enum>(1)</enum><text display-inline="yes-display-inline">whether the community or communities in which the eligible entity is seeking to carry out a proposed project has curbside recycling;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDD27AB391E0A4CFBB836EE644013A651"><enum>(2)</enum><text display-inline="yes-display-inline">whether the proposed project of the eligible entity will improve accessibility to recycling services in a single underserved community or multiple underserved communities; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF7FEF884A53F454FB825B47756337355"><enum>(3)</enum><text display-inline="yes-display-inline">if the eligible entity is a public-private partnership, the financial health of the private entity seeking to enter into that public-private partnership.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H7D2A24E07AA54DAC857136E6C3C6DD2E"><enum>(f)</enum><header display-inline="yes-display-inline">Priority</header><text display-inline="yes-display-inline">In selecting eligible entities to receive a grant under the pilot grant program, the Administrator shall give priority to eligible entities seeking to carry out a proposed project in a community in which there is not more than 1 materials recovery facility within a 75-mile radius of that community.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H998302B74FAF41CCB20A34280476B8F4"><enum>(g)</enum><header display-inline="yes-display-inline">Use of funds</header><text display-inline="yes-display-inline">An eligible entity awarded a grant under the pilot grant program may use the grant funds for projects to improve recycling accessibility in communities, including in underserved communities, by—</text><paragraph commented="no" display-inline="no-display-inline" id="HD135D3173E8844AF88AC9F274740B953"><enum>(1)</enum><text display-inline="yes-display-inline">increasing the number of transfer stations;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H40D7BA91FEDC4BD8843BA88A9CA081EC"><enum>(2)</enum><text display-inline="yes-display-inline">expanding curbside recycling collection programs where appropriate; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF464732DA989413189FCB65ABE8D4860"><enum>(3)</enum><text display-inline="yes-display-inline">leveraging public-private partnerships to reduce the costs associated with collecting and transporting recyclable materials in underserved communities.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HE2537691444F46B980F0B562BB522437"><enum>(h)</enum><header display-inline="yes-display-inline">Prohibition on use of funds</header><text display-inline="yes-display-inline">An eligible entity awarded a grant under the pilot grant program may not use the grant funds for projects relating to recycling education programs.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H52F77E1E3F414CB1ABE51A84ABFE65D9"><enum>(i)</enum><header display-inline="yes-display-inline">Minimum and maximum grant amount</header><text display-inline="yes-display-inline">A grant awarded to an eligible entity under the pilot grant program shall be in an amount—</text><paragraph commented="no" display-inline="no-display-inline" id="HDEA99347A5184FC0BEDD6260975E9119"><enum>(1)</enum><text display-inline="yes-display-inline">not less than $500,000; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HE1003E65778548B194436EA41E7BC89C"><enum>(2)</enum><text display-inline="yes-display-inline">not more than $15,000,000.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H3DB0DFD14B1A4797A3BA1CBB1A0F3623"><enum>(j)</enum><header display-inline="yes-display-inline">Set-Aside</header><text display-inline="yes-display-inline">The Administrator shall set aside not less than 70 percent of the amounts made available to carry out the pilot grant program for each fiscal year to award grants to eligible entities to carry out a proposed project or program in a single underserved community or multiple underserved communities. </text></subsection><subsection commented="no" display-inline="no-display-inline" id="HF7DC6052E26A4886B74CC1A82B45C4CF"><enum>(k)</enum><header display-inline="yes-display-inline">Federal share</header><text display-inline="yes-display-inline">The Federal share of the cost of a project or program carried out by an eligible entity using grant funds shall be not more than 95 percent.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="HC0737887BC32453EB226FFE79AFB5737"><enum>(l)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">Not later than 2 years after the date on which the first grant is awarded under the pilot grant program, the Administrator shall submit to Congress a report describing the implementation of the pilot grant program, which shall include—</text><paragraph commented="no" display-inline="no-display-inline" id="H0B1E4046103E4126A1DB25374D570E4F"><enum>(1)</enum><text display-inline="yes-display-inline">a list of eligible entities that have received a grant under the pilot grant program; </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H867799B3903348959CC88CB7535F9541"><enum>(2)</enum><text display-inline="yes-display-inline">the actions taken by each eligible entity that received a grant under the pilot grant program to improve recycling accessibility with grant funds; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD4092485DCC243F39134AE532DE7A2F3"><enum>(3)</enum><text display-inline="yes-display-inline">to the extent information is available, a description of how grant funds received under the pilot grant program improved recycling rates in each community in which a project or program was carried out under the pilot grant program.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HA9E50414D984489885353147C0C851F2"><enum>(m)</enum><header display-inline="yes-display-inline">Authorization of appropriations</header><paragraph commented="no" display-inline="no-display-inline" id="H49556DBE08F24784A55C4DD3CDB844F3"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">There is authorized to be appropriated to the Administrator to carry out the pilot grant program $30,000,000 for each of fiscal years 2025 through 2029, to remain available until expended.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4DD64B89FD9240CBAB90A0F3B30478F0"><enum>(2)</enum><header display-inline="yes-display-inline">Administrative costs and technical assistance</header><text display-inline="yes-display-inline">Of the amounts made available under paragraph (1), the Administrator may use up to 5 percent—</text><subparagraph commented="no" display-inline="no-display-inline" id="H67AAEF4FF8C2485888B653A5B218DF09"><enum>(A)</enum><text display-inline="yes-display-inline">for administrative costs relating to carrying out the pilot grant program; and</text></subparagraph><subparagraph id="H4DDE33A7D994483CBB1750FB4B80F219" commented="no" display-inline="no-display-inline"><enum>(B)</enum><text display-inline="yes-display-inline">to provide technical assistance to eligible entities applying for a grant under the pilot grant program. </text></subparagraph></paragraph></subsection></section><section id="H93A2B3AEC0854194BD3D830D54A2C849"><enum>103.</enum><header>Drinking water infrastructure risk and resilience</header><text display-inline="no-display-inline">Section 1433(g) of the Safe Drinking Water Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300i-2">42 U.S.C. 300i–2(g)</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="HD987F9B9D0334A29A7069772AD5AB0EA"><enum>(1)</enum><text>in paragraph (1), by striking <quote>2020 and 2021</quote> and inserting <quote>2026 and 2027</quote>;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H72B4D92AF179478FAAA092C8CA1501CA"><enum>(2)</enum><text>in paragraph (4), by striking <quote>$5,000,000</quote> and inserting <quote>$10,000,000</quote>;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD9CA10DBAC204599828CF115B2E527EC"><enum>(3)</enum><text>in paragraph (5), by striking <quote>$10,000,000</quote> and inserting <quote>$20,000,000</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H07E6393EB1244B18AA77E28DA5F5E9F4"><enum>(4)</enum><text>in paragraph (6)—</text><subparagraph commented="no" display-inline="no-display-inline" id="H64BE194C714A4328B77B125037BA04F3"><enum>(A)</enum><text>by striking <quote>$25,000,000</quote> and inserting <quote>$50,000,000</quote>; and</text></subparagraph><subparagraph id="H524712B6BC4D44D18800241D00C362AE"><enum>(B)</enum><text>by striking <quote>2020 and 2021</quote> and inserting <quote>2026 and 2027</quote>. </text></subparagraph></paragraph></section><section id="H11C6606E414F43E28F6D270559BC90E2" commented="no" display-inline="no-display-inline" section-type="subsequent-section"><enum>104.</enum><header display-inline="yes-display-inline">Reauthorization of Diesel Emissions Reduction Act</header><text display-inline="no-display-inline">Section 797(a) of the Energy Policy Act of 2005 (<external-xref legal-doc="usc" parsable-cite="usc/42/16137">42 U.S.C. 16137(a)</external-xref>) is amended by striking <quote>2024</quote> and inserting <quote>2029</quote>. </text></section><section id="H685A2A43CDB64CB2AEA847973B303C27"><enum>105.</enum><header>Nationwide Consumer and Fuel Retailer Choice Act</header><subsection id="H5C4844B2E3A2483F9BC892B782504D0A"><enum>(a)</enum><header>Short title</header><text display-inline="yes-display-inline">This section may be cited as the <quote><short-title>Nationwide Consumer and Fuel Retailer Choice Act</short-title></quote>.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H40333743E88C437385E5186252138975"><enum>(b)</enum><header>Ethanol waiver</header><paragraph commented="no" display-inline="no-display-inline" id="HDBC7BBEE62C64403B9677A9145C60BCB"><enum>(1)</enum><header>Existing waivers</header><text>Section 211(f)(4) of the Clean Air Act (<external-xref legal-doc="usc" parsable-cite="usc/42/7545">42 U.S.C. 7545(f)(4)</external-xref>) is amended—</text><subparagraph commented="no" display-inline="no-display-inline" id="H3041735D78E94DDB8CFB7D5C8DF32107"><enum>(A)</enum><text>by striking <quote>(4) The Administrator, upon</quote> and inserting the following:</text><quoted-block style="OLC" id="H9CDE01B5A32C4CF7867E3D636FF64C67" act-name=""><paragraph id="H9335F51890EB48819222F121C5A3890B"><enum>(4)</enum><header>Waivers</header><subparagraph commented="no" display-inline="no-display-inline" id="HF663BC705FE4433DB08734966EF297C9"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text>The Administrator, on</text></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H954DF04EF85B49468D33554462482A14"><enum>(B)</enum><text>in subparagraph (A) (as so designated)—</text><clause commented="no" display-inline="no-display-inline" id="H09ED6E243BB142888711A32198C65A61"><enum>(i)</enum><text display-inline="yes-display-inline">in the first sentence—</text><subclause commented="no" display-inline="no-display-inline" id="H9C09EA42E2034F8D90D19F657F17884A"><enum>(I)</enum><text>by striking <quote>of this subsection</quote> each place it appears; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H2B91FC2AF0FE40A5A36965401D5821EA"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>if he determines</quote> and inserting <quote>if the Administrator determines</quote>; and</text></subclause></clause><clause commented="no" display-inline="no-display-inline" id="H92C55574AFA44D0189011616460E1ED4"><enum>(ii)</enum><text>in the second sentence, by striking <quote>The Administrator</quote> and inserting the following:</text><quoted-block style="OLC" id="H7D8CFCC2F3084CF694B95A710581FF1A" act-name=""><subparagraph id="HD5963946802B47679355B5D3657F7E26"><enum>(B)</enum><header>Final action</header><text>The Administrator</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4130A40E56CB49A7A7F4342EA90E0F55"><enum>(C)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" id="H529B91A27AE6432AB57F40981E2A8104" act-name=""><subparagraph id="H2C690749081E40459DD81E86E73F60A1"><enum>(C)</enum><header>Reid vapor pressure</header><text>A fuel or fuel additive may be introduced into commerce if—</text><clause commented="no" display-inline="no-display-inline" id="H420508C4EF3F46CC9F62F1A5088AB5F6"><enum>(i)</enum><subclause commented="no" display-inline="yes-display-inline" id="H89492437FBCA41828D5607F905967B54"><enum>(I)</enum><text>the Administrator determines that the fuel or fuel additive is substantially similar to a fuel or fuel additive utilized in the certification of any model year vehicle pursuant to paragraph (1)(A); or</text></subclause><subclause commented="no" display-inline="no-display-inline" indent="up1" id="HA9776C538CD548D4B472A12D8170A01F"><enum>(II)</enum><text>the fuel or fuel additive has been granted a waiver under subparagraph (A) and meets all of the conditions of that waiver other than any limitation of the waiver with respect to the Reid Vapor Pressure of the fuel or fuel additive; and</text></subclause></clause><clause id="HAC0EEAF87B824CB88FFF70C1FEE319FC"><enum>(ii)</enum><text>the fuel or fuel additive meets all other applicable Reid Vapor Pressure requirements under subsection (h).</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H90D3BDF7A251435BA09C6673CE7DA479"><enum>(2)</enum><header>Reid vapor pressure limitation</header><text>Section 211(h) of the Clean Air Act (<external-xref legal-doc="usc" parsable-cite="usc/42/7545">42 U.S.C. 7545(h)</external-xref>) is amended—</text><subparagraph commented="no" display-inline="no-display-inline" id="HB70E00AC79C446BDA2A034A7B8D341F4"><enum>(A)</enum><text>by striking <quote>vapor pressure</quote> each place it appears and inserting <quote>Vapor Pressure</quote>;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H489E0442856348FB880345D7CB4C7721"><enum>(B)</enum><text>in paragraph (4), in the matter preceding subparagraph (A), by striking <quote>10 percent</quote> and inserting <quote>10 to 15 percent</quote>; and</text></subparagraph><subparagraph id="HFAB773BBDA864AC8A9218A5F47380983"><enum>(C)</enum><text>in paragraph (5)(A)—</text><clause commented="no" display-inline="no-display-inline" id="H698FC6726840439BA5F637CE73FF4458"><enum>(i)</enum><text>by striking <quote>Upon notification, accompanied by</quote> and inserting <quote>On receipt of a notification that is submitted after the date of enactment of the <short-title>Nationwide Consumer and Fuel Retailer Choice Act</short-title>, and is accompanied by appropriate</quote>;</text></clause><clause commented="no" display-inline="no-display-inline" id="H0C67609179D84ABDB2C63788ED884F33"><enum>(ii)</enum><text>by striking <quote>10 percent</quote> and inserting <quote>10 to 15 percent</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H500B47413260452DA4447BDBAA47CF2C"><enum>(iii)</enum><text>by adding at the end the following: <quote>Upon the enactment of the <short-title>Nationwide Consumer and Fuel Retailer Choice Act</short-title>, any State for which the notification from the Governor of a State was submitted before the date of enactment of the <short-title>Nationwide Consumer and Fuel Retailer Choice Act</short-title> and to which the Administrator applied the Reid Vapor Pressure limitation established by paragraph (1) shall instead have the Reid Vapor Pressure limitation established by paragraph (4) apply to all fuel blends containing gasoline and 10 to 15 percent denatured anhydrous ethanol that are sold, offered for sale, dispensed, supplied, offered for supply, transported, or introduced into commerce in the area during the high ozone season.</quote>. </text></clause></subparagraph></paragraph></subsection><subsection id="H088FD0C8D7BA45E682F241D61B17FE81"><enum>(c)</enum><header>Generation of credits by small refineries under the renewable fuel program</header><text display-inline="yes-display-inline">Section 211(o)(9) of the Clean Air Act (<external-xref legal-doc="usc" parsable-cite="usc/42/7545">42 U.S.C. 7545(o)(9)</external-xref>) is amended by adding at the end the following:</text><quoted-block id="H04003CECAC34413888C8332A88755059" display-inline="no-display-inline" style="OLC"><subparagraph id="HA771D3B3C20E4208BDAFEFBE0CE4EB2E"><enum>(E)</enum><header>Credits generated for 2016–2018 compliance years</header><clause id="H93BF7553FBD241C09957C6C7E2492A31"><enum>(i)</enum><header>Rule</header><text display-inline="yes-display-inline">For any small refinery described in clause (ii) or (iii), the credits described in the respective clause shall be—</text><subclause id="HF4978BB0A9B441AFB1F8B28D091F1B9B"><enum>(I)</enum><text>returned to the small refinery and, notwithstanding paragraph (5)(C), deemed eligible for future compliance years; or</text></subclause><subclause id="H9F0ECA6CB641411394E93206E3C0C09D"><enum>(II)</enum><text>applied as a credit in the EPA Moderated Transaction System (EMTS) account of the small refinery.</text></subclause></clause><clause id="HCB7692CBC9094AC7AE3607887C2CA1D0"><enum>(ii)</enum><header>Compliance years 2016 and 2017</header><text display-inline="yes-display-inline">Clause (i) applies with respect to any small refinery that—</text><subclause id="H475FD7CEECE2475E910141001CAF4F07"><enum>(I)</enum><text>retired credits generated for compliance years 2016 or 2017; and</text></subclause><subclause id="HB543A6E3E1484BD4B3F4B41BDDBD1D1D"><enum>(II)</enum><text>submitted a petition under subparagraph (B)(i) for that compliance year that remained outstanding as of December 1, 2022.</text></subclause></clause><clause id="H8EC00B2FCAD04DD5AC6C61DBE2D9F112"><enum>(iii)</enum><header>Compliance year 2018</header><text>In addition to small refineries described in clause (ii), clause (i) applies with respect to any small refinery—</text><subclause commented="no" display-inline="no-display-inline" id="HF9D349A5DD72480CB472133653BC2A24"><enum>(I)</enum><text display-inline="yes-display-inline">that submitted a petition under subparagraph (B)(i) for compliance year 2018 by September 1, 2019;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H2186A17658E1435C97A72D7A17C2AC9D"><enum>(II)</enum><text>that retired credits generated for compliance year 2018 as part of the compliance demonstration of the small refinery for compliance year 2018 by March 31, 2019; and</text></subclause><subclause id="H0B9D7D9BB0B24D6BBC3CA440B705E5AA"><enum>(III)</enum><text>for which—</text><item commented="no" display-inline="no-display-inline" id="H32FDA268554E4C6C924255D41BB5F5EE"><enum>(aa)</enum><text display-inline="yes-display-inline">the petition remained outstanding as of December 1, 2022; or</text></item><item id="H4324DC36F5404BC990C98228471900A3" commented="no" display-inline="no-display-inline"><enum>(bb)</enum><text>the Administrator denied the petition as of July 1, 2022, and has not returned the retired credits as of December 1, 2022.</text></item></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection commented="no" display-inline="no-display-inline" id="HBA8A357FC9D142D4B2406457426B96F0"><enum>(d)</enum><header>Addressing renewable fuel market manipulation and transparency</header><text>Not later than 90 days after the date of enactment of this Act, the Administrator of the Environmental Protection Agency, in collaboration with the Commodity Futures Trading Commission, shall—</text><paragraph id="HF8B8E74BAEF641C7A8DC29F235AFD337"><enum>(1)</enum><text>review all applicable Renewable Identification Number (as described in section 80.1425 of title 40, Code of Federal Regulations (or successor regulations)) data collected for the EPA Moderated Transaction System (as defined in section 80.2 of title 40, Code of Federal Regulations (or successor regulations)); and</text></paragraph><paragraph id="H85E1D87C59724CD2A71072B86E248325"><enum>(2)</enum><text>submit to Congress a report that identifies any additional data that should be collected to reduce renewable fuel market manipulation. </text></paragraph></subsection></section></division><division id="H1774B123FEFA4A109F778F041A70C63E"><enum>B</enum><header>Commerce</header><title id="HD25527F16C9A40CEBC5A56DDA9ED2DC0"><enum>I</enum><header>Youth Poisoning Prevention</header><section id="HAB803D8D5A5F4855AD55DDE195AF065A"><enum>101.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Youth Poisoning Protection Act</quote>.</text></section><section id="H73C22C21E4D74B778576939DE3594198" changed="not-changed"><enum>102.</enum><header>Banning of products containing a high concentration of sodium nitrite</header><subsection id="HECA7F8C0FD6042118B7BEA0E00FE13F9" changed="not-changed"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Any consumer product containing a high concentration of sodium nitrite shall be considered to be a banned hazardous product under section 8 of the Consumer Product Safety Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2057">15 U.S.C. 2057</external-xref>).</text></subsection><subsection id="HC21F74D37F0E44E18F9458646FE3E7B3" changed="not-changed"><enum>(b)</enum><header>Rule of construction</header><text>Nothing in this section shall be construed to—</text><paragraph commented="no" display-inline="no-display-inline" id="H010B0F517125468B927D912ABB88684A" changed="not-changed"><enum>(1)</enum><text display-inline="yes-display-inline">prohibit any commercial or industrial purpose in which high concentration sodium nitrite is not customarily produced or distributed for sale to, or use or consumption by, or enjoyment of, a consumer; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H092B5FD5EE8341ACBAA1F329CDCADE36" changed="not-changed"><enum>(2)</enum><text display-inline="yes-display-inline">apply to high concentration sodium nitrite that meets the definition of a drug, device, or cosmetic (as such terms are defined in sections 201(g), (h), and (i) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321(g)</external-xref>, (h), and (i))), or food (as defined in section 201(f) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321(f)</external-xref>)), including poultry and poultry products (as such terms are defined in sections 4(e) and (f) of the Poultry Products Inspection Act (<external-xref legal-doc="usc" parsable-cite="usc/21/453">21 U.S.C. 453(e)</external-xref> and (f))), meat and meat food products (as such terms are defined in section 1(j) of the Federal Meat Inspection Act (<external-xref legal-doc="usc" parsable-cite="usc/21/601">21 U.S.C. 601(j)</external-xref>)), and eggs and egg products (as such terms are defined in section 4 of the Egg Products Inspection Act (<external-xref legal-doc="usc" parsable-cite="usc/21/1033">21 U.S.C. 1033</external-xref>)). </text></paragraph></subsection><subsection id="H126A498FC7894B558780101F85C36D13" changed="not-changed"><enum>(c)</enum><header>Definitions</header><text>For purposes of this section:</text><paragraph id="H8538E6904BE14948B4BB6CD012565E66" changed="not-changed"><enum>(1)</enum><header>Consumer product</header><text display-inline="yes-display-inline">The term consumer product has the meaning given that term under section 3(a)(5) of the Consumer Product Safety Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2052">15 U.S.C. 2052(a)(5)</external-xref>).</text></paragraph><paragraph id="HC72F744F011B406E9CCFCCD78F40C240" changed="not-changed"><enum>(2)</enum><header>High concentration of sodium nitrite</header><text>The term high concentration of sodium nitrite means a concentration of 10 or more percent by weight of sodium nitrite.</text></paragraph></subsection><subsection id="H6C6D3329F8674901A151E6ECAF72CBF6" changed="not-changed"><enum>(d)</enum><header>Effective date</header><text>This section shall take effect 90 days after the date of enactment of this Act.</text></subsection></section></title><title id="H001223A32A70472B84C6DD053667F6C0" style="OLC"><enum>II</enum><header>Consumer Product Safety Standard for Certain Batteries</header><section id="H45F14149A7164181B637D0FCFD866937"><enum>201.</enum><header>Consumer product safety standard for certain batteries</header><subsection id="H6C48A16A034E48179B71F27455DFD7C7" commented="no"><enum>(a)</enum><header>Consumer product safety standard required</header><text>Not later than 180 days after the date of the enactment of this Act, the Consumer Product Safety Commission (referred to in this section as the <quote>Commission</quote>) shall promulgate, under section 553 of title 5, United States Code, the provisions of ANSI/CAN/UL 2271–Standard for Batteries for Use in Light Electric Vehicle Applications, ANSI/CAN/UL 2849–Standard for Safety for Electrical Systems for eBikes, and ANSI/CAN/UL 2272–Standard for Electrical Systems for Personal E–Mobility Devices, as in effect on the date of enactment of this Act, as final consumer product safety standards.</text></subsection><subsection id="HD4B96CF666F048678B7997195AC75733"><enum>(b)</enum><header>Consumer Product Safety Commission determination of scope</header><text>In adopting the standards under subsection (a), the Commission shall limit the application of such standards to consumer products as defined in section 3(a)(5) of the Consumer Product Safety Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2052">15 U.S.C. 2052(a)(5)</external-xref>).</text></subsection><subsection id="H8AC606A2517D4A168B5959D8AB12E5A7"><enum>(c)</enum><header>Revision of voluntary standards</header><paragraph id="H81571E0C301B4E85B028B8471B32AF0A"><enum>(1)</enum><header>Notice to Commission</header><text>If the provisions of ANSI/CAN/UL 2271–Standard for Batteries for Use in Light Electric Vehicle Applications, ANSI/CAN/UL 2849–Standard for Safety for Electrical Systems for eBikes, or ANSI/CAN/UL 2272–Standard for Electrical Systems for Personal E–Mobility Devices, are revised following the enactment of this Act, the organization that revised the requirements of such standard shall notify the Commission after the final approval of the revision.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBBA9F4C369A541B2831E950B642DE3AF"><enum>(2)</enum><header>Treatment of revision</header><text display-inline="yes-display-inline">The revised voluntary standard shall be considered to be a consumer product safety standard issued by the Commission under section 9 of the Consumer Product Safety Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2058">15 U.S.C. 2058</external-xref>), effective 180 days after the date on which the organization notifies the Commission (or such later date specified by the Commission in the Federal Register) unless, within 90 days after receiving that notice, the Commission notifies the organization that it has determined that the proposed revision, in whole or in part, does not improve the safety of the consumer product covered by the standard and that the Commission is retaining the existing consumer product safety standard. </text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HDEB093A8B180475E911DCF56A1B81BA2"><enum>(d)</enum><header>Treatment of standard</header><text display-inline="yes-display-inline">A standard promulgated under this section, including a revision of such standard adopted by the Commission, shall be treated as a consumer product safety rule promulgated under section 9 of the Consumer Product Safety Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2058">15 U.S.C. 2058</external-xref>).</text></subsection><subsection id="HF2FAC28D41D446128C4276AE78273F44"><enum>(e)</enum><header>Report to Congress</header><paragraph id="HE684806E3B5340F7ABB02068D91D29A8"><enum>(1)</enum><header>In general</header><text>Not later than 5 years after the date of enactment of this Act, the Commission shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report regarding fires, explosions, and other hazards relating to lithium-ion batteries used in micromobility products during the period beginning on the date of enactment of this Act and ending on the report date.</text></paragraph><paragraph id="H6898ADA49B7841E3825EF61B71D6DA27"><enum>(2)</enum><header>Content</header><text>The report required by paragraph (1) shall describe, at a minimum—</text><subparagraph id="H005099342EB0469E8A8E04BD1039E941"><enum>(A)</enum><text>the source of the information that was provided to the Commission regarding the fire, explosion, or other hazard;</text></subparagraph><subparagraph id="H4598A4B8ABB74F0AA94B61BAAEF895E5"><enum>(B)</enum><text>the make and model of the lithium-ion battery and micromobility product that resulted in a fire, explosion, or other hazard, if known;</text></subparagraph><subparagraph id="HC0A51FE3537844B3B56EDE18A2EB88C6"><enum>(C)</enum><text>whether a lithium-ion battery involved in a fire, explosion, or other hazard complied with the standard required by this section, if known; and</text></subparagraph><subparagraph id="HADE2694B6B584846B0366F73A3AEC6DF"><enum>(D)</enum><text>if known, the manufacturer and country of manufacture of a lithium-ion battery that resulted in a fire, explosion, or other hazard.</text></subparagraph></paragraph></subsection></section></title><title id="H4E1134B9F9C84965BFF3290FF57422F0" style="OLC"><enum>III</enum><header>Foreign Adversary Communications Transparency Act</header><section id="H6AA5558515364F0EAB12E9797113A863"><enum>301.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Foreign Adversary Communications Transparency Act</quote>.</text></section><section id="H1FA46AF688E34550A040FB3D7E9C647F"><enum>302.</enum><header>List of entities holding FCC authorizations, licenses, or other grants of authority and having certain foreign ownership</header><subsection id="H50F9C788E59C403CB7B05E236EC93CE1" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 120 days after the date of the enactment of this Act, the Commission shall publish on the internet website of the Commission a list of each entity—</text><paragraph id="H06E5AE23B3604ED28A2BEC2E7774B7C7" commented="no"><enum>(1)</enum><text display-inline="yes-display-inline">that holds a license issued by the Commission pursuant to—</text><subparagraph id="H4E14428CF48740B3B7541A79BA705AD2" commented="no"><enum>(A)</enum><text>section 309(j) of the Communications Act of 1934 (<external-xref legal-doc="usc" parsable-cite="usc/47/309">47 U.S.C. 309(j)</external-xref>); or</text></subparagraph><subparagraph id="HE75420AF95A3489D8E2E7B1708B1C5CB" commented="no"><enum>(B)</enum><text>the Act of May 27, 1921 (<external-xref legal-doc="usc" parsable-cite="usc/47/34">47 U.S.C. 34 et seq.</external-xref>; commonly known as the <quote>Cable Landing Licensing Act</quote>) and Executive Order 10530 (<external-xref legal-doc="usc" parsable-cite="usc/3/301">3 U.S.C. 301</external-xref> note; relating to the performance of certain functions vested in or subject to the approval of the President); and</text></subparagraph></paragraph><paragraph id="H73B9B6C4822748FD8A90569C13920772" commented="no"><enum>(2)</enum><text>with respect to which—</text><subparagraph id="H67D500114E4345AD8FBA8D3E797D6DD1" commented="no"><enum>(A)</enum><text>a covered entity holds an equity or voting interest that is required to be reported to the Commission under the ownership rules of the Commission; or</text></subparagraph><subparagraph id="HAC896DD87B6A460B948D6024AC45234E" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">an appropriate national security agency has determined that a covered entity exerts control, regardless of whether such covered entity holds an equity or voting interest as described in subparagraph (A).</text></subparagraph></paragraph></subsection><subsection id="H388142C923A743E3ADBEBE66B06AFF3A"><enum>(b)</enum><header>Rulemaking</header><paragraph id="HBC382A33140B40F9A55D138DC3BE39CE"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 18 months after the date of the enactment of this Act, the Commission shall issue rules to obtain information to identify each entity—</text><subparagraph id="HE2105A0AE83F40C8BBCF023F51F5EBDD"><enum>(A)</enum><text>that holds any authorization, license, or other grant of authority issued by the Commission (other than a license described in subsection (a)(1)); and</text></subparagraph><subparagraph id="HA473E2509F5F4CAD9EF9CAF56474B88E"><enum>(B)</enum><text display-inline="yes-display-inline">with respect to which a covered entity holds an equity or voting interest that is required to be reported to the Commission under the ownership rules of the Commission.</text></subparagraph></paragraph><paragraph id="H5F446069D836430D92CBA02317EA9787"><enum>(2)</enum><header>Placement on list</header><text>Not later than 1 year after the Commission issues the rules required by paragraph (1), the Commission shall place each entity described in such paragraph on the list published under subsection (a).</text></paragraph></subsection><subsection id="HE1D48DA854A845E8BE25A25C1E7E9289"><enum>(c)</enum><header>Paperwork Reduction Act exemption</header><text>A collection of information conducted or sponsored by the Commission to implement this section does not constitute a collection of information for the purposes of subchapter I of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/44/35">chapter 35</external-xref> of title 44, United States Code (commonly referred to as the <quote>Paperwork Reduction Act</quote>).</text></subsection><subsection id="H541F2875A37A42FE8FB9CEFD296E2DD7"><enum>(d)</enum><header>Annual updates</header><text>The Commission shall, not less frequently than annually, update the list published under subsection (a), including with respect to any entity required to be placed on such list by subsection (b)(2).</text></subsection><subsection id="H9D024F11DF7D434ABD4142507275B701"><enum>(e)</enum><header>Definitions</header><text>In this section:</text><paragraph id="H2CFF46ECDA1240A5974C7E9B8CF2AA8C"><enum>(1)</enum><header>Appropriate national security agency</header><text display-inline="yes-display-inline">The term <term>appropriate national security agency</term> has the meaning given such term in section 9 of the Secure and Trusted Communications Networks Act of 2019 (<external-xref legal-doc="usc" parsable-cite="usc/47/1608">47 U.S.C. 1608</external-xref>). </text></paragraph><paragraph id="H54EB1559505D48DBBBCAFE08D7DD779E"><enum>(2)</enum><header>Commission</header><text>The term <term>Commission</term> means the Federal Communications Commission.</text></paragraph><paragraph id="H9C3ECF63C48A4F1F93394E66F029B481"><enum>(3)</enum><header>Covered country</header><text display-inline="yes-display-inline">The term <term>covered country</term> means a country specified in section 4872(f)(2) of title 10, United States Code.</text></paragraph><paragraph id="H9711C94ABE714E128E4163A289E7BEE5"><enum>(4)</enum><header>Covered entity</header><text>The term <term>covered entity</term> means—</text><subparagraph id="H996F9B0635BF423DB9CB80606A5E988A"><enum>(A)</enum><text>the government of a covered country;</text></subparagraph><subparagraph id="HCD9703AC65F644E1A9BDB3CC74BB04E2"><enum>(B)</enum><text display-inline="yes-display-inline">an entity organized under the laws of a covered country; and</text></subparagraph><subparagraph id="HF05CD02B17A645FBB625424000A4C2F0" commented="no" display-inline="no-display-inline"><enum>(C)</enum><text>a subsidiary of an entity described in subparagraph (B), regardless of whether the subsidiary is organized under the laws of a covered country.</text></subparagraph></paragraph></subsection></section></title><title id="HBC71E4BFF9614E4C8EEFE0005A6ED892"><enum>IV</enum><header>Promoting Resilient Supply Chains</header><section id="HEA7F6BF1C23C4CF3BBD69C3613A0B309"><enum>401.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Promoting Resilient Supply Chains Act</quote>.</text></section><section id="HD7ECA5DD75C34661BA981468B579FD6B"><enum>402.</enum><header>Additional responsibilities of Assistant Secretary of Commerce for Industry and Analysis</header><text display-inline="no-display-inline">In addition to the responsibilities of the Assistant Secretary on the day before the date of the enactment of this Act, the Assistant Secretary shall have the following responsibilities:</text><paragraph id="HAE3E8853AF99408597194B5ABC5E5E17"><enum>(1)</enum><text>Promote the stability and resilience of critical supply chains and critical and emerging technologies that strengthen the national security of the United States.</text></paragraph><paragraph id="HBAA2F046EE1F433A94550A486A00E745"><enum>(2)</enum><text>Lead the Working Group established pursuant to section 403 and consult covered nongovernmental representatives, industry, institutions of higher education, and State and local governments in order to—</text><subparagraph id="H34958B9F6870440AA05B2F487B4DA9D8"><enum>(A)</enum><text>promote resilient critical supply chains; and</text></subparagraph><subparagraph id="H52F31C9B77EC4166BF4FEA02FD80A913"><enum>(B)</enum><text>identify, prepare for, and respond to supply chain shocks to—</text><clause id="H96D846BF38D543F59247589F7E8B221D"><enum>(i)</enum><text>critical industries;</text></clause><clause id="HFF4A66A5F3454C12A1E1C208D5858D89"><enum>(ii)</enum><text>critical supply chains; and</text></clause><clause id="H2CBB469807B04719BA6D64B3CB01F687"><enum>(iii)</enum><text>critical and emerging technologies.</text></clause></subparagraph></paragraph><paragraph id="H29FCBCFACFB04F8BAB182DCD7ADFBC8D"><enum>(3)</enum><text>Encourage the growth and competitiveness of United States production and manufacturing in the United States of emerging technologies.</text></paragraph><paragraph id="HD7CF611B284E4232A9234046B92F5BDE"><enum>(4)</enum><text>Assess the resilience, diversity, and strength of critical supply chains and critical and emerging technologies.</text></paragraph><paragraph id="HBF2FE9BD6D494BCA8E83E2A6CE2DD360"><enum>(5)</enum><text>In consultation with the Secretary of State and the United States Trade Representative, support the availability of critical goods from domestic manufacturers, domestic enterprises, and manufacturing operations in countries that are allies or key international partner nations.</text></paragraph><paragraph id="H889DD679E09848A284C85868C0ECDE32"><enum>(6)</enum><text>Assist the Federal Government in preparing for and responding to supply chain shocks to critical supply chains, including by improving flexible manufacturing capacities and capabilities in the United States.</text></paragraph><paragraph id="H5FD3FDA96BDB4135913FE4A1AE12211D"><enum>(7)</enum><text>Consistent with United States obligations under international agreements, encourage and incentivize the reduced reliance of domestic enterprises and domestic manufacturers on critical goods from countries that are described in section 407(2)(B).</text></paragraph><paragraph id="HEBA61B8CC59343AAB81091613E518552"><enum>(8)</enum><text display-inline="yes-display-inline">Encourage the relocation of manufacturing facilities that manufacture critical goods from countries that are described in section 407(2)(B) to the United States and countries that are allies or key international partner nations to strengthen the resilience, diversity, and strength of critical supply chains.</text></paragraph></section><section id="HB2284A31F6FB41C8899D4083A3F53D0D"><enum>403.</enum><header>Critical supply chain resilience working group</header><subsection id="HBFCEFD25D26649EBA51AEA3F03D491E9"><enum>(a)</enum><header>Establishment</header><text>Not later than 120 days after the date of the enactment of this Act, the Assistant Secretary shall establish a working group to be known as the <quote>Supply Chain Resilience Working Group</quote> (in this title referred to as the <quote>Working Group</quote>) composed of the Federal agencies that rely upon the Industry and Analysis Business unit analysis, including agencies enumerated in subsection (c).</text></subsection><subsection id="HAAE344506D094922A7DD88CF4A10C920"><enum>(b)</enum><header>Activities</header><text>Not later than 1 year after the date of the enactment of this Act, the Assistant Secretary shall carry out the following activities:</text><paragraph id="HFA104814EBDE4F068ACB109DE47E699E"><enum>(1)</enum><text>In consultation with the Working Group—</text><subparagraph id="HC9A4E0B82D6443769937FD76C1C4288D"><enum>(A)</enum><text>assessing, mapping, and modeling critical supply chains, including for critical and emerging technologies, which may include—</text><clause id="H9375FBF8532E4357A98E343AD75A6EFB"><enum>(i)</enum><text>modeling the impact of supply chain shocks on critical industries (including for critical and emerging technologies), and critical supply chains;</text></clause><clause id="HA18DEBD888A742FFA04375C7062F9CFB"><enum>(ii)</enum><text>assessing the demand for and supply of critical goods, production equipment, and manufacturing technology needed for critical supply chains, including critical goods, production equipment, and manufacturing technology obtained by or purchased from a person outside of the United States or imported into the United States; and</text></clause><clause id="H99F99D5A2513479DA987FB7625B34AA4"><enum>(iii)</enum><text>assessing manufacturing, warehousing, transportation, and distribution related to critical supply chains;</text></clause></subparagraph><subparagraph id="HF7BDDD84487E4CF99D4C422CB27D53A4"><enum>(B)</enum><text>identifying high priority gaps and vulnerabilities in critical supply chains and critical industries (including critical industries for critical and emerging technologies) that—</text><clause id="HE5664C1A74474051B8ADD371B68B096D"><enum>(i)</enum><text>exist as of the date of the enactment of this Act; or</text></clause><clause id="HB562B1622E764516B3ACCA65FB72320F"><enum>(ii)</enum><text>are anticipated to occur after the date of the enactment of this Act;</text></clause></subparagraph><subparagraph id="HAECF2F0426834267AB40BA3BA1997311"><enum>(C)</enum><text>identifying potential supply chain shocks to a critical supply chain that may disrupt, strain, or eliminate the critical supply chain;</text></subparagraph><subparagraph id="HAF1A128C2DC142159961223A24AC8766"><enum>(D)</enum><text>evaluating the capability and capacity of domestic manufacturers or manufacturers located in countries that are allies or key international partner nations to serve as sources for critical goods, production equipment, or manufacturing technology needed in critical supply chains;</text></subparagraph><subparagraph id="H485F7147BD9741B392A64E26540EAF78"><enum>(E)</enum><text>evaluating the effect on market stability that may result from the disruption, strain, or elimination of a critical supply chain;</text></subparagraph><subparagraph id="H437C242E0EED460F946B7ED61B2BFB3E"><enum>(F)</enum><text>evaluating the state of the manufacturing workforce, including by—</text><clause id="H058C2B956D6E414B8DAAC50C638FA86F"><enum>(i)</enum><text>identifying the needs of domestic manufacturers; and</text></clause><clause id="H4E23C9586462497AA2944E4748C925F5"><enum>(ii)</enum><text>identifying opportunities to create high-quality manufacturing jobs; and</text></clause></subparagraph><subparagraph id="H7CA84BAB565B4903B5986B709E37FFDA"><enum>(G)</enum><text>identifying and describing necessary tools, including commercially available risk assessment tools, that leverage data and industry expertise to provide insights into critical supply chain vulnerabilities, including how such tools fulfill the requirements described in subparagraphs (A) through (F).</text></subparagraph></paragraph><paragraph id="HA6657CFF763944F3A2DB04BFFCF7FD80"><enum>(2)</enum><text>In consultation with State and local governments, the Working Group, and (as appropriate) countries that are allies or key international partner nations—</text><subparagraph id="HB4EF02DF3A9141408B65632092B66B40"><enum>(A)</enum><text>identifying opportunities to reduce gaps and vulnerabilities in critical supply chains and critical industries;</text></subparagraph><subparagraph id="HE1DC7FFEDAE141A4AECB5B49219960F1"><enum>(B)</enum><text>encouraging consultation between the Federal Government, industry, covered nongovernmental representatives, institutions of higher education, and State and local governments to—</text><clause id="HE6995822D0E247A399B0626F3264CEF5"><enum>(i)</enum><text>better respond to supply chain shocks to critical supply chains and critical industries (including critical industries for emerging technologies); and</text></clause><clause id="H6575B2844E844F02BB8A37E8E9B63657"><enum>(ii)</enum><text>coordinate response efforts to supply chain shocks;</text></clause></subparagraph><subparagraph id="H60ECB052F40F4191BE6D371C6D3DD283"><enum>(C)</enum><text>encouraging consultation between the Federal Government and the governments of countries that are allies or key international partner nations;</text></subparagraph><subparagraph id="H9522CC7BF2774B169F9B3D9E53418CB5"><enum>(D)</enum><text>identifying opportunities to build the capacity of the United States in critical supply chains, critical industries, and emerging technologies;</text></subparagraph><subparagraph id="HEAE6FC6058C8466CA6DA034ADC394F65"><enum>(E)</enum><text>identifying opportunities to build the capacity of countries that are allies or key international partner nations in critical industries (including critical industries for emerging technologies) and critical supply chains; and</text></subparagraph><subparagraph id="HADC6B40016934C238C2E5EF7410F0C0A"><enum>(F)</enum><text>developing and assessing contingency plans and coordination mechanisms to improve the response of critical supply chains and critical industries to supply chain shocks.</text></subparagraph></paragraph></subsection><subsection id="HFDF31B31A5D448918550EC44033434F3"><enum>(c)</enum><header>Working Group membership</header><text>The Working Group shall include a representative from each Federal agency that relies on the analysis of the Industry and Analysis business unit, including—</text><paragraph id="HA028E586ACA64906B5741FAB84ED3BAE"><enum>(1)</enum><text>the Department of State;</text></paragraph><paragraph id="H418B9E75CD7148EFB8994E7CE97671E4"><enum>(2)</enum><text>the Department of Defense;</text></paragraph><paragraph id="HC45BF272326D48CEB95759761EBB9B52"><enum>(3)</enum><text>the Department of Homeland Security;</text></paragraph><paragraph id="HA389F1F619C54727A363132D8DBAB01D"><enum>(4)</enum><text>the Department of Transportation;</text></paragraph><paragraph id="HF272A9978A66469EB6225D1B37E0FD17"><enum>(5)</enum><text>the Department of Energy;</text></paragraph><paragraph id="H302AF2D1122E420F98D729FF577F6CAA"><enum>(6)</enum><text>the Department of Agriculture;</text></paragraph><paragraph id="H697AC34229E145AEB15E1FF8D353F752"><enum>(7)</enum><text>the Department of the Interior;</text></paragraph><paragraph id="HE5D944C2FB594440BE978AE82F7ED248"><enum>(8)</enum><text>the Department of Health and Human Services;</text></paragraph><paragraph id="H27D6E3BAD2204F52B6284477DA1F49D8"><enum>(9)</enum><text>the Office of the Director of National Intelligence; and</text></paragraph><paragraph id="H75BBA05A570D4F6DBA85C0BA7F8A7121"><enum>(10)</enum><text>the Small Business Administration.</text></paragraph></subsection><subsection id="HC6FD7A270E214CD89CF5F2744125030D"><enum>(d)</enum><header>Designations</header><text>The Assistant Secretary shall—</text><paragraph id="H27A8418196624B70B9708EA9D7BAA7DB"><enum>(1)</enum><text>not later than 120 days after the date of the enactment of this Act, designate—</text><subparagraph id="HFEA61B228D1F4426906CF58CD3A129DF"><enum>(A)</enum><text>critical industries;</text></subparagraph><subparagraph id="H51EB4B4451B04BA89B70B971BE439B06"><enum>(B)</enum><text>critical supply chains; and</text></subparagraph><subparagraph id="H7197B7326DC14F46BF0B7518DE086149"><enum>(C)</enum><text>critical goods;</text></subparagraph></paragraph><paragraph id="H071B94727E524478A32410215295244D"><enum>(2)</enum><text>provide for a period of public comment and review in carrying out paragraph (1); and</text></paragraph><paragraph id="HD8A0AF2E622C4F32B87F077FD9D8AB2A"><enum>(3)</enum><text>update the designations made pursuant to paragraph (1) not less frequently than once every 4 years, including designations for technologies that are not described in section 407(12)(B) that the Assistant Secretary considers necessary.</text></paragraph></subsection><subsection id="HCF2FA00EE47B4F5F805A17004FE72E24"><enum>(e)</enum><header>Implementation report</header><text>Not later than 1 year after the date of the enactment of this Act, the Assistant Secretary shall submit to the relevant committees of Congress a report that—</text><paragraph id="HDE00C8EBA8794F64931322AE3B9C09E4"><enum>(1)</enum><text>details supply chain activities, including applicable activities described in subsection (b) and responsibilities described in section 402, that the Assistant Secretary has conducted over the past year;</text></paragraph><paragraph id="H9EB94F5726A946149B882ED0EBFB396D"><enum>(2)</enum><text>describes supply chain data collected, retained, and analyzed by the Assistant Secretary over the past year;</text></paragraph><paragraph id="H1EB70285B4F64F83AED7DFA170122CF3"><enum>(3)</enum><text>identifies and describes necessary tools, including commercially available risk assessment tools, that leverage data and industry expertise to provide insights into critical supply chain vulnerabilities, including how such tools fulfill each responsibility described in subsection (b);</text></paragraph><paragraph id="H246283C08C924746B170220E942E6B03"><enum>(4)</enum><text>identifies and describes all Federal agencies with authorities or responsibilities described in subsection (b); and</text></paragraph><paragraph id="HF0842D9D32A343479A29B78BF7BF5E26"><enum>(5)</enum><text>identifies Federal agencies, programs, and bureaus with duplicative purposes to fulfill any of the authorities or responsibilities described in subsection (b).</text></paragraph></subsection><subsection id="H79BFF6D7592242AAA91147F17352015D"><enum>(f)</enum><header>National strategy and review on critical supply chain resiliency and manufacturing in the United States</header><paragraph id="H6E3C387C2CB74285919F16C8E3695567"><enum>(1)</enum><header>In general</header><text>Not later than 18 months after the date of the enactment of this Act, and annually thereafter, the Assistant Secretary, in consultation with the Working Group, covered nongovernmental representatives, industries, institutions of higher education, and State and local governments, shall submit to the relevant committees of Congress a report that—</text><subparagraph id="H9544501D6E8D4F9CBD573F9C16FBFABE"><enum>(A)</enum><text>identifies—</text><clause id="H54C4F06CBC644D9E94DE98D332F0A113"><enum>(i)</enum><text>critical infrastructure that may assist in fulfilling the responsibilities described in section 402;</text></clause><clause id="HD7AFBD5D860D40F9B2054B0EFB9B94DA"><enum>(ii)</enum><text>critical and emerging technologies that may assist in fulfilling the responsibilities described in section 402, including such technologies that may be critical to addressing preparedness, weaknesses, and vulnerabilities relating to critical supply chains;</text></clause><clause id="H246E1EC1F0FE497A84E9585ECD34C768"><enum>(iii)</enum><text>critical industries, critical supply chains, and critical goods designated pursuant to subsection (d);</text></clause><clause id="H113E315BC8734961A12D9B56158B818A"><enum>(iv)</enum><text>other supplies and services that are critical to the crisis preparedness of the United States;</text></clause><clause id="H8D463AD3347A413C9522D90A694524F3"><enum>(v)</enum><text>substitutes for critical goods, production equipment, and manufacturing technology;</text></clause><clause id="H9521342F8DF64929AA7268817EA4288F"><enum>(vi)</enum><text>methods and technologies, including blockchain technology, distributed ledger technology, and other critical and emerging technologies, as appropriate, for the authentication and traceability of critical goods; and</text></clause><clause id="HDF565CEAF2834859822725D88FB20AA9"><enum>(vii)</enum><text>countries that are allies or key international partner nations;</text></clause></subparagraph><subparagraph id="HE24C7F00C66946A48EFB402C21DB7E34"><enum>(B)</enum><text>describes the matters identified and evaluated under subsection (b)(1), including—</text><clause id="HE53AE0EFA21F446EB8EC3EF3585E22C4"><enum>(i)</enum><text>the manufacturing base, critical supply chains, and emerging technologies in the United States, including the manufacturing base and critical supply chains for—</text><subclause id="HF86AF414D16D49EA91204FCBCB696D4D"><enum>(I)</enum><text>critical goods;</text></subclause><subclause id="H3C2D99A27B2C437FAA0819DF4660E1D8"><enum>(II)</enum><text>production equipment; and</text></subclause><subclause id="HD39954344BB448F8AABAEA3AC7E51853"><enum>(III)</enum><text>manufacturing technology; and</text></subclause></clause><clause id="H04EBDCB93F5A4C118E2D04BE56E5C92B"><enum>(ii)</enum><text>the ability of the United States to—</text><subclause id="HF60BD7AACCF74A00B999C17D48B51BB2"><enum>(I)</enum><text>maintain readiness with respect to preparing for and responding to supply chain shocks; and</text></subclause><subclause id="H68E15002ECFF4DC08F0EEB5307A630DB"><enum>(II)</enum><text>in response to a supply chain shock—</text><item id="H3768863C7F9143ECB40BD9BA24A56DEB"><enum>(aa)</enum><text>surge production in critical industries;</text></item><item id="H766853DEC92245D2B0ABED7D53DAE68C"><enum>(bb)</enum><text>surge production of critical goods and production equipment; and</text></item><item id="H0E3DCE014DD746FA9E9C0DC889871557"><enum>(cc)</enum><text>maintain access to critical goods, production equipment, and manufacturing technology;</text></item></subclause></clause></subparagraph><subparagraph id="HCCE7ABAD6A314E3090E8351B67A48B6C"><enum>(C)</enum><text>assesses and describes—</text><clause id="H7B942C0F03D042768082402ED5F5C9E5"><enum>(i)</enum><text>the demand and supply of critical goods, production equipment, and manufacturing technology;</text></clause><clause id="H2861032176A14DB7840451900C0A5FB7"><enum>(ii)</enum><text>the production of critical goods, production equipment, and manufacturing technology by domestic manufacturers;</text></clause><clause id="H3DAEFB6044F747448FAC1A6ED6A9E874"><enum>(iii)</enum><text>the capability and capacity of domestic manufacturers and manufacturers in countries that are allies or key international partner nations to manufacture critical goods, production equipment, and manufacturing technology; and</text></clause><clause id="H1CE60CA7957B4DEBA79B39BBB6EF95FE"><enum>(iv)</enum><text>how supply chain shocks could affect rural, Tribal, and underserved communities;</text></clause></subparagraph><subparagraph id="HB0DD4C6196EF443893830B28469EC63A"><enum>(D)</enum><text>identifies threats and supply chain shocks that may disrupt, strain, or eliminate critical supply chains, critical goods, and critical industries (including critical industries for emerging technologies);</text></subparagraph><subparagraph id="H0A0A56AE66F54349B073279CF053004D"><enum>(E)</enum><text display-inline="yes-display-inline">with regard to any threat identified under subparagraph (D), lists any threat or supply chain shock that may originate from a country, or a company or individual from a country, that is described in section 407(2)(B);</text></subparagraph><subparagraph id="H569B2EC3484E4792AB23914D7B64009C"><enum>(F)</enum><text>assesses—</text><clause id="H24EE85B59FA7426E8E4B21C0EF0E7564"><enum>(i)</enum><text>the resilience and capacity of the manufacturing base, critical supply chains, and workforce of the United States and countries that are allies or key international partner nations that can sustain critical industries (including critical industries for emerging technologies) through a supply chain shock; and</text></clause><clause id="H76C55FBC1B6C43F8B83E4381AB71EF1E"><enum>(ii)</enum><text>the effect innovation has on domestic manufacturers;</text></clause></subparagraph><subparagraph id="H5BEB19E5E2A94FBB9AAC2C865031AA42"><enum>(G)</enum><text>assesses the flexible manufacturing capacity and capability available in the United States in the case of a supply chain shock; and</text></subparagraph><subparagraph id="HDFE0E59879E541A28C20E552661C96DD"><enum>(H)</enum><text>develops a strategy for the Department of Commerce to support the resilience, diversity, and strength of critical supply chains and critical and emerging technologies to—</text><clause id="HD8ABF4A321DC4AB28B347184424BBA83"><enum>(i)</enum><text display-inline="yes-display-inline">support sufficient access to critical goods by mitigating vulnerabilities in critical supply chains, including critical supply chains concentrated in countries that are described in section 407(2)(B);</text></clause><clause id="H7D52BD4F36064C5A97DA80356E7C3692"><enum>(ii)</enum><text>consult with other relevant agencies to assist countries that are allies or key international partner nations in building capacity for manufacturing critical goods;</text></clause><clause id="H3CAC1BE6AE914D30B265BFD5908B6292"><enum>(iii)</enum><text>recover from supply chain shocks;</text></clause><clause id="H52630CD843DA4CE1AFAC93EEBA8A34CD"><enum>(iv)</enum><text>identify, in consultation with the Working Group and other relevant agencies, actions relating to critical supply chains or emerging technologies that the United States may take to improve responses to supply chain shocks;</text></clause><clause id="HED20A3CEF30144B589DF8FE16D117BEC"><enum>(v)</enum><text display-inline="yes-display-inline">protect against supply chain shocks relating to critical supply chains from countries that are described in section 407(2)(B); and</text></clause><clause id="H572C0A8C85E04E4D9BE6F129CE746A86"><enum>(vi)</enum><text>make specific recommendations to implement the strategy under this section and improve the security and resiliency of manufacturing capacity and supply chains for critical industries (including critical industries for emerging technologies) by—</text><subclause id="HECD62B273C52442A915FB8E9030879BE"><enum>(I)</enum><text>developing long-term strategies;</text></subclause><subclause id="H5DA9AFB84660410B8F64F7F09FC10DCC"><enum>(II)</enum><text>increasing visibility into the networks and capabilities of domestic manufacturers and suppliers of domestic manufacturers;</text></subclause><subclause id="HB0A601265A6E4C468C46F1143F572028" display-inline="no-display-inline"><enum>(III)</enum><text>identifying and mitigating risks, including—</text><item id="HFFDC8A0F7AF44475AE6DA38BB142CCCB"><enum>(aa)</enum><text>significant vulnerabilities to supply chain shocks; and</text></item><item id="H4D024A271E394F88B2599E4D001896B4"><enum>(bb)</enum><text>exposure to gaps and vulnerabilities in domestic capacity or capabilities and sources of imports needed to sustain critical industries (including critical industries for emerging technologies) or critical supply chains;</text></item></subclause><subclause id="H51A5581F841F43AE8101CEE0B016B481"><enum>(IV)</enum><text>identifying opportunities to reuse and recycle critical goods, including raw materials, to increase resilient critical supply chains;</text></subclause><subclause id="H4C620D8AE95D43D9B973B3063D0E821C"><enum>(V)</enum><text>consulting with countries that are allies or key international partner nations on—</text><item id="H128BA2A884A146BBA752C61EE87A2AFD"><enum>(aa)</enum><text>sourcing critical goods, production equipment, and manufacturing technology; and</text></item><item id="H239B12C9D36A4A77A7FC16D72C790222"><enum>(bb)</enum><text>developing, sustaining, and expanding production and availability of critical goods, production equipment, and manufacturing technology during a supply chain shock; and</text></item></subclause><subclause id="H01603921B1164312BC8CB484E3525E72"><enum>(VI)</enum><text>providing guidance to other relevant agencies with respect to critical goods, supply chains, and critical industries (including critical industries for emerging technologies) that should be prioritized to support United States leadership in the deployment of such technologies.</text></subclause></clause></subparagraph></paragraph><paragraph id="H19FD0D1E92FA42E499BDA63F3D3EBA9B"><enum>(2)</enum><header>Prohibition</header><text>The report submitted pursuant to paragraph (1) may not include—</text><subparagraph id="H9E9E298364314E1788E1B072FA73703C"><enum>(A)</enum><text>critical supply chain information that is not aggregated;</text></subparagraph><subparagraph id="HA4223B205F554985A6BA98482CD8B019"><enum>(B)</enum><text>confidential business information of a private sector entity; or</text></subparagraph><subparagraph id="H3970D86B2227478DBFE8352EB0FC497B"><enum>(C)</enum><text>classified information.</text></subparagraph></paragraph><paragraph id="HA719CBC93CBA42EB9C1FFBE18118381C"><enum>(3)</enum><header>Form</header><text>The report submitted pursuant to paragraph (1), and any update submitted thereafter, shall be submitted to the relevant committees of Congress in unclassified form and may include a classified annex.</text></paragraph><paragraph id="H1583D004CF4943F0B709AA5CBD7045E7"><enum>(4)</enum><header>Public comment</header><text>The Assistant Secretary shall provide for a period of public comment and review in developing the report submitted pursuant to paragraph (1).</text></paragraph></subsection><subsection id="H80E7FA1FA853449185C9DA3A8D08248E"><enum>(g)</enum><header>Consultation</header><text>Not later than 1 year after the date of the enactment of this Act, the Assistant Secretary shall enter into an agreement with the head of any relevant agency to obtain any information, data, or assistance that the Assistant Secretary determines necessary to conduct the activities described in subsection (b).</text></subsection><subsection id="H25691E9B43CD4FBFBA143A6FCE34D11D"><enum>(h)</enum><header>Rule of construction</header><text>Nothing in this section may be construed to require any private entity—</text><paragraph id="H3200DD344B9245E2BE7473AF4BED0120"><enum>(1)</enum><text>to share information with the Secretary or Assistant Secretary;</text></paragraph><paragraph id="HFB83E22F133F42F6B24D6008EC958F22"><enum>(2)</enum><text>to request assistance from the Secretary or Assistant Secretary; or</text></paragraph><paragraph id="HDD726D6460154EE484F9F75ED41BF39D"><enum>(3)</enum><text>to implement any measure or recommendation suggested by the Secretary or Assistant Secretary in response to a request by the private entity.</text></paragraph></subsection><subsection id="HD8BB24FBBB5C427CA1786369559E5730"><enum>(i)</enum><header>Protection of voluntarily shared critical supply chain information</header><paragraph id="H930D445CB521482A8FD1DA630DF176B2"><enum>(1)</enum><header>Protection</header><subparagraph id="H0379A4437A304FF59FCD40796183D2DE"><enum>(A)</enum><header>In general</header><text>Notwithstanding any other provision of law, critical supply chain information (including the identity of the submitting person or entity) that is voluntarily submitted under this section to the Department of Commerce for use by the Department for purposes of this section, when accompanied by an express statement described in subparagraph (B)—</text><clause id="H2E2E6960ED4B4F1EA2D6D7E307924B10"><enum>(i)</enum><text>shall be exempt from disclosure under section 552(b)(3) of title 5, United States Code (commonly referred to as the <quote>Freedom of Information Act</quote>);</text></clause><clause id="H81A204EB1B6F4D22840B050D57617D86"><enum>(ii)</enum><text>is not subject to any agency rules or judicial doctrine regarding ex parte communications with a decision-making official;</text></clause><clause id="HA0EE8ED016BB4D67941AF4337CCF306C"><enum>(iii)</enum><text>may not, without the written consent of the person or entity submitting such information, be used directly by the Department of Commerce, any other Federal, State, or local authority, or any third party, in any civil action arising under Federal or State law if such information is submitted in good faith;</text></clause><clause id="HEAF9FEAB1F24486CB1C941A006FFE2AA"><enum>(iv)</enum><text>may not, without the written consent of the person or entity submitting such information, be used or disclosed by any officer or employee of the United States for purposes other than the purposes of this section, except—</text><subclause id="H216494D8289840DBA62B76A8DA36DCA6"><enum>(I)</enum><text>in furtherance of an investigation or the prosecution of a criminal act; or</text></subclause><subclause id="H666A77A5C8034E86ABEB39A67C767E81"><enum>(II)</enum><text>when disclosure of the information would be—</text><item id="H7160A0DD6A7F4D2193C2D8BE44A6EAB1"><enum>(aa)</enum><text>to either House of Congress, or to the extent of matter within its jurisdiction, any committee or subcommittee thereof, any joint committee thereof, or any subcommittee of any such joint committee; or</text></item><item id="HEE690461DEC345869FDD0FC944682D1E"><enum>(bb)</enum><text>to the Comptroller General of the United States, or any authorized representative of the Comptroller General, in the course of the performance of the duties of the Government Accountability Office;</text></item></subclause></clause><clause id="H9B2D891903724447A0ABCDD44A6832E6"><enum>(v)</enum><text>may not, if provided to a State or local government or government agency—</text><subclause id="H7FB32F8D1D86446D9C35FB1E916A8A92"><enum>(I)</enum><text>be made available pursuant to any State or local law requiring disclosure of information or records;</text></subclause><subclause id="HD2A47B5DF7E045B58FE407C32D61E687"><enum>(II)</enum><text>otherwise be disclosed or distributed to any party by such State or local government or government agency without the written consent of the person or entity submitting such information; or</text></subclause><subclause id="HBEE05AC087F048849EEBB281FFFFB329"><enum>(III)</enum><text>be used other than for the purpose of carrying out this section, or in furtherance of an investigation or the prosecution of a criminal act; and</text></subclause></clause><clause id="H8A7CD563291D4921896DBE2E7D66E501"><enum>(vi)</enum><text>does not constitute a waiver of any applicable privilege or protection provided under law, such as trade secret protection.</text></clause></subparagraph><subparagraph id="H6E29D605149A4F6FB764657FEEA8C345"><enum>(B)</enum><header>Express statement</header><text>The express statement described in this subparagraph, with respect to information or records, is—</text><clause id="HC56D7B01A8F24B0E96EE7FCF9132E90C"><enum>(i)</enum><text>in the case of written information or records, a written marking on the information or records substantially similar to the following: <quote>This information is voluntarily submitted to the Federal Government in expectation of protection from disclosure as provided by the provisions of the Promoting Resilient Supply Chains Act.</quote>; or</text></clause><clause id="H27B77EF9B4F14C5ABFFC2F44BE1EBF1C"><enum>(ii)</enum><text>in the case of oral information, a written statement similar to the statement described in clause (i) submitted within a reasonable period following the oral communication.</text></clause></subparagraph></paragraph><paragraph id="HD3D21939093B41F3B2E59140720E3BA5"><enum>(2)</enum><header>Limitation</header><text>No communication of critical supply chain information to the Department of Commerce made pursuant to this section may be considered to be an action subject to the requirements of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/10">chapter 10</external-xref> of title 5, United States Code.</text></paragraph><paragraph id="HA202FA722E2443789EDB59847DED2DF8"><enum>(3)</enum><header>Independently obtained information</header><text>Nothing in this subsection may be construed to limit or otherwise affect the ability of a State, local, or Federal Government entity, agency, or authority, or any third party, under applicable law to obtain critical supply chain information in a manner not covered by paragraph (1), including any information lawfully and properly disclosed generally or broadly to the public and to use such information in any manner permitted by law. For purposes of this subsection, a permissible use of independently obtained information includes the disclosure of such information under section 2302(b)(8) of title 5, United States Code.</text></paragraph><paragraph id="HBB5DCE0B903741DA8C541994D9B624A9"><enum>(4)</enum><header>Treatment of voluntary submittal of information</header><text>The voluntary submittal to the Department of Commerce of information or records that are protected from disclosure by this section may not be construed to constitute compliance with any requirement to submit such information to an agency under any other provision of law.</text></paragraph><paragraph id="H5CEFD785FB224495AD7593862DB9E759"><enum>(5)</enum><header>Inapplicability to semiconductor incentive program</header><text>This subsection does not apply to the voluntary submission of critical supply chain information in an application for Federal financial assistance under section 9902 of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (<external-xref legal-doc="public-law" parsable-cite="pl/116/283">Public Law 116–283</external-xref>).</text></paragraph></subsection></section><section id="HA08FCC8C8A88401B880BD7939DB8039E"><enum>404.</enum><header>Department of Commerce capability assessment</header><subsection id="H0CA4AE3FE6BA41DCB204209420BA51E3"><enum>(a)</enum><header>Report required</header><text>The Secretary shall produce a report—</text><paragraph id="H6CEFCD29B41E4B11863DEC6E8F6FDDC6"><enum>(1)</enum><text>identifying the duties, responsibilities, resources, programs, and expertise within the offices and bureaus of the Department of Commerce relevant to critical supply chain resilience and manufacturing innovation;</text></paragraph><paragraph id="H26AFCF22452143868A806E849F33C05E"><enum>(2)</enum><text>identifying and assessing the purpose, legal authority, effectiveness, efficiency, and limitations of each office or bureau identified under paragraph (1); and</text></paragraph><paragraph id="H034996ACA7D64DD286B4D6558CE5F247"><enum>(3)</enum><text>providing recommendations to enhance the activities related to critical supply chain resilience and manufacturing innovation of the Department of Commerce, including—</text><subparagraph id="HD6E06DCC6ADA43108992BE00E7C7A6CC"><enum>(A)</enum><text>improving the effectiveness, efficiency, and impact of the offices and bureaus identified under paragraph (1);</text></subparagraph><subparagraph id="H4652BDE1C88D4F56AC7C95B0DDEBA5FD"><enum>(B)</enum><text>coordinating across offices and bureaus identified under paragraph (1); and</text></subparagraph><subparagraph id="H50BE4965C27944CCB115B6FC902B17D9"><enum>(C)</enum><text>consulting with agencies implementing similar activities related to critical supply chain resilience and manufacturing innovation.</text></subparagraph></paragraph></subsection><subsection id="H5634EB7B38E34ED98BAD4305BC294A2B"><enum>(b)</enum><header>Submission of report</header><text>Not later than 2 years after the date of the enactment of this Act, the Secretary shall submit to the relevant committees of Congress the report required by subsection (a), along with a strategy to implement, as appropriate and as determined by the Secretary, the recommendations contained in the report.</text></subsection></section><section id="HBDEA6DD0DFEE40B2A5A0C822271ACB07"><enum>405.</enum><header>No additional funds</header><text display-inline="no-display-inline">No additional funds are authorized to be appropriated to carry out this title.</text></section><section id="H26418551BE83445292AF6D449634E39D"><enum>406.</enum><header>Sunset</header><text display-inline="no-display-inline">This title and all requirements, responsibilities, and obligations under this title shall terminate on the date that is 10 years after the date of the enactment of this Act.</text></section><section id="HE534C6C77A824E66AB4294583382368F"><enum>407.</enum><header>Definitions</header><text display-inline="no-display-inline">In this title:</text><paragraph id="H990AB4A0E94F4A02BFC92680DF71BB21"><enum>(1)</enum><header>Agency</header><text>The term <term>agency</term> has the meaning given that term in section 551 of title 5, United States Code.</text></paragraph><paragraph id="H0DBB11E3403F4D4FB87E33BB52768213"><enum>(2)</enum><header>Ally or key international partner nation</header><text>The term <term>ally or key international partner nation</term>—</text><subparagraph id="HB8326691FEAF489A82D84B5127AB7204"><enum>(A)</enum><text>means a country that is critical to addressing critical supply chain weaknesses and vulnerabilities; and</text></subparagraph><subparagraph id="H602C0492A5DB430A95972E2E5C1721CA"><enum>(B)</enum><text>does not include—</text><clause id="H5D042B24E9F8432E86C38ED9029D6EE4"><enum>(i)</enum><text>a country that poses a significant risk to the national security or economic security of the United States; or</text></clause><clause id="H2DBE9A4F25714A748F272AE792CADE19"><enum>(ii)</enum><text>a country that is described in section 503(b) of the RANSOMWARE Act (title V of division BB of the Consolidated Appropriations Act, 2023; <external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref>; 136 Stat. 5564).</text></clause></subparagraph></paragraph><paragraph id="H1B62A8F1A2BD4DC095BADD77C6B29FCA"><enum>(3)</enum><header>Assistant Secretary</header><text>The term <term>Assistant Secretary</term> means the Assistant Secretary of Commerce assigned by the Secretary to direct the office of Industry and Analysis.</text></paragraph><paragraph id="HD0910C6FA28342C790726D208C8CEBDE"><enum>(4)</enum><header>Covered nongovernmental representative</header><text>The term <term>covered nongovernmental representative</term> means a representative as specified in the second sentence of section 135(b)(1) of the Trade Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/19/2155">19 U.S.C. 2155(b)(1)</external-xref>), except that such term does not include a representative of a non-Federal government.</text></paragraph><paragraph id="HB6ACE2F7E0FF46BE819175A9F04E627B"><enum>(5)</enum><header>Critical good</header><text>The term <term>critical good</term> means any raw, in process, or manufactured material (including any mineral, metal, or advanced processed material), article, commodity, supply, product, or item for which an absence of supply would have a debilitating impact on—</text><subparagraph id="HFD98BC309E10450E9984438368F8148D"><enum>(A)</enum><text>the national security or economic security of the United States; and</text></subparagraph><subparagraph id="H0FB67190BFAB430AB62B8CBF3AEB88B5"><enum>(B)</enum><text>either—</text><clause id="H758C9EB4085C4310A35E432662A8FB0D"><enum>(i)</enum><text>critical infrastructure; or</text></clause><clause id="H09C18CE738464EE29DF8DCB31A964AE7"><enum>(ii)</enum><text>an emerging technology.</text></clause></subparagraph></paragraph><paragraph id="HDFC3ACD815784C43899CED24329B82C5"><enum>(6)</enum><header>Critical industry</header><text>The term <term>critical industry</term> means an industry that—</text><subparagraph id="HFE0CA8639EA64B118A697FF8B93A9BFC"><enum>(A)</enum><text>is critical for the national security or economic security of the United States; and</text></subparagraph><subparagraph id="H8ECAF0156F2340B4968688A9A8FDA6A6"><enum>(B)</enum><text>produces or procures a critical good.</text></subparagraph></paragraph><paragraph id="HAD010EF9A86748BE96CF274E30927C84"><enum>(7)</enum><header>Critical infrastructure</header><text>The term <term>critical infrastructure</term> has the meaning given that term in section 1016 of the Critical Infrastructures Protection Act of 2001 (<external-xref legal-doc="usc" parsable-cite="usc/42/5195c">42 U.S.C. 5195c</external-xref>).</text></paragraph><paragraph id="H42638445E4EF4C1D81918563B7F08A8B"><enum>(8)</enum><header>Critical supply chain</header><text>The term <term>critical supply chain</term> means a supply chain for a critical good.</text></paragraph><paragraph id="H6D615DF8B805486FBDAE44859E52EC47"><enum>(9)</enum><header>Critical supply chain information</header><text>The term <term>critical supply chain information</term> means information that is not customarily in the public domain and relates to—</text><subparagraph id="H51E5850667D94AA0B9E293190F074EF1"><enum>(A)</enum><text>sustaining and adapting a critical supply chain during a supply chain shock;</text></subparagraph><subparagraph id="H06CAA067021147EB946A646A74391889"><enum>(B)</enum><text>critical supply chain risk mitigation and recovery planning with respect to a supply chain shock, including any planned or past assessment, projection, or estimate of a vulnerability within the critical supply chain, including testing, supplier network assessments, production flexibility, supply chain risk evaluations, supply chain risk management planning, or risk audits; or</text></subparagraph><subparagraph id="H5442BED2DF404505ADBF0C3A801FFF54"><enum>(C)</enum><text>operational best practices, planning, and supplier partnerships that enable enhanced resilience of a critical supply chain during a supply chain shock, including response, repair, recovery, reconstruction, insurance, or continuity.</text></subparagraph></paragraph><paragraph id="H16B3599DBAE343C6A8F3CF6AAA2DC83B"><enum>(10)</enum><header>Domestic enterprise</header><text>The term <term>domestic enterprise</term> means an enterprise that conducts business in the United States and procures a critical good.</text></paragraph><paragraph id="HCCFBBF8ABAAC4D438D4300E143BA5FDF"><enum>(11)</enum><header>Domestic manufacturer</header><text>The term <term>domestic manufacturer</term> means a business that conducts in the United States the research and development, engineering, or production activities necessary for manufacturing a critical good.</text></paragraph><paragraph id="H90BC8538FBAA424B91A49F9C0396B64A"><enum>(12)</enum><header>Emerging technology</header><text>The term <term>emerging technology</term> means a technology that is critical for the national security or economic security of the United States, including the following:</text><subparagraph id="HBAC20514383245568FF29265AFA4D4A8"><enum>(A)</enum><text>Technologies included in the American COMPETE Act (title XV of division FF of the Consolidated Appropriations Act, 2021; <external-xref legal-doc="public-law" parsable-cite="pl/116/260">Public Law 116–260</external-xref>; 134 Stat. 3276).</text></subparagraph><subparagraph id="HDB719E9B6E48458BBEED7D3BA2E3CA61"><enum>(B)</enum><text>The following technologies:</text><clause id="H30A60B2C9DF346BBABD1564BDC0C9ACF"><enum>(i)</enum><text>Artificial intelligence.</text></clause><clause id="H56CC6BF9BB9D4106B0FC9B16E5CAA381"><enum>(ii)</enum><text>Automated vehicles and unmanned delivery systems.</text></clause><clause id="H790A382A549A4E3AA09F520D2D49582C"><enum>(iii)</enum><text>Blockchain and other distributed ledger, data storage, data management, and cybersecurity technologies.</text></clause><clause id="HA21B9FE6D7DE407E9843CA32BEFC31E2"><enum>(iv)</enum><text>Quantum computing and quantum sensing.</text></clause><clause id="H6334CF200A894D928106D9E36FF2AFBC"><enum>(v)</enum><text>Additive manufacturing.</text></clause><clause id="H8FDB24895551473F9D4D475C564DD8D0"><enum>(vi)</enum><text>Advanced manufacturing and the Internet of Things.</text></clause><clause id="HC83BB2F49570472693E58ABDFEE00E04"><enum>(vii)</enum><text>Nano technology.</text></clause><clause id="HE21E7676CBD845F5BA641606BEB4CC3F"><enum>(viii)</enum><text>Robotics.</text></clause><clause id="H23C9FA46A55F4522B7D7C76DD379BA0D"><enum>(ix)</enum><text>Microelectronics, optical fiber ray, and high performance and advanced computer hardware and software.</text></clause><clause id="H8A215FD5A0024BC59D4BB7163E4EA982"><enum>(x)</enum><text>Semiconductors.</text></clause><clause id="H9C67B26C4F97481F9619C9423DE67C5D"><enum>(xi)</enum><text>Advanced materials science, including composition 2D, other next generation materials, and related manufacturing technologies.</text></clause></subparagraph></paragraph><paragraph id="H3EA0DC2D9CDF455599E5A3477FE928B7"><enum>(13)</enum><header>Institution of higher education</header><text>The term <term>institution of higher education</term> has the meaning given that term in section 101 of the Higher Education Act of 1965 (<external-xref legal-doc="usc" parsable-cite="usc/20/1001">20 U.S.C. 1001</external-xref>).</text></paragraph><paragraph id="H09735F47891E409B8426F76C4EDF4589"><enum>(14)</enum><header>Manufacture</header><text>The term <term>manufacture</term>—</text><subparagraph id="H3DAAB3D8694948C99502FFA124A9240B"><enum>(A)</enum><text>means any activity that is necessary for the development, production, processing, distribution, or delivery of any raw, in process, or manufactured material (including any mineral, metal, and advanced processed material), article, commodity, supply, product, critical good, or item of supply; and</text></subparagraph><subparagraph id="HAAEDDA1EEF134E3CA3AF4CA4AE9B081D"><enum>(B)</enum><text>does not include software unrelated to the manufacturing process.</text></subparagraph></paragraph><paragraph id="H93E777C61AD948F28730A81E367595A6"><enum>(15)</enum><header>Manufacturing technology</header><text>The term <term>manufacturing technology</term> means a technology that is necessary for the manufacturing of a critical good.</text></paragraph><paragraph id="H65A58756E5ED4729AFB3CA61F1CDCC99"><enum>(16)</enum><header>Production equipment</header><text>The term <term>production equipment</term> means any component, subsystem, system, equipment, tooling, accessory, part, or assembly necessary for the manufacturing of a critical good.</text></paragraph><paragraph id="H52574B5DA92043D580E97C15FD278332"><enum>(17)</enum><header>Relevant committees of Congress</header><text>The term <term>relevant committees of Congress</term> means the following:</text><subparagraph id="H93722F67BFF34662A9D31A43E102AF35"><enum>(A)</enum><text>The Committee on Commerce, Science, and Transportation of the Senate.</text></subparagraph><subparagraph id="H15DEC45F70234D90855F12331A4BCE23"><enum>(B)</enum><text>The Committee on Energy and Commerce of the House of Representatives.</text></subparagraph></paragraph><paragraph id="H8F09FFA7554843EA93A5314DB3CB67A7"><enum>(18)</enum><header>Resilient critical supply chain</header><text>The term <term>resilient critical supply chain</term> means a critical supply chain that—</text><subparagraph id="HED6FBCEC3E6145ABA3751A5368EB717C"><enum>(A)</enum><text>ensures that the United States can sustain critical industry, including emerging technologies, production, critical supply chains, services, and access to critical goods, production equipment, and manufacturing technology during a supply chain shock; and</text></subparagraph><subparagraph id="HDE52F4D008CA44D8AA3C72B61C1B98CB"><enum>(B)</enum><text>has key components of resilience that include—</text><clause id="H1B2D117762884E30AA731C28C9A8974D"><enum>(i)</enum><text>effective private sector risk management and mitigation planning to sustain critical supply chains and supplier networks during a supply chain shock; and</text></clause><clause id="H8E76F36362BB464599AC1AA5629A7FD7"><enum>(ii)</enum><text>minimized or managed exposure to a supply chain shock.</text></clause></subparagraph></paragraph><paragraph id="HA083483664CF4E92BF43A60B4AB810BA"><enum>(19)</enum><header>Secretary</header><text>The term <term>Secretary</term> means the Secretary of Commerce.</text></paragraph><paragraph id="H7530F56DF477478A8B8C2D0E3804FD80"><enum>(20)</enum><header>State</header><text>The term <term>State</term> means each of the several States, the District of Columbia, each commonwealth, territory, or possession of the United States, and each federally recognized Indian Tribe.</text></paragraph><paragraph id="H60E3E5C810B44CD58B5B02C8573A0EAE" commented="no"><enum>(21)</enum><header>Supply chain shock</header><text>The term <term>supply chain shock</term>—</text><subparagraph id="H26B4173DB1614E0190EDAC6AA4986A60" commented="no"><enum>(A)</enum><text>means an event causing severe or serious disruption to normal operations or capacity in a supply chain; and</text></subparagraph><subparagraph id="HEAD96275A29D42E39A6147E4226363E3" commented="no"><enum>(B)</enum><text>includes—</text><clause id="HDF4D1FE43AF04727B89C7BC1C5432166" commented="no"><enum>(i)</enum><text>a natural disaster;</text></clause><clause id="HA9724C960C3E4B88852A6A522EBDBB5C" commented="no"><enum>(ii)</enum><text>a pandemic;</text></clause><clause id="H6C23D21292E647E2B5EF436A74AAE06D" commented="no"><enum>(iii)</enum><text>a biological threat;</text></clause><clause id="H42006D328CC2469CAE09EB64F6D07CE6" commented="no"><enum>(iv)</enum><text>a cyber attack;</text></clause><clause id="HF805CBFEE79C47AA8DDB240A6061D5C4" commented="no"><enum>(v)</enum><text>a geopolitical conflict;</text></clause><clause id="H050123901B204C998DB70A7A777DBCBC" commented="no"><enum>(vi)</enum><text>a terrorist or geopolitical attack;</text></clause><clause id="HAB16ADFE62BC441590296216378A7B56" commented="no"><enum>(vii)</enum><text>a trade disruption caused by—</text><subclause id="H004E23C23BB24BC39EE141C41B8196F8" commented="no"><enum>(I)</enum><text>a country described in paragraph (2)(B); or</text></subclause><subclause id="H992313FEA3A143BA88CC9D5296E57FC0" commented="no"><enum>(II)</enum><text>an entity or an individual subject to the jurisdiction of such a country; and</text></subclause></clause><clause id="H2919192A8A33453A87B7D615459A2FF5" commented="no" display-inline="no-display-inline"><enum>(viii)</enum><text>an event for which the President declares a major disaster or an emergency under section 401 or 501, respectively, of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/42/5170">42 U.S.C. 5170</external-xref>; <external-xref legal-doc="usc" parsable-cite="usc/42/5191">42 U.S.C. 5191</external-xref>).</text></clause></subparagraph></paragraph></section></title><title id="HFF68D17D95D44AC69F9F9489193531F8"><enum>V</enum><header>Deploying American Blockchains</header><section id="H71B5949BE8A140AB8408600F55DDA2C7"><enum>501.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Deploying American Blockchains Act</short-title></quote>.</text></section><section id="H108206CBBADE46C5A26E2C2890B4F4CF"><enum>502.</enum><header>Definitions</header><text display-inline="no-display-inline">In this title:</text><paragraph id="HF61783E574AB472F8447A286644AF6F9"><enum>(1)</enum><header>Advisory Committee</header><text>The term <term>Advisory Committee</term> means the National Blockchain Deployment Advisory Committee established pursuant to section 503(c).</text></paragraph><paragraph id="H3A4B3753D17547279C209B128F2E8C6E"><enum>(2)</enum><header>Blockchain technology or other distributed ledger technology</header><text>The term <term>blockchain technology or other distributed ledger technology</term> means a distributed digital database where data is—</text><subparagraph id="H3C8055A1ACE34843A0DC43F8C071AF8F"><enum>(A)</enum><text>shared across a network of computers to create a ledger of verified information among network participants;</text></subparagraph><subparagraph id="H79D469CC045148AA999E8A4D3188CAEF"><enum>(B)</enum><text>linked using cryptography to maintain the integrity of the ledger and to execute other functions; and</text></subparagraph><subparagraph id="H89F06A72795A4F0981A023F7CB0527B4"><enum>(C)</enum><text>distributed among network participants in an automated fashion to concurrently update network participants on the state of the ledger and other functions.</text></subparagraph></paragraph><paragraph id="H4137DA59BE9D4DA6A1387C47E787E017"><enum>(3)</enum><header>Covered nongovernmental representative</header><text display-inline="yes-display-inline">The term <term>covered nongovernmental representative</term> means a representative as specified in the second sentence of section 135(b)(1) of the Trade Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/19/2155">19 U.S.C. 2155(b)(1)</external-xref>), except that such term does not include a representative of a non-Federal government.</text></paragraph><paragraph id="H554427F2EBD7442EA08F990E93C5A810"><enum>(4)</enum><header>Secretary</header><text>The term <term>Secretary</term> means the Secretary of Commerce.</text></paragraph><paragraph id="H77412146E6954FA68F56C1E26BCF4B0C"><enum>(5)</enum><header>State</header><text>The term <term>State</term> means each of the several States, the District of Columbia, each commonwealth, territory, or possession of the United States, and each federally recognized Indian Tribe.</text></paragraph><paragraph id="HFF6F99BA5DFF4DB4AC8225DF0BA2BB1F"><enum>(6)</enum><header>Token</header><text>The term <term>token</term> means a transferable, digital representation of information recorded on blockchain technology or other distributed ledger technology.</text></paragraph><paragraph id="H18B76CFD65474C5783E71976476CAAA0"><enum>(7)</enum><header>Tokenization</header><text>The term <term>tokenization</term> means the process of creating a token.</text></paragraph></section><section id="HED5E4AFDD2624E959744EE74DE1D121C"><enum>503.</enum><header>Department of Commerce leadership on blockchain</header><subsection id="H77DC1F86EDE24A3CA0E848C47ED1EFF1"><enum>(a)</enum><header>Function of Secretary</header><text>The Secretary shall serve as a principal advisor to the President for policy pertaining to the deployment, use, application, and competitiveness of blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization.</text></subsection><subsection id="H052DD3307A614300848693463FACE861"><enum>(b)</enum><header>Activities</header><text>The Secretary shall support the leadership of the United States with respect to the deployment, use, application, and competitiveness of blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization by organizing the Advisory Committee—</text><paragraph id="H6F4E196D170847BEBF469EC54C74FDA4"><enum>(1)</enum><text>to examine and to provide recommendations on issues and risks relating to the deployment, use, application, and competitiveness of blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization, including the issues of decentralized identity, cybersecurity, key storage and security systems, artificial intelligence, fraud reduction, regulatory compliance, e-commerce, health care applications, and supply chain resiliency;</text></paragraph><paragraph id="HE264CBAEFC6041C49FA22EABB1BDB57E"><enum>(2)</enum><text>to support and to promote the improvement and security of blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization;</text></paragraph><paragraph id="H06A8316624F84CBC8702E8A00CD73848"><enum>(3)</enum><text>to help to promote the leadership of the United States with respect to the deployment, use, application, and competitiveness of blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization;</text></paragraph><paragraph id="H6CD61F7DE3EA488F89184C248CDB9A8F"><enum>(4)</enum><text>to promote the national security of the United States with respect to blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization;</text></paragraph><paragraph id="H5EF958FDB9DE4A2F873A619D68032FD4"><enum>(5)</enum><text>to support engagement with the public to develop a compendium of proposals for practices as part of the work described in subsection (d);</text></paragraph><paragraph id="H4135D3B3342F4D1298BBD3D569F971DF"><enum>(6)</enum><text>to consider policies to encourage coordination among Federal agencies with respect to the deployment of blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization;</text></paragraph><paragraph id="H1C2C72F6705C4A49833BAA8F3C210934"><enum>(7)</enum><text>to examine—</text><subparagraph id="H1BB69ED4E1EE458BB87C4D6724A8E4D8"><enum>(A)</enum><text>how Federal agencies can benefit from utilizing blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization;</text></subparagraph><subparagraph id="HA9381A3C3BF441D29B6311E497964F36"><enum>(B)</enum><text>the current use by Federal agencies of blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization;</text></subparagraph><subparagraph id="HFCDEBF41AC20483A80442DE31368CD19"><enum>(C)</enum><text>the current and future preparedness and ability of Federal agencies to adopt blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization; and</text></subparagraph><subparagraph id="H53D3459DFCFE44D48AB559BEF497F5BE"><enum>(D)</enum><text>additional security measures Federal agencies may need to take—</text><clause id="H0AA6A153D25F416196EFBC0974ADCBF4"><enum>(i)</enum><text>to securely use blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization, including to support the security of critical infrastructure; and</text></clause><clause id="HFEE27DDB723C42F1A3EEF576DB3BFEFE"><enum>(ii)</enum><text>to enhance the resiliency of Federal systems against cyber threats to blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization; and</text></clause></subparagraph></paragraph><paragraph id="HF906E48B7645435289CD4B97DDF0DEF6"><enum>(8)</enum><text>to support coordination of the activities of the Federal Government relating to the security of blockchain technology and other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization.</text></paragraph></subsection><subsection id="H91B6B7A1FD4F4D61B9529E272E356BE4"><enum>(c)</enum><header>Establishment of National Blockchain Deployment Advisory Committee</header><paragraph id="HA8113EFC7367473E97EE3346C5CFAC97"><enum>(1)</enum><header>Establishment</header><subparagraph commented="no" display-inline="no-display-inline" id="HCF5752E18E2743CBBA04B632014F27D4"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 180 days after the date of the enactment of this Act, the Secretary shall, in consultation with the heads of relevant Federal agencies, establish an advisory committee to support the adoption of blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4D9778737EAD4F7A85F0960E48AC19DB"><enum>(B)</enum><header>Designation</header><text>The advisory committee established pursuant to subparagraph (A) shall be known as the <quote>National Blockchain Deployment Advisory Committee</quote>.</text></subparagraph></paragraph><paragraph id="H729FAF2613AD421F9C3A1E80F28BC852"><enum>(2)</enum><header>Membership composition</header><text>The Advisory Committee shall consist of members appointed by the Secretary, which shall include—</text><subparagraph id="HEDA5C3AE743E410D8BA7AF99A8C77857"><enum>(A)</enum><text>the Secretary;</text></subparagraph><subparagraph id="HFABB507A28D44D039881A9007D4C8E2F"><enum>(B)</enum><text>representatives of Federal agencies (as determined necessary by the Secretary); and</text></subparagraph><subparagraph id="HBC7E1F08D1FF476BBDE3774B6114C5DA"><enum>(C)</enum><text display-inline="yes-display-inline">covered nongovernmental representatives with expertise related to blockchain technology or other distributed ledger technology (as determined necessary by the Secretary), which may include—</text><clause id="HC302F83CD8824A55A8C403B9F7AF7583"><enum>(i)</enum><text>blockchain technology or other distributed ledger technology infrastructure operators, suppliers, service providers, and vendors;</text></clause><clause id="H4E186DFDEAB74EE9AF5F35ECD5C9BA00"><enum>(ii)</enum><text>application developers building on blockchain technology or other distributed ledger technology;</text></clause><clause id="HA25FA2A1FA524B7E850827020290B74F"><enum>(iii)</enum><text>developers and organizations supporting the advancement and deployment of public blockchain technology or other distributed ledger technology;</text></clause><clause id="HE11C71DE77F040518B87B6C0F3F4E1EF"><enum>(iv)</enum><text>subject matter experts representing industrial sectors that can benefit from blockchain technology or other distributed ledger technology;</text></clause><clause id="HAEC4F8BAB9544A0D98923939005F61B3"><enum>(v)</enum><text>small, medium, and large businesses;</text></clause><clause id="H0BE6596AEAFE4A96BC227F53631B9048"><enum>(vi)</enum><text>think tanks and academia;</text></clause><clause id="H2C777EA3BCE244B19F6100BC5775D36E"><enum>(vii)</enum><text>nonprofit organizations and consumer groups;</text></clause><clause id="H6B1D1C873F05490ABCC1652DCB2262D0"><enum>(viii)</enum><text>cybersecurity experts;</text></clause><clause id="H833962CD6E0940F78CDE019F36FEC540"><enum>(ix)</enum><text>rural stakeholders;</text></clause><clause id="H022EE80A079C459381920200A3D5C003"><enum>(x)</enum><text>covered nongovernmental representatives; and</text></clause><clause id="H83E202604EBA421F9CCBE74EA2B1EC05"><enum>(xi)</enum><text>artists and the content creator community.</text></clause></subparagraph></paragraph><paragraph id="H5AF5423697F84085A51F1676DC9B11CE"><enum>(3)</enum><header>Termination of Advisory Committee</header><text>The Advisory Committee shall terminate on the date that is 7 years after the date of the enactment of this Act. </text></paragraph></subsection><subsection id="H955C492B094E4F33B13DF07BEC11E103"><enum>(d)</enum><header>Best practices</header><text>The Secretary shall, on an ongoing basis, facilitate and support the development of a compendium of identified or recommended guidelines or best practices for the deployment of blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization that—</text><paragraph id="H45353E905FB54F42A1588DF070B5165A"><enum>(1)</enum><text>support the deployment of technologies needed to advance the capabilities of blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization;</text></paragraph><paragraph id="H357F093F5FC64BDFA8C4DFE66D29D6B7"><enum>(2)</enum><text>support the interoperability of blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization;</text></paragraph><paragraph id="HBEA946683F4E44C78F952C6D6D3A5127"><enum>(3)</enum><text>support operations, including hashing and key storage and security systems, that form the foundation of blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization;</text></paragraph><paragraph id="H43F9C6AFCA204CBDB6FFBB93B4294D67"><enum>(4)</enum><text>reduce cybersecurity risks that may compromise blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization; and</text></paragraph><paragraph id="H4E4AD88ED6974095B83CA2484D17DE7C"><enum>(5)</enum><text>quantify the value and potential cost savings associated with adoption of blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization, including through comparative analyses of competing and existing technologies within specific industry applications.</text></paragraph></subsection><subsection id="H04505AD202144B2ABB6F952FE28F2E9A"><enum>(e)</enum><header>Additional requirements</header><text>In carrying out this section, the Secretary shall—</text><paragraph id="H314F02C1D97B4C559C4A5BF527A65178"><enum>(1)</enum><text>consult closely and regularly with stakeholders, including private sector individuals and entities, and incorporate industry expertise;</text></paragraph><paragraph id="H73806B6DC40F40F28EEF2E549FCBAAF4"><enum>(2)</enum><text>collaborate with private sector stakeholders to identify prioritized, flexible, repeatable, performance-based, and cost-effective approaches to the deployment of blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization;</text></paragraph><paragraph id="HD6FD1801AAF2491CB2A8A2EBB87DA8DA"><enum>(3)</enum><text>make public research and information pertaining to the use of, and marketplace for, blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization;</text></paragraph><paragraph id="H05F53420E94040DCBC9A5BFC6A360256"><enum>(4)</enum><text>develop standardized terminology for, and promote common understanding of, blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization;</text></paragraph><paragraph id="HE2E58677698042A0AE6A7B995829E700"><enum>(5)</enum><text>align the recommendations of the compendium described in subsection (d) with the goal of facilitating the ease of use of blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization;</text></paragraph><paragraph id="HBA7DE082FF5548C88B6E9F31ABF07416"><enum>(6)</enum><text>support open-source infrastructure, data management, and authentication activities with respect to blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization; and</text></paragraph><paragraph id="HA79AB11D07364931B9E32F0BD607FDA1"><enum>(7)</enum><text>consider the needs and interests of both the private and public sector, including small businesses and Federal, State, and local governments.</text></paragraph></subsection><subsection id="HE6F5413B5FCD4B75B61AF3B7DA88A5EC"><enum>(f)</enum><header>Rules of construction</header><text>Nothing in this section may be construed—</text><paragraph id="HC638CFC30B2E42F0BB82D1B7A5AA36E2"><enum>(1)</enum><text>to require a private entity to share information with the Secretary;</text></paragraph><paragraph id="H7F53C131DD944E88A19CA822427E4E4D"><enum>(2)</enum><text>to require a private entity to request assistance from the Secretary;</text></paragraph><paragraph id="H3F5C9D47960643CC841FEE8AB1686112"><enum>(3)</enum><text>to require a private entity to implement any measure or recommendation suggested by the Secretary in response to a request by the private entity; or</text></paragraph><paragraph id="HBB4EE0DC03A5470991A661E94495414D"><enum>(4)</enum><text>to require the adoption of the best practices described in subsection (d).</text></paragraph></subsection><subsection id="HCBA33E293AE84225960676213179C299"><enum>(g)</enum><header>Consultation</header><text>In implementing this section, the Secretary may, as appropriate, consult with the heads of relevant Federal agencies.</text></subsection></section><section id="H4C6EA9DF1069431A9A64EF3124B36613"><enum>504.</enum><header>Reports to Congress</header><subsection id="H1D1277C688054721B6A04B9CD458C0DC"><enum>(a)</enum><header>Interim reports</header><text>Not later than 2 years after the date of the enactment of this Act, and annually thereafter, the Secretary shall make public on the website of the Department of Commerce and submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes—</text><paragraph id="H977F70470EC24346BCDB98158D28AC64"><enum>(1)</enum><text>a description of the activities of the Secretary under this title during the preceding year;</text></paragraph><paragraph id="H1D4177B31EAF449C832C1DC1F4128452"><enum>(2)</enum><text>any recommendations by the Secretary for additional legislation to strengthen the competitiveness of the United States with respect to blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization; and</text></paragraph><paragraph id="H299C6432645A44A0B75C316F15312AE7"><enum>(3)</enum><text>a description of any emerging risks and long-term trends with respect to blockchain technology or other distributed ledger technology, applications built on blockchain technology or other distributed ledger technology, tokens, and tokenization.</text></paragraph></subsection><subsection id="HE8C171C47F2A42B0BC1AB845A488C2F8" commented="no" display-inline="no-display-inline"><enum>(b)</enum><header>Final report</header><text display-inline="yes-display-inline">Not later than 18 months before the termination of the Advisory Committee pursuant to section 503(c)(3), the Secretary shall make available to the public on the website of the Department of Commerce and submit to the President, the Committee on Commerce, Science, and Transportation of the Senate, and the Committee on Energy and Commerce of the House of Representatives a final report containing the findings, conclusions, and recommendations of the Advisory Committee.</text></subsection></section></title><title id="HB609334B398148CD8F76A800C9B3C249" style="OLC" commented="no"><enum>VI</enum><header>FUTURE Networks Act</header><section id="HCA531835571D40F884B2D13778CC9E37" commented="no"><enum>601.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Future Uses of Technology Upholding Reliable and Enhanced Networks Act</quote> or the <quote>FUTURE Networks Act</quote>.</text></section><section id="H089F51F11A7D484088E98EBC7D31C31E" commented="no"><enum>602.</enum><header>6G task force</header><subsection id="HC8FA66BB6BB84B02B5BDA0B8A186FA81" commented="no"><enum>(a)</enum><header>Establishment</header><text>Not later than 120 days after the date of the enactment of this Act, the Commission shall establish a task force to be known as the <quote>6G Task Force</quote>.</text></subsection><subsection id="H60FCAEBB4AD4456E8EC40671F9F4D6AC" commented="no"><enum>(b)</enum><header>Membership</header><paragraph id="HE0FE2E8B1566413DA2AB6ED34B2907F1" commented="no"><enum>(1)</enum><header>Appointment</header><text>The members of the Task Force shall be appointed by the Chair.</text></paragraph><paragraph id="HC55B61EE1ABE4BEE9086D6EBC3BEA945" commented="no"><enum>(2)</enum><header>Composition</header><text>To the extent practicable, the membership of the Task Force shall be composed of the following:</text><subparagraph id="H9ADCE735D6884940A8EE1777AD72A005" commented="no"><enum>(A)</enum><text>Representatives of companies in the communications industry, except companies that are determined by the Chair to be not trusted.</text></subparagraph><subparagraph id="HD7C1B54388CF4ADF83A59D3B186E3300" commented="no"><enum>(B)</enum><text>Representatives of public interest organizations or academic institutions, except public interest organizations or academic institutions that are determined by the Chair to be not trusted.</text></subparagraph><subparagraph id="H5424AE229CD94D7C9B447B7424679659" commented="no"><enum>(C)</enum><text>Representatives of the Federal Government, State governments, local governments, or Tribal Governments, with at least one member representing each such type of government.</text></subparagraph></paragraph></subsection><subsection id="H67E6870F4C2443AE893B52D7AB2C7159" commented="no"><enum>(c)</enum><header>Report</header><paragraph id="H2429EB8447AD4115B91B7854F9372440" commented="no"><enum>(1)</enum><header>In general</header><text>Not later than 1 year after the date on which the Task Force is established under subsection (a), the Task Force shall publish in the Federal Register and on the website of the Commission, and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Commerce, Science, and Transportation of the Senate, a report on sixth-generation wireless technology, including—</text><subparagraph id="H3E1EC6F037B742C083D4E2A814F96A52" commented="no"><enum>(A)</enum><text>the status of industry-led standards-setting bodies in setting standards for such technology;</text></subparagraph><subparagraph id="HA369E38934E34AA8981F88057A9F845D" commented="no"><enum>(B)</enum><text>possible uses of such technology identified by industry-led standards-setting bodies that are setting standards for such technology;</text></subparagraph><subparagraph id="H509364931D304F9F9BCD904D38872E0E" commented="no"><enum>(C)</enum><text>any limitations of such technology (including any supply chain or cybersecurity limitations) identified by industry-led standards-setting bodies that are setting standards for such technology;</text></subparagraph><subparagraph id="H7748ED00EC75424580263442250C99CB" commented="no"><enum>(D)</enum><text>workforce needs to build, maintain, and utilize 6G and advanced wireless communications technologies and networks, and strategies to conduct the necessary workforce training;</text></subparagraph><subparagraph id="H4A296541F1E84115818C24319E85D7C1" commented="no"><enum>(E)</enum><text>possible uses of emerging technologies and Open RAN networks to bolster 6G and advanced wireless networks; and</text></subparagraph><subparagraph id="H64A249D2543D4A10B764CDF887F20ACF" commented="no"><enum>(F)</enum><text>how to best work with entities across the Federal Government, State governments, local governments, and Tribal Governments to leverage such technology, including with regard to siting, deployment, and adoption.</text></subparagraph></paragraph><paragraph id="H805E65066E154803A7E2B294D565861E" commented="no"><enum>(2)</enum><header>Draft report; public comment</header><text>The Task Force shall—</text><subparagraph id="HD8A5B5E990A54DB984B4B98A17369494" commented="no"><enum>(A)</enum><text>not later than 180 days after the date on which the Task Force is established under subsection (a), publish in the Federal Register and on the website of the Commission a draft of the report required by paragraph (1); and</text></subparagraph><subparagraph id="H8FF8F7562146460285E8DEAD47FB0435" commented="no"><enum>(B)</enum><text>accept public comments on such draft and take such comments into consideration in preparing the final version of such report.</text></subparagraph></paragraph></subsection><subsection id="H268DE516D3634480939B387BE94D13BD" commented="no"><enum>(d)</enum><header>Definitions</header><text>In this section:</text><paragraph id="H0A7D16B9CE3A4307B8E47C4401431C27" commented="no"><enum>(1)</enum><header>Chair</header><text>The term <term>Chair</term> means the Chair of the Commission.</text></paragraph><paragraph id="HB86B7B40281C4565979543CFF37C7696" commented="no"><enum>(2)</enum><header>Commission</header><text>The term <term>Commission</term> means the Federal Communications Commission.</text></paragraph><paragraph id="H7675E0BC3C544DDD86E3AEBF4172413B" commented="no"><enum>(3)</enum><header>Not trusted</header><subparagraph id="H8A3E710C2C81438B8367F32B3CF78A2C" commented="no"><enum>(A)</enum><header>In general</header><text>The term <term>not trusted</term> means, with respect to an entity, that—</text><clause id="HCCE174EC61DC460299773F58A449CBE8" commented="no"><enum>(i)</enum><text>the Chair has made a public determination that such entity is owned by, controlled by, or subject to the influence of a foreign adversary; or</text></clause><clause id="H571A9F6B8D0046B18525B18B166832DA" commented="no"><enum>(ii)</enum><text>the Chair otherwise determines that such entity poses a threat to the national security of the United States.</text></clause></subparagraph><subparagraph id="H84286D1405124D00BEC6C42E0398763F" commented="no"><enum>(B)</enum><header>Criteria for determination</header><text>In making a determination under subparagraph (A)(ii), the Chair shall use the criteria described in paragraphs (1) through (4) of section 2(c) of the Secure and Trusted Communications Networks Act of 2019 (<external-xref legal-doc="usc" parsable-cite="usc/47/1601">47 U.S.C. 1601(c)</external-xref>), as appropriate.</text></subparagraph></paragraph><paragraph id="HC0389E57B8E445279F7A68F57AD77499" commented="no"><enum>(4)</enum><header>State</header><text>The term <term>State</term> has the meaning given such term in section 3 of the Communications Act of 1934 (<external-xref legal-doc="usc" parsable-cite="usc/47/153">47 U.S.C. 153</external-xref>).</text></paragraph><paragraph id="HDDA98BBC8523425B8898B141AE9DFEDA" commented="no"><enum>(5)</enum><header>Task force</header><text>The term <term>Task Force</term> means the 6G Task Force established under subsection (a).</text></paragraph></subsection></section><section id="H5A9FCB82F5094D7288D06A2B1558B6F3" commented="no"><enum>603.</enum><header>Termination of Task Force</header><text display-inline="no-display-inline">The Task Force shall be terminated 30 days after the date on which the Task Force submits the report required under section 602(c).</text></section></title><title id="HD07EB4836B9D42528736A46214BC3953" style="OLC" commented="no"><enum>VII</enum><header>Secure Space Act</header><section id="HFE4EDB6891D045E381293648AA970C5E" changed="not-changed" commented="no"><enum>701.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Secure Space Act</quote>.</text></section><section id="H4D2B6627BFD34A2D8832BF96CF7C3B09" changed="not-changed" commented="no"><enum>702.</enum><header>Prohibition on grant of certain satellite licenses, United States market access, or earth station authorizations</header><subsection id="H1D2FBF2054E7479EBF7C66F7F5B2A703" changed="not-changed" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secure and Trusted Communications Networks Act of 2019 (<external-xref legal-doc="usc" parsable-cite="usc/47/1601">47 U.S.C. 1601 et seq.</external-xref>) is amended—</text><paragraph id="H4BDFDF4B8E8242FCB8DE2FDCFA5B4316" changed="not-changed" commented="no"><enum>(1)</enum><text>by redesignating sections 10 and 11 as sections 11 and 12, respectively; and</text></paragraph><paragraph id="H0419C63795BB42939BD3F4EB5136ED07" changed="not-changed" commented="no"><enum>(2)</enum><text>by inserting after section 9 the following:</text><quoted-block style="OLC" id="HFE1A236F69C9481DACF41927A9BCC868" display-inline="no-display-inline" changed="not-changed"><section id="H46743B27B8714C39B91B0FC7D9C27A1B" changed="not-changed" commented="no"><enum>10.</enum><header>Prohibition on grant of certain satellite licenses, United States market access, or earth station authorizations</header><subsection id="H77D6223759D8476EB34A48B6B26FF4CC" changed="not-changed" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Commission may not grant a license for, or a petition for a declaratory ruling to access the United States market using, a geostationary orbit satellite system or a nongeostationary orbit satellite system, or an authorization to use an individually licensed earth station or a blanket-licensed earth station, if such license, grant of market access, or authorization would be held or controlled by—</text><paragraph id="H1872873D4EEC49B886357129B4487022" changed="not-changed" commented="no"><enum>(1)</enum><text>an entity that produces or provides any covered communications equipment or service; or</text></paragraph><paragraph id="H5CD0532F43BC4C80B0E3F2996EE702E4" changed="not-changed" commented="no"><enum>(2)</enum><text display-inline="yes-display-inline">an affiliate (as defined in section 3 of the Communications Act of 1934 (<external-xref legal-doc="usc" parsable-cite="usc/47/153">47 U.S.C. 153</external-xref>)) of an entity described in paragraph (1).</text></paragraph></subsection><subsection id="HB95B9A0BA72944E883B85949D565296F" changed="not-changed" commented="no"><enum>(b)</enum><header>Definitions</header><text>In this section:</text><paragraph id="HD7BE025915714CE98CF8BEEB2AC68B28" changed="not-changed" commented="no"><enum>(1)</enum><header>Blanket-licensed earth station</header><text>The term <term>blanket-licensed earth station</term> means an earth station that is licensed with a geostationary orbit satellite system or a nongeostationary orbit satellite system.</text></paragraph><paragraph id="HFF3FE7C958884E29AF9169ADF7D4C263" changed="not-changed" commented="no"><enum>(2)</enum><header>Gateway station</header><text display-inline="yes-display-inline">The term <term>gateway station</term> means an earth station or a group of earth stations that—</text><subparagraph id="H4D9E9F8DB5CF48708F356FC4846CE479" changed="not-changed" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">supports the routing and switching functions of a geostationary orbit satellite system or a nongeostationary orbit satellite system;</text></subparagraph><subparagraph id="H82EFA62718B0405087AF1558A3BA9D66" changed="not-changed" commented="no"><enum>(B)</enum><text>may also be used for telemetry, tracking, and command transmissions;</text></subparagraph><subparagraph id="HBA7BDC300EE74964A018C1C95C896ABE" changed="not-changed" commented="no"><enum>(C)</enum><text>does not originate or terminate communication traffic; and</text></subparagraph><subparagraph id="HBFF0418776BC4C26A7ED17824B32336D" changed="not-changed" commented="no"><enum>(D)</enum><text>is not for the exclusive use of any customer.</text></subparagraph></paragraph><paragraph id="HD8D1A884178F44309EE9B33304A954C0" changed="not-changed" commented="no"><enum>(3)</enum><header>Individually licensed earth station</header><text display-inline="yes-display-inline">The term <term>individually licensed earth station</term> means—</text><subparagraph id="H8A8328D8AA0B4479AE90553F46341E1F" changed="not-changed" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">an earth station (other than a blanket-licensed earth station) that sends a signal to, and receives a signal from, a geostationary orbit satellite system or a nongeostationary orbit satellite system; or</text></subparagraph><subparagraph id="HEB9FBE9FF3704573BED125837F27CBAD" changed="not-changed" commented="no"><enum>(B)</enum><text>a gateway station.</text></subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HC06AF3900A26498FA5448637746FBA9B" changed="not-changed" commented="no"><enum>(b)</enum><header>Applicability</header><text display-inline="yes-display-inline">Section 10 of the Secure and Trusted Communications Networks Act of 2019, as added by subsection (a), shall apply with respect to the grant of a license, petition, or authorization on or after the date of the enactment of this Act.</text></subsection><subsection id="HC9169D75E57D4FDCAA1B6CFA046B7BFD" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(c)</enum><header>Rules</header><text display-inline="yes-display-inline">Not later than 1 year after the date of the enactment of this Act, the Federal Communications Commission shall issue rules to implement section 10 of the Secure and Trusted Communications Networks Act of 2019, as added by subsection (a).</text></subsection></section></title><title id="H5340C2548E604083846E73BB707A556F" style="OLC" commented="no"><enum>VIII</enum><header>TAKE IT DOWN Act</header><section id="HD06247D2DF0B440EB89B681085D30312" commented="no" display-inline="no-display-inline"><enum>801.</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Tools to Address Known Exploitation by Immobilizing Technological Deepfakes on Websites and Networks Act</quote> or the <quote>TAKE IT DOWN Act</quote>.</text></section><section id="H2EC69160F1074AD5B68B2CDCEA34BFE4" commented="no" display-inline="no-display-inline" section-type="subsequent-section"><enum>802.</enum><header display-inline="yes-display-inline">Criminal prohibition on intentional disclosure of nonconsensual intimate visual depictions</header><subsection commented="no" display-inline="no-display-inline" id="H38C0FFA5E000452291A00B1BE9F61984"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 223 of the Communications Act of 1934 (<external-xref legal-doc="usc" parsable-cite="usc/47/223">47 U.S.C. 223</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H1F674175F67947358953984424727749"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating subsection (h) as subsection (i); and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD347C3B5B089465B8E1C9C3977DEFB83"><enum>(2)</enum><text display-inline="yes-display-inline">by inserting after subsection (g) the following:</text><quoted-block style="USC" display-inline="no-display-inline" id="HDECE9D38754E4C6CA488029BDD31A073"><subsection commented="no" display-inline="no-display-inline" id="H30ACB2E2C4CD4A558BB79D6D27CA0FDB"><enum>(h)</enum><header display-inline="yes-display-inline">Intentional disclosure of nonconsensual intimate visual depictions</header><paragraph commented="no" display-inline="no-display-inline" id="H870D50231EB54033931F2C24D48CFA3C"><enum>(1)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this subsection:</text><subparagraph commented="no" display-inline="no-display-inline" id="H34FBEEC5860942C4969756DDEF9F94FB"><enum>(A)</enum><header display-inline="yes-display-inline">Consent</header><text display-inline="yes-display-inline">The term <term>consent</term> means an affirmative, conscious, and voluntary authorization made by an individual free from force, fraud, duress, misrepresentation, or coercion.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HFA2B74F190244D978DDDCB149203E0C8"><enum>(B)</enum><header display-inline="yes-display-inline">Digital forgery</header><text display-inline="yes-display-inline">The term <term>digital forgery</term> means any intimate visual depiction of an identifiable individual created through the use of software, machine learning, artificial intelligence, or any other computer-generated or technological means, including by adapting, modifying, manipulating, or altering an authentic visual depiction, that, when viewed as a whole by a reasonable person, is indistinguishable from an authentic visual depiction of the individual.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2B9607D966AE4FF185C439EE42E23D67"><enum>(C)</enum><header display-inline="yes-display-inline">Identifiable individual</header><text display-inline="yes-display-inline">The term <term>identifiable individual</term> means an individual—</text><clause commented="no" display-inline="no-display-inline" id="H3BF331E1E95C4F828A14F48A2BE47B5A"><enum>(i)</enum><text display-inline="yes-display-inline">who appears in whole or in part in an intimate visual depiction; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H388C40B9E3484CBDA995209F4896C57D"><enum>(ii)</enum><text display-inline="yes-display-inline">whose face, likeness, or other distinguishing characteristic (including a unique birthmark or other recognizable feature) is displayed in connection with such intimate visual depiction.</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HFDB2AC36707D4D579E11C725392289CE"><enum>(D)</enum><header display-inline="yes-display-inline">Interactive computer service</header><text display-inline="yes-display-inline">The term <term>interactive computer service</term> has the meaning given the term in section 230.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC27905E22F7C4ACD86A9D9EF6C966257"><enum>(E)</enum><header display-inline="yes-display-inline">Intimate visual depiction</header><text display-inline="yes-display-inline">The term <term>intimate visual depiction</term> has the meaning given such term in section 1309 of the Consolidated Appropriations Act, 2022 (<external-xref legal-doc="usc" parsable-cite="usc/15/6851">15 U.S.C. 6851</external-xref>).</text></subparagraph><subparagraph id="H234677FCD3234695A93F1E998A0D747E" commented="no" display-inline="no-display-inline"><enum>(F)</enum><header display-inline="yes-display-inline">Minor</header><text display-inline="yes-display-inline">The term <term>minor</term> means any individual under the age of 18 years. </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HCD080F29CBA84B429E88BB017C8BCE57"><enum>(2)</enum><header display-inline="yes-display-inline">Offense involving authentic intimate visual depictions</header><subparagraph id="HC90ECEA2FCAD4B9991744255152152DA" commented="no" display-inline="no-display-inline"><enum>(A)</enum><header display-inline="yes-display-inline">Involving adults</header><text display-inline="yes-display-inline">Except as provided in subparagraph (C), it shall be unlawful for any person, in interstate or foreign commerce, to use an interactive computer service to knowingly publish an intimate visual depiction of an identifiable individual who is not a minor if—</text><clause id="H6ECFEB346DD1474B8DC74682A8BB0715" commented="no" display-inline="no-display-inline"><enum>(i)</enum><text display-inline="yes-display-inline">the intimate visual depiction was obtained or created under circumstances in which the person knew or reasonably should have known the identifiable individual had a reasonable expectation of privacy;</text></clause><clause id="HA9DA272ACB424148AC1485D47623C6F5" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text display-inline="yes-display-inline">what is depicted was not voluntarily exposed by the identifiable individual in a public or commercial setting;</text></clause><clause id="H78C3682B216F45569C0D5572E11893CB" commented="no" display-inline="no-display-inline"><enum>(iii)</enum><text display-inline="yes-display-inline">what is depicted is not a matter of public concern; and</text></clause><clause id="HBFCEEACF07C647D0AAD638057DB1A333" commented="no" display-inline="no-display-inline"><enum>(iv)</enum><text display-inline="yes-display-inline">publication of the intimate visual depiction—</text><subclause id="H6818B92965CF44A0B69EEB263FF139DE" commented="no" display-inline="no-display-inline"><enum>(I)</enum><text display-inline="yes-display-inline">is intended to cause harm; or</text></subclause><subclause id="HFEF0E29BEB86478C8A09305E4A8CBE51" commented="no" display-inline="no-display-inline"><enum>(II)</enum><text display-inline="yes-display-inline">causes harm, including psychological, financial, or reputational harm, to the identifiable individual.</text></subclause></clause></subparagraph><subparagraph id="H42B6D24E673643C48253113B6946BD0E" commented="no" display-inline="no-display-inline"><enum>(B)</enum><header display-inline="yes-display-inline">Involving minors</header><text display-inline="yes-display-inline">Except as provided in subparagraph (C), it shall be unlawful for any person, in interstate or foreign commerce, to use an interactive computer service to knowingly publish an intimate visual depiction of an identifiable individual who is a minor with intent to—</text><clause id="H243E2C49BC87478DAEADBA0E5FD218AA" commented="no" display-inline="no-display-inline"><enum>(i)</enum><text display-inline="yes-display-inline">abuse, humiliate, harass, or degrade the minor; or</text></clause><clause id="H2C0C4B6560894022BF034314336589DA" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text display-inline="yes-display-inline">arouse or gratify the sexual desire of any person.</text></clause></subparagraph><subparagraph id="H69AA5CF1E329404BB9DDBA422B6E3CA3" commented="no" display-inline="no-display-inline"><enum>(C)</enum><header display-inline="yes-display-inline">Exceptions</header><text display-inline="yes-display-inline">Subparagraphs (A) and (B) shall not apply to—</text><clause id="H18631BE4C74241A6B385E3719B323DEB" commented="no" display-inline="no-display-inline"><enum>(i)</enum><text display-inline="yes-display-inline">a lawfully authorized investigative, protective, or intelligence activity of—</text><subclause id="HFE30A5DB8C64407FAC5F56C2392900E7" commented="no" display-inline="no-display-inline"><enum>(I)</enum><text display-inline="yes-display-inline">a law enforcement agency of the United States, a State, or a political subdivision of a State; or</text></subclause><subclause id="H85E0C8986D9740BFB87F97A44512736A" commented="no" display-inline="no-display-inline"><enum>(II)</enum><text display-inline="yes-display-inline">an intelligence agency of the United States;</text></subclause></clause><clause id="HFA6D727B0F1044BDAD5F1AB7A18F12A3" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text display-inline="yes-display-inline">a disclosure made reasonably and in good faith—</text><subclause commented="no" display-inline="no-display-inline" id="H83112B3241894D5E829443984AD47B68"><enum>(I)</enum><text display-inline="yes-display-inline">to a law enforcement officer or agency;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H65D4C1CF91714414BB8F577EA6078B37"><enum>(II)</enum><text display-inline="yes-display-inline">as part of a document production or filing associated with a legal proceeding;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HB6B2295C99FE4144A429484C324CCADB"><enum>(III)</enum><text display-inline="yes-display-inline">as part of medical education, diagnosis, or treatment or for a legitimate medical, scientific, or education purpose;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H1CFA5739D1E841E0BDEAB62629BB5B1A"><enum>(IV)</enum><text display-inline="yes-display-inline">in the reporting of unlawful content or unsolicited or unwelcome conduct or in pursuance of a legal, professional, or other lawful obligation; or</text></subclause><subclause id="HD56AE5A34B06405388E3B8AC848C7606" commented="no" display-inline="no-display-inline"><enum>(V)</enum><text display-inline="yes-display-inline">to seek support or help with respect to the receipt of an unsolicited intimate visual depiction; </text></subclause></clause><clause id="H2E3AD357AEF8419F850CE1FE5F6BCBB0" commented="no" display-inline="no-display-inline"><enum>(iii)</enum><text display-inline="yes-display-inline">a disclosure reasonably intended to assist the identifiable individual; or</text></clause><clause id="H16B8FCC434344F61A0479A609C06D14E" commented="no" display-inline="no-display-inline"><enum>(iv)</enum><text display-inline="yes-display-inline">a person who possesses or publishes an intimate visual depiction of himself or herself engaged in nudity or sexually explicit conduct (as that term is defined in section 2256(2)(A) of title 18, United States Code).</text></clause></subparagraph></paragraph><paragraph id="H3A2EA23803D74140A8345E41BDC3445A" commented="no" display-inline="no-display-inline"><enum>(3)</enum><header display-inline="yes-display-inline">Offense involving digital forgeries</header><subparagraph id="H4E5A706D886B4B9A9654E2485B54CCFB" commented="no" display-inline="no-display-inline"><enum>(A)</enum><header display-inline="yes-display-inline">Involving adults</header><text display-inline="yes-display-inline">Except as provided in subparagraph (C), it shall be unlawful for any person, in interstate or foreign commerce, to use an interactive computer service to knowingly publish a digital forgery of an identifiable individual who is not a minor if—</text><clause id="H0AC8C2115F404CD3ABE4A5B344BF54C1" commented="no" display-inline="no-display-inline"><enum>(i)</enum><text display-inline="yes-display-inline">the digital forgery was published without the consent of the identifiable individual;</text></clause><clause id="HDDA653554AB843A38315E0B6D27BD1AA" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text display-inline="yes-display-inline">what is depicted was not voluntarily exposed by the identifiable individual in a public or commercial setting;</text></clause><clause id="H98C9F6D9694F44548553360831880057" commented="no" display-inline="no-display-inline"><enum>(iii)</enum><text display-inline="yes-display-inline">what is depicted is not a matter of public concern; and</text></clause><clause id="H2DFCDCF5D731429B8815F0A4D66C503B" commented="no" display-inline="no-display-inline"><enum>(iv)</enum><text display-inline="yes-display-inline">publication of the digital forgery—</text><subclause id="HD565CE348ED740C18ED2A8F4100868B9" commented="no" display-inline="no-display-inline"><enum>(I)</enum><text display-inline="yes-display-inline">is intended to cause harm; or</text></subclause><subclause id="HE92A6F0E3F28421AA2A5E979FC11052E" commented="no" display-inline="no-display-inline"><enum>(II)</enum><text display-inline="yes-display-inline">causes harm, including psychological, financial, or reputational harm, to the identifiable individual.</text></subclause></clause></subparagraph><subparagraph id="H219ABD47FE2A4FC5B81CD332E1F555E1" commented="no" display-inline="no-display-inline"><enum>(B)</enum><header display-inline="yes-display-inline">Involving minors</header><text display-inline="yes-display-inline">Except as provided in subparagraph (C), it shall be unlawful for any person, in interstate or foreign commerce, to use an interactive computer service to knowingly publish a digital forgery of an identifiable individual who is a minor with intent to—</text><clause id="HAA879425157D43DB89DACAF1839CD066" commented="no" display-inline="no-display-inline"><enum>(i)</enum><text display-inline="yes-display-inline">abuse, humiliate, harass, or degrade the minor; or</text></clause><clause id="HF3BC04F355A1495D82AF47749C81300D" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text display-inline="yes-display-inline">arouse or gratify the sexual desire of any person.</text></clause></subparagraph><subparagraph id="H55DC2B3EA1244CC0A49AF26B42BE8859" commented="no" display-inline="no-display-inline"><enum>(C)</enum><header display-inline="yes-display-inline">Exceptions</header><text display-inline="yes-display-inline">Subparagraphs (A) and (B) shall not apply to—</text><clause id="HC77546219FC8406F8A5E600E3621BDD0" commented="no" display-inline="no-display-inline"><enum>(i)</enum><text display-inline="yes-display-inline">a lawfully authorized investigative, protective, or intelligence activity of—</text><subclause id="H7131B13684D140DFACD048050E45B5F2" commented="no" display-inline="no-display-inline"><enum>(I)</enum><text display-inline="yes-display-inline">a law enforcement agency of the United States, a State, or a political subdivision of a State; or</text></subclause><subclause id="HDFA373F4B8E1429E9A32F61BCA93A1BB" commented="no" display-inline="no-display-inline"><enum>(II)</enum><text display-inline="yes-display-inline">an intelligence agency of the United States;</text></subclause></clause><clause id="H35C5A2BC4BD54C4981BE51C8F63ABBEC" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text display-inline="yes-display-inline">a disclosure made reasonably and in good faith—</text><subclause id="H1629651036764474B494DF76CE65A2DE" commented="no" display-inline="no-display-inline"><enum>(I)</enum><text display-inline="yes-display-inline">to a law enforcement officer or agency;</text></subclause><subclause id="H4AB76EA45A114AB48E86E902FE4724AB" commented="no" display-inline="no-display-inline"><enum>(II)</enum><text display-inline="yes-display-inline">as part of a document production or filing associated with a legal proceeding;</text></subclause><subclause id="HDB9A2BEFB5714CD1B9A150FADDCEA951" commented="no" display-inline="no-display-inline"><enum>(III)</enum><text display-inline="yes-display-inline">as part of medical education, diagnosis, or treatment or for a legitimate medical, scientific, or education purpose;</text></subclause><subclause id="H31FFD6E75B3E4F4C87DDAB9865BCCFC5" commented="no" display-inline="no-display-inline"><enum>(IV)</enum><text display-inline="yes-display-inline">in the reporting of unlawful content or unsolicited or unwelcome conduct or in pursuance of a legal, professional, or other lawful obligation; or</text></subclause><subclause id="H6EF86211154C4ED9B2520ACFDE7E7FB4" commented="no" display-inline="no-display-inline"><enum>(V)</enum><text display-inline="yes-display-inline">to seek support or help with respect to the receipt of an unsolicited intimate visual depiction;</text></subclause></clause><clause id="H8C6A8280D9B34A72BEEDB981F30C8E00" commented="no" display-inline="no-display-inline"><enum>(iii)</enum><text display-inline="yes-display-inline">a disclosure reasonably intended to assist the identifiable individual; or</text></clause><clause id="HE773F462EA884E7E802ADD037B0296C1" commented="no" display-inline="no-display-inline"><enum>(iv)</enum><text display-inline="yes-display-inline">a person who possesses or publishes a digital forgery of himself or herself engaged in nudity or sexually explicit conduct (as that term is defined in section 2256(2)(A) of title 18, United States Code). </text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3786BF68B5FE441BA715E32C277DA9A9"><enum>(4)</enum><header display-inline="yes-display-inline">Penalties</header><subparagraph commented="no" display-inline="no-display-inline" id="H5A7AF1EC91A94F8CBF6FA1213A96514B"><enum>(A)</enum><header display-inline="yes-display-inline">Offenses involving adults</header><text display-inline="yes-display-inline">Any person who violates paragraph (2)(A) or (3)(A) shall be fined under title 18, United States Code, imprisoned not more than 2 years, or both.</text></subparagraph><subparagraph id="H1CF6C74946F042819AC48009E9607D4F" commented="no" display-inline="no-display-inline"><enum>(B)</enum><header display-inline="yes-display-inline">Offenses involving minors</header><text display-inline="yes-display-inline">Any person who violates paragraph (2)(B) or (3)(B) shall be fined under title 18, United States Code, imprisoned not more than 3 years, or both.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H59E757B09ED14636A5BBEC0B0B16F8B8"><enum>(5)</enum><header display-inline="yes-display-inline">Rules of construction</header><text display-inline="yes-display-inline">For purposes of paragraphs (2) and (3)—</text><subparagraph commented="no" display-inline="no-display-inline" id="HD1DC831FF2F343FB95A97D3F38693575"><enum>(A)</enum><text display-inline="yes-display-inline">the fact that the identifiable individual provided consent for the creation of the intimate visual depiction shall not establish that the individual provided consent for the publication of the intimate visual depiction; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H907D929702424B258C2B0944AFF18EF3"><enum>(B)</enum><text display-inline="yes-display-inline">the fact that the identifiable individual disclosed the intimate visual depiction to another individual shall not establish that the identifiable individual provided consent for the publication of the intimate visual depiction by the person alleged to have violated paragraph (2) or (3), respectively.</text></subparagraph></paragraph><paragraph id="H98837485AADB44468476A3580835EB33" commented="no" display-inline="no-display-inline"><enum>(6)</enum><header display-inline="yes-display-inline">Threats</header><subparagraph commented="no" display-inline="no-display-inline" id="H3C96E43D132540B0970180FB72FE1E23"><enum>(A)</enum><header display-inline="yes-display-inline">Threats involving authentic intimate visual depictions</header><text display-inline="yes-display-inline">Any person who intentionally threatens to commit an offense under paragraph (2) for the purpose of intimidation, coercion, extortion, or to create mental distress shall be punished as provided in paragraph (4).</text></subparagraph><subparagraph id="HBF748ADE54DD4858A87F889724AF43B7" commented="no" display-inline="no-display-inline"><enum>(B)</enum><header display-inline="yes-display-inline">Threats involving digital forgeries</header><clause id="H7CD58BBB38BE467DA4CF485C40F1F563" commented="no" display-inline="no-display-inline"><enum>(i)</enum><header display-inline="yes-display-inline">Threats involving adults</header><text display-inline="yes-display-inline">Any person who intentionally threatens to commit an offense under paragraph (3)(A) for the purpose of intimidation, coercion, extortion, or to create mental distress shall be fined under title 18, United States Code, imprisoned not more than 18 months, or both.</text></clause><clause id="H7E64F7F5579E44CD9993FFA5C304A857" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><header display-inline="yes-display-inline">Threats involving minors</header><text display-inline="yes-display-inline">Any person who intentionally threatens to commit an offense under paragraph (3)(B) for the purpose of intimidation, coercion, extortion, or to create mental distress shall be fined under title 18, United States Code, imprisoned not more than 30 months, or both.</text></clause></subparagraph></paragraph><paragraph id="H5C0A51B4B6BC4F2DB63F0CD46D75A571" commented="no" display-inline="no-display-inline"><enum>(7)</enum><header display-inline="yes-display-inline">Forfeiture</header><subparagraph id="H52C32210A5B7447A9CB7514E37910FF8" commented="no" display-inline="no-display-inline"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The court, in imposing a sentence on any person convicted of a violation of paragraph (2) or (3), shall order, in addition to any other sentence imposed and irrespective of any provision of State law, that the person forfeit to the United States—</text><clause id="H2A442F2F59E247AD8B61FB65C4E6FE19" commented="no" display-inline="no-display-inline"><enum>(i)</enum><text display-inline="yes-display-inline">any material distributed in violation of that paragraph;</text></clause><clause id="H10D8A877CEE34048AB754497CFAAB7E3" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text display-inline="yes-display-inline">the person’s interest in property, real or personal, constituting or derived from any gross proceeds of the violation, or any property traceable to such property, obtained or retained directly or indirectly as a result of the violation; and</text></clause><clause id="H861A7BEFBE3A47F98EA7FEF8E273BE8A" commented="no" display-inline="no-display-inline"><enum>(iii)</enum><text display-inline="yes-display-inline">any personal property of the person used, or intended to be used, in any manner or part, to commit or to facilitate the commission of the violation.</text></clause></subparagraph><subparagraph id="HC16AFD594EAB4B8BB0636DC5EB917951" commented="no" display-inline="no-display-inline"><enum>(B)</enum><header display-inline="yes-display-inline">Procedures</header><text display-inline="yes-display-inline">Section 413 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/853">21 U.S.C. 853</external-xref>), with the exception of subsections (a) and (d), shall apply to the criminal forfeiture of property under subparagraph (A).</text></subparagraph></paragraph><paragraph id="HF6BC4474675C4799AEF9FA93ED2FB32F" commented="no" display-inline="no-display-inline"><enum>(8)</enum><header display-inline="yes-display-inline">Restitution</header><text display-inline="yes-display-inline">The court shall order restitution for an offense under paragraph (2) or (3) in the same manner as under section 2264 of title 18, United States Code.</text></paragraph><paragraph id="H6228966BA85347CD9430582D04AF8AB4" commented="no" display-inline="no-display-inline"><enum>(9)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">Nothing in this subsection shall be construed to limit the application of any other relevant law, including section 2252 of title 18, United States Code.</text></paragraph></subsection><after-quoted-block display="yes">.</after-quoted-block></quoted-block></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H1C42D8C604004FFFA457428A74AE1AE5"><enum>(b)</enum><header display-inline="yes-display-inline">Defenses</header><text display-inline="yes-display-inline">Section 223(e)(1) of the Communications Act of 1934 (<external-xref legal-doc="usc" parsable-cite="usc/47/223">47 U.S.C. 223(e)(1)</external-xref>) is amended by striking <quote>or (d)</quote> and inserting <quote>, (d), or (h)</quote>.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H74F0809AC5DF4D8784D8AD58223CE148"><enum>(c)</enum><header display-inline="yes-display-inline">Technical and conforming amendment</header><text display-inline="yes-display-inline">Subsection (i) of section 223 of the Communications Act of 1934 (<external-xref legal-doc="usc" parsable-cite="usc/47/223">47 U.S.C. 223</external-xref>), as so redesignated by subsection (a), is amended by inserting <quote><header-in-text level="subsection" style="OLC">Definitions</header-in-text>.—</quote> before <quote>For purposes of this section</quote>.</text></subsection></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="HC50CA7D89E5D4CCC965F8F42CF91CA27"><enum>803.</enum><header display-inline="yes-display-inline">Notice and removal of nonconsensual intimate visual depictions</header><subsection commented="no" display-inline="no-display-inline" id="HAEA4DEA56BDD44449F777AAF1D551653"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><paragraph commented="no" display-inline="no-display-inline" id="H24A6FE6E71B54321ACA952BD74522C72"><enum>(1)</enum><header display-inline="yes-display-inline">Notice and removal process</header><subparagraph commented="no" display-inline="no-display-inline" id="H6A284622F6C84992AC0FBCBDCA9F0A23"><enum>(A)</enum><header display-inline="yes-display-inline">Establishment</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of this Act, a covered platform shall establish a process whereby an identifiable individual (or an authorized person acting on behalf of such individual) may—</text><clause commented="no" display-inline="no-display-inline" id="HCB3E5F325F0648A387D3781975411B82"><enum>(i)</enum><text display-inline="yes-display-inline">notify the covered platform of an intimate visual depiction published on the covered platform that—</text><subclause commented="no" display-inline="no-display-inline" id="H00B7989A6FDB47FBBB6DA60D8B4B0F80"><enum>(I)</enum><text display-inline="yes-display-inline">includes a depiction of the identifiable individual; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HFF53F5CD281C4C7880A478E3AAE6F991"><enum>(II)</enum><text display-inline="yes-display-inline">was published without the consent of the identifiable individual; and</text></subclause></clause><clause commented="no" display-inline="no-display-inline" id="H90ABB0AE025041E0B6E72FB5A02D8BCA"><enum>(ii)</enum><text display-inline="yes-display-inline">submit a request for the covered platform to remove such intimate visual depiction.</text></clause></subparagraph><subparagraph id="HC4A99B41E5F341F88A10C3B1DBF59E14" commented="no" display-inline="no-display-inline"><enum>(B)</enum><header display-inline="yes-display-inline">Requirements</header><text display-inline="yes-display-inline">A notification and request for removal of an intimate visual depiction submitted under the process established under subparagraph (A) shall include, in writing—</text><clause commented="no" display-inline="no-display-inline" id="HB544BDE4DBBA4C97A9FBC7B936F44E85"><enum>(i)</enum><text display-inline="yes-display-inline">a physical or electronic signature of the identifiable individual (or an authorized person acting on behalf of such individual); </text></clause><clause commented="no" display-inline="no-display-inline" id="H165FA26AE2D54FE8870801A71E93674E"><enum>(ii)</enum><text display-inline="yes-display-inline">an identification of, and information reasonably sufficient for the covered platform to locate, the intimate visual depiction of the identifiable individual;</text></clause><clause commented="no" display-inline="no-display-inline" id="H8687B90C56ED49B38EA284FB1494DC7A"><enum>(iii)</enum><text display-inline="yes-display-inline">a brief statement that the identifiable individual has a good faith belief that any intimate visual depiction identified under clause (ii) is not consensual, including any relevant information for the covered platform to determine the intimate visual depiction was published without the consent of the identifiable individual; and</text></clause><clause id="H85D5FB3BEB71496CA81418DC9F4558B4" commented="no" display-inline="no-display-inline"><enum>(iv)</enum><text display-inline="yes-display-inline">information sufficient to enable the covered platform to contact the identifiable individual (or an authorized person acting on behalf of such individual).</text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBB37445E16AF4E91B9E661F147977D6B"><enum>(2)</enum><header display-inline="yes-display-inline">Notice of process</header><text display-inline="yes-display-inline">A covered platform shall provide on the platform a clear and conspicuous notice, which may be provided through a clear and conspicuous link to another web page or disclosure, of the notice and removal process established under paragraph (1)(A) that—</text><subparagraph id="HBF93CA3778AD4F4BABBB2223A455F442" commented="no" display-inline="no-display-inline"><enum>(A)</enum><text display-inline="yes-display-inline">is easy to read and in plain language; and</text></subparagraph><subparagraph id="H198A4E251ECC4DC0A4615E93AF25861A" commented="no" display-inline="no-display-inline"><enum>(B)</enum><text display-inline="yes-display-inline">provides information regarding the responsibilities of the covered platform under this section, including a description of how an individual can submit a notification and request for removal.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H67E8B041FB8E4EA2BC5BEA09C01CC82D"><enum>(3)</enum><header display-inline="yes-display-inline">Removal of nonconsensual intimate visual depictions</header><text display-inline="yes-display-inline">Upon receiving a valid removal request from an identifiable individual (or an authorized person acting on behalf of such individual) using the process described in paragraph (1)(A)(ii), a covered platform shall, as soon as possible, but not later than 48 hours after receiving such request—</text><subparagraph commented="no" display-inline="no-display-inline" id="HBA39C4A2C6CD44E9B6080890A9BB002E"><enum>(A)</enum><text display-inline="yes-display-inline">remove the intimate visual depiction; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H39B6AB605EA4421186F46A83F2E5C955"><enum>(B)</enum><text display-inline="yes-display-inline">make reasonable efforts to identify and remove any known identical copies of such depiction.</text></subparagraph></paragraph><paragraph id="HFA1F0E8D122D4D5A996077359C0E665F" commented="no" display-inline="no-display-inline"><enum>(4)</enum><header display-inline="yes-display-inline">Limitation on liability</header><text display-inline="yes-display-inline">A covered platform shall not be liable for any claim based on the covered platform’s good faith disabling of access to, or removal of, material claimed to be a nonconsensual intimate visual depiction based on facts or circumstances from which the unlawful publishing of an intimate visual depiction is apparent, regardless of whether the intimate visual depiction is ultimately determined to be unlawful or not. </text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H7C97BD24DB9E4406AC031A5699CC5DC3"><enum>(b)</enum><header display-inline="yes-display-inline">Enforcement by the Commission</header><paragraph id="H3AA669B8E838487EA6366406A5CE68A3" commented="no" display-inline="no-display-inline"><enum>(1)</enum><header display-inline="yes-display-inline">Unfair or deceptive acts or practices</header><text display-inline="yes-display-inline">A failure to reasonably comply with the notice and takedown obligations under subsection (a) shall be treated as a violation of a rule defining an unfair or a deceptive act or practice under section 18(a)(1)(B) of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/57a">15 U.S.C. 57a(a)(1)(B)</external-xref>).</text></paragraph><paragraph id="H0903151553DE490C919E15281B7E5936" commented="no" display-inline="no-display-inline"><enum>(2)</enum><header display-inline="yes-display-inline">Powers of the Commission</header><subparagraph id="H23AFC897A4D744CBA269C5B6B5F61F9F" commented="no" display-inline="no-display-inline"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Except as provided in subparagraph (D), the Commission shall enforce this section in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/41">15 U.S.C. 41 et seq.</external-xref>) were incorporated into and made a part of this section.</text></subparagraph><subparagraph id="H60DB2FB6E5454554A600EB8D12A2749A" commented="no" display-inline="no-display-inline"><enum>(B)</enum><header display-inline="yes-display-inline">Privileges and immunities</header><text display-inline="yes-display-inline">Any person who violates this section shall be subject to the penalties and entitled to the privileges and immunities provided in the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/41">15 U.S.C. 41 et seq.</external-xref>).</text></subparagraph><subparagraph id="H5F25242A103A42CA89AC9974C685DF50" commented="no" display-inline="no-display-inline"><enum>(C)</enum><header display-inline="yes-display-inline">Authority preserved</header><text display-inline="yes-display-inline">Nothing in this title shall be construed to limit the authority of the Federal Trade Commission under any other provision of law.</text></subparagraph><subparagraph id="H2A8E8960B14A4174A0372877070B776D" commented="no" display-inline="no-display-inline"><enum>(D)</enum><header display-inline="yes-display-inline">Scope of jurisdiction</header><text display-inline="yes-display-inline">Notwithstanding sections 4, 5(a)(2), or 6 of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/44">15 U.S.C. 44</external-xref>; 45(a)(2); 46), or any jurisdictional limitation of the Commission, the Commission shall also enforce this section in the same manner provided in subparagraph (A), with respect to organizations that are not organized to carry on business for their own profit or that of their members.</text></subparagraph></paragraph></subsection></section><section id="H404560771A1C41AF9D32769558EA43A8" commented="no" display-inline="no-display-inline" section-type="subsequent-section"><enum>804.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">In this title:</text><paragraph commented="no" display-inline="no-display-inline" id="H65848F71599443D3A747A8D95CA2C055"><enum>(1)</enum><header display-inline="yes-display-inline">Commission</header><text display-inline="yes-display-inline">The term <term>Commission</term> means the Federal Trade Commission.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF4B1B33B1F334C59B7791584A516346A"><enum>(2)</enum><header display-inline="yes-display-inline">Consent; digital forgery; identifiable individual; intimate visual depiction</header><text display-inline="yes-display-inline">The terms <term>consent</term>, <term>digital forgery</term>, <term>identifiable individual</term>, <term>intimate visual depiction</term>, and <term>minor</term> have the meaning given such terms in section 223(h) of the Communications Act of 1934 (<external-xref legal-doc="usc" parsable-cite="usc/47/223">47 U.S.C. 223(h)</external-xref>), as added by section 802.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC60EB609EECD4634AF97CE97351A1A18"><enum>(3)</enum><header display-inline="yes-display-inline">Covered platform</header><subparagraph commented="no" display-inline="no-display-inline" id="HD33C97E1A8F844A18191808625D9BE7B"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The term <term>covered platform</term> means a website, online service, online application, or mobile application—</text><clause commented="no" display-inline="no-display-inline" id="H6F7CC7B48FAE4296B419A07333E73534"><enum>(i)</enum><text display-inline="yes-display-inline">that serves the public; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H25798ACA6086477BA54B79DE9B23C020"><enum>(ii)</enum><subclause commented="no" display-inline="yes-display-inline" id="HD695BAA4C6BA4414962CABBE486F3720"><enum>(I)</enum><text display-inline="yes-display-inline">that primarily provides a forum for user-generated content, including messages, videos, images, games, and audio files; or</text></subclause><subclause id="H9C3ACF16B45543CAA54BF1E5EAE3D4E5" indent="up1" commented="no" display-inline="no-display-inline"><enum>(II)</enum><text display-inline="yes-display-inline">for which it is in the regular course of trade or business of the website, online service, online application, or mobile application to publish, curate, host, or make available content of nonconsensual intimate visual depictions.</text></subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD3A533AF88884B529899BE9539EB29BA"><enum>(B)</enum><header display-inline="yes-display-inline">Exclusions</header><text display-inline="yes-display-inline">The term <term>covered platform</term> shall not include the following:</text><clause id="HCF400D4E573F4652A888896B30C0EB1A" commented="no" display-inline="no-display-inline"><enum>(i)</enum><text display-inline="yes-display-inline">A provider of broadband internet access service (as described in section 8.1(b) of title 47, Code of Federal Regulations, or successor regulation).</text></clause><clause id="HC9EC1796F9D44B918E3197887E4814EC" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text display-inline="yes-display-inline">Electronic mail.</text></clause><clause id="H152966B4E81F41F09CDA0185A792152E" commented="no" display-inline="no-display-inline"><enum>(iii)</enum><text display-inline="yes-display-inline">Except as provided in subparagraph (A)(ii)(II), an online service, application, or website—</text><subclause id="H889CC3A8980E450496DA2048F3F02291" commented="no" display-inline="no-display-inline"><enum>(I)</enum><text display-inline="yes-display-inline">that consists primarily of content that is not user generated but is preselected by the provider of such online service, application, or website; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H1640B06D36AD478E9DF9AFA9DCF7D4C0"><enum>(II)</enum><text display-inline="yes-display-inline">for which any chat, comment, or interactive functionality is incidental to, directly related to, or dependent on the provision of the content described in subparagraph (A)(ii)(I).</text></subclause></clause></subparagraph></paragraph></section><section id="HBD288E699EA9479EB343A83516492211" commented="no" display-inline="no-display-inline" section-type="subsequent-section"><enum>805.</enum><header display-inline="yes-display-inline">Severability</header><text display-inline="no-display-inline">If any provision of this title, or an amendment made by this title, is determined to be unenforceable or invalid, the remaining provisions of this title and the amendments made by this title shall not be affected.</text></section></title><title id="H81CB3699195941008029C8E3818EFCD0" style="OLC" commented="no"><enum>IX</enum><header>Rural Broadband Protection Act</header><section id="H277E1704C2474506BA565003925E2B88" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>901.</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Rural Broadband Protection Act</quote>.</text></section><section section-type="subsequent-section" id="HFDC4FE70AB4A41CF947EBCC613FDD1EE" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>902.</enum><header display-inline="yes-display-inline">Vetting process for prospective high-cost universal service fund applicants</header><text display-inline="no-display-inline">Section 254 of the Communications Act of 1934 (<external-xref legal-doc="usc" parsable-cite="usc/47/254">47 U.S.C. 254</external-xref>) is amended by adding at the end the following:</text><quoted-block id="H1BBF0FFD26C146109F99AB82F2873711" changed="not-changed" display-inline="no-display-inline" style="OLC"><subsection id="H97326C3F2D494B7FA8984CF28B8FA67C" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(m)</enum><header display-inline="yes-display-inline">Vetting of High-Cost fund recipients</header><paragraph commented="no" display-inline="no-display-inline" id="H50B976A636D041569EAE3E47C2B9A047" changed="not-changed"><enum>(1)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this subsection—</text><subparagraph id="HF49E9B1E08BC483D8CC3076E7A183DE3" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(A)</enum><text display-inline="yes-display-inline">the term <term>covered funding</term> means any new offer of high-cost universal service program funding, including funding provided through a reverse competitive bidding mechanism provided under this section, for the deployment of a broadband-capable network and the provision of supported services over the network; and</text></subparagraph><subparagraph id="HA22D520CA74148FF859FB31ED12C4FFF" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(B)</enum><text display-inline="yes-display-inline">the term <term>new covered funding award</term> means an award of covered funding that is made based on an application submitted to the Commission on or after the date on which rules are promulgated under paragraph (2).</text></subparagraph></paragraph><paragraph id="H43479261E5A043C8B8CB739A91D39E90" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(2)</enum><header display-inline="yes-display-inline">Commission rulemaking</header><text display-inline="yes-display-inline">Not later than 180 days after the date of enactment of this subsection, the Commission shall initiate a rulemaking proceeding to establish a vetting process for applicants for, and other recipients of, a new covered funding award.</text></paragraph><paragraph id="HC0EA230C69304B17905EBD959714A32D" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(3)</enum><header display-inline="yes-display-inline">Contents</header><subparagraph commented="no" display-inline="no-display-inline" id="HA9B4B5B99F2E4D42964B6D034C2C0EA4" changed="not-changed"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">In promulgating rules under paragraph (2), the Commission shall provide that, consistent with principles of technology neutrality, the Commission will only award covered funding to applicants that can demonstrate that they meet the qualifications in subparagraph (B).</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H9D6901138F264DE3BA8E314D89418E08" changed="not-changed"><enum>(B)</enum><header display-inline="yes-display-inline">Qualifications described</header><text display-inline="yes-display-inline">An applicant for a new covered funding award shall include in the initial application a proposal containing sufficient detail and documentation for the Commission to ascertain that the applicant possesses the technical, financial, and operational capabilities, and has a reasonable business plan, to deploy the proposed network and deliver services with the relevant performance characteristics and requirements defined by the Commission and as pledged by the applicant.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H222361AEB3ED4A21879369523F9F3F5D" changed="not-changed"><enum>(C)</enum><header display-inline="yes-display-inline">Evaluation of proposal</header><text display-inline="yes-display-inline">The Commission shall evaluate a proposal described in subparagraph (B) against— </text><clause commented="no" display-inline="no-display-inline" id="H0EE96AB5B10F44089CF34B42FD2553EF" changed="not-changed"><enum>(i)</enum><text display-inline="yes-display-inline">reasonable and well-established technical, financial, and operational standards, including the technical standards adopted by the Commission in orders of the Commission relating to Establishing the Digital Opportunity Data Collection (WC Docket No. 19–195) (or orders of the Commission relating to modernizing any successor collection) for purposes of entities that must report broadband availability coverage; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H37B92C01885B48BB916F517AAE0F4F38" changed="not-changed"><enum>(ii)</enum><text display-inline="yes-display-inline">the applicant’s history of complying with requirements in Commission and other government broadband deployment funding programs.</text></clause></subparagraph><subparagraph id="HA58298350A7046FCA797C01A37F6B8CF" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(D)</enum><header display-inline="yes-display-inline">Penalties for pre-authorization defaults</header><text display-inline="yes-display-inline">In adopting rules for any new covered funding award, the Commission shall set a penalty for pre-authorization defaults of at least $9,000 per violation and may not limit the base forfeiture to an amount less than 30 percent of the applicant’s total support, unless the Commission demonstrates the need for lower penalties in a particular instance.</text></subparagraph></paragraph></subsection><after-quoted-block display="yes">.</after-quoted-block></quoted-block></section></title><title id="H3151FD29F62943148C1B17579BDE5A16" style="OLC" commented="no"><enum>X</enum><header>American Music Tourism</header><section id="H3F96853B4E004B43AC51E601F9F5F93F" section-type="subsequent-section" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>1001.</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>American Music Tourism Act</short-title></quote>.</text></section><section commented="no" display-inline="no-display-inline" id="HDCC4BB7869BB442EB890E2BC92A418C5" changed="not-changed" section-type="subsequent-section"><enum>1002.</enum><header display-inline="yes-display-inline">Responsibilities of the Assistant Secretary of Commerce for Travel and Tourism</header><subsection commented="no" display-inline="no-display-inline" id="H930CD7A7FA9A4CEC97184DA8FC8CFC6B" changed="not-changed"><enum>(a)</enum><header display-inline="yes-display-inline">Domestic travel and tourism</header><text display-inline="yes-display-inline">Section 605(b) of the Visit America Act (<external-xref legal-doc="usc" parsable-cite="usc/15/9803">15 U.S.C. 9803(b)</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H320E1D4EE7FF4F84B6FA68CA62C7A1ED" changed="not-changed"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (2), by striking <quote>; and</quote> and inserting a semicolon; </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBED85AF9496D4DB3B40AE9F7CB34B12F" changed="not-changed"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (3), by striking the period at the end and inserting <quote>; and</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H57700C1260FA4E829F624CFF11D14B00" changed="not-changed"><enum>(3)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HA83974618EB94B409BCDD40CAC68EE0A" changed="not-changed"><paragraph commented="no" display-inline="no-display-inline" id="H83C94A695681445998B155614E138E95" changed="not-changed"><enum>(4)</enum><text display-inline="yes-display-inline">identify locations and events in the United States that are important to music tourism and facilitate and promote domestic travel and tourism to those locations and events.</text></paragraph><after-quoted-block display="yes">.</after-quoted-block></quoted-block></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H61F72544003E4EDA96FA981B826E79BA" changed="not-changed"><enum>(b)</enum><header display-inline="yes-display-inline">Facilitation of international business and leisure travel</header><text display-inline="yes-display-inline">Section 605 of the Visit America Act (<external-xref legal-doc="usc" parsable-cite="usc/15/9803">15 U.S.C. 9803</external-xref>) is amended by striking subsection (d) and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HF1A38987C07C4BEEAC2DAEAC04225F49" changed="not-changed"><subsection commented="no" display-inline="no-display-inline" id="H08EFF4F83C534CE587208E05085B4BCD" changed="not-changed"><enum>(d)</enum><header display-inline="yes-display-inline">Facilitation of international business and leisure travel</header><text display-inline="yes-display-inline">The Assistant Secretary, in coordination with relevant Federal agencies, shall strive to increase and facilitate international business and leisure travel to the United States and ensure competitiveness by—</text><paragraph commented="no" display-inline="no-display-inline" id="H1219F3BE706348589278012B03DC41A0" changed="not-changed"><enum>(1)</enum><text display-inline="yes-display-inline">facilitating large meetings, incentives, conferences, and exhibitions in the United States;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB57AB3EDCC8541C0B2E62CC84E177D47" changed="not-changed"><enum>(2)</enum><text display-inline="yes-display-inline">emphasizing rural and other destinations in the United States that are rich in cultural heritage or ecological tourism, among other uniquely American destinations, as locations for hosting international meetings, incentives, conferences, and exhibitions;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H657F5BF0C2274BE2B2D0298CA68A12D4" changed="not-changed"><enum>(3)</enum><text display-inline="yes-display-inline">facilitating and promoting international travel and tourism to sports and recreation events and activities in the United States; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0458ADD19F314D339505D59AB414DED5" changed="not-changed"><enum>(4)</enum><text display-inline="yes-display-inline">identifying locations and events in the United States that are important to music tourism and facilitating and promoting international travel and tourism to those locations and events.</text></paragraph></subsection><after-quoted-block display="yes">.</after-quoted-block></quoted-block></subsection><subsection commented="no" display-inline="no-display-inline" id="H74183A1123024E14BCA8DA8198D364AA" changed="not-changed"><enum>(c)</enum><header display-inline="yes-display-inline">Reporting requirements</header><text display-inline="yes-display-inline">Section 605(f) of the Visit America Act (<external-xref legal-doc="usc" parsable-cite="usc/15/9803">15 U.S.C. 9803(f)</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H8365AFD016AD4617B006342C7F085388" changed="not-changed"><paragraph commented="no" display-inline="no-display-inline" id="H50A67253C4E24479BBEBD217639DE1B2" changed="not-changed"><enum>(4)</enum><header display-inline="yes-display-inline">Report on goals relating to domestic and international travel</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of the American Music Tourism Act, and every 2 years thereafter, the Assistant Secretary shall submit to the Subcommittee on Tourism, Trade, and Export Promotion of the Committee on Commerce, Science, and Transportation of the Senate and the Subcommittee on Innovation, Data, and Commerce of the Committee on Energy and Commerce of the House of Representatives a report of activities, findings, achievements, and vulnerabilities relating to the goals described in subsections (a) through (d).</text></paragraph><after-quoted-block display="yes">.</after-quoted-block></quoted-block></subsection><subsection commented="no" display-inline="no-display-inline" id="H19FA13863A63420EB8A196863E514762" changed="not-changed"><enum>(d)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">Section 600 of title VI of division BB of the Consolidated Appropriations Act, 2023 (<external-xref legal-doc="usc" parsable-cite="usc/15/9801">15 U.S.C. 9801</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H039B89DD4FD84B9F88F06DB60120CABC" changed="not-changed"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively, and adjusting the margins accordingly; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H178B18E6167D424E9CEAEECA3868DE4B" changed="not-changed"><enum>(2)</enum><text display-inline="yes-display-inline">by striking <quote>In this title, the term <term>COVID–19 public health emergency</term>—</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HEBCFE97FF0F04A7AAD572585A0FB98E9" changed="not-changed"><subsection commented="no" display-inline="no-display-inline" id="H38299BCFE25A4BEC8A2140483B758FF9" changed="not-changed"><enum/><text display-inline="yes-display-inline">In this title:</text><paragraph commented="no" display-inline="no-display-inline" id="HD7E7327EA0D549C2B14CBB7B09155341" changed="not-changed"><enum>(1)</enum><header display-inline="yes-display-inline">COVID–19 public health emergency</header><text display-inline="yes-display-inline">The term <term>COVID–19 public health emergency</term>—</text></paragraph></subsection><after-quoted-block display="yes">; and</after-quoted-block></quoted-block></paragraph><paragraph id="H8C8DA50D326441EB81E5A934C9B2FC4C" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(3)</enum><text display-inline="yes-display-inline">by adding at the end the following: </text><quoted-block id="H74AC92FB43AC448B9C5330378EA7DBB3" changed="not-changed" display-inline="no-display-inline" style="OLC"><paragraph commented="no" display-inline="no-display-inline" id="H56723034BCE344BF8AF441C22DE61E13" changed="not-changed"><enum>(2)</enum><header display-inline="yes-display-inline">Music tourism</header><text display-inline="yes-display-inline">The term <term>music tourism</term> means—</text><subparagraph id="HD524B7708EBE4A9F997E072C43AAE53F" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(A)</enum><text display-inline="yes-display-inline">the act of traveling to a State or locality to visit historic or modern day music-related attractions, including museums, studios, venues of all sizes, and other sites related to music; or</text></subparagraph><subparagraph id="H31A3252E8E7244C48E834988BAB00257" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(B)</enum><text display-inline="yes-display-inline">the act of traveling to a State or locality to attend a music festival, a concert, or other live musical performance or music-related special event.</text></subparagraph></paragraph><after-quoted-block display="yes">.</after-quoted-block></quoted-block></paragraph></subsection></section></title><title id="HCCF8E7608FA2499FA9841F328C6AFFF3" style="OLC" commented="no"><enum>XI</enum><header>Informing Consumers about Smart Devices</header><section id="H2BC8C4AF062A481BB592F34B679C677A" commented="no"><enum>1101.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Informing Consumers about Smart Devices Act</quote>.</text></section><section id="HBE279CD7072F40B190C4A3AF9232BED9" commented="no"><enum>1102.</enum><header>Required disclosure of a camera or recording capability in certain internet-connected devices</header><text display-inline="no-display-inline">Each manufacturer of a covered device shall disclose, clearly and conspicuously and prior to purchase, whether the covered device manufactured by the manufacturer contains a camera or microphone as a component of the covered device. </text></section><section id="H151FC74A1B424D0884BD4FE4F9F1F4BC" commented="no"><enum>1103.</enum><header>Enforcement by the Federal Trade Commission</header><subsection id="H496B73F3D48242058F6E6EEDA82E7701" commented="no"><enum>(a)</enum><header>Unfair or deceptive acts or practices</header><text>A violation of section 1102 shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under section 18(a)(1)(B) of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/57a">15 U.S.C. 57a(a)(1)(B)</external-xref>).</text></subsection><subsection id="HF6B83DDD0DA140819DCC4863C0E3C76D" commented="no"><enum>(b)</enum><header>Actions by the Commission</header><paragraph id="H0D94BB0345ED4EF88CFB587D5E30C70C" commented="no"><enum>(1)</enum><header>In general</header><text>The Federal Trade Commission (in this title referred to as the <quote>Commission</quote>) shall enforce this title in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/41">15 U.S.C. 41 et seq.</external-xref>) were incorporated into and made a part of this title.</text></paragraph><paragraph id="H249BDFFA51364E929F75D638B490878F" commented="no"><enum>(2)</enum><header>Penalties and privileges</header><text>Any person who violates this title or a regulation promulgated under this title shall be subject to the penalties and entitled to the privileges and immunities provided in the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/41">15 U.S.C. 41 et seq.</external-xref>).</text></paragraph><paragraph id="H3ABCB6AA417349DD9D45D042C0FF90A2" commented="no"><enum>(3)</enum><header>Savings clause</header><text>Nothing in this title shall be construed to limit the authority of the Commission under any other provision of law. </text></paragraph></subsection><subsection id="HE8C3483B4B8149C0BD7BC5F20CB7B3B4" commented="no"><enum>(c)</enum><header>Commission guidance</header><text display-inline="yes-display-inline">Not later than 180 days after the date of enactment of this title, the Commission, through outreach to relevant private entities, shall issue guidance to assist manufacturers in complying with the requirements of this title, including guidance about best practices for making the disclosure required by section 1102 as clear and conspicuous and age appropriate as practicable and about best practices for the use of a pictorial (as defined in section 2(a) of the Consumer Review Fairness Act of 2016 (<external-xref legal-doc="usc" parsable-cite="usc/15/45b">15 U.S.C. 45b(a)</external-xref>)) visual representation of the information to be disclosed.</text></subsection><subsection id="H65DF7B972C23410B9AF5A7139AB00108" commented="no"><enum>(d)</enum><header>Tailored guidance</header><text>A manufacturer of a covered device may petition the Commission for tailored guidance as to how to meet the requirements of section 1102 consistent with existing rules of practice or any successor rules. </text></subsection><subsection id="HD1C348147C9D4ADD9D69C71D514EEC45" commented="no"><enum>(e)</enum><header>Limitation on Commission Guidance</header><text>No guidance issued by the Commission with respect to this title shall confer any rights on any person, State, or locality, nor shall operate to bind the Commission or any person to the approach recommended in such guidance. In any enforcement action brought pursuant to this title, the Commission shall allege a specific violation of a provision of this title. The Commission may not base an enforcement action on, or execute a consent order based on, practices that are alleged to be inconsistent with any such guidelines, unless the practices allegedly violate section 1102.</text></subsection></section><section id="HB55ADC0A46B24BFF85C10F3E45E5380C" commented="no"><enum>1104.</enum><header>Definition of covered device</header><text display-inline="no-display-inline">As used in this title, the term <term>covered device</term>—</text><paragraph id="HCE98AB4130FC463ABB8B1CFF8417F606" commented="no"><enum>(1)</enum><text display-inline="yes-display-inline">means a consumer product, as defined by section 3(a) of the Consumer Product Safety Act (<external-xref legal-doc="usc" parsable-cite="usc/15/2052">15 U.S.C. 2052(a)</external-xref>) that is capable of connecting to the internet, a component of which is a camera or microphone; and</text></paragraph><paragraph id="HB7A20C8DCE3A4D50B741E45F2EFC4FBF" commented="no"><enum>(2)</enum><text>does not include—</text><subparagraph id="HF25AADBC548D46C0849A329DBB1BA36E" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">a telephone (including a mobile phone), a laptop, tablet, or any device that a consumer would reasonably expect to have a microphone or camera;</text></subparagraph><subparagraph id="HA04DB91F955E4AE798DC3D5A24882375" commented="no"><enum>(B)</enum><text>any device that is specifically marketed as a camera, telecommunications device, or microphone; or</text></subparagraph><subparagraph id="HC8FA2DB7DBE34F5096C54F06CEC0245B" commented="no"><enum>(C)</enum><text>any device or apparatus described in sections 255, 716, and 718, and subsections (aa) and (bb) of section 303 of the Communications Act of 1934 (<external-xref legal-doc="usc" parsable-cite="usc/47/255">47 U.S.C. 255</external-xref>; 617; 619; and 303(aa) and (bb)), and any regulations promulgated thereunder.</text></subparagraph></paragraph></section><section id="H092EC9DBBC2D463EA0201FAFDEBB4119" commented="no" display-inline="no-display-inline" section-type="subsequent-section"><enum>1105.</enum><header>Effective date</header><text display-inline="no-display-inline">This title shall apply to all covered devices manufactured after the date that is 180 days after the date on which guidance is issued by the Commission under section 1103(c), and shall not apply to covered devices manufactured or sold before such date, or otherwise introduced into interstate commerce before such date.</text></section></title><title id="H9CA8B99A0DA3441C9DB9BDE3931CCEAC" style="OLC" commented="no"><enum>XII</enum><header>Securing Semiconductor Supply Chains Act</header><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="H8862BB0D49D84B37AEF1F0DE12D7C88A" changed="not-changed"><enum>1201.</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Securing Semiconductor Supply Chains Act<short-title></short-title></quote>.</text></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="H8F14E27660A74676BCBA030D3456072F" changed="not-changed"><enum>1202.</enum><header display-inline="yes-display-inline">SelectUSA defined</header><text display-inline="no-display-inline">In this title, the term <term>SelectUSA</term> means the SelectUSA program of the Department of Commerce established by Executive Order 13577 (76 Fed. Reg. 35715; relating to establishment of the SelectUSA Initiative).</text></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="H9EFAD75C87F8457CB5F7CFEA87B991A9" changed="not-changed"><enum>1203.</enum><header display-inline="yes-display-inline">Findings</header><text display-inline="no-display-inline">Congress makes the following findings:</text><paragraph commented="no" display-inline="no-display-inline" id="HEFE03FD0D88145AA83077AAE52D54A6C" changed="not-changed"><enum>(1)</enum><text display-inline="yes-display-inline">Semiconductors underpin the United States and global economies, including manufacturing sectors. Semiconductors are also essential to the national security of the United States.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H34E94440AAFD420AB70928678362417B" changed="not-changed"><enum>(2)</enum><text display-inline="yes-display-inline">A shortage of semiconductors, brought about by the COVID–19 pandemic and other complex factors impacting the overall supply chain, has threatened the economic recovery of the United States and industries that employ millions of United States citizens.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H39B471385B7A43E9A1C956E29706782A" changed="not-changed"><enum>(3)</enum><text display-inline="yes-display-inline">Addressing current challenges and building resilience against future risks requires ensuring a secure and stable supply chain for semiconductors that will support the economic and national security needs of the United States and its allies.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H645CA113464C4262A2A8E7F9289C62D0" changed="not-changed"><enum>(4)</enum><text display-inline="yes-display-inline">The supply chain for semiconductors is complex and global. While the United States plays a leading role in certain segments of the semiconductor industry, securing the supply chain requires onshoring, reshoring, or diversifying vulnerable segments, such as for—</text><subparagraph commented="no" display-inline="no-display-inline" id="H9C85B6EF0E294E1D9D70BBE3FFC450BB" changed="not-changed"><enum>(A)</enum><text display-inline="yes-display-inline">fabrication;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA66AF201AE7A4B589FD056ECB83D82FC" changed="not-changed"><enum>(B)</enum><text display-inline="yes-display-inline">advanced packaging; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBE4AB7510B3143EE9A3C371E27B4A6B6" changed="not-changed"><enum>(C)</enum><text display-inline="yes-display-inline">materials and equipment used to manufacture semiconductor products.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF2B3F7B691A343A2AC8471276FEB8068" changed="not-changed"><enum>(5)</enum><text display-inline="yes-display-inline">The Federal Government can leverage foreign direct investment and private dollars to grow the domestic manufacturing and production capacity of the United States for vulnerable segments of the semiconductor supply chain.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF93B04DCC2DF42BAA89295643EA0FEB3" changed="not-changed"><enum>(6)</enum><text display-inline="yes-display-inline">The SelectUSA program of the Department of Commerce, in coordination with other Federal agencies and State-level economic development organizations, is positioned to boost foreign direct investment in domestic manufacturing and to help secure the semiconductor supply chain of the United States.</text></paragraph></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="H72A8B2A5B531463194C75F383E01B489" changed="not-changed"><enum>1204.</enum><header display-inline="yes-display-inline">Coordination with State-level economic development organizations</header><text display-inline="no-display-inline">Not later than 180 days after the date of the enactment of this Act, the Executive Director of SelectUSA shall solicit comments from State-level economic development organizations—</text><paragraph commented="no" display-inline="no-display-inline" id="H31A7E5FDC1284D87A853046599FF5B35" changed="not-changed"><enum>(1)</enum><text display-inline="yes-display-inline">to review—</text><subparagraph commented="no" display-inline="no-display-inline" id="HA2E16EB8716E474C9EEA02D72278D2FD" changed="not-changed"><enum>(A)</enum><text display-inline="yes-display-inline">what efforts the Federal Government can take to support increased foreign direct investment in any segment of semiconductor-related production;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8BE352C77839420BAED4F8374D3BCC8C" changed="not-changed"><enum>(B)</enum><text display-inline="yes-display-inline">what barriers to such investment may exist and how to amplify State efforts to attract such investment;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H353E586EB7BD4EEFB026B5A92B37745B" changed="not-changed"><enum>(C)</enum><text display-inline="yes-display-inline">public opportunities those organizations have identified to attract foreign direct investment to help increase investment described in subparagraph (A); and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB1F91663EA8F459885474CD14A574597" changed="not-changed"><enum>(D)</enum><text display-inline="yes-display-inline">resource gaps or other challenges that prevent those organizations from increasing such investment; and</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9C4DE4C30486489ABAD897EFF6A7B634" changed="not-changed"><enum>(2)</enum><text display-inline="yes-display-inline">to develop recommendations for—</text><subparagraph commented="no" display-inline="no-display-inline" id="HDDC5179225414076BD793E1FE2A053BA" changed="not-changed"><enum>(A)</enum><text display-inline="yes-display-inline">how SelectUSA can increase such investment independently or through partnership with those organizations; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H8C0D9394A5934A14BBC5DDA5535D6BD1" changed="not-changed"><enum>(B)</enum><text display-inline="yes-display-inline">working with countries that are allies or partners of the United States to ensure that foreign adversaries (as defined in section 8(c)(2) of the Secure and Trusted Communications Networks Act of 2019 (<external-xref legal-doc="usc" parsable-cite="usc/47/1607">47 U.S.C. 1607(c)(2)</external-xref>)) do not benefit from United States efforts to increase such investment.</text></subparagraph></paragraph></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="HB6CBBE6221F44932B2FC5DE18E5F52CF" changed="not-changed"><enum>1205.</enum><header display-inline="yes-display-inline">Report on increasing foreign direct investment in semiconductor-related manufacturing and production</header><text display-inline="no-display-inline">Not later than 2 years after the date of the enactment of this Act, the Executive Director of SelectUSA, in coordination with the Federal Interagency Investment Working Group established by Executive Order 13577 (76 Fed. Reg. 35715; relating to establishment of the SelectUSA Initiative), shall submit to the Committee on Commerce, Science, and Transportation of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes—</text><paragraph commented="no" display-inline="no-display-inline" id="H2CCFF258F56749329EC6D4B29BC25CC8" changed="not-changed"><enum>(1)</enum><text display-inline="yes-display-inline">a review of the comments SelectUSA received from State-level economic development organizations under section 1204;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H186F8E4741FB426A84D9719C3F45EA48" changed="not-changed"><enum>(2)</enum><text display-inline="yes-display-inline">a description of activities SelectUSA is engaged in to increase foreign direct investment in semiconductor-related manufacturing and production; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H48EED4D8A3DE4A53A737A94AED4BC25C" changed="not-changed"><enum>(3)</enum><text display-inline="yes-display-inline">an assessment of strategies SelectUSA may implement to achieve an increase in such investment and to help secure the United States supply chain for semiconductors, including by—</text><subparagraph commented="no" display-inline="no-display-inline" id="HE2E282A36EED4218A2D789E3B94CA37E" changed="not-changed"><enum>(A)</enum><text display-inline="yes-display-inline">working with other relevant Federal agencies; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H59EF0E65DACC479DA00A38DDB43A1F1D" changed="not-changed"><enum>(B)</enum><text display-inline="yes-display-inline">working with State-level economic development organizations and implementing any strategies or recommendations SelectUSA received from those organizations.</text></subparagraph></paragraph></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="H47D94096E7B9475BAF80C349E362EB6C" changed="not-changed"><enum>1206.</enum><header display-inline="yes-display-inline">No additional funds</header><text display-inline="no-display-inline">No additional funds are authorized to be appropriated for the purpose of carrying out this title. The Executive Director of SelectUSA shall carry out this title using amounts otherwise available to the Executive Director for such purposes.</text></section></title><title id="H874599F68A3F44F583C95DE7F6E326EE" style="OLC"><enum>XIII</enum><header>Hotel Fees Transparency Act</header><section section-type="subsequent-section" commented="no" display-inline="no-display-inline" id="H1BDF90ACEAFF4F648C2B92E04A597D55"><enum>1301.</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Hotel Fees Transparency Act</quote>.</text></section><section id="HFBEADFE9EB6845BDBAC57CDB92C4DC63"><enum>1302.</enum><header>Prohibition on unfair and deceptive advertising of hotel rooms and other short-term rental prices</header><subsection id="H4F7FB2F5E3164241AB29E40663D3CBC6"><enum>(a)</enum><header>Prohibition</header><paragraph commented="no" display-inline="no-display-inline" id="H30CBF7A6FE394B818EB1EFD657033CE1"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">It shall be unlawful for a covered entity to display, advertise, market, or offer in interstate commerce, including through direct offerings, third-party distribution, or metasearch referrals, a price for covered services that does not clearly, conspicuously, and prominently—</text><subparagraph commented="no" display-inline="no-display-inline" id="H14CB2F7CC9ED42BFA74DB909A427FA80"><enum>(A)</enum><text display-inline="yes-display-inline">display the total services price, if a price is displayed, in any advertisement, marketing, or price list wherever the covered services are displayed, advertised, marketed, or offered for sale; </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7E52771E76684535BFD65D9F89FD502B"><enum>(B)</enum><text>disclose to any individual who seeks to purchase covered services the total services price at the time the covered services are first displayed to the individual and anytime thereafter throughout the covered services purchasing process; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H29BA27ED08194277B2DF1FDBFB168F4B"><enum>(C)</enum><text>disclose, prior to the final purchase, any tax, fee, or assessment imposed by any government entity, quasi-government entity, or government-created special district or program on the sale of covered services.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H08D031A6B63C4103AA736A89D4868046"><enum>(2)</enum><header>Individual components</header><text display-inline="yes-display-inline">Provided that such displays are less prominent than the total service price required in paragraph (1), nothing in this Act shall be construed to prohibit the display of— </text><subparagraph commented="no" display-inline="no-display-inline" id="HD532992133A84D3B9F803B3375DBC269"><enum>(A)</enum><text>individual components of the total price; or</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H18CB247B7C8B4B52A209B62F6AB577E9"><enum>(B)</enum><text display-inline="yes-display-inline">details of other items not required by paragraph (1). </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC8AAFC660309437B9DA9EE98090E0921"><enum>(3)</enum><header>Indemnification provisions</header><text>Nothing in this section shall be construed to prohibit any covered entity from entering into a contract with any other covered entity that contains an indemnification provision with respect to price or fee information disclosed, exchanged, or shared between the covered entities that are parties to the contract.</text></paragraph></subsection><subsection id="H888A02E5C21945D7B77894FDEDD2D7BA"><enum>(b)</enum><header>Enforcement</header><paragraph commented="no" display-inline="no-display-inline" id="HBADC167F937042788B15EC6CA1D21CAF"><enum>(1)</enum><header display-inline="yes-display-inline">Enforcement by the Commission</header><subparagraph id="HB20C7F36376543BDA8A42090EA4F460D"><enum>(A)</enum><header>Unfair or deceptive acts or practices</header><text>A violation of subsection (a) shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under section 18(a)(1)(B) of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/57a">15 U.S.C. 57a(a)(1)(B)</external-xref>).</text></subparagraph><subparagraph id="H288593226CAD4AD889EC4513E8B26D42"><enum>(B)</enum><header>Powers of the Commission</header><clause id="HC7E39C7196C34A00B495563D9FDA0BC4"><enum>(i)</enum><header>In general</header><text>The Commission shall enforce this section in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/41">15 U.S.C. 41 et seq.</external-xref>) were incorporated into and made a part of this Act. </text></clause><clause commented="no" display-inline="no-display-inline" id="H79E28861F00F4C95BF25872FAE4DAF87"><enum>(ii)</enum><header>Privileges and immunities</header><text display-inline="yes-display-inline">Any person who violates this section shall be subject to the penalties and entitled to the privileges and immunities provided in the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/41">15 U.S.C. 41 et seq.</external-xref>).</text></clause><clause commented="no" display-inline="no-display-inline" id="HB3B0C389AD2A40FCBC00BC66389DDEFB"><enum>(iii)</enum><header>Authority preserved</header><text>Nothing in this section shall be construed to limit the authority of the Commission under any other provision of law.</text></clause></subparagraph></paragraph><paragraph id="HA2B3B6C0AF31413F956E2E3D488268A5"><enum>(2)</enum><header>Enforcement by states</header><subparagraph id="HD5B2F6D72E924E67BEDDA42F85820AE7"><enum>(A)</enum><header>In general</header><text>If the attorney general of a State has reason to believe that an interest of the residents of the State has been or is being threatened or adversely affected by a practice that violates subsection (a), the attorney general of the State may, as parens patriae, bring a civil action on behalf of the residents of the State in an appropriate district court of the United States to obtain appropriate relief. </text></subparagraph><subparagraph id="H008BA47F371B41399BFE502A0DEB7483"><enum>(B)</enum><header>Rights of the Commission</header><clause id="H4609F5D7DC8647BD8C006F9916A968E6"><enum>(i)</enum><header>Notice to the Commission</header><subclause id="HCC0B248DB7AA47259912DDA4FB73A2B1"><enum>(I)</enum><header>In general</header><text>Except as provided in subclause (III), the attorney general of a State, before initiating a civil action under subparagraph (A) shall notify the Commission in writing that the attorney general intends to bring such civil action.</text></subclause><subclause id="H225688AE151647B6B5C360739EC4A3FE"><enum>(II)</enum><header>Contents</header><text>The notification required by subclause (I) shall include a copy of the complaint to be filed to initiate the civil action.</text></subclause><subclause id="HEB06A9777F404AD389F9E2B801ABB2B4"><enum>(III)</enum><header>Exception</header><text>If it is not feasible for the attorney general of a State to provide the notification required by subclause (I) before initiating a civil action under subparagraph (A), the attorney general shall notify the Commission immediately upon instituting the civil action.</text></subclause></clause><clause id="HF220CE0808914FAAA62E0AFF029D5379"><enum>(ii)</enum><header>Intervention by the Commission</header><text>The Commission may—</text><subclause id="HA5B7EF4B9B0146628FC7E2C7ADAF6BB4"><enum>(I)</enum><text>intervene in any civil action brought by the attorney general of a State under subparagraph (A); and</text></subclause><subclause id="HB1118E83B73649BCB9381935F7AC5669"><enum>(II)</enum><text>upon intervening—</text><item id="H5852AF5DF752488FA29E723C94A92A07"><enum>(aa)</enum><text>be heard on all matters arising in the civil action; and</text></item><item id="HD40FF80F95B94E1E94867C8B880210F8"><enum>(bb)</enum><text>file petitions for appeal.</text></item></subclause></clause></subparagraph><subparagraph id="H5534D25C741448A298533A7B96F8D9DF"><enum>(C)</enum><header>Investigatory powers</header><text>Nothing in this paragraph may be construed to prevent the attorney general of a State from exercising the powers conferred on the attorney general by the laws of the State to conduct investigations, to administer oaths or affirmations, or to compel the attendance of witnesses or the production of documentary or other evidence.</text></subparagraph><subparagraph id="HCF63029A66D94A68A997F6B12C79AB5E"><enum>(D)</enum><header>Action by the Commission</header><text>Whenever a civil action has been instituted by or on behalf of the Commission for violation of subsection (a), no attorney general of a State may, during the pendency of that action, institute an action under subparagraph (A) against any defendant named in the complaint in that action for a violation of subsection (a) alleged in such complaint.</text></subparagraph><subparagraph id="HC616798C7C43458DBA2D137B03AA7948"><enum>(E)</enum><header>Venue; service of process</header><clause id="H051550921470430E942B1D1FB07AEFFA"><enum>(i)</enum><header>Venue</header><text>Any action brought under subparagraph (A) may be brought in—</text><subclause id="H6F425F69661A42ACB8A0494080DE1D30"><enum>(I)</enum><text>the district court of the United States that meets applicable requirements relating to venue under section 1391 of title 28, United States Code; or</text></subclause><subclause id="H959674BFF1B94E05999BAB87FE2D38E0"><enum>(II)</enum><text>another court of competent jurisdiction.</text></subclause></clause><clause id="H9FBC70BA85734FAB90352142EA6CD82A" commented="no"><enum>(ii)</enum><header>Service of process</header><text>In an action brought under subparagraph (A), process may be served in any district in which—</text><subclause id="H6FFD56F7AD164B35B1160E15C236EBDB" commented="no"><enum>(I)</enum><text>the defendant is an inhabitant, may be found, or transacts business; or</text></subclause><subclause id="H3E603329F4684E70BA5798A7C86CBC66" commented="no"><enum>(II)</enum><text>venue is proper under section 1391 of title 28, United States Code.</text></subclause></clause></subparagraph><subparagraph id="H1B8A7BE218104C8782A18BFF2B59A2DA"><enum>(F)</enum><header>Actions by other state officials</header><clause id="H0BECE07438394F5C85E0DB0BC36605C5"><enum>(i)</enum><header>In general</header><text>In addition to civil actions brought by an attorney general under subparagraph (A), any other officer of a State who is authorized by the State to do so may bring a civil action under subparagraph (A), subject to the same requirements and limitations that apply under this paragraph to civil actions brought by attorneys general.</text></clause><clause id="H51B0061172064F2197778917365FD880" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><header>Savings provision</header><text>Nothing in this paragraph may be construed to prohibit an authorized official of a State from initiating or continuing any proceeding in a court of the State for a violation of any civil or criminal law of the State.</text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1FC076836C4840068B989ECFCE76AB78"><enum>(3)</enum><header>Affirmative defense</header><text>In any action pursuant to paragraph (1) or (2), an intermediary or third-party online seller may assert an affirmative defense if such intermediary or third-party online seller— </text><subparagraph commented="no" display-inline="no-display-inline" id="HAE9109118705456B862A8655D08177B8"><enum>(A)</enum><text>established procedures to receive up-to-date price information from hotels or short-term rentals, or agents acting on behalf of a hotel or short-term rental;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H45DBD73CFC7D4BA4AE16903D84CF3BDC"><enum>(B)</enum><text display-inline="yes-display-inline">relied in good faith on information provided to the intermediary or third-party online seller by a hotel or short-term rental, or agent acting on behalf of such hotel or short-term rental, and such information was inaccurate at the time it was provided to the intermediary or third-party online seller; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDB2AEC66B7654BEAB377A7CB0D564DC5"><enum>(C)</enum><text>took prompt action to remove or correct any false or inaccurate information about the total services price after receiving notice that such information was false or inaccurate.</text></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H16E50F9560884C8AB3E92473FF7B6C70"><enum>(c)</enum><header>Preemption</header><paragraph commented="no" display-inline="no-display-inline" id="H632DF7F812A04F6A89049204781D2888"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text>A State, or political subdivision of a State, may not maintain, enforce, prescribe, or continue in effect any law, rule, regulation, requirement, standard, or other provision having the force and effect of law of the State, or political subdivision of the State, that prohibits a covered entity from advertising, displaying, marketing, or otherwise offering, or otherwise affects the manner in which a covered entity may advertise, display, market, or otherwise offer, for sale in interstate commerce, including through a direct offering, third-party distribution, or metasearch referral, a price of a reservation for a covered service, and that requires fee disclosure, unless the law requires the total services price to include each service fee, as defined in subsection (d)(8), and in accordance with subsection (a)(1). </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7D9B984766D44B78AC9F396F0CC1364C"><enum>(2)</enum><header>Rule of Construction</header><text display-inline="yes-display-inline">This section may not be construed to—</text><subparagraph commented="no" display-inline="no-display-inline" id="H27BA80B4CCAD43C3BC9E1EF7CCF37BB1"><enum>(A)</enum><text display-inline="yes-display-inline">preempt any law of a State or political subdivision of a State relating to contracts or torts; or </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H745C5DB25FD4472F906F8C09DACA87DB"><enum>(B)</enum><text display-inline="yes-display-inline">preempt any law of a State or political subdivision of a State to the extent that such law relates to an act of fraud, unauthorized access to personal information, or notification of unauthorized access to personal information.</text></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HE96CF9BC8D0B4561B062CD53997A5225"><enum>(d)</enum><header>Definitions</header><text>In this Act:</text><paragraph commented="no" display-inline="no-display-inline" id="HEA97DA08802F4DD0AA11F11F7E9828A3"><enum>(1)</enum><header>Base services price</header><text>The term <term>base services price</term> —</text><subparagraph commented="no" display-inline="no-display-inline" id="H7518A7063B444A0DB8B115BD0B1B0FEA"><enum>(A)</enum><text display-inline="yes-display-inline">means, with respect to the covered services provided by a hotel or short-term rental, the price in order to obtain the covered services of the hotel or short-term rental; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC0A7472A66324075BA411309AB5EBA09"><enum>(B)</enum><text display-inline="yes-display-inline">does not include— </text><clause commented="no" display-inline="no-display-inline" id="HF5264E07EB844BDE9F836BAC385B2455"><enum>(i)</enum><text display-inline="yes-display-inline">any service fee;</text></clause><clause commented="no" display-inline="no-display-inline" id="HBB398490DF1C4069B4B5895BEB5ECD44"><enum>(ii)</enum><text>any taxes or fees imposed by a government or quasi-government entity;</text></clause><clause commented="no" display-inline="no-display-inline" id="H8145EAB8D46C46E39444FBACA632AC98"><enum>(iii)</enum><text>assessment fees of a government-created special district or program; or</text></clause><clause commented="no" display-inline="no-display-inline" id="HB74D9B0CF6B54EBDA25B14298E6A4B6F"><enum>(iv)</enum><text display-inline="yes-display-inline">any charges or fees for an optional product or service associated with the covered services that may be selected by a purchaser of covered services.</text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H575A88B8949446EB8ED3B475ACA3D254"><enum>(2)</enum><header display-inline="yes-display-inline">Commission</header><text display-inline="yes-display-inline">The term <term>Commission</term> means the Federal Trade Commission.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC6F1DAB7972B421182077E3D2A9E6252"><enum>(3)</enum><header>Covered entity</header><text>The term <term>covered entity</term> means a person, partnership, or corporation with respect to whom the Commission has jurisdiction under section 5(a)(2) of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45(a)(2)</external-xref>), including—</text><subparagraph commented="no" display-inline="no-display-inline" id="H7775A360A8AC4228B7330E903821E72D"><enum>(A)</enum><text display-inline="yes-display-inline">a hotel or short-term rental;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6DB59BD1BD5F4811A210435DD9B85B85"><enum>(B)</enum><text display-inline="yes-display-inline">a third-party online seller; or</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5D213DEDFCB14F88A4AA95CC7EB933E0"><enum>(C)</enum><text>an intermediary.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF0BE483DFFFF451FA2F47D1A37A6737C"><enum>(4)</enum><header>Covered services</header><text>The term <term>covered services</term>—</text><subparagraph commented="no" display-inline="no-display-inline" id="H425F8F5B08BD4451ABA2581E8A3F8392"><enum>(A)</enum><text display-inline="yes-display-inline">means the temporary provision of a room, building, or other lodging facility; and </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H62D03B2144CF42E6874E61DF891B033C"><enum>(B)</enum><text display-inline="yes-display-inline">does not include the provision of a meeting room, banquet services, or catering services.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HB6BAD28857144076B0B12F035F694FB1"><enum>(5)</enum><header>Hotel</header><text>The term <term>hotel</term> means an establishment that is—</text><subparagraph commented="no" display-inline="no-display-inline" id="H2493AEFD7DA24FAF91EC21338D51945E"><enum>(A)</enum><text>primarily engaged in providing a covered service to the general public; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2D386AA5663C4B68B032EC82EB8443A4"><enum>(B)</enum><text>promoted, advertised, or marketed in interstate commerce or for which such establishment's services are sold in interstate commerce.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFD4D5AEC81F54C37AA77FFD865FE5AC1"><enum>(6)</enum><header>Intermediary</header><text>The term <term>intermediary</term> means an entity that operates either as a business-to-business platform, consumer-facing platform, or both, that displays, including through direct offerings, third-party distribution, or metasearch referral, a price for covered services or price comparison tools for consumers seeking covered services. </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3760B40EB03B43EA95E9316A65B68F91"><enum>(7)</enum><header>Optional product or service</header><text>The term <term>optional product or service</term> means a product or service that an individual does not need to purchase to use or obtain covered services.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H688A454D14E9400D90645D202DF6028A"><enum>(8)</enum><header>Service fee</header><text>The term <term>service fee</term>—</text><subparagraph commented="no" display-inline="no-display-inline" id="H892E67CB72DE4D3295DA1450DC93AF5F"><enum>(A)</enum><text display-inline="yes-display-inline">means a charge imposed by a covered entity that must be paid in order to obtain covered services; and </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEA81C4C1578F431A8CAC1A2D4D43264C"><enum>(B)</enum><text display-inline="yes-display-inline">does not include— </text><clause commented="no" display-inline="no-display-inline" id="H340BAC66A2A04043AE75CDB0FDE4BF92"><enum>(i)</enum><text display-inline="yes-display-inline">any taxes or fees imposed by a government or quasi-government entity;</text></clause><clause commented="no" display-inline="no-display-inline" id="HBE38E022104548719E56356EE1B33A82"><enum>(ii)</enum><text display-inline="yes-display-inline">any assessment fees of a government-created special district or program; or </text></clause><clause commented="no" display-inline="no-display-inline" id="HE05DB8666A6647FAAC22A116FBF4CD66"><enum>(iii)</enum><text display-inline="yes-display-inline">any charges or fees for an optional product or service associated with the covered services that may be selected by a purchaser of covered services.</text></clause></subparagraph></paragraph><paragraph id="H21D8605E78B8431482DFD57B65383B13"><enum>(9)</enum><header>Short-term rental</header><text>The term <term>short-term rental</term> means a property, including a single-family dwelling or a unit in a condominium, cooperative, or time-share, that provides covered services (either with respect to the entire property or a part of the property) to the general public—</text><subparagraph commented="no" display-inline="no-display-inline" id="HA4E5F3C53C714C21966FC1A190E7A929"><enum>(A)</enum><text display-inline="yes-display-inline">in exchange for a fee;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H858EBF4C7F5940D380F6106A38EDAFC5"><enum>(B)</enum><text>for periods shorter than 30 consecutive days; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H35DCD680FFBB4211BAB8FCC331D00F7C"><enum>(C)</enum><text>is promoted, advertised, or marketed in interstate commerce or for which such property’s services are sold in interstate commerce.</text></subparagraph></paragraph><paragraph id="H552DFB3EBD5543F68BA7C559AF465E56" commented="no" display-inline="no-display-inline"><enum>(10)</enum><header>State</header><text>The term <term>State</term> means each of the 50 States, the District of Columbia, and any territory or possession of the United States.</text></paragraph><paragraph id="H2C9ADD916776473F89EE323CEEEE31B7"><enum>(11)</enum><header>Third-party online seller</header><text>The term <term>third-party online seller</term> means any person other than a hotel or short-term rental that sells covered services or offers for sale covered services with respect to a hotel or short-term rental in a transaction facilitated on the internet. </text></paragraph><paragraph id="H1B0A3250ECFB4799B694938DE6342424"><enum>(12)</enum><header>Total services price</header><text>The term <term>total services</term>—</text><subparagraph commented="no" display-inline="no-display-inline" id="H71C85B52ED8448ED987F1888DAA27773"><enum>(A)</enum><text display-inline="yes-display-inline">means, with respect to covered services, the total cost of the covered services, including the base services price and any service fees; and </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD8391EB9AD014D37B39C8F33E6C880D1"><enum>(B)</enum><text display-inline="yes-display-inline">does not include— </text><clause commented="no" display-inline="no-display-inline" id="H08812034BF854EDF903C344B49CEE8F1"><enum>(i)</enum><text display-inline="yes-display-inline">any taxes or fees imposed by a government or quasi-government entity;</text></clause><clause commented="no" display-inline="no-display-inline" id="H5215BB5F1ED34FD48E09DE3B0B6ACD70"><enum>(ii)</enum><text display-inline="yes-display-inline">any assessment fees of a government-created special district or program; or</text></clause><clause commented="no" display-inline="no-display-inline" id="HDA543A396A8A4078BB436890BF7A72FD"><enum>(iii)</enum><text display-inline="yes-display-inline">any charges or fees for an optional product or service associated with the covered services that may be selected by a purchaser of covered services.</text></clause></subparagraph></paragraph></subsection><subsection id="HD7FB4F11A7BC46DF951F0111FA085631"><enum>(e)</enum><header>Effective date</header><text display-inline="yes-display-inline">The prohibition under subsection (a) shall take effect 450 days after the date of the enactment of this Act and shall apply to advertisements, displays, marketing, and offers of covered services of a covered entity made on or after such date.</text></subsection></section></title><title id="H0A02752352904DB8A0FD92BD860D6912" commented="no"><enum>XIV</enum><header>Transparency In Charges for Key Events Ticketing</header><section id="H9229F797C5184BEA85377A5B20D56510" commented="no"><enum>1401.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Transparency In Charges for Key Events Ticketing Act</quote> or the <quote>TICKET Act</quote>.</text></section><section id="H0A2DA72108364ED491CBB95F2EB72CC4" commented="no"><enum>1402.</enum><header>All inclusive ticket price disclosure</header><text display-inline="no-display-inline">Beginning 180 days after the date of the enactment of this Act, it shall be unlawful for a ticket issuer, secondary market ticket issuer, or secondary market ticket exchange to offer for sale an event ticket unless the ticket issuer, secondary market ticket issuer, or secondary market ticket exchange—</text><paragraph id="H3F505D67E39142468529AB33B19D07D4" commented="no"><enum>(1)</enum><text>clearly and conspicuously displays the total event ticket price, if a price is displayed, in any advertisement, marketing, or price list wherever the ticket is offered for sale;</text></paragraph><paragraph id="HD7FF15F4CA0E4A19A3C7E625B7738573" commented="no"><enum>(2)</enum><text>clearly and conspicuously discloses to any individual who seeks to purchase an event ticket the total event ticket price at the time the ticket is first displayed to the individual and anytime thereafter throughout the ticket purchasing process; and</text></paragraph><paragraph id="H82F95748A698473B97D89CE35C5F6085" commented="no"><enum>(3)</enum><text>provides an itemized list of the base event ticket price and each event ticket fee prior to the completion of the ticket purchasing process.</text></paragraph></section><section id="H09729C6272404086AA5312AE4E7CC733" commented="no"><enum>1403.</enum><header>Speculative ticketing ban</header><subsection id="HA4AF26D8D0C042B19A6852C9BA2EFA80" commented="no"><enum>(a)</enum><header>Prohibition</header><text>Beginning 180 days after the date of the enactment of this Act, a ticket issuer, secondary market ticket issuer, or secondary market ticket exchange that does not have actual or constructive possession of an event ticket shall not sell, offer for sale, or advertise for sale such event ticket.</text></subsection><subsection id="H0F3BD9A114D343229210229950DE7817" commented="no"><enum>(b)</enum><header>Services permitted</header><text>Notwithstanding subsection (a), a secondary market ticket issuer or secondary market ticket exchange may sell, offer for sale, or advertise for sale a service to an individual to obtain an event ticket on behalf of such individual if the secondary market ticket issuer or secondary market ticket exchange complies with the following:</text><paragraph id="H3182FE9FDDEB4151A58083503365D146" commented="no"><enum>(1)</enum><text>Does not market or list the service as an event ticket.</text></paragraph><paragraph id="H88688055DF8F4416BDA510F7D3469CA0" commented="no"><enum>(2)</enum><text>Maintains a clear, distinct, and easily discernible separation between the service and event tickets that persists throughout the entire service selection and purchasing process.</text></paragraph><paragraph id="H83613151E52841538B26F911337F9F27" commented="no"><enum>(3)</enum><text>Clearly and conspicuously discloses before selection of the service that the service is not an event ticket and that the purchase of the service does not guarantee an event ticket.</text></paragraph></subsection></section><section id="HA37A8F94855347CE9E14A4726EFEDCA6" commented="no"><enum>1404.</enum><header>Disclosures</header><text display-inline="no-display-inline">A ticket issuer, secondary market ticket issuer, or secondary market ticket exchange—</text><paragraph id="H597BB478437A4AEE99DC5307F087D8AE" commented="no"><enum>(1)</enum><text>if offering an event ticket for resale, shall provide a clear and conspicuous statement, before a consumer purchases the event ticket from the ticket issuer, secondary market ticket issuer, or secondary market ticket exchange, that the issuer or exchange is engaged in the secondary sale of event tickets; and</text></paragraph><paragraph id="H9C542A1BB6534DB7BB3C8599EA91877D" commented="no"><enum>(2)</enum><text>shall not state that the ticket issuer, secondary market ticket issuer, or secondary market ticket exchange is affiliated with or endorsed by a venue, team, or artist, as applicable, including by using words like <quote>official</quote> in promotional materials, social media promotions, or paid advertising, unless a partnership agreement has been executed or the issuer or exchange has the express written consent of the venue, team, or artist, as applicable.</text></paragraph></section><section id="HEDBFBA7C57974726A41D1F1DA5BE1F66" commented="no"><enum>1405.</enum><header>Refund requirements</header><subsection id="H9E38CE7884E646C6A59CEDEB4867CD5D" commented="no"><enum>(a)</enum><header>Cancellation</header><text>Beginning 180 days after the date of the enactment of this Act, if an event is canceled or postponed (except for a case in which an event is canceled or postponed due to a cause beyond the reasonable control of the issuer, including a natural disaster, civil disturbance, or otherwise unforeseeable impediment), a ticket issuer, secondary market ticket issuer, or secondary market ticket exchange shall provide the purchaser of an event ticket from the issuer or exchange for the canceled or postponed event, at a minimum—</text><paragraph id="HFCEE16A9FBC946B1B84EF37798CF4DC3" commented="no"><enum>(1)</enum><text>if the event is cancelled, a full refund for the total event ticket price;</text></paragraph><paragraph id="HE9A90CBC744B44529F2577255E20E844" commented="no"><enum>(2)</enum><text>subject to availability, if the event is postponed for not more than 6 months and the original event ticket is no longer valid for entry to the rescheduled event, a replacement event ticket for the rescheduled event in the same or a comparable location once the event has been rescheduled; or</text></paragraph><paragraph id="HAB686931C8D649DEAA46A610F99FFDE8" commented="no"><enum>(3)</enum><text display-inline="yes-display-inline">if the event is postponed for more than 6 months, at the option of the purchaser—</text><subparagraph id="H8EBC6C9673A34FF788FAFF2E7EFCCAE5" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">a full refund for the total event ticket price; or</text></subparagraph><subparagraph id="HADF40A21F61340CC8CF0D81C28B702F8" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">if the original event ticket is no longer valid for entry to the rescheduled event, a replacement event ticket for the rescheduled event in the same or a comparable location once the event has been rescheduled.</text></subparagraph></paragraph></subsection><subsection id="HFF099F24B589496D801918C4D5048CDC" commented="no"><enum>(b)</enum><header>Disclosure of guarantee and refund policy required</header><text>Beginning 180 days after the date of the enactment of this Act, a ticket issuer, secondary market ticket issuer, or secondary market ticket exchange shall disclose clearly and conspicuously to a purchaser before the completion of an event ticket sale the guarantee or refund policy of such ticket issuer, secondary market ticket issuer, or secondary market ticket exchange, including under what circumstances any refund issued will include a refund of any event ticket fee.</text></subsection><subsection id="H5E0091CCBBBD4DB796A3125BB64380BC" commented="no"><enum>(c)</enum><header>Disclosure of how To obtain a refund required</header><text>Beginning 180 days after the date of the enactment of this Act, a ticket issuer, secondary market ticket issuer, or secondary market ticket exchange shall provide a clear and conspicuous explanation of how to obtain a refund of the total event ticket price.</text></subsection></section><section id="H58992CD8F3224378863A2D8195774A47" commented="no"><enum>1406.</enum><header>Report by the Federal Trade Commission on BOTS Act of 2016 enforcement</header><text display-inline="no-display-inline">Not later than 6 months after the date of the enactment of this Act, the Commission shall submit to Congress a report on enforcement of the Better Online Ticket Sales Act of 2016 (<external-xref legal-doc="public-law" parsable-cite="pl/114/274">Public Law 114–274</external-xref>; <external-xref legal-doc="usc" parsable-cite="usc/15/45c">15 U.S.C. 45c</external-xref>), including any enforcement action taken, challenges with enforcement and coordination with State Attorneys General, and recommendations on how to improve enforcement and industry compliance.</text></section><section id="H11031E49FF18434AB83E797A33AC5616" commented="no"><enum>1407.</enum><header>Enforcement</header><subsection id="H23600F81B20741208B465B0EBB3D109E" commented="no"><enum>(a)</enum><header>Unfair or deceptive act or practice</header><text>A violation of this title shall be treated as a violation of a rule defining an unfair or deceptive act or practice under section 18(a)(1)(B) of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/57a">15 U.S.C. 57a(a)(1)(B)</external-xref>).</text></subsection><subsection id="HE3028D5D29444EC984EFDCCBDEF19993" commented="no"><enum>(b)</enum><header>Powers of commission</header><paragraph id="HCD9E8C80FA994FB1AE965AFADFE8DD76" commented="no"><enum>(1)</enum><header>In general</header><text>The Commission shall enforce this title in the same manner, by the same means, and with the same jurisdiction, powers, and duties as though all applicable terms and provisions of the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/41">15 U.S.C. 41 et seq.</external-xref>) were incorporated into and made a part of this title.</text></paragraph><paragraph id="H05B8A9A8D01D4D999A451DC6A7784E02" commented="no"><enum>(2)</enum><header>Privileges and immunities</header><text>Any person who violates this title shall be subject to the penalties and entitled to the privileges and immunities provided in the Federal Trade Commission Act (<external-xref legal-doc="usc" parsable-cite="usc/15/41">15 U.S.C. 41 et seq.</external-xref>).</text></paragraph><paragraph id="HBC95496F49654B8AA8DC65624ACF8395" commented="no"><enum>(3)</enum><header>Authority preserved</header><text>Nothing in this title shall be construed to limit the authority of the Commission under any other provision of law.</text></paragraph></subsection></section><section id="HA4615AF04BE54CB6BDCDE25C751933C8" commented="no"><enum>1408.</enum><header>Definitions</header><text display-inline="no-display-inline">In this title:</text><paragraph id="HBE925E8574D440698BDE07FEFE435CA3" commented="no"><enum>(1)</enum><header>Artist</header><text>The term <term>artist</term> means any performer, musician, comedian, producer, ensemble or production entity of a theatrical production, sports team owner, or similar person.</text></paragraph><paragraph id="H7E131DA170A343EFA8DC098E1F2240B2" commented="no"><enum>(2)</enum><header>Base event ticket price</header><text>The term <term>base event ticket price</term> means, with respect to an event ticket, the price of the event ticket excluding the cost of any event ticket fees.</text></paragraph><paragraph id="HF06EFF47FA4A4CC38055938CCC49F7C0" commented="no"><enum>(3)</enum><header>Commission</header><text>The term <term>Commission</term> means the Federal Trade Commission.</text></paragraph><paragraph id="H86866935F58645B58B006BC2998C9CA5" commented="no"><enum>(4)</enum><header>Event</header><text>The term <term>event</term> means any live concert, theatrical performance, sporting event, show, or similarly scheduled live activity, that is—</text><subparagraph id="H51CB6AA4B1944496BB6422ADFB86C4BB" commented="no"><enum>(A)</enum><text>taking place in a venue with a seating or attendance capacity exceeding 200 persons;</text></subparagraph><subparagraph id="HDFE9510895834F649615A9AFD419FC96" commented="no"><enum>(B)</enum><text>open to the general public; and</text></subparagraph><subparagraph id="HC6F7B5A6B1AB41C6B3AB2CE61B6EACC4" commented="no"><enum>(C)</enum><text>promoted, advertised, or marketed in interstate commerce, or for which event tickets are generally sold or distributed in interstate commerce.</text></subparagraph></paragraph><paragraph id="HBC1E8AFF4B904DDCB6076E8C7D00E7AD" commented="no"><enum>(5)</enum><header>Event ticket; ticket issuer</header><text display-inline="yes-display-inline">The terms <term>event ticket</term> and <term>ticket issuer</term> have the meaning given those terms in section 3 of the Better Online Ticket Sales Act of 2016 (<external-xref legal-doc="usc" parsable-cite="usc/15/45c">15 U.S.C. 45c</external-xref> note).</text></paragraph><paragraph id="H9256C728A538434A8D2DDF9ACF65122C" commented="no"><enum>(6)</enum><header>Event ticket fee</header><text>The term <term>event ticket fee</term>—</text><subparagraph id="H004F6C9FD87B4D749D848D4ECAC0DDF1" commented="no"><enum>(A)</enum><text>means a charge for an event ticket that must be paid in addition to the base event ticket price in order to obtain an event ticket from a ticket issuer, secondary market ticket issuer, or secondary market ticket exchange, including any service fee, charge and order processing fee, delivery fee, facility charge fee, tax, and any other charge; and</text></subparagraph><subparagraph id="HF94EE6DD11004F16B9530C4C6E10493D" commented="no"><enum>(B)</enum><text>does not include any charge or fee for an optional product or service associated with the event that may be selected by a purchaser of an event ticket.</text></subparagraph></paragraph><paragraph id="H0DDD4F45E92F40D294EDBA1A62EDCD9C" commented="no"><enum>(7)</enum><header>Optional product or service</header><text>The term <term>optional product or service</term> means a product or service that an individual does not need to purchase to use or take possession of an event ticket.</text></paragraph><paragraph id="H7D59627FA6EB452C80A075F701952802" commented="no"><enum>(8)</enum><header>Resale; secondary sale</header><text>The terms <term>resale</term> and <term>secondary sale</term> mean any sale of an event ticket that occurs after the initial sale of the event ticket by a ticket issuer.</text></paragraph><paragraph id="HB7E624BDBC7D456495DA7EE96E3AA027" commented="no"><enum>(9)</enum><header>Secondary market ticket exchange</header><text>The term <term>secondary market ticket exchange</term> means any person that in the regular course of trade or business of that person operates a platform or exchange for advertising, listing, or selling resale tickets, on behalf of itself, vendors, or a secondary market ticket issuer.</text></paragraph><paragraph id="H25FB268F93294600B607A4E255FC3911" commented="no"><enum>(10)</enum><header>Secondary market ticket issuer</header><text>The term <term>secondary market ticket issuer</term> means any person, including a ticket issuer, that resells or makes a secondary sale of an event ticket to the general public in the regular course of the trade or business of the person.</text></paragraph><paragraph id="HF7C2380B3C7B410A96812877759104C8" commented="no"><enum>(11)</enum><header>Total event ticket price</header><text>The term <term>total event ticket price</term> means, with respect to an event ticket, the total cost of the event ticket, including the base event ticket price and any event ticket fee.</text></paragraph><paragraph id="H9BC7B514904E4D2EBAE19C8A24172316" commented="no"><enum>(12)</enum><header>Venue</header><text>The term <term>venue</term> means a physical space at which an event takes place.</text></paragraph></section></title><title id="H868B5652787C4FC29C2CDE44AF171CB6" style="OLC" commented="no"><enum>XV</enum><header>ROUTERS Act</header><section id="HFA284352225241CEB3F0EE1758F29AE4" commented="no"><enum>1501.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Removing Our Unsecure Technologies to Ensure Reliability and Security Act</quote> or the <quote>ROUTERS Act</quote>.</text></section><section id="H932554FC4C3849F98D49F3061E8329AE" commented="no"><enum>1502.</enum><header>Study of national security risks posed by certain routers and modems</header><subsection id="HA8FF4FCEDBB64618AC7CD6F6883F9B22" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall conduct a study of the national security risks posed by consumer routers, modems, and devices that combine a modem and router that are designed, developed, manufactured, or supplied by persons owned by, controlled by, or subject to the influence of a covered country.</text></subsection><subsection id="HD10D921B869246FEBDA714956738D51D" commented="no"><enum>(b)</enum><header>Report to Congress</header><text display-inline="yes-display-inline">Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Commerce, Science, and Transportation of the Senate a report on the results of the study conducted under subsection (a).</text></subsection><subsection id="H3D2C2AB0E617410E99337F6391BD09FD" commented="no"><enum>(c)</enum><header>Definitions</header><text>In this section:</text><paragraph id="H1F0065E6FF59483E98E6BF0162859DF6" commented="no"><enum>(1)</enum><header>Covered country</header><text display-inline="yes-display-inline">The term <term>covered country</term> means a country specified in section 4872(f)(2) of title 10, United States Code.</text></paragraph><paragraph id="H0DD3F071676245A1922DE55A43BB22D5" commented="no" display-inline="no-display-inline"><enum>(2)</enum><header>Secretary</header><text display-inline="yes-display-inline">The term <term>Secretary</term> means the Secretary of Commerce, in consultation with the Assistant Secretary of Commerce for Communications and Information.</text></paragraph></subsection></section></title><title id="HD82ACD345A0B4565834B67FDFA4B7F99"><enum>XVI</enum><header>NTIA Reauthorization</header><section id="H5CD66FCB877D48A8A09CF9BEB3F843D7" section-type="subsequent-section"><enum>1601.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>National Telecommunications and Information Administration Reauthorization Act</quote> or the <quote>NTIA Reauthorization Act</quote>.</text></section><section id="H84EFF7EA19154DCEBD4CA4A63DB2E36D"><enum>1602.</enum><header>Definitions</header><text display-inline="no-display-inline">In this title:</text><paragraph id="H386909CB9A9D4C5981DCCA095DDEBBD0"><enum>(1)</enum><header>Commission</header><text>The term <term>Commission</term> means the Federal Communications Commission.</text></paragraph><paragraph id="H39F0E32A79694069BEB891AA0ED54E76"><enum>(2)</enum><header>NTIA</header><text>The term <term>NTIA</term> means the National Telecommunications and Information Administration.</text></paragraph><paragraph id="HE2214345344B435AA2922227B074D54C"><enum>(3)</enum><header>Under Secretary</header><text>The term <term>Under Secretary</term> means the Under Secretary of Commerce for Communications and Information. </text></paragraph></section><subtitle id="H04486902C4B14B5E8C951E6334EC7478"><enum>A</enum><header>Reauthorization</header><section id="H8101430297124E2F804CC0D1ED1A8757"><enum>1611.</enum><header>Reauthorization of the National Telecommunications and Information Administration Organization Act</header><subsection id="H833C677EFE1D4FBD8D6DF01D3504FBB5"><enum>(a)</enum><header>Authorization of appropriations</header><text>Section 151 of the National Telecommunications and Information Administration Organization Act is amended by striking <quote>$17,600,000 for fiscal year 1992 and $17,900,000 for fiscal year 1993</quote> and inserting <quote>$57,000,000 for fiscal year 2025 and $57,000,000 for fiscal year 2026</quote>.</text></subsection><subsection id="H28F608D8EE204511874D8986AA02B94D"><enum>(b)</enum><header>Under secretary of commerce for communications and information</header><paragraph id="HF8E05F7628AF4EF7BF7EDAD96E3F0311"><enum>(1)</enum><header>Under Secretary; Deputy Under Secretary</header><subparagraph id="H33F4573CE7DC4667BD40DC8FF62C9CC3"><enum>(A)</enum><header>Under Secretary</header><text>The National Telecommunications and Information Administration Organization Act (<external-xref legal-doc="usc" parsable-cite="usc/47/901">47 U.S.C. 901 et seq.</external-xref>) is amended by striking <quote>Assistant Secretary</quote> each place it appears and inserting <quote>Under Secretary</quote>.</text></subparagraph><subparagraph id="H5C0F3C7481934BC7899EDE7BF182C267"><enum>(B)</enum><header>Deputy under secretary</header><text>Section 103(a) of the National Telecommunications and Information Administration Organization Act (<external-xref legal-doc="usc" parsable-cite="usc/47/902">47 U.S.C. 902(a)</external-xref>), as amended by this section, is amended by adding at the end the following:</text><quoted-block id="HBB9C504E245B4D078404E9C000703E95" style="OLC"><paragraph id="H443F994001EE4A54BC07D7645FAE68CB"><enum>(3)</enum><header>Deputy under secretary</header><text>The Deputy Under Secretary of Commerce for Communications and Information shall—</text><subparagraph id="H972D2CA566114C6E8CBD374646695E78"><enum>(A)</enum><text>be the principal policy advisor of the Under Secretary;</text></subparagraph><subparagraph id="H466DBB9CF4D44D54A1644F4E37C1DA37"><enum>(B)</enum><text>perform such other functions as the Under Secretary shall from time to time assign or delegate; and</text></subparagraph><subparagraph id="H030EF8115AA2496F9550E6FBD6C9AC4D"><enum>(C)</enum><text>act as Under Secretary during the absence or disability of the Under Secretary or in the event of a vacancy in the office of the Under Secretary.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H198067A5C6AB4F7FB81111C398D06656"><enum>(2)</enum><header>Continuation of civil actions</header><text display-inline="yes-display-inline">This subsection, and the amendments made by this subsection, shall not abate any civil action commenced by or against the Assistant Secretary of Commerce for Communications and Information before the date of the enactment of this Act, except that the Under Secretary shall be substituted as a party to the action on and after such date.</text></paragraph><paragraph id="HD86CAAB501CE492CAA455827705EAC24"><enum>(3)</enum><header>Continuation in office</header><text display-inline="yes-display-inline">The individual serving as the Assistant Secretary of Commerce for Communications and Information and the individual serving as the Deputy Assistant Secretary of Commerce for Communications and Information on the day before the date of the enactment of this Act may serve as the Under Secretary and the Deputy Under Secretary of Commerce for Communications and Information, respectively, on and after that date without the need for renomination or reappointment.</text></paragraph><paragraph id="H91FA1DED3AEB4BA5BCBBE804553658A4"><enum>(4)</enum><header>References</header><text>Any reference in a law, regulation, document, paper, or other record of the United States to the Assistant Secretary of Commerce for Communications and Information shall, on and after the date of the enactment of this Act, be deemed to be a reference to the Under Secretary.</text></paragraph><paragraph id="H158B65CE8770402EB9D741E815D90B5F" commented="no"><enum>(5)</enum><header>Executive schedule</header><subparagraph id="HDEBE6D07F7964D9FA7F68F67767116AD" commented="no"><enum>(A)</enum><header>In general</header><text>Subchapter II of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/53">chapter 53</external-xref> of title 5, United States Code, is amended—</text><clause id="H4A3F271CD15A4796AD179B69F4C9BA59" commented="no"><enum>(i)</enum><text>in section 5314, by adding at the end the following:</text><quoted-block style="USC" id="H94E8A29FB9604A7CB6D552A3A70FFB82" display-inline="no-display-inline"><paragraph id="HB52FBCA7ECC04AF28FA81E0064B04CA2" commented="no"><enum/><text display-inline="yes-display-inline">Under Secretary of Commerce for Communications and Information.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause><clause id="HBA0F06C1A9CD44528885B1F7C8663B9D" commented="no"><enum>(ii)</enum><text>in section 5315, in the item relating to the Assistant Secretaries of Commerce, by striking <quote>(11)</quote> and inserting <quote>(10)</quote>.</text></clause></subparagraph><subparagraph id="HB82CC5CC92A847B691BCE68BFD6C6C91" commented="no"><enum>(B)</enum><header>Effective date</header><text>The amendment made by subparagraph (A) (establishing the annual rate of the basic pay of the Under Secretary) shall take effect on the first day of the first pay period beginning after the date of the enactment of this Act.</text></subparagraph></paragraph></subsection><subsection id="H434B39060E074A0F838B9E11281ACCC4" commented="no"><enum>(c)</enum><header>Authorities and responsibilities</header><paragraph id="HD30AAD56279B4D2DB307E21787C9E2F4" commented="no"><enum>(1)</enum><header>Coordination of executive branch views on matters before the federal communications commission</header><text>Section 105(a)(1) of the National Telecommunications and Information Administration Organization Act (<external-xref legal-doc="usc" parsable-cite="usc/47/904">47 U.S.C. 904(a)(1)</external-xref>) is amended—</text><subparagraph id="H31DCB00FB4854F828A6264C444536D6C" commented="no"><enum>(A)</enum><text>by striking <quote>to ensure that the conduct</quote> and inserting the following: </text><quoted-block style="OLC" id="H9ACC279CE3DF4C49837437163B964362" display-inline="yes-display-inline"><text>to ensure that—</text><subparagraph id="H0A272829EE81492996A5640E4EE84838" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">the conduct</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="HCD79A68704BD4D039C35289A4C57E9BC" commented="no"><enum>(B)</enum><text>in subparagraph (A), as so designated, by striking the period at the end and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph id="H96F315BB9D2547DAB76EC6B5DDA4BFE7" commented="no"><enum>(C)</enum><text>by adding at the end the following:</text><quoted-block id="HF1AD06F01F7F4EF6816090AF7C7A9DFB" style="OLC"><subparagraph id="H6DB1460EF4054BC78AA67CD2AD842504" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">the views of the executive branch on matters presented to the Commission are, consistent with section 103(b)(2)(J)—</text><clause id="H657FE53C62D04FD2B64B6D0B4832BD7A"><enum>(i)</enum><text>appropriately coordinated; and</text></clause><clause id="HB710C4A57EB6469B928E4DB647DC275E"><enum>(ii)</enum><text>reflective of executive branch policy.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="HE0A385FB142F4599BE9DF918262680E3" commented="no"><enum>(2)</enum><header>Assigned functions</header><text>Section 103(b)(2) of the National Telecommunications and Information Administration Organization Act (<external-xref legal-doc="usc" parsable-cite="usc/47/902">47 U.S.C. 902(b)(2)</external-xref>) is amended—</text><subparagraph id="H9CCDBD3B646A4F919474C562FE3C4AD9" commented="no"><enum>(A)</enum><text>in the matter preceding subparagraph (A), by inserting <quote>, some of which were</quote> before <quote>transferred to the Secretary</quote>; and</text></subparagraph><subparagraph id="H393C29B7BF3E49508025A5F26BE44CF3" commented="no"><enum>(B)</enum><text>in subparagraph (M), by inserting <quote>, publish reports,</quote> after <quote>studies</quote>.</text></subparagraph></paragraph><paragraph id="H9D946ECAA49C42CCA894852F3A7C0987"><enum>(3)</enum><header>Rule of construction</header><text display-inline="yes-display-inline">Nothing in the amendments made by paragraphs (1) and (2) may be construed to expand or contract the authority of the Commission.</text></paragraph></subsection><subsection id="H0F8B226E5A7244898E80ADB5853F3A8C"><enum>(d)</enum><header>Technical and conforming amendments</header><paragraph id="H3DFE3351F5D341A99E436069D6E55517"><enum>(1)</enum><header>Public Telecommunications Financing Act of 1978</header><text>Section 106(c) of the Public Telecommunications Financing Act of 1978 (<external-xref legal-doc="usc" parsable-cite="usc/5/5316">5 U.S.C. 5316</external-xref> note; <external-xref legal-doc="public-law" parsable-cite="pl/95/567">Public Law 95–567</external-xref>) is amended by striking <quote>The position of Deputy Assistant Secretary of Commerce for Communications and Information, established in Department of Commerce Organization Order Numbered 10–10 (effective March 26, 1978),</quote> and inserting <quote>The position of Deputy Under Secretary of Commerce for Communications and Information, established under section 103(a) of the National Telecommunications and Information Administration Organization Act (<external-xref legal-doc="usc" parsable-cite="usc/47/902">47 U.S.C. 902(a)</external-xref>),</quote>.</text></paragraph><paragraph id="H48A1EDEEA3C0492EA603AED366D09DCC"><enum>(2)</enum><header>Communications act of 1934</header><text>Section 344(d)(2) of the Communications Act of 1934 (<external-xref legal-doc="usc" parsable-cite="usc/47/344">47 U.S.C. 344(d)(2)</external-xref>) is amended by striking <quote>Assistant Secretary</quote> and inserting <quote>Under Secretary</quote>.</text></paragraph><paragraph id="H37F0A8028630485EB602C6DEFCDAAFEE"><enum>(3)</enum><header>Homeland security act of 2002</header><text>Section 1805(d)(2) of the Homeland Security Act of 2002 (<external-xref legal-doc="usc" parsable-cite="usc/6/575">6 U.S.C. 575(d)(2)</external-xref>) is amended by striking <quote>Assistant Secretary for Communications and Information of the Department of Commerce</quote> and inserting <quote>Under Secretary of Commerce for Communications and Information</quote>.</text></paragraph><paragraph id="H32246744F51F4BAEA8A9E5535DC0C725"><enum>(4)</enum><header>Agriculture improvement act of 2018</header><text>Section 6212 of the Agriculture Improvement Act of 2018 (<external-xref legal-doc="usc" parsable-cite="usc/7/950bb-6">7 U.S.C. 950bb–6</external-xref>) is amended—</text><subparagraph id="HD5524EC8ADAD4375ADDDA6A7B5DF2619"><enum>(A)</enum><text>in subsection (d)(1), in the heading, by striking <quote><header-in-text level="paragraph" style="OLC">Assistant secretary</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Under secretary</header-in-text></quote>; and</text></subparagraph><subparagraph id="HE62741AE6FAF469A9E3CA1740DFF3F7C"><enum>(B)</enum><text>by striking <quote>Assistant Secretary</quote> each place the term appears and inserting <quote>Under Secretary</quote>.</text></subparagraph></paragraph><paragraph id="H7BAB4DDF53314A3CA8B44DB4406A9891"><enum>(5)</enum><header>Title 17, united states code</header><text display-inline="yes-display-inline">Section 1201(a)(1)(C) of title 17, United States Code, is amended by striking <quote>Assistant Secretary for Communications and Information of the Department of Commerce</quote> and inserting <quote>Under Secretary of Commerce for Communications and Information</quote>. </text></paragraph><paragraph id="H2B35960D22D2423AB1608E9C382D3832"><enum>(6)</enum><header>Unlocking consumer choice and wireless competition act</header><text>Section 2(b) of the Unlocking Consumer Choice and Wireless Competition Act (<external-xref legal-doc="usc" parsable-cite="usc/17/1201">17 U.S.C. 1201</external-xref> note; <external-xref legal-doc="public-law" parsable-cite="pl/113/144">Public Law 113–144</external-xref>) is amended by striking <quote>Assistant Secretary for Communications and Information of the Department of Commerce</quote> and inserting <quote>Under Secretary of Commerce for Communications and Information</quote>.</text></paragraph><paragraph id="H64B14C6DDA9F4C128B876ACB61A97426"><enum>(7)</enum><header>Communications satellite act of 1962</header><text>Section 625(a)(1) of the Communications Satellite Act of 1962 (<external-xref legal-doc="usc" parsable-cite="usc/47/763d">47 U.S.C. 763d(a)(1)</external-xref>) is amended, in the matter preceding subparagraph (A), by striking <quote>Assistant Secretary</quote> and inserting <quote>Under Secretary of Commerce</quote>.</text></paragraph><paragraph id="H0DD5A507BFF24B778145F7FB9234C31D" commented="no"><enum>(8)</enum><header>Spectrum pipeline act of 2015</header><text>The Spectrum Pipeline Act of 2015 (<external-xref legal-doc="usc" parsable-cite="usc/47/921">47 U.S.C. 921</external-xref> note; title X of <external-xref legal-doc="public-law" parsable-cite="pl/114/74">Public Law 114–74</external-xref>) is amended—</text><subparagraph id="H107F27EDBFD34451A0347B5A13A11447" commented="no"><enum>(A)</enum><text>in section 1002(1), in the heading, by striking <quote><header-in-text level="paragraph" style="OLC">Assistant secretary</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Under secretary</header-in-text></quote>; and</text></subparagraph><subparagraph id="H2EEEC59E3E5347889C868433F92B9AA0" commented="no"><enum>(B)</enum><text>by striking <quote>Assistant Secretary</quote> each place the term appears and inserting <quote>Under Secretary</quote>.</text></subparagraph></paragraph><paragraph id="H7404A1A507834E61B5E66E8B276A7EFA"><enum>(9)</enum><header>Warning, alert, and response network act</header><text>Section 606 of the Warning, Alert, and Response Network Act (<external-xref legal-doc="usc" parsable-cite="usc/47/1205">47 U.S.C. 1205</external-xref>) is amended—</text><subparagraph id="HAEB85E93A2694373B89425010E967E10" commented="no"><enum>(A)</enum><text>by striking <quote>Assistant Secretary</quote> each place the term appears and inserting <quote>Under Secretary</quote>; and</text></subparagraph><subparagraph id="H96705AC4F1D3425BB2B82DA58672F8B3" commented="no"><enum>(B)</enum><text>in subsection (b), in the first sentence, by striking <quote>for7Communications</quote> and inserting <quote>for Communications</quote>. </text></subparagraph></paragraph><paragraph id="H92FE7393E56148FC89A6320142A80E80" commented="no"><enum>(10)</enum><header>American recovery and reinvestment act of 2009</header><text>Section 6001 of the American Recovery and Reinvestment Act of 2009 (<external-xref legal-doc="usc" parsable-cite="usc/47/1305">47 U.S.C. 1305</external-xref>) is amended by striking <quote>Assistant Secretary</quote> each place the term appears and inserting <quote>Under Secretary</quote>.</text></paragraph><paragraph id="HFB84D2562CF8434593419BEAA66EDF17" commented="no"><enum>(11)</enum><header>Middle class tax relief and job creation act of 2012</header><text>Title VI of the Middle Class Tax Relief and Job Creation Act of 2012 (<external-xref legal-doc="usc" parsable-cite="usc/47/1401">47 U.S.C. 1401 et seq.</external-xref>) is amended—</text><subparagraph id="H23C19C9474E049D69C91BF19D696D334" commented="no"><enum>(A)</enum><text>in section 6001 (<external-xref legal-doc="usc" parsable-cite="usc/47/1401">47 U.S.C. 1401</external-xref>)—</text><clause id="H15CC0340EF404FC0811FCE78B4CEE6BB" commented="no"><enum>(i)</enum><text>by striking paragraph (4);</text></clause><clause id="HF206074B6D5844DAA5F13229D3B91F53" commented="no"><enum>(ii)</enum><text>by redesignating paragraphs (5) through (32) as paragraphs (4) through (31), respectively; and</text></clause><clause id="HB365B815302A4D769534CB09E7C60B70" commented="no"><enum>(iii)</enum><text>by inserting after paragraph (31), as so redesignated, the following:</text><quoted-block id="HC6D28D67D98842EC9286B8DFE87FB88C" style="OLC"><paragraph id="H76D0B6C09D2A4C139F896BC2116F6D02" commented="no"><enum>(32)</enum><header>Under secretary</header><text>The term <term>Under Secretary</term> means the Under Secretary of Commerce for Communications and Information.</text></paragraph><after-quoted-block>; and </after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="H0E1423F2D1CA4229A066ADD77EDD3E60" commented="no"><enum>(B)</enum><text>by striking <quote>Assistant Secretary</quote> each place the term appears and inserting <quote>Under Secretary</quote>.</text></subparagraph></paragraph><paragraph id="H82BD080FD6604162920CCEF240DDBD33"><enum>(12)</enum><header>Ray Baum’s act of 2018</header><text>The RAY BAUM’S Act of 2018 (division P of <external-xref legal-doc="public-law" parsable-cite="pl/115/141">Public Law 115–141</external-xref>; 132 Stat. 348) is amended by striking <quote>Assistant Secretary</quote> each place the term appears and inserting <quote>Under Secretary</quote>.</text></paragraph><paragraph id="H4B7355BAE0744196B9B2724D10A2D6A8"><enum>(13)</enum><header>Secure and trusted communications networks act of 2019</header><text>Section 8 of the Secure and Trusted Communications Networks Act of 2019 (<external-xref legal-doc="usc" parsable-cite="usc/47/1607">47 U.S.C. 1607</external-xref>) is amended—</text><subparagraph id="HFBBA158D3A10444884CB74AAA9B4D9D6"><enum>(A)</enum><text display-inline="yes-display-inline">in subsection (c)(1), in the heading, by striking <quote><header-in-text level="paragraph" style="OLC">Assistant secretary</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Under secretary</header-in-text></quote>; and</text></subparagraph><subparagraph id="H23FB6F1CC9A74DC1B3B1192F4090CB43"><enum>(B)</enum><text>by striking <quote>Assistant Secretary</quote> each place the term appears and inserting <quote>Under Secretary</quote>.</text></subparagraph></paragraph><paragraph id="H49732BDE250D4652A0585A42B591F046"><enum>(14)</enum><header>Title 51, united states code</header><text>Section 50112(3) of title 51, United States Code, is amended, in the matter preceding subparagraph (A), by striking <quote>Assistant Secretary</quote> each place the term appears and inserting <quote>Under Secretary</quote>.</text></paragraph><paragraph id="HD03DD2F62AF449DEB1B728DE58D01DB3"><enum>(15)</enum><header>Consolidated Appropriations act, 2021</header><text>The Consolidated Appropriations Act, 2021 (<external-xref legal-doc="public-law" parsable-cite="pl/116/260">Public Law 116–260</external-xref>) is amended—</text><subparagraph id="H2A1ABCD53B314798BBBFC0DB0322218B"><enum>(A)</enum><text>in title IX of division N—</text><clause id="H435FDB80674B44FDBDA76CA4EF0F348F"><enum>(i)</enum><text display-inline="yes-display-inline">in section 902(a)(2), in the heading, by striking <quote><header-in-text level="paragraph" style="OLC">Assistant secretary</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Under secretary</header-in-text></quote>;</text></clause><clause id="H0BF1D5703D5140CAB6259F4DE2D15D8F"><enum>(ii)</enum><text>in section 905—</text><subclause id="HF2FB2ADB34924B79816B7828AE951EEE"><enum>(I)</enum><text display-inline="yes-display-inline">in subsection (a)(1), in the heading, by striking <quote><header-in-text level="paragraph" style="OLC">Assistant secretary</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Under secretary</header-in-text></quote>;</text></subclause><subclause id="H50C55388A6BE48158A8B37007868F8D8"><enum>(II)</enum><text display-inline="yes-display-inline">in subsection (c)(3)(B), in the heading, by striking <quote><header-in-text level="paragraph" style="OLC">assistant secretary</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">under secretary</header-in-text></quote>;</text></subclause><subclause id="HE1CEF88B20E1449B98DBA1DDED61EF6C"><enum>(III)</enum><text display-inline="yes-display-inline">in subsection (d)(2)(B), in the heading, by striking <quote><header-in-text level="paragraph" style="OLC">assistant secretary</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">under secretary</header-in-text></quote>; and</text></subclause></clause><clause id="HECDEBFA96A9F430DBC141AAB30599C71"><enum>(iii)</enum><text display-inline="yes-display-inline">by striking <quote>Assistant Secretary</quote> each place the term appears (except in section 905(a)(13)(E)) and inserting <quote>Under Secretary</quote>; and</text></clause></subparagraph><subparagraph id="H33A12D2C16AC4D1FBCB03A8128201FC1"><enum>(B)</enum><text>in title IX of division FF—</text><clause id="H83BA0D461DBC491BBD054FA766C4C76B"><enum>(i)</enum><text display-inline="yes-display-inline">in section 903(g)(2), in the heading, by striking <quote><header-in-text level="paragraph" style="OLC">Assistant secretary</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Under secretary</header-in-text></quote>; and</text></clause><clause id="HBAD6DF7D8F3C4336BC5A022FAE101126"><enum>(ii)</enum><text>by striking <quote>Assistant Secretary</quote> each place the term appears and inserting <quote>Under Secretary</quote>.</text></clause></subparagraph></paragraph><paragraph id="H5B78644695D949F58EE93D54FD5F72B0"><enum>(16)</enum><header>Infrastructure investment and jobs act</header><text>The Infrastructure Investment and Jobs Act (<external-xref legal-doc="public-law" parsable-cite="pl/117/58">Public Law 117–58</external-xref>) is amended—</text><subparagraph id="HCE60041F31DE439B87B0A76702986F92"><enum>(A)</enum><text>in section 27003, by striking <quote>Assistant Secretary</quote> each place the term appears and inserting <quote>Under Secretary</quote>;</text></subparagraph><subparagraph id="H40B2D4BD4D3F4EB5A86035BBB4833105"><enum>(B)</enum><text>in division F—</text><clause id="H64BD19E4207440FBB64AD82B525E8E15"><enum>(i)</enum><text>in section 60102—</text><subclause id="HD075AF56CF544BCFBB49E2168CD4C096"><enum>(I)</enum><text display-inline="yes-display-inline">in subsection (a)(2)(A), by striking <quote><header-in-text level="paragraph" style="OLC">Assistant secretary</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Under secretary</header-in-text></quote>;</text></subclause><subclause id="H6196687C79174E7C829771607E3C909B"><enum>(II)</enum><text display-inline="yes-display-inline">in subsection (d)(1), by striking <quote><header-in-text level="paragraph" style="OLC">Assistant secretary</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Under secretary</header-in-text></quote>; and</text></subclause><subclause id="H64DF68F72C1048CA8E0CFA024FAEA192"><enum>(III)</enum><text>in subsection (h)—</text><item id="HB6BD97E76C864EF191357F19462D3089"><enum>(aa)</enum><text display-inline="yes-display-inline">in paragraph (1)(B), by striking <quote><header-in-text level="paragraph" style="OLC">assistant secretary</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">under secretary</header-in-text></quote>; and</text></item><item id="H79027336AE874D45B12B2A5CF9C1937B"><enum>(bb)</enum><text display-inline="yes-display-inline">in paragraph (5)(B)(iii), by striking <quote><header-in-text level="paragraph" style="OLC">assistant secretary</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">under secretary</header-in-text></quote>;</text></item></subclause></clause><clause id="H737A6BA52EA84A63A9995C3108190328"><enum>(ii)</enum><text>in title III—</text><subclause id="H9111B511BFE04B00A37194D8072B8410"><enum>(I)</enum><text display-inline="yes-display-inline">in section 60302(5), by striking <quote><header-in-text level="paragraph" style="OLC">Assistant secretary</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Under secretary</header-in-text></quote>; and</text></subclause><subclause id="H6E1F8C19D2264CA4857E1C002593E8D9"><enum>(II)</enum><text display-inline="yes-display-inline">in section 60305(d)(2)(B)(ii), by striking <quote><header-in-text level="paragraph" style="OLC">assistant secretary</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">under secretary</header-in-text></quote>;</text></subclause></clause><clause id="H63B6FD0E94DA47AC823983F87676342C"><enum>(iii)</enum><text display-inline="yes-display-inline">in section 60401(a)(2), by striking <quote><header-in-text level="paragraph" style="OLC">Assistant secretary</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Under secretary</header-in-text></quote>; </text></clause><clause id="H89F3B695289148C1AEAB948A19047424"><enum>(iv)</enum><text>by striking <quote>Assistant Secretary</quote> each place the term appears and inserting <quote>Under Secretary</quote>; and</text></clause></subparagraph><subparagraph id="H9E2CFA52373F43C6A0D65EF1CC808C6B" commented="no"><enum>(C)</enum><text>in division J, in title I, in the matter under the heading <quote>distance learning, telemedicine, and broadband program</quote> under the heading <quote>Rural Utilities Service</quote> under the heading <quote>RURAL DEVELOPMENT PROGRAMS</quote>, by striking <quote>Assistant Secretary</quote> and inserting <quote>Under Secretary</quote>.</text></subparagraph></paragraph></subsection></section><section id="H40EEA3883FBA4138B3BE230B74182082"><enum>1612.</enum><header>NTIA Consolidated Reporting Act</header><subsection id="HE76323B573CA4C91B091262418DA30C5"><enum>(a)</enum><header>Elimination of certain outdated or completed reporting requirements</header><paragraph id="H504557F1E056456785A6AFD3A227B798"><enum>(1)</enum><header>BTOP quarterly report</header><text display-inline="yes-display-inline">Section 6001(d) of the American Recovery and Reinvestment Act of 2009 (<external-xref legal-doc="usc" parsable-cite="usc/47/1305">47 U.S.C. 1305(d)</external-xref>) is amended—</text><subparagraph id="HEE9E38978B374F7A8096E2B6BD68DBEE"><enum>(A)</enum><text>in paragraph (2), by striking the semicolon at the end and inserting <quote>; and</quote>;</text></subparagraph><subparagraph id="HB13B12A9F1264AA9808932A83EB272E7"><enum>(B)</enum><text>in paragraph (3), by striking <quote>; and</quote> and inserting a period; and</text></subparagraph><subparagraph id="H0B65DDAE21D247368A3C0B8B45DD65FA" commented="no"><enum>(C)</enum><text>by striking paragraph (4).</text></subparagraph></paragraph><paragraph id="H78E7AD7FE4E14854832A47B9748B5005"><enum>(2)</enum><header>Certain reports required by National Telecommunications and Information Administration Organization Act</header><text display-inline="yes-display-inline">Sections 154, 155, and 156 of the National Telecommunications and Information Administration Organization Act are repealed.</text></paragraph><paragraph id="HCB9C34E65B204F9B85A5902E3B6BFB00" commented="no"><enum>(3)</enum><header>Initial report required by section 9202<enum-in-header>(a)(1)(G)</enum-in-header> of the NDAA for Fiscal Year 2021</header><text display-inline="yes-display-inline">Section 9202(a)(1)(G) of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (<external-xref legal-doc="usc" parsable-cite="usc/47/906">47 U.S.C. 906(a)(1)(G)</external-xref>) is amended—</text><subparagraph id="H4FECA5CA7A994FD2A86A475B559870C3" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">in clause (ii), by redesignating subclauses (I), (II), and (III) as clauses (i), (ii), and (iii), respectively, and conforming the margins of such clauses accordingly; and</text></subparagraph><subparagraph id="HD4FB57F303E64ADF928F9823AFC007D7" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote><header-in-text level="subparagraph" style="OLC">Reports to Congress</header-in-text></quote> and all that follows through <quote>For each fiscal year</quote> and inserting <quote><header-in-text level="subparagraph" style="OLC">Annual report to Congress.—</header-in-text>For each fiscal year</quote>.</text></subparagraph></paragraph><paragraph id="H8F6959D8383B44728DD6C590E92B9FF6" commented="no"><enum>(4)</enum><header>Report to President</header><text>Section 105(a) of the National Telecommunications and Information Administration Organization Act (<external-xref legal-doc="usc" parsable-cite="usc/47/904">47 U.S.C. 904(a)</external-xref>) is amended—</text><subparagraph id="HDC1D4E20B056463F917B238C9B1291A5"><enum>(A)</enum><text>by striking paragraph (2); and</text></subparagraph><subparagraph id="H9A815370CCD544D8943F04E219EB3365"><enum>(B)</enum><text>by redesignating paragraph (3) as paragraph (2).</text></subparagraph></paragraph><paragraph id="HC45C5544275F4D9E90E93DC97B452112"><enum>(5)</enum><header>Effect on authority</header><text display-inline="yes-display-inline">Nothing in this subsection or the amendments made by this subsection may be construed to expand or contract the authority of the Secretary, the Under Secretary, the NTIA, or the Commission.</text></paragraph><paragraph id="HD3FB3E7ECC04455CAC76D94AC9576756"><enum>(6)</enum><header>Other reports</header><text display-inline="yes-display-inline">Nothing in this subsection or the amendments made by this subsection may be construed to prohibit or otherwise prevent the Secretary, the Under Secretary, the NTIA, or the Commission from producing any additional reports otherwise within the authority of the Secretary, the Under Secretary, the NTIA, or the Commission, respectively.</text></paragraph></subsection><subsection id="HA4599AB8BC1E4039A54365778B51BC59" commented="no"><enum>(b)</enum><header>Consolidated annual report</header><paragraph id="HEE4967B7ED6848FFBB3BEB572F515463" commented="no"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">In the first quarter of each calendar year, the Under Secretary shall publish on the website of the NTIA and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Commerce, Science, and Transportation of the Senate a report that contains the reports described in paragraph (2) for the fiscal year ending most recently before the beginning of such quarter.</text></paragraph><paragraph id="H60D748DA8AA044E1B12FFB869EF9880C" commented="no"><enum>(2)</enum><header>Reports described</header><text>The reports described in this paragraph are the following:</text><subparagraph id="H2E3C6EB59A6249B5B4A502F6618D19AB" commented="no"><enum>(A)</enum><text>The report required by section 903(c)(2)(C) of division FF of the Consolidated Appropriations Act, 2021 (<external-xref legal-doc="usc" parsable-cite="usc/47/1307">47 U.S.C. 1307(c)(2)(C)</external-xref>).</text></subparagraph><subparagraph id="HCFB90F99E9A74EE589BD907D9C19460A" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">If amounts in the Public Wireless Supply Chain Innovation Fund established by section 9202(a)(1)(A)(i) of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (<external-xref legal-doc="usc" parsable-cite="usc/47/906">47 U.S.C. 906(a)(1)(A)(i)</external-xref>) were available for the fiscal year described in paragraph (1) of this subsection, the report required by section 9202(a)(1)(G) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/47/906">47 U.S.C. 906(a)(1)(G)</external-xref>).</text></subparagraph><subparagraph id="HD016D26876A541CAA363B53C4B1894F2" commented="no"><enum>(C)</enum><text display-inline="yes-display-inline">If the Under Secretary awarded grants under section 60304(d)(1) of the Infrastructure Investment and Jobs Act (<external-xref legal-doc="usc" parsable-cite="usc/47/1723">47 U.S.C. 1723(d)(1)</external-xref>) in the fiscal year described in paragraph (1) of this subsection, the report required by section 60306(a)(1)(A) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/47/1725">47 U.S.C. 1725(a)(1)(A)</external-xref>).</text></subparagraph></paragraph><paragraph id="H1A33D7D0D0D240A0B6926758F5E865A9" commented="no"><enum>(3)</enum><header>Timing of underlying reporting requirements</header><subparagraph id="HD88FB06B9D8D434291FDA92912332EAB" commented="no"><enum>(A)</enum><header>Report of Office of Internet Connectivity and Growth</header><text display-inline="yes-display-inline">Section 903(c)(2)(C) of division FF of the Consolidated Appropriations Act, 2021 (<external-xref legal-doc="usc" parsable-cite="usc/47/1307">47 U.S.C. 1307(c)(2)(C)</external-xref>) is amended—</text><clause id="H4BDAA56B176640D2BD5DD11ABAB0C6CE" commented="no"><enum>(i)</enum><text>in the matter preceding clause (i)—</text><subclause id="H7A30FE101F6F4A27BDD003723A895B78" commented="no"><enum>(I)</enum><text>by striking <quote>Not later than 1 year after the date of the enactment of this Act, and every year thereafter,</quote> and inserting <quote>In the first quarter of each calendar year,</quote>;</text></subclause><subclause id="HF71491BF517B4F8C836547D081CF0317" commented="no"><enum>(II)</enum><text>by inserting <quote>, for the fiscal year ending most recently before the beginning of such quarter,</quote> after <quote>a report</quote>; and</text></subclause></clause><clause id="H188E361C253147F0A2D553D0DF758D06" commented="no"><enum>(ii)</enum><text>in clause (i), by striking <quote>for the previous year</quote>. </text></clause></subparagraph><subparagraph id="H12227CA6BDCA4808A49EE82D98A4DAA1" commented="no"><enum>(B)</enum><header>Report on digital equity grant programs</header><text display-inline="yes-display-inline">Section 60306(a)(1) of the Infrastructure Investment and Jobs Act (<external-xref legal-doc="usc" parsable-cite="usc/47/1725">47 U.S.C. 1725(a)(1)</external-xref>) is amended—</text><clause id="HB3BF1818BB474C69BE1593C19E4CB68E" commented="no"><enum>(i)</enum><text>in the matter preceding subparagraph (A), by striking <quote>Not later than 1 year</quote> and all that follows through <quote>shall—</quote> and inserting the following: <quote>For the first fiscal year in which the Under Secretary awards grants under section 60304(d)(1), and each fiscal year thereafter in which the Under Secretary awards grants under such section, the Under Secretary shall—</quote>; and</text></clause><clause id="H51DFCFE880644DD69379845B1E752084" commented="no"><enum>(ii)</enum><text>in subparagraph (A)—</text><subclause id="H164D917841884E7D93D77DF274405CF4" commented="no"><enum>(I)</enum><text>by inserting <quote>in the first quarter of the first calendar year that begins after the end of such fiscal year,</quote> before <quote>submit</quote>; and </text></subclause><subclause id="H9E6C0240A9A84C85BB0D9BBE1FB3D542" commented="no"><enum>(II)</enum><text>by striking <quote>, for the year covered by the report</quote>.</text></subclause></clause></subparagraph></paragraph><paragraph id="H3390C96D1E344206A3DD8BA6673C2CD4" commented="no"><enum>(4)</enum><header>Satisfaction of underlying reporting requirements</header><subparagraph id="H6F2921A9BDBC402B8927F039BDAE42B0" commented="no"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Except as provided in subparagraph (B), the publication and submission of a report as required by paragraph (1) in the first quarter of a calendar year shall be treated as satisfying any requirement to publish or otherwise make publicly available or to submit to Congress or to a committee of Congress a report described in paragraph (2) for the fiscal year ending most recently before the beginning of such quarter.</text></subparagraph><subparagraph id="HCE46A6DEA28F40D48E28896C36C0EBB8" commented="no"><enum>(B)</enum><header>Certain submission requirements</header><text>At the time when the Under Secretary submits a report required by paragraph (1) to the committees described in such paragraph, the Under Secretary shall submit any portion of such report that relates to a report described in paragraph (2)(C) to each committee of Congress not described in paragraph (1) to which such report would (without regard to subparagraph (A) of this paragraph) be required to be submitted.</text></subparagraph></paragraph><paragraph id="HEF366C46D7EA4BE6B2D3113946B0BF20" commented="no"><enum>(5)</enum><header>Applicability</header><text>Paragraph (1), and the amendments made by paragraph (3), shall apply beginning on January 1 of the first calendar year that begins after the date of the enactment of this Act.</text></paragraph></subsection><subsection id="H07899D785C2742EB9378A0D78CDCB514"><enum>(c)</enum><header>Extension of certain audit and reporting requirements</header><text>Section 902(c)(4)(A) of division N of the Consolidated Appropriations Act, 2021 (<external-xref legal-doc="usc" parsable-cite="usc/47/1306">47 U.S.C. 1306(c)(4)(A)</external-xref>) is amended by striking <quote>fiscal years 2021 and 2022</quote> and inserting <quote>fiscal years 2021, 2022, 2023, and 2024</quote>.</text></subsection><subsection id="HF42F2AF8D86C415BB8BC64C8E1783C6B"><enum>(d)</enum><header>Definition</header><text display-inline="yes-display-inline">In this section, the term <term>Secretary</term> means the Secretary of Commerce.</text></subsection></section></subtitle><subtitle id="H658D43605E9B4C869757D6ECE7C7E6AD"><enum>B</enum><header>Office of Spectrum Management</header><section id="H57DC79A4ACF64F98A366F05994CB7D5C"><enum>1621.</enum><header>Office of Spectrum Management</header><text display-inline="no-display-inline">Part A of the National Telecommunications and Information Administration Organization Act (<external-xref legal-doc="usc" parsable-cite="usc/47/901">47 U.S.C. 901 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block id="HCBEC7F6FC4B34D0692DAA9EAB522B934" style="OLC"><section id="HA88BD529649D4C4A99CD475AFA1D5A0E"><enum>106.</enum><header>Office of Spectrum Management</header><subsection id="HA53D257A89C54326A17F7671C9BFB6D8"><enum>(a)</enum><header>Establishment</header><text>There is established within the NTIA an Office of Spectrum Management (in this section referred to as the <quote>Office</quote>).</text></subsection><subsection id="HE67E6D4800B2404D88396E73552436CC"><enum>(b)</enum><header>Head of office</header><paragraph id="H96EBD8EDF65D41EBBCED64DCF981C677"><enum>(1)</enum><header>In general</header><text>The head of the Office shall be an Associate Administrator for Spectrum Management (in this section referred to as the <quote>Associate Administrator</quote>).</text></paragraph><paragraph id="H1F21466455F0438BB009310BDD3F4919"><enum>(2)</enum><header>Requirement to report</header><text>The Associate Administrator shall report to the Under Secretary (or a designee of the Under Secretary).</text></paragraph></subsection><subsection id="HE83F6279AECE43D0A797C7DA96EB5564"><enum>(c)</enum><header>Duties</header><text>The Associate Administrator shall, at the direction of the Under Secretary—</text><paragraph id="H3DC70199020844A1B36B8FF0AD0CED47"><enum>(1)</enum><text>carry out responsibilities under section 103(b)(2)(A) (relating to frequency assignments for radio stations belonging to and operated by the United States), make frequency allocations for frequencies that will be used by such stations, and develop and maintain techniques, databases, measurements, files, and procedures necessary for such allocations;</text></paragraph><paragraph id="H69B9F391C28546C896F974B41D5CCC2D"><enum>(2)</enum><text>carry out responsibilities under section 103(b)(2)(K) (relating to establishing policies concerning spectrum assignments and use by radio stations belonging to and operated by the United States) and provide Federal agencies with guidance to ensure that the conduct of telecommunications activities by such agencies is consistent with such policies;</text></paragraph><paragraph id="H90E4D2B47B2A45A7B9B71CF785F74B9B"><enum>(3)</enum><text>represent the interests of Federal agencies in the process through which the Commission and the NTIA jointly determine the National Table of Frequency Allocations, and coordinate with the Commission in the development of a comprehensive long-range plan for improved management of all electromagnetic spectrum resources;</text></paragraph><paragraph id="HCA531A9183174C49AAB0312CFF049C4B"><enum>(4)</enum><text>appoint the chairpersons of and provide secretariat functions for the Interdepartmental Radio Advisory Committee and the Interagency Spectrum Advisory Council;</text></paragraph><paragraph id="HB1285B700CD243A9B87E97332C966BBF"><enum>(5)</enum><text>carry out responsibilities under section 103(b)(2)(B) (relating to authorizing a foreign government to construct and operate a radio station at the seat of Government of the United States) and assign frequencies for use by such stations;</text></paragraph><paragraph id="HDBC0900073944CC6A46DAE9A72C8EF5F"><enum>(6)</enum><text>provide advice and assistance to the Under Secretary and coordinate with the Associate Administrator for International Affairs in carrying out spectrum management aspects of the international policy responsibilities of the NTIA, including spectrum-related responsibilities under section 103(b)(2)(G);</text></paragraph><paragraph id="HEB76A01C599D4CC6934B17D1E9395496"><enum>(7)</enum><text>carry out spectrum-related responsibilities under section 103(b)(2)(H) (relating to coordination of the telecommunications activities of the executive branch and assistance in the formulation of policies and standards for such activities);</text></paragraph><paragraph id="HC0C5EAEFC8BD480E8274C0BD5AFE4BCD"><enum>(8)</enum><text>carry out spectrum-related responsibilities under section 103(b)(2)(Q) (relating to certain activities with respect to telecommunications resources); and</text></paragraph><paragraph id="H7A3D75C024D044A4A2EDA474E62E61D0"><enum>(9)</enum><text>carry out any other duties of the NTIA with respect to spectrum policy that the Under Secretary may designate.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle><subtitle id="H102361ACF3994DF19B9D8BCCDAEBD6B5"><enum>C</enum><header>Office of International Affairs</header><section id="H08A3935A3EEE4A28B968E2E66174AA5C"><enum>1631.</enum><header>Office of International Affairs</header><text display-inline="no-display-inline">Part A of the National Telecommunications and Information Administration Organization Act (<external-xref legal-doc="usc" parsable-cite="usc/47/901">47 U.S.C. 901 et seq.</external-xref>), as amended by the preceding provisions of this title, is further amended by adding at the end the following:</text><quoted-block id="HFB97E6773BDD4BC48618BC2E7F8DA57B" display-inline="no-display-inline" style="OLC"><section id="H01396F5CDCE341679CD60E005A0776A2"><enum>107.</enum><header>Office of International Affairs</header><subsection id="H574CE9610FCA4C9EB58223FC1CB375BB"><enum>(a)</enum><header>Establishment</header><text>There is established within the NTIA an Office of International Affairs (in this section referred to as the <quote>Office</quote>).</text></subsection><subsection id="H3B8CD7ED133B45EE849D1AF69FCDFB24"><enum>(b)</enum><header>Head of office</header><paragraph id="HB35A4A1E927948ED9342C488076FE8EB"><enum>(1)</enum><header>In general</header><text>The head of the Office shall be an Associate Administrator for International Affairs (in this section referred to as the <quote>Associate Administrator</quote>).</text></paragraph><paragraph id="H8ED9E5BDFC78424BA785032C94A2B057"><enum>(2)</enum><header>Requirement to report</header><text>The Associate Administrator shall report to the Under Secretary (or a designee of the Under Secretary).</text></paragraph></subsection><subsection id="HB41092C55EE24E9DBB6604EA60425E7A"><enum>(c)</enum><header>Duties</header><text>The Associate Administrator shall, at the direction of the Under Secretary—</text><paragraph id="H88D96453868D4DEA8C6D6A9CC6588035"><enum>(1)</enum><text>in coordination with the Secretary of State, conduct analysis of, review, and formulate international telecommunications and information policy;</text></paragraph><paragraph id="HA3405938A30E4235BB20BEACC087E106"><enum>(2)</enum><text>present on international telecommunications and information policy—</text><subparagraph id="H74120682CAD14178A8080CB98A26634D"><enum>(A)</enum><text>before the Commission, Congress, and others; and</text></subparagraph><subparagraph id="HA346230F859F48F4BD5B53D5F03CF81B"><enum>(B)</enum><text>in coordination with the Secretary of State, before international telecommunications bodies, including the International Telecommunication Union;</text></subparagraph></paragraph><paragraph id="H1640ED23597E47FEADC30B76DE9F9087"><enum>(3)</enum><text>conduct or obtain analysis on economic and other aspects of international telecommunications and information policy;</text></paragraph><paragraph id="H7FC85CF3633544519BF2D51C2AE8309B"><enum>(4)</enum><text>formulate, and recommend to the Under Secretary, polices and plans with respect to preparation for and participation in international telecommunications and information policy activities;</text></paragraph><paragraph id="HE5DA0A3140A54D3FBE0AC593CF446183"><enum>(5)</enum><text>in coordination with the Secretary of State, coordinate NTIA and interdepartmental economic, technical, operational, and other preparations related to participation by the United States in international telecommunications and information policy conferences and negotiations;</text></paragraph><paragraph id="HE5D31FC965E4465CA694EA597961BE0D"><enum>(6)</enum><text>ensure NTIA representation with respect to international telecommunications and information policy meetings and the activities related to preparation for such meetings;</text></paragraph><paragraph id="H31885648ACC94C3597942E6A2C54C26F"><enum>(7)</enum><text>in coordination with the Secretary of State, coordinate with Federal agencies and private organizations engaged in activities involving international telecommunications and information policy matters and maintain cognizance of the activities of United States signatories with respect to related treaties, agreements, and other instruments;</text></paragraph><paragraph id="H9146373E65E842FE808260792407D91C"><enum>(8)</enum><text>provide advice and assistance related to international telecommunications and information policy to other Federal agencies charged with responsibility for international negotiations, to strengthen the position and serve the best interests of the United States in the conduct of negotiations with foreign nations;</text></paragraph><paragraph id="HEAA5FE8C8D2C422F901B16106EB1AA89"><enum>(9)</enum><text>provide advice and assistance to the Under Secretary with respect to evaluating the international impact of matters pending before the Commission, other Federal agencies, and Congress;</text></paragraph><paragraph id="HE567E7AE888D4DD6A9AA70DBB5AC35D8"><enum>(10)</enum><text>carry out, at the request of the Secretary, the responsibilities of the Secretary under the Communications Satellite Act of 1962 (<external-xref legal-doc="usc" parsable-cite="usc/47/701">47 U.S.C. 701 et seq.</external-xref>) and other Federal laws related to international telecommunications and information policy; and</text></paragraph><paragraph id="H83C43098FE144523BA6CB54B5BD65F5E" commented="no" display-inline="no-display-inline"><enum>(11)</enum><text>carry out any other duties of the NTIA with respect to international telecommunications and information policy that the Under Secretary may designate.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle></title></division><division id="HF3DF5B5717334E40926B64158F81A33F"><enum>C</enum><header>Health</header><title id="H40563B358FB34D019928DE42DEF4AB6D"><enum>I</enum><header>Medicaid</header><section id="H3892D90A0E134D918D1896E368345170"><enum>101.</enum><header>Streamlined enrollment process for eligible out-of-state providers under Medicaid and CHIP</header><subsection id="HF1CA1AB926A641ED9A5DB9A4CED84441"><enum>(a)</enum><header>In general</header><text>Section 1902(kk) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(kk)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HCB6354FA228147C2BB3611C99261FC79"><paragraph id="HB828F4C53D3E40E78BF4AF1C6B31BA19"><enum>(10)</enum><header>Streamlined enrollment process for eligible out-of-state providers</header><subparagraph id="H969BDF3C9B924E78847DB31C881532F4"><enum>(A)</enum><header>In general</header><text>The State—</text><clause id="H2B8DCBA846B94E928DE676CB27FA040E"><enum>(i)</enum><text>adopts and implements a process to allow an eligible out-of-State provider to enroll under the State plan (or a waiver of such plan) to furnish items and services to, or order, prescribe, refer, or certify eligibility for items and services for, qualifying individuals without the imposition of screening or enrollment requirements by such State that exceed the minimum necessary for such State to provide payment to an eligible out-of-State provider under such State plan (or a waiver of such plan), such as the provider's name and National Provider Identifier (and such other information specified by the Secretary); and</text></clause><clause id="HAA606150DDF3423C9FE9D81FAFECB269"><enum>(ii)</enum><text>provides that an eligible out-of-State provider that enrolls as a participating provider in the State plan (or a waiver of such plan) through such process shall be so enrolled for a 5-year period, unless the provider is terminated or excluded from participation during such period.</text></clause></subparagraph><subparagraph id="H8BBDD436DFD640A699D628E383EFF94F"><enum>(B)</enum><header>Definitions</header><text>In this paragraph:</text><clause id="H197C1357DFAA48A6A038B084C46C12B5"><enum>(i)</enum><header>Eligible out-of-state provider</header><text>The term <term>eligible out-of-State provider</term> means, with respect to a State, a provider—</text><subclause id="H0FA52058116641B4A589052B83C7643E"><enum>(I)</enum><text>that is located in any other State;</text></subclause><subclause id="H6A7962AFC6484DD58DF441467F8A577E"><enum>(II)</enum><text>that—</text><item id="H5ABC86A4F8F94A7CBD62571291823781"><enum>(aa)</enum><text>was determined by the Secretary to have a limited risk of fraud, waste, and abuse for purposes of determining the level of screening to be conducted under section 1866(j)(2), has been so screened under such section 1866(j)(2), and is enrolled in the Medicare program under title XVIII; or</text></item><item id="HC944A4B95F6043BB9DD5C68E0B364546"><enum>(bb)</enum><text>was determined by the State agency administering or supervising the administration of the State plan (or a waiver of such plan) of such other State to have a limited risk of fraud, waste, and abuse for purposes of determining the level of screening to be conducted under paragraph (1) of this subsection, has been so screened under such paragraph (1), and is enrolled under such State plan (or a waiver of such plan); and</text></item></subclause><subclause id="H0E56650AC2074C58A0C4CD250A6FA715"><enum>(III)</enum><text>that has not been—</text><item id="H2D9FE8C4FFA1404DABD4B53411BF74CC"><enum>(aa)</enum><text>excluded from participation in any Federal health care program pursuant to section 1128 or 1128A;</text></item><item id="H2BCD879178754FBFB4C94C60635B4C79"><enum>(bb)</enum><text>excluded from participation in the State plan (or a waiver of such plan) pursuant to part 1002 of title 42, Code of Federal Regulations (or any successor regulation), or State law; or</text></item><item id="H88ADD40DF4014E9E84CB6CB41123C063"><enum>(cc)</enum><text>terminated from participating in a Federal health care program or the State plan (or a waiver of such plan) for a reason described in paragraph (8)(A).</text></item></subclause></clause><clause id="HE3F3AE84FC3D48D092FCCB2DD2F5426B"><enum>(ii)</enum><header>Qualifying individual</header><text>The term <term>qualifying individual</term> means an individual under 21 years of age who is enrolled under the State plan (or waiver of such plan).</text></clause><clause id="HDF7F289558BF4137BDF3EE5D95F00D4C"><enum>(iii)</enum><header>State</header><text>The term <term>State</term> means 1 of the 50 States or the District of Columbia.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HAC589848ECA84123B9BAEDFCE4FE02DD"><enum>(b)</enum><header>Conforming amendments</header><paragraph id="H3FC76135E7AB4AB78C704535FE22A924"><enum>(1)</enum><text>Section 1902(a)(77) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(a)(77)</external-xref>) is amended by inserting <quote>enrollment,</quote> after <quote>screening,</quote>.</text></paragraph><paragraph id="HCFC826CE48894187BBAC7A44CFB23468"><enum>(2)</enum><text>The subsection heading for section 1902(kk) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(kk)</external-xref>) is amended by inserting <quote>enrollment,</quote> after <quote>screening,</quote>.</text></paragraph><paragraph id="H3498407C98104A36A06A77BC44097F8D"><enum>(3)</enum><text>Section 2107(e)(1)(G) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1397gg">42 U.S.C. 1397gg(e)(1)(G)</external-xref>) is amended by inserting <quote>enrollment,</quote> after <quote>screening,</quote>.</text></paragraph></subsection><subsection id="H93F9241BB4ED4DC48D1F4111B115CDC6"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall take effect on the date that is 3 years after the date of enactment of this Act.</text></subsection></section><section id="H908A95F960614496830FA5C375C50105"><enum>102.</enum><header>Making certain adjustments to coverage of home or community-based services under Medicaid</header><subsection commented="no" display-inline="no-display-inline" id="HF8580B7A970944B3AA4C3AC6E2051FAB"><enum>(a)</enum><header display-inline="yes-display-inline">Increasing transparency of HCBS coverage under Medicaid</header><paragraph commented="no" display-inline="no-display-inline" id="H9C23CF416B2146FABA916B67A2EB1B86"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1915(c) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396n">42 U.S.C. 1396n(c)</external-xref>) is amended—</text><subparagraph id="HE960A299C30E4F7C90438916786EB034"><enum>(A)</enum><text>in paragraph (2)—</text><clause id="H6C1D64A63444405E9624903C142B01AD"><enum>(i)</enum><text>in subparagraph (E)—</text><subclause id="H4AAC0E9C7C4A463EBC02F0E641E75082"><enum>(I)</enum><text>by inserting <quote>, not less frequently than</quote> before <quote>annually</quote>; and</text></subclause><subclause id="HF4AEEB11F5C94105B80CB4AD543D7384"><enum>(II)</enum><text>by inserting <quote>(including, with respect to such information provided on or after July 9, 2027, the information specified in paragraph (11))</quote> before the period at the end; and</text></subclause></clause><clause id="H8188A25D3CA04825B56845D104EF873D"><enum>(ii)</enum><text>by adding at the end the following flush sentence:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H621A26C2FDC04112A30A46FCEE52C30A"><quoted-block-continuation-text quoted-block-continuation-text-level="paragraph">The Secretary shall make all information provided under subparagraph (E) on or after the date of the enactment of this sentence publicly available on the website of the Centers for Medicare &amp; Medicaid Services.</quoted-block-continuation-text><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="H98C4FAF9EF314F31BFEDFEA958190EC1"><enum>(B)</enum><text>by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H173A324DD2314CD4B3612C18B8152ECA"><paragraph id="HBC88417A09BC403AA650A6261BD2B58B"><enum>(11)</enum><text>For purposes of paragraph (2)(E), the information specified in this paragraph is the following:</text><subparagraph id="H22DE7B87399845F299553A2F77D7E1F5"><enum>(A)</enum><text>In the case of a State that limits the number of individuals who may be provided home or community-based services under a waiver granted under this subsection and maintains a list of individuals waiting to enroll in such waiver, a description of how the State maintains such list, including—</text><clause id="H67C242E3A70D4B8CB171074BC2752E8E"><enum>(i)</enum><text>information on whether the State screens individuals on such list to determine whether such individuals are eligible to receive such services under such waiver;</text></clause><clause commented="no" display-inline="no-display-inline" id="HC160E92E32144978AA9E7DF81AD7E56C"><enum>(ii)</enum><text>information on whether (and, if applicable, how often) the State periodically re-screens individuals on such list for eligibility;</text></clause><clause commented="no" display-inline="no-display-inline" id="H99497EDD4C7E49EB8D4C24DA44F10356"><enum>(iii)</enum><text>the number of people on such list of individuals waiting to enroll in such waiver; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H29BAAA3ADCE34E88AB2EFDC41E8FAC4D"><enum>(iv)</enum><text>the average amount of time that individuals newly enrolled in such waiver within the past 12 months were on such list of individuals waiting to enroll in such waiver.</text></clause></subparagraph><subparagraph id="HDC89EBECCBC140B098CA5312C2C53CA9"><enum>(B)</enum><text>With respect to homemaker services, home health aide services, personal care services, and habilitation services furnished under waivers under this subsection, by each such service type—</text><clause id="H079D6EDE98DD463B8985BF1C2F0A3634"><enum>(i)</enum><text> for individuals newly receiving such services within the past 12 months, the average amount of time (which may be determined using statistically valid random sampling of such individuals) from when such services are initially approved for such an individual to when such individual begins receiving such services; and</text></clause><clause id="HBFD44DEE42BD42F998ADC74B7FE87168" commented="no"><enum>(ii)</enum><text>the percentage of authorized hours (which may be determined using statistically valid random sampling of individuals authorized to receive such services) that are provided within the past 12 months.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HBF954AF7714A4C42A334348F7425B42B"><enum>(2)</enum><header>Conforming amendments</header><text>Section 1915 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396n">42 U.S.C. 1396n</external-xref>) is amended—</text><subparagraph commented="no" display-inline="no-display-inline" id="H307BB0C122A54E0CA3A6695F7133F78A"><enum>(A)</enum><text>in subsection (i) by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H0B3DD3EE4883400F829369C902FE0B7F"><paragraph commented="no" display-inline="no-display-inline" id="HB0246039A4714D22B35F46E1018A5575"><enum>(8)</enum><header>Reporting requirement</header><text>With respect to homemaker services, home health aide services, personal care services, and habilitation services provided under this subsection on or after July 9, 2027, the State, not less frequently than annually, shall provide to the Secretary the same information regarding such services as the State is required to provide under subsection (c)(11)(B).</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H96BDB18697354D7ABD85ED93B3696CD4"><enum>(B)</enum><text>in subsection (j)(2)(E), by inserting after the second sentence the following: <quote>With respect to any homemaker services, home health aide services, personal care services, and habilitation services provided under this subsection on or after July 9, 2027, the State, not less frequently than annually, shall provide to the Secretary the same information regarding such services as the State is required to provide under subsection (c)(11)(B).</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HECCFC5A64E20460FB48037D40A3969C1"><enum>(C)</enum><text>in subsection (k)(3)(E)—</text><clause commented="no" display-inline="no-display-inline" id="HFF7239FE3C5A4583B29B4A046A900243"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>and</quote> after <quote>the cost of such services and supports,</quote>; and</text></clause><clause id="H1F6B6EB051D841C185B6312EDBCAABE9"><enum>(ii)</enum><text>by inserting before the period, the following: <quote>, and with respect to homemaker services, home health aide services, personal care services, and habilitation services provided under this subsection on or after July 9, 2027, not less frequently than annually, the same information regarding such services as the State is required to provide under subsection (c)(11)(B)</quote>.</text></clause></subparagraph></paragraph></subsection><subsection id="H60826AC19BA449409714BAA24898AF0F"><enum>(b)</enum><header>Demonstration program To expand HCBS coverage under section 1915(c) waivers</header><text>Section 1915(c) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396n">42 U.S.C. 1396n(c)</external-xref>), as amended by subsection (a), is further amended—</text><paragraph id="H7C01397E510A4B9F84A0E728C65E62A8"><enum>(1)</enum><text>in paragraph (2)(E), by inserting <quote>, and the information specified in paragraph (12)(C)(v), when applicable</quote> after <quote>paragraph (11)</quote>; and</text></paragraph><paragraph id="H02C8813FFE9F4F7B9B570CB931E25FDC"><enum>(2)</enum><text>by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H4DD2671E5C1948A48DCD53723CD6CF34"><paragraph id="HE3ABEE2FDBCB4F05B86EADC10393F4D8"><enum>(12)</enum><header>Demonstration program to expand coverage for home or community-based services</header><subparagraph commented="no" display-inline="no-display-inline" id="H2445CB72BE0C4DB883A3EFD17B142C25"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><clause commented="no" display-inline="no-display-inline" id="HD54FC2EA9C354E34BB11882D8F2BBF5A"><enum>(i)</enum><header display-inline="yes-display-inline">Approval</header><text>Not later than 24 months after the date on which the planning grants under subparagraph (B) are awarded, notwithstanding paragraph (1), the Secretary may approve a waiver that is standalone from any other waiver approved under this subsection for not more than 5 States, selected in accordance with clause (ii), to include as medical assistance under the State plan of such State, for the 3-year period beginning on the date of such approval, payment for part or all of the cost of home or community-based services (other than room and board (as described in paragraph (1))) approved by the Secretary which are provided pursuant to a written plan of care to individuals described in subparagraph (C)(iii).</text></clause><clause commented="no" display-inline="no-display-inline" id="HBD30DEE17FDA4AE69D7FDB9E8F7B8948"><enum>(ii)</enum><header>Selection criteria</header><text>In selecting States for purposes of clause (i), the Secretary shall—</text><subclause id="H12F4C6595A314A41886EFB2514B5F0E9"><enum>(I)</enum><text>only select States that received a planning grant under subparagraph (B);</text></subclause><subclause id="HB560FA4E4974443DB284266B698207A3"><enum>(II)</enum><text>only select States that meet the requirements specified in subparagraph (C) and such other requirements as the Secretary may determine appropriate;</text></subclause><subclause id="H688F0E933D7C487382AD7832010335D9"><enum>(III)</enum><text>select States in a manner that ensures geographic diversity;</text></subclause><subclause id="H21C75CAEF16643C4BC046B99653778AA"><enum>(IV)</enum><text>give preference to States with a higher percentage (relative to other States that apply to be selected for purposes of clause (i)) of the total State population residing in rural areas (as determined by the Secretary);</text></subclause><subclause id="H2D516A6180B648A9BB197DAD8D287F15"><enum>(V)</enum><text>give preference to States that have demonstrated more progress in rebalancing long-term services and supports systems under this title, as determined based on the relative share of individuals who use home or community-based services (as defined by the Secretary) under this title as a percentage of total individuals who use long-term services and supports (as defined by the Secretary) under this title (in the most recent year for which such data is available); and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HB0D86C99E09F4A038598F0864E8C03AC"><enum>(VI)</enum><text>give preference to States that pursue a waiver under this paragraph that incorporates the provision of mental health services for adults with serious mental illness, children with serious emotional disturbances, or individuals with substance use disorder.</text></subclause></clause></subparagraph><subparagraph id="HE21DA0774AA441979F2DC61037969839"><enum>(B)</enum><header>Planning grants</header><clause commented="no" display-inline="no-display-inline" id="HC173D0CBD7804093890417C388A70AFC"><enum>(i)</enum><header>In general</header><subclause commented="no" display-inline="no-display-inline" id="HF6FC8AC9F5B84CCFA4A579289A38C05E"><enum>(I)</enum><header>Approval</header><text display-inline="yes-display-inline">Not later than 18 months after the date of the enactment of this paragraph, the Secretary shall award planning grants of not more than $5,000,000 each to not more than 10 States for purposes of preparing to submit a request for a waiver under this subsection (including for costs to implement the waiver or other activities to expand the provision of home or community-based services under this section) to provide home or community-based services to individuals described in subparagraph (C)(iii).</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H4BCB6A32E31A48E49B92ACD1092EA7EB"><enum>(II)</enum><header>Selection criteria</header><text>In awarding planning grants under subclause (I), the Secretary shall use the selection criteria specified in subclauses (III) through (VI) of subparagraph (A)(ii).</text></subclause></clause><clause id="HF9910B1361724DC6BC8B7308D4706415"><enum>(ii)</enum><header>Consultation</header><text>A State that is awarded a planning grant under clause (i) shall, in preparing to submit a request for a waiver described in such clause, consult with—</text><subclause id="H02FADCA76B194A4FB3B8A104E47AE773"><enum>(I)</enum><text>individuals in need of (and not receiving) home or community-based services, individuals receiving home or community-based services, and the caregivers of such individuals;</text></subclause><subclause id="H53294023F8D94B1DB1FECC2B8A523533"><enum>(II)</enum><text>providers furnishing home or community-based services; and</text></subclause><subclause id="H61074EB4F6A34BCAAB21CA9F27C59A76"><enum>(III)</enum><text>such other stakeholders, as the Secretary may specify.</text></subclause></clause></subparagraph><subparagraph id="HE609286F84A245CD9DD488013F0A5D2E"><enum>(C)</enum><header>State requirements</header><text>In addition to the requirements specified under this subsection (except for the requirements described in subparagraphs (C) and (D) of paragraph (2) and any other requirement the Secretary determines to be inapplicable in the context of a waiver relation to individuals who do not require the level of care described in paragraph (1)), the requirements specified in this paragraph are, with respect to a State, the following:</text><clause id="HFB2FB38165DD414E9539EA642FB0CBA8"><enum>(i)</enum><text>As of the date that such State requests a waiver under this subsection to provide home or community-based services to individuals described in clause (iii), all other waivers (if any) granted under this subsection to such State meet the requirements of this subsection.</text></clause><clause id="H06D01F280A214DCCAAF2A3EAC9770F9A"><enum>(ii)</enum><text>The State demonstrates to the Secretary that approval of a waiver under this subsection with respect to individuals described in clause (iii) will not result in a material increase of the average amount of time that individuals with respect to whom a determination described in paragraph (1) has been made will need to wait to receive home or community-based services under any waiver granted under this subsection, as determined by the Secretary.</text></clause><clause id="H0928BA49B70F422B973F433EFA824A77"><enum>(iii)</enum><text>The State establishes needs-based criteria, subject to the approval of the Secretary, to identify individuals for whom a determination described in paragraph (1) is not applicable, who will be eligible for home or community-based services under a waiver approved under this paragraph, and specifies the home or community-based services such individuals so eligible will receive.</text></clause><clause commented="no" display-inline="no-display-inline" id="HFC775A0E32644066B0E4D0945893748D"><enum>(iv)</enum><text>The State established needs-based criteria for determining whether an individual described in clause (iii) requires the level of care provided in a hospital, nursing facility, or an intermediate care facility for individuals with developmental disabilities under the State plan or under any waiver of such plan that are more stringent than the needs-based criteria established under clause (iii) for determining eligibility for home or community-based services.</text></clause><clause commented="no" display-inline="no-display-inline" id="H38AEFFBE60F145268240D771EBBF9A0C"><enum>(v)</enum><text>The State attests that the State's average per capita expenditure for medical assistance under the State plan (or waiver of such plan) provided with respect to such individuals enrolled in a waiver under this paragraph will not exceed the State's average per capita expenditures for medical assistance for individuals receiving institutional care under the State plan (or waiver of such plan) for the duration that the waiver under this paragraph is in effect.</text></clause><clause id="HC7DF941B848347CBB8356C42BF64DFB7"><enum>(vi)</enum><text>The State provides to the Secretary data (in such form and manner as the Secretary may specify) regarding the number of individuals described in clause (i) with respect to a State seeking approval of a waiver under this subsection, to whom the State will make such services available under such waiver.</text></clause><clause id="H546E0E1C49FC493E954B5EEF59D1FCBF"><enum>(vii)</enum><text>The State agrees to provide to the Secretary, not less frequently than annually, data for purposes of paragraph (2)(E) (in such form and manner as the Secretary may specify) regarding, with respect to each preceding year in which a waiver under this subsection to provide home and community-based services to individuals described in clause (iii) was in effect—</text><subclause id="HDCC08C2AA23C4FBFB3C0253577639ED3"><enum>(I)</enum><text>the cost (as such term is defined by the Secretary) of such services furnished to individuals described in clause (iii), broken down by type of service;</text></subclause><subclause id="H8E60447EF5DB4F20B81CAD09420FC44E"><enum>(II)</enum><text>with respect to each type of home and community-based service provided under the waiver, the length of time that such individuals have received such service;</text></subclause><subclause id="H01F74365F3C04515ABCAD85B47FE877F"><enum>(III)</enum><text>a comparison between the data described in subclause (I) and any comparable data available with respect to individuals with respect to whom a determination described in paragraph (1) has been made and with respect to individuals receiving institutional care under this title; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HA67D0BD304D044619D849516751E1FDD"><enum>(IV)</enum><text>the number of individuals who have received home and community-based services under the waiver during the preceding year.</text></subclause></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HC6E2C107F4C5440CA5EDD1D99F36A615"><enum>(c)</enum><header>Non-Application of the Paperwork Reduction Act</header><text><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/44/35">Chapter 35</external-xref> of title 44, United States Code (commonly referred to as the “Paperwork Reduction Act of 1995”), shall not apply to the implementation of the amendments made by subsections (a) and (b).</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H1E42BB02814E4CFB8DA29D8345037DA6"><enum>(d)</enum><header>CMS guidance to States on interim coverage under section 1915 home and community-Based services authorities</header><text>Not later than January 1, 2027, the Secretary of Health and Human Services shall issue guidance to the States to clarify how a State may provide, with respect to an individual who is eligible for home and community-based services under section 1915 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396n">42 U.S.C. 1396n</external-xref>), coverage of such services pursuant to a provisional written plan of care, pending finalization, with respect to such individual.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H9CA971C3680346579D7B1F3147CC5536"><enum>(e)</enum><header>Funding</header><paragraph commented="no" display-inline="no-display-inline" id="H51188A34CD904AC09337FAEB6EAA2826"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">There are appropriated, out of any funds in the Treasury not otherwise obligated, $71,000,000 for fiscal year 2025, to remain available until expended, to the Secretary of Health and Human Services for purposes of carrying out subsection (d) and the amendments made by subsection (b).</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HCC78CDBE14624B24B84E97AB56E6D464"><enum>(2)</enum><header>Reservation for planning grants</header><text>Of the amount appropriated under paragraph (1), the Secretary of Health and Human Services shall reserve $50,000,000 of such amount to award planning grants under the demonstration program established by the amendments made by subsection (b). </text></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H162F7BF2848D425C8361F2BA0E5006BA"><enum>103.</enum><header>Removing certain age restrictions on Medicaid eligibility for working adults with disabilities</header><subsection id="H087F5C4BABBE422BB87CABCD13921503"><enum>(a)</enum><header>Modification of optional buy-In groups</header><paragraph id="HB9B820E3688D436FB2E8089AE7FBF4DD"><enum>(1)</enum><header>In general</header><text>Section 1902(a)(10)(A)(ii)(XV) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(a)(10)(A)(ii)(XV)</external-xref>) is amended by striking <quote>but less than 65,</quote>.</text></paragraph><paragraph id="HA5EFB191A0744E718A4D1141A874A9F7"><enum>(2)</enum><header>Definition modification</header><text>Section 1905(v)(1)(A) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396d">42 U.S.C. 1396d(v)(1)(A)</external-xref>) is amended by striking <quote>, but less than 65,</quote>.</text></paragraph></subsection><subsection id="H70BD94360B0941ACA127FB4E1D24AD52" commented="no" display-inline="no-display-inline"><enum>(b)</enum><header>Application to certain States</header><text>A State that, as of the date of enactment of this Act, provides for making medical assistance available to individuals described in subclause (XV) or (XVI) of section 1902(a)(10)(A)(ii) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(a)(10)(A)(ii)</external-xref>) shall not be regarded as failing to comply with the requirements of either such subclause (as amended by subsection (a)(1)) or with section 1905(v)(1)(A) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396d">42 U.S.C. 1396d(v)(1)(A)</external-xref>) (as amended by subsection (a)(2)) before January 1, 2027. </text></subsection></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="HE971AE3FB17548949FA576D7BDF31930"><enum>104.</enum><header>Medicaid State plan requirement for determining residency and coverage for military families</header><subsection commented="no" display-inline="no-display-inline" id="H2FC5E5AC19E74FBB93754E8B919F4FE4"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 1902 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="HBEC8D517BA18403A9717588D38207CB1"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)—</text><subparagraph commented="no" display-inline="no-display-inline" id="H753EF5BDE26A468AAD4AE39DA6BCF41E"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (86), by striking <quote>and</quote> at the end;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H388A3274B4E54D8C958685649B4DBE79"><enum>(B)</enum><text>in paragraph (87), by striking the period at the end and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE318955E937D41B0A23C342A037C2FCD"><enum>(C)</enum><text>by inserting after paragraph (87), the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H42414D30F2824E9189B8095583D92811"><paragraph commented="no" display-inline="no-display-inline" id="HEA2430FB374B458F9C5BE31C81AB161B"><enum>(88)</enum><text>beginning January 1, 2028, provide, with respect to an active duty relocated individual (as defined in subsection (uu)(1))—</text><subparagraph commented="no" display-inline="no-display-inline" id="H556E0248461A4EB388F7C08160F2C51E"><enum>(A)</enum><text display-inline="yes-display-inline">that, for purposes of determining eligibility for medical assistance under the State plan (or waiver of such plan), such active duty relocated individual is treated as a resident of the State unless such individual voluntarily elects not to be so treated for such purposes;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC9B5D9085C7D44DFA0470A722C7A1270"><enum>(B)</enum><text>that if, at the time of relocation (as described in subsection (uu)(1)), such active duty relocated individual is on a home and community-based services waiting list (as defined in subsection (uu)(2)), such individual remains on such list until—</text><clause commented="no" display-inline="no-display-inline" id="HA8214D257D5F4D7FACA325E18452F5FA"><enum>(i)</enum><text>the State completes an assessment and renders a decision with respect to the eligibility of such individual to receive the relevant home and community-based services at the time a slot for such services becomes available and, in the case such decision is a denial of such eligibility, such individual has exhausted the individual’s opportunity for a fair hearing; or</text></clause><clause commented="no" display-inline="no-display-inline" id="HA6FC8BC2CBE544169B3E5B19BA0FD9D3"><enum>(ii)</enum><text>such individual elects to be removed from such list; and</text></clause></subparagraph><subparagraph id="HFA3E27A214D441919D1DECE8D4C84B53"><enum>(C)</enum><text>payment for medical assistance furnished under the State plan (or a waiver of the plan) on behalf of such active duty relocated individual in the military service relocation State (as referred to in subsection (uu)(1)(B)(i)), to the extent that such assistance is available in such military service relocation State in accordance with such guidance as the Secretary may issue to ensure access to such assistance.</text></subparagraph></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H5C51D1010FB0483CA600363F22B073CB"><enum>(2)</enum><text>by adding at the end the following new subsection: </text><quoted-block style="OLC" display-inline="no-display-inline" id="H96DB1D8AA59C4F9BBAF401808A887405"><subsection commented="no" display-inline="no-display-inline" id="H0AB4365E47C04ED9AA6C5DCB188629E8"><enum>(uu)</enum><header>Active duty relocated individual; home and community-Based services waiting list</header><text>For purposes of subsection (a)(88) and this subsection: </text><paragraph commented="no" display-inline="no-display-inline" id="HD82E242835F541E58AF3770004264AA0"><enum>(1)</enum><header>Active duty relocated individual</header><text>The term <term>active duty relocated individual</term> means an individual—</text><subparagraph commented="no" display-inline="no-display-inline" id="H4DB1790D83114A9EAA526038837312CB"><enum>(A)</enum><text>who—</text><clause commented="no" display-inline="no-display-inline" id="H21B21D5546804463BF3A25B07CE774B8"><enum>(i)</enum><text>is enrolled under the State plan (or waiver of such plan); or</text></clause><clause commented="no" display-inline="no-display-inline" id="H75104EC024114DAEADE3BAC20959D79D"><enum>(ii)</enum><text>with respect to an individual described in subparagraph (C)(ii), would be so enrolled pursuant to subsection (a)(10)(A)(ii)(VI) if such individual began receiving home and community-based services;</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4577319539404D2EAD12C8FFA4C462A4"><enum>(B)</enum><text>who—</text><clause commented="no" display-inline="no-display-inline" id="H97526B477B9D45ADA86E38A57F9A1717"><enum>(i)</enum><text display-inline="yes-display-inline">is a member of the Armed Forces engaged in active duty service and is relocated to another State (in this subsection referred to as the <quote>military service relocation State</quote>) by reason of such service;</text></clause><clause commented="no" display-inline="no-display-inline" id="HD943B907B5F84E10B3676DAEB18D498E"><enum>(ii)</enum><text>would be described in clause (i) except that the individual stopped being engaged in active duty service (including by reason of retirement from such service) and the last day on which the individual was engaged in active duty service occurred not more than 12 months ago; or </text></clause><clause commented="no" display-inline="no-display-inline" id="H12830D7B75C345BF84795CB5C82B9FAC"><enum>(iii)</enum><text>is a dependent (as defined by the Secretary) of a member described in clause (i) or (ii) who relocates to the military service relocation State with such member; and</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H725603E5372A4EFCA2D053B6D1BE2D00"><enum>(C)</enum><text>who—</text><clause commented="no" display-inline="no-display-inline" id="H2EDEB300AAB8436EA7C1AE6018D491DF"><enum>(i)</enum><text display-inline="yes-display-inline">was receiving home and community-based services (as defined in section 9817(a)(2)(B) of the American Rescue Plan Act of 2021) at the time of such relocation; or</text></clause><clause id="HBBFC6D6E3B4A4C26B68D809780AA80E1"><enum>(ii)</enum><text>if the State maintains a home and community-based services waiting list, was on such home and community-based services waiting list at the time of such relocation. </text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H634145D4C0A74E04ACFFF7493A10DA16"><enum>(2)</enum><header>Home and community-based services waiting list</header><text>The term <term>home and community-based services waiting list</term> means, in the case of a State that has a limit on the number of individuals who may receive home and community-based services under section 1115(a), section 1915(c), or section 1915(j), a list maintained by such State of individuals who are requesting to receive such services under 1 or more such sections but for whom the State has not yet completed an assessment and rendered a decision with respect to the eligibility of such individuals to receive the relevant home and community-based services at the time a slot for such services becomes available due to such limit.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H968F7A19201E44ECB4C654CCAE722EA2"><enum>(b)</enum><header>Implementation funding</header><text>There are appropriated, out of any funds in the Treasury not otherwise obligated, $1,000,000 for each of fiscal years 2025 through 2029, to remain available until expended, to the Secretary of Health and Human Services for purposes of implementing the amendments made by subsection (a). </text></subsection></section><section commented="no" display-inline="no-display-inline" id="H1996B65D78E54EA29CF28A35ED72E65C"><enum>105.</enum><header>Ensuring the reliability of address information provided under the Medicaid program</header><subsection id="H13A2A351582245CBAE9443A782C8BDEB"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1902(a) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(a)</external-xref>), as previously amended by this title, is amended—</text><paragraph id="HC42112B6EF4C4C7F803B73C36E6DDCC4"><enum>(1)</enum><text>in paragraph (87), by striking <quote>and</quote> at the end;</text></paragraph><paragraph id="H52A3E99783A54026A60536AF6BD4662B"><enum>(2)</enum><text>in paragraph (88), by striking the period at the end and inserting <quote>; and</quote>; and</text></paragraph><paragraph id="HFAC93CB565BF44999F7DDCBD629565A8"><enum>(3)</enum><text>by inserting after paragraph (88) the following new paragraph:</text><quoted-block style="OLC" id="H5CBFBBD6DD80487A8A626E260CD946F5" display-inline="no-display-inline"><paragraph id="HBCCD5755E52142F89EB5CDFC3E933AD1"><enum>(89)</enum><text display-inline="yes-display-inline">beginning January 1, 2026, provide for a process to regularly obtain address information for individuals enrolled under such plan (or a waiver of such plan) from reliable data sources (as described in section 435.919(f)(1)(iii) of title 42, Code of Federal Regulations (or a successor regulation)) and act on any changes to such an address based on such information in accordance with such section (or successor regulation), except that this paragraph shall only apply in the case of the 50 States and the District of Columbia.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H1FAFF84811C04D478E0FB520EE9536BE"><enum>(b)</enum><header>Application to CHIP</header><text display-inline="yes-display-inline">Section 2107(e)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1397gg">42 U.S.C. 1397gg(e)(1)</external-xref>) is amended—</text><paragraph id="H27F79F9350744DE39786D6B00E1D04AA"><enum>(1)</enum><text>by redesignating subparagraphs (H) through (U) as subparagraphs (I) through (V), respectively; and</text></paragraph><paragraph id="HA50A3D25E0E447C181AA9E2F4070AEC0"><enum>(2)</enum><text>by inserting after subparagraph (G) the following new subparagraph:</text><quoted-block style="OLC" id="H707D69EEC51A489D8A1D278339395834" display-inline="no-display-inline"><subparagraph id="H4D0FFBD8648147E6950B61C841D75D55"><enum>(H)</enum><text display-inline="yes-display-inline">Section 1902(a)(89) (relating to regularly obtaining address information for enrollees).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HD6B40BE47FD34D668142E357A4387EDD"><enum>(c)</enum><header>Ensuring transmission of address information from managed care organizations</header><text>Section 1932 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396u-2">42 U.S.C. 1396u–2</external-xref>) is amended by adding at the end the following new subsection:</text><quoted-block style="OLC" id="H6A75DC1210684742891A399258022CD2" display-inline="no-display-inline"><subsection id="HE4B3B4893AB74F3387AA4BAB83B1D909"><enum>(j)</enum><header>Transmission of address information</header><text display-inline="yes-display-inline">Beginning January 1, 2026, each contract under a State plan with a managed care entity under section 1903(m) shall provide that the entity transmits to the State any address information for an individual enrolled with the entity that is provided to such entity directly from, or verified by such entity directly with, such individual.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section commented="no" display-inline="no-display-inline" id="HC2038BC70CA34370B436E3017A8B3218"><enum>106.</enum><header>Codifying certain Medicaid provider screening requirements related to deceased providers</header><text display-inline="no-display-inline">Section 1902(kk)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(kk)(1)</external-xref>) is amended—</text><paragraph id="H1A32825364D44DAD91094949C11A20C0"><enum>(1)</enum><text>by striking <quote>The State</quote> and inserting: </text><quoted-block style="OLC" id="HA5928243AF094EE4AF9E4B617DE3D00D" display-inline="no-display-inline"><subparagraph id="HBB56CAB4559B486CA3044D942E294CB6"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The State</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="H4DA844072E27493CA30C253638CEFE4D"><enum>(2)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" id="H03A9595FF2404856A911851B48E33899" display-inline="no-display-inline"><subparagraph id="H24030019E02D482E8F5515065BBFB5CB"><enum>(B)</enum><header>Additional provider screening</header><text display-inline="yes-display-inline">Beginning January 1, 2027, as part of the enrollment (or reenrollment or revalidation of enrollment) of a provider or supplier under this title, and not less frequently than quarterly during the period that such provider or supplier is so enrolled, the State conducts a check of the Death Master File (as such term is defined in section 203(d) of the Bipartisan Budget Act of 2013) to determine whether such provider or supplier is deceased.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section commented="no" display-inline="no-display-inline" id="H7C0A467CED0540FFBCC8087FE27F979A"><enum>107.</enum><header>Modifying certain State requirements for ensuring deceased individuals do not remain enrolled</header><text display-inline="no-display-inline">Section 1902 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a</external-xref>), as previously amended by this title, is amended—</text><paragraph id="H119B162B344149B0BA4E532F24308F51"><enum>(1)</enum><text>in subsection (a)—</text><subparagraph id="H4760F95FEE944E458CD6E433CFB6F18E"><enum>(A)</enum><text>in paragraph (88), by striking <quote>; and</quote> and inserting a semicolon;</text></subparagraph><subparagraph id="H983826A3D17943E090176277F0C22F32"><enum>(B)</enum><text>in paragraph (89), by striking the period at the end and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph id="HB7165348BDD94142A3DAA15B4DEEC684"><enum>(C)</enum><text display-inline="yes-display-inline">by inserting after paragraph (89) the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H732DB103E0CE4E28AC8705F34B940AAB"><paragraph id="H3639E594CF014DC2A3E9737D26C595BD"><enum>(90)</enum><text display-inline="yes-display-inline">provide that the State shall comply with the eligibility verification requirements under subsection (vv), except that this paragraph shall apply only in the case of the 50 States and the District of Columbia.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H9280DAD2E42E4411B114570B19E37481"><enum>(2)</enum><text>by adding at the end the following new subsection:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H8504D173AECE46DBAFACB59C334F52CB"><subsection id="H01EF6CD60AFB4410BCDF42F3A3F592BD"><enum>(vv)</enum><header>Verification of certain eligibility criteria</header><paragraph id="HC7B7647AE82D4B9882C88DC89C4E5199"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of subsection (a)(90), the eligibility verification requirements, beginning January 1, 2026, are as follows:</text><subparagraph id="HA25712DF69E44ECEB8F37441AC1CD8FC"><enum>(A)</enum><header>Quarterly screening to verify enrollee status</header><text display-inline="yes-display-inline">The State shall, not less frequently than quarterly, review the Death Master File (as such term is defined in section 203(d) of the Bipartisan Budget Act of 2013) to determine whether any individuals enrolled for medical assistance under the State plan (or waiver of such plan) are deceased.</text></subparagraph><subparagraph id="H03E7FB2926B34A228297FD5EAE6CB387"><enum>(B)</enum><header>Disenrollment under State plan</header><text display-inline="yes-display-inline">If the State determines, based on information obtained from the Death Master File, that an individual enrolled for medical assistance under the State plan (or waiver of such plan) is deceased, the State shall—</text><clause id="H3D780D97A60C43A9BECE9B4A0510A077"><enum>(i)</enum><text>treat such information as factual information confirming the death of a beneficiary for purposes of section 431.213(a) of title 42, Code of Federal Regulations (or any successor regulation);</text></clause><clause id="HB003418378E84747A7DA2A3ACB8A1FF8"><enum>(ii)</enum><text>disenroll such individual from the State plan (or waiver of such plan); and</text></clause><clause id="H712075840A194C57A8DF61A54B1628FD"><enum>(iii)</enum><text>discontinue any payments for medical assistance under this title made on behalf of such individual (other than payments for any items or services furnished to such individual prior to the death of such individual).</text></clause></subparagraph><subparagraph id="HC549667CCCF34579A29637724FF14E14"><enum>(C)</enum><header>Reinstatement of coverage in the event of error</header><text display-inline="yes-display-inline">If a State determines that an individual was misidentified as deceased based on information obtained from the Death Master File, and was erroneously disenrolled from medical assistance under the State plan (or waiver of such plan) based on such misidentification, the State shall immediately reenroll such individual under the State plan (or waiver of such plan), retroactive to the date of such disenrollment.</text></subparagraph></paragraph><paragraph id="HC8B5A4FFE2B647128160F3B1408FA795" commented="no" display-inline="no-display-inline"><enum>(2)</enum><header>Rule of construction</header><text display-inline="yes-display-inline">Nothing under this subsection shall be construed to preclude the ability of a State to use other electronic data sources to timely identify potentially deceased beneficiaries, so long as the State is also in compliance with the requirements of this subsection (and all other requirements under this title relating to Medicaid eligibility determination and redetermination).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="H4475FB6F73C341A88FB5583D088E3772"><enum>108.</enum><header>One-year delay of Medicaid and CHIP requirements for health screenings, referrals, and case management services for eligible juveniles in public institutions; State interim work plans</header><subsection commented="no" display-inline="no-display-inline" id="H964576E7B8F34F39A7ADE19C8427CCA7"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text>Section 5121(d) of subtitle C of title V of division FF of the Consolidated Appropriations Act, 2023 (<external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H5D20E875B8E2421583615F129CEC2004"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>The amendments made by this section</quote> and inserting the following:</text><quoted-block id="H30A0D3E6CC44477B949522395881066B" style="OLC" act-name=""><paragraph id="H4DAEB2EEA4D34E218B44CCCD5EFCC673"><enum>(1)</enum><header>In general</header><text>Subject to paragraph (2), the amendments made by this section</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEE2D284AECE14E05A22CD149BD75EB2B"><enum>(2)</enum><text>by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HA6B02BAC1B2649589CDBDA328E47A770"><paragraph commented="no" display-inline="no-display-inline" id="HECAFAADDF8BC48889DE4F1540021A3B3"><enum>(2)</enum><header>Delay of date by which States must comply with certain juvenile justice-related requirements</header><text display-inline="yes-display-inline">A State shall not be regarded as failing to comply with the requirements of section 1902(a)(84)(D) or 2102(d)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(a)(84)(D)</external-xref>, 1397bb(d)(2)) before January 1, 2026.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H59E50D7CEE4D4CCDBD34A2A2F955F0B8"><enum>(b)</enum><header>Clarifying nonapplication of requirements to individuals in Federal custody</header><paragraph commented="no" display-inline="no-display-inline" id="H48E97C7083D5499D99C512EDA5DB247C"><enum>(1)</enum><header>Medicaid</header><subparagraph commented="no" display-inline="no-display-inline" id="H65AD7882B12049EEA82D948DEA3AF7CB"><enum>(A)</enum><text display-inline="yes-display-inline">Subparagraph (D) of section 1902(a)(84) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(a)(84)</external-xref>), as added by section 5121 of subtitle C of title V of division FF of the Consolidated Appropriations Act, 2023 (<external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref>), is amended by striking <quote>an individual who is an eligible juvenile</quote> and inserting <quote>an individual (other than an individual who is in Federal custody, including as an inmate in a Federal prison) who is an eligible juvenile</quote>.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA3A4B4AD335044128A5CB6F11C2B0510"><enum>(B)</enum><text>Section 5122(a) of subtitle C of title V of division FF of the Consolidated Appropriations Act, 2023 (<external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref>) is amended—</text><clause commented="no" display-inline="no-display-inline" id="H5DA889B38C354A60937B8A65AC1145A4"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>paragraph (31)</quote> each place it appears and inserting <quote>the last numbered paragraph</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H5F015BB44FFE4DC69A751F45021E6049"><enum>(ii)</enum><text>in paragraph (1), by striking <quote>an individual who is an eligible juvenile</quote> and inserting <quote>an individual (other than an individual who is in Federal custody, including as an inmate in a Federal prison) who is an eligible juvenile</quote>.</text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HDBE59FE7879947B886357277CE44702A"><enum>(2)</enum><header>CHIP</header><subparagraph commented="no" display-inline="no-display-inline" id="H7D0E843A25D0494AB9BA1597AB1BD386"><enum>(A)</enum><text display-inline="yes-display-inline">Subsection (d)(2) of section 2102 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1397bb">42 U.S.C. 1397bb</external-xref>), as added by section 5121 of subtitle C of title V of division FF of the Consolidated Appropriations Act, 2023 (<external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref>), is amended by striking <quote>a targeted low-income child who</quote> and inserting <quote>a targeted low income child (other than a child who is in Federal custody, including as an inmate in a Federal prison) who</quote>.</text></subparagraph><subparagraph id="HDC21E0DF129F4AD59F9FBEF22A45B2D6"><enum>(B)</enum><text>Section 5122(b)(2) of subtitle C of title V of division FF of the Consolidated Appropriations Act, 2023 (<external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref>) is amended by striking <quote>a child who is</quote> and inserting <quote>a child (other than a child who is in Federal custody, including as an inmate in a Federal prison) who is</quote>.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF9BE59B8ED424856AB3E8BA4C3868BF0"><enum>(3)</enum><header display-inline="yes-display-inline">Effective date</header><text display-inline="yes-display-inline">The amendments made by this subsection shall take effect as if enacted on December 29, 2022.</text></paragraph></subsection><subsection id="HF9653643ED5143AABF8F0B8574F5811D"><enum>(c)</enum><header>Interim work plan</header><text>Not later than June 30, 2025, each State (as such term is defined in section 1101(a)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1301">42 U.S.C. 1301(a)(1)</external-xref>) for purposes of titles XIX and XXI of such Act) shall submit to the Secretary of Health and Human Services an interim work plan, in such form and containing such information as the Secretary may specify, describing the State's progress towards implementing, and its plans to come into compliance with, the requirements imposed by the amendments made by section 5121 of subtitle C of title V of division FF of the Consolidated Appropriations Act, 2023 (<external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref>), consistent with the guidance issued by the Centers for Medicare &amp; Medicaid Services in State Health Official Letter #24–004 on July 23, 2024. </text></subsection></section><section id="HD059307F14114C4C847DF42C2B5B4ABC"><enum>109.</enum><header>State studies and HHS report on costs of providing maternity, labor, and delivery services</header><subsection id="HB2B68D27353749A6A331B16CBD0BE1DD"><enum>(a)</enum><header>State study</header><paragraph id="HAA9D316ED3B144F089C704817FF045C5"><enum>(1)</enum><header>In general</header><text>Not later than 24 months after the date of enactment of this Act, and every 5 years thereafter, each State (as such term is defined in section 1101(a)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1301">42 U.S.C. 1301(a)(1)</external-xref>) for purposes of titles XIX and XXI of such Act) shall conduct a study on the costs of providing maternity, labor, and delivery services in applicable hospitals (as defined in paragraph (3)) and submit the results of such study to the Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>).</text></paragraph><paragraph id="HDBB6532F68844CE79B7461679A13C68A"><enum>(2)</enum><header>Content of study</header><text>A State study required under paragraph (1) shall include the following information (to the extent practicable) with respect to maternity, labor, and delivery services furnished by applicable hospitals located in the State:</text><subparagraph id="H320530C2632744CD832CBB5A966193F3"><enum>(A)</enum><text>An estimate of the cost of providing maternity, labor, and delivery services at applicable hospitals, based on the expenditures a representative sample of such hospitals incurred for providing such services during the 2 most recent years for which data is available.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H42D431DB48C947C7A82694360D0A1026"><enum>(B)</enum><text>An estimate of the cost of providing maternity, labor, and delivery services at applicable hospitals that ceased providing labor and delivery services within the past 5 years, based on the expenditures a representative sample of such hospitals incurred for providing such services during the 2 most recent years for which data is available.</text></subparagraph><subparagraph id="H68FB9CC5975040A0B5803DC0AA347E5B"><enum>(C)</enum><text>To the extent data allows, an analysis of the extent to which geographic location, community demographics, and local economic factors (as defined by the Secretary) affect the cost of providing maternity, labor, and delivery services at applicable hospitals, including the cost of services that support the provision of maternity, labor, and delivery services.</text></subparagraph><subparagraph id="H9A0EE8B686104DCB921CC26905A03890"><enum>(D)</enum><text>The amounts applicable hospitals are paid for maternity, labor, and delivery services, by geographic location and hospital size, under—</text><clause commented="no" display-inline="no-display-inline" id="HBF9E70647149414E9B72018BF702E6B7"><enum>(i)</enum><text display-inline="yes-display-inline">Medicare; </text></clause><clause commented="no" display-inline="no-display-inline" id="H2CA3DEA2326042E786D204E336053416"><enum>(ii)</enum><text display-inline="yes-display-inline">the State Medicaid program, including payment amounts for such services under fee-for-service payment arrangements and under managed care (as applicable);</text></clause><clause commented="no" display-inline="no-display-inline" id="H3E33C93B68A54FE5BBF3428AF846FD37"><enum>(iii)</enum><text display-inline="yes-display-inline">the State CHIP plan, including payment amounts for such services under fee-for-service payment arrangements and under managed care (as applicable); and </text></clause><clause commented="no" display-inline="no-display-inline" id="HBFE1D761EE6942EC84B7247C46ED38E8"><enum>(iv)</enum><text display-inline="yes-display-inline">private health insurance. </text></clause></subparagraph><subparagraph id="H5D65FF6149D8438F94E3CB2B5AAB693B"><enum>(E)</enum><text>A comparative payment rate analysis—</text><clause id="H1869901A0B8643B091A6A9AF38CD2B4B"><enum>(i)</enum><text>comparing payment rates for maternity, labor, and delivery services (inclusive of all payments received by applicable hospitals for furnishing maternity, labor, and delivery services) under the State Medicaid fee-for-service program to such payment rates for such services under Medicare (as described in section 447.203(b)(3) of title 42, Code of Federal Regulations), other Federally-funded or State-funded programs (including, to the extent data is available, Medicaid managed care rates), and to the payment rates for such services, to the extent data is available, of private health insurers within geographic areas of the State; and</text></clause><clause id="H5C72B8FAB8F24CC19ADD472FE16F176E"><enum>(ii)</enum><text>analyzing different payment methods for such services, such as the use of bundled payments, quality incentives, and low-volume adjustments.</text></clause></subparagraph><subparagraph id="H82154940487D4D558A2022D0E9006CBF"><enum>(F)</enum><text>An evaluation, using such methodology and parameters established by the Secretary, of whether each hospital located in the State that furnishes maternity, labor, and delivery services is expected to experience in the next 3 years significant changes in particular expenditures or types of reimbursement for maternity, labor, and delivery services.</text></subparagraph></paragraph><paragraph id="HDB9FBFE3CDAE430EAC2CF55086CB407C"><enum>(3)</enum><header>Applicable hospital defined</header><text>For purposes of this subsection, the term <term>applicable hospital</term> means any hospital located in a State that meets either of the following criteria:</text><subparagraph id="HF4C9A8FCF9FF481186637E049E9C316E"><enum>(A)</enum><text>The hospital provides labor and delivery services and more than 50 percent of the hospital’s births (in the most recent year for which such data is available) are financed by the Medicaid program or CHIP. </text></subparagraph><subparagraph id="H7ED3AAC09CC24DDE9D68D10F8F59D41C"><enum>(B)</enum><text>The hospital—</text><clause commented="no" display-inline="no-display-inline" id="H4FCD18188AC74708A62EEADDE65516FC"><enum>(i)</enum><text display-inline="yes-display-inline">is located in a rural area (as defined by the Federal Office of Rural Health Policy for the purpose of rural health grant programs administered by such Office);</text></clause><clause commented="no" display-inline="no-display-inline" id="H529A904F8BF64206A67224D81F3B4C92"><enum>(ii)</enum><text display-inline="yes-display-inline">based on the most recent 2 years of data available (as determined by the Secretary), furnished services for less than an average of 300 births per year; and</text></clause><clause commented="no" display-inline="no-display-inline" id="HB2C1751202C044E59FD9E66808DD71B3"><enum>(iii)</enum><text>provides labor and delivery services.</text></clause></subparagraph></paragraph><paragraph id="HD3AF6481B8684D8FB71E75243CB152DD" commented="no"><enum>(4)</enum><header>Assistance to small hospitals in compiling cost information</header><text>There are appropriated to the Secretary for fiscal year 2025, $10,000,000 for the purpose of providing grants and technical assistance to a hospital described in paragraph (3)(B) to enable such hospital to compile detailed information for use in the State studies required under paragraph (1), to remain available until expended.</text></paragraph><paragraph id="H122DC745B52D4E87858178074924B269"><enum>(5)</enum><header>HHS report on State studies</header><text>For each year in which a State is required to conduct a study under paragraph (1), the Secretary shall issue, not later than 12 months after the date on which the State submits to the Secretary the data described in such paragraph, a publicly available report that compiles and details the results of such study and includes the information described in paragraph (2).</text></paragraph></subsection><subsection id="H24248E9D9B024D878679146C180E85CD"><enum>(b)</enum><header>HHS report on national data collection findings</header><text>Not later than 3 years after the date of enactment of this Act, the Secretary shall submit to Congress, and make publicly available, a report analyzing the first studies conducted by States under subsection (a)(1), including recommendations for improving data collection on the cost of providing maternity, labor, and delivery services. </text></subsection><subsection commented="no" display-inline="no-display-inline" id="H90026A95B5C04DE999AE38EDE97F4A5C"><enum>(c)</enum><header>Implementation funding</header><text>In addition to the amount appropriated under subsection (a)(4), there are appropriated, out of any funds in the Treasury not otherwise obligated, $3,000,000 for fiscal year 2025, to remain available until expended, to the Secretary of Health and Human Services for purposes of implementing this section.</text></subsection></section><section id="HAD4FFB35D0194180B25838D9C3BAF8B3"><enum>110.</enum><header>Modifying certain disproportionate share hospital allotments</header><subsection commented="no" display-inline="no-display-inline" id="H031A7C9E268C4E7286AD2437331176F0"><enum>(a)</enum><header display-inline="yes-display-inline">Extending Tennessee DSH allotments</header><text display-inline="yes-display-inline">Section 1923(f)(6)(A)(vi) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-4">42 U.S.C. 1396r–4(f)(6)(A)(vi)</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="HFDFB216B645649E692736E92DD88E181"><enum>(1)</enum><text display-inline="yes-display-inline">in the heading, by striking <quote><header-in-text style="OLC" level="clause">2025</header-in-text></quote> and inserting <quote><header-in-text style="OLC" level="clause">2026 and for the 1st quarter of fiscal year 2027</header-in-text></quote>; </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H024AA53104374A64B2387F886FD5F761"><enum>(2)</enum><text display-inline="yes-display-inline">by striking <quote>fiscal year 2025</quote> and inserting <quote>fiscal year 2026</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H94C7137ED851452586B98CD39D6ABA9D"><enum>(3)</enum><text>by inserting <quote>, and the DSH allotment for Tennessee for the 1st quarter of fiscal year 2027, shall be $13,275,000</quote> before the period.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H138A6935DAD042389EDD3D6382866986"><enum>(b)</enum><header>Eliminating and delaying DSH allotment reductions</header><text>Section 1923(f) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-4">42 U.S.C. 1396r–4(f)</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="HF2E78E20DF244BC7B40FFBEC7549A584"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (7)(A)—</text><subparagraph commented="no" display-inline="no-display-inline" id="H2ABF0608BBAD46FF86AACD3636108331"><enum>(A)</enum><text>in clause (i), in the matter preceding subclause (I), by striking <quote>April 1, 2025,</quote> and all that follows through <quote>2027</quote> and inserting <quote>January 1, 2027, and ending September 30, 2027, and for fiscal year 2028</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5BE9DDBBAC8E410F840FC73028C549BC"><enum>(B)</enum><text>in clause (ii), by striking <quote>April 1, 2025, </quote> and all that follows through <quote>2027</quote> and inserting <quote>January 1, 2027, and ending September 30, 2027, and for fiscal year 2028</quote>; and</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H79E1323B086948EF9AAADDAA831DB5CB"><enum>(2)</enum><text>in paragraph (8), by striking <quote>2027</quote> and inserting <quote>2028</quote>. </text></paragraph></subsection></section><section id="HB338874B817C469BA85072097B0D2E5F"><enum>111.</enum><header>Modifying certain limitations on disproportionate share hospital payment adjustments under the Medicaid program</header><subsection id="HB7835978C76644858ABDCC1F01CC98C9"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1923(g) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-4">42 U.S.C. 1396r–4(g)</external-xref>) is amended—</text><paragraph id="HFAE82D374CDF4FE7BBE88D3C110D1DE9"><enum>(1)</enum><text>in paragraph (1)—</text><subparagraph id="HCB1149A1740F4057B9B2E0B2512CE4A6"><enum>(A)</enum><text>in subparagraph (A)—</text><clause id="H51BC7514FE984BD2B6D4587A3D342F4B"><enum>(i)</enum><text>in the matter preceding clause (i), by striking <quote>(other than a hospital described in paragraph (2)(B))</quote>;</text></clause><clause id="H213154286FE5461EB725C1D015244358"><enum>(ii)</enum><text>in clause (i), by inserting <quote>with respect to such hospital and year</quote> after <quote>described in subparagraph (B)</quote>; and </text></clause><clause id="H0D351D8FC92849938810C00CDEA0539C"><enum>(iii)</enum><text>in clause (ii)—</text><subclause id="H859D117212254A7FB40B6BF1FCE95C6E"><enum>(I)</enum><text>in subclause (I), by striking <quote>and</quote> at the end;</text></subclause><subclause id="H561BD4E9B9734B3F8D28EE0C184F627B"><enum>(II)</enum><text>in subclause (II), by striking the period and inserting <quote>; and</quote>; and</text></subclause><subclause id="H2B10C8BE7FAF4B4AA5833B45B8479597"><enum>(III)</enum><text>by adding at the end the following new subclause:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HFE194550D0A34D6BB1C7E01EFD94DC8F"><subclause id="HA8EB749ED4354FE9BAB909E05AA83594"><enum>(III)</enum><text display-inline="yes-display-inline">payments made under title XVIII or by an applicable plan (as defined in section 1862(b)(8)(F)) for such services.</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subclause></clause></subparagraph><subparagraph id="HCBDE40A8A3134347A89EDD86AB49236A"><enum>(B)</enum><text>in subparagraph (B)—</text><clause id="HE650648D5C444E82A871078FBC541854"><enum>(i)</enum><text>in the matter preceding clause (i), by striking <quote>in this clause are</quote> and inserting <quote>in this subparagraph are, with respect to a hospital and a year,</quote>; and</text></clause><clause id="HF37643D6D47B4AFEBD3926D86FB2FF74"><enum>(ii)</enum><text>by adding at the end the following new clause:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HA7C09B1354DE442BA069F53A4A4051A7"><clause id="H325F0F8AAA0148B484A6C872CB745BD2"><enum>(iii)</enum><text display-inline="yes-display-inline">Individuals who are eligible for medical assistance under the State plan or under a waiver of such plan and for whom the State plan or waiver is a payor for such services after application of benefits under title XVIII or under an applicable plan (as defined in section 1862(b)(8)(F)), but only if the hospital has in the aggregate incurred costs exceeding payments under such State plan, waiver, title XVIII, or applicable plan for such services furnished to such individuals during such year.</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph></paragraph><paragraph id="H74BBBB7D604942DB8692B99B3742C860"><enum>(2)</enum><text>by striking paragraph (2);</text></paragraph><paragraph id="H9BCA004C25074295A5A68F66561ADFC0"><enum>(3)</enum><text>by redesignating paragraph (3) as paragraph (2); and</text></paragraph><paragraph id="H3CFEC34E83074321848BEBBC40985525"><enum>(4)</enum><text>in paragraph (2), as so redesignated, by striking <quote>Notwithstanding paragraph (2) of this subsection (as in effect on October 1, 2021), paragraph (2)</quote> and inserting <quote>Paragraph (2)</quote>.</text></paragraph></subsection><subsection id="H77F3F091D9174661BBAFAFAE0F3C321D"><enum>(b)</enum><header>Effective date</header><paragraph commented="no" display-inline="no-display-inline" id="H1981CBE1CE4A4987AF3CB3CAEAF19688"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text>Except as provided in paragraph (2), the amendments made by this section shall apply to payment adjustments made under section 1923 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-4">42 U.S.C. 1396r–4</external-xref>) for Medicaid State plan rate years beginning on or after the date of enactment of this Act.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6AC426A2943D4A75A6B7DAB439892C93"><enum>(2)</enum><header>State option to distribute unspent DSH allotments from prior years up to modified cap</header><subparagraph commented="no" display-inline="no-display-inline" id="HAA6106720F574EE6A2206E1B2E57FF13"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">If, for any Medicaid State plan rate year that begins on or after October 1, 2021, and before the date of enactment of this Act, a State did not spend the full amount of its Federal fiscal year allotment under section 1923 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-4">42 U.S.C. 1396r–4</external-xref>) applicable to that State plan rate year, the State may use the unspent portion of such allotment to increase the amount of any payment adjustment made to a hospital for such rate year, provided that— </text><clause commented="no" display-inline="no-display-inline" id="H9B9E39EF4278444F8263E292F721C6C6"><enum>(i)</enum><text display-inline="yes-display-inline">such payment adjustment (as so increased) is consistent with subsection (g) of such section (as amended by this section); and</text></clause><clause commented="no" display-inline="no-display-inline" id="H399ECDDB3F4C4FAAACCEFADCAB14B97F"><enum>(ii)</enum><text>the total amount of all payment adjustments for the State plan rate year (as so increased) does not exceed the disproportionate share hospital allotment for the State and applicable Federal fiscal year under subsection (f) of such section.</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HD16AB3BCE85044179D947D72ECBFE3B4"><enum>(B)</enum><header>No recoupment of payments already made to hospitals</header><text>A State shall not recoup any payment adjustment made by the State to a hospital for a Medicaid State plan rate year described in subparagraph (A) if such payment adjustment is consistent with section 1923(g) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-4">42 U.S.C. 1396r–4(g)</external-xref>) as in effect on October 1, 2021.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7B0B1DD378474E1ABC8150F00ACDA0AE"><enum>(C)</enum><header>Authority to permit retroactive modification of State plan amendments to allow for increases</header><clause commented="no" display-inline="no-display-inline" id="HB5119E1CFBBC46DF9481D9FB077524C1"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">Subject to paragraph (2), solely for the purpose of allowing a State to increase the amount of a payment adjustment to a hospital for a Medicaid State plan rate year described in subparagraph (A) pursuant to this paragraph, a State may retroactively modify a provision of the Medicaid State plan, a waiver of such plan, or a State plan amendment that relates to such rate year and the Secretary may approve such modification.</text></clause><clause commented="no" display-inline="no-display-inline" id="HCECB794E1A424845952A057FE2CA18B0"><enum>(ii)</enum><header>Deadline</header><text>A State may not submit a request for approval of a retroactive modification to a provision of the Medicaid State plan, a waiver of such plan, or a State plan amendment for a Medicaid State plan rate year after the date by which the State is required to submit the independent certified audit for that State plan rate year as required under section 1923(j)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-4">42 U.S.C. 1396r–4(j)(2)</external-xref>).</text></clause></subparagraph><subparagraph id="H99CE25CE4E2F4963A3B9E1A428A3904D" commented="no" display-inline="no-display-inline"><enum>(D)</enum><header display-inline="yes-display-inline">Reporting</header><text>If a State increases a payment adjustment made to a hospital for a Medicaid State plan rate year pursuant to this paragraph, the State shall include information on such increased payment adjustment as part of the next annual report submitted by the State under section 1923(j)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-4">42 U.S.C. 1396r–4(j)(1)</external-xref>). </text></subparagraph></paragraph></subsection></section><section id="HF5DC0E3F7E2B4EF683B75CEF41E4AF3A"><enum>112.</enum><header>Ensuring accurate payments to pharmacies under Medicaid</header><subsection id="H9577DAE11BA74237BC68CDF259E09DE1"><enum>(a)</enum><header>In general</header><text>Section 1927(f) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(f)</external-xref>) is amended—</text><paragraph id="H50DBC9A229F64315ABAD86580DFBE752"><enum>(1)</enum><text>in paragraph (1)(A)—</text><subparagraph commented="no" display-inline="no-display-inline" id="HD3283A138D29460BB16FD2B70ADEC7CA"><enum>(A)</enum><text display-inline="yes-display-inline">by redesignating clause (ii) as clause (iii); and</text></subparagraph><subparagraph id="HE38D2B95FB2D4FD084D7DCFBCCB614F0"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>and</quote> after the semicolon at the end of clause (i) and all that precedes it through <quote>(1)</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H95D71092EEB74B62A96B6ED30EEE8DAC"><paragraph id="HBBEE0BC922DE41C49BC70C4D7887638F"><enum>(1)</enum><header>Determining pharmacy actual acquisition costs</header><text>The Secretary shall conduct a survey of retail community pharmacy drug prices and applicable non-retail pharmacy drug prices to determine national average drug acquisition cost benchmarks (as such term is defined by the Secretary) as follows:</text><subparagraph commented="no" display-inline="no-display-inline" id="H873E3581F534435986545B9648674200"><enum>(A)</enum><header display-inline="yes-display-inline">Use of vendor</header><text display-inline="yes-display-inline">The Secretary may contract services for—</text><clause commented="no" display-inline="no-display-inline" id="HC6F9C4249C1A43EC8A8FFC8D1583C0A2"><enum>(i)</enum><text>with respect to retail community pharmacies, the determination of retail survey prices of the national average drug acquisition cost for covered outpatient drugs that represent a nationwide average of consumer purchase prices for such drugs, net of all discounts, rebates, and other price concessions (to the extent any information with respect to such discounts, rebates, and other price concessions is available) based on a monthly survey of such pharmacies; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H2CB06FC7E43F4D0D94ADE97B3C969D5F"><enum>(ii)</enum><text>with respect to applicable non-retail pharmacies— </text><subclause commented="no" display-inline="no-display-inline" id="H9328AA7EF8AA427180DECB6BA1EA1CB9"><enum>(I)</enum><text display-inline="yes-display-inline">the determination of survey prices, separate from the survey prices described in clause (i), of the non-retail national average drug acquisition cost for covered outpatient drugs that represent a nationwide average of consumer purchase prices for such drugs, net of all discounts, rebates, and other price concessions (to the extent any information with respect to such discounts, rebates, and other price concessions is available) based on a monthly survey of such pharmacies; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H43D751E331834D36827B0450829E4124"><enum>(II)</enum><text display-inline="yes-display-inline">at the discretion of the Secretary, for each type of applicable non-retail pharmacy, the determination of survey prices, separate from the survey prices described in clause (i) or subclause (I) of this clause, of the national average drug acquisition cost for such type of pharmacy for covered outpatient drugs that represent a nationwide average of consumer purchase prices for such drugs, net of all discounts, rebates, and other price concessions (to the extent any information with respect to such discounts, rebates, and other price concessions is available) based on a monthly survey of such pharmacies; and</text></subclause></clause></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H562C8387FF264D14B36EDCB150FDD2E5"><enum>(2)</enum><text>in subparagraph (B) of paragraph (1), by striking <quote>subparagraph (A)(ii)</quote> and inserting <quote>subparagraph (A)(iii)</quote>;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6416E1E9A64C4EDA9FF330755E2CA12D"><enum>(3)</enum><text display-inline="yes-display-inline">in subparagraph (D) of paragraph (1), by striking clauses (ii) and (iii) and inserting the following: </text><quoted-block style="OLC" display-inline="no-display-inline" id="HFB27E1E3B2A041EE8BE52F9211DFBE42"><clause id="HE4B60E713583400E80EDE70F85AABCE3"><enum>(ii)</enum><text>The vendor must update the Secretary no less often than monthly on the survey prices for covered outpatient drugs.</text></clause><clause id="HBC9F76F9AA2D4AC2BA5401D6D42E15EC"><enum>(iii)</enum><text display-inline="yes-display-inline">The vendor must differentiate, in collecting and reporting survey data, for all cost information collected, whether a pharmacy is a retail community pharmacy or an applicable non-retail pharmacy, including whether such pharmacy is an affiliate (as defined in subsection (k)(14)), and, in the case of an applicable non-retail pharmacy, which type of applicable non-retail pharmacy it is using the relevant pharmacy type indicators included in the guidance required by subsection (d)(2) of section 112 of the Health Improvements, Extenders, and Reauthorizations Act.</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFB0BCB8DA2EB4DDAB6BD3A0A9FD41D1A"><enum>(4)</enum><text display-inline="yes-display-inline">by adding at the end of paragraph (1) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HD386E7EFFB534EB88A49F2969016A172"><subparagraph id="H34134B079CFA48088916AA1E73411E7C"><enum>(F)</enum><header>Survey reporting</header><text display-inline="yes-display-inline">In order to meet the requirement of section 1902(a)(54), a State shall require that any retail community pharmacy or applicable non-retail pharmacy in the State that receives any payment, reimbursement, administrative fee, discount, rebate, or other price concession related to the dispensing of covered outpatient drugs to individuals receiving benefits under this title, regardless of whether such payment, reimbursement, administrative fee, discount, rebate, or other price concession is received from the State or a managed care entity or other specified entity (as such terms are defined in section 1903(m)(9)(D)) directly or from a pharmacy benefit manager or another entity that has a contract with the State or a managed care entity or other specified entity (as so defined), shall respond to surveys conducted under this paragraph.</text></subparagraph><subparagraph id="H75EA77F098B34427AD56F40F3C6D8C51"><enum>(G)</enum><header>Survey information</header><text>Information on national drug acquisition prices obtained under this paragraph shall be made publicly available in a form and manner to be determined by the Secretary and shall include at least the following:</text><clause id="H5CD07CA51ECF477A851523F95510145B"><enum>(i)</enum><text>The monthly response rate to the survey including a list of pharmacies not in compliance with subparagraph (F).</text></clause><clause id="H67DAF886C79C4085947586AA9EF0A9E0"><enum>(ii)</enum><text>The sampling methodology and number of pharmacies sampled monthly.</text></clause><clause id="HFE12AE9EE7C849BDB0ED52C0DAE8028F"><enum>(iii)</enum><text>Information on price concessions to pharmacies, including discounts, rebates, and other price concessions, to the extent that such information may be publicly released and has been collected by the Secretary as part of the survey.</text></clause></subparagraph><subparagraph id="H61500C4579934389B10D545D32DFFC5B"><enum>(H)</enum><header>Penalties</header><clause commented="no" display-inline="no-display-inline" id="H7076CF8F6847467ABFE91CE2BA1AAFF7"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">Subject to clauses (ii), (iii), and (iv), the Secretary shall enforce the provisions of this paragraph with respect to a pharmacy through the establishment of civil money penalties applicable to a retail community pharmacy or an applicable non-retail pharmacy.</text></clause><clause commented="no" display-inline="no-display-inline" id="H7EB53357D09746D6B2926557CE59CBA7"><enum>(ii)</enum><header>Basis for penalties</header><text display-inline="yes-display-inline">The Secretary shall impose a civil money penalty established under this subparagraph on a retail community pharmacy or applicable non-retail pharmacy if—</text><subclause commented="no" display-inline="no-display-inline" id="H001E9F613EA343DBB49DF69D1CA2FBDB"><enum>(I)</enum><text display-inline="yes-display-inline">the retail pharmacy or applicable non-retail pharmacy refuses or otherwise fails to respond to a request for information about prices in connection with a survey under this subsection; </text></subclause><subclause commented="no" display-inline="no-display-inline" id="H150F9E872E4049E3902FAD928C964FFB"><enum>(II)</enum><text display-inline="yes-display-inline">knowingly provides false information in response to such a survey; or</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H27FD4840D8764706AD6C3BF47EBCC1E6"><enum>(III)</enum><text>otherwise fails to comply with the requirements established under this paragraph.</text></subclause></clause><clause commented="no" display-inline="no-display-inline" id="HECB9DAA448D849FAB4C96AE5F47D95C2"><enum>(iii)</enum><header>Parameters for penalties</header><subclause commented="no" display-inline="no-display-inline" id="H207733212841456E82BD521C3EBA5127"><enum>(I)</enum><header display-inline="yes-display-inline">In general</header><text>A civil money penalty established under this subparagraph may be assessed with respect to each violation, and with respect to each non-compliant retail community pharmacy (including a pharmacy that is part of a chain) or non-compliant applicable non-retail pharmacy (including a pharmacy that is part of a chain), in an amount not to exceed $100,000 for each such violation.</text></subclause><subclause id="H3551BF764266413B83D86CA64C356D45"><enum>(II)</enum><header>Considerations</header><text>In determining the amount of a civil money penalty imposed under this subparagraph, the Secretary may consider the size, business structure, and type of pharmacy involved, as well as the type of violation and other relevant factors, as determined appropriate by the Secretary. </text></subclause></clause><clause commented="no" display-inline="no-display-inline" id="HA687BBA42E0C4F35B9187FED8D06ED9A"><enum>(iv)</enum><header>Rule of application</header><text display-inline="yes-display-inline">The provisions of section 1128A (other than subsections (a) and (b)) shall apply to a civil money penalty under this subparagraph in the same manner as such provisions apply to a civil money penalty or proceeding under section 1128A(a). </text></clause></subparagraph><subparagraph id="H1AFC4EC8A7F845CB93CFE227A859B0CB"><enum>(I)</enum><header>Limitation on use of applicable non-retail pharmacy pricing information</header><text>No State shall use pricing information reported by applicable non-retail pharmacies under subparagraph (A)(ii) to develop or inform payment methodologies for retail community pharmacies.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></paragraph><paragraph id="H498DDFC87EC84A3DA0CD2CB1A364D413"><enum>(5)</enum><text>in paragraph (2)—</text><subparagraph id="H3EDFB52126444D98A67983D40F1C5178"><enum>(A)</enum><text>in subparagraph (A), by inserting <quote>, including payment rates and methodologies for determining ingredient cost reimbursement under managed care entities or other specified entities (as such terms are defined in section 1903(m)(9)(D)),</quote> after <quote>under this title</quote>; and</text></subparagraph><subparagraph id="H688B735C9770439B8C64615569E87996"><enum>(B)</enum><text>in subparagraph (B), by inserting <quote>and the basis for such dispensing fees</quote> before the semicolon; </text></subparagraph></paragraph><paragraph id="H43CD967C570D46858B50E4787ADD762F"><enum>(6)</enum><text>by redesignating paragraph (4) as paragraph (5);</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H843A8B49D5F44811849DC3C6970630EA"><enum>(7)</enum><text display-inline="yes-display-inline">by inserting after paragraph (3) the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HFE92075BC0A34F49ADEB6967A9877094"><paragraph id="H150E3C87C3CE457E9CFB040E0D75CD73"><enum>(4)</enum><header>Oversight</header><subparagraph commented="no" display-inline="no-display-inline" id="H4A13DE4DFFF54D66AD377409BCBDC437"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The Inspector General of the Department of Health and Human Services shall conduct periodic studies of the survey data reported under this subsection, as appropriate, including with respect to substantial variations in acquisition costs or other applicable costs, as well as with respect to how internal transfer prices and related party transactions may influence the costs reported by pharmacies that are affiliates (as defined in subsection (k)(14)) or are owned by, controlled by, or related under a common ownership structure with a wholesaler, distributor, or other entity that acquires covered outpatient drugs relative to costs reported by pharmacies not affiliated with such entities. The Inspector General shall provide periodic updates to Congress on the results of such studies, as appropriate, in a manner that does not disclose trade secrets or other proprietary information.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF016B364E54143D38D73F17945B0668F"><enum>(B)</enum><header>Appropriation</header><text display-inline="yes-display-inline">There is appropriated to the Inspector General of the Department of Health and Human Services, out of any money in the Treasury not otherwise appropriated, $5,000,000 for fiscal year 2025, to remain available until expended, to carry out this paragraph.</text></subparagraph></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF65B147946A3486B82E4FD76D3080D4B"><enum>(8)</enum><text display-inline="yes-display-inline">in paragraph (5), as so redesignated— </text><subparagraph commented="no" display-inline="no-display-inline" id="HF4C4B11E95E54BEA822F04BC1253DA42"><enum>(A)</enum><text display-inline="yes-display-inline">by inserting <quote>, and $9,000,000 for fiscal year 2025 and each fiscal year thereafter,</quote> after <quote>2010</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7CB20072568B4E0389E5A1B962C1D369"><enum>(B)</enum><text>by inserting <quote>Funds appropriated under this paragraph for fiscal year 2025 and any subsequent fiscal year shall remain available until expended.</quote> after the period.</text></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HE121511C16EE4401B3F8858DA9B4D555"><enum>(b)</enum><header>Definitions</header><text display-inline="yes-display-inline">Section 1927(k) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(k)</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H5B7EAACC6A3E4BDF9D1965A4B92ED397"><enum>(1)</enum><text display-inline="yes-display-inline">in the matter preceding paragraph (1), by striking <quote>In the section</quote> and inserting <quote>In this section</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2CC0DC4740664637B47964F298839CCB"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following new paragraphs:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H54C3248C08204E28966F3A021918AD01"><paragraph id="H8436B2002F65401DAB60A3428B9F4168"><enum>(12)</enum><header>Applicable non-retail pharmacy</header><text display-inline="yes-display-inline">The term <term>applicable non-retail pharmacy</term> means a pharmacy that is licensed as a pharmacy by the State and that is not a retail community pharmacy, including a pharmacy that dispenses prescription medications to patients primarily through mail and specialty pharmacies. Such term does not include nursing home pharmacies, long-term care facility pharmacies, hospital pharmacies, clinics, charitable or not-for-profit pharmacies, government pharmacies, or low dispensing pharmacies (as defined by the Secretary).</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0F0802C799C44BB397FCECB82922BB84"><enum>(13)</enum><header>Affiliate</header><text display-inline="yes-display-inline">The term <term>affiliate</term> means any entity that is owned by, controlled by, or related under a common ownership structure with a pharmacy benefit manager or a managed care entity or other specified entity (as such terms are defined in section 1903(m)(9)(D)).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H5480880334F94D0F83009BEE691212B1"><enum>(c)</enum><header display-inline="yes-display-inline">Effective date</header><paragraph commented="no" display-inline="no-display-inline" id="H575A63D6DE814E38B5EF5D8B1710A37D"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Subject to paragraph (2), the amendments made by this section shall take effect on the first day of the first quarter that begins on or after the date that is 6 months after the date of enactment of this Act.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H49F9689260D243ACA3D3FC5C7BB9BB52"><enum>(2)</enum><header>Delayed application to applicable non-retail pharmacies</header><text>The pharmacy survey requirements established by the amendments to section 1927(f) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(f)</external-xref>) made by this section shall apply to retail community pharmacies beginning on the effective date described in paragraph (1), but shall not apply to applicable non-retail pharmacies until the first day of the first quarter that begins on or after the date that is 18 months after the date of enactment of this Act.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HDA68A8CFA82E45AD8346F61E27C3042B"><enum>(d)</enum><header>Identification of applicable non-Retail pharmacies</header><paragraph commented="no" display-inline="no-display-inline" id="HF691F43090714CB698C6A25B9BB08035"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than January 1, 2026, the Secretary of Health and Human Services shall, in consultation with stakeholders as appropriate, publish guidance specifying pharmacies that meet the definition of applicable non-retail pharmacies (as such term is defined in subsection (k)(12) of section 1927 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8</external-xref>), as added by subsection (b)), and that will be subject to the survey requirements under subsection (f)(1) of such section, as amended by subsection (a).</text></paragraph><paragraph id="H580A938EF79A40AC8262086B9CA3C2D8"><enum>(2)</enum><header>Inclusion of pharmacy type indicators</header><text>The guidance published under paragraph (1) shall include pharmacy type indicators to distinguish between different types of applicable non-retail pharmacies, such as pharmacies that dispense prescriptions primarily through the mail and pharmacies that dispense prescriptions that require special handling or distribution. An applicable non-retail pharmacy may be identified through multiple pharmacy type indicators. </text></paragraph></subsection><subsection id="HE63FF41B37EA4615BC2167B0539F7EBD"><enum>(e)</enum><header>Implementation</header><paragraph commented="no" display-inline="no-display-inline" id="H036CC7C341DB4C7B90E7EC019AC5AEE3"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by this section by program instruction or otherwise.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H463E0123EFDD4903941F1CDAB4E70F83"><enum>(2)</enum><header>Nonapplication of Administrative Procedure Act</header><text>Implementation of the amendments made by this section shall be exempt from the requirements of section 553 of title 5, United States Code. </text></paragraph></subsection><subsection id="HBB3119F18CC244CC9A176CD6027E8841" commented="no" display-inline="no-display-inline"><enum>(f)</enum><header>Nonapplication of paperwork reduction act</header><text><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/44/35">Chapter 35</external-xref> of title 44, United States Code, shall not apply to any data collection undertaken by the Secretary of Health and Human Services under section 1927(f) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(f)</external-xref>), as amended by this section. </text></subsection></section><section id="H68D16CA7A1C3454DAB3B9E85C02A786E"><enum>113.</enum><header>Preventing the use of abusive spread pricing in Medicaid</header><subsection id="H82A8F6D9CAD8471F8229F786CA4CDD98"><enum>(a)</enum><header>In general</header><text>Section 1927 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8</external-xref>) is amended—</text><paragraph id="H2B93AB0FD319405F988E7B16B1185414"><enum>(1)</enum><text>in subsection (e), by adding at the end the following new paragraph:</text><quoted-block id="H1427CCD94C564619ACF717F136A9A784" style="OLC"><paragraph id="HFBC927D5D9374F9E994E447E818C1212"><enum>(6)</enum><header>Transparent prescription drug pass-through pricing required</header><subparagraph id="HA2B7BAC27EF640D48BF58835FA198052"><enum>(A)</enum><header>In general</header><text>A contract between the State and a pharmacy benefit manager (referred to in this paragraph as a <quote>PBM</quote>), or a contract between the State and a managed care entity or other specified entity (as such terms are defined in section 1903(m)(9)(D) and collectively referred to in this paragraph as the <quote>entity</quote>) that includes provisions making the entity responsible for coverage of covered outpatient drugs dispensed to individuals enrolled with the entity, shall require that payment for such drugs and related administrative services (as applicable), including payments made by a PBM on behalf of the State or entity, is based on a transparent prescription drug pass-through pricing model under which—</text><clause id="H36D2CD15F1B242879D9B65CB5DB99BB1"><enum>(i)</enum><text>any payment made by the entity or the PBM (as applicable) for such a drug—</text><subclause id="H1DB39C145B714EA3865E7BAD4C27C4AB"><enum>(I)</enum><text>is limited to—</text><item id="HE966767735A44D8090804A580C3BD000"><enum>(aa)</enum><text>ingredient cost; and</text></item><item id="HE4D2A11EE2424BBB86F6C17F2558F834"><enum>(bb)</enum><text>a professional dispensing fee that is not less than the professional dispensing fee that the State would pay if the State were making the payment directly in accordance with the State plan;</text></item></subclause><subclause id="H9C5CB9BB55C441C0A5BEAC08EE4D756E"><enum>(II)</enum><text>is passed through in its entirety (except as reduced under Federal or State laws and regulations in response to instances of waste, fraud, or abuse) by the entity or PBM to the pharmacy or provider that dispenses the drug; and</text></subclause><subclause id="H911861E165C7471EABE99723FBDE4CFD"><enum>(III)</enum><text>is made in a manner that is consistent with sections 447.502, 447.512, 447.514, and 447.518 of title 42, Code of Federal Regulations (or any successor regulation) as if such requirements applied directly to the entity or the PBM, except that any payment by the entity or the PBM for the ingredient cost of such drug purchased by a covered entity (as defined in subsection (a)(5)(B)) may exceed the actual acquisition cost (as defined in 447.502 of title 42, Code of Federal Regulations, or any successor regulation) for such drug if—</text><item id="H97E8CC73011F44ECB380A03ED00EB730"><enum>(aa)</enum><text>such drug was subject to an agreement under section 340B of the Public Health Service Act;</text></item><item id="HF137FEEA6AA74E499A0EF4CE36464E89"><enum>(bb)</enum><text>such payment for the ingredient cost of such drug does not exceed the maximum payment that would have been made by the entity or the PBM for the ingredient cost of such drug if such drug had not been purchased by such covered entity; and</text></item><item id="H4A7AFB5E8BE14089840A3F34717E6074"><enum>(cc)</enum><text>such covered entity reports to the Secretary (in a form and manner specified by the Secretary), on an annual basis and with respect to payments for the ingredient costs of such drugs so purchased by such covered entity that are in excess of the actual acquisition costs for such drugs, the aggregate amount of such excess;</text></item></subclause></clause><clause id="H16BA20535A9441DEBACA52ECE7716F88"><enum>(ii)</enum><text>payment to the entity or the PBM (as applicable) for administrative services performed by the entity or PBM is limited to an administrative fee that reflects the fair market value (as defined by the Secretary) of such services;</text></clause><clause id="HB8292B0BA4B748439B9B6535A9F50CDA" commented="no"><enum>(iii)</enum><text>the entity or the PBM (as applicable) makes available to the State, and the Secretary upon request in a form and manner specified by the Secretary, all costs and payments related to covered outpatient drugs and accompanying administrative services (as described in clause (ii)) incurred, received, or made by the entity or the PBM, broken down (as specified by the Secretary), to the extent such costs and payments are attributable to an individual covered outpatient drug, by each such drug, including any ingredient costs, professional dispensing fees, administrative fees (as described in clause (ii)), post-sale and post-invoice fees, discounts, or related adjustments such as direct and indirect remuneration fees, and any and all other remuneration, as defined by the Secretary; and</text></clause><clause id="HC1A236B9397345F5864C33D274A9741D"><enum>(iv)</enum><text>any form of spread pricing whereby any amount charged or claimed by the entity or the PBM (as applicable) that exceeds the amount paid to the pharmacies or providers on behalf of the State or entity, including any post-sale or post-invoice fees, discounts, or related adjustments such as direct and indirect remuneration fees or assessments, as defined by the Secretary, (after allowing for an administrative fee as described in clause (ii)) is not allowable for purposes of claiming Federal matching payments under this title.</text></clause></subparagraph><subparagraph id="H83865173D62249BBB65BED7590A93421"><enum>(B)</enum><header>Publication of information</header><text>The Secretary shall publish, not less frequently than on an annual basis and in a manner that does not disclose the identity of a particular covered entity or organization, information received by the Secretary pursuant to subparagraph (A)(i)(III)(cc) that is broken out by State and by each of the following categories of covered entity within each such State:</text><clause id="HA1CA732DD6744D398025F364F90AC630"><enum>(i)</enum><text>Covered entities described in subparagraph (A) of section 340B(a)(4) of the Public Health Service Act.</text></clause><clause id="H16D4457372EC4284A53D4AF9D446A7F6"><enum>(ii)</enum><text>Covered entities described in subparagraphs (B) through (K) of such section.</text></clause><clause id="H623E62DED7684EC9982332F8893E66B2"><enum>(iii)</enum><text>Covered entities described in subparagraph (L) of such section.</text></clause><clause id="H1A31D53F247F4C41837974320FC26562"><enum>(iv)</enum><text>Covered entities described in subparagraph (M) of such section.</text></clause><clause id="H355DCD073CFF4BB7B52A1CA2F2A03168"><enum>(v)</enum><text>Covered entities described in subparagraph (N) of such section.</text></clause><clause id="H5ABB59BF764048019474036F844ADC5F"><enum>(vi)</enum><text>Covered entities described in subparagraph (O) of such section.</text></clause></subparagraph></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="H9097A214DC624E2BB0481DEF8B57463B"><enum>(2)</enum><text>in subsection (k), as previously amended by this title, by adding at the end the following new paragraph:</text><quoted-block style="OLC" id="HADFB27D63E42432C995D04661486EF83" display-inline="no-display-inline"><paragraph id="H10C3759B4B4542FCB45700E1D4402CCA"><enum>(14)</enum><header>Pharmacy benefit manager</header><text display-inline="yes-display-inline">The term <term>pharmacy benefit manager</term> means any person or entity that, either directly or through an intermediary, acts as a price negotiator or group purchaser on behalf of a State, managed care entity (as defined in section 1903(m)(9)(D)), or other specified entity (as so defined), or manages the prescription drug benefits provided by a State, managed care entity, or other specified entity, including the processing and payment of claims for prescription drugs, the performance of drug utilization review, the processing of drug prior authorization requests, the managing of appeals or grievances related to the prescription drug benefits, contracting with pharmacies, controlling the cost of covered outpatient drugs, or the provision of services related thereto. Such term includes any person or entity that acts as a price negotiator (with regard to payment amounts to pharmacies and providers for a covered outpatient drug or the net cost of the drug) or group purchaser on behalf of a State, managed care entity, or other specified entity or that carries out 1 or more of the other activities described in the preceding sentence, irrespective of whether such person or entity calls itself a pharmacy benefit manager. </text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H69542177A80F4E5B99B6B98D5AD9C17D"><enum>(b)</enum><header>Conforming amendments</header><text>Section 1903(m) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396b">42 U.S.C. 1396b(m)</external-xref>) is amended—</text><paragraph id="H08E06A13B47D40E9B15391D621DCDC2B"><enum>(1)</enum><text>in paragraph (2)(A)(xiii)—</text><subparagraph id="HC912D1233EB3409392BBAD2A60611D6E"><enum>(A)</enum><text>by striking <quote>and (III)</quote> and inserting <quote>(III)</quote>;</text></subparagraph><subparagraph id="HB7A27364F2B240B5B281A05A1C26017E"><enum>(B)</enum><text>by inserting before the period at the end the following: <quote>, and (IV) if the contract includes provisions making the entity responsible for coverage of covered outpatient drugs, the entity shall comply with the requirements of section 1927(e)(6)</quote>; and</text></subparagraph><subparagraph id="H408CBDEA52314C4884C59E1E8A1B08DC"><enum>(C)</enum><text>by moving the margin 2 ems to the left; and</text></subparagraph></paragraph><paragraph id="HEBA6AC21A16A4D75AACF42EFE58314AB"><enum>(2)</enum><text>by adding at the end the following new paragraph:</text><quoted-block id="HEEF9F920ABF449C2BCA5D99C643A9A9C" style="OLC"><paragraph id="H9B09555BAB114904871C285D202B45D2"><enum>(10)</enum><text>No payment shall be made under this title to a State with respect to expenditures incurred by the State for payment for services provided by an other specified entity (as defined in paragraph (9)(D)(iii)) unless such services are provided in accordance with a contract between the State and such entity which satisfies the requirements of paragraph (2)(A)(xiii).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H6B717225D9014591BEB1FB8AB1E4909C"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall apply to contracts between States and managed care entities, other specified entities, or pharmacy benefit managers that have an effective date beginning on or after the date that is 18 months after the date of enactment of this Act.</text></subsection><subsection id="H1DCB285EEC93468B86351A6708019095"><enum>(d)</enum><header>Implementation</header><paragraph id="H72B8BEEBC7134F12A0068A0D7F990DF0"><enum>(1)</enum><header>In general</header><text>Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by this section by program instruction or otherwise.</text></paragraph><paragraph id="H1A111BBC80D34FE89A10303558B4555D"><enum>(2)</enum><header>Nonapplication of administrative procedure act</header><text>Implementation of the amendments made by this section shall be exempt from the requirements of section 553 of title 5, United States Code.</text></paragraph></subsection><subsection id="H5E7BB7BE0BA743A6AF50140F39E10F90" commented="no" display-inline="no-display-inline"><enum>(e)</enum><header>Nonapplication of paperwork reduction act</header><text><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/44/35">Chapter 35</external-xref> of title 44, United States Code, shall not apply to any data collection undertaken by the Secretary of Health and Human Services under section 1927(e) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(e)</external-xref>), as amended by this section.</text></subsection></section></title><title id="H3935AA91AC524702AA8A92F40E8B4108"><enum>II</enum><header>Medicare</header><section id="HA2106815578B436B9A23AAC08EDA44E8"><enum>201.</enum><header>Extension of increased inpatient hospital payment adjustment for certain low-volume hospitals</header><subsection id="HB11445E1318F40EBBF689FA3A84885E4"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1886(d)(12) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395ww">42 U.S.C. 1395ww(d)(12)</external-xref>) is amended—</text><paragraph id="H7B59E5F93BA3495D8195284C6A989068"><enum>(1)</enum><text display-inline="yes-display-inline">in subparagraph (B), in the matter preceding clause (i), by striking <quote>fiscal year 2025 beginning on April 1, 2025, and ending on September 30, 2025, and in fiscal year 2026</quote> and inserting <quote>fiscal year 2026 beginning on January 1, 2026, and ending on September 30, 2026, and in fiscal year 2027</quote>; </text></paragraph><paragraph id="H37215DB1DC544D9184D05B16F42678BF"><enum>(2)</enum><text>in subparagraph (C)(i)—</text><subparagraph id="HF94C74143340464C87B570CF9A5E2FCA"><enum>(A)</enum><text>in the matter preceding subclause (I)—</text><clause id="H142B69F86E2C44E7A0FD16AD5421551A"><enum>(i)</enum><text>by striking <quote>through 2024</quote> and inserting <quote>through 2025</quote>;</text></clause><clause id="H17980DE254644E09BE1C50160C5102E4"><enum>(ii)</enum><text>by striking <quote>fiscal year 2025</quote> and inserting <quote>fiscal year 2026</quote>;</text></clause><clause id="H4C04EE68C2D94A26B5AA8FAB9AB8BB0C"><enum>(iii)</enum><text>by striking <quote>October 1, 2024</quote> and inserting <quote>October 1, 2025</quote>; and</text></clause><clause id="H620F7485CC3B47499BBD0B33D1EBA135"><enum>(iv)</enum><text>by striking <quote>March 31, 2025</quote> and inserting <quote>December 31, 2025</quote>; </text></clause></subparagraph><subparagraph id="HF9B5E6C6A6714DD19CDD1740F5209C16"><enum>(B)</enum><text>in subclause (III)—</text><clause id="H1CF5306C8CD843E5BA840448D05F41BD"><enum>(i)</enum><text>by striking <quote>through 2024</quote> and inserting <quote>through 2025</quote>;</text></clause><clause id="H52243E979FEE4B01925E91A4EEFE6162"><enum>(ii)</enum><text>by striking <quote>fiscal year 2025</quote> and inserting <quote>fiscal year 2026</quote>;</text></clause><clause id="HD3C0547351694F9EBC402A7F716AE8BC" display-inline="no-display-inline"><enum>(iii)</enum><text>by striking <quote>October 1, 2024</quote> and inserting <quote>October 1, 2025</quote>; and</text></clause><clause id="HA622E493D87648DBAFE30DDB5195133D"><enum>(iv)</enum><text>by striking <quote>March 31, 2025</quote> and inserting <quote>December 31, 2025</quote>; and </text></clause></subparagraph><subparagraph id="H1342CAABA4AC47BD9DF358BFBCA2184C"><enum>(C)</enum><text>in subclause (IV)—</text><clause id="H232696C370F24720BE8F6345B097D466"><enum>(i)</enum><text>by striking <quote>fiscal year 2025</quote> and inserting <quote>fiscal year 2026</quote>;</text></clause><clause id="HF76B7EFAA0454D66A0BC9BAC6AB21229"><enum>(ii)</enum><text>by striking <quote>April 1, 2025</quote> and inserting <quote>January 1, 2026</quote>;</text></clause><clause id="H8060B25505134E7EA960AA90F474BEE0"><enum>(iii)</enum><text>by striking <quote>September 30, 2025</quote> and inserting <quote>September 30, 2026</quote>; and</text></clause><clause id="H68BEC29EB8B54065936D770B5C2D59F0"><enum>(iv)</enum><text>by striking <quote>fiscal year 2026</quote> and inserting <quote>fiscal year 2027</quote>; and </text></clause></subparagraph></paragraph><paragraph id="HC4F90B853C1745C49EA31BA031B820D3"><enum>(3)</enum><text>in subparagraph (D)—</text><subparagraph id="H0D15F54363E94B62AD9EA2CA477640B7"><enum>(A)</enum><text>in the matter preceding clause (i)—</text><clause id="HEA27ACC4512D4A4989B2745FBD25EEFF"><enum>(i)</enum><text>by striking <quote>through 2024</quote> and inserting <quote>through 2025</quote>;</text></clause><clause id="H4AC20B1753414254A3E1E6EBEF3CA3E6"><enum>(ii)</enum><text>by striking <quote>fiscal year 2025</quote> and inserting <quote>fiscal year 2026</quote>;</text></clause><clause id="H71451557CBC24C9CA5F24A212D6FEFA6"><enum>(iii)</enum><text>by striking <quote>October 1, 2024</quote> and inserting <quote>October 1, 2025</quote>; and</text></clause><clause id="H5BD0FA3E96B244D7A28AB798C2AC6253"><enum>(iv)</enum><text>by striking <quote>March 31, 2025</quote> and inserting <quote>December 31, 2025</quote>; and </text></clause></subparagraph><subparagraph id="HB7EAFF8BEDF645B3A00CF2664D0DF625"><enum>(B)</enum><text>in clause (ii)—</text><clause id="H7B1A520F91FF418FB0C45F61A477526C"><enum>(i)</enum><text>by striking <quote>through 2024</quote> and inserting <quote>through 2025</quote>;</text></clause><clause id="H981FC7A500DE4C369A8CF5757FE91D74"><enum>(ii)</enum><text>by striking <quote>fiscal year 2025</quote> and inserting <quote>fiscal year 2026</quote>;</text></clause><clause id="H9A0799E8FF6841A0B6B95E4E37AC776B"><enum>(iii)</enum><text>by striking <quote>October 1, 2024</quote> and inserting <quote>October 1, 2025</quote>; and</text></clause><clause id="H599523E6490E438CA3A3382EF37C1183"><enum>(iv)</enum><text>by striking <quote>March 31, 2025</quote> and inserting <quote>December 31, 2025</quote>. </text></clause></subparagraph></paragraph></subsection><subsection id="HCB0597E31A754C4EAD0C31045A3A51A5"><enum>(b)</enum><header>Implementation</header><text display-inline="yes-display-inline">Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by this section by program instruction or otherwise.</text></subsection></section><section id="H3D8F75C872814B9789D08B456243285A"><enum>202.</enum><header>Extension of the Medicare-dependent hospital (MDH) program</header><subsection id="HFA1D879AB2F24476A375A65CF86FB301"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1886(d)(5)(G) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395ww">42 U.S.C. 1395ww(d)(5)(G)</external-xref>) is amended—</text><paragraph id="HA289F7238EC446F69E2E07AFE9F4A7E1"><enum>(1)</enum><text>in clause (i), by striking <quote>April 1, 2025</quote> and inserting <quote>January 1, 2026</quote>; and</text></paragraph><paragraph id="HA7222506D0824E0895B62B1C3694B212"><enum>(2)</enum><text>in clause (ii)(II), by striking <quote>April 1, 2025</quote> and inserting <quote>January 1, 2026</quote>.</text></paragraph></subsection><subsection id="H9DF0524B66B342A18910DDF6511382EC"><enum>(b)</enum><header>Conforming amendments</header><paragraph id="H8DF0ABAE79B74FA79111F4B9F4B16907"><enum>(1)</enum><header>In general</header><text>Section 1886(b)(3)(D) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395ww">42 U.S.C. 1395ww(b)(3)(D)</external-xref>) is amended—</text><subparagraph id="H07BA5D3CFAA54E45856BB0336C7802EF"><enum>(A)</enum><text>in the matter preceding clause (i), by striking <quote>April 1, 2025</quote> and inserting <quote>January 1, 2026</quote>; and</text></subparagraph><subparagraph id="HA524FCCB0EC447B78827195F948904F9"><enum>(B)</enum><text>in clause (iv)—</text><clause id="H2B1067BDC92042E7A84C01B4B6464A8E"><enum>(i)</enum><text>by striking <quote>fiscal year 2024</quote> and inserting <quote>fiscal year 2025</quote>;</text></clause><clause id="H299F58E8357E499DA8FCA559C3E196BA"><enum>(ii)</enum><text>by striking <quote>fiscal year 2025</quote> and inserting <quote>fiscal year 2026</quote>;</text></clause><clause id="HA952FDAE5E7E413B929D7ECB2892DE31"><enum>(iii)</enum><text>by striking <quote>October 1, 2024</quote> and inserting <quote>October 1, 2025</quote>; and</text></clause><clause id="HF79496BC311148E49CC895C27FB20E0B"><enum>(iv)</enum><text>by striking <quote>March 31, 2025</quote> and inserting <quote>December 31, 2025</quote>. </text></clause></subparagraph></paragraph><paragraph id="H8830785BF7D74954B998F57A2AEDA14E"><enum>(2)</enum><header>Permitting hospitals to decline reclassification</header><text display-inline="yes-display-inline">Section 13501(e)(2) of the Omnibus Budget Reconciliation Act of 1993 (<external-xref legal-doc="usc" parsable-cite="usc/42/1395ww">42 U.S.C. 1395ww</external-xref> note) is amended—</text><subparagraph id="H831CB04C54364E269C46F3EA1088FFCB" display-inline="no-display-inline"><enum>(A)</enum><text>by striking <quote>through 2024</quote> and inserting <quote>through 2025</quote>;</text></subparagraph><subparagraph id="H08483C35B3EA429CB7C98D7841B74702"><enum>(B)</enum><text>by striking <quote>fiscal year 2025</quote> and inserting <quote>fiscal year 2026</quote>;</text></subparagraph><subparagraph id="H19A141AE21BA4476ACCF9F14EA964E5D"><enum>(C)</enum><text>by striking <quote>October 1, 2024</quote> and inserting <quote>October 1, 2025</quote>; and</text></subparagraph><subparagraph id="H829F5C53C70B458DA8CCCD7CBD6D7B95"><enum>(D)</enum><text>by striking <quote>March 31, 2025</quote> and inserting <quote>December 31, 2025</quote>. </text></subparagraph></paragraph></subsection></section><section id="H8DC1A346224A473D9F33190D23268732"><enum>203.</enum><header>Extension of add-on payments for ambulance services</header><text display-inline="no-display-inline">Section 1834(l) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(l)</external-xref>) is amended—</text><paragraph id="HC09866822AAD46149360BB1E088CC021"><enum>(1)</enum><text>in paragraph (12)(A), by striking <quote>April 1, 2025</quote> and inserting <quote>January 1, 2027</quote>; and</text></paragraph><paragraph id="H030F3B08E6FA4D85A61F93AE128460F1"><enum>(2)</enum><text>in paragraph (13), by striking <quote>April 1, 2025</quote> each place it appears and inserting <quote>January 1, 2027</quote> in each such place.</text></paragraph></section><section id="H103DE72F0E404893BC35560542266A98" commented="no"><enum>204.</enum><header>Extending incentive payments for participation in eligible alternative payment models</header><subsection id="HD69356D751D94885867F0B0502D3A2C5" commented="no"><enum>(a)</enum><header>In general</header><text>Section 1833(z) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(z)</external-xref>) is amended—</text><paragraph id="H10D9A3822685455E82D7956171D49BA2" commented="no"><enum>(1)</enum><text>in paragraph (1)(A)—</text><subparagraph id="H3C5334E1F84749C082913A37FAB93307" commented="no"><enum>(A)</enum><text>by striking <quote>with 2026</quote> and inserting <quote>with 2027</quote>; and</text></subparagraph><subparagraph id="HCBD910BD7F7F4D14B65968A372E81CD6" commented="no"><enum>(B)</enum><text>by inserting <quote>, or, with respect to 2027, 3.53 percent</quote> after <quote>1.88 percent</quote>;</text></subparagraph></paragraph><paragraph id="H06F54B5C2DDC4A8CAA65F4BE037C9AFC" commented="no"><enum>(2)</enum><text>in paragraph (2)—</text><subparagraph id="H4AF335C52FB944E7B1D970D767927A38" commented="no"><enum>(A)</enum><text>in subparagraph (B)—</text><clause id="H3D01B8C4D20341C88990DE9EA989C199" commented="no"><enum>(i)</enum><text>in the heading, by striking <quote>2026</quote> and inserting <quote>2027</quote>; and</text></clause><clause id="H38B7FA54BE0E46809FE074E7C68464AD" commented="no"><enum>(ii)</enum><text>in the matter preceding clause (i), by striking <quote>2026</quote> and inserting <quote>2027</quote>;</text></clause></subparagraph><subparagraph id="H2788B9C6A901410AB22944D5FA496F17" commented="no"><enum>(B)</enum><text>in subparagraph (C)—</text><clause id="HBE3B14B9CAFF4930BB3C9A580FFDD90A" commented="no"><enum>(i)</enum><text>in the heading, by striking <quote>2027</quote> and inserting <quote>2028</quote>; and</text></clause><clause id="H6C343FE0032747D2B3EB4DB1B1F63718" commented="no"><enum>(ii)</enum><text>in the matter preceding clause (i), by striking <quote>2027</quote> and inserting <quote>2028</quote>; and</text></clause></subparagraph><subparagraph id="H30B6C9D2F13A48C0817F2B31514C36A3" commented="no"><enum>(C)</enum><text>in subparagraph (D), by striking <quote>and 2026</quote> and inserting <quote>2026, and 2027</quote>; and</text></subparagraph></paragraph><paragraph id="HDA7670EA2B774D19B2B101501CF9BBFF" commented="no"><enum>(3)</enum><text>in paragraph (4)(B), by inserting <quote>or, with respect to 2027, 3.53 percent</quote> after <quote>1.88 percent</quote>. </text></paragraph></subsection><subsection id="H26D67520FA16427594DA1623CA1075D0" commented="no"><enum>(b)</enum><header>Conforming amendments</header><text display-inline="yes-display-inline">Section 1848(q)(1)(C)(iii) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-4">42 U.S.C. 1395w–4(q)(1)(C)(iii)</external-xref>) is amended—</text><paragraph id="H95A01B57C4B84F19B7D318745074751C" commented="no"><enum>(1)</enum><text>in subclause (II), by striking <quote>2026</quote> and inserting <quote>2027</quote>; and</text></paragraph><paragraph id="H4B36F42943264E799008DB02581AE7E4" commented="no"><enum>(2)</enum><text>in subclause (III), by striking <quote>2027</quote> and inserting <quote>2028</quote>.</text></paragraph></subsection></section><section id="H5506069197414434AFEE9E4F9749F0A4" commented="no"><enum>205.</enum><header>Temporary payment increase under the Medicare physician fee schedule to account for exceptional circumstances</header><subsection id="H2AED7A23F8FB4F118393789313C315F5" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1848(t)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-4">42 U.S.C. 1395w–4(t)(1)</external-xref>) is amended—</text><paragraph id="HE0CD6253B9474B9798738D1472C8F8B0" commented="no"><enum>(1)</enum><text>in subparagraph (D), by striking <quote>and</quote> at the end;</text></paragraph><paragraph id="HC8B5A870B81A481FAF152654636A616C" commented="no"><enum>(2)</enum><text>in subparagraph (E), by striking the period at the end and inserting <quote>; and</quote>; and</text></paragraph><paragraph id="HE0D36E489F7C444382E3FD6B3CD1E822" commented="no"><enum>(3)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" id="H99B8CEA13C6E4DD48D829492D86F798A" display-inline="no-display-inline"><subparagraph id="H96F19CD8897A47278C1A45D48AB0CFB6" commented="no"><enum>(F)</enum><text display-inline="yes-display-inline">such services furnished on or after January 1, 2025, and before January 1, 2026, by 2.5 percent.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H7933035E114C40B3967F26B6CD973882" commented="no"><enum>(b)</enum><header>Conforming amendment</header><text display-inline="yes-display-inline">Section 1848(c)(2)(B)(iv)(V) is amended by striking <quote>or 2024</quote> and inserting <quote>2024, or 2025</quote>.</text></subsection></section><section id="H1F4A5338AC0B46478A5A3D7B93EEB142"><enum>206.</enum><header>Extension of funding for quality measure endorsement, input, and selection</header><text display-inline="no-display-inline">Section 1890(d)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395aaa">42 U.S.C. 1395aaa(d)(2)</external-xref>) is amended—</text><paragraph id="HE503FD68B78D4A30A67B6895C732D27B"><enum>(1)</enum><text>in the first sentence—</text><subparagraph id="HB204A9783D2C4F92BEDD8CD9882EF271"><enum>(A)</enum><text>by striking <quote>$11,030,000</quote> and inserting <quote>$20,030,000</quote> ; and</text></subparagraph><subparagraph id="HF94A68F738B64EB8B09035FED8D9E6D8"><enum>(B)</enum><text>by striking <quote>March 31</quote> and inserting <quote>December 31</quote>; and </text></subparagraph></paragraph><paragraph id="H30F9AECCAAF94F91A4EEBCC08FE89A0D"><enum>(2)</enum><text display-inline="yes-display-inline">in the third sentence, by striking <quote>March 31</quote> and inserting <quote>December 31</quote>. </text></paragraph></section><section id="HF0549E3C1E704A7FBF6AF79B5C3A6318"><enum>207.</enum><header>Extension of funding outreach and assistance for low-income programs</header><subsection id="HCF81FA0E340C446489289313202D62E4"><enum>(a)</enum><header>State health insurance assistance programs</header><text display-inline="yes-display-inline">Subsection (a)(1)(B) of section 119 of the Medicare Improvements for Patients and Providers Act of 2008 (<external-xref legal-doc="usc" parsable-cite="usc/42/1395b-3">42 U.S.C. 1395b–3</external-xref> note) is amended—</text><paragraph id="H59226857D5D94F1784867F4E9A836FA4"><enum>(1)</enum><text>in clause (xiii), by striking <quote>and</quote> at the end; </text></paragraph><paragraph id="H14B0F3F81842495EAD424F213B3BCEB3"><enum>(2)</enum><text>in clause (xiv), by striking the period and inserting <quote>; and</quote>; and</text></paragraph><paragraph id="H68C9E393E35F428391F948D60D7FC959"><enum>(3)</enum><text>by inserting after clause (xiv) the following new clause:</text><quoted-block style="OLC" id="H33AFE3FFF00C4D61926AF6BCDFD6835F" display-inline="no-display-inline"><clause id="H39AB661D56304AFDA3D2155EB25F7A48"><enum>(xv)</enum><text display-inline="yes-display-inline">for the period beginning on April 1, 2025, and ending on December 31, 2026, $30,000,000.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HE31E385B37ED4E2089A39C9CAB44CA62"><enum>(b)</enum><header>Area agencies on aging</header><text display-inline="yes-display-inline">Subsection (b)(1)(B) of such section 119 is amended—</text><paragraph id="HB8AB22A1A33E4B78B9A147FE6A9242A6"><enum>(1)</enum><text>in clause (xiii), by striking <quote>and</quote> at the end; </text></paragraph><paragraph id="H7DC0D75D4A014804A69AEFBA2ABD96AB"><enum>(2)</enum><text>in clause (xiv), by striking the period and inserting <quote>; and</quote>; and</text></paragraph><paragraph id="HB54CB83E1DA14883902F22330B246D93"><enum>(3)</enum><text>by inserting after clause (xiv) the following new clause:</text><quoted-block style="OLC" id="HE2EDA5BE77CB46CC9187EB57879449CA" display-inline="no-display-inline"><clause id="H22E7942248BE4445B312C2FF3A1DC881"><enum>(xv)</enum><text display-inline="yes-display-inline">for the period beginning on April 1, 2025, and ending on December 31, 2026, $30,000,000.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HD9F3726820E64EEC8FD89B3FC6114D0C"><enum>(c)</enum><header>Aging and disability resource centers</header><text display-inline="yes-display-inline">Subsection (c)(1)(B) of such section 119 is amended—</text><paragraph id="HCDB5223FCA2843F8A5FFBEE9632CE421"><enum>(1)</enum><text>in clause (xiii), by striking <quote>and</quote> at the end; </text></paragraph><paragraph id="HFDD7BA11CD29416BAADEF9A3C2C29B05"><enum>(2)</enum><text>in clause (xiv), by striking the period and inserting <quote>; and</quote>; and</text></paragraph><paragraph id="H052949831470498E8FB6DA9C314C2A76"><enum>(3)</enum><text>by inserting after clause (xiv) the following new clause:</text><quoted-block style="OLC" id="HD356A349E46547FE901BB15DEF3AA432" display-inline="no-display-inline"><clause id="H1CD9C7A15AE44902848EBF15B64F7DE9"><enum>(xv)</enum><text display-inline="yes-display-inline">for the period beginning on April 1, 2025, and ending on December 31, 2026, $10,000,000.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H47AAE67BBF384CD4A0904C935EF45424"><enum>(d)</enum><header>Coordination of efforts To inform older Americans about benefits available under Federal and State programs</header><text display-inline="yes-display-inline">Subsection (d)(2) of such section 119 is amended—</text><paragraph id="H52301C46A62643739AA211DC02226BDE"><enum>(1)</enum><text>in clause (xiii), by striking <quote>and</quote> at the end; </text></paragraph><paragraph id="H990680407FEF46BD9200DA0E040DD89F"><enum>(2)</enum><text>in clause (xiv), by striking the period and inserting <quote>; and</quote>; and</text></paragraph><paragraph id="H1A21F7C37B0D47B182B3A7BECA93CF9F"><enum>(3)</enum><text>by inserting after clause (xiv) the following new clause:</text><quoted-block style="OLC" id="H77180BB0A7AF4D1A8098044EC8BF7F66" display-inline="no-display-inline"><clause id="H76B89C64C6474094922DCD341EF9D37C"><enum>(xv)</enum><text display-inline="yes-display-inline">for the period beginning on April 1, 2025, and ending on December 31, 2026, $30,000,000.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section><section id="H234687799F1540F481264BECAE2D4D66" commented="no"><enum>208.</enum><header>Extension of the work geographic index floor</header><text display-inline="no-display-inline">Section 1848(e)(1)(E) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-4">42 U.S.C. 1395w–4(e)(1)(E)</external-xref>) is amended by striking <quote>April 1, 2025</quote> and inserting <quote>January 1, 2026</quote>.</text></section><section id="HA9EA81521CDD4C78A90FC6200C8E915F" section-type="subsequent-section"><enum>209.</enum><header>Extension of certain telehealth flexibilities</header><subsection id="H3313E9B4ADF04F16BF3E38843DE9DA39"><enum>(a)</enum><header>Removing geographic requirements and expanding originating sites for telehealth services</header><text display-inline="yes-display-inline">Section 1834(m) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)</external-xref>) is amended—</text><paragraph id="HA10AE4AA9A0843D6BB6728E08EFC8F79"><enum>(1)</enum><text>in paragraph (2)(B)(iii), by striking <quote>ending March 31, 2025</quote> and inserting <quote>ending December 31, 2026</quote>; and</text></paragraph><paragraph id="H5AA0D65F3AE04267BF40D59B406AF587"><enum>(2)</enum><text>in paragraph (4)(C)(iii), by striking <quote>ending on March 31, 2025</quote> and inserting <quote>ending on December 31, 2026</quote>.</text></paragraph></subsection><subsection id="H2023A554053949B79E562CE211DDFA58"><enum>(b)</enum><header>Expanding practitioners eligible To furnish telehealth services</header><text>Section 1834(m)(4)(E) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(4)(E)</external-xref>) is amended by striking <quote>ending on March 31, 2025</quote> and inserting <quote>ending on December 31, 2026</quote>.</text></subsection><subsection id="H926A98F3EDB84846BEB1BFA6072E8267"><enum>(c)</enum><header>Extending telehealth services for federally qualified health centers and rural health clinics</header><text>Section 1834(m)(8) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(8)</external-xref>) is amended—</text><paragraph id="H267711BB356B49DEBACA696B22BB57C0"><enum>(1)</enum><text>in subparagraph (A), by striking <quote>ending on March 31, 2025</quote> and inserting <quote>ending on December 31, 2026</quote>;</text></paragraph><paragraph id="H00BDB4EF6370400FB4689EBD95D0FD6D" commented="no"><enum>(2)</enum><text display-inline="yes-display-inline">in subparagraph (B)—</text><subparagraph id="H4D52DD4C58D54F06BF8B4D598EDDC3E2" commented="no"><enum>(A)</enum><text>in the subparagraph heading, by inserting <quote><header-in-text level="subparagraph" style="OLC">before 2025</header-in-text></quote> after <quote><header-in-text level="subparagraph" style="OLC">rule</header-in-text></quote>; </text></subparagraph><subparagraph id="HDA3ADB3059294D80B0A2C3143C34684F" commented="no"><enum>(B)</enum><text>in clause (i), by striking <quote>during the periods for which subparagraph (A) applies</quote> and inserting <quote>before January 1, 2025</quote>; and</text></subparagraph><subparagraph id="H00DDCE99EF54414EBBDB9E6BFB7DAE4C" commented="no"><enum>(C)</enum><text>in clause (ii), by inserting <quote>furnished to an eligible telehealth individual before January 1, 2025</quote> after <quote>telehealth services</quote>; and </text></subparagraph></paragraph><paragraph id="H2F6A7A24830649ED93675EB9B19CFB8E" commented="no"><enum>(3)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" id="H630548044C704AB590FBC5A700B0F572" display-inline="no-display-inline"><subparagraph id="H6EB381DC3DCD4917B00689908F716F6B" commented="no"><enum>(C)</enum><header>Payment rule for 2025 and 2026</header><clause id="HB5D4FA08FE5C4FF99E52D4872B24FEB5" commented="no"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">A telehealth service furnished to an eligible telehealth individual by a Federally qualified health center or rural health clinic on or after January 1, 2025, and before January 1, 2027, shall be paid as a Federally qualified health center service or rural health clinic service (as applicable) under the prospective payment system established under section 1834(o) or the methodology for all-inclusive rates established under section 1833(a)(3), respectively.</text></clause><clause id="H1D082F7CA08C423890D0E89622F40A24" commented="no"><enum>(ii)</enum><header>Treatment of costs</header><text display-inline="yes-display-inline">Costs associated with the furnishing of telehealth services by a Federally qualified health center or rural health clinic on or after January 1, 2025, and before January 1, 2027, shall be considered allowable costs for purposes of the prospective payment system established under section 1834(o) and the methodology for all-inclusive rates established under section 1833(a)(3), as applicable.</text></clause><clause id="H66FEF9B7A75D4A3EA814A1BDB83BA7FF" commented="no"><enum>(iii)</enum><header>Requiring modifiers</header><text display-inline="yes-display-inline">Not later than July 1, 2025, the Secretary shall establish requirements to include 1 or more codes or modifiers, as determined appropriate by the Secretary, in the case of claims for telehealth services furnished to an eligible telehealth individual by a Federally qualified health center or rural health clinic.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HCB2F2AAB01E04549AEAC8129880843A6"><enum>(d)</enum><header>Delaying the in-Person requirements under Medicare for mental health services furnished through telehealth and telecommunications technology</header><paragraph id="H2E70FA1EB3DF4F858E440BCA3C1B740C"><enum>(1)</enum><header>Delay in requirements for mental health services furnished through telehealth</header><text display-inline="yes-display-inline">Section 1834(m)(7)(B)(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(7)(B)(i)</external-xref>) is amended, in the matter preceding subclause (I), by striking <quote>on or after April 1, 2025</quote> and inserting <quote>on or after January 1, 2027</quote>.</text></paragraph><paragraph id="H1945EE47075F4DAAB15BB319CF53A5B8"><enum>(2)</enum><header>Mental health visits furnished by rural health clinics</header><text display-inline="yes-display-inline">Section 1834(y)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(y)(2)</external-xref>) is amended by striking <quote>April 1, 2025</quote> and inserting <quote>January 1, 2027</quote>.</text></paragraph><paragraph id="HD73D1C2CD22A4500BD3D0099739A6BCF"><enum>(3)</enum><header>Mental health visits furnished by Federally qualified health centers</header><text display-inline="yes-display-inline">Section 1834(o)(4)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(o)(4)(B)</external-xref>) is amended by striking <quote>April 1, 2025</quote> and inserting <quote>January 1, 2027.</quote>.</text></paragraph></subsection><subsection id="HE358CFA648E44BE3B103FEC40C0792F4"><enum>(e)</enum><header>Allowing for the furnishing of audio-Only telehealth services</header><text display-inline="yes-display-inline">Section 1834(m)(9) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(9)</external-xref>) is amended by striking <quote>ending on March 31, 2025</quote> and inserting <quote>ending on December 31, 2026</quote>.</text></subsection><subsection id="HA5ECAEAED860449AA5D92F895BFC0692" display-inline="no-display-inline" commented="no"><enum>(f)</enum><header>Extending use of telehealth To conduct face-to-Face encounter prior to recertification of eligibility for hospice care</header><text display-inline="yes-display-inline">Section 1814(a)(7)(D)(i)(II) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395f">42 U.S.C. 1395f(a)(7)(D)(i)(II)</external-xref>) is amended—</text><paragraph id="HC5F8DECD81CF4E929288C84FDEC718BE" commented="no"><enum>(1)</enum><text>by striking <quote>ending on March 31, 2025</quote> and inserting <quote>ending on December 31, 2026</quote>; and</text></paragraph><paragraph id="H3E3D9FE7578546E8942125823B5C6D35" commented="no"><enum>(2)</enum><text>by inserting <quote>, except that this subclause shall not apply in the case of such an encounter with an individual occurring on or after January 1, 2025, if such individual is located in an area that is subject to a moratorium on the enrollment of hospice programs under this title pursuant to section 1866(j)(7), if such individual is receiving hospice care from a provider that is subject to enhanced oversight under this title pursuant to section 1866(j)(3), or if such encounter is performed by a hospice physician or nurse practitioner who is not enrolled under section 1866(j) and is not an opt-out physician or practitioner (as defined in section 1802(b)(6)(D))</quote> before the semicolon.</text></paragraph></subsection><subsection id="H97304FB8ED8B48D38779AF4289D877C2"><enum>(g)</enum><header>Requiring modifiers for telehealth services in certain instances</header><text>Section 1834(m) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HA9DDF9C5041749FAABA40661F1A0FD57"><paragraph id="HA840E66B66BA474E82D8782B760C81AF"><enum>(10)</enum><header>Required use of modifiers in certain instances</header><text display-inline="yes-display-inline">Not later than January 1, 2026, the Secretary shall establish requirements to include 1 or more codes or modifiers, as determined appropriate by the Secretary, in the case of—</text><subparagraph id="H0629BD6D31764E1C9B58A465BFC63AEC"><enum>(A)</enum><text display-inline="yes-display-inline">claims for telehealth services under this subsection that are furnished through a telehealth virtual platform—</text><clause id="H9BA3B0229F0B48C0A423D30CBC38F560"><enum>(i)</enum><text>by a physician or practitioner that contracts with an entity that owns such virtual platform; or</text></clause><clause id="H7399AC80ADBE40768515376A1B63367E"><enum>(ii)</enum><text>for which a physician or practitioner has a payment arrangement with an entity for use of such virtual platform; and</text></clause></subparagraph><subparagraph id="HF2CFCCFABCE34782A00DEEA98643B268"><enum>(B)</enum><text display-inline="yes-display-inline">claims for telehealth services under this subsection that are furnished incident to a physician’s or practitioner’s professional service.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H276350B4452C49289188FBCC38018745"><enum>(h)</enum><header>Program instruction authority</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services may implement the amendments made by this section through program instruction or otherwise.</text></subsection></section><section id="H39E0CA975ECC4A2EA4D70A333A7E45C5"><enum>210.</enum><header>Requiring modifier for use of telehealth to conduct face-to-face encounter prior to recertification of eligibility for hospice care</header><text display-inline="no-display-inline">Section 1814(a)(7)(D)(i)(II) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395f">42 U.S.C. 1395f(a)(7)(D)(i)(II)</external-xref>), as amended by section 209(f) of the Health Improvements, Extenders, and Reauthorizations Act, is further amended by inserting <quote>, but only if, in the case of such an encounter occurring on or after January 1, 2026, any hospice claim includes 1 or more modifiers or codes (as specified by the Secretary) to indicate that such encounter was conducted via telehealth</quote> after <quote>as determined appropriate by the Secretary</quote>.</text></section><section id="HCC9B60C45469445C8FF5EE3B71F4C552"><enum>211.</enum><header>Extending acute hospital care at home waiver flexibilities</header><text display-inline="no-display-inline">Section 1866G of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395cc-7">42 U.S.C. 1395cc–7</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H8C412FE14ABC4449B17B0AF7CA1C4B62"><enum>(1)</enum><text>in the section heading, by inserting <quote><header-in-text style="OLC" level="section">the Thomas R. Carper, Tim Scott, Brad R. Wenstrup, D.P.M., and Earl Blumenauer</header-in-text></quote> after <quote><header-in-text style="OLC" level="section">Extension of</header-in-text></quote>; </text></paragraph><paragraph id="H69B22766D457401E9F393D99DF362472"><enum>(2)</enum><text>in subsection (a)—</text><subparagraph id="H8F0A7575B7194A218F38038B211A24FB"><enum>(A)</enum><text>in paragraph (1)—</text><clause commented="no" display-inline="no-display-inline" id="H676294D2A168475A9F80EAE79E8999FD"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>March 31, 2025</quote> and inserting <quote>December 31, 2029</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H33AFBD078DC54ED29C234D64BF3B8077"><enum>(ii)</enum><text>by striking <quote>in the Acute Hospital Care at Home initiative of the Secretary</quote> and inserting <quote>in the Thomas R. Carper, Tim Scott, Brad R. Wenstrup, D.P.M., and Earl Blumenauer Acute Hospital Care at Home initiative of the Secretary (in this section referred to as the <quote>Acute Hospital Care at Home initiative</quote>)</quote>; </text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H05AF677FFFB34894A34D5323C22F01D5"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2), by striking <quote>of the Secretary</quote>; and</text></subparagraph><subparagraph id="H666FFA95C62D4AE685952F89A77B643E"><enum>(C)</enum><text>in paragraph (3)(E), by adding at the end the following new flush sentence:</text><quoted-block style="OLC" id="H816FCFFB0BD54935A7ABC57342D234E6" display-inline="no-display-inline"><quoted-block-continuation-text quoted-block-continuation-text-level="subparagraph">The Secretary may require that such data and information be submitted through a hospital’s cost report, through such survey instruments as the Secretary may develop, through medical record information, or through such other means as the Secretary determines appropriate.</quoted-block-continuation-text><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H4919D20728734A138A442BAB7319DAF7"><enum>(3)</enum><text>in subsection (b)—</text><subparagraph commented="no" display-inline="no-display-inline" id="H7C4E073EA0E4410EBD1BB0FD803A2D20"><enum>(A)</enum><text display-inline="yes-display-inline">in the subsection heading, by striking <quote><header-in-text level="subsection" style="OLC">Study</header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC">Initial study</header-in-text></quote>; </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HEAF9DDE1AF214FD28405B62D98A739FA"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1)(A), by striking <quote>of the Secretary</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H0FE844C765C442E09515991D19CFCAEC"><enum>(C)</enum><text>in paragraph (3), by inserting <quote>or subsection (c)</quote> before the period at the end;</text></subparagraph></paragraph><paragraph id="H0494C992A9D940608A21666A389582C6"><enum>(4)</enum><text>by redesignating subsections (c) and (d) as subsections (d) and (e), respectively; and</text></paragraph><paragraph id="H1909BD914893454187063776F85D11AA"><enum>(5)</enum><text>by inserting after subsection (b) the following new subsection:</text><quoted-block id="H5B07E4B4554A41AD8F51C7277A7D8908" display-inline="no-display-inline" style="OLC"><subsection id="H599BC5468C5549C1B29EED80CFFDBAA4"><enum>(c)</enum><header>Subsequent study and report</header><paragraph id="HAB07C759241142C398883562F770ACBB"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than September 30, 2028, the Secretary shall conduct a study to—</text><subparagraph id="HB00C99B736934CD89DD362A0ACE888D9"><enum>(A)</enum><text display-inline="yes-display-inline">analyze, to the extent practicable, the criteria established by hospitals under the Acute Hospital Care at Home initiative to determine which individuals may be furnished services under such initiative; and</text></subparagraph><subparagraph id="H5426ED1F0C764B4DB8F559C5C4EEFAC9"><enum>(B)</enum><text>analyze and compare (both within and between hospitals participating in the initiative, and relative to comparable hospitals that do not participate in the initiative, for relevant parameters such as diagnosis-related groups)—</text><clause id="HFFCDFAEA23A74D5E8CCFAECEC302D758"><enum>(i)</enum><text>quality of care furnished to individuals with similar conditions and characteristics in the inpatient setting and through the Acute Hospital Care at Home initiative, including health outcomes, hospital readmission rates (including readmissions both within and beyond 30 days post-discharge), hospital mortality rates, length of stay, infection rates, composition of care team (including the types of labor used, such as contracted labor), the ratio of nursing staff, transfers from the hospital to the home, transfers from the home to the hospital (including the timing, frequency, and causes of such transfers), transfers and discharges to post-acute care settings (including the timing, frequency, and causes of such transfers and discharges), and patient and caregiver experience of care;</text></clause><clause id="H043B710245F5443FA810B9EB906E0003"><enum>(ii)</enum><text>clinical conditions treated and diagnosis-related groups of discharges from inpatient settings relative to discharges from the Acute Hospital Care at Home initiative;</text></clause><clause id="H0032D75905A44000BD4A6341447052D7"><enum>(iii)</enum><text>costs incurred by the hospital for furnishing care in inpatient settings relative to costs incurred by the hospital for furnishing care through the Acute Hospital Care at Home initiative, including costs relating to staffing, equipment, food, prescriptions, and other services, as determined by the Secretary;</text></clause><clause id="HAD7343BDF45A4F518F43157CB2DBD4A5"><enum>(iv)</enum><text>the quantity, mix, and intensity of services (such as in-person visits and virtual contacts with patients and the intensity of such services) furnished in inpatient settings relative to the Acute Hospital Care at Home initiative, and, to the extent practicable, the nature and extent of family or caregiver involvement; </text></clause><clause id="H18374986338D4951A57A71B3A178E5C4"><enum>(v)</enum><text>socioeconomic information on individuals treated in comparable inpatient settings relative to the initiative, including racial and ethnic data, income, housing, geographic proximity to the brick-and-mortar facility and whether such individuals are dually eligible for benefits under this title and title XIX; and</text></clause><clause id="H495E9A347E4A469AB60C990E1F4DA338"><enum>(vi)</enum><text display-inline="yes-display-inline">the quality of care, outcomes, costs, quantity and intensity of services, and other relevant metrics between individuals who entered into the Acute Hospital Care at Home initiative directly from an emergency department compared with individuals who entered into the Acute Hospital Care at Home initiative directly from an existing inpatient stay in a hospital.</text></clause></subparagraph></paragraph><paragraph id="H3BE1E2381F4B428EBB207771E36E243D"><enum>(2)</enum><header>Selection bias</header><text>In conducting the study under paragraph (1), the Secretary shall, to the extent practicable, analyze and compare individuals who participate and do not participate in the initiative controlling for selection bias or other factors that may impact the reliability of data. </text></paragraph><paragraph id="H5FCBF98652A84863AA966DBD498F43E6"><enum>(3)</enum><header>Report</header><text>Not later than September 30, 2028, the Secretary of Health and Human Services shall post on a website of the Centers for Medicare &amp; Medicaid Services a report on the study conducted under paragraph (1).</text></paragraph><paragraph id="H52D6DC52FF0541DCA78DC1103975F2A2" commented="no" display-inline="no-display-inline"><enum>(4)</enum><header>Funding</header><text>In addition to amounts otherwise available, there is appropriated to the Centers for Medicare &amp; Medicaid Services Program Management Account for fiscal year 2025, out of any amounts in the Treasury not otherwise appropriated, $6,000,000, respectively, to remain available until expended, for purposes of carrying out this section.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="H4F34F4E2C43F4F2C881087FB5D5F0078"><enum>212.</enum><header>Enhancing certain program integrity requirements for DME under Medicare</header><subsection id="HB689CEDBD2EA438B83E684DDA335F072"><enum>(a)</enum><header>Durable medical equipment</header><paragraph id="H1B951136107040BCAC7141652DB385A0"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1834(a) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(a)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" id="H9F2F4E199F9349D39833D5AC0CC1366D" display-inline="no-display-inline"><paragraph id="HD3E749A1E8AE441E85A2C4204109D022"><enum>(23)</enum><header>Master List inclusion and claim review for certain items</header><subparagraph id="HE2A430DC367D4986B54A5DEDCFD2E4DE"><enum>(A)</enum><header>Master List inclusion</header><text display-inline="yes-display-inline">Beginning January 1, 2028, for purposes of the Master List described in section 414.234(b) of title 42, Code of Federal Regulations (or any successor regulation), an item for which payment may be made under this subsection shall be treated as having aberrant billing patterns (as such term is used for purposes of such section) if the Secretary determines that, without explanatory contributing factors (such as furnishing emergent care services), a substantial number of claims for such items under this subsection are for such items ordered by a physician or practitioner who has not previously (during a period of not less than 24 months, as established by the Secretary) furnished to the individual involved any item or service for which payment may be made under this title.</text></subparagraph><subparagraph id="H37656411FB58473488168A53F5ACE508"><enum>(B)</enum><header>Claim review</header><text>With respect to items furnished on or after January 1, 2028, that are included on the Master List pursuant to <internal-xref idref="HE2A430DC367D4986B54A5DEDCFD2E4DE" legis-path="(23)(A)">subparagraph (A)</internal-xref>, if such an item is not subject to a determination of coverage in advance pursuant to paragraph (15)(C), the Secretary may conduct prepayment review of claims for payment for such item.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="HC2ACFC63B2EA408A8C049BBF529827E3"><enum>(2)</enum><header>Conforming amendment for prosthetic devices, orthotics, and prosthetics</header><text display-inline="yes-display-inline">Section 1834(h)(3) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(h)(3)</external-xref>) is amended by inserting <quote>, and paragraph (23) of subsection (a) shall apply to prosthetic devices, orthotics, and prosthetics in the same manner as such provision applies to items for which payment may be made under such subsection</quote> before the period at the end.</text></paragraph></subsection><subsection id="HE1D9D91552A14312ACB06DEF8FB659DB"><enum>(b)</enum><header>Report on identifying clinical diagnostic laboratory tests at high risk for fraud and effective mitigation measures</header><text display-inline="yes-display-inline">Not later than January 1, 2026, the Inspector General of the Department of Health and Human Services shall submit to Congress a report assessing fraud risks relating to claims for clinical diagnostic laboratory tests for which payment may be made under section 1834A of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m-1">42 U.S.C. 1395m–1</external-xref>) and effective tools for reducing such fraudulent claims. The report may include information regarding—</text><paragraph id="HA6BDC518326E497E80A56BB21BF2A7DF"><enum>(1)</enum><text>which, if any, clinical diagnostic laboratory tests are identified as being at high risk of fraudulent claims, and an analysis of the factors that contribute to such risk;</text></paragraph><paragraph id="HE6A7874CD7964BFC8FB3CD011FF13581"><enum>(2)</enum><text>with respect to a clinical diagnostic laboratory test identified under paragraph (1) as being at high risk of fraudulent claims—</text><subparagraph id="H3AB160712ECB4D74A481A0C041F853B3" commented="no"><enum>(A)</enum><text>the amount payable under such section 1834A with respect to such test;</text></subparagraph><subparagraph id="HD131F9683844499FB9D14BA25080BFB3"><enum>(B)</enum><text display-inline="yes-display-inline">the number of such tests furnished to individuals enrolled under part B of title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395j">42 U.S.C. 1395j et seq.</external-xref>);</text></subparagraph><subparagraph id="HBE163390E67048BB8556FD85E8A70065"><enum>(C)</enum><text>whether an order for such a test was more likely to come from a provider with whom the individual involved did not have a prior relationship, as determined on the basis of prior payment experience; and</text></subparagraph><subparagraph id="H3B1154A397474293934BE62AC5C4E41E"><enum>(D)</enum><text>the frequency with which a claim for payment under such section 1834A included the payment modifier identified by code 59 or 91; and</text></subparagraph></paragraph><paragraph id="HE05CE67F2AE54F9B9819B25C6AB1B6E0"><enum>(3)</enum><text>suggested strategies for reducing the number of fraudulent claims made with respect to tests so identified as being at high risk, including—</text><subparagraph id="H57BD6269C8BB41B39405C0EAB481ED9A"><enum>(A)</enum><text>an analysis of whether the Centers for Medicare &amp; Medicaid Services can detect aberrant billing patterns with respect to such tests in a timely manner;</text></subparagraph><subparagraph id="H3A78397B06CB4CE281288E6728492C76"><enum>(B)</enum><text>any strategies for identifying and monitoring the providers who are outliers with respect to the number of such tests that such providers order; and</text></subparagraph><subparagraph id="HAE8A16DFAD9247DA899C4931344C638A"><enum>(C)</enum><text>targeted education efforts to mitigate improper billing for such tests; and</text></subparagraph></paragraph><paragraph id="HB40D09887E2040D2979D9DC78B076A67"><enum>(4)</enum><text>such other information as the Inspector General determines appropriate.</text></paragraph></subsection></section><section id="HB3623D07A75E472799380F87BFB51408" display-inline="no-display-inline" section-type="subsequent-section"><enum>213.</enum><header>Guidance on furnishing services via telehealth to individuals with limited English proficiency</header><subsection id="HE9047DD4585942AF920ED3782116EC1F"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of the enactment of this section, the Secretary of Health and Human Services, in consultation with 1 or more entities from each of the categories described in paragraphs (1) through (7) of <internal-xref idref="H7DE2DA08A514412CB3373721C8DB27C1" legis-path="102.(b)">subsection (b)</internal-xref>, shall issue and disseminate, or update and revise as applicable, guidance for the entities described in such subsection on the following:</text><paragraph id="HE1130FA429FB42DD90A9888B19A52715"><enum>(1)</enum><text display-inline="yes-display-inline">Best practices on facilitating and integrating use of interpreters during a telemedicine appointment.</text></paragraph><paragraph id="H5FA98AFDEA6B45FA9C1D71551AE25749"><enum>(2)</enum><text>Best practices on providing accessible instructions on how to access telecommunications systems (as such term is used for purposes of section 1834(m) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)</external-xref>) for individuals with limited English proficiency.</text></paragraph><paragraph id="H3898EDC16EA24091A72AEF747CF56895"><enum>(3)</enum><text>Best practices on improving access to digital patient portals for individuals with limited English proficiency.</text></paragraph><paragraph id="HC8C82D2ACFF943E18E5D7495041BA757"><enum>(4)</enum><text>Best practices on integrating the use of video platforms that enable multi-person video calls furnished via a telecommunications system for purposes of providing interpretation during a telemedicine appointment for an individual with limited English proficiency.</text></paragraph><paragraph id="H3CC836DA758646E5AAC5AB201F04126F"><enum>(5)</enum><text>Best practices for providing patient materials, communications, and instructions in multiple languages, including text message appointment reminders and prescription information.</text></paragraph></subsection><subsection id="H7DE2DA08A514412CB3373721C8DB27C1"><enum>(b)</enum><header>Entities described</header><text>For purposes of <internal-xref idref="HE9047DD4585942AF920ED3782116EC1F" legis-path="102.(a)">subsection (a)</internal-xref>, an entity described in this subsection is an entity in 1 or more of the following categories:</text><paragraph id="H6F094795A936460DB75D5581BC69C7A0"><enum>(1)</enum><text display-inline="yes-display-inline">Health information technology service providers, including—</text><subparagraph id="H5DED67A9F5B44B65850DE393BDC8D95B"><enum>(A)</enum><text>electronic medical record companies;</text></subparagraph><subparagraph id="HEC3865A0F91C432CA747EB497D030D7A"><enum>(B)</enum><text>remote patient monitoring companies; and</text></subparagraph><subparagraph id="HE9BBDC1BCB1B40CCAEC0D5A5EF054B3F"><enum>(C)</enum><text>telehealth or mobile health vendors and companies.</text></subparagraph></paragraph><paragraph id="H5D486709ADE04D3793E7FA7394BB6901"><enum>(2)</enum><text>Health care providers, including—</text><subparagraph id="H26DB52A78C69421B9293D3905BC97602"><enum>(A)</enum><text>physicians; and</text></subparagraph><subparagraph id="H590622B428BA4CAEB65C5EAC60DF28C6"><enum>(B)</enum><text>hospitals.</text></subparagraph></paragraph><paragraph id="H97A3E0B6BDC8418CADA3318481938383"><enum>(3)</enum><text>Health insurers.</text></paragraph><paragraph id="H54214C9C9134449E9EE9D25B20935F27"><enum>(4)</enum><text>Language service companies.</text></paragraph><paragraph id="H8ABA24E8CD5446DBA77C03402285F5F6"><enum>(5)</enum><text>Interpreter or translator professional associations.</text></paragraph><paragraph id="HE31FFCA815064CAAA3F80A88F8AA0C0F"><enum>(6)</enum><text>Health and language services quality certification organizations.</text></paragraph><paragraph id="HA39BFF464D52495D8A922B3C306F5FB3"><enum>(7)</enum><text>Patient and consumer advocates, including such advocates that work with individuals with limited English proficiency.</text></paragraph></subsection></section><section id="HAF33887A75D44AA8AEAA8FA43B4F9263" display-inline="no-display-inline" section-type="subsequent-section"><enum>214.</enum><header>In-home cardiopulmonary rehabilitation flexibilities</header><subsection id="HB689281FB4384FD08F05177A1F73D3E2"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1861(eee)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(eee)(2)</external-xref>) is amended—</text><paragraph id="H99DC73E8ED9A4E47A39731F75DCEB1D9"><enum>(1)</enum><text>in subparagraph (A)(ii), by inserting <quote>(including, with respect to items and services furnished through audio and video real-time communications technology (excluding audio-only) on or after April 1, 2025, and before January 1, 2027, in the home of an individual who is an outpatient of the hospital)</quote> after <quote>outpatient basis</quote>; and</text></paragraph><paragraph id="H9C9828EBF1B949D0A3A98C1214467952"><enum>(2)</enum><text>in subparagraph (B), by inserting <quote>(including, with respect to items and services furnished through audio and video real-time communications technology on or after April 1, 2025, and before January 1, 2027, the virtual presence of such physician, physician assistant, nurse practitioner, or clinical nurse specialist)</quote> after <quote>under the program</quote>.</text></paragraph></subsection><subsection id="H5FB31632275144208A1C173F1EC2E716"><enum>(b)</enum><header>Program instruction authority</header><text>Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by this section by program instruction or otherwise.</text></subsection></section><section id="HAFDA9A06CBC142A29ED1D77BDED1AA96" display-inline="no-display-inline" section-type="subsequent-section"><enum>215.</enum><header>Inclusion of virtual diabetes prevention program suppliers in MDPP Expanded Model</header><subsection id="HDD1D5268C6114516B64EC5BA68806C93"><enum>(a)</enum><header>In general</header><text>Not later than January 1, 2026, the Secretary shall revise the regulations under parts 410 and 424 of title 42, Code of Federal Regulations, to provide that, for the period beginning January 1, 2026, and ending December 31, 2030—</text><paragraph id="H37E8A8762E5843A9870FD7325664AD91"><enum>(1)</enum><text display-inline="yes-display-inline">an entity may participate in the MDPP by offering only online MDPP services via synchronous or asynchronous technology or telecommunications if such entity meets the conditions for enrollment as an MDPP supplier (as specified in section 424.205(b) of title 42, Code of Federal Regulations (or a successor regulation));</text></paragraph><paragraph id="H436FE750AEDA4C4C84999A642CEEB48D"><enum>(2)</enum><text>if an entity participates in the MDPP in the manner described in <internal-xref idref="H37E8A8762E5843A9870FD7325664AD91" legis-path="2.(a)(1)">paragraph (1)</internal-xref>—</text><subparagraph id="HAB5A8B2848474850AF42F05DDC7FB69D" display-inline="no-display-inline"><enum>(A)</enum><text>the administrative location of such entity shall be the address of the entity on file under the Diabetes Prevention Recognition Program; and</text></subparagraph><subparagraph id="HDF70B006470648E2B548BD46CB4271DD"><enum>(B)</enum><text>in the case of online MDPP services furnished by such entity to an MDPP beneficiary who was not located in the same State as the entity at the time such services were furnished, the entity shall not be prohibited from submitting a claim for payment for such services solely by reason of the location of such beneficiary at such time; and</text></subparagraph></paragraph><paragraph id="HC578F9ADB3014A5DBD582EB629E3DB28"><enum>(3)</enum><text>no limit is applied on the number of times an individual may enroll in the MDPP.</text></paragraph></subsection><subsection id="H2F554124C29F480FBC1F35B3273A92E9"><enum>(b)</enum><header>Definitions</header><text>In this section:</text><paragraph id="H320DD5189A394D0989C76DB83290B23C" commented="no"><enum>(1)</enum><header>MDPP</header><text display-inline="yes-display-inline">The term <term>MDPP</term> means the Medicare Diabetes Prevention Program conducted under section 1115A of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1315a">42 U.S.C. 1315a</external-xref>), as described in the final rule published in the Federal Register entitled <quote>Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program</quote> (88 Fed. Reg. 78818 (November 16, 2023)) (or a successor regulation).</text></paragraph><paragraph id="HE07955547A164C64BF45FC94858DA5A5" commented="no"><enum>(2)</enum><header>Regulatory terms</header><text>The terms <term>Diabetes Prevention Recognition Program</term>, <term>full CDC DPRP recognition</term>, <term>MDPP beneficiary</term>, <term>MDPP services</term>, and <term>MDPP supplier</term> have the meanings given each such term in section 410.79(b) of title 42, Code of Federal Regulations.</text></paragraph><paragraph id="HBF99AB43794F4BB0A12B37BE97152E96"><enum>(3)</enum><header>Secretary</header><text>The term <term>Secretary</term> means the Secretary of Health and Human Services.</text></paragraph></subsection></section><section id="H5BB54C35666040A4951E67BF580F00C3" commented="no"><enum>216.</enum><header>Medication-induced movement disorder outreach and education</header><text display-inline="no-display-inline">Not later than January 1, 2026, the Secretary shall use existing communications mechanisms to provide education and outreach to physicians and appropriate non-physician practitioners participating under the Medicare program under title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395">42 U.S.C. 1395 et seq.</external-xref>) with respect to periodic screening for medication-induced movement disorders that are associated with the treatment of mental health disorders in at-risk patients, as well as resources related to clinical guidelines and best practices for furnishing such screening services through telehealth. Such education and outreach shall include information on how to account for such screening services in evaluation and management code selection. The Secretary shall, to the extent practicable, seek input from relevant stakeholders to inform such education and outreach. Such education and outreach may also address other relevant screening services furnished through telehealth, as the Secretary determines appropriate.</text></section><section id="H50C1A5BF09DF4FD683EB94F6CD890F94" commented="no"><enum>217.</enum><header>Report on wearable medical devices</header><text display-inline="no-display-inline">Not later than 18 months after the date of the enactment of this Act, the Comptroller General of the United States shall conduct a technology assessment of, and submit to Congress a report on, the capabilities and limitations of wearable medical devices used to support clinical decision-making. Such report shall include a description of—</text><paragraph id="H1F0DE9F9F6DB4FAE958AD94AD8E4401A" commented="no"><enum>(1)</enum><text>the potential for such devices to accurately prescribe treatments;</text></paragraph><paragraph id="H0B4A0D30BAF64927AE20B5484BCBDD2D" commented="no"><enum>(2)</enum><text>an examination of the benefits and challenges of artificial intelligence to augment such capabilities; and</text></paragraph><paragraph id="H4803EAC3898E412EB3D7E74811B8204C" commented="no"><enum>(3)</enum><text>policy options to enhance the benefits and mitigate potential challenges of developing or using such devices.</text></paragraph></section><section id="H98BBF63A9CDF40029FBFD0445DBBB63A"><enum>218.</enum><header>Extension of temporary inclusion of authorized oral antiviral drugs as covered part D drugs</header><text display-inline="no-display-inline">Section 1860D–2(e)(1)(C) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-102">42 U.S.C. 1395w–102(e)(1)(C)</external-xref>) is amended by striking <quote>March 31, 2025</quote> and inserting <quote>December 31, 2025</quote>.</text></section><section section-type="subsequent-section" id="H2811D91DBFD14E5690700F86C66C5B1B" display-inline="no-display-inline"><enum>219.</enum><header>Extension of adjustment to calculation of hospice cap amount</header><text display-inline="no-display-inline">Section 1814(i)(2)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395f">42 U.S.C. 1395f(i)(2)(B)</external-xref>) is amended—</text><paragraph id="HA887EA83210545A7965B0B50A164842A"><enum>(1)</enum><text>in clause (ii), by striking <quote>2033</quote> and inserting <quote>2034</quote>; and</text></paragraph><paragraph id="HE6A550625B8444DBA1EAF5C0A238132F" commented="no" display-inline="no-display-inline"><enum>(2)</enum><text>in clause (iii), by striking <quote>2033</quote> and inserting <quote>2034</quote>. </text></paragraph></section><section id="H072728C94404481DB043F074751F982B" section-type="subsequent-section" display-inline="no-display-inline"><enum>220.</enum><header>Multiyear contracting authority for MedPAC and MACPAC</header><text display-inline="no-display-inline">Section 3904 of title 41, United States Code, is amended by adding at the end the following new subsections:</text><quoted-block style="OLC" id="H78475DD137F94E3AB691A20DFEA94CBC" display-inline="no-display-inline"><subsection id="HA42741DC81194D60B6B739DB2E49B88D"><enum>(i)</enum><header>The Medicare Payment Advisory Commission</header><text display-inline="yes-display-inline">The Medicare Payment Advisory Commission may use available funds to enter into contracts for the procurement of severable services for a period that begins in one fiscal year and ends in the next fiscal year and may enter into multiyear contracts for the acquisition of property and services to the same extent as executive agencies under the authority of sections 3902 and 3903 of this title.</text></subsection><subsection id="HC0A910FA5740420798EFDB7D4E20F2A2"><enum>(j)</enum><header>The Medicaid and CHIP Payment and Access Commission</header><text display-inline="yes-display-inline">The Medicaid and CHIP Payment and Access Commission may use available funds to enter into contracts for the procurement of severable services for a period that begins in one fiscal year and ends in the next fiscal year and may enter into multiyear contracts for the acquisition of property and services to the same extent as executive agencies under the authority of sections 3902 and 3903 of this title.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="HD9294B91DEF7421CB74DCD45ABFBC1AF" section-type="subsequent-section" display-inline="no-display-inline"><enum>221.</enum><header>Contracting parity for MedPAC and MACPAC</header><text display-inline="no-display-inline">In fiscal year 2025 and thereafter, for all contracts for goods and services to which the Medicare and Payment Advisory Commission or the Medicaid and CHIP Payment and Access Commission is a party, the following Federal Acquisition Regulation (FAR) clauses will apply: FAR 52.232–39 and FAR 52.233–4 (or a successor clause).</text></section><section id="HF7338FDDF8544438B9EF61E0A733C588" display-inline="no-display-inline"><enum>222.</enum><header>Adjustments to Medicare part D cost-sharing reductions for low-income individuals</header><text display-inline="no-display-inline">Section 1860D–14(a) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-114">42 U.S.C. 1395w–114(a)</external-xref>) is amended—</text><paragraph id="HD08B7BF460194B8E97C426DDE0E63FA2"><enum>(1)</enum><text>in paragraph (1)(D)(ii), by striking <quote>that does not exceed $1 for</quote> and all that follows through the period at the end and inserting</text><quoted-block display-inline="yes-display-inline" id="HE381391FD81F4351A514AFA43410120A" style="OLC"><text>that does not exceed—</text><subclause id="H65297A1EA9C1489689684349BFADD217"><enum>(I)</enum><text display-inline="yes-display-inline">for a plan year before 2027—</text><item id="H222C44EA66364C7D80D79D83C9B987DB"><enum>(aa)</enum><text display-inline="yes-display-inline">for a generic drug or a preferred drug that is a multiple source drug (as defined in section 1927(k)(7)(A)(i)), $1 or, if less, the copayment amount applicable to an individual under clause (iii); and</text></item><item id="H8654DB9B05F2480EB395A52C124A8B8E"><enum>(bb)</enum><text>for any other drug, $3 or, if less, the copayment amount applicable to an individual under clause (iii); and</text></item></subclause><subclause id="HBB7F432823414F70A2BCFE68E9FB84D4"><enum>(II)</enum><text display-inline="yes-display-inline">for plan year 2027 and each subsequent plan year—</text><item id="H508EB88A792942D4B877CC3CC9AC3E95"><enum>(aa)</enum><text>for a generic drug, $0;</text></item><item id="H6D3BDDFEB017480A82EB7228328F6121" commented="no"><enum>(bb)</enum><text display-inline="yes-display-inline">for a preferred drug that is a multiple source drug (as defined in section 1927(k)(7)(A)(i)), the dollar amount applied under this clause for such a drug for the preceding plan year, increased by the annual percentage increase in the consumer price index (all items; U.S. city average) as of September of such preceding year, or, if less, the copayment amount applicable to an individual under clause (iii); and</text></item><item id="HAFDFB57981284A86BE7F18BC2016D81B"><enum>(cc)</enum><text display-inline="yes-display-inline">for a drug not described in either item (aa) or (bb), the dollar amount applied under this clause for such a drug for the preceding plan year, increased in the manner specified in item (bb), or, if less, the copayment amount applicable to an individual under clause (iii).</text></item></subclause><quoted-block-continuation-text quoted-block-continuation-text-level="clause">Any amount established under item (bb) or (cc) of subclause (II), that is based on an increase of $1 or $3, that is not a multiple of 5 cents or 10 cents, respectively, shall be rounded to the nearest multiple of 5 cents or 10 cents, respectively.</quoted-block-continuation-text><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="HBB0A4BC002884BCF8CF983CFF3B09177"><enum>(2)</enum><text>in paragraph (4)(A)(ii), by inserting <quote>(before 2027)</quote> after <quote>a subsequent year</quote>. </text></paragraph></section><section id="H8FEECB3D10294FA9BCF0BED9F87FA3F4"><enum>223.</enum><header>Requiring Enhanced and Accurate Lists of (REAL) Health Providers Act</header><subsection commented="no" display-inline="no-display-inline" id="HB9860BCCF7A843929DF6B8F1DC6FBCBD"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 1852(c) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-22">42 U.S.C. 1395w–22(c)</external-xref>) is amended—</text><paragraph commented="no" id="H75E6D21F3FD8456BAAF3CCE7D8CEA374"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1)(C)—</text><subparagraph commented="no" id="HE12832FB35604C9D9CB28FCE335D965D"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>plan, and any</quote> and inserting <quote>plan, any</quote>; and</text></subparagraph><subparagraph commented="no" id="HEA1459ECD0F5437F9CF8C456D7244A62"><enum>(B)</enum><text>by inserting the following before the period at the end: <quote>, and, in the case of a specified MA plan (as defined in paragraph (3)(C)), for plan year 2027 and subsequent plan years, the information described in paragraph (3)(B)</quote>; and</text></subparagraph></paragraph><paragraph commented="no" id="H27F2B0B73AC741D29CC442D6A5BD70E0"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H48A34440EBB745B1AC304A242D926358"><paragraph commented="no" id="H85BCF5ED09344391B576981D204F8C98"><enum>(3)</enum><header>Provider directory accuracy</header><subparagraph commented="no" id="H54C16AEE619942C6A1C4E8108E74DCD6"><enum>(A)</enum><header>In general</header><text>For plan year 2027 and subsequent plan years, each MA organization offering a specified MA plan (as defined in subparagraph (C)) shall, for each such plan offered by the organization—</text><clause id="H52FB4B968E4944BABB89AC8C4BFC8489"><enum>(i)</enum><text>maintain, on a publicly available internet website, an accurate provider directory that includes the information described in subparagraph (B);</text></clause><clause commented="no" display-inline="no-display-inline" id="H19FE668C9F30419C909C64A8EC9C0329"><enum>(ii)</enum><text display-inline="yes-display-inline">not less frequently than once every 90 days (or, in the case of a hospital or any other facility determined appropriate by the Secretary, at a lesser frequency specified by the Secretary but in no case less frequently than once every 12 months), verify the provider directory information of each provider listed in such directory and, if applicable, update such provider directory information;</text></clause><clause commented="no" display-inline="no-display-inline" id="H2379085855994344B8B95D2942035DAC"><enum>(iii)</enum><text display-inline="yes-display-inline">if the organization is unable to verify such information with respect to a provider, include in such directory an indication that the information of such provider may not be up to date; and</text></clause><clause commented="no" display-inline="no-display-inline" id="HBF06C5CB81D74425AF381100CEFBEE70"><enum>(iv)</enum><text display-inline="yes-display-inline">remove a provider from such directory within 5 business days if the organization determines that the provider is no longer a provider participating in the network of such plan.</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H28EC1B67B6BA496A96B0014581CEDC2D"><enum>(B)</enum><header>Provider directory information</header><text display-inline="yes-display-inline">The information described in this subparagraph is information enrollees may need to access covered benefits from a provider with which such organization offering such plan has an agreement for furnishing items and services covered under such plan such as name, specialty, contact information, primary office or facility address, whether the provider is accepting new patients, accommodations for people with disabilities, cultural and linguistic capabilities, and telehealth capabilities.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7590C8FBF8DC4ECAB0E2829DA4DEC51B"><enum>(C)</enum><header>Specified MA plan</header><text display-inline="yes-display-inline">In this paragraph, the term <term>specified MA plan</term> means—</text><clause commented="no" display-inline="no-display-inline" id="H1DA7D4221EF24F4AB560F9F1DFCB4EFB"><enum>(i)</enum><text display-inline="yes-display-inline">a network-based plan (as defined in subsection (d)(5)(C)); or</text></clause><clause commented="no" display-inline="no-display-inline" id="H27568FD21FF84DB5906D85DB546A1734"><enum>(ii)</enum><text display-inline="yes-display-inline">a Medicare Advantage private fee-for-service plan (as defined in section 1859(b)(2)) that meets the access standards under subsection (d)(4), in whole or in part, through entering into contracts or agreements as provided for under subparagraph (B) of such subsection.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HF64E0B8A401C4B49A1196C5A7CC69FCC"><enum>(b)</enum><header>Accountability for provider directory accuracy</header><paragraph id="H6F3385ABA82641A2A79548DC5E8ED12D"><enum>(1)</enum><header>Cost Sharing for Services Furnished Based on Reliance on Incorrect Provider directory Information</header><text display-inline="yes-display-inline">Section 1852(d) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-22">42 U.S.C. 1395w–22(d)</external-xref>) is amended—</text><subparagraph commented="no" display-inline="no-display-inline" id="H1527380E364945CD9F6032AE91E8CD0C"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)(C)—</text><clause commented="no" display-inline="no-display-inline" id="H8BE093C941CF4A70B2A5E6314560B7FD"><enum>(i)</enum><text>in clause (ii), by striking <quote>or</quote> at the end;</text></clause><clause commented="no" display-inline="no-display-inline" id="H65260E1E73D3422EB448AE36A720D147"><enum>(ii)</enum><text>in clause (iii), by striking the semicolon at the end and inserting <quote>, or</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H2F6BC94D573D4029900BA495923EB6D3"><enum>(iii)</enum><text>by adding at the end the following new clause:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H7F7E2C797B8E475495D3A0979324D7FB"><clause commented="no" display-inline="no-display-inline" id="HD1648B80DC6A4E29BF1A026330B4ED78"><enum>(iv)</enum><text>the services are furnished by a provider that is not participating in the network of a specified MA plan (as defined in subsection (c)(3)(C)) but is listed in the provider directory of such plan on the date on which the appointment is made, as described in paragraph (7)(A);</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H54C0BBE684A54B79B3CB7A0C8EDF3C39"><enum>(B)</enum><text display-inline="yes-display-inline">by adding at the end the following new paragraph:</text><quoted-block id="HFCE9E54B32DE44BCA3FA3B5A890041B5" display-inline="no-display-inline" style="OLC"><paragraph id="H96E5478480354CD8BBD59C224865E980"><enum>(7)</enum><header>Cost sharing for services furnished based on reliance on incorrect provider directory information</header><subparagraph id="H85D370F7D5834DCD87C619DBBB2CF2C3"><enum>(A)</enum><header>In general</header><text>For plan year 2027 and subsequent plan years, if an enrollee is furnished an item or service by a provider that is not participating in the network of a specified MA plan (as defined in subsection (c)(3)(C)) but is listed in the provider directory of such plan (as required to be provided to an enrollee pursuant to subsection (c)(1)(C)) on the date on which the appointment is made, and if such item or service would otherwise be covered under such plan if furnished by a provider that is participating in the network of such plan, the MA organization offering such plan shall ensure that the enrollee is only responsible for the lesser of—</text><clause commented="no" display-inline="no-display-inline" id="H2083BECA4B6940038032D8D023C61D60"><enum>(i)</enum><text display-inline="yes-display-inline">the amount of cost sharing that would apply if such provider had been participating in the network of such plan; or</text></clause><clause commented="no" display-inline="no-display-inline" id="HB5EA239B321B4245A809406C4E9DB56B"><enum>(ii)</enum><text>the amount of cost sharing that would otherwise apply (without regard to this subparagraph).</text></clause></subparagraph><subparagraph id="HFDC6A027F75547FC8B8CC87F76729A1A"><enum>(B)</enum><header>Notification requirement</header><text>For plan year 2027 and subsequent plan years, each MA organization that offers a specified MA plan shall—</text><clause commented="no" display-inline="no-display-inline" id="H4B719FFFF9244A279B17736C9EB33C60"><enum>(i)</enum><text display-inline="yes-display-inline">notify enrollees of their cost-sharing protections under this paragraph and make such notifications, to the extent practicable, by not later than the first day of an annual, coordinated election period under section 1851(e)(3) with respect to a year; </text></clause><clause commented="no" display-inline="no-display-inline" id="HEDF56156FE274F60B9ABFCE3869769CA"><enum>(ii)</enum><text display-inline="yes-display-inline">include information regarding such cost-sharing protections in the provider directory of each specified MA plan offered by the MA organization.; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H636DC144454C4720AA25696628A92D9F"><enum>(iii)</enum><text display-inline="yes-display-inline">notify enrollees of their cost-sharing protections under this paragraph in an explanation of benefits.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="HAD4BDBA3B1304F9F80830450EA84CA9B"><enum>(2)</enum><header>Required provider directory accuracy analysis and reports</header><subparagraph commented="no" display-inline="no-display-inline" id="HC8C73A8F4A1D4851923F5EEC5114C772"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text>Section 1857(e) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-27">42 U.S.C. 1395w–27(e)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HB79C02A9DE3A4CEC8A6FE6B0AA99E86D"><paragraph commented="no" display-inline="no-display-inline" id="H94F18D7409C54E93B3976BEB478C68CD"><enum>(6)</enum><header>Provider directory accuracy analysis and reports</header><subparagraph commented="no" display-inline="no-display-inline" id="H400DF284127246F4980E800A1F317E0B"><enum>(A)</enum><header>In general</header><text>Beginning with plan years beginning on or after January 1, 2027, subject to subparagraph (C), a contract under this section with an MA organization shall require the organization, for each specified MA plan (as defined in section 1852(c)(3)(C)) offered by the organization to annually do the following:</text><clause commented="no" display-inline="no-display-inline" id="H37E676136C324D11B53B2AF4E219E160"><enum>(i)</enum><text display-inline="yes-display-inline">Conduct an analysis estimating the accuracy of the provider directory information of such plan using a random sample of providers included in such provider directory as follows:</text><subclause commented="no" display-inline="no-display-inline" id="HA98C0855EAB8481EAF8D629A788A44D6"><enum>(I)</enum><text display-inline="yes-display-inline">Such a random sample shall include a random sample of each specialty of providers with a high inaccuracy rate of provider directory information relative to other specialties of providers, as determined by the Secretary.</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H173D115B56AC450E9FC4F5C1561D83E5"><enum>(II)</enum><text>For purposes of subclause (I), one type of specialty may be providers specializing in mental health or substance use disorder treatment.</text></subclause></clause><clause id="H58C71D2793CC454186BC3FC18E74CE22"><enum>(ii)</enum><text>Submit to the Secretary a report containing the results of the analysis conducted under clause (i), including an accuracy score for such provider directory information (as determined using a plan verification method specified by the Secretary under subparagraph (B)(i)).</text></clause></subparagraph><subparagraph id="H9F33277BCE8342158BF50AA2FEB9C753"><enum>(B)</enum><header>Determination of accuracy score</header><clause id="H2FA7FE6F84E34984B8C7EF6C1C42D31F"><enum>(i)</enum><header>In general</header><text>The Secretary shall specify plan verification methods, such as using telephonic verification or other approaches using data sources maintained by an MA organization or using publicly available data sets, that MA organizations may use for estimating accuracy scores of the provider directory information of specified MA plans offered by such organizations.</text></clause><clause id="H77A5035AD2664FE5AD4B09AAE495A8A8"><enum>(ii)</enum><header>Accuracy score methodology</header><text>With respect to each such method specified by the Secretary as described in clause (i), the Secretary shall specify a methodology for MA organizations to use in estimating such accuracy scores. Each such methodology shall take into account the administrative burden on plans and providers and the relative importance of certain provider directory information on enrollee ability to access care.</text></clause></subparagraph><subparagraph id="HC0F7965AD2D64114ABF52D8EEF70CCE3"><enum>(C)</enum><header>Exception</header><text>The Secretary may waive the requirements of this paragraph in the case of a specified MA plan with low enrollment (as defined by the Secretary).</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF0AA4C447B18497587C0A96ACF46A9F9"><enum>(D)</enum><header>Transparency</header><text>Beginning with plan years beginning on or after January 1, 2028, the Secretary shall post accuracy scores (as reported under subparagraph (A)(ii)), in a machine readable file, on the internet website of the Centers for Medicare &amp; Medicaid Services.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph><subparagraph id="HB5D3A3E106464E75A44D153F28708710" commented="no"><enum>(B)</enum><header>Provision of information to beneficiaries</header><text>Section 1851(d)(4) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-21">42 U.S.C. 1395w–21(d)(4)</external-xref>) is amended by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HA539DD48C6A042EF9E9581BA9DFC27E1"><subparagraph commented="no" display-inline="no-display-inline" id="HB3CFF0D3DC03457CADF672355A630F80"><enum>(F)</enum><header>Provider Directory</header><text display-inline="yes-display-inline">Beginning with plan years beginning on or after January 1, 2028, the accuracy score of the plan’s provider directory (as reported under section 1857(e)(6)(A)(ii)) listed prominently on the plan’s provider directory.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF342334E2B2F4DB19BCBF46045C8C282"><enum>(C)</enum><header>Funding</header><text>In addition to amounts otherwise available, there is appropriated to the Centers for Medicare &amp; Medicaid Services Program Management Account, out of any money in the Treasury not otherwise appropriated, $4,000,000 for fiscal year 2025, to remain available until expended, to carry out the amendments made by this paragraph.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H26A4573BBD57434C8E124FEDE24708C8"><enum>(3)</enum><header>GAO study and report</header><subparagraph commented="no" display-inline="no-display-inline" id="H09899F2A5A4944209422F54FE3573F03"><enum>(A)</enum><header display-inline="yes-display-inline">Analysis</header><text>The Comptroller General of the United States (in this paragraph referred to as the <quote>Comptroller General</quote>) shall conduct a study of the implementation of the amendments made by paragraphs (1) and (2). To the extent data are available and reliable, such study shall include an analysis of—</text><clause id="H9A21E9C26BA24345A80907DB156494A7"><enum>(i)</enum><text>the use of cost-sharing protections required under section 1852(d)(7)(A) of the Social Security Act, as added by paragraph (1);</text></clause><clause id="HD3FACE2B6F7E499595DBCCBC6A091EE8"><enum>(ii)</enum><text>the trends in provider directory information accuracy scores under section 1857(e)(6)(A)(ii) of the Social Security Act (as added by paragraph (2)(A)), both overall and among providers specializing in mental health or substance use disorder treatment;</text></clause><clause commented="no" display-inline="no-display-inline" id="HA84E36BE92924A4898F144D25907D0A9"><enum>(iii)</enum><text display-inline="yes-display-inline">provider response rates by plan verification methods; </text></clause><clause commented="no" display-inline="no-display-inline" id="HFA0CE99D9342460F8106A8BA20C7B1E6"><enum>(iv)</enum><text display-inline="yes-display-inline">administrative costs to providers and Medicare Advantage organizations; and</text></clause><clause id="H51726376DE564254BE4C7059C95E17B7"><enum>(v)</enum><text>other items determined appropriate by the Comptroller General.</text></clause></subparagraph><subparagraph id="HE57ECF7C4E504240A615B24B961E08A9" commented="no" display-inline="no-display-inline"><enum>(B)</enum><header display-inline="yes-display-inline">Report</header><text>Not later than January 15, 2032, the Comptroller General shall submit to Congress a report containing the results of the study conducted under subparagraph (A), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate. </text></subparagraph></paragraph></subsection><subsection id="H25000BBCBBF54C0DA5F0807D7F6AE619"><enum>(c)</enum><header>Guidance on maintaining accurate provider directories</header><paragraph commented="no" display-inline="no-display-inline" id="H6FF96F52D790477B87FCAD390B3648D8"><enum>(1)</enum><header display-inline="yes-display-inline">Stakeholder meeting</header><subparagraph commented="no" display-inline="no-display-inline" id="H3674B2CEE9CA4D8DBC3065BBA0C1CAB8"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text>Not later than 3 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the <term>Secretary</term>) shall hold a public meeting to receive input on approaches for maintaining accurate provider directories for Medicare Advantage plans under part C of title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-21">42 U.S.C. 1395w–21 et seq.</external-xref>), including input on approaches for reducing administrative burden, such as data standardization, and best practices to maintain accurate provider directory information.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDE1D2B6359A44F188CDAFB2040292CC5"><enum>(B)</enum><header>Participants</header><text display-inline="yes-display-inline">Participants of the meeting under subparagraph (A) shall include representatives from the Centers for Medicare &amp; Medicaid Services and the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology. Such meeting shall be open to the public. To the extent practicable, the Secretary shall include health care providers, companies that specialize in relevant technologies, health insurers, and patient advocates.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HAAC87023AE794EEA9D2F510A8E0E8D62"><enum>(2)</enum><header display-inline="yes-display-inline">Guidance to Medicare Advantage organizations</header><text display-inline="yes-display-inline">Not later than 12 months after the date of enactment of this Act, the Secretary shall issue guidance to Medicare Advantage organizations offering Medicare Advantage plans under part C of title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-21">42 U.S.C. 1395w–21 et seq.</external-xref>) on maintaining accurate provider directories for such plans, taking into consideration input received during the stakeholder meeting under paragraph (1). Such guidance may include the following, as determined appropriate by the Secretary:</text><subparagraph commented="no" display-inline="no-display-inline" id="H7BF70D86E1244A30822313ECB09625B5"><enum>(A)</enum><text display-inline="yes-display-inline">Best practices for Medicare Advantage organizations on how to work with providers to maintain the accuracy of provider directories and reduce provider and Medicare Advantage organization burden with respect to maintaining the accuracy of provider directories.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDF7D985EF08C4EAE88F18FA46F58E97A"><enum>(B)</enum><text display-inline="yes-display-inline">Information on data sets and data sources with information that could be used by Medicare Advantage organizations to maintain accurate provider directories.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H6838C8930B974E48853701504DB66BCB"><enum>(C)</enum><text display-inline="yes-display-inline">Approaches for utilizing data sources maintained by Medicare Advantage organizations and publicly available data sets to maintain accurate provider directories.</text></subparagraph><subparagraph id="H8494B6D68D5749B6AEB36B62EFA09967" commented="no" display-inline="no-display-inline"><enum>(D)</enum><text display-inline="yes-display-inline">Information to be included in provider directories that may be useful for Medicare beneficiaries to assess plan networks when selecting a plan and accessing providers participating in plan networks during the plan year.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H348102AE749E480EBA966606BEF9E60D"><enum>(3)</enum><header>Guidance to part B providers</header><text>Not later than 12 months after the date of enactment of this Act, the Secretary shall issue guidance to providers of services and suppliers who furnish items or services for which benefits are available under part B of title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395j">42 U.S.C. 1395j et seq.</external-xref>) on when to update the National Plan and Provider Enumeration System for information changes. </text></paragraph></subsection></section><section id="HE4D119B4212A4EC0ADC0BCE4EB5D1E1D"><enum>224.</enum><header>Medicare coverage of multi-cancer early detection screening tests</header><subsection id="H79A264C704254E7FAB5F990EEECDD597"><enum>(a)</enum><header>Coverage</header><text>Section 1861 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x</external-xref>) is amended—</text><paragraph id="H3BF837C62ADA43BC92B8BA2900386B2F"><enum>(1)</enum><text>in subsection (s)(2)—</text><subparagraph id="H09463239BCE74B1E923C92A091ADC751"><enum>(A)</enum><text>by striking the semicolon at the end of subparagraph (JJ) and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph id="HF0C2652BAF984527B6DC822D990C2F2A"><enum>(B)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block id="H305A3256F67C4DDC86247F239371541E" style="OLC"><subparagraph id="H9AFA31B0F34C4B80B7E86926C7887E89"><enum>(KK)</enum><text>multi-cancer early detection screening tests (as defined in subsection (nnn));</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H7881DBD610AF4EC59F73A796082FBEE5"><enum>(2)</enum><text>by adding at the end the following new subsection:</text><quoted-block id="HE9A85494AF014747900258ADA912AB2B" style="OLC"><subsection id="HEE6306A3FDA04D9596CF2D7F2C140A7F"><enum>(nnn)</enum><header>Multi-Cancer early detection screening tests</header><paragraph id="HD615AD046ABC4000A9E0A9A6C5559CFD"><enum>(1)</enum><header>In general</header><text>The term <term>multi-cancer early detection screening test</term> means a test furnished to an individual for the concurrent detection of multiple cancer types across multiple organ sites on or after January 1, 2029, that—</text><subparagraph id="H41833B152DC745609FA393805954E889"><enum>(A)</enum><text>is cleared under section 510(k), classified under section 513(f)(2), or approved under section 515 of the Federal Food, Drug, and Cosmetic Act;</text></subparagraph><subparagraph id="HC3F4F5675147447BB1E2FD78E02EA8E8"><enum>(B)</enum><text>is—</text><clause id="HF9DB4215447E43788240D68DA3C03F04"><enum>(i)</enum><text>a genomic sequencing blood or blood product test that includes the analysis of cell-free nucleic acids; or</text></clause><clause id="H947A8DB2E5CF4D488E51ED075A3424AF"><enum>(ii)</enum><text>a test based on samples of biological material that provide results comparable to those obtained with a test described in <internal-xref idref="HF9DB4215447E43788240D68DA3C03F04" legis-path="(nnn)(1)(B)(i)">clause (i)</internal-xref>, as determined by the Secretary; and</text></clause></subparagraph><subparagraph id="H70C4BA2500A143308605EEE42311E22D"><enum>(C)</enum><text display-inline="yes-display-inline">the Secretary determines is—</text><clause id="HC1321F71806949C4A904A703AFD380FD"><enum>(i)</enum><text>reasonable and necessary for the prevention or early detection of an illness or disability; and</text></clause><clause id="H03F8D1162DC24DF88A49C1CC24FEC486"><enum>(ii)</enum><text display-inline="yes-display-inline">appropriate for individuals entitled to benefits under part A or enrolled under part B.</text></clause></subparagraph></paragraph><paragraph id="HCE873C12DD574E02BAFDB1666FD91E11"><enum>(2)</enum><header>NCD process</header><text display-inline="yes-display-inline">In making determinations under paragraph (1)(C) regarding the coverage of a new test, the Secretary shall use the process for making national coverage determinations (as defined in section 1869(f)(1)(B)) under this title.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H9FB457646DDD4D8FB108CED72D3BB7BE"><enum>(b)</enum><header>Payment and standards for multi-Cancer early detection screening tests</header><paragraph id="H204E2F35924F486E8CA336585372C0C9"><enum>(1)</enum><header>In general</header><text>Section 1834 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m</external-xref>) is amended by adding at the end the following new subsection:</text><quoted-block style="OLC" id="H21452D5D75C948168690F88BABF149F7" display-inline="no-display-inline"><subsection id="H3D3722BA5E5E4CEC92DBF69A29DAB8C9"><enum>(aa)</enum><header>Payment and standards for multi-Cancer early detection screening tests</header><paragraph id="H9FADEDDBA26F450BBD83BDDCBC1A1385"><enum>(1)</enum><header>Payment amount</header><text>The payment amount for a multi-cancer early detection screening test (as defined in section 1861(nnn)) is—</text><subparagraph id="HFAE299AA66714012B84880A524787050"><enum>(A)</enum><text>with respect to such a test furnished before January 1, 2031, equal to the payment amount in effect on the date of the enactment of this subsection for a multi-target stool screening DNA test covered pursuant to section 1861(pp)(1)(D); and</text></subparagraph><subparagraph id="H9ED6EB1A185A4A7E91A2E363B79CFC68" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">with respect to such a test furnished on or after January 1, 2031, equal to the lesser of—</text><clause id="HDC545333105F425A9BD3EC14C75234C9" commented="no"><enum>(i)</enum><text>the amount described in <internal-xref idref="HFAE299AA66714012B84880A524787050" legis-path="(aa)(1)(A)">subparagraph (A)</internal-xref>; or</text></clause><clause id="H6FAD9252BBDE44BF9B748A55BD850A90" commented="no"><enum>(ii)</enum><text>the payment amount determined for such test under section 1834A.</text></clause></subparagraph></paragraph><paragraph id="H3CFB181DEE5146DCAC673F2844ECEB81" commented="no"><enum>(2)</enum><header>Limitations</header><subparagraph id="H4493BD4B4B364AC1978075144899EA4E" commented="no"><enum>(A)</enum><header>In general</header><text>No payment may be made under this part for a multi-cancer early detection screening test furnished during a year to an individual if—</text><clause id="H2DC8D469C94E400E96A55099B0DB0B50" commented="no"><enum>(i)</enum><text>such individual—</text><subclause id="H916ECB4E8C354D5A8BE461ECA222B9A9"><enum>(I)</enum><text>is under 50 years of age; or</text></subclause><subclause id="HBE70D36E037645939B72F3A427BB9857"><enum>(II)</enum><text>as of January 1 of such year, has attained the age specified in <internal-xref idref="HAFAA259A5798417780542E6DD1EF2343" legis-path="(aa)(2)(B)">subparagraph (B)</internal-xref> for such year; or</text></subclause></clause><clause id="H463CB4BD04E746A5A556C89657CDEE03" commented="no"><enum>(ii)</enum><text display-inline="yes-display-inline">such a test was furnished to the individual during the previous 11 months.</text></clause></subparagraph><subparagraph id="HAFAA259A5798417780542E6DD1EF2343" commented="no"><enum>(B)</enum><header>Age specified</header><text>For purposes of <internal-xref idref="HBE70D36E037645939B72F3A427BB9857" legis-path="(aa)(2)(A)(i)(II)">subparagraph (A)(i)(II)</internal-xref>, the age specified in this subparagraph is—</text><clause id="HB9DE1ED898CC4E4CA4595B252AE4538C" commented="no"><enum>(i)</enum><text>for 2029, 65 years of age; and</text></clause><clause id="H9BCF738D840A4B6CA5B144C309DFE8E2" commented="no"><enum>(ii)</enum><text>for a succeeding year, the age specified in this subparagraph for the preceding year, increased by 1 year.</text></clause></subparagraph><subparagraph id="H145627A41B38456F97EE144C691EF0B8" commented="no"><enum>(C)</enum><header>Standards following USPSTF rating of A or B</header><text>In the case of a multi-cancer early detection screening test that is recommended with a grade of A or B by the United States Preventive Services Task Force, beginning on the date on which coverage for such test is provided pursuant to section 1861(ddd)(1), the preceding provisions of this paragraph shall not apply.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="H992FECE13BE54BC2827FDECD9DE2BEA8"><enum>(2)</enum><header>Conforming amendments</header><subparagraph id="HC79D4F99CA254C69884E421A6A66E39E"><enum>(A)</enum><text>Section 1833 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l</external-xref>) is amended—</text><clause id="H512D11FBDBC1465F9BFD19067D07F70C"><enum>(i)</enum><text>in subsection (a)—</text><subclause id="HC9093961DDAA45748478D7E8D9D2A08D"><enum>(I)</enum><text>in paragraph (1)(D)(i)(I), by striking <quote>section 1834(d)(1)</quote> and inserting <quote>subsection (d)(1) or (aa) of section 1834</quote>; and</text></subclause><subclause id="H52466B6211704F73AB9C6066E8380C2B"><enum>(II)</enum><text>in paragraph (2)(D)(i)(I), by striking <quote>section 1834(d)(1)</quote> and inserting <quote>subsection (d)(1) or (aa) of section 1834</quote>; and</text></subclause></clause><clause id="HEF44D03031974BF4B8EC54AD289B7EA9"><enum>(ii)</enum><text display-inline="yes-display-inline">in subsection (h)(1)(A), by striking <quote>section 1834(d)(1)</quote> and inserting <quote>subsections (d)(1) and (aa) of section 1834</quote>.</text></clause></subparagraph><subparagraph id="HE944BCF331B046F69DEDEC170D5E0728"><enum>(B)</enum><text>Section 1862(a)(1)(A) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395y">42 U.S.C. 1395y(a)(1)(A)</external-xref>) is amended—</text><clause id="H2E92F8F795A546819BC32B5F6A2EE2C1"><enum>(i)</enum><text>by striking <quote>or additional preventive services</quote> and inserting <quote>, additional preventive services</quote>; and</text></clause><clause id="H8B8C44A3D90F46BDA93ACFA293D45EC6"><enum>(ii)</enum><text>by inserting <quote>, or multi-cancer early detection screening tests (as defined in section 1861(nnn))</quote> after <quote>(as described in section 1861(ddd)(1))</quote>. </text></clause></subparagraph></paragraph></subsection><subsection id="H3BF28C43BC3D47E4BA0A0745C7B83E48"><enum>(c)</enum><header>Rule of construction relating to other cancer screening tests</header><text>Nothing in this section, including the amendments made by this section, shall be construed—</text><paragraph id="H96AEA0E60D904ADC88630D63739CCFDD"><enum>(1)</enum><text>in the case of an individual who undergoes a multi-cancer early detection screening test, to affect coverage under part B of title XVIII of the Social Security Act for other cancer screening tests covered under such title, such as screening tests for breast, cervical, colorectal, lung, or prostate cancer; or</text></paragraph><paragraph id="H385ED02DF8C1431082ACCE673BED0538"><enum>(2)</enum><text>in the case of an individual who undergoes another cancer screening test, to affect coverage under such part for a multi-cancer early detection screening test or the use of such a test as a diagnostic or confirmatory test for a result of the other cancer screening test.</text></paragraph></subsection></section><section id="HF1FE8B7075134426AF09EE965BFDB3EC" section-type="subsequent-section" display-inline="no-display-inline"><enum>225.</enum><header>Medicare coverage of external infusion pumps and non-self-administrable home infusion drugs</header><subsection id="H58938F2B0E6E47DB82F9E58A0A28B4A5"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1861(n) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(n)</external-xref>) is amended by adding at the end the following new sentence: </text><quoted-block style="OLC" id="HFEB20FBDC01840D68D0F2749EF82F12A" display-inline="yes-display-inline"><text>Beginning with the first calendar quarter beginning on or after the date that is 1 year after the date of the enactment of this sentence, an external infusion pump and associated home infusion drug (as defined in subsection (iii)(3)(C)) or other associated supplies that do not meet the appropriate for use in the home requirement applied to the definition of durable medical equipment under section 414.202 of title 42, Code of Federal Regulations (or any successor to such regulation) shall be treated as meeting such requirement if each of the following criteria is satisfied:</text><paragraph id="H4364B6A759A241B4B7E64484EE567802"><enum>(1)</enum><text>The prescribing information approved by the Food and Drug Administration for the home infusion drug associated with the pump instructs that the drug should be administered by or under the supervision of a health care professional.</text></paragraph><paragraph id="H48F4B7EC5B094E66AA3D5A9A4A017E0B"><enum>(2)</enum><text>A qualified home infusion therapy supplier (as defined in subsection (iii)(3)(D)) administers or supervises the administration of the drug or biological in a safe and effective manner in the patient’s home (as defined in subsection (iii)(3)(B)).</text></paragraph><paragraph id="HD3C717460B00469C9E595796907ADB77" commented="no"><enum>(3)</enum><text>The prescribing information described in paragraph (1) instructs that the drug should be infused at least 12 times per year—</text><subparagraph id="HF864BC3DF5B34E698DBFC528DEF6019C"><enum>(A)</enum><text>intravenously or subcutaneously; or</text></subparagraph><subparagraph id="H1CA8D0955D914756A11CB40598010210"><enum>(B)</enum><text>at infusion rates that the Secretary determines would require the use of an external infusion pump.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HB1AC832DA00D4A6396DA0BB8B2592AA1"><enum>(b)</enum><header>Cost sharing notification</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services shall ensure that patients are notified of the cost sharing for electing home infusion therapy compared to other applicable settings of care for the furnishing of infusion drugs under the Medicare program.</text></subsection></section><section id="HDA167F085BF445919024D77AD32D387B"><enum>226.</enum><header>Assuring pharmacy access and choice for Medicare beneficiaries</header><subsection commented="no" display-inline="no-display-inline" id="H1E507583CC1043CCA1268CD474406067"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text>Section 1860D–4(b)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-104">42 U.S.C. 1395w–104(b)(1)</external-xref>) is amended by striking subparagraph (A) and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H14C0FEC5E5324101A3119CA6990CE530"><subparagraph id="HAAE2D56B8708481B87EA9C86146B95E9"><enum>(A)</enum><header>In general</header><clause id="HE24E8426151D4059AFB9B1FCA55D3FE6"><enum>(i)</enum><header>Participation of any willing pharmacy</header><text>A PDP sponsor offering a prescription drug plan shall permit any pharmacy that meets the standard contract terms and conditions under such plan to participate as a network pharmacy of such plan.</text></clause><clause id="H6FC2ACA719FE49149774004782A330A9"><enum>(ii)</enum><header>Contract terms and conditions</header><subclause commented="no" display-inline="no-display-inline" id="H7E0C561E0B3644B588B668CED48728D8"><enum>(I)</enum><header display-inline="yes-display-inline">In general</header><text>Notwithstanding any other provision of law, for plan years beginning on or after January 1, 2028, in accordance with clause (i), contract terms and conditions offered by such PDP sponsor shall be reasonable and relevant according to standards established by the Secretary under subclause (II). </text></subclause><subclause commented="no" display-inline="no-display-inline" id="H6706A727C5E647BD926732BB9284B1F9"><enum>(II)</enum><header>Standards</header><text display-inline="yes-display-inline">Not later than the first Monday in April of 2027, the Secretary shall establish standards for reasonable and relevant contract terms and conditions for purposes of this clause.</text></subclause><subclause id="HED2E1CA5DB684B4B9A239FA2EDE6EC8F"><enum>(III)</enum><header>Request for information</header><text>Not later than April 1, 2026, for purposes of establishing the standards under subclause (II), the Secretary shall issue a request for information to seek input on trends in prescription drug plan and network pharmacy contract terms and conditions, current prescription drug plan and network pharmacy contracting practices, whether pharmacy reimbursement and dispensing fees paid by PDP sponsors to network pharmacies sufficiently cover the ingredient and operational costs of such pharmacies, the use and application of pharmacy quality measures by PDP sponsors for network pharmacies, PDP sponsor restrictions or limitations on the dispensing of covered part D drugs by network pharmacies (or any subsets of such pharmacies), PDP sponsor auditing practices for network pharmacies, areas in current regulations or program guidance related to contracting between prescription drug plans and network pharmacies requiring clarification or additional specificity, factors for consideration in determining the reasonableness and relevance of contract terms and conditions between prescription drug plans and network pharmacies, and other issues as determined appropriate by the Secretary.</text></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H943CEB56898B4FF18347741545C16AE4"><enum>(b)</enum><header>Essential retail pharmacies</header><text>Section 1860D–42 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-152">42 U.S.C. 1395w–152</external-xref>) is amended by adding at the end the following new subsection:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H33CF791477504D79B928EE4B5B3AF3F6"><subsection id="HA729BD0F15464559B7D07F62ED70FFE2"><enum>(e)</enum><header>Essential retail pharmacies</header><paragraph id="HDCF31E8E2E054B09B1D48BB8A5BB3D21"><enum>(1)</enum><header>In general</header><text>With respect to plan years beginning on or after January 1, 2028, the Secretary shall publish reports, at least once every 2 years until 2034, and periodically thereafter, that provide information, to the extent feasible, on—</text><subparagraph id="HF7B8444D5CC943D19F690E62DDB2A2EC"><enum>(A)</enum><text>trends in ingredient cost reimbursement, dispensing fees, incentive payments and other fees paid by PDP sponsors offering prescription drug plans and MA organizations offering MA–PD plans under this part to essential retail pharmacies (as defined in paragraph (2)) with respect to the dispensing of covered part D drugs, including a comparison of such trends between essential retail pharmacies and pharmacies that are not essential retail pharmacies;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7F6476AD78854334BDDA496E70608CCF"><enum>(B)</enum><text display-inline="yes-display-inline">trends in amounts paid to PDP sponsors offering prescription drug plans and MA organizations offering MA–PD plans under this part by essential retail pharmacies with respect to the dispensing of covered part D drugs, including a comparison of such trends between essential retail pharmacies and pharmacies that are not essential retail pharmacies;</text></subparagraph><subparagraph id="HFB80C3ACA19C4E309B5C04BB170596B3"><enum>(C)</enum><text>trends in essential retail pharmacy participation in pharmacy networks and preferred pharmacy networks for prescription drug plans offered by PDP sponsors and MA–PD plans offered by MA organizations under this part, including a comparison of such trends between essential retail pharmacies and pharmacies that are not essential retail pharmacies;</text></subparagraph><subparagraph id="H177EBB54DE92438D9A7DD23E88A65B84"><enum>(D)</enum><text>trends in the number of essential retail pharmacies, including variation in such trends by geographic region or other factors;</text></subparagraph><subparagraph id="HC5242CD93F36488CAB480FE5EE39C10D"><enum>(E)</enum><text>a comparison of cost-sharing for covered part D drugs dispensed by essential retail pharmacies that are network pharmacies for prescription drug plans offered by PDP sponsors and MA–PD plans offered by MA organizations under this part and cost-sharing for covered part D drugs dispensed by other network pharmacies for such plans located in similar geographic areas that are not essential retail pharmacies;</text></subparagraph><subparagraph id="H7B191934AA5F460CBCC18BAFDA335BED"><enum>(F)</enum><text>a comparison of the volume of covered part D drugs dispensed by essential retail pharmacies that are network pharmacies for prescription drug plans offered by PDP sponsors and MA–PD plans offered by MA organizations under this part and such volume of dispensing by network pharmacies for such plans located in similar geographic areas that are not essential retail pharmacies, including information on any patterns or trends in such comparison specific to certain types of covered part D drugs, such as generic drugs or drugs specified as specialty drugs by a PDP sponsor under a prescription drug plan or an MA organization under an MA–PD plan; and</text></subparagraph><subparagraph id="H41C3F2042C4E4ECA841BA3BFF0CE2AAC"><enum>(G)</enum><text>a comparison of the information described in subparagraphs (A) through (F) between essential retail pharmacies that are network pharmacies for prescription drug plans offered by PDP sponsors under this part and essential retail pharmacies that are network pharmacies for MA–PD plans offered by MA organizations under this part.</text></subparagraph></paragraph><paragraph id="HD1D5A958E932430B84FC43B560601212"><enum>(2)</enum><header>Definition of essential retail pharmacy</header><text>In this subsection, the term <term>essential retail pharmacy</term> means, with respect to a plan year, a retail pharmacy that—</text><subparagraph id="H01B4D5CAFEC945179F818C78FD708D55"><enum>(A)</enum><text>is not a pharmacy that is an affiliate as defined in paragraph (4); and</text></subparagraph><subparagraph id="H5BD601C187E941E5ABDB3D7C98B1D358"><enum>(B)</enum><text>is located in—</text><clause id="H38E0B35F8D8446E9989E412C1057DD80"><enum>(i)</enum><text>a medically underserved area (as designated pursuant to section 330(b)(3)(A) of the Public Health Service Act);</text></clause><clause id="H2E42AFF6574C44F6B0926E4FAAACB61A"><enum>(ii)</enum><text>a rural area in which there is no other retail pharmacy within 10 miles, as determined by the Secretary;</text></clause><clause id="H657E52FE37B44D4D87AC5787062680DF"><enum>(iii)</enum><text>a suburban area in which there is no other retail pharmacy within 2 miles, as determined by the Secretary; or</text></clause><clause id="H11D5DE8D617646F5BC160D9F34C12CDC"><enum>(iv)</enum><text>an urban area in which there is no other retail pharmacy within 1 mile, as determined by the Secretary. </text></clause></subparagraph></paragraph><paragraph id="HCC258D16430542FE88B804BB01C158E0"><enum>(3)</enum><header>List of essential retail pharmacies</header><subparagraph id="HF074CF045CAD40EC8D4C6B9B464AD2F9"><enum>(A)</enum><header>Publication of list of essential retail pharmacies</header><text>For each plan year (beginning with plan year 2028), the Secretary shall publish, on a publicly available internet website of the Centers for Medicare &amp; Medicaid Services, a list of pharmacies that meet the criteria described in subparagraphs (A) and (B) of paragraph (2) to be considered an essential retail pharmacy.</text></subparagraph><subparagraph id="H08C7C15705F244418EC5DE6FF011C613"><enum>(B)</enum><header>Required submissions from pdp sponsors</header><text>For each plan year (beginning with plan year 2028), each PDP sponsor offering a prescription drug plan and each MA organization offering an MA–PD plan shall submit to the Secretary, for the purposes of determining retail pharmacies that meet the criterion specified in subparagraph (A) of paragraph (2), a list of retail pharmacies that are affiliates of such sponsor or organization, or are affiliates of a pharmacy benefit manager acting on behalf of such sponsor or organization, at a time, and in a form and manner, specified by the Secretary.</text></subparagraph><subparagraph id="H35CD69FF6C804C6DAC4B2DDF96A242D5"><enum>(C)</enum><header>Reporting by pdp sponsors and ma organizations</header><text>For each plan year beginning with plan year 2027, each PDP sponsor offering a prescription drug plan and each MA organization offering an MA–PD plan under this part shall submit to the Secretary information on incentive payments and other fees paid by such sponsor or organization to pharmacies, insofar as any such payments or fees are not otherwise reported, at a time, and in a form and manner, specified by the Secretary. </text></subparagraph><subparagraph id="H0993A1B8210948AEA1D24D36FDC96087"><enum>(D)</enum><header>Implementation</header><text>Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise.</text></subparagraph><subparagraph id="H0D57A228F65F49A1B07EA145F862B829"><enum>(E)</enum><header>Nonapplication of paperwork reduction act</header><text><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/44/35">Chapter 35</external-xref> of title 44, United States Code, shall not apply to the implementation of this paragraph.</text></subparagraph></paragraph><paragraph id="H0D3FE8A498B641C383BB9D96ABB9E36E"><enum>(4)</enum><header>Definition of affiliate; pharmacy benefit manager</header><text>In this subsection, the terms <term>affiliate</term> and <term>pharmacy benefit manager</term> have the meaning given those terms in section 1860D–12(h)(7).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H9CC4B13CDE5E4B30A655E5F73BE8C86D"><enum>(c)</enum><header>Enforcement</header><paragraph id="HECAA8BCEAE8647A28B2C84664BD2028A"><enum>(1)</enum><header>In general</header><text>Section 1860D–4(b)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-104">42 U.S.C. 1395w–104(b)(1)</external-xref>) is amended by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H4A0D45A08F51429788EC6C753C9189D2"><subparagraph id="H632985D2B1BF4FB8800D354CFC234D8B"><enum>(F)</enum><header>Enforcement of standards for reasonable and relevant contract terms and conditions</header><clause id="HF55336E1F2F94E2F8D0AF1FAF02C7C22"><enum>(i)</enum><header>Allegation submission process</header><subclause id="H1BF0BEF218414293BEDC61AB60C7D9EB"><enum>(I)</enum><header>In general</header><text>Not later than January 1, 2028, the Secretary shall establish a process through which a pharmacy may submit to the Secretary an allegation of a violation by a PDP sponsor offering a prescription drug plan of the standards for reasonable and relevant contract terms and conditions under subparagraph (A)(ii), or of subclause (VIII) of this clause.</text></subclause><subclause id="H1FF2386C04F746238ADE7847F41903C9"><enum>(II)</enum><header>Frequency of submission</header><item id="H40FDF01A32B246F78174271773CB4EA2"><enum>(aa)</enum><header>In general</header><text>Except as provided in item (bb), the allegation submission process under this clause shall allow pharmacies to submit any allegations of violations described in subclause (I) not more frequently than once per plan year per contract between a pharmacy and a PDP sponsor.</text></item><item id="HD8971ABBB38C47ED882781197309D920"><enum>(bb)</enum><header>Allegations relating to contract modifications</header><text>In the case where a contract between a pharmacy and a PDP sponsor is modified following the submission of allegations by a pharmacy with respect to such contract and plan year, the allegation submission process under this clause shall allow such pharmacy to submit an additional allegation related to those modifications with respect to such contract and plan year.</text></item></subclause><subclause id="H4058FDA341C742168A47A5D3FEF2B768"><enum>(III)</enum><header>Access to relevant documents and materials</header><text>A PDP sponsor subject to an allegation under this clause—</text><item id="HC11A03BA76EE4DCE9B7E732F98EAC65E"><enum>(aa)</enum><text>shall provide documents or materials, as specified by the Secretary, including contract offers made by such sponsor to such pharmacy or correspondence related to such offers, to the Secretary at a time, and in a form and manner, specified by the Secretary; and</text></item><item id="HCB419380DE5A42A486EA3867FED4F02E"><enum>(bb)</enum><text>shall not prohibit or otherwise limit the ability of a pharmacy to submit such documents or materials to the Secretary for the purpose of submitting an allegation or providing evidence for such an allegation under this clause.</text></item></subclause><subclause id="H2B626C6DD821411F972A821658BFC27F"><enum>(IV)</enum><header>Standardized template</header><text>The Secretary shall establish a standardized template for pharmacies to use for the submission of allegations described in subclause (I). Such template shall require that the submission include a certification by the pharmacy that the information included is accurate, complete, and true to the best of the knowledge, information, and belief of such pharmacy.</text></subclause><subclause id="H001D69054C114C6AA1D754A5527F2CB3"><enum>(V)</enum><header>Preventing frivolous allegations</header><text>In the case where the Secretary determines that a pharmacy has submitted frivolous allegations under this clause on a routine basis, the Secretary may temporarily prohibit such pharmacy from using the allegation submission process under this clause, as determined appropriate by the Secretary.</text></subclause><subclause id="H8F0C9C3E06124C2797658D1108863CCE"><enum>(VI)</enum><header>Exemption from freedom of information act</header><text>Allegations submitted under this clause shall be exempt from disclosure under section 552 of title 5, United States Code.</text></subclause><subclause id="H053886B907C447D9842DA33947401F19"><enum>(VII)</enum><header>Rule of construction</header><text>Nothing in this clause shall be construed as limiting the ability of a pharmacy to pursue other legal actions or remedies, consistent with applicable Federal or State law, with respect to a potential violation of a requirement described in this subparagraph. </text></subclause><subclause id="HCCBDEA8EE51B4DD7BDDAA517B4020364"><enum>(VIII)</enum><header>Anti-retaliation and anti-coercion</header><text>Consistent with applicable Federal or State law, a PDP sponsor shall not—</text><item id="H04A92A38FF184D458B47E67B410EFC79"><enum>(aa)</enum><text>retaliate against a pharmacy for submitting any allegations under this clause; or</text></item><item id="H6D316574615E409EBF7BA3E5BCCD0123"><enum>(bb)</enum><text>coerce, intimidate, threaten, or interfere with the ability of a pharmacy to submit any such allegations. </text></item></subclause></clause><clause id="HA52E777746254B548AF7645AC78A3B1D"><enum>(ii)</enum><header>Investigation</header><text>The Secretary shall investigate, as determined appropriate by the Secretary, allegations submitted pursuant to clause (i).</text></clause><clause id="H1DC53BDC512B4C36A827E9B94A96CAD4"><enum>(iii)</enum><header>Enforcement</header><subclause id="HB1F43115F5CB46CFAC63FF6E3A6A8629"><enum>(I)</enum><header>In general</header><text>In the case where the Secretary determines that a PDP sponsor offering a prescription drug plan has violated the standards for reasonable and relevant contract terms and conditions under subparagraph (A)(ii), the Secretary may use authorities under sections 1857(g) and 1860D–12(b)(3)(E) to impose civil monetary penalties or other intermediate sanctions.</text></subclause><subclause id="H6D8EC6D092C34FA9A41AF295F333C377"><enum>(II)</enum><header>Application of civil monetary penalties</header><text>The provisions of section 1128A (other than subsections (a) and (b)) shall apply to a civil monetary penalty under this clause in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a).</text></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="H058FCA681AD244B798FAD38CE758047C"><enum>(2)</enum><header>Conforming amendment</header><text>Section 1857(g)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-27">42 U.S.C. 1395w–27(g)(1)</external-xref>) is amended—</text><subparagraph id="H23E7D98B262149138C12FA780055B1CD"><enum>(A)</enum><text>in subparagraph (J), by striking <quote>or</quote> after the semicolon;</text></subparagraph><subparagraph id="HA20D9ADB12874DA3ADE5537BDDD5DD04"><enum>(B)</enum><text>by redesignating subparagraph (K) as subparagraph (L);</text></subparagraph><subparagraph id="HC77955D6EE3B4E9C90CF644E9F3D4E41"><enum>(C)</enum><text>by inserting after subparagraph (J), the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H8B03E40F7E314E30BE44F7AA3A4DC637"><subparagraph id="H7401413C7A714249B7E18EF1F85DB6A1"><enum>(K)</enum><text>fails to comply with the standards for reasonable and relevant contract terms and conditions under subparagraph (A)(ii) of section 1860D–4(b)(1); or</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="H8ADBBF68C9884905833C84931029CA32"><enum>(D)</enum><text>in subparagraph (L), as redesignated by subparagraph (B), by striking <quote>through (J)</quote> and inserting <quote>through (K)</quote>; and</text></subparagraph><subparagraph id="HFE1618C5B04E42B6B40DAFAC11637621"><enum>(E)</enum><text>in the flush matter following subparagraph (L), as so redesignated, by striking <quote>subparagraphs (A) through (K)</quote> and inserting <quote>subparagraphs (A) through (L)</quote>.</text></subparagraph></paragraph></subsection><subsection id="HFE67CBDC965B4ED381A569A895D30743"><enum>(d)</enum><header>Accountability of pharmacy benefit managers for violations of reasonable and relevant contract terms and conditions</header><paragraph id="HA91F1C8765C94F0A92FD98D763445AA4"><enum>(1)</enum><header>In general</header><text>Section 1860D–12(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HB51DDB3A1D444569BA915D18DC31630F"><paragraph id="HB58166EA0FA6455D9215BC8D6314B0F2"><enum>(9)</enum><header>Accountability of pharmacy benefit managers for violations of reasonable and relevant contract terms and conditions</header><text>For plan years beginning on or after January 1, 2028, each contract entered into with a PDP sponsor under this part with respect to a prescription drug plan offered by such sponsor shall provide that any pharmacy benefit manager acting on behalf of such sponsor has a written agreement with the PDP sponsor under which the pharmacy benefit manager agrees to reimburse the PDP sponsor for any amounts paid by such sponsor under section 1860D–4(b)(1)(F)(iii)(I) to the Secretary as a result of a violation described in such section if such violation is related to a responsibility delegated to the pharmacy benefit manager by such PDP sponsor.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="H9BE1ACD34255449CB73ADB26E4AEC83B"><enum>(2)</enum><header>MA–PD plans</header><text>Section 1857(f)(3) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-27">42 U.S.C. 1395w–27(f)(3)</external-xref>) is amended by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HD5E9ECF7C89F42C1BC409A5188834BB7"><subparagraph id="H16132735E8264AA9B149DEB1BE3AC176"><enum>(F)</enum><header>Accountability of pharmacy benefit managers for violations of reasonable and relevant contract terms</header><text>For plan years beginning on or after January 1, 2028, section 1860D–12(b)(9).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HE333771332B248318AD0740CD85FC959"><enum>(e)</enum><header>Biennial report on enforcement and oversight of pharmacy access requirements</header><text>Section 1860D–42 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-152">42 U.S.C. 1395w–152</external-xref>), as amended by subsection (b), is amended by adding at the end the following new subsection:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H4AED8A1B1A8A456D9AAA7972F7C838D5"><subsection id="H078C21256CBE48A3B2AA331D81336D56"><enum>(f)</enum><header>Biennial report on enforcement and oversight of pharmacy access requirements</header><paragraph id="HE9564E4B02C4464C9632E2134B98E450"><enum>(1)</enum><header>In general</header><text>Not later than 2 years after the date of enactment of this subsection, and at least once every 2 years thereafter, the Secretary shall publish a report on enforcement and oversight actions and activities undertaken by the Secretary with respect to the requirements under section 1860D–4(b)(1).</text></paragraph><paragraph id="H5FC484D23B4442DCB3EE74E990CB05C4"><enum>(2)</enum><header>Limitation</header><text>A report under paragraph (1) shall not disclose—</text><subparagraph id="H590DA1E71ED647F884FCF19ECCD28CED"><enum>(A)</enum><text>identifiable information about individuals or entities unless such information is otherwise publicly available; or</text></subparagraph><subparagraph id="H00C2CD8C8DA1467D99C00288B5B67136"><enum>(B)</enum><text>trade secrets with respect to any entities.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H0C8B0787405B4F5091244E945F2E4958"><enum>(f)</enum><header>Funding</header><text>In addition to amounts otherwise available, there is appropriated to the Centers for Medicare &amp; Medicaid Services Program Management Account, out of any money in the Treasury not otherwise appropriated, $188,000,000 for fiscal year 2025, to remain available until expended, to carry out this section.</text></subsection></section><section id="H4077827B2077471081A309E97D27F6DF"><enum>227.</enum><header>Modernizing and Ensuring PBM Accountability</header><subsection id="H9917AC2A1C654209A6BBCD069B483EB2"><enum>(a)</enum><header>In general</header><paragraph id="HD0118FD879B3442B87BE73A4D71651D1"><enum>(1)</enum><header>Prescription drug plans</header><text>Section 1860D–12 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-112">42 U.S.C. 1395w–112</external-xref>) is amended by adding at the end the following new subsection:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H24C18998194C403A9BA7C1C6C3A3B7DA"><subsection id="H6EAF1575700941379E35999614B23274"><enum>(h)</enum><header>Requirements relating to pharmacy benefit managers</header><text>For plan years beginning on or after January 1, 2028:</text><paragraph id="H8437F73B3F7C4B0A93E5E6B41BCC7E0D"><enum>(1)</enum><header>Agreements with pharmacy benefit managers</header><text>Each contract entered into with a PDP sponsor under this part with respect to a prescription drug plan offered by such sponsor shall provide that any pharmacy benefit manager acting on behalf of such sponsor has a written agreement with the PDP sponsor under which the pharmacy benefit manager, and any affiliates of such pharmacy benefit manager, as applicable, agree to meet the following requirements:</text><subparagraph id="HA59F534386A34D5F97A8F72D9EA40E63"><enum>(A)</enum><header>No income other than bona fide service fees</header><clause id="HA3EE9D5F80984DBBB64D9FA7106D62F7"><enum>(i)</enum><header>In general</header><text>The pharmacy benefit manager and any affiliate of such pharmacy benefit manager shall not derive any remuneration with respect to any services provided on behalf of any entity or individual, in connection with the utilization of covered part D drugs, from any such entity or individual other than bona fide service fees, subject to clauses (ii) and (iii).</text></clause><clause id="H32EC7100DBB544E3B49586F0C4AD68F0"><enum>(ii)</enum><header>Incentive payments</header><text>For the purposes of this subsection, an incentive payment (as determined by the Secretary) paid by a PDP sponsor to a pharmacy benefit manager that is performing services on behalf of such sponsor shall be deemed a <quote>bona fide service fee</quote> (even if such payment does not otherwise meet the definition of such term under paragraph (7)(B)) if such payment is a flat dollar amount, is consistent with fair market value (as specified by the Secretary), is related to services actually performed by the pharmacy benefit manager or affiliate of such pharmacy benefit manager, on behalf of the PDP sponsor making such payment, in connection with the utilization of covered part D drugs, and meets additional requirements, if any, as determined appropriate by the Secretary.</text></clause><clause id="HCD6EA33C92554B84BB112548C540032E"><enum>(iii)</enum><header>Clarification on rebates and discounts used to lower costs for covered part d drugs</header><text>Rebates, discounts, and other price concessions received by a pharmacy benefit manager or an affiliate of a pharmacy benefit manager from manufacturers, even if such price concessions are calculated as a percentage of a drug’s price, shall not be considered a violation of the requirements of clause (i) if they are fully passed through to a PDP sponsor and are compliant with all regulatory and subregulatory requirements related to direct and indirect remuneration for manufacturer rebates under this part, including in cases where a PDP sponsor is acting as a pharmacy benefit manager on behalf of a prescription drug plan offered by such PDP sponsor.</text></clause><clause id="H9D35212FD5194FA78E579646866F9280"><enum>(iv)</enum><header>Evaluation of remuneration arrangements</header><text>Components of subsets of remuneration arrangements (such as fees or other forms of compensation paid to or retained by the pharmacy benefit manager or affiliate of such pharmacy benefit manager), as determined appropriate by the Secretary, between pharmacy benefit managers or affiliates of such pharmacy benefit managers, as applicable, and other entities involved in the dispensing or utilization of covered part D drugs (including PDP sponsors, manufacturers, pharmacies, and other entities as determined appropriate by the Secretary) shall be subject to review by the Secretary, in consultation with the Office of the Inspector General of the Department of Health and Human Services, as determined appropriate by the Secretary. The Secretary, in consultation with the Office of the Inspector General, shall review whether remuneration under such arrangements is consistent with fair market value (as specified by the Secretary) through reviews and assessments of such remuneration, as determined appropriate.</text></clause><clause id="H9E9761E717A0476198E530CE3D409F1F"><enum>(v)</enum><header>Disgorgement</header><text>The pharmacy benefit manager shall disgorge any remuneration paid to such pharmacy benefit manager or an affiliate of such pharmacy benefit manager in violation of this subparagraph to the PDP sponsor.</text></clause><clause commented="no" display-inline="no-display-inline" id="HC7F3EA9AFA8446EFAE86F898F69B4C15"><enum>(vi)</enum><header>Additional requirements</header><text>The pharmacy benefit manager shall—</text><subclause commented="no" display-inline="no-display-inline" id="H489D3A28FA13451B91EAD3DC5C6F193A"><enum>(I)</enum><text display-inline="yes-display-inline">enter into a written agreement with any affiliate of such pharmacy benefit manager, under which the affiliate shall identify and disgorge any remuneration described in clause (v) to the pharmacy benefit manager; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H93B72BD2277847FA818B5ACADC2FA812"><enum>(II)</enum><text display-inline="yes-display-inline">attest, subject to any requirements determined appropriate by the Secretary, that the pharmacy benefit manager has entered into a written agreement described in subclause (I) with any relevant affiliate of the pharmacy benefit manager.</text></subclause></clause></subparagraph><subparagraph id="H93504220460A449CBAB8ADFCE818EB6B"><enum>(B)</enum><header>Transparency regarding guarantees and cost performance evaluations</header><text>The pharmacy benefit manager shall—</text><clause id="HE1DA1721309746F592632ED25D4EC857"><enum>(i)</enum><text>define, interpret, and apply, in a fully transparent and consistent manner for purposes of calculating or otherwise evaluating pharmacy benefit manager performance against pricing guarantees or similar cost performance measurements related to rebates, discounts, price concessions, or net costs, terms such as—</text><subclause id="H0B3D50184A0C48B0B74CF279518425A6"><enum>(I)</enum><text><term>generic drug</term>, in a manner consistent with the definition of the term under section 423.4 of title 42, Code of Federal Regulations, or a successor regulation;</text></subclause><subclause id="H3384249AB63449FABE41510A04E76660"><enum>(II)</enum><text><term>brand name drug</term>, in a manner consistent with the definition of the term under section 423.4 of title 42, Code of Federal Regulations, or a successor regulation;</text></subclause><subclause id="HCB619EDDE2324C8489C412BA84AD9E6A"><enum>(III)</enum><text><term>specialty drug</term>;</text></subclause><subclause id="HFA41B0EC5E5D4CDE8C126757E97AE9F4"><enum>(IV)</enum><text><term>rebate</term>; and</text></subclause><subclause id="HB02C888C725A4FA2BA7059D75A475B84"><enum>(V)</enum><text><term>discount</term>;</text></subclause></clause><clause id="H8527D2C80EF7437CB0DA85BB6BE0821F"><enum>(ii)</enum><text>identify any drugs, claims, or price concessions excluded from any pricing guarantee or other cost performance measure in a clear and consistent manner; and</text></clause><clause id="HE5B69C2022D443F9AF2B7C3AD5ADF178"><enum>(iii)</enum><text>where a pricing guarantee or other cost performance measure is based on a pricing benchmark other than the wholesale acquisition cost (as defined in section 1847A(c)(6)(B)) of a drug, calculate and provide a wholesale acquisition cost-based equivalent to the pricing guarantee or other cost performance measure.</text></clause></subparagraph><subparagraph id="HDD6FAF5E33F84482BA49F272E3B3682B"><enum>(C)</enum><header>Provision of information</header><clause id="H9C5D87D9B8CF46559B1CFD0BF157A782"><enum>(i)</enum><header>In general</header><text>Not later than July 1 of each year, beginning in 2028, the pharmacy benefit manager shall submit to the PDP sponsor, and to the Secretary, a report, in accordance with this subparagraph, and shall make such report available to such sponsor at no cost to such sponsor in a format specified by the Secretary under paragraph (5). Each such report shall include, with respect to such PDP sponsor and each plan offered by such sponsor, the following information with respect to the previous plan year:</text><subclause id="H8EA8FE9AB71F4120A9DB86DACEC6DDFD"><enum>(I)</enum><text>A list of all drugs covered by the plan that were dispensed including, with respect to each such drug—</text><item id="HA9A685FDF1EA460E91DBF52C59CE35C4"><enum>(aa)</enum><text>the brand name, generic or non-proprietary name, and National Drug Code;</text></item><item id="H676E6A67C9514A969860B6855946F24D"><enum>(bb)</enum><text>the number of plan enrollees for whom the drug was dispensed, the total number of prescription claims for the drug (including original prescriptions and refills, counted as separate claims), and the total number of dosage units of the drug dispensed;</text></item><item id="H33C02B2074A049E7B4E5764E9A92016B"><enum>(cc)</enum><text>the number of prescription claims described in item (bb) by each type of dispensing channel through which the drug was dispensed, including retail, mail order, specialty pharmacy, long term care pharmacy, home infusion pharmacy, or other types of pharmacies or providers;</text></item><item id="HC6AC1E6467E348689D29085FC3CB262D"><enum>(dd)</enum><text>the average wholesale acquisition cost, listed as cost per day’s supply, cost per dosage unit, and cost per typical course of treatment (as applicable);</text></item><item id="HA4C8ECC185BF4824929697AA84495B37"><enum>(ee)</enum><text>the average wholesale price for the drug, listed as price per day’s supply, price per dosage unit, and price per typical course of treatment (as applicable);</text></item><item id="H22A031874095428EAA9F93AE6C385188"><enum>(ff)</enum><text>the total out-of-pocket spending by plan enrollees on such drug after application of any benefits under the plan, including plan enrollee spending through copayments, coinsurance, and deductibles;</text></item><item id="HE069FB5FCE8A4F90B209F3C8E9529841"><enum>(gg)</enum><text>total rebates paid by the manufacturer on the drug as reported under the Detailed DIR Report (or any successor report) submitted by such sponsor to the Centers for Medicare &amp; Medicaid Services;</text></item><item id="H4C796E8F6601470A985DA19A6C836ED9"><enum>(hh)</enum><text>all other direct or indirect remuneration on the drug as reported under the Detailed DIR Report (or any successor report) submitted by such sponsor to the Centers for Medicare &amp; Medicaid Services;</text></item><item id="H516EB04195D84E5494EB70870327E573"><enum>(ii)</enum><text>the average pharmacy reimbursement amount paid by the plan for the drug in the aggregate and disaggregated by dispensing channel identified in item (cc);</text></item><item id="HCE653D81ECEA4D668BDC6C3697B446BB"><enum>(jj)</enum><text>the average National Average Drug Acquisition Cost (NADAC); and</text></item><item id="HF5D1E9B14E304FB988617D1544191E7D"><enum>(kk)</enum><text>total manufacturer-derived revenue, inclusive of bona fide service fees, attributable to the drug and retained by the pharmacy benefit manager and any affiliate of such pharmacy benefit manager.</text></item></subclause><subclause id="HA61EA7A6B7FE4C1D89E11D06595D9479"><enum>(II)</enum><text>In the case of a pharmacy benefit manager that has an affiliate that is a retail, mail order, or specialty pharmacy, with respect to drugs covered by such plan that were dispensed, the following information:</text><item id="HB6704B1ED6A14100917228292B0C8634"><enum>(aa)</enum><text>The percentage of total prescriptions that were dispensed by pharmacies that are an affiliate of the pharmacy benefit manager for each drug.</text></item><item id="H3EC5C8FC3EE24565A10FA83E6034C044"><enum>(bb)</enum><text>The interquartile range of the total combined costs paid by the plan and plan enrollees, per dosage unit, per course of treatment, per 30-day supply, and per 90-day supply for each drug dispensed by pharmacies that are not an affiliate of the pharmacy benefit manager and that are included in the pharmacy network of such plan.</text></item><item id="H1C48D54850AB4BA6BC9992C53FD26463"><enum>(cc)</enum><text>The interquartile range of the total combined costs paid by the plan and plan enrollees, per dosage unit, per course of treatment, per 30-day supply, and per 90-day supply for each drug dispensed by pharmacies that are an affiliate of the pharmacy benefit manager and that are included in the pharmacy network of such plan.</text></item><item id="H280E33E3C63A486CB357F7842ADF290A"><enum>(dd)</enum><text>The lowest total combined cost paid by the plan and plan enrollees, per dosage unit, per course of treatment, per 30-day supply, and per 90-day supply, for each drug that is available from any pharmacy included in the pharmacy network of such plan.</text></item><item id="H37628C4E6B5A417BAD3EE90F2404B44E"><enum>(ee)</enum><text>The difference between the average acquisition cost of the affiliate, such as a pharmacy or other entity that acquires prescription drugs, that initially acquires the drug and the amount reported under subclause (I)(jj) for each drug.</text></item><item id="HE1FE2F2142B64155B863EBDF1F691FA9"><enum>(ff)</enum><text>A list inclusive of the brand name, generic or non-proprietary name, and National Drug Code of covered part D drugs subject to an agreement with a covered entity under section 340B of the Public Health Service Act for which the pharmacy benefit manager or an affiliate of the pharmacy benefit manager had a contract or other arrangement with such a covered entity in the service area of such plan.</text></item></subclause><subclause id="H5F1B6961B7D44520B51DA480C3C433F3"><enum>(III)</enum><text>Where a drug approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act (referred to in this subclause as the <quote>listed drug</quote>) is covered by the plan, the following information:</text><item id="H35C0800C8107429F8624624E462AA358"><enum>(aa)</enum><text>A list of currently marketed generic drugs approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act pursuant to an application that references such listed drug that are not covered by the plan, are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the listed drug, or are subject to utilization management that the listed drug is not subject to.</text></item><item id="H8284181314664BF3A239863935B03BDC"><enum>(bb)</enum><text>The estimated average beneficiary cost-sharing under the plan for a 30-day supply of the listed drug.</text></item><item id="HA4EFCFEE9F784F218E1A9D642D93C7FC"><enum>(cc)</enum><text>Where a generic drug listed under item (aa) is on a formulary tier typically associated with higher cost-sharing than the listed drug, the estimated average cost-sharing that a beneficiary would have paid for a 30-day supply of each of the generic drugs described in item (aa), had the plan provided coverage for such drugs on the same formulary tier as the listed drug.</text></item><item id="HC865D6900A5440F081152211F68CBF9C"><enum>(dd)</enum><text>A written justification for providing more favorable coverage of the listed drug than the generic drugs described in item (aa).</text></item><item id="H05A34DDBC5F14291BCFFF17775BA86B1"><enum>(ee)</enum><text>The number of currently marketed generic drugs approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act pursuant to an application that references such listed drug.</text></item></subclause><subclause id="H8D57B55CCED5425BB9CA615E84123ECA"><enum>(IV)</enum><text>Where a reference product (as defined in section 351(i) of the Public Health Service Act) is covered by the plan, the following information:</text><item id="H13EAC330E4874859975A4C824BA75AC2"><enum>(aa)</enum><text>A list of currently marketed biosimilar biological products licensed under section 351(k) of the Public Health Service Act pursuant to an application that refers to such reference product that are not covered by the plan, are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the reference product, or are subject to utilization management that the reference product is not subject to.</text></item><item id="HC5A7EAD3D45E4272AC90D08D1E073A6A"><enum>(bb)</enum><text>The estimated average beneficiary cost-sharing under the plan for a 30-day supply of the reference product.</text></item><item id="HF2C414ABA14841E19E9B0FA8F834C070"><enum>(cc)</enum><text>Where a biosimilar biological product listed under item (aa) is on a formulary tier typically associated with higher cost-sharing than the reference product, the estimated average cost-sharing that a beneficiary would have paid for a 30-day supply of each of the biosimilar biological products described in item (aa), had the plan provided coverage for such products on the same formulary tier as the reference product.</text></item><item id="H85AFDF3320C444ABA56991E9786D371F"><enum>(dd)</enum><text>A written justification for providing more favorable coverage of the reference product than the biosimilar biological product described in item (aa).</text></item><item id="H6C56AAE5CB5742BCAE065DE8EF261D72"><enum>(ee)</enum><text>The number of currently marketed biosimilar biological products licensed under section 351(k) of the Public Health Service Act, pursuant to an application that refers to such reference product.</text></item></subclause><subclause id="HB04CF55F51DC47148E390894C5D865A2"><enum>(V)</enum><text>Total gross spending on covered part D drugs by the plan, not net of rebates, fees, discounts, or other direct or indirect remuneration.</text></subclause><subclause id="H55FFCD4BF8EE433FB31364CAA762FFD1"><enum>(VI)</enum><text>The total amount retained by the pharmacy benefit manager or an affiliate of such pharmacy benefit manager in revenue related to utilization of covered part D drugs under that plan, inclusive of bona fide service fees.</text></subclause><subclause id="HB5440F0748344909BE10B79317235C97"><enum>(VII)</enum><text>The total spending on covered part D drugs net of rebates, fees, discounts, or other direct and indirect remuneration by the plan.</text></subclause><subclause id="H0A21F3BD40EE4B5094E7292E606D6CAA"><enum>(VIII)</enum><text>An explanation of any benefit design parameters under such plan that encourage plan enrollees to fill prescriptions at pharmacies that are an affiliate of such pharmacy benefit manager, such as mail and specialty home delivery programs, and retail and mail auto-refill programs.</text></subclause><subclause id="HD96769DD58B94454913449A66CBC0D7B"><enum>(IX)</enum><text>The following information:</text><item commented="no" display-inline="no-display-inline" id="HFEAF679153D145C0B4B617E7D271A90A"><enum>(aa)</enum><text display-inline="yes-display-inline">A list of all brokers, consultants, advisors, and auditors that receive compensation from the pharmacy benefit manager or an affiliate of such pharmacy benefit manager for referrals, consulting, auditing, or other services offered to PDP sponsors related to pharmacy benefit management services.</text></item><item commented="no" display-inline="no-display-inline" id="H7533C38323114572A5FFA238D163205C"><enum>(bb)</enum><text>The amount of compensation provided by such pharmacy benefit manager or affiliate to each such broker, consultant, advisor, and auditor.</text></item><item commented="no" display-inline="no-display-inline" id="HE2F9C35CA2534900A0740A4CCBABD2A9"><enum>(cc)</enum><text display-inline="yes-display-inline">The methodology for calculating the amount of compensation provided by such pharmacy benefit manager or affiliate, for each such broker, consultant, advisor, and auditor.</text></item></subclause><subclause id="H4DA23101405843E8880ED64B3E9F694A"><enum>(X)</enum><text>A list of all affiliates of the pharmacy benefit manager.</text></subclause><subclause id="HFDC90FD927BE4BD9ACF9CB81CEAEDD07"><enum>(XI)</enum><text>A summary document submitted in a standardized template developed by the Secretary that includes such information described in subclauses (I) through (X).</text></subclause></clause><clause id="HAD4D03164A6544B8B9872E58FD3A0C21"><enum>(ii)</enum><header>Written explanation of contracts or agreements with drug manufacturers</header><subclause id="H0A9756A79A63421DBD46528E29551318"><enum>(I)</enum><header>In general</header><text>The pharmacy benefit manager shall, not later than 30 days after the finalization of any contract or agreement between such pharmacy benefit manager or an affiliate of such pharmacy benefit manager and a drug manufacturer (or subsidiary, agent, or entity affiliated with such drug manufacturer) that makes rebates, discounts, payments, or other financial incentives related to one or more covered part D drugs or other prescription drugs, as applicable, of the manufacturer directly or indirectly contingent upon coverage, formulary placement, or utilization management conditions on any other covered part D drugs or other prescription drugs, as applicable, submit to the PDP sponsor a written explanation of such contract or agreement.</text></subclause><subclause id="H52C4B8196EF54F63829D7E20FF887FC0"><enum>(II)</enum><header>Requirements</header><text>A written explanation under subclause (I) shall—</text><item id="H65058C77FDCA4E2AB966337BA29CD1D2"><enum>(aa)</enum><text>include the manufacturer subject to the contract or agreement, all covered part D drugs and other prescription drugs, as applicable, subject to the contract or agreement and the manufacturers of such drugs, and a high-level description of the terms of such contract or agreement and how such terms apply to such drugs; and</text></item><item id="H197EC760D15F45378EAC6D88B8F7979A"><enum>(bb)</enum><text>be certified by the Chief Executive Officer, Chief Financial Officer, or General Counsel of such pharmacy benefit manager, or affiliate of such pharmacy benefit manager, as applicable, or an individual delegated with the authority to sign on behalf of one of these officers, who reports directly to the officer.</text></item></subclause><subclause id="H55E3134C166C4DEE8691AB0862ABB6CC"><enum>(III)</enum><header>Definition of other prescription drugs</header><text>For purposes of this clause, the term <term>other prescription drugs</term> means prescription drugs covered as supplemental benefits under this part or prescription drugs paid outside of this part. </text></subclause></clause></subparagraph><subparagraph id="HF2E3C8AAD151453A8E8FB35195183443"><enum>(D)</enum><header>Audit rights</header><clause id="H62EE2B1905074B94ABD5809D1FFC70EF"><enum>(i)</enum><header>In general</header><text>Not less than once a year, at the request of the PDP sponsor, the pharmacy benefit manager shall allow for an audit of the pharmacy benefit manager to ensure compliance with all terms and conditions under the written agreement described in this paragraph and the accuracy of information reported under subparagraph (C).</text></clause><clause id="H195D3CD49C4741958F3E67E243A94895"><enum>(ii)</enum><header>Auditor</header><text>The PDP sponsor shall have the right to select an auditor. The pharmacy benefit manager shall not impose any limitations on the selection of such auditor.</text></clause><clause id="H31395D6EA73F42E8A46B583DDFAD1C88"><enum>(iii)</enum><header>Provision of information</header><text>The pharmacy benefit manager shall make available to such auditor all records, data, contracts, and other information necessary to confirm the accuracy of information provided under subparagraph (C), subject to reasonable restrictions on how such information must be reported to prevent redisclosure of such information.</text></clause><clause id="HC33CC6EABCF14C41A028D346CD26D401"><enum>(iv)</enum><header>Timing</header><text>The pharmacy benefit manager must provide information under clause (iii) and other information, data, and records relevant to the audit to such auditor within 6 months of the initiation of the audit and respond to requests for additional information from such auditor within 30 days after the request for additional information.</text></clause><clause id="HADEE821A5C6B465C8F70F4091632A033"><enum>(v)</enum><header>Information from affiliates</header><text>The pharmacy benefit manager shall be responsible for providing to such auditor information required to be reported under subparagraph (C) or under clause (iii) of this subparagraph that is owned or held by an affiliate of such pharmacy benefit manager.</text></clause></subparagraph></paragraph><paragraph id="HE20D5BD30DFB4181B127420FCB159C21"><enum>(2)</enum><header>Enforcement</header><subparagraph commented="no" display-inline="no-display-inline" id="HED67B86F919F44EB94F7A1801B517B2E"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Each PDP sponsor shall—</text><clause id="H542A6B577F634F9DBC1DA47794A476C2"><enum>(i)</enum><text>disgorge to the Secretary any amounts disgorged to the PDP sponsor by a pharmacy benefit manager under paragraph (1)(A)(v);</text></clause><clause commented="no" display-inline="no-display-inline" id="H06A1B9F573E940A5A43B01B30A1551AC"><enum>(ii)</enum><text display-inline="yes-display-inline">require, in a written agreement with any pharmacy benefit manager acting on behalf of such sponsor or affiliate of such pharmacy benefit manager, that such pharmacy benefit manager or affiliate reimburse the PDP sponsor for any civil money penalty imposed on the PDP sponsor as a result of the failure of the pharmacy benefit manager or affiliate to meet the requirements of paragraph (1) that are applicable to the pharmacy benefit manager or affiliate under the agreement; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H7E17301551F7451197DD494845346D46"><enum>(iii)</enum><text>require, in a written agreement with any such pharmacy benefit manager acting on behalf of such sponsor or affiliate of such pharmacy benefit manager, that such pharmacy benefit manager or affiliate be subject to punitive remedies for breach of contract for failure to comply with the requirements applicable under paragraph (1).</text></clause></subparagraph><subparagraph id="H60A37938145B4B759094B896FF4AB41B"><enum>(B)</enum><header>Reporting of alleged violations</header><text>The Secretary shall make available and maintain a mechanism for manufacturers, PDP sponsors, pharmacies, and other entities that have contractual relationships with pharmacy benefit managers or affiliates of such pharmacy benefit managers to report, on a confidential basis, alleged violations of paragraph (1)(A) or subparagraph (C).</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC00FEA071C994711B1C154885A7FE9DA"><enum>(C)</enum><header>Anti-retaliation and anti-coercion</header><text>Consistent with applicable Federal or State law, a PDP sponsor shall not—</text><clause commented="no" display-inline="no-display-inline" id="HB8A195DBD06A453EAE46E8D3025768F4"><enum>(i)</enum><text display-inline="yes-display-inline">retaliate against an individual or entity for reporting an alleged violation under subparagraph (B); or</text></clause><clause commented="no" display-inline="no-display-inline" id="H220A611A3F6E48529645A675BB5B1186"><enum>(ii)</enum><text display-inline="yes-display-inline">coerce, intimidate, threaten, or interfere with the ability of an individual or entity to report any such alleged violations.</text></clause></subparagraph></paragraph><paragraph id="HC8ABB6D4D83442348ACF647A1B9BCC46"><enum>(3)</enum><header>Certification of compliance</header><subparagraph commented="no" display-inline="no-display-inline" id="HB8352052A5DF4F108C37B779806F080E"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text>Each PDP sponsor shall furnish to the Secretary (at a time and in a manner specified by the Secretary) an annual certification of compliance with this subsection, as well as such information as the Secretary determines necessary to carry out this subsection.</text></subparagraph><subparagraph id="HC56D7D40327641EB8EFD33D116403D55"><enum>(B)</enum><header>Implementation</header><text>Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise.</text></subparagraph></paragraph><paragraph id="H2AAB154910924E739F7F7613066A205F"><enum>(4)</enum><header>Rule of construction</header><text>Nothing in this subsection shall be construed as—</text><subparagraph id="H91E95F41CC6F4D089E3D6E24FE991BA4"><enum>(A)</enum><text>prohibiting flat dispensing fees or reimbursement or payment for ingredient costs (including customary, industry-standard discounts directly related to drug acquisition that are retained by pharmacies or wholesalers) to entities that acquire or dispense prescription drugs; or</text></subparagraph><subparagraph id="HF0A0C6D07772450A86DD5820ABAB4256"><enum>(B)</enum><text>modifying regulatory requirements or sub-regulatory program instruction or guidance related to pharmacy payment, reimbursement, or dispensing fees.</text></subparagraph></paragraph><paragraph id="H02C1E5DB83AA4ACEB11EF9C612B15C0A"><enum>(5)</enum><header>Standard formats</header><subparagraph commented="no" display-inline="no-display-inline" id="H4A299D51E21B4FF8BC6497A6A7A2AE01"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text>Not later than June 1, 2027, the Secretary shall specify standard, machine-readable formats for pharmacy benefit managers to submit annual reports required under paragraph (1)(C)(i).</text></subparagraph><subparagraph id="H301252A30C3048A780E63F6B83037591"><enum>(B)</enum><header>Implementation</header><text>Notwithstanding any other provision of law, the Secretary may implement this paragraph by program instruction or otherwise.</text></subparagraph></paragraph><paragraph id="HEE55432477D14483AF7D505EE014B8D2"><enum>(6)</enum><header>Confidentiality</header><subparagraph id="H68C3D0C40C2E4788AA5A51D6D9634590"><enum>(A)</enum><header>In general</header><text>Information disclosed by a pharmacy benefit manager, an affiliate of a pharmacy benefit manager, a PDP sponsor, or a pharmacy under this subsection that is not otherwise publicly available or available for purchase shall not be disclosed by the Secretary or a PDP sponsor receiving the information, except that the Secretary may disclose the information for the following purposes:</text><clause id="H11AD7823D7B44505923CE4DF4F223846"><enum>(i)</enum><text>As the Secretary determines necessary to carry out this part.</text></clause><clause id="H6343BB9993CA459E82BF62D02A6FDA0C"><enum>(ii)</enum><text>To permit the Comptroller General to review the information provided.</text></clause><clause id="H2E7C17FE290B458AB0120986936622C1"><enum>(iii)</enum><text>To permit the Director of the Congressional Budget Office to review the information provided.</text></clause><clause id="HBA606ED303CF44DC8185F369827935F6"><enum>(iv)</enum><text>To permit the Executive Director of the Medicare Payment Advisory Commission to review the information provided.</text></clause><clause id="H0413C91BC7B74C76B55C31CEA8805A77"><enum>(v)</enum><text>To the Attorney General for the purposes of conducting oversight and enforcement under this title.</text></clause><clause id="HA5C17BE5A8CB422B810973FCC1A9BDB3"><enum>(vi)</enum><text>To the Inspector General of the Department of Health and Human Services in accordance with its authorities under the Inspector General Act of 1978 (section 406 of title 5, United States Code), and other applicable statutes.</text></clause></subparagraph><subparagraph id="HC79A97D7D42D46428CD68D600006C14B" commented="no"><enum>(B)</enum><header>Restriction on use of information</header><text>The Secretary, the Comptroller General, the Director of the Congressional Budget Office, and the Executive Director of the Medicare Payment Advisory Commission shall not report on or disclose information disclosed pursuant to subparagraph (A) to the public in a manner that would identify—</text><clause commented="no" display-inline="no-display-inline" id="HE34798FDDAE84B349CE2501A0F16B855"><enum>(i)</enum><text display-inline="yes-display-inline">a specific pharmacy benefit manager, affiliate, pharmacy, manufacturer, wholesaler, PDP sponsor, or plan; or</text></clause><clause commented="no" display-inline="no-display-inline" id="H26DA96CE61484074869C2AF1D71EAAD9"><enum>(ii)</enum><text display-inline="yes-display-inline">contract prices, rebates, discounts, or other remuneration for specific drugs in a manner that may allow the identification of specific contracting parties or of such specific drugs.</text></clause></subparagraph></paragraph><paragraph id="HF3A83C1CC897438295E1A3A60016B1B9"><enum>(7)</enum><header>Definitions</header><text>For purposes of this subsection:</text><subparagraph id="HC1CA428112334C4D8BD861F518AD71D0"><enum>(A)</enum><header>Affiliate</header><text>The term <term>affiliate</term> means, with respect to any pharmacy benefit manager or PDP sponsor, any entity that, directly or indirectly—</text><clause commented="no" display-inline="no-display-inline" id="H1608F537ECB240529796D6CA4342D1D7"><enum>(i)</enum><text display-inline="yes-display-inline">owns or is owned by, controls or is controlled by, or is otherwise related in any ownership structure to such pharmacy benefit manager or PDP sponsor; or</text></clause><clause commented="no" display-inline="no-display-inline" id="HED4D5685DB0B46159D4A5033699C3F21"><enum>(ii)</enum><text display-inline="yes-display-inline">acts as a contractor, principal, or agent to such pharmacy benefit manager or PDP sponsor, insofar as such contractor, principal, or agent performs any of the functions described under subparagraph (C).</text></clause></subparagraph><subparagraph id="HBC61E252A454464995AB435B707BF634"><enum>(B)</enum><header>Bona fide service fee</header><text>The term <term>bona fide service fee</term> means a fee that is reflective of the fair market value (as specified by the Secretary, through notice and comment rulemaking) for a bona fide, itemized service actually performed on behalf of an entity, that the entity would otherwise perform (or contract for) in the absence of the service arrangement and that is not passed on in whole or in part to a client or customer, whether or not the entity takes title to the drug. Such fee must be a flat dollar amount and shall not be directly or indirectly based on, or contingent upon—</text><clause id="HBBEC424105B34B3DAFB6F47448E77C24"><enum>(i)</enum><text>drug price, such as wholesale acquisition cost or drug benchmark price (such as average wholesale price);</text></clause><clause id="H1927F13070FB4B5AB0841CD146A6340C"><enum>(ii)</enum><text>the amount of discounts, rebates, fees, or other direct or indirect remuneration with respect to covered part D drugs dispensed to enrollees in a prescription drug plan, except as permitted pursuant to paragraph (1)(A)(ii);</text></clause><clause id="H4A3F38064A03458FABCBD5803948D270"><enum>(iii)</enum><text>coverage or formulary placement decisions or the volume or value of any referrals or business generated between the parties to the arrangement; or</text></clause><clause id="HA344FE3F6FD64479975D87370E0146E0"><enum>(iv)</enum><text>any other amounts or methodologies prohibited by the Secretary.</text></clause></subparagraph><subparagraph id="HA07DD0D9E4E743CC9B681A3F8B23CDE9"><enum>(C)</enum><header>Pharmacy benefit manager</header><text>The term <term>pharmacy benefit manager</term> means any person or entity that, either directly or through an intermediary, acts as a price negotiator or group purchaser on behalf of a PDP sponsor or prescription drug plan, or manages the prescription drug benefits provided by such sponsor or plan, including the processing and payment of claims for prescription drugs, the performance of drug utilization review, the processing of drug prior authorization requests, the adjudication of appeals or grievances related to the prescription drug benefit, contracting with network pharmacies, controlling the cost of covered part D drugs, or the provision of related services. Such term includes any person or entity that carries out one or more of the activities described in the preceding sentence, irrespective of whether such person or entity calls itself a <quote>pharmacy benefit manager</quote>.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="H6A84C927B14C49938E86960AB082A433"><enum>(2)</enum><header>MA–PD plans</header><text>Section 1857(f)(3) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-27">42 U.S.C. 1395w–27(f)(3)</external-xref>) is amended by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HDBD27B8CAB9647B6928E0FFF68D3049D"><subparagraph id="H2EE42638A81543ED989053D40A7149B1"><enum>(F)</enum><header>Requirements relating to pharmacy benefit managers</header><text>For plan years beginning on or after January 1, 2028, section 1860D–12(h).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="H6B7F44D0374E4496987E16D35303CB75"><enum>(3)</enum><header>Nonapplication of Paperwork Reduction Act</header><text><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/44/35">Chapter 35</external-xref> of title 44, United States Code, shall not apply to the implementation of this subsection.</text></paragraph><paragraph id="H0EA4D4818AE0406E8B0C1CA4276425C0"><enum>(4)</enum><header>Funding</header><subparagraph id="HF96A2ADA2A6A41B581708A20622E1DCF"><enum>(A)</enum><header>Secretary</header><text>In addition to amounts otherwise available, there is appropriated to the Centers for Medicare &amp; Medicaid Services Program Management Account, out of any money in the Treasury not otherwise appropriated, $113,000,000 for fiscal year 2025, to remain available until expended, to carry out this subsection.</text></subparagraph><subparagraph id="HB6C3DC40866D42BFA70A2A8731131C28"><enum>(B)</enum><header>OIG</header><text>In addition to amounts otherwise available, there is appropriated to the Inspector General of the Department of Health and Human Services, out of any money in the Treasury not otherwise appropriated, $20,000,000 for fiscal year 2025, to remain available until expended, to carry out this subsection. </text></subparagraph></paragraph></subsection><subsection id="HE822948701984E0BBD302F707EEA3E60"><enum>(b)</enum><header>GAO Study and Report on Price-Related Compensation Across the Supply Chain</header><paragraph id="H67A476E03FEA4B9EA270049FCC234DC1"><enum>(1)</enum><header>Study</header><text>The Comptroller General of the United States (in this subsection referred to as the <quote>Comptroller General</quote>) shall conduct a study describing the use of compensation and payment structures related to a prescription drug’s price within the retail prescription drug supply chain in part D of title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-101">42 U.S.C. 1395w–101 et seq.</external-xref>). Such study shall summarize information from Federal agencies and industry experts, to the extent available, with respect to the following:</text><subparagraph id="HE24115F382214C0FA97D29C51497FE01"><enum>(A)</enum><text>The type, magnitude, other features (such as the pricing benchmarks used), and prevalence of compensation and payment structures related to a prescription drug’s price, such as calculating fee amounts as a percentage of a prescription drug’s price, between intermediaries in the prescription drug supply chain, including—</text><clause id="H9D57D79FD6A847A792F781DF94211C30"><enum>(i)</enum><text>pharmacy benefit managers;</text></clause><clause id="H6A5E07F0DBFB40B293C07F6BBC68F6E3"><enum>(ii)</enum><text>PDP sponsors offering prescription drug plans and Medicare Advantage organizations offering MA–PD plans;</text></clause><clause id="H99CB7E42EA974B039303C8A6A48E1272"><enum>(iii)</enum><text>drug wholesalers;</text></clause><clause id="H03914656C4124099A8E466BC2CA27AE2"><enum>(iv)</enum><text>pharmacies;</text></clause><clause id="HF4AEDAC481F34E5AAC8942BCD26A95E1"><enum>(v)</enum><text>manufacturers;</text></clause><clause id="H9EAE47E7D7154718BBD1A12032C06141"><enum>(vi)</enum><text>pharmacy services administrative organizations;</text></clause><clause id="HB3195CEF3D0C4476966D851B1AFE17BE"><enum>(vii)</enum><text>brokers, auditors, consultants, and other entities that—</text><subclause id="H8D76049203C54D9287D464317D247580"><enum>(I)</enum><text>advise PDP sponsors offering prescription drug plans and Medicare Advantage organizations offering MA–PD plans regarding pharmacy benefits; or</text></subclause><subclause id="H3E0FDF930BED497587D7780CEE7A0744"><enum>(II)</enum><text>review PDP sponsor and Medicare Advantage organization contracts with pharmacy benefit managers; and</text></subclause></clause><clause id="H7B62C0B729CB458FA94ADFF9DE012FAC"><enum>(viii)</enum><text>other service providers that contract with any of the entities described in clauses (i) through (vii) that may use price-related compensation and payment structures, such as rebate aggregators (or other entities that negotiate or process price concessions on behalf of pharmacy benefit managers, plan sponsors, or pharmacies).</text></clause></subparagraph><subparagraph id="H18C9473848B14C5C8B922C29FA2B8F21"><enum>(B)</enum><text>The primary business models and compensation structures for each category of intermediary described in subparagraph (A).</text></subparagraph><subparagraph id="H907D4237265E45CBBE874CFDA5842BD5"><enum>(C)</enum><text>Variation in price-related compensation structures between affiliated entities (such as entities with common ownership, either full or partial, and subsidiary relationships) and unaffiliated entities.</text></subparagraph><subparagraph id="HC20F48380C7D43DB8101977DB072EFE6"><enum>(D)</enum><text>Potential conflicts of interest among contracting entities related to the use of prescription drug price-related compensation structures, such as the potential for fees or other payments set as a percentage of a prescription drug’s price to advantage formulary selection, distribution, or purchasing of prescription drugs with higher prices.</text></subparagraph><subparagraph id="H398B078CD0234C14976E82B8D83AAAFF"><enum>(E)</enum><text>Notable differences, if any, in the use and level of price-based compensation structures over time and between different market segments, such as under part D of title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-101">42 U.S.C. 1395w–101 et seq.</external-xref>) and the Medicaid program under title XIX of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396">42 U.S.C. 1396 et seq.</external-xref>).</text></subparagraph><subparagraph id="H7AE7B8D0D2FB450BB6412588C8690F36"><enum>(F)</enum><text>The effects of drug price-related compensation structures and alternative compensation structures on Federal health care programs and program beneficiaries, including with respect to cost-sharing, premiums, Federal outlays, biosimilar and generic drug adoption and utilization, drug shortage risks, and the potential for fees set as a percentage of a drug’s price to advantage the formulary selection, distribution, or purchasing of drugs with higher prices.</text></subparagraph><subparagraph id="HDA395EEBD0F747A1854281519FFCA353"><enum>(G)</enum><text>Other issues determined to be relevant and appropriate by the Comptroller General.</text></subparagraph></paragraph><paragraph id="HB8FCEE1D312340B38EF0369CEF7B821A"><enum>(2)</enum><header>Report</header><text>Not later than 2 years after the date of enactment of this section, the Comptroller General shall submit to Congress a report containing the results of the study conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.</text></paragraph></subsection><subsection id="H61F4AA7CDE85422EB86DF403E36A28CC"><enum>(c)</enum><header>MedPAC reports on agreements with pharmacy benefit managers with respect to prescription drug plans and MA–PD plans</header><paragraph commented="no" display-inline="no-display-inline" id="HB0742C78526C4BD0910C268D3EA6EF68"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text>The Medicare Payment Advisory Commission shall submit to Congress the following reports:</text><subparagraph id="H606A3D99718848239BDDA9C7804EB9AD"><enum>(A)</enum><header>Initial report</header><text>Not later than the first March 15 occurring after the date that is 2 years after the date on which the Secretary makes the data available to the Commission, a report regarding agreements with pharmacy benefit managers with respect to prescription drug plans and MA–PD plans. Such report shall include, to the extent practicable—</text><clause id="H48EB53DA9B3B4C9C9DA8D71A27D0821A"><enum>(i)</enum><text>a description of trends and patterns, including relevant averages, totals, and other figures for the types of information submitted;</text></clause><clause id="H83A4B29C97EC44179FC540FEC4E71C0C"><enum>(ii)</enum><text>an analysis of any differences in agreements and their effects on plan enrollee out-of-pocket spending and average pharmacy reimbursement, and other impacts; and</text></clause><clause id="H3BC34A990ED941018323566EF414E805"><enum>(iii)</enum><text>any recommendations the Commission determines appropriate.</text></clause></subparagraph><subparagraph id="H116D100D4FF24F359DA57AEA9DEF5781"><enum>(B)</enum><header>Final report</header><text>Not later than 2 years after the date on which the Commission submits the initial report under subparagraph (A), a report describing any changes with respect to the information described in subparagraph (A) over time, together with any recommendations the Commission determines appropriate.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H7F64539BD5EE480D8C227351E22E6B82"><enum>(2)</enum><header>Funding</header><text>In addition to amounts otherwise available, there is appropriated to the Medicare Payment Advisory Commission, out of any money in the Treasury not otherwise appropriated, $1,000,000 for fiscal year 2025, to remain available until expended, to carry out this subsection.</text></paragraph></subsection></section><section id="HA7BB0193F321438681A5F2B1584CCB25" section-type="subsequent-section" display-inline="no-display-inline"><enum>228.</enum><header>Requiring a separate identification number and an attestation for each off-campus outpatient department of a provider</header><subsection id="H6E15B15736254509A763B4A877E92E6A"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1833(t) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(t)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" id="H1F2FC601F6474929AB69B70B6BE3AB26" display-inline="no-display-inline"><paragraph id="H788C529DFA61430AA97AC95C32C9E2FC"><enum>(23)</enum><header>Use of unique health identifiers; attestation</header><subparagraph id="H68B95086ECD04D04BD1A91CC6D1AA002"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">No payment may be made under this subsection (or under an applicable payment system pursuant to paragraph (21)) for items and services furnished on or after January 1, 2026, by an off-campus outpatient department of a provider (as defined in subparagraph (C)) unless—</text><clause id="H4AFE760D423B4E6182220B7921E77033"><enum>(i)</enum><text>such department has obtained, and such items and services are billed under, a standard unique health identifier for health care providers (as described in section 1173(b)) that is separate from such identifier for such provider;</text></clause><clause id="H81746D5FBF09443EADB2ABC1CCC8256D"><enum>(ii)</enum><text>such provider has submitted to the Secretary, during the 2-year period ending on the date such items and services are so furnished, an initial provider-based status attestation that such department is compliant with the requirements described in section 413.65 of title 42, Code of Federal Regulations (or a successor regulation); and</text></clause><clause commented="no" display-inline="no-display-inline" id="HCAD256AF48AD4BAB965F003AE16DFDED"><enum>(iii)</enum><text>after such provider has submitted an attestation under clause (ii), such provider has submitted a subsequent attestation within the timeframe specified by the Secretary.</text></clause></subparagraph><subparagraph id="HD4C8DDE1EB1446F2B688280325CA07C4"><enum>(B)</enum><header>Process for submission and review</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of this paragraph, the Secretary shall, through notice and comment rulemaking, establish a process for each provider with an off-campus outpatient department of a provider to submit an initial and subsequent attestation pursuant to clauses (ii) and (iii), respectively, of subparagraph (A), and for the Secretary to review each such attestation and determine, through site visits, remote audits, or other means (as determined appropriate by the Secretary), whether such department is compliant with the requirements described in such subparagraph.</text></subparagraph><subparagraph id="H4FFBABB1A0BD4A6A8E698376C404C8E1"><enum>(C)</enum><header>Off-campus outpatient department of a provider defined</header><text display-inline="yes-display-inline">For purposes of this paragraph, the term <term>off-campus outpatient department of a provider</term> means a department of a provider (as defined in section 413.65 of title 42, Code of Federal Regulations, or any successor regulation) that is not located—</text><clause id="H7091569C5D274257AE8363817CF26770"><enum>(i)</enum><text display-inline="yes-display-inline">on the campus (as defined in such section) of such provider; or</text></clause><clause id="HAF959FBF7F394B3CB1911226AFA91A01"><enum>(ii)</enum><text display-inline="yes-display-inline">within the distance (described in such definition of campus) from a remote location of a hospital facility (as defined in such section).</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HDC135C681D1F407F9CFAC29599502002"><enum>(b)</enum><header>HHS OIG analysis</header><text display-inline="yes-display-inline">Not later than January 1, 2030, the Inspector General of the Department of Health and Human Services shall submit to Congress—</text><paragraph id="HE645AE61458C4DE58D9C08DC18DBF845"><enum>(1)</enum><text>an analysis of the process established by the Secretary of Health and Human Services to conduct the reviews and determinations described in section 1833(t)(23)(B) of the Social Security Act, as added by subsection (a) of this section; and</text></paragraph><paragraph id="H4E6C4811839D47D0A42F67A444A447A6" commented="no" display-inline="no-display-inline"><enum>(2)</enum><text>recommendations based on such analysis, as the Inspector General determines appropriate. </text></paragraph></subsection></section><section id="H570DEAC61540462EB8E57E7F259FB4B2" display-inline="no-display-inline" section-type="subsequent-section"><enum>229.</enum><header>Medicare sequestration</header><text display-inline="no-display-inline">Section 251A(6) of the Balanced Budget and Emergency Deficit Control Act of 1985 (<external-xref legal-doc="usc" parsable-cite="usc/2/901a">2 U.S.C. 901a(6)</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H5FF5D113CB48400EA22AD5154D5FBC44"><enum>(1)</enum><text>in subparagraph (D), by striking <quote>such that,</quote> and all that follows and inserting <quote>such that the payment reduction shall be 2.0 percent.</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3B3EF862F9EE47DBAAB610FDB161B80A"><enum>(2)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HD4FEEC7CC4E84068AC6F2B1D225E66D0"><subparagraph commented="no" display-inline="no-display-inline" id="HDAEF8B0BD0A24C928D101B0A5517EFC6" indent="up1"><enum>(F)</enum><text display-inline="yes-display-inline">On the date on which the President submits the budget under section 1105 of title 31, United States Code, for fiscal year 2033, the President shall order a sequestration of payments for the Medicare programs specified in section 256(d), effective upon issuance, such that, notwithstanding the 2 percent limit specified in subparagraph (A) for such payments—</text><clause commented="no" display-inline="no-display-inline" id="HB971E2A9A3044CD49960FC294C11CCF8"><enum>(i)</enum><text>with respect to the first 2 months in which such order is effective for such fiscal year, the payment reduction shall be 2.0 percent; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H5DE9754173CC4D3D859BBA96ED386015"><enum>(ii)</enum><text>with respect to the last 10 months in which such order is effective for such fiscal year, the payment reduction shall be 0 percent.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section></title><title id="H30C4F27C4C454D109F079D3BAD8EEA49"><enum>III</enum><header>Other matters</header><section id="H7C506C7A693C4F1AA9C3C6CB53C8718D"><enum>301.</enum><header>Sexual risk avoidance education extension</header><text display-inline="no-display-inline">Section 510 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/710">42 U.S.C. 710</external-xref>) is amended—</text><paragraph id="H92FC6452D7F946E089B7F96DFB7BBD3B"><enum>(1)</enum><text>in subsection (a)—</text><subparagraph id="H8F19E63128E04CD5817DB9ABE2FDBED8"><enum>(A)</enum><text>in paragraph (1)—</text><clause id="H4A564441489B40E6AF61DCFDCD35ACBF" display-inline="no-display-inline"><enum>(i)</enum><text>by striking <quote>and for the period</quote> and inserting <quote>for the period</quote>;</text></clause><clause id="HF9C040C69D8E4332A962EA440146ECAF"><enum>(ii)</enum><text>by striking <quote>March 31, 2025</quote> and inserting <quote>September 30, 2025</quote>;</text></clause><clause id="H6BF63A3C91FC4DA1AE6C8FEA2AE69B4C"><enum>(iii)</enum><text>by inserting <quote>and for the period beginning on October 1, 2025, and ending on December 31, 2025,</quote> before <quote>allot to each State</quote>; and </text></clause><clause id="H44D09DF4D0704803911BE5683913F917"><enum>(iv)</enum><text>by striking <quote>for fiscal year 2024 or 2025</quote> and inserting <quote>for fiscal year 2024, 2025, or 2026</quote>; and</text></clause></subparagraph><subparagraph id="H2C7E51524DE84A9EAD017ED1B36273DD"><enum>(B)</enum><text>in paragraph (2), by striking <quote>or 2025</quote> each place it appears and inserting <quote>, 2025, or 2026</quote>; and </text></subparagraph></paragraph><paragraph id="HB4911528EB67493FA142C992A346AD4E"><enum>(2)</enum><text>in subsection (f)(1)—</text><subparagraph id="H923695E050914CF28D534627E26B45CB"><enum>(A)</enum><text>by striking <quote>and for the period</quote> and inserting <quote>for the period</quote>;</text></subparagraph><subparagraph id="H1CDB8F65E8AD40018E5C2B926351AA4E"><enum>(B)</enum><text>by striking <quote>March 31, 2025</quote> and inserting <quote>September 30, 2025</quote>; and</text></subparagraph><subparagraph id="H50859B3899F5418C87071B616D002465"><enum>(C)</enum><text>by inserting <quote>, and for the period beginning on October 1, 2025, and ending on December 31, 2025, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2025</quote> after <quote>corresponding period for fiscal year 2024</quote>. </text></subparagraph></paragraph></section><section id="H5D739B7348B34B1A8B146A958E406F5A"><enum>302.</enum><header>Personal responsibility education extension</header><text display-inline="no-display-inline">Section 513 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/713">42 U.S.C. 713</external-xref>) is amended—</text><paragraph id="H893F22674FF842C7AAE3512B5B379215"><enum>(1)</enum><text>in subsection (a)(1)—</text><subparagraph id="H81822C559ECE403B9CC8491A4CC15330"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A), in the matter preceding clause (i)—</text><clause id="HFC8A75728CE343EEA946D2062D17612A" display-inline="no-display-inline"><enum>(i)</enum><text>by striking <quote>and for the period</quote> and inserting <quote>for the period</quote>;</text></clause><clause id="HB5EF9B401D0345939AA8C6522AEB5E78"><enum>(ii)</enum><text>by striking <quote>March 31, 2025</quote> and inserting <quote>September 30, 2025</quote>; and</text></clause><clause id="H6E55AF76A77C47888238818736E659EA"><enum>(iii)</enum><text>by inserting <quote>and for the period beginning on October 1, 2025, and ending on December 31, 2025,</quote> before <quote>the Secretary shall allot</quote>; and </text></clause></subparagraph><subparagraph id="H26B9ACEE761242C69067CEDA3F2329D2"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (B)(i)—</text><clause id="H46B94B83331F4FBA8A276D73C94DA3E3" display-inline="no-display-inline"><enum>(i)</enum><text>by striking <quote>and for the period</quote> and inserting <quote>for the period</quote>;</text></clause><clause id="HCC36719FB4D74BBAA1609E33C5AB587F"><enum>(ii)</enum><text>by striking <quote>March 31, 2025</quote> and inserting <quote>September 30, 2025</quote>; and</text></clause><clause id="H464B4C13F0AD4622A29FC5A703D976AC"><enum>(iii)</enum><text>by inserting <quote>, and for the period beginning on October 1, 2025, and ending on December 31, 2025</quote> before the period;</text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3E5153B6C99A42018E41EC3012F1E96F"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (c)(3), by striking <quote>fiscal year 2024 or 2025</quote> and inserting <quote>fiscal year 2024, 2025, or 2026</quote>; and</text></paragraph><paragraph id="HBEB1701937DA4A8AAADF2466265B36B3"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (f)—</text><subparagraph id="H40A30E93E801410DBCA1E85AFD099512"><enum>(A)</enum><text>by striking <quote>and for the period</quote> and inserting <quote>for the period</quote>;</text></subparagraph><subparagraph id="H1C03B36927C746F9A8DD8FAB743A1FFE"><enum>(B)</enum><text>by striking <quote>March 31, 2025</quote> and inserting <quote>September 30, 2025</quote>; and</text></subparagraph><subparagraph id="H940749C0BA764C85996D5EC7D02408EB"><enum>(C)</enum><text>by inserting <quote>, and for the period beginning on October 1, 2025, and ending on December 31, 2025, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2025</quote> after <quote>corresponding period for fiscal year 2024</quote>. </text></subparagraph></paragraph></section><section id="H695DB300FC954238867DE2E2E27CA80E"><enum>303.</enum><header>Extension of funding for family-to-family health information centers</header><text display-inline="no-display-inline">Section 501(c)(1)(A)(viii) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/701">42 U.S.C. 701(c)(1)(A)(viii)</external-xref>) is amended—</text><paragraph id="HFDC5123AA083419AA19D9034F6943B44"><enum>(1)</enum><text>by striking <quote>$3,000,000</quote> and inserting <quote>$7,500,000</quote>; and</text></paragraph><paragraph id="H3FC3C374D4A448BFA0ECFC927A7CD912" commented="no" display-inline="no-display-inline"><enum>(2)</enum><text>by striking <quote>for the portion of fiscal year 2025 before April 1, 2025</quote> and inserting <quote>for the period beginning on October 1, 2024, and ending on December 31, 2025</quote>.</text></paragraph></section></title><title id="H34C6A2B454A6476F8F0395B264275D6D"><enum>IV</enum><header>Public health extenders</header><subtitle id="H76BF759FB61F4F97930791EFB0AF7F93"><enum>A</enum><header>Extensions</header><section id="HDC2F2034040E4E1F9F487313A68FB7F2"><enum>401.</enum><header>Extension for community health centers, National Health Service Corps, and teaching health centers that operate GME programs</header><subsection id="H96CB8460C59C4F4B9CA7C2C434E26E1B" commented="no"><enum>(a)</enum><header>Extension for community health centers</header><text display-inline="yes-display-inline">Section 10503(b)(1) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254b-2">42 U.S.C. 254b–2(b)(1)</external-xref>) is amended—</text><paragraph id="H084CE80C154A4750822B6E7CCF74D58B" commented="no"><enum>(1)</enum><text>in subparagraph (H), by striking <quote>and</quote> at the end;</text></paragraph><paragraph id="H34BC69EB104A4B598479F87EF9B0CBD5" commented="no"><enum>(2)</enum><text>in subparagraph (I), by striking the period at the end and inserting a semicolon; and</text></paragraph><paragraph id="HFD7FE7BB0CDD4E24BE2A51C3664EE77E" commented="no"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" id="HEAD5922F828C400F9BDC73DFF1A2DE2C" display-inline="no-display-inline"><subparagraph id="HD90C968E41C246EBA043BD30945E5782" commented="no"><enum>(J)</enum><text display-inline="yes-display-inline">$2,315,342,466 for the period beginning on April 1, 2025, and ending on September 30, 2025; and</text></subparagraph><subparagraph id="H2A2784B2161F4E838FC9B897625B244E" commented="no"><enum>(K)</enum><text display-inline="yes-display-inline">$4,600,000,000 for fiscal year 2026; and</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H96B0ACE7836E401DB730954AA4BFF31C" commented="no"><enum>(b)</enum><header>Extension for the National Health Service Corps</header><text display-inline="yes-display-inline">Section 10503(b)(2) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254b-2">42 U.S.C. 254b–2(b)(2)</external-xref>) is amended—</text><paragraph id="HE5515C46587B47AFA120005D50C2762F" commented="no"><enum>(1)</enum><text>in subparagraph (I), by striking <quote>and</quote> at the end; </text></paragraph><paragraph id="H23BDF7BEFEA64251AC03894DEA92DFA8" commented="no"><enum>(2)</enum><text>in subparagraph (J), by striking the period at the end and inserting a semicolon; and</text></paragraph><paragraph id="H91BB0941361F43EDBA835FAEFC96DB8E" commented="no"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" id="HA475F91D2BF841E38302CD511E46A1F5" display-inline="no-display-inline"><subparagraph id="HD0AAF70D56F24917BB5591D0DCF4E8EF" commented="no"><enum>(K)</enum><text display-inline="yes-display-inline">$176,712,329 for the period beginning on April 1, 2025, and ending on September 30, 2025; and</text></subparagraph><subparagraph id="H9EA9FE6F3DD143A086664FF43AE3E684" commented="no"><enum>(L)</enum><text display-inline="yes-display-inline">$350,000,000 for fiscal year 2026.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H8FF8FCF69EF24656A8A31BA6F8B93D99" commented="no"><enum>(c)</enum><header>Teaching health centers that operate graduate medical education programs</header><text display-inline="yes-display-inline">Section 340H(g)(1) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/256h">42 U.S.C. 256h(g)(1)</external-xref>) is amended—</text><paragraph id="HC86E8E7E83E8492E91D6F845A1E78E5A" commented="no"><enum>(1)</enum><text>in subparagraph (D), by striking <quote>and</quote> at the end;</text></paragraph><paragraph id="H68ADF84CE3B448C382EE5CA906053115" commented="no"><enum>(2)</enum><text>in subparagraph (E), by striking the period at the end and inserting a semicolon; and</text></paragraph><paragraph id="H8C8694C9F8A94643B900BDF9B5E21A24" commented="no"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" id="H0E8ABF46D1DD486CA214BFDA581B63AA" display-inline="no-display-inline"><subparagraph id="HC0D6BD6564544A75A2DD532D8AF874B3" commented="no"><enum>(F)</enum><text display-inline="yes-display-inline">$112,849,315 for the period beginning on April 1, 2025, and ending on September 30, 2025;</text></subparagraph><subparagraph id="H210201B9FDC5489E8EC92077223EC3EC" commented="no"><enum>(G)</enum><text display-inline="yes-display-inline">$225,000,000 for fiscal year 2026;</text></subparagraph><subparagraph id="HED5D7AF10AD44402A7707E6975B5064A" commented="no"><enum>(H)</enum><text display-inline="yes-display-inline">$250,000,000 for fiscal year 2027;</text></subparagraph><subparagraph id="H9B173EB01AC3469B92718197701F6F57" commented="no"><enum>(I)</enum><text display-inline="yes-display-inline">$275,000,000 for fiscal year 2028; and</text></subparagraph><subparagraph id="H911C695BE24C4033BA53D9BE90D4B3DC" commented="no"><enum>(J)</enum><text display-inline="yes-display-inline">$300,000,000 for fiscal year 2029.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H1CD15F7D19054C9CA55047C55527E585"><enum>(d)</enum><header>Application of provisions</header><text>Amounts appropriated pursuant to the amendments made by this section shall be subject to the requirements contained in <external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref> for funds for programs authorized under sections 330 through 340 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254b">42 U.S.C. 254b et seq.</external-xref>).</text></subsection><subsection id="HD2EF018FE3CE404DAC59392609278234" commented="no"><enum>(e)</enum><header>Conforming amendment</header><text display-inline="yes-display-inline">Section 3014(h)(4) of title 18, United States Code, is amended by striking <quote>and section 3101(d) of the Health Extensions and Other Matters Act, 2025</quote> and inserting <quote>section 3101(d) of the Health Extensions and Other Matters Act, 2025, and section 401 of the Lower Costs for Everyday Americans Act</quote>.</text></subsection></section><section id="H40FAE07971544FAD9921EC523106A7A7"><enum>402.</enum><header>Extension of special diabetes programs</header><subsection id="HC4E145B9E45C4CA4A412D69B4AE2C3C2" commented="no"><enum>(a)</enum><header>Extension of special diabetes programs for type I diabetes</header><text>Section 330B(b)(2) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254c-2">42 U.S.C. 254c–2(b)(2)</external-xref>) is amended—</text><paragraph id="H8672524AC8F74D4F9B757719D94CE36D" commented="no"><enum>(1)</enum><text>in subparagraph (E), by striking <quote>and</quote> at the end;</text></paragraph><paragraph id="H16D20285C7B74AB1930D5FA3C211EFA7" commented="no"><enum>(2)</enum><text>in subparagraph (F), by striking the period at the end and inserting a semicolon; and</text></paragraph><paragraph id="H88411FECA113459DB2D5715964048494" commented="no"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" id="H8E72A7CC44914BF686B4320350FC819C" display-inline="no-display-inline"><subparagraph id="H6B508D115F284659A3C773D5AFA373E6" commented="no"><enum>(G)</enum><text display-inline="yes-display-inline">$110,327,296 for the period beginning on April 1, 2025, and ending on September 30, 2025, to remain available until expended; and</text></subparagraph><subparagraph id="H97E6C5B9E7494E4EB55512B5DEEFA488" commented="no"><enum>(H)</enum><text>$200,000,000 for fiscal year 2026, to remain available until expended.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H4110327E5BFF4CCFB1702D82345B2F78" commented="no"><enum>(b)</enum><header>Extending funding for special diabetes programs for Indians</header><text>Section 330C(c)(2) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254c-3">42 U.S.C. 254c–3(c)(2)</external-xref>) is amended—</text><paragraph id="H1E0167DE222D445A92087972A5A82A8B" commented="no"><enum>(1)</enum><text>in subparagraph (E), by striking <quote>and</quote> at the end; </text></paragraph><paragraph id="HBAFABFCB11644635A974DFB502135D70" commented="no"><enum>(2)</enum><text>in subparagraph (F), by striking the period at the end and inserting a semicolon; and</text></paragraph><paragraph id="HACB3EFB58E34428F9D880FBFB28EFD37" commented="no"><enum>(3)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text><quoted-block style="OLC" id="HE0435C9265504B309FE2A3B5B1B7C27A" display-inline="no-display-inline"><subparagraph id="H7F1E9A8D6B8743C8914EB2969F83A3BA" commented="no"><enum>(G)</enum><text display-inline="yes-display-inline">$110,327,296 for the period beginning on April 1, 2025, and ending on September 30, 2025, to remain available until expended; and</text></subparagraph><subparagraph id="H4DC9E91CC5A549A3A2F78435A1A4CB0B" commented="no"><enum>(H)</enum><text display-inline="yes-display-inline">$200,000,000 for fiscal year 2026, to remain available until expended.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section></subtitle><subtitle id="H72E9F6277EB549068FDB911A847348A6" style="OLC"><enum>B</enum><header>World Trade Center Health Program</header><section id="H7CBB7A6E0A784133A77D7D56D854AA00"><enum>411.</enum><header>9/11 responder and survivor health funding corrections</header><subsection id="H8A537696D66346118FAE791AD3E3F0A1"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 3351(a)(2)(A) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300mm-61">42 U.S.C. 300mm–61(a)(2)(A)</external-xref>) is amended—</text><paragraph id="HB63C86DD63F34AD9AC4CE285391E087C"><enum>(1)</enum><text>in clause (x), by striking <quote>; and</quote> and inserting a semicolon;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HECFA91872C004072A6A5C049FD23E443"><enum>(2)</enum><text>by redesignating clause (xi) as clause (xii); and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC69B443DCCCA4920932038D9BE8B7503"><enum>(3)</enum><text>by inserting after clause (x), the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H916D02FF60BE47DE826051380114D215"><clause id="H5699E1EC7E9F4AC9916270292516A406"><enum>(xi)</enum><text>for each of fiscal years 2026 through 2040— </text><subclause id="H0F31EE5E4FEC49E298955E8ADED63CB4"><enum>(I)</enum><text>the amount determined under this subparagraph for the previous fiscal year multiplied by 1.05; multiplied by</text></subclause><subclause id="H13E8DE56302B4500AA787BC82D89DD0F"><enum>(II)</enum><text>the ratio of—</text><item id="HB7C62BF059D64F848EE9086349B6FEEF"><enum>(aa)</enum><text>the total number of individuals enrolled in the WTC Program on July 1 of such previous fiscal year; to </text></item><item id="HA5F1F127CE0E4BD8AC9CD872B8BECD19"><enum>(bb)</enum><text>the total number of individuals so enrolled on July 1 of the fiscal year prior to such previous fiscal year; and</text></item></subclause></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H258332B789CB4E108813F4264A7B090E"><enum>(b)</enum><header>Report to Congress</header><paragraph id="H2C7FF86AB5104657ADFE758A1CB0C3EE"><enum>(1)</enum><header>In general</header><text>Not later than 3 years after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the <quote>Secretary</quote>) shall conduct an assessment of anticipated budget authority and outlays of the World Trade Center Health Program (referred to in this subsection as the <quote>Program</quote>) through the duration of the Program and submit a report summarizing such assessment to—</text><subparagraph id="H274D0AEA414E40318EA6453E969EB91C"><enum>(A)</enum><text>the Speaker and minority leader of the House of Representatives;</text></subparagraph><subparagraph id="H79F7C10AED714694A49726CADFCBB6D8"><enum>(B)</enum><text>the majority and minority leaders of the Senate;</text></subparagraph><subparagraph id="HFDA605D59535473A9E0EF049462673FD"><enum>(C)</enum><text>the Committee on Health, Education, Labor, and Pensions and Committee on the Budget of the Senate; and</text></subparagraph><subparagraph id="H4805A4DF2B9E48F595E6EC522C09FA14"><enum>(D)</enum><text>the Committee on Energy and Commerce and the Committee on the Budget of the House of Representatives.</text></subparagraph></paragraph><paragraph id="HF693F4C30DA945E3B9E7206B4AA3676C"><enum>(2)</enum><header>Inclusions</header><text>The report required under paragraph (1) shall include—</text><subparagraph id="H4C2D87F7F7C4479C86588B3F0FBB42F5"><enum>(A)</enum><text>a projection of Program budgetary needs on a per-fiscal year basis through fiscal year 2090;</text></subparagraph><subparagraph id="H53631436ED2C44EA8908A78ED4C84CD6"><enum>(B)</enum><text>a review of Program modeling for each of fiscal years 2017 through the fiscal year prior to the fiscal year in which the report is issued to assess how anticipated budgetary needs compared to actual expenditures;</text></subparagraph><subparagraph id="H0F88C866750D462BA8D774B4BE1D373C"><enum>(C)</enum><text>an assessment of the projected budget authority and expenditures of the Program through fiscal year 2090 by comparing—</text><clause id="HABE4D03F2DFF4EA493698994FB4730B8"><enum>(i)</enum><text>such projected authority and expenditures resulting from application of section 3351(a)(2)(A) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300mm-61">42 U.S.C. 300mm–61(a)(2)(A)</external-xref>), as amended by subsection (a); </text></clause><clause id="H546CD7DA90934FC9902222CC21088B2F"><enum>(ii)</enum><text>such projected authority and expenditures that would result if such section were amended so that the formula under clause (xi) of such section, as amended by subsection (a), were to be extended through fiscal year 2090; and</text></clause></subparagraph><subparagraph id="H8DFD2C316FE1484281FE5F29BE1F4671"><enum>(D)</enum><text>any recommendations of the Secretary to make changes to the formula under such section 3351(a)(2)(A), as so amended, to fully offset anticipated Program expenditures through fiscal year 2090. </text></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H5E5AE70C801F488586D1F46F084BB23A"><enum>(c)</enum><header display-inline="yes-display-inline">Technical amendments</header><text>Title XXXIII of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300mm">42 U.S.C. 300mm et seq.</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H11871F41553D4142A9EEC99E2696FB93"><enum>(1)</enum><text display-inline="yes-display-inline">in section 3352(d) (<external-xref legal-doc="usc" parsable-cite="usc/42/300mm-62">42 U.S.C. 300mm–62(d)</external-xref>), by striking <quote>Any amounts</quote> and inserting <quote>Any unobligated amounts</quote>;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF8C7D0C13DB04E608AFC95C3A112A6BE"><enum>(2)</enum><text>in section 3353(d) (<external-xref legal-doc="usc" parsable-cite="usc/42/300mm-63">42 U.S.C. 300mm–63(d)</external-xref>), by striking <quote>Any amounts</quote> and inserting <quote>Any unobligated amounts</quote>; and</text></paragraph><paragraph id="H8DC0F60B14C443E9BF3F1E1734C18392" commented="no" display-inline="no-display-inline"><enum>(3)</enum><text>in section 3354(d) (<external-xref legal-doc="usc" parsable-cite="usc/42/300mm-64">42 U.S.C. 300mm–64(d)</external-xref>), by striking <quote>Any amounts</quote> and inserting <quote>Any unobligated amounts</quote>.</text></paragraph></subsection></section></subtitle></title><title id="H1211338397CA458E8C259988AC71C2D1"><enum>V</enum><header>SUPPORT Act Reauthorization</header><section id="HF6A5B709598F4ED2885CDDC3D69A5FDA"><enum>501.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>SUPPORT for Patients and Communities Reauthorization Act of 2025</short-title></quote>.</text></section><subtitle id="H772A457722E1464189900965EB95A79D"><enum>A</enum><header>Prevention</header><section id="H91B761EAD4274B54A1E559C25F15BCC2"><enum>511.</enum><header>Prenatal and postnatal health</header><text display-inline="no-display-inline">Section 317L(d) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-13">42 U.S.C. 247b–13(d)</external-xref>) is amended by striking <quote>such sums as may be necessary for each of the fiscal years 2019 through 2023</quote> and inserting <quote>$4,250,000 for each of fiscal years 2025 through 2029</quote>.</text></section><section id="HF493DF7918224450AD977FFDBDB1C4EC"><enum>512.</enum><header>Monitoring and education regarding infections associated with illicit drug use and other risk factors</header><text display-inline="no-display-inline">Section 317N(d) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-15">42 U.S.C. 247b–15(d)</external-xref>) is amended by striking <quote>fiscal years 2019 through 2023</quote> and inserting <quote>fiscal years 2025 through 2029</quote>.</text></section><section id="H2CC393411220484A99F781085F3E7DF9" commented="no"><enum>513.</enum><header>Preventing overdoses of controlled substances</header><subsection id="HED2777CDC45044348AAD83351EAC9E91" commented="no"><enum>(a)</enum><header>In general</header><text>Section 392A of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280b-1">42 U.S.C. 280b–1</external-xref>) is amended—</text><paragraph id="H3F7802C3844E4019B210E451C41CEE63" commented="no"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)(2)—</text><subparagraph id="HED8C08A0119C4264A88E08BC82AE1E7A"><enum>(A)</enum><text>in subparagraph (C), by inserting <quote>and associated risks</quote> before the period at the end; and</text></subparagraph><subparagraph id="HD75FF7A44BB04ECBA99F3D330C3A63AB"><enum>(B)</enum><text>in subparagraph (D), by striking <quote>opioids</quote> and inserting <quote>substances causing overdose</quote>; and</text></subparagraph></paragraph><paragraph id="H3DA8DBE2DFA747179C76C83D0FCD40B7" commented="no"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)(2)—</text><subparagraph id="HA84F01612ABF48D0BCEDF24EFCE8D532" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (B), by inserting <quote>, and associated risk factors,</quote> after <quote>such overdoses</quote>;</text></subparagraph><subparagraph id="H6A619B4E2D784F3A9BCA8B221B3371CD" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (C), by striking <quote>coding</quote> and inserting <quote>monitoring and identifying</quote>;</text></subparagraph><subparagraph id="H94C1EFEB71CB4F858184C3AEC16F26CE" commented="no"><enum>(C)</enum><text display-inline="yes-display-inline">in subparagraph (E)—</text><clause id="HD6A2D64723204CCF836FF237F43191A1" commented="no"><enum>(i)</enum><text display-inline="yes-display-inline">by inserting a comma after <quote>public health laboratories</quote>; and</text></clause><clause id="H50E86940C5F348F0BA52A5CAED3DB0B0" commented="no"><enum>(ii)</enum><text display-inline="yes-display-inline">by inserting <quote>and other emerging substances related</quote> after <quote>analogues</quote>; and</text></clause></subparagraph><subparagraph id="H33F4CB9FF714469C8D3BB20E50EC6E98" commented="no"><enum>(D)</enum><text display-inline="yes-display-inline">in subparagraph (F), by inserting <quote>and associated risk factors</quote> after <quote>overdoses</quote>.</text></subparagraph></paragraph></subsection><subsection id="HB8E2E9114D9C4A949AB14C26A4722474" commented="no"><enum>(b)</enum><header>Additional grants</header><text>Section 392A(a)(3) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280b-1">42 U.S.C. 280b–1(a)(3)</external-xref>) is amended—</text><paragraph id="H9185BFA6585542D898F8C559863A72D1" commented="no"><enum>(1)</enum><text>in the matter preceding subparagraph (A), by striking <quote>and Indian Tribes—</quote> and inserting <quote>and Indian Tribes for the following purposes:</quote>;</text></paragraph><paragraph id="H61736FCF0ED2494BBAC04049E87B197F" commented="no"><enum>(2)</enum><text>by amending subparagraph (A) to read as follows:</text><quoted-block style="OLC" id="H0384E92C7422432C915D460B86E285D3" display-inline="no-display-inline"><subparagraph id="H38B91A92606E4A2C86EC7436CF593FFA" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">To carry out innovative projects for grantees to detect, identify, and rapidly respond to controlled substance misuse, abuse, and overdoses, and associated risk factors, including changes in patterns of such controlled substance use. Such projects may include the use of innovative, evidence-based strategies for detecting such patterns, such as wastewater surveillance, if proven to support actionable prevention strategies, in a manner consistent with applicable Federal and State privacy laws.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="HA0778C80FB7D4CFA93D00EED5CF336F6" commented="no"><enum>(3)</enum><text>in subparagraph (B), by striking <quote>for any</quote> and inserting <quote>For any</quote>. </text></paragraph></subsection><subsection id="HF05F06E9FF4544088FD39E36ED693374" commented="no"><enum>(c)</enum><header>Authorization of appropriations</header><text>Section 392A(e) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280b-1">42 U.S.C. 280b–1(e)</external-xref>) is amended by striking <quote>$496,000,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$505,579,000 for each of fiscal years 2025 through 2029</quote>.</text></subsection></section><section id="HF24123FEECDD4399934B3EBE89662C57"><enum>514.</enum><header>Support for individuals and families impacted by fetal alcohol spectrum disorder</header><subsection id="HE9BE31C354EB4BB584A27A83197395BE"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Part O of title III of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280f">42 U.S.C. 280f et seq.</external-xref>) is amended to read as follows:</text><quoted-block style="OLC" id="HC48371BE5DF04E7F8C06717A4EC67B3A" display-inline="no-display-inline"><part id="H73CE12A538174157AC261D0D450D5E7A"><enum>O</enum><header>FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM</header><section id="H4C6B98A6F537446D94ECE6A406FACB76"><enum>399H.</enum><header>Fetal alcohol spectrum disorders prevention, intervention, and services delivery program</header><subsection id="HD5DAF77195A448699D19F53A2143F0B3"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall establish or continue activities to support a comprehensive fetal alcohol spectrum disorders (referred to in this section as <quote>FASD</quote>) education, prevention, identification, intervention, and services delivery program, which may include—</text><paragraph id="H5547F5F5E6974EB0B4A342289D5590FB"><enum>(1)</enum><text>an education and public awareness program to support, conduct, and evaluate the effectiveness of—</text><subparagraph id="HD239A56335844DAE9ACB2EFA3A77D67F"><enum>(A)</enum><text display-inline="yes-display-inline">educational programs targeting health professions schools, social and other supportive services, educators and counselors and other service providers in all phases of childhood development, and other relevant service providers, concerning the prevention, identification, and provision of services for infants, children, adolescents and adults with FASD;</text></subparagraph><subparagraph id="H26A2A636087B40B1892D50D27B304FC1"><enum>(B)</enum><text>strategies to educate school-age children, including pregnant and high-risk youth, concerning FASD;</text></subparagraph><subparagraph id="HDA0D3D950C4F407E8B7EF8E809A98816"><enum>(C)</enum><text>public and community awareness programs concerning FASD; and</text></subparagraph><subparagraph id="H029887DD0C944DE9B7DD581046A10221"><enum>(D)</enum><text display-inline="yes-display-inline">strategies to coordinate information and services across affected community agencies, including agencies providing social services such as foster care, adoption, and social work, agencies providing health services, and agencies involved in education, vocational training and civil and criminal justice;</text></subparagraph></paragraph><paragraph id="H4096C4E231F8448D8B190FA04BDF4666"><enum>(2)</enum><text display-inline="yes-display-inline">supporting and conducting research on FASD, as appropriate, including to—</text><subparagraph id="HED72E28BFE5C410BB84E1802CC9A0349"><enum>(A)</enum><text>develop appropriate medical diagnostic methods for identifying FASD; and</text></subparagraph><subparagraph id="HCDD4199DA4CD49269565F84A7C1434D7"><enum>(B)</enum><text display-inline="yes-display-inline">develop effective culturally and linguistically appropriate evidence-based or evidence-informed interventions and appropriate supports for preventing prenatal alcohol exposure, which may co-occur with exposure to other substances;</text></subparagraph></paragraph><paragraph id="H47FA2F6C05B44E239E48CABEB849E7A7"><enum>(3)</enum><text display-inline="yes-display-inline">building State and Tribal capacity for the identification, treatment, and support of individuals with FASD and their families, which may include—</text><subparagraph id="HC829339635744DAB9DE2EF9D86F9DC1D"><enum>(A)</enum><text>utilizing and adapting existing Federal, State, or Tribal programs to include FASD identification and FASD-informed support;</text></subparagraph><subparagraph id="HAB2B669DC2104720999A36A5E301F2E4"><enum>(B)</enum><text>developing and expanding screening and diagnostic capacity for FASD;</text></subparagraph><subparagraph id="H48615E417A7445269A8F3097671FF60E"><enum>(C)</enum><text>developing, implementing, and evaluating targeted FASD-informed intervention programs for FASD;</text></subparagraph><subparagraph id="H83D5F7F28CB54027A63F2147D61539ED"><enum>(D)</enum><text>providing training with respect to FASD for professionals across relevant sectors; and</text></subparagraph><subparagraph id="H3E39D0BF55164EAA93DD2EAC8647B95E"><enum>(E)</enum><text>disseminating information about FASD and support services to affected individuals and their families; and</text></subparagraph></paragraph><paragraph id="HA3BA626248914C5F8F15333FAE3D3992"><enum>(4)</enum><text>an applied research program concerning intervention and prevention to support and conduct service demonstration projects, clinical studies and other research models providing advocacy, educational and vocational training, counseling, medical and mental health, and other supportive services, as well as models that integrate and coordinate such services, that are aimed at the unique challenges facing individuals with Fetal Alcohol Syndrome or Fetal Alcohol Effect and their families.</text></paragraph></subsection><subsection id="HAB86BE76239048F28D0FEEF8A576D9EE"><enum>(b)</enum><header>Grants and Technical Assistance</header><paragraph id="H1A8E63C74DED45D4BC3D26C87343944A"><enum>(1)</enum><header>In general</header><text>The Secretary may award grants, cooperative agreements and contracts and provide technical assistance to eligible entities to carry out subsection (a).</text></paragraph><paragraph id="H725481E34E3D4C2FBBDC14EB24E0D186"><enum>(2)</enum><header>Eligible entities</header><text display-inline="yes-display-inline">To be eligible to receive a grant, or enter into a cooperative agreement or contract, under this section, an entity shall—</text><subparagraph id="HDAFF419520F84DEE9083279DB9C00B0D"><enum>(A)</enum><text>be a State, Indian Tribe or Tribal organization, local government, scientific or academic institution, or nonprofit organization; and</text></subparagraph><subparagraph id="H6AD787AC6428406ABA1E2A04DB664462"><enum>(B)</enum><text>prepare and submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a description of the activities that the entity intends to carry out using amounts received under this section.</text></subparagraph></paragraph><paragraph id="H54C48DF93D3B4403B248019307D5261C"><enum>(3)</enum><header>Additional application contents</header><text>The Secretary may require that an eligible entity include in the application submitted under paragraph (2)(B)—</text><subparagraph id="H32BD630F63584A6896777FB2B853A96A"><enum>(A)</enum><text>a designation of an individual to serve as a FASD State or Tribal coordinator of activities such eligible entity proposes to carry out through a grant, cooperative agreement, or contract under this section; and</text></subparagraph><subparagraph id="H289C08A2DA024F7A844CD6BF4177D1D6"><enum>(B)</enum><text>a description of an advisory committee the entity will establish to provide guidance for the entity on developing and implementing a statewide or Tribal strategic plan to prevent FASD and provide for the identification, treatment, and support of individuals with FASD and their families.</text></subparagraph></paragraph></subsection><subsection id="H3287C0A9A1E54B2D8C3591CAA6C7F346"><enum>(c)</enum><header>Definition of FASD-Informed</header><text display-inline="yes-display-inline">For purposes of this section, the term <term>FASD-informed</term>, with respect to support or an intervention program, means that such support or intervention program uses culturally and linguistically informed evidence-based or practice-based interventions and appropriate resources to support an improved quality of life for an individual with FASD and the family of such individual.</text></subsection></section><section id="H0321BE9C13F44F3997776B08BA11B80D"><enum>399I.</enum><header>Strengthening capacity and education for fetal alcohol spectrum disorders</header><subsection id="H6E468D6D7E6B4206950F706BE40F5BD9"><enum>(a)</enum><header>In general</header><text>The Secretary shall award grants, contracts, or cooperative agreements, as the Secretary determines appropriate, to public or nonprofit private entities with demonstrated expertise in the field of fetal alcohol spectrum disorders (referred to in this section as <quote>FASD</quote>). Such awards shall be for the purposes of building local, Tribal, State, and nationwide capacities to prevent the occurrence of FASD by carrying out the programs described in subsection (b).</text></subsection><subsection id="H86E5BB1AEABF4FB982492DB1A752917C"><enum>(b)</enum><header>Programs</header><text>An entity receiving an award under subsection (a) may use such award for the following purposes:</text><paragraph id="HCFC3A7F2D0774C61BD4CA763580583C2"><enum>(1)</enum><text>Developing and supporting public education and outreach activities to raise public awareness of the risks associated with alcohol consumption during pregnancy.</text></paragraph><paragraph id="HC3EA6EAB10B9408A86DE76C0E5ED797B"><enum>(2)</enum><text>Acting as a clearinghouse for evidence-based resources on FASD prevention, identification, and culturally and linguistically appropriate best practices to help inform systems of care for individuals with FASD across their lifespan.</text></paragraph><paragraph id="HE092D40DCCB44E638736DB8B1944E344"><enum>(3)</enum><text>Increasing awareness and understanding of efficacious, evidence-based screening tools and culturally and linguistically appropriate evidence-based intervention services and best practices, which may include improving the capacity for State, Tribal, and local affiliates.</text></paragraph><paragraph id="H5D39239999AA46019AAFE6D950B9B2BB"><enum>(4)</enum><text>Providing technical assistance to recipients of grants, cooperative agreements, or contracts under section 399H, as appropriate.</text></paragraph></subsection><subsection id="H6D111BE7EB4043E781BE87CF2CF61791"><enum>(c)</enum><header>Application</header><text>To be eligible for a grant, contract, or cooperative agreement under this section, an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.</text></subsection><subsection id="H660FCC209FE94CB79D8DAE9E4B28B313"><enum>(d)</enum><header>Subcontracting</header><text>A public or private nonprofit entity may carry out the following activities required under this section through contracts or cooperative agreements with other public and private nonprofit entities with demonstrated expertise in FASD:</text><paragraph id="H5FF6DE0342FF4D2FB9AA29185F7C5D8A"><enum>(1)</enum><text>Resource development and dissemination.</text></paragraph><paragraph id="HA915516E0C1A409E9ADAFD0C5FE0487C"><enum>(2)</enum><text>Intervention services.</text></paragraph><paragraph id="HF27EED982976426ABB47F72CC59E7A54"><enum>(3)</enum><text>Training and technical assistance.</text></paragraph></subsection></section><section id="HA1153F792AC24FB093107324DF3A5776"><enum>399J.</enum><header>Authorization of appropriations</header><text display-inline="no-display-inline">There are authorized to be appropriated to carry out this part $12,500,000 for each of fiscal years 2025 through 2029.</text></section></part><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HD5DBE6D43A4B48649850B9552222B39D"><enum>(b)</enum><header>Report</header><text>Not later than 4 years after the date of enactment of this Act, and every year thereafter, the Secretary of Health and Human Services 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 containing—</text><paragraph id="HC184CE27AFAE4F7ABFD7E98EAC7A6C64"><enum>(1)</enum><text>a review of the activities carried out pursuant to sections 399H and 399I of the Public Health Service Act, as amended, to advance public education and awareness of fetal alcohol spectrum disorders (referred to in this section as <quote>FASD</quote>);</text></paragraph><paragraph id="H9F5D4D2164A24985AF328C4813D41376"><enum>(2)</enum><text>a description of—</text><subparagraph id="HFF7B7B77EED1402191FC605921BB7414"><enum>(A)</enum><text>the activities carried out pursuant to such sections 399H and 399I to identify, prevent, and treat FASD; and</text></subparagraph><subparagraph id="HAFF262C5C0374FF296D795ED384727D5"><enum>(B)</enum><text>methods used to evaluate the outcomes of such activities; and</text></subparagraph></paragraph><paragraph id="H3047D5F5B72E476EAE7E34687EDE5133"><enum>(3)</enum><text>an assessment of activities carried out pursuant to such sections 399H and 399I to support individuals with FASD.</text></paragraph></subsection></section><section id="HE5C66D1E87914357A0858C19CEA29049"><enum>515.</enum><header>Promoting state choice in PDMP systems</header><text display-inline="no-display-inline">Section 399O(h) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280g-3">42 U.S.C. 280g–3(h)</external-xref>) is amended by adding at the end the following:</text><quoted-block id="H4E48A459C3304D6CB4E3E879BF06664F" style="OLC"><paragraph id="HF9836028A2274D17BE766AD851B94D5E"><enum>(5)</enum><header>Promoting state choice</header><text>Nothing in this section shall be construed to authorize the Secretary to require States to use a specific vendor or a specific interoperability connection other than to align with nationally recognized, consensus-based open standards, such as in accordance with sections 3001 and 3004.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="H16E0CB23DC024C4988E5B90F2F926E8E"><enum>516.</enum><header>First responder training program</header><text display-inline="no-display-inline">Section 546 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290ee-1">42 U.S.C. 290ee–1</external-xref>) is amended—</text><paragraph id="H75DAA255A5DC4AA3B78AE0A6C85FCEA0"><enum>(1)</enum><text>in subsection (a), by striking <quote>tribes and tribal</quote> and inserting <quote>Tribes and Tribal</quote>;</text></paragraph><paragraph id="H5B447585C90B4BDCA0D54655544CE582"><enum>(2)</enum><text>in subsections (a), (c), and (d)—</text><subparagraph id="H4139EF6C8F574EE384E0BCB530D311B6"><enum>(A)</enum><text>by striking <quote>approved or cleared</quote> each place it appears and inserting <quote>approved, cleared, or otherwise legally marketed</quote>; and</text></subparagraph><subparagraph id="HE41A9977A01D43FA88EF491BF0503C0D"><enum>(B)</enum><text>by striking <quote>opioid</quote> each place it appears;</text></subparagraph></paragraph><paragraph id="H464E9F07F6284243928480FDA880AB04"><enum>(3)</enum><text>in subsection (f)—</text><subparagraph id="H2947B451E0934749856311629A20EE8F"><enum>(A)</enum><text>by striking <quote>approved or cleared</quote> each place it appears and inserting <quote>approved, cleared, or otherwise legally marketed</quote>;</text></subparagraph><subparagraph id="H0DC9710ED4F64BCDBBD6BAAC5B8E9AF7"><enum>(B)</enum><text>in paragraph (1), by striking <quote>opioid</quote>;</text></subparagraph><subparagraph id="H495D1834D08A4096AA13AE4F09528ED9"><enum>(C)</enum><text>in paragraph (2)—</text><clause id="H3E9015F63466449698DA4BEA2A21C99F"><enum>(i)</enum><text>by striking <quote>opioid and heroin</quote> and inserting <quote>opioid, heroin, and other drug</quote>; and</text></clause><clause id="HAA1210D1F01D43318A7ECFD2158C6C42"><enum>(ii)</enum><text>by striking <quote>opioid overdose</quote> and inserting <quote>overdose</quote>; and</text></clause></subparagraph><subparagraph id="HAD75D296B94E475DAA6330BC14D333E9"><enum>(D)</enum><text>in paragraph (3), by striking <quote>opioid and heroin</quote>; and</text></subparagraph></paragraph><paragraph id="H79B7EDE207F745F1823C70CD93C0C1E2"><enum>(4)</enum><text>in subsection (h), by striking <quote>$36,000,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$56,000,000 for each of fiscal years 2025 through 2029</quote>.</text></paragraph></section><section id="H7337B71406FC45CDBB864570D7C7E730"><enum>517.</enum><header>Donald J. Cohen National Child Traumatic Stress Initiative</header><subsection id="HAD976751F1B443C78649CA43DE42B4B8" commented="no"><enum>(a)</enum><header>Technical amendment</header><text display-inline="yes-display-inline">The second part G of title V of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290kk">42 U.S.C. 290kk et seq.</external-xref>), as added by section 144 of the Community Renewal Tax Relief Act (<external-xref legal-doc="public-law" parsable-cite="pl/106/554">Public Law 106–554</external-xref>), is amended—</text><paragraph id="HD02638A0B638470C9FE28A7FA6A27A7E" commented="no"><enum>(1)</enum><text>by redesignating such part as part J; and</text></paragraph><paragraph id="H70555FD592D44625B9E431044B514C9A" commented="no"><enum>(2)</enum><text>by redesignating sections 581 through 584 as sections 596 through 596C, respectively.</text></paragraph></subsection><subsection id="H4874165C4835465EA575CA6F9E5A9BE4"><enum>(b)</enum><header>In general</header><text display-inline="yes-display-inline">Section 582 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290hh-1">42 U.S.C. 290hh–1</external-xref>) is amended—</text><paragraph id="H3A682AE325BB479B88EEC60A7E8974F3"><enum>(1)</enum><text>in the section heading, by striking <quote><header-in-text level="section" style="OLC">VIOLENCE RELATED STRESS</header-in-text></quote> and inserting <quote><header-in-text level="section" style="OLC">TRAUMATIC EVENTS</header-in-text></quote>;</text></paragraph><paragraph id="H0424AF04F8A24674B0A5ACDF54764E60"><enum>(2)</enum><text>in subsection (a)—</text><subparagraph id="H5548EC31D8F84318979C976D40610989"><enum>(A)</enum><text>in the matter preceding paragraph (1), by striking <quote>tribes and tribal</quote> and inserting <quote>Tribes and Tribal</quote>; and</text></subparagraph><subparagraph id="H5B3AB9D00EB841BAB1923D4E15AC8199"><enum>(B)</enum><text>in paragraph (2), by inserting <quote>and dissemination</quote> after <quote>the development</quote>;</text></subparagraph></paragraph><paragraph id="HA6EBC02C2DF4457CA76B3363C26B3D61"><enum>(3)</enum><text>in subsection (b), by inserting <quote>and dissemination</quote> after <quote>the development</quote>;</text></paragraph><paragraph id="HFB9276298FB84F46B8102B1CB57E1E8E"><enum>(4)</enum><text>in subsection (d)—</text><subparagraph id="H98776CF919EF4F04B5CB6F53FEA9CC46"><enum>(A)</enum><text>by striking <quote>The NCTSI</quote> and inserting the following:</text><quoted-block id="HA015BA84F2AC46119670E0BF001A1E4B" style="OLC"><paragraph id="H83AE8BCFE87B41AAAFF654369AAC249A"><enum>(1)</enum><header>Coordinating center</header><text>The NCTSI</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph id="HDF71153F7408469A819819A68EFB200B"><enum>(B)</enum><text>by adding at the end the following:</text><quoted-block id="H4AB7238740BD45E6A6B0340F262651C9" style="OLC"><paragraph id="H705DF307BED14B769A82C17004BCA180"><enum>(2)</enum><header>N<enum-in-header>CTSI</enum-in-header> grantees</header><text>In carrying out subsection (a)(2), NCTSI grantees shall develop trainings and other resources, as applicable and appropriate, to support implementation of the evidence-based practices developed and disseminated under such subsection.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="HA6A6041905BD425CBA13A838384DE6BA"><enum>(5)</enum><text>in subsection (e)—</text><subparagraph id="H3DFB0C41E7114CB2B6C03DD5690F375A"><enum>(A)</enum><text>by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively, and adjusting the margins accordingly;</text></subparagraph><subparagraph id="H85961E12812A4FBF8E1169CD67D5EE4F"><enum>(B)</enum><text>in subparagraph (A), as so redesignated, by inserting <quote>and implementation</quote> after <quote>the dissemination</quote>;</text></subparagraph><subparagraph id="H59A6C4E7A8C44911BF4917C0954259E2"><enum>(C)</enum><text>by striking <quote>The NCTSI</quote> and inserting the following:</text><quoted-block id="HD0500283A23A4A26868FC30A4EB611EC" style="OLC"><paragraph id="H017B9604473043B897CF0BCBDDB63A22"><enum>(1)</enum><header>Coordinating center</header><text>The NCTSI</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph id="H3A13F1F7BC994C35BF760C1CCDF27513"><enum>(D)</enum><text>by adding at the end the following:</text><quoted-block id="H498DFEFF564A4AF79BECECADB34E5E98" style="OLC"><paragraph id="H558DF27DF143459CA594D915D64E2B4E"><enum>(2)</enum><header>N<enum-in-header>CTSI</enum-in-header> grantees</header><text>NCTSI grantees shall, as appropriate, collaborate with other such grantees, the NCTSI coordinating center, and the Secretary in carrying out subsections (a)(2) and (d)(2).</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H98E90838A5B24361AC8DDFC2A3FF6BBE"><enum>(6)</enum><text>by amending subsection (h) to read as follows:</text><quoted-block id="H8E6EF73DB60B49B898A95A367F195082" style="OLC"><subsection id="H31C7A8820E0F4CC7BD12F5851320A7E3"><enum>(h)</enum><header>Application and evaluation</header><text>To be eligible to receive a grant, contract, or cooperative agreement under subsection (a), a public or nonprofit private entity or an Indian Tribe or Tribal organization shall submit to the Secretary an application at such time, in such manner, and containing such information and assurances as the Secretary may require, including—</text><paragraph id="HD6C27E1AC98648D4BEA3A6524B06B903"><enum>(1)</enum><text>a plan for the evaluation of the activities funded under the grant, contract, or agreement, including both process and outcomes evaluation, and the submission of an evaluation at the end of the project period; and</text></paragraph><paragraph id="H4C6C9909E9164A60909C58FCA2C32D79"><enum>(2)</enum><text>a description of how such entity, Indian Tribe, or Tribal organization will support efforts led by the Secretary or the NCTSI coordinating center, as applicable, to evaluate activities carried out under this section.</text></paragraph></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="H2AB76FB87D124A71B29E621610A57D9A"><enum>(7)</enum><text>by amending subsection (j) to read as follows:</text><quoted-block style="OLC" id="HBCAF76DD11B242408563E7BEF4BD7F79" display-inline="no-display-inline"><subsection id="H18E89FB481F54719AD453AC4FFCFAAEF"><enum>(j)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">There is authorized to be appropriated to carry out this section—</text><paragraph id="H735F2AF1C5BF4F69BDBF97016B88DB90"><enum>(1)</enum><text display-inline="yes-display-inline">$93,887,000 for fiscal year 2025;</text></paragraph><paragraph id="HD1179D3F4AC74B6FA5DE883BB3849448"><enum>(2)</enum><text>$95,000,000 for fiscal year 2026;</text></paragraph><paragraph id="H09C62BD571E949D0AA14EB530046B574"><enum>(3)</enum><text>$97,000,000 for fiscal year 2027;</text></paragraph><paragraph id="HD608065C939C43A8B865B2324B5F47ED"><enum>(4)</enum><text>$100,000,000 for fiscal year 2028; and</text></paragraph><paragraph id="HBB848CCA669142CF870F32A9842A7888"><enum>(5)</enum><text>$100,000,000 for fiscal year 2029.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section><section id="H5C574E6BFF504FAF8E029FF32066047A"><enum>518.</enum><header>Protecting suicide prevention lifeline from cybersecurity incidents</header><subsection id="H6986A7348252454296A32F434D2F5446"><enum>(a)</enum><header>National suicide prevention lifeline program</header><text>Section 520E–3(b) of the Public Health Service Act (42 U.S.C. 290bb–36c(b)) is amended—</text><paragraph id="HB911EEE1F51047BE8364CB0CEA1BF28D"><enum>(1)</enum><text>in paragraph (4), by striking <quote>and</quote> at the end;</text></paragraph><paragraph id="H03C418C37AFD4A50A7E7E6476AB39BFB"><enum>(2)</enum><text>in paragraph (5), by striking the period at the end and inserting <quote>; and</quote>; and</text></paragraph><paragraph id="H3FDBB35EDACA40909AFA7E00B12911EE"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block id="HDA08FDF1B95545B29249B6A3B207D266" style="OLC"><paragraph id="H95702FFAC7B541A69129C44D2573FE96"><enum>(6)</enum><text>taking such steps as may be necessary to ensure the suicide prevention hotline is protected from cybersecurity incidents and eliminates known cybersecurity vulnerabilities.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H785868B1CE284268BC2707F98742CCF8"><enum>(b)</enum><header>Reporting</header><text>Section 520E–3 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-36c">42 U.S.C. 290bb–36c</external-xref>) is amended—</text><paragraph id="H1479421AE97F4BFC8519D3E7EBC9F9FC"><enum>(1)</enum><text>by redesignating subsection (f) as subsection (g); and</text></paragraph><paragraph id="H166ECE4BFEAB4289AD0F68E443299904"><enum>(2)</enum><text>by inserting after subsection (e) the following:</text><quoted-block id="H67755AF3400A445DB75C4EFB91ECE29A" style="OLC"><subsection id="H3CFC1697ABC04EABA0FDC03ECFEB4267"><enum>(f)</enum><header>Cybersecurity reporting</header><paragraph id="H776410CE7B55488593923D57BA9278EC"><enum>(1)</enum><header>Notification</header><subparagraph id="HD0C092D0556C454691B907EF2417FF2D"><enum>(A)</enum><header>In general</header><text>The program’s network administrator receiving Federal funding pursuant to subsection (a) shall report to the Assistant Secretary, in a manner that protects personal privacy, consistent with applicable Federal and State privacy laws—</text><clause id="H190961B6B6754BF9A2D4AD83D73EB61E"><enum>(i)</enum><text>any identified cybersecurity vulnerabilities to the program within a reasonable amount of time after identification of such a vulnerability; and</text></clause><clause id="HA26374CF237343538A62DE1327EA7788"><enum>(ii)</enum><text>any identified cybersecurity incidents to the program within a reasonable amount of time after identification of such incident.</text></clause></subparagraph><subparagraph id="H06663331824140BAA3A46DBEE29C832D"><enum>(B)</enum><header>Local and regional crisis centers</header><text>Local and regional crisis centers participating in the program shall report to the program’s network administrator identified under subparagraph (A), in a manner that protects personal privacy, consistent with applicable Federal and State privacy laws—</text><clause id="H3CF9F18B21C14FD090BCFA5DC35CC71C"><enum>(i)</enum><text>any identified cybersecurity vulnerabilities to the program within a reasonable amount of time after identification of such vulnerability; and</text></clause><clause id="H9D158D5DDF8F402C91DCA44FCA3388A3"><enum>(ii)</enum><text>any identified cybersecurity incidents to the program within a reasonable amount of time after identification of such incident.</text></clause></subparagraph></paragraph><paragraph id="H3848E91E64554E9BB046107FEA965A0B"><enum>(2)</enum><header>Notification</header><text>If the program’s network administrator receiving funding pursuant to subsection (a) discovers, or is informed by a local or regional crisis center pursuant to paragraph (1)(B) of, a cybersecurity vulnerability or incident, within a reasonable amount of time after such discovery or receipt of information, such entity shall report the vulnerability or incident to the Assistant Secretary.</text></paragraph><paragraph id="H63E0631E86C344109D61B5B5A878CE6A"><enum>(3)</enum><header>Clarification</header><subparagraph id="HED238A543D2A425BB92FD1C281095DBD"><enum>(A)</enum><header>Oversight</header><clause id="H4ABD5447348C4E00B9CF96F9E2C3A28F"><enum>(i)</enum><header>Local and regional crisis centers</header><text>Except as provided in clause (ii), local and regional crisis centers participating in the program shall oversee all technology each center employs in the provision of services as a participant in the program.</text></clause><clause id="H7FF9527389C341158176D11F6A7D37A2"><enum>(ii)</enum><header>Network administrator</header><text>The program’s network administrator receiving Federal funding pursuant to subsection (a) shall oversee the technology each crisis center employs in the provision of services as a participant in the program if such oversight responsibilities are established in the applicable network participation agreement.</text></clause></subparagraph><subparagraph id="H45C66BB1456B4A219BAED7D0F6FF46CC"><enum>(B)</enum><header>Supplement, not supplant</header><text>The cybersecurity incident reporting requirements under this subsection shall supplement, and not supplant, cybersecurity incident reporting requirements under other provisions of applicable Federal law that are in effect on the date of the enactment of the <short-title>SUPPORT for Patients and Communities Reauthorization Act of 2025</short-title>.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H37D2E5E4D404448A9148E3FAE53142F1"><enum>(c)</enum><header>Study</header><text>Not later than 180 days after the date of the enactment of this Act, the Comptroller General of the United States shall—</text><paragraph id="HF34FDC0DCF384093BE76043D1B85C418"><enum>(1)</enum><text>conduct and complete a study that evaluates cybersecurity risks and vulnerabilities associated with the 9–8–8 National Suicide Prevention Lifeline; and</text></paragraph><paragraph id="HBBB2A921C14642FF8219C766979B77BE"><enum>(2)</enum><text>submit a report on the findings of such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.</text></paragraph></subsection></section><section id="H7D1165B9667946E896F408C9AE969D3A"><enum>519.</enum><header>Bruce’s law</header><subsection id="HC8104F7E598A4DD4947E9D4FD439F9D4"><enum>(a)</enum><header>Youth prevention and recovery</header><text>Section 7102(c) of the SUPPORT for Patients and Communities Act (42 U.S.C. 290bb–7a(c)) is amended—</text><paragraph id="H2FFE68B8FF3C4C7EB0D3D8AB66C65AE3"><enum>(1)</enum><text>in paragraph (3)(A)(i), by inserting <quote>, which may include strategies to increase education and awareness of the potency and dangers of synthetic opioids (including drugs contaminated with fentanyl) and, as appropriate, other emerging drug use or misuse issues</quote> before the semicolon; and</text></paragraph><paragraph id="H9DB34390F48D48B3B597D1F73A0DAFBF"><enum>(2)</enum><text>in paragraph (4)(A), by inserting <quote>and strategies to increase education and awareness of the potency and dangers of synthetic opioids (including drugs contaminated with fentanyl) and, as appropriate, emerging drug use or misuse issues</quote> before the semicolon.</text></paragraph></subsection><subsection id="HF150B6402C504CBABEC85C785377F4CC"><enum>(b)</enum><header>Interdepartmental substance use disorders coordinating committee</header><text>Section 7022 of the SUPPORT for Patients and Communities Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290aa">42 U.S.C. 290aa</external-xref> note) is amended—</text><paragraph id="H1B76782B511F4278BCDA63345B7065C4"><enum>(1)</enum><text>by striking subsection (g) and inserting the following:</text><quoted-block id="H0CF3DD3A3401492A9D11001EC757349C" style="OLC"><subsection id="HBCA2C064BF604056B12D37115F769CFB"><enum>(g)</enum><header>Working groups</header><paragraph id="HD395E2CC5E7A442396811A8209142993"><enum>(1)</enum><header>In general</header><text>The Committee may establish working groups for purposes of carrying out the duties described in subsection (e). Any such working group shall be composed of members of the Committee (or the designees of such members) and may hold such meetings as are necessary to carry out the duties delegated to the working group.</text></paragraph><paragraph id="H3F1A196D3E5D409BB8751159FEA146BA"><enum>(2)</enum><header>Additional federal interagency work group on fentanyl contamination of illegal drugs</header><subparagraph id="HB6996652B4BE44BFA8A914736EBB1A1C"><enum>(A)</enum><header>Establishment</header><text>The Secretary, acting through the Committee, shall establish a Federal Interagency Work Group on Fentanyl Contamination of Illegal Drugs (referred to in this paragraph as the <quote>Work Group</quote>) consisting of representatives from relevant Federal departments and agencies on the Committee.</text></subparagraph><subparagraph id="H726FA899785B4113996630332C9689F3"><enum>(B)</enum><header>Consultation</header><text>The Work Group shall consult with relevant stakeholders and subject matter experts, including—</text><clause id="HF4106C8CF1F749F9BC91D3538798E186"><enum>(i)</enum><text>State, Tribal, and local subject matter experts in reducing, preventing, and responding to drug overdose caused by fentanyl contamination of illicit drugs; and</text></clause><clause id="H88D498F1AA7B4B4FAE820059530394B5"><enum>(ii)</enum><text>family members of both adults and youth who have overdosed by fentanyl-contaminated illicit drugs.</text></clause></subparagraph><subparagraph id="H79FEB7FCD4D94E7EBFB96222D0DE6E54"><enum>(C)</enum><header>Duties</header><text>The Work Group shall—</text><clause id="H2AF0923B793B463E9809B963F744F059"><enum>(i)</enum><text>examine Federal efforts to reduce and prevent drug overdose by fentanyl-contaminated illicit drugs;</text></clause><clause id="HC41DC7B219344103918D30F96E2AABD9"><enum>(ii)</enum><text>identify strategies to improve State, Tribal, and local responses to overdose by fentanyl-contaminated illicit drugs;</text></clause><clause id="HD4F31D1ED28340DAA64A86717C3F2715"><enum>(iii)</enum><text>coordinate with the Secretary, as appropriate, in carrying out activities to raise public awareness of synthetic opioids and other emerging drug use and misuse issues;</text></clause><clause id="HF0BD612980564D629633A92F6B183656"><enum>(iv)</enum><text>make recommendations to Congress for improving Federal programs, including with respect to the coordination of efforts across such programs; and</text></clause><clause id="H661984D1E0F24854A769EC9FE55A1296"><enum>(v)</enum><text>make recommendations for educating youth on the potency and dangers of drugs contaminated by fentanyl.</text></clause></subparagraph><subparagraph id="HBB89AD34567849A7AD535FF62560661B"><enum>(D)</enum><header>Annual report to secretary</header><text>The Work Group shall annually prepare and submit to the Secretary, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce and the Committee on Education and the Workforce of the House of Representatives, a report on the activities carried out by the Work Group under subparagraph (C), including recommendations to reduce and prevent drug overdose by fentanyl contamination of illegal drugs, in all populations, and specifically among youth at risk for substance misuse.</text></subparagraph></paragraph></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="HFF346C8CB96A41FC8934FB9CECD018A0"><enum>(2)</enum><text>by striking subsection (i) and inserting the following:</text><quoted-block id="HFDFFFC582D99416C8EBEE1F3230318DB" style="OLC"><clause id="H571EF7DA090B41E6B73B7B5BAA0A3927"><enum>(i)</enum><header>Sunset</header><text>The Committee shall terminate on September 30, 2029.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section><section id="H9A2D84E2981B481A821EE2CD5F2B238C"><enum>520.</enum><header>Guidance on at-home drug disposal systems</header><subsection id="H201AD8E8EA6C47FEADFC5DF551B55265"><enum>(a)</enum><header>In general</header><text>Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, shall publish guidance to facilitate the use of at-home safe disposal systems for applicable drugs.</text></subsection><subsection id="HDF0016670C9648D6B285213957EDD26E"><enum>(b)</enum><header>Contents</header><text>The guidance under subsection (a) shall include—</text><paragraph id="HA50DE1A5F85C4AE88E029EEFC0F660CC"><enum>(1)</enum><text>recommended standards for effective at-home drug disposal systems to meet applicable requirements enforced by the Food and Drug Administration;</text></paragraph><paragraph id="H7913E788F5C040C082AE2A482426FC51"><enum>(2)</enum><text>recommended information to include as instructions for use to disseminate with at-home drug disposal systems;</text></paragraph><paragraph id="H782B4D8D5E2C4099B029A7945E5DA5F9"><enum>(3)</enum><text>best practices and educational tools to support the use of an at-home drug disposal system, as appropriate; and</text></paragraph><paragraph id="HCFA6D67DD960468390D292D4D8DABF91"><enum>(4)</enum><text>recommended use of licensed health providers for the dissemination of education, instruction, and at-home drug disposal systems, as appropriate.</text></paragraph></subsection></section><section id="H880A624F71A344BDBAA3D77868F64B40"><enum>521.</enum><header>Assessment of opioid drugs and actions</header><subsection id="H7547BAD1613547E08CCCEAE5929F5872"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) shall publish on the website of the Food and Drug Administration (referred to in this section as the <quote>FDA</quote>) a report that outlines a plan for assessing opioid analgesic drugs that are approved under section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) that addresses the public health effects of such opioid analgesic drugs as part of the benefit-risk assessment and the activities of the FDA that relate to facilitating the development of nonaddictive medical products intended to treat pain or addiction. Such report shall include—</text><paragraph id="HB0DBEE469024478E9C2AB5D26E0DB387"><enum>(1)</enum><text>an update on the actions taken by the FDA to consider the effectiveness, safety, benefit-risk profile, and use of approved opioid analgesic drugs;</text></paragraph><paragraph id="H2DB216D115324D07A55FBC3148396D35"><enum>(2)</enum><text>a timeline for an assessment of the potential need, as appropriate, for labeling changes, revised or additional postmarketing requirements, enforcement actions, or withdrawals for opioid analgesic drugs;</text></paragraph><paragraph id="H389898B83A1847F482A85B1FB82A3584"><enum>(3)</enum><text>an overview of the steps that the FDA has taken to support the development and approval of nonaddictive medical products intended to treat pain or addiction, and actions planned to further support the development and approval of such products; and</text></paragraph><paragraph id="H86CFE29C0B344B70B5AAB966C5746DB6"><enum>(4)</enum><text>an overview of the consideration by the FDA of clinical trial methodologies for analgesic drugs, including the enriched enrollment randomized withdrawal methodology, and the benefits and drawbacks associated with different trial methodologies for such drugs, incorporating any public input received under subsection (b).</text></paragraph></subsection><subsection id="H1223716AF9CF42FC86FB7665F66E2C87"><enum>(b)</enum><header>Public input</header><text display-inline="yes-display-inline">In carrying out subsection (a), the Secretary shall provide an opportunity for public input concerning the regulation by the FDA of opioid analgesic drugs, including scientific evidence that relates to conditions of use, safety, or benefit-risk assessment (including consideration of the public health effects) of such opioid analgesic drugs.</text></subsection></section><section id="HFB0530157BD3490A9D850314C2660789"><enum>522.</enum><header>Grant program for State and Tribal response to opioid use disorders</header><text display-inline="no-display-inline">The activities carried out pursuant to section 1003(b)(4)(A) of the 21st Century Cures Act (42 U.S.C. 290ee–3a(b)(4)(A)) may include facilitating access to products used to prevent overdose deaths by detecting the presence of one or more substances, such as fentanyl and xylazine test strips, to the extent the purchase and possession of such products is consistent with Federal and State law.</text></section></subtitle><subtitle id="H8905C906D0B94DD0A4062EBC0755BE30"><enum>B</enum><header>Treatment</header><section id="HBF43094F360042149DF4D7BDA5F3C9BB"><enum>531.</enum><header>Residential treatment program for pregnant and postpartum women</header><text display-inline="no-display-inline">Section 508 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-1">42 U.S.C. 290bb–1</external-xref>) is amended—</text><paragraph id="H7461DF65BCED4AC0B0D734A8BB8F0513"><enum>(1)</enum><text>in subsection (d)(11)(C), by striking <quote>providing health services</quote> and inserting <quote>providing health care services</quote>;</text></paragraph><paragraph id="HE71CE2AA65A947F1ACCFB445CB871443"><enum>(2)</enum><text>in subsection (g)—</text><subparagraph id="H2256AAEA1C80483595ECB2BFD29DB693"><enum>(A)</enum><text>by inserting <quote>a plan describing</quote> after <quote>will provide</quote>; and</text></subparagraph><subparagraph id="H10F4D56C591D421F954A64E9F1EE3088"><enum>(B)</enum><text>by adding at the end the following: <quote>Such plan may include a description of how such applicant will target outreach to women disproportionately impacted by maternal substance use disorder.</quote>; and</text></subparagraph></paragraph><paragraph id="H2A065735583C44CEB8D53DA636D49D89"><enum>(3)</enum><text>in subsection (s), by striking <quote>$29,931,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$38,931,000 for each of fiscal years 2025 through 2029</quote>.</text></paragraph></section><section id="HECA6B841C68B43CF8C0E4ED531EB3961"><enum>532.</enum><header>Improving access to addiction medicine providers</header><text display-inline="no-display-inline">Section 597 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290ll">42 U.S.C. 290ll</external-xref>) is amended—</text><paragraph id="H3F2EB7D39F854E48BF4E4A9D2F9D0DA1"><enum>(1)</enum><text>in subsection (a)(1), by inserting <quote>diagnosis,</quote> after <quote>related to</quote>; and</text></paragraph><paragraph id="H67BF568CA49D43568AE425123FC23B19"><enum>(2)</enum><text>in subsection (b), by inserting <quote>addiction medicine,</quote> after <quote>psychiatry,</quote>.</text></paragraph></section><section id="HC17D20C3CC694785AAAED23BFE781DDB" commented="no"><enum>533.</enum><header>Mental and behavioral health education and training grants</header><text display-inline="no-display-inline">Section 756(f) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/294e-1">42 U.S.C. 294e–1(f)</external-xref>) is amended by striking <quote>fiscal years 2023 through 2027</quote> and inserting <quote>fiscal years 2025 through 2029</quote>.</text></section><section id="H01452F982E5E4BDD96F73E4B0906F489"><enum>534.</enum><header>Loan repayment program for substance use disorder treatment workforce</header><text display-inline="no-display-inline">Section 781(j) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/295h">42 U.S.C. 295h(j)</external-xref>) is amended by striking <quote>$25,000,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$40,000,000 for each of fiscal years 2025 through 2029</quote>.</text></section><section id="HD4780649C3C24902A18B8E0390C57E13" commented="no"><enum>535.</enum><header>Development and dissemination of model training programs for substance use disorder patient records</header><text display-inline="no-display-inline">Section 7053 of the SUPPORT for Patients and Communities Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290dd-2">42 U.S.C. 290dd–2</external-xref> note) is amended by striking subsection (e).</text></section><section id="HD7867945C0774D33962295CAFAB949D6"><enum>536.</enum><header>Task force on best practices for trauma-informed identification, referral, and support</header><text display-inline="no-display-inline">Section 7132 of the SUPPORT for Patients and Communities Act (<external-xref legal-doc="public-law" parsable-cite="pl/115/271">Public Law 115–271</external-xref>; 132 Stat. 4046) is amended—</text><paragraph id="H5B7C7AD144794B00AB9CA1F1E66BF6FC"><enum>(1)</enum><text>in subsection (b)(1)—</text><subparagraph id="H0C12DBC4D243412AA20EB18F41F2CD69"><enum>(A)</enum><text>by redesignating subparagraph (CC) as subparagraph (DD); and</text></subparagraph><subparagraph id="HFE709241A6714D4D9F6ADF0ADDF41B7A"><enum>(B)</enum><text>by inserting after subparagraph (BB) the following:</text><quoted-block id="H782A2188C14F451D93695D083301699D" style="OLC"><subparagraph id="H0FB0C34859DB4DDEB7E808FEBC47F24D"><enum>(CC)</enum><text>The Administration for Community Living.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H9A6279BD48034B3CB85F12576B8F74EB"><enum>(2)</enum><text>in subsection (d)(1), in the matter preceding subparagraph (A), by inserting <quote>, developmental disability service providers</quote> before <quote>, individuals who are</quote>; and</text></paragraph><paragraph id="H657A598BDE6147168AC673534FC787C6"><enum>(3)</enum><text>in subsection (i), by striking <quote>2023</quote> and inserting <quote>2029</quote>.</text></paragraph></section><section id="H489613803AC9479C9533D463A0A0F8CF" commented="no"><enum>537.</enum><header>Grants to enhance access to substance use disorder treatment</header><text display-inline="no-display-inline">Section 3203 of the SUPPORT for Patients and Communities Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823</external-xref> note) is amended—</text><paragraph id="HE92070C1536D43A6990BD0B477815A5E" commented="no"><enum>(1)</enum><text>by striking subsection (b); and</text></paragraph><paragraph id="H195BE90DF81B4BE2A32743A790154D7E" commented="no"><enum>(2)</enum><text>by striking <quote><header-in-text level="subsection" style="OLC"><enum-in-header>(a) </enum-in-header>In general</header-in-text>.—The Secretary</quote> and inserting the following: <quote>The Secretary</quote>.</text></paragraph></section><section id="HE3173023824B4030B651C945BC1E8EE1" commented="no"><enum>538.</enum><header>State guidance related to individuals with serious mental illness and children with serious emotional disturbance</header><subsection id="H371A8B5310DC400B85A88A83BBAD6F02" commented="no"><enum>(a)</enum><header>Review of use of certain funding</header><text>Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>), acting through the Assistant Secretary for Mental Health and Substance Use, shall conduct a review of State use of funds made available under the Community Mental Health Services Block Grant program under subpart I of part B of title XIX of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300x">42 U.S.C. 300x et seq.</external-xref>) (referred to in this section as the <quote>block grant program</quote>) for first episode psychosis activities. Such review shall consider the following:</text><paragraph id="H679062A0EFCD471BB51E0D5D16FC84CE" commented="no"><enum>(1)</enum><text>How States use funds for evidence-based treatments and services according to the standard of care for individuals with early serious mental illness and children with a serious emotional disturbance.</text></paragraph><paragraph id="H38B4A52BFE5F4EB3BB9891D58029D793" commented="no"><enum>(2)</enum><text>The percentages of the State funding under the block grant program expended on early serious mental illness and first episode psychosis, and the number of individuals served under such funds.</text></paragraph></subsection><subsection id="HB1C1204FC1D2426B96240C673AC24CF2" commented="no"><enum>(b)</enum><header>Report and guidance</header><paragraph id="H8E43A920D9D24595AB2D86B99449275E" commented="no"><enum>(1)</enum><header>Report</header><text>Not later than 180 days after the completion of the review under subsection (a), the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report describing—</text><subparagraph id="HB30E90E97D05448E97D941CA3938C5DD" commented="no"><enum>(A)</enum><text>the findings of the review under subsection (a); and</text></subparagraph><subparagraph id="HD66E5EC8289B479A8AB6A1ED3DAAADFD" commented="no"><enum>(B)</enum><text>any recommendations for changes to the block grant program that would facilitate improved outcomes for individuals with serious mental illness and children with serious emotional disturbance.</text></subparagraph></paragraph><paragraph id="HC8C11F2631AE47548908F2EE708F2740" commented="no"><enum>(2)</enum><header>Guidance</header><text>Not later than 1 year after the date on which the report is submitted under paragraph (1), the Secretary shall update the guidance provided to States under the block grant program on coordinated specialty care and other evidence-based mental health care services for individuals with serious mental illness and children with a serious emotional disturbance, based on the findings and recommendations of such report.</text></paragraph></subsection></section><section id="HC461A035878C438B922DB396F1875257"><enum>539.</enum><header>Reviewing the scheduling of approved products containing a combination of buprenorphine and naloxone</header><subsection id="HE788C799901E407E97CACBB2CFED3356"><enum>(a)</enum><header>Secretary of hhs</header><text>The Secretary of Health and Human Services shall, consistent with the requirements and procedures set forth in sections 201 and 202 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/811">21 U.S.C. 811</external-xref>, 812)—</text><paragraph id="H7142FB1544F043E7A998ABC748080D57"><enum>(1)</enum><text>review the relevant data pertaining to the scheduling of products containing a combination of buprenorphine and naloxone that have been approved under section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>); and</text></paragraph><paragraph id="H6EC4BFFCB03F4A038A9B2F7DC6745DFE"><enum>(2)</enum><text>if appropriate, request that the Attorney General initiate rulemaking proceedings to revise the schedules accordingly with respect to such products.</text></paragraph></subsection><subsection id="HD86990D07B1D4B139B2BEBB104D99EF9"><enum>(b)</enum><header>Attorney general</header><text>The Attorney General shall review any request made by the Secretary of Health and Human Services under subsection (a)(2) and determine whether to initiate proceedings to revise the schedules in accordance with the criteria set forth in sections 201 and 202 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/811">21 U.S.C. 811</external-xref>, 812).</text></subsection></section></subtitle><subtitle id="HE8CEF0550F284E96B0F35DACE6128BFC"><enum>C</enum><header>Recovery</header><section id="HF04738CE0D854C4998EFD578ACB011D5"><enum>541.</enum><header>Building communities of recovery</header><text display-inline="no-display-inline">Section 547(f) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290ee-2">42 U.S.C. 290ee–2(f)</external-xref>) is amended by striking <quote>$5,000,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$16,000,000 for each of fiscal years 2025 through 2029</quote>.</text></section><section id="H8160987F3D404B1B8AACC78D1B9B65C5"><enum>542.</enum><header>Peer support technical assistance center</header><text display-inline="no-display-inline">Section 547A of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290ee-2a">42 U.S.C. 290ee–2a</external-xref>) is amended—</text><paragraph id="HF89F0464B3ED421D8AE9A6BFD4345904"><enum>(1)</enum><text>in subsection (b)(4), by striking <quote>building; and</quote> and inserting the following: </text><quoted-block id="H02FD699A18C84901B4E9B5789DD5DA27" style="OLC" display-inline="yes-display-inline"><text>building, such as—</text><subparagraph id="H182EEC5E39B642D1A9EB8D649FB4FA56"><enum>(A)</enum><text>professional development of peer support specialists; and</text></subparagraph><subparagraph id="H60983C78D863441CBA7CCB1AEDB9EFE7"><enum>(B)</enum><text>making recovery support services available in nonclinical settings; and</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></paragraph><paragraph id="HFD5CBDCFEAC74EE3AA0886AC2B877531"><enum>(2)</enum><text>by redesignating subsections (d) and (e) as subsections (e) and (f), respectively;</text></paragraph><paragraph id="HB68C1FC9E02040FDA32885B1E7A19512"><enum>(3)</enum><text>by inserting after subsection (c) the following:</text><quoted-block id="HFB171C69EBD841BFAD92B04AA97045E9" style="OLC"><subsection id="H5907278A3EC04F77AE53D125399131DB"><enum>(d)</enum><header>Regional centers</header><paragraph id="HAE5D2EEBFD134F3ABAFEFE3E26A03F48"><enum>(1)</enum><header>In general</header><text>The Secretary may establish one regional technical assistance center (referred to in this subsection as the <quote>Regional Center</quote>), with existing resources, to assist the Center in carrying out activities described in subsection (b) within the geographic region of such Regional Center in a manner that is tailored to the needs of such region.</text></paragraph><paragraph id="HE8A7BDFA1F1643C8B60D0E480E4914AE"><enum>(2)</enum><header>Evaluation</header><text>Not later than 4 years after the date of enactment of the <short-title>SUPPORT for Patients and Communities Reauthorization Act of 2024</short-title>, the Secretary shall evaluate the activities of the Regional Center 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 on the findings of such evaluation, including—</text><subparagraph id="HE4B32253E91648D6B245AA339644CD07"><enum>(A)</enum><text>a description of the distinct roles and responsibilities of the Regional Center and the Center;</text></subparagraph><subparagraph id="H6F66C9BFB8B04E2F868226BD2063E2EC"><enum>(B)</enum><text>available information relating to the outcomes of the Regional Center under this subsection, such as any impact on the operations and efficiency of the Center relating to requests for technical assistance and support within the region of such Regional Center;</text></subparagraph><subparagraph id="HFF16F7427F924548ACA5BE12E3DB0F16"><enum>(C)</enum><text>a description of any gaps or areas of duplication relating to the activities of the Regional Center and the Center within such region; and</text></subparagraph><subparagraph id="HE707FB8AB19548678272C93C20952FA9"><enum>(D)</enum><text>recommendations relating to the modification, expansion, or termination of the Regional Center under this subsection.</text></subparagraph></paragraph><paragraph id="H3C051B63DE504D52AC872FA0C7E0BEA9"><enum>(3)</enum><header>Termination</header><text>This subsection shall terminate on September 30, 2029.</text></paragraph></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="HAA4C1A03DC25406783454E2FEDF0D35C"><enum>(4)</enum><text>in subsection (f), as so redesignated, by striking <quote>$1,000,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$2,000,000 for each of fiscal years 2025 through 2029</quote>.</text></paragraph></section><section id="H6DFD966BDD1B4EB3812B51D6ED508EB6"><enum>543.</enum><header>Comprehensive opioid recovery centers</header><text display-inline="no-display-inline">Section 552 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290ee-7">42 U.S.C. 290ee–7</external-xref>) is amended—</text><paragraph id="HCFB24594096E4E6BB0D2D3092551DAAD"><enum>(1)</enum><text>in subsection (d)(2)—</text><subparagraph id="HA898AB99A4BE484F8473D3F6D0EF9A28"><enum>(A)</enum><text>in the matter preceding subparagraph (A), by striking <quote>and in such manner</quote> and inserting <quote>, in such manner, and containing such information and assurances, including relevant documentation,</quote>; and</text></subparagraph><subparagraph id="HD086B2043E1C4C2A8143B55F535F417E"><enum>(B)</enum><text>in subparagraph (A), by striking <quote>is capable of coordinating with other entities to carry out</quote> and inserting <quote>has the demonstrated capability to carry out, through referral or contractual arrangements</quote>;</text></subparagraph></paragraph><paragraph id="H6B6795B267914722A08DEC63D1EE94F4"><enum>(2)</enum><text>in subsection (h)—</text><subparagraph id="H4A85465F213C40F3A9C65760E4DDD6EF"><enum>(A)</enum><text>by redesignating paragraphs (1) through (4) as subparagraphs (A) through (D), respectively, and adjusting the margins accordingly;</text></subparagraph><subparagraph id="H5E0C7DF65AC34EC793B0DF3626CCD73E"><enum>(B)</enum><text>by striking <quote>With respect to</quote> and inserting the following:</text><quoted-block id="H92951D9927724E9E8B1E473C7446E8D6" style="OLC"><paragraph id="H093B06BF2D974A5296F60CCCACFAA28C"><enum>(1)</enum><header>In general</header><text>With respect to</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph id="H44C379B116CE4A67B810A4AB979B6FB7"><enum>(C)</enum><text>by adding at the end the following:</text><quoted-block id="H768B0E900DB947D08017B60236517150" style="OLC"><paragraph id="HDACEFDE346844C5E83957B6C4FC90DDB"><enum>(2)</enum><header>Additional reporting for certain eligible entities</header><text>An entity carrying out activities described in subsection (g) through referral or contractual arrangements shall include in the submissions required under paragraph (1) information related to the status of such referrals or contractual arrangements, including an assessment of whether such referrals or contractual arrangements are supporting the ability of such entity to carry out such activities.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="HC729FB03F148463AAEE9596DE85E5D62"><enum>(3)</enum><text>in subsection (j), by striking <quote>2019 through 2023</quote> and inserting <quote>2025 through 2029</quote>.</text></paragraph></section><section id="HDAC3096101B54A1389F8314BD7F210E7"><enum>544.</enum><header>Youth prevention and recovery</header><text display-inline="no-display-inline">Section 7102(c) of the SUPPORT for Patients and Communities Act (42 U.S.C. 290bb–7a(c)) (as amended by section 110(a)) is amended—</text><paragraph id="H816B2B02E0E546E090FB0B10787F8ECA"><enum>(1)</enum><text>in paragraph (2)—</text><subparagraph id="H1F0DA3BA906C453885A4772F1D3D4160"><enum>(A)</enum><text>in subparagraph (A)—</text><clause id="HC0FC43ED1A4F45DA8E1106CAD9E521C9"><enum>(i)</enum><text>in clause (i)—</text><subclause id="H0D68ED40ECC74B02A448CA121F533729"><enum>(I)</enum><text>by inserting <quote>, or a consortium of local educational agencies,</quote> after <quote>a local educational agency</quote>; and</text></subclause><subclause id="H96B344B456474A41A02CA059BBE01732"><enum>(II)</enum><text>by striking <quote>high schools</quote> and inserting <quote>secondary schools</quote>; and</text></subclause></clause><clause id="H7D545323A06C4DC7835B0E3D7216E2B4"><enum>(ii)</enum><text>in clause (vi), by striking <quote>tribe, or tribal</quote> and inserting <quote>Tribe, or Tribal</quote>;</text></clause></subparagraph><subparagraph id="H3664B33F036F41FCA4BDC96FBD384CD5"><enum>(B)</enum><text>by amending subparagraph (E) to read as follows:</text><quoted-block id="H41908129DE4443B2ABB4B6ED86B03FD5" style="OLC"><subparagraph id="H88BA6341EFB54BCBAFE37DD5EC7E3282"><enum>(E)</enum><header>Indian tribe; tribal organization</header><text>The terms <term>Indian Tribe</term> and <term>Tribal organization</term> have the meanings given such terms in section 4 of the Indian Self-Determination and Education Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/25/5304">25 U.S.C. 5304</external-xref>).</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="H343A4237EB2B4C1282636E6594D3864D"><enum>(C)</enum><text>by redesignating subparagraph (K) as subparagraph (L); and</text></subparagraph><subparagraph id="HF211346F7FDE41C0898753B3A631F600"><enum>(D)</enum><text>by inserting after subparagraph (J) the following:</text><quoted-block id="H27362D0B52E84D11A72CCB8DA24D234D" style="OLC"><subparagraph id="HBEC2EFB6CC064DEBBC747E4F5893FBC7"><enum>(K)</enum><header>Secondary school</header><text>The term <term>secondary school</term> has the meaning given such term in section 8101 of the Elementary and Secondary Education Act of 1965 (<external-xref legal-doc="usc" parsable-cite="usc/20/7801">20 U.S.C. 7801</external-xref>).</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H088424D684E84CC3951F8F42671707C6"><enum>(2)</enum><text>in paragraph (3)(A), in the matter preceding clause (i)—</text><subparagraph id="H906F1C8108184E659AD1B4BFEF53F744"><enum>(A)</enum><text>by striking <quote>and abuse</quote>; and</text></subparagraph><subparagraph id="HFEEC9E6C09BA4F828C9D36822316ABA4"><enum>(B)</enum><text>by inserting <quote>at increased risk for substance misuse</quote> after <quote>specific populations</quote>;</text></subparagraph></paragraph><paragraph id="H1AF5AA532C654C02AAB666AF5FEC3389"><enum>(3)</enum><text>in paragraph (4)—</text><subparagraph id="HE57AAAB545BD4FE6A43A47C403C1AF7A"><enum>(A)</enum><text>in the matter preceding subparagraph (A), by striking <quote>Indian tribes</quote> and inserting <quote>Indian Tribes</quote>;</text></subparagraph><subparagraph id="H9595EF4F541B4BEC9C2EBA86AE935932"><enum>(B)</enum><text>in subparagraph (A), by striking <quote>and abuse</quote>; and</text></subparagraph><subparagraph id="HA82795B922BD4614AA116F1F97CAE073"><enum>(C)</enum><text>in subparagraph (B), by striking <quote>peer mentoring</quote> and inserting <quote>peer-to-peer support</quote>;</text></subparagraph></paragraph><paragraph id="H10D4188F53F14C3EB9F70AA1F8394D95"><enum>(4)</enum><text>in paragraph (5), by striking <quote>tribal</quote> and inserting <quote>Tribal</quote>;</text></paragraph><paragraph id="H023FB764C8C845ED841C004DA97DF66A"><enum>(5)</enum><text>in paragraph (6)(A)—</text><subparagraph id="HB45E995861524CB5BEF6B09C0BEF2116"><enum>(A)</enum><text>in clause (iv), by striking <quote>; and</quote> and inserting a semicolon; and</text></subparagraph><subparagraph id="H3A6B9AC0ECFB4219A720A62484C777A3"><enum>(B)</enum><text>by adding at the end the following:</text><quoted-block id="H15FD138F56A54126BFBAAA7483DD7170" style="OLC"><clause id="H3856CEC680934433931CD3B8D51D348F"><enum>(vi)</enum><text>a plan to sustain the activities carried out under the grant program, after the grant program has ended; and</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H1EAAEF9DE0E64D3A8EFF98B4FE0586D4"><enum>(6)</enum><text>in paragraph (8), by striking <quote>2022</quote> and inserting <quote>2027</quote>; and</text></paragraph><paragraph id="HE11BFB229DCC491CA7F3CF98A079FD8C" commented="no"><enum>(7)</enum><text>by amending paragraph (9) to read as follows:</text><quoted-block id="HDA801D0FD8314D86BF33F07DEDC1F483" style="OLC"><paragraph id="H0DF4FA1792BF4397B2CEF0A27DBD1304" commented="no"><enum>(9)</enum><header>Authorization of appropriations</header><text>To carry out this subsection, there are authorized to be appropriated—</text><subparagraph id="HBAF9FE883D8744988266BD6ECD1D72EA"><enum>(A)</enum><text display-inline="yes-display-inline">$10,000,000 for fiscal year 2025;</text></subparagraph><subparagraph id="H89BEE24C8A954E4EB340FAE41BBB9A39"><enum>(B)</enum><text>$12,000,000 for fiscal year 2026;</text></subparagraph><subparagraph id="HBA287C218215423CA4F81434FA53D747"><enum>(C)</enum><text>$13,000,000 for fiscal year 2027;</text></subparagraph><subparagraph id="H34C595E927F140F6B5B0D66AD060992B"><enum>(D)</enum><text>$14,000,000 for fiscal year 2028; and</text></subparagraph><subparagraph id="HD46C5ED401284BE7A5B0EAADDF959ED9"><enum>(E)</enum><text>$15,000,000 for fiscal year 2029.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="HE12B4F0E43D74E9B94AC8F927E1D52BB"><enum>545.</enum><header>CAREER Act</header><subsection id="H71913C2DED8B47E796858836C7A118AE"><enum>(a)</enum><header>In general</header><text>Section 7183 of the SUPPORT for Patients and Communities Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290ee-8">42 U.S.C. 290ee–8</external-xref>) is amended—</text><paragraph id="HE8F52249440B4448A76239C9A5B99F3F"><enum>(1)</enum><text>in the section heading, by inserting <quote><header-in-text level="section" style="OLC">; TREATMENT, RECOVERY, AND WORKFORCE SUPPORT GRANTS</header-in-text></quote> after <quote><header-in-text level="section" style="OLC">CAREER ACT</header-in-text></quote>;</text></paragraph><paragraph id="H21F15888445B4E2EACE69FA6806F6A4A"><enum>(2)</enum><text>in subsection (b), by inserting <quote>each</quote> before <quote>for a period</quote>;</text></paragraph><paragraph id="H206C1ED28C7F4DE4870E1A435A6E7153"><enum>(3)</enum><text>in subsection (c)—</text><subparagraph id="H7EDDEE4824AA4759B39DAFA82755EC6A"><enum>(A)</enum><text>in paragraph (1), by striking <quote>the rates described in paragraph (2)</quote> and inserting <quote>the average rates for calendar years 2018 through 2022 described in paragraph (2)</quote>; and</text></subparagraph><subparagraph id="HAB782868FD324F4EB8DB13658204E2DB"><enum>(B)</enum><text>by amending paragraph (2) to read as follows:</text><quoted-block id="H7D5B39FF8A9043369C64E9C20EA14E97" style="OLC"><paragraph id="H28AFC49CDEC9480893D008683CA2DBD5"><enum>(2)</enum><header>Rates</header><text>The rates described in this paragraph are the following:</text><subparagraph id="H43A094D9FEB04FD29261E3F607D5C5C1"><enum>(A)</enum><text>The highest age-adjusted average rates of drug overdose deaths for calendar years 2018 through 2022 based on data from the Centers for Disease Control and Prevention, including, if necessary, provisional data for calendar year 2022.</text></subparagraph><subparagraph id="HF775FDAA659E4DA5A307E9EAAA986A9A"><enum>(B)</enum><text>The highest average rates of unemployment for calendar years 2018 through 2022 based on data provided by the Bureau of Labor Statistics.</text></subparagraph><subparagraph id="H2C93852C994C4FD7B51A3B385026C646"><enum>(C)</enum><text>The lowest average labor force participation rates for calendar years 2018 through 2022 based on data provided by the Bureau of Labor Statistics.</text></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H46C5F3A128394DDAAC8319F890CF8616"><enum>(4)</enum><text>in subsection (g)—</text><subparagraph id="H1D04141CDA5341D4A2ECE1BCF706E9BA"><enum>(A)</enum><text>in each of paragraphs (1) and (3), by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and adjusting the margins accordingly;</text></subparagraph><subparagraph id="H0332169AFF1D4B5F8D3652E7BE837509"><enum>(B)</enum><text>by redesignating paragraphs (1) through (3) as subparagraphs (A) through (C), respectively, and adjusting the margins accordingly;</text></subparagraph><subparagraph id="H2CC9A862F9CD4202A7600CF824808DF5"><enum>(C)</enum><text>in the matter preceding subparagraph (A) (as so redesignated), by striking <quote>An entity</quote> and inserting the following:</text><quoted-block id="H466D11A6B520460FA497E9812A2422E2" style="OLC"><paragraph id="HB55E894066E142CFA6F99CA12EEAEEE3"><enum>(1)</enum><header>In general</header><text>An entity</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph id="HF23C7E4F55AD41F28A920D3C7332CB32"><enum>(D)</enum><text>by adding at the end the following:</text><quoted-block id="HC6AEC073665C402CBB558407F09C8BB1" style="OLC"><paragraph id="HACDA3947D85B4EEC85A938A1B3304DCF"><enum>(2)</enum><header>Transportation services</header><text>An entity receiving a grant under this section may use not more than 5 percent of the funds for providing transportation for individuals to participate in an activity supported by a grant under this section, which transportation shall be to or from a place of work or a place where the individual is receiving vocational education or job training services or receiving services directly linked to treatment of or recovery from a substance use disorder.</text></paragraph><paragraph id="H54923584545A4B18B723DBB31DB4CB62"><enum>(3)</enum><header>Limitation</header><text>The Secretary may not require an entity to, or give priority to an entity that plans to, use the funds of a grant under this section for activities that are not specified in this subsection.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H54FCA8F327D9429985C51354BF084F04"><enum>(5)</enum><text>in subsection (i)(2), by inserting <quote>, which shall include employment and earnings outcomes described in subclauses (I) and (III) of section 116(b)(2)(A)(i) of the Workforce Innovation and Opportunity Act (<external-xref legal-doc="usc" parsable-cite="usc/29/3141">29 U.S.C. 3141(b)(2)(A)(i)</external-xref>) with respect to the participation of such individuals with a substance use disorder in programs and activities funded by the grant under this section</quote> after <quote>subsection (g)</quote>;</text></paragraph><paragraph id="H546A36A7D87942E0A8B2EF403531C1F5"><enum>(6)</enum><text>in subsection (j)—</text><subparagraph id="H8202BC26EA074B9884BA52C4C9F4C8C0"><enum>(A)</enum><text>in paragraph (1), by inserting <quote>for grants awarded prior to the date of enactment of the <short-title>SUPPORT for Patients and Communities Reauthorization Act of 2025</short-title></quote> after <quote>grant period under this section</quote>; and</text></subparagraph><subparagraph id="H214EE5BD49594A9D92FB8140643CEDE3"><enum>(B)</enum><text>in paragraph (2)—</text><clause id="HF5468472708A40DCBDBCCDF9F5863AFB"><enum>(i)</enum><text>in the matter preceding subparagraph (A), by striking <quote>2 years after submitting the preliminary report required under paragraph (1)</quote> and inserting <quote>September 30, 2029</quote>; and</text></clause><clause id="H429D064158A14E3886BF869C4D24A4F9"><enum>(ii)</enum><text>in subparagraph (A), by striking <quote>(g)(3)</quote> and inserting <quote>(g)(1)(C)</quote>; and</text></clause></subparagraph></paragraph><paragraph id="HABCD00A3785948CA8B540F589C4F032F"><enum>(7)</enum><text>in subsection (k), by striking <quote>$5,000,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$12,000,000 for each of fiscal years 2025 through 2029</quote>.</text></paragraph></subsection><subsection id="H83BCC838428D4B7CA19A81091B543B2B" commented="no"><enum>(b)</enum><header>Reauthorization of the CAREER Act; Recovery Housing Pilot Program</header><paragraph id="H2F04374D9A574DFFA5D10E4F3127446E" commented="no"><enum>(1)</enum><header>In general</header><text>Section 8071 of the SUPPORT for Patients and Communities Act (<external-xref legal-doc="usc" parsable-cite="usc/42/5301">42 U.S.C. 5301</external-xref> note; <external-xref legal-doc="public-law" parsable-cite="pl/115/271">Public Law 115–271</external-xref>) is amended—</text><subparagraph id="H955E093761CA4E9DA21850B1D978AD80" commented="no" display-inline="no-display-inline"><enum>(A)</enum><text>by striking the section heading and inserting <quote><header-in-text level="section" style="OLC">CAREER Act; Recovery Housing Pilot Program</header-in-text></quote>;</text></subparagraph><subparagraph id="H94B9D8BE1913441B9FD2201570EA8706" commented="no" display-inline="no-display-inline"><enum>(B)</enum><text display-inline="yes-display-inline">in subsection (a), by striking <quote>through 2023</quote> and inserting <quote>through 2029</quote>;</text></subparagraph><subparagraph id="HF3B56C3112C74E9D9827EB65A6E8E55D" commented="no" display-inline="no-display-inline"><enum>(C)</enum><text>in subsection (b)—</text><clause id="H10C1E13DFB5C473780054DAA90A5B7E8" commented="no" display-inline="no-display-inline"><enum>(i)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>not later than 60 days after the date of enactment of this Act</quote> and inserting <quote>not later than 60 days after the date of enactment of <short-title>SUPPORT for Patients and Communities Reauthorization Act of 2025</short-title></quote>; and</text></clause><clause id="HE01757D974F44407BD2D001AD8244F25" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text>in paragraph (2)(B)(i)—</text><subclause id="H754DE8CA91344834AE21B449931446E7" commented="no" display-inline="no-display-inline"><enum>(I)</enum><text display-inline="yes-display-inline">in subclause (I)—</text><item id="H961A009452FF4DF890C5AD5F7F34E496" commented="no" display-inline="no-display-inline"><enum>(aa)</enum><text display-inline="yes-display-inline">by striking <quote>for calendar years 2013 through 2017</quote>; and</text></item><item id="H5B43A088F8CF4223BEDEE485764663E0" commented="no" display-inline="no-display-inline"><enum>(bb)</enum><text display-inline="yes-display-inline">by inserting <quote>for calendar years 2018 through 2022</quote> after <quote>rates of unemployment</quote>;</text></item></subclause><subclause id="H74A23E438DD14A18AD734BB564E0B008" commented="no"><enum>(II)</enum><text>in subclause (II)—</text><item id="HF8FD700EA6A0456C83B727D5B96B326D" commented="no" display-inline="no-display-inline"><enum>(aa)</enum><text display-inline="yes-display-inline">by striking <quote>for calendar years 2013 through 2017</quote>; and</text></item><item id="H253CBCC9593B4775A6F512AFCC88778B" commented="no" display-inline="no-display-inline"><enum>(bb)</enum><text display-inline="yes-display-inline">by inserting <quote>for calendar years 2018 through 2022</quote> after <quote>participation rates</quote>; and</text></item></subclause><subclause id="H8404BA5DB4FF45FE9957CDE9B800C17B" commented="no" display-inline="no-display-inline"><enum>(III)</enum><text display-inline="yes-display-inline">by striking subclause (III) and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H4A583F3473F240FABA3FD274D194AA33"><subclause id="H5160FB33426C4628A7F72E28B7AD2892" commented="no"><enum>(III)</enum><text>The highest age-adjusted average rates of drug overdose deaths for calendar years 2018 through 2022 based on data from the Centers for Disease Control and Prevention, including, if necessary, provisional data for calendar year 2022.</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subclause></clause></subparagraph><subparagraph id="H4EA0111C781740549B03749BA82F7DDF" commented="no" display-inline="no-display-inline"><enum>(D)</enum><text>in subsection (f), by striking <quote>For the 2-year period following the date of enactment of this Act, the</quote> and inserting <quote>The</quote>.</text></subparagraph></paragraph><paragraph id="HFC92ED4763C04445A0EFE43ADBE33B91" commented="no"><enum>(2)</enum><header>Conforming amendment</header><text>Subtitle F of title VIII of the SUPPORT for Patients and Communities Act (<external-xref legal-doc="public-law" parsable-cite="pl/115/271">Public Law 115–271</external-xref>; 132 Stat. 4095) is amended by striking the subtitle heading and inserting the following: <quote><header-in-text level="subtitle" style="OLC"><enum-in-header>Subtitle F</enum-in-header>—CAREER Act; Recovery Housing Pilot Program</header-in-text></quote><header-in-text level="subtitle" style="OLC">.</header-in-text></text></paragraph></subsection><subsection id="H776C862FDEDA4C05ADA54A16FBFB4F8F"><enum>(c)</enum><header>Clerical amendments</header><text>The table of contents in section 1(b) of the SUPPORT for Patients and Communities Act (<external-xref legal-doc="public-law" parsable-cite="pl/115/271">Public Law 115–271</external-xref>; 132 Stat. 3894) is amended—</text><paragraph id="HBAA75EFFCF6E4D9EACA78EB604AC9C0C"><enum>(1)</enum><text>by striking the item relating to section 7183 and inserting the following:</text><quoted-block id="H0B6F904FB1F342ADAA1BE74E9CFE14C3" style="OLC"><toc regeneration="no-regeneration"><toc-entry level="section">Sec. 7183. CAREER Act; treatment, recovery, and workforce support grants.</toc-entry></toc><after-quoted-block>;</after-quoted-block></quoted-block></paragraph><paragraph id="HBC68E38A19B64EB68CB10B3D673CE498"><enum>(2)</enum><text>by striking the item relating to subtitle F of title VIII and inserting the following:</text><quoted-block style="OLC" id="H1FA6347988C349DE8DF165EC904F0DEA" display-inline="no-display-inline"><toc regeneration="no-regeneration"><toc-entry level="subtitle">Subtitle F—CAREER Act; Recovery Housing Pilot Program</toc-entry></toc><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="HFF227C57518A4D6182B3FDB797B982F0"><enum>(3)</enum><text>by striking the item relating to section 8071 and inserting the following:</text><quoted-block style="OLC" id="H367B025460994CD095C55BA1454C56DC" display-inline="no-display-inline"><toc regeneration="no-regeneration"><toc-entry level="section">Sec. 8071. CAREER Act; Recovery Housing Pilot Program.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section><section id="HCA25DEC9E200453088A0AA1EBBA02092" section-type="subsequent-section" commented="no"><enum>546.</enum><header>Addressing economic and workforce impacts of the opioid crisis</header><text display-inline="no-display-inline">Section 8041(g)(1) of the SUPPORT for Patients and Communities Act (<external-xref legal-doc="usc" parsable-cite="usc/29/3225a">29 U.S.C. 3225a(g)(1)</external-xref>) is amended by striking <quote>2023</quote> and inserting <quote>2029</quote>.</text></section></subtitle><subtitle id="HA90D2D930039477DB5EDBF73AB506DD1"><enum>D</enum><header>Miscellaneous matters</header><section id="H69DF392E13FB4ACFB26280C916720D6F"><enum>551.</enum><header>Delivery of a controlled substance by a pharmacy to a prescribing practitioner</header><text display-inline="no-display-inline">Section 309A(a) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/829a">21 U.S.C. 829a(a)</external-xref>) is amended by striking paragraph (2) and inserting the following:</text><quoted-block id="HFE7CA8B59BC04F2CBAC87800B3E5D185" style="OLC"><paragraph id="H53947C6A5EFD4A3A82211D413B861FF1"><enum>(2)</enum><text>the controlled substance is a drug in schedule III, IV, or V to be administered—</text><subparagraph id="HC08C0BC7D3144A808ED53286207EF5CD"><enum>(A)</enum><text>by injection or implantation for the purpose of maintenance or detoxification treatment; or</text></subparagraph><subparagraph id="H4C6CC05F075846C089552E2962F37543"><enum>(B)</enum><text>subject to a risk evaluation and mitigation strategy pursuant to section 505–1 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C. 355–1</external-xref>) that includes elements to assure safe use of the drug described in subsection (f)(3)(E) of such section, including a requirement for post-administration monitoring by a health care provider.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="HEA2C615CF0644AF2BA0E4A8C2F5039AE"><enum>552.</enum><header>Technical correction on controlled substances dispensing</header><text display-inline="no-display-inline">Effective as if included in the enactment of <external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref>—</text><paragraph id="H1140631286BF4E468D6003EB6ABE11CD"><enum>(1)</enum><text>section 1252(a) of division FF of <external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref> (136 Stat. 5681) is amended, in the matter being inserted into section 302(e) of the Controlled Substances Act, by striking <quote>303(g)</quote> and inserting <quote>303(h)</quote>;</text></paragraph><paragraph id="H6AF6BED89F054FFA851BDD76F750DE52"><enum>(2)</enum><text>section 1262 of division FF of <external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref> (136 Stat. 5681) is amended—</text><subparagraph id="H8DFEEA78A08F4EB4B31EF6D8A99F52D8"><enum>(A)</enum><text>in subsection (a)—</text><clause id="HAA5BC2CC1DD34D3D8C3015D3621BCB0B"><enum>(i)</enum><text>in the matter preceding paragraph (1), by striking <quote>303(g)</quote> and inserting <quote>303(h)</quote>;</text></clause><clause id="H7FDD2C41E23B491CAD5E4DE91489FE7C"><enum>(ii)</enum><text>in the matter being stricken by subsection (a)(2), by striking <quote>(g)(1)</quote> and inserting <quote>(h)(1)</quote>; and</text></clause><clause id="H2BAD9C08B54A49B58DEA53D2DE14AD99"><enum>(iii)</enum><text>in the matter being inserted by subsection (a)(2), by striking <quote>(g) Practitioners</quote> and inserting <quote>(h) Practitioners</quote>; and</text></clause></subparagraph><subparagraph id="HD39173B8552A456DB2B8F14B4202E155"><enum>(B)</enum><text>in subsection (b)—</text><clause id="H2295C77F12E34A9E894CFF8D84E4BACD"><enum>(i)</enum><text>in the matter being stricken by paragraph (1), by striking <quote>303(g)(1)</quote> and inserting <quote>303(h)(1)</quote>;</text></clause><clause id="HAB97EDBC251F45C781DED16575EEBF18"><enum>(ii)</enum><text>in the matter being inserted by paragraph (1), by striking <quote>303(g)</quote> and inserting <quote>303(h)</quote>;</text></clause><clause id="H896C2B7E2D2B45D08531C7C7D2D0473F"><enum>(iii)</enum><text>in the matter being stricken by paragraph (2)(A), by striking <quote>303(g)(2)</quote> and inserting <quote>303(h)(2)</quote>;</text></clause><clause id="H1AB5978E9E094900AD365DF40292F296"><enum>(iv)</enum><text>in the matter being stricken by paragraph (3), by striking <quote>303(g)(2)(B)</quote> and inserting <quote>303(h)(2)(B)</quote>;</text></clause><clause id="H0BC9C424E10744F09AF43C55864F03B3"><enum>(v)</enum><text>in the matter being stricken by paragraph (5), by striking <quote>303(g)</quote> and inserting <quote>303(h)</quote>; and</text></clause><clause id="H4F82D0A607D94352BDEFC8041C1F6EE6"><enum>(vi)</enum><text>in the matter being stricken by paragraph (6), by striking <quote>303(g)</quote> and inserting <quote>303(h)</quote>; and</text></clause></subparagraph></paragraph><paragraph id="H505F5CDA92EA431AA029BC7A94FC0D0B"><enum>(3)</enum><text>section 1263(b) of division FF of <external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref> (136 Stat. 5685) is amended—</text><subparagraph id="HDE7A59B214424C0D90C6935C96BF75AB"><enum>(A)</enum><text>by striking <quote>303(g)(2)</quote> and inserting <quote>303(h)(2)</quote>; and</text></subparagraph><subparagraph id="HCC89CE8DA660457782FE1CDD2B069255"><enum>(B)</enum><text>by striking <quote>(<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823(g)(2)</external-xref>)</quote> and inserting <quote>(<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823(h)(2)</external-xref>)</quote>.</text></subparagraph></paragraph></section><section id="H1AD8EE7914CD4A048B9A6D5FD3A74781"><enum>553.</enum><header>Required training for prescribers of controlled substances</header><subsection id="H8AACA0F1432D403D9C3366406601F4B3"><enum>(a)</enum><header>In general</header><text>Section 303 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823</external-xref>) is amended—</text><paragraph id="H5C6D6E2E424A41A0882C5D5DA84746E8"><enum>(1)</enum><text>by redesignating the second subsection designated as subsection (l) as subsection (m); and</text></paragraph><paragraph id="HB80B189298AF46B3B1FE464BD414BF75"><enum>(2)</enum><text>in subsection (m)(1), as so redesignated—</text><subparagraph id="HA034C4D3B5AC4332AEBE008A9F28A2B7"><enum>(A)</enum><text>in subparagraph (A)—</text><clause id="H62A7B3EF9AFE470B811C9613D55BE6E1"><enum>(i)</enum><text>in clause (iv)—</text><subclause id="H6F268A4EAE3646EAB3E7069A6D6DAF48"><enum>(I)</enum><text>in subclause (I)—</text><item id="HC0526B731570495F9C5EBBEA4BF7B0CE"><enum>(aa)</enum><text>by inserting <quote>the American Academy of Family Physicians, the American Podiatric Medical Association, the Academy of General Dentistry, the American Optometric Association,</quote> before <quote>or any other organization</quote>;</text></item><item id="HAF0D4C4E80484D9FBF93EE8D3D704AD2"><enum>(bb)</enum><text>by striking <quote>or the Commission</quote> and inserting <quote>the Commission</quote>; and</text></item><item id="HF8FD38D8A39544D4B74ED6EAFD075FB6"><enum>(cc)</enum><text>by inserting <quote>, or the Council on Podiatric Medical Education</quote> before the semicolon at the end; and</text></item></subclause><subclause id="H26E7AA4200C34D70A6320F8A3B69CDC9"><enum>(II)</enum><text>in subclause (III), by inserting <quote>or the American Academy of Family Physicians</quote> after <quote>Association</quote>; and</text></subclause></clause><clause id="HE8093276EE554F5DAADFF1F4D73DA446"><enum>(ii)</enum><text>in clause (v), in the matter preceding subclause (I)—</text><subclause id="H571207FD274E41699C5A9768893C63BB"><enum>(I)</enum><text>by striking <quote>osteopathic medicine, dental surgery</quote> and inserting <quote>osteopathic medicine, podiatric medicine, dental surgery</quote>; and</text></subclause><subclause id="H92C13E43D5B948E2B70A25A79AAABEDE"><enum>(II)</enum><text>by striking <quote>or dental medicine curriculum</quote> and inserting <quote>or dental or podiatric medicine curriculum</quote>; and</text></subclause></clause></subparagraph><subparagraph id="H7DF6C4D9FF734FD88E09B4B99C3B80E1"><enum>(B)</enum><text>in subparagraph (B)—</text><clause id="HE29DF92BC4724D29A9B25EA013A6334F"><enum>(i)</enum><text>in clause (i)—</text><subclause id="HB9FF32341C5E49B6B75B2004637361F8"><enum>(I)</enum><text>by inserting <quote>the American Pharmacists Association, the Accreditation Council on Pharmacy Education, the American Psychiatric Nurses Association, the American Academy of Nursing, the American Academy of Family Physicians,</quote> before <quote>or any other organization</quote>; and</text></subclause><subclause id="H47959CC80E934C318F91F12DD8C3AF37"><enum>(II)</enum><text>by inserting <quote>, the American Academy of Family Physicians,</quote> before <quote>or the Accreditation Council</quote>; and</text></subclause></clause><clause id="H78E706BADF3341C18DEAC01CAF88B85A"><enum>(ii)</enum><text>in clause (ii)—</text><subclause id="HD59E224027634FA098620896FA4B1D3A"><enum>(I)</enum><text>by striking <quote>or accredited school</quote> and inserting <quote>, an accredited school</quote>; and</text></subclause><subclause id="HC72DAF806A6B4D92A51D3D6F39CE6A23"><enum>(II)</enum><text>by inserting <quote>, or an accredited school of pharmacy</quote> before <quote>in the United States</quote>.</text></subclause></clause></subparagraph></paragraph></subsection><subsection id="H1BB2BD89D1414C9CAF8A6CBFD88A9C4B"><enum>(b)</enum><header>Effective date</header><text>The amendment made by subsection (a) shall take effect as if enacted on December 29, 2022.</text></subsection></section><section id="H9D9B590F9A594D219E1066152D95E0AE" section-type="subsequent-section"><enum>554.</enum><header>Extension of temporary order for fentanyl-related substances</header><text display-inline="no-display-inline">Effective as if included in the enactment of the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act (<external-xref legal-doc="public-law" parsable-cite="pl/116/114">Public Law 116–114</external-xref>), section 2 of such Act is amended by striking <quote>March 31, 2025</quote> and inserting <quote>September 30, 2026</quote>.</text></section></subtitle></title><title id="HBF5129531056445AACB9851334A369F5" style="OLC"><enum>VI</enum><header>Pandemic and All-Hazards Preparedness and Response</header><section id="H838A2E6E1E1D4214A8EA3D594AFB17EF"><enum>601.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote>Pandemic and All-Hazards Preparedness and Response Act</quote>.</text></section><subtitle id="HFD4FA6ABE3344AFD84A5A6077889A436" style="OLC"><enum>A</enum><header>State and local readiness and response</header><section id="H23C4A5B30C3048BAA4CCD13527F7AA63"><enum>611.</enum><header>Temporary reassignment of State and local personnel during a public health emergency</header><text display-inline="no-display-inline">Section 319(e) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d">42 U.S.C. 247d(e)</external-xref>) is amended—</text><paragraph id="H3CB445C7EF534F7EBFE5387AB2950707"><enum>(1)</enum><text>in paragraph (1), by striking <quote>tribal organization or such Governor or tribal organization's designee</quote> and inserting <quote>Tribal organization or the designee of the Governor or Tribal organization, or the State or Tribal health official</quote>;</text></paragraph><paragraph id="H6FCA2E9A99C944B1B693A97D7E1238F5"><enum>(2)</enum><text>in paragraph (2)(B)—</text><subparagraph commented="no" display-inline="no-display-inline" id="HCE095A44A6854A5DADC73A1471A85340"><enum>(A)</enum><text>in the matter preceding clause (i), by striking <quote>tribal organization</quote> and inserting <quote>Tribal organization, or the State or Tribal health official</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBC577B35B5C64455A307D5F81A90CAB3"><enum>(B)</enum><text>in clause (v), by striking <quote>tribal organization</quote> and inserting <quote>Tribal organization or State or Tribal health official</quote>;</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H306611218CF04067B12626F5960FA398"><enum>(3)</enum><text>in paragraph (6)—</text><subparagraph id="H7DB74AD241C14140B355CE475129C8AC"><enum>(A)</enum><text>in the matter preceding subparagraph (A)—</text><clause commented="no" display-inline="no-display-inline" id="H57C79A4201FF4F939BA12BB788FA3633"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>Reauthorization Act of 2013</quote> and inserting <quote>and Response Act</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H8F18AFEE07264E5BB2E74D399699167D"><enum>(ii)</enum><text>by striking <quote>appropriate committees of the Congress</quote> and inserting <quote>Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives</quote>; and</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HBACEE985680F4818B69C3C8BB428A1C6"><enum>(B)</enum><text>in subparagraph (A), by inserting <quote>, including requests from State or Tribal health officials</quote> before the semicolon; </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3B8A32729C3B43529F00B0E9EF35865E"><enum>(4)</enum><text>in paragraph (7)(A), by striking <quote>tribal organization</quote> and inserting <quote>Tribal organization</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H332D74B5427D48209FEE960379560FCA"><enum>(5)</enum><text>in paragraph (8), by striking <quote>March 31, 2025</quote> and inserting <quote>December 31, 2026</quote>.</text></paragraph></section><section id="H37C2671ABA914199913E7D5533BA75DC"><enum>612.</enum><header>Public Health Emergency Preparedness program</header><text display-inline="no-display-inline">Section 319C–1 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-3a">42 U.S.C. 247d–3a</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H803DD6D030814AB7964C4B14D95C2361"><enum>(1)</enum><text>in subsection (b)(2)—</text><subparagraph commented="no" display-inline="no-display-inline" id="H2069AE1879684CFF823CA4E72C76A1F0"><enum>(A)</enum><text>in subparagraph (A)(ii), by striking <quote>influenza</quote> and inserting <quote>response planning</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA6A5C331A8CE48A8B1BC423C96905D11"><enum>(B)</enum><text>in subparagraph (H), by inserting <quote>, such as community-based organizations, including faith-based organizations, and other public and private entities</quote> after <quote>stakeholders</quote>; </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF547F6001E2F480FBCF429D95E1A47D0"><enum>(2)</enum><text>in subsection (g)—</text><subparagraph commented="no" display-inline="no-display-inline" id="HFB00735090084466B6D08C8628D2BD0E"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), in the matter preceding subparagraph (A), by inserting <quote>and the ability of each entity receiving an award under subsection (a) to respond to all-hazards threats</quote> before the period at the end of the first sentence; </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5B3ADA6725A34D5380B29BA8CB01378A"><enum>(B)</enum><text>in paragraph (2)—</text><clause id="H579C31C2E75C4EB19DCB67AB8A27F5B1"><enum>(i)</enum><text>in the paragraph heading, by striking <quote><header-in-text level="paragraph" style="OLC">influenza</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">response</header-in-text></quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H560029D559B04DC9991385CA00433DDC"><enum>(ii)</enum><text>in subparagraph (A)—</text><subclause commented="no" display-inline="no-display-inline" id="H0B5818B86C4941AA8239274A8A89D154"><enum>(I)</enum><text>by striking <quote>to pandemic influenza</quote> and inserting <quote>to a pathogen causing a pandemic, including pandemic influenza</quote>; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HD0ED04B444DC4CD2A4F8EB2811D86C4A"><enum>(II)</enum><text>by striking <quote>such pandemic influenza</quote> and inserting <quote>such pandemic response</quote>;</text></subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF72CC4990EB749B49F93BF9CBDEF36C3"><enum>(C)</enum><text>in paragraph (5)—</text><clause commented="no" display-inline="no-display-inline" id="H0E7ED6FBE4B6454D9F44D8412E9C3512"><enum>(i)</enum><text>in the paragraph heading, by striking <quote><header-in-text level="paragraph" style="OLC">influenza</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">pandemic response</header-in-text></quote>; </text></clause><clause commented="no" display-inline="no-display-inline" id="HF507008205C145AF9A45E0C31D086498"><enum>(ii)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph (A), by striking <quote>2019</quote> and inserting <quote>2026</quote>;</text></clause><clause commented="no" display-inline="no-display-inline" id="H3C8114DAF946491395F33935AC7BADE6"><enum>(iii)</enum><text>in subparagraph (A), by striking <quote>2018</quote> and inserting <quote>2025</quote>; and</text></clause><clause id="HB07E6D08904C4407B96BDB2AD30DAF8C"><enum>(iv)</enum><text>in subparagraph (B), by striking <quote>pandemic influenza</quote> and inserting <quote>a pathogen causing a pandemic</quote>; and</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4ADD45ABAD5D43BD98D08FB2750591F5"><enum>(D)</enum><text>in paragraph (6)—</text><clause commented="no" display-inline="no-display-inline" id="H0A52A26874014B50B17AFB9E2431EFC3"><enum>(i)</enum><text>in subparagraph (A), in the matter preceding clause (i), by striking <quote>The amounts described in this paragraph are the following amounts that are payable to an entity for activities described in this section or section 319C–2</quote> and inserting <quote>The Secretary shall withhold from an entity pursuant to paragraph (5) for noncompliance with the requirements of this section or section 319C–2 as follows</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="HAC0426595AF6400592E2B49D233B25C8"><enum>(ii)</enum><text>in subparagraph (B), by inserting <quote>with respect to the requirements of this section or section 319C–2</quote> after <quote>paragraph (5)</quote>; and</text></clause></subparagraph></paragraph><paragraph id="HC6CF12FC04264E5BA5B95656FE2F753D" commented="no"><enum>(3)</enum><text>in subsection (h)(1)(A), by striking <quote>$685,000,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$735,000,000 for each of fiscal years 2025 and 2026, to remain available through December 31, 2026</quote>.</text></paragraph></section><section id="H235B5E1580EC4179A3A631DFE9EA2374"><enum>613.</enum><header>Hospital Preparedness Program</header><subsection commented="no" display-inline="no-display-inline" id="HFDFB540D01304EAEB11C95642D0A0595"><enum>(a)</enum><header>Increasing participation by EMS in the hospital preparedness program</header><paragraph commented="no" display-inline="no-display-inline" id="HFA586CCA95FF4F31981F3BB60B1D6229"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text>Section 319C–2 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-3b">42 U.S.C. 247d–3b</external-xref>) is amended—</text><subparagraph commented="no" display-inline="no-display-inline" id="H2F8F7BE26F7943BEA83C4F742A910031"><enum>(A)</enum><text>in subsection (b)(1)(A)—</text><clause commented="no" display-inline="no-display-inline" id="H19EAD980FC92403BA0442908381672BE"><enum>(i)</enum><text display-inline="yes-display-inline">in clause (iii)(III), by striking <quote>; and</quote> and inserting a semicolon; and</text></clause><clause commented="no" display-inline="no-display-inline" id="HACFA6AB642924F4B9701E047E81AB34C"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking clause (iv) and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H7AF2B8E057174E6AA862B33178BB0090"><clause id="H5661ED0199CF4D21A2C1E71114587D54"><enum>(iv)</enum><text>one or more emergency medical service organizations; and</text></clause><clause id="H4DFBB890ACCB4C3C9FDDA6D3545F69F4"><enum>(v)</enum><text>to the extent practicable, one or more emergency management organizations; and</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA0F8F73AE41E4564B5144475EB4E03AB"><enum>(B)</enum><text>in subsection (g)(1)—</text><clause id="HB9372CE2199F417B956E3085F7ED811C"><enum>(i)</enum><text>by striking <quote>(1) <header-in-text level="paragraph" style="OLC">Local response capabilities</header-in-text></quote> and inserting:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HBF78F4A1FBBD4C8D92DE092DA5A964C8"><paragraph id="HDCFBB4F290544FDCA56E1B69F12596B0"><enum>(1)</enum><header>Local response capabilities</header><subparagraph id="H067C497E57974356886AF5F86FBAB8FA"><enum>(A)</enum><header>Program coordination</header></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></clause><clause commented="no" display-inline="no-display-inline" id="H30CC9C0B721C4EA5B25BE7E335BD6328"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>extent practicable, ensure</quote> and inserting the following: “extent practicable—</text><quoted-block style="OLC" display-inline="no-display-inline" id="HE1B6C8569EE94920BADAF55CF215AC5F"><clause commented="no" display-inline="no-display-inline" id="H93E78E9BF22A42F9ACB87432E63CAB8C"><enum>(i)</enum><text display-inline="yes-display-inline">ensure</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></clause><clause commented="no" display-inline="no-display-inline" id="H527A41BC0AE9406BBAFD71DC961B2BC3"><enum>(iii)</enum><text>by striking the period and inserting <quote>; and</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H032022FA69E64CE8876AEC4C75C72989"><enum>(iv)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HE35660C218CC481DB4A0FEEDC980A74B"><clause id="HE7B1746CAA224757A7505D85DF799A97"><enum>(ii)</enum><text>seek to increase participation of eligible entities described in subsection (b)(1)(A) with lower participation rates relative to other eligible entities, such as emergency medical services organizations and health care facilities in underserved areas.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph></paragraph><paragraph id="H258FF671839A44B493619C0E43234EAA"><enum>(2)</enum><header>Preferences</header><text>Section 319C–2(d)(1)(A)(iii) of the Public Health Service Act (42 U.S.C. 247d–3b(d)(1)(A)(iii)) is amended by striking <quote>subsection (b)(1)(A)(ii)</quote> and inserting <quote>clauses (ii) and (iv) of subsection (b)(1)(A)</quote>.</text></paragraph></subsection><subsection id="HD7691FBB0B494EF6996EB628B3F62E8B"><enum>(b)</enum><header>Improving medical readiness and response capabilities</header><text display-inline="yes-display-inline">Section 319C–2 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-3b">42 U.S.C. 247d–3b</external-xref>) is amended—</text><paragraph id="HF130F306F88548148004E9BF50DDB1B1"><enum>(1)</enum><text>in subsection (b)(2)—</text><subparagraph id="H1604D1E76F974C9E938C714E6E943B43"><enum>(A)</enum><text>in subparagraph (A), by striking <quote>and</quote> at the end;</text></subparagraph><subparagraph id="H81838DB5B84A46DA9DC96F86A0892937"><enum>(B)</enum><text>in subparagraph (B), by striking the period and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph id="H4965B90E4F9E471797780FDB4E56B9AE"><enum>(C)</enum><text>by inserting at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HBCCA46BA760741BEB4C3A8BCFFD269BD"><subparagraph id="HAECDEA9869B9443CB45A20D772637017" indent="up1"><enum>(C)</enum><text>designate a lead entity to administer such award and support coordination between entities described in this subsection.</text></subparagraph><after-quoted-block>; </after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H36E2701BF58C4E52B7521D614D6624AB"><enum>(2)</enum><text>in subsection (g)(1), as amended by subsection (a)(1)(B), by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HB4525CE015CB41C6B2E756D42C4F0C7D"><subparagraph id="H92F3EC85C0CB4FFEA9C358BC011E79AB"><enum>(B)</enum><header>Regional operations</header><text>An eligible entity shall establish and maintain, or leverage an existing, capability to enable coordination of regional medical operations, which may include systems to facilitate information sharing and coordination, within a coalition described under subsection (b)(1)(A) and, as appropriate, among multiple coalitions that are in close geographic proximity to each other.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4865FD64DAB1416BADAADAAB3033B9EE"><enum>(3)</enum><text>in subsection (j)(1)—</text><subparagraph commented="no" display-inline="no-display-inline" id="H62EB96FDB78C4A53AEA18450C22F8036"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking <quote>for each of fiscal years 2019 through 2023</quote> and inserting <quote>for each of fiscal years 2025 and 2026, to remain available through December 31, 2026</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H127FFA4AA29746A69757070388C2F2E8"><enum>(B)</enum><text>in subparagraph (B)(iii), by striking <quote>September 30, 2023</quote> and inserting <quote>December 31, 2026</quote>.</text></subparagraph></paragraph></subsection></section><section id="HDA2E56CF0ABC468DAFE6F978016A22EF" commented="no"><enum>614.</enum><header>Facilities and capacities of the Centers for Disease Control and Prevention to combat public health security threats</header><text display-inline="no-display-inline">Section 319D(h) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-4">42 U.S.C. 247d–4(h)</external-xref>) is amended—</text><paragraph id="H0E8A0250FD7147C3A30A813D9C99E23E" commented="no"><enum>(1)</enum><text>in paragraph (1), by striking <quote>$25,000,000 for each of fiscal years 2022 and 2023</quote> and inserting <quote>$40,000,000 for each of fiscal years 2025 and 2026, to remain available through December 31, 2026</quote>; and</text></paragraph><paragraph id="H0F82CF74ED0747B2B7AA1BA2D05E3F5F" commented="no"><enum>(2)</enum><text>in paragraph (2), by striking <quote>2022 and 2023</quote> and inserting <quote>2025 and 2026, to remain available through December 31, 2026</quote>.</text></paragraph></section><section id="HFBAE642E81E144ADA59103B97257C055" commented="no"><enum>615.</enum><header>Pilot program to support State medical stockpiles</header><subsection commented="no" display-inline="no-display-inline" id="H86050BECB799424B91643C58B6D33A47"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 319F–2(i) of the Public Health Service Act (42 U.S.C. 247d–6b(i)) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="HC396DA00ACC346FDB3F2448882404871"><enum>(1)</enum><text>in paragraph (2)(B)(i)—</text><subparagraph commented="no" display-inline="no-display-inline" id="HD97D30D2B8BA4339904AFB3D012195D1"><enum>(A)</enum><text>in subclause (I), by striking <quote>and 2024</quote> and inserting <quote>through 2025</quote>; and</text></subparagraph><subparagraph id="H88A20B9A91014377B7C39A5E4C15CC71" commented="no"><enum>(B)</enum><text>in subclause (II), by striking <quote>2025</quote> and inserting <quote>2026</quote>;</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H176550279C7E454883080FC2B4510894"><enum>(2)</enum><text>in paragraph (4)—</text><subparagraph commented="no" display-inline="no-display-inline" id="H98DA4F45155F4926B716B1265BBA667E"><enum>(A)</enum><text>in subparagraph (G), by striking <quote>; and</quote> at the end and inserting a semicolon;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H57EC16A055AE4DEF9EDEC5B324987BC7"><enum>(B)</enum><text display-inline="yes-display-inline">by redesignating subparagraph (H) as subparagraph (I); </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HDC6CC85FC2874C97962E6F9C2E102A97"><enum>(C)</enum><text display-inline="yes-display-inline">by inserting after subparagraph (G) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HBA6B7A74DCEE42C6A1FDC5E5460937E0"><subparagraph id="H94EFE09B30D648B584F530E572F4D288" commented="no"><enum>(H)</enum><text>facilitate the sharing of best practices among States within a consortia of States in receipt of funding related to establishing and maintaining a stockpile of medical products; and </text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H963FFE8C36854E49B29F732623CB1878"><enum>(D)</enum><text>in subparagraph (I), as so redesignated, by striking <quote>State efforts</quote> and inserting <quote>State or regional efforts</quote>; </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HA6F20F7BD2824B8BB00E8E065307A113"><enum>(3)</enum><text>by redesignating paragraphs (5) through (9) as paragraphs (6) through (10), respectively;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0BCE4AA3F75543E6B4F67F8D2C65298C"><enum>(4)</enum><text display-inline="yes-display-inline">by inserting after paragraph (4) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H02136E358CCD4A618F9F2051A71460D6"><paragraph id="HD51E9495202444E7A735D72C96192AB9" commented="no"><enum>(5)</enum><header>Coordination</header><text>An entity in receipt of an award under paragraph (1), in carrying out the activities under this subsection, shall coordinate with appropriate health care entities, health officials, and emergency management officials within the jurisdiction of such State or States.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="HE8D3BAC97FF64913AB3ACEDC039CD51C" commented="no"><enum>(5)</enum><text>in paragraph (10), as so redesignated, by striking <quote>$3,500,000,000 for each of fiscal years 2023 and 2024</quote> and inserting <quote>$3,365,000,000 for fiscal year 2025, and $3,265,000,000 for fiscal year 2026</quote>.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HE7A905011F0E46A9A86ADFB219094E4A"><enum>(b)</enum><header>GAO report</header><text>Section 2409(b) of the PREVENT Pandemics Act (<external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="HA03C34310E08461B9D9D49C1828F52BA"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (2), by striking <quote>; and</quote> and inserting a semicolon;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1D30540E4A7C4CD38B85E9711411B9EE"><enum>(2)</enum><text>in paragraph (3), by striking the period and inserting <quote>; and</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC132779F3C8942F991C1DA221C1A9C34"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HFDA84EAE036F4BCC96AFC68088DA079A"><paragraph id="H3B9EFCD613BF441D82253DD9F6121D83" commented="no"><enum>(4)</enum><text>the impact of any regional stockpiling approaches carried out under subsection (i)(1) of section 319F–2 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6b">42 U.S.C. 247d–6b</external-xref>).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="H2B8A6D3BA39C446E8B985E6B660D94EC"><enum>616.</enum><header>Enhancing domestic wastewater surveillance for pathogen detection</header><subsection commented="no" display-inline="no-display-inline" id="H77A7D4B361944BD2BB9AA7FED96DE75A"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Title III of the Public Health Service Act is amended by inserting after section 317V (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-24">42 U.S.C. 247b–24</external-xref>) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H1C4A98F661F8474388B97FFC6D708F11"><section id="HAB9618B28DD24E1386B5580DAA005AC3"><enum>317W.</enum><header>Wastewater surveillance for pathogen detection</header><subsection commented="no" display-inline="no-display-inline" id="HF4A328BD3A26447D8288F185AC948557"><enum>(a)</enum><header display-inline="yes-display-inline">Wastewater surveillance system</header><text display-inline="yes-display-inline">The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in coordination with other Federal departments and agencies, shall award grants, contracts, or cooperative agreements to eligible entities to establish, maintain, or improve activities related to the detection and monitoring of infectious diseases through wastewater for public health emergency preparedness and response purposes.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="H132A43491B95474094AF4E362BC87209"><enum>(b)</enum><header>Eligible entities</header><text>To be eligible to receive an award under this section, an entity shall—</text><paragraph commented="no" display-inline="no-display-inline" id="H7406D638D672480F9F8E24AC7C5200C2"><enum>(1)</enum><text display-inline="yes-display-inline">be a State, Tribal, or local health department, or a partnership between such a health department and other public and private entities; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1DA87A0068A44759B5C98C30C2D2364C"><enum>(2)</enum><text display-inline="yes-display-inline">submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may reasonably require, which shall include—</text><subparagraph id="H6747178846D749F99C8D4BEFF8454252"><enum>(A)</enum><text>a description of activities proposed to be carried out pursuant to an award under subsection (a);</text></subparagraph><subparagraph id="H0689CB6C69F944039649804F425533D3"><enum>(B)</enum><text>factors such entity proposes to use to select wastewater sampling sites;</text></subparagraph><subparagraph id="H373673DF13E440ED9DD2CFD3D18E8772"><enum>(C)</enum><text>factors such entity proposes to use to determine whether a response to findings from such wastewater sampling may be warranted, and a plan for responding, as appropriate, consistent with applicable plans developed by such entity pursuant to section 319C–1;</text></subparagraph><subparagraph id="HA1A1180F6D79430787D81163D164B2DC"><enum>(D)</enum><text>a plan to sustain such wastewater surveillance activities described in such application following the conclusion of the award period; and</text></subparagraph><subparagraph id="H4197FBBEEC4C44F5BA11547C18AACF2F"><enum>(E)</enum><text>any additional information the Secretary may require.</text></subparagraph></paragraph></subsection><subsection id="H0437E071B6FB4BE4849C320BB05192D1"><enum>(c)</enum><header>Consideration</header><text>In making awards under subsection (a), the Secretary may give priority to eligible entities that have submitted an application that—</text><paragraph id="H6206FA14286444B1A30AD5845823907A"><enum>(1)</enum><text>details plans to provide public access to deidentified data generated through such wastewater surveillance activities in a manner that allows for comparison to such data generated by other recipients of an award under subsection (a); and</text></paragraph><paragraph id="HF8DE5E847AC6464AB61F28FC7AED6E94"><enum>(2)</enum><text>provides an assessment of community needs related to ongoing infectious disease monitoring, including estimates of the incidence and prevalence of infectious diseases that can be detected in wastewater and availability, at the time of the application, of other forms of infectious disease detection in the jurisdiction.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H5A0424FBD52F4B2CA3205DE73B16BEFD"><enum>(d)</enum><header>Use of funds</header><text display-inline="yes-display-inline">An eligible entity shall, as appropriate, use amounts awarded under this section to—</text><paragraph id="HC31D1CF8CF6A474891B386D144B1EE53"><enum>(1)</enum><text>establish or enhance existing capacity and capabilities to conduct wastewater sampling, testing, and related analysis;</text></paragraph><paragraph id="H43A5883031A443BE9474DDF8AED4E0AC"><enum>(2)</enum><text>conduct wastewater surveillance, as appropriate, in areas or facilities with increased risk of infectious disease outbreaks and limited ability to utilize other forms of infectious disease detection, such as at individual facilities, institutions, and locations in rural areas or areas in which wastewater is not treated through the relevant local utility of the jurisdiction; and</text></paragraph><paragraph id="HECE301C352D44D6A932ADB26FACC91D9"><enum>(3)</enum><text>implement projects that use evidence-based or innovative practices to conduct wastewater surveillance activities.</text></paragraph></subsection><subsection id="H18D8511124264513A6745DC3A99FC834"><enum>(e)</enum><header>Partnerships</header><text>In carrying out activities under this section, eligible entities shall identify opportunities to partner with other public or private entities to leverage relevant capabilities maintained by such entities, as appropriate and consistent with this section.</text></subsection><subsection id="H0074606FE3C64B3680716FAACBA47257"><enum>(f)</enum><header>Technical assistance</header><text>The Secretary, in consultation with the heads of other applicable Federal agencies and departments, as appropriate, shall provide technical assistance to recipients of awards under this section to facilitate the planning, development, and implementation of activities described in subsection (d).</text></subsection><subsection id="HE070BC93DA474811AC4C70BA009AEED8" commented="no"><enum>(g)</enum><header>Authorization of appropriations</header><text>To carry out this section, there is authorized to be appropriated $20,000,000 for each of fiscal years 2025 and 2026, to remain available through December 31, 2026.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection commented="no" id="H6F4269C715E34FEE97FC5B81A6345C2C"><enum>(b)</enum><header>Wastewater surveillance research</header><paragraph commented="no" id="H4E9519A818764FFD871323DEB187E4BC"><enum>(1)</enum><header>In general</header><text>The Secretary of Health and Human Services (in this subsection referred to as the <quote>Secretary</quote>) shall continue to conduct or support research on the use of wastewater surveillance to detect and monitor emerging infectious diseases, which may include—</text><subparagraph commented="no" id="H572C402F9DF140DB914518D1F3A3FA56"><enum>(A)</enum><text>research to improve the efficiency and effectiveness of wastewater sample collection and analysis and increase the sensitivity and specificity of wastewater testing methods; and</text></subparagraph><subparagraph commented="no" id="H94E63EA6B19E4827A4E401F8446E2857"><enum>(B)</enum><text>implementation and development of evidence-based practices to facilitate the estimation of the incidence and prevalence of infectious disease within a community.</text></subparagraph></paragraph><paragraph commented="no" id="H189B2A8535D3411E9EE274AC31115493"><enum>(2)</enum><header>Non-duplication of effort</header><text>The Secretary shall ensure that activities carried out under this subsection do not unnecessarily duplicate efforts of other agencies and offices within the Department of Health and Human Services related to wastewater surveillance.</text></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="HD3BFEBB461754E0E902E002860907FCF"><enum>617.</enum><header display-inline="yes-display-inline">Reauthorization of Mosquito Abatement for Safety and Health program</header><text display-inline="no-display-inline">Section 317S of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-21">42 U.S.C. 247b–21</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="HDE93B8A323B643FDAB0B85B19D71C4CB"><enum>(1)</enum><text>in subsection (a)(3)(A), by striking <quote>subsection (b)(3)</quote> and inserting <quote>subsection (b)(4)</quote>;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HAA035D2D905E4A63BBE1CCF314010B23"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)—</text><subparagraph commented="no" display-inline="no-display-inline" id="HCD4CA39190B547B296BD93CDF0DEFC90"><enum>(A)</enum><text>by redesignating paragraphs (3) through (6) as paragraphs (4) through (7), respectively; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H7929FA07AC2A4988952A267F29B9ABB0"><enum>(B)</enum><text>by inserting after paragraph (2) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H617BB0ED24C04A0A8DADF8C90E0690F3"><paragraph id="H55FB110D1A114B82AF2A4A5696B3678D"><enum>(3)</enum><header>Considerations</header><text>The Secretary may consider the use of innovative and novel technology for mosquito prevention and control in making grants under paragraph (1).</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="HB078165A6A3840F78A686764749408CA"><enum>(3)</enum><text>by amending subsection (d) to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H993070827E3844DC80415517DDBD21BB"><subsection id="HB9BFE320FEA4471E99C2B410DCFBA9D4"><enum>(d)</enum><header>Uses of funds</header><text>Amounts appropriated under subsection (f) may be used by the Secretary to provide training and technical assistance with respect to the planning, development, and operation of assessments and plans under subsection (a) and control programs under subsection (b). The Secretary may provide such training and technical assistance directly or through awards of grants or contracts to public and private entities.</text></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H547B7B55842A4567A72F2A5F3729A674"><enum>(4)</enum><text>in subsection (f)(1), by striking <quote>2019 through 2023</quote> and inserting <quote>2025 and 2026, to remain available through December 31, 2026</quote>.</text></paragraph></section></subtitle><subtitle commented="no" level-type="subsequent" style="OLC" id="H175945C3837548079E6252572ED1E462"><enum>B</enum><header>Federal planning and coordination</header><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="H8E1FCF28DA2C463989A6229093CC5196"><enum>621.</enum><header display-inline="yes-display-inline">All-Hazards Emergency Preparedness and Response</header><text display-inline="no-display-inline">Section 2811 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10">42 U.S.C. 300hh–10</external-xref>) is amended—</text><paragraph id="H0663A13CFA6641CA878B7F2A9F915DFD"><enum>(1)</enum><text>in subsection (b)—</text><subparagraph id="H7833222154E04F5EA27709B67ADE7FC4"><enum>(A)</enum><text>in paragraph (3)—</text><clause commented="no" display-inline="no-display-inline" id="HFBBC0328A48F4C55BCECC1E4867221A0"><enum>(i)</enum><text>by striking <quote>Oversee advanced research, development, and procurement</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H3CB2709D2B654891869CDECDCD47C4BE"><subparagraph id="HBC801E3F2B2C48ADB1E50794CC277145"><enum>(A)</enum><header>In general</header><text>Oversee advanced research, development, procurement, and replenishment</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause><clause commented="no" display-inline="no-display-inline" id="H3CD6646351A743479ED567DE3859ECAE"><enum>(ii)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H722BF0D4756C4A90BACBB80892F4E2C6"><subparagraph id="H8C4547ED78574B1D892C4B391EC98AE5"><enum>(B)</enum><header>Development of requirements</header><text>Lead the development and approval, and, on a routine basis, the review and update, of requirements for such countermeasures and products, including related capabilities, to inform the advanced research, development, procurement, and replenishment decisions of the Secretary.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5933FD637B994A8498843C10312C7765"><enum>(B)</enum><text>in paragraph (4)—</text><clause commented="no" display-inline="no-display-inline" id="H3120F346C36241C9B18AFFD9866B1E70"><enum>(i)</enum><text>in subparagraph (F)—</text><subclause commented="no" display-inline="no-display-inline" id="H0F31CED936054C2BB25D6E0EB1503DE5"><enum>(I)</enum><text>in the matter preceding clause (i), by striking <quote>and in consultation with the Secretary of Homeland Security,</quote>; and</text></subclause><subclause id="HA4CB943BD9684BAE94FBDBE820E233DF"><enum>(II)</enum><text>in clause (i), by inserting <quote>enhance</quote> after <quote>capabilities and</quote>; </text></subclause></clause><clause commented="no" display-inline="no-display-inline" id="HCA22BC561F4D4FFF817780CE967C0C60"><enum>(ii)</enum><text>in subparagraph (G)—</text><subclause commented="no" display-inline="no-display-inline" id="HBFB240F0947C4A18B958276C557EF7DD"><enum>(I)</enum><text>in the matter preceding clause (i), by inserting <quote>the Office of Pandemic Preparedness and Response Policy,</quote> after <quote>Veterans Affairs,</quote>;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H5768ABE04B594B8B8CB52B282A69AE68"><enum>(II)</enum><text display-inline="yes-display-inline">in clause (i), by striking <quote>based on</quote> and inserting <quote>based on—</quote>; </text></subclause><subclause commented="no" display-inline="no-display-inline" id="H147E756385D449E8B1ABA1692F306B4E"><enum>(III)</enum><text display-inline="yes-display-inline">in clause (ii), by striking <quote>; and</quote> at the end and inserting a semicolon;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H19D8272142BF4125957DFB4CE0255E34"><enum>(IV)</enum><text>in clause (iii), by striking the period and inserting <quote>; and</quote>; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H2F1239E9B8B84C26A30EC153FA30D495"><enum>(V)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HE4D628EF38484C7A811BC93D0457929E"><clause id="H021373235760467595A69DB92AD57B77"><enum>(iv)</enum><text>that include, as appropriate, participation by relevant industry, academia, professional societies, and other stakeholders.</text></clause><after-quoted-block>; </after-quoted-block></quoted-block></subclause></clause><clause commented="no" display-inline="no-display-inline" id="H361C28286E9E4C53AC9BC5832A428C2A"><enum>(iii)</enum><text>in subparagraph (H)—</text><subclause commented="no" display-inline="no-display-inline" id="H3DA34D0F217D40BBBEE8108F2AA2C67D"><enum>(I)</enum><text>by inserting <quote>and the Director of the Office of Pandemic Preparedness and Response Policy</quote> after <quote>Security Affairs</quote>; and</text></subclause><subclause id="HD773F13FCE05440FA44B563A6F380B8F"><enum>(II)</enum><text>by inserting <quote>and medical product and supply capacity planning pursuant to subparagraph (J), including discussion of any relevant identified supply chain vulnerabilities</quote> before the period at the end; </text></subclause></clause><clause commented="no" display-inline="no-display-inline" id="H08E37CF676D24645BCBF80FCD1BDF12B"><enum>(iv)</enum><text display-inline="yes-display-inline">in subparagraph (I), by inserting <quote>the Director of the Office of Pandemic Preparedness and Response Policy,</quote> after <quote>Security Affairs,</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H7C82E4C7B3494399A151D20258388D5F"><enum>(v)</enum><text>in subparagraph (J)(i), in the matter preceding subclause (I), by inserting <quote>(including ancillary medical supplies and components of medical products, such as active pharmaceutical ingredients, key starting materials, medical device components, testing kits, reagents, and other testing supplies)</quote> after <quote>supply needs</quote>; and</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H5E9EE7C67302468B8F9A9B0ECC972236"><enum>(C)</enum><text>in paragraph (7)—</text><clause commented="no" display-inline="no-display-inline" id="H1D036EA3265C4D98B65188FB7367E119"><enum>(i)</enum><text>in the matter preceding subparagraph (A), by inserting <quote>and the requirements developed pursuant to paragraph (3)(B)</quote> after <quote>subsection (d)</quote>;</text></clause><clause commented="no" display-inline="no-display-inline" id="H6DD68092F8BC4B9BB4ABE2AC4ACAB51D"><enum>(ii)</enum><text>by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and</text></clause><clause commented="no" display-inline="no-display-inline" id="HB7402D897247471693A3F0A90E646BEE"><enum>(iii)</enum><text>by inserting after subparagraph (D) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HE3C11385A53B429C96E6F3C142983B46"><subparagraph id="HF4FE3EBB6D304DABA5687CD277B8B968"><enum>(E)</enum><text>include a professional judgment of anticipated budget needs for each future fiscal year accounted for in such plan to account for the full range of anticipated medical countermeasure needs and life-cycle costs to address such priorities and requirements;</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph></paragraph><paragraph id="H08BFD97FA647452A9672B9E6BE6C76CA"><enum>(2)</enum><text>in subsection (d)—</text><subparagraph commented="no" display-inline="no-display-inline" id="H431379E7EF4742F297D4B0147DA032D9"><enum>(A)</enum><text>by amending paragraph (1) to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H3A1F7DB56E2F4B4D95CF86F6F7FA5BCA"><paragraph id="H0890E35CD550416DAAEF1E8CFB2AE80D"><enum>(1)</enum><header>In general</header><text>Not later than March 15, 2020, and biennially thereafter, the Assistant Secretary for Preparedness and Response shall develop 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 coordinated strategy for medical countermeasures to address chemical, biological, radiological, and nuclear threats, informed by the requirements developed pursuant to subsection (b)(3)(B). Not later than 180 days after the submission of such strategy to such committees, the Assistant Secretary for Preparedness and Response shall submit an accompanying implementation plan to such committees. In developing such a strategy and plan, the Assistant Secretary for Preparedness and Response shall consult with the Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1. Such strategy and plan shall be known as the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H14C7E961A63B46479523E2D48EB14B4F"><enum>(B)</enum><text>in paragraph (2), in the matter preceding subparagraph (A), by inserting <quote>strategy and</quote> before <quote>plan</quote>; and</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H9DFBD0CBD94E499E9FBF3EFDF74D6564"><enum>(3)</enum><text>in subsection (f)—</text><subparagraph commented="no" display-inline="no-display-inline" id="H975BF8C7787649E59C3301F579C9A576"><enum>(A)</enum><text>in paragraph (1), in the matter preceding subparagraph (A), by inserting <quote>, including such agents that are an emerging infectious disease</quote> after <quote>become a pandemic</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H19333EDAA9604BFB86131D97B6E9B972"><enum>(B)</enum><text>in paragraph (2)(A), by striking <quote>$250,000,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$335,000,000 for each of fiscal years 2025 and 2026, to remain available through December 31, 2026</quote>.</text></subparagraph></paragraph></section><section id="HB90CB75F133048FCA56D4CE10C27D5EC"><enum>622.</enum><header>National Health Security Strategy</header><text display-inline="no-display-inline">Section 2802 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-1">42 U.S.C. 300hh–1</external-xref>) is amended—</text><paragraph id="HBCBA050A008A420EB01FC141CD3192D4"><enum>(1)</enum><text>in subsection (a)(3)—</text><subparagraph id="H3D3A7D8030364AD696937AD930B75976"><enum>(A)</enum><text>by striking <quote>In 2022, the</quote> and inserting <quote>The</quote>; and</text></subparagraph><subparagraph id="HFE91885A0F534AF89F81F8080BDC7C2F"><enum>(B)</enum><text>by inserting <quote>, maintaining, and sustaining</quote> after <quote>establishing</quote>; and</text></subparagraph></paragraph><paragraph id="H262FB99868D2454792A25E3F551B47FE"><enum>(2)</enum><text>in subsection (b)—</text><subparagraph id="H117D0528739949C083A47D3AD1C706E8"><enum>(A)</enum><text>in paragraph (2)—</text><clause id="H6093EB788D244DDC9A5B5190FCFA23F7"><enum>(i)</enum><text>in subparagraph (A), by inserting <quote>that support interagency coordination and availability of information, as appropriate</quote> before the period; and</text></clause><clause id="H09C88E4D950E433C90A3CEB4A6851BC4"><enum>(ii)</enum><text>in subparagraph (B), by inserting <quote>rapid testing,</quote> after <quote>and supplies,</quote>;</text></clause></subparagraph><subparagraph id="HDE4A1B19C2224E93B25D0A1177E0B7F4"><enum>(B)</enum><text>in paragraph (3)—</text><clause id="H168826D4C3E4474B9337F60E0379A3A6"><enum>(i)</enum><text>in the matter preceding subparagraph (A), by inserting <quote>and blood banks</quote> after <quote>dental health facilities</quote>;</text></clause><clause commented="no" display-inline="no-display-inline" id="HA4F73CCD3378490FB8E0738BC68E6A27"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (C), by inserting <quote>and current capacity of facilities within such systems, as applicable</quote> before the period; and</text></clause><clause id="HB716B3834EE94513A00F8DCA2062D417"><enum>(iii)</enum><text>in subparagraph (D), by inserting <quote>and other medical products and medical supplies consistent with the activities carried out under section 2811(b)(4)(J)</quote> before the period; </text></clause></subparagraph><subparagraph id="H09A7D0F116AC47659C6689CEDF8133D6"><enum>(C)</enum><text>in paragraph (5), by inserting <quote>applicable federally funded activities and</quote> after <quote>(including</quote>;</text></subparagraph><subparagraph id="H45A1812C810B4B47A24FAE33B42879E8"><enum>(D)</enum><text>in paragraph (8)—</text><clause id="HE46797A7BCD1449C9EF5E0EBDB6123BB"><enum>(i)</enum><text>in subparagraph (A), by inserting <quote>public health and medical</quote> before <quote>activities</quote>; and</text></clause><clause id="HA989AA3560764E55BDD9806E9CA2A8A8"><enum>(ii)</enum><text>in subparagraph (B), by striking <quote>familiarity with</quote> and inserting <quote>understanding of, and coordination between,</quote>;</text></clause></subparagraph><subparagraph id="HE3EE514E847C468AB6FA526CA9BA3F4A"><enum>(E)</enum><text>by redesignating paragraphs (9) and (10) as paragraphs (10) and (12), respectively;</text></subparagraph><subparagraph id="H80C79700C1094C3DAD14704DBB60942C"><enum>(F)</enum><text>by inserting after paragraph (8) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H2D046446D52A4A7D8DE09EC3EB5F4EF2"><paragraph id="H8B95824754E7411F8084DE76FE968C6E"><enum>(9)</enum><header>Other settings</header><text>Supporting Federal, State, local, and Tribal coordination and planning with respect to facilities in which there is an increased risk of infectious disease outbreaks, including such facilities that address the needs of at-risk individuals, in the event of a public health emergency declared under section 319.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="HFFB349CFB8CB44ED98687A05814B5D85"><enum>(G)</enum><text>by inserting after subparagraph (10), as so redesignated, the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H7E1E336168EF435BB7F134437F2867E7"><paragraph id="H610CD520E9FF42A6848D191FD2354B5F"><enum>(11)</enum><header>Other hazards</header><text>Assessing current and potential health security threats from natural disasters with respect to public health and medical preparedness and response.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="H92A7DF287B754542A2C0FA6734DDD276"><enum>(H)</enum><text>by inserting after paragraph (12), as so redesignated, the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H863E9B58B0A14D13BA8F31BFB1F70134"><paragraph id="HEEF3029EAD33404EB0D4B40AEA148109"><enum>(13)</enum><header>Cybersecurity resiliency of health care systems</header><text>Consistent with the requirements of section 2218 of the Homeland Security Act of 2002, strengthening the ability of States, local communities, and Tribal communities to prepare for, respond to, and be resilient against cybersecurity vulnerabilities or cybersecurity attacks that affect public health and health information technology, and encouraging health care facilities to use recognized security practices meeting or exceeding the approaches established under section 405(d) of the Cybersecurity Act of 2015.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph id="H69AD06931D10484284BB8DFCA3E82D16"><enum>(I)</enum><text>by striking <quote>tribal</quote> each place it appears and inserting <quote>Tribal</quote>. </text></subparagraph></paragraph></section><section id="H21AA8EB604254034921C114FD4CC528B"><enum>623.</enum><header>Improving development and distribution of diagnostic tests</header><text display-inline="no-display-inline">Section 319B of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-2">42 U.S.C. 247d–2</external-xref>) is amended to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HB2BB9AB47689403CBBF7E1F363CD91F7"><section id="HA3698EDA22294BC4BF73D078D991901C"><enum>319B.</enum><header>Improving development and distribution of diagnostic tests</header><subsection id="HFD7A9FDE83EC476B952ABA372BF0BEC9"><enum>(a)</enum><header>Diagnostic testing preparedness plan</header><text>The Secretary shall develop, make publicly available, not later than 1 year after the date of enactment of the Pandemic and All-Hazards Preparedness and Response Act, and update not less frequently than every 3 years thereafter, a plan for the rapid development, validation, authorization, manufacture, procurement, and distribution of diagnostic tests, and for rapid scaling of testing capacity, in response to chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, for which a public health emergency is declared under section 319, or that has significant potential to cause such a public health emergency.</text></subsection><subsection id="H18CD1FC9117D40179BBE3A8D112C6943"><enum>(b)</enum><header>Purposes</header><text>The purpose of the plan under subsection (a) shall be to—</text><paragraph id="HF781609764AF41638C04217F00315A0D"><enum>(1)</enum><text>facilitate the development and utilization of diagnostic tests;</text></paragraph><paragraph id="H0DABBC711F9F40EC9825615A0464D8A1"><enum>(2)</enum><text>describe the processes for the rapid development, validation, authorization, manufacture, procurement, and distribution of diagnostic tests, and for rapid scaling of testing capacity; and</text></paragraph><paragraph id="H14E36BCA89CD4622BECB73156DA9BC5C"><enum>(3)</enum><text>facilitate coordination and collaboration among public and private entities to improve the rapid development and utilization of diagnostic testing during a public health emergency.</text></paragraph></subsection><subsection id="H1973EAA7E2EC489FB9C9C3CEA6112A90"><enum>(c)</enum><header>Considerations</header><text>The plan under subsection (a) shall take into consideration—</text><paragraph id="H94213B9B2EBB48CBB50A95F87C7F266D"><enum>(1)</enum><text>domestic capacity, including any such capacity established through partnerships with public and private entities pursuant to subsection (e), to support the development, validation, manufacture, procurement, and distribution of tests, and the rapid scaling of testing capacity;</text></paragraph><paragraph id="HEC52F0CF6E974BDFAC11A0CB418022AB"><enum>(2)</enum><text>novel technologies and platforms that—</text><subparagraph id="HD1F8272F18584640B7BA7884EED8EEA4"><enum>(A)</enum><text>may be used to improve testing capabilities, including—</text><clause id="H14A69B2D41CA466B84D5CF1872B359A9"><enum>(i)</enum><text>high-throughput laboratory diagnostics;</text></clause><clause id="HE7688B70716B4C649560AD614DBAEE7D"><enum>(ii)</enum><text>point-of-care diagnostics; and</text></clause><clause id="H0182B07A91CE4DBD9CBE6DA5C24EA6FC"><enum>(iii)</enum><text>rapid at-home diagnostics;</text></clause></subparagraph><subparagraph id="H1254D5CBC6BE414ABBB8055BB33E11B6"><enum>(B)</enum><text>improve the accessibility of diagnostic tests; and</text></subparagraph><subparagraph id="H3E34B52ED9BA45E791DCBD91EEACCF24"><enum>(C)</enum><text>facilitate the development and manufacture of diagnostic tests;</text></subparagraph></paragraph><paragraph id="H0E1D2115B26D40D4ADC0D6AB6B9E67ED"><enum>(3)</enum><text>medical supply needs related to testing, including diagnostic testing, equipment, supplies, and component parts, and any potential vulnerabilities related to the availability of such medical supplies and related planning needs, consistent with section 2811(b)(4)(J);</text></paragraph><paragraph id="H1C874FE7BCD74B8D9A0A4F5DE3C5EF41"><enum>(4)</enum><text>strategies for the rapid and efficient distribution of tests locally, regionally, or nationwide and appropriate scaling of laboratory testing capacity; and</text></paragraph><paragraph id="H8362087F08B04A6D8A2E2B6C2E129BFB"><enum>(5)</enum><text>assessment of such strategies through drills and operational exercises carried out under section 2811(b)(4)(G), as appropriate.</text></paragraph></subsection><subsection id="HDA4DECB567714A0BBFC7B19A007B8A0F"><enum>(d)</enum><header>Coordination</header><text>To inform the development and update of the plan under subsection (a), and in carrying out activities to implement such plan, the Secretary shall coordinate with industry, such as device manufacturers, clinical and reference laboratories, and medical product distributors, States, local governmental entities, Indian Tribes and Tribal organizations, and other relevant public and private entities.</text></subsection><subsection id="H31A18E3897374DA7972241D0B4E71457"><enum>(e)</enum><header>Capacity building</header><text>The Secretary may contract with public and private entities, as appropriate, to increase domestic capacity in the rapid development, validation, authorization, manufacture, procurement, and distribution of diagnostic tests, as appropriate, to State, local, and Tribal health departments and other appropriate entities for immediate public health response activities to address an infectious disease with respect to which a public health emergency is declared under section 319, or that has significant potential to cause such a public health emergency.</text></subsection></section><after-quoted-block>. </after-quoted-block></quoted-block></section><section id="H2CFAE192BEF4486FB0394CCA6F97C57B"><enum>624.</enum><header>Combating antimicrobial resistance</header><subsection commented="no" display-inline="no-display-inline" id="HEE7D4A09115148B4A78BF6431D0D3DD9"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 319E of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-5">42 U.S.C. 247d–5</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H05D9006740CF400D98B164FABD6C8E99"><enum>(1)</enum><text>in subsection (a)—</text><subparagraph commented="no" display-inline="no-display-inline" id="HB9581FDBBB08459E816BCDC594356894"><enum>(A)</enum><text>in paragraph (1), by inserting <quote>and activities</quote> after <quote>Federal programs</quote>;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H60E84748274E4EC39320062E0ED6149B"><enum>(B)</enum><text>in paragraph (2)—</text><clause commented="no" display-inline="no-display-inline" id="H4A8D840237C4401EAE814BD20C33917A"><enum>(i)</enum><text>by striking <quote>public health constituencies, manufacturers, veterinary and medical professional societies and others</quote> and inserting <quote>the Advisory Council described in subsection (b) and relevant public and private entities</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="HD54DDE5340A140BEA2587C7833B70393"><enum>(ii)</enum><text>by inserting <quote>, pursuant to paragraph (4),</quote> after <quote>comprehensive plan</quote>;</text></clause></subparagraph><subparagraph id="H0F16B64E0EA84701899248B8F407DCC5"><enum>(C)</enum><text>by amending paragraph (3) to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H509EB21D99584924ACED4720459D8835"><paragraph id="HB372C2343D0442BFA46237FF5F66813B"><enum>(3)</enum><header>Agenda</header><text>The task force described in paragraph (1) shall consider factors the Secretary considers appropriate, including factors to—</text><subparagraph id="H6180FD8BB429434DAB7E1907B5BED82C"><enum>(A)</enum><text>slow the emergence of resistant bacteria and fungi and prevent the spread of resistant infections;</text></subparagraph><subparagraph id="HD06E1629EC9542DA8030B4FAA9AF46DF"><enum>(B)</enum><text>strengthen activities to combat resistance with respect to zoonotic diseases;</text></subparagraph><subparagraph id="HCEC102381B5A4D119BF7CD9A5F625B6B"><enum>(C)</enum><text>advance development and use of rapid and innovative capabilities, including diagnostic tests, for identification and characterization of resistant bacteria and fungi;</text></subparagraph><subparagraph id="H6C0D089C6A4A46EF9C2D2DF312CB2D81"><enum>(D)</enum><text>accelerate basic and applied research and development for new antibiotics, antifungals, and other related therapeutics and vaccines; and</text></subparagraph><subparagraph id="H1178D6C5ED84408C8CAF8F69A25F38FF"><enum>(E)</enum><text>support international collaboration and capacities for antimicrobial-resistance prevention, detection, and control.</text></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H620E5DAEC79C447690FF71C0A2D0B02F"><enum>(D)</enum><text>by redesignating paragraph (4) as paragraph (5); and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H3127A07D979542049B57CD5E1ECCCC9B"><enum>(E)</enum><text>by inserting after paragraph (3) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H47F8CFAAFDF645AA89F2370C44AE2F7E"><paragraph id="H4CAD93F039594998B21BCFD7DDC20FED" commented="no"><enum>(4)</enum><header>Action plan</header><text>Not later than October 1, 2026, and every 5 years thereafter, the task force described in paragraph (1) shall develop and submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a plan regarding Federal programs and activities to combat antimicrobial resistance, including measurable outcomes, as appropriate, informed by—</text><subparagraph commented="no" display-inline="no-display-inline" id="HE12B92BD98A040F8AF6D17241F2FDF1D"><enum>(A)</enum><text display-inline="yes-display-inline">the agenda described in paragraph (3);</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H4378C9F3E10F4F7991A3183E668C65E4"><enum>(B)</enum><text display-inline="yes-display-inline">input provided by the Advisory Council described in subsection (b); and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H60DE42D4CB1D4B60B348BEB581E0B8EC"><enum>(C)</enum><text display-inline="yes-display-inline">input from other relevant stakeholders provided pursuant to paragraph (2).</text></subparagraph></paragraph><after-quoted-block>; </after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HEBFBBEBE3E23445EA6242D695BE2B5AA"><enum>(2)</enum><text>by redesignating subsections (b) through (o) as subsections (c) through (p), respectively;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H79A7611F36D8445EB065EEB5A4A44906"><enum>(3)</enum><text>by inserting after subsection (a) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H8A3B912750BD4DFA80695743095A6B37"><subsection commented="no" display-inline="no-display-inline" id="H0886605C1AEF43BCB32FA2C2F666D98B"><enum>(b)</enum><header>Advisory council</header><paragraph commented="no" display-inline="no-display-inline" id="H81CC1F3540A0465C8EFAA9AC7DEE0CC8"><enum>(1)</enum><header>In general</header><text>The Secretary may continue the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, referred to in this subsection as the <quote>Advisory Council</quote>.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H13879FB0729F460C8D2A518F86114A19"><enum>(2)</enum><header>Duties</header><text>The Advisory Council shall advise and provide information and recommendations to the Secretary, acting through the Task Force established under subsection (a), regarding Federal programs and activities intended to reduce or combat antimicrobial-resistant bacteria or fungi that may present a public health threat and improve capabilities to prevent, diagnose, mitigate, or treat such resistance. Such advice, information, and recommendations may be related to improving Federal efforts related to factors described in subsection (a)(3) and other topics related to antimicrobial resistance, as appropriate.</text></paragraph><paragraph id="H8F090B9E259342B19D6D4CD803DDE498"><enum>(3)</enum><header>Meetings and coordination</header><subparagraph id="H9EF1CEC4000C4CF68C9B632D3447A069"><enum>(A)</enum><header>Meetings</header><text>The Advisory Council shall meet not less frequently than biannually and, to the extent practicable, in coordination with meetings of the task force established under subsection (a).</text></subparagraph><subparagraph id="HB0A93EE1BFD24A1EBD032891D5E057F8"><enum>(B)</enum><header>Coordination</header><text>The Advisory Council shall, to the greatest extent practicable, coordinate activities carried out by the Council with the task force established under subsection (a).</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3190E7F9A7BD40059E3CC0FDBF5B55DD"><enum>(4)</enum><header>FACA</header><text><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/10">Chapter 10</external-xref> of title 5, United States Code, shall apply to the activities and duties of the Advisory Council.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H1082D90D5D9B4491945E775AFB613C27"><enum>(5)</enum><header>Sunset</header><subparagraph commented="no" display-inline="no-display-inline" id="H7E448D4A968A48D09BEB253DAE95E691"><enum>(A)</enum><header>In general</header><text>The Advisory Council under this subsection shall terminate on December 31, 2026.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HA6B3F0A7158E494DA0B837BF7D3D0A8B"><enum>(B)</enum><header>Extension of Advisory Council</header><text display-inline="yes-display-inline">Not later than October 1, 2026, the Secretary shall 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 includes a recommendation on whether the Advisory Council should be extended, and identifying whether there are other committees, councils, or task forces that have overlapping or similar duties to that of the Advisory Council, and whether such committees, councils, or task forces should be combined, restructured, or eliminated, including with respect to the task force established under subsection (a).</text></subparagraph></paragraph></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H66E962F9082A492783BB54C26625E9F6"><enum>(4)</enum><text>in subsection (n), as so redesignated, by striking <quote>(f) through (j)</quote> and inserting <quote>(g) through (k)</quote>.</text></paragraph></subsection><subsection id="H4D14D114DB3749BB8550B7A59ACE59FB"><enum>(b)</enum><header>Conforming amendment</header><text>Section 505 of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-5">42 U.S.C. 247d–5</external-xref> note; <external-xref legal-doc="public-law" parsable-cite="pl/116/22">Public Law 116–22</external-xref>) is amended by striking subsection (a) and all that follows through <quote>Not later</quote> in subsection (e) and inserting the following: </text><quoted-block style="OLC" display-inline="no-display-inline" id="H3D1FFF5ED96243848B4D47EE4EC30941"><section display-inline="yes-display-inline" section-type="undesignated-section" id="HDB6A5A19ADB74DD4A9271C4899A787CC"><text display-inline="no-display-inline">Not later</text></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section id="H9A02D5B481FE4747ADAE0C5A305D8F9B"><enum>625.</enum><header>Strategic National Stockpile and material threats</header><text display-inline="no-display-inline">Section 319F–2 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6b">42 U.S.C. 247d–6b</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="HBF89221879A04E1F8C74F4E0A0CBB3BD"><enum>(1)</enum><text>in subsection (a)—</text><subparagraph id="H1F7EF9B189984CC4BF2CF18534DB3B93"><enum>(A)</enum><text>in paragraph (2)—</text><clause commented="no" display-inline="no-display-inline" id="H056E0EC8D8DB4CC3A4EBB91D0B44F7B5"><enum>(i)</enum><text display-inline="yes-display-inline">in subparagraph (A), by inserting <quote>Such review shall include a description of how the Secretary manages and mitigates risks associated with gaps between current inventory levels and stockpiling goals, prioritizes such risks, and tracks progress toward mitigation of such risks.</quote> after the first sentence; and </text></clause><clause commented="no" display-inline="no-display-inline" id="HDC7B758791FE48CDBE2926250B45763F"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (B)(i), by amending subclause (IV) to read as follows: </text><quoted-block style="OLC" display-inline="no-display-inline" id="H80F4EEC7811145878E3122B9882F8485"><subclause id="H1E80BFB2787847EBB4F661AAC78C34BF"><enum>(IV)</enum><text>the emergency health security threat or threats such countermeasure procurement is intended to address, including—</text><item id="H1B0A267D90AA4D19BB17EF9477E189AB"><enum>(aa)</enum><text>whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats; and</text></item><item id="HDD7C84D55C3B489EB3055156DB89001D"><enum>(bb)</enum><text>in the case of a countermeasure that addresses a biological agent, whether such agent has an increased likelihood to become resistant to, more resistant to, or evade, such countermeasure relative to other available medical countermeasures;</text></item></subclause><after-quoted-block>; </after-quoted-block></quoted-block></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HB63DDECFB2BC441ABEB7B4F2CA37CD17"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (3)—</text><clause commented="no" display-inline="no-display-inline" id="HA157E8C6176A4054B36A930D2682C19C"><enum>(i)</enum><text>in subparagraph (B), by striking <quote>are followed, regularly reviewed, and updated with respect to such stockpile</quote> and inserting <quote>with respect to such stockpile are followed, regularly reviewed, and updated to reflect best practices</quote>;</text></clause><clause id="H6A7DDCBB234547D0AAAC6E5B89A6698D"><enum>(ii)</enum><text>in subparagraph (I), by inserting <quote>, through a standard operating procedure,</quote> after <quote>ensure</quote>;</text></clause><clause commented="no" display-inline="no-display-inline" id="H47ED059C7A61444DB87D72DC9B6AFB1B"><enum>(iii)</enum><text display-inline="yes-display-inline">by redesignating subparagraphs (H) through (K) as subparagraphs (I) through (L), respectively; </text></clause><clause commented="no" display-inline="no-display-inline" id="H2314020A0F4741D19C4CAC0292D9224C"><enum>(iv)</enum><text>by inserting after subparagraph (G) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H7DBB1FD0AD3749958B1DCF0CAB7545B5"><subparagraph id="H9263E999E4C746BCAB7A2DE8E1715CFA"><enum>(H)</enum><text>utilize tools to enable the timely and accurate tracking of the contents of the stockpile throughout the deployment of such contents, including tracking of the location and geographic distribution and utilization of such contents;</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause><clause commented="no" display-inline="no-display-inline" id="H800985B4004445AEB6B1836BB30FC9F6"><enum>(v)</enum><text>in subparagraph (K), as so redesignated, by striking <quote>; and</quote> at the end and inserting a semicolon;</text></clause><clause commented="no" display-inline="no-display-inline" id="H79C3F7EF82F244858D8807A8D3914812"><enum>(vi)</enum><text>in subparagraph (L), as so redesignated, by striking the period and inserting <quote>; and</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H610D4A3E0E004770A260B26BEC02642A"><enum>(vii)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H87A9E3E3FF504C7AB677B3AAEDE84206"><subparagraph id="H3BC3ADF29CEC483192115C5909A50FA4"><enum>(M)</enum><text>communicate to relevant vendors regarding modifications, renewals, extensions, or terminations of contracts, or the intent to exercise options for such contracts, within 30 days, as practicable, of such determination, including through the development of a contract notification process.</text></subparagraph><after-quoted-block>; </after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="H90A36767EB1B473DA384B640BB6C5C87"><enum>(C)</enum><text>in paragraph (5)(B), in the matter preceding clause (i), by inserting <quote>, which may accompany the review required under paragraph (2),</quote> after <quote>Representatives a report</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H40D32CD3299243F49085E0DFB6DC6A10"><enum>(D)</enum><text>in paragraph (6)(A)—</text><clause commented="no" display-inline="no-display-inline" id="H9BB35004A6874A27BB007EA31D2683B9"><enum>(i)</enum><text display-inline="yes-display-inline">by redesignating clauses (viii) through (x) as clauses (ix) through (xi), respectively; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H06967724F4924AD096F39872E5AD30F6"><enum>(ii)</enum><text>by inserting after clause (vii) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H6B1047991C7240C9B439F982695752A1"><clause id="H0B66FBAE45244BCA9152F47D1308CA77"><enum>(viii)</enum><text>with respect to any change in the Federal organizational management of the stockpile, an assessment and comparison of any differences in the processes and operations resulting from such change, including—</text><subclause commented="no" display-inline="no-display-inline" id="HE6EC8277F7A245789DB6B79873EF3338"><enum>(I)</enum><text display-inline="yes-display-inline">planning for potential countermeasure deployment, distribution, or dispensing capabilities;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HC418C7D0C22C41EA8554212069891610"><enum>(II)</enum><text display-inline="yes-display-inline">organizational structure;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HECCFF88CC8714EAD8D3A8A6C7D5B3F26"><enum>(III)</enum><text display-inline="yes-display-inline">communication with relevant stakeholders related to procurement decisions;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HDBD12BC4EF1449E7B1907C1BCCF41053"><enum>(IV)</enum><text display-inline="yes-display-inline">processes related to procurement, deployment, and use of stockpiled countermeasures;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H28BD5A86A9EE4AD8B733185D30C43B8B"><enum>(V)</enum><text display-inline="yes-display-inline">communication and coordination with the Public Health Emergency Medical Countermeasures Enterprise and other related Federal entities;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H69187D26B8B348A1B89122814646237E"><enum>(VI)</enum><text display-inline="yes-display-inline">inventory management; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H380C4B39EC66405EB16DC5B786666C25"><enum>(VII)</enum><text display-inline="yes-display-inline">availability and use of resources for such activities;</text></subclause></clause><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0336C08EA51F466C9DC61D36DD9DEE50"><enum>(2)</enum><text>in subsection (c)(2)(C), by striking <quote>promptly</quote> and inserting <quote>, not later than 60 days after each such determination,</quote>;</text></paragraph><paragraph id="H102907FA4F0F4E98857D7F92FCC99C13" commented="no"><enum>(3)</enum><text>in subsection (f)(1), by striking <quote>$610,000,000 for each of fiscal years 2019 through 2021, and $750,000,000 for each of fiscal years 2022 and 2023</quote> and inserting <quote>$1,100,000,000 for fiscal year 2025, and $1,210,000,000 for fiscal year 2026</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2D9351DC8E244CC698C120BE2B3A1CB2"><enum>(4)</enum><text>in subsection (g)(1), by striking <quote>2019 through 2028</quote> and inserting <quote>2025 through 2034</quote>.</text></paragraph></section><section id="H32392C29035F4C7291027B2762D0E172"><enum>626.</enum><header>Medical countermeasures for viral threats with pandemic potential</header><text display-inline="no-display-inline">Section 319L of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-7e">42 U.S.C. 247d–7e</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H9F0CCFC3570142ABB75694DD22F2D056"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (c)—</text><subparagraph commented="no" display-inline="no-display-inline" id="H019535C9CC0D43E58C021C61C5FE1F97"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text><clause commented="no" display-inline="no-display-inline" id="HE039F1310EC54A30B8C097C3528D2075"><enum>(i)</enum><text display-inline="yes-display-inline">in subparagraph (D)—</text><subclause commented="no" display-inline="no-display-inline" id="H675805E39C3A4DA5B3E476617F2C732A"><enum>(I)</enum><text display-inline="yes-display-inline">in clause (ii), by striking <quote>; and</quote> and inserting a semicolon;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H7C0E503497C64A128B5F6058A9A6A2EC"><enum>(II)</enum><text>by redesignating clause (iii) as clause (iv); and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HE89CA421BC8248AAA521DDBDC6E8A7C6"><enum>(III)</enum><text>by inserting after clause (ii) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HCE419E4271064586B65D8339834B4514"><clause id="H75DCF7B4639F40D78816191598644EEE"><enum>(iii)</enum><text>research and development of medical countermeasures for priority virus families that have significant potential to cause a pandemic, including such countermeasures that take either pathogen-specific or pathogen-agnostic approaches, and platform technologies to improve the development and manufacture of such medical countermeasures; and</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></subclause></clause><clause commented="no" display-inline="no-display-inline" id="HF415004635164282A83B5C62B22AF37D"><enum>(ii)</enum><text>in subparagraph (F)(ii), by inserting <quote>or priority virus families and other viral pathogens that pose a threat due to their significant potential to cause a pandemic,</quote> after <quote>pandemic influenza,</quote>; and</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H00C4EB526F3E4AFAB884FB37AFA613AB"><enum>(B)</enum><text>in paragraph (5), by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H2BD41D545E694C9987EC2BE1EE47D994"><subparagraph id="HD2A6ABAB7903449196A5760220821B1B"><enum>(I)</enum><header>Notification</header><text>In awarding contracts, grants, cooperative agreements, or other transactions under this section, the Secretary shall communicate to relevant vendors regarding modifications, renewals, extensions, or terminations of contracts, including through the development of a contract notification process, within 30 days of such determination, as practicable.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC471D05B1EE04EA6840A0978F8BE4246"><enum>(2)</enum><text>in subsection (d)(2), by striking <quote>$611,700,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$950,000,000 for each of fiscal years 2025 and 2026</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H2AD6262687BF41BBA83AFDD0F86D5464"><enum>(3)</enum><text>in subsection (e)(1), by amending subparagraph (D) to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H15AC9ED2D60C48898BA87743C3C624A2"><subparagraph id="HF022ECE218A549BD8753C731FADDE726" commented="no"><enum>(D)</enum><header>Sunset</header><text>This paragraph shall cease to have force or effect after December 31, 2026.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="H70D4D6F217004E2692EDE0CC568DC2D4"><enum>627.</enum><header>Public Health Emergency Medical Countermeasures Enterprise</header><text display-inline="no-display-inline">Section 2811–1 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10a">42 U.S.C. 300hh–10a</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H28E5400CF0034C1085B926F350D6C44C"><enum>(1)</enum><text>in subsection (b)—</text><subparagraph commented="no" display-inline="no-display-inline" id="H04A22EE3E0B74849A135FACAAD37CA17"><enum>(A)</enum><text display-inline="yes-display-inline">by redesignating paragraph (11) as paragraph (13);</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HCD9431D243D44384A5CDAFD509E27788"><enum>(B)</enum><text>by inserting after paragraph (10) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H860DE7088FBF4C6B8ECC8C506B8EE295"><paragraph commented="no" display-inline="no-display-inline" id="H643F07E450AC473EB9A0232DF60D0934"><enum>(11)</enum><text>The Director of the Biomedical Advanced Research and Development Authority.</text></paragraph><paragraph id="HCD8F65212C894DF5B0C53675C0A66141"><enum>(12)</enum><text>The Director of the Strategic National Stockpile.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H37F1061467E841868283FD133CDF25C0"><enum>(C)</enum><text>in paragraph (13), as so redesignated, by striking <quote>the Director of the Biomedical Advanced Research and Development Authority, the Director of the Strategic National Stockpile, the Director of the National Institute of Allergy and Infectious Diseases,</quote> and inserting <quote>the Director of the National Institute of Allergy and Infectious Diseases</quote>; and</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H6B1C62B802784DCDAEE4C26A0C79D8CD"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (c)—</text><subparagraph commented="no" display-inline="no-display-inline" id="H27E351652E0D426A928962852D666E75"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text><clause commented="no" display-inline="no-display-inline" id="HF169CBA6F9D548EC8E753E655224D1D2"><enum>(i)</enum><text display-inline="yes-display-inline">by redesignating subparagraph (D) as subparagraph (E); and</text></clause><clause commented="no" display-inline="no-display-inline" id="HC95F884C49EA4499928809755058795A"><enum>(ii)</enum><text>by inserting after subparagraph (C) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H8B75B4817F434472935C1C56FA18D71D"><subparagraph id="H809875931EBE45D9984A04C7BD8A53CC"><enum>(D)</enum><text>Assist the Secretary in developing strategies for appropriate and evidence-based allocation and distribution of countermeasures to jurisdictions, in a manner that supports the availability and use of such countermeasures, for public health and medical preparedness and response needs.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HECB078A1FB704FDEB19EED0CEB942535"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2), by inserting <quote>relevant stakeholders, including industry,</quote> after <quote>consider input from</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H071C843AF02E4AC9BDF49328DAEEFA1D"><enum>(C)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HB27D56A3A08C40E6A2CC9D566365B667"><paragraph id="H92D7EDB7473749BF9A1BDE21364A797D"><enum>(3)</enum><header>Information sharing</header><text>The Secretary shall, as appropriate and in a manner that does not compromise national security, communicate and share information related to recommendations made and strategies developed under paragraph (1) with relevant stakeholders, including industry and State, local, and Tribal public health departments.</text></paragraph><after-quoted-block>. </after-quoted-block></quoted-block></subparagraph></paragraph></section><section id="HBBE28E30510A43FDB4D9ACFDF89F98FD"><enum>628.</enum><header>Fellowship and training programs</header><text display-inline="no-display-inline">Section 317G of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-8">42 U.S.C. 247b–8</external-xref>) is amended—</text><paragraph id="HF7175383C415408F8C4E2C325D0AC994"><enum>(1)</enum><text>by striking <quote>The Secretary,</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H15EEA756941247EAB07AA90CBE3599CD"><subsection id="H26880C9B173446D3A41CCA3A6B672CD3"><enum>(a)</enum><header>In general</header><text>The Secretary,</text></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="H6C8D4A128FE84907A59C4AC1F1D17948"><enum>(2)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H50FA005D4E544AB4A441311090D73C6F"><subsection id="H4625024CF2344D48B57123FEE7F0C6E5"><enum>(b)</enum><header>Noncompetitive conversion</header><paragraph id="HA668A3BF9FF14C8286D7AE4C6336B5BA"><enum>(1)</enum><header>In general</header><text>The Secretary may noncompetitively convert an individual who has completed an epidemiology, surveillance, or laboratory fellowship or training program under subsection (a) to a career-conditional appointment without regard to the provisions of subchapter I of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/33">chapter 33</external-xref> of title 5, United States Code, provided that such individual meets qualification requirements for the appointment.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="HC1272D864856414D8A6EBACFD2A877F1"><enum>629.</enum><header>Regional biocontainment research laboratories</header><subsection id="H65D9409D1B2E47AFB2B2F3EE882145A9"><enum>(a)</enum><header>In general</header><text>The Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) shall make awards to establish or maintain, as applicable, not fewer than 12 regional biocontainment laboratories, for purposes of—</text><paragraph commented="no" display-inline="no-display-inline" id="H8EEAE90A93CE40879591D386FBA21F25"><enum>(1)</enum><text display-inline="yes-display-inline">conducting biomedical research to support public health and medical preparedness for, and rapid response to, biological agents, including emerging infectious diseases;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HC6E62152259C490C97481FD58ED3F374"><enum>(2)</enum><text display-inline="yes-display-inline">ensuring the availability of surge capacity for purposes of responding to such biological agents;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HAD25740A896C40939AA53E965B659E0A"><enum>(3)</enum><text display-inline="yes-display-inline">supporting information sharing between, and the dissemination of findings to, researchers and other relevant individuals to facilitate collaboration between industry and academia; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD4FAB4BAB07142C78D9ADAC8C731F756"><enum>(4)</enum><text display-inline="yes-display-inline">providing, as appropriate and applicable, technical assistance and training to researchers and other relevant individuals to support the biomedical research workforce in improving the management and mitigation of safety and security risks in the conduct of research involving such biological agents.</text></paragraph></subsection><subsection id="H5EA8E236001E405FB6A419889D92E1F3"><enum>(b)</enum><header>Requirements</header><text display-inline="yes-display-inline">As a condition of receiving a grant under this section, a regional biocontainment laboratory shall agree to such oversight activities as the Secretary determines appropriate, including periodic meetings with relevant officials of the Department of Health and Human Services, facility inspections, and other activities as necessary and appropriate to ensure compliance with the terms and conditions of such award.</text></subsection><subsection id="HD4B59789B4564730B06B3EBBFBB9594F"><enum>(c)</enum><header>Working group</header><text>The Secretary shall establish a Working Group, consisting of a representative from each entity in receipt of an award under subsection (a). The Working Group shall make recommendations to the Secretary in administering awards under this section, for purposes of—</text><paragraph id="H5BE7C6027EC74ACB9AFC00DFADBCE890"><enum>(1)</enum><text>improving the quality and consistency of applicable procedures and practices within laboratories funded pursuant to subsection (a); and</text></paragraph><paragraph id="HB0B2B2FE9FE545BF8A03B0BDF086F8BE"><enum>(2)</enum><text>ensuring coordination, as appropriate, of federally funded activities carried out at such laboratories. </text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HFD06B3BAD3244DBD84ACAAF11A23CBC9"><enum>(d)</enum><header display-inline="yes-display-inline">Definition</header><text>In this section, the term <term>regional biocontainment laboratory</term> means a Biosafety or Animal Biosafety Level–3 and Level–2 facility located at an institution in the United States that is designated by the Secretary to carry out the activities described in subsection (a).</text></subsection><subsection commented="no" display-inline="no-display-inline" id="HF641AA4898524AFCB20F88296BB2DE9A"><enum>(e)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">To carry out this section, there are authorized to be appropriated $52,000,000 for each of fiscal years 2025 and 2026, to remain available through December 31, 2026.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="HEC02FE06F6834B8DA30CA3F38A6BB780"><enum>(f)</enum><header>Administrative expenses</header><text>Of the amount available to carry out this section for a fiscal year, the Secretary may use not more than 5 percent for the administrative expenses of carrying out this section, including expenses related to carrying out subsection (c).</text></subsection><subsection id="HE16A8CDB5D61495ABBE1D1221D29FFE7"><enum>(g)</enum><header>Report to Congress</header><text display-inline="yes-display-inline">Not later than 1 year after the date of the enactment of this Act, and biannually thereafter, the Secretary, in consultation with the heads of applicable Federal departments and agencies shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on—</text><paragraph id="H6D26BB7057994B0CAC7451CCA502C3EB"><enum>(1)</enum><text>the activities and accomplishments of the regional biocontainment laboratories;</text></paragraph><paragraph id="HA35F2B6E1E3E49EE9A316446C931247B"><enum>(2)</enum><text>any published or disseminated research findings based on research conducted in such laboratories in the applicable year;</text></paragraph><paragraph id="H3552DECD60B244BB82D3A1DA729A0514"><enum>(3)</enum><text>oversight activities carried out by the Secretary pursuant to subsection (b);</text></paragraph><paragraph id="H463F5D37AAC741CAA54DBEC0669C6463"><enum>(4)</enum><text>activities undertaken by the Secretary to take into consideration the capacity and capabilities of the network of regional biocontainment laboratories in activities to prepare for and respond to biological agents, which may include leveraging such capacity and capabilities to support the Laboratory Response Network, as applicable and appropriate;</text></paragraph><paragraph id="H187E386DB11746619635F271B9B945F2"><enum>(5)</enum><text>plans for the maintenance and sustainment of federally funded activities conducted at the regional biocontainment laboratories, consistent with the strategy required under section 2312 of the PREVENT Pandemics Act (<external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref>); and</text></paragraph><paragraph id="H2302A88646EF422A9D58AEFF763A8606" commented="no" display-inline="no-display-inline"><enum>(6)</enum><text>activities undertaken by the Secretary to coordinate with the heads of other relevant Federal departments and agencies to ensure that work carried out by each such facility on behalf of the Secretary and such other relevant heads is prioritized, is complementary to the work carried out by other such facilities and other relevant federally funded activities, and avoids unnecessary duplication. </text></paragraph></subsection></section><section id="H9D3CDD81E9F4490E8817D50E5883B2C3" commented="no"><enum>629A.</enum><header>Limitation related to countries of concern conducting certain research</header><text display-inline="no-display-inline">Section 2315(c) of the PREVENT Pandemics Act (<external-xref legal-doc="usc" parsable-cite="usc/42/6627">42 U.S.C. 6627</external-xref>) is amended to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HDB1A257EB44B44FFAC5A54DF653010C3"><subsection id="H739BE78E236F41A6A290C4786A45FDBB"><enum>(c)</enum><header>Limitations on countries of concern conducting certain research</header><paragraph id="H1A613A1718824DD68B034778B3E103CE"><enum>(1)</enum><header>In general</header><text>The Secretary of Health and Human Services (referred to in this subsection as the <quote>Secretary</quote>) shall not fund research that may reasonably be anticipated to involve the creation, transfer, and use of enhanced pathogens of pandemic potential or biological agents or toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act if such research is conducted by a foreign entity at a facility located in a country that is determined to be a country of concern as defined in paragraph (2).</text></paragraph><paragraph id="H23C5B846CE27401E978ED89551A368D7"><enum>(2)</enum><header>Countries of concern</header><subparagraph id="H5CADA43A387B44378739C7597235B6CD"><enum>(A)</enum><header>Definition</header><text>For purposes of this subsection, a <term>country of concern</term> means the People’s Republic of China, the Democratic People’s Republic of Korea, the Russian Federation, the Islamic Republic of Iran, and any other country as determined pursuant to subparagraph (B).</text></subparagraph><subparagraph id="H16228218039A45DC89899A9B610C7676"><enum>(B)</enum><header>Additional countries</header><text>The Director of National Intelligence (referred to in this subsection as the <quote>Director</quote>) shall, in consultation with the Secretary, add additional countries of concern for purposes of paragraph (1), only if—</text><clause id="HB5120DBBE7FD40B78126BB4E717EA352"><enum>(i)</enum><text>the Director determines that evidence exists that a country has malicious intent related to the creation, enhancement, transfer, or use of pathogens of pandemic potential or biological agents or toxins listed pursuant to such section 351A(a)(1); and</text></clause><clause id="HEBA54EDC47F24A09802B8A1C643A10E4"><enum>(ii)</enum><text>in a manner that does not compromise national security, the Director provides such evidence in a report submitted to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.</text></clause></subparagraph><subparagraph id="H6DA287BBA66F49C1B142635C846C05DD"><enum>(C)</enum><header>Limitation</header><text>Paragraph (1) shall not take effect with respect to a country of concern identified under subparagraph (B) until the date that is 15 days after the date on which the Director submits the report described in subparagraph (B)(ii).</text></subparagraph></paragraph><paragraph id="H56EE75D20A3C4CF492E494D0E6A49941"><enum>(3)</enum><header>Clarification</header><subparagraph id="H3E4726EC8498442AA64D33FAEA38C7C8"><enum>(A)</enum><header>In general</header><text>The requirement of paragraph (1) may be waived by the President for the duration of the initial response to an outbreak of a novel emerging infectious disease if the President determines that such requirement impedes the ability of the Federal Government to immediately respond to such outbreak.</text></subparagraph><subparagraph id="H60EAC79AF7AF4EBD9F3C38D0D2D32AF9"><enum>(B)</enum><header>Notification</header><text>The President shall notify such committees of Congress not later than 48 hours after exercising the waiver under subparagraph (A), and shall provide updates to such committees related to the use of such waiver every 15 days thereafter.</text></subparagraph></paragraph><paragraph id="H944F11EF92BB445EA57FA6EF9F8A8B57"><enum>(4)</enum><header>Sunset</header><text>The limitation under this subsection shall expire on December 31, 2026.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle><subtitle commented="no" level-type="subsequent" style="OLC" id="H884253C6C5EA4C76888FC5929A55A624"><enum>C</enum><header>Addressing the needs of all individuals</header><section id="H178F3DDB8CDF4F5E99F86C11F4F767F6" commented="no"><enum>631.</enum><header>Improving access to certain programs</header><subsection commented="no" display-inline="no-display-inline" id="H5AA55DF2467B4096AA605DF893A32792"><enum>(a)</enum><header display-inline="yes-display-inline">Procedures related to the transition of certain claims</header><paragraph id="H3D1B8CE519A14EE9A77AECB95BF4CD57" commented="no"><enum>(1)</enum><header>Procedures for correcting submissions</header><subparagraph commented="no" display-inline="no-display-inline" id="HC0C8E4B66DE14118AA17D376AB2FB6C5"><enum>(A)</enum><header>Requests initially submitted under section 319F–4</header><clause commented="no" display-inline="no-display-inline" id="H5F1A69BA84D24A009830EF37E192798B"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">In the case of a request for compensation submitted under section 319F–4 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6e">42 U.S.C. 247d–6e</external-xref>) for an injury or death related to a medical product for active immunization to prevent coronavirus disease 2019 that the Secretary determines to be ineligible pursuant to subsection (b)(4)(B) of such section 319F–4, the Secretary shall, not later than 30 days after such determination, notify the individual submitting the request of such determination. </text></clause><clause commented="no" display-inline="no-display-inline" id="HD93F38DF97C143C99EB797919B714FE2"><enum>(ii)</enum><header>Submission of petition</header><text display-inline="yes-display-inline">An individual who receives a notification described in clause (i) shall be eligible to submit a petition to the United States Court of Federal Claims under section 2111 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-11">42 U.S.C. 300aa–11</external-xref>) with respect to the same medical product administration claimed in the request submitted under section 319F–4 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6e">42 U.S.C. 247d–6e</external-xref>), provided such petition is submitted not later than the later of—</text><subclause commented="no" display-inline="no-display-inline" id="H6C81209AEEAB4A35A79159EA25EE745E"><enum>(I)</enum><text display-inline="yes-display-inline">1 year after receiving such notification under clause (i); or </text></subclause><subclause commented="no" display-inline="no-display-inline" id="HE58E52B201074ACA8C39CE92969FD133"><enum>(II)</enum><text display-inline="yes-display-inline">the last date on which the individual otherwise would be eligible to submit a petition relating to such injury, as specified in section 2116 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-16">42 U.S.C. 300aa–16</external-xref>).</text></subclause></clause><clause commented="no" display-inline="no-display-inline" id="H75742FC23E674F3B9C3D732B27D3ADA3"><enum>(iii)</enum><header>Eligibility</header><text>To be eligible to submit a petition in accordance with clause (ii), the petitioner shall have submitted the request that was determined to be ineligible as described in clause (i) not later than the applicable deadline for filing a petition under such section 2116. </text></clause></subparagraph><subparagraph id="HAB8AC41AE7EE41ADB3A419E2AC1ADE73" commented="no"><enum>(B)</enum><header>Requests initially submitted under section 2111</header><clause id="HAB3941489A964246940B873E551CA28A" commented="no"><enum>(i)</enum><header>In general</header><text>If a special master determines that—</text><subclause commented="no" display-inline="no-display-inline" id="H5EEE4D6436334199B2AE876EFD5551E4"><enum>(I)</enum><text display-inline="yes-display-inline">a petition submitted under section 2111 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-11">42 U.S.C. 300aa–11</external-xref>) related to a medical product for active immunization to prevent coronavirus disease 2019 that is ineligible for the program under subtitle 2 of title XXI of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-10">42 U.S.C. 300aa–10 et seq.</external-xref>) because it relates to a medical product administered at a time when the medical product was not included in the table under section 2114 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-14">42 U.S.C. 300aa–14</external-xref>); and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HB66EEADA6CBC4BCAA932F14B2A002C81"><enum>(II)</enum><text display-inline="yes-display-inline">the medical product was administered when it was a covered countermeasure subject to a declaration under section 319F–3(b) of such Act (42 U.S.C. 247d–6d(b)), </text></subclause><continuation-text continuation-text-level="clause" commented="no">the special master shall, not later than 30 days after such determination, notify the petitioner of such determination.</continuation-text></clause><clause id="H0144BB21084A4572A61FF1F7F99DD35E" commented="no"><enum>(ii)</enum><header>Submission of request</header><text display-inline="yes-display-inline">An individual who receives a notification described in clause (i) shall be eligible to submit a request for compensation under section 319F–4(b) of the Public Health Service Act (42 U.S.C. 247d–6e(b)) with respect to the same medical product administration claimed in the petition submitted under section 2111 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-11">42 U.S.C. 300aa–11</external-xref>)—</text><subclause commented="no" display-inline="no-display-inline" id="H75FA9EC9F28A466FA68D1B00CFC09F8A"><enum>(I)</enum><text display-inline="yes-display-inline">not later than 1 year after receiving such notification; or</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H3F470167C4414286A28CFA2883E062C1"><enum>(II)</enum><text>in the case that the notification is issued after judicial review of the petition under subsection (e) or (f) of section 2112 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-12">42 U.S.C. 300aa–12</external-xref>), not later than 1 year after the judgment of the United States Court of Federal Claims or the mandate is issued by the United States Court of Appeals for the Federal Circuit pursuant to such subsection (e) or (f).</text></subclause></clause><clause commented="no" display-inline="no-display-inline" id="H06F21230EEEC4CDA8D2EACE196E47FC1"><enum>(iii)</enum><header>Eligibility</header><text>To be eligible to submit a request for compensation in accordance with clause (ii), the individual submitting the request shall have submitted the petition under section 2111 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-11">42 U.S.C. 300aa–11</external-xref>) that was determined to be ineligible not later than 1 year after the date of administration of the medical product. </text></clause></subparagraph></paragraph><paragraph id="H746DEE4B20BC4E6FAE937E2AB4204E4D" commented="no"><enum>(2)</enum><header>Changes to certain programs</header><subparagraph commented="no" display-inline="no-display-inline" id="H5DA48EF4DF9A43AEABB5F44730CF6DD9"><enum>(A)</enum><header>Section 319F–4</header><text display-inline="yes-display-inline">Section 319F–4 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6e">42 U.S.C. 247d–6e</external-xref>) is amended—</text><clause commented="no" display-inline="no-display-inline" id="H6AE2F0AC53FE4FFC9071F703ABD5D402"><enum>(i)</enum><text>in subsection (b)(4)—</text><subclause id="HEC9A8806435244599065F63B567BC7F5" commented="no"><enum>(I)</enum><text>by striking <quote>Except as provided</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HF2063CA5FF824E25B35A1954325EA080"><subparagraph id="H09971B17EEE74AD2B4C5633B62424F5C" commented="no"><enum>(A)</enum><header>In general</header><text>Except as provided</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subclause><subclause id="HD34F6D59B5254129BC8CC7175630ABD7" commented="no"><enum>(II)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H0075B4C738B1490F98391A3581A716FE"><subparagraph id="H46BE8DDB2FE84D50B02BAE9D5C29233F" commented="no"><enum>(B)</enum><header>Exclusion of injuries eligible for petition under title XXI</header><text>Notwithstanding any other provision of this section, no individual may be eligible for compensation under this section with respect to a vaccine that, at the time it was administered, was included in the Vaccine Injury Table under section 2114.</text></subparagraph><after-quoted-block>; and </after-quoted-block></quoted-block></subclause></clause><clause id="H3D851DFC988A407DAFEFB915F462DD3B" commented="no"><enum>(ii)</enum><text>in subsection (d)(3)—</text><subclause id="HA01C4362B9614FF0B9534E0623F66F4E" commented="no"><enum>(I)</enum><text>by striking <quote>This section</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HEFB204089C284CC2BB20FA27A7C1C946"><subparagraph id="HBD1D90FDF2A0497D9A0E3F9F39DB9BBB" commented="no"><enum>(A)</enum><header>In general</header><text>This section</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subclause><subclause id="H6F96E5CC979D4A258E8D14852D34CAD6" commented="no"><enum>(II)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HD4E367BA4C5F4EF68BE62E4D248A4E1D"><subparagraph id="HBD76064C92D34651A89F65339B8DC2F8" commented="no"><enum>(B)</enum><header>Exhaustion of remedies</header><text>A covered individual shall not be considered to have exhausted remedies as described in paragraph (1), nor be eligible to seek remedy under section 319F–3(d), unless such individual has provided to the Secretary all supporting documentation necessary to facilitate the determinations required under subsection (b)(4).</text></subparagraph><after-quoted-block>. </after-quoted-block></quoted-block></subclause></clause></subparagraph><subparagraph id="HEDB2A0C983484F579371A4A23E6D24F8" commented="no"><enum>(B)</enum><header>Title XXI</header><text>Title XXI of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-1">42 U.S.C. 300aa–1 et seq.</external-xref>) is amended—</text><clause id="H422328C4E6534398B38980D8BC551C4F" commented="no"><enum>(i)</enum><text>in section 2111(a)(2)(A) (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-11">42 U.S.C. 300aa–11(a)(2)(A)</external-xref>), in the matter preceding clause (i), by inserting <quote>containing the information required under subsection (c)</quote> after <quote>unless a petition</quote>; </text></clause><clause id="H1B0105625D34465099A859BA38738763" commented="no"><enum>(ii)</enum><text>in section 2112(d) (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-12">42 U.S.C. 300aa–12(d)</external-xref>)— </text><subclause id="HE7097380B0F44DC89D91E229B3DF34D4" commented="no"><enum>(I)</enum><text>by adding at the end of paragraph (1) the following: <quote>Such designation shall not occur until the petitioner has filed all materials required under section 2111(c).</quote>; and </text></subclause><subclause id="HAC20FC6CA7A149C59C272CF6BD473DA4" commented="no"><enum>(II)</enum><text>in paragraph (3)(A)(ii), by striking <quote>the petition was filed</quote> and inserting <quote>on which the chief special master makes the designation pursuant to paragraph (1)</quote>; </text></subclause></clause><clause id="HBD41EF1DCCCE4E6C917665A58EFD973B" commented="no"><enum>(iii)</enum><text display-inline="yes-display-inline">in section 2114(e) (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-14">42 U.S.C. 300aa–14(e)</external-xref>), by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HB2338369576449D183B4B02CB12C5575"><paragraph id="H78913F70980A495FB39ED53E48DA4996" commented="no"><enum>(4)</enum><header>Licensure requirement</header><text>Notwithstanding paragraphs (2) and (3), the Secretary may not revise the Vaccine Injury Table to include a vaccine for which the Centers for Disease Control and Prevention has issued a recommendation for routine use in children or pregnant women until at least one application for such vaccine has been approved under section 351. Upon such revision of the Vaccine Injury Table, all vaccines in a vaccine category on the Vaccine Injury Table, including vaccines authorized under emergency use pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act, shall be considered included in the Vaccine Injury Table.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause><clause id="H2B4C3A362B3E45C49442AEDB7FC2B3BD" commented="no"><enum>(iv)</enum><text>in section 2116 (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-16">42 U.S.C. 300aa–16</external-xref>), by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HC4AB01542F304FF3B0E2BBCA2BFFA782"><subsection id="HDDB44E7206DC4980AFCE5FF0ED068B7B" commented="no"><enum>(d)</enum><header>Clarification</header><text>Notwithstanding subsections (a) and (b), an injury or death related to a vaccine administered at a time when the vaccine was a covered countermeasure subject to a declaration under section 319F–3(b) shall not be eligible for compensation under the Program.</text></subsection><after-quoted-block>. </after-quoted-block></quoted-block></clause></subparagraph></paragraph></subsection><subsection id="H6CEC25E2AEB94A2B9071B33EC5121DF0" commented="no"><enum>(b)</enum><header>Accelerating injury compensation program administration and ensuring program integrity</header><paragraph id="HF38315F3F151463294B3B62302605BC4" commented="no"><enum>(1)</enum><header>Petitions for compensation</header><text>Section 2111(a)(2)(A)(i) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-11">42 U.S.C. 300aa–11(a)(2)(A)(i)</external-xref>) is amended—</text><subparagraph id="HC5764316F25B413F97A6E97F12933488" commented="no"><enum>(A)</enum><text>in subclause (I), by striking <quote>, and</quote> and inserting a semicolon;</text></subparagraph><subparagraph id="H04B3D9C7BBAE4D6880AD616F71775471" commented="no"><enum>(B)</enum><text>in subclause (II)—</text><clause id="H70B2AF4CACAC45BAAAB1D775543BCF18" commented="no"><enum>(i)</enum><text>by moving the margin 2 ems to the right; and</text></clause><clause id="H95FD41BD7D9747C39FF061C440FA7774" commented="no"><enum>(ii)</enum><text>by striking <quote>, or</quote> and inserting <quote>; and</quote>; and</text></clause></subparagraph><subparagraph id="HC351B8497BDB4C99BB095CD6B52A3472" commented="no"><enum>(C)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H5369185767D44A8091319444554E70F9"><subclause id="HCEECA139AC6344208A5BF26C1E734C73" indent="up2" commented="no"><enum>(III)</enum><text>the judgment described in subclause (I) does not result from a petitioner's motion to dismiss the case; or</text></subclause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H458A85F4A46F4DE285FB2499FDA900B8" commented="no"><enum>(2)</enum><header>Determination of good faith</header><text>Section 2115(e)(1) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-15">42 U.S.C. 300aa–15(e)(1)</external-xref>) is amended by adding at the end the following: <quote>When making a determination of good faith under this paragraph, the special master or court may consider whether the petitioner demonstrated an intention to obtain compensation on such petition and was not merely seeking to satisfy the exhaustion requirement under section 2121(b).</quote>. </text></paragraph></subsection><subsection id="HDB8181ACB5A54D50B7651642D538908F" commented="no"><enum>(c)</enum><header>Extension of deadlines To submit requests for compensation for certain injuries</header><paragraph id="H788C7632EF51422E96BF6CA7E287411F" commented="no"><enum>(1)</enum><header>In general</header><text>With respect to claims filed under section 319F–4 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6e">42 U.S.C. 247d–6e</external-xref>) alleging a covered injury caused by the administration or use of a covered countermeasure pursuant to a declaration under section 319F–3(b) of such Act (42 U.S.C. 247d–6d(b)) relating to coronavirus disease 2019, the following shall apply:</text><subparagraph id="H675A2E1B3DFF44DD9687FE01F7BD7680" commented="no"><enum>(A)</enum><text>Notwithstanding the filing deadline applicable under such section 319F–4, the claim shall be filed within 3 years of the administration or use of the covered countermeasure, or 1 year after the date of enactment of this Act, whichever is later, and, if a claim filed under such section 319F–4 with respect to such administration or use was filed before the date of enactment of this Act and denied on the basis of having not been filed within the time period required under subsection (b)(4) of such section 319F–4, such claim may be refiled pursuant to this subparagraph.</text></subparagraph><subparagraph id="H00F08E3E14C0402898FB1F1EB9AB2029" commented="no"><enum>(B)</enum><text>With respect to a claim relating to the administration of a medical product for active immunization to prevent coronavirus disease 2019 such a claim may be filed under such section 319F–4 only if the administration of such vaccine occurred prior to the addition of the vaccine to the Vaccine Injury Table under section 2114 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-14">42 U.S.C. 300aa–14</external-xref>).</text></subparagraph></paragraph></subsection></section><section commented="no" id="H94CDEDA18B744201807124AF4F47793B"><enum>632.</enum><header>Supporting at-risk individuals during emergency responses</header><subsection commented="no" display-inline="no-display-inline" id="H06945E22A0C943F6AF4593BCC66455CA"><enum>(a)</enum><header display-inline="yes-display-inline">Technical assistance for at-Risk individuals and disasters</header><paragraph id="HD92E118A3E20430688844A6BDC906818"><enum>(1)</enum><header>In general</header><text>The Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) may provide appropriate technical assistance to States, localities, Tribes, and other applicable entities related to addressing the unique needs and considerations of at-risk individuals, as defined in section 2802(b)(4) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-1">42 U.S.C. 300hh–1(b)(4)</external-xref>), in the event of a public health emergency declared by the Secretary pursuant to section 319 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d">42 U.S.C. 247d</external-xref>).</text></paragraph><paragraph id="H759862CA45AD4DB2AA047136866E5A87"><enum>(2)</enum><header>Technical assistance</header><text>The technical assistance described in paragraph (1) shall include—</text><subparagraph id="HA636A90E0374488898E81EB376EDE59B"><enum>(A)</enum><text>developing, identifying, evaluating, and disseminating evidence-based or evidence-informed strategies to improve health and address other near-term or long-term outcomes for at-risk individuals related to public health emergencies, including by addressing such unique needs and considerations in carrying out public health and medical activities to prepare for, respond to, and recover from, such public health emergencies; and</text></subparagraph><subparagraph id="H627A648E26B4450EB87C4A9880AB3D46"><enum>(B)</enum><text>assisting applicable entities, through contracts or cooperative agreements, as appropriate, in the implementation of such evidence-based strategies. </text></subparagraph></paragraph><paragraph id="HDF4C344E3A6B4841AC8E01345A7DC4B9"><enum>(3)</enum><header>Consultation</header><text>In carrying out activities under paragraph (2), the Secretary shall take into consideration relevant findings and recommendations of, and, as appropriate, consult with, the National Advisory Committee on Individuals with Disabilities and Disasters established under section 2811C of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10d">42 U.S.C. 300hh–10d</external-xref>), the National Advisory Committee on Children and Disasters under section 2811A of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10b">42 U.S.C. 300hh–10b</external-xref>), and the National Advisory Committee on Seniors and Disasters under section 2811B of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10c">42 U.S.C. 300hh–10c</external-xref>).</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H9470399401804A9082654AC472B9A8C0"><enum>(b)</enum><header>Crisis standards of care</header><text>Not later than 2 years after the date of enactment of this Act, the Secretary, acting through the Director of the Office for Civil Rights of the Department of Health and Human Services, shall issue guidance to States and localities on the development or modification of State and local crisis standards of care for use during the response to a public health emergency declared by the Governor of a State or by the Secretary under section 319 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d">42 U.S.C. 247d</external-xref>), or a major disaster or emergency declared by the President under section 401 or 501, respectively, of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/42/5170">42 U.S.C. 5170</external-xref>, 5191) to ensure that such standards of care are consistent with the nondiscrimination requirements of section 504 of the Rehabilitation Act of 1973 (<external-xref legal-doc="usc" parsable-cite="usc/29/794">29 U.S.C. 794</external-xref>), title II of the Americans with Disabilities Act of 1990 (<external-xref legal-doc="usc" parsable-cite="usc/42/12131">42 U.S.C. 12131 et seq.</external-xref>), and the Age Discrimination Act of 1975 (<external-xref legal-doc="usc" parsable-cite="usc/42/6101">42 U.S.C. 6101 et seq.</external-xref>). </text></subsection></section><section id="H731924506FF54B639C07DF29D5482E17"><enum>633.</enum><header>National advisory committees</header><subsection commented="no" display-inline="no-display-inline" id="H0ECB2A7970C44DC88E5C1641AF26314E"><enum>(a)</enum><header display-inline="yes-display-inline">National Advisory Committee on Children and Disasters</header><text>Subsection (g) of section 2811A of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10b">42 U.S.C. 300hh–10b</external-xref>) is amended to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HA3B7741A7DF64158A4E95DC74FF62445"><subsection id="HC75F5A4B21484505ACDAF6A7E5C51684" commented="no"><enum>(g)</enum><header>Sunset</header><paragraph commented="no" display-inline="no-display-inline" id="HD2B980D50C3F477683718C5722876CC2"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text>The Advisory Committee shall terminate on December 31, 2026.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H624F83CC5B6844B89CE733544365FF00"><enum>(2)</enum><header>Extension of Advisory Committee</header><text>Not later than October 1, 2025, the Secretary shall submit to Congress a recommendation on whether the Advisory Committee should be extended beyond the date described in paragraph (1).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection commented="no" display-inline="no-display-inline" id="H286A6D359408405EB49C0D2C2328CA79"><enum>(b)</enum><header>National advisory committee on seniors and disasters</header><text>Section 2811B of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10c">42 U.S.C. 300hh–10c</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H7E222FD09F3A4E70854606C82246EE4B"><enum>(1)</enum><text>in subsection (d)—</text><subparagraph commented="no" display-inline="no-display-inline" id="H71ADF69061EF490896D0EF9892B65FB6"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text><clause commented="no" display-inline="no-display-inline" id="H4602B16104244491818B3C9A352CA9B7"><enum>(i)</enum><text display-inline="yes-display-inline">by inserting <quote>and departments</quote> after <quote>agencies</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H532F627278034DCDABF6E3E725F255AF"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>17 members</quote> and inserting <quote>25 members</quote>; and</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HE7CE5D14788B48D2AC8AF77007121486"><enum>(B)</enum><text>in paragraph (2)—</text><clause commented="no" display-inline="no-display-inline" id="HCCB163149A0A46C1A4DDBA743C5A81E6"><enum>(i)</enum><text>by striking subparagraphs (J) and (K);</text></clause><clause commented="no" display-inline="no-display-inline" id="H5DB5625453A246538A8A20D870E09BBC"><enum>(ii)</enum><text>by redesignating subparagraphs (A) through (I) and (L) as clauses (i) through (x), respectively, and adjusting the margins accordingly; </text></clause><clause commented="no" display-inline="no-display-inline" id="H057FF6493A2B407482F72E279B3888C6"><enum>(iii)</enum><text>by inserting before clause (i), as so redesignated, the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H747E0A46EA274797949A9E2F66A0DE07"><subparagraph id="HCBF6A9D9B652493796D881D544B3BDA8"><enum>(B)</enum><header>Federal members</header><text>The Federal members shall include the following:</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause><clause id="H453083FD737D4BFF8B3C105AB7EADF5A"><enum>(iv)</enum><text>by inserting before subparagraph (B), as so designated, the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H2DC2608AB47647D99BF02AED2EA49D0C"><subparagraph id="H2FEA9D5E11C540578C47E61339C2A944"><enum>(A)</enum><header>Non-Federal members</header><text>The Secretary in consultation with such other heads of agencies and departments as may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals, including the following:</text><clause commented="no" display-inline="no-display-inline" id="H12782C1B7B724E32A0FB677262C19C2E"><enum>(i)</enum><text display-inline="yes-display-inline">At least 3 non-Federal health care providers with expertise in geriatric medical disaster planning, preparedness, response, or recovery.</text></clause><clause commented="no" display-inline="no-display-inline" id="H471827389F73474B8DEF50C24B6BF525"><enum>(ii)</enum><text display-inline="yes-display-inline">At least 3 representatives of State, local, territorial, or Tribal agencies with expertise in geriatric disaster planning, preparedness, response, or recovery.</text></clause><clause commented="no" display-inline="no-display-inline" id="HB74E857098D44AE2B9297DBACD79CEE4"><enum>(iii)</enum><text display-inline="yes-display-inline">At least 2 non-Federal professionals with training in gerontology, such as social workers, scientists, human services specialists, or other non-medical professionals, with experience in disaster planning, preparedness, response, or recovery among other adults.</text></clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0F264259E63443A08DA6B30D8827B8E2"><enum>(2)</enum><text>by amending subsection (g) to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H39A801DB472143FBA5713D120DC55863"><subsection id="H74454FDD779D49E197D02DC9CD12EBC8" commented="no"><enum>(g)</enum><header>Sunset</header><text>The Advisory Committee shall terminate on December 31, 2026.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H804FB73B270445E987F6E561DB39F259"><enum>(c)</enum><header>National advisory committee on individuals with disabilities and disasters</header><text>Section 2811C of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10d">42 U.S.C. 300hh–10d</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="HD92CC381F4614ADAAFF8C74E2EBD4ABA"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating subsections (c) through (g) as subsections (d) through (h), respectively;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H61B312AF6CC04207A5900CB4DFD5953B"><enum>(2)</enum><text>by inserting after subsection (b) the following: </text><quoted-block style="OLC" display-inline="no-display-inline" id="H450F4B9F5BD44735A72E6DD29BF571E1"><subsection id="HF6041E76B03F4325BDA6310406D2CDDD"><enum>(c)</enum><header>Additional duties</header><text>The Advisory Committee may provide advice and recommendations to the Secretary with respect to individuals with disabilities and the medical and public health grants and cooperative agreements as applicable to preparedness and response activities under this title and title III.</text></subsection><after-quoted-block>;</after-quoted-block></quoted-block></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H8CD9F9D832FF4DB9B4B8FCFB01F3DB4C"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (d), as so redesignated—</text><subparagraph commented="no" display-inline="no-display-inline" id="H67CA411B63C04624AD8E5BDEA0739C30"><enum>(A)</enum><text>in paragraph (1), by striking <quote>17 members</quote> and inserting <quote>25 members</quote>;</text></subparagraph><subparagraph id="HB998933800DC4B9A86511D2471C613F7"><enum>(B)</enum><text>in paragraph (2)—</text><clause id="H710822361AC14C45BE20FD25CC51FA58"><enum>(i)</enum><text>by striking subparagraphs (K) through (M); </text></clause><clause commented="no" display-inline="no-display-inline" id="H4E3F0AB2C47A4AFA86D2CC7B06C080BA"><enum>(ii)</enum><text display-inline="yes-display-inline">by redesignating subparagraphs (A) through (J) as clauses (i) through (x), respectively, and adjusting the margins accordingly;</text></clause><clause commented="no" display-inline="no-display-inline" id="H60E37A187FC343FB92362A0B559CBB23"><enum>(iii)</enum><text>by inserting before clause (i), as so redesignated, the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H7C5354EC3250418EA082B5CDC138C9F0"><subparagraph id="H573EB16E21C84563BB7FB12E91DEFC5B"><enum>(B)</enum><header>Federal members</header><text>The Federal members shall include the following:</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause><clause commented="no" display-inline="no-display-inline" id="H123000002C31414DBA6C02053EC48A37"><enum>(iv)</enum><text>by adding at the end of subparagraph (B), as so designated, the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H93740E70C7A14E59A2CC93C8B5E3AB05"><clause id="H4D809054E0994C189EC1EA02528B0C88"><enum>(xi)</enum><text>Representatives of such other Federal agencies as the Secretary determines necessary to fulfill the duties of the Advisory Committee.</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></clause><clause commented="no" display-inline="no-display-inline" id="H8721C96E12CC41AC8E8D9AB9D0853492"><enum>(v)</enum><text display-inline="yes-display-inline">by inserting before subparagraph (B), as so designated, the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HA2154733062E4098924AA88DE0D7E79E"><subparagraph id="HC41A66628E13484080E44D242D663802"><enum>(A)</enum><header>Non-Federal members</header><text>The Secretary in consultation with such other heads of agencies and departments as may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals, including the following:</text><clause id="HED447D6C62704EC6BCAFE45BC32A75FD"><enum>(i)</enum><text>At least 4 non-Federal health care professionals with expertise in disability accessibility before, during, and after disasters, medical and mass care disaster planning, preparedness, response, or recovery.</text></clause><clause commented="no" display-inline="no-display-inline" id="H6868C1761AF74A35A85525F19308186E"><enum>(ii)</enum><text display-inline="yes-display-inline">At least 3 representatives of State, local, Tribal, or territorial agencies with expertise in disaster planning, preparedness, response, or recovery for individuals with disabilities.</text></clause><clause commented="no" display-inline="no-display-inline" id="H5BC2172546114FF68F7D4E203DB27308"><enum>(iii)</enum><text display-inline="yes-display-inline">At least 4 individuals with a disability with expertise in disaster planning, preparedness, response, or recovery for individuals with disabilities.</text></clause><clause id="HD9F76A787F6E413B8FE921ED23151326"><enum>(iv)</enum><text>Other members as the Secretary determines appropriate, of whom—</text><subclause id="H06FF3CFBA1314E1B925A03E46C5827C5"><enum>(I)</enum><text>at least one such member shall represent a local, State, or national organization with expertise in individuals with disabilities;</text></subclause><subclause id="H89A8F1A82E1D48DCBA572890D8C5E14A"><enum>(II)</enum><text>at least one such member shall be an individual with a disability; and</text></subclause><subclause id="HF6E67684292B41948ADA0A2C86BE3177"><enum>(III)</enum><text>at least one such member shall be an individual with expertise in the needs of housing services, including during the response to, and recovery from, disasters.</text></subclause></clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="H9741A241FE914794B6EAC1252E3BAA30"><enum>(C)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H76A563C6BF674A01B571D2F36968135A"><paragraph id="HD9382171B6C645F58F7C2817C981DC86"><enum>(3)</enum><header>Consideration</header><text>In appointing members, including the Chair, to the Committee under this subsection, the Secretary may give consideration to disability status.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD2616E690CB04796B8CFB0E050CB90FF"><enum>(4)</enum><text>by amending subsection (h), as so redesignated, to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H0B12E057ADBB46F99B01AC8A1AF7D80D"><subsection id="HCA56E7634B554D5A83F0CD902416C07D" commented="no"><enum>(h)</enum><header>Sunset</header><text>The Advisory Committee shall terminate on December 31, 2026.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section><section id="HF0DAFF89F2CB45798B4610871D793320" commented="no"><enum>634.</enum><header>National Academies study on prizes</header><subsection id="H9A3D12EBD37B4E4A916D167FEB640B65" commented="no"><enum>(a)</enum><header>In general</header><text>Not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services shall seek to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (referred to in this section as the <quote>National Academies</quote>) to conduct a study to examine—</text><paragraph id="H436F00670BB84E6FB5C0647053EE2E6E" commented="no"><enum>(1)</enum><text>alternative models for directly funding, or stimulating investment in, biomedical research and development that delink research and development costs from the prices of drugs, including the progressive replacement of patents and regulatory exclusivities on new drugs with a combination of expanded support for research and innovation prizes to reward the successful development of drugs or achievement of related milestones;</text></paragraph><paragraph id="H7C2161C5A90840D9B1129BFF3DCAC966" commented="no"><enum>(2)</enum><text>the dollar amount of innovation prizes for different stages of research and development of different classes or types of drugs, and total annual funding, that would be necessary to stimulate investment sufficient to achieve such successful drug development and related milestones;</text></paragraph><paragraph id="HB6A044177CC74D37B1DB3434264616C8" commented="no"><enum>(3)</enum><text>the relative effectiveness and efficiency of such alternative models in stimulating innovation, compared to the status quo that includes patents and regulatory exclusivities;</text></paragraph><paragraph id="HC57617F185374E9D846AE46BAD6524EF" commented="no"><enum>(4)</enum><text>strategies to implement such alternative models described in paragraph (1), including a phased transition; and</text></paragraph><paragraph id="H83D9F0B7800F43FAA68367100879488C" commented="no"><enum>(5)</enum><text>the anticipated economic and societal impacts of such alternative models, including an assessment of impact on—</text><subparagraph id="HC7DE78834D664463A0A109D715A3F870" commented="no"><enum>(A)</enum><text>the number and variety of new drugs that would be developed, approved, and marketed in the United States, including such new drugs intended to prevent, diagnose, or treat a rare disease or condition;</text></subparagraph><subparagraph id="H985DF24A241F411E974479F446C6E4E0" commented="no"><enum>(B)</enum><text>the rate at which new drugs would be developed, approved, and marketed in the United States;</text></subparagraph><subparagraph id="HBBB773BA09B342F3B95C63A85199A01D" commented="no"><enum>(C)</enum><text>access to medication; </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H33652A3498AD484E99C4968F3C68CAD7"><enum>(D)</enum><text display-inline="yes-display-inline">health outcomes;</text></subparagraph><subparagraph id="H907EE014E582488C8DC3466A7F53C0FB" commented="no"><enum>(E)</enum><text>average lifespan and disease burden in the United States;</text></subparagraph><subparagraph id="HB77CDDA4FD0E45BA9B3CF01B8ED50947" commented="no"><enum>(F)</enum><text>the number of manufacturers that would be seeking approval for a drug or bringing a drug to market for the first time;</text></subparagraph><subparagraph id="H1D0B1C83AA0A47559A35A1CC02BD6E17" commented="no"><enum>(G)</enum><text>Federal discretionary and mandatory spending; and</text></subparagraph><subparagraph id="H65B1A1136F074A819DF1ED8469B131A3" commented="no"><enum>(H)</enum><text>public and private insurance markets.</text></subparagraph></paragraph></subsection><subsection id="H3D9060335DAE426FA00F939D81C24544" commented="no"><enum>(b)</enum><header>Requirements</header><text>In conducting the study pursuant to subsection (a), the National Academies shall hold not fewer than 2 public listening sessions to solicit feedback from interested parties, including representatives of academia, professional societies, patient advocates, public health organizations, relevant Federal departments and agencies, drug developers, representatives of other relevant industries, and subject matter experts.</text></subsection><subsection id="H77AAE94710FA4A4F9E457A23CC0FE32A" commented="no"><enum>(c)</enum><header>Report</header><text>Not later than 2 years after the agreement under subsection (a), the National Academies shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report on the study conducted pursuant to subsection (a). </text></subsection></section></subtitle><subtitle id="HF4A66DED74A94278AE38967E66D5AA11" style="OLC"><enum>D</enum><header>Additional reauthorizations</header><section id="HFDADEAE9569A423699A7121AB4C00430" commented="no"><enum>641.</enum><header>Medical countermeasure priority review voucher</header><text display-inline="no-display-inline">Section 565A(g) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360bbb-4a">21 U.S.C. 360bbb–4a</external-xref>) is amended by striking <quote>October 1, 2023</quote> and inserting <quote>December 31, 2026</quote>.</text></section><section id="H3420B89A5CE64C6B9AF9092EEB5D9ACA"><enum>642.</enum><header>Epidemic Intelligence Service</header><text display-inline="no-display-inline">Section 317F(c)(2) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-7">42 U.S.C. 247b–7(c)(2)</external-xref>) is amended by striking <quote>2019 through 2023</quote> and inserting <quote>2025 and 2026, to remain available through December 31, 2026</quote>.</text></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="HD736404DDD5C445FB7119B0FE11523DD"><enum>643.</enum><header>Monitoring and distribution of certain medical countermeasures</header><text display-inline="no-display-inline">Section 319A(e) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-1">42 U.S.C. 247d–1(e)</external-xref>) is amended by striking <quote>2019 through 2023</quote> and inserting <quote>2025 and 2026, to remain available through December 31, 2026</quote>.</text></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="H8265580EA16A45CE83D6526D111A4E24"><enum>644.</enum><header>Regional health care emergency preparedness and response systems</header><text display-inline="no-display-inline">Section 319C–3 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-3c">42 U.S.C. 247d–3c</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H0D817B3030984409BA09BDC646066BF2"><enum>(1)</enum><text>in subsection (b)(3), by striking <quote>under the</quote> and all that follows through <quote>such Act)</quote> and inserting <quote>under law</quote>; and </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD04EA008697B48A79D8C155C6828DB9D"><enum>(2)</enum><text>in subsection (e)(2), by striking <quote>September 30, 2023</quote> and inserting <quote>December 31, 2026</quote>.</text></paragraph></section><section id="H8AA277C7827645BB96560F7733AFC9B2"><enum>645.</enum><header>Emergency system for advance registration of volunteer health professionals</header><paragraph id="HD593187F51064839AA6AB383DA5F467D"><enum>(1)</enum><header>In general</header><text>Section 319I of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-7b">42 U.S.C. 247d–7b</external-xref>) is amended—</text><subparagraph id="H32C16F01E2C640F7B1F5AD456E9C8E2C"><enum>(A)</enum><text>in subsection (a), by striking <quote>Not later than 12 months after the date of enactment of the Pandemic and All-Hazards Preparedness Act, the Secretary shall link existing State verification systems to maintain a single national interoperable network of systems,</quote> and inserting <quote>The Secretary shall continue to maintain a single national interoperable network of verification systems,</quote> and</text></subparagraph><subparagraph id="HFA5A0A076D89449D9806BE66800F1040" commented="no"><enum>(B)</enum><text>in subsection (k), by striking <quote>2019 through 2023</quote> and inserting <quote>2025 and 2026, to remain available through December 31, 2026</quote>.</text></subparagraph></paragraph></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="H83CEB6A1FD184D21A4870A8B3B014059"><enum>646.</enum><header>Ensuring collaboration and coordination in medical countermeasure development</header><text display-inline="no-display-inline">Section 319L–1(b) of the Public Health Service Act (42 U.S.C. 247d–7f(b)) is amended by striking <quote>March 31, 2025</quote> and inserting <quote>December 31, 2026</quote>. </text></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="HBD70203012404CDCA70C0C6314A06DBD"><enum>647.</enum><header>Military and civilian partnership for trauma readiness</header><text display-inline="no-display-inline">Section 1291(g) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300d-91">42 U.S.C. 300d–91(g)</external-xref>) is amended by striking <quote>2019 through 2023</quote> and inserting <quote>2025 and 2026, to remain available through December 31, 2026</quote>.</text></section><section id="H1BA195219A3844B0B7D1306309F44176"><enum>648.</enum><header>National Disaster Medical System</header><text display-inline="no-display-inline">Section 2812 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-11">42 U.S.C. 300hh–11</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H6F5422923F7E4CD987504651970A2271"><enum>(1)</enum><text>in subsection (c)(4)(B), by striking <quote>March 31, 2025</quote> and inserting <quote>December 31, 2026</quote>; and </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3461B0C852A741EE984975B165D1D876"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (g), by striking <quote>$57,400,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$65,900,000 for each of fiscal years 2025 and 2026, to remain available through December 31, 2026</quote>.</text></paragraph></section><section id="H846C4BB76C9F47109CA16EF93D5E4CFC"><enum>649.</enum><header>Volunteer Medical Reserve Corps</header><text display-inline="no-display-inline">Section 2813(i) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-15">42 U.S.C. 300hh–15(i)</external-xref>) is amended by striking <quote>2019 through 2023</quote> and inserting <quote>2025 through 2026, to remain available through December 31, 2026</quote>.</text></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="HB923CE179785494EB67D11686B74B528"><enum>650.</enum><header>Epidemiology-laboratory capacity</header><text display-inline="no-display-inline">Section 2821(b) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-31">42 U.S.C. 300hh–31(b)</external-xref>) is amended, in the matter preceding paragraph (1), by striking <quote>2019 through 2023</quote> and inserting <quote>2025 and 2026, to remain available through December 31, 2026</quote>.</text></section></subtitle></title><title id="HA8813E0D884B45D0B13364A5075DDF7B"><enum>VII</enum><header>Public Health Programs</header><section id="HD439FEB82A81488DB6CA605264DC1C88"><enum>701.</enum><header>Action for dental health</header><text display-inline="no-display-inline">Section 340G(f) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/256g">42 U.S.C. 256g(f)</external-xref>) is amended by striking <quote>$13,903,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$15,000,000 for each of fiscal years 2025 through 2029, to remain available until expended</quote>.</text></section><section id="H222475A60E834D37966D56DBA45F5483"><enum>702.</enum><header>PREEMIE</header><subsection id="H96327AE60AE64E75A70218C61C32EC68" display-inline="no-display-inline"><enum>(a)</enum><header>Research relating to preterm labor and delivery and the care, treatment, and outcomes of preterm and low birthweight infants</header><paragraph id="HEC046F727EFC4662927EE09D7A973EC7"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 3(e) of the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act (42 U.S.C. 247b–4f(e)) is amended by striking <quote>fiscal years 2019 through 2023</quote> and inserting <quote>fiscal years 2025 through 2029</quote>.</text></paragraph><paragraph id="H01D78C4DE50B49B885A546E2BDBEC5F7"><enum>(2)</enum><header>Technical correction</header><text display-inline="yes-display-inline">Effective as if included in the enactment of the PREEMIE Reauthorization Act of 2018 (<external-xref legal-doc="public-law" parsable-cite="pl/115/328">Public Law 115–328</external-xref>), section 2 of such Act is amended, in the matter preceding paragraph (1), by striking <quote>Section 2</quote> and inserting <quote>Section 3</quote>. </text></paragraph></subsection><subsection id="HAE95379E027A4AB1B4A9555ED90CA7FD"><enum>(b)</enum><header>Interagency working group</header><text>Section 5(a) of the PREEMIE Reauthorization Act of 2018 (<external-xref legal-doc="public-law" parsable-cite="pl/115/328">Public Law 115–328</external-xref>) is amended by striking <quote>The Secretary of Health and Human Services, in collaboration with other departments, as appropriate, may establish</quote> and inserting <quote>Not later than 18 months after the date of the enactment of Lower Costs for Everyday Americans Act, the Secretary of Health and Human Services, in collaboration with other departments, as appropriate, shall establish</quote>. </text></subsection><subsection id="HE66B5A3E9D694E3DA8A57162326EC8FE"><enum>(c)</enum><header>Study on preterm births</header><paragraph id="H41AAAFD23EE34358B05D480175692798"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services shall enter into appropriate arrangements with the National Academies of Sciences, Engineering, and Medicine under which the National Academies shall—</text><subparagraph id="H396A44582694420CAC07770CF7D3FA7E"><enum>(A)</enum><text>not later than 30 days after the date of enactment of this Act, convene a committee of experts in maternal health to study premature births in the United States; and</text></subparagraph><subparagraph id="H3172FFA846B144A9B154E9573AB96217" commented="no"><enum>(B)</enum><text>upon completion of the study under subparagraph (A)—</text><clause id="H89708A5A4BED4238AD866D217BBEC144" commented="no"><enum>(i)</enum><text>approve by consensus a report on the results of such study; </text></clause><clause id="H32963F806B8A4110A617FECFD92AE12B" commented="no"><enum>(ii)</enum><text display-inline="yes-display-inline">include in such report—</text><subclause id="H3068BDBB92F6464886DB51446127AC0B" commented="no"><enum>(I)</enum><text>an assessment of each of the topics listed in paragraph (2);</text></subclause><subclause id="H908AF7927C604F1590626C10DBDB8B41" commented="no"><enum>(II)</enum><text>the analysis required by paragraph (3); and</text></subclause><subclause id="H03F1F055612846A9A3D5A06187B1AFA6" commented="no"><enum>(III)</enum><text>the raw data used to develop such report; and</text></subclause></clause><clause id="H89212C711FEF45E88CDBE80F56274670" commented="no"><enum>(iii)</enum><text display-inline="yes-display-inline">not later than 24 months after the date of enactment of this Act, transmit such report to—</text><subclause id="HD8084372A3DA4CDB940E3E691D9061E7" commented="no"><enum>(I)</enum><text>the Secretary of Health and Human Services;</text></subclause><subclause id="HDFB417279F55401E93DC64FEA2DF5BFB" commented="no"><enum>(II)</enum><text>the Committee on Energy and Commerce of the House of Representatives; and</text></subclause><subclause id="HDD7F7A72066241CDBDE0DDD91502EA2D" commented="no"><enum>(III)</enum><text>the Committee on Finance and the Committee on Health, Education, Labor, and Pensions of the Senate.</text></subclause></clause></subparagraph></paragraph><paragraph id="H52EDDCA990EF45E6B89BC0C4D41E7E5E"><enum>(2)</enum><header>Assessment topics</header><text display-inline="yes-display-inline">The topics listed in this subsection are each of the following:</text><subparagraph id="HBDA894AC36BB40E38283B3A57F88BAF0"><enum>(A)</enum><text display-inline="yes-display-inline">The financial costs of premature birth to society, including—</text><clause id="HC2201F4216514CA7814E8A76E0D81F2E"><enum>(i)</enum><text>an analysis of stays in neonatal intensive care units and the cost of such stays;</text></clause><clause id="HFE4DF4C99837494A84568D46DC19B40B"><enum>(ii)</enum><text>long-term costs of stays in such units to society and the family involved post-discharge; and</text></clause><clause id="H61C3F77F898D48E6904DC50418B0EAD7"><enum>(iii)</enum><text>health care costs for families post-discharge from such units (such as medications, therapeutic services, co-payments for visits, and specialty equipment).</text></clause></subparagraph><subparagraph id="HC6EBFE71403E4C36B18ED0A09149890D"><enum>(B)</enum><text display-inline="yes-display-inline">The factors that impact preterm birth rates.</text></subparagraph><subparagraph id="H147E2E1F9B8B470D93AF2BA77A2C7EF3"><enum>(C)</enum><text display-inline="yes-display-inline">Opportunities for earlier detection of premature birth risk factors, including—</text><clause id="HA9F3A1B6421F4C6BA906EE1C9A78D0D3"><enum>(i)</enum><text>opportunities to improve maternal and infant health; and</text></clause><clause id="H8C1F11908E274EB2BA6C861977F4D156"><enum>(ii)</enum><text>opportunities for public health programs to provide support and resources for parents in-hospital, in non-hospital settings, and post-discharge.</text></clause></subparagraph></paragraph><paragraph id="H6BB20D886DC640AF9C40E95B8A949FBA"><enum>(3)</enum><header>Analysis</header><text display-inline="yes-display-inline">The analysis required by this subsection is an analysis of—</text><subparagraph id="H2A95740EEB0D449186C7E250E5135509"><enum>(A)</enum><text display-inline="yes-display-inline">targeted research strategies to develop effective drugs, treatments, or interventions to bring at-risk pregnancies to term;</text></subparagraph><subparagraph id="H7E4D493E33D84B51966F930551E87FA2"><enum>(B)</enum><text>State and other programs’ best practices with respect to reducing premature birth rates; and</text></subparagraph><subparagraph id="H499F1F97EB56435AAD5CD78DBC87A7FB"><enum>(C)</enum><text>precision medicine and preventative care approaches starting early in the life course (including during pregnancy) with a focus on behavioral and biological influences on premature birth, child health, and the trajectory of such approaches into adulthood.</text></subparagraph></paragraph></subsection></section><section id="H8960FB0DECC849A2A4F36034B3638DF8" commented="no" display-inline="no-display-inline" section-type="subsequent-section"><enum>703.</enum><header>Preventing maternal deaths</header><subsection id="H9C8BB4B71D3B4408A52F4F2ECDF21E7D"><enum>(a)</enum><header>Maternal mortality review committee</header><text display-inline="yes-display-inline">Section 317K(d) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-12">42 U.S.C. 247b–12(d)</external-xref>) is amended—</text><paragraph id="HC83C4D24E6F64038A5694A998B36029A"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1)(A), by inserting <quote>(including obstetricians and gynecologists)</quote> after <quote>clinical specialties</quote>; and</text></paragraph><paragraph id="H8C73A8389CB542C4AFF5742007BFCBB5"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (3)(A)(i)—</text><subparagraph id="HEB5614EB17034663A6CC1042C976030C"><enum>(A)</enum><text display-inline="yes-display-inline">in subclause (I), by striking <quote>as applicable</quote> and inserting <quote>if available</quote>; and</text></subparagraph><subparagraph id="HBDD16CFD07084C289559E20EDF39BE84"><enum>(B)</enum><text display-inline="yes-display-inline">in subclause (III), by striking <quote>, as appropriate</quote> and inserting <quote>and coordinating with death certifiers to improve the collection of death record reports and the quality of death records, including by amending cause-of-death information on a death certificate, as appropriate</quote>.</text></subparagraph></paragraph></subsection><subsection id="H7BF2BE6CB72A4EB4B279DD7FE36A7C63"><enum>(b)</enum><header>Best practices relating to the prevention of maternal mortality</header><text display-inline="yes-display-inline">Section 317K of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-12">42 U.S.C. 247b–12</external-xref>) is amended—</text><paragraph id="H0E31A6E6FD2341F78B7EA0C62404B830"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating subsections (e) and (f) as subsections (f) and (g), respectively; and</text></paragraph><paragraph id="H2E868C4A6556454093C8343464F7FCDB"><enum>(2)</enum><text display-inline="yes-display-inline">by inserting after subsection (d) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H6A7E0C975DC14BBE9B451C003149848F"><subsection id="H3F030BBDFF0949F48F194EEEEA607BB0"><enum>(e)</enum><header>Best practices relating to the prevention of maternal mortality</header><paragraph id="H89D921AA6470484BB80C3FA826A1400D"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, in consultation with the Administrator of the Health Resources and Services Administration, disseminate to hospitals, State professional society groups, and perinatal quality collaboratives, best practices on how to prevent maternal mortality and morbidity that consider and reflect best practices identified through other relevant Federal maternal health programs.</text></paragraph><paragraph id="H5391BF2E3E07458E9E5E682643ADD295"><enum>(2)</enum><header>Frequency</header><text display-inline="yes-display-inline">The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall disseminate the best practices referred to in paragraph (1) not less than once per fiscal year.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HEBAF44ADECF64D368C06729C10DCFD0F"><enum>(c)</enum><header>Extension</header><text display-inline="yes-display-inline">Subsection (g) of section 317K of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-12">42 U.S.C. 247b–12</external-xref>), as redesignated by subsection (b), is amended by striking <quote>$58,000,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$100,000,000 for each of fiscal years 2025 through 2029</quote>.</text></subsection></section><section id="H4341868CB9B7434BBEE3E2484B27B85A" commented="no"><enum>704.</enum><header>Sickle cell disease prevention and treatment</header><subsection id="HED2427CF31614665A209FFC5D95838F4" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1106(b) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300b-5">42 U.S.C. 300b–5(b)</external-xref>) is amended—</text><paragraph id="HDB4844F43F2C488381CB9389EAF77C05" commented="no"><enum>(1)</enum><text>in paragraph (1)(A)(iii), by striking <quote>prevention and treatment of sickle cell disease</quote> and inserting <quote>treatment of sickle cell disease and the prevention and treatment of complications of sickle cell disease</quote>;</text></paragraph><paragraph id="H864A9F42057145188515163F1B798B70" commented="no"><enum>(2)</enum><text>in paragraph (2)(D), by striking <quote>prevention and treatment of sickle cell disease</quote> and inserting <quote>treatment of sickle cell disease and the prevention and treatment of complications of sickle cell disease</quote>;</text></paragraph><paragraph id="H859EFCC957CA4488BD47A9FFFA2A6A2C" commented="no"><enum>(3)</enum><text>in paragraph (3)—</text><subparagraph id="HC417D564A59C4F53830850B76C7DE730" commented="no"><enum>(A)</enum><text>in subparagraph (A), by striking <quote>enter into a contract with</quote> and inserting <quote>make a grant to, or enter into a contract or cooperative agreement with,</quote>; and</text></subparagraph><subparagraph id="H86739BAA34ED45428D010C902F345649" commented="no"><enum>(B)</enum><text>in subparagraph (B), in each of clauses (ii) and (iii), by striking <quote>prevention and treatment of sickle cell disease</quote> and inserting <quote>treatment of sickle cell disease and the prevention and treatment of complications of sickle cell disease</quote>; and</text></subparagraph></paragraph><paragraph id="H35A09CD0D12645A2AAB26976B19C0D29" commented="no"><enum>(4)</enum><text>in paragraph (6), by striking <quote>$4,455,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$8,205,000 for each of fiscal years 2025 through 2029</quote>.</text></paragraph></subsection><subsection id="HAE372A3A11D24FE09C604D82FB54135A" commented="no"><enum>(b)</enum><header>Sense of Congress</header><text>It is the sense of Congress that further research should be undertaken to expand the understanding of the causes of, and to find cures for, heritable blood disorders, including sickle cell disease.</text></subsection></section><section id="H16DA0106C57F4529889DB8AB43F447E0"><enum>705.</enum><header>Traumatic brain injuries</header><subsection id="HDBC4C8958EF143D0AE7B1925F1BF6848"><enum>(a)</enum><header>The Bill Pascrell, Jr., national program for traumatic brain injury surveillance and registries</header><paragraph id="H4A3CD826B8854EC48604B777C7C4F507" commented="no" display-inline="no-display-inline"><enum>(1)</enum><header display-inline="yes-display-inline">Prevention of traumatic brain injury</header><text display-inline="yes-display-inline">Section 393B of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280b-1c">42 U.S.C. 280b–1c</external-xref>) is amended—</text><subparagraph id="H8BA877FDE99D4749AD05CA8C59D30E6B" commented="no" display-inline="no-display-inline"><enum>(A)</enum><text>in subsection (a), by inserting <quote>and prevalence</quote> after <quote>incidence</quote>;</text></subparagraph><subparagraph id="HE1FFDDA01ED74DF181323C613AF9A9C5" commented="no" display-inline="no-display-inline"><enum>(B)</enum><text>in subsection (b)—</text><clause id="HBB6DF63916454D1D87C71A34F62EFEDA" commented="no" display-inline="no-display-inline"><enum>(i)</enum><text>in paragraph (1), by inserting <quote>and reduction of associated injuries and fatalities</quote> before the semicolon;</text></clause><clause id="H0E052BD26EC54D7588F76DA8F8249E5E" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text>in paragraph (2), by inserting <quote>and related risk factors</quote> before the semicolon; and</text></clause><clause id="H4665F8890F774B4EBB8E8CC2FE3B25EB" commented="no" display-inline="no-display-inline"><enum>(iii)</enum><text>in paragraph (3)—</text><subclause id="H34D35DA091524292BD50DF2EF61EE042" commented="no" display-inline="no-display-inline"><enum>(I)</enum><text>in the matter preceding subparagraph (A), by striking <quote>2020</quote> each place it appears and inserting <quote>2030</quote>; and</text></subclause><subclause id="H3B4ED87BF0614E50A4FAD47568913A54" commented="no" display-inline="no-display-inline"><enum>(II)</enum><text>in subparagraph (A)—</text><item id="H4389F64FB9B746A8BD540E1D6B80DF26" commented="no" display-inline="no-display-inline"><enum>(aa)</enum><text>in clause (i), by striking <quote>; and</quote> and inserting a semicolon;</text></item><item id="H80A1857200844847B9F86DF6BD292CBF"><enum>(bb)</enum><text>by redesignating clause (ii) as clause (iv); </text></item><item id="H7B5C964A1BBE47DC9E563F637569CD7E" commented="no" display-inline="no-display-inline"><enum>(cc)</enum><text>by inserting after clause (i) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H164E974DF182416ABD86436574819CA8"><clause id="H07A860A47ACF4E0AB52AE2C9066843AF"><enum>(ii)</enum><text>populations at higher risk of traumatic brain injury, including populations whose increased risk is due to occupational or circumstantial factors; </text></clause><clause commented="no" display-inline="no-display-inline" id="H7922B36FE2584EF68E47F8176981287A"><enum>(iii)</enum><text display-inline="yes-display-inline">causes of, and risk factors for, traumatic brain injury; and</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></item><item id="H84BC8624724240D4B0E26CFDB4BF3ED1"><enum>(dd)</enum><text>in clause (iv), as so redesignated, by striking <quote>arising from traumatic brain injury</quote> and inserting <quote>, which may include related mental health and other conditions, arising from traumatic brain injury, including</quote>; and</text></item></subclause></clause></subparagraph><subparagraph id="H07F8D2518928437BB3DE1DFCCFCC5B87" commented="no" display-inline="no-display-inline"><enum>(C)</enum><text>in subsection (c), by inserting <quote>, and other relevant Federal departments and agencies</quote> before the period at the end.</text></subparagraph></paragraph><paragraph id="HF5E5A6FDF53B458689E344A24A202338" commented="no" display-inline="no-display-inline"><enum>(2)</enum><header>National program for traumatic brain injury surveillance and registries</header><text display-inline="yes-display-inline">Section 393C of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280b-1d">42 U.S.C. 280b–1d</external-xref>) is amended—</text><subparagraph id="H4BB9154F15CF4399A3F8E65AA11DCC11"><enum>(A)</enum><text>by amending the section heading to read as follows: <quote><header-in-text style="OLC" level="section">The Bill Pascrell, Jr., national program for traumatic brain injury surveillance and registries</header-in-text></quote>;</text></subparagraph><subparagraph id="H779675E6E94F4A149412F4E7645814A6" commented="no" display-inline="no-display-inline"><enum>(B)</enum><text display-inline="yes-display-inline">in subsection (a)—</text><clause id="HD4AA307036BD4A8F860A8975070E5AA7" commented="no" display-inline="no-display-inline"><enum>(i)</enum><text>in the matter preceding paragraph (1), by inserting <quote>to identify populations that may be at higher risk for traumatic brain injuries, to collect data on the causes of, and risk factors for, traumatic brain injuries,</quote> after <quote>related disability,</quote>; </text></clause><clause id="H42D5188AB8534BB89925BAE1C3E85870" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text display-inline="yes-display-inline">in paragraph (1), by inserting <quote>, including the occupation of the individual, when relevant to the circumstances surrounding the injury</quote> before the semicolon; and</text></clause><clause id="HF5D76EE25E2441938C9913A06D76827B" commented="no" display-inline="no-display-inline"><enum>(iii)</enum><text>in paragraph (4), by inserting <quote>short- and long-term</quote> before <quote>outcomes</quote>;</text></clause></subparagraph><subparagraph id="H928DD839CF9B49B8829B5C764C34F432" commented="no" display-inline="no-display-inline"><enum>(C)</enum><text>by striking subsection (b);</text></subparagraph><subparagraph id="H709CE9BAC59E4EC48A180AE681FCFDE3" commented="no" display-inline="no-display-inline"><enum>(D)</enum><text>by redesignating subsection (c) as subsection (b); </text></subparagraph><subparagraph id="H7B8F07A87BD648CD93FEC1C27724B7A9" commented="no" display-inline="no-display-inline"><enum>(E)</enum><text>in subsection (b), as so redesignated, by inserting <quote>and evidence-based practices to identify and address concussion</quote> before the period at the end; and </text></subparagraph><subparagraph id="H418D488491854C9CA3448BD367CDB14A" commented="no" display-inline="no-display-inline"><enum>(F)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H4764866AA4FC49E892A223A11F5A7128"><subsection id="HA56ED5B2DAD84E548CCD14A3E9253F09"><enum>(c)</enum><header>Availability of information</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall make publicly available aggregated information on traumatic brain injury and concussion described in this section, including on the website of the Centers for Disease Control and Prevention. Such website, to the extent feasible, shall include aggregated information on populations that may be at higher risk for traumatic brain injuries and strategies for preventing or reducing risk of traumatic brain injury that are tailored to such populations.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H5A7AA6388E674407AD8EAC8024D504CE" commented="no" display-inline="no-display-inline"><enum>(3)</enum><header>Authorization of appropriations</header><text>Section 394A of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280b-3">42 U.S.C. 280b–3</external-xref>) is amended—</text><subparagraph id="HF572EB568C984DF2AC73D18201387A38" commented="no" display-inline="no-display-inline"><enum>(A)</enum><text>in subsection (a), by striking <quote>1994, and</quote> and inserting <quote>1994,</quote>; and</text></subparagraph><subparagraph id="H68496790952B42E0B29F60A8C7A6ACC8" commented="no" display-inline="no-display-inline"><enum>(B)</enum><text>in subsection (b), by striking <quote>2020 through 2024</quote> and inserting <quote>2025 through 2029</quote>.</text></subparagraph></paragraph></subsection><subsection id="H323CFA2FFA044B238907C8EABCAB1E2D" display-inline="no-display-inline"><enum>(b)</enum><header>State grant programs</header><paragraph id="H99FEB40892994F50BB88FD9DACCF423F" commented="no" display-inline="no-display-inline"><enum>(1)</enum><header display-inline="yes-display-inline">State grants for projects regarding traumatic brain injury</header><text display-inline="yes-display-inline">Section 1252 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300d-52">42 U.S.C. 300d–52</external-xref>) is amended—</text><subparagraph id="HEEF77BDF3DB448BBA76B5F76A7FA9E81" commented="no" display-inline="no-display-inline"><enum>(A)</enum><text>in subsection (b)(2)—</text><clause id="HE8EBF1ABF1CA4700AEB17E36684D68AD"><enum>(i)</enum><text>by inserting <quote>, taking into consideration populations that may be at higher risk for traumatic brain injuries</quote> after <quote>outreach programs</quote>; and</text></clause><clause id="H163F1B6951024753B109BF772BF0C4F6" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text>by inserting <quote>Tribal,</quote> after <quote>State,</quote>;</text></clause></subparagraph><subparagraph id="H9ED40AF44A9B44938701D245A1DA90FE" commented="no" display-inline="no-display-inline"><enum>(B)</enum><text>in subsection (c), by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H895492C602FB446194A63D1C04E52231"><paragraph id="H6D5F379CB25D41158B96A511C8FD7AC6"><enum>(3)</enum><header>Maintenance of effort</header><text>With respect to activities for which a grant awarded under subsection (a) is to be expended, a State or American Indian consortium shall agree to maintain expenditures of non-Federal amounts for such activities at a level that is not less than the level of such expenditures maintained by the State or American Indian consortium for the fiscal year preceding the fiscal year for which the State or American Indian consortium receives such a grant.</text></paragraph><paragraph id="HF5245A58493F4FA996BD503BD42FC987"><enum>(4)</enum><header>Waiver</header><text>The Secretary may, upon the request of a State or American Indian consortium, waive not more than 50 percent of the matching fund amount under paragraph (1), if the Secretary determines that such matching fund amount would result in an inability of the State or American Indian consortium to carry out the purposes under subsection (a). A waiver provided by the Secretary under this paragraph shall apply only to the fiscal year involved.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="H2E903B14C1784F6A8302CC5966EA928E" commented="no" display-inline="no-display-inline"><enum>(C)</enum><text display-inline="yes-display-inline">in subsection (e)(3)(B)—</text><clause id="HCDFA9372237842698ADA8C33BAD61FFD" commented="no" display-inline="no-display-inline"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>(such as third party payers, State agencies, community-based providers, schools, and educators)</quote>; and</text></clause><clause id="H1ACBF6656CBE4F3389013253BDBA16DF" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text>by inserting <quote>(such as third party payers, State agencies, community-based providers, schools, and educators)</quote> after <quote>professionals</quote>;</text></clause></subparagraph><subparagraph id="HEB26DCF283D7462D9AAAB942492CB702" commented="no" display-inline="no-display-inline"><enum>(D)</enum><text>in subsection (h), by striking paragraphs (1) and (2) and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HD931D852DDFE4EEFAF2754AFFF821982"><paragraph id="HA95E6E20A2FD4BE395213D4A80640C66"><enum>(1)</enum><header>American Indian consortium; State</header><text>The terms <term>American Indian consortium</term> and <term>State</term> have the meanings given such terms in section 1253.</text></paragraph><paragraph id="H578A9F0AA7A9453F8D1AAEB2FCCEAF55"><enum>(2)</enum><header>Traumatic brain injury</header><subparagraph commented="no" display-inline="no-display-inline" id="H8D989D6FF8BF4A0E8AC170C22EB9B903"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Subject to subparagraph (B), the term <term>traumatic brain injury</term>—</text><clause commented="no" display-inline="no-display-inline" id="H901DE3DB384D460485A3915946592CB5"><enum>(i)</enum><text display-inline="yes-display-inline">means an acquired injury to the brain; </text></clause><clause commented="no" display-inline="no-display-inline" id="H7F09E1476F214F4FBAA5B640C714B53D"><enum>(ii)</enum><text display-inline="yes-display-inline">may include—</text><subclause commented="no" display-inline="no-display-inline" id="HC15B41F4CC2847F3B27FD5C95766DB96"><enum>(I)</enum><text display-inline="yes-display-inline">brain injuries caused by anoxia due to trauma; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HBCA9B743E5054DC880F92D6A34E61D35"><enum>(II)</enum><text display-inline="yes-display-inline">damage to the brain from an internal or external source that results in infection, toxicity, surgery, or vascular disorders not associated with aging; and</text></subclause></clause><clause commented="no" display-inline="no-display-inline" id="H9EB7658912544848BD08DCD65C03DD7B"><enum>(iii)</enum><text>does not include brain dysfunction caused by congenital or degenerative disorders, or birth trauma.</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF8751255D724423FB1168A31C62BD205"><enum>(B)</enum><header>Revisions to definition</header><text display-inline="yes-display-inline">The Secretary may revise the definition of the term <term>traumatic brain injury</term> under this paragraph, as the Secretary determines necessary, after consultation with States and other appropriate public or nonprofit private entities.</text></subparagraph></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph id="HE42F64C475194DA9BF1BDDE35A0F42A3" commented="no" display-inline="no-display-inline"><enum>(E)</enum><text>in subsection (i), by striking <quote>2020 through 2024</quote> and inserting <quote>2025 through 2029</quote>.</text></subparagraph></paragraph><paragraph id="H034B525AB3D04A098F2D291F4F2D934D"><enum>(2)</enum><header>State grants for protection and advocacy services</header><text>Section 1253(l) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300d-53">42 U.S.C. 300d–53(l)</external-xref>) is amended by striking <quote>2020 through 2024</quote> and inserting <quote>2025 through 2029</quote>.</text></paragraph></subsection><subsection id="HFC21D7C06A794E289FF11E1F17134DB1" display-inline="no-display-inline"><enum>(c)</enum><header>Report to Congress</header><text>Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this Act as the <quote>Secretary</quote>) shall 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 contains—</text><paragraph id="H458A2F955A4F4421B4E182176F58B7E2" commented="no" display-inline="no-display-inline"><enum>(1)</enum><text display-inline="yes-display-inline">an overview of populations who may be at higher risk for traumatic brain injury, such as individuals affected by domestic violence or sexual assault and public safety officers as defined in section 1204 of the Omnibus Crime Control and Safe Streets Act of 1968 (<external-xref legal-doc="usc" parsable-cite="usc/34/10284">34 U.S.C. 10284</external-xref>);</text></paragraph><paragraph id="H129FF04E99BA49D4ADE61F25FEFDB908" commented="no" display-inline="no-display-inline"><enum>(2)</enum><text display-inline="yes-display-inline">an outline of existing surveys and activities of the Centers for Disease Control and Prevention on traumatic brain injuries and any steps the agency has taken to address gaps in data collection related to such higher risk populations, which may include leveraging surveys such as the National Intimate Partner and Sexual Violence Survey to collect data on traumatic brain injuries;</text></paragraph><paragraph id="HAF1F360920BB47339842236EEC1B9151" commented="no" display-inline="no-display-inline"><enum>(3)</enum><text display-inline="yes-display-inline">an overview of any outreach or education efforts to reach such higher risk populations; and</text></paragraph><paragraph id="HCB12912D5FCF4E75A4E31923186891FE" commented="no" display-inline="no-display-inline"><enum>(4)</enum><text display-inline="yes-display-inline">any challenges associated with reaching such higher risk populations. </text></paragraph></subsection><subsection id="H3491F3494EA64EC4B8F7FF16A9C52D9A" display-inline="no-display-inline"><enum>(d)</enum><header>Study on long-Term symptoms or conditions related to traumatic brain injury</header><paragraph id="H0545048EDE4446DB835FB1534068D9CA"><enum>(1)</enum><header>In general</header><text>The Secretary, in consultation with stakeholders and the heads of other relevant Federal departments and agencies, as appropriate, shall conduct, either directly or through a contract with a nonprofit private entity, a study to—</text><subparagraph id="HE37287A84BCB42478CAFC4859791E3A1"><enum>(A)</enum><text>examine the incidence and prevalence of long-term or chronic symptoms or conditions in individuals who have experienced a traumatic brain injury;</text></subparagraph><subparagraph id="HCFF440F6610B422DAEBE56A31CA44E6A"><enum>(B)</enum><text>examine the evidence base of research related to the chronic effects of traumatic brain injury across the lifespan;</text></subparagraph><subparagraph id="HB406248BBCBA43B7B7FB3A67EA004066"><enum>(C)</enum><text>examine any correlations between traumatic brain injury and increased risk of other conditions, such as dementia and mental health conditions;</text></subparagraph><subparagraph id="HEACD84A281B84771B0528FCD12430609"><enum>(D)</enum><text>assess existing services available for individuals with such long-term or chronic symptoms or conditions; and</text></subparagraph><subparagraph id="H6CFE0374AC824DE78F3EEE75A2FF6928"><enum>(E)</enum><text>identify any gaps in research related to such long-term or chronic symptoms or conditions of individuals who have experienced a traumatic brain injury.</text></subparagraph></paragraph><paragraph id="H1E20D1643C62417DA89C2ABA78B152E9"><enum>(2)</enum><header>Public report</header><text>Not later than 2 years after the date of enactment of this Act, the Secretary shall—</text><subparagraph id="H5F069A9875DF4C5E88DC47225CB84424" commented="no" display-inline="no-display-inline"><enum>(A)</enum><text>submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report detailing the findings, conclusions, and recommendations of the study described in paragraph (1); and</text></subparagraph><subparagraph id="HAA363C46DD784CEEB9381C6F2723A885" commented="no" display-inline="no-display-inline"><enum>(B)</enum><text display-inline="yes-display-inline">in the case that such study is conducted directly by the Secretary, make the report described in subparagraph (A) publicly available on the website of the Department of Health and Human Services.</text></subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H10FF4783D8A84EEE81A5ED0BAF06D268"><enum>706.</enum><header>Lifespan respite care</header><subsection commented="no" display-inline="no-display-inline" id="H3F5027B8AC494026A70CA5F91FE69227"><enum>(a)</enum><header display-inline="yes-display-inline">Definition of family caregiver</header><text>Section 2901(5) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300ii">42 U.S.C. 300ii(5)</external-xref>) is amended by striking <quote>unpaid adult</quote> and inserting <quote>unpaid individual</quote>.</text></subsection><subsection id="H935E0C20FF514754BA8B447FB788FA39"><enum>(b)</enum><header>Funding</header><text>Section 2905 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300ii-4">42 U.S.C. 300ii–4</external-xref>) is amended by striking <quote>fiscal years 2020 through fiscal year 2024</quote> and inserting <quote>fiscal years 2025 through 2029</quote>.</text></subsection></section><section id="HF61226C6354C463FA3A7CA1B1C701C4E"><enum>707.</enum><header>Dr. Lorna Breen health care provider protection</header><subsection id="HA0AEFA1F20CA42E3A4DA9014BCFBE121" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(a)</enum><header>Dissemination of best practices</header><text>Section 2 of the Dr. Lorna Breen Health Care Provider Protection Act (<external-xref legal-doc="public-law" parsable-cite="pl/117/105">Public Law 117–105</external-xref>) is amended by striking <quote>2 years</quote> and inserting <quote>5 years</quote>.</text></subsection><subsection id="H6F199FBC178A45999DFE1817B1BD493C" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(b)</enum><header display-inline="yes-display-inline">Education and awareness initiative encouraging use of mental health and substance use disorder services by health care professionals</header><text>Section 3 of the Dr. Lorna Breen Health Care Provider Protection Act (<external-xref legal-doc="public-law" parsable-cite="pl/117/105">Public Law 117–105</external-xref>) is amended—</text><paragraph id="H4A3DDB16A53C439182397A58418E6EC6" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(1)</enum><text>in subsection (b), by inserting <quote>and annually thereafter,</quote> after <quote>of this Act,</quote>; and</text></paragraph><paragraph id="HB69F40EC221841039D5BA76E6B6E28B1" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(2)</enum><text>in subsection (c), by striking <quote>2022 through 2024</quote> and inserting <quote>2025 through 2029</quote>.</text></paragraph></subsection><subsection id="HEC8560F63FCA4937AE5FDEC37325A161" changed="not-changed" display-inline="no-display-inline"><enum>(c)</enum><header>Programs To promote mental health among the health professional workforce</header><text>The second section 764 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/294t">42 U.S.C. 294t</external-xref>), as added by section 4 of the Dr. Lorna Breen Health Care Provider Protection Act (<external-xref legal-doc="public-law" parsable-cite="pl/117/105">Public Law 117–105</external-xref>), is amended—</text><paragraph id="HD76C738A4DC742B3B9610A27AD313943" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(1)</enum><text>by redesignating such section 764 as section 764A;</text></paragraph><paragraph id="H9CDA8CE5B0EA4EC29F23D2A8262A7A00" changed="not-changed"><enum>(2)</enum><text>in subsection (a)(3)—</text><subparagraph id="H90207AB212204EEA9CD2B52F355B0314" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>to eligible entities in</quote> and inserting “to eligible entities that—</text><quoted-block style="OLC" display-inline="no-display-inline" id="H07C246E0B27742EAAA5EB8D28AE93790" changed="not-changed"><subparagraph id="H9593843D4DBE4D1E81E77931B50232AA" changed="not-changed"><enum>(A)</enum><text>are in</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="H64C429A41F724AC2AF845171D27319D9" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(B)</enum><text>by striking the period and inserting <quote>; or</quote>; and</text></subparagraph><subparagraph id="HAA0187B8C7174E6AA18F25AE74D9B61F" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(C)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HE93AF598D830459A81841FA68FFD2FFB" changed="not-changed"><subparagraph id="H78B031718A8744FEBAC2F66AFADDC4F1" changed="not-changed"><enum>(B)</enum><text>have a focus on the reduction of administrative burden on health care workers.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H84D44C791EFD409B8A4479DBFFF86D3E" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (c), by inserting <quote>not less than</quote> after <quote>period of</quote>; and</text></paragraph><paragraph id="H490534D2A52044BAA42864F85A90923A" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(4)</enum><text>in subsection (f), by striking <quote>2022 through 2024</quote> and inserting <quote>2025 through 2029</quote>.</text></paragraph></subsection></section><section id="H4503103C0E05445FA76A2F6D597497F3"><enum>708.</enum><header>Conforming amendment to Internal Revenue Code of 1986</header><text display-inline="no-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/9008">Section 9008(i)(2)</external-xref> of the Internal Revenue Code of 1986 (<external-xref legal-doc="usc" parsable-cite="usc/26/9008">26 U.S.C. 9008(i)(2)</external-xref>) is amended by striking <quote>10–Year</quote>.</text></section><section id="H19A48980167548618F08FC0A61BD8B86"><enum>709.</enum><header>SCREENS for Cancer</header><subsection id="H87583A3248E54C83B1BCAC0D35D00E17" display-inline="no-display-inline"><enum>(a)</enum><header>National Breast and Cervical Cancer Early Detection Program</header><text>Title XV of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300k">42 U.S.C. 300k et seq.</external-xref>) is amended—</text><paragraph id="H7D2A5424DD844DDDBAD4F69F417593D0"><enum>(1)</enum><text>in section 1501 (<external-xref legal-doc="usc" parsable-cite="usc/42/300k">42 U.S.C. 300k</external-xref>)—</text><subparagraph id="H4B29728A5B6040CF819A0CEEE8EA9029"><enum>(A)</enum><text>in subsection (a)—</text><clause id="HE012A237437E47989435181EF7940910"><enum>(i)</enum><text>in paragraph (2), by striking <quote>the provision of appropriate follow-up services and support services such as case management</quote> and inserting <quote>that appropriate follow-up services are provided</quote>;</text></clause><clause id="H36BD08A1437848D9B0097E4C1E28CFF2"><enum>(ii)</enum><text>in paragraph (3), by striking <quote>programs for the detection and control</quote> and inserting <quote>for the prevention, detection, and control</quote>;</text></clause><clause id="HAF6B6D3EB7F045088619A8C97BE32905"><enum>(iii)</enum><text>in paragraph (4), by striking <quote>the detection and control</quote> and inserting <quote>the prevention, detection, and control</quote>;</text></clause><clause id="HEB56815F897943F6B8B61A74A0729685"><enum>(iv)</enum><text>in paragraph (5)—</text><subclause id="H85D9E2A5C185427DB09BCAFB76751A78"><enum>(I)</enum><text>by striking <quote>monitor</quote> and inserting <quote>ensure</quote>; and</text></subclause><subclause id="HD7A02117B38040CD82F540E68FC7AB5D"><enum>(II)</enum><text>by striking <quote>; and</quote> and inserting a semicolon;</text></subclause></clause><clause id="H1D368C456B2C4FA7846998BF3130D237"><enum>(v)</enum><text>by redesignating paragraph (6) as paragraph (9); </text></clause><clause id="H64CEA96473904761975DD61B0D4A4CFB"><enum>(vi)</enum><text>by inserting after paragraph (5) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H39A08BBA74EB434D818BDCCCD291CB1A"><paragraph id="HFE98C4FBB0A541CF88AB5C1BF51C007B"><enum>(6)</enum><text>to enhance appropriate support activities to increase breast and cervical cancer screenings, such as navigation of health care services, implementation of evidence-based or evidence-informed strategies to increase breast and cervical cancer screening in health care settings, and facilitation of access to health care settings; </text></paragraph><paragraph id="H784071A386634B5FAE41AE28BB418CC8"><enum>(7)</enum><text>to reduce disparities in breast and cervical cancer incidence, morbidity, and mortality, including in populations with higher than average rates; </text></paragraph><paragraph id="HB6FABDD98BF54472975692765BA65827"><enum>(8)</enum><text>to improve access to breast and cervical cancer screening and diagnostic services and reduce related barriers, including factors that relate to negative health outcomes; and</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause><clause id="HC5CC110C45AC48B3B1EA23715EAFD80B"><enum>(vii)</enum><text>in paragraph (9), as so redesignated, by striking <quote>through (5)</quote> and inserting <quote>through (8)</quote>; and</text></clause></subparagraph><subparagraph id="H57CC3FCED8F14F6282E533BF0F3FB8D9" commented="no"><enum>(B)</enum><text>by striking subsection (d);</text></subparagraph></paragraph><paragraph id="H8F82C18050B047CC8F76F5F88F9408B4"><enum>(2)</enum><text>in section 1503 (<external-xref legal-doc="usc" parsable-cite="usc/42/300m">42 U.S.C. 300m</external-xref>)—</text><subparagraph id="HE891E975F6B340808B2A611ACC5B7891"><enum>(A)</enum><text>in subsection (a)—</text><clause id="H4158C83365D140C3A0370AC3E6F9AE04"><enum>(i)</enum><text>in paragraph (1), by striking <quote>that, initially</quote> and all that follows through the semicolon and inserting <quote>that appropriate breast and cervical cancer screening and diagnostic services are provided consistent with relevant evidence-based recommendations; and</quote>;</text></clause><clause id="H1F19D737CCB440CFBF3B6E8C513E656F"><enum>(ii)</enum><text>by striking paragraphs (2) and (4);</text></clause><clause id="H908163DC8BCD4387897B47123B4C3AA6"><enum>(iii)</enum><text>by redesignating paragraph (3) as paragraph (2); and</text></clause><clause id="H7415718985B440918099063BF080A022"><enum>(iv)</enum><text>in paragraph (2), as so redesignated, by striking <quote>; and</quote> and inserting a period; and</text></clause></subparagraph><subparagraph id="H0B197B3D256748169981D1B92E741BE6"><enum>(B)</enum><text>by striking subsection (d);</text></subparagraph></paragraph><paragraph id="HF4BCC294B52140329C77AE6F1BC3DAB1"><enum>(3)</enum><text>in section 1508(b) (<external-xref legal-doc="usc" parsable-cite="usc/42/300n-4">42 U.S.C. 300n–4(b)</external-xref>)—</text><subparagraph id="H99574DE97F4849CAA51EA1C08717DAED"><enum>(A)</enum><text>by striking <quote>1 year after the date of the enactment of the National Breast and Cervical Cancer Early Detection Program Reauthorization of 2007, and annually thereafter,</quote> and inserting <quote>2 years after the date of enactment of the Health Improvements, Extenders, and Reauthorizations Act, and every 5 years thereafter,</quote>; </text></subparagraph><subparagraph id="H8B9BF554F93C44A4B3998F7F564D6E86"><enum>(B)</enum><text>by striking <quote>Labor and Human Resources</quote> and inserting <quote>Health, Education, Labor, and Pensions</quote>; and </text></subparagraph><subparagraph id="H3EF609B627074300A37253720E1FC38D"><enum>(C)</enum><text>by striking <quote>preceding fiscal year</quote> and inserting <quote>preceding 2 fiscal years in the case of the first report after the date of enactment of the Health Improvements, Extenders, and Reauthorizations Act and preceding 5 fiscal years for each report thereafter</quote>; and</text></subparagraph></paragraph><paragraph id="H8709A49E0AEB416A9C401476F1469792"><enum>(4)</enum><text>in section 1510(a) (<external-xref legal-doc="usc" parsable-cite="usc/42/300n-5">42 U.S.C. 300n–5(a)</external-xref>)—</text><subparagraph id="H920F68FD37F74EABB655712899B9073D" commented="no" display-inline="no-display-inline"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>2011, and</quote> and inserting <quote>2011,</quote>; and</text></subparagraph><subparagraph id="H13EBA6C0348A46B3B81CE135B1AE6BEE" commented="no" display-inline="no-display-inline"><enum>(B)</enum><text display-inline="yes-display-inline">by inserting <quote>, and $235,500,000 for each of fiscal years 2025 through 2029</quote> before the period at the end before the period at the end.</text></subparagraph></paragraph></subsection><subsection id="H842D8E220B1745779C8E0D47064662A5" display-inline="no-display-inline"><enum>(b)</enum><header>GAO study</header><text>Not later than September 30, 2027, the Comptroller General of the United States shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the work of the National Breast and Cervical Cancer Early Detection Program, including— </text><paragraph id="HD6372BCE390841CFA276D5A260ECB1BF"><enum>(1)</enum><text>an estimate of the number of individuals eligible for services provided under such program; </text></paragraph><paragraph id="H1CA3240336FE45ECA1C146BFBE8B6B90"><enum>(2)</enum><text>a summary of trends in the number of individuals served through such program; and</text></paragraph><paragraph id="HB48A8E26D5394D2CA1AB10B69FCA1991"><enum>(3)</enum><text>an assessment of any factors that may be driving the trends identified under paragraph (2), including any barriers to accessing breast and cervical cancer screenings provided by such program.</text></paragraph></subsection></section><section id="H62BAF318FEA94BA5AC99939E0544BB75"><enum>710.</enum><header>DeOndra Dixon INCLUDE Project</header><text display-inline="no-display-inline">Part B of title IV of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/284">42 U.S.C. 284 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block id="H74347333D2FB4A77B2EFE3BF9B78F099" style="OLC"><section id="HF4A2D31F1B65471781BF3693506E0194" commented="no"><enum>409K.</enum><header>Down syndrome research</header><subsection id="H9D0BCAF628024A61BBB49DDA0154FB28" commented="no"><enum>(a)</enum><header>In general</header><text>The Director of NIH shall carry out a program of research, training, and investigation related to Down syndrome to be known as the <quote>INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE Project</quote> or the <quote>INCLUDE Project</quote>.</text></subsection><subsection id="H662C4A2BBF874C0BAC06B42AF6EAAF16" commented="no"><enum>(b)</enum><header>Program elements</header><text>The program under subsection (a) shall include—</text><paragraph id="H00B9550E590C4F6AA7429428C3F7DABC" commented="no"><enum>(1)</enum><text>high-risk, high reward research on the effects of trisomy 21 on human development and health;</text></paragraph><paragraph id="H11CA54F9E61A4EF2AE0441CF6C9A9C2B" commented="no"><enum>(2)</enum><text>promoting research for participants with Down syndrome across the lifespan, including cohort studies to facilitate improved understanding of Down syndrome and co-occurring conditions and development of new interventions;</text></paragraph><paragraph id="H339636F0310A4C6ABAA1E4A820E5278F" commented="no"><enum>(3)</enum><text>expanding the number of clinical trials that are inclusive of, or expressly for, participants with Down syndrome, including novel biomedical and pharmacological interventions and other therapies designed to promote or enhance activities of daily living;</text></paragraph><paragraph id="H846D702A111D4C72B464FC19A004FB22" commented="no"><enum>(4)</enum><text>research on the biological mechanisms in individuals with Down syndrome pertaining to structural, functional, and behavioral anomalies and dysfunction as well as stunted growth;</text></paragraph><paragraph id="HEF0601431A33411B9FEF5F37E1911BA1" commented="no"><enum>(5)</enum><text>supporting research to improve diagnosis and treatment of conditions co-occurring with Down syndrome, including the identification of biomarkers related to risk factors, diagnosis, and clinical research and therapeutics;</text></paragraph><paragraph id="HDB05B80701364D47A81BAFA7307ADD2C" commented="no"><enum>(6)</enum><text>research on the causes of increased prevalence, and concurrent treatment, of co-occurring conditions, such as Alzheimer’s disease and related dementias and autoimmunity, in individuals with Down syndrome; and</text></paragraph><paragraph id="H0481F5DA1CAD4887923898D4B3DA89CC" commented="no"><enum>(7)</enum><text display-inline="yes-display-inline">research, training, and investigation on improving the quality of life of individuals with Down syndrome and their families.</text></paragraph></subsection><subsection id="HA9D6015B0DC443E0872381682EB402F2" commented="no"><enum>(c)</enum><header>Coordination; Prioritizing nonduplicative research</header><text>The Director of NIH shall ensure that—</text><paragraph id="HC649FDA5766A46399C7B78A5CA7D81E5" commented="no"><enum>(1)</enum><text>the programs and activities of the institutes and centers of the National Institutes of Health relating to Down syndrome and co-occurring conditions are coordinated, including through the Office of the Director of NIH and priority-setting reviews conducted pursuant to section 402(b)(3); and</text></paragraph><paragraph id="H98A6FF1A212B47329AFDCED4F35661FD" commented="no"><enum>(2)</enum><text>such institutes and centers, prioritize, as appropriate, Down syndrome research that does not duplicate existing research activities of the National Institutes of Health.</text></paragraph></subsection><subsection id="H650FD73D347446CB8597DE349011B5B7" commented="no"><enum>(d)</enum><header>Consultation with stakeholders</header><text>In carrying out activities under this section, the Director of NIH shall, as appropriate and to the maximum extent feasible, consult with relevant stakeholders, including patient advocates, to ensure that such activities take into consideration the needs of individuals with Down syndrome.</text></subsection><subsection id="H69174C84E2C14116A24240328D477372" commented="no"><enum>(e)</enum><header>Biennial reports to Congress</header><paragraph id="H1C66C07598CD462492FFC396A0282D8E" commented="no"><enum>(1)</enum><header>In general</header><text>The Director of NIH shall submit, on a biennial basis, to the Committee on Energy and Commerce and the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies of the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies of the Committee on Appropriations of the Senate, a report that catalogs the research conducted or supported under this section.</text></paragraph><paragraph id="H4E7D6E1FE06B41D4895B07F7DD468597" commented="no"><enum>(2)</enum><header>Contents</header><text>Each report under paragraph (1) shall include—</text><subparagraph id="HA200E01E8E234E499CA63A18E6726269" commented="no"><enum>(A)</enum><text>identification of the institute or center involved;</text></subparagraph><subparagraph id="H794266667E6D4388A57B41C4A21C0DFC" commented="no"><enum>(B)</enum><text>a statement of whether the research is or was being carried out directly by such institute or center or by multiple institutes and centers; and</text></subparagraph><subparagraph id="H5E949F4DFBF447E1B9A71868750B0C8A" commented="no"><enum>(C)</enum><text>identification of any resulting real-world evidence that is or may be used for clinical research and medical care for patients with Down syndrome.</text></subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="H26C7484E91FE468A848486BAF05D3898"><enum>711.</enum><header>IMPROVE Initiative</header><text display-inline="no-display-inline">Part B of title IV of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/284">42 U.S.C. 284 et seq.</external-xref>), as amended by section 710, is further amended by adding at the end the following:</text><quoted-block id="HBD624B6C5F724A9D8EADFA6A80928459" style="OLC"><section id="HAA6A1723FEE04AD99FBB2C3E4A557A0C"><enum>409L.</enum><header>IMPROVE initiative</header><subsection id="HC2E3E9605D9D492F81FF6BB256A283F1"><enum>(a)</enum><header>In general</header><text>The Director of the National Institutes of Health shall carry out a program of research to improve health outcomes to be known as the Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone Initiative (referred to in this section as the <quote>Initiative</quote>).</text></subsection><subsection id="H0704474ED4134CE3883EF4BAD2E132D5"><enum>(b)</enum><header>Objectives</header><text>The Initiative shall—</text><paragraph id="HD6545E65664B4246882C6E28721EE0FF"><enum>(1)</enum><text>advance research to—</text><subparagraph id="H9562EB34109B40CE9FF53ECC5AC16B1F"><enum>(A)</enum><text>reduce preventable causes of maternal mortality and severe maternal morbidity;</text></subparagraph><subparagraph id="HEF80E747044546148156BDE5D4C8F7B0"><enum>(B)</enum><text>reduce health disparities related to maternal health outcomes, including such disparities associated with medically underserved populations; and</text></subparagraph><subparagraph id="HFD57C319AFF249D0A6BB121489B0E68A"><enum>(C)</enum><text>improve health for pregnant and postpartum women before, during, and after pregnancy;</text></subparagraph></paragraph><paragraph id="HEFF48967E4A945D1A92C334039E33EF4"><enum>(2)</enum><text>use an integrated approach to understand the factors, including biological, behavioral, and other factors, that affect maternal mortality and severe maternal morbidity by building an evidence base for improved outcomes in specific regions of the United States; and</text></paragraph><paragraph id="H8D69C7E29B9A4761B31DBE8773D36BB0"><enum>(3)</enum><text>target health disparities associated with maternal mortality and severe maternal morbidity by—</text><subparagraph id="H10E54F04A8A04535997A394C2973F8A1"><enum>(A)</enum><text>implementing and evaluating community-based interventions for disproportionately affected women; and</text></subparagraph><subparagraph id="H62DA57189AE3492D899E653D2EF5E185"><enum>(B)</enum><text>identifying risk factors and the underlying biological mechanisms associated with leading causes of maternal mortality and severe maternal morbidity in the United States.</text></subparagraph></paragraph></subsection><subsection id="H18EC39C3462F4064BB941FA1CAECAB72"><enum>(c)</enum><header>Sunset</header><text>The authority under this section shall expire on September 30, 2029.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="HDCFFAB230FA04A798E8263BB02EB758B"><enum>712.</enum><header>Organ Procurement and Transplantation Network</header><text display-inline="no-display-inline">Section 372 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/274">42 U.S.C. 274</external-xref>) is amended—</text><paragraph id="HCA20D4A9790A46ABA572E34D65FA2E6D"><enum>(1)</enum><text>in subsection (b)(2)—</text><subparagraph id="H807C9688D9904D739475573F4CD1D0DE"><enum>(A)</enum><text>by moving the margins of subparagraphs (M) through (O) 2 ems to the left;</text></subparagraph><subparagraph id="H4EFBF22FE77C4857A8ADC091B53BB9CF"><enum>(B)</enum><text>in subparagraph (A)—</text><clause id="H050F80BC33B44D9794C60F163E27C715"><enum>(i)</enum><text>in clause (i), by striking <quote>, and</quote> and inserting <quote>; and</quote>; and</text></clause><clause id="HD3E803B7695D4B009D39A935D860C489"><enum>(ii)</enum><text>in clause (ii), by striking the comma at the end and inserting a semicolon;</text></clause></subparagraph><subparagraph id="H45F32DDB0F704B23A97A53730897E2B7"><enum>(C)</enum><text>in subparagraph (C), by striking <quote>twenty-four-hour telephone service</quote> and inserting <quote>24-hour telephone or information technology service</quote>;</text></subparagraph><subparagraph id="H96AB9156F5B74D91931BD74E1AB80897"><enum>(D)</enum><text>in each of subparagraphs (B) through (M), by striking the comma at the end and inserting a semicolon;</text></subparagraph><subparagraph id="HD8EDF7A6BD284505A28FA1313626CCDE"><enum>(E)</enum><text>in subparagraph (N), by striking <quote>transportation, and</quote> and inserting <quote>transportation;</quote>;</text></subparagraph><subparagraph id="H3545077F72D340B7BAFA838E61858F38"><enum>(F)</enum><text>in subparagraph (O), by striking the period and inserting a semicolon; and</text></subparagraph><subparagraph id="H8C65D66725FE436C842E018D24449A90"><enum>(G)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HC6FD68C1599B41EE8DA52F3AE7E0CBC5"><subparagraph id="H48BD320FBE044D0B91F74BB5F9DC5A08"><enum>(P)</enum><text>encourage the integration of electronic health records systems through application programming interfaces (or successor technologies) among hospitals, organ procurement organizations, and transplant centers, including the use of automated electronic hospital referrals and the grant of remote, electronic access to hospital electronic health records of potential donors by organ procurement organizations, in a manner that complies with the privacy regulations promulgated under the Health Insurance Portability and Accountability Act of 1996, at part 160 of title 45, Code of Federal Regulations, and subparts A, C, and E of part 164 of such title (or any successor regulations); and</text></subparagraph><subparagraph id="H911D72CF8AAC44B3963243A5C8D1598B"><enum>(Q)</enum><text>consider establishing a dashboard to display the number of transplants performed, the types of transplants performed, the number and types of organs that entered the Organ Procurement and Transplantation Network system and failed to be transplanted, and other appropriate statistics, which should be updated more frequently than annually.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H6614090449784BD7AFD0908925220A07"><enum>(2)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" id="H5AA28E843B414EBAB5A710E77EB409B1" display-inline="no-display-inline"><subsection id="HD524211F05A8457E87FC074905AF49D4"><enum>(d)</enum><header>Registration fees</header><paragraph id="HF2EFB9817FF14532ABF09FBB530EC764"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary may collect registration fees from any member of the Organ Procurement and Transplantation Network for each transplant candidate such member places on the list described in subsection (b)(2)(A)(i). Such registration fees shall be collected and distributed only to support the operation of the Organ Procurement and Transplantation Network. Such registration fees are authorized to remain available until expended.</text></paragraph><paragraph id="H0797C9CA34934B9E8568237377B50843"><enum>(2)</enum><header>Collection</header><text>The Secretary may collect the registration fees under paragraph (1) directly or through awards made under subsection (b)(1)(A).</text></paragraph><paragraph id="HD60994FAC8D0417A9DC7FBE7821362B5"><enum>(3)</enum><header>Distribution</header><text>Any amounts collected under this subsection shall—</text><subparagraph id="H092C1DF2483C4100B01CF4013ADBB865"><enum>(A)</enum><text>be credited to the currently applicable appropriation, account, or fund of the Department of Health and Human Services as discretionary offsetting collections; and</text></subparagraph><subparagraph id="HB63A16B1100745D7AE9117DB3DC9F709"><enum>(B)</enum><text>be available, only to the extent and in the amounts provided in advance in appropriations Acts, to distribute such fees among awardees described in subsection (b)(1)(A).</text></subparagraph></paragraph><paragraph id="H0FDDA6303A574E1E8586D94C095A69C7"><enum>(4)</enum><header>Transparency</header><text>The Secretary shall—</text><subparagraph id="H28A651B0767C45ADA402ABE1D887083D"><enum>(A)</enum><text>promptly post on the website of the Organ Procurement and Transplantation Network—</text><clause id="HFC1224908F994F76AFA3FEF34D2D2C6A"><enum>(i)</enum><text>the amount of registration fees collected under this subsection from each member of the Organ Procurement and Transplantation Network; and</text></clause><clause id="H1D619340B80C4DA0BAAB59E3CB6C51F6"><enum>(ii)</enum><text>a list of activities such fees are used to support; and</text></clause></subparagraph><subparagraph id="H6DE01E00438F450686D91FE9C895C85A"><enum>(B)</enum><text>update the information posted pursuant to subparagraph (A), as applicable for each calendar quarter for which fees are collected under paragraph (1).</text></subparagraph></paragraph><paragraph id="H1286A57375064E75AF54EB9C234BADD0"><enum>(5)</enum><header>GAO review</header><text>Not later than 2 years after the date of enactment of this subsection, the Comptroller General of the United States shall, to the extent data are available—</text><subparagraph id="HE833E5FD175E411DBD47C24BC9E5CD69"><enum>(A)</enum><text>conduct a review concerning the activities under this subsection; and</text></subparagraph><subparagraph id="H306202AE359C4FC5A22F0F5976FF644A"><enum>(B)</enum><text>submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Finance of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on such review, including related recommendations, as applicable.</text></subparagraph></paragraph><paragraph id="H11A460EEEAA24A87A1F9AC304B57A0BA"><enum>(6)</enum><header>Sunset</header><text display-inline="yes-display-inline">The authority to collect registration fees under paragraph (1) shall expire on the date that is 3 years after the date of enactment of the Health Improvements, Extenders, and Reauthorizations Act.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="H2E4ED32FB08F42C78279676D1752999D"><enum>713.</enum><header>Honor Our Living Donors</header><subsection id="HF15964DC80AC4AF28CAE42062F709203" display-inline="no-display-inline"><enum>(a)</enum><header>No consideration of income of organ recipient</header><text>Section 377 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/274f">42 U.S.C. 274f</external-xref>) is amended—</text><paragraph id="HC86ADC51C6DF421CAF19DD985F10AA91"><enum>(1)</enum><text>by redesignating subsections (c) through (f) as subsections (d) through (g), respectively;</text></paragraph><paragraph id="H0FA573FEF193450A9CA02A27422DC0D6"><enum>(2)</enum><text>by inserting after subsection (b) the following:</text><quoted-block id="H8DA7D41389A84B928B363ACEC196BC5B" style="OLC"><subsection id="H7E34DB08F8B4488089D0BCC3D7EEA74C"><enum>(c)</enum><header>No consideration of income of organ recipient</header><text>The recipient of a grant under this section, in providing reimbursement to a donating individual through such grant, shall not give any consideration to the income of the organ recipient.</text></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="HAAEA02EA6C88404291AFB589A1E8EAD1"><enum>(3)</enum><text>in subsection (f), as so redesignated—</text><subparagraph id="HBC1CE32DC8914910BFFB0D21B64DBEC3"><enum>(A)</enum><text>in paragraph (1), by striking <quote>subsection (c)(1)</quote> and inserting <quote>subsection (d)(1)</quote>; and</text></subparagraph><subparagraph id="HE60850A7082543B5AB409691DF3C7051"><enum>(B)</enum><text>in paragraph (2), by striking <quote>subsection (c)(2)</quote> and inserting <quote>subsection (d)(2)</quote>.</text></subparagraph></paragraph></subsection><subsection id="HD5BD13ED3F1043B2A6C07B2370C7D2EB" display-inline="no-display-inline"><enum>(b)</enum><header>Removal of expectation of payments by organ recipients</header><text>Section 377(e) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/274f">42 U.S.C. 274f(e)</external-xref>), as redesignated by section 2(1), is amended—</text><paragraph id="H34D13318EC4B4F6CAD3A3F5B281FF9F6"><enum>(1)</enum><text>in paragraph (1), by adding <quote>or</quote> at the end;</text></paragraph><paragraph id="HCD1F436EB4E14B5B9CD7130A77C62440"><enum>(2)</enum><text>in paragraph (2), by striking <quote>; or</quote> and inserting a period; and</text></paragraph><paragraph id="H788BD599E6E64B1FB4D501EA12B97501"><enum>(3)</enum><text>by striking paragraph (3).</text></paragraph></subsection><subsection id="H60FC3744516044CA80319CD5FB19F718" display-inline="no-display-inline"><enum>(c)</enum><header>Annual report</header><text>Section 377 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/274f">42 U.S.C. 274f</external-xref>), as amended by sections 2 and 3, is amended by adding at the end the following:</text><quoted-block id="H5CE9398669084353AF1CAC382B1EB61D" style="OLC"><subsection id="H703FB9C4185B4F2CB7517BA2C4C91436"><enum>(h)</enum><header>Annual report</header><text>Not later than December 31 of each year, beginning in Fiscal Year 2026, the Secretary shall—</text><paragraph id="H0FA42D8775794E40AF0AFED103FAF364"><enum>(1)</enum><text>prepare, submit to the Congress, and make public a report on whether grants under this section provided adequate funding during the preceding fiscal year to reimburse all donating individuals participating in the grant program under this section for all qualifying expenses; and</text></paragraph><paragraph id="HB37D821BB47A403FA48F218B6B156327"><enum>(2)</enum><text>include in each such report—</text><subparagraph id="HCCFC8B70712F4D478C2E071B2AA2B1C5"><enum>(A)</enum><text>the estimated number of all donating individuals participating in the grant program under this section who did not receive reimbursement for all qualifying expenses during the preceding fiscal year; and</text></subparagraph><subparagraph id="H5EFA178036134B72AB8AF9D065AB9899"><enum>(B)</enum><text>the total amount of funding that is estimated to be necessary to fully reimburse all donating individuals participating in the grant program under this section for all qualifying expenses.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section id="HAC3C8467B1F94155AA4FB2A38EA0D2FE"><enum>714.</enum><header>Program for pediatric studies of drugs</header><text display-inline="no-display-inline">Section 409I(d)(1) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/284m">42 U.S.C. 284m(d)(1)</external-xref>) is amended by striking <quote>section,</quote> and all that follows through the period at the end and inserting <quote>section, $25,000,000 for each of fiscal years 2025 through 2027.</quote>.</text></section></title><title id="HD207A985FEE649FDB9441D5DEE17053F"><enum>VIII</enum><header>Food and Drug Administration</header><subtitle id="HD5D53AF4D3054A0D825BA0A3F6894449"><enum>A</enum><header>Give Kids a Chance </header><section id="H9FF0ECF4725640E487457031E9527984"><enum>801.</enum><header>Research into pediatric uses of drugs; additional authorities of Food and Drug Administration regarding molecularly targeted cancer drugs</header><subsection id="H55D75D7BFA0A4337B6DD9E7C686F0CDA"><enum>(a)</enum><header>In general</header><paragraph id="HC2D06A1E83DF4F4D9C14C8B8DC7FBD28"><enum>(1)</enum><header>Additional active ingredient for application drug; limitation regarding novel-combination application drug</header><text>Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(a)(3)</external-xref>) is amended—</text><subparagraph id="HDBAF9208E8A74F6C86403933C68B387D"><enum>(A)</enum><text>by redesignating subparagraphs (B) and (C) as subparagraphs (C) and (D), respectively; and</text></subparagraph><subparagraph id="H98FC2D2113F649758D4A2C4D0AC0154E"><enum>(B)</enum><text>by striking subparagraph (A) and inserting the following:</text><quoted-block style="OLC" id="H218B71CF470046FA99B06E07B84C66F3"><subparagraph id="HAA107C2B7ED943E5A3D0E7B518ECE688"><enum>(A)</enum><header>In general</header><text>For purposes of paragraph (1)(B), the investigation described in this paragraph is a molecularly targeted pediatric cancer investigation of—</text><clause id="H6D572D906EA044AEBBDE1E0B117CA6A0"><enum>(i)</enum><text>the drug or biological product for which the application referred to in such paragraph is submitted; or</text></clause><clause id="H44855E0548F54EACAD7C0F26B993531F"><enum>(ii)</enum><text>such drug or biological product used in combination with—</text><subclause id="H57BB45E59FA249F88A20E24C97F21E96"><enum>(I)</enum><text display-inline="yes-display-inline">an active ingredient of a drug or biological product—</text><item id="H3616C5E2AEED45859BE5D73C637911D2"><enum>(aa)</enum><text>for which an approved application under section 505(j) under this Act or under section 351(k) of the Public Health Service Act is in effect; and</text></item><item id="H9DF4D39287924B8B88AB10F624AF2D36"><enum>(bb)</enum><text display-inline="yes-display-inline">that is determined by the Secretary, after consultation with the applicant, to be part of the standard of care for treating a pediatric cancer; or</text></item></subclause><subclause id="H2701B9FC75E943AE8FB1CA3DB2570C95"><enum>(II)</enum><text display-inline="yes-display-inline">an active ingredient of a drug or biological product—</text><item id="HD5F870B1BC6E4A9BBF86082CD83CEBB9"><enum>(aa)</enum><text>for which an approved application under section 505(b) of this Act or section 351(a) of the Public Health Service Act to treat an adult cancer is in effect and is held by the same person submitting the application under paragraph (1)(B); and</text></item><item id="HC41B94677D8340ED8E4C763EFA93A4F2"><enum>(bb)</enum><text>that is directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer. </text></item></subclause></clause></subparagraph><subparagraph id="HAC2354DCE90B44B6BC6580723709FE80"><enum>(B)</enum><header>Additional requirements</header><clause id="H117E8DE4432344DE9BEA8C88453BD8E8"><enum>(i)</enum><header>Design of investigation</header><text display-inline="yes-display-inline">A molecularly targeted pediatric cancer investigation referred to in subparagraph (A) shall be designed to yield clinically meaningful pediatric study data that is gathered using appropriate formulations for each age group for which the study is required, regarding dosing, safety, and preliminary efficacy to inform potential pediatric labeling.</text></clause><clause id="H5D76CB583E3F42CCB311204E3B12D77F"><enum>(ii)</enum><header>Limitation</header><text>An investigation described in subparagraph (A)(ii) may be required only if the drug or biological product for which the application referred to in paragraph (1)(B) contains either—</text><subclause id="H793A3A87F3D14253A5E5B51EC3A59734"><enum>(I)</enum><text>a single new active ingredient; or </text></subclause><subclause id="H1D919FEE272E4551A545001453D25A28"><enum>(II)</enum><text>more than one active ingredient, if an application for the combination of active ingredients has not previously been approved but each active ingredient is in a drug product that has been previously approved to treat an adult cancer. </text></subclause></clause><clause id="H701CCFC8BD9E493DBB8093561D5CF4B4"><enum>(iii)</enum><header>Results of already-completed preclinical studies of application drug</header><text>With respect to an investigation required pursuant to paragraph (1)(B), the Secretary may require the results of any completed preclinical studies relevant to the initial pediatric study plan be submitted to the Secretary at the same time that the initial pediatric study plan required under subsection (e)(1) is submitted. </text></clause><clause id="H347D624ED6BC44F59CDB99BF272B44E9"><enum>(iv)</enum><header>Rule of construction regarding inactive ingredients</header><text>With respect to a combination of active ingredients referred to in subparagraph (A)(ii), such subparagraph shall not be construed as addressing the use of inactive ingredients with such combination.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H698A21A93A7D40C080AF8ED6A02C7335"><enum>(2)</enum><header>Determination of applicable requirements</header><text display-inline="yes-display-inline">Section 505B(e)(1) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(e)(1)</external-xref>) is amended by adding at the end the following: <quote>The Secretary shall determine whether subparagraph (A) or (B) of subsection (a)(1) applies with respect to an application before the date on which the applicant is required to submit the initial pediatric study plan under paragraph (2)(A).</quote>.</text></paragraph><paragraph id="HAF4AA70F995047ADB3900B354BC6ABA6"><enum>(3)</enum><header>Clarifying applicability</header><text display-inline="yes-display-inline"><italic></italic>Section 505B(a)(1) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(a)(1)</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" id="H630DB6037D2A4860A82E0F96592FE621" display-inline="no-display-inline"><subparagraph id="H37C2FE1340BD48C898E0DCFC35371A65"><enum>(C)</enum><header>Rule of construction</header><text display-inline="yes-display-inline">No application that is subject to the requirements of subparagraph (B) shall be subject to the requirements of subparagraph (A), and no application (or supplement to an application) that is subject to the requirements of subparagraph (A) shall be subject to the requirements of subparagraph (B).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="HDA55B36EAFB34A2E8A38F0EC45B8E19F"><enum>(4)</enum><header>Conforming amendments</header><text>Section 505B(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(a)</external-xref>) is amended—</text><subparagraph id="H3B5A5DE8621C46A78BF2E5CF6C2FD28E"><enum>(A)</enum><text>in paragraph (3)(C), as redesignated by paragraph (1)(A) of this subsection, by striking <quote>investigations described in this paragraph</quote> and inserting <quote>investigations referred to in subparagraph (A)</quote>; and</text></subparagraph><subparagraph id="H545F7978593B4EE5A4BC8C57C4F35CC2"><enum>(B)</enum><text>in paragraph (3)(D), as redesignated by paragraph (1)(A) of this subsection, by striking <quote>the assessments under paragraph (2)(B)</quote> and inserting <quote>the assessments required under paragraph (1)(A)</quote>.</text></subparagraph></paragraph></subsection><subsection id="HCF1403166AE642DE82C7FFF96BC45DD7"><enum>(b)</enum><header>Guidance</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall—</text><paragraph id="H36B078C76C7E4D7892F45ABD2CCB6BFB"><enum>(1)</enum><text>not later than 12 months after the date of enactment of this Act, issue draft guidance on the implementation of the amendments made by subsection (a); and</text></paragraph><paragraph id="H844D8113BBF34659ACE25516952C8923"><enum>(2)</enum><text>not later than 12 months after closing the comment period on such draft guidance, finalize such guidance.</text></paragraph></subsection><subsection id="HF8489C131CF8484980A873780A5FE377" commented="no"><enum>(c)</enum><header>Applicability</header><text display-inline="yes-display-inline">The amendments made by this section apply with respect to any application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(b)</external-xref>) and any application under section 351(a) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(a)</external-xref>), that is submitted on or after the date that is 3 years after the date of enactment of this Act.</text></subsection><subsection id="HF0672675A0A348BD9300C0A9CECCE6FC"><enum>(d)</enum><header>Reports to Congress</header><paragraph id="HFB60B8D1A94C4C3D9F1F033125D9AC48"><enum>(1)</enum><header>Secretary of Health and Human Services</header><text display-inline="yes-display-inline">Not later than 6 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the Secretary’s efforts, in coordination with industry, to ensure implementation of the amendments made by subsection (a).</text></paragraph><paragraph id="HB1BD7666F00E442E94850105578135F4"><enum>(2)</enum><header>GAO study and report</header><subparagraph id="HAE3156B5EEAE4C459ADC675DE14B98AE"><enum>(A)</enum><header>Study</header><text>Not later than 8 years after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study of the effectiveness of requiring assessments and investigations described in section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.355c), as amended by subsection (a), in the development of drugs and biological products for pediatric cancer indications, including consideration of any benefits to, or burdens on, pediatric cancer drug development. </text></subparagraph><subparagraph id="HF536120CAC8540D68A1E0BC7F5D3F71E"><enum>(B)</enum><header>Findings</header><text>Not later than 10 years after the date of enactment of this Act, the Comptroller General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report containing the findings of the study conducted under subparagraph (A).</text></subparagraph></paragraph></subsection></section><section id="HFAC7CD4051A9455BA17DBBB350DCE8F3"><enum>802.</enum><header>Ensuring completion of pediatric study requirements</header><subsection id="H932D1F7CC20F42EBAFE711F76186A745"><enum>(a)</enum><header>Equal accountability for pediatric study requirements</header><text>Section 505B(d) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(d)</external-xref>) is amended—</text><paragraph id="HAA12759B721E40B491D59B2195C32A25"><enum>(1)</enum><text>in paragraph (1), by striking <quote>Beginning 270</quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Noncompliance letter.—</header-in-text>Beginning 270</quote>; </text></paragraph><paragraph id="H9545DB54247B4C858218F22EF59CEBF9"><enum>(2)</enum><text>in paragraph (2)—</text><subparagraph id="H468352C3FA574FCDA92DBCE3E2D5A5FA"><enum>(A)</enum><text>by striking <quote>The drug or</quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Effect of noncompliance.—</header-in-text>The drug or</quote>; and </text></subparagraph><subparagraph id="H0A76BDBEDC834507A6A8F9F635F7E73B"><enum>(B)</enum><text>by striking <quote>(except that the drug or biological product shall not be subject to action under section 303)</quote> and inserting <quote>(except that the drug or biological product shall be subject to action under section 303 only if such person demonstrated a lack of due diligence in satisfying the applicable requirement)</quote>; and</text></subparagraph></paragraph><paragraph id="H60F56A722EEB41A5B3D62346C05E2319"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" id="H5FB04E5ADB084CCB9033FFE3A11FDCE8" display-inline="no-display-inline"><paragraph id="H3AC47EEB51C042BBA9C37A44FDA93496"><enum>(3)</enum><header>Limitation</header><text>The Secretary shall not issue enforcement actions under section 303 for failures under this subsection in the case of a drug or biological product that is no longer marketed.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H62E4C40A6FC740DD8D81E54B9B159539"><enum>(b)</enum><header>Due diligence</header><text>Section 505B(d) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(d)</external-xref>), as amended by subsection (a), is further amended by adding at the end the following:</text><quoted-block id="HC56175D81BF04EA7A1F2133A87ED3355" style="OLC"><paragraph id="HE3EF1588F90C4FECA0F7A28BBBEEB25D"><enum>(4)</enum><header>Due diligence</header><text>Before the Secretary may conclude that a person failed to submit or otherwise meet a requirement as described in the matter preceding paragraph (1), the Secretary shall—</text><subparagraph id="H433136CDC6484AC8B8A6F07451C7A812"><enum>(A)</enum><text>issue a noncompliance letter pursuant to paragraph (1);</text></subparagraph><subparagraph id="H98144C34826D4ADA98A8097354106D1C"><enum>(B)</enum><text>provide such person with a 45-day period beginning on the date of receipt of such noncompliance letter to respond in writing as set forth in such paragraph; and</text></subparagraph><subparagraph id="H224485212D0A46CD9785294BBE538005"><enum>(C)</enum><text>after reviewing such written response, determine whether the person demonstrated a lack of due diligence in satisfying such requirement.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H1DC0349754274F2AB8B289F990360572"><enum>(c)</enum><header>Conforming amendments</header><text>Section 303(f)(4)(A) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333(f)(4)(A)</external-xref>) is amended by striking <quote>or 505–1</quote> and inserting <quote>505–1, or 505B</quote>.</text></subsection><subsection id="H6F877E0526B44D65B2E2CDA5C2C9A6DA"><enum>(d)</enum><header>Transition rule</header><text>The Secretary of Health and Human Services may take enforcement action under section 303 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333</external-xref>) only for failures described in section 505B(d) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(d)</external-xref>) that occur on or after the date that is 180 days after the date of enactment of this Act.</text></subsection></section><section id="HC937B1B9992A4500985EB08689C628BC"><enum>803.</enum><header>FDA report on PREA enforcement</header><text display-inline="no-display-inline">Section 508(b) of the Food and Drug Administration Safety and Innovation Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c-1">21 U.S.C. 355c–1(b)</external-xref>) is amended—</text><paragraph id="H1CD5B6876A1B4DB5959B9A440666BC33"><enum>(1)</enum><text>in paragraph (11), by striking the semicolon at the end and inserting <quote>, including an evaluation of compliance with deadlines provided for in deferrals and deferral extensions;</quote>;</text></paragraph><paragraph id="H9F5F51D4CFEE4533909E72087FB955A6"><enum>(2)</enum><text>in paragraph (15), by striking <quote>and</quote> at the end;</text></paragraph><paragraph id="HB89555253B6E45E4B735099253F87517"><enum>(3)</enum><text>in paragraph (16), by striking the period at the end and inserting <quote>; and</quote>; and</text></paragraph><paragraph id="H64AF615AB4224F53A360C0BF63509AE9"><enum>(4)</enum><text>by adding at the end the following:</text><quoted-block id="H016A944FDA544E9BA76A56AB316E3D97" style="OLC"><paragraph id="H4AF98F34D1B04E9880C775F94FB9868D"><enum>(17)</enum><text>a listing of penalties, settlements, or payments under section 303 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/353">21 U.S.C. 353</external-xref>) for failure to comply with requirements under such section 505B, including, for each penalty, settlement, or payment, the name of the drug, the sponsor thereof, and the amount of the penalty, settlement, or payment imposed; and</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="HF84A92B32F864E98AFE039AA97606418" commented="no"><enum>804.</enum><header>Extension of authority to issue priority review vouchers to encourage treatments for rare pediatric diseases</header><subsection id="H67AEC367BD9841B69689815E16DD6AC9" commented="no"><enum>(a)</enum><header>Extension</header><text display-inline="yes-display-inline">Paragraph (5) of section 529(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ff">21 U.S.C. 360ff(b)</external-xref>) is amended by striking <quote>December 20, 2024, unless</quote> and all that follows through the period at the end and inserting <quote>September 30, 2029.</quote>.</text></subsection><subsection id="H1E553FA38E62458A984E76BF138C2027" commented="no"><enum>(b)</enum><header>User fee payment</header><text>Section 529(c)(4) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ff">21 U.S.C. 360ff(c)(4)</external-xref>) is amended by striking subparagraph (A) and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H4116C038452540C193317A5A6B5B93FE"><subparagraph id="H848953B0615C490B8B1E6CF14494618D" commented="no"><enum>(A)</enum><header>In general</header><text>The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 505(b)(1) or section 351(a) of the Public Health Service Act for which the priority review voucher is used. All other user fees associated with the human drug application shall be due as required by the Secretary or under applicable law.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H86D149A61F5347758689007884440203" commented="no"><enum>(c)</enum><header>GAO report on effectiveness of rare pediatric disease priority voucher awards in incentivizing rare pediatric disease drug development</header><paragraph id="HB666E332D1774D47A1899DF80488F498" commented="no"><enum>(1)</enum><header>GAO study</header><subparagraph id="HC7B1A5EFA3674CD787F57F9368E0C96A" commented="no"><enum>(A)</enum><header>Study</header><text display-inline="yes-display-inline">The Comptroller General of the United States shall conduct a study of the effectiveness of awarding rare pediatric disease priority vouchers under section 529 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ff">21 U.S.C. 360ff</external-xref>), as amended by subsection (a), in the development of human drug products that treat or prevent rare pediatric diseases (as defined in such section 529).</text></subparagraph><subparagraph id="HFA0329ED2E5B4E5389132C73CF496C36" commented="no"><enum>(B)</enum><header>Contents of study</header><text display-inline="yes-display-inline">In conducting the study under subparagraph (A), the Comptroller General shall examine the following: </text><clause id="H44955671BD904B46AEC084C67B2B8685" commented="no"><enum>(i)</enum><text display-inline="yes-display-inline">The indications for each drug or biological product that—</text><subclause id="HCC564A8416884449B3ECF14D5BA58B88" commented="no"><enum>(I)</enum><text>is the subject of a rare pediatric disease product application (as defined in section 529 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ff">21 U.S.C. 360ff</external-xref>)) for which a priority review voucher was awarded; and</text></subclause><subclause id="H257CFC0124D9463D9FD865CF9B3085E6" commented="no"><enum>(II)</enum><text>was approved under section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/42/355">42 U.S.C. 355</external-xref>) or licensed under section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>).</text></subclause></clause><clause id="H684F4DB4BFC34DA68C2038B6EC4B70F5" commented="no"><enum>(ii)</enum><text>Whether, and to what extent, an unmet need related to the treatment or prevention of a rare pediatric disease was met through the approval or licensure of such a drug or biological product. </text></clause><clause id="HBF71EEC04B264744BFB161F30A8FFAC1" commented="no"><enum>(iii)</enum><text display-inline="yes-display-inline">The size of the company to which a priority review voucher was awarded under section 529 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ff">21 U.S.C. 360ff</external-xref>) for such a drug or biological product.</text></clause><clause id="H39D54AEFF74F4969B9783F9CA25E9F9A" commented="no"><enum>(iv)</enum><text>The value of such priority review voucher if transferred. </text></clause><clause id="H5B174E88BA1B48D3B44766632383BE2B" commented="no"><enum>(v)</enum><text>Identification of each drug for which a priority review voucher awarded under such section 529 was used. </text></clause><clause id="H796FC71BA3A5412EB294BF3B40218C54" commented="no"><enum>(vi)</enum><text>The size of the company using each priority review voucher awarded under such section 529.</text></clause><clause id="HF6A05779FD504BFCA98A034E4DF034FC" commented="no"><enum>(vii)</enum><text display-inline="yes-display-inline">The length of the period of time between the date on which a priority review voucher was awarded under such section 529 and the date on which it was used. </text></clause><clause id="HF11059BCCD7E4D63BBB82D453A5EED36" commented="no"><enum>(viii)</enum><text display-inline="yes-display-inline">Whether, and to what extent, an unmet need related to the treatment or prevention of a rare pediatric disease was met through the approval under section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/42/355">42 U.S.C. 355</external-xref>) or licensure under section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>) of a drug for which a priority review voucher was used.</text></clause><clause id="H57BECBD46B9D4BD2B2DDFAE413EBB561" commented="no"><enum>(ix)</enum><text display-inline="yes-display-inline">Whether, and to what extent, companies were motivated by the availability of priority review vouchers under section 529 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ff">21 U.S.C. 360ff</external-xref>) to attempt to develop a drug for a rare pediatric disease.</text></clause><clause id="H0383BF50F71A427192F8E04B0C3CBFED" commented="no"><enum>(x)</enum><text>Whether, and to what extent, pediatric review vouchers awarded under such section were successful in stimulating development and expedited patient access to drug products for treatment or prevention of a rare pediatric disease that wouldn’t otherwise take place without the incentive provided by such vouchers.</text></clause><clause id="H4EFE950105BB4826BA855A0AB3EADE43" commented="no"><enum>(xi)</enum><text>The impact of such priority review vouchers on the workload, review process, and public health prioritization efforts of the Food and Drug Administration.</text></clause><clause id="HF129FE1B4C1A4D3C8486BF9FF348E7A4" commented="no"><enum>(xii)</enum><text>Any other incentives in Federal law that exist for companies developing drugs or biological products described in clause (i).</text></clause></subparagraph></paragraph><paragraph id="H27FEFC541E584DB29029D0753A6C8EAD" commented="no"><enum>(2)</enum><header>Report on findings</header><text display-inline="yes-display-inline">Not later than 5 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report containing the findings of the study conducted under paragraph (1).</text></paragraph></subsection></section><section id="H22DB8B0B03D74F96AB7688B63ED536C7"><enum>805.</enum><header>Limitations on exclusive approval or licensure of orphan drugs</header><subsection id="H31368FD4CD2C43E48EFA2B244BF1B470"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 527 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360cc">21 U.S.C. 360cc</external-xref>) is amended—</text><paragraph id="HBCCEB33B44AC4185BB3801FAE6705AEE"><enum>(1)</enum><text>in subsection (a), in the matter following paragraph (2), by striking <quote>same disease or condition</quote> and inserting <quote>same approved use or indication within such rare disease or condition</quote>;</text></paragraph><paragraph id="HF8DF60023E2448489CC6495A848680C6"><enum>(2)</enum><text>in subsection (b)—</text><subparagraph id="H65676E23B7FE4D708855106F7781EABD"><enum>(A)</enum><text>in the matter preceding paragraph (1), by striking <quote>same rare disease or condition</quote> and inserting <quote>same approved use or indication for which such 7-year period applies to such already approved or licensed drug</quote>; and</text></subparagraph><subparagraph id="HB8DB55D93D5C4C1381820211C9588E99"><enum>(B)</enum><text>in paragraph (1), by inserting <quote>, relating to the approved use or indication,</quote> after <quote>the needs</quote>;</text></subparagraph></paragraph><paragraph id="H4D3AE57654AF43979155BCA1043814CC"><enum>(3)</enum><text>in subsection (c)(1), by striking <quote>same rare disease or condition as the already approved drug</quote> and inserting <quote>same use or indication for which the already approved or licensed drug was approved or licensed</quote>; and</text></paragraph><paragraph id="H9AC2CC8322A545BF82CA8AD3E954C6D7"><enum>(4)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HB94C13ED196A4F4DA69AA84E67F14B1B"><subsection id="H03B10DC443994199BFA05798555386EF"><enum>(f)</enum><header>Approved use or indication defined</header><text>In this section, the term <term>approved use or indication</term> means the use or indication approved under section 505 of this Act or licensed under section 351 of the Public Health Service Act for a drug designated under section 526 for a rare disease or condition.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HF0543B0377C24D3181F6BF8A5A67C29D"><enum>(b)</enum><header>Application of amendments</header><text>The amendments made by subsection (a) shall apply with respect to any drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360bb">21 U.S.C. 360bb</external-xref>), regardless of the date on which the drug was so designated, and regardless of the date on which the drug was approved under section 505 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) or licensed under section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>).</text></subsection></section></subtitle><subtitle id="HD00FC2685EE744F5AD90485FDD3EA5D0"><enum>B</enum><header>United States-Abraham Accords Cooperation and Security</header><section id="H1B22A1977A4240538AEB2DC065AD45EA"><enum>811.</enum><header>Establishment of Abraham Accords Office within Food and Drug Administration</header><subsection id="H48F9A1A54FBB41A992759D4276AE8F34"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Chapter X of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/391">21 U.S.C. 391 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" id="H541F2BBE16A74527B296AABFCF6C2BAE" display-inline="no-display-inline"><section id="HEE1F4D1D358D4D108562B047FE0929E9"><enum>1015.</enum><header>Abraham Accords Office</header><subsection id="HE7B69FD65BB74E8E926C7A311B897B6D"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary, acting through the Commissioner of Food and Drugs, shall establish within the Food and Drug Administration an office, to be known as the Abraham Accords Office, to be headed by a director.</text></subsection><subsection id="HE317CA0B760E4A1F9F1B3CE33CEB3E36"><enum>(b)</enum><header>Office</header><text display-inline="yes-display-inline">Not later than 2 years after the date of enactment of this section, the Secretary shall—</text><paragraph id="H4CFA709490214939AD6893FACFC843C1"><enum>(1)</enum><text display-inline="yes-display-inline">in consultation with the governments of Abraham Accords countries, as well as appropriate United States Government diplomatic and security personnel—</text><subparagraph id="HFD1B394012CA40AFAC65EB93986D847F"><enum>(A)</enum><text>select the location of the Abraham Accords Office in an Abraham Accords country; and</text></subparagraph><subparagraph id="HA8E44910E28442748DF30704626DB192"><enum>(B)</enum><text>establish such office; and</text></subparagraph></paragraph><paragraph id="H1199088F25964253920A56CAA7B8D66A"><enum>(2)</enum><text>assign to such office such personnel of the Food and Drug Administration as the Secretary determines necessary to carry out the functions of such office.</text></paragraph></subsection><subsection id="H4094B98C37CC4B4689EA3B01FEBD1720"><enum>(c)</enum><header>Duties</header><text display-inline="yes-display-inline">The Secretary, acting through the Director of the Abraham Accords Office, shall—</text><paragraph id="H7935B98E3935473889C2EE43919FE8CD"><enum>(1)</enum><text display-inline="yes-display-inline">after the Abraham Accords Office is established—</text><subparagraph id="H6B573644310B454A9DD37F4700513388"><enum>(A)</enum><text display-inline="yes-display-inline">as part of the Food and Drug Administration’s work to strengthen the international oversight of regulated commodities, provide technical assistance to regulatory partners in Abraham Accords countries on strengthening regulatory oversight and converging regulatory requirements for the oversight of regulated products, including good manufacturing practices and other issues relevant to manufacturing medical products that are regulated by the Food and Drug Administration; and</text></subparagraph><subparagraph id="H51169A83BDDA4AF59BC945B5084555C0"><enum>(B)</enum><text display-inline="yes-display-inline">facilitate interactions between the Food and Drug Administration and interested parties in Abraham Accords countries, including by sharing relevant information regarding United States regulatory pathways with such parties, and facilitate feedback on the research, development, and manufacturing of products regulated in accordance with this Act; and </text></subparagraph></paragraph><paragraph id="HA2716876F0AF4F0FA00BC8B154ADE12F"><enum>(2)</enum><text display-inline="yes-display-inline">carry out other functions and activities as the Secretary determines to be necessary to carry out this section.</text></paragraph></subsection><subsection id="H473D89B0E4EC4E86B3FC6A3F90800812"><enum>(d)</enum><header>Abraham Accords country defined</header><text>In this section, the term <term>Abraham Accords country</term> means a country identified by the Department of State as having signed the Abraham Accords Declaration.</text></subsection><subsection id="H7577BD1313A4412F975AE60BA24E9240"><enum>(e)</enum><header>National security</header><text>Nothing in this section shall be construed to require any action inconsistent with a national security recommendation provided by the Federal Government.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H4F87747AF2394A5E831BAFCAF9BE8693"><enum>(b)</enum><header>Report to Congress</header><paragraph id="HA1D2F1482C1B41FABA789E4F2A114D14"><enum>(1)</enum><header>In general</header><text>Not later than 3 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Congress a report on the Abraham Accords Office, including—</text><subparagraph id="H5699F1FB19CC4FCBA480D087E3D8F5CA"><enum>(A)</enum><text display-inline="yes-display-inline">an evaluation of how the Office has advanced progress toward conformance with Food and Drug Administration regulatory requirements by manufacturers in the Abraham Accords countries;</text></subparagraph><subparagraph id="H4B38B230697E4409A125D0BFFBDB1429"><enum>(B)</enum><text display-inline="yes-display-inline">a numerical count of parties that the Office has helped facilitate interactions or feedback pursuant to section 1015(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a));</text></subparagraph><subparagraph id="H1A67A2586C7F47139E9DB66802729177"><enum>(C)</enum><text display-inline="yes-display-inline">a summary of technical assistance provided to regulatory partners in Abraham Accords countries pursuant to subparagraph (A) of such section 1015(c)(1); and </text></subparagraph><subparagraph id="HD78D799D30544F16B454E79127F1E062"><enum>(D)</enum><text display-inline="yes-display-inline">recommendations for increasing and improving coordination between the Food and Drug Administration and entities in Abraham Accords countries.</text></subparagraph></paragraph><paragraph id="H8F5EEEC51EC14422A86C04B798F43076"><enum>(2)</enum><header>Abraham Accords country defined</header><text>In this subsection, the term <term>Abraham Accords country</term> has the meaning given such term in section 1015(d) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).</text></paragraph></subsection></section></subtitle></title><title id="HD287EE8C303F40EE96D11AF4DE0AC86D"><enum>IX</enum><header>Lowering prescription drug costs</header><section id="H89EE0D52148F466A964B7E49C3B1FE6B"><enum>901.</enum><header>Oversight of pharmacy benefit management services</header><subsection id="HBF87328FA12642AF88F21BE2EA695E5E"><enum>(a)</enum><header>Public Health Service Act</header><text>Title XXVII of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg">42 U.S.C. 300gg et seq.</external-xref>) is amended—</text><paragraph id="H571562B182CC4AA8AFBA254F4F5AAEF4"><enum>(1)</enum><text>in part D (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-111">42 U.S.C. 300gg–111 et seq.</external-xref>), by adding at the end the following new section:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H4FC735A3D06E4215991D49267FCDC240"><section id="H46F09500223A42C78D6FDCED29038259"><enum>2799A–11.</enum><header>Oversight of entities that provide pharmacy benefit management services</header><subsection id="H9BD1864510754C5B965E05E69E53780A"><enum>(a)</enum><header>In general</header><text>For plan years beginning on or after the date that is 30 months after the date of enactment of this section (referred to in this subsection and subsection (b) as the <quote>effective date</quote>), a group health plan or a health insurance issuer offering group health insurance coverage, or an entity providing pharmacy benefit management services on behalf of such a plan or issuer, shall not enter into a contract, including an extension or renewal of a contract, entered into on or after the effective date, with an applicable entity unless such applicable entity agrees to—</text><paragraph id="H4B58CFA5FDAF4AF8851BE201D2B03C09"><enum>(1)</enum><text>not limit or delay the disclosure of information to the group health plan (including such a plan offered through a health insurance issuer) in such a manner that prevents an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage from making the reports described in subsection (b); and</text></paragraph><paragraph id="H7A0E6E6CD94C498788F225E7A992E318"><enum>(2)</enum><text>provide the entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer relevant information necessary to make the reports described in subsection (b).</text></paragraph></subsection><subsection id="H8B66A3329F834F50AB9B9616E22D1B18"><enum>(b)</enum><header>Reports</header><paragraph id="H99E4E16F12BA4A5A8FE7EFDB8F001D4B"><enum>(1)</enum><header>In general</header><text>For plan years beginning on or after the effective date, in the case of any contract between a group health plan or a health insurance issuer offering group health insurance coverage offered in connection with such a plan and an entity providing pharmacy benefit management services on behalf of such plan or issuer, including an extension or renewal of such a contract, entered into on or after the effective date, the entity providing pharmacy benefit management services on behalf of such a group health plan or health insurance issuer, not less frequently than every 6 months (or, at the request of a group health plan, not less frequently than quarterly, and under the same conditions, terms, and cost of the semiannual report under this subsection), shall submit to the group health plan a report in accordance with this section. Each such report shall be made available to such group health plan in plain language, in a machine-readable format, and as the Secretary may determine, other formats. Each such report shall include the information described in paragraph (2).</text></paragraph><paragraph id="H4F992DCEB9BB44E6B48EB05A28099449"><enum>(2)</enum><header>Information described</header><text>For purposes of paragraph (1), the information described in this paragraph is, with respect to drugs covered by a group health plan or group health insurance coverage offered by a health insurance issuer in connection with a group health plan during each reporting period—</text><subparagraph id="HEAEBF6CE328845F8986FCAD98E71C6AB"><enum>(A)</enum><text>in the case of a group health plan that is offered by a specified large employer or that is a specified large plan, and is not offered as health insurance coverage, or in the case of health insurance coverage for which the election under paragraph (3) is made for the applicable reporting period—</text><clause id="H056CF83F1C0E448095F65D047D8D9C45"><enum>(i)</enum><text>a list of drugs for which a claim was filed and, with respect to each such drug on such list—</text><subclause id="H69ACBD7312BC465AB003F42BF769EE30"><enum>(I)</enum><text>the contracted compensation paid by the group health plan or health insurance issuer for each covered drug (identified by the National Drug Code) to the entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan or health insurance issuer;</text></subclause><subclause id="H531471DD65064FE8930BDF1A4107E2E4"><enum>(II)</enum><text>the contracted compensation paid to the pharmacy, by any entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan or health insurance issuer, for each covered drug (identified by the National Drug Code);</text></subclause><subclause id="H70319EC186BC45D8B9FD509508AE9954"><enum>(III)</enum><text>for each such claim, the difference between the amount paid under subclause (I) and the amount paid under subclause (II);</text></subclause><subclause id="HC5E11B7EEF05484CA31F3D1767FBBEF5"><enum>(IV)</enum><text>the proprietary name, established name or proper name, and the National Drug Code;</text></subclause><subclause id="H2AAFB53ADA654A85837708401C922DBA"><enum>(V)</enum><text>for each claim for the drug (including original prescriptions and refills) and for each dosage unit of the drug for which a claim was filed, the type of dispensing channel used to furnish the drug, including retail, mail order, or specialty pharmacy;</text></subclause><subclause id="H908740FD674F46CC99CD8B658CF26363"><enum>(VI)</enum><text>with respect to each drug dispensed, for each type of dispensing channel (including retail, mail order, or specialty pharmacy)—</text><item commented="no" display-inline="no-display-inline" id="HC6770B443C884DBE942DEE30C60B2388"><enum>(aa)</enum><text display-inline="yes-display-inline">whether such drug is a brand name drug or a generic drug, and—</text><subitem id="H3555A3BED56643DDBFED3FFFDCAC3D91"><enum>(AA)</enum><text>in the case of a brand name drug, the wholesale acquisition cost, listed as cost per days supply and cost per dosage unit, on the date such drug was dispensed; and</text></subitem><subitem id="HD502326C633D42958785DE99F4C6DACC"><enum>(BB)</enum><text>in the case of a generic drug, the average wholesale price, listed as cost per days supply and cost per dosage unit, on the date such drug was dispensed; and</text></subitem></item><item id="H28E94A2DD57A447CB48AED19045061F6"><enum>(bb)</enum><text>the total number of—</text><subitem id="H23D0543948694FD9ABB2630DDD8D8B63"><enum>(AA)</enum><text>prescription claims (including original prescriptions and refills);</text></subitem><subitem id="H28D5DFC31BC14BEBBD4E48E64C6FC228"><enum>(BB)</enum><text>participants and beneficiaries for whom a claim for such drug was filed through the applicable dispensing channel;</text></subitem><subitem id="H2700FBCF7B25413E826C5549C458DB0A"><enum>(CC)</enum><text>dosage units and dosage units per fill of such drug; and</text></subitem><subitem id="H33C72A7C12C54D0DAC12F312B555FC74"><enum>(DD)</enum><text>days supply of such drug per fill;</text></subitem></item></subclause><subclause id="HB85074D5D32B4CF1A489ADA11973F2E4"><enum>(VII)</enum><text>the net price per course of treatment or single fill, such as a 30-day supply or 90-day supply to the plan or coverage after rebates, fees, alternative discounts, or other remuneration received from applicable entities;</text></subclause><subclause id="HBF28D4E751084649971F877A0CCFFE2B"><enum>(VIII)</enum><text>the total amount of out-of-pocket spending by participants and beneficiaries on such drug, including spending through copayments, coinsurance, and deductibles, but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage, or for which no claim is submitted under the plan or coverage;</text></subclause><subclause commented="no" id="HD279F8FF2AF94620B1338D7543CBFA37"><enum>(IX)</enum><text>the total net spending on the drug;</text></subclause><subclause id="H8F16B6CCCE24416CB3A3F042C9423FAB"><enum>(X)</enum><text>the total amount received, or expected to be received, by the plan or issuer from any applicable entity in rebates, fees, alternative discounts, or other remuneration;</text></subclause><subclause id="H3FAFF50103554FA78F15F930B41FFBC8"><enum>(XI)</enum><text>the total amount received, or expected to be received, by the entity providing pharmacy benefit management services, from applicable entities, in rebates, fees, alternative discounts, or other remuneration from such entities— </text><item commented="no" display-inline="no-display-inline" id="H41CE4A9880BD44A9A16A13AF060DB470"><enum>(aa)</enum><text display-inline="yes-display-inline">for claims incurred during the reporting period; and</text></item><item commented="no" display-inline="no-display-inline" id="HCC006A83652F4242830ACA78ACEE9F86"><enum>(bb)</enum><text display-inline="yes-display-inline">that is related to utilization of such drug or spending on such drug; and</text></item></subclause><subclause id="H66C8025113A148C9B85E9EBB33B7E76B"><enum>(XII)</enum><text>to the extent feasible, information on the total amount of remuneration for such drug, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copayment assistance on behalf of such drug manufacturer), to the participants and beneficiaries enrolled in such plan or coverage;</text></subclause></clause><clause id="HB257E64C0ADC42EA806D7CCC76212252"><enum>(ii)</enum><text>a list of each therapeutic class (as defined by the Secretary) for which a claim was filed under the group health plan or health insurance coverage during the reporting period, and, with respect to each such therapeutic class—</text><subclause id="HC8337B939C374034AF7573C677A77F86"><enum>(I)</enum><text>the total gross spending on drugs in such class before rebates, price concessions, alternative discounts, or other remuneration from applicable entities; </text></subclause><subclause id="H3981700734FE437D870D9EE0A636571C"><enum>(II)</enum><text>the net spending in such class after such rebates, price concessions, alternative discounts, or other remuneration from applicable entities; </text></subclause><subclause id="H9990418773EB4434AA7A869D2CD782D4"><enum>(III)</enum><text>the total amount received, or expected to be received, by the entity providing pharmacy benefit management services, from applicable entities, in rebates, fees, alternative discounts, or other remuneration from such entities— </text><item commented="no" display-inline="no-display-inline" id="H0F0043D2A71A4D19B1709C5467F5BE79"><enum>(aa)</enum><text display-inline="yes-display-inline">for claims incurred during the reporting period; and</text></item><item commented="no" display-inline="no-display-inline" id="H5C41CE2A58304DDA8C5FF7202826FA67"><enum>(bb)</enum><text display-inline="yes-display-inline">that is related to utilization of drugs or drug spending;</text></item></subclause><subclause id="H9DA46E012A9447F89AF57B18CD769D09"><enum>(IV)</enum><text>the average net spending per 30-day supply and per 90-day supply by the plan or by the issuer with respect to such coverage and its participants and beneficiaries, among all drugs within the therapeutic class for which a claim was filed during the reporting period;</text></subclause><subclause id="H2BB5568A0FA04B2BBF87F6A871DA627A"><enum>(V)</enum><text>the number of participants and beneficiaries who filled a prescription for a drug in such class, including the National Drug Code for each such drug;</text></subclause><subclause id="H98D5934CA24341DEA175930E051673A9"><enum>(VI)</enum><text>if applicable, a description of the formulary tiers and utilization mechanisms (such as prior authorization or step therapy) employed for drugs in that class; and</text></subclause><subclause id="H68A6B381B57C4F55890804051ECC320D"><enum>(VII)</enum><text>the total out-of-pocket spending under the plan or coverage by participants and beneficiaries, including spending through copayments, coinsurance, and deductibles, but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage or for which no claim is submitted under the plan or coverage;</text></subclause></clause><clause id="H353D0E88B559479E862B8B56E2399DAD"><enum>(iii)</enum><text>with respect to any drug for which gross spending under the group health plan or health insurance coverage exceeded $10,000 during the reporting period or, in the case that gross spending under the group health plan or coverage exceeded $10,000 during the reporting period with respect to fewer than 50 drugs, with respect to the 50 prescription drugs with the highest spending during the reporting period—</text><subclause commented="no" display-inline="no-display-inline" id="H39197E0C61BC4168A23F488F6B6689D2"><enum>(I)</enum><text display-inline="yes-display-inline">a list of all other drugs in the same therapeutic class as such drug; </text></subclause><subclause commented="no" display-inline="no-display-inline" id="H5DC054AC18BE400FABFACDA5CB204277"><enum>(II)</enum><text display-inline="yes-display-inline">if applicable, the rationale for the formulary placement of such drug in that therapeutic category or class, selected from a list of standard rationales established by the Secretary, in consultation with stakeholders; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H5C4EAE7E47D346A79A32DDCED563B67A"><enum>(III)</enum><text display-inline="yes-display-inline">any change in formulary placement compared to the prior plan year; and</text></subclause></clause><clause id="H36330FF318B447A4BD12D4A2D770255D"><enum>(iv)</enum><text>in the case that such plan or issuer (or an entity providing pharmacy benefit management services on behalf of such plan or issuer) has an affiliated pharmacy or pharmacy under common ownership, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost sharing assistance incentives funded by an entity providing pharmacy benefit services—</text><subclause id="H2FCC607929824886AB727EC2F15C3680"><enum>(I)</enum><text>an explanation of any benefit design parameters that encourage or require participants and beneficiaries in the plan or coverage to fill prescriptions at mail order, specialty, or retail pharmacies;</text></subclause><subclause id="H8EC5EABB31AA40E293880E267C877CA2"><enum>(II)</enum><text>the percentage of total prescriptions dispensed by such pharmacies to participants or beneficiaries in such plan or coverage; and</text></subclause><subclause id="H3163B380F6F248BBAC82070E23D4F979"><enum>(III)</enum><text>a list of all drugs dispensed by such pharmacies to participants or beneficiaries enrolled in such plan or coverage, and, with respect to each drug dispensed—</text><item id="HCC7D10CABDDC46FDB2A8015FA8E16A7B"><enum>(aa)</enum><text>the amount charged, per dosage unit, per 30-day supply, or per 90-day supply (as applicable) to the plan or issuer, and to participants and beneficiaries;</text></item><item id="H0DCA09A310A14CA3A28A0C98671CA511"><enum>(bb)</enum><text>the median amount charged to such plan or issuer, and the interquartile range of the costs, per dosage unit, per 30-day supply, and per 90-day supply, including amounts paid by the participants and beneficiaries, when the same drug is dispensed by other pharmacies that are not affiliated with or under common ownership with the entity and that are included in the pharmacy network of such plan or coverage;</text></item><item id="HD0654C142A764C49A9C1F2F2A96360BE"><enum>(cc)</enum><text>the lowest cost per dosage unit, per 30-day supply and per 90-day supply, for each such drug, including amounts charged to the plan or coverage and to participants and beneficiaries, that is available from any pharmacy included in the network of such plan or coverage; and</text></item><item id="H183D399E5153419BAFA3F7C46CFE0379"><enum>(dd)</enum><text>the net acquisition cost per dosage unit, per 30-day supply, and per 90-day supply, if such drug is subject to a maximum price discount; and</text></item></subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF8D8A85571544A6F8A4D25BA32E09E6D"><enum>(B)</enum><text>with respect to any group health plan, including group health insurance coverage offered in connection with such a plan, regardless of whether the plan or coverage is offered by a specified large employer or whether it is a specified large plan—</text><clause commented="no" display-inline="no-display-inline" id="H0B539B273DD341CDBC362E73E0484E27"><enum>(i)</enum><text display-inline="yes-display-inline">a summary document for the group health plan that includes such information described in clauses (i) through (iv) of subparagraph (A), as specified by the Secretary through guidance, program instruction, or otherwise (with no requirement of notice and comment rulemaking), that the Secretary determines useful to group health plans for purposes of selecting pharmacy benefit management services, such as an estimated net price to group health plan and participant or beneficiary, a cost per claim, the fee structure or reimbursement model, and estimated cost per participant or beneficiary; </text></clause><clause commented="no" display-inline="no-display-inline" id="H44B5A61CF7894787A91840F9C70108F6"><enum>(ii)</enum><text display-inline="yes-display-inline">a summary document for plans and issuers to provide to participants and beneficiaries, which shall be made available to participants or beneficiaries upon request to their group health plan (including in the case of group health insurance coverage offered in connection with such a plan), that—</text><subclause commented="no" display-inline="no-display-inline" id="H70DBE1A6C2E54D449B03FFC72B0D592F"><enum>(I)</enum><text display-inline="yes-display-inline">contains such information described in clauses (iii), (iv), (v), and (vi), as applicable, as specified by the Secretary through guidance, program instruction, or otherwise (with no requirement of notice and comment rulemaking) that the Secretary determines useful to participants or beneficiaries in better understanding the plan or coverage or benefits under such plan or coverage;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HF67C6064E78048579BDD2C032D7F7334"><enum>(II)</enum><text display-inline="yes-display-inline">contains only aggregate information; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H6DCE5DC937BA45D3B74770C3AC8070E9"><enum>(III)</enum><text display-inline="yes-display-inline">states that participants and beneficiaries may request specific, claims-level information required to be furnished under subsection (c) from the group health plan or health insurance issuer; and</text></subclause></clause><clause id="H28B94C201B934EB98C732D5E606E23CD"><enum>(iii)</enum><text>with respect to drugs covered by such plan or coverage during such reporting period—</text><subclause id="H851EF5083BFC4F1D9DAA5A843DDE12EB"><enum>(I)</enum><text>the total net spending by the plan or coverage for all such drugs;</text></subclause><subclause id="HB480FD912D4B45D8814572FCD11CE784"><enum>(II)</enum><text>the total amount received, or expected to be received, by the plan or issuer from any applicable entity in rebates, fees, alternative discounts, or other remuneration; and</text></subclause><subclause id="H40A54A73DA8A48DBAF48B84EEC97F71C"><enum>(III)</enum><text>to the extent feasible, information on the total amount of remuneration for such drugs, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copayment assistance on behalf of such drug manufacturer) to participants and beneficiaries;</text></subclause></clause><clause id="H4198CCF1D333457095FD29EAE55D07AE"><enum>(iv)</enum><text>amounts paid directly or indirectly in rebates, fees, or any other type of compensation (as defined in section 408(b)(2)(B)(ii)(dd)(AA) of the Employee Retirement Income Security Act) to brokerage firms, brokers, consultants, advisors, or any other individual or firm, for—</text><subclause id="H6BB6D0CC342145F08BAB575AC6915499"><enum>(I)</enum><text>the referral of the group health plan's or health insurance issuer's business to an entity providing pharmacy benefit management services, including the identity of the recipient of such amounts;</text></subclause><subclause id="H28D1151CABA44597836BC1F9E791F52A"><enum>(II)</enum><text>consideration of the entity providing pharmacy benefit management services by the group health plan or health insurance issuer; or</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H0D904926951A476F9C29AA3492F61C57"><enum>(III)</enum><text display-inline="yes-display-inline">the retention of the entity by the group health plan or health insurance issuer;</text></subclause></clause><clause id="H508AB3C975C24E83AD21F7CEC38DA736"><enum>(v)</enum><text>an explanation of any benefit design parameters that encourage or require participants and beneficiaries in such plan or coverage to fill prescriptions at mail order, specialty, or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services under such plan or coverage, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost-sharing assistance incentives directly or indirectly funded by such entity; and</text></clause><clause id="H0ABB210177FE437B9E53495CFCBF19F6"><enum>(vi)</enum><text>total gross spending on all drugs under the plan or coverage during the reporting period.</text></clause></subparagraph></paragraph><paragraph commented="no" id="HA2A434C7E07B42A88799325ABD86A361"><enum>(3)</enum><header>Opt-in for group health insurance coverage offered by a specified large employer or that is a specified large plan</header><text>In the case of group health insurance coverage offered in connection with a group health plan that is offered by a specified large employer or is a specified large plan, such group health plan may, on an annual basis, for plan years beginning on or after the date that is 30 months after the date of enactment of this section, elect to require an entity providing pharmacy benefit management services on behalf of the health insurance issuer to submit to such group health plan a report that includes all of the information described in paragraph (2)(A), in addition to the information described in paragraph (2)(B).</text></paragraph><paragraph id="H7ABA090B42364205B3C43719FBD7F26B"><enum>(4)</enum><header>Privacy requirements</header><subparagraph id="H524599F4D5A244978719EA10EF339A0E"><enum>(A)</enum><header>In general</header><text>An entity providing pharmacy benefit management services on behalf of a group health plan or a health insurance issuer offering group health insurance coverage shall report information under paragraph (1) in a manner consistent with the privacy regulations promulgated under section 13402(a) of the Health Information Technology for Economic and Clinical Health Act and consistent with the privacy regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 in part 160 and subparts A and E of part 164 of title 45, Code of Federal Regulations (or successor regulations) (referred to in this paragraph as the <quote>HIPAA privacy regulations</quote>) and shall restrict the use and disclosure of such information according to such privacy regulations and such HIPAA privacy regulations. </text></subparagraph><subparagraph id="H27A710CB9F14413F9FD4E08BB2706562"><enum>(B)</enum><header>Additional requirements</header><clause id="H928DBB9CC9DF409E8DFB40D81DE17838"><enum>(i)</enum><header>In general</header><text>An entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage that submits a report under paragraph (1) shall ensure that such report contains only summary health information, as defined in section 164.504(a) of title 45, Code of Federal Regulations (or successor regulations).</text></clause><clause id="HD8F2FCF66EE64765BE5FB45EAEA76F4F"><enum>(ii)</enum><header>Restrictions</header><text>In carrying out this subsection, a group health plan shall comply with section 164.504(f) of title 45, Code of Federal Regulations (or a successor regulation), and a plan sponsor shall act in accordance with the terms of the agreement described in such section. </text></clause></subparagraph><subparagraph id="H8AAF28A48F294C8683F8007CBDA0D66B"><enum>(C)</enum><header>Rule of construction</header><clause commented="no" display-inline="no-display-inline" id="H9D13ED59E2B5458AA7625EC1AF47ABAE"><enum>(i)</enum><text display-inline="yes-display-inline">Nothing in this section shall be construed to modify the requirements for the creation, receipt, maintenance, or transmission of protected health information under the HIPAA privacy regulations. </text></clause><clause commented="no" display-inline="no-display-inline" id="HB5A74ACA022C4BE79E68783113B9DB05"><enum>(ii)</enum><text display-inline="yes-display-inline">Nothing in this section shall be construed to affect the application of any Federal or State privacy or civil rights law, including the HIPAA privacy regulations, the Genetic Information Nondiscrimination Act of 2008 (<external-xref legal-doc="public-law" parsable-cite="pl/110/233">Public Law 110–233</external-xref>) (including the amendments made by such Act), the Americans with Disabilities Act of 1990 (<external-xref legal-doc="usc" parsable-cite="usc/42/12101">42 U.S.C. 12101 et seq.</external-xref>), section 504 of the Rehabilitation Act of 1973 (<external-xref legal-doc="usc" parsable-cite="usc/29/794">29 U.S.C. 794</external-xref>), section 1557 of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18116">42 U.S.C. 18116</external-xref>), title VI of the Civil Rights Act of 1964 (<external-xref legal-doc="usc" parsable-cite="usc/42/2000d">42 U.S.C. 2000d</external-xref>), and title VII of the Civil Rights Act of 1964 (<external-xref legal-doc="usc" parsable-cite="usc/42/2000e">42 U.S.C. 2000e</external-xref>). </text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H706EF53ED08D40C6A405ABBCE3A130D5"><enum>(D)</enum><header>Written notice</header><text display-inline="yes-display-inline">Each plan year, group health plans, including with respect to group health insurance coverage offered in connection with a group health plan, shall provide to each participant or beneficiary written notice informing the participant or beneficiary of the requirement for entities providing pharmacy benefit management services on behalf of the group health plan or health insurance issuer offering group health insurance coverage to submit reports to group health plans under paragraph (1), as applicable, which may include incorporating such notification in plan documents provided to the participant or beneficiary, or providing individual notification. </text></subparagraph><subparagraph commented="no" id="H4E54FA583EBB461FAB9A788DAF4908A3"><enum>(E)</enum><header>Limitation to business associates</header><text>A group health plan receiving a report under paragraph (1) may disclose such information only to the entity from which the report was received or to that entity’s business associates as defined in section 160.103 of title 45, Code of Federal Regulations (or successor regulations) or as permitted by the HIPAA privacy regulations.</text></subparagraph><subparagraph id="H5E26E1AB65F64C75BC974455AA4D8837"><enum>(F)</enum><header>Clarification regarding public disclosure of information</header><text>Nothing in this section shall prevent an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage, from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph (1), except that such plan, issuer, or entity may not—</text><clause commented="no" display-inline="no-display-inline" id="HAA65EB1EF2C94A408B414274DCCE06B4"><enum>(i)</enum><text display-inline="yes-display-inline">restrict disclosure of such report to the Department of Health and Human Services, the Department of Labor, or the Department of the Treasury; or</text></clause><clause commented="no" display-inline="no-display-inline" id="H594F716C281148E9A1F82DF8A139BC1C"><enum>(ii)</enum><text>prevent disclosure for the purposes of subsection (c), or any other public disclosure requirement under this section. </text></clause></subparagraph><subparagraph id="HA6AE7DC7EB2E497D8AE1DF51882C743E"><enum>(G)</enum><header>Limited form of report</header><text>The Secretary shall define through rulemaking a limited form of the report under paragraph (1) required with respect to any group health plan established by a plan sponsor that is, or is affiliated with, a drug manufacturer, drug wholesaler, or other direct participant in the drug supply chain, in order to prevent anti-competitive behavior.</text></subparagraph></paragraph><paragraph id="HE0EB8962D7044E3CAFB29D5878B8BE9E"><enum>(5)</enum><header>Standard format and regulations</header><subparagraph id="H8C2C629C9AD3472EB1D99DBC832A0D72"><enum>(A)</enum><header>In general</header><text>Not later than 18 months after the date of enactment of this section, the Secretary shall specify through rulemaking a standard format for entities providing pharmacy benefit management services on behalf of group health plans and health insurance issuers offering group health insurance coverage, to submit reports required under paragraph (1).</text></subparagraph><subparagraph id="HA78469C6F57047839DB3D92B5EA9517D"><enum>(B)</enum><header>Additional regulations</header><text>Not later than 18 months after the date of enactment of this section, the Secretary shall, through rulemaking, promulgate any other final regulations necessary to implement the requirements of this section. In promulgating such regulations, the Secretary shall, to the extent practicable, align the reporting requirements under this section with the reporting requirements under section 2799A–10.</text></subparagraph></paragraph></subsection><subsection id="H63FF8EB94CDD4E6787571F84C820E0A6"><enum>(c)</enum><header>Requirement To provide information to participants or beneficiaries</header><text>A group health plan, including with respect to group health insurance coverage offered in connection with a group health plan, upon request of a participant or beneficiary, shall provide to such participant or beneficiary—</text><paragraph commented="no" display-inline="no-display-inline" id="H07020076EAA443C5B91CE8D315723391"><enum>(1)</enum><text display-inline="yes-display-inline">the summary document described in subsection (b)(2)(B)(ii); and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HAB6F871808B84E87B727E50D7CEA2012"><enum>(2)</enum><text display-inline="yes-display-inline">the information described in subsection (b)(2)(A)(i)(III) with respect to a claim made by or on behalf of such participant or beneficiary. </text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H4FF3F31B95EB4BAE8FE93C209BB5C458"><enum>(d)</enum><header>Enforcement</header><paragraph id="H804514E53FFD4FC7B45A396F7D7CFF71"><enum>(1)</enum><header>In general</header><text>The Secretary shall enforce this section. The enforcement authority under this subsection shall apply only with respect to group health plans (including group health insurance coverage offered in connection with such a plan) to which the requirements of subparts I and II of part A and part D apply in accordance with section 2722, and with respect to entities providing pharmacy benefit management services on behalf of such plans and applicable entities providing services on behalf of such plans.</text></paragraph><paragraph commented="no" id="H1125543B52E24F29BE05A030E5129405"><enum>(2)</enum><header>Failure to provide information</header><text>A group health plan, a health insurance issuer offering group health insurance coverage, an entity providing pharmacy benefit management services on behalf of such a plan or issuer, or an applicable entity providing services on behalf of such a plan or issuer that violates subsection (a); an entity providing pharmacy benefit management services on behalf of such a plan or issuer that fails to provide the information required under subsection (b); or a group health plan that fails to provide the information required under subsection (c), shall be subject to a civil monetary penalty in the amount of $10,000 for each day during which such violation continues or such information is not disclosed or reported.</text></paragraph><paragraph id="HE6F44C8B64B842C483582A452DCDE720"><enum>(3)</enum><header>False information</header><text>A health insurance issuer, an entity providing pharmacy benefit management services, or a third party administrator providing services on behalf of such issuer offered by a health insurance issuer that knowingly provides false information under this section shall be subject to a civil monetary penalty in an amount not to exceed $100,000 for each item of false information. Such civil monetary penalty shall be in addition to other penalties as may be prescribed by law.</text></paragraph><paragraph id="H722D555DB49C4F30ABF1F791ABB9A22D"><enum>(4)</enum><header>Procedure</header><text>The provisions of section 1128A of the Social Security Act, other than subsections (a) and (b) and the first sentence of subsection (c)(1) of such section shall apply to civil monetary penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under such section.</text></paragraph><paragraph id="H1FE808D82326488991777FF0F1C653AF"><enum>(5)</enum><header>Waivers</header><text>The Secretary may waive penalties under paragraph (2), or extend the period of time for compliance with a requirement of this section, for an entity in violation of this section that has made a good-faith effort to comply with the requirements in this section.</text></paragraph></subsection><subsection id="HD7AE3C919BAF4816B77913E7000AAC32"><enum>(e)</enum><header>Rule of construction</header><text>Nothing in this section shall be construed to permit a health insurance issuer, group health plan, entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer, or other entity to restrict disclosure to, or otherwise limit the access of, the Secretary to a report described in subsection (b)(1) or information related to compliance with subsections (a), (b), (c), or (d) by such issuer, plan, or entity. </text></subsection><subsection commented="no" id="H1CAB6D56F4674B14B4BFBF35BB5E3AB1"><enum>(f)</enum><header>Definitions</header><text>In this section:</text><paragraph commented="no" id="H034B6A68C2414520BB491A9E5E26E848"><enum>(1)</enum><header>Applicable entity</header><text>The term <term>applicable entity</term> means—</text><subparagraph commented="no" id="HBEBE641A88CD4378A6DA6D4537100D88"><enum>(A)</enum><text>an applicable group purchasing organization, drug manufacturer, distributor, wholesaler, rebate aggregator (or other purchasing entity designed to aggregate rebates), or associated third party;</text></subparagraph><subparagraph commented="no" id="HDBFC1CC1461B460F8466224680B03BD1"><enum>(B)</enum><text>any subsidiary, parent, affiliate, or subcontractor of a group health plan, health insurance issuer, entity that provides pharmacy benefit management services on behalf of such a plan or issuer, or any entity described in subparagraph (A); or</text></subparagraph><subparagraph commented="no" id="H6FEB6E08EC58489C94FEC7440116FA54"><enum>(C)</enum><text>such other entity as the Secretary may specify through rulemaking.</text></subparagraph></paragraph><paragraph commented="no" id="H8F4F5DD89F444822A93FD7720A4F0027"><enum>(2)</enum><header>Applicable group purchasing organization</header><text>The term <term>applicable group purchasing organization</term> means a group purchasing organization that is affiliated with or under common ownership with an entity providing pharmacy benefit management services.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3EAFF127EB6B49B780CF5D0DCA5E8E1E"><enum>(3)</enum><header display-inline="yes-display-inline">Contracted compensation</header><text display-inline="yes-display-inline">The term <term>contracted compensation</term> means the sum of any ingredient cost and dispensing fee for a drug (inclusive of the out-of-pocket costs to the participant or beneficiary), or another analogous compensation structure that the Secretary may specify through regulations. </text></paragraph><paragraph commented="no" id="H8D359CFA7AF44AD48FDD1FEFEB939B94"><enum>(4)</enum><header>Gross spending</header><text>The term <term>gross spending</term>, with respect to prescription drug benefits under a group health plan or health insurance coverage, means the amount spent by a group health plan or health insurance issuer on prescription drug benefits, calculated before the application of rebates, fees, alternative discounts, or other remuneration.</text></paragraph><paragraph commented="no" id="H183FA0D42B5941729510D5616C1D21F8"><enum>(5)</enum><header>Net spending</header><text>The term <term>net spending</term>, with respect to prescription drug benefits under a group health plan or health insurance coverage, means the amount spent by a group health plan or health insurance issuer on prescription drug benefits, calculated after the application of rebates, fees, alternative discounts, or other remuneration.</text></paragraph><paragraph commented="no" id="H55455BAFDDCA4CEE849D7914B9A80B06"><enum>(6)</enum><header>Plan sponsor</header><text>The term <term>plan sponsor</term> has the meaning given such term in section 3(16)(B) of the Employee Retirement Income Security Act of 1974.</text></paragraph><paragraph commented="no" id="H49E3F3FA44DA4BF28DD49CCC2498F967"><enum>(7)</enum><header>Remuneration</header><text>The term <term>remuneration</term> has the meaning given such term by the Secretary through rulemaking, which shall be reevaluated by the Secretary every 5 years.</text></paragraph><paragraph commented="no" id="H0477A9775B6145DFB3842B019FABAF60"><enum>(8)</enum><header>Specified large employer</header><text>The term <term>specified large employer</term> means, in connection with a group health plan (including group health insurance coverage offered in connection with such a plan) established or maintained by a single employer, with respect to a calendar year or a plan year, as applicable, an employer who employed an average of at least 100 employees on business days during the preceding calendar year or plan year and who employs at least 1 employee on the first day of the calendar year or plan year. </text></paragraph><paragraph commented="no" id="H4BC558EF34AC40EE9E78474B85A0EE38"><enum>(9)</enum><header>Specified large plan</header><text>The term <term>specified large plan</term> means a group health plan (including group health insurance coverage offered in connection with such a plan) established or maintained by a plan sponsor described in clause (ii) or (iii) of section 3(16)(B) of the Employee Retirement Income Security Act of 1974 that had an average of at least 100 participants on business days during the preceding calendar year or plan year, as applicable. </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HED99BD6DA5CA4EBFA8BE2130F4677C7B"><enum>(10)</enum><header display-inline="yes-display-inline">Wholesale acquisition cost</header><text>The term <term>wholesale acquisition cost</term> has the meaning given such term in section 1847A(c)(6)(B) of the Social Security Act.</text></paragraph></subsection></section><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="HABCE3BA7787845D39E9CEF7DE2553B21"><enum>(2)</enum><text>in section 2723 (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-22">42 U.S.C. 300gg–22</external-xref>)—</text><subparagraph id="H9008FE4582744A8F93DE4BA03057881A"><enum>(A)</enum><text>in subsection (a)—</text><clause id="HEB409F4C90C94CB9AAE6B45C391DB967"><enum>(i)</enum><text>in paragraph (1), by inserting <quote>(other than section 2799A–11)</quote> after <quote>part D</quote>; and</text></clause><clause id="HAD2A58BBB17342668D004267669E6353"><enum>(ii)</enum><text>in paragraph (2), by inserting <quote>(other than section 2799A–11)</quote> after <quote>part D</quote>; and</text></clause></subparagraph><subparagraph id="H614B4F18D524482581DD6AD33A03E19E"><enum>(B)</enum><text>in subsection (b)—</text><clause id="HEEF293ECF2044FB0822DE04CDCFA19F6"><enum>(i)</enum><text>in paragraph (1), by inserting <quote>(other than section 2799A–11)</quote> after <quote>part D</quote>;</text></clause><clause id="H0A8FE0903D3D4CF1AB75EDC151DF1374"><enum>(ii)</enum><text>in paragraph (2)(A), by inserting <quote>(other than section 2799A–11)</quote> after <quote>part D</quote>; and</text></clause><clause id="H122149DADDF049778C520EEAA48F9FEE"><enum>(iii)</enum><text>in paragraph (2)(C)(ii), by inserting <quote>(other than section 2799A–11)</quote> after <quote>part D</quote>.</text></clause></subparagraph></paragraph></subsection><subsection id="H1D76A0969BDA4B54824F0CA9E5B3BD96"><enum>(b)</enum><header>Employee Retirement Income Security Act of 1974</header><paragraph id="H41FB86E5BF694014BC7A2B75E51C123E"><enum>(1)</enum><header>In general</header><text>Subtitle B of title I of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1021">29 U.S.C. 1021 et seq.</external-xref>) is amended—</text><subparagraph id="HAE4FC13A6007423790C8607556C9786F"><enum>(A)</enum><text>in subpart B of part 7 (<external-xref legal-doc="usc" parsable-cite="usc/29/1185">29 U.S.C. 1185 et seq.</external-xref>), by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HBDB312E2843247A78B84D7881F331812"><section id="H1BA03E8B739D470CBBEB656B5A60E3FF"><enum>726.</enum><header>Oversight of entities that provide pharmacy benefit management services</header><subsection id="H1C154DC103604CC9B5F5F408E3E0E1A3"><enum>(a)</enum><header>In general</header><text>For plan years beginning on or after the date that is 30 months after the date of enactment of this section (referred to in this subsection and subsection (b) as the <quote>effective date</quote>), a group health plan or a health insurance issuer offering group health insurance coverage, or an entity providing pharmacy benefit management services on behalf of such a plan or issuer, shall not enter into a contract, including an extension or renewal of a contract, entered into on or after the effective date, with an applicable entity unless such applicable entity agrees to—</text><paragraph id="H12F9F4ADC2884C5892CC628D715A59B9"><enum>(1)</enum><text>not limit or delay the disclosure of information to the group health plan (including such a plan offered through a health insurance issuer) in such a manner that prevents an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage from making the reports described in subsection (b); and</text></paragraph><paragraph id="HA9CD0E1F0BA64EBC95508AB8A43C1578"><enum>(2)</enum><text>provide the entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer relevant information necessary to make the reports described in subsection (b).</text></paragraph></subsection><subsection id="H50CD2E13E0EB4D53A7F5EC99CC457E8E"><enum>(b)</enum><header>Reports</header><paragraph id="H83AEAF1F586A45F29192420BC664A335"><enum>(1)</enum><header>In general</header><text>For plan years beginning on or after the effective date, in the case of any contract between a group health plan or a health insurance issuer offering group health insurance coverage offered in connection with such a plan and an entity providing pharmacy benefit management services on behalf of such plan or issuer, including an extension or renewal of such a contract, entered into on or after the effective date, the entity providing pharmacy benefit management services on behalf of such a group health plan or health insurance issuer, not less frequently than every 6 months (or, at the request of a group health plan, not less frequently than quarterly, and under the same conditions, terms, and cost of the semiannual report under this subsection), shall submit to the group health plan a report in accordance with this section. Each such report shall be made available to such group health plan in plain language, in a machine-readable format, and as the Secretary may determine, other formats. Each such report shall include the information described in paragraph (2).</text></paragraph><paragraph id="H20006799FA5A4592B0D389D2EFFA6D07"><enum>(2)</enum><header>Information described</header><text>For purposes of paragraph (1), the information described in this paragraph is, with respect to drugs covered by a group health plan or group health insurance coverage offered by a health insurance issuer in connection with a group health plan during each reporting period—</text><subparagraph id="H0D1905FF9D5F418E83822E77F6C73303"><enum>(A)</enum><text>in the case of a group health plan that is offered by a specified large employer or that is a specified large plan, and is not offered as health insurance coverage, or in the case of health insurance coverage for which the election under paragraph (3) is made for the applicable reporting period—</text><clause id="H509C46D96242481E948019A74762343E"><enum>(i)</enum><text>a list of drugs for which a claim was filed and, with respect to each such drug on such list—</text><subclause id="HF603E3DE8F8B4070A8875B62264BF2C0"><enum>(I)</enum><text>the contracted compensation paid by the group health plan or health insurance issuer for each covered drug (identified by the National Drug Code) to the entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan or health insurance issuer;</text></subclause><subclause id="H21C3A47F8F624994B568BB8A55032E5E"><enum>(II)</enum><text>the contracted compensation paid to the pharmacy, by any entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan or health insurance issuer, for each covered drug (identified by the National Drug Code);</text></subclause><subclause id="H9E29AF27C672497DBF054E86C32CA505"><enum>(III)</enum><text>for each such claim, the difference between the amount paid under subclause (I) and the amount paid under subclause (II);</text></subclause><subclause id="H7A1F601FE5034BE7AA82951338F1AA68"><enum>(IV)</enum><text>the proprietary name, established name or proper name, and National Drug Code;</text></subclause><subclause id="H92C0B0B14A2942DB9456C6C5070AF81A"><enum>(V)</enum><text>for each claim for the drug (including original prescriptions and refills) and for each dosage unit of the drug for which a claim was filed, the type of dispensing channel used to furnish the drug, including retail, mail order, or specialty pharmacy;</text></subclause><subclause id="H05825BA45C0641A0AD05D2FEEE932E3A"><enum>(VI)</enum><text>with respect to each drug dispensed, for each type of dispensing channel (including retail, mail order, or specialty pharmacy)—</text><item commented="no" display-inline="no-display-inline" id="H007EDFADA34C40B9BD996F91C0EC131C"><enum>(aa)</enum><text display-inline="yes-display-inline">whether such drug is a brand name drug or a generic drug, and—</text><subitem id="H88BDA947AD464782AA96C60314DC8AAD"><enum>(AA)</enum><text>in the case of a brand name drug, the wholesale acquisition cost, listed as cost per days supply and cost per dosage unit, on the date such drug was dispensed; and</text></subitem><subitem id="HD8A6E1E2344D440CA124800E2A3BDE0D"><enum>(BB)</enum><text>in the case of a generic drug, the average wholesale price, listed as cost per days supply and cost per dosage unit, on the date such drug was dispensed; and</text></subitem></item><item id="HA36E0AFC12F74E0D8272D8B065FA3ED4"><enum>(bb)</enum><text>the total number of—</text><subitem id="H5DCEBBA4619F458486DE4ECF4176ECAC"><enum>(AA)</enum><text>prescription claims (including original prescriptions and refills);</text></subitem><subitem id="H2A89A7FDAB1C435EAFC917B2746BB4F8"><enum>(BB)</enum><text>participants and beneficiaries for whom a claim for such drug was filed through the applicable dispensing channel;</text></subitem><subitem id="H32FA27E19CAF43D18CB0CC241D476818"><enum>(CC)</enum><text>dosage units and dosage units per fill of such drug; and</text></subitem><subitem id="H28B302C3333F49D79618171F5ED4C58B"><enum>(DD)</enum><text>days supply of such drug per fill;</text></subitem></item></subclause><subclause id="HFEA72A7714F942309BC7163B0CB65141"><enum>(VII)</enum><text>the net price per course of treatment or single fill, such as a 30-day supply or 90-day supply to the plan or coverage after rebates, fees, alternative discounts, or other remuneration received from applicable entities;</text></subclause><subclause id="H7A09EBBD5BFA46808333FB3EBA32840C"><enum>(VIII)</enum><text>the total amount of out-of-pocket spending by participants and beneficiaries on such drug, including spending through copayments, coinsurance, and deductibles, but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage, or for which no claim is submitted under the plan or coverage;</text></subclause><subclause commented="no" id="HAFE6BF838E4A4589B8CFC1FEC3493C5E"><enum>(IX)</enum><text>the total net spending on the drug;</text></subclause><subclause id="H83CA66B109CC4AF39528A026761107AD"><enum>(X)</enum><text>the total amount received, or expected to be received, by the plan or issuer from any applicable entity in rebates, fees, alternative discounts, or other remuneration;</text></subclause><subclause id="H88ABAB5783F54351BEEAA3E99C3C121B"><enum>(XI)</enum><text>the total amount received, or expected to be received, by the entity providing pharmacy benefit management services, from applicable entities, in rebates, fees, alternative discounts, or other remuneration from such entities— </text><item commented="no" display-inline="no-display-inline" id="HFB69ED289AA24AAF9F7ED343D048DE7A"><enum>(aa)</enum><text display-inline="yes-display-inline">for claims incurred during the reporting period; and</text></item><item commented="no" display-inline="no-display-inline" id="HABFD5A45CE27430C950088DC05365154"><enum>(bb)</enum><text display-inline="yes-display-inline">that is related to utilization of such drug or spending on such drug; and</text></item></subclause><subclause id="H5E4FA54FCD114E798B1D1F98081B265E"><enum>(XII)</enum><text>to the extent feasible, information on the total amount of remuneration for such drug, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copayment assistance on behalf of such drug manufacturer), to the participants and beneficiaries enrolled in such plan or coverage;</text></subclause></clause><clause id="HA64CC186A60B48D8B55C9A063F4A4255"><enum>(ii)</enum><text>a list of each therapeutic class (as defined by the Secretary) for which a claim was filed under the group health plan or health insurance coverage during the reporting period, and, with respect to each such therapeutic class—</text><subclause id="H0D7A4CE538D6459E8DE46D18C70C62B5"><enum>(I)</enum><text>the total gross spending on drugs in such class before rebates, price concessions, alternative discounts, or other remuneration from applicable entities; </text></subclause><subclause id="H57662EB00FC14F37A2E4477AB3BDAE06"><enum>(II)</enum><text>the net spending in such class after such rebates, price concessions, alternative discounts, or other remuneration from applicable entities;</text></subclause><subclause id="HF22742CB72964577B49EDD7ADC734BAC"><enum>(III)</enum><text>the total amount received, or expected to be received, by the entity providing pharmacy benefit management services, from applicable entities, in rebates, fees, alternative discounts, or other remuneration from such entities— </text><item commented="no" display-inline="no-display-inline" id="H96953F66AC03477C8C290DA7018FE5B8"><enum>(aa)</enum><text display-inline="yes-display-inline">for claims incurred during the reporting period; and</text></item><item commented="no" display-inline="no-display-inline" id="HE4A86E20B66C446BADA3A2D1D597F669"><enum>(bb)</enum><text display-inline="yes-display-inline">that is related to utilization of drugs or drug spending;</text></item></subclause><subclause id="HEA53E1975F3B459DB83AF20A58E516B0"><enum>(IV)</enum><text>the average net spending per 30-day supply and per 90-day supply by the plan or by the issuer with respect to such coverage and its participants and beneficiaries, among all drugs within the therapeutic class for which a claim was filed during the reporting period;</text></subclause><subclause id="HD54802BA13184300B8E28DA96B30A729"><enum>(V)</enum><text>the number of participants and beneficiaries who filled a prescription for a drug in such class, including the National Drug Code for each such drug;</text></subclause><subclause id="H3F2E0444BE1647CC9B82D7A2DEB4EEE6"><enum>(VI)</enum><text>if applicable, a description of the formulary tiers and utilization mechanisms (such as prior authorization or step therapy) employed for drugs in that class; and</text></subclause><subclause id="HF9134A4275CD4AC3BF825A54DA621CF7"><enum>(VII)</enum><text>the total out-of-pocket spending under the plan or coverage by participants and beneficiaries, including spending through copayments, coinsurance, and deductibles, but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage or for which no claim is submitted under the plan or coverage;</text></subclause></clause><clause id="HF30347D9F4074F6692F5EE2554749594"><enum>(iii)</enum><text>with respect to any drug for which gross spending under the group health plan or health insurance coverage exceeded $10,000 during the reporting period or, in the case that gross spending under the group health plan or coverage exceeded $10,000 during the reporting period with respect to fewer than 50 drugs, with respect to the 50 prescription drugs with the highest spending during the reporting period—</text><subclause commented="no" display-inline="no-display-inline" id="HBDA01FDB3AF9421AA6F850D00DBE42DF"><enum>(I)</enum><text display-inline="yes-display-inline">a list of all other drugs in the same therapeutic class as such drug; </text></subclause><subclause commented="no" display-inline="no-display-inline" id="H4E6B6FB08A4E46A7B008CFA3CA68329C"><enum>(II)</enum><text display-inline="yes-display-inline">if applicable, the rationale for the formulary placement of such drug in that therapeutic category or class, selected from a list of standard rationales established by the Secretary, in consultation with stakeholders; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H0C4B30487C0242E1B9CE9CD5C8102E12"><enum>(III)</enum><text display-inline="yes-display-inline">any change in formulary placement compared to the prior plan year; and</text></subclause></clause><clause id="HBF4C550CD76C48CA87C8523E9CBC91AB"><enum>(iv)</enum><text>in the case that such plan or issuer (or an entity providing pharmacy benefit management services on behalf of such plan or issuer) has an affiliated pharmacy or pharmacy under common ownership, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost sharing assistance incentives funded by an entity providing pharmacy benefit services—</text><subclause id="H15FD734C2CFA4C87A1D248B6E36FF8C3"><enum>(I)</enum><text>an explanation of any benefit design parameters that encourage or require participants and beneficiaries in the plan or coverage to fill prescriptions at mail order, specialty, or retail pharmacies;</text></subclause><subclause id="H21A6CBD8522240F9AE8684D023E0128E"><enum>(II)</enum><text>the percentage of total prescriptions dispensed by such pharmacies to participants or beneficiaries in such plan or coverage; and</text></subclause><subclause id="H79A6D014E30D48BB9F9032E28EFF90EC"><enum>(III)</enum><text>a list of all drugs dispensed by such pharmacies to participants or beneficiaries enrolled in such plan or coverage, and, with respect to each drug dispensed—</text><item id="HB05CAF07F52E42A082ED74DB2BBFD8CA"><enum>(aa)</enum><text>the amount charged, per dosage unit, per 30-day supply, or per 90-day supply (as applicable) to the plan or issuer, and to participants and beneficiaries;</text></item><item id="H3DC3F9ED4BFD4228B18B2BFA1EFDC638"><enum>(bb)</enum><text>the median amount charged to such plan or issuer, and the interquartile range of the costs, per dosage unit, per 30-day supply, and per 90-day supply, including amounts paid by the participants and beneficiaries, when the same drug is dispensed by other pharmacies that are not affiliated with or under common ownership with the entity and that are included in the pharmacy network of such plan or coverage;</text></item><item id="HAEDA98284C004B579F1151E25A315D69"><enum>(cc)</enum><text>the lowest cost per dosage unit, per 30-day supply and per 90-day supply, for each such drug, including amounts charged to the plan or coverage and to participants and beneficiaries, that is available from any pharmacy included in the network of such plan or coverage; and</text></item><item id="HF9D3A0F2FD5C44BAAB8E37C1E4DCB673"><enum>(dd)</enum><text>the net acquisition cost per dosage unit, per 30-day supply, and per 90-day supply, if such drug is subject to a maximum price discount; and</text></item></subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H90CAC8D835E244F4BE0E682813E013D3"><enum>(B)</enum><text>with respect to any group health plan, including group health insurance coverage offered in connection with such a plan, regardless of whether the plan or coverage is offered by a specified large employer or whether it is a specified large plan—</text><clause commented="no" display-inline="no-display-inline" id="H36A535DC265541308300348745AB6672"><enum>(i)</enum><text display-inline="yes-display-inline">a summary document for the group health plan that includes such information described in clauses (i) through (iv) of subparagraph (A), as specified by the Secretary through guidance, program instruction, or otherwise (with no requirement of notice and comment rulemaking), that the Secretary determines useful to group health plans for purposes of selecting pharmacy benefit management services, such as an estimated net price to group health plan and participant or beneficiary, a cost per claim, the fee structure or reimbursement model, and estimated cost per participant or beneficiary; </text></clause><clause commented="no" display-inline="no-display-inline" id="H725E4844FFA24FF39051777A7A95FC6F"><enum>(ii)</enum><text display-inline="yes-display-inline">a summary document for plans and issuers to provide to participants and beneficiaries, which shall be made available to participants or beneficiaries upon request to their group health plan (including in the case of group health insurance coverage offered in connection with such a plan), that—</text><subclause commented="no" display-inline="no-display-inline" id="H932093B22D17470D8C92911E90243E72"><enum>(I)</enum><text>contains such information described in clauses (iii), (iv), (v), and (vi), as applicable, as specified by the Secretary through guidance, program instruction, or otherwise (with no requirement of notice and comment rulemaking) that the Secretary determines useful to participants or beneficiaries in better understanding the plan or coverage or benefits under such plan or coverage; </text></subclause><subclause commented="no" display-inline="no-display-inline" id="HB1C5BB03E69F4952ACEF900744727C12"><enum>(II)</enum><text display-inline="yes-display-inline">contains only aggregate information; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H71D5876E4CBD418C9B3820A0A32FA1CA"><enum>(III)</enum><text display-inline="yes-display-inline">states that participants and beneficiaries may request specific, claims-level information required to be furnished under subsection (c) from the group health plan or health insurance issuer; and</text></subclause></clause><clause id="H4C6F94B8076F4B728F45CAE37C61171D"><enum>(iii)</enum><text>with respect to drugs covered by such plan or coverage during such reporting period—</text><subclause id="H856260116FFF4D3798F4C23A3983665A"><enum>(I)</enum><text>the total net spending by the plan or coverage for all such drugs;</text></subclause><subclause id="HFB1EEAC065474514A813C73867EE3633"><enum>(II)</enum><text>the total amount received, or expected to be received, by the plan or issuer from any applicable entity in rebates, fees, alternative discounts, or other remuneration; and</text></subclause><subclause id="H779BB098B38D404C9ADFF3FE1B6DA783"><enum>(III)</enum><text>to the extent feasible, information on the total amount of remuneration for such drugs, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copayment assistance on behalf of such drug manufacturer) to participants and beneficiaries;</text></subclause></clause><clause id="HE8D8C7E72CF545029142C89F4A4E8840"><enum>(iv)</enum><text>amounts paid directly or indirectly in rebates, fees, or any other type of compensation (as defined in section 408(b)(2)(B)(ii)(dd)(AA)) to brokerage firms, brokers, consultants, advisors, or any other individual or firm, for—</text><subclause id="HFD13E1AA4C9E40A79109AD0889A31D30"><enum>(I)</enum><text>the referral of the group health plan's or health insurance issuer's business to an entity providing pharmacy benefit management services, including the identity of the recipient of such amounts;</text></subclause><subclause id="H108C7C4D7EF24EBFA34A6E8EB8C3FC88"><enum>(II)</enum><text>consideration of the entity providing pharmacy benefit management services by the group health plan or health insurance issuer; or</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HDECC002A78534848BAD9F0710D059244"><enum>(III)</enum><text display-inline="yes-display-inline">the retention of the entity by the group health plan or health insurance issuer;</text></subclause></clause><clause id="HC819C0A6443746FD817EE86F0994B802"><enum>(v)</enum><text>an explanation of any benefit design parameters that encourage or require participants and beneficiaries in such plan or coverage to fill prescriptions at mail order, specialty, or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services under such plan or coverage, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost-sharing assistance incentives directly or indirectly funded by such entity; and</text></clause><clause id="H8A0449F398D84A73ABD5F255830FC12C"><enum>(vi)</enum><text>total gross spending on all drugs under the plan or coverage during the reporting period.</text></clause></subparagraph></paragraph><paragraph commented="no" id="HC094CE5FDCF945049D1517194BC20243"><enum>(3)</enum><header>Opt-in for group health insurance coverage offered by a specified large employer or that is a specified large plan</header><text>In the case of group health insurance coverage offered in connection with a group health plan that is offered by a specified large employer or is a specified large plan, such group health plan may, on an annual basis, for plan years beginning on or after the date that is 30 months after the date of enactment of this section, elect to require an entity providing pharmacy benefit management services on behalf of the health insurance issuer to submit to such group health plan a report that includes all of the information described in paragraph (2)(A), in addition to the information described in paragraph (2)(B).</text></paragraph><paragraph id="H2C09150AD0F24B21AA1BB54DB0F13D9A"><enum>(4)</enum><header>Privacy requirements</header><subparagraph id="HF5F090FB6D5D478DA4B5CA2D267D72D7"><enum>(A)</enum><header>In general</header><text>An entity providing pharmacy benefit management services on behalf of a group health plan or a health insurance issuer offering group health insurance coverage shall report information under paragraph (1) in a manner consistent with the privacy regulations promulgated under section 13402(a) of the Health Information Technology for Economic and Clinical Health Act (<external-xref legal-doc="usc" parsable-cite="usc/42/17932">42 U.S.C. 17932(a)</external-xref>) and consistent with the privacy regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 in part 160 and subparts A and E of part 164 of title 45, Code of Federal Regulations (or successor regulations) (referred to in this paragraph as the <quote>HIPAA privacy regulations</quote>) and shall restrict the use and disclosure of such information according to such privacy regulations and such HIPAA privacy regulations. </text></subparagraph><subparagraph id="H95D4E3DD66AB40C88FD4EF3A602C462F"><enum>(B)</enum><header>Additional requirements</header><clause id="H8984B5C5EE3947C9A30FD5914F1324B3"><enum>(i)</enum><header>In general</header><text>An entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage that submits a report under paragraph (1) shall ensure that such report contains only summary health information, as defined in section 164.504(a) of title 45, Code of Federal Regulations (or successor regulations).</text></clause><clause id="HAF2070826BA544BA92462C468ACE9DC4"><enum>(ii)</enum><header>Restrictions</header><text>In carrying out this subsection, a group health plan shall comply with section 164.504(f) of title 45, Code of Federal Regulations (or a successor regulation), and a plan sponsor shall act in accordance with the terms of the agreement described in such section.</text></clause></subparagraph><subparagraph id="HF025B6FE767E4F4E887764D0C0F3CDCF"><enum>(C)</enum><header>Rule of construction</header><clause commented="no" display-inline="no-display-inline" id="HA44EFCC13F2D46E09AB5EC4838CFD21F"><enum>(i)</enum><text display-inline="yes-display-inline">Nothing in this section shall be construed to modify the requirements for the creation, receipt, maintenance, or transmission of protected health information under the HIPAA privacy regulations. </text></clause><clause commented="no" display-inline="no-display-inline" id="H5A897AF0BB444C819C4CB7C542B1C3DD"><enum>(ii)</enum><text display-inline="yes-display-inline">Nothing in this section shall be construed to affect the application of any Federal or State privacy or civil rights law, including the HIPAA privacy regulations, the Genetic Information Nondiscrimination Act of 2008 (<external-xref legal-doc="public-law" parsable-cite="pl/110/233">Public Law 110–233</external-xref>) (including the amendments made by such Act), the Americans with Disabilities Act of 1990 (<external-xref legal-doc="usc" parsable-cite="usc/42/12101">42 U.S.C. 12101 et seq.</external-xref>), section 504 of the Rehabilitation Act of 1973 (<external-xref legal-doc="usc" parsable-cite="usc/29/794">29 U.S.C. 794</external-xref>), section 1557 of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18116">42 U.S.C. 18116</external-xref>), title VI of the Civil Rights Act of 1964 (<external-xref legal-doc="usc" parsable-cite="usc/42/2000d">42 U.S.C. 2000d</external-xref>), and title VII of the Civil Rights Act of 1964 (<external-xref legal-doc="usc" parsable-cite="usc/42/2000e">42 U.S.C. 2000e</external-xref>). </text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H2A528ED5DCB4414BA9892E7EAC6FCB05"><enum>(D)</enum><header>Written notice</header><text display-inline="yes-display-inline">Each plan year, group health plans, including with respect to group health insurance coverage offered in connection with a group health plan, shall provide to each participant or beneficiary written notice informing the participant or beneficiary of the requirement for entities providing pharmacy benefit management services on behalf of the group health plan or health insurance issuer offering group health insurance coverage to submit reports to group health plans under paragraph (1), as applicable, which may include incorporating such notification in plan documents provided to the participant or beneficiary, or providing individual notification. </text></subparagraph><subparagraph commented="no" id="H10907649B7FC4F51A2770BD66BD79651"><enum>(E)</enum><header>Limitation to business associates</header><text>A group health plan receiving a report under paragraph (1) may disclose such information only to the entity from which the report was received or to that entity’s business associates as defined in section 160.103 of title 45, Code of Federal Regulations (or successor regulations) or as permitted by the HIPAA privacy regulations.</text></subparagraph><subparagraph id="H6474A87BA9CC4BCCBEC0A147B00CC528"><enum>(F)</enum><header>Clarification regarding public disclosure of information</header><text>Nothing in this section shall prevent an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage, from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph (1), except that such plan, issuer, or entity may not—</text><clause commented="no" display-inline="no-display-inline" id="H56AFC5BEF3AC45FE946705E952BEE7C7"><enum>(i)</enum><text display-inline="yes-display-inline">restrict disclosure of such report to the Department of Health and Human Services, the Department of Labor, or the Department of the Treasury; or</text></clause><clause commented="no" display-inline="no-display-inline" id="H1AE63B33DF8845F6A3417C5A26F43431"><enum>(ii)</enum><text>prevent disclosure for the purposes of subsection (c), or any other public disclosure requirement under this section. </text></clause></subparagraph><subparagraph id="H434133A98DA342398838F875D3FD51A0"><enum>(G)</enum><header>Limited form of report</header><text>The Secretary shall define through rulemaking a limited form of the report under paragraph (1) required with respect to any group health plan established by a plan sponsor that is, or is affiliated with, a drug manufacturer, drug wholesaler, or other direct participant in the drug supply chain, in order to prevent anti-competitive behavior.</text></subparagraph></paragraph><paragraph id="HB51B122101FA4342B741539111D7855C"><enum>(5)</enum><header>Standard format and regulations</header><subparagraph id="H7FFB3EE1E4EE431AB02768A3AF391CC5"><enum>(A)</enum><header>In general</header><text>Not later than 18 months after the date of enactment of this section, the Secretary shall specify through rulemaking a standard format for entities providing pharmacy benefit management services on behalf of group health plans and health insurance issuers offering group health insurance coverage, to submit reports required under paragraph (1).</text></subparagraph><subparagraph id="H4C786C09392041319A42150ACD40D7A4"><enum>(B)</enum><header>Additional regulations</header><text>Not later than 18 months after the date of enactment of this section, the Secretary shall, through rulemaking, promulgate any other final regulations necessary to implement the requirements of this section. In promulgating such regulations, the Secretary shall, to the extent practicable, align the reporting requirements under this section with the reporting requirements under section 725.</text></subparagraph></paragraph></subsection><subsection id="HFCCA948D0A914E5295A9950A5900CBDB"><enum>(c)</enum><header>Requirement To provide information to participants or beneficiaries</header><text>A group health plan, including with respect to group health insurance coverage offered in connection with a group health plan, upon request of a participant or beneficiary, shall provide to such participant or beneficiary—</text><paragraph commented="no" display-inline="no-display-inline" id="HC4F33CB892804557BC7B3028D10E5FB1"><enum>(1)</enum><text display-inline="yes-display-inline">the summary document described in subsection (b)(2)(B)(ii); and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HD99590838CE946D4900648A1DE469A70"><enum>(2)</enum><text display-inline="yes-display-inline">the information described in subsection (b)(2)(A)(i)(III) with respect to a claim made by or on behalf of such participant or beneficiary.</text></paragraph></subsection><subsection id="HB5FBF62BFF654142A05B38F6E0B28DBC"><enum>(d)</enum><header>Rule of construction</header><text>Nothing in this section shall be construed to permit a health insurance issuer, group health plan, entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer, or other entity to restrict disclosure to, or otherwise limit the access of, the Secretary to a report described in subsection (b)(1) or information related to compliance with subsections (a), (b), or (c) of this section or section 502(c)(13) by such issuer, plan, or entity. </text></subsection><subsection commented="no" id="H5279F52CDCEF47D690AEA8FAB85E6F70"><enum>(e)</enum><header>Definitions</header><text>In this section:</text><paragraph commented="no" id="H2ECE22D8486B4550AEF7A18A4DDE3E12"><enum>(1)</enum><header>Applicable entity</header><text>The term <term>applicable entity</term> means—</text><subparagraph commented="no" id="H5A95FAC5D96C48CBB3C4D5A84E508726"><enum>(A)</enum><text>an applicable group purchasing organization, drug manufacturer, distributor, wholesaler, rebate aggregator (or other purchasing entity designed to aggregate rebates), or associated third party;</text></subparagraph><subparagraph commented="no" id="HED205078E2EC4B56B2F4BEF4DAB82E3E"><enum>(B)</enum><text>any subsidiary, parent, affiliate, or subcontractor of a group health plan, health insurance issuer, entity that provides pharmacy benefit management services on behalf of such a plan or issuer, or any entity described in subparagraph (A); or</text></subparagraph><subparagraph commented="no" id="H8B022475CF184D6982E97F7FB8DD75C5"><enum>(C)</enum><text>such other entity as the Secretary may specify through rulemaking.</text></subparagraph></paragraph><paragraph commented="no" id="H9F448EAF598846D19C2357E5DA9DB0D8"><enum>(2)</enum><header>Applicable group purchasing organization</header><text>The term <term>applicable group purchasing organization</term> means a group purchasing organization that is affiliated with or under common ownership with an entity providing pharmacy benefit management services.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H3D5CEF72FEB14F9BAD44E1BD46942127"><enum>(3)</enum><header display-inline="yes-display-inline">Contracted compensation</header><text display-inline="yes-display-inline">The term <term>contracted compensation</term> means the sum of any ingredient cost and dispensing fee for a drug (inclusive of the out-of-pocket costs to the participant or beneficiary), or another analogous compensation structure that the Secretary may specify through regulations. </text></paragraph><paragraph commented="no" id="H93BAA8F24E87471EB27BA4993EA66B43"><enum>(4)</enum><header>Gross spending</header><text>The term <term>gross spending</term>, with respect to prescription drug benefits under a group health plan or health insurance coverage, means the amount spent by a group health plan or health insurance issuer on prescription drug benefits, calculated before the application of rebates, fees, alternative discounts, or other remuneration.</text></paragraph><paragraph commented="no" id="H607DF591684249FF85A1EC549C729F9A"><enum>(5)</enum><header>Net spending</header><text>The term <term>net spending</term>, with respect to prescription drug benefits under a group health plan or health insurance coverage, means the amount spent by a group health plan or health insurance issuer on prescription drug benefits, calculated after the application of rebates, fees, alternative discounts, or other remuneration.</text></paragraph><paragraph commented="no" id="H2383B77F78EE45DCBEA57FB4899F7C10"><enum>(6)</enum><header>Plan sponsor</header><text>The term <term>plan sponsor</term> has the meaning given such term in section 3(16)(B).</text></paragraph><paragraph commented="no" id="H01B4BD2938A840BB876D545FA489B587"><enum>(7)</enum><header>Remuneration</header><text>The term <term>remuneration</term> has the meaning given such term by the Secretary through rulemaking, which shall be reevaluated by the Secretary every 5 years.</text></paragraph><paragraph commented="no" id="HB97B97EB65934D23888756A589F00F13"><enum>(8)</enum><header>Specified large employer</header><text>The term <term>specified large employer</term> means, in connection with a group health plan (including group health insurance coverage offered in connection with such a plan) established or maintained by a single employer, with respect to a calendar year or a plan year, as applicable, an employer who employed an average of at least 100 employees on business days during the preceding calendar year or plan year and who employs at least 1 employee on the first day of the calendar year or plan year. </text></paragraph><paragraph commented="no" id="H2D8D1AFA7D76477DB8D5D71A28414E06"><enum>(9)</enum><header>Specified large plan</header><text>The term <term>specified large plan</term> means a group health plan (including group health insurance coverage offered in connection with such a plan) established or maintained by a plan sponsor described in clause (ii) or (iii) of section 3(16)(B) that had an average of at least 100 participants on business days during the preceding calendar year or plan year, as applicable. </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H72A26EE34FF745C68D5E5738507C80E4"><enum>(10)</enum><header display-inline="yes-display-inline">Wholesale acquisition cost</header><text>The term <term>wholesale acquisition cost</term> has the meaning given such term in section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)(B)).</text></paragraph></subsection></section><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="HF9A17D0BEE7D44FFBDD91576090CDCC5"><enum>(B)</enum><text>in section 502 (<external-xref legal-doc="usc" parsable-cite="usc/29/1132">29 U.S.C. 1132</external-xref>)—</text><clause commented="no" display-inline="no-display-inline" id="H928C7726C7004CBFB9D59ED49DE69BC6"><enum>(i)</enum><text>in subsection (a)(6), by striking <quote>or (9)</quote> and inserting <quote>(9), or (13)</quote>;</text></clause><clause commented="no" display-inline="no-display-inline" id="H2BEB0010113646AAB35984BD7761A016"><enum>(ii)</enum><text display-inline="yes-display-inline">in subsection (b)(3), by striking <quote>under subsection (c)(9)</quote> and inserting <quote>under paragraphs (9) and (13) of subsection (c)</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="H77F8B14524B2405583E5E31019BBF1E4"><enum>(iii)</enum><text>in subsection (c), by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H7A60B836082C4CBB9BA352B07CD49E56"><paragraph commented="no" id="H0339CC87F7374942A37AA7981A225165"><enum>(13)</enum><header>Secretarial enforcement authority relating to oversight of pharmacy benefit management services</header><subparagraph commented="no" display-inline="no-display-inline" id="H2FB5808C2EB64683BC0B41FD14BB078F"><enum>(A)</enum><header display-inline="yes-display-inline">Failure to provide information</header><text>The Secretary may impose a penalty against a plan administrator of a group health plan, a health insurance issuer offering group health insurance coverage, or an entity providing pharmacy benefit management services on behalf of such a plan or issuer, or an applicable entity (as defined in section 726(f)) that violates section 726(a); an entity providing pharmacy benefit management services on behalf of such a plan or issuer that fails to provide the information required under section 726(b); or any person who causes a group health plan to fail to provide the information required under section 726(c), in the amount of $10,000 for each day during which such violation continues or such information is not disclosed or reported.</text></subparagraph><subparagraph id="H87A64E66EF2041D0A143E4CAD1750962"><enum>(B)</enum><header>False information</header><text>The Secretary may impose a penalty against a plan administrator of a group health plan, a health insurance issuer offering group health insurance coverage, an entity providing pharmacy benefit management services, or an applicable entity (as defined in section 726(f)) that knowingly provides false information under section 726, in an amount not to exceed $100,000 for each item of false information. Such penalty shall be in addition to other penalties as may be prescribed by law.</text></subparagraph><subparagraph id="HA6535A08C8194D4C8FC592F2B9F635F0"><enum>(C)</enum><header>Waivers</header><text>The Secretary may waive penalties under subparagraph (A), or extend the period of time for compliance with a requirement of this section, for an entity in violation of section 726 that has made a good-faith effort to comply with the requirements of section 726.</text></subparagraph></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HC1D4A3F75A754378B0968FCA9A5C6515"><enum>(C)</enum><text>in section 732(a) (<external-xref legal-doc="usc" parsable-cite="usc/29/1191a">29 U.S.C. 1191a(a)</external-xref>), by striking <quote>section 711</quote> and inserting <quote>sections 711 and 726</quote>. </text></subparagraph></paragraph><paragraph id="H7FC88FDE46544F29BA7E61B7316F1EFF"><enum>(2)</enum><header>Clerical amendment</header><text>The table of contents in section 1 of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1001">29 U.S.C. 1001 et seq.</external-xref>) is amended by inserting after the item relating to section 725 the following new item:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H5B01899CC2694D5590408405F44FA9E2"><toc><toc-entry bold="off" level="section">Sec. 726. Oversight of entities that provide pharmacy benefit management services.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H59DCE6AC1C3F44C2927BEE296EC838DC"><enum>(c)</enum><header>Internal Revenue Code of 1986</header><paragraph id="H677F3593F21046B4BC6B278F4BBF4DEB"><enum>(1)</enum><header>In general</header><text><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/100">Chapter 100</external-xref> of the Internal Revenue Code of 1986 is amended—</text><subparagraph commented="no" display-inline="no-display-inline" id="HF4BCAFD213CB4B4B8EC0F2847F7A5DAA"><enum>(A)</enum><text display-inline="yes-display-inline">by adding at the end of subchapter B the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HA4DF23DA1389448581FA3EA48844272A"><section id="H0DC8529B97FE44EFBF4C28402A587D5D"><enum>9826.</enum><header>Oversight of entities that provide pharmacy benefit management services</header><subsection id="HAF0055FDFD8B45F29071E3F92A8978E6"><enum>(a)</enum><header>In general</header><text>For plan years beginning on or after the date that is 30 months after the date of enactment of this section (referred to in this subsection and subsection (b) as the <quote>effective date</quote>), a group health plan, or an entity providing pharmacy benefit management services on behalf of such a plan, shall not enter into a contract, including an extension or renewal of a contract, entered into on or after the effective date, with an applicable entity unless such applicable entity agrees to—</text><paragraph id="HBCB6945A9C894C7CB48F50612D1BB8C2"><enum>(1)</enum><text>not limit or delay the disclosure of information to the group health plan in such a manner that prevents an entity providing pharmacy benefit management services on behalf of a group health plan from making the reports described in subsection (b); and</text></paragraph><paragraph id="H0DB5B4E98C444BE5BCCC75C6C2EB59E7"><enum>(2)</enum><text>provide the entity providing pharmacy benefit management services on behalf of a group health plan relevant information necessary to make the reports described in subsection (b).</text></paragraph></subsection><subsection id="HD8EB2B77EEA74D009179103469F13DA9"><enum>(b)</enum><header>Reports</header><paragraph id="H434A6423E088479697F37B8E9F2E08CF"><enum>(1)</enum><header>In general</header><text>For plan years beginning on or after the effective date, in the case of any contract between a group health plan and an entity providing pharmacy benefit management services on behalf of such plan, including an extension or renewal of such a contract, entered into on or after the effective date, the entity providing pharmacy benefit management services on behalf of such a group health plan, not less frequently than every 6 months (or, at the request of a group health plan, not less frequently than quarterly, and under the same conditions, terms, and cost of the semiannual report under this subsection), shall submit to the group health plan a report in accordance with this section. Each such report shall be made available to such group health plan in plain language, in a machine-readable format, and as the Secretary may determine, other formats. Each such report shall include the information described in paragraph (2).</text></paragraph><paragraph id="HA51798DB463C4BC0A9DAD1AAC1DED0A2"><enum>(2)</enum><header>Information described</header><text>For purposes of paragraph (1), the information described in this paragraph is, with respect to drugs covered by a group health plan during each reporting period—</text><subparagraph id="H74B78FF02E1041608F0AF90B828277A9"><enum>(A)</enum><text>in the case of a group health plan that is offered by a specified large employer or that is a specified large plan, and is not offered as health insurance coverage, or in the case of health insurance coverage for which the election under paragraph (3) is made for the applicable reporting period—</text><clause id="HE064AA888B4F4AA8A45E1858AF5736E6"><enum>(i)</enum><text>a list of drugs for which a claim was filed and, with respect to each such drug on such list—</text><subclause id="H152AED90E7394630A28FA8E13C75A92C"><enum>(I)</enum><text>the contracted compensation paid by the group health plan for each covered drug (identified by the National Drug Code) to the entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan;</text></subclause><subclause id="HB2FA3F6BCAA64774992B8ED7751B018B"><enum>(II)</enum><text>the contracted compensation paid to the pharmacy, by any entity providing pharmacy benefit management services or other applicable entity on behalf of the group health plan, for each covered drug (identified by the National Drug Code);</text></subclause><subclause id="HE8100393E27643E7B74DB94F53A0F597"><enum>(III)</enum><text>for each such claim, the difference between the amount paid under subclause (I) and the amount paid under subclause (II);</text></subclause><subclause id="HEE64CD709CB14CBCAAE7EC861CA6AB13"><enum>(IV)</enum><text>the proprietary name, established name or proper name, and National Drug Code;</text></subclause><subclause id="HCB608E629D2541EDB962DE31A4DA978B"><enum>(V)</enum><text>for each claim for the drug (including original prescriptions and refills) and for each dosage unit of the drug for which a claim was filed, the type of dispensing channel used to furnish the drug, including retail, mail order, or specialty pharmacy;</text></subclause><subclause id="HF50574DD783F4C1CB3FEBA84C59F5424"><enum>(VI)</enum><text>with respect to each drug dispensed, for each type of dispensing channel (including retail, mail order, or specialty pharmacy)—</text><item commented="no" display-inline="no-display-inline" id="H14632A7BEC21472EA464993FE828A82C"><enum>(aa)</enum><text display-inline="yes-display-inline">whether such drug is a brand name drug or a generic drug, and—</text><subitem id="HB9FBA2E482464AF6B88A43868151AE44"><enum>(AA)</enum><text>in the case of a brand name drug, the wholesale acquisition cost, listed as cost per days supply and cost per dosage unit, on the date such drug was dispensed; and</text></subitem><subitem id="HAFBBC0D70A6645B39EEE172A444D4D76"><enum>(BB)</enum><text>in the case of a generic drug, the average wholesale price, listed as cost per days supply and cost per dosage unit, on the date such drug was dispensed; and</text></subitem></item><item id="H158885A21F36456693D344EAFD7440D3"><enum>(bb)</enum><text>the total number of—</text><subitem id="HDC3793DC52C44E2C8BEBF2478DA79FB0"><enum>(AA)</enum><text>prescription claims (including original prescriptions and refills);</text></subitem><subitem id="HD312C17C487D4E9EA06019EAF5AFF616"><enum>(BB)</enum><text>participants and beneficiaries for whom a claim for such drug was filed through the applicable dispensing channel;</text></subitem><subitem id="HE15A8DA16A6C41D29B06DA49C6FB6A72"><enum>(CC)</enum><text>dosage units and dosage units per fill of such drug; and</text></subitem><subitem id="H058F32CCA05B4731B0719A26D9B1D27A"><enum>(DD)</enum><text>days supply of such drug per fill;</text></subitem></item></subclause><subclause id="HA233FD3E19F7480193FCEF858256EE7F"><enum>(VII)</enum><text>the net price per course of treatment or single fill, such as a 30-day supply or 90-day supply to the plan after rebates, fees, alternative discounts, or other remuneration received from applicable entities;</text></subclause><subclause id="HD9B4722552C545239854AC5B23DF5BB0"><enum>(VIII)</enum><text>the total amount of out-of-pocket spending by participants and beneficiaries on such drug, including spending through copayments, coinsurance, and deductibles, but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan, or for which no claim is submitted under the plan;</text></subclause><subclause commented="no" id="HD04B39E9E7994710AAC28888F6F618A4"><enum>(IX)</enum><text>the total net spending on the drug;</text></subclause><subclause id="H24CF12F46D6A45F2880F53F367BE66AA"><enum>(X)</enum><text>the total amount received, or expected to be received, by the plan from any applicable entity in rebates, fees, alternative discounts, or other remuneration;</text></subclause><subclause id="H3C9470B4DB274538AFDDCE5AF75A5FD5"><enum>(XI)</enum><text>the total amount received, or expected to be received, by the entity providing pharmacy benefit management services, from applicable entities, in rebates, fees, alternative discounts, or other remuneration from such entities— </text><item commented="no" display-inline="no-display-inline" id="HCE01E5FB686448C28CD17291559D9213"><enum>(aa)</enum><text display-inline="yes-display-inline">for claims incurred during the reporting period; and</text></item><item commented="no" display-inline="no-display-inline" id="HEB594513439A437C840600B7212B70F3"><enum>(bb)</enum><text display-inline="yes-display-inline">that is related to utilization of such drug or spending on such drug; and</text></item></subclause><subclause id="H23FA379F5EC242CA87AE585227834589"><enum>(XII)</enum><text>to the extent feasible, information on the total amount of remuneration for such drug, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copayment assistance on behalf of such drug manufacturer), to the participants and beneficiaries enrolled in such plan;</text></subclause></clause><clause id="H29690273C3E845899BFD52455100FADB"><enum>(ii)</enum><text>a list of each therapeutic class (as defined by the Secretary) for which a claim was filed under the group health plan during the reporting period, and, with respect to each such therapeutic class—</text><subclause id="H9A593C29C96C4DF88CCBE5C9363AE847"><enum>(I)</enum><text>the total gross spending on drugs in such class before rebates, price concessions, alternative discounts, or other remuneration from applicable entities; </text></subclause><subclause id="HFBF94F09103A4ECC94CA02A19DAAC6D0"><enum>(II)</enum><text>the net spending in such class after such rebates, price concessions, alternative discounts, or other remuneration from applicable entities; </text></subclause><subclause id="H72FADCE46A78461BB4953624E91BB63E"><enum>(III)</enum><text>the total amount received, or expected to be received, by the entity providing pharmacy benefit management services, from applicable entities, in rebates, fees, alternative discounts, or other remuneration from such entities— </text><item commented="no" display-inline="no-display-inline" id="HFBE6831F8DF24008B0AC30FD34068401"><enum>(aa)</enum><text display-inline="yes-display-inline">for claims incurred during the reporting period; and</text></item><item commented="no" display-inline="no-display-inline" id="H0FF3F477C7A04A69AEF805DA5323730F"><enum>(bb)</enum><text display-inline="yes-display-inline">that is related to utilization of drugs or drug spending;</text></item></subclause><subclause id="HBF05BEA1C04D45088B47E438BAD331DD"><enum>(IV)</enum><text>the average net spending per 30-day supply and per 90-day supply by the plan and its participants and beneficiaries, among all drugs within the therapeutic class for which a claim was filed during the reporting period;</text></subclause><subclause id="H4CE0F96178F4422B80F2331D3B9F0FAE"><enum>(V)</enum><text>the number of participants and beneficiaries who filled a prescription for a drug in such class, including the National Drug Code for each such drug;</text></subclause><subclause id="H6F99FA0BEC324BEAA60A4047C5987CC9"><enum>(VI)</enum><text>if applicable, a description of the formulary tiers and utilization mechanisms (such as prior authorization or step therapy) employed for drugs in that class; and</text></subclause><subclause id="H39BCB0663FC34BF1912B65949B1F0CB7"><enum>(VII)</enum><text>the total out-of-pocket spending under the plan by participants and beneficiaries, including spending through copayments, coinsurance, and deductibles, but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or for which no claim is submitted under the plan;</text></subclause></clause><clause id="H21A5770838C447F28BC3564071CE67DA"><enum>(iii)</enum><text>with respect to any drug for which gross spending under the group health plan exceeded $10,000 during the reporting period or, in the case that gross spending under the group health plan exceeded $10,000 during the reporting period with respect to fewer than 50 drugs, with respect to the 50 prescription drugs with the highest spending during the reporting period—</text><subclause commented="no" display-inline="no-display-inline" id="HA4A7505EAC1D408BBF15EB692FA0B1B1"><enum>(I)</enum><text display-inline="yes-display-inline">a list of all other drugs in the same therapeutic class as such drug; </text></subclause><subclause commented="no" display-inline="no-display-inline" id="HC1E7C1FCA2DB4BF48C78E4B72D2E1F54"><enum>(II)</enum><text display-inline="yes-display-inline">if applicable, the rationale for the formulary placement of such drug in that therapeutic category or class, selected from a list of standard rationales established by the Secretary, in consultation with stakeholders; and </text></subclause><subclause commented="no" display-inline="no-display-inline" id="HBE73A3F82B4E4C558500D731E8CB6E46"><enum>(III)</enum><text display-inline="yes-display-inline">any change in formulary placement compared to the prior plan year; and</text></subclause></clause><clause id="H2ECCEBEF2E0A4297BCA56F62A88050E9"><enum>(iv)</enum><text>in the case that such plan (or an entity providing pharmacy benefit management services on behalf of such plan) has an affiliated pharmacy or pharmacy under common ownership, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost sharing assistance incentives funded by an entity providing pharmacy benefit services—</text><subclause id="HF5A881A4300D44B8A1E56794C6CCCEFF"><enum>(I)</enum><text>an explanation of any benefit design parameters that encourage or require participants and beneficiaries in the plan to fill prescriptions at mail order, specialty, or retail pharmacies;</text></subclause><subclause id="HA94B00B5436D47149918BA158DEF9424"><enum>(II)</enum><text>the percentage of total prescriptions dispensed by such pharmacies to participants or beneficiaries in such plan; and</text></subclause><subclause id="H4CA3BCFC66914FF6AC237E14CF02C029"><enum>(III)</enum><text>a list of all drugs dispensed by such pharmacies to participants or beneficiaries enrolled in such plan, and, with respect to each drug dispensed—</text><item id="H6B94E4A925C945CFA14580D766160966"><enum>(aa)</enum><text>the amount charged, per dosage unit, per 30-day supply, or per 90-day supply (as applicable) to the plan, and to participants and beneficiaries;</text></item><item id="HEC599F9447344B4EBDB70899B45E98CD"><enum>(bb)</enum><text>the median amount charged to such plan, and the interquartile range of the costs, per dosage unit, per 30-day supply, and per 90-day supply, including amounts paid by the participants and beneficiaries, when the same drug is dispensed by other pharmacies that are not affiliated with or under common ownership with the entity and that are included in the pharmacy network of such plan;</text></item><item id="H0554E83917F845DA9117F33A1CC168D7"><enum>(cc)</enum><text>the lowest cost per dosage unit, per 30-day supply and per 90-day supply, for each such drug, including amounts charged to the plan and to participants and beneficiaries, that is available from any pharmacy included in the network of such plan; and</text></item><item id="HBB7A9169B83149CBB4FA61211E31BD9F"><enum>(dd)</enum><text>the net acquisition cost per dosage unit, per 30-day supply, and per 90-day supply, if such drug is subject to a maximum price discount; and</text></item></subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="HF9342E3CCE3A48B8A8FFC381A8DB18E2"><enum>(B)</enum><text>with respect to any group health plan, regardless of whether the plan is offered by a specified large employer or whether it is a specified large plan—</text><clause commented="no" display-inline="no-display-inline" id="H2167F77C4AC4495E8E65237D791A2856"><enum>(i)</enum><text display-inline="yes-display-inline">a summary document for the group health plan that includes such information described in clauses (i) through (iv) of subparagraph (A), as specified by the Secretary through guidance, program instruction, or otherwise (with no requirement of notice and comment rulemaking), that the Secretary determines useful to group health plans for purposes of selecting pharmacy benefit management services, such as an estimated net price to group health plan and participant or beneficiary, a cost per claim, the fee structure or reimbursement model, and estimated cost per participant or beneficiary; </text></clause><clause commented="no" display-inline="no-display-inline" id="HC75CF7C2CBEB49BBA24A2E326E5D5D6E"><enum>(ii)</enum><text display-inline="yes-display-inline">a summary document for plans to provide to participants and beneficiaries, which shall be made available to participants or beneficiaries upon request to their group health plan, that—</text><subclause commented="no" display-inline="no-display-inline" id="H309242290C6D4F6EBD563B9C5AF8614F"><enum>(I)</enum><text display-inline="yes-display-inline">contains such information described in clauses (iii), (iv), (v), and (vi), as applicable, as specified by the Secretary through guidance, program instruction, or otherwise (with no requirement of notice and comment rulemaking) that the Secretary determines useful to participants or beneficiaries in better understanding the plan or benefits under such plan;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HC486B48610F54581A7802B280E80FB3E"><enum>(II)</enum><text display-inline="yes-display-inline">contains only aggregate information; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HA04A2DA490C74559A583B427E529AE0F"><enum>(III)</enum><text display-inline="yes-display-inline">states that participants and beneficiaries may request specific, claims-level information required to be furnished under subsection (c) from the group health plan; and</text></subclause></clause><clause id="HC0D4A314B8474A16AC24C1445FC9D563"><enum>(iii)</enum><text>with respect to drugs covered by such plan during such reporting period—</text><subclause id="H7CC008C3D5D14DC2A1B5A5BA55138EFB"><enum>(I)</enum><text>the total net spending by the plan for all such drugs;</text></subclause><subclause id="HD085A51A0E3F4D69A42788571ADC5C3B"><enum>(II)</enum><text>the total amount received, or expected to be received, by the plan from any applicable entity in rebates, fees, alternative discounts, or other remuneration; and</text></subclause><subclause id="H4B5D7A62AF214A3EBBF97714AF7CEE3E"><enum>(III)</enum><text>to the extent feasible, information on the total amount of remuneration for such drugs, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copayment assistance on behalf of such drug manufacturer) to participants and beneficiaries;</text></subclause></clause><clause id="H5B7DFB931C5F4A84A6001657F45E937C"><enum>(iv)</enum><text>amounts paid directly or indirectly in rebates, fees, or any other type of compensation (as defined in section 408(b)(2)(B)(ii)(dd)(AA) of the Employee Retirement Income Security Act (29 U.S.C. 1108(b)(2)(B)(ii)(dd)(AA))) to brokerage firms, brokers, consultants, advisors, or any other individual or firm, for—</text><subclause id="HEA5330463C404E17AB2514F46707537D"><enum>(I)</enum><text>the referral of the group health plan's business to an entity providing pharmacy benefit management services, including the identity of the recipient of such amounts;</text></subclause><subclause id="H29862DD5F64C445AA27EB8FC1011DB8C"><enum>(II)</enum><text>consideration of the entity providing pharmacy benefit management services by the group health plan; or</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H90936299F47F4E8C8E7391E6CCC6253B"><enum>(III)</enum><text display-inline="yes-display-inline">the retention of the entity by the group health plan;</text></subclause></clause><clause id="HB44A64A527034A379BC8C0A7AED1A2BF"><enum>(v)</enum><text>an explanation of any benefit design parameters that encourage or require participants and beneficiaries in such plan to fill prescriptions at mail order, specialty, or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services under such plan, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost-sharing assistance incentives directly or indirectly funded by such entity; and</text></clause><clause id="H2DB3328A4FC14DA3A77391FDB5A06744"><enum>(vi)</enum><text>total gross spending on all drugs under the plan during the reporting period.</text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H43F2B07D2A6347819B48B2C6A016CC17"><enum>(3)</enum><header>Opt-in for group health insurance coverage offered by a specified large employer or that is a specified large plan</header><text>In the case of group health insurance coverage offered in connection with a group health plan that is offered by a specified large employer or is a specified large plan, such group health plan may, on an annual basis, for plan years beginning on or after the date that is 30 months after the date of enactment of this section, elect to require an entity providing pharmacy benefit management services on behalf of the health insurance issuer to submit to such group health plan a report that includes all of the information described in paragraph (2)(A), in addition to the information described in paragraph (2)(B). </text></paragraph><paragraph id="H1B252A6848404F1BAD2AF78D2465CB62"><enum>(4)</enum><header>Privacy requirements</header><subparagraph id="H9CF3F99F47F44733B0A249299004F78F"><enum>(A)</enum><header>In general</header><text>An entity providing pharmacy benefit management services on behalf of a group health plan shall report information under paragraph (1) in a manner consistent with the privacy regulations promulgated under section 13402(a) of the Health Information Technology for Economic and Clinical Health Act (<external-xref legal-doc="usc" parsable-cite="usc/42/17932">42 U.S.C. 17932(a)</external-xref>) and consistent with the privacy regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 in part 160 and subparts A and E of part 164 of title 45, Code of Federal Regulations (or successor regulations) (referred to in this paragraph as the <quote>HIPAA privacy regulations</quote>) and shall restrict the use and disclosure of such information according to such privacy regulations and such HIPAA privacy regulations. </text></subparagraph><subparagraph id="HB9BC18FCFE4B46B4B2F559C077DDAE0F"><enum>(B)</enum><header>Additional requirements</header><clause id="HD77D373C8CE54FEABC2C15E451A11074"><enum>(i)</enum><header>In general</header><text>An entity providing pharmacy benefit management services on behalf of a group health plan that submits a report under paragraph (1) shall ensure that such report contains only summary health information, as defined in section 164.504(a) of title 45, Code of Federal Regulations (or successor regulations).</text></clause><clause id="HCF4C3856A7A747D58E843EB2D3771C54"><enum>(ii)</enum><header>Restrictions</header><text>In carrying out this subsection, a group health plan shall comply with section 164.504(f) of title 45, Code of Federal Regulations (or a successor regulation), and a plan sponsor shall act in accordance with the terms of the agreement described in such section.</text></clause></subparagraph><subparagraph id="HCCB59CFAAEC94789A80C1288BBBEAAF5"><enum>(C)</enum><header>Rule of construction</header><clause commented="no" display-inline="no-display-inline" id="H46AB9AD7E7F64BC4AFFDC6C453129E9E"><enum>(i)</enum><text display-inline="yes-display-inline">Nothing in this section shall be construed to modify the requirements for the creation, receipt, maintenance, or transmission of protected health information under the HIPAA privacy regulations. </text></clause><clause commented="no" display-inline="no-display-inline" id="HF32F5438CF9A4CCABDCD7306ACAF494B"><enum>(ii)</enum><text display-inline="yes-display-inline">Nothing in this section shall be construed to affect the application of any Federal or State privacy or civil rights law, including the HIPAA privacy regulations, the Genetic Information Nondiscrimination Act of 2008 (<external-xref legal-doc="public-law" parsable-cite="pl/110/233">Public Law 110–233</external-xref>) (including the amendments made by such Act), the Americans with Disabilities Act of 1990 (<external-xref legal-doc="usc" parsable-cite="usc/42/12101">42 U.S.C. 12101 et seq.</external-xref>), section 504 of the Rehabilitation Act of 1973 (<external-xref legal-doc="usc" parsable-cite="usc/29/794">29 U.S.C. 794</external-xref>), section 1557 of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18116">42 U.S.C. 18116</external-xref>), title VI of the Civil Rights Act of 1964 (<external-xref legal-doc="usc" parsable-cite="usc/42/2000d">42 U.S.C. 2000d</external-xref>), and title VII of the Civil Rights Act of 1964 (<external-xref legal-doc="usc" parsable-cite="usc/42/2000e">42 U.S.C. 2000e</external-xref>). </text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H93F6CD9AD14F4AF0A056556F105FC9CC"><enum>(D)</enum><header>Written notice</header><text display-inline="yes-display-inline">Each plan year, group health plans shall provide to each participant or beneficiary written notice informing the participant or beneficiary of the requirement for entities providing pharmacy benefit management services on behalf of the group health plan to submit reports to group health plans under paragraph (1), as applicable, which may include incorporating such notification in plan documents provided to the participant or beneficiary, or providing individual notification. </text></subparagraph><subparagraph commented="no" id="H23818535C2154088A331D5A0243E829B"><enum>(E)</enum><header>Limitation to business associates</header><text>A group health plan receiving a report under paragraph (1) may disclose such information only to the entity from which the report was received or to that entity’s business associates as defined in section 160.103 of title 45, Code of Federal Regulations (or successor regulations) or as permitted by the HIPAA privacy regulations.</text></subparagraph><subparagraph id="H48B36BC12EF7428A9E4565A236FCD70C"><enum>(F)</enum><header>Clarification regarding public disclosure of information</header><text>Nothing in this section shall prevent an entity providing pharmacy benefit management services on behalf of a group health plan, from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph (1), except that such plan or entity may not—</text><clause commented="no" display-inline="no-display-inline" id="HD0B208B81EBC4B9B8EDEC60B46FE0C53"><enum>(i)</enum><text display-inline="yes-display-inline">restrict disclosure of such report to the Department of Health and Human Services, the Department of Labor, or the Department of the Treasury; or</text></clause><clause commented="no" display-inline="no-display-inline" id="H7C794664845C4A5FA797FC0898071F68"><enum>(ii)</enum><text>prevent disclosure for the purposes of subsection (c), or any other public disclosure requirement under this section.</text></clause></subparagraph><subparagraph id="HF2F92D7FE0E842A4B468104AA77112C2"><enum>(G)</enum><header>Limited form of report</header><text>The Secretary shall define through rulemaking a limited form of the report under paragraph (1) required with respect to any group health plan established by a plan sponsor that is, or is affiliated with, a drug manufacturer, drug wholesaler, or other direct participant in the drug supply chain, in order to prevent anti-competitive behavior.</text></subparagraph></paragraph><paragraph id="H26B963AD69554AB19142A6AAAB68D4B9"><enum>(5)</enum><header>Standard format and regulations</header><subparagraph id="HA594BDFDDB4A4F49A262261A753A8B12"><enum>(A)</enum><header>In general</header><text>Not later than 18 months after the date of enactment of this section, the Secretary shall specify through rulemaking a standard format for entities providing pharmacy benefit management services on behalf of group health plans, to submit reports required under paragraph (1).</text></subparagraph><subparagraph id="H3632044F887C4D47B230A061404DC14F"><enum>(B)</enum><header>Additional regulations</header><text>Not later than 18 months after the date of enactment of this section, the Secretary shall, through rulemaking, promulgate any other final regulations necessary to implement the requirements of this section. In promulgating such regulations, the Secretary shall, to the extent practicable, align the reporting requirements under this section with the reporting requirements under section 9825.</text></subparagraph></paragraph></subsection><subsection id="H09AA5E1C45CF4DF3947364DE7CA23C85"><enum>(c)</enum><header>Requirement To provide information to participants or beneficiaries</header><text>A group health plan, upon request of a participant or beneficiary, shall provide to such participant or beneficiary—</text><paragraph commented="no" display-inline="no-display-inline" id="HA7E005295C2D491082912B2D36608CBD"><enum>(1)</enum><text display-inline="yes-display-inline">the summary document described in subsection (b)(2)(B)(ii); and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H4BF4944EA8764FDF8B4162D30B20915B"><enum>(2)</enum><text display-inline="yes-display-inline">the information described in subsection (b)(2)(A)(i)(III) with respect to a claim made by or on behalf of such participant or beneficiary. </text></paragraph></subsection><subsection id="HB0DDEF30B9B3457F839142206D447943"><enum>(d)</enum><header>Rule of construction</header><text>Nothing in this section shall be construed to permit a health insurance issuer, group health plan, entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer, or other entity to restrict disclosure to, or otherwise limit the access of, the Secretary to a report described in subsection (b)(1) or information related to compliance with subsections (a), (b), or (c) of this section or section 4980D(g) by such issuer, plan, or entity. </text></subsection><subsection commented="no" id="HE2A613402DE940E7AE3A767F0ED70FF1"><enum>(e)</enum><header>Definitions</header><text>In this section:</text><paragraph commented="no" id="HB18838ABFC5141B68174C40F24BAF06E"><enum>(1)</enum><header>Applicable entity</header><text>The term <term>applicable entity</term> means—</text><subparagraph commented="no" id="H0C1C195A0F16490390BE945DF1674972"><enum>(A)</enum><text>an applicable group purchasing organization, drug manufacturer, distributor, wholesaler, rebate aggregator (or other purchasing entity designed to aggregate rebates), or associated third party;</text></subparagraph><subparagraph commented="no" id="H2272D5E0347042B69E7C33F858D19359"><enum>(B)</enum><text>any subsidiary, parent, affiliate, or subcontractor of a group health plan, health insurance issuer, entity that provides pharmacy benefit management services on behalf of such a plan or issuer, or any entity described in subparagraph (A); or</text></subparagraph><subparagraph commented="no" id="H17EBC0EB8BCB47F68A2EC4C79013E819"><enum>(C)</enum><text>such other entity as the Secretary may specify through rulemaking.</text></subparagraph></paragraph><paragraph commented="no" id="H3C4CD6DA3AF84615862A9AE03392A5ED"><enum>(2)</enum><header>Applicable group purchasing organization</header><text>The term <term>applicable group purchasing organization</term> means a group purchasing organization that is affiliated with or under common ownership with an entity providing pharmacy benefit management services.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H12D2DFE5EA3A4E4EA6336D626044EEEB"><enum>(3)</enum><header display-inline="yes-display-inline">Contracted compensation</header><text display-inline="yes-display-inline">The term <term>contracted compensation</term> means the sum of any ingredient cost and dispensing fee for a drug (inclusive of the out-of-pocket costs to the participant or beneficiary), or another analogous compensation structure that the Secretary may specify through regulations. </text></paragraph><paragraph commented="no" id="H26F9F98FA9AE495193945D32F3507DCA"><enum>(4)</enum><header>Gross spending</header><text>The term <term>gross spending</term>, with respect to prescription drug benefits under a group health plan, means the amount spent by a group health plan on prescription drug benefits, calculated before the application of rebates, fees, alternative discounts, or other remuneration.</text></paragraph><paragraph commented="no" id="HB25395D7070549618271818AC1FBA873"><enum>(5)</enum><header>Net spending</header><text>The term <term>net spending</term>, with respect to prescription drug benefits under a group health plan, means the amount spent by a group health plan on prescription drug benefits, calculated after the application of rebates, fees, alternative discounts, or other remuneration.</text></paragraph><paragraph commented="no" id="H32014124B80F4B219885FC891BA2D045"><enum>(6)</enum><header>Plan sponsor</header><text>The term <term>plan sponsor</term> has the meaning given such term in section 3(16)(B) of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1002">29 U.S.C. 1002(16)(B)</external-xref>).</text></paragraph><paragraph commented="no" id="HCA91E6B329EA46A6897C38AB0C195B94"><enum>(7)</enum><header>Remuneration</header><text>The term <term>remuneration</term> has the meaning given such term by the Secretary, through rulemaking, which shall be reevaluated by the Secretary every 5 years.</text></paragraph><paragraph commented="no" id="HCDF42265C54E4D22A62777DF6CC940F5"><enum>(8)</enum><header>Specified large employer</header><text>The term <term>specified large employer</term> means, in connection with a group health plan established or maintained by a single employer, with respect to a calendar year or a plan year, as applicable, an employer who employed an average of at least 100 employees on business days during the preceding calendar year or plan year and who employs at least 1 employee on the first day of the calendar year or plan year. </text></paragraph><paragraph commented="no" id="H82AE1054ACDA4F0E96322BF75D04A145"><enum>(9)</enum><header>Specified large plan</header><text>The term <term>specified large plan</term> means a group health plan established or maintained by a plan sponsor described in clause (ii) or (iii) of section 3(16)(B) of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1002">29 U.S.C. 1002(16)(B)</external-xref>) that had an average of at least 100 participants on business days during the preceding calendar year or plan year, as applicable. </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H0DFC09BAD4AA4239B1A8D63B74B4904C"><enum>(10)</enum><header display-inline="yes-display-inline">Wholesale acquisition cost</header><text>The term <term>wholesale acquisition cost</term> has the meaning given such term in section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)(B)).</text></paragraph></subsection></section><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF39799E5DBC046808DB8AE8235C1EFE4"><enum>(2)</enum><header>Exception for certain group health plans</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/9831">Section 9831(a)(2)</external-xref> of the Internal Revenue Code of 1986 is amended by inserting <quote>other than with respect to section 9826,</quote> before <quote>any group health plan</quote>. </text></paragraph><paragraph id="HB4C46EE7CFF64D13ABD8CCA490962D6B"><enum>(3)</enum><header>Enforcement</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/4980D">Section 4980D</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new subsection:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H834CA55A42AE47FAA8090035261C5012"><subsection id="H743F529D2AE847539F9BEEC2298F0A50"><enum>(g)</enum><header>Application to requirements imposed on certain entities providing pharmacy benefit management services</header><text display-inline="yes-display-inline">In the case of any requirement under section 9826 that applies with respect to an entity providing pharmacy benefit management services on behalf of a group health plan, any reference in this section to such group health plan (and the reference in subsection (e)(1) to the employer) shall be treated as including a reference to such entity.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="HB6820975E57641A6B4A39B186FB4928E"><enum>(4)</enum><header>Clerical amendment</header><text>The table of sections for subchapter B of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/100">chapter 100</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new item:</text><toc><toc-entry bold="off" level="section"><quote>Sec. 9826. Oversight of entities that provide pharmacy benefit management services.</quote>.</toc-entry></toc></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="H7C7A2EB5182A410CA55B2746CDBC50E7"><enum>902.</enum><header>Full rebate pass through to plan; exception for innocent plan fiduciaries</header><subsection commented="no" display-inline="no-display-inline" id="HF6F770C5CA214F9A916E0185F1049FE2"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 408(b)(2) of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1108">29 U.S.C. 1108(b)(2)</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H6A0AEFC216924B4785CEC8E2AF92F422"><enum>(1)</enum><text display-inline="yes-display-inline">in subparagraph (B)(viii)—</text><subparagraph commented="no" display-inline="no-display-inline" id="H92C2F0F1C8A74CAA89B10D12F797DA50"><enum>(A)</enum><text>by redesignating subclauses (II) through (IV) as subclauses (III) through (V), respectively;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H831C4B3DA805456AA3C68B96C9B6C398"><enum>(B)</enum><text>in subclause (I)—</text><clause commented="no" display-inline="no-display-inline" id="H58761F608EDB449A9D60124D92B5A4EC"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>subclause (II)</quote> and inserting <quote>subclause (III)</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="HE24BD4F671E24A08AEC63EAD2240E257"><enum>(ii)</enum><text>by striking <quote>subclauses (II) and (III)</quote> and inserting <quote>subclauses (III) and (IV)</quote>; and</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H07DDDA6BA26D427DB0880E3C21FBB490"><enum>(C)</enum><text display-inline="yes-display-inline">by inserting after subclause (I) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H26BE80B6234540E581035477DCCD77D9"><subclause id="H685C59C1751E462F8158909A57BCD70E" indent="up3"><enum>(II)</enum><text>Pursuant to subsection (a), subparagraphs (C) and (D) of section 406(a)(1) shall not apply to a responsible plan fiduciary, notwithstanding any failure to remit required amounts under subparagraph (C)(i), if the following conditions are met:</text><item commented="no" display-inline="no-display-inline" id="H08FE0C3429FA4A719B8F0203BF2FE623"><enum>(aa)</enum><text display-inline="yes-display-inline">The responsible plan fiduciary did not know that the covered service provider failed or would fail to make required remittances and reasonably believed that the covered service provider remitted such required amounts.</text></item><item commented="no" display-inline="no-display-inline" id="H9BA0495D70694192B245FF49CB0C84EC"><enum>(bb)</enum><text display-inline="yes-display-inline">The responsible plan fiduciary, upon discovering that the covered service provider failed to remit the required amounts, requests in writing that the covered service provider remit such amounts. </text></item><item commented="no" display-inline="no-display-inline" id="HC49376F5195549E98BAA5C3212364518"><enum>(cc)</enum><text display-inline="yes-display-inline">If the covered service provider fails to comply with a written request described in subclause (III) within 90 days of the request, the responsible plan fiduciary notifies the Secretary of the covered service provider’s failure, in accordance with subclauses (III) and (IV).</text></item></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="H07F0656B60EA471BA73A703A844ABE76"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H6B570F05B6934DDAA841DB37D42DB18B"><subparagraph id="H207C18225AFC480F90E36BFCE443C1EA" indent="up1"><enum>(C)</enum><clause commented="no" display-inline="yes-display-inline" id="H2F68C50DA7A84A2EAE81CE13A4C79666"><enum>(i)</enum><subclause commented="no" display-inline="yes-display-inline" id="HC526B716A6DA4AFEAEB723FEFDBEC238"><enum>(I)</enum><text>For plan years beginning on or after the date that is 30 months after the date of enactment of this subparagraph (referred to in this clause as the <quote>effective date</quote>), no contract or arrangement or renewal or extension of a contract or arrangement, entered into on or after the effective date, for services between a covered plan and a covered service provider, through a health insurance issuer offering group health insurance coverage, a third party administrator, an entity providing pharmacy benefit management services, or other entity, for pharmacy benefit management services, is reasonable within the meaning of this paragraph unless such entity providing pharmacy benefit management services— </text><item indent="up2" commented="no" display-inline="no-display-inline" id="H7D667872B4D5435A9344E57EAD37FB40"><enum>(aa)</enum><text display-inline="yes-display-inline">remits 100 percent of rebates, fees, alternative discounts, and other remuneration received from any applicable entity that are related to utilization of drugs or drug spending under such health plan or health insurance coverage, to the group health plan or health insurance issuer offering group health insurance coverage; and</text></item><item indent="up2" commented="no" display-inline="no-display-inline" id="HA689145FAEA54B728F5EF232B53A1303"><enum>(bb)</enum><text display-inline="yes-display-inline">does not enter into any contract for pharmacy benefit management services on behalf of such a plan or coverage, with an applicable entity unless 100 percent of rebates, fees, alternative discounts, and other remuneration received under such contract that are related to the utilization of drugs or drug spending under such group health plan or health insurance coverage are remitted to the group health plan or health insurance issuer by the entity providing pharmacy benefit management services.</text></item></subclause><subclause id="H54466AB0236A4A6C9B361DB644D7F957" indent="up2"><enum>(II)</enum><text>Nothing in subclause (I) shall be construed to affect the term of a contract or arrangement, as in effect on the effective date (as described in such subclause), except that such subclause shall apply to any renewal or extension of such a contract or arrangement entered into on or after such effective date, as so described.</text></subclause></clause><clause indent="up1" commented="no" display-inline="no-display-inline" id="H1F78D664598F4BCB96A9F415B6EB0E18"><enum>(ii)</enum><text display-inline="yes-display-inline">With respect to such rebates, fees, alternative discounts, and other remuneration—</text><subclause commented="no" display-inline="no-display-inline" id="H18163463205644AB95011A96241D08A9"><enum>(I)</enum><text display-inline="yes-display-inline">the rebates, fees, alternative discounts, and other remuneration under clause (i)(I) shall be—</text><item commented="no" display-inline="no-display-inline" id="H12A5198E8E334CDB8FE37C121BF492B8"><enum>(aa)</enum><text display-inline="yes-display-inline">remitted—</text><subitem commented="no" display-inline="no-display-inline" id="HA4E684D97EEC4E389889225C7D44F914"><enum>(AA)</enum><text display-inline="yes-display-inline">on a quarterly basis, to the group health plan or the group health insurance issuer, not later than 90 days after the end of each quarter; or</text></subitem><subitem commented="no" display-inline="no-display-inline" id="H8F490087E29B4DD2B8D1441D9B44D3B8"><enum>(BB)</enum><text display-inline="yes-display-inline">in the case of an underpayment in a remittance for a prior quarter, as soon as practicable, but not later than 90 days after notice of the underpayment is first given;</text></subitem></item><item commented="no" display-inline="no-display-inline" id="HF910B7781F494FE2A0CEEA308D2F6B5B"><enum>(bb)</enum><text display-inline="yes-display-inline">fully disclosed and enumerated to the group health plan or health insurance issuer; and</text></item><item commented="no" display-inline="no-display-inline" id="H8FBC2F43B7A54F37A42C0F3A6CF2FE22"><enum>(cc)</enum><text display-inline="yes-display-inline">returned to the covered service provider for pharmacy benefit management services on behalf of the group health plan if any audit by a plan sponsor, issuer or a third party designated by a plan sponsor, indicates that the amounts received are incorrect after such amounts have been paid to the group health plan or health insurance issuer;</text></item></subclause><subclause commented="no" display-inline="no-display-inline" id="H952867178C4A4B8CA45E9665E55DDF1C"><enum>(II)</enum><text display-inline="yes-display-inline">the Secretary may establish procedures for the remittance of rebates fees, alternative discounts, and other remuneration under subclause (I)(aa) and the disclosure of rebates, fees, alternative discounts, and other remuneration under subclause (I)(bb); and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H79ED8537F3D44221996E45747DCCDB00"><enum>(III)</enum><text display-inline="yes-display-inline">the records of such rebates, fees, alternative discounts, and other remuneration shall be available for audit by the plan sponsor, issuer, or a third party designated by a plan sponsor, not less than once per plan year.</text></subclause></clause><clause indent="up1" commented="no" display-inline="no-display-inline" id="H53B31E021FEC41F2976A6B184881AF37"><enum>(iii)</enum><text display-inline="yes-display-inline">To ensure that an entity providing pharmacy benefit management services is able to meet the requirements of clause (ii)(I), a rebate aggregator (or other purchasing entity designed to aggregate rebates) and an applicable group purchasing organization shall remit such rebates to the entity providing pharmacy benefit management services not later than 45 days after the end of each quarter. </text></clause><clause indent="up1" commented="no" display-inline="no-display-inline" id="HE1466F234B56485BB9E73DD7D6244AE9"><enum>(iv)</enum><text display-inline="yes-display-inline">A third-party administrator of a group health plan, a health insurance issuer offering group health insurance coverage, or a covered service provider for pharmacy benefit management services under such health plan or health insurance coverage shall make rebate contracts with rebate aggregators or drug manufacturers available for audit by such plan sponsor or designated third party, subject to reasonable restrictions (as determined by the Secretary) on confidentiality to prevent re-disclosure of such contracts or use of such information in audits for purposes unrelated to this section.</text></clause><clause indent="up1" commented="no" display-inline="no-display-inline" id="H8268EBFB279F488BBC4371C121202A7E"><enum>(v)</enum><text display-inline="yes-display-inline">Audits carried out under clauses (ii)(III) and (iv) shall be performed by an auditor selected by the responsible plan fiduciary. Payment for such audits shall not be made, whether directly or indirectly, by the entity providing pharmacy benefit management services. </text></clause><clause indent="up1" commented="no" display-inline="no-display-inline" id="H23EAA54A2A234970AC90909D4210FFB2"><enum>(vi)</enum><text display-inline="yes-display-inline">Nothing in this subparagraph shall be construed to—</text><subclause commented="no" display-inline="no-display-inline" id="HBBC9F9DD64AE496DB60A6C73F1E6F877"><enum>(I)</enum><text display-inline="yes-display-inline">prohibit reasonable payments to entities offering pharmacy benefit management services for bona fide services using a fee structure not described in this subparagraph, provided that such fees are transparent and quantifiable to group health plans and health insurance issuers;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H44AF0FD1120148D4B4130BE1E52E4B02"><enum>(II)</enum><text display-inline="yes-display-inline">require a third-party administrator of a group health plan or covered service provider for pharmacy benefit management services under such health plan or health insurance coverage to remit bona fide service fees to the group health plan;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H322949E0290A4FFAABE1F5C052A5EA94"><enum>(III)</enum><text display-inline="yes-display-inline">limit the ability of a group health plan or health insurance issuer to pass through rebates, fees, alternative discounts, and other remuneration to the participant or beneficiary; or</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H3104DAFFAE0A44E1939502DF3E42EAA0"><enum>(IV)</enum><text display-inline="yes-display-inline">modify the requirements for the creation, receipt, maintenance, or transmission of protected health information under the privacy regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 in part 160 and subparts A and E of part 164 of title 45, Code of Federal Regulations (or successor regulations).</text></subclause></clause><clause commented="no" display-inline="no-display-inline" indent="up1" id="HC2AB857AA40B4CED8529DE59F7ABEF0E"><enum>(vii)</enum><text>For purposes of this subparagraph—</text><subclause commented="no" display-inline="no-display-inline" id="HD7C723FCD1194D73881130E1D07AD0BE"><enum>(I)</enum><text>the terms <term>applicable entity</term> and <term>applicable group purchasing organization</term> have the meanings given such terms in section 726(e);</text></subclause><subclause commented="no" display-inline="no-display-inline" id="HC3D05889E29D401793049154ACF0646D"><enum>(II)</enum><text>the terms <term>covered plan</term>, <term>covered service provider</term>, and <term>responsible plan fiduciary</term> have the meanings given such terms in subparagraph (B); and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="H893B6852C6D042E39420B9537543945F"><enum>(III)</enum><text>the terms <term>group health insurance coverage</term>, <term>health insurance coverage</term>, and <term>health insurance issuer</term> have the meanings given such terms in section 733.</text></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H33B1676FB929462C9171A71B13ADB33E"><enum>(b)</enum><header>Rule of construction</header><text display-inline="yes-display-inline">Subclause (II)(aa) of section 408(b)(2)(B)(viii) of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1108">29 U.S.C. 1108(b)(2)(B)(viii)</external-xref>), as amended by subsection (a), shall not be construed to relieve or limit a responsible plan fiduciary from the duty to monitor the practices of any covered service provider that contracts with the applicable covered plan, including for the purposes of ensuring the reasonableness of compensation. For purposes of this subsection, the terms <term>covered plan</term>, <term>covered service provider</term>, and <term>responsible plan fiduciary</term> have the meanings given such terms in section 408(b)(2)(B)(ii) of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1108">29 U.S.C. 1108(b)(2)(B)(ii)</external-xref>).</text></subsection><subsection id="HE7C120614727437983C0F52EA474444E"><enum>(c)</enum><header>Clarification of covered service provider</header><paragraph id="HF1B2E1E12D7645B7BF359C6E180DC23C"><enum>(1)</enum><header>Services</header><subparagraph commented="no" display-inline="no-display-inline" id="H1279A95FC6B64AEC819EE8A3F711D8E2"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Section 408(b)(2)(B)(ii)(I)(bb) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1108(b)(2)(B)(ii)(I)(bb)) is amended—</text><clause id="H239C7B8EA9494BB5AB31DEF907BC2A04"><enum>(i)</enum><text display-inline="yes-display-inline">in subitem (AA) by striking <quote>Brokerage services,</quote> and inserting <quote>Services (including brokerage services),</quote>; and</text></clause><clause id="H5D766CC43CF443AFB0A98E91400B3D14"><enum>(ii)</enum><text>in subitem (BB)—</text><subclause id="H3920E3D5517F4F1C8719500E894109D2"><enum>(I)</enum><text>by striking <quote>Consulting,</quote> and inserting <quote>Other services,</quote>; and</text></subclause><subclause id="H96D92F4C63C343CCB515B5DD91845BB8"><enum>(II)</enum><text>by striking <quote>related to the development or implementation of plan design</quote> and all that follows through the period at the end and inserting <quote>including any of the following: plan design, insurance or insurance product selection (including vision and dental), recordkeeping, medical management, benefits administration selection (including vision and dental), stop-loss insurance, pharmacy benefit management services, wellness design and management services, transparency tools, group purchasing organization agreements and services, participation in and services from preferred vendor panels, disease management, compliance services, employee assistance programs, or third party administration services, or consulting services related to any such services.</quote>.</text></subclause></clause></subparagraph><subparagraph id="HC950A89B122C470D8A5791449D9BA9E6"><enum>(B)</enum><header>Sense of Congress</header><text>It is the sense of Congress that the amendment made by subparagraph (A) clarifies the existing requirement of covered service providers with respect to services described in section 408(b)(2)(B)(ii)(I)(bb)(BB) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1108(b)(2)(B)(ii)(I)(bb)(BB)) that were in effect since the application date described in section 202(e) of the No Surprises Act (<external-xref legal-doc="public-law" parsable-cite="pl/116/260">Public Law 116–260</external-xref>; <external-xref legal-doc="usc" parsable-cite="usc/29/1108">29 U.S.C. 1108</external-xref> note), and does not impose any additional requirement under section 408(b)(2)(B) of such Act. </text></subparagraph></paragraph><paragraph id="H63BA41E4FBC54158A58EBBA97A066715"><enum>(2)</enum><header>Certain arrangements for pharmacy benefit management services considered as indirect</header><subparagraph id="H0B84C517DC4448C2921D4D94B6C1D684" commented="no"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Section 408(b)(2)(B)(i) of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1108">29 U.S.C. 1108(b)(2)(B)(i)</external-xref>) is amended—</text><clause id="H47B9FAF956B441F2B9713A5F5CCC843D" commented="no"><enum>(i)</enum><text>by striking <quote>requirements of this clause</quote> and inserting <quote>requirements of this subparagraph</quote>; and</text></clause><clause id="H3C19A8DB1BB245BFBFFDB7D6833E1D20"><enum>(ii)</enum><text>by adding at the end the following: <quote>For purposes of applying section 406(a)(1)(C) with respect to a transaction described under this subparagraph or subparagraph (C), a contract or arrangement for services between a covered plan and an entity providing services to the plan, including a health insurance issuer providing health insurance coverage in connection with the covered plan, in which such entity contracts, in connection with such plan, with a service provider for pharmacy benefit management services, shall be considered an indirect furnishing of goods, services, or facilities between the covered plan and the service provider for pharmacy benefit management services acting as the party in interest.</quote>.</text></clause></subparagraph><subparagraph id="H796114AE3EEF460AA71FE50304F62170"><enum>(B)</enum><header>Health insurance issuer and health insurance coverage defined</header><text display-inline="yes-display-inline">Section 408(b)(2)(B)(ii)(I)(aa) of such Act (29 U.S.C. 1108(b)(2)(B)(ii)(I)(aa)) is amended by inserting before the period at the end <quote>and the terms <term>health insurance coverage</term> and <term>health insurance issuer</term> have the meanings given such terms in section 733(b)</quote>. </text></subparagraph><subparagraph id="H0F0075451AEF452386EB8DC4B975BA04"><enum>(C)</enum><header>Technical amendment</header><text>Section 408(b)(2)(B)(ii)(I)(aa) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1108(b)(2)(B)(ii)(I)(aa)) is amended by inserting <quote>in</quote> after <quote>defined</quote>. </text></subparagraph></paragraph></subsection></section><section section-type="subsequent-section" id="H3B1D19808DFC4528BA3A8406523F4ECB" changed="not-changed"><enum>903.</enum><header>Increasing transparency in generic drug applications</header><subsection id="H2DCD03FC7AFC4426A5F20EA6C166245A" changed="not-changed"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 505(j)(3) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(j)(3)</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H75577154F3E6428C928EA0FFC064BF8B" changed="not-changed"><subparagraph id="H790291D52D1A431884A2B81FF5AED376" indent="up2" changed="not-changed"><enum>(H)</enum><clause commented="no" display-inline="yes-display-inline" id="HAF5183F3443742F8AFBF76AE58C5BBA5" changed="not-changed"><enum>(i)</enum><text>Upon request (in controlled correspondence or an analogous process) by a person that has submitted or intends to submit an abbreviated application under this subsection for a drug that is required by regulation to contain one or more of the same inactive ingredients in the same concentrations as the listed drug referred to, or for which the Secretary determines there is a scientific justification for an approach that is in vitro, in whole or in part, to be used to demonstrate bioequivalence for a drug if such a drug contains one or more of the same inactive ingredients in the same concentrations as the listed drug referred to, the Secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug. The Secretary may also provide such information to such a person on the Secretary’s own initiative during the review of an abbreviated application under this subsection for such drug.</text></clause><clause id="HD10AC80BC0244761A5895F7DEB720CCC" indent="up1" changed="not-changed"><enum>(ii)</enum><text>Notwithstanding section 301(j), if the Secretary determines that such drug is not qualitatively or quantitatively the same as the listed drug, the Secretary shall identify and disclose to the person—</text><subclause id="H300AC59E8E7C4A108A8C4C6CAAB5EA9B" changed="not-changed"><enum>(I)</enum><text>the ingredient or ingredients that cause such drug not to be qualitatively or quantitatively the same as the listed drug; and</text></subclause><subclause id="H95BD58AD10BC40AD9F0D745767F7BA06" changed="not-changed"><enum>(II)</enum><text>for any ingredient for which there is an identified quantitative deviation, the amount of such deviation.</text></subclause></clause><clause id="H18AA55D0D90D485785F5A74332C10283" indent="up1" changed="not-changed"><enum>(iii)</enum><text display-inline="yes-display-inline">If the Secretary determines that such drug is qualitatively and quantitatively the same as the listed drug, the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such drug under this subsection unless—</text><subclause id="H72CF25A60CFF472287A84C795DC0C070" changed="not-changed"><enum>(I)</enum><text>the formulation of the listed drug has been changed and the Secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness; or</text></subclause><subclause id="H9C2B4B463BBB432C97C80F9FBD304B4F" changed="not-changed"><enum>(II)</enum><text>the Secretary makes a written determination that the prior determination must be changed because an error has been identified. </text></subclause></clause><clause id="H0927FABF7F034E5F98205B631251648A" indent="up1" changed="not-changed"><enum>(iv)</enum><text display-inline="yes-display-inline">If the Secretary makes a written determination described in clause (iii)(II), the Secretary shall provide notice and a copy of the written determination to the person making the request under clause (i).</text></clause><clause id="H089BB3E3369540FA9202335F56B74187" indent="up1" changed="not-changed"><enum>(v)</enum><text>The disclosures authorized under clauses (i) and (ii) are disclosures authorized by law, including for purposes of section 1905 of title 18, United States Code. This subparagraph shall not otherwise be construed to authorize the disclosure of nonpublic qualitative or quantitative information about the ingredients in a listed drug, or to affect the status, if any, of such information as trade secret or confidential commercial information for purposes of section 301(j) of this Act, section 552 of title 5, United States Code, or section 1905 of title 18, United States Code.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="H1AAA56D1E5C44BC1955D2F4C76DDCC72" changed="not-changed"><enum>(b)</enum><header>Guidance</header><paragraph id="H8DA6BD9D096F4BC1A1FB5CE78DDEAC5F" changed="not-changed"><enum>(1)</enum><header>In general</header><text>Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance, or update guidance, describing how the Secretary will determine whether a drug is qualitatively and quantitatively the same as the listed drug (as such terms are used in section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)), including with respect to assessing pH adjusters.</text></paragraph><paragraph id="H24D3F517676E4A4BA261B3003C2B006F" changed="not-changed"><enum>(2)</enum><header>Process</header><text display-inline="yes-display-inline">In issuing guidance under this subsection, the Secretary of Health and Human Services shall—</text><subparagraph id="HE8AFE0C046FD425BAE6E6826C54E62E5" changed="not-changed"><enum>(A)</enum><text>publish draft guidance;</text></subparagraph><subparagraph id="HBE7BB883501F49569437764B6EB6257B" changed="not-changed"><enum>(B)</enum><text>provide a period of at least 60 days for comment on the draft guidance; and</text></subparagraph><subparagraph id="H46E404139E80421AA104B1287407C0B4" changed="not-changed"><enum>(C)</enum><text>after considering any comments received and not later than one year after the close of the comment period on the draft guidance, publish final guidance.</text></subparagraph></paragraph></subsection><subsection id="H1A5B713C30CE48DCBC5C8EF07BF1C159" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(c)</enum><header>Applicability</header><text>Section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies beginning on the date of enactment of this Act, irrespective of the date on which the guidance required by subsection (b) is finalized. </text></subsection></section><section id="HED9FECB6F70C48878E599E0D7E53D4EF" changed="not-changed" commented="no" display-inline="no-display-inline" section-type="subsequent-section"><enum>904.</enum><header display-inline="yes-display-inline">Title 35 amendments</header><subsection id="H422D2C991F0D471BAB8E73794658FC48" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 271(e) of title 35, United States Code, is amended—</text><paragraph id="HE70F41834AA345A79F666D13A5EB99CF" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (2)(C), in the flush text following clause (ii), by adding at the end the following: <quote>With respect to a submission described in clause (ii), the act of infringement shall extend to any patent that claims the biological product, a method of using the biological product, or a method or product used to manufacture the biological product.</quote>; and</text></paragraph><paragraph id="HED3F77C842E24783BB5C9466A4A98D13" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H48EA9190BE8F49CA981AC2CA3005AB4C" changed="not-changed"><paragraph id="H92D93923E8AF4268994E57C0DB68E433" indent="up1" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(7)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HC595D2F9A1554E188954458493AD7223" changed="not-changed"><enum>(A)</enum><text display-inline="yes-display-inline">Subject to subparagraphs (C), (D), and (E), if the sponsor of an approved application for a reference product, as defined in section 351(i) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(i)</external-xref>) (referred to in this paragraph as the <quote>reference product sponsor</quote>), brings an action for infringement under this section against an applicant for approval of a biological product under section 351(k) of such Act that references that reference product (referred to in this paragraph as the <quote>subsection (k) applicant</quote>), the reference product sponsor may assert in the action a total of not more than 20 patents of the type described in subparagraph (B), not more than 10 of which shall have issued after the date specified in section 351(l)(7)(A) of such Act.</text></subparagraph><subparagraph id="HD7F3D93BEE284C97B1207DDC13CC5FC7" indent="up1" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(B)</enum><text display-inline="yes-display-inline">The patents described in this subparagraph are patents that satisfy each of the following requirements:</text><clause id="HAD0826C0628C4423A6674032AEDDC363" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(i)</enum><text display-inline="yes-display-inline">Patents that claim the biological product that is the subject of an application under section 351(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)</external-xref>) (or a use of that product) or a method or product used in the manufacture of such biological product.</text></clause><clause id="HB20E407112F24B35B3B291DA1ABF1942" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text display-inline="yes-display-inline">Patents that are included on the list of patents described in paragraph (3)(A) of section 351(l) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(l)</external-xref>), including as provided under paragraph (7) of such section 351(l).</text></clause><clause id="H20211C6ECA6C4A08AF661634FBD2C73F" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(iii)</enum><text display-inline="yes-display-inline">Patents that—</text><subclause id="H1AFF3B4760DB48C29B8157BD2B09D30C" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(I)</enum><text display-inline="yes-display-inline">have an actual filing date of more than 4 years after the date on which the reference product is approved; or</text></subclause><subclause id="H0F6B352E84F946FA9E9A754D4CA2922F" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(II)</enum><text display-inline="yes-display-inline">include a claim to a method in a manufacturing process that is not used by the reference product sponsor.</text></subclause></clause></subparagraph><subparagraph id="HD5CF8774BFBA4934B793CF4316B7BCF2" indent="up1" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(C)</enum><text display-inline="yes-display-inline">The court in which an action described in subparagraph (A) is brought may increase the number of patents limited under that subparagraph—</text><clause id="H316BBF1249594A92A3A484647936DDBB" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(i)</enum><text display-inline="yes-display-inline">if the request to increase that number is made without undue delay; and</text></clause><clause id="HCCBBAD6ED23A46A8A5CE7170EBF8B018" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><subclause commented="no" display-inline="yes-display-inline" id="H719130C2ACD549A09200334F34BA1D71" changed="not-changed"><enum>(I)</enum><text display-inline="yes-display-inline">if the interest of justice so requires; or</text></subclause><subclause id="H8191F363E2834DE9AB183958DB8F6120" indent="up1" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(II)</enum><text display-inline="yes-display-inline">for good cause shown, which—</text><item id="H6C5B6C9617FC47698F39342364970655" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(aa)</enum><text display-inline="yes-display-inline">shall be established if the subsection (k) applicant fails to provide information required under section 351(k)(2)(A) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)(2)(A)</external-xref>) that would enable the reference product sponsor to form a reasonable belief with respect to whether a claim of infringement under this section could reasonably be asserted; and</text></item><item id="H2D43B28F749144E4984F48C38B59D511" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(bb)</enum><text display-inline="yes-display-inline">may be established—</text><subitem id="HE49742EDA32B439F9F63999998D9B4D4" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(AA)</enum><text display-inline="yes-display-inline">if there is a material change to the biological product (or process with respect to the biological product) of the subsection (k) applicant that is the subject of the application;</text></subitem><subitem id="HFF185FAC4B3B45438B4E66B6CFE3DA5F" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(BB)</enum><text display-inline="yes-display-inline">if, with respect to a patent on the supplemental list described in section 351(l)(7)(A) of Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(l)(7)(A)</external-xref>), the patent would have issued before the date specified in such section 351(l)(7)(A) but for the failure of the Office to issue the patent or a delay in the issuance of the patent, as described in paragraph (1) of section 154(b) and subject to the limitations under paragraph (2) of such section 154(b); or</text></subitem><subitem id="H135EF1174A8D4E538981E5764859291B" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(CC)</enum><text display-inline="yes-display-inline">for another reason that shows good cause, as determined appropriate by the court.</text></subitem></item></subclause></clause></subparagraph><subparagraph id="H6A483DC98A0D42BA83ABAE1595D3DBD7" indent="up1" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(D)</enum><text display-inline="yes-display-inline">In determining whether good cause has been shown for the purposes of subparagraph (C)(ii)(II), a court may consider whether the reference product sponsor has provided a reasonable description of the identity and relevance of any information beyond the subsection (k) application that the court believes is necessary to enable the court to form a belief with respect to whether a claim of infringement under this section could reasonably be asserted.</text></subparagraph><subparagraph id="H4A91CA4480AF4A87A9BB82359C28746E" indent="up1" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(E)</enum><text display-inline="yes-display-inline">The limitation imposed under subparagraph (A)—</text><clause id="H74E42A1FCD5C4EC2B318C344F1A8A0AD" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(i)</enum><text display-inline="yes-display-inline">shall apply only if the subsection (k) applicant completes all actions required under paragraphs (2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of section 351(l) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(l)</external-xref>); and</text></clause><clause id="H0E8820C962CF421B97D3181FCB7F01C3" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(ii)</enum><text display-inline="yes-display-inline">shall not apply with respect to any patent that claims, with respect to a biological product, a method for using that product in therapy, diagnosis, or prophylaxis, such as an indication or method of treatment or other condition of use.</text></clause></subparagraph></paragraph><after-quoted-block display="yes">.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="HF058AD508A89406B83C7928376E91391" changed="not-changed" commented="no" display-inline="no-display-inline"><enum>(b)</enum><header display-inline="yes-display-inline">Applicability</header><text display-inline="yes-display-inline">The amendments made by subsection (a) shall apply with respect to an application submitted under section 351(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(k)</external-xref>) on or after the date of enactment of this Act.</text></subsection></section></title><title id="HEEA0F976F62A43C19640CB36069FB65A"><enum>X</enum><header>Miscellaneous</header><section id="H499E0FB39D6E4DFBAE0D2A154A15E210"><enum>1001.</enum><header>Two-year extension of safe harbor for absence of deductible for telehealth</header><subsection id="HEED8E5BBC38B4AEAB01EE80E5B61A655"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/223">Section 223(c)(2)(E)(ii)</external-xref> of the Internal Revenue Code of 1986 is amended by striking <quote>January 1, 2025</quote> and inserting <quote>January 1, 2027</quote>.</text></subsection><subsection id="HC5DBC7F85B5940C2998E59133C62CAE4"><enum>(b)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendments made by this section shall apply to plan years beginning after December 31, 2024.</text></subsection></section></title></division></legis-body></bill> 

