Pub. L. 116-260, div. M, tit. III, under "Office of the Secretary"
Office of the Secretary
Office of the Secretary Public Health and Social Services Emergency Fund (including transfer of funds) For an additional amount for “Public Health and Social Services Emergency Fund”, $22,945,000,000, to remain available until September 30, 2024, to prevent, prepare for, and respond to coronavirus, domestically or internationally, including the development of necessary countermeasures and vaccines, prioritizing platform-based 134 STAT. 1917 technologies with U.S.-based manufacturing capabilities, the purchase of vaccines, therapeutics, diagnostics, necessary medical supplies, as well as medical surge capacity, and other preparedness and response activities: Provided, That funds appropriated under this paragraph in this Act may be used to develop and demonstrate innovations and enhancements to manufacturing platforms to support such capabilities: Provided further, That the Secretary of Health and Human Services (referred to under this heading as “Secretary”) shall purchase vaccines developed using funds made available under this paragraph in this Act to respond to an outbreak or pandemic related to coronavirus in quantities determined by the Secretary to be adequate to address the public health need: Provided further, That the Secretary may take into account geographical areas with a high percentage of cross-jurisdictional workers when determining allocations of vaccine doses: Provided further, That products purchased by the Federal government with funds made available under this paragraph in this Act, including vaccines, therapeutics, and diagnostics, shall be purchased in accordance with Federal Acquisition Regulation guidance on fair and reasonable pricing: Provided further, That the Secretary may take such measures authorized under current law to ensure that vaccines, therapeutics, and diagnostics developed from funds provided in this Act will be affordable in the commercial market: Provided further, That in carrying out the preceding proviso, the Secretary shall not take actions that delay the development of such products: Provided further, That products purchased with funds appropriated under this paragraph in this Act may, at the discretion of the Secretary of Health and Human Services, be deposited in the Strategic National Stockpile under section 319F–2 of the Public Health Service Act: Provided further, That of the amount appropriated under this paragraph in this Act, not more than $3,250,000,000 shall be for the Strategic National Stockpile under section 319F–2(a) of such Act: Provided further, That funds appropriated under this paragraph in this Act may be transferred to, and merged with, the fund authorized by section 319F–4, the Covered Countermeasure Process Fund, of the Public Health Service Act: Provided further, That of the amount appropriated under this paragraph in this Act, $19,695,000,000 shall be available to the Biomedical Advanced Research and Development Authority for necessary expenses of manufacturing, production, and purchase, at the discretion of the Secretary, of vaccines, therapeutics, and ancillary supplies necessary for the administration of such vaccines and therapeutics: Provided further, That funds in the preceding proviso may be used for the construction or renovation of U.S.-based next generation manufacturing facilities, other than facilities owned by the United States Government: Provided further, That the Secretary shall notify the Committees on Appropriations of the House of Representatives and the Senate 2 days in advance of any obligation in excess of $50,000,000, including but not limited to contracts and interagency agreements, from funds provided in this paragraph in this Act: Provided further, That amounts appropriated under this paragraph in this Act may be used to restore, either directly or through reimbursement, obligations incurred for coronavirus vaccines and therapeutics planning, development, preparation, and purchase prior to the enactment of this Act: Provided further, That funds appropriated under this paragraph in this Act may be used for the construction, alteration, or renovation 134 STAT. 1918 of non-federally owned facilities for the production of vaccines, therapeutics, diagnostics, and ancillary medical supplies where the Secretary determines that such a contract is necessary to secure sufficient amounts of such supplies: Provided further, That not later than 30 days after enactment of this Act, and every 30 days thereafter until funds are expended, the Secretary shall report to the Committees on Appropriations of the House of Representatives and the Senate on uses of funding for Operation Warp Speed, detailing current obligations by Department or Agency, or component thereof broken out by the coronavirus supplemental appropriations Act that provided the source of funds: Provided further, That the plan outlined in the preceding proviso shall include funding by contract, grant, or other transaction in excess of $20,000,000 with a notation of which Department or Agency, and component thereof is managing the contract: Provided further, That such amount is designated by the Congress as being for an emergency requirement pursuant to section 251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control Act of 1985. For an additional amount for “Public Health and Social Services Emergency Fund”, $22,400,000,000, to remain available until September 30, 2022, to prevent, prepare for, and respond to coronavirus, domestically or internationally, which shall be for necessary expenses for testing, contact tracing, surveillance, containment, and mitigation to monitor and suppress COVID–19, including tests for both active infection and prior exposure, including molecular, antigen, and serological tests, the manufacturing, procurement and distribution of tests, testing equipment and testing supplies, including personal protective equipment needed for administering tests, the development and validation of rapid, molecular point-of-care tests, and other tests, support for workforce, epidemiology, to scale up academic, commercial, public health, and hospital laboratories, to conduct surveillance and contact tracing, support development of COVID–19 testing plans, and other related activities related to COVID–19 testing and mitigation: Provided, That amounts appropriated under this paragraph in this Act shall be for States, localities, territories, tribes, tribal organizations, urban Indian health organizations, or health service providers to tribes for necessary expenses for testing, contact tracing, surveillance, containment, and mitigation, including support for workforce, epidemiology, use by employers, elementary and secondary schools, child care facilities, institutions of higher education, long-term care facilities, or in other settings, scale up of testing by public health, academic, commercial, and hospital laboratories, and community-based testing sites, mobile testing units, health care facilities, and other entities engaged in COVID–19 testing, and other related activities related to COVID–19 testing, contact tracing, surveillance, containment, and mitigation which may include interstate compacts or other mutual aid agreements for such purposes: Provided further, That amounts appropriated under this paragraph in this Act shall be made available within 21 days of the date of enactment of this Act: Provided further, That of the amount appropriated under this paragraph in this Act, $790,000,000, shall be transferred to the “Department of Health and Human Services—Indian Health Service—Indian Health Services” to be allocated at the discretion of the Director of the Indian Health Service and distributed through Indian Health Service directly operated programs and to tribes and tribal organizations under the Indian Self-Determination and 134 STAT. 1919 Education Assistance Act and through contracts or grants with urban Indian organizations under title V of the Indian Health Care Improvement Act: Provided further, That the amount transferred to tribes and tribal organizations under the Indian Self-Determination and Education Assistance Act in the preceding proviso shall be transferred on a one-time, non-recurring basis, is not part of the amount required by 25 U.S.C. 5325, and may only be used for the purposes identified under this paragraph in this Act, notwithstanding any other provision of law: Provided further, That amounts appropriated under this paragraph in this Act, except for the amounts transferred pursuant to the third proviso under this paragraph in this Act, shall be allocated to States, localities, and territories according to the formula that applied to the Public Health Emergency Preparedness cooperative agreement in fiscal year 2020: Provided further, That of the amount appropriated under this paragraph in this Act, except for the amounts transferred pursuant to the third proviso under this paragraph in this Act, not less than $2,500,000,000, shall be for strategies for improving testing capabilities and other purposes described in this paragraph in high-risk and underserved populations, including racial and ethnic minority populations and rural communities, as well as developing or identifying best practices for States and public health officials to use for contact tracing in high-risk and underserved populations, including racial and ethnic minority populations and rural communities and shall not be allocated pursuant to the formula in the preceding proviso: Provided further, That the second proviso under this paragraph in this Act, shall not apply to amounts in the preceding proviso: Provided further, That the Secretary of Health and Human Services (referred to in this paragraph as the “Secretary”) may satisfy the funding thresholds outlined under this paragraph in this Act for funding other than amounts transferred pursuant to the third proviso under this paragraph in this Act by making awards through other grant or cooperative agreement mechanisms: Provided further, That the Governor or designee of each State, locality, territory, tribe, or tribal organization receiving funds pursuant to this paragraph in this Act shall update their plans, as applicable, for COVID–19 testing and contact tracing submitted to the Secretary pursuant to the Paycheck Protection Program and Health Care Enhancement Act (Public Law 116–139) and submit such updates to the Secretary not later than 60 days after funds appropriated in this paragraph in this Act have been awarded to such recipient: Provided further, That not later than 60 days after enactment of this Act, and every quarter thereafter until funds are expended, the Governor or designee of each State, locality, territory, tribe, or tribal organization receiving funds shall report to the Secretary on uses of funding, detailing current commitments and obligations broken out by the coronavirus supplemental appropriations Act that provided the source of funds: Provided further, That not later than 15 days after receipt of such reports, the Secretary shall summarize and report to the Committees on Appropriations of the House of Representatives and the Senate and the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on States’ commitments and obligations of funding: Provided further, That the Secretary shall make publicly available the plans submitted by the Governor or designee of each State, locality, territory, tribe, or tribal organization and the report 134 STAT. 1920 on use of funds provided under this paragraph: Provided further, That funds an entity receives from amounts described in the first proviso in this paragraph may also be used for the rent, lease, purchase, acquisition, construction, alteration, renovation, or equipping of non-federally owned facilities to improve coronavirus preparedness and response capability at the State and local level: Provided further, That the Secretary shall provide a report to the Committees on Appropriations of the House of Representatives and the Senate on obligation of funds to eligible entities pursuant to the sixth proviso, summarized by State, not later than 30 days after the date of enactment of this Act, and every 60 days thereafter until funds are expired: Provided further, That such amount is designated by the Congress as being for an emergency requirement pursuant to section 251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control Act of 1985. For an additional amount for “Public Health and Social Services Emergency Fund”, $3,000,000,000, to remain available until expended, to prevent, prepare for, and respond to coronavirus, domestically or internationally, which shall be for necessary expenses to reimburse, through grants or other mechanisms, eligible health care providers for health care related expenses or lost revenues that are attributable to coronavirus: Provided, That these funds may not be used to reimburse expenses or losses that have been reimbursed from other sources or that other sources are obligated to reimburse: Provided further, That recipients of payments under this paragraph shall submit reports and maintain documentation as the Secretary determines are needed to ensure compliance with conditions that are imposed by this paragraph for such payments, and such reports and documentation shall be in such form, with such content, and in such time as the Secretary may prescribe for such purpose: Provided further, That “eligible health care providers” means public entities, Medicare or Medicaid enrolled suppliers and providers, and such for-profit entities and not-for-profit entities not otherwise described in this proviso as the Secretary may specify, within the United States (including territories), that provide diagnoses, testing, or care for individuals with possible or actual cases of COVID–19: Provided further, That the Secretary shall, on a rolling basis, review applications and make payments under this paragraph in this Act: Provided further, That funds appropriated under this paragraph in this Act shall be available for building or construction of temporary structures, leasing of properties, medical supplies and equipment including personal protective equipment and testing supplies, increased workforce and trainings, emergency operation centers, retrofitting facilities, and surge capacity: Provided further, That, in this paragraph, the term “payment” means a pre-payment, prospective payment, or retrospective payment, as determined appropriate by the Secretary: Provided further, That payments under this paragraph shall be made in consideration of the most efficient payment systems practicable to provide emergency payment: Provided further, That to be eligible for a payment under this paragraph in this Act, an eligible health care provider shall submit to the Secretary an application that includes a statement justifying the need of the provider for the payment and the eligible health care provider shall have a valid tax identification number: Provided further, That for any reimbursement by the Secretary from the Provider Relief Fund to an eligible health care provider that is a subsidiary of a parent organization, 134 STAT. 1921 the parent organization may, allocate (through transfers or otherwise) all or any portion of such reimbursement among the subsidiary eligible health care providers of the parent organization, including reimbursements referred to by the Secretary as “Targeted Distribution” payments, among subsidiary eligible health care providers of the parent organization except that responsibility for reporting the reallocated reimbursement shall remain with the original recipient of such reimbursement: Provided further, That, for any reimbursement from the Provider Relief Fund to an eligible health care provider for health care related expenses or lost revenues that are attributable to coronavirus (including reimbursements made before the date of the enactment of this Act), such provider may calculate such lost revenues using the Frequently Asked Questions guidance released by the Department of Health and Human Services in June 2020, including the difference between such provider’s budgeted and actual revenue budget if such budget had been established and approved prior to March 27, 2020: Provided further, That of the amount made available in the third paragraph under this heading in Public Law 116–136, not less than 85 percent of (i) the unobligated balances available as of the date of enactment of this Act, and (ii) any funds recovered from health care providers after the date of enactment of this Act, shall be for any successor to the Phase 3 General Distribution allocation to make payments to eligible health care providers based on applications that consider financial losses and changes in operating expenses occurring in the third or fourth quarter of calendar year 2020, or the first quarter of calendar year 2021, that are attributable to coronavirus: Provided further, That, not later than 3 years after final payments are made under this paragraph, the Office of Inspector General of the Department of Health and Human Services shall transmit a final report on audit findings with respect to this program to the Committees on Appropriations of the House of Representatives and the Senate: Provided further, That nothing in this section limits the authority of the Inspector General or the Comptroller General to conduct audits of interim payments at an earlier date: Provided further, That not later than 60 days after the date of enactment of this Act, the Secretary of Health and Human Services shall provide a report to the Committees on Appropriations of the House of Representatives and the Senate on obligation of funds, including obligations to such eligible health care providers, summarized by State of the payment receipt: Provided further, That such reports shall be updated and submitted to such Committees every 60 days until funds are expended: Provided further, That the amounts repurposed in this paragraph that were previously designated by the Congress as an emergency requirement pursuant to the Balanced Budget and Emergency Deficit Control Act of 1985 are designated by the Congress as an emergency requirement pursuant to section 251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control Act of 1985: Provided further, That such amount is designated by the Congress as being for an emergency requirement pursuant to section 251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control Act of 1985.134 STAT. 1922