# Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/crs%3AR46334 ## Record - **Collection:** Congressional research report - **Document type:** CRS Report - **Published:** April 29, 2020 - **Citation:** R46334 ## Text Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) Elayne J. Heisler, Coordinator Specialist in Health Services April 29, 2020 Congressional Research Service 7-.... www.crs.gov R46334 SUMMARY Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) The global pandemic of Coronavirus Disease 2019 (COVID-19) is affecting communities around the world and throughout the United States, with the number of confirmed cases and fatalities growing daily. Containment and mitigation efforts by U.S. federal, state, and local governments have been undertaken to “flatten the curve”—that is, to slow the widespread transmission that could overwhelm the nation’s health care system. R46334 April 29, 2020 Elayne J. Heisler, Coordinator Specialist in Health Services -re-acte--@crs.loc.gov For a copy of the full report, please call 7-.... or visit www.crs.gov. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act, P.L. 116-136) was enacted on March 27, 2020. It is the third comprehensive law enacted in 2020 to address the pandemic. In addition to a number of broad health care provisions, the CARES Act provides additional supplemental appropriations to support federal response efforts and authorizes a number of economic stimulus measures, among other things. This report describes the majority of health-related sections in Division A, Title III, of the CARES Act, “Supporting America’s Health Care System in the Fight Against the Coronavirus.” Relevant background is provided for context. Specifically, this report describes provisions regarding, among other things, the following:  The availability of medical countermeasures (MCMs)—drugs, tests, treatments, medical devices, and supplies such as personal protective equipment (PPE)—including research and development; product regulation by the Food and Drug Administration (FDA); the Strategic National Stockpile (SNS); and other supply chain matters.  The health workforce, including telehealth programs, the rural health care system, and the Commissioned Corps of the U.S. Public Health Service (USPHS). Additional workforce provisions described in this report include reauthorization and extension of appropriations for existing HHS health workforce programs, and liability limitation.  Provisions addressed at the Medicare and Medicaid programs and on private health insurance plans that temporarily require, or increase payment for, telehealth services and specified services related to COVID19 testing, diagnosis, or treatment.  A newly established FDA authority for over-the-counter (OTC) drug review. This report does not address education or labor provisions in Subtitle B or C in Part IV of Title III, or provisions in Subtitle E of Part IV of Title III, “Health and Human Services Extenders,” which are described in other CRS reports. The report also does not include Division B of the act, which provides emergency supplemental appropriations for the COVID-19 response. The Appendix catalogues deadlines, effective dates, and reporting requirements for provisions described in the report. This report is intended to reflect the CARES Act at enactment (i.e., March 27, 2020). It does not track the law’s implementation or funding and will not be updated. Congressional Research Service Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) Contents Introduction ..................................................................................................................................... 1 A Snapshot of CARES Act Health Provisions .......................................................................... 1 Report Contents......................................................................................................................... 2 Definitions, Abbreviations, and Acronyms ............................................................................... 4 “Section 319” Public Health Emergency ............................................................................ 4 Additional Definitions and Acronyms ................................................................................ 4 CARES Act Health Provisions in Title III ....................................................................................... 7 Subtitle A—Health Provisions .................................................................................................. 7 Part I—Addressing Supply Shortages—Subpart A—Medical Product Supplies ............... 7 Subpart B—Mitigating Emergency Drug Shortages......................................................... 10 Subpart C—Preventing Medical Device Shortages .......................................................... 12 Part II—Access to Health Care for COVID-19 Patients................................................... 13 Subpart A—Coverage of Testing and Preventive Services ............................................... 13 Subpart B—Support for Health Care Providers ................................................................ 17 Subpart C—Miscellaneous Provisions ............................................................................. 23 Part III—Innovation .......................................................................................................... 30 Part IV—Health Care Workforce ...................................................................................... 31 Subtitle D—Finance Committee ............................................................................................. 38 Subtitle F—Over-the-Counter Drugs ...................................................................................... 55 Part I—OTC Drug Review ............................................................................................... 55 Part II—User Fees............................................................................................................. 58 Tables Table 1. Acronyms Used in This Report.......................................................................................... 4 Table A-1. Title III CARES Act Provisions with Implementation Dates, Reporting Requirements, and Deadlines ..................................................................................................... 61 Appendixes Appendix. Health Provisions in Title III of the CARES Act: Implementation Dates, Reporting Requirements, and Deadlines .................................................................................... 60 Contacts Author Contact Information .......................................................................................................... 68 Congressional Research Service Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) Introduction The global pandemic of Coronavirus Disease 2019 (COVID-19) is affecting communities around the world and throughout the United States, with the number of confirmed cases and fatalities growing daily. Containment and mitigation efforts by U.S. federal, state, and local governments have been undertaken to “flatten the curve”—that is, to slow the widespread transmission that could overwhelm the nation’s health care system.1 The Coronavirus Aid, Relief, and Economic Security Act (CARES Act, P.L. 116-136) was enacted on March 27, 2020. It is the third comprehensive law to address the pandemic. In addition to its health provisions, the CARES Act provides additional supplemental appropriations to support federal response efforts and authorizes a number of economic stimulus measures, among other things. The CARES Act follows two other laws that made supplemental appropriations and amended health care financing and public health authorities to respond to the pandemic. The first, the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123), enacted on March 6, 2020, provides roughly $7.8 billion in discretionary supplemental appropriations to the Department of Health and Human Services (HHS), the Department of State, and the Small Business Administration.2 This act also waives certain telehealth restrictions to make telehealth services more available during the emergency.3 The second, the Families First Coronavirus Response Act (FFCRA, P.L. 116-127), enacted on March 18, 2020, provides authority, funding, and/or requirements to cover COVID-19 testing and related services under federal programs, many private health insurance plans, and for the uninsured (as defined in the act). Among other provisions, it temporarily increases the federal share of Medicaid assistance to states, provides additional Medicaid assistance to territories, and waives liability and establishes injury compensation for certain respiratory protection devices.4 A Snapshot of CARES Act Health Provisions Medical supply shortages. The COVID-19 pandemic has affected the medical product supply chain both globally and domestically, resulting in widespread shortages of medical countermeasures (MCMs) and other critical medical supplies. MCMs are medical products that may be used to treat, prevent, or diagnose conditions associated with emerging infectious diseases or chemical, biological, radiological, or nuclear threats. Examples of MCMs include biologics (e.g., vaccines), drugs (e.g., antivirals), and devices (e.g., diagnostic tests and personal protective equipment, or PPE). The CARES Act includes several provisions to address such shortages, including expanding reporting requirements for firms that experience interruptions in drug and device manufacturing; explicitly requiring that the Strategic National Stockpile (SNS) contain PPE, ancillary medical supplies, and other applicable supplies; and extending liability protections for certain respiratory protective devices used during emergencies. The CARES Act also requires a study of U.S. 1 For an overview of domestic Coronavirus Disease 2019 (COVID-19) health response efforts and a compilation of federal agency websites, see CRS Insight IN11253, Domestic Public Health Response to COVID-19: Current Status. 2 CRS Report R46285, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116123): First Coronavirus Supplemental; and CRS Insight IN11236, Oversight Provisions in H.R. 6074, the Coronavirus Preparedness and Response Supplemental Appropriations Act. 3 CRS Report R46239, Telehealth and Telemedicine: Frequently Asked Questions. 4 CRS Report R46316, Health Care Provisions in the Families First Coronavirus Response Act, P.L. 116-127. Congressional Research Service 1 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) dependence on critical drugs and medical devices imported from or manufactured in other countries. Vaccine access and cost. A vaccine(s) for the COVID-19 virus, if and when it becomes available, will be provided or required to be covered without cost-sharing to patients and beneficiaries of federal health programs and most private health insurance enrollees, pursuant to numerous provisions in Division A, Title III, of the CARES Act. The CARES Act does not explicitly address vaccine access for the uninsured. However, with available appropriations and preexisting authorities, the HHS Secretary could assist safety net providers (e.g., health centers), health departments, and other entities in furnishing vaccines to this population. The medical workforce. The CARES Act makes a number of changes to health workforce programs. Some changes aim to extend the services available during the COVID-19 period and beyond, particularly for rural or otherwise underserved populations. For example, the CARES Act confers medical malpractice liability on health professionals who choose to volunteer during the emergency period and amends the program rules for the National Health Service Corps (NHSC) program to permit individuals to volunteer during the emergency period. The CARES Act also reauthorizes a number of health workforce programs that had been considered for reauthorization during the 116th Congress, but prior to the CARES Act no reauthorization of these programs was enacted. Marketing of over-the-counter drugs. The CARES Act establishes a new process for the marketing of certain over-the-counter (OTC) drugs, including hand sanitizer and sunscreen. Specifically, Title III replaces the current OTC drug monograph rulemaking process with an administrative order process—a less burdensome alternative. It also provides an expedited process for removing from the market certain OTC drugs that pose a public health hazard and for requiring certain safety labeling changes. The CARES Act provides an incentive—18 months of marketing exclusivity—to firms that make certain changes to previously marketed OTC drugs and creates a new user fee program to fund FDA’s OTC monograph drug activities. Report Contents This report describes the majority of health-related sections in Division A, Title III of the CARES Act, “Supporting America’s Health Care System in the Fight Against the Coronavirus.” Relevant background is provided for context. Specifically, this report describes provisions regarding, among other things the following:     The medical countermeasures (MCMs)—drugs, tests, treatments, medical devices, and supplies such as PPE—including research and development; product regulation by the Food and Drug Administration (FDA); the strategic national stockpile (SNS); and other supply chain matters. The health workforce, including telehealth programs, the rural health care system, and the Commissioned Corps of the U.S. Public Health Service (USPHS). Additional workforce provisions described in this report include reauthorization and extension of appropriations for existing Health and Human Services (HHS) health workforce programs, and liability limitation. Provisions addressed at the Medicare and Medicaid programs and on private health insurance plans to temporarily require, or increase payment for, telehealth services and specified services related to COVID-19 testing, diagnosis, or treatment. A newly established FDA authority for OTC drug review. Congressional Research Service 2 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) This report does not address education or labor provisions in Subtitle B or C in Part IV of Title III, 5 or provisions in Subtitle E of Part IV of Title III, “Health and Human Services Extenders,” which are described in another CRS report.6 The report also does not include Division B of the act, which provides emergency supplemental appropriations for the COVID-19 response. Division B includes additional funding for numerous HHS public health and social services activities, and a $100 billion fund to reimburse eligible health care providers for health carerelated expenses or lost revenues attributable to COVID-19.7 This report concludes with an Appendix that catalogues deadlines, effective dates, and reporting requirements for provisions described in the report. The report does not discuss cost estimates for specific provisions; however, the Congressional Budget Office (CBO) and the Joint Committee on Taxation (JCT) provided a preliminary estimate of the budget effects of the CARES Act.8 Overall, the act is estimated to increase federal deficits by $1.8 trillion over the 2020-2030 period. This estimate breaks down these budgetary effects into three categories: a $988 billion increase in mandatory outlays; a $446 billion decrease in revenues; and a $326 billion increase in discretionary outlays from supplemental appropriations. The estimates that CBO generated for health programs in Title III include programs in Subtitle E of Part IV of Title III, “Health and Human Services Extenders,” which are not discussed in this report. Among the provisions discussed in this report, JCT estimates that Section 3702, which expands the products that are eligible for tax-advantaged distributions from health savings accounts (HSAs), health flexible spending arrangements (FSAs), and other similar taxadvantaged savings arrangements, will reduce revenues by $9 billion over a ten-year period from 2020-2030. CBO also estimated the costs of a number of Medicare payment changes included in CARES Sections 3701-3715. These provisions generally increase the amount that Medicare will reimburse for services; as such, CBO estimates that they will increase Medicare spending from 2020-2030. CBO also noted that some provisions—e.g., the requirement for Medicare to cover the costs of vaccines for COVID-19—cannot be estimated because no such vaccine has been developed at this time. In general, these CBO estimates are based on assumptions about the severity and duration of the pandemic, and they may vary substantially from final estimates to be provided later this year. This report is intended to reflect the CARES Act at enactment (i.e., March 27, 2020). It does not track the law’s implementation or funding and will not be updated. This report is one of a number of CRS reports related to COVID-19; additional CRS products on COVID-19 are available at https://www.crs.gov/resources/coronavirus-disease-2019. 5 Education provisions are described in CRS In Focus IF11497, CARES Act Higher Education Provisions, and CRS In Focus IF11509, CARES Act Elementary and Secondary Education Provisions. 6 CRS Report R46331, Health Care-Related Expiring Provisions of the 116th Congress, Second Session. 7 For more information on the new fund, see U.S. Department of Health and Human Services (HHS), “CARES Act Provider Relief Fund,” April 13, 2020, https://www.hhs.gov/provider-relief/index.html. The Paycheck Protection Program and Health Care Enhancement Act enacted on April 24, 2020 (P.L. 116-139) appropriated an additional $75 billion to the CARES Act Provider Relief Fund and provided an additional $25 billion to HHS for COVID-19 testing. See CRS Report R46325, Fourth COVID-19 Relief Package (P.L. 116-139): In Brief. 8 For the complete preliminary cost estimate, see Congressional Budget Office, “Letter from Phillip L. Swagel, Director, Congressional Budget Office, to Honorable Mike B. Enzi, Chairman Senate Committee the Budget, U.S. Senate, April 16, 2020, https://www.cbo.gov/system/files/2020-04/hr748.pdf. Congressional Research Service 3 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) Definitions, Abbreviations, and Acronyms “Section 319” Public Health Emergency Numerous provisions in the CARES Act refer to the Public Health Emergency declaration made pursuant to Section 319 of the Public Health Service Act (PHSA). The “Section 319” authority allows the HHS Secretary to carry out a specified set of actions to address public health emergencies, such as expediting or waiving certain administrative requirements that would otherwise apply to federal activities or federally administered grants.9 Some provisions refer to “the emergency period declared under section 319” or similar construction, meaning the time during which a Section 319 declaration is in effect. The declaration for COVID-19 was made on January 31, 2020, retroactive to January 27, 2020. It is in effect for 90 days and is expected to be renewed and remain in effect for the duration of the response.10 Several provisions in Title III, Subtitle D, regarding health care financing and amending the Social Security Act (SSA), refer to “the emergency period described in section 1135(g)(1)(B)” or comparable construction. Section 1135 allows the HHS Secretary, under certain conditions, to waive specified requirements and regulations to ensure that health care items and services are available to enrollees in the Medicare, Medicaid, and State Children’s Health Insurance Program (CHIP) programs during emergencies.11 Paragraph (1)(B) of SSA Section 1135(g) refers specifically to “the public health emergency declared with respect to the COVID-19 outbreak by the Secretary on January 31, 2020, pursuant to section 319 of the [PHSA],” and any renewal of such declaration.12 Hence, these references to SSA Section 1135(g)(1)(B) simply mean the period during which the Section 319 public health emergency declaration for COVID-19—whether initial or renewed—is in effect. Additional Definitions and Acronyms Throughout this report, unless otherwise stated, the “Secretary” means the HHS Secretary. Mentions of “this section” refer to matters addressed under that specific section of the CARES Act. This report uses a number of acronyms, listed in the table below. Table 1. Acronyms Used in This Report Acronyms Definition AAA Area Agency on Aging ACA Patient Protection and Affordable Care Act (P.L. 111-148, as amended) ACIP Advisory Committee on Immunization Practices ACL Administration for Community Living 9 42 U.S.C. §247d. For more information, see HHS, “Public Health Emergency Declaration,” https://www.phe.gov/ Preparedness/legal/Pages/phedeclaration.aspx. 10 HHS, “Determination that a Public Health Emergency Exists Nationwide as the Result of the 2019 Novel Coronavirus,” January 31, 2020, https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. An emergency determination under Section 319 terminates after 90 days, unless terminated earlier by the HHS Secretary, and is renewable for additional 90-day periods. Section 319 emergencies declared in response to the 2009 H1N1 influenza pandemic and the 2016-2017 Zika virus outbreak were each renewed several times. 11 For more information, see CRS Legal Sidebar LSB10430, Section 1135 Waivers and COVID-19: An Overview. 12 This amendment to Section 1135 was made by the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, P.L. 116-123, div. B, §102(a)(1), (2), (b), March 6, 2020, 134 Stat. 156. Congressional Research Service 4 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) Acronyms Definition ANDA Abbreviated New Drug Application API Active Pharmaceutical Ingredient ASPR Assistant Secretary for Preparedness and Response BA Business Associate BARDA Biomedical Advanced Research and Development Authority BBA 2018 Bipartisan Budget Act of 2018 (P.L. 115-23) BBEDCA Balanced Budget and Emergency Deficit Control Act of 1985 (P.L. 99-177) BCA Budget Control Act of 2011 (P.L. 112-25) CAH Critical Access Hospital CARES Act Coronavirus Aid, Relief, and Economic Security Act (P.L. 116-136) CBO Congressional Budget Office CDC Centers for Disease Control and Prevention C.F.R. Code of Federal Regulations CHIP State Children’s Health Insurance Program CLFS Clinical Laboratory Fee Schedule CMS Centers for Medicare & Medicaid Services COGME Council on Graduate Medical Education COVID-19 Coronavirus Disease 2019 CPI Consumer Price Index CRS Congressional Research Service CSEOA Community Service Employment for Older Americans Program DME Durable Medical Equipment DMEPOS Durable Medical Equipment, Prosthetics, Orthotics and Supplies DOL Department of Labor DRI Dietary Reference Intakes EPA Environmental Protection Agency ESRD End-stage Renal Disease EUA Emergency Use Authorization FDA Food and Drug Administration FEHBP Federal Employees Health Benefits Program FFCRA Families First Coronavirus Response Act (P.L. 116-127) FFDCA Federal Food, Drug, and Cosmetic Act (P.L. 75-717, as amended) FMAP Federal Medical Assistance Percentage FORHP Federal Office of Rural Health Policy FQHC Federally Qualified Health Center FSA Flexible Spending Account FY Fiscal Year Congressional Research Service 5 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) Acronyms Definition GACA Geriatrics Academic Career Awards GAO Government Accountability Office GME Graduate Medical Education GRASE Generally Recognized as Safe and Effective GWEP Geriatrics Workforce Enhancement Program HBV Hepatitis Virus B HCBS Home and Community-based Services HDHP High-deductible Health Plan HHS Department of Health and Human Services HIPAA Health Insurance Portability and Accountability Act (P.L. 104-191, as amended) HPSA Health Professional Shortage Area HRA Health Reimbursement Arrangement HRSA Health Resources and Services Administration HSA Health Savings Account IHS Indian Health Service IMR Infant Mortality Rate IPPS Inpatient Prospective Payment System IRC Internal Revenue Code IRF Inpatient Rehabilitation Facility IRF PPS Inpatient Rehabilitation Facility Prospective Payment System IVD In Vitro Diagnostic JCT Joint Committee on Taxation LTCH Long-term Care Hospital LTCH PPS Long-term Care Hospital Inpatient Prospective Payment System LUPA Low-utilization Payment Adjustment MA Medicare Advantage MA-PD Medicare Advantage Prescription Drug Plan MCM Medical Countermeasure MPFS Medicare Physician Fee Schedule MS-DRG Medicare Severity-diagnosis Related Group MSA Medical Savings Account MUA Medically Underserved Area NASEM National Academies of Science, Engineering, and Medicine NDA New Drug Application NHSC National Health Service Corps NIH National Institutes of Health NIOSH National Institute for Occupational Safety and Health Congressional Research Service 6 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) Acronyms Definition OAA Older Americans Act (P.L. 89-73, as amended) OCR Office for Civil Rights (within the Department of Health and Human Services) OTA Other Transaction Authority OTC Over-The-Counter PAMA The Protecting Access to Medicare Act (P.L. 113-93) PDUFA Prescription Drug User Fee Act (P.L. 102-571) PHI Protected Health Information PHSA Public Health Service Act PPE Personal Protective Equipment PPS Prospective Payment System PREP Act Public Readiness and Emergency Preparedness Act (P.L. 109-417) RHC Rural Health Clinic SCSEP Senior Community Service Employment Program SG U.S. Surgeon General SIA Sunscreen Innovation Act (P.L. 113-195) SNS Strategic National Stockpile SSA Social Security Act STLDI Short-term, Limited Duration Insurance TNGP Telehealth Network Grant Program TRC Telehealth Resource Center USC United States Code USPHS U.S. Public Health Service USPSTF U.S. Preventive Services Task Force VPA Volunteer Protection Act of 1997 (P.L. 105-19) CARES Act Health Provisions in Title III Subtitle A—Health Provisions Part I—Addressing Supply Shortages—Subpart A—Medical Product Supplies The COVID-19 pandemic has affected the medical product supply chain both globally and domestically. Domestically, the pandemic has highlighted existing limitations in the U.S. medical product supply chain, including lack of transparency regarding where specific medical products and their components are manufactured and heavy reliance on foreign countries for drugs and medical devices. Perhaps most salient has been the impact of COVID-19 on the availability of PPE, such as respirators for health care personnel, and other respiratory devices, such as ventilators for patients. Although the federal government and states generally have stockpiles of PPE and ventilators to distribute during public health emergencies, stockpiled quantities have been insufficient to meet current needs. FDA, with other agencies, has taken various steps to Congressional Research Service 7 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) prevent and mitigate shortages of critical PPE and respiratory devices, for example, by waiving certain regulatory requirements and by enabling access to respirators and other medical devices that have not received agency clearance prior to marketing. Section 3101. National Academies Report on America’s Medical Product Supply Chain Security Background The extent to which the United States relies on other countries for medical products is not completely known, but available data suggest a heavy reliance. According to FDA, as of August 2019, 72% of facilities that manufacture active pharmaceutical ingredients (APIs) and 53% of facilities manufacturing finished drugs for the U.S. market are located outside of the United States.13 FDA is unable to determine the volume of APIs that a specific country manufactures for the domestic or global market. The 2019 annual report from the U.S.-China Economic and Security Review Commission states that the United States sources 80% of its APIs from foreign countries and has identified China as the world’s largest producer of APIs.14 Recent reports have identified limitations in FDA’s ability to oversee foreign drug manufacturing facilities and have indicated that FDA inspections of these facilities have decreased since 2016.15 The COVID-19 pandemic has further restricted FDA’s ability to oversee the increasingly globalized medical product supply chain, causing FDA to postpone most foreign facility inspections until at least May 2020.16 Provision Section 3101 requires the Secretary, within 60 days of enactment, to enter into an agreement with the National Academies of Science, Engineering, and Medicine (NASEM) to examine and report, “in a manner that does not compromise national security,” on the security of the U.S. medical product supply chain. The report must assess and evaluate U.S. dependence on critical drugs and devices from other countries; provide recommendations (e.g., a plan to improve resiliency of the supply chain); and address any supply vulnerabilities or potential disruptions that would significantly affect or pose a threat to public health or national security, as appropriate. In conducting the study and developing the report, NASEM must consider input from federal departments and agencies and consult with stakeholders through public meetings and other forms of engagement. 13 Food and Drug Administration (FDA), Testimony of Dr. Janet Woodcock, Director the Center for Drug Evaluation and Research, “Securing the U.S. Drug Supply Chain: Oversight of FDA’s Foreign Inspection Program,” December 10, 2019, https://www.fda.gov/news-events/congressional-testimony/securing-us-drug-supply-chain-oversight-fdasforeign-inspection-program-12102019. 14 2019 Report to Congress of the U.S. China Economic and Security Review Commission, 116 th Congress First Session, November 2019, Chapter 3 Section 3- “Growing U.S. Reliance on China’s Biotech and Pharmaceutical Products,” https://www.uscc.gov/annual-report/2019-annual-report. 15 See, for example, U.S. Government Accountability Office (GAO, Preliminary Findings Indicate Persistent Challenges with FDA Foreign Inspections, GAO-20-262T, December 10, 2019, https://www.gao.gov/products/GAO20-262T. 16 FDA Statement, “Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections,” March 10, 2020, https://www.fda.gov/news-events/press-announcements/coronavirus-disease-2019-covid-19-update-foreigninspections. Congressional Research Service 8 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) Section 3102. Requiring the Strategic National Stockpile to Include Certain Types of Medical Supplies Background The federal government maintains a supply of medicine and medical supplies to respond to a public health emergency severe enough to deplete local supplies (e.g., hurricane, infectious disease outbreak, or terrorist attack). This supply, known as the Strategic National Stockpile (SNS),17 includes antibiotics, intravenous fluids, and other medical supplies such as PPE and ventilators. In addition, the SNS contains certain medicines, such as anthrax and smallpox vaccines and treatments that may not be otherwise available for public use. In 2019, HHS stated the SNS contained approximately $8 billion worth of supplies.18 In FY2018, management of the SNS transferred from the Centers for Disease Control and Prevention (CDC) to the Assistant Secretary for Preparedness and Response (ASPR). Provision This section amends PHSA Section 319F-2(a)(1) to require the Secretary to maintain a stockpile of “drugs, vaccines and other biological products, medical devices, and other supplies.” This act further defines “other supplies” as “including PPE, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests in the stockpile.” Some of these types of supplies, such as PPE, were included in the stockpile even before enactment of this clarifying language. Section 3103. Treatment of Respiratory Protective Devices as Covered Countermeasures Background In 2005 Congress passed the Public Readiness and Emergency Preparedness Act (PREP Act, P.L. 109-417), which authorizes the federal government to waive liability (except for willful misconduct) for manufacturers, distributors, and providers of MCMs, such as drugs and medical supplies, needed to respond to a public health emergency.19 The act also authorizes the federal government to establish a program to compensate eligible individuals who suffer injuries from administration or use of products covered by the PREP Act’s immunity provisions.20 Section 6005 of FFCRA (P.L. 116-127) explicitly added personal respiratory protective devices used for the COVID-19 response to the list of countermeasures covered by the PREP Act.21 17 See HHS, Assistant Secretary for Preparedness and Response (ASPR), Public Health Emergency, “Strategic National Stockpile,” https://www.phe.gov/about/sns/Pages/default.aspx. 18 HHS, FY2021 Public Health and Social Services Emergency Fund Congressional Justification, p. 103. 19 HHS, ASPR, “Public Readiness and Emergency Preparedness Act,” https://www.phe.gov/Preparedness/legal/ prepact/Pages/default.aspx. 20 HHS, Health Resources and Services Administration (HRSA), “Countermeasures Injury Compensation Program (CICP),” https://www.hrsa.gov/cicp/index.html. 21 For more information on respiratory protective devices, and the certification program run by the National Institute for Occupational Safety and Health (NIOSH), see CRS In Focus IF11488, Personal Protective Equipment and Ventilators for COVID-19: FDA Regulation and Related Activities; and the Centers for Disease Control and Prevention (CDC), NIOSH, “National Personal Protective Technology Laboratory: About NPPTL,” https://www.cdc.gov/niosh/npptl/ about.html. Congressional Research Service 9 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) Provision Section 3103 amends PHSA Section 317F-3 to change the definition of such covered devices to apply more broadly, to “a respiratory protective device that is approved by the National Institute for Occupational Safety and Health (NIOSH) under part 84 of title 42, Code of Federal Regulations (or any successor regulations), and that the Secretary determines to be a priority for use during a public health emergency declared under [PHSA] section 319.”22 Subpart B—Mitigating Emergency Drug Shortages Background Drug shortages have remained a serious and persistent public health concern, despite the prevention and mitigation efforts of Congress, FDA, and the private sector. Causes of drug shortages include manufacturing and quality issues, lack of transparency in the supply chain, and business decisions made by individual firms (e.g., low profit margins leading to market exit).23 The Federal Food Drug and Cosmetic Act (FFDCA) and FDA regulations require manufacturers of certain drugs to submit to FDA specified information related to product shortages. In addition, the FFDCA and FDA regulations allow FDA to take action to mitigate or prevent shortages and require FDA to make public certain information about drug shortages. More specifically, FFDCA Section 506C(a) requires that the manufacturer of a drug that is life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition notify the Secretary (FDA by delegation of authority) of any permanent discontinuance or interruption in the manufacture of the drug that is likely to disrupt its U.S. supply.24 The notification must include the reasons for the interruption or discontinuance. FFDCA Section 506C(g) allows FDA, based on notifications received pursuant to Section 506C(a), to expedite facility inspections and review of supplements to new drug applications (NDAs), abbreviated NDAs (ANDAs), and supplements to ANDAs that could help mitigate or prevent a drug shortage.25 FFDCA Section 506E requires FDA to maintain a public, up-to-date list of drugs that are in shortage. The list must include the name of the drug in shortage, the name of the manufacturer, and, as determined by FDA, the estimated duration of and reason for the shortage.26 Persons that engage in the “manufacture, preparation, propagation, compounding or processing” of a drug must register their facility with FDA.27 FFDCA Section 510(j) requires that at the time of registration, such persons must file a list of all drugs being “manufactured, prepared, propagated, compounded or processed” for commercial distribution.28 Facilities registered with FDA are subject to inspection by the agency. FFDCA Section 704(b) requires that after a facility has been inspected, the inspector must provide a report, in writing, to 22 Of note, the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (the first supplemental appropriation for the COVID-19 response), P.L. 116-123, and the Coronavirus Aid, Relief, and Economic Security Act (CARES Act, P.L. 116-136) authorized the HHS Secretary to transfer unspecified amounts of appropriated funds to the Covered Countermeasure Process Fund. 23 FDA, “Drug Shortages: Root Causes and Potential Solutions,” published October 2019 and updated February 21, 2020, https://www.fda.gov/media/131130/download. 24 21 U.S.C. §356c(a). 25 21 U.S.C. §356c(g). 26 21 U.S.C. §356e. 27 21 U.S.C. §360. 28 21 U.S.C. §360(j). Congressional Research Service 10 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) the person in charge of that facility detailing the observations that led the inspector to determine that a product made in that facility may be adulterated. A copy of this report also must be sent to FDA.29 Section 3111. Prioritize Reviews of Drug Applications; Incentives Section 3111 amends FFDCA Section 506C(g) to require—rather than allow as was the case prior to the CARES Act—FDA to prioritize and expedite—rather than expedite as prior to CARES— facility inspections and review of ANDAs and supplements to NDAs and ANDAs that could help mitigate or prevent a drug shortage. Section 3112. Additional Manufacturer Reporting Requirements in Response to Drug Shortages Section 3112(a) amends FFDCA Section 506C(a) to extend notification requirements to the manufacturer of any drug “that is critical to the public health during a public health emergency declared by the Secretary” under PHSA Section 319. It also requires a manufacturer to notify FDA of any permanent discontinuance or interruption in the manufacture of an API—not just the finished drug—that is likely to lead to a meaningful disruption in the supply of the API of such drug. The notification must include, in addition to the reasons for the drug’s discontinuance or interruption, as applicable, information about the source of the API and alternative sources, as well as whether any associated device used in the preparation or administration of the drug has contributed to the shortage, among other information. Section 3112(b) amends FFDCA Section 506C to add a new subsection (j). New FFDCA Section 506C(j) requires the manufacturer of a drug, API, or associated medical device subject to the notification requirements under FFDCA Section 506C(a), as amended, to develop, maintain, and implement a redundancy risk management plan, as appropriate. Such plan should identify and evaluate risks to the supply of the drug, as applicable, for each facility in which the drug or API is manufactured. The plan is subject to inspection and copying by the Secretary. Section 3112 (c) amends FFDCA Section 506E to require the Secretary, not later than 180 days after enactment and every 90 days thereafter, to transmit to the Centers for Medicare & Medicaid Services (CMS) a report regarding the drugs on the current drug shortage list. Section 3112 (d) amends FFDCA Section 704(b) to require that following the inspection of a facility manufacturing a drug at risk of shortage or with limited competition, a copy of the inspection report be sent “promptly” to all appropriate FDA offices with expertise in drug shortages. Specifically, this requirement applies to the inspection of a facility manufacturing a drug—approved under an NDA or ANDA—for which a notification has been submitted under FFDCA Section 506C(a) (regarding an interruption in manufacturing or discontinuance), a drug that has been on the shortage list under FFDCA Section 506E in the past five years, or a drug with no blocking patents or exclusivities for which there are not more than three approved drugs listed in the Orange Book.30 Section 3112(e) amends FFDCA Section 510(j) to require each drug manufacturer that registers with FDA to report annually to the Secretary for each listed drug “the amount that was 29 21 U.S.C. §374(b). 30 The Orange Book satisfies the statutory requirement that FDA make publicly available, and revise every 30 days, a list of drugs that have been approved for safety and effectiveness and any patent information submitted with respect to such drugs. It also lists any unexpired periods of exclusivity covering an approved drug, in addition to other information applicants may find helpful. Congressional Research Service 11 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.” The Secretary may require this information to be submitted in electronic format, may require that this information be submitted at the time a public health emergency is declared under PHSA Section 319, and may exempt certain biologics from these reporting requirements if the Secretary determines it is not necessary to protect the public health. Subpart C—Preventing Medical Device Shortages Section 3121. Discontinuance or Interruption in the Production of Medical Devices Background FDA regulates the safety and effectiveness of medical devices in the United States. All medical device manufacturers are required to register their establishments with FDA,31 and such establishments are subject to inspections by FDA personnel or representatives. In addition, most medical devices are required to be reviewed by the agency prior to marketing; such premarket review mechanisms include premarket notification (510(k)),32 premarket approval,33 de novo classification request,34 and humanitarian device exemption,35 among others. Prior to the COVID-19 outbreak, concerns arose about potential medical device shortages due to the closure of ethylene oxide sterilization facilities that were not in compliance with U.S. Environmental Protection Agency (EPA) standards.36 In contrast to the agency’s authority to compel manufacturers of certain drugs to report discontinuances or interruptions in production,37 FDA did not have such authority for medical devices prior to the CARES Act. Rather, FDA relied on manufacturers to voluntarily report such information to the agency. In its FY2021 Congressional Justification, FDA requested additional authority to “require firms to notify FDA of an anticipated significant interruption in the supply of an essential device; require all manufacturers of devices determined to be essential to periodically provide FDA with information about the manufacturing capacity of the essential device(s) they manufacture; and authorize the temporary importation of devices whose risks presented when patients and healthcare providers lack access to critically important medical devices outweigh compliance with U.S. regulatory standards.”38 Legislation introduced in the 116th Congress would provide FDA with additional authority to mitigate potential device shortages, generally through adding required reporting requirements on device manufacturers and allowing for expedited premarket review and inspections in certain 31 21 U.S.C. §360; 21 C.F.R. Part 807. 32 21 U.S.C. §360(k); 21 C.F.R. Part 807. 33 21 U.S.C. §360e; 21 C.F.R. Part 814. 34 21 U.S.C. §360c(f)(2). 35 21 U.S.C. §360j(m). 36 FDA, “Statement on concerns with medical device availability due to certain sterilization facility closures,” October 25, 2019, https://www.fda.gov/news-events/press-announcements/statement-concerns-medical-device-availability-duecertain-sterilization-facility-closures. 37 21 U.S.C. §356c. 38 FDA FY2021 Justification of Estimates for Appropriations Committees, p. 36. Congressional Research Service 12 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) cases of shortage.39 However, some bills propose providing FDA with more authority than others, such as those allowing for importation of unapproved devices in the case of a device shortage.40 Provision Section 3121 creates a new FFDCA Section 506J, which requires medical device manufacturers to report to FDA during or prior to a public health emergency41 any permanent discontinuance of production, or interruption in production, likely to lead to a meaningful disruption in supply of a medical device, including the reasons for the discontinuance or interruption. Medical device manufacturers are required to report this information to FDA at least six months prior to occurrence, or as soon as is practical. In turn, FDA is required to make such information public to appropriate organizations (e.g., physicians, supply chain partners) unless such a disclosure would adversely affect the public’s health. If a manufacturer fails to submit information about discontinuances or interruptions, FDA is required to submit a letter to the manufacturer documenting this failure. The manufacturer is required to respond with reasons for noncompliance, as well as with information on interruptions or discontinuances as originally required, within 30 days. FDA would make such information public within 45 days of receipt but is not able to disclose to the public any information considered confidential or a trade secret. New FFDCA Section 506J also requires FDA to establish and maintain a device shortage list that includes, among other things, the category or name of the device in shortage and, as determined by FDA, the reason(s) for the shortage (e.g., demand increase for the device) and the expected duration of the shortage. Such information must be made public, except if such information is considered confidential, a trade secret, or determined by FDA to be harmful to the public’s health (e.g., increases the possibility of hoarding). Finally, new FFDCA Section 506J requires FDA to expedite premarket review and facility inspections of medical devices considered to be, or likely to be, in shortage and defines the terms “meaningful disruption” and “shortage.” Part II—Access to Health Care for COVID-19 Patients Subpart A—Coverage of Testing and Preventive Services This subpart includes three provisions related to coverage of COVID-19 tests and subsequent vaccines that may be developed to prevent COVID-19. They primarily address private health insurance coverage, including insurer payments to providers who furnish the test. One provision expands the FFCRA definition of testing that must be covered without cost-sharing by most private health insurance plans, and by other public and private health coverage programs and plans that reference the FFCRA definition. Section 3201. Coverage of Diagnostic Testing for COVID-19 Background Through multiple provisions in Divisions A and F, FFCRA provides payment for or requires coverage of testing for the COVID-19 virus, and items and services associated with such testing, 39 See for example, S. 3468 (116th Congress); S. 3343 (116th Congress); H.R. 6049 (116th Congress); H.R. 6062 (116th Congress). 40 H.R. 6062 (116th Congress). 41 See ““Section 319” Public Health Emergency”. Congressional Research Service 13 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) without any cost-sharing. 42 Several of these provisions refer to a definition for COVID-19 testing established in FFCRA Section 6001(a)(1), which defines such tests to include in vitro diagnostics (IVDs), as defined in FDA regulation, that detect the SARS-CoV-2 virus43 or diagnose COVID19 and that have received either 510(k) clearance, premarket approval, authorization pursuant to de novo classification, or emergency use authorization (EUA) for marketing. This definition is used or cross-referenced in the following provisions providing payment for or requiring coverage of testing for the COVID-19 virus: (1) Section 6001(a)(1)-(2), with respect to specified types of private health insurance coverage; (2) Section 6006, with respect to TRICARE, veterans’ health care, and federal civilian employee health coverage (Federal Employees Health Benefits Program or FEHBP); and (3) Section 6007, with respect to the Indian Health Service (IHS). In addition, appropriations provided in FFCRA Division A to the Defense Health Program, Veterans Health Administrations, IHS, and Public Health and Social Services Emergency Fund are to be used, in whole or in part, to pay for COVID-19 testing and related services, with reference to FFRCA Section 6001(a)(1). On March 16, 2020, FDA updated guidance relating to COVID-19 diagnostic tests during the public health emergency.44 In this guidance, the agency detailed four policies, whereby manufacturers or laboratories could develop, use, or market laboratory-developed tests or test kits for COVID-19. Two of these policies allowed for laboratories and test kit manufacturers to begin using or distributing their tests prior to receiving an EUA from the agency, as long as they submitted an EUA application within 15 business days of beginning clinical testing or distribution of the test kit and notified the agency that the test was in use. Therefore, tests and test kits would be in clinical use without having been granted an EUA (or 510(k) clearance, de novo authorization, or premarket approval). In addition, the agency outlined a policy allowing states to authorize laboratories within their state to carry out testing without FDA involvement; therefore, these tests would also be in clinical use without authorization from the FDA (or 510(k) clearance, de novo authorization, or premarket approval). Therefore, pursuant to the FDA’s updated March 16 guidance, some tests in clinical use would fall outside the definition at FFCRA Section 6001(a)(1) and may not be included in the above-referenced provisions’ requirements providing payment for or requiring coverage of testing for the COVID-19 virus. Provision Section 3201 amended FFCRA Section 6001(a)(1) to include those IVDs (1) that have received either 510(k) clearance, premarket approval, authorization pursuant to de novo classification, or an EUA; (2) where the developer has requested, or intends to request, an EUA; (3) that are developed in and authorized by a state that has notified the Secretary of its intention to review tests intended to diagnose COVID–19; and (4) that are determined appropriate through guidance by the Secretary. Section 3202. Pricing of Diagnostic Testing Background 42 CRS Report R46316, Health Care Provisions in the Families First Coronavirus Response Act, P.L. 116-127. 43 SARS-CoV-2 is the technical name of the virus that causes COVID-19 disease. 44 FDA, “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency,” March 16, 2020, https://www.fda.gov/media/135659/download. Congressional Research Service 14 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) FFCRA Section 6001 created a requirement for most private health insurance plans to cover specified COVID-19 testing and testing-related items and services.45 The coverage must be provided without consumer cost-sharing, including deductibles, copayments, or coinsurance. This coverage requirement applies to the specified items and services that are furnished during the COVID-19 public health emergency described in FFCRA.46 The provision did not address the reimbursement amount that a provider must receive from a health plan for furnishing COVID-19 testing. In private health insurance, the amount paid for covered items and services is generally contingent upon whether a consumer’s health plan has negotiated with a provider to enter into a contract.47 The contract between the health plan and the provider generally specifies the total amount that a provider may receive for furnishing particular items or services to that health plan’s enrollees. A provider that enters into a contract with a health plan is considered to be part of the health plan’s network, otherwise referred to as being in-network. A provider that does not enter into a contract with a health plan is considered out-of-network and as such there is no negotiated rate between the provider and the health plan. In situations involving services provided by an out-of-network provider, the amount that a provider will receive from a health plan depends on whether the health plan covers out-of-network services. In situations where health plans do not cover out-of-network services, the health plan will not pay any amount to a provider for services provided to an enrollee of the health plan. In situations where plans do cover out-of-network services, as there is no negotiated rate between health plans and out-of-network providers, health plans will use their own methodologies for calculating how much they will pay out-of-network providers for services. Provision Section 3202 establishes a methodology for determining the amount that a health plan must reimburse a provider for the COVID-19 testing, and testing-related items and services that are required to be covered under FFCRA Section 6001(as amended).48 If a health plan had a negotiated rate with a provider prior to the declaration of the COVID-19 public health emergency declared under PHSA Section 319, then the health plan must apply that negotiated rate throughout the period of the COVID-19 public health emergency.49 If a health plan did not have a negotiated rate with a provider prior to the emergency declaration, then the health plan must either reimburse the provider an amount that equals the cash price for the COVID-19 testing, as listed on the provider’s public website, or the health plan and provider may negotiate a rate that is less than the cash price. During the period of the COVID-19 public health emergency, providers of COVID-19 diagnostic testing must make public the cash price for the COVID-19 test on the provider’s public website. For information on the types of plans subject to the coverage requirement and this payment requirement, see “See Section 6001. Coverage of Testing for COVID-19” in CRS Report R46316, Health Care Provisions in the Families First Coronavirus Response Act, P.L. 116-127. The definition of covered testing and related services in FFCRA Sec. 6001 was amended by the CARES Act. See “Section 3201. Coverage of Diagnostic Testing for COVID-19.” 46 See ““Section 319” Public Health Emergency”. 47 For an overview of private health insurance billing, see the section “Private Health Insurance Billing Overview” in CRS Report R46116, Surprise Billing in Private Health Insurance: Overview and Federal Policy Considerations. 48 See footnote 44. 49 See ““Section 319” Public Health Emergency”. 45 Congressional Research Service 15 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) The Secretary may impose a civil monetary penalty on a provider of COVID-19 diagnostic testing that is not in compliance with the requirement to post the cash price for the COVID-19 testing and has not completed a corrective action plan to comply with the requirement. The amount of the civil monetary penalty may not exceed $300 per day that the violation is ongoing. Section 3203. Rapid Coverage of Preventive Services and Vaccines for Coronavirus Background PHSA Section 2713 and accompanying regulations50 require most private health insurance plans to cover, without cost-sharing,51 specified types of clinical preventive services. These include any preventive service recommended with an A or B rating by the United States Preventive Services Task Force (USPSTF),52 or any immunization with a recommendation by the Advisory Committee on Immunization Practices (ACIP),53 adopted by CDC, for routine use for a given individual. These coverage requirements apply no sooner than one year after a recommendation is published.54 Requirements of Section 2713 apply to individual health insurance coverage and to small- and large-group plans, whether fully insured or self-insured.55 The requirements do not apply to grandfathered individual or group plans, or to short-term, limited duration insurance (STLDI).56 By regulation, plans are generally not required to cover preventive services furnished out-ofnetwork. Cost-sharing for office visits associated with a furnished preventive service may or may not be allowed, as specified in regulation.57 Provision Section 3203 requires specified plans—the same types of plans as those subject to PHSA Section 2713—to cover a COVID-19 vaccine and potentially other COVID-19 preventive services, as recommended by ACIP or USPSTF, respectively.58 This coverage must be provided without costsharing. Section 3203 also applies an expedited effective date for coverage of 15 business days 50 Section 2713 was added to the Public Health Service (PHSA) and incorporated into the Employee Retirement Income Security Act (ERISA) and Internal Revenue Code (IRC) by the Patient Protection and Affordable Care Act (ACA, P.L. 111-148, as amended). Regulations are at 29 C.F.R. 2590.715-2713, 26 C.F.R. 54.9815-2713, and 45 C.F.R. 147.130. 51 In general, private health insurance cost-sharing includes deductibles, coinsurance, and copayments. A deductible is the amount an insured consumer pays for covered health care services before coverage begins (with exceptions, such as the preventive services specified in this provision). Coinsurance is the share of costs, figured in percentage form, an insured consumer pays for a health service. Co-payment is the fixed dollar amount an insured consumer pays for a health service. 52 U.S. Preventive Services Task Force (USPSTF), https://uspreventiveservicestaskforce.org/uspstf/. 53 Advisory Committee on Immunization Practices (ACIP), https://www.cdc.gov/vaccines/acip/index.html. 54 Per 45 C.F.R. 147.130(b), such coverage is required “for plan years (in the individual market, policy years) that begin on or after the date that is one year after the date the recommendation or guideline is issued.” 55 For more information about types of private health insurance plans, see CRS Report R45146, Federal Requirements on Private Health Insurance Plans. 56 For more information about grandfathered plans and short-term, limited duration insurance (STLDI), see CRS Report R46003, Applicability of Federal Requirements to Selected Health Coverage Arrangements. 57 In general, whether cost-sharing for office visits is allowed or prohibited depends on whether the preventive service or item was the primary purpose of the visit, and whether the service or item was billed or tracked separately from the office visit. See 45 C.F.R. 147.130(a)(2). 58 Cares Act Section 3203 refers to, but does not amend, PHSA Section 2713. Congressional Research Service 16 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) after an applicable ACIP or USPSTF recommendation is published. Otherwise, requirements of Section 3203 mirror existing requirements under PHSA Section 2713. Subpart B—Support for Health Care Providers This subpart includes provisions that aim to extend the services available during the COVID-19 period and beyond, particularly for rural or otherwise underserved populations. The subpart includes additional appropriations for health centers that provide care to populations that are underserved or are located in underserved areas. Other provisions relate directly to health care providers; for example, by conferring medical malpractice liability on health professionals who choose to volunteer during the emergency period, by amending program rules for the NHSC program to permit individuals to volunteer during the emergency period, and by clarifying aspects of the USPHS Ready Reserve Corps program. The Ready Reserve Corps is composed of reserve officers serving in other roles who would be subject to intermittent involuntary deployment (“call up”) to bolster the available workforce for public health emergency missions. Finally, the subpart reauthorizes and amends existing programs related to supporting rural health care providers and encouraging the use of telehealth to expand access to care. Section 3211. Supplemental Awards for Health Centers Background The federal health center program, authorized by PHSA Section 330 and administered by the Health Resources and Services Administration (HRSA), provides grants to not-for-profit organizations or state and local government entities to operate outpatient health centers. Participation in the program requires grantees to provide care regardless of a patient’s ability to pay, and grant funding is provided to support this care. These centers are also required to be located in medically underserved areas (MUAs) or to provide care to a population that is designated as underserved.59 Health centers are part of the health care safety net, and they have been used as a way to fund safety net providers during prior disasters, when additional funds were appropriated to make awards to existing grantees to respond to an emerging need.60 In FY2020, health centers received a combination of discretionary and mandatory funding, which together provided more than $5.6 billion to support the program.61 Health centers also received additional funds in P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, the first law to respond to COVID-19. That law provided the program with an additional $100 million. These funds were awarded via formula to supplement existing health center funding.62 59 For more information about these designations, see CRS Report R43937, Federal Health Centers: An Overview. 60 For example, health centers received additional funding to respond to the Zika virus outbreak. See Table 1 in CRS Report R44460, Zika Response Funding: Request and Congressional Action. 61 For FY2019 and FY2020 funding amounts, see HHS, HRSA, “Justification of Estimates for Congressional Committees, FY2021,” https://www.hrsa.gov/sites/default/files/hrsa/about/budget/budget-justification-fy2021.pdf, pp. 17. 62 HHS, HRSA, “HHS Awards $100 Million to Health Centers for COVID-19 Response,” press release, March 24, 2020, https://www.hhs.gov/about/news/2020/03/24/hhs-awards-100-million-to-health-centers-for-covid-19response.html. Congressional Research Service 17 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) Provision This section appropriates $1.32 billion in supplemental funding for health centers for FY2020 for the detection of the COVID-19 virus, or prevention, diagnosis, and treatment of COVID-19 illnesses. The section also applies the limits on using these funds for abortion that were included in Further Consolidated Appropriations Act, 2020 (P.L. 116-94), which provided FY2020 appropriations for HHS, among other agencies.63 Section 3212. Telehealth Network and Telehealth Resource Centers Grant Programs Background PHSA Section 333(I) authorizes two telehealth programs that were authorized at “such sums as may be necessary” through FY2006. Both programs have been funded since that time, despite the lapsed authorization of appropriation. The programs are administered by HRSA. The first program, authorized in PHSA Section 333I(d)(1), is the Telehealth Network Grant Program (TNGP). This program aims to demonstrate how telehealth technologies can be used through telehealth networks for medically underserved populations who live in rural areas, frontier communities, and MUAs.64 Prior to passage of the CARES Act, only nonprofit entities were eligible to apply for TNGP grants; however, prior law permitted both nonprofit and for-profit organizations to participate in the grantees’ telehealth networks. The second program is the Telehealth Resource Centers (TRC) Program. This program aims to coordinate telehealth organizations that serve rural and underserved communities throughout the country, by providing technical assistance to those organizations through national and regional TRCs.65 FY2020 appropriations report language provides $28.5 million to HRSA’s overarching Telehealth Program, which includes both of these programs.66 Provision This section amends PHSA Section 330I to make changes to both the TNGP and the TRC programs. It makes the following changes: (1) The Telehealth Network Grant Program (TNGP) Grants. Section 3212 amends PHSA Section 330I by replacing the HRSA Administrator’s Director’s authority to award grants to eligible grantees to demonstrate how telehealth technologies can be used through telehealth networks, with the authority to award grants to evidence-based projects that utilize telehealth technologies through telehealth networks. The purpose of the TNGP now includes improving access to and quality of health care services for the TNGP patient population. Grantees may no longer use TNGP funds to expand health care provider training or for decision-making purposes. 63 Under federal law, federal funds are generally not available to pay for abortions, except in cases of rape, incest, or endangerment of a mother’s life. This restriction is the result of statutory and legislative provisions like the Hyde Amendment, which has been added to the annual appropriations measure for HHS since 1976. 64 42 U.S.C. §254c-14(d)(1). 65 42 U.S.C. §254c-14(d)(2); and CRS Report R46289, The National Consortium of Telehealth Resource Centers: COVID-19 Assistance. 66 H.Rept. 116-62, p. 327. To learn about HRSA’s other telehealth programs, see HRSA, FY2021 Justification of Estimates for Appropriations Committees, pp. 324-328, https://www.hrsa.gov/sites/default/files/hrsa/about/budget/ budget-justification-fy2021.pdf. Congressional Research Service 18 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) Grant period. Section 3212 allows the HRSA Administrator to extend the period of performance for the TNGP from four years to five years. This section also makes administrative changes to the statutory requirements on telehealth networks, including the nature of entities and composition of telehealth networks. This section removes the statutory requirements that grantees of TNGP be nonprofit entities and that telehealth networks be composed in a certain manner. Applications. Grant applicants are now required to describe within their applications how the applicants’ proposed TNGP projects will, among other things, improve access and quality of the health care services that patients will receive. Prior to passage of the CARES Act, this provision was optional. Terms, conditions, maximum amount of assistance. Section 3212 removes the statutory requirements that the Secretary has to establish the terms and conditions of the TNGP, as well as the maximum amounts awarded to each TNGP recipient for each fiscal year. This section removes the federal mandate that required the Secretary to publish, through HRSA, a notice of application requirements for the TNGP program for each fiscal year. Preferences. The Secretary is required to also give preference to eligible entities that develop plans for or establish telehealth networks that provide mental health care services, public health care services, long-term care, home care, preventive care, case management services, or prenatal care for high-risk pregnancies. This section also expands preference to eligible entities that propose projects that promote local and regional connectivity within areas, communities, and populations served. The Secretary, however, may no longer give preference to applicants that demonstrate integration of health care information into TNGP projects. Distribution of funds. The HRSA Administrator no longer has to ensure that the total amount of funds awarded in a given fiscal year is not less than the total amount awarded for projects in FY2001. The HRSA Administrator must continue to ensure that no less than 50% of funds are awarded to TNGP projects in rural areas. Use of funds. Grantees no longer have the authority to use TNGP funds to purchase certain equipment. Grantees are prohibited from purchasing computer hardware and software, audio and video equipment, computer network equipment, interactive equipment, and data terminal equipment. However, grantees may continue to purchase equipment that furthers the objectives of the TNGP, such as to expand access to health care services. Prohibited uses of funds. TNGP grantees are prohibited from using more than 20% of total grant funds to purchase or lease equipment. Under prior law, grantees were allowed to use no more than 40% of total grant funds. Section 3212 also removes the examples of transmission equipment from the list of items that TNGP funds cannot be used to purchase. Report and regulations. The section requires the Secretary to submit a report, to specified congressional committees, that describes the activities and outcomes of the TNGP, no later than March 27, 2024, and every five years thereafter. The Secretary is no longer required to issue regulations specifying the definition of frontier area. (2) The Telehealth Resource Centers (TRC) Program Grants and eligibility. Section 3212 amends PHSA Section 330I by replacing the HRSA Administrator’s authority to award grants for projects to demonstrate how telehealth technologies can be used in certain areas and communities, with the authority to award grants to support initiatives that utilize telehealth technologies. The CARES Act removes the program’s authority to establish new TRCs, which essentially makes the current TRCs permanent recipients of federal funds under the program and does not allow for other entities to participate as TRCs. The section also permits the HRSA Administrator to extend the period of performance for the TRC program Congressional Research Service 19 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) from four years to five years. Section 3212 removes the statutory requirement that grantees of the TRC program be nonprofit entities. Terms, conditions, maximum amount of assistance. Section 3212 removes the statutory requirement that the Secretary has to establish the terms and conditions of the TRC program, as well as the maximum amount awarded to each TRC program recipient for each fiscal year. This section no longer requires the Secretary to publish, through HRSA, a notice of application requirements for the TRC program for each fiscal year. Preferences. The section requires the Secretary to also give preference to eligible entities with successful records in delivering health care services to rural areas, MUAs, and medically underserved populations. Use of funds. The section specifies that grantees no longer have the authority to use TRC program funds to foster certain telehealth activities. It also prohibits grantees from using funds to foster the use of telehealth technologies to provide health care information. However, grantees may continue to foster the use of telehealth technologies to educate health care providers and consumers in an effective manner. Report and regulations. The section requires the Secretary to submit a report, to specified congressional committees, on the activities and outcomes of the TRC program, no later than March 27, 2024, and every five years thereafter. (This report need not to be a separate report from that required of the TNGP.) The Secretary is no longer required to issue regulations specifying the definition of frontier area. Authorization of appropriations. The section authorizes an appropriation of $29 million for each of FY2021 through FY2025. Section 3213. Rural Health Care Services Outreach, Rural Health Network Development, and Small Health Care Provider Quality Improvement Grant Programs Background PHSA Section 330A authorizes three grant programs supporting rural health care providers: the rural health care services outreach grants, the rural health network development grants, and the small health care provider quality improvement grants. These programs are administered by HRSA’s Federal Office of Rural Health Policy (FORHP).67 In each case, grants are available to nonprofit or governmental health entities for a period of three years. The Rural Health Network Development program also permits additional one-year planning grants. Funds for the program had been authorized at $45 million annually through FY2012, and required a one-time report to Congress that was required at the end of FY2005. Despite the lapsed authorizations of appropriations, these programs have continued to be funded in recent years. Most recently, the programs received an appropriation of $79.5 million in FY2020.68 Provision This section makes a number of technical corrections to PHSA Section 330A. It also replaces language related to essential health services to make reference to basic health services, extends the duration of Rural Health Care Service Outreach grants and Rural Health Network 67 HHS, HRSA, “Rural Community Programs,” https://www.hrsa.gov/rural-health/community/index.html. 68 HHS, HRSA “Justification of Estimates for Congressional Committees, FY2021,” https://www.hrsa.gov/sites/ default/files/hrsa/about/budget/budget-justification-fy2021.pdf, p. 20. Congressional Research Service 20 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) Development grants from three to five years, and expands eligibility for the programs to any rural health entity (prior eligibility was limited to rural public or nonprofit health entities). The section also eliminates the one-year planning grants from the Rural Health Network Development program and extends the grant period of the Small Health Care Quality Improvement grants from three to five years. Finally, the section requires a report, to be delivered to specified congressional committees, on these grant programs, not later than four years after enactment and every five years thereafter, and authorizes an appropriation of $79.5 million for each of FY2020 through FY2025. No additional funding for FY2020 is appropriated in this provision. Section 3214. United States Public Health Service Modernization Background The USPHS Commissioned Corps is a branch of the U.S. uniformed services, but it is not one of the armed services.69 The Corps is based in HHS under the authority of the U.S. Surgeon General (SG). USPHS-commissioned officers are physicians, nurses, pharmacists, engineers, and other public health professionals who serve in federal agencies, or as detailees to state or international agencies, to support a variety of public health activities. ACA (the Patient Protection and Affordable Care Act, P.L. 111-148, as amended), Section 5210, authorized a USPHS Ready Reserve Corps—reserve officers serving in other roles who would be subject to intermittent involuntary deployment (“call up”) to bolster the available workforce public health emergency missions.70 HHS had not received an appropriation for this purpose and had not established a Ready Reserve Corps. It has been reported that the ACA authority did not fully authorize this action, and legislation (S. 2629, the United States Public Health Service Modernization Act of 2019) was introduced to address this.71 Provision Section 3214 enacts the language of S. 2629, making several technical and substantive amendments to PHSA Title II to clarify provisions regarding deployment readiness, retirement, compensation, and other matters as they would affect the Ready Reserve Corps.72 Section 3215. Limitation on Liability for Volunteer Health Care Professionals During COVID-19 Emergency Response Background In 1997, Congress enacted the Volunteer Protection Act of 1997 (VPA; P.L. 105-19).73 This act provides that a volunteer at a nonprofit organization or governmental entity is not liable for the 69 10 U.S.C. §101. The Commissioned Corps of the U.S. Public Health Service is authorized in PHSA Secs. 201-224 (42 U.S.C. §§202-233). For more information see HHS, USPHS Commissioned Corps, http://www.usphs.gov/ default.aspx. 70 See “Sec. 5210. USPHS Ready Reserve Corps” in CRS Report R41278, Public Health, Workforce, Quality, and Related Provisions in ACA: Summary and Timeline. 71 Scott Maucione, “Public Health Service Gets Congressional Attention for Ready Reserve Corps,” Federal News Network, November 4, 2019, https://federalnewsnetwork.com/workforce/2019/11/public-health-service-getscongressional-attention-for-ready-reserve-corps/. 72 In addition, the CARES Act provides about $27 billion in emergency supplemental appropriations to the HHS Secretary, through the Public Health and Social Services Emergency Fund, for numerous stated purposes, including “enhancements to the U.S. Commissioned Corps.” 73 Codified at 42 U.S.C. §§ 14501-14505. Congressional Research Service 21 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) harm he or she causes by an act (or an act of omission) on behalf of the organization, provided the following: (1) the volunteer was, among other things, properly licensed, certified, or authorized for the activities in a state, if applicable; (2) the volunteer was acting within the scope of his or her responsibilities in the organization at the time of the act (or act of omission); and (3) the harm was not caused by “willful or criminal misconduct, gross negligence, reckless misconduct, or a conscious, flagrant indifference to the rights or safety of the individual harmed by the volunteer.”74 The law does not convey liability protections in certain instances (e.g., when misconduct is a criminal act or when the defendant acted under the influence of drugs or alcohol),75 and the law specifies how it interacts with relevant state law.76 This law was not specific to health professionals in a volunteer capacity but, rather, covered all types of volunteers. Provision This section limits the medical malpractice liability of health professionals who volunteer during the COVID-19 emergency. Specifically, it limits the liability under federal and state law for any harm caused by an act or omission while providing health services during the emergency, provided that the health services are within the scope of the health professional’s license registration, or certification, and that the health professional acted in good faith. The section specifies that health professionals do not have liability protections in situations where harm was caused by “willful or criminal misconduct, gross negligence, reckless misconduct, or a conscious flagrant indifference to the rights or safety of the individual harmed by the health care professional,” or when services were provided by a health professional who was under the influence of drugs or alcohol. The section specifies that it preempts state or local laws that are inconsistent with this section, unless those laws provide great liability protections, and specifies that the liability protections are in addition to those provided under the VPA. Finally, the section defines relevant terms and specifies that this provision is effective at enactment and will remain in effect for the length of the public health emergency declared by the Secretary under PHSA Section 319, declared by the Secretary on January 30, 2020. Section 3216. Flexibility for Members of National Health Service Corps During Emergency Period Background The federal government supports a number of health workforce programs administered by HRSA. Among the largest of these programs is the NHSC, which provides scholarships and loan repayment to health care providers in exchange for a two-year or more service commitment in a health professional shortage area (HPSA).77 The program is authorized in PHSA Sections 332338I. PHSA Section 333 specifies the types of health care facilities and the conditions they must meet to receive NHSC personnel. Generally, these are outpatient health facilities in HPSAs.78 74 Id. §14503(a). 75 Id. §14503(g). 76 Id. §14502(a) (preempting state laws to the extent of inconsistency with the Volunteer Protection Act (VPA), but not preempting state laws that provide greater liability protections for volunteers). 77 CRS Report R44970, The National Health Service Corps. For more information about health professional shortage areas (HPSAs), see CRS Infographic IG10015, Health Professional Shortage Areas (HPSAs). 78 Certain inpatient facilities are permitted, such as critical access hospitals and Indian Health Service (IHS) facilities. Congressional Research Service 22 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) Provision This section specifies that for the duration of the public health emergency declared under PHSA Section 319 for the COVID-19 response, the Secretary may waive the requirements in PHSA Section 333 in order to assign NHSC members to voluntarily provide health services to respond to the emergency. The provision allows NHSC members to volunteer services for the number of hours that the Secretary determines appropriate. The provision further specifies that NHSC members must be assigned voluntarily, that the assignment site must be in reasonable proximity to the NHSC corps member’s original practice site, and that these hours are to count toward fulfilling their NHSC service commitment. Subpart C—Miscellaneous Provisions Section 3221. Confidentiality and Disclosure of Records Relating to Substance Use Disorder Background Generally, the privacy of health information is governed by the HIPAA (Health Insurance Portability and Accountability Act of 1996, P.L. 104-191, as amended) Privacy Rule, which establishes requirements for covered entities’ (health care plans, providers, and clearinghouses) and their business associates’ use and disclosure of protected health information (PHI). All health information is generally treated similarly under the HIPAA Privacy Rule, with certain exceptions in place relating to the use and disclosure of psychotherapy notes. In contrast, stricter federal privacy requirements at PHSA Section 543—requirements promulgated in and commonly known as the “Part 2” rule—apply to individually identifiable patient information received or acquired by federally assisted substance use disorder programs.79 Specifically, the Part 2 rule governs any information that would identify a patient as having or having had a substance use disorder, and that is obtained or maintained by a federally assisted substance use disorder program for the purpose of treating a substance use disorder, making a diagnosis for that treatment, or making a referral for that treatment.80 Part 2 requirements apply to an individual or entity (other than a general medical facility) that is federally assisted and provides—and holds itself out as providing—diagnosis, treatment, or referral for treatment of substance use disorders.81 “Federally assisted programs” include programs that are carried out in whole or in part by the federal government or supported by federal funds. The Part 2 rule strictly regulates the disclosure and redisclosure of patient identifying information held by Part 2 programs. The rule allows disclosure of this information only either (1) with written patient consent or (2) pursuant to exceptions in statute or regulation (e.g., for a medical emergency, for research). A general authorization for the release of medical information does not satisfy the rule’s requirement for written consent, although a general designation in consent is allowed in cases where a class of participants may receive and redisclose amongst themselves Part 2 information if there exists a treatment relationship.82 Further, the rule strictly prohibits the subsequent redisclosure of information received from a Part 2 program without consent from the patient, and a notification clearly prohibiting this redisclosure by the receiving entity travels with 79 42 U.S.C. §290dd-2; 42 C.F.R. Part 2. 80 42 C.F.R. §2.12(a). 81 42 C.F.R. §2.12(b). 82 42 C.F.R. §2.31(a)(4)(iii)(3). Congressional Research Service 23 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) any disclosed Part 2 information. Under PHSA Section 543(f), any person who violates any provision of the section or any regulation issued pursuant to the section shall be fined in accordance with Title 18 of the U.S. Code.83 Provision Section 3221 amends PHSA Section 543 to allow for, pursuant to written consent, the use or disclosure of covered records by a covered entity, business associate, or a Part 2 program for purposes of treatment, payment, and health care operations as permitted by the HIPAA Privacy Rule. In addition, the section allows information disclosed pursuant to this exception to be subsequently redisclosed in accordance with the HIPAA Privacy Rule. It further allows the disclosure of deidentified records to public health authorities, without written consent, if the information meets the deidentification standards in the HIPAA Privacy Rule.84 Section 3221 applies the penalties under SSA Sections 1176 and 1177 for violations of PHSA Section 543, as specified. It also prohibits discrimination against an individual on the basis of information received pursuant to an inadvertent or intentional disclosure of covered records, or information contained in covered records, in multiple instances (e.g., employment, access to courts). The section applies the HIPAA breach notification requirements to a program or activity under PHSA Section 543 in case of a breach of records.85 Section 3221 requires the Secretary to revise regulations as necessary such that changes in the section apply with respect to uses and disclosures of covered records occurring on or after the date that is 12 months after enactment. It also requires the Secretary, not later than one year after enactment and in consultation with appropriate legal, clinical, privacy, and civil rights experts, to update the notice of privacy practices requirement in the HIPAA Privacy Rule86 to require covered entities and entities creating or maintaining covered records to provide notice, in plain language, of privacy practices regarding those records. The section also establishes that nothing in the act shall be construed to limit (1) the right of an individual to request a restriction on the use or disclosure of a record under PHSA Section 543 for purposes of treatment, payment, or health care operations, and (2) the choice of a covered entity to obtain consent to use or disclose a covered record for purposes of treatment, health care operations, or payment. Section 3222. Nutrition Services Background The OAA (Older Americans Act, P.L. 89-73, as amended; 42 U.S.C. §§ 3001 et seq.) Nutrition Services Program provides grants to states and U.S. territories under Title III of the act to support congregate nutrition services (i.e., meals served at group sites such as senior centers, community centers, schools, churches, and senior housing complexes) and home-delivered nutrition programs for individuals aged 60 and older.87 The Nutrition Services Program is designed to address problems of food insecurity, promote socialization, and promote the health and well-being of older persons through nutrition and nutrition-related services. The program is administered by the Administration for Community Living (ACL) under HHS. States and territories receive separate funding allotments for each program based on a statutory funding formula. Under OAA, states 83 42 U.S.C. §290dd-2(f). 84 45 C.F.R. §164.514(b). 85 45 C.F.R. 164 Part D. 86 45 C.F.R. §164.520. 87 For more information, see CRS In Focus IF10633, Older Americans Act: Nutrition Services Program. Congressional Research Service 24 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) and U.S. territories have authority to transfer up to 40% of their allotments between congregate and home-delivered nutrition services and can request waivers to transfer up to 10% of additional funding between these programs. In addition, OAA provides states authority to transfer up to 30% of program funding from the Supportive Services Program to the Nutrition Services Program.88 Nutrition services providers are required to offer at least one meal per day, five or more days per week (except in rural areas, where the provision of meals may be less frequent).89 The meals must comply with the Dietary Guidelines for Americans published by the Secretary of HHS and the Secretary of Agriculture. Providers must serve meals that meet specified minimum amounts for the daily recommended dietary reference intakes (DRIs) established by the Food and Nutrition Board of the National Academies of Sciences, Engineering, and Medicine based on the number of meals served by the project each day.90 With respect to home-delivered nutrition programs, individuals aged 60 or older and their spouses (regardless of age) may participate in the homedelivered nutrition program. Persons aged 60 or over who are frail, homebound by reason of illness or disability, or otherwise isolated, are also prioritized for OAA Title III services.91 Services may be available to individuals under age 60 with disabilities if they reside at home with the older individual.92 Service eligibility is determined by the states and local Area Agencies on Aging (AAA); however, according to the ACL, entities may waive any eligibility requirements they have established for home-delivered meals in response to the COVID-19 pandemic.93 Provision During any portion of the COVID-19 public health emergency declared under PHSA Section 319, the section sets forth additional transfer authority between OAA nutrition programs, clarifies participant requirements for home-delivered meals, and authorizes the Assistant Secretary for Aging to waive certain dietary requirements for nutrition services. Specifically, the HHS Secretary is required to allow a state agency or an AAA to transfer up to 100% of the funds appropriated and received for congregate and home-delivered nutrition between these two programs, for such use as the state or area considers appropriate to meet service needs without prior approval. For purposes of state agencies’ determining the delivery of nutrition services, the provision requires the same meaning to be given to individuals who are unable to obtain nutrition because they are practicing social distancing due to the emergency as is given to an individual who is homebound because of illness. And, to facilitate implementation of nutrition services programs, the Assistant Secretary is authorized to waive compliance with the Dietary Guidelines for Americans and the specified minimum amounts for the daily recommended DRI requirements. 88 On March 13, 2020, the President declared that the ongoing COVID-19 pandemic is of sufficient severity and magnitude to warrant an emergency determination under §501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (“Stafford Act”; 42 U.S.C. 5121-5207). The emergency exists nationwide. Under the declaration, states, U.S. territories, and tribes may consider requests for a declaration of a “major disaster” under Section 401(a) of the Stafford Act. A major disaster declaration under the Stafford Act triggers disaster relief authority in the Older Americans Act (OAA) should a state (including a U.S. territory) or tribe (OAA Title VI grantee) request and receive such declaration. Specifically, OAA Section 310 provides authority for states to use any portion of funding made available under any and all sections of the act for disaster relief provided to older individuals. For further information, see Agency for Community Living (ACL) guidance issued March 16, 2020, at https://acl.gov/sites/default/ files/common/OAADisasterRelief_2020-03-16.pdf. 89 42 U.S.C. §3030e-f. 90 42 U.S.C. §3030g-21. 91 45 C.F.R. §1321.69. 92 42 U.S.C. §3030g-21. 93 ACL, “Information for the Aging and Disability Networks, Grant and Program Guidance, Older Americans Act Programs,” https://acl.gov/COVID-19. Congressional Research Service 25 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) The provision defines the terms ‘‘Assistant Secretary,’’ ‘‘Secretary,’’ ‘‘State agency,’’ and ‘‘area agency on aging’’ to have the same meanings as under OAA Section 102. Section 3223. Continuity of Service and Opportunities for Participants in Community Service Activities Under Title V of the Older Americans Act Background OAA Title V establishes the Community Service Employment for Older Americans program (CSEOA), sometimes referred to as the Senior Community Service Employment Program (SCSEP). CSEOA promotes part-time employment opportunities in community service activities for unemployed low-income persons aged 55 and older and who have poor employment prospects.94 The Title V program is administered by the Department of Labor’s (DOL’s) Employment and Training Administration. DOL allocates Title V funds for grants based on a statutory funding formula to state agencies in all 50 states, the District of Columbia, Puerto Rico, and the U.S. territories, and to national organizations. Program participants work part-time in community service jobs, including employment at schools, libraries, social service organizations, and senior-serving organizations. Program participants earn the higher of minimum wage or the typical wage for the job in which they are employed. An individual may typically participate in the program for a cumulative total of no more than 48 months.95 Provision Due to the effects of the COVID-19 public health emergency declared under PHSA Section 319, this section specifies additional flexibility for the Secretary of Labor with respect to administration and implementation of the CSEOA program. Specifically, it authorizes the Secretary to allow individuals participating in OAA Title V projects as of March 1, 2020, to extend their participation for a period that exceeds 48 months in the aggregate, as determined by the Secretary. It authorizes the Secretary to increase the average participation cap for grantees of 27 months for eligible individuals to a cap the Secretary determines is appropriate. And it authorizes the Secretary to increase the amount available to pay the authorized administrative costs for a project, which is currently 13.5% of the grant amount, to not exceed 20% of the grant amount, if the Secretary determines that such increase is necessary to adequately respond to additional administrative needs. Section 3224. Guidance on Protected Health Information Background 94 For more information, see CRS Report R45626, Older Americans Act: Senior Community Service Employment Program. 95 42 U.S.C. §3056. Congressional Research Service 26 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) The HIPAA Privacy Rule governs covered entities’ (health care plans, providers, and clearinghouses)96 and their business associates’ use and disclosure of PHI.97 In addition, it establishes strong individual rights of access to an individual’s own PHI. PHI is defined as individually identifiable health information created or received by a covered entity that is transmitted by electronic media, maintained in electronic media, or transmitted or maintained in any other form or medium.98 The rule sets forth multiple situations in which covered entities may permissibly use or disclose PHI without written authorization, while generally all other uses and disclosures of PHI (i.e., those that are not expressly permitted under the rule) require an individual’s prior written authorization. Broadly, covered entities may share PHI between and among themselves for the purposes of treatment, payment, or health care operations, with few restrictions and, specifically, without the individual’s authorization.99 The Privacy Rule also recognizes that PHI may be useful or necessary in circumstances besides health care treatment and payment for a given individual or general health care operations, or entirely unrelated to health care or the health care system. For this reason, the rule lists a number of “national priority purposes” for which covered entities may disclose PHI without an individual’s authorization or opportunity to agree or object.100 Examples of these include disclosures for public health activities, health oversight, and pursuant to a requirement in law (e.g., state law). In response to the COVID-19 pandemic, the Office of Civil Rights (OCR)/HHS has issued guidance relating to the disclosure of PHI to first responders and law enforcement, as well as on telemedicine and the HIPAA Privacy Rule. OCR has also released several notifications of exercise of enforcement discretion during the COVID-19 public health emergency, specifically with respect to use and disclosure of PHI by business associates (BAs); the operation of Community-Based Testing Sites during the COVID-19 public health emergency; and the provision of care using telehealth.101 In addition, under authorities in SSA Section 1135 and the Project Bioshield Act (P.L. 108-276), the Secretary has the authority to waive sanctions and penalties for certain HIPAA Privacy Rule violations during certain emergency periods. These have been waived. The specific HIPAA Privacy Rule requirements for which penalties may be waived are as follows: (1) the requirement to distribute a notice of privacy practices (45 C.F.R. §164.520); (2) the patient’s right to request certain privacy restrictions (45 C.F.R. §164.522(a)); (3) the patient’s right to request confidential communications (45 C.F.R. §164.522(b)); (4) the requirement to honor a request to opt out of a facility directory (45 C.F.R. §164.510(a)); and (5) the requirement to obtain agreement to share information with family and friends involved in a patient’s care (45 C.F.R. §164.510(b)). These waivers apply only (1) in the emergency area identified in the public health emergency declaration and for the duration of the emergency, (2) to 96 A health care clearinghouse is defined in the Rule as: “a public or private entity, including a billing service, repricing company, community health management information system or community health information system, and ‘valueadded’ networks and switches, that does either of the following functions: (1) Processes or facilitates the processing of health information received from another entity in a nonstandard format or containing nonstandard data content into standard data elements or a standard transaction; [or] (2) Receives a standard transaction from another entity and processes or facilitates the processing of health information into nonstandard format or nonstandard data content for the receiving entity.” [45 C.F.R. §160.103] 97 45 C.F.R. 164 Subparts A and E. 98 45 C.F.R. §160.103. 99 45 C.F.R. §164.506. 100 45 C.F.R. §164.512. 101 HHS, “HIPAA, Civil Rights, and COVID-19,” https://www.hhs.gov/hipaa/for-professionals/special-topics/hipaacovid19/index.html. Congressional Research Service 27 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) those hospitals that have a disaster plan; and (3) for the first 72 hours after the hospital’s plan has been initiated.102 Provision Section 3224 requires the Secretary, not later than 180 days after enactment, to issue guidance on the sharing of patients’ PHI (as defined at 45 C.F.R. §106.103) during emergency declarations and determinations, with respect to COVID-19, pursuant to PHSA Section 319, Section 501(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act), and the National Emergencies Act. The section requires the guidance to address compliance with the HIPAA Privacy Rule and applicable policies, including any policies that may come into effect during these emergencies. Section 3225. Reauthorization of Healthy Start Program Background The Healthy Start Program (Healthy Start), which is authorized in PHSA Section 330H and administered by HRSA, is a competitive grant program.103 The program enables eligible public or private entities, community-based organizations, faith-based organizations, and Indian or tribal organizations to propose and administer innovative, community-based ways to decrease U.S. infant mortality rates (IMRs), improve perinatal and maternal health outcomes, and reduce ethnic and racial health disparities in perinatal health. (Infant mortality refers to the death of an infant before his or her first birthday. An infant mortality rate refers to the comparison of the number of infant deaths against 1,000 live births in a given year.)104 Healthy Start participants consist of women, men, infants, children, and involved parties such as family members. The program requires participants to reside in communities with IMRs that are at least 1.5 times greater than the U.S. IMR and/or have high rates of adverse perinatal outcomes such as preterm births and maternal deaths.105 The program’s authorization of appropriations, which expired in 2013, was “the amount authorized for the preceding fiscal year increased by the percentage increase in the Consumer Price Index (CPI) for all urban consumers for such year.”106 Provision Purpose and considerations in making grants. Section 3225 amends PHSA Section 330H by expanding the Healthy Start project areas to those with increasing IMRs that are above the U.S. IMR. Section 3225 removes the mandate that required applicants to include consumers of project services as participants in community-based consortiums. The Secretary instead must require applicants to include state substance abuse agencies, participants, and former participants of project areas as participants in community-based consortiums. The Secretary, when considering grant awards, is required to consider factors that contribute to infant mortality, including poor birth outcomes (e.g., low birthweight and preterm birth) and 102 HHS, “March 2020: COVID-19 and HIPAA Bulletin: Limited Waiver of HIPAA Sanctions and Penalties During a Nationwide Public Health Emergency,” https://www.hhs.gov/sites/default/files/hipaa-and-covid-19-limited-hipaawaiver-bulletin-508.pdf. 103 42 U.S.C. §254c-8; and HRSA, Healthy Start, https://mchb.hrsa.gov/maternal-child-health-initiatives/healthy-start. 104 CDC, Reproductive Health: Infant Mortality, https://www.cdc.gov/reproductivehealth/maternalinfanthealth/ infantmortality.htm. 105 HRSA, Healthy Start Initiative: Eliminating Disparities in Perinatal Health, Notice of Funding Opportunity, October 16, 2018, p. 1, https://www.hrsa.gov/grants/find-funding/hrsa-19-049. 106 42 U.S.C. §254c-8. Congressional Research Service 28 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) social determinants of health. In addition, the Secretary must consider factors such as applicants’ collaboration with the local community in developing Healthy Start projects and applicants’ use and collection of data demonstrating the program’s effectiveness in decreasing IMRs and improving perinatal outcomes. Coordination. Section 3225 makes conforming changes and moves the current language in subsection (c) to a new paragraph (1) and adds a new paragraph (2), under subsection (c). The new paragraph (2) requires the Secretary to ensure the Healthy Start program coordinates with similar programs and activities administered by HHS that aim to reduce IMRs and improve infant and perinatal health outcomes. Funding. The section authorizes an appropriation of $125.5 million for each of FY2021-FY2025, eliminates the CPI requirement, and authorizes the Secretary to reserve 1% of appropriated funds to evaluate Healthy Start projects. Section 3225 expands the Secretary’s use of the reserved funds to evaluate information related to, among other things, progress made toward meeting program metrics or health outcomes on reducing IMRs, improving perinatal outcomes, and diminishing health disparities. GAO report. Section 3225 makes conforming changes and adds a new subsection (f). The new subsection requires the Government Accountability Office (GAO) to conduct an independent evaluation of Healthy Start and to submit a report to appropriate congressional committees, no later than March 27, 2024. The section specifies that the evaluation must include a determination of whether Healthy Start projects have been effective in reducing the health disparity in health care outcomes between the general population group and racial and minority population groups, where applicable and appropriate. The report must also contain a review, an assessment, and recommendations on, among other topics, HRSA’s allocation of funding to urban and rural areas and progress towards meeting the evaluation criteria for programs that increase and decrease IMRs, improve and adversely affect perinatal outcomes, and affect disparities in infant mortality and perinatal health outcomes. Section 3226. Importance of the Blood Supply Background The nation’s blood supply is largely managed by a network of independent blood centers and the American Red Cross, with some oversight from HHS.107 These organizations collect blood product donations (e.g., whole blood, platelets) from individuals through scheduled appointments, walk-in appointments, and blood drives. The COVID-19 pandemic poses significant challenges for the United States’ blood supply. Mitigation strategies to prevent the spread of COVID-19, such as closures of schools and workplaces, have led to blood drive cancellations, resulting in a critical blood supply shortage. In addition, individuals are reluctant to schedule blood donations while advised to social distance from others.108 Provision This section requires the Secretary to carry out a national campaign to improve awareness of, and support outreach to the public and health care providers about, the importance and safety of blood 107 For more information on independent blood centers, see https://americasblood.org/about/. For more information on the American Red Cross, see https://www.redcross.org/give-blood.html. 108 For more information, see CRS Insight IN11238, Coronavirus Disease 2019 (COVID-19) Poses Challenges for the U.S. Blood Supply. Congressional Research Service 29 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) donation and the need for donations for the blood supply. The section requires the Secretary to consult with heads of relevant federal agencies (including FDA, CDC, and National Institutes of Health [NIH]), accrediting bodies, and representative organizations to carry out the campaign. In addition, the Secretary is authorized to enter into contracts with public or private nonprofit entities to carry out the campaign. The section requires the Secretary to submit a report to specified congressional committees, not later than two years from enactment that (1) describes the activities carried out, (2) describes trends in blood supply donations, and (3) evaluates the impact of the public awareness campaign. Part III—Innovation This part adds two new authorities to the broad body of law that provides incentives for medical product research and development.109 Section 3301. Removing the Cap on OTA During Public Health Emergencies Background The Biomedical Advanced Research and Development Authority (BARDA) supports the clinical research and development, regulatory approval, and procurement of new MCMs (e.g., vaccines, treatments, and diagnostics) planned for use in public health emergencies. In addition to grants, contracts, and cooperative agreements, the PHSA permits BARDA to enter into “other transactions,” which are exempt from many statutory provisions and procurement regulations. In February 2020, BARDA announced it was using its other transaction authority (OTA) to expand existing relationships with private partners to speed the development of COVID-19 countermeasures.110 In general, such transactions above $100 million require a written determination “by the Assistant Secretary for Financial Resources, that the use of such authority is essential to promoting the success of the project.”111 Provision Section 3301 amends PHSA Section 319L in a number of ways that appear to be somewhat ambiguous, but the intent seems to be to waive the requirement for a written determination for transactions above $100 million during a public health emergency declared under PHSA Section 319. Transactions made under this provision would not be terminated solely due to the expiration of the public health emergency. The Secretary is required to report the use of this provision to specified congressional committees after the public health emergency ends. Section 3302. Priority Zoonotic Animal Drugs Background 109 See, for example, CRS In Focus IF11379, Medical Product Innovation and Regulation: Benefits and Risks; and HHS Biomedical Advanced Research and Development Authority (BARDA), “BARDA’s Rapidly-Expanding COVID19 Medical Countermeasure Portfolio,” https://www.medicalcountermeasures.gov/app/barda/coronavirus/ COVID19.aspx. 110 HHS, Press Release, “HHS, Janssen Collaborate to Develop Coronavirus Therapeutics,” February 18, 2020; and HHS, Press Release, “HHS, Regeneron Collaborate to Develop 2019-nCoV Treatment,” February 4, 2020. 111 42 U.S.C. 247d-7e(c)(5)(ii)(II). Congressional Research Service 30 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) A zoonotic disease is an infectious disease that is transmissible between humans and nonhuman animals. Many emerging infections that have caused significant outbreaks among humans, are believed to have arisen from animal-to-human transmission. Drugs to treat animals are evaluated for approval by FDA. An animal origin for the COVID-19 virus is considered likely but unproven.112 Provision Section 3302 adds a new Section 512A to the FFDCA regarding Priority Zoonotic Animal Drugs. It requires the Secretary, upon an applying drug sponsor’s request, to expedite the development and review of a new animal drug “if preliminary clinical evidence indicates that the new animal drug, alone or in combination with 1 or more other animal drugs, has the potential to prevent or treat a zoonotic disease in animals, including a vector borne-disease, that has the potential to cause serious adverse health consequences for, or serious or life-threatening diseases in, humans.” The request may be made upon, or any time after, the opening of an investigational new animal drug file or filing of an application for approval, and the Secretary shall act on such request within 60 days. Actions that may be used to expedite review include expanded consultations and guidance regarding novel designs or drug development tools to make clinical trials more efficient. Part IV—Health Care Workforce PHSA Title VII authorizes a number of programs to support the health workforce. These include scholarships, loans, and academic programs that seek to diversify the workforce, train primary care providers, and increase the number of geriatric health care providers, among other things. PHSA Title VIII authorizes similar programs to support the nursing workforce. Many of Title VII and Title VIII programs were most recently reauthorized in Title V of the ACA, which made program changes, added new programs, and generally provided authorizations of appropriations through either FY2013 or FY2014. Although authorizations of appropriations for most Title VII and Title VIII have lapsed, a number of these programs have continued to receive appropriations through HRSA’s Bureau of the Health Care Workforce.113 These programs have also been considered for reauthorization in the 116th Congress, where bills would typically provide a five-year authorization of appropriations at the amounts provided in the most recent fiscal year. For example, S. 2997, Title VII Health Care Workforce Reauthorization Act of 2019,114 would have reauthorized a number of Title VII programs for five years, and would have authorized funding at FY2019 funding levels. Much of S. 2997 was included in Sections 34013403 of the CARES Act, generally with funding amounts reflective of FY2020 appropriations and with a five-year authorization that begins in FY2021. Similarly, S. 1399, Title VIII Nursing Workforce Reauthorization Act of 2019,115 would have reauthorized a number of Title VIII 112 See “Are animals responsible for COVID-19 in people?” in World Organization for Animal Health (known by its French acronym, OIE), “Questions and Answers on the 2019 Coronavirus Disease (COVID-19),” April 20, 2020, https://www.oie.int/scientific-expertise/specific-information-and-recommendations/questions-and-answers-on2019novel-coronavirus/. OIE is the intergovernmental organization responsible for analyzing and disseminating information related to animal disease control. See also CRS In Focus IF11494, Wildlife Trade, COVID-19, and Other Zoonotic Diseases. 113 For a description of the most recent reauthorization, see CRS Report R41278, Public Health, Workforce, Quality, and Related Provisions in ACA: Summary and Timeline. For FY2019 and FY2020 funding amounts, see HHS, HRSA, “Justification of Estimates for Congressional Committees, FY2021,” https://www.hrsa.gov/sites/default/files/hrsa/ about/budget/budget-justification-fy2021.pdf, pp. 17-18. 114 See version of S. 2997, as reported to the Senate on December 17, 2019. 115 See version of S. 1399, as reported to the Senate on November 5, 2019. Congressional Research Service 31 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) programs for five years, and would have authorized funding at FY2019 funding levels. Much of what was included in S. 1399 was enacted in Section 3404 of the CARES Act, with funding amounts reflective of FY2020 appropriations and with a five-year authorization that begins in FY2021. Section 3401. Reauthorization of Health Professions Workforce Programs Background PHSA Title VII authorizes a number of programs to support the health workforce. Though authorizations of appropriations for most Title VII programs have lapsed, several programs have received appropriations in recent years.116 The relevant Title VII programs (with their FY2020 appropriation level, if appropriate) are summarized below. The summary also notes other relevant PHSA Title VII advisory groups amended by this section. Centers of Excellence (Section 736) supports centers that seek to recruit, retain, and train underrepresented minorities in the health professions. The program received an appropriation of $23.711 million in FY2020. Health Professions Training for Diversity (Section 740) authorizes appropriations for a number of diversity-related training programs. Subsection (a) authorizes appropriations for scholarships for disadvantaged students (PHSA §737), which received an appropriation of $51.47 million in FY2020; subsection (b) authorizes appropriations for loan repayment and fellowships for minority health professional faculty (PHSA §738), which received an appropriation of $1.19 million in FY2020; subsection (c) authorizes appropriations for the Health Careers Opportunity Program (PHSA §739), which provides grants for programs that provide health career training to individuals from disadvantaged backgrounds. This program received an appropriation of $15 million in FY2020, and subsection (d) required a report on diversity in the health professions that was due not later than six months after enactment.117 Primary Care Training and Enhancement (Section 747) authorizes grant programs to support primary care medicine and physician assistant training. The program received an appropriation of $48.925 million in FY2020. Training in General, Pediatric, and Public Health Dentistry (PHSA Section 748) authorizes grants to support dentists and dental hygienist training. The program received an appropriation of $28 million in FY2020.118 Advisory Committee on Training in Primary Care Medicine and Dentistry (Section 749) authorizes the advisory committee that provides oversight over PHSA Section 747 and Section 748 programs. Authorizations of appropriations for those programs are contained in their respective authorizing provisions. Section 749 was renumbered in the ACA, but its language was not amended at that time. 116 For FY2019 and FY2020 funding amounts, see HHS, HRSA, “Justification of Estimates for Congressional Committees, FY2021,” https://www.hrsa.gov/sites/default/files/hrsa/about/budget/budget-justification-fy2021.pdf, pp. 17-18. 117 This section was not amended in the ACA as such, the section was enacted in November 1998, so the original report was due in 1999 (42 U.S.C. § 293(d)(d)). 118Amounts obtained from the HRSA Operating plan and have been rounded to the nearest million; see HHS, HRSA, “FY2020 Operating Plan,” https://www.hrsa.gov/about/budget/operating-plan.html. Congressional Research Service 32 Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) Area Health Education Centers (Section 751) authorizes grants for centers at medical or nursing schools that provide training for students from underserved backgrounds or in underserved (often rural) areas. This program received $41.25 million in FY2020. Quentin N. Burdick Program for Rural Interdisciplinary Training (Section 754) provided grants for interdisciplinary rural-focused health workforce training projects. This program has not been funded in the past decade and does not have a current authorization of appropriations. Allied Health and Other Disciplines (Section 755) authorizes grants to support allied health professionals. This program has not been funded in recent years. Health Workforce Information and Analysis (Section 761) established HRSA’s National Center for Health Workforce Analysis and authorizes grant programs to support state, local, and longitudinal workforce analyses. This program received an appropriation of $5.663 million in FY2020. The Council on Graduate Medical Education (COGME; Section 762) analyzes and reports to relevant congressional committees on issues related to the physician workforce, training, and the financing of training. The committee is authorized in Section 762, which lays out the committee membership and its reporting requirements. The section also specifies that the committee was to sunset in 2003; however, language in appropriations laws have waived this sunset date.119 Public Health Training Centers (Section 766) authorizes grants at public health schools to train public health professionals in health promotion and preventive medicine, among other things. This program receives its authorizations of appropriation in PHSA Section 770(a). Authorization of Appropriations (Section 770) authorizes appropriations for the group of public health workforce programs authorized in [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/crs%3AR46334. Public record. Not legal advice.