Selected Health Provisions in Title III of the CARES Act (P.L. 116-136)
Congressional research reportApr 29, 2020
Ask Donna
What actually matters in this document.
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 PHSA Sections 765-770. Public health workforce
programs received an appropriation of $17 million in FY2020.
Pediatric Subspecialty Loan Repayment Program (Section 775) authorizes loan repayment to
specific pediatric subspecialists (including behavioral health specialists) in exchange for a service
requirement in underserved areas. This program was created in the ACA but has never been
funded or implemented.
Provision
This section extends authorizations of appropriations for a number of sections in PHSA Title VII.
In each case, appropriations are authorized for each of FY2021-FY2025. The section reauthorizes
the health workforce diversity programs as follows:
$23.711 million for PHSA Section 736,
$51.470 million PHSA Section 740(a),
$1.19 million for PHSA Section 740(b), and
$15 million for PHSA Section 740(c).
The section also amends the date of a report on diversity in the health professions required in
PHSA Section 740(d) to require that the report is due to the appropriate congressional committees
not later than September 30, 2025, and every five years thereafter.
The section also amends and extends the authorizations of appropriations for a number of
programs related to primary care medical and dental training, as specified below.
119 For FY2020, this was included in Title II of Division A of P.L. 116-94.
Congressional Research Service
33
Selected Health Provisions in Title III of the CARES Act (P.L. 116-136)
The section amends PHSA Section 747, which authorizes training programs for
primary care physicians and physician assistants. The section makes the
following changes: (1) removes reference to demonstration projects in grants
related to innovative care models; (2) amends granting priorities to permit the
Secretary to give preference to qualified applicants that train residents in rural
areas, including for Tribes or Tribal Organizations that are located in rural areas;
(3) changes references from “substance-related disorders” to “substance use
disorders;”120 and (4) authorizes an appropriation of $48.294 million annually for
each of FY2021-FY2025.
The section amends PHSA Section 748, which authorizes training programs for
general, pediatric, and public health dentists and dental hygienists; it changes
references from “substance-related disorders” to “substance use disorders” and
authorizes an appropriation of $28.531 million for each of FY2021-FY2025.
The section amends PHSA Section 749(d), which authorizes the Advisory
Committee on Training in Primary Care Medicine and Dentistry, to update
references to congressional committees to reflect the current committee names.
The section amends PHSA Section 751, which authorizes the Area Health
Education Center program, to authorize an appropriation of $41.25 million for
each of FY2021-FY2025.
The section amends PHSA Section 754, which authorizes the Quentin N. Burdick
Program for Rural Interdisciplinary Training, to revise language related to using
grant funds by replacing “new and innovate” with “innovative or evidencebased.”
The section amends in PHSA Section 755, which authorizes grants for training in
Allied Health and Other Disciplines to replace language related to the elderly
with reference to “geriatric populations or for maternal and child health.”
The section amends PHSA Section 761, which authorized Health Workforce
Information and Analysis, to authorize to be appropriated $5.663 million
annually for each of FY2021-FY2025.
The section amends PHSA Section 762 (COGME) to update references to
congressional committees to reflect the current committee names; change
language from the Health Care Financing Administration to CMS; make
conforming changes; add the HRSA Administrator to the council; delete language
related to reports required at COGME’s outset and the council’s termination; and
add new reporting requirement dates. Specifically, it requires a report to be
delivered to specified congressional committees not later than September 30,
2023, and not less than every five years thereafter.
The section amends PHSA Section 766 (Public Health Training Centers) to delete
language related to Healthy People 2000 and to add language related to rural
areas.
The section amends PHSA Section 770 (Authorization of Appropriations), which
authorizes appropriations for Public Health Workforce Programs, to authorize
$17 million to be appropriated for each of FY2021-FY2025.
120 CARES Act Section 3401, and other sections in the law, replace references to substance abuse with “substance use
disorders” to reflect contemporary terminology used in the field and align language in the law with the most current
version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
Congressional Research Service
34
Selected Health Provisions in Title III of the CARES Act (P.L. 116-136)
The section amends PHSA Section 775 (Loan Repayment for Pediatric
Subspecialists) to authorize such sums as may be necessary for each of FY2021FY2025.
Section 3402. Health Workforce Coordination
Background
HRSA administers a number of health workforce programs through its Bureau of Health
Workforce. A number of these programs also have advisory committees that advise HRSA and
Congress about specific programs (e.g., the Advisory Committee on Training in Primary Care
Medicine and Dentistry provides oversight of programs authorized in Sections 747 and 748
related to primary care medicine and dental training).121 Each of these advisory groups has a
specific charge or scope, and their work is generally not coordinated. For example, although
COGME evaluates graduate medical education (GME) policy, the bulk of GME funding is from
CMS, while the relevant advisory group is administered through HRSA. Experts have
recommended the need for more coordinated GME and overall health workforce policy as a way
to better focus federal health workforce investments across the federal government.122
Provision
This section requires the Secretary, in consultation with the Advisory Committee on Training in
Primary Care Medicine and Dentistry and the COGME, to develop a comprehensive plan that
coordinates HHS’s health care workforce development programs. The plan must include certain
specified elements such as performance measures, as specified; gap analyses and plans to rectify
these gaps; and barriers to implementing strategies to rectify the identified gaps. It also requires
the Secretary to coordinate with other federal agencies and departments that administer relevant
education and training programs. The purpose of such coordination is to evaluate whether these
programs are meeting U.S. health workforce needs and identify opportunities to improve
information collected to better inform program improvements. Finally, the section requires the
Secretary to submit a report describing the comprehensive health workforce plan and its
implementation to specified congressional committees no later than two years after enactment.
Section 3403. Education and Training Relating to Geriatrics
Background
PHSA Section 753 authorizes a number of geriatric workforce programs. Separately, PHSA
Section 865 authorizes similar geriatric workforce programs focused on nurses, because nurses
are generally not eligible for programs in Title VII. Beginning in FY2015, HRSA opted to
consolidate and administer these geriatric workforce programs together and has since supported
two training programs: the Geriatrics Workforce Enhancement Program (GWEP) and the
Geriatrics Academic Career Awards (GACA).123 GWEP provides grants to create training
programs that focus on training inter-professional teams to increase geriatric competence among
121 For information on HRSA advisory committees, see HHS, HRSA, “Federal Advisory Committees,”
https://www.hrsa.gov/advisory-committees/index.html.
122 See discussion in CRS Report R44376, Federal Support for Graduate Medical Education: An Overview. See also
discussion of Sec. 5101 in CRS Report R41278, Public Health, Workforce, Quality, and Related Provisions in ACA:
Summary and Timeline.
123 HHS, HRSA, “Justification of Estimates for Congressional Committees, FY2015,” pp. 136-143 and pp. 188-191.
Congressional Research Service
35
Selected Health Provisions in Title III of the CARES Act (P.L. 116-136)
primary care and other types of health care providers.124 GACA makes awards to institutions on
behalf of junior (non-tenured) faculty to support the career development of academic geriatricians
in medicine, pharmacy, nursing, social work, and other health professions. The expectation is that
GACA award recipients will provide inter-professional clinical training and become leaders in
academic geriatrics.
PHSA Section 753 was most recently reauthorized in the ACA, which added a number of new
subsections within the section that authorized new geriatric training programs. These new
programs were never implemented. Appropriations were authorized through FY2014, with the
exception of the Geriatric Career Incentive Award program, which had been authorized through
FY2013.125 Despite the lapsed authorization of appropriations, these programs have been funded
in recent years; most recently they received $40.737 million in FY2020. 126
Provision
This section replaces PHSA Section 753 with a new PHSA Section 753, “Education and Training
Related to Geriatrics.” The new section codifies two existing geriatric workforce training
programs: (1) GWEP and (2) GACA. It deletes existing unfunded geriatric training programs.
The section, in new subsection (a) requires the Secretary to award grants, contracts, or
cooperative agreements to specified health professional schools, including schools of allied
health, nursing schools, and programs that focus on geriatric education, to establish GWEPs. It
specifies the GWEP requirements that include health trainee support, and an emphasis on patient
and family engagement and primary care integration. The section also specifies the activities that
GWEP programs are authorized to provide, including specific types of training and Alzheimer’s
disease education. The section specifies that GWEP grants may not be awarded for more than five
years; that applicants must submit an application, as specified; and that the Secretary is required
to use certain awarding priorities but may also take into account specified awarding
considerations. Finally, with regard to the GWEP program, the section specifies grantee reporting
requirements, requires the Secretary to report to specified congressional committees not later than
four years after the enactment of Title VII Health Care Workforce Reauthorization Act of 2019
and every five years thereafter, and requires that the report be made publicly available.127
New PHSA Section 753(b) establishes the GACA grant program where grants are awarded to
eligible entities to support their geriatric careers. The section defines the entities eligible for
GACA awards, including nursing schools and the health professionals who are eligible to receive
support. The section also specifies that academics must be junior non-tenured faculty at the time
the award is made, but that they remain eligible for the award if they receive tenure during the
award period. The section specifies the application requirements and the assurances regarding
service requirements that the application must contain. It specifies that, when making awards, the
Secretary is required to ensure a geographical distribution among award recipients, including
among rural MUAs. The section also specifies that grants must be a minimum of $75,000 in
124 HHS, HRSA, “Justification of Estimates for Congressional Committees, FY2015,” https://ww.hrsa.gov/sites/default/
files/hrsa/about/budget/budget-justification-fy2021.pdf, p.122.
125 For a description of the most recent reauthorization, see CRS Report R41278, Public Health, Workforce, Quality,
and Related Provisions in ACA: Summary and Timeline.
126 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,
p.18.
127 The reference to the Title VII Health Care Workforce Reauthorization Act of 2019 appears to be a drafting error;
however, this provision was included, with changes to the authorization date and amounts, in S. 2997, Title VII Health
Care Workforce Reauthorization Act of 2019. See version of S. 2997, as reported to the Senate on December 17, 2019.
Congressional Research Service
36
Selected Health Provisions in Title III of the CARES Act (P.L. 116-136)
FY2021, to increase annually by the CPI thereafter; that award periods may not exceed five years;
and the service requirement that awardees must fulfill as a condition of receiving an award.
Finally, for both GWEP and GACA, the section waives certain awarding preferences that
otherwise apply to Title VII grants, and it authorizes to be appropriated $40.737 million for each
of FY2021-FY2025.
Section 3404. Nursing Workforce Development
Background
PHSA Title VIII authorizes a number of nursing workforce programs. Part A provides general
provisions of the title, including definitions and entities eligible for the grants made available
under the title. Part B authorizes grant programs to support advance practice nurses, including
nurse practitioners, nurse anesthetists, and nurse midwives. Part C authorizes grant programs that
seek to increase nursing workforce diversity, and Part D authorizes grant programs that aim to
strengthen the nursing workforce and improve nursing practice. This effort includes programs that
seek to expand the nursing career ladder whereby individuals in lower skilled health professions
receive training and education to advance in the nursing field (e.g., from a nursing assistant to a
registered nurse). Finally, Part E establishes the nursing student loan program. These programs
were most recently reauthorized in the ACA, with authorizations of appropriations through
FY2013 or FY2014.128 Despite the lapsed authorization, these programs have been funded in
recent years. Specifically, in FY2020, they received an appropriation of $260 million.129
Provision
This section reauthorizes programs in PHSA Title VIII in subsection (a), while subsection (b)
requires a GAO report on nursing loan programs.
General Provisions. Subsection (a) makes the following changes to Title VIII. It adds nursemanaged health clinics to the definition of entities eligible for grants authorized in Title VIII;
adds new language to applications (in Section 802), to use of funds (in Section 803), and to
provisions that are generally applicable to Title VIII (Section 806). Specifically, the subsection
adds new language that grants should be awarded to address national nursing needs, as specified;
to require new information from grantees; and to add new language requiring a biennial report
that includes certain specified elements to be delivered not later than September 30, 2020, to
specified congressional committees. The subsection also makes a number of changes to Section
811 (grants for advance education nursing grants) to replace language that references master’s
level nurses to graduate level nurses, to change language referencing clinical nurse leaders to
nurse administrators, and to add that clinical nurse specialist programs, as specified, are eligible
for grants under this section.
Nurse Education, Quality, and Retention Grants. The subsection amends Section 831 to
rename the section “Nurse Education, Quality, and Retention Grants.” It also amends the
description of practice priority groups and retention priority areas within the nursing career ladder
by adding language, that among other things, specifies that grants help individuals, including
health aides or community health practitioners certified under the IHS Community Health Aide
Program, enter the nursing career ladder. It adds language to Section 831 specifying that grants
128 For a description of the most recent reauthorization, see CRS Report R41278, Public Health, Workforce, Quality,
and Related Provisions in ACA: Summary and Timeline.
129 For FY2019 and FY2020 funding amounts, see HHS, HRSA, “Justification of Estimates for Congressional
Committees, FY2021,” https://www.hrsa.gov/site.fault/files/hrsa/about/budget/budget-justification-fy2021.pdf, p. 18.
Congressional Research Service
37
Selected Health Provisions in Title III of the CARES Act (P.L. 116-136)
may be used to develop and implement fellowship and residency programs and to encourage the
mentoring and development of nursing specialties. It also deletes subsection (e), referring to grant
awards preferences in prior years, and (h), which had authorized appropriations from FY2010FY2014, and renumbers the subsection accordingly. The subsection also amends the reporting
requirements in Section 831 to require the Secretary to submit a report on the grants in this
section as part of a larger report required under Section 806, and expands the entities eligible for
grants under this section to add, in addition to nursing schools, health care facilities, Federally
Qualified Health Centers (FQHCs), nurse-managed health clinics, and a partnership of such a
school and facility.
Deletions. The subsection deletes PHSA Section 831A (Nurse Retention Grants), because grants
for this purpose are now included in the amended PHSA Section 831. It then amends PHSA
Section 846 (Loan Repayment and Scholarship Program) to permit individuals to fulfill their
service commitment and for-profit health facilities, to make language gender neutral, and to
remove the sections authorization of appropriation and make reference to an amount allocated
under PHSA Section 871(b). The section also deletes the separate authorization of appropriations
from PHSA Section 846A (Nurse Faculty Loans) and Section 847 (Eligible Individual Student
Loan Repayment); adds language referencing clinical nurse specialists to PHSA Section 851
(National Advisory Council on Nurse Education and Practice); amends the committees that the
council is required to report to update to current committee names; and amends language related
to amounts available to fund the council’s activities. The section also deletes PHSA Section 861
(Public Service Announcements) and PHSA Section 862 (State and Local Public Service
Announcements).
Appropriation Changes. Finally, the subsection amends Section 871, which authorizes
appropriations for the title to authorize $137.837 million for each of FY2021-FY2025 to carry out
Parts B, C, and D of Title VIII and to authorize $117.135 million for each of FY2021-FY2025 to
carry out Part E (Student Loan Funds).
Subsection (b) of the provision requires a GAO report that evaluates nurse loan repayment
programs, as specified, to be delivered to specified congressional committees, no later than 18
months after enactment.
Subtitle D—Finance Committee
Subtitle D makes a series of changes in the Medicare and Medicaid programs in response to the
COVID-19 public health emergency declared by the Secretary. The Medicare provisions increase
certain payments to providers, including hospitals; expand the use of allowable telehealth
services; make any potential COVID-19 vaccine available under Medicare Part B without costsharing; and relax certain program requirements to make it easier for Medicare patients to obtain
certain services. The provisions also address cost-sharing to states for Medicaid services.
Section 3701. Exemption for Telehealth Services
Background
A health savings account (HSA) is a tax-advantaged account that individuals can use to pay for
unreimbursed medical expenses (e.g., deductibles, co-payments, coinsurance, and services not
covered by insurance).130
130 For more information on health savings accounts (HSAs), see CRS Report R45277, Health Savings Accounts
(HSAs).
Congressional Research Service
38
Selected Health Provisions in Title III of the CARES Act (P.L. 116-136)
Individuals are eligible to establish and contribute to an HSA if they have coverage under an
HSA-qualified high-deductible health plan (HDHP), do not have disqualifying coverage, and
cannot be claimed as a dependent on another person’s tax return.
To be considered an HSA-qualified HDHP, a health plan must meet several criteria: (1) it must
have a deductible above a certain minimum level, (2) it must limit out-of-pocket expenditures for
covered benefits to no more than a certain maximum level, and (3) it can cover only preventive
care services before the deductible is met.
For example, if a health plan satisfies the first two of the aforementioned criteria and provides
coverage for preventive care services and prescription drugs before the deductible is met, that
health plan would not be considered an HSA-qualified HDHP because it provides prescription
drug benefits before the deductible is met.
Disqualifying coverage is generally considered any other health coverage that is not an HSAqualified HDHP or that provides coverage for any benefit that is covered under their HSAqualified HDHP.
Provision
Section 3701 amends Internal Revenue Code (IRC) Section 223(c) for plan years beginning on or
before December 31, 2021, to allow HSA-qualified HDHPs to provide “telehealth and other
remote care services” before the deductible is met and still be considered an HSA-qualified
HDHP.
For plan years beginning on or before December 31, 2021, Section 3701 provides that telehealth
and other remote care would not be considered disqualifying coverage that would prevent an
otherwise eligible individual from being considered HSA-eligible.
These provisions were effective upon the date of enactment (i.e., March 27, 2020).
Section 3702. Inclusion of Certain Over-The-Counter Medical Products as
Qualified Medical Expenses
Background
There are four categories of health-related tax-advantaged accounts/arrangements: HSAs, Archer
medical savings accounts (Archer MSAs), flexible spending arrangements (FSAs), and health
reimbursement arrangements (HRAs). Distributions from HSAs and Archer MSAs and
reimbursements from FSAs and HRAs that are used to pay for qualified medical expenses are not
taxed.
Each account/arrangement category has a different set of medical expenses that would be
considered a qualified medical expense, but all accounts/arrangements generally consider, at a
minimum, the following as qualified medical expenses: the costs of diagnosis, cure, mitigation,
treatment, or prevention of disease and the costs for treatments affecting any part of the body; the
amounts paid for transportation to receive medical care; and qualified long-term care services.
Most recently, OTC medicines and drugs (other than insulin) were not considered a qualified
medical expense for any account/arrangement category unless an individual received a
corresponding prescription for each non-prescribed expense.
Provision
Section 3702 amends Sections 106, 220(d)(2)(A), and 223(d)(2) of the IRC to allow OTC
medicines and drugs (without a prescription) and menstrual care products to be considered
Congressional Research Service
39
Selected Health Provisions in Title III of the CARES Act (P.L. 116-136)
qualified medical expenses for HSAs, Archer MSAs, FSAs, and HRAs. This change in the
definition of qualified medical expenses applies to amounts paid or expenses incurred after
December 31, 2019.
Section 3703. Increasing Medicare Telehealth Flexibilities During
Emergency Period
Background
Medicare coverage under Part B (fee-for-service) for telehealth services is defined under SSA
Section 1834(m), which places certain conditions on such care, including who can furnish and be
paid for the service, where the patient is located (the originating site), where the physician is
located (the distant site), and the types of services that are covered. Recent legislation has
modified some of the conditions under which telehealth services may be furnished under
Medicare. The Coronavirus Preparedness and Response Supplemental Appropriations Act (P.L.
116-123) Division B, Section 102, added certain Medicare telehealth restrictions to the list of
applicable conditions for which the Secretary could temporarily waive or modify program
requirements or regulations during the COVID-19 emergency. The provision also defined a
qualified telehealth provider, requiring a prior relationship within the past three years between the
patient and the provider under Medicare. Subsequently, FFCRA Division F, Section 6010,
expanded the definition of a qualified provider to include those who had provider-patient
relationships within the past three years outside of Medicare.
Provision
Section 3703 removes the list of telehealth restrictions the Secretary was allowed to waive under
P.L. 116-123 and broadens the Secretary’s authority to temporarily waive any of the SSA Section
1834(m) telehealth requirements. The provision also removes the definition of a “qualified
provider” for telehealth services during the COVID-19 emergency period pursuant to SSA
Section 1135. The provision strikes the specific subsection added under P.L. 116-123 related to
telephone use, such that the waiver authority applies more broadly to include “a telehealth service
[…] furnished in any emergency area (or portion of such an area) during any portion of any
emergency period to an individual.” In addition, removing the “qualified provider” definition
eliminates the requirement of a prior relationship between the patient and the provider for
telehealth services to be delivered and covered under the COVID-19 emergency declaration.
Section 3704. Enhancing Medicare Telehealth Services for Federally Qualified
Health Centers and Rural Health Clinics During Emergency Period
Background
Under current law, FQHCs and rural health clinics (RHCs) are allowed to be originating sites for
covered telehealth services (sites where a patient is located) but are not allowed to be distant sites,
where physicians may provide telehealth services to eligible patients at other locations
(originating sites). Generally, both FQHC and RHCs are not paid under the Medicare physician
fee schedule (MPFS). Rather, FQHCs are paid through an FQHC-specific prospective payment
system (PPS), while RHCs are reimbursed as an all-inclusive rate for the services they provide.
Provision
Section 3704 allows FQHCs and RHCs to serve as distant sites for the furnishing of telehealth
services to telehealth-eligible individuals during the emergency period. The Secretary is required
Congressional Research Service
40
Selected Health Provisions in Title III of the CARES Act (P.L. 116-136)
to develop and implement, through program instruction or otherwise, payment methods for this
purpose that apply to FQHCs and RHCs serving as a distant sites that furnish telehealth services
to eligible telehealth individuals during such an emergency period. Such services are to be paid
similar to the national average amount for comparable telehealth services under the MPFS. The
costs associated with this care are not to be included when calculating the payments for the
FQHC PPS or the RHC all-inclusive rates, under current law.
Section 3705. Temporary Waiver of Requirement for Face-To-Face Visits Between
Home Dialysis Patients and Physicians
Background
Medicare is the main source of health care coverage for Americans with end-stage renal disease
(ESRD). Individuals with ESRD have substantial and permanent loss of kidney function and
require either a regular course of dialysis (a process that removes harmful waste products from an
individual’s bloodstream) or a kidney transplant to survive. Medicare covers beneficiaries aged
65 and older who have ESRD, as well as qualified individuals with ESRD who are under the age
of 65.131
Medicare ESRD benefits include thrice-weekly dialysis treatment and coverage for kidney
transplants. CMS pays physicians, typically nephrologists, and other practitioners a monthly perpatient rate for most dialysis-related services. Physicians and practitioners managing ESRD
patients who perform home-based dialysis are paid a single monthly rate based on the ESRD
beneficiary’s age. A physician or practitioner is required to have at least one face-to-face visit
with a home dialysis patient each month.132
As part of the Bipartisan Budget Act of 2018 (BBA 2018; P.L. 115-123), Congress expanded the
use of telehealth services for ESRD patients undergoing home dialysis. Starting in 2019, ESRD
beneficiaries who use home dialysis have been allowed to receive monthly face-to-face clinical
assessments via telehealth services, so long as the beneficiaries receive a face-to-face assessment
without the use of telehealth (1) at least monthly for the initial three months of home dialysis, and
(2) after the initial three months, at least once every three consecutive months.
Provision
Section 3705 amends SSA Section 1881(b)(3)(B) to allow the Secretary to waive the requirement
that to receive telehealth services, a Medicare ESRD beneficiary undergoing home dialysis
receive a face-to-face clinical assessment from a practitioner monthly during the initial three
months of home dialysis and once every three months thereafter. The requirement may be waived
for the period that the COVID-19 emergency is in effect.
Section 3706. Use of Telehealth to Conduct Face-To-Face Encounter Prior to
Recertification of Eligibility for Hospice Care During Emergency Period
Background
The Medicare hospice benefit provides coverage for certain services provided to Medicare
beneficiaries with a life expectancy of six months or less. Such services must be rendered by
131 Social Security Amendments of 1972; P.L. 92-603.
132 CRS Report R45290, Medicare Coverage of End-Stage Renal Disease (ESRD).
Congressional Research Service
41
Selected Health Provisions in Title III of the CARES Act (P.L. 116-136)
Medicare-certified hospices, which are either public agencies or private organizations primarily
engaged in providing hospice services.
Although beneficiaries who elect hospice care may disenroll from the hospice benefit at any time,
the benefit is administratively structured by “periods”: specifically, two 90-day periods and an
unlimited number of subsequent 60-day periods. For hospice care to be covered under Medicare,
an initial certification of a terminal illness must be obtained by the hospice at the beginning of the
first 90-day period of care. The initial certification requires signed declarative statements attesting
to the presence of a terminal illness by the hospice physician and the beneficiary’s attending
physician, if the individual has designated one. For each subsequent period of hospice care,
recertification of the beneficiary’s terminal illness is required only by the hospice physician.
Since the beginning of 2011, part of the recertification process to determine continued eligibility
has included a mandatory face-to-face encounter with the beneficiary by the hospice physician or
nurse practitioner.
Provision
Section 3706 amends SSA Section 1814(a)(7)(D)(i) to provide that, as determined appropriate by
the Secretary, a hospice physician or nurse practitioner may conduct a face-to-face encounter for
continued eligibility purposes via telehealth during a period that the COVID-19 emergency is in
effect.
Section 3707. Encouraging Use of Telecommunications Systems for Home Health
Services Furnished During Emergency Period
Background
Medicare covers visits by participating home health agencies for beneficiaries who (1) are
confined to home and (2) need either skilled nursing care on an intermittent basis, physical
therapy, or speech language therapy. As required by SSA Section 1895, home health agencies are
paid for services under a home health PPS based on 30-day episodes of care. Generally, the home
health PPS consists of a nationwide payment amount that is subject to adjustments for the
expected care needs of a beneficiary (i.e., case-mix) and differences in local wages. Further
payment adjustments are made in certain situations, including a low-utilization payment
adjustment (LUPA) for episodes of care with few home visits.133
Under SSA Section 1895, home health agencies are not precluded from adopting telemedicine or
other technologies, but such services are not permitted to serve as a substitute for visits paid
under the home health PPS. Accordingly, federal regulations define a home health visit as an
episode of personal contact. As such, telemedicine services are not accounted for in the home
health PPS, nor do providers receive direct payment for telemedicine services generally.
Although there is no direct payment for home health services provided through remote
technologies, regulations in 42 C.F.R. Part 409.46 designate remote patient monitoring as a
service with costs that may be reported as administrative if remote patient monitoring is used to
augment the care planning process. Remote patient monitoring is defined in regulations as the
collection of patient health information that is digitally stored or transmitted by the patient and/or
caregiver to the home health agency. CMS allows home health agencies to include the costs of
remote patient monitoring as an allowable administrative cost.
133 CRS Report R40425, Medicare Primer.
Congressional Research Service
42
Selected Health Provisions in Title III of the CARES Act (P.L. 116-136)
Provision
Section 3707 requires the Secretary to consider how HHS can encourage the use of telemedicine
by home health agencies with respect to home health services provided to Medicare beneficiaries
during the period that the COVID-19 emergency is in effect. Specifically, the Secretary is
required to consider ways to encourage the use of telecommunications systems, including for
remote patient monitoring, and other communications or monitoring services. Use of new
technologies must be consistent with the plan of care for beneficiaries. As part of this
consideration, the Secretary may clarify guidance and conduct outreach, as appropriate.
Section 3708. Improving Care Planning for Medicare Home Health Services
Background
Medicare covers certain home health services under both Parts A and B.134 Special eligibility
requirements and benefit limits exist for home health services furnished under Part A to
beneficiaries who are enrolled in both Parts A and B. For such beneficiaries, Part A pays for only
“postinstitutional” home health services, provided for up to 100 visits during a “spell of illness,”
which is a period that extends 14 days after a discharge from a skilled nursing facility or a
hospital following a minimum stay of three consecutive days. Part B covers any medically
necessary home health services that exceed the 100-visit limit, as well as medically necessary
home health services that do not qualify as “postinstitutional.”
For beneficiaries enrolled in only Part A or Part B, the requirements described above do not apply.
Part A or Part B, as applicable, covers all medically necessary episodes of home health care
without a visit limit, regardless of whether the episode of care follows a hospitalization. Whether
a beneficiary is enrolled in Part A only, Part B only, or in both, the scope of the Medicare home
health benefit is the same. Medicare’s payments to home health agencies are calculated using the
same methods, and beneficiaries have no cost-sharing.
As required under SSA Sections 1814 and 1835 (for Parts A and Part B, respectively), for a
beneficiary to receive home health services under Medicare, certain eligibility requirements must
be certified by a physician, including a face-to-face encounter performed by a physician or a
specified medical professional working in collaboration with, or under the supervision of, the
physician, as applicable. For a beneficiary to be eligible for coverage, the physician certifies that
home health services are required because the beneficiary, under the care of the physician, is (1)
confined to the home and (2) in need of either skilled nursing care on an intermittent basis,
physical therapy, or speech language therapy. After this eligibility is established, the eligibility
period may be continued for homebound beneficiaries with a certified continuing need for
occupational therapy services.
A physician is prohibited from certifying home health eligibility if he or she has a significant
ownership interest in, or a significant financial or contractual relationship with, the home health
agency in which the services are to be provided. These conditions are delineated in federal
regulations and include an authorized exception for instances in which there is a solitary
community home health agency.
BBA 2018, Section 51002, amended SSA Sections 1814 and 1835 to expand the scope of
supporting documentation the Secretary may use to document Medicare eligibility for home
health services. Under the BBA changes, in addition to using a physician’s medical record or a
134 For more information on the Medicare program, including the services covered under each part, see CRS Report
R40425, Medicare Primer.
Congressional Research Service
43
Selected Health Provisions in Title III of the CARES Act (P.L. 116-136)
record compiled by an acute/post-acute facility, the Secretary may also use a home health
agency’s medical record as appropriate to the case involved.
Provision
Section 3708 amends SSA Section 1814(a)(2)(C) and Section 1835(a)(2)(A) to allow, no later
than six months after enactment, a nurse practitioner, clinical nurse specialist, or physician
assistant to certify the eligibility requirements for Medicare home health services under Parts A
and B, respectively. Section 3708 further allows a nurse practitioner, clinical nurse specialist, or
physician assistant to conduct the required face-to-face encounter that is part of the certification
process.
Section 3708 also amends SSA Sections 1814 and 1835 to prohibit such professionals with a
significant financial stake in a home health agency from certifying beneficiary eligibility when
that agency is the entity providing the necessary services. However, the same exemption exists as
the one pertaining to certifying physicians: the prohibition is waived if the servicing entity is the
sole community home health agency. Further, Section 3708 conforms to language in the BBA
2018 to allow the Secretary to use a home health agency’s medical record, in addition to a
medical record compiled by medical professionals with certification authority, to document
eligibility as appropriate to a specific case.
Section 3708 also amends SSA Sections 1861 and 1895 to ensure that the general definitions of
home health services, coverage, and payment system encompass and conform with current
statutory language referencing the medical professionals to whom certification authority is
extended. In addition, amendments made under Section 3708 are applied under SSA Title XIX
(Medicaid) in the same manner and to the same extent such requirements apply to Medicare
under SSA Title XVIII or regulations promulgated thereunder.
No later than six months after enactment, the Secretary is required to implement regulations
relevant to application of the amendments. If necessary, the Secretary must produce an interim
final rule to comply with the required six-month effective date.
Section 3709. Adjustment of Sequestration
Background
The Budget Control Act of 2011 (BCA; P.L. 112-25) provided for increases in the debt limit and
established procedures designed to reduce the federal budget deficit, including the creation of the
Joint Select Committee on Deficit Reduction. The failure of the Joint Committee to propose
deficit reduction legislation that was subsequently enacted into law by its mandated deadline
triggered automatic spending reductions, including the “sequestration” (i.e., across-the-board
reductions) of mandatory
This text is long and has been trimmed here. Open the source document for the complete record.
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.