S.Amdt. 2531

SA 2531. Mr. ALEXANDER submitted an amendment intended to be proposed
to amendment SA 2499 proposed by Mr. McConnell to the bill S. 178, to
condemn gross human rights violations of ethnic Turkic Muslims in
Xinjiang, and calling for an end to arbitrary detention, torture, and
harassment of these communities inside and outside China; which was
ordered to lie on the table; as follows:

At the appropriate place, insert the following:

TITLE __IMPROVING PANDEMIC HEALTH RESPONSE

SEC. _01. IMPROVING EARLIER ACCESS TO DIAGNOSTIC TESTS.

Section 319D of the Public Health Service Act (42 U.S.C.
247d-4) is amended by adding at the end the following:
``(k) Improving Diagnostic Test, Treatment, and Vaccine
Research and Development.--
``(1) Virus sample access.--Not later than 180 days after
the date of enactment of this subsection, the Secretary
shall, in coordination with the Director of the Centers for
Disease Control and Prevention and the Commissioner of Food
and Drugs, establish and make publicly available policies and
procedures for public and private entities to access samples
of specimens containing infectious disease agents, or
suitable surrogates or alternatives, as appropriate, that may
support the development of products, including the
development of diagnostic tests, treatments, or vaccines, to
address emerging infectious diseases for biomedical research
purposes, and for use to otherwise respond to emerging
infectious diseases, as the Secretary determines appropriate.
``(2) Guidance.--The Secretary shall issue guidance
regarding the procedures for carrying out paragraph (1),
including--
``(A) the method for requesting samples of specimens
containing infectious disease agents;
``(B) criteria for sample availability and use of suitable
surrogates or alternatives, as appropriate; and
``(C) information required to be provided in order to
receive such samples or suitable surrogates or alternatives.
``(3) Earlier development of diagnostic tests.--The
Secretary, acting through the Director of the Centers for
Disease Control and Prevention, may contract with public and
private entities, as appropriate, to assist in the immediate
and rapid development, validation, and dissemination of
diagnostic tests, as appropriate, for purposes of
biosurveillance and other immediate public health response
activities to address an emerging infectious disease that has
significant potential to cause a public health emergency.
``(4) Capacity planning for supply needs.--The Secretary,
in coordination with the Commissioner of Food and Drugs and
the Director of the Centers for Disease Control and
Prevention, shall, as appropriate, consult with medical
product manufacturers, suppliers, and other relevant
stakeholders, as appropriate, to--
``(A) identify specific supplies or components needed,
including specimen collection and transport materials,
reagents, or other supplies related to the development,
validation, or administration of a diagnostic test to detect
an infectious disease for which an emergency use
authorization is in effect under section 564 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3);
``(B) identify projected demand for and availability of
such supplies and communicate such information to medical
product manufacturers, suppliers, and other relevant
stakeholders during a public health emergency; and
``(C) support activities to increase the availability of
such supplies or alternative products that may be
appropriately substituted for such supplies during a public
health emergency.''.

SEC. _02. GUIDANCE FOR STATES AND INDIAN TRIBES ON ACCESSING
THE STRATEGIC NATIONAL STOCKPILE.

Not later than 15 days after the date of enactment of this
Act, for purposes of the public health emergency declared by
the Secretary pursuant to section 319 of the Public Health
Service Act on January 31, 2020, with respect to COVID-19,
the Secretary of Health and Human Services shall issue
guidance to clarify the processes by which the Secretary of
Health and Human Services provides Federal assistance through
the Strategic National Stockpile under section 319F-2 of the
Public Health Service Act (42 U.S.C. 247d-6b) to States,
localities, territories, and Indian tribes and tribal
organizations (as defined under section 4 of the Indian Self-
Determination and Education Assistance Act). Such guidance
shall include information related to processes by which to
request access to medical supplies in the Strategic National
Stockpile and factors considered by the Secretary of Health
and Human Services when making distribution decisions.

SEC. _03. MODERNIZING INFECTIOUS DISEASE DATA COLLECTION.

(a) Improving Infectious Disease Data Collection.--Section
319D of the Public Health Service Act (42 U.S.C. 247d-4) is
amended--
(1) in subsection (c)--
(A) in paragraph (3)(A)(iv), by inserting ``(such as
commercial, academic, and other hospital laboratories)''
after ``clinical laboratories'';
(B) in paragraph (5)--
(i) in subparagraph (A)--

(I) in the matter preceding clause (i), by striking ``and
operating'' and inserting ``, operating, and updating'';
(II) in clause (iv), by striking ``and'' at the end;
(III) in clause (v), by striking the period and inserting
``; and''; and
(IV) by adding at the end the following:

``(vi) integrate and update applicable existing Centers for
Disease Control and Prevention data systems and networks in
collaboration with State, local, tribal, and territorial
public health officials, including public health surveillance
and disease detection systems.''; and

[[Page S4807]]

(ii) in subparagraph (B)--

(I) in clause (i), by inserting ``and 60 days after the
date of enactment of the Coronavirus Relief Fair Unemployment
Compensation Act of 2020'' after ``Innovation Act of 2018'';
(II) in clause (ii), by inserting ``epidemiologists,
clinical microbiologists, pathologists and laboratory
experts, experts in health information technology, privacy,
and data security'' after ``forecasting);''; and
(III) in clause (iii)--

(aa) in subclause (V), by striking ``and'' at the end;
(bb) in subclause (VI), by striking the period; and
(cc) by adding at the end the following:

``(VII) strategies to integrate laboratory and epidemiology
systems and capabilities to conduct rapid and accurate
laboratory tests;
``(VIII) strategies to improve the collection and reporting
of appropriate, aggregated, deidentified demographic data to
inform responses to public health emergencies, including
identification of at-risk populations and to address health
disparities; and
``(IX) strategies to improve the electronic exchange of
health information between State and local health departments
and health care providers and facilities to improve public
health surveillance.''; and

(C) in paragraph (6)--
(i) in subparagraph (A)--

(I) in clause (iii)--

(aa) in subclause (III), by striking ``and'' at the end;
(bb) in subclause (IV), by inserting ``, including the
ability to conduct and report on rapid and accurate
laboratory testing during a public health emergency'' before
the semicolon; and
(cc) by adding at the end the following:

``(V) improve coordination and collaboration, as
appropriate, with other Federal departments; and
``(VI) implement applicable lessons learned from recent
public health emergencies to address gaps in situational
awareness and biosurveillance capabilities, including an
evaluation of ways to improve the collection and reporting of
aggregated, deidentified demographic data to inform public
health preparedness and response'';
(II) in clause (iv), by striking ``and'' at the end;
(III) in clause (v), by striking the period and inserting
``including a description of how such steps will further the
goal of improving awareness of and timely responses to
emerging infectious disease threats; and''; and
(IV) by adding at the end the following:

``(vi) identifies and demonstrates measurable steps the
Secretary will take to further develop and integrate
infectious disease detection, including expanding
capabilities to conduct rapid and accurate diagnostic
laboratory testing during a public health emergency, and
improve coordination and collaboration with State, local,
Tribal, and territorial public health officials, clinical
laboratories (including commercial, hospital and academic
laboratories), and other entities with expertise in public
health surveillance.''; and
(ii) by redesignating subparagraph (B) as subparagraph (C);
and
(iii) by inserting after subparagraph (A), the following:
``(B) Reports.--
``(i) In general.--Not later than 1 month after date of
enactment of the Coronavirus Relief Fair Unemployment
Compensation Act of 2020, and as provided for in clause (ii),
the Secretary shall submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives, a report on the status of the Department of
Health and Human Services' biosurveillance modernization and
assessment progress with respect to emerging infectious
disease threats.
``(ii) Additional reports.--During the 2-year period
beginning on the date of enactment of the Coronavirus Relief
Fair Unemployment Compensation Act of 2020, the Secretary
shall provide additional reports under clause (i) every 90
days after the submission of the initial report under such
clause. The Secretary shall provide such reports annually
thereafter. The Secretary may provide such additional reports
less frequently, but not less frequently than every 180 days,
during an ongoing public health emergency or another
significant infectious disease outbreak.'';
(2) in subsection (d)--
(A) in paragraph (2)(C), by inserting ``, including any
public-private partnerships entered into to improve such
capacity'' before the semicolon; and
(B) in paragraph (3)--
(i) in subparagraph (B), by striking ``and'' at the end;
(ii) in subparagraph (C), by striking the period and
inserting ``; and''; and
(iii) by adding at the end the following:
``(D) may establish, enhance, or maintain a system or
network for the collection of data to provide for early
detection of infectious disease outbreaks, near real-time
access to relevant electronic data and integration of
electronic data and information from public health and other
appropriate sources, such as laboratories, hospitals, and
epidemiology systems, to enhance the capability to conduct
rapid and accurate diagnostic laboratory tests to provide for
disease detection.'';
(3) in subsection (f)(1)(A), by inserting ``pathologists,
clinical microbiologists, laboratory professionals,
epidemiologists,'' after ``forecasting),''; and
(4) in subsection (h), by adding at the end the following:
``Such evaluation shall include identification of any gaps in
biosurveillance and situational awareness capabilities
identified related to recent public health emergencies, any
immediate steps taken to address such gaps, and any long-term
plans to address such gaps, including steps related to
activities authorized under this section.''.
(b) National Health Security Strategy.--Section 2802(b)(2)
of the Public Health Service Act (42 U.S.C. 300hh-1(b)(2)) is
amended--
(1) in subparagraph (A), by inserting ``such as by
integrating laboratory and epidemiology systems and
capability to conduct rapid and accurate laboratory tests,''
after ``detection, identification,''; and
(2) in subparagraph (B), by inserting ``laboratory
testing,'' after ``services and supplies,''.
(c) Epidemiology-laboratory Capacity Grants.--Section
2821(a) of the Public Health Service Act (42 U.S.C. 300hh-
31(a)) is amended--
(1) in paragraph (3), by striking ``and'';
(2) in paragraph (4), by striking the period and inserting
``; and''; and
(3) by adding at the end the following:
``(5) supporting activities of State and local public
health departments related to biosurveillance and disease
detection, which may include activities related to section
319D, as appropriate.''.

SEC. _04. CENTERS FOR PUBLIC HEALTH PREPAREDNESS.

(a) In General.--Subpart B of title III of the Public
Health Service Act (42 U.S.C. 243 et seq.) is amended by
inserting after section 319F-4 the following:

``SEC. 319F-5. CENTERS FOR PUBLIC HEALTH PREPAREDNESS.

``(a) In General.--The Secretary may award grants,
contracts, or cooperative agreements to institutions of
higher education or other nonprofit private entities for the
establishment or support of a network of regional centers for
public health preparedness (referred to in this section as
`Centers').
``(b) Use of Funds.--Centers established or supported under
this section shall--
``(1) advance the awareness of public health officials,
health care professionals, and the public, with respect to
information and research related to public health
preparedness and response, including for chemical,
biological, radiological, and nuclear threats, including
emerging infectious diseases, and epidemiology of emerging
infectious diseases;
``(2) identify and translate promising research findings or
practices into evidence-based practices to inform
preparedness for, and responses to, a chemical, biological,
radiological, or nuclear agent, including emerging infectious
diseases;
``(3) expand activities, including through public-private
partnerships, as appropriate, related to public health
preparedness and response, including participation in drills
and exercises and training public health experts, as
appropriate; and
``(4) provide technical assistance and expertise, as
applicable, during public health emergencies, including for
emerging infectious disease threats, which may include
identifying and communicating evidence on the impacts of such
threats on at-risk populations.
``(c) Requirements.--To be eligible for an award under this
section, an entity shall submit to the Secretary an
application containing such information as the Secretary may
require, including a description of how the entity will--
``(1) coordinate activities with State, local, and tribal
health departments, hospitals, and health care coalitions,
including recipients of awards under section 319C-1, 319C-2,
or 319C-3, in order to improve preparedness, integrate
capabilities and functions, and reduce duplication; and
``(2) prioritize efforts to implement evidence-based
practices to improve public health preparedness and reduce
the spread of emerging infectious disease threats.
``(d) Distribution of Awards.--In awarding grants,
contracts, or cooperative agreements under this section, the
Secretary shall support not fewer than 10 regional centers
for public health preparedness, subject to the availability
of appropriations.
``(e) Authorization.--For purposes of carrying out this
section, there are authorized to be appropriated such sums as
may be necessary for each of fiscal years 2021 through
2025.''.
(b) Conforming Changes.--Section 319F of the Public Health
Service Act (42 U.S.C. 247d-6) is amended--
(1) by striking subsection (d); and
(2) by redesignating subsections (e) and (f) as subsections
(d) and (e), respectively.

SEC. _05. TELEHEALTH PLANS.

(a) PHSA.--Title XXVII of the Public Health Service Act (42
U.S.C. 300gg et seq.) is amended--
(1) in section 2722(c) (42 U.S.C. 300gg-21(c)), by adding
at the end the following:
``(4) Telehealth benefits.--
``(A) In general.--The requirements of subparts I and II
(except section 2704 (relating to the prohibition of
preexisting condition exclusions or other discrimination
based on health status), section 2705 (relating to
prohibition of discrimination against individual participants
and beneficiaries based on health status), section 2712
(relating to prohibition of rescissions); and section 2726

[[Page S4808]]

(relating to parity in mental health or substance use
disorder benefits) and as provided by the Secretary in
guidance) shall not apply to any group health plan (or group
health insurance coverage) offered by a large employer in
relation to its provision of excepted benefits described in
section 2791(c)(5) if the benefits--
``(i) are provided in accordance with guidance issued by
the Secretary; and
``(ii) are made available only to employees (and dependents
of such employees) who are not eligible for another group
health plan or group health insurance coverage offered by the
employer offering such benefits described in section
2791(c)(5).
``(B) Sunset.--This paragraph shall have no force or effect
with respect to plan years beginning on or after the later
of--
``(i) January 1, 2022; or
``(ii) the date on which the public health emergency
declared by the Secretary under section 319, on January 31,
2020, with respect to COVID-19 ends.''; and
(2) in section 2791(c) (42 U.S.C. 300gg-91(c)), by adding
at the end the following:
``(5) Benefits for telehealth services only.--
``(A) In general.--Benefits for telehealth services and
other remote care services only, as specified in the guidance
entitled, `FAQs about Families First Coronavirus Response Act
and Coronavirus Aid, Relief, and Economic Security Act
Implementation Part 43', issued by the Secretary, the
Secretary of Labor, and the Secretary of the Treasury on June
23, 2020 (or any successor guidance).
``(B) Sunset.--This paragraph shall have no force or effect
with respect to plan years beginning on or after the later
of--
``(i) January 1, 2022; or
``(ii) the date on which the public health emergency
declared by the Secretary under section 319, on January 31,
2020, with respect to COVID-19 ends.''.
(b) Application Under ERISA and the IRC.--Section
2722(c)(4) of the Public Health Service Act (as amended by
subsection (a)) shall apply to group health plans and health
insurance issuers providing health insurance coverage in
connection with group health plans pursuant to part 7 of
subtitle B of title I of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1181 et seq.), and pursuant
to chapter 100 of subtitle K of the Internal Revenue Code of
1986, as though such section 2722(c)(4) were included in such
part and such chapter, respectively.
(c) Implementation.--The Secretary of Health and Human
Services, the Secretary of Labor, and the Secretary of the
Treasury may implement the provisions of this section,
including the amendments made by this section, through sub-
regulatory guidance, program instruction, or otherwise.

SEC. _06. PROTECTION OF HUMAN GENETIC INFORMATION.

(a) In General.--Notwithstanding any other provision of
law, the Secretary of Health and Human Services shall ensure
that no person may collect, store, analyze, disseminate, or
otherwise make use of, or benefit from, any human genetic
information collected as a result of diagnostic and serologic
testing for COVID-19, for any incidental use, or any reason
other than such diagnostic or serologic testing, except with
the express, written, informed consent of the individual
being tested.
(b) Enforcement.--Any person who violates subsection (a)
shall be subject to a civil monetary penalty of not more than
$100 for each such violation.
(c) Definitions.--In this section--
(1) the term ``genetic information'' has the meaning given
such term in section 160.103 of title 45, Code of Federal
Regulations (or any successor regulations); and
(2) the term ``incidental'' means any action taken by any
person, directly or indirectly, to obtain genetic information
from an individual, for any purpose, other than the purpose
specifically authorized by the living individual from whom
the specimen has its biological origin or another designated
individual if the individual is a minor or is incapacitated,
or if the individual is deceased, the individual's next of
kin.

SEC. _07. REAGAN-UDALL FOUNDATION AND FOUNDATION FOR THE
NATIONAL INSTITUTES OF HEALTH.

(a) Reagan-Udall Foundation for the Food and Drug
Administration.--Section 770(n) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379dd(n)) is amended by striking
``$500,000 and not more than $1,250,000'' and inserting
``$1,250,000 and not more than $5,000,000''.
(b) Foundation for the National Institutes of Health.--
Section 499(l) of the Public Health Service Act (42 U.S.C.
290b(l)) is amended by striking ``$500,000 and not more than
$1,250,000'' and inserting ``$1,250,000 and not more than
$5,000,000''.
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