Amendment SA 2531 to S. 178 on Improving Pandemic Health Response — Congressional Record, Senate
Summary
This is page S4806 of the Congressional Record, Senate, August 4, 2020, printing amendment SA 2531, submitted by Mr. Alexander to amendment SA 2499 proposed by Mr. McConnell to the bill S. 178. The amendment is titled Improving Pandemic Health Response and amends the Public Health Service Act on diagnostic tests and the Strategic National Stockpile. It authorizes $1,000,000,000 for each of fiscal years 2021 through 2030 for State medical stockpiles and appropriates $10,000,000,000 for fiscal year 2021, available until September 30, 2030. It also directs the Secretary of Health and Human Services to issue guidance to States and Indian tribes on accessing the stockpile within 15 days of enactment.
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“Amendment SA 2531 to S. 178 on Improving Pandemic Health Response — Congressional Record, Senate.”
Original at www.govinfo.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/crec-crec-2020-08-04-crec-2020-08-04-pt1-pgs4806-db01f8df62/
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S4806 CONGRESSIONAL RECORD — SENATE August 4, 2020
‘‘(C) WITHHOLDING OF CERTAIN AMOUNTS ‘‘(ii) maintaining domestic manufacturing validation, and dissemination of diagnostic
FROM ENTITIES THAT FAIL TO ACHIEVE BENCH- capacity of such products to ensure addi- tests, as appropriate, for purposes of bio-
MARKS OR SUBMIT STATE STOCKPILE PLAN.— tional reserved production capacity of such surveillance and other immediate public
Beginning with fiscal year 2022, and in each products is available, and that such products health response activities to address an
succeeding fiscal year, the Secretary shall are provided in a timely manner, to be deliv- emerging infectious disease that has signifi-
withhold from each entity that has failed ered to the ownership of the Federal Govern- cant potential to cause a public health emer-
substantially to meet the terms of an award ment under the contract and deployed in the gency.
under this subsection for at least 1 of the 2 event that the Secretary determines that ‘‘(4) CAPACITY PLANNING FOR SUPPLY
immediately preceding fiscal years (begin- there is a need to quickly purchase addi- NEEDS.—The Secretary, in coordination with
ning with fiscal year 2022), the amount al- tional quantities of such product; and the Commissioner of Food and Drugs and the
lowed for administrative expenses described ‘‘(B) promulgate such regulations as the Director of the Centers for Disease Control
in described in paragraph (2)(D). Secretary determines necessary to imple- and Prevention, shall, as appropriate, con-
‘‘(9) AUTHORIZATION OF APPROPRIATIONS.— ment this paragraph.’’; and sult with medical product manufacturers,
For the purpose of carrying out this sub- (E) in subparagraph (A) of paragraph (6), as suppliers, and other relevant stakeholders,
section, there are authorized to be appro- so redesignated— as appropriate, to—
priated $1,000,000,000 for each of fiscal years (i) in clause (viii), by striking ‘‘; and’’ and ‘‘(A) identify specific supplies or compo-
2021 through 2030, to remain available until inserting a semicolon; nents needed, including specimen collection
expended. (ii) in clause (ix), by striking the period and transport materials, reagents, or other
‘‘(10) ADVANCE APPROPRIATION.— and inserting ‘‘; and’’; and supplies related to the development, valida-
‘‘(A) IN GENERAL.—There is appropriated, (iii) by adding at the end the following: tion, or administration of a diagnostic test
out of amounts in the Treasury not other- ‘‘(x) an assessment of the contracts or co- to detect an infectious disease for which an
wise appropriated, for fiscal year 2021, for operative agreements entered into pursuant emergency use authorization is in effect
necessary expenses to establish and maintain to paragraph (5).’’; and under section 564 of the Federal Food, Drug,
State medical stockpiles pursuant to this (2) in subsection (c)(2)(C), by striking ‘‘on and Cosmetic Act (21 U.S.C. 360bbb–3);
subsection, $10,000,000,000, to remain avail- an annual basis’’ and inserting ‘‘not later ‘‘(B) identify projected demand for and
able until September 30, 2030. than March 15 of each year’’. availability of such supplies and commu-
‘‘(B) EMERGENCY DESIGNATION.— nicate such information to medical product
‘‘(i) IN GENERAL.—The amounts provided by SA 2531. Mr. ALEXANDER submitted manufacturers, suppliers, and other relevant
this paragraph are designated as an emer- an amendment intended to be proposed stakeholders during a public health emer-
gency requirement pursuant to section 4(g) to amendment SA 2499 proposed by Mr. gency; and
of the Statutory Pay-As-You-Go Act of 2010 MCCONNELL to the bill S. 178, to con- ‘‘(C) support activities to increase the
(2 U.S.C. 933(g)). demn gross human rights violations of availability of such supplies or alternative
‘‘(ii) DESIGNATION IN SENATE.—In the Sen- ethnic Turkic Muslims in Xinjiang, and products that may be appropriately sub-
ate, this paragraph is designated as an emer- stituted for such supplies during a public
gency requirement pursuant to section
calling for an end to arbitrary deten- health emergency.’’.
4112(a) of H. Con. Res. 71 (115th Congress), the tion, torture, and harassment of these SEC. l02. GUIDANCE FOR STATES AND INDIAN
concurrent resolution on the budget for fis- communities inside and outside China; TRIBES ON ACCESSING THE STRA-
cal year 2018. which was ordered to lie on the table; TEGIC NATIONAL STOCKPILE.
‘‘(C) APPLICATION OF PROVISIONS.—Amounts as follows: Not later than 15 days after the date of en-
appropriated pursuant to this paragraph for At the appropriate place, insert the fol- actment of this Act, for purposes of the pub-
fiscal year 2021 shall be subject to the re- lowing: lic health emergency declared by the Sec-
quirements contained in Public Law 116–94 retary pursuant to section 319 of the Public
TITLE llIMPROVING PANDEMIC HEALTH Health Service Act on January 31, 2020, with
for funds for programs authorized under sec- RESPONSE
tion 319F–2 of this Act.’’. respect to COVID–19, the Secretary of Health
SEC. l01. IMPROVING EARLIER ACCESS TO DIAG- and Human Services shall issue guidance to
SEC. l04. STRENGTHENING THE STRATEGIC NA- NOSTIC TESTS.
TIONAL STOCKPILE.
clarify the processes by which the Secretary
Section 319D of the Public Health Service of Health and Human Services provides Fed-
Section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–4) is amended by adding eral assistance through the Strategic Na-
Act (42 U.S.C. 247d–6b) is amended— at the end the following: tional Stockpile under section 319F–2 of the
(1) in subsection (a)— ‘‘(k) IMPROVING DIAGNOSTIC TEST, TREAT- Public Health Service Act (42 U.S.C. 247d–6b)
(A) in paragraph (2)(A), by adding ‘‘and the MENT, AND VACCINE RESEARCH AND DEVELOP- to States, localities, territories, and Indian
contracts issued under paragraph (5)’’ after MENT.— tribes and tribal organizations (as defined
‘‘paragraph (1)’’; ‘‘(1) VIRUS SAMPLE ACCESS.—Not later than under section 4 of the Indian Self-Determina-
(B) in paragraph (3)(F), by striking ‘‘Sec- 180 days after the date of enactment of this tion and Education Assistance Act). Such
retary of Homeland Security’’ and inserting subsection, the Secretary shall, in coordina- guidance shall include information related
‘‘Secretary of Health and Human Services, in tion with the Director of the Centers for Dis- to processes by which to request access to
coordination with or at the request of, the ease Control and Prevention and the Com- medical supplies in the Strategic National
Secretary of Homeland Security,’’; missioner of Food and Drugs, establish and Stockpile and factors considered by the Sec-
(C) by redesignating paragraph (5) as para- make publicly available policies and proce- retary of Health and Human Services when
graph (6); dures for public and private entities to ac- making distribution decisions.
(D) by inserting after paragraph (4) the fol- cess samples of specimens containing infec- SEC. l03. MODERNIZING INFECTIOUS DISEASE
lowing: tious disease agents, or suitable surrogates DATA COLLECTION.
‘‘(5) SURGE CAPACITY.—The Secretary, in or alternatives, as appropriate, that may (a) IMPROVING INFECTIOUS DISEASE DATA
maintaining the stockpile under paragraph support the development of products, includ- COLLECTION.—Section 319D of the Public
(1) and carrying out procedures under para- ing the development of diagnostic tests, Health Service Act (42 U.S.C. 247d-4) is
graph (3), may— treatments, or vaccines, to address emerging amended—
‘‘(A) enter into contracts or cooperative infectious diseases for biomedical research (1) in subsection (c)—
agreements with vendors for procurement, purposes, and for use to otherwise respond to (A) in paragraph (3)(A)(iv), by inserting
maintenance, and storage of reserve amounts emerging infectious diseases, as the Sec- ‘‘(such as commercial, academic, and other
of drugs, vaccines and other biological prod- retary determines appropriate. hospital laboratories)’’ after ‘‘clinical lab-
ucts, medical devices, and other medical sup- ‘‘(2) GUIDANCE.—The Secretary shall issue oratories’’;
plies (including personal protective equip- guidance regarding the procedures for car- (B) in paragraph (5)—
ment, ancillary medical supplies, and other rying out paragraph (1), including— (i) in subparagraph (A)—
applicable supplies required for the adminis- ‘‘(A) the method for requesting samples of (I) in the matter preceding clause (i), by
tration of drugs, vaccines and other biologi- specimens containing infectious disease striking ‘‘and operating’’ and inserting ‘‘, op-
cal products, medical devices, and diagnostic agents; erating, and updating’’;
tests in the stockpile), under such terms and ‘‘(B) criteria for sample availability and (II) in clause (iv), by striking ‘‘and’’ at the
conditions (including quantity, production use of suitable surrogates or alternatives, as end;
schedule, maintenance costs, and price of appropriate; and (III) in clause (v), by striking the period
product) as the Secretary may specify, in- ‘‘(C) information required to be provided in and inserting ‘‘; and’’; and
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cluding for purposes of— order to receive such samples or suitable sur- (IV) by adding at the end the following:
‘‘(i) maintenance and storage of reserve rogates or alternatives. ‘‘(vi) integrate and update applicable exist-
amounts of products intended to be delivered ‘‘(3) EARLIER DEVELOPMENT OF DIAGNOSTIC ing Centers for Disease Control and Preven-
to the ownership of the Federal Government TESTS.—The Secretary, acting through the tion data systems and networks in collabora-
under the contract, which may consider Director of the Centers for Disease Control tion with State, local, tribal, and territorial
costs of shipping, or otherwise transporting, and Prevention, may contract with public public health officials, including public
handling, storage, and related costs for such and private entities, as appropriate, to assist health surveillance and disease detection
product or products; and in the immediate and rapid development, systems.’’; and
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August 4, 2020 CONGRESSIONAL RECORD — SENATE S4807
(ii) in subparagraph (B)— tives, a report on the status of the Depart- ‘‘SEC. 319F–5. CENTERS FOR PUBLIC HEALTH
(I) in clause (i), by inserting ‘‘and 60 days ment of Health and Human Services’ bio- PREPAREDNESS.
after the date of enactment of the surveillance modernization and assessment ‘‘(a) IN GENERAL.—The Secretary may
Coronavirus Relief Fair Unemployment progress with respect to emerging infectious award grants, contracts, or cooperative
Compensation Act of 2020’’ after ‘‘Innovation disease threats. agreements to institutions of higher edu-
Act of 2018’’; ‘‘(ii) ADDITIONAL REPORTS.—During the 2- cation or other nonprofit private entities for
(II) in clause (ii), by inserting ‘‘epidemiolo- year period beginning on the date of enact- the establishment or support of a network of
gists, clinical microbiologists, pathologists ment of the Coronavirus Relief Fair Unem- regional centers for public health prepared-
and laboratory experts, experts in health in- ployment Compensation Act of 2020, the Sec- ness (referred to in this section as ‘Centers’).
formation technology, privacy, and data se- retary shall provide additional reports under ‘‘(b) USE OF FUNDS.—Centers established or
curity’’ after ‘‘forecasting);’’; and clause (i) every 90 days after the submission supported under this section shall—
(III) in clause (iii)— of the initial report under such clause. The ‘‘(1) advance the awareness of public health
(aa) in subclause (V), by striking ‘‘and’’ at Secretary shall provide such reports annu- officials, health care professionals, and the
the end; ally thereafter. The Secretary may provide public, with respect to information and re-
(bb) in subclause (VI), by striking the pe- such additional reports less frequently, but search related to public health preparedness
riod; and not less frequently than every 180 days, dur- and response, including for chemical, bio-
(cc) by adding at the end the following: ing an ongoing public health emergency or logical, radiological, and nuclear threats, in-
‘‘(VII) strategies to integrate laboratory another significant infectious disease out- cluding emerging infectious diseases, and ep-
and epidemiology systems and capabilities break.’’; idemiology of emerging infectious diseases;
to conduct rapid and accurate laboratory (2) in subsection (d)— ‘‘(2) identify and translate promising re-
tests; (A) in paragraph (2)(C), by inserting ‘‘, in- search findings or practices into evidence-
‘‘(VIII) strategies to improve the collection cluding any public-private partnerships en- based practices to inform preparedness for,
and reporting of appropriate, aggregated, tered into to improve such capacity’’ before and responses to, a chemical, biological, ra-
deidentified demographic data to inform re- the semicolon; and diological, or nuclear agent, including
sponses to public health emergencies, includ- (B) in paragraph (3)— emerging infectious diseases;
ing identification of at-risk populations and (i) in subparagraph (B), by striking ‘‘and’’ ‘‘(3) expand activities, including through
to address health disparities; and at the end; public-private partnerships, as appropriate,
‘‘(IX) strategies to improve the electronic (ii) in subparagraph (C), by striking the pe- related to public health preparedness and re-
exchange of health information between riod and inserting ‘‘; and’’; and sponse, including participation in drills and
State and local health departments and (iii) by adding at the end the following: exercises and training public health experts,
health care providers and facilities to im- ‘‘(D) may establish, enhance, or maintain a as appropriate; and
prove public health surveillance.’’; and system or network for the collection of data ‘‘(4) provide technical assistance and ex-
(C) in paragraph (6)— to provide for early detection of infectious pertise, as applicable, during public health
(i) in subparagraph (A)— disease outbreaks, near real-time access to emergencies, including for emerging infec-
(I) in clause (iii)— relevant electronic data and integration of tious disease threats, which may include
(aa) in subclause (III), by striking ‘‘and’’ at electronic data and information from public identifying and communicating evidence on
the end; the impacts of such threats on at-risk popu-
health and other appropriate sources, such
(bb) in subclause (IV), by inserting ‘‘, in- lations.
as laboratories, hospitals, and epidemiology
cluding the ability to conduct and report on ‘‘(c) REQUIREMENTS.—To be eligible for an
systems, to enhance the capability to con-
rapid and accurate laboratory testing during award under this section, an entity shall
duct rapid and accurate diagnostic labora-
a public health emergency’’ before the semi- submit to the Secretary an application con-
tory tests to provide for disease detection.’’;
colon; and taining such information as the Secretary
(3) in subsection (f)(1)(A), by inserting ‘‘pa-
(cc) by adding at the end the following: may require, including a description of how
thologists, clinical microbiologists, labora-
‘‘(V) improve coordination and collabora- the entity will—
tory professionals, epidemiologists,’’ after
tion, as appropriate, with other Federal de- ‘‘(1) coordinate activities with State, local,
‘‘forecasting),’’; and
partments; and and tribal health departments, hospitals, and
‘‘(VI) implement applicable lessons learned (4) in subsection (h), by adding at the end
health care coalitions, including recipients
from recent public health emergencies to ad- the following: ‘‘Such evaluation shall in-
of awards under section 319C–1, 319C–2, or
dress gaps in situational awareness and bio- clude identification of any gaps in bio-
319C–3, in order to improve preparedness, in-
surveillance capabilities, including an eval- surveillance and situational awareness capa-
tegrate capabilities and functions, and re-
uation of ways to improve the collection and bilities identified related to recent public
duce duplication; and
reporting of aggregated, deidentified demo- health emergencies, any immediate steps
‘‘(2) prioritize efforts to implement evi-
graphic data to inform public health pre- taken to address such gaps, and any long-
dence-based practices to improve public
paredness and response’’; term plans to address such gaps, including
health preparedness and reduce the spread of
(II) in clause (iv), by striking ‘‘and’’ at the steps related to activities authorized under
emerging infectious disease threats.
end; this section.’’. ‘‘(d) DISTRIBUTION OF AWARDS.—In award-
(III) in clause (v), by striking the period (b) NATIONAL HEALTH SECURITY STRAT- ing grants, contracts, or cooperative agree-
and inserting ‘‘including a description of how EGY.—Section 2802(b)(2) of the Public Health ments under this section, the Secretary shall
such steps will further the goal of improving Service Act (42 U.S.C. 300hh-1(b)(2)) is support not fewer than 10 regional centers
awareness of and timely responses to emerg- amended— for public health preparedness, subject to the
ing infectious disease threats; and’’; and (1) in subparagraph (A), by inserting ‘‘such availability of appropriations.
(IV) by adding at the end the following: as by integrating laboratory and epidemi- ‘‘(e) AUTHORIZATION.—For purposes of car-
‘‘(vi) identifies and demonstrates measur- ology systems and capability to conduct rying out this section, there are authorized
able steps the Secretary will take to further rapid and accurate laboratory tests,’’ after to be appropriated such sums as may be nec-
develop and integrate infectious disease de- ‘‘detection, identification,’’; and essary for each of fiscal years 2021 through
tection, including expanding capabilities to (2) in subparagraph (B), by inserting ‘‘lab- 2025.’’.
conduct rapid and accurate diagnostic lab- oratory testing,’’ after ‘‘services and sup- (b) CONFORMING CHANGES.—Section 319F of
oratory testing during a public health emer- plies,’’. the Public Health Service Act (42 U.S.C.
gency, and improve coordination and col- (c) EPIDEMIOLOGY-LABORATORY CAPACITY 247d–6) is amended—
laboration with State, local, Tribal, and ter- GRANTS.—Section 2821(a) of the Public (1) by striking subsection (d); and
ritorial public health officials, clinical lab- Health Service Act (42 U.S.C. 300hh-31(a)) is (2) by redesignating subsections (e) and (f)
oratories (including commercial, hospital amended— as subsections (d) and (e), respectively.
and academic laboratories), and other enti- (1) in paragraph (3), by striking ‘‘and’’; SEC. l05. TELEHEALTH PLANS.
ties with expertise in public health surveil- (2) in paragraph (4), by striking the period (a) PHSA.—Title XXVII of the Public
lance.’’; and and inserting ‘‘; and’’; and Health Service Act (42 U.S.C. 300gg et seq.) is
(ii) by redesignating subparagraph (B) as (3) by adding at the end the following: amended—
subparagraph (C); and ‘‘(5) supporting activities of State and (1) in section 2722(c) (42 U.S.C. 300gg–21(c)),
(iii) by inserting after subparagraph (A), local public health departments related to by adding at the end the following:
the following: biosurveillance and disease detection, which ‘‘(4) TELEHEALTH BENEFITS.—
‘‘(B) REPORTS.— ‘‘(A) IN GENERAL.—The requirements of
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may include activities related to section
‘‘(i) IN GENERAL.—Not later than 1 month 319D, as appropriate.’’. subparts I and II (except section 2704 (relat-
after date of enactment of the Coronavirus ing to the prohibition of preexisting condi-
Relief Fair Unemployment Compensation SEC. l04. CENTERS FOR PUBLIC HEALTH PRE- tion exclusions or other discrimination based
PAREDNESS.
Act of 2020, and as provided for in clause (ii), on health status), section 2705 (relating to
the Secretary shall submit to the Committee (a) IN GENERAL.—Subpart B of title III of prohibition of discrimination against indi-
on Health, Education, Labor, and Pensions of the Public Health Service Act (42 U.S.C. 243 vidual participants and beneficiaries based
the Senate and the Committee on Energy et seq.) is amended by inserting after section on health status), section 2712 (relating to
and Commerce of the House of Representa- 319F–4 the following: prohibition of rescissions); and section 2726
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S4808 CONGRESSIONAL RECORD — SENATE August 4, 2020
(relating to parity in mental health or sub- (2) the term ‘‘incidental’’ means any action emergency period described in section
stance use disorder benefits) and as provided taken by any person, directly or indirectly, 1135(g)(1)(B),’’ after ‘‘January 1, 2019,’’; and
by the Secretary in guidance) shall not apply to obtain genetic information from an indi- (E) in paragraph (7), by inserting ‘‘and
to any group health plan (or group health in- vidual, for any purpose, other than the pur- prior to the first day after the end of the
surance coverage) offered by a large em- pose specifically authorized by the living in- emergency period described in section
ployer in relation to its provision of excepted dividual from whom the specimen has its bi- 1135(g)(1)(B),’’ after ‘‘July 1, 2019,’’.
benefits described in section 2791(c)(5) if the ological origin or another designated indi- (b) EXPANDING PRACTITIONERS ELIGIBLE TO
benefits— vidual if the individual is a minor or is inca- FURNISH TELEHEALTH SERVICES.—Section
‘‘(i) are provided in accordance with guid- pacitated, or if the individual is deceased, 1834(m) of the Social Security Act (42 U.S.C.
ance issued by the Secretary; and the individual’s next of kin. 1395m(m)) is amended—
‘‘(ii) are made available only to employees SEC. l07.
REAGAN-UDALL FOUNDATION AND (1) in paragraph (1), by striking ‘‘(described
(and dependents of such employees) who are FOUNDATION FOR THE NATIONAL in section 1842(b)(18)(C))’’ and inserting ‘‘(de-
not eligible for another group health plan or INSTITUTES OF HEALTH. fined in paragraph (4)(E))’’; and
group health insurance coverage offered by (a) REAGAN-UDALL FOUNDATION FOR THE (2) in paragraph (4)(E)—
the employer offering such benefits described FOOD AND DRUG ADMINISTRATION.—Section (A) by striking ‘‘PRACTITIONER.—The term’’
in section 2791(c)(5). 770(n) of the Federal Food, Drug, and Cos- and inserting ‘‘PRACTITIONER.—
‘‘(B) SUNSET.—This paragraph shall have metic Act (21 U.S.C. 379dd(n)) is amended by ‘‘(A) IN GENERAL.—Subject to subparagraph
no force or effect with respect to plan years striking ‘‘$500,000 and not more than (B), the term’’; and
beginning on or after the later of— $1,250,000’’ and inserting ‘‘$1,250,000 and not (B) by adding at the end the following new
‘‘(i) January 1, 2022; or more than $5,000,000’’. subparagraph:
(b) FOUNDATION FOR THE NATIONAL INSTI- ‘‘(B) EXPANSION.—The Secretary, after con-
‘‘(ii) the date on which the public health
TUTES OF HEALTH.—Section 499(l) of the Pub-
emergency declared by the Secretary under sulting with stakeholders regarding services
lic Health Service Act (42 U.S.C. 290b(l)) is that are clinically appropriate, may expand
section 319, on January 31, 2020, with respect amended by striking ‘‘$500,000 and not more
to COVID–19 ends.’’; and the types of practitioners who may furnish
than $1,250,000’’ and inserting ‘‘$1,250,000 and
(2) in section 2791(c) (42 U.S.C. 300gg–91(c)), telehealth services to include any health
not more than $5,000,000’’.
by adding at the end the following: care professional that is eligible to bill the
‘‘(5) BENEFITS FOR TELEHEALTH SERVICES SA 2532. Mr. ALEXANDER submitted program under this title for their profes-
ONLY.— sional services.’’.
an amendment intended to be proposed (c) RETENTION OF ADDITIONAL SERVICES AND
‘‘(A) IN GENERAL.—Benefits for telehealth to amendment SA 2499 proposed by Mr.
services and other remote care services only, SUBREGULATORY PROCESS FOR MODIFICATIONS
as specified in the guidance entitled, ‘FAQs
MCCONNELL to the bill S. 178, to con- FOLLOWING EMERGENCY PERIOD.—Section
about Families First Coronavirus Response demn gross human rights violations of 1834(m)(4)(F) of the Social Security Act (42
Act and Coronavirus Aid, Relief, and Eco- ethnic Turkic Muslims in Xinjiang, and U.S.C. 1395m(m)(4)(F)) is amended—
nomic Security Act Implementation Part 43’, calling for an end to arbitrary deten- (1) in clause (i), by inserting ‘‘and clause
issued by the Secretary, the Secretary of tion, torture, and harassment of these (iii)’’ after ‘‘paragraph (8)’’;
Labor, and the Secretary of the Treasury on communities inside and outside China; (2) in clause (ii), by striking ‘‘The Sec-
June 23, 2020 (or any successor guidance). which was ordered to lie on the table; retary’’ and inserting ‘‘Subject to clause
‘‘(B) SUNSET.—This paragraph shall have (iii), the Secretary’’; and
as follows: (3) by adding at the end the following new
no force or effect with respect to plan years At the appropriate place, insert the fol-
beginning on or after the later of— clause:
lowing: ‘‘(iii) RETENTION OF ADDITIONAL SERVICES
‘‘(i) January 1, 2022; or SEC. ll. EXTENDING MEDICARE TELEHEALTH
‘‘(ii) the date on which the public health AND SUBREGULATORY PROCESS FOR MODIFICA-
FLEXIBILITIES.
emergency declared by the Secretary under TIONS FOLLOWING EMERGENCY PERIOD.—With
(a) EXPANDING ACCESS TO TELEHEALTH
section 319, on January 31, 2020, with respect respect to telehealth services furnished after
SERVICES.—
to COVID–19 ends.’’. the last day of the emergency period de-
(1) IN GENERAL.—Section 1834(m)(4)(C) of
(b) APPLICATION UNDER ERISA AND THE scribed in section 1135(g)(1)(B), the Secretary
the Social Security Act (42 U.S.C.
IRC.—Section 2722(c)(4) of the Public Health may—
1395m(m)(4)(C)) is amended by adding at the
Service Act (as amended by subsection (a)) ‘‘(I) retain as appropriate the expanded list
end the following new clause:
shall apply to group health plans and health of telehealth services specified in clause (i)
‘‘(iii) EXPANDING ACCESS TO TELEHEALTH
insurance issuers providing health insurance pursuant to the waiver authority under sec-
SERVICES.—With respect to telehealth serv-
coverage in connection with group health tion 1135(b)(8) during such emergency period;
ices furnished beginning on the first day
plans pursuant to part 7 of subtitle B of title and
after the end of the emergency period de-
I of the Employee Retirement Income Secu- ‘‘(II) retain the subregulatory process used
scribed in section 1135(g)(1)(B) of this clause,
rity Act of 1974 (29 U.S.C. 1181 et seq.), and to modify the services included on the list of
the term ‘originating site’ means any site at
pursuant to chapter 100 of subtitle K of the such telehealth services pursuant to clause
which the eligible telehealth individual is lo-
Internal Revenue Code of 1986, as though (ii) during such emergency period.’’.
cated at the time the service is furnished via (d) ENHANCING TELEHEALTH SERVICES FOR
such section 2722(c)(4) were included in such
a telecommunications system, including the FEDERALLY QUALIFIED HEALTH CENTERS AND
part and such chapter, respectively.
(c) IMPLEMENTATION.—The Secretary of home of an individual.’’. RURAL HEALTH CLINICS.—Section 1834(m)(8)
Health and Human Services, the Secretary of (2) CONFORMING AMENDMENTS.—Such sec- of the Social Security Act (42 U.S.C.
Labor, and the Secretary of the Treasury tion is amended— 1395m(m)(8)) is amended—
may implement the provisions of this sec- (A) in paragraph (2)(B)— (1) in the paragraph heading by inserting
tion, including the amendments made by (i) in clause (i), in the matter preceding ‘‘AND AFTER’’ after ‘‘DURING ’’;
this section, through sub-regulatory guid- subclause (I), by striking ‘‘clause (ii)’’ and (2) in subparagraph (A), in the matter pre-
ance, program instruction, or otherwise. inserting ‘‘clauses (ii) and (iii)’’; and ceding clause (i), by inserting ‘‘and after’’
SEC. l06. PROTECTION OF HUMAN GENETIC IN- (ii) by adding at the end the following new after ‘‘During’’; and
FORMATION. clause: (3) in the first sentence of subparagraph
(a) IN GENERAL.—Notwithstanding any ‘‘(iii) NO FACILITY FEE FOR NEW SITES.— (B)(i), by inserting ‘‘and after’’ after ‘‘dur-
other provision of law, the Secretary of With respect to telehealth services furnished ing’’.
Health and Human Services shall ensure that on or after the date of enactment of this (e) USE OF TELEHEALTH, AS CLINICALLY AP-
no person may collect, store, analyze, dis- clause, a facility fee shall only be paid under PROPRIATE, TO CONDUCT FACE-TO-FACE EN-
seminate, or otherwise make use of, or ben- this subparagraph to an originating site that COUNTER FOR HOSPICE CARE.—Section
efit from, any human genetic information is described in paragraph (4)(C)(ii) (other 1814(a)(7)(D)(i)(II) of the Social Security Act
collected as a result of diagnostic and sero- than subclause (X) of such paragraph).’’. (42 U.S.C. 1395f(a)(7)(D)(i)(II)) is amended by
logic testing for COVID–19, for any inci- (B) in paragraph (4)(C)— inserting ‘‘and after such emergency period
dental use, or any reason other than such di- (i) in clause (i), in the matter preceding as clinically appropriate’’ after
agnostic or serologic testing, except with the subclause (I), by inserting ‘‘and clause (iii)’’ ‘‘1135(g)(1)(B)’’.
express, written, informed consent of the in- after ‘‘and (7)’’; and (f) USE OF TELEHEALTH, AS CLINICALLY AP-
dividual being tested. (ii) in clause (ii)(X), by inserting ‘‘prior to PROPRIATE, TO CONDUCT FACE-TO-FACE CLIN-
(b) ENFORCEMENT.—Any person who vio- the first day after the end of the emergency ICAL ASSESSMENTS FOR HOME DIALYSIS.—
SSpencer on DSK126QN23PROD with SENATE
lates subsection (a) shall be subject to a civil period described in section 1135(g)(1)(B)’’ be- Clause (iii) of section 1881(b)(3)(B) of the So-
monetary penalty of not more than $100 for fore the period; cial Security Act (42 U.S.C. 1395rr(b)(3)(B)) is
each such violation. (C) in paragraph (5), by inserting ‘‘and amended—
(c) DEFINITIONS.—In this section— prior to the first day after the end of the (1) by moving such clause 4 ems to the left;
(1) the term ‘‘genetic information’’ has the emergency period described in section and
meaning given such term in section 160.103 of 1135(g)(1)(B)’’ after ‘‘January 1, 2019,’’; (2) by inserting ‘‘and after such emergency
title 45, Code of Federal Regulations (or any (D) in paragraph (6)(A), by inserting ‘‘and period as clinically appropriate’’ before the
successor regulations); and prior to the first day after the end of the period.
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